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Consumer Health
A Guide to Intelligent Decisions
9TH EDITION
STEPHEN BARRETT WILLIAM M. LONDON MANFRED KROGER
HARRIET HALL ROBERT S. BARATZ
9TH EDITION
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BARRETT LONDON KROGER HALL
BARATZ
Make Good Decisions about Your Health Care The most comprehensive consumer health text available, Consumer Health: A Guide to Intelligent Decisions offers a panoramic view of the health marketplace. You’ll learn how to sharpen your critical consumer skills so you can distinguish valid health claims from those that are fraudulent or misleading. By offering science-based facts and guidelines, Consumer Health provides the tools you need to make smart decisions about health care products and services for yourself and your family.
Some of the many new and revised topics include:
Updated information on health care economics, refl ecting the most recent legislation and debates regarding insurance and mandatory coverage and how it affects you.
New and expanded material on complementary and alternative medicine, including the latest on fad diseases, “energy medicine,” accreditation standards, and diploma mills.
Current research and information on nutrition and weight management, including “detox” products, the Dietary Guidelines for Americans 2010, and the newly-designed MyPlate food guide.
About the Authors
Stephen Barrett, M.D., has been investigating and writing about consumer health issues for more than 40 years. His Quackwatch website serves as a clearinghouse for information on health frauds and quackery. He serves as Vice President of the Institute for Science in Medicine, is a Fellow of the Committee for Skeptical Inquiry, edits Consumer Health Digest, and is a peer-review panelist for several top medical journals.
William M. London, Ed.D., M.P.H., is a health educator and professor in the Department of Public Health at California State University, Los Angeles. He is also the associate editor of Consumer Health Digest, co-host of the Credential Watch website, and a member of the editorial board of the journal FACT (Focus on Alternative and Complementary Therapies: An Evidence-Based Approach).
Manfred Kroger, Ph.D., is Professor Emeritus of Food Science and Professor Emeritus of Science, Technology and Society at The Pennsylvania State University, where he has won several teaching awards. He is a science communicator for the Institute of Food Technologists and is scientifi c editor of its online journal, Comprehensive Reviews in Food Science and Food Safety. He is also associate editor of the Journal of Food Science and a scientifi c advisor to the American Council on Science and Health.
Harriet Hall, M.D., a retired family physician and colonel, served 20 years in the U.S. Air Force. Her administrative positions included chief of clinic services and director of base medical services. She now devotes her time to investigating questionable health claims and writing and lecturing about pseudoscience, quackery, “alternative medicine,” and critical thinking. She is a contributing editor to both Skeptical Inquirer and Skeptic magazines and a founding member and editor of the Science-Based Medicine blog.
Robert S. Baratz, M.D., D.D.S., Ph.D., an expert on quality of care, is president and medical director of South Shore Health Care in Braintree, Massachusetts, where he practices internal, oral, and occupational medicine. He serves on the medical faculties of Boston University and Tufts University and is used as a consultant by many regulatory and law enforcement agencies.
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1179536 01/28/12 C Y
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CONSUMER HEALTH A Guide to Intelligent
Decisions
STEpHEN BARRETT, MD Author, Editor, Consumer Advocate Webmaster, Quackwatch Network
Chapel Hill, North Carolina
WiLLiAM M. LONDON, EDD, MpH Professor, Department of Public Health
California State University Los Angeles, California
MANfRED KROgER, pHD Professor Emeritus of Food Science
Professor Emeritus of Science, Technology and Society The Pennsylvania State University
University Park, Pennsylvania
HARRiET HALL, MD Retired Family Physician
Puyallup, Washington
ROBERT S. BARATz, MD, DDS, pHD President and Medical Director, South Shore Health Care
Braintree, Massachusetts
Ninth Edition
CONSUMER HEALTH: A gUiDE TO iNTELLigENT DECiSiONS, NiNTH EDiTiON
Published by McGraw-Hill, a business unit of The McGraw-Hill Companies, Inc., 1221 Avenue of the Americas, New York, NY 10020. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved. Previous editions © 2007, 2002, 1997. Printed in the United States of America. No part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written consent of The McGraw-Hill Companies, Inc., including, but not limited to, in any network or other electronic storage or transmission, or broadcast for distance learning.
Some ancillaries, including electronic and print components, may not be available to customers outside the United States.
RECYCLED
This book is printed on recycled, acid-free paper containing 10% postconsumer waste.
1 2 3 4 5 6 7 8 9 0 QDB/QDB 1 0 9 8 7 6 5 4 3 2
ISBN 978-0-07-802848-9 MHID 0-07-802848-5
Vice President & Editor-in-Chief: Michael Ryan Vice President & Director of Specialized Publishing: Janice M. Roerig-Blong Publisher: David Patterson Executive Editor: Christopher Johnson Marketing Coordinator: Colleen P. Havens Development Editor: Darlene Schueller Senior Project Manager: Lisa Bruflodt Cover Designer: Studio Montage, St. Louis, Missouri Design Coordinator: Brenda A. Rowles Buyer: Sue Culbertson Media Project Manager: Sridevi Palani Primary Typeface:11-point Times Composition: Stephen Barrett, M.D. Printer: Quad/Graphics
All credits appearing on page or at the end of the book are considered to be an extension of the copyright page.
Library of Congress Cataloging-in-Publication Data
Consumer health : a guide to intelligent decisions / Stephen Barrett ...[et al.]. — 9th ed. p. cm. Includes bibliographical references and index. ISBN 978-0-07-802848-9 (alk. paper) 1. Medical care. 2. Health products. 3. Quacks and quackery. 4. Consumer education. I. Barrett, Stephen, 1933- RA410.5.C645 2013 362.1--dc23 2011039127
www.mhhe.com
Stephen Barrett, M.D., a retired psychiatrist who resides near Chapel Hill, North Carolina, has
achieved national renown as an author, editor, and con- sumer advocate. In addition to heading Quackwatch, he is vice president of the Institute for Scientific Medicine and a Fellow of the Committee for Skeptical Inquiry (formerly called CSICOP). In 1984, he received an FDA Commissioner’s Special Citation Award for Public Service in fighting nutrition quackery. In 1986, he was awarded honorary membership in the American Dietetic Association. From 1987 through 1989, he taught health education at The Pennsylvania State University. In 2001 he received the Distinguished Service to Health Educa- tion Award from the American Association for Health Education. He has been listed in Who’s Who in America since 2001 and is also listed in Who’s Who in Science and Engineering, Who’s Who in Medicine and Health Care, and Who’s Who in the World. An expert in medical communications, Dr. Barrett operates 25 Web sites; edits Consumer Health Digest (a free weekly electronic newsletter); is medical editor of Prometheus Books; and is a peer-review panelist for several top medical journals. His 51 books include The Health Robbers: A Close Look at Quackery in America and seven of the previous editions of Consumer Health. His other major works include Dubious Cancer Treat- ment, published by the Florida Division of the American Cancer Society; Health Schemes, Scams, and Frauds, published by Consumer Reports Books; The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods, published by Prometheus Books; and Reader’s Guide to “Alternative” Health Methods, published by the American Medical Associa- tion. His Quackwatch Web site, which serves as a clear- inghouse for information on health frauds and quackery, has won more than 70 honors and awards. Since moving to North Carolina in 2007, he has been swimming com- petitively and has won 25 state championship events.
William M. London, Ed.D., M.P.H., is a professor in the Honors College and the Department of Public
Health at California State University, Los Angeles. He
is also associate editor of Consumer Health Digest, co-host of the Credential Watch Web site, a consultant to the Committee for Skeptical Inquiry, a Quackwatch advisor, an advisor to the American Council on Science and Health (ACSH), a founding fellow of the Institute of Science in Medicine, a member of the review board of the American Journal of Health Behavior, and a member of the International Editorial Board of the journal FACT (Focus on Alternative and Complementary Therapies: An Evidence-Based Approach). He was an associate professor and chair of the Department of General Studies at Charles Drew University of Medicine and Science, where he led the initiation of the Master’s Program in Urban Public Health. He has also been an associate professor of health education at Kent State University; founding president of the Ohio Council Against Health Fraud; president of the National Council Against Health Fraud; faculty mentor in public health at Walden Univer- sity; professor of Health Sciences at Touro University International; associate professor and director of the Graduate Program in Health Care Management at Col- lege of St. Elizabeth; director of public health for ACSH; director of communications at Columbia University’s Mailman School of Public Health; and executive direc- tor of RAP, Inc., a nonprofit mental health and senior citizens service agency in Genesee County, New York.
Manfred Kroger, Ph.D., is Professor Emeritus of Food Science and Professor Emeritus of Sci-
ence, Technology and Society at The Pennsylvania State University, where he has won several teaching awards. He is a science communicator for the Institute of Food Technologists and is scientific editor of its online journal, Comprehensive Reviews in Food Science and Food Safety. He also serves as associate editor of the Journal of Food Science, an ACSH scientific advisor, and a technical editor for Prometheus Books. He has conducted research in analytical chemistry (pesticide residues), food composition, fermented milk products, and dairy processing technology. Even though retired, he remains professionally active at Penn State and nation- ally and internationally. His university courses included
About the Authors
iii
food laws and regulations, toxicology, introductory food science, dairy technology, and a very popular university- wide general education course entitled “Food Facts and Fads.” His other professional activities include lecturing at public and professional meetings, expert testimony in court and at government hearings, and translation of German writings. In 1999 he was elected as a Fellow of the Institute of Food Technologists. In 2003, he served as the editor of the Proceedings of the 12th World Congress of Food Science and Technology.
Harriet Hall, M.D., is a retired family physician who resides in Puyallup, Washington. She served for 20
years in the U.S. Air Force, from which she retired in 1989 as a full colonel. In addition to practicing family medicine and flight medicine, she held administrative positions including Chief of Aerospace Medicine and Director of Base Medical Services. Since retiring, Dr. Hall has devoted her time to investigating questionable health claims and writing and lecturing about pseudo- science, quackery, “alternative medicine,” and critical thinking. She is a contributing editor to both Skeptical Inquirer and Skeptic magazines and writes the latter’s “SkepDoc” column. She is also a founding member and editor of the Science-Based Medicine blog; an advisor to the Quackwatch network; an editorial review board member for the Natural Medicines Comprehensive Da- tabase; a Fellow of the Committee for Skeptical Inquiry; and a founding fellow and board member emerita of the Institute for Science in Medicine. Her 2008 book, Women Aren’t Supposed to Fly: The Memoirs of a Female Flight Surgeon, describes how she became a pilot and helped bring about equality for women physicians in the Air Force. Her Web site is www.skepdoc.info.
Robert S. Baratz, M.D., D.D.S., Ph.D.,who contrib- uted mainly to the medical and dental chapters of
this book, is an internist, dentist, and researcher who resides in Newton, Massachusetts. The founder of four companies, he has also served as medical director for two others in the medical device and pharmaceutical industries. He has been involved with issues regarding the safety and proper use of drugs and biomaterials since 1980. He has served on the medical and dental faculties of Northwestern and Tufts universities. Currently he serves on the faculty of Boston University School of Medicine, having initially been appointed in 1976. His broad knowledge of interactions of materials and the body has been sought by numerous licensing boards, regulatory agencies, universities, government agencies, insurance companies, and professional associations. He is also an expert in medical database applications and analyses. Dr. Baratz has worked for more than 25 years in dental and medical practice for private, public, and government entities, including the Department of Veterans Affairs, The Daughters of Charity, and Beth Israel Hospital in Boston. He has also worked for the Agency for International Development. Currently he is President and Medical Director of South Shore Health Care in Braintree, Massachusetts, where he practices internal and occupational medicine. He has also served as NCAHF President; a scientific advisor to ACSH; and President of International Medical Consultation Services, Inc., of Newton, Massachusetts. In 1992, the American Dental Association gave him a Presidential Citation for his work in advancing oral public health. He has been listed in Who’s Who in America, Who’s Who in the World, and Who’s Who in Science and Engineering.
About the Authorsiv
More is known today about achieving and maintain- ing good health than ever before. Life expectancy
is at an all-time high, and although there is still much room for improvement, health-related accomplishments have exceeded the fondest dreams of past visionaries. This progress has been partly due to a safer environ- ment that includes cleaner water, safer food, and better living space. Yet we hear plenty of news about the en- vironment that concerns us. Preventive and therapeutic medical care have advanced tremendously, yet we worry about the risks associated with immunization, cancer therapies, prescription drugs, surgery, and many other methods of treatment. How can we resolve our concerns and reap the benefits of modern scientific discoveries? The key is to become well-informed. The challenges involved are enormous. The health marketplace—the world of commercial activity for health-related products and services—is complex and dynamic. The Internet offers vast amounts of informa- tion, but much of it is not trustworthy. Health concerns can be overwhelming, especially for people confronted with medical crises. Quackery is more pervasive and far trickier than most people realize. (As noted by the late James Harvey Young, Ph.D., “Quacks never sleep.”) Health-care costs continue to rise despite numerous reform efforts. The rapidly growing older adult popula- tion faces a bewildering array of choices and obstacles for obtaining and paying for appropriate health care. It can also be difficult to determine what health care actu- ally costs and to obtain the best prices. In addition, many people lack access to adequate health care because of cultural, transportation, language, and economic barriers. Government and private agencies protect consumer rights in some ways but not others. The health-care industry is accountable to consumers to some extent, but quality is often elusive and abuses persist. Some scams are even facilitated by legislation and government policies. Consumer advocacy calls for justice and fair play in the marketplace. Yet many self-appointed “consumer advocates” do not act in the public’s interest. Although some are sincere and make a contribution, others engage in irrational business bashing or act from motives of per- sonal aggrandizement. Some business trade associations even pose as “consumer groups” and seek self-serving legislation.
Consumer Health offers a panoramic view of the health marketplace. It explains and supports the scientific methods that are essential for validating claims about how products and services affect health. It can help you to: • Understand how medical facts are determined and where
to get appropriate information and advice • Avoid wasting money on unnecessary, ineffective, or unsafe
products and services • Take care of yourself and minimize your need to spend
money on health products and services • Choose appropriate health products and services to meet
your needs • Get the most value out of your health dollars • Optimize benefits from encounters with health-care provid-
ers and facilities while minimizing the potential for harm • Assert and protect your rights • Set reasonable expectations for what health care can do • Evaluate how political issues affect access to health-related
innovations and accountability of marketers
The key to intelligent decision-making is to use relevant and accurate sources of information. Consumer Health is both an introductory text and a reference book on the opportunities and pitfalls of the health market- place. The various chapters offer hundreds of practical tips; the Appendix provides a comprehensive list of trustworthy sources. You will get the most out of the book by using the detailed Index to search for information and the Glossary for definitions of terms that might be unfamiliar. We also operate many Web sites that can supplement your coursework. Consumer Health Sourcebook (www. chsourcebook.com) provides hyperlinks to dependable online sources. It also links to Consumer Health Digest, a free weekly e-mail report of relevant news. Internet Health Pilot (www.ihealthpilot.org) is a gateway to ad- ditional trustworthy information. Quackwatch (www. quackwatch.org) and its many subsidiary sites provide comprehensive articles about quackery, health fraud, and consumer health strategy. All of these sites are accessible free of charge. Visiting them is a good way to enhance your learning experience.
Stephen Barrett, M.D. William M. London, Ed.D, M.P.H. Manfred Kroger, Ph.D. Harriet Hall, M.D. Robert S. Baratz, M.D., D.D.S., Ph.D.
To the Reader
v
Preface for Instructors
vi
As have previous editions, this ninth edition of Consumer Health emphasizes the opportunities
and pitfalls in the health marketplace and aims to help students protect their health and their pocketbook.
Goal for This Revision The book’s fundamental purpose is to provide trustwor- thy information and guidelines to enable people to select health products and services intelligently. This edition culminates our review of thousands of books, journal articles, Web sites, agency reports, and feature stories, as well as our own original investigations and critiques. Readers will find the information useful in applying the caveat emptor (let the buyer beware) concept to the health marketplace. The underlying principles of consumer protection were identified in the Consumer Bill of Rights promul- gated by President John F. Kennedy and have guided the development of this textbook. President Kennedy declared that consumers have the right to purchase safe products and services, to be correctly informed, to freely choose products and services, and to be heard by the government and others when injustices occur. We strongly support consumer awareness and efforts to as- sert and protect these rights.
Intended Audience Consumer Health has been designed as a sole required textbook for consumer health courses. Selected chapters of the book (see “Publisher’s Notice” box) can also be useful as required or supplemental readings for other courses in health education; community health; public health; family and consumer sciences; consumer edu- cation; health psychology; medical sociology; human ecology; and social welfare. School districts will find Consumer Health useful as a reference for teachers and students as well as an aid in curriculum development. Professional health-care providers can use this text to prepare for public presentations and can make it avail- able in their offices for perusal by clients.
Timeliness of References Every topic in this book has been carefully researched. In most cases, the more than 1500 cited references
represent the latest authoritative information we could locate. Many more systematic reviews and meta-analyses have been cited in this edition than in previous editions. Some references may seem outdated. However, unless otherwise stated, we believe these still reflect the cur- rent marketplace. References more than 10 years old are included for historical reasons or because they provide insights or document the source of well-articulated quo- tations that are still timely. Some reports published long ago are the only ones available that address important concepts. Chapter 1 provides information on how to read cita- tions and locate the references cited in the text. Those that
Publisher’s Notice
McGraw-Hill Create™ Craft your teaching resources to match the way you teach! With McGraw-Hill Create, you can easily rear- range chapters, combine material from other content sources, and quickly upload content you have writ- ten like your course syllabus or teaching notes. Find the content you need in Create by searching through thousands of leading McGraw-Hill textbooks. Arrange your book to fit your teaching style. Create even allows you to personalize your book’s appearance by selecting the cover and adding your name, school, and course information. Order a Create book and you’ll receive a complimentary print review copy in 3–5 business days or a complimentary electronic review copy (eComp) via e-mail in minutes. Go to www.mcgrawhillcreate. com today and register to experience how McGraw-Hill Create empowers you to teach your students your way.
Electronic Textbook Option This text is offered through CourseSmart for both in- structors and students. CourseSmart is an online resource where students can purchase the complete text online at almost half the cost of a traditional text. Purchasing the eTextbook allows students to take advantage of CourseSmart’s Web tools for learning, which include full text search, notes and highlighting, and e-mail tools for sharing notes between classmates. To learn more about CourseSmart options, contact your sales representative or visit www.CourseSmart.com.
Preface for Instructors vii
may be especially useful for students seeking additional information are listed with boldface numbers. When citing material on Web sites, we report the publication date when the site identifies it. When no date is posted, we report when we last accessed the page.
Internet Integration Another important feature of this edition is its integra- tion with our Consumer Health Sourcebook Web site (www.chsourcebook.com). The “References” section of this site provides links to many full-text articles and to abstracts of most of the journal articles. Suggestions for course objectives, teaching/learning activities, a sample course outline, and links to hundreds of organizations that provide trustworthy information are also posted. We encourage students and instructors to subscribe to Consumer Health Digest, a free weekly e-mail news- letter edited by Dr. Barrett with help from Dr. London. (To subscribe, see www.ncahf.org/digest/chd.html.) At the publisher’s Web site (www.mhhe.com/bar- rett9e), instructors will find sample test questions and PowerPoint presentations to use with the book.
Organization As in the eighth edition, the text is broadly divided into six parts: I. Dynamics of the Health Marketplace focuses on past and present problems. After defining the major consumer health issues, it discusses how the scientific method is used to determine medical truths, how con- sumers can separate fact from fiction, how frauds and quackery can be identified, and how advertising and other marketing activities influence consumer decisions. II. Health-Care Approaches covers basic medical care and the services of many types of practitioners and facilities. III. Nutrition and Fitness integrates what consum- ers need to know about the extremely important topics of nutrition, weight control, and exercise. Its chapters provide the necessary tools to distinguish science-based methods from fads, fallacies, and scams. IV. Personal Health Concerns provides a guide to preventing and managing health problems, including several in which self-care is very important. Separate chapters cover cardiovascular disease and cancer with an emphasis on the choices consumers face. V. Other Products and Services covers a myriad of other subjects that affect most, if not all, consumers. These include drug products, skin care and image en- hancement, contraceptive methods, vision and hearing
aids, other devices, death-related services, and health- care facilities. VI. Protection of the Consumer focuses on legal and economic issues involved in protecting consumers. These include health insurance, health-care financing, consumer-protection laws and agencies, and strategies for intelligent consumers.
Features and New Material All features from the eighth edition have been retained. Many chapters contain vignettes (“Personal Glimpses”) to stimulate reader interest and “Consumer Tip” and “Consumer Insight” boxes that emphasize key points. Many checklists and “It’s Your Decision” boxes reflect “real-life” decisions that readers may face. The “Key Concepts” box at the beginning of each chapter states what we believe are the most important lessons to be learned from the chapter material. Extensive searches of the scientific literature, court documents, and other relevant reports over an 18-month period have provided information to update the contents of this edition.
• Chapter 1 (Consumer Health Issues) introduces the im- portant issues facing consumers in today’s marketplace. New material about cognitive bias explains how distortions of thinking can lead to inaccurate conclusions and faulty judgment.
• Chapter 2 (Separating Fact from Fiction) describes how the scientific community strives to determine what is factual and how consumers face an often bewildering array of information that can be unbalanced, inaccurate, and even fraudulent.
• Chapter 3 (Frauds and Quackery) explains why people are vulnerable and tells how to avoid quack practices. New material notes how loss of faith in many of our once-trusted institutions has made quack claims seem more credible.
• Chapter 4 (Advertising and Other Promotional Activities) describes how sellers market their wares and notes how the multilevel marketing industry thwarted a proposed Federal Trade Commission rule intended to curb its misleading practices.
• Chapter 5 (Science-Based Health Care) describes the training and professional activities of physicians and many ancillary providers. It also incorporates U.S. Preventive Services Task Force’s latest conclusions about screening tests, including its skepticism about routine PSA testing.
• Chapter 6 (Mental and Behavioral Help) provides a com- prehensive guide to mental help and notes that psychiatrists are shifting away from psychotherapy. The section on ques- tionable practices and practitioners has been expanded and cautions against the use of poorly trained “life coaches.”
• Chapter 7 (Dental Care) provides a comprehensive dental guide and warns against the increasing use of questionable
Preface for Instructorsviii
screening devices and expensive cosmetic dental proce- dures intended to create a “perfect bite.”
• Chapter 8 (The “CAM” Movement) describes a multitude of theories and practices that remain unsubstantiated and lack a scientifically plausible rationale. It also notes the failure of accrediting agencies to control the spread of unscientific teachings in professional schools (including medical schools).
• Chapter 9 (A Close Look at Chiropractic) spotlights the in- fluence of chiropractic on the consumer health marketplace and summarizes the latest research on spinal manipulation.
• Chapter 10 (Basic Nutrition Concepts) incorporates the latest Dietary Guidelines for Americans and the USDA Food Guidance System (Choose MyPlate) and tells where to get trustworthy nutrition information and advice.
• Chapter 11 (Nutrition Fads, Fallacies, and Scams) includes up-to-date evaluations of dietary supplement products and herbal products and background material on promoters of nutritional misinformation.
• Chapter 12 (Weight Control) notes the alarming increase of obesity in the United States and discusses appropriate and inappropriate weight-control measures.
• Chapter 13 (Fitness Concepts, Products, and Services) reviews the fundamental concepts typically addressed in personal health courses, but also includes important details about practitioners, information resources, products, ser- vices, popular misconceptions, and scams.
• Chapter 14 (Personal Health and Safety), which is a new chapter, focuses on health promotion, injury prevention, risk perception, self-care, and the management of asthma, diabetes, high blood pressure, and other chronic condi- tions. It also notes how information from the Internet and elsewhere can help or undermine prudent behavior. A new section warns against the widely circulating myths that undermine public health efforts.
• Chapter 15 (Cardiovascular Disease) contains new and updated information about risk factors for coronary heart disease and stroke and provides guidelines for reducing the risks.
• Chapter 16 (Cancer) covers cancer causation, prevention, diagnosis, and prognosis and contrasts science-based and dubious treatments. The new topics include vaccination against the human papilloma virus (HPV) and dubious information sources.
• Chapter 17 (Drug Products) includes new information about commonly used nonprescription (over-the-counter) drugs and how to save money on drug costs.
• Chapter 18 (Skin Care and Image Enhancement) covers a wide variety of topics related to skin care plus new material about image-enhancement schemes and frauds.
• Chapter 19 (Sexual and Reproductive Health) covers products and services related to sexual and reproductive functions. It includes new and updated information about birth control, birthing options, and hormone-replacement therapy, and prevention of sexually transmitted diseases.
• Chapter 20 (Health Devices) contains updated information about device regulation and expanded coverage of question- able devices that have been flooding the health marketplace. New topics include spinal decompression machines, “de- toxification” devices, and alleged performance enhancing bracelets.
• Chapter 21 (Coping with Death) provides current informa- tion on advance directives and organ donation and cautions about stem-cell clinics and “biologic age” testing.
• Chapter 22 (Health-Care Facilities) notes how the delivery of health-care services is changing and describes the salient features of various options. It also provides advice on how to choose among the various alternatives.
• Chapter 23 (Health Insurance) describes the basic types and features of health insurance and outlines the major provisions of the Patient Protection and Affordable Care Act.
• Chapter 24 (Health-Care Financing) provides the latest available statistics on national health expenditures, states why insurance reform has been desperately needed, and describes the decades-long struggle to control costs and increase access to medical care.
• Chapter 25 (Consumer Laws, Agencies, and Strategies) details the regulatory and educational activities of the U.S. Food and Drug Administration and the FTC; describes physician regulation; and indicates what consumers can do to help improve the health marketplace.
• The Appendix provides comprehensive lists of agencies and organizations that offer trustworthy information. The Consumer Health Sourcebook Web site links to most of them.
• The Glossary clarifies important jargon used in the book and defines other terms of interest to health consumers.
Acknowledgments The authors thank John E. Dodes, D.D.S., who reviewed the dental care chapter; Walter A. Zelman, Ph.D., of California State University (Los Angeles), who offered helpful suggestions for the chapters on insurance and health-care financing. The photograph on page 154 is reproduced with permission from Aurora & Quanta Productions, Portland, Maine. The VIPPS logo on page 358 appears with permission of the National Association of Boards of Pharmacy. Our project coordinator, who guided production and permitted this text to remain a powerful voice, was Vicki Malinee of Van Brien & Associates. Freelance editor Sarah West, of Belleville, Illinois, did her usual superb job of copy editing. We also thank the many instructors who continue to provide suggestions for new research and topics to include in the text.
i. DyNAMiCS Of THE HEALTH MARKETpLACE
1. Consumer Health Issues, 1 Misleading Information, 2 Quackery and Health Fraud, 5 Problems with Products, 6 Problems with Services, 7 Problems with Costs and Access, 8 Problems with Risk Perception, 8 The Need for Consumer Protection, 8 Intelligent Consumer Behavior, 10
2. Separating Fact from Fiction, 13 How Facts Are Determined, 14 Peer Review, 17 Trustworthiness of Sources, 19 Prudent Use of the Internet, 27 Further Suggestions for Consumers, 30
3. Frauds and Quackery, 33 Definitions, 34 Scope, 35 Vulnerability, 36 Hazards, 37 Common Misconceptions, 38 Recognizing Quackery, 41 Conspiracy Claims, 42 The Freedom-of-Choice Issue, 43
4. Advertising and Other Promotional Activities, 45 Psychologic Manipulation, 46 Puffery, Weasel Words, and Half Truths, 48 Marketing Outlets, 49 Professional Advertising, 49 Marketing by Hospitals, 50 Prescription Drug Marketing, 51 Nonprescription Drug Advertising, 53 Tobacco Promotion, 53 Food Advertising, 54 Dietary Supplement Promotion, 54 Mail-Order Quackery, 57 Weight-Control Promotions, 59 Youth and Beauty Aids, 59
Exercise and Fitness Products, 60 Program-Length Infomercials, 60 Multilevel Marketing (MLM), 61 Telemarketing Schemes, 62 Industry Self-Regulation, 62 Regulatory Agencies, 63
ii. HEALTH-CARE AppROACHES
5. Science-Based Health Care, 65 Health-Care Personnel, 66 Choosing a Physician, 70 Basic Medical Care, 75 Surgical Care, 80 Quality of Medical Care, 82 The Intelligent Patient, 85
6. Mental and Behavioral Help, 89 Who Should Seek Help?, 90 Mental Health Practitioners, 90 Psychologic Methods, 93 Drug Therapy, 94 Electroconvulsive Therapy, 95 Psychosomatic Disorders, 96 Inpatient Care, 96 Help for Addictive Behavior, 96 Selecting a Therapist, 97 Questionable “Self-Help” Products, 98 Questionable Practices, 100 Mismanagement of Psychotherapy, 107
7. Dental Care, 111 Dentists, 112 Allied Dental Personnel, 112 Tooth Decay, 113 Fluoridation, 114 Periodontal Disease, 115 Self-Care, 116 Dental Products, 117 Dental Restorations, 119 Endodontics (Root Canal Therapy), 120 Orthodontics, 120 Dentures, 121 Dental Implants, 121
Contents
ix
Dental X-Ray Procedures, 121 Questionable Procedures, 122 Dental Quackery, 124 Choosing a Dentist, 126
8. The “CAM” Movement, 131 Classification, 132 Popularity, 134 Common Themes, 135 Homeopathy, 137 Acupuncture and TCM, 141 Naturopathy, 143 Natural Hygiene, 145 Iridology, 145 Reflexology, 146 Cranial Therapy, 147 Aromatherapy, 147 “Energy Healing,” 147 Massage Therapy, 148 Psychic Healing, 148 Astrology, 151 Transcendental Meditation, 152 Unscientific Medical Practices, 154 Supportive Organizations 158 “Medical Freedom” Laws, 158 The NIH Center for Complementary and Alternative Medicine (NCCAM), 158
9. A Close Look at Chiropractic, 163 Historical Perspective, 164 Chiropractic Philosophy, 165 Chiropractic Education, 168 Research Findings, 169 Problems for Consumers, 170
iii. NUTRiTiON AND fiTNESS
10. Basic Nutrition Concepts, 175 Major Food Components, 176 Meeting Nutrient Needs, 179 Food-Group Systems, 182 Evaluating Your Diet, 183 Guidelines for Infants and Toddlers, 183 Vegetarianism, 184 “Fast Food,” 186 Nutrients of Special Concern, 186 Nutrition Labeling, 187 Trustworthy Information Sources, 191
11. Nutrition Fads, Fallacies, and Scams, 195 Food Faddism and Quackery, 196 Dietary Supplements, 197 Megavitamin Claims vs Facts, 203 Appropriate Use of Supplements, 206 “Organic” Foods, 206 “Health” and “Natural” Foods, 207 Raw Foods and “Juicing,” 213 “Medicinal” Use of Herbal Products, 213 Macrobiotic Diets, 219 Dubious Diagnostic Tests, 219 Promotion of Questionable Nutrition, 221 Promotional Organizations, 227 Prominent Individual Promoters, 228
12. Weight Control, 233 Basic Concepts, 234 Eating Disorders, 238 The U.S. Weight-Loss Marketplace, 240 Questionable Diets, 240 Prescription Drugs, 243 Nonprescription Products, 244 Low-Calorie Products, 246 Bariatric Surgery, 248 Dubious Products and Procedures, 248 Federal Trade Commission Actions, 250 Weight-Control Organizations, 252 Suggestions for Weight Control, 254
13. Fitness Concepts, Products, and Services, 259 Public Perceptions, 260 Benefits of Exercise, 261 Types of Exercise, 262 Components of Fitness, 262 Starting an Exercise Program, 263 Personal Trainers, 269 Sports Medicine Specialists, 270 Exercise Equipment and Supplies, 270 Exercise Facilities, 276 Martial Arts Training, 278 Children’s Exercise Centers, 278 Exercise While Traveling, 278 Exercise and Weight Control, 279 Nutrition for Athletes, 279 Anabolic Steroids, 281 Other “Ergogenic Aids,” 282
Contentsx
iV. pERSONAL HEALTH CONCERNS
14. Personal Health and Safety, 287 Types (Levels) of Prevention, 288 Health-Promoting Behaviors, 288 Safety Measures, 291 Indoor Air Quality, 291 Risk Perception, 292 Self-Diagnosis, 292 Managing Chronic Disease, 295 Self-Help Advice, 300 Self-Help Groups, 301 Questionable Self-Help Devices, 301 Internet Considerations, 301
15. Cardiovascular Disease, 305 Significance of Cardiovascular Disease, 306 Risk Factors for Coronary Heart Disease, 306 Blood Lipid Levels, 307 Cholesterol Guidelines, 309 Dietary Modification, 311 Lipid-Lowering Drugs, 315 Preventive Use of Aspirin, 317 Questionable Preventive Measures, 318 High Blood Pressure, 320 Heart Attacks, 322 Diagnostic Tests, 322 Surgery to Restore Blood Flow, 324 Cardiac Rehabilitation Programs, 326
16. Cancer, 329 Avoidable Causes of Cancer, 330 Preventive Measures, 331 Diagnosis, 331 Prognosis, 332 Evidence-Based Treatment Methods, 332 Diet and Cancer Prevention, 333 Susceptibility to Cancer Quackery, 334 Questionable Methods, 335 Promotion of Questionable Methods, 344 Trustworthy Information Sources, 345 Treatment Guidelines, 345 Consumer Protection Laws, 346
V. OTHER pRODUCTS AND SERViCES
17. Drug Products, 349 Medication Types, 350
Pharmacists, 351 Prescription Drugs, 353 Generic vs Brand-Name Drugs, 354 Drug Interactions, 355 Drug Recalls, 355 Counterfeit Drugs, 355 Internet Pharmacy Sales, 358 Over-the-Counter Drugs, 359 External Analgesics, 360 Internal Analgesics, 361 Antacids and Other Heartburn Remedies, 364 Antimicrobial Drug Products, 364 Cough and Cold Remedies, 365 Sore-Throat Products, 367 Ophthalmic Products, 367 Diarrhea Remedies, 368 Anti-Hemorrhoidals, 368 Laxatives, 369 Smoking Deterrents, 370 Stimulants for Fatigue, 371 Sleep Aids, 371 Motion Sickness Remedies, 372 Iron-Containing Products, 372 Home Medicine Cabinet, 373 Prudent Use of Medication, 373
18. Skin Care and Image Enhancement, 379 Cosmetic Regulation, 380 Soaps and Cleansers, 381 Moisturizers, 381 Questionable Claims, 382 Wrinkles and Age Spots, 383 Fade Creams, 384 Antiperspirants and Deodorants, 384 Acne Care, 384 Head Hair and Scalp Care, 386 Hair Loss, 388 Tattoos and Permanent Makeup, 389 Body Piercing, 390 Treatment of Common Foot Problems, 390 Poison Ivy, 390 Insect Repellents, 391 Sun Protection, 391 Camouflage Cosmetics, 393 Cosmetic Procedures, 393 Bogus Breast and Penis Enlargement Claims, 398
Contents xi
19. Sexual and Reproductive Health, 401 Menstrual Products, 402 Menstrual Problems, 403 Vaginal Hygiene, 404 Vaginitis, 405 “Jock Itch,” 405 Sexually Transmitted Diseases, 405 Contraception, 406 Voluntary Abortions, 410 Infertility, 411 Genetic Testing and Prenatal Counseling, 411 Pregnancy and Delivery, 411 Cord Blood Banking, 414 Infant Feeding, 414 Treatment of Menopausal Symptoms, 415 Alleged Sex Enhancers, 416 Genuine Help for Erectile Dysfunction, 416
20. Health Devices, 419 Medical-Device Regulation, 420 Vision Products and Services, 421 Hearing Aids, 427 Humidifiers and Vaporizers, 429 Personal Emergency Response Systems, 430 Latex Allergy, 430 Dubious Water Purifier Promotions, 430 Spinal Decompression Machines, 431 Quack Devices, 431 Consumer Strategy, 435
21. Coping with Death, 437 Advance Directives, 438 Viatical Settlements, 441 Donations of Organs and Tissues, 442 Hospice Care, 443 Euthanasia and Assisted Suicide, 444 Reasons for an Autopsy, 445 Body Disposition, 445 Coping with Grief, 448 Life-Extension/Anti-Aging Quackery, 448
22. Health-Care Facilities, 453 Accreditation, 454 Outpatient Medical Facilities, 454 Hospitals, 457 Home Care Services, 460
Contents
Assisted Living Facilities, 461 Nursing Homes, 461 Continuing Care Retirement Communities, 464
Vi. pROTECTiON Of THE CONSUMER
23. Health Insurance, 467 Background, 468 Comprehensive Medical Insurance, 468 Contract Provisions, 471 Types of Plans, 474 Consumer-Directed Expense Accounts, 476 “Concierge Medicine,” 476 Indemnity vs Managed Care, 477 Loss Ratios, 478 Choosing a Plan, 478 Medicare, 480 Medicaid, 481 Other Government-Sponsored Programs, 481 Long-Term–Care Insurance, 481 Dental Insurance, 482 Collection of Insurance Benefits, 483 Disability Insurance, 484
24. Health-Care Financing, 487 Health-Care Costs, 488 Cost-Control Methods, 492 Insurance Fraud and Abuse, 494 National Health Insurance (NHI), 498
25. Consumer Laws, Agencies, and Strategies, 503 U.S. Food and Drug Administration, 504 Federal Trade Commission, 515 U.S. Postal Service, 517 Other Federal Agencies, 517 State and Local Agencies, 518 Physician Regulation, 518 Nongovernmental Organizations, 519 Consumer Action, 522
Appendix: Trustworthy Sources of Information, 525 Federal Government Agencies, 526 Nongovernmental Organizations, 526
Glossary, 529
Index, 541
xii
Consumer HealtH Issues
Consumer health goes far beyond the decision to buy or not to buy. The ever increasing perplexity of the health care delivery system; the prevalence of myths and misconceptions about health, disease, and remediation; the widespread usage of unproven health products and services; and the rapidly escalating costs of health care have ushered in the need to educate individuals in the proficient, judicious and eco- nomical utilization of health information, products, and services. Niles l. KaplaN1
Evidence clearly demonstrates that people are susceptible to error even when choosing among a handful of alternatives to which they can devote their full attention.
Barry schwartz2
Chapter One
Reprinted with special permission from King Features Syndicate
Part One Chapter One
Part One Dynamics of the Health Marketplace2
• To get the most out of our health-care system, consumers must be knowledgeable and appropriately assertive.
• Virtually all legitimate health products and services have bogus counterparts.
• Intelligent consumers maintain an appropriate level of skepticism and recognize their susceptibility to perceptual distortions and cognitive biases.
• Consumer protection agencies are unable to deal with many of the complaints they receive.
• Everyone in a free society has a stake in maintaining high standards in the health marketplace.
Keep tHese poInts In mInd as You studY tHIs CHapter
Key Concepts
Consumer health encompasses all aspects of the marketplace related to the purchase of health products and services. It includes such things as
buying a bottle of vitamins, a cold remedy, a dentifrice, or exercise equipment and selecting a physician, dentist, insurance policy, book, Web site, or other source of information. Consumer health has both positive and negative as- pects. Positively, it involves the facts and understanding that enable people to make medically and economically sound choices. Negatively, it means avoiding unwise decisions based on deception, misinformation, or other factors. Worksheet 1-1 provides an opportunity to test your knowledge of consumer health issues.
1. Everyone should have a complete physical examination every year or two. 2. Fluoride toothpaste works so well that water fluoridation is no longer important. 3. It is difficult for busy people to eat a balanced diet. 4. People intelligent enough to graduate from college are unlikely to be victimized by quackery. 5. Accreditation of a school indicates that a regulatory agency considers its teachings sound. 6. Cigarette smoking is the leading cause of preventable death in the United States. 7. Sugar is a major cause of hyperactivity and other childhood behavioral problems. 8. In most states no special training is legally required to offer counseling to the public. 9. Antioxidant supplements have been proven to protect against heart disease, stroke, and cancer. 10. Homeopathic remedies are a safe and effective alternative to many drugs that doctors prescribe. 11. Taking large daily doses of vitamin C can cut the risk of catching colds in half. 12. All people age 21 or older should have their blood cholesterol levels checked once a year. 13. Administering more than one vaccine at a time can overload the immune system. 14. The American Medical Association can revoke the license of a doctor who is practicing improperly. 15. Government reports indicate that the best person to consult for back pain is a chiropractor. 16. Most retailers of dietary supplements and herbal products are well informed about the products they sell. 17. Protein or amino acid supplements help bodybuilders and other athletes improve their performance. 18. The emergency department of a nonprofit hospital is a relatively inexpensive place to get medical care. 19. Natural cancer cures are being suppressed because drug companies don’t want competition. 20. Most health-related books and magazine articles are vetted by experts prior to publication. 21. Government agencies screen many ads for mail-order health products before they are published.
test Your Consumer HealtH I.Q. Worksheet 1–1
T F T F T F T F T F T F T F T F T F T F T F T F T F T F T F T F T F T F T F T F T F
Only #6 and #8 are true. Fifteen correct answers suggests that you are fairly well informed. Twenty correct suggests that you are very well informed.
This chapter comments on misleading information; quackery; health frauds; and problems with health-care products, services, costs, and access. It also outlines the strengths and weaknesses of consumer-protection forces, how consumers make health-related decisions, and the characteristics of intelligent consumers.
mIsleadIng InformatIon
Health information has become increasingly voluminous and complex. Even well-trained health professionals can have difficulty sorting out what is accurate and signifi- cant from what is not. Table 1-1 lists questions faced by many of today’s consumers.
Chapter One Consumer Health Issues 3
How can the significance of research reports be judged? How trustworthy are the media? How can trustworthy information sources be located?
What are the best ways to keep up-to-date on consumer health issues?
How can quacks and quackery be spotted? What should be done after encountering quackery or health fraud?
Is it sensible to try just about anything for health problems?
How should advertisements for health products and services be analyzed?
How should physicians, dentists, and other health-care specialists be selected?
What should be done about excessive or unreasonable professional fees?
When is it appropriate to obtain a second opinion about recommended surgery?
What periodic health examinations are advisable? How much should they cost?
Where can competent mental help be obtained? What kinds of toothbrushes and dentifrices are best? Can mouthwashes and dentifrices control the develop- ment of plaque on teeth?
When are dental implants appropriate? Do amalgam fillings pose any health hazard? What rights should buyers and sellers have in the health marketplace?
How trustworthy are chiropractors, naturopaths, and acupuncturists?
Is it advisable for people with back pain to see a chiropractor?
What is the best schedule for vaccinations? Is vaccination with Gardasil prudent? When are self-diagnosis and treatment appropriate? How should a hospital, nursing home, or convalescent facility be selected?
What are the pros and cons of using an ambulatory health-care center?
What facilities are available for people who need long- term care?
How can a balanced diet be selected? Does vegetarian eating make sense? When is it appropriate to use vitamin or mineral supplements?
Do antioxidant supplements prevent future diseases? Should “organic foods” or “health foods” be purchased? Are they worth their extra cost?
Can taking vitamin C supplements prevent or cure colds?
Should extra vitamins be taken during pregnancy?
Will taking calcium supplements help prevent osteoporosis?
Are any herbal products worth taking? How trustworthy is the advice given in health-food stores?
Are food additives dangerous? What is the safe way to lose and control weight? Are diet pills helpful or harmful?
Are electric vibrators and massage equipment useful for weight control or body shaping?
Which exercise equipment provides good value for its cost?
Is it a good idea to join a health club or exercise center? What principles should guide the evaluation and man- agement of blood cholesterol levels?
Can magnetic devices enhance athletic performance? Can any food or dietary measures prevent or influence the course of arthritis or cancer?
Does it make sense to undergo detoxification? How do pain relievers compare? Should laxatives be used? By whom? Is it a good idea to use generic drugs? What products are useful for self-care and family care? What is the best strategy for protecting against sun exposure?
Can any product help to grow, restore, or remove hair? Can wrinkles be removed with any product or with plastic surgery?
What forms of birth control are safest and most effective?
Are over-the-counter pregnancy test kits reliable? Are any over-the-counter drug products effective for menstrual cramps?
What can women do about premenstrual syndrome (PMS)?
Does the patenting of a health device ensure its safety and effectiveness?
How do the different types of contact lenses compare? Who should determine the need for eyeglasses, contact lenses, or a hearing aid?
How safe and effective is surgery to improve vision? Does it make sense to prepay funeral expenses? What services are available for the terminally ill? Which health coverage provides the best protection? How can consumers reduce their health-care costs? How much money should be budgeted for health care? What agencies and organizations help protect consumers?
Which consumer groups are trustworthy? How can one register a complaint about a health prod- uct or service?
Consumer HealtH QuestIons
Table 1–1
Part One Dynamics of the Health Marketplace4
The media have tremendous influence. Thousands of radio and television stations broadcast health-related news, commentary, and talk shows. Thousands of maga- zines and newspapers carry health-related items, and thousands of health-related books and pamphlets are published each year. Thousands of books recommend unscientific health practices, as do countless Web sites, blogs, and other computerized information sources. Gunther3 has noted that the mass media have four main functions: to entertain, to inform, to carry adver- tisements, and to make money for their stockholders. In many cases what is transmitted depends on (a) how much it is expected to interest the target audience and (b) how advertisers may feel about it. Larkin,4 for example, has noted that many women’s magazines publish sensational claims and deliberately avoid information that might upset their advertisers. Fast-breaking news should be regarded cautiously. Many reports, though accurate, tell only part of the story.5 Unconfirmed research findings may turn out to
be insignificant. The simplest strategy for keeping up-to- date is to subscribe to trustworthy newsletters and other review sources that place new information in proper perspective (see Chapter 2). Advertising should also be regarded with caution (see Chapter 4). Many advertisers use puffery, “weasel words,” half-truths, imagery, or celebrity endorsements to misrepresent their products. Some marketers use scare tactics to promote their wares. Some attempt to exploit common hopes, fears, and feelings of inadequacy. Cigarette ads have used images of youth, health, vigor, and social acceptance to convey the opposite of what cigarette smoking will do to smokers. Alcohol ads stress fun and sociability and say little about the dangers of excessive drinking. Many ads for cosmetics exaggerate what they can do (see Chapter 18). Food advertising, though not usually deceptive, tends to promote dietary imbalance by emphasizing snack foods that are high in fat and calories. Radio and television infomercials abound with promoters of health misinformation.
Physicians were once able to carry in their little black bags most of the tools needed to diagnose and treat pa- tients. They could store in their own minds the informa- tion necessary for the majority of their work. Experience broadened one’s ability to handle difficult or unusual cases, and patients relied upon their physicians as the pri- mary source of infor mation on both health and disease. The logarithmic increase in biomedical knowledge ... has changed the doctor -patient relationship dramatically. The history and physical examination, once the basis for all medical practice, are now only the first exploratory steps in the process of making a diagnosis and planning a treat ment regimen. The immense proliferation of labora- tory tests, imaging techniques, and diagnostic procedures is stunning. The specialties of medicine have further branched into subspecialties as basic research and clini- cal knowledge have greatly expanded. Medical journals and textbooks have multiplied in number, along with the arrival of new means of information delivery. No individual physician, no matter how capable or experienced, is able to absorb and memorize more than a small portion of this database. This is true despite the fact that convenient access to the information is developing rapidly. One can search the literature rapidly with the National Library of Medicine’s MEDLINE service to discover the latest in diag nosis, treatment, and outcome for any disease, common or rare.
Personal Glimpse
With the rapid growth and popularization of the Internet, access to the universe of medical information has been fundamen tally altered. Physicians and the public may draw on the resources of medical discussion groups and refer ence databases with unprecedented ease. But a new dilemma comes with this wonderful ad- vance. For decades, inquisitive patients have turned to health letters and magazines to supplement the informa- tion gained from consultation with their physician. These publications filled a gap in doctor-patient communication. As demands on the physician’s time have multiplied, the explanations offered to patients are too often cursory and incomplete. As the concept of individual responsibility for health has grown, the computerized medical database has broadened the patient’s horizons.. . . It is too early to analyze the virtues and problems of the information revolution. But some are obvious. For example, a World Wide Web query for the keyword “health” found . . . documents, ranging from commercial health products and alternative therapies to issues of sexuality, obesity, aging, and environmental health. . . . Since even physicians can have difficulty sorting out the truth in cyberspace, imagine the problem for the average person browsing the Internet.
Michael Kashgarian, M.D.6
Doctors and Patients in Cyberspace
Chapter One Consumer Health Issues 5
Although many authoritative publications are avail- able, greater numbers of books, magazines, newsletters, and Web sites promote false ideas. Chapter 2 discusses this problem in detail and provides guidance on choosing trustworthy sources.
QuaCKerY and HealtH fraud
Quackery is definable as the promotion of a false or unproven health method for profit (see Chapter 3). Fraud involves deceit. Despite tremendous progress in medical science and health education, Americans waste billions of dollars each year on products and services that are unsubstantiated or bogus. Dr. William Jarvis7
calls quackery “a national scandal.” Barrett and Herbert8 have noted:
People generally like to feel that they are in control of their life. Quacks take advantage of this fact by giving their clients things to do—such as taking vitamin pills, preparing special foods, meditating, and the like. The activity may provide a temporary psychological lift, but believing in false things can have serious consequences. The loss may be financial, psychological (when disillusionment sets in), physical (when the method is harmful or the person abandons effective care), or social (diversion from more constructive activities). . . . Quacks portray themselves as innovators and suggest that their critics are rigid, elitist, biased, and closed to new ideas. Actually, they have things backwards. The real issue is whether a method works. Science provides ways to judge and discard unfounded ideas. Medical science progresses as new methods replace less effective ones. Quack methods persist as long as they remain marketable.
Quackery promoters are adept at using slogans and buzzwords. During the 1970s their magic sales word was “natural.” During the 1980s the word “holistic” was popularized. Today’s leading buzzwords are “alterna- tive” and “complementary.” These terms are misleading because methods that do not work are not reasonable alternatives to proven treatment and combining them with standard methods increases cost but not effective- ness. This textbook places the words “alternative” and “complementary” in quotation marks when referring to unsubstantiated methods that lack a scientifically plau- sible rationale. Chapter 8 discusses them in detail. Although most people think of themselves as hard to fool, the majority of Americans are victims of quackery. Contrary to popular beliefs, for example: (a) most people who take vitamin supplements don’t need them; (b) vita- mins do not make people more energetic, more muscular, or less stressed; (c) “organically grown” foods are neither safer nor more nutritious than conventionally produced
foods; and (d) no nonprescription pill can produce rapid or permanent weight loss. Chapters 3, 11, and 12 cover these subjects thoroughly. Victims of quackery usually have one or more of the following vulnerabilities:
lacK of suspicioN: Many people believe that if something is printed or broadcast, it must be true or somehow its publica- tion would not be allowed. People also tend to believe what others tell them about personal experience.
desperatioN: Many people faced with a serious health problem that doctors cannot solve become desperate enough to try almost anything that arouses hope. Many victims of can- cer, arthritis, multiple sclerosis, and AIDS are vulnerable in this way.
alieNatioN: Some people feel deeply antagonistic toward scientific medicine but are attracted to methods that are “natural” or otherwise unconventional. They may also harbor extreme distrust of the medical profession, the food industry, drug companies, and government agencies.
Belief iN magic: Some people are easily taken in by the promise of an easy solution to their problem. Those who buy one fad diet book after another fall into this category.
False Beliefs Can Kill The danger of denying that the human immunodefi- ciency virus (HIV) is the causal agent of AIDS was spotlighted in 2005 by the sudden death of 3-year-old Eliza Jane Scovill of Van Nuys, California, during a bout of AIDS-related pneumonia. Eliza’s mother, Christine Maggiore, was HIV-positive. Medical man- agement of infected pregnant women had reduced the reported incidence of HIV/AIDS in children under age 13 from 952 in 1992 to only 59 in 2003. But Maggiore refused treatment for herself and did nothing to prevent transmission of the virus to her daughter. In fact, dur- ing her pregnancy, she even appeared on the cover of Mothering Magazine with the word AZT in a circle with the slash through it and the headline “HIV+ Moms Say NO to AIDS Drugs.” (AZT is an anti-AIDS drug.) Maggiore ran Alive & Well AIDS Alternatives, a nonprofit organization which falsely proclaimed that (a) most of the AIDS information the public receives was based on unsubstantiated assumptions, unfounded estimates, and improbable predictions and (b) the symptoms associated with AIDS were treatable with “non-toxic, immune enhancing therapies.” Maggiore herself died in 2008. Although an autopsy was not obtained, knowledgeable observers believe that she died of AIDS-related pneumonia.9
Personal Glimpse
Part One Dynamics of the Health Marketplace6
overcoNfideNce: Despite P.T. Barnum’s advice that one should “never try to beat a man at his own game,” some strong-willed people believe they are better equipped than scientific researchers and other experts to tell whether a method works.
problems wItH produCts
In light of scientific and technologic advances, it is not surprising that many people believe that health is pur- chasable. The health marketplace abounds with products of every description to accommodate people’s desires. The problem areas include dietary supplements; herbal and homeopathic products; exercise devices; diet pills and potions; self-help books, recordings, and gadgets; youth and beauty aids; magnets; and some types of over- the-counter drug products. Thousands of “supplement” products are marketed with false claims that they can boost energy, relieve stress, enhance athletic performance, and prevent or treat numerous health problems (see Chapter 11). Ads for “ergogenic aids” feature champion bodybuilders or other athletes without indicating that the real reason for their success is vigorous training. Few supplement
products have any usefulness against disease, and most that do—such as niacin for cholesterol control—should not be taken without competent medical supervision. Although some herbs sold for medicinal purposes are useful, most are not, and some are dangerous (see Chapter 11). Because the U.S. Food and Drug Admin- istration (FDA) does not require standards of identity or dosage for herbal products, consumers may be unable to tell what the products contain or how to use them. Moreover, many of the conditions for which herbs are recommended are not suitable for self-treatment. The vast majority of mail-order health products are fakes (see Chapter 4). The common ones include weight-loss products (mostly diet pills), “hair restor- ers,” “wrinkle removers,” and alleged sex aids. Figure 1-1 illustrates the flamboyant claims found in ads for mail-order diet and “nerve” pills. Many worthless devices are claimed to “synchro- nize” brain waves, relieve pain, remove unwanted fat deposits, improve eyesight, relieve stress, detoxify the body, and ward off disease. Thousands of self- instructional products and programs are marketed with false claims that they can help people lose weight, stop
fIgure 1-1. Ads for dubious mail-order products. The diet pill ad was published in many magazines during the late 1970s. Although no product can “neutralize calories” or fulfill the other promises in this ad, countless “weight-loss” products have been advertised in this way. The “nerve tonic” ad is from a 1996 flyer from a company that specializes in herbal products. Some of its statements about body physiology are true, but most are not related to each other, and the overall message is pseudoscientific gibberish. No ingredients are identified, and no product can remedy the long list of problems listed in the ad. Promotions like these are still common today because regulatory agencies lack the resources to control them, many people are unsuspecting enough to buy them, and many magazine and newspaper publishers value ad revenues more than ethics.
Chapter One Consumer Health Issues 7
smoking, enhance athletic performance, quit drinking, think creatively, raise IQ, make friends, reduce pain, improve vision, restore hearing, cure acne, conquer fears, read faster, speak effectively, handle criticism, relieve depression, enlarge breasts, and do many other things (see Chapter 6). Magnets embedded in clothing, mat- tresses, or other products are falsely claimed to relieve pain, increase blood flow, boost immunity, and provide other health benefits (see Chapter 20). Multilevel companies market a wide variety of health-related products, almost all of which are either in- appropriate or overpriced (see Chapter 4). The products are sold by individual distributors who also attempt to recruit friends, neighbors, relatives, and others to do the same. Several million people are involved in multilevel marketing. Most over-the-counter drug products can be useful in self-care. However, many ads encourage pill-taking for insomnia, lack of energy, constipation, and other problems that may have better solutions. Homeopathic “remedies” are the only category of spurious products legally marketable as drugs. Figure 1-2 illustrates a product that does not contain any molecules of its alleged “active ingredient.” Exercise equipment varies greatly in quality, use- fulness, and price. Before investing in equipment, it is important to determine what it can do and whether it can meet one’s needs or will be too monotonous for regular use (see Chapter 13). Some devices are gimmicks that have little or no effect on fitness.
problems wItH servICes
Although health care in America is potentially the world’s best, many practitioners fall short of the ideal, some are completely unqualified, and many consumers have problems with access and affordability. Many physicians prescribe too many drugs, order too many tests, fail to keep up-to-date, or pay insuf- ficient attention to preventive measures. Some do not spend sufficient time interviewing, examining, or advising their patients. Unnecessary surgery is also a significant problem. The percentage of physicians who furnish seriously deficient care is unknown. The Public Citizen Health Research Group (HRG)10 estimates that about 0.8% of physicians commit serious offenses each year, more than double the number actually disciplined. Practitioner discipline is covered in Chapter 25. The mental health marketplace is replete with un- qualified therapists, some of whom have no training whatsoever (see Chapter 6).
Most dentists provide competent care, but consum- ers should be alert to the signs of overselling and dental quackery. Dodes and Schissel11 also warn that many dentists fail to get optimal results because they work too quickly (see Chapter 7). Many people who represent themselves as “nu- tritionists” lack adequate training and engage in un- scientific and quack practices (see Chapter 11). Many commercial weight-loss clinics lack qualified personnel and promise too much in their advertising (see Chapter 12). A wide variety of practitioners engage in “alterna- tive” practices that are not science-based and lack proven value. This includes small percentages of medical and osteopathic physicians; large percentages of chiropractors, naturopaths, massage therapists, and acupuncturists; and others whose activities are described in Chapters 8 and 9.
fIgure 1-2. Homeopathic product “for the relief of colds and flu-like symptoms, such as fever, chills and shivering, body aches and pains.” The box states that its active ingredient is “Anas barbariæ hepatis et cordis extractum HPUS 200C.” This ingredient is prepared by incubating small amounts of a freshly killed duck’s liver and heart for 40 days. The resultant solution is then filtered, freeze-dried, rehydrated, repeatedly diluted, and impregnated into sugar granules. The “200C” designation means that the dilution (1:100) is done 200 times. If a single molecule of the original substance were to survive the dilution, its concentration would be 1 in 100200 (1 in 10400). The number 100200 is vastly greater than the estimated number of molecules in the universe. These numbers don’t make sense, and neither does purchasing the product. Ye, as noted in Chapter 8, t it is legal to market it as a nonprescription drug in the U.S.
Part One Dynamics of the Health Marketplace8
The quality of care in hospitals and nursing homes varies considerably from one to another. The best ones have well-trained nurses who monitor their patients closely. In some facilities, unlicensed personnel provide services for which they are not adequately trained. Pa- tients confronted with a succession of tests and consul- tants may feel frustrated and bewildered if the reasons for them are not explained. Noise may interfere with getting adequate rest. In some nursing homes, physical restraints or sedative drugs are used excessively, patients receive insufficient medical attention, and neglect by the nurs- ing staff results in infections and bedsores. Hospitals, long-term care facilities, and other health-care delivery systems are discussed in Chapter 22.
problems wItH Costs and aCCess
Rising costs and lack of adequate insurance coverage have made high-quality health care unavailable to many people in the United States. The cost of health care in the United States has risen much faster than inflation for several decades and is approaching 18% of our gross domestic product. In 2009 close to 50 million Americans ages 19 to 64 had no health insurance12 and many others were underinsured. A recent study13 concluded that ill- ness and medical bills were linked to nearly two thirds of bankruptcies. Inefficiency, waste, and fraud are also serious problems. In 2009, after decades of inaction, the U.S. Congress enacted a hotly contested reform bill in an attempt to improve access and decrease the cost of health care. However, the new law only partially addresses the prob- lems, and powerful vested interests and many confused members of the public oppose its implementation (see Chapters 23 and 24). The funeral industry has a disgraceful record of price-gouging. Many funeral directors fail to disclose costs, add dubious items to their bills, and/or pressure emotionally vulnerable survivors into spending more than necessary (see Chapter 21). Although comparison shopping or joining a memorial society can greatly lessen the cost of death care, many people are not in a position to do these things. Prepaid funeral plans that are badly managed or fraudulent are also a serious problem.
problems wItH rIsK perCeptIon
People are most likely to take steps to take care of themselves when they perceive that doing so will reduce important health and safety hazards. But risk-communi- cation expert Peter M. Sandman, Ph.D.14 has concluded:
If you make a list of environmental risks in order of how many people they kill each year, then list them again in order of how alarming they are to the general public, the two lists will be very different. . . . The risks that kill you are not necessarily the risks that anger and frighten you . . . .
Media reports can greatly influence what people perceive as hazardous. For example, at various times, the media have promoted widespread fears that cellular phones, video display terminals, coffee, electric blan- kets, the artificial sweetener saccharin, commercial hair dyes, and potato chips pose serious risks. The American Council on Science and Health15 has noted that all of these scares were based on “questionable, hypothetical, or nonexistent scientific evidence.” FDA scientist Robert Scheuplein16 has noted that “scientists, managers and regulators who study risks for a living are constantly dismayed because the public seems to worry about the wrong risks.” Chapter 14 discusses health and safety risks and appropriate consumer responses to these risks.
tHe need for Consumer proteCtIon
The caveat emptor doctrine (“let the buyer beware”), which originated in the Middle Ages, was based on the assumption that buyers and sellers had equal bargain- ing positions. This was reasonable because (a) goods (such as fresh vegetables and cloth) could be examined thoroughly for defects and (b) people bargained almost entirely with neighbors who risked severe social reper- cussions if they acted dishonestly. However, as trade expanded and technology advanced, it became apparent that individual caution is not enough. Even highly intelli- gent individuals may go astray in situations in which they lack expert knowledge or are emotionally vulnerable.
Protective Forces Because the caveat emptor philosophy is inadequate to protect health consumers, many of today’s laws are based on the concept of caveat vendor (let the seller beware), but gaps in consumer protection remain. Better enforce- ment of existing laws is also needed. The FDA is concerned about the safety, effective- ness, and marketing of foods, drugs, cosmetics, medical devices, and other health-related products. The FDA operates under powerful laws but lacks sufficient re- sources to handle the enormous number of violations it encounters. In addition, a 1994 law generated by the health-food industry and its allies has decreased the agency’s ability to regulate claims for dietary supple- ments and herbs (see Chapters 11 and 25).
Chapter One Consumer Health Issues 9
The Federal Trade Commission (FTC) has primary jurisdiction over most types of advertising. It administers a powerful law and has been enforcing it vigorously dur- ing the past decade. But, like the FDA, it can only act against a small percentage of the problems it encounters. State attorneys general enforce several types of consumer-protection laws. In most states, however, few health-related cases are pursued. State laws for licensing health professionals set minimum requirements for training and knowledge but do not specify that practices must be science-based. Even physicians and dentists are not required by law to practice according to scientific principles, although they generally do so. The quality of state regulation varies from state to state and from board to board. Many licens- ing boards lack the resources to investigate all of the complaints they receive. Those that oversee chiroprac- tors, naturopaths, acupuncturists, and massage therapists do very little to protect consumers against unscientific practices.
Accreditation agencies set standards for educa- tion and quality of care. Those serving schools for the science-based professions generally to do an excellent job but have failed to protect students from an invasion of “complementary and alternative medicine” teachings. The agencies that oversee chiropractic, naturopathy, acupuncture, and massage therapy schools make little or no effort to prevent unscientific teachings (see Chapters 8 and 9). Accreditation of hospitals, nursing homes, and other health-care facilities generally increases the quality of their care, but it also adds to the cost of administering that care. Hospitals oversee the activities of their staffs (see Chapter 22). Those that do so effectively provide a very valuable consumer-protection service to their communities. Insurance companies and other third-party pay- ers can refuse to cover services that are excessive or unsubstantiated. However, state legislatures and courts sometimes force them to pay for inappropriate treatment.
analYsIs of Consumer-proteCtIon forCes
Table 1–2
Agency/Organization
School accreditation agencies
State licensing boards
Insurance companies
Medicare and Medicaid Managed care
plans
Professional societies Specialty boards
Advisory panels
Hospitals
Food and Drug Administration (FDA)
Federal Trade Commis- sion (FTC)
U.S. Postal Service State attorneys general Voluntary and consumer
groups
Potential Role
Improve the quality of training State laws set standards for entry into profession. Boards can act in cases of fraud, incompetence, or other unprofessional behavior
Gatekeeper function; can refuse to pay for unsubstantiated treatment
Can eject errant practitioners Can exclude or eject practitioners who don’t meet their criteria or who engage in unprofessional conduct
Set ethical standards for members Set high performance standards and ensure them by rigid examinations
Issue guidelines based on professional consensus
Credentialing and peer-review processes can restrict unqualified practitioners
Regulates food, drugs, and cosmetics; can act against drugs and devices that are not proven safe and effective
Can act against false advertising
Can stop frauds involving use of the mail Can stop fraudulent activities Can educate the public and campaign for
stronger laws
Limiting Factors
Teachings are not required to be science-based
Licensure does not ensure that a profession practices scientifically. Board resources are limited; courts may delay or overrule board actions; many dubious practitioners are unlicensed
Laws or court actions may force companies to pay for unsubstantiated procedures
Fraud can be difficult to detect Selection criteria may be based on economic factors rather than quality of care; laws and court actions can force managed-care plans to accept practitioners they don’t want
Have no legal power; cannot influence nonmembers Unrecognized boards may have low standards or be bogus
Have no legal power; some guidelines conflict with others
Practitioners not on hospital staff are unaffected; some hospitals have lax standards
Limited resources, especially if court action is required; current laws interfere with regulation of vitamins, herbs, and homeopathic products
Very aggressive but has limited resources and tends to move slowly
No recent regulation of mail-order health products Can pursue only a small percentage of complaints Many groups are underfunded; some promote
quackery
Part One Dynamics of the Health Marketplace10
practitioners and the health-food industry want the laws weakened (see Chapters 8, 11, and 25). Table 1-2 summarizes the functions and limitations of the protective forces just discussed.
IntellIgent Consumer beHavIor
Intelligent health consumers have the following characteristics: 1. They understand the logic of science and why scientific testing is needed to test and to determine which theories and practices are valid. Chapter 2 covers this in detail. They also understand and guard against their own vulnerabilities and cognitive biases (see Personal Glimpse Box on page 12). 2. They seek reliable sources of information. They are appropriately skeptical about advertising claims, statements made by talk-show guests, and “break- throughs” reported in the news media. New information, even when accurate, may be difficult to place in perspec- tive without expert guidance. Most physicians, dentists, allied health professionals, health educators, government
Professional societies set standards for their mem- bers, but they lack the force of law and have little or no influence on nonmembers. Some societies can help consumers settle disputes over billing and ethical issues. Recognized specialty boards set standards (through examinations) to identify practitioners who have achieved a high level of professional competence. Some “specialty boards” lack professional recognition, and some are bogus (see Chapter 5). Many health-related agencies and organizations issue voluntary guidelines for science-based practices. The most comprehensive set is maintained by the U.S. Preventive Services Task Force. Its reports, as discussed in Chapter 5, examine the best current evidence for benefits and harms of various screening tests and preven- tive measures and make recommendations based on the benefit/harm ratio. Voluntary and consumer groups serve as watchdogs, information sources, and legislative advocates. Some deal with many health-related issues; others deal with few. Some advocate strengthening consumer-protection laws. Groups that represent the interests of “alternative”
Cognitive bias is a general term for distortions of thinking that are difficult to eliminate and can lead to inaccurate judgment and faulty conclusions. Many types of cogni- tive bias influence choices related to health care. Some common ones are listed below. How vulnerable do you think you are to each type?
availaBility cascade: a self-reinforcing process in which a collective belief gains more and more plausibility through its increasing repetition in public discourse (“repeat something enough and it will become true”).
BaNdwagoN effect: the tendency to do (or believe) things because many other people do (or believe) the same.
halo effect: the tendency for a person’s positive or negative traits to “spill over” from one area of their personality to another in others’ perceptions of them. We are inclined to accept statements by people we like.
illusory correlatioN: inaccurately perceiving a relation- ship between two events, either because of prejudice or selective processing of information.
iNterloper effect: the tendency to value third-party con- sultation as objective, confirming, and without motive.
mere exposure effect: the tendency to express undue lik- ing for things merely because of familiarity with them.
It’s Your Decision
Cognitive Bias
iNgroup Bias: the tendency for people to give preferential treatment to others they perceive to be members of their own groups.
Negativity Bias: the tendency to pay more attention and give more weight to negative than positive experiences or other kinds of information.
Neglect of proBaBility: the tendency to completely disregard probability when making a decision under uncertainty.
overcoNfideNce effect: excessive confidence in one’s own answers to questions.
illusioN of coNtrol: the tendency to overestimate one’s degree of influence over external events.
pseudocertaiNty effect: the tendency to make risk-averse choices if the expected outcome is positive, but make risk-seeking choices to avoid negative outcomes.
reactaNce: the urge to do the opposite of what someone wants you to do out of a need to resist a perceived at- tempt to constrain your freedom of choice.
wishful thiNKiNg: the formation of beliefs and the making of decisions according to what is pleasing to imagine instead of by appeal to evidence or rationality.
zero-risK Bias: preference for reducing a small risk to zero over a greater reduction in a larger risk.
Chapter One Consumer Health Issues 11
agencies, professional societies, and health-related vol- untary organizations are reliable (for more information see Chapter 2 and the Appendix). 3. They maintain a healthy lifestyle. This reduces the odds of becoming seriously ill and lowers the cost of health care. Prudent consumers avoid tobacco products, eat sensibly, exercise appropriately, maintain a reason- able weight, use alcohol moderately or not at all, and take appropriate safety precautions (such as wearing a seat belt when driving). 4. They select practitioners with great care. It has been said that primary-care physicians typically know a little about a lot and specialists typically know a lot about a little. The majority of people would do best to begin with a generalist and consult a specialist if a problem needs more complex management. 5. They undergo appropriate screening tests and, when illness strikes, use self-care and professional care as needed. Excellent guidebooks are available to help decide when professional care is needed (Chapter 14).
6. When a health problem arises, they take an active role in its management. This entails understanding the nature of the problem and how to do their part in dealing with it. People with chronic illnesses, such as asthma, diabetes, or high blood pressure, should strive to become “experts” in their own care and use their physicians as “consultants.” 7. They communicate effectively. They present their problems in an organized way, ask appropriate questions, and tactfully assert themselves when necessary. 8. They are wary of treatments that lack scientific support and a plausible rationale. These are discussed throughout this book. 9. They are familiar with the economic aspects of health care. They obtain appropriate insurance coverage, inquire in advance about professional fees, and shop comparatively for medications, eyeglasses, and other products. 10. They report frauds, quackery, and other wrong- doing to appropriate agencies and law enforcement
Are you sufficiently informed to be able to make sound decisions? Do you maintain a healthy lifestyle? From what sources do you seek information when needed? Professional health organizations/individuals Health books, magazines, newsletters Government health agencies Advertisements, retail salespeople Newspapers Radio/television Laypersons you know To what extent do you accept statements in news reports at face value? To what extent do you accept statements in ads at face value? How well can you identify quacks, quackery, fraudulent schemes, and hucksters? When selecting health practitioners, to what extent do you: Talk with or visit before the first regular appointment? Check/inquire regarding qualifications/credentials? Ask friend/neighbor about reputation? Inquire about fees and payment procedures? Do you undergo appropriate periodic medical examinations? Do you undergo appropriate periodic dental examinations? When you have been exposed to a fraudulent practice, quackery, or a substandard product or service, to what extent do you report your experience?
Consumer HealtH profIle
Worksheet 1–2
This exercise can help you analyze your approach to health information and professional care. Place an X in the column to the right that best represents your answer. (VM = very much; M = much; S = some; L = little; N = none.) VM M S L N
Part One Dynamics of the Health Marketplace12
officials. Consumer vigilance is an essential ingredient of a healthy society. Worksheet 1-2 can help you evaluate your approach to the health marketplace.
summarY
Consumer health encompasses all aspects of the mar- ketplace related to the purchase of health products and services. Although health care in America is potentially the world’s best, many problems exist. Health information is voluminous and complex. Many practitioners fall short of the ideal, and some are completely unqualified. Quackery is widespread. The marketplace is overcrowded with products, many of which are questionable. Rising costs and lack of adequate insurance coverage have reached crisis levels. Consumer protection is limited. Only well-informed individuals can master the com- plexity of the health marketplace. Intelligent consumers maintain a healthy lifestyle, seek reliable sources of information and care, and avoid products and practices that are unsubstantiated and lack a scientifically plausible rationale.
referenCes* 1. Kaplan NL. Consumer health: The times they are a-changing.
Health Education 11(6):3, 1980. 2. Schwartz B. The Paradox of Choice. New York, 2004, Harper-
Collins Publishers, p 73. 3. Gunther M. Quackery and the media. In Barrett S, editor. The
Health Robbers: How to Protect Your Money and Your Life, ed 2. Philadelphia, 1980, George F Stickley Co.
4. Larkin M. Confessions of a former women’s magazine writer. NutriWatch Web site, March 26, 2000.
5. Schwitzer G. The future of health journalism. Public Health Forum 18(3):19e1–19e3, 2010.
6. Kashgarian M. Doctor and patient in cyberspace, or take two aspirins and e-mail me in the morning. Yale Medicine 30(2A):22–24, 1996.
7. Jarvis WT. Quackery: A national scandal. Clinical Chemistry 38:1574–1586, 1992.
8. Barrett S, Herbert V. The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods. Amherst, N.Y., 1994, Prometheus Books.
9. Gorski D. Christine Maggiore and Eliza Jane Scoville: Living and dying with HIV/AIDS denialism. Science-Based Medicine Blog, Jan 5, 2009.
10. Wolfe SM, Laurie P. Ranking of state medical board serious disciplinary actions in 2002. HRG Web site, April 2004.
11. Dodes JE, Schissel MJ. The Whole Tooth. New York, 1997, St. Martin’s Press.
12. Number of uninsured skyrockets 4.3 million to record 50.7 mil- lion in 2009. Physicians for a National Health Program news release, Sept 16, 2010.
13. Himmelstein DU and others. Medical bankruptcy in the United States, 2007: Results of a national study. American Journal of Medicine 122:741–746, 2009.
14. Sandman P. Risk communication: Facing public outrage. Peter Sandman Risk Communication Web site, Nov 21, 2001.
15. Facts vs. Fears. New York, 2004, American Council on Science and Health.
16. Scheuplein R, quoted in Segal M. Is it worth the worry? Deter- mining risk. FDA Consumer 24(6):7–11, 1990.
17. Welcome to the DOI System. The Digital Object Identifier System Web site, accessed Sept 23, 2011.
1. Benson JS. FDA activities protect public. FDA Consumer 25(1):7–9, 1991.
Author Title
Publication Volume(Issue):Pages, Year
How to Locate References The format this textbook uses for references to maga- zine and journal articles is:
√ Consumer Tip
Online documents and journal article abstracts are easily accessed through the “references” pages of the Consumer Health Sourcebook Web site (www. chsourcebook.com). Since 2000, more than 45 million online journal articles have been assigned permanent Digital Object Identifier (DOI®) numbers that enable them to be located with the search engine at www.doi.org/index. html.17 Scientific journals are also housed at medical school and hospital libraries. Many libraries have full-text online access, and most can obtain books and article reprints through the interlibrary loan process. Using Google to search for an article’s title may locate a full-text-copy that has been posted.
*In this text, citations numbered in boldface type are recommended for further reading.
Separating Fact From Fiction
One of the factors that makes America great is our freedom of speech. To maintain this freedom, we must also run a risk. False prophets can get up on pedestals (such as radio and television talk shows) and tell you almost anything they please.
Gabe Mirkin, M.D.1
Finding the occasional straw of truth awash in a great ocean of confusion and bamboozle requires intelligence, vigilance, dedication and courage. But if we don’t practice these tough habits of thought . . . we risk becoming a nation of suckers, up for grabs by the next charlatan who comes along.
Carl SaGan2
An inability to comprehend even basic statistical concepts can trans- form modern youth into victims in search of an irrational belief system that will needlessly harm, panic, and abuse.
PaSquale aCCarDo, M.D. ronalD linDSay, M.D.3
Be careful about reading health books. You might die of a misprint. Mark Twain
“By God! You can fool all of the people all of the time!”
© medical economics, 1982
Chapter Two
Consumers who wish to make intelligent decisions about health matters must address several ques- tions: What are scientific facts? How can they be
identified? To what extent should people believe what they read and hear? Where can valid information be found? This chapter explains how scientific methods are used to determine facts, how health information is dis- seminated, and how reliable information can be obtained.
How FactS are DetermineD
Trustworthy health information comes primarily through exposing hypotheses (assumptions) to critical examina- tion and testing. A hypothesis is scientific only if it is testable and can predict measurable events. It is gener- ally not a good idea to invest resources in investigating hypotheses that lack a plausible rationale. The scientific method offers a way to evaluate infor- mation to distinguish fact from fiction. It does not rely on reports of personal observations and experiences as evidence of fact. Rather, it provides an objective way to collect and evaluate data. Astronomer Carl Sagan said that “science is a way of thinking much more than it is a body of knowledge.” He also noted2:
At the heart of science is an essential tension between two seemingly contradictory attitudes—an openness to new ideas, no matter how bizarre and counterintuitive they may be, and the most ruthless skeptical scrutiny of all ideas, old and new. This is how deep truths are winnowed from deep nonsense. Of course, scientists make mistakes in trying to understand the world, but there is a built-in error-correcting mechanism: The collective enterprise of creative thinking and skeptical thinking together keeps the field on track.
The scientific method has at least three noteworthy characteristics:
• Scientific methods are essential for validating health claims and other information.
• Under the rules of science (and consumer protection), those who make a claim bear the burden of proof.
• Scientific research requires proper study design, the highest possible accuracy of measurement or observation, and appropriate statistical analysis of the findings.
• Don’t assume that information is valid simply because it is broadcast or published. No magical superforce is protect- ing the marketplace against misinformation.
• The best way to avoid errors is to use trustworthy sources of information. It is far more sensible to use reliable “in- formation filters” such as Consumer Reports on Health rather than trying to integrate newsbits on one’s own.
Keep tHeSe pointS in minD aS You StuDY tHiS cHapter
Key Concepts
First, it is self-correcting. Scientists do not assume that this method discovers absolute truth but rather that it produces conclusions that subsequent studies may modify. In this sense, science is cumulative. Second, the scientific method requires objectivity. Findings must not be contaminated by the personal beliefs, perceptions, biases, values, or emotions of the researcher. Research results often lead to new questions that should be explored. Third, experiments must be reproducible. One study, taken alone, seldom proves anything. To be valid, one researcher’s findings must be repeatable by others. As summarized by Haack4:
What is distinctive about inquiry in the sciences is . . . sys- tematic commitment to criticism and testing, and to isolating one variable at a time; experimental contrivance of every kind; instruments of observation from the microscope to the
The Scientific Method in Action5
In 1978 researchers at Mt. Sinai Hospital in Miami Beach, Florida, compared the effects of chicken soup, cold water, and hot water on the clearance rate of nasal mucus. Each liquid was consumed through a straw from a covered cup or open vessel. A videotaping system was used to record the advance of tiny radioactive discs as mucus carried them out the nose. Cold water slowed mucus flow, but chicken soup and hot water sipped from an open cup speeded it up. Since chicken soup outperformed hot water, the researchers concluded that it appeared to have a special ability to clear a stuffy nose. Mom and Grandma were right!
Personal Glimpse
Part One Dynamics of the Health Marketplace14
different studies, (c) whether it is clear that the risk marker preceded the disease, (d) whether the dose and not just the mere presence of the marker predicts disease risk, and (e) whether, in light of what else is known, it appears logical that the marker is responsible. Controlled clinical trials compare an experimental group of people who receive the treatment being tested and a control group of people who receive a different treatment or no treatment. For example, members of the experimental group may receive a pill with active ingredients, whereas those in the control group receive another treatment, an inert substance (placebo), or no treatment. Studies may be conducted “blind” or “double- blind” to minimize or eliminate the effect of bias on data collection and interpretation. In blind studies the participants do not know which treatment they receive. In double-blind studies neither the people administer- ing the treatment nor the experimental subjects know who gets what. In crossover studies participants in two or more groups are switched from one intervention to another after a specified period of time. Some studies do not use control groups. Ernst and others10 have warned that experimental subjects who receive placebos should not be classified as “untreated” and that many people fail to distinguish between a placebo response and the improvement that results from the natural course of an illness. Chapter 3 discusses this subject further. Large, randomized, well-controlled, double-blind studies in which several medical centers participate are considered the gold standard of research trials.11 Be- cause such studies are very expensive to conduct, they are reserved for questions of great importance. Long- term research (“outcomes research”) is also needed to
questionnaire; sophisticated techniques of mathematical and statistical modeling; and the engagement, cooperative and competitive, of many persons, within and across generations, in the enterprise of scientific inquiry.
The long list of references cited in Chapter 15 of this text illustrates the enormous amount of effort that can be involved in developing important conclusions.
Research Design Scientific research requires proper study design, the highest possible accuracy of measurement or observa- tion, and appropriate statistical analysis of the findings. The conclusions are then used to develop new theories or modify old ones. Science writer Rodger Doyle6 has compared the types of studies medical scientists use to investigate health and disease:
CaSe STuDieS involve systematic observation of people who are ill.
laboraTory exPeriMenTS include studies of animals, living tissue, cells, and disease-causing agents.
ePiDeMioloGiC STuDieS analyze data from various population groups to identify factors related to the occurrence of diseases.
ConTrolleD CliniCal TrialS offer the most credible evidence.
Anecdotal reports are personal observations that have not been made under strict experimental conditions. Competent researchers may use anecdotes for suggest- ing new hypotheses, but never as supporting evidence. The fact that a person recovers after doing something is rarely sufficient to demonstrate that the recovery was caused by the action taken and is not simply coincidental. Moreover, reports of personal experiences can be biased, inaccurate, or even fraudulent. Well-designed experi- ments involving many people are needed to establish that a treatment method is effective. Without them, even honest, competent doctors can be misled by their clinical experiences.7
Epidemiologists search for “risk markers” (predic- tors of a disease) by comparing people with different characteristics.8 These markers can include personal characteristics (e.g., weight, blood cholesterol levels), personal activities (taking vitamins, exercising regularly, smoking cigarettes), and environmental factors (inhal- ing radon gas or tobacco smoke) that are statistically related to specific diseases. Before concluding that any relationship is causal rather than coincidental, however, epidemiologists must consider: (a) the strength of the association, (b) the consistency of the association in
Any procedure proposed to treat human disease should be subject to the same standards of safety and effectiveness that apply to usual medical procedures. It is, however, unacceptable to require any scientific body to examine every proposed claim. There will never be enough facilities to consider the avalanche of proposals. Very simply, the burden of proof rests with the proponents. . . . Testimonials and anecdotal accounts, no matter how enthusiastic, do not constitute proof. Public enthusiasm and interest do not create validity. Edward H. Davis, M.D.9
√ Consumer Tip
Chapter Two Separating Fact from Fiction 15
compare the effectiveness of proven options.12 Table 2-1 illustrates the typical steps in a clinical investigation. It is important that research findings not be overgen- eralized. Conclusions based on data from one population may not apply to another, and the results obtained from animal or test-tube studies may not be applicable to humans. The importance of scientific testing was strikingly demonstrated by a study of mammary artery ligation, a surgical procedure used in the 1940s and 1950s for treating angina pectoris (chest pain resulting from coronary artery disease). Proponents believed that tying off the mammary arteries stimulated the growth of new blood vessels that would increase the supply of blood to the heart muscle. The procedure was considered ef- fective until double-blind controlled tests demonstrated that pretending to operate (merely cutting the skin of the patient’s chest wall) was as effective as tying off the mammary arteries.13
Misuse of Statistics Many people tend to accept statistical data without ques- tion. To them, any information presented in quantitative
form is correct. Advertisers, quacks, and pseudoscien- tists often cite invalid data or misrepresent valid data to promote their wares. Strasak and colleagues14 have identified 47 statistical errors in medical research. The common ones that can cause confusion include:
biaS: A factor that may cause people to make erroneous obser- vations or draw erroneous conclusions. For example, in a study of vitamin C and the common cold, participants who knew they were taking vitamin C reported fewer colds than those who were taking it but did not know it.15
non SequiTur: The stated conclusion does not follow from the facts.
inSuffiCienT DaTa: Small amounts of data limit the certainty of results. Tests done on small numbers must usually be confirmed by larger studies.
nonCoMParable DaTa: Care must be taken when groups are compared. For example, people who eat the most sugary cereals are at lowest risk of developing cancers. But don’t conclude that eating sugary cereals reduces cancer risk. Those who eat the most sugary cereals tend to be children, and the risk of cancer is much lower in children than it is in adults.
nonrePreSenTaTive DaTa: Improper sampling techniques (lack of random sampling) may yield data that do not accurately
tYpical StepS in a clinical inveStigation
Table 2–1
Step A question or problem is identified. A hypothesis is formulated. A limited aspect of the hypothesis is se-
lected for testing. A study is designed.
The study is conducted. Data are collected, recorded, and tabu-
lated. The data are analyzed to determine
whether the results appear significant or were likely to occur by chance alone.
A determination is made on whether the hypothesis has been supported or refuted.
The study may be repeated by the re- searchers or by others to verify their results or conclusions.
Studies relevant to this area are reviewed.
Example What is the effect of vitamin C on the common cold? Supplementation with vitamin C can reduce the incidence of colds. Will daily administration of 1000 mg of vitamin C prevent colds?
Sixty adults will be given 1000-mg tablets of vitamin C daily for 4 months, and 60 of comparable age, race, sex, and health status will be given an inactive substance (placebo tablets). The participants will not know which they receive (a blind study).
Volunteers are obtained and instructed on how to proceed. There were six colds in the vitamin C group and seven in the placebo
group. The small difference between the two groups could easily have
occurred by chance alone and therefore is not “statistically significant.”
The hypothesis was not supported. The experiment found no evi- dence that vitamin C supplements reduce the incidence of colds.
Many double-blind experiments have found that supplementation with vitamin C does not prevent colds (see Chapter 11).
Skilled reviewers agree that enough well-designed studies have been done to conclude that vitamin C megadoses do not prevent colds.
Part One Dynamics of the Health Marketplace16
represent the study population or group. For example, to determine which car the average American likes best, it would not be appropriate to poll only owners of one make of car, those living in one region, or even those listed in a telephone book (since many people have a nonpublished number, a cell phone, or no telephone). Figure 11-1 provides another example.
ConfuSion of aSSoCiaTion anD CauSaTion: A finding that taking dietary supplements is associated with fewer missed work days does not mean that dietary supplements prevent people from getting sick. Other factors associated with taking supplements, such as having a healthier overall lifestyle, may be the real reason for reduced sick days among the supplement users.
oMiSSion of an iMPorTanT faCTor: Many individuals who feel helped by an unorthodox remedy have taken it together with effective treatment but credited the unorthodox remedy.
In How to Lie with Statistics, Darrell Huff16 describes how drug research data can be misrepresented by us- ing biased samples, meaningless averages, purposeful omissions, illogical conclusions, and deceptively drawn charts. He notes that a basic technique used by charla- tans when they present testimonial evidence is the post hoc, ergo propter hoc fallacy: “This happened after that, therefore this was caused by that.” The fact that someone who smokes 50 cigarettes and drinks heavily each day lives to age 95 does not mean that these habits are healthful. Huff says that to analyze a statement, one should ask, “Who says so? How does he know? How did he find out? Is anything missing? Does it all make sense?”
Manufacturers are quick to take advantage of pre- liminary research that may appear to support increased use of their products. In 1988 the Physicians’ Health Study Group17 reported that aspirin use every other day had reduced the incidence of heart attacks among 11,000 generally healthy physicians. The researchers concluded that although aspirin might help prevent heart attacks, the study’s results should not be applied to the gen- eral population and that doctors should weigh potential risks as well as benefits when advising their patients. (Chapter 17 discusses this further.) Within days after the report was published, aspirin ads began referring to it and suggested that consumers ask their doctors whether aspirin might help them. The FDA commissioner, who believed that the ads were likely to encourage inappropri- ate self-medication, warned manufacturers that aspirin did not have FDA approval for preventing heart attacks in healthy people and that continuing the ads would trig- ger regulatory action. Fish oils, calcium supplements, antioxidant vitamins, and high-fiber products have also been marketed in ways that oversimplify or exaggerate the significance of research findings.
peer review
Peer review is a process in which work is reviewed by others who usually have equivalent or superior knowl- edge. It may be used during the development or execu- tion of a study, as well as afterward. When studies are completed, researchers strive to publish their results in journals so that others can use or criticize the findings and science can advance. Detailed standards for report- ing and evaluating studies have been published.18 The best scientific journals are peer-reviewed by experts; papers submitted for publication are reviewed by two or more expert referees, then accepted, modified, or rejected by the editor. The peer-review process is im- perfect but can usually screen out “obviously flawed and unreliable manuscripts.”19 Reports from more than 5000 peer-reviewed scientific journals are listed in the Index Medicus and its online counterpart MEDLINE. Such listing is a favorable sign but not a guarantee of quality. The quality of peer review varies from journal to journal, and even the best ones occasionally publish articles that deserve to be rejected. Moreover, in recent years, many low-quality journals that promote unsci- entific (“alternative”) methods have been included in the Index Medicus. The two most prestigious American medical journals are JAMA (Journal of the American Medical Association) and The New England Journal of Medicine. JAMA has more than 3000 names in its reviewer-referee file.
Personal Glimpse
Self-Persuasion Charlatans are not the only people who engage in the post hoc, ergo propter hoc fallacy. As noted by Lisa Feldman Barrett, Ph.D., professor of psychology at Northeastern University:
People try to connect things that happen to them. In doing this, they lean toward ideas that fit their expectations and away from those that do not. Suppose somebody believes that vitamins provide energy. On a day when he feels energetic, he attributes that feeling to the vitamin, rather than to other factors, such as the quality of his sleep the night before. On a day when he feels fatigued, however, he doesn’t register the experience as evidence against his belief. The scientific method safeguards against these tendencies by forcing people to look at disconfirmatory evidence and examine alternative explanations.
Chapter Two Separating Fact from Fiction 17
Systematic Reviews A systematic review is a literature review focused on a single question that tries to identify, appraise, and synthesize all high-quality research evidence relevant to that question. Systematic reviews of high-quality randomized, controlled trials are crucial to evidence- based medicine. The selection of articles for inclusion is usually performed by reviewing the titles and abstracts of the articles identified and excluding those that do not meet eligibility criteria. Then the data are abstracted in a standardized format. The methods used to gather and analyze the data should be transparent enough to allow others to repeat the process. Systematic reviews commonly include a meta- analysis, a statistical approach for “averaging” the results of studies that address closely related research hypotheses. When doing this, the reviewers must give appropriate weight to the quality and size of each study. If the studies differ so much that it makes no sense to try to find an average effect, the reviewers will not do a meta-analysis. Systematic reviews can be done by organizations and agencies as well as by individuals. Several that are given great weight by the medical community are described here. The American Medical Association’s Council on Scientific Affairs studies many medical issues and re- ports to the AMA’s House of Delegates. Once accepted, these reports help shape AMA public policies and may be published in JAMA. The National Academy of Sciences issues the Di- etary Reference Intakes (see Chapter 10) and many other reports by expert committees. The National Institutes of Health Consensus De- velopment Program, begun in 1977, has held about 100 consensus conferences in which experts meet for several days to discuss a topic and issue a report. Except for the acupuncture report (discussed in Chapter 8), the reports reflect a scientific consensus. The American College of Physicians’ Clinical Ef- ficacy Assessment Project focuses primarily on relatively new procedures. The U.S. Preventive Services Task Force publishes recommendations for preventive services that prudent health professionals should offer their patients in the course of routine clinical care. These recommendations, which represent the pooled judgment of many experts, are discussed in Chapters 5, 14, and 19. The Agency for Health Care Research and Quality (AHRQ), a component of the U.S. Public Health Ser- vice, was established in 1989 to enhance the quality,
appropriateness, and effectiveness of health services. Formerly called the Agency for Health Care Policy and Research (AHCPR), it has published many clinical practice guidelines with separate versions for clinicians and consumers. The Cochrane Database of Systematic Reviews, updated quarterly, is an electronic journal of systematic reviews produced by the Cochrane Collaboration, an international network of individuals and institutions committed to preparing systematic reviews of the effects of health care and disseminating them on CD-ROM and through the Internet. Established in 1993, it hopes to cover the entire spectrum of medical interventions.20
The National Guideline Clearinghouse (NGC) is an Internet-based public resource sponsored by the AHRQ, in partnership with the AMA and America’s Health Insur- ance Plans. The Web site summarizes more than 2500 clinical practice guidelines that have met its criteria. It should be noted, however, that NGC does not develop, produce, approve, or endorse the guidelines represented on its site and that some promote unscientific practices that this book criticizes in Chapters 8 and 9. Poor quality reviews can lead clinicians to the wrong conclusions and ultimately to inappropriate treatment decisions. In 2011, the Institute of Medicine (IOM) addressed this issue by recommending standards for systematic reviews21 and the development of clinical practice guidelines.22
Publication Bias Scientific journals are more likely to publish positive studies than negative ones. This occurs because editors and reviewers tend to favor positive results and experi- menters are more likely to write up studies with positive findings than with negative findings.23 The resultant situation—referred to as publication bias—may make something appear more significant than it actually is. Publication bias was vividly demonstrated by a study in which three versions of a bogus article were sent to 101 consulting editors of two psychology journals. The submissions were identical except that one reported positive results, one reported near-positive results, and the third reported no significant results. The positive versions received three times as many recommendations for publication and were rated as better designed.24
In recent years, drug companies and researchers have been accused of suppressing studies and data unfavor- able to their products.25 In response to this concern, 11 medical journals announced that in 2005 they would stop considering reports of clinical trials that had not been registered in a public trials registry before or at the time
Part One Dynamics of the Health Marketplace18
they began to enroll patients.26 The need for the policy was underscored by a study of 122 journal articles that concluded that about half of them had been incompletely reported, harm was more likely to be unreported, and 65% had inconsistencies between primary outcomes defined in the most recent protocols and those defined in published articles.27
Conflict of Interest Financial conflicts of interest can affect the objectivity and trustworthiness of research conduct and publications. For example, researchers whose funding comes from a drug company may be concerned that negative reports may cut off future funding. Industry is now the leading funder of medical research, and much research is con- ducted in nonacademic settings. Industry also is involved in funding evidence reviews and practice guidelines. Conflicts of interest cannot be completely elimi- nated, but awareness of the problem has increased the use of countermeasures. For example, prospective medical journal authors and speakers at accredited courses are required to provide a written disclosure of any financial tie they may have to the subject matter. The IOM28 has urged medical institutions to strengthen their conflict- of-interest policies and asked Congress to require health-related manufacturers to publicly disclose pay- ments they make to pharmaceutical, biotechnology, and device firms and to report through a public Web site the payments they make to doctors, researchers, academic health centers, professional societies, patient advocacy groups, and others involved in medicine. Scientific Misconduct Occasionally, individual scientists publish or attempt to publish bogus research data. The extent of this type of fraud is not known, but its existence presents one more argument for replicating studies. Peer review, high- quality journals, and the demand for replication make detection likely when fraud occurs. Physicist David Goodstein, who has worked with federal agencies to develop guidelines for defining misconduct in science, reported that between 1980 and 1987 only 21 cases of misconduct involving doctors or biologists came to light—which was only three ten-thousandths of all scientists who received research grants.29 Unconfirmed studies, particularly when inconsistent with other stud- ies, seldom have a major impact on what physicians do. Thus, although scientific fraud occurs, it seldom affects patient care. One corrupted study that did affect patient care was published in 1998 by The Lancet, Britain’s premier
medical journal. In it, Dr. Andrew Wakefield and col- leagues suggested that the measles-mumps-rubella (MMR) vaccine might be linked to autism. The paper didn’t declare that cause-and-effect had been dem- onstrated, but at the press conference announcing its publication, Wakefield attacked the triple vaccine, and he has continued to do so ever since. Subsequent stud- ies have found no connections, but sensational public- ity caused immunization rates in the United Kingdom to drop more than 10% and has left lingering doubts among parents worldwide. In 2010, the British Gen- eral Medical Council, which registers doctors in the United Kingdom, concluded that Wakefield had acted dishonestly, irresponsibly, unethically, and callously in connection with the research project and its subsequent publication. Lancet retracted the paper 5 days later, and Wakefield’s medical license was subsequently struck from the register.30
truStwortHineSS oF SourceS
It can be extremely difficult for consumers, and some- times even for health professionals, to determine the accuracy of health information. Separating fact from fiction can be a complex and time-consuming process. The reasons for this difficulty include:
• Advice from laypersons may be based on hearsay and personal experience rather than scientific data. Factual information, especially when several individuals are in- volved, is often distorted in transmission.
• Many false ideas “feel right” or seem commonsensical to people who lack the technical knowledge to evaluate them.
• Preliminary and limited scientific studies may be overem- phasized by the media.
• Research data published by experts may conflict sufficiently to cause public confusion.
• Inaccurate health information may be disseminated purely for reasons of self-interest or profit.
• Claims that treatments are based on scientific evidence may not be true. Schick and Vaughn31 have noted that un- scientific practitioners often cite or misconstrue “scientific findings” to support their views.
• “Confirmation bias” can play a decisive role. As noted by Carroll,32 people tend to give more weight to data that support their beliefs, and those who become blinded to evidence refuting a favored hypothesis “cross the line from reasonableness to closed-mindedness.”
Hitchins33 has noted that “extraordinary claims require extraordinary evidence and that what can be as- serted without evidence can also be dismissed without evidence.”
Chapter Two Separating Fact from Fiction 19
Professionals. Most health professionals give reliable advice, but scien- tific training does not guarantee reliability. For example:
• Adelle Davis promoted inaccurate and dangerous nutrition advice despite adequate training in nutrition. As noted in Chapter 11, many of the scientific studies she cited to back up her theories had no relevance to them.
• Robert Atkins, M.D., best known for his low-carbohydrate diet, promoted many types of disreputable treatments (see Chapter 12).
• Andrew Weil, M.D., a Harvard Medical School graduate, mixes sound and unsound advice (see Chapter 11).
Several chapters of this book suggest how to identify professionals who engage in unscientific practices. Many lines of questionable nutrition products have been marketed with endorsements by scientists with respectable credentials. The most notable case occurred with United Sciences of America, Inc., a multilevel company that sold dietary supplements claimed to be effective in preventing cancer, heart disease, and many other diseases. Literature from the company said that its products had been designed and endorsed by a 15-per- son scientific advisory board that included two Nobel prize-winners. However, four members of the board told investigators that they had neither designed nor endorsed the products. A few other multilevel companies claim to be guided by scientific boards, and a few supplement manufacturers have used endorsements by individual practitioners in advertisements. Barrett,34 who believes that all such practitioners hold minority viewpoints, has warned:
Vitamin product endorsements by doctors—no matter how prestigious they are—should be viewed with extreme cau- tion. All I have seen so far have included claims that were unproved and also illegal.
Nonprofessionals. Many consumers have misconceptions about the factors that influence health. People who share their experiences and knowledge may believe in unproven and unscien- tific methods. Such people often are highly motivated to spread their beliefs. Testimonials from movie stars, professional athletes, and other celebrities are commonly used to promote questionable health methods. National organizations exist to promote “alternative” cancer rem- edies (Chapter 16), the Feingold diet (Chapter 6), and other dubious methods. Millions of people have been involved in the sale of dietary supplements and other products through multilevel companies such as Herbalife and The Trump Network (see Chapter 4).35
Pseudoscientists. A pseudoscience is a set of ideas put forth as scientific when they are not. Pseudoscientists misuse and distort scientific evidence to support whatever products or services they promote. They may use scientific terminol- ogy and data to concoct theories that seem plausible to laypersons. They are often sophisticated in manipulating situations to gain notoriety and acceptance. They may write articles and books and may also reach consumers through television and radio programs. Some are “nutri- tion consultants” with “degrees” from diploma mills and nonaccredited schools. Several observers have described characteristics that can help consumers distinguish pseudoscientists from true scientists. Hatfield,36 for example, has noted:
Generally speaking, an establishment scientist has attended and graduated from an accredited university, belongs to one or more well-respected professional organizations, conducts carefully controlled and documented research, and reports these findings in professional journals that maintain high standards for accepting research papers. By contrast, those claiming to be an alternative to es- tablishment science have no common set of standards or practices from which measurements and comparisons can be made or quality of performance judged. Personal testimonies and causal observations quite often serve as the basis of their research rather than act as the impetus to begin research.
Peterson37 has likened improperly designed research to a man rowing a boat from only one side:
No matter how long or how hard he works, he never succeeds in doing anything except going in a circle, never realizing that it isn’t his dedication or his strength but his method that is flawed. Until fringe research puts both oars in the water, it is doomed to remain where it has always been: spinning aimlessly near the shores of science.
True medical scientists have no philosophical commitment to particular treatment approaches, only a commitment to develop and use methods that are safe and effective for an intended purpose. Several observ- ers have noted that pseudoscientists use hypotheses and data differently from scientists. Whereas scientists test hypotheses, abandon disproved ones, and welcome re- view of their findings and conclusions, pseudoscientists reject findings that contradict their beliefs and accuse critics of prejudice and conspiracy.38,39
In this regard, Criss40 explains why we should not as- sume that people with strange ideas are modern Galileos:
To be a true analogy, these people would have to do experi- ments, make observations, and bring these results for all to
Part One Dynamics of the Health Marketplace20
see and question in an open forum. Further, they would have to be denied freedom of speech and press, or any expression all over the land—for that was the injunction against Galileo in 1616! It was as a result of this experience that the scientific method was adopted among scientists. . . . It has allowed the replacement of old ideas with new ones, and has provided a means of judging, and discarding, unfounded ideas.
Beyerstein43 has noted that “alternative” practitioners rarely produce scientific data:
Unless an unconventional therapist keeps detailed records of a sufficiently large number of patients with the same complaint, we have no way of knowing whether the reported number of “cures” exceeds the normal unaided rate of recovery for the symptoms in question. Fringe practitioners rarely keep such data, preferring to publicize lists of satisfied customers rather than the percentage of the total cases that they represent. In addition, because alternative healers practically never carry out long-term follow-up studies, neither do we know how many of their clients receive temporary symptom relief rather than a genuine cure.
Educational institutions. Educational standards are maintained through a sys- tem of accreditation by agencies approved by the U.S. Secretary of Education or the Council on Recognition of Postsecondary Accreditation. Accredited institutions tend to have well-trained faculty members and provide reliable guidance to their students. However, Chapters 8 and 9 note that acupuncture, chiropractic, naturopathy, and massage therapy schools have their own accredita- tion agencies, even though much of their teachings are unscientific. Nonaccredited schools that teach health subjects are usually untrustworthy, and some are diploma mills that issue “degrees” and certificates whose only requirement is the payment of a fee. Chapter 11 discusses the problem of bogus nutrition credentials. Many elementary and high school teachers of health subjects have had minimal formal training in these subjects and hold beliefs similar to those of the general public. Consequently, many misconceptions are passed from teacher to student. In 1983, Dr. Roger Lederer, professor of biology, and Dr. Barry Singer, associate professor of psychology, California State University,44 noted that problems existed even at universities:
In recent years the teaching of pseudoscience and quackery in universities has become common and apparently accepted under the aegis of academic freedom. Typically the material is not formally presented as “Pseudoscience 101,” but is offered as a component of a regular course.
Over the years, at many schools, the situation has become even worse. As Mole45 has summarized:
“Science and society” classes do not nurture the critical think- ing abilities of students. They only nurture a deep suspicion toward all truth claims, particularly those claims perceived to clash with the political ideals of students. . . . If there are no valid criteria for accepting the truth of science, then virtually any idea about the empirical world is valid and there are no authoritative reasons to reject or accept any particular idea.
Many medical schools, hospitals, and professional organizations offer courses they identify as “alternative,” “complementary,” and/or “integrative” methods. Some are appropriately critical, but most provide a forum for promoters. The Accreditation Council for Continuing Medical Education (ACCME) states that “all the recom- mendations involving clinical medicine in a CME activ- ity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.” However, the ACCME has been very lax in
Historical Perspective
The Pseudoscience of Biorhythms
Creation of biorhythm theory is attributed to Wilhelm Fleiss, a German surgeon who postulated in the 1890s that behavior was determined by innate “male” and “female” rhythms of the body. Current theory postulates three cycles: a 23-day physical cycle, a 28-day emotional cycle, and a 33-day intellectual cycle. Proponents claim: (a) each cycle begins at the exact moment of birth and oscillates up and down with absolute precision throughout life; (b) when the cycles are high, people are likely to be at their best; when they are low, the opposite is true; and (c) on critical days, when the cycles are changing, people are easily distracted and most prone to accidents. Bainbridge41 asked 108 students whether their biorhythms, which he calculated for them on a particular day, were valid. The majority said yes. Unknown to them, however, he had determined their values by flipping a coin. Hines42 subsequently reviewed more than 20 years’ worth of studies and found no evidence to support the claims of biorhythm theory. The human body has real, objectively measurable biologic rhythms that have nothing to do with the aforementioned “biorhythms.” Growth hormone and cholesterol production, for example, tend to peak while people are asleep at night. The science of repetitive and cyclic biologic rhythms is called chronobiology.
Chapter Two Separating Fact from Fiction 21
enforcing this policy.46 As a result, chelation therapy, bogus anti-aging practices, homeopathy, and many of the other dubious methods mentioned throughout this book are promoted through organizations that the ACCME accredits.
Print and Electronic Media Max Gunther47 has succinctly described the role of the media in disseminating health information:
The media have four main functions: to entertain, to inform, to carry advertisements, and to make money for their stockhold- ers. Because of the ways in which these functions are carried out, and the peculiar and intricate ways in which they are connected, an appalling amount of misinformation—ranging from the faintly biased to the downright wrong—is fed every day to an unfortunately gullible public. Hardly anywhere is this more evident than in the fields of medicine and its unwanted cousin, medical quackery.
Publicity is obviously a major factor in the success of quackery. Controversy often works to the advantage of quacks. During the mid-1970s Laetrile (amygdalin) promoters skillfully orchestrated publicity to increase their public following. Court cases of children whose parents wished to withhold conventional therapy
became a rallying point. Laetrile supporters who sin- cerely believed it had saved their lives gained access to national television, where they appeared quite credible.48 During the past several years chiropractic, homeopathy, and other “alternative” methods have received consider- able publicity in mainstream publications with little or no attempt to examine their shortcomings. When the media attempt to present health informa- tion, problems are often evident: (a) coverage of a subject is inadequate because of the limited time allotment; (b) selection or screening of speakers or subject areas is poor; (c) pseudoscientific claims often are presented without rebuttal from qualified experts; (d) attempts are made to sensationalize and overdramatize preliminary or new findings, especially about cancer, heart disease, arthritis, or alleged environmental dangers (Figure 2-1); and (e) attempts are made to attract large audiences with claims that “alternative” methods are effective. Koren and Klein49 have noted that the media have a natural tendency to report more on positive medical findings than on negative ones. This tendency contributes to the difficulty laypersons have in placing medical news in perspective. Barrett and Herbert50 note additional factors in the spread of misinformation by the media:
• Magical claims about health methods tend to be regarded as more newsworthy than established facts. Nationally tele- vised talk shows provide enormous publicity for promoters of quackery.
• Time works to quackery’s advantage. It is much easier to report a lie as a straight news event than to investigate it.
• Some journalists who have been misled by false ideas can- not write accurate reports.
• Most promoters of health misinformation are regarded as underdogs in a struggle against the establishment. As such, they tend to be treated with undeserved sympathy. Most editors insist that articles that attack false ideas be balanced so that the apparent “underdog” gets a fair hearing. Even science editors rarely feel a duty to issue effective public warnings against misinformation.
• Many more people are actively promoting misinformation than are actively opposing it. The sheer force of numbers works against the truth.
• Publications that accept ads for food supplements may be unwilling to risk offending their advertisers. For example, when Self magazine published an article by a freelance writer listing money-saving tips from the 1980 edition of this book, a tip about spending less money on vitamins was deleted from the writer’s manuscript by the magazine’s editors.
• Many editors fear that attacks on nutrition quackery will stir up controversy from readers who regard nutrition as their religion.
Figure 2-1. Magazine cover, 1992. Sales for this issue topped all others during the first half of the year. The six- page story, which speculated about antioxidant vitamins, was hailed by the health-food industry as a “watershed” event. In 1996, after studies refuting these speculations were published, Time covered the subject only briefly.
Part One Dynamics of the Health Marketplace22
• Many editors fear that attacking the credibility of a quackery promoter will result in a libel suit.
Although libel suits related to health issues are rare, other forms of economic reprisal are not. Some manufac- turers cancel or threaten to cancel ads when magazines run articles that criticize their products, and “alternative” practitioners often initiate letter-writing campaigns or cancel their subscriptions when publications criticize their methods. After publication of the third and fourth editions of Consumer Health, chiropractors attempted to execute a boycott52 and bring other pressure on the publisher to make the book’s discussion of chiropractic more favorable. Many publications use sensational claims to generate sales. Tabloids and women’s magazines, for example, frequently carry articles on “quickie” reducing diets or “superfoods.” Marilynn Larkin,53 a freelance writer in New York City, has noted that topic selection is com- monly based on sales appeal rather than scientific merit. Even a well-written article may be accompanied by a sensational headline that contradicts the article itself.
Newspaper headlines are often composed by an editor who did not write the article and is not well-versed in the subject matter. Paul Offit, M.D., chief of infectious diseases at Chil- dren’s Hospital of Philadelphia, has noted that counter- ing misinformation—even with a mountain of evidence available—can be a challenge. Referring primarily to the spread of false claims that vaccines are dangerous, he said, “It’s very easy to scare people; it’s very hard to unscare them.”54
Lack of peer review. Scientists are generally eager to point out the deficiencies in each other’s theories and experimental techniques. Journalists, however, almost never publicly criticize each other’s coverage of the news. This is particularly true when health topics are involved. Stories about “alterna- tive” methods rarely enable readers to judge whether proponents’ claims are true. Skeptical Inquirer, Skeptic, and the antiquackery Web sites are among the very few that publish unrestrained criticisms of poor reporting. The National News Council was founded in 1973 “to serve the public interest by . . . advancing accurate and fair reporting of news.” It investigated complaints alleging unfairness, inaccuracy, or breaches of ethical standards by wire services, newspapers, news syndicates, news magazines, and television and radio networks and stations. The Council exerted some pressure on media outlets, but its findings were not widely publicized. It ceased operation in 1984, citing lack of media support as the primary reason. Some media outlets have referees (ombudsmen)55 to whom complaints can be made, but misleading health reports are rarely investigated.
Advertisements. Many periodicals contain ads encouraging their readers to buy vitamins and minerals, herbs, wrinkle remov- ers, weight reducers, headache-relief drugs, pep pills, and various other health-related products. Advertising, however, is frequently misleading—often deliberately so. Advertising claims often have multiple meanings, one or more of which may be false. Many ads describe a product in terms of a mystical ingredient rather than specific contents or values. Advertising dollars can also affect what gets pub- lished. Gunther47 has observed: “Fear of losing good advertisers is one of the common reasons why worthless medicines and gadgets and treatment methods get free plugs and why you do not see honest medical rebuttals printed as often as could be wished.” Chapter 4 discusses this subject further.
Personal Glimpse
Pseudo-Balance It isn’t just the shiny magazines that give unproven medicines such an easy ride. What is the attraction of unproven medicines for the weightier news publications. . . . Surprising angles, new scoops, wonder cures and personal accounts are all a lot more interesting to most readers than a bunch of hard statistics, and unproven remedies tend to be strong on personal anecdotes (and, of course, the one thing that unproven remedies can’t provide is decent data!) Journalists also need to give more than one opinion. In many health features and interviews, unproven alternative therapy can often seem like the perfect antidote to a dry medical expert. “Traditional” therapies versus “modern medicine,” or “natural” versus “pharmaceutical,” or “herbal” versus “drug”-- the contrasts make for a compelling feature story. But the trouble is, the two “sides” may not be as equal as they seem. . . . Better investigative features do more than hang an argument between opposing views. They consider the ordering of these views carefully, and seek to position and frame information so that readers can understand the merit of each viewpoint. Clare Bowerman51
Chapter Two Separating Fact from Fiction 23
Newspapers. Many newspapers use overdramatization of incidents, inaccurate or exaggerated reports, quotations from unreliable sources, and misleading headlines to attract reader interest and attention. The weekly tabloids are notorious for this. HealthNewsReview.Org, a project of the Founda- tion for Informed Medical Decision Making, provides independent expert reviews of news stories. Among other things, its reviews look for adequate analysis of the qual- ity of the evidence and whether new ideas are compared with existing options.56 In 2010, after reviewing more than 1000 stories by more than 70 news organizations, the organization reported that about 70% of stories overemphasized benefits, minimized harms, and failed to adequately discuss costs.57
Consumers should be wary of reports indicating that studies were completed on small numbers of subjects, done in foreign countries (evidence of accuracy is more
difficult to ascertain), or based on animal studies alone. Preliminary findings can be important, but they do not become established as facts unless additional studies support them.
Magazines and Newsletters. Magazines and newsletters differ widely in the accu- racy of the information they publish. In 2006, experts associated with the American Council on Science and Health59 evaluated the nutrition information in 22 popular magazines from 2004 through 2005. Up to 10 articles from each magazine were examined for accuracy, readability, substantiation of contents, and reliability of recommendations. Consumer Reports scored highest, followed closely by Glamour, Ladies Home Journal, and Shape. The worst were Cosmopolitan, Muscle & Fitness, and Men’s Fitness. Although Consumer Reports’ coverage of health topics is generally reliable, it has virtually ignored the dubious practices described in Chapter 8 of this book. In 2011, for example, it reported the results of a survey of readers who were asked about their experiences with acupuncturists, chiropractors, and massage therapists. The article stated that the survey data might not represent the experiences of the general population and should not be compared to the results of clinical trials. However, in- stead of warning about the risks of consulting such these practitioners, the article recommended using proponent organizations to help find them.60
The major news magazines, Time, Newsweek, and U.S. News & World Report, are good sources of news on general health topics. Their articles are usually timely, well-written, and based on interviews with recognized experts. However, all three of these magazines have publicized news about “alternative” health methods without appropriate critical analysis.61 Newsweek has also published several unduly alarmist articles about environmental factors and co-sponsored the 1996 Las Vegas Health Show, a large exposition at which many speakers and exhibitors promoted unscientific methods. Many periodicals specialize in health-related infor- mation. Dr. Barrett, who monitors many of them, has summarized his ratings in Table 2-2.
Books and other Literature. Thousands of health-related books, booklets, and pam- phlets are published each year. The First Amendment of the Constitution protects free speech and thus, un- fortunately, permits authors to publish inaccurate and misleading health information as long as it is not directly tied to the sale of products.
Would You Buy this Newsletter? You have just received in the mail a 20-page booklet promoting a new newsletter. The booklet’s cover pictures the editor, Julian Whitaker, M.D., who asserts:
“Give Me 90 Days And I’ll Help You . . . • Avoid headaches, sleep problems, depression
and other everyday maladies . . . . • Unclog heart arteries that cause high blood
pressure, stroke and heart attack . . . . • Tap your body’s natural reserves to beat fa-
tigue and have the energy to do the things you love….
• Avoid—and even reverse—the symptoms of arthritis and most forms of diabetes . . . .
• Disease-proof your body and add many good years to your life! Life-enriching program boosts your body’s amazing power to heal itself!”58
The booklet describes Dr. Whitaker as “America’s leading advocate of a safer, gentler approach to better health.” It also identifies him as “a leading member of the American College of Advancement in Medicine” and states that his clinic in California “helps thousands to find a healthier, non-toxic approach to life, and to reverse heart disease, arthritis, diabetes, and many other illnesses.” Do these claims seem credible? How can you investigate them?
It’s Your Decision
Part One Dynamics of the Health Marketplace24
HealtH anD nutrition perioDicalS aligneD witH tHe ScientiFic communitY
Table 2–2
General Health Newsletters
Consumer Reports on Health Harvard Health Letter
Harvard Heart Letter Harvard Women’s Health
Watch Health Over 50 (Johns Hop-
kins Medical Letter) Mayo Clinic Health Letter Public Citizen HRG Health
Letter University of California at
Berkeley Wellness Letter
Nutrition Newsletters
Environmental Nutrition
Nutrition Action Tufts University Health &
Nutrition Letter
R D P S T R S T
4 4 4 4 4 3 2 3 3 4 4 4 4 3 2 3
4 4 4 – 4 4 – 4 3 4 4 4 4 3 2 3
4 4 4 3 4 4 2 4
4 3 4 4 4 4 3 4 3 3 2 1 4 4 2 2
4 4 4 4 4 4 4 4
3 3 4 3 4 1 2 3
3 3 3 2 4 4 3 4 4 3 4 4 4 3 2 3
Comments
Outstanding; packed with practical information Excellent reports on research findings, but some articles
on “alternative” methods have been promotional Outstanding but limited to cardiovascular topics Some articles on “alternative” methods have been
promotional Excellent and timely
Excellent and timely Unduly negative about health marketplace; some conclu-
sions based on inadequate data sampling Excellent and timely; frequently attacks misinformation
Best features are news and book reviews; some articles about supplements and herbs have been misleading
Alarmist attitude toward nutrition and food safety Nearly all articles are related to nutrition; most are infor-
mative and practical
Each of the newsletters and magazines in the chart below presents valuable information. Some deal with controversial topics much more than others, whereas some deal with them less accurately than others. Some cover many topics superficially, whereas others cover fewer topics deeply. Some balance this mix according to the importance of the topic. Generally the broader the scope, the less thorough, and vice versa.
R = How reliable? 4 = Excellent D = How thorough? 3 = Good P = How practical? 2 = Fair S = How broad a scope? 1 = Inconsistent T = How timely? 0 = Poor
General Topics Quackery
The following are not recommended because they promote unscientific and/or unproven methods. Some are no longer published. Newsletters: Allergy Hotline; Alternative Health Issues; Alternatives (written by David Williams, D.C.); Antha; Better Ways to Health; Bio-Probe
Newsletter; Bottom Line Health; Cancer Chronicles; Dr. Atkins’ Health Revelations; Dr. William Campbell Douglass’ Real Health; Forefront; Health & Healing; Health Alert; Health & Longevity; Health Resource Newsletter; Health Wisdom for Women; HealthBeat; HealthFacts; Healthy Talk; The International DAMS Newsletter; The John R. Lee, M.D., Newsletter; The Lark Letter; The McDougall Newsletter; The Mindell Report; NaturalCures newsletter; Naturally Well; New Century Nutrition; Nutrition & Healing; Nutrition Insight; Nutrition News (edited by Siri Khalsa); The Nutrition Reporter; Options; Organic Food News; People’s Medical Society Newsletter; Price-Pottenger Nutrition Foundation Health Journal; Prescriptions for Healthy Living; Pure Facts; Self Healing; What Doctors Don’t Tell You; Women’s Health Advocate; Your Good Health.
Magazines: Alive; Alternative Medicine Digest; American Journal of Natural Medicine; Better Nutrition for Today’s Living; Body and Soul; The Choice; Choices; Counselor; Delicious!; Digest of Alternative Medicine; Energy Times; Explore More!; Flex; Good Medicine; Health Counselor; Health Freedom News; Health Science; Health World; Healthier Times; HealthKeepers; Healthy & Natural; Healthy Living; Herbs for Health; Holistic Medicine; The Human Ecologist; Innovation; Journal of Longevity; Journal of Longevity Research; Let’s Live; Life Extension; Massage & BodyWork; Muscle & Fitness; Muscular Development; Natural Health; The Natural Way; New Age Journal; New Body; Newlife; Nutrition & Fitness; Nutritional Perspectives; Prevention; Prime Health & Fitness; Psychology Today; Search for Health; Senior Health; Total Health; Townsend Letter for Doctors and Patients; Vegetarian Times; Your Health. © 2010, Stephen Barrett, M.D.
FTC laws protect consumers against false and misleading advertising. Federal laws and some state food and drug laws provide protection against im- proper labeling of products and advertising with false or unproved health claims. However, many independent publications promote questionable products. Consumers
should be alert to this situation and be aware that mis- information about food supplements is spread through many channels (see Chapter 11). Bestseller lists often contain untrustworthy books on diet, fitness, or “alternative medicine.” For example, in recent years: (a) Deepak Chopra, M.D., has charmed the
Chapter Two Separating Fact from Fiction 25
public by declaring that health is a conscious choice; (b) Andrew Weil, M.D., has promoted many unsubstantiated methods; (c) Nicholas Perricone, M.D., has promoted the simplistic idea that inflammation is the cause of aging; and (d) the Public Broadcasting System has pro- moted The Perricone Prescription and Gary Null’s Ulti- mate Anti-Aging Diet for fundraising purposes. Amazon Books lists more than 1500 astrologic books written in English that are in print. Many of these involve health predictions. Many publishers are willing to publish books on unproven theories if they think that the books will be profitable. Only a few are unwilling to do so, and fewer still are willing to criticize dubious methods. Prometheus Books is the only one that regularly publishes books that attack quackery and paranormal claims. Radio and television. Thousands of radio and television stations provide a steady stream of health news and commentary. Many stations use physicians as commentators or consultants. Although news reports tend to be presented accurately, talk shows give frequent exposure to promoters of quack- ery, and infomercials are almost always misleading (see
Chapter 4). Talk-show guests are usually selected for their “entertainment” (audience-attracting) value rather than the soundness of their ideas. Some gain media ac- cess by hiring public relations firms to promote their media appearances. Critics of quackery are sometimes invited to debate, but are rarely permitted to appear unop- posed. Stations rarely take corrective action when they receive complaints about their health programming.62
Media outlets rarely criticize each other’s coverage of health and science topics. A notable exception was a Newsweek cover story describing in detail how Oprah Winfrey has promoted dubious and sometimes danger- ous health advice from Christiane Northrop, M.D., and actresses Suzanne Somers, Jennifer McCarthy, and a few others. Oprah’s talk shows sometimes pretend to provide balance, but science-based critics are never given enough time to counter the nonsense.63 Heussner and Salmon64 have noted three shortcom- ings of fallacious reporting: (1) many people may be led to doubt their doctors and acquire unrealistic hope in a risky procedure, (2) ensuing controversies can divert scientists’ valuable time and attention or cause scarce research funds to be wasted on studies to formally disprove an obviously unworthy proposition, and (3)
American Telemedicine Association Advisory on the Use of Medical Web Sites (1999)
Since the use of the Internet for accessing health information and medical treatment is new, there exists little in the way of safeguards for consumers. These guidelines can help consumers who choose to use the Internet to obtain information about health care or to seek medical treatment:
1. Make sure that Web sites used to obtain information about health and medicine are provided by a reliable and credible source, such as recognized and credentialed health-care providers, and use sources that are based on qualified authorities. The source of the information should be clearly labeled and annotated.
2. In some cases commercial interests such as a drug manufacturer may sponsor or contribute information to a Web site. Consumers should look for assurances that the information provided in these cases is objective and does not favor the sponsor’s products.
3. At this time consumers should exercise caution in using Web sites that offer online diagnosis of an individual’s medical condition and prescribed treatment and medi- cation for the diagnosed condition. There are currently no recognized accreditation or regulatory authorities overseeing the operation of these sites.
4. It is a widely recognized conflict of interest for health professionals who prescribe medicines to have any direct financial relationship with an entity that sells those medications. Therefore, consumers are cautioned against obtaining prescribed medicines from Web sites that offer both diagnosis of condition and direct sales of the prescribed medicine.
5. Consumers seeking medical treatment from health professionals over the Internet should receive clear as- surances that they will be interacting with a qualified professional holding the appropriate credentials and that the professional is able to legally practice medicine in the consumer’s location.
6. Clinical consultation over the Web by credentialed pro- viders should include procedures that protect the patient, including informed consent, information security and privacy protection measures, and documentation of the clinical encounter.
√ Consumer Tip
Part One Dynamics of the Health Marketplace26
fallacious reporting wastes media resources that could be better used to provide useful information about health and disease issues.
pruDent uSe oF tHe internet
The amount of health-related information accessible through the Internet is huge and expanding rapidly. Any- one with access to a computer, a modem, and appropriate software can explore this wealth of information. Students can do so, free of charge, through computers at their school. Free access is also available at public libraries. Health information is available in several electronic formats. Online databases can be searched by key- word. MEDLINE, the National Library of Medicine’s database of references to the medical literature, can be accessed through various commercial and noncommer- cial channels. It is the world’s largest such database, with more than 18 million references published since 1966 and about 14,000 new ones added per week. Newsgroups, bulletin boards, and “blogs” enable people to hold discussions by posting and responding to messages. “Chat groups” permit discussions with all participants typing at once. Electronic mailing lists en- able designated groups to hold discussions by electronic mail. Many Web sites offer free podcasts and e-mail newsletters. Online sources provide peer communica- tion, anonymity, convenience, and rapid responses. The information is voluminous but not necessarily accurate. Virtually anyone can create an online resource and make it generally available. This includes not only health professionals but also ordinary people who believe they have been helped by a product, people with complaints, companies with a financial stake in the information they provide, and even outright charlatans.
Locating Information The Internet has no central index, but the World Wide Web offers search engines that comb large portions of the Internet. The most efficient is Google (www.google. com), which can search billions of pages in about 1 second. Its advanced search page enables display of as many as 100 links at a time. The “Cached” links sometimes access pages archived on Google’s servers that are no longer on the Web. For most efficient use, it is advisable to save one’s preferences and add Google’s advanced search page to your personal toolbar. The Wayback Machine, located at www.archive.org, provides archived versions of many Web sites as they appeared as far back as 1996. MEDLINE can be searched efficiently with the
Signs of a Misguided Web Site
The best way to avoid being quacked is to reject quackery’s promoters. Each item listed below signi- fies that a Web site is not a trustworthy information source:
General Characteristics • Any site used to market herbs or dietary supple-
ments. Although some of these products are useful, it is impossible to sell them profitably without deception, which typically includes: (a) lack of full disclosure of relevant facts, (b) promotion or sale of products that lack a rational use, and/or (c) failure to state who should not use the products.
• Any site used to market or promote homeopathic products. No such products have been proven ef- fective.
• Any site that generally promotes “alternative” methods. There are more than 1000 “alternative” methods. The vast majority are worthless.
• Any site that promotes “nontoxic,” “natural,” or “holistic” treatments.
False Statements about Nutrition • Everyone should take vitamins. • Vitamins are effective against stress. • Taking vitamins makes people more energetic. • Organic foods are safer and/or more nutritious than
ordinary foods. • Losing weight is easy. • Special diets can cure cancer. • Diet is the principal cause of hyperactivity.
False Statements about “Alternative” Methods • Acupuncture is effective against a long list of
diseases. • Chelation therapy is an effective substitute for
bypass surgery. • Chiropractic treatment is effective against many
diseases. • Herbs are generally superior to prescription
drugs. • Homeopathic products are effective remedies. • Spines should be checked and adjusted regularly
by a chiropractor.
False Statements about Other Issues • Fluoridation is dangerous. • Standard vaccinations are dangerous. • Amalgam (“silver”) fillings should be removed
because they make people sick. • All teeth that have had root-canal therapy should
be removed because they make people sick.
√ Consumer Tip
Chapter Two Separating Fact from Fiction 27
National Center for Biology Information’s “Clinical Queries” page at www.ncbi.nlm.nih.gov:80/entrez/query/ static/clinical.html. It is generally much safer to use professionally recommended sites rather than searching blindly with a search engine. Slater and Zimmerman65 warn:
Listings of search results provided by the most widely used Web portals often do not provide basic information a consumer would need to select an objective and reliable health informa- tion Web site. Search descriptions of health sites ideally should permit consumers before actually accessing a Web site, to determine more consistently and accurately the source of the information and whether the site is selling products or provid- ing information free of commercial intent. Commercial sites are of particular concern given evidence that the large majority of such sites promote unregulated supplements and unproven remedies and services and that pseudoscientific claims made by such promotional sites may be persuasive even to readers with college-level scientific training.
Even MEDLINE searches have potentially serious shortcomings. Without expert guidance, it can be difficult or impossible to judge whether individual reports are significant and how to integrate them with other relevant information. Judging Credibility The following questions can help evaluate the credibility of an online information source: (a) Who maintains the information? (b) Is it linked with other reputable sources of medical information? (c) When was it last updated? and (d) Is it selling a product? Larkin and Douglas66 sug- gest that if you find something interesting, write it down (and the site’s location) and ask your doctor about it. Barrett67 recommends avoiding all sites that are market- ing dietary supplements, herbs, or homeopathic products. Unsolicited commercial e-mail messages (“spam”) for health-related products should also be ignored. Many efforts have been made to develop quality standards and rating systems.68 Two Canadian research- ers examined 47 systems used to rate Web sites providing health information on the Internet and found that 14 of these described their rating criteria, only 5 provided in- structions for their use, and none provided information on whether they had been validated. The researchers concluded:
Many incompletely developed instruments to evaluate health information exist on the Internet. It is unclear, however, whether they should exist in the first place, whether they measure what they claim to measure, or whether they lead to more good than harm.69
Each of these sites contains extensive practical information. However, some articles about “complementary” and “alternative” methods on the sites marked with an asterisk (*) are not sufficiently critical.
Academy of Nutrition and Dietetics www.eatright.org
American Academy of Family Physicians www.aafp.org/family/patient.html
American Academy of Pediatrics www.aap.org
American Cancer Society www.cancer.org
American Council on Science and Health www.acsh.org
American Heart Association www.americanheart.org
American Medical Association www.ama-assn.org
Consumer Reports Health www.consumerreportshealth.org
Federal Trade Commission www.ftc.gov
Food and Drug Administration www.fda.gov Center for Food Safety & Applied Nutrition vm.cfsan.fda.gov Information for Consumers www.fda.gov/opacom/morecons.html
Mayo Clinic Health Oasis* www.mayohealth.org
Merck Manual Home Edition* www.merckhomeedition.com
National Cancer Institute* www.nci.nih.gov
National Institutes of Health* www.nih.gov
Oncolink (cancer database) oncolink.upenn.edu
Quackwatch www.quackwatch.org
Science-Based Medicine http://www.sciencebasedmedicine.org
U.S. Preventive Services Task Force www.ahrq.gov/clinic/uspstfix.htm
Internet Health Pilot (www.ihealthpilot.org) provides a trustworthy guide to additional sites.
recommenDeD web SiteS Table 2-3
Part One Dynamics of the Health Marketplace28
Most of these rating systems excessively weighted ap- pearance, ease of use, and other factors unrelated to information quality.70 Most guides to health-related Web sites judge good sites accurately but fail to appropriately criticize bad ones. The HONcode system encourages voluntary compli- ance with high standards, but it does not ensure that con- tent is accurate. (See Consumer Health Insight box.)
Quackwatch’s screening list enables rapid identifi- cation of “quacky sites” to avoid. (See Consumer Tip box on page 27.) However, judging the accuracy of science-based sites requires expert knowledge. So even if a “perfect” yardstick were developed, no organization is likely to have sufficient resources to apply it to the huge number of sites available for laypersons. Table 2-3 lists the URLs of several reliable sources.
Consumer Health Insight
Significance of the HONcode Seal
The Internet’s most widely recognized standard-setting organization for health information is the Geneva- based Health on the Net (HON) Foundation (www.hon.ch). Sites that follow its code of conduct are welcome to display the HONcode seal. The HONcode’s eight principles, listed below, evolved from discussions with Webmasters and medical professionals in several countries. These principles are sound, but compliance is voluntary and some sites displaying the seal contain unreliable information or link to other sites that contain unreliable information. To legitimately use the seal, a Web site must apply for registration. If
accepted, it must subsequently comply with all the principles enumerated in the HONcode. When a noncompliant site is reported, HONcode officials ask that the seal be removed—and most sites comply. More than 5000 sites display the HONcode seal. To check whether a site is actually registered, click on the seal, which should be linked to a registration status report on the HON site. The HON Foundation also reviews Web sites and posts the results. However, its reviews of sites providing unreliable information on “alternative” methods have been descriptive rather than critical—and thus offer little or no guidance to Web browsers. In addition, its search engine does not limit its searches to reliable sites. HON officials are aware of these problems and have indicated interest in correcting them. Quackwatch has identified several HONcode violators.71
1. Authority Any medical or health advice provided and hosted on
this site will only be given by medically trained and qualified professionals unless a clear statement is made that a piece of advice offered is from a non-medically qualified individual or organization.
2. Complementarity The information provided on this site is designed to
support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician.
3. Confidentiality Confidentiality of data relating to individual patients
and visitors to a medical/health Web site, including their identity, is respected by this Web site. The Web site owners undertake to honor or exceed the legal re- quirements of medical/health information privacy that apply in the country and state where the Web site and mirror sites are located.
4. Attribution Where appropriate, information contained on this site
will be supported by clear references to source data and, where possible, have specific HTML links to those data. The date when a clinical page was last modified will be clearly displayed (e.g., at the bottom of the page).
5. Justifiability Any claims relating to the benefits/performance of a
specific treatment, commercial product or service will be supported by appropriate, balanced evidence in the manner outlined in Principle 4.
6. Transparency of authorship The designers of this Web site will seek to provide
information in the clearest possible manner and pro- vide contact addresses for visitors who seek further information or support. The Webmaster will display his/her e-mail address clearly throughout the Web site.
7. Transparency of sponsorship Support for this Web site will be clearly identified,
including the identities of commercial and non-com- mercial organizations that have contributed funding, services, or material for the site.
8. Honesty in advertising and editorial policy If advertising is a source of funding, it will be clearly
stated. A brief description of the advertising policy adopted by the Web site owners will be displayed on the site. Advertising and other promotional material will be presented to viewers in a manner and context that facilitates differentiation between it and the original material created by the institution operating the site.
Chapter Two Separating Fact from Fiction 29
FurtHer SuggeStionS For conSumerS
Individuals must act intelligently to protect themselves from misleading and fraudulent practices that abound in the health marketplace. It is especially helpful to use “information anchors”—impeccable information sources that provide basic guidance about what is trustworthy and what is not. Johnson and Goldfinger72 provide these tips for evaluating medical or health information:
• Reports should be based on studies published in peer- reviewed medical journals.
• Proof that a new treatment is effective requires controlled studies that compare treatment under discussion to other treatments or to no treatment. Controls help to remove bias, and with large enough numbers the study can be statistically valid.
• Safety is not an absolute phenomenon but a relative one. All life activities, including medical treatment, involve some risk. The question is whether the risk is justified in comparison to other treatments and to the potential gain.
• Be wary of claims of unusual remedies for chronic or in- curable diseases. The burden of proof rests with those who make the claims.
Fleiger73 advises consumers to be skeptical of news of major drug “breakthroughs” because many such reports are exaggerated or inaccurate interpretations of scientific findings. Noting that truly significant advances in drugs and drug therapy are rare, he gives these tips: • News stories about drugs producing complete cures, es-
pecially in patients with severe arthritis, AIDS, cancer, or other grave illnesses, are likely to be wrong. Except for antibiotics, few drugs can make a disease disappear totally and permanently.
• The results of one study of a small number of patients are seldom, if ever, conclusive. News stories may place undue importance on these reports and jump to conclusions that the researchers themselves know are unjustified.
• Consider whether the report was made by a reporter or news service that regularly covers health and medical affairs and assigns reporters specializing in the subject. Be skeptical if the source emphasizes sensational stories regularly.
• Ask your doctor. Although physicians cannot know every- thing, they are likely to be aware of truly important medical advances.
To stay informed, consumers can do the following:
• Read reliable publications such as those recommended in Table 2-2. The best newsletters are Consumer Reports on Health, Tufts University Health & Nutrition Letter, and University of California at Berkeley Wellness Letter.
• Identify and use trustworthy sources of information on the Internet.
• Read Consumer Health Digest, a free e-mail newsletter that provides news related to the topics covered in this textbook. Subscription information is at www.quackwatch. org/00AboutQuackwatch/chd.html.
• Select health professionals and health educators carefully.
• Obtain information from federal, state, and local govern- ment agencies and reputable professional and voluntary organizations, such as the FDA, the AMA, the American Cancer Society, the American Dental Association, the U.S. Public Health Service, and others listed in the Appendix.
• For breaking health and medical news, read such sources as Time, Newsweek, U.S. News & World Report, The New
How to Judge an Information Source The following questions may be helpful in determining reliable sources of information:
• What is the purpose of the book, presentation, or statement? Is it to sell products or ideas and make money? Or is it to present data or to make a profes- sional contribution?
• What is the procedure and style of presentation? Is it presented in an educational or scientific manner? Are propaganda devices used, such as testimonials, broad generalities, name-calling, and misleading statements? Does the information contain exagger- ated claims or use gross superlatives?
• What are the qualifications of the author, speaker, organization, or agency? What is the educational background, professional experience, and training of the individual? If he or she has scientific credentials, are they in the field in which the claims are made?
• What is the standing of the individual in the profes- sional community? Is the person listed in any rec- ognized biographic sources such as American Men and Women of Science or in directories of health specialists?
• Are the data based on appropriate research by experts in the health field or on the testimony or opinions of one or a few individuals? Is the information based on scientific facts or on emotional appeal?
• Has the information been published in peer-reviewed professional journals and generally accepted as valid by the scientific community? If not, find out who disagrees with it and why.
• Where there appear to be conflicting claims about a health matter, what is the extent of the evidence supporting or refuting the claims? Has the claimant generalized from a particular incident or from broad research?
√ Consumer Tip
Part One Dynamics of the Health Marketplace30
According to a local newspaper report, a researcher at a medical center claims to have discovered a substance that shows great promise for curing severe acne. How can consumers determine whether the report is valid? What questions should be raised about the research methodology, the use or misuse of statistics, the possibility of fraud, and whether the study has been peer-reviewed? How can the reliability of this information be checked?
It’s Your DecisionYork Times, and The Wall Street Journal, but be cautious about their coverage of “alternative” health methods and alleged health threats.
• Take courses at accredited schools, but do not assume that all their courses are free of misinformation.
SummarY
Consumers obtain health information from nonprofes- sional, professional, and pseudoprofessional individuals as well as from educational institutions and the media. Unfortunately, much of this information is misleading, inaccurate, or false. Scientific methods offer an objective way to evaluate information to determine what is false, but even scientists sometimes find it difficult to sort fact from fiction. The intelligent health consumer should:
• Maintain a healthy degree of skepticism toward health information received through the media.
• Select practitioners with great care. • Become well-informed before making decisions to purchase
and use health products and services; pay little or no atten- tion to health advertising.
• Seek trustworthy sources of information. • Be familiar with the fundamental concepts used in the
scientific method, including statistical concepts. reFerenceS
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Chapter Two Separating Fact from Fiction 31
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Part One Dynamics of the Health Marketplace32
Frauds and Quackery
There is nothing men will not do . . . to recover their health and save their lives. They have submitted to being half-drowned in water, and half-choked with gases, to being buried up to their chins in earth, to being scarred with hot irons like galley slaves, to being crimped with knives like codfish, to having needles thrust into their flesh, and bonfires kindled in their skins, to swallowing all sorts of abominations, and to pay for all this, as if to be singed and scalded were a costly privilege, as if blistering were a blessing and leeches a luxury. oliver wendell holmes
The most outrageous lies that can be invented will find believers if a man only tells them with all his might.
mark twain
There’s a sucker born every minute. often attributed to p.t. barnum
There’s also a crook born every hour who can take care of sixty suckers. anonymous
Chapter Three
© 1
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Quackery stands in science’s shadow. Most effective remedies have a bogus counterpart.
Part One Dynamics of the Health Marketplace34
• Anecdotes and testimonials are not trustworthy evidence that a product or service is effective.
• Spontaneous remissions and the placebo effect can make it difficult to determine whether treatments are effective.
• Quackery is far more widespread and pervasive than most people realize.
• The best way to avoid being tricked is to stay away from tricksters. Don’t base your health-related decisions on the advice of people who exhibit the signs of quackery described in this book.
• Many quacks try to divert attention from the worthlessness of their methods by using deceptive language, promoting conspiracy theories, and talking about “freedom of choice.”
keep These poinTs in Mind as you sTudy This chapTer
Key Concepts
D espite the tremendous advances in medical sci- ence, health frauds and quackery are still com- mon. Newspapers, magazines, radio, television,
and the Internet provide entrepreneurs with enormous opportunities to promote their wares to the public. Laws intended to control fraud and quackery have not been particularly successful. This chapter provides practical definitions of health fraud and quackery, explains why people are vulnerable, and tells how to identify and avoid quack practices. Many other chapters provide detailed information and examples of quackery’s harmful impact on individuals and society. Antiquackery organizations and activities are described in Chapter 25.
deFiniTions
“Quackery” derives from the word quacksalver (some- one who boasts about his salves). Dictionaries define quack as “a pretender to medical skill; a charlatan” and “one who talks pretentiously without sound knowledge of the subject discussed.” These definitions suggest that the promotion of quackery involves deliberate deception, but many promoters sincerely believe in what they are doing. The U.S. Food and Drug Administration (FDA) defines health fraud as “the promotion, for profit, of a medical remedy known to be false or unproven.” This can cause confusion because in ordinary usage—and in the courts—the word “fraud” connotes deliberate decep- tion. Moreover, unproven methods are not necessarily quackery. Those that are consistent with established scientific concepts and are under clinical investigation may be considered legitimately experimental. Dr. William T. Jarvis,1 former president of the National Council Against Health Fraud, stresses that quackery’s paramount characteristic is promotion rather than fraud, greed, or misinformation.
Ethical researchers and practitioners do not promote unproven procedures in the marketplace but engage in responsible studies with proper protocols (see Chapter 2). They may try methods that have not been completely tested, but they should not peddle them to build their practice. Methods not compatible with established sci- entific concepts should be classified as nonsensical or disproven rather than experimental. Homeopathy’s claim that infinitesimally dilute solutions can exert powerful effects is the epitome of health nonsense (see Chapter 8). Promoters of quackery often use euphemisms like “alternative” and “holistic” to describe their methods. However, the terms unscientific, nonscientific, pseudo- scientific, or dubious are more appropriate. This book generally uses these terms and places the word “alter- native” in quotation marks when using it to describe
Quacks Quack! Why should a critter as cute and harmless-looking as a duck be used to symbolize the vicious social menace of quackery? A vulture would seem to be more appropri- ate. But vultures actually wait until death occurs before engaging their targets. Thus their conduct is too benign to symbolize quackery, which preys on the weak, the helpless, and the desperate. Other birds of prey behave more like that of quacks, but the bald eagle, which is a national symbol, would not be suitable for derision. An ostrich might be ap- propriate, because of its reputation for hiding its head in the sand, thus symbolizing the denial so often seen in both quacks and their victims. The word quack is short for “quacksalver,” which literally means to quack like a duck about one’s salves. The duck personifies quackery because it makes a lot of noise about nothing. William T. Jarvis, Ph.D.
Historical Perspective
Chapter Three Frauds and Quackery 35
unscientific methods. Chapter 8 describes how some methods are labeled “complementary” or “integrative” to make them seem more respectable. Most people think of quackery as something pro- moted by charlatans who deliberately exploit their victims. Actually, most promoters are unwitting victims who share misinformation and personal experiences with others. Customers of multilevel companies that sell health-related products typically have been persuaded by friends, relatives, and neighbors who use the products because they believe that they are effective. Pharmacists profit from the sale of nutrition supplements that few customers need. In most cases pharmacists do not cham- pion the products but simply profit from the misleading promotions of others.
Much quackery involves telling people something is bad for them (such as food additives) and selling a substitute (such as “organic” or “natural” food). Quack- ery is also involved in misleading advertising of dietary supplements, herbal and homeopathic products, and some nonprescription drugs. In many such instances no individual “quack” is involved—just deception by manufacturers and their advertising agencies. Quackery is not an all-or-nothing phenomenon. A practitioner may be scientific in many respects and only minimally involved in unscientific practices. Also, prod- ucts can be useful for some purposes but worthless for others. For example, vitamin B12 shots are lifesaving in cases of pernicious anemia, but giving them frequently to “pep you up” is quackery. Quackery and malpractice overlap but are not identical. Quackery entails the use of methods that are not scientifically accepted. Malpractice involves failure by a health professional to meet accepted standards of diagnosis and treatment. It includes situations in which the practitioner was negligent while using standard meth- ods of care. Leaving a surgical instrument in a patient’s abdomen or operating on the wrong part of the body are examples of malpractice that are unrelated to quackery. To avoid semantic problems, some experts suggest that quackery be broadly defined as “anything involving overpromotion in the field of health.” This definition would include questionable ideas as well as question- able products and services, regardless of the sincerity of their promoters. In line with this definition, the word “fraud” would be reserved only for situations in which deliberate deception is involved.
scope
Many billions of dollars are spent yearly on products and services that are falsely claimed to prevent or alleviate health problems. Billions are wasted annually for “al- ternative” treatments, spurious food remedies, weight- reduction schemes and products, fad diets, “organic” and “natural” foods, and unnecessary vitamins and minerals (see Chapters 10 and 11). Billions more are wasted on exercise equipment (see Chapter 13), worthless and possibly harmful cancer remedies (Chapter 16), unneces- sary and ineffective drug and beauty products (Chapters 17 and 18), and magnets and other health devices (see Chapter 20). However, no reliable figures exist on the total amount spent on quackery each year The California Medical Association3 has listed the following widely promoted modalities as questionable: acupuncture, acupressure, applied kinesiology, bogus
Defrauding the Desperate2
Gregory Earl Caplinger (1953–2009) claimed to be a distinguished and widely published medical doctor and researcher. However, his “medical degree” and many of his other “credentials” came from diploma mills or sources he himself invented. For several years Caplinger operated a clinic in the Dominican Republic that offered treatment to desperate patients. In 1999 he victimized a 60-year-old woman who had undergone surgical treatment for colon cancer. Although follow-up tests had found no evidence of can- cer, she contacted Caplinger because she thought that a nonstandard treatment might boost her immune system to reduce the odds of recurrence. Caplinger persuaded her to come by stating that a small nabothian cyst men- tioned in an ultrasound report “could go either way” and therefore required immediate treatment. The estimated cost was $80,000 to $90,000, with a $40,000 advance deposit. Terrified that the cyst could become malignant, she mortgaged her home, wired the deposit, and went for treatment. Nabothian cysts are plugged glands on the uterine cervix that pose no health threat and have nothing whatsoever to do with cancer. Shortly after she arrived at Caplinger’s clinic, her husband read an article on the Quackwatch Web site exposing Caplinger as a fraud. She demanded a refund but got back only $20,000. A few months later, Caplinger was indicted on charges of wire fraud and money laundering related to investments in his bogus remedy. He was convicted in July 2000 but did not show up to hear the verdict and became a fugitive wanted by the FBI. In 2001 he was apprehended, sentenced to 14 years in prison, and ordered to repay more than $1 million to his victims.
Personal Glimpse
Part One Dynamics of the Health Marketplace36
arthritis treatments, “cellular therapy,” cellulite removal, chelation therapy, clinical ecology, colonic irrigation, cytotoxic testing, DMSO (dimethyl sulfoxide), enzymes and “glandular extracts,” faith and psychic healing, figure enhancers, hair analysis, homeopathy, immune system protectors, iridology, Laetrile (amygdalin) treat- ment for cancer, live cell analysis, nutrition remedies for cancer, polarity therapy, reflexology, Touch for Health, vitamin megadoses, and youth prolongers. A 1984 Congressional subcommittee report4 detailed numerous fraudulent and quack endeavors including: (a) clinics inside and outside the United States that provided bogus treatments for chronic and terminally ill patients using diet, drugs, and enemas for arthritis, cancer, heart disease, and other ailments; (b) foundations that encour- aged the use of unproven remedies; and (c) phony healers who used a religious healing image or claimed to have powers generated by Satan or witchcraft. In 1989 the FDA5 listed the following as the top 10 health frauds: (a) fraudulent arthritis products, (b) bogus AIDS cures, (c) instant weight-loss schemes, (d) fraudulent sexual aids, (e) spurious cancer clinics, (f) quack baldness remedies and other appearance modifiers, (g) false nutritional schemes, (h) unproven use of muscle stimulators, (i) chelation therapy (claimed to clean out clogged arteries), and (j) treatment for nonexistent yeast infections.
VulnerabiliTy
Despite the advanced state of medical science, many people with health problems turn to dubious methods. Faced with the prospect of chronic suffering, deformity, or death, many individuals are tempted to try anything that offers relief or hope. The terminally ill, the elderly, and various cultural minorities are especially vulnerable to health frauds and quackery. Many intelligent and well- educated individuals resort to outlandish procedures with the belief that anything is better than nothing. Former Arthritis Foundation official Jerry Walsh, who was stricken at age 18 with rheumatoid arthritis, admitted that during the early years of his illness he spent thousands of dollars on quack remedies—everything from radium gadgets to magic buckeyes. Beyerstein6 has noted:
Subtle forces can lead intelligent people (both patients and therapists) to think that a treatment has helped someone when it has not. This is true for new treatments in scientific medicine, as well as for nostrums in folk medicine, fringe practices in “alternative medicine,” and the ministrations of faith healers.
Specific reasons why people turn to questionable methods include the following:
• Individuals may underestimate the degree of illness or believe they cannot afford standard care.
• Religious and cultural beliefs can foster acceptance of faith healers, prayer, magic, sorcery, and the like. For example, some Chinese people consider acupuncture and herbal remedies as standard forms of treatment and regard the scientific medicine practiced in the United States as totally foreign.
• Physicians may be unable to communicate in an effective manner so that their patients understand. Patients may be unable to question their physicians; they may lack knowl- edge or fear that they will be criticized.
• Patients may distrust physicians or question the quality of their care. Doctors sometimes appear more concerned with treating illnesses than with helping the patient.
• Some people harbor extreme distrust of the medical profes- sion, the food industry, drug companies, and government agencies. Some feel deeply antagonistic toward scientific medicine but are attracted to methods that are “natural” or otherwise unconventional.
• People fear social unacceptability, pain, death, and growing old (wrinkles, loss of hair and sensory acuity, decreased sexual potency, and incontinence). Elderly individuals are particularly vulnerable in this regard.
• Faced with a serious health problem that physicians can- not solve, many people become desperate enough to try almost anything that arouses hope. Many patients with cancer, arthritis, multiple sclerosis, and AIDS fall prey to unscrupulous entrepreneurs. Some squander their life’s savings searching for a “cure.”
• Many people suffer from chronic aches, pains, or other discomforts for which medicine cannot offer clear-cut diagnoses or effective treatment. The more persistent the condition, the more susceptible the sufferer may be to promises of a “cure.” Many people in this category fall into the hands of doctors who make fad diagnoses such as hypoglycemia, “candidiasis hypersensitivity,” or “multiple chemical sensitivity” (see Chapter 8).
• Many practitioners have difficulty in helping people whose symptoms are the result of emotional problems or are bodily responses to stress.
• Many people are gullible because of their ignorance of health matters. People also tend to believe what others tell them about personal experience. Many people believe that any health-related claim in print or in a broadcast must be true, and many are attracted by promises of quick, painless, or drugless solutions to problems.
• The mass media provide much false and misleading infor- mation via advertisements, news reports, feature articles, books, radio and television programs, and the Internet. News reports are often sensationalized, stimulating false hopes and arousing widespread fears. Many radio and television producers who promote unsubstantiated health
Chapter Three Frauds and Quackery 37
claims say they are providing entertainment and have no ethical duty to check the claims.
• People fail to realize that some serious illnesses (even cancer and arthritis) have ups and downs. Temporary improvement may be mistakenly attributed to whatever product or service was used before it occurred.
• Many people do not understand the nature of the placebo effect (discussed later in this chapter).
• Self-confidence, which quacks tend to exude, is a powerful persuader. The “Self-Confidence Sells” Personal Glimpse box contains the condensed testimony of a defense witness in the 1990 trial of a Canadian couple whose infant daughter had died of malnutrition under the care of an unlicensed naturopath. The couple were charged with criminal negli- gence, but they were acquitted when a judge ruled that the problem was not neglect but misplaced trust.
Psychologist Anthony R. Pratkanis, Ph.D.7, has iden- tified nine strategies used to sell pseudoscientific beliefs and practices. They include setting phantom goals (such as better health, peace of mind, or improved sex life), making statements that tend to inspire trust (“supported by over 100 studies”), and fostering granfalloons (proud and otherwise meaningless associations of people who share rituals, beliefs, jargon, goals, feelings, specialized information, and “enemies”). Multilevel sales groups, nutrition cultists, and crusaders for “alternative” treat- ments fit this description well.
hazards
Consumers should be aware of quackery’s dangers. Financial harm can range from minor expense to loss of one’s life savings. Improper diagnosis can lead to a deterioration of health. Unsafe procedures and delay in getting proper treatment can have serious or fatal consequences. Psychologic harm can also occur.8 The following well-publicized cases illustrate quackery’s serious potential for harm. In 1961, the parents of 8-year-old Linda Epping charged that a chiropractor had bilked them out of $739 by promising to cure her of cancer of the eye. Linda had been scheduled for surgery to remove her left eye and surrounding tissue. Her doctors thought cure was pos- sible because it appeared that the tumor had not spread. But shortly before the operation was to be performed, Linda’s parents met a couple who said that a chiropractor had cured their son’s brain tumor without using surgery. After the chiropractor agreed to help by “balancing” Linda’s body, her parents removed her from the hospital and took her for treatment with “spinal adjustments,” vitamins, food supplements, and laxatives (up to 124 pills plus 150 drops of iodine solution daily). Despite the
Self-Confidence Sells The herbalist was a very impressive man. He just glowed with health and was very charismatic, very jovial, charming, friendly, very nice, very knowledgeable. There was not a question that you could ask that he would not have an answer for. And he told a lot of stories about people who had come to see him and been cured by following his course of treatment. It’s a very difficult thing to communicate just how mesmerizing this man was. He was so good, so positive. He just exuded this powerful aura about him. He told my father that his cancer was completely curable. He had to change his diet because this was the cause of the cancer. He would have to eat strictly fruits and vegetables, raw, or juices of those fruits and vegetables, and by doing this, the tumor would be dissolved. When my father lost weight, the herbalist said this was just the body ridding itself of toxins and poisons. During his final two weeks, my father developed a hole near his rectum and a lesion that grew bigger each day. The herbalist said it was just the radiation coming out, which was a good thing. I now know it was a gangrenous tumor. I look back now and can’t believe that I fell under this man’s spell. Testimony of Magaly Bianchini11
Personal Glimpse
new “treatment,” the tumor grew quickly. Within three weeks it was the size of a tennis ball and had pushed Linda’s eye out of its socket. She died within a few months. The chiropractor was subsequently convicted of second-degree murder and sentenced to prison.9 Ruth Conrad, an Idaho woman, consulted one of the state’s many unlicensed naturopaths. While seeking treatment for a sore shoulder, she also complained of a bump on her nose. The naturopath stated that it was cancer and gave her a black herbal salve to apply di- rectly. Within a few days, her face became very painful and she developed red streaks that ran down her cheeks. Her anxious phone call to the naturopath brought the explanation that the presence of the lines was a good sign because they “resemble a crab, and cancer is a crab.” He also advised her to apply more of the black salve. Within 1 week, a large part of her face, including her nose, sloughed off. It took 3 years and 17 plastic surgery operations to reconstruct her face. Caroline Copeland,10 an Arizona journalist, con- sulted a leading “holistic” physician who seemed very attentive to her concerns. During most of the 16 years she remained under his care, his recommendations ap- peared logical and effective. Her initial diagnosis was
Part One Dynamics of the Health Marketplace38
hypoglycemia (low blood sugar). Later she was told she had hypothyroidism and was treated with thyroid hormone. Then she developed a “stubborn case” of iron-deficiency anemia that was treated with very high oral doses of iron and several vitamins plus injections containing iron, liver extract, and vitamin B12. She also developed persistent constipation with bouts of ab- dominal pain. When additional symptoms developed, she sought help elsewhere and learned that all of the previous diagnoses had been wrong and that her symp- toms were caused by iron and vitamin poisoning, thyroid hormone overdose, a grapefruit-sized ovarian cyst, and endometriosis (which, undiagnosed, had prevented her from bearing children). When she complained, the state licensing board concluded that her care had been inadequate, but it permitted the doctor to remain in practice.
coMMon MisconcepTions
There are many misconceptions about quackery. The following are among those identified by Jarvis and Barrett12: Quacks are frauds and crooks. Most promoters of quackery sincerely believe in what they do. Their decep- tion of others may not be deliberate. Most quackery is dangerous. Most victims of quack- ery are harmed economically rather than physically. Sometimes a bogus approach will relieve emotionally related symptoms by lowering a person’s tension level. Although such an experience is likely to be perceived as beneficial, it can prove harmful in the long run if the individual decides to rely on unproven approaches for future health problems. The media are reliable. Most media are willing to publicize sensational viewpoints they believe are news- worthy and likely to increase their audience. Radio and television talk shows abound with promoters of nutri- tion quackery. General magazines that carry vitamin ads almost never publish articles advising readers not to waste their money on vitamins. Personal experience is the best way to tell whether a treatment works. When someone feels better after using a product or procedure, it is natural to credit whatever was done. However, this is unwise. Most ailments are self-limiting, and even incurable conditions can have sufficient day-to-day variation to enable quack methods to gain large followings. Taking action often produces temporary relief of symptoms (a placebo effect). In addition, many products and services exert physical or psychologic effects that users misinterpret as evidence that their problem is being cured. These “Dr. Feelgood”
modalities include pharmacologically active herbal products, quack formulas adulterated with prescription drugs, colonic irrigations (which some people enjoy), bodywork, and meditation. Scientific experimentation is almost always necessary to establish whether health methods are really effective. Thus it is extremely im- portant for consumers to understand the concepts of spontaneous remission and the placebo effect. Spontaneous Remission Recovery from illness, whether it follows self-medica- tion, treatment by a scientific practitioner, or treatment by an unscientific practitioner, may lead individuals to conclude that the treatment received was the cause of the return to good health. Medical historian James Harvey Young, Ph.D.,14 has noted:
John Doe does not usually realize that most ailments are self- limiting and improve with time regardless of treatment. When a symptom goes away after he doses himself with a remedy, he is likely to credit the remedy with curing him. He does not realize that he would have gotten better just as quickly if he had done nothing! Thousands of well-meaning John and Jane Does have boosted the fame of folk remedies and have
Personal Glimpse
A Traumatic Experience
In The Faith Healers, James Randi tells what happened to a youngster with twisted legs who attended televan- gelist Peter Popoff’s “Miracle Crusade” with strong expectations that he would be made well:
Following the . . . spectacle, I saw that little boy outside the Civic Center again, perched on his crutches and staring down at the pavement. At the service, the highly touted “healer” had not even come near the kid. . . . The boy looked up as I approached him. His smile was gone, and I saw tears running down his face. His eyes were red from weeping. I began to speak, intending to ask him what he now thought of Popoff and his promises. But I choked up and had to turn away. . . . I will never forget that terrible moment, as the child realized that he had witnessed a cruel cal- lous hoax. Hundreds of people at that meeting had believed they would see miracles performed. . . . Some few had been touched by the preacher, but none had been healed. Most had given cash or checks, some in envelopes sent to them by mail before they attended. One way or another, they were all swindled.13
Chapter Three Frauds and Quackery 39
signed sincere testimonials for patent medicines, crediting them instead of the body’s recuperative power for a return to well-being. . . . The unscientific healer does not need to observe the restraints of reputable medicine. Where true medical science is complex, the quack can oversimplify. . . . Where ailments are self-limiting, the quack makes nature his secret ally.
It is commonly said that if you treat a cold it will disappear in a week, but if you leave it alone it will last 7 days. Even many serious diseases have ups and downs. Rheumatoid arthritis and multiple sclerosis are prime examples. On rare occasions even cancer can inexpli- cably disappear (although most testimonials for quack cancer remedies are based on faulty original diagnosis or concurrent administration of effective treatment). Quackery’s victims are not the only ones who can be fooled by the placebo effect, spontaneous remissions, and other coincidental events. The gratitude and adula- tion of people who think they have been helped can even persuade charlatans that their methods are effective!
Placebo Effect You must know that the will is a powerful adjuvant of medicine. — paracelsus
The power of suggestion has been demonstrated by many investigators in a variety of settings. In a classroom, for example, a professor sprayed plain water about the room and asked the students to raise their hands as soon as they detected an odor. Seventy-three percent managed to smell a nonexistent odor.
Persons with a dominant or persuasive personality often have considerable impact on others through their ability to create confidence, which enhances suggest- ibility. Many individuals who are taken in by a charlatan later tell their doctors, “But he talked to me; he explained things; he was so nice.” Individuals who are psychologically susceptible to suggestion often feel better under the influence of counseling or reassurance. One woman remarked, “I take a multivitamin pill that Consumer Reports says is useless. But I don’t care. It makes me happy.” Gullibility and wishful thinking are common human characteristics. People are willing to believe in untrue things in varying ways and to varying degrees. Even scientifically sophisti- cated people may respond to the power of suggestion. In medicine the effect of suggestion is referred to as the “placebo effect” (Table 3-1). The Latin word placebo means “I shall please.” A placebo effect is a beneficial response to a substance, device, or procedure that cannot be accounted for on the basis of pharmacologic or other direct physical action. Feeling better when the physician walks into the room is a common example. A placebo may be used in medicine to satisfy a pa- tient that something is being done. By lessening anxiety, placebo action may alleviate symptoms caused by the body’s reaction to tension (psychosomatic symptoms). In certain circumstances a lactose tablet (sugar pill) may relieve not only anxiety but also pain, nausea, vomiting, palpitations, shortness of breath, and other symptoms. The patient expects the “medication” to cause improve- ment, and sometimes it does.
placebo MyThs and FacTs
Table 3-1
Myths 1. Placebos work on the imagination, not the body.
2. Placebos may help, but they cannot hurt.
3. Placebos work primarily on suggest- ible patients.
4. The patient must believe in the treat- ment for it to have a placebo effect.
5. Placebo response is not so important if the active drug really works.
6. Placebo response depends on the patient, not the practitioner.
Facts 1. Placebos affect people physiologically as well as psychologically. Emotions can trigger the release of hormones that can affect bodily functions in many ways.
2. Adverse reactions can occur. Common complaints include dry mouth, nausea, headache, drowsiness, sleep disturbance, and rash.
3. All kinds of people may respond. There does not appear to be a spe- cific personality profile.
4. Nonbelievers can experience placebo effects if they believe in the practitioner, are influenced by the setting, or are suggestible, even if they do not believe in the treatment.
5. Patients often respond to placebos as well as to active drugs; a pla- cebo can make an active drug more effective.
6. How the placebo is given and by whom can influence the outcome. However, it is not possible to characterize who will respond.
Part One Dynamics of the Health Marketplace40
Many studies have shown that placebos may relieve a broad range of symptoms. However, they do not cure disease. The psychologic aspects of many disorders also work to the healer’s advantage. A large percentage of symptoms either have a psychologic component or do not arise from organic disease. Hence, treatment offering some lessening of tension can often help. A sympathetic ear or reassurance that no serious disease is involved may prove therapeutic by itself. Beyerstein15 has observed:
Pain is partly a sensation . . . and partly an emotion. . . . Any- thing that can allay anxiety, redirect attention, reduce arousal, foster a sense of control, or lead to . . . reinterpretation of symptoms can alleviate the agony component of pain. Modern pain clinics put these strategies to use every day. Successful quacks and faith healers typically have charismatic personali- ties that make them adept at influencing these psychological variables that can modulate pain. . . . But we must be careful that purely symptomatic relief does not divert people from proven remedies until it is too late for them to be effective.
Confidence in the treatment—on the part of the patient and the practitioner—makes it more likely that a placebo effect will occur. But the power of suggestion may cause even a nonbeliever to respond favorably. The only requirement for a placebo effect is the awareness that something has been done. It is not possible to predict accurately or easily a particular patient’s reaction to a placebo at a particular moment. However, the psycho- logic predisposition to respond positively to placebos is present to some extent in most people. Some are very likely to obtain relief from placebos in a wide variety of situations, whereas others are very unlikely to do so. Most people’s response lies somewhere in between. Another factor that can mislead people is selective affirmation—a tendency to look for positive responses when improvement is expected. As Jarvis16 has noted: A culturally significant setting can also produce a potent ef- fect, as folk healers know well. Effective settings can be as divergent as the trappings of an oriental herb shop to Asians, a circle of witchcraft paraphernalia to a primitive tribesman, or the atmosphere of a modern clinic to a modern urban American. Social expectations can also play a role, as occurs in stoic cultures where people are taught to endure pain and suffering without complaining. . . . Operant conditioning can occur . . . when behavior is rewarded. . . . Thus, people with a history of favorable re- sponses to treatment are more apt to react well to the act of treatment.
Responses to the treatment setting can also be negative (“nocebo effects”). In one experiment, for example, some subjects who were warned of possible
side effects of a drug were given injections of a placebo instead. Many of them reported dizziness, nausea, vomit- ing, and even mental depression. A 1993 study of 109 double-blind drug trials found that the overall incidence of adverse events in healthy volunteers during placebo administration was 19%.17
Placebo responses, such as feeling less pain or more energy, can occur without affecting the actual course of the disease. Thus placebo responses can obscure real disease, which can lead to delay in obtaining appropriate diagnosis or treatment. The placebo effect is not limited to drugs but may also result from procedures.18 Devices and physical techniques often have a tremendous psychologic impact. Chiropractors, naturopaths, and various other nonmedi- cal practitioners use heat, light, diathermy, hydrotherapy, manipulation, massage, and a variety of gadgets. In addi- tion to producing physiologic effects, their use can exert a potent psychologic force that may be reinforced by the relationship between the patient and the practitioner. Of course, devices and procedures used by scientific practitioners can also have placebo effects. Barrett19 has expressed serious misgivings about over-reliance on the placebo effect in clinical practice:
Doctors are confronted by many people who complain of tiredness or a variety of vague symptoms that are reactions to nervous tension. Far too often, instead of finding out what is bothering them, doctors tell them to take a tonic, a vitamin, or some other type of placebo. Quacks who rely on the placebo effect pretend that (a) they know what they are doing, (b) they can tell what is wrong with you, and (c) their treatment is effective for just about ev- erything. Many of their patients play the equivalent of Russian roulette. Medical doctors who use vitamins as placebos may not be as dangerous, but they encourage people to habitually use products they don’t need. Because most people who use placebos do not get relief from them, their use is also a finan- cial rip-off.
Canter20 has added:
Deliberate use of placebos is resisted by doctors because it involves deceit. It is also paternalistic and inconsistent with treatment with informed consent. Nor can it be squared with a holistic and respectful approach to patients that treats them as intelligent and active participants in their own pursuit of health and well-being. If the placebo effect accompanies any therapeutic intervention, then the logical and ethical course of action is to choose treatments where there is a demonstrable specific effect, and to take steps to maximize the accompany- ing placebo response.
In many disorders, one-third or more of patients who receive a placebo will report improvement. How- ever, most placebo-controlled trials compare the active
Chapter Three Frauds and Quackery 41
treatment with a placebo, not with no treatment. This design cannot distinguish an effect of placebo from the natural course of the disease, regression to the mean (the tendency for very high or low test results to be followed by results closer to the average), or the effects of other factors. An analysis of 114 randomized trials that had a “no-treatment” group in addition to active treatment and placebo groups concluded that some of the reported benefit attributed to placebos might have resulted from patients wishing to please their doctors. The study’s au- thors also concluded that there is no justifiable placebo use outside of clinical trials.21
recognizing Quackery
Fraud and quackery are so pervasive that laws and en- forcement agencies are unable to adequately police or resolve the problem by themselves. Consumers must be alert for the purveyors of quackery and be able to recognize how they operate in the health marketplace. Table 3-2 describes their characteristic behavior. Quacks can be classified into three groups:
dumb quacks: These people know not, and don’t know that they know not. They may be uneducated, ignorant people who believe they have the secret formula or cure-all that no one else possesses. Generally they are small-time operators.
deluded quacks: These people know but have been misled into
knowing not. They often have some educational background and may even have a medical degree. Their beliefs are based on faulty observations and equally faulty reasoning. They may command large audiences and thereby be dangerous.
dishonest quacks: These people know not, and know that they know not. Their primary goal is money. They have no scruples.
Jarvis and Barrett12 warn that modern health quacks are super-salespeople:
Seldom do their victims realize how often or how skillfully they are cheated. Do viewers of an ad for a weight-loss “breakthrough” stop to think that a real breakthrough would be headlined in the news? Does the mother who feels good as she hands her child a vitamin pill think to ask herself whether it is really needed? Do buyers of “extra-strength pain relievers” wonder what’s in them or whether an unadvertised brand might cost less? Do users of “herbal energizers” realize that many herbs contain potent chemicals that may be harmful? Do subscribers to “health food” publications realize that articles are slanted to stimulate business for advertisers? Do people who hear testimonials stop to think that for every success there may have been dozens of failures? Do chiropractic patients who sign up for “preventive maintenance” know there is no sci- entific justification for such care? . . . . Do people who lobby for “health freedom” laws realize these are intended to excuse quacks from accountability rather than to improve consumer choice?
• They promise quick, dramatic, simple, painless, or drugless treatment or cures.
• They use anecdotes, case histories, or testimonials to support claims. Prominent people such as ac- tors, writers, athletes, and even physicians may be involved.
• They use disclaimers couched in pseudomedical or pseudoscientific jargon. Instead of promising to treat or cure specific illnesses, they offer to “detoxify” the body, “strengthen the immune system,” “balance body chemistry,” or bring the body into “harmony with nature.”
• They may display credentials or use titles that could be confused with those of reputable practitioners. Their use of the terms professor, doctor, or nutrition- ist may be spurious. Their credentials may be from a nonaccredited school or an organization that pro- motes nonscientific methods.
• The results they claim have not been verified or pub- lished in a reputable scientific journal.
• They claim that a single product or service can cure a wide range of unrelated illnesses.
• They claim to have a secret cure or one that is recog- nized in other parts of the world but not yet known or accepted in the United States.
• They claim to be persecuted by organized medicine and drug companies (“big pharma”) and that their treatment is being suppressed because it is controver- sial or because the medical establishment does not want competition.
• They state that medical doctors should not be trusted because surgery, x-rays, and drugs cause more harm than good. They say most doctors are “butchers” and “poisoners.”
• They claim that most Americans are poorly nourished and should take vitamins for “nutrition insurance.”
Any of these behaviors should make you highly suspi- cious. Additional signs of nutrition quackery are listed in Table 11–2.
Table 3-2
characTerisTic behaVior oF pracTiTioners and proMoTers oF Quackery
Part One Dynamics of the Health Marketplace42
Not usually. Quackery confuses people with double- speak—language that makes bad things sound good. Most people think that quackery and health frauds are easy to spot. Some are, but most are not. Today’s promoters wear the cloak of science. They use scientific terms and quote (or misquote) scientific references. On talk shows, they may be introduced as “scientists ahead of their time.” The very word “quack” helps their camouflage by making us think of an outlandish character selling snake oil from the back of a covered wagon—and, of course, no intelligent people would buy snake oil nowadays, would they? Well, maybe snake oil isn’t selling so well. But acu- puncture? “Organic” foods? Hair analysis? The latest diet book? Megavitamins? “Stress” formulas? Chelation therapy? Cholesterol-lowering teas? Homeopathic remedies? AIDS cures? Products that “cleanse your system”? Or vitamin shots to pep you up? Business is booming for health quacks. . . . Spot-reducers, “immune boosters,” water purifiers, “ergogenic aids,” bust creams, spinal adjustments for “preventive main- tenance,” devices to increase manhood, systems to “balance body chemistry,” cults to give life new meaning, special diets for arthritis. The list is endless. What sells is not the quality of their goods and services, but their ability to influence their audience. To those in pain, they promise relief. To the incurable, they offer hope. To the nutrition-conscious, they say, “Make sure you have enough.” To a public worried about pollution, they say, “Buy natural.” To one and all, they promise better health and a longer life. Modern quacks can reach people emotionally, on the level that counts the most.
Many people lack knowledge of what should pass for proof that something works.22 Because people tend to believe what they hear about the personal experience of others, testimonials can be powerful persuaders. Viss- ing and Petersen23 stated that testimonials offer the most powerful type of persuasion to try an unconventional method. Many years ago, Smith9 made this observation, which is still noteworthy:
Personal testimonials are not used in scientific medicine to prove or disprove the validity of therapies, and for good reason. There has never been a worthless or fraudulent treatment that could not produce a legion of persons who would swear that it helped or cured them.
conspiracy claiMs
Quacks typically charge that the medical profession, drug companies, the food industry, government agencies, and/or other “vested interests” are conspiring against “alternative medicine,” dietary supplements, and “natu- ral” health cures and that these alleged conspirators put profits ahead of public safety. Some practitioners, for example, charge that the American Medical Association
(AMA) and mainstream physicians are against them because their cures would cut into the incomes that doc- tors make by keeping people sick. Chelationists charge that doctors oppose chelation therapy because it would destroy the very profitable cardiac surgery industry, and cancer quacks claim that their methods pose an economic threat to the multi-billion-dollar “cancer industry.” Many quacks charge that their critics have been “bought off” by drug manufacturers who view “natural” methods as a threat to their enormous profits. Antifluoridationists falsely claim that the driving force behind water fluori- dation is a desire by the aluminum industry to sell waste products that are used to fluoridate public water supplies. Claims of “suppression” are used to market publica- tions as well as treatments. Many authors and publishers purport to offer information that your doctor, the AMA, and/or government agencies “don’t want you to know about.” The most noteworthy example is the book Natu- ral Cures “They” Don’t Want You to Know About,24 by Kevin Trudeau, a repeated lawbreaker whose activities are described in Chapter 25. Despite the extremely poor quality of its advice, it topped bestseller lists during much of 2005. The “conspiracy” charge is an attempt to gain sym- pathy by portraying the quack as an “underdog.” Jarvis25 has observed that, “Whereas individuals who complain about conspiracies directed toward themselves are likely to be regarded as mentally ill (paranoid), those who per- ceive them as directed against a nation, culture, or way of life may seem more rational.” Novella26 has noted:
Patients, especially those with a disease which is not curable by standard medicine, are eager to believe such conspiracy theories because they offer the hope they crave. It is far better to believe that there is a cure out there for you, with a small but dedicated band of rebels who will defy the establishment to bring it to you (for a fee of course), than to believe that no cure exists anywhere.
Although many people profit from health-related activities, the idea that great numbers of independent individuals, companies, and government agencies would—or could—conspire to suppress progress is complete fantasy. The elimination of serious diseases, for example, is not a threat to the medical profession. Researchers have much to gain financially and in terms of prestige by discovering therapeutic breakthroughs. Doctors prosper by curing diseases, not by keeping people sick. Moreover, all of the alleged conspirators and their families get sick themselves and would stand to lose if genuine treatments were suppressed. It should also be apparent that modern medical tech- nology has not altered the zeal of scientists to eliminate
Chapter Three Frauds and Quackery 43
disease. When polio was conquered, iron lungs became virtually obsolete, but nobody resisted this advance- ment even though it meant that hospitals would have to change. Actually, the greatest threat to quacks would be for the medical profession to adopt their methods and compete with them for patients.
The FreedoM-oF-choice issue
Promoters of quackery tend to disparage accepted scien- tific methods as well as consumer-protection laws. They argue that personal experience determines what works and that patients should be free to select any therapy they wish (Figure 3-1). They also argue that everyone should be free to market methods without the responsibility of ensuring that they are effective. The American Council on Science and Health27 described this version of “health freedom” as “nothing more than a hunting license for quacks.” Jarvis1 describes it as a ploy:
The “health freedom” argument is a classic example of de- ception by misdirection. . . . The reality is that patients may freely choose to do a variety of things. Patients may refuse treatments, swallow vitamins, eat apricot pits or the whole tree
if they wish. However, they may not sell their pet remedies in the marketplace if those remedies have not been proven safe and effective. The reason that patients clamor for dubious treatments is that they have been deceived into believing that these therapies offer hope. By focusing attention on the patients, the deceivers direct attention away from themselves.
Many groups that espouse unscientific methods have crusaded to weaken consumer-protection laws. These include the Alliance for Natural Health, the National Health Federation (NHF), the HealthKeepers Alliance, and the now-defunct Committee for Freedom of Choice in Medicine (CFCM). To promote their legal strategies these groups lobby, stage news events, and generate letter-writing campaigns to legislators and government agencies. During the mid- 1970s, for example, NHF and CFCM (then called the Committee for Freedom of Choice in Cancer Therapy) spearheaded passage of laws to permit the marketing of Laetrile (a bogus cancer remedy) within the borders of nearly half the states. In the 1990s several of these groups combined with health-food industry organiza- tions to generate a massive letter-writing campaign that led to passage of the Dietary Supplement Health and Education Act of 1994, which greatly weakened the ability of the FDA to protect consumers against useless and dangerous dietary supplement and herbal products (see Chapter 11). In recent years a few states have passed laws preventing their medical licensing board from disciplining physicians solely because they engage in “alternative” practices. Some have even authorized unlicensed individuals to offer health care. Chapter 8 discusses some of these anti-regulatory strategies. Consumers should have considerable right to choose the health products and services they wish to use. How- ever, they will benefit from this only to the extent that the marketplace is trustworthy. The fundamental principle of consumer protection (and federal law) is that methods
One of your parents is seriously ill with cancer, with little hope of recovery. Treatment at a large medical center has not succeeded in curing or alleviating the condition. A friend of your parents told them he was helped by a clinic in Mexico that uses a substance, unavailable in the United States, that cures a high percentage of cancer patients who receive it. Despite its high cost, your parents are considering a trip to Mexico. What can you do to help them reach an intelligent decision? How sensible would it be for them to spend their life savings for the treatment?
It’s Your Decision
WE—THE PEOPLE of the United States, propose AMENDMENT XXVII to be known as the HEALTH- CARE RIGHTS AMENDMENT, which should read as follows:
HEALTHCARE RIGHTS AMENDMENT SECTION 1. The Congress shall make no law which restricts any individual’s right to choose and to practice the type of healthcare they shall elect for themselves or their children for the prevention or treatment of any disease, injury, illness or ailment of the body or the mind.
Figure 3-1. “Healthcare Rights Amendment.” A now-defunct “consumer group” gathered approximately 100,000 signatures supporting a constitutional amendment to establish “health freedom.” If it were enacted, government agencies could no longer stop the marketing of unproven or dangerous remedies if even one consumer wanted them. Anyone, licensed or not, could engage in any practice labeled “health care” so long as a single consumer wished it to continue. Compulsory immunization would end, and courts could no longer protect children from parents who deny them access to effective treatment, even if such neglect would result in their death.
Part One Dynamics of the Health Marketplace44
should not be marketed until they have been proven safe and effective by scientific study. Abolishing this safe- guard would have disastrous consequences, especially for seriously ill people who must quickly decide what to do. Such people should not have to sort through a mix that includes cleverly worded but empty promises.
suMMary
Despite the tremendous advances in medical science and health education, health frauds and quackery are still common. Americans waste huge amounts of money on unproven and unscientific approaches to health care. Faced with the prospect of chronic suffering, deformity, or death, many individuals are tempted to try anything that offers relief or hope. Health frauds and quackery can cause financial, physical, and psychologic harm. It is extremely important for consumers to under- stand the concepts of spontaneous remission and the placebo effect. The mere fact that someone feels better after trying a remedy does not prove that the remedy was effective. Most diseases are self-limiting, and placebos can relieve a broad range of symptoms. Modern quacks can be difficult to recognize. How- ever, certain behavior patterns should help consumers identify them. It is important for consumers to complain to appro- priate authorities when they encounter deception in the marketplace.
reFerences
1. Jarvis WT. How quackery is promoted. In Barrett S, Cassileth BR, editors. Dubious Cancer Treatment: A Report on “Alterna- tive” Methods and the Practitioners and Patients Who Use Them. Tampa, 1991, Florida Division of the American Cancer Society.
2. Barrett S. Gregory Caplinger and his cancer scam. Quackwatch Web site, July 12, 2009.
3. The California Medical Association. The Professional’s Guide to Health and Nutrition Fraud. San Francisco, 1987, The Association.
4. United States House of Representatives, Select Committee on Aging, Subcommittee on Health and Long-term Care. Quackery: A $10 Billion Scandal (2 volumes). Washington, DC, 1984, US Government Printing Office.
5. Top 10 health frauds. FDA Consumer 23(8):29–31, Oct 1989. (Slightly updated for the Quackwatch Web site)
6. Beyerstein BL. Why bogus therapies often seem to work. Quackwatch Web site, 1998.
7. Pratkanis AR. How to sell a pseudoscience. Skeptical Inquirer 19(4):19–25, 1995.
8. Jarvis WT. How quackery harms cancer patients. Quackwatch Web site, 1997.
9. Smith RL. At Your Own Risk: The Case against Chiropractic. New York, 1969, Pocket Books.
10. Copeland C. Deception at a New Age clinic. Journal of Christian Nursing 6:5–7, Spring 1989.
11. Bianchini M. Testimony in Her Majesty the Queen v. Sonia Atikian and Khachadour Atikian. Toronto, June 28, 1991.
12. Jarvis WT, Barrett S. How quackery sells. In Barrett S, Jarvis WT, editors. The Health Robbers: A Close Look at Quackery in America. Amherst, N.Y., 1993, Prometheus Books.
13. Randi J. The Faith Healers. Amherst, N.Y., 1989, Prometheus Books.
14. Young JH. Why quackery persists. In Barrett S, Jarvis WT, editors. The Health Robbers: A Close Look at Quackery in America. Amherst, N.Y., 1993, Prometheus Books.
15. Beyerstein BL. Testing claims of therapeutic efficacy. Rational Enquirer 7(4):1–2, 8, 1995.
16. Jarvis WT. Arthritis: Folk remedies and quackery. Nutrition Forum 7:1–3, 1990.
17. Rosensweig P and others. The placebo effect in healthy vol- unteers: Influence of experimental conditions on the adverse events profile during phase I studies. Clinical Pharmacology and Therapeutics 54:578–583, 1993.
18. Turner JA and others. The importance of placebo effects in pain treatment and research. JAMA 271:1609–1614, 1994.
19. Barrett S. Health frauds and quackery. FDA Consumer 11(9):12– 17, 1977.
20. Canter PH. Why integrated medicine should be treated with great suspicion. Focus on Alternative and Complementary Therapies 9:193–195, 2004.
21. Hrobjartsson A, Gotzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. NEJM 344:1594–1602, 2001.
22. Jarvis WT. Quackery: A national scandal. Clinical Chemistry 38:1574–1586, 1992.
23. Vissing MV, Petersen JC. Taking laetrile: Conversion to medical deviance. CA—A Cancer Journal for Clinicians 31:365–369, 1981.
24. Trudeau K. Natural Cures “They” Don’t Want You to Know About. Hinsdale, Ill., 2004, 2005, Alliance Publishing Group.
25. Jarvis WT. Why health professionals become quacks. Quackwatch Web site, Dec 11, 1998.
26. Novella S. Medical conspiracies and the myth of the “hidden cure.” In Sampson WI, Vaughn L, editors. Science Meets Alter- native Medicine: What the Evidence Says about Unconventional Treatments. Amherst, N.Y., 2000, Prometheus Books.
27. Barrett S. The unhealthy alliance: Crusaders for “health free- dom.” New York, 1988, American Council on Science and Health.
Advertising And Other PrOmOtiOnAl
Activities
The public is constantly being bombarded by those who wish to pro- mote their own views, sell a bill of goods, convert others to a cause, or convince us that they have discovered a special truth or have found a unique road to salvation. Paul Kurtz, Ph.D.1
All things should be laid bare so that the buyer may not be in any way ignorant of anything the seller knows. CiCero
Freedom of speech doesn’t give a person the right to shout “fire” in a crowded theater. . . . Nor should it give con artists the right to promote health frauds through ads in print or on the air. Yet, health fraud lives and thrives . . . because of successful advertising.
roger Miller2
FDA Consumer, 1985
© medical economics, 1985
“I like it, Blitherington. Now come up with a product.”
Chapter Four
Part One Dynamics of the Health Marketplace46
The prevailing philosophy of our free-enterprise system is based on the profit motive. It permits sellers to supply what consumers want and buyers
to select the products they believe will be advantageous. In the health marketplace, consumers should regard promotional activities cautiously. Although advertising can supply useful information, intelligent consumers should follow the principle of caveat emptor (let the buyer beware). Business leaders view promotion in different ways. Some say that advertising has the obligation to commu- nicate messages clearly, accurately, honestly, and with interest and impact. Others have said that “the solution to marketing problems is not one of giving consumers what they want, but rather to make consumers want what we, the marketers, want them to want” and that advertis- ers are “concerned not with finding an audience to hear their message, but rather with finding a message to hold their audience.” William Lutz,3 author of Doublespeak, states that “the job of advertising is to make something out of nothing.” Mainstream physicians and hospitals tend to market their services more conservatively than the business community, but abuses exist among them also. Advertisements are not the only form of promotion. Many sellers spread their messages through the news and entertainment media. Some entrepreneurs host their own talk shows. Multilevel marketers spread their ideas from person to person. Many people hawk their wares through books, lectures, Web sites, computer newsgroups, and press conferences. This chapter describes how advertising and other marketing activities can mislead consumers. It also examines problems with the advertising of mail-order health products, professional services, drug products, foods, dietary supplements, homeopathic products, exercise and fitness products, weight-control products and services, and tobacco products.
PsychOlOgic mAniPulAtiOn
The business world uses insights from psychology and other social sciences to manipulate consumer behavior. Many companies base their marketing strategies on re- search that determines what governs people’s choices. Armed with such knowledge, advertisers can often persuade people to buy things in a predictable manner. Cosmetics manufacturers, for example, are not sell- ing merely lanolin, but fantasies involving attractiveness. Women who normally would pay less than $1 for a bar of soap might be willing to pay much more for a skin cream they hope will make them more attractive (see Chapter 18). Purchasers of a cosmetic alleged to remove wrinkles are seeking everlasting youth and social ac- ceptance. Shampoo buyers may be hoping for romance. For decades, cigarette ads used images of youth, health, vigor, and social acceptance to convey the op- posite of what cigarette smoking will do to smokers. A widely aired series of television ads has portrayed coffee as a valuable aid to friendship and romance. Many ads link alcoholic beverages to success, sociability, elegance, relaxation, romance, and adventure. Many ads offer simple answers to people’s hopes, and fears. Ads suggest products to enhance sexual performance or provide relief from a boring or lonely life. Many offer quick, simple, painless solutions. They encourage pill-taking for insomnia, tension, and lack of energy. Ads for baldness remedies, weight-control products, deodorants, impotence cures, bust enhanc- ers, and penis enlargers exploit feelings of inferiority and suggest that using these products will bring social success. Vitamin ads picture energetic people. Many ads falsely suggest that dietary supplements boost im- munity. Ads for “ergogenic aids” feature bodybuilding champions without indicating that the primary ingredi- ent of athletic success is hard work. Table 4-1 illustrates common persuasive techniques.
• The main purpose of advertising is to sell rather than to inform. Many ads that are not blatantly false do not tell the whole truth.
• Many ads for products are designed to distract attention from the risks involved in using them.
• Many health professionals who advertise do not represent their services accurately or comprehensively.
• The vast majority of health-related products marketed primarily by mail, by telephone, through infomercials, through the Internet, and from person to person are worthless, overpriced, or both.
• Misleading advertising is so widespread that government agencies cannot stop most law violators they detect.
KeeP these POints in mind As yOu study this chAPter
Key Concepts
Chapter Four Advertising and Other Promotional Activities 47
Visual imagery is sometimes used to exaggerate the truth. For example, Crest toothpaste has shown a “fluo- ride eraser” rubbing out a substantial black carious area on a tooth. Fluoridated toothpaste is valuable because it helps prevent decay, but it does not cure cavities. Prat- kanis and Aronson4 have noted that appeals to fear are
most effective when they terrify the recipient and offer a specific solution. Television ads for headache remedies often use soothing background music to promote their par- ticular brand of pain reliever. Many ads encourage self-diagnosis and self-treatment. Consumers who are
Technique Power words to gain attention
“Strengthens immune system”
“Fights . . .” “Free,” “Money back guarantee” “It’s natural” “Amazing breakthrough” “Ask your doctor” “FDA-approved” “Used by millions” “Scientifically tested”
“Contains twice as much . . .” “Wrinkle eraser” “Isn’t it time you tried . . .” “Contains X”
“Up to 8-hour relief” “Provides relief three times longer” “Less salt, fat, calories” “Fast-acting,” “Inexpensive” “Guaranteed purity, potency, and quality” “Clinically proven safe and effective”
Imagery to appeal to emotion
“Quiet world is like taking a vacation from tension” “Beautiful people, places, things” “The Marlboro man” “Look younger instantly” “Created by research scientist (or special ist)” “Miracle beauty secret, no surgery” “Used extensively in Europe” “Before-and-after pictures”
Weasel words
“Helps . . .” “Virtually . . .” “New and improved”
techniques used in Advertising
Table 4-1
Questions to Raise
Is this possible? Will it prevent infections? Will it harm people with diseases for which the immune system is overactive?
How? Is it effective? What is free? Is this a come-on? What do you pay for? Will the company honor its pledge? What is “natural?” Is it better? More expensive? Who says? What evidence? How effective? Do doctors generally recommend this product? Is it actually approved? For what purpose? Is it really? Is popularity a good measure of effectiveness? How? By whom? Were studies well-designed?
Is it better than taking twice as much of another product? Does it really erase? Or cover temporarily? Why? Because everybody does? What is X? What does it do? Is it better than the ingredient(s) of
competing products? What is “up to”? How long is the relief typically? Longer than what? Why not four times? Less than what? Is it still high? How does it compare to other products? Does the product work? What’s the evidence?
Will it help you escape from problems? The real world? Will the product help you achieve this? Is smoking macho? Or is it foolish and unhealthy? How quickly? Possible? Temporary? Aren’t most products? Qualifications? What is? Why secret? Does it work? Why not in the United States? Not FDA-approved? Do they depict typical results? Were they faked?
Does it? In what way? How much? Does it or doesn’t it do what surrounding words imply? How was it changed? Is it more effective?
Misleading comparisons to encourage consumers to jump to conclusions
Part One Dynamics of the Health Marketplace48
interested in self-care (Chapter 14) are targets for decep- tive advertising. Many companies plug health-related products by issuing press releases or canned video news reports. The resultant press coverage may have greater impact and cost the manufacturer less than regular ads. Prescription drug manufacturers and supplement companies often use this method to call public attention to new products or preliminary scientific reports. Print ads are sometimes formatted to look like news reports.
Puffery, WeAsel WOrds, And hAlf-truths
In many ads the primary technique is puffery, which Preston defines as praise that includes opinions, super- latives, exaggerations, or generalities, but no specific facts. Preston5 states: “Puffery lies to you and it deceives you, but the law says it doesn’t.” In The Great American Blow-Up, he provides this illustration:
The book you are about to read is a superior piece of work. It demonstrates the sheerest true excellence in its treatment of one of the outstanding important topics of our time. You will find every moment informative and entertaining to a degree you have never before encountered in the world of fine literature. This much-applauded volume has earned for its author a rightful place as one of the top writers on the contemporary scene.
He then states:
The paragraph you have just read is the purest baloney. . . . It is puffery. It is the pretentious opinion of salesmen and ad- vertisers exaggerating their wares, magnifying value, quality and attractiveness to the limits of plausibility and beyond. It is false, and I know it is false. I do not believe it. If you had believed it, and had bought this book because you relied upon the belief, you would have gotten less than you had bargained for in the marketplace. You would have been cheated.
Puffery is often used to promote nonprescription drugs. For example, Bayer aspirin has been said to “work wonders,” and Pepto-Bismol has been touted as having “the famous coating action.” Many pain relievers, vitamins, and other products are identified as “advanced formulas.” The word “revolutionary” is liberally used to describe dietary supplement formulas and diet books. In July 2011, a Google search for the phrase “amazing health secrets” found more than 340,000 links. Another selling trick is the use of “weasel words.” These create the illusion of a promise but permit the advertiser to “weasel” out of the deal later. Here is an example from the catalog of a laboratory that supplies “glandular” products to chiropractors. These products are composed of dehydrated animal organs but contain
no hormone or other pharmacologically active ingredi- ent. They are mainly ordinary proteins made into pills or capsules. But according to the catalog (the weasel words are italicized for the purposes of this textbook):
These glandular concentrates reportedly go directly to the aid of the gland of the same name . . . liver to liver, eye to eye, prostate to prostate, and so forth. Theoretically, the nutrients found in glands may contain essential factors, and when taken as a supplement, will help the body’s glands reach and maintain proper functioning levels.
Despite the illusion that the products are useful, the ad actually promises nothing. Another example would be a promised weight loss of “up to 20 pounds in 30 days.” Many statements in advertising, although literally true, could be misunderstood by consumers to mean things that are not true. For example, a claim that one food product has more “food energy” than that of its competitors may be literally true because “food energy” is simply a synonym for calories. Yet the consuming public may relate “food energy” to feeling energetic and interpret the claim to mean something that is untrue. Many ad claims have multiple meanings, one of which may be false or unsubstantiated. To some consumers a “better” product should be better than competing prod- ucts. To others, “better” may mean superior to previous versions of the product itself. If a product is claimed to be better, consumers should ask, “Better than what?” Boush and others7 have noted that deceit-minded marketers want the target consumer to notice and process only favorable message parts and to ignore disclosures or suggestions of drawbacks, risks, and limitations. Many advertisers believe they have license to mis- lead people as long as nothing explicitly false is said.
√ Consumer Tip
Consumptive Behavior 101 • Human behavior is purposive: to maintain and
enhance one’s self-concept. • Human behavior is learned behavior; that which is
rewarded is repeated, and that which is punished or ignored becomes extinct.
• People buy only two things: good feelings and solu- tions to problems.
• People make decisions with their emotions then justify with logic.
• People use a lot of shortcuts in decision-making because of the increasing tendency for cognitive overload.
Nabil Y. Razzouk, Ph.D.6
Chapter Four Advertising and Other Promotional Activities 49
Years ago, a Harvard Business Review poll of 2700 executives found that two out of three believed that ad- vertising failed to present a true picture of the product advertised. They were uneasy about the truthfulness and the social impact of ads.8 A similar poll of business school deans rated honesty in advertising to be 13%.9
mArKeting Outlets
The number of marketing outlets is enormous. There are tens of thousands of daily and weekly newspapers, magazines, and radio and television stations. Many sell- ers obtain publicity through the use of public relations agencies, press releases, and public appearances. Prod- ucts are also marketed through direct mail, by telephone, by word of mouth, and through the Internet. It has been estimated that the average American is exposed to 1500 advertising messages a day. The cost of advertising depends mainly on the size of the audience it can reach. Ads can cost anywhere from a few dollars for a 30-second radio spot on a small station to tens of thousands of dollars for ads in popular magazines to more than $2 million for a 30-second nationwide televi- sion ad aired during the Super Bowl. The Internet probably enables advertisers to deliver more information at lower cost per view than any other medium. In addition to obvious ads, consumers should also be wary of claims made in press releases they en- counter through Web searches. Many people believe that advertising must be rea- sonably truthful or it would somehow not be permitted. However, standards for advertising acceptability vary greatly. Some outlets do their best not to carry mislead- ing ads, whereas others care very little about truth in advertising. Government regulation curbs some decep- tive promotions, but it cannot stop most of them. The impact of advertising extends beyond the ads themselves. Many advertising outlets will not convey news or viewpoints that would place their advertisers in an unfavorable light. Some outlets deliberately promote their advertisers’ wares. Radio talk shows sponsored by health-food stores, for example, interview a steady stream of guests who promote the types of products sold in the stores. Health-food industry and bodybuild- ing publications invariably boost the types of products marketed by their advertisers.10
The integrity of advertising is unlikely to improve unless our government finds a way to penalize the media that profit from distributing misleading ads. The nature and extent of health-related advertis- ing raise serious questions about its effect on people’s
health. What kind of society is being produced by the information transmitted? Is the selling of more health products and services a good thing for consumers? Does a belief in caveat emptor absolve the seller who encourages behavior detrimental to health? Is it right to profit by playing on people’s hopes, fears, and anxieties? Regardless, consumers should still protect themselves by intelligently analyzing the ads they encounter.
PrOfessiOnAl Advertising
Medical and dental societies traditionally have frowned on the use of advertising to solicit patients. Years ago, members who advertised might be expelled, and many state laws banned or severely restricted advertising by health professionals. However, court decisions and pres- sure by the Federal Trade Commission (FTC) forced professional societies to abolish their ethical restraints on advertising. The FTC is legally responsible for helping to foster competition and prevent price-fixing. In 1978 an FTC adminitrative law judge ruled that the American Medical Association (AMA) could no longer forbid advertising by its members. After the U.S. Supreme Court upheld this order (in 1982) the AMA Council on Ethical and Judicial Affairs removed all restrictions on advertising “except those that can be specifically justified to protect the public from deceptive practices. . . . . The key issue is whether advertising or publicity, regardless of format or content, is true and not materially misleading.” How- ever, the Council cautions that statements relating to the quality of medical services may be a problem because they may be difficult or impossible to measure by objec- tive standards.11 The American Dental Association also changed its guidelines. The FTC believes that advertising lowers prices by increasing competition and provides consumers with ad- ditional information that will help them make appropriate decisions. However, advertising by health professionals can have serious consequences that FTC policy does not address: (a) advertising enables the least qualified practitioners to try to lure patients through salesman- ship rather than demonstrations of competence, and (b) advertising does not lower medical fees because it tends to increase both the demand for services and the cost of delivering them. The amount of professional advertis- ing has increased greatly since the 1982 Supreme Court decision. The most appropriate approach in health-care ad- vertising is one that accurately informs the public of facilities and useful services offered. Figure 4-1 shows a
Part One Dynamics of the Health Marketplace50
clever message that calls attention to appropriate preven- tive care. Figure 4-2 shows a responsible ad that attempts to attract patients by offering a discount coupon for a dental examination. Ads by medical and dental societies tend to be useful and informative. Flamboyant advertising is probably a sign of low- quality, mass-production service. For example, the Lasik Vision Institute (LVI), which operates facilities in many states, has widely advertised fees of $299 or $499 per eye for refractive surgery. But regulatory actions and media investigations suggest that this number was intended to lure patients into consultations at which much higher prices are quoted.12 In 2003 LVI signed an FTC consent agreement to settle charges that the company failed to substantiate claims that its Lasik operations would eliminate the need for glasses and contact lenses for life and eliminate the need for reading glasses or bifocals.13
Page 427 has additional details about LVI. Ads for questionable screening tests have also been a matter of concern. A study14 of 60 advertisements and brochures for self-referred computed tomography (CT) and magnetic resonance imaging (MRI) screening tests found that many of them were misleading. Noting that the marketers emphasized potential benefits but almost never mentioned real risks (such as the ultimate cost of false-positive tests), the researchers concluded:
Direct-to-consumer marketing of self-referred imaging ser- vices . . . fails to provide prospective consumers with compre- hensive balanced information vital to informed autonomous decision making. Professional guidelines and oversight for advertising and promotion of these services are needed.
The largest number of ads in the study came from HealthScan America, Inc., which did business in Cali- fornia under the name of AmeriScan. About 14 months before the study was published, the San Francisco District Attorney and the Medical Board of California jointly filed suit against the company and the doctor who founded it. The suit sought to halt advertising claims that the company’s MRI BreastScreen was “the absolute most
accurate technology available for the early detection of breast cancer” and had been “proven to find nearly 100% of all breast cancers.” The regulators believed that the ads were intended to scare women away from mammog- raphy in order to sell them a $2,000 MRI BreastScreen. Soon after the suit was filed, the AmeriScan centers were closed. Telephone directory publishers have shown little or no interest in preventing unqualified individuals from misrepresenting their credentials. In Allentown, Pennsyl- vania, for example, an anesthesiologist with an interest in hypnosis for pain relief was permitted to advertise himself as a psychiatrist despite protests made to both the directory publisher and the state medical board. To counter this type of problem, the American Board of Medical Specialties places lists of board-certified phy- sicians in many of the Yellow Pages. However, many board-certified physicians do not participate because they do not wish to pay the required fee. Many people advertising under the heading “Nutritionists” are un- qualified (see Chapter 11). Many chiropractic ads are misleading; the “free” spinal examinations or postural screening they offer nearly always result in a recommendation for lengthy treatment.15 Figure 4-3 illustrates one such solicitation.
mArKeting by hOsPitAls
Rising overhead costs have placed many hospitals in a precarious financial position. In many communities, hospitals are engaged in extensive marketing plans intended to ensure that they fill their beds. These may include ads for emergency services; outpatient clinics; programs for alcoholism, drug addiction, and chronic pain; fitness programs; smoking-cessation courses; medical referral services; community lectures; and other activities designed to boost community awareness of the hospital and its facilities. Some hospitals offer Saturday surgery (for convenience), gourmet food, newsletters to former patients, and free transportation. A few have used
figure 4-2. Straightforward ad with discount for first visit.figure 4-1. Innovative ad alluding to auto maintenance.
.
Chapter Four Advertising and Other Promotional Activities 51
gimmicks such as a “$10 off” coupon for emergency room services. Many hospital marketing campaigns anticipate consumer needs and offer useful services. On the other hand, many hospitals have “integrative medi- cine” clinics that claim to offer the best of both standard and “alternative” medical services. As Chapter 8 notes, adding ineffective services to effective ones raises costs without benefit to the patients. In many hospitals, even though science-based staff members object, hospital administrators maintain these programs for marketing purposes. The American Hospital Association’s guidelines for ethical advertising state16:
Advertising may be used to advance the health care organiza- tion’s goals and objectives and should, in all cases, support the mission of the health care organization. Advertising may be used to educate the public, to report to the community, to increase awareness of available services, to increase sup- port for the organization, and to recruit employees. Health care advertising should be truthful, fair, accurate, complete,
and sensitive to the health care needs of the public. False or misleading statements, or statements that might lead the uninformed to draw false conclusions about the health care facility, its competitors, or other health care providers are unacceptable and unethical.
Figure 4-4 shows a straightforward ad for people experiencing symptoms related to anxiety.
PrescriPtiOn drug mArKeting
Prescription drug marketing traditionally has been di- rected toward physicians, dentists, and other health-care personnel in professional and technical magazines. The FDA regulates this and requires ads and package inserts to include full information about dosage, effective- ness, side effects, adverse reactions, precautions, and contraindications.
Promotion to Physicians Pharmaceutical companies spend several billion dollars a year promoting prescription drugs to physicians. This promotion has included not only advertising but also individual visits by sales representatives, free samples and gifts, continuing education courses, dinner presenta- tions, and other perquisites. During the past few years, however, many medical training centers and profes- sional groups have taken steps to ban or discourage perks and other interactions with drug companies or their representatives that might unduly influence what doctors prescribe.
Direct-to-Consumer Advertising For many years the FDA opposed the advertising of prescription drugs to the public because the informa- tion needed to make intelligent decisions about them is generally too complex to place in a brief advertisement. But in 1999 the agency issued guidelines that it believed would safeguard consumers.17
figure 4-4. Straightforward ad for a hospital program that includes a free evaluation of anxiety-related symptoms.
figure 4-3. “Danger signal” ad from a phone book. It is misleading because: (a) the listed symptoms are not usually caused by “pinched nerves,” (b) most cases involving such symptoms are not serious, and (c) some of the symptoms are likely to be appropriate for medical rather than chiropractic evaluation. Respondents to ads like these are almost always told they have a spinal problem that needs prolonged care—often between 50 and 100 visits!
Part One Dynamics of the Health Marketplace52
Manufacturers now spend several billions of dollars per year to advertise prescription products in magazines and newspapers, on television, and through Web sites. It has been estimated that American television viewers see as many as 16 hours of drug ads per year.18 Some ads mention a product by name, whereas others encour- age people with certain health problems to seek further medical advice. Most drugs in the latter category are either the only drug or the market leader in a category of drugs for the advertised problem. Figures 4-5 and 4-6 show ads that provided helpful, informative messages. Ads that mention a prescription drug by name must include “adequate directions for use.” This includes full product information of the type found in package inserts and the Physicians’ Desk Reference. This amount of information is often too technical for laypersons to understand. Less information is required in ads that do not name a specific product.19
Although prescription drug ads call attention to useful products, their primary purpose is to sell them. Some observers believe that direct advertising educates patients, alerts consumers to new treatments, encourages people to seek medical advice for conditions that would otherwise go untreated, increases consumer confidence in products already prescribed, and generally results in
a more informed public.20 Others argue that advertising prescription drugs interferes with the physician-patient relationship, confuses patients, increases the cost of drugs, puts undue emphasis on drug treatment alterna- tives, pressures doctors to prescribe products, and results in unnecessary use.21 Several years ago, nearly 90% of AMA members responding to a poll stated that direct-to- consumer advertising had resulted in increased patient demand for specified brand-name drugs, and 73% said that it caused physicians to spend more time supplying accurate information. It has also been suggested that direct-to-consumer drug ads contribute to the medicalization of what was previously considered part of the normal range of human experience.22 Consumer Reports on Health23 has warned:
Drug pitches are not public service messages—they’re com- mercial advertisements . . . designed with the drug manufac- turer’s health in mind. Even when the ad seems to be merely alerting you to symptoms that may require drug treatment, the message is usually overstated. . . . You should regard consumer
figure 4-5. Informative ad which advised people that it is possible to have high blood pressure without knowing about it. The ad mentioned no product, but the manufacturer assumed that some people who were discovered to have “silent” hypertension would be appropriately treated with one of its products.
Figure 4-6. A useful message from the manufacturer of a prescription drug that can help control the symptoms and reduce the transmission of genital herpes.
Whether you have a mild, intermediate or severe case of genital herpes, you should see your doctor to help gain new control over your outbreaks— especially if you haven’t seen your doctor within the past year. The medical profession now has more infor- mation than ever before about the treatment of herpes, as well as effective counseling and treatment
programs that can help you reduce the frequency, duration and severity of your outbreaks. If in the past, you were told that nothing could be done for herpes, it’s no longer true. Herpes is controllable. Ask your doctor about these treatment pro- grams, and whether one of them would be suitable for you.
Chapter Four Advertising and Other Promotional Activities 53
drug ads with the same type of skepticism as you would any other type of salesmanship.
The article noted, for example, that Rogaine’s manufac- turer had tried to hook worried men by asking whether “an emerging bald spot” can “damage your ability to get along with others” or “influence your chances of obtaining a job or a date.” A 2004 survey24 of major network prime time televi- sion ads made the following observations:
• More than 80% made some factual claims and rational arguments for product use, but only about 25% described the causes, risk factors, and prevalence of the targeted problems. Nearly all made emotional appeals.
• No ads mentioned lifestyle change as an alternative to prod- ucts, though some portrayed it as an adjunct to medication.
• About half portrayed the product as a medical breakthrough. • The ads had limited educational value and tended to over-
sell the benefits of drugs in ways that might conflict with promoting population health.
Frosch and others25 believe that direct ads should (a) be written at an eighth-grade level, (b) clearly indicate whether the product might be useful to the viewer, and (c) provide realistic, quantitative information about the potential benefits and risks.
nOnPrescriPtiOn drug Advertising
In 1972 the FDA began a lengthy review process that has led to the removal of many ineffective ingredients
from nonprescription drugs (see Chapter 17). In ad- dition, regulatory actions by the FTC have persuaded many major manufacturers to stop making blatantly misleading claims. As a result, except for homeopathic products (see Chapter 8), most nonprescription drugs sold today contain at least one effective ingredient, and ads for such products tend to be truthful. However, at least three problems remain:
1. Ads often fail to disclose the ingredients of the product. This makes it more difficult for consumers to choose the most suitable product or compare one product to another. Multi-ingredient products promoted for the relief of colds, for example, may not be better than products that contain fewer ingredients or a single ingredient.
2. Many ads use imagery, puffery, testimonials, or dubious ref- erences to clinical studies to suggest that a product is more effective than it actually is. Pain relievers, for example, may be described as “advanced,” “new,” and “extra-strength,” even though their ingredients are identical or very similar to those of competing products.
3. Commercial television viewers, bombarded by ads, may incorrectly conclude that many of life’s problems can be solved by drugs. Ads for “Excedrin headaches” are a classic example in which viewers were encouraged to use medica- tion to relieve tension headaches with no mention that trying to resolve the underlying problem would be prudent.
tObAccO PrOmOtiOn
Although cigarette consumption in the United States has declined in the last 25 years, over 430,000 deaths each year are attributable to smoking, and additional deaths are related to secondhand smoke.27 Yet for many years tobacco products were America’s most heavily marketed consumer product. Tobacco-product advertising has been banned on television and radio, and warnings about health risks are required on the labels of cigarettes and smokeless tobacco products. However, until recently, these products were extensively promoted through print advertising, sporting and cultural events, and motion pictures that encouraged smoking. Tobacco ads associated smoking with affluence, glamour, slimness, visceral satisfaction, romance, popularity, escape from worry, winning friends, gaining independence, relaxation, fitness, and upward mobility. Cigarette promotion changed as a result of lawsuits by state attorneys general. In 1998 the five largest to- bacco companies agreed to stop billboard advertising, restrict brand-name sponsorships of events with sig- nificant youth audiences, stop using cartoon characters, and discontinue various other marketing methods.28
Personal Glimpse
Targeting Women Advertising often reduces the political to the personal. We are told that all we need to do is use the right prod- ucts and get our own individual acts together, and all will be fine. . . . For example, if we are having difficulty with child care, the solution is to give our children sweets so they will love us, not to lobby for a national child care policy. If we are having trouble in our relationships with men, we can buy a book that will encourage us to make ourselves more agreeable to men, rather than joining a consciousness-raising group that might lead us in another direction. If we are unhappy, there is something wrong with us that can be solved by buying something. We can smoke a cigarette or have a drink or eat some ice cream. Or we can lose some weight. Jean Kilbourne, Ed.D.26
Part One Dynamics of the Health Marketplace54
But their promotional expense continued to increase, with emphasis on retail outlets frequented by youths.29
Polansky and Glantz,30 who believe there has been a dose-response relationship between teens’ exposure to on-screen smoking and smoking initiation, have reported that 80% of the 776 movies produced and released in the United States from 1999 through 2003 depicted smoking. The 2009 Family Smoking Prevention and Tobacco Control Act gives the FDA authority to regulate the con- tent, marketing, and sale of tobacco products. Among other things, it limits advertising that could attract young smokers and requires FDA approval for descriptors such as “light,” “mild,” or “low” that imply that a product poses less of a health risk. As of September 2012, all cigarette packaging and advertising must display graphic images that reflect the consequences of cigarette use.
fOOd Advertising Public focus on the relationships between diet and vari- ous diseases, particularly heart disease and cancer, has spawned an enormous number of related advertising claims. In the mid-1980s many food manufacturers be- gan suggesting that their products might protect, or help protect, against certain diseases. Many of these claims were misleading because they stressed individual foods rather than overall diet. In addition, ads for certain foods emphasized a potentially helpful quality (such as being low in cholesterol) when another characteristic (such as a high fat content) would negate any benefit. These problems were largely solved by FDA labeling regula- tions that took effect in 1994 (see Chapter 11). The big problem with food advertising is that it tends to promote dietary imbalance and much of it targets children. Bell and others31 examined a random sample of advertisements appearing on weekday afternoons and Saturday morning on 12 networks catering to Spanish- language audiences, children, youth, black youth, and general audiences. They reported that 70% of food ads were for items high in sugar or fat and that ads for fruits and vegetables were rare (1.7%). Culp and others 32 monitored two children’s tele- vision networks and found that about 30% of the ads were for food, beverages, or restaurants and promoted a company’s Web site. The researchers visited 19 such sites and found that (a) most used games and other strat- egies to keep the children engaged for long periods of time, and (b) the sites almost exclusively promoted food items high in sugar and fat and provided an average of one “healthful” nutritional or physical fitness message for every 45 exposures to brand identifiers.
In 2009, Kellogg Company, the world’s leading cereal producer, agreed to settle FTC charges that adver- tising claims touting a breakfast of Frosted Mini-Wheats as “clinically shown to improve kids’ attentiveness by nearly 20%” were false. The FTC noted that the study to which the ads referred found that only about half the cereal-eaters showed any improvement in attentiveness, and only about one in nine improved by 20% or more.33 The settlement bars the company from misrepresent- ing any tests or studies but contains no admission of wrongdoing or financial penalty. Noting that Kellogg’s 2007 sales had exceeded $11 billion, Dr. Stephen Barrett submitted the following public comment to the FTC:
I believe that Kellogg should be required to pay a fine be- cause its advertising was unconscionable. The fact that the ad misrepresented the numbers in the study was only part of the problem. The study itself was deliberately designed to be misinterpreted because it compared children who were hun- gry (no breakfast) to children who were fed. A real study to determine the value of Mini-Wheats would compare children who had various types of breakfast. . . . If you really want to deter wrongdoing, you should also insist that Kellogg issue a corrective ad stating that the study itself was poorly designed.
The American Academy of Pediatrics believes that television food advertising aimed at children should be stopped. In a policy statement, the Academy charged that the primary goal of children’s television is to sell prod- ucts to children, but young children cannot distinguish between programs and commercials and do not under- stand that commercials are designed to sell products.
dietAry suPPlement PrOmOtiOn
Much of the advertising for vitamin products and other products marketed as dietary supplements is mislead- ing. Many companies falsely suggest that supplements should be taken because it is difficult or impossible to meet nutrient needs with ordinary foods or in times of stress. Ads for supplements never inform people how to accurately judge whether they need them. Many products are marketed with false and illegal claims that they can prevent or treat various diseases. Supplements are also promoted through books, magazines, radio and televi- sion broadcasts, oral claims from person to person, and other channels. Unwarranted claims made through these channels are protected by the doctrines of free speech and freedom of the press as long as they are not directly tied to the sale of specific products. These problems are described in Chapter 11. Many supplement manufacturers suggest that their products have characteristics that make them unique
Chapter Four Advertising and Other Promotional Activities 55
“Tired Blood” One of the catchiest advertising campaigns of all time was the promotion of Geritol for people with “tired blood.” The ad-makers reasoned that since iron deficiency causes anemia, and anemia causes fatigue, people who are tired should take an iron tonic. This play on words was invalid because iron-deficiency anemia is not the usual cause of fatigue, and people who actually are iron-deficient need medical attention to ascertain why. (If, for example, the cause is intestinal bleeding from a curable cancer, delaying medical care could prove fatal.) In 1968 the FTC charged that TV commercials had misrepresented the likelihood that Geritol would relieve tiredness, loss of strength, rundown feelings, nervousness, and irritability. In 1975 the J.B. Williams Company of New York City settled the matter by agreeing to pay $125,000 in penalties to the government. The ad, to the right, which was published at about that time in Parade magazine, does not refer to fatigue or “tired blood” but was still misleading. Iron-deficiency anemia is not rare, but people who do not have this condition do not need iron supplements (see Chapter 17).
Historical Perspective
or better than those of their competitors. However, products described as “sustained-release,” “chelated,” “targeted,” “biologically activated,” “protein-bonded,” and “food-grown” are not significantly different from other products containing similar levels of ingredients. Some companies state that their supplement products are patented. The U.S. Patent Office does not require proof that a product actually works; the main requirement is that it be different from previously registered products. The 1994 Dietary Supplement Health and Education Act (DSHEA) permits product labels to carry “structure/ function” claims as long as the products are not falsely promoted for cure, mitigation, treatment, or prevention of disease. Manufacturers have responded by making hundreds of questionable claims that they previously were afraid to make. In December 1998, the FTC is- sued “Dietary Supplements: An Advertising Guide for Industry,” a detailed document to clarify the need for substantiation.34 The guide describes the steps the FTC uses to make its analyses and provides a road map for others who wish to do the same. To determine whether an ad complies with FTC law, the first step is to identify all expressed and implied claims that the ad conveys to consumers. Then the sci- entific evidence can be assessed to determine whether these claims are adequately supported. Advertisers must make sure that whatever they say expressly is accurate. Often, however, ads convey claims beyond those ex- pressly stated. Advertisers should not suggest claims that would be illegal to make directly. In addition, the
ad should be considered as a whole, assessing the “net impression” conveyed by all of its elements, including the text, product name, and depictions. For example, if an ad claims that “university studies prove” that a mineral supplement can improve athletic performance, the advertiser should have university-based studies that document the benefit as well as evidence that the studies are methodologically sound. And if an advertisement for a vitamin supplement claims that 90% of cardiologists regularly take the product, the advertiser should have adequate support for both the percentage and the implied representation that taking the product is beneficial for the heart. A statement about a product’s effect on a normal “structure or function” of the body may also imply that the product is beneficial for treatment. If elements of the ad imply that the product is useful against a disease, the advertiser must be able to substantiate the implied claim even if the ad contains no expressed reference to the disease. Thus if an ad for “Arthricure” shows an arthritic woman using a walker before taking the product and dancing afterward, the manufacturer should be able to substantiate the implied claims that the product can cure or mitigate arthritis. The FTC typically requires claims about the efficacy or safety of dietary supplements to be supported with “competent and reliable scientific evidence.” Anecdotal evidence about the individual experience of consumers is not sufficient to substantiate claims. Even if those experiences are genuine, the improvement may have
Part One Dynamics of the Health Marketplace56
the endorser and the advertiser of the product that the consumers would not reasonably expect. Claims based solely on traditional use should avoid implying that the product has been scientifically evalu- ated for efficacy.
resulted from factors unrelated to the supplement. In- dividual experiences are not a substitute for scientific research. Whenever an expert or consumer endorser is used, the advertiser should disclose any material con- nection (including payments or free products) between
nAturAlife herbAl PrOducts
If nature can heal itself, just think what it can do for you. . . . Just look at your body. Millions of little cells doing exactly what they’re supposed to do. Most of the time. Unfortunately, sometimes your body isn’t in perfect order. And that’s why people reach for synthetic drugs. The ques- tion is why? Doesn’t nature know your body better than anyone? That’s why there’s a Natural Pharmacy in food and drug stores near you. There you’ll find a new line of all-natural herbal supplements that have been considered healthful to the body for centuries. . . . What would your body rather have: something from a laboratory, or some- thing from nature? Analysis: The key question should not be whether products are “natural,” where they are made, or whether they have been used for centuries as folk remedies. The important issue is whether they have been proven safe and effective for their intended purpose. Most herbal products have not (see Chapter 11).
cAncer treAtment centers Of AmericA
We specialize in treating cases others call “hopeless,” cases in which previous treatments have often failed. . . . People fighting for a chance to live. We’ve given them the chance, time and again. . . . And we’ve done it without the side effects that can make other cancer treatments unbearable. One reason, we’re certain, is our love-filled environment. Another is the quality and the scope of our cancer treatments. Analysis: Is there a way to determine whether this hospital offers superior treatment? Have its results been published in a peer-reviewed scientific journal or anywhere else? If effective chemotherapy could be administered without side effects, why wouldn’t every facility use it?
Pure flOridA OrAnge juice
After reading how research has found that certain nutri- ents like those in 100% pure Florida orange juice may help prevent some types of cancer (when part of low-fat, high-fiber diets rich in fruits and vegetables), Mr. Johnson, known for his frugality, finally relented to his employees’ demands and improved the company’s health plan. Analysis: The ad, from the Florida Department of Citrus, pictures “Mr. Johnson” standing next to a water cooler filled with orange juice. Diets rich in fruits and
vegetables are associated with a lower incidence of cancer, but no one knows what dietary components produce this effect. Orange juice is high in vitamin C—as are potatoes, tomatoes, and broccoli—but any diet rich in fruits and vegetables is likely to provide more vitamin C than people need. Drinking orange juice instead of water is unlikely to lower the incidence of cancer for anyone whose diet is otherwise balanced.
medicine frOm nAture
Unlike most over-the-counter medicines, Medicine from Nature works in harmony with your own body defenses and gets to the cause of your illness or discomfort. So rather than masking the symptoms of a cold . . . your body gets the support to work through the problem on its own. The result is no side effects, only relief. Analysis: This message was used to promote a large line of homeopathic remedies, which, according to the ad, enhance the body’s self-healing ability. Is this a testable claim? Has it been tested? Do you think that any medi- cation potent enough to benefit people can have a zero incidence of side effects? Actually, most homeopathic “remedies” are so dilute that they exert no detectable effect on the body (see Chapter 8).
ensure And ensure high PrOtein
Even if you’ve improved your diet by eating more lean meats, fruits and vegetables, you still may not be getting the balanced nutrition you need. So how can you help guarantee that you and the ones you love get the right nutrition? With Ensure and Ensure High Protein. Ensure is more than a vitamin supplement. It’s complete, balanced nutrition in a delicious ready-to-serve drink that provides an excellent balance of protein, carbohydrate, vitamins and minerals. . . . Ensure is even recommended #1 by doctors as a complete source of nutrition. Analysis: Doctors recommend these products for people whose appetite is impaired, usually as a result of severe illness or major surgery. They are not recommended for the general population. They contain significant amounts of vitamins and minerals but lack fiber, certain trace minerals, and many of the phyto-chemicals found in fruits and vegetables. There is no reason why young, healthy individuals (pictured in the ad) should waste their money on these products.
AnAlyses Of five Ad scriPts
Table 4-2
Chapter Four Advertising and Other Promotional Activities 57
When a claim, if unfounded, could present a substan- tial risk of injury to consumer health or safety, it can be held to a higher level of scientific proof. For example, a claim that a mineral supplement has been a popular American folk remedy for shrinking tumors should not be made without scientific evidence that the product is effective. An advertisement can also be deceptive because of what it fails to say. For example, if an herbal weight- loss product contains an ingredient that when regularly consumed can raise blood pressure, the advertiser should disclose this significantly potentially serious risk. When the disclosure of qualifying information is necessary, that information should be presented so that it is actually noticed and understood by consumers. A fine-print disclosure at the bottom of a print ad, a dis- claimer buried in a body of text, a brief text message in a television ad, or a disclaimer that is easily missed on a Web site are not likely to be adequate. Table 4-2 analyzes several ads. In 2009, the FTC sharpened its guidelines related to endorsements and testimonials, not just for dietary supplements but for all types of products.35 Now, if an advertisement features a consumer experience that is not typical, it must clearly disclose what consumers can generally expect. Previously, advertisers could describe unusual results as long as they included a disclaimer such as “results may vary.” Advertisers typically did this so inconspicuously that many people would not notice it. The new guidelines require disclaimers to be “clear and conspicuous.” Both advertisers and endorsers may be liable for false or unsubstantiated claims or for failure to disclose material connections.
mAil-Order quAcKery
Many people believe that advertising claims for health products must be true or somehow they would not be “allowed.” Many assume that media outlets screen such
ads carefully, and some even think that the Postal Service licenses mail-order advertisers. These beliefs are errone- ous. Several large studies have shown that the vast ma- jority of advertisements for mail-order health products are misleading. The names of people who respond to mail-order scams may even be added to “sucker lists” that are sold to other scammers. In 1991 the American Council on Science and Health (ACSH)36 published a study of magazines, tabloid newspapers, direct-mail catalogs, television infomer- cials, multilevel companies, and other channels through which health-related mail-order products are marketed. Table 4-3 lists products typically sold through these channels. The source materials included one issue each of 463 magazines in national circulation during the summer of 1990. Dubious ads appeared in 56 out of 423 (13%) gen- eral audience magazines and 23 out of 40 (58%) health and fitness magazines. In the general audience magazines 50 companies advertised about 70 dubious products. In health-food publications 15 companies advertised 24 dubious products. In fitness and bodybuilding magazines 26 companies advertised more than 60 questionable products. All but one product (a device for reducing sweat) were misrepresented. Tabloid newspapers (Globe, National Examiner, Sun, National Enquirer, and Weekly World News), which were surveyed for several months, contained several misleading ads per issue. ACSH’s report advised that no mail-order product can (a) cause effortless weight loss; (b) erase scars, wrinkles, or “cellulite”; (c) selectively reduce one part of the body; (d) increase bust or penis size; (e) prevent or cure hair loss; (f) increase stamina, endurance, strength, or muscle mass; (g) prevent aging; (h) prolong life; (i) prevent senility; (j) increase memory; or (k) increase sexual stimulation or pleasure. Figures 4-7 and 4-8 il- lustrate ads for such products. Table 4-3 indicates the typical channels through which dubious products are promoted.
figure 4-7. Photos from MuscleTech ads in Men’s Fitness magazine, January 2003. One ad stated that Hydroxycut has helped James Sterling lose 30 pounds. The other said that James gained 28 pounds in 8 weeks using MESO-Tech meal- replacement bars. Which should you believe?
Part One Dynamics of the Health Marketplace58
figure 4-8. Ads for mail-order health products.
Chapter Four Advertising and Other Promotional Activities 59
Weight-cOntrOl PrOmOtiOns
The $46 billion weight-control marketplace is rife with misleading ads for mail-order “diet” products, weight- loss clinics, spot reducers, cellulite removers, and similar products. The FDA has stated that there is no scientific or clinical evidence to support the use of body wraps or sauna suits for controlling weight. Nor are there any data to back up promoters’ claims that these products elimi- nate cellulite and bulging fat, make spot reductions pos- sible, control appetite, or increase the rate at which the body burns calories. Many ads for nonprescription “diet pills” refer to studies that supposedly back their claims. But such “studies” invariably are poorly designed, irrel- evant, or even nonexistent. For example, after pestering the marketer of Akavar 20/20 for six weeks, Dr. Harriet Hall received citations for two journal articles that did not describe tests of the product or its ingredients.37 Commercial weight-loss clinics have also been severely criticized. Weight-control facts and frauds are covered in Chapter 12.
yOuth And beAuty Aids Many products and services are falsely claimed to make people appear more youthful and attractive. In 1993, for example, Revlon, Inc. signed a consent agreement not to make unsubstantiated claims that its Ultima II ProCollagen anti-cellulite body complex would: (a)
significantly reduce cellulite; (b) help disperse toxins and excess water from areas where cellulite appears; (c) reduce skin’s bumpy texture, ripples, or slackness caused by cellulite; and (d) increase sub-skin tissue strength and tone.38 Chapter 18 provides additional information about bogus youth and beauty aids. The most aggressive promoter of youth and beauty aids was A. Glenn Braswell (1943–2006), whose Gero Vita International distributed about 20 million mail-order brochures per month during the late 1990s. Some of his products may have had some effectiveness (though overpriced), but most were promoted with misleading claims. Purchasers of any product were entitled to a free 1-year subscription (available separately for $39.95) to a monthly “journal” (Figure 4-9). Braswell was the object of 140 federal enforcement actions in the late 1970s and early 1980s and served a brief prison sentence for federal income tax evasion and perjury charges stemming from a mail-fraud investigation. But after his release he bounced back, grossed over $1 billion, and was even pardoned by President Clinton for his earlier crime. Ironically, the pardon may have served a useful purpose by causing regulatory agencies to give higher priority to Braswell’s illegal activities. In 2004, after having pleaded guilty to tax evasion and paying more than $10 million in back taxes, penalties, and interest, Braswell was sentenced to 18 months in prison. In 2005, Gero Vita, the “journal” editor, and a physician who had
Communication Channel Magazines, astrology Magazines, fitness/bodybuilding Magazines, general audience Magazines, health Magazines, health food
Magazines, pornographic Newspapers, general Newspapers, tabloid Classified ads Direct mail Prizes (mail or phone) Catalogs from mail-order supplement distributors Multilevel distributors
TV and radio infomercials
Internet
the mAil-Order heAlth mArKetPlAce
Table 4-3
Typical Products Psychic help with health problems “Ergogenic aids” Youth and beauty aids Nonprescription drugs sold through drugstores and supermarkets Herbs, homeopathic, and supplement products sold through health-food stores
Misleading claims tend to be made through articles rather than ads Sex aids Weight-reduction schemes Weight-reduction schemes, psychic healing Mostly information and product catalogs rather than specific products Weight-reduction schemes, anti-aging products, sex aids Vitamins, water purifiers A multitude of herbal and “dietary supplement” products with misleading therapeutic claims A multitude of supplement products with illegal claims made through brochures, videotapes, and word-of-mouth Weight-loss schemes, beauty aids, hair-loss remedies, “colon cleansers,” “parasite” removers, books, audiotapes, videotapes, and exercise devices All of the above—and much more
Part One Dynamics of the Health Marketplace60
endorsed products settled FTC charges by agreeing to pay a total of $605,000 and to refrain from making more unsubstantiated claims.39
exercise And fitness PrOducts
Public interest in exercise and fitness provides a steady stream of potential customers for products that are claimed to build muscles and enhance performance. “Ergogenic aids” that are concoctions of vitamins, minerals, and amino acids have been promoted through fitness and bodybuilding magazines. In 1985 the mar- ket leader, Weider Health and Fitness, signed an FTC consent agreement not to falsely claim that two of its products could help build muscles or substitute for anabolic steroids (see Chapter 13). Weider still markets these and similar products with testimonial ads featur- ing bodybuilding champions and other athletes. Many other companies use similar ads, and some advertise with blatantly false claims. Figure 4-10 illustrates how one company used imagery to deliver a powerful message that might be illegal if made explicit with words. The FTC has stopped many marketers from claiming that their exercise devices provide rapid weight-loss and body-shaping benefits. In 1999, for example, the FTC stopped Fitness Quest from claiming that several of its devices could cause the user to burn 1000 calories per hour and that using its “Ab Isolator” 3 minutes a day would result in a significantly reduced waistline in 30 days.40 In 2002, the agency charged that marketers of three electronic muscle stimulators (EMS devices) had
falsely advertised that users would get “six pack” or “washboard” abs without exercise.41 The FTC has also acted against misleading represen- tations by health and fitness facilities. These problems are discussed in Chapter 13.
PrOgrAm-length infOmerciAls
Many television programs that resemble talk shows are actually program-length commercials. Many such programs have promoted bogus weight-loss plans, hair-growth products, vitamin products, herbs, “skin rejuvenation” products, “body contouring” programs, cosmetics, exercise aids, books, DVDs, and other health- related products. Some of these programs use a movie star, athlete, or other celebrity as a host or guest, plus one or more “experts” who are referred to as “doctor.” Testimonials from “satisfied users” (some of whom are paid actors who have not used the product) also are a common feature. Further information about the products is available on Web sites operated by their sellers. One way to recognize an infomercial, says the FTC, is that the product promoted during “commercial breaks” is related to the program’s content. During the past decade the agency has filed many complaints against
figure 4-10. Ad from a bodybuilding magazine. The ad makes no claims, but a company catalog states that the product contains “mega doses of the vitamins and minerals normally required by strength athletes, fat metabolizers, branched-chain amino acids, complex carbohydrates, enzymes, and over 2000 milligrams of growth factors that can build a physique almost better than nature intended.”
I
Figure 4-9. This magazine, given free to buyers of mail- order health products, consisted of articles promoting the products’ ingredients.
Chapter Four Advertising and Other Promotional Activities 61
companies marketing infomercials. When necessary, the settlement agreements require that future program-length ads be clearly identified as ads throughout the program. Some infomercial producers have voluntarily inserted such notices in their ads. But many do not, and nearly all health-related products sold through infomercials are bogus.
multilevel mArKeting (mlm) Many companies market dietary supplements, diet plans, homeopathic products, herbs, and other health-related products through person-to-person sales, a process com- monly referred to as multilevel or network marketing. Almost anyone can become an “independent distribu- tor” by completing an application and paying a small fee (usually between $35 and $100) for a kit containing product literature and other sales aids. No knowledge of nutrition or health care is required. Distributors are urged to use the products themselves and to persuade others to become distributors who, in turn, use the products and recruit more distributors. With sufficient sales volume, distributors get a percentage of the sales in their “downline.” Companies suggest that this process provides a great money-making opportunity. The sales of health-related MLM products total several billion dollars per year. However, people who do not join dur- ing the first few months of operation or do not become one of the early distributors in their community have a very high probability of losing money.42 After analyz- ing data from 40 MLMs, Taylor43 concluded that 99.6% of participants spent more on operating expenses and company purchases than they received in commissions. In 2006, the FTC proposed a Business Opportunity Rule that would have forced MLM companies to disclose actual income potential to prospective distributors. But a vigorous lobbying campaign persuaded the FTC to exempt MLM companies from the rule.44
Most MLM health products are promoted through deceptive personal selling. Companies whose sales aids contain clear-cut health claims are easy targets for government enforcement actions. Some companies run this risk, hoping that the government will not act until their customer base is well established. Others make no claims in their “official” literature but rely on distribu- tors to supply anecdotes, testimonials, and independent literature. Distributors typically encourage people to try their products and credit them for any improvement that occurs. Many companies hold sales meetings at which people tell how products have supposedly helped them. Some sponsor telephone conference calls during which
distributors describe their financial success, give sales tips, and describe their own experiences with the prod- ucts. Testimonials may also be published in company magazines, audiotapes, and videotapes. Many distribu- tors use testimonials—typically their own—to market their products through computer bulletin boards and other Internet outlets. During the past 30 years Dr. Stephen Barrett has examined promotional materials from more than 250 multilevel companies selling health-related products. Every single one has made false or misleading claims. The products that have nutritional value (such as mul- tivitamins and low-cholesterol foods) are invariably overpriced and usually not needed. Those promoted as remedies are either bogus, unproven, or intended for conditions that are unsuitable for self-medication.42 The FTC, the FDA, and a few state attorneys general have taken enforcement action against more than 30 MLM companies that made misleading health claims.45
Today’s most noteworthy MLMs include the following. Herbalife, which has marketed purported weight- loss products for many years, is promoting Niteworks for preventing cardiovascular disease. At a 2003 com- pany extravaganza, UCLA professor Louis J. Ignarro, Ph.D., who shared the 1998 Nobel Prize in Medicine, claimed that the product will result in “no more heart disease.” The product contains vitamin C, vitamin E, arginine, and citrulline, a combination that Ignarro says will protect against cardiovascular disease by increasing the amount of nitric acid available to the cells that line artery walls. In 2004, a journal article he co-authored concluded that giving arginine plus vitamins C and E decreased the amount of heart disease in mice with high cholesterol levels.46 Although mouse studies should not be extrapolated to humans, and although Niteworks has not been tested in humans, Ignarro has told Herbalife distributors that the product can substitute for prescrip- tion drugs. When Ignarro submitted the journal article, he failed to disclose that his consulting firm gets a 1% royalty on sales.47 After this omission came to light, the journal reported the connection but did not mention that $1 million had already been paid. In 1986, the California Attorney General obtained an injunction that prohibits Herbalife from making unsubstantiated health claims for any of its products. The promotion of Niteworks appears to violate this injunction as well as federal laws against the marketing of unapproved new drugs.48
Ideal Health International advertises that its custom- made nutritional supplements provide a rational way to ensure getting “a daily supply of high-quality nutrients your body needs to function at its best.” The company’s program is centered around its PrivaTest, a urine test
Part One Dynamics of the Health Marketplace62
it claims will “uncover your nutritional status and metabolic trends” and “find out how well your body is using the nutrients you are eating.” In 2004, the test cost $79.95 and the “customized” vitamins (called Custom Essentials) retailed for about $50 plus shipping. Neither the PrivaTest nor the nutrients that the company markets offer good value. Urine tests do not provide a legitimate basis for recommending that people take dietary supplements. Moreover, even if they could, the nutrients in the so-called customized formulas can be obtained far more inexpensively in retail stores.49 In 2009, Donald Trump, whom many Americans associate with good entrepreneurial judgment, partnered with Ideal Health’s founders and the company was renamed The Trump Network. In a video on the company’s Web site, Trump stated that his plan was “designed to lead millions of Americans to better health and financial independence.” National Safety Associates markets Juice Plus+ products, which are made by extracting the vitamins and other phytochemicals from 17 fruits and vegetables. The products are claimed to be useful because diets high in fruits and vegetables are associated with lower rates of various diseases and many Americans fail to consume the recommended amounts. However, much of the pro- tective effect of fruits and vegetables is probably due to their fiber content. Juice Plus+ pills have nearly all the fiber removed.50
telemArKeting schemes
Fred Schulte,51 a newspaper editor who spent more than 1 year investigating telemarketing schemes, concluded that millions of people had been robbed at an annual rate of more than $40 billion. The health-related schemes typically involved notification by mail or phone that the recipient had won a “valuable” prize. To collect, the recipient would have to buy a large supply of vitamins,
a water purifier, or something else that cost hundreds of dollars. If delivery were made, the prize almost always was worthless, the product overpriced, and the “money- back guarantee” not honored. When a product is ordered by credit card, the buyer can usually prevent loss by asking the credit card com- pany to reverse the payment. But many buyers don’t realize this or waste so much time trying to get a refund that the deadline for action (usually 60 days) through the credit card issuer expires. In response to this burgeoning problem, state and federal agencies took action against hundreds of indi- viduals and companies. A 1992 nationwide undercover investigation called Operation Disconnect resulted in 296 convictions and the seizure of $7.6 million in fraudu- lently obtained assets. Another major effort was Opera- tion Sentinel, in which volunteers trained at seminars run by the American Association of Retired Persons helped the FBI and the Justice Department gather evidence used in 1996 to arrest more than 400 fraudulent telemarketers in 15 states. The FTC advises consumers to report suspect tele- marketing activities to their state attorney general and the National Fraud Information Center (1-800-876-7060). The 1993 Telemarketing and Consumer Fraud and Abuse Prevention Act enables state attorneys general to use federal courts to stop scams nationwide. In 2003, the FTC launched the National Do Not Call Registry (www. donotcall.gov) to help curb unsolicited telemarketing calls at home. A few months later, a Harris poll found that 92% of registrants said they were receiving fewer calls, and 78% said they were getting “far fewer calls” or none at all.52
industry self-regulAtiOn
In 1971, when the FTC was initiating an advertising substantiation program, the National Advertising Review Board (NARB) was formed “to promote higher standards of truth and accuracy in national and regional advertising.” Its sponsors were the American Advertising Federation, American Association of Advertising Agencies, Association of National Advertisers, and Council of Better Business Bureaus. The review process is done primarily by the Council’s National Advertising Division (NAD), which investigates questionable ads, draws conclusions, and sometimes negotiates settlements. Parties that disagree with NAD’s findings can appeal to the NARB. Few cases go to the NARB. NAD may initiate action as a result of its own monitoring of the advertising media. Complaints are also made by competing companies, local Better Business
Treat all health-related ads or would-be ads with skepticism and never make an investment or purchase decision based solely on information obtained from a single source in any medium—print, broadcast, or online. Before responding to an ad, try to answer these questions:
• Is the product or service genuine? • Can it work as advertised? • Is it something I need? • Is a lower-priced alternative available?
√ Consumer Tip
Chapter Four Advertising and Other Promotional Activities 63
Bureaus, individual consumers, consumer groups, pro- fessional and trade associations, and government agen- cies. Anyone can initiate a complaint by sending a letter to NAD with a description of the ad (including a copy if it has been printed) and the reasons why it appears to be invalid. NAD is concerned only about nationally distributed advertising. When it decides to investigate a complaint, it asks the advertiser for substantiation, which is shown to the complainant for rebuttal. Closed cases are clas- sified in the monthly NAD Case Reports as “substanti- ated” or “modified or discontinued.” When a case is closed, a press release and detailed report are posted to NAD’s Web site, but access to its full reports requires a membership that is prohibitively expensive. If an errant advertiser persists, NAD will usually ask the FTC to act. NAD’s impact on the health marketplace is difficult to judge. Its investigations tend to be slow, and even ads that are discontinued as a result of an NAD inquiry usually have run long enough to achieve their purposes. In 2004, the Electronic Retailing Association began a similar program for infomercials and other types of direct response advertising.53 Since that time, it has persuaded many marketers to modify their advertising. However, its overall impact is difficult to judge because its adjudications receive little or no publicity and the supply of misleading infomercials seems endless.
regulAtOry Agencies
The FDA has jurisdiction over the labeling of foods, dietary supplements, drugs, and devices. The agency is fairly effective in keeping misleading claims off the labels of food products. But the Dietary Supplement Health and Education Act of 1994 has greatly increased the number of false claims made for supplement products and herbs and made it more difficult for the FDA to stop them (see Chapters 12 and 24). Since passage of this act, the FDA has turned down citizen petitions asking it to ban “stress vitamins” and “ergogenic aids” and issue public warnings that they are ineffective. The FTC has jurisdiction over the advertising of products and services except for prescription drugs. In recent years it has handled many health-related cases. The U.S. Postal Service has jurisdiction over prod- ucts marketed through the mail. However, it has not attempted to stop the sale of a fraudulently advertised mail-order health product since the early 1990s. State and local agencies have jurisdiction over adver- tising within their own state, but they vary considerably in their attitude toward health frauds. Some states handle many cases, whereas others handle few or none. When
a promotion is stopped in one state, it may be able to continue in others. In many cases more than one agency may have authority to act against a particular ad. Chapter 25 discusses the role of each of these agencies in detail. Consumers should keep in mind that the problem of health fraud is so vast that government agencies cannot stop most violations they detect.54
summAry
The health marketplace is flooded with misleading mes- sages. Some marketers use scare tactics to promote their wares. Some attempt to exploit people’s common hopes and fears. Many advertisers use puffery, weasel words, half-truths, or visual imagery to misrepresent their prod- ucts. Except for chiropractors, most health professionals who advertise tend to represent their services accurately. Ads by professional societies and hospitals also tend to be useful and informative. Although drug ads call attention to potentially useful products, their primary purpose is to sell rather than to inform. Food advertising tends to promote dietary imbalance. Dietary supplements and alleged weight-control products are promoted in a wide variety of misleading ways. Many ads for tobacco products have been intended to distract attention from their dangers. Health-related products promoted by mail, by telephone, by television infomercials, through the Internet, or through multilevel distributors rarely live up to the claims made for them. Although government agencies can stop many misleading promotions, regula- tory action provides only limited protection and cannot substitute for intelligent consumer behavior.
references
1. Kurtz P. The responsibilities of the media and paranormal claims. Skeptical Inquirer 9(4):362, 1985.
2. Miller R. Critiquing quack ads. FDA Consumer 19(2):10–13, 1985. 3. Lutz W. Doublespeak. New York, 1989, HarperCollins. 4. Pratkanis AR, Aronson E. Age of Propaganda: The Everyday
Use and Abuse of Persuasion. W.H. Freeman and Company, New York, 1992.
It’s Your Decision
A friend tells you he has been feeling extremely ener- getic since using product X. He thinks that everyone should use it. In fact, he is thinking about becoming a distributor for the company that makes the product. He invites you to try the product and to consider becom- ing a distributor. What things should you consider in making an intelligent decision?
Part One Dynamics of the Health Marketplace64
5. Preston IL. The Great American Blow-Up: Puffery in Advertis- ing and Selling. Madison, Wis., 1975, University of Wisconsin Press.
6. Razzouk NY. Marketing to the heart: A better cure for quackery. Presentation, San Bernardino, Calif., Jan 15, 2002.
7. Boush DM and others. Deception in the Marketplace. New York, 2009, Taylor & Francis Group.
8. DeBaggio T. Advertising image: Puffery or effrontery. The Nation 214:79–83, 1982.
9. Advertising Age, Dec. 7, 1981. 10. Barrett S, Herbert V. The Vitamin Pushers: How the “Health
Food” Industry Is Selling America a Bill of Goods. Amherst, N.Y., 1994, Prometheus Books.
11. AMA Council on Ethical and Judicial Affairs. Code of Medi- cal Ethics: Current Opinions with Annotations. Chicago, 2004, American Medical Association.
12. Barrett S. Be wary of the Lasik Vision Institute. Quackwatch Web site, Dec 7, 2003.
13. Federal Trade Commission stops allegedly misleading repre- sentations for Lasik eye surgery. FTC news release, March 26, 2003.
14. Illes J and others. Advertising, patient decision making, and self-referral for computed tomographic and magnetic resonance imaging. Archives of Internal Medicine 164:2415–2419, 2004.
15. Barrett S. Contour analysis is a marketing gimmick. Chirobase, Oct 11, 2001.
16. AHA management advisory: Ethical marketing by health care institutions. Chicago, 1992, American Hospital Association.
17. Gellad ZF, Lyles KW. Direct-to-consumer advertising of phar- maceuticals. American Journal of Medicine 120:475–480, 2007.
18. Brownfield ED and others. Direct-to-consumer drug adver- tisements on network television: an exploration of quantity, frequency, and placement. Journal of Health Communication 9:491-497, 2004.
19. Kessler DA, Pines WL. The federal regulation of prescription drug advertising and promotion. JAMA 264:2409–2415, 1990.
20. Year Two: A National Survey of Consumer Reactions to Direct- to-Consumer Advertising. Emmaus, Pa., 1999, Rodale Press.
21. Angell M. The Truth about Drug Companies. New York, 2004. Random House.
22. Mintzes B. For and against: Direct to consumer advertising is medicalizing normal human experience. British Medical Journal 324:908-909, 2002.
23. Lipman MM. Office visit: Pitching prescription drugs to con- sumers. Consumer Reports on Health 3:22, 1991.
24. Frosch DL and others. Creating demand for prescription drugs: A content analysis of television direct-to-consumer advertising. Annals of Family Medicine 5:6–13, 2007.
25. Frosch DL and others. A decade of controversy: Balancing policy with evidence in the regulation of prescription drug ad- vertising. American Journal of Public Health 100:24–32, 2010.
26. Kilbourne J. Still killing us softly: Advertising and the obses- sion with thinness. In Fallon P, Katz MA, Wooley SC, editors. Feminist Perspectives on Eating Disorders. New York, 1994, Guilford Press, pp 395–418.
27. Meister KA and others. Cigarettes: What the Warning Label Doesn’t Tell You. New York, 2003, American Council on Sci- ence and Health.
28. Wilson JJ. Summary of the attorneys general master tobacco settlement agreement, March 1999.
29. Riordan M. Tobacco company marketing to kids. Campaign for Tobacco-Free Kids Web site, Aug 2, 2011.
30. Polansky JR, Glantz SA. First-Run Smoking Presentations in U.S. Movies 1999–2003. Center for Tobacco Control Research and Education. Tobacco Control Policy Making: United States. March 9, 2004.
31. Bell RA and others. Frequency and types of foods advertised on Saturday morning and weekday afternoon English- and Spanish-speaking American television programs. Journal of Nutrition Education and Behavior 41:406–413, 2009.
32. Culp J and others. Characteristics of food industry Web sites and “advergames” targeting children. Journal of Nutrition Education and Behavior 42:197–201, 2010.
33. Kellogg settles FTC charges that ads for Frosted Mini-Wheats were false. FTC news release, April 20, 2009.
34. Bureau of Consumer Protection. Dietary Supplements: An Advertising Guide for Industry. Washington, DC, 1998, Federal Trade Commission.
35. FTC publishes final guides governing endorsements, testimo- nials: Changes affect testimonial advertisements, bloggers, celebrity endorsements. FTC news release, Oct 5, 2009.
36. Barrett S. Quackery by mail. New York, 1991, American Council on Science and Health.
37. Hall HA. Akavar 20/50 and truth in advertising. Science-Based Medicine Blog, Jan 22, 2008.
38. Revlon, Inc. to settle charges of unsubstantiated ad claims for “anti-cellulite” and sunscreen products. FTC news release, Aug 24, 1993.
39. Barrett S. Be wary of Gero Vita, A. Glenn Braswell, and Braswell’s “Journal” of Longevity. Quackwatch Web site, Oct 17, 2011.
40. Claims of weight loss for exercise gliders and abdominal de- vices not substantiated; FTC alleges. FTC news release, May 12, 1999.
41. FTC charges three top-selling electronic abdominal exercise belts with making false claims. FTC news release, May 8, 2002.
42. Barrett S. The mirage of multilevel marketing. Quackwatch Web site, Jan 1, 2008.
43. Taylor JM. The Case for and Against Multilevel Marketing: The Complete Guide to Understanding and Countering the Effects of Endless Chain Selling and Product-based Pyramid Schemes. Bountiful, Utah, 2011, Consumer Awareness Institute.
44. FTC proposes new Business Opportunity Rule. FTC news release, April 5, 2006.
45. MLM Watch home page, June 16, 2010. 46. Napoli C and others. Long-term combined beneficial effects of
physical training and metabolic treatment on atherosclerosis in hypercholesterolemic mice. Proceedings of the National Academy of Sciences 101:8797–8802, 2004.
47. Evans D. Nobel Prize winner didn’t disclose his Herbalife contract. Bloomberg News, Dec 6, 2004.
48. Barrett S. The dubious promotion of Herbalife’s Niteworks. MLM Watch Web site, Sept 23, 2010.
49. Barrett S. Ideal Health’s PrivaTest: Another scheme to sell you something. Quackwatch Web site, March 20, 2011.
50. Barrett S. Juice Plus: A critical look. Quackwatch Web site, Jan 27, 2008.
51. Schulte F. Fleeced! Telemarketing Ripoffs and How to Spot Them. Amherst, N.Y., 1995, Prometheus Books.
52. Are you getting telemarketing calls you don’t want? Here’s how to stop them. FTC consumer alert, May 2004.
53. Barrett S. The ERSP online complaint program. Infomercial Watch Web site, Feb 8, 2007.
54. Barrett S. Strength and weaknesses of our laws. Quackwatch Web site, Aug 15, 2001.
Science-BaSed HealtH care
The good physician treats the disease; the great physician treats the patient who has the disease. Sir William OSler
Historically in medicine, there was a paternalistic approach to deciding what should be done for a patient; the physician knew best and the patient accepted the recom- mendation without question. This era is ending, being replaced with consumerism and the movement toward shared decisionmaking. Patients are advising each other to “educate yourself and ask questions.” . . . Ready access to quality information and thoughtful patient–doctor discussions is at the fulcrum of this revolution. CarOl TeuTSCh, mD1 Knowing about your problem will help you assert yourself in the doctor’s office. And the more you know, the more intelligently you’re apt to follow—or question— your doctor’s advice. marvin lipman, m.D.2
“None of my friends could diagnose the symptoms, Doctor. You’re my last hope!”
© medical economics, 1983
Part Two Chapter Five
Part Two Health-Care Approaches66
• Good medical care should be a partnership between patient and practitioner.
• Great variations exist in the quality, distribution, and cost of health services. The best time to look for a suitable primary care physician or clinic is before you become ill.
• When seeking care, try to present an organized account of your present symptoms and relevant past history.
• The optimum frequency for periodic exams depends on age, health, lifestyle, and financial status. Complete physical examinations are not cost-effective for most people.
• The best protection against unnecessary surgery is a competent personal physician.
Keep tHeSe pointS in Mind aS You StudY tHiS cHapter
Key Concepts
S cience-based health care is the prevention, diag- nosis, and treatment of disease based on modern scientific principles. Most people in the United
States accept physicians as the primary health authori- ties. Aligned with them are other scientifically trained practitioners and ancillary (allied) providers who es- pouse scientific concepts of disease. Science-based pro- fessions modify their standards of practice in response to new knowledge from important research developments. They also advocate strict ethical codes and rigorous procedures for education, licensure, and accountability. This chapter discusses the training and work of medical and osteopathic physicians, podiatrists, nurses, and various allied personnel. Mental-health, dental, nutrition, sports medicine, pharmacy, and optometry professionals are discussed in Chapters 6, 7, 10, 13, 17, and 20, respectively.
HealtH-care perSonnel
Most health professions are regulated by state licensing laws. To become a licensed professional, one must first complete a specified amount of training at an accredited institution and then pass a licensing examination. In many states practitioners must participate in continuing education to maintain their license and/or their member- ship in their professional association. Based on laws that define their scope of practice, practitioners may be divided into three groups:
1. Independent practitioners whose scope and authority are broad: medical and osteopathic physicians.
2. Independent practitioners whose scope is limited: dentists, podiatrists, optometrists, psychologists, and dietitians.
3. Ancillary providers, most of whom practice under some degree of medical supervision or control: nurses, physi- cians’ assistants, physical and occupational therapists, pharmacists, and many types of technicians.
Practitioners may also be classified according to whether or not they provide primary care, which the Institute of Medicine defines as “the provision of in- tegrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.”3 Primary health-care provid- ers include family physicians, most pediatricians, some internal medicine specialists, some gynecologists, some physician assistants, and some nurse practitioners. Medical Doctors The doctor of medicine (M.D.) degree requires 4 years of training at a medical school accredited by the Liaison Committee on Medical Education, which is sponsored by the American Medical Association (AMA) and the Association of American Medical Colleges (AAMC). The first 2 years of medical training cover basic and preclinical science courses, including anatomy, physiol- ogy, biochemistry, histology, pathology, epidemiology, and pharmacology. The last 2 years stress clinical work in hospital and clinic settings. Nearly all matriculants have at least a baccalaureate degree. There are 131 accredited medical schools in the United States.4 Graduates of these schools must take state or national board examinations to become licensed. All states require at least 1 year of additional postgraduate training at a hospital. Foreign medical school graduates must pass a special exam and complete 1–3 years of postgraduate training. Currently there are about 700,000 medical doctors in the United States, about 250,000 of whom are AMA members. Because modern medical knowledge is so vast, nearly all medical school graduates take additional train- ing before entering clinical practice. Those choosing to become specialists take at least 3 years of residency
Chapter Five Science-Based Health Care 67
training during which they are designated as PGY 1 (postgraduate-year-one resident), PGY 2 (postgraduate- year-two resident), and so on. The recognized standard-setting organization is the American Board of Medical Specialties (ABMS). Established in 1933, it is composed of 24 primary medi- cal specialty boards and eight associate members: the Accreditation Council for Graduate Medical Education, American Hospital Association, AMA, AAMC, Council of Medical Specialty Societies, Education Commis- sion for Foreign Medical Graduates, Federation of State Medical Boards, and National Board of Medical Examiners. Medical specialty boards require high standards of training and performance and ensure them by rigid exam- inations. Successful applicants receive diplomas and are
considered “board-certified.” They are also referred to as “diplomates” in their particular specialties. Physicians who complete all requirements for certification except the examination may be identified as “board-eligible.” Certificates are now available for about 145 specialties and subspecialties. All require periodic reexamination for renewal, with most doing this every 7 or 10 years. Table 5-1 describes the scope of many of the recognized medical specialties and subspecialties.
Osteopathic Physicians The principles of osteopathy originally were expressed by Andrew Taylor Still, M.D., in 1874, when medical science was in its infancy. Still believed that diseases were caused by mechanical interference with nerve and blood supply and were curable by manipulation of
Colonial America had few trained physicians, no medical schools, and no standards of medical practice. Virtually anyone could practice medicine, but learning through apprenticeship was common. Much of the surgery was performed by barbers. In prerevolutionary America there were about 3500 practitioners, 400 of whom had obtained medical degrees from foreign schools. Many were immigrants. The first American medical school opened in 1765. Death rates were high during the eighteenth century. The major killers were infectious diseases, the causes of which were unknown. Cathartics and herbal concoctions were used for treatment. When purging was combined with bloodletting, many patients became so weak they died. During the nineteenth century, American medicine went from bad to worse. Many medical schools opened, but most had few if any standards of competence.5 Programs generally were 2 years long, with little scientific training, clinical instruction in hospitals, or laboratory work. In 1870 the head of the Harvard Medical School said that written examinations could not be given because most of the students could not write well enough.6 Dozens of schools sold diplomas, some for as little as $5. Many so-called healers were illiterates who peddled narcotic “cure-alls.” In the 1800s self-diagnosis and self-medication were practiced extensively. Most families had a supply of medical books, herbs, and nostrums. People who could nurse the sick were generally available, but doctors were seldom called. Few doctors were competent, patients lived considerable distances from physicians, and treatment
was often too severe. Many diseases that are now curable were simply accepted as “acts of God.” Few medicines used before 1900 were effective. Surgery often was successful, but postoperative infections exacted a heavy toll. For most ailments the best that could be done for the patient was to provide relief. Worthless nostrums were abundant, and charlatans flourished with- out interference from the law. Until the work of Louis Pasteur, Joseph Lister, and Robert Koch established the bacterial theory of disease in the 1870s, the cause of infections was unclear. Pasteur was a chemist who studied contagious disease in animals and discovered the anthrax bacillus. He also developed diphtheria antitoxin, rabies vaccine, and the theoretical basis for pasteurization. Lister used carbolic acid for an- tiseptic surgery. Koch discovered the bacillus that causes tuberculosis. By the 1880s infection-control measures were in- corporated into medical practice, and scientific methods for seeking medical facts were known. The groundwork had also been laid for consumer-protection laws based on the ability to determine whether claims are valid. In 1908 the American Medical Association and the Carnegie Foundation commissioned Dr. Abraham Flexner to investigate medical schools in the United States. His 1910 report recommended standards for curricula, admis- sions, and clinical teachings. The report, plus tightening of the requirements for medical licensure, led to the closing of half the schools. By the 1930s, schools that were not science-based were eliminated, accreditation procedures were established, and science-based health care was poised for explosive technologic growth.
Historical Perspective
The Rise of Medical Standards
Part Two Health-Care Approaches68
“deranged, displaced bones, nerves, muscles—remov- ing all obstructions—thereby setting the machinery of life moving.” Still’s autobiography7 states that he could “shake a child and stop scarlet fever, croup, diphtheria, and cure whooping cough in three days by a wring of its neck.” Still was antagonistic toward drug practices and regarded surgery as a last resort. Rejected as a cultist
by organized medicine, he founded the first osteopathic medical school in Kirksville, Missouri, in 1892. As medical science developed, osteopathy gradually incorporated all its theories and practices and abandoned Still’s teachings.6 Today, except for a slight additional emphasis on musculoskeletal diagnosis and treatment, the scope of osteopathy is identical to that of medicine.
allergy anD immunOlOgy: Management of asthmatic, allergic, immunologic, and related disorders
aneSTheSiOlOgy: Administration of drugs to prevent pain or to induce unconsciousness during surgical operations or diagnostic procedures
CarDiOvaSCular DiSeaSe (CarDiOlOgy): Subspecialty of internal medicine that deals with the heart and blood vessels
COlOn anD reCTal Surgery (prOCTOlOgy): Diagnosis and treatment of disorders of the lower digestive tract
DermaTOlOgy: Diagnosis and treatment of skin prob- lems
emergenCy meDiCine: Evaluation and treatment of emer- gencies
enDOCrinOlOgy: Subspecialty of internal medicine that deals with glandular and metabolic disorders
family praCTiCe: General medical services for patients and their families
fOrenSiC paThOlOgy: Subspecialty of pathology that deals with medicine and the law
gaSTrOenTerOlOgy: Subspecialty of internal medicine that deals with disorders of the digestive tract
general Surgery: Surgery that deals with parts of the body that are not in the domain of specific surgical specialties (some areas overlap)
geriaTriCS: Care of problems of the elderly; family prac- titioners and internists can become certified with added qualifications in geriatric medicine; psychiatrists can become certified with added qualifications in geriatric psychiatry
hemaTOlOgy: Subspecialty of internal medicine that deals with disorders of the blood
infeCTiOuS DiSeaSe: Subspecialty of internal medicine inTernal meDiCine: Diagnosis and nonsurgical treatment of internal organs of the body of adults
neOnaTal-perinaTal meDiCine: Subspecialty of pediatrics that deals with disorders of newborn infants, including premature infants
nephrOlOgy: Subspecialty of internal medicine that deals with kidney disorders
neurOlOgiC Surgery (neurOSurgery): Diagnosis and surgical treatment of diseases of the brain, spinal cord,
and nerves neurOlOgy: Diagnosis and nonsurgical treatment of dis- eases of the brain, spinal cord, and nerves
nuClear meDiCine: Use of radioactive substances for di- agnosis and treatment
ObSTeTriCS anD gyneCOlOgy (Ob/gyn): Care of pregnant women and treatment of disorders of the female repro- ductive system
OCCupaTiOnal meDiCine: Preventive medicine subspecialty that deals with work-related illnesses and injuries
OphThalmOlOgy: Medical and surgical care of the eye, including the prescription of visual aids
OrThOpeDiC Surgery (OrThOpeDiCS): Care of injuries and disorders of the muscles, bones, and joints
OTOlaryngOlOgy: Care of diseases of the head and neck, except for those of the eyes or brain
paThOlOgy: Examination and diagnosis of organs, tissues, body fluids, and excrement
peDiaTriCS: Care of children from birth through adoles- cence
phySiCal meDiCine anD rehabiliTaTiOn (phySiaTry): Treat- ment of convalescent and physically handicapped patients
plaSTiC Surgery: Surgery to correct or repair deformed or mutilated parts of the body, or to improve the appear- ance of facial or body features
prevenTive meDiCine (publiC healTh): Prevention of dis- ease through immunization, good health practice, and concern with environmental factors
pSyChiaTry: Diagnosis and treatment of mental and emo- tional problems
pulmOnary DiSeaSe: Subspecialty of internal medicine that deals with diseases of the lungs
raDiOlOgy: Use of radiation for the diagnosis and treat- ment of disease
rheumaTOlOgy: Subspecialty of internal medicine that deals with arthritis and related disorders
SpOrTS meDiCine: Subspecialty available to practitioners of internal medicine, pediatrics, family practice, orthope- dics, and emergency medicine
ThOraCiC Surgery: Surgical treatment of the lungs, heart, and large blood vessels within the chest cavity
Selected Medical SpecialtieS and SuBSpecialtieS
Table 5–1
Chapter Five Science-Based Health Care 69
Osteopathic physicians are licensed to practice in all states and are legally equivalent to medical doctors. The licensing boards vary in makeup: some are composed entirely of osteopaths, some are composed entirely of medical doctors, and some have both. Currently there are about 60,000 active practitioners and 30 accredited osteopathic colleges in the United States.8 The admission requirements and training are similar to those in medical schools. Graduation is followed by a 1-year rotating in- ternship at an approved teaching hospital. Specialization requires 2 to 6 additional years of residency training, depending on the specialty. A majority of osteopaths enter family practice. The American Osteopathic As- sociation (AOA) recognizes more than 60 specialties and subspecialties, Many observers believe that osteopathy and medi- cine should merge.9 But osteopathic organizations prefer to retain a separate identity and have attempted to capi- talize on the minor differences between osteopathy and medicine. For example, a 1987 AOA brochure stated that (a) osteopathy is “the only branch of mainstream medicine that follows the Hippocratic approach,” (b) the body’s musculoskeletal system is central to the patient’s well-being, and (c) osteopathic manipulative treatment (OMT) is a proven technique for many hands- on diagnoses and often can provide an alternative to drugs and surgery. The AOA’s Web site has claimed that (a) OMT “supports the body’s natural tendency toward healing,” (b) D.O.s offer a “unique approach to patient care. . . . They don’t just focus on symptoms,” and (c) combining OMT with all other medical procedures en- ables D.O.s to provide “the most comprehensive treat- ment available.” Such claims are false or misleading.10 Podiatrists Doctors of podiatric medicine (D.P.M.) are independent practitioners who deal with problems of the foot, ankle, and their related muscles and tendons. All states license podiatrists to provide surgical and medical treatment of the feet, including corrective devices, drugs, and physical therapy. Many podiatrists have hospital staff privileges, and many participate in group practice, health mainte- nance organizations, or other managed care programs. Podiatry has its roots in the practice of chiropodists, practitioners who treated corns, warts, bunions, and other ailments of the foot and hand. The terms “chiropodist” and “chiropody” became obsolete in the United States during the mid-1960s. Podiatric licensure requires a minimum of 90 semes- ter hours of undergraduate course work plus 4 additional
years of study at one of the eight accredited colleges of podiatric medicine in the United States. About two-thirds of the states require an additional year of postgraduate work. Residency programs for 1 to 3 years of additional training are available to graduates. There are about 15,000 podiatrists in the United States. About 90% are general practitioners, and the rest specialize in areas such as geriatrics, pediatrics, dermatology, surgery, orthopedics, public health, and sports medicine. The American Board of Multiple Specialties in Podiatry of- fers certification in primary care; podiatric surgery; and prevention and treatment of diabetic foot wounds. Nurses Registered nurses (R.N.s) are graduates of accredited nursing schools and have passed a state board examina- tion for licensure. Their education may be acquired in several ways. Two- and three-year programs leading to an associate degree are offered at community colleges or vocational technical schools. Three-year programs lead- ing to a diploma are offered at hospital-based schools of nursing. Four-year programs leading to a baccalaureate degree (B.S.N.) and 2-year entry-level master’s degree (M.S.N.) programs are offered by colleges and univer- sities. About 2 million registered nurses are licensed to practice in the United States. The primary certifying body for nurses is the American Nurses Credentialing Center (ANCC), a subsidiary of the American Nurses Association (ANA). Certification in more than 30 specialty and advanced practice areas is available to registered nurses who meet educational and practice requirements and pass an examination.11 In 2000, nurses with an associate or higher degree became eligible to acquire the credential “Registered Nurse, Certified” (RN,C); and those with a baccalaureate or higher degree may be eligible for the credential “Registered Nurse, Board Certified” (RN,BC). Registered nurses can work in hospitals, clinics, physicians’ offices, public and voluntary health agencies, schools, industries, or independent practice. Some states require additional training to work as a school nurse. Nurse practitioners are registered nurses who un- dergo additional nursing education at the master’s or doctorate level to enable them to function in many states as primary care providers. About half of the states permit this without physician supervision or collaboration.12 Nurse practitioners and clinical specialists can achieve certification as a clinical nurse specialist. They must have a master’s or higher degree in nursing, meet practice requirements, and pass an examination.
Part Two Health-Care Approaches70
Certification as an Advanced Practice Nurse entitles them to use the designation “APRN” or “APRN,BC.” Advanced practice nurses can work as nurse practitio- ners, certified nurse midwives, certified clinical nurse specialists, and certified nurse anesthetists. Certification is also available in nursing administration. Nurse anesthetists are R.N.s who have completed a 2-year program in anesthesia, usually at the master’s lev- el. Certified Registered Nurse Anesthetists (C.R.N.A.s) must pass an examination administered by the American Association of Nurse Anesthetists. Nurse-midwives are registered nurses who have completed an additional 1 to 2 years of training from an approved school of midwifery. By passing an examina- tion given by the American College of Nurse-Midwives (ACNM), R.N.s can earn a certified nurse-midwife (CNM) certificate that allows them to practice midwifery in all states. Nurse-midwives care for mothers during pregnancy, manage labor and delivery, and watch for signs that require a physician’s attention. They also help the mother care for herself and the baby and may serve as members of obstetric teams in medical centers and other community institutions. ACNM also offers certification to individuals in other health fields who graduate from an accredited midwifery education program and pass the same national certification examination as CNMs. These individuals are called certified midwives (CMs). Work as a public health nurse usually requires at least a baccalaureate degree. Specialization in public health may be acquired through nursing schools that offer a master of science (M.S.N.) degree. Many public health nurses have a master’s (M.P.H. or M.S.P.H) or doctoral degree (Dr.P.H.) in public health. The best schools for these degrees are accredited by the Council on Education for Public Health. Other doctoral-level degrees available to nurses include a Doctor of Nursing Practice (DNP or DrNP) degree for those interested in clinical practice and a Ph.D. for those interested in research or teaching. Practical and vocational nurses (L.P.N.s and L.V.N.s) are graduates of state-approved schools of nursing who must pass a state board examination for licensing. They usually work under the direction of a registered nurse. Their training usually takes 12 to 18 months. A high school diploma or equivalent is usually required for en- try, although some training programs accept candidates without a diploma or part of a high school curriculum. Table 5-2 describes the work of several other types of allied health-care personnel. Allied dental, mental health, nutrition, and optometric personnel are discussed in other chapters.
cHooSing a pHYSician
In the past, basic medical care of individuals and fami- lies was provided by family physicians. Typically they were general practitioners who did not limit themselves to one area of medicine. When a specialist was needed, the family physician remained as the primary contact and medical advisor, with the specialist serving as a consultant. As medicine became more complex, the percentage of physicians becoming specialists increased. As our society became more mobile, the number of group prac- tices and walk-in facilities increased, and more people consulted specialists without coordination and referral by a family physician. Lack of coordination raises the cost of care and may lower its quality. Many managed care plans attempt to counter this problem by requiring au- thorization from a primary care physician in order to consult a specialist (see Chapter 23).
The Good Physician Because of the complexity of medical practice, it is dif- ficult to construct yardsticks by which consumers can judge the quality of their medical care. In addition, what is good for one patient may not be what another needs or prefers. The “Consumer Tip” box lists qualities of a good physician.
A good physician: • Is intelligent and knowledgeable • Is sympathetic and interested in the patient • Advocates preventive measures • Is sufficiently organized to maintain a reasonably
smooth appointment schedule • Takes a detailed history and provides enough time
to discuss problems • After examination, provides a clear explanation of
the diagnosis and treatment • Knows his or her limitations and refers patients to
specialists when needed • Is conservative about recommending surgery • Will not abandon a patient once treatment has begun • Provides for appropriate telephone consultations • Is available for emergencies or provides competent
coverage • Charges reasonable fees and is willing to discuss
them • Is on the staff of an accredited hospital • Keeps up-to-date by reading journals and attending
educational meetings
√ Consumer Tip
Chapter Five Science-Based Health Care 71
More than 100 types of allied health-care personnel offer clinical services to the public.13-16 The AMA Committee on Allied Health Education and Accreditation accredits training programs for 26 occupations. Some types of allied health- care personnel are licensed; others are not.
auDiOlOgiSTS test patients and recommend hearing aids. A master’s degree is required, but the field is moving toward requiring a doctoral (Au.D.) degree.17
emergenCy meDiCal TeChniCianS (emTS) anD parameDiCS respond to medical emergencies and provide immediate care to the critically ill or injured. The National Registry of Emergency Medical Technicians (NREMT) regis- ters providers at five progressively skilled levels: First Responder, EMT-Basic, EMT-Intermediate/85, EMT- Intermediate/99, and EMT-Paramedic.18 First Responders are trained to provide emergency care. EMT-Intermediate workers are trained to administer advanced airway devices, intravenous fluids, and defibrillation devices. EMT-Paramedic training lasts up to 2 years and results in an associate degree in applied science with certification upon passage of an NREMT examination. Paramedics can administer drugs and use additional complex equipment under a physician’s order.
labOraTOry prOfeSSiOnalS include technicians and tech- nologists who perform a wide variety of tasks related to medical testing. They include pathologists’ assistants, medical technologists, cytotechnologists, histotech- nologists, histologic technicians, phlebotomists, medical laboratory technicians, and numerous laboratory special- ists. The American Society of Clinical Pathology offers certifications in 20 different categories and qualifications in three categories.13
meDiCal aSSiSTanTS work mainly in medical offices helping physicians to examine patients. They may also obtain laboratory specimens, function as receptionists, complete insurance forms, and order supplies. Their training may be a 2-year community college program, after which certification may be obtained from the American Asso- ciation of Medical Assistants or on-the-job training by physician-employers.
meDiCal SOCial WOrkerS help people with their jobs, fami- lies, financial problems, and daily living tasks, particu- larly when their needs are related to illness or disability. They usually have an MSW or DSW degree but some have a bachelor’s degree in social work.
nurSing aiDeS, also referred to as nursing assistants, hospital attendants, and orderlies, provide basic patient care under direct nursing supervision. They may bathe and feed pa- tients, change linens, and make beds. Most hospitals and nursing homes provide 6 to 8 weeks of on-the-job train- ing. Programs are also available at vocational schools, community colleges, and elsewhere. Aides who work in
nursing care facilities must complete a minimum of 75 hours of state-approved training and pass a competency evaluation; those who complete the program are known as certified nurse assistants (CNAs) and are placed on the state registry of nurse aides. Additional requirements vary by state.
OCCupaTiOnal TherapiSTS help physically and emotionally handicapped persons with vocational or recreational activities. A master’s or doctoral-level degree in occupa- tional therapy is required for entry into the field.
paTienT repreSenTaTiveS work mainly in hospitals, where they help patients interpret policies and procedures, respond to patient complaints, and help staff members understand how patients perceive the hospital experi- ence. Academic training is not required, although most are college graduates and a few have master’s degrees in health advocacy.
phySiCal TherapiSTS help to rehabilitate individuals who have temporary or permanent physical handicaps or other ailments. Their treatment methods include exercises to improve muscle strength, flexibility, and coordination and the application of physical modalities such as heat, cold, or electricity to relieve pain or to change the patient’s condition. A master’s or doctoral-level degree in physical therapy is required for entry into the field. Some states require physical therapists to work under physician super- vision, but most permit patients to access them directly.
phySiCian aSSiSTanTS (pas) perform many tasks traditionally done by physicians. PAs perform physical examinations, treat certain ailments, prescribe certain drugs, and counsel patients on health problems. Most PAs work in physi- cians’ offices, but some work in hospitals, health main- tenance organizations (HMOs), prisons, and community clinics. Training is available at programs accredited by the Accreditation Review Commission on Education for the Physician Assistant. PA programs take approximately 26 months and and require at least 2 years of college and some health-care experience prior to admission. All states regulate or license PAs. Licensure requires passage of an examination administered by the National Commission on Certification of Physician Assistants, which enables use of the title “Physician Assistant—Certified” (PA-C). To maintain national certification, PAs must complete 100 hours of continuing education every 2 years and pass a recertification examination every 6 years.19
reSpiraTOry TherapiSTS, on physician’s orders, treat patients with heart or lung problems, administering oxygen and various types of gases or aerosol drugs. They may also test respiratory function. Therapists complete a minimum of 2 years’ training in a college or trade school, after which they can take examinations for Certified Respiratory Therapist (CRT) and Registered Respiratory Therapist (RRT) credentials.
allied HealtH-care perSonnel
Table 5–2
Part Two Health-Care Approaches72
Alper20 suggests that marginal physicians can often be identified by overuse of antibiotics for common infec- tions, overuse of tranquilizers and injections, and use of “fad diagnoses” (discussed in Chapter 8 of this book). He states, for example, that antibiotic treatment is important for strep throats, but routine use for viral sore throats or ordinary colds is a sign of fuzzy thinking. Monthly B12 shots are lifesaving in cases of pernicious anemia, but giving shots to people who simply feel “rundown” is poor medical practice.
Locating Prospective Physicians Medical authorities recommend affiliation with a primary care provider—a personal physician who be- comes familiar with a patient’s medical needs and can coordinate care with other physicians, should consulta- tions become necessary. Ideally, primary care doctors generally offer “one-stop shopping” and lower cost and convenience. For many people the choice of physician is limited by the nature and scope of their insurance coverage. Student health services, for example, offer relatively few options. The following guidelines apply to the extent that a choice is possible. A board-certified family practitioner (for adults and children), internist (for adults only), geriatrician (for elderly adults), or pediatrician (for young children or adolescents) is likely to be a good choice because all of them have advanced training in the diagnosis and treatment of general medical problems. Staff affiliation with a hospital connected with a medical school usually indicates that a physician is working with up-to-date colleagues and is therefore likely to keep abreast of cur- rent medical developments. A teaching appointment at a medical school and affiliation with a hospital that trains residents are favorable signs. Lack of hospital affiliation is suspect because it may mean that the physician is isolated from the community’s scientific mainstream. Even worse, it could mean that the doctor’s standard of practice is not high enough to merit membership on a hospital staff. Regardless of affiliations, however, it is wise to avoid doctors who describe their practices as “alternative,” “complementary,” or “integrative” because most who do this offer unscientific care (see Chapter 8). McCall21 has pointed out that older doctors are more likely to fall behind, but those who make the effort to stay current combine their broad knowledge with a wealth of clinical experience. He also states that the best way to discover whether a doctor is up-to-date is to become well informed about subjects that concern you. Because a personal physician can significantly af- fect a person’s health (and even life), considerable care
should be exercised in looking for one. The best time to look is before becoming ill. Names can be obtained from many sources:
• The department of family practice or department of medi- cine at a nearby medical school
• A local accredited hospital • A local health-care professional such as a dentist, nurse, or pharmacist
• The county medical society (names are usually given out on a rotating basis from a list of available members)
• Friends, neighbors, co-workers • One’s physician from a previous community • A list of physicians participating in a managed-care program provided through one’s employer or otherwise available; some organizations hold meetings to introduce primary care physicians to new or prospective members.
The Washington Consumers’ Checkbook has sug- gested asking friends the following questions:
• Does your physician seem to understand your symptoms when you describe them?
• Does your physician take time to explain your medical problems and their treatment?
• Is it easy to talk with your physician about concerns, how- ever silly they may seem?
• How long do you usually have to wait for an appointment for a nonemergency medical problem?
• How long do you usually wait in the physician’s office? • Is it usually easy to reach the physician by phone? • Will the physician advise you on the phone? • Do the physician’s fees seem reasonable?
Another consideration that will become increas- ingly important is the use of electronic communication. Many medical offices will use the Internet to provide educational information and test results and to answer questions by e-mail. Credentials may be ascertained by contacting the physician’s office and may be verified by consulting a medical society, hospital, or managed-care program with which the physician is affiliated. They are also available online from the AMA (www.ama-assn.org) , the ABMS (www.abms.org), and many state licensing board Web sites. The most convenient way to access licensing board databases is through Internet Health Pilot (www. ihealthpilot.org/research/lookup.shtml). Most physicians identified as specialists in the Yel- low Pages have completed accredited specialty training. However, telephone directory publishers rarely attempt to verify credentials, so self-proclaimed specialists may be listed also. Board certification is easily checked on the American Board of Medical Specialties Web site at www.abms.org.
Chapter Five Science-Based Health Care 73
questions, and to judge the physician’s personality. If satisfied, one can also sign a release form to enable the new physician to obtain past medical records. Advance registration has another advantage. Some physicians will not accept new patients under emergency conditions, particularly outside of regular office hours. Once a patient is accepted, however, the doctor has a legal obligation either to treat the patient or to provide a substitute physician. Expectant parents may be able to schedule a get-acquainted visit with a pediatrician or family medicine physician at no charge. Most doctors are now in group practices and share coverage, and hospitalized patients are often followed by different group members or by doctors who are full-time hospital employees. However, if you prefer a particular local hospital, it is advantageous to choose a physician with privileges at that particular hospital. Having chosen a primary physician, medical group, or clinic, it is wise to try to learn about their routines. Most well-organized offices have printed information
Additional information is available from several commercial Web sites.22 Fee-based sites that provide information about training and disciplinary actions are generally accurate. However, neither fee-based nor free sites that attempt to rate doctors by assigning scores for credentials and experience or by posting reports from patients have been proven useful. The authors of this book have observed that some doctors rated highly by such sites are involved in quack practices.
Meeting the Physician An excellent way to begin a relationship with a new physician is to have an evaluation that includes a thor- ough physical examination. Such an examination will provide a baseline against which future changes can be compared. Those who do not wish to have a complete physical examination might still wish to schedule a brief “get-acquainted” visit with the prospective physician. This will provide an opportunity to observe the physical characteristics of the office, to bring up troubling health
From ancient times, physicians have recognized that the health and well-being of patients depends on a collaborative effort between physician and patient. Patients share with physicians the responsibility for their own health care. The patient-physician relationship is of greatest benefit to patients when they bring medical problems to the attention of their physicians in a timely fashion, provide information about their medical condition to the best of their ability, and work with their physicians in a mutually respectful alliance. Physicians can best contribute to this alliance by serving as their patient’s advocate and by fostering the following rights:
1. The patient has the right to receive information from physicians, and to discuss the benefits, risks, and costs of appropriate treatment alternatives. Patients should receive guidance from their physicians as to the optimal course of action. Patients are also entitled to obtain copies or summaries of their medical records, to have their questions answered, to be advised of potential conflicts of interest that their physicians might have, and to receive independent professional opinions.
2. The patient has the right to make decisions regarding the health care that is recommended by his or her physician. Accordingly, patients may accept or refuse any recommended medical treatment.
3. The patient has the right to courtesy, respect, dignity, responsiveness, and timely attention to his or her needs. 4. The patient has the right to confidentiality. The physician should not reveal confidential communications or infor- mation without the consent of the patient, unless provided for by law or by the need to protect the welfare of the individual or the public interest.
5. The patient has the right to continuity of health care. The physician has an obligation to cooperate in the coordination of medically indicated care with other health care providers treating the patient. The physician may not discontinue treatment of a patient as long as further treatment is medically indicated without giving the patient sufficient op- portunity to make alternative arrangements for care.
6. The patient has a basic right to have available adequate health care. Physicians, along with the rest of society, should continue to work toward this goal. Fulfillment of this right is dependent on society providing resources so that no patient is deprived of necessary care because of an inability to pay for the care. Physicians should continue their traditional assumption of part of the responsibility for the medical care of those who cannot afford essential health care. Physicians should advocate for patients in dealing with third parties when appropriate.
AMA Council on Ethical and Judicial Affairs (1993)23
Fundamental elements oF the Patient-Physician RelationshiP
Part Two Health-Care Approaches74
sheets for this purpose. If these are not available, ask questions about office hours, days off, coverage, house calls, and hospital affiliation. Knowing the hospital af- filiation is important because, in an emergency, unless instructed differently, ambulance drivers usually take patients to the nearest hospital, where your doctor(s) may not have staff privileges. Insured persons should also have a clear understanding of any rules related to specialist consultations, emergency department visits, or other matters that may affect whether a service is covered.
Emergency Care In an emergency, try to phone the doctor immediately rather than just showing up at the hospital emergency department. Advance notice may enable one’s doctor to provide the necessary service. It also will enable the doctor to alert the emergency department personnel so that they may begin treatment or arrange for necessary tests. Should an emergency arise before a doctor has been selected, the best bet is to go to the emergency depart- ment of the nearest accredited hospital. If a private practitioner is preferred, some emergency departments and medical societies maintain a roster of doctors who are on call 24 hours a day. If an ambulance is needed, one can be obtained by dialing 911 (or other community emergency number), contacting the police, or calling an ambulance company listed in the Yellow Pages of the telephone directory. Many cities have freestanding emergency centers, where fees are in between those of office practitioners and hospital emergency departments. The advantages and disadvantages of using such facilities are discussed in Chapter 22. Elderly or ailing individuals who live alone can wear or install special devices for emergen- cies; by pressing a button they can use these devices to signal that help is urgently needed.
Finding a Doctor Abroad Americans traveling in foreign countries can locate suitable treatment facilities through the International As- sociation for Medical Assistance to Travelers (IAMAT). Established in 1960, IAMAT is a voluntary organization of hospitals, health-care centers, and physicians who pledge to provide travelers with physicians who speak their language, meet IAMAT standards, and adhere to a fixed fee schedule similar to that in the United States. When medical assistance is needed, the traveler can tele- phone the nearest center listed in the IAMAT directory
to obtain a list of local physicians. The U.S. Centers for Disease Control and Prevention Web site (www.cdc. gov/travel) provides information on required vaccina- tions, prevention of foodborne diseases, and other tips for travelers.25
Advice from Remote Sources Advice is also available by telephone, by mail, and through the Internet. Many trustworthy agencies and groups operate toll-free hotlines and/or Web sites through which callers can obtain information or pose questions to knowledgeable parties. Some hospitals, organiza- tions, and individual practitioners sponsor phone lines through which consumers can select tape recordings on various topics. Several managed-care companies offer phone-based counseling performed by nurses, access to prerecorded information, or self-help publications. A few commercial services that are accessible through the Internet provide direct contact with physi- cians, pharmacists, or others who answer questions. The charges for such services are then billed to a credit card account or to one’s phone bill. Critics have warned that such advice has limited value because the person giv- ing it is unable to physically examine the caller. These services may provide useful information, but they are not suitable for personal diagnosis. Scientific studies concerning their quality and cost-effectiveness have not been published.
√ Consumer Tip
Emergency Information Persons who are subject to epilepsy, severe allergies, diabetes, or other ailments that may require urgent at- tention should wear a bracelet identifying the condition or carry an emergency medical identification card that lists the person’s name, next of kin, medical problems, medications taken, and doctor’s name. The technology now exists for posting detailed medical records on password-protected pages. Micro- soft Health Vault (www.healthvault.com) offers this service free of charge. The information can include the patient’s medical history, current medications, and hospital discharge summaries, as well as graphic images such as electrocardiograms and x-ray pictures. This in- formation could prove handy in an emergency or when a traveler is admitted to a hospital far from home.24 The access information can be carried in one’s wallet or on a bracelet.
Chapter Five Science-Based Health Care 75
BaSic Medical care
The belief that people should have regular health exami- nations has been popularized by the medical profession, and a large segment of the public in the United States regards an annual examination as advisable. The tradi- tional assumption has been that routine examinations can detect diseases in their early stages so that treatment can prevent suffering and save lives. However, complete annual examinations of symptom-free adults are not cost-effective. Consumers Union’s medical consultants26 have stated that a screening test should satisfy three basic requirements: 1. It should be able to detect a serious or potentially serious disease before symptoms make the individual aware that something is wrong.
2. There should be good reason to expect treatment that begins at that early stage to produce a better outcome than treat- ment begun after symptoms have appeared.
3. The procedure should be utilized by those most likely to benefit from it.
The prevailing medical opinion is that screening tests should be evidence-based and targeted to the individual patient’s risk factors. Scientific organizations may differ somewhat on the recommended frequency of certain periodic examinations, but all authorities agree that they are valuable, especially when combined with evaluation and counseling on nutrition, exercise, injury prevention, and other important aspects of a healthy lifestyle. The U.S. Preventive Services Task Force, which is discussed later in this chapter, has issued the most comprehensive guidelines.
History and Physical Examination A thorough health evaluation consists of four phases: (1) a medical history, (2) a physical examination, (3) clinical or laboratory tests, and (4) a report to the patient. It is likely to take 30 to 90 minutes and cost from $100 to more than $200 for the doctor’s time plus additional amounts for diagnostic tests. Internal medicine special- ists tend to charge more than family practitioners. The history should cover more than 100 detailed questions about past medical problems, current symp- toms, social and family history, and health habits. It is obtained most efficiently with a questionnaire completed by the patient (or parent) or administered by a member of the physician’s staff. Before the physician sees the patient, an assistant also measures height, weight, tem- perature, pulse rate, respiratory rate, blood pressure, and, sometimes, visual acuity. The physician then reviews the questionnaire and asks further questions.
A “complete” physical examination may include the following:
general appearanCe: Nutritional status and physical deformi- ties are noted.
eyeS: Appearance, movement, pupillary reflexes, and visual fields are checked. An ophthalmoscope is used to examine the insides of the eyes. A tonometer may be used to measure internal eye pressure.
earS: An otoscope is used to inspect eardrums and external canals. Hearing is tested with an audiometer.
nOSe: The inside is inspected for polyps or deviated septum. Oral CaviTy anD pharynx: Dental caries, tumors, and other indications of disease are noted.
neCk: Palpation is used to detect enlargement of lymph nodes or the thyroid gland. Veins are inspected for distention. A stethoscope may be used to listen for arterial murmurs.
lungS: A stethoscope is used to hear breath sounds. hearT: Pulse rate and rhythm are noted. Heart is palpated for abnormal rhythms. A stethoscope is used to check heart sounds.
breaSTS: Inspection and palpation are done to detect tumors. OTher lymph nODeS: Armpits and groin are palpated. baCk: Percussion with the fist may be used to detect kidney ten- derness. The spine is examined for abnormal curvature.
abDOmen: Deep palpation is used to detect tumors or enlarged organs such as the liver and spleen. A stethoscope is used to hear bowel sounds and arterial murmurs.
Skin: All parts of the body are examined for evidence of infec- tion, inflammation, cancer, or other skin problems.
Sex OrganS, male: Inspection, palpation, and a check for hernias are performed.
Sex OrganS, female: External genitalia are inspected. Cervix is visualized with a vaginal speculum. Uterus and ovaries are palpated with two gloved fingers inserted into the vagina and the other hand pressing on the abdomen.
reCTum anD anuS: Rectum and prostate (males only) are palpated with gloved finger. Anal area is inspected. Sig- moidoscopic examination may be performed.
legS: Varicose veins and swelling of the legs are noted. feeT: Pedal pulses are palpated. bOneS anD jOinTS: Swelling or deformities are noted. neurOlOgiC exam: Reflexes, strength, sensation, coordination, and mental status may be assessed.
Laboratory Tests and Procedures A complete blood count is commonly ordered as part of a routine physical evaluation. Whether other tests are or- dered varies according to the age of the patient, the style of the physician, the patient’s history, and the physical findings. The commonly performed tests include:
urinalySiS: The urine is tested for the presence of sugar, protein, cells, crystals, and other sediment. The presence of sugar might indicate diabetes. White blood cells might indicate infection. Red blood cells might indicate tumor or
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inflammation within the urinary system. Protein or other sediment may indicate kidney disease.
COmpleTe blOOD COunT: Hemoglobin is measured and red blood cells are examined to determine the presence of ane- mia. White blood cells are counted and examined to help diagnose various infections or leukemia. The platelet count is related to the ability of the blood to clot.
blOOD Sugar (gluCOSe) or hemOglObin a1C: Abnormal eleva- tions are a sign of diabetes (see Chapter 14).
blOOD lipiD prOfile: Measurement of total cholesterol, low- density lipoproteins (LDL), high-density lipoproteins (HDL), and triglycerides can help determine the risk of cardiovascular disease (see Chapter 15).
blOOD ChemiSTry SCreenS: Various tests are available to measure kidney function, liver function, certain enzyme activities, and many abnormal metabolic states. Computer- ized equipment can perform many tests at one time, often at less cost to the patient than a few tests done singly. One common test panel, a chemistry profile, typically has 24 components.
ulTraSenSiTive TSh: This blood test reflects the function of the thyroid gland. (TSH stands for thyroid-stimulating hormone.)
OCCulT blOOD: Feces may be examined for blood that is not ap- parent. Because bleeding can be intermittent, specimens are usually collected for 3 consecutive days. Positive results do not always indicate cancer; they may be caused by bleeding gums, use of aspirin or other nonsteroidal antiinflammatory drugs, a nonmalignant polyp, diverticulitis, hemorrhoids, or other conditions.
papaniCOlaOu (pap) TeST: This is primarily a screening test for uterine cervical cancer, but it may also indicate the presence of infection and the status of certain hormones. To do the test, cells obtained by scraping the woman’s cervix during a pelvic exam are placed on a glass slide and checked for abnormalities in the laboratory.
STD SCreening: Individuals who are sexually active and at high risk may be screened for HIV, chlamydia, or other sexually transmitted diseases.
eleCTrOCarDiOgram (eCg): This enables abnormal rhythms and certain other heart problems to be diagnosed by analyzing electrical patterns of the heart. Stress tests (ECGs performed during exercise) are discussed in Chapter 15.
Although screening tests provide considerable infor- mation at relatively low cost, they are not hazard-free. Minimal departures from “normal” can occur in healthy individuals, and “false positive” reports can result from errors in the testing or reporting procedures. These, in turn, may require further testing to assess whether they are truly significant. The Harvard Medical School Health Letter27 has observed:
The needless worry generated by an abnormal result, as well as the more expensive and sometimes risky diagnostic tests that are apt to follow, raises legitimate doubt about ordering
too many tests on healthy people. Nobody has yet devised a solution to the problem of having too much information.
Many tests are ordered because the doctor is afraid of missing something and being sued. Sometimes tests are ordered because the doctor fears that, without them, the patient will feel that not enough is being done. Financial considerations may play a role; it has been shown that doctors who own testing facilities are more likely to order tests than doctors who do not.
Frequency of Examinations Individual consumers must decide whether to invest in complete evaluations and how often to do so. Infants and young children should be checked annually. For symptom-free young adults, once every 5 years is reasonable. Complete examinations might be practical every 3 to 5 years after age 40, every 2 to 3 years after age 50, and annually after age 60. On the other hand, those who consult their physician several times a year for problems can achieve the equivalent of periodic complete examinations if their physician examines a few extra parts of the body during each visit. This system can be both effective and economical. At specific ages, certain medical procedures have special significance because they may prevent problems or detect potentially serious problems that are treatable in their early stages. The U.S. Preventive Services Task Force (USPSTF) was created in 1984 to determine what types of periodic physical examinations, tests, immu- nizations, counseling, and other measures are science- based and cost-effective. Its work reflects the views of public health officials and hundreds of other experts about services intended to improve health outcomes. Updates to its recommendations are published on its Web site (www.uspreventiveservicestaskforce.org). Its latest (2010) comprehensive report28 contains more than 65 separate recommendations. Its overall advice includes:
• Effective interventions that address personal health prac- tices are likely to substantially reduce the incidence and severity of disease and disability. Preventive advice need not be confined to visits devoted entirely to prevention but can be dispensed during almost any visit.
• The clinician and the patient should share decision-making. Rather than having a uniform policy for all patients, doc- tors should educate their patients and consider individual preferences in deciding which interventions to recommend.
• Clinicians should be more selective in ordering tests and providing preventive services. Although certain tests can be highly effective in reducing mortality and morbidity, many others in common use have neither been proven nor disproven. The latter category includes screening tests
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for detecting diabetes, anemia, thyroid malfunction, and glaucoma in individuals who have no symptoms and are not considered to be at high risk.
The USPSTF’s specific recommendations vary considerably by age, risk factors, and health status. This chapter covers its guidelines for cancer screening, and other parts of the book discuss preventive strategies for cardiovascular disease and a few other conditions. Consumers who wish to delve into other USPSTF rec- ommendations can access them online. Some physicians treat problems as they arise and spend little time educating their patients about pre- vention. McCall21 has noted that if preventive advice and care are not incorporated into a doctor’s everyday dealings with patients, such care may never take place because many people only see a doctor when they are ill.
Cancer Screening Tests Because breast cancer is common, it is important for women to have periodic screening tests. The guidelines for the USPSTF are more conservative than those issued by the American Cancer Society (ACS) Mammography uses x-rays to examine the female breast. Recent improvements have resulted in much lower radiation doses and better detection ability. The ACS recommends that women age 40 or older undergo mammography every year. The USPSTF recommends it every 2 years from age 50 to 74. However, women whose sister or mother developed breast cancer before menopause should begin sooner, particularly if genetic testing results show changes in breast cancer susceptibil- ity genes (BRCA1 and/or BRCA2). Mammography involves brief discomfort when the breasts are compressed between plastic plates to permit maximum examination with minimum exposure to the radiation. This discomfort can be minimized by schedul- ing the test for the week after a menstrual period, when the breasts are their smallest and least tender. Breast self examination (BSE) has not been found to have an important role in detecting potentially life- threatening breast cancers early enough to make a dif- ference. However, doing BSE is one way for women to know how their breasts normally feel and to notice any changes.29 Testicular cancer, although much less common than breast cancer, is the most common cancer in males between the ages of 15 and 34. It is easy to detect and has a high cure rate, even though half the cases are not discovered until the cancer has spread beyond the testicles. The USPSTF30 has concluded that given the low prevalence of testicular cancer, limited accuracy of
screening tests, and lack of evidence that early detection leads to higher cure rates, the harms of screening exceed any potential benefits. The ACS31 recommends that all women begin cer- vical cancer screening about 3 years after they begin having vaginal intercourse, but no later than age 21. Screening should be done every year with the regular Pap test or every 2 years using the newer liquid-based Pap test. Beginning at age 30, most women who have had 3 normal Pap test results in a row may get screened (a) every 2 to 3 years with either the conventional or liquid-based Pap test or (b) every 3 years with one of these plus the human papilloma virus (HPV) test. After age 70, testing is unnecessary for women who are not at high risk and have \had 3 consecutive normal tests and no abnormal tests during the previous 10 years. Prostate cancer, the second most common cause of death from cancer among men, claims about 40,000 lives per year. Asymptomatic prostate cancer is very common as men get older (ranging from about 22% at age 50 to about 54% over age 80), and aggressive treatment has a high complication rate. Only a small percentage of these latent cancers progress to a point where they become a problem, however, and it is not known whether early detection and treatment actually save lives. A prostate-specific antigen (PSA) test and a digital rectal examination (DRE) can detect some cases of prostate cancer. However, additional diagnostic tests are expensive and uncomfortable, and treatment can cause erectile dysfunction, urinary incontinence, and other adverse effects. The USPSTF32 has concluded that PSA screening results in small or no reduction in death from prostate cancer and is associated with harms related to subsequent evaluation and treatments, some of which may be unnec- essary. All authorities recommend that if PSA testing is still considered, patients should be fully informed of the potential benefits and harm that can result from testing and subsequent treatment. Men should also be informed of the gaps in the evidence and helped in considering their personal preferences before deciding whether to be tested. Because most colorectal cancers arise in benign polyps, optimal screening programs seek to detect the polyps before they become cancerous. For people of av- erage risk, the ACS and USPSTF recommend—starting at age 50—colonoscopy every 10 years or flexible sig- moidoscopy, a double-contrast barium enema, or virtual colonoscopy every 5 years. More frequent examinations are recommended for people who have a family history of colorectal cancer or have had a polyp or other condi- tion that places them at higher risk.
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A sigmoidoscope is a slender, flexible, hollow, lighted tube about the thickness of a finger. It is inserted through the rectum up into the colon. This allows the doctor to look at the inside of the rectum and part of the colon for cancer or polyps. The sigmoidoscope may be connected to a video camera and video display monitor so the doctor can look closely at the inside of the colon. The test is sometimes uncomfortable but should not be painful. Because the instrument is only 60 centimeters (around 2 feet) long, the doctor can see about half of the colon. To prepare for the procedure, the patient admin- isters an enema to clean out the lower bowel. A colonoscope is similar to a sigmoidoscope but long enough to reach the full length of the colon, and the examination is done with intravenous sedation. To prepare for colonoscopy, the patient drinks a laxative solution that cleans out the entire large intestine. The barium enema examination is an x-ray proce- dure in which air and barium are inserted into the rectum to outline abnormal growths. Virtual colonoscopy (also called capsule endoscopy and video colonoscopy) is described later in this chapter. For individuals who are unable or unwilling to undergo one of the above procedures, the ACS recom- mends annual fecal testing for signs of bleeding within the intestine.33 Specimen-collection materials can be obtained from the office of a physician whose staff will perform the test when the specimens are returned. The recently developed fecal immunochemical test (FIT) appears to be superior to the guaiac test that has been used for many years.34 A digital rectal examination can detect abnormali- ties in the prostate and rectum, but it does not reach high enough into the colon to qualify as a stand-alone screening test for colorectal cancer.
Immunizations Immunizations should be part of routine health care obtained through one’s personal physician (or, in some instances, through a local health department). Long-lasting protection is available against measles; mumps; German measles (rubella); poliomyelitis; tetanus (lockjaw); whooping cough (pertussis); diph- theria; chickenpox (varicella); hepatitis A and B; and Haemophilus influenzae type b (HIB), a bacterium that can cause meningitis with death or neurologic damage to young children. Immunization against all of these is recommended by the American Academy of Pediatrics, the American Academy of Family Physicians, and the Advisory Committee on Immunization Practices of
the U.S. Centers for Disease Control and Prevention.35 Smallpox is now considered eradicated worldwide, so that vaccination is no longer given. Immunization against human papilloma virus (HPV) is discussed in Chapter 19. All states now require proof of immunization or other evidence of immunity against some of these dis- eases for admission to school. However, the requirements vary from state to state, and exemptions may be granted for medical, moral, or religious reasons. Keeping an im- munization diary will help to ensure that one’s protection is up-to-date. In recent years, various individuals and groups that promote unscientific practices have claimed that vac- cinations are unsafe. Chapter 14 debunks these claims. Immunization is also important for teenagers and adults. Those unprotected against any of the diseases just discussed (except HIB) should consult their physicians. A tetanus-diphtheria booster (called Td) should be ad- ministered every 10 years. Pertussis should be included in the booster (Tdap) administered to teenagers or to adults who did not have Tdap during their adolescence. Tdap is particularly important for people who will have close contact with newborn infants. Flu shots (which give only seasonal protection) and immunization against pneumococcal pneumonia are recommended for high-risk patients, elderly individuals, and certain institutional populations. The World Health Organization’s Global Polio Eradication Initiative has reduced the reported incidence of poliomyelitis from 350,000 cases in 1988 to about 2000 per year today, but immunization remains important in the United States to prevent a future outbreak.
Figure 5-1. CT scan shows a cross-section of the head with extraordinary anatomic detail.
(Photo courtesy of GE Medical Systems)
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Medical Imaging X-ray films can yield valuable diagnostic information. Cumulative exposure to ionizing radiation is potentially dangerous,36 however, so the possible benefits should be weighed against the risk involved in its use. In most cases the physician is in the best position to do this, but the following points may help patients avoid unneces- sary radiation:
• If the physician suggests x-ray films, the patient should understand why they are needed and whether the findings will influence the treatment recommendations.
• A lead-lined shield should be used to protect the reproduc- tive organs.
• When changing physicians, the patient should request that recent x-ray reports be sent to the new physician. It can also help to keep a list of one’s x-ray examinations, to avoid duplication and to help enable comparisons between current and previous films.
• The developing fetus is especially sensitive to radiation. X-ray films of the abdominal and pelvic regions of pregnant women should be postponed if possible, especially during the first 3 months of pregnancy. Some physicians prefer to avoid pelvic films during the last half of any menstrual cycle in case the woman is pregnant.
Advances in diagnostic scanning have enabled physicians to obtain a great deal of precise, detailed information about internal body structures. Computerized axial tomography uses an x-ray source that is focused on specific planes of the body and rotated to obtain pictures from multiple angles. The data are fed into a computer and processed to create a cross-sectional depiction of density that resembles a photograph. The procedure is commonly referred to as a CT scan or CAT scan. CT scans expose patients to much more radiation than plain x-ray films. However, when used selectively, they are invaluable and have replaced many invasive diagnostic procedures that were dangerous and often less reliable. Figure 5-1 shows a CT scan of the head. Conventional x-ray procedures and CT scans use a machine to generate and project x-rays through the body to produce a visual image. In radionuclide imaging, this set-up is reversed: radioactive chemicals are introduced into the body and taken up by various body structures. These structures then emit gamma rays that produce an image on a special camera outside the body. Radionu- clide imaging can detect tumors, infections, circulatory blockage, and other types of problems. The parts of the body commonly scanned are the bones, brain, heart, thy- roid gland, gallbladder, liver, kidneys, and lungs. Within hours or days, the radioactive substances lose most of their radioactivity or are excreted from the body.
Single photon emission computerized tomography (SPECT) is a specialized form of nuclear scanning that produces images similar to those of a CT scanner. Positron emission tomography (PET) combines the use of radioactive substances and computers to produce vivid color-coded pictures. PET scans are useful for evaluating the spread of cancers and for studying several other types of disease. They involve no ionizing radiation but are very expensive. Magnetic resonance imaging (MRI)—sometimes called nuclear magnetic resonance (NMR)—uses ra- diofrequency waves, a very strong magnetic field, and a computer to produce cross-sectional images. In some cases the picture can differentiate between adjacent soft tissues that might look the same on an x-ray film. To produce the MRI picture, the patient is exposed to a large magnetic coil. When the magnetic field is turned on, it causes hydrogen nuclei (protons) within the body to line up in one direction. Then selected radiofrequency waves flip these particles in another direction. When the waves are turned off, the particles realign, releasing an electromagnetic signal that the computer translates into an image. The technique involves no ionizing radiation, but it cannot be used with patients who have a pace- maker, metallic artificial joint, or other metallic implant.
Figure 5-2. Patient about to undergo MRI scanning. (Photo courtesy of GE Medical Systems)
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MRI devices can be open or closed. In the closed type, the patient lies inside a tunnel about 2 feet in di- ameter and 6 to 8 feet long. In the open type, the large magnet that generates the image is suspended a few feet above the patient and, except for its supports, the unit is open all around. Open MRI procedures are more com- fortable for some people but take longer to do and may be more expensive. Figure 5-2 shows a patient about to enter the tunnel of a closed MRI. Ultrasonography is done with a device that transmits sound waves through body tissues, records the echoes as the sounds encounter structures within the body, and transforms the recordings into a photographic image. No ionizing radiation is involved. The variety and useful- ness of diagnostic ultrasound procedures have increased rapidly. A few practitioners, mainly chiropractors, claim that spinal ultrasound enables them to follow the prog- ress of their treatment by detecting muscle inflammation or spasm. No published scientific study supports this contention. Chapter 20 discusses ultrasound use during pregnancy. Magnetic source imaging (also called biomagnetic imaging) uses a device that converts magnetic fields into electrical signals that are amplified and displayed on a computer screen for interpretation. It is used mainly for pinpointing abnormal brain function in epileptics and for diagnosing other disorders of the brain. The FDA has expressed concern about clinics that are offering full-body CT scans to look for warning signs of cancer, heart disease, and other abnormalities. Agency officials have warned that (a) many people will get false- positive results, leading them to seek additional tests or surgical procedures that may be risky and (b) the x-ray dosage from a CT procedure can be much greater than that of conventional x-ray procedures. CT scans can be extremely valuable when used appropriately, but there is not sufficient evidence to justify total body screening for patients without symptoms or a family history sug- gesting disease.37 For similar reasons, consumers should also be wary of other imaging tests marketed to the public without physician referral. Capsule endoscopy, which the FDA approved in 2001, is performed with a disposable capsule that con- tains a miniature color video camera, a light, a battery, and a transmitter. Images captured by the camera are transmitted to sensors attached to the patient’s torso and recorded digitally on a recording device that is worn around the patient’s waist. The test enables viewing of about 20 feet of the small intestine that cannot be effec- tively viewed with other tests. It provides a noninvasive diagnostic option for patients with Crohn’s disease,
celiac disease, intestinal tumors, and unexplained bleed- ing that cannot be pinpointed by other means.38
Surgical care
Surgery is defined as any operative or manual procedure for the diagnosis or treatment of a disease, injury, or deformity. Contemporary surgery in the United States is probably the best in the world. Improvements in pre- operative preparation, anesthesia, surgical techniques, high-tech equipment, and postoperative supervision have greatly reduced the discomfort and dangers that were a part of most operations in the past. But surgery should never be taken lightly. Any operation carries some risk, both from the surgical procedure and from the anesthetic. To be justified, surgery must be appropriate and the benefits must significantly exceed the hazards. This section provides general information about surgery and several types of operations. Coronary by- pass surgery (Chapter 15), cosmetic surgery (Chapter 18), therapeutic abortions (Chapter 19), and refractive surgery (Chapter 20) are discussed elsewhere.
Preparation for Surgery Surgical procedures can be categorized as emergency (as soon as an operating room is available), urgent (should be done within a few days), or elective (can wait from several days to several months). Contemplation of surgery should involve discussion of the patient’s health problem, the general nature of the operation, its risks and possible benefits, whether equivalent nonsurgical treatment is available, the type of anesthesia to be used, how much postoperative discomfort to expect, how and when normal activities can be resumed, and any allergies or other relevant health problems. It is also advisable to voice any special fears or concerns related to the surgery. Before surgery takes place, the patient (or a close relative if the patient is unable to do so) will be asked to sign a statement verifying that this information has been pro- vided. This “informed consent” discussion also provides an opportunity to assess the surgeon’s personality. The best safeguard in selecting a competent surgeon is probably referral by a primary care physician familiar with the surgeon’s work. If this is not available, or if further investigation is desired, the following questions suggested by Bradley39 may be useful:
• Are you board-certified in your surgical specialty? • Are you a Fellow of the American College of Surgeons? This credential, designated by the initials FACS, requires board certification, 2 years of community practice, and a peer-review process in which local surgeons judge the
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candidate’s ethics and personality and make first-hand observations of competence in the operating room.
• How many times have you performed the operation pro- posed for me?
• How do your results compare with those of other surgeons?
• What complications have you encountered, how often do they occur, and how do you manage them?
• Is the hospital equipped and staffed to handle a serious complication? Are consultations readily available?
Ambulatory Surgery Hundreds of different operations can be done in an outpatient setting. When appropriate, same-day surgery in a hospital outpatient facility, freestanding clinic, or doctor’s office can save time and money, prevent family disruptions, and reduce the psychologic stress of having an operation. To be suitable for outpatient surgery, one must be in good general health and have adequate help available for postoperative care at home. Ambulatory surgical facilities are discussed in Chapter 22.
Unnecessary Surgery During the early 1970s it was noticed that the number of operations performed was rising faster than the growth in population. Critics have charged that 10% to 20% of the operations performed annually in the United States are unnecessary. Criticism has been directed primarily against elective (not urgent) surgery, with hysterectomy; tonsillectomy; D&C; cesarean section; and back, knee, and prostate operations among the leading suspects. Studies by John E. Wennberg, M.D.,40 professor of epidemiology at Dartmouth Medical School, have shown that surgical rates are closely related to the density of surgeons and the number of beds in many communities. Dr. Wennberg has also noted that hospital admission rates for nonsurgical conditions can vary just as widely and that questionable local trends tend to decrease when studies are done. He believes that considerable research is needed to determine what practice patterns may be optimal. He also believes that it is preferable to use the term “unwanted variation,” which is defined as “care that is not consistent with the patient’s preference or related to the patient’s underlying illness.”41 One strategy to reduce the volume of unnecessary surgery has been to encourage or require patients covered by insurance programs to consult a second surgeon when elective surgery is recommended. Under these plans the second surgeon is not permitted to do the operation and thus has no possible financial incentive for agreeing that surgery is needed. Eugene McCarthy, M.D., professor of public health at Cornell University Medical Center, has
studied the effects of second-opinion programs on the rates of surgery and concluded that many operations were done unnecessarily. Others counter that disagreement by a consultant does not guarantee that an operation is unnecessary. Some insurance plans offer second-opinion coverage to their subscribers. Other strategies to reduce surplus surgery involve the development and publication of criteria that can be used to measure the appropriateness of surgery. The criteria can then be used for preoperative screening (a preventive measure) or for postoperative review, either of which can be performed by hospital committees or outside agencies. As managed-care and precertification programs have increased, the use of second-opinion programs has dropped sharply. Physician responsibility. Each hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations is required to maintain several active com- mittees of physicians to assess the quality of care at the hospital. A utilization review committee determines the appropriateness of hospital admissions and lengths of hospital stay, a tissue committee reviews operative work, and audit committees look for defective or un- necessary care. A physician whose work is judged to be substandard can have privileges curtailed or terminated. Nonaccredited hospitals may lack such committees. Patient responsibility. Although the ultimate re- sponsibility for preventing unnecessary surgery lies with medical experts, consumers can take a number of steps to protect themselves. If you need to consult a surgeon, preference should be given to one who is board-certified and on the staff of an accredited hospital. If surgery is recommended, a reasonable explanation of what it entails and why it is recommended should be sought. Ask whether a medical alternative is available and consider getting a second opinion from another surgeon. Alper20 suggests that if one’s primary physician has been selected with care, the physician’s opinion may be as valuable as or even more valuable than that of a second surgeon:
Capable personal physicians who are familiar with the surgeon’s work will not let their patients be stampeded into an unnecessary operation. They will ask the surgeon to justify the procedure to themselves as well as to the patient.
Gallbladder Surgery Most patients who have gallstones never develop symp- toms. For this reason, experts generally recommend against surgical treatment before symptoms appear, except for patients with an unusual x-ray finding that indicates a high risk of developing gallbladder cancer.41
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Authorities have also warned against routinely per- forming the operation on patients with symptoms that “might” be related to gallstones, but the relationship is not clear-cut.
Knee Surgery Arthroscopic washing and debris removal from the knees of patients with osteoarthritis are among the most com- monly employed orthopedic procedures. However, their effectiveness has never been proven in prospective trials, and a precise mechanism by which these procedures might help has not been established. The procedures involve making small incisions in the knee, inserting a thin instrument that allows the surgeons to see the joint, and then flushing debris from the knee or shaving rough areas of cartilage from the joint and then flushing it. In 2002, the New England Journal of Medicine43 published the results of a double-blind, randomized, placebo-controlled trial that compared washing, debris removal, and a sham procedure among male veterans with advanced disease. About 50 patients were in each group. Over a 2-year period, some patients felt better but there was no overall difference in outcome among the three groups. This suggested that the perceived benefits of arthroscopic washing and debris removal might be due to a placebo effect or the natural course of the condition. However, more research is needed to assess the outcome for other patient populations, and the results should not be used to judge other types of arthroscopic knee surgery.
Male Circumcision Circumcision has been practiced for religious reasons since ancient times and for health reasons for more than a century. In the United States most newborn males are still circumcised, although in recent years the rate appears to be falling. Circumcision may decrease the incidence of cancer of the penis, a rare condition that occurs almost exclusively in uncircumcised men. Poor hygiene and certain sexually transmitted diseases also correlate with the incidence of cancer of the penis. Circumcision can also help decrease the incidence of urinary tract infec- tions in young boys. The exact incidence of postoperative complications of circumcision (local infection and bleed- ing) is unknown but appears to be from 0.2% to 0.6%. The American Academy of Pediatrics44 has concluded:
Existing scientific evidence demonstrates potential medical benefits of newborn male circumcision; however, these data are not sufficient to recommend routine neonatal circumci- sion. In the case of circumcision, in which there are potential benefits and risks, yet the procedure is not essential to the child’s current well-being, parents should determine what is
in the best interest of the child. . . . It is legitimate for parents to take into account cultural, religious, and ethnic traditions, in addition to the medical factors, when making this decision. Analgesia is safe and effective in reducing the procedural pain associated with circumcision; therefore, if a decision for cir- cumcision is made, procedural analgesia should be provided. If circumcision is performed in the newborn period, it should only be done on infants who are stable and healthy.
QualitY oF Medical care
Most physicians are well trained and practice in an ethi- cal manner. However, there are valid concerns about the quality, maldistribution, and cost of health services. The problem areas include incompetence, impersonal care, sexual misconduct, malpractice, questionable creden- tials, and iatrogenic illness. Overutilization and other financial abuses are discussed in Chapter 23.
Incompetence Incompetence can be the result of drug addiction, alco- holism, mental illness, senility, or failure to keep abreast of new medical developments. The AMA has developed a model “impaired physician” law that has been adopted in some form by most states. The physician is first asked to seek help voluntarily. Next, hospital staffs are en- couraged to find ways to care for their errant colleague. Failing that, county medical societies must step in. If a physician is not attached to a hospital or medical society, the state licensing board must act. State medical societies in every state operate programs to rehabilitate impaired physicians. For example, in Georgia a committee of recovered alcoholic or drug-addicted physicians reaches out to problem physicians to offer a treatment plan. To keep abreast of medical developments, physi- cians talk with colleagues, read medical journals, attend meetings, and participate in other types of educational programs. Some authorities believe that continuing education should be formal and mandatory. Many states require a minimum number of hours per year for license renewal. Promiscuous use of injections may be a sign of incompetence. Some injections should not be given, and others should be used sparingly. For example, anti- biotics can usually be given by mouth, male hormones are unlikely to cure impotence, vitamin shots are not an appropriate therapy for fatigue, and cortisone injections into joints can cause long-term harm if given too often. The number of unfit and unethical physicians is unknown. During the past few years, the percentage of physicians using unsubstantiated diagnostic and therapeutic methods has risen significantly in response
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to misleading promotion of “alternative” and “comple- mentary” methods (see Chapter 8).
Impersonal Care Patients have a right to receive much more from physi- cians than mere attention to scientific therapy. Intelligent consumers want compassion and concern. They also want the right to participate in the treatment by knowing what is wrong and how it should be handled. It appears, however, that some physicians are more concerned with the number of patients they see than the quality of their interaction with patients. Such physi- cians may consider medical practice to be an episodic, impersonal affair. They spend little time with patients, attending to their immediate complaints in a rapid, me- chanical fashion without allowing time for questions or for complaints about other ailments. Rarely do they take the time to form a relationship and inquire about the patient’s lifestyle in order to suggest improvements of a preventive nature. Many physicians do not educate their patients suf- ficiently about treatment alternatives, drug side effects, and self-care. Many also fail to take cost into account when they prescribe drugs, order tests, or refer patients to specialists. With drugs, this can occur when a generic equivalent is available or when equally effective brand- name drugs differ in price. Occasional lateness is inevitable, but some physi- cians are habitually late in keeping scheduled appoint- ments. These doctors may attempt to justify their late- ness by stating that urgent cases and emergencies make their schedule unpredictable and that some patients take longer than expected. However, doctors can minimize waiting time by leaving room in their daily schedules for patients who must be seen on short notice or who need extra time. A well-trained receptionist can usually determine how much time is needed by asking the patient about the nature of the problem. If a doctor falls significantly behind schedule, pa- tients in the waiting room should be apprised of this so they can decide whether to wait, leave and return later, or reschedule for another day. Patients can do their part by scheduling extra time if they think their visit will require more than an average amount of time. Many years ago the Shawnee Mission (Kansas) Medical Center found a novel way to approach this problem. After surveys showed that their patients’ main complaint was wasting time in the waiting room, the doctors began lending beepers to those who wished to use nearby shopping facilities and be paged when the office was ready for them.45
The Essence of a Doctor? Reared in poverty, Freddie Brant quit school after the fifth grade. After four years in the Army during World War II he found that jobs were scarce for a man with only a fifth-grade education; so he joined the paratroops. In 1949, along with a fellow para- trooper, Brant was sentenced to seven years in the penitentiary for bank robbery. He began his “medical education” working in the prison hospital. After he was released, Brant continued his education by work- ing for four years as a laboratory and x-ray technician for Dr. Reid L. Brown of Chattanooga, Tennessee. There he picked up not only more medical lore but also the diplomas of his employer. Posing as Dr. Reid L. Brown, he obtained a license by endorsement and served for three years at a State Hospital in Texas. One day, while stopping at the village of Groveton, Texas, he treated the injured leg of a child. Groveton had long been without a doctor and its people were clamoring for medical care. “Dr. Brown” soon became established as the town physician and as a community leader. He might still be carrying on his thriving practice in Groveton, Texas, had he not run afoul of a computer. By co- incidence he ordered drugs from a pharmaceutical firm used by the real Dr. Reid Brown. Its computer gagged when it discovered orders on the same day from two physicians with identical names. Following an investigation, Freddie Brant was charged with forgery and with false testimony. Brant’s exposure caused great consternation in Groveton, but its citizens rallied around him. He was not convicted. A Chicago newspaper said that justice was thwarted because of a “lava flow of testimonials to the effect that Freddie Brant was a prince of a medical man, license or no license.” The paper said that the people of Groveton should have known that Reid Brown was not a doctor because he did too many things wrong. He made house calls for five dollars and charged only three dollars for an office visit. He approved of Medicare and would drive for miles to visit a patient, often without fee if the patient was poor. Besides, his handwriting was legible. What were the reasons for Freddie Brant’s suc- cess as an impersonator? The main ones were his readiness to refer any potentially complicated case to doctors in nearby towns, a personality that inspired confidence, and a willingness to take time to listen to his patients. Robert C. Derbyshire, M.D.46
Personal Glimpse
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Malpractice Every doctor makes mistakes. Those that are serious enough to cause damage may lead to malpractice suits. Contrary to popular belief, the physicians who are sued the most are not necessarily those who are incompetent. Top-notch specialists, who attract a high percentage of complicated cases, inevitably have many patients with unfavorable treatment outcomes. Such patients are more likely to file suit. Nearly all physicians carry malpractice insurance. Most hospitals require their medical staff to carry it, and some states require it for licensure. Fear of malpractice suits has caused most physicians to practice “.” This term refers to ordering tests that are not really necessary for medical purposes but may pro- tect the doctor from later being accused of negligently overlooking something. Following minor accidents, for example, x-ray films often are ordered for “legal reasons.”
Sexual Misconduct Sexual or romantic interactions between physicians and patients may exploit patient vulnerability, obscure the physician’s medical judgment, and ultimately be detrimental to the patient. The AMA Council on Judi- cial Affairs47 has concluded that (a) sexual contact or a romantic relationship with a patient concurrent with the physician-patient relationship is unethical and (b) any such relationship with a former patient would be unethi- cal if the physician exploits trust, knowledge, emotions, or influence derived from the previous professional relationship.
Questionable Credentials Many boards that are not affiliated with the ABMS or the American Osteopathic Association (AOA) have issued certificates to thousands of physicians. Although a few of these self-designated boards are run legitimately and may eventually achieve ABMS or AOA recognition, most do not require residency training in their specialty. Some states ban listing of such boards or require that any such listing mention that the board is not recognized by ABMS.
Iatrogenic Illness The word iatrogenic is derived from the Greek words iatros (physician) and genesis (production). It is broadly applied to any adverse condition produced in a patient as the result of diagnostic procedures or treatment. Dr. Ralph Greene,48 clinical professor of pathology at Northwestern University Medical School, noted that the incidence of iatrogenic illness keeps growing despite and
because of the growth of medical knowledge, technolog- ic advances, and the use of new drugs to treat previously incurable illnesses. His book Medical Overkill included the following points. Even though it was written many years ago, its conclusions are still valid.
• If people have enough tests, abnormal results that occur by chance may lead to extensive, expensive, and occasionally dangerous follow-up testing.
• Doctors sometimes order tests because they fear legal li- ability if they do not.
• All effective forms of treatment have the potential for troublesome side effects.
• New treatments may have unforeseeable adverse long-term consequences.
• Hospital-acquired infections are a serious enough prob- lem that hospitalization should be avoided whenever possible.
• Hospitalized patients should do as much as possible to avoid becoming the victim of a careless error. They should, for example, know the names and purposes of prescribed medications and know their blood type so they can check the labeling of blood being transfused.
• The patient’s best protection is to become well informed, to choose the most competent physician available, and to speak up when doubts arise.
Ethical Dilemmas Explosive progress in medical technology and increased emphasis on individual rights have raised troublesome new ethical questions and intensified old ones. Some examples follow. What is the value of life? Who is to decide when it shall start and when it shall stop? Should life be ter- minated when pain is great or if the cost of prolonging it places a heavy financial burden on the family or on society? To what extent should individuals determine whether their existence should be continued? Chapter 22 explores these questions. Should people have the right to sell their own body parts? Should surrogate motherhood be permitted? How should the use of scarce resources be allocated? Should surgical procedures costing tens or hundreds of thou- sands of dollars be financed by tax or insurance dollars? Should individuals who appear to be mentally ill but have not harmed anyone be hospitalized against their will? Can physicians determine who is dangerous and who is not? Should psychotic individuals be forced to take tranquilizers to improve their mental state if they do not want to? Does our society have adequate safe- guards so that nonconforming individuals and political dissidents are classified as mentally ill to restrict their freedom?
Chapter Five Science-Based Health Care 85
How confidential should medical records be? Should a family member be informed of a serious problem if the patient objects? How should our medical system handle extremely sensitive data, such as the results of AIDS tests or genetic tests that indicate a tendency toward cancer? Medical progress depends on experimentation. Who should be selected for experiments? Should people be allowed to volunteer as control subjects even if it means they may be deprived of an effective treatment? (This does not apply to new cancer treatments, which are tested by comparing them to older ones rather than to placebos.) Should institutionalized mental patients or prison inmates be allowed to volunteer? Can such people actually exercise free choice? Which should take precedence, producing and op- erating expensive equipment (such as kidney dialysis machines) for the benefit of a small number of persons, or upgrading basic medical care for a large number of underprivileged citizens? Many of these issues have been addressed by guidelines issued by the AMA23 and other professional organizations. Some (such entitlement to one’s own medical records) have been answered by state or federal laws and guidelines. Some hospitals have an ethicist or ethics committee that gives advice in specific cases.
tHe intelligent patient
Good medical care should be a partnership between patient and physician. The intelligent patient learns to consult a physician at appropriate times (see Chapter 14), makes careful observations when symptoms occur, communicates efficiently and openly, strives to under- stand the nature of any ailment and its treatment, and takes appropriate action if a grievance arises. McCall21 advises that “by making a habit of learning about every disorder you develop, every drug that’s prescribed, and every intervention that’s proposed, you get, in effect, a low-cost second opinion.” Effective Communication When consulting a doctor, try to present a detailed and well-organized account of present symptoms and relevant past history. Before contacting the doctor, it may help to draw up a list to guide your presentation. If there is more than one problem, start with the most important one. If you have a particular concern, bring it up at the beginning of your visit. If medications are being taken, either write down their names and dosages or bring the original bottles to the appointment. Since patients typically forget much of what they are told in a
doctor’s office, taking notes or utilizing a tape recorder (with the doctor’s permission) might be helpful.50 Physicians know much more about medicine than laypeople do but are not always good communicators. They may be authoritarian or even patronizing. Patients should not accept this behavior. Consumers have the right to be partners in their care and to receive a clear explanation of the physician’s findings and proposed treatment. There is no good reason why a physician can- not provide this. A friendly comment that you want to be able to follow the physician’s advice properly usually establishes the desired relationship. Emanuel and Emanuel51 have described four types of doctor-patient relationships. In the paternalistic model, the doctor decides what is best and the patient assumes this is correct. In the informative or consumer model, the doctor provides the facts, then the patient’s values determine what is done. In the interpretive model, the doctor helps to clarify the patient’s values and helps the patient select the medical interventions consistent with those values. In the deliberative model, the doctor promotes health-related values in addition to guiding the choice of interventions. The Emanuels believe that the consumer model “reduces the physician’s role to that of a technician” and that the deliberative model represents “the essence of doctoring” by physicians who really care about their patients. It is important that feelings of fear, embarrassment, or even resentment not be permitted to create a barrier between patient and physician. Put these feelings to good use by sharing them with the physician. Someone who fears an examination or is shy about body parts should say so. Discomfort during an examination is something else the physician wants to know about. If the physician
√ Consumer Tip
Consultations Diagnostic proficiency is directly related to the range and depth of the doctor’s experience with any particu- lar illness. If you’re informed you have a problem and that it is rare or unusual, one that appears serious or that involves a considerable amount of treatment or medication, you might want to ask your doctor the fol- lowing questions: • What is your experience with this problem? • Would a consultation be warranted with a doctor who has had more experience with this problem?
David R. Stutz, M.D.49 Bernard Feder, Ph.D.
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access to information about people who have applied for life or health insurance. A free copy of your record can be obtained annually through the bureau’s Web site at www.mib.com. Most health-care providers are bound by the HIPAA Privacy Rule, which provides patients with the right to access their medical records and limits who else can view them.53 The rule, which took effect in 2003, was generated by the 1996 federal Health Insurance Porta- bility and Accountability Act (HIPAA). The rule states, for example, that without the patient’s permission, it is illegal for health insurance companies to share medical information with entities such as mortgage compa- nies that could use the information to deny a loan and employers who might want to check medical records before hiring an employee. Violations can trigger civil and criminal penalties that range from $100 per incident to 10 years in prison and up to $250,000 in fines for obtaining protected information under false pretenses. The Privacy Rule does not cover Internet sites that seek personal medical information.
Telephone Tips Proper telephone use can do a great deal to make the physician’s life easier while helping the patient to receive better service. Before calling the office, take a moment to organize your thoughts. What is the problem? When did it begin? If there is a pain, does it come and go or is it steady? Does anything bring it on or relieve it? If there is an infection or any other reason to suspect a fever, take your temperature. Try to decide whether the problem is urgent. Before calling, write down a one- sentence description of your problem, your reason for calling, a symptom list, and no more than three questions that you may have. Most medical offices have a phone system that at- tempt to direct callers to the most helpful staff member. Receptionists and nurses are trained to assemble the information needed for a preliminary evaluation of the situation and usually know which matters to handle alone and which ones a doctor must handle personally. When dealing with a large clinic or hospital-based network, try to collect the direct numbers of any offices or depart- ments that you might call periodically. When you telephone, have a pad and pencil handy to write down any instructions. Human memory is notori- ously faulty. Call as early in the workday as possible. That way the physician can handle the problem most efficiently, because the physician’s assistants are on duty to help and hospitals and laboratories are able to give their best services. Some physicians offer e-mail access.
makes a sound or comment that causes concern, ask what it means. Don’t let fear or embarrassment stop you from mentioning a symptom or a problem that is bother- ing you. McCall21 suggests that if you wish to discuss something that you do not want to appear in your medical record, ask the doctor not to write it down. If in doubt about a diagnosis or treatment plan, discuss these doubts. If a particular treatment is ob- jectionable, the physician may be able to suggest an acceptable alternative. If necessary, a consultation with another physician should be requested. Similarly, if the physician suggests consultative action, the patient should appreciate this concern and be receptive to the proposal. Some consumer advocates recommend questioning doctors closely about the need for diagnostic tests and about alternatives to whatever treatment is proposed. However, challenging everything is likely to antagonize the doctor and could result in dismissal as a patient. The best approach is to select a doctor who makes sensible and cost-effective recommendations without prodding. Questions can then be used to enhance your understand- ing rather than trying to out-think the doctor. Be sure to have a clear understanding of fees in- volved. This matter is usually handled by the receptionist.
Access to Medical Records Some authorities believe that unlimited access to medi- cal records helps patients to become better informed and more involved in their care. Others believe that access should be limited when the records may contain informa- tion that could be misinterpreted or otherwise harmful. Many physicians use a large number of abbreviations, including some of their own, which could make many records incomprehensible to their patients (or even to other physicians). Some physicians concerned about con- fidentiality do not record information about alcoholism, drug abuse, or AIDS in the patient’s chart but keep it in a separate file to which only the physician has access. Most states have laws granting patients access to their records held by doctors and hospitals. A few man- date access to hospital records only. Most physicians readily furnish copies on request, except when they believe that a summary would be more meaningful. Johnson and Wolfe52 maintain: (a) any withholding of actual medical records is paternalistic, (b) checking one’s records may improve one’s understanding and may also reveal errors that could prove detrimental to insurance coverage, and (c) employers who self-insure may maintain a database with inappropriate access to employee medical records. The Medical Information Bureau provides about 470 insurance companies with
Chapter Five Science-Based Health Care 87
When calling for a prescription refill, know the phone number of the drugstore. Make the request during the doctor’s office hours and before you are down to the last pill. That way your office record can be reviewed to see whether the medication is still needed, whether the dosage should be changed, and so on. Such a review makes medical care safer. If you telephone outside of office hours, many physicians (especially those covering another’s practice) order only enough medication for a few days. That is the safest way in the absence of medi- cal records, but it does increase the cost of medication. Handling a Grievance If you choose a physician carefully and communicate effectively, it is unlikely that a serious grievance will develop. However, should you believe that a physician has overcharged for services or treated you in an incom- petent, unethical, or unprofessional manner, there are measures that can be taken. The grievance should first be discussed directly with the physician or a staff member. It may turn out to be based on a simple misunderstanding. Or it may be possible to negotiate a satisfactory resolution. If not, the next step could be a complaint to the local medical society. Some people hesitate to do this, thinking that “doctors will always stick up for each other.” Although physicians do have sympathy for each other, this feeling is balanced by an antipathy toward seriously unethical conduct, which reflects on the medical profession as a whole. Moreover, if similar complaints have been received, the society may already be suspicious.
If the physician is on the staff of a hospital, a com- plaint can also be made to the hospital administrator. Health maintenance organizations also have procedures for investigating complaints. Contacting the Better Business Bureau is unlikely to be effective because that organization ordinarily refers medical complainants to the local medical society. If these measures fail to resolve the concern, the next step should be a complaint to the state licensing board. Although the board will give priority to matters of incompetence, fraud, sexual misconduct, and drug abuse, it may also take action in less serious situations. If one believes a significant injury has resulted from negligence or carelessness, an attorney may be consulted to determine whether a malpractice suit is appropriate.
SuMMarY
Intelligent consumers should locate and use a primary care physician (or medical group) who provides care that is scientific, considerate, and compassionate. They should take an active role in dealing with health professionals. They should endeavor to understand the nature of any health problem they experience and the mechanisms and potential hazards of treatment. They should not hesitate to ask questions about fees or re- quest consultations for complicated problems. Good medical care should be a partnership between patient and physician. It should include preventive approaches and periodic examinations, as well as effective two-way communication.
reFerenceS
1. Teutsch C. Patient-doctor communication. Medical Clinics of North America 87:1115-1145, 2003.
2. Lipman M. Speak up to your doctor. Consumer Reports on Health 3:46, 1991.
3. IOM Committee on the Future of Primary Care. Primary Care: America’s Health in a New Era. Washington, D.C., 1996, Na- tional Academy Press.
4. Barzansky B. Medical schools in the United States, 2010–2011. JAMA 306:1007–1014, 2011.
5. Starr P. The Social Transformation of American Medicine. New York, 1982, Basic Books, Inc, Publishers.
6. Gevitz N. The D.O.’s: Osteopathic Medicine in America. Bal- timore, 1982, The Johns Hopkins University Press.
7. Autobiography of Andrew T. Still. Self-published, 1897. 8. Osteopathic medical profession report. American Osteopathic
Association, June 2009. 9. Gevitz N. Sectarian medicine. JAMA 257:1636–1640, 1987. 10. Barrett S. Dubious aspects of osteopathy. Quackwatch Web site,
Aug 18, 2003. 11. ANCC nurse certification. ANCC Web site, Aug 26, 2010.
It’s Your Decision
You are moving to a new community and want to find a competent physician, dentist, or other health profes- sional. What would you do? How would you know whether you have found the right person? When you visit a physician for a physical examina- tion, what should you expect it to include? What kinds of laboratory tests should be performed? Why? Should such an examination occur yearly? What should the cost be? What questions should you ask the physician about the findings of the examination? A doctor has advised you to have surgery (hernia repair, gallbladder removal, hysterectomy, or tonsillec- tomy) within the next few weeks. What action should you take to decide about the surgery?
Part Two Health-Care Approaches88
12. Harris G. When the nurse wants to be called ‘doctor.’ New York Times, Oct 1, 2011.
13. Procedures for Examination & Certification. ASCP Board of Certification, July 2010–December 2010. Chicago, 2010, American College of Clinical Pathologists.
14. Eldredge J, Buono D. 150 Careers in the Health Care Field. New Providence, R.I., 1993, U.S. Directory Service.
15. 300 Ways to Put Your Talent to Work in the Health Field. Wash- ington, D.C., 2002, National Health Council.
16. Occupational Outlook Handbook, 2010–11. U.S. Department of Labor, Bureau of Labor Statistics Web site Dec 7, 2009.
17. Audiologists. In Occupational Outlook Handbook, 2010–11. U.S. Department of Labor, Bureau of Labor Statistics Web site Dec 7, 2009.
18. Emergency medical technicians and paramedics. In Occupa- tional Outlook Handbook, 2010–11. U.S. Department of Labor, Bureau of Labor Statistics Web site Dec 7, 2009.
19. Certification process overview. NCCPA Web site, Aug 26, 2010. 20. Alper PR. Avoiding the “marginal” medic. In Barrett S, Jarvis
W, editors. The Health Robbers: A Close Look at Quackery in America. Amherst N.Y., 1993, Prometheus Books.
21. McCall TB. Examining Your Doctor: A Patient’s Guide to Avoiding Harmful Medical Care. New York, 1995, Birch Lane Press.
22. Barrett S. Physician credentials: How can I check them? Quackwatch Web site, Nov 19, 2009.
23. AMA Council on Ethical and Judicial Affairs. Code of Medical Ethics, 2004–2005 Edition. Chicago, 2004, American Medical Association.
24. Doyle DJ. Surfing the Internet for patient information: The personal clinical Web page. JAMA 274:1586, 1995.
25. Traveler’s health. Centers for Disease Control and Prevention Web site, accessed Aug 27, 2010.
26. Those costly annual physicals. Consumer Reports 45:601–606, 1980.
27. Bennett W. A primer on routine lab tests. Harvard Medical School Health Letter 10(12):4–6, 1985.
28. Guide to Clinical Preventive Services, 2010–2011: Recommen- dations of the U.S. Preventive Services Task Force. Agency for Healthcare Research and Quality, 2010.
29. Breast cancer. American Cancer Society Web site, accessed August 27, 2010.
30. Screening for testicular cancer. USPSTF Web site, April 2011. 31. Cervical cancer: Prevention and early detection. American
Cancer Society, June 23, 2011. 32. Chou R and others. Screening for prostate cancer. USPSTF Web
site, Oct 2011.
33. American Cancer Society recommendations for colorectal cancer early detection. ACS Web site, Nov 29, 2011.
34. Allison JE and others. Screening for colorectal neoplasms with new fecal occult blood tests: update on performance characteris- tics. Journal of the National Cancer Institute 99:1424-1425, 2007.
35. Immunization schedules. CDC Web site. Updated yearly. 36. Fazel R. Exposure to low-dose ionizing radiation from medi-
cal imaging procedures. New England Journal of Medicine 361:849–857, 2009.
37. Full-body CT scans: What you need to know. FDA Web site, accessed Jan 4, 2012.
38. Capsule endoscopy. Mayo Clinic Web site, July 17, 2010. 39. Bradley EL III. A Patient’s Guide to Surgery. Yonkers, N.Y.,
1994, Consumer Reports Books. 40. Wennberg JE. Variations in medical practice and hospital costs.
Connecticut Medicine 49:444–453, 1985. 41. Wennberg DE, Wennberg JE. Addressing variations: Is there
hope for the future? Health Affairs Web site, Dec 10, 2003. 42. NIH Consensus Conference. Gallstones and laparoscopic cho-
lecystectomy. JAMA 269:1018–1024, 1993. 43. Moseley JB and others. A controlled trial of arthroscopic surgery
for osteoarthritis of the knee. New England Journal of Medicine 347:81–88, 2002.
44. Task Force on Circumcision. Circumcision policy statement. Pediatrics 103:686–693, 1999, reaffirmed Sept 1, 2005.
45. Beeper-tagged patients roam till summoned. Medical World News, Feb 14, 1983.
46. Condensed from Derbyshire RC. The make-believe doctors. In Barrett S, Jarvis W, editors. The Health Robbers: A Close Look at Quackery in America. Amherst N.Y., 1993, Prometheus Books.
47. AMA Council on Judicial Affairs. Sexual misconduct in the practice of medicine. JAMA 266:2741–2745, 1991.
48. Greene R. Medical Overkill. Philadelphia, 1983, George F. Stickley Co.
49. Stutz DR, Feder B. The Savvy Patient: How to Be an Active Participant in Your Medical Care. New York, 1991, Consumer Reports Books.
50. How Is Your Doctor Treating You? Consumer Reports 60:81–88, 1995.
51. Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA 267:2221–2226, 1992.
52. Johnson D, Wolfe SM. Medical Records: Getting Yours: A Con- sumer’s Guide to Getting and Understanding Medical Records, ed 5. Washington, D.C., 1995, Public Citizen Publications.
53. Summary of the HIPAA Privacy Rule. U.S. Department of Health and Human Services, revised May 2003.
Mental and Behavioral help
It is easy to overlook the value of mental health until problems surface. Yet from early childhood until death, mental health is the springboard of thinking and communication skills, learning, emotional growth, resilience, and self-esteem. These are the ingredients of each indi- vidual’s successful contribution to community and society
U.S. SUrgeon general’S report on Mental HealtH1
The field of mental health has until recently shown surprisingly little interest in doing much about the problem of questionable science and pseudoscience that has long been festering in our own backyards.
Scott o. lilienfeld, pH.d2
Chapter Six
“How can I relax when I know this couch would look so much better in the opposite corner of the room?
Part Two Health-Care Approaches90
Although excellent help is available for mental and behavioral problems, obtaining suitable treatment can be difficult. There is a wide ar-
ray of practitioners, many of whom are incompetent. In addition, for economic reasons, many segments of our population cannot get adequate care.3 This chapter outlines the various types of practi- tioners, their treatment methods, and guidelines for distinguishing between proper and improper treatment. It also describes questionable self-help methods marketed to the public. Organizations that can provide additional information are included in the Appendix.
Who Should Seek help? Professional help is appropriate when a mental, emo- tional, or behavioral problem significantly interferes with someone’s ability to function, or when symptoms exceed an individual’s tolerance. The common problems for which help is advisable include:
depreSSion: persistent feelings of sadness or hopelessness, low self-esteem, frequent insomnia, loss of interest in activities, loss of appetite, weight loss, suicidal feelings
anxiety: intense anxiety that interferes with ability to function, phobias, panic attacks, psychosomatic disorders
rigidity: obsessive thoughts or actions, self-defeating behavior
iMpUlSivity: intense flightiness, periodic violent behavior, alcohol abuse and other addictive behavior
iMpaired Sociability: excessive shyness, socially inappropriate behavior, strong feelings of discomfort in social situations, abnormal dependency, generalized distrust of people
coping difficUlty: marital conflicts, parenting difficulties, school adjustment, prolonged grief reactions, excessive job stress
repeated failUre: an overall “batting average” in life that remains well below a person’s ability
Unreality: depersonalization (e.g., feelings that one’s body is changing in size), delusions (rigidly held false beliefs), hallucinations (e.g., hearing voices)
SUbStance abUSe: alcohol or drug abuse iMpaired Mental fUnction: impairment of thought processing,
judgment, memory, or other cognitive function
Mental health practitionerS Many types of practitioners profess to treat mental, emo- tional, and personal problems. The training, professional standards, and legal status of the different types vary considerably. This section briefly discusses many of the recognized credentials. The Credential Watch Web site (www.credentialwatch.org), which two of this book’s authors maintain, provides additional details. Psychiatrists are physicians (M.D.s or D.O.s) who have completed at least 3 years of specialized training in psychiatry after graduation from a medical or osteo- pathic school. Child psychiatrists have a minimum of 4 years of psychiatric training, including 2 years in adult psychiatry and 2 in child psychiatry. Geriatric psychia- trists have extra training in dealing with problems in the elderly. Certification in these specialties is available from the American Board of Psychiatry and Neurology. Psychiatric training programs focus more on drug treat- ment than on psychologic therapies. Psychologists have undergone training in the study of human behavior. Students of psychology study the mental, emotional, biologic, and social basis for human behavior, as well as theories that account for individual differences and abnormal behavior. They are also in- structed in research methodology, statistics, psychologic testing, and a variety of skills applicable to their spe- cialty if they intend to practice. The major recognized specialties are counseling, clinical psychology, school psychology, and industrial-organizational psychology.
• Professional help is appropriate when an emotional problem significantly interferes with someone’s ability to func- tion or when symptoms exceed an individual’s tolerance.
• Selecting a suitable therapist should be done with great care.
• Personality testing is unlikely to be a cost-effective component of a treatment process.
• Very few “self-help” products claimed to improve mental functioning have been scientifically tested; it is safe to assume that the vast majority do not work.
• Individuals undergoing psychotherapy should be alert for boundary violations or other signs of mismanagement.
keep theSe pointS in Mind aS You StudY thiS chapter
Key Concepts
Chapter Six Mental and Behavioral Help 91
Psychologists commonly work in private individual or group practices, community mental health centers, mental hospitals, general hospitals, schools, rehabilita- tion centers, and residential facilities for emotionally disturbed children. Payment for treatment by a psycholo- gist is deductible as a medical expense for federal income tax purposes and is covered by many insurance plans. In most states, licensing or certification for indepen- dent practice as a psychologist requires: (a) a doctoral degree (Ph.D. or Psy.D.) from an accredited training program, (b) additional years of supervised clinical expe- rience, and (c) passage of an examination. The National Register for Health Services Providers in Psychology, published by the Council for the National Register, lists licensed psychologists whose doctoral degrees and supervised experience meet the Register’s standards. A few states allow persons with master’s level training to work as associates or assistants under the supervision of licensed or certified professionals. In many states, psychologic associations are seeking passage of laws that would enable psychologists who undergo additional training to prescribe psychotropic medications.4 Those who do so typically refer to them- selves as medical psychologists. Psychiatric organiza- tions and some psychologists oppose this on grounds that a full medical education is necessary to understand the intricacies of prescribing powerful drugs. New Mexico, Louisiana, and all branches of the U.S. uniformed services currently authorize medical psychologists to prescribe medications. Psychoanalysts are practitioners who have under- gone personal psychoanalysis and have completed sev- eral additional years of part-time training in the theories and specialized techniques of psychoanalysis. Most are psychiatrists or psychologists, but some are trained in social work or another nonmedical discipline. However, because the psychoanalyst designation is not regulated by law, anyone can use the title. Social workers practice in private offices as well as under the auspices of public, voluntary, and proprietary agencies and institutions. They are licensed or otherwise regulated in all states. The National Association of So- cial Workers (NASW) states that clinical social workers provide more than half of the counseling and therapy services in the United States. Certification in clinical social work or another specialty is available from the Academy of Certified Social Workers (ACSW). This requires (a) a master’s or doctoral degree from a school of social work accredited by the Council on Social Work Education, (b) 2 years or 3000 hours of postgraduate
experience under the supervision of a master’s level social worker, and (c) passage of a written examination. The NASW Register of Clinical Social Workers lists those who meet the requirements for Qualified Clinical Social Worker (QCSW) or Diplomate in Clinical Social Work (DCSW). Both of these require 2 years of supervised clinical work plus either licensure, certification based on an examination, or ACSW membership. The DCSW credential requires an additional 3 years of professional experience plus completion of a clinical assessment examination. NASW also offers certifications related to health care; school settings; substance abuse; case work; and work with children, youth, and families.5
Certified clinical mental health counselors work in agencies, schools, colleges, and independent practice. They must have a master’s or doctoral degree in coun- seling or a related discipline plus 2 years of clinical ex- perience after receiving the master’s degree. They must also pass a written examination and adhere to a code of ethics. All states license or register clinical mental health counselors, with the most common designations being Licensed Professional Counselor (LPC) and Licensed Clinical Professional Counselor (LCPC). The National Board for Certified Counselors offers the National Certified Counselor (NCC), National Certified School Counselor (NCSC), Certified Clinical Mental Health Counselor (CCMHC), and Master Addictions Counselor (MAC).6 Specialists in psychiatric nursing are registered nurses (R.N.s) who usually hold a master’s degree from a program that lasts 11/2 to 2 years, but the term “psychi- atric nurse” may also be applied to any nurse who has worked in a psychiatric setting. The American Nurses Association certifies psychiatric nurses on two levels. Certification as a psychiatric and mental health nurse requires a bachelor’s degree in nursing, 2 years (with a minimum of 1600 hours) of experience in a mental health setting, current clinical practice, and passage of an examination. Clinical specialist certification requires a master’s degree in psychiatric nursing (or equivalent training), 500 hours of supervised clinical experience, and passage of an examination. The Directory of Spe- cialists in Psychiatric Mental Health Nursing provides names of clinical specialists in psychiatric nursing. Some psychiatric nurses lead therapy groups or serve as co- therapists in mental hospitals and clinics. Master’s-level psychiatric nurses may function as psychotherapists in community mental health centers. Some have set up private practices, providing both individual and family therapy.
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Marriage and family therapists are licensed or cer- tified in nearly every state. Clinical membership in the American Association for Marriage and Family Therapy (AAMFT) requires appropriate master’s- or doctoral- level training plus 2 years of clinical graduate experience with couples and families under the supervision of an AAMFT-approved supervisor. Training programs in the United States and Canada are accredited by AAMFT’s Commission on Accreditation for Marriage and Family Therapy Education. Sex therapists specialize in the treatment of sexual problems that can be helped by simple techniques and increased communication between sexual partners. They may or may not be able to deal with underlying emo- tional problems that require additional psychotherapy. Certification is available from the American Association of Sexuality Educators, Counselors and Therapists (AA- SECT), an interdisciplinary interest group. Certification as a sex therapist requires: (a) a master’s or doctoral degree plus 2 to 3 years (1000 hours/year) of clinical experience, (b) licensure or certification in an appropri- ate professional discipline, (c) 90 hours of specialized education, (d) 90 hours of sex-therapist training, (e) 500 hours of supervised therapy, and (f) 150 hours of
supervision by an AASECT-certified supervisor. A few graduate programs that incorporate sex-therapy training provide an alternative route to eligibility. Certification as a sex counselor has similar requirements but can be obtained with a bachelor’s degree. AASECT publishes a register of those it has certified. Because sex therapy is neither defined nor regulated by law, anyone can adopt the title of “sex therapist” or “sex counselor.” For this reason it is important to check the credentials and reputation of a prospective therapist. Those practicing at university-affiliated clinics can be presumed competent. Information about other therapists may be obtained from your family physician, the local medical society, or a local family service agency. Substance abuse counselors offer evaluation, coun- seling, case management, and various other services to individuals who abuse alcohol or other drugs. Some counselors have entered the field without a college education. However, associate-, bachelor-, or master- degree programs are required for many jobs. To become a National Certified Addiction Counselor (NCAC), can- didates must hold current state certification or licensure as an alcoholism and/or drug abuse counselor, have 6000 hours or 3 years of full-time supervised experience, and pass a written examination administered by the As- sociation for Addiction Professionals (NAADAC). The credentials required for substance abuse counselors vary from state to state. There are many other types of mental health prac- titioners whose activities are not defined by law or regulated by licensure. Included in this category are caseworkers, social-work aides, clergy, art therapists, music therapists, dance therapists, school counselors, crisis-intervention personnel, and a wide variety of self- proclaimed therapists. Some have appropriate training, but others do not. Compatibility between patient and therapist is more important in psychologic treatment than it is in the treatment of physical problems. There are several reasons why finding a suitable therapist for a mental or emotional problem may be more difficult than finding one for a physical problem or for general medical care:
1. There is a wide range of types of practitioners. 2. Some types of practitioners lack standardization of training
and credentials. 3. Many different approaches may be used by practitioners
within each professional group. 4. The person seeking help may have no idea which type of
treatment approach is most appropriate. 5. Many practitioners use questionable practices, some of
which may be difficult to recognize.
The Well-Credentialed Cat A Philadelphia psychologist obtained certificates for his cat from five organizations: “certification” from the National Guild of Hypnotists and the International Medical & Dental Hypnotherapy Association; “regis- tration” from the American Board of Hypnotherapy; and “professional membership” in the American As- sociation of Professional Hypnotherapists. In each case, the only requirement was completion of a brief online questionnaire and payment of a fee—none checked any of the cat’s alleged credentials. The cat also obtained “board certification” from the American Psychotherapy Association (APA), an affiliate of the American College of Forensic Examiners. Although the APA asked for the cat’s curriculum vitae, it did not ask for documentation of credentials or check whether anything listed in the CV was genuine. Nor did it require any examination before issuing a certifi- cate attesting to the having met “rigid requirements” resulting in her “designation as a Diplomate.” The ac- ceptance letter that accompanied the certificate stated that diplomate status “is limited to a select group of professionals who, by virtue of their extensive training and expertise, have demonstrated their outstanding abilities in regard to their specialty.”7
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pSYchologic MethodS
Psychotherapy can be defined as any type of persuasive or conversational approach designed to help patients. Although there are hundreds of techniques and schools of thought, most have in common a wish to understand the patient and help the patient change emotional or behavioral patterns. Psychodynamic treatments are based on the premise that childhood experiences exert an unconscious influ- ence that actively shapes people’s current feelings and behavior. In analytically oriented psychotherapy, also called exploratory therapy, patients say what comes to mind (free association) and are helped to understand their feelings, mental mechanisms, and relationships with people. Insights are used to help patients develop healthier ways of dealing with feelings and life situ- ations. This type of therapy typically involves one or two 50-minute sessions per week for a few months (short-term therapy) or years (long-term therapy). It is especially appropriate for people who communicate well and are motivated to change. Psychoanalysis is a more intensive form of psychodynamic therapy in which free association is done while lying on a couch. It usually requires three to five sessions per week for several years. Few people can afford its high cost. Supportive therapy is a conversational approach in- tended to maintain or restore an individual’s highest level of functioning. Therapists give advice and reassurance, make suggestions, and discuss alternative behaviors and problem-solving techniques. Depending on the nature of the problem, treatment ranges from a single session, or a few sessions over a period of weeks or months, to long-term care over many years. Cognitive therapy, which typically involves 15 to 25 weekly sessions, is aimed at relieving symptoms rather than resolving underlying conflicts. It is used for the treatment of depression, anxiety disorders (mainly panic and phobias), anger management, personality disorders, and marital therapy. Therapeutic efforts center on decreasing faulty perceptions and negative attitudes. This is done by identifying how the patient reacts to life situations and helping the patient test the validity of these reactions. For example, someone who assumes that bad things never happen to good people might feel intensely unworthy in the face of an adverse event. The therapist attempts to modify this tendency by persuading the pa- tient that adverse events occur for many reasons, most of which have nothing to do with the person’s worth. Interpersonal therapy focuses on current relation- ships in order to help people deal with unrecognized
needs and feelings and improve their interpersonal and communication skills. It typically involves three or four months of weekly 1-hour sessions in which the patient and therapist discuss the patient’s current relationships with family, friends, co-workers, neighbors, and others. The therapy also uses the patient-therapist relationship to help understand how the patient behaves in everyday life and is perceived by others.8
Behavioral therapy (also called behavior modi- fication) aims to replace maladaptive patterns with healthier ways of behaving. The therapist first analyzes the behaviors that cause stress, limit satisfaction, and affect important areas of the patient’s life. Treatment techniques can include (a) systematic desensitization (mastery of fears through gradual imagined exposure to circumstances that provoke anxiety), (b) relaxation train- ing, (c) exposure (gradual exposure to feared objects or situations), (d) flooding (maintaining exposure to feared situations until the anxiety dissipates), (e) reinforcement (rewarding behavior that is more mature), (f) modeling (copying a behavior demonstrated by the therapist), (g) social skills training, and (h) paradoxical intention (tem- porary encouragement of behavior the patient wishes to stop). Behavioral therapy usually involves fewer than 25 sessions. Biofeedback is a relaxation technique that can help people learn to control various autonomic functions. The patient is connected to a machine that continuously signals the heart rate, degree of muscle contraction, or other indicator. The patient is instructed to relax so that the signals decrease to a desirable level. The patient may ultimately learn to control the body function sub- consciously without the machine. Biofeedback was popularized before it had scientific support, and it is still abused by fringe practitioners. Nev- ertheless, it has gained a measure of respectability.9 It has been used to help patients control pain, anxiety, phobias, hypertension, sleep disorders, and some stomach and intestinal problems. Specialized techniques have been used to treat abnormal heart rhythms, epilepsy, Tourette syndrome (multiple tics), fecal incontinence, and Parkin- son’s disease. Most people who go through biofeedback training use it to acquire relaxation skills that could also be learned without electronics. Most qualified practitio- ners are psychologists, but some have backgrounds in other health disciplines. Untrained individuals with or without a professional degree can easily obtain a bio- feedback device and set up shop. Some promoters allege that “repatterning” a person’s brain waves can foster ef- fortless learning, health, creativity, and prosperity; others claim to achieve similar effects by causing the left and
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right halves of the brain to function more synchronously. No scientific evidence supports such claims. In group therapy several people, usually eight to ten, meet with a therapist for discussion. Groups may be ho- mogeneous (composed of people with similar problems or backgrounds) or heterogeneous. The discussion may focus on specific topics or may deal with whatever comes up. Group discussions often help people feel less alone in their feelings and provide a “laboratory” for analysis of an individual’s behavior in a group situation. Reticent individuals may find group sessions, in which they can sit and listen, preferable to individual sessions in which they find it difficult to talk. In marriage counseling, husband and wife meet individually or together with a therapist to help them identify current marital conflicts. Acting as a referee, the therapist helps the couple communicate more effec- tively to negotiate solutions to their dispute. In family therapy the therapist meets with the family as a group
to help resolve current family conflicts. Sex therapy is most appropriate for couples who basically get along well but have a problem with sex. Couples whose gen- eral relationship is poor will probably be better off with marital counseling or individual psychotherapy. Hypnosis is a temporary condition of intense con- centration or relaxation during which suggestibility is greatly enhanced. This state may be used to increase the patient’s control over a symptom or behavior. Hyp- nosis is not a treatment in itself but may accelerate the treatment process in properly selected cases. It has also been used for anesthesia during childbirth and dental procedures and for relief of headaches and other pain- ful conditions. Because not everyone is amenable to hypnosis, the therapist should have adequate training in both the procedure and the selection of patients. Expressive or creative activities, such as art, music, drama, poetry, or dance, are included in comprehensive treatment programs at hospitals and partial-hospital facilities.
drug therapY
Drugs are commonly prescribed for the treatment of anxiety states, depression, psychosomatic disorders, and psychoses. These drugs can affect both mental and physical functioning. Some take effect at once, some take several days to work, and some continue to work long after their use is discontinued. Antianxiety agents (sometimes referred to as minor tranquilizers) are used to treat anxiety states, psycho- somatic disorders, and alcohol addiction (during the detoxification process). Antipsychotic agents (sometimes referred to as major tranquilizers) are used mainly to treat psychotic reactions (thought disorders manifested by hallucina- tions, delusions, or loss of contact with reality). Since the early 1950s these drugs have revolutionized the field of psychiatry. Many patients who otherwise would have required lengthy (even lifelong) hospital stays are now able to improve or recover quickly. In addition, many previously institutionalized patients have been able to return to their communities. This has been a mixed bless- ing, however, because it has increased the number of homeless individuals in communities that lack adequate programs for helping the chronically mentally ill. Antidepressants are available to counteract severe depressions (those manifested by loss of appetite, weight loss, severe insomnia, feelings of hopelessness, or psy- chomotor retardation or agitation). These drugs usually require from a few days to several weeks to take effect.
“Animal Magnetism” The concept of a dreamlike or hypnotic state dur- ing which cures of symptoms are attempted has existed since ancient times. During the eighteenth century a version was popularized by Austrian-born Franz Anton Mesmer (1733–1815), who acquired three doctoral degrees, including one in medicine. Mesmer derived his concept of “animal magnetism” from astrology and asserted that an invisible fluid permeated the universe, that blockages within the body could make people ill, and that removing the blockages would be curative. Although his theory was unfounded, his strong personality and suggestive approach helped some patients who had hysterical or psychosomatic symptoms. Mesmer treated individuals by touching them in various ways while staring into their eyes. He also treated groups who sat around a large vessel while he walked around to direct the flow of his alleged fluid. Most of his colleagues thought he was a charlatan. In 1784 the French government appointed a commission of experts (including Benjamin Franklin) to investi- gate. After conducting a brilliant series of controlled experiments, the commission attributed his cures to suggestibility, which they described as “imagination set in action.”10 Mesmer’s popularity waned after the report was issued. Today hypnosis plays a modest role in the treatment of emotional problems, and the word “mesmerize” means to hypnotize, spellbind, fascinate, or enthrall.
Historical Perspective
Chapter Six Mental and Behavioral Help 95
They are not appropriate for countering the minor upsets that are part of ordinary living. Some antidepressants and antipsychotic drugs can be prescribed as a single bedtime dose. This method reduces the cost of the medication, may aid sleep, and reduces the likelihood of annoying side effects. Antimanic agents, most notably lithium products, are used for bipolar illness (sometimes called manic- depressive psychosis). Anti-obsessive-compulsive agents are used to treat patients with uncontrolled repetitive thoughts or actions. Antianxiety agents and several other types of drugs are commonly prescribed for insomnia. Although oc- casional use of a “sleeping pill” may be appropriate, habitual use is not. People with frequent insomnia should seek professional help to correct the cause or to develop better sleep habits. Americans have been accused (with some justifica- tion) of being a “drugged society” because of their high use of alcohol and medications such as Valium (an anti- anxiety agent) and Prozac (an antidepressant). Although most people who receive antipsychotic medications probably need them, it is clear that physicians often prescribe antianxiety agents or antidepressants when it would be more appropriate to help patients identify
and correct what is troubling them. Physicians are not entirely to blame for this, however; patients often press for instant and total relief. All psychoactive drugs have the potential for adverse reactions, some serious and some not. In each case the value to the patient must be weighed against the nuisance or danger involved. The most common side effects are drowsiness, agitation, dry mouth, tremor, and muscle stiffness. Some of these disappear with reduced dosage, continued use, or medication to counter them. Others are a reason to switch to another drug. One complication of particular concern is tardive dyskinesia, an involuntary movement disorder charac- terized by twitching and tongue-thrusting, which can occur with a prolonged high dosage of antipsychotic medications. Although uncommon, it is often irrevers- ible. Because the dangers of psychosis far outweigh the risk of tardive dyskinesia, there is no reason to withhold antipsychotic medication from individuals who are psy- chotic. However, it is poor medical practice to prescribe these drugs for nonpsychotic anxiety. The danger of withdrawal reactions to psychiatric drugs has been grossly exaggerated by the media. The problem sometimes develops with normally prescribed dosages of Valium and similar antianxiety drugs, but can be avoided by the common precaution of tapering off dosages rather than stopping suddenly.
electroconvulSive therapY
Electroconvulsive therapy (ECT), also referred to as EST (electroshock therapy) and shock treatment, involves producing a convulsion by giving a brief stimulus to the brain. To receive the treatment, the patient lies down and is rendered unconscious either by an electrical stimulus or by a short-acting barbiturate given intravenously. To protect against injury, a curare-like drug is also given so that the patient’s muscles do not contract during the convulsion. Electrodes are applied to one or both temples, and a small amount of current is transmitted to induce the convulsion. After the treatment the patient usually remains unconscious for about 15 to 30 minutes. A series of treatments may cause memory difficulty that clears up in a few weeks except for memories of some events during the months close to the period of treatment. However, the ability to remember other things or to retain new information is rarely impaired.12,13 ECT can be dramatically successful in certain types of severe depression and is sometimes helpful in severe psychotic reactions. However, it is seldom appropriate unless medication alone fails to produce results.
An Attack from Within An acute anxiety attack is of sudden onset and may even begin without any apparent precipitating event. The patient is suddenly extremely apprehensive. He is aware of palpitations. Perspiration becomes profuse and breathing is difficult. . . . The patient often fears that a medical calamity is taking place within his body. Particularly during the first such attack, the patient is apt to feel that he will faint, or die, or lose control of himself or of his mind. In the severe anxiety attack, the patient literally reaches a panic state where he feels overwhelmed and completely helpless. He is aware of a tremendously strong impulse to run away from wherever he is. He knows not from what he runs, nor even clearly where safety lies. Even following the attack, the patient remains chronically fearful lest he suffer another such unpleasant attack. This, of course, creates . . . additional anxiety which only tends to aid in the precipitation of further attacks. O. Spurgeon English, M.D. Stuart M. Finch, M.D.11
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pSYchoSoMatic diSorderS
From time to time everyone experiences symptoms that are physical reactions to tension. Common examples are headaches, diarrhea, constipation, nausea, dizziness, muscle cramps, dry mouth, cold hands, indigestion, excessive sweating, and palpitations of the heart (see Personal Glimpse box). Whether treatment is needed depends on the severity and frequency of the symptoms. They may require no treatment, self-medication with an over-the-counter product, medical care, or psychiatric treatment. These psychosomatic (psychophysiologic) reactions are mediated through the autonomic nervous system and are related to the action of adrenaline and related hor- mones on various parts of the body. Diarrhea before an examination, for example, is caused by increased intes- tinal motility. Tension headaches are caused by muscular tension in the back of the neck. Indigestion may result from excessive production of acid in the stomach. The symptoms of acute anxiety attacks—sweating, rapid heartbeat, palpitation, and a feeling of dread—are caused by release of adrenaline. Anxiety can also trig- ger hyperventilation syndrome, in which a feeling of shortness of breath is accompanied by lightheadedness and numbness of the hands and feet. On the more seri- ous side, asthma, high blood pressure, backache, and ulcerative colitis can have significant emotional com- ponents. Psychophysiologic reactions may be treated with (a) drugs that prevent the hormones from affecting the target organs, (b) antianxiety drugs or behavioral therapy to reduce tension, (c) psychotherapy to resolve the underlying causes of the tension, or (d) a combination of these. A large percentage of the ailments for which people seek medical attention are significantly related to tension. Excessive intake of caffeine is a common cause of symptoms that resemble those of chronic anxiety. The FDA requires food and drug labels to disclose the pres- ence of caffeine, but many people don’t realize that in addition to being present in coffee, caffeine is also found in tea, some soft drinks, and certain pain-relievers and cold remedies. Caffeine’s effect can last up to 18 hours in sensitive individuals. In people who become physically dependent on it, withdrawal during the night can cause headaches and grogginess in the morning.
inpatient care
Psychiatric inpatient care is needed in four basic situ- ations: (1) the patient is considered dangerous to self
(either suicidal or not eating enough to sustain life), (2) the patient is considered dangerous to others, (3) the patient is so malfunctional that community care is not possible, or (4) specialized treatment available only on an inpatient basis is needed. Many communities have day-care or “partial-hospi- talization” programs where patients spend 6 to 8 hours per day in a therapeutic atmosphere. Some hospitals have night-care programs. Halfway houses can ease the transition from hospital to community living. Patients who are judged sufficiently dangerous to themselves or others can be committed involuntarily to either inpatient or outpatient treatment. Contrary to popular opinion, court decisions and state laws tend to define “dangerousness” rather narrowly. As a result, commitment against a person’s will can be difficult to initiate or sustain. A type of advance directive may be used to provide seriously mentally ill people who are in remission with a way to consent to treatment if they become too sick or upset to do so. These documents describe when and how treatment should be implemented if the patient becomes incompetent to make a rational voluntary decision.
help for addictive Behavior
Addictions are habitual patterns of chronic, excessive, sensation-seeking activities that persist even though they cause adverse social, family, occupational, or health problems. Potentially addictive behaviors include not only the use of alcohol, tobacco, and some other drugs, but also activities such as gambling, eating, exercising, shopping, playing video games, and sex.14 Although some people may recover from or mature out of some addictive behaviors on their own or with social support, others require assistance from professionals, self-help groups, or self-help materials. Professional assistance includes individual and group counseling, medications, and cognitive-behavioral therapy focusing on relapse prevention. Chapter 17 discusses help with smoking cessation.
Drug Abuse Programs The treatment of drug abuse depends on the nature of the drug and the abuse pattern. Several types of treatment programs exist for people who use alcohol or other drugs excessively. Short-term methods include detoxification, residential therapy, medications to counteract or alter sensations produced by drugs, and drug-free outpatient therapy. Professional detoxification services enable people to withdraw safely and with reduced distress from
Chapter Six Mental and Behavioral Help 97
drugs such as alcohol and heroin. Longer-term treatment may include methadone maintenance and residential therapeutic community treatment. Most inpatient programs for people with alcohol and other drug programs emphasize the use of self-help fellowships such as Alcoholics Anonymous or Narcotics Anonymous. These programs promote teachings about alcoholism or chemical dependency as an inevitably progressive disease of body, mind, and spirit that cannot be cured, but for which a “recovery” process is possible. Such teachings are not well supported by scientific evidence.15
For substance abuse treatment of adults, the Cali- fornia Evidence-Based Clearinghouse for Child Welfare (CEBC) has rated motivational interviewing—a direc- tive method to increase client motivation to change—as “well-supported by research evidence” and has rated various programs to support coping skills and com- mitment to recovery—including the community rein- forcement with vouchers approach—as “supported by research evidence.” For substance abuse treatment of adolescents, CEBC has rated multidimensional family therapy and multisystemic therapy as “well-supported by research evidence” and has rated adolescent com- munity reinforcement approach and several additional family therapy approaches as “supported by research evidence.”16
Selecting a therapiSt
Four basic questions should be considered during the process of seeking mental health treatment: 1. What type of help is wanted? 2. Which practitioners can provide such help? 3. Are they available in the community? 4. How much can the patient afford to pay?
If medication is desired, one should see a physi- cian. Most nonpsychiatric physicians can competently prescribe antianxiety agents and antidepressants for pa- tients who are not severely disturbed. For antipsychotic drugs, a high dosage of antidepressants, or any type of long-range treatment, it is best to consult a psychiatrist. Certification by the American Board of Psychiatry and Neurology is a good indication that a psychiatrist is qualified to administer medication, but this certification is not as useful a guideline in selecting a psychotherapist. If a conversational treatment is preferred, names may be obtained from a personal physician, cleric, school counselor, friend, local medical or psychiatric society, local or state psychologic association, or the local Yellow Pages. Psychoanalytic institutes located
in some major cities and the departments of psychiatry at medical schools and hospitals can provide names of psychiatrists and psychologists who specialize in psy- chotherapy. Psychiatrists who have trained at university hospitals are more likely to be primarily interested in psychotherapy than those who have trained at state hos- pitals. However, psychotherapy has been relegated to a minor role in residency training programs, so the supply of psychiatrists who offer it has been dwindling. When seeking conversational treatment, “Do you primarily do psychotherapy?” is a good screening question. Many professional and certifying organizations publish a directory. Some public, hospital, and medical school libraries carry such directories, and many organi- zations have online referral mechanisms. Credentials can also be checked by contacting the national professional organizations listed in the Appendix. The current cost of psychotherapy with a private practitioner is usually $75 to $175 for a 50-minute ses- sion. Psychiatrists and psychologists tend to charge more than other therapists. In many communities, people who cannot afford private care can receive treatment at a mental health clinic where fees are based on the ability to pay. Most psychotherapy at community clinics is done by psychologists and social workers. A limited amount of counseling is available without charge to students through the student health service at most colleges and universities. Insurance coverage for psychotherapy is usually not generous. It typically covers 50% to 80% of the insurance company’s allowable cost per session, with a low dollar limit on total cost per year. Student assistance programs at some colleges and universities and employee assistance programs in some workplaces provide services to people dealing with per- sonal challenges including family or relationship issues, work-related problems, bereavement, addictions, stress, depression, or an array of other personal challenges. They provide services such as assessment, diagnosis, referral, crisis intervention, and brief treatment for free or at minimal cost. Psychiatrist Ronald Pies17 recommends consultation with a physician whenever mental problems are associ- ated with any of the following symptoms: blackouts; memory lapses (such as trouble recalling recent events); persistent headaches; significant unintentional weight loss; numbness; tingling or other strange sensations; generalized weakness; dizzy spells; significant pain of any sort; difficulty walking; shortness of breath; seizures of any type; inability to control urination; unduly rapid or forceful heartbeats; frequent, heavy sweating; tremor; or slurred speech.
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Consumer Reports magazine has published the results of three large surveys of its readers’ experiences with mental health professionals. The first survey18 drew 4100 responses from readers who had sought profes- sional help for emotional problems between 1991 and 1994. Almost all felt they had been helped, with those who initially felt the worst reporting the most progress. Significantly more improvement was reported with long- term therapy than with short-term therapy. Overall, the respondents felt that psychiatrists, psychologists, and social workers were equally effective, and that marriage counselors were less so. Those who relied on their fam- ily doctors were more likely to receive medication and be less satisfied than those who sought specialized care. Consumer Reports’ second survey,19 which yielded about 3100 responses, found:
• A combination of talk therapy and drugs often worked best. But “mostly talk” therapy was almost as effective if it lasted for 13 or more visits.
• “Mostly drug” therapy was also effective for many people. Drugs had a quicker impact on symptoms than talk therapy, but it often took trial and error to find a drug that worked without unacceptable side effects.
• Forty percent of people who took antidepressants com- plained of adverse sexual side effects.
• Care from primary care doctors was effective for people with mild problems, but less so for people with severe ones.
The third survey, which drew 1544 responses, found most people were helped, but those who used both drugs and talk therapy for at least seven visits fared best.20 These results mirror other research findings that most people who seek treatment benefit from it and, for most problems, the most important factor in psychotherapy is the patient-therapist match rather than the type of treatment.21,22
How much therapy is “enough” depends largely on the patient’s personality and the nature of the problem. Obvious symptoms tend to diminish fairly quickly, but personality change usually takes longer. How can progress of therapy be measured? One sign is lessening of symptoms such as anxiety or depression. Another is mastery or better management of stressful situations that previously had caused difficulty. However, symptom relief can be temporary, and other types of improvement may not be obvious until many months have elapsed. Hales and Hales23 state that although there are no consistent indications that therapy is on course, there are “red flags” that suggest when it is not. These include a sense that the therapist doesn’t understand the problem, difficulty communicating or confiding, dreading each session, feeling “stuck,” and feeling that the therapist is
behaving unethically. Negative feelings do not necessar- ily mean that the treatment is not working. People who feel they are not making progress should discuss their concern with the therapist. Ethical violations (some of which are discussed later in this chapter) are a reason to switch therapists.
QueStionaBle “Self-help” productS
Many recordings, books, and devices have been mar- keted with claims that they inspire people to function better mentally, improve relationships with others, re- lieve anxiety or depression, or achieve other desirable emotion-related goals. Gerald Rosen, Ph.D.,24 former chairman of the American Psychological Association’s Task Force on Self-Help Therapies, has noted:
• Although some of these materials may be helpful, most have not been tested for validity.
• Many self-help materials are promoted with extravagant and ethically questionable claims.
• The fact that a technique is useful as part of a therapy pro- gram does not mean it will work as a self-help measure. Self-help books are more likely to be helpful during periods of therapy than at other times.
• Few self-help books offer protection against failing to comply with instructions. Should failure occur, readers may inappropriately blame themselves, become skeptical that they can be helped, and fail to seek professional help.
Subliminal Recordings Thousands of videotapes, audiotapes, CDs, and DVDs purported to contain repeated messages are being mar- keted with claims that they can help people lose weight, stop smoking, enhance athletic performance, quit drink- ing, think creatively, raise IQ, make friends, reduce pain, improve vision, restore hearing, cure acne, conquer fears, read faster, speak effectively, handle criticism, relieve depression, enlarge breasts, and do many other things. At least one company has offered subliminal tapes for children, including a toilet-training tape for toddlers. Many products feature music said to promote relaxation. Most are claimed to contain messages that are inaudible or barely audible, but some are barely or fully audible. Videos may feature images, said to be relaxing, com- bined with repeated visual messages shown so briefly that they cannot be seen at normal playing speed. Many researchers have found that subliminal record- ings provide no benefit. One study of tapes from several companies concluded that they contained no embedded messages that could conceivably influence behavior.25
A research team tested tapes said to improve memory and self-esteem, but switched the tapes for half of the
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participants (to create a control group). Regardless of the tape used, about half of the subjects claimed to achieve the results they were told to expect—but objective tests of memory and self-esteem showed no change.26 A National Research Council committee concluded that although many people claimed that subliminal self-help tapes contribute to self-improvement, no scientific evi- dence supported such claims.27 Thus there is no reason to believe that music with subliminal messages can do anything more for physical or mental well-being than ordinary music. Recent research has shown that sub- liminal messages can be designed to alter what people think or want if they are unaware of receiving them, but this does not mean that such messages have therapeutic value.28
Biofeedback Gadgets Battery-operated skin-temperature monitors ($20 to $80) and devices that measure muscle or brain wave activity ($200 to $400) have been marketed through the mail for home use. The Harvard Health Letter has warned that such devices have not been systematically evaluated and are likely to “have a short working life before they wind up in a closet or attic, gathering dust.”9 Tests on home biofeedback devices claimed to help people manipulate their alpha waves have shown that the devices actually responded to the user’s eye movements or to interference from household electrical currents.
Self-Help Instructional Programs Many entrepreneurs are using cable television infomer- cials to promise that their instructional materials can increase self-confidence, improve people’s performance, and bring success in various ways. Forbes magazine has noted that “inspirational” programs may serve a useful purpose if they enable someone to act more decisively.29 However, the programs have not been validated by sci- entific studies and probably will not help most people who buy them.
“Brain Wave Synchronizers” Several companies have marketed gadgets that deliver flashing lights and sounds through modified eyeglasses and headphones. The devices are hazardous because flashing lights can trigger epileptic seizures in suscep- tible individuals, including some with no history of seizures. In 1992 the FDA was informed that a device of this type (the Relaxman Synchroenergizer) had caused a 21-year-old woman to have her first seizure. The device had been marketed with unsubstantiated claims that it could improve digestion and sexual function and con- trol pain, habits, and addictions. In 1993, at the FDA’s
request, government agents seized the manufacturer’s entire supply, which a judge subsequently ordered destroyed.30 The FDA also stopped the marketing of InnerQuest Brain Wave Synchronizer, which had been claimed to provide diet control, stress relief, pain relief, and increased mental capacity.31 In 1995 the FTC and four state attorneys general settled complaints against Zygon International, Inc., which had claimed that users of The Learning Machine would learn foreign languages overnight, quadruple their reading speed, expand their psychic powers, build self-esteem, and replace bad habits with good ones.32 The device cost about $300. Beyerstein33 has debunked claims that various devices help people by synchronizing the two sides of the brain or increasing the frequency of alpha waves (a type of brain wave). Currently marketed devices are said to provide “brain wave entrainment.”
Bach Remedies Bach remedies are made by soaking or boiling flowers in water to “transmit their energy” and diluting the re- sultant solutions with brandy. The products include an “emergency rescue formula” for “calming and stabiliz- ing emotions” and a line of 38 “flower remedies” said to alleviate negative emotions. In the United States, their leading marketer has been Ellon USA, Inc., of Lynbrook, New York. The products were developed during the 1930s by Edward Bach, a British bacteriolo- gist and homeopath, who—according to the company’s literature—“believed that the only way to cure illness was to address the underlying emotional causes of disease.” The flower remedies can be selected using Ellon’s 116-item “self-help questionnaire.” Someone who feels overwhelmed with work, for example, is advised to take Elm, whereas someone who has strong opinions and is easily incensed by injustices is advised to use Vervain. Another company describes its Rescue Remedy as “the one product you need to take care of all kinds of emergency emotional stress.” Its catalog has depicted the product as useful for (a) a woman under stress because her computer “froze,” (b) a mother cop- ing with a cranky toddler, (c) the partner of a doubles tennis player who missed a few shots, (d) participants in a minor auto accident, and (e) a man racing to board a plane who suddenly realizes he forgot to pack his suit and left his keys and ticket at home.
Dietary Supplements and Herbs Many products marketed as “dietary supplements” are claimed to improve mental functioning. Kava and valerian are said to relieve anxiety; St. John’s wort and S-adenosyl-methionine (SAMe) are marketed for the
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relief of depression; ginkgo biloba is claimed to improve memory; and many vitamin concoctions are recom- mended for treating Down syndrome, hyperactivity, autism, and other childhood conditions. Unlike prescription drugs, which require FDA ap- proval before they can be marketed, dietary supplements and herbs are not required by law to undergo rigorous testing for safety and effectiveness. Moreover, for those that show promise, there has not been enough research to determine whether they are safe or are as effective as FDA-approved drugs. In some cases, serious adverse effects have been documented. (For example, St. John’s wort interferes with the effectiveness of several prescrip- tion drugs, and kava, which the FDA has banned, can cause fatal liver disease.) In many cases, there is no credible evidence of benefit whatsoever. In addition, most herbal products sold in the United States are not standardized, which means that determining the exact amounts of their ingredients can be difficult or impos- sible. This subject is covered further in Chapter 11.
QueStionaBle practiceS
Many types of practitioners who profess to treat mental, emotional, and personal problems or to give advice are not qualified to do so. Because terms such as therapist, psychotherapist, and counselor are not defined by law, anyone may use these titles. The fields of sensitivity training, sexual counseling, marriage counseling, life coaching, hypnosis, and encounter groups contain many self-proclaimed therapists who have little or no training. Other types of unqualified practitioners ply their trade under titles such as astrolotherapist, autohypnotist, palm- ist, past-life therapist, reader-adviser, transformational counselor, metaphysician, graphologist (handwriting analyst), and character analyst. Some have certificates from diploma mills or correspondence courses. Some practitioners with reputable training and cre- dentials use methods that are unscientific or unethical. Some have personal problems that interfere with proper care of their patients, and some deliberately exploit their patients. The trouble with improper mental health treatment is not merely lack of efficacy. A disillusioning experience can cause the patient to stop seeking help or can trigger a personal disaster such as suicide.
Sensitivity Training/“Self-Growth” Groups Sensitivity training began in the 1950s with training groups (T-groups) whose purpose was to help communi- ty leaders ease social tensions in their communities. This was accomplished by an intense small-group experience that encouraged self-disclosure and expression of strong
feelings while focusing on the attitudes and interactions of group members. The process was not intended for the treatment of emotionally disturbed individuals. Over the years similar groups have proliferated under such names as marathon groups, growth centers, encounter groups, human-relations laboratories, human potential training, and large-group awareness training programs.34 Their stated purpose is to help people expe- rience personal growth by learning to express feelings more openly. They may have supportive or aggressive confrontations. Some groups emphasize physical com- fort or contact, such as touching. Meetings of this type can be very upsetting to people who are not self-confi- dent enough to handle the confrontation and emotional expression that can take place. Depression, psychosis, personality disorganization, severe anxiety reactions, and physical injuries have resulted from improperly conducted meetings. Consumers should generally be wary of groups whose participants are encouraged to express strong feelings to virtual strangers.
Meditation Meditation is generally defined as a class of techniques intended to influence an individual’s consciousness or tension level through the regulation of attention. It may involve lying quietly or sitting in a particular position, at- tending to one’s breathing (as in yogic practice), adopting a passive attitude, attempting to be at ease, or repeating a word aloud or to oneself (transcendental meditation). A National Research Council committee has con- cluded that people who meditate regularly may have a more restful lifestyle and that relaxation techniques might be appropriate for stress-reduction or as a com- ponent of other treatments. (Breathing exercises, for example, may be useful in behavioral approaches to treating panic attacks.) However, the committee found no scientific evidence that stress is reduced more effec- tively by meditation than by simple quiet resting or that meditation alone provides lasting benefits, such as reduc- ing high blood pressure or other unhealthy responses to stress.27 Megavitamin Therapy During the early 1950s a few psychiatrists began adding massive doses of nutrients to the treatment of severe mental problems. The original substance used was vitamin B3 (nicotinic acid or nicotinamide), and the therapy was termed “megavitamin therapy.” Since that time the treatment regimen has been expanded to include other vitamins, minerals, hormones, and diets, any of which may be combined with conventional drug therapy or ECT.
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Today the treatment is called “orthomolecular psy- chiatry,” a term meaning “the treatment of mental disease by providing an optimum molecular environment for the mind, especially substances normally present in the human body.” Proponents claim that abnormal behavior is caused by molecular imbalances that are correctable by administration of the “right” nutrient molecules at the right time. (Ortho is Greek for “right.”) They also claim that their treatment is effective against many diseases. During the 1980s, for example, the Princeton Brain Bio Center (not affiliated with Princeton University), in Skill- man, New Jersey, touted its “nutritional” treatment for alcoholism, allergies, arthritis, autism, epilepsy, hyper- tension, hypoglycemia, migraine headaches, depression, learning disabilities, retardation, mental and metabolic disorders, skin problems, and hyperactivity.35 Its services included laboratory tests that most physicians would not consider necessary or useful for diagnosing these disorders. A special American Psychiatric Association task force investigated the claims of the megavitamin and orthomolecular therapists. Its 1973 report36 noted that these psychiatrists used unconventional methods not only in treatment but in diagnosis. The report’s conclu- sion, perhaps the most strongly worded statement ever published by a scientific review body, stated:
This review and critique has carefully examined the literature produced by megavitamin proponents and by those who have attempted to replicate their basic and clinical work. It con- cludes in this regard that the credibility of the megavitamin proponents is low. Their credibility is further diminished by a consistent refusal over the past decade to perform controlled experiments and to report their new results in a scientifically acceptable fashion. Under these circumstances this Task Force considers the massive publicity which they promulgate via radio, the lay press and popular books, using catch phrases which are really misnomers like “megavitamin therapy” and “orthomolecular treatment,” to be deplorable.
The Research Advisory Committee of the National Institute of Mental Health reviewed pertinent scientific data through 1979 and agreed that megavitamin therapy was ineffective and could be harmful. After the U.S. Defense Subcommittee looked into this therapy, it was removed as a treatment covered by CHAMPUS, the insurance program for military dependents. Claims that nutrient megadoses are effective against psychosis, learning disorders, and mental retardation in children have been debunked by the American Acad- emy of Pediatrics (AAP) and the Canadian Paediatric Society.37 Both have warned that there is no proven
benefit in any of these conditions and that megadoses can have serious toxic effects. In 1976, the AAP concluded that a “cult” had developed among followers of mega- vitamin therapy.38 That description is still appropriate.
The Feingold Diet In 1973 Dr. Benjamin Feingold, a pediatric allergist from California, proposed that salicylates, artificial colors, and artificial flavors caused hyperactivity in children. Hyper- activity is now medically classified as ADD or ADHD. To treat or prevent this condition, Feingold suggested a diet that was free of such chemicals. His followers now claim that asthma, bedwetting, ear infections, seizures, sleep disorders, stomach aches, and a long list of other symptoms may respond to the Feingold program and that sensitivity to synthetic additives and/or salicylates may be a factor in antisocial traits, compulsive aggression, self-mutilation, difficulty in reasoning, stuttering, and exceptional clumsiness.39 Adherence to the Feingold diet requires a drastic change in family lifestyle and eating patterns. Home- made foods prepared “from scratch” are necessary for many meals. In addition, many nonfood items such as mouthwash, toothpaste, cough drops, perfume, and some over-the-counter and prescription drugs are prohibited. Feingold strongly recommended that the hyperactive child help prepare the special foods and encouraged the entire family to participate in the dietary program. The Feingold Cookbook states:
A successful response to the diet depends on 100 percent compliance. The slightest infraction can lead to failure: a single bite or drink can cause an undesirable response that may persist for seventy-two hours or more.
Many parents who have followed Feingold’s rec- ommendations have reported improvement in their children’s behavior. But carefully designed experiments have shown that the percentage of children who may become hyperactive in response to food additives is at best very small, and that improvement, if any, appears related to changes in family dynamics, such as paying more attention to the children.40,41 Experts have also noted that the foods recommended in Feingold’s book Why Your Child Is Hyperactive (1975) included some that were high in salicylates and excluded others that were low in salicylates. Because the Feingold diet does no physical harm, it might appear helpful in some cases. The potential benefits, however, must be weighed against the harmful effect of teaching children to blame food ingredients for their difficulties when other factors are responsible.
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sessions”—typically two half-hour sessions per day over a 10-day period—that involve listening to music that has been computer-modified to remove frequencies to which they supposedly are hypersensitive. The American Academy of Pediatrics and the American Academy of Audiology have warned that no well-designed scientific studies demonstrate that AIT is useful.44,45 AIT devices do not have FDA approval for treating autism, ADD, or any other medical problem. In 1997, the FDA banned the importation of the Electric Ear or any other AIT device made by Tomatis International, of Paris, France. Chelation therapy. Some chelation therapists are advising parents of autistic children that the cause is mercury poisoning. After administering an improper test, these practitioners state that the child’s mercury level is high and that “detoxification” with chelation therapy is needed.46 There is no scientific evidence that autism is caused by mercury poisoning or that chelation therapy will benefit autistic children. Chelation therapy is a cornerstone of what is com- monly promoted as “biomedical treatment.” Other components include dietary supplements, diets, and hormones (secretin and Lupron). Proponents claim that biomedical methods treat the “root causes” of learning/ behavioral problems rather than their symptoms. None of its components has been scientifically validated. A Cochrane review of 14 studies found no evidence that secretin is effective against autism and recommended against doing further research.47 Lupron, which blocks the action of the male hormone testosterone, can delay the onset of puberty and interfere with bone develop- ment.48 Chelation therapy is discussed in Chapter 8. Doman-Delacato treatment, also known as “pattern- ing,” was developed during the mid-1950s and offered at the Institutes for Human Potential in Philadelphia, Pennsylvania. Its proponents claim that the great major- ity of cases of mental retardation, learning problems, and behavior disorders are caused by brain damage or “poor neurological organization.” The treatment is based on the idea that high levels of motor and sensory stimulation can train the nervous system and lessen or overcome handicaps caused by brain damage. Parents following the program may be advised to exercise the child’s limbs repeatedly and use other measures said to increase blood flow to the brain and decrease brain irritability. In 1982 the American Academy of Pediatrics issued a position paper concluding that “patterning” has no special merit, that its proponents’ claims are unproven, and that the demands on families are so great that in some cases there may be actual harm in its use.49
There is additional potential for harm in creating situ- ations where a child’s eating behavior is regarded as peculiar by other children. The main group that promotes Feingold’s ideas is the Feingold Association of the United States (FAUS). Its newsletter has reported claims that schoolchildren and their teachers experienced ill effects from chemicals used in construction, furnishing, maintenance, pest control, and classroom activities at their schools. It was stated, for example, that one child was disciplined for reacting to his teacher’s perfume, another became abusive to- ward his mother because of the school’s newly painted lunchroom, and another required tutoring because of a reaction to a leak in the school’s oil furnace. Allega- tions like these are similar to the unsubstantiated claims made by clinical ecologists (see Chapter 8). Figure 6-1 illustrates a bumper sticker used to call attention to the FAUS’s views on food additives. Consumption of sugar and aspartame (an artificial sweetener) have also been blamed for hyperactivity, but well-designed studies have found no evidence supporting such claims.42,43
Questionable Treatments for Learning Disabilities and/or Autism Several approaches to learning disabilities, mental re- tardation, and autism have been identified as unproven and controversial. The Association for Science in Autism Treatment (www.asatonline.org) maintains summaries of the research relevant to autism interventions. Auditory Integration Training (AIT) was developed as a treatment for autism by Guy Berard in France in the 1960s and was introduced into the United States in 1991. It has also been advocated for children and adults with learning disabilities, ADD, depression, migraine headaches, and many other conditions. Proponents claim that individuals with these disorders often have hearing that is disorganized, hypersensitive, different between the two ears, or otherwise abnormal. The first step in AIT is an audiogram that determines the auditory thresholds to more frequencies than are typically measured during hearing tests. Suitable individuals then undergo “training
Figure 6-1. Feingold Association bumper sticker
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Eye movement desensitization and reprocessing (EMDR) is promoted for the treatment of post-traumatic stress, phobias, learning disorders, and many other men- tal and emotional problems. The method involves asking the client to recall the traumatic event as vividly as pos- sible and rate certain feelings before and after visually tracking the therapist’s finger as it is moved back and forth in front of the client’s eyes. EMDR resembles vari- ous traditional behavioral therapies for reducing fears in that it requires clients to imagine traumatic events in a gradual fashion in the presence of a supportive therapist. However, controlled research has shown that EMDR’s most distinctive feature (visual tracking) is unneces- sary and is irrelevant to whatever benefits the patient may receive and that the theory of EMDR clashes with scientific knowledge of the role of eye movements.50,51
Facilitated communication is a process in which a “facilitator” supports the hand or arm of a severely handicapped person who spells out a message using a computer keyboard, or other device containing a list of letters, numbers, or words. It is alleged to help indi- viduals strike the keys they desire without influencing the choice of keys. Some speech therapists and other special-education providers are using this procedure for nonverbal individuals with autism or severe mental retar- dation. Proponents claim that it enables such individuals to communicate. However, many scientific studies have demonstrated that the procedure is not valid because the outcome is actually determined by the “facilitator.”52 In one study, for example, autistic patients and facilitators were shown pictures of familiar objects and asked to identify them under three types of conditions: (1) as- sisted typing with facilitators unaware of the content of the stimulus picture, (2) unassisted typing, and (3) a condition in which the participants and facilitators were each shown pictures at the same time. No patient gave a correct response when the facilitator had not been shown the picture. The researchers concluded that the facilitators were not aware that they were influencing the patients.53 The American Psychological Association54 has denounced facilitated communication and warned that using it to elicit accusations of abuse by family members or other caregivers threatens the civil rights of both the impaired individual and those accused. In 1994 the FTC settled charges that two companies had made false and unsubstantiated claims about “facilitated communica- tion” devices they had marketed. Neural Organization Technique (NOT) is based on the notion that learning disorders, childhood psycho- ses, mental retardation, cerebral palsy, bedwetting, and colorblindness are related to muscle imbalances caused
by misaligned skull bones. NOT, a variation of cranial therapy (described in Chapter 8), was developed by New York chiropractor Carl Ferreri and has been taught to hundreds of other chiropractors. Its proponents claim to correct “blocked neural pathways” by “adjusting” the bones of the skull with pressure to various parts of the head. NOT came to public attention when chiropractors subjected children to it in a “research” project spon- sored by school officials in California. A 1988 report in Hippocrates magazine described how children with epilepsy, Down syndrome, cerebral palsy, dyslexia, and various other learning disorders were forced to endure painful pressure against their skull, roof of the mouth, and eyes. One parent complained that pressure against her son’s eye sockets had caused a seizure.55 In 1991 a jury ordered Ferreri to pay $565,000 in damages to seven children and their parents who had filed suit for physical and emotional pain related to the treatment. Two other chiropractors involved in the case settled out of court for a total of $207,000. Neuro Emotional Technique (NET) is another chiropractic approach focused on “releasing patients’ emotional blocks stored in the body’s memory.” Its de- veloper, Scott Walker, D.C., of Encinitas, California, de- scribes NET as “a body-mind way, a non talk-it-out way, of dealing with emotional aberrations.” Its proponents
“Pop Psychology” Myths Much of what we believe about psychology isn’t true. Although scores of popular psychology sources are readily available . . . they’re rife with myths and misconceptions. For example:
• Hypnosis is useful for retrieving memories of forgotten events.
• Lie detector tests can accurately detect dishonesty. • Handwriting reveals our personality traits. • Extrasensory perception is a well-established
scientific phenomenon. • Playing Mozart’s music to infants boosts their
intelligence. • A positive attitude can stave off cancer. • It’s generally better to express anger to others than
to hold it in. • Only deeply depressed people commit suicide.
Scott O. Lilienfeld, Ph.D.56
Steven Jay Lynn, Ph.D. John Ruscio, Ph.D. Barry L. Beyerstein, Ph.D.
Personal Glimpse
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claim that everyone has such blocks and that the body “replays” these old memories, which can adversely af- fect health. The practitioner uses muscle testing (applied kinesiology) to “isolate a troublesome event,” asks the patient to hold in mind a “snapshot” of the emotional state while the chiropractor adjusts the patient’s spine and acupuncture points, and prescribes supplement products and homeopathic remedies. Optometric visual training is based on the idea that learning can be improved by exercises that improve coordination of the eye muscles or improve hand-eye co- ordination. Its proponents assume that the basic problem that leads to reading disability is some deficit in the visual system. The American Academy of Pediatrics57 and the American Academy of Ophthalmology have criticized this approach and cautioned that no eye-muscle defects can produce the learning disabilities associated with dyslexia. (Dyslexia is a reading disorder characterized by omissions, faulty word substitutions, and impaired comprehension. It is not due to mental retardation, lack of schooling, or brain damage.)
Neurolinguistic Programming Neurolinguistic programming (NLP) is purported to enable people to communicate more effectively and influence others. It is said to modify the patterns or “programming” created by interactions among the brain (neuro), language (linguistic), and the body that produce both effective and ineffective behavior. Proponents claim to have cured phobias, allergies, and other problems in one or a few brief sessions. NLP’s core postulates are: (a) people are most influenced by messages that reflect how they internally represent whatever they are doing and (b) this representation is reflected by eye-gaze pat- terns, posture, tone of voice, and language patterns. The internal representation can be visual (picturing what they are involved with), auditory (hearing it sounded out), or can involve other senses. Proponents claim, for example, that someone experiencing a mental image might use the words “I see,” whereas someone in an auditory mode might say “that sounds right to me.” Scientific studies have demonstrated no correlation between eye move- ments and visual imagery, reported thoughts, or language choices. A National Research Council committee58 has found no significant evidence that NLP’s theories are sound or that its practices are effective.
Attachment Therapy Attachment therapy involves a series of procedures intended to treat children, most of whom have been adopted or subjected to childhood abuse or neglect. The
procedures include (a) “rebirthing” in which the child is heavily restrained with blankets and pillows as adults push to simulate uterine contractions and the child is instructed to escape from the restraint to be “reborn”; (b) “holding therapy,” which involves restraint that is less severe, but sufficient to frighten and enrage the child; and (c) “therapeutic parenting” techniques that include physical and psychological seclusion of the child through various coercive means applied either by parents or by specially trained foster parents. The practice came to na- tional attention following the death of a 10-year-old who was suffocated by the weight of several adults who lay on top of her during a rebirthing session. Two of the adults were convicted of reckless child abuse and sentenced to prison.59 Subsequently, two states enacted laws against coercive “holding therapy” and the American Psychiatric Association issued a position statement opposing the use of coercive holding techniques for treating children with “reactive attachment disorder (RAD).”60
Past-Life Therapy “Past-life therapy” is based on the notion that psychologic disorders arise from the influence of traumas and per- sonality traits from previous lives that intrude on the subconscious. Proponents use hypnosis, meditation, or guided imagery to “regress” the patient to alleged earlier incarnations (“past lives”) that, when recalled, lead to resolution of the patient’s problems. There is, however, no scientific evidence that this theory is valid. Experiments have shown that “past-life” reports during hypnotic trances are related to the subject’s sug- gestibility and proneness to fantasize. In one study, 35 of 110 subjects who were asked to regress to times before their birth enacted “past lives.” In most of these cases, their past-life personalities were the same age and race as themselves. In another experiment, researchers informed half of the subjects that previous incarnations were often a different sex or race and had lived in exotic cultures. Those who received this advice were significantly more likely to incorporate one or more of the suggested characteristics into their past-life descriptions. Other re- searchers have found that subjects who gave information specific enough to be checked were much more often incorrect than correct. Based on these and similar find- ings, Spanos61 and Baker62 have concluded that past-life reports obtained from hypnotically regressed subjects are fantasy constructions of imaginative persons absorbed in make-believe situations and responding to regression suggestions—and that those who believe in reincarna- tion are the most likely to believe that such fantasies are related to an actual past life.
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Stimulation of False Memories If sexual abuse during childhood is a factor in a person’s distress, it is unlikely to be forgotten. However, patients who are suggestible or eager to please their therapist may “remember” childhood events that did not actu- ally take place. Usually it is the therapist who suggests this possibility, either deliberately or unwittingly. Oc- casionally, however, the patient (possibly inspired by a book or television talk show) initiates the problem and the therapist fails to help sort fact from fantasy. Critics are using the term “false memory syndrome” (FMS) to describe the mental state generated in these situations. Some therapists encourage their patients to confront and possibly sue the alleged perpetrator. The False Memory Syndrome (FMS) Foundation was formed in 1992 to deal with the problem of adults who mistakenly believe that they were victims of incest or child abuse. The Foundation has been contacted by thousands of dis- tressed families for advice on how to cope with sudden attacks by angry children who accused them of misdeeds that may not have taken place.
Thought Field Therapy The founder of thought field therapy (TFT), psychologist Roger J. Callahan, Ph.D., claims that TFT “provides a code to nature’s healing system. . . addresses . . . funda- mental causes, balancing the body’s energy system and allowing you to eliminate most negative emotions within minutes and promote the body’s own healing ability.” The Callahan Techniques Web site also recommends dietary supplementation for persons who “suffer from multiple environmental sensitivities and even allergies which aggravate psychological problems.” During TFT sessions, the therapist uses sequences of finger taps on “acupressure points” (primarily of the hands, face, and upper body) and the patient does repetitive activities (repeats statements, counts, rolls the eyes, hums a tune) while visualizing a distressing situation. TFT is claimed to be nearly 100% effective against depression, phobias, and other psychologic problems. It is based on the notion that acupressure points are related to blockages (“perturbations”) of “body energy” associated with physical or emotional illness. Proponents claim that the finger-tapping releases the blockages and increases the body’s energy flow. TFT’s advanced techniques include muscle testing (a variation of ap- plied kinesiology) and “voice technology,” in which the practitioner analyzes the patient’s voice over the phone and determines where the patient should tap. “Voice technology” training for practitioners costs $100,000. Critics have noted that TFT’s underlying theories
clash with established scientific knowledge and that studies alleging benefit have been poorly designed.63
In 1999, the American Psychological Association’s Continuing Education Committee notified continuing education providers that TFT courses will no longer be approved for continuing education credits. Emotional Freedom Technique (EFT), developed by a Callahan disciple named Gary Craig, is said to be a simpler version of TFT that works more quickly. However, it is no more evidence-based than TFT.
Dianetics and “Purification” Dianetics, a method promoted by the Church of Scientol- ogy, is described by its proponents as “an exact pastoral counseling technology for the location and elimination of unwanted emotional conditions and physical prob- lems that are of spiritually induced origin.”64 In 2000, a Scientology web site listed 46 Dianetics Foundations in the United States and 221 in other countries. Dianetics was developed by L. Ron Hubbard (1911– 1986), a prolific science-fiction writer who founded the Church of Scientology. Hubbard’s Dianetics: The Modern Science of Mental Healing was originally pub- lished in 1950, has undergone several revisions, and is now called Dianetics: The Modern Science of Mental Health.65 It is widely advertised as “the owner’s manual for the human mind” and is said to have sold over 20 million copies. Individuals who return an inquiry card from the book may receive thousands of follow-up so- licitations for Scientology publications and seminars. According to Hubbard, the “analytical” (conscious) mind is a perfect recorder, computer, and solver of problems. It is incapable of error except when interfered with by “engrams,” recordings made by the “reactive” (unconscious) mind when the analytic mind is turned off by traumatic events. Hubbard’s book states that engrams stored in the reactive memory bank cause neuroses, psychoses, and psychosomatic disorders. The goal of Dianetics is to “clear” (erase) all engrams from the reactive bank. This is accomplished through a pro- cedure called “auditing,” in which the auditor may use an “E-Meter” to help the patient recall traumatic events and “drain them of their charge” so that they “no longer have power over the person.”66
Time magazine has described the E-Meter as “a simplified lie-detector . . . designed to measure electrical changes in the skin while subjects discussed intimate details of their past.”67 In 1963 the FDA seized more than 100 E-Meters at the headquarters of the Founding Church of Scientology in Washington, D.C. During the lengthy litigation that followed, a judge concluded68:
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Hubbard and his fellow Scientologists developed the notion of using an E-Meter to aid auditing. Substantial fees were charged for the meter and for auditing sessions using the meter. They repeatedly and explicitly represented that such auditing effectuated cures of many physical and mental illnesses. An individual processed with the aid of the E-Meter was said to reach the intended goal of “clear” and was led to believe that there was reliable scientific proof that once cleared, many, indeed, most illnesses would automatically be cured. Audit- ing was guaranteed to be successful. All this was and is false.
Upholding the FDA’s charges that the E-Meter was misbranded, the judge ordered that future use of the E- Meter be confined to “bona fide religious counseling” and that the device be prominently labeled with this warning notice69:
The E-Meter is not medically or scientifically useful for the diagnosis, treatment, or prevention of any disease. It is not medically or scientifically capable of improving the health or bodily functions of anyone.
The copyright page of Dianetics states that the E-Meter “is not intended or effective for the diagnosis, treatment or prevention of any disease, or for the im- provement of health or any bodily function.”65
HealthMed, a chain of clinics run by Scientologists, offers a “purification program” of saunas, exercise, high doses of niacin, and other vitamins and minerals. The program, designed by Hubbard, is said to rid the body of “chemicals and poisons” that can dull awareness, mental acuteness and emotions and “make a person feel dead, dull and lifeless.”70
In addition to espousing its own approaches, the Church of Scientology has actively criticized oth- ers. In 1969 it and Thomas Szasz, M.D., founded the Citizens Commission on Human Rights™ (CCHR) “to investigate and expose psychiatric violations of human rights.”71 In 2011, CCHR’s Web site reported that CCHR had “hundreds of chapters in 34 countries.” Its targets have included Prozac (the most widely prescribed antide- pressant drug), ECT, the use of Ritalin for hyperactivity in children, and “psychotherapist sex crimes.”72 A 1995 CCHR booklet urged readers to write to their legisla- tors to demand that psychiatric centers and programs be removed from their community.73 CCHR’s Web site states: “Psychiatry has no scientific basis for any of its treatments or methods.”74
Routine Personality Testing Psychologic tests allow the practitioner to sample a client’s behavior in standardized ways. There are three broad types: (1) “intelligence” tests, which tend to test achievement rather than intelligence per se; (2) aptitude
tests, which are used for vocational counseling and per- sonnel selection; and (3) personality tests, which assess emotional or social aspects of a person’s life. Objec- tive personality tests, like the Minnesota Multiphasic Personality Inventory (MMPI), ask directly about the client’s feelings and experiences. Personality tests, like the Rorschach inkblot test, elicit reactions to a series of ambiguous stimuli. Personality tests are intended to reveal aspects of a person’s view of self and others, along with interper- sonal and emotional tendencies. Some psychologists use them routinely as part of their evaluation or treat- ment methods. However, most psychiatrists and many psychologists believe that the information gained is not cost-effective in terms of time, effort, and fees. Critics charge that (a) personality tests are unlikely to reveal useful information that is not obtainable by talking with the patient, (b) projective personality tests may reflect the characteristics of the person who does the scoring rather than those of the person tested, (c) the testing process can convey an incorrect message that the therapist can extract information and provide treatment to a patient who does not participate actively in the treatment process, and (d) there is little research evidence that personality testing leads to more accurate diagnosis or better treatment out- comes. A scholarly review concluded that the Rorschach test, Thematic Apperception Test, Draw-a-Person Test (DAP), Bender-Gestalt Test, and Sentence Completion Test (SCT) are unlikely to contribute information that cannot be obtained from simpler tests or from other sources.75
Life Coaching Thousands of “life coaches” are offering to help others organize their life, make decisions, feel better about themselves, achieve their potential, become more cre- ative, adopt a healthier lifestyle, and generally inspire clients to deal better with the gamut of problems encoun- tered in daily life. Several organizations offer training and “certification” based on courses that take anywhere from a week to several years. The resultant credentials have no legal or academic recognition. Although it is possible for untrained individuals who are bright and empathetic to give good advice, consumers seeking mental help would be wise to consult professionals with recognized training and credentials.
Psychic Counseling Many entrepreneurs offer “psychic” advice by telephone. In the typical operation, callers dial a “900” number and are charged $2 to $4 per minute for the advice. In 1993 ABC-TV’s “Prime Time Live” aired the results
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of a 3-month investigation of a lucrative “psychic ho- tline.” One undercover investigator who had no prior knowledge of occult matters was hired by the hotline and underwent a few days of training in tarot cards, astrology, and numerology. She then used her intuition (plus code words written on tarot cards) to formulate her responses to callers. She reported being instructed to permit suicidal callers to run up their bill before referring them to a legitimate suicide hotline. Another undercover investigator, posing as a prospective inves- tor, interviewed a company director who said, “Most of the people’s personal lives—who work for us—are just total shambles. How they could even give the stuff out is incredible.” Lester76 described his visits to an astrologer, a palm- reader, and a “psychic,” each of whom complimented him, made predictions, and gave specific advice. Based on his experience and reports by others, he concluded: (a) psychics and astrologers see themselves as performing
counseling, and (b) their clients may be people who do not wish to think of themselves as having psychologic or psychiatric problems. Novella77 has noted: The common ploy used by psychics (often called the Jean Dixon effect) is to make dozens of predictions knowing that the more that are made, the better the odds that one will hit. When one comes true, the psychic counts on us to forget the 99% that were way off. This makes the correct predictions seem much more compelling than they really are.
MiSManageMent of pSYchotherapY
Psychotherapy should not only help patients resolve problems but, in most cases, should also help foster independence from the therapist. Just as children must learn to handle situations without always running to their mother, patients must learn to handle upset feelings between sessions without the direct help of the therapist. Therapists who permit or encourage frequent telephone
Simplistic Advice A deep understanding of a patient’s dynamics may enable a therapist to give beneficial advice. But sometimes therapists give advice without considering the complexity of the patient’s situation. Such ill-conceived action may be the result of inadequate training, poor therapeutic technique, or an emotional problem of the therapist. The following composite cases illustrate this point.
A 60-year-old businessman complained of insomnia and depression. Worry about his business was keeping him awake. The physician advised him to take a vacation to “get away from it all so you can stop worrying.” The man went to a seaside resort but found he could not relax. He thought that his business would suffer from his absence, and idleness merely served to intensify his worrying.
A 35-year-old junior executive sought treatment for headaches and abdominal fullness. The physician correctly diagnosed that these were bodily reactions to tension, which was generated primarily at work. The patient believed he was being asked to do more than his share but was afraid to speak up about it. The physician encouraged the man to express his resentment, but failed to discuss how to do this in a constructive manner. The patient “told off” his boss and quit in a huff—a decision he later regretted.
A middle-aged couple who consulted a counselor spent the first two sessions berating each other for one thing after another. Seeing only the hostility in the relationship, the counselor advised them to get a divorce. A more qualified therapist would have realized that they could not have remained together for many years without a positive side to their relationship. The therapist should have terminated the verbal slugfest, explored the posi- tive aspects of the relationship, identified the issues in conflict, and tried to help the couple resolve them.
A 30-year-old homemaker sought help to understand why she became angry with important people in her life, particularly her husband. The therapist encouraged discussion of her childhood, analyzed similarities between her father and her husband, and said: “You get angry with your husband when he reminds you of your father.” Feeling that this information justified her resentment, the patient acted more nastily toward her husband, and their relationship deteriorated. Actually, the marital situation had been far more complex than the therapist realized. He should have explored the patient’s contribution to the marital friction and helped her learn better ways to handle her feelings. Joint sessions with the patient and her husband might have helped the therapist understand the situation better.
Personal Glimpse
Part Two Health-Care Approaches108
calls encourage overdependence. Therapists who receive many such calls from many patients are likely to have an underlying problem, such as a neurotic need to have people depend on them, which impairs their ability to treat patients. A more subtle example of this problem is the therapist who cannot adhere to a schedule. Patients are scheduled for particular times, but sessions are allowed to run considerably overtime when patients are upset or appear to be talking about particularly meaningful material. Although an occasional brief extension may be justified, a general policy of this type encourages patients to manipulate the therapist to gain more atten- tion. The Consumer Health Insight box lists other signs that a therapist is improperly crossing patient-therapist boundaries. The most malignant type of therapist behavior is probably sexual exploitation. Although it is not unusual
for the therapist and patient to feel a personal or physical attraction toward each other, acting on such feelings is not therapeutic.78 Nearly all well-trained therapists be- lieve that sexual contact with a patient is inappropriate and usually harmful. A composite case history illustrates what can happen:
An unmarried 27-year-old woman entered therapy to over- come shyness, feelings of inadequacy, and fear of involvement with men. Few men had seemed interested in her, and she had rarely dated. As therapy proceeded, she became extremely fond of the therapist, based largely on the fact that he was the first man who had spent time with her on a regular basis. At this point, instead of helping her learn how to attract suitable dates, the therapist suggested that sex with him would help her become more comfortable with men. She consented, hop- ing that marriage to the therapist would result. Her eventual disillusionment was a shattering experience that led to suicide.
Several states have laws forbidding such contact. In some states it is a criminal offense, and in others it is considered malpractice and can lead to a loss of license. In 1990 a California jury awarded $1.5 mil- lion to a woman who said she had been exploited by a psychiatrist who had treated her. Testimony during the trial indicated that they had begun dating after almost 2 years of treatment. The patient said that although she was extremely happy during the beginning of their af- fair, she became severely depressed when it ended.79 In 1993 the American Psychiatric Association’s board of trustees declared that “sexual activity with a current or former patient is unethical.”
SuMMarY
Although excellent help is available for the treatment of mental and behavioral problems, selecting a suitable therapist can be difficult. Some people respond best to a conversational approach, some to medication, and some to both. Before seeking treatment, it is advisable to un- derstand the types of help available and the training that various types of practitioners undergo. Although most practitioners with accredited training are competent, some engage in practices that are unscientific or reflect underlying problems of their own. For this reason, con- sumers should also be able to recognize the common signs of inappropriate therapy.
referenceS
1. U.S. Department of Health and Human Services. Mental Health: A Report of the Surgeon General. Washington D.C., 1999, U.S. Government Printing Office.
2. Lilienfeld SO. Our raison d’être. The Scientific Review of Mental Health Practice 1:1–10, 2002.
Consumer Health Insight
Boundary Violations
Signs that a therapist is improperly crossing the pa- tient-therapist boundary include:
• Repeatedly touching or hugging the patient • Nontherapeutic contact outside of the therapist’s
office • Hiring the patient or using the patient as an un-
paid volunteer • Talking about other patients • Disclosing personal problems or intimate details
of personal life, such as sexual experience • Giving or accepting a valuable gift or loan • Addressing the patients with a pet name • Dressing seductively • Ignoring mounting unpaid bills for treatment • Offering not to charge or to greatly reduce fees,
even when the patient can afford the cost • Permitting a patient to run errands or do other
small favors for the therapist • Using data from a therapy session (such as inside
knowledge of a good investment) for personal gain
• Spending time—and wasting the patient’s money—talking about the therapist’s problems
• Promoting the therapist’s religious belief system • Promoting involvement in a social or political
cause that the therapist likes • Offering to join the patient in an investment or
business venture • Encouraging patients to engage in cultlike behav-
ior with the therapist as a guru
Chapter Six Mental and Behavioral Help 109
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26. Greenwald AG and others. Double-blind tests of subliminal self-help audiotapes. Psychological Science 2:119–122, 1991.
27. Bjork RA and others. In the Mind’s Eye. Enhancing Human Performance. Washington D.C., 1991, National Academy Press.
28. Randolph-Seng B, Mather RD. Does subliminal persuasion work? It depends on your motivation and awareness. Skeptical Inquirer 33(5): 49-53, 2009.
29. Gubernick L, Mao P. The happiness hucksters. Forbes Oct 9, 1995, pp 82–88.
30. Stehlin IB. Unapproved devices seized. FDA Consumer 29(7):32-33, 1995.
31. Unapproved ‘brain wave’ devices condemned after seizure reports. FDA Consumer 28(2):41–43, 1994.
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33. Beyerstein BL. Brainscams: Neuromythologies of the New Age. International Journal of Mental Health 19(3):27–36, 1990.
Should you or a family member need help with an emotional or mental problem, which of the following would you do? Reason
Explore the Internet _______________________ Ask a local physician for help _______________________ Check with a religious counselor _______________________ Call the local health department _______________________ Discuss the matter with your spouse or a friend _______________________ Take large amounts of vitamins _______________________ Other: (specify) ______________________ _______________________
Should you or a family member have an alcohol problem, what action(s) would you take? Reason
Check with a religious counselor _______________________ Call one of the self-help groups in the community _______________________ Talk with a family relative or friend _______________________ Talk with a family member about obtaining help _______________________ Call your local physician _______________________ Other: (specify) ______________________ _______________________
It’s Your Decision
Part Two Health-Care Approaches110
34. Carroll R. Large group awareness training program. Skeptics Dictionary Web site, Nov 7, 2011.
35. Princeton Brain Bio Center. Brochure distributed to patients. Skillman, N.J., 1983, The Center.
36. Lipton M and others. Task Force Report on Megavitamin and Orthomolecular Therapy in Psychiatry. Washington D.C., 1973, American Psychiatric Association.
37. Nutrition Committee, Canadian Paediatric Society. Megavita- min and megamineral therapy in childhood. Canadian Medical Association Journal 143:1009–1013, 1990. Reaffirmed April 2000 and March 2004.
38. Committee on Nutrition, American Academy of Pediatrics. Megavitamin therapy for childhood psychoses and learning disabilities. Pediatrics 58:910–912, 1976.
39. The Feingold Association of the United States. The Feingold Handbook. Alexandria, Va., 1986.
40. Wender EH, Lipton MA. The national advisory committee report on hyperkinesis and food additives—final report to the Nutrition Foundation. Washington D.C., 1980, The Nutrition Foundation.
41. Barrett S. The Feingold diet: Dubious benefits, subtle risks. Quackwatch Web site, March 15, 2004.
42. Wolraich ML and others. Effects of diets high in sucrose or as- partame on the behavior and cognitive performance of children. New England Journal of Medicine 330:301-307, 1994.
43. Wolraich ML and others. The effect of sugar on behavior or cognition in children: A meta-analysis. JAMA 274:1617-1621, 1995.
44. American Academy of Pediatrics Committee on Children with Disabilities. Auditory integration training and facilitated com- munication for autism. Pediatrics 102:431-433, 1998.
45. Executive Committee, American Academy of Audiology. Au- ditory integration training and facilitated communication for autism. Audiology Today 5(4):21, 1993.
46. Barrett S. How the urine toxic metals test is used to defraud patients. Quackwatch Web site, July 29, 2010.
47. Williams KW. Intravenous secretin for autism spectrum disorder. Cochrane Database of Systematic Reviews 3:CD003495, 2005.
48. Tsouderos T. ‘Miracle drug’ called junk science: Powerful cas- tration drug pushed for autistic children, but medical experts denounce unproven claims. Chicago Tribune, May 21, 2009.
49. American Academy of Pediatrics. Policy statement: The Doman- Delacato treatment of neurologically handicapped children. Pediatrics 70:810–812, 1982.
50. Lilienfeld SO. EMDR treatment: Less than meets the eye. Quackwatch Web site, April 17, 2011.
51. Lohr JM and others. Efficacy of eye movement desensitization and reprocessing: Implications for behavior therapy. Behavior Therapy 29:126 –153, 1998.
52. Mulick JA and others. Anguished silence and helping hands: Autism and facilitated communication. Skeptical Inquirer 17:270–280, 1993.
53. Wheeler DL and others. An experimental assessment of facili- tated communication. Mental Retardation 31:49-59, 1993.
54. American Psychological Association. Facilitated communica- tion not a scientifically validated technique for individuals with autism or mental retardation. News release, August 24, 1994.
55. Cooke P. The Crescent City cure. Hippocrates 2(6):61–70, 1988.
56. Lilienfeld SO and others. Great Myths of Popular Psychology.: Shattering Widespread Misconceptions about Human Behavior. West Sussex, UK, 2010, Wiley Blackwell.
57. Metzger RL, Werner DB. Use of visual training for reading disabilities. Pediatrics 73:824-829, 1984.
58. Druckman D, Swets JA, editors. Enhancing Human Perfor- mance. Washington D.C., 1988, National Academy Press.
59. Mercer J and others. Attachment Therapy on Trial: The Torture and Death of Candace Newmaker. Westport, Conn., 2003, Praeger Publishers.
60. Reactive attachment disorder: Position statement. American Psychiatric Association, June 2002.
61. Spanos NP. Past-life hypnotic regression: A critical view. Skepti- cal Inquirer 12:174–180, 1988.
62. Baker RA. Hidden Memories: Voices and Visions from Within. Amherst, N.Y., 1992, Prometheus Books.
63. Guadiano BA, Herbert JD. Can we really tap our problems away? A critical analysis of thought field therapy. Skeptical Inquirer 24(4):29–33, 2000.
64. US Churches of Scientology. New viewpoints. Los Angeles, 1976, The Church.
65. Hubbard LR. Dianetics: The Modern Science of Mental Health. Los Angeles, 1992, Bridge Publications.
66. Workbook on How to Use Dianetics. Los Angeles, 1992, Golden Era Productions.
67. Behar R. The thriving cult of greed and power. Time 137(18):50– 57, 1991.
68. Gesell G. Memorandum opinion. United States v Hubbard E-Meter, Founding Church of Scientology, and others. U.S. District Court for the District of Columbia, 333 F(supp)357, July 30, 1971.
69. Food Drug Cosmetic Reports. United States v Hubbard E-Meter, p 842, Mar 12, 1973.
70. Hubbard LR. Clear Body, Clear Mind. Los Angeles, 1990, Bridge Publications.
71. Accomplishments of the Citizens Commission of Human Rights. CCHR Web site, accessed Dec 2011.
72. The rise of senseless violence in society: Psychiatry’s role in the creation of crime. Los Angeles, 1992, Citizens Commission on Human Rights.
73. Creating racism: Psychiatry’s betrayal. Los Angeles, 1995, Citizens Commission on Human Rights.
74. Quick facts about psychiatry. CCHR Web site, accessed Aug 2010.
75. Lilienfeld SO. Projective measures of personality and psy- chopathology. How well do they work? Skeptical Inquirer 23(5):32–39, 1999.
76. Lester D. Astrologers and psychics as therapists. American Journal of Psychotherapy 36:56–66, 1982.
77. Novella R. The power of coincidence. Quackwatch Web site, Aug 31, 2000.
78. Gutheil TG, Gabbard GO. The concept of boundaries in clinical practice: Theoretical and risk-management dimensions. Ameri- can Journal of Psychiatry 150:188-196, 1993.
79. Rubsamen D. Psychiatrist’s seduction of patient results in $1.5 million jury verdict. Psychiatric News, p 15, Mar 15, 1990.
Dental Care
The majority of dentists work in the privacy of their own office, where they usually are not subject to review by knowledgeable colleagues. This situation, plus the fact that the harm done by poor dental care may not become apparent for many years, makes it difficult for consumers to evaluate the quality of the treatment they receive. John E. DoDEs, D.D.s.1
Chapter Seven
© 1980 stephen barrett, m.d.
Part Two Health-Care Approaches112
Dental diseases are among the most prevalent ail- ments in the United States. The total cost of dental services in 2009 was about $110 billion.
Tooth decay (caries) affects nearly everyone. Periodon- tal (gum) disease results in greater tooth loss than any other cause. Although proper care enables most teeth to last a lifetime, about 25% of Americans older than 65 are toothless. Misconceptions about dental disease are common. Misinformation is spread by advertisers, food faddists, the media, and misguided or poorly informed health professionals. This chapter covers the causes, prevention, and treatment (both appropriate and inappropriate) of dental problems. Tobacco products, which can adversely affect tissues in the mouth, are discussed in Chapter 14. Dental insurance is covered in Chapter 23.
Dentists
Dentists are licensed practitioners who hold either a doc- tor of dental surgery (D.D.S.) degree or the equivalent doctor of dental medicine (D.M.D.) degree. Becoming a dentist requires a minimum of 2 years of predental college work followed by 4 years of dental school. However, almost all students entering dental school have a baccalaureate degree. There are 57 accredited dental schools in the United States. The first 2 years of dental school consist largely of basic and preclinical sciences. The last 2 years are spent primarily in dental practice under faculty supervision. State licensure is then acquired by passing a combination of national and either state or regional examinations. Dentists who wish to specialize spend 2 or more years in advanced training. To become board-certified they must then pass an ex- amination administered by a specialty board recognized by the American Dental Association (ADA). The nine recognized specialties are:
DEntal public hEalth: Promotion of community dental health
EnDoDontics: Prevention and treatment of diseases of the root pulp and related structures (root canal therapy)
oral anD maxillofacial pathology: Diagnosis of tumors, other diseases, and injuries of the head and neck
oral anD maxillofacial raDiology: Radiologic diagnosis and treatment of head and neck disorders
oral anD maxillofacial surgEry: Tooth extractions; surgical treatment of diseases, injuries, and defects of the mouth, jaw, and face
orthoDontics anD DEntofacial orthopEDics: Diagnosis and correction of tooth irregularities and facial deformities
pEDiatric DEntistry: Dental care of infants and children pErioDontics: Treatment of diseases of the gums and related
structures prosthoDontics: Treatment of oral dysfunction through the
use of prosthetic devices such as crowns, bridges, and dentures
Some dentists claim to specialize in “cosmetic den- tistry,” but this is not a recognized specialty. The ADA estimates that during 2006, 180,000 den- tists were professionally active in the United States, with about 165,000 in private practice. About 75% of dentists are ADA members.
allieD Dental Personnel
The services of dentists are complemented by dental assistants, registered dental hygienists, and dental labo- ratory technicians. Dental assistants have been part of the dental health- care team since 1885. The duties they may legally per- form vary from state to state and can depend on the extent of their training. They may include preparing patients and materials, sterilizing instruments, keeping records, and taking x-ray films. Many assistants are trained by the dentists who employ them. Others have taken a short
• Good teeth contribute not only to appearance but to the quality of life as well.
• The key to dental health is prevention, the cornerstones of which are good oral hygiene and fluoride.
• Community water fluoridation is the most effective and cost-effective way to obtain adequate fluoride intake.
• With proper care, teeth should last a lifetime. Self-care should involve daily brushing and flossing. The frequency of dental visits should be based on an assessment of cavity formation, the rate of calculus deposition, the condition of the gums, an individual’s specific needs, and any related medical issues.
• Dentists who routinely recommend removal of amalgam fillings or teeth that have undergone root canal therapy are not trustworthy and should be avoided.
KeeP these Points in MinD as You stuDY this ChaPter
Key Concepts
Chapter Seven Dental Care 113
commercial course or received special training for ex- panded functions. The Certified Dental Assistant (CDA) credential, administered by the Dental Assisting National Board, is recognized or required in more than 37 states. Candidates may qualify for the certification examina- tion by graduating from an accredited dental assisting education program or by having 2 years of full-time or 4 years of part-time experience as a dental assistant. The requirements for taking x-rays films or doing other advanced procedures vary from state to state.2
Registered dental hygienists (RDHs) provide clini- cal and educational services in private dental offices, schools, industrial plants, and public health and other government agencies. Their activities include perform- ing oral prophylaxis (cleaning and polishing teeth), taking and processing x-ray films, conducting caries screening, and teaching oral health care. The training of dental hygienists takes 2 years for an Associate of Arts (AA) or Associate of Science (AS) degree. There are also bachelor (BS-DH).and Master of Science (MS-DH) programs. After completing the National Board of Dental Hygiene Examination, they must pass a state or regional examination for licensure, which also entitles them to use the RDH credential. The scope of dental hygiene practice varies from state to state and has gradually expanded. Dental laboratory technicians are trained to con- struct and repair oral appliances such as crowns, bridges, and dentures. Training in dental laboratory technology is available through universities, community and junior colleges, vocational-technical institutes, and the Armed Forces. In 2008, 20 programs were accredited by the Commission on Dental Accreditation in conjunction with the ADA. Most such programs take 2 years to complete; a few can take up to 4 years.3 Certification is available from the National Board for Certification in Dental Laboratory Technology. Certified Dental Tech- nicians (CDTs) specialize in one or more of five areas: complete dentures, removable partial dentures, crowns and bridges, ceramics, and orthodontics. Dental laboratory technicians usually work under a dentist’s direction, either in the dentist’s office or in a commercial laboratory. Those who work independently, selling directly to the public, are referred to as denturists. Denturism is illegal in most states.
tooth DeCaY
Figures 7-1 and 7-2 show the names and locations of the teeth and their component parts. Tooth decay (dental caries) is caused by bacteria in the mouth that produce acids harmful to tooth enamel. It is a highly complex phenomenon that involves the interaction of hereditary
factors, specific cariogenic bacteria, nutritional factors, dietary habits, oral hygiene, and time. Some medications and abused drugs can also cause caries. Various studies suggest that caries can be reduced by decreasing the number of decay-producing bacteria in the mouth. New caries is especially common during adolescence. Although sugar consumption has an effect on dental caries, the amount of sugar in the diet is not as important as the frequency of eating, the acid-buffering capacity of the saliva, whether the sugar is in a food that sticks to the teeth, the availability of fluoride, and the individual’s oral-hygiene practices. Food faddists teach that honey, raw sugar, and other “natural” sweets are nutritionally superior, and that
Figure 7-2. Schematic cross-section of an incisor tooth in its bony socket.
Enamel Dentin
Gum
Root canal containing nerves and blood vessels
Bone (jaw)
Crown
Root (portion below the gum)
Pulp (nerves and blood)
Figure 7-1. Schematic drawing of adult teeth. The upper teeth are numbered as shown. The lower teeth are numbered from #17 (under #16) to #32 (under #1).
Modified from Thibodeau GA, Patton KT. Anatomy and Physiology, ed 3. St. Louis, 1996, Mosby.
Front view of upper teeth, mouth open
Second premolar
Upper incisor
Canine
First premolar
Central incisor
First molar
Second molar
Third molar (wisdom tooth)
1 16
2
3
11 10987
6 5
4
15
12 13
14
LEFTRIGHT
Part Two Health-Care Approaches114
white sugar is bad because it is “empty calories.” They also suggest that natural sugars are less apt to produce tooth decay. Both of these ideas are false. The vitamin content of natural sugars is minuscule. Honey is at least as cariogenic as refined sugar (sucrose) in the same con- centration. The faddists’ suggestion to substitute granola for conventional presweetened cereals is also foolish. (Granolas are made with oats, honey, dried fruit, and brown sugar.) Decay-causing germs make no distinction between sugars from different sources. They digest them all and produce acids that attack (demineralize) tooth structures. The more often a person eats between meals and the longer fermentable carbohydrates remain in contact with the teeth (as sticky sweets are most prone to do), the more the teeth are subjected to demineralization. Remineralization (healing) occurs between periods of acid exposure and is aided by fluoride ions and other substances in saliva. Whether decay occurs depends on whether demineralization exceeds remineralization. Tooth damage has been reported in users of vitamin C (ascorbic acid) tablets who chew rather than swallow them. Ascorbic acid is strong enough to erode tooth enamel over a period of time.4 Acid erosion can also be caused by frequent vomiting (pregnancy or bulimia) or high-acid foods (e.g., sucking on lemons). “Baby bottle tooth decay” is a condition of early childhood in which cavities develop in teeth that have prolonged contact with sugar-containing fluids. To pre- vent it, infants and toddlers should not be permitted to (a) sleep or walk around with a bottle filled with milk, formula, juice, or sweetened drink in their mouth, (b) sleep at night at the breast, or (c) use a pacifier that has been dipped in honey, syrup, or other sweet fluid.
Dental Sealants Sealants are thin plastic coatings that can protect the chewing surfaces but not the sides of the back teeth (molars) from decay. Sealants fill the pits and fissures of the chewing surfaces and harden soon after application. They usually last for years and can be reapplied if neces- sary. They are most effective between the ages of 5 and 14 when applied soon after the permanent teeth erupt. The American Academy of Pediatric Dentistry5 advises:
The natural flow of saliva usually keeps the smooth surfaces of teeth clean but does not wash out the grooves and fissures. So the teeth most at risk of decay—and therefore, most in need of sealants—are the six-year and twelve-year molars. Many times the permanent premolars and primary molars will also benefit from sealant coverage. Any tooth, however, with grooves or pits may benefit from the protection of sealants.
FluoriDation
Fluoride, an ion found naturally in most water supplies. can prevent the formation, slow the progression, and even reverse newly forming cavities. When sufficient quantities of fluoride are available, especially during the process of tooth development, the resultant teeth are stronger and more resistant to decay.6
In the early 1900s a Colorado dentist named Fred- erick McKay suspected that something in water caused brown stains on the teeth of members of his community. The mottled teeth also were remarkably free of decay. By 1931 a new technique for water analysis enabled Dr. McKay to identify high fluoride as the cause. Subsequent testing determined that the ideal concentration for pre- vention of caries without mottling is approximately one part of fluoride per million parts of water.7
The first community fluoridation program began in 1945. Today more than 160 million people in the United States are served by community fluoridation and about 10 million more have protective levels of naturally occurring fluoride in their water. Recognition of fluo- ride’s importance to dental health has led to dramatic declines in the prevalence and severity of tooth decay. Government surveys have found that the percentage of children with caries-free permanent teeth rose from 28% in 1971–1974 to 36.6% in 1979–1980 and 49.9% in 1986–1987.8,9
In 1999, the U.S. Centers for Disease Control and Prevention listed water fluoridation as among the 10 greatest health achievements of the 20th century.10,11
Fluorides also work when applied to the surfaces of the teeth. This occurs through fluoride in saliva (due to ingested fluoride) and through the use of fluoride toothpaste, mouth rinse, gel, and/or varnish.
Unfounded Criticism Strident claims have been made that fluoridation causes cancer, birth defects, Down syndrome, allergies, and a wide variety of other maladies. But none of these claims has held up to scrutiny by qualified scientists.12–17 Former National Council Against Health Fraud president Wil- liam T. Jarvis, Ph.D., has noted:
These charges seem to grow out of a mentality of distrust. Antifluoridation groups are led by many of the same people who oppose immunization, pasteurization, sex education, mental health programs, and other public health advances. Most are closely connected with sellers of alternatives to medically accepted products and services. The so-called “health food” industry justifies its existence by declaring that our conventional sources of food, water, and health care are not trustworthy.
Chapter Seven Dental Care 115
Too much fluoride can cause fluorosis, which, in its mildest form, causes small, white, virtually invisible opaque areas on teeth. Severe fluorosis causes brownish mottling, which occurs mainly in areas where the natural level of fluoride in water is considerably greater than one part per million. (Severe fluorosis also occurs in certain diseases, but this is not relevant to fluoridation.) For many years, a pamphlet called “Lifesavers Guide to Fluoridation,” was distributed in communities considering fluoridation. The pamphlet cited more than 200 references to back up its claims that fluoridation was ineffective and unsafe. However, experts who examined the references found that nearly half had no relevance to community water fluoridation and that many others actu- ally supported fluoridation but were misrepresented.14
A more recent review concluded:
Opponents of water fluoridation frequently repeat that water fluoridation is associated with adverse health effects. . . . Tech- niques such as “the big lie” and innuendo are used to associate water fluoridation with health and environmental disasters, without factual support. Half-truths are presented, fallacious statements reiterated, and attempts are made to bamboozle the public with a large list of claims and quotes often with little scientific basis. Ultimately, attempts are made to discredit and slander scientists and various health organizations that support water fluoridation.15
Fluoride Supplementtion Fluoridation reduces the incidence of cavities 20% to 40% in children and 15% to 35% in adults.16 The reduction is less than it was during fluoridation’s early days, probably because of improved dental hygiene and widespread use of fluoride toothpaste. Children in areas with negligible amounts of fluoride in the drinking water should be given fluoride drops or tablets prescribed by a physician or dentist. Table 7-1 gives the recommended dosage. Children who drink adequately fluoridated water should not be given supplements.
When supplements are given conscientiously from infancy through early adolescence, the level of caries protection approaches that of water fluoridation. How- ever, because few parents have sufficient motivation to carry out such a program, water fluoridation is vastly superior as a public health measure. Topical methods apply fluoride directly to the surfaces of the teeth. They have merit but are not as ef- fective as ingested fluorides that are incorporated into the tooth structure as it forms. Fluoride toothpastes and mouth rinses are available for individual use; gels, pastes, varnishes, and solutions are available for administration by dentists. Topical fluoride methods can be used in nonfluoridated communities and also offer additional caries protection in fluoridated communities. The most rigorous study of preventive dental inter- ventions, the National Preventive Dentistry Demonstra- tion Program, monitored nearly 30,000 children, ages 5 to 14, for four years. It concluded that the most effective and cost-effective way to prevent tooth decay is to drink fluoridated water from birth and have sealants applied as recommended.16
The average annual per-person cost for community fluoridation now ranges from about 50¢ in large com- munities to $3 in small ones. For most cities, every dollar invested saves about $38 in dental treatment costs.17
PerioDontal Disease
“Periodontal disease” is the general term for inflamma- tory and degenerative diseases of the gums and other structures that surround the base of the teeth. A common cause of tooth loss between the ages of 30 and 70, it is usually triggered by accumulation of plaque (a soft, sticky, almost invisible film) under the gum. There are several types of periodontal disease, all resulting from bacterial infection that attacks the gums, bone, and ligaments that hold the teeth in the jaw.
Concentration of fluoride in water (parts per million)
Age (years) 0.0 to 0.3 0.3 to 0.6 Over 0.6 Birth to 6 months None None None 6 months to 3 years 0.25 mg/day None None 3 to 6 years 0.50 mg/day 0.25 mg/day None 6 to 16 years 1.00 mg/day 0.50 mg/day None
suPPleMental FluoriDe Dosage (MilligraMs oF FluoriDe Per DaY)* Table 7-1
*2.2 mg of sodium fluoride contains 1 mg of fluoride. Includes nursing infants who usually consume little exogenous water. Commercial formulas contain no fluoride. Recommended since 1994 by the American Dental Association and the American Academy of Pediatrics.18
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Without adequate bone and connecting fibers, the teeth loosen and are lost. The earliest stage of periodontal disease is gingivitis, which develops when the bacteria in plaque release toxins that irritate the gums, making them red, tender, swollen, and likely to bleed. The next stage, periodontitis, occurs when toxins destroy the tissues anchoring the teeth to the bone. Gums become detached from the teeth, forming pockets that fill with more plaque. In advanced cases the gums are red and swollen and ooze pus (pyorrhea), painful abscesses may occur, and the teeth lose attachment as the supporting bone is destroyed. Without treatment, teeth can fall out or require removal by a dentist. Diabetics, who are prone to develop infections, are also at higher risk for developing periodontal disease.19
Brushing, flossing, and periodic dental care are the first lines of defense against periodontal disease—as they are against caries. Tobacco avoidance is another important strategy because tobacco use greatly increases the risk of developing gum disease. Adequate daily oral hygiene can prevent or minimize periodontal disease. Gingivitis is evidenced by redness or bleeding of the gums without discomfort. Pink color- ing on the toothbrush bristles may be the first clue that gingivitis is present. Many adults have gingival and early periodontal disease. Because the tissue damage in the later stages of periodontal is not reversible, it is imperative that early signs be recognized and treated even if they cause no discomfort. Surface plaque can be identified with a disclosing solution or tablet. These agents dye the plaque a bright color (usually red) and highlight areas that are missed during cleaning of the teeth. If plaque is allowed to re- main on the teeth, it can harden to form calculus (also called tartar or scale). Calculus is a gum irritant and can host bacteria that cause periodontal disease. Brush- ing with a dentifrice can reduce the amount of calculus above the gumline but not below it. Once calculus has built up, professional scaling is necessary to remove it. Tooth cleaning by a dentist or dental hygienist is advisable at least once a year to remove calculus, which reduces the risk of periodontal disease. Yet many people won’t go to a dentist unless they have troublesome symptoms. Properly performed professional cleaning is a meticulous procedure in which all the calculus, above and below the gumline, is carefully removed with metal instruments called scalers. An ultrasonic device can be used to remove calculus, but its use should be followed with hand-scaling to ensure that the teeth are clean and smooth. The teeth are polished after the scaling. In the late 1970s an oral hygiene program called the Keyes technique was widely promoted as a nonsurgical
alternative for treating advanced periodontal disease. The technique includes microscopic examination of the plaque and cleaning the teeth and gums with a mixture of salt, baking soda, and peroxide. Several studies have shown that surgical treatment is more effective. One study found that although the baking soda mixture helped maintain oral health, it was no more effective than ordi- nary toothpaste. The researchers also found that people using the baking soda regimen were three times as likely to stop their program because it was inconvenient. The American Academy of Periodontology has concluded that the Keyes technique did not appear to provide added value over conventional periodontal therapy and was inferior in some instances.20
selF-Care
Although individuals can greatly influence their oral health, many people do not take dental problems seri- ously until it is too late. Losing teeth may not be as serious as losing an eye, a hand, or a foot, but people who lose their teeth are handicapped. Dentures are not as comfortable or functional as normal, healthy teeth and can cause difficulty in eating, as well as adverse psychologic effects.
Brushing and Flossing Teeth should be cleaned to remove plaque—the soft, sticky, colorless film of bacteria that is constantly forming on their surface. Acids and toxins produced by these bacteria are a major factor in both tooth decay and periodontal disease. The quantity and destructive character of plaque change with the passage of time. It takes about 24 hours for plaque to become sufficiently concentrated to begin causing damage. Pits, fissures, and areas between the teeth where toothbrushes cannot reach provide hideouts for plaque and thus are the sites of most dental problems. One thorough daily cleaning, involving both brush- ing and flossing, is usually sufficient to break up the colonies of bacteria that are continuously being built. A fluoridated dentifrice should be used. The ADA21 advises brushing twice daily. Brushing after meals is primarily for the purpose of dislodging food particles and should be accompanied by rinsing of the mouth. Myth of “Detergent Foods” The idea that eating crunchy foods such as apples and carrots helps to clean the teeth by removing plaque is a myth. At best, chewing can affect plaque on the upper third of the teeth. Areas under the gums where periodon- tal disease occurs are completely unaffected.
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Dental ProDuCts
The ADA performs independent reviews of commonly used commercial dental products. Those judged to be safe and effective are permitted to carry a statement of ADA acceptance on their packages and in their advertis- ing (Figure 7-3).
Toothpastes and Gels (Dentifrices) Dentifrices commonly contain abrasives, binding agents, sudsers, coloring agents, moisturizers, sweeteners, preservatives, and water. Many contain a fluoride com- pound. A dentifrice should be abrasive enough to prevent plaque and stain accumulation but not so harsh that it injures teeth or gums.22 The more abrasive toothpastes have little effect on the hard enamel in teeth but can damage the cementum (the soft layer of the tooth just under the gum). As a person gets older, the gums may recede and expose the cementum to possible damage by abrasion. Some products can also irritate the gums themselves. Fluoride dentifrices inhibit dental caries even in adults. They are not a substitute for the fluoridation of community drinking water but are a useful adjunct. Many have been accepted by the ADA Council on Dental Therapeutics as “an effective decay preventive dentifrice that can be of significant value when used in a conscientiously applied program of oral hygiene and regular professional care.” Dentists can recommend fluoride-containing products that are within the proper range of abrasiveness based on their patients’ individual needs. Some dentifrice advertisements make claims about whitening and brightening of teeth. The basic color of the teeth is determined early in life and cannot be made whiter. Abrasive toothpastes may remove minor tooth discoloration caused by substances taken into the mouth, but these toothpastes can easily damage the softer parts
of the teeth. Toothpastes and whitening strips containing urea peroxide or hydrogen peroxide can exert bleaching action. However, the wisest course of action for consum- ers who are concerned about tooth discoloration is to discuss the matter with their dentist. If gums recede so that cementum is exposed, the teeth can become sensitive. Use of a dentifrice that contains potassium nitrate (e.g., Sensodyne) lessens this sensitivity in some people.23 Oher treatments to desen- sitize teeth are available from dental practitioners.
Fluoride Mouth Rinses The ADA Council on Dental Therapeutics has ac- cepted several nonprescription fluoride mouth rinses as “effective decay-preventive rinses that can be of significant value when used regularly in conjunction with a decay-preventive fluoride dentifrice in a consci- entiously applied program of oral hygiene and regular professional care.” These can be helpful to people who live in nonfluoridated communities or whose teeth are very susceptible to decay.
Toothbrushes Most dentists suggest a flat brushing surface with tufts of about equal length throughout the brush and a head small enough for comfort, regardless of the number of rows. The head of the brush must be small enough to reach all important surface areas of the mouth. Soft nylon bristles are flexible, clean teeth efficiently, and usually do not damage the gums. These bristles can make contact below the gum margin to help remove plaque. Toothbrushes with hard bristles should not be used because they can damage the teeth and gums, especially when combined with a highly abrasive toothpaste. To be effective, a brush must be manipulated properly. For manual brushing, the brush should be vibrated with the bristles positioned at a 45-degree angle against the gums so that one row of
Figure 7-3. The ADA Seal of Acceptance. This logo, which signifies that a product meets ADA standards of safety and effectiveness, can be displayed in ads and on product labels and packages. More than 1300 over-the-counter and professional products are involved. Participating manufacturers must submit the products for expert evaluation and agree to have their advertising preapproved. Since 1994, this program has been administered by the ADA Council on Scientific Affairs. The ADA Web site has monographs for more than 300 consumer products at www.ada.org/seal.
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bristles can slip slightly under the gum. All tooth surfaces should also be brushed twice a day. Electric toothbrushes are useful but are not pana- ceas. Careful manual brushing can be just as effective as mechanical brushing, although some studies report that certain electric toothbrushes remove plaque more efficiently than manual brushing. An electric toothbrush is particularly helpful for people with poor coordination caused by mental or physical disabilities, patients with orthodontic bands on their teeth, or people who are un- willing to spend sufficient time for proper brushing by hand. In recent tests, Consumer Reports 24 found that its top-rated Oral-B Triumph Professional Care 9400 and the Phillips Sonicare FlexCare R910 removed 75% of plaque. Consumers Union’s consultants advise replacing one’s toothbrush every 3 months because worn bristles are less effective at removing plaque. “Toothbrush sterilizers” have no practical value because there is no danger from using a toothbrush that carries germs from one’s own mouth.
Interdental Cleaners Although the toothbrush is successful in removing plaque at exposed surfaces, it cannot completely clean the surfaces between the teeth. Optimal oral hygiene requires something that can penetrate between adjacent teeth. The products designed to do this include floss, woodsticks, rubber-tip simulators, interdental brushes, and irrigators. Dental floss comes waxed or unwaxed. Although many dentists recommend the unwaxed type as better for removing plaque, people with closely spaced teeth may find it easier to use the waxed type. The important point is to floss daily in the manner prescribed by the dentist or dental hygienist. Floss holders are available for people who have difficulty manipulating the floss by hand. When teeth are hard to floss because of bridgework or gum recession, dentists may recommend a specially shaped toothpick (such as Stim-u-dent) or a rubber in- terdental tip to supplement dental floss. Interdental brushes are small, specially designed brushes for cleaning between the teeth. They have soft nylon filaments twisted into a fine stainless steel wire. They are suitable for use by patients with sufficient space between their teeth.25 Oral irrigating devices use a direct spray of water to remove loose food particles and other large materials from around the teeth. Oral irrigators cannot substitute for either brushing or flossing, but patients with orth- odontic bands, a fixed bridge, or excessive spacing
between the teeth may find them helpful. Incorrect use of an irrigating device can injure oral tissues. For this reason, persons using such devices should get instruc- tions from their dentist about proper use. Sugarless Gum Chewing gum that contains sugar can contribute to tooth decay. Thus sugar-free gum is a better choice for people who chew gum frequently. Gums that contain xylitol can help decrease the risk of decay.26 Xylitol, a sugar alcohol, inhibits the growth and acid-forming ability of the bacteria (Mutans streptococci) that contribute to tooth decay. The American Academy of Pediatrics (AAP) recommends that pregnant women chew xylitol gum or mints 4 times a day to prevent or delay transmission of these bacteria to their infants. The American Academy of Pediatric Dentistry recommends that young children use the gum, but the AAP is concerned about the risk of choking and has not endorsed the practice.27
Mouthwashes Advertising has suggested that mouthwashes are effec- tive against bad breath (halitosis), can help clean the teeth, prevent or treat colds and sore throats, and help control dental plaque. Many such promotions have been misleading. Mouthwashes can freshen the breath for a few min- utes (sometimes as much as an hour), but they cannot prevent infectious diseases. Those that kill bacteria may reduce bad breath if used regularly.28 Some mouth- washes have a high alcohol content, which can cause excessive drying of the mouth. People who are troubled with bad breath should understand that this is a symptom whose cause, whether oral or systemic, should be ascertained. The common causes of halitosis include poor oral hygiene; postnasal drip; gum disease; tobacco use; and consumption of gar- lic, onions, certain alcoholic beverages, or other aromatic substances that are exhaled from the lungs and are not subject to modification by mouthwash. Halitosis can also be a symptom of infections, tumors, diabetes, and various other diseases. For many years—until stopped by federal enforce- ment actions—manufacturers suggested in their ads that mouthwashes could help prevent or cure infections. It is true that antiseptic mouthwashes can kill some germs on contact, but this has not been proven to prevent in- fections. Germs in the tiny crevices in the mouth and within infected tissues cannot be reached or washed out. Germs that are washed off the surface of infected areas are quickly replaced.
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The plaque-control situation is less clear-cut. In 1986 the FDA approved Peridex mouth rinse, a prescription drug that contains 0.12% chlorhexidine, as safe and effective in helping to control plaque. Chlorhexidine, which has antibacterial action, can reduce plaque be- low the gumline. In 1987 the ADA Council on Dental Therapeutics concluded that: “Listerine Antiseptic has been shown to help prevent and reduce supragingival (above the gumline) plaque accumulation and gingivitis when used in a conscientiously applied program of oral hygiene and regular professional care. It has not been shown to have a therapeutic effect on periodontitis.” Listerine (a nonprescription product), which works mainly by washing away bacteria, has little or no effect on plaque below the gumline and is not nearly as effec- tive as Peridex. Mouthwashes are not substitutes for brushing and flossing and are appropriate mainly for individuals under dental care in which other measures are unable to control gingivitis. Plax, another mouthwash claimed to reduce plaque, uses sodium benzoate as its principal ingredient. A 2002 meta-analysis concluded that although Plax use appeared to offer some benefit in plaque and gingivitis reduction, the effect and benefit on oral health are likely to be small.29
Some studies have suggested that mouthwash with a high alcohol content is associated with an increased risk of oral and oropharyngeal cancer. However, recent research has found these studies to be flawed, pointing out that smokers and frequent drinkers (who are there- fore already at increased risk) are likely to use more mouthwash than people who neither smoke nor drink.
Do-It-Yourself Bleaching Dentists have been bleaching teeth in their offices for decades. This is a legitimate procedure that requires care to ensure that the patient is not injured by the caustic bleaching agent. The tooth whitening marketplace has four categories: (1) professionally applied, (2) dentist- prescribed for home-use, (3) over-the-counter (OTC) applied by patients, and (4) nondental options such as mall kiosks, salons, spas, and cruise ships. In addition, dentist-dispensed bleaching materials are sometimes used at home after dental-office bleaching to maintain or improve whitening results. The ADA Council on Therapeutics urges caution about bleaching that is not professionally supervised:
Tooth bleaching is one of the most conservative and cost- effective dental treatments to improve or enhance a person’s smile. However, tooth bleaching is not risk-free and only
limited long-term clinical data are available on the side ef- fects of tooth bleaching. Accordingly, tooth bleaching is best performed under professional supervision and following a pre-treatment dental examination and diagnosis. . . . Patients considering OTC products should have a dental examination, and should be reminded that they may unknow- ingly purchase products that may have little or no beneficial effect on the color of their teeth and may also have the potential to cause harm.30
Pain Relievers People with toothaches sometimes seek temporary relief by applying a nonprescription pain reliever to the teeth. These products usually contain clove oil, anesthetics, and aspirin. Clove oil is a powerful germicide. It is uncertain whether the relief it provides is due to a local anesthetic effect or its irritant activity. Anesthetics such as benzocaine and butane sulfate can provide minor relief from pain, if the decayed area of the tooth is exposed and accessible. Aspirin does not provide topical anesthesia. It should never be packed into a carious tooth or placed onto the adjacent gum because its acidic nature can traumatize a nerve ending and severely burn the mucous membrane of the mouth. Ibuprofen or naproxen, taken internally, can be effective against dental pain.
Dental restorations
The most common material used to restore decayed teeth is amalgam, a tightly-bonded mixture of mercury and an alloy of silver, tin, copper, and zinc. Tooth-colored plastic (composite) fillings can be used in front teeth or for small, visible back fillings. Amalgam fillings are less expensive, more durable, and easier to replace than composite fillings.31,32 If much tooth structure has been lost as the result of decay or an accident, then a cast restoration is used, preferably gold. A cemented restoration that covers only part of the tooth is called an inlay or onlay. Cast metal, porcelain, and composite plastic materials can be used for this purpose. When not enough tooth is present to hold an inlay, a crown is attached to the stump to restore the ap- pearance of the entire tooth above the gumline. Crowns are usually made of a combination of metal (preferably gold or palladium alloy) and porcelain. A front crown, sometimes called a cap, is sometimes solid porcelain. When teeth are missing, teeth on either side of the space can be crowned and artificial teeth (a bridge) can be permanently fastened to the crowns. A bridge cemented to adjacent teeth is called a fixed bridge. Fixed bridge- work is generally superior to removable bridgework, but there are situations where it cannot be used.
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The resin-bonded (Maryland) bridge, a type of fixed bridge developed by researchers at the University of Maryland, uses special materials that bond metal to tooth structures. This method enables the dentist to re- place missing teeth with a cemented restoration, without placing crowns on the adjacent teeth. It costs less than a conventional fixed bridge, but it is not as durable. “Drill-less Fillings” The Caridex is a trademarked device that uses a warm solution of sodium hydroxide, sodium chloride, sodium hypochlorite, and aminobutyric acid as its active ingredi- ent to soften decay so that it is easily scraped from the tooth with a metal instrument. This procedure is safe and allows some patients to be treated without an injection of anesthetic. However, most cavities are not sufficiently exposed, so drilling is still needed for the great major- ity of patients. The Caridex is very slow and therefore increases the cost of performing a filling. Bonding Bonding is a popular method of correcting cosmetic problems in patients with healthy gums and adequate tooth structure to which bonding material can be applied. Most dentists employ this procedure. Bonding is not an alternative to crowning. Crowns are needed if teeth are badly broken down or must anchor a bridge. To prepare a tooth for bonding, an acid solution is applied to increase adhesion. A liquid plastic is then painted on, and a paste made of plastic and finely ground quartz, glass, or silica gel is layered onto the tooth. Each layer is hardened in minutes either chemically or by shining a very bright light on the plastic. Finally the bonded surface is polished. Cosmetic results can also be achieved by bonding very thin plastic or porcelain veneers to the acid-etched tooth enamel. Bonding usually is painless and faster and cheaper than crowning. However, it is not permanent and may need to be repeated after several years because the bond- ing material wears away.
enDoDontiCs (root Canal theraPY) Teeth contain living, sensitive tissue commonly called the “nerve” but referred to by dentists as the pulp. In infections of the pulp caused by decay or accidents, the pulp can be removed and replaced with an inert mate- rial (gutta-percha). Endodontics is expensive (typically several hundred dollars per tooth) but should be painless. Teeth often need an artificial crown and post (to increase retention of the crown) following root canal therapy, but
millions of teeth have been saved through this therapy alone. Claims that endodontically treated teeth become a focus of infection or disease in other parts of the body have been refuted by meticulous research.33
Sargenti root canal therapy is a treatment that may save a tooth, but is much less predictable than standard endodontic treatment. It is performed with a paste that is easier and faster to place than gutta-percha. However, the paste contains paraformaldehyde, which, when it contacts water, forms formaldehyde (a preservative used in embalming fluid). The pressure needed to reach the tip of the root can force the paste into surrounding tissues where it can cause serious injury. The FDA has banned interstate marketing of Sargenti-type pastes, but some pharmacists compound them.34
Proponents of the Sargenti method have formed the American Endodontic Society, which has little or no standing within the scientific dental community. The recognized endodontic specialty group is the American Association of Endodontists.
orthoDontiCs
The goal of orthodontics is to improve the health and function of the mouth as well as the patient’s physical appearance. Twenty million adults and children receive orthodontic treatment annually; many others with cor- rectable misalignments of the teeth or jaws do not. The ADA recommends consultation with an orthodontist for children 4 to 7 years old if the family dentist suspects that the teeth are badly aligned. There is no age limit for orthodontic treatment, provided oral tissues are basically healthy. Before beginning treatment the orthodontist obtains facial measurements, x-ray films, and plaster casts to aid in diagnosis and treatment planning. Some ortho- dontists also use computer analysis. Teeth responsible for overcrowding may have to be extracted. Braces are prepared, cemented or bonded to the teeth, and wired together. Slight pressure is then maintained on the bands and wires so that the teeth are gradually brought into alignment. Some discomfort may be present during the first few days after braces are applied, but severe pain normally does not occur during orthodontic treatment. When proper occlusion has been achieved, the braces are removed and a retaining appliance is substituted. The average length of treatment is 18 to 24 months for children and adolescents. Adult treatment, which is more likely to involve removable appliances, generally takes longer. A full course of orthodontic treatment can cost $2000 to $5000 or more.
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Dentures
The preparation of dentures is a complex procedure best performed by a dentist with the help of a dental labora- tory technician. Poorly fitted dentures can cause serious problems, including difficulty in eating and speaking, disturbances of the temporomandibular joint (TMJ), and irreversible destruction of bone needed for denture support. Constant irritation from an ill-fitting denture, if continued over a long period, can cause open sores or inflammation. Full lower or upper dentures typically cost about $500 to $1000 each, but “high-end” models cost several thousand dollars. If plaque accumulates on dentures, it can cause mouth odors and lead to the formation of calculus that can irritate the soft tissue of the mouth. Therefore, dentures should be brushed daily with a commercially available denture cleaner. In time dentures may loosen and need rebuilding or repair. Adhesives, repair kits, and reliner kits are available to the public, but the do-it- yourself approach to denture repair is hazardous. If dentures do not fit tightly, a denture adhesive may help them remain in place. However, the American Col- lege of Prosthedontists35 states that (a) the vast majority of dentures that fit well do not require the regular use of denture adhesive, (b) because bones and gums may shrink over time, dentures may need to be relined to assure proper fit, (c) denture fit cannot be corrected by using increasing amounts of denture adhesive, (d) oozing out of of the adhesive when the denture is in place, signi- fies that the amount used is excessive, and (e) excessive use of zinc-containing adhesives can cause zinc toxicity.
Denturists Denturists are a relatively small number of technicians who provide dentures directly to the public and are seeking to be licensed independently from dentists. Denturism is illegal in most states. Denturists in Maine, Arizona, and Colorado can practice under the supervi- sion of a licensed dentist. Denturists are allowed to practice independently only in Oregon, Idaho, Montana, and Washington. Denturists assert that they can fit dentures as compe- tently as dentists and more cheaply. However, the ADA warns that denturists are not adequately trained to diag- nose cancers or other diseases within the mouth, to screen for underlying disease, or to recognize when structural problems of the mouth (such as unseen broken-off roots of teeth) can lead to injury if not corrected before the installation of dentures. No recent data are available to compare costs.
The ADA is strongly opposed to denturism and has encouraged dental societies to sponsor community pro- grams in which professionally acceptable dentures can be offered to financially disadvantaged individuals at a reduced cost. Programs of this type exist in most states. In addition, low-cost care may be available from dentists whose fees are comparable to those of denturists.
Dental iMPlants
Implants are artificial root substitutes that are placed within the jaw bone to anchor artificial teeth. They are usually made of titanium. The cost typically ranges from $800 to $1800 per implant for the surgical phase, plus the cost of the replacement teeth. Many successful implant systems are available. Most require a 3- to 6-month healing period during which the implant base (“fixture”) is hidden under the gum. The patient cannot have a temporary tooth that puts pressure on the implant fixture while chewing and must chew carefully. Newer implant systems allow the dentist to im- mediately put pressure on the implant fixture. This way a temporary tooth can be placed at the time of implant surgery and the patient can actually eat fairly normally, although heavy chewing is still not recommended. These types of implants are especially useful in the front of the mouth where appearance is particularly important. An important factor in the success of implants is to minimize chewing pressure on them for 3 to 6 months. This can be accomplished by hiding the base of the implant under the gum until the bone has healed suffi- ciently. Then surgery is performed to expose the implant for attachment of the artificial teeth. Consumers should carefully investigate the experience of any dentist they consult and request complete information about the type of implant and possible complications. An oral surgeon prosthodontist, or periodontist is likely to have the best skills for placing implants, but some general dentists have sufficient training to do the surgery properly.
Dental X-raY ProCeDures
X-ray films are a necessary part of modern dental practice. Usually they involve little radiation and are inexpensive, but so many are obtained that dental films are second only to chest examinations in frequency and overall cost. America’s annual bill for dental radiographs is more than $1 billion. Because any exposure to radiation involves some risk, the dental profession has worked hard to minimize exposure. This has been accomplished by (a) reducing
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exposure time by combining high-voltage equipment with high-speed film, (b) reducing the areas of exposure by using a device (collimator) that narrows the x-ray beam, (c) eliminating unnecessary repetition of x-ray films, and (d) using lead aprons to shield the rest of the body. Devices that save images as electronic files (digital x-rays) rather than on film expose the patient to about 10% of the radiation needed to create traditional x-ray images. Dentists typically obtain full-mouth radiographs of all the teeth at the beginning of the patient’s care and every 3 to 5 years thereafter. However, a history and clinical examination should be completed before deciding what type of dental radiography, if any, should be obtained. A full set normally consists of two to four bite-wing x-ray films, which show the areas between the teeth and the parts of the teeth that are outside of or just below the gums, and 14 periapical films, which reveal the deeper dental structures that include the tips of the roots of two or three teeth per film. For bite-wing and periapical views, the film is placed inside the patient’s mouth and the x-ray source is a sta- tionary machine. Panoramic views are obtained with a machine that swings the x-ray camera around the head, enabling all the teeth to be included in a single picture. This procedure is quicker and more comfortable for the patient because the film is positioned outside the patient’s mouth. Unfortunately, the resultant picture is not as detailed. Therefore bite-wing and periapical films are used to diagnose decay and periodontal disease, whereas panoramic films are appropriate for detecting diseases and infections in the jaw bones, orthodontic problems, and impactions (unerupted teeth). Children and adults generally do not need an x-ray examination each time they see a dentist if they are not at high risk for decay and show no other signs of dental disease. Young children rarely need x-rays because baby teeth usually are spaced so that all surfaces are visible to the naked eye. Bite-wing x-ray films are appropriate annually for most patients and may be obtained more frequently if rampant caries exists. On such a schedule the diagnostic benefit clearly outweighs the risk of ra- diation that is involved. What little risk exists is greatly reduced by the use of a lead apron. An expert panel has concluded that the adult guidelines need no alteration during pregnancy because the amount of radiation reach- ing the pelvis is insignificant.36
If recent films are available, it may not be necessary to obtain new ones. Dental radiographs often yield more information when compared with previous films. Thus, if consulting a new dentist, bring previous films or have them forwarded to the new dentist.
Questionable ProCeDures
Many teeth that are extracted because of decay could have been saved by modern dental treatment, with either a carefully performed large filling or root canal therapy followed by a crown. Dentists often overstate the dangers posed by third molars (“wisdom teeth”). Extraction is ap- propriate if they cause pain, form cysts, cause problems by pushing into other teeth, or are partially erupted and prone to cause gum infections. If none of these condi- tions exists, wisdom teeth should be left alone. Only 6% of wisdom teeth are diseased, and fewer than 1% cause trouble with the roots of adjacent teeth. Both competence and conflicts of interest play a role in inappropriate extractions. Some general dentists extract teeth that could be saved by filling them or refer- ring the patient to an endodontist for root canal therapy. The fact that insurance policies generally pay more for extractions than they do for fillings may be a factor. Oral surgeons also have conflicting interests when they realize that a patient has been inappropriately referred for an extraction. If they refer the patient for root canal therapy, they will not only lose the surgical fee but may also stop getting referrals from the general dentist. Dodes and Schissel37 believe that most oral surgeons faced with this situation perform the extractions.
Questionable Laser Use Some dentists use a laser device to “drill” cavities and advertise that this method is quicker, more precise, and less apt to require anesthesia than normal drilling. In 1997 the FDA approved the erbium:YAG laser for drill- ing teeth to remove tooth decay, to prepare cavities for fillings, and to roughen enamel to improve bonding of restorations. Lasers also have some proven uses in dental surgery. However, they cannot be used for drilling teeth with fillings already in place because the filling may heat up and damage the tooth, and, in many patients, a regular drill is still required to get through the enamel on molars. Lasers also should not be used to prepare crowns or inlays. In short, although lasers have legitimate uses in dentistry, they do not take the place of the more conventional tools that dentists use.38
Some dentists are using low-power lasers (like those in laser pointers), and some are using high-power radio waves to cut nerve endings to treat headaches. There is no scientific support for either treatment.
Questionable Cancer Screening Tests About 10% of U.S. dentists are using ViziLite Plus, a test that uses a tissue stain and fluorescent light to help den- tists spot abnormal changes of the mucous membranes
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inside the mouth and throat. The test, which costs about $65, is promoted as a way to help detect oral cancers in their early stages. However, it has not been proven more effective than inspection with ordinary (incandescent) light that is part of standard dental check-ups. In 2005, the ADA’s Council on Scientific Affairs rejected the man- ufacturer’s application for the ADA’s Seal of Acceptance, saying that the submitted data were “extremely weak.” Subsequent research has found no significant advantage over ordinary screening. Oral cancers are rare in young adults, but the manufacturer stated that everyone over 18 is at “increased” risk and everyone aged 40 or older is at high risk and should undergo annual screening.39 A 2008 literature review concluded that none of the adjunctive screening devices or techniques (ViziLite, Microlux DL, Orascoptic DK, VELscope, OralCDx, or toluidine blue staining) had been proven superior to standard dental inspection for general screening.40
Overuse of Air Abrasion Air abrasion systems consist of an air compressor and a delivery unit that holds an abrasive powder that is deliv- ered through a handpiece that is about the size of a dental drill. The technology is similar to a sandblaster with a fine tip. These machines blast aluminum oxide particles through a very small opening with high-pressure air and can rapidly abrade tooth enamel or dentin, which the dentist replaces with composite bonding material. Pro- ponents say air abrasion is a major advance in dentistry because “micro-dentistry” is now possible. Tiny holes can be cut to shallow depths without rotary cutting tools (drills or burrs). Actually, however, the smallest standard drills can equal the smallest hole cut by these machines and provide more precision. In skilled hands, air-abrasion equipment can be a useful adjunct to a dentist who wishes to do conservative dental procedures. The ability to cut small and shallow holes may make local anesthesia unnecessary. When used with improved composite resins (white plastic fillings), the technique of air abrasion can provide early treatment of simple tooth decay with small, conservative restorations. However, improper technique can cause excessive frictional heat, serious soft tissue damage, air embolism, and vaporization of mercury if the machine is used to remove amalgam fillings. To avoid most of these hazards, the machine manufacturer’s labeling re- quires use of a rubber barrier (dam), short cutting times, and careful control of the device. In addition the device should not be used to remove amalgam fillings. Baratz41 warns that because the device enables den- tists to cut and fill many teeth within a few minutes, some
unscrupulous dentists are doing unnecessary procedures. These dentists typically claim to be doing “early caries detection.” However, Baratz notes that even if early car- ies is present, it can often be arrested or reversed with proper oral hygiene or the use of a sealant.
Overuse of General Anesthesia Overuse of “conscious sedation” is another problem. Nearly all dental work can be done with local anesthesia, which entails almost no risk and is much less costly. Local anesthesia permits dentists to do complex pro- cedures slowly and carefully, without having to worry that the longer they take, the greater the risk. Some dentists routinely sedate patients with an intravenous medication such as diazepam or fentanyl. Dodes and Schissel state that dentists who do this feel pressured to work quickly and, as a result, may take shortcuts and do inferior work.37
“Bioesthetic Dentistry” Bioesthetic dentistry is a marketing term used by dentists who aim to provide “optimum dental health, beauty, and appearance” by correcting what they consider to be defects of the chewing system. It is one of several systems that postulate the existence of an ideal model that provides a blueprint for optimal dental care. Pro- ponents claim that their model enables them to observe the earliest stages of pathology—often before symp- toms occur—and to direct specialty care (orthodontics, orthognathic surgery, periodontics, prosthodontics, and restorative dentistry) to a common goal. Bioesthetic dentistry offers a very expensive way to improve appearance by extensive application of crowns and other restorations. A program that includes only minor reshaping and bonding would cost $5000 to $7000, but one in which all the teeth were crowned could cost over $40,000. Before-and-after pictures indicate that many patients improve their appearance. However, preparation for crowning requires removal of healthy tooth structure, and disturbing healthy, functional teeth may, in the long run, result in complications.42
Plastic Surgery Some dentists are taking 1- or 2-day courses in “facial esthetics” that include instruction in the use of botox, dermal fillers, lasers, and chemical peels intended to remove wrinkles, sculpture the lips, and enhance the cheeks. These procedures are not taught in dental school and may be outside the legal scope of dental care. Con- sumers who are considering them would be wiser to seek an appropriate medical specialist (see Chapter 18).
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Dental QuaCKerY
A significant number of dentists have gone overboard in espousing pseudoscientific theories, particularly in the area of nutrition. “Holistic” and “biological” dentists typically claim that disease can be prevented by main- taining “optimum” overall health or “wellness.”43 In the dental office this typically involves recommendations for expensive dietary supplements, amalgam removal, and/or a plastic bite appliance. Dodes1 has remarked that “wellness” is “something for which quacks can get paid when there is nothing wrong with the patient.”
Some practitioners use hair analysis, computerized dietary analysis, or a blood chemistry screening test as a basis for recommending supplements to “balance the body chemistry” of their patients. Hair analysis is not a reliable tool for measuring the body’s nutritional state (see Chapter 13). Computer analysis can be useful for determining the composition of a person’s diet and can be a legitimate tool for dietary counseling. Dentists re- ceive training in the nutritional aspects of dental health; however, few are qualified to perform general dietary counseling, and computerized “nutrient deficiency tests” are not legitimate (see Chapter 11). The blood chemistry
cal imbalances.” Page ran afoul of the Federal Trade Commission by marketing a mineral supplement with false claims that widespread mineral deficiencies were an underlying cause of goiter, heart trouble, tuberculosis, diabetes, anemia, high and low blood pressure, hardening of the arteries, rheumatism, neuritis, arthritis, kidney and bladder trouble, frequent colds, nervousness, constipation, acidosis, pyorrhea, overweight, underweight, cataracts, and cancer. Page also claimed that milk was “unnatural” and was the underlying cause of colds, sinus infections, colitis, and cancer. Hal A. Huggins, D.D.S., who describes himself as one of Page’s students, promoted “balancing body chemistry” so vigorously that in 1975 the ADA Council on Dental Research denounced the diet that he recom- mended. Huggins has also crusaded against amalgam fillings, marketed mineral products with false claims that they would help the body rid itself of mercury, and advised removal of endodontically treated teeth, which he claims can make people susceptible to arthritis, multiple sclerosis, amyotrophic lateral sclerosis, and other autoim- mune diseases. However, there is no objective evidence that either amalgam fillings or root canal therapy have any adverse effect on the immune system or any other part of the body. Another Price follower is George A. Meinig, D.D.S., whose book Root Canal Cover-up Exposed was published in 1994. The Price-Pottenger Nutrition Foundation of La Mesa, California, is the repository for many of Price’s manuscripts and photographs. It was founded in 1965 as the Weston Price Memorial Foundation and adopted its current name in 1972. Its newsletter, book catalog, and information service have promoted food faddism, megavitamin therapy, homeopathy, chelation therapy, and many other dubious practices.
Historical Perspective
The Legacy of Weston Price
Much of “holistic dentistry” is rooted in the activities of Weston A. Price, D.D.S. (1870–1948), a dentist who maintained that sugar causes not only tooth decay but physical, mental, moral, and social decay as well. Price made a whirlwind tour of primitive areas, examined the natives superficially, and jumped to simplistic conclu- sions. While extolling their health, he ignored their short life expectancy and high rates of infant mortality, endemic diseases, and malnutrition. While praising their diets for not producing cavities, he ignored the fact that malnour- ished people don’t usually get many cavities. Price knew that when primitive people were exposed to “modern” civilization they developed dental trouble and higher rates of various diseases, but he failed to realize why. Most were used to “feast or famine” eating. When large amounts of sweets were suddenly made available, they overindulged. Ignorant of the value of balancing their diets, they also ingested too much fatty and salty food. Their problems were not caused by eating “civilized” food but by abusing it. In addition to dietary excesses, the increased disease rates were due to (a) exposure to unfamiliar germs, to which they were not resistant, (b) the drastic change in their way of life as they gave up strenu- ous physical activities such as hunting, and (c) alcohol abuse. Price also performed poorly designed studies that led him to conclude that teeth treated with root canal therapy leaked bacteria or bacterial toxins into the body, causing arthritis and many other diseases. This “focal infection” theory led to needless extraction of millions of endodonti- cally treated teeth until well-designed studies, conducted during the 1930s, demonstrated that the theory was not valid. Melvin Page, D.D.S., one of Price’s disciples, coined the phrase “balancing body chemistry” and considered tooth decay an “outstanding example of systemic chemi-
Chapter Seven Dental Care 125
tests, usually obtained from a reputable laboratory, are legitimate but misinterpreted. Instead of accepting the laboratory’s range of “normal” values, misguided den- tists use a much narrower range and tell patients that anything outside that range means they are out of balance and need treatment. Disorders of the temporomandibular joint (TMJ, jaw joint) and facial muscles can cause facial pain and restrict opening of the mouth. Clicking alone does not mean that the jaw structure is defective. Allegations that TMJ problems can affect scoliosis, premenstrual syndrome, or sexual problems are not supported by scientific evidence. Scientific studies show that 80% to 90% of patients with TMJ pain will get better within three months if treated with nonprescription analgesics, moist heat, and exercises. Dodes1 warns that correction of a “bad bite” can involve irreversible treatments such as grinding down the teeth, building them up with dental restorations, and placing a plastic appliance between the teeth to realign the jaw. These devices, called mandibular orthopedic repositioning appliances (MORAs), typically cover only some of the teeth and are worn continuously for many months or even years. When worn too much, MORAs can cause the patient’s teeth and jaws to move so far out of proper position that orthodontics or facial reconstruc- tive surgery is needed to correct the deformity. Some TMJ patients can benefit from conservative use of oral appliances that do not cause irreversible changes. Klasser and Greene44 note that rather than try- ing to establish new horizontal or vertical jaw relation- ships, these appliances should be viewed as “crutches” that are analogous to back braces because they provide symptomatic relief while patients are recovering. MORAs and other custom-fitted devices are also claimed to enhance athletic performance by realigning the jaw joints. Those marketed as “performance mouth- guards” usually cost at least $495 plus the cost of dental services. Advocates claim that the alleged benefits have a hormonal basis. Although mouthguards can protect against certain types of athletic injury, there is no logical reason to believe they will initiate hormonal changes, lessen “stress” throughout the body, or benefit athletic performance or general health. Leading marketers cite various studies, but these are insufficient to back their claims.45 Proponents of “cranial osteopathy,” “craniosacral therapy,” “cranial therapy,” and similar methods claim that the skull bones can be manipulated to relieve pain (especially TMJ pain) and remedy many other ailments. They also claim that a rhythm exists in the flow of the
fluid that surrounds the brain and spinal cord and that diseases can be diagnosed by detecting aberrations in this rhythm and corrected by manipulating the skull. Proponents include dentists, physical therapists, os- teopaths, and chiropractors. The theory underlying craniosacral therapy is erroneous because the bones of the adult skull are fused to each other, and cerebrospinal fluid does not have a palpable rhythm. In a test, three physical therapists who examined the same 12 patients diagnosed significantly different “craniosacral rates.”46
Auriculotherapy is a variation of acupuncture based on the notion that the body and organs are represented on the surface of the ear. Proponents claim it is effective against facial pain and ailments throughout the body. Its practitioners twirl needles or administer small electrical currents at points on the ear that supposedly represent diseased organs. Courses on auriculotherapy are popular among “holistic” dentists. Complications from unsterile and broken needles have been reported. Some dentists claim to specialize in the treatment of bad breath. Dodes and Schissel37 have warned that such dentists have no special expertise and are primarily interested in increasing their income by selling unproven products. Some dentists assert that facial pain, heart disease, arthritis, chronic fatigue, and various other problems are caused by “cavitations” within the jaw bones that are not detectable on x-ray examination. Advocates call this condition “cavitational osteopathosis” or “neuralgia- inducing cavitational osteonecrosis (NICO)” and claim they can cure the patient by locating and scraping out the affected tissues. They may also remove all root-canal- treated teeth and most of the vital teeth close to the area where they say a problem exists. There is no scientific evidence to support this assertion or the diagnostic and treatment methods based on it.47 Proponents have formed the American Academy of Biological Dentistry.
The Mercury Scare Mercury is a component of the amalgam used for “silver” fillings. The other major ingredients are silver, tin, cop- per, and zinc. When mixed, these elements bond to form a strong, stable substance. Very sensitive instruments can detect billionths of a gram of mercury vapor in the mouth of a person with amalgam fillings. Some dentists claim that the mercury in amalgam fillings is toxic and causes a wide range of problems, including multiple sclerosis, arthritis, headaches, Par- kinson’s disease, and emotional stress. They recommend that amalgam fillings be replaced with either gold or plastic ones and that vitamin supplements be taken to
Part Two Health-Care Approaches126
prevent trouble during the process. Some dentists use an industrial mercury detector to indicate that “toxic” amounts of mercury are being released. To use the de- vice, the dentist asks the patient to chew vigorously for 10 minutes, which may cause tiny amounts of mercury to be released from the fillings. Although this exposure lasts just a few seconds and most of the mercury is exhaled rather than absorbed by the body, the machine gives a readout that the dentist misinterprets as dangerous.50
The proper way to determine mercury exposure is to measure blood and urine levels, which indicate how much has been absorbed by the body. Scientific testing has shown that the amount of mercury absorbed from fillings is only a small fraction of the average daily intake from food and is far below the level that exerts any adverse health effect.51,52 Thus there is no logical reason for consumers to be concerned about or tested for “amalgam toxicity.” In 1992 an extensive review by the U.S. Public Health Service53 concluded that it was inappropriate to recommend restricting the use of dental amalgam. The ADA considers the unnecessary removal of amalgam fillings “improper and unethical.”54 The National Council Against Health Fraud recommended that dental licens- ing boards classify as unprofessional any advice that amalgam fillings are dangerous and should therefore be avoided or removed. The Council also recommends banning any advertising of “mercury-free dentistry” which implies the same risk.55
The leading advocate of “amalgam toxicity” has been Hal A. Huggins, D.D.S., of Colorado Springs, Colorado (see Figure 7-4). Huggins’s dental license was revoked in 1996. During the revocation proceedings the administrative law judge concluded (a) Huggins had di- agnosed “mercury toxicity” in all patients who consulted him in his office, even some without amalgam fillings; (b) he had also recommended extraction of all teeth that had had root canal therapy; and (c) Huggins’s treatments were “a sham, illusory and without scientific basis.”56
Huggins also devised a blood test that supposedly can determine which materials are safest for replacing the amalgam fillings that are removed. Baratz warns that this test is worthless.57
Choosing a Dentist
Good dentists take a personal interest in patients and their health. They are prevention-oriented but not fad- dists. They use x-ray films and probably suggest a full- mouth study unless suitable films are available from the patient’s previous dentists. According to Dodes:
Historical Perspective
Toxic Television In 1990 CBS-TV’s “60 Minutes” aired a half-hour program called “Poison in Your Mouth,” which sug- gested that amalgam fillings were dangerous. The most powerful segment featured a woman who said that her multiple sclerosis symptoms had disappeared overnight after her fillings were removed. The program failed to mention that multiple sclerosis typically has ups and downs. Nor did it reveal that the removal process temporarily raises the body’s mercury load and could not possibly cause an overnight cure.48 The broadcast induced many viewers to seek replacement of their fillings with other materials. Consumer Reports responded with an article that concluded: “Given their solid track record and a risk that’s still conjecture, amalgam fillings are still your best bet.”49 A few months later, a reader wrote:
My mother, who was diagnosed with Lou Geh- rig’s disease more than two years ago, had her mercury fillings removed immediately after the show aired. After she had spent $10,000 and endured more than 18 hours of dental work so painful she once fainted in the waiting room, her condition did not improve. The pain was out- weighed only by the monumental disappointment she and the whole family experienced as we lived through one more false hope.
Figure 7-4. Misleading flyer from Hal A. Huggins, D.D.S., the leading anti-amalgamist. Whereas the mercury in thermometers is pure, the mercury in amalgam fillings is chemically bound and is not released into the body in significant amounts. Moreover, no toxic effects have been reported in cases where a thermometer has broken while someone’s temperature is being taken.
Chapter Seven Dental Care 127
Dental work can last a lifetime but, unfortunately, this is not always the case. In a good dentist’s office the vast majority of work lasts a very long time, while in the office of Dr. Poorwork the majority of dental work falls out or decays out in a few years. The price of dental work is not the best way to judge quality; rather, pay attention to the time the dentist takes to do the work. High-quality dentistry cannot be done assembly-line style; it takes time and meticulous attention to detail.
Dental evaluations should include looking for signs of tooth decay, gum disease, cancers, and precancerous areas (leukoplakia). A thorough examination includes inspection of the teeth, gums, tongue, lips, inside of the cheek, palate, and the skin of the face and neck, plus feeling the neck for abnormal lymph nodes and enlarge- ment of the thyroid gland. In adults a periodontal probe should be inserted between the gums and teeth to detect abnormally large crevices. Good dentists also chart their findings in detail. The frequency of maintenance care (including calculus removal and x-ray examinations) should be based on an assessment of the frequency of cavity formation, the rate of calculus formation, the condition of the gums, and any other special problem. Once current treatment has been completed, the patient should be placed on a recall schedule and notified when checkups are due.
Suggestions for Choosing a Dentist59
• Friends, neighbors, or co-workers may be asked to recommend dentists with whom they are pleased.
• If there is a dental school in the area, faculty members may be able to suggest practitioners in the commu- nity.
• The dental department of a nearby hospital with an accredited dental service should be able to offer suggestions.
• The local dental society or an ADA Directory, copies of which can be found in dental school libraries and many public libraries, may be helpful.
• Your family physician may be able to recommend a dentist. However, the best professionals to query are usually periodontists whose day-to-day practice enables them to evaluate the work of their general dentist colleagues.
• Visiting a prospective dentist’s office before making an appointment may reveal whether it is clean and run efficiently.
• Avoid dentists who purport to be practicing “ho- listic” or “biological” dentistry, who sell vitamins, use acupuncture or “electro-diagnosis,” or say that fluoridation or amalgam fillings are dangerous.
√ Consumer Tip
Friedman58 warns that flamboyant advertising is likely to signify an emphasis on mass production rather than quality care. When the fees charged per service are low, the number of services performed may be greater than needed, resulting in higher overall cost. He also states that dentists who advertise “twilight sleep,” cos- metic dentistry, and one-visit comprehensive treatment are seldom interested in long-term maintenance care that does not generate high income. He recommends avoid- ing dentists who use intravenous sedation; recommend automatic amalgam replacement; or “specialize” in cosmetic dentistry or in treating headaches, backaches, myofacial pain, or TMJ problems. It makes sense to become acquainted with a family dentist before an emergency arises. You should not be embarrassed to ask about fees and payment plans. Most dentists prefer patients to initiate discussion of fees because patients know more about their own financial situation. Consumers Research60 offered these questions for judging a dentist’s skills after you have received treatment:
• How does your bite feel? • Is any of the dental work irritating your gum? • Does the treated tooth look like a tooth? • Does dental floss or your tongue catch on the tooth? • Did the dentist take time to polish your fillings? • Do you feel pain when drinking hot or cold liquids? • Was any debris left in your mouth after treatment? • Does the dentist use a water spray to cool your teeth while
drilling?
In 1996, a reporter on assignment for Reader’s Digest visited 50 dentists in 28 states and found that their fees, examinations, and recommendations varied widely. The visits cost from $20 to $141. The reporter brought along his own x-ray films and told the dentists he had ample insurance coverage. Only 21 of the 50 dentists conducted cancer screening as recommended by the ADA, and only 14 did the recommended periodontal screening. Before embarking on the study, the reporter was checked by Dr. Dodes and three other dentists who agreed that he had only one immediate problem (one molar needed filling or a crown) and that work on another tooth might be advisable. Only 12 of the dentists agreed with this appraisal, and 15 failed to note a problem with the molar. One dentist recommended crowning all of the reporter’s teeth, at a cost of $13,440. Other estimates ranged from $500 to $29,850. The reporter also visited a dental school clinic where a student and a depart- ment chairman independently recommended capping both teeth, which would cost $460. When asked how
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consumers can protect themselves from overtreatment and overcharging, an ADA adviser suggested seeking a second or third opinion so they can have comfort with the practitioner’s recommendations, particularly if much work is proposed. The reporter replied: “I got 50 opin- ions, and I am not comforted.”63
In 1997, ABC-TV’s “Prime Time Live” conducted a similar investigation in which, after evaluation by an expert panel, two patients with completely healthy mouths were examined by six dentists. One patient was given estimates ranging from $645 to $2563. The other received estimates ranging from $2135 to $7960. No program was broadcast, but the figures were made public by a review panel member.64
suMMarY
A combination of nutrition, oral hygiene, and profes- sional care will enable most people to maintain their teeth in good condition throughout their life. Adequate amounts of fluoride during childhood will help make teeth resistant to decay. The most efficient way to ac- complish this is through water fluoridation and the use of fluoridated toothpaste. Thorough brushing and floss- ing of the teeth can prevent tooth decay and periodontal disease. Professional care may include administration of sealants, removal of calculus (tartar), restoration of decayed or missing teeth, and cosmetic measures. Most dentists provide competent care, but consumers should be alert to the signs of overselling and dental quackery. Dentists who practice “holistic,” “biological,” or “bio- esthetic” dentistry should be avoided.
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Personal Glimpse
Egregious Patient Abuse61
A class-action suit has been filed against FORBA Holdings, LLC, several related companies, and as-yet- unnamed dentists who have operated “Small Smiles” and related clinics in 23 states. FORBA operates the largest chain of dental clinics that serve children on Medicaid. The complaint charges:
• The defendants conspired to perform unnecessary procedures and used unnecessary physical restraints upon children in order to fraudulently obtain extra compensation.
• At least 300,000 children may have been treated improperly.
• Medicaid-eligible children would have an appoint- ment for a routine check-up and cleaning at the defendants’ clinics. The dentist would evaluate the patient’s mouth after the cleaning and x-ray films were obtained.
• The x-rays were often unnecessary, taken incorrectly, taken by employees not licensed to operate the x-ray machine, and/or unreadable or even blank.
• Parents/guardians were then brought to a consul- tation room where they were told that their child needed extensive work, including pulpotomies and steel crowns
• Parents were pressured to sign consent forms im- mediately so that the extensive procedures could be done the same day as the initial consultation. Defen- dants thought that if the patients left the building, they might obtain a second opinion about the need for additional procedures and might not return.
• FORBA also encouraged its clinics to use a “papoose board” to immobilize the children, regardless of whether or not restraint was necessary.
• Parents were not permitted to observe their children’s treatment.
• FORBA’s clinics were ordered to clean the children as much as possible before sending them back to their parents, including washing their clothes so that the parents would not find out that the children had urinated or vomited on themselves.
The FORBA story may be the most egregious patient- abuse scandal ever reported. So far, FORBA has agreed to pay $36.8 million to settle three government actions that alleged fraudulent Medicaid billings. The unneces- sary work included multiple stainless steel caps and as many as 16 pulpotomies (“baby root canals”) during one sitting. ABC-TV’s “20/20”62 has vividly demon- strated the abuse to which many of the children were subjected. At least 15 dentists who worked for FORBA have been disciplined, but many more should be.
Chapter Seven Dental Care 129
It’s Your Decision
1. Your gums have started to bleed when you brush your teeth. Which of the following actions should you take?
Reason ___ Stop brushing your teeth __________ ___ Use a new toothbrush __________ ___ Try a different toothpaste __________ ___ Try using a mouthwash __________ ___ Floss your teeth daily __________ ___ Use a dental stimulant __________ ___ Take a vitamin supplement __________
2. A dentist has suggested that all your amalgam
fillings should be replaced with other fillings because of health dangers from the mercury in your fillings. Should you follow this advice or look for another dentist? Why?
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51. Mackert JR. Dental amalgam and mercury. Journal of the American Dental Association 122:54-61, 1991.
52. Mackert JR Jr, Berglund A. Mercury exposure from dental amalgam fillings: Absorbed dose and the potential for adverse health effects. Critical Review of Oral Biology and Medicine 8:410-436, 1997.
53. Benson JS and others. Dental Amalgam: A Scientific Review and Recommended Public Health Strategy for Research, Educa- tion and Regulation. Washington, D.C., 1993, US Public Health Service.
54. Berry JH. Questionable care: What can be done about den- tal quackery? Journal of the American Dental Association 115:679–685, 1987.
55. NCAHF position paper on amalgam fillings. National Council Against Health Fraud Web site, 2002.
56. Barrett S, Baratz RS. How to choose a dentist. Dental Watch Web site, May 8, 2010.
57. Connick N. Initial decision in the matter of the disciplinary proceedings regarding the license to practice dentistry in the State of Colorado of Hal A. Huggins, D.D.S., Feb 29, 1996.
58. Friedman JW and others. Complete Guide to Dental Health: How to Avoid Being Overcharged and Overtreated. New York, 1991, Consumer Reports Books.
59. Baratz RS. “Serum compatibility” testing. Quackwatch Web site, Dec 21, 1999.
60. How to choose a dentist. Consumers Research, March 1997, pp 20–24.
61. Barrett S. Massive dental fraud uncovered. Dental Watch Web site, Aug 23, 2011.
62. The littlest patients. ABC-TV, March 9, 2009. 63. Ecenbarger W. How honest are dentists? Reader’s Digest, Feb
1997, pp 50-56. 64. Dodes J. Coverage questioned (letter to the editor). ADA News,
Sept 15, 1997.
Chapter Eight
There cannot be two kinds of medicine—conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted. But assertions, speculation, and testimonials do not substitute for evidence.
Marcia angell, M.D. JeroMe Kassirer, M.D.1
The more mysterious, ancient, traditional, spiritual and holistic an explanation is, the more pow- erful and attractive it seems to be. The fact that vitalism is unscientific and posits the existence of an ethereal force beyond the powers of science to detect, may in itself be attractive to those who can’t live with the realities of the material world, are unable to deal with a negative or uncertain diagnosis or prognosis, those who fear science and to those who are unable to understand it.
Peter H. canter, PH.D.2
The reason we should defer to experts is not that the experts know everything. Of course they don’t. It’s just that they know more than non-experts do. It’s not that science has all the answers. It doesn’t. It’s just that astrologers, shamans, and natural healers have none of them.
DaviD FruM3
© harley schwadron
“Tell them about your psoriasis, Betty. Maybe they can cure it.”
The “CAM” MoveMenT
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• “Complementary and alternative medicine” is an ambiguous marketing term rather than a sharply defined set of practices. Thus general statements about its popularity or effectiveness should be interpreted very cautiously.
• The vast majority of methods referred to as “alternative” lack a scientifically plausible rationale.
• Calling a method “complementary” does not mean that adding it to an effective method will improve the outcome.
• Many proponents of unscientific “alternatives” hold sincere beliefs that their methods are effective or worth trying.
• Under the rules of science, the burden of proof falls on those who make the claims. Few “CAM” proponents test their claims or even keep track of their results, and many don’t feel that the rules of science are applicable to them.
• “Alternative” proponents are campaigning to abolish consumer protection laws that require products and services to be proven effective before they are marketed.
Keep These poinTs in Mind As You sTudY This ChApTer
Key Concepts
The phrase “complementary and alternative medicine” (“CAM”) is a euphemistic label for practices most of which are unsubstantiated and
lack a scientifically plausible rationale. “CAM” is also a social movement that involves businesses, media outlets, academic institutions, health professionals, gov- ernment agencies, self-proclaimed healers, celebrities, authors, bloggers, spiritualists, legislators, and crusad- ing consumer groups. The National Institutes of Health Center for Complementary and Alternative Medicine (NCCAM)4 defines “CAM” as:
A group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Complementary medicine is used to- gether with conventional medicine, and alternative medicine is used in place of conventional medicine.
The above statement implies that “CAM” methods actually complement or serve as sensible alternatives to standard methods. However, the “CAM” marketplace is dominated by products and services that do neither. The dictionary definition of the noun “alternative” is a choice between mutually exclusive possibilities. Until the late 1980s, in standard medical usage, it referred to choices among effective treatments. In some cases they were equally effective (for example, the use of radiation or surgery for certain cancers); in others the expected outcome differed, but there were reasonable tradeoffs between risks and benefits. Today, however, the word “alternative” is applied to a multitude of approaches that would be more accurately classified as irrational, ineffective, or quack. Dictionaries define the adjective “complementary” as completing or combining to enhance or emphasize each other’s qualities. Thus, referring to something as “complementary medicine” implies that it completes
or enhances what standard medicine does not do by itself. However, just because something is called complementary does not mean it is effective. If a treatment doesn’t add to the patient’s outcome, it doesn’t complement; it just adds to the cost.5 Despite their misleading nature, the terms “alter- native,” “complementary,” and “CAM” have become institutionalized in our culture. This book uses quotation marks to remind readers that these terms are inherently misleading. Although many of the source materials and opinions cited in this chapter originated long ago, they remain relevant to the current marketplace. Enough is known about many “CAM” practices to evaluate their worth. Some may be appropriately used as part of the art of patient care or as self-care. Relaxation techniques and massage are examples. But practices linked to belief systems that reject science itself have no place in responsible medicine. A complete listing of “CAM” methods would be a monumental task, if not an impossible one. This chapter focuses on methods that have been widely publicized. Other chapters cover additional practices related to mental health, dental care, chiropractic, nutrition, weight control, cardiovascular disease, cancer, and aging.
ClAssifiCATion
The NCCAM classifies “CAM therapies” into five “do- mains”: (1) whole medical systems, (2) mind-body medi- cine, (3) biologically based practices that use natural substances, (4) manipulative and body-based practices, and (5) energy medicine, which includes unusual uses of measurable electromagnetic fields as well as methods intended to influence “biofields,” the existence of which have not been demonstrated.4
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Whether something should be considered “alterna- tive” depends not only on the method itself but also on how it is used and what claims are made for it. Spinal ma- nipulation, for example, may be useful in properly selected cases of low-back pain. But manipulating the spine once a month for “preventive maintenance” or to promote general health—as many chiropractors recom- mend—has no plausible rationale. Relaxation techniques have a limited but acceptable role in the treatment of anxiety states. But meditation for the purpose of “balanc- ing” one’s “life energy” is another matter. Consideration of herbal products is even more complicated (see Chap- ter 11). The vast number of available “CAM” products include some that have proven usefulness, some that are toxic, and many that have no plausible medical use. Critics are concerned that “alternative” methods
are promoted as equally useful or better than standard methods even though they are not. It makes more sense to classify alternatives as genuine, experimental, or questionable.6 Under this system, genuine alternatives are comparable methods that have met science-based criteria for safety and effectiveness; experimental alter- natives are unproven but have a plausible rationale and are undergoing responsible investigation; and question- able “alternatives” are groundless and lack a scientifi- cally plausible rationale. Classifying proven therapies as “alternative” is advantageous to proponents who suggest that if some work, the rest deserve equal consideration and respect. Practitioners of “integrative” medicine claim to syn- thesize standard and alternative methods, using the best of both. However, no published data indicate the quality
Historical Perspective
Folk (Traditional) Medicine
Webster’s New Collegiate Dictionary defines folk medi- cine as “traditional medicine as practiced non-profession- ally by people isolated from modern medical services and involving especially the use of vegetable [plant-derived] remedies on an empirical basis.” Traditional medicine is largely primitive medicine, which assumes that super- natural forces are responsible for both the cause and cure of disease. Even herbal remedies may be said to harbor either good or evil spirits, so that believers can explain failures or successes in supernatural terms. Curanderas, popular among Mexican-Americans, are regarded as specialists in the folk medicine of their people. The conditions they treat include mal ojo (“evil eye”), mal aire (“bad air” due to evil spirits or other forces believed to inhabit the air), bilis (anger), susto (fright), and diseases of “hot and cold imbalance.” Their ministrations include prayers, religious objects, herbs, and dietary measures. Powwow, centered in rural Pennsylvania, combines prayer and laying on of hands. They may touch an af- flicted part lightly, rub the surrounding area vigorously, or pass their hands over the entire body while praying either quietly or aloud. Some practitioners sell charms, spells, potions, and other paraphernalia. Some prescribe and sell herbs and teas. Root doctors, found mainly in southeastern states, are consulted by people who believe they have been “hexed” or have had unduly bad luck. The “doctor” listens to their story and either prepares a token, charm, powder, or other special object (“root”) that can help them fulfill their wishes or undo the hex. Voodoo, a religion indigenous to Haiti, is also prac- ticed in southern Louisiana and elsewhere in the United
States where Haitians have migrated. Derived from ances- tor worship, it invokes spirits to explain and influence the course of events. It includes an elaborate system of folk medical practices. Voodoo “queens” and “doctors” also sell charms, magical powders, and amulets promised to help cure illness and grant other desires. Folk medicine, even when known to be toxic, is not generally considered quackery so long as it is not done for financial gain. Thus self-treatment, family home treat- ment, neighborly medical advice, and the noncommercial activities of folk healers should not be labeled as quackery. State laws against practicing medicine without a license are rarely enforced against folk healers. However, folk medicine and quackery are closely connected because folk medicine often provides a basis for commercial exploitation. For example, herbs long gath- ered for personal use have been packaged and promoted by modern entrepreneurs, and practitioners who once served their neighbors voluntarily or for gratuities may market themselves outside their traditional communities. Folk beliefs may influence the ability or willingness of a patient to cooperate with or respond to scientific treatment. Some science-based programs have enlisted folk healers to help gain the trust of people who have little knowledge of medical care. De Smet7 has noted that some folk remedies have therapeutic benefits, some may provide psychosocial benefits, and others (such as azarcón powder, rattlesnake meat, and certain herbal teas) can produce serious adverse reactions. Young8 has noted that scientific medicine discards inferior therapies as science advances, but folk medicine and quackery continue to use these as long as a demand persists.
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of such care or the extent to which they burden patients with medically useless methods. Typically these practi- tioners employ a “heads-I-win, tails-you-lose” strategy in which they claim credit for any improvement experi- enced by the patient and blame standard treatments for any negative effects. This may undermine the patient’s confidence in standard care, reducing compliance or causing the patient to abandon it altogether.9 The “integrated” concept has been further criticized by Arnold Relman, M.D., former editor of The New England Journal of Medicine10:
There are not two kinds of medicine, one conventional and the other unconventional, that can be practiced jointly in a new kind of “integrative medicine.” Nor . . . are there two kinds of thinking, or two ways to find out which treatments work and which do not. In the best kind of medical practice, all proposed treatments must be tested objectively. In the end, there will only be treatments that pass that test and those that do not, those that are proven worthwhile and those that are not,
populAriTY
Prevalence reports depend on the modalities that are included and the methods used to collect the data. Al- though this limits their usefulness in discerning trends, taken together, they indicate that many of the methods described in this chapter are widely used. A 1993 report by David Eisenberg, M.D.11 claimed that one out of three Americans was using unconven- tional care. However, this figure was inflated by counting exercise, relaxation, self-help groups, and commercial weight-loss clinics as “alternative,” even though they involve practices that are medically accepted.12 A 1999 report of practitioner use concluded that 6.5% of Americans used both unconventional and conventional practitioners, 1.8% used only unconventional services, 59.5% used only conventional care, and 32.2% used neither.13 The most comprehensive report on “CAM” use among Americans was based on data on more than 23,000 adults and 9000 children gathered during the 2007 National Health Interview Survey (NHIS). The report noted that the methods most commonly used by adults age 18 or older during the previous 12 months were nonvitamin, nonmineral natural products (17.7%), deep breathing exercises (12.7%), meditation (9.4%), chiropractic or osteopathic manipulation (7.5%), mas- sage (8.3%), and yoga (6.1%). The most commonly used modalities by children were nonvitamin, nonmineral natural products (3.9%), chiropractic or osteopathic manipulation (2.8%), deep breathing exercises (2.2%), yoga (2.1%), and homeopathic treatment (1.3%). Prayer-
related practices, which are more common than any of these, were not included in this survey.14
Another NHIS report15 estimated that in 2007, adults in the United States spent $33.9 billion out of pocket on visits to CAM practitioners and purchases of CAM prod- ucts, classes, and materials and about 38 million adults made an estimated 354 million visits to the practitioners. Hyman16 has noted that popularity is not a reliable yardstick of effectiveness:
Every system—be it based on the position of the stars, the pat- tern of lines in the hand, the shape of the face or skull, the fall of the cards or the dice, the accidents of nature, or the intuitions of a “psychic”—claims its quota of satisfied customers.
It is often suggested that people seek “alternatives” because doctors are brusque, and that if doctors were more attentive, their patients would not look elsewhere. It is true that doctors sometimes pay insufficient atten- tion to the emotional needs of their patients. But some people’s needs exceed what scientific health care can provide. A Canadian study of children attending an outpatient clinic found that word of mouth, fear of drug side effects, and persistence of a medical problem were more significant than dissatisfaction with conventional medicine in influencing their parents’ decision to seek “alternative” care.17 A New Zealand study of 148 cancer patients using “alternative” approaches found that most were satisfied with conventional medicine and used alternative therapy only as a supplement.18 Furnham and Smith19 have suggested that “CAM” users may fall into three groups: “principalists,” who believe in “CAM,” people who are primarily frustrated with mainstream care, and “opportunists” who shop around. A study based on NHIS data found that among those who used only “alternative medicine” for treat- ment purposes, about half said they “thought it would be interesting to try,” about 20% each said they believed that standard treatments would not work, and about 20% said they were too expensive.20 Misleading publicity also plays an important role in fostering popularity. Few media outlets place “alterna- tive” methods in proper perspective; most reports feature the claims of proponents and testimonials from satisfied customers. The National Center for Homeopathy, which rates reports that mention homeopathy, has concluded that since 1999, only 12% of more than 1000 mentions of homeopathy were negative. Critical analyses of acupuncture, ayurveda, chelation therapy, chiropractic, macrobiotics, and naturopathy are even scarcer. Figure 8-1 shows an ad that promotes a “CAM” newsletter by exaggerating problems within our mainstream health care system.
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CoMMon TheMes
Public interest in “alternative medicine” is part of a general societal trend toward rejection of science as a method of determining truths.21 In line with this phi- losophy, “alternative” proponents assert that scientific medicine is but one of a vast array of health-care options worth considering. Ernst22 has countered that “Anatomy, physiology, and pathology are not ‘Western medical systems.’ They are generalizable truths that apply to all humans.”
Vitalism Many “alternative” approaches are rooted in vitalism, the concept that bodily functions are due to a vital principle or “life force” distinct from the physical forces explain- able by the laws of physics and chemistry. Nonscientific health systems based on this philosophy maintain that diseases should be treated by “stimulating the body’s ability to heal itself” rather than by “treating symptoms.” Homeopaths, for example, claim that illness is due to a disturbance of the body’s “vital force,” which they can correct with special remedies, whereas acupunctur- ists claim that disease is due to imbalance in the flow
of “life energy” (chi or qi), which they can balance by twirling needles in the skin. Many chiropractors claim to assist the body’s “Innate Intelligence” by adjusting the patient’s spine (see Chapter 9). Naturopaths speak of “Vis Medicatrix Naturae.” Ayurvedic physicians refer to prana. And so on. The “energies” postulated by vitalists are not objectively measurable. Although vitalists often pretend to be scientific, they really reject the scientific method with its basic assumptions of material reality, mechanisms of cause and effect, and testability of hypotheses. They regard personal experience, subjective judgment, and emotional satisfaction as preferable to objectivity and unbiased evidence. Many “CAM” advocates claim to use an individu- alized approach that “treats the patient rather than the disease.” This enables them to claim effectiveness even though the patient’s symptoms do not improve. Cor- recting “imbalances” and “strengthening” the immune system are common claims of this type.
“Quantum Healing” Quantum mechanics is an extremely complex branch of physics that explains how objects at the subatomic level behave differently than objects in our ordinary experience. Proponents of “mind-body medicine” and similar endeavors claim that quantum physics supports the belief that health can be improved by manipulating forces that cannot be detected with current scientific instrumentation. They also assert that the human mind controls reality and that the universe is a connected whole that cannot be understood by the usual reduction to measurable parts. In November 2011, a Google search for “quantum healing” yielded 2,240,000 Web pages. In Ageless Body, Timeless Mind: The Quantum Alternative to Growing Old, Deepak Chopra, M.D.,23 says that our cells subtly and constantly adjust to our perception of time and that transcendental meditation can slow or reverse the aging process by “taking the mind to a reality where time does not have such a hold.” A #1 best-selling book, The Secret,24 carries wishful thinking even further by claiming that people who think good thoughts will attract like thoughts and have good things come to them. The author claims that this “law of at- traction” has enabled people with cancer, heart disease and many other problems to recover. Physicist Victor Stenger25 has noted that the popu- lar versions of quantum mechanics have nothing to do with the real thing. He states: (a) quantum fields are theoretical objects and do not describe an “aether” or other continuous medium that permeates all space; (b) the brain is wired to the body, but not to other bodies,
figure 8-1. Portion of an ad for Health & Healing, a newsletter that advocates “alternative” methods. Most statements in the ad are either false or misleading.
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(c) no evidence has ever been found for any unique fields or radiation associated with living organisms; and (d) nothing in quantum theory requires the existence of undetectable (nonmaterial) forces.
“Holistic Medicine” The term “holistic” (also spelled “wholistic”) is used in both scientific and nonscientific circles. However, considerable confusion surrounds its use. Scientific practitioners regard holistic medicine as treatment of the “whole patient,” with due attention to emotional factors as well as the patient’s lifestyle. But most who label their approach holistic use methods that are nonscientific, nar- row in focus, and less likely to be individualized to fit their patients. (Whereas scientific practitioners obtain a thorough history to understand the patient’s total clinical picture, ayurvedic practitioners focus on “body-types,” chiropractors tend to focus on the spine, and so on.) Stalker and Glymour,26 who have studied the holistic movement closely, consider it “a pablum of common sense and nonsense offered by cranks and quacks and failed pedants who share an attachment to magic and an animosity to reason.” Some people espouse the holistic approach as an important modern development in the health-care field. Critics reply that good physicians have always consid- ered their patients as whole beings and that the term holistic is a dangerous banner under which practitioners of nonscientific methods rally. Many chiropractors, for example, have organized “holistic” or “wellness” centers that offer “natural” treatments and “preventive” services, but the recommended methods typically include unnec- essary vitamin supplements and spinal adjustments for everyone. In contrast, science-based wellness and health educa- tion programs emphasize (a) making rational lifestyle choices such as healthful eating and smoking cessation, (b) improving quality of life beyond simply avoiding disease development, (c) commitment to ethical values, (d) physical fitness, (e) critical thinking, (f) skills for coping with life’s challenges, and (g) capacities for in- timacy and meaningful interpersonal relationships. They do not promote non-scientifically supportable methods of healing. Because the “holistic” label is a potential source of public confusion, informed observers have urged scientific practitioners to abandon it.27
“Detoxification” Many “CAM” proponents claim that people accumulate “toxins” and need periodic “detoxification.”28 Their chosen method depends on what they wish to market
and, if they have a license, the scope of their license. Naturopaths, for example, claim:
Toxins damage the body in an insidious and cumulative way. Once the detoxification system becomes overloaded, toxic metabolites accumulate, and sensitivity to other chemicals, some of which are not normally toxic, becomes progressively greater. This accumulation of toxins can wreak havoc on normal metabolic processes.29
Some proponents claim that intestinal sluggishness causes intestinal contents to putrefy, toxins are absorbed, and chronic poisoning of the body results. Many also suggest that fecal material collects on the lining of the colon and causes trouble unless removed by fasting, laxatives, colonic irrigation, special diets, and/or various herbs or food supplements that “cleanse” the body. The “autointoxication” theory that underlies these claims was popular around the turn of the century but was aban- doned by the scientific community during the 1930s. No relevant “toxins” have ever been found. Individuals in good health can vary greatly in bowel habits, and direct observations of the colon during diagnostic procedures or surgery indicate that fecal material does not adhere to the intestinal lining. Chelation therapy advocates falsely claim that lead, mercury, and/or other heavy metals commonly
√ Consumer Tip
Questions to Use for Evaluating “CAM” Methods
• Of what does the method consist? • Is it testable? Can its effects be measured? • Do its theories or practices clash with what is known?
• Is it based on vitalistic theory? • Is it claimed to be a complete system of diagnosis and/or treatment?
• Is its scope said to be limited or unlimited? • What evidence exists that it helps? Has scientific testing proven that it is more effective than doing nothing or using a placebo?
• What evidence exists that it harms? Has it been demonstrated that its potential benefit exceeds any potential for harm?
• Do its practitioners use standard diagnostic ter- minology? Are the conditions it claims to treat recognized by medical science?
• Are its practitioners adequately trained to make standard diagnoses and to stay within their scope?
• If you cannot answer all the above questions, how can you obtain the information needed to do so?
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accumulate in the body and should be removed by ad- ministering substances that cause them to be excreted (see pages 156–157). Chapter 7 describes how some dentists falsely claim that amalgam fillings cause mer- cury to accumulate and should be removed. Chapter 20 covers devices that supposedly detoxity Colonic irrigation (also called colon hydrotherapy) is intended to flush the entire length of the colon. The fluid may be plain water or contain enzymes, coffee, probiot- ics, ozone, and/or herbs. The amounts used range from a few gallons up to as much as 30 gallons, a few pints at a time. The fluid is delivered through a tube or speculum inserted into the rectum. Sessions generally last between 25 and 50 minutes and may include abdominal massage. Colonic irrigation has a few legitimate medical uses, such as preparation for surgery or radiologic endoscopy and for treating fecal incontinence, but its use for “de- toxification” is irrational—and severe complications (electrolyte imbalance, intestinal perforation, and infec- tions due to unsterile equipment) have been reported.30 In standard medical practice, the word “detoxifica- tion” refers to the management of withdrawal symptoms in people who stop abusing alcohol or controlled drugs. Such detoxification is not relevant to “CAM.”
Attitudes Toward Research As noted in Chapter 2, the science-based medical com- munity is committed to testing its theories and practices and accepts the accountability required by consumer protection laws. Science-based medical practice con- tinually changes as new findings point the way, but “true believers” in “CAM” cling to implausible and ineffective practices as a matter of faith. When advocates of questionable methods are chal- lenged about their lack of supportive scientific evidence, they typically claim that they lack the money or time to do research. However, preliminary research is simple to carry out and can be incorporated into clinical practice. The principal ingredients are careful clinical observa- tions, detailed record-keeping, and long-term follow-up “to keep score.” “CAM” practitioners rarely do these things. If rigorous clinical trials are conducted and come out negative, proponents often claim that the studies were conducted improperly or that the evaluators were biased.
hoMeopAThY
Homeopathy originated in the late 1700s when Samuel Hahnemann (1755–1843), a German physician, began
formulating its basic principles. Hahnemann was justi- fiably distressed about bloodletting, leeching, purging, and other “heroic” medical procedures of his day that did far more harm than good. He was also critical of medications like calomel (mercurous chloride), which many physicians considered a “cure-all” and prescribed in doses that caused mercury poisoning. At that time, medical practice was dominated by the ancient Greek theory that the human body was filled with four “humors” (black bile, yellow bile, phlegm, and blood) that are in balance when people are healthy and out of balance when they are ill. Standard medical practices, which Hahnemann labeled as “allopathic,” were thought to balance these humors through “op- posite” effects. In contrast, his “law of similars,” held that diseases can be cured with substances that would, if given to healthy people, cause the same symptoms as the disease. Hahnemann derived “allopathy” from the Greek words állos (different) and pathos (suffering) and the word “homeopathy” from homoios (similar) and pathos. Hahnemann and his early followers conducted “provings” in which they administered herbs, minerals, and other substances to healthy people, including them- selves, and kept detailed records of what they observed. Later these records were compiled into lengthy reference books called materia medica, which homeopaths still use to match a patient’s symptoms with a “corresponding” homeopathic remedy. Whorton31 has noted:
Hahnemann seems to have overlooked the fact that people regularly experience “symptoms,” unusual physical and emo- tional sensations, whether taking drugs or other stimulants, or not—especially if they have been forewarned that the experimental pills they have been given might, nay probably will, cause symptoms and that the symptoms might be mild and take several days or weeks to manifest themselves. . . . As provings by the master and his followers accumulated, homeopathic handbooks . . . grew thick with interminable symptom lists.
Hahnemann also declared that diseases represent an impairment of the body’s ability to heal itself and that only a small stimulus is needed to begin the healing process. To him, disease was chiefly a disturbance of the body’s “spirit.” At first he prescribed small doses of accepted medications. But later he used enormous dilu- tions and theorized that the smaller the dose, the more powerful the effect—a principle he called the “law of infinitesimals.” This principle is the opposite of what pharmacologists have demonstrated in dose-response studies. Novella32 has warned:
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Homeopathy represents perhaps the greatest disconnect between the scientific community and the public and regulators. Science has definitively spoken—homeopathy is dangerous witchcraft. But most countries treat it as if it were real medicine.
Far-Fetched Claims Many homeopaths maintain that certain people have a special affinity to a particular remedy (their “constitu- tional remedy”) and will respond to it for a variety of ailments. Such remedies can be prescribed according to the person’s “constitutional type”—named after the corresponding remedy in a manner resembling astrologic typing. The “Ignatia Type,” for example, is said to be nervous and often tearful, and to dislike tobacco smoke. The typical “Pulsatilla” is a young woman, with blonde or light-brown hair, blue eyes, and a delicate complexion, who is gentle, fearful, romantic, emotional, and friendly but shy. The “Nux Vomica Type” is said to be aggressive, bellicose, ambitious, and hyperactive. The “Sulfur Type” likes to be independent. And so on. Homeopathic products are derived from minerals, plant substances, and several other sources. If the original substance is soluble, one part is mixed with either 9 or 99 parts of distilled water and/or alcohol and shaken vigor- ously; if insoluble, it is finely ground and pulverized in similar proportions with powdered lactose (milk sugar). One part of the diluted preparation is diluted again at the same ratio, and the process is repeated until the desired concentration is reached. Purported dilutions of 1/10 are designated by the Roman numeral X (1X = 1/10, 3X = 1/1000, 6X = 1/1,000,000). Similarly, dilutions of 1/100 are designated by the Roman numeral C (1C = 1/100, 3C = 1/1,000,000, and so on). Most remedies today range from 6X to 30X, but products of 30C or more are marketed. (1C = 10X.) A 30X designation means that the original substance has been diluted 1030 times. Assuming that a cubic cen- timeter of water contains 15 drops, 1030 is greater than the number of drops of water that would fill a container more than 50 times the size of the Earth. Robert L. Park, Ph.D., a professor of physics at the University of Mary- land, has noted that since the least amount of a substance in a solution is one molecule, an actual 30C solution would have to have at least one molecule of the original substance dissolved in a minimum of 1060 molecules of water. This would require a container more than 30 billion times the size of the Earth. Betz33 has calculated that if everyone on Earth were to ingest three doses of a 30C product each day for 200 billion years, the chance that anyone would encounter a single molecule of the original substance would be infinitesimal.
According to the laws of chemistry, there is a limit to the dilution that can be made without losing the original substance altogether. This limit, which is related to Avogadro’s number (6.023 x 1023), corre- sponds to homeopathic potencies of 12C or 24X (1 part in 1024). Hahnemann himself realized there is virtually no chance that even one molecule of original substance would remain after extreme dilutions. But he believed that the vigorous shaking (“succussion”) or pulverizing with each step of dilution leaves behind a spirit-like es- sence, “no longer perceptible to the senses,” that cures by reviving the body’s “vital force.” If this were true, every substance encountered by a molecule of water might imprint an “essence” that could exert powerful and unpredictable medicinal effects when ingested. Many proponents claim that homeopathic products resemble vaccines because both provide a small stimulus that triggers an immune response. This comparison is not valid. The amounts of active ingredients in vaccines are much greater and can be measured, and potency increases with dosage. Moreover, immunizations pro- duce antibodies whose concentration in the blood can be measured, but dilute homeopathic products produce no measurable response. Hahnemann’s theories have never been accepted by scientifically oriented physicians, who charge that homeopathic remedies are placebos (inert substances). However, because homeopathic remedies were actu- ally less dangerous than those of nineteenth-century medical orthodoxy, many medical practitioners began using them. At the turn of the century homeopathy had some 14,000 practitioners and 22 schools in the United States alone. As medical science and medical education advanced, homeopathy declined sharply, particularly in America, where its schools either closed or converted to responsible methods. The last pure homeopathic school in the United States closed during the 1920s.34 Homeopathic preparations were given legal status by the 1938 Federal Food, Drug, and Cosmetic Act, which was shepherded through Congress by Senator Royal Copeland, a homeopathic physician.35 One provision of this law recognized as drugs all substances included in the Homœopathic Pharmacopœia of the United States. Now in its ninth edition, this book describes how more than 1200 substances should be prepared for homeo- pathic use.36 It states that inclusion of a substance means that it has been judged safe and effective. However, the symptoms or diseases for which it should be used are not identified; that is decided by the practitioner or manufacturer. Listing of the substances does not mean that either the law or the U.S. Food and Drug Adminis- tration (FDA) recognizes them as effective.37
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The basis for inclusion in the Homœopathic Pharma- copœia is not modern scientific testing, but homeopathic “provings,” many of which took place more than 100 years ago. Yet Jeremy Sherr,38 a British homeopath who wrote The Dynamics and Methodology of Provings, states that these provings had no consistency because “every homeopath had a different method.” Some used a single dose, others dosed as often as three times a day for months, and potencies ranged from the undiluted original substance to dilutions as high as 200C. (The number 100200 is vastly greater than the estimated number of molecules in the universe.) About 50 American physicians who prescribe ho- meopathic remedies practice anthroposophical medi- cine, a difficult-to-describe system based on the occult philosophy of Rudolf Steiner (1861–1925). Steiner’s teachings encompassed (a) a system of body movements termed “eurythmy”; (b) a peculiar educational approach that stresses art, drama, spiritual development, and “sci- ence” based on occult concepts; (c) a fanciful theory of medicine; and (d) “biodynamic” agriculture, a type of “organic” farming.39 Anthroposophical “remedies” are marketed in the United States through Weleda Inc. of Spring Valley, New York. According to a Weleda bro- chure, each plant used to prepare remedies is “selected for its unique ‘personality,’ revealed in form, color, pattern of growth, with consideration of its beneficial properties” and is “harvested when its growth forces are strongest.” Proponents also state that “seasonal changes” and “solar, lunar and planetary influences” are factors in determining when to harvest the plants.
Electrodiagnosis Many practitioners use “electrodiagnostic” devices to help select the homeopathic remedies they prescribe. These practitioners claim they can determine the cause of any disease by detecting the “energy imbalance” caus- ing the problem. Some also claim that the devices can detect whether someone is allergic or sensitive to foods, vitamins, and/or other substances. The procedure, called electroacupuncture according to Voll (EAV), electrodiag- nosis, or electrodermal screening, was begun during the 1950s by Reinhold Voll, M.D., a West German physician who developed the original device. Subsequent models include the Vegatest, Dermatron, Interro (Figure 8-2), and Biomeridian. Proponents claim these devices measure distur- bances in the flow of “electro-magnetic energy” along the body’s “acupuncture meridians.” Actually, they are fancy galvanometers that measure electrical resistance of the patient’s skin when touched by a probe.40 Each
device contains a low-voltage source. One wire from the device goes to a brass cylinder covered by moist gauze, which the patient holds in one hand. A second wire is connected to a probe, which the operator touches to “acupuncture points” on the patient’s foot or other hand. This completes a circuit, and the device registers the flow of current. The information is then relayed to a gauge that provides a numerical readout. The size of the number depends on how hard the probe is pressed against the patient’s skin. Newer versions make sounds and provide the readout on a computer screen. The treat- ment selected depends on the scope of the practitioner’s practice and may include acupuncture, dietary change, and/or vitamin supplements, as well as homeopathic products. Regulatory agencies have seized several types of electroacupuncture devices but have not made a system- atic effort to drive them from the marketplace. In 1991 the Australian College of Allergy issued a position paper stating that the use of a Vegatest device has no scientific basis and “may lead to inappropriate treatment and ex- pense to the patient and community.”41
Research Findings Edzard Ernst, M.D., Ph.D., F.R.C.P., professor of com- plementary medicine at Exeter University (England), has concluded that published research does not support the use of homeopathic products.42 After evaluating 11 previous reviews, he concluded:
figure 8-2. Interro device. Ampules containing homeopathic solutions may be placed in the metal honeycomb in the foreground to determine their alleged suitability for treating the patient.
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Collectively they failed to provide strong evidence in favour of homeopathy. In particular, there was no condition which responds convincingly better to homeopathic treatment than to placebo or other control interventions. Similarly, there was no homeopathic remedy that was demonstrated to yield clinical effects that are convincingly different from placebo. It is concluded that the best clinical evidence for homeopathy available to date does not warrant positive recommendations for its use in clinical practice.
Proponents present the few “positive” studies as proof that “homeopathy works.” Even if positive re- sults could be consistently reproduced by independent investigators, the most that the study of any homeopathic product for a specific disease could prove is that it was effective against that disease. It would not validate homeopathy’s basic theories or prove that homeopathic treatment is useful for other diseases. Critics also point out that if homeopathic products had any genuine value, that would have been clear by now.
A Multitude of Products Thousands of homeopathic products are available from practitioners, health-food stores, drugstores, multilevel distributors, and manufacturers who sell directly to the public. Homeopathic remedies appeal to some people who are afraid of potent drugs. Manufacturers cater to this fear by claiming that their remedies are “the safer alternative” and “work without side effects.” Some homeopathic manufacturers market 12 highly diluted mineral products called “cell salts” or “tissue salts.” These are claimed to be effective against a wide variety of diseases, including appendicitis (ruptured or not), baldness, deafness, insomnia, and worms. Their use is based on the notion that mineral deficiency is the basic cause of disease. However, many are so diluted that they could not correct a mineral deficiency even if one were present. Development of this approach is attributed to nineteenth-century physician W.H. Schuessler. Many homeopathic products have been marketed with illegal claims of efficacy against serious diseases. In 1983, for example, Biological Homeopathic Industries (BHI) of Albuquerque, New Mexico, marketed BHI Anticancer Stimulating, BHI Antivirus, BHI Stroke, and 50 other types of products that the company claimed were effective against serious diseases. In 1984 the FDA forced BHI to stop distributing several of the products and to tone down its claims for the rest. However, the company has continued to make illegal claims. Its refer- ence books, posted on distributor Web sites, inappropri- ately recommend products for glaucoma, heart failure, hepatitis, paralysis, syphilis, kidney failure, blurred vision, and a multitude of other problems.43
Many other companies market brazenly named homeopathic products for over-the-counter sale. Some examples are: Arthritis Formula, Bleeding, Candida Yeast Infection, Candida-Away, Cardio Forte, Epilepsy Drops, Exhaustion, Flu, Gall-Stones, Gonorrhea, Heart Tonic, Herpes, Kidney Disorders, Prostate Pain, Whoop- ing Cough, Thyro Forte, and Worms. Homeopathic products called nosodes are made from pathologic organs or tissues; causative agents such as bacteria, fungi, ova, parasites, virus particles and yeast; disease products; or excretions. In recent years, the FDA has ordered several companies to stop marketing nosodes claimed to be substitutes for influenza or anthrax vaccine.
Lack of Consumer Protection Public protection regarding drugs is based on a frame- work of federal laws and regulations that require drugs to be safe, effective, and properly labeled. However, the FDA has not applied these rules to homeopathic products. Because most are supposed to contain no detectable amount of any active ingredient, it is impos- sible to test whether their ingredients are those stated on their labels. They have been presumed safe, but unlike most other drugs, they have not been proven safe or effective against disease by scientific means (such as double-blind testing). If the FDA were to require such proof for homeopathic drugs to remain on the market, the industry would not survive unless the U.S. Congress granted it new privileges. In most states homeopathy can be practiced by any physician or other practitioner whose license includes the ability to prescribe drugs. Three states—Arizona, Nevada, and Connecticut—have separate homeopathic licensing boards. Arizona and Nevada are notable be- cause some of their practitioners acquired homeopathic licenses after other states revoked their medical licenses for providing quack treatments. Even worse, the Arizona and Nevada homeopathic boards permit their licensees to provide many dubious treatments. In 2010, the National Center for Homeopathy’s online directory listed about 600 licensed practitio- ners. About 160 were physicians and the rest were mostly dentists, veterinarians, nurses, chiropractors, and naturopaths. Consumers interested in homeopathic self-treatment can obtain guidance through lay study groups, books, and courses sponsored by the center. Many homeopaths display credentials that have no scientific standing and do not reflect greater ability to help people. These include: certified classical homeo- path (CCH), diplomate in homeotherapeutics (dHt), diplomate of the Homeopathic Academy of Naturopathic
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Physicians (DHANP), diplomate of the National Board of Homeopathic Examiners (DNBHE), and certified veterinary homeopath (CVH).
In 1987 Consumer Reports45 concluded:
Unless the laws of chemistry have gone awry, most homeo- pathic remedies are too dilute to have any physiological effect. . . . Any system of medicine embracing such remedies involves a potential danger to patients whether the prescribers are M.D.s, other licensed practitioners, or outright quacks. Ineffective drugs are dangerous drugs when used to treat serious or life-threatening disease. Moreover, even though homeopathic drugs are essentially nontoxic, self-medication can still be hazardous. Using them for a serious illness or un- diagnosed pain instead of obtaining proper medical attention could prove harmful or even fatal.
In 1994 Consumer Reports urged Congress to “re- move the blanket exemption from drug laws enjoyed by homeopathic remedies” and recommended that remedies marketed as treatments for specific illnesses be removed from drugstore shelves unless they are tested and proven safe and effective.46 A few months later two authors of this textbook and 40 other critics of quackery and pseudoscience petitioned the FDA to require that all over-the-counter homeopathic drugs meet the same standards of safety and effectiveness as nonhomeopathic over-the-counter drugs. The petitioners also asked the FDA Commissioner to issue a public warning that al- though the agency has permitted homeopathic remedies to be sold, it does not recognize them as effective.47 The FDA chose to side-step the issue by neither accepting nor rejecting the petition.
ACupunCTure And TCM “Chinese medicine,” often called “Oriental medicine” or “traditional Chinese medicine (TCM),” encompasses
a vast array of folk medical practices based on ancient cosmologic beliefs.48 It holds that the body’s vital energy (chi or qi) circulates through 14 channels, called merid- ians, that have branches connected to bodily organs and functions. Illness is attributed to imbalance or interrup- tion of chi (Figure 8-3). Practices such as acupuncture are claimed to restore balance. Acupuncture, as now practiced, involves the inser- tion of stainless steel needles into various body areas. A low-frequency current may be applied to the needles to produce greater stimulation. Other procedures used separately or together with acupuncture include moxi- bustion (burning of floss or herbs applied to the skin); injection of sterile water, procaine, morphine, vitamins, or homeopathic solutions through the inserted needles; applications of laser beams (laserpuncture); placement of needles in the external ear (auriculotherapy); and acu- pressure (use of manual pressure). Treatment is applied to “acupuncture points,” which are said to be located
figure 8-3. Acupuncture chart. This chart identifies the locations for treating the lungs. The lung “meridian” is shown running along the inner arm and into the shoulder.
Bottom Line Advice on Homeopathy44
In 1999, The Medical Letter on Drugs and Therapeutics, which is the medical profession’s most trusted drug advisory newsletter, summed up what its readers should tell their patients: The chemical content of homeopathic products is often undefined, and some are so diluted that they are unlikely to contain any of the original material. These products have not been proven effective for any clinical condition. There is no good reason to use them.
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throughout the body. Skrabanek49 has noted that origi- nally there were 365 such points, corresponding to the days of the year, but the number identified by proponents during the past 2000 years has increased gradually to over 2000. Some practitioners place needles at or near the site of disease, whereas others base their selection on symptoms. A combination of points is usually used. Most acupuncturists espouse the traditional Chinese view of health and disease and consider acupuncture, herbal medicine, and related practices to be valid ap- proaches to the full gamut of disease. Others reject the traditional approach and merely claim that acupuncture offers a simple way to achieve pain relief. The diagnostic process used by practitioners of Chinese medicine may include questioning (medical history, lifestyle), observa- tions (skin, tongue, color), listening (breathing sounds), and pulse-taking. Six pulse aspects said to correlate with body organs or functions are checked to determine which meridians are “deficient” in chi. (Medical science rec- ognizes only one pulse, corresponding to the heartbeat, which can be felt in the wrist, neck, feet, and several other places.) Some acupuncturists state that the electrical proper- ties of the body may become imbalanced weeks or even months before symptoms occur.50 These practitioners claim that acupuncture can be used to treat conditions when the patient just “doesn’t feel right,” even though no disease is apparent. Acupuncture anesthesia is not used for surgery in the Orient to the extent that its proponents suggest.51
In China, physicians screen out patients who appear to be unsuitable. Acupuncture is not used for emergency surgery and often is accompanied by local anesthesia or narcotic medication.
Research Overview In 1997, a Consensus Development Conference spon- sored by the National Institutes of Health and several other agencies issued a favorable acupuncture report. However, critics were excluded from participating, so that the meeting resulted in “a consensus of proponents, not a consensus of valid scientific opinion.”52 To demonstrate that acupuncture is effective, it would be necessary to compare the outcome when groups of people who are treated with acupuncture are compared with similar people who are not. Many clinical trials of acupuncture in treating a variety of conditions have been carried out, but conclusions that acupuncture treatments are therapeutic are not supported in studies with proper blinding and sham-acupuncture control groups. Sham acupuncture involves applying needles at “incorrect”
points or using devices that provide the sensation of needle penetration without actual penetration. High- quality trials have found that it doesn’t matter where needles are placed. Ernst and Singh53 have concluded that (a) the better the study design, the greater tendency for the results to indicate that acupuncture is little more than a placebo, (b) most “positive” trials lacked adequate control groups and were poorly designed, and (c) for some types of pain, some high-quality trials support the use of acu- puncture, but other high-quality trials contradict this conclusion. The perceived effects of acupuncture are likely due to expectation, suggestion, distraction, conditioning, and/or other psychologic mechanisms. Body chemistry changes following acupuncture have been observed,54 but similar changes have been found in placebo studies.55
To conclude that acupuncture has practical use, it would have to be proven as effective and cost-effective as standard medical treatment. That has never been demonstrated.
Risks Improperly performed acupuncture can cause fainting, local hematoma (due to bleeding from a punctured blood vessel), pneumothorax (punctured lung), convulsions, local infections, hepatitis B (from unsterile needles), bacterial endocarditis, contact dermatitis, and nerve damage. The herbs used by acupuncture practitioners are not regulated for safety, potency, or effectiveness. There is also risk that an acupuncturist whose approach to diagnosis is not based on scientific concepts will fail to diagnose a dangerous condition. The data on the incidence of adverse effects are inconsistent. A survey of 1135 Norwegian physicians re- vealed 66 cases of infection, 25 cases of punctured lung, 31 cases of increased pain, and 80 other cases with com- plications.56 A parallel survey of 197 acupuncturists, who are more apt to see immediate complications, yielded 132 cases of fainting, 26 cases of increased pain, eight cases of pneumothorax, and 45 other adverse results.56 On the other hand, a 5-year study involving 76 acupuncturists at a Japanese medical facility tabulated only 64 adverse event reports (including 16 forgotten needles and 13 cases of transient low blood pressure) associated with acupuncture treatments. No serious complications were reported. The researchers concluded that serious adverse reactions are uncommon among acupuncturists who are medically trained.57 However, Gorski has pointed out that if an expected benefit is zero, or near zero, then even a tiny risk is unacceptable.58
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TCM poses additional risks because its concepts have little relationship to anatomy and physiology and the diagnoses made by its practitioners may have little to do with people’s actual health problems. One study has found that acupuncture literature does not provide a consistent framework for evaluating patients. At least six studies have found that when multiple practitioners saw the same patient, their TCM diagnoses varied con- siderably.59 In one such study, a 40-year-old woman with chronic back pain visited seven acupuncturists. During a 2-week period she was diagnosed with “Qi stagnation” by six of them, “blood stagnation” by five, “kidney Qi deficiency” by two, “yin deficiency” by one, and “liver Qi deficiency” by one. The proposed treatments varied even more. Among the six who recorded their recom- mendations, the practitioners planned to use between seven and 26 needles inserted into four to 16 specific “acupuncture points” in the back, leg, hand, and foot. Of 28 acupuncture points selected, only four (14%) were prescribed by two or more acupuncturists.60
Government Regulation The FDA classifies acupuncture needles as Class II medical devices and requires labeling for one-time use by practitioners who are legally authorized to use them. This classification merely addresses safety and does not authorize marketing them with health claims. Acupunc- ture is not covered under Medicare.
Nearly all states authorize the practice of acupunc- ture through licensure, registration, or certification.61 Most permit independent practice and the use of other TCM and “CAM” modalities. Eligibility requires gradu- ation from a 3-year acupuncture program or a 4-year Oriental medicine program accredited by the Accredita- tion Commission for Acupuncture and Oriental Medicine (ACAOM). Oriental medicine programs include consid- erably more study of TCM theory, diagnosis, and herbal treatment. The credentials used by acupuncturists vary by state and include C.A. (certified acupuncturist), M.A. (master acupuncturist), D.A. (diplomate of acupuncture), and O.M.D. (doctor of Oriental medicine). The ACAOM was recognized by The U.S. Secretary of Education in 1988 to accredit acupuncture programs and in 1992 to accredit programs in Oriental medicine. However, such recognition is not based on the scientific validity of what is taught but on other criteria. (See His- torical Perspective box.)
nATuropAThY
Naturopathy, sometimes referred to as “natural medi- cine,” is a hodgepodge of methods said to “assist nature.” Naturopaths claim to remove the underlying cause(s) of disease and to stimulate the body’s natural healing processes. They maintain that diseases are the body’s
Historical Perspective
The Limitations of Accreditation In the United States, educational standards are set by a network of agencies approved by the U.S. Office of Education (USOE) or the Council on Recognition of Postsecondary Accreditation (CORPA). Accreditation constitutes public recognition that an educational program meets the administrative, organizational, and financial criteria of a reviewing body recognized by one of these agencies. USOE and CORPA do not accredit individual schools, but they approve the national and regional agen- cies that do so. Almost all such agencies are voluntary and nongovernmental. Accreditation enables credits to be transferable from one school to another and is used as a basis for entering various professions. Accreditation has been a powerful impetus to quality education. But in recent years the system has been com- promised by USOE recognition of agencies that oversee unscientific teachings. USOE recognition is supposed to mean that an accrediting agency is “a reliable authority as
to the quality of training offered.”62 However, the criteria are primarily organizational. To achieve recognition, the agency must be national or regional in scope and must have appropriate bylaws, procedures, institutional and public representation, “reliability,” and autonomy. Individual schools, in turn, must meet criteria set by the recognized agency. The criteria do not include scientific validity. Although much of what is taught in chiropractic, naturopathic, acupuncture, and massage schools is ques- tionable, agencies for each have been recognized. While the naturopathic agency was undergoing evaluation for renewal, a USOE official actually said that if astrologers could get the required paperwork in order, they too could get an agency approved.63 Even worse, the agencies that accredit standard medi- cal education programs have done little or nothing to stem the teaching of irrational “CAM” practices to physicians and medical students.64
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effort to purify itself and that cures result from increas- ing the patient’s “vital force” by ridding the body of waste products and “toxins.” Although naturopaths say they emphasize prevention, they tend to oppose standard vaccinations. The term “naturopathy” was coined in 1895 by John Scheel, a practitioner in New York City. In 1902 he sold rights to the term to Benedict Lust, who had come to the United States in 1892 to promote the Kneipp Water Cure, a form of hydrotherapy. Lust was largely responsible for naturopathy’s growth in this country.65 Another promi- nent developer of naturopathy was Bernarr Macfadden, who promoted “physical culture” (see Chapter 13). Most naturopaths believe that virtually all diseases are within the scope of their practice. They offer treat- ment at their offices and at spas where patients may reside for several weeks. Their methods include fasting; “natural food” diets; vitamins; herbs; tissue minerals; cell salts; manipulation; massage; exercise; colonic ir- rigation; acupuncture; natural childbirth; minor surgery; and applications of water, heat, cold, air, sunlight, and electricity. They may use radiation for diagnosis but not for treatment. The doctor of naturopathy (N.D.) degree is avail- able from four full-time naturopathy schools and sev- eral nonaccredited correspondence schools. Training at the full-time schools includes 2 years of basic science courses and 2 years of clinical naturopathy. Two years of preprofessional college work are required for admis- sion. In 1987 the U.S. Secretary of Education approved
the Council on Naturopathic Medical Education as an accrediting agency for the full-time schools. The largest naturopathy school is Bastyr University in Seattle. Naturopaths are licensed as independent practitio- ners in 16 states and may legally practice in a few oth- ers. Correspondence school graduates are generally not eligible for licensure, but many of them practice anyway. The Naturopathy Digest Web site (www.naturopathy- digest.com), which maintains a directory of licensed naturopaths, lists about 1300, two-thirds of whom are located in Oregon, Arizona, and the state of Washing- ton. The total number of practitioners is unknown but includes chiropractors and acupuncturists who use natu- ropathic methods. Medicare and most insurance policies do not cover naturopathic services. Most states that license naturopaths permit them to prescribe standard drugs listed in a formulary approved by their licensing board. However, their clinical training in the use of these drugs is minuscule compared to that of medical school and residency programs.
Dubious Practices Many naturopathic practices have not been scientifically substantiated, and some—such as the use of homeopa- thy—clearly are worthless. In many cases, naturopaths combine sensible dietary advice (based on medically proven strategies) with senseless recommendations for products. The most comprehensive naturopathic publica- tions, Textbook of Natural Medicine66 (for students and professionals) and Encyclopedia of Natural Medicine67 (for laypersons), recommend special diets, vitamins, minerals, and/or herbs for more than 70 health problems ranging from acne to AIDS. For many of these condi- tions, daily administration of 10 or more products is recommended—some in dosages high enough to cause toxicity. Arnold Relman, M.D., reviewed the textbook’s second edition and concluded68:
Many of the treatments recommended in the Textbook for the 70 diseases are not likely to be effective, and treatments proven to be effective are often totally ignored. This could endanger the health and safety of patients with serious diseases who relied solely on care from a naturopathic practitioner.
In naturopathic practice, “detoxification” plays a central role. The Textbook of Natural Medicine states that “toxins” accumulate insidiously in everyone and:
Detoxification as a specific therapeutic activity should be considered as a periodic means to improve vitality and reduce toxic body burdens. . . . Nutritionally controlled fasting for 5 to 7 days with every change of seasons is a reasonable
Be Wary of Acupuncture • Acupuncture is an invasive procedure (penetrates the skin). Although the complication rate is low, acupuncture can cause serious complications.
• Many practitioners of acupuncture do not have adequate training and use unscientific approaches to the diagnosis and treatment of health problems.
• There is no evidence that acupuncture can influence the course of any organic disease.
• Pain relief from acupuncture, if it occurs, is likely to be short-lived.
• Consumers who wish to try acupuncture should choose a practitioner who is medically trained and does not espouse ancient superstitions or any other nonscientific approach described in this chapter.
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recommendation for clinicians to make to their patients. Another alternative is to have patients undergo a nutrition- ally controlled fast 1 day per week on an ongoing basis. In addition, natural health care providers may use more intensive or lengthier detoxification programs for specific conditions responsive to these interventions.
A 1968 U.S. Department of Health, Education, and Welfare (HEW) report69 that recommended against Medicare coverage concluded:
Naturopathic theory and practice are not based upon the body of basic knowledge related to health, disease, and health care which has been widely accepted by the scientific community. Moreover, irrespective of its theory, the scope and quality of naturopathic education do not prepare the practitioner to make an adequate diagnosis and provide appropriate treatment.
Although some aspects of naturopathic education have improved in recent years, this conclusion is still valid.
nATurAl hYgiene
Natural hygiene, an offshoot of naturopathy, is a phi- losophy of “natural living” that denounces most medical treatment and advocates (a) eating a “raw food” diet of vegetables, fruits, and nuts, (b) periodic fasting, and (c) “food combining” (avoiding food combinations it considers detrimental).70 Its best-known advocates are Harvey and Marilyn Diamond, authors of Fit for Life (discussed in Chapter 12). Natural hygiene’s primary organization is the Na- tional Health Association (NHA), which was founded in 1948 by Herbert M. Shelton (1895–1985) as the Ameri- can Natural Hygiene Society (ANHS) and assumed its present name in 1998. An ANHS brochure stated:
Natural Hygiene rejects the use of medications, blood trans- fusions, radiation, dietary supplements, and any other means employed to treat or “cure” various ailments. These therapies interfere with or destroy vital processes and tissue. Recovery from disease takes place in spite of, and not because of, the drugging and “curing” practices.
The NHA has been active in promoting “organic food” certification and opposing fluoridation, food ir- radiation, and mandatory vaccination.
iridologY
Iridology is based on the notion that each area of the body is represented by a corresponding area in the iris of the eye (the colored area around the pupil), as shown in Figure 8-4. According to this viewpoint, a person’s state of health and disease can be diagnosed from the
color, texture, and location of various pigment flecks in the eye. Iridology practitioners claim to diagnose “im- balances” that can be remedied with vitamins, minerals, herbs, and similar products. Some also claim that the eye markings can reveal a complete history of past ill- nesses as well as previous treatment. One textbook, for example, stated that a white triangle in the appropriate area indicates appendicitis, but a black speck indicates that the appendix had been removed by surgery. Iridology charts—dozens of which exist—vary somewhat in the location and interpretation of their iris signs. Sclerol- ogy is similar to iridology but interprets the shape and condition of blood vessels on the white portion (sclera) of the eyeball. Proponents of iridology attribute its development to Ignatz von Peczely, a Hungarian physician who, during his childhood, had accidentally broken the leg of an owl and noticed a black stripe in the lower part of the owl’s eye. Nonadherents suggest that von Peczely may have developed his theory to pass time while he was imprisoned after the 1848 Hungarian revolution. After his release from prison he allegedly saved the life of his mother with homeopathic remedies, recalled the incident of the owl’s eye, and began studying the eyes of his patients. The late Bernard Jensen, D.C., who was the leading American iridologist, stated that “Nature has provided
figure 8-4. Iridology chart of the left eye developed by a prominent naturopath more than 70 years ago.
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us with a miniature television screen showing the most remote portions of the body by way of nerve reflex responses.”71 He also claimed that iridology analyses are more reliable and “offer much more information about the state of the body than do the examinations of Western medicine.” However, in 1979 he and two other proponents failed a scientific test in which they examined photographs of the eyes of 143 persons in an attempt to determine which ones had kidney impair- ments. (Forty-eight had been diagnosed with a standard kidney function test, and the rest had normal function.) None of the three iridologists performed significantly better than would be expected by random guessing. One iridologist, for example, decided that 88% of the normal patients had kidney disease, while another judged that 74% of patients sick enough to need artificial kidney treatment were normal.72 In 1988, five leading Dutch iridologists failed a similar test in which they were shown stereo color slides of the right iris of 78 people, half of whom had gallbladder disease. None of the five could distinguish between the patients with gallbladder disease and the people who were healthy. Nor did they agree with each other about which was which.73 Russell S. Worrall, O.D., has noted74: Many of the conditions detected by practitioners of iridology are “diseases” whose existence has been disputed or dis- credited by scientific investigation. . . . It would be difficult to agree on a standard diagnosis where the existence of the disease itself is in dispute.
Worrall also pointed out how incorrect “diagnoses” by iridologists can have serious consequences, as illustrated by the case of an accountant who consulted a chiroprac- tor who practiced iridology: During the course of treatment an iridology workup was recommended. The results indicated, among many other health problems, the presence of cancer. Overwhelmed, the patient spent the day in torment. Unable to consult his family physician . . . he finally sought my advice. After a lengthy discussion, I was able to allay his fears. . . . He wondered how an intelligent person such as himself could be caught up in such a deep emotional web over such a diagnosis. The story fortunately had a pleasant ending. However, the outcome could have been much more serious since the patient is also suffering from a heart condition, which was not noted on the iridology evaluation!
Stalker and Glymour26 have observed: Chiropractors, iridologists, reflexologists, tongue diagnosers . . . and many others all claim to treat or diagnose the whole from some anatomical part. Of course, they differ about which part, but that does not seem to bother either them or the editors of holistic books.
reflexologY
Reflexology, often called zone therapy, is based on the notion that pressing on the hands or feet can help re- lieve pain and remove the underlying cause of disease in other parts of the body. Most proponents claim that (a) the body is divided into 10 zones that begin or end in the hands and feet; (b) each organ or part of the body is represented on the hands and feet; (c) the practitioner can diagnose abnormalities by feeling the feet; and (d) massaging or pressing each area can stimulate the flow of energy, blood, nutrients, and nerve impulses to the corresponding body zone. Figure 8-5 shows a simple reflexology chart. Many proponents claim that foot reflexology can cleanse the body of toxins, increase circulation, assist in weight loss, and improve the health of organs throughout the body. Other proponents have reported success in treating a wide range of diseases. There is no scientific support for such assertions. The pathways postulated by reflexologists have not been anatomically demonstrated, and it is safe to assume that they do not exist. Barrett75 has noted:
Reflexology is based on an absurd theory and has not been demonstrated to influence the course of any illness. Done gently, reflexology is a form of foot massage that may help people relax temporarily. Whether that is worth $35 to $100 per session or is more effective than ordinary (noncommer- cial) foot massage is a matter of individual choice. Claims that reflexology is effective for diagnosing or treating disease should be ignored. Such claims could lead to delay of neces- sary medical care or to unnecessary medical testing of people who are worried about reflexology findings.
figure 8-5. Simple reflexology diagram. According to proponents, pressing on the shaded areas influences the parts of the body listed.
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CrAniAl TherApY
Craniosacral therapy—also called craniopathy, cranial therapy and cranial osteopathy—is based on the notion that the skull bones can be manipulated to relieve pain (especially of the jaw joint) and remedy many other ail- ments. Its practitioners also claim that a rhythm exists in the flow of the fluid that surrounds the brain and spinal cord and that diseases can be diagnosed by detecting aberrations in this rhythm and corrected by manipulating or lightly touching the skull. However (a) the bones of the skull fuse by the end of adolescence, (b) no research has ever demonstrated that manual manipulation can move them, (c) studies have found that practitioners who examine the same patient do not agree about what they are feeling, and (d) there is no logical reason why pressing the skull should influence the course of ailments throughout the body.76 Most practitioners are osteopathic physicians, massage therapists, chiropractors, dentists, or physical therapists.
AroMATherApY
Aromatherapy is based on the notion that inhaling the odors of plant oils can relieve stress and help heal hun- dreds of diseases and conditions.77 Some proponents say that the oils represent the “life force” of plants. Pleasant odors can be enjoyable and may enhance people’s efforts to relax. However, there is no evidence that aromatherapy products provide the health benefits claimed by their proponents. In addition, some can cause allergic reactions.
“energY heAling” Various “CAM” methods are based on the notion that the body is surrounded or permeated by an energy field that is not measurable by ordinary scientific instrumentation. Practitioners claim to improve health by strengthening or “balancing” the alleged force.
Therapeutic Touch Therapeutic touch (TT) was developed during the 1970s by Dolores Krieger, Ph.D., R.N., who for many years was a nursing professor at New York University. Proponents claim that it is possible to use one’s hands to detect when someone is ill, pinpoint areas of pain, reduce anxiety, and stimulate the sick person’s recuperative powers. Most practitioners are nurses, many of whom consider themselves “holistic.” Proponents claim that more than 40,000 nurses have been trained in its use.
As taught by Krieger, TT involves four steps: (1) “centering,” a meditative process said to align the healer with the patient’s energy level; (2) “assessment,” said to be performed by using one’s hands to detect forces emanating from the patient; (3) “unruffling the field,” said to involve sweeping “stagnant energy” downward to prepare for energy transfer; and (4) transfer of “energy” from practitioner to patient. The “healer’s” hands are held a few inches away from the body. Critics who reviewed more than 800 reports have concluded that no well-designed study demonstrates any health benefit from TT. In 1998, the Journal of the American Medical Association published this conclu- sion together with the results of testing whether TT practitioners could detect the “energy field” they claim to manipulate. During the testing, the practitioners rested their forearms and hands, palms up, on a flat surface. The experimenter (Emily Rosa, who was 9 when the study began and 10 when it ended) then hovered her hand, palm down, a few inches above one of the subject’s palms. A cardboard screen and a draped towel were used to pre- vent the subjects from seeing which hand was selected (Figure 8-6). The practitioners correctly located Emily’s hand only 122 (44%) out of 280 trials, which was no better than would be expected by guessing. The authors concluded that TT claims are groundless and that further use of TT by health professionals is unjustified.78
Reiki Practitioners of reiki claim to harness and transmit “uni- versal life energy” by placing their hands in specific posi-
Figure 8-6. Emily Rosa testing whether a therapeutic touch practitioner can detect the presence of her hand.
(Drawing by Pat Linse, Skeptics Society.)
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tions on or near the body, or through absentee healing. Reiki can also be self-administered. Some practitioners say that “spirit guides” help them produce the proper flow of energy. To become a practitioner, one must receive an “initiation” or “attunement” from a Reiki Master. This ceremony makes one “attuned” to the “universal life energy” and enables one to serve as a conduit for it. At higher levels of attunement, one can allegedly channel reiki energy and effect healings at a distance, without physical contact. Training for the lower levels typically takes 1 or 2 days and begins with an attunement. Training to become a Master is said to take years. Many practi- tioners are massage therapists. However, no licensing or professional standards exist for the practice of reiki itself. Whether reiki can be considered the unlicensed practice of medicine varies from state to state. The most comprehensive review of reiki research was done by Lee and colleagues79 at the University of Exeter. After surveying studies published through Janu- ary 2008, they concluded that most were poorly designed and “the evidence is insufficient to suggest that reiki is an effective treatment for any condition.”
Kirlian Photography Many TT practitioners and other psychic healers claim that they effect changes in the body’s “energy field” demonstrable with Kirlian photography, which alleg- edly reveals the body’s “aura.” During this procedure the object (such as a person’s hand) is placed on photo- graphic paper or film in an apparatus that generates a high-voltage, low-amperage, high-frequency electric current. The film is then exposed by air glow that occurs when electrical discharges pass between the subject and apparatus through the photographic material. Randi80 has demonstrated that the pictures reflect the amount of finger pressure applied to the camera, as well as the amount of electrical grounding produced by con- tact between the apparatus and the subject’s body. Other researchers have demonstrated that the photographic images are also affected by perspiration and many other factors and that coins, which presumably lack a human aura, can generate them.
MAssAge TherApY
Massage is customarily defined as manual (by hand) ma- nipulation of the soft tissues of the body for therapeutic purposes, using strokes that include gliding, kneading, pressing, tapping, and/or vibrating. Massage therapists may also cause movement within the joints, apply heat or cold, use holding techniques, and/or advise clients on
exercises to improve muscle tone and range of motion. The best known forms are sports massage, which focuses on muscle systems relevant to a particular sport, and Swedish massage which uses long strokes, kneading, and friction techniques on muscles, plus active and passive movements of the joints. Massage can help people relax, relieve aching muscles, and temporarily lift a person’s mood. How- ever, many therapists make claims that go far beyond what massage can accomplish. The American Massage Therapy Association (AMTA) has claimed that (a) “mas- sage is to the human body what a tune-up is to a car,” (b) “therapeutic massage can be part of your regular healthcare maintenance,” and (c) therapeutic massage can promote easier breathing, assist with removal of metabolic wastes, strengthen the immune system, help prevent disease and can help with allergies, asthma, bronchitis, spastic colon, constipation, diarrhea, and sinusitis.81 All but a few states license or register massage therapists.61 Most states that license require graduation from an approved 500-hour course and passage of an examination. The marketplace is complicated by the fact that most of the schools promote aromatherapy, cranial therapy, reflexology, reiki, and therapeutic touch in their teaching and about half of the practicing massage therapists use these methods.82
psYChiC heAling
The term “psychic healing” refers to an alleged ability to treat illness without using any type of drug, surgery, or other curative agent that is physical, measurable, or explainable by currently accepted scientific methods or theories. Psychic healing is also referred to as faith healing, paranormal healing, divine healing, miracle healing, spiritual healing, shamanistic healing, mental healing, psi healing, and the laying-on of hands, although these terms are not interchangeable. Faith-healing practices are based on a belief that religious faith can bring about recovery, or that prayer and faith in a healer can result in a cure through divine intervention. A high degree of confidence in the efficacy of the healer is usually thought to be the central element in faith healing. However, nonreligious individuals sometimes feel healed or act as healers, and some pro- cedures take place in secular settings.83 Spiritual healers postulate that humans can influence supernatural beings or forces. Some secular healers claim to have an intrinsic power of their own—such as a healing touch—which they may attempt to demonstrate by Kirlian photography or other means.
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Attempts at healing by faith and magic have been made throughout history. Ancient medicine functioned with the belief that diseases were caused by demons. Ear- ly Assyrian tablets describe methods of curing illnesses by driving out demons with magic, charms, incantations, and rituals. In the famous Greek temples of Aesculapius, religious methods of healing were employed. Christian history is replete with examples of widespread belief in the efficacy of faith healing. Shrines such as Lourdes in France still attract large numbers of people who hope to be cured by an intense religious experience. The 2002 National Health Interview Survey84 found that approximately 45% of the respondents had engaged in health-related personal prayer or rituals. Although prayer comforts many people confronted with serious illness, no evidence demonstrates that it influences the course of disease. This section highlights investigative reports and scientific studies related to curative claims. Evangelical Healers Many evangelical faith healers attract large followings. All claim to possess a gift of “miracle healing,” but some express faith in the medical profession as well. Some appear to hold sincere beliefs, whereas others engage in clear-cut fraud motivated by greed. Kathryn Kuhlman, for many years the queen of faith healers in the United States, was an energetic woman who attracted large crowds to her healing services. Close evaluation of her work, however, was unfavorable. Wil- liam Nolen, M.D., a Minnesota surgeon, was permitted to attend one of her services. Afterward he examined or interviewed many people who claimed to have been healed during the service. Not one person with organic disease had actually been helped.85 Ms. Kuhlman died in 1976, not long after undergoing open heart surgery. In 1985, magician James Randi and associates intercepted radio transmissions that proved that faith healer Peter Popoff was not getting information about the ailments of his audiences from God, as he claimed, but from his wife, who was backstage. The investigators also saw that people capable of walking were placed in wheelchairs before televangelist W.V. Grant’s perfor- mances, so that later he could help “cripples” walk. After extensive investigations, Randi86 concluded:
Claims made by faith healers are nothing more than hollow boasts, and do not stand up to examination. Prepared culturally to expect miracles, convinced they are helpless without super- natural intervention, and bullied into supporting their gurus far beyond their means, the pathetic victims of the healers become a disillusioned subculture playing a dangerous game. . . . They are the dupes of clever, glib, highly organized swindlers who are immune from justice and are confidently aware of that fact.
In 1996, Grant pleaded guilty to income tax evasion and was sentenced to serve 16 months in prison and pay a fine of $60,812.88. Documents in the case indicate that he had accumulated at least $300,000 in cash that he had failed to report as income.87 Despite their scandals, Popoff and Grant are still in business. Today’s leading evangelistic “healer” is Benny Hinn, who uses many of Kuhlman’s techniques. After he an- nounces that miracles are taking place, he and his staff select believers to announce their “healing” onstage. About ten years ago, following one of his performances, Hinn’s staff gave reporters the names of 5 people out of 76 who had supposedly been healed. After following each of them for up to one year, the reporters found that one had died and the other four had not been helped.88
Christian Science Christian Science, which was founded by Mary Baker Eddy in the 1870s, contends that illness is an illusion caused by faulty beliefs and that prayer heals by replac- ing bad thoughts with good ones. Its practitioners work by trying to argue the sick thoughts out of the patient’s mind. Consultations can take place in person, by tele- phone, or even by mail or e-mail. Individuals may also be able to attain correct beliefs by themselves through prayer or concentration. A pamphlet of the Christian Science Publishing Society states that “every student of Christian Science has the God-given ability to heal the sick.” To become a practitioner, an individual takes 2 weeks of “primary class instruction” from a qualified teacher. The course is based on questions and answers from Science and Health. When training is completed, “C.S.” may be placed after the person’s name. After 3 years of full-time practice, a practitioner may apply for the 6-day “normal class.” Completion merits the degree of Bachelor of Christian Science (C.S.B.) and certifies the person as a teacher who may give primary instruction to 30 pupils a year. Since 1971 the number of practitioners and teach- ers listed in the Christian Science Journal has steadily declined from about 5000 to about 300 and the number of churches has fallen from about 1800 to about 900.89
Devout Christian Scientists do not use medications and usually eschew medical aid. They are opposed to vaccination, immunization, and quarantine for conta- gious diseases, although official church policy advises members to comply with state laws. A physician or midwife may be used during childbirth. A physician may also be used to set a broken bone if no medication is administered. Eyeglasses, hearing aids, and dental treatment are used by some members who still maintain that illness is the consequence of mental error.
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The weekly magazine Christian Science Sentinel publishes several “testimonies” in each issue. To be considered for publication, an account must merely be “verified” by three individuals who “can vouch for the integrity of the testifier or know of the healing.” Be- lievers have claimed that prayer has produced recovery from anemia, arthritis, blood poisoning, corns, deafness, defective speech, multiple sclerosis, skin rashes, total body paralysis, visual difficulties, and various injuries. Most of these accounts contain little detail, and many of the diagnoses were made without medical consultation. Rita Swan, Ph.D., whose 16-month-old son Matthew died of meningitis in 1977 under the care of two Christian Science practitioners, quickly collected allegations of 75 deaths and 95 serious injuries to children of Chris- tian Scientists. Angered by her experience, she formed Children’s Healthcare Is a Legal Duty, Inc. (CHILD) to work for legal reforms that could protect children from inappropriate treatment by faith healers.90 She also sued the church but lost the case. During the proceedings, church officials testified that the church had no training, workshops, or meetings for practitioners that included any discussion on how to evaluate the seriousness of a child’s condition.91 A study published in 1989 compared alumni records from Principia College, a Christian Science school in Il- linois, with records from the University of Kansas. Even though Christian Science tenets forbid the use of alco- hol and tobacco, the death rates among those who had graduated from Principia between 1934 and 1948 were higher than those of their university counterparts (26.2% vs. 20.9% in men, and 11.3% vs. 9.9% in women).92 A subsequent study comparing Christian Scientists and Seventh-day Adventists (who also are admonished to abstain from cigarettes and alcohol but use scientifically oriented medical care) found even greater differences in the death rates.93 Christian Scientists can legally practice in all states. Medicare and some insurance companies cover care given by Christian Science practitioners, and their ser- vices are also tax-deductible as a medical expense for federal income-tax purposes. In 1996 a federal court judge ruled that Medicare and Medicaid payments for Christian Science nursing violate the Constitutional principle of church-state separation. The ruling came in response to a suit by CHILD and two individuals. When the suit was filed, CHILD noted in a news release that these nurses are neither licensed nor trained in science- based nursing. The release also stated: Christian Science nurses cannot take a pulse, use a fever thermometer, give an enema or even a backrub. They have no
training in recognizing contagious diseases. They have been retained to attend sick children and have sat taking notes as the children suffered and died, but have not called for medi- cal care nor recommended that parents obtain it. The notes of these . . . nurses indicate that they observed children hav- ing “heavy convulsions,” vomiting repeatedly, and urinating uncontrollably. They have seen the children moaning in pain and too weak to get out of bed. They have seen their eyes roll upward and fix in a glassy stare. One Christian Science nurse force-fed a toddler as he was dying of a bowel obstruction.
Although the court ruled in CHILD’s favor, Senator Orrin Hatch (R-UT) rescued the Church by engineering passage of a law providing for Medicare payment for “religious non-medical health care.” CHILD sued under the new law but was not successful. In December 2009, the Church’s online directory listed only 20 nurses.
Intercessory Prayer Intercessory prayer—the act of praying on behalf of others—has been investigated with a few studies. The one most often cited as evidence of effectiveness was carried out in the coronary care unit at San Francisco General Hospital. The study compared 192 patients who were prayed for by Christians located outside the hospital with 201 patients who served as controls.94 The report, published in 1988, stated that the prayed-for group had fewer complications. However, the author’s tabulation was not valid because he scored interrelated compli- cations separately and therefore gave them too much weight. The average length of hospital stay, which was not subject to this type of scoring error, was identical for the treatment and control groups. A properly designed study published in 2005 found that neither masked prayer nor music, imagery, and touch (MIT) therapy significantly improved clinical outcome after elective cardiac catheterization or angioplasty. The study included 748 patients who were assigned to groups so that the effect of off-site prayer, MIT, and/or no treatment could be compared.95 Although some studies have found that churchgo- ers tend to be healthier and to live longer than non- churchgoers, church attendance itself is unlikely to be responsible for the difference.96
Psychic Surgery Most “psychic surgeons” practice in the Philippines or Brazil, but a few have toured the United States. They purport to penetrate the body with their bare hands without leaving a skin wound. “Blood” appears when the skin is “cut,” and “diseased organs” are removed from the patient’s body. However, skilled observers
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have noted that the illusion of surgery is created with sleight of hand.85 The blood is a red dye (sometimes concealed in a false thumb), and the “diseased organs” are dye-soaked animal parts or cotton wads that are palmed. The American Cancer Society has concluded that “all demonstrations to date of psychic surgery have been done by various forms of trickery” and noted that several practitioners have been prosecuted for theft and/ or practicing medicine without a license.97
Evaluation of Faith Healing Many cures attributed to faith healing are actually cases of spontaneous remission (including some in which the original diagnosis was in error), but physicians recognize that faith can affect the condition of many sick people. This is especially true in the case of psychosomatic or hysterical disorders. Such ailments can sometimes be relieved by the ministrations of a faith healer—or, for that matter, by the reassurances of a medical doctor. It has been suggested that some people with psy- chosomatic ailments that do not respond to medical care need “an inner sense of forgiveness or cleansing” that only a ritual can produce. However, Reverend Lester Kinsolving98 has pointed out that although faith heal- ers give some people a mental lift, there is psychologic danger:
Believers who are not helped may blame themselves. They may become sicker or severely depressed by such contem- plations as: “Faith always heals; I’m not healed; I’m being punished! What have I done wrong? What’s wrong with me?”
Other problems with faith healers include failure to screen out or refer people who need medical treatment, a tendency to disparage medical care, failure to keep ad- equate records, lack of objective effort to evaluate what they do, and lack of legal restraints. Asser and Swan99 compiled well-documented reports of 172 children who had died between 1975 and 1995 after their parents re- lied on religious rituals and withheld medical care. The authors concluded that with proper medical care, 140 of the children had at least a 90% chance of surviving and 18 had at least a 50% chance of survival, and all but 3 of the rest would likely have had some benefit. Dr. Louis Rose, a British psychiatrist, investigated hundreds of alleged faith-healing cures. As his interest became well known, he received communications from healers and patients throughout the world. After nearly 20 years, he concluded that he had been unsuccessful and had yet to find one “miracle cure.”100 His published analysis of 95 purported cures indicated:
• In 58 cases it was not possible to obtain medical or other records; therefore the claims remained unconfirmed.
• In 22 cases records were so much at variance with the claims that further investigation would be pointless.
• In two cases the evidence in the medical records suggested that the healer may have contributed to amelioration of an organic condition.
• In one case demonstrable organic disability was relieved or cured after the healer’s intervention.
• In three cases the individual improved but relapsed. • Four cases showed a satisfactory degree of improvement, although re-examination and comparison of medical re- cords revealed no change in the organic state.
• In four cases there was improvement when healing was received concurrently with standard medical treatment.
• One patient examined before and after treatment by the healer gained no benefit and continued to deteriorate.
Many people with chronic or incurable diseases desperately reach for help from any source. Faith heal- ers appeal to such people’s need for hope. C. Eugene Emery, Jr., a science writer for the Providence Journal, has closely examined the work of Reverend Ralph DiOrio, a Roman Catholic priest whose healing services attract thousands. In 1987 Emery attended a service and recorded the names of nine people who had been blessed and nine others who had been proclaimed cured. DiOrio’s organization provided 10 more cases that sup- posedly provided irrefutable proof of the priest’s ability to cure. During a 6-month investigation, Emery found no evidence that any of these individuals had been helped.101
AsTrologY
Astrology as applied to health and illness involves the use of a horoscope to determine the diseases and infir- mities to which one is allegedly predisposed. Celestial patterns at the time of birth are said to indicate potential illness, which may be triggered by subsequent transit of the planets over “sensitive” areas of the natal chart. “Medical astrologers” may claim, for example, that a part of the body is prone to weakness at certain times, or that particular times may be ideal for surgery or fertility planning. Some also give dietary advice. Many people believe that horoscopes provide a basis for understanding themselves and ordering their lives.102 Experiments have demonstrated that people are likely to believe that a personality sketch fits them well, even when it was not compiled with them in mind. More than 60 years ago psychologist Bertram Forer103 admin- istered a personality test to the students in one of his courses. A week later he gave each a typed personality
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sketch with the student’s name on it—the “results” of the tests. Unknown to the students, however, each one actually received an identical list of statements that Forer had copied from an astrology book:
• You have a great need for other people to like and admire you.
• You have a tendency to be critical of yourself. • You have a great deal of unused capacity which you have not turned to your advantage.
• While you have some personality weaknesses, you are generally able to compensate for them.
• Your sexual adjustment has presented problems for you. • Disciplined and self-controlled outside, you tend to be worrisome and insecure inside.
• At times you have serious doubts as to whether you have made the right decision or done the right thing.
• You prefer a certain amount of change and variety and become dissatisfied when hemmed in by restrictions and limitations.
• You pride yourself as an independent thinker and do not accept others’ statements without satisfactory proof.
• You have found it unwise to be too frank in revealing yourself to others
• Some of your aspirations tend to be pretty unrealistic. • At times you are extroverted, affable, sociable, while at other times you are introverted, wary, reserved.
• Security is one of your major goals in life.
After reading the sketch, students were asked to rate how well it revealed their basic personality characteris- tics. On a scale of 0 (poor) to 5 (perfect), 18 out of 39 rated it 4 and 16 rated it as 5. Many other investigators have confirmed and added to these findings. People’s tendency to accept vague, ambiguous, and general statements as descriptive of their unique personality is known as “the Barnum effect.”104 Named after P.T. Barnum, it applies to any form of personality assessment, including interviews, standard psychologic tests, palmistry, tarot cards, and handwriting analysis (“graphology”). French and others105 have noted:
The typical horoscope is a mix of general statements and rather more specific ones. People tend to be impressed by the specific details that appear to fit (and pay less attention to those that do not), while the general Barnum-type statements provide readily acceptable “padding.”
In the 1980s, the Committee for Skeptical Inquiry (CSI) asked all American newspapers that publish astrol- ogy columns to carry a disclaimer that, “Astrological forecasts should be read for entertainment value only. Such predictions have no reliable basis in scientific fact.” More than 60 papers did so, and a few others reported CSI’s request as a news item.
TrAnsCendenTAl MediTATion
During transcendental meditation (TM), the meditator sits comfortably with eyes closed and mentally repeats a Sanskrit word or sound (mantra) for 15 to 20 minutes twice a day. Although the teacher supposedly chooses the mantra to fit each individual, investigators have noted that people with similar sociocultural characteristics of- ten receive the same mantra. The process can be learned for an initiation fee that covers two introductory lectures, an initiation, and four small-group meetings. In 2010, the official TM Web site (www.tm.org) stated that the cost was $1500 for adults and $750 for full-time students. TM is claimed to help people think more clearly, improve their memory, recover immediately from stress- ful situations, reverse their aging process, and enjoy life more fully. Its leaders have also claimed that “stress is the basis of all illness” and that TM is “the single most effective thing you can do to improve all aspects of health and to increase inner happiness and learning ability.”106 Meditation may temporarily relieve stress—as would forms of relaxation—but the rest of these claims have no scientific basis. The TM movement was launched in India in 1955 by the Maharishi Mahesh Yogi (~1917–2008), who had studied mysticism for many years. In 1958, according to Bloomfield and others,107 the Maharishi “proclaimed the possibility of all humanity’s attaining enlightenment” and inaugurated a “World Plan” intended to encompass “every individual on earth.” Shortly thereafter he em- barked on a world tour to spread his teachings. Eric Woodrum,108 a sociologist who spent a year as a participant-observer of TM activities, has described three phases of the early TM movement. From 1959 to 1965 TM was promoted as the most important component of a program of spiritual evolution and mental detachment (nirvana). During the late 1960s the movement expanded rapidly as it won major publicity by identifying with aspects of the counterculture. Since 1970 the move- ment has emphasized alleged practical, physiologic, material, and social benefits of TM for conventional persons, with few other-worldly references. Woodrum concluded that average meditators regarded TM as a useful mental exercise and paid little or no attention to its quasi-religious belief system. Members of the in- ner movement, however, think in metaphysical terms and state that TM can transform the world. TM leaders maintain that large groups of people meditating together produce “the Maharishi Effect,” which can reduce the incidence of crime and auto accidents. Investigators have debunked this claim by checking statistics in cities where the phenomenon had allegedly occurred.
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In the mid-1970s the Maharishi began professing he could teach advanced meditators to levitate (rise and float in apparent defiance of gravity). Although thousands of people paid $3000 each for lessons, the best they could demonstrate was cross-legged “hopping” to about 1 foot above ground level. Chapter 6 contains additional information about meditation. Maharishi Ayur-Ved Ayurvedic medicine is rooted in four Sanskrit books called the Vedas—the oldest and most important scrip- tures of India, shaped sometime before 200 bce. These books attributed most disease and bad luck to demons, devils, and the influence of stars and planets. Propo- nents state that the body’s functions are regulated by three doshas, whose Sanskrit names are vata, pitta, and kapha. Vata, for example, is said to “govern all bodily functions concerning movement” and to accumulate during cold, dry, windy weather. Like the “sun signs” of astrology, these terms are used to designate body types as well as the traits that typify them. Through various combinations of vata, pitta, and kapha, 10 body types are possible. However, one’s doshas (and therefore one’s body type) can vary from hour to hour, season to season, and questionnaire to questionnaire. Like astrologic writings, ayurvedic writings contain long lists of supposed physical and mental characteristics associated with each body type. One source, for example, states that vata individuals are “usually lightly built with excellent agility” and “love excitement and change”; vata balance produces mental clarity and alertness; and vata imbalance can produce anxiety, weight loss, con- stipation, high blood pressure, arthritis, weakness, and restlessness.109
Ayurvedic proponents claim that the symptoms of disease are always related to “imbalance” of the doshas, which can be determined by feeling the patient’s wrist pulse or completing a questionnaire (Figure 8-7). Some proponents claim that the pulse can be used to detect diabetes, cancer, musculoskeletal disease, asthma, and “imbalances at early stages when there may be no other clinical signs and when mild forms of intervention may suffice.”110 “Balance” is supposedly achieved through a multitude of procedures and products, many of which are said to be specific for specific body types. Followers of the Maharishi Mahesh Yogi state that much of ayurvedic medicine was lost until he reconsti- tuted it in the early 1980s. The “revived” version has been termed Maharishi Ayurveda, Maharishi Ayur-Veda and, most recently, Maharishi Ayur-Ved. However, these names are often used interchangeably.
The full Maharishi Ayur-Ved program for “creating healthy individuals and a disease-free society” has 20 components: development of higher states of conscious- ness through advanced meditation techniques, use of primordial sounds, correction of “the mistake of the in- tellect,” strengthening of emotions, Vedic structuring of language, music therapy, enlivening of the senses, pulse diagnosis, psychophysiologic integration, neuromuscu- lar integration, neurorespiratory integration, purification (to remove “impurities due to faulty diet and behavioral patterns”), dietary measures, herbal food supplements, other herbal preparations, daily behavioral routines, prediction of future imbalances, religious ceremonies, nourishing the environment, and promoting world health and world peace. Most of these cost several hundred dol- lars, but some cost thousands and require the services of an ayurvedic practitioner. A report in the Journal of the American Medical Association stated that the ayurvedic movement’s marketing practices revealed what ap- peared to be “a widespread pattern of misinformation,
figure 8-7. Ad from Vegetarian Times magazine. For $14.95 plus a completed questionnaire, readers could learn their “body type” and which foods and herbs would help them maintain “balance.”
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deception, and manipulation of lay and scientific news media.”111
America’s most prominent spokesperson for ayurveda has been Deepak Chopra, M.D., an endocri- nologist who, in 1984, was encouraged by the Mahari- shi to learn about ayurveda. Chopra has written many books and gained considerable public exposure through appearances on major television talk shows. An article in Forbes magazine called him “the latest in a line of gurus who have prospered by blending pop science, pop psychology, and pop Hinduism.”112 He promises “perfect health” to those who—through ayurvedic methods— can harness their consciousness as a healing force. He claims that “remaining healthy is actually a conscious choice.”113 He maintains:
If you have happy thoughts, then you make happy molecules. On the other hand, if you have sad thoughts, and angry thoughts, and hostile thoughts, then you make those molecules which may depress the immune system and make you more susceptible to disease.
unsCienTifiC MediCAl prACTiCes
A small percentage of physicians are rendering diag- noses and prescribing treatments that the vast majority of physicians consider invalid. Some of these practices have just a few proponents, whereas others have several hundred. Many of these practitioners feel alienated from scientific medical practices and promote their beliefs to the public through publications, lectures, and talk show appearances. The approaches described in this section rest on faulty medical reasoning rather than a vitalistic rationale.
Fad Diagnoses Years ago many nervous or tired people were said to have adrenal insufficiency, a serious glandular disorder that is actually quite rare. The vast majority of these people were not only misdiagnosed but were also treated with adrenal gland extract, a potentially harmful substance they did not need. Today a diagnosis of hypoglycemia (low blood sugar) is sometimes used to explain similar symptoms. Doctors who are true believers in hypogly- cemia are apt to diagnose it in large numbers of their patients. However, it is actually quite rare and should be diagnosed only after careful interpretation of blood glucose tests. A diagnosis of functional hypoglycemia should not be considered unless a person who consumes a balanced diet gets symptoms 2 to 4 hours after eating, develops blood glucose levels below 45 mg per 100 ml whenever symptoms occur, and is immediately relieved
of symptoms when the blood glucose level is raised. Bennion114 cautioned that the commonly performed glucose tolerance test is not reliable for evaluating most cases of suspected hypoglycemia. Low blood glucose levels without symptoms occur commonly in normal persons fed large amounts of sugar. These incidents have no diagnostic significance. Clinical ecology is based on the notion that multiple symptoms are triggered by hypersensitivity to common foods and chemicals. Advocates of this belief system describe themselves as “ecologically oriented” and con- sider their patients to be suffering from “environmental illness,” “multiple chemical sensitivity (MCS),” “allergy to everything,” or “twentieth-century disease,” which can mimic almost any other illness. Clinical ecologists speculate that (a) although various substances alone may not cause trouble, low doses of different substances can increase each other’s effects; (b) hypersensitivity de- velops when the total load of physical and psychologic stresses exceeds a person’s tolerance; and (c) hypersen- sitivities may be due to “immune system dysregulation” that can be difficult to diagnose and treat.115
According to proponents, potential stressors include practically everything that modern humans encounter, such as urban air, diesel exhaust, tobacco smoke, fresh paint or tar, organic solvents and pesticides, certain plastics, newsprint, perfumes and colognes, medications, gas used for cooking and heating, building materials,
Figure 8-8. Some “MCS” patients wear a mask to filter the air they breathe when away from home.
©Rob Kendrick/AURORA
Chapter Eight The “CAM” Movement 155
permanent press and synthetic fabrics, household clean- ers, rubbing alcohol, felt-tip pens, cedar closets, tap water, and electromagnetic forces (Figure 8-8). The signs and symptoms are said to include depression, irritability, mood swings, inability to concentrate or think clearly, poor memory, fatigue, drowsiness, diarrhea, constipa- tion, sneezing, runny or stuffy nose, wheezing, itching of the eyes and nose, skin rashes, headaches, muscle and joint pains, frequent urination, pounding heart, swelling of various parts of the body, and even schizophrenia. To diagnose “ecologically related” disease, prac- titioners take a history that emphasizes dietary habits and exposure to environmental chemicals they consider harmful. Various nonstandard tests and elimination and rotation diets are used with the hope of identifying foods that cause problems. In severe cases, patients may spend several weeks in an environmental control unit designed to remove them from exposure to airborne pollutants and synthetic substances that might cause adverse reactions. Generally patients are instructed to modify their diet and to avoid substances such as scented shampoos, after- shave products, deodorants, cigarette smoke, automobile exhaust fumes, and synthetic fibers contained in clothing, furniture, and carpets. Extreme restrictions can include staying at home for months and avoiding physical contact with family members. “Ecologically ill” patients may think of themselves as immunologically disabled in a hostile world of dangerous foods and chemicals and an uncaring medical community. In many cases their life becomes centered around their illness. The American Academy of Allergy, Asthma, & Im- munology (AAAAI),116 the nation’s largest professional organization of allergists, has warned:
Although the idea that the environment is responsible for a multitude of health problems is very appealing, to present such ideas as facts, conclusions, or even likely mechanisms without adequate support, is poor medical practice.
Clinical ecologists base their diagnoses primarily on the results of “provocation” and “neutralization” tests, which are performed by having the patient report symptoms that occur within 10 minutes after suspected harmful substances are placed under the tongue or in- jected into the skin. If any symptoms occur, the test is considered positive, and lower concentrations are given until a dose is found that “neutralizes” the symptoms. Double-blind testing has demonstrated that these proce- dures are not valid. Eighteen patients each received three injections of suspected food extracts and nine injections of normal saline over a 3-hour period. The tests were con- ducted in the offices of proponents who had been treating them. In unblinded tests these patients had consistently
reported symptoms when exposed to food extracts and no symptoms when given saline injections. But during the experiment they reported as many symptoms following saline injections as they did after food extract injections, indicating that their symptoms were nothing more than placebo reactions. “Neutralizing” doses were equally effective whether they were food extracts or saline. The symptoms included nasal stuffiness, dry mouth, nausea, fatigue, headaches, and feelings of disorientation or depression.117
William J. Rea, M.D., who operates the Environ- mental Health Center in Dallas, Texas, has for many years been the leading MCS proponent. In 2007, the Medical Board of Texas charged him with (a) using pseudoscientific test methods, (b) failing to make accu- rate diagnoses, (c) providing “nonsensical” treatments, (d) failing to properly inform patients that his approach is unproven; (e) practicing in areas for which he has not been trained, and (f) representing himself certified by a board that is not recognized by the American Board of Medical Specialties. The complaint was settled in 2010 with an agreed order under which Rea must inform
Personal Glimpse
Recipe for a New Fad Disease
• Pick any symptoms—the more common the better. • Pick any disease—real or invented. (Real diseases have more potential for confusion because their existence can’t be denied.)
• Assign lots of symptoms to the disease. • Say that millions of undiagnosed people suffer from it.
• Conduct tests that support your diagnosis—either standard tests that you misinterpret, or nonstandard tests done by cooperating laboratories.
• Pick a few treatments. Suggesting supplements will enable retailers as well as practitioners to get in on the action.
• Promote your theories through books, talk shows, and Web sites.
• Don’t compete with other fad diseases. Say that yours predisposes people to the rest or vice versa.
• Claim that the medical establishment, the drug companies, and the chemical industry are against you.
• State that the medical profession is afraid of your competition or trying to protect its turf.
• If challenged to prove your claims, say that you lack the money for research, that you are too busy getting sick people well, and that your clinical results speak for themselves.
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patients that various preparations he injects (such as exhaust fume solutions) contain no detectable amounts of “active” ingredients. As part of the settlement, the charges unrelated to informed consent were dropped.118
“Candidiasis hypersensitivity” is an alleged condi- tion with multiple symptoms that may include fatigue, depression, inability to concentrate, hyperactivity, headaches, skin problems (including hives), abdominal pains and bloating, constipation, diarrhea, respiratory symptoms, and problems of the urinary and reproductive organs. Its leading proponent, William G. Crook, M.D. (1917–2002), claimed that if a careful checkup does not reveal a cause for such symptoms and a medical history includes antibiotic usage, “it’s possible or even probable that your health problems are yeast-connected.”119
The proposed treatment program includes food supplements, special diets, and treatment with antifungal drugs. Proponents claim that the diagnosis is confirmed if the patient improves after taking antifungal drugs. However, AAAAI regards the concept of “candidiasis hypersensitivity” as “speculative and unproven,” and notes that everyone has some of its supposed symptoms from time to time. In a strongly worded position paper AAAAI has warned that some patients who take the inappropriately prescribed antifungal drugs will suffer side effects and that overuse of these drugs could lead to the development of resistant germs that endanger everyone.116 In 1990 a double-blind trial found that the antifungal drug nystatin was no better than a placebo for relieving systemic or psychologic symptoms attributed to “candidiasis hypersensitivity syndrome.”120 Many physicians accustomed to rendering the aforementioned “fad diagnoses” have added “chronic fatigue syndrome” (CFS) to their list. This is a contro- versial diagnosis that may be appropriate only for a small percentage of people who experience chronic fatigue. Because no cause has been discovered, some doctors wonder whether CFS actually is a disease. According to criteria developed by the U.S. Centers for Disease Control and Prevention, the diagnosis should not be made unless unexplained severe fatigue persists or recurs for at least 6 months and is accompanied by at least four of the following: (a) impaired memory or concentration, (b) sore throat, (c) tender lymph nodes in the neck or armpits, (d) muscle pain, (e) pain in several joints, (f) new headaches, (g) unrefreshing sleep, and (h) malaise after exertion.121 Other likely causes of fatigue must be carefully ruled out. Testing for antibodies to the Epstein-Barr virus (the causative agent of mono- nucleosis) is not useful for evaluating severe fatigue because 80% of healthy adults have positive antibody
tests, presumably from mild or inapparent infection at an earlier age. No treatment has been proven effective for CFS, although antidepressant drugs may help relieve certain symptoms. Consumer Reports122 has advised conservative measures: a balanced diet, adequate sleep, avoidance of excess stress, gradually increasing exercise without overdoing it, and—above all—patience. Calling CFS “a magnet for quacks,” the magazine warned that “some practitioners create CFS patients by finding the syndrome in people who clearly don’t have it.” Another popular diagnosis among supplement pro- moters is “parasites,” which may be “treated” with laxa- tives and other “intestinal cleansers,” colonic irrigation, plant enzymes, dietary measures, and homeopathic rem- edies. Yet another, “leaky gut syndrome,” is described by proponents as a condition in which the intestinal lining becomes irritated and porous so that unwanted food particles, “toxins,” bacteria, parasites, and “Can- dida” enter the bloodstream and result in “a weakened immune system, digestive disorders, and eventually chronic and autoimmune disease.” Treatment of this al- leged condition can include dietary changes (such as not eating protein and starch at the same meal); “cleansing” with herbal products; “reestablishing good balance” of intestinal bacteria; and supplement concoctions claimed to strengthen and repair the intestinal lining.123 Lyme disease is also being overdiagnosed. The actual disease is a spirochetal infection acquired through a tick bite and is easily curable with antibiot- ics. However, some doctors are applying this diagnosis to patients with chronic nonspecific symptoms, such as headaches, fatigue, achiness, mental confusion, or sleep disturbances. The recommended treatment may include antibiotic therapy for many months, hyperbaric oxygen, colloidal silver, dietary supplements, and/or herbs, none of which have any proven value for such symptoms.124 The Infectious Diseases Society of America125 warns that long-term antibiotic treatment is unwarranted and potentially dangerous.
Chelation Therapy Chelation therapy involves a series of pills, intravenous infusions, or intramuscular injections of drugs that in- crease the excretion of heavy metals. The infusions typi- cally include various vitamins and minerals. Chelation therapy is claimed to be effective against kidney and heart disease, arthritis, autism, Parkinson’s disease, emphysema, multiple sclerosis, gangrene, psoriasis, and many other serious conditions. However, no controlled trial has shown that it can help any of them.126 A course
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applied in the assessment and treatment of patients in whom there is concern for metal poisoning.” In 2002, Knudson and colleagues130 at the University of Calgary found that cardiac patients receiving chela- tion therapy fared no better than those who received placebo treatment. The patients were randomly assigned to get intravenous infusions twice weekly for 15 weeks and monthly treatments for 12 more weeks. Thirty-nine patients in each group completed the 27-week protocol and were followed-up for about 6 more months. The chelation and placebo groups showed no difference in exercise capacity or feelings of well-being, but both groups increased their ability to walk on a treadmill by an average of one minute. The experiment shows why it would be improper to judge the results of chelation therapy outside of an experimental protocol. In 2004, the National Center for Complementary and Alternative Medicine launched a large study of chelation therapy for cardiovascular disease. Critics believe that the study is unethical and a waste of scarce research dollars because the procedure lacks a plausible rationale.131 Inspired by the claims for chelation therapy, many entrepreneurs have marketed a multitude of vitamin and homeopathic concoctions falsely said to do the same thing as chelation therapy when they are taken by mouth. The FDA has stopped some manufacturers from marketing these products, but others are still doing so. Some falsely portray atherosclerosis as a simple buildup of fatty-cholesterol sludge that their products dissolve. As Chapter 15 explains, the buildup includes fibrous tissue that is not easily removed.
of intravenous treatment, consisting of 20 to 50 infu- sions, costs thousands of dollars. Chelation therapy for the conditions just listed is not covered by Medicare or most other insurance policies. Chelation therapy with calcium EDTA is one of several legitimate methods for treating cases of lead or other heavy metal poisoning, but the protocol differs from the one just described. Some chelation therapists submit fraudulent insurance reports using a procedure code for standard infusion therapy or claiming that they treated heavy metal poisoning. Chelation therapy is heavily promoted as an al- ternative to coronary bypass surgery. It is sometimes claimed to be a “chemical Roto-Rooter” that can clean out atherosclerotic plaque from the body’s arteries. It is not. In 1999, the Federal Trade Commission obtained a consent decree barring the leading chelation therapy organization from advertising that chelation is effective against cardiovascular disease or any other disease of the circulatory system.127 The decree does not apply to individual physicians, who are regulated by state boards. Figure 8-9 is from an ad by a Pennslyvania physician. Many chelation therapists tell patients their body has toxic levels of heavy metals. To help persuade them of this, they administer a chelating agent and ask the patient to submit a 6-hour urine specimen for a “urine toxic metals test.” Chelating agents artificially raise the urine excretion levels of mercury, lead and other heavy metals, which the laboratory and/or the doctor then misrepresent as dangerous.128 The American Col- lege of Medical Toxicology (ACMT)129 has warned that provoked testing “has not been scientifically validated, has no demonstrated benefit, and may be harmful when
Figure 8-9. Excerpt from a 1996 flyer from an osteopathic physician whose radio advertisements invited people who had been advised to have coronary bypass surgery to consult him first. There is no published scientific evidence that chelation therapy can render bypass surgery unnecessary or can help people with any of the conditions listed in the ad. The experience to which the ad refers is not a trustworthy substitute for scientific testing.
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supporTive orgAnizATions
“Alternative” practitioners tend to be politically and emotionally supportive of one another, and many have banded together in professional groups. Some of these are limited to physicians, some accept all types of health- care providers, and some admit laypersons as well. Some of the professional groups publish a journal and operate a “specialty board” that certifies practitioners but lacks standing within the scientific community. Some groups are campaigning for laws to prevent state licensing boards from disciplining their members for us- ing unscientific practices. Some also have an associated charitable foundation. The professional groups include the American Holis- tic Medical Association (600), American College of Ad- vancement in Medicine (500), International College of Integrative Medicine (200), Society of Orthomolecular Health Medicine (400), American Academy of En- vironmental Medicine (500), American Academy of Otolaryngic Allergy, Holistic Dental Association (130), American Holistic Nurses Association (5000), and American Holistic Veterinary Medical Association (750). The numbers in parentheses are approximate number of members listed in their online directories. The largest advocacy organization is the Alliance for Natural Health USA (formerly the American Association for Health Freedom), which has tens of thousands of lay and professional members. Its mission is to “protect the right of natural health practitioners to practice, and the right of consumers to choose the healthcare options and treatment modalities they prefer, including complemen- tary and alternative medicine.” Consumers Union has recommended that state licensing boards systematically evaluate the work of medical and osteopathic physicians who engage in megavitamin therapy, clinical ecology, chelation therapy, homeopathy, or other unscientific methods, to determine whether they are qualified to remain in practice.132
“MediCAl freedoM” lAws
During the past century, as scientific health care ad- vanced, many laws were passed to protect the public from methods that are ineffective or promoted with misinformation. “Alternative” advocates are campaign- ing to weaken or overturn these laws. Within the past few years, several states have passed “Medical Freedom of Choice” bills. These prevent or make it difficult for their licensing boards to discipline practitioners who use a nonstandard treatment that does not directly threaten the life or health of the patient.133 A federal “Access to Medical Treatment Act” has been introduced to prevent the FDA from interfering with the sale and distribution of unproven drugs and devices. Proponents claim that these types of laws increase individual freedom without increasing consumer risk. This is untrue. The basic principle of our health-related consumer-protection laws is that products cannot be marketed until proven safe and effective by scientific testing. Doctors who wish to test a new product can obtain FDA permission by showing reasonable prelimi- nary evidence of safety and potential usefulness. This policy is not oppressive; it simply requires these doc- tors to act in a responsible manner. “Medical freedom” laws facilitate the sale of worthless treatments, permit marketing of products whose safety has not been tested, and make it difficult to prevent unscientific practitioners from exploiting patients.
The nih CenTer for CoMpleMenTArY And AlTernATive MediCine (nCCAM) Many special interests have a stake in promoting the notion that it is meaningful to speak of CAM as if it is a field of health care. In 1991, at the urging of a former congressman who had used “alternative” therapies after undergoing con- ventional treatment for Lyme disease and prostate cancer, Senator Tom Harkin (D-IA) spearheaded passage of a law ordering the National Institutes of Health (NIH) to foster research into unconventional practices. To carry out the law’s intent, the NIH established an office of unconventional medicine, which was later renamed the Office of Alternative Medicine (OAM). From 1992 to 1998, the OAM’s budget increased gradually from $2 million to $19.5 million. In 1998, Congress transformed OAM into NCCAM, giving it more independence and funding that rose steadily from $49 million in 1999 to $129 million in 2010. None of this money has been used to identify or oppose quackery promoted as “CAM.” The NCCAM Web site has never
One of your male relatives has recurrent chest pains (angina) due to impaired coronary artery circulation. After having an angiogram, he was advised to have bypass surgery. A local chelation therapist advertises that people advised to have coronary bypass surgery should see him instead. Your relative has scheduled an appointment to see the chelationist. What should you do?
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said that any “CAM” method is so implausible that it should be discarded. “CAM” proponents have trumpeted the involvement of NIH as evidence that whatever they espouse is valid. Its main impact so far has been as a magnet for the press. The resultant press reports have contained little criticism and featured the views of proponents and their satisfied patients. Few reporters make any effort to determine whether the “alternative” or “complementary” methods they mention are useful, promising, or nonsensical. Even physicians and medical students are exposed to a steady flow of misleading “CAM” promotion through journals whose editors don’t understand how “CAM” proponents misrepresent what they do. In 2000, the White House appointed a Presidential Commission on CAM to make recommendations for further study. Nearly all of the commissioners are philo- sophically aligned and economically involved with the so-called “CAM” movement. Few knowledgeable critics were appointed. The commission’s final report recom- mended across-the-board “integration” of “CAM” into government health agencies, the nation’s medical sys- tem, medical education, and insurance systems.134,135 To some extent, that has already happened, but not because “CAM” methods are effective. Largely for economic
reasons, many medical centers have opened NCCAM- funded research centers and “integrated” medical clinics. Potential critics of these facilities tend to remain quiet for fear that they will offend colleagues or be branded as intolerant or closed-minded. In 2005, the Institute of Medicine (IOM) issued a similar “CAM” report,137 to which Dr. Stephen Barrett138 responded:
• The report was assembled by a committee dominated by “CAM” practitioners and ideologues, at least half of whom had an economic connection with the subject matter.
• Knowledgeable critics were not permitted to present meaningful testimony to the committee or participate in prepublication review of the report.
• The report made sweeping generalizations and attempts to set an agenda for widespread adoption of “CAM” research and teaching. Neither is justified. Nor is there any reason to believe that the teaching envisioned by the committee will provide science-based information to its recipients.
• If the report’s research recommendations were carried out, the biggest winner is likely to be the NCCAM, which funded the report and helped ensure that its conclusions were precisely what it wanted.
The most detailed and scholarly investigation of “CAM” research was conducted by R. Barker Bausell, Ph.D., who served for five years as research director of the University of Maryland’s NIH-funded Comple- mentary Medicine Program (now called the Center for Integrated Medicine). Bausell139 concluded:
No CAM therapy has a scientifically plausible biochemical mechanism of action over and above those proposed for the placebo effect. Of course, just because there is no rational explanation for why something should benefit a medical condition or reduce a medical symptom doesn’t mean that this something can’t do so. Unfortunately, the results from high- quality, randomized, placebo-controlled trials and systematic reviews have demonstrated that CAM therapies don’t do so, which regretfully leads me to conclude that CAM therapies are nothing more than cleverly packaged placebos. And that is almost all there is to say about the science of CAM.
suMMArY
“CAM” practitioners espouse a wide variety of theories and methods not based on scientific evidence. Some of these practitioners seem sincere in their beliefs, whereas others are clear-cut frauds. In some cases they mix ef- fective methods with ineffective ones. In some cases their methods may relieve symptoms related to ten- sion. In many cases they claim credit for spontaneous improvements. Some “CAM” practitioners know their limitations; others will attempt to treat any ailment.
Why NCCAM Should Be Defunded Ill-conceived research produces misleading results. The results then lead to repetitive cycles of unproduc- tive work to explain what was found, usually just to disprove the erroneous results. As a result of all this, claims continue. . . . Special commercial interests and irrational, wishful thinking created NCCAM. It is the only entity in the NIH devoted to an ideological approach to health. To correct the situation, Congress must con- sider at least interrupting funding of NCCAM while results of work in progress mature. NCCAM could be dissolved, its functions returned to other NIH centers, with no loss of knowledge, and an economic gain. Funds could be invested into studies of how such misadventures into “alternative” medicine can be avoided, and on studying the warping of human perceptions and beliefs that led to the present situa- tion. More public money for investigating methods with negligible promise is foolish economics and even more, is unwise public policy.
Wallace I. Sampson, M.D.136
Personal Glimpse
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The vast majority make no effort to test the validity of what they do. The National Center for Complementary and Alternative Medicine was established through the influence of political insiders rather than any scientific merits of “alternative medicine.” It has produced little useful research and endangered medical education by funding “CAM” centers in medical schools. Consumers should be wary of the approaches de- scribed in this chapter and use them cautiously, if at all. Current consumer-protection laws need strengthening rather than weakening.
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• Pseudoscientific (based on theories and methods misrepresented as scientific)
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67. Pizzorno JE Jr, Murray MT. Encyclopedia of Natural Medicine, ed 2. Rocklin, Calif., 1998, Prima Publishing & Communica- tions.
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69. Cohen W. Independent Practitioners under Medicare. A Report to Congress. Washington, D.C., 1968, U.S. Department of Health, Education, and Welfare.
70. Raso J. Natural hygiene: Still alive and dangerous. Nutrition Forum 7:33–36, 1990.
71. Jensen B. Iridology simplified. Escondido, Calif., 1980, Iridolo- gists International.
72. Simon A and others. An evaluation of iridology. JAMA 242:1385–1387, 1979.
73. Knipschild P. Looking for gall bladder disease in the patient’s iris. British Medical Journal 297:1578–1581, 1988.
74. Worrall RS. Iridology: Diagnosis or delusion? Skeptical Inquirer 7(3):23–35, 1983.
75. Barrett S. Reflexology: A close look. Quackwatch Web site, Sept 25, 2004.
76. Hartman SE, Norton JM. Interexaminer reliability and cranial osteopathy. Scientific Review of Alternative Medicine 6(1):23- 34, 2002.
77. Barrett S. Aromatherapy: Making dollars out of scents. Quackwatch Web site, Aug 27, 2001.
78. Rosa L and others. A close look at therapeutic touch. JAMA 279:1005–1010, 1998.
79. Lee MS and others. Effects of reiki in clinical practice: A systematic review of randomized clinical trials. International Journal of Clinical Practice 62:947-954, 2008.
80. Randi J. Flim-flam! Psychics, ESP, Unicorns and Other Delu- sions. Amherst N.Y., 1982, Prometheus Books.
81. Massage therapy: Enhancing your health with therapeutic massage (brochure). Evanston, Ill, 1999, American Massage Therapy Association.
82. Barrett S. Massage therapy: Riddled with quackery. Quackwatch Web site, March 9, 2006.
83. Jarvis W. Faith healing: Taming the therapeutic miracle. Un- published manuscript, 1977.
84. Barnes BM and others. Complementary and alternative medicine use among adults: United States, 2002, Advanced Data, May 27, 2004.
85. Nolen W. Healing: A Doctor in Search of a Miracle. New York, 1974, Random House Inc.
86. Randi J. The Faith Healers. Amherst, N.Y., 1987, Prometheus Books.
87. Memorandum opinion and order. USA v. Walter V. Grant. US District Court for the Northern District of Texas, Dallas Divi- sion, Case No. 3:96-cr-00127, July 26, 1996.
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90. Swan R. Faith healing, Christian Science, and the medical care of children. New England Journal of Medicine 309:1639–1641, 1983.
91. Swan R, Swan D. Civil suits against Christian Science providers; no standards established. CHILD Newsletter, No 1, 1991.
92. Simpson WF. Comparative longevity in a college cohort of Christian Scientists. JAMA 262:1657–1658, 1989.
93. Comparative mortality of two college groups. CDC Mortality and Morbidity Weekly Report 40:579–582, 1991.
94. Byrd RC. Positive therapeutic effects of intercessory prayer in a coronary care unit population. Southern Medical Journal 81:826–829, 1988.
95. Krucoff MW and others. Music, imagery, touch, and prayer as adjuncts to interventional cardiac care: The Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study. Lancet 366:211-217, 2005.
96. Sloan RP, Bagiella E, Powell T. Religion, spirituality and medi- cine. Lancet 353:664–667, 1999.
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109. Chopra D. Growing younger: A practical guide to lifelong youth. Alexandria, Va., 1994, Time Life Video.
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A Close look At ChiroprACtiC
Chiropractic is the greatest tribute to the efficacy of technically applied public rela- tions the world has ever known. These people have been delivering a package since 1895, the sale of which depends entirely on the wrapping. The contents are not there.
Joseph A. sAbAtier, Jr., M.D.1
Chapter Nine
Chiropractors seldom react constructively to criticism. When specific wrongdoings are exposed, they typically claim that the criticized practices are not representative or that the critic is biased. . . . or they attack the medical profession.
stephen bArrett, M.D.3
Every action the chiropractor does should have the one purpose to slowly but surely direct the patient’s attention to the fact that chiropractic is capable of correcting the ‘condition’ that is ‘causing’ the patient’s ill health.
siD e. WilliAMs, D.C.2
“As you can see, for nearly all chiropractors there are equal and opposite chiropractors.”
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• Chiropractic’s “subluxation” concept lacks anatomic and clinical validity. The “nerve interference” that chiropractors postulate has not been scientifically demonstrated. Reliance on these concepts places patients at significant risk.
• Chiropractic has not defined its scope.
• Most methods that chiropractors use are unproven and lack a scientifically plausible rationale.
• Chiropractic “maintenance” care has not been substantiated or even tested.
• Research studies on spinal manipulation may not reflect how patients are managed in chiropractic offices.
• Chiropractic’s recognition as a profession is the result of political efforts rather than scientific achievement.
keep these points in Mind As You studY this ChApter
Key Concepts
Chiropractic is a wide array of practices with em- phasis on spinal “adjustments.” Chiropractic the- ory claims that (a) spinal misalignments, which
chiropractors refer to as subluxations, impair health by interfering with the integrity of the nervous system and (b) spinal adjustments restore the integrity of the nervous system, enable the body’s inherent recuperative power to restore health, and thereby prevent or remedy a wide range of health problems. Chiropractors may help people with certain musculoskeletal ailments, but the problems described in this chapter are widespread and, in some cases, integral to chiropractic philosophy and practice. Thus, even though some of the source materials and opinions cited in this chapter originated long ago, they remain relevant to the current marketplace.
historiCAl perspeCtive
Various forms of spinal manipulation have been noted throughout recorded history.4 The “discovery” of chiro- practic was announced in 1895 by Daniel David (“D.D.”) Palmer, a grocer, spiritualist, and “magnetic healer” who practiced in Davenport, Iowa. Palmer believed that he had restored the hearing of a deaf janitor by “adjusting” a hump on his spine. Even though the nerve that con- trols hearing is inside the skull and does not traverse the spine, Palmer concluded that the basic cause of disease was nerve interference caused by displaced vertebrae.5 He originally declared that such misalignments cause abnormal tension (“tone”) in the nearby nerves and that disturbed nerve tone causes 95% of all diseases. Later he elaborated a vitalistic doctrine which held that (a) “In- nate Intelligence,” or “nerve energy,” flows throughout the nervous system and controls every bodily activity not under voluntary control; (b) even slight spinal mis- alignments hinder this flow, causing people to become ill; and (c) manual manipulation (“adjustment”) of the
spine is the remedy. He rejected the germ theory and had an aversion to drugs, surgery, and medical diagnosis. Palmer referred to spinal “misalignments” as “luxa- tions.” A few years later a disciple began calling them “subluxations,” a term that became central to chiroprac- tic theory and is still used today. The word “chiropractic” was derived from the Greek words cheir (hand) and praktikos (practice). Soon after his “discovery,” Palmer opened a school to teach his methods to others. The basic entrance re- quirement, as it was in many medical schools around the turn of the century, was the ability to pay tuition.6 One of the first students was Palmer’s son, Bartlett Joshua (“B.J.”), who became chiropractic’s developer. In 1906 D.D. Palmer was convicted of practicing medicine with- out a license and spent 23 days in jail. After his release, B.J. denied him access to the school grounds and wound up purchasing D.D.’s interest in the Palmer School of Chiropractic. At that time about 100 chiropractors were practicing in the United States. Today there are about 65,000. Between 1913 and 1933, 40 states passed laws to license chiropractors; the remaining states gradually fol- lowed suit, with Louisiana being the last in 1974. Chiro- practors have lobbied successfully in most states for laws that force insurance companies to pay for some of their services. In 1972 Congress legislated coverage under Medicare for “treatment by means of manual manipula- tion of the spine to correct a subluxation demonstrated by x-rays to exist.” The International Chiropractors Association states that passage of this bill was spurred by more than 10 million letters received by members of Congress.7 The x-ray requirement was eliminated in 2000. U.S. Census Bureau data indicate that the total re- ported income for chiropractic offices and clinics rose from $6.57 billion in 1997 to $10.06 billion in 2007s.8
Chapter Nine A Close Look at Chiropractic 165
ChiroprACtiC philosophY
Chiropractic’s uniqueness is not in its use of manipu- lation but in its theoretical basis for doing so. Jarvis9 describes chiropractic as “a conglomeration of factions in conflict, bound together only by opposition to outside critics.” Philosophy and treatment methods vary greatly from one chiropractor to another, but there are two main types: “straights” and “mixers.” Straights tend to regard “subluxations” as the primary cause of ill health and spinal “adjustments” as the remedy. Some routinely manipulate the neck for complaints in all parts of the body. Many straights disparage medical diagnosis, some even claiming that their sole responsibility is to examine and adjust the spine. Mixers, who are more numerous, acknowledge that germs, hormones, and other factors play a role in disease; however, they tend to regard mechanical disturbances of the nervous system as the underlying cause (through lowered resistance). In ad- dition to spinal manipulation, they may use measures that are standard in physical therapy as well as a wide spectrum of questionable nonmedical approaches. Mix- ers are more likely to diagnose medical conditions in addition to spinal abnormalities and to refer patients to medical practitioners for treatment. Figure 9-1 illustrates chiropractic’s tendency to overclaim. Both straights and mixers may claim that the nervous system is the master of all body functions, regulating everything from major organs to intricate cellular activi- ties. This statement is untrue. However, charts and other materials relating the spine to the full range of illnesses can still be found in many chiropractic offices and online (Figure 9-2). Thus, even though nearly all chiropractors manipulate the spine as their primary treatment method, their rationales and techniques vary considerably. Many chiropractors detect “subluxations” in healthy individuals. A small percentage of chiropractors reject
the subluxation concept and limit their practice to short- term treatment of musculoskeletal conditions using evidence-based procedures similar to those of physical therapists and osteopaths. Chiropractors also differ greatly about how treatment should be done. More than 200 “technique systems” have been advocated. In 1996, Thomas F. Bergmann, D.C., who edited the journal Chiropractic Technique, stated:
A challenge for the future is to classify and place all chiroprac- tic techniques into a framework that allows determination as to whether any of them has a basis in fact. . . . Studies designed to compare effectiveness . . . have not been done. . . . No technique system has been demonstrated to be more or less effective than any other for any condition.10
In 2011, Bergmann acknowledged that chiropractic research had not yet solved any these problems.11
Figure 9-2. Chart from a chiropractic brochure. Many chiropractors use such charts to reinforce the idea that spinal problems are a major cause of disease. This one claims that “spinal misalignments” can cause more than 100 health problems, including allergies, amnesia, crossed eyes, deafness, gallbladder conditions, hernias, jaundice, and pneumonia. Other charts showing how nerves connect from the spine to the body’s organs are used to persuade patients that regular spinal care is essential for good health.
Figure 9-1. Portion of a chiropractic newspaper ad from the 1970s that illustrates chiropractic’s tendency to overclaim.
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The two largest chiropractic organizations are the American Chiropractic Association (ACA, mixers) and the International Chiropractors Association (ICA, straights). Judging from their income tax returns and dues structures, the ACA appears to have about 8000 members (not including students) and the ICA has about 2500. The two groups have considered merging, but they are unable to agree on the definition and scope of chiropractic. The World Chiropractic Alliance, which has about 900 members, states that its mission is “promoting a subluxation-free world.” A small network of faculty members at some of the chiropractic colleges is attempting to place chiropractic on a scientific basis by determining which practices are valid and which are not. In 1995, Magner12 noted that negative research findings appeared to have little effect on what most chiropractors do. That is still true today.
The Elusive “Subluxation” Medical doctors and chiropractors use the word “sublux- ation” differently. The medical meaning is incomplete or partial dislocation—a condition, visible on x-ray films, in which the bony surfaces of a joint no longer face each other exactly but remain partially aligned. Most partial dislocations occur in areas other than the spine and are the result of injury. Spondylolisthesis, a partial dislocation of a spinal bone, usually is congenital and causes no symptoms. Because the ligaments connecting the spinal bones are quite strong, vertebral dislocations rarely occur after birth and are unlikely without severe injury that would require surgical treatment, not chiro- practic treatment.
Chiropractors disagree on how their “subluxations” should be defined. Some describe them as “bones out of place” and/or “pinched nerves,” some speak of “fixations” and/or loss of joint mobility, some occupy a middle ground that includes any or all of these ideas, and a few renounce chiropractic’s subluxation concepts completely. Figure 9-3 shows a children’s storybook used to promote the notion that correcting subluxations promotes general health. Figure 9-4 shows a poster that has been used for more than 20 years to suggest that chiropractic care is necessary. Chiropractors also disagree on whether their “sub- luxations” are visible on x-ray films. Those who claim that “nerve interference” results in too much or not enough “nerve energy” have never specified how this could be measured by scientific instruments. Chiropractors also differ among themselves about whether specific patients have subluxations and what to do about them. Several investigations in which many chiropractors have examined the same patient have found that the diagnoses and proposed treatments differed greatly from one practitioner to another. The Personal Glimpse Box on the next page includes the results of five such investigations. Some physical therapists, athletic trainers, osteo- pathic physicians, and medical doctors use manipulative
Figure 9-3. Chiropractic story- book. After a chiropractor told a little girl that she had a sub- luxation, she searched in vain under her bed and in her toybox to find it. She finally learned its location when the chiropractor said it was a bone in her neck that was “not lined up with the other ones.” The chiropractor explained: “Subluxations make your body sick. Each time I push on your back, the bones are adjusted closer to their normal position. This opens up the pathways, so that your brain may talk properly with your body. As your subluxations are corrected, you become healthier.” The booklet was marketed by a practice-building firm that promoted “chiropractic pediatrics.”
Figure 9-4. Poster for chiropractic offices. A distributor calls it “the most powerful single visual aid available.”
Chapter Nine A Close Look at Chiropractic 167
s Personal Glimpse
pinched nerve in the boy’s neck. Another said his left leg was shorter than his right. Another said his right leg was shorter than his left. Another diagnosed zinc deficiency. Another chi- ropractor blamed the boy’s ear problems on “food sensitivi- ties” and advised avoiding corn, cow’s milk, and white flour. Another gave similar dietary advice but said that the main diagnosis was a “subluxation” in the top vertebra. Another said the boy didn’t have an ear problem but had scoliosis—a diagnosis disputed by a pediatrician and a radiologist who reviewed this chiropractor’s findings. In 2001, a healthy 11-year-old girl was taken by her uncle (a reporter) to five chiropractors in Toronto, Canada, for a checkup. The chiropractors were told the child was gener- ally in good health but suffered from a few earaches, some mild headaches, and a few signs of allergy symptoms. The chiropractors were also told that the girl’s mother was worried about the possibility of asthma and had heard from neighbors that chiropractic care could be beneficial for children. Four of the chiropractors found different subluxations and said that the girl needed chiropractic adjustments to get healthy. The methods they used to locate the alleged subluxations included spinal palpation, thermographic scans (looking for heat differences), and surface electromyography (SEMG), which merely measures muscle electrical activity. Among other things, the chiropractors said the child had one shoulder lower than the other, one leg longer than the other, one hip higher than the other, one ear lower than the other, something called “anterior head carriage,” scoliosis, early osteoarthritis, and numerous subluxations, all of which could cause earaches, headaches, allergies, asthma, arthritis, learning problems, and more serious problems later in life, including digestive and reproductive problems. In 2004 a team of high school students contacted chiro- practic offices in metropolitan Portland, Oregon, and found evidence of unscientific practice in every one. Following a script, they posed as a prospective patient and telephoned 42 local offices. All questions were answered by a member of the chiropractor’s office staff, who sometimes consulted with the chiropractor. The students reported that all routinely or usually took x-rays during the first visit, 40 said they treated “subluxations,” 41 recommended “maintenance” adjust- ments, 38 offered craniosacral therapy, 37 recommended treatment for newborn infants, 29 treated newborns, and at least 28 did not recommend routine vaccination for children.
Undercover Investigations of Chiropractors13
In 1989 Dr. William M. London visited 23 chiropractors in Ohio and Florida who had advertised free consultations or examinations. Each one espoused subluxation theory either during the consultation or in waiting room literature, and all but two recommended periodic preventive maintenance. Seventeen performed examinations. Of these, three identi- fied subluxations (at differing locations), three said his left leg was shorter than his right leg, and two said his right leg was shorter than his left. Seven recommended treatment, and one treated him with a motorized roller device before examining him. In 1994 ABC’s “20/20” reported on visits to 17 chiro- practors who had made it known through advertising or other means that they treated children. In one segment, an infant named Blake was taken by his mother to 9 chiropractors in the New York metropolitan area, accompanied by a “friend” who was carrying a hidden camera. Blake had experienced recurring ear infections, a problem that a pediatrician said could be managed with antibiotics and would eventually be outgrown. Every chiropractor found a problem, and all said they could help and recommended care ranging from several weeks to a lifetime. The first found “a misalignment between the second and third bones in his neck.” The second said it was “on the right side of his neck between the first and second bones.” The third, using muscle-testing, found “weakness in the adrenal glands.” The fourth said there was a subluxation because one of Blake’s legs was shorter than the other. The fifth claimed he could diagnose the boy’s problem by pulling on his mother’s arm while she touched the boy on the shoulder. The sixth chiropractor did a similar test by pulling on the mother’s legs while Blake lay on top of her back. After diagnosing “jamming of the occiput (the back bone of the skull),” the chiropractor said he corrected it by “lifting” Blake’s occiput with his thumbs. He also said (a) Blake needed work on his immune system, (b) a learn- ing disorder might be a problem, (c) both mother and son had “eyes that don’t team too well,” and (d) the cameraman, whom the chiropractor incorrectly assumed was the boy’s father, had the same eye problem. The same program also reported on visits to eight Wis- consin chiropractors by a 5-year-old boy with chronic ear infections so severe that medical doctors wanted to insert tubes in his ears to drain them. All eight chiropractors found problems, but not usually the same ones. One diagnosed a
techniques. However, their intent is never to correct subluxations; it is to relieve pain and secondary muscle spasm by restoring the mobility of joints that have a mechanical malfunction. The notion that nerve interference is a major cause of disease clashes with established anatomic facts. During
the early 1970s Dr. Edmund Crelin, a prominent anato- mist at Yale University, subjected subluxation theory to an actual test.14 After collecting the spines of six people who had died a few hours earlier, he twisted them with instruments and observed the spaces between the verte- brae through which the spinal nerves passed. No nerve
Part Two Health-Care Approaches168
compression occurred, regardless of the force applied. In a later memorandum he commented further:
Only 24 of the 43 pairs of nerves that pass from the brain and spinal cord to various parts of the body could ever be impinged upon in the [vertebral openings] by the excessive displacement of vertebrae. Why these 24 pairs should be causing disease, exclusive of all the others, defies a rational explanation. . . . Complete severance of spinal nerves to the heart, glands (salivary, thyroid, liver, pancreas, etc.) and smooth muscles of the lungs, stomach, intestines, etc., has only transient effects. The gland cells and smooth and cardiac muscles not only survive, but function normally. They surely do not become diseased.15
Despite the unscientific nature of the subluxation concept, a cross-sectional survey16 of North American chiropractors conducted in 2002 found that (a) 88.1% thought that the term vertebral subluxation should be retained, (b) 89.8% thought that spinal adjustment should not be limited to treating musculoskeletal conditions, and (c) 62.1% rated the subluxation as a significant contributing factor in visceral conditions (diseases of the internal organs), and (d) 76.5% taught patients about a relationship between subluxations and visceral health. Mainstream chiropractic organizations are also strongly tied to the subluxation concept. In 2000, the ACA House of Delegates reaffirmed its core principle of subluxation by passing this resolution:
The ACA will strive to reiterate this principle and further state that the core treatment of chiropractic is manual manipulation/ adjustment of the articulations, both spinal and extra-spinal, to reduce subluxations, when called upon in relation to Federal legislative efforts, in addition to full scope of practice as al- lowed by state law. References to subluxation and chiropractic adjustments/manipulation should be made in ACA releases, whenever possible.
In 1996, in an attempt to unify the profession, the Association of Chiropractic Colleges (ACC)17 adopted a subluxation-based “chiropractic paradigm” statement that contains this definition:
A subluxation is a complex of functional and/or structural and/or pathological articular changes that compromise neural integrity and may influence organ system function and general health. A subluxation is evaluated, diagnosed and managed through the use of chiropractic procedures based on the best available rational and empirical evidence.
In 2005, the World Federation of Chiropractic, an association of chiropractic organizations in 85 countries, adopted an “identity statement” based on a survey in which thousands of chiropractors were asked how the public should perceive them. The survey found that 65%
of respondents said that the phrase “management of vertebral subluxation and its impact on general health” fits chiropractic “perfectly” or almost perfectly.18 Subluxation theory is not only entrenched in the practices of chiropractors; it is also embodied in all 50 of the state laws that govern chiropractic regulation. Twenty-states authorize chiropractors to treat sublux- ations, 25 authorize them to treat purported vertebral malpositions that interfere with nerve flow (or similar wording), and five authorize the use of whatever is taught at chiropractic colleges.19 As a result, all states permit chiropractors to treat all or most diseases by adjusting subluxations to improve nerve flow.
ChiroprACtiC eduCAtion
In 1973 the U.S. Office of Education approved the Council on Chiropractic Education (CCE) to accredit chiropractic schools. In 2007, the requirements for ad- mission to a CCE-accredited school included 90 credit hours (about 3 years) of prechiropractic college educa- tion with at least a 2.5 (out of 4.0) grade-point average.20 To receive the doctor of chiropractic (D.C.) degree, students must complete at least 4200 hours of study over a 4-year period. Courses include anatomy, biochemistry, microbiology, pathology, public health, diagnosis and x- ray examination, related health sciences, and chiropractic principles and practice. Seventeen chiropractic programs in the United States have CCE accreditation. In 1968 a comprehensive study by the U.S. Depart- ment of Health, Education, and Welfare concluded that chiropractic education did not prepare its practitioners to make an adequate diagnosis and provide appropri- ate treatment.21 Chiropractic colleges have improved considerably since that time. However, all still discuss subluxations in their philosophy courses, some consider subluxations to be real entities, and a few still encour- age students to treat “subluxations” rather than diseases or “conditions.”22 The ACC paradigm statement says, “Chiropractic is concerned with the preservation and restoration of health, and focuses particular attention on the subluxation.”17 The statement was signed by all of the U.S. chiropractic college presidents in 1996 and is still considered current. In 2011 Mirtz and Perle23 reported that all but three of the chiropractic colleges in the United States and Canada mentioned “subluxation” in their catalogs and that the average number of course descriptions using the term ranged from 1 to 24, with an average of 5.2. Chiropractic colleges do not provide the depth of diagnostic and therapeutic training that physicians
Chapter Nine A Close Look at Chiropractic 169
receive. Whereas most medical school faculties are large and contain experts in every aspect of medical practice, chiropractic colleges have few or no physicians on their faculty. Whereas the patients studied by medical students encompass the full range of disease, the vast majority seen by chiropractic students seek help for musculoskel- etal problems. Although many of their courses are based on standard medical textbooks, chiropractic students lack much of the experience needed to make the information meaningful.24 Some chiropractors try to downplay their lack of clinical experience by claiming that they spend more hours than medical students do in one subject or an- other. These claims are misleading because nearly all medical doctors undergo at least 3 additional years of full-time clinical training before going into practice, whereas nearly all chiropractors enter practice directly after graduation from their 4-year program. Moreover, in chiropractic colleges, instruction in many subjects, including pediatrics, obstetrics, and gynecology, is confined to the classroom, with little or no actual patient contact and no experience with hospitalized patients.24 A team of research-oriented chiropractors recently stated: There is a tremendous void in how chiropractic graduates develop any meaningful hands-on clinical experience with real patients in real life situations. The chiropractic profession has an obligation to actively divorce itself from metaphysi- cal explanations of health and disease as well as to actively regulate itself in refusing to tolerate fraud, abuse and quackery, which are more rampant in chiropractic than in other health- care professions.”25
Critics also note that because much of chiropractic is based on a false premise, neither length of study nor accreditation of its schools can ensure that those who graduate will practice competently.
Practice-Building Techniques After graduation many chiropractors take courses to help build their practices. These courses teach efficient office
management, but some have taught unethical methods of recruiting and retaining patients. For example, one practice-building manual provided detailed instruc- tions for persuading all comers to have monthly spinal examinations.2 Another suggested telling patients that “the best health insurance you’ll ever buy is regular adjustments of your spine, releasing nerve pressures.”26 Both of these books were authored by chiropractic col- lege presidents and widely used for more than 30 years. Although neither book is still published, most current practice-builders teach the same techniques and thou- sands of chiropractors use them. A 1986 report by the Office of the Inspector Gen- eral (OIG)27 concluded that “practice-building courses, popular with many chiropractors, advocate advertising techniques which suggest the universal efficacy of chi- ropractic treatment for every ailment known to humans.” It also concluded that despite evidence of an increased emphasis on science and professionalism in the training and practice of chiropractors, “there also exist patterns of activity and practice which at best appear as overly aggressive marketing—and, in some cases, seem de- liberately aimed at misleading patients and the public regarding chiropractic care.” A subsequent OIG report noted that the two most common reasons for disciplinary actions by state chiro- practic boards are billing abuses (relating to utilization or fees) and advertising abuses.28 Figure 9-5 shows two types of stickers chiropractors use to promote their practices.
reseArCh Findings
Many studies have examined whether spinal manipu- lation can relieve back pain. Relatively few studies have looked at whether manipulation could help other problems. In properly selected cases, manipulation may relieve low-back pain of musculoskeletal origin. How- ever, there is little evidence that it is effective for other
Figure 9-5. Chiropractic promotional materials. Many chiropractors use messages that reinforce the idea of a special bond between themselves and their patients. The bumper sticker was distributed by the American Chiropractic Association. The heart sticker is from a company that sells novelty items to chiropractors. Several companies sell birthday cards and other greeting cards with chiropractic themes.
MY CHIROPRACTOR
LOVES ME
Part Two Health-Care Approaches170
musculoskeletal conditions and no evidence that it is effective for nonmusculoskeletal conditions. Homola29 has noted that “chiropractic research has yet to pinpoint what chiropractors do that is beneficial.” During the early 1990s, manipulation received considerable publicity after reviews by the RAND Cor- poration30 and the Agency for Health Care Policy and Research (AHCPR)31 concluded that manipulation was effective for acute low-back pain in patients with no signs of lower-limb nerve root involvement. Although chiropractors promoted these reports as endorsements of chiropractic, they were not. They merely supported the use of manipulation in carefully selected patients. Only a few of the studies on which their conclusions were based involved manipulation by chiropractors; most were done by medical doctors and physical therapists whose practices were not identical to those of chiropractors.12 Since that time, there have been many more studies and many more reviews. In 2003, a team that included RAND’s project leader concluded: “There is no evidence that spinal manipulation is superior to other standard treatments for patients with acute or chronic low back pain.”32 In 2005, after looking at 19 reviews related to back pain, Canter and Ernst33 concluded that “those authored by chiropractors tended to generate positive results, whereas the others failed to demonstrate effectiveness.” In 2006, Ernst and Canter34 reported on 16 systematic reviews of clinical trials of spinal manipulation published between 2000 and May 2005 on back pain, neck pain, headache, non-spinal pain, menstrual pain, infantile colic, asthma, allergy, neck-related dizziness, and medi- cal problems in general. They concluded:
These reviews were largely negative, except for back pain where spinal manipulation was considered superior to sham manipulation but not better than conventional treatments. . . . Collectively these data do not demonstrate that spinal manipu- lation is an effective intervention for any condition. Given the
possibility of adverse effects, this review does not suggest that spinal manipulation is a recommendable treatment.
A recent Cochrane35 review examined the effect of manipulation plus other modalities on low-back pain. The other modalities were heat and cold therapy, electro- therapy, mechanical devices, exercise, nutritional advice, orthotics, lifestyle modification, and patient education. The reviewers concluded that although combined chi- ropractic interventions slightly improved pain and dis- ability in the short term and pain in the medium term for acute and subacute low-back pain, “there is currently no evidence to support or refute that combined chiropractic interventions provide a clinically meaningful advantage over other treatments for pain or disability in people with low-back pain.” A subsequent review drew similar conclusions for chronic low-back pain.36
probleMs For ConsuMers
Although some research on the use of spinal manipula- tion is favorable, the situation faced by consumers is actually worse than these studies might seem to indicate. Most research on spinal manipulation is done in studies where the patients are appropriately screened and the treatment is limited by the experimental protocol. In the real world, however, the odds of getting appropriate treatment are much lower because the following prob- lems are widespread. Exaggerated Scope Many chiropractors exaggerate what they can achieve. Tedd Koren, D.C., publishes many brochures and other practice-building supplies, one of which states:
Nearly every condition to which the flesh is heir has responded to chiropractic, including ear infections, asthma, allergies, colic, bedwetting, hearing problems, skin conditions, diges- tive and menstrual problems, infertility, spine and nerve pain, colds and flu, headache, sciatica, emotional and neurological conditions and many others.37
Figure 9-6. “Danger signal” ad from phone directory. The ad is misleading because (a) most of the listed symptoms are unlikely to be caused by pinched nerves, (b) most cases involving these symptoms are not serious, and (c) some of the symptoms (such as difficult breathing) are far more likely to be appropriate for medical rather than chiropractic evaluation. Contour analysis has no diagnostic value.
Chapter Nine A Close Look at Chiropractic 171
Koren also advised chiropractors they could double their practice “practically overnight” by having patients read one of his lists of conditions treated and asking: “Do you know of any children, perhaps your own, or those of relatives or friends, that have any of the problems in this list?”38 A recent survey found that unsubstantiated claims are very common among chiropractic Web sites. In the fall of 2008, the researchers looked at the sites of 200 chiropractors and 9 chiropractic associations in Austra- lia, Canada, New Zealand, the United Kingdom, and the United States. Each site was examined for claims which suggested that chiropractic treatment was appropriate for asthma, colic, ear infection/earache/otitis media, neck pain, whiplash, headache/migraine, and lower back pain. The study found that 95% of the surveyed sites made unsubstantiated claims for at least one of these conditions and 38% made unsubstantiated claims for all of them. The authors concluded39: The majority of chiropractors and their associations in the English speaking world seem to make therapeutic claims that are not supported by sound evidence, while only 28% of chiropractor websites promote lower back pain, which is supported by some evidence. We suggest the ubiquity of the unsubstantiated claims constitutes an ethical and public health issue.
Patients who rely on exaggerated chiropractic claims may delay obtaining more appropriate care. Modde40 highlighted this problem when he said that “malpractice is an inevitable result of chiropractic philosophy and training.”
Unnecessary Treatment Many chiropractors claim that treating subluxations improves general health and is important throughout life. For example, in 1995 an ACA board member stated: “I treat my patients as if each spinal adjustment has a virtually unlimited potential in improving their health. My father adjusted me on the day that I came home from the hospital, and I did the same with my children.”41 Many chiropractors suggest unnecessary “spinal adjustments” for “preventative maintenance” or for treating nonexistent conditions. Maintenance care is typi- cally promoted with claims that undetected subluxations pose a serious health threat. A 2009 Koren pamphlet, for example, states: “Subluxations are sometimes referred to as ‘silent killers’ because they can slowly eat away at your health and vitality for years without your knowing it.”42 Figure 9-4 shows a poster used to reinforce this idea. Many chiropractors offer free evaluations with the hope that takers will contract for long-term care. These offers may be communicated through mall exhibits, free dinners, newspaper advertising, and various other channels. Figure 9-6 provides an example. The in-office sales pitch typically includes a recommendation for 50 to 100 visits over a 6- to 12-month period to promote wellness and/or prevent spinal degeneration. To increase compliance and discourage patients from stopping if their initial symptoms resolve, patients are offered a discount for advance payment. The Personal Glimpse box about “discount plans” describes what happened when a patient stopped coming because the treatment was not helpful.
s Personal Glimpse
West signed said that if she stopped before the 100 visits were completed, she would be charged at a nondiscounted rate for the visits she had and an additional 10% “admin- istrative fee.” However, the judge ruled that the penalty clause was “unconscionable” and that West had been misled and was entitled to a full refund. A small claims appeal judge reduced the award to $4589 but agreed that the contract was unreasonable. Chiropractors who offer “discount” plans should be avoided because such plans are a sign of overselling. Even when chiropractic treatment can be helpful, it is not possible to know in advance that a large specified number of visits will be needed.
Be Wary of Discount Plans
In 2008, in response to an advertisement, Gertrude West, a 76-year-old retired attorney, sought help from a chi- ropractor for knee pain. The chiropractor performed a cursory examination, some diagnostic tests, and an x-ray examination and advised West that she had “subluxation degeneration” that would worsen without intensive chiro- practic care. The chiropractor’s written report of findings called for 100 visits at a total cost of $7080, but if she signed a contract and paid in advance the price would be discounted (15%) to $6354. After 49 visits over a 4-month period, West concluded that she was not being helped and asked that payment for the unused visits be refunded. When the chiropractor refused, she sued him in small claims court. The contract
Part Two Health-Care Approaches172
Some patient-recruitment programs have been packaged as an opportunity to participate in research. In 2008, for example, several chiropractic Web sites began advertising for “research volunteers” who would be evaluated free of charge. After the evaluation, they would then be invited—as paying patients—to “com- mit to a 24-visit cycle, and continue coming until they reach their maximum potential.” The ads are part of a practice-building program offered by Research & Clini- cal Science (RCS), which promised chiropractors that it would tabulate data that would ultimately pinpoint “exactly what impact subluxations have on the body, and what benefits chiropractic might offer to people of various ages and health levels.” RCS also promised that its program would generate between 10 and 25 new patients a month and promote long-term wellness and compliance among existing patients. To join the pro- gram, chiropractors would pay $7384 in advance or up to $8384 for an installment plan. In return, RCS provided the training, research technology, wall plaque, brochures, and other materials needed to represent themselves as “RCS Authorized Clinical Investigators.”43
Dubious Practices and Procedures Many chiropractors use leg-length measurement, ther- mography, surface electromyography, or other dubious methods to detect alleged subluxations. The Chirobase Web site (www.chirobase.org) has detailed reports on these methods. Many chiropractors use applied kinesiology muscle- testing, hair analysis, or other dubious methods as a basis for prescribing unnecessary vitamins, irrational “dietary
supplement” formulations, herbs, and/or homeopathic products, most of which are sold to patients at two or three times their wholesale cost. Unsound uses of dietary supplements and herbs are discussed in Chapter 11 of this book. Homeopathy is covered in Chapter 8. Many chiropractors x-ray most or all of their patients to look for “subluxations.” About 10% of chiropractors still obtain 14 x 36-inch full-spine x-ray films, which yield little or no diagnostic information and involve relatively high levels of radiation. A 2003 survey by the National Board of Chiro- practic Examiners45 found that 89% of 2167 full-time practitioners who responded said they had used “nutri- tional counseling, therapy or supplements” within the previous year and that 46.4% said they had prescribed homeopathic remedies. Although not qualified by training to understand the use of prescription drugs, many chiropractors discourage their use.
Opposition to Immunization Many chiropractors say that vaccinations are ineffective and do not recommend them to their patients. In 1992, 36% of 178 chiropractors who responded to a survey agreed that “there is no scientific proof that immuniza- tion prevents infectious disease” and 23% said they were uncertain. In the same survey, 41% agreed that “immu- nization campaigns have not substantially changed the incidence of any infectious diseases in the 20th century” and 29% said they were unsure.46 A more recent study looked at vaccination rates obtained from insurance data compiled in the state of Washington from 2000 to 2003. The researchers found that vaccination rates were much lower among children who saw chiropractors and naturopaths than among those who relied only on medical doctors.47 The ACA, ICA, WCA, and International Chiro- practic Pediatric Association oppose compulsory vac- cination, and all but the ACA distribute anti-vaccination publications.48
Adverse Effects of Spinal Manipulation Most chiropractors manipulate the vast majority of patients who visit their office; some use techniques that have not been studied scientifically, and many empha- size a technique that is more vigorous (and therefore potentially less safe) than the controlled manipulation used by other practitioners. Manipulation, particularly of the neck, can be dangerous. In 1992 researchers at the Stanford Stroke Center asked 486 California members of the American Academy of Neurology how many patients they had seen
Avoiding Chiropractic Trouble
Consumer Reports44 has advised people to be suspi- cious of any chiropractor who does the following:
• Takes full-spine or repeated x-rays • Fails to take a comprehensive history and perform
a clinical examination to determine the cause of your trouble
• Claims that the treatment will improve immune function, benefit organ systems, or cure disease
• Offers to sell you vitamin cures, nutritional rem- edies, or homeopathic remedies
• Solicits children or other family members • Advises against the immunization of children • Wants you to sign a contract for long-term care • Promises to prevent disease through regular
checkups and spinal adjustments
√ Consumer Tip
Chapter Nine A Close Look at Chiropractic 173
A friend tells you that the day after she played vol- leyball, her back hurt and she consulted a chiropractor who examined her, obtained an x-ray film, manipu- lated her spine, and advised her to return the next day for a full report. The next day she felt completely normal but kept the appointment anyway. The chiro- practor was pleased but said he discovered that your friend has a spinal curvature that may make her prone to further difficulty. The chiropractor recommended weekly visits for a few weeks followed by monthly checkups and adjustments for “preventative mainte- nance.” What advice would you give?
It’s Your Decisionduring the previous 2 years who had suffered a stroke within 24 hours of neck manipulation by a chiropractor. The survey was sponsored by the American Heart As- sociation. The 176 neurologists who responded said that they had treated 56 such patients, all between the ages of 21 and 60. One patient had died, and 48 were left with permanent neurologic deficits such as slurred speech, inability to arrange words properly, and vertigo (severe dizziness). The neurologists also reported treating 46 cases of nerve or muscle injury.49 Although the percent- age of chiropractic patients who are seriously injured is small, injury caused by an unnecessary manipulation is inexcusable. In 1995, Assendelft and colleagues50 reviewed 295 published reports of complications and concluded (a) it is difficult to estimate the incidence of complications of spinal manipulation because they are underreported in the scientific literature, (b) information about the risk of stroke should be included in an informed consent procedure for neck manipulation that involves thrusting, and (c) practitioners using rotatory manipulation should be avoided. In 2008, Ernst51 reported that seven prospective stud- ies had found that about half of the patients who received spinal manipulation experienced mild-to-moderate, tran- sient adverse effects. Local or radiating pain, headache, and tiredness occurred most often. Spinal manipulation can also result in serious injury to nerves, disc herniation, and, with neck manipulation, dissection of the vertebral artery followed by stroke.52 Severe injuries are uncom- mon, but their actual incidence is unknown.53 suMMArY The terms “chiropractic” and “chiropractic treatment” are ambiguous and are not synonymous with “spinal manipulation.” Chiropractic is both a philosophy and a treatment approach. Chiropractic treatment may include a wide variety of dubious measures in addition to appro- priate or inappropriate manipulation. Thus, the potential usefulness of spinal manipulation may not counterbal- ance the unscientific philosophy or methods commonly embraced by chiropractors.
reFerenCes
1. Sabatier JA Jr., quoted in Carlova J. I visited a chiropractic college. Medical Economics, 1968.
2. Williams SE. Dynamic Essentials of the Chiropractic Principle, Practice and Procedure. Marietta Ga., (undated, circa 1991, purchased 1999), Si-Nel Publishing Co.
3. Barrett S. How chiropractors generally respond to criticism. Chirobase Web site, April 22, 2011.
4. Lomax E. Manipulative therapy: A historical perspective from ancient times to the modern era. In Goldstein M, editor. The Research Status of Spinal Manipulative Therapy. Monograph 15, 1975, National Institute of Neurological and Communicative Disorders and Stroke.
5. Palmer DD. The Chiropractor’s Adjuster: A Text-Book of the Science, Art and Philosophy of Chiropractic. Portland, Ore., 1910, Portland Printing House Company.
6. Smith RL. At Your Own Risk: The Case against Chiropractic. New York, 1969, Pocket Books.
7. Williams SE. Chiropractic Science & Practice in the United States. Arlington, Va., 1991, International Chiropractors Association.
8. Economic census data 1997 and 2007. U.S. Census Bureau Web site.
9. Jarvis WT. Chiropractic: A skeptical view. Skeptical Inquirer 12(4):47–55, 1987.
10. Bergmann TF. Chiropractic technique: An overview. In Law- rence DJ, editor. Advances in Chiropractic, Volume 2. St. Louis, 1996, Mosby.
11. Bergmann TF, Peterson DH. Chiropractic Technique: Principles and Procedures. St. Louis, 2011, Elsevier/Mosby.
12. Magner G. Chiropractic: The Victim’s Perspective. Amherst, N.Y., 1995, Prometheus Books.
13. Barrett S. Undercover investigations of chiropractors. Chirobase Web site, March 21, 2004.
14. Crelin E. A scientific test of the chiropractic theory. American Scientist 61:574–580, 1973.
15. Crelin E. Discussion of the newspaper advertising of Richard T. LaBarre, D.C., in the Bethlehem Globe-Times 1974–1975, prepared for the district attorney of Northampton County, Pa., in 1976.
16. McDonald W and others. How Chiropractors Think and Practice. Ada, Ohio, 2003, Ohio University Institute for Social Research.
17. Association of Chiropractic Colleges. A position paper on chiro- practic. Journal of Manipulative and Physiological Therapeutics 19:634–637, 1996.
18. Consultation on identity: Quantitative research findings. World Federation of Chiropractic presentation, Dec 7, 2004.
19. Bellamy JJ. Legislative alchemy: The US state chiropractic acts. Focus on Alternative and Complementary Therapies 15:214- 222, 2010.
Part Two Health-Care Approaches174
20. Standards for Doctor of Chiropractic Programs and Require- ments for Institutional Status. Scottsdale, Ariz., 2007, The Council on Chiropractic Education.
21. Cohen W. Independent Practitioners under Medicare: A Report to Congress. Washington, D.C., 1968, US Department of Health, Education, and Welfare.
22. What we teach. The Chiropractic Journal 8(1):34–36, 1993. 23. Mirtz TA, Perle SM. The prevalence of the term subluxation
in North American English-language doctor of chiropractic programs. Chiropractic & Manual Therapies 19:14, 2011.
24. Nelson CF. Chiropractic scope of practice. Journal of Manipula- tive and Physiological Therapeutics 16:488–497, 1993.
25. Murphy DR and others. How can chiropractic become a respected mainstream profession? The example of podiatry. Chiropractic & Osteopathy 16(10), 2008.
26. Parker JW. Textbook of Office Procedure and Practice Building for the Chiropractic Profession, 4th edition. Fort Worth, 1975, Parker Chiropractic Research Foundation.
27. Moran MC and others. Inspection of Chiropractic Services Under Medicare. Chicago, 1986, U.S. Department of Health and Human Services.
28. Kusserow RP. State Licensure and Discipline of Chiropractors. Washington, D.C., 1989, Office of Inspector General.
29. Homola S. Inside Chiropractic: A Patient’s Guide. Amherst, N.Y., 1999, Prometheus Books.
30. Shekelle PG and others. The Appropriateness of Spinal Ma- nipulation for Low-Back Pain. Part I: Project Overview and Literature Review. Santa Monica, Calif., 1991, RAND.
31. Bigos SJ and others. Acute Low Back Pain Problems in Adults. Clinical Practice Guideline No. 14. Rockville, Md., 1994, Agency for Health Care Policy and Research.
32. Assendelft WJJ and others. Spinal manipulative therapy for low back pain. Annals of Internal Medicine 138:871–881, 2003.
33. Canter PH, Ernst E. Sources of bias in reviews of spinal manipulation for back pain. Wiener Klinische Wochenschrift 117:333–341, 2005.
34. Ernst E. Canter PH. A systematic review of systematic reviews of spinal manipulation. Journal of the Royal Society of Medicine 99:192–196, 2006.
35. Walker BF and others. Combined chiropractic interventions for low-back pain. Cochrane Database of Systematic Reviews 2010, Issue 4. Article. No. CD005427.
36. Rubinstein SM and others. Spinal manipulation for chronic
low-back pain. Cochrane Database of Systematic Reviews 2011, Issue 2. Article. No. CD008112.
37. Koren T. Chiropractic bringing out the best in you! 7th Edition. Philadelphia, 2006, Koren Publications, Inc.
38. Koren T. How to get 5 to 10 new patients a week without leaving your office. Philadelphia, 1996, Koren Publications, Inc.
39. Ernst E, Gilbey A. Chiropractic claims in the English-speaking world. New Zealand Medical Journal 123:36–44, 2010.
40. Modde PJ. Malpractice is an inevitable result of chiropractic philosophy and training. Legal Aspects of Medical Practice, pp 20–23, Feb 1979.
41. Lynch RP Jr. Passion: Where has it gone? Journal of the Ameri- can Chiropractic Association 32(11):5–6, 1995.
42. Koren T. What is a subluxation? Philadelphia, 2009, Koren Publications, Inc.
43. Barrett S. Chiropractic “research” project is a marketing tool. Chirobase Web site, Jan 28, 2008.
44. Chiropractors. Consumer Reports 59:383–390, 1994. 45. Christenson MG. Job Analysis of Chiropractic: A Project Report,
Survey Analysis, and Summary of the Practice of Chiropractic within the United States. Greeley, Colo., 2005, National Board of Chiropractic Examiners.
46. Colley F, Haas M. Attitudes on immunization: A survey of American chiropractors. Journal of Manipulative and Physi- ological Therapeutics 17:584–590, 1994.
47. Downey L and others. Pediatric vaccination and vaccine- preventable disease acquisition: Association with care by complementary and alternative medicine providers. Maternal and Child Health Journal, published online, Sept 17, 2009.
48. Barrett S. Chiropractors and immunization. Chirobase Web site, June 12, 2005.
49. Lee KP and others. Neurologic complications following chi- ropractic manipulation: A survey of California neurologists. Neurology 45:1213–1215, 1995.
50. Assendelft WJJ and others. Complications of spinal manipula- tion: A comprehensive review of the literature. Journal of Family Practice 42:475–480, 1996.
51. Ernst E. Chiropractic: A critical evaluation. Journal of Pain and Symptom Management 35:544–562, 2008.
52. Barrett S. Chiropractic’s dirty secret: Neck manipulation and stroke. Quackwatch Web site, Jan 18, 2009.
53. Ernst E. Adverse effects of spinal manipulation: A systematic review. Journal of the Royal Society of Medicine 100:330–338, 2010.
Basic NutritioN coNcepts
The wide variety of great-tasting nutritious foods available today gives us more options for healthful eating than ever before. . . . Eating is a fun and enjoyable part of life. There’s no reason good nutrition can’t be too.
Doris Derelian, Ph.D., r.D.1
PresiDent, american Dietetic association
Good nutrition is neither complicated nor restrictive. Unless you have a severe metabolic disorder or other specific nutrition- related health problem, you can enjoy virtually every food . . . so long as you practice moderation, variety and balance.
Victor herbert, m.D., J.D. tracy stoPler KasDan, m.s., r.D.2
“According to his lawyer, making him eat spinach is a violation of his civil rights. He’s suing us for a million dollars.”
© medical economics, 1986
ChapteThreenePart Three Chapter Ten
Part Three Nutrition and Fitness176
• The fundamental principles of healthy eating are moderation, variety, and balance.
• A sensible diet based on the Dietary Guidelines for Americans and the USDA Food Guidance System will provide adequate amounts of essential nutrients for most people.
• Food product labels must disclose the amounts of fat and several other significant nutrients.
• Consumers seeking nutrition advice should choose their sources carefully.
Keep these poiNts iN MiNd as You studY this chapter
Key Concepts
N utrition is the science of food and how the body uses it in health and in disease. A working knowledge of basic nutrition will help you make
intelligent food choices and protect yourself against the vast array of misinformation you will encounter. This chapter discusses major food components, essential nutrients and their food sources, dietary guidelines, food labeling, and sources of trustworthy nutrition informa- tion. Nutrition quackery and weight control are covered in the following two chapters. The relationship between diet and heart disease is analyzed in Chapter 15.
Major Food coMpoNeNts
The major nutrient components of food are proteins, car- bohydrates, fats, vitamins, minerals, and water. Proteins, carbohydrates, and fats supply food energy (calories) and are needed in relatively large amounts. They are called macronutrients and are conveniently measured in grams. (Makros is a Greek word that means large.) Practically all foods contain mixtures of proteins, fats, and carbohydrates, although they are commonly clas- sified according to the predominant macrocomponent. Vitamins and minerals are needed in relatively small amounts for specific purposes, mainly to help regulate body functions. They are called micronutrients and are usually measured in milligram (mg) or microgram (µg) amounts. Water is the major component both in foods and in the human body, which is about 60% water. The body’s digestive system breaks food down into molecules small enough to be absorbed through intestinal walls into the bloodstream. The absorbed substances are metabolized and used for energy, growth and repair, and many other body functions. Proteins Proteins, the body’s main structural component, are used to make bone, connective tissue, muscle, skin, hair, and cell membranes. Proteins also function as enzymes,
hormones, antibodies, and as part of hemoglobin, which transports oxygen to the tissues. Protein molecules are too large to be absorbed through the walls of the small intestine and into the bloodstream. Digestive processes break proteins down into their component amino acid molecules which are small enough for absorption. Throughout our bodies, amino acids are reassembled into specific proteins needed for bodily structures and functions, or chemically converted for energy. There are about 20 amino acids in the foods we eat, eight or nine of which are essential in the diet because the body cannot manufacture them. The essential amino acids are isoleucine, leucine, lysine, methionine, phenyl- alanine, threonine, tryptophan, and valine; for infants, histidine also is essential. Protein sources are considered complete (of high quality) if they supply all of the essential amino acids in adequate amounts and incomplete (of poor quality) if they do not. Fats (Lipids) Lipid is the general term for fatty substances, includ- ing triglycerides (fats and oils), phospholipids (such as lecithin), and sterols (including cholesterol). In common usage, fats are lipids that are solid at room temperature, and oils are lipids that are liquid at room temperature. The fats commonly found in foods and in the body are triglycerides. Their molecules are composed of glyc- erol (an alcohol) plus three chainlike fatty acids. Fatty acids differ in the length of their molecular chains and their degree of saturation with hydrogen. Those filled to capacity with hydrogen are called saturated fatty acids. Chains that have room for two hydrogen atoms are called monounsaturated fatty acids. Those with room for four or more hydrogen atoms are called polyunsatu- rated. Linoleic acid and alpha-linolenic acid, which are polyunsaturated, are the only lipid nutrients recognized as essential for humans. Lipids in the diet contain many
Chapter Ten Basic Nutrition Concepts 177
other fatty acids, but these can be synthesized from other substances and are not essential. Triglycerides can contain combinations of fatty acids of all types. The dominant fatty-acid type determines the characteristics of the triglyceride. Oils tend to be richer in polyunsaturates, but palm oil and coconut oil are saturated. Other saturated fats originate from animals or are vegetable oils with hydrogen added by hydroge- nation, but fish oils are largely polyunsaturated. When oils are hydrogenated, they become pasty. The process changes some unsaturated fatty acids to saturated ones and rearranges others from their natural cis-configuration to trans-fatty acids.4 Cholesterol, an important component of cell membranes, is transported through the bloodstream in cholesterol-protein combinations. High-density lipo- protein (HDL) tends to carry cholesterol away from the arterial walls, and low-density lipoprotein (LDL) tends to deposit it there. Because saturated and trans fats tend to increase LDL levels and thereby increase the risk of coronary heart disease, the amounts in packaged foods must be specified on their labels. Chapter 15 looks closely at the relationships between dietary factors, lipoproteins, and heart disease.
Carbohydrates Carbohydrates are composed of carbon, hydrogen, and oxygen. They are excellent sources of energy and supply about half the calories consumed in the average American’s diet. Humans can digest two types of carbo- hydrates: starches and sugars. Sucrose (table sugar), the predominant sugar, is composed of glucose and fructose, both of which are sugars. Lactose (milk sugar) is also a significant dietary sugar. Cellulose, a carbohydrate that is indigestible by humans, is a component of dietary fiber and is not an energy source for humans. Starches are found in all grains from which breads, cereals, and pasta are made, and also in rice, potatoes, and other vegetables. Starches and most types of dietary fiber are complex carbohydrates composed of long chains of glucose molecules. Sugars that contain one or two sugar molecules are called simple carbohydrates. These include table sugar (obtained from sugar cane or sugar beets), honey, and corn syrup (including high- fructose corn syrup). Glucose has been called the universal sugar because it is the basic form of food energy. All carbohydrates must be metabolized by the body into glucose so that the energy in its molecular bonds can be used. Glucose circulates in the blood and is stored in the form of gly- cogen (animal starch), mainly in the liver and some in
the muscles. However, most extra calories, regardless of their source, are stored as body fat, a more concentrated form of stored energy than glycogen. If carbohydrate is not supplied in the diet, the body must use a less efficient process (described in Chapter 12) to break down fats and proteins for energy. Many food faddists claim that sucrose is a “deadly poison,” while complex carbohydrates are safer and more desirable. Foods that contain complex carbohy- drates are an important part of a balanced diet. However, as noted by Stare, Aronson, and Barrett3:
It is ridiculous to claim that one type of digestible carbohydrate is dangerously inferior to the others when all become glucose in the body anyway. All edible carbohydrates are safe when eaten in moderate amounts.
Dietary fiber. Dietary fiber (also called bulk or roughage) refers to plant components that are resistant to digestion by human gastrointestinal secretions. It includes a heterogeneous group of carbohydrate com- pounds (cellulose, hemicellulose, mucilages, pectin, and gums) and also a noncarbohydrate, lignin. Whole-grain foods are a major source of dietary fiber. Bran has 9% to 12% crude fiber; dry beans, lentils, and soybeans have over 4%; roasted nuts have 2.3% to 2.6%. Most fruits and vegetables contain 0.5% to 1% of fiber.
Did You Know?
Diet has always had a vital influence on health. Until as recently as the 1940s, diseases such as rickets, pellagra, scurvy, beriberi, xerophthalmia and goiter (caused by lack of adequate dietary vitamin D, niacin, vitamin C, thiamin, vitamin A, and iodine, respectively) were prevalent in this country and throughout the world. Today, thanks to an abundant food supply, fortification of some foods with critical trace nutrients, and better methods for determining and improving the nutrient content of foods, such “deficiency” diseases have been virtually eliminated in developing countries. . . . As the diseases of nutritional deficiency have diminished, they have been replaced by diseases of dietary excess and imbalance—problems that now rank among the leading causes of death, touch the lives of most Americans, and generate substantial health care costs. . . .
C. Everett Koop, M.D.5 Former Surgeon General U.S. Public Health Service
Historical Perspective
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Naturally occurring fiber in food is usually a mixture of water-soluble fibers (pectins, gums, and mucilages, which can dissolve in water), insoluble fibers (cellulose and lignin), and combinations of insoluble and soluble fibers (hemicellulose). Oat bran and oatmeal contain relatively large amounts of soluble fiber. Whole wheat contains relatively large amounts of insoluble fiber. Fiber in the intestinal tract holds water, improving the body’s reservoir for hydration. It also makes the feces bulkier (heavier) and softer, which enables them to pass more quickly and easily through the intestines. Low-fiber diets often result in constipation. Epidemiologists have found that prolonged lack of dietary fiber is associated with gastrointestinal, circulatory, and metabolic prob- lems such as diverticulitis (inflamed outpouches in the large intestine), hemorrhoids, increased blood choles- terol levels, obesity, and diabetes.6 Because foods high in fiber have a variety of fiber components and tend to be low in fat, it is difficult to design studies that can test for specific effects of fiber. Much research needs to be done to determine which com- ponents, if any, might be most useful and the amounts of these components that would be optimal. However, it is known that increasing the amount of soluble fiber can help lower high blood-cholesterol levels and that increas- ing total dietary fiber is useful in treating constipation and hemorrhoids.
All major scientific groups that have issued dietary guidelines agree that it is desirable for one’s overall diet to contain adequate amounts of dietary fiber. The Food and Drug Administration (FDA) does not believe there is adequate evidence to permit manufacturers to claim that the amount of fiber in individual food products can help prevent cancer or lower the risk of cardiovascular dis- ease, but it does allow claims involving fiber-containing foods as part of a healthful diet (see Table 10-5, page 190). Chapter 15 covers the importance of soluble fiber in the treatment of high cholesterol levels. A study prepared for the FDA by the Federation of American Societies for Experimental Biology (FASEB) recommends that healthy adults consume 20 to 35 g of fiber per day, which corresponds to approximately 10 to 13 g per 1000 calories of food. The report concluded that achieving this level of intake is feasible by select- ing ordinary foods that are currently available and that many Americans already did so.7 Fiber intake can be increased by eating more whole-grain breads and cere- als, fruits, vegetables, legumes, and nuts. But even fiber that occurs naturally should be eaten in moderation. A high-fiber diet can cause one to feel stuffed or bloated; can cause diarrhea; and can interfere with the absorption of iron, copper, zinc, and calcium. Purified fibers and fiber supplements are generally not recommended for individuals who are able to obtain fiber from food.
FuNctioNs aNd Food sources oF Major NutrieNts
Table 10–1
Nutrient Protein
Carbohy- drate
Fat
Vitamins and minerals
Water
Major Functions in Body Forms cell structure; supports growth, main- tenance, and repair of tissue; needed for enzymes and hormones
Serves as primary energy source; can pro- vide fiber for proper digestive function
Serves as concentrated energy source; sup- plies essential fatty acid; carries fat-solu- ble vitamins
Perform various functions to help regulate body processes; necessary to obtain en- ergy from foods
Transports nutrients; helps regulate body temperature; aids in digestion
Best Food Sources Meat, poultry, fish, dry beans, eggs, nuts Milk, yogurt, and cheese
Bread, cereal, rice, and pasta Fruits and vegetables
Milk group: whole-milk products Meat group: meats, nuts, peanut butter Other sources: butter, margarine, oils, salad dressing, fried foods, and many processed foods
Fruits and vegetables: vitamins A and C, folic acid Bread group: B vitamins Milk group: calcium, phosphorus, riboflavin Meat group: B vitamins, iron, zinc
Water and other beverages Fruit and vegetable groups Milk group: milk
Chapter Ten Basic Nutrition Concepts 179
safe and adequate consumption of individual nutrients. The U.S. Department of Agriculture (USDA) Food Guidance System—now called MyPlate—addresses both nutrient adequacy and disease prevention.
Dietary Guidelines for Americans (DGA) The DGA, developed jointly by the U.S. Department of Health and Human Services and the USDA, provides recommendations based on current scientific knowledge about how dietary intake and exercise may reduce risk for major chronic diseases and how a healthful diet may improve nutrition. The guidelines, which are intended for healthy children (age 2 and older) and adults, form the basis of federal food, nutrition education, and in- formation programs. They address the question, “What should Americans eat to have the best chance of staying healthy?” Since 1980, they have been reviewed every 5 years, as required by federal law.8 The 2010 Dietary Guidelines9 include 23 “key rec- ommendations” for the general population and six key recommendations for specific population groups (see Table 10-2). The recommendations are based on two over-arching concepts: 1. Maintain calorie balance over time to achieve and sustain a healthy weight. To curb the obesity epidemic and improve their health, many Americans must decrease the calories they consume and increase the calories they expend through physical activity. The 2008 Physical Activity Guidelines for Americans (see Chapter 14) provide an appropriate standard. 2. Focus on consuming nutrient-dense foods and beverages. A healthy eating pattern limits intake of
Vitamins Vitamins are organic (carbon-containing) substances required in tiny amounts to promote one or more specific biochemical reactions. Only tiny amounts are necessary because vitamins are catalysts (substances that initiate or speed up chemical reactions but remain unchanged while performing their tasks repeatedly). Vitamins do not provide energy directly but are part of the enzyme systems needed to release energy from carbohydrates, fats, and proteins. There are 13 known vitamins for humans: four are fat-soluble (A, D, E, and K) and nine are water-soluble (C and the eight B-complex vitamins: thiamin [B1], riboflavin [B2], niacin, B6, B12, folic acid, biotin, and pantothenic acid). Since patients can survive for many years without becoming ill on intravenous feedings fortified with these substances, it appears that no vitamins remain to be discovered. Vitamins must be obtained from food because the human body cannot manufacture them, but a few are also made within the body. Vitamin D is made in the skin when it is exposed to sunlight, and biotin and vitamin K are made by bacteria in the large intestine. Vitamin deficiency diseases are rare in the United States because vitamins are plentiful in the food sup- ply, both naturally and through fortification. Popula- tion groups at risk for deficiency are identified in Chapter 11. Minerals Minerals are inorganic compounds needed in relatively small amounts to help regulate body functions, aid in growth and maintenance of body tissues, and act as cata- lysts for the release of energy. The 17 essential minerals may be categorized as major minerals (macrominerals) or trace minerals (microminerals). The macrominerals are those present in the body in amounts exceeding 5 g: calcium, phosphorus, magnesium, sodium, potassium, chloride, and sulfur. Sodium, potassium, and chloride are called electrolytes because, in solution, they help to conduct electrical currents. The essential trace miner- als are chromium, cobalt, copper, fluoride, iodide, iron, manganese, molybdenum, selenium, and zinc. Table 10-1 identifies the functions and best food sources of the major nutrients.
MeetiNg NutrieNt Needs
Several sets of federal guidelines are available to help people make intelligent dietary choices. The Dietary Guidelines for Americans (DGA) provide practical advice for healthful food choices. The Dietary Reference Intakes (DRIs) define what is known about the ranges of
Smart shoppers pay close attention to nutrition labels. Source: USDA SNAP-Ed Photo Gallery
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dietarY guideliNes For aMericaNs 2010: KeY recoMMeNdatioNs9
Table 10-2
Women capable of becoming pregnant • Choose foods that supply heme iron, which is more readily absorbed by the body, additional iron sources, and enhancers of iron absorption such as vitamin C- rich foods.
• Consume 400 micrograms (µg) per day of synthetic folic acid (from fortified foods and/or supplements) in addition to food forms of folate from a varied diet.
Women who are pregnant or breastfeeding • Consume 8 to 12 ounces of seafood per week from a variety of seafood types.
• Due to their methyl mercury content, limit white (albacore) tuna to 6 ounces per week and do not eat tilefish, shark, swordfish, and king mackerel.
• If pregnant, take an iron supplement as recommended by an obstetrician or other health care provider.
Individuals ages 50 years and older • Consume foods fortified with vitamin B12, such as fortified cereals, or dietary supplements.
Foods and food components to reduce • Reduce daily sodium intake to less than 2300 mil- ligrams (mg) and further reduce intake to 1500 mg among persons who are 51 and older and those of any age who are African American or have hyperten- sion, diabetes, or chronic kidney disease. The 1500 mg recommendation applies to about half of the U.S. population, including children, and the majority of adults.
• Consume less than 10 percent of calories from satu- rated fatty acids by replacing them with monounsatu- rated and polyunsaturated fatty acids.
• Consume less than 300 mg per day of dietary cholesterol.
• Keep trans fatty acid consumption as low as possible, especially by limiting foods that contain synthetic sources of trans fats, such as partially hydrogenated oils, and by limiting other solid fats.
• Reduce the intake of calories from solid fats and added sugars.
• Limit the consumption of foods that contain refined grains, especially refined grain foods that contain solid fats, added sugars, and sodium.
• If alcohol is consumed, it should be consumed in mod- eration—up to one drink per day for women and two drinks per day for men—and only by adults of legal drinking age.
Food and nutrients to increase. Meet the following recommendations as part of a healthy eating pattern and while staying within calorie needs. • Increase vegetable and fruit intake. • Eat a variety of vegetables, especially dark-green and red and orange vegetables and beans and peas.
• Consume at least half of all grains as whole grains. Increase whole-grain intake by replacing refined grains with whole grains.
• Increase intake of fat-free or low-fat milk and milk products, such as milk, yogurt, cheese, or fortified soy beverages.
• Choose a variety of protein foods, which include seafood, lean meat and poultry, eggs, beans and peas, soy products, and unsalted nuts and seeds.
• Increase the amount and variety of seafood consumed by choosing seafood in place of some meat and poultry.
• Replace protein foods that are higher in solid fats with choices that are lower in solid fats and calories and/or are sources of oils.
• Use oils to replace solid fats where possible. • Choose foods that provide more potassium, dietary fiber, calcium, and vitamin D, which are nutrients of concern in American diets. These foods include vegetables, fruits, whole grains, and milk and milk products.
Balancing calories to manage weight • Prevent and/or reduce overweight and obesity through improved eating and physical activity behaviors.
• Control total calorie intake to manage body weight. For people who are overweight or obese, this will mean consuming fewer calories from foods and beverages.
• Increase physical activity and reduce time spent in sedentary behaviors.
• Maintain appropriate calorie balance during each stage of life—childhood, adolescence, adulthood, pregnancy and breastfeeding, and older age.
Building healthy eating patterns • Select an eating pattern that meets nutrient needs over time at an appropriate calorie level.
• Account for all foods and beverages consumed and assess how they fit within a total healthy eating pattern.
• Follow food safety recommendations when preparing and eating foods to reduce the risk of foodborne illnesses.
Chapter Ten Basic Nutrition Concepts 181
1. estimateD aVerage requirement (ear): The intake that meets the estimated nutrient need of 50% of the individuals in a specific group. This figure will be used as the basis for developing the RDA and can be used by nutrition policy- makers to evaluate the adequacy of nutrient intakes for population groups.
2. recommenDeD Dietary allowance (rDa): The intake that meets the nutrient needs of nearly all healthy individuals in specific age and gender groups. The RDA should be used in guiding individuals to achieve adequate nutrient intake aimed at decreasing the risk of chronic disease. It is based on estimating an average requirement plus an increase to account for the variation within a particular group. If indi- vidual variation in requirements is well defined, the RDA is set at 2 standard deviations above the EAR, which means it should be high enough to meet the needs of at least 97% to 98% of the population. If sufficient data are not available, the RDA is set at 1.2 x EAR.
3. aDequate intaKe (ai): When sufficient scientific evidence is not available to estimate an average requirement, AIs will be set. These are derived through experimental or observa- tional data that show a mean intake that appears to sustain a desired indicator of health, such as calcium retention in bone. The AIs should be used as a goal for individual intake where no RDAs exist.
4. tolerable uPPer intaKe leVel (ul): The maximum intake that is unlikely to pose risks of adverse health effects in almost all healthy individuals in a specified group. The UL is not a recommended level of intake, and there is no established benefit for individuals to consume nutrients at levels above the RDA or AI. The term “tolerable upper intake level” was chosen to avoid implying a possible beneficial effect. For most nutrients, it refers to total intake from food, fortified food, and supplements.
The DRIs are intended to apply to the healthy general population. The RDAs and AIs refer to average daily in- take over 1 or more weeks. They may not be sufficient to supply individuals who are already malnourished or who have a disease state marked by increased requirements. Individuals in these categories, or who have increased sensitivity to developing adverse effects associated with higher intakes, should be guided by qualified medical and nutrition personnel. Intake less than the RDA does not necessarily mean that a given individual is not getting enough of that nutri- ent. Half the RDA is usually sufficient. Healthy people who meet the AI have a low risk of inadequate intake. However, an intake well below the RDA or AI would be a reason to assess the individual’s nutritional status through laboratory testing or clinical examination. In many cases, various levels of intake can have different benefits. One level may be related to the risk of deficiency, for example, whereas another level can
sodium, solid fats, added sugars, and refined grains and emphasizes nutrient-dense foods and beverages—veg- etables, fruits, whole grains, fat-free or low-fat milk and milk products, seafood, lean meats and poultry, eggs, beans and peas, and nuts and seeds. For most Americans, this will involve shifting to a more plant-based diet.
Dietary Reference Intakes (DRIs) The DRIs are nutrient-based reference values for use in planning and assessing diets. They are an expansion of the Recommended Dietary Allowances (RDAs) that the National Academy of Sciences has published since 1941. They have been determined by the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine (IOM), National Academy of Sciences, with help from Health Canada (Canada’s federal health department). The National Academy Press published the DRIs as a series of seven books released between 1997 and 2004.10 The first covers nutrients related to bone health (calcium, phosphorus, magnesium, vitamin D, and fluoride). The second covers folate and other B vitamins. The third is about antioxidants (vitamin C, vitamin E, selenium, and carotenoids). The others cover macronutrients (e.g., protein, fat, carbohydrates); trace elements (e.g., iron, zinc); electrolytes and water; and other food components (e.g., fiber, phytoestrogens). The DRIs for calcium and vitamin D were revised in 2010.10 The reports can be read online free-of-charge or purchased at a discount at www.nap.edu. The RDAs, published periodically since 1941, have been the benchmark of nutritional adequacy in the United States.11 More than 20 years ago, they were defined as: “The levels of intake of essential nutrients that, on the basis of scientific knowledge, are judged by the Food and Nutrition Board to be adequate to meet the known nutrient needs of practically all healthy persons.” Since that time, scientific knowledge about the roles of nu- trients has expanded dramatically. Many studies have examined relationships between diet and chronic disease. The Food and Nutrition Board has responded to these developments by changing its basic approach to setting nutrient reference values. The DRIs reflect a shift in emphasis from prevent- ing deficiency to decreasing the risk of chronic disease through nutrition. The RDAs were based on the amounts needed to protect against deficiency diseases. Where adequate scientific data exist, the DRIs include levels that can help prevent cardiovascular disease, osteoporosis, certain cancers, and other diseases that are diet-related. Instead of a single category, the DRIs encompass four.
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influence the risk of chronic disease. Therefore, “nutrient adequacy” should be expressed in terms of “Adequate for what?” For this reason, the DRIs are far more elaborate than the RDAs and cannot be expressed in a simple table of values. A sensible diet can provide adequate amounts of all essential nutrients. Most individuals do not need supple- mentary vitamins, minerals, protein, or amino acids. However, as noted later in this chapter, a few nutrients may need special attention.
Food-group sYsteMs
The fundamental principles of healthful eating are mod- eration, variety, and balance. Healthful eating should also be psychologically satisfying and pleasing to the senses. A diet is balanced if it contains appropriate amounts of each nutrient. Food guides enable consum- ers to select foods from groups of nutritionally related foods rather than having to calculate the amount of each nutrient in each individual portion. Such guides, which specify the size and number of servings needed daily from each group to provide nutritional adequacy, have been published since 1916 by the USDA and various nongovernmental agencies.13
During the past two decades, the food-group systems have incorporated the principles of the U.S. Dietary Guidelines. The 2010 version9 uses five groups:
fruit grouP includes all fresh, frozen, canned, and dried fruits and fruit juices. In general, 1 cup of fruit or 100% fruit juice, or ½ cup of dried fruit can be considered as 1 cup from the fruit group.
Vegetable grouP includes all fresh, frozen, canned, and dried vegetables and vegetable juices. In general, 1 cup of raw or cooked vegetables or vegetable juice, or 2 cups of raw leafy greens can be considered as 1 cup from the vegetable group.
grains grouP includes any food made from wheat, rice, oats, cornmeal, barley, or another cereal grain. Bread, pasta, oatmeal, breakfast cereals, tortillas, and grits are examples. In general, 1 slice of bread, 1 cup of ready-to-eat cereal, or ½ cup of cooked rice, pasta, or cooked cereal can be considered as 1 ounce equivalent from the grains group. At least half of all grains consumed should be whole grains.
Protein fooDs grouP includes all foods made from meat, poul- try, seafood, beans and peas, eggs, processed soy products, and nuts. Beans and peas are also part of the Vegetable Group. In general, 1 ounce of lean meat, poultry, or fish, 1 egg, 1 Tbsp. peanut butter, ¼ cup cooked dry beans, or ½ ounce of nuts or seeds can be considered as 1 ounce equivalents from the meat and beans group.
Dairy grouP includes all fluid milk products and many foods made from milk. Most Dairy Group choices should be fat-free or low-fat. Foods made from milk that retain their calcium content are part of the group. Foods made from milk that have little to no calcium, such as cream cheese, cream, and butter, are not. Calcium-fortified soymilk (soy beverage) is also part of the Dairy Group. In general, 1 cup of milk or yogurt, 1½ ounces of natural cheese, or 2 ounces of processed cheese can be considered as 1 cup from the milk group.
A variety of foods should be chosen within each group. The recommended intakes depend on the indi- vidual’s activity level. Nutrient and energy contribu- tions from each group are based on the amounts in the nutrient-dense forms of foods in each group. Nutrient density can be expressed as nutrients per calorie. Nutrient-dense foods provide substantial amounts of vitamins and minerals (micronutrients) and relatively few calories. Such foods (a) are naturally rich in vitamins, minerals, and phytochemicals (plant chemicals), (b) are lean or low in solid fats, (c) do not have added solid fats, sugars, starches, or sodium, and (d) retain naturally occurring components such as fiber. All vegetables, fruits, whole grains, fish, eggs, and nuts prepared without added solid fats or sugars are consid- ered nutrient-dense, as are lean or low-fat forms of fluid milk, meat, and poultry prepared without added solid fats or sugars.
√ Consumer Tip
Biochemical Individuality Victor Herbert, M.D.12, a member of the 1980–1985 RDA committee, has noted:
To promote supplements, health hustlers misrepresent the concept of “biochemical individuality” (our genetic blueprint) to imply that individuals should consume more than the RDAs in case they have greater-than- average needs. . . . RDAs are deliberately set higher than virtually all normal people require in order to encompass the range of individual variations. . . . In other words, biochemical individuality has been taken into account.
Many high-priced (usually high-dose) supplements are supposedly formulated to meet the “special” needs of athletes, executives, or others categorized by activities or age. The intended target group is suggested by the product’s name (for example, Coach’s Formula, Exec- 30, Teenplex, Ger-E-Time). Some RDA-level products designed for men, women, or individuals older than 50 are rationally formulated. However, the idea that many segments of the American population have “special” needs that make supplementation advisable has no scientific foundation (see Chapter 11).
Chapter Ten Basic Nutrition Concepts 183
evaluatiNg Your diet
The Internet-based USDA Food Guidance System offers practical ways to plan and evaluate your diet. Interactive pages on the www.choosemyplate.gov site enable users to key in their age, gender, and physical activity level to get personalized recommendations for their daily calorie intake and suggestions for making wise choices from each food group. Versions for children 6 to 11 years old and their teachers are also available. Figure 10-1 shows the MyPlate symbol and 10 basic principles of the Food Guidance System. ChooseMyPlate.gov also offers a dietary assessment and links to nutrient information. After providing a day’s worth of dietary information, the user receives an overall evaluation that compares the amounts of food consumed to current nutritional guidelines. To better understand
their diet over time, registered users can track what they eat for up to 1 year. There is also a physical activity as- sessment that is accompanied by detailed advice. Other Internet-based computer programs and soft- ware for dietary analysis vary greatly in quality and ease of use and may require the user to spend considerable time and effort to measure portion sizes and enter the data. The best programs are user-friendly and include a large database of brand-name foods.
guideliNes For iNFaNts aNd toddlers
The American Academy of Pediatrics (AAP) recom- mends that nearly all infants be breast-fed and that breast-feeding continue for at least 12 months and thereafter for as long as mutually desired by mother and child.14 For infants who are not breast-fed, or who are
Figure 10-1. Symbol and basic principles of the new USDA Food Guidance System.
Choose MyPlate 10 tips to a great plate
Making food choices for a healthy lifestyle can be as simple as using these 10 Tips. Use the ideas in this list to balance your calories, to choose foods to eat more often, and to cut back on foods to eat less often.
1. Balance calories. Find out how many calories YOU need for a day as a first step in managing your weight. Go to www.ChooseMyPlate.gov to find your calorie level. Being physically active also helps you balance calories.
2. Enjoy your food, but eat less. Take the time to fully enjoy your food as you eat it. Eating too fast or when your attention is elsewhere may lead to eating too many calo- ries. Pay attention to hunger and fullness cues before, during, and after meals. Use them to recognize when to eat and when you’ve had enough.
3. Avoid oversized portions. Use a smaller plate, bowl, and glass. Portion out foods before you eat. When eating out, choose a smaller size option, share a dish, or take home part of your meal.
4. Foods to eat more often. Eat more vegetables, fruits, whole grains, and fat-free or 1% milk and dairy products. These foods have the nutrients you need for health—in- cluding potassium, calcium, vitamin D, and fiber. Make them the basis for meals and snacks.
5. Make half your plate fruits and vegetables. Choose red, orange, and dark-green vegetables like tomatoes, sweet potatoes, and broccoli, along with other vegetables for your meals. Add fruit to meals as part of main or side dishes or as dessert.
6. Switch to fat-free or low-fat (1%) milk. They have the same amount of calcium and other essential nutrients as whole milk, but fewer calories and less saturated fat.
7. Make half your grains whole grains. To eat more whole grains, substitute a whole-grain product for a re- fined product—such as eating whole-wheat bread instead of white bread or brown rice instead of white rice.
8. Foods to eat less often. Cut back on foods high in solid fats, added sugars, and salt. They include cakes, cookies, ice cream, candies, sweetened drinks, pizza, and fatty meats like ribs, sausages, bacon, and hot dogs. Use These foods as occasional treats, not everyday foods.
9. Compare sodium in foods. Use the Nutrition Facts la- bel to choose lower sodium versions of foods like soup, bread, and frozen meals. Select canned foods labeled “low sodium,” ”reduced sodium,” or “no salt added.”
10. Drink water instead of sugary drinks. Cut calories by drinking water or unsweetened beverages. Soda, en- ergy drinks, and sports drinks are a major source of added sugar, and calories, in American diets.
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only partially breast-fed, the AAP recommends iron- fortified formulas. The Federal Food, Drug, and Cosmetic Act defines infant formula as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.”15 Formulas include powders, concentrated liquids, or ready-to-use forms. Most formulas on the market are cow milk-based and some are free of the milk sugar lactose. Hydrolyzed formulas, which have smaller, more easily digestible protein molecules than other formulas, may be recommended for infants at risk of developing food allergies. So-called hypoallergenic formulas are recommended for babies who have food allergies, but who aren’t breast-fed. Soy-based and various formulas for infants with special needs are also available. The FDA specifies that infant formulas contain minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. Parents should obtain advice from their child’s health-care provider regarding infant feeding. The AAP Web site (www.healthychildren.org) offers guidance on choosing a formula; preparing, sterilizing, and storing formula; the amount and schedule of feedings; switch- ing to solid foods; and other issues in infant and child nutrition. The most comprehensive nutrition guidelines16 for infants and toddlers were published in 2004 through a joint effort of the American Dietetic Association (ADA) and Gerber Products Company with help from outside consultants. The following suggestions are consistent with these guidelines. Children younger than 2 are not “little adults.” Un- like adults, they do not require variety to secure nutrition during the first 6 months or so of life. Except for fluoride and vitamin D (in the absence of sunlight), human milk alone provides the vitamins, minerals, carbohydrates, fats, and proteins needed for normal growth and develop- ment during early infancy. After 6 months, most infants need supplementary foods to meet current recommen- dations for energy, manganese, iron, fluoride, vitamin D, vitamin B6, niacin, zinc, vitamin E, magnesium, phosphorus, biotin, and thiamin. Single-grain cereal is often the first food added. Other single-ingredient foods can be added gradually until the baby is eating a variety of foods. New foods should be added one at a time, at intervals of a few days. This allows the baby to get used to the flavor of the food and can reveal whether a food might not agree with the baby. There is no evidence that
introducing supplemental foods in any specific sequence or at any specific rate is beneficial. Repeated exposures are often necessary before a particular food is accepted. From 6 months to 3 years of age, children require fluoride supplementation only if the water supply is severely deficient in fluoride (less than 0.3 ppm). This should be discussed with the child’s doctor. Although healthy infants can vary considerably from one another in their caloric intake, appetite is likely to be the most efficient way to determine what an infant needs. Most infants instinctively know how much food they need and will not undereat or overeat unless pres- sured. Babies should be fed when hungry but should not be forced to finish the last few ounces of formula or food. Physicians routinely check whether growth and development are progressing normally. Although low-fat and low-cholesterol diets are widely recommended for adults, they are not appropri- ate for children younger than age 2. Infants require fat in their diet for normal growth and development. Bottles of milk or juice or a pacifier dipped in honey should not be used to put a baby to sleep because prolonged contact with their natural sugars can cause tooth decay usually referred to as “baby bottle decay.” Artificially sweetened foods should be avoided because they lack the calories that growing babies need. Infants are born with enough stored iron for 4 to 6 months. During this period, human milk or cow milk– based formulas usually supply sufficient amounts of zinc and calcium. After that, iron is more likely than any other nutrient to be lacking in the infant’s diet. For this reason, special efforts should be made to provide infants with iron during the first 2 years. In addition to breast milk, the best sources are meats and poultry, iron- fortified formula, and iron-fortified infant cereal. Dietary sources of zinc include oat cereals, meats and poultry, wheat germ, egg yolk, and cheddar cheese. Calcium is abundant in milk and other dairy products. Infants with a strong family history of food allergy should be breast-fed for as long as possible and should not receive complementary foods until 4 to 6 months of age. In 2008, the American Academy of Pediatrics17 concluded that there are insufficient data to conclude that further exclusion will prevent allergies from developing.
vegetariaNisM
Vegetarians are individuals who restrict or eliminate foods of animal origin (meat, poultry, fish, eggs, milk) from their diet. The main reasons people choose a
Chapter Ten Basic Nutrition Concepts 185
vegetarian alternative are: (a) they think it is healthier, (b) they think it is more “natural,” (c) they think it is more “ecologic” because it takes less energy to produce vegetarian food than animal products, and (d) they are following religious or moral dictates. Vegetarians can be classified into categories based on which foods they exclude from their diet:
Vegans or strict Vegetarians: Eat no animal products at all. lactoVegetarians: Consume milk and other dairy products in addition to plant foods. This form of vegetarianism is common among Seventh-day Adventists.
lacto-oVo-Vegetarians: Eat no meat, poultry, or fish, but do eat eggs and milk products.
Pesco-Vegetarians: Eat no meat but include fish, eggs, and milk products.
semi-Vegetarians: Eat no red meat, but do include small amounts of poultry and/or fish in their diet.
Possible Benefits of Vegetarianism Vegetarianism based on sound nutrition principles can be a healthful lifestyle choice, but neither vegetarians nor omnivores have a monopoly on healthful eating. Similar health benefits can be gained from well-selected diets of either type. The following are possible advantages of a vegetarian diet.
• Vegetarians, especially those who abstain from all animal foods, tend to eat less fat and have a lower body weight for their height than nonvegetarians do.
• Vegetarians have less constipation than meat-eaters. • Vegetarianism, as practiced by Seventh-day Adventists, has been associated with lower death rates from certain cancers (although abstention from tobacco and alcohol may be responsible for this).
• Vegetarianism may be associated with a lower incidence of atherosclerotic heart disease, high blood pressure, and diabetes. Lower body weight and/or nondietary factors may be contributory factors.
Possible Risks of Vegetarianism Vegetarians of all types can achieve recommended nutrient intakes through careful selection of foods. To avoid deficiencies, however, careful attention must be paid to food selection. Dr. William T. Jarvis has encoun- tered many tragedies in which cultlike adherence to a vegetarian ideology led people to starve themselves or their children to death or to substitute an ineffective “diet cure” for proven medical treatment.18 Foods of both animal and vegetable origin provide protein. However, proteins vary in nutritional quality because they differ in the kinds and amounts of amino acids they contain. Proteins from meat, fish, poultry,
milk, and eggs rate the highest because they supply all of the essential amino acids in about the same propor- tions as those needed by the body. The proteins from some legumes (particularly soybeans and chickpeas) are close in nutritional quality to those from animal sources. Combining a small amount of animal protein with plant foods helps to improve the overall protein quality of the diet. High-quality protein can also be obtained by con- suming plant foods that are complementary; in other words, the essential amino acids insufficient in one food are provided by another food with an adequate amount. Succotash is an example of a high-quality mixture of complementary foods (corn and lima beans). Unless they choose a proper balance of foods, strict vegetarians are at risk for several deficiencies, especially vitamin B12. They also risk deficiencies of riboflavin, calcium, iron, and the essential amino acids lysine and methionine. Vegetarian children not exposed to sunlight are at risk for vitamin D deficiency. Zinc deficiency can occur in vegans because the phytic acid in whole grains binds zinc, and there is little zinc in fruits and vegetables. Since B12 is present only in animal foods and a limited number of specially fortified foods, vegans should prob- ably take B12 supplements prescribed by a physician. Strict vegetarianism is not desirable for children younger than 5 because it is difficult for vegans to meet children’s high requirements for protein and some other nutrients. Growing adolescents may have difficulty get- ting adequate caloric and nutrient intake from a vegan diet. Vegetarianism is not a good idea for pregnant or lactating women. The American Dietetic Association19 has published a detailed position statement on vegetarian diets.
What Vegetarians Should Eat It is advisable for vegetarians to select a variety of items daily from each of the following groups:
Protein grouP: Dried beans and peas, lentils, nuts, and eggs. grain anD cereal grouP: Whole grain and enriched breads, cereals, pasta, crackers, and other grain products.
fruit anD Vegetable grouP: All fruits and vegetables, includ- ing a citrus fruit daily and a leafy green or bright yellow vegetable every other day.
milK anD milK ProDucts grouP: Milk, yogurt, cheese, and other foods made with milk. This group is especially important for infants, children, and pregnant and nursing women because milk is the single best dietary source of calcium. Those who avoid milk products should give special attention to their intakes of protein, iron, and vitamin B12, as well as calcium and vitamin D.
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“Fast Food” The term “fast food” applies to the speed with which a food is prepared and served rather than the nature or composition of the food. Sometimes these foods are accused of being “junk foods” or of having “empty calories.” Many fast foods are very high in sodium, fats, and calories. Individuals who eat at fast food outlets can satisfy food group and dietary guidelines by including salad selections and other low-fat items.
NutrieNts oF special coNcerN
Certain nutrients should be of special concern to con- sumers. Intakes of iron (Chapter 17), fluoride (Chapter 7), folic acid (folate), calcium, and vitamin D are insuf- ficient and should be increased in some segments of the population. Sodium is consumed in excessive amounts by many people.
Folic Acid Studies have shown that women who have adequate folic acid intake during the months before and after conception have about half the incidence of neural tube defects (NTDs) among their offspring. These birth de- fects include spina bifida and other abnormalities caused by failure of the spinal column to close during the first month after conception, which leaves parts of the spinal cord exposed. To reduce the risk, the U.S. Preventive Services Task Force20 advises all women of childbearing age who are capable of becoming pregnant to consume 400 to 800 μg of folic acid per day. Dietary guidelines for pregnant women are discussed in Chapter 19. Folic acid is found in liver, green leafy vegetables, legumes, wheat germ, yeast, egg yolk, beets, whole wheat bread, fortified cereal, and citrus fruits and juices. It is also added to most enriched grain products. Al- though well-balanced diets provide adequate amounts of folic acid, some women still fall below the recommended amount. In 1993 the FDA approved health claims for supplement labels stating that women who consume enough folate may reduce the risk of having a child with an NTD.
Calcium Calcium, along with fluoride and vitamin D, is essential for the proper formation and maintenance of bones and teeth. Osteoporosis (thinning of the bones) is a common disease in the aged, especially in women (see Chapter 19). Although hormonal problems may be more impor- tant than diet in the development of osteoporosis, the significance of dietary calcium, fluoride, vitamin D, and
weight-bearing exercise should not be overlooked. A 1994 National Institutes of Health Consensus Statement warned that a large percentage of Americans were failing to meet recommended guidelines for optimal calcium intake.21 The currently recommended daily intakes are 700 mg from ages 1–3; 1000 mg from ages 4–8; 1300 mg from ages 9–18; 1000 mg from ages 19–50; 1000 mg for men and 1200 mg for women ages 51–70; and 1200 mg at age 71 and older.22 Milk is the most common source of calcium, but cheese, yogurt, and other foods made with milk also pro- vide significant amounts. Sardines and canned salmon, if eaten with the bones, are rich in calcium. Dark green leafy vegetables such as spinach and broccoli contain some calcium in absorbable form. It is difficult to in- gest adequate amounts of absorbable calcium if dairy products are eliminated from the diet. Women should discuss with their physicians how to ensure adequate intake of calcium through intake of dairy products and/ or supplementation. This is especially important for lactose-intolerant individuals who restrict their intake of milk to avoid the unpleasant symptoms of irregular lactose digestion.
Vitamin D Vitamin D is essential for promoting calcium absorption in the gut and maintaining the blood calcium and phos- phate levels needed for bone growth and maintenance. Together with calcium, vitamin D helps protect older adults from osteoporosis. Vitamin D is naturally present in some foods, added to others, and available as a dietary supplement. It is also produced within the body when ultraviolet rays from sunlight strike the skin. Much recent attention has focused on vitamin D because studies suggest that it may play a major role in the prevention of cancer23 and several other diseases. There has also been widespread concern that Americans are not getting enough.24 However, in 2010, the IOM25 concluded:
• Aside from bone health, current evidence does not support other benefits for vitamin D or calcium intake.
• 600 IUs daily meets the needs of almost everyone in the United States and Canada, although people 71 and older may require as much as 800 IUs per day because of potential physical and behavioral changes related to aging.
• Higher levels have not been shown to confer greater benefits and have been linked to other health problems.
• Whereas the average total intake of Americans is below the median requirement, national surveys show that average blood levels of vitamin D are above the 20 nanograms per milliliter needed for good bone health for practically all individuals.
Chapter Ten Basic Nutrition Concepts 187
• Except for institutionalized elderly and dark-skinned people, most Americans are getting enough vitamin D.
• The number of people with vitamin D deficiency in North America may be overestimated because many laboratories appear to be using standards that are much higher than the IOM committee considers appropriate.
Sodium The relationship of sodium intake to high blood pres- sure (hypertension) is of concern because hypertension is an important risk factor in coronary heart disease and stroke. However, sodium intake has not been proven to cause hypertension to develop.26 Approximately 80% of Americans are not genetically predisposed to hyperten- sion. One-third of the remaining 20% appear to be sensi- tive to sodium; they may be exposed to a higher risk if they consume excess amounts of sodium. Treatment of people with medically diagnosed hypertension will in- clude sodium restriction for those who are salt-sensitive. This subject is discussed in Chapter 15. The average American consumes approximately 10 to 12 g (2 to 2½ teaspoons) of salt per day, of which 3 g occur naturally in foods, 4 to 6 g come from salt or salt-containing ingredients added during food process- ing, and 3 to 4 g is discretionary intake (from the salt shaker). Since salt is about 40% sodium, this amounts to 4 to 5 g of sodium daily. Food labels (see below) list a Daily Value of 2.4 g per day for sodium, the amount contained in 6 g of salt. The National Research Council and various government agencies have concluded that reducing salt intake to 3 g per day (which would require eliminating the use of salt in cooking and at the table) would not be harmful and would improve the health of
the population. However, most people are not harmed by higher levels, and habits, cultural preferences, and culinary customs are difficult to change. Significant amounts of sodium are contained in cured and processed meats, salted snacks, pickled and canned foods, and many frozen convenience foods. Even the small amounts of baking powder, flavor enhancers, and other additives in some foods contain sodium. Many manufacturers have reacted to recent health advice by producing more low-salt and no-salt products. Consum- ers who wish to limit their salt intake should check food labels. Sodium is also present in antacids, laxatives, and other drugstore items. When a household water-softening system replaces calcium (“hardness”) with sodium, having a kitchen faucet reserved for untreated water is another prudent strategy for sodium reduction.
NutritioN laBeliNg
The USDA regulates the labeling of meat and poultry products. The FDA regulates the labeling of nearly all other foods. Modern nutrition labeling began in 1974 when these agencies established voluntary rules requir- ing nutrition information on the labels of products that contained added nutrients or that carried nutrition claims. Since 1993 rules have been published to provide for consistent, scientifically based labeling for nearly all processed foods.27,28 The new rules, which took effect in 1994, provided a basic format for the nutrition panel, which must be titled “Nutrition Facts.” This panel must not only list the significant nutrients in the product, but also must
Nutrient Daily Value
Total fat* 65 g Saturated fat* 20 g Cholesterol* 300 mg Sodium* 2400 mg Potassium* 3500 mg Total carbohydrate* 300 g Fiber* 25 g Protein* 50 g Vitamin A 5000 IU Vitamin C 60 mg Calcium 1000 mg
dailY values (dvs) For Food laBels27
Table 10-3
*Based on 2000 calories a day for adults and children older than 4. The values for total fat, saturated fat, and cholesterol are maximums. The FDA has also issued Daily Values for infants, children younger than 4, and pregnant and lactating women.29
Nutrient Daily Value Iron 18 mg Vitamin D 400 IU Vitamin E 30 IU Vitamin K 80 µg Thiamin 1.5 mg Riboflavin 1.7 mg Niacin 20 mg Vitamin B6 2 mg Folate 400 µg Vitamin B12 6 µg Biotin 300 µg
Nutrient Daily Value Pantothenic acid 10 mg Phosphorus 1000 mg Iodine 150 µg Magnesium 400 mg Zinc 15 mg Selenium 70 µg Copper 2 mg Manganese 2 mg Chromium 120 µg Molybdenum 75 µg Chloride 3400 mg
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indicate how the amounts of certain ingredients are related to recommended levels. These relationships are expressed as “% Daily Values.” Daily Values (DVs) are derived from two sets of reference values: Reference Daily Intakes (RDIs) and Daily Reference Values (DRVs), neither of which ap- pears on the labels themselves. The RDIs cover 12 vitamins and 7 minerals. The DRVs, which are used for fat, carbohydrates, protein, fiber, sodium, and potassium, are based on a diet containing 60% carbohydrate, 10% protein, 30% fat (including 10% saturated fat), and 11.5 g of fiber per 1000 calories. DVs for cholesterol, sodium, and potassium are the same regardless of calorie level. For labeling purposes, Percent Daily Values are based on a diet of 2000 calories. This approximates the maintenance level for many postmenopausal women,
the group most often targeted for weight reduction. Where space permits, the label must include DVs for both 2000- and 2500-calorie diets, and manufacturers are permitted to indicate DVs for other calorie levels. Table 10-3 lists the DVs for adults and children older than 4. Figure 10-2 illustrates the “Nutrition Facts” panel required on most food labels. Other provisions include customary serving sizes and definitions for descriptive terms such as “light,” “low fat,” and “high fiber.” Table 10-4 defines the conditions under which terms such as “light” or “low-fat” are legally permitted. The FDA estimates that about 90% of processed food should carry nutrition information. In addition, uniform point-of-purchase nutrition information should accompany many fresh foods, such as fruits, vegetables,
% Daily Value shows how a food fits into the over- all daily diet. Some daily values are maximums, as with fat, whereas others are minimums, as with carbohydrates.
The Daily Values are based on daily diets of 2000 and 2500 calories. Individuals should adjust these values to fit their own calorie intake. (Moderately active people consume about 15 calories per day for each pound of body weight.)
The nutrients required on the nutrition panel are those considered most important to the health of today’s consumers, most of whom need to be concerned about getting too much of certain items (such as saturated and trans fat) rather than too few (as was the case years ago with certain vitamins).
Serving sizes, stated in both household and metric measures, reflect the amounts that people actu- ally eat.
Calories from fat are shown to help consumers meet dietary guidelines, which recommend that people get no more than 30% of their calories from fat, with satu- rated and trans-fats kept as low as possible.
Figure 10-2. Sample food label.
Fats, carbohydrates, and proteins provide energy (calories).
Nutrition Facts Serving Size 1 cup (228g) Servings Per Container 2
Amount Per Serving
Calories 250 Calories from Fat 110
% Daily Value*
Total Fat 12g Saturated Fat 3g Trans Fat 3g Cholesterol 30 mg Sodium 470mg Total Carbohydrate 31g Dietary Fiber 0g Sugars 5g Protein 5g
Vitamin A Vitamin C Calcium Iron * Percent Daily Values are based on a 2,000 calorie diet. Your Daily Values may be higher or lower depending on your calorie needs.
Calories: 2,000 2,500
Total Fat Less than 65g 80g Sat Fat Less than 20g 25g Cholesterol Less than 300mg 300mg Sodium Less than 2,400mg 2,400mg Total Carbohydrate 300g 357g Dietary Fiber 25g 30g
18% 15%
10% 20% 10%
0%
4% 2%
20% 4%
Chapter Ten Basic Nutrition Concepts 189
free or without: An amount that is nutritionally trivial and unlikely to have a physiological consequence.
calorie free: Fewer than 5 calories per serving. sugar free: Less than 0.5 g per serving of monosaccharides and/or disaccharides.
soDium free or salt free: Less than 5 mg per serving. A claim made for a food normally free of or low in a nutrient must indicate that the situation exists for all similar foods. For example: “spinach: a low-sodium food.” Labels of foods containing insignificant amounts of ingredients (such as baking soda or sodium ascorbate) commonly understood to contain sodium must use an asterisk to refer to a note below the ingredient list that the amount of added sodium is trivial.
low or little: Low enough to allow frequent consumption without exceeding the dietary guidelines. Generally less than 2% of the Daily Value for the nutrient. A claim of “very low” can be made only about sodium.
low calorie: Fewer than 40 calories per serving and per 100 g of food. May be used for meal-type products with 120 calories per 100 g of food.
light (or lite): Contains one-third fewer calories than the ref- erenced food. Products deriving more than half their calo- ries from fat must have their fat content reduced by 50% or more with a minimum reduction of more than 3 g per serving. The percentage of reduction of calories and/or fat must be specified immediately proximal to the claim. May not be used for foods or nutrients meeting the requirements for a “low” claim. The term “light” can be used for a salt substitute if it contains at least 50% less sodium than ordi- nary table salt. Other use of “light” must specify whether it refers to look, taste, or odor, unless the meaning of the term is obvious and fundamental to the product’s identity. (Thus, light brown sugar would require no explanation).
less (or fewer), lower, or reDuceD: Contains at least 25% less of a nutrient (or calories) than the referenced food. May not be used for foods or nutrients meeting the requirements for a “low” claim.
more: Contains at least 10% more of a desirable nutrient than does a comparable food. The terms “fortified,” “en- riched,” or “added” may be used instead under appropriate circumstances. Use limited to vitamins, minerals, protein, dietary fiber, and potassium.
high, rich in, or excellent source: Contains 20% or more of the DRV per serving.
gooD source: Contains 10% to 19% of the DRV. Can also be described as “contains” or “provides.”
fat free: Less than 0.5 g of fat per reference amount and serving size, and no added ingredient that is a fat or oil. The term “fat free” may not be used for a food that is inher- ently free of fat unless there is an accompanying statement that all foods of this type are inherently fat free. Labels of foods containing insignificant amounts of ingredients (such as nuts) commonly understood to contain fats are permitted to note that the amount of added fat is trivial.
(Percent) fat free: Permissible only for foods that meet the FDA definition of low fat. (Note that the fat percentage is determined by weight, not calories.)
legal deFiNitioNs oF descriptive terMs For Food laBels28 Table 10-4
low fat: Contains 3 g or less of fat per reference amount, per serving size, and per 100 g of product. May not be used for foods inherently low in fat unless accompanied by a disclaimer that all foods of this type are inherently low in fat. May be applied to meal-type products if the meals also derive 30% or fewer of their calories from fat.
reDuceD or less fat: Reduced fat content by 25% or more, with at least 3 g less per reference amount and per serving size.
saturateD fat free: May be used for all products that are fat free. Labels of products that are not fat free but contain less than 0.5 g of saturated fat per reference amount must disclose the amount of total fat.
low in saturateD fat: 1 g or less per serving, with not more than 15% of calories from saturated fat and 1% or less of total fat as trans-fatty acids. Labels of foods containing insignificant amounts of ingredients commonly understood to contain saturated fats must state that the amount of satu- rated fat is trivial. Meal-type products must also derive less than 10% of their calories from saturated fat.
reDuceD or less saturateD fat: At least 25% less saturated fat per serving than the reference food. When these terms are used the label must indicate the percent reduction and the amount of saturated fat in the reference food. The reduction must be at least 1 g.
cholesterol free: Less than 2 mg of cholesterol and 2 g or less of saturated fat per serving. Labels of foods containing insignificant amounts of ingredients commonly understood to contain cholesterol must state that the amount of choles- terol is trivial.
low in cholesterol: 20 mg or less per serving and per 100 g of food, and 2 g or less of saturated fat per serving.
reDuceD or less cholesterol: At least 25% less cholesterol per serving than its comparison food. The label of a food containing more than 13 g of total fat per serving or per 100 g of the food must disclose that fact.
low soDium: Less than 140 mg per serving and per 100 g of food (a little less than half a cup).
Very low soDium: Less than 35 mg per serving and per 100 g of food.
light in soDium: Contains at least 50% less sodium than an appropriate comparison food.
fresh: Can only be linked to raw food, food that has not been frozen, heated, processed, or preserved. (Low-level irradia- tion is permissible.)
freshly: Can be used with a verb such as “prepared,” “baked,” or “roasted” if the food is recently made and has not been heat-processed or preserved. “Freshly frozen” may be used for foods that are quickly frozen while fresh.
lean: Meat or poultry product with less than 10 g of fat, less than 4.5 g of saturated fat, and less than 95 mg of choles- terol per 100 g.
extra lean: Meat or poultry product with less than 5 g of fat, less than 2 g of saturated fat, and less than 95 mg of choles- terol per 100 g.
antioxiDant claims: Nutrient must have established RDI and scientific evidence of antioxidant activity. Level must meet definition of “high,” “good source,” or “more.”
© 2011, Stephen Barrett, M.D.
Part Three Nutrition and Fitness190
fruits anD Vegetables anD cancer
Low-fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C and is a good source of dietary fiber.
fiber-containing grain ProDucts, fruits, anD Vegetables anD cancer
Low-fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors.
Dietary fat anD cancer
Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.
calcium anD osteoPorosis
Regular exercise and a healthy diet with enough calcium help teen and young adult white and Asian women maintain good bone health and may reduce their risk of osteoporosis later in life.
Dietary sugar alcohol anD Dental caries
Full claim: Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in [name of food] do not promote tooth decay. Shortened claim (on small packages only): Does not promote tooth decay.
Dietary saturateD fat anD cholesterol anD risK of coronary heart Disease
While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.
fruits, Vegetables, anD grain ProDucts that
contain fiber, Particularly soluble fiber, anD risK of coronary heart Disease
Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may re- duce the risk of heart disease, a disease associated with many factors.
soluble fiber from certain fooDs anD risK of coronary heart Disease Soluble fiber from foods such as [name of soluble fiber source, and, if desired, name of food product], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food product] supplies __ grams of the [necessary daily dietary intake for the benefit] soluble fiber from [name of soluble fiber source] necessary per day to have this effect.
soy Proteins anD heart Disease
(1) 25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of soy protein.
(2) Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides __ grams of soy protein.
Plant sterol anD stanol esters anD coronary heart Disease
(1) Foods containing at least 0.65 gram per of vegetable oil sterol esters, eaten twice a day with meals for a daily total intake of least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of vegetable oil sterol esters.
(2) Diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals may reduce the risk of heart disease. A serving of [name of food] supplies __ grams of plant stanol esters.
soDium anD hyPertension
Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.
folate anD neural tube Defects
Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord defect.
uNqualiFied health claiMs perMissiBle iN Food laBeliNg
Table 10-5
Manufacturers who want to use wording that differs from the FDA’s model claims can petition for FDA approval. Although preapproval is not required, claims that are not preapproved can trigger regulatory action if the FDA considers them misleading.
raw fish, meat, and poultry. Although this is voluntary, it will be mandated if fewer than 60% of retailers fail to comply voluntarily. Similar labeling rules may be proposed for restaurant, delicatessen, and institutional foods.
Approved Health Claims A “health claim” is defined as any type of communi- cation in labeling that is intended to suggest “a direct beneficial relationship between the presence or level of any substance in the food and a health or disease-related
Chapter Ten Basic Nutrition Concepts 191
condition.” If the FDA approves a claim, it issues model claims that sellers are free to modify as long as the mean- ing does not change. Health claims are permissible only if (a) a food substance is associated with a disease- or health-related condition for which the general U.S. population or an identified subgroup is at risk, (b) the claim is made in the context of the product’s relationship to overall diet, and (c) the claim is supported by publicly available sci- entific evidence (including well-designed and properly conducted experiments). In addition, the claims must be “complete, truthful, and not misleading.” Any claim that a single food (as opposed to overall dietary composition) or food component (such as a vitamin, mineral, or other entity portrayed as a dietary supplement) can prevent, cure, mitigate, or treat a disease or symptom would render the product subject to regulation as a drug and would not be appropriate for labeling of a food. Three types of food-related health claims are permitted:
unqualifieD claims must be based on “significant agreement” among qualified experts that the claims are supported by solid evidence.30 Table 10-5 lists these claims.
qualifieD claims can be based on less scientific support, as long as the labeling provides an appropriate perspective. The labeling can state that there is evidence of benefit but must add that the evidence is limited or not conclusive and, in some cases, it must mention that the FDA does not endorse the claim. Qualified claims are permissible for selenium and cancer; antioxidant vitamins and cancer; nuts and heart disease; walnuts and heart disease; omega-3 fatty acids and coronary heart disease; olive oil and coronary heart disease; unsaturated fats from canola oil and coronary heart disease; green tea and cancer; chromium picolinate and diabetes; B vitamins and vascular disease; calcium and colon/rectal cancer and recurrent colon/rectal polyps; calcium and phos- phatidylserine and cognitive function and dementia; corn oil products and heart disease; and 0.8 mg of folic acid and neural tube birth defects.31
fDama claims. The Food and Drug Administration Moderniza- tion Act of 1997 permits manufacturers to seek approval for claims that are based on authoritative statements by federal scientific bodies. The four health claims that have been approved so far must be worded exactly as follows: • “Diets containing foods that are a good source of potas- sium and that are low in sodium may reduce the risk of high blood pressure and stroke.”
• “Drinking fluoridated water may reduce the risk of [dental caries or tooth decay].”
• “Diets rich in whole grain foods and other plant foods and low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers.”
• “Diets low in saturated fat and cholesterol, and as low as possible in trans fat, may reduce the risk of heart disease.”
Most people who follow the Dietary Guidelines for Americans will get adequate amounts of the nutrients for which claims are permissible. Thus the principal (if any) value of the health claims may be to remind consumers that since many substances may promote health, eating a wide variety of foods is a good idea.
trustworthY iNForMatioN sources
The dissemination of nutrition advice is poorly regulated by law. For this reason, consumers seeking nutrition advice should be very careful in selecting their advisers. Trustworthy information can be obtained from nutrition or medical professionals, professional organizations, and publications identified in the remainder of this chapter and in the Appendix. Untrustworthy sources are identi- fied in. Your primary care provider is probably the most convenient person from whom to obtain advice on nutrition. Medical doctors are often criticized for not knowing enough about nutrition. The American Council on Science and Health disagrees32:
Not all physicians are nutrition experts, just as not all are specialists in cardiology or community medicine. However, the practicing physician has sufficient knowledge of the bio- chemical and physiological principles of nutrition, and has access to many resources which can aid in answering patients’ questions. Most people who read about a “new nutritional discovery” don’t have enough knowledge to figure out whether it’s a real scientific development or a piece of quack nonsense. Physicians do have the expertise to make this kind of judgment
√ Consumer Tip
Many organizations evaluate and publish accurate in- formation about nutrition. Some communicate primarily with health and nutrition professionals, whereas others primarily serve the public. The following organizations are generally trustworthy:
Academy of Nutrition and Dietetics American Council on Science and Health American Medical Association American Society for Nutrition Council on Agricultural Science and Technology International Food Information Council Institute of Food Technologists International Life Sciences Institute National Center for Nutrition and Dietetics Quackwatch USDA Food and Nutrition Information Center U.S. Food and Drug Administration
Part Three Nutrition and Fitness192
and to evaluate the technical research on which popular reports are based. If you have a question that your doctor can’t answer, he or she can refer you to someone who can.
Nutrition Professionals Many accredited colleges and universities offer nutri- tion courses based on scientific principles and taught by qualified instructors. A bachelor’s degree requires 4 years of full-time study that qualify a graduate for entry-level positions in dietetics or foodservice, often in a hospital. A master’s degree in nutrition requires 2 more years of full- time study beyond the undergraduate level. People who wish to become nutrition researchers usually pursue a Ph.D. in biochemistry. This requires at least 2 more years of study plus a dissertation based on original laboratory research. Those wishing to concentrate on teaching or educational research usually seek a degree of Ph.D. or Ed.D. in nutrition education. With few exceptions, a nutrition-related degree from an accredited university signifies a broad background in nutrition science and a thorough grasp of nutritional concepts. In addition to an academic degree, most serious nutrition professionals seek professional certification. Regular membership in the American Society for Nu- trition (ASN) is open to individuals with an accredited doctoral level degree in nutrition or a related field who have published meritorious original research on some aspect of nutrition. Individuals with lesser degrees who are committed to nutrition research or have demonstrated leadership as an educator or administrator are eligible to apply for associate membership. These requirements, plus an enforceable code of professional responsibility, make it unlikely that a promoter of quackery will become (or remain) an ASN member. Physicians who have specialized nutrition training can be certified by the American Board of Physician Nutrition Specialists. This requires passage of written and oral examinations on a wide range of topics. Most certified nutrition specialists are affiliated with medical schools and hospitals, where they conduct clinical re- search and offer consultation to primary-care physicians. Registered dietitians (R.D.s) are specially trained to translate nutrition research into appropriate diets. Compared to physicians, they usually know less about basic biochemistry, physiology, and metabolism, but more about dietary assessment, nutrition counseling, and the nutrient content of specific foods. The requirements include an accredited degree in nutrition, appropriate clinical experience, and passage of a written test that covers all aspects of nutrition and foodservice manage- ment. The Commission on Dietetic Registration, which
administers the registration/certification process, also certifies advanced-level practitioners and specialists in renal (kidney), pediatric, metabolic, sports, and oncology (cancer) nutrition. Many of the country’s 60,000 active R.D.s work in hospitals where they counsel patients and conduct classes for pregnant women; heart, kidney and AIDS patients; diabetics; and other people with special dietary needs. Dietitians also work at community agencies such as geriatric, day care, and drug/alcohol abuse centers. Some dietitians do research. Others are in private prac- tice where they counsel physician-referred patients. The ADA’s consumer hotline (800-366-1655) provides recorded nutrition messages and referrals to local R.D.s The Certification Board for Nutritional Specialists offers a Certified Nutrition Specialist (CNS) credential to professionals with an accredited master’s or doctoral degree who have clinical experience and pass an ex- amination. Its requirements are substantial but less than those of the ASN. Nearly all states have enacted laws to license or certify dietitians and/or nutritionists.33 Some of these laws restrict the use of titles, whereas others restrict who is permitted to do nutritional assessment and counsel- ing. Although holding such a credential is a good sign, in some states the standards are not high enough to prevent unqualified individuals from becoming licensed. The initials “L.D.” stand for licensed dietitian. In many states, no law exists to prevent unqualified persons from representing themselves as nutritionists. For this reason, those who use this term should be regarded with caution (see Chapter 11).
Other Sources The National Institute for Dental Research, National Institute of Allergy and Infectious Diseases, National Cancer Institute, and National Institute of Arthritis, Metabolism and Digestive and Kidney Diseases all have educational material about nutrition as it applies to their areas of interest.
1. You plan to obtain a quick dinner at a fast food outlet. How can you ensure a nutritious food intake?
2. You have heard that many Americans are not eating properly. How can you check whether your diet con- tains adequate amounts of all the nutrients you need? If you are not sure what to do, how can you locate a professional person to help you?
It’s Your Decision
Chapter Ten Basic Nutrition Concepts 193
State and local dietetic associations are usually eager to be helpful. Dial-A-Dietitian services to answer tele- phone inquiries are available in some cities. Other local sources include accredited colleges and medical schools, USDA Extension Services of land-grant universities, home economists at USDA county cooperative services (for information on food preparation), state health de- partments, some local health departments, and state or county medical societies. Available local sources are list- ed in the Yellow or Blue Pages of the telephone directory and on the Internet. The American Dental Association and several other organizations listed in the Appendix provide information about nutrition as it applies to their areas of special interest. Chapter 2 identifies newsletters that provide trustworthy nutrition information.
suMMarY
The basic principles of nutrition are moderation, variety, and balance. These can be achieved by daily selection of appropriate numbers of moderate-sized portions from each of the food groups. The Internet-based Food Guidance System enables consumers to select foods from groups rather than having to calculate the amount of each nutrient in each individual portion of food. The Dietary Guidelines for Americans provide additional advice about moderating dietary fat (to help prevent heart disease) and consuming adequate amounts of fiber. Nutrition labeling enables consumers to ascertain the nutrient contents of most foods. Vitamin deficiencies are uncommon in the United States, but many women do not consume enough iron or calcium in their diet. Vegetarian diets can be a health- ful alternative to those that include meat, but they must be constructed carefully to avoid nutrient deficiencies. Many qualified professionals can provide trustworthy information and advice about diet and nutrition.
reFereNces
1. Derelian D. Foreword to the American Dietetic Association 1995 Nutrition Trends Survey. Chicago, 1995, The Association.
2. Herbert V, Kasdan TS. What is a healthy food plan? In Herbert V, Subak-Sharpe GJ, editors. Total Nutrition: The Only Guide You’ll Ever Need. New York, 1995, St. Martin’s Press.
3. Revealing trans fats. FDA Consumer 37(5):20–26, 2003. 4. Stare F, Aronson V, Barrett S. Your Guide to Good Nutrition.
Amherst, N.Y., 1991, Prometheus Books. 5. Koop CE. The Surgeon General’s Report on Nutrition and
Health. DHHS (PHS) Publication No. 88-50210. Washington, D.C., 1988, Superintendent of Documents.
6. Anderson JW and others. Health benefits of dietary fiber. Nutri- tion Reviews 67:188–205, 2009.
7. Pilch SM and others. Physiological Effects and Health
Consequences of Dietary Fiber. Washington, D.C., 1987, Fed- eration of American Societies for Experimental Biology.
8. Appendix E-4: History of the Dietary Guidelines for Americans. Van Horn LV and others. Report of the Dietary Advisory Com- mittee on the Dietary Guidelines for Americans, 2010. USDA Web site, June 2010.
9. U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2010. 7th Edition, Washington, D.C., 2010, U.S. Government Printing Office.
10. Food and Nutrition Board. Dietary Reference Intakes for: Cal- cium, Phosphorus, Magnesium, Vitamin D, and Fluoride (1997); Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline (1998); Vitamin C, Vita- min E, Selenium and Carotenoids (2000); Vitamin C, Vitamin E, Selenium, and Carotenoids (2000); Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc (2002); Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (2002); Energy, Carbohydrate, Fi- ber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients) (2002); Water, Potassium, Sodium, Chloride, and Sulfate (2004); Calcium and Vitamin D (2010). Washington, D.C., National Academy Press.
11. Sims LS. Uses of the Recommended Dietary Allowances: A commentary. Journal of the American Dietetic Association 96:659–662, 1996.
12. Herbert V, Barrett S. The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods. Amherst, N.Y., 1994, Prometheus Books.
13. Welsh S and others. A brief history of food guides in the United States. Nutrition Today 27(6):6–11, 1992.
14. AAP Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics 115:496–506, 2005.
15. Guidance for industry: Frequently asked questions about FDA’s regulation of infant formula. FDA Web site, March 1, 2006.
16. Butte N and others. The Start Healthy Guidelines for Infants and Toddlers. Journal of the American Dietetic Association 104:442–454, 2004.
17. Effects of early nutritional interventions in the development of atopic disease in infants and children: The role of maternal dietary restriction, breastfeeding, timing of introduction of complementary foods, and hydrolyzed formulas. Pediatrics 121:183–191, 2008.
18. Jarvis WT. Why I am not a vegetarian. Priorities 9(2):32–43, 1997. 19. Position of the American Dietetic Association: Vegetarian diets.
Journal of the American Dietetic Association 109:1266–1282, 2009. 20. Folic acid to prevent neural tube defects. US Preventive Services
Task Force Web site, May 2009. 21. Optimal calcium intake. NIH Consensus Statement 12(4):1–31, 1994. 22. Dietary supplement fact sheet: Calcium. NIH Office of Dietary
Supplements Web site, accessed Nov 19, 2010. 23. Garland CF. The role of vitamin D in cancer prevention. Ameri-
can Journal of Public Health 96:252–261, 2006. 24. The ABCs of vitamin D: How much do you really need, and
what’s the best way to to get it? Consumer Reports on Health 21:(11):1,4–5, 2009.
25. Food and Nutrition Board. Dietary Reference Intakes for: Calcium and Vitamin D. Washington, D.C., 2010, National Academy Press.
26. Midgley JP and others. Effect of reduced dietary sodium on blood pressure: A meta-analysis of randomized controlled trials. JAMA 275:1590–1597, 1996.
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27. Food and Drug Administration. Food labeling. Federal Register 58(3):631–691, 2065–2964, 1993. (Updated summary in The food label. FDA Backgrounder BG-99-5, May 1999).
28. Food Labeling Guide. FDA Center for Food Safety and Nutrition Web site, revised Oct 2009.
29. Appendix G: Daily Values for infants, children less than 4 years of age, and pregnant and lactating women. FDA Web site, Oct 2009.
30. Health claims that meet significant scientific agreement. FDA Web site, accessed April 16, 2005.
31. Summary of qualified health claims permitted. FDA Web site, accessed April 16, 2005.
32. Meister KA. How much does your doctor know about nutrition? ACSH News & Views 1(6):4–5, 1980.
33. State licensure agency list. ADA Commission on Dietetic Reg- istration Web site, accessed Nov 18, 2010.
NutritioN Fads, Fallacies,
aNd scams
Nutrition seems to be like politics: everyone is an expert. Harold J. Morowitz, PH.d.1
The very term “health food” is a deceptive slogan. All food is health food in moderation; any food is junk food in excess. Did you ever stop to think that your corner grocery, fruit market, meat market, and supermarket are also health-food stores? They are—and they generally charge less than stores that use the slogan. Victor Herbert, M.d., J.d.2
© 1996. reproduced by permission of johnny hart and creators syndicate, inc.
Chapter Eleven
Part Three Nutrition and Fitness196
Erroneous nutrition concepts lead Americans to waste billions of dollars annually and sometimes to jeopardize their health. Most Americans prob-
ably are harmed to some degree by nutrition fads and fallacies. At the core of this problem are individuals and groups whose collective efforts can be referred to as the health-food industry. However, pharmaceutical manufac- turers and large food companies also foster and exploit public confusion about nutrition. This chapter illustrates how misinformation is used to promote vitamin and mineral supplements, “health foods,” “organic” foods, “natural” foods, herbs, related products, and dietary fads. This chapter also discusses the activities and back- grounds of some of the leading promoters of nutrition misinformation. Facts and fads related to weight control are covered in the next chapter.
Food Faddism aNd Quackery
Schafer and Yetley3 have defined food faddism as an un- usual, enthusiastically adopted pattern of food behavior in which foods are used with the hope of achieving a stable and predictable life pattern. Faddist beliefs may include: (a) specific foods or food groups have special curative properties and therefore should be primary constituents of an individual’s diet, (b) certain foods are harmful and should be avoided, (c) “natural” foods should be emphasized, and (d) certain foods should be emphasized to express a particular lifestyle.3,4 Olson5 has noted that food faddism persists because food has an emotional rather than an intellectual value to the average person. Beal6 has classified eight types of food faddists, as shown in Table 11-1.
keep these poiNts iN miNd as you study this chapter
• Most people who take vitamin supplements for “insurance” don’t need them.
• Most dietary supplement and herbal products have no rational purpose, and some are dangerous.
• The vast majority of marketers of dietary supplements and herbal products do not give trustworthy advice.
• The keys to avoiding nutrition quackery are to recognize common fads and fallacies and to rely on trustworthy sources of information.
Key Concepts
From Beal VA: Food faddism and organic and natural foods. Reprinted courtesy of the American Dietetic Association.6
Type of Faddist Miracle-seeker
Anti-establishmentarian
Super health-seeker
Distruster of medical profession
Fashion-follower Authority-seeker
Truth-seeker One concerned about uncertain-
ties of living
Need Served by Fad
Patterning need to establish stability regarding health, energy, and so on. Ac- complished by diets intended to forestall aging or restore organism to health. Ego defense need to re-establish positive self-concept and feeling of self- worth.
Self-realization need to express self in a manner consistent with self-concept and value system.
Ego defense need to forestall aging process. Accomplished by diet intended to give super health. Self-realization need to present front of strength and health.
Ego defense need to establish control over own destiny and not be dependent on unknown others.
Ego defense and patterning need to establish an identity to gain approval and acceptance from others.
Self-realization need for recognition of self-competency, provided by apparent knowledge in area of food information.
Patterning need to process existing claims concerning nutrition. Patterning need for anchors and stability concerning the world.
emotioNal Needs oF Food Faddists
Table 11–1
Chapter Eleven Nutrition Fads, Fallacies, and Scams 197
Many faddists use propaganda techniques that play on people’s fears, hopes, and prejudices. One technique is to make the respondent hate a perceived enemy and love and support a cause. Many aspects of food fad- dism become social movements that represent symbolic rebellions against authority, society at large, or some imagined enemy. Whorton8 suggests that the term fad- dism is misleading because it connotes little more than temporary foolishness. Instead, he suggests, the high levels of devotion, asceticism, and zeal associated with certain health ideologies make it more appropriate to call them “hygienic religions.” Bratman9 has coined the term “orthorexia nervosa” (also called orthorexia) to describe people who become so obsessed with food “purity” and quality and adopt dietary restrictions so stringent that they plan their life around food and may suffer social and health problems. Promoters of nutrition quackery are skilled at arous- ing and exploiting fears and false hopes. Four basic
myths are used to encourage the use of “health foods” and dietary supplements:
1. It is difficult, if not impossible, to get the nourishment you need from ordinary foods.
2. Vitamin and mineral deficiencies are common. 3. Virtually all diseases are caused by faulty diet. 4. Virtually all diseases can be prevented or remedied
nutritionally.
Table 11-2 lists 30 misleading statements used by “vitamin pushers” and food quacks. The “Science of Foolology” box on page 198 recounts how a fictional character anticipated some of these approaches a century ago.
dietary supplemeNts
In ordinary use the terms “dietary supplement” and “food supplement” refer to any food substance, or mixture of such substances, consumed in addition to or in place of
1. When talking about nutrients, they tell only part of the relevant story.
2. They claim that most Americans are poorly nour- ished.
3. They recommend “nutrition insurance” for every- one.
4. They say that if you eat badly, you’ll be OK as long as you take supplements.
5. They say that most diseases are due to faulty diet and can be treated with “nutritional” methods.
6. They allege that modern processing methods and storage remove all nutritive value from our food.
7. They claim that diet is a major factor in behavior. 8. They oppose fluoridation of water and pasteuriza-
tion of milk. 9. They claim that soil depletion and the use of pesti-
cides and “chemical” fertilizers result in food that is less safe and less nourishing.
10. They claim you are in danger of being “poisoned” by ordinary food additives and preservatives.
11. They charge that the recommended dietary allow- ances (RDAs) have been set too low.
12. They claim that under stress, and in certain dis- eases, your need for nutrients is increased.
13. They recommend “supplements” and “health foods” for everyone.
14. They say it is easy to lose weight.
15. They claim that sugar is a deadly poison. 16. They claim that everyone needs to be detoxified. 17. They recommend a wide variety of substances
similar to those found in your body. 18. They claim that “natural” vitamins are better than
“synthetic” ones. 19. They suggest that a questionnaire can be used to
indicate whether you need dietary supplements. 20. They promise quick, dramatic, miraculous results. 21. They routinely sell vitamins and other “dietary
supplements” as part of their practice. 22. They use disclaimers couched in pseudomedical
jargon. 23. They use anecdotes and testimonials to support
their claims. 24. They offer phony “vitamins.” 25. They display credentials not recognized by respon-
sible scientists or educators. 26. They offer to determine your body’s nutritional
state with a single laboratory test. 27. They claim they are being persecuted by orthodox
medicine and that their work is being suppressed because it’s controversial.
28. They warn you not to trust your doctor. 29. They sue or libel their critics. 30. They encourage patients to lend political support to
their treatment methods.
30 tips to help spot VitamiN pushers aNd Food Quacks
Table 11-2
Modified from Barrett S, Herbert V. The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods.7
Part Three Nutrition and Fitness198
food. The most commonly used supplements are vita- mins and minerals.11 Many products sold as supplements contain substances not needed in the human diet. It is not legal to market any product with therapeu- tic claims unless satisfactory evidence of safety and effectiveness is presented to the FDA. However, many products are marketed as “dietary supplements” even though they are nutritionally insignificant or are intended for treating a health problem. Intended therapeutic uses seldom appear on product labels but are communicated in other ways to retailers and prospective customers. Thus, although customers are led to believe that various “supplements” can function as effective drugs, the FDA cannot regulate them as drugs. The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines “dietary supplement” as any product (except tobacco) that contains at least one of the following: (a) a vitamin, (b) a mineral, (c) an herb or other botanical, (d) an amino acid, (e) a dietary substance “for use to supplement the diet by increasing total dietary intake,” or (f) any concentrate, metabolite, constituent, extract, or combination of any of the afore- mentioned ingredients. Herbal supplements, of course, are not consumed for a nutritional purpose and often are marketed with therapeutic claims. The supplement
industry, which lobbied vigorously for passage of this act, included them in this definition to weaken the FDA’s ability to regulate their marketing. Although herbal supplement products can properly be viewed as “drugs in disguise,” they are discussed in this chapter rather than the drug chapter because their marketing and regulation differ considerably from that of real drugs. Spices and other products intended for use as flavoring agents are not within DSHEA’s scope. DSHEA enables marketers to state how their prod- ucts may influence body structure or function as long as they do not relate this to the prevention or treatment of a disease. All such statements must be accompanied by a disclaimer that they have not been evaluated by the FDA and that the product is not intended to “diagnose, treat, cure, or prevent any disease.”12 Structure/function claims have little or no practical value because even if they are literally true, they cannot specify or explain who might benefit from taking the product. They should be regarded as a sales gimmick written into the law by Congressional representatives who wanted to enable supplement marketers to suggest intended uses without getting into trouble. Vitamins are sold individually and combined with other vitamins and/or minerals. Multivitamin-mineral combinations may contain as many as 60 ingredients, but some ingredients, such as bioflavonoids, inositol, rutin, and para-aminobenzoic acid (PABA), are not nutrients and are not needed in the human diet. Herbs are sold individually, in herbal mixtures, and combined with vitamins, minerals, and/or amino acids. The variety of products sold as dietary supplements (including many that contain no essential nutrients) is huge. Altogether, several hundred companies market more than 50,000 such products. Nutrition Business Journal13 estimates that in 2009 Americans spent over $27 billion for supplement and herbal products. Most people who use multivitamins think they are getting “nutrition insurance,” but many erroneously believe that extra vitamins can provide ex- tra energy, improve general health, and protect against stress. Most who supplement with individual nutrients believe that these products have medicinal value. In a 1999 survey, users of vitamin and mineral supplements, herbs, and “specialty supplements” said they took them to ensure good health; improve energy or stamina; pre- vent or treat common illnesses like colds and the flu; improve memory or mental sharpness; prevent or treat more serious medical conditions; reduce anxiety, stress, or tension; slow down the aging process; improve mood or alleviate depression; lose weight or control appetite;
The Science of Foolology10
One evening at Mory’s, Dink Stover sits listening to Ricky Rickets discourse on how he plans to become a millionaire in 10 years. That certain route to wealth lies in “making an exact science” of beguiling the foolish. “What’s the principle of a patent medicine?” Ricky asks rhetorically, and then answers himself. “Advertise first, then concoct your medicine.” “All the science of Foolology,” he elaborates, “is: first, find something all the fools love and enjoy, tell them it’s wrong, hammer it into them, give them a substitute and sit back, chuckle, and shovel away the ducats. Why, Dink, in the next 20 years all the fools will be feeding on substitutes for everything they want . . . and blessing the name of the foolmaster who fooled them.” Ricky’s prediction [made in a fictional work published in 1912!] contained much truth. Many blessings, and ducats too, have enriched critics of the regular diet who have provided some substitute promoted to preserve and restore health. James Harvey Young, Ph.D.
Historical Perspective
Chapter Eleven Nutrition Fads, Fallacies, and Scams 199
improve sexual function or pleasure; and/or help with menopause (women only).14
Multivitamins vary greatly in the types and amounts of their individual ingredients. Many products contain amounts that exceed the RDA. Vitamin A is present in amounts up to 25,000 IU (international units), or five times its RDA; vitamin D is present in amounts up to 5000 IU, 121/2 times its RDA; vitamin B6 as high as 500 mg, 250 times the RDA; vitamin E up to 1000 IU, 100 times its RDA; and vitamin C up to 1000 mg, 11 times its RDA. Single supplement tablets of vitamin C may contain as much as 2000 mg. Dosages this high are un- necessary, costly, and sometimes harmful. Most mineral supplements contain below-RDA amounts, but a few contain slightly more. Several scientific and professional groups have recommended that the FDA limit the dosage of certain ingredients in over-the-counter (OTC) vitamin and min- eral products. However, the Proxmire Amendment to the Food, Drug, and Cosmetic Act prevents the agency from regulating the dosages of vitamin products that are not inherently dangerous. The amendment was passed in 1976 after a massive lobbying campaign spearheaded by the health-food industry.15
Curiously, the American public is not highly con- fident that dietary supplements are safe or accurately labeled. A 1999 survey found that (a) only 41% were very confident about the safety of vitamin and mineral supplements, (b) 34% believed the information on the labels was very accurate, (c) 24% were very confident that herbal products are safe, (d) and 32% believed herbal products were very accurately labeled. In addition, 12%
of herbal product and 13% of specialty supplement users experienced adverse reactions to these products.14
“Nutrition Insurance” Most nutrition authorities agree that healthy individuals can get all the nutrients they need by eating sensibly. Most Americans believe this, too, but many worry that their eating habits place them at risk for deficiency. The fear of not getting enough nutrients is promoted vigorously, not only by food faddists and health-food industry publicists, but also by major pharmaceutical manufacturers and trade associations. Faddists tend to stress unscientific ideas that people cannot get sufficient nourishment from ordinary foods, while the drug com- panies use more subtle suggestions that various people may not be getting enough. Both groups fail to suggest how to obtain nutrients from foods or how to tell whether you are getting enough. Dr. Paul Thomas,16 a former staff scientist for the Food and Nutrition Board, says that tak- ing supplements is more like gambling than insurance (see Personal Glimpse box). One of the main arguments used to support recom- mendations for “insurance” by vitamin supplements is that reputable health and nutrition surveys have found that intakes of some vitamins by some segments of the population are below the RDAs. Dr. Alfred E. Harper,17 a former chairman of the Food and Nutrition Board, has explained why the above argument is misleading:
• The RDAs are set high enough to encompass the needs of individuals with the highest requirements. Using them directly as standards for evaluating the adequacy of indi- vidual nutrient intakes would be like setting the standard for a person’s height at 7 feet and concluding that all those under 7 feet have suffered growth retardation.
• Surveys often identify vitamin A as a “problem nutrient.” However, when the results of dietary surveys are based on measurements of nutrient intakes for a single day, many people who consume adequate amounts of vitamin A over a longer period of time are classified as having a “low” intake. Since vitamin A is stored efficiently in the liver, a surplus consumed on one day will provide a reserve that is available on subsequent days.
Another factor in the low values found in surveys is that people tend to under-report the amount they eat.
Even under highly controlled conditions, the under- reporting of caloric intake can be nearly 20%.18
The best strategy for people worried about the ad- equacy of their diet is to monitor and evaluate what they eat in a typical week. As explained in Chapter 10, indi- viduals can do this on the MyPlate.gov Web site or can consult a physician or registered dietitian. If a problem
Nutrition Insurance or Nutrition Roulette? Those who recommend that healthy people supplement their diet with extra vitamins and minerals often call it a form of dietary insurance. I disagree. When you purchase insurance, the benefits and costs of the policy are detailed and you choose a specific level of protec- tion. The terms of a dietary insurance policy, though, can never be known, much less specified. Taking supplements without a clear need is more analogous to playing the lottery. You hope to win some money, and ideally the jackpot, by buying lottery tickets. You won’t hurt yourself unless you buy more tickets over time than you can afford, but you are not likely to win anything either, especially the big prize. Paul R. Thomas, Ed.D., R.D.16
Personal Glimpse
Part Three Nutrition and Fitness200
exists, it usually is better to correct the diet than to take supplements. Several manufacturers have pushed “meals in a can” with nutrition insurance claims like those made for vitamin pills. The major brands are Ensure, Susta- cal, Nutra-Start, Boost, and Resource. The first such product (Ensure) was developed many years ago for use in hospitals and nursing homes for people who were too ill or too weak to eat. However, they have been advertised aggressively to the general public and sold in grocery stores and pharmacies. These products cost between $1 and $2 per 8-ounce can and contain protein, carbohydrates, a modest amount of fat, and significant amounts of a few vitamins and minerals. However, most contain little or no fiber, and all lack carotenoids and other health-protecting plant-based chemicals.19 Canned supplements can benefit ill people who are having dif- ficulty consuming enough calories, but they are a waste of money for people whose appetite is not impaired. Table 11-3 analyzes common sales pitches for “nutri- tion insurance.”
Perspectives on Food Processing To promote the use of supplements, the health-food in- dustry suggests that the processing of food removes its nutritional value. It is true that processing can change the nutrient content of food, but the changes are not drastic. Only a few nutrients are affected by processing, and most losses are insignificant to the overall diet. Food processing and home food preparation can destroy cer- tain vitamins with heat and remove some water-soluble vitamins and minerals through contact with water during cooking. Usually these are only partial losses. Moreover, the nutrients lost from certain foods between the farm and the table are readily obtainable from other foods. For example, although pasteurization of milk destroys some of its vitamin C content, milk is not a significant source of vitamin C anyway. The chief dietary sources of vitamin C are fruits and vegetables. Some nutrient losses in processing (for example, vitamin losses dur- ing the milling of flour) are restored by enrichment. The negative effects of some food-processing operations are more than balanced by the overall positive effects, especially the continuous availability of most types of food items at reasonable cost. As noted in Chapter 10, eating moderate amounts of a wide variety of foods, including some uncooked fruits and vegetables, provides an adequate supply of nutrients.
“Stress Supplements” Many vitamin manufacturers advertise that extra vita- mins are needed to protect against “stress.” While some
companies list only physical stresses that supposedly increase vitamin needs, some include mental stress, overwork, and the like. Some companies market products for the “special needs” of athletes, housewives, busy executives, and smokers. Others make no health claims at all, relying only on the product’s name to sell it. “Stress-formulas” typically contain several times the RDA for vitamin C and several B vitamins. The products manufactured by drug companies do not provide toxic amounts of these ingredients. But some marketed by health-food industry companies contain enough vitamin C to cause diarrhea, and some contain enough B6 to cause nerve damage over a long period. Some formulas contain questionable food substances such as spirulina, bee pollen, and ginseng to make them appear more “complete.” Herbal and homeopathic “stress formulas” are also available. Although vitamin needs may rise slightly in certain physical conditions, they seldom exceed the RDA, and they are easily met by eating a balanced diet. Anyone really in danger of deficiency as a result of illness would be very ill and probably require hospitalization. Some vitamin manufacturers suggest that strenuous physical activity increases the need for vitamins so that people who engage in vigorous exercise or athletics should take supplements. Strenuous exercise does in- crease the need for calories, water, and a few nutrients. However, the nutrient needs are unlikely to exceed the RDAs. Even if above-RDA amounts were necessary, they would be supplied by the increase in food intake normally associated with exercising. The belief that extra vitamins are useful to athletes is also tied to the idea that extra vitamins provide extra energy—which is un- true. Vitamin concoctions pitched to athletes (so-called ergogenic aids) are discussed further in Chapter 13. Smokers tend to have lower blood levels of vitamin C than do nonsmokers. In 2000 the RDA for vitamin C was set at 75 mg for men and 90 mg for women, with an additional 35 mg for smokers. However, no evidence ex- ists that smokers are deficient in vitamin C.20 Regardless of whether smokers need extra vitamin C, all of these amounts are readily obtainable from food. No scientific evidence shows that emotional stress increases one’s need for vitamins. In 1985 E.R. Squibb & Sons, Inc., agreed to pay $15,000 to New York State and to stop making false and misleading claims for its Theragran Stress Formula. In 1986 Lederle Laborato- ries agreed to pay $25,000 and to stop suggesting that Stresstabs could reduce the effects of psychologic stress or the ordinary stress of life. Both cases were prosecuted by New York’s attorney general. In a 1985 interview, Lederle’s chief of nutrition science acknowledged that
Chapter Eleven Nutrition Fads, Fallacies, and Scams 201
aNalysis oF misleadiNg ads that promote “NutritioN iNsuraNce” Table 11-3
Claim Remember that the health of your eyes, teeth, bones, and
internal systems depends upon a sufficient intake of these vital nutrients.a
No matter how hard you try, in our fast food society, it’s often difficult to make sure you’re getting enough es- sential vitamins and minerals in the food you eat.b
You might not always take the time to count nutrients. Isn’t it nice to know we’ve done that for you?c
How much of your vitamin C gets lost on the way to the table? Picking, packing, processing. All these plus transportation can lead to the destruction of part of the vitamin C in your foods.d
It would take a computer and a good deal of conscious effort to devise a diet that each day would give all the nutrients in optimum amounts. Even well-trained nutri- tionists find it difficult to get complete nutrition in their diet.e
Getting a balanced diet can be tough, especially when you’re busy with other things. So to avoid taking chances, take a supplement.d
Most packaged foods have many, if not all, of the natural nutrients removed during processing and replaced with chemicals.f
Our soils are depleted of minerals and therefore cannot grow nutritious foods.
“I take my vitamins every day. Just to be on the safe side.” (Said by man pictured climbing a steep mountain.)d
Most of the water-soluble vitamins—B-complex and C—should be replaced daily. That’s why a good diet is so important. Stresstabs high potency stress formula vitamins can help you to back up your diet because they concentrate on vitamins your body can’t store.g
Theragran-M is “fine-tuned for the way you live.” (Said during a television commercial depicting attractive young people doing various athletic activities.)
Scientists are now studying the nutritional role of vita- mins, minerals and other nutrients in helping to protect against diseases such as cancer, heart disease, and osteoporosis.h
Geritol Extend has all the vitamins the National Academy of Sciences recommends for people over 50.i
Rich in Vitamin B Complex and Biotin, the “energy re- leasers” essential for converting food into energyj
Comment Messages of this type, intended to make one nutrient-con-
scious, are true but misleading. They never say how to tell if one is getting enough.
Falsely suggests that balancing one’s diet is difficult.
Counting nutrients is not necessary. Food-group systems require only the counting of portions.
The real issues are how much remains in one’s diet and whether it is enough. Most Americans consume ad- equate amounts of vitamin C.
Falsely implies that ordinary people are at risk unless they take supplements. Food-group systems such as the USDA Food Guidance System (see Chapter 10) provide for adequate amounts of nutrients and are easy to follow.
Falsely suggests that busy people have difficulty in eating a balanced diet.
Greatly exaggerates the amount of nutrients lost in pro- cessing; exploits public fear that our foods contain too many “chemicals.”
Falsely suggests that adequate nutrition can be obtained only by ingesting food supplements or special foods.
Misleading comparison of dangers of mountain climbing and of not taking daily vitamin pills.
Water-soluble vitamins do not need to be replaced daily. Using vitamins to “back up” a good diet is a waste of money. If a supplement is desired, there is no reason to select a “high-potency” (above-RDA) product.
Except for food intake, lifestyle characteristics have little to do with vitamin or mineral needs. The imag- ery falsely suggests that the product is likely to make people more vigorous.
The fact that various nutrients are being studied does not mean that supplementation with these nutrients has been proven beneficial.
The RDAs are higher than most people need. The Acad- emy does not recommend supplementation for everyone over 50.
Subtly suggests that taking the product will cause users to have more energy, which is untrue.
aVitamin, mineral and food supplement guide (flyer), Safeway, 1979. bAdvertising flyer, Sears, 1979. cAd for Ensure at www.myhealthpro.net, 2005. dMagazine ads, Hoffmann-La Roche, 1981-1983. eThompson RW. Why you should take vitamins and minerals (flyer). General Nutrition Corporation, 1983.
fNeo-Life Corporation. Sharing the new life through better nutrition . . . every day of your life! Counselor, Feb 1979, pp 3–5. gMagazine ad, Lederle Laboratories, 1991-1992. hMagazine ad, Council for Responsible Nutrition, 1989. iMagazine ad, SmithKline Beecham, 1990. jMagazine ad, E.R. Squibb & Sons, 1988.
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“people who eat a balanced diet do not need stress vi- tamins—or for that matter any vitamin supplement at all.”21 In 1990 Miles Laboratories (makers of One-A-Day products) signed a three-year “assurance of discontinu- ance” order with the attorneys general of New York, California, and Texas and agreed to pay $10,000 to each of these three states. Without admitting wrongdoing, the company pledged not to claim that (a) the average consumer needs a supplement to prevent mineral and vitamin loss, (b) vitamins can prevent or reverse lung damage caused by pollution, (c) routine daily stress de- pletes vitamins, and (d) routine physical exercise (such as the aerobics shown in Miles’ television ad) depletes essential minerals. In 1994 Dr. Stephen Barrett22 petitioned the FDA to (a) remove vitamins and other ineffective ingredients from products marketed for the prevention or relief of “stress” and (b) to issue a public warning that although the FDA has permitted “stress formulas” to be sold, it does not recognize them as effective against emotional stress or ordinary stress. In 1996 the petition was denied. The agency’s denial letter to Dr. Barrett indicated that the FDA regarded the claims as statements of “nutritional support” and that the mandatory DSHEA disclaimer (see page 198) was “sufficient to inform consumers that FDA has not evaluated a claim made for a dietary supplement.”
“Natural” vs Synthetic Vitamins Many promoters claim that “natural” vitamins are better than the synthetic vitamins. Such claims are unfounded. A few synthetic vitamins have slightly different struc- tures than their natural counterparts, but these differences are of no importance inside the body. As noted by Her- bert,23 vitamins are specific molecules; the body makes no distinction between vitamins made in the “factories” of nature and those made in the factories of chemical companies. The prices of “natural” vitamins tend to be higher than those of synthetic vitamins.
Antioxidants and Other Phytochemicals Many “antioxidant” products are marketed with claims that, by blocking the action of free radicals, they can help prevent heart disease, cancer, and various other conditions associated with aging. Figure 11-1 shows an ad with this type of message. Free radicals are atoms or groups of atoms that have at least one unpaired electron, which makes them highly reactive. Free radicals promote beneficial oxidation that produces energy and kills bacterial invaders. In excess,
however, they produce harmful oxidation that can dam- age cell membranes and cell contents. It is known that people who eat adequate amounts of fruits and vegetables high in antioxidants have a lower incidence of cardiovas- cular disease, certain cancers, and cataracts. Fruits and vegetables are rich in antioxidants, but it is not known which dietary factors are responsible for the beneficial effects. Each plant contains hundreds of phytochemicals (plant chemicals) whose presence is dictated by heredi- tary factors. Only well-designed long-term research can determine whether any of these chemicals, taken in a pill, would be useful for preventing any disease. The most publicized nutrients with antioxidant properties are vitamin C, vitamin E, and beta-carotene (which the body converts into vitamin A). Many large clinical trials have tested their effectiveness.24 In 2007, a Cochrane Collaboration team25 concluded that com- monly taken antioxidant supplements may do more harm
Figure 11-1. Ad that appeared in many health-food industry publications during 1994. Small print at the bottom cited a report in Medical Tribune (a newspaper for doctors) as the source of the “8 out of 10” statistic. No survey on antioxidant usage had actually been done; the editor had merely asked for opinions on the use of vitamin E. About 80% who responded wrote favorable comments, many of which described their recommendations to patients. No attempt was made to determine whether the respondents were typical of Medical Tribune readers or physicians in general, or whether they personally took supplements. The percentage of people who do or don’t do something cannot be measured this way.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 203
than good. Their review encompassed 68 randomized controlled trials with 232,606 participants who took vari- ous combinations of beta-carotene, vitamin A, vitamin C, vitamin E, and/or selenium or a placebo or had no intervention. The reviewers concluded:
• There was no convincing evidence that antioxidant supple- ments have beneficial effects on overall death rate.
• In 47 trials with 180,938 participants, the antioxidant supplements significantly increased the death rate.
• Beta-carotene, vitamin A, and vitamin E given singly or combined with other antioxidant supplements significantly increase mortality.
• The potential roles of vitamin C and selenium on mortality need further study.
• Considering that 10% to 20% of the adult population in North America and Europe may consume the assessed supplements, the public health consequences may be sub- stantial.
• Because the study examined only the influence of synthetic antioxidants, its findings should not be applied to the po- tential effects of eating fruits and vegetables.
Charles Hennekens, M.D.,26 who participated in two of the large studies, has pointed out that even if antioxidants could provide the benefits suggested by epidemiologic studies, smoking cessation and other lifestyle factors would have a far greater effect on the rates of lung cancer and coronary heart disease. The Medical Letter27 has concluded that (a) there is no convincing evidence that taking supplements of vitamin C prevents any disease and (b) no one should take high-dose beta-carotene supplements. Research is also being done to determine whether taking supplements or eating foods rich in antioxidants can protect against age-related macular degeneration (AMD), a disease in which the central portion of the retina deteriorates so that only peripheral vision remains. So far, the results have been conflicting. Referring to the most promising study, The Medical Letter28 has cau- tioned that (a) the magnitude of the reported benefit was modest, (b) no data suggest any benefit for people who do not have AMD or who have only mild disease, and (c) the increased death rate from lung cancer in smok- ers who took beta-carotene in other studies is evidence enough that high doses of vitamins and minerals are not necessarily harmless. The negative publicity has not deterred manufactur- ers from continuing to market antioxidants as though they have been proven beneficial. Some have responded by hyping new mixtures of beta-carotene and other ca- rotenoids, which, they suggest, may provide the same benefits as fruits and vegetables.
Many types of pills described as “concentrates” of fruits and/or vegetables are being marketed. However, it is not possible to condense large amounts of produce into a pill without losing fiber, nutrients, and many other phytochemicals.29 Although some products contain sig- nificant amounts of nutrients, these nutrients are readily obtainable at lower cost from foods. In 2002, Pharmanex began promoting its BioPho- tonic Scanner for measuring “the antioxidant level in the body” when a person’s hand is placed in front of the device. The test is said to measure the carotenoid level, but virtually everyone who takes the test is advised to buy expensive supplements. Barrett24 warns that neither the scan nor the products have been proven to lead to improved health outcomes.
Amino-Acid Products Many supplement products containing amino acids are marketed as weight-loss and/or ergogenic aids de- spite lack of evidence that they are effective for either purpose (see Chapters 12 and 13). The Federation of American Societies for Experimental Biology (FASEB) has sharply criticized this situation. After extensive review of the scientific literature, FASEB experts concluded: (a) single- or multiple-ingredient capsules, tablets, and liquid products are used primarily for phar- macologic purposes or enhancement of physiologic functions rather than for nutritional purposes; (b) little scientific literature exists on most amino acids ingested for these purposes; (c) no scientific rationale has been presented to justify ingestion of amino-acid supplements by healthy individuals; (d) safety levels for amino-acid supplement use have not been established; and (e) a systematic approach to safety testing is needed.30
megaVitamiN claims Vs Facts
Claims are widespread that high dosages of vitamins and minerals can prevent or cure a great diversity of ailments. Dr. Linus Pauling, a Nobel Prize winner in chemistry and former professor of chemistry at Stanford University, was the chief theoretician for this approach, which he termed “orthomolecular” treatment (ortho is Greek for “right”). This approach supposedly provides the correct amounts of nutritionally “right” molecules normally found in the body. It began during the early 1950s as megavitamin therapy for schizophrenia and is also called “nutritional medicine.” This section examines some megavitamin claims, the evidence against them, and the dangers involved. Megavitamin treatment for emotional problems is discussed in Chapter 6.
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Pauling and Vitamin C Controversy over the use of massive dosages of vitamin C stems largely from Pauling’s publications. His 1970 book, Vitamin C and the Common Cold, claimed that taking 1000 mg of vitamin C daily would reduce the incidence of colds by 45% for most people, but that some needed much larger amounts. The book’s 1976 revision, Vitamin C, the Common Cold and the Flu, suggested even higher dosages. A third book, published in 1979, claimed that high dosages of vitamin C may be effective against cancer.31 A flyer distributed in 1991 by the Linus Pauling Institute recommended daily doses of 6000 to 18,000 mg of vitamin C, 400 to 1600 IU of vitamin E, and 25,000 IU of vitamin A, plus various other vitamins and minerals. Pauling himself reportedly took 12,000 mg of vitamin C daily and raised the amount to 40,000 mg if symptoms of a cold appeared. However, most medical and nutritional scientists strongly disagree with Pauling’s views concerning vitamin C. Experiments on the possible value of vitamin C for preventing infections have been conducted by medical investigators ever since the vitamin became commercial- ly available during the 1930s. At least 15 well-designed double-blind studies have shown that supplementation with vitamin C does not prevent colds, and that, at best, it may slightly reduce the symptoms of a cold.32 Slight symptom reduction may occur because of an antihistamine-like effect, but whether this has practical value is debatable. Pauling’s views were based on the same studies that other scientists have analyzed, but his conclusions differed. The largest clinical trials, involving thousands of volunteers, were directed by Dr. Terence Anderson, professor of epidemiology at the University of Toronto. Taken together, his studies suggest that extra vitamin C intake may slightly reduce the severity of colds, but it is not necessary to take the high doses recommended by Pauling to achieve this result. Nor is there anything to be gained by taking vitamin C supplements year-round in the hope of preventing colds.33 Another important study was reported in 1975 by scientists at the National Institutes of Health who had compared the effects of vitamin C pills with a placebo before and during colds. Although the experiment was designed to be double-blind, half the subjects guessed which pill they were getting. When the results were tabu- lated, the average number of colds reported per person was 1.27 for the vitamin group and 1.36 for the placebo group over a 9-month period. But among the half who had not guessed which pill they had been taking, no difference in the incidence or severity was found. This
illustrates how people who think they are doing some- thing effective (such as taking a vitamin) can report a favorable result even when none exists.32
In 1976 Pauling and Ewan Cameron, a Scottish phy- sician, reported that most of 100 patients with terminal cancer treated with 10,000 mg of vitamin C daily had survived three to four times longer than similar patients who did not receive vitamin C supplements. However, Dr. William DeWys, chief of clinical investigations at the National Cancer Institute, found that the study was poorly designed because the patient groups were not comparable. The vitamin C patients were Cameron’s, whereas the other patients were under the care of other physicians. Cameron’s patients started taking vitamin C when he labeled them untreatable by other methods, and their subsequent survival was compared with the survival of the “control” patients after they had been labeled un- treatable by their doctors. DeWys34 reasoned that if the two groups were comparable, the lengths of time from entry into the hospital to being labeled untreatable should be similar in both groups. However, Cameron’s patients were labeled untreatable much earlier in the course of their disease—which means that they entered the hospital before they were as sick as the other doctors’ patients and would naturally be expected to live longer. In 1979 the Mayo Clinic reported a double-blind study of 123 patients with advanced cancer. Half of the patients received 10,000 mg of vitamin C daily, while the others were given a placebo. No differences were found between the two groups in survival time, appe- tite, weight loss, severity of pain, or amount of nausea and vomiting.35 Other well-designed studies reported in 1983 and 1985 yielded similar results.36,37 Pauling died of prostate cancer in 1995.
Therapeutic Claims for Megavitamin E Claims have been made that large dosages of vitamin E are effective treatment for acne, atherosclerosis, cancer, diabetes, sexual frigidity, infertility, repeated spontane- ous abortions, muscular dystrophy, peptic ulcers, rheu- matic fever, and fibrocystic disease of the breast. Some proponents have claimed that vitamin E will increase stamina, prolong life, and protect against the effects of atmospheric pollution. Vitamin E is added to aftershave lotions, soaps, and underarm deodorants. However, it has no proven therapeutic, nutritional, or cosmetic value for any of the these.32
Vitamin E deficiency symptoms in humans that are traceable only to an inadequate diet have never been re- ported, except in premature infants. In adults, deficiency has been observed only in patients with an inability to
Chapter Eleven Nutrition Fads, Fallacies, and Scams 205
absorb fat during the digestive process (vitamin E is fat-soluble). More than 40 years ago several researchers placed human volunteers on a low-vitamin E diet for 41/2 years to see whether this would produce signs of deficiency. The volunteers had minor changes in their red blood cells but experienced no symptoms.32 Thus it is clearly irrational for healthy persons to take vitamin E supplements as protection against deficiency. Vitamin E may ultimately be shown to have a limited role in preventing and treating coronary heart disease, but the evidence so far indicates that vitamin E supplements are not helpful and may be harmful.
Dangers of Excess Vitamins and Minerals Vitamins in excess of the body’s needs seldom serve a useful function and can be harmful. Excess amounts of fat-soluble vitamins are stored in body fat, where they can build up to toxic levels over time. Excess water- soluble vitamins are excreted through the urine, but these can still have adverse effects. Vitamin A toxicity can result from ingesting too much vitamin A on a regular basis for months or years. The problems that develop as body stores build up in- clude headache, hair loss, bone malformation, bleeding tendencies, bone fracture, muscle and joint pain, vi- sion problems, retarded growth in children, drying and cracking of the skin, and enlargement of the liver and spleen. Most adverse effects disappear after excessive intake is stopped, but permanent damage can occur to the liver, bones, and eyes. Liver damage in adults has been reported at daily doses of 25,000 IU or more.38 Vitamin A supplements taken early in pregnancy are hazardous to the developing fetus. A study published in 1995 concluded that among the babies born to women who took more than 10,000 IU per day in the form of supplements, about 1 in 57 had a birth defect attributable to the supplements.39
Prolonged excessive intake of vitamin D (usually five times the RDA or more) can cause loss of appetite, nausea, weakness, weight loss, excess urinary output, constipation, vague aches, stiffness, kidney stones, tissue calcification, high blood pressure, acidosis, and kidney failure (which can lead to death). The Personal Glimpse box describes how a supplement promoter and a customer ingested too much vitamin D from an ap- parently defective product. Niacin doses in the range of 40 to 300 times the RDA can cause severe flushing, itching, liver damage, skin disorders, gout, ulcers, and blood-sugar disorders. (Despite this, large doses administered under medical supervision can be valuable for controlling abnormal blood cholesterol levels, as described in Chapter 15.)
Excessive vitamin E (usually 400 IU or more) can cause headaches, nausea, tiredness, giddiness, inflam- mation of the mouth, chapped lips, gastrointestinal disturbances, muscle weakness, low blood-sugar levels, and increased bleeding tendency. Vitamin C, in amounts upwards of 20 times the RDA, can damage growing bone, produce diarrhea, cause adverse effects in pregnancy, and cause false urine tests for glucose in diabetics. Large doses can also produce false-negative tests for blood in the stool and thereby prevent early detection of serious gastrointestinal diseases, including cancer. Very large doses of B6 (2000 mg or more; 1000 times the RDA) have caused symptoms resembling those of multiple sclerosis, including numbness and tingling of the hands, difficulty in walking, and the feeling of electric shocks shooting down the spine. Although most of the afflicted individuals recovered after they stopped taking B6 supplements, some did not. In the 1980s it was discovered that more than 100 women attending a
Personal Glimpse
Vitamin D Poisoning
Gary Null, Ph.D., whose books bill him as “one of America’s leading health and fitness advocates,” promotes dubious treatments for many serious diseases. He hosts radio and television talk shows, writes books, gives lectures, and markets supplement products. He opposes fluoridation, immunization, food irradiation, amalgam fillings, and many forms of proven medical treatment. Null obtained a Ph.D. degree from an accred- ited school. However, Barrett40 has pointed out that (a) his Ph.D. committee members lacked expertise in the subject matter of his thesis; (b) portions of the thesis appear to have been derived from previous writings that had multiple authors; and (c) the conclusions in the thesis were based on the results of urine tests that have no scientific validity. In 2010, a man who developed nausea, vomiting, mood swings, headaches, severe cramping, pain, and fatigue after using Gary Null’s Ultimate Power Meal filed suit against Null, his company, and the suppliers of the product. The complaint stated that the product was produced with 1000 times as much vitamin D as it should have and Null failed to warn consumers when he discovered this. Null also sued his own supplier, alleging that (a) he nearly died as a result of using the product himself and (b) he and his company had suf- fered great harm to their reputation. Two weeks later, however, he filed an amended complaint that omitted the claims related to his own alleged illness.
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clinic specializing in treating premenstrual syndrome had developed neurologic symptoms as a result of taking vitamin B6. Ninety-two had taken less than 200 mg (100 times the RDA) daily for more than 6 months. Twenty of them had taken less than 50 mg per day.41 The lowest dosage on which anyone developed symptoms was 20 mg per day for 2 years; the shortest time was 2 months of 100 mg per day. All of their symptoms resolved when the B6 was stopped. As with fat-soluble vitamins, excess amounts of most minerals are stored in the body and can gradually build up to toxic levels. An excess of one mineral can also interfere with the functioning of others. Certain people can benefit from mineral supplements, but they should never be used without medical supervision.
Barrett and Herbert7 state that there are only two situations in which vitamin use at higher-than-RDA levels is legitimate: (1) treatment of medically diagnosed deficiency states—conditions rare except among alcohol- ics; persons with intestinal absorption defects; and the poor, especially those who are pregnant or elderly and (2) certain problems for which large doses of vitamins (e.g. niacin) are used as drugs—with full recognition of any risks involved.
appropriate use oF supplemeNts
In general, supplements are useful for individuals who are unable or unwilling to consume an adequate diet. Physicians commonly recommend vitamins for very young children until they are eating solid foods that contain enough vitamins. After a child reaches the age of 2, however, it is seldom necessary to continue supple- ments “just to be sure.” Three exceptions are noteworthy:
• Fluoride supplements should be given to children not drink- ing fluoridated water. (See Chapter 7 for dosage.)
• Children with poor eating habits and those using weight- reduction diets can be given a multivitamin-mineral supple- ment containing nutrients not exceeding RDA levels.
• Children on strict vegetarian diets may need supplementa- tion, particularly of vitamin B12.
The U.S. Preventive Services Task Force42 recom- mends that women who might become pregnant take a daily multivitamin or multivitamin-mineral supplement that contains 0.4 to 0.8 mg of folic acid in order to reduce the risk of birth defects in their offspring (see Chapter 10). Although a well-balanced diet will provide adequate amounts of folic acid, the Task Force believes that, for some women, achieving adequate dietary intake might be more difficult than taking supplements.
People using prolonged weight-reduction diets, par- ticularly diets that are less than 1200 calories per day or are nutritionally unbalanced, may benefit from a multivi- tamin-mineral supplement. Individuals recovering from surgery or serious illnesses that have disrupted normal eating habits may also benefit from supplementation. Elderly persons who become sedentary or lose inter- est in eating may not get sufficient nutrients; they, too, may benefit from multivitamin-mineral supplementation. Unadvertised brands costing about 5 cents per day are available. Because iron deficiency is not rare, a National Academy of Sciences committee has recommended that pregnant women take a 30-mg supplement daily during the second and third trimesters. Although adequately nourished women do not need supplementation, it is simpler and less costly to supplement the diet than to measure blood iron levels several times during the preg- nancy. The committee also suggested that although the best way to obtain nutrients is from food, pregnant women who ordinarily do not consume an adequate diet might benefit from a multivitamin-mineral supplement con- taining moderate dosages of iron, zinc, copper, calcium, vitamin B6, folic acid, vitamin C, and vitamin D.43 Women should be sure that their intake of calcium is adequate to help prevent thinning of their bones (osteo- porosis). This can be done with adequate intake of dairy products, but some women prefer calcium supplements. Women should discuss this matter with their physician or a registered dietitian. Chapter 19 discusses this further.
“orgaNic” Foods
Promoters of “organic” foods often suggest that these are safer and more nutritious than conventionally grown foods. In scientific usage, “organic” refers to compounds that contain carbon, which all food substances do. How- ever, in 1972, Robert Rodale, editor of Organic Garden- ing and Farming magazine, presented this “consensus definition” at a hearing conducted by New York State Attorney General Louis Lefkowitz:
Food grown without pesticides; grown without artificial fer- tilizers; grown in soil whose humus content is increased by the additions of organic matter, grown in soil whose mineral content is increased by the application of natural mineral fertilizers; has not been treated with preservatives, hormones, antibiotics, etc.44
Many scientists believe this definition is inherently misleading because:
Chapter Eleven Nutrition Fads, Fallacies, and Scams 207
• Surveys have found that organically grown foods are less likely than conventional foods to contain pesticides. How- ever, the amounts involved are tiny and pose no known health risk.45 Pesticides on the outside of fruits and veg- etables may be removed or significantly reduced by wash- ing. To protect consumers, the FDA sets tolerance levels in foods and conducts frequent “market basket” studies wherein foods from regions throughout the United States are purchased and analyzed. The most recent study found that about 70% of 5053 fruits, vegetables, and other domes- tic or imported foods had no detectable pesticide residues. Violative levels were found in only 0.9% of the domestic foods and 4.7% of the imported ones.46 The agency’s annual Total Diet Study found that dietary intakes of pesticides for all population groups were well within international and Environmental Protection Agency standards.
• Plants obtain nutrients from soil in their inorganic state. Organic fertilizers must decompose before their nutrients become available for absorption. What counts is the avail- ability of required nutrients rather than the type of fertilizer.
• Plant nutrient content is determined primarily by heredity. Mineral levels may be affected by the mineral content of the soil, but this has no significance in the overall diet. If essential nutrients are missing from the soil, the plant will not grow. If plants grow, that means the essential nutrients are present. As Deutsch47 noted long ago, this is logical because a plant does not make its nutrients “as a generous gesture to humans but for its own growth and survival.” Experiments have found no significant differences in the nutrient content of organically grown crops and those grown under standard agricultural conditions.48
• The taste of raw food is determined by the product’s genetic programming, ripeness when harvested, and freshness. Studies have found no significant difference in taste quality between “organic” and conventionally grown samples.49
“Organic” agriculture is sometimes referred to as “alternative” or “sustainable” agriculture. Neither of these terms is precisely definable.50 Critics also note that “organic” agriculture yields less food per acre and thus requires more land than conventional agriculture. Foods labeled organic nearly always cost more than their conventional counterparts. Since they can- not be told apart by their appearance, some producers and retailers have labeled conventionally grown foods “organic” to increase profits. In 1990, in response to persistent pressure by proponents, Congress passed the U.S. Organic Foods Production Act, which directed the U.S. Secretary of Agriculture to establish certification standards. Commenting on the bill, Larkin51 stated:
“Organic certification” isn’t the answer. It will merely create more confusion and distrust in the marketplace. Foods certi- fied as “organic” will neither be safer nor more nutritious than “regular” foods. They will just cost more. Instead of spending
money to legitimize nutrition nonsense, our government should do more to attack its spread.
Nevertheless, the required standards were estab- lished in 2002, and people who sell or label a product as “organic” when they know it does not meet USDA standards can be fined up to $10,000 per violation. Figure 11-2 shows the organic certification seal.
“health” aNd “Natural” Foods
The terms health food, natural food, and organic food are often used interchangeably by both sellers and con- sumers. Vegetarian foods and foods labeled “dietetic” may also be referred to as health foods. “Health foods” are claimed to be special foods that can benefit people’s health. Nutrition authorities believe that this term is inherently misleading, because all foods are healthy when eaten in moderation and can be un- healthy when eaten in excess amounts. Stare, Aronson, and Barrett53 have observed:
It’s Your Decision
The Official “Organic” Definition In October 2002, the U.S. Department of Agriculture52 issued the following definition of “organic food” ac- companied by a cautionary note:
Organic food is produced by farmers who emphasize the use of renewable resources and the conservation of soil and water to enhance environmental quality for future generations. Organic meat, poultry, eggs, and dairy products come from animals that are given no antibiotics or growth hormones. Organic food is produced without using most conventional pesticides; fertilizers made with synthetic ingredi- ents or sewage sludge; bioengineering; or ionizing radiation. Before a product can be labeled “organic,” a Government-approved certifier inspects the farm where the food is grown to make sure the farmer is following all the rules necessary to meet USDA organic standards. Companies that handle or process organic food before it gets to your local supermarket or restaurant must be certified, too. . . .
USDA makes no claims that organically produced food is safer or more nutritious than conventionally produced food. Organic food differs from con- ventionally produced food in the way it is grown, handled, and processed.
Do you think that enforcement of “organic” labeling standards will benefit consumers?
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The term is merely a gimmick used to boost sales. . . . Some foods popular as “health foods” are rich in nutrients, but no food has unique health-promoting properties. All foods can contribute to health when eaten as part of a varied and balanced diet. The problem with so-called health foods is that they are promoted with false claims and usually are overpriced.
The foods eaten are not useful in the body until they are broken down into their component nutrients before being absorbed from the digestive tract; thus claims that certain foods are especially healthful should be evaluated by considering the components of these foods. Con- fronted with such claims, intelligent consumers should ask the following:
• What are the food’s significant components and their nu- tritional value?
• Can special health claims made about it be scientifically justified?
• What other foods are comparable? • How do comparable foods compare in price?
Table 11-4 lists commonly promoted “health foods,” supplements, hormones, and other products sold in health-food stores. “Natural” foods are said to be those produced with minimal processing and without additives, artificial ingredients, irradiation, or genetic modification. The word “natural,” like the word “organic,” usually means that the product is higher-priced. Advocates of “natural foods” say that processing reduces nutritional value and that additives are harmful. Critics of the designation “natural” maintain that the American food supply is the safest and best the world has ever seen. They also state that “natural” cannot be meaningfully defined because there is no sharp dividing line between processed and unprocessed foods. Irradiated and genetically engineered foods are discussed in Chapter 25. Purposes and Safety of Food Additives A few basic facts about additive processing should reas- sure consumers. About 3000 substances are intentionally added to foods54 for one or more of the following reasons:
• Maintain or improve nutritional value: Vitamins and miner- als may be added to enrich (replace those lost in processing) or fortify (add nutrients that may be lacking in the diet). In enriched bread, for example, iron, thiamin, and niacin are restored to the levels found in whole wheat, and riboflavin is added to a higher level.
• Maintain product safety and freshness: Preservatives are used to prevent food spoilage due to bacteria, molds, and yeast; extend shelf life; protect food against undesirable changes in color and flavor; and protect food fats from becoming rancid.
• Aid in preparation: Emulsifiers, stabilizers, thickeners, texturizers, and anti-caking agents improve the homogene- ity, consistency, stability, texture, and “mouthfeel” of food; leavening agents affect baking results; pH control agents affect acidity and alkalinity; humectants cause moisture retention; maturing and bleaching agents and dough con- ditioners improve the quality of baked goods.
• Improve taste or appearance: Flavor enhancers, flavors, and sweeteners may alter the original taste and/or aroma or restore flavor lost in processing; colors may make foods more appealing.
The most widely used additives are sugar, salt, and corn syrup—all found naturally. These three, plus citric acid (found naturally in oranges and lemons), baking soda, vegetable colors, mustard, and pepper, account for 98% of all food additives by weight used in the United States. To promote “natural” foods, the health-food in- dustry alleges that too many chemicals are added to our foods. The important issue, however, is not the number of chemicals, but whether they are safe and serve use- ful purposes. It is illogical to condemn additives with sweeping generalizations; the only proper way to evalu- ate them is individually. This is the responsibility of the FDA, which has paid a great deal of attention to this matter. Food additives have survived stringent evaluation procedures not applied to the great majority of natural products. To remain in use, additives must be judged not only safe but also functionally important. During the early 1980s, a USDA committee ranked food additives eighth on a list of ten areas of food safety that deserved further research.55 Since that time, no such “official” ranking has been repeated, but profes- sional publications continue to reflect far more concern about microbial toxins and infections than about food additives. Since September 11, 2001, there has also been much concern about possible terrorist attacks, by chemical or microbial means, aimed at the food supply.
—Text continued on page 213.
Figure 11-2. The organic certification seal can be displayed on the labels of foods said to contain “at least 95% organic ingredients.” Its use is voluntary.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 209
products commoNly sold iN health-Food stores
Table 11-4
The following are commonly promoted “health foods,” supple- ments, and other products sold in health-food stores. Those marked with an asterisk (*) have been reported as hazardous. Popular herbs are discussed in Table 11-5, page 214.
Acidophilus: Lactobacillus acidophilus is a bacterial or- ganism that ferments the sugars present in milk. Capsules of acidophilus are claimed to aid digestion and promote the health of the digestive tract. This is impractical, however, because oral doses of the bacteria may not survive the acidic environment of the stomach and the number and activity of the bacteria may be reduced during storage. A recent study found that none of 20 “probiotic” products contained the Lactobacillus species listed on their label.56 Acidophilus preparations such as sweet acidophilus milk can be useful to persons who have difficulty digesting lactose (a condition called lactose intolerance). These widely available dairy products are produced by adding acid- tolerant strains of acidophilus bacteria to milk. Those surviving passage into the intestine will produce lactase, an enzyme that helps to digest the milk’s lactose. However, individuals with lactose intolerance should have guidance from a physician, and use of lactase without the bacteria may be an alternative. Lactase-treated milk is available in supermarkets throughout the United States.
Activated charcoal: Supplements labeled “activated or- ganic charcoal” are usually said to be made by burning “natural organic” peat moss. Charcoal supposedly absorbs intestinal gases and “serves as a powerful detoxicant” that combats “gas” and “makes you feel intestinally clean.” However, this product is of little value and can add to gastrointestinal distress by interfering with the action of digestive enzymes.
*Alfalfa: Although its advocates suggest that alfalfa con- tains certain nutrients that more common plant foods do not, it actually has less nutritional value than most of the more popular vegetables such as broccoli, carrots, and spinach. Alfalfa has also been claimed to contain all of the essential amino acids, but this is untrue. Alfalfa contains l-canavanine, a toxic amino acid that can bring out latent immune disorders, particularly hemolytic anemia, lupus erythematosus, and rheumatoid arthritis.
*Aloe vera: Unsubstantiated claims are made that aloe vera products can cure or alleviate colitis, bursitis, asthma, glaucoma, hemorrhoids, boils, arthritis, intestinal problems, acne, poison ivy, anemia, tuberculosis, cancer, diabetes, de- pression, multiple sclerosis, stretch marks, varicose veins, and even blindness. Aloe skin creams or gels are probably harm- less; and even though it will not reverse the aging process, topical aloe may exert some skin softening and moisturizing effects. However, aloe juice is a harsh laxative that can cause gastrointestinal upset.57
*Bee pollen: Bee pollen is flower pollen harvested from bees. Although claimed to be a “perfect food,” it contains no nutrients that are not present in conventional foods and costs much more than ordinary foods containing the same nutrients. It is also touted as an aid to athletic performance, although
actual tests on swimmers and runners have shown no benefit.58 In susceptible individuals, bee pollen can cause anaphylactic shock, a life-threatening allergic reaction in which swelling of the throat can cause suffocation.59
Bioflavonoids: Bioflavonoids are promoted as essential for good health. They are claimed to increase resistance to colds and the flu. Scientific tests have shown this claim to be false.32 Bioflavonoids are sometimes referred to as “vitamin P,” but they are neither vitamins nor essential for humans.
Blackstrap molasses: Blackstrap molasses is the dark, less- refined form of molasses. It is less sweet than other syrups and has an unpleasant taste. It is touted as a “wonder food” that can restore hair color and cure anemia. Blackstrap molasses is simply another form of sugar. It cannot reverse the graying of hair. It contains variable amounts of iron; consuming a few tablespoons of molasses at regular intervals can contribute significantly to iron intake. However, iron supplementation should not be done without competent medical advice.
*Bone meal: Powdered bone is claimed to be a rich source of calcium. Actually, its calcium is poorly absorbed. FDA scientists have found that some animal bone meal samples contain high levels of lead, a toxic mineral, as a result of lifelong accumulation in old animals.60
Boron: The mineral boron is falsely claimed to be a “su- pernutrient.” It has been said to “end bone disease,” increase muscle mass and strength, suppress menopausal hot flashes, increase sexual desire, correct and prevent arthritis, stop memory loss, and prevent or cure osteoporosis. However, there is no reliable evidence that boron supplements can do any of these things.61 Adequate amounts of boron are readily available from food.
Brewer’s yeast: Brewer’s yeast is used to ferment carbo- hydrate in making beer. It is a source of protein and several B vitamins, but it is certainly no miracle food. Most people dislike its taste.
Carob: Carob beans have been cultivated in Mediterranean countries since ancient times. Carob is used in dog biscuits, as a flavoring agent in chewing tobacco, and as a chocolate substitute in confectionery and snack foods. It is lower in fat than chocolate and is caffeine-free, but it is similar in caloric content and does not taste like real chocolate. Claims of won- drous health benefits associated with carob intake are false.
“Catalyst-altered water”: This water—also known as “Willard’s Water”—is claimed to have been altered by add- ing special submicroscopic particles of silicone, which form a network of molecules that makes the water more “bioactive.” There is no reason to believe that it has any healing properties or is significantly different from normal drinking water.
*Chelated minerals: Chelate means “to bind.” Miner- als in chelated supplements usually are bound to an amino acid, which may increase the efficiency with which they are absorbed from the intestines and excreted through the kidneys. When chelation increases absorption, it equally
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unwanted hair growth, liver enlargement, and other adverse effects that make its use impractical. During the mid-1980s several “DHEA” products marketed through health-food stores were found to contain little or no DHEA. In 1985 the FDA ordered manufacturers to stop marketing DHEA products as weight-loss aids.
Desiccated liver: Desiccated liver in pill or powder form contains a number of nutrients. However, it has no advantage over cooked liver and is more expensive.
*Desiccated thyroid: Dried thyroid gland from a pig or cow is available as a prescription drug for treating hypothyroid- ism (low thyroid function), but responsible physicians rarely prescribe it because its hormonal content can vary from batch to batch; synthetic hormone pills are more reliable.64 Desic- cated thyroid is also an ingredient in some products sold in health-food stores. Dietary supplements containing glandular substances are supposed to be processed so that they contain no active hormone. However, cases have been reported of individuals who ingested toxic amounts of thyroid hormone while self-medicating with such products.
*Dolomite: Dolomite, mined from rocks, contains calcium and magnesium, but in a poorly absorbable form. Lead, arsenic, mercury, and other contaminants have been found in dolomite samples in amounts high enough to cause nerve damage and other health problems.
Enzymes (oral): Many products containing enzymes are claimed to enhance body processes. Enzymes are proteins that act as catalysts in the body. Those present in food are treated in the digestive tract in the same way as any other protein: acid in the stomach and other digestive chemicals reduce them to smaller constituents that are no longer enzymes by the time they are absorbed into the body. The tiny amounts of amino acids that oral enzymes provide make no significant nutritional contribution. Pancreatic enzymes have some legitimate medi- cal uses in diseases that cause decreased secretion of pancreatic enzymes into the intestine, but these conditions are not ap- propriate for self-diagnosis or self-treatment.65
Evening primrose oil: Evening primrose oil, which contains gamma-linolenic acid, may be effective against pre- menstrual discomfort and a few other problems. However, it has not been proven safe for long-term use and is not legally marketable with health claims in the United States. Some products have been adulterated with cheaper oils or were biologically useless due to decomposition.66
Fertile eggs: These eggs supposedly have been fertilized by a rooster, while the supermarket varieties have not. Fertil- ized eggs tend to spoil faster and cost more. Faddists claim that fertilized eggs come from hens that are happier, better adjusted, and more “alive.” Nutritionally, however, they are equivalent. Some faddists claim that brown eggs are nutrition- ally superior to white eggs. However, egg color is hereditary and has nothing to do with nutrient composition.
Fish-oil capsules: Scientific studies have demonstrated that consuming omega-3 fatty acids in fish or supplements can decrease the progression of atherosclerosis and reduce the risk of heart attacks and strokes among people with proven
increases excretion, so there is no net gain. Individuals with a medically diagnosed need for mineral supplements should not take chelated forms, which are more expensive and may not be as effective.
Chitosan: Chitosan is derived from chitin, a polysaccharide found in the exoskeleton of shellfish such as shrimp, lobster, and crabs. It is claimed to cause weight loss by binding fats in the intestinal tract and preventing them from being digested and absorbed. Although chitosan may decrease fat absorption, the amount in the products is too small to significantly affect cholesterol levels. There is no evidence that chitosan is effec- tive for weight control.62
Chlorophyll: Chlorophyll, the pigment responsible for the green color of plants, helps “trap” the energy from sunlight, enabling the plant to synthesize carbohydrates. Claims that chlorophyll is effective against many diseases and can reduce odors are not substantiated. It can kill certain bacteria but is too weak to have practical use as an antibiotic or a toothpaste additive. Chlorophyll is sometimes said to function as the “blood” of plants, but it does not.
Choline: Choline occurs in many foods, so that supple- mentation should not be necessary. It has a few medical uses, but there is no reason to believe that it will improve memory or “counter the aging process” as claimed by faddists.
Chromium picolinate: Chromium picolinate is a chro- mium-containing supplement patented by Gary W. Evans, Ph.D., and claimed to help shed fat and increase muscle mass. Independent research does not support these claims. (Patenting laws do not require proof that claims made for health products are valid.)
Cider vinegar: Vinegar made from apples has long been touted as a cure-all, often together with honey. Cider vinegar is claimed to “keep the body in balance,” thin the blood, and aid digestion—none of which is true. Like the supermarket variety, cider vinegar is a condiment (flavoring agent), but the myths surrounding its use should be ignored.
*Colloidal silver: Colloidal silver is a suspension of sub- microscopic metallic silver particles in a colloidal base. It is falsely claimed to be effective against more than 650 bacterial and viral disease agents. Long-term use of silver preparations can lead to argyria, a condition in which silver salts deposit in the skin, eyes, and internal organs, and the skin turns gray. Although few cases due to colloidal silver have been reported, its use is senseless because it offers no proven benefit.63
Cold-pressed oils: Most vegetable oils are filtered to remove impurities and have antioxidant preservatives added to prevent rapid spoilage. “Cold-pressed” oils are processed differently but offer no health advantage over oils processed by the usual methods.
Dehydroepiandrosterone (DHEA): “DHEA pills” have been promoted with false claims that they have anti-aging properties and can cause effortless weight loss. In experiments with certain strains of mice, DHEA has blocked tumors and prevented weight gain. Scientists have speculated that de- clining levels of this adrenal hormone after young adulthood play a role in aging. However, significant dosages can cause
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coronary artery disease. Additional studies are needed to evaluate whether apparently healthy people will also benefit. Because fish oil supplements can have adverse effects, a physician should be consulted about the advisability of using them.67 (See Chapter 15 for more information.)
*Germanium: “Organic germanium” is touted as a “mir- acle drug” for a wide range of health problems. Proponents claim that cancer, heart disease, mental deficiency, and many other problems are due to an “oxygen deficiency” that organic germanium can eradicate. There is no scientific evidence to support these claims. A few germanium compounds have been tested for anti-tumor activity, but no practical application has been found. Although many health-food stores sell germanium products, it is illegal to market them with therapeutic claims. The FDA has banned importation of germanium products intended for human consumption and has seized germanium products from several U.S. manufacturers. Germanium supple- ments have caused irreversible kidney damage and death.
Glandular extracts: These products, sold as “food supple- ments,” are claimed to cure diseases by augmenting glandular function in the body. Actually, they contain no hormones and therefore have no pharmacologic effect on the body. If they did produce such an effect, they would be dangerous for self-medication. The theory behind their use—like the magical thinking of primitive tribes—is that enzymes or other substances found in animal organs will strengthen or rejuve- nate human body processes that involve similar substances. (See “doctrine of signatures” in Glossary.) Thus an extract of animal pancreas might be recommended to strengthen a person’s pancreas, an animal heart extract might be suggested for the human heart, and so on. When present in homeopathic dilution, these substances have no effect on the body. Even in higher concentration, when taken by mouth, they are digested by the stomach and intestines. Because they are proteins, they are broken down into their component amino acids so that no “glandular substances” actually reach the cells they are supposed to help.
Glucosamine and condroitin sulfate: Glucosamine is a basic building block of the cartilage that cushions the joints. Chondroitin is a component of that cartilage. Both are manu- factured by the body. Glucosamine supplements (derived from shellfish shells) and chondroitin sulfate supplements (gener- ally derived from cow cartilage) have been studied. Some research suggests that glucosamine may relieve arthritis pain, but the largest and best-designed studies have demonstrated no benefit. Chondroitin appears to be useless and can cause bleeding in people who have a bleeding disorder or take a blood-thinning drug.68
Granola: Granola is the common term used to describe breakfast cereals and candy bars composed largely of oats plus other grains, dried fruits, seeds, and nuts. Touted as “natural” and rich in nutrients, granola products tend to be high in sugar (usually brown sugar and/or honey), fats (from vegetable oils, nuts, seeds, and coconut), and calories.
Guarana: An herb that contains a significant amount of caffeine, a fact that is sometimes omitted on product labels.
Inositol: Contrary to popular claims, supplements of inositol will not alleviate baldness, reduce blood cholesterol levels, or aid in weight loss. Inositol is not a B vitamin, and the body can manufacture all it needs. Even if it were a vita- min, supplements would be unnecessary because it is readily available in our food supply.
*Kelp: Kelp is a seaweed common in the Japanese diet. Tablets of kelp are prepared from dried seaweed and promoted in health-food stores as a weight-reduction aid; a rich source of iodide; an energy booster; and a “natural” cure for certain ailments, including goiter (enlargement of the thyroid gland). Kelp is high in iodine, a mineral needed to prevent goiter. However, iodized salt furnishes an adequate supply of this mineral at a fraction of the cost of kelp. Excess iodine can be detrimental.
Lecithin: Lecithin is manufactured by the liver and occurs in many foods, including soybeans, whole grains, and egg yolks. Claims that lecithin supplements can dissolve blood cholesterol, rid the bloodstream of undesirable fats, cure ar- thritis, improve brain power, and aid in weight reduction are unsupported by scientific evidence.
*Melatonin: Melatonin is a hormone produced from the amino acid l-tryptophan by the pineal gland, a small structure near the center of the brain. Its secretion increases when it is dark, which signals the body that it is time to sleep. In most people, blood levels peak near puberty and steadily decline with age. A Cochrane Review69 has concluded that (a) melatonin is effective in preventing or reducing jet lag, (b) occasional short-term use appears to be safe, and (c) it is most useful for adult travelers flying across five or more time zones, particularly in an easterly direction. Claims that melatonin supplements can improve sex life, protect against many diseases, or reverse the aging process are unsubstanti- ated. Adverse reactions have been reported, and it is not known whether melatonin is safe for long-term use.
Octacosanol: This substance, found in wheat germ oil and many other plant oils, is not essential in the human diet. Claims that it improves stamina and endurance, reduces blood cho- lesterol, and helps reproduction have not been substantiated.
PABA (para-aminobenzoic acid): PABA is a vitamin for bacteria, but not for humans. It is claimed that oral dosages can prevent or reverse the graying of hair, but no scientific evidence supports this claim.
Papain: Papain, an enzyme present in papaya extract, is promoted as a cure for gum disease and an aid to digestion and weight-reduction. When taken by mouth, papain is rapidly destroyed in the digestive tract. Its only significant use is as a meat tenderizer; it can be added to meats before they are consumed and while the enzyme is still chemically active.
*Propolis: Propolis (“bee glue”) is a resinous material bees collect and use to fill cracks in their hives. It has mild antibac- terial properties but has not been scientifically demonstrated to have practical use as a medication. Skin inflammation has occurred among users of cosmetics containing propolis, and
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mouth ulcers have been reported after the use of propolis- containing lozenges.
*Protein supplements: Protein powders, tablets, and liq- uids have been advertised as strength-promoting and especially important to athletes. These claims are incorrect. The RDA for protein is easily obtained by eating a well-balanced diet. Sup- plements provide no additional benefit and, in large amounts, can cause nutritional imbalances and kidney problems.
*Raw milk: Raw milk is milk in its natural (unpasteurized) state. Pasteurization is done to destroy any disease-producing bacteria that may be present. Health faddists claim that pas- teurization destroys essential nutrients. Although about 10% to 30% of the heat-sensitive vitamins (vitamin C and thiamine) are destroyed in the pasteurizing process, milk is not a signifi- cant source of these nutrients. Contaminated raw milk can be a source of harmful bacteria, such as those that cause undulant fever, dysentery, salmonellosis, and tuberculosis. “Certified” milk, obtained from cows certified as healthy, is unpasteurized milk with a bacteria count below a specified standard, but it still can contain significant numbers of disease-producing or- ganisms. The risks of raw milk are not related to mishandling; thus the only way to avoid them is not to consume the product. In 1987 the FDA ordered that milk and milk products in final- package form for human consumption in interstate commerce be pasteurized. The sale of raw milk has been banned in about half the states.
Resveratrol: This compound, found largely in the skins of red grapes, is touted as an antioxidant and a phyto-estrogen. Laboratory tests have demonstrated that it may help prevent cardiovascular disease and cancer. However, further studies in animals and humans are necessary to determine whether resveratrol supplementation makes sense.70
*RNA/DNA: Supplements of these genetic materials are claimed to rejuvenate old cells, improve memory, and prevent skin wrinkling. When taken orally, they are inactivated by the digestive process. Even if they could be absorbed and reach the cells, they would not improve health because for proper growth, human cells utilize human nucleic acids, not those from lower animals. Ingesting large amounts can raise blood uric acid levels, which can cause problems.
Royal jelly: Royal jelly is food for queen bees. Claimed to increase endurance, it has been recommended for athletes. It is also advertised as rich in calcium pantothenate (claimed to be “vitamin B5”), a supposed antioxidant-antistress nutri- ent used also in “miracle” skin creams and hair tonics. These claims are unsubstantiated.
Rutin: A chemical related to the bioflavonoids, rutin is not a vitamin for humans. It is illegal for supplement labels to carry nutritional claims for rutin, but it is often included in multivitamins by sellers who wish to create the impression that their product is “more complete.”
Sea salt: Proponents of sea salt claim that it is unrefined and therefore more nutritious than ordinary salt, but actually it is refined to remove impurities. Sea salt contains as much sodium as table salt and also variable amounts of iodine, but table salt can have the advantage of being iodized with the correct dose. Salts said to be “seawater concentrates” have
been marketed with false claims that they can cure cancer, diabetes, and many other diseases.
*Spirulina: Spirulina is a blue-green alga, some species of which have been used as a dietary staple in several parts of the world. Spirulina is similar to soybeans in nutrient content. It contains protein of fair quality plus some other nutrients, but nothing that cannot be obtained much less expensively and more hygienically from conventional foods. Despite propo- nents’ claims, spirulina has no value as a weight-reduction aid or as a remedy for any disease. Law enforcement agencies have ordered several companies to stop making illegal therapeutic claims for spirulina products, but others continue to do so. Some products sold as “spirulina” contain no spirulina, and some have been found to be contaminated with insect parts, other filth,6 and toxins called microcystins.71
Superoxide dismutase (SOD): SOD is an enzyme pro- moted as an “antioxidant” that supposedly protects body tissues against environmental contaminants, heart disease, cancer, and arthritis. The body has its own supply of functioning an- tioxidants, including various enzymes and vitamins C and E. Enzymes taken orally are digested in the gastrointestinal tract.
Wheat germ: Wheat germ is a source of protein, several B vitamins, vitamin E, some minerals, and fiber. It is neither a cure-all nor a dietary essential. It is amply provided in whole wheat products. As a supplement, it is relatively high in calories and cost.
Wheat grass juice: A juice, made from sprouted wheat berries, said to be high in chlorophyll and claimed to “cleanse” the body, neutralize toxins, slow the aging process, and pre- vent cancer. Its principal proponent, the late Ann Wigmore, attributed these supposed benefits to enzymes in the plant that supplement the body’s enzymes when ingested. These claims are false. The enzymes in foods are not absorbed into the body but are digested like other proteins. Even if they could be absorbed intact, enzymes from plants would not enhance the metabolic processes of humans.
*Zinc gluconate. A study published in 1996 sharply boosted sales of zinc gluconate lozenges for treating colds. The study compared 50 patients who used them with 50 who took a placebo.72 The zinc dosage was 13.3 mg every 2 hours with an average of six per day. Blinding was not perfect, however, because the zinc lozenges tasted more astringent than the place- bos. The zinc-treated patients had fewer cold symptoms but had higher frequencies of bad taste, mouth irritation, and nausea. Complete symptom resolution (as reported by the patients) took 4.4 days for the zinc group and 7.6 for the control group. However, in 1997 The Medical Letter73 reviewed seven other studies and concluded that three had positive results and four found no benefit. It concluded: “Treatment with large doses of zinc might decrease the symptoms and shortened the duration of the common cold, but properly blinded confirmatory stud- ies are needed. The long-term safety of taking zinc in doses higher than the Recommended Dietary Allowances has not been established.” (The adult RDAs are 15 mg for men and 12 mg for women.) The manufacturer of a zinc gluconate nasal gel (Zicam) is facing lawsuits by many people who believe the product destroyed their sense of smell.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 213
raw Foods aNd “JuiciNg” Raw foodism is a lifestyle that promotes the consumption of uncooked, unprocessed, and often organic foods as a large percentage of the diet. Advocates typically believe that the greater the percentage of raw food in the diet, the greater the health benefits. Raw food diets may include a selection of raw fruits, vegetables, nuts, seeds, sprouted whole grains, eggs, and non-pasteurized dairy products, such as raw milk, raw milk cheese, and raw milk yogurt. Some raw food dieters include meat and fish. Raw food advocates typically believe that uncooked foods and juices are healthier because they contain more nutrients than cooked or processed foods. However, as noted on page 200, such losses are not usually signifi- cant to people’s overall diet. Some raw food advocates claim that cooking produces harmful chemical toxins. However, critics have noted that cooking makes some foods more digestible and that uncooked foods are far more likely than raw foods to contain toxic substances. Juicing involves grinding fruits and vegetables into tiny pieces that are spun to separate the juice from the fiber-containing pulp. It may be part of a raw food diet or done separately. Since the fiber in fruits and vegetables is an important part of a balanced diet, there is no reason to remove it while making juice. There is nothing wrong with including extracted juices in a diet that is adequate
in fiber. But promoting them as alternatives to whole foods or as powerful healing agents is irresponsible. Many raw food and juicing advocates claim that un- cooked foods are superior to cooked foods because they are “live” and contain “active enzymes” that promote general health, boost the immune system, and can fight a wide range of diseases. These claims are unsubstantiated and lack a plausible rationale. The enzymes in plants do not influence biochemical reactions within the body’s cells because they are destroyed by digestion rather than absorbed intact into the body.65
“mediciNal” use oF herbal products
Herbal remedies have been used throughout history. The Persians, Romans, Greeks, Hebrews, and Babylonians were familiar with the practice of herbal medicine. By trial and error, accident or design, people concluded that certain roots, plants, barks, and seeds possessed medici- nal properties. In the second century bce the Egyptians used myrrh, cumin, peppermint, caraway, fennel, and oil of cloves for various ailments. Licorice was especially esteemed. Sarsaparilla, the dried root of the Smilax, a climbing vine native to tropical regions of the Americas, was introduced in Europe in the 16th century as a tonic for venereal disease and later for chronic rheumatism, scrofula, and skin disease. In the latter part of the 19th
√ Consumer Tip
1. “Even if a product may not help me, it at least won’t hurt me.” It’s best not to assume that this will always be true. When consumed in high enough amounts, for a long enough time, or in combination with certain other substances, all chemicals can be toxic, including nutri- ents, plant components, and other biologically active ingredients.
2. “A product is safe when there is no cautionary in- formation on the product label.” Dietary supplement manufacturers may not necessarily include warnings about potential adverse effects on the labels of their products. If consumers want to know about the safety of a specific dietary supplement, they should contact the manufacturer of that brand directly. It is the manu- facturer’s responsibility to determine that the supple- ment it produces or distributes is safe and that there is substantiated evidence that the label claims are truthful and not misleading.
3. “When I see the term ‘natural,’ it means that a product is healthful and safe.” Consumers can be misled if they assume this term assures wholesomeness or indicates that these substances necessarily have milder effects that make them safer to use than drugs. The term “natural” on labels is not well defined and is sometimes used am- biguously to imply unsubstantiated benefits or safety. For example, many weight-loss products claim to be “natural” or “herbal” but this doesn’t necessarily make them safe. Their ingredients may interact with drugs or may be dangerous for people with certain medical conditions.
4. “A recall of a harmful product guarantees that all such harmful products will be immediately and completely removed from the marketplace.” A product recall of a dietary supplement is voluntary; and while many manufacturers do their best, a recall does not necessarily remove all harmful products.
Don’t Make These Questionable Assumptions about Dietary Supplements and Herbs74
Part Three Nutrition and Fitness214
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Table 11-5
Cat’s claw. Although cat’s claw appears to have potential for treating certain viral and inflammatory diseases, more clinical research is needed to determine its effectiveness and long-term safety.
Echinacea. Test-tube evidence suggests that echinacea stimulates immune processes, but it has not been proven useful by well-designed human studies.75 Echinacea should not be taken by people with an autoimmune disease (such as type 1 diabetes, rheumatoid arthritis, or multiple sclerosis) or a disease that causes immune suppression. Quality control is also problematic.
Ephedra. Products containing ephedrine alkaloids have been marketed as weight-loss aids and athletic enhancers. Although some products of this type may have slight posi- tive effects, they have also been associated with death, heart attacks, stroke, seizure, and serious psychiatric illness in young adults.76 The FDA has banned their sale as dietary supplements and is battling in court to enforce the ban.
Garlic. Allicin, a component of garlic, has been shown to inhibit the production of cholesterol by the liver. Popu- lation studies have found an association between lower cholesterol levels and increased intake of garlic, onions, and related vegetables. However, most well-designed clini- cal trials have not found a cholesterol-lowering benefit for garlic supplements, and its anticoagulation property may undesirably enhance that of other blood-thinners.
Ginkgo. Ginkgo biloba contains compounds that can in- crease blood flow to the brain. However, there is no evidence that ginkgo products can cure or prevent Alzheimer’s disease or generally improve mental function.77 A recent study found that ginkgo extract did no better than a placebo in prevent- ing mental decline among adults ages 72 to 96 with normal cognition or mild cognitive impairment. The study involved more than 3000 people who, for about 6 years, were tested twice a year for memory, attention, language, and several other abilities.78 Ginkgo’s anticoagulation property may undesirably enhance that of other blood-thinners.
Ginseng. Ginseng may help improve sleep, appetite, and work efficiency. However, it can raise blood pressure, and many ginseng products contain little or none of the active ingredient.
Goldenseal. Goldenseal is claimed to have laxative, anti- inflammatory, and anti-hemorrhagic properties. It has many adverse effects, and its use is not supported by adequate research.
Green tea. Epidemiologic and animal studies suggest that green tea may help prevent atherosclerosis. However, clinical trials are needed to accurately assess its usefulness.
Kava. Small studies suggest that kava may be useful for treat- ing anxiety, stress, and restlessness. However, chronic, heavy use can cause adverse effects. In 2002, the FDA warned consumers that kava products can cause severe liver injury.79
Milk thistle. Studies suggest that milk-thistle extract may have a useful role in treating various liver diseases. However, most of the supporting research has not been well-designed and the best-designed studies have not demonstrated benefit.80
Saw palmetto. Saw palmetto is widely believed to relieve symptoms of benign enlargement of the prostate gland. A survey of Consumer Reports81 readers found that about half improved, compared to about 75% of prescription drug users. However, a 2009 Cochrane review82 of 30 trials concluded that saw palmetto has little or no efficacy over placebo. This conclusion differed from that of previous Cochrane reviews because two recent high-quality clinical trials showed no benefit.
St. John’s wort. St. John’s wort is widely promoted as an antidepressant. However, the two most important studies found no benefit against moderate or severe depression.83,84 Moreover, researchers who tested 54 commercial St John’s wort products purchased in Canada and the United States found only two products with a total hypericin content (hypericin plus pseudohy- pericin) within 10% of the amount stated on the label. (These sub- stances are thought to reflect product potency.) The percentage of the label claim varied from 0% to 108% for capsule products, 31% to 80% for tablet products, and total hypericin content of tinctures also varied widely. On average, most products tested contained half of the labeled amount of hypericin.85 St. John’s wort should not be combined with standard antidepressants or used by women who are pregnant or are breastfeeding.
Valerian. Valerian appears to exert mild sedative-hypnotic effects, but most supportive studies have been methodologi- cally flawed. A U.S. Pharmacopeia expert panel has concluded that there is not enough evidence to support its use for treating insomnia.86
century its use as a medicine was abandoned, but it became popular as a syrup for soft drinks. Although a few plant extracts have been used in modern medical practice, most have been replaced by products that are safer or more effective or have fewer unpleasant side effects. For example, reserpine, found naturally in snakeroot (rauwolfia), was one of the earli- est effective remedies against high blood pressure and
was used extensively during the 1950s and 1960s until better synthetic drugs were developed. Curare, used to paralyze muscles during surgical procedures, has been replaced by synthetic derivatives. Powdered willow bark, discovered during ancient times to relieve pain, has evolved into today’s aspirin. Foxglove leaves contain digitalis, a drug used to treat heart failure and abnormal heart rhythms. However, the use of dried leaves has given
Chapter Eleven Nutrition Fads, Fallacies, and Scams 215
way to extracts and synthetic drugs whose dosages are precisely controlled. Today, Americans spend billions of dollars per year for herbal capsules and tablets, bulk herbs, and herbal teas used for supposed medicinal qualities. Most are purchased over-the-counter, but some are prescribed by practitioners. Many herbs contain hundreds or even thousands of chemicals that have not been completely cataloged. While some may ultimately prove useful as therapeutic agents, others could well prove toxic. Most herbal products sold in the United States are not standardized, which means that determining the exact amounts of their ingredients can be difficult or impos- sible. Moreover, many herbal practitioners are not quali- fied to make appropriate diagnoses or to determine how herbs compare to proven drugs. Many herbal products are marketed as “dietary supplements,” even though they have little or no nutri- tional value. No legal standards exist for their processing,
harvesting, or packaging. In many cases, particularly for products with expensive raw ingredients, contents and potency are not accurately disclosed on the label. Many products marketed as herbs contain no useful ingredients, and some even lack the principal ingredient for which people buy them. Some manufacturers are trying to develop industrywide quality-assurance standards, but possible solutions are a long way off. Herbs in their natural state can vary greatly from batch to batch and often contain chemicals that cause side effects but provide no benefit. Surveys conducted in the United States have found that the ingredients and doses of various products vary considerably from brand to brand and even between lots of the same product.88
For example, researchers at the University of Arkansas tested 20 “supplement” products containing ephedra (ma huang) and found that half the products exhibited discrepancies of 20% or more between the label claim and the actual content, and one product contained no
Quality oF sources oF iNFormatioN about herbs aNd other Natural products
Table 11-6
Recommended Sources
Natural Medicines Comprehensive Da- tabase (www.naturaldatabase.com)
AboutHerbs (www.mskcc.org/mskcc/ html/11570.cfm)
ConsumerLab.com (www.consumerlab.com)
The Natural Pharmacist (consumerlab.com/tnp.asp)
NIH Office of Dietary Supplements (ods.od.nih.gov)
Review of Natural Products www.factsandcomparisons.com
Herbal Medicines, 3rd Edition87
Nonrecommended Sources
AltCareDex System HealthNotes Herbal Safety (University of Texas) Natural Standard
Commission E Report PDR for Herbal Medicines, 3rd Edition
Comments
More than 1000 entries about herbs and dietary supplements. Thoroughly researched and referenced; frequently updated. Best information source on side effects and interac- tions with drugs and other products. Costs $92/year for online access or book, or $132/year for both.
More than 300 entries about herbs, dietary supplements, and “alternative” cancer treat- ments. “Professional” and consumer versions are provided, but most of the profession- al information is readily understandable by laypersons. Less detailed than the Natural Medicines database, but quite reliable. Free.
Tests whether popular products contain the amounts of ingredients listed on their label and provides information about their usefulness. Some information is free; other infor- mation requires a nominal subscription or temporary access fee.
Covers several hundred substances plus many “complementary and alternative treat- ments.” Very scholarly but not updated since 2003. Available free of charge to ConsumerLab subscribers and other sites that license it. (Use Google to find them.)
Provides more than 60 comprehensive Dietary Supplement Fact Sheets.
Covers more than 350 products. Available as book (6th edition, 2010), printed newsletter, and online database. Some libraries provide free online access.
Book contains 152 thoroughly referenced and highly reliable herbal monographs.
These four databases offer huge amounts of research-based information without suffi- cient interpretation to provide practical advice. Some presentations are not sufficiently critical. Natural Standard, which is fee-based, is the most comprehensive. The others are free.
Both books are comprehensive but rely too much on anecdotal evidence. The herbal PDR contains bizarre recommendations for homeopathic products.
Part Three Nutrition and Fitness216
ephedra alkaloids. The products were marketed as “energy boosters” and/or “thermogenic” diet aids, even though no published clinical trials substantiated that they are safe or effective for these purposes. The researchers also noted that hundreds of such products were marketed and that their number exceeded that of conventional pre- scription and nonprescription ephedra products, which are FDA-approved as decongestants.89
To make a rational decision about an herbal product, it would be necessary to know what it contains, whether it is safe, and whether it has been demonstrated to be as good or better than pharmaceutical products available for the same purpose. For most herbal ingredients this information is incomplete or unavailable. “Popularity” is not a reliable sign of effective- ness. In 1999, Consumer Reports81 asked its readers in the United States and Canada to rate the standard and “complementary” therapies they had used most often for the two most serious or bothersome medical condi- tions they had encountered during the previous 2 years. Prescription drugs scored significantly better than herbs for each of the reported problems where both were used. Table 11-6 rates several of the best-known sources of information about herbs and other natural products. Dr. Harriet Hall observed that only about 5% of the substances listed in the 2007 Natural Medicines Com- prehensive Database90 were rated effective and most of these were either vitamins, minerals, or substances that were also ingredients in standard drugs. Establishing that a substance is clinically effective does not ensure that products containing the substance will be appropriately formulated. An evaluation of herbal products from 20 retail stores in and around Minneapolis concluded that only 43% of 880 products were labeled with the ingredients and dosage that had been used in published studies of the ingredients. The chosen herbs were echinacea, St. John’s wort, ginkgo biloba, garlic, saw palmetto, ginseng, goldenseal, aloe, Siberian ginseng, and valerian. The actual ingredients were not measured, but the survey indicated that many manufacturers failed to formulate their products to cor- respond with available research data.91
ConsumerLab.com, which has tested over 2600 products since 1999, reported in 2010 that 19% of the vitamins and minerals, 22% of the other supplements, and 47% of the herbals failed their evaluations. The most common reason for the failure was too little or none of the main ingredient. The other problems included too much active ingredient; the wrong ingredient; potentially dangerous or illegal ingredients; contamination with heavy metals, pesticides, or pathogens; “spiking” with
unexpected ingredients; poor disintegration (which af- fects absorption); and misleading or incomplete product information. Even when a botanical product contains ingredients that are potentially effective, it may not be practical to use. Garlic, for example, has been demonstrated to lower cholesterol. However, prescription drugs are more potent for this purpose, and garlic has anticoagulant properties. No data are available to indicate the risk of combin- ing garlic with other widely used products (vitamin E, ginkgo, fish oil, and aspirin) that can interfere with blood clotting. The entry of drug companies into the herbal market- place may result in standardization of dosage for some products, and recent public and professional interest in herbs is likely to stimulate more research. However, with safe and effective medicines available, treatment with herbs rarely makes sense, and many of the conditions for which herbs are recommended are not suitable for self-treatment. The National Council Against Health Fraud92 rec- ommended that the FDA establish a special category of over-the-counter drugs called “Traditional Herbal Remedies.” These could then be marketed with less- than-standard proof of effectiveness if: (a) reasonable evidence exists that they are safe and effective; (b) labels identify the name and quantity of each active ingredient; (c) indications are restricted to nonserious, self-limiting conditions; (d) labels contain adequate directions for use, including a warning about inappropriate self-treatment; and (e) adverse reactions are reported. Herbal teas may have a single ingredient or may be blends of as many as 20 different kinds of leaves, seeds, and flowers. The Medical Letter93 has identified the following as potentially troublesome: buckthorn bark, burdock root, catnip, chamomile, devil’s claw root, ginseng, horsetail, hydrangea, Indian tobacco, jimson- weed, juniper berries, licorice root, lobelia, mistletoe, nutmeg, pokeweed (especially the root), sassafras root bark, senna leaves, shave grass, and wormwood. A 1993 FDA report94 stated that chaparral, comfrey, germander, jin bu huan, lobelia, ma huang, willow bark, and yohimbe have been associated with illness or injury. Consumer Reports95 includes bitter orange, chaparral, kava, skull- cap, and snakewood in its “Dirty Dozen” list of supple- ment and herbal products to avoid. Pennyroyal, taken with the hope of inducing menstruation or an abortion, has caused serious toxicity and death.96 Many traditional Chinese and ayurvedic medicinal herbs have been found to be contaminated with heavy metals or other toxic substances.97
Chapter Eleven Nutrition Fads, Fallacies, and Scams 217
Nutrition-related fads and myths have existed throughout the ages. It has been alleged that foods can sustain or interfere with general health and that many foods can cause or cure various illnesses. Although the science of nutrition offers the potential to curb faddism, the parallel development of mass communication has enabled faddists to reach vast audiences of unsuspecting people. Food faddism’s basic premise, traceable to ancient times, is that diet is the primary factor in health, disease, intellect, behavior, and mortality. Many cultures have believed that “we are what we eat.” The ancient doctrine of correspondences held that “like is like” or that “like produces like.” Thus eating a tiger’s heart would produce courage, and eating its genitals would enhance virility. The ancient Egyptians believed that all diseases were caused by what people ate and that dietary regimens were curative. They preserved corpses so that a winged creature could recognize them and carry their soul to the sun god for eternal circulation in the heavens. Believing that the anus was the center for disease and decay, the Egyptians were also preoccupied with enemas, drenches (drinking large quantities of water), and bowel movements to cleanse the colon. The Greeks ate grasshoppers for liver disorders and believed that fevers were helped by eating seven bugs from the skin of a bear. The Romans thought lettuce cleansed the senses, garlic gave physical strength, and truffles increased sexual potency. They also believed that good health came only with sacrifice, discomfort, self-discipline, and dour at- titudes—concepts still common among faddists. “Modern” food faddism began with the preaching of Syl- vester Graham (1794–1851), who mixed religion with a zeal for the natural, “uncomplicated” life. Graham was ordained as a Presbyterian minister in 1826 but was influenced by Philadelphia’s Bible Christian Church. He practiced home- opathy and lectured on temperance, cholera, fresh air, bathing, and sexual restraint. He was one of the first American “health reformers” to reach large audiences. His initial focus on the evils of alcohol soon expanded to other health concerns. “The simpler, plainer, and more natural the food,” he said, “the more healthy, vigorous, and long-lived will be the body.” Among the prohibited foods were salt and other condiments (these and sexual excesses caused insanity), cooked vegetables (against God’s law), and chicken pies (caused cholera). Graham’s most vigorous attacks were against “unnatu- ral” substances such as meat, white-flour products, and water consumed at mealtimes. He also claimed that people did not bathe enough and needed external applications of cold water at least weekly. Partly because of his advocacy, Saturday night baths and setting-up exercises before open windows became common practices. Although Graham died at the early age of 57, the cracker that bears his name is still with us. James Caleb Jackson (1811–1895) was a farmer before he became a physician by apprenticeship. His health had failed due to heart and kidney trouble and dyspepsia. He attributed his recovery to drinking 30 to 40 glasses of water daily. In
1858 he opened a sanitarium to provide “water cures” both internally and externally. At this facility women were encour- aged to wear bloomers (the standard reformist dress) instead of a corset. They were also relieved of their false hair; fed fruits, Graham crackers, and bread; and urged to take naps and walks. Jackson also advocated phrenology and vegetarianism. To supplement the Graham crackers, he prepared broken bits of rock-hard baked wheat with water, which he called Granula. He also marketed a cereal coffee called So Mo and several other items. These may have been the first prominent “health foods” sold in the United States.98
John Harvey Kellogg (1852–1943) reportedly ate his way through medical school on a diet of apples and Graham crackers. He belonged to a Seventh-day Adventist group that had founded a religious colony and health sanitarium at Battle Creek, Michigan. He and his brother Will were probably the first to make $1 million from food faddism. Under John’s leadership, the Battle Creek Sanitarium attracted hordes of wealthy clients whose intestines he “detoxified” with enemas and high-fiber diets. His 1217-page book, Rational Hydro- therapy, recommended a “water cure” for virtually every ailment. While trying to develop a dried bread product upon which his clients could exercise their teeth without breaking them, Kellogg hit upon the idea of a wheat flake. By 1899 the flakes had evolved into a cereal-based company that soon had many competitors. One was Charles W. Post, a former Kel- logg patient, who ground up wheat and barley loaves, called his new product “grape nuts,” and marketed it as a cure for appendicitis, malaria, consumption (tuberculosis), and loose teeth. Their enterprises were the roots of two of today’s giant cereal producers: the Kellogg Company and the Post Division of General Foods. Bernarr Macfadden (1868–1955) was the first faddist to use mass-media techniques to amass a fortune (see Chapter 14). He taught that medical care (which he steadfastly avoided) should be rejected in favor of “natural” methods. D.C. Jarvis, M.D. (1881–1966), wrote that body alkalinity was the principal threat to American health and that honey and apple cider were the antidotes. False claims in his book—which is still widely sold—were the basis for an FDA seizure of a product called Honegar. Gayelord Hauser (1895–1984) promised to add years to people’s life with five wonder foods: skim milk, brewer’s yeast, wheat germ, yogurt, and blackstrap molasses. He lec- tured frequently and was a partner in a company that marketed products bearing his name. Hauser wrote a syndicated news- paper column and more than a dozen books reported to have sold close to 50 million copies here and abroad. One book, Look Younger, Live Longer, led the bestseller list in 1951. That same year, the FDA seized copies of the book, claiming they were being used to promote sales of blackstrap molasses as a cure-all. The court readily agreed that the molasses was misbranded by many false claims in the book. Continued on page 218
Historical Perspective
Some Roots of Today’s Food Faddism
Part Three Nutrition and Fitness218
Historical Perspective
Some Roots of Today’s Food Faddism—Cont’d.
Adolphus Hohensee (1901–1967) began his training in nutrition with a job as a soda jerk. After dabbling in real estate (with time in jail for mail fraud) and the field of transportation (during which time he was arrested for passing bad checks), Hohensee resumed his education. In 1943 he acquired an Honorary Degree of Doctor of Medicine from a nonaccredited school and followed this with Doctor of Naturopathy degrees from two schools that he did not attend. In 1946 he acquired a chiropractic license in the state of Nevada. A master showman, Hohensee could lecture for hours about the terrible American diet that would stagnate the blood, corrode blood vessels, erode the kidneys, and clog the intes- tines. He said that most people had intestinal worms, which, fortunately, could be cured by his special cleansing. He prom- ised a long life to those who consumed his wonder products. Repeated prosecution by the FDA made him more cautious about selling his products during lectures, but his promotion of the gamut of food myths sent his audiences flocking to nearby health-food stores whose shelves just happened to be well-stocked with his product line. In 1955, reporters caught Hohensee eating a meal of forbidden foods after one of his lectures. In 1962 he began serving an 18-month prison term for selling honey with false claims. But neither of these setbacks dampened his enthusiasm or that of his loyal followers. Lelord Kordel (1908–2001), author of about 20 books, recommended high-protein foods, lecithin (“the miracle nutri- ent”), and high-dosage vitamin and mineral supplements for everyone. He began marketing supplements in 1941. In 1946 he was convicted of misbranding and was fined $4000. One product in the case was Gotu Kola, an herbal tablet said to restore youth and “produce erect posture, sharp eyes, velvety skin, limbs of splendid proportions, deep chests, firm bodies, gracefully curved hips, flat abdomens” and even “pleasing laughter.” Thirteen other products were falsely claimed to be effective against heart disease, liver troubles, tuberculosis, impotence, and various other problems. Kordel had a brush with the FTC in 1957 and two more with the FDA in 1961. In 1963, when he was president of Detroit Vital Foods, Inc., products shipped by the company were found to be misbranded because they were accompanied by Kordel publications that falsely claimed that nutritional products could treat practically all diseases. After the appeals process ended in 1971, Kordel was fined $10,000 and served 1 year in prison. Catalogs from Vital Foods, Inc., described him as “America’s leading vitamin and diet expert” and claimed that he had never been ill. During the 1950s and early 1960s government agencies carried out more than 200 successful actions against misbrand- ing. Several prominent faddists were sentenced to prison, and the courts ruled that any false message given in the context of a sale could be considered part of a product’s labeling. The budding health-food industry soon reorganized to get around the law. Most supplement manufacturers stopped labeling their products as effective against specific diseases. Industry emphasis shifted somewhat from “miracle” drugs to “nutrition
insurance,” an approach that tends to attract little regulatory attention. “Specialization” developed whereby most publicists have no direct financial tie to the sale of specific products. This enables their claims to be protected by the doctrines of freedom of speech and freedom of the press.7 The leading publicists have included Adelle Davis (1904–1974), Carl- ton Fredericks (1910–1987), and Robert C. Atkins, M.D. (1930–2003). Davis was the first “authority” among modern food faddists who had any formal professional background. She was trained in dietetics and nutrition at the University of California at Berkeley, and received a Master of Science degree in biochemistry from the University of Southern Cali- fornia School of Medicine. Her four main books sold a total of 10 million copies: Let’s Eat Right to Keep Fit, Let’s Get Well, Let’s Cook It Right, and Let’s Have Healthy Children. She criticized the American diet as excessively high in salt; loaded with refined sugar; and contaminated by pesticides, growth hormones, and preservatives. She claimed modern food processing destroys vital nutrients. She proposed that people eat organic fruits and vegetables, whole wheat bread, wheat germ, vitamin supplements, certified raw milk, fresh stone-ground whole-grain bread or cereal, and other “health food” products. Although Davis often cited references to back what she said, investigators found that many of them did not actually support her claims. Moreover, she was sued successfully by parents of two children who were seriously harmed by her advice.99
Fredericks was described on some of his book jackets as “America’s foremost nutritionist.” He considered himself an expert and gave copious advice in books and articles for health-food publications. However, he had virtually no nutrition or health science training. He graduated from the University of Alabama in 1931 with a major in English and a minor in political science. In 1937 he began writing adver- tising copy for a vitamin company. He also gave sales talks, adopting the title of “nutrition educator.” In 1945, after investigators found that he had been diag- nosing patients and prescribing vitamins for their illnesses, Fredericks pleaded guilty to practicing medicine without a license and paid a small fine. He then obtained a master’s de- gree in education and a Ph.D. in communications at New York University. His doctoral thesis was based on the responses of listeners to his radio programs. For 30 years, beginning in 1957, he hosted “Design for Living,” a daily show on radio station WOR in New York City. Atkins, who practiced in New York City, claimed that “nutrition has been useful in just about every condition I have treated. . . . And there are probably herbal answers for every condition for which there is a pharmacological answer.” He was one of the first physicians to use the term “complementary medicine.” He considered Fredericks to have been his men- tor and took over Fredericks’ radio program after his death.7
Atkins advocated a low-carbohydrate (high-fat) diet that is still widely used today (see Chapter 12).
Chapter Eleven Nutrition Fads, Fallacies, and Scams 219
macrobiotic diets
Macrobiotics is a quasireligious philosophical system founded by the late George Ohsawa. (Macrobiotic means “way of long life.”) The system advocates a vegetar- ian diet in which foods of animal origin are used as condiments rather than as full-fledged menu items. The optimal diet is achieved by balancing “yin” and “yang” foods. Ohsawa outlined a 10-stage “Zen” macrobiotic diet in which each stage is progressively more restrictive. The diet was alleged to enable individuals to overcome all forms of illness, which Ohsawa said were due to excesses in diet. Current proponents espouse a diet that is less re- strictive but still can be nutritionally inadequate. They recommend whole grains (50% to 60% of each meal), vegetables (25% to 30% of each meal), whole beans or soybean-based products (5% to 10% of daily food), nuts and seeds (small amounts as snacks), miso soup, herbal teas, and small amounts of white meat or seafood once or twice a week. The leading American proponent has been Michio Kushi, a former student of Ohsawa, who founded the Kushi Institute in Becket, Massachusetts. Institute pub- lications recommend chewing food at least 50 times per mouthful (or until it becomes liquid), not wearing syn- thetic or woolen clothing next to the skin, avoiding long hot baths or showers (unless you have been consuming too much salt or animal food), having large green plants in your house to enrich the oxygen content of the air, and singing a happy song every day. Kushi100 claims that macrobiotic eating can help prevent cancer and many other diseases. He also presents case histories of people whose cancers have supposedly disappeared after they adopted the macrobiotic diet. Dwyer101 counters that there is no scientific evidence of benefit, and that the diet itself can cause cancer patients to undergo serious weight loss. Raso,102 who attended a macrobiotic seminar for professionals, reported that astrologic conditions, weather conditions, and a long list of other bizarre factors were said to be relevant to diagnosing patients. Lindner103 had a private consultation at the Institute as part of an assignment for American Health magazine. After examining Lindner’s face, the practitioner stated that Lindner’s kidneys were weak, he was slightly hypoglycemic, and his heart was enlarged because he ate too much fruit. He was also told that de- posits of fat and mucus were starting to build up on his intestines. In 2001, Kushi’s wife and colleague, Aveline, died of cervical cancer. According to an Associated Press obituary, she underwent standard radiation treatment when the cancer was discovered. When the cancer spread
to her bones and she was told that no standard treatment was available, she relied on acupuncture and “Eastern” methods.104
dubious diagNostic tests
Nutrition consultants, chiropractors, and small numbers of other licensed practitioners use a wide variety of tests as a basis for recommending supplements. The most widely used include hair analysis, “muscle-testing,” live-cell analysis, electrodermal testing, and a nutritional panel offered by a laboratory in Texas. Hair analysis is performed by obtaining a sample of hair, usually from the back of the neck, and sending it to a laboratory for analysis. The customer and the referring source usually receive a computerized printout that sup- posedly indicates deficiencies or excesses of minerals. Some also report supposed deficiencies of vitamins. The test usually costs from $60 to $135. Medical authorities agree that hair analysis is not ap- propriate for assessing the body’s nutritional state. It has limited usefulness as a screening procedure for detecting toxic levels of lead or other heavy metals. Hair analysis cannot diagnose vitamin deficiency because normally there are no vitamins in hair except at the root (below the skin surface). Nor can it identify mineral deficien- cies because the lower limits of “normal” have not been scientifically established. Moreover, the mineral compo- sition of hair can be affected by a person’s age, natural hair color, and rate of hair growth, as well as the use of hair dyes, bleaches, and shampoos.105
When 52 hair samples from two healthy teenagers were sent under assumed names to 13 commercial hair analysis laboratories, the reported levels of minerals varied considerably between identical samples sent to the same lab and from lab to lab. The labs also disagreed about what was “normal” or “usual” for many of the minerals. Most reports contained computerized inter- pretations that were voluminous, bizarre, and potentially frightening to patients. Six labs recommended food supplements, but the types and amounts varied widely from report to report. One report diagnosed 23 “possible or probable conditions,” including atherosclerosis and kidney failure, and recommended 56 supplement doses per day. Literature from most of the labs suggested falsely that their reports were useful against a wide va- riety of diseases and supposed nutrient imbalances.106 In 1985 the FTC secured a court order forbidding one laboratory from advertising to the public that hair min- eral analysis could be used as a basis for recommending supplements. For about 10 years, this order discouraged
Part Three Nutrition and Fitness220
other companies from advertising directly to consumers. However, many Web sites are now marketing the test. In 1999, researchers from the California Department of Health107 located nine laboratories and sent identical samples to six of them. The reported mineral levels, the alleged significance of the findings, and the recommen- dations made in the reports differed widely from one to another. The researchers concluded that the procedure was still unreliable and recommended that government agencies act vigorously to protect consumers. Muscle-testing is part of a pseudoscientific system of diagnosis and treatment called applied kinesiology (AK). AK is based on the notion that every organ dysfunction is accompanied by a specific muscle weakness, which enables diseases to be diagnosed through muscle-testing procedures. Its practitioners, most of whom are chiro- practors, also claim that nutritional deficiencies, aller- gies, and other adverse reactions to food substances can be identified by placing substances in the mouth or using glass vials that the patient holds. “Good” substances will make specific muscles stronger, whereas “bad” sub- stances will cause specific weaknesses. “Treatment” may include special diets, food supplements, acupressure, and spinal manipulation. Applied kinesiology should be distinguished from kinesiology (biomechanics), which is the scientific study of movement. The concepts of AK do not conform to scientific facts about the causes of disease. Controlled studies have found no difference between the results with test substances and with pla- cebos.108 Differences from one test to another may be due to suggestibility, variations in the amount of force or leverage involved, and/or muscle fatigue. Live-cell analysis is carried out by placing a drop of blood from the patient’s fingertip on a microscope slide under a glass coverslip to slow down the process of drying out. The slide is then viewed with a dark-field microscope to which a television monitor has been at- tached. Both practitioner and patient can see the blood cells, which appear as dark bodies outlined in white. The practitioner may also make a videotape for himself and the patient. Proponents of live-cell analysis claim that it is useful for diagnosing vitamin and mineral deficiencies, enzyme deficiencies, tendencies toward allergic reac- tions, liver weakness, and many other health problems. Dark-field microscopy is a valid scientific tool in which special lighting is used to examine specimens of cells and tissues. Connecting a television monitor to a microscope for diagnostic purposes is also a legitimate practice. However, experts believe that live-cell analysis is useless in diagnosing most of the conditions that its practitioners claim to detect. Lowell,109 who observed
several practitioners, noted that they failed to clean their microscope slides carefully between patients, which meant that dirt seen under the microscope would be misinterpreted as blood components. He also noted that one practitioner reported blood cell patterns that resulted from his microscope being out of focus. Cell changes also occur as the preparation begins to dry out. For several years, Infinity2, a multilevel company headquartered in Mesa, Arizona, marketed live-cell analysis through chiropractors, naturopaths, and “nu- tritional consultants.” In 1995 Dr. Barrett was tested by two Infinity2 distributors at a chiropractic convention. One diagnosed a mild B12 deficiency and “maldigestion” that could weaken the immune system and cause fatigue. The other said Barrett’s blood cells showed evidence of “liver toxicity,” “bacterial infection,” and “free radical damage.” The recommended “treatment” was enzyme pills, which Infinity2 marketed with claims that “en- zyme deficiency” is widespread among Americans. The company also maintained a telephone line for recording testimonials that were typed and “kept on file for future reference.” Electrodermal testing, which is discussed in Chapter 8, is done by connecting the patient to a device that sup- posedly measures “imbalances” in the flow of “electro- magnetic energy” and recommends dietary supplements, herbal products, and/or homeopathic products to correct the alleged imbalances. SpectraCell Laboratories of Houston, Texas, claims that its Comprehensive Nutritional Profile precisely measures an individual’s nutrient status more precisely than is done by standard tests. It further claims that the majority of Americans have nutrient deficiencies and that “intracellular nutrient deficiencies” even occur in over 50% of Americans who take multivitamins. The test is performed by placing lymphocytes (a type of white blood cell) from the patient’s blood into petri dishes containing various concentrations of nutrients. A growth stimulant is added and, a few days later, technicians identify the dishes in which “greatest cell growth” takes place, which supposedly points to a deficiency. Properly performed lymphocyte cultures have a legitimate role in medical practice, but they are not appropriate for general screening or for diagnosing “nutrient deficiencies” in the manner SpectraCell uses. The late Victor Herbert, M.D., J.D.,7 who helped develop the use of lymphocyte cultures for nutrition-related evaluations, stated that the test merely measures the amounts of nutrients stored in the lymphocytes at the time of the test and not whether the body has a shortage. He considered the test a gim- mick used to promote the sale of supplements.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 221
“Nutrient Deficiency” Questionnaires Some nutrition consultants and retailers use comput- ers to help them decide what to recommend. The tests usually involve completion of a dietary history and/or a questionnaire about symptoms that supposedly signify deficiency. Computer analysis of diet is a valuable tool that reputable nutritionists may find useful when appro- priate computer programs are used. However, those used by dietary supplement marketers are designed to tell everyone that they need large numbers of supplements. In 1988 the Council for Responsible Nutrition (CRN)—a supplement industry trade group—began advertising that stress and a fast-paced life made it advisable for women to take supplements. The ads contained a seven-question National Vitamin Gap Test with advice that a single “No” answer might indicate a need for supplements (Figure 11-3). However, the ques- tions were so narrowly written that many people with perfectly adequate diets would give at least one negative answer.110 The advertising campaign was launched after focus groups conducted by CRN indicated that vitamin sales had declined because people thought [correctly] they were getting sufficient nutrients from food.7
promotioN oF QuestioNable NutritioN
Food faddism is promoted through practitioners, health resorts, retail establishments, trade organizations, and media outlets. Roth111 notes that many of the activities of food faddists parallel those of scientific nutrition advocates. Temple112 has observed:
In recent years, I have examined hundreds of sales claims made when supplements are being marketed Several themes are consistently seen. One of the most common . . . is weak evidence presented as established facts. The marketers of supplements like to use scientific evidence the way a drunk uses a lamp-post: more for support than for illumination. Sometimes marketers go to the extreme and claim that their product cures almost everything, even cancer.
Freedom of speech and freedom of the press make it legal for anyone to make false or unproven health claims about a product as long as the claims are not made while selling the product. Most claims directed to the public about health foods and related products are not found on labels (where they would be illegal) but reach consumers through other channels of communication. Unsubstantiated claims appear in newspapers, magazines, books, newsletters, pamphlets, and lectures; on radio and television talk shows; and on the Internet. Many of those who make the claims have no direct con- nection with supplement manufacturers, while others are
Figure 11-3. Vitamin Gap Test. The questions are so narrowly written that many people with an adequate diet would answer “no” to one or more questions. Someone who drinks “less than three glasses of low-fat milk each day,” for example, might be obtaining milk-related nutrients by consuming equivalent amounts of yogurt, cheese, or other dairy products. Note, too, that selenium, iron, zinc, calcium, magnesium, omega-3s, and fiber are not vitamins.
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paid as “consultants.” Retailers absorb misinformation from health-food magazines, trade publications, materi- als distributed by manufacturers, and seminars sponsored by trade organizations. Many health-food stores display or distribute free literature (newsletters, flyers, and article reprints) containing claims that would be illegal on prod- uct labels. Illegal oral claims are made quite often in the privacy of health-food stores, pharmacies, practitioners’ offices, and customers’ homes (by multilevel distributors, as described in Chapter 4). Products are also promoted through the use of pseudodiagnostic tests that suppos- edly detect vitamin and mineral deficiencies, allergies, or “imbalances” that products supposedly can correct.
Books and Periodicals It is illegal for manufacturers to make therapeutic claims for products that are not recognized by experts as safe and effective for their intended use. For example, it would be illegal for a manufacturer to claim that a vi- tamin C product could prevent colds or that a mineral mixture could cure impotence. However, it is legal for claims of this type to be made in publications by “inde- pendent” authors. Thousands of books promote the use of questionable nutrition products and practices. Many magazines and newsletters cater to supplement manu- facturers through articles promoting the ingredients of their products. Claims in these publications—no matter how far- fetched—are protected by the doctrine of freedom of the press as long as there is no direct connection between the author and the manufacturer. In some periodicals, ads for supplement products are placed on pages adjacent to articles that promote their ingredients.
Nutri-Books, the largest wholesale distributor of promotional books, reminds its customers how valu- able the books can be. Its merchandising manuals, for example, have stated:113
Books and articles created the nutritional foods industry. . . . They are the number one product-promoters of our industry. Books and magazines are your “silent sales force”. . . . Books tell your customers what your products will do. They explain the ways your products may be used. Very often this is infor- mation you may not be able to give—or may not be permitted to discuss. . . . Magazines pack a double wallop. Their articles sell products, and so do their ads.
Figure 11-4 illustrates how Nutri-Books has encour- aged retailers to use books and periodicals to promote their products. The book most widely used as a sales tool today is Prescription for Nutritional Healing by urologist James Balch, M.D., and his wife, Phyllis A. Balch, “C.N.C.” The book’s jacket describes Dr. Balch as a urologist who “has helped patients to assume a portion of responsibility for their own well-being” and Mrs. Balch as a “certified nutrition consultant” who works in her husband’s prac- tice and has established a health-food store. Her “C.N.C.” designation was issued by the American Association of Nutritional Consultants, which is not a trustworthy or- ganization (see page 226). The book lists nutrients that are “essential,” “very important,” or “helpful” for more than 250 health problems. Some lists contain more than 30 items. The authors recommend daily dosages of 3000 mg or more of vitamin C for everybody (“for maintaining good health”) and higher doses (up to 30,000 mg/day “under a doctor’s supervision”) for dozens of problems.
Figure 11-4. Ads for publications that promote the products sold in health-food stores. The cartoons remind retailers that “independent” publications can convey information that would be illegal for retailers (and product labels) to provide directly. The Nutri-Books brochure depicts how books “call out” to customers. The ad for Nutrition News (a newsletter) promises that “educated” customers will buy more products and that “well informed, enthusiastic employees” will sell more products.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 223
They also recommend daily dosages of vitamin A rang- ing from 50,000 to 100,000 IU for many conditions, and 75,000 IU for “maintaining healthy eyes.” The vitamin C dosages are high enough to produce severe diarrhea; the vitamin A dosages are high enough to cause liver injury. The Balchs have also produced “prescription” books on “natural cures” and on “herbal healing.” Rodale Press, headquartered in Emmaus, Pennsylva- nia, is one of the largest publishers of books and maga- zines that promote questionable nutrition information. It was founded by J.I. Rodale (1898–1971), who was best known for his interests in “organic farming” and “health foods.” Prevention, its leading magazine, was launched in 1950 as a device to promote the products of its advertisers.7 It did this by attacking ordinary foods and recommending supplements and health foods with claims that often were ludicrous. Today the magazine emphasizes dietary improvement, appropriate exercise programs, and other health-promoting activities. Al- though much of its advice is accurate, its coverage of nutrition news has been unbalanced, it promotes dubious “alternative” methods, and it tends to encourage undue experimentation with dietary supplements. Rodale’s book division has marketed some authori- tative books, but many of their nutrition-related books contain questionable ideas. Ads for the books are more blatant than the books themselves. For example, a mailer for The Doctor’s Vitamin and Mineral Encyclopedia, by Sheldon Saul Hendler, M.D., was headlined “The World’s Most Powerful Healing Vitamins and Miner- als” and promised information on “a substance that reverses the aging process,” a “heavy-duty smart pill” that “stops the aging process and dramatically improves your memory,” and a one-a-day supplement that “could dramatically reduce your chances of breast cancer.” The pertinent passages in the book reported speculations based on preliminary or anecdotal evidence.
Pharmacists Pharmacists play an important role in the vitamin mar- ketplace. Virtually every pharmacy stocks and sells supplements that are irrationally formulated, and many stock dubious herbal and homeopathic products in ad- dition to standard drugs. Although pharmacists are generally regarded as experts, surveys suggest that many give untrustworthy advice about supplement products. In 1985, for example, reporters from Consumer Reports magazine visited 30 drugstores in Pennsylvania, Missouri, and California. The reporters complained of feeling tired or nervous and asked whether a vitamin product might help. Seventeen
were sold a vitamin product and one was sold an amino- acid preparation. Only nine of the 30 pharmacists sug- gested that a doctor be consulted.115
Barrett and Herbert7 have stated that “pharmacists have as much of an ethical duty to discourage inap- propriate use of vitamin and mineral supplements as physicians do to advise against unnecessary surgery or medical care.” Very few pharmacists do so. Dr. Merlin Nelson,116 a pharmacy educator, mailed a questionnaire asking pharmacists in Detroit to list their five most common reasons for recommending supple- ments. The most common responses included stress, colds, and athletic activity, none of which is a valid reason to take vitamins. Nelson117 also asked pharmacists why they promote and sell food supplements to healthy individuals who don’t need them. He concluded:
The most common reason is greed. Advertising creates a demand that the pharmacist can supply and make a profit. “If I don’t sell them, they’ll just go to my competition down the street,” is a common response. Pharmacists are apparently more interested in a sale than in the patient’s welfare. . . . Rather than just recommending a multivitamin to patients concerned about obtaining enough vitamins in their diet, pharmacists should offer sound nutritional advice or provide referrals to experts in nutrition such as registered dietitians.
In recent years, many pharmacists have joined programs under which they offer private consultations that inevitably lead to product sales. In some programs, clients are falsely advised that their lifestyle or prescrip- tion drug use is “depleting” them of nutrients. Other
It’s Your Decision
Would You Buy This Book?114
The publisher’s Web site states:
The world’s greatest traditional and alternative doctors join forces at last... and their findings could extend your life by 40 happy, healthy years. Order your copy of THE WORLD’S GREATEST TREASURY OF HEALTH SECRETS and discover.. . . .
• How to turn off advancing Alzheimer’s . . . almost as easily as switching off a light.
• The eating cure for arthritis . . . . • Switch migraines off with this ingenious 3-vitamin
formula. . . . • Lose weight while you sleep without eating less or
exercising more often. . . . • And much, much more.
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programs lead to unsubstantiated dietary supplement or herbal recommendations for scores of health problems. In addition, some pharmacists are illegally making “supplement” products that they promote for the treat- ment of disease.118
Internet and Storefront Retailers Many Web sites promote nutrition misinformation. The number is impossible to count but very likely exceeds 1 million. Dr. Stephen Barrett119 advises against trusting the information on any Web site that sells vitamins or herbal products because most such sites contain blatant misinformation and those that are relatively accurate fail to disclose when not to buy their products. Advice from health-food–store retailers is another important factor in the supplement marketplace. No special knowledge or training is required to become a salesperson. Personnel in these stores typically obtain information by reading books and magazines that pro- mote supplement products for the treatment of virtually
all health problems. Retailers also get information from manufacturers and can attend seminars at trade shows sponsored by industry groups and trade magazines.120 Barrett and Herbert7 characterized health-food stores as “centers of misinformation.” Although storekeepers cannot legally “diagnose” or “prescribe,” they commonly do both. Barrett122 has tabulated reports of 18 investigations that involved hundreds of retailers who were asked for advice by telephone or in person. The vast majority gave advice that was inappropriate, illegal, or both. The largest such study was conducted in 1993 by FDA agents who posed as customers at stores throughout the United States. The investigators asked: (a) “What do you sell to help high blood pressure?” (b) “Do you have anything to help fight infection or help my immune system?” and/ or (c) “Do you have anything that works on cancer?” Of 129 inquiries, 120 resulted in recommendations for products. In 23 cases the retailer looked up the answer in Prescription for Nutritional Healing or advised the agent to refer to or purchase the book.94
The Personal Glimpse Box summarizes the find- ings of a recent government investigation of storefront and Internet retailers. The Historical Perspective Box describes questionable marketing practices of the largest health food store chain.
Chiropractors More than 50 companies market supplements through chiropractic offices, where they typically are sold for at least twice their wholesale cost. Many of these products are intended for the treatment of disease, even though they are unproven and lack FDA approval for this use. Since it is illegal to place an unproven claim on a product label, product information is communicated separately through literature distributed at chiropractic meetings, company-sponsored seminars, and by mail.123
The percentage of chiropractors engaged in unscien- tific nutrition practices is unknown, but several studies suggest that it is substantial. A survey published in 2001 found that 81% of 74 chiropractors who responded said they incorporated nutritional counseling, literature, or supplementation into their practice. When asked what methods they used to assess their patients’ nutrition needs, 27% said hair analysis, 39% said applied kinesiol- ogy, and 46% said “subluxation” pattern. About half said they use nutrient combinations to treat specific diseases, a finding that the study’s authors called “somewhat alarming.”124 Athough this study was small, it dovetails neatly with data from 2574 full-time chiropractors who responded to a 2003 National Board of Chiropractic
Personal Glimpse
GAO Sting In 2010, the Government Accountability Office (GAO)121 investigated a nonrepresentative selection of 22 storefront and mail-order retailers of herbal products. Posing as elderly consumers, GAO investigators asked sales staff (by phone and in person) at each retailer a series of questions regarding herbal dietary supple- ments. GAO also reviewed written marketing language used on approximately 30 retail Web sites. Claims were evaluated against recognized scientific research. The most egregious practices included suspect marketing claims that a product could prevent or cured serious diseases, such as cancer and cardiovascular disease. Other products were claimed to mitigate age- related medical conditions, such as Alzheimer’s disease and diverticular disorder. The investigators also found claims that followed FDA’s labeling regulations and guidelines, but could still be considered deceptive or questionable and provided consumers with inaccurate information. In addition, while conducting in-person and telephone conversations with dietary supplements sellers, the investigators, posing as elderly consumers, were given potentially harmful medical advice by sales staff, including that they could take supplements. The investigators also tested 40 herbal products and found trace amounts of at least one potentially hazard- ous contaminant in 37 of them, though none contained amounts considered to pose an acute toxicity hazard.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 225
Examiners125 survey about their practices during the previous 2 years. About 89% said they did “nutritional counseling, therapy, or supplementation” and 37.6% said they used applied kinesiology.
“Nutrition Consultants” and “Counselors” Chapter 10 describes the training of dietitians and other nutrition professionals at accredited schools. During the past 30 years several nonaccredited correspondence
GNC’s Marketing
General Nutrition Companies (GNC) operates the world’s largest chain of health food stores. It has more than 4,800 retail locations throughout the United States (including more than 1000 franchise and 1200 Rite Aid store-within-a- store locations) and franchise operations in 48 international markets. During 2009 its U.S. retail sales totaled about $1.2 billion. GNC has been the object of more than 25 state and federal enforcement actions.126 The most important began in 1984, when the company, three of its officers, and two of its store managers were charged with criminal violations of the Federal Food, Drug, and Cosmetic Act. The indictment accused them of conspiring to promote and sell an evening primrose oil product with claims that it is effective against high blood pressure, arthritis, multiple sclerosis, and other diseases. The product had been promoted with newspaper and magazine articles, radio talk show discussions, flyers, and claims made by salespersons to customers. Although the company termed the product a “food supplement,” the promotional claims made it a “drug” under federal law. This meant that it could not be legally marketed without FDA approval (which it lacked). In 1986 General Nutrition pleaded guilty to four counts of misbranding a drug, and its former president and a vice president pleaded guilty to one count. The company agreed to pay $10,000 to the government as reimbursement for costs of prosecution, and the former president was fined $1000. Settlement of this case climaxed a series of federal enforcement actions against General Nutrition. In 1985 the company had signed consent agreements with the U.S. Postal Service to stop making unsubstantiated claims for 14 of its products sold by mail. In 1986 an FTC adminis- trative law judge ruled that ads for another product were deliberately misleading, and he concluded that “General Nutrition’s unconscionable, false, and misleading advertis- ing found in this case is not an isolated incident but part of a continuing pattern.” In 1988 the FTC charges were settled by a consent agreement in which the company agreed to donate $200,000 each to the American Heart Associa- tion, American Cancer Society, and American Diabetes Association for nutrition research. The agreement also prohibited the company from making any future claim for any company-produced product that cannot be substanti- ated by scientific evidence.
In 1989 eosinophilia-myalgia syndrome (EMS) broke out among users of supplements containing the amino acid l-tryptophan Previously rare, EMS is characterized by severe muscle and joint pain, weakness, swelling of the arms and legs, fever, skin rash, and an increase of eosinophils (certain white blood cells) in the blood. At least 38 people died and more than 5000 became ill, many of whom became permanently disabled. When the link between EMS and l-tryptophan became apparent, the FDA quickly banned its sale, and more than 2000 victims (or their survivors) sued the sellers, which had included GNC. During a deposition,127 GNC’s board chairman was asked whether his company was morally obliged to test whether the products it sold were safe and effective for their intended uses:
Q. Don’t you think that GNC, before it sells pills for people to take, ought to . . . determine whether there is in fact some benefit in people taking those pills?. . .
A. No . . . we should not. We are not compelled to do that. Q. So far as you’re concerned. . . it’s perfectly all right for GNC
to sell people pills to take even if those pills have no benefit whatsoever? . . .
A. That’s not what I said. . . . The benefit to them is from their perception . . . .
Q. So in other words, it’s OK for GNC to sell pills for people to take them into their bodies . . . as long as some customer is under the belief or perception that they’re going to get some benefit? . . .
A. I’m telling you that it’s up to the individual. . . . They make the decision how they want to supplement their diet. . . .
Q. Would you agree that your company has an obligation to test . . . products before they’re sold for human consumption to determine whether they are in fact beneficial?
A. No more than a grocery store does foods coming in. We’re a retailer.
In 1993 GNC agreed to pay a penalty of $2.4 million to settle FTC charges that it had made unsubstantiated claims for 42 more products. These included 15 alleged weight-control products, 18 alleged “ergogenic aids,” five bogus hair-loss preventers, two alleged antifatigue prod- ucts, and two purported disease-related products. This case appears to have persuaded GNC to stop making blatantly false claims in its ads. But neither it nor other supplement sellers appear to care much about whether the pills and potions they sell actually work.
Historical Perspective
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schools have offered B.S., M.S., and Ph.D. “degrees” in nutrition whose holders represent themselves as quali- fied to give professional advice. Such schools almost always advocate unscientific concepts. Moreover, it is not possible to learn to properly care for patients without lengthy supervised experience with patients, which most nonaccredited schools do not offer. The most notorious nonaccredited schools have been Donsbach University and Clayton College of Natural Health. Donsbach University began operating in the late 1970s. Its founder and president, Kurt W. Donsbach, is discussed later in this chapter. The school was “au- thorized” to operate by the State of California, which meant only that it had assets of at least $50,000 and had informed the authorizing agency of its programs. Most “textbooks” required for the school’s basic curriculum were books written for the general public by promoters of dubious nutrition practices. A typical degree program took less than 1 year to complete. Graduates typically refer to themselves as “nutrition consultants,” a term also used by some reputable nutritionists. The school ceased operations in 1987, but some of its “graduates” are still in practice. Clayton College of Natural Health (CCNH) claimed to have had more than 25,000 graduates since 1980. Most of its “degrees” were in nutrition or naturopathy. Clayton stated that it was accredited by the American Associa- tion of Drugless Practitioners and the American Natu- ropathic Medical Accreditation Board. However, these are not recognized by the U.S. Secretary of Education, which means that their “accreditation” is meaningless. Although most CCNH programs took at least several months to complete, Barrett128 has noted that one student received B.S., M.S., and Ph.D. diplomas dated on the same day. Clayton closed in 2010, largely because of a state rule that required accreditation as a condition for license renewal. The Institute for Integrative Nutrition (IIN), head- quartered in New York City, refers to itself as “the world’s largest nutrition school.” Its primary offering is an 8-month part-time course whose graduates receive a “health counselor” certificate and eligibility for “board certification” by the American Association of Drugless Healers. IIN’s program focuses on foods and eating choices but contains little about the sciences of biochem- istry or physiology on which dietary strategies should be based. The goal appears to be to enable students to find what dietary and activity strategies work best for them and then do the same for clients. The catalog states that IIN teaches more than 100 different dietary therapies and “analyzes the pros and cons of them all.”
Barrett129 has noted that IIN’s approach might inspire some people to improve their diet by moving closer to the Dietary Guidelines for Americans. However, they may also absorb misconceptions about diet, health, and disease that will ultimately harm them. “Nutrition consultants” and “counselors” who want additional “credentials” can obtain them from various groups that issue membership certificates suitable for framing. Some also hold seminars, publish a directory, offer “certification,” engage in political action, offer in- surance programs, and publish periodicals. The two most active have been the American Association of Nutritional Consultants (AANC) and the National Association of Certified Natural Health Professionals (NACNHP). During the 1980s, the AANC offered professional membership certificates and “certification” as a “Certi- fied Nutritional Consultant” (CNC). Its only professional membership requirement was a $50 fee. Several investi- gators were able to enroll household pets (Figure 11-5). The CNC designation required payment of a $250 fee and passage of an open book exam based on books that promoted unscientific concepts. The NACNHP, which arose after AANC declined, holds frequent seminars and has certified thousands of its members who may place CNHP after their name. The AANC appears to have no current organizational activity, but memberships and certificates are still offered through a site registered to the NACHNP’s founder. Barrett has noted: “These groups have one potentially valuable aspect: Member- ship in them is a reliable sign of someone not to consult for advice.”130
Figure 11-5. This attractive “credential,” printed on imitation parchment and decorated with a gold seal and red ribbon, was issued to a pet hamster whose owner merely submitted the rodent’s name and address and a check for $50.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 227
The Clinical Nutrition Certification Board (CNCB), which offers a Certified Clinical Nutritionist (CCN) credential, was founded in 1991 to provide credential- ing to nutrition professionals who might not be eligible to become registered dietitians or be certified by the American Board of Nutrition. Both CNCB and its sponsoring organization (the International and American Associations of Clinical Nutrition) include promoters of highly dubious practices among their leaders. Although some members are qualified and practice appropriately, CNCB’s required clinical nutrition course promotes the use of homeopathy, dubious laboratory tests, detoxifi- cation, herbology, homeopathy, and alternative cancer therapies. In response to the flaunting of dubious credentials, dietitians have gained passage of laws to regulate nutri- tionists in most states and the District of Columbia.131 Some make it illegal for unqualified persons to call themselves dietitians or nutritionists, while others define nutrition practice and who is eligible to practice. In states that regulate nutrition practice, health-food retailers are still permitted to give limited advice about diet and the use of their products but are not permitted to do nutrition assessment or counseling.
promotioNal orgaNizatioNs Many organizations promote unscientific concepts of nutrition that can cause public confusion and lead in- dividuals to make unwise purchases or jeopardize their health. Some of the organizations have respectable- or scientific-sounding names, and some even engage in a few activities helpful to the general public. For these reasons, they deserve close scrutiny by consumers. National Health Federation The National Health Federation (NHF) is a membership organization headquartered in Monrovia, California. NHF’s primary theme is “freedom of choice” in health matters, but it has little interest in scientifically recog- nized methods. Its magazine, Health Freedom News, promotes dubious treatments and criticizes proven public health measures such as pasteurization, immunization, water fluoridation, and food irradiation. Speakers at NHF conventions espouse worthless cancer treatments and a wide range of other dubious practices. Government enforcement actions have been taken against at least 20 of NHF’s past or present leaders (or their companies) who engaged in illegal health-related activities.14
NHF is active in the political arena. It presents tes- timony to regulatory agencies and supports legislation aimed at minimizing government interference with the
health-food industry. Its letter-writing campaigns, often voluminous, typically include charges of persecution, discrimination, and conspiracy. NHF was founded in 1955 by Fred J. Hart, president of the Electronic Medical Foundation. In 1954 a U.S. district court ordered Hart and the Foundation to stop distributing 13 electronic devices with false claims that they could diagnose and treat hundreds of diseases and conditions. Royal S. Lee, a nonpracticing dentist who died in 1967, helped Hart found NHF and served on its board of governors. In 1962 he and the vitamin company that he owned were convicted of misbranding 115 “food supplement” products by making false claims on their labels for the treatment of more than 500 diseases and conditions. In 1973 a prominent FDA official described Lee as “probably the largest publisher of unreliable and false information in the world.”14 The products contained various combinations of vitamins, minerals, herbs, and dehydrated animal organs. The company, Standard Pro- cess Laboratories, still markets many of them, primarily through chiropractors. Although unsubstantiated health claims no longer appear on the product labels, such claims are made at seminars sponsored by “independent” distributors of the products. Kurt Donsbach, who chaired NHF’s board of governors from 1975 through 1989, obtained a chiropractic degree but practiced chiropractic only briefly. During the 1960s, he worked for Lee as a “research associate.” In 1970, while Donsbach operated a health-food store, agents of the Fraud Division of the California Bureau of Food and Drug observed him represent that vitamins, minerals, and herbal teas were effective against cancer, emphysema, and other conditions. Charged with practicing medicine without a license, he pleaded guilty and paid a small fine. His subsequent health-related ventures have included books, magazines, newsletters, vitamin companies, nonaccredited correspondence schools, syndicated radio and television programs, and a Mexican clinic (Hospital Santa Monica) that offered dubious treatments for cancer and other serious diseases. In 1996, he was indicted and pleaded guilty to smuggling unapproved drugs into the United States and not paying income tax on the money he made for selling them. In 2010, Donsbach pleaded guilty to 13 more federal felony charges: five counts of practicing medicine without a license, five counts of selling/distributing misbranded drugs, and one count each of of attempted grand theft, grand theft, and being a felon in possession of a firearm. He was fined $60,000 and ordered to serve 1 year in prison followed by 10 years of probation, during which he is prohibited from representing himself as a health practitioner. 132
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Citizens for Health Citizens for Health (CFH) was formed in 1992 in response to concerns about FDA regulation of supple- ment products. It grew rapidly and acquired thousands of members, with state and local chapters throughout the country. Like NHF, CFH campaigned actively for the 1994 Dietary Supplement Health and Education Act, the purpose of which was to weaken government regulation of food supplements. These groups have also promoted state and federal legislation intended to block government interference with “alternative” practitioners (see Chapter 8).
American Botanical Council The American Botanical Council is a nonprofit member- ship organization whose primary activity is public edu- cation. It publishes books, monographs, and a quarterly magazine called Herbalgram. The quality of the informa- tion it distributes is variable: most is accurate, but some is overly promotional. It offers individual memberships but most of its financial support appears to come from herbal product manufacturers and distributors.
Trade Organizations Health-food retailers have regional and national trade or- ganizations that provide political, legal, and educational support. The largest is the Natural Products Association (NPA), which represents more than 10,000 retailers, pro- ducers, wholesalers, and distributors of natural products. Its activities include annual conventions, a newsletter, and campaigns to minimize governmental regulation of the industry. Major manufacturers and distributors of vitamins and minerals also are represented by the Council for Responsible Nutrition. During 1991 the health-food industry became alarmed that proposed new labeling rules would greatly reduce the number of products it could market and that proposed laws to strengthen federal enforcement agen- cies would weaken the industry still further. Early in 1992 the Nutritional Health Alliance (NHA) was formed to enable manufacturers, suppliers, distributors, retail- ers, consumers, and other supplement industry allies to coordinate their efforts to protect the industry. NHA quickly launched a campaign that generated over 1 mil- lion protest letters to Congress and spearheaded legisla- tion intended to weaken the FDA. Citizens for Health and the NHA (then called the National Nutritional Foods Association) also played major roles in the campaign, which Dr. Barrett characterized as a “vitamin war.”133 The resultant Dietary Supplement Health and Education Act of 1994 is described in Chapter 25.
promiNeNt iNdiVidual promoters
Many individuals have developed and promoted food fads and other dubious nutrition practices. Each of the following persons has written several books and achieved notoriety during the recent past. Andrew Weil, M.D., is described on the covers of his best-selling books as “the guru of alternative medicine,” “one of the most skilled, articulate, and important lead- ers in the field of health and healing,” and “a pioneer in the medicine of the future.” His advice is a mixture of sense and nonsense. The sensible part includes standard advice about diet and exercise. The nonsense includes such ideas as “improper breathing is a common cause of ill health” and the recommendation that following surgery, patients should get massive intravenous doses of vitamin C. He tends to prefer the use of “natural remedies” rather than conventional medicines. He has published nothing in scientific journals to objectively document his personal experiences with allegedly cured
√ Consumer Tip
Suggestions for Consumers The following suggestions should help consumers make healthy and economically sound decisions regarding nutrition: • It is virtually impossible for laypersons to sort out
nutrition sense from nonsense on a claim-by-claim basis. The more practical approach is to examine the overall philosophy of the individual, organiza- tion, or publication making the claim.
• Be wary of anyone who promotes the fads and fallacies identified in this chapter. Use the reliable sources of information identified in Chapter 2 and the Appendix of this book.
• Ignore the information provided by Web sites that market dietary supplements and herbs.
• Avoid practitioners who prescribe vitamin supple- ments for everyone or who sell them in connection with their practice.
• Be wary of any product promoted for a particular purpose that is not printed on its label. Federal laws require that health products be truthfully labeled and carry adequate directions for use. It is extremely unlikely that a product will do anything that is not claimed on its label.
• Knowledge of the basic principles of nutrition as outlined in Chapter 10 should enable you to make wise food selections.
Chapter Eleven Nutrition Fads, Fallacies, and Scams 229
patients or to substantiate his claims that the nonstandard remedies he advocates are effective.134 The “Ask Dr. Weil” Web site contains an interactive “Vitamin Advisor” questionnaire that leads to a “personalized formula” of recommended dietary supplements—typically 6 to 10 products per person that would cost about $2 per day. The explanations for these recommendations have been poorly reasoned. Joseph Mercola, D.O., who practices in Schaumburg, Illinois, operates one of the Internet’s largest and busi- est health information sites (www.mercola.com). Mer- cola states that millions of people visit his site daily to search from over 300,000 pages of information and that his e-mail newsletter has over 1.5 million subscribers. Many of his articles make unsubstantiated claims and clash with those of leading medical and public health organizations. For example, he opposes immunization and fluoridation, claims that amalgam fillings are toxic, and makes many unsubstantiated recommendations for dietary supplements. Much of his support comes from chiropractors who promote his newsletter from their Web sites. In 2005 and 2006, the FDA ordered him to stop making illegal claims for several products sold through his Web site. One was for Living Fuel Rx, a powdered multi-ingredient supplement that he said offered an “exceptional countermeasure” against cancer, cardio- vascular disease, diabetes, and autoimmune diseases. In 2011, the FDA ordered him to stop suggesting that thermography is more useful than mammography for detecting breast cancer.135
Earl Mindell, who co-founded a chain of health food stores, has a bachelor’s degree in pharmacy from the University of North Dakota and “Ph.D.s” in nutrition from two nonaccredited schools.7,136 His books include Earl Mindell’s Vitamin Bible, Earl Mindell’s Vitamin Bible for Kids, Unsafe at Any Meal, Earl Mindell’s Herb Bible, and Earl Mindell’s Soy Miracle. The Vitamin Bible recommends self-treatment with supplements for more than 50 health problems. The book also promotes sub- stances that Mindell calls “vitamins” B10, B11, B13, B15, B17, T, and U. There is no scientific evidence that any of these substances are vitamins (essential to humans) or that supplements of any of them are beneficial. Now retired from active management of his stores, Mindell spends much of his time writing and lecturing. In recent years, he has helped to market “Soy Miracle” products with a multilevel company called FreeLife International. FreeLife flyers call Mindell “America’s #1 Nutrition Expert.” Robert O. Young, author of The pH Miracle, mar- kets himself as “Robert O. Young, M.S., D.Sc., Ph.D.”
and claims to be “widely recognized as one of the top research scientists in the world.” However, all of his “degrees” came from nonaccredited Clayton College of Natural Health, and the Medline database lists no articles with him as author.137
Young claims that (a) “acidification and overgrowth of negative microforms in the body are the root cause of every symptom, illness and disease” and (b) health depends primarily on proper balance between an alkaline and acid environment that can be optimized by dietary modification and taking supplements. However, homeo- static mechanisms keep the acidity of the blood stream within a narrow range, and no one has ever demonstrated that trying to change it produces a general health benefit or can cure a wide range of diseases.138 Young markets supplement products and uses live cell analysis to advise people what they need. Press reports indicate that in 2003, after two brushes with the law in Utah, he moved to California because he thought the legal climate there was more tolerant for “dietary researchers” such as himself.139
summary
Most Americans probably are harmed to some degree by nutrition fads and fallacies. Promoters of nutrition quackery are well-organized and skilled at arousing and exploiting fears and false hopes. Their most persuasive sales pitch is that everyone should take supplements to be sure of getting enough vitamins and minerals. How- ever, it is more sensible for individuals worried about this to keep a food diary for several days and have a physician or registered dietitian determine whether any problem exists. Supplements and “health foods” have been recom- mended for virtually every ailment. However, there is
It’s Your Decision
1. You have suffered from severe tension at work and at home. You have read an advertisement for “stress vitamins.” What action should you take to reach an intelligent decision about using such vitamins?
2. You visit a health-food store to buy some rice flour. While you are browsing, a clerk engages you in con- versation, learns that you are troubled by occasional headaches, and suggests several herbal products to help you. The clerk also learns that your mother has arthritis and suggests several products for her. What should you do about these recommendations?
Part Three Nutrition and Fitness230
little or no scientific evidence to support such recom- mendations. Megadoses of vitamins and minerals have few legitimate uses and should never be taken without competent medical advice. Anyone who sells supple- ments or recommends them for everyone should be ignored.
reFereNces
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7. Barrett S, Herbert V. The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods. Amherst, N.Y., 1994, Prometheus Books.
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59. Mirkin G. Can bee pollen benefit health? JAMA 262:1854, 1989. 60. Advice on limiting intake of bone meal. FDA Drug Bulletin
12:5–6, 1982. 61. Nielsen FH. Facts and fallacies about boron. Nutrition Today
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68. Barrett S. Glucosamine and chondroitin for arthritis: Benefit is unlikely. Quackwatch Web site, July 22, 2010.
69. Herxheimer A, Petrie KJ. Melatonin for the prevention and treatment of jet lag. Cochrane Database of Systematic Reviews 2002(2):CD001520.
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71. Barrett S. Algae: False claims and hype. Quackwatch Web site, Jan 14, 2007.
72. Mossad SB and others. Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study. Archives of Internal Medicine 125:81–88, 1996.
73. Zinc for the common cold. The Medical Letter 39:9–10, 1997. 74. Tips for the savvy supplement user: Making informed decisions
and evaluating information. FDA Web site, Jan 2002.
75. Barrett B and others. Echinacea for treating the common cold. A randomized trial. Annals of Internal Medicine 153:769–777, 2010.
76. Shekelle P and others. Ephedra and ephedrine for weight loss and athletic performance enhancement: Clinical efficacy and side effects. AHRQ Publication No. 03-E022. Rockville, Md., 2003, Agency for Healthcare Research and Quality.
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78. Snitz BE and others. Ginkgo biloba for preventing cognitive decline in older adults. JAMA 302:2663-2670, 2009.
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80. Rambaldi A and others. Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases. Cochrane Database of Systematic Reviews 2005(2):CD003620.
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82. Tacklind J and others. Serenoa repens for benign pros- tatic hyperplasia. Cochrane Database of Systematic Reviews 2009(2):CD001423.
83. Shelton RC and others. Effectiveness of St. John’s wort in major depression: A randomized, controlled trial. JAMA 285:1978–1986, 2001.
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85. Draves AH, Walker SE. Analysis of the hypericin and pseudo- hypericin content of commercially available St. John’s wort preparations. Canadian Journal of Clinical Pharmacology 10:114-118, 2003.
86. United States Pharmacopeia. Valerian (Valeriana officinalis). Information Monograph. Rockville, Md., 1998, United States Pharmacopeia.
87. Barnes J and others. Herbal Medicines, 3rd Edition. London, 2007, Pharmaceutical Press.
88. Barrett S. The herbal minefield. Quackwatch Web site, March 16, 2004.
89. Gurley BJ and others. Content versus label claims in ephedra- containing dietary supplements. American Journal of Health- System Pharmacists 57:963–969, 2000.
90. Jellin JM, ed. Natural Medicines Comprehensive Database. Stockton, Calif., 2007, Therapeutic Research Faculty.
91. Garrard S and others. Variations in product choices of frequently purchased herbs: Caveat emptor. Archives of Internal Medicine 163:2290–2295, 2003.
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93. Toxic plant products sold in health food stores. The Medical Letter, April 6, 1979.
94. Unsubstantiated Claims and Documented Health Hazards in the Dietary Supplement Marketplace. Rockville, Md., 1993, U.S. Food and Drug Administration.
95. Dangerous supplements: Still at large. Consumer Reports 69(5):12–17, 2004.
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97. Saper S and others. Heavy metal content of ayurvedic herbal medicine products. JAMA 292:2868–2873, 2004.
98. Deutsch RM. The New Nuts Among the Berries. Palo Alto, Calif., 1977, Bull Publishing.
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99. Barrett S. Adelle Davis’s legacy. Quackwatch Web site, March 27, 1999.
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102. Raso J. A Kushi seminar for professionals. Nutrition Forum 7:17–21, 1990.
103. Lindner L. The new improved macrobiotic diet. American Health 7(4):71–86, 1988.
104. Associated Press. Aveline Kushi, 78, leading proponent of macrobiotic diet. Newsday, July 6, 2001.
105. Hambidge KM. Hair analysis: Worthless for vitamins, limited for minerals. American Journal of Clinical Nutrition 36:943– 949, 1982.
106. Barrett S. Commercial hair analysis: Science or scam? JAMA 254:1041–1045, 1985.
107. Seidel S and others. Assessment of commercial laboratories performing hair mineral analysis. JAMA 285:67–72, 2001.
108. Kenny JJ, Clemens R, Forsythe KD. Applied kinesiology un- reliable for assessing nutrient status. Journal of the American Dietetic Association 88:698–704, 1988.
109. Lowell J. Live cell analysis: High-tech hokum. Nutrition Forum 3:81–85, 1986.
110. Barrett S. Be wary of bogus vitamin questionnaires. Priorities, pp 37–40, Spring 1990.
111. Roth JA. Health Purifiers and Their Enemies. New York, 1977, Neal Watson Academic Publications (Prodist).
112. Temple NJ. The marketing of dietary supplements in North America: The emperor is (almost) naked. Journal of Alternative and Complementary Medicine 16:803–806, 2010.
113. Building your nutritional food business with books and maga- zines—a merchandising manual. Denver, 1982, Nutri-Books.
114. Quill AJ. The World’s Greatest Treasury of Health Secrets: Comments on the 2006 book and infomercial. Infomercial Watch Web site, Feb 2, 2007.
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117. Nelson MV. Promotion and selling of unnecessary food supple- ments: Quackery or ethical pharmacy practice? American Pharmacy NS28(10):34–36, 1988.
118. Barrett S. Unethical and ignorant behavior by pharmacists. Quackwatch Web site, July 19, 2011.
119. Barrett S. How to spot a “quacky” Web site. Quackwatch Web site, Sept 6, 2006.
120. Fanning O. “Training” for health food retailers. Nutrition Forum 3:33–38, 1986.
121. Kutz D. Herbal dietary supplements: Examples of deceptive and questionable marketing practices and potentially dangerous advice. Report No. GAO-10-662T, May 26, 2010.
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123. Barrett S. Chiropractors and nutrition: The supplement under- ground. Nutrition Forum 9:25–28, 1992.
124. Smith DL, Spillman DM. A survey of chiropractors’ use of nutrition in private practice. Journal of Chiropractic Humani- ties, Vol 10, No.1, Nov 2001.
125. Christensen MG and others. Job Analysis of Chiropractic. Gree- ley, Colo, 2005, National Board of Chiropractic Examiners.
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127. Horn JD. Deposition re l-tryptophan litigation. MDL docket number 865, U.S. District Court, District of South Carolina, Columbia Division, Aug 11, 1992.
128. Barrett S. Clayton College of Natural Health: Be wary of the school and its graduates. Quackwatch Web site, July 23, 2011.
129. Barrett S. A skeptical look at the Institute for Integrative Nutri- tion. Quackwatch Web site, Jan 9, 2010.
130. Barrett S. The American Association of Nutritional Consultants: Who and what does it represent? Quackwatch Web site, Nov 27, 2007.
131. State licensure agency list. ADA Commission on Dietetic Registration Web site, accessed Nov 18, 2010.
132. Barrett S. The shady activities of Kurt Donsbach. Quackwatch Web site, April 11, 2011.
133. Barrett S. Proposed labeling rules stir controversy. Nutrition Forum 9:9–14, 1992.
134. Relman A. A Trip to Stonesville. The New Republic, Dec 14, 1998.
135. Barrett S. FDA orders Dr. Joseph Mercola to stop illegal claims. Quackwatch Web site, May 26, 2011.
136. Lowell JA. An irreverent look at the Vitamin Bible and its author. Nutrition Forum 3:46–47, 1986.
137. Barrett S. A close look at “Dr.” Robert Young’s theories and credentials. Quackwatch Web site, Feb 24, 2010.
138. Mirkin G. Acid/alkaline theory of disease is nonsense. Quackwatch Web site, Jan 11, 2009.
139. Jenkins L. Naturopathic technique stirring bad blood. San Diego Tribune, April 11, 2005.
Weight Control
Americans brought up in a society full of technological miracles are constantly searching for the easy way out. In desperation, they are willing to try anything offered to them, wasting money, time and sometimes their own lives. GeorGe L. BLackBurn, M.D., Ph.D. konstantin PavLou, sc.D.1
Diets usually leave a person aggravated, discouraged, and the same size.
aMy Lanou, Ph.D.2
Q. Can a diet pill really cause people to lose fat while they sleep? A. If it worked you would be reading about it in the headlines of every newspaper in the country. ann LanDers
© medical economics, 1992
“It doesn’t look that scary to me, either. But my Mom won’t even go near it.”
Chapter Twelve
Part Three Nutrition and Fitness234
In 2010 Americans spent about $61 billion for products and services they hoped would en- able them to control their weight.3 Much of this
money was wasted. The following observation, made in 1972 in the AMA’s Today’s Health4 magazine, is still appropriate today:
They will attend reducing clinics and join reducing programs. They will visit doctors who will write weight-reducing pre- scriptions for them and inject them with hormones. They will enter hospitals for fat-removing operations. They will get themselves hypnotized, and psychoanalyzed individually and in groups. They will purchase books and pamphlets extolling the virtues of high-calorie diets; low-calorie diets; high fat, carbohydrate and/or protein diets; low-fat, carbohydrate and/ or protein diets; grapefruit diets; water diets; drinking men’s diets; organic food diets; and sex-instead-of-supper diets. They will gulp down diet pills, blow on diet soups, chomp on diet cookies and chew on diet gum. Most of the time, for a variety of legitimate reasons, they will emerge in much the same condition as when they began: fat. And much of the time, for a variety of illegitimate reasons, they will also emerge defrauded.
This chapter describes the basic principles of weight control and the various types of products, procedures, and professional services used in the attempt to achieve it. Included in this discussion are diets, pills, special foods, and gadgets, as well as medical, surgical, and psychologic procedures, clinics, and self-help groups. For additional information on exercise, exercise devices, and “spot-reducers,” see Chapter 13.
BasiC ConCepts
The words obese and overweight are often used in- terchangeably. Strictly speaking, obesity refers to an excess accumulation of fatty tissue in the body, whereas overweight refers to a weight greater than that listed in
an established height-weight table (Table 12-1). These terms are not mutually exclusive because obese persons are also overweight. The National Institutes of Health (NIH) guidelines use body mass index (BMI) to classify weight status. The BMI is the person’s weight in kilograms divided by the square of the person’s height in meters. It can also be calculated by multiplying one’s weight in pounds by 700, dividing the result by one’s height in inches, and dividing by height again. The guidelines classify adults 18 and older into six groups: underweight (BMI less than 18.5), normal (18.5–24.9), overweight (25.0–29.9), Class I obesity (30.0–34.9), Class II obesity (35.0–39.9), and Class III (extreme) obesity (40 or more). People with a BMI of 40 or more are commonly referred to as morbidly obese. Table 12-2 illustrates representative BMI values. BMI calculators are available on many Web sites, includ- ing www.nhlbisupport.com/bmi/bminojs.htm. The causes of obesity are multiple and complex; they include glandular abnormalities (rarely), heredity, improper eating habits, insufficient physical activity, and psychosocial problems. Americans generally are getting heavier. Based on data from the 2007–2008 National Health and Nutrition Examination Survey (NHANES), experts have estimated that 73% of adults ages 20 to 74 are overweight or obese, up from about 47% in 1976–1980, 56% in 1988–1994, and 65% in 1999–2002.5 During the same period, the prevalence of overweight also rose from 5% to 10% in children ages 2–5, 7% to 20% among children ages 6–11, and from 5% to 18% among adolescents ages 12–19.6
Most people who are overweight are overfat (obese). However, some individuals—particularly muscular young men—can exceed the listed weight without being overfat. Thus it is more precise to use the term overfat when referring to someone whose weight is too high because of excessive body-fat content.
• The most sensible weight-loss plans aim for a steady reduction of about 1 pound a week.
• Mail-order products claimed to produce rapid or permanent weight loss are scams.
• Fad or “crash” diets rarely have a permanent beneficial effect.
• To lose weight safely and keep it off, people must make long-term changes in their eating and exercise habits.
• Commercial weight-loss programs are expensive and have demonstrated little evidence of long-term effectiveness.
• Many people concerned about their weight would probably do better to focus on exercise and healthful eating rather than on counting calories.
Keep these points in Mind as You studY this Chapter
Key Concepts
Chapter Twelve Weight Control 235
Body fat can be estimated with fair accuracy by measuring the thickness of various skin folds with one’s fingers or a special skin caliper. More accurate methods include underwater weighing, ultrasound, electromag- netic methods, bioelectrical impedance, CT scanning, neutron activation, and nuclear magnetic imaging, but these are expensive and used mainly for research pur- poses. A rough indication of excessive body fat can be obtained by pinching the flesh on the back of the upper arm, midway between the shoulder and the elbow. Men who can pinch 1 inch or more and women who can pinch more than 11/4 inches are probably overfat. Perhaps the most practical method is to remove one’s clothes and look into a full-length mirror. The Desirable Weight Table (see Historical Perspec- tive box) offers yet another assessment tool.
Health Risks of Obesity Tens of millions of Americans have too much body fat. Small degrees of overfat are not harmful, but being 20% overfat is clearly a health hazard.7,8 The life expectancy of Americans has risen steadily during the past two cen- turies, but Olshansky9 and others have expressed concern that this trend will soon come to an end. The most serious problem associated with being overfat is high blood pressure, but there are also consid- erably increased risks of sickness or death from diabetes; gallstones; liver, kidney, heart, and blood vessel diseases; osteoarthritis; and other problems. Overweight is also a contributing cause of sleep apnea, a common disorder in which the affected individual has pauses in breathing during sleep.10
The health significance of body fat can be esti- mated by using the BMI. Overweight carries a slightly increased risk for weight-related health problems, but obesity (BMI of 30 or more) entails serious health risks.11
Obese men tend to accumulate abdominal fat, whereas women tend to accumulate fat on their hips and thighs. A waist-to-hip ratio (WHR) greater than 1 indicates a high risk of adverse health consequences. WHR is determined by dividing the circumference of the waist by the circumference of hips. The waist is measured at the level of the navel (belly button), and the hips are measured at the area of maximum protrusion of the buttocks. A man with 35-inch hips and a 42-inch waist, for example, would have a WHR of 1.2. With respect to health risks, the location may be more important than the total amount of body fat. In men a high WHR is associated with elevated blood- cholesterol levels and increased risk of coronary artery
taBle 12-1. desiraBle Weights, ages 25 and older
5’–2” 112–120 118–129 126–141 5’–3” 115–123 121–133 129–144 5’–4” 118–126 124–136 132–148 5’–5” 121–129 127–139 135–152 5’–6” 124–133 130–143 138–156 5’–7” 128–137 134–147 142–161 5’–8” 132–141 138–152 147–166 5’–9” 136–145 142–156 151–170 5’–10” 140–150 146–160 155–174 5’–11” 144–154 150–165 159–179 6’–0” 148–158 154–170 164–184 6’–1” 152–162 158–175 168–189 6’–2” 156–167 162–180 173–194 6’–3” 160–171 167–185 178–199 6’–4” 164–175 172–190 182–204 4’–10” 92–98 96–107 104–119 4’–11” 94–101 98–110 106–122 5’–0” 96–104 101–113 109–125 5’–1” 99–107 104–116 112–128 5’–2” 102–110 107–119 115–131 5’–3” 105–113 110–122 118–134 5’–4” 108–116 113–126 121–138 5’–5” 111–119 116–130 125–142 5’–6” 114–123 120–135 129–146 5’–7” 118–127 124–139 133–150 5’–8” 122–131 128–143 137–154 5’–9” 126–135 132–147 141–158 5’–10” 130–140 136–151 145–163 5’–11” 134–144 140–155 149–168
M E N
W o M E N
Medium Frame
Large Frame
Small Frame
Height in Shoes
Weight in Pounds
Weights are obtained in indoor clothing, with men wearing shoes with 1-inch heels and women wearing shoes with two-inch heels. The data are based on weights associated with lowest death rates. For adults younger than 25, subtract 1 pound for each year under 25. An article at www.halls.md/ideal-weight/met.htm) indicates how to determine frame size and provides additional historical information.
Historical Perspective
The “Desirable Weight” Table12
The concept of the height-weight table was developed many years ago by Louis Dublin, a Metropolitan Life Insurance Company statistician. After grouping policyholders by age, height, and weight, he found that those who lived longest were the ones who maintained their weight at the average level for 25-year-olds. Because Dublin felt that there was no “ideal” weight for all individuals, he called these ranges “desirable weights.” The table below lists the “desirable weights” he proposed in 1959 for adults ages 25 and older. Some statisticians have criticized these weights because they involved only individuals who had qualified for life insurance and mainly reflected data from upper-middle-class white groups. But many authorities believed they were still the best figures relating weight to life expectancy.13
Part Three Nutrition and Fitness236
4’–10” 96 100 105 110 115 119 124 129 134 138 143 167 191 4’–11” 99 104 109 114 119 124 128 133 138 143 148 173 198 5’–0” 102 107 112 118 123 128 133 138 143 148 153 179 204 5’–1” 106 111 116 122 127 132 137 143 148 153 158 185 211 5’–2” 109 115 120 126 131 136 142 147 153 158 164 191 218 5’–3” 113 118 124 130 135 141 146 152 158 163 169 197 225 5’–4” 116 122 128 134 140 145 151 157 163 169 174 204 232 5’–5” 120 126 132 138 144 150 156 162 168 174 180 210 240 5’–6” 124 130 136 142 148 155 161 167 173 179 186 216 247 5’–7” 127 134 140 146 153 159 166 172 178 185 191 223 255 5’–8” 131 138 144 151 158 164 171 177 184 190 197 230 262 5’–9” 135 142 149 155 162 169 176 182 189 196 203 236 270 5’–10” 139 146 153 160 167 174 181 188 195 202 207 243 278 5’–11” 143 150 157 165 172 179 186 193 200 208 215 250 286 6’–0” 147 154 162 169 177 184 191 199 206 213 221 258 294 6’–1” 151 159 166 174 182 189 197 204 212 219 227 265 302 6’–2” 155 163 171 179 186 194 202 210 218 225 233 272 311 6’–3” 160 168 176 184 192 200 208 216 224 232 240 279 319 6’–4” 164 172 180 189 197 205 213 221 230 238 246 287 328
BMI: 20 21 22 23 24 25 26 27 28 29 30 35 40
BodY Mass index (BMi) Table 12–2
Height Weight (Pounds)
Find your height in the left column and move across to the column containing your weight. The bold number at the bottom of the column is your BMI (your weight in kilograms divided by the square of your height in meters).
disease, high blood pressure, and adult-onset diabetes. These problems are related more to fatty tissue located inside the abdominal cavity than to fatty tissue located just under the skin. Preventing obesity during childhood may lower the chance of obesity in adult life.14 Unfortunately, the rates of obesity among American children and adolescents are high and have been increasing steadily.6
Difficulty with “Dieting” The two basic factors involved in weight control are caloric intake and energy expenditure. To lose weight one must eat less or exercise more—but most people need to do both. There are about 3500 calories stored in 1 pound of body fat. Most moderately active people need about 15 calories per pound to maintain their weight (see Table 12-3). To lose 1 pound of fat per week, one must consume an average of 500 fewer calories per day than are metabolized. Nutritionists recommend against using diets under 1200 calories per day without medi- cal supervision. Table 12-4 shows how caloric deficit is related to the rate of weight loss.
Most people who are overfat find weight control difficult or impossible to achieve. Long-term studies of overfat individuals—done mainly in hospital clinics— have found that more than 95% of those who lost weight
approxiMate CaloriC intaKe ModeratelY aCtive people need to Maintain Weight
Table 12–3
Weight Daily Calories Needed 100 1500 110 1650 120 1800 130 1950 140 2100 150 2250 160 2400 170 2550 180 2700 190 2950 200 3000
Chapter Twelve Weight Control 237
by dieting regained it within 1 year. Dietary treatment is most likely to succeed in people who are only modestly overweight. Obese individuals tend to “burn” calories more slowly. They tend to be less active, which com- pounds the problem, because people tend to eat more when they are sedentary. They also tend to underestimate the number of calories they eat15,16 and to underreport their weight and overreport their height.17 Table 12-5 discusses common myths about weight control. The Institute of Medicine11 has defined successful dieting as a 5% reduction in initial body weight that is maintained for at least 1 year. Evidence is accumulating that heredity may be the major predisposing factor in determining how much people weigh. When people deviate from their usual weight, metabolic adjustments tend to oppose the change. Researchers have found, for example, that significant weight loss is accompanied by increased hunger and a decrease in the body’s metabolic rate.18 Bennett19 has noted that the weight-control measures are not hopeless because people’s “fat thermostat” may be reset if they consume less fat and increase their habitual level of physical activity. Some studies suggest that weight cycling (repeated weight loss through dieting followed by weight gain) may increase the risk for high blood pressure, high cho- lesterol, and gallbladder disease. However, the National Task Force on the Prevention and Treatment of Obesity20 concluded that the majority of studies published between 1966 and 1994 did not conclusively show that weight
cycling is harmful. The task force stated that signifi- cantly obese individuals should not allow concerns about hazards of weight cycling to deter them from trying to control their weight. Because “dieting” is usually unsuccessful, many experts believe that people’s emphasis should be on fit- ness (readily attainable through exercise) and control of cardiovascular risk factors (abnormal blood cholesterol levels, high blood pressure, and elevated blood sugar levels). For example, the participants in a 1992 NIH Technology Assessment Conference21 concluded:
Methods whose primary goal is short-term rapid or unsu- pervised weight loss, or that rely on such diet aids as drinks, prepackaged foods, or pharmacologic agents but do not include education in and eventual transition to a lasting program of healthful eating and activity, have never been shown to lead to long-term success. It has been fairly said that such programs fail people, not vice-versa. Recognition of this by society and individuals and a focus on approaches that can produce health benefits independently of weight loss may be the best way to improve the physical and psychological health of Americans seeking to lose weight.
The panelists also concluded: “A health paradox ex- ists in modern America. On the one hand, many people who do not need to lose weight are trying to. On the other hand, most who do need to lose weight are not succeeding.” Abernathy and Black22 stated that more emphasis should be placed on risk factors and healthy lifestyles and less on height-weight tables and body-fat percentages.
100 200 300 400 500 600 700 800 900 1000 1100 1200 1 5.0 2.5 1.7 1.3 1.0 0.8 0.7 0.6 0.6 0.5 0.5 0.4 2 10.0 5.0 3.3 2.5 2.0 1.7 1.4 1.3 1.1 1.0 0.9 0.8 3 15.0 7.5 5.0 3.8 3.0 2.5 2.1 1.9 1.7 1.5 1.4 1.3 4 20.0 10.0 6.7 5.0 4.0 3.3 2.9 2.5 2.2 2.0 1.8 1.7 5 25.0 12.5 8.3 6.3 5.0 4.2 3.6 3.1 2.8 2.5 2.3 2.1 6 30.0 15.0 10.0 7.5 6.0 5.0 4.3 3.8 3.3 3.0 2.7 2.5 7 35.0 17.5 11.7 8.8 7.0 5.8 5.0 4.4 3.9 3.5 3.2 2.9 8 40.0 20.0 13.3 10.0 8.0 6.7 5.7 5.0 4.4 4.0 3.6 3.3 9 45.0 22.5 15.0 11.3 9.0 7.5 6.4 5.6 5.0 4.5 4.1 3.8 10 50.0 25.0 16.7 12.5 10.0 8.3 7.1 6.3 5.6 5.0 4.5 4.2
WeeKs needed to lose Weight at various CaloriC defiCits
Table 12–4
*Calorie deficit = calories expended minus calories consumed. Each 3500-calorie deficit produces loss of 1 pound of fat. Most moderately active people need about 15 calories per pound to maintain their weight. © 2011, Stephen Barrett, M.D.
Daily Calorie Deficit*Pounds to Lose
W ee
ks N
ee de
d
>
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eating disorders
Preoccupation with body image and dieting has stimu- lated many people to resort to extreme measures of weight control.24 Anorexia nervosa is a life-threatening condition in which food intake is severely limited. The afflicted individuals, most of whom are young women, have an intense fear of gaining weight or becoming fat, even though they are underweight. Bulimia (also called bulimia nervosa) is a disorder characterized by bingeing (episodes of eating large amounts of food) and purging (getting rid of the food by vomiting or using laxatives). In contrast with anorectics, most bulimics (a) do not get emaciated, (b) are aware that they have a problem, and (c) feel compelled to conceal it. About half of anorectics develop symptoms of bulimia, and about half of bulim- ics have a history of anorexia or eventually develop it.24
Inadequate food intake or extreme purging can cause metabolic imbalances that result in fatigue, irregular
heartbeat, thinning of the bones, and cessation of men- struation. Frequent self-induced vomiting can damage the stomach and esophagus, make the gums recede, and erode tooth enamel. Approximately 0.5% to 1% of females between the ages of 15 and 30 become anorexic and 1% to 3% of adolescent and college-age women have bulimia.25
Eating disorders may require psychologic and di- etary counseling, as well as medical treatment for any physical ailments that have developed. If a patient’s weight becomes dangerously low, hospitalization with intensive therapy is recommended. Medical treatment for anorexia may require tube feedings or hyperalimentation (complete nutrition through the veins) if the patient will not or cannot eat. Dietary counseling may help an ano- rectic individual understand the importance of nutrition and instill healthy eating behaviors. Psychologic therapy should aim for greater self-understanding, clarification of family dynamics, and the development of the patient’s
People who have met me within the last 25 years find it hard to believe that I was once a third bigger than I am now. Like many women in their early 20s, I had become obsessed with weight and quite miserable about the extra pounds that had begun to clutter up my five-foot frame. So, like millions of others in the same boat, I tried diet- ing. All kinds of diets. Many commercial programs and gimmicks and a few I made up on my own. And sure, I would lose weight, but then I’d gain it back—and usually some extra pounds to boot—when I got sick and tired of feeling deprived and living on eggs and grape fruit or cottage cheese and carrots or whatever happened to be the popular weight-loss concoction of the day. Believe me, I tried them all—even the ridiculous drinking man’s diet—and all they did was result in an ever-bigger me. Then one day I panicked. I was fat. But even more important, I realized, I was probably killing myself with my atrocious eating habits. I vowed to turn over a new leaf. I decided that if I was going to be fat, so be it, but at least I could be healthy and fat. I gave up diets and gimmicks and cycles of starv- ing and bingeing, and I started eating: three wholesome meals, with wholesome snacks if I was hungry between meals, and one little “no-no” each day—two cookies, a couple of spoons of ice cream, a thin sliver of cake or pie—something I loved and did not want to miss. No deprivation, no star vation, no bingeing. Only moderation.
And I put myself on a regular exercise program. Every day I would do something physically chal lenging: walk- ing, cycling, skating, swimming, tennis—something that got me breathing hard (I kept thinking about how all that oxygen was restoring my cells to health) and feeling good about my body. Losing weight wasn’t part of this plan, but lose weight I did. Even though I was eating whenever I was hungry and consuming what felt like mountains of food, I lost weight: about seven pounds the first month and then about one or two pounds a month thereafter, until my weight stabilized two years later at 35 pounds lighter. And there it has stayed, give or take five pounds here or there, for a quarter-century. Trying to lose weight fast is probably the single big- gest mistake dieters make. Weight that comes off quickly nearly always comes back on even faster. You didn’t gain those extra pounds in a fortnight, and you shouldn’t be trying to take them off in two weeks, or even necessar- ily in two months or two years. The idea is to adopt an eating and exercise plan that you can go on and can stay on for the rest of your life, a program that will allow you to lose weight slowly, tone up your body gradually and eventually stabilize at a weight and shape that is right for you. Jane Brody23 Personal Health Columnist The New York Times
A Plug for Fitness
Personal Glimpse
Chapter Twelve Weight Control 239
Weight-Control MYths vs faCts
Table 12–5
Myth: You can’t get fat on a low‑fat diet. Fact: Restricting fat intake is useful in weight control and has distinct health advantages in terms of coronary heart disease and cancer. However, while it is more difficult to gain weight on a low-fat diet than a high-fat diet, it is by no means impossible. The net calories available to your body still count, whether they come from fat or carbohydrates. No matter what the source, if you eat more calories than you burn, the excess is stored as fat. People gain weight every day from too many calories from low-fat ice cream, cakes, cookies, mayonnaise, and margarine.
Myth: Obesity results from psychologic problems. Fact: For many years, some people suffering from obe- sity underwent treatment for emotional distress under the assumption they were anxious or depressed and ate to compensate for some inner need. This simply is not true. For example, epidemiologic surveys have shown that neither manic/depressive illness nor schizophrenia is more common among obese than among lean people.
Myth: People who binge‑eat do so because they have a deep sugar/carbohydrate craving. Fact: Laboratory studies have revealed that the food preferences of people with binge eating disorder, or a related “binge-purge” disorder known as bulimia, aren’t very different from those of the normal population. The problem is they can’t control the amount they eat. More recent studies suggest they may have a physiologic disturbance that begins at some point after the onset of the disorder and affects their sense of satiety. In other words, they may not experience the sense of fullness that normally occurs at the end of a meal until they have consumed an excessive amount of food.
Myth: Obese people can “eat like a bird” and still not lose weight. Fact: Researchers at St. Luke’s-Roosevelt Hospital Center have found that obese men and women tend to under report the number of calories they actually con- sume. The fact is that, all things being equal, if they did eat very little, they would lose weight.
Myth: Since genetics and obesity can be linked, trying to control obesity by diet won’t work. Fact: Despite your family history, the number of calories you consume still plays an important role in determining whether you will lose or gain weight.
Myth: Through diet and exercise, you will be able to change the way your body fat is distributed. Fact: The location of body fat may be a direct result of whether you are male or female, your genetic makeup, your age, and whether you are under stress, smoke or drink. Diet and exercise may slim you—and improve your health—but won’t change fat distribution.
Myth: Once obese people bring their weight down to a desirable level, that level can be easily maintained by eating the usual, moderate amount of calories. Fact: The body tends to resist intervention that lowers or raises its fat content. Scientists have found that re- ducing weight causes some metabolic processes to slow down so that it takes fewer calories than before to make you gain weight again. In other words, to maintain the same healthy weight, an obese person who has reduced often must eat fewer calories than someone who’s never been obese. It’s one reason for the high recidivism rate among dieters. The reverse is also true. Gaining weight increases energy expenditure, which means that if you’ve been thin, it will take more calories than ever to keep your weight up.
Myth: Obesity is due to a simple lack of willpower. Fact: The bulk of research evidence shows that there is a strong genetic component to obesity, which may re- flect a special vulnerability to an environment in which calorie-rich foods are relentlessly promoted. Several genes have been identified that not only influence appe- tite and satiety, but may also affect how efficiently the body stores food calories.
Myth: Eating slowly will make you feel full faster, thus helping to reduce food intake during mealtime. Fact: There is no concrete evidence to support this claim. Recent laboratory studies in which eating rates were manipulated and food intake was measured showed no effect on the amount of food eaten.
Myth: Certain fats, such as fish oils and olive oil, are not fattening. Fact: Studies show that, like saturated fats, monoun- saturated fats (such as olive oil, which is associated with the popular Mediterranean diet) and polyunsatu- rated fats (such as fish and vegetable oils) are fattening. Although there is a difference in the way various fatty acids are metabolized in the body, all fats can promote obesity and should be eaten in moderation.
Research findings have revised many long-held beliefs and assumptions about obesity. These examples were as- sembled by the Nutrition Research Center at St. Luke’s-Roosevelt Hospital Center and the Nestlé Research and Development Center, Inc.
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own individual personality. Additional information about eating disorders can be obtained from the National As- sociation of Anorexia Nervosa and Associated Disorders. Eating disorders are common among participants in some of the performing arts and among athletes in sports that emphasize leanness or have weight classifications. The activities include ballet, dance, gymnastics, wres- tling, judo, boxing, weightlifting, bodybuilding, figure skating, diving, horse racing, and distance running. The desperate methods used to keep thin or to “make weight” for a competition include rubber suits, excessive heat in saunas, diuretics, laxatives, self-induced vomiting, excessive exercise, starvation, and dehydration—all of which have potentially dangerous consequences.
the u.s. Weight-loss MarKetplaCe
A major survey conducted in 2003 found that 65% of women and 42% of men were trying to lose weight.26 Marketdata Enterprises,3 an independent market research and consulting firm, estimated that 2010 sales of weight- loss products and services totaled $60.9 billion. The leading categories were diet soft drinks ($21.2 billion); health clubs ($19.5 billion); bariatric surgery ($5.8 bil- lion); artificial sweeteners ($2.5 billion); over-the coun- ter (OTC) appetite suppressants and meal-replacement products ($2.7 billion); low-calorie prepared foods ($2.3 billion); medically supervised diet programs ($2.5 bil- lion); commercial weight-loss center programs ($3.3 billion); and diet books, cassette tapes, and exercise videos ($1.2 billion).
QuestionaBle diets
Most fad diets, if followed closely, will result in weight loss—as a result of caloric restriction—but they are mo- notonous and often dangerous to health if followed for long periods. Yet many obese individuals are sufficiently desperate or gullible to try one questionable method after another. A highly publicized diet will attract many people who try it for a short period, lose weight, and encourage others to do the same. Because most will regain their lost weight, the market for “new” diets is inexhaustible. Dr. Philip L. White, former director of the AMA Department of Foods and Nutrition, warned against try- ing any method promised to induce weight loss of more than 2 pounds a week. He gave these additional tips for spotting an unreliable diet promotion27: • It suggests that a nutrient or food group is either the key to
weight reduction or the primary “villain” that keeps people overweight.
• It claims to be a revolutionary new idea.
• It reports testimonials rather than documented research. • It refers to the author’s own case histories, but does not
describe them in detail. • It claims 100% success. • The promoter claims persecution by the medical profession.
When questionable diets are promoted with refer- ence to research studies, the research is typically unpub- lished, poorly designed, published in obscure outlets, and/or based upon studies on animals rather than people. The National Council Against Health Fraud28 warned consumers to be wary of any weight-control program that encourages the use of special products rather than learning how to make wise food choices from the con- ventional food supply. Most fad diets lack important nutrients or even whole food groups and are therefore nutritionally unbalanced. The three main types of unbalanced approaches to weight loss are complete fasting (starvation), supplemented fasting, and low-carbohydrate (high-protein) diets. Complete Fasting The most drastic way to reduce caloric intake is to stop eating. Intake of water, of course, is still necessary. Fast- ing has been used for weight reduction since ancient times. Losses will be greatest in the heaviest people and least in individuals who are the lightest. A few days of fasting are unlikely to be dangerous, but prolonged fast- ing leads to dangerous metabolic imbalances. Glucose is essential for the brain and is the preferred fuel for other body tissues. Glucose is obtained easily from carbohydrates, less easily from proteins, but not at all from fats. After a few days of total fasting, body fats and proteins are metabolized to produce energy. The fats are broken down into fatty acids, which can be used as fuel. If sufficient carbohydrate is not available, the fatty acids may be incompletely metabolized and yield ketone bodies, causing a condition called ketosis. This situation, if prolonged, is hazardous because proteins must be broken down to ensure an adequate supply of glucose for the brain. During fasting, because no proteins are available from food, they are obtained from muscles and major organs such as the heart and kidneys. A pro- longed fast can also lead to anemia, liver impairment, kidney stones, postural hypotension (low blood pres- sure), mineral imbalances, and other adverse effects. Part of the reason for fasting’s popularity is that it produces dramatic weight loss during its early stages. As ketosis begins, large amounts of water will be shed, leading the dieter to think that significant weight reduc- tion is taking place. However, most of the loss is water rather than fat; the lost water is regained quickly when eating is resumed. Appetite, often reduced during ketosis,
Chapter Twelve Weight Control 241
also returns when a balanced diet is resumed. Claims that fasting “cleanses the body of toxic chemicals” are false. Supplemented Fasting Medical researchers have discovered that if fasting in- dividuals eat small amounts of protein, the protein will break down slowly to provide the glucose needed by the brain. Eating carbohydrates for this purpose does not work because it triggers an insulin response that causes intense hunger. In the early 1970s Dr. George Blackburn and colleagues at the Deaconess Hospital in Boston developed the “protein-sparing modified fast” in which fasting patients were given small amounts of high-quality protein along with noncaloric liquids, vitamins, calcium, potassium, other minerals, and some- times glucose. Patients were initially hospitalized for 1 week of evaluation and then followed-up closely as outpatients. Their diets were carefully calculated. The program emphasized not only diet but also an overall approach that included exercise, instruction in nutrition, and behavior modification. Today, modified fasting can be done safely on an outpatient basis under skilled medical supervision. However, experts have expressed fears that the vigorous marketing of meal-replacement drinks will encourage people to use these products inappropriately. The more meals replaced and the lower the number of calories consumed daily, the greater the risk. The risk is greatest in individuals who are not severely overweight. The FDA requires a warning label on weight-reduction products if more than half of their calories come from protein. Very-low-calorie (VLC) diets contain fewer than 800 calories per day, most of them from high-quality proteins, plus vitamins and minerals, particularly potassium. Some programs use liquid formulas, whereas others utilize food sources (poultry, fish, and lean meats). In 1993, the National Task Force on the Prevention and Treatment of Obesity29 recommended against their use because (a) clinical trials had shown that low-calorie diets are just as effective, and (b) VLC dieters are at increased risk for developing gallstones.
Low-Carbohydrate Diets Most low-carbohydrate diets do not explicitly limit the intake of proteins, fats, or total calories. Some promot- ers claim that unbalancing the diet will lead to increased metabolism of unwanted fat even if the calories are not restricted. This is not true, but calorie reduction is likely to occur because the diet’s monotony tends to discourage overeating. A diet that is very low in both carbohydrates and calories will produce ketosis and rapid initial weight loss, as noted in the Complete Fasting section.
Some promoters of low-carbohydrate diets regard carbohydrates as “the dieter’s number one enemy.” This designation is inappropriate because calories from any source contribute equally to weight gain if consumed in excess. Some diets that restrict carbohydrates permit enough to be eaten that they do not produce ketosis. The most popular of these is the South Beach Diet,30 which was published as a book in 2003. This diet is based on the premise that eating the wrong carbohydrates causes blood sugar to soar, which triggers an insulin response that drops the blood sugar and causes carbohydrate cravings that result in overeating. The Tufts University Health & Nutrition Letter31 says that any such reaction is a minor factor in weight control and that, “like many popular diet books, this one is replete with faulty science, glaring nutrition inaccuracies, contradictions, and claims of scientific evidence minus the actual evidence.” The least restrictive of the popular low-carbohydrate diet books is The Zone32 which advocates eating 40% carbohydrate, 30% protein, and 30% fat at every meal. The book defines the “zone” as a metabolic state in which the body operates at optimal efficiency. It further claims that maintaining a 4:3 ratio between carbohydrates and proteins triggers hormonal changes that burn off excess body fat and produce health-promoting eicosanoids. Cheuvront33 has dissected the book’s theories and con- cluded that they lack scientific support. Researchers who compile the National Weight Con- trol Registry analyzed the diets of 2681 members who had maintained at least a 30-pound weight loss for 1 year or more. They found that fewer than 1% had followed a diet similar to the Atkins program. Most followed high- carbohydrate, low-fat diets.34
The most publicized low-carbohydrate diet is the one advocated by the late Robert C. Atkins, M.D., of New York City, whose books sold millions of copies. Atkins advocated his diet for more than 30 years and stated that more than 60,000 patients treated at his center had used his diet as their primary protocol. However, he never published any study that documented what happened to his patients. The current Atkins plan35 has four steps: a 2-week “induction” period, during which the goal is to reduce carbohydrate intake to under 20 g per day, followed by three periods during which carbo- hydrate intake is progressively raised but kept below what Atkins called “your critical carbohydrate level” for losing or maintaining weight. The dieter was permit- ted to eat unlimited amounts of noncarbohydrate foods “when hungry,” but ketosis tends to suppress appetite. In 2000, researchers who analyzed sample menus from Atkins’s books reported that the diet contained 59% fat
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and provided fewer servings of grains, vegetables, and fruits than recommended by the U.S. Dietary Guidelines. The investigators warned that although the diet can pro- duce short-term weight loss, long-term use was likely to increase the risk of both cardiovascular disease and cancer.36
Recent studies have found that low-carbohydrate diets can produce modest weight loss and reduction in cardiac risk factors, which means that they are safer than previously thought. The most comprehensive such study was reported in 2009 by Sacks and others,37 who fol- lowed 811 overweight adults for 2 years. Each participant was assigned to one of four reduced-calorie diets with the following targeted percentages of calories derived from fat, protein, and carbohydrates: 20/15/65, 20/25/55, 40/15/45, or 40/25/35. Among the 80% of participants who completed the trial, the average weight loss was about 9 pounds, and 14% to 15% of the participants lost at least 10% of their initial body weight. Satiety, hunger, satisfaction with the diet, blood lipid levels, and attendance at instructional sessions were similar for all four groups, but those who attended the most in- structional sessions tended to have the best results. The researchers concluded: “Reduced-calorie diets result in clinically meaningful weight loss regardless of which macronutrients they emphasize.” However, it has not been determined whether using a low-carbohydrate diet for many years is safe or can reduce the incidence of coronary heart disease. Low-carbohydrate diets are unsuitable for people with coronary artery disease, gout, or kidney disease. In addition to being checked for these conditions, low- carbohydrate dieters should have their blood cholesterol levels monitored and should stop the diet if their 3-month total or LDL-cholesterol levels rise sharply. Among those whose cholesterol levels improve, the improve- ment is thought to be related to weight reduction, but no published study has examined the effect of the diet on the coronary arteries. Because increasing the amount of carbohydrates in a diet can raise triglyceride levels and reduce HDL, a low-carbohydrate diet may be appropriate for obese individuals with abnormally high triglyceride levels.38 Future genetic research may be able to determine which diets are best for which people. The popularity of low-carbohydrate diets has en- couraged food companies to market low-carbohydrate foods for people who want to “watch their carbs.” Most of these foods are much higher in fat than the foods they are designed to replace. Thus “low-carb” advertising is encouraging both dieters and nondieters to eat high-fat foods, which is exactly the opposite of what medical and nutrition authorities have been urging for decades.
Bizarre Theories Countless dietary plans have been based on theories that do not correspond to scientific knowledge of physiology or biochemistry. Here are four examples. Fit for Life39 advocates “Natural Hygiene” theories that eating foods in the wrong combination can cause health problems (see Chapter 8). The book’s authors, Harvey and Marilyn Diamond, lack scientific training in nutrition but acquired credentials from the American College of Health Science, a nonaccredited correspon- dence school that in 1986 was ordered by a Texas court to stop granting “degrees” and calling itself a college.40 According to the Diamonds, when certain foods are eaten together, they “rot” and “decay,” creating digestive cess- pools that somehow poison one’s system and make one tired and fat. They recommend a low-fat, high-fiber diet with foods high in water content to “wash out the body from the inside.” These ideas are nonsensical. Katherine Musgrave, a University of Maine nutrition professor, did a computerized analysis of the diet and concluded that it was inadequate in calcium, zinc, and vitamins B12 and D.41 Despite enormous criticism from the scientific community, the book sold 2 million copies during the 1980s and, along with revised editions, is still selling briskly. At the height of the book’s popularity, National Council Against Health Fraud President Dr. William T. Jarvis42 stated:
Fit for Life seems unprecedented in the amount of misinforma- tion contained. It is appalling that such a book can become a best seller in the latter half of the 20th century. Its only socially redeeming feature is that its popularity may alert American educators of their failure to impart the most fundamental knowledge about health and nutrition to students entrusted to their care.
The Perricone Weight‑loss Diet43 is based on the idea that the cause of obesity is inflammation and that the cure is to avoid “inflammatory foods” (e.g., sweets) and eat “anti-inflammatory foods.” According to the book, eating brightly colored fruits and vegetables and foods high in omega-3 fatty acids (like fish) will “cause you to rapidly lose body fat, maintain muscle mass, give you mental and physical energy and keep your mood elevated.” The author, Nicholas Perricone, M.D., has written several books that make similar unfounded claims about diet and skin health (see Chapter 18). Several plans are based on alleged “typing” systems that classify people according to some characteristic and then recommend restricting or emphasizing certain foods according to the type. The most popular such plan is promoted by the book Eat Right 4 Your Blood Type,44 by a naturopath who claims that blood type determines
Chapter Twelve Weight Control 243
how people react to nutrients and therefore should guide dietary choices. Elliot Abravanel, M.D., co-author of Dr. Abravanel’s Body Type and Lifetime Nutrition Plan45 and Dr. Abra‑ vanel’s Anti‑Craving Weight Loss Diet, claims there is a “dominant gland” at the root of every weight problem and that weight can be controlled by soothing the errant gland and moderating its cravings. The books advise tailoring a corrective plan to the individual’s “body type,” which is determined by completing a question- naire about the person’s shape, body fat distribution, food cravings, sleep patterns, and various other characteris- tics (Figure 12-1). They classify women as “thyroid,” “pituitary,” “adrenal,” or “gonadal” type, whereas men can be classified as “thyroid,” “pituitary,” or “adrenal.” The personality traits described for each type resemble those of a typical horoscope. Nature’s Sunshine, which marketed products based on these notions, advised which “foods to eat or avoid” and “herbs to use when the urge to snack strikes” for each body type. All dieters were advised to begin with a 2- to 3-day “cleanse,” engage in aerobic exercise, and aim for an overall calorie count of 1200/day for women or 1400/day for men. Raso,46 who investigated the company in the early 1990s, noted that most people who exercise and restrict calories to such levels would lose weight with or without the products.
presCription drugs
No drug or drug product can ensure permanent weight loss. Some products can suppress appetite temporarily, but side effects or other negative characteristics limit their usefulness. Amphetamines (“speed”) were once widely pre- scribed as appetite suppressants. Their adverse effects and potential for addiction outweigh any usefulness as a dieting aid. Although they can temporarily curb ap- petite, the effect will wear off after a few months unless dangerously high doses are prescribed. Amphetamines can cause nervousness, irritability, insomnia, and fatigue. High dosages can cause abnormal heart rhythms, faint- ing, and psychotic reactions. Thyroid hormone helps to control metabolism (the rate at which calories are used up by the body). However, unless a documented deficiency of this hormone exists, use of thyroid supplements is inadvisable. Small doses given to normal individuals merely suppress normal thyroid hormone production and have no metabolic effect. Large dosages will cause weight reduction, but they will also raise blood pressure and strain the heart. The FDA requires the labels on thyroid products to warn that they should not be used for obesity and that large doses produce serious and life-threatening effects. Diuretics are substances that cause water loss from the body by increasing the output of urine. They can be very valuable in the medical treatment of cardiovascular disease, but are inappropriate for use in weight-reduction programs. Any weight loss that results from water loss is temporary and will be reversed when the body is rehy- drated. In addition, improper use of diuretics can cause a dangerous depletion of body sodium or potassium. Orlistat (Xenical) works by blocking enzymes in the intestine that normally digest fat, thereby reducing its absorption. An over-the-counter version (Alli) con- tains half the dose of Xenical. Studies have found that groups who took orlistat for 1 year along with diet and exercise lost about 7 more pounds than similar groups who received a placebo. However, many users experi- enced diarrhea, fecal incontinence, flatulence, and other unpleasant side effects, and serious liver injury has been reported. Consumers Union47 advises that the risks vastly outweigh the benefits. A number of other drugs that resemble amphet- amines have received FDA approval, but many have been withdrawn because of serious adverse effects.48 Drugs in this class, such as phenteramine, are now approved only for short-term (up to 12 weeks) use, which is associated with an average weight loss of 3 pounds.Figure 12-1. Advertising slick for GlanDiet Program.
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nonpresCription produCts
During the 1970s an FDA advisory panel evaluated more than 100 substances that had been used in weight-loss formulas. The panel’s 1979 report concluded that some had no pharmacologic activity at all and that many were not worth considering because no shred of evidence sug- gested that they could be helpful. The panel judged only two ingredients safe and effective: phenylpropanolamine (PPA) and benzocaine. In 1992, the FDA banned argi- nine, caffeine, kelp, guar gum, lecithin, papaya enzymes, phenylalanine, tryptophan, vitamin B6, and 102 other substances as ingredients in weight-loss products, but the substances can still be marketed as “dietary supple- ments” without claims for weight control. In 2000, the agency banned PPA because of reports of hemorrhagic strokes among its users between the ages of 18 and 45. Benzocaine Benzocaine, a local anesthetic, is used in chewing gum, lozenges, and before-meal candies. The theory behind its use is that dulling nerve endings in the mouth can decrease a person’s sense of taste and therefore decrease interest in eating. Benzocaine was also judged by the 1979 FDA panel as a safe and effective weight-loss aid, but most medical authorities did not agree with the panel’s conclusion. Mirkin49 stated:
People who lack the will to diet effectively without benzocaine can hardly be expected to put up with the drug indefinitely either. It tastes bad, creates numbness in the mouth, and re- moves most of the taste in all food, not just fattening food. It can discourage a worthwhile effort to learn good eating habits, and it is never an adequate substitute for those habits.
In 2011 the FDA, after concluding that there is insuf- ficient evidence of safety and effectiveness, proposed to ban benzocaine as an OTC weight-loss ingredient.50
Ma Huang (Ephedra) Ma huang is an herb that contains ephedrine, a decon- gestant and nervous-system stimulant that can raise blood pressure. Products containing ma huang have been marketed as weight-loss aids, even though they have not been proven safe and effective for this purpose. In 2003, a review concluded that a few clinical trials had demonstrated modest weight loss for 4 to 6 months, but most of the studies were poorly designed and none had assessed the long-term results.51 Between 1993 and 2003, the FDA received thou- sands of reports of adverse events among people taking ephedra supplements, including heart attacks, strokes, seizures, and more than 100 deaths.52 Yet it took the agen- cy many years to ban ephedra as a dietary supplement
ingredient because the 1994 Dietary Supplement Health and Education Act makes it extremely cumbersome to prove that a product is unsafe. Meanwhile, hundreds of private lawsuits were filed against various marketers and the legislatures in Illinois, New York, and California banned the sale of ephedra products. In 2004, the FDA banned the sale of dietary supple- ments containing ephedrine alkaloids53 and sued a few manufacturers who were still marketing such products. Because of the legal risks, nearly all companies that had been marketing ephedra products for weight loss dis- continued them, but some began selling “ephedra free” products that contain bitter orange. In 2005, Haller and others54 tested two such products and found that they increased the heart rate of healthy volunteers, which may be reason for concern. The largest marketer of ephedra products was Metabolife International. In 1999, while the FDA was considering a ban, Metabolife’s president Michael J. El- lis falsely told the FDA that the company had received no complaints. After the truth came out, Ellis pleaded guilty to lying to the FDA and in 2008 was ordered to serve 6 months in prison and pay a $20,000 fine.55
Diet Teas Many teas have been marketed with claims that they can help people lose weight. No such tea has been proven effective for this purpose, and some contain laxatives that can be dangerous if consumed in large quantities. Inves- tigative reporter David Zimmerman56 noted the cases of two women who died unexpectedly in 1991 while using a tea that contained senna, a powerful laxative. The FDA and the California Department of Health received about two dozen other complaints from users of the tea, most of whom complained about cramps and diarrhea. In 2009, Coke, Nestle, and Beverage Partnership Worldwide (BPW) settled charges that they falsely ad- vertised that Enviga, a green tea beverage, would result in weight loss by burning extra calories. The charges were brought by a coalition of 26 states and the District of Columbia, led by Connecticut Attorney General Richard Blumenthal. The settlement requires that in any market- ing of Enviga or a similarly formulated product claimed to burn calories there must be a clear and conspicuous disclosure that the product does not produce weight loss without diet and exercise. The companies agreed to pay $650,000 to the states.57
Hoodia Gordonii Hoodia gordonii, a plant found in South Africa, is said to have been used for centuries to keep tribesmen from feeling hungry during long hunts. Extracts have been
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widely claimed to suppress appetite, but no scientific studies have demonstrated this.58
Bulk Producers Bulking agents are indigestible, noncaloric substances that absorb water during digestion and supposedly trick the stomach into thinking it is full. The substances in- clude alginic acid, carboxymethylcellulose, carrageenan, guar gum, karaya gum, methylcellulose, psyllium, kelp, and xanthan gum. The FDA panel judged these sub- stances to be safe but not proven effective. Dr. Ernest Drenick59 of Los Angeles, who tested methylcellulose tablets in volunteers, found that they experienced no reduction in hunger or appetite. He also demonstrated with x-ray examination that methylcellulose does not actually fill the stomach but quickly passes into the small intestine. Drenick noted that there is no evidence that increasing the volume of a meal will produce satiety in obese individuals. Two other bulking agents—glucomannan and pectin—have been widely promoted in weight-loss prod- ucts. Glucomannan is a soluble fiber found in the roots of a Japanese plant. Controlled studies have found that increasing glucomannan intake through pills or foods for 3 to 16 weeks produced an average weight loss of about 1 pound—an amount far less than has been claimed by weight-loss product promoters.61 Pectin has been mar- keted in powder and tablet form as a wonder drug for
weight reduction. It is naturally present in a number of foods such as apples, apricots, plums, the rinds of citrus fruits, and root vegetables such as carrots and radishes. Pectin has no proven value as an appetite suppressant. “Fat-Modifying” Substances Conjugated linoleic acid (CLA), chitosan, pyruvate, Ir‑ vingia gabonensis, chia seed, and Garcinia cambogia are claimed to produce weight loss by altering fat absorption, fat metabolism, and/or fat storage. Egras and others62 have concluded that there is little clinical evidence to support their use and some can cause gastrointestinal symptoms. CLA is a naturally occurring fatty acid that is found in beef and dairy products. It is believed to cause weight loss by promoting the death of fat cells. Animal studies suggest possible usefulness for weight-reduction, but well-designed human trials have been negative.62
Chitosan is derived from chitin, a polysaccharide found in the outer skeleton of shellfish such as shrimp, lobster, and crabs. Many sellers claim that chitosan causes weight loss by binding fats and preventing them from being absorbed. But only one out of four double- blind studies found that people taking chitosan lost more weight than those who received a placebo.62 Chitosan should be avoided by people with a shellfish allergy. Pyruvate is a byproduct of glucose metabolism. One research team has reported benefit, but the studies were short-term and not confirmed by others.62 Irvingia gabonensis is a mango-like fruit from a forest tree found in West Africa. One research team has reported benefit, but the data are too limited to draw conclusions.62
Chia seed (Salvia hispanica) is a sprout that has high concentrations of omega-3-fatty acids, alpha-linoleic acid, and fiber. One study found benefit, but the data are too limited to draw conclusions.62
The active ingredient in Garcinia cambogia is hy- droxycitric acid. The best-designed study that compared hydroxycitric acid with a placebo found no benefit.63
Starch Blockers “Starch blockers” have been promoted as containing an enzyme extracted from beans that, when taken be- fore meals, supposedly blocks digestion of significant amounts of dietary starch. The enzyme works in the test tube, but the body produces more starch-digesting en- zymes than starch-blocker pills could possibly block. A 1982 study found no evidence in the feces of pill-takers that starch digestion was actually blocked.64 Moreover, if undigested starch does reach the large intestine, it is fermented by bacteria normally present, leading to gas
Criminal Prosecution60
In 2010, Frank Sarcona (a/k/a Frank Sarcone), whose career as a mail-order scammer spanned more than 30 years despite more than a dozen government enforce- ment actions, was sentenced to 20 years in prison for a long list of crimes related to selling worthless diet pills. In 2009, Sarcona was convicted of 29 criminal charges that included conspiracy to commit mail and wire fraud; conspiracy to commit money laundering; and multiple counts of mail fraud, wire fraud, money laundering, misbranding of a food, and criminal contempt of court. Court documents indicate that he defrauded more than 130,000 customers out of more than $7 million by making false claims that LipoBan (a chitin product) would produce weight loss without rigorous exercise or dietary change and that one user had lost “over 126 pounds in 120 days,” which is way beyond what is humanly possible. The case is remarkable because diet- pill swindlers are almost never criminally prosecuted and the 20-year sentence is one of the longest ever issued for quackery-related activities.
Personal Glimpse
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production and causing digestive disturbances. Some users of starch blockers have experienced abdominal pain, nausea, vomiting, and diarrhea, probably caused by toxic contaminants in the product. Sugar Blockers “Sugar blockers” containing an extract of Gymnema sylvestre, a plant grown in India, are claimed to cause weight loss by preventing sugar in the diet from being absorbed into the body. Chewing the plant’s leaves can prevent the taste sensation of sweetness, but there is no reliable evidence that the chemicals they contain can block the absorption of sugar into the body or cause weight loss. Chromium Picolinate Health-food publications and various manufacturers have claimed that chromium picolinate supplements can melt fat away and reduce body fat without dieting or exercise. Some note that the process for synthesizing picolinates was developed at the U.S. Department of Agriculture Human Nutrition Research Center in Grand Forks, N.D., and that USDA holds the patent. However, Hank Lukaski, the research leader at the North Dakota facility, has stated that chromium picolinate has no ef- fect on body fat.65 Well-designed studies have found no weight-control benefit, and a tissue-culture study66 has raised the question about whether chromium picolinate can cause cancer.
Hormonal Fakery Following the publication of Life Extension,67 by Durk Pearson and Sandy Shaw, many companies began sell- ing combinations of the amino acids arginine, ornithine, and tryptophan. Products of this type (Dream Away, Super‑Amino Night, Nite Diet) were claimed to cause weight loss through growth hormone release (GHR). However, as noted by Lowell68: (a) amino acid pills do not cause growth hormone release; (b) growth hormone release would be unlikely to cause weight loss; and (c) if significant amounts of this hormone were released in the body, it could cause acromegaly, a disease in which the hands, feet, and face become abnormally large and deformed. In 1988 the FTC charged the makers of Dream Away with false advertising and asked an Arizona fed- eral court to issue an injunction and order them to pay consumer redress.69 A few months later the defendants agreed to place $1.1 million in an escrow account to repay purchasers and pledged not to misrepresent any food, drug, or device in the future. However, other al- leged GHR diet pills are still marketed.
Cholecystokinin (CCK) is a hormone involved in the digestive process. Products said to contain CCK have been marketed with claims that they can decrease hunger and cause sudden and dramatic weight loss. However, although injections of CCK appear to decrease hunger in test animals, doses taken by mouth have no such effect. Dehydroepiandrosterone (DHEA) is a hormone that can reduce weight gain in some strains of mice and rats. Based on this fact, several companies have mar- keted DHEA products as “miracle weight-reducers.” Cunningham70 has pointed out that “people who use DHEA with the hope of losing weight are unlikely to succeed and could endanger their health by tampering with their hormones.” Human chorionic gonadotropin (HCG) is a hormone found in the urine of pregnant women. More than 50 years ago, Dr. Albert T. Simeons, a British-born phy- sician, contended that HCG injections would enable dieters to subsist comfortably on a 500-calorie-a-day diet. He claimed that HCG would mobilize stored fat; suppress appetite; and redistribute fat from the waist, hips, and thighs. However, many studies have refuted these claims.71 Moreover, a 500-calorie (semi-starvation) diet is likely to result in loss of protein from vital organs, and HCG can cause other adverse effects.
loW-Calorie produCts
Many low-calorie foods and beverages are available for use by weight-conscious individuals. These include liquid or powdered preparations (to which water is added) to consume instead of a meal, low-fat foods such as salad dressings made without oil, and foods and beverages made with artificial sweeteners. Well-designed studies to measure the effectiveness of such products for weight control are scarce, but some people seem to find these products helpful. Some experts, however, speculate that low-calorie and low-fat foods have been a factor in America’s rising obesity rates because some people consume too much of them.72
FDA Definitions According to FDA guidelines, “low-calorie” foods cannot contain more than 40 calories per serving or 0.4 calories per gram. Foods labeled “reduced calorie” are not limited in calories per serving, but they must be at least 25% lower in calorie content than similar foods that contain the usual amount of calories. Foods that are labeled “low calorie” or “reduced calorie” must also bear nutrition labeling that includes serving size and calories per serving in addition to significant nutrient
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values. If a standardized food is modified so that it no longer complies with the standard, the food must be labeled “imitation.” Because consumers would reason- ably expect food labeled “sugar-free” or “sugarless” to be reduced in calories, the label must alert them if this is not the case. If the word “light” (or “lite”) appears on the label, the food is likely to be reduced in calories. Under FDA regulations (see Chapter 10), these words are permissible for foods that contain one-third fewer calories than the referenced food; any other use of the term must specify if it refers to color, taste, or odor. FDA regulations also state that the actual number of calories in a food may be more than 20% greater than the amount claimed in advertising or on the label. In 2007 and 2008, Tufts University researchers found that the calorie content of 7 out of 29 quick-serve and sit-down restaurant foods and 3 out of 10 frozen meals purchased from supermarkets exceeded the 20% limit.73
Meal-Replacement Drinks Slim‑Fast, Dyna‑Trim, and various other drink mixes contain protein, sugars, fiber, vitamins, and minerals. A Consumer Reports74 survey found little evidence that they are effective. Most respondents who used them replaced one meal a day or less, but one out of six used them for more than half their meals. The average weight loss was only 4% of starting weight for men and 3% for women. Two-fifths lost less than 5 pounds, and one-fifth gained 5 pounds or more. More than one-third said they were “always hungry” while using the drinks, and nearly as many reported that they started to regain weight as soon as they stopped using the products. However, a subsequent study found that experimental subjects who used a Slim‑Fast program over a 4-year period had lost an average of 20 pounds, whereas similar subjects who did not use the product lost an average of 9 pounds.75 All of the subjects had dietary counseling that included personalized menus. The researchers cautioned that the results may not reflect what happens to people who de- cide to initiate a self-help program that includes regular purchase of the meal-replacement products.
Low-Calorie Sweeteners Artificial sweeteners (also referred to as nonnutritive sweeteners) provide a sweet taste with few or no accom- panying calories. Six currently have FDA approval: sac- charin, aspartame, acesulfame potassium (acesulfame- K), neotame, sucralose, and rebaudioside A. In 1977 the FDA announced its intention to ban saccharin after a single study found that high doses of saccharin caused bladder tumors in rats. However,
considerable outcry from both scientists and the general public prompted passage of a law to prevent a ban. The FDA withdrew its proposal in 1991 but still required saccharin product labels to warn that saccharin had been determined to cause cancer in laboratory animals. In 2000, after a National Toxicology Program review76
concluded that saccharin poses no health hazard, Con- gress enacted the Saccharin Warning Elimination via Environmental Testing Employing Science and Technol- ogy Act to eliminate the saccharin warning. Aspartame is formed from the amino acids phenyl- alanine and aspartic acid. It is used (as NutraSweet) to sweeten cereals, milk shake mixes, diet drinks, and many other foods. About 180 times as sweet as table sugar (sucrose), it does not have saccharin’s bitter aftertaste. In tabletop form it is marketed as Equal. Widespread use of aspartame has provoked some reports of headaches and various other reactions. However, a double-blind study of 40 subjects who had reported headaches after inges- tion of NutraSweet found that the incidence of symptoms after using aspartame was not significantly different from the incidence after using a placebo.77 Products containing aspartame are labeled with a warning against consump- tion by individuals with phenylketonuria (PKU), a con- genital disease in which impaired metabolism can cause phenylalanine to accumulate and cause brain damage. Although aspartame is safe for everyone else, a vicious Internet campaign78 has resulted in spurious warnings against it on thousands of Web sites. Neotame is an aspartame derivative that has been modified so that it is safe for people with PKU. It is 7000 to 13,000 times sweeter than sugar and is quickly metabolized and eliminated by the body. The FDA ap- proved it as a general purpose sweetener in 2002. Acesulfame-K, marketed as Sunette, is used in powdered drinks, puddings, chewing gum, and tabletop sweeteners. The substance is about 200 times sweeter than sucrose and is chemically unrelated to saccharin or aspartame. Unlike saccharin, it has no aftertaste. Unlike aspartame, it is not broken down by heat or digestion and passes through the body unchanged. Sucralose is a water-soluble, noncaloric powder made by substituting three atoms of chlorine for three hydroxyl groups on the sugar molecule. It tastes like sugar, has no calories, and is about 600 times as sweet as sugar. The FDA has approved it for use in beverages, baked goods, and other foods and as a tabletop sweetener. The tabletop version is marketed as Splenda. Rebaudioside A, found naturally in the Stevia rebau‑ diana plant, has been synthesized and is available under the trade names Only Sweet, PureVia, Reb‑A, Rebiana,
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SweetLeaf, and Truvia. In 2008, the FDA approved it for use in foods and beverages. Tagatose, technically known as D-tagatose, is a low- calorie sweetener derived from lactose, which occurs naturally in some dairy products and other foods. Taga- tose has been determined to be a Generally Recognized As Safe (GRAS) substance in the United States. It can- not be marketed as an artificial sweetener, but its GRAS status permits it to be used in foods and beverages. The extent to which nonnutritive sweeteners influ- ence weight is not clear. The key question is whether people who consume artificially sweetened foods will lower their daily caloric intake or will consume other foods to make up (or exceed) the potential calorie deficit. A recent review concluded that if nonnutritive sweeten- ers are used as substitutes for higher-energy yielding sweeteners, “they have the potential to aid in weight management, but whether they will be used in this way is uncertain.”79
Fat Substitutes Simplesse is a low-calorie, low-cholesterol product made of natural protein from egg white or milk. It is produced by a microparticulation process that changes protein into a form that can be used to make products with the rich taste and texture of butter, cheese spreads, creamy salad dressings, mayonnaise, and ice cream. Olestra provides no calories because it passes through the body unchanged. It is made by heating soybean oil with sugar to produce molecules composed of sucrose with six, seven, or eight fatty acid groups attached. It is similar to edible fats in most respects, including taste, but cannot be digested into smaller components because the body has no enzymes that can break it down. Olestra is marketed under the trade name Olean. It is approved for use in snack foods and may eventually be approved for blending with frying and cooking oils. Although it seems likely that fat substitutes will help individuals lower the fat content of their diet, none has been proven effective as a treatment for obesity. Nor is it known whether it is safe to replace large amounts of dietary fat with fat substitutes. Many years ago, Blackburn80 warned that “fat substitution alone will not help . . . achieve a healthy weight or win the war against obesity and the chronic diseases that accompany it. That requires cutting back on calories and eating a high-fiber, low-fat, plant-based diet.” Others have expressed concerns that olestra reduces the absorption of fat-soluble nutrients and medications and can cause gastrointestinal symptoms with excessive use. Products containing olestra must be labeled with this warning:
This product contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients. Vitamins A, D, E, and K have been added.
BariatriC surgerY
Surgery to produce weight-loss works by mechanically restricting the size of the stomach, bypassing a portion of the intestines, or doing both. Restricting the size of the stomach limits the amount of food a patient can consume at a single meal. Bypass procedures decrease the propor- tion of nutrients that are absorbed from a meal. Because complication rates are quite high, these approaches should be used only for individuals who are morbidly obese (BMIs of 40 or greater, which means they are about 100 or more pounds above desirable weight) and in danger of dying as a result. The Southern California Evidence-Based Practice Center81 has concluded that for these patients, surgery is more effective than other weight-loss methods, but insufficient data exist to judge whether it should be used for people who are not mor- bidly obese. Patients who lose considerable weight often undergo extensive surgery to remove excess skin and improve body contours.82
duBious produCts and proCedures
Many products and procedures have been marketed with claims that they can help to reduce weight of the entire body or just in selected body parts. “Spot-reducing devic- es,” all of which are fakes, are discussed in Chapter 13.
Body Wrapping Many individuals operate salons in which it is claimed that clients can trim inches off the waist, hips, thighs, and other areas of the body. These facilities use wraps or garments, with or without special lotions or creams applied to the skin. The garments may be applied to parts of the body or to the entire body. Clients are typically assured that fat will “melt away” and that they can lose “up to 2 inches from those problem areas in just 1 hour.”
However, no product can cause selective reduction of an area of the body. Although wrapping may cause tempo- rary water loss as a result of perspiration, any fluid lost will soon be replaced by drinking or eating. Figure 12-2 shows an imaginative ad inviting people to learn how to do body wrapping. Cellulite Removers The term cellulite was coined in European salons and spas to describe deposits of dimpled fat found on the
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thighs and buttocks of many women. Widespread pro- motion of the concept in the United States followed the 1973 publication of Cellulite: Those Lumps, Bumps and Bulges You Couldn’t Lose Before, by Nicole Ronsard, owner of a New York City beauty salon that specialized in skin and body care. Cellulite is alleged to be a special type of “fat gone wrong,” a combination of fat, water, and “toxic wastes” that the body has failed to eliminate. Alleged “anticellulite” products sold through retail out- lets and by mail include “loofah” sponges, cactus fibers, special washcloths, horsehair mitts, creams and lotions to “dissolve” cellulite, vitamin-mineral supplements with herbs, bath liquids, massagers, rubberized pants, brushes, and rollers. Many salons offer treatment with electrical muscle stimulation, vibrating machines, inflat- able hip-high pressurized boots, “hormone” or “enzyme” injections, heating pads, and massage. Some operators claim that 5 to 15 inches can be lost in 1 hour. A series of treatments commonly costs hundreds of dollars. “Cellulite” is not a medical term. Medical authori- ties agree that cellulite is simply ordinary fatty tissue. Strands of fibrous tissue connect the skin to deeper tissue layers and also separate compartments that contain fat cells. When fat cells increase in size, these compartments bulge and produce a waffled appearance of the skin.84
In 1998 the FDA approved a high-powered, hand- held massage tool that consists of a treatment head and two motorized rollers with a suction device that com- presses the affected tissue between the two rollers. The manufacturer is permitted to promote it for “temporarily improving the appearance of cellulite.” The procedure— called endermologie—usually takes 10 to 20 treatments, and one or two maintenance treatments per month are required to maintain them. Prices quoted on the Internet in 2011 ranged from $50 to $100 per session. Two studies have found endermologie to be ineffective. In the larger one,85 only 10 of 35 women who had the procedure twice
a week for 12 weeks concluded that the appearance of a treated leg had improved. However, measurements of thigh girth and thigh fat depth by the researchers found no measurable change. The study also tested applications of aminophyllin cream and found no measurable effect. The researchers concluded that neither of these methods is effective in improving the appearance of cellulite. Experts agree that no equipment, exercise, or non- surgical treatment can remove fat exclusively from a single area of the body. The amount of fat in the body is determined by the individual’s eating and exercise habits, but the distribution of fat in the body is determined by heredity. In most cases, reduction of a particular part can be accomplished only as part of an overall weight reduction program. The one exception to this is liposuc- tion, a surgical procedure that may be helpful in some cases. During this procedure, fat is sucked out through a small hollow tube inserted into the fatty area. Propo- nents state that it can remove 6 pounds of fat with little or no scarring. However, complications have included postoperative pain, perforation of internal organs, and fat embolism.86 Loss of skin elasticity limits the degree of improvement in older patients.
Gadgets and Gimmicks Over the years, hundreds of bogus gadgets and gimmicks have been marketed with claims that they act in some special way to produce weight control or to slim various parts of the body. For example:
The Vision Dieter was a two-toned pair of eyeglasses claimed to control appetite if worn 2 hours a day. Its inventor rea- soned that if colors could induce shoppers to buy certain products in supermarkets, they also could produce an op- posite effect that would reduce food consumption.
Slim‑Skins, a plastic suit with an attached hose, was alleged to slim the body if connected to a vacuum cleaner during exercise.
Astro‑Trimmer and various other belts or waistbands have been falsely claimed to reduce one’s waistline by applying pressure or producing extra heat loss.
Subliminal tapes have been falsely claimed to produce weight loss by reprogramming the brain.
figure 12-2. Local newspaper advertisement.
become a certified
body wrapologist for information call 258-0252
Clues to Fraud83
The FTC advises skepticism toward weight-loss products or programs that are promoted with words or phrases like:
breakthrough ancient easy exclusive effortless exotic guaranteed mysterious magical new discovery miraculous secret
√ Consumer Tip
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“Diet candies” have been promoted with claims that eating some before meals will cause a rise in blood sugar that will decrease appetite. However, they accomplish neither of these things.
“Walk-on-air” shoes, made of plastic and lined with springs, were claimed to make people move faster, feel better, and burn more calories.
“Slimming soles” are said to stimulate specific reflexology points on the feet. When slipped into a person’s shoes, they allegedly cause automatic weight loss (“over 15 lbs in 6 weeks”) with every step the person takes.
A machine was said to help dieters by counting the number of bites of food and sounding a bell to announce when the user had eaten enough.
Earrings and earpieces have been claimed to curb appetite through pressure on “acupuncture points” located on the ear.
Rubber pellets said to resemble maggots were to be wet and sprinkled over a forbidden food. The wriggling motion they develop was claimed to make the user want to avoid the food.
A crossbar contraption that would enable users to hang upside down was claimed to cause calories to rush to the brain where they cannot be absorbed by the intestines.
A blue velour blanket was claimed to melt fat during sleep if wrapped around the body after the user took a shower and drank lemon water.
Bandaids moistened with homeopathic drops have been claimed to suppress appetite when applied to “acupuncture points” on the wrists.
As far-fetched as some of these items may seem, they still may attract large numbers of buyers who are desperate or gullible enough to try almost anything.
federal trade CoMMission aCtions
Many weight-loss programs are marketed through direct mail, TV infomercials, newspaper and magazine adver- tising, and the Internet. Products typically are claimed to “neutralize food calories,” “melt fat off without hunger,” and cause weight loss of 10 to 20 pounds in the first week. The programs usually consist of one or more tablets or capsules plus a low-calorie diet, which is usually high in protein. Following the diet may result in modest weight loss, but the ads are worded to suggest that the pill is the key to the program. Over the years, the FTC has taken more than 150 regulatory actions against marketers who made false or unsubstantiated claims about weight-control products. Some sellers that offered “free” trials (with a small charge for shipping) or a money-back guarantee not only
Historical Perspective
Herbalife’s Checkered History Herbalife International is a multilevel marketing company that was founded in 1980. Its diet plan was based on four products: (1) a powdered protein meal substitute, (2) an herbal blend with ingredients that include small amounts of laxatives, (3) a multivitamin/multimineral/herb formula, and (4) a linseed oil formula. Initially these products and others were marketed with suggestions that they would produce rapid weight loss and that the herbs they contain were effective against many serious diseases. Testimonials to this effect were spread by personal contact and frequent television specials. In 1982 the FDA sent Herbalife a Notice of Adverse Findings, which stated that certain products were mis- branded by claims that they were effective for treating many diseases, dissolving and removing tumors, reju- venating the body, increasing circulation, and producing mental alertness. In 1985 a U.S. Senate subcommittee held hearings at which experts testified that Herbalife had made many false claims, and company officials admitted that many users had experienced headaches, diarrhea, constipation, or other adverse effects from its products.87 Soon afterward, the California Attorney General charged that Herbalife had made false claims for many of its
products and engaged in an illegal pyramid-style market- ing scheme. In 1986 the company and its president, Mark Hughes, agreed to pay $850,000 to settle these charges. The court order settling the case forbids representation without reasonable basis that Herbalife products contain herbs that can curb appetite, burn off calories, or cleanse the system. In 2000, after a 4-day drinking binge, Hughes died of an overdose of alcohol and a toxic level of the antidepres- sant doxepin. His blood alcohol level was 0.21%, which is more than twice the legal limit for driving a car.88
Herbalife’s current weight-management program, called “Shapeworks,” includes some ingredients that differ from the company’s original program. Although Herbalife’s literature no longer contains false disease- related claims, its products are still hyped. For example, many distributor Web sites describe its “Total Control” as an “herbal enhancer that works at the cellular level to promote weight loss. Herbalife’s programs are promoted with lots of “success stories,” but the few scientific studies that have been reported do not demonstrate effectiveness. In 2007 more than 20 cases of severe liver toxicity associated with Herbalife product use were reported.89,90
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Historical Perspective
The Rise and Fall of Cal‑Ban 3000 One of the prominent weight-loss scams during the late 1980s was Cal‑Ban 3000, a guar gum product claimed to virtually eliminate fat by “short-circuiting the fat- building process.” Its marketing began in 1986 and lasted 4 years despite regulatory action by the Postal Service and the Iowa Attorney General. Guar gum is a soluble fiber used in small amounts as a thickener in sauces, desserts, syrups, and various other foods. It has some medically recognized value as a bulk laxative, a cholesterol-lowering agent, and an adjunct to controlling blood-sugar levels in certain diabetics. But it has not been proven effective for weight control; no long- term controlled test of guar gum as a weight-control agent has been reported in the scientific literature. Although
weight loss was reported among individuals who took guar gum during studies related to cholesterol and blood-sugar control, this finding was not consistent. Cal‑Ban 3000 was widely promoted through ads showing before-and-after pictures of obese individuals who said they had lost large amounts of weight. Sales were estimated to be $10 to $20 million per year. By 1990 the FDA was aware of complaints involving more than 100 people, at least 50 of whom needed medical intervention. The complaints included nausea; vomiting; and obstruc- tion of the esophagus, stomach, and upper and lower intestine.91 During the summer of 1990 state, local, and federal agencies conducted seizures and obtained injunc- tions that drove the manufacturer out of business.92
failed to give refunds but also made unauthorized credit card charges. Here are some examples: In 1994, the FTC charged that Ronald A. Gorayeb and his companies had made unsubstantiated claims for $39.95 group-hypnosis seminars held throughout the United States. One advertisement claimed that Gorayeb Weight-Loss Seminar participants could expect “results ranging from 30–60 lbs. in three months to 120 lbs. in a year” without willpower, hunger, or dieting. The case was settled with a consent agreement banning unsub- stantiated claims that the sessions were effective. In 2004, the FTC charged the marketers of CortiSlim and CortiStress with making false and unsubstanti- ated claims.93 The claims were made primarily through 30-minute infomercials that falsely alleged that persis- tently elevated levels of cortisol, the “stress hormone,” are the underlying cause of obesity and that CortiSlim causes substantial weight loss by controlling cortisol levels. The FTC objected to claims that CortiSlim: (a) causes weight loss of 10 to 50 pounds for virtually all users; (b) causes users to lose as much as 4 to 10 pounds per week over multiple weeks; (c) causes users to lose weight specifically from the abdomen, stomach, and thighs; (d) causes rapid and substantial weight loss; and (e) causes long-term or permanent weight loss. The FTC also objected to the claim that more than 15 years of research have demonstrated that CortiSlim and its ingre- dients are effective. In 2005, California-based Pinnacle Marketing Concepts, Inc. and its president, Thomas F. Cheng, and Utah-based Shawn M. Talbott, Ph.D., signed a consent agreement to pay a total of $4.5 million in cash
and other assets and to refrain from making unsubstanti- ated claims for any health-related product in the future.94
In 2006, Dennis Gay, Daniel B. Mowrey, Mitchell K. Friedlander, and six companies under which the trio had done business, settled FTC charges related to weight loss claims. The FTC objected to representations that (a) their skin gels melted away fat wherever applied, including a user’s thighs, tummy, and even a double chin; (b) two ephedrine pills—Leptoprin and Anorex—would cause weight loss of more than 20 pounds; (c) PediaLean fiber pills would cause overweight children to have substantial weight loss; (d) clinical testing proved these claims; and (e) their spokesperson was a medical doctor. The settle- ment included a $3 million payment and a ban on future unsubstantiated claims.95
In 2010, at the FTC’s request, a U.S. district court ordered Arizona-based Central Coast Nutraceuticals, Inc. (CCN) and its owners to temporarily halt a scheme that allegedly scammed consumers out of at least $30 million in 2009 alone through deceptive advertising and unfair billing practices. Since 2007, victimized consum- ers have made more than 2800 complaints to enforce- ment agencies and the Better Business Bureau. The FTC charged CCN’s owners and four related companies with deceptively advertising AcaiPure (an acai berry supple- ment) as a weight-loss product and ColoPure (a “colon cleansing” product) as an aid for preventing cancer. The defendants were also charged with deceiving prospective buyers by offering “free” or “risk-free” trial offers that opened the door to unauthorized credit card charges. The court order imposed a temporary asset freeze.96
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At a press conference announcing the FTC action, a VISA official stated that his company took aggressive action after the number of complaints from dissatisfied customers mounted. Under VISA’s regulatory program, when requests for chargebacks (forced refunds) reach 1% of sales, sellers are pressured to modify their sales practices, but the CCN case was complicated because the company changed names several times. Another VISA representative told Dr. Stephen Barrett that more than half the companies that generate excessive chargebacks sell dietary supplements, but VISA’s regulatory activity is focused on sales practices rather than product claims. In 2002, after surveying more than 300 ads, the FTC staff97 concluded:
The use of false or misleading claims in weight-loss advertis- ing is rampant. Nearly 40% of the ads in our sample made at least one representation that almost certainly is false and 55% of the ads made at least one representation that is very likely to be false or, at the very least, lacks adequate substantiation. The proliferation of such ads has proceeded in the face of, and in spite of, an unprecedented level of FTC enforcement activity, including the filing of more than 80 cases during the last decade.
The report also listed claims for nonprescription drugs, dietary supplements, creams, wraps, devices, or patches that an expert panel identified as fraudulent (“red flags”) because they were not scientifically feasible:
• Causes weight loss of 2 pounds or more a week for a month or more without dieting or exercise.
• Causes substantial weight loss, no matter what or how much the consumer eats.
• Causes permanent weight loss (even when the consumer stops using the product).
• Blocks the absorption of fat or calories to enable consumers to lose substantial weight.
• Safely enables consumers to lose more than 3 pounds per week for more than 4 weeks.
• Causes substantial weight loss for all users. • Causes substantial weight loss by wearing it on the body
or rubbing it into the skin.
The FTC then urged media outlets to use these “red flags” to screen out ads with obviously false claims. In 2004, a follow-up survey98 found that the percentage of ads containing at least one red flag claim had dropped from 49% to 15%, but the FTC cautioned that many misleading ads remained and weight-control ads without a red-flag claim could still be misleading. Many media officials claim they lack the time and expertise to screen out bad ads. But because the red flag guidelines require very little effort to apply, failure to use them is inexcusable.
Weight-Control organizations
Many organizations have been established to provide both individual and group counseling for people seek- ing to lose weight. Some organizations are nonprofit and relatively inexpensive, whereas others are quite costly. Many hospitals and universities conduct obesity clinics. Several self-help organizations have chapters in many cities. Few well-designed scientific reports have been pub- lished about the effectiveness and complication rates of the methods described in this section.
Inexpensive Programs TOPS (Take Off Pounds Sensibly) was started in 1948 and has nearly 10,000 chapters and about 170,000 mem- bers worldwide. The members must submit weight goals and a diet from a health professional in writing. Each group elects a nonprofessional volunteer to direct and organize its activities for 1 year. The weekly meetings include a confidential weigh-in and offer moral support, with awards for lifestyle changes and special recogni- tion for the best losers. The cost is $26 per year plus a nominal fee for weekly meetings. Weight Watchers is a franchise started in the 1960s that now includes diet, behavior modification, and exer- cise. Over 1 million members attend more than 20,000 weekly meetings worldwide. The program focuses on changing one’s eating habits rather than counting calo- ries. It attempts to help overweight people to cope with the problems that made them fat and to alter their eating habits. It costs about $20 to join and about $10 per week for meetings. Lifetime members who have completed a maintenance plan and remain within 2 pounds of their weight goal can attend monthly meetings for free. Overeaters Anonymous (OA), founded in 1960, is a nonprofit fellowship for individuals who define themselves as compulsive overeaters. It has about 6500 groups worldwide. It operates on the premise that overeating is a progressive illness that cannot be cured but can be arrested. It has a religious basis but is not affiliated with specific religious institutions. OA encourages its members to seek professional help for an individualized diet/nutrition plan and for any emotional or physical problems. Members attend weekly meetings when needed. They follow a 12-step plan similar to that of Alcoholics Anonymous. There are no dues or fees.
Expensive Programs Thousands of commercial obesity clinics and centers are operating in the United States, most of them franchised
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by large national organizations. Advertisements for these facilities typically promise considerable weight loss and include before-and-after pictures of clients who supposedly have accomplished this. Programs are said to be medically supervised, but the degree of supervision varies. Many clinics are administered by registered nurses. Many employ a physician to do an initial physical examination, but the client might not see the physician again. Prepackaged foods, drinks, or supplement mixtures may be used instead of all or just some meals. Some diets are balanced, whereas others cause ketosis. Fees commonly range from $25 to $75 per week, depending on the program and whether special products are purchased. In several parts of the country, dietitians who have inquired at various clinics have encountered incorrect nutrition concepts and misleading claims for many of these programs.
Evaluations The NIH Technology Conference panel99 on weight-loss methods concluded that information about program success should include the percentage of beginning participants who complete the program; the percentage of those who achieve various degrees of weight loss; the proportion of weight loss retained after 1, 3, and 5 years; and data on adverse medical or psychologic effects the participants experience. A subsequent NIH obesity task force8 issued five consumer guidelines for choosing a program:
1. The diet should be safe and include all of the Recommended Dietary Allowances for vitamins, minerals, and protein.
2. The program should be directed toward a slow, steady weight loss unless a more rapid loss is medically indi- cated.
3. A doctor should evaluate health status if the client’s weight goal is greater than 15 to 20 pounds, if the client has any health problems, or if the client takes medication on a regular basis.
4. The program should include plans for weight maintenance.
5. Prospective clients should receive a detailed list of all fees and costs.
A study of 31 people whose photograph and testi- monial had appeared in newspaper ads for a weight-loss clinic found that 20 months later, only eight (26%) had remained within 5 pounds of their target weight. The clinic, a Midwestern affiliate of a national commercial weight-loss program, offered behavioral education with a prepackaged food regimen. The researchers added that
their data should be interpreted cautiously because their findings did not reflect the experience of clients who never met their weight-loss goals.101
In 2003, Tsai and Wadden102 evaluated the Web sites and reported results of Weight Watchers, Jenny Craig, Health Management Resources, OPTIFAST, Medfast/ Take Shape for Life, eDiets.com, TOPS, and Overeat- ers Anonymous. The researchers concluded: “With the exception of 1 trial of Weight Watchers, the evidence to support the use of the major commercial and self-help weight loss programs is suboptimal.” They also ex- pressed concern that because drop-out rates were high, some of the published studies are probably a best-case scenario.
Low-Calorie Disaster100
In 1990 Carol Householder of Flagstaff, Arizona, testi- fied to a Congressional subcommittee on behalf of her husband, Michael, who had a doctoral degree and had been a college engineering professor. In 1985, at age 44, Michael was 6 feet tall and weighed 215 pounds. Having gained 30 pounds during the previous 5 years, he wanted to weigh approximately 180. He considered himself to be in good physical condition. He had biked, jogged, swum, played racquetball, skied, and, earlier that summer, had hiked the Grand Canyon rim to rim (25 miles). Having seen ads stating that the Nutri/Sys- tem diet succeeds where other diets fail, he joined the Nutri/System program and followed its 1000-calorie- per-day diet. In about 7 weeks, he lost approximately 28 pounds. A few days later, after jogging, he passed out for a minute or two. He discussed this with his Nutri/ System adviser, who said he should eat more fruit. A week later, only 1 pound short of his goal, he suffered a cardiac arrest while returning from a jog. Although resuscitated by paramedics, he remained in a coma, hooked to life support systems, for the following 70 hours. His attending physician said that the cardiac arrest had been triggered by potassium deficiency and borderline protein deficiency. When Michael awakened, both his long- and short-term memory had been erased. He didn’t know his name. He couldn’t recognize his family, and it took months for him to begin over again. He was just a frac- tion of his former self, permanently unable to work and requiring supervision of all daily activities. In order to take care of him and their three children, Carol was forced to leave her job.
Personal Glimpse
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Government Investigations During 1990 a U.S. House of Representatives sub- committee, chaired by Rep. Ron Wyden (D-OR), held two hearings focused on deception and fraud in the diet industry.100 Testimony indicated that some commercial programs referred to their staff as “certified” nutrition counselors, behavior therapists, and the like, even though the only certification they had was by the company offering the program. One woman described how her husband had suffered a cardiac arrest as a result of a poorly supervised program (see Personal Glimpse box on page 253). During the mid-1990s the FTC settled enforcement actions against Diet Center, Jenny Craig International, Nutri/System, Physicians Weight Loss Centers, Weight Watchers International, and 13 other marketers of com- mercial weight-loss programs after charging them with (a) making deceptive and unsubstantiated claims about their results, (b) failing to fully disclose costs, and/or (c) using testimonials that did not reflect the typical user’s experience. The settlements included four requirements:
1. Claims that a specified weight loss is typical must be based on a sample of all patients who have entered the program (or another clearly identified segment of patients).
2. Claims that weight loss is long-term must be based on
sound studies that cover at least 2 years after completion of a weight-loss and maintenance program.
3. Claims of permanence must be based on a period of time recognized by experts or demonstrated by reliable survey evidence as sufficient.
4. Claims of successful maintenance must include disclosures of average weight loss and the length it was maintained, as well as the statement: “For many dieters, weight loss is only temporary.”
suggestions for Weight Control
Medical and nutrition scientists agree that the key to weight control is to establish prudent and permanent habits of exercise and control of calorie intake. For ini- tial weight loss, they recommend a well-balanced diet with few enough calories to produce a steady loss of 1 to 2 pounds per week. The minimum caloric level for unsupervised dieting should be 1200 to 1300 calories, per day, which is enough to be able to supply adequate amounts of the essential nutrients. If food selection is done properly at this caloric level, vitamin supplements are unnecessary. The maximum caloric amount to start with should depend on the individual’s height and ac- tivity level. Once desirable weight is achieved, caloric intake can be increased to maintain it.
Activity 105–115 lbs 127–137 lbs 160–170 lbs 182–192 lbs
Golfing, hand cart 3.25 3.75 4.41 4.91 Baseball, fielder 3.66 4.16 4.91 5.41 Walking, 3 mph 3.90 4.50 5.23 5.80 Hiking, 20 lb pack, 2 mph 3.91 4.50 5.25 5.83 Rowing machine, easy 3.91 4.50 5.25 5.83 Swimming, crawl, 20 yd/min 3.91 4.50 5.25 5.83 Badminton, singles 4.58 5.16 6.16 6.75 Skating, leisurely 4.58 5.16 6.16 6.75 Calisthenics 3.91 4.50 7.33 7.91 Bicycling, 10 mph 5.41 6.16 7.33 7.85 Tennis, doubles 5.58 6.33 7.50 8.25 Aerobic dancing 5.83 6.58 7.83 8.58 Basketball, half-court 7.25 8.25 9.75 10.75 Handball 7.83 8.91 10.50 11.58 Volleyball 7.83 8.91 10.50 11.58 Jogging, 5 mph 8.58 9.75 11.50 12.66 Running, 6.5 mph 8.90 10.20 12.00 13.20 Skiing cross-country, 5 mph 9.16 10.41 12.25 13.33 Bicycling, stationary, 20 mph 11.66 13.25 15.58 17.16
CaloriC expenditure per Minute for various aCtivities and BodY Weights
Table 12-6
Modified from Perry P. Are we having fun yet? American Health 6(2):59-63, 1987.
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Weight Watchers International wants America’s buzz- words to reflect a more reasonable way of thinking about how a healthy lifestyle can be achieved:
“What’s In” “What’s Out” Weight management Weight loss Long-term weight loss Weight cycling Moderation Deprivation Healthful eating Diets Portion control Calorie counting Healthy weight range “Ideal” weight Self-acceptance Self-condemnation Increased physical activity “No-pain, no-gain” Support systems “Going it alone” Balanced food plan Liquid diets/pills High-carbohydrate diet High-protein diet Reading food labels Ignoring contents Small changes Radical weight loss Behavior modification Uneducated change Healthy snacking No eating between meals
suggested “neW lifestYle language” Table 12–7
Source: Weight Watchers International press release, Dec 27, 1993.
Exercise Exercise plays a very important role in weight control. The idea that exercise is self-defeating is a myth. In most cases exercise does not increase appetite unduly. Most research on humans indicates that food intake (a) does not change with moderate exercise of extended duration and (b) decreases slightly with vigorous exer- cise of short duration.103
Consumer Reports on Health104 suggests that people wishing to lose 10 pounds or less might do best by in- creasing exercise without dieting. The number of calories typically burned per hour by a 150-pound person is about 100 at rest; 200–300 during household chores or walking leisurely; 300–600 during recreational athletic activities, and 600–900 during strenuous athletics (Table 12-6). Consumer Health Sourcebook (www.chsourcebook. com) has a table that lists the level for 85 activities. Chapter 13 contains additional information on exercise and weight control. Behavior Modification Successful weight control requires a permanent change in habits rather than a temporary change (such as a diet) that one adheres to until a desired weight level is reached. Various modification procedures are aimed at helping the overfat individuals change their patterns of inappropriate food consumption such as overeating, eating high-calorie foods, or snacking between meals. Those who overeat in response to tension may require psychotherapy as well. In many cases other members of the obese individual’s household will have to modify behavior that stimulates overeating. Foreyt and Goodrick105 identified these methods as useful:
seLf-MonitorinG: Self-observing and recording of situational factors, thoughts, and feelings that occur before, during, and after attempting to eat and exercise prudently. Self-review enables tracking of progress. Scrutiny by a therapist may enhance self-control.
stiMuLus controL: Modification of factors that stimulate inap- propriate eating or exercise behavior.
GraDuateD tarGet Behaviors: Gradual dietary change to avoid feelings of deprivation; gradual development of cardiorespiratory fitness to avoid the perception of exercise as punishment.
continGency ManaGeMent: Use of a signed contract specifying what the patient will do and the rewards for doing it.
coGnitive-BehavioraL strateGies: Movement from self-rejec- tion to self-acceptance; focusing on ways in which thoughts, moods, diets, and social pressures affect eating control.
Weight Watchers International has suggested chang- ing the buzzwords used to encourage a healthy lifestyle (Table 12-7).
Stare, Aronson, and Barrett106 have offered the fol- lowing tips for achieving calorie reduction:
• Use alternatives to food as rewards (for example, long walks, relaxing baths, tickets to a movie or play).
• Find nonfood outlets for release of emotional tension. • Resist the temptation to always “clean the plate.” • If you eat moderate portions of your favorite foods, you
will be less apt to crave them and overindulge. • Do not eat while doing anything else, such as talking on
the phone or watching television.
Aaron Altschul, Ph.D., of the Georgetown University Clinic, has concluded that successful dieters:
• Know their weight; they weigh themselves often enough that they are never in doubt about where they stand in rela- tion to their goal.
• Use a personally suitable diet plan—one that they can enjoy or tolerate permanently.
• Know what they are eating; if necessary, they keep daily records until they automatically know what they are eat- ing every day, can anticipate heavy eating events, and can adjust their intake accordingly.
• Control their alcohol intake. • Engage in a regular program of exercise.
Researchers at the Pennsylvania State University have demonstrated that larger portion sizes may induce
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people to eat more. The study involved 51 adults who —once a week for four weeks—were served lunch that included either 500, 625, 750, or 1000 g of macaroni. Some received the portion on a plate, and some received it in a serving dish and served themselves. The subjects consumed more when offered the largest portion than when offered the smallest portion. The researchers con- cluded: (a) larger portions led to greater consumption regardless of serving method and (b) portion size may be relevant to the prevention and treatment of obesity.107
In 2002 Consumer Reports108 tabulated the results of a survey that drew 32,213 responses from readers who said that they had tried to lose weight during the previous 3 years. Nearly 25% said they had managed to lose at least 10% of their starting weight and keep it off for a year. The most common strategies they used were (a) exercising at least 3 times per week, (b) increasing physical activity into daily routines (e.g., using stairs instead of elevator), (c) reducing amount of food per meal, and (d) eating fewer fatty foods.
suMMarY
To lose weight, people must eat less, exercise more, or do both. Although hundreds of “miracle” products and “revolutionary” diets have been marketed, no pill, potion, or dietary plan can produce weight loss without exercise or lowering of caloric intake. To lose 1 pound of fat, it is necessary to burn 3500 more calories than are consumed. Professional help may be required to clarify and modify the behavior that contributes to overeating. The most sensible weight-loss methods aim for a steady reduction of about 1 pound a week. The diet that experts recommend most often is a balanced, low- calorie, low-fat food plan that is easily adapted for long- term maintenance. Although unbalanced diets can cause weight loss, they are usually too monotonous for long- term use and are followed by weight gain when the user returns to “normal” eating. Repeated dieting followed by weight gain (“yo-yo dieting”) may increase the risk of premature death from heart disease and several other diseases, but the research on this is not conclusive. Many people diet even though they are not over- weight. The majority of people concerned about their weight would probably do better to focus on exercise, healthful eating, and minimizing cardiovascular risk factors rather than on counting calories.
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70. Cunningham JJ. DHEA: Facts vs hype. Nutrition Forum 2:30, 1985.
71. Lijesin GKS and others. The effect of human chorionic go- nadotropin (HCG) in the treatment of obesity by means of the Simeons therapy: A criteria-based meta-analysis. British Journal of Pharmacology 40:237–243, 1995.
72. Allred J. Too much of a good thing? An overemphasis on eating low-fat foods may be contributing to the alarming increase of overweight among US adults. Journal of the American Dietetic Association 95:417–418, 1995.
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91. Lewis JH. Esophageal and small bowel obstruction from guar gum-containing “diet pills”: Analysis of 26 cases reported to the Food and Drug Administration. American Journal of Gas- troenterology 87:1424–1428, 1992.
92. Barrett S. The rise and fall of Cal-Ban 3000. Nutrition Today 25(6):24–28, 1990.
93. FTC targets products claiming to affect the stress hormone cortisol. FTC news release, Oct 12, 2004.
94. Three CortiSlim defendants to give up $4.5 million in cash and other assets: FTC’s litigation continues against four remaining defendants. FTC news release, Sept 21, 2005.
95. Major weight-loss marketers pay $3 million: FTC charged they could not back up claims for six weight-loss products for adults and kids. FTC news release, May 11, 2006.
96. Court orders Internet marketers of acai berry weight-loss pills and “colon cleansers” to stop deceptive advertising and unfair billing practices: Ads feature phony endorsements attributed to Oprah Winfrey, Rachael Ray. FTC news release, Aug 16, 2010.
97. Cleland R and others. Weight-loss advertising: An analysis of current trends. Washington, D.C., 2002, Federal Trade Com- mission.
98. FTC releases result of weight-loss advertising survey: While media screening of fraudulent ads seems to be working, more work is needed, FTC reports. FTC news release, April 11, 2005.
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101. Fatis M and others. Following up on a commercial weight loss program: Do the pounds stay off after your picture has been in the newspaper? Journal of the American Dietetic Association 89:547–548, 1989.
102. Tsai AG, Wadden TA. An evaluation of major commercial weight loss clinic programs in the United States. Annals of Internal Medicine 142:56–66, 2005.
103. Franklin BA, Rubenfire M. Losing weight through exercise. JAMA 244:377–379, 1980.
104. Diet vs. exercise: What’s best? Consumer Reports on Health 4:1–3, 1992.
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82. Post-bariatric body contouring patients face increased risks to safety, says AAAPS. American Association for Aesthetic Plastic Surgery news release, Nov 1, 2004.
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90. Elinav E and others. Association between consumption of Herbalife nutritional supplements and acute hepatotoxicity. Journal of Hepatology 47:514-520, 2007.
Fitness ConCepts, produCts, and
serviCes
An ideal exercise would improve your aerobic fitness, burn excess body fat, add to muscular strength and endurance, and be easy to start and sustain. However, there is no ideal exercise—at least not for everyone. So aim for a program that helps you accomplish your goals without boredom or guilt.
Consumer reports on HealtH1
It’s best to go slow as you consider taking the plunge into home exercise equipment. For every exercise bike or rowing machine that’s used regularly in a basement or bedroom, another is gather- ing dust.
Consumer reports2
© medical economics, 1981
“He can’t come to the phone right now—he’s pumping iron!”
Chapter Thirteen
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Exercise, as defined in this chapter, is the planned, structured, repetitive physical activity done to achieve physical fitness and other specific goals.
Physical fitness is the ability to carry out daily activi- ties without undue fatigue and with ample energy left to enjoy leisure‑time pursuits and meet the physical demands of emergencies. Performance‑related fitness (which includes speed, power, balance, coordination, and agility) may enhance life in many ways and can contribute to longevity. But health benefits occur with even modest levels of physical activity. Although the principles of exercise physiology are well‑developed, many people promote unscientific regimens, and many consumers waste money on prod- ucts and services that have no value. Safety should also be an important consideration. This chapter elucidates the role of exercise in health and fitness and provides guidelines for choosing programs, facilities, equipment, and services. It also discusses products promoted for bodybuilding and athletic performance enhancement (often called “ergogenic aids”) and the dangers of ana- bolic steroids.
publiC perCeptions
People today generally accept the idea that exercise is good for their health, but this was not always so. Hippocrates, whose writings influenced medical think- ing for more than 2000 years, considered the health of athletes precarious:
In the case of athletes too good a condition of health is treach- erous if it be an extreme state; for it cannot quietly stay as it is, and therefore, since it cannot change for the better, can only change for the worse. For this reason it is well to lose no time in putting an end to such a good condition of health, so that the body can start again to reconstitute itself.3
The ancient Greeks knew that extreme exertion was hazardous. According to ancient legend, Philippides ran from the battlefield at Marathon to Athens, announced “rejoice, we conquer,” and fell dead. Although many people perceive the ability to run a marathon as a sign of superhealth, this idea is part of folklore about strenuous exercise. In early America, common experience did not suggest that athletic prowess and good health were equivalent. Sports events were staged for entertainment, to provide opportunities for gambling, and to promote nationalism. Feats of strength by “muscle‑men,” 6‑day bicycle races, 24‑hour walking contests, dance mara- thons, and boxing matches with unlimited rounds were excesses with questionable health benefits. Early advo- cates of healthful living promoted exercise as desirable, but they emphasized posture; calisthenics (then called “gymnastics”); and relatively useless practices such as taking deep breaths, waving wands, and tossing Indian clubs and medicine balls. The need for exercise became a social concern after thousands of young men were rejected as physically unfit for military duty in World War I. This led to the introduction of physical training activities for the general public and in the schools. In the 1920s, as the science of exercise physiology developed, school programs were called “physical education.” The popularity of sporting events led educators to incorporate athletic activities into physical education, using them to foster physical development, sportsmanship, and fair play. The 1950s were pivotal to the public perception of exercise and health. Tests during the early part of this decade revealed that American children were not as fit as European children. Findings like these led President Dwight D. Eisenhower to convene experts to propose ways to improve America’s fitness level. President John
• Regular physical activity can help improve the way people look, feel, and work and can increase longevity.
• Most people can benefit from regular aerobic exercise and strength training. However, health benefits occur even with modest amounts of physical activity.
• The keys to sustaining a fitness program are to (a) choose activities you like doing and (b) take precautions to prevent injury.
• A good personal exercise program need not be expensive to maintain. Before investing in exercise equipment, be sure it is something you like using and will continue to use.
• Before signing a contract with a health or fitness club, be sure to understand all costs and cancellation terms.
• Most products promoted as “ergogenic aids” are a waste of money, and a few are dangerous.
Keep these points in Mind as You studY this Chapter
Key Concepts
Chapter Thirteen Fitness Concepts, Products, and Services 261
F. Kennedy subsequently established the Office of Sports and Fitness (now the President’s Council on Fitness, Sports & Nutrition) in Washington, D.C. The Council’s Web site (www.adultfitnesstest.org) has interactive tools that can help people evaluate their fitness level. In the late 1960s cardiologist Kenneth Cooper, M.D., wrote Aerobics, a popular book that outlined fitness programs for adults and stressed heart‑lung efficiency. As awareness of the importance of physical fitness in- creased, physical education became more closely related to all‑around fitness and health. In the late 1970s mara- thon runner Jim Fixx’s The Complete Book of Running became a bestseller and fueled a growing interest in jogging and long‑distance running. Thomas Bassler, M.D., president of the Ameri- can Medical Joggers Association, had speculated that marathon running may confer immunity from coronary
artery disease. This hypothesis was refuted in cardiol- ogy journals as autopsies provided contrary evidence. However, the idea that marathon runners were not “su- permen” immune to heart disease did not hit home with the public until 1984 when Fixx, age 52, died suddenly during a 10‑mile run. Fixx’s father had had his first heart attack at age 35 and had died at age 42.5 Jim Fixx’s death dramatized the fact that a high degree of fitness may not overcome a strong heredity tendency toward coronary disease. (On the other hand, risk‑factor modification as described in Chapter 15 is still very important because some hereditary factors are modifiable.) The most com- mon cause of sudden death among competitive athletes is hypertrophic cardiomyopathy, a heart‑muscle disease that is not related to coronary heart disease and is difficult to detect.6
In recent years there has been a surge of interest in strength training with weights and bodybuilding ma- chines. Magazine racks in some stores have entire sec- tions devoted to sports, fitness, and body improvement.
beneFits oF exerCise
Exercise offers many benefits. It can increase stamina and endurance, lower blood pressure, improve blood cholesterol levels, help with weight control, help lower abnormal blood sugar levels, reduce stress, improve sleep, decrease the incidence of certain cancers, and help prevent osteoporosis and hip fractures. Exercise can also prolong life. The Framingham Study, which has followed more than 5000 residents of Framingham, Massachusetts, since 1948, has quantified how exercise delays the onset of cardiovascular disease and increases overall longevity. In 2005, the researchers announced that among people age 50 or more, those with higher physical activity levels lived about 3.6 years longer and were free of cardiovas- cular disease 3.3 years longer than those who maintained a low physical activity level and that moderate exercisers lived about 1.4 years longer and were cardiovascular disease‑free about 1.2 years longer than low‑level exer- cisers.7 Figure 13‑1 illustrates how the risk of premature death declines as physical activity increases. The main reason most people exercise is not to prevent disease but to feel more alert and energetic. Many exercise regularly because they feel it benefits their emotional state and makes them look better. Young men generally wish to build up their muscles and gain weight, whereas young women are more likely to want to lose weight “in the right places.” Many people maintain a fitness level that enables them to enjoy recreational sports that can also serve as a social outlet.
Personal Glimpse
A Demonstration of Great Strength In 1912 Bernarr Macfadden toured Midwestern cities to spark interest in his courses in “physical culture.” One of the muscular youths who accompanied him was 18‑year‑old Forrest C. Shaklee, who became a chiro- practor and later founded the Shaklee Corporation, a large company that markets “natural” products through person‑to‑person sales. Shaklee literature describes how young Forrest helped Macfadden’s promotion:
Parades were held on the main street of each town, and consisted of a pride of muscular youths, some musicians, and a flatbed wagon. . . . When enough of a crowd had been gathered around the flatbed, each of the youths was to exercise with a given piece of equipment. This was preceded by a discourse from Macfadden, extolling health through nature, diet and especially non‑diet (he tended to look upon fasting as a blanket cure‑all) and, of course, strenu- ous exercise . . . . The pièce de résistance of these outdoor displays was the lifting of an iron ball which appeared to weigh easily 500 pounds. Secured to the ball was a massive link chain, which one of the youths would grasp and which, with much concentration and ap- parent straining, he would raise gradually over his head. The crowds watching in awed silence at the beginning of the feat, would break into cheers and applause when the ball was finally raised. When it was his turn at the ball, Forrest discovered that lifting it was easily accomplished; the ball was hollow!4
Part Three Nutrition and Fitness262
Exercise can also have psychologic value. Stress‑ management programs commonly employ exercise as a way to cope with the effects of stress. Some psychothera- pists recommend it for the same reason. Looking fit can enhance self‑image, which can help people feel better about themselves. Many people who pursue bodybuild- ing take special pride in their appearance.
tYpes oF exerCise
Exercise can be classified as anaerobic, aerobic, isomet- ric, isotonic, and isokinetic. As exercise becomes more vigorous, the respiratory rate increases, the lungs trans- mit more oxygen to the bloodstream, and the heart pumps harder and faster to convey the oxygen to the muscles. Anaerobic exercise is so intense that respiration cannot supply all of the oxygen the body needs. The resultant “oxygen debt” permits lactic acid to build up in the muscles, impairing muscular activity until sufficient oxygen is available for recovery. (The word “anaerobic” means “without oxygen.”) In high‑intensity events, such as the 100‑yard dash, most of the energy is supplied anaerobically. Aerobic exercise is prolonged effort during which nearly all of the oxygen needed is supplied through breathing. Aerobic training promotes heart‑lung efficiency and raises the anaerobic threshold (the activity level at which the body goes into oxygen debt). Isometric exercise refers to muscle contractions ex- erted against resistance in which there is no movement of body parts. Muscles may merely be tightened or may be used to push against or pull an object that does not move. Isometric exercise can help develop strength, but
only at the angles worked. Although somewhat useful for sedentary and elderly individuals, it has little value for an ongoing fitness program because it contributes nothing to cardiorespiratory fitness or flexibility. Isotonic exercise refers to the contraction of muscles against constant resistance while parts of the body move. It can build strength, flexibility, and cardiovascular endurance, depending on its intensity and duration. It occurs during calisthenics, weightlifting, swimming, walking, running, and many other athletic activities. Isotonic exercise is superior to isometrics because it develops strength throughout the entire range of motion. Isokinetic exercise employs specially designed equipment that enables pushing or pulling at constant speed through an entire range of motion. This increases the intensity of the exercise.
CoMponents oF Fitness
Muscles become stronger through use and weaker as a result of inactivity. Regular exercise can increase strength, endurance, flexibility, motor fitness, and cardiorespiratory efficiency. Strength is the amount of force that can be applied by a muscle or group of muscles with a single contraction. The best way to strengthen muscles is through exercise that involves gradually increased resistance. Muscles increase in size and develop strength in proportion to the amount of resistance during the exercise. The more resistance a person works against, the greater will be the strength gains. Endurance is the ability to use muscles repeatedly for extended periods. Endurance‑trained muscles have a better blood supply because additional capillaries de- velop as the muscles adapt. Regular exercise contributes to muscular endurance, with greater endurance occur- ring with more repetitions or longer duration. Muscular endurance activities can be done daily. Flexibility is the stability of muscles and other soft tissues that affect the range of motion of joints. In many activities it can enhance performance. Exercise folk- lore holds that weightlifting causes people to become musclebound (lacking in flexibility). Flexibility can be diminished if high‑resistance exercises are done without a full range of motion or if the exercise session does not include stretching. However, the combined strength and flexibility exhibited by well‑trained gymnasts attests to the fact that these two qualities of muscular fitness can co‑exist when training is proper. A significant degree of flexibility appears to be inherited. Flexibility is the most difficult feature of muscular fitness to improve.
Figure 13-1. How the risk of premature death declines as people become more physically active.
0 60 120 180 240 300 360 420
Minutes per week of moderate- or vigorous-intensity physical activity
1.2
1.0
0.8
0.6
0.4
0.2
0.0
R el
at iv
e ri
sk • •
•••
Chapter Thirteen Fitness Concepts, Products, and Services 263
Motor fitness refers to the ability to move quickly and efficiently. Measurable qualities are agility (the ability to change direction while in motion), speed, and coordination. Sports activities such as tennis, racquet‑ ball, squash, and dancing contribute to motor fitness. The ability to move well can help avoid accidents and enable a person to engage in enjoyable recreational activities. Cardiorespiratory efficiency is the ability of the circulatory system to deliver oxygen‑rich blood through- out the body. A circulatory system that is efficient will operate at a lower pulse rate than one that is not. A simple way to monitor exercise is to determine the heart rate by taking your pulse. To determine the ap- propriate intensity of activity, subtract your age from 220 and take 55% to 90% of the remainder for the target heart rate. Table 13‑1 lists the target zone for pulse beats and the average maximum heart rates at different ages. As fitness increases, the target pulse rate can be increased. Moderate‑intensity physical activity means working hard enough to raise your heart rate and break a sweat, yet still being able to carry on a conversation. Walking is an example. Running and jogging are examples of vigorous activity. The 2008 Physical Activity Guidelines for Ameri- cans, published by the U.S. Department of Health and Human Services (HHS), provides information and guid- ance on the types and amounts of exercise and other physical activity that provide substantial health benefits for Americans ages 6 years and older.8 This document summarizes the major research findings this way:
• Regular physical activity reduces the risk of many adverse health outcomes.
• Some physical activity is better than none. • For most health outcomes, additional benefits occur as
the amount of physical activity increases through higher intensity, greater frequency, and/or longer duration.
• Most health benefits occur with at least 2 hours and 30 min- utes (150 minutes) a week of moderate‑intensity physical activity, such as brisk walking. Additional benefits occur with more physical activity.
• Episodes of activity that are at least 10 minutes long count toward meeting the guidelines.
• Both aerobic (endurance) and muscle‑strengthening (resis- tance) physical activity are beneficial.
• Health benefits of physical activity occur for children and adolescents, young and middle‑aged adults, older adults, and those in every studied racial and ethnic group.
• Health benefits of physical activity are attainable for people with disabilities.
• The benefits of physical activity outweigh the risks of injury and heart attack.
Table 13‑2 summarizes the key recommendations.
starting an exerCise prograM
A basic exercise program will complement an indi‑ vidual’s daily routine and recreational exercise. A bal- anced program will maintain or develop the upper body (muscle groups used to move the body with the arms), legs (muscle groups used in locomotion), trunk (abdo- men and back), heart, lungs, and circulation (aerobic activity). Activities that demand high resistance do not build endurance, and low‑resistance exercises do not increase muscle strength. Sports activities develop the body unevenly. Some overemphasize the legs; others focus on the upper body. Some contribute to cardio- vascular fitness; others contribute nothing toward this important goal. People with a sedentary occupation require an exercise program that includes all aspects of physical fitness. Well‑designed exercise programs have four phases: warm‑up, cardiovascular, muscular (resistance exercise), and cool‑down. The warm‑up phase consists of mild exercise to prepare the body for more intense activity. The cardiovascular and muscular phases are the heart of the workout. The cool‑down involves activities that help the recovery process, such as walking until breathing returns to normal following intense running. When starting a program, people who have followed a relatively inactive lifestyle should consider the follow- ing guidelines:
target pulse rates For aerobiC exerCise
Table 13-1
*Maximum heart rate = 220 minus your age. †Target zone is maximum heart rate x 55% to 90%.
Age (Years)
20 25 30 35 40 45 50 55 60 65 70
Avg. Maximum Heart Rate*
200 195 190 185 180 175 170 165 160 155 150
Target Zone†
(Beats per Minute) 110–180 107–175 105–171 102–166 99–162 96–157 94–153 91–148 88–144 85–139 83–135
Part Three Nutrition and Fitness264
1. Consider whether it is advisable to consult a physician. Authorities do not agree on who should have a health assessment. However, a health examination may be appropriate for anyone who is older than 35 starting a vigorous exercise program for the first time. An examination is more appropriate for a sedentary person than for one who has been physically active. The American College of Sports Medicine (ACSM) states that asymptomatic, physically active persons of any age with no history of risk factors for coronary heart disease usually require little supervision. Whether to have exercise electrocardiography (an as- sessment of heart function while walking on a treadmill; commonly called a “stress test”) can be discussed with one’s physician. The procedure costs several hundred dollars and often yields false‑positive results that lead to further expense and more invasive testing. The American Heart Association9 recommends exercise testing for peo- ple planning to start an exercise program more intense than walking at 50% to 60% of maximum heart rate (or running or jogging) if they (a) are age 45 or older and have been sedentary, (b) have symptoms such as chest pain, (c) have a heart murmur or high blood pressure, or (d) have two or more major coronary risk factors. The Association states that men younger than 45 and women younger than 55 who have no major risk factors or signs of heart disease do not need an exercise test and should not be restricted in their exercise program. (Chapter 15 provides additional information about exercise testing.) 2. Determine the present level of fitness so that future results can be compared using the same method of determination. The ACSM Fitness Book10 provides complete information on designing an exercise program. 3. Select a type of exercise that is compatible with age and physical condition. For example:
younger tHan 30 years: With no known medical problems, the individual can participate in any type of exercise activity.
30 to 39 years: Most types of activity are suitable. However, if strenuous exercises are planned, a physician’s approval may be advisable.
40 to 59 years: It is advisable to start with a walking program. After conditioning has occurred, running, jogging, and other more demanding activities may be undertaken. However, a physician’s approval is advisable before starting. If approval is not given, less strenuous activities such as walking, golf, cycling, and swimming may be suitable.
60 years and older: The average person should avoid jog- ging, running, and vigorous competitive sports. Walking, swimming, and stationary cycling will provide benefits with less risk of injury.
4. Be prudent about the amount of exercise per- formed. Do not attempt an overly intense exercise
program. Progress gradually at the start. High‑resistance exercises should not be done more often than roughly every 36 hours—every other day is a practical guideline. Any stretching should be done after warming up. 5. Add physical activity to your daily routine. When- ever possible, for example, walk instead of riding and climb stairs instead using an elevator or escalator. 6. It is advantageous to have specific goals that can be evaluated periodically. These could include achiev- ing or maintaining a specified body weight, resting heart rate, blood pressure, or blood lipid profile or achieving a specified level on a field test (e.g., a 15‑minute run, 25 pull‑ups, 75 pounds bench‑pressed). Some experts believe that aerobics has been oversold at the expense of muscle‑building. ACSM suggests that, in addition to aerobic exercise, individuals should engage in weight training at least twice a week, performing 8 to 10 different exercises to strengthen the large muscles of the chest, arms, back, and legs. When done correctly, this can increase strength, speed, flexibility, and muscle endurance. It can also improve a person’s appearance and confidence. Many people have difficulty sustaining an exercise program. Changes in schedule (e.g., vacations, special events), illnesses, bad weather, and other interruptions can scuttle a program. The key to maintaining a healthful lifestyle is not “willpower” but motivation. People are more apt to sustain an exercise program if they exer- cise for the sake of personal appearance (bodybuilders, weight‑control enthusiasts); to maintain or improve their ability to perform at sports (avid skiers, mountain climbers, rock climbers, swimmers, tennis tournament players); to recover health (cardiac rehabilitation pa- tients, women recovering from the effects of childbirth); because their social life centers around activities which are improved by keeping fit (bowling, golf, curling, softball); or because their job description requires that they pass periodic fitness tests (firefighter, police officers, military personnel). Most sports activities alternate in intensity with bursts of energy and periods of relative inactivity. Table 13‑3 indicates how various sports activities relate to fit- ness goals. This type of information can be misleading, however. For instance, the contribution that swimming makes to cardiovascular fitness can vary greatly. Com- petitive swimmers gain cardiovascular fitness from their intense training, but recreational swimmers may not. Some people stop exercising out of boredom. Bore- dom can be prevented by careful activity selection and timing. Some people prefer certain times of the day. Some enjoy seeing the sun rise or set. Some prefer the effects of exercise in the morning, whereas others like
Chapter Thirteen Fitness Concepts, Products, and Services 265
phYsiCal aCtivitY guidelines For aMeriCans: KeY reCoMMendations8
Table 13-2
For Safe Physical Activity
• Understand the risks but be confident that physical activity is safe for almost everyone.
• Choose to do types of physical activity that are appropriate for their current fitness level and health goals, because some activities are safer than others.
• Increase physical activity gradually over time whenever more activity is necessary to meet guidelines or health goals. Inactive people should “start low and go slow” by gradually increasing how often and how long activities are done.
• Protect against injury by using appropriate gear and sports equipment, looking for safe environments, following rules and policies, and making sensible choices about when, where, and how to be active.
• People with chronic conditions and symptoms should consult their health‑care provider about the types and amounts of activity appropriate for them.
For Pregnant and Postpartum Women
• Healthy women who are not already highly active or doing vigorous‑intensity activity should get at least 150 minutes of moderate‑intensity aerobic activity a week during pregnancy and the postpartum period. Preferably, this activity should be spread throughout the week.
• Pregnant women who habitually engage in vigorous aerobic activity or are highly active can continue physical activity during pregnancy and the postpartum period, provided that they remain healthy and discuss with their health‑care pro- vider how and when activity should be adjusted over time.
For Adults with Disabilities
• If able to do so, get at least 150 minutes a week of moderate‑ intensity, or 75 minutes a week of vigorous‑intensity aerobic activity, or an equivalent combination of moderate‑ and vigorous‑intensity aerobic activity. Aerobic activity should be performed in episodes of at least 10 minutes and, prefer- ably, should be spread throughout the week.
• If able, do muscle‑strengthening activities of moderate or high intensity that involve all major muscle groups on 2 or more days a week.
• If unable to meet the guidelines, engage in regular physical activity consistent with abilities; avoid inactivity.
• Adults with disabilities should consult their health‑care provider about the amounts and types of physical activity that are appropriate for their abilities.
For People with Chronic Medical Conditions
• Adults with chronic conditions can obtain important health benefits from regular physical activity.
• When adults with chronic conditions do activity according to their abilities, physical activity is safe.
• People with chronic conditions and symptoms should consult their health‑care provider about the types and amounts of activity appropriate for them.
For Adolescents and Children
• Children and adolescents should do 60 minutes (1 hour) or more of physical activity daily.
Aerobic: Most of the 60 or more minutes a day should be either moderate‑ or vigorous‑intensity aerobic physical activ- ity, and should include vigorous‑intensity physical activity at least 3 days a week.
Muscle-strengthening: As part of their 60 or more minutes of daily physical activity, children and adolescents should include muscle‑strengthening physical activity on at least 3 days of the week.
Bone-strengthening: As part of their 60 or more minutes of daily physical activity, children and adolescents should include weight‑bearing physical activity (such as walking, jumping, or running) on at least 3 days of the week.
• Young people should be encouraged to participate in activi- ties that are age‑appropriate, enjoyable, and offer variety.
For Adults
• All adults should avoid inactivity. Some physical activity is better than none, and adults who participate in any amount of physical activity gain some health benefits.
• For substantial health benefits, adults should do at least 150 minutes (2 hours and 30 minutes) a week of moderate‑ intensity, or 75 minutes (1 hour and 15 minutes) a week of vigorous‑intensity aerobic physical activity, or an equivalent combination of moderate‑ and vigorous intensity aerobic activity. Aerobic activity should be performed in episodes of at least 10 minutes, and preferably, it should be spread throughout the week.
• For additional and more extensive health benefits, adults should increase their aerobic physical activity to 300 min- utes (5 hours) a week of moderate intensity, or 150 minutes a week of vigorous intensity aerobic physical activity, or an equivalent combination of moderate‑ and vigorous‑intensity activity. Additional health benefits are gained by engaging in physical activity beyond this amount.
• Adults should also do muscle‑strengthening activities that are moderate or high intensity and involve all major muscle groups on 2 or more days a week, as these activities provide additional health benefits.
For Older Adults (Age 65+)
• When older adults cannot do 150 minutes of moderate‑ intensity aerobic activity a week because of chronic condi- tions, they should be as physically active as their abilities and conditions allow.
• Older adults should do exercises that maintain or improve balance if they are at risk of falling.
• Older adults should determine their level of effort for physi- cal activity relative to their level of fitness.
• Older adults with chronic conditions should understand whether and how their conditions affect their ability to do regular physical activity safely.
Part Three Nutrition and Fitness266
to break up their day with a run at noon, or relax after work, or run before bedtime. Some find it helpful to lis- ten to music, whereas others prefer the sounds of nature or other aspects of life. Some prefer to exercise with a partner or a group, whereas others prefer to do it alone. Indoor exercisers may find that watching television holds their interest. The key point is that the surroundings may make the difference between maintaining or giving up a program. A survey of 21,750 Consumer Reports readers found that successful exercisers tended to choose the most convenient time of day (56%), exercise near home or work (48%), exercise outdoors (42%), join a health club (32%), and/or exercise with friends or family (24%).11
If physical activity is substantially reduced, many of the effects of exercise training on fitness will diminish within 2 weeks and will disappear within 2 to 8 months if significant activity is not resumed.12
Stretching Exercises Stretching exercises are effective in increasing flexibility, and thereby can allow people to more easily do activities that require greater flexibility. Shoulder stretches are particularly useful for swimmers because they enable the arms to be optimally placed for power strokes. Muscles are arranged in sets that are antagonistic to each other. Muscle spasms can occur when the strength and flexibility of antagonistic muscle groups are too far
out of balance. For example, low‑back pain can occur when the back muscles are considerably stronger and less flexible than the abdominals. Exercises that strengthen the abdominals and stretch the lower back can help prevent a recurrence. The muscles should be completely warmed up be- fore flexibility exercises are performed. For this reason, stretching fits best at the end of an exercise session. It is widely believed that stretching can prevent injuries and prevent or reduce the soreness that occurs after doing movements to which the body is not adapted. This seems like common sense, yet there is little scien- tific support for these beliefs.8 Cochrane reviews, for example, have found “insufficient evidence” to suggest that stretching exercises prevent injuries in runners13 and have “minimal or no effect” on the muscle soreness experienced after activities performed by healthy young adults in laboratory settings.14
Assessing Exercise Intensity The demand exercise places on the heart can be measured and expressed in metabolic equivalents (METs). A MET is the amount of oxygen consumed while a person sits at rest—approximately 3.5 ml of oxygen per kg of body weight per minute. Performing a 2‑MET activity will raise oxygen consumption to 7 ml/kg, while a 3‑MET activity will triple the energy demand. Blair15 lists these MET values for various common activities:
Activity Cardiorespiratory Strength Muscle Endurance Flexibility
Aerobics, high‑impact VM M VM M Aerobics, low‑impact M‑VM S‑M M‑VM M Aqua exercises L S‑M M M Basketball VM S‑M M M Bicycling VM M M S‑M Bowling L L L L Calisthenics S‑M S S‑M S Dancing (vigorous) VM S‑M M M Golf S‑M S S S Jogging VM S‑M M S‑M Rope jumping VM M M‑VM S Swimming VM S‑M M M Tennis M‑VM S‑M VM S‑M Walking S‑M L‑S S‑M L
*The extent of benefits from any sport depends on frequency, duration, resistance, and muscles involved. Key: VM = very much, M = much, S = some, L = little. Modified from Kusinitz I and others. Physical Fitness for Practically Everybody. Mt. Vernon, N.Y., 1983, Consumer Reports Books.
Fitness Contributions oF various aCtivities* Table 13-3
Chapter Thirteen Fitness Concepts, Products, and Services 267
moderate intensity (3 to 4.9 mets): Calisthenics, golf (not rid- ing in a cart), weightlifting, recreational volleyball, walking at 3 to 4 mph (15 to 20 minutes per mile)
Hard intensity (5 to 6.9 mets): Aerobic dance, doubles tennis, ice or roller skating, slow‑paced swimming, walking at 4.5 to 5.5 mph (10.9 to 13.3 minutes per mile)
very Hard intensity (over 7 mets): Running, fast‑paced swimming, rope jumping, singles tennis, competitive racquetball
Figure 13‑2 shows additional MET values. MET values can be used to guide doctors who pre- scribe exercise programs for patients recovering from heart attacks or other cardiovascular problems. For ex- ample, if a 5‑MET level of exertion on a stress test does not cause symptoms, it is unlikely that the heart will be strained by exercise at home.
Balance Training Balance training involves exercises that are designed to improve the ability to withstand challenges from postural sway or destabilizing stimuli caused by self‑motion, the environment, or other objects. People at risk of falls should do balance training 3 or more days a week and do standardized exercises from a program demonstrated to reduce falls. Examples of these exercises include backward walking, sideways walking, heel walking, toe walking, and standing from a sitting position. The exercises can increase in difficulty by progressing from holding onto a stable support (like furniture) while doing the exercises to doing them without support. It is not known whether different combinations of type, amount, or frequency of activity can reduce falls to a greater degree.
“Mind-Body Exercise” “Mind‑body exercise” is purported to “unify” the mind and body through training of motor coordination and awareness of body sensations. Ives and Sosnoff16 have identified 20 systems ranging from Pilates, which is vigorous enough for strength training, to others that in- volve minimal physical exertion. The three most popular methods are Pilates, tai chi, and yoga. Pilates is a series of low‑impact flexibility, muscular‑ endurance, and breathing exercises, most of which start from a supine position and involve lifting a combination of limbs, head, and back. The more complicated ones require the use of springs and pulleys, rigged up on spe- cial equipment. Proponents claim the exercises stretch, strengthen, and “balance” the body. However, a 6‑month study of 32 participants found no statistically significant changes in truncal lean body mass, height, weight, or
other body composition parameters or on self‑assessment of health. The authors concluded that although Pilates training may result in improved flexibility, its effects on body composition, health status, and posture are more limited and may be difficult to establish.17
Tai chi combines breathing exercises with stretches and dance movements that can provide relaxation and improve flexibility and balance.18 The extent to which it contributes to aerobic fitness depends on the intensity
Running or figure skating 7:23 min/mile (12.9)
Cross‑country skiing 9.5 min/mile (12.2)
Jogging 8:35 min/mile (11.2)
Soccer (10.3) Raquetball/squash (10.0) Karate (10.0)
Swimming 41 sec/25 yds (8.9)
Riding horse at a gallop (8.6)
Kayaking (7.8) Touch football (7.5)
Ballet (7.0) Tennis singles (6.7)
Aerobic dancing (3.9–6.0)
Golf, carrying clubs (5.1) Ice skating 15.5 mph (4.8) Tennis doubles (4.5)
Ballroom dancing (4.0)
Walking 20 min/mile (3.2) Yoga (3.2) Bowling (3.0)
Golf, riding cart (2.5) Fishing from boat (2.3) Motorcycling (2.2)
13
12
11
10
9
8
7
6
5
4
3
2
1
Mets
Figure 13-2. Approximate metabolic equivalents (METs) of various recreational activities.
Sitting at rest (1.0)
Part Three Nutrition and Fitness268
and duration of the sessions. It is probably most useful for elderly unfit individuals. Yoga encompasses a large number of religious and quasi‑religious practices based on ancient Indian beliefs about human existence. Its philosophy postulates five “sheaths” of existence: the physical body, the vital body, the mind, the higher intellect, and the abode of bliss (universal consciousness). The vital body is said to be composed of prana, “life energy” that flows through invisible channels. Disease is said to arise through imbal- ance of the three lower sheaths. In the healthy state the positive energy of the highest sheath supposedly perco- lates through the lower ones and brings total “harmony” and “balance” to the mind, body, and spirit. It is possible to participate and benefit without buy- ing into the mystical belief system. The various styles of yoga that people use for health purposes typically combine physical postures, breathing techniques, and meditation or relaxation. Yoga can improve flexibility but is unlikely to provide other fitness benefits. Ives and Sosnoff16 caution:
The field of mind‑body exercise is wide open, unregulated, and filled with grand promises. Our advice is to thoughtfully consider these methods but not to the exclusion of traditional strength, aerobic, and flexibility exercises.
Injury Prevention Many people are injured yearly in sports and recreational activities. Injuries range from minor aches and pains to severe overuse syndromes, fractures, and connective tissue tears. In 2003, the U.S. Centers for Disease Con- trol and Prevention reported that Americans received medical attention each year for about 7 million sports or exercise‑related injury episodes.19 The most common problems are injuries due to overuse—wear‑and‑tear to the muscles, ligaments, tendons, and joints (Table 13‑4). Injury can also result from improper use of equipment or from use of equipment that is poorly constructed. The risks of injury are greater for sedentary indi- viduals and those who thrust themselves into activities that are either too strenuous, prolonged, or frequent. As Jones and others20 have noted: Excessive activity without adequate conditioning and suffi- cient rest equals trouble. . . . All changes in frequency, duration, and intensity of exercise should be gradual. Serious athletes and weekend warriors alike should undergo overall strength and flexibility training in addition to the specific techniques required by the particular sport or activity. Flexibility is an important component of fitness, as is general body strength. An overuse injury is a signal that the body is working against itself. Appropriate strengthening and flexibility exercises, as well as an organized, progressive
exerCise-related injuries and illnesses Table 13-4
Body Part Ankle
Back
Calf Ear
Elbow Eye Foot
Head Hip, groin Knee Neck Shoul-
der Thigh
Injury or Symptoms Twists, sprains
Strain, soreness, muscle spasms, disc herniation
Achilles tendinitis, shin splints Swimmer’s ear (external otitis)
Soreness at joint (tennis elbow) Conjunctivitis Blisters, jogger’s heel (plantar
fasciitis) Accidental injury Pulled muscle Torn cartilage and other problems Tightness or soreness Bicipital tendinitis and other types
of painful conditions of the joint Pulled hamstring muscle
Contributing Factors Overtiredness
Sudden lunges or twists when tired; improper lifting technique
Overuse Inflammation due to prolonged expo-
sure to moisture Overuse and poor technique Irritation from chlorine Overuse
Blow to head from a fall Overuse, changes of exercise routine Overuse, changes of exercise routine Overworking of muscles Overuse or poor technique
Inadequate warm‑up in sports involv‑ ing running, jumping, or twisting
Activities
Racquet sports, volley- ball, basketball
Running, weightlifting
Running, aerobics Swimming
Racquet sports Swimming Running, jumping
Cycling Running Running, weightlifting Cycling Swimming, tennis,
baseball Football, racquet
sports, soccer, sprints
Chapter Thirteen Fitness Concepts, Products, and Services 269
increase in the duration and intensity of exercise, will help to cure the problem and prevent its recurrence.
Well‑designed exercise programs include time for the body to recover. High‑resistance exercises such as heavy weightlifting or intense anaerobic activities (such as sprinting, jumping, competitive tennis, or competitive swimming) require 36 to 48 hours for full recovery. Aero- bic activities and light‑resistance exercises can be done daily (or even twice daily). Exercise programs usually become highly individualized and may vary considerably from season to season. Consumer Reports21 notes that because old injuries increase the risk of new injuries to the same muscles and joints, it is important to protect injured areas until they are completely healed. Table 13‑5 outlines sample programs that contribute to all‑around fitness, weight control, and recreational sports ability.
personal trainers
A qualified personal trainer can assess individual fitness, create goals based on the status of that assessment, and
motivate the client to adhere to the program as outlined. A proper program should address both the exercise and nutritional components of the person’s lifestyle. Evans22 recommends choosing a trainer with an ac- credited bachelor’s, master’s, or doctoral degree in exer- cise science, kinesiology, exercise physiology, physical education, sport management, or something similar. Comprehensive training takes 2000 to 3000 hours and provides a solid background in anatomy, physiology, biomechanics, and exercise prescription techniques. Many credentials presented by people in the fitness industry are not meaningful. Some certifications may cover just specific exercise gimmicks and techniques for which promoters make claims that are not scientifically defensible. Table 13‑6 lists organizations that certify personal trainers and other types of instructors. Some of these organizations offer their own courses. Although these certifications are legitimate, most require far less training than is required to obtain a degree. Thus, a thorough investigation of a potential trainer’s credentials should consider the extent and type of training as well as the requirements for certification.
Primary Goal Moderate‑level cardiorespiratory fitness High‑level cardiorespiratory fitness* Moderate‑level overall fitness
High‑level overall fitness*
Moderate‑level weight control High‑level weight control High‑level weight control and fitness*
Bodybuilding
Recreational sport performance
saMple exerCise prograMs
Table 13-5
Weekly Schedule Aerobic exercise 3 days (every other day) Aerobic exercise 5–6 days Mon‑Wed‑Fri: aerobic exercise Tues and Thur: weightlifting or other resistance exercise Sun‑Tues‑Thur‑Sat am: distance running Mon‑Wed‑Fri am: interval running†
Sun‑Tues‑Thurs pm: lap swimming, weightlifting, or other resistance exercise
Mon‑Wed‑Fri pm: raquetball, tennis, handball, or basketball Daily am: walk‑jog‑run Daily am and pm: walk‑jog‑run Daily am: aerobic activities Sun‑Tues‑Thurs pm: lap swimming, weightlifting, or other resistance
exercise Mon‑Wed‑Fri pm: raquetball, tennis, handball, or basketball Sun‑Tues‑Thurs‑Sat: walk‑jog‑run Mon‑Wed‑Fri: high‑resistance training Daily am: walk‑jog‑run or bike Sun‑Tues‑Thurs‑Sat pm: participation in specific sport Mon‑Wed‑Fri pm: supplemental training for specific sport
*High‑performance programs exceed what is needed to achieve a fitness level associated with good health. However, high‑level fitness may be desirable for achieving athletic prowess or for other reasons.
†Interval running involves timed, fast‑pace runs over measured distances for 1.5‑ to 3‑minute periods, with walking until recovery in‑between runs.
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American College of Sports Medicine (ACSM) American Council on Exercise (ACE) Cooper Institute (CI) International Fitness Professionals Association (IFPA) National Academy of Sports Medicine (NASM) National Council on Strength & Fitness (NCSF) National Exercise and Strength Trainer’s Association
(NESTA) National Exercise Trainer’s Association (NETA) National Federation of Professional Trainers (NFPT) National Strength and Conditioning Association (NSCA)
organizations that CertiFY personal trainers
Table 13-6
sports MediCine speCialists
Most exercise‑related injuries are minor and will resolve with reduced activity levels or rest. A general rule for muscle soreness or joint pain is to continue exercising at a lower level of intensity if the pain or soreness goes away after warming up. If the pain persists or worsens, the exercise program should be discontinued until activi- ties can be comfortably resumed. A physician should be consulted if (a) pain is severe or persists, (b) movement of the injured part of the body is difficult or impossible, or (c) the injury does not appear to be healing. When professional care is needed, the best first source is probably one’s primary physician. Physicians who are certified in a primary‑care specialty can obtain a Certificate of Added Qualifications in Sports Medicine by taking 12 to 24 months of fellowship training and passing an examination given by the American Board of Medical Specialties or American Osteopathic Asssocia- tion. Several other types of professionals can offer advice about exercise programs, procedures, and equipment or provide services to people who are injured. Some work primarily by referral, and some practice independently:
atHletiC trainer: Athletic trainers help people plan exercise programs. They can also work under physician supervision to help treat sports injuries.
exerCise pHysiologist (ph.d. or m.s.): Someone who helps design exercise programs for healthy athletes, hospital pa- tients, or fitness club clients. Many are research specialists. Those who work in health clubs generally have a master’s degree.
massage tHerapist (massotHerapist): A certified or licensed person who may help speed up recovery by stroking and kneading muscles.
ortHopediC surgeon (m.d. or d.o.): A physician who special- izes in the diagnosis and treatment of problems of muscles, bones, joints, and the spine.
pHysiCal tHerapist (p.t. or r.p.t.): A trained and licensed indi- vidual who helps maintain and restore function to injured limbs and joints using strengthening machines, various exercises, heat, and water; works closely with physicians in rehabilitation.
podiatrist (d.p.m.): A person medically trained in the pre- vention, diagnosis, and treatment of injuries, disease, and abnormalities of the foot and ankle.
sports nutritionist (r.d.): A registered dietitian or other nutritional specialist who helps with the nutritional needs of athletes.
sports psyCHologist (ph.d. or m.s.): Someone who works with athletes and teams to provide stress relief and to help meet specific training and competition goals.
exerCise equipMent and supplies
Americans spend several billion dollars a year on ex- ercise devices. Some contribute greatly to physical fit- ness and safety, whereas others have little or no value. Consumers contemplating purchase or use of exercise equipment should consider whether the benefits to be derived will contribute to endurance, flexibility, strength, and cardiorespiratory efficiency. Consumers may also investigate whether similar benefits can be obtained without equipment or in a less expensive way. Most people who purchase exercise equipment waste money, largely because boredom sets in. A 1998 survey found that fewer than one‑third of machines bought by Con- sumer Reports readers who began exercise programs during the previous 4 years were still in use.23
It is important for consumers to clearly understand their fitness goals, to obtain expert help in using equipment, and to check the quality of items before purchasing them. Sites such as craigslist.org carry many ads for used equipment at low prices. Consumer Reports magazine and www.consumerreports.org periodically publish test results and buying and safety advice on exercise equipment. Exercise Bicycles More than 100 brands and models of exercise bicycles are available, most costing between $150 and $2000. The best ones have rigid construction, a comfortable seat, easily adjustable height, and smooth riding action. Three types are marketed. Regular upright bikes involve pump- ing with the legs to turn a flywheel linked to the pedals. Resistance to pumping is provided by a strap around the wheel or a set of caliper brake pads. The tighter the strap
Chapter Thirteen Fitness Concepts, Products, and Services 271
or pads, the more difficult it is to turn the wheel, and the greater the workout. Dual‑action uprights have their handlebars linked to the pedals so they move back and forth as the bike is pedaled; these provide exercise for the arms and legs. Recumbent bikes are operated by sitting in a seat resembling the bucket seat of a car; the user may be more comfortable and have less strain placed on back muscles. Training stands, which support a regular bike and add a resistance device, cost less but will not provide an aerobic workout for someone in good shape.
Elliptical Exercisers These are a cross between an exercise bike and a ski machine. They provide an effective cardiovascular work- out, especially for advanced beginner and intermediate exercisers.
Cross-Country Ski Exercisers Cross‑country ski machines can help produce weight loss, stimulate interest in cross‑country skiing, and strengthen and firm many muscle groups, especially in the legs. When planning to purchase a cross‑country ski exerciser, look for smoothness of operation, overall stability, foot security, a fit that allows adequate adjust- ment for people of different height, ease of resistance adjustment, and quiet operation.
Treadmills Motorized treadmills provide the same benefits as walk- ing or running outdoors with less chance of injury and regardless of weather conditions. Most treadmills permit the user to control the rigor of the workout by adjusting the speed and incline of the track. Low‑priced models (under $500) are inconvenient to adjust and are too short and/or too slow for jogging. Mid‑priced models ($500 to $1000) offer a long platform, higher speeds, and the abil- ity to adjust the incline conveniently. Some can be used for jogging, but they may not last long if the user weighs more than 150 pounds. High‑priced models ($1600 and up) are built more sturdily, are more convenient to ad- just, and have more electronic gadgetry. Nonmotorized treadmills are not recommended because they force the user to walk in an unnatural position. A study compared the exercise workload and how people felt when using a ski simulator, an exercise bike, a rowing machine, a stairstepper, and a treadmill for walking. The subjects of the study were healthy, young adult volunteers who were trained to rate their perceived degree of exertion. The researchers found that the treadmill produced the highest energy expenditure (and therefore the best aerobic workout) for each level of perceived exertion.24
Stair Steppers and Climbers Steppers are single‑action devices that work out only the lower body. Climbers offer upper‑body exercise with hand grips that can be pulled down and pushed up while stepping with the feet. With the better models, the feet move independently, which means that each leg must do the work of stepping without help from the other.
Bicycles for Riding Consumer Reports classifies bicycles into four groups: comfort bikes (for leisurely recreational riding), moun- tain bikes (for riding on rugged trails), road bikes (for fast or serious mileage), and fitness bikes (those who simply want to burn calories or improve cardiovascular fitness, or for daily short‑haul commuting).
Bicycle Helmets Studies have found that helmet use can substantially reduce the risk of head injury among cyclists. Yet only small percentages of children and adults wear one. Stan- dards required by law are set by the Consumer Product Safety Commission. A properly fitting helmet should tilt up or down very little when the straps are snug.
Rowing Machines These devices can contribute to strength and cardio- vascular fitness if frequency, intensity, and duration are maintained. However, a high degree of motivation is needed to prevent boredom from use. There is some risk for people with back problems. High‑quality machines cost at least $250. Good equipment has sturdy tubing; parts that fit snugly together; a padded, contoured seat that slides smoothly; and double‑piston “oars” with adjustable tension. Table 13‑7 compares 20 widely advertised types of exercise products, many of which are questionable.
Electronic Feedback Electronic monitors found on many exercise machines (or available as an accessory) provide feedback on heart rate, speed, miles pedaled or traveled, and calories burned. Devices that report distance, speed, repetitions, elapsed time, and heart rate are usually accurate. Those that report calories burned may have a large margin of error. Generally, the more gadgetry, the higher the cost. Portable monitors check the pulse during exercise to enable individuals to know whether they are performing at an appropriate pulse rate (usually 60% to 90% of maxi- mum). There are two types: (1) finger or earlobe sensor and (2) transmitter worn on the chest that broadcasts to a watch that provides the pulse readout. The finger or earlobe type is less expensive but less accurate. This
Part Three Nutrition and Fitness272
CoMparison oF exerCise equipMent
Table 13-7
Description Barbells: Forms and shapes
vary in size and weight; made of iron, rubber, plas- tic; water‑ or sand‑filled
Bicycle, stationary: A bicycle without the usual wheels that registers speed and dis- tance; can pro vide varying de grees of resistance; some also have rowing action
Bull‑worker: Two spring‑loaded cyl inders about 3 feet long with handles at each end that telescope when compressed
Bun and thigh rocker
Chinning bar: Bar hung in doorway, at tached to ceil- ing or wall, or included in multiple equipment system
Chest pull/chest expander: Heavy rubber or elastic bands or springs with handles on each end
Exercise balls (also called fitness balls and stability balls): Soft, inflatable rub- ber balls 14 to 34 inches in diameter
Grip strengthener: Rubber ball; fairly hard substance
Jump rope: Made of cotton, nylon, polyester material, with handles
Mini‑trampoline: Steel frame with tough vinyl cover, 34 x 10 inches
Advertising Claims Tone muscles; very light; easy
to store
Permits aerobic fitness in home or office; promotes circula- tion, improves muscle tone and coordination; increases endur ance
Isometric/isotonic exerciser; develops mus cles and builds body through push, pull, and press; easy to use; takes 70 seconds a day
Does the job of six pieces of lower‑body gym equipment
Create a strong back in no time.
Isometric/isotonic exercise; no long, tiring workouts; tones and shapes all muscle groups in one fourth the time required for barbells and dead weights
Total body conditioning; core strengthening; increase flex- ibility, balance, and coordina- tion; fun; safe; adds variety to workouts.
Builds muscles in wrist/forearm by simply squeezing ball; also exercises toes and instep; great tension reliever
Improves cardiorespiratory efficiency (CRE); leg muscle endurance/stamina
Combines aerobic exercises to work on each muscle in body and heart; easier on knees than jogging; improves posture, balance, digestion; strengthens heart; enjoyable
Comments Provide resistance exercise; especially use ful
with other equipment; benefits de pend on types of exercise, amount of weight, and frequency of use. Loosely handled free weights are hazardous to fingers and toes
Extent of resistance and intensity will de‑ termine benefits
Perhaps some isometric value; limited to upper body, excluding abdominals; “70 seconds” ad vertising claim unreasonable
Basically a squat machine that does one thing that can be done without costly equipment
Benefits limited to upper body strength de‑ velopment; strenuous for the unfit; can be made eas ily and cheaply in a home work- shop
Good isotonic trainer for upper body; pro‑ vides limited resistance exercise benefits; resistance exercise can speed up strength improvement, but time requirement can not be verified; does not provide isoki netic or isometric exercise
Can help strengthen muscles of abdomen, hip lower back, buttocks, and pelvis; proper size, inflation, and exercise technique are needed to avoid injury; some brands have burst when overinflated
Any round rubber object or other resistant substance will strengthen muscles; frequen- cy and duration important; no evidence of tension relief
Improves CRE; develops leg strength; excel- lent activity with inexpensive equipment; can be homemade; weighted ropes available
No effect on digestion; good if intensity is high; probably can benefit the unfit; must work very hard for aerobic effect; hazard of losing balance and falling; some claims are conjecture; less traumatic to the body than running or jumping on hard surfaces
Chapter Thirteen Fitness Concepts, Products, and Services 273
CoMparison oF exerCise equipMent—Cont’d. Table 13-7
Description Multipurpose gyms; home fit-
ness system/portable gym/ weight training complex: Contain various weight‑ training items such as a sit‑ up/slant board and leg lifts
Orthopedic inversion ma- chine: Upside‑down stretch that relaxes back and abdominal muscles
Push‑up aids: Pair of steel bars or handles that in- crease force needed to do push‑ups
Sit‑up bar: Bar attached 6 inches from wall for hook‑ ing feet when exercising
Slant board: Vinyl‑covered, padded board, 12 to 14 inches wide; can be tilted up or down; person lies on it when exercising
Stair climber: Grasp handle and begin to step and pull, working upper body and lower body at same time
Stairway stepping: 2‑, 4‑, 6‑, and 8‑inch blocks; 4‑inch high platform to step; plus video
Stomach eliminators: Cross- bar with heavy spring attached; stirrups‑like foot grips
Thigh machine: Bar 12 inches from floor, movable against some resistance by the arms and legs
Tummy trimming/stomach trimmer: Wide rubber/elas- tic belt that tightens, shapes abdominal area
Advertising Claims Permits full range of profes-
sional gym exercises; over 50 simple exercises from heavy bodybuilding to general physical fitness; do leg lifts, leg curls, arm curls, and arm rowing
Easy, safe; strengthens muscle; supports back; painless invert- ed abdominal curls; improves circulation; releases stress; adds energy and vitality
Provides better, quicker results than ordinary push‑ups; allows greater range of motion
Strengthens middle; shapes legs
Firms muscles; orthopedically approved
Work upper and lower body at same time; work every muscle group; for serious training
Latest in low‑impact video; mixes stair climbing and jazz aerobics
Slimmer, younger look in 2 weeks; flattens stomach; strengthens chest, arms, back, thighs
Slims legs; tones and stretches all body parts; over 40 iso- tonic and isometric exercises
Look inches slimmer instantly; flatten stomach; no diet; no exercise
Comments Provides resistance exercise that can speed up
strength development and fitness; limited cardiorespiratory involvement; body parts involved depend on choice of exercises; some equipment usable in small space in home; less costly equipment and programs are available
May strengthen back muscles with some trunk value; no evidence to support release of stress or improve circulation; high‑cost item; some potential for injury
Resistance may quicken benefits; whether better is unproven; same results can be achieved without equipment
Especially helps tone abdominals if knees in bent position; “shaping of legs” claim is puffery; with feet locked, hip flexors are involved
Greater benefit because of greater resistance from gravity than in flat sit‑ups; use of bar- bells and weights increases resistance and benefits; may be part of home gym equip- ment; knees should be bent during use
Good aerobic activity; most muscles involved; limited arm and very limited abdominal and back involvement
Good aerobic and strength activity; limited upper arm and body involvement unless weights are used; could be strenuous and should be taken in gradual steps; 6‑ to 8‑inch steps for advanced fitness
Benefits limited; some back and arm strength; hazard—breakage of spring
May strengthen a few muscles but does not affect all body parts or make legs slimmer
Promotes fallacious spot‑reducing concept; spot exercises can develop but not slim specific muscle groups
Part Three Nutrition and Fitness274
equipment may be an unnecessary expense because there is another easy way to check the pulse rate. Place the first three fingers of one hand on the inside of the wrist, below where the bone connects to the thumb, and feel the beat. Count the number of pulsations for 15 seconds and multiply by 4 to get the 1‑minute pulse rate. For serious exercisers who wish to build up to and remain safely within the high end of the target range, the chest transmitter is the only one that is worthwhile. Excellent ones can be obtained for about $100. Some fitness facilities have computers to help people make their workouts more precise and efficient. Some can create exercise programs tailored to specific goals. For example, computers can provide an exercise pre- scription based on a person’s interests, times available, attendance, and fitness scores. Computerized devices can also be used to test muscle strength and to prescribe activities needed to increase strength. Some athletes use the devices to compare their own performances with those of champions to determine weaknesses. Profes- sional help may be needed to utilize these approaches.
Strength-Training Equipment There are three basic types of strength‑training equip- ment. Free weights include dumbbells, barbells, and hand weights. Weight stacks use either discs or blocks of weights attached to a lever or pulley system. Other machines that do not use weight stacks use pneumatic resistance, hydraulic resistance, compression of rubber, flexible rods, or other mechanisms within the machine. Prospective purchasers of such equipment for home use should consider price, size (vs size of exercise area), safety (sturdy construction with no sharp edges), and quality of instructional material. It is generally better to investigate equipment at a local store than to rely on advertising claims. Athletic Shoes The average person takes thousands of steps per day. Each step exerts a force greater than the body weight on certain bones and muscles of the feet. Running more than triples that force, and various other fitness and athletic activities also increase it. Cumulative pounding, compli- cated by poorly fitting shoes, can cause aching feet and other foot problems. Foot problems can alter a person’s gait and posture, causing pain to progress to the ankles, knees, hips, and lower back. One way to properly take care of the feet is to have proper athletic shoes. The nature of the physical activity determines the type of shoe needed; good ones typically cost $45 to
$135. They are designed to provide rigidity, durability, flexibility, proper fit, adequate cushioning (shock absorp- tion), and comfort. Figure 13‑3 illustrates the features of a good walking shoe. When buying shoes, the most important consideration should be a good fit; they should feel comfortable from the moment they are put on. These additional tips may help:
• Give preference to stores that employ a professional shoe fitter (pedorthist) or serious recreational athlete who knows about foot problems and biomechanics.
• Shop late in the day or after exercising, when your feet are largest. Don’t expect athletic shoes to stretch.
• Wear the kind of socks you plan to wear when exercising. • An old pair of athletic shoes may help a knowledgeable
salesperson determine what is best for you. • Be sure that the toe box is wide enough to permit toes to
wiggle and long enough to have about half an inch of space in front of the longest toe.
• Feel inside for seams and ridges. • Be sure the shoes bend easily at their widest part. Running
shoes need more flexibility in the toe area in order to push off; walking shoes should be more rigid to permit rolling off the toes and joints rather than bending through them.
• Take a test walk or jog in the store.
The American Running Association’s Web site (www.americanrunning.org) offers an interactive ques- tionnaire that yields a list of recommended shoes. Snug, poorly ventilated shoes and damp, sweaty socks provide a breeding ground for athlete’s foot, a fungal infection that causes itching, redness, and skin peeling between the toes. To prevent this condition, daily washing of the feet with soap and water is advis- able, and the feet, especially between the toes, should be dried thoroughly. A 1% tolnaftate solution or ointment
Padded Achilles tendon counter
Padded tongue and ankle collar
Firm heel counter
Heel well‑ cushioned
Insole comfortable and well‑fitted
Substantial arch support
Soles durable and flexible
Wide toe box
Uppers made of breathable materials
Figure 13-3. Features of a good walking shoe.
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can also help protect against athlete’s foot. Chapter 18 discusses its treatment. Running shoes with elevated cushioned heels and pronation control features tailored to foot type are widely considered best for distance runners. However, a system- atic review found that controlled studies to determine injury rates, enjoyment, and performance rates have not been done and therefore “prescription of this type of shoe is not evidence‑based.”25
Sports Bras Because anatomical support within the female breast is limited, external support in the form of a bra is advisable to reduce breast motion and discomfort during exercise. Research studies have confirmed that well‑designed sports bras, such as encapsulation bras (in which each breast is supported in a separate cup), are more effective for these purposes than standard fashion bras or from crop tops that compress the breasts against the chest wall.26
Questionable Devices Many types of exercise devices and equipment are ad- vertised with claims that have no scientific foundation. Bogus claims regarding weight control, body shaping, and effortless muscle‑building are the most common. Continuous passive motion tables. Continuous passive motion (CPM) tables are motorized in segments so that isolated muscle groups can be moved through their range of motion without effort on the part of the user. CPM units have been used in the rehabilitation of injured athletes to restore and maintain joint motions and have revolutionized some types of orthopedic surgery. They are useful during recovery from joint replacement, ligament reconstruction, and various other operations and illnesses. They provide movement that could help with joint flexibility for the elderly, sedentary people, and those with neuromuscular disorders. However, they have also been used in clinics and salons where they are claimed to provide “exercise without exercise” and to tone muscles, reduce stress, improve posture, cause weight loss, and eliminate excess water retention. These claims are unsubstantiated. Consumers should be aware that CPM units have value in therapy and rehabilitation but will not benefit healthy, active people. “Gravity inversion” devices. So‑called gravity boots are used with support systems that hold people in an upside‑down position. The boots were invented in 1965 by Dr. Robert Martin, an osteopath who developed them to relieve stress on spines and joints caused by
standing and sitting. Martin claimed that body inversion decompresses spinal discs, stretches back muscles, and improves overall flexibility, posture, and well‑being— everything from hemorrhoids to sagging bowels. He also espoused a long‑held notion that gravity produced aging, and therefore that positioning the body upside down would have an opposite effect. However, there is no scientific evidence that hanging upside down has any health benefit. Critics have warned that inversion raises blood pressure considerably and can harm people with glaucoma, spinal instability, or a hiatal hernia. Abdominal exercisers. Many devices are claimed to enable people to “flatten” their abdomen by tightening and toning the abdominal muscles. However: (a) ab- dominal exercises are unlikely to flatten a flabby stomach because they cannot spot‑reduce the layer of fat between the muscles and the skin, (b) some of these devices help exercise the abdominal muscles by making it easier to do sit‑ups, but others actually exercise the arms rather than the abdominal muscles, and (c) it is not necessary to spend money to “tone one’s abs.” Sit‑ups with knees bent and hands on thighs (not behind the neck) will do an effective job. “Spot-reducers.” Some products or devices are claimed to reduce or remove fat from specific parts of the body. In controlled studies that compared individu- als who performed general exercises with others who performed spot exercises, both groups lost fat where it was most conspicuous, regardless of the type of exercise. Exercise does “burn off” fat and calories, but it does this throughout the body and not just in an exercised area. There is no such thing as spot‑reducing. Special garments. Many types of garments have been marketed with fanciful claims that fitness, weight‑ reduction, or body‑shaping can be produced without any effort on the part of the wearer. Rubber sweatsuits have been claimed to cause weight loss by increasing the amount of water lost through perspiration. (Of course, when the wearer consumes water, any such weight returns.) Heat belts have been marketed with similar claims. Some have chemical heat packs to increase the temperature around the waist and have elasticized waist cinchers to fit close to the body to keep sweat from evaporating. An “effortless exerciser,” a tight‑ fitting garment said to have been perfected by a “lead- ing physician” (unidentified), was advertised to give a new body and new heart in just 2 easy minutes a day. The ad claimed that a hidden “muscle‑girdle” that one never removes would develop the body. Advertisements informed women that the device could squeeze their hips
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away, firm their bustline, and put a glow in complexions that no cosmetic could match. Electrical nerve/muscle stimulators. Electrical nerve stimulators (ENS)/electrical muscle stimulators (EMS) are sold through the mail or without prescription at $19.95 and up; professional models used in hospitals and other places are priced at $2500. Powered by a 12‑volt battery, these machines stimulate nerves that cause muscles to contract. Some consumers purchase this equipment for home use; others pay $25 or more for 45‑minute sessions at slimming parlors and other such establishments. The advertisements for these prod- ucts stress an effortless “no‑sweat workout,” which is a method of moving muscles and obtaining exercise without effort. One advertisement stated that users can get the equivalent of 10 miles of jogging while lying flat on their back. Other ads claim that ENS/EMS will strengthen the arm, leg, and other muscles; slim and trim the body; shape and contour the body; produce a facelift without surgery (remove wrinkles); control weight; spot‑ reduce; increase bust size; and remove cellulite. There is no scientific evidence to support these claims. Low‑intensity electrical stimulation can help relieve muscle soreness and can speed recovery. ENS/EMS de- vices have FDA approval for use in physical therapy by trained health practitioners for relaxing muscle spasms, preventing clots in leg muscles of patients bedridden after surgery or a stroke, increasing circulation to a part of the body, increasing or monitoring the range of mo- tion of an arm or leg, and retarding or preventing muscle atrophy resulting from disease or injury.27
ENS/EMS devices can cause electrical shocks and burns. They should not be used by pregnant women or by persons with heart problems (especially those with a pacemaker), cancer, or epilepsy. Electrodes should not be placed where strong current passes through the heart, brain, or spinal cord. The QuickGym/ROM Machine. Ads for the Quick- Gym/ROM machine promise that users will “benefit, at home, from 4 minutes a day on the ROM as you can from 20 to 45 minutes of aerobic exercise plus 45 minutes of weight training plus 20 minutes of stretching at the gym. The device, which weighs 405 pounds and retails for $14,615, is claimed to put many muscles through a large range of motion while simultaneously providing anaerobic muscle‑building, and aerobic exercise. How- ever, Hall28 notes that (a) studies the marketers provide to support their claims actually fail to support them, (b) the recommended activities are too strenuous and could injure some people, and (c) 4 minutes is not enough for an effective workout.
exerCise FaCilities
Health clubs and fitness centers are popular because they provide equipment, an opportunity for social in- teraction, and a structured program. These range from small storefront exercise rooms to clubs that provide high‑tech exercise machines, a gymnasium, a swimming pool, racquetball and tennis courts, whirlpool, sauna and steam facilities, and even an indoor track. Some clubs offer individual instruction from a personal trainer and seminars on topics such as nutrition, stress manage- ment, weight control, and smoking cessation. The cost of membership usually includes an entry fee (typically $50 to $100) plus monthly fees (typically $35 to $40), but some cost considerably more. Fees are often reduced for long‑term contracts. However, it is not advisable to sign a lengthy contract before determining that the facil- ity will meet one’s needs. The following questions can help in selecting an exercise facility:
• What is the nature of the facility and equipment (types, condition, maintenance, sufficient for peak times, time limits on use)?
• Do the locker rooms, showers, bathrooms, and whirlpools show signs of neglect or poor sanitation?
• Will the program serve my purposes? Is it designed to meet individual needs?
• What are the costs (entry fee, rates, additional charges)? • Is it conveniently located? • What is the nature of the staff (are their qualifications
adequate; are they pleasant, friendly, courteous, attentive, certified by reputable organizations)?
• Is there a system to assess fitness and help evaluate progress toward a goal, and is this clearly identified?
• Is the contract understandable? Can I take it home to read? Can I get a refund if I cancel? Can I bring guests?
• Are high‑pressure tactics used to get me to join? • Does a local Y or a competitor provide appropriate facilities
at a lower cost? • Are there members I can contact as references? • Is the club well‑established? (Check with the local Better
Business Bureau or consumer protection agency about complaints.)
• Can the services be sampled before purchasing a membership?
Consumer Problems People seriously interested in joining a health club should be wary of promotional gimmicks. Prospective members may be subjected to a sad commentary on the state of their physique and appearance, promised radiant results from the use of equipment, and offered a contract con- taining doubletalk. Other abuses include (a) misleading
Chapter Thirteen Fitness Concepts, Products, and Services 277
advertising, (b) high‑pressure sales, (c) misrepresenta- tion in sales presentations, and (d) collection practices that harass the customer. These suggestions can help you to decide whether to sign a contract:
• Ask members and former members their opinions of the club and its programs. If necessary, names can be obtained from the organization. If the club refuses to comply, be wary.
• Think it over for a few days; a reputable club will not press for an immediate decision.
• Read the contract carefully or get a knowledgeable person to read it to be sure you understand the provisions.
• Ask for a short‑term trial program. • Understand what happens if you are unable to use the fa-
cilities temporarily or decide to cancel the contract. Under some contracts, an individual could be responsible for the full contract price—even if the facilities are never used. An ideal arrangement provides a refund based on the proportion of time used during the contract period. A few clubs permit transfer of the membership but charge a fee for this.
• Be sure to determine whether the equipment you want to use is likely to be available at the times you would like to use it.
Individuals who believe that they have been dealt with unjustly or improperly pressured into joining by a health club can seek help from local or state consumer affairs office, state attorney general, county district at- torney, or small claims court. The quality of instructors or supervisory personnel at these various facilities should be reviewed carefully. Employees without adequate credentials may be call- ing themselves exercise leaders or specialists, personal trainers, or even exercise physiologists. In addition to checking credentials, it is desirable to check references and observe the person helping others.
Hot Tubs and Whirlpools Hot tubs and whirlpools increase blood flow by increas- ing the circulation of blood to body parts, thereby helping heal some injury problems. They may also help to relax muscles and reduce tension. The usual 100° to 104°F temperature makes them unsuitable for use by people with high blood pressure and related heart problems. Hot tubs and whirlpools may be hazardous unless certain educational programs and environmental con- trols are provided. They are high‑risk drowning sites for young children. Data from the National Electronic Injury Surveillance System database indicate that from 1990 through 2007, more than 81,000 people with hot tub‑related injuries were treated in U.S. emergency de- partments. The problems included slips and falls, hits and scrapes, overexertion, near‑drowning, jumping or diving, and suction.29 The Association of Pool & Spa Professionals30 pro- vides these warnings and safety tips: (a) children in or near a hot tub should always have adult supervision and should be warned not to jump or dive into the tub; (b) if there is a cover, it should be completely removed; (c) the temperature should be checked prior to use; (d) preg- nant women and people with cardiac or blood pressure problems should check with their doctor before using a hot tub; (e) fingers and hair should never be positioned near the drains; (f) a hot tub should never be used while or after using alcohol or sedating drugs; and (g) don’t soak for more than 15 minutes in 104o F water. Failure to adequately maintain the pH and chlorine content of the water can lead to outbreaks of Pseudo- monas aeruginosa folliculitis, a superficial infection of the hair follicles. Hot tub folliculitis becomes noticeable within several hours to 2 days of prolonged contact with contaminated water. It begins as itchy bumps, some of which may be filled with pus. It may then develop into dark red tender nodules. The rash may be more dense in the areas under the swimsuit where the material has held the water in contact with the skin.
Saunas Saunas include portable contrivances and built‑in rooms that emit dry heat that raises body temperature, thereby causing profuse sweating. They are located in homes, health clubs, and elsewhere. Traditionally popular in Finland, they have proliferated in Europe and the United States. Their popularity is undoubtedly related to people’s interest in health and to benefits they expect from applying heat (and cold) to the body. Advertisements have claimed that saunas help reduce weight sensibly, clear acne and other skin blem- ishes, promote fitness, and cure arthritis and bursitis.
Consumer Beware In San Francisco a nonmember was invited to spend an evening at a health club. He was allowed and encouraged to use every machine available. After 2 hours he was taken to a small room and subjected to a high‑pressure sales pitch, while another spa employee locked the door to the building and left. Reluctantly, the young man signed a $349 contract. He later learned that he had signed a bank draft for the full amount of the contract to be withdrawn immediately from his bank account. Fortunately, the consumer action office in the city was able to have the contract rescinded.
Personal Glimpse
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Some weight is lost when people perspire, but it is quickly replaced when water or other fluids are con- sumed. Acne involves the oil‑producing sebaceous glands, not the sweat glands (see Chapter 18). Sweating does not “cleanse” the sebaceous glands. Soap and water probably do as much for acne and blemished skin as the increased heat. There is no indication of how fitness improvement could take place. Some people may find that heat provides temporary relief of arthritis pain, but it is not curative. Saunas are not recommended for people with heart or respiratory problems. There are several other dangers, including heat stroke caused by the body’s absorption and storage of heat and by dehydration. The maximum exposure to a sauna should be 15 minutes. Portable sauna devices may be purchased for $200 and up. Sauna rooms cost several thousand. “Sauna shorts” (about $25) have been claimed to retain body heat when worn, creating sauna‑like warmth that causes reduction of the underlying area. This claim is fraudulent.
Home Equipment There are several less costly alternatives to joining a health club. Local Y organizations have programs with membership fees around $300 yearly. Local schools and recreation centers may offer sports, exercise, and physical education programs. Another alternative is a home mini‑gym. Expensive equipment is not required to achieve fitness. With some ingenuity, simple equipment can be assembled and many exercise activities can be performed. Used equipment may also be suitable. The equipment chosen can be selected according to one’s goals and budget:
minimum level: For less than $100—include a jump rope, a sit‑up bar to fit under any door, a padded mat on which to perform calisthenics, and a 16‑pound adjustable‑free dumbbell set.
intermediate level: For $250 or more—supplement the minimum‑level equipment with a stationary bicycle, 100 pounds of weights with long and short bars, a weight bench with a leg lift, and a videotaped exercise program.
HigH level: For $500 to $2000 or more—include a treadmill, ski‑exerciser, stair climber, or rowing machine for aerobic conditioning and a multipurpose machine for strength training.
Martial arts training
Karate, taekwondo, judo, and other martial arts can provide an enjoyable alternative to traditional exer- cise. They can contribute to aerobic capacity, balance,
strength, flexibility, and lowering of body‑fat percentage. They may also promote relaxation and self‑esteem. As with many other types of sports, injuries can occur, the most common of which are sprains, strains, and bruises. Woodward31 advises prospective students to visit sev- eral schools to decide which program and instructor fit their needs best. He also cautions participants to wear appropriate protective gear and have close supervision by qualified instructors.
Children’s exerCise Centers
Some community centers, health clubs, and local Y’s operate exercise centers for children. Parents and oth- ers considering their use should raise certain questions:
• Are the facilities appropriate to replace or augment free or partially free programs provided by schools, community centers, recreation and parks programs, and others?
• Are they necessary? • Who determines the risks involved in use of the equipment
and participation in the programs? • Are they too advanced for some children? • Are children being pushed into regimented and possibly
harmful programs during their growth and development stages in life?
• Has the equipment been constructed with children’s safety in mind?
Cook and Leit32 state:
Owing to an increase in children participating in competitive organized sports, there is a real concern for the health and well‑being of the individual pediatric athlete. . . . Children are not small adults. They not only have a different physiologic response to exercise, but also have many cartilaginous growth areas that are susceptible to injury. Appropriate training in the pediatric athlete will help prevent injury. Conservative training programs, completed in a well‑ventilated and air‑conditioned area, are important. In the prepubescent, efforts should be made to make training fun, with emphasis placed on skills important to the sport rather than monotonous repetitions and intensive conditioning.
The American Academy of Pediatrics has issued strength‑training guidelines for children (after age 8) and adolescents but cautions that young people will generally benefit more from practicing and perfecting skills of their sports.33
exerCise While traveling
Many exercise opportunities are available to travelers. It may be advisable to plan ahead to take advantage of them. Many hotels provide exercise equipment and/or a swimming pool. If not, local facilities may be available.
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Walking, jogging, and stair climbing can be done without special equipment or facilities. When traveling by plane, bus, or train, isometric ex- ercise while sitting will provide limited muscle activity. Periodic standing, stretching, or walking is advisable. When traveling by car, occasional stops to walk or stretch can be beneficial.
exerCise and Weight Control
To lose 1 pound of fat, it is necessary to metabolize about 3500 more calories than are consumed. The weight‑ loss process can be speeded up by reducing daily food intake or increasing the number of calories burned. For example, deleting 100 calories of food daily from the regular amount ingested will enable a person to lose 1 pound after 35 days (see Table 12‑4, page 247). In- creasing activity to burn an additional 100 calories daily will also achieve the same results. Someone who walks for 30 minutes daily (7.1 calories per minute) will burn 213 calories. If caloric intake is not increased, about 2 pounds will be lost per month. The amount of fat loss is determined by the total calories expended in exercise rather than its intensity. Note, however, that exercise is more important for maintaining a healthy weight than for losing weight per se.
nutrition For athletes
A well‑balanced diet is an essential component of any fitness or sports program. A good mix would contain 50% to 60% carbohydrates, 20% to 30% fat, and 15% to 20% protein. There is little reason for the dietary pattern of a physically active person’s diet to differ from what is good for other healthy persons. The American Dietetic Association34 advises:
• Physical activity, athletic performance, and recovery from exercise are enhanced by optimal nutrition.
• During times of high physical activity, energy and mac- ronutrient needs—especially carbohydrate and protein intake—must be met to maintain body weight, replenish glycogen stores, and provide adequate protein to build and repair tissue.
• Fat intake should be sufficient to provide the essential fatty acids and fat‑soluble vitamins, as well as contribute energy for weight maintenance. Consuming ≥20% of energy from fat does not benefit performance.
• Consuming adequate food and fluid before, during, and after exercise can help maintain blood glucose during exercise, maximize performance, and improve recovery time.
• Athletes should be well hydrated before exercise and drink
enough fluid during and after exercise to balance fluid losses.
• Sports drinks containing carbohydrates and electrolytes may be consumed before, during, and after exercise to help maintain blood glucose concentration, provide fuel for muscles, and decrease the risk of dehydration and low blood sodium levels.
• Body weight and composition can affect exercise perfor- mance but should not be used as the sole criteria for sports performance; daily weigh‑ins are discouraged.
• Vitamin and mineral supplements are not needed if adequate energy to maintain body weight is consumed from a vari- ety of foods. However, supplements may be required by athletes who restrict energy intake, use severe weight‑loss practices, eliminate one or more food groups from their diet, or consume high‑carbohydrate diets with low micronutrient density.
• Nutritional “ergogenic” aids should be used with caution, and only after careful product evaluation for safety, efficacy, potency, and whether or not it contains a banned or illegal substance.
The energy needs of people who engage in vigor- ous activity range from 3000 to 6000 calories per day or more. Complex carbohydrates should compose 50% to 55% or more of their diet. A diet too low in carbo- hydrates prior to strenuous exercise can cause fatigue. The pregame meal should be completed 31/2 to 4 hours before competing and should be high in complex carbo- hydrates. Fats and proteins, which require more time for digestion, should be avoided to prevent stomach upsets or indigestion that will affect performance. Carbohydrate loading is a regimen that combines high‑carbohydrate eating with gradual tapering of ex- ercise activity. Used to temporarily increase the amount of muscle glycogen, it is beneficial only to participants in lengthy endurance or multiple‑event competitions. Endurance athletes may need to increase their protein intake above the RDA of 0.8 per kg (54 g for a 150‑pound man). The Tufts University Diet & Nutrition Letter35 states that protein intake should be 95 g for a 150‑pound man, but notes that “most athletes eat more food than nonathletes, so their higher protein needs are met automatically.” Some vitamin manufacturers suggest that strenuous physical activity increases the need for vitamins so that people who engage in vigorous exercise or athletics should take supplements. Strenuous exercise does in- crease the need for calories, water, and a few nutrients. However, the nutrient needs are unlikely to exceed the RDAs. Even if above‑RDA amounts were necessary, they would be supplied by the increase in food intake normally associated with exercising.
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The belief that extra vitamins are useful to athletes is also tied to the idea that extra vitamins provide ex- tra energy—which is untrue. Above‑RDA amounts of vitamins and minerals may be needed by people who exercise vigorously, but they, too, will be supplied in a balanced diet containing extra calories. Thus vitamin, mineral, and protein supplementation are unwarranted for people who eat properly. Table 13‑8 discusses a variety of other exercise‑nutrition myths.
Sports Bars Sports bars (also called “energy bars”) typically cost cost between $1 and $2.50 and contain between 100 and 300 calories, mostly from carbohydrates. Sports nutritionist Nancy Clark, R.D., states that people who exercise at an intensity that can be maintained for more than 30 minutes may benefit from consuming up to 400 calories plus 8 to 16 ounces of water before or during such exercise. She points out, however, that the same result can be achieved less expensively by eating low‑fat granola bars or standard foods such as bananas or raisins.36 Consumer Reports37 evaluated 24 “energy bars” and concluded:
Bar foods do indeed provide energy, although that’s just a fancy word for the calories derived from protein, carbohy- drates, and fats that our bodies burn to fuel activity. As for using a bar to fuel exercise sessions, most of us don’t work out intensely enough to need more protein or carbohydrates (not to mention fats) than we get in our ordinary diet. . . . If you need an energy boost during the day, or before or after an exercise session, bars won’t do anything for you that ordinary food won’t do. And real food is apt to be more satisfying.
Sports Drinks Americans spend over $5 billion a year on sports drinks such as Gatorade, Exceed, and Quickick, with the belief that the calories and minerals they contain will help with fatigue and dehydration. Proper hydration is essential for athletic performance. Extreme exercise levels, prolonged strenuous activity, and hot weather may warrant a low‑ dose electrolyte‑replacement beverage during endurance competition.38 However, cool water can be used to meet the needs of most people who exercise in moderate cli- mates. Consumer Reports on Health39 has noted:
• For most people, sports drinks are no better than water. • Sugars in the drinks are supposed to maintain high levels of
blood sugar to prevent fatigue; however, it takes 11/2 hours of strenuous exercise to deplete energy resources.
• Deliberate replacement of lost electrolytes (primarily so- dium) is not necessary for moderate exercise if a person
has a normal diet. In very hot weather a pinch of salt added to meals for a few days will adequately provide for body needs.
• These drinks may taste good and cause more to be ingested than needed.
• People running marathons or involved in intense exercise for hours may benefit from a sports drink to bolster sugar levels and replace electrolytes.
The American Academy of Pediatrics40 has con- cluded that sports drinks can help young athletes engaged in prolonged, vigorous physical activities, but in most cases they are unnecessary on the sports field or in the school lunchroom. “Super oxygenated” beverages such as Aqua Rush, ServenRich, and AquOForce are claimed to contain dissolved oxygen that can freshen breath, increase energy and stamina, and ward off fatigue. Such claims are fool- ish because oxygen taken into the stomach is unlikely to get into body circulation and the tiny amounts involved would not affect body function even if they did. Re- searchers at the University of Wisconsin who tested 12 young men and women found that drinking Aqua Rush had no measurable effect on the their heart rate, blood pressure, or blood lactate values either at rest or during exercise tests. The researchers also tested two products and found that they actually contained less oxygen than did tap water.41 Breathing is the only effective way to supply the body with oxygen.
Energy Drinks Americans are spending about $9 billion a year for so‑ called “energy drinks” touted to rapidly increase energy, endurance, and performance. The main ingredient is caf- feine, with 3 to 5 times as much as in cola drinks. The ingredients include sugar and herbal extracts, including some that contain caffeine that may not be specified on product labels. Although the FDA limits the caffeine content of soft drinks (which are regulated as foods), it does not regulate the contents of energy drinks that are classified as dietary supplements. Seifert and others43 have concluded that energy drinks have considerable potential for toxicity due to the high amounts of caffeine and related substances (e.g., guarana) whose caffeine content need not be listed on product labels. Higgins and others44 have warned that although one can of an energy beverage during one session is safe for most healthy individuals, excess consumption and consumption with other caffeine‑containing beverages or alcohol may lead to adverse effects and possibly death.
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anaboliC steroids
Anabolism is the phase of metabolism in which the complex materials of the body are built up from smaller simpler compounds (e.g., proteins from amino acids). Anabolic androgenic steroids are male hormones, avail- able by prescription, that have legitimate medical uses for certain types of anemias, hereditary angioedema, protein anabolism, and certain gynecologic conditions. They are also useful as an adjunct to growth hormone therapy and for treating osteoporosis. The use of steroids has been widespread among
weightlifters, shotputters, discus throwers, football players, and participants in other sports where strength is required. Use has also been associated with endurance sports such as Nordic skiing, cycling, and distance run- ning. Steroids have been used by both professional and collegiate athletes. The doses used by athletes are gener- ally much higher than those used for medical purposes. Many steroid abusers achieve high dosage by combining several different brands, a practice called “stacking.” Steroids are obtained illegally from physicians who prescribe them knowing that they will be used by ath- letes and from drug dealers and other illicit nonmedical
exerCise and nutriton: MYths vs. FaCts
Table 13-8
Myth No pain, no gain.
Muscle will turn into fat if you stop exercising.
Vitamin supplements provide extra energy.
Drinking liquids during exercise causes cramps.
Excess weight can be sweated off.
Extra protein intake helps build stron- ger muscles.
Exercise can backfire for someone trying to lose weight because it increases appetite and thereby leads to overeating.
Sugary foods eaten before or during a workout supply quick energy.
Spot‑reducing causes more fat to be lost from that area than from the rest of the body.
“Sports drinks” are the best kind of fluids for exercisers.
Women who participate in strength‑ training develop oversized muscles.
To exercise effectively, people have to be athletic.
Exercise makes people tired.
Facts Health benefits are achievable by exercising moderately. Almost any
activity has benefits. Some soreness is inevitable with programs that produce high levels of fitness, but this does not justify pain from over- use of pushing oneself too hard.
Muscles grow weaker and become smaller through disuse, but they do not turn into fat.
Vitamins do not provide energy; they help regulate body processes and are readily obtainable from food.
Cool drinks of water are advisable during and after exercise to replace lost fluids.
Perspiration sheds fluid, not fat; the weight lost due to perspiration is quickly regained when the body is rehydrated.
Excess protein is stored as fat; muscle‑building comes through “resis- tance” exercising such as lifting weights.
Moderate exercise does not increase appetite. It mobilizes stored glyco- gen and decreases hunger. Only extended physical activity increases appetite.
Foods eaten just before exercise mobilize the glycogen‑storing mecha- nism of insulin, thus reducing blood glucose and temporarily impair- ing performance.
Fat lost generally comes from deposits throughout the body. There is no such thing as “spot‑reducing.”
The best beverage is plain water. If electrolytes are lost, they can be re- placed by eating food. In extremely warm weather a bit of salt should be added to the water. Many sports drinks contain salt but are need- lessly costly. Ingesting salt without water increases dehydration.
Muscle strength is increased, but not necessarily size; male hormones are the reason that men are more prone to muscle enlargement.
Most physical activities require no athletic skills. Walking provides a perfect example of this fact.
Most people feel more energetic as they become more fit.
Source: Modified from Tufts University Diet & Nutrition Letter42
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channels. The federal Anti‑Drug Abuse Act of 1988 provides penalties for those who distribute steroids or have steroids in their possession with the intent to dis- tribute them. The Act also authorizes jail sentences of up to 6 years for convicted dealers. The Anabolic Steroid Control Act of 2004 banned over‑the‑counter steroid precursors and increased the penalties for making, sell- ing, or possessing illegal steroid precursors. Studies show that muscle size and strength can be increased when steroids are used by those who are already training intensively and who combine this ac- tivity with a high‑protein and high‑calorie diet.45 Body weight is also increased, although much is due to fluid retention. Steroids can increase energy and the ability to train more intensely with a shortened recovery period, allowing more frequent training. Many athletes report that large doses result in euphoria, lack of fatigue, greater self‑confidence, and enhanced appearance. However, adverse effects include acne, genital changes, jaundice, stunted growth, sterility, liver tumors, abdominal pains, diarrhea, muscle cramps, headache, bone pains, depres- sion, breast development in men, gallstones, high blood pressure, coronary heart disease, and kidney disease.
Women who abuse steroids can develop menstrual irregularities, permanent enlargement of the clitoris, lowered voice pitch, facial hair, increased body hair, decreased breast size, and male‑pattern baldness. Taken before puberty, anabolic steroids can stop bone growth and cause permanent stunting of growth. Steroid use may cause aggressive behavior in previously nonaggressive men and women or increase aggressiveness in those who tend toward aggression.47
In 2009, the FDA48 issued a public health advisory recommending avoidance of bodybuilding products marked as containing steroids or steroid‑like substances. The advisory noted that the FDA has received reports of serious liver injury, stroke, kidney failure, and pulmonary embolism (blockage of an artery in the lung).
other “ergogeniC aids” Many athletes use substances that they hope will enhance their performance. So far, only three have been proven useful: caffeine, creatine, and sodium bicarbonate. Creatine is widely used among athletes wanting to build muscle and enhance recovery. It has been shown to be effective in repeated short bursts of high‑intensity activity in sports such as sprinting and weightlifting but not for endurance sports such as distance running. The most common adverse effects are weight (fluid) gain, cramping, nausea, and diarrhea. Although widely debated, creatine is generally considered safe for healthy adults, despite anecdotal reports of dehydration, muscle strains/tears, and kidney damage. The effects of long‑ term use of creatine supplements are unknown.34
Caffeine can prolong the duration for which exercise intensity can be maintained in endurance events and sports involving high‑intensity activity lasting from 1 to 60 minutes.49
Sodium bicarbonate may help prevent fatigue by acting as a blood buffer, but it can also cause diarrhea.50
Dubious Products Many companies are marketing concoctions of vitamins, minerals, amino acids, and other ingredients with false claims that they can increase stamina and endurance and help build stronger muscles. Many of these products are touted as “natural steroids” or “growth‑hormone releasers,” which they are not. Very high doses of certain amino acids have been reported to influence hormone production in laboratory animals. But no such effect from low‑dose pills has been demonstrated in humans. Ads for these products typically contain an endorsement from a champion athlete or bodybuilder who attributes success to the products. Some ads contain explicit claims, whereas others rely on images to convey their message (see Figure 13‑4). Some of the products are also marketed as weight‑loss aids (see Chapter 12). Gamma
Breathing Oxygen Breathing oxygen before running, swimming, or cycling cannot improve sprint performance. At rest, blood leav- ing the lungs is nearly saturated with oxygen. Breathing pure oxygen can slightly raise the arterial oxygen level. By the time the athlete moves to the starting point and the race begins, however, body oxygen stores return to normal. Thus there is no physiologic advantage.
√ Consumer Tip
Steroid Advice Although it may be true that in combination with in- tensive weight training and a high‑calorie, high‑protein diet, steroids can augment short‑term muscle gain, teens need to ask themselves: Is it worth all the short‑term health effects and the possibility of long‑term permanent damage? Is it worth the disgrace of being eliminated from competition, or even of being arrested? Raja Mishra46
√ Consumer Tip
Chapter Thirteen Fitness Concepts, Products, and Services 283
hydroxybutyrate (GHB) and clenbuterol—both of which can be deadly—have also been marketed as “steroid alternatives.” The joint position statement of the American College of Sports Medicine and the American Dietetic Associa- tion concludes that the majority of ergogenic aids do not perform as claimed. The ineffective ingredients include amino acids, bee pollen, branched chain amino acids, carnitine, chromium picolinate, cordyceps, coenzyme Q10, conjugated linoleic acid, cytochrome C, dihydroxy- acetone, F‑oryzanol, ginseng, inosine, medium‑chain triglycerides, pyruvate, and vanadium.34
In 2009, the British Journal of Sports Medicine51 began publishing a monthly series of brief reviews that ultimately will cover more than 100 purported ergogenic aids in approximately alphabetical order. So far, the vast majority of evaluations have been negative. David Lightsey, an exercise physiologist and nutri- tionist who coordinated the National Council Against Health Fraud’s Task Force on Ergogenic Aids, has re- quested written substantiation from more than 100 com- panies that market “ergogenic aids.” Fewer than half sent anything, and the rest submitted studies that were poorly designed or did not actually support product claims. Lightsey also checked statements that various teams were using certain products and found the management
had neither endorsed the products nor encouraged their use.52 Lightsey believes there are two reasons why many athletes believe that various products have helped them: (1) use of the product often coincides with natural im- provement due to training and (2) increased self‑confi- dence or a placebo effect inspires greater performance. Any such “psychologic benefit,” however, should be weighed against the dangers of misinformation, wasted money, misplaced faith, and adverse physical effects— both known and unknown—that can result from mega- doses of nutrients. Consumer Reports54 has concluded that supplemen- tary androstenedione provides no benefit for athletes and can have serious side effects. People produce andro- stenedione naturally during the making of testosterone and estrogen. When consumed by mouth, it is converted to testosterone and estrogen. The potential long‑term consequences of androstenedione use by men include decreased testicle size, impotence, and the development of female characteristics such as breast enlargement. Women users may develop male characteristics such as male pattern baldness, deepening of the voice, in- creased facial hair, abnormal menstrual cycles, abnormal menstrual bleeding, blood clots, and increased risk for breast cancer and endometrial cancer. Children who use
Figure 13-4. Ads from the leading bodybuilding magazine (Muscle & Fitness). Although these ads make no explicit claims, they falsely imply that the products were the key to success.
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these products are at risk for puberty beginning earlier and bone growth stopping prematurely. In 2004, the FDA warned 23 dietary supplement marketers to stop distributing “andro” supplements.55 The Medical Commission of the International Olympic Committee56 has warned athletes that many “supplement” products contain hormone precursors that could damage their health and/or disqualify them from competing. Its tests of 634 samples found that 94 (14.8%) contained hormone‑related substances, not listed on any label, that would have led to a positive “doping” test. Of the 94 samples, 23 contained precursors (building blocks) of both nandrolone and testosterone, 64 contained precursors of testosterone alone, and 7 contained precursors of nandrolone alone. In addition, 66 others (10.4%) contained borderline amounts of vari-
ous unlabeled substances. The products were gathered from 215 providers in 13 countries from October 2000 to November 2001. Ninety‑one percent of them were purchased in stores or over the Internet. The rest were obtained from the manufacturers. Under the Olympic Movement’s rule of strict liability, athletes are respon- sible for whatever substances are found in their body. Williams57 has pointed out that if any of the “dietary supplements” marketed as “ergogenic aids” were proven effective, their use by competitive athletes might be considered unethical.
suMMarY
Regular exercise can increase strength, endurance, flex- ibility, motor fitness, and cardiorespiratory efficiency. It
Bernarr Macfadden (1868–1955), an early proponent of exercise, advocated a variety of strange practices as well. During his youth he supposedly was sickly and unable to walk. At age 15 he discovered the gymnasium and began developing his body. He had little exposure to school before working as a physical education instructor at a school in Illinois. Macfadden launched Physical Culture magazine in 1899 and developed a publishing empire that made him a multimillionaire. Concern for physical culture was timely, since there was a growing distrust of patent medicines and the health‑reform movement advocated a simpler, more natural form of hygiene. Macfadden believed he had learned the true secrets of health without using scientific investigation. He advocated strenuous repetitive exercises. He concluded that health problems could be resolved by eating less and by fasting, which would give the body more time for repairs. For cancer he recommended fasting for a few days and a diet consisting of large quantities of grapes. His publishing ventures included health handbooks, romance and detective magazines, and sensationalist tab- loids. Macfadden Holdings, Inc., his corporate descendant, later published the National Enquirer, Weekly World News, True Romance, and several other monthly magazines. Interest in bodybuilding probably evolved from the strong‑man vaudeville acts of the 19th century. Bob Hoff- man (1899–1985) and Joe Weider (b. 1923) were the chief modern popularizers. Hoffman, a prominent oarsman and weightlifter, served for 32 years as the Olympic weight- lifting coach and helped found the President’s Council on Physical Fitness and Sports. Weider helped found the International Federation of Bodybuilders, which promotes
Historical Perspective
Faddist Underpinnings53
the sport worldwide and sponsors competitions. Both made fortunes publishing magazines and selling exercise equip- ment and supplement products. Both played a substantial role in spreading misinformation about protein supple- ments and other “ergogenic aids.” In articles and ads, they falsely asserted that athletes have special protein needs, that protein supplements have special muscle‑building and health‑giving powers, and that the most efficient way to get enough protein is by using supplements. In 1960 Hoffman’s York Barbell Company was charged with falsely claiming that its wheat germ oil could prevent or treat more than 120 diseases and conditions, in- cluding epilepsy, gallstones, and arthritis. A supply seized by the FDA was destroyed by consent decree. In 1961, 15 other York Barbell products were seized as misbranded. Additional regulatory actions took place in 1968, 1972, and 1974. In 1984 the FTC charged that ads for two of Weider’s amino‑acid products had been misleading. The case was settled in 1985 when Weider and his company agreed not to falsely claim that these products can help build muscles or are effective substitutes for anabolic steroids. They also agreed to pay a penalty of at least $400,000 in refunds or for research on the relationship of nutrition to muscle development. Although the claims forbidden by the FTC order no longer appear in Weider ads, similar messages appear in articles in his Muscle & Fitness magazine and are im- plied by endorsements and pictures of muscular athletes. Hoffman’s Muscular Development magazine, which has a similar structure, is now published by a subsidiary of another supplement company.
Chapter Thirteen Fitness Concepts, Products, and Services 285
can also lower blood pressure, improve blood cholesterol levels, help with weight control, help lower abnormal blood sugar levels, reduce stress, improve sleep, help prevent osteoporosis, and increase longevity. The risks of injury are greater for sedentary individuals and those who thrust themselves into activities that are either too strenuous or too prolonged. Exercises can be classified as aerobic, anaerobic, isometric, isotonic, and isokinetic. The type and amount should be adapted to the age and fitness level of the indi- vidual. A minimum program to achieve cardiorespiratory fitness should be 20 to 30 minutes, 3 days a week, at 60% to 90% of one’s maximum heart rate. Exercise equipment should be selected by consid- ering potential benefits, effects on body areas, costs, and personal suitability. Advertising claims should be regarded skeptically because many devices have little or no value. Health clubs and fitness centers are popular because they provide equipment, the opportunity for social inter- action, and a structured program. Prospective members should carefully scrutinize advertisements and contracts from these centers. Fitness usually can be achieved at home with less equipment and less expense. It also is possible to maintain an exercise regimen while traveling. Children’s centers have been established, although their value is questionable. Weight loss can be achieved only through a combi- nation of dietary changes, eating behavior changes, and regular aerobic exercise. Sports drinks and energy bars can be useful, but cool water and common carbohydrate foods can provide the same benefits at much lower cost.
The use of anabolic steroids and steroid precur- sors by athletes is dangerous. Protein supplements and concoctions of vitamins, minerals, and/or low doses of amino acids convey no athletic benefits and are a waste of money for people who eat properly.
reFerenCes
1. Exercising your options. Consumer Reports on Health 1:17, 19–20, 1989.
2. Health clubs: The right choice for you? Consumer Reports 61:27–30, 1996.
3. Lloyd GER, editor. Hippocratic Writings. New York, 1978, Penguin Books.
4. Spunt G. When Nature Speaks: The Life of Forrest C. Shaklee, Sr., New York, 1977, Frederick Fell Publishers. [Marketed by the Shaklee Corporation to its distributors.]
5. Ullyot J. Exercise and coronary disease. Healthline 3(10):1–2, 1984.
6. Maron BJ. Sudden death in young competitive athletes: Clinical, demographic, and pathological profiles. JAMA 276:199–204, 1996.
7. Franco OH. Effects of physical activity on life expectancy with cardiovascular disease. Archives of Internal Medicine 165:2355–2360, 2005.
8. 2008 Physical Activity Guidelines for Americans. Washington, D.C., 2008, U.S. Department of Health and Human Services.
9. Fletcher GF and others. Exercise standards for testing and train- ing. A statement for healthcare professionals from the American Heart Association. Circulation 104:1694–1740, 2001.
10. Kenney WL. ACSM Fitness Book, ed 3. Champaign, Ill., 2003, Human Kinetics.
11. Making workouts work. Consumer Reports 70(1):12–15, 2005. 12. Sacher D and others. Physical Activity and Health: A Report of
the Surgeon General. U.S. Washington, D.C., 1996, Department of Health and Human Services.
It’s Your Decision
1. You have never been involved in aerobic exercise, but you now believe you can improve your health through such participation. Which of the following would you do?
Reason
Enroll in a local exercise center or club _____________________________ Purchase an exercise bike or rowing machine _____________________________ Decide what you want to achieve from your exercise _____________________________ Buy a book on aerobics written by an expert _____________________________ Check exercise programs at the local Y _____________________________ Start jogging/walking 2–3 miles daily _____________________________ Visit your family physician for a physical examination _____________________________
2. You have been involved in an exercise program and want to assess whether it is the best program for you. How would you do this? Is there anyone you would seek out for help?
3. You wish to lose 10–20 pounds and believe this goal can be achieved through exercise. What type of program should you follow? Where can you find help with this decision?
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13. Herbert RD, de Noronha M. Stretching to prevent or reduce mus- cle soreness after exercise. Cochrane Database of Systematic Reviews Issue 4. Art. No.: CD004577. DOI: 10.1002/14651858. CD004577.pub2, 2007.
14. Yeung EW, Yeung S. Interventions for preventing lower limb soft‑tissue injuries in runners. Cochrane Database of Systematic Reviews Issue 3. Art. No.: CD001256. DOI: 10.1002/14651858. CD001256, 2001.
15. Blair SN. Living with Exercise. Dallas, 1991, American Health Publishing Co.
16. Ives JC, Sosnoff J. Beyond the mind‑body exercise hype. The Physician and Sportsmedicine 28(3):67–81, 2000.
17. Segal NA and others. The effects of Pilates training on flexibility and body composition: An observational study. Archives of Physical Medicine and Rehabilitation 85:1977–1981, 2004.
18. Kuramoto AM. Therapeutic benefits of tai chi exercise: A review. Wisconsin Medical Journal 105:42–46, 2006.
19. Conn JM and others. Sports and recreation‑related injury episodes in the US population, 1997‑1999. Injury Prevention 9:117–123, 2003.
20. Jones JJ and others. Managing sports‑related overuse injuries. Patient Care 30:(7):55–71, 1996.
21. 12 ways you can prevent injuries. Consumer Reports 68(6):17, 2003. 22. Evans D. How to choose a personal trainer. Quackwatch Web
site, July 30, 2008. 23. Workouts that work. Consumer Reports 64(2):31–39, 1999. 24. Zeni AI and others. Energy expenditure with indoor exercise
machines. JAMA 275:1424–1427, 1996. 25. Richards CE and others. Is your prescription of distance run-
ning shoes evidence‑based? British Journal of Sports Medicine 43:159–162, 2009.
26. Bowles K‑A and others. What are the breast support choices of Australian women during physical activity? British Journal of Sports Medicine 42:670–673, 2008.
27. Electrical muscle stimulators. FDA Web site, April 24, 2009. 28. Hall HA. 4 Minute Exercise Machine. Science‑Based Medicine
Blog, Sept 16, 2008. 29. Alhajj M and others. Hot Tub, Whirlpool, and Spa‑Related In-
juries in the U.S., 1990–2007. American Journal of Preventive Medicine 7:531–536, 2007.
30. The sensible way to enjoy your spa or hot tub. Alexandria, Va., 2007, The Association of Pool and Spa Professionals.
31. Woodward TW. A review of the effects of martial arts training. Wisconsin Medical Journal 108:40–43, 2008.
32. Cook PC, Leit ME. Issues in the pediatric athlete. Orthopedic Clinics of North America 26:(3):453–464, 1995.
33. Academy of Pediatrics Council on Sports Medicine and Fit- ness. Strength training by children and adolescents. Pediatrics 121:835–840, 2008.
34. Nutrition and athletic performance: Position of the American Dietetic Association, Dietitians of Canada, and the American College of Sports Medicine. Journal of the American Dietetic Association 109:509–527, 2009.
35. How much protein do athletes really need? Tufts University Diet & Nutrition Letter 5(8):1, 1987.
36. Clark N. Nancy Clark’s Sports Nutrition Guidebook, ed 4. Brookline, Mass., 2008, Human Kinetics.
37. Energy bars unwrapped. Consumer Reports 67(6):19–21, 2003. 38. American College of Sports Medicine. Position stand on ex-
ercise and fluid replacement. Medicine & Science in Sports & Exercise 39:377–390, 2007.
39. Does Gatorade beat water? Consumer Reports on Health 3:63, 1991.
40. AAP Committee on Nutrition and the Council on Sports Medicine and Fitness. Clinical report—Sports drinks and en- ergy drinks for children and adolescents: Are they appropriate? Pediatrics 127:1182–1189, 2011.
41. Anders M. New study investigates super oxygenated water claims. ACE FitnessMatters magazine, Sept/Oct 2001.
42. Modified from The diet/exercise link: Separating fact from fic- tion. Tufts University Diet & Nutrition Letter 6(12):3–5, 1989.
43. Seifert SM and others. Health effects of energy drinks on chil- dren and young adults. Pediatrics 127:511–528, 2011.
44. Higgins JP and others. Energy beverages: Content and safety. May Clinic Proceedings 85:1033–1041, 2010.
45. Yesalis CE, editor. Anabolic Steroids in Sport and Exercise, ed 2. Champaign, Ill, 2000, Human Kinetics.
46. Mishra R. On the teen scene: Steroids and sports. FDA Con- sumer 25(7):25–27, 1991.
47. Yesalis CE, Cowart VS. The Steroids Game: An Expert’s Inside Look at Anabolic Steroid Use in Sports. Champaign, Ill, 1998, Human Kinetics.
48. Public Health Advisory: The FDA recommends that consumers should not use body building products marketed as containing steroids or steroid‑like substances. FDA Web site, July 28, 2009.
49. Burke LM. Caffeine and sports performance. Applied Physiol- ogy, Nutrition and Metabolism 33:1319–1334, 2008.
50. McNaughton LR and others. Ergogenic effects of sodium bi- carbonate. Current Sports Medicine Reports 7:230–236, 2008.
51. BJSM reviews: A–Z of supplements: dietary supplements, sports nutrition foods and ergogenic aids for health and performance. British Journal of Sports Medicine 43:728–‑729, 807–810, 890–892, 1089–1090, 2009; 44:77–78, 297–298, 389–391, 486–470, 609–611, 688–690, 765–766, 905–907, 985–986, 1065–1067, 1202–1205, 2010; 45:73–74, 230–232, 456–458, 530–532, 677–679, 752–754, 830–831, 1005–1007, 1077–1078, 1163–1164, 1246–1248, 2011; 46:75–76, 2012.
52. Lightsey DM. Muscles, Speed & Lies.: What the Sport Supple- ment Industry Does Not Want Athletes or Consumers to Know. Guilford, Ct., 2006, The Lions Press.
53. Barrett S, Herbert V. The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods. Amherst, N.Y., 1994, Prometheus Books.
54. Sports‑supplement dangers. Consumer Reports 66(6):40–42, 2001.
55. Crackdown on “andro” products. FDA Consumer 38(3):26, 2004.
56. International Olympic Committee press release, April 5, 2002. 57. Williams MH. The Ergogenics Edge. Champaign, Ill., 1998,
Human Kinetics.
Chapter OnePart Four Chapter Fourteen
Personal HealtH and safety
The way you live profoundly affects your chance of getting certain diseases. Even so, many people seem to have the attitude that they can lead whatever kind of crazy existence they want . . . and when they get sick, simply go to the doctor and get fixed. TimoThy B. mccall, m.D.1
You can do more for your health than your doctor can . . . you can save money and time. . . . You can learn to treat many medical problems at home. . . . Most . . . visits (to the doctor) are made for relatively minor medical problems . . . as many as 70 percent of visits to the doctor have been termed “unnecessary.” DonalD m. Vickery, m.D.2
James F. Fries, m.D.
Antivaccinationists have done significant harm to the public health. Ultimately, society must recognize that science is not a democracy in which the side with the most votes or the loudest voices gets to decide what is right.
GreGory a. PolanD, m.D.3
roBerT m. JacoBson, m.D.
© 1983 medical economics
Part Four Personal Health Concerns288
People can do many things to prevent or minimize health problems. This chapter focuses on health- promotion; injury prevention; risk perception;
self-care; and the management of asthma, diabetes, high blood pressure, and other chronic conditions. It also dis- cusses information sources that can help or undermine prudent behavior.
tyPes (levels) of Prevention
Preventive approaches are typically classified in four ways:
Primary PreVenTion: Strategies to prevent or retard the devel- opment of disease. Most population-based health promotion activities are primary preventive measures.
seconDary PreVenTion: Strategies to detect and treat an exist- ing disease in its early stages before it results in significant disability.
TerTiary PreVenTion: Strategies to reduce the negative impact of established disease by restoring function and reducing disease-related complications. Includes palliative care.
quaTernary PreVenTion: Strategies to reduce or avoid the consequences of unnecessary or excessive interventions in the health-care system.
The yardsticks used to measure the effectiveness of preventive measures include death (mortality) rates, disease incidence, years of potential life lost (a measure of premature mortality), economic costs, health-related quality of life, and life expectancy.
HealtH-Promoting BeHaviors
Maintaining a healthy lifestyle can reduce the odds of becoming seriously ill and lower the cost of health care. Prudent consumers avoid tobacco products, eat sensibly,
exercise appropriately, maintain a reasonable weight, use alcohol moderately or not at all, take appropriate safety precautions, get adequate amounts of sleep, and utilize appropriate professional care. Cigarette smoking is the leading cause of prevent- able death and is a major cause of heart disease, cancer, and many other diseases (see Chapters 15 and 16).4 Exposure to environmental tobacco smoke (“passive smoking”) increases the risk of developing heart disease and can exacerbate several other diseases.5 Cigarette smoking is also an important cause of spontaneous abor- tions, low birth weight, birth defects, and infant deaths.
Most other forms of tobacco use are no safer than cigarettes.6 Bidis, kreteks, and hookahs cause more lung damage. Cigar smoking increases the risk of several types of cancer, and deep inhalation can cause heart disease. Smokeless tobacco is not as deadly, but it does cause cancer deaths and dental disease. Poor diet and physical inactivity cause nearly as many deaths as cigarette smoking.7 Healthful diets can be achieved by following the guidelines described in Chap- ter 10. Women should pay special attention to their cal- cium and vitamin D intake to decrease the risk of osteo- porosis (see Chapter 19). Regular exercise can increase strength, endurance, flexibility, and cardiorespiratory efficiency. It can also lower blood pressure, improve blood cholesterol levels, help with weight control, help lower abnormal blood glucose levels, reduce stress, improve sleep, help prevent osteoporosis, and increase longevity. Aerobic exercise is best, but even nonvigorous exercise provides significant benefit (see Chapter 13). Weight is determined by the relationship between calories consumed and energy expended by the body. Mild overweight is not harmful, but being 20% over- weight can contribute to high blood pressure and increase
• The most important aspects of self-care are maintaining a healthy lifestyle and making your personal environment conducive to health and safety.
• Excellent information sources are available to help consumers determine which problems can be self-treated and which require professional care.
• People with diabetes and high blood pressure can be treated most effectively and inexpensively with a professionally supervised program that includes in-home testing.
• Self-help groups provide opportunities to exchange information, share feelings, and network with others who have had similar experiences.
• Online support groups offer anonymity, convenience, and a rapid response, but they may also attract unsubstantiated testimonials and sales pitches for questionable products.
KeeP tHese Points in mind as you study tHis CHaPter
Key Concepts
Chapter Fourteen Personal Health and Safety 289
the incidence or risk of diabetes, heart and blood vessel diseases, osteoarthritis, and several other problems (see Chapter 12). To lose weight, one must eat less or exercise more, but most people need to do both. Moderate drinking (no more than 0.6 ounces of alco- hol for women or 1.2 ounces of alcohol per day for men) is associated with a lower-than-average risk of coronary heart disease, but higher levels of alcohol intake raise the risk for many chronic and disabling diseases as well as for social and family disruption. The Personal Glimpse box below warns about combining alcohol and caffeine. Major birth defects, including fetal alcohol syn- drome, have been attributed to heavy drinking by the mother while pregnant. Although there is no conclusive evidence that an occasional drink is harmful to the fetus or to the pregnant woman, a safe level of alcohol intake during pregnancy has not been established. Based on these observations, leading authorities recommend that women who are pregnant or trying to conceive should not drink alcoholic beverages.8 People planning to drive a car, engage in another activity that requires attention or skill, or use certain medications are also advised to abstain. Preventive medical care includes immunizations and periodic examinations to look for conditions that can be significantly influenced if detected early. The U.S. Preventive Services Task Force has published detailed information about the types of physical examinations,
laboratory tests, immunizations, counseling, and other measures that are most appropriate (see Chapter 5). Self- examination of the skin to detect cancer is also advisable. A combination of nutrition, good eating habits, oral hygiene, and professional care will enable most people to maintain their teeth in good condition throughout their life. Adequate amounts of fluoride during childhood will help make teeth resistant to decay. Daily brush- ing and flossing of the teeth can prevent tooth decay and periodontal disease. Professional care may include administration of sealants, removal of calculus (tartar), restoration of decayed or missing teeth, and cosmetic measures. These subjects are discussed in Chapter 7.
Smoking Cessation Although addiction to cigarette smoking is often difficult to overcome, more than 40 million Americans have quit, 90% of them without formal medical intervention.10 The chemical in tobacco products that produces the power- ful mental effects that reinforce tobacco use is nicotine. No matter how long a person has smoked, stopping is still beneficial. During the first smoke-free day, nicotine and carbon monoxide levels decrease in the body, and the heart and lungs begin to repair the damage caused by cigarette smoke. “Smoker’s cough” usually disappears within a few weeks, energy and endurance may increase, and the senses of taste and smell may return to normal. A decade after stopping, the risk of dying from cardio- vascular disease declines to the level of the nonsmoker. However, damage to some organs may be irreversible. Smokers seeking to quit can benefit from under- standing the extent to which withdrawal symptoms, habit, and anxiety reduction contribute to their urge to smoke and from knowing some basic strategies to help cope with each of these factors. Inexpensive educational materials and courses are available from the American Cancer Society, American Heart Association, American Lung Association, Seventh-day Adventist Church, com- munity hospitals, and other local agencies. The U.S. Public Health Service offers many publications in print and online. Most strongly motivated people can quit regardless of the method used. Many profit-oriented smoking ces- sation companies claim high success rates but do not follow-up all patients for at least 1 year; do not verify abstinence by checking for nicotine metabolites in the saliva, urine, or blood; and report on small numbers of highly selected and motivated individuals. Dunston11 has noted that (a) counseling or drug therapy (nicotine replacement therapy or other forms of medication) or combining both methods can substantially
Personal Glimpse
Caffeine + Alcohol = Trouble Caffeinated alcoholic beverages (CABs) combine al- cohol, caffeine, and other stimulants and usually have higher alcohol content than beer. The caffeine content is often not reported. Government officials have ex- pressed concern that CAB consumers—particularly young, inexperienced drinkers—may not realize how much alcohol they have consumed because caffeine can mask the sense of intoxication. O’Brien and others9 found that college students who combined alcohol and caffeine (either by using CABs or by mixing nonalcoholic “energy drinks” and alcoholic beverages) had significantly higher preva- lence of alcohol-related consequences, including being taken advantage of sexually, taking advantage of another sexually, riding with an intoxicated driver, being physically hurt or injured, and requiring medi- cal treatment. A few states have banned the sale of CABs, and more are expected to do so.
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increase the likelihood of successful smoking cessation; (b) several forms of nicotine replacement therapy and a few other drugs have been proven helpful; (c) support groups, individual counseling, and telephone counsel- ing have been shown to improve quit rates; (d) self-help materials and programs have not been documented as effective when used alone; and (e) acupuncture and hypnosis have not been proven effective. Chapter 17 discusses drug-related methods. Commercial self-help products should be regarded skeptically. Graduated filters that remove nicotine and products that guide gradual reduction of the number of cigarettes smoked daily have not been proven effective. Dietary supplements, herbs, and homeopathic products should be considered useless.
Vaccination Vaccines may be modern medicine’s greatest achieve- ment. They have saved countless lives, prevented untold suffering, and eradicated smallpox. Babies born in the United States today now have the potential to be pro- tected against 17 serious infectious diseases throughout their lifetime due to routinely recommended immuniza- tions.12 Nevertheless, there has been a backlash from misinformed parents and others who believe vaccines cause autism and do more harm than good. Autism is frequently diagnosed at about the age the first measles- mumps-rubella shot is given, so it was natural for parents to think the vaccine might be responsible. A 1998 study by Dr. Andrew Wakefield appeared to support that belief, but the study was later retracted and shown to contain falsified data (see Chapter 2). Some people blame thimerosal, a mercury-containing preservative present in some vaccines. The amount of mercury involved is trivial, but in 2002 thimerosal was removed from most U.S. vaccines as a “cautionary” measure. Removal was not followed by a fall in the incidence of autism. Many studies have found no link between autism and vaccines with or without thimerosal.13
Vaccine refusal endangers our public health by decreasing herd immunity so that preventable disease can propagate through a community.14 More and more children are getting exemptions from school vaccination requirements. As a result, there have been outbreaks of diseases that had previously been under good control, especially pertussis and measles. With air travel, a single case inadvertently brought in from another country can trigger an epidemic. Some parents argue that if a disease is not present in their community, their child is more likely to be harmed by the vaccine than by the disease. They (selfishly) want to protect their own child by letting others take the risk;
they get a free ride on the coat-tails of those who do vaccinate. Ultimately, everyone is at greater risk if the disease returns. Getting vaccinated protects others, in- cluding infants too young to get vaccines, patients who can’t be vaccinated because of immune impairments, patients with other health conditions that make them particularly susceptible to complications if they catch the disease, and the elderly, who are not as well protected by flu shots and are particularly vulnerable to complications if they get the flu.
Consumer Health Insight
Anti-Vaccine Myths Scientists have reached a consensus: there is no evi- dence of any link between vaccines and autism. But anti-vaccine organizations and activists like actress Jenny McCarthy have continued to spread fears and misinformation under the pretense that they are encouraging “informed decisions.” The myths they promote include:
• The diseases were waning anyway; vaccines had no effect. The truth: death rates were declining due to improved medical treatment, but incidence rates were not declining. Incidence dropped pre- cipitously when vaccines were introduced. It has been observed repeatedly that in areas where the vaccination rate drops, there is a resurgence of the disease, and when the vaccination rate rises again, the incidence of the disease declines again.
• Vaccines contain dangerous ingredients such as antifreeze, formaldehyde, aluminum, and aborted human fetal tissue. The truth: some of these ingre- dients are not present in vaccines; others are present in trace amounts that are harmless.
• Too many vaccines overwhelm the immune system. The truth: they don’t overwhelm it; they exercise it and strengthen its response to specific antigens. There are fewer antigens in all of today’s vaccines combined than there used to be in one smallpox vaccine. If the routinely recommended vaccines were all administered together, the immune system would need to use only about 0.1% of its capacity to process them.15
• It is safer to delay and space out vaccines. The truth: there is no evidence that delaying or sepa- rating vaccines offers any benefit, and no good rationale for expecting that it would; delay only leaves infants at risk longer and increases risk for the community as a whole.16 Thus “alternative” vaccine schedules should be disregarded.
Chapter Fourteen Personal Health and Safety 291
• Maintaining a fire extinguisher • Ensuring water quality in a home swimming pool or hot
tub • Testing for and remediating high home radon levels • Preparing all household members to deal with medical
emergencies, fires, poisoning, and natural disasters that require evacuation of one’s home or community23
indoor air Quality
The Environmental Protection Agency24 has identi- fied three general approaches to controlling indoor air pollution:
1. Source control, the most important approach, involves reducing pollution by minimizing the use of products and materials that cause indoor pollution, employing good hy- giene practices (including humidity and moisture control) and practicing good housekeeping.
2. Outdoor air ventilation using open windows, exhaust fans, and other mechanical ventilation systems is also important.
3. Air cleaning to remove airborne particles with devices using air filters or ionizers (electrostatic precipitators) is a supplemental method.
Some companies have falsely claimed that air ion- izers would provide health benefits by improving air quality. However, Consumer Reports25 has found that many of them performed poorly or emitted significant amounts of ozone gas, an irritant that can aggravate asthma and decrease lung function. Consumer Reports26 also cautions that air purifiers alone will not reduce the effect of indoor pollutants for people with asthma or allergies. The Federal Trade Commission has also been concerned about improper health claims. In 2011, it settled charges against Oreck Corporation with a consent agreement requiring the company to pay $750,000 and refrain from making unsubstantiated claims for any vacuum cleaner or air cleaning product. Oreck’s Halo vacuum cleaner, which retailed for $599.95, contained a light chamber that generated ultraviolet light. Oreck’s Proshield air cleaner, which cost as much as $399.95, uses an electrostatic charge to filter air particles. The FTC objected to claims that the products could prevent or substantially reduce the risk of flu, colds, and other illnesses caused by bacteria, viruses, molds, and allergens.27 Moisture control can also add to air quality. By add- ing moisture to room air, humidifiers can make rooms feel warmer at relatively cool temperatures, reduce throat and nasal dryness, and alleviate atopic dermatitis caused by dry air. Chapter 20 discusses these devices further.
Every argument of the anti-vaccine movement has been soundly rejected by scientific experts. Vaccines carry a very small risk of adverse effects, but they are far safer than the diseases they prevent. The Consumer Health Insight Box provides responses to several vac- cination myths. Bogus products marketed as vaccine alternatives are also a significant problem. During the past decade, the FDA has ordered more than 100 sellers to stop claiming that colloidal silver, homeopathic products, or dietary supplements are effective in preventing various infec- tious diseases.17
Sleep Adequacy Failure to get adequate sleep has been linked to motor vehicle crashes, industrial disasters, and medical and other occupational errors. Unintentionally falling asleep, nodding off while driving, and having difficulty perform- ing daily tasks because of sleepiness all may contribute to these hazardous outcomes. People with sleep insufficiency are also more likely to suffer from chronic diseases such as high blood pres- sure, diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity.18 Chapter 17 discusses this subject further.
safety measures
Another important aspect of health promotion is taking reasonable safety precautions. Prudent measures include:
• Installing and maintaining properly functioning smoke and carbon monoxide detectors19
• Appropriately storing and handling hazardous home equip- ment, toxic chemicals, and firearms
• Using properly designed and installed car safety seats for children20
• Wearing appropriate protective gear such as a helmet for bicycling and skateboarding
• Using automobiles equipped with effective safety devices such as antilock brakes, an electronic stability control system, and a backup prevention device (camera system or wide-angle rear-view lens)21
• Using proper methods of food preparation and storage. • Using “childproofing” devices such as cabinet and toilet
seat locks, stairway gates, and electric outlet guards • Installing fencing to protect children from drowning • Using proper flotation devices for boating and other water-
based recreation activities • Following recommended safety precautions for selecting
and using playground equipment22
• Affixing decals onto glass doors to prevent collisions
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Table 14-1 identifies what the National Commission of Preventive Services considers the most cost-effective services that clinicians can provide.
self-diagnosis
Everyone practices self-diagnosis to some extent. It would be impractical and a waste of medical expertise to have physicians deal with every cough, twinge, ache, and sore. However, individuals must be able to distinguish between minor and major problems to determine when professional help is needed. Most conditions appropriate for self-treatment have symptoms that are easily recog- nized, occasional, and temporary. Examples include the common cold, simple headaches, occasional indigestion, muscle aches and pains, slight burns, cuts and bruises, occasional sleeplessness, some skin infections, diarrhea, itching, and mild allergic reactions. Self-diagnosis of a serious or chronic condition is an- other matter. Both overdiagnosis and underdiagnosis can lead to trouble. For example, a person who misdiagnoses a minor ache as arthritis may become needlessly upset, or someone who assumes that shortness of breath is the result of a bad chest cold when it is actually caused by heart failure may fail to seek timely corrective treatment. Even when self-diagnosis of a serious or chronic condi- tion is correct, health may be threatened if a physician is not consulted. A physician’s therapeutic resources far surpass any that are available to a layperson. The FDA’s classic survey of health practices and opinions asked nearly 3000 randomly selected adults whether they had ever had various serious ailments and who had diagnosed them. Almost everyone who reported heart trouble, high blood pressure, and diabetes had been diagnosed by a physician. But a sizable percentage of those reporting arthritis (20%), asthma (22%), allergies (28%), and hemorrhoids (32%) had made the diagnosis themselves without consulting a health professional.32
People are less likely to recognize or seek help for illnesses that develop slowly, whereas illnesses with acute symptoms, such as severe abdominal pain, high fever, or excessive bleeding, are more easily recognized and brought to the physician’s attention. The reasons for not seeking needed medical care include:
• Concern about cost • Fear of being told that you are seriously ill or need
surgery • Inability to recognize symptoms of illnesses • Fear of embarrassment • Distrust of the medical profession • Cultural, language, and literacy barriers • Apathy about your health
risK PerCePtion
People are most likely to take steps to take care of themselves when they perceive that doing so will reduce important health and safety hazards. But risk-communi- cation expert Peter M. Sandman, Ph.D.,28 has concluded:
If you make a list of environmental risks in order of how many people they kill each year, then list them again in order of how alarming they are to the general public, the two lists will be very different. . . . The risks that kill you are not necessarily the risks that anger and frighten you . . . . To the experts, risk means expected annual mortality. But to the public (and even the experts when they go home at night), risk means much more than that. Let’s redefine terms. Call the death rate (what the experts mean by risk) “hazard.” Call all the other factors, collectively, “outrage.” Risk, then, is the sum of hazard and outrage. The public pays too little attention to hazard; the experts pay absolutely no attention to outrage. Not surprisingly, they rank risks differently.
Sandman further notes that outrage is more likely to occur when (a) the threat is exotic rather than familiar, (b) a dreaded disease such as cancer or AIDS is involved, (c) the situation is perceived as immoral, (d) government officials or industry leaders fail to make full disclosure, (e) the problem affects people at once rather than over a long period of time, and (f) risk reduction depends on the government rather than the individual. Media reports can greatly influence what people perceive as hazardous. For example, at various times, the media have promoted widespread fears that cellular phones, video display terminals, coffee, electric blan- kets, the artificial sweetener saccharin, commercial hair dyes, and potato chips pose serious risks. The American Council on Science and Health29 has noted that all of these scares were based on “questionable, hypothetical, or nonexistent scientific evidence.” FDA scientist Robert Scheuplein30 has noted that “scientists, managers and regulators who study risks for a living are constantly dismayed because the public seems to worry about the wrong risks.” One example of inverted priorities involves radon, a cancer-causing radioactive gas that occurs naturally in rocks and soil that contain uranium and seeps into many people’s basements. Despite widespread publicity of the hazard in New Jersey, consumers responded with apathy. Yet when state officials tried to dispose of dirt containing radon-emitting industrial waste from an old paint fac- tory by mixing the contaminated soil with regular dirt and dumping it in an abandoned quarry, angry citizens protested and blocked the action.31
Overall, the risk-avoidance measures recommended in this chapter offer far more protection than many of those suggested by news stories.
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Services Description CPBa CEb Totc
Aspirin Chemoprophylaxis Discuss daily aspirin use with men 40+, women 50+, and others at increased risk for heart disease for the prevention of cardiovascular events
5 5 10
Childhood Immunization Series
Immunize children: Diphtheria, tetanus, pertussis, measles, mumps, rubella, inacti- vated polio virus, Haemophilus influenzae type b, hepatitis B, varicella, pneumo- coccal conjugate, influenza
5 5 10
Tobacco Use Screening and Brief Intervention
Screen adults for tobacco use, provide brief counseling and offer pharmacotherapy 5 5 10
Colorectal Cancer Screening Screen adults 50+ years routinely with fecal occult blood test, sigmoidoscopy, or colonoscopy
4 4 8
Hypertension Screening Measure blood pressure routinely in all adults and treat with anti-hypertensive medication to prevent the incidence of cardiovascular disease
5 3 8
Influenza Immunization Immunize adults aged 50+ against influenza annually 4 4 8 Pneumococcal Immunization Immunize adults aged 65+ against pneumococcal disease with one dose for most 3 5 8 Problem Drinking Screening
and Brief Counseling Screen adults routinely to identify those whose alcohol use places them at increased
risk and provide brief counseling with follow-up 4 4 8
Vision screening - Adults Screen adults aged 65+ routinely for diminished visual acuity with the Snellen visual acuity chart
3 5 8
Cervical Cancer Screening Use Pap smears to screen women who have a cervix. Screening should begin within three years after the onset of sexual activity or by age 21, whichever comes first.
4 3 7
Cholesterol Screening Screen routinely for lipid disorders among men aged 35+ and women aged 45+ and treat with lipid-lowering drugs to prevent the incidence of cardiovascular disease
5 2 7
Breast Cancer Screening Screen women aged 50+ routinely with mammography alone or together with clini- cal breast examination. Discuss with women aged 40-49 when to begin screening
4 2 6
Chlamydia Screening Screen sexually active women under age 25 routinely 2 4 6 Calcium Chemoprophylaxis Counsel adolescent and adult women to use calcium supplements to prevent fractures 3 3 6 Vision Screening - Children Screen children less than age 5 routinely to detect amblyopia, strabismus, and
defects in visual acuity 2 4 6
Folic Acid Chemoprophylaxis
Counsel women of childbearing age routinely on the use of folic acid supplements to prevent birth defects
2 3 5
Obesity Screening Screen all adult patients routinely for obesity and offer obese patients high-intensity counseling about diet, exercise or both together with behavioral interventions for at least 1 year
3 2 5
Depression Screening Screen adults for depression in clinical practices that have systems in place to as- sure accurate diagnosis, treatment and follow-up
3 1 4
Hearing Screening Screen for hearing impairment in adults aged 65+ and make referrals to specialists 2 2 4 Injury Prevention Counseling
Assess the safety practices of parents of children less than age 5 and provide coun- seling on child safety seats, window/stair guards, pool fence, poison control, hot water temperature and bicycle helmets
1 3 4
Osteoporosis Screening Routinely screen all women aged 65+ and also women aged 60+ who are at in- creased risk for osteoporosis. Discuss benefits and harms of treatment options
2 2 4
Cholesterol Screening - High Risk
Screen men aged 20 to 35 and women aged 20 to 45 routinely for lipid disorders if they have other risk factors for coronary heart disease and treat with lipid lower- ing drugs to reduce the incidence of cardiovascular disease
1 1 2
Diabetes Screening Screen for diabetes in adults with high cholesterol or hypertension and treat with a goal of lowering levels below conventional target values
1 1 2
Diet Counseling Offer intensive behavioral dietary counseling to adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease
1 1 2
Tetanus-diphtheria Booster Immunize adults every 10 years 1 1 2
Priorities among effeCtive CliniCal serviCes tHat PraCtitioners Can Provide33
Table 14-1
aCPB = clinically preventable burden; bCE = cost effectiveness; cTot = total of CPB + CE. Reproduced with permission from Partnership for Prevention.
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• Belief that illness is punishment for improper behavior • Belief that it is shameful to be ill • Lack of transportation • Too busy; unable to get away from work
A physician should be consulted when (a) a symptom or condition is too severe to be endured (e.g., severe ab- dominal or chest pain), (b) an apparently minor symptom persists for a few days with no easily identifiable cause, (c) symptoms return repeatedly for no apparent reason (e.g., digestive distress), or (d) there is doubt about the nature of the condition. If you are unsure about whether a visit is needed, contacting the doctor’s office may help. If the symptoms are outlined, the nurse or receptionist (consulting with the doctor if necessary) will advise whether a visit should be scheduled. Some health plans provide a telephone or electronic consultation service for this purpose.
Internet-Based Testing Services Some Web-based organizations offer consumers the op- portunity to order their own standard laboratory tests. After online payment, the customer goes to a desig- nated facility to have blood drawn or to leave whatever specimen is needed; or, in some cases, the company will obtain it at the customer’s workplace. Although the tests may be less expensive than those performed at standard laboratories, the process of selecting and ordering one’s own tests has several potential drawbacks. Without direct medical guidance, it may be difficult or impossible for an individual to know what tests are needed or how to interpret the results. Some testing services advertise that a physician will review the results, but this is really not a substitute for review by a physician who knows the patient. U.S. News & World Report34 has pointed out that “false security from an inappropriate test could lead a do-it-yourselfer to avoid needed care” and that “tests alone don’t add up to a good diagnosis.” In addition, insurance plans don’t pay for tests that are not “reason- able and necessary,” which makes it unlikely that the cost of self-directed tests will be covered. Some Web-based marketers invite people to mail a specimen or urine or saliva for laboratory testing that ultimately results in recommendations for dietary supple- ments or herbs. No such service should be considered trustworthy (see Chapter 11).
Dubious Genetic Testing Until recently, hereditary tendencies were determined mainly by examining the family history of the indi- viduals involved. Within the past 15 years, however, genes have been identified that cause or contribute to Alzheimer’s disease, amyotrophic lateral sclerosis (Lou
Gehrig’s disease), cystic fibrosis, neurofibromatosis, familial colon cancer, Huntington’s disease, myotonic dystrophy, and many other conditions. Many laboratories and clinics provide genetic testing and counseling, and scientific research in this field is progressing rapidly.35 Genetics is the study of single genes and their effects. Genetics tests analyze human nucleic acids, chromo- somes, proteins, and/or certain metabolites in order to detect alterations related to a heritable disorder. Tests that identify carriers of various diseases can be used to help couples decide whether or not to have children (see Chapter 19). Genetic tests can also help diagnose a few inherited diseases caused by problems with a single gene and lead to earlier treatment. Scientists hope that further research will lead to strategies for preventing or treating many more. Genomics is the study of all genes, including interactions of those genes with each other and with the environment. Many Web sites offer genetic or “genomic” testing combined with guidance on diet, supplement strategies, lifestyle changes, and/or drug usage that they claim can improve health outcomes. Most of the tests, which are marketed directly to consumers, are for common gene variations that have been linked to major illnesses (e.g., coronary heart disease) that have hereditary aspects but are heavily influenced by lifestyle factors. For some of these diseases, genetic testing may indicate that an individual is more susceptible than most people, but it cannot predict with certainty that the disease will de- velop.36 GeneWatch UK,37 which considers comprehen- sive genetic testing akin to “genetic horoscopes,” doubts that a day will come when lifestyle advice, medication, and diet can be tailored to individual genes so that the diseases people would otherwise get can be prevented. A GAO undercover study in which identical specimens were sent to several testing companies found that reports conflicted with each other and had no practical value.38
Home Medical Tests Several types of tests available in medical laboratories are available for consumers to perform at home. To gain FDA approval, such over-the-counter products must be accurate and perform at least one of three functions: (1) doctor-recommended monitoring, (2) detecting a marker for a health condition when there are no physical signs of disease, or (3) detecting a marker when signs of a condition are apparent. The manufacturer must also convince the FDA that the results can benefit consumers and that consumers will be able to judge for themselves whether the test is appropriate. The “Using Tests Wisely” Consumer Tip box provides general advice for home testing.
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managing CHroniC disease
The major conditions for which self-care can play an important role include allergies, arthritis, fibromyalgia, asthma, diabetes mellitus, high blood pressure, and irri- table bowel syndrome. In such cases, the more the patient (or the patient’s family) understands about the condition and its treatment, the greater the role they can play.
Allergies Hypersensitivity is an objectively reproducible reaction to a substance at a dose that people normally tolerate. Al- lergy is a form of hypersensitivity to a specific substance (called an antigen or allergen) that triggers specific types of immune responses. One in five Americans is allergic to something. The common allergic reactions include hay fever, asthma, hives, other skin eruptions, and allergic
conjunctivitis (itchy inflammation of the eyes). The most serious reaction is anaphylaxis, which can cause swell- ing, shortness of breath, skin rash, nausea, vomiting, loss of consciousness, and death. The immune system normally protects people from foreign substances and infectious organisms. Allergies develop when the immune system mistakes a harmless foreign molecule for a harmful one and makes antibod- ies and/or specialized cells to defend the body against it. When re-exposed to the foreign antigen, these defenses produce symptoms by releasing immune system chemi- cals such as histamine. The common allergens include:
inhaleD suBsTances: Pollens from weeds, grasses, trees, and plants; dusts in the home and in industry; mold spores; animal skin (dander) and hair; feathers; cosmetics; hair lo- tions; tobacco smoke; insecticide sprays; and many other chemicals.
FooDs: The most common food allergies are to peanuts, tree nuts, wheat, soy, fish, shellfish, eggs and milk.
suBsTances ThaT conTacT The skin: Plastics, metals (especially nickel in jewelry), latex (see Chapter 20), rubber, fabrics, dyes, cosmetics, resins, drugs, pesticides, and plants such as poison ivy (Chapter 18).
meDicaTions: Aspirin, penicillin, and many other drugs. insecT sTinGs: Bees, wasps, etc.
Many people mistakenly conclude that they have allergies. Allergies develop almost exclusively to large protein molecules. Not all hypersensitivity reactions are true allergies.39 Nonallergic hypersensitivities include food intolerances (such as lactose intolerance) in people who lack specific digestive enzymes. Food intolerances usually cause gastrointestinal symptoms and are less seri- ous than food allergies. A major review found that up to 35% of people who reported reacting to a food believed they had a food allergy, but only 2% to 5% actually did.40 It is essential to have allergies confirmed by a medi- cal professional in order to guide appropriate treatment. Skin and blood tests can help to identify suspected aller- genic substances, but test results are sometimes positive in the absence of true allergy. In most cases, the patient’s history is of equal or greater importance. Consultation with an allergy specialist may be advisable, particularly when the cause is not readily apparent. The best way to control allergies is to understand which allergens cause problems and to avoid exposure to them. Mild allergy symptoms can be self-treated. For more serious allergies, doctors can choose from a large array of effective medications, including antihistamines, corticosteroids, pills, creams, inhalers, and injections. Desensitization treatment (“allergy shots”) may be effective against some inhaled allergens, such as the
√ Consumer Tip
Using Home Tests Wisely These suggestions can help consumers who are con- sidering the use of home health tests:
• Consult with a doctor or other health-care profes- sional before buying a test, and ask which brand to purchase.
• Check the expiration date because chemicals lose their potency with time and the results could be affected.
• Store products as directed; they may be affected by hot or cold temperatures. Don’t leave a tem- perature-sensitive product in a car trunk or near a sunny car window in hot weather.
• Read labels and package instructions carefully. If questions remain, call the toll-free number if one is listed on the package or consult your doctor or the pharmacist at the place of purchase.
• Understand the limitations and purposes of the test. Remember that no test is 100% accurate.
• Follow instructions carefully. Use a stopwatch if precise timing is necessary.
• When collecting a urine specimen with a container not from a kit, wash the container thoroughly, and rinse out all traces of detergent—preferably with distilled water.
• Know what to do when results are positive, nega- tive, or unclear. It may be advisable to repeat the test or consult a physician.
• Keep test kits containing potentially poisonous chemicals or a sharp instrument out of the reach of children.
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pollens that cause hay fever or aggravate asthma, and against insect stings. However, they are not useful for food allergies. Chapter 8 discusses questionable allergy treatments. Many OTC products are available to treat allergy symptoms. Antihistamines may provide temporary relief, especially for hay fever and itching skin. Most OTC antihistamines can cause drowsiness and should not be combined with alcohol or certain medications or used when driving. Creams and lotions are available to control itching. Hydrocortisone cream is the best choice, but the strengths available without a prescription are only useful for mild cases. Nonprescription creams containing local anesthetics or antihistamines should be avoided, since they can cause sensitization to the drugs they contain. Well-informed patients can play a major role in man- aging their treatment. They should know the names of any medications to which they are allergic (many drugs have more than one name) and should make sure all of their health-care providers are aware of them; just having them recorded in the medical record is not enough. Individuals with severe or life-threatening allergies should carry some form of emergency medical identi- fication. This can be a health card to be carried in the person’s pocket, purse, or wallet or a plastic card or metal tag worn around the neck or wrist. These items should list what drugs or substances to which the patient is al- lergic. If someone is found unconscious or is seriously injured and unable to communicate, the information may be important. It is also wise to tell friends and family about allergies and make sure they know to call 911 at the first signs of a reaction. Patients who are at risk of anaphylaxis (a life- threatening emergency) should carry an epinephrine auto-injector (Epi-Pen) and know how to use it.
Asthma Asthmatics (and their families) can learn how to use medications to minimize the frequency and sever- ity of acute attacks. Asthma is a chronic lung disease characterized by reversible airflow obstruction. The prevalence is increasing; it currently affects about 7% of the U.S. population and causes over 4000 deaths a year. It typically appears as acute attacks of wheezing, shortness of breath, chest tightness, and coughing. The basic underlying cause is inflammation; both genetic and environmental factors contribute. Inflamed airways become very sensitive and react with bronchial constric- tion, swelling, and increased mucus secretion. Attacks are commonly triggered by inhaling something to which the patient is allergic, such as dust, animal dander, pollen, or chemicals. They may also be triggered by exercise,
strong emotions, cold weather, irritants like tobacco smoke, aspirin and other drugs, upper respiratory infec- tions, or occupational exposures. Not all that wheezes is asthma; there are many other causes of wheezing, ranging from inhaled foreign bodies to heart failure. Not all asthma results in wheezing. In mild cases, sometimes the only symptom is a night-time cough. In severe attacks, airflow may be reduced so much that wheezing is no longer heard. Patients should not try to self-diagnose. A proper diagnosis by a doctor is essential, with confirmation by pulmonary function tests (spirometry, peak flow measurements) and other diagnostic methods. Two categories of medication are used to treat asth- ma: quick-relief drugs for use during attacks and control drugs to prevent future attacks. Usually an inhaler or nebulizer containing a rapid-acting bronchodilator such as albuterol is used for quick relief of symptoms. These can also be used before exercise to prevent symptoms in exercise-induced asthma. For long-term control, inhaled corticosteroids and other drugs are available. Danger signs that indicate a need for emergency treatment include failure of usual medications to relieve symptoms, extreme difficulty breathing, difficulty in talking, rapid pulse, bluish discoloration of the lips or face, confusion, and drowsiness. Patient responsibilities include:
• Recognizing triggers and avoiding them. • Taking medication as prescribed. • Learning how to properly use inhalers and spacer devices. • Avoiding the temptation to over-use inhalers. • Keeping records of symptoms and medication usage. • Monitoring their disease with a home peak flow meter as
instructed by their doctor.
Arthritis Arthritis is a general term encompassing many dis- eases characterized by joint pain, inflammation, and/ or deformity. Some types are short-lived and curable, whereas others are chronic. The most common forms of chronic arthritis are osteoarthritis, rheumatoid arthritis, and gout. Osteoarthritis, the most widespread type of arthritis, is a degenerative disease of the joints. Although some- times capable of causing acute inflammation, it is most commonly a “wear-and-tear” disease involving degen- eration of joint cartilage and formation of bony spurs within various joints. Trauma to the joints, repetitive occupational usage, and obesity are risk factors. Most people older than 60 have this affliction to some extent, but not all require medical care. The main goal of treat- ment is to relieve pain.
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Rheumatoid arthritis is an inflammatory disease that involves episodes of pain and swelling, and in some cases deformity and “freezing” of joints, especially the knuckles and middle joints of the fingers. About 1.3 million Ameri- cans are afflicted. The disease usually starts between the ages of 20 and 45, affecting about three times as many women as men, but it can occur at any age. Juvenile rheumatoid arthritis, a similar condition, affects about 300,000 children and adolescents. The goals of treatment are to reduce pain and inflammation, maintain joint mo- bility, and prevent deformity. Analgesics may relieve the pain, but they do not prevent permanent joint damage. Disease-modifying anti-rheumatic drugs (DMARDs) should be used early in the course of the disease to help prevent later disability. Gout is a metabolic disorder that affects about 2 million Americans, the majority of whom are men. The inflammation of acute gout commonly strikes the big toe, causing pain and swelling, but it can also begin in the knee, ankle, or another joint. In chronic gout a buildup of uric acid crystals in various joints can result in disfigurement and disability. Gout’s course can vary from a few attacks to a progressive disease that begins at puberty and, if untreated, can be disabling by the age of 40. Effective treatment can relieve or prevent attacks and virtually eliminate the risk of permanent disability. Most patients with chronic forms of arthritis can be helped to lead a productive life if their condition is prop- erly diagnosed and treated before too many irreversible changes occur. In many cases treatment can help relieve the discomfort and maintain or restore joint function. Medications for gout control the abnormal metabolism of uric acid. For the other conditions discussed above, the treatment can include medication, rest, exercise, physical therapy, surgery, and various adaptive devices.
In obese individuals weight loss is important to reduce further strain on the joints. Dr. James F. Fries,41 professor of medicine at Stan- ford University, states that successful management of arthritis depends upon the afflicted individual as much as it does on the doctor. He states that people with arthritis must decide how much activity to undertake, whether to see a doctor and when, what kind of doctor to see, when to seek a second opinion, whether to accept medical advice, whether to follow a treatment program carefully, and whether to seek a quack cure or believe a sensational tabloid story. He recommends that a doctor be consulted quickly if joint pain is severe and accompanied by fever or swelling of one or two joints (a possible sign of gout), or if there is inability to use a joint, severe pain from a recent injury, or numbness or tingling related to the joint pain. He also suggests that an appointment should be made for other joint symptoms that have persisted for more than 6 weeks.
Fibromyalgia Fibromyalgia is another painful chronic condition that afflicts an estimated 5 million Americans, most of them women between the ages of 20 and 50. It is loosely de- fined and poorly understood, and there is no objective test for it. The most widely accepted diagnostic criteria are (a) a history of widespread pain (pain on both sides of the body and above and below the waist) that is present for at least three months and (b) undue muscle tenderness at 11 or more of 18 specific areas of the body called “tender points.” However, about half of diagnosed patients do not fit these criteria.42
Fibromyalgia produces no crippling or deformity but can be extremely painful and frustrating to the patient. Fatigue is also a common symptom. The best profession- al to consult is a rheumatologist or a physical medicine specialist (physiatrist) who has a special interest in treat- ing fibromyalgia patients. The recommended treatments include (a) a carefully planned exercise program that in- cludes gentle stretching and gradual progression toward aerobic conditioning, (b) counseling to help understand and cope with the symptoms, and (c) medication (usually a low dose of an antidepressant drug) to improve sleep and help control pain. Physical therapy may be helpful and could include techniques such as heat, ice, massage, whirlpool, and electrical stimulation to help control pain. However, the key to successful management is for the patient to determine through trial and error what types of exercise, activity limitations, and medication sched- ule provide optimal pain relief.43 The Web site www. paintracking.com describes this approach.
√ Consumer Tip
Emergency Medical Identification People with diabetes, major allergies, or any other ill- ness that places them at risk for a sudden, life-threat- ening attack, should carry some form of emergency medical identification. This can be a health card to be carried in the person’s pocket, purse, or wallet or a plastic card or metal tag worn around the neck or wrist. These items should specify the nature of the problem and identify who to contact so that if the person is found unconscious or is unable to communicate, the necessary information is available.
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Diabetes Diabetes is a disease in which the blood sugar (glu- cose) level is too high. The pancreas produces insulin to remove glucose from the blood and store it in cells for future energy needs. In diabetes either the insulin levels are too low or the body has become resistant to the effects of insulin. It is not caused by eating too much sugar. The cause may involve heredity, autoimmune reactions, damage to the pancreas, and excess weight gain. Type I diabetes commonly develops in childhood and requires insulin injections. Type II diabetes affects adults, especially those who are overweight and have a family history of diabetes. It can usually be treated with diet and drugs but sometimes insulin injections are needed. About 18% of Americans older than 60 years have Type II diabetes. Gestational diabetes, a temporary condition that may occur during pregnancy, is discussed in Chapter 19. The classic symptoms, which are more common in Type I than in Type II, are thirst, hunger, weight loss, and frequent urination. It can be diagnosed with blood tests before symptoms develop, and there is a condition of prediabetes in which the blood glucose is not high enough to diagnose the disease but the risk of devel- oping diabetes is increased and preventive measures can be implemented. If untreated, diabetes can lead to ketoacidosis, coma, blindness, cardiovascular disease, nerve damage, kidney failure, and death. It is the leading cause of leg amputations. With proper treatment, the risk of these complications is reduced. Patients on insulin usually require two or more injections a day and four or more blood tests. A dose is calculated to meet basal requirements, with additional amounts to respond to meals. There are various kinds of insulin with different durations of action: regular, intermediate, and slow-acting. These are combined in various ways to respond to each individual’s daily observed peaks or troughs in levels. Sometimes insulin pumps are used to improve control. In Type II diabetes, the first step in treatment is diet, weight loss, and exercise. That alone may normalize blood sugar levels. If not, several oral medications are available that work by different mechanisms. Insulin can be added as a last resort. Hemoglobin A1C levels are used to monitor how well the disease is staying in control over a period of time; these are superior to blood glucose tests that only reflect one point in time. The goal is less than 7% for most patients.44 Tight control of diabetes reduces the risk of complications but increases the risk of hypoglycemia (low blood sugar). Some patients carry a candy bar or a dose of injectable glucagon to reverse hypoglycemia in an emergency.
Diabetes is a chronic disease requiring major life- style modifications. Diabetics have a higher risk of infections. It is important to control interacting risk fac- tors like high blood pressure and cholesterol. Smoking cessation is imperative. Regular foot and eye exams are essential. Newly diagnosed diabetics are taught by diabetes self-management educators45 or with a team approach by doctors, nurses, and registered dietitians. Patients carry a heavy responsibility for their own care. They must:
• Understand the disease. • Understand how diet and exercise affect blood sugar levels. • Follow a diet plan developed by a dietitian specifically for
them. The carbohydrate counting system is best, but there are other methods like the exchange system.
• If taking insulin, learn how to give injections and how to adjust dosage as needed. This includes knowing how to adjust in response to minor illnesses and to compensate for changes in diet, exercise, and time zone.
• Learn how and when to test their own blood glucose with home devices. For Type II diabetics who are not taking insulin and whose diabetes is under control, monthly testing may be enough. Daily testing may be needed for patients who are newly diagnosed or have difficulty stabilizing their blood glucose levels.
• Know warning signs to watch for, including how to recog- nize hypoglycemia and what to do if it occurs.
• Practice daily foot care and inspect skin for infections and ulcerations.
• See their doctor regularly to detect early signs of diabetic complications, to control other risk factors like blood pres- sure, and to monitor how well they are controlling their disease.
Certain herbal products and diet supplements have been claimed to lower blood sugar levels, but any effect is small, and they have not been proven useful enough to be included in the standard treatment of diabetes. The American Diabetes Association is a valuable resource for further information.
Irritable Bowel Syndrome Self-care for an irritable colon requires discovering what triggers attacks and using this knowledge to prevent as well as manage them. (See Consumer Health Insight Box.)
High Blood Pressure Individuals whose high blood pressure is being medi- cally treated can save time and money by checking their pressure at home as part of a medical program. Checks by a physician every 3 months may be sufficient if pres- sure is satisfactory and stable. For home use, Consumer Reports46 recommends using a well-fitting arm cuff
Chapter Fourteen Personal Health and Safety 299
Irritable bowel syndrome (IBS)—also called irritable or spastic colon—is a common functional intestinal disorder character- ized by recurrent abdominal discomfort and abnormal bowel function. The discomfort often begins after eating and goes away after a bowel movement. The symptoms can include cramps, bloating, constipation, diarrhea, and a feeling of incomplete emptying. Self-care plays an essential role in its management. IBS occurs in about one in five Americans, more com- monly in women, and more often at times of emotional stress. It usually begins in late adolescence or early adult life and rarely starts after age 50. In severe cases, it can result in missed work days and curtailment of social activities. Although effective help is available, many people with IBS are too embarrassed, pessimistic, or afraid to seek medical care. Even worse, some people who consult a doctor receive insufficient guidance and conclude that nothing further can be done for them. During normal digestion, foods are broken down in the stomach and small intestine so that their nutrients can be absorbed into the body. Undigested or partially digested por- tions—mostly in liquid form—then enter the large intestine (colon) where most of the water is reabsorbed. Movement through the intestines results from peristalsis, a wavelike contraction of muscles in the intestinal walls that propels their contents forward. When all is well, the end result is stool that is solid but soft enough to be excreted easily. Diet, eating habits, stress, and various environmental factors can disrupt intestinal function. If the intestines squeeze too hard or not enough, the partially digested food can travel too rapidly or too slowly through the digestive system. Move- ment that is too fast will result in diarrhea, because not enough water is reabsorbed. Movement that is too slow can result in constipation, because too much water is absorbed. Overly hard squeezing (spasm) can result in cramps. However, the diarrhea of IBS can also occur without pain. IBS symptoms occur after eating because of the gastro- colic reflex—increased movement of the intestinal contents in response to food entering the stomach. The strength of this reflex can be influenced by the volume and temperature of the food and the number of calories. Large meals (particularly high-fat meals) and large amounts of cold beverages can trig- ger IBS attacks. Medical care should begin with a thorough history and physical examination. The extent of further evaluation de- pends on the patient’s age, general health, and symptoms. If symptoms have been present a long time and have a typical pattern, the doctor may rely mainly on the patient’s descrip- tion to diagnose IBS. If symptoms are recent in origin, testing may be needed to be certain that an infection, inflammatory disease, or tumor is not responsible for the symptoms. The tests may include blood tests, stool tests, x-ray examinations, and endoscopy (examination of the colon with a hollow tubular instrument inserted from below).
The first step in managing IBS should be to identify what triggers the symptoms. The factors to consider include food intolerances, eating habits, dietary factors, emotional stress, exercise habits, use of laxatives, and vitamin C intake. It may help to keep a diary that relates symptoms to daily activities. Many people with IBS have difficulty digesting lactose (milk sugar). This results from a shortage of lactase, an en- zyme normally produced by cells lining the small intestine. When there is not enough lactase, undigested lactose can ferment in the large intestine and cause nausea, cramps, bloat- ing, flatulence, and diarrhea that begin about 30 minutes to 2 hours after consuming lactose-containing foods. If lactose intolerance is significant, lactase drops or tablets can be added to ordinary milk, low-lactose products can be substituted, or dairy products can be avoided (in which case the patient should take calcium supplements). Bloating or excessive gas can also be related to eating habits and diet. Carbonated beverages can introduce gas into the intestines and cause abdominal pain. Eating or drinking rapidly, chewing gum, smoking, nervously gulping air, or wearing loose dentures can cause some people to swallow a large amount of air, some of which reaches the large intestine. Gas can also be produced by such foods as beans, onions, broccoli, and cabbage. Eating more slowly or minimizing gas-forming foods may help. Because caffeine can increase intestinal motility, people with IBS should avoid or minimize the use of coffee, caffein- ated colas, and other caffeine-containing beverages. Fructose or sorbitol (a sugar substitute) can induce diarrhea in some people. Since vitamin C supplements of 1 gram/day or more can cause diarrhea, patients with chronically loose stools should be advised to stop taking them. Unnecessary delay in defecation should be avoided. When an urge is felt, leaving the stool in the colon may contribute to constipation because the longer the contents remain, more fluid may be absorbed. Use of certain laxatives can perpetuate constipation because the large intestine can become dependent on them. People with IBS should not take strong laxatives. Increasing the fiber content of the diet or taking a stool softener such as methylcellulose or psyllium may help regulate bowel movements and reduce both constipation and diarrhea. Increasing dietary fiber should be done gradually to give the body time to adjust. Prescription drugs are available to slow the movement of food through the intestines or to relieve intestinal spasm. In patients with abdominal pain, medication, a hot bath, or a hot water bottle applied to the abdomen may relieve an acute attack. If a certain type of activity is known to trigger an attack, taking an antispasmodic drug beforehand may prevent an attack. If modifiable sources of stress can be discovered, resolving them may help. Regular exercise can also help to normalize bowel action.
Managing Irritable Bowel Syndrome
Consumer Health Insight
Part Four Personal Health Concerns300
device and has rated Omron brand models highest for several years. Chapter 15 discusses the diagnosis and treatment of high blood pressure. Dealing with Poorly Understood Symptoms Modern medicine has made tremendous progress in detecting, treating and managing health problems. Yet many people still suffer from pain and discomfort that is unexplained or poorly understood. In situations like these, consumers must decide whether to seek additional consultations, look for additional treatments, or at least temporarily learn to live with their symptoms. In many cases where the underlying cause is not apparent, it is possible to control the symptoms while hoping the disease process will be come clear as time passes. Because patients often fear that the symptoms represent the onset of a dreaded disease, it can help if the practitioner can provide reassurance that they do not. If symptoms wax and wane, it may be helpful for the patient to keep track of what seems to make them better or worse. Although symptoms are always “real,” it may be important for physicians to acknowledge that they exist and are troublesome. Nettleton and others47 have noted that people whose symptoms have gone undiagnosed for many months or years despite consultations with many doctors may feel marginalized from medical care:
[The patients] observed that they would not be able to benefit from medical advances, nor would they even be eligible to participate in clinical trials. A number had tried a range of complementary treatments but to no effect. The feeling of being passed between health specialists was common and they described being “at sea” not knowing who best to turn to for help. Having no “disease” as such, and no diagnosis, meant that there was ambiguity about whether or not they could legitimately turn to medicine for help. Accessing information was especially difficult; there are not obvious support groups or societies, and as people commented when you do not know what you have got, “what do you type into Google?” self-HelP adviCe
Many books offering health advice to consumers are published each year. Large bookstores typically carry several hundred of them. Dr. Stephen Barrett, who has monitored the selections of many bookstores and mail- order book clubs for more than 30 years, believes that fewer than half of the health-related books have been trustworthy. The Consumer Tip Box lists trustworthy references for a consumer health library. Several provide detailed guidance about self-care and when to see a doctor. The
most practical, Take Care of Yourself,48 focuses on medi- cal problems that consumers can act upon. The book includes information about preventing illness, finding a suitable doctor, avoiding medical fraud, reducing medical costs, and the home pharmacy. It features more than 100 decision charts for managing common health problems. Set up as flow sheets, the charts indicate when to self-treat and when to consult a physician. Chapter 2 identifies additional sources of reliable information. A few books promoting “do-it-yourself” home test- ing have claimed to provide comprehensive advice on self-testing. However, most of the tests they suggested are neither practical nor cost-effective. Several nutrition-related books contain question- naires that supposedly enable readers to determine whether they should take dietary supplements. Such questionnaires, which cover symptoms, lifestyle char- acteristics, and environmental factors, invariably lead to inappropriate recommendations for supplements. Thousands of self-help books and recordings have been marketed to the public with claims that they can help people function better mentally, improve relation- ships with others, relieve anxiety or depression, or achieve other desired emotional changes. Few of these products have been tested for reliability or effectiveness (see Chapter 6). Gambrill49 notes that many books of this type exaggerate people’s ability to alter themselves
√ Consumer Tip
Candidates for a Home Health Library The following books are reliable additions to a con- sumer health library. All are written or closely guided by experts. Most are revised every few years. A good way to buy them is through Amazon Books (www. amazon.com), which discounts most new copies and sells used copies inexpensively. The Merck Manual, which is available free online, is updated periodically. • American Diabetes Association Complete Guide to
Diabetes, 5th Edition (2011) • The American Dietetic Association’s Complete Food
& Nutrition Guide, 3rd Edition (2006) • Consumer Drug Reference (Consumers Union,
2008) • Healthwise Handbook, 17th Edition (2008) • Healthwise for Life, 7th Edition (2007) • Merck Manual Home Health Handbook, 3rd Edition
(2009); online at www.merck.com/pubs • Take Care of Yourself, 9th Edition (2009) • Taking Care of Your Child, 9th Edition (2009)
Chapter Fourteen Personal Health and Safety 301
widespread use, Alcoholics Anonymous (AA) and other 12-step programs have not been proven effective and have been severely criticized for telling people they are powerless and must reply on a “higher power” rather than encouraging active steps to improve their behavior and build self-esteem. Ehrenreich55 has criticized the breast cancer “Pink Ribbon culture” for its social pressure to show unrealistic cheerfulness in response to the disease and for characterizations of breast cancer as a “gift” to embrace with heartfelt gratitude. Self-help groups can be located through the Ameri- can Self-Help Group Clearinghouse (www.mentalhelp. net/selfhelp/) and the National Mental Health Consum- ers’ Self-Help Clearinghouse (www.cdsdirectory.org), both of which can also provide additional information and help for starting new groups. In many parts of the country, local and regional clearinghouses can provide detailed information on groups within the areas they serve. Some groups have chapters listed in the Yellow or Blue Pages of local telephone directories. Note, how- ever, that these sources do not evaluate the quality of the individual groups and that a few self-help organizations promote unscientific concepts.
QuestionaBle self-HelP deviCes Many questionable devices are claimed to promote fit- ness, reduce stress, improve mental functioning, protect against alleged environmental hazards, or provide other “self-care” benefits. Table 14-2 comments on several such products.
internet Considerations
Many electronic groups have formed to share concerns and exchange information about health matters. In June 2011, Yahoo’s Health and Wellness category listed more than 99,000 groups, of which about 8700 were identi- fied as support groups. Electronic groups can provide emotional support, anonymity (helpful for stigmatizing, embarrassing, or sensitive issues), practical tips, and information about medical advances, but they can also attract unsubstantiated testimonials and sales pitches for products. Some groups even screen out skeptical commentary and permit only optimistic appraisals of offbeat treatments. Other problems can include inac- curate information, abusive posting (“flaming”), and privacy issues.56 Quality tends to be higher for groups with moderators who screen out misinformation and advertisements.57 Some support groups maintain online libraries that enable members to post and download information. Quackwatch’s Health Fraud Discussion
or their environment and that failure to achieve the un- realistic goals these books offer can make people more depressed. Public desire for help and easy answers to personal problems has spawned a parade of gurus who offer sim- plistic advice that has never been tested. Salerno50 warns that much of their output “fans the fires of discontent, making people feel impaired or somehow deficient as a prelude to (supposedly) curing them.” self-HelP grouPs
Self-help groups provide opportunities to exchange in- formation, share feelings, provide mutual support, and network with others who have had similar experiences. Their services are rendered through group meetings, telephone conversations, home and hospital visits, edu- cational seminars, practical help (such as transportation and shopping), and residential care. Katz51 has stated:
Self-help, mutual aid groups provide an accepting environ- ment of social support that may not be available from other sources. Their help can have the intimacy and informality of the best family and neighborly assistance. They usually bring together accurate, up-to-date informa- tion on resources and methods for coping with the problem; they often include people at different stages of dealing with it, so that newcomers can learn from the more experienced.
Self-help groups range from local groups with few members to national organizations with tens of thou- sands of members. Some are governed by consensus, whereas others follow parliamentary procedures in establishing committees and electing officers. Some are organized as service delivery systems with authority vested in a national office and an ascending hierarchy of leadership derived from people who have been helped by the group. Some organizations maintain hotlines for immediate aid to people in need. Some have outreach programs in which members make unsolicited offers of help. Some groups have formal orientation programs for group leaders and outreach volunteers. Few published studies provide objective measure- ment of the effectiveness of self-help groups. However, many people who participate in these groups feel they are helpful. Trojan52 queried 232 members from 65 disease-related groups and found that most reported considerable benefit, which they attributed to support by other group members. The reported benefits included reduction of disease-related stress and better ability to relate to others. Kaminer53 has warned that some recov- ery groups are too authoritative, encourage a “victim” mentality, or offer simplistic suggestions for dealing with people. Hall54 has noted that despite its long and
Part Four Personal Health Concerns302
List, which Dr. Stephen Barrett moderates, focuses on many of the topics covered in this text. Many Web sites offer interactive activities for self- evaluation. The most useful ones are available free of charge on sites operated by government agencies and well-known professional organizations. Such tests in- clude risk-factor analysis for cardiovascular disease and body mass index (BMI) calculation for the diagnosis of
obesity. Some sites offer a service whereby the user can post data to follow the progress of a weight-control or other health-promotion program. Consumers should be wary, however, of online questionnaires that recommend buying dietary supplements or herbal products based on the test results. As noted in Chapter 11, these are invari- ably programmed to sell unnecessary products. Web 2.0 provides a platform through which many
Device Type Body Fat Tester
Magnetic EMF Sensor
EMF Absorber
Massaging Hair Brush
Mini Water Dispenser
Mustard Bath
Chlorine Filter for Shower
Magnetic Acu- pressure Eye Massager
Vision WorkOut
QuestionaBle self-Care ProduCts from mail-order Catalogs and tHe internet
Table 14–2
Representative Ad Claims Uses infrared light passing through biceps muscle
to gauge percentage of body fat to track progress toward healthy percent-fat goals.
The Environmental Protection Agency has classified electromagnetic fields (EMFs) as a probable human carcinogen. EMF sensor will quickly alert you to EMF sources . . . guiding your family away from areas of possible health risk at home and at work.
Partially reduces radiation the body absorbs during cell phone use.
Cordless vibrator eases tension, stimulates the flow of nutrients to each hair bulb, and decreases the likeli- hood of hair loss caused by reduced circulation.
Even slight dehydration impairs coordination and thinking and brings on fatigue. Our mini replica of an office water cooler holds exactly 8 glasses of water. Drink from it throughout the day and when done you’ll know you’ve done right!
Product is blended with essential oils to increase circulation, open pores, stimulate sweat glands, relieve congestion, and help rid the body of toxins.
One shower can cause as much absorption of chlo- rine as drinking eight glasses of chlorinated water. Chlorine can cause dry skin, brittle hair, and can be a risk to health.
Increases blood circulation to the eyes and brain; re- duces eyebags; prevents eyestrain, nearsightedness and farsightedness. Mask with pinhole lenses can strengthen weak eye muscles.
Videotapes, depth perception tools, and vision-testing charts enable user to undertake a disciplined eye exercise program that may reduce, postpone, or eliminate the need for corrective lenses.
Remarks The biceps reading may not reflect the
amount elsewhere in the body. Even if it did, few people will benefit from knowing their percentage of body fat.
The Earth’s electromagnetic field can- not be avoided. The small amounts of EMF radiation from high-voltage lines, electric blankets, and other sources have no proven health significance.
There is no proof that such devices sig- nificantly reduce EMF exposure.57
Massaging the scalp will not prevent hair loss.
Under most circumstances thirst is an appropriate guide to the amount of water people need. Drinking a mini- mum of eight glasses of water daily has no proven health benefit.
A warm bath can be relaxing and sooth- ing. Adding aromatic oils conveys no health benefit and does not cause the body to expel “toxins.”
Showering in ordinary tap water poses no health risk. Any dryness of the skin is likely to be related to the frequency of showering and the type of soap or body wash used.
Magnets and massage do not affect circulation or how the eye focuses on images. Pinhole glasses do not influ- ence eye muscle strength.
Exercising the eyes does not deter the changes in the eyes (presbyopia) that reduce the ability to focus as one gets older.
Chapter Fourteen Personal Health and Safety 303
types of information can be exchanged online.59 Health- related sites can integrate personal health information, individually tailored decision support, and social net- working with others who have similar health problems. Using such sites, patients can interact with their physi- cians, receive prescriptions, or have tests ordered without an office visit or telephone call. Lo and Parham60 note that when used optimally, the sites can improve access to health services, enhance the patient’s role in decision- making, improve the quality of care, provide psychoso- cial support, and make the doctor-patient relationship more efficient. But they also caution about risks, such as exposure to misinformation, premature disclosure of bad news, and targeted advertising that may not be helpful.
Privacy Risks The Internet also poses risks connected to personal pri- vacy. The California HealthCare Foundation61 has noted:
To provide . . . customized services, some health sites collect information about their visitors to “serve them better” and, in the process, learn what consumers want and where they buy. The collection of . . . data happens in many ways and with varying degrees of notice as to why and for whom it is being collected. Health Web sites may collect data on users through registration forms, online surveys, and e-mail, as well as, almost invisibly, through the use of cookies and banner advertisements.
In 2000, after surveying 19 major sites, the Foundation concluded:
• Health Web sites may help consumers to better manage their health, but their personal information may not be adequately protected.
• Some sites collect information about individuals without their knowledge or consent.
• Many sites have inadequate privacy policies. • Some sites violate their stated privacy policies. • Some sites give third parties access to the data without
ensuring that privacy standards are met.
Consumer Reports62 adds that “in recent years, pranksters, busybodies, and computer sleuths have dem- onstrated how easy it is to subvert security measures.”
summary
People can do many things to prevent or manage health problems. Health-promotion activities should include tobacco avoidance, a well-balanced diet, reasonable weight, exercising regularly, moderate (if any) alcohol intake, immunizations, brushing and flossing of the teeth, periodic medical and dental examinations, and many types of safety precautions. Most forms of health care involve at least some de- gree of self-care. Consumers need to distinguish between major and minor illnesses and to know when a physician should be consulted. Excellent self-help publications are available for this purpose. People with diabetes and high blood pressure can be treated most effectively and inexpensively with a professionally supervised program that includes in-home testing. The Internet offers many opportunities to gather information and interact with other people. Self-help groups provide opportunities to exchange informa- tion, share feelings, and network with others who have had similar experiences. Online support groups offer anonymity, convenience, and a rapid response, but they may also attract unsubstantiated testimonials, irrational advice, and sales pitches for questionable products. Web users should also guard against bogus interactive tests, dubious products, and privacy risks.
referenCes
1. McCall TB. Examining Your Doctor: A Patient’s Guide to Avoiding Harmful Medical Care. New York, 1995, Birch Lane Press.
2. Vickery DM, Fries JF. Take Care of Yourself: A Consumers’ Guide to Medical Care, ed 4. Reading, Mass., 1990, Addison- Wesley Publishing Co.
3. Poland GA, Jacobson RM. The age-old struggle against the anti- vaccinationists. New England Journal of Medicine 364:97–99, 2011.
4. Meister K and others. Cigarettes: What the Warning Label Doesn’t Tell You, ed 2. New York, 2003, American Council on Science and Health.
5. Behan DF and others. Economic Effects of Environmental Tobacco Smoke. Society of Actuaries, March 31, 2005.
6. Tobacco industry and products. CDC Web site, March 8, 2011. 7. Mokdad AH and others. Actual causes of death in the United
States, 2000. JAMA 291:1238–1244, 2004.
Vaccine Planning You are considering what to do about vaccination when your first child is born. Which of the following would you choose? State your reasons.
__ Trust your future pediatrician __ Base your decision on information you find on the Internet __ Consult a friend or parent __ Follow the recommendations of the Academy of Pediatrics __ Get the recommended vaccinations but over a longer time period __ Other (specify): ______________________
It’s Your Decision
Part Four Personal Health Concerns304
8. Dietary Guidelines for Americans 2010. Washington, D.C., 2011, US Departments of Agriculture and Health and Human Services.
9. O’Brien MC and others. Caffeinated cocktails: Energy drink consumption, high-risk drinking, and alcohol-related conse- quences among college students. Academic Emergency Medi- cine 15:453-460, 2008.
10. Fiore MC and others. Methods used to quit smoking in the United States: Do cessation programs help? JAMA 263:2760–2765, 1990.
11. Dunston A. Kicking Butts in the Twenty-First Century: What Modern Science Has Learned about Smoking Cessation. New York, 2003, American Council on Science and Health.
12. Vaccines: Understanding public perceptions and public confi- dence. Partnership for Prevention Web site, accessed June 6, 2011.
13. Gerber JS, Offit PA. Vaccines and autism: A tale of shifting hypotheses. Clinical Infectious Diseases 48:456–461, 2009.
14. Lantos JD and others. Why we should eliminate personal belief exemptions to vaccine mandates. Journal of Health Politics, Policy and Law 37:101–110, 2011.
15. Offit PA, Moser CA. The problem with Dr Bob’s alternative vaccine schedule. Pediatrics 123e164-e169, 2009.
16. Crislip M, Barrett S. Do children get too many vaccines? The answer is no. Quackwatch Web site, May 29, 2010.
17. FDA warning letter database. FDA Web site, accessed June 6, 2011. 18. Insufficient sleep is a public health epidemic. CDC Web site,
March 17, 2011. 19. Carbon monoxide alarms. See ConsumerReports.org for buying
advice. 20. Child car seats. See ConsumerReports.org for buying advice. 21. Car backup cameras: Aftermarket systems add convenience and
safety. ConsumerReports.org, Feb 2011. 22. Is your home playground a safe place to play? Consumer Product
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effectiveness and health consequences. Environmental Protec- tion Agency Web site, July 26, 2004.
25. New concerns about ionizing air cleaners. Consumer Reports (70):22–25, 2005.
26. Air cleaners: How to choose. ConsumerReports.org, Sept 2010. 27. FTC settlement requires Oreck Corporation to stop making false
and unproven claims that its ultraviolet vacuum and air cleaner can prevent illness. FTC news release, April 7, 2011.
28. Sandman P. Risk communication: Facing public outrage. Peter Sandman Risk Communication Web site, Nov 21, 2001.
29. Facts vs. Fears. New York, 2004, American Council on Science and Health.
30. Scheulpein R, quoted in Segal M. Is it worth the worry? Deter- mining risk. FDA Consumer 24(6):7–11, 1990.
31. Russell C. Placing risk between panic and apathy: A new indus- try emerges. Alicia Patterson Foundation Reporter 11(1), 1988.
32. Food and Drug Administration. A Study of Health Practices and Opinions. Springfield, Va., 1972, National Technical Informa- tion Service.
33. Executive summary. Priorities for capitalizing on life-saving, cost-effective preventive services. Washington, D.C., 2006, Partnership for Prevention.
34. Fischman J. Testing made easy: Direct-from-lab medical results can give patients more power, but they might also harm the unwary. U.S. News & World Report, May 19, 2003.
35. Public health genomics. CDC Web site, Dec 28, 2010. 36. Hall HA, Barrett S. Dubious genetic testing. Quackwatch Web
site, Nov 24, 2008.
37. Genetic horoscopes. Genewatch Web site, Nov 24, 2008. 38. Kutz G. Direct-to-consumer genetic tests: Misleading test re-
sults are further complicated by deceptive marketing and other questionable practices. U.S. Government Accountability Office, July 22, 2010.
39. Johansson SGO and others. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. Journal of Allergy and Clinical Immunology 113:832–836, 2004.
40. Rona RJ and others. The prevalence of food allergy: A meta-analysis. Journal of Allergy and Clinical Immunology 120:636–646, 2007.
41. Fries JF. Arthritis: A Take Care of Yourself Health Guide for Understanding Your Arthritis. Reading, Mass., 1995, Addison- Wesley Publishing Co.
42. Fibromyalgia. Arthritis Foundation Web site, accessed June 6, 2011.
43. Barrett DA. Paintracking: Your Personal Guide to Living Well with Chronic Pain. Amherst, N.Y,. 2012, Prometheus Books.
44. If you have diabetes, know your blood sugar numbers! NIH Publication No. 98-4350, July 2005.
45. Eligibility requirements. National Certification Board for Dia- betes Educators Web site, Nov 23, 2010.
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48. Vickery DM, Fries JF. Take Care of Yourself: A Consumers’ Guide to Medical Care, ed 9. Cambridge, Mass., 2008, Perseus Publishing.
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50. Salerno P. SHAM: How the Self-Help Movement Made America Helpless. New York, 2005, Crown Publishing.
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52. Trojan A. Benefits of self-help groups: A survey of 232 mem- bers of 65 disease-related groups. Social Science and Medicine 29:225–232, 1989.
53. Kaminer W. I’m Dysfunctional, You’re Dysfunctional: The Recovery Movement and Other Self-Help Fashions. Reading, Mass., 1992, Addison-Wesley Publishing Co.
54. Hall HA. AA is faith-based, not evidence-based. Science-Based Medicine, May 19, 2009.
55. Ehrenreich B. Bright-Sided: How the Relentless Promotion of Positive Thinking Has Undermined America. New York, 2009, Metropolitan Books.
56. Eisenbach G. The impact of the Internet on cancer outcomes. CA—A Cancer Journal for Clinicians 53:356–371, 2003.
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58. Listen up! Tips to avoid cell phone radiation scams. FTC con- sumer alert, June 2011.
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CardiovasCular
disease
No matter what advances there are in high-technology medicine, the fundamental message is that any major reduction in deaths and disability from heart disease and stroke will come primarily from prevention, not just cure. This must involve robust reduction of risk factors through encouraging our children to adopt healthy lifestyle habits and by introducing appropriate policies and intervention programmes.
Judith Mackay, M.d.1
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Chapter Fifteen
Part Four Personal Health Concerns306
Keep These poinTs in Mind as You sTudY This ChapTer
Key Concepts
• The more risk factors a person has, the greater the risk of developing cardiovascular disease. Heredity, gender, and age cannot be controlled, but other risk factors can be influenced by the individual’s behavior.
• Risk-factor modification can have a significant impact on both the length and the quality of many people’s life.
• The prevailing medical view is that all adults should have their blood cholesterol and blood pressure checked and take action if abnormalities are found.
• The cornerstone of a cholesterol reduction program is a balanced, low-fat, high-fiber diet plus regular aerobic exercise.
prevalenCe of CardiovasCular disease (2006 esTiMaTes)
Table 15–1
Condition Prevalence* # Deaths High blood pressure 74,500,000 56,600 Coronary heart disease 17,600,000 425,400 Stroke 6,400,000 137,100
*Some individuals have more than one of the above conditions. Source: American Heart Association.2
Few health-related matters have received as much public attention as the relationships among diet, blood cholesterol levels, and heart
disease. Consumers are being urged to know their cho- lesterol numbers, lower the fat content of their diet, exer- cise, and take other steps to reduce the risk of developing heart disease. The data supporting some of this advice are voluminous, complex, incomplete, and sometimes confusing. Yet, based on these data, individuals are be- ing urged to make decisions that may affect the length and quality of their life. The information in this chapter should help you make intelligent decisions based on the latest available research findings. Cardiovascular disease is also an area of explosive technologic development in both diagnostic and treat- ment procedures. As a result, increasing numbers of people will face complex decisions that can affect both their survival and their pocketbook. This chapter covers the causes, risk factors, and man- agement of the two most prevalent problems that affect the heart and blood vessels, with emphasis on strategies for prevention and treatment. The main topic is coronary heart disease, but high blood pressure, which can play a role in both heart attacks and strokes, is included because it involves some of the same considerations. Less com- mon types of heart problems, such as rheumatic heart disease, congenital heart disease, and infections of the heart, are not discussed in this book.
signifiCanCe of CardiovasCular disease
Cardiovascular diseases (problems affecting the heart and blood vessels) are the leading cause of illness and death for both men and women in the United States. The American Heart Association estimates that the total direct and indirect cost of treating heart attacks, strokes (due to blockage of blood supply to the brain),
and other forms of cardiovascular disease in 2010 was $503.2 billion.1 About 34% of the deaths in this country are attributable to cardiovascular disease. The majority stem from atherosclerosis. Before menopause, women tend to have lower blood pressure and fewer heart attacks than do men of equiva- lent age. After menopause, the rates among women are higher than those of men and increase with advancing age. The American Heart Association2 estimates that in 2006, 81.1 million American adults had one or more forms of cardiovascular disease. Table 15-1 indicates the prevalence and mortality of the most common types.
risK faCTors for CoronarY hearT disease
The heart muscle (myocardium) receives its blood from the coronary arteries. In coronary heart disease (CHD), these arteries are narrowed by atherosclerosis, a condition in which fibrous tissue infiltrates from the muscular inner layer of the artery due to repeated injury to the delicate lining of the coronary arteries. These fibrous tissue formations, called plaques or atheromas (-oma = “tumor”), also incorporate fats, cholesterol, and
307Chapter Fifteen Cardiovascular Disease
eventually calcium. These plaques build up on the walls of large and medium-sized arteries. As atherosclerosis progresses, the coronary arteries can narrow and make it difficult for oxygen-rich blood and nutrients to reach the heart muscle. Although atheromas can be reduced by various means, their fibrous structure makes them resistant to anything short of mechanical or surgical intervention—or possibly an intensive cholesterol- lowering program. Reduced blood supply to the heart can result in chest pain (angina pectoris) or other symptoms, typically trig- gered by physical exertion. If a narrowed blood vessel is completely blocked by a blood clot, the area of the heart just beyond the blockage is denied oxygen and nourish- ment, resulting in a heart attack (myocardial infarction). The situation is often complicated by the development of an irregular heart rhythm (arrhythmia) and/or heart failure, in which the heart’s ability to pump blood is inadequate to meet the body’s needs. Like other degenerative disease processes, athero- sclerosis can take years to develop. Inflammation appears to b instrumental in its development.3 Diet is implicated because the deposits on arterial walls contain high lev- els of fat and cholesterol. Studies of both humans and animals have shown links between dietary habits and atherosclerosis. At least nine risk factors can help predict the like- lihood of CHD: heredity, being male, advancing age, cigarette smoking, high blood pressure, diabetes, obe- sity (especially excess abdominal fat), lack of physical activity, and abnormal blood cholesterol levels. The more risk factors a person has, the greater the likelihood of developing heart disease. Heredity, gender, and age cannot be modified, but the others can be influenced by the individual’s behavior. Several of these risk factors are interrelated. Obesity, lack of exercise, and cigarette smoking can raise blood pressure and adversely influence blood cholesterol levels. A 1999 meta-analysis4 concluded that exposure to secondhand smoke increases the risk of fatal and non-fatal CHD in nonsmokers by about 30%. Some authorities believe that emotional stress is a risk factor, but the evidence for this is not clear-cut. A 10-year study of 85,000 women found that coffee consumption had no effect on the incidence of CHD in women.5 The relationship of blood triglyceride levels to cardiovascular disease is unclear, but studies suggest that triglyceride levels of 200 mg/dL or more may be an independent risk factor for CHD.6 Regardless, very high levels (over 500 mg/dL) should be treated because this can cause other problems, such as pancreatitis.
Statin drugs may work by decreasing inflammation as well as by lowering cholesterol. C-reactive protein (CRP) is a marker for inflammation that is associated with cardiovascular risk, especially when a sensitive version of the test—highly sensitive C-reactive protein (hs-CRP)—is used. In the JUPITER trial, healthy people with normal cholesterol levels but high CRP levels who were given a statin drug had significantly fewer heart attacks and deaths. Some doctors are measuring CRP in patients with other risk factors to help them decide which patients need more aggressive treatment, but it has not proven useful as a screening test for the general population. Studies done in the 1980s and 1990s linked elevated blood levels of homocysteine to increased risk of prema- ture coronary artery disease, stroke, and venous blood clots, even among people with normal cholesterol levels. These studies led to speculations that high homocysteine levels are a risk factor that contributes to atherosclero- sis. Supplementation with folic acid, vitamin B6 and/or vitamin B12 can lower abnormal levels, but controlled clinical trials have found no benefit from doing so.7 Other biomarkers include apolipoprotein A1 (in HDL), lipoprotein(a), fibrinogen, PAI-1, asymmetric dimethylarginine, brain natriuretic peptide and NT- proBNP). Research is ongoing, but so far these are not recommended for screening tests or treatment. Many studies have demonstrated that risk-factor reduction is beneficial. The most important study be- gan in 1948 in Framingham, Massachusetts, and is still generating valuable information. A recent analysis based on 50 years of data from this study found that high levels of physical activity, never smoking (men), and normal weight were each associated with a 20% to 40% lower risk of developing cardiovascular disease and an increase in life expectancy of 3 to 4 more years than occurs with low physical activity, current smoking and obesity, respectively.8 Adding stress management to the intervention mix does not appear to improve outcomes.9 The age-adjusted death rates due to coronary artery disease and stroke have fallen steadily for more than 25 years. This is due to advances in diagnosis and treatment as well as lifestyle changes that lower the risk for the disease.10 Table 15-2 can help you evaluate your risk of devel- oping coronary heart disease and what to do about it.
Blood lipid levels
Lipid is the general term for fatty substances, includ- ing triglycerides (fats and oils), phospholipids (such as
Part Four Personal Health Concerns308
WhaT Can Be done aBouT Major Chd risK faCTors
Table 15–2
Risk Factor
Heredity
Gender
Age
Tobacco
High blood pressure
Diabetes
Obesity
Lack of exercise
Abnormal cholesterol levels
Criteria
Family members with CHD, especially at a young age Familial hyperlipidemia
Male gender (Note: women's risk increases after menopause)
Progressively greater risk as age increases
Cigarette smoking and other forms of tobacco Exposure to secondary smoke
Pre-hypertension: 120–139 systolic or 85–89 diastolic Hypertension: over 140/90
Diagnosis by doctor using standard tests
BMI over 25, especially accumulation of abdominal fat
Less than recommended amount of at least 30 minutes of moderate aerobic exercise 5 days a week
HDL under 40 Total cholesterol over 200 LDL cholesterol: Under 100: optimal 130-159: borderline high risk Over 160: high risk
Actions to Take
Not modifiable, but a reason for more aggres- sive control of modifiable risk factors
Not modifiable
Not modifiable
Stop smoking, and avoid exposure to others who smoke.
Dietary modification, weight control, exer- cise, smoking cessation; medication when needed
Dietary modification, weight control, and exercise; medication, insulin as needed to control blood sugar
Weight loss
Exercise more; even small increases are helpful
Diet, exercise, weight control Medication when needed
lecithin), and sterols (including cholesterol). In common usage, fats are lipids that are solid at room temperature, whereas oils are lipids that are liquid at room tempera- ture. (See Chapter 10 for a discussion of the types of fat found in foods.) Blood lipids is a term used to describe the fatty substances circulating within the bloodstream. Cholesterol is found only in foods of animal origin and is part of every animal cell. It is essential to life, be- cause the body uses cholesterol to make cell membranes, hormones, and bile acids, as well as for other functions. Most of the cholesterol the body uses is manufactured within the body, mainly within the liver. When dietary cholesterol intake is high, the liver tends to compensate by lowering cholesterol production. Because cholesterol is a fatlike substance and can- not mix with water, the body transports it in protein- containing packages that can flow smoothly throughout the bloodstream. These packages, called lipoproteins, are composed of various amounts of cholesterol, triglycerides (fats), phospholipids, and other special proteins.
Serum lipoproteins are classified according to den- sity. The three main cholesterol-protein combinations are high-density lipoproteins (HDL), low-density lipopro- teins (LDL), and very-low–density lipoproteins (VLDL). Medical management, however, is based mainly on the levels of total cholesterol, HDL, and LDL. People with high blood levels of HDL have a low risk of developing coronary heart disease.11 Although the reason for this is not certain, many scientists believe that HDL serves as a “scavenger” that transports choles- terol from various cells to the liver, from which it can be excreted in the bile. This helps protect blood vessels against atherosclerosis. HDL may also have some ability to remove cholesterol that has already been deposited in atherosclerotic plaque. Low-density lipoproteins contain about 60% to 70% of the cholesterol carried in the bloodstream. Therefore, when a blood test indicates that total cholesterol is high, this usually means that LDL is undesirably high, but some people (most notably endurance athletes) with high total cholesterol levels have high HDL rather than high
309Chapter Fifteen Cardiovascular Disease
LDL. Because the cholesterol from LDL tends to accu- mulate in the arteries as a component of atherosclerotic plaque, LDL is often called “bad cholesterol,” whereas HDL is called “good cholesterol.” Since the cholesterol both contain is identical, it would be more accurate to refer to them as good or bad lipoproteins. Long-range studies of large population groups have shown that the higher the total cholesterol and LDL lev- els, the greater the risk of a heart attack (Figure 15-1). In 1987, for example, the Framingham Study researchers reported that among people younger than 50, overall deaths rose 5% and heart-related deaths rose 9% for
each 10 mg/dL of total cholesterol.13 Other studies have shown that lowering the cholesterol level through dietary and/or drug treatment decreases the incidence of heart attacks.14,15 For middle-aged men it appears that each 1% reduction in LDL results in a 2% reduction in risk of a heart attack or death from CHD.16 A type of LDL called lipoprotein(a), or Lp(a), has been identified as a possible independent risk factor for CHD, but the data are conflicting.17 Lp(a) has a strong genetic component and is not influenced by diet or most cholesterol-lowering drugs. Although it may turn out to be an important factor in the development of heart disease for some people, no studies have defined what practical steps can be taken to lower abnormally high levels. One study, however, found that lowering elevated LDL appears to reduce the risk of high Lp(a).18 Another study found no association between Lp(a) concentration and the risk of stroke.19
CholesTerol guidelines
Cholesterol and other blood lipids are measured in milligrams per deciliter (mg/dL—a deciliter is 100 ml, about 1/10 of a quart). Total cholesterol, HDL, and tri- glyceride levels are determined by laboratory tests that measure them directly. LDL can be measured directly or calculated by subtracting HDL plus one-fifth of the triglyceride level from total cholesterol. The test to determine total cholesterol, HDL, LDL, and triglyceride levels is called a lipoprotein analysis, or lipid profile (Figure 15-2). Because triglyceride levels are immediately influenced by eating, the blood specimen
figure 15-1. Relationship between serum total cholesterol level and CHD death rate. Based on data from 361,662 men screened for the MRFIT study.12
Serum Cholesterol (mg/dL)
10 -y
ea r C
HD D
ea th
R at
e pe
r 1 00
0
test in range out of range
units reference range
LIPID PROFILE TRIGLYCERIDES 165 MG/DL 20–190 CHOLESTEROL, TOTAL 210 MG/DL LESS THAN 200
HDL-CHOLESTEROL 50 MG/DL GREATER THAN 39
LDL-CHOLESTEROL 127 MG/DL LESS THAN 130 CHOL/HDL-CHOL RATIO 4.20 (CALC) < OR = 4.97
result
name
COLLEGE, JOEL 21 2/9/05 987-65-4321
age date id #
figure 15-2. Sample laboratory report of a male college student whose total cholesterol value is in the borderline high-risk range. The HDL level is ample. The cholesterol/HDL ratio, a measure of risk, is below average for a male. The student should be counseled about risk factors, lower the fat content of his diet, and be rechecked in a year or two.
Part Four Personal Health Concerns310
figure 15-3. Simplified version of the NCEP’s recommendations for adults with no evidence of heart disease. The positive risk factors are age (male ≥45 years, female ≥55 years or premature menopause without estrogen therapy); family history of premature coronary heart disease; smoking; high blood pressure; HDL <40 mg/dL; and diabetes. If HDL ≥60, subtract 1 risk factor from the total of the others. For people with two or more risk factors, 10-year risk is estimated to determine whether intensive treatment is indicated. The Web page http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof enables consumers to calculate their risk.
must be collected after a fast of 9 to 12 hours, usually done overnight. In 1987 the National Heart, Lung, and Blood Insti- tute’s National Cholesterol Education Program (NCEP) recommended that all Americans ages 20 and older have their total blood cholesterol level measured as part of a routine medical evaluation that also considers other risk factors for heart disease. In 1993 the guidelines were revised to add screening for low HDL levels. In 2001, the guidelines were revised again to emphasize primary prevention in persons with multiple risk factors and more aggressive treatment of people with known CHD. Table 15-3 summarizes NCEP’s cholesterol-level classification system. About 50% of Americans have a total cholesterol level of 200 or above. NCEP’s current guidelines20 call for measuring total cholesterol and HDL at least once every 5 years begin- ning at age 20. The most efficient way to do this is to use a lipid profile as a screening test. If total cholesterol is 240 or more or HDL is less than 40, the test should be repeated. If the first and second LDL levels are similar, the results are averaged. If they are more than 30 mg/dL apart, a third test is done and averaged with the others. Figure 15-3 summarizes NCEP’s recommended actions for adults who do not have heart disease. For those who do, the recommended treatment is based on the individual’s average level of LDL and number of
risk factors.21 Regardless, dietary measures and exercise should be the cornerstone of any treatment program.
Problems with Lipid Screening Tests Management of cholesterol levels is complicated by the fact that laboratory tests have considerable potential for error. Test results can vary from sample to sample, and some facilities do not perform the test accurately. Levels vary at different times within the individual. How the test is done also influences the results. Food intake, changes of position (lying down, sitting, or stand- ing), weight change, alcohol intake, various illnesses, and the technique used to collect the specimen can cause variations. “Finger-stick” tests sometimes used in mass screenings are not as accurate as tests using blood drawn from the arm. An erroneously high reading can cause needless wor- ry and expense. An erroneously low reading can lead an individual to fail to take appropriate action. Considering
nCep ClassifiCaTion of seruM CholesTerol levels (Mg/dl)*
LDL-cholesterol Under 100 Optimal 100–129 Near optimal/above optimal 130–159 Borderline high-risk 160–189 High 190 or more Very high
Total cholesterol Under 200 Desirable 200–239 Borderline high 240 or more High
HDL-cholesterol Under 40 Low 60 or more High
Table 15–3
*Many scientific publications follow the Systeme International, which expresses cholesterol values in millimoles per liter (mmol/L). To convert mg/dL to mmol/L, multiply by 0.02586 and round off to the nearest 0.05. Thus 200 mg/dL would be 5.15 mmol/L, and 130 mg/dL would be 3.35 mmol/L.
Get lipid analysis after a 9- to 12-hour overnight fast.
Maintain good health habits. Get tested again within five years.
Is your LDL 160 or more?
YES NO
Change your lifestyle: eat less fat, exercise aerobically, control your weight, don’t smoke.
Do you have two or more risk factors?
YES
Make lifestyle changes. If that does not improve your blood cho- lesterol levels sufficiently, drug therapy may be advisable.
NO
Is your LDL 130 or more?
YES NO
Is your HDL under 40?
YES NO
311Chapter Fifteen Cardiovascular Disease
the test’s relatively low cost and the problems that can result from an inaccurate report, it is wise to obtain the test from a laboratory recommended by one’s personal physician. Although the FDA has approved a home cholesterol test kit, this test is rarely practical because it measures only the total cholesterol level. Current guidelines for screening include HDL testing and a lipid profile for anyone whose total cholesterol is high. Unnecessary expense can be avoided by starting with a lipid profile ordered through a physician’s office.
dieTarY ModifiCaTion
Most of the cholesterol the body needs is produced in the liver. The rest is derived from animal products (meat, fish, milk, eggs) in the diet. Among the dietary factors, the amount and type of fat eaten have the greatest impact on the blood cholesterol level. Decreased consumption of saturated fats usually results in lower blood cholesterol, as does substitution of polyunsaturated or monounsatu- rated fats for some saturated fats in the diet. Trans-fatty acids, commonly found in margarine, pastries, and fat-containing snack foods, tend to reduce HDL and increase LDL.22 The labels of products con- taining trans-fatty acids list “partially hydrogenated oil” as an ingredient. The FDA requires that the amount of trans-fatty acids be listed on product labels.23 Dietary cholesterol affects the level of blood choles- terol, but to a lesser and more variable extent than does the fat content of the diet. A high intake of soluble fiber (found in oat products, beans, and some other complex carbohydrate foods) can help to lower blood cholesterol levels. Studies have shown that people who consume more vegetables, fruits, and cereal fibers have a lower incidence of coronary heart disease.24,25 Table 15-4 describes the Therapeutic Lifestyle Changes (TLC) diet recommended for cholesterol re- duction. Dietary change must be permanent. Currently, about 37% of Americans’ total caloric intake is from fat. The TLC diet would reduce this to 25% to 35%. Dietary cholesterol intake, which typically is 350 to 450 mg/day, would be reduced to less than 200 mg/day. Diets limited to 10% fat are more effective in lowering total blood cholesterol and LDL values,26 but few people are willing to change their diet that drasti- cally. Mirkin and Rich27 have noted that for most adults, a 10% fat level will be achieved by limiting daily fat intake to 20 g. Questions have been raised about whether lowering
cholesterol increases the risk of certain cancers.28 The predominant medical view is that it does not.29 To assist consumers trying to improve their blood cholesterol levels and reduce their risk of cardiovascular disease, the American Heart Association30 recommends these general guidelines:
• Balance calorie intake and physical activity to achieve or maintain a healthy body weight.
• Consume a diet rich in vegetables and fruits. • Choose whole-grain, high-fiber foods. • Consume fish, especially oily fish, at least twice a week. • Limit your intake of saturated fat to 7% of energy, trans fat to 1% of energy, and cholesterol to 300 mg per day by: • Choosing lean meats and vegetable alternatives • Selecting fat-free (skim), 1%-fat, and low-fat dairy products • Minimizing intake of partially hydrogenated fats
• Minimize your intake of beverages and foods with added sugars.
• Choose and prepare foods with little or no salt. • If you consume alcohol, do so in moderation. • When you eat food that is prepared outside of the home, follow the above recommendations.
The first practical step toward dietary change is to become more aware of one’s diet, especially the amount of food eaten and the brands usually purchased. Toward this end, consumers should get into the habit of check- ing labels to determine the amount of cholesterol and the amount and type of fat. They should also be aware of the “hidden” fats found in processed foods such as cookies, crackers, and snack cakes, and the kinds of fats and oils used in their own cooking.
nuTrienT CoMposiTion of The TherapeuTiC lifesTYle Changes (TlC) dieT
Table 15–4
Nutrient Category Saturated fat Polyunsaturated fat Monounsaturated fat Total fat Carbohydrates Fiber Protein Cholesterol Total calories
Recommended Intake Less than 7% of calories Up to 10% of calories Up to 20% of calories 25% to 35% of calories 50% to 60% of calories 20–30 g/day Approximately 15% of calories Less than 200 mg/day Balance energy intake and expen- diture to maintain desirable body weight/prevent weight gain
Part Four Personal Health Concerns312
The next step is to make substitutions for red meats. For example, leaner beef cuts (select or choice) can be substituted for fatter cuts (prime), and consumption of fish, poultry, fresh fruits and vegetables, beans, and other legumes can be increased. Foods high in com- plex carbohydrates—such as whole grains, beans, and vegetables—can be made the “main dish,” with small amounts of red meats and cheeses becoming the “side dishes.” Mixed dishes such as stews, casseroles, and pasta and rice meals can combine small amounts of meat with other foods, such as grains or vegetables. Finally, consumers should evaluate their progress by having their blood cholesterol tested within a few months and then periodically as recommended by the professional who is guiding them. The goal should be a gradual but steady reduction in the total cholesterol and LDL-cholesterol levels. Because the major sources of saturated fat in the American diet traditionally have come from beef and dairy products, dietary advice aimed at lowering blood cholesterol often focuses on cutting back on hamburgers and fatty meats, whole milk, and cheeses—and getting into a habit of preparing foods with less fat. The “Dietary Modification” box suggests how to reduce the fat and cholesterol content of one’s diet. Food companies have responded to public concern by marketing thousands of products that are fat- and cho- lesterol-reduced. However, shoppers should not assume that products labeled as “reduced fat” or “% fat-free” are low in fat. If a package says “95% fat-free,” that merely means that 95% of the product’s weight doesn’t contain fat. The rest can be anything, including water. Many products with “% fat-free” claims contain more than 25% to 50% of their calories as fat, and many “reduced fat” products have more than 50% of their calories as fat. For this reason, shoppers seeking to determine fat content should inspect the “Nutrition Facts” box and divide the fat calories per serving by the total calories per serving. Some observers—most notably Gary Taubes31— postulate that low fat diets have been counterproduc- tive, leading Americans to replace fats with more carbohydrates, gain weight, and increase their risk of cardiovascular disease. They cite evidence suggesting that carbohydrates, not fats, might be the sole cause of obesity and also cause heart disease, diabetes, cancer, and many other diseases. But Hall32 notes that Taubes discredits what he calls the “low fat myth,” only to re- place it with his own “low carb myth,” and he admits that these competing ideas have not yet been properly tested. Pending proper testing, the most reasonable course is to accept the current consensus of experts.
Dietary Analysis Following the guidelines in the “Dietary Modification” box will reduce the fat, saturated fat, and cholesterol content of the diet and should come close to the fat and saturated-fat levels recommended in the NCEP’s TLC diet. However, the only way to determine how much fat and cholesterol are actually consumed is to calculate the amounts contained in one’s daily diet. The MyPyramidTracker Web site (www.mypyramidtracker. gov) offers a practical way to do this. After setting up a password-protected account, the user can construct a favorite-food list and enter data each day to determine the overall fat percentage as well as how one’s diet compares to the Dietary Guidelines for Americans. Computer programs are also available for determin- ing fat and cholesterol intake. Those containing large databases, including nutritional analyses of brand-name products and fast food items, generally provide the most accurate information. Computer programs are accessible to consumers at certain clinics and through nutrition professionals in private practice. Some are also marketed directly to the public for home use. The USDA maintains a food composition database33 at www.nal.usda.gov/fnic/ foodcomp. Despite these aids, some consumers wishing to design a diet that is significantly low in fat would be wise to consult a registered dietitian or other profes- sional nutritionist. Chapter 10 describes the training and credentials of nutrition professionals. Soluble Fiber Controlled studies have demonstrated that a diet high in soluble fiber can improve blood cholesterol levels.34 Well-controlled intervention studies have shown that four major water-soluble fiber types—beta-glucan, psyl- lium, pectin, and guar gum—effectively lower serum LDL without affecting HDL. It is estimated that for each additional gram of water-soluble fiber in the diet, serum total and LDL cholesterol concentrations decrease by about 1 mg/dL. It appears likely that soluble fiber interferes with the (re)absorption of bile acids from the intestine into the liver, causing the liver to pull more LDL from the bloodstream. Epidemiologic studies suggest that a diet high in water-soluble fiber lowers the risk of cardiovascular disease. The foods highest in soluble fiber include oat bran, dry oats, kidney beans, navy beans, pinto beans, lima beans, white beans, Brussels sprouts, kale, broccoli, plums, apples, oranges, and grapefruit (including the fibrous partitions). Large amounts of fiber increase the bulk of the stool and can cause bloating, cramps, and diarrhea. However, discomfort can be minimized or
313Chapter Fifteen Cardiovascular Disease
The following can help you choose and prepare foods lower in saturated fat and cholesterol:
• Trim all visible fat from beef and poultry, and remove the skin from poultry before eating.
• Bake, broil, or roast meat dishes instead of deep- fat–frying them. To prevent drying and to add flavor, baste with wine, lemon juice, or a low-fat broth.
• Try experimenting with herbs and spices, such as dill, tarragon, cilantro, and basil.
• Avoid fatty gravies and sauces.
• If pan- or stir-frying, use a small amount of vegetable oil such as canola or safflower oil; also increase your use of olive oil.
• Minimize use of butter.
• Minimize use of products, such as margarines, that contain partially hydrogenated oils (trans-fatty acids).
• To cut down on whole-milk products, switch to 2% or 1% milk, and perhaps eventually to skim milk. Many people find it easy to get accustomed to low-fat milk, and that when they do so, whole milk tastes too rich. Use the low-fat or skim-milk versions of ricotta, cottage, and mozzarella cheese. Fat-free and low-fat farmer and pot cheeses also are available. All these cheeses should contain no more than 2–6 g of fat per ounce. For desserts, substitute ice milk, frozen yogurt (especially the nonfat variety), sherbet, or sorbet for ice cream. If you do eat ice cream, choose regular rather than super premium types.
• Limit consumption of foods that contain palm, palm kernel, and coconut oils; lard; butter; unidentified shortening; egg-yolk solids; and whole-milk solids. Also, cut down on baked goods made from these ingredients or that are fried, such as doughnuts.
• Use nonfat or low-fat yogurt instead of sour cream in dips and toppings.
• Use only the egg whites or discard every other yolk in recipes requiring eggs (2 whites = 1 whole egg in recipes). Or try a commercial cholesterol-free egg substitute.
• Reduce the amount of fat in recipes by one-third to one-half, and use chiefly polyunsaturated and mono- unsaturated oils.
• Shrimp, lobster, and other shellfish may be eaten occasionally because they are lower in cholesterol than previously thought, and do not contain too much saturated fat.
dietary modification for cholesterol control
• In coffee, instead of using a nondairy creamer that contains saturated fats, use low-fat or skim milk, skim milk powder, or a fat-free nondairy creamer.
• Substitute rice and pasta for egg noodles.
• Make your own popcorn for a low-calorie snack, but be sure to omit the melted butter. Beware of high-fat microwave popcorn products.
• Avoid nuts that are high in saturated fats, such as coconuts and macadamia nuts.
• Incorporate oat fiber into your diet, for example, in oat bran muffins or in casseroles. To increase total fiber intake, look for the words “whole wheat” or “whole grain” near the top of the ingredient list when buying breads and cereals.
• Use fresh fruit instead of high-fat desserts.
• Choose low-fat luncheon meats such as chicken or turkey breast instead of salami and bologna. Use frankfurters, other sausages, and bacon sparingly. When eating poultry, remember that white meat has less fat than dark meat.
• Buy or make salad dressings with predominantly un- saturated oils. Olive oil is an especially good choice. Or try a nonfat type or just vinegar or lemon juice.
• Limit use of organ meats that are very high in choles- terol, such as liver, kidneys, brain, and sweetbreads.
• Prepare soups and stews containing meat the day before eating them. After refrigerating, skim off the congealed fat on the surface before reheating.
• Be cautious about store-bought baked products such as pies, cakes, croissants, pastries, and muffins. Try to find low-fat cookies and crackers. Or bake at home with small amounts of unsaturated oil or with pureed fruit such as applesauce or prune butter substituted for some of the oil. Angel food cake is a good choice because it is low in fat and cholesterol.
• Use some of the many fat-free, cholesterol-free prod- ucts marketed as substitutes for products that nor- mally are high in fat. But don’t eat so much of them that you lose control of your weight.
• Make changes gradually to avoid feeling deprived. For most people, enjoying a rich dessert or a prime rib once in a while is not going to significantly affect their cholesterol level as long as the overall choles- terol-lowering diet is followed most of the time. It is better to splurge once in a while than to cheat a little bit each day.
Source: Quackwatch Web site.35
Part Four Personal Health Concerns314
prevented if the amount of dietary fiber is increased gradually, so the body can become accustomed to it.
Helpful Fatty Acids Randomized, controlled studies have demonstrated that consuming omega-3 fatty acids in fish or supplements can decrease the progression of atherosclerosis and re- duce the risk of heart attacks and strokes among people with proven coronary artery disease. The best known fatty acids are eicosapentaenoic acid (EPA) and doco- sahexaenoic acid (DHA). Additional studies are needed to evaluate whether apparently healthy people will also benefit. Meanwhile, the American Heart Association36 recommends:
• Patients without documented coronary heart disease should eat a variety of (preferably oily) fish at least twice a week and include oils and foods rich in alpha-linolenic acid (flaxseed, canola, and soybean oils; flaxseed and walnuts)
• Patients with documented coronary heart disease should consume approximately 1 g of EPA+DHA per day, pref- erably from oily fish. EPA+DHA supplements could be considered in consultation with a physician.
• Patients needing triglyceride-lowering should take 2 to 4 g of EPA+DHA per day provided as capsules under a physi- cian’s care.
A prescription drug fish-oil capsule (Lovaza) that contains 47% EPA, 38% DHA, and 17% other omega-3s has been FDA-approved as an adjunct to diet for lowering very high triglyceride levels in adults. It is best to minimize or avoid fish that may be contaminated with mercury. The fish highest in omega-3 fatty acids and low in mercury include Atlantic salmon, Atlantic herring, canned pink salmon, whitefish, Atlantic mackerel, rainbow trout, bluefish, and oil-canned sardines. In 2003, Consumer Reports37 reported that its tests of 16 brands of fish-oil supplements found that all contained the amounts of fatty acids stated on their labels and were not contaminated, but prices varied considerably.
Regression of Atherosclerosis Many studies have shown that improving blood- cholesterol levels can reduce the incidence of and mortality from heart disease and that the greater the LDL reduction, the better the results.38 Some drug trials have used angiography or ultra- sound procedures to determine whether coronary athero- sclerosis has increased (progressed), remained the same, or decreased (regressed) during a treatment period. This is done by measuring areas of narrowing and blood flow within the coronary arteries.
√ Consumer Tip
A Quick Fat-Chemistry Lesson You need not know the chemical structure of fats to understand a low-fat diet. But for those who want a technical explanation, here it is. Fats are classified by the amount of hydrogen in the fatty acids that make up their basic structure. Fatty acids are composed of chains of carbon atoms tied together: –C–C–C–C–C–C–C–C–C–C–C–C–. . .
Each carbon atom has four arms that can attach to other elements:
–C–
All the arms must be attached to something else. Fatty acids have hydrogen atoms attached to the carbons: H H H –C–C–C–. . . H H H
All carbons have four binding arms. All hydrogens have one. Some carbons do not have hydrogen attached to them. They have to bind to something else, so they bind twice to the next carbon. This is called a double bond: H H –C–C=C–C–. . . H H H H
Fatty acids are classified by the number and location of their double bonds. Those with no double bonds are called saturated: H H H H H H H –C–C–C–C–C–C–C–. . . H H H H H H H
Fatty acids that contain several double bonds are called polyunsaturated:
H H H –C–C–C=C–C=C–C–. . . H H H H H H H
Fatty acids with only a single double bond are called monounsaturated: H H H H H –C–C–C=C–C–C–C–. . . H H H H H H H
All fatty acids have a carbon end and an acidic end. Polyunsaturated fats are further classified by where their double bonds are located. Those with the double bond three atoms away from the carbon at the nonacidic end of the chain of carbons are called omega–3s: H H H H H H–C–C–C=C–C–C–C–. . . H H H H H H H
Gabe Mirkin, M.D.
315Chapter Fifteen Cardiovascular Disease
carbohydrates. It allows 3.5 oz of fish, poultry, or lean meat per day, which makes it almost a vegetarian diet. The diet is part of an overall program that includes exercise and prohibits smoking and alcohol intake.45 During 2011, the first week of the residential program at the Pritikin Longevity Center & Spa in Miami, Florida, cost $3950 or more, depending on the season, type of room, and chosen program. Subsequent weeks cost less. Pritikin claimed that his program helped many people with heart disease, obesity, diabetes, and other health problems. The overall approach is similar to con- ventional therapy for cardiac patients but uses a more restrictive diet. The Pritikin diet can achieve consider- able reduction in blood cholesterol levels. However, its fiber content is quite high (about 30 g per 1000 calories), which may cause abdominal cramps, bloating, and diar- rhea. Dr. Ornish’s trial suggests that for some patients, the Pritikin diet may protect the heart better than a 20%- fat diet. As with the Ornish diet, no direct comparative study has been carried out, however, so it is not clear whether the potential benefits of these diets justify the extensive dietary changes they require.
Misleading Advertising Americans are more familiar with “cholesterol” than it is with “saturated fat.” Because of this, when public discussion of cholesterol and cardiovascular disease increased, many manufacturers made “no-cholesterol” claims, even for foods that are high in fat. Unsuspecting consumers interested in trying to adopt healthier eating habits might actually make things worse by eating these foods. A similar situation exists for some products con- taining oat bran. Although oat bran can play a valuable cholesterol-lowering role as part of a low-fat diet, some “oat bran” products contain insignificant amounts of oat bran or contain undesirable amounts of fat as well. In 1994 the FDA began requiring the labels of nearly all packaged foods to disclose the amounts of total fat, saturated fat, cholesterol, and fiber per serving size; recently, trans-fat was added to this list. (See Chapter 10.) The regulations also ban “no cholesterol” claims for foods that are high in fat. Presumably accurate informa- tion is now displayed in the “Nutrition Facts” boxes on product labels and packages, but misleading slogans still appear on a few products.
lipid-loWering drugs
The NCEP considers dietary treatment the cornerstone of therapy to reduce elevated cholesterol levels. The primary goal of dietary therapy is to maintain an LDL level below 130 mg/dL. It is assumed that this will
The Lifestyle Heart Trial demonstrated that regres- sion can occur through changes of lifestyle alone, includ- ing a 10%-fat semi-vegetarian diet, smoking cessation, stress management techniques, and daily moderate exercise. The only animal products permitted in the treat- ment group’s diet were egg whites and 1 cup a day of nonfat milk or yogurt. Cholesterol intake was 5 mg/day or less. The control group was asked to adhere to a 30% fat diet. After 1 year, 18 of the 22 members (82%) of the treatment group showed overall regression of coronary atherosclerosis, whereas 10 of the 19 members (53%) of the control group showed substantial progression of their disease.39,40 Dean Ornish, M.D., who directed the trial, re- ported that the degree of regression was related more to compliance with the low-fat diet than it was to the change in blood cholesterol level. After 4 more years, the experimental group continued to do better than the control group, some of whom took cholesterol-lowering drugs.41,42 Although Ornish’s findings have not been replicated by others, his data have been sufficiently fa- vorable that Medicare and several insurance companies are covering his program as an alternative to bypass surgery or angioplasty. In addition to the full program, Ornish’s nonprofit Preventive Medicine Research Insti- tute offers a 1-week residential retreat for learning how to make comprehensive lifestyle changes. Caldwell B. Esselstyn, Jr., M.D.,43 a surgeon at the Cleveland Clinic, believes that atherosclerosis can be reversed by lowering the total cholesterol level below 150 mg/dL. To achieve this, he recommends a vegan diet (10% to 15% fat) plus statin medication if necessary. In 1999, he reported that 17 out of 18 patients with severe atherosclerotic heart disease who followed his program for 12 years experienced no further cardiac difficulty. His 2010 book, Prevent and Reverse Heart Disease,44 includes additional follow-up of some of the patients. Hall45 has cautioned that Esselstyn's uncontrolled ob- servations are not a substitute for well-designed clinical trials that test not only cardiovascular outcome but also whether the program increases the risk of other diseases. The Pritikin Diet The Pritikin diet was designed by the late Nathan Pri- tikin, a successful inventor who had no professional training in medicine or nutrition. Pritikin developed the diet after learning at age 40 that his cholesterol level was high and his coronary arteries were atherosclerotic. This diet is very low in fat, high in complex carbohydrates, and low in sodium. Its recommended calorie composi- tion is less than 10% fat, 10% to 15% protein, less than 5% simple carbohydrates, and 75% to 80% complex
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help prevent heart attacks by inhibiting further buildup of atherosclerotic plaque and perhaps by reducing the amount of plaque already present. If the TLC diet and other lifestyle improvements fail to correct elevated LDL levels within about 6 months, drug therapy should be considered in addition to diet. The choice of drug depends on the medical con- dition of the patient, the nature of the patient’s blood lipid abnormalities, concern about adverse effects, and cost. Niacin (nicotinic acid) and the “statins” reduce cholesterol production. Bile acid sequestrants bind with cholesterol-containing bile acids in the intestines and remove them in bowel movements. Fibric acid deriva- tives may be used for patients whose problems include high triglyceride levels. Table 15-5 provides an overview of the commonly used drugs. If one drug is not effec- tive, two may be used together. The Medical Letter46
has concluded that, for most patients, statins are the best choice because they are more effective and better tolerated than the rest and have been proven to decrease mortality from coronary heart disease. Niacin is available in three forms: immediate- release, extended (8-hour) release, and sustained (12–24 hour) release. The usual dosage for cholesterol control is 1 to 3 g daily. Sustained- and extended-release prod- ucts have fewer annoying side effects and may be more potent than regular niacin, but sustained-release prod- ucts have a higher incidence of serious adverse effects. Extended-release niacin is a prescription drug; the others are regulated as dietary supplements and do not require a prescription Self-medication with niacin is extremely unwise. Near-fatal hepatitis has been reported in a previously healthy 32-year-old man who had taken one 500-mg
CoMparison of CoMMonlY used CholesTerol-loWering drugs
Table 15–5
Category/Name
Nicotinic acid (niacin) Crystalline niacin Sustained-release niacin Extended-release niacin (Niaspan)
Bile acid sequestrants Cholestyramine (Questran) Colesevelan (Welchol) Colestipol (Colestid)
HMG coA reductase in- hibitors (“statins”)
Atorvastatin (Lipitor) Fluvastatin (Lescol) Lovastatin (Mevacor) Pravastatin (Pravachol) Rosuvastatin (Crestor) Simvastatin (Zocor)
Fibric acid derivatives Clofibrate Fenofibrate (Tricor) Gemfibrozil (Lopid)*
Cholesterol Absorption Inhibitor
Ezetimibe (Zetia)
LDL
+++ +++ +++
++ ++ ++
++++ ++++ +++ +++ ++++ +++
++ ++ +
++
HDL
+++ +++ +++
+ + +
+ + + + + +
++ ++ ++
+
Cost
+ +
+++
+++* +++* ++++
++++ ++* +++ +++* +++ +++*
+++ +++ ++*
+++
Advantages
Most cost-effective; proven effective for reducing heart attacks; may lower Lp(a).
Work within the intestine and therefore are not absorbed by the body.
Most effective for lowering LDL; proven effective for reducing heart attacks.
Useful against elevated triglyceride levels.
Mainly useful for people who cannot take statins.
Side Effects
Flushing, burning, and itching of the skin; nausea; abnormal liver function; gout. Long-acting products have fewer side effects, but have a higher incidence of serious complications.
Constipation, nausea, bloating, heartburn; can interfere with absorption of fat- soluble vitamins and some drugs.
Diarrhea, flatulence, flu-like symptoms, elevated liver enzymes, muscle aches
GI distress, rash, gallstones.
Diarrhea; flu-like symptoms; fatigue; arm and leg pain
*Generic available at significantly lower cost than brand-name drug. Key: + = lowest, ++++ = highest
317Chapter Fifteen Cardiovascular Disease
sustained-release niacin tablet daily for 2 months, pur- chased at a health-food store.47 Several observers have expressed concern that sustained-released niacin can be purchased without a prescription.48-51 Niacin users should have periodic blood tests of liver function to be sure that the niacin is not irritating their liver. The cost of cholesterol-lowering drugs ranges from about $75 a year for immediate-release niacin to more than $1200 a year for several of the prescription drugs. Once an appropriate regimen has been found, lipid-low- ering therapy should be continued indefinitely because when it is stopped, plasma cholesterol concentrations generally return to their pretreatment levels.
prevenTive use of aspirin
Low doses of aspirin decrease the synthesis of hormone- like substances called prostaglandins, which affect blood clotting by causing platelets to cluster where blood
vessel walls are injured. Aspirin may therefore help by inhibiting the formation of clots that can block the flow of blood in the arteries that nourish the heart and brain. Studies have shown that taking aspirin reduces the risk of heart attacks and strokes among persons who have previously suffered such an event. Whether it does so in apparently healthy people is unclear. A 2008 meta- analysis52 concluded that aspirin therapy reduced the rick of ischemic stroke in women and heart attacks in men, but it significantly increased the risk of bleeding to a similar degree among women and men. The usual recommended daily dosage is from 75 mg (less than a baby aspirin) to 325 mg (an adult-strength tablet). Aspirin’s antiplatelet ability will cause some people who use it regularly to develop abnormal bleed- ing. The American Heart Association recommends that decisions about aspirin use involve consultation with a physician who reviews the patient’s risk factors and medical history and other preventive strategies.
Consumer Health Insight
Cholesterol Denial
Some contrarians deny that blood cholesterol levels have anything to do with heart disease. They have written books like Uffe Ravnskov’s The Cholesterol Myths and even formed an activist organization, The International Network of Cholesterol Skeptics (THINCS). They claim that (a) high cholesterol levels are beneficial, (b) low cholesterol levels are unhealthy, (c) there is no need to restrict choles- terol in the diet, and (d) statin drugs are dangerous. There are a few grains of truth behind their claims: for instance, they correctly say that (a) it would be simplistic to consider cholesterol “the cause” of heart disease and (b) simply avoiding dietary cholesterol makes little or no difference in the death rate. But they take information out of context, ex- aggerate, misinterpret, and misrepresent the data. Instead of looking at the entire body of scientific research, they cherry-pick a few studies that they interpret as supporting their views.53 But when all the evidence is considered, it clearly shows that LDL cholesterol is strongly associated with cardiovascular risk and that lowering LDL reduces the risk of cardiovascular events and overall mortality. In fact, the degree of cholesterol-lowering serves as a reliable marker to measure the degree of reduced risk. As for diet, the original idea that dietary cholesterol should be strictly avoided was quickly replaced by the idea of limiting total fat intake and that has been further modified to target saturated fats and trans-fats, and most heart-healthy diets now allow small amounts of dietary cholesterol. Further changes in recommendations will
surely be forthcoming as the scientific community con- tinues to refine its understanding of CHD. Restricting dietary cholesterol alone has little ef- fect on cholesterol levels; and standard low-fat diets are generally not very effective by themselves, so it is often necessary to add a drug. Statins have been proven to lower the risk of heart attacks and reduce the overall death rate. Cholesterol deniers refuse to accept these facts. They also have a distorted, overly simplistic view of current medical practice, accusing doctors of “pushing pills” automatically. That’s not what usually happens. Instead of fixating on the one risk factor of elevated cholesterol in isolation, competent doctors assess the patient’s overall risk status. For example, patients with the same mildly elevated lipid levels might have different risk factors, so that one with no other risk factors may not need treatment, whereas another may fall in a high-risk category that merits aggressive prevention. Cholesterol deniers also tell alarmist stories that exag- gerate the side effects of statin drugs. They accuse statins of causing devastating side effects like rhabdomyolysis (muscle breakdown) and cancers. In reality, as currently used, they are very safe. The JUPITER study, for example, found no more side effects reported by the statin group than by the placebo group.54 And repeated studies have failed to show any correlation of statins with cancer. In fact, some evidence suggests that statins might actually prevent some cancers.
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QuesTionaBle prevenTive Measures
Many over-the-counter products sold through health- food stores and pharmacies have been touted as useful for preventing cardiovascular disease by lowering blood- cholesterol levels or through another mechanism. Many manufacturers market combinations of such ingredients. Except for crystalline niacin and fish oils, which should never be taken without medical supervision, no product of this type is rationally formulated. Even if future re- search demonstrates that any of the substances discussed
in this section can exert a protective effect, it is unlikely that any such effect will be significant when compared to the lifestyle modifications and drug therapy already known to be effective. Garlic extract capsules may lower cholesterol and may also exert an anticoagulant effect, but they have not been proven safe or effective for long-term use.55 Eating several cloves of garlic daily can also have an impact on cholesterol but will cause the individual to have bad breath and to exude an offensive odor through the skin. Vitamin E has been touted for its antioxidant effect. Epidemiologic studies have found a relationship between high vitamin E intake and reduced incidence of heart at- tacks. Other studies have found that vitamin E can have a protective effect by preventing LDL from being oxidized into a more harmful form. However, clinical studies have not demonstrated that vitamin E supplements are safe and effective for long-term use (see Chapter 11). Vitamin E has an anticoagulant effect, which means that supplementation may increase the risk of hemorrhagic stroke. Beta-carotene has also been recommended for its antioxidant effect. But long-range studies have found that it is no more effective than a placebo. The most notable of these was the Physicians’ Health Study56 in which 22,000 men taking either beta-carotene or a placebo were followed for 12 years. In 2003, researchers at the Cleveland Clinic57 con- cluded that long-term supplementation with vitamin E or beta-carotene had not been proven beneficial in preventing cardiovascular disease. They reached this conclusion after analyzing seven randomized, controlled trials of vitamin E treatment and eight of beta-carotene treatment, all of which included at least 1000 patients. The dosage ranged from 50 to 800 IU for vitamin E and 15 to 50 mg for beta-carotene, and follow-up ranged from 1.4 to 12 years. The vitamin E trials involved a total of 81,788 patients, and the beta-carotene trials involved 138,113. Compared with control treatment, vitamin E did not increase the overall death rate or significantly decrease the risk of cardiovascular death or stroke. Beta- carotene led to a small but significant increase in overall deaths and a slight increase in cardiovascular death. Thus, although epidemiologic evidence has suggested that these antioxidant supplements may be beneficial, clinical trials have found otherwise. No study has evaluated whether any combinations of vitamin E, garlic, fish oil, ginkgo, and aspirin—all of which can have anticoagulant effects—are safe for long-term use.
Personal Glimpse
Cholesterol Scam What could be more timely than a product to reduce blood cholesterol while still allowing you to eat whatever you please? A full-page ad published in 1989 in more than 100 newspapers claimed that Cho Low Tea would do exactly that. “Don’t cut out your favorite foods,” the ad advised. “New Tea from China Reduces Cholesterol. Medical studies prove it! Just drinking this refreshing tea every day is as effective as medically prescribed drugs. . . . Cho Low is a rare species of tea grown in China for centuries. Traditionally, the Chinese drink it after every meal as a diet aid. Recently . . . researchers were astonished to discover that besides aiding weight loss, Cho Low Tea has natural cholesterol-reducing properties. . . . And you get none of the possible side effects of . . . cholesterol- reducing drugs.” The ad contained endorsements from seven medical sources and the logo of the Better Busi- ness Bureau. The tea cost $29.85 for a 30-day supply. Fortunately for consumers, a newspaper credit bureau executive became suspicious and alerted law enforce- ment agencies in California, where the promotion was based. It turned out that the claims were false and the endorsements were complete fabrications. In fact, “Cho Low Tea” did not exist. The perpetrators said that they had planned to repackage another tea but were arrested before they could do so. After pleading “no contest” to false and misleading advertising, they were sentenced to brief jail terms followed by 3 years’ summary proba- tion. More than 50,000 people had placed orders, but the authorities acted so swiftly that none of them lost money. The scam was masterminded by Peter Foster, an Australian who has been prosecuted civilly and crimi- nally and imprisoned several times in Australia and the United Kingdom for other schemes. The most recent case involved a bogus “diet pill” called TRIMit. In 2005, an Australian court fined him $150,000 and banned him from participating in any weight-loss, cosmetic or health industry-related business for 5 years.
319Chapter Fifteen Cardiovascular Disease
Fiber pills have no proven value for lowering cho- lesterol. Although dietary fiber can play a valuable role in a cholesterol-control program, the amount of fiber in these pills is not significant. High-fiber candy bars contain more but cost much more than ordinary foods. Coenzyme Q10 is described in books and pamphlets as a “miracle nutrient” effective against high blood pressure, heart failure, angina pectoris, high blood cho- lesterol, diabetes, and many other problems. Research with animals has shown that coenzyme Q10 can help protect hearts against transient decreases in the amount of oxygen that cells receive. Some researchers hypoth- esize that coenzyme Q10 can function as an antioxidant. The American Heart Association58 states that insufficient data exist to recommend it for treating angina pectoris or heart failure. Lecithin has been claimed to lower cholesterol but has not been scientifically demonstrated to do so.59 Several companies have marketed products made from red yeast rice as “dietary supplements.” These products contain modest amounts of lovastatin, the ac- tive ingredient in the prescription drug Mevacor, but the dosage is not standardized. However, the FDA has determined that the products do not fit the definition of a dietary supplement, and it has issued several warning letters and gone to court to stop their marketing. The FDA’s action is sensible because optimal cardioprotective programs must include a risk-factor analysis and an individually tailored plan that is devised with professional help. In addition, the products are not standardized, which means that it may be difficult or impossible to determine an optimal dosage. In 2001 the U.S. District Court for the District of Utah affirmed that red yeast rice products that contain significant amounts of lovastatin are subject to regulation as drugs and are not dietary supplements.60 The Medical Letter61 has cautioned that some products contain citrinin, a toxin that can cause kidney failure. Guggulsterone, the active ingredient in the Indian herbal guggulipid, may interfere with many prescription products, including popular anti-cholesterol drugs. In a laboratory study of liver cells, researchers found that guggulsterone induces changes in certain cells that help the body break down certain drugs. Thus it has the poten- tial to raise blood levels of these drugs and produce toxic reactions.62 In 2003, another research team reported that 8 weeks of treatment with standardized guggul extract (2.5% guggulsterones) did not improve levels of serum cholesterol and might raise levels of LDL cholesterol. The product probably also caused a skin rash in some
patients. The study involved 103 adults with high blood cholesterol levels who took 1000 mg or 2000 mg of guggulipid or a matching placebo three times a day.63 Alcohol consumption has been studied because it has been shown that drinking alcoholic beverages can raise the level of HDL. Research has also shown that the incidence of coronary artery disease is lower among moderate drinkers than it is among the abstinent.64 How- ever, the findings are not applicable to young adults and it is unclear whether it is advisable for older adults to begin using alcohol with the hope of producing a health benefit.65 “Moderate intake” has been defined as up to two drinks per day for men and one for women, with a drink defined as 1.5 ounce of hard liquor, 5 ounces of wine, or 12 ounces of beer. Excessive alcohol intake can raise blood pressure; injure the brain, heart, and liver; and cause many other problems. Oil derived from medium-chain triglycerides (MCTs) has been promoted as an alternative to olive or canola oil. It allegedly provides athletes with an energy boost without raising their serum cholesterol level. However, researchers at the University of Texas have demonstrated that the body converts MCTs into long-chain triglycerides, which do raise LDL cholesterol levels.66 Sterol-enriched margarines (Benecol and Take Con- trol) can decrease intestinal absorption of cholesterol. If used 2 to 3 times a day, they can lower high LDL cholesterol levels by 10% to 15%. However: (a) they cost much more than ordinary margarines, (b) they have less effect in people with normal or slightly elevated levels, (c) their effect on the rates of death and illness from CHD is unknown, and (d) the beneficial effects of lowering cholesterol might be offset by increased plasma concentrations of plant sterols, which may foster atherosclerosis.67
Enforcement Actions In 2003, United Therapeutics Corporation and its subsidiary Unither Pharma, Inc., of Silver Spring, Maryland, agreed to settle Federal Trade Commission (FTC) charges that they made deceptive advertising claims for their HeartBar brand products, which are edible bars or powders whose ingredients include 3 to 6 g of L-arginine; soy isoflavones extract; vitamins A, B6, B12, C, and E; niacin; folate; iron; and calcium. The settlement prohibits further unsubstantiated claims that these or other L-arginine-based products reduce the risk of developing heart disease, reverse damage to the heart, reduce or eliminate heart disease patients’ need
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for surgery and medications, and substantially decrease leg pain in people with cardiovascular disease.68 In 2005, the FTC obtained a consent order barring Tropicana, Inc., from claiming that drinking 2 to 3 cups of Tropicana orange juice each day would lower systolic blood pressure by 10 points, raise HDL cholesterol by 21%, and lower blood homocysteine levels by 11%. The FTC noted that although foods such as orange juice that are rich in potassium and low in sodium can help reduce the risk of hypertension and stroke, the specific advertising claims were unsubstantiated.69
high Blood pressure
Blood pressure is the force created by the heart as it pushes blood throughout the circulatory system. High blood pressure (hypertension) is defined as blood pres- sure that is persistently higher than normal. Hyperten- sion is sometimes called “the silent disease” because it produces no symptoms until it reaches an advanced state. (Actually, atherosclerosis is equally silent.) High blood pressure often is detected during a routine medical visit or a screening program. However, because blood pres- sure levels have some natural variability, the diagnosis cannot be established with a single reading; it should be based on the average of two readings at each of two or more medical visits.70 About 75 million Americans have high blood pres- sure. It tends to rise as people get older and is more common among blacks than among whites. Data from the Framingham Heart study suggest that individuals with normal pressure at age 55 have a 90% lifetime risk for developing hypertension.71,72 However, since 1972, age-adjusted death rates from stroke and coronary heart disease have declined by about half because of improve- ments in prevention and treatment.73 When hypertension is caused by kidney disease, a tumor, or another identifiable condition, curing the cause usually will cure the problem. However, in the vast majority of cases, there is no identifiable cause, and the condition is called essential hypertension. When blood pressure is high, the heart must work harder than normal to pump blood throughout the body. The strain often causes the heart to enlarge, promotes atherosclerosis, and can interfere with the blood supply to the kidneys, heart, or brain, leading to kidney failure, heart attack, or stroke. Early treatment is important to reduce the likeli- hood of these complications. In recent years, clinical trials have demonstrated that effective treatment can significantly lower the incidence of heart disease and stroke.
Diagnosis of Hypertension Blood pressure varies somewhat during the course of a day. It usually is lowest when resting and higher as activity increases. It also can increase when people are nervous about having it tested, a condition referred to as “white-coat hypertension.” For this reason it is important to be relaxed when blood pressure readings are taken. Transient elevations usually do not indicate disease or abnormality. For accurate measurement in a doctor’s office, the equipment must be properly calibrated. The patient should be seated quietly for at least 5 minutes in a chair, with feet on the floor, and arm supported at heart level. When the pressure is determined by listening over the artery inside the elbow with a stethoscope, the systolic pressure is the point at which the first of two or more sounds is heard and the diastolic is the point just before the disappearance of the sounds. Blood pressure is expressed as a fraction. Systolic pressure, which is the numerator, reflects the pressure (in millimeters of mercury) when the heart contracts. Diastolic pressure, the denominator, reflects the pres- sure between beats. Table 15-6 summarizes the current classification of blood pressure levels for adults older than 18 years when professionally measured. People who measure themselves at home are generally considered to be hypertensive if their average pressure is greater than 135/85. Devices for home use can be selected with help from one's personal physician and the latest test information from Consumer Reports. The optimal pressure with respect to cardiovascular risk is below 120 systolic and 80 diastolic. The goals of treatment are diastolic pressure below 90, systolic pressure below 140, and control of other modifiable cardiovascular risk factors.
Nondrug Therapy For mild hypertension, nondrug treatment should be tried first. The following measures may help:
• Weight reduction. Losing weight usually results in some lowering of blood pressure.
• Smoking cessation. Cigarette smoking raises blood pressure because nicotine causes arteries to constrict.
• Increasing exercise. As noted in Chapter 13, aerobic exer- cise can lower blood pressure, help people lose weight, and increase HDL. The American College of Sports Medicine has concluded that endurance exercise training will elicit average reductions of 7.5 mm Hg for hypertensive individu- als and 2.6 mm Hg for normal-pressure individuals.74
• Limiting alcohol intake. Individuals who consume 6 ounces or more of alcohol per day are twice as likely as nondrinkers
321Chapter Fifteen Cardiovascular Disease
to have high blood pressure. Hypertensive individuals should drink no more than 2 ounces daily.
• Reducing sodium intake. Some people with high blood pressure will benefit from lowering their sodium intake. The treating physician should provide dietary instructions and a protocol to test this possibility.
• Reducing caffeine intake. Since caffeine can temporarily raise blood pressure, reducing or eliminating caffeine could be tried.
Nearly all hypertensive people can lower their blood pressure to some extent by improving their lifestyle. The benefit depends on how much they change and how high their initial pressure was. The Dietary Approaches to Stop Hypertension (DASH) studies have demonstrated that a diet rich in fruits, vegetables, and low-fat dairy products and with reduced saturated and total fat can achieve reductions comparable to the effects of antihypertensive single-drug therapy seen in many treatment trials. The first study75 involved 459 adults with systolic blood pressures of less than 160 mm Hg and diastolic blood pressures of 80 to 95 mm Hg. Among the hypertensive patients, systolic pressure was reduced by an average of 11.4 mm Hg and diastolic pressure was reduced by an average of 5.5 mm Hg. The second DASH study76 examined the effect of dietary sodium reduction on 412 people who followed either the DASH eating plan or an eating plan typical of what many Americans consume. Their systolic blood pressures were 120 to159 mm Hg and their diastolic blood pressures were 80 to 95 mm Hg. About 41% of them had high blood pressure. The participants were randomly assigned to one of the two eating plans then followed-up for a month at each of three sodium intake levels: 3300 mg/day (the level consumed by many Americans), 2400 mg/day, and 1500 mg/day. The study found that reducing dietary sodium lowered blood pres- sure for both groups of participants but reduced it more consistently with the DASH eating plan. The biggest
reductions were seen with the DASH plan and a sodium intake of 1500 mg/day. Those with hypertension did best, but those without it also had large decreases. Thus the DASH diet may represent an alternative to drug therapy for people with prehypertension or Stage 1 hypertension who are willing to comply with the diet. Additional information about the diet is available on the National Heart, Lung, and Blood Institute Web site (www.nhlbi. nih.gov/health/public/heart/hbp/dash).
Drug Therapy If nondrug measures are unable to normalize blood pres- sure after a suitable trial period, drug treatment should be used. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure72 has concluded that thiazide-type diuretics should be used as the initial therapy for most hyperten- sive patients, either alone or in combination with other proven drugs. The factors influencing the choice of drug include the extent of the problem, the presence of other health problems, the patient’s tolerance of the drugs, side ef- fects, and cost. Side effects can include fatigue, head- aches, palpitations, dizziness, loss of sexual desire, and other less common symptoms. Cost varies according to the drug selected, the dosage and frequency used, the availability of a generic version, and the pharmacist’s markup. The cost ranges from a few cents a day for ge- neric thiazide-type diuretics to several dollars per day for some of the newer brand-name drugs. Some people with mild hypertension are able to discontinue medication safely if they lose weight and modify other lifestyle risk factors, but most individuals with moderate or severe hypertension should continue taking it for life.
Risk Factors for Stroke A stroke occurs when an artery to the brain bursts or becomes clogged by a blood clot or other particle. (Strokes caused by clots or particles are more common than hemorrhaghic strokes.) Deprived of oxygen, nerve cells in the affected area of the brain cannot function and die within minutes, resulting in loss of function in the parts of the body that are controlled by these cells. The primary risk factors for stroke include hereditary predisposition, high blood pressure, heart disease, cigarette smoking, obesity, being male, advancing age, and diabetes. Secondary risk factors, which contribute to the development of heart disease, include lack of exercise, excessive alcohol intake, and abnormal blood cholesterol levels.
ClassifiCaTion of Blood pressure levels
Table 15–6
Category Systolic BP Diastolic BP Normal Less than 120 and Less than 80 Prehypertension 120–139 or 80–89 Stage 1 hypertension 140–159 or 90–99 Stage 2 hypertension 160 or more or 100 or more
Modified from Seventh Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure.72
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Stroke Warning Signs Blockage of the blood supply to the brain is a medical emergency. The American Stroke Association lists the following warning signs and advises calling 911 if any of the following suddenly occur:
• Numbness or weakness of the face, arm, or leg, especially on one side of the body
• Confusion, trouble speaking or understanding • Trouble seeing in one or both eyes • Trouble walking, dizziness, loss of balance or coordination • Severe headache with no known cause
Transient ischemic attacks (TIAs) are “warning strokes” that produce stroke-like symptoms but no lasting damage. A person who has had one or more TIA is almost 10 times more likely to have a stroke than someone of the same age and gender who hasn’t. Recognizing and treating TIAs can reduce the risk of a major stroke. For this reason, they warrant immediate medical attention.
hearT aTTaCKs
The American Heart Association estimated that in 2006, about 945,000 Americans had a heart attack and about 15% of them died as a result.1 About half of heart attack victims die before they reach a hospital. Heart attacks are typically caused by a blood clot that blocks a seg- ment of coronary artery narrowed by atherosclerosis. The resultant lack of blood can cause damage or death to part of the heart muscle, a condition called myocardial infarction. The typical symptoms are:
• Uncomfortable pressure, fullness, squeezing, or pain in the center of the chest that lasts more than a few minutes.
• Pain spreading to the shoulders, neck, jaw, or arms, par- ticularly the left arm.
• Chest discomfort with lightheadedness, sweating, nausea, and/or shortness of breath.
Not all of these warning signs occur in every heart attack. People who experience them, however, should seek help as soon as possible because early medical intervention can often save a person’s life and reduce the amount of damage done to the heart. The American Heart Association advises consumers to know which area hospitals provide 24-hour emergency cardiac care and to call an emergency rescue service if the above symptoms of chest discomfort persist for 10 minutes or longer. Angina pectoris is a condition in which blood supply to the heart is temporarily inadequate to meet the body’s needs. It is typically precipitated by exertion. The dis- comfort of angina can be similar to that of a heart attack
but subsides within a few minutes when the individual rests or takes medication (nitroglycerin) that increases the blood supply to the heart. Recurrent attacks indicate that the risk of a heart attack may be high. Medication that dilates coronary arteries often can prevent or reduce the incidence of angina attacks. In properly selected individuals, coronary bypass surgery or angioplasty (discussed later in this chapter) is corrective.
Hospital Care A myocardial infarction is a medical emergency because it can cause an abnormal heart rhythm that results in sudden death. What takes place within the first few hours may make the difference between life and death, or between recovery and disability. For this reason, it is advisable for the distressed person to be transported to a hospital facility as soon as possible. The best way to reach the hospital will depend on the individual’s situation and location. In many com- munities calling 911 immediately is the best choice. If not, calling an ambulance or being driven by someone else is safer than driving oneself. Research has shown that getting an aspirin early in the treatment of a heart attack, along with other treatments that emergency medical technicians and emergency department physicians provide, can signifi- cantly improve the odds for survival.77 If the patient is not allergic to aspirin, the 911 operator or emergency physician may advise taking a tablet. Hospital care for a heart attack has five basic goals: (1) to prevent sudden death, (2) to determine the location and extent of the problem, (3) to minimize damage to the heart muscle, (4) to prevent and treat complications, and (5) to enable the patient to return to as normal a lifestyle as possible. Upon arrival at the hospital the patient is connected to a device that provides a continuous electrocardiogram (ECG) on an oscillograph screen that staff members monitor. Anticoagulant therapy may be administered to prevent additional blockage from the blood clot. In some cases it is possible to locate and remove the blockage with clot-dissolving medication and/or surgery. To take advantage of new developments, it is advisable to obtain care from an up-to-date cardiologist who practices in a well-equipped hospital.
diagnosTiC TesTs
The tests used to evaluate the structure and function of the heart and its blood supply vary considerably in complexity and cost. A physical examination includes
323Chapter Fifteen Cardiovascular Disease
measurement of the pulse, which provides information about the heart’s rate and rhythm, and listening to the heart with a stethoscope, which can reveal murmurs that signify abnormalities of the heart valves. A chest x-ray can detect abnormal enlargement of the heart, which can have a variety of causes. Blood tests may be done to measure the levels of cardiac enzymes that rise when heart muscle damage occurs. Electrocardiogram The best known and most widely used test of heart func- tion is the electrocardiogram, commonly referred to as an ECG or EKG. This test, which usually costs from $100 to $150, measures the flow of tiny electrical currents that change as the heart beats. It is painless, does not put any electricity into the body, and merely amplifies a signal that is already there. It is usually performed with the patient lying down, with wires (leads) connected from the patient to the device. The device prints a representa- tion of the electrical activity on graph paper so it can be interpreted by a physician (Figure 15-4). ECGs are especially useful for diagnosing distur- bances of heart rhythm. When a rhythm disturbance is intermittent, a portable device (Holter monitor) that makes a continuous record for at least 24 hours may be needed to demonstrate the abnormality. For less-frequent problems, the patient can wear a device for several weeks that the patient activates when symptoms occur. The results are then transmitted by telephone to a company that interprets what is recorded. ECGs are also useful for detecting damage to heart muscle tissue, as occurs in a heart attack, but a normal report does not guarantee that the heart is normal. Fol- lowing a heart attack, it may take several hours for abnormal changes to show up on the cardiogram. It is also possible for muscle damage to occur in a part of the heart that a routine ECG procedure does not discern.
Blood tests for markers of cardiac tissue damage, such as creatine kinase-MB fraction and troponin, are used together with serial ECGs to diagnose heart attacks. Every person with suspected or diagnosed coro- nary artery disease should have an ECG as part of an initial coronary evaluation. The test should be repeated as needed, but there is controversy about how often it should be done in people who have no symptoms. In people without heart disease, findings considered suspi- cious may lead to unnecessary studies, but it is useful to have a baseline ECG tracing in the patient’s medical record for comparison if symptoms develop later.
Stress Tests A stress test (also referred to as an exercise test or tread- mill test) involves monitoring a patient’s ECG, blood pressure, and symptoms during gradually escalated exercise (typically on a treadmill) or during stimulation of the heart by a drug. It is useful for detecting unsus- pected abnormalities of the heart or to help determine the amount of exercise that can be tolerated by an individual with known heart disease. Exercise testing is not appropriate for routine use for people who feel well, because it costs several hundred dollars and often yields false-positive results that trigger even greater expense and intrusive follow-up testing. Testing is likely to be appropriate under the following circumstances: • Following a heart attack or heart surgery; used to help deter- mine the prognosis and an appropriate heart-strengthening exercise program.
• Sedentary men ages 45 or older and women 55 or older who plan to start an exercise program more intense than walking at 50% to 60% of maximum heart rate. However, a gradual and sensible exercise program outlined by a physi- cian is a reasonable alternative. Testing could then be done if symptoms such as chest discomfort or lightheadedness develop.
• People (such as airline pilots) whose health is crucial to the safety of others.
• Coronary occlusion or other evidence of CHD before the age of 55 in a close blood relative.
• Cigarette smoking, high blood pressure, diabetes, or obesity.
• Chest pain or other symptoms of CHD during exertion.
In a nuclear stress test, radioactive thallium or sesta- mibi is injected into an arm vein and scanning provides images of blood flow to the heart with and without exercise. It is more accurate than a plain stress test but is far more expensive and involves a small exposure to radiation. It can help with diagnosis if a regular stress test is equivocal, and it can be used to assess progress after a cardiac rehabilitation program.
figure 15-4. Normal electrocardiogram. The circled area represents the electrical events related to one heartbeat.
Part Four Personal Health Concerns324
An exercise test entails slight risk. The risk of trig- gering a heart attack is less than 1 in 500, and the risk of dying is less than 1 in 10,000. For this reason, testing should be performed in a facility equipped to handle any emergency that may arise, and a physician and at least one technician trained in advanced life support should be present.
Cardiac Catheterization Cardiac catheterization with angiography is used to evaluate blood flow to the heart and visualize the loca- tion of narrowed or blocked coronary arteries. It is more accurate than a stress test, but it is more expensive and entails a slightly higher risk of provoking a heart attack. The patient is usually awake but sedated and is given local anesthetic at the catheter insertion site; very little discomfort is involved. A small diameter hollow plastic tube (catheter) is inserted into an artery through a tiny skin incision in the groin or wrist and threaded up to the heart, where a dye is injected into the coronary arteries, allowing the pattern of blood supply to the heart muscle to be visualized and recorded in x-ray videos. Coronary angiography can be done as an inpatient or outpatient procedure; it usually costs from $2000 to $3500 or more. The American Heart Association estimates that about 1.1 million such procedures were performed in 2006.1
Ultrasound Testing Echocardiography uses ultrasound waves to visualize the heart. It is used to gather information about the functioning of heart valves and the structure and func- tioning of the heart muscle. Images are observed on a screen and photographed for later study. Echo stress testing combines echocardiography and exercise testing in order to detect less-than-normal contraction of heart muscle related to lack of coronary artery circulation to part of the heart.
Computer Imaging Tests Several computer imaging tests are available. Computed tomography (CT or CAT scans) provide detailed x-ray images of one “slice” of the body at a time. Radionuclide tests, such as thallium tests or MUGA scans, use injected radioactive materials to picture the heart’s function and blood supply. Magnetic resonance imaging (MRI) and nuclear magnetic resonance imaging (NMR) generate high-resolution pictures of anatomical structures using powerful magnets but no radiation. Digital cardiac an- giography or digital subtraction angiography (DCA or DSA) compares x-ray images before and after injection
of a dye. Positron emission tomography (PET scans) combines CT with radioactive tracers. Single photon emission computed tomography (SPECT scans) shows where a radioactive tracer appears. These are specialized tests that may be ordered when a diagnosis is in doubt or more information is needed. (See Chapter 5 for further information on imaging tests.) Ultrafast computed tomography (ultrafast CT) scan- ning—also called electron-beam computed tomography (EBCT)—combines electrocardiography with CT scan- ning so that the heart is imaged only during a particular moment within each cycle of the heartbeat. The resultant images show whether the coronary arteries contain cal- cium deposits.78 These deposits correlate with the degree of atherosclerosis and can be reported as a “calcium score.” Further testing—usually angiography—might then be performed to pinpoint the extent of disease. If an ultrafast CT scan is negative, the individual has a low probability of having coronary artery disease. However, the test is expensive and yields many false- positive results that can lead to further unnecessary expense. For this reason, EBCT screening is not rec- ommended by the U.S. Preventive Services Task Force and is not covered by medical insurance. The American College of Cardiology79 has identified a few circum- stances in which the test may be useful, but screening symptom-free individuals is not among them.
Dubious Marketing to Consumers In recent years, some facilities have been offering x-ray and ultrasound screening tests that consumers can order for themselves. Some marketers advertise examples of people whose lives were supposedly saved by early discovery of a problem. EBCT has also been promoted by Oprah Winfrey, who has urged her viewers to learn their coronary calcium scores. However, routine use of these tests has not been proven to be cost-effective or to have better predictive value than standard risk-factor assessments. In addition, this kind of screening can lead to false-positive results, unnecessary worry, and unnecessary invasive testing and can also lead to false reassurances that no disease is present. It is far more prudent for consumers who are con- cerned about their heart to seek medical advice rather than to guess about what tests might be useful.
surgerY To resTore Blood floW
The heart normally receives its blood supply from the coronary arteries, which connect from the aorta to the heart muscle. If these become clogged near their origin
325Chapter Fifteen Cardiovascular Disease
but are open beyond that point, it may be possible to restore the blood supply with a surgical procedure.
Coronary Bypass In coronary bypass surgery (also referred to as coronary artery bypass graft surgery, or CABG), one or more grafts are connected from the aorta to the unblocked portions of the coronary arteries. The grafts may be obtained from the patient’s mammary artery (which supplies a por- tion of the chest wall but is not vital to the area) and/or saphenous veins, which serve the lower part of each leg. During the operation, the patient’s heart is stopped so the grafts can be sewn in place while circulation is maintained by a heart-lung machine. If no complica- tions occur, most patients will be discharged from the hospital within 1 week and recuperate at home for a few months. CABG can provide dramatic relief for many people with angina and may also be used to restore blood flow following coronary thrombosis. In properly selected patients, CABG can prolong life, particularly for those able to reduce their risk factors. Chelation therapy is promoted as an alternative to bypass surgery, although there is no evidence that it is
effective (see Chapter 8). Some chelationists even ad- vertise that people advised to undergo bypass surgery should have chelation therapy instead. This advice is extremely dangerous. Angioplasty During the past two decades there has been extraordi- nary progress in the development of instruments and procedures that can to unclog arteries from within. The most widely applicable of these procedures is balloon angioplasty, the medical term for which is percutaneous transluminal coronary angioplasty (PTCA). In this procedure a very thin wire is placed into the femoral artery in the thigh and threaded into a coronary artery while the cardiologist watches the wire’s progress on an x-ray monitor. Then a guide catheter, a flexible tube with a diameter about the thickness of a pencil, is passed over the wire and a second catheter tipped with a deflated balloon is threaded through the guide catheter. When the balloon reaches the blockage, it is inflated to compress atherosclerotic plaque against the inner artery walls. The balloon is then deflated and withdrawn together with the guide wire and catheter. Other angioplasty tools include motorized devices that shave, drill, or pulverize
√ Consumer Tip
Advice to Consumers Atherosclerosis and high blood pressure develop silently for many years before causing trouble. The difficulty they cause can be prevented or minimized by the following actions:
1. Know the risk factors for atherosclerosis and hypertension and take steps to minimize them. Table 15-2 provides a convenient summary and checklist for evaluating the status of your risk factors.
2. Do not smoke cigarettes. Smokers develop a much higher incidence of heart disease, stroke, and many cancers. 3. Maintain a reasonable weight. Be particularly concerned about developing fatty deposits around the waist (see
discussion of waist-hip ratio in Chapter 12). 4. Follow the dietary guidelines in Chapter 10. Eat a balanced diet that is low in fat, particularly saturated fat, adequate
in fiber, and moderate in sodium. This will not only help prevent cardiovascular disease but also may help prevent certain cancers.
5. Engage in regular aerobic exercise as outlined in Chapter 13. Exercise can lower total cholesterol and LDL and raise HDL.
6. Have your blood pressure checked at least once a year and take appropriate action if it becomes elevated. 7. Know your “cholesterol number.” Have your level checked through a doctor’s office and take appropriate action
according to the protocols of the National Cholesterol Education Program. If your cholesterol level is high or borderline high, seek expert guidance from a physician who maintains an interest in this subject and pays close attention to recent developments. Usually this can be determined by asking about the physician’s level of interest.
8. Do not consume unproven dietary supplements such as fish oil or beta-carotene, but eat fish once or twice a week and have adequate amounts of fruits, vegetables, and whole-grain foods in your diet.
9. If you develop significant cardiovascular disease, seek help from a cardiologist. 10. If you require an invasive diagnostic procedure (such as angiography) or cardiac surgery, select a cardiologist or
surgeon who has had adequate experience and works in an up-to-date hospital facility.
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diabetes, obesity, lack of physical activity, and abnormal blood cholesterol levels. The more risk factors a person has, the greater the risk of developing heart disease. Heredity, gender, and age cannot be controlled, but the other risk factors can be influenced by the individual’s behavior. Medical authorities recommend that all adults have their blood cholesterol and blood pressure checked and take action if abnormal elevations are found. The corner- stone of a cholesterol-reduction program is a balanced, low-fat, high-fiber diet plus regular aerobic exercise. These measures may also be effective in lowering high blood pressure. If nondrug methods are insufficient, drug therapy may be advisable—often on a lifetime basis. Great progress has been made in both medical and surgical treatment of cardiovascular disease. More research is needed to evaluate newer techniques. If problems arise, expert guidance should be sought from a physician who is well trained and pays close attention to recent developments.
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2. American Heart Association. Heart Disease and Stroke Statis- tics—2010 Update At-A-Glance. Dallas, 2010, The Association.
3. Pearson TA and others. Markers of inflammation and cardiovas- cular disease application to clinical and public health practice. Circulation 107:499–511, 2003.
4. He J and others. Passive smoking and the risk of coronary heart disease—A meta-analysis of epidemiologic studies. New England Journal of Medicine 340:920–926, 1999.
5. Willett WC and others. Coffee consumption and coronary heart disease in women: A ten-year follow-up. JAMA 275:458–462, 1996.
6. Triglycerides and heart disease. Harvard Heart Letter 11(1):1–5, 2000.
7. Barrett S. Does lowering homocysteine prevent cardiovascular disease? Quackwatch Web site, June 26, 2010.
8. Nusselder WJ and others. Living healthier for longer: Compara- tive effects of three heart-healthy behaviors on life expectancy with and without cardiovascular disease. BMC Public Health 9:487–495, 2009.
At your doctor’s suggestion, you have a lipid analysis, which shows an LDL level of 135 and an HDL of 40. The doctor says that these levels suggest that your risk of a heart attack is above average. What actions should you consider?
It’s Your Decisionplaque, and laser devices that vaporize it. In many cases a small tube (stent) is left within the artery to maintain the opening. Angioplasty is also used to open arteries in the kidneys, arms, and legs. “Drug-eluting” stents are coated with a drug that is gradually released to interfere with reclogging. In many cases angioplasty provides an alternative to coronary bypass surgery. It costs much less, requires a shorter hospital stay, and has a short recovery period, but it the likelihood of reclogging is greater. About 450,000 bypass operations and 1.3 million angioplasties were performed during 2006.1 Questions have been raised about whether these procedures are performed too often, but there are no simple answers.
CardiaC rehaBiliTaTion prograMs
After cardiac surgery or recovery from a heart attack, it is important to take steps to restore function and prevent recurrence. Lack of activity, lack of sleep, medication, the surgery itself, and the stress of being ill can leave pa- tients feeling drained, physically and emotionally. Many hospitals and clinics have established programs to help restore the ability to function. These programs provide gradually escalated exercise, dietary counseling, and attention to the individual’s risk factors. A cardiologist performs an exercise test to determine the individual’s exercise tolerance and prescribes an exercise program. Then the exercise is done several times a week while the patient is monitored by a specially trained nurse. The patient wears a device that broadcasts an ECG to an oscillograph observed by the nurse. If the patient’s pulse rises too high or the ECG shows signs that the heart is straining, the patient is advised to slow down or stop. Patients are taught how to monitor their pulse and have the opportunity to use many types of exercise equipment. Most programs involve three sessions a week for 12 weeks. After that, if all goes well, the patient has learned how to perform heart-strengthening aerobic exercise and will continue a home program indefinitely.
suMMarY
Cardiovascular diseases are the leading cause of illness and death in the United States. The majority of cases stem from atherosclerosis, a condition in which cholesterol, fat, and fibrous tissue build up in the walls of large and medium-sized arteries. The important risk factors for coronary heart disease include hereditary predisposition (a family history of premature heart disease), being male, advancing age, cigarette smoking, high blood pressure,
327Chapter Fifteen Cardiovascular Disease
9. Angermayr L and others. Multifactorial lifestyle interventions in the primary and secondary prevention of cardiovascular disease and type 2 diabetes mellitus—A systematic review of randomized controlled trials. Annals of Behavioral Medicine 40:49–64, 2010.
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14. Samuelson O and others. Cardiovascular morbidity in relation to change in blood pressure and serum cholesterol levels in treated hypertension. JAMA 258:1768–1776, 1987.
15. Gotto AM Jr and others. The cholesterol facts—a joint state- ment by the American Heart Association and the National Heart, Lung, and Blood Institute. Dallas, 1990, American Heart Association.
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17. Danesh J and others. Lipoprotein(a) and coronary heart disease. Meta-analysis of prospective studies. Circulation 102:1082– 1085, 2000.
18. Maher VM and others. Effects of lowering elevated LDL cholesterol on the cardiovascular risk of lipoprotein(a). JAMA 274:1771–1774, 1995.
19. Ridker PM and others. Plasma concentration of lipoprotein(a) and the risk of future stroke. JAMA 273:1269–1273, 1995.
20. Grundy SM and others. Third Report of the National Choles- terol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). NIH Publication No. 01-3670. Washington, D.C., 2001, Supt. of Documents.
21. Grundy SM and others. Implications of recent clinical trials for the National Cholesterol Education Program Adult Panel III guidelines. Circulation 110:227–239, 2004.
22. Lichtenstein AH. Trans fatty acids, plasma lipid levels, and risk of developing cardiovascular disease: A statement for health professionals. Circulation 95:2588–2590, 1997.
23. Food labeling: Trans fatty acids in nutrition labeling; final rule. Federal Register 68:41433–41506, 2003.
24. Rimm EB and others. Vegetable, fruit, and cereal fiber intake and risk of coronary heart disease among men. JAMA 275:447–451, 1996.
25. Hu FB, Willet WC. Optimal diets for prevention of coronary heart disease. JAMA 288:2569–2578, 2002.
26. Barnard RJ. Effects of life-style modification on serum lipids. Archives of Internal Medicine 151:1389-1394, 1991.
27. Mirkin G, Rich D. Fat Free, Flavor Full. Boston, 1995, Little, Brown and Company.
28. Newman B, Hulley SB. Carcinogenicity of lipid-lowering drugs. JAMA 275:55–60, 1996.
29. Dalen JE, Dalton WS. Does cholesterol lowering cause cancer? JAMA 275:67–68, 1996.
30. Lichtenstein AH and others. Diet and lifestyle recommendations revision 2006: A scientific statement from the American Heart Association Nutrition Committee. Circulation 114:82–96, 2006.
31. Taubes G. Good Calories, Bad Calories: Fats, Carbs, and the Controversial Science of Diet and Health. New York, 2007, Anchor Books.
32. Hall HA. Why we get fat. Science-Based Medicine Blog, Jan 18, 2011.
33. USDA food composition data. USDA Nutrient Data Laboratory Web site, accessed May 23, 2005.
34. Theuwissen E and others. Water-soluble dietary fibers and cardiovascular disease. Physiology and Behavior 94:285–292, 2008.
35. Barrett S. Tips for lowering your dietary fat content. Quackwatch Web site, April 6, 2011.
36. Kris-Etherton PM. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation 106:2747–2757, 2002.
37. Omega-3 oil. Fish or pills? Consumer Reports 68(7):30–32, 2003.
38. Cholesterol Treatment Trialists (TTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 ran- domised trials. Lancet 376:1670–1681, 2010.
39. Ornish D and others. Can lifestyle changes reverse coronary heart disease? Lancet 336:129–133, 1990.
40. Gould KL, Ornish D and others. Improved stenosis geometry by quantitative coronary arteriography after vigorous risk fac- tor modification. American Journal of Cardiology 69:845–853, 1992.
41. Gould KL, Ornish D and others. Changes in myocardial per- fusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA 274:894–901, 1995.
42. Ornish D and others. Intensive lifestyle changes for reversal of coronary heart disease. JAMA 280:2001–2007, 1998.
43. Esselstyn CB Jr. Updating a 12 -year experience with arrest and reversal therapy for coronary heart disease (an overdue requiem for palliative cardiology) . American Journal of Cardiology 84:339–341, 1999
44. Esselstyn CB Jr. Prevent and Reverse Heat Disease. New York, 2007, Penguin Group.
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46. Pritikin R. The New Pritikin Program: The Easy and Delicious Way to Shed Fat, Lower Your Cholesterol, and Stay Fit. New York, 1990, Simon & Schuster.
47. Drugs for lipids. Treatment Guidelines from The Medical Letter 9:13–20, 2011.
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49. Henkin Y. Rechallenge with crystalline niacin after drug-induced hepatitis from sustained-release niacin. JAMA 264:241–243, 1990.
50. Etchason JA and others. Niacin-induced hepatitis: A potential side effect with low-dose time-release niacin. Mayo Clinic Proceedings 66:23–28, 1991.
51. McKenney JM and others. A comparison of the efficacy and toxic effects of sustained- vs immediate-release niacin in hy- percholesterolemic patients. JAMA 271:672–677, 1994.
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52. Berger JS and others. Aspirin for the primary prevention of cardiovascular events in women and men: A sex-specific meta- analysis of randomized controlled trials. JAMA 295:306–312, 2008.
53. Hall HA. The International Network of Cholesterol Skeptics. Science-Based Medicine Blog, Feb 5, 2008.
54. Ridker PM and others. Rosuvastatin to prevent vascular events in men and women with elevated c-reactive protein. New England Journal of Medicine 359:2195–2207, 2008.
55. Alder R and others. A systematic review of the effectiveness of garlic as an anti-hyperlipidemic agent. Journal of the American Academy of Nurse Practitioners 15:120–123, 2003.
56. Hennekens CH and others. Lack of effect of long-term supple- mentation with beta-carotene on the incidence of malignant neoplasms and cardiovascular disease. New England Journal of Medicine 334:1145–1149, 1996.
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65. Friedman GD, Klatsky AL. Is alcohol good for your health? New England Journal of Medicine 329:1882–1883, 1993.
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76. Sachs FM and others. Effects on blood pressure of reduced di- etary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. New England Journal of Medicine 344:3–10, 2001.
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CanCer
Suppose someone began marketing automobiles with claims that they can run on water. Most people would want this to be proven and guaran- teed or they would pass up the offer. Yet many people who feel desperate about a health problem are vulnerable to promises from individuals who . . . use methods that are unproven according to the criteria of the scientific community. This type of analogy might help patients place dubious cancer treatment in proper perspective. Helene Brown1
© 1980 stephen barrett, m.d.
Chapter Sixteen
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The term cancer encompasses more than 100 different diseases characterized by abnormal cell growth. The abnormal cells do not function
usefully in the body and can destroy normal tissue. No single form of treatment is best for all types of cancer because each type of tumor has its own characteristics. Since cancer cells are quite similar to normal cells, it is not simple to kill the one while preserving the other. These concepts should be useful in understanding why any method proposed as effective against all cancers should be viewed with great skepticism. Cancer re- searchers do not expect to find such a “magic bullet” in the foreseeable future. Cancer ranks as the second leading cause of death in the United States. The American Cancer Society (ACS)2,3 estimated that in 2011 (a) about 572,000 million Americans would die of cancer, and (b) about 1.6 mil- lion new cases of invasive cancer would be discovered. These figures did not include about 2 million cases of superficial skin cancers that are easily diagnosed and
treated or about 111,000 cases of cancers of the female breast or melanomas that are so small, localized (in situ), and curable that they are tabulated separately. About one out of four deaths in the United States is due to cancer. However, the overall age-adjusted cancer death rate has gradually decreased during the past 40 years. Both prevention activities and improvements in medical care have contributed to this decline. This chapter discusses the risk factors for can- cer, preventive measures, scientific (evidence-based) treatment methods, diet and cancer, susceptibility to quackery, questionable methods, consumer protection laws, and information sources.
avoidable Causes of CanCer
Cancer is the result of a complex interaction of causative agents, both environmental and genetic. The most com- mon direct cause of human cancer is tobacco smoking, which is responsible for 85% to 90% of lung cancer cases as well as cancers of the bladder, mouth, larynx, esopha- gus, pancreas, and possibly other organs.4 Other causes of cancer are related to excessive alcohol consumption, radiation, and certain sexual patterns, infections, drugs, and occupational exposures.5 The effect of diet on cancer is not clearly established. However, epidemiologic studies have found an associa- tion between low intakes of fruits and vegetables and increased incidence of certain cancers. Obesity has been linked to cancers of the colon/rectum, breast (postmeno- pausal), uterus, and kidney. Excessive intake of alcohol increases the risk for cancer of the esophagus, mouth, rectum, liver, and pos- sibly other sites. Smoking multiplies this risk at some sites.
• The most common avoidable cause of cancer is tobacco smoking.
• No evidence exists that food additives increase the risk of cancer in humans, but many naturally occurring food components do. If significant evidence existed that an additive is dangerous, the FDA would ban it.
• In contrast to the epidemiologic evidence on cigarette smoking and cancer, evidence for the influence of dietary factors and cancer is uncertain.
• Antioxidant supplements have not been proven to prevent cancer.
• Treatments promoted with simplistic notions about cancer or with testimonials should be disregarded.
• The National Cancer Institute’s computerized database provides physicians with up-to-date information about cancer treatment. This enables most cancer patients to benefit from current knowledge without having to travel far.
Keep These poinTs in Mind as You sTudY This ChapTer
Key Concepts
Warning Signals The American Cancer Society lists the following cancer warning signals as reasons to consult a physician.
• Change in bowel or bladder habits • A sore that does not heal • Unusual bleeding or discharge • Thickening or lump in breast or elsewhere • Indigestion or difficulty in swallowing • Obvious change in a wart or mole • Nagging cough or hoarseness
√ Consumer Tip
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High-dose exposure to ionizing radiation increases the chances of leukemia and skin cancer. Exposure to high indoor levels of radon increases the incidence of lung cancer, particularly among cigarette smokers. The Environmental Protection Agency recommends that homes with average radon levels of 4 picocuries per liter or greater undergo corrective measures. About 6% of homes in the United States have levels that high.6
Guidance is available from the National Safety Council’s Radon Fix-It Line (800-644-6999). Human papilloma virus (HPV) infection can cause genital warts, about 75% of cervical cancers, and several other types of cancer. The HPV vaccine can sharply re- duce the incidence of these cancers, but, for maximum effect, must be given before sexual activity begins. In the United States, more than 20 million people are infected and about 6 million get a new genital HPV infection each year. Gardasil is approved for preventing cervical, vaginal, and vulvar cancer in females 9 to 26 years old and for preventing genital warts in males 9 to 26 years old. Gardasil does not fully protect everyone or protect against diseases caused by other HPV types or against diseases not caused by HPV. It is given as 3 injections over 6 months. Proponents argue that the only way the vaccination can work as a public health measure is if it is widely used. Opponents claim that its use will endorse and en- courage teenage sexual activity, although no scientific data support that belief. There is also controversy about whether HPV vaccination should be mandated or offered on a voluntary basis.7
Chronic infections with HIV, hepatitis B, and Heli- cobacter pylori (the bacterium that causes peptic ulcers) are associated with increased incidence of other cancers. Ultraviolet rays cause the majority of skin cancers. The principal source is the sun, but indoor tanning de- vices are another source (see Chapter 18). High-dose, long-term exposure to a number of oc- cupational chemicals has been shown to increase the risk of cancer. These include benzene, asbestos used for insulating and fireproofing, and vinyl chloride used in the production of plastics. Despite the presence of carcinogenic substances in the atmosphere, there is no firm evidence that air pollution is a significant cause of cancer. Nor is there any credible evidence or reason to believe that living or working near electric power lines or using cell phones increases cancer risk.8,9
There is no evidence that food additives used in the United States increase the risk of any form of hu- man cancer. A 1996 National Research Council report10
concluded (a) cancer-causing chemicals that occur naturally in foods are far more numerous than synthetic carcinogens, yet both types are consumed at levels so low that they appear to pose little threat to human health; (b) although some chemicals in the diet have the ability to cause cancer, they appear to be a threat only when present in foods that form an unusually large part of the diet; (c) the varied and balanced diet needed for good nutrition seems to provide significant protection from the natural toxicants in our foods; and (d) the human diet contains a mixture of small amounts of thousands of chemicals, some that may cause cancer and some that may help prevent it by acting as anticarcinogens. The National Cancer Institute 11 has concluded that “there is no clear evidence that the artificial sweeteners available commercially in the United States are associated with cancer risk in humans.”
prevenTive Measures
Cancer prevention can take two forms: primary preven- tion (before it occurs) and secondary prevention (discov- ery before symptoms occur). The most important primary preventive measure—probably the most important health decision an individual can make—is to avoid cigarettes and other tobacco products. The American Cancer So- ciety’s dietary recommendations are discussed later in this chapter. Other important measures include regular exercise12 and avoidance of excessive alcohol intake and sun overexposure (see Chapter 18). Secondary prevention attempts to detect and treat cancer in its early stages in order to improve outcome. Secondary prevention measures include periodic physi- cal examinations, Pap smears, sigmoidoscopy, colonos- copy, mammography, and tests to detect blood in the stool. Chapter 5 contains guidelines for frequency of these examinations. Thermography (measuring heat given off by a part of the body) and transillumination (shining of red and near-infrared light through a body part to illuminate its inner structures) are not valid techniques for breast cancer detection.
diagnosis
Although cancer is often suspected because of a physical finding, laboratory test, or imaging procedure, standard practice requires confirmation through microscopic examination by a pathologist. Specimens usually are obtained by biopsy of a small piece of tissue suspected of being cancerous. Cancer diagnosis is sometimes difficult.
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However, although the frequency of diagnostic errors is unknown, it appears low.
prognosis
Once a cancer is identified, the next steps are grading and staging. Grading classifies cancer cells in terms of how abnormal they look under a microscope and how quickly the tumor is likely to grow and spread.13 Stag- ing estimates how far the disease has advanced along its usual course.14 For most cancers this is based on the size of the primary tumor, the involvement of lymph nodes, and the presence of metastases (tumors that have spread to distant sites through the bloodstream or lymphatic channels). Grading and staging are used to help select appropriate treatment, estimate prognosis (probable course), and evaluate treatment results. The National Cancer Institute (NCI) estimates that about 68% of the people diagnosed with cancer are likely to live 5 years or more.3 Its data from 1999 through 2006 include the following 5-year survival rates by sites: uterus, 61% to 86%; larynx, 49% to 65%; breast, 78% to 91%; cervix, 64% to 73%; bladder, 66% to 82%; prostate, 97% to 100%; colon, 55% to 67%; and lung, 13% to 17%. (The lower numbers are for blacks; the higher ones are for whites.) For certain types of cancers that usually occur before age 45, treatment with anticancer drugs has produced a sharp fall in overall death rates and has resulted in long- term survival for many patients. These cancers include Hodgkin’s disease and acute childhood leukemia. The overall survival rates for most other cancers have risen slowly. The outlook for an individual with cancer depends on the type of tumor, its location, and the extent of its spread. Some tumors grow slowly and remain localized, whereas others grow rapidly and metastasize. Sponta- neous remission of certain cancers occurs, although rarely. Learning one’s prognosis can be complicated by the fact that many physicians are reluctant to com- municate bad news. Predictions are often expressed as median survival time, the point at which, for each tumor type and stage, about half the patients will be dead. Some patients think that a median survival time of six months means that they have six months to live. However, half will survive longer, and a few may survive much longer. Researchers who surveyed 13 prominent newspapers and magazines have concluded that (a) stories about can- cer often discuss aggressive treatment and survival but rarely discuss treatment failure, adverse events, end-of-
life care, or death; (b) these portrayals may give patients an inappropriately optimistic view of cancer treatment, outcome, and prognosis; and (c) insufficient attention is paid to how palliative and hospice care compare with “heroic” attempts at cures.15 Goozner16 has observed that “Hopeful stories . . . increasingly come directly from the medical literature, which has a well-oiled machine for getting its most promising ‘breakthrough’ research into the nation’s premier newspapers and news magazines.” Patients with a poor prognosis often face a serious dilemma. In many cases, although surgery, radiation, or chemotherapy might briefly prolong life, the quality of that life (due to side effects or disability) would be so poor that further treatment is unwarranted. In some cases, measures that have been proven useful against one type of tumor may be inappropriately tried against another type. It is also important to realize that life-saving methods sometimes have permanent adverse effects. For these reasons, people with cancer should investigate their options thoroughly.
evidenCe-based TreaTMenT MeThods
The main types of standard treatment are surgery, radiation therapy, and chemotherapy. In some cases a combination is more effective than one method alone. Treatment may be done with the hope of curing the patient, or it may be done palliatively, with the hope of relieving discomfort or prolonging life. Even when it cannot increase survival time, modern cancer treatment may greatly improve the quality of life for patients with advanced cancers. Surgery is the primary treatment method for most major forms of cancer, especially in their early stages. Cancer surgery chiefly involves removal of the tumor and nearby tissues that may contain cancer cells. In some cases where the cancer has not spread, no further treatment is needed. Radiation therapy attacks cancers with ionizing radiation that is administered either externally with a machine or internally by inserting radioactive material into a body cavity or organ. Rapidly dividing cancer cells are particularly sensitive to radiation damage, but normal cells are also vulnerable. Radiation therapy thus involves a balance between destroying the cancer cells and the risk of side effects from damage to normal cells. Chemotherapy (treatment with anticancer drugs) has become increasingly effective. Because these drugs circulate to all parts of the body, they can attack cancer cells that have spread to distant organs. More than 100
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drugs have been FDA-approved for fighting cancer, and many others are being tested experimentally. Curative dosages usually have severe side effects. Lesser doses may be appropriate for palliation. However, former NCI Director Vincent DeVita warned that giving lesser dos- ages to potentially curable patients is “throwing away the cure rate.”17
Some techniques are used to enhance the effective- ness of current methods. Photodynamic therapy (PDT) uses special drugs along with light to kill cancer cells. Localized hyperthermia uses heat to kill cancer cells or make other treatments more effective. Marrow trans- plants are used to repopulate the patient’s blood cells after chemotherapy. Other therapies use the body’s im- mune system to fight cancer or to lessen the side effects of other treatments. These modalities include interferons, interleukins, colony-stimulating factors, monoclonal antibodies, vaccines, gene therapy, and nonspecific im- munomodulating agents.18 Some are “targeted therapies” that use substances to precisely identify and attack cancer cells. Anti-angiogenesis therapy uses substances that interfere with tumor blood supply. Patients for whom no established treatment is available may be eligible to enter a clinical trial of a new approach.19 Information about clinical trials can be obtained from one’s physician or the NCI Cancer Information Service Web site.20 Trials are conducted by cancer specialists throughout the United States. Scientific treatment facilities maintain a tumor reg- istry in which the details of cases treated at the facility are recorded, with follow-up queries sent annually to patients and/or their doctors. Data of this type are im- portant in assessing the results of treatment.
dieT and CanCer prevenTion
The fact that people with similar hereditary background living in different parts of the world can have different cancer patterns suggests that environmental causes play an important role, but the data are complex and difficult to interpret. Dietary factors may play a role in the development of certain cancers, but the proportion related to diet is not known. This section considers whether diet and dietary supplements can help prevent cancer. Whether any such approaches can treat cancer is discussed later in this chapter. The idea that dietary strategies might help prevent certain cancers first came to public attention in 1982 when the National Academy of Sciences (NAS)21 issued “interim guidelines” that included increased intake of foods rich in antioxidant nutrients and fiber. The ACS
issued similar guidelines but has modified them in light of subsequent research. Its current version22 advises:
• Eat a variety of healthful foods, with an emphasis on plant sources. Include 5 or more servings of a variety of veg- etables and fruits each day.
• Choose whole grains in preference to processed (refined) grains and sugars.
• Limit consumption of red meats, especially those high in fat and processed meat products.
• Choose foods that help maintain a healthful weight. Bal- ance caloric intake with physical activity. Lose weight if currently overweight or obese.
• Adopt an active lifestyle. Adults should engage in at least moderate activity for 30 minutes or more on 5 or more days of the week. Children and adolescents should engage in at least 60 minutes per day of moderate-to-vigorous physical activity at least 5 days per week.
• If you drink alcoholic beverages, limit consumption.
No scientific data indicate what proportion of cancers may be prevented by following such advice. However, it is unlikely to cause harm and may provide additional benefit such as lowering the incidence of cardiovascular disease and Type II diabetes. In 2007, the Cochrane Collaboration Colorectal Cancer Group23 concluded that calcium supplements may help prevent precancerous intestinal polyps, but no clinical trial has directly demonstrated an effect on the development of colorectal cancer.
Questionable Anticancer Supplements The health-food industry is usually quick to exploit new scientific information to its advantage. The 1982 NAS report on diet, nutrition, and cancer specified that since it was not known which dietary factors, if any, might be helpful, supplementation with individual nutrients was not advisable. A few months after the report was issued, however, several products containing dehydrated veg- etables and various nutrients were marketed as though the report had supported their use for cancer prevention. Government actions stopped some of these promotions, but others have taken their place. In recent years, un- substantiated cancer-prevention claims have been used to market “antioxidant” supplements (see Chapter 11). Fiber-containing pills have been marketed with sug- gestions that they can help prevent certain cancers. How- ever, this idea has no scientific support. Kritchevsky24 has noted that dietary fibers have value beyond their possible role in preventing colon cancer. He emphasized that “a high-fiber diet is not merely a low-fiber diet with fiber added. . . . All components of diets containing fiber- rich foods are important.”
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figure 16-1. Message from a comic book designed to promote Laetrile and undermine public trust in conventional methods of cancer treatment. Condemning accepted methods is a standard practice in medical quackery.
Actually, no link has been established between di- etary fiber intake and colon cancer. In 1999 researchers reported that their 16-year prospective study of 88,757 women found no significant relationship between fi- ber intake and the occurrence of precancerous polyps (colorectal adenomas).25 In 2001, the Cochrane Collabo- ration Colorectal Cancer Group26 reviewed five clinical trials and concluded that increasing fiber in a Western diet for two to four years did not lower the risk of bowel cancer.
Green Tea Green tea has been widely promoted as effective in preventing stomach cancer. However, in 2001, the New England Journal of Medicine27 published a large study that found no supporting evidence. The study involved more than 26,000 Japanese men and women who were followed-up over a 9-year period. No relationship was found between the number of cups consumed and the incidence of stomach cancer. An accompanying editorial explained why previous data suggesting that green tea might have a protective effect might be wrong.28
susCepTibiliTY To CanCer QuaCKerY
Cancer is a major field of exploitation of unproven and fraudulent treatments. People use questionable methods mainly because of fears that cancers are incurable and costly to treat, that treatment might be uncomfortable and mutilating, and that they will be socially stigma- tized. If their doctors seem discouraged or say that they can offer only palliative care, patients often lose hope and feel abandoned. Proponents of “sure cures” cater to these feelings by appearing optimistic and caring while
they promote false hopes. Figure 16-1 is an example of literature designed to undermine public trust in proven cancer treatment. Figure 16-2 shows an old ad for a product “guaranteed” to cure any cancer. People’s capacity to be fooled should not be underes- timated. During the 1940s, William Koch, M.D., Ph.D., acquired a large following of believers in a remedy that he claimed was 1.32 parts glyoxylide per trillion parts water. More than 3000 assorted practitioners paid $25 per ampule and charged patients up to $300 per injection. A product analysis found only distilled water. Several factors can influence people to believe they have been helped by an unconventional method. Some patients who believe they have been cured of cancer never had it in the first place. Patients who use a question- able treatment along with proven treatment may credit the questionable method for any improvement. Even fatal forms of cancer can have some ups and downs in their course, so that the patient may feel better on some days than others. A period of well-being following use of an unorthodox method can be misinterpreted as “improvement” or even “cure.” (See the “Heads I Win, Tails You Lose” box.) Some patients with slow-growing cancers are misrepresented as cured. Doctors sometimes give too pessimistic a prognosis. A patient who tries a nonstandard treatment and lives longer than predicted by a doctor may credit the alleged remedy instead of realizing that the doctor’s prediction was too pessimistic. Dr. William Jarvis has noted:
Any facility that treats large numbers of cancer patients will encounter some whose survival is much longer than average but still within expected variations. But only the quacks use these people to lure other cancer patients to their facility.
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Dr. Malcolm Brigden,29 a Canadian cancer specialist, noted that nonstandard treatments are appealing because their methods are explained in common-sense terms that seem plausible and offer an opportunity to play an active role in fighting the disease: (a) cancer is a symptom, not a disease; (b) symptoms are caused by diet, stress, or environment; (c) proper fitness, nutrition, and mental at- titude allow biologic and mental defense against cancer; and (d) conventional therapy treats the symptoms rather than the disease and weakens the body’s reserves. Many “alternative” promoters encourage patients to blame themselves for becoming ill. Cassileth and colleagues30 at the University of Pennsylvania Cancer Center interviewed 304 cancer center inpatients and 356 patients under the care of unconventional practitioners elsewhere. Among those who used “alternative treat- ment,” many believed that their cancer could have been prevented through diet (32% of patients), stress reduction (33%), or environmental changes (26%) and therefore was reversible by the same means.
QuesTionable MeThods
Cancer quackery is as old as recorded history and almost certainly has existed since cancer was recognized as a disease. Thousands of worthless folk remedies, diets, drugs, devices, and procedures have been promoted for cancer management.
The ACS has defined questionable methods as “diagnostic tests or therapeutic modalities which are promoted for general use in cancer prevention, diagnosis, or treatment and which are, on the basis of careful review by scientists and/or clinicians, not deemed proven nor recommended for current use.”31 The ACS has published detailed critical reports on many questionable methods that have achieved notoriety. In recent years, however, it has softened its approach and issued mostly brief reports on “complementary and alternative methods.” The mere fact that something is unproven does not make it “questionable.” For science to advance, research- ers and clinicians must be free to try new approaches. Before any cancer treatment is accepted for general use by physicians, it must undergo rigorous scientific scrutiny. When evaluating an unproven method, experts
look for:
1. Complete examination of the clinical evidence offered by the proponent, including visits and examinations of treated patients, review of microscopic slides of biopsies, and viewings of x-ray films.
2. Reproducible analysis of laboratory tests on animals and/or tissue culture. No drug that has failed laboratory tests has ever been proven effective against human cancer.
Heads I Win, Tails You Lose Quacks capitalize on the natural healing powers of the body by taking credit whenever possible for improve- ment in a patient’s condition. An opposite tack—shift- ing blame—is used by many cancer quacks. If their treatment does not work, it is because radiation and/or chemotherapy have “knocked out the immune system.” Emil J Freireich, M.D., of the M.D. Anderson Hospital and Tumor Institute in Houston, Texas, has combined these ploys into a tongue-in-cheek plan for becoming a successful quack:
1. Pick a “treatment” that is physically harmless. 2. Apply the “treatment” when the patient’s disease is
getting progressively worse. 3. If the patient’s condition improves or stabilizes,
take credit. Then stop the treatment or decrease the dosage.
4. If the patient’s condition worsens, say that the dos- age must be increased or that the treatment was stopped too soon.
5. If the patient dies, say that the treatment was ap- plied too late.
Personal Glimpse
figure 16-2. Ad from the 1920s. C.R. Chamlee claimed that a Pacific island shrub produced his “cures,” but chemical analysis revealed that “Chamlee’s Cancer Specific” contained only alcohol and water, with small amounts of iron, strychnine, and saccharin. Federal authorities stopped his mail-order business, but for several more years he was able to dispense the product from his offices in Chicago and Los Angeles.
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Historical Perspective
Some Notes on Cancer Quackery Andrew C. Ivy, a widely known medical researcher who was vice-president of the University of Illinois. Durovic solicited Ivy’s help in testing a compound he called krebiozen, which he claimed was produced by injecting Argentinean horses with Actinomyces bovis, the microorganism that causes a disease called “lumpy jaw” in cattle. From the blood of these horses, Durovic said he extracted a “whitish powder” that he mixed with mineral oil. Ivy, who had served as executive director of the National Cancer Advisory Council, was impressed by the results ob- tained on a number of cancer patients and publicly supported krebiozen. However, in 1952 six prominent physicians re- viewed 500 of Ivy’s cases and concluded there was no accept- able evidence that krebiozen had benefited any of them. Dr. Ivy refused to accept these conclusions, and the controversy continued. In 1961 the NCI received a small amount of kre- biozen along with clinical data from 4200 patients, of which 504 cases were submitted for review. Twenty-four scientists then conducted a study and concluded that krebiozen was ineffective against cancer. In 1963 the FDA identified krebiozen powder as creatine, an amino-acid constituent of meat and normally found in the body. The FDA reported that krebiozen sold before 1960 consisted of mineral oil only, whereas after 1963 it contained creatine monohydrate, which would not dissolve in mineral oil. Meanwhile, the Cancer Advisory Council of the Califor- nia State Department of Public Health had concluded that krebiozen had no value in the treatment of cancer. In 1964 Dr. Durovic, his brother Marko, Dr. Ivy, and Dr. William P. Phillips were indicted on 49 counts of violating the Food, Drug and Cosmetic Act, mail fraud, mislabeling, mak- ing false statements to the government, and conspiracy. All were acquitted in 1966. The verdict did not alter the fact that krebiozen has no anticancer effect in humans, but loss of this case was very discouraging to the officials who had worked diligently to try to protect the public. Laetrile is the trade name for a synthetic relative of amygdalin, a chemical in the kernels of apricot pits, apple seeds, bitter almonds, and some other stone fruits and nuts. Many promoters have called it “vitamin B17” and have falsely claimed that cancer is a vitamin deficiency disease that Laetrile can cure. Proponents claim that Laetrile kills tumor cells se- lectively while leaving normal cells alone. Although Laetrile
During each decade between 1940 and 2000, at least one dubious cancer treatment attracted a large following and become a national issue. The most prominent have been Koch’s glyoxylide in the 1940s, the Hoxsey treatment in the 1950s, krebiozen in the 1960s, Laetrile in the 1970s, immuno- augmentative therapy in the 1980s, and shark cartilage during the 1990s. The Hoxsey method, developed by naturopath Harry M. Hoxsey in the early 1920s, involved three elements: a liquid for internal use, a corrosive external compound, and supportive treatment. The internal substance contained potassium iodide (an expectorant), licorice, red clover, burdock root, stillingia root, berberis root, poke root, cascara (an herbal laxative), prickly ash bark, and buckthorn bark. The external substance was a yellow powder, a red paste, or a clear solution containing one or more chemicals capable of destroying cancerous tissues on contact. Unfortunately, they destroy healthy tissue as well. The supportive treatment included preparations containing iron, urinary antiseptics, vitamins, laxatives, and antacids. Three times during the late 1920s, Hoxsey was convicted of practicing medicine without a license. In 1930 he was per- manently enjoined for violating the Iowa Medical Practice Act. In 1936, after unsuccessful attempts to practice in other states, he moved to Dallas, Texas, where he maintained a thriving practice until vigorous FDA action drove him to Mexico. In various trials against Hoxsey, the government presented scientific evidence that his “cured” patients fell into three categories: (1) those who never had cancer, (2) those who had been cured before going to his office, and (3) those who still had their disease or died under the Hoxsey treatment. Hoxsey, who based his defense on testimonials from 22 patients, won the case. However, the FDA, which suspected that the judge had once been a Hoxsey patient, appealed the case and had the decision reversed. In 1963, after Hoxsey’s appeal to the Supreme Court failed, he moved his clinic to Tijuana. He died in 1973, but the clinic was operated for many more years by a nurse who had worked with him. The krebiozen story illustrates how a reputable scientist may become misdirected. In 1949 Dr. Steven Durovic, a physi- cian from Buenos Aires, came to the United States to work with scientists at Northwestern University on a “whitish powder” called kositerin, which he thought was useful in treating hy- pertension. The substance proved useless, but Durovic met Dr.
3. Evidence of effectiveness in trials on a sufficient number of patients with biopsy-proven cancers. This must include valid statistical comparison of treated and untreated individuals.
4. Evaluation of autopsy data of treated patients who died. 5. Cooperation with other investigating organizations such
as the NCI, the FDA, and the Memorial Sloan-Kettering Cancer Center.
Questionable methods are broadly classifiable as corrosive agents, plant products, diets and “dietary supplements,” drugs, correction of “imbalances,” bio- logic methods, devices, psychologic approaches, and worthless diagnostic tests. Many promoters combine methods to make themselves more marketable. The next few pages provide examples of these types. Although
Chapter Sixteen Cancer 337
some are no longer marketed, their histories still illustrate the nature and variety of cancer quackery. Corrosive agents. Many salves, poultices, and plas- ters have been applied directly to tumors with the hope of burning them away. Turpentine is an old favorite. It has been claimed that some corrosive agents “draw out” the cancer. The Hoxsey method (see Historical Perspec- tive box) included a product of this type. In recent years
scientists have found chemicals that can destroy some superficial skin cancers. Except for these, however, cor- rosive agents are worthless against cancer. Plant products. Most folk remedies fall into the plant category. Brews, such as a tea from red clover, are drunk or used to wash external cancers. Mucorhicin, said to be produced by cultivating mold on a nutrient, was composed of yeast, salt, whole wheat, and sterile water.
Historical Perspective
Some Notes on Cancer Quackery—Cont’d. obtained from several patients and were able to culture the virus from one specimen—suggesting that blood infected with the virus had been used to prepare IAT treatment materials.39 Burton died in 1993, but his former medical director continued to operate the clinic (renamed ITL Cancer Clinic). The Personal Glimpse box on page 342 describes how trick- ery may have been used to make patients think they had been helped by IAT. Powdered shark cartilage is purported to contain a pro- tein that inhibits the growth of new blood vessels needed for cancer to spread. Although a modest effect has been observed in laboratory experiments, it has not been demonstrated that feeding shark cartilage to cancer patients significantly inhibits blood-vessel formation. Even if direct applications were effec- tive, oral administration would not work because the protein would be digested rather than absorbed intact into the body. Nevertheless, in 1993, “60 Minutes” promoted the claims of biochemist/entrepreneur I. William Lane, Ph.D., co-author of Sharks Don’t Get Cancer. The program highlighted a Cuban study of 29 “terminal” cancer patients who received shark- cartilage preparations. The program showed several doing exercise and reported that most felt better several weeks after starting treatment. The fact that “feeling better” does not indi- cate whether a cancer treatment is effective was not mentioned. Nor was it mentioned that sharks do get cancer, even of their cartilage. National Cancer Institute officials who reviewed the Cuban data called them “incomplete and unimpressive.”40 Figure 16-3 shows how a major health-food–industry book distributor mentioned the “60 Minutes” broadcast in an ad plugging Lane’s book. In 2000, Lane Labs-USA, Inc., Andrew J. Lane, Cartilage Consultants, Inc., and I. William Lane agreed to settle FTC charges that they had made unsubstantiated claims that their shark cartilage product (BeneFin) and another product were effective against cancer. The settlement required Lane Labs to pay $550,000 to the FTC and an additional $450,000 to subsidize a clinical trial of shark cartilage co-sponsored by the National Cancer Institute.41 That trial, which was reported in 2005, found no benefit.42
Today, due largely to the Internet, cancer scams are pitched to huge audiences at minimal expense. Government agencies are very active, but the number of scammers greatly exceeds the government’s capacity.
has been promoted as safe and effective, clinical evidence indicates that it is neither.32–35 When subjected to enzymatic breakdown in the body, it forms glucose, benzaldehyde, and hydrogen cyanide. Some patients treated with Laetrile have suffered nausea, vomiting, headache, and dizziness, and a few have died from cyanide poisoning. Tests of Laetrile in at least 20 animal tumor models have found no benefit either alone or together with other substances. Studies of human case reports have also been uniformly negative. In 1975 a class-action suit was filed to stop the FDA from blocking the distribution of Laetrile. Early in the case, a federal district court judge ruled that cancer patients could import a 6-month supply of Laetrile for personal use if they could obtain a physician’s affidavit that they were “terminal.” In 1979 the U.S. Supreme Court ruled that it is not possible to be certain who is terminal and that even if it were, both termi- nally ill patients and the general public deserve protection from fraudulent cures. In 1987, after further appeals were denied, the affidavit system was terminated. Today few sources of Laetrile are available within the United States, but it still is utilized at Mexican clinics. In 2011, a Cochrane review concluded that there is no reliable evidence for the alleged effects of Laetrile or amygdalin for curative effects in cancer patients.36
Zoologist Lawrence Burton claimed that his immuno- augmentative therapy (IAT) could control all forms of cancer by restoring natural immune defenses. He claimed to ac- complish this by injecting blood serum proteins isolated with processes he had patented. However, experts concluded that the substances he claimed to use could not be produced by these procedures and do not exist in the human body.37
In 1979 Burton received an enormous boost when CBS- TV’s “60 Minutes” gave him favorable publicity. A prominent physician stated that one of his patients treated by Burton appeared to have miraculously recovered. The patient died within 2 weeks after the program was shown, but “60 Minutes” never informed viewers of this fact. Burton’s literature included a booklet summarizing the experiences of 35 IAT patients and their status as of February 1988. However, Dr. Wallace Sampson, a cancer specialist who examined the data, concluded that the sampling of cases was not meaningful and that 30 of the patients had standard or near-standard treatment prior to IAT. 38 In 1985 public health officials found antibodies to the AIDS virus in vials of serum
Part Four Personal Health Concerns338
Essiac is an herbal tea that was prescribed and promoted for about 50 years by Rene M. Caisse, a Canadian nurse who died in 1978. Several reports state that the formula contains burdock, Indian rhubarb, sorrel, and slippery elm, but there may be additional ingredients. Animal tests using samples of Essiac have shown no antitumor activity,43 nor did a review of data on 86 patients per- formed by the Canadian federal health department during the early 1980s. Hulda Clark, an unlicensed naturopath who died of multiple myeloma (a bone marrow cancer) in 2009, claimed that (a) all cancers, AIDS, and many other diseases are caused by “parasites, toxins, and pollut- ants”; (b) cancers can be detected with a blood test for ortho-phospho-tyrosine and a device that identifies diseased organs and toxic substances; (c) cancers can be cured by killing the parasites and ridding the body of environmental chemicals; (d) black walnut hulls,
wormwood, and common cloves can rid the body of over 100 types of parasites; and (e) the amino acids ornithine and arginine improve this recipe. Her book Cure for All Cancers contains 103 case histories of her supposed cures. However, judging from her descriptions, (a) most did not have cancer and (b) of those who did, most had received standard medical treatment or their tumors were in early stages.44
Pau d’arco tea, sold through health-food stores and by mail, is said to be an ancient Incan remedy prepared from the inner bark of various species of Tabebuia, an evergreen tree native to the West Indies and Central and South America. However, stories about its origins contain a variety of geographic and botanical errors. Proponents claim that pau d’arco tea is effective against cancer and many other ailments. Tabebuia woods con- tain lapachol, a chemical that has been shown to have antitumor activity in a few studies on animals. However, human studies have found that as soon as significant blood levels were attained, undesirable effects were severe enough to require that the drug be stopped.45 Diets and “dietary supplements.” Many dietary ap- proaches have been recommended as cancer treatments, including fasting, megadoses of nutrients, consumption of raw foods, and various complicated dietary regimens. The grape cure promoted by Joanna Brandt involves eating large quantities of grapes for 1 or 2 weeks, then adding sour milk, raw vegetables, other fruits, nuts, honey, and olive oil. The macrobiotic diet, discussed in Chapter 11, is a semivegetarian approach claimed to cure cancer and many other health problems.46 Anthony Sattilaro, M.D., who wrote Recalled by Life, told how he underwent standard treatment for prostate cancer but claimed that macrobiotic eating placed him in “permanent remission.” However, he died of his disease a few years after the book was published. The Gerson diet is claimed to accomplish “detoxifi- cation” with frequent coffee enemas and a low-sodium diet that includes more than 1 gallon a day of juices made from fruits, vegetables, and raw calf’s liver. Ger- son protocols have also included liver-extract injections, ozone enemas, “live cell therapy,” thyroid tablets, royal jelly capsules, linseed oil, castor oil enemas, clay packs, Laetrile, and vaccines made from influenza virus and killed Staphylococcus aureus bacteria. This approach was developed by Dr. Max Gerson, a German-born physician who emigrated to the United States in 1936. The treatment, available at clinics in Mexico and Hun- gary, is still actively promoted by Gerson’s daughter Charlotte through lectures, talk-show appearances,
figure 16-3. Within weeks of the “60 Minutes” broadcast, many manufacturers began marketing shark-cartilage products. The false claims in this ad (and the book) would be illegal in marketing products, but freedom of the press protected the authors, and the advertiser merely described what the book said.
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and publications. Although Ms. Gerson claims high cure rates, these claims are not based on systematic monitoring of patients after they leave the clinic.47 Three naturopaths who visited the Gerson Clinic in 1983 were able to track 18 patients over a 5-year period (or until death) through annual letters or phone calls. At the 5-year mark, only one was still alive (but not cancer- free); the rest had succumbed to their cancer.48 Green has concluded that the Gerson rationale is unfounded because (a) the “poisons” Gerson claimed to be present in processed foods have never been identified, (b) frequent coffee enemas have never been shown to mobilize and remove poisons from the liver and intestines of cancer patients, (c) there is no evidence that any such poisons are related to the onset of cancer, and (d) there is no evidence that a “healing” inflammatory reaction exists that can seek out and kill cancer cells.49 The American Cancer Society50 advises that although dietary measures may help prevent certain cancers, there is no scientific evidence that any nutrition-related regi- men is appropriate as a primary treatment for cancer. Brooks51 has noted:
No one will argue with the idea that eating a healthy, balanced diet is important for general health. However, there is no logical reason to believe that dietary supplements or special diets can improve immune system function in people who are not malnourished. Nor is there any evidence that dietary supplements can “boost” the immune system to produce cancer regression.
Drugs. Iscador, an extract of mistletoe, was pro- posed for the treatment of cancer in 1920 by Rudolf Steiner, a Swiss physician who espoused occult beliefs. Steiner founded the Society for Cancer Research to promote mistletoe extracts and occult practices he called anthroposophical medicine. A 1962 report by the society claimed that the time of picking the plants was important because they react to the influences of the sun, moon, and planets. Various mistletoe juice preparations have been studied with the hope of finding an effective anticancer agent. However, in 1984, the expert working group of the Swiss Society for Oncology concluded that there was no evidence that Iscador was effective against human cancers.52 Since that time, two well-designed clinical trials have found no benefit.53,54
During the past decade, oxygen-rich substances (germanium sesquioxide, hydrogen peroxide, superoxide dismutase, and ozone gas) have been utilized by many promoters of questionable cancer regimens. Their use is based on the erroneous notion that cancer is caused by oxygen deficiency and can be cured by exposing cancer cells to more oxygen than they can tolerate. Although
these compounds have been the subject of legitimate research, there is little or no evidence that they are effective for the treatment of any serious disease, and each has demonstrated potential for harm.55,56 Germa- nium products, for example, have caused irreversible kidney damage and death. The FDA has banned their importation and seized products from several American manufacturers. CanCell, originally called Entelev, is a liquid claimed to cure cancer by “lowering the voltage of the cell structure by about 20%,” causing cancer cells to be “digested” and replaced with normal cells. Accompa- nying directions have warned that bottles of CanCell should not be allowed to touch each other or be placed near any electrical appliance or outlet. CanCell has also been promoted for the treatment of AIDS, amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer’s disease, “extreme cases of emphysema and diabetes,” and several other diseases. In 1989 the FDA reported that CanCell contained inositol, nitric acid, sodium sulfite, potassium hydroxide, sulfuric acid, and catechol.57 Subsequently, its promoters claimed to be modifying the formulation to make it more effective. They have also claimed that CanCell cannot be analyzed because it varies with atmospheric vibrations and keeps changing its energy. Laboratory tests conducted between 1978 and 1991 by the NCI found no evidence that CanCell was effective against cancer. The FDA has obtained an injunction forbidding its distribution to patients.58
In the mid-1970s hydrazine sulfate was proposed for treating the progressive weight loss and body deteriora- tion characteristic of advanced cancer. Based on animal data and preliminary human studies, it was also claimed to cause tumor regression and subjective improvement in patients. However, three trials sponsored by the NCI found that hydrazine sulfate was no better than a pla- cebo.59 In one study, nerve damage occurred more often and the quality of life was significantly worse in the hydrazine sulfate group. Cases have also been reported of liver and kidney failure and encephalopathy following hydrazine sulfate administration. Beginning in 1995, Kathy Keeton, wife of Penthouse magazine publisher Bob Guccione, achieved widespread publicity with claims that hydrazine sulfate had enabled her to recover from stage IV metastatic cancer after doc- tors gave her only 6 weeks to live. However, she died of her disease in 1997. The 5-year survival rate with such a cancer is 12% to 20%. A 2-year survival is certainly not impressive.60
“Antineoplastons” is the name given by Stanislaw R. Burzynski, M.D., to substances that he claims can
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“normalize” cancer cells. He has published many pa- pers in which he claims that antineoplastons extracted from urine or synthesized in his laboratory have proven effective against cancer in laboratory experiments. He also claims to have helped many people with cancer get well. In 1982 two Canadian experts visited Burzynski’s clinic and asked for information on the patients he felt best demonstrated that his treatment was effective. After reviewing the status of about a dozen cases, they concluded that all who were still alive had either had slowly growing tumors or had received effective treat- ment before seeing Burzynski. In a report to the Canadian Ministry of Health they stated:
We were surprised that Dr. Burzynski would show us such questionable cases. We were left with the impression that either he knows very little about cancer and the response of different tumors to radiation and hormonal measures, or else he thinks that we are very stupid, and he has tried to hoodwink us.61
In 1988 talk-show host Sally Jesse Raphael fea- tured four patients of Burzynski whom she described as “miracles.” The patients stated that Burzynski had cured them when conventional methods had failed. In 1992 the television program “Inside Edition” reported that two of the four patients had died and a third was having a recurrence of her cancer. (The fourth patient had bladder cancer, which has a good prognosis.) The widow of one of Raphael’s guests stated that her husband and five others from the same city had sought treatment after learning about Burzynski from a television broad- cast—and that all had died of their disease. Saul Green, Ph.D.,62 a biochemist who worked for many years at Memorial Sloan-Kettering Hospital investigating the mechanisms and treatment of cancer, found no evidence that any of the substances Burzynski calls “antineoplastons” had been proven to “normal- ize” tumor cells. In 1998, the Texas Attorney General secured a consent agreement stating that Burzynski (a) cannot distribute unapproved drugs in Texas; (b) can distribute “antineoplastons” only to patients enrolled in FDA-approved clinical trials, unless the FDA approves his drugs for sale; (c) cannot advertise “antineoplastons” for the treatment of cancer; and (d) must include a dis- claimer on his Web site, promotional material, and ads that “antineoplastons” have not been established as safe and effective. The agreement also called for Burzynski to pay $50,000 to reimburse the State of Texas for the cost of its investigations.63 The Cancer Letter subsequently noted that although Burzynski set up many “clinical trials,” they do not conform to usual standards.64
714X is a chemical solution produced in Quebec by Gaston Naessens, who also operates the International Academy of Somatidian Orthobiology. In 1956, in con- nection with an alleged cancer remedy called GN-24, Naessens was convicted of illegal medical practice and ordered by a French court to pay the maximum appli- cable fine. He was prosecuted again in 1964 after another alleged cancer remedy he administered in Corsica was proven not to work. Naessens claims that 714X can “fluidify the lymph” and “direct nitrogen into the cancerous cells in order to stop their toxic secretions which block the organism’s de- fense system.” The Canadian Health Protection Branch has found that 714X contains a mixture of camphor, ammonium chloride and nitrate, sodium chloride, ethyl alcohol, and water. The agency has received no scientific data to support claims that 714X is effective. However, as a result of a court ruling, it permits physicians to ap- ply for special access to prescribe it on a case-by-case basis.65 PC-SPES was said to be a centuries-old Chinese remedy that could fight prostate cancer by boosting the immune system. It showed some evidence of effective- ness but turned out to have been spiked with an estrogen- containing drug that is known to be effective in some cases of prostate cancer.66 After the truth was disclosed, the sellers withdrew it from the marketplace, entered “no contest” pleas, and signed consent agreements to settle criminal and civil charges. Correction of “imbalances.” Revici Cancer Control (also called lipid therapy) was based on the belief that cancer is caused by an imbalance between constructive (anabolic) and destructive (catabolic) body processes. This approach was developed by Emmanuel Revici, M.D. (1896–1998), who practiced in New York City. His formulations, which varied from visit to visit, were based on measurements of the specific gravity, pH (acid- ity), and surface tension of single samples of the patient’s urine. Revici also claimed success against AIDS. Revici’s method of urinary interpretation was not valid. The specific gravity of urine reflects the concentra- tion of dissolved substances and varies with the amount of fluid a person consumes. The acidity depends mainly on diet and varies considerably throughout the day. Thus, even when these values are useful for a metabolic evalu- ation, information from a single urine sample would be meaningless. The surface tension of urine has no medically recognized diagnostic value.67 In 1993, after a lengthy battle, New York State’s licensing authorities revoked Revici’s medical license.
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Today, the most common approach to alleged “im- balances” involves claims that cancer thrives when the blood is acidic and can be cured by using dietary mea- sures and supplements that make it alkaline. Proponents suggest testing the acidity (pH) of saliva and acting accordingly. There is no scientific evidence or reason to believe that blood pH is a factor in cancer growth. Moreover, the body’s homeostatic mechanisms keep blood pH within a narrow range that is not influenced by the dietary strategies advocated for curing cancer.68
Biologic methods. “Vaccines” and similar products have been prepared from various substances including pooled cancers, the patient’s own blood and/or urine, animal blood and/or urine, and cultures of germs. Vir- ginia Livingston, M.D., who died in 1990, postulated that cancer is caused by a bacterium that invades the body when resistance is low.69 To combat the cancer, she allegedly strengthened the body’s immune system with various vaccines (including one made from bacteria taken from the patient’s urine); a vegetarian diet that excludes chicken, eggs, and sugar; vitamin and mineral supplements; visualization; and stress reduction. She claimed to have a very high recovery rate but published no clinical data to support this. Scientists who attempted to isolate the organism she postulated found that it was a common skin bacterium. Researchers at the University of Pennsylvania Cancer Center compared 78 patients with advanced cancer treated at the center with 78 similar patients who had been given various vaccines, a vegetarian diet, and coffee enemas at the Livingston- Wheeler Clinic. The study found no difference between average survival time of the two groups. However, the Livingston-Wheeler patients reported more problems with appetite and pain.70
Fresh cell therapy, also called live cell therapy and cellular therapy, involves injections of fresh embryonic animal cells taken from the organ or tissue that corre- sponds to the unhealthy organ or tissue in the patient. Proponents claim that the recipient’s body automatically transports the injected cells to the target organ where they repair and rejuvenate the ailing cells. The originator of this approach was Paul Niehans, a Swiss physician who died in 1971. The ACS71 states that fresh cell therapy has no proven benefit and has caused serious side effects (infections and immunologic reactions to the injected protein) and death. Hariton Alivizatos, a Greek physician who died in 1991, claimed to have developed a blood test that can determine the type, location, and severity of any can- cer. He also claimed to have developed a “serum” that enabled the patient’s immune system to destroy cancer
cells and helped the body rejuvenate parts destroyed by cancer.72 Knowledgeable observers believe the princi- pal ingredient of the so-called Greek Cancer Cure was niacin. Insulin potentiation therapy (IPT) involves giving substandard doses of chemotherapy drugs after insulin is administered intravenously. Proponents claim that the insulin increases the effect of medications so that lower doses can be used. They also suggest that the insulin somehow makes cells more permeable so that certain drugs enter more easily. However, there is no logical reason to believe this is true, and no scientific evidence shows that IPT is safe or effective as a cancer treatment.73
Devices. Many gadgets have been falsely claimed to diagnose and/or treat cancer.74 One of the most notorious was the Orgone Energy Accumulator, which was claimed by Wilhelm Reich, M.D., to treat disease by absorbing “blue bions” or “Cosmic Orgone Energy.” In 1956 Reich and an associate were sentenced to prison for violating an earlier injunction against distributing his devices. Devices used or marketed by others have included Hulda Clark’s “zappers” and other equipment that pass low-voltage electrical current through tumors or the body; low-level magnetic devices; “electroacupuncture” devices purported to measure the electrical resistance of so-called “acupuncture points” for diagnosis and prescription; colonic irrigation machines claimed to “detoxify the system”; electrical devices said to “charge” blood samples that are taken from and later returned to patients; negative ion generators claimed to have an effect against tumors; radionics devices (such as Rife machines) claimed to diagnose and cure cancer by ana- lyzing and emitting radio waves at the correct frequen- cies; magnets claimed to cure cancers by “improving circulation” or by intracellular effects; crystals alleged to have curative powers; pendulums used to diagnose or locate tumors in a manner similar to that of divining rods; pyramidal objects alleged to focus occult energies for healing purposes; and a brassiere claimed to prevent breast cancer and either increase or decrease the size of the bosom. Neither quacks nor their victims seem to have any limit to the scope of their imagination. Psychologic approaches. Various psychologic methods are promoted to cancer patients as cures or as adjuncts to other treatment. The techniques include imagery, visualization, meditation, progressive muscle relaxation, and various forms of psychotherapy. These techniques may reduce stress, alleviate depression, help control pain, and enhance patients’ feelings of mastery and control. Individual and group support can have a positive impact on quality of life and overall attitude.
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A positive attitude may increase a patient’s chance of surviving cancer by increasing compliance with proven treatment. However, it has not been demonstrated that emotions directly influence the course of the disease. Bernie Siegel, M.D., author of Love, Medicine & Miracles and Peace, Love & Healing, is a surgeon who claims that “happy people generally don’t get sick” and that “one’s attitude toward oneself is the single most important factor in healing or staying well.” He also states that “a vigorous immune system can overcome cancer if it is not interfered with, and emotional growth toward greater self-acceptance and fulfillment helps keep the immune system strong.” No scientific study supports these claims. Siegel coauthored a report of a 10-year study that found that 34 breast cancer patients participat- ing in his Exceptional Cancer Patients program lived no longer after diagnosis than comparable nonparticipants.76 The program consisted of peer support, family therapy, individual counseling, and the use of positive imagery. O. Carl Simonton, M.D., claims that cancers can be affected by relaxation and visualization techniques. He asserts that this approach can lessen fears and tension, strengthen the patient’s will to live, increase optimism, and alter the course of a malignancy by strengthening the immune system. However, he has not published the results of any well-designed study testing his ideas. He and his wife, Stephanie (a psychotherapist), taught
patients to imagine their cancer being destroyed by their white blood cells. However, there is no evidence that white cells actually attack cancer cells in this manner. Simonton’s book Getting Well Again included re- ports on patients who got better after using his methods. However, Friedlander77 analyzed five of the reports he thought might impress laypersons most and noted that two of the patients had undergone standard treatment, one had a slow-growing tumor, and one probably did not have cancer. The fifth patient’s tumor was treatable by standard means. Some suggest that Simonton’s program may have positive psychologic effects because it may help people relax and give them a feeling that they are doing some- thing positive. However, scientific studies have found no clear-cut relationship between emotions, personality factors, stresses, and cancer. Simonton has done some studies, but the American Cancer Society and others have questioned their design.78 Although his method is physically harmless, it may encourage some patients to abandon effective care. British researchers have reviewed 30 studies that examined whether psychologic factors can influence survival from cancer. Twenty-six investigated the as- sociation between coping styles and survival, and 11 investigated their effect on recurrence. The parameters evaluated included “fighting spirit,” “hopelessness/
Personal Glimpse
A Victim’s Experience In 1982 my father-in-law was diagnosed as having unresectable, incurable, widely disseminated cancer of the lung, and advised that essentially his condition was terminal. As could be expected, the family was distraught, and we began to grasp at straws and looking into alternative modes of treatment. . . . Some of the local press carried stories about . . . so-called immuno-augmentative therapy. . . . Soon thereafter he went to the Bahamas to get the treatment. His main symptom had been pain from the tumor. It had metastasized to the bones. When he went down there, he was told to go off pain medication and to begin the serum injections, and that . . . the serum injections, if they work and dissolve the tumor, will cause pain. So he went down there knowing he had a tumor growing in him and causing him pain, and through a pretty good ploy he came back convinced that the pain he was having was a cure. In addition, he was told the tumor was shrinking. The x-ray film they took was overexposed, which has the technical problem of making masses look smaller than they really are. Upon his return I encouraged him to go to Fox Army Hospital and have another chest x-ray made. Several radiolo- gists corroborated that they could see no evidence of any shrinkage in the tumor. I was then faced with the unpleasant task of telling my father-in-law for the second time he was dying. It was interesting that both he and his wife came back with total euphoria—that he was cured. They told everyone they saw he was cured. When they realized that they had been fooled, it was really a shock, and, of course one doesn’t usually go around telling people you have been fooled. He died approximately 2 months after he returned. In addition to the emotional turmoil and being away from the rest of the family for essentially half the remaining life he had, this cost them approximately $10,000, including travel and lodging, for this phony cancer cure. Carl Barnes, M.D.75
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helplessness,” “denial or avoidance,” “stoic acceptance or fatalism,” “anxious coping/anxious preoccupation,” “depressive coping,” and “active or problem-focused coping.” Noting that positive findings tended to be confined to studies that were small or poorly designed, the authors concluded:
There is little consistent evidence that psychological coping styles play an important part in survival from or recurrence of cancer. People with cancer should not feel pressured into adopting particular coping styles (including ‘positive think- ing’) to improve survival or reduce the risk of recurrence.79
Subsequent reviews of published reports have concluded that existing data do not support the claim that psychotherapy prolongs cancer survival and that a large-scale trial would be a poor investment of research funds because the claim is implausible.80,81 Worthless diagnostic tests. H.H. Beard, a biochem- ist, claimed that his Beard Anthrone Test could detect cancer in the body within 2 or 3 weeks after it started by measuring a sex hormone in the urine. He was indicted for mail fraud in 1967 and subsequently received a 6-month suspended prison sentence. William Kelley, D.D.S., a dentist who treated can- cer patients, used two tests. His Protein Metabolism Evaluation Index was based on the premise that cancer is a foreign protein. His Kelley Malignancy Index was claimed to be “the most accurate and extensive cancer detection system ever developed.”82 A booklet by Kelley claimed “at least 86% of all cancer conditions can be treated by diet alone” and that “cancer is nothing more than a pancreatic enzyme deficiency” caused by eating too much of the wrong kind of protein. “If people would not eat protein after 1:00 PM,” the booklet stated, “83% of cancer in the United States could be eliminated.” In 1970 Kelley was convicted of practicing medi- cine without a license after witnesses testified that he had diagnosed lung cancer on the basis of blood from a patient’s finger and prescribed dietary supplements, enzymes, and a diet as treatment. His dental license was subsequently suspended, but he continued to promote his methods until the mid-1980s. Treatment said to be similar is still provided today by Nicholas Gonzalez, M.D., of New York City, who claims to have analyzed Kelley’s records and drafted a book about his findings. The manuscript was never published, but experts who evaluated its chapter on 50 cases found no evidence of benefit. In 1994, after investigating six of Gonzalez’s cases, New York State licensing authorities concluded that (a) his “alternative protocol” did not entitle him to an al- ternative standard of care, (b) he had failed to correctly
interpret signs and symptoms of disease progression, (c) he had treated the patients incompetently, and (d) his record-keeping was inadequate. He was placed on probation for 3 years with stipulations that he undergo retraining and his work be supervised by the Office of Professional Conduct. In 1997 a jury in New York City awarded $2.5 million in actual damages and $150,000 in punitive damages to a former Gonzalez patient. The woman testi- fied that she had been diagnosed with an early stage of uterine cancer and underwent a hysterectomy. Instead of undergoing medically recommended radiation and chemotherapy, she consulted Gonzalez who discouraged her from following this advice. Gonzalez prescribed up to 150 dietary supplement pills a day plus frequent cof- fee enemas. Later he claimed that the cancer was cured even though it was progressing. It eventually damaged her spine and left her blind. An appeals court upheld the $2.5 million verdict but dismissed the punitive damage award. Despite these problems, the NIH’s National Center for Complementary and Alternative Medicine awarded a $1.4 million grant to Columbia University to study Gonzalez’s work. The study found no benefit.83
“Metabolic Therapy” “Metabolic therapy” is based on the idea that cancer and other chronic illnesses result from a disturbance of the body’s ability to protect itself. The components of metabolic therapy vary from practitioner to practi- tioner. No controlled study has shown that any of its components has any value against cancer or any other chronic disease. However, many people find its concepts appealing because they do not seem far removed from scientific medicine’s concerns with diet, lifestyle, and the relationship between emotions and bodily responses. Metabolic therapy’s most visible proponent was Harold Manner, Ph.D., a former biology professor who left his academic position to market his ideas. Manner defined metabolic therapy as “the use of natural food products and vitamins to prevent and treat disease by building a strong immune system.” He theorized that environmental chemicals cause many primitive cells to become cancerous. He said that when the immune system is functioning normally, the cancer cells are destroyed. But if it is weakened by poor nutrition, environmental pollutants, or debilitating stress, cancer cells are unin- hibited and multiply rapidly. Therefore, cancer can be treated by revitalizing the body’s immune system with diet, dietary supplements, and “detoxification.” During 1988 Manner’s Tijuana clinic charged $7500 for its 21-day program of vegetable juices, “natural foods”; intravenous Laetrile; coffee enemas;
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inspirational messages; and large amounts of vitamins, minerals, enzymes, glandular extracts, and other prod- ucts. Although Manner claimed a very high success rates, there is no evidence that he kept track of how patients fared once they left his clinic. That same year, a reporter who attended Manner’s “Advanced Course in Metabolic Therapy” by pretending to be a chiropractor observed that attendees were instructed to use standard code numbers on insurance claims so they could be paid for their services. The reporter also noted that those who joined the Manner Metabolic Foundation were promised a $200 “referral fee” for each patient they referred to Manner’s Mexican clinic.84 Manner died in 1988, but the clinic continued to operate for several years.
proMoTion of QuesTionable MeThods
Cancer treatment methods that lack a scientific basis are readily available and aggressively promoted. The promoters run the gamut from ignorant individuals to highly educated scientists with advanced degrees. Some even hold medical degrees. Such individuals typically (a) discount biopsy verification, (b) fail to keep adequate records, (c) spread claims through the media rather than through scientifically acceptable channels subject to peer review, (d) tend to be isolated from established scientific facilities or associates, and (e) claim persecution by the medical establishment. Many promoters claim that cancer is the result of adverse environmental influences, excess protein intake, self-pollution by bad habits, and incorrect spiritual atti- tudes. Their “corrective” methods include meatless diets; “cleansing” of the body by special diets, enemas, and antioxidants; megadoses of vitamins and trace minerals; and various spiritual approaches. Cassileth85 has noted:
Most [such programs] are within the control of the patient, who can choose which part . . . to accept, which part to cheat on, and which part to amplify. There is no FDA regulation of most of these programs since the FDA has no jurisdiction over dietary theories, personal vitamin consumption or spiritual improvement. What’s more, no action can be taken against the proponents for claiming that orthodox approaches are unnatural and bad.
Dubious Information Sources Cancer patients can obtain information about question- able methods in many ways: 1. Personal contacts. Referrals may be made by friends, neighbors, or other people who know someone supposedly helped by nonstandard treatment. In some communities, traffic in questionable methods is so well
organized that proponents infiltrate hospitals to tout their methods during “chance meetings” in waiting rooms. 2. Magazines and books. Articles promoting ques- tionable treatments appear frequently in magazines that cater to the health-food industry and sporadically in other magazines. The titles of books that promote dubi- ous cancer treatments typically contain buzzwords such as alternative, answer (rhymes with cancer), cleanse, curing, detoxify, foods, healing, herbal, immune, inte- grative, natural, nontoxic, nontraditional, nutritional, suppression, and/or traditional. Such books are skillfully written and can cause the average reader to conclude that they provide enough information to make a valid judg- ment. Even though some were published long ago, they are still aggressively promoted. In many cases, authors sound impartial and factual, even though they are not. 3. Proponent organizations. The International As- sociation of Cancer Victors and Friends (IACVF) was founded by Cecile Hoffman, a cancer patient who be- lieved her life had been saved by the use of Laetrile. Mrs. Hoffman died in 1969 of metastatic cancer. Other groups include the Cancer Control Society, which offers tours of the Mexican clinics; HealthKeepers Alliance; and the National Health Federation (see Chapter 11).86 Their activities have included (a) publishing a magazine or newsletter, (b) selling books and tapes, (c) orchestrat- ing letter-writing campaigns, (d) referring patients to “alternative” treatment facilities, and (e) sponsoring conventions that attract many participants. 4. Commercial information services. Several pro- ponents of questionable methods provide individual clients with reports on cancer treatment based on com- puter searches and other sources. Some reports include information about conventional treatment but are slanted toward unconventional treatment. 5. Radio and television programs. Proponents of controversial remedies are frequently interviewed on talk shows. A few talk show hosts, most notably Gary Null (syndicated from a station in New York City), give a great deal of favorable publicity to questionable cancer treatments. 6. Internet channels. Claims for various methods are promoted through Web sites, Internet radio and video broadcasts, news and patient support groups, and unsolicited e-mail messages. An expert review team that rated 32 popular Web sites that offer information on “complementary and alternative” cancer methods concluded that most of the sites issued unsubstantiated recommendations.87
One of the Internet’s most dangerous promoters of cancer misinformation is Lorraine Day, M.D., who
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claims to have cured herself of terminal breast cancer with “natural” methods (see Personal Glimpse box). 7. Sponsorship by prominent individuals. Entertain- ers, socially prominent persons, celebrities, congres- sional representatives, and others may be persuaded to promote various questionable methods of cancer management. These individuals often are sincere but lack the scientific background to judge the merit of the approach and may not be aware of the strict criteria necessary for scientific investigation before a drug or method is acceptable for medical use. 8. “Integrative” Cancer Centers. Institutions that provide standard treatment may also provide question- able treatments or exaggerate the quality of their offer- ings. The most notable is Cancer Treatment Centers of America (CTCA), which manages hospitals in several cities and advertises frequently on television and in health-related magazines. Many of its ads have featured testimonials from patients who said CTCA had helped them after other doctors had given up. The ads claimed
that CTCA’s facilities offer innovative treatment and “specialize in treating cases other hospitals call hope- less.” However, no statistics comparing their survival rates with those of other facilities have been published in a scientific journal. Critics have charged that in addi- tion to standard approaches, CTCA patients have been subjected to questionable treatments, expensive and unnecessary tests, and hospital treatment in situations where less expensive outpatient treatment is standard practice.90 In 1996 CTCA settled FTC charges that it had falsely represented that (a) survival rates for its cancer patients were among the highest recorded and (b) the consumer testimonials in its ads reflected the typical experience of its patients.91
In recent years, many medical training centers and otherwise reputable hospitals have added “alternative” and/or “complementary” services that have little or no value.
TrusTworThY inforMaTion sourCes
The ACS, the NCI, and the University of Pennsylvania Cancer Center maintain comprehensive Web sites. The ACS and NCI also answer telephone queries and distribute printed materials. Information on treatment protocols, results, and clinical trials is available through NCI’s Physician Data Query (PDQ), a computerized database maintained and updated monthly. This enables most cancer patients to benefit from the latest scientific knowledge without having to travel far. Quackwatch and its subsidiary Web site, Cancer Treatment Watch, have comprehensive information about questionable methods, and the ACS has published a well-reasoned book about “alternative methods.”92 The Consumer Tip box tells how to access these sources.
TreaTMenT guidelines
FDA historian Wallace Janssen93 suggested the following treatment guidelines for people with cancer:
• Don’t bet your life on any method that has not been FDA- approved for marketing or research.
• Go after the best possible treatment offered by known cancer experts.
• Avoid any “fad” treatment promoted by a crusading group of laypersons.
• Don’t trust testimonials from laypersons who think they have been cured by unrecognized treatments. Such people mean well but are not qualified to diagnose or to determine what cured them.
• Stick with a prescribed treatment even if results are not immediately apparent.
Personal Glimpse
“Trust Me. I’m a Doctor” Lorraine Day, M.D., a nonpracticing orthopedic sur- geon, claims to have cured herself of terminal breast cancer with a 10-step program that featured a raw-food diet and prayer. After a biopsy showed that a small breast lump was malignant, she had a local operation to remove the visible tumor. According to her story, the cancer recurred and quickly grew to the size of a grapefruit, but she refused further standard care until severe pain forced her to have an operation to reduce the tumor’s size. After this was done, she claims, the doctors sent her home to die, but she cured herself with “natural methods.” Day posted her first biopsy report on her Web site but refused to release additional records that would show whether any cancer remained after the second operation.88 After an infomercial producer began marketing Day’s videotapes on cable television, the Council of Better Business’s National Advertising Division (NAD) requested evidence that Day still had cancer after her second surgery and that doctors had “sent her home to die.” When none was provided, NAD concluded that her claim lacked a reasonable basis.89
Day claims that standard cancer treatment has never cured anyone. Her offerings are especially dan- gerous because many people who are frightened about standard treatment or who resonate with her Christian beliefs conclude that she is credible.
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• Have faith in experts who are devoting their careers to cancer research and treatment.
• If a specialist “gives up,” look for another. A good physician does not abandon a patient to hopelessness.
ConsuMer proTeCTion laws
The FDA, which has jurisdiction over drugs and devices marketed in interstate commerce, has been able to drive many fraudulent cancer treatments out of the Ameri- can marketplace. Regulation of health professionals is handled primarily by state licensing agencies. The vigor with which government officials work to protect the public against cancer frauds varies consider- ably from agency to agency and depends in part on the extent of other matters competing for their attention. It also depends on the extent to which fraud victims (or their survivors) complain and press for action.
suMMarY
Cancer is a general term applied to more than 100 dis- eases characterized by cell growth. Early diagnosis and treatment are likely to produce the most favorable results. Patients may turn to quackery because of fear, loss of hope, inadequate information, and other psychosocial factors. This chapter describes many types of quackery and tells how to obtain competent professional help.
referenCes
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3. Siegel R and others. Cancer Statistics, 2011. CA—A Cancer Journal for Clinicians 61:212–236, 2011.
4. Meister K and others. Cigarettes: What the Warning Label Doesn’t Tell You. New York, 2003, American Council on Sci- ence and Health.
5. Meister K and others. America’s War on Carcinogens. New York, 2005, American Council on Science and Health.
6. U.S. Surgeon General issues new national health advisory on radon. U.S. Department of Health & Human Services news release, Jan 13, 2005.
7. Krishnan SS. The HPV Vaccine Controversy: Sex, Cancer, God, and Politics: A Guide for Parents, Women, Men, and Teenagers. Westport, CT, Praeger Publishers, 2008.
8. Health CW. Electromagnetic field exposure and cancer: A review of epidemiologic evidence. CA—A Cancer Journal for Clinicians 46:29–44, 1996.
9. Leikind B. Do cell phones cause cancer? Skeptic Magazine 15: 30–34, 2010.
10. Estabrook RW and others. Carcinogens and Anticarcinogens in the Human Diet. Washington, D.C., 1996, National Academy Press.
11. Artificial sweeteners and cancer. NCI Fact sheet, Aug 5, 2009.
12. Hardman AE. Physical activity and cancer risk. Proceedings of the Nutrition Society 60:107–113, 2001.
13. Tumor grade: Questions and answers. National Cancer Institute fact sheet, May 19, 2004.
14. Staging: Questions and answers. National Cancer Institute fact sheet, Jan 6, 2004.
15. Fishman J and others. Cancer and the media: How does the news report on treatment and outcomes? Archives of Internal Medicine 170:515-518, 2010.
16. Goozner M. Covering cancer: Comment on “Cancer and the Media.” Archives of Internal Medicine 170:518-520, 2010.
17. Shaving chemotherapy: Killing patients with kindness. Medical World News, pp 24–25, April 28, 1986.
18. Biological therapies: Questions and answers. National Cancer Institute fact sheet, June 13, 2006.
19. Taking part in cancer treatment research studies. National Cancer Institute Web site, July 17, 2007.
20. Delaney P. Understanding clinical trials from the patient’s perspective. Coping, May/June 1997.
21. NAS Committee on Diet, Nutrition, and Cancer. Diet, Nutrition, and Cancer. Washington, D.C., 1982, National Academy Press.
Personal Glimpse
Concern about Cost94
Two NIH scientists have urged cancer specialists, researchers, regulators, drug companies, insurance companies and the public to look more closely and set limits on the use and pricing of anticancer drugs. The scientists noted that 90% of the anticancer drugs and biologics approved by the FDA from 2004 through 2008 cost more than $20,000 for a 12-week regimen, but many offer an additional survival benefit of only 2 months or less. Cetuximab treatment of non-small cell lung cancer for 18 weeks costs about $80,000 but prolongs the patient’s life for a median of only 1.2 months. The researchers note that many studies that do produce a small survival benefit do not take into account the patient’s quality of life. To illustrate the absurdity of this cost, they also extrapolate that if all 550,000 people who die of cancer each year could be kept alive for a year at equivalent cost, the total would be $440 billion without any of them being cured.
Trustworthy Sources of Advice about Cancer ACS: www.cancer.org (800) 227-2345 NCI: www.cancer.gov/aboutnci/cis (800) 226-4237 cancernet.nci.nih.gov cancertrials.nci.nih.gov Oncolink: oncolink.upenn.edu Quackwatch: www.quackwatch.org www.cancertreatmentwatch.org
√ Consumer Tip
Chapter Sixteen Cancer 347
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24. Kritchevsky D. Diet and cancer. CA—A Cancer Journal for Clinicians 41:328–333, 1991.
25. Fuchs CS and others. Dietary fiber and the risk of colorectal cancer and adenoma in women. New England Journal of Medi- cine 340:169–176, 1999.
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27. Tsubono Y and others. Green tea and the risk of gastric cancer in Japan. New England Journal of Medicine 344:632–626, 2001.
28. Sano T, Sasako M. Green tea and gastric cancer. New England Journal of Medicine 344:675, 2001.
29. Brigden ML. Unorthodox therapy and your cancer patient. Postgraduate Medicine 81:271–280, 1987.
30. Cassileth BR and others. Contemporary unorthodox treatments in cancer medicine. Annals of Internal Medicine 101:105–112, 1984.
31. American Cancer Society. Questionable methods of cancer management. New York, 1992, The Society.
32. Young JH. Laetrile in historical perspective. In Merkle GE, Petersen JC, editors. Politics, Science, and Cancer: The Laetrile Phenomenon. Boulder, Colo., 1980, Westview Press.
33. Wilson B. The rise and fall of Laetrile. Quackwatch Web site, Feb 17, 2004.
34. American Cancer Society. Unproven methods of cancer manage- ment: Laetrile. CA—A Cancer Journal for Clinicians 1:187–192, 1991.
35. Moertel C and others. A clinical trial of amygdalin (Laetrile) in the treatment of human cancer. New England Journal of Medicine 306:201–206, 1982.
36. Milazzo S and others. Cochrane Database of Systematic Reviews 2011, Issue 11. Art. No.: CD005476. DOI: 10.1002/14651858. CD005476.pub3.
37. Green S. Immunoaugmentative therapy. An unproven cancer treatment. JAMA 270:1719–1723, 1993.
38. Questionable methods of cancer management: Immuno-aug- mentative therapy (IAT). CA—A Cancer Journal for Clinicians 41:357–363, 1991.
39. Centers for Disease Control and Prevention. Isolation of human T-lymphotropic virus type III/lymphadenopathy-associated virus from serum proteins given to cancer patients—Bahamas. Morbidity and Mortality Weekly Report 34:489–491, 1985.
40. Mathews J. Media feeds frenzy over shark cartilage as cancer treatment. Journal of the National Cancer Institute 85:1190– 1191, 1993.
41. U.S. District Judge issues permanent injunction against Lane Labs-USA, Inc. and orders firm to refund money to purchasers of illegally marketed unapproved drugs. FDA news release, July 13, 2004.
42. Loprinzi CL and others. Evaluation of shark cartilage in patients with advanced cancer. Cancer 104(1), July 1, 2005.
43. Congress, Office of Technology Assessment. Unconventional Cancer Treatments, OTA-H-405. Washington, D.C., 1990, U.S. Government Printing Office.
44. Barrett S. The bizarre claims of Hulda Clark. Quackwatch Web site, Nov 9, 2004.
45. Tyler VE. Pau d’arco. Nutrition Forum 2:8, 1985. 46. American Cancer Society. Unproven methods of cancer man-
agement: Macrobiotic diets for the treatment of cancer. CA—A Cancer Journal for Clinicians 39:248–251, 1989.
47. Lowell J. The Gerson clinic. Nutrition Forum 3:9–12, 1986. 48. Austin S, Dale EB, DeKadt S. Long-term follow-up of cancer
patients using Contreras, Hoxsey and Gerson therapies. Journal of Naturopathic Medicine 5(1):74–76, 1994.
49. Green S. A critique of the rationale for cancer treatment with coffee enemas and diet. JAMA 268:3224–3227, 1992.
50. American Cancer Society. Questionable methods of cancer man- agement: Questionable “nutritional” therapies in the treatment of cancer. CA—A Cancer Journal for Clinicians 43:309–319, 1993.
51. Brooks SP. Some notes on cancer and the immune system. Cancer Treatment Watch Web site, March 30, 2010.
52. Working group on unproven methods in oncology. Iscador. File No. 10E, Bern, 1984, Swiss Cancer League..
53. Steuer-Vogt MK and others. The effect of an adjuvant mistletoe treatment programme in resected head and neck cancer patients: A randomised controlled clinical trial. European Journal of Cancer 37:23–31, 2001.
54. Goebell PJ. Evaluation of an unconventional treatment modal- ity with mistletoe lectin to prevent recurrence of superficial bladder cancer: A randomized phase II trial. Journal of Urology 168:72–65, 2002.
55. American Cancer Society. Questionable methods of cancer management: Hydrogen peroxide and other “hyperoxygenation” therapies. CA—A Cancer Journal for Clinicians 43:47–55, 1993.
56. Green S. Oxygenation Therapy: Unproven treatments for cancer and AIDS. Scientific Review of Alternative Medicine 2(1):6–12, 1998.
57. Gelb L. Unproven cancer treatments: Help or hoax? FDA Con- sumer 26(2):10–15, 1992.
58. Segal M. Court says cancel the CanCell. FDA Consumer 27(4):40–41, 1993.
59. National Cancer Institute studies of hydrazine sulfate. NIH news release, Aug 19, 1997.
60. London WM. The Penthouse politics of cancer: The promotion of hydrazine sulfate and a medical conspiracy theory. Priorities for Health 10(4):7–13, 34–35, 1998.
It’s Your Decision
You have a serious disease such as cancer. Your doctor has recommended chemotherapy but is not optimistic about the outcome. You are not sure whether the treatment will benefit you enough to be worth putting up with its side effects. You have also heard about a clinic in Tijuana, Mexico, that offers various drugs not available in the United States and guarantees that its treatment will help. What information would you need to make an intelligent decision about your options?
Part Four Personal Health Concerns348
77. Friedlander ER. Mental imagery. In Barrett S, Cassileth BR, editors. Dubious Cancer Treatment. Tampa, 1990, American Cancer Society, Florida Division.
78. American Cancer Society. Unproven methods of cancer man- agement: O. Carl Simonton, MD. CA—A Cancer Journal for Clinicians 32:59, 1982.
79. Petticrew M and others. Influence of psychological coping on survival and recurrence in people with cancer: Systematic review. British Medical Journal 325:1066–1075, 2002.
80. Coyne JC and others. Psychotherapy and survival in cancer: The conflict between hope and evidence. Psychological Bulletin 133:367-394, 2007.
81. Stefanek ME and others. Finding what is not there: Unwarranted claims of an effect of psychosocial intervention on recurrence and survival. Cancer 115:5612–5616, 2009.
82. American Cancer Society. Kelley malignancy index and ecology therapy. In Unproven Methods of Cancer Management. New York, 1971, The Society.
83. Chabot JA and others. Pancreatic proteolytic enzyme therapy compared with gemcitabine-based chemotherapy for the treatment of pancreatic cancer. Journal of Clinical Oncology 28:1979–1981, 2010.
84. South J. The Manner seminar. Nutrition Forum 5:61–67, 1988. 85. Cassileth BR. Quoted in Nourse AE. Quack cancer cures. Good
Housekeeping, pp 58–69, Sept 1983. 86. American Cancer Society. Unproven methods of cancer man-
agement: National Health Federation. CA—A Cancer Journal for Clinicians 41:61–64, 1991.
87. Schmidt K, Ernst E. Assessing websites on complementary and alternative medicine for cancer. Annals of Oncology 15:733– 742, 2004.
88. Barrett S. Stay Away from Dr. Lorraine Day. Quackwatch Web site, Feb 7, 2010.
89. Barrett S. NAD concludes that Lorraine Day infomercial is misleading. Infomercial Watch Web site, Dec 13, 2004.
90. Weiss J. Critics say cancer ads deceptive. Dallas Morning News, June 21, 1992, pp 1A, 26A.
91. Companies that purport to successfully treat cancer agree to settle FTC charges over their claims. FTC News, March 13, 1996.
92. Ades T and others. American Cancer Society Complete Guide to Complementary & Alternative Cancer Therapies. Atlanta, 2009, American Cancer Society.
93. Janssen WF. Cancer quackery: Past and present. FDA Consumer 11(6):27–32, 1977.
94. Fojo T, Grady C. How much is life worth: Cetuximab, non-small cell lung cancer, and the $440 billion question. Journal of the National Cancer Institute 101:1044–1048, 2009.
61. Blackstein ME, Sergsagel DE. Report to the Ontario Ministry of Health on the treatment of cancer patients with antineoplastons and the Burzynski clinic in Houston, Texas. Undated, circa 1983.
62. Green S. “Antineoplastons”: An unproved cancer therapy. JAMA 267:2924–2928, 1992.
63. Texas Attorney General’s Office. Morales halts use of unap- proved cancer treatment. News release, Feb 10, 1998.
64. The antineoplaston anomaly: How a drug was used for decades in thousands of patients, with no safety, efficacy data. Cancer Letter, Sept 25, 1998.
65. Administration of the Special Access Programme with respect to 714-X: Decision of the Federal Court, Trial Division of July 28, 2006. Health Canada notice, Oct 2, 2006.
66. State health director warns consumers about prescription drugs in herbal products. California Department of Health Services news release, Feb 7, 2002.
67. Cancer “cure” challenged. Consumer Reports on Health 2:21–22, 1990.
68. Mirkin G. Acid/alkaline theory of disease is nonsense. Quackwatch Web site, Jan 11, 2009.
69. American Cancer Society. Unproven methods of cancer man- agement: Livingston-Wheeler therapy. CA—A Cancer Journal for Clinicians 40:103–107, 1990.
70. Cassileth BR and others. Survival and quality of life among pa- tients receiving unproven as compared with conventional cancer therapy. New England Journal of Medicine 324:1180–1185, 1991.
71. American Cancer Society. Unproven methods of cancer manage- ment: Fresh cell therapy. CA—A Cancer Journal for Clinicians 41:126–128, 1991.
72. American Cancer Society. Unproven methods of cancer manage- ment: Greek Cancer Cure. CA—A Cancer Journal for Clinicians 40:368–371, 1990.
73. Baratz RS. Why you should stay away from insulin potentiation therapy (IPT). Quackwatch Web site, March 10, 2007.
74. American Cancer Society. Questionable methods of cancer management: Electronic devices. CA—A Cancer Journal for Clinicians 44:115–127, 1994.
75. Barnes C. Testimony before the Subcommittee on Health and Long-Term Care of the U.S. House of Representatives Select Committee on Aging. In Pepper C and others. Quackery: A $10 Billion Scandal. Washington, D.C., 1984, U.S. Government Printing Office.
76. Gellert G, Maxwell RM, Siegel BS. Survival of breast cancer patients receiving adjunctive psychosocial support therapy: A 10-year follow-up study. Journal of Clinical Oncology 11:66–69, 1993.
Drug ProDucts
The desire to take medicine is perhaps the greatest feature which distinguishes man from animals.
Sir William OSler
No drug is perfectly safe. Any drug powerful enough to do good is powerful enough to do harm.
mOrtOn mintz
the therapeutic nightmare
Chapter OnePart Five Chapter Seventeen
© AARON BACALL
Part Five Other Products and Services350
or controlling diseases. They include common remedies such as pain relievers, antacids, laxatives, and cough and cold remedies, which consumer can purchase off the shelf at drugstores, supermarkets, and many other retail outlets or from online sources. A few nonprescription products are behind-the- counter (BTC) drugs, which require authorization by the pharmacist. The Combat Methamphetamine Epidemic Act of 2005 banned OTC sales of cold medicines that contain pseudoephedrine and similar ingredients that can be used to illegally manufacture methamphetamine (an addictive drug). But pharmacists can dispense limited quantities of pseudoephedrine from a locked cabinet or behind the counter to people who present photo iden- tification.1 Emergency contraception (Plan B), which is discussed in Chapter 19, is also available BTC to women 18 years or older, Under the Food, Drug, and Cosmetic Act, manufac- turers may not label or market drugs for uses that lack FDA approval. Except for products legally defined as controlled drugs, however, federal law does not limit how physicians may use approved drugs. Drugs can be marketed under a brand name or simplified chemical name of their active ingredient(s). New prescription drugs, which are marketed under brand names, are protected by patents. After the protection period ends, other manufacturers can copy and market a drug under its simplified chemical name or another brand name. Originally patents were good for 17 years from the early stages of the drug’s development. The federal Drug Price Competition and Patent Term Res- toration Act (1984) extended the protection for up to 5 more years to compensate for the time required to get FDA approval. The 1994 General Agreement on Tariffs and Trade (GATT) Act extended patent protection to 20 years from the time the manufacturer files for a patent. A
• Be sure to learn the name, purpose, dosage, and significant side effects of any drug prescribed for you and whether any special instructions must be followed.
• Ignore nonprescription drug advertising. Learn what ingredients are effective for the problem at hand and select products that contain those ingredients.
• Drug prices vary considerably, so shopping for the best price is prudent.
• A well-stocked “home pharmacy” will facilitate self-care of common problems.
• Trustworthy information about drugs is available in reference books and on Web sites.
KeeP these Points in MinD as You stuDY this chaPter
Key Concepts
This chapter focuses on common drug products and strategies for using them wisely. It explains the differences between prescription and non-
prescription products, describes the training and profes- sional activities of pharmacists, states why generic drugs usually provide good value, describes how government regulation has improved the quality of nonprescription drugs, and recommends sources of comprehensive information about individual drugs.
MeDication tYPes
Two basic types of medications can be legally purchased in the United States: prescription (℞ ) drugs and nonpre- scription drugs. Drugs are used medicinally to produce specific intended effects (main effects). All other effects are called side effects. Adverse reactions are side effects that are considered serious or problematic. Prescription drugs can be prescribed by a physician or other designated health professional, such as a dentist, podiatrist, or nurse practitioner, and most commonly are dispensed by registered pharmacists. They are sometimes referred to as ethical or legend drugs. They require professional supervision because (a) they are generally more potent than nonsprescription drugs, (b) they pose a greater risk of adverse side effects, and (c) the conditions for which they are prescribed are generally unsuitable for self-treatment because expert knowledge is required for their diagnosis and management. By law, a pharmacist cannot fill or refill a prescription without an order from an authorized prescriber. There are two types of nonprescription drugs. The vast majority are over-the-counter (OTC) drugs which consumers can select as they wish. Most OTC products are intended for relieving the symptoms of relatively benign, self-limiting conditions rather than for curing
Chapter Seventeen Drug Products 351
federal court ruling enables 94 drugs to qualify for both extensions (up to 25 years). When a patent expires, the original manufacturer may market a mid-priced generic version (“branded generic”) under a new brand name to compete with other generic versions.2 Drugs sold under their simplified chemical name are called generic drugs. FDA regulations require them to undergo limited testing to demonstrate equivalence to their brand-name counterparts. Generic drugs cost less—often considerably less—but some controversy exists over whether they actually are equivalent. Al- though their active ingredients are identical, their inert ingredients (e.g., binders, dyes, coatings) may affect their bioavailability (the proportion that enters the circulation and thus is available to have an active effect) and bio- equivalence. Different formulations of a drug are con- sidered bioequivalent if equal doses administered under
similar conditions result in no significant difference in bioavailability. Bioequivalence is assumed to result in therapeutic equivalence (equivalent medicinal value). About 75% of prescriptions are for generic drugs.
PharMacists
Pharmacy is concerned with procuring, storing, dis- pensing, and using medications, related substances, and appliances. Pharmacists are also trained in methods of compounding and manufacturing drugs and testing them for purity and potency, although most of the items they dispense are compounded by drug manufacturers. The Accreditation Council for Pharmacy Education accredits about 90 schools and colleges of pharmacy in the United States. Two years of prepharmacy college work are required for admission. In 1992 the American Association of Colleges of Pharmacy recommended that pharmacy schools offer a 4-year doctor of pharmacy (Pharm.D.) curriculum for their entry-level degree. As of fall 2004, all U.S. pharmacy schools do so. The Pharm.D. program includes clinical practice under fac- ulty supervision. Pharmacists who wish to do research may obtain an additional master’s or Ph.D. degree. With specialized training and passage of an examination by the Board of Pharmaceutical Specialties, certification is available in nuclear pharmacy (use of radioactive drugs for diagnosis and therapy), nutrition support pharmacy, oncology pharmacy (cancer drug treatment), pharmaco- therapy, and psychiatric pharmacy. Pharmacists practice in community pharmacies, hospitals, clinics, extended care facilities, and nurs- ing homes. All states require a license as a registered pharmacist (R.Ph.) to practice pharmacy. This requires graduation from an accredited college of pharmacy, a prescribed period of internship (in most states), and passage of an examination given by the state board of pharmacy. There are about 250,000 pharmacists in the United States. About half the states have granted limited power to prescribe drugs, but the majority of eligible pharma- cists have not exercised this privilege.
Pharmacy Technicians Pharmacy technicians help with activities not requiring the professional judgment of a pharmacist. They can help fill and label prescriptions and do many other administra- tive and clerical tasks. Educational programs are avail- able, but most states have no formal requirements for training. Certification by the Pharmacy Technician Cer- tification Board (PTCB), which requires a high school
Figure 17-1. Pharmacist strikes a blow for public health. Adrian Thomas, owner of the Thomas Pharmacy in Meyersville, Pennsylvania, decided it was hypocritical to give health advice in one part of his store and sell health-destroying products in another. In 1992 he burned his entire tobacco inventory, along with his license to sell tobacco products. He told reporters he was tired of seeing his customers die of cancer and heart disease.
Photo courtesy of Johnstown Tribune-Democrat.
Part Five Other Products and Services352
diploma and passage of an examination, entitles use of the certified pharmacy technician (CPhT) credential. As of March 2011, 16 of the 42 states that regulate pharmacy technicians require PTCB certification.
Problem Areas Most pharmacists who work in retail pharmacies have a serious potential conflict of interest. On the one hand, they are professionals, expected to be knowledgeable about drugs and to dispense them in a responsible and ethical manner. On the other hand, their income depends on selling products. Before the FDA’s OTC Drug Review drove most of the ineffective ingredients out of OTC drug products, few pharmacists protested or attempted to protect their customers from wasting money on prod- ucts that did not work. Today virtually all pharmacies carry irrationally formulated dietary supplements, and many stock dubious herbal and homeopathic products in addition to drugs. Pharmacists are also the only recognized health professionals who sell tobacco products, which cause more death and years of lost life than any other consumer products. Although many pharmacists have stopped sell- ing such products (Figure 17-1), others do not consider tobacco sales unethical. The American Pharmacists
Association’s code of ethics does not state that pharma- cists have a duty to prevent dubious products from lining their shelves. A few states have laws against pharmacists selling ineffective products, but these laws have never been applied to the sale of nonprescription products. Although chain-store pharmacists do not control what gets placed on their shelves, they share responsibility for the fact that their profession as a whole has made little or no effort to oppose the marketing of irrational products. Pharmacy trade publications have suggested that “natural products” offer opportunities to make up for prescription drug revenues lost as a result of man- aged care and other cost-containment programs. A few companies have marketed elaborate systems in which pharmacists advise customers to buy supplement prod- ucts to replace nutrients that their prescription drugs are supposedly depleting. These companies also encouraged pharmacists to recommend supplements, herbs, and ho- meopathic products for many diseases.3 W. Steven Pray, Ph.D., D.Ph.,4 a professor at the Southwestern Oklahoma State University College of Pharmacy, has noted that nearly every communication channel through which pharmacists receive information about these products has portrayed them more favorably than they deserve.
Name and dose of drug
Signa (“Write on label”)
DEA# AB1234567
DEA number (required for controlled substances)
Dosage form and number of dosage units
Directions for use
Number of refills permitted
Dale Z. Smith, M.D. Medical Arts Building
Anytown, US 12356 (803) 222-3330
naMe ____________________________ age __________ aDDress __________________________ Date _________
Refill ____ times Signature of practitioner
Figure 17-2. Anatomy of a prescription. This one prescribes one tablet daily at bedtime of simvastatin (a drug to improve cholesterol levels).
Simvastatin 20 mg
Tabs #100
Sig: i hs
Kyle Rogers
10/24/1120 University Ave.
29
2 Dale Z. Smith, M.D.
Chapter Seventeen Drug Products 353
If asked directly whether an ineffective product is worthwhile, most pharmacists will answer to the best of their ability. However, many are poorly informed. In 1987 two pharmacy school professors sent a question- naire to 1000 pharmacists in the Detroit metropolitan area and received 197 responses. Among the 116 who identified their five most-common reasons for recom- mending vitamins or minerals, 66 (56%) listed fatigue and 57 (49%) listed stress.5 (Neither reason is valid.) Homeopathic products have no therapeutic value (see Chapter 8), but a study at the University of Minnesota School of Pharmacy published in 2006 found that only 26% of faculty members and 3% of senior Pharm.D. students considered homeopathy ineffective and 23% of faculty members and 35% of students said they had no opinion.6
Bruce Bouts, R.Ph., M.D.,7 an adjunct professor of clinical pharmacy at Ohio Northern University, has expressed concern about inappropriate compounding of drugs. Compounding (creation of a drug product by mixing ingredients) has legitimate uses and is most often done honestly at physician request. However, some compounding pharmacists are networked with “alternative” practitioners to provide products that lack scientific substantiation, and some compounders are marketing such products independently. Quality control is also a significant problem. Bouts advises consumers to avoid compounded products that are sustained-release, administered by injection or inhalation, or available in brand-name or generic form. The FDA8 advises against using compounded prod- ucts that are essentially copies of a commercially avail- able FDA-approved product. In 2007, the agency noted that since 1990 it had received reports of more than 200 adverse events involving 71 compounded products.
PrescriPtion Drugs
Prescriptions drugs are often used incorrectly by the patient, and many hospital admissions and deaths can be traced to drug-induced problems. Many people fail to fill prescriptions they receive, take doses that are too small or too large, take their medication at the wrong intervals, forget to take one or more doses, or discontinue medication too soon. Cramer and others9 studied the compliance of 26 epileptic patients who used special bottles equipped with a microprocessor that recorded when the bottles were opened and closed. Even though the patients had a serious disease and were closely monitored, they took an average of only 76% of their medication doses as prescribed.
It is useful to know how to read a physician’s pre- scription. Figure 17-2 illustrates the typical format for prescriptions, and Table 17-1 provides the common abbreviations used by doctors. It is also helpful to be familiar with prescription labels and to understand them. Labels should state:
• Patient’s name • Physician’s name • Pharmacy name, address, and telephone number • Name of the medication • The number of units (tablets, capsules, ounces, etc.) • The amount of each active ingredient in each unit • How often and when to take the medication • How much to take each time • Any special instructions for use • Pertinent warnings regarding sedation or allergy • Number of refills permitted
When dispensing a generic drug, some pharmacists indicate which brand-name drug is equivalent.
coMMon PrescriPtion abbreviations* Table 17–1
Latin ad libitum ante cibos bis in die capsule gutta hora somni per os post cibum pro re nata quaque 4 hora quaque die quater in die ter in die ut dictum
Metric units:
Quantity:
Abbreviation
ad lib ac bid cap gt hs po pc prn q4h qd qid tid ut dict
cc mg ml g
i, ii, iii
Meaning freely, as needed before meals twice a day capsule drop at bedtime orally after meals as needed every 4 hours daily four times a day three times a day as directed
cubic centimeter milligram milliliter gram (1000 mg)
1, 2, 3
*The R in the symbol is an abbreviation of the Latin verb recipte, meaning “take thou.” The thou refers to the pharmacist. The “tail” on the R is a contraction of the sign of Jupiter. Thus the symbol is an order to the pharmacist to “take in the name of Jupiter,” with the physician invoking the name of Jupiter to ensure that the pharmacist does not make a mistake in carrying out the instructions.
Part Five Other Products and Services354
generic vs branD-naMe Drugs
Drugs may be identified by generic or brand name. The term generic refers to the name of the active chemical or chemicals in a drug. Generic names are written in lowercase letters. The brand name (trade name) is the manufacturer’s exclusive property, usually by reason of trademark rights. The first letter of a brand name is capitalized. Some drugs are marketed under only one brand name, whereas others are marketed under more than one. Brand-name manufacturers also market most of the generic drugs, whereas a few hundred smaller companies make the rest. The fact that identical drugs are marketed under different names is a potential source of confusion for consumers and possibly even for physicians. All drug products must meet FDA requirements for form, strength, route of administration, safety, purity, and effectiveness. The official standards of identity, strength, and purity are set forth in the United States Pharmacopeia and the National Formulary (USP-NF), which is continuously revised by experts. The compen- dium is published by the United States Pharmacopeial Convention, an independent organization that establishes officially recognized standards for medicines and related products. The 2009 update, USP32-NF27, contains more than 4000 monographs on drug substances and dosage forms for medicines and dietary supplements. Product labels sometimes contain the term USP or NF to indicate that the active ingredient meets USP or
NF standards. Therapeutic equivalence is established by demonstrating bioequivalence. If the rate of absorption and the blood levels achieved are allowably close to those of a brand-name drug in the same dosage, a generic substance is considered bioequivalent. The Drug Price Competition and Patent Term Res- toration Act requires the FDA to expedite approval of generic drugs. To approve a generic drug for marketing, the FDA does not have to judge the safety and effective- ness of its active ingredient(s), since the same chemical substance(s) has already been approved for use in the drug’s brand-name counterpart. However, the FDA must test for and approve the bioequivalence of generic drugs. FDA officials state that properly evaluated generic drugs are therapeutically equivalent to their brand-name counterparts.10 More than 7500 different generic drugs have FDA approval. All states let pharmacists substitute a generic product if authorized by a physician. Some states require that when a generic version of a prescribed drug is available, it must be dispensed unless the physician’s prescription forbids substitution. Generic drugs are usually less expensive than brand- name drugs. Table 17-2 compares the retail prices of several commonly prescribed products. For consumers to realize savings it is necessary for doctors and phar- macists to make generic drugs available. Pharmacies pay less for generics than for brand-name prescription drugs, but they do not always pass these savings to the consumer; in some stores, consumers have paid higher
coMParative cost oF coMMonlY PrescribeD branD-naMe anD generic Drugs
Table 17–2
Brand Name Ativan Calan SR
Flexeril Lasix Prozac Valium Zantac Zithromax Zocor Zovirax
Drug Type or Purpose Antianxiety agent Calcium-channel blocker (for high
blood pressure) Muscle relaxant Diuretic Antidepressant Antianxiety agent, muscle relaxant H2
blocker (for ulcers and acid reflux) Antibiotic Cholesterol-lowering agent Antiviral (for herpes infections)
Generic Name lorazepam verapamil
cyclobenzaprine furosemide fluoxetine diazepam ranitidine azithromycin simvastatin acyclovir
Dosage Brand Generic 1 mg $105.12 $ 44.97 120 mg 89.97 49.97 10 mg 176.60 18.97 40 mg 57.97 16.20 10 mg 588.95 26.97 5 mg 321.95 13.95 300 mg 684.94 24.97 250 mg 915.92 285.99 40 mg 459.97 73.97 400 mg 603.30* 51.65*
Price per 90
*prices are for 100 tablets. Source: Drugstore.com Web site, June 2011.
Chapter Seventeen Drug Products 355
prices for generics. Because prices vary from store to store, it is advisable to shop for drugs. Many pharmacists are willing to quote prices over the telephone. Some manufacturers try to frighten consumers away from generics because brand-name drugs generally are priced higher and yield larger profits. These companies claim that generics are not as safe, that they don’t do the job as well and take longer to act, and that patients may suffer side effects. The FDA Consumer11 has reported that all of these claims are myths, and Consumer Re- ports has also criticized this tactic. However, authorities generally agree that if a generic drug is used over a long period and appears to be working, it is best to not switch to another source when refilling the prescription. Using a single brand will avoid the possibility of potency varia- tion from one manufacturer to another.
Drug interactions
Two or more products taken at the same time may inter- fere with each other’s absorption into the bloodstream, distribution within the body, metabolism (biochemical reactions), or excretion.12 A drug may also multiply the effect of another drug. For example, aspirin increases the clot-preventing ability of anticoagulants and can cause someone on anticoagulant therapy to have a hemorrhage. Thousands of people who combine alcohol with other drugs are treated in hospital emergency rooms yearly, and some die. Alcohol depresses the central ner- vous system, as do narcotics, barbiturates, tranquilizers, sedatives, and certain prescription painkillers. Alcohol causes drowsiness, and, depending on the amount con- sumed, can affect walking, talking, and driving. When mixed with another depressant drug, the combined effect may be greater than the sum of the two drug actions.13
Many OTC cough, cold, and allergy medicines con- tain antihistamines, and some also contain alcohol. When these products are taken with alcoholic beverages, they can increase drowsiness and be dangerous to someone driving an automobile or operating machinery. Other drugs with adverse interactions with alcohol include oral antidiabetic drugs, certain antibiotics, and certain classes of drugs used against angina pectoris (chest pain) and high blood pressure. Foods can interact with drugs, making them work faster or slower or preventing them from working at all. For example, the calcium in dairy products interferes with the absorption of tetracycline (an antibiotic), and carbonated beverages and fruit juices with a high acid content can cause some drugs to dissolve in the stomach rather than in the intestine.
Grapefruit juice can block the action of certain en- zymes in the intestinal wall and liver that are needed to absorb and detoxify drugs. As a result, grapefruit juice increases the body’s absorption of certain drugs and slows their breakdown in the liver, causing the drugs to have higher-than-desirable blood levels and remain longer in the body. More than 30 commonly prescribed drugs carry a warning not to consume grapefruit or grapefruit juice when using them. The Grapefruit-Drug Interactions Web site (www.powernetdesign.com/grape- fruit) has comprehensive information on this topic. Many herbs and dietary supplements can have unfavorable interactions with drugs. The most notable include St. John’s wort, vitamin E, ginseng, and ginkgo biloba.14 An interaction checker is available to subscrib- ers to the Natural Medicines Comprehensive Database www.naturaldatabase.com and ConsumerReportsHealth. org. Patients can minimize the likelihood of taking an ad- verse combination of products by telling their physician when they are taking drugs (including herbal products) from another source and by carefully following the directions when using any drug product.
Drug recalls
Drug recalls are actions taken by a manufacturer to remove a product from the market. Recalls may be con- ducted on a firm’s own initiative, by FDA request, or by FDA order. Since 1997, the FDA has banned or restricted distribution of more than a dozen popular drugs. In some cases, widespread use led to the discovery that they could cause severe adverse effects that had not been detected during the research before the FDA approved the drug for marketing. In others, problems arose because doctors ignored safety warnings and prescribed them for patients who did not meet appropriate criteria. Drug recalls are listed at www.recalls.gov. In a 1999 interview, FDA Commissioner Jane Henney, M.D., advised consumers that if a doctor wishes to switch them to a newly marketed drug, they should ask how it is different and indicate that just being new is not sufficient reason.15
counterFeit Drugs
The FDA has expressed concern about a rise in the num- ber and sophistication of drug counterfeiting operations. Since 2000, the agency has investigated more than 20 per year, a sharp increase from an average of 5 per year
—Text continued on page 358
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6 Historical Perspective
The “Evolution” of Patent Medicines
Patent medicines were also known as nostrums and pro- prietary medicines. Nostrums are remedies recommended by their preparers without scientific proof of effectiveness. Strictly speaking, patent medicines are those for which patents have been obtained from the U.S. Patent Office to deter other manufacturers from copying them. (A patent permits a monopoly for at least 17 years.) However, many products referred to as “patent remedies” were actually not patented. A proprietary medicine is one whose name, composition, or manufacturing process is protected from use by competitors. Thousands of patent medicines were produced and distributed in the United States, with sales reaching their peak during the 19th century and part of the 20th century. The 19th century has been called the “patent medicine era” because of the extensive variety of materials sold to the public. Toxic substances could be legally marketed. Some products were said to be for specific ailments, whereas others were supposedly cure-alls. They were claimed to affect afflictions such as “female weakness,” “worn-out kidneys,” yellow fever, goiter, cancer, paralysis, and “piles” (hemorrhoids). Tonics, bitters, and other sub- stances were widely used, but their ingredients were kept secret. The worse a product tasted, the greater its curative powers were assumed to be. Many of the products were neither helpful nor toxic, but some were as hazardous as the ministrations of the doctors practicing “heroic” medicine of the period. Whiskey was considered the all-purpose remedy on the frontier. It was used as an antiseptic, painkiller, and courage builder. Tonics and cough medicines were popular because of their alcoholic content, as illustrated by these products: Hood’s Sarsaparilla (18%), Hotstetter’s Bitters (44%), and Parker’s Tonics (42%). Most hard liquors today are about 40% to 45% alcohol. The home-remedy books of this era promoted pat- ent medicines as well. These volumes included Indian Doctor’s Dispensatory, Dr. John Williams’ Last Legacy, A Useful Family Herbal, Dr. Chase’s Recipes, Gunn’s Do- mestic Medicine, and Poor Man’s Friend in Pain and Sick- ness. Most patent remedies had ingredients derived from the leaves, flowers, seeds, bark, and roots of plants. Notable Promoters and Remedies In 1796 Samuel H.P. Lee, a doctor from Windham, Con- necticut, became the first American to prepare a patent medicine, which he called Bilious Pills. The ingredients were gamboge, aloe, soap, and nitrate of potassium. The pills supposedly would cure biliousness (indigestion attrib- uted to too much bile production), yellow fever, jaundice, dysentery, dropsy (edema), worms, and female complaints. The patent medicine business was very lucrative.
Thomas W. Dyott, king of America’s nostrum makers, marketed products that contained large amounts of alcohol. He assumed the title of M.D. and fabricated experience as a doctor. By 1830 his income was $25,000 per year, which was a fortune at that time. During the early 1800s Samuel Thomson, a New Hampshire farmer, devised a treatment system intended to make people their own physicians. He believed that the diminished “power of heat” and water caused an imbal- ance of body elements. The cure was to restore heat with a 30-minute steam bath, which was followed by washing the body with cold water, taking a powerful vomitive con- taining herbs mixed in brandy, drinking warm water until vomiting occurred, taking another bath, resting in bed, and taking two herbal enemas.16 This treatment was repeated for several days. Thomson was labeled “the sweating and steaming doctor.” The idea of cleaning out the patient’s system and strengthening the patient with tonics was common to both orthodox and folk medicine at that time and is still common among nonscientific practitioners and products today. Lydia E. Pinkham’s Vegetable Compound was advertised in 1873 for female weaknesses, irregular menstruation, inflammation, and ulceration of the womb. The Bureau of Investigation of the American Medical As- sociation could find no medical evidence to support these claims. The compound originally contained 18% alcohol. Eventually vitamins and minerals were added and the alcohol content was reduced. The company appealed to women disenchanted with their doctors by suggesting that the grandmotherly Mrs. Pinkham was compassionate and understood their needs. The Pinkham Guide for Women, a publication important to the product’s success, had over 1 million copies distributed. In 1890 Dr. Samuel Brubaker Hartman produced Pe- runa, which he claimed could cure catarrh (mucus buildup) of the lungs; disorders of the stomach, head, kidneys, blad- der, and pelvis; and other conditions. Peruna contained 25% alcohol. For 25 years no other patent medicine in the United States devoted as much newspaper space to testimonials. Rampant Narcotic Use Brecher17 described 19th-century America as a “dope fiend’s paradise.” Opium was sold legally at low prices. Morphine was commonly used, and heroin was marketed toward the end of the century. These opiate (narcotic) drugs could be purchased as easily as aspirin is today. Physicians dispensed them in prescriptions, drugstores sold them over the counter, grocery and general stores made them available, and they could be ordered by mail. More than 600 patent medicines and other products
Chapter Seventeen Drug Products 357
6
The “Evolution” of Patent Medicines — Cont’d.
contained opium. They were widely advertised in news- papers and on billboards as effective against pain, cough, and other problems. Physicians prescribed them for pain, cough, diarrhea, and other illnesses for which they actu- ally were effective. Opiates were also used as a substitute for alcohol. They apparently helped to calm rather than excite the baser passions and hence were considered less conducive to violent or criminal behavior. Many physi- cians converted alcoholics into narcotic addicts because morphine addiction was thought to be far less damaging than chronic alcoholism. During the Civil War, men who had been injured in battle were given large doses of opium to ease their pain. Soldiers often left hospitals cured of their wounds but addicted to opiates. This affliction acquired the name “soldier’s sickness.” However, addiction was more wide- spread among civilians. Federal narcotics laws passed after the turn of the century ended the inclusion of opiates in nonprescription remedies (see Chapter 25).
Marketing Strategies Advertising played an important role in the patent medi- cine business. By 1860 there were 4000 newspapers, in- cluding 400 dailies. By 1900 there were 100 magazines in production. In 1804 about 100 patent medicines were marketed. By 1858 more than 1500 were advertised, not only in newspapers and magazines but also on handbills, buildings, steamboat decks, and the surfaces of rocks. During the 19th century no laws controlled advertis- ing, and product claims by manufacturers were never modest. The main advertising techniques included:
• Making the product’s name memorable: Burdock’s Blood Bitters, Swift’s Sure Specific.
• Distributing books and pamphlets giving medical advice.
• Using cures from afar (e.g., China, Turkey). • Stating that a product was a powerful remedy used by
the American Indians. • Invoking mythology (Hygeia, the Minerva pill for
syphilis). • Indicating that diseases may cause pain and death. • Using biblical quotations and testimonials from
ministers. • Using testimonials from supposedly satisfied cus-
tomers. Some of these people later died from the disease the medicine was supposed to have cured.
• Using a doctor’s name or picture on the label. • Distributing free items such as an almanac or booklet;
offering a money-back “guarantee.”
During this period, patent medicine promoters often
met their customers face-to-face. They went to towns and villages, especially during fairs, setting up platforms, putting on shows, delivering spiels, selling their wares, and then moving on. The performances evolved into full evenings of drama, vaudeville, musical comedy, bands, parades, and other spectacles. This was all considered re- spectable, as were the sidewalk exhibits in store windows that lured young men to “free exhibits” inside, where they were terrified into believing they suffered from some strange disease. The men were then spirited into examining rooms, where “doctors” asked a few hasty questions and pressured them into buying secret remedies. Often the cost was the exact amount of money found in their wallets. Perhaps the greatest spectacle of the day was produced by John A. Healy and Charles Bigelow and their Kickapoo Indian Medicine Company.18 The entertainment consisted of Indians and Wild West performers who were profes- sional actors. Healy’s “liver pads” supposedly contained a mixture of roots, bark, gum, leaves, oils, and berries prepared by the Kickapoo Indians. Actually they contained sawdust, red pepper, and glue. Dudley J. LeBlanc, a Louisiana state senator, in- troduced Hadacol to the public in 1943. It was an elixir containing 12% alcohol, B-vitamins, iron, calcium and phosphorus, diluted hydrochloric acid, and honey. An 8- oz bottle sold for $1.25, and a 24-oz bottle cost $3.50. A pamphlet entitled “Good Health—Life’s Greatest Bless- ing,” produced by LeBlanc in 1948, contained testimonials by people supposedly cured of conditions such as anemia, arthritis, asthma, diabetes, epilepsy, heart trouble, and high and low blood pressure. It was also claimed that a 13-year-old boy who lacked the energy to ride his bicycle took Hadacol and became a center on his football team. LeBlanc revived the old-time medicine show. In 1950 a caravan of 130 vehicles, including steam calliopes, toured 3800 miles through the South. LeBlanc’s medicine troupe played one-night stands in 18 cities with an average of 10,000 people attending. Hadacol boxtops were accept- ed as admission to hear a Dixieland band play “Hadacol Boogie” and “Who Put the Pep in Grandma?” In August 1951, shortly after LeBlanc claimed sales of $75 million, he sold his business for $8 million plus a $100,000-a-year salary as sales manager. The new owners, however, soon filed for bankruptcy, charging that LeBlanc had concealed $2 million in unpaid debts and grossly inflated the amount owed from previous sales. The broad reach of medicine shows has given way to the even broader reach of radio and television. The spectacular productions have given way to talk shows and infomercials, and the products have been replaced by a myriad of questionable vitamin products, herbs, homeopathics, and exotic “dietary supplements.”
Historical Perspective
Part Five Other Products and Services358
through the late 1990s. Increasingly, these investigations have found well-organized criminal operations seeking to introduce finished drug products that may closely resemble legitimate drugs yet contain only inactive ingredients, incorrect ingredients, improper dosages, or subpotent or superpotent ingredients, or that may be con- taminated. In 2004 the agency issued a comprehensive report19 outlining the problem and steps to combat it.
internet PharMacY sales
Many Web sites sell prescription products directly to the lay public. Although these outlets may enable consumers to save money, it should not be assumed that prices are actually lower. In 1999 Bloom and Ian- nacone20 located 46 Web sites, 37 of which required a prescription or online physician consultation and 9 (located outside of the United States) that did not. The investigation also found that the two most commonly offered medications, Viagra (for impotence) and Propecia (for hair growth) cost 10% more than they did at five Philadelphia phar- macies. On the other hand, comparison shopping, par- ticularly for expensive drugs, may result in significant savings. Most online pharmacies operating in the United States are either established national chain pharmacies (or companies that have agreements to dispense through those pharmacies) or sites that offer only a limited number of “lifestyle” or “popular” prescription drugs. Many Web sites offer online consultations and do not require an original prescription. These sites are usually more expensive than local pharmacies and may not be staffed by competent practitioners. PharmacyChecker. com has noted that companies of this type may operate sites under many different names. The National Association of Boards of Pharmacy has developed a voluntary Verified Internet Pharmacy Practice Sites (VIPPS) program. To earn the right to display the VIPPS logo, companies must be appropriately licensed and have written policies and procedures for drug utilization review, patient counseling, patient confidentiality, and quality improvement programs.
Buying from companies outside of the United States may be risky because the quality of the medications may not meet U.S. manufacturing standards. However, several reputable companies operate from Canada and Israel. The Consumer Tip box offers additional warnings and tips for buying drugs online.
®
Buying Drug Products Online
√ Consumer Tip
Online pharmacies may offer lower prices, privacy, convenience, and access to more generic drugs. On the other hand, companies can be unlicensed, fail to protect your personal and financial information, and/ or dispense drugs that are inappropriate or dangerous. The following strategies can help to protect you.
Precautions • Purchasing from an illegal Web site is risky. You
may receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product.
• Getting a prescription drug by filling out a question- naire without seeing a doctor poses serious health risks. A questionnaire does not provide sufficient information for a health-care professional to deter- mine if that drug is for you or safe to use, if another treatment is more appropriate, or if you have an underlying medical condition for which using that drug may be harmful.
• Don’t buy from sites that offer to sell prescription drugs without a prescription.
• Don’t do business with sites that have no access to a registered pharmacist to answer questions.
• Avoid sites that do not identify with whom you are dealing and do not provide a U.S. address and phone number to contact if there’s a problem.
• Prices can change quickly. Temporary lowball prices are common to attract new customers.
• Look for privacy and security policies that are easy to find and understand. Don’t provide any personally identifiable information (Social Security number, credit card, and health history) unless you are con- fident that the site will protect it. Make sure the site does not share your information with others without your permission.
Helpful Resources • The National Association of Boards of Phar-
macy (www.nabp.net or 847-698-6227) can advise whether a Web site is a licensed pharmacy in good standing.
• Pharmacy Checker (www.pharmacychecker.com) provides general information, prices, price alerts, and customer-satisfaction ratings for Internet-based pharmacies located in the United States and several other countries.
• The FDA, which strongly discourages the purchase of drugs from foreign countries, provides advice, warnings, and news that is indexed from www.fda. gov/buyonline.
Chapter Seventeen Drug Products 359
over-the-counter Drugs
OTC drugs are those obtainable without a prescription. They frequently provide temporary relief from simple discomforts. They can relieve minor complaints when used properly but can cause many problems when used improperly. They include acne products, antacid prod- ucts, antimicrobials, antiperspirants, analgesics, corn and callus removers, cough and cold remedies, menstrual products, laxatives, ophthalmics, skin protectants, anti- smoking products, and sunscreen products. About 1500 active ingredients are used in the more than 300,000 OTC products marketed today. The Consumer Healthcare Products Association (CHPA),21 formerly called the Nonprescription Drug Manufacturers Association (NDMA), estimates that in 2010 Americans spent more than $17 billion for OTC products. The average cost of an OTC product is about $5. A 2001 Roper Starch22 survey of 1500 households found that 77% said they had used an OTC drug at least once during the previous 6 months. The most common problems were headache (81% of people who reported headaches said they had used an OTC product); cough, cold, flu, or sore throat (72%); skin problems (68%); and heartburn (66%). For many people the chief source of information
about OTC drugs is television advertising. Advertise- ments generally are poor sources of drug information. Their message is often deliberately unclear and mislead- ing (see Chapter 4). Their primary purpose is to increase sales of the product, even if this involves inappropriate or unnecessary use.
Labeling Federal law requires that the following information be placed in a “Drug Facts” box23 on all OTC labels in this order:
• The product’s active ingredients, including the amount in each dosage unit.
• The purpose of the medication. • The uses (indications) for the drug. • Specific warnings, including when the product should not
be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist. The warnings section also describes side effects that could occur and substances or activities to avoid.
• Dosage instructions addressing when, how, and how often to take the medication.
• The product’s inactive ingredients, which are relevant to some people with allergies.
Figure 17-3 provides an example.
Drug Facts Active Ingredient (in each tablet) Purpose Chlorpheniramine maleate 2 mg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antihistamine
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itchy throat
Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema of chronic bronchitis trouble urinating due to an enlarged prostate
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives
When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions adults and children 12 years and over
children 6 years to under 12 years
children under 6 years
Other Information store at 20–25º C (68–77º F) protect from excessive moisture
Inactive Ingredients D&C yellow no. 10. lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch
take 2 tablets every 4 to 6 hours; not more than 12 tablets in 24 hours
take 1 tablet every 4 to 6 hours; not more than 6 tablets in 24 hours
ask a doctor
Figure 17-3. Sample “Drug Facts” box
Part Five Other Products and Services360
Suggestions for Using OTC Medicines Before purchasing an OTC drug, be certain that you have a rational use in mind, and consider whether a physician should be seen instead. Products should be selected according to their ingredients rather than ad- vertising claims. The best way to choose OTC drugs is to use a reference book or Web site (with professional guidance if needed) to identify the chemical names of the ingredients that are most useful for the condition in question and check product labels to obtain what you need. A pharmacist can help select a suitable product. Before using any OTC drug, learn about its purposes, side effects, recommended dosage, precautions for use, and limitations. Directions for use will be found on the product label or an accompanying instruction sheet. Generally these directions are accurate and conservative. Medicines should not be taken in higher dosage or more frequently than indicated unless specified by a physician. Many OTC products contain more than one active ingredient. Single ingredients products are usually better because they enable consumers to identify the lowest ef- fective dose of one drug that is capable of relieving the distress they feel. This can be done only if the ingredients are available separately. Moreover, it may be advisable to adjust the dosage of one ingredient more than another. Some combination products include questionable ingre- dients, which makes them potentially less safe and at best
no better than the effective ingredient(s) alone. Thus it is generally best to select single-ingredient products. People who take several combination products that contain the same ingredient may get too much of that ingredient. The FDA24 has warned, for example, that the widespread presence of acetaminophen in products for pain, fever, coughs, and colds can lead people who take several such products to risk liver damage by exceeding the current maximum daily dosage of 4000 mg. This warning is important because the margin of safety (dif- ference between therapeutic and toxic dosage) is narrow.
external analgesics
External analgesics are lotions, creams, liniments, and gels that are topical (applied to the skin) and have an- algesic, anesthetic, antipruritic (anti-itch), or counterir- ritant effects. The analgesic, anesthetic, and antipruritic substances depress skin receptors for pain, itching, and burning and act directly to reduce or obliterate symptoms resulting from burns, cuts, abrasions, insect bites, and other lesions. Topical counterirritants are applied to the intact skin for the relief of pain. Their effect results from irritation of the skin that draws attention away from other sources of discomfort. Equally effective relief may be obtainable by applying heat with a warm compress, hot water bottle, hot shower, or other means.
Historical Perspective
FDA’s OTC Drug Review
In 1972 the FDA began an extensive evaluation to ensure the effectiveness and safety of over-the-counter drugs. Rather than attempting to evaluate each of the huge number of products, it divided the ingredients into cat- egories and appointed expert advisory panels to evaluate the categories.25
The panel phase of the review spanned about 10 years and covered 722 ingredients, some of which fell into more than one category.26 The advisory panels concluded that only one-third of these ingredients were safe and effective. As a result, manufacturers reformulated many products by removing unsafe and ineffective ingredients or by adding others. Many other unapproved ingredients were banned by the FDA. All of remaining ingredients are now covered by final or tentative final rules and are considered by the FDA to be safe and effective.27. The advisory panels also recommended shifting a number of active ingredients from prescription to OTC status. Since 1976 about 80 ingredients, dosages, or in- dications have been switched from prescription to OTC status. These include certain antihistamines and nasal
decongestants for colds and allergies, sleep aids, pain relievers, cough medicines, antimicrobial products, and anti-itch medicines. Examples are sodium and stannous fluoride rinse (anticaries), chlorpheniramine maleate (antihistamine), hydrocortisone (topical antiinflammatory drug), low-dose ibuprofen (pain reliever), oxymetazoline hydrochloride (topical nasal decongestant), loperamide (for diarrhea), and the antifungal drugs clotrimazole and miconazole nitrate (for fungal infections of the skin and vagina). Today’s OTC marketplace differs remarkably from that of a century or two ago—or even 15 years ago! Ex- cept for homeopathics, the vast majority of OTC drugs are backed by scientific evidence that they are safe and effective for their intended purposes. Ironically, as this transformation took place, the U.S. Congress weakened the laws governing the sale of herbs, vitamins, minerals, amino acids, and other substances marketed as “dietary supplements” (see Chapters 11 and 25). As a result, the marketplace has been flooded with dubious nondrug products.
Chapter Seventeen Drug Products 361
Counterirritants produce a mild inflammatory reac- tion. Some products bring extra blood to the surface of the skin by dilating the small blood vessels, thus warming the area; the heat supposedly provides pain relief. The extra blood flow may also speed removal of lactic acid and other substances that contribute to local discomfort. The use of counterirritants has a strong psychologic component and may exert a placebo effect. However, they can cause contact dermatitis (inflammation) in in- dividuals with sensitive skin. The most common active ingredients are methyl salicylate (the active substance in oil of wintergreen), menthol, camphor, and capsaicin (a red pepper derivative). Several precautions should be considered in us- ing these counterirritants: (a) do not use when there is severely restricted blood circulation in the legs; (b) do not bandage the area, since the skin may blister; (c) to prevent irritations, do not bring the preparations in con- tact with the eyes; (d) do not apply to wounds or broken skin; (e) do not apply to large parts of the body; (f) do not use to mask the discomfort of a serious injury; and (g) discontinue use if an adverse reaction occurs.
internal analgesics
Internal analgesics are used for pain relief but have other uses as well. The most significant OTC ingredi- ents are aspirin, acetaminophen, ibuprofen, ketoprofen, and naproxen sodium. These substances are generally safe when used as directed but cause adverse reactions in some people. Table 17-3 summarizes their potential benefits, dosage, adverse effects, and cost. Most pain-relief products contain an appropriate amount of one of these ingredients. A few contain both aspirin and acetaminophen, even though such combina- tions have no proven advantage. Several products con- tain caffeine, which may enhance the effect of aspirin or acetaminophen on certain types of pain but can produce nervousness as a side effect. Some include an antacid ingredient that may lessen the incidence of stomach upset from an occasional dose. However, taking a full glass of water or other liquid with each dose can accomplish this also.
Aspirin Aspirin (acetylsalicylic acid) is effective against pain, fever, and inflammation. The adult dose of two 5-grain tablets (325 mg each) provides substantial relief from mild to moderate pain. Aspirin risks include the following:
Hypersensitivity: Allergic reactions include asthma, hives, eczema, other rashes, and (rarely) anaphylactic shock. Gastrointestinal disturbances with internal bleed- ing: Approximately 5% of the individuals who take one dose complain of heartburn and dyspepsia. The incidence of gastroduodenal bleeding is high, but the amount of blood loss is usually not clinically significant. Ototoxicity: Large doses of aspirin (9 to 25 tablets, 325 mg each) can cause ringing in ears, dizziness, and bilateral hearing loss. The conditions generally disappear within a few days after use of the drug is stopped. Prothrombin depression: Aspirin can reduce plasma prothrombin (involved in blood coagulation) levels and increase the time it takes blood to clot. No one taking anticoagulants should take aspirin without close medical supervision. Overdose: A dose of 25 to 35 low-dose aspirins (81 mg each) can kill a child 1 to 5 years of age. Signs of overdose include bloody urine, diarrhea, dizziness, severe drowsiness, and ringing and buzzing in the ears. However, although small children have mistaken fla- vored aspirin for candy, childproof packaging has almost eliminated aspirin poisoning in this age group. Reye’s syndrome: Aspirin taken by children or teenagers who have a viral illness can cause Reye’s syndrome, a disease that is rare but can be fatal. There- fore, aspirin should not be administered to children or teenagers who have or may have a viral illness. Pregnancy: Large amounts during the latter months of pregnancy can cause adverse effects for both mother and fetus. More than 3250 mg/day (10 adult tablets) can delay or prolong labor, cause greater blood loss at deliv- ery, increase perinatal mortality, and decrease neonatal birth weight. Low doses of aspirin (a) can help prevent heart attacks and strokes among individuals who have previ- ously suffered such events, (b) can save the life of heart attack victims if taken within hours after the onset of an attack, (c) may prevent an initial heart attack if taken by apparently healthy people with no history of heart disease, (d) may prevent serious complications from high blood pressure during pregnancy, (e) may lessen the frequency of migraine headaches, and (f) may reduce the risk of developing colon cancer. However, none of these uses should be attempted without discussion with a physician. Adding alkaline buffers makes aspirin dissolve more quickly, speeding its absorption into the system. This reduces but does not eliminate the effect of aspirin on
Part Five Other Products and Services362
the stomach. However, there is little or no appreciable difference in the onset of clinical effects. Enteric-coated tablets, which are treated so they do not dissolve until they reach the intestine, cause less stomach irritation. They may benefit those who are ar- thritic and take aspirin regularly, but the onset of relief is not as prompt. Acetaminophen Acetaminophen—the ingredient found in Tylenol—is as effective as aspirin in relieving pain and reducing fever. However, it has little antiinflammatory effect. Therefore it should not be relied on for treating inflammatory ar- thritis or other types of inflammation. Acetaminophen
has four advantages over aspirin: (1) it can be used by people allergic to aspirin, (2) it does not cause gastric mucosal damage and bleeding, (3) it is less apt to affect anticoagulant therapy, and (4) it is not associated with Reye’s syndrome in children. Its disadvantages resulting from excessive ingestion are kidney damage and liver toxicity, primarily in heavy drinkers. Ibuprofen, Naproxen, and Ketoprofen Ibuprofen, naproxen, and ketoprofen are nonsteroidal antiinflammatory drugs (NSAIDs) that are available in higher dosage as prescription drugs. Like aspirin, all offer pain relief and fever reduction in addition to anti- inflammatory action. Ibuprofen is the active ingredient
coMParison oF otc Pain relievers
Table 17-3
Common brand names
Therapeutic uses
Appropriate amount per tablet
Usual adult dosage*
Relative cost Advantages
Adverse effects
Acetaminophen
Anacin-3 Datril Tylenol
Pain relief Fever reduction
325 mg
2 tablets every 4–6 hours; 4000 mg daily limit
$$
Fewer side effects than aspirin
Stomach upset, but less than aspirin
Some risk of kid- ney disease with prolonged daily use
Aspirin
Bayer Bufferin Empirin Norwich
Pain relief Fever reduction Antiinflammatory effect in higher
doses (requires medical super- vision)
Heart attack prevention with small doses (requires medical supervision)
325 mg
2 tablets every 4–6 hours
$
Lowest cost
Stomach irritation Interferes with blood clotting Allergic reactions, ranging from
itching to asthma Ringing in ears (very high doses) Should never be given to children
younger that 16 years who have a viral illness.
Other NSAIDs
Ibuprofen: Advil, Medipren, Motrin IB, Nuprin, Pamprin-IB
Ketoprofen: Actron, Orudis-KT Naproxen sodium: Aleve
Pain relief Fever reduction Menstrual pain relief Dental pain relief Soft tissue injury pain relief Antiinflammatory effect in higher doses
(requires medical supervision)
Ibuprofen: 200 mg Ketoprofen: 12.5 mg Naproxen: 220 mg
Ibuprofen: 2 or 3 tablets every 6 hours Ketoprofen: 1 or 2 tablets every 4–6 hours Naproxen: 1 or 2 tablets every 12 hours
$$$
Fewer side effects than aspirin; antiinflammatory doses better tolerated
Stomach upset (ibuprofen in between as- pirin and acetaminophen; naproxen and ketoprofen have higher incidence)
High doses can cause bleeding and per- foration of the stomach; cardiovascular complications are rare
*The NSAID dosages are based on general medical knowledge. The upper range of frequency is slightly higher than product labels suggest for initial use.
Chapter Seventeen Drug Products 363
in the prescription form of Motrin, which is used for the treatment of arthritis and menstrual pain. The pre- scription versions of naproxen and ketoprofen include Naprosyn and Orudis, respectively. NSAIDs can cause troublesome and potentially serious side effects if taken in high doses or for prolonged periods.28 The most frequent is gastrointestinal irritation, including heartburn, nausea, constipation, or diarrhea. Taking an NSAID with food reduces the chance of stomach irritation. The serious risks include perforation of the stomach lining and a small increase in heart attacks and strokes. These are unlikely to occur with OTC dosage, but it appears prudent to administer the lowest possible dose for the shortest possible duration. NSAID products are also available for topical use in the form of a gel, cream, or spray that is applied in the region where musculoskeletal pain is experienced. They are typically used for strains or sprains, rather than headache or abdominal pain. The resultant blood concentrations are much lower than those produced by oral NSAIDs, which reduces the risk of serious harm.29 Advertisements for some OTC pain relievers have suggested that they are more powerful than others on a milligram-for-milligram basis. Consumer Reports on Health30 called this comparison meaningless because “People take pills, not milligrams. So what if one active ingredient requires fewer milligrams to have the same
effect as another?” The article also stated that naproxen and ketoprofen are not more effective than ibuprofen and should be considered only as a fallback to ibuprofen. The Medical Letter31 has noted that alcohol ingestion may increase the risk of liver damage or gastrointesti- nal bleeding caused by NSAIDs or acetaminophen, but the risk with small amounts of alcohol is unknown. It recommends that people who drink regularly should use analgesics infrequently and at the lowest possible doses.
Costs An effective dose of an oral OTC pain reliever can cost anywhere from 2¢ up to about 30¢. Generic products are generally less expensive than brand-name products. The cheapest pain reliever will usually do the job. Brands with similar amounts of the same ingredients should do the job equally well. Higher-than-usual doses are usu- ally unnecessary unless pain is severe, but severe pain is often a reason to consult a physician. “Extra-strength” products, which contain higher dos- es per tablet, are more expensive than regular-strength products and are unnecessary. An individual wishing to take more than the regular dose can easily use regular- strength tablets to do so. For example, someone wishing to take 1000 mg of acetaminophen may save money by using three 325-mg tablets instead of two 500-mg “extra-strength” tablets.
Historical Perspective
Revolutionary Treatment for Peptic Ulcers In the early 1980s two Australian physicians (Barry Mar- shall and Robin Warren) theorized that the underlying cause of peptic ulcers is a bacterium able to live within the layer of mucus that normally protects the stomach wall.32 The organism was later named Helicobacter pylori. The conventional treatment of ulcers had been guided by findings made during the 1960s, when it was assumed that surplus stomach acid was the cause. The conventional treatment used drugs to suppress acid secretion or antacids to render the acid harmless. Although these cause most ulcers to heal, they do not prevent recurrences. Today most cases can be cured by antibiotics or antibiotics plus bismuth (the active ingredient in Pepto-Bismol). This means it is very important that patients with persistent symptoms of pain, burning, or related symptoms seek a medical diagnosis rather than merely trying to suppress their symptoms with antacids. The American College of Gastroenterology (ACG) has issued guidelines for the diagnosis and treatment of H. pylori infections.33 The presence of the organism can
be determined with a blood test, a breath test, or tests on a specimen obtained by endoscopy (a procedure in which a diagnostic instrument is inserted through the mouth into the patient’s stomach). Most antibiotics used to treat H. pylori should be taken for at least 2 weeks. Stopping treatment too soon can leave behind resistant bacteria that can cause further trouble. Many quackery promoters portray the H. pylori dis- covery as an example of the medical community rejecting new ideas that later turned out to be true —so therefore their own pet ideas should not be dismissed. However, several things are wrong with this portrayal. Marshall and Warren did not behave like quacks. They knew what evidence was needed and did the studies necessary to substantiate their theory. They did not try to sell their treat- ment to the public. Moreover, although there was reason to be skeptical, the theory was sufficiently intriguing to stimulate investigations by others who confirmed that it was correct.34 In 2005, Marshall and Warren received the Nobel Prize in Physiology or Medicine.
Part Five Other Products and Services364
antaciDs anD other heartburn reMeDies
Overeating, eating quickly, or eating certain foods may lead to feelings of fullness, nausea, heartburn, or other symptoms identified as “sour stomach,” “upset stomach,” or indigestion. Individuals seeking relief may reach for an antacid, H2 blocker, or proton pump inhibitor. Antac- ids function by neutralizing the hydrochloric acid present in stomach secretions. Heartburn is usually caused by a reflux of stomach acid into the esophagus. H2 block- ers can prevent symptoms by reducing the production of stomach acid. Proton pump inhibitors (PPIs) block production of a key acid component. Whereas antacids provide rapid relief, H2 blockers take up to an hour and PPIs can take several hours to reduce acid levels. All antacids are safe when used occasionally by healthy individuals. However, if taken on a regular basis they may cause bowel irregularities, aggravate kidney disorders, or mask a serious problem such as a peptic ulcer. Regular use requires medical diagnosis and supervision. Sodium bicarbonate can cause belching, flatulence, and sodium overload (fluid retention). Magnesium compounds can cause diarrhea. Calcium carbonate and aluminum-containing antacid products can cause constipation. Some antacid products combine calcium and magnesium compounds in an attempt to balance the opposing tendencies toward diarrhea and constipation. After testing 16 products, Consumer Reports35 con- cluded that Mylanta Ultra Tabs, Tums Ultra Maximum Strength, Maalox Max Antigas Maximum Strength, Mylanta Extra Strength Calcium, CVS Extra Strength Calcium, and Walgreens Super Strength Calcium all lasted about 2 hours. A prescription-strength H2 blocker or PPI is used to treat severe problems, such as stomach inflammation (gastritis), ulcer, or gastroesophageal reflux disease (GERD). GERD is a cause of heartburn that, if untreated, can lead to esophageal bleeding and other serious com- plications. Lower-dose OTC H2 blockers and PPIs are available for treating heartburn. However, recent studies have found that taking a PPI posed an increased risk of infection with Clostridium difficile (see Consumer Tip box) and fractures in several parts of the body. For this reason, Consumers Union36 advises against using a PPI without a medical evaluation to determine whether it is appropriate. Consumers who use or contemplate use of a heart- burn remedy may find this information helpful:
• Instead of habitually using these products, reduce or elimi- nate the causes of frequent heartburn or upset stomach, such as cigarette smoking, excess fatty food, alcohol, or stress.37
• If lifestyle changes don’t work, try using an inexpensive antacid.
• Liquid or powdered antacids neutralize acid more effec- tively than tablets. Chew tablets thoroughly to help them dissolve or disperse quickly in the stomach. To increase effectiveness, take them 30 minutes to 2 hours after a meal.
• Antacids may interfere with the absorption of tetracyclines, digitalis, anticoagulants, and many other categories of drugs. Consult your pharmacist or doctor before combining medications.
• People on a sodium-restricted diet should avoid antacids that contain sodium.
• Pregnant women and people with ulcers or kidney problems should consult a physician before using any antacid.
• Remember that symptoms similar to “indigestion” or heartburn can be caused by other conditions such as angina, heart attacks, gallstones, and peptic ulcers. It is not neces- sary to see a doctor for occasional heartburn or indigestion. However, a doctor should be seen if symptoms are severe or recur over a week or two.
• Seek medical help immediately if your heartburn is severe and accompanied by chest pain, weakness, breathlessness, or sweating, because these may signify a heart attack.
antiMicrobial Drug ProDucts
Antimicrobials are substances used to fight infections caused by disease-producing microorganisms. They include antibacterials, antivirals, antifungals, and anti- parasitics. Except for a few topical products, they are prescription items and should not be used without the advice of a physician. The most commonly used anti- microbials are antibiotics, which are primarily effective against bacteria. More than 100 antibiotics have been developed. Culture and sensitivity tests may be used to help determine the appropriate drug to prescribe for a patient’s illness. Antibiotics have dramatically reduced the death rates from many diseases and have prevented much suffering. However, they can have serious adverse effects. Because organisms can develop resistance to their effects, they should not be prescribed without appropriate indication. Antibiotics are useless against the viruses that cause colds but may be useful if a secondary bacterial infection occurs.
OTC First-Aid Antimicrobials First-aid antimicrobials are products applied to the skin to help prevent infection in minor cuts, scrapes, and burns. These products should not be used for longer than 1 week or to treat existing infections, animal bites, sunburn, punctures, or cuts that are deep or contain imbedded particles that cannot be flushed away. The FDA has approved several antibiotic and antiseptic
Chapter Seventeen Drug Products 365
ingredients. However, the most important aspects of wound care are stopping bleeding, cleaning out dirt and debris, and applying a clean bandage to prevent further contamination. For most wounds that are suitable for self-treatment, using an antimicrobial product offers no advantage over simply rinsing with water or washing with soap and water to remove surface dirt. Antibiotic treatment, either topical or oral, is ap- propriate in contaminated wounds that have embedded debris, but these should be under medical management. Antiseptics have well-established uses for killing germs on intact skin before cutting or puncturing the skin for
medical procedures. Because they can damage normal cells, their use to try to prevent infections in wounds is controversial.38
Hand Sanitizers An alcohol-based hand sanitizer (Purell) kills most germs on contact. By washing their hands after defeca- tion, people with diarrhea who care for children may prevent the spread of the infection. The product can also be useful for handwashing in situations where water is not available.
cough anD colD reMeDies
Almost any congestion in the nose may be labeled a cold, even though the congestion may be caused by pollutants or allergens rather than by one of the 120 or so viruses that cause cold symptoms. Colds can be classified as abortive (symptoms subside in 24 hours), mild, moderate, and severe. Medical science cannot cure a cold, but several types of medicines can help to control the symptoms. Most coughs are caused by acute respiratory tract infections, such as the common cold. Coughs are usually mild and self-limiting. The cough reflex, controlled by a cough center in the brain, helps the lower respiratory tract rid itself of secretions and foreign matter. Dry, hacking coughs, which are usually caused by irritation rather than secretions, often can be controlled by an OTC medication that suppresses the cough reflex. Productive coughs reflect the body’s need to clear the respiratory passageways of secretions. Coughs that are productive and accompanied by a high fever or that last for more than 1 week indicate a need for medical attention.
OTC Ingredients Americans spend about $4 billion annually for OTC cough, cold, and allergy remedies that contain one or more of the following ingredients. Topical decongestants: Nose drops and inhalants can provide temporary relief from nasal stuffiness. These products produce physiologic effects resembling those caused by the activity or stimulation of the sympathetic nervous system. They work by constricting dilated blood vessels and opening the nasal passages. The substances include phenylephrine and oxymetazoline. Although topical decongestants are more effective than oral decon- gestants, frequent use can cause rebound nasal stuffiness that is worse than the original stuffiness. Oral decongestants: Sympathomimetic amines ingested orally last longer but cause less intense
A Difficult Germ Clostridium difficile can produce toxins that damage the large intestine (colon). The bacterium is carried harm- lessly by about one person in 50 but is more common among patients in hospitals and nursing homes. It is usually held in check by friendly bacteria that inhabit the colon, but when the normal balance is disturbed, it may overgrow. This can happen when any antibiotic is administered but most often occurs with clindamycin, ampicillin, or the cephalosporins. C. difficile overgrowth can result in a mild, self-lim- iting diarrhea; a more severe diarrheal illness (colitis); or a life-threatening disease called pseudomembraneous colitis. The symptoms can range from simple loosening of the stools to relentless bloody diarrhea with fever and severe abdominal pain. They can begin during the period of antibiotic therapy, a few days afterward, or even as long as 6 weeks later. These infections can be expensive and sometimes difficult to diagnose and treat. Hospitalization may be required. Relapses occur in 20% to 40% of cases. The point of this story is that antibiotics are a two- edged sword and should not be taken promiscuously. Intelligent consumers should adhere to four strategies:
• Don’t take antibiotics unless they are prescribed for you.
• Don’t press a doctor to prescribe antibiotics for colds or for other viral infections for which there is no proven benefit.
• If you develop diarrhea while taking an antibiotic, stop taking it and notify your doctor quickly. Fail- ing to do so could result in serious worsening of the diarrhea.
• If you have taken an antibiotic up to 6 weeks before contracting a diarrheal illness, mention this fact when you consult your doctor.
√ Consumer Tip
Part Five Other Products and Services366
vasoconstriction than topical sprays or drops. They do not produce rebound congestion but can produce insom- nia and irritability. The most commonly used ingredients are pseudoephedrine and phenylephrine, which is less effective. Expectorants: Expectorants are administered orally to stimulate the flow of respiratory tract secretions to help with dry coughs. The only currently approved substance is guaifenesin, which has been shown to loosen phlegm but not to help relieve a cough. Oral cough suppressants: Cough suppressants are used for dry, hacking coughs but should not be used for productive coughs. The FDA has approved two ingre- dients as safe and effective for OTC use: dextrometho- rphan and codeine (in combination products only). These ingredients work by inhibiting the brain’s cough reflex. However, many states prohibit the inclusion of codeine in OTC cough suppressants because of the potential for abuse. Codeine as the sole active ingredient is available by prescription.
Dextromethorphan is not very effective and is some- times abused. A study published in 2004 found that it was not better than a placebo in providing relief in children with nighttime cough and sleep difficulty due to an upper respiratory infection.39 In 2008, after the FDA is- sued a public advisory, OTC cough and cold medication manufacturers modified their product labels to state that their products should not be used by children younger than 4 years. Consumers Union40 recommends using hot liquids, a steam vaporizer, and/or nonmedicated throat lozenges instead. Topical cough suppressants: Camphor and menthol can be marketed for use in hot steam vaporizers and in ointments rubbed on the chest. However, there is little objective evidence that they are effective. Fever-reducing pain relievers: In adults 325 to 650 mg (5 to 10 grains: 1 to 2 tablets) of acetaminophen or aspirin or 200 mg of ibuprofen every 4 to 6 hours should help relieve discomfort and fever. Ketoprofen and naproxen have similar properties (see Table 17-3).
Colds
Gradual
5–7 days
Low-grade fever, if any
No
Mild, if any
Mild, if any
Uncommon
No
Yes
Yes
No
Common at onset
Mild to moderate hacking cough
No
Mild to moderate
Nasal Allergies
Very rapid
As long as exposed to allergen
No
No
No
No
No
No
Yes
Yes
Yes
Sometimes
Sometimes
No
No
Onset Duration
Fever Shaking Chills Headache Muscle and joint pains
Fatigue, weakness
Extreme exhaustion Runny, stuffy nose Sneezing Itching of eyes Sore throat Cough
Shortness of breath Chest discomfort
Flu
Rapid
1–2 weeks
Yes, can be high
Yes
Usual
Yes, often severe and widespread
Usual; may last 2–3 weeks after other symptoms have resolved
Yes, early and prominent
Sometimes
Sometimes
No
Sometimes
Yes, can become severe
Sometimes
Yes
how the sYMPtoMs oF inFluenza (Flu) coMPare to those oF nasal allergies anD colDs
Table 17–4
Chapter Seventeen Drug Products 367
Antihistamines: Antihistamines are found in many cold remedies. Despite common beliefs, they have no ability to prevent or abort colds or to relieve cold symp- toms.41 They can also cause drowsiness. Their usefulness in treating allergies is covered in Chapter 14. There is no evidence that vitamin C supplements can prevent the common cold. At best they may slightly reduce symptom duration and severity (see Chapter 11). Vitamin C is not an approved ingredient in OTC products for colds but is promoted as a cold remedy by the dietary supplement industry.
Suggestions for Treatment It has been said, “You can cure a cold with treatment in 1 week and without treatment in 7 days.” The best a person can do about a cold is to get symptomatic relief. These suggestions are worth considering when cold symptoms appear.
• Rest in bed for a day or so, especially if the symptoms are severe.
• For aches and pains, take acetaminophen or ibuprofen. • Decongestant nose drops can provide temporary relief from
a stuffy nose, but symptoms may worsen if they are used too frequently.
• A vaporizer can help relieve a cough by putting moisture into the air and loosening secretions.
• Sucking cough drops or lozenges, increasing fluid intake, and consuming hot beverages or soups may be beneficial. Lozenges and cough drops offer no advantages over less expensive hard candies.
• A physician should be consulted if a cough lasts longer than 1 week.
• Heed package warnings pertaining to adverse interactions with other drugs.
Table 17-4 indicates how the symptoms of influenza (flu) compare to those of nasal allergies (e.g., hay fever) and colds.
sore-throat ProDucts
Lozenges and sprays containing a local anesthetic (ben- zocaine or dyclonine hydrochloride) can temporarily relieve pain. Some products contain a local antiseptic (such as cetylpyridinium chloride or hexylresorcinol) and/or menthol or camphor. Antiseptics have no value because the offending organisms are deep in the throat tissues where the product cannot penetrate. OTC mouthwashes are dilute solutions of aromatic substances that may be sweetened with saccharin and colored. They may contain ethanol, astringents (zinc salts), surface-active agents (for foam), and quaternary
ammonium halides (antiseptic agents). The halides have no significant ability to kill germs during a gargle. Com- parable relief could be obtained from salt water (1/2 tsp of salt to an 8-oz glass of warm water). An oral pain reliever might help to relieve general discomfort. Untreated throat infections caused by streptococci may lead to rheumatic fever or kidney disease. If a sore throat lasts more than a day or two or is accompanied by fever or severe malaise, a physician should be consulted to assess the likelihood of a streptococcal infection.
oPhthalMic ProDucts
Nonprescription ophthalmic products are basically safe and effective only to relieve minor symptoms such as itching, tearing, tired eyes, dry eyes, or redness caused by minor irritation of the eyes. These problems are usually self-limiting. OTC products may cause allergic reactions due to the active ingredients or preservatives. The FDA requires that OTC products for the relief of eye symptoms carry the warning: “If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.” Eyewashes must carry the same warning but without the 72-hour limit on use. Smarting, burning, itching, conjunctivitis, and blepharitis (inflammation of the eyelid) are often caused by infection by bacteria or viruses, or by allergic sensi- tivity to dust, pollens, and molds. These generally can be relieved fairly quickly with warm compresses and/or medication prescribed by a physician. Eye fatigue may result from errors of refraction (nearsightedness, farsightedness, and astigmatism), or it may be associated with general fatigue caused by a sleep- less night, for example. There are also some systemic conditions that affect eye muscles and lids and cause fatigue. However, these conditions are not suitable for OTC treatment but require medical aid. Should a simple eye irritation occur from smog, strong light, sea bathing, or swimming in chlorinated water, placing one or two drops of cold tap water on the lower lid with a clean eye dropper is generally help- ful. The application of iced, wet compresses for about 15 minutes safely relieves tired but otherwise healthy eyes. Boric acid solutions have not been demonstrated to be more effective than plain water for the relief of eye discomfort. A stye is an eyelid infection caused by Staphy- lococcus bacteria. The symptoms are a red, swollen, tender area and some pain. The condition is usually
Part Five Other Products and Services368
self-limiting, but if it persists or worsens, a physician should be consulted. Warm compresses can provide temporary relief and speed the healing process. An ophthalmic antibacterial ointment may be useful. (This requires a prescription.)
Diarrhea reMeDies
Most attacks of diarrhea are self-limiting; the symptoms are relieved within a day or two, with or without treat- ment. However, if the symptoms do not subside after a brief time, or if they are accompanied by fever, severe abdominal pain, severe malaise, or bloody stools, a physician should be consulted. Replacement of lost fluid is important in patients with diarrhea. To help maintain fluid and electrolyte bal- ance, ingest caffeine-free beverages and salted crackers. Alcoholic beverages should be avoided. For children with diarrhea, electrolyte maintenance fluids, such as Pedialyte, are available. However, they are expensive and doctors can advise how to make a suitable substitute. Two main types of ingredients are used in diarrhea remedies: adsorbents and antiperistaltic agents. Adsor- bents attract and hold fluid so that the bowel movements become less watery. Antiperistaltic agents help stop diar- rhea by slowing down the motility of the intestine. The adsorbent approved for OTC use for mild to moderate acute diarrhea is bismuth subsalicylate (in Kaopectate and Pepto-Bismol). The antiperistaltic ingredient in OTC products is loperamide, which is available in Imodium A-D and several other brands. Traveler’s diarrhea occurs as a result of consuming food or water that contains unfriendly bacteria. It can often be prevented if these simple rules are followed while traveling abroad: do not eat anything that is not cooked, except for fruit that you peel yourself; do not eat salads; do not drink beverages with ice in them; do not brush your teeth with water that you would not consider safe to drink; and drink only bottled water, soft drinks, yogurt, beer, or wine. The basic rule is “boil it, cook it, peel it, or forget it.” Bismuth subsalicylate (Pepto-Bismol) is somewhat effective for preventing and treating traveler’s diarrhea. The preventive dose is 30 to 60 ml or 2 tablets four times each day during the first 2 weeks of travel. For acute illness, 30 to 60 ml can be taken every 30 minutes for a total of eight doses. The salicylate content of this prod- uct can be a problem for people who are taking other salicylate-containing drugs (if the combined total is too high) or who are allergic to aspirin.
anti-heMorrhoiDals
Hemorrhoids are clusters of dilated (varicose) veins in the lower rectum and anus; they generally occur between 30 and 50 years of age. External hemorrhoids are located under the skin around the anus. Internal hemorrhoids develop in the lower rectum. Internal hemorrhoids may prolapse (protrude) through the anus. Most prolapsed hemorrhoids shrink back inside the rectum on their own. Severely prolapsed hemorrhoids may protrude perma- nently and require treatment. Internal hemorrhoids are rarely painful, but external hemorrhoids can be. Hemorrhoids are frequently self-treatable. They may be related to lack of sufficient dietary fiber, insufficient fluid intake, overuse of laxatives, chronic constipation, pregnancy, and lifting heavy objects. Some symptoms that lead people to believe they have hemorrhoids may be caused by a different problem that requires medical attention. Itching can be the result of poor anal hygiene, perianal warts, intestinal worms, medication allergies, psoriasis, or nervous scratching; and bleeding can be caused by cancers and several other types of serious medical problems. Simple diet and lifestyle changes often reduce the swelling of hemorrhoids and relieve hemorrhoid symp- toms.42 Eating a high-fiber diet can make stools softer and easier to pass, reducing the pressure on hemorrhoids caused by straining. A doctor may suggest a stool soft- ener such as psyllium (Metamucil). Other measures that may help relieve hemorrhoid symptoms include increas- ing fluid intake, sitz baths (sitting in a tub of warm water for 10 minutes several times a day), exercising to prevent constipation, and not straining during bowel movements. The area around the anus should be kept clean and dry. Residual fecal matter would keep the area moist and can irritate the skin, but vigorous wiping with dry toilet paper can make things worse. Instead, swab after each bowel movement using unscented toilet paper moistened with warm water or a premoistened wipe. Then gently pat the area dry. A general-purpose, water-based oint- ment such as K-Y Jelly may help protect the skin after it is cleaned. OTC anti-hemorrhoidal products that contain an- esthetic, astringent, and/or counterirritant ingredients may lessen symptoms but can make irritations worse. Hydrocortisone in some products is an effective anti- itch ingredient, but its overuse can lead to dependency and cause thinning of the skin. For that reason, OTC anti-hemorrhoidal products should not be used without medical advice.
Chapter Seventeen Drug Products 369
If hemorrhoid symptoms persist for a week or two despite self-treatment, a doctor should be consulted. In some cases, a minimally invasive outpatient procedure such as rubber band ligation will be appropriate. In se- vere cases, surgical removal (hemorrhoidectomy) may be necessary to stop the bleeding.
laxatives
Constipation (hard stools) is a functional impairment of the colon, which normally produces properly formed stools at regular intervals. Constipation is related to an individual’s habits and can occur when the customary pattern of bowel action is disrupted. The most common cause is too little fiber in the diet. Various medications have constipation among their side effects. Some people believe that the colon is like an un- sanitary sewer and requires vigorous, periodic cleaning. Many quacks have thrived by promoting this notion (see Historical Perspective box on Autointoxication Theo- rists.) There is no scientific support for this idea. Nor is it necessary to have a daily bowel movement. Some people normally have a bowel movement only once ev- ery two or three days. Others do so only once per week,
although this is not common and need not be encouraged. After limited irregularity, bowel rhythm usually returns to regular action with no treatment; there should be no ill effects except a slight feeling of discomfort. If it fails to return after 1 week, a physician could be consulted. Temporary bowel changes can result from travel, change of diet, emotional tension, or a side effect of medication. In such cases, if consumption of additional fruits, vegetables, fluids, and high-fiber foods is not successful, a prepackaged saline enema or glycerin sup- pository is generally the quickest and safest approach. Properly administered, an enema cleans only the distal colon and has an effect similar to that of a normal bowel movement. Increasing exercise can also help. Consumer Reports on Health43 recommends that if these measures do not work, use of a bulk-forming agent or stool softener should be the next step. If that does not work, a volume-forming laxative for a day or two may be advisable. However, overdependence on laxatives can be harmful; they should not be used on a regular basis. Table 17-5 compares various types. Pain in the abdomen can be caused by a variety of conditions. Some, including an inflamed appendix, a bowel obstruction, or certain cancers, are serious and
Many faddists have claimed that the “bowels” (in- testines) are a major source of health problems. One unfounded theory (“autointoxication”) suggests that intestinal sluggishness leads to the absorption of poisons; another suggests that fecal material collects on the lining of the intestine and causes trouble unless removed by laxatives or enemas. The concept of enemas may have originated from observations of the ibis, a bird that was thought to use its curved beak to give itself a rectal infusion of Nile water. The ancient Egyptians gave enemas with beer, oil, or other fluids, adding such ingredients as honey, herbs, hemp, or ox brain. Enemas were used to “resist poison,” to nourish weak and consumptive patients (using wine), to prevail against dropsy (using urine), and to exorcise devils from possessed nuns (using holy water). In 18th- century England tobacco enemas were used to attempt to resuscitate drowned persons. In the United States in the 1930s children were often subjected to colonic ir- rigation for all sorts of complaints. Today various fringe practitioners still advocate colonics and other measures to “detoxify” the body (see Chapter 8).
Historical Perspective
Autointoxication Theorists Elie Metchnikoff, a Russian chemist who won the 1908 Nobel Prize for his contributions to immunology, was a strong proponent of yogurt. His 1907 book, The Prolongation of Life, described his search for the elixir of life and his discovery of Bulgarians who supposedly lived to the age of 100. He concluded that the sour milk (yogurt) they consumed was the cause of this extended life. Metchnikoff claimed that putrefaction of proteins in the intestines released poisons that caused disease. He called this “auto-intoxic action” and said that yogurt drove out the poisons by supplying microorganisms that were gentle, friendly, and happy. Dr. John Harvey Kellogg, who had advocated an immaculate bowel, capitalized on Metchnikoff’s theory and changed his treatment at Battle Creek. He did not permit putrescible foods and “disinfected” all fruit with chemicals. Patients would have the “poisons” flushed out of the alimentary canal by taking half a pint of whey culture by mouth and injecting another half pint into the colon by enema. Kellogg was probably more responsible than anyone else for the common belief that a daily bowel movement is necessary.
Part Five Other Products and Services370
require skilled medical assistance. The use of laxatives in such cases is dangerous. A laxative should not be used when nausea or vomiting is present or for longer than 1 week. Overuse suppresses the normal urge to defecate and leads to dependency. Rectal bleeding or failure to have a bowel movement after the use of a laxative may indicate a serious condition and is reason to consult a physician. The following self-help measures can help prevent constipation:
• Eat a well-balanced diet that includes whole-grain breads or cereals; prunes or prune juice; fresh fruits; and vegetables.
• Drink adequate amounts of liquids. • Exercise regularly. • Set aside time for an undisturbed visit to the toilet. • When possible, defecate fairly soon after feeling the urge
to do so.
sMoKing Deterrents
Much of the difficulty people have in quitting smoking is caused by nicotine withdrawal symptoms. Within 24 hours of stopping, about 80% of smokers experience withdrawal symptoms that can include a craving for nicotine, irritability, anxiety, difficulty in concentrating, restlessness, and difficulty with appetite (either too much or too little). Nicotine-replacement therapy is intended to make the transition from smoker to nonsmoker easier. The FDA has approved five forms of nicotine re- placement therapy—gum, inhaler, lozenge, nasal spray, and patch—for treating nicotine dependence. These products can help the smoker break the behavioral habits of smoking without suffering the discomforts of nicotine withdrawal at the same time. After a few months, their use is tapered off. The results are best if the prescribing
coMParison oF otc laxative ingreDients
Table 17-5
Type Bulk-
forming agents
Lubri- cants
Stool softeners
Volume- forming laxatives
Chemical stimu- lants
Examples
Bran, cellulose, methylcellulose polycarbophil, psyllium
Mineral oil
Docusate
Magnesium salts, sorbitol, sulfate salts
Bisacodyl, casan- thranol, cascara, senna, castor oil
Products
FiberCon, Metamucil, Serutan
Agoral Plain, Fleet Mineral Oil Enema
Colace, Dialose, Regutol, Surfak
Citrate of Magnesia, Epsom Salts, milk of magnesia
Carter’s Little Pills, Castor Oil, Dulco- lax, Ex-Lax, Feen- A-Mint, Fletcher’s Castoria, Modane
Mechanism of Action Absorb water in the intestine
and swell the stool into an easily passed soft mass.
“Grease” stools to facilitate excretion.
Merge with feces to soften their consistency. Use- ful for people who are temporarily bedridden; have hard, dry stools; or must avoid straining. Not effective for chronic constipation.
Promote secretion of water into the intestine.
Promote secretion of water into the intestine; some stimulate more vigorous contractions of the colon. Should be considered a last resort.
Comments
Safe to take indefinitely
Should be used only sparingly and for short periods; can interfere with absorption of fat- soluble vitamins and can leak from rectum
Should be used only sparingly and for short periods
Relatively safe, but pro- longed use promotes dependency
Can lead to dependency and can damage the bowel with daily use for months or years; can dangerously deplete potassium
Chapter Seventeen Drug Products 371
physician is familiar with smoking-cessation techniques and provides appropriate counseling.44,45 The prescription drugs Zyban (bupropion) and Chantix (varencline) have also been approved for this purpose. Clonidine and nortriptyline are also effective in helping some smokers quit. The FDA has not approved them for this purpose, but has approved them for other uses. Chapter 14 has additional information about smok- ing cessation.
stiMulants For Fatigue
Fatigue is a normal physiologic result of physical exer- tion and usually disappears after adequate rest. However, students who want to avoid fatigue and stay awake while cramming for exams, truck drivers taking long trips, and others seeking greater alertness for another reason may resort to OTC drugs or illegally obtained prescription drugs that contain a stimulating substance. The ingredient in the OTC products is caffeine. It can help reduce drowsiness and fatigue and stimulate muscular function. An FDA advisory panel said, “In cases where mental alertness or motor performance is necessary, such drugs (caffeine) can modify fatigue states
to allow successful completion of a required task.”47 The FDA panel stated that caffeine in doses of 100 to 200 mg every 3 to 4 hours is safe and effective in OTC products. Table 17-6 illustrates the caffeine contents of selected sources. Some OTC pain relievers contain as much as 64 mg of caffeine per dose, the amount in half a cup of coffee. The inclusion of caffeine in product mixtures for relief of headache is questionable. Too much caffeine can cause several problems. It can mask fatigue to the point where a person may sud- denly collapse from exhaustion. It may make a person excessively nervous and irritable, cause palpitations and heart irregularity, and stimulate excess stomach acidity. Habitual users may require increasing amounts of caffeine to feel stimulated. Some individuals will experience withdrawal symptoms (headache, irritability, restlessness, and fatigue) if they suddenly stop a daily regimen of coffee consumption.
sleeP aiDs
OTC sleep aids rely on an antihistamine for their seda- tive effect. They contain either diphenhydramine (used in Nytol and Sominex) or doxylamine succinate (used in Unisom) as their sole active ingredient. Their sedation effects vary from individual to individual. Occasional use of a sleep aid is not harmful, but a person with a chronic sleep problem should consult a physician. Prescription sleep aids are far more potent than nonprescription products and can have more sig- nificant side effects. Two prescription drugs—Lunesta and Roserem—are FDA-approved for long-term use but are considerably more expensive than other sleep aids. None of the older prescription drugs should be used for long periods of time. Alcohol has sedative qualities, but, if used on a regular basis, the quantity may have to be continually increased to induce sleep. In addition, the user may awaken in the middle of the night when the sedative ef- fect wears off. A warm glass of milk is safer and might work. Consumers Union46 recommends trying cognitive behavioral therapy with a therapist who helps establish behaviors conducive to sleep. A common but frequently unsuspected cause of insomnia is the consumption of caffeine-containing beverages such as coffee, tea, chocolate, and various soft drinks. Caffeine can interfere with sleep even when ingested during the early part of the day. Insomnia for more than 3 weeks may warrant an extensive diagnostic evaluation. The “Self-Help for Sleepless Nights” box suggests measures that can help restore a normal sleep pattern.
Source Beverages
Brewed coffee* Instant coffee* Tea* Decaffeinated coffee “Energy drinks” Other soft drinks
(read the label) Cocoa Milk chocolate
OTC products
Caffedrine capsules Nodoz Extra Strength Vivarin Nodoz tablets Excedrin Extra
Strength Anacin, Cope
caFFeine content oF selecteD sources
Table 17-6
Caffeine (typical amount)
60 to 125 mg/cup 40 to 80 mg/cup 50 to 70 mg/cup 2 to 4 mg/cup
70 to 300 mg/16 oz 30 to 55 mg/12 oz
25 mg/cup 3 to 6 mg/oz
200 mg 200 mg 200 mg 100 mg 65 mg
32 mg
*The amount of caffeine in coffee and tea varies with the brand, the size of the cup, and the strength of the brew. A cup is 6 fluid ounces.
Part Five Other Products and Services372
Motion sicKness reMeDies
The FDA has approved four ingredients for use in OTC motion sickness drugs: cyclizine, meclizine, dimenhy- drinate, and diphenhydramine. The most common one is dimenhydrinate, which is used in Dramamine and most other products. These drugs are antihistamines that can cause drowsiness and should not be combined with alcoholic beverages. Transderm Scop, a prescription product for adults, can prevent motion sickness without causing sedation. The product is a patch that is placed behind the ear of the user at least 4 hours before its effect is desired. The patch releases small amounts of scopolamine over a 3-day period.
iron-containing ProDucts
A well-balanced diet usually supplies enough iron, even for most women with heavy menstrual periods. The body normally absorbs the correct amount of iron that it needs. However, some people are prone to iron overload (hemo- chromatosis), which can cause serious damage to body organs. Iron supplements can also cause constipation. It is inadvisable to take iron-containing supplements without first determining whether they are needed.
Government action has put an end to the once- commonplace pitches “for people with tired blood” (see Historical Perspective box on page 55). However, advertisements that exaggerate the difficulty of getting enough dietary iron still occur. Although severe anemia can cause fatigue, only a small percentage of people with fatigue or lack of energy have anemia. Moreover, if someone is anemic, iron tab- lets by themselves may not solve the problem. Anemia is a condition in which there are not enough red blood cells. The causes include iron deficiency, abnormal absorption of vitamin B12, liver and thyroid diseases, hidden infec- tions, and internal bleeding within the gastrointestinal tract. Tests are necessary to make an accurate diagnosis, and the treatment should attempt to correct the cause. Supplementary iron may be appropriate for a limited period when anemia is caused by a dietary deficiency, but dietary iron intake should be increased to prevent future difficulty. (The best sources are liver, red meats, and poultry.) Consumer Reports48 has estimated that only 6% of women between 18 and 44 are iron-deficient due to heavy menstrual-blood losses. Iron-containing products are packaged in blister packs to reduce inadvertent overdosage by children. However, they should still be stored carefully if there
• Cut back on caffeine consumption, particularly in late afternoon or evening.
• Don’t drink alcohol before bedtime. Although alcohol may help people fall asleep, it tends to wake them up a few hours later when its sedative effects wear off.
• Before bedtime, take a warm shower or, better yet, a warm bath.
• Retire to an environment conducive to sleep; use bed- ding that’s comfortable, and be sure the bedroom is quiet and dark.
• Stick to a regular sleep schedule throughout the week and avoid daytime napping or oversleeping on week- ends.
• When anxiety is a problem, set aside a time during the day as a regular worry period; meanwhile, be mentally armed with a list of pleasant, relaxing subjects to crowd out anxieties at bedtime—and try not to worry about going to sleep.
√ Consumer Tip
Self-Help for Sleepless Nights Self-help and traditional remedies may be sufficient to cope with occasional bouts of insomnia. Before reaching for drugs, insomniacs may want to try one or more of these measures:
• Regular exercise can help, but avoid exercising within a couple of hours of bedtime.
• Avoid excitement before retiring. Relax with light read- ing, restful music, or television.
• Don’t eat large meals before bedtime. Instead, eat a light snack high in carbohydrates.
• Try sleep restriction, a strategy based on the finding that many insomniacs spend too much time in bed, hoping to make up for lost sleep: Go to bed later than usual, and get up at the same time each morning. Stay in bed only as long as you actually sleep, even if it is only for a few hours. When you sleep at least 90% of your allotted time in bed for 5 days in a row, go to bed 15 minutes earlier. After a week or two you should be sleeping better and, after a few months, as long as you want. This method is generally easier when done under knowledgeable professional supervision.
Chapter Seventeen Drug Products 373
are children in the home, because an overdose can be fatal.49
hoMe MeDicine cabinet
It is prudent to have medical supplies and drug products available for self-treatment of certain illnesses, injuries, and emergency situations. Select from Table 17-7 ac- cording to the anticipated needs of your household. Drugs should be stored where they will not be exposed to excess humidity. Keep drug items out of reach of children. Periodi- cally review and discard medications that have reached their expiration date or have changed in color, odor, or consistency. The telephone numbers of your doctor, hospital, poison control center, ambulance or rescue squad, and police and fire emergency switchboards should be kept handy.
PruDent use oF MeDication
Safe, effective drug use depends on the patient’s under- standing of the drug regimen, its risks and benefits, and the necessary precautions associated with each medica- tion. In many cases, the key to safe and effective use of medication is open communication with the prescriber. Prudent use of medication requires knowledge of the following: • The name of the drug. Knowing the name will not only
enable you to look up information about the drug, it will also enable you to discuss it with your doctor (or another doctor) should this be necessary.
• The drug’s purpose. This information will help you under- stand your treatment and whether it is working.
• How and when should it be taken? This basic information will be on the product’s label. Some medications are best taken on an empty stomach (before meals) for maximum absorption. Some are best taken on a full stomach to prevent
hoMe MeDicine cabinet
Table 17–7
First-Aid and Medical Supplies Adhesive bandages of various sizes Absorbent cotton ACE bandage Tongue depressors Ice pack (blue-gel pack kept in freezer) Sunscreen product Flashlight Dosage spoon Fine-point tweezers and sewing needle (for removing
splinters)
Drug Items Aspirin, acetaminophen, and/or ibuprofen Antacid Hydrocortisone ointment or cream Antibiotic ointment or cream Antidiarrhetic (bismuth subsalicylate) Antihistamine (chlorpheniramine) Cough syrup Decongestant (oxymetazoline) Antinausea (dimenhydrinate) Mild laxative (milk of magnesia) Glycerine suppositories or prepackaged enemas Calamine lotion Pediatric acetaminophen, pediatric ibuprofen
Hydrogen peroxide (for cleansing wounds)* Sterile gauze pads Adhesive tape Cotton-tipped applicators Hot water bottle or heating pad Safety pins Small, blunt-edged scissors Thermometers Petroleum jelly First-aid manual
For Treatment of Fever, headache, other aches and pains Heartburn and upset stomach Minor skin irritations, allergies, insect bites Minor contaminated skin wounds and infections Diarrhea Allergic reactions and colds To reduce the intensity of a cough Stuffy nose Nausea (including motion sickness) Occasional constipation Occasional constipation Contact dermatitis (e.g., poison ivy) Fever in a child
*The best way to clean most wounds is to wash with soap and water. However, hydrogen peroxide may also be useful for this purpose.
Part Five Other Products and Services374
the medications from irritating the stomach. Some are in- activated by food and must be taken on an empty stomach. Some have to be taken on an exact schedule, while others do not. It is helpful to keep a written record of what you are doing—particularly when several medications are being taken on different schedules. If you miss a dose, consult your doctor or pharmacist.
• Are there any special instructions? Sometimes specific foods, alcoholic beverages, or other medicines will react unfavorably with the medicine just prescribed.
• What side effects might occur? All drugs have possible side effects. If they occur, in some cases nothing needs to be done and the medication can be continued. In others, a change of dosage or medication will be advised. The oc- currence of certain adverse reactions would be a reason to stop using the drug. It can help to know the common ones and what to do if they occur. One of the most important side effects is drowsiness—which is common with anti- histamines, sedatives, and drugs for mental and emotional problems. People taking any of these drugs should not drive a car until they have determined that the drugs will not in- terfere with their ability to do so safely. Information about adverse effects can be obtained by asking your physician or pharmacist or consulting a reliable reference.
• What should I do if I miss a dose? In some cases it will be advisable to make up the dose to maintain an adequate blood level of a medication. In other cases it will not matter, and doubling the dose will increase the likelihood of side effects.
• How long should the drug be taken? Some drugs need to be taken only until symptoms stop, while others should be taken for a period specified in advance. For example, pain relievers can be stopped when your pain goes away, but antibiotics are typically prescribed for a specific period of time to eradicate germs that remain even though symptoms of the infection have disappeared.
• Is a generic form available? Generic drugs usually cost less and are just as potent as name-brand drugs. Some doctors routinely prescribe them, but others either think they are inferior or simply just don’t bother. With a few medicines for serious diseases there may be a medical reason to avoid a generic drug. But in most cases there is no reason they cannot be used.
It should not be necessary to ask all the aforemen- tioned questions each time you visit a doctor and receive a prescription. A good doctor will communicate most of this information when the medicine is prescribed. But do not expect or demand a lengthy discussion on the uncommon side effects and complications of common drugs. If you think your doctor is not communicating enough, a tactful question may lead to clarification. Table 17-8 includes several excellent information sources for consumers. Some doctors and pharmacies provide instruction sheets on common prescription drugs. A package insert should be provided by the pharmacist who fills the
recoMMenDeD anD nonrecoMMenDeD Drug reFerences
Table 17-8
Recommended Sources Consumer Drug Reference 2009
Consumer Reports Best Buy Drugs
FDA Consumer Drug Information
MEDLINEplus Drug Information from U.S. Pharmacopeial Convention
Physician’s Desk Reference, 2012, up- dated annually
Nonrecommended Sources Handbook of Nonprescription Drugs,
2009, updated every 2-4 years
PDR for Nonprescription Drugs and Supplements, 2006
Description
Consumer Report’s detailed compilation of the purposes and side effects of more than 11,000 brand-name prescription and OTC drug products.
Monographs on cost-effective drug options for common medical problems (www.bestbuydrugs.org).
Patient information sheets on uses and safety considerations for about 550 drugs (www.fda.gov/cder/drug/drugsafety/drugindex.htm).
Excellent database of 9000 prescription and OTC drugs (www.nlm.nih.gov/medlineplus/druginformation.html).
Although accurate, the PDR is written for physicians and is impractical for laypersons because it provides little perspective on the frequency of side effects and what to do if they occur.
Written for pharmacists. Three entire chapters and parts of other chapters contain untrustworthy information on “complementary and alternative medicines.”
Written by manufacturers. Some entries provide reliable, easy-to-read material; others do not. Supplement information tends to be overly promotional.
Chapter Seventeen Drug Products 375
prescription, but Consumer Reports50 has found that these sometimes fail to include or call attention to fed- erally mandated warnings that are required for certain drugs. Various types of aids can help people take their medications properly. These include medication calen- dars, individual instruction sheets, color-coded bottles, blister cards, calendar trays, self-sealing plastic bags on which the dates and times for medicating are written, special bottlecaps that record when bottles are opened, and bottlecaps and boxes that beep or buzz when it is time to take a dose. When traveling, try to take along enough medicine to meet your anticipated needs and keep your medi- cines with you. Do not place them in checked luggage. Carrying extra amounts may be wise in case a flight is cancelled or your trip is delayed. You should also carry copies or a list of your prescriptions. Many pharmacies will print them out for you. If a childproof container is hard to handle, ask the pharmacist for one that is easy to open.
Safety Precautions The following suggestions may help you use medica- tions safely.
• If you go to more than one doctor, tell each about any prescription and OTC medications and herbal products
you are taking. It is a good idea to keep a record with you. Also tell the doctor about any adverse drug reaction you have had.
• Stick to the prescribed dosage. Taking extra may increase the chances of adverse reactions without increasing the chances of benefit. And don’t stop a medicine because you don’t think it is working. Some drugs must be taken for several days or even weeks before their effect is apparent. Instead, contact your doctor for instructions.
• Keep a daily record of all drugs being taken, especially if treatment schedules are complicated.
• Remember that alcohol and sedatives can multiply each other’s effect on the brain. Don’t mix alcohol and sleeping pills, antianxiety agents, or any other drugs that have seda- tive effects. If you drink regularly, make sure your doctor knows about it.
• Keep your drugs in their original containers so no mix-up occurs about which drug is which.
• Clean out your medicine cabinet periodically. Drugs that have reached their expiration date or have changed in color, odor, or texture can be returned to a pharmacy for proper disposal. Drugs prescribed for a previous illness or for another person should not be taken without first checking with the physician. The drug may have lost its strength or changed its composition, or a more appropriate drug may be available for the illness.
• Call your doctor promptly if you suspect that an adverse drug reaction is occurring.
• Consider purchasing all of your prescription products at a pharmacy with a computer that tracks them and alerts the pharmacist to possible adverse drug interactions. This might have protective value if your physician overlooks a significant interaction. However, this potential benefit should be weighed against the advantage of comparison shopping to save money.
• Remember that it may be risky to share medicines with others. When prescribing medications, doctors take into account the patient’s age, weight, gender, other medications being taken, and other factors. What is good for one person may not be good for someone else.
• Dispose of unused medications safely (see Consumer Tip box).
Cost-Saving Strategies Although the total amount Americans spend on drug products is only a small percentage of total health-care costs, the proportion spent out of pocket is high (see Chapter 24). Several strategies can lead to savings on drug costs. Many people can save significant sums by asking their doctors to consider cost when choosing which drugs to prescribe and to give preference to generic drugs when possible. Higher-priced drugs are not necessarily better than low-priced drugs. If a product seems espe- cially expensive, ask whether a less costly alternative is
Guidelines for Drug Disposal51
The FDA advises that most unused drugs can be thrown in the household trash, but certain precautions should be taken.
• Follow any specific disposal instructions on the drug label or patient information that accompanies the medication.
• Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so.
• Take advantage of community drug take-back pro- grams that allow the public to bring unused drugs to a central location for proper disposal.
• If no instructions are given on the drug label and no take-back program is available in your area, throw the drugs in the household trash, but first take them out of their containers, mix them with an unpalatable substance, and put them in a plastic bag or other leak- proof container.
• To protect your privacy, remove all identifying infor- mation from drug containers before discarding them.
√ Consumer Tip
Part Five Other Products and Services376
available. This is often the case with antibiotics. Some of the newer antibiotics are very expensive. Although they may be important for certain infections, most infections can be managed with older, less expensive antibiotics. Many legitimate foreign pharmacies sell brand-name drugs online for less than their cost within the United States. The FDA advises against buying from foreign pharmacies, but it can be done safely by using the in- formation at www.pharmacychecker.com. Costco, CVS, Kmart, Kroger, Safeway, Target, Walmart, and many other supermarkets sell hundreds of generic drugs for $10 to $20 for a 3-month supply, which for some drugs is less than 10% of the cost of brand-name counterparts. For nonprescription drugs it is wise to learn the names, dosages, and purposes of common active ingredi- ents and list those that seem useful for the self-treatment of minor ailments. This information will make it possible to choose the least expensive products that contain the desired ingredients. As with prescription drugs, prices vary from product to product and from store to store. Information about ingredients in specific products can be obtained from product labels, package inserts, a pharmacist, or Web sites operated by reliable pharmacies such as Drugstore.com (www.drugstore.com). People who require prescribed medication for a long-term illness may find it economical to purchase pills in large quantities. Consumers who can wait 1 week or longer to obtain a drug may find that mail-order or Internet-based pharmacies offer savings on many drugs. Pill-splitting is another strategy. Many prescription drugs are available at increased dosages for the same or similar costs as smaller dosages. If higher-strength pills can be split to achieve the desired dosage, up to half of the cost of some medications may be saved.52 Pills that are scored are easily divided. Others may be amenable to
cutting with an inexpensive device. However, sustained- or controlled-release drugs should not be split because splitting might cause too-rapid absorption. Many pharmacies give 10% discounts to senior citizens, and several states have passed laws that reduce prescription drug costs for the low-income elderly. Price should not be the sole reason for selecting one’s phar- macy, however. Convenience, courtesy, and service may be worth the extra price paid for a product. A pharmacist may be able to help you assess the quality of products and should be willing to answer questions readily. Some insurance plans that cover prescription drugs reduce the out-of-pocket cost when they are purchased online. Some Medicare beneficiaries can save money by enrolling in a Medicare plan that includes prescription drug coverage (see Chapter 23). The Partnership for Prescription Assistance Web site (www.pparx.org) provides information about free and low-cost prescription drugs for people who meet certain financial criteria.
suMMarY
The two basic types of medicines that can be purchased in the United States are prescription and nonprescrip- tion drugs. The vast majority of nonprescription drugs are over-the-counter (OTC) drugs that consumers can select as they wish. Prescription drugs generally are more powerful and have more side effects. Prudent consumers learn the name, purpose, dosage, side effects, and other significant characteristics of drugs that are prescribed for them. This information can be obtained from one’s physician, a pharmacist, product labels, package inserts, and drug reference books. OTC drugs are intended mainly for self-treatment of minor illnesses and injuries. Since 1972, expert advisory
Your doctor has prescribed an antibiotic for a respiratory tract infection. On the second day you took the drug, you develop nausea and diarrhea. Which of the following actions would you take? Reason
Consult the Physician’s Desk Reference to see whether this is a common side effect. _______________________ Telephone your doctor to report the new symptom. _______________________ Wait 24 hours to see what happens. _______________________ Stop taking the drug. _______________________ Telephone the pharmacist. _______________________ Other (specify) _________________________________ _______________________
It’s Your Decision
Chapter Seventeen Drug Products 377
panels have reviewed the ingredients in these products to determine their safety and efficacy. As a result, most ingredients that were hazardous or ineffective have been removed from the marketplace. Many potent drug ingredients that were available only by prescription 35 years ago are now available over the counter. However, at most pharmacies, the offerings also include dietary supplements, herbs, and homeopathic products that have no rational use—and many pharmacists do not provide trustworthy advice about these products. The commonly used OTC products include pain relievers, antacids, cough and cold remedies, laxatives, and remedies for diarrhea and motion sickness. The best way to choose most OTC remedies is to determine what ingredients are desirable and select products that contain them. In most cases, single-ingredient products are best. It is also prudent to have medical supplies and drug products available at home for the self-treatment of minor illnesses and injuries and for first aid. Generic drugs usually are equivalent to brand-name drugs and usually are less expensive. Prudent comparison shopping can save money, but sources should be carefully checked.
reFerences
1. Legal requirements for the sale and purchase of drug products containing pseudoephedrine, ephedrine, and phenylpropanolamine. FDA Web site, May 8, 2006.
2. Singer N. Drug firms apply brand to generics. The New York Times, Feb 15, 2010.
3. Barrett S. Ignorant and unethical behavior of pharmacists. Quackwatch Web site, July 19, 2011.
4. Pray SW. Ethical, scientific, and educational concerns with un- proven medications. American Journal of Pharmaceutical Educa- tion 70(6), article 141, 2006.
5. Nelson MV and others. A survey of pharmacists’ recommendations for food supplements in the U.S.A. and the U.K. Journal of Clinical Pharmacy and Therapeutics 15:131–139, 1990.
6. Harris IM and others. Attitudes toward complementary and alter- native medicine among pharmacy faculty and students. American Journal of Pharmaceutical Education 70(6):1-7, 2006.
7. Bouts BA. The misuse of compounding by pharmacists. Quackwatch Web site, Nov 26, 2005.
8. The special risks of pharmacy compounding. FDA consumer update, May 31, 2007.
9. Cramer JA and others. How often is medication taken as prescribed? A novel assessment technique. JAMA 261:3273–3277, 1989.
10. Nightingale SL, Morrison JC. Generic drugs and the prescribing physician. JAMA 258:1200–1204, 1987.
11. Myths and facts of generic drugs. FDA Consumer 21(7):13–14, 1987.
12. Meadows M. Preventing serious drug reactions. FDA Consumer 38(4):12–17, 2004.
13. When alcohol and drugs don’t mix. Consumer Reports 70(3):6, 2005.
14. Avoiding drug interactions. FDA Web site, July 24, 2011.
15. Neergaard L. Drug bans blamed on doctors who ignored safety warnings: FDA says death resulted from patients using new medi- cines. Associated Press, Dec 12, 2000.
16. Whorton JC. Traditions of folk medicine in America. JAMA 257:1632–1635, 1987.
17. Brecher EM and the editors of Consumer Reports. Licit and Illicit Drugs. Boston, 1972, Little, Brown & Co.
18. McNamara B. Step Right Up. Garden City, N.J., 1976, Doubleday & Co.
19. Combating Counterfeit Drugs. Rockville, Md., 2004, Food and Drug Administration.
20. Bloom BS, Iannacone RC. Internet availability of prescription pharmaceuticals to the public. Annals of Internal Medicine 131:830–833, 1999.
21. OTC sales by category—2007–2010. Consumer Healthcare Prod- ucts Association Web site, accessed July 1, 2011.
22. Self-care in the New Millennium: American Attitudes Toward Maintaining Personal Health and Treatment. New York, 2001, Roper Starch Worldwide.
23. New OTC Drug Facts label. FDA Consumer 36(4):35, 2002. 24. FDA limits acetaminophen in prescription combination products;
requires liver toxicity warnings. FDA news release, Jan 13, 2011. 25. Young JH. Self-Dosage Medicines: An Historical Perspective.
Lawrence, Kans., 1974, Coronado Press. 26. Gilbertson WE. FDA’s review of OTC drugs. In Handbook of
Nonprescription Drugs, ed 10. Washington, D.C., 1993, American Pharmaceutical Association.
27. Your Health at Hand Book: Guide to Active Ingredients in the United States. Washington, D.C., 2010, Consumer Healthcare Products Association.
28. Dean L. Comparing NSAIDS. PubMedHealth Web site, May 1, 2011.
29. Massey T and others. Topical NSAIDs for acute pain in adults. Cochrane Database of Systematic Reviews DOI: 1002/14651858. CD007402.pub2, 2010.
30. What’s the best pain reliever? Depends on your pain. Consumer Reports 61:62–63, 1994.
31. Acetaminophen, NSAIDs, and alcohol. The Medical Letter on Drugs and Therapeutics 38:55–56, 1996.
32. Lewis R. Surprise cause of gastritis revolutionizes ulcer treatment. FDA Consumer 28(10):15, 1994.
33. Chey WD and others. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. American Journal of Gastroenterology 102:1808–1825, 2007.
34. Atwood KC IV. Bacteria, ulcers, and ostracism? H. pylori and the making of a myth. Consumer Health Sourcebook Web site, Oct 17, 2005.
35. Heartburn: Picking the right remedy. Consumer Reports 76(9):42– 45, 2002.
36. When it comes to heartburn drugs, less may be more. Consumer- ReportsHealth.org, May 11, 2010.
37. Gastroesophageal reflux disease. PubMed Health Web site, Dec 12, 2010.
38. Atiyeh BA and others. Wound cleansing, topical antiseptics and wound healing. International Wound Journal 6:420–430, 2009.
39. Paul IM and others. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics 114:e85–e90, 2004.
40. Dangerous drugs: Top 10 news reports of 2010. Consumer Reports Best Buy Drugs Web site, Dec 2010.
41. Sutter AI and others. Antihistamines for the common cold. Co- chrane Database Systematic Reviews 7(4):CD001267, 2009.
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42. Hemorrhoids. National Digestive Diseases Information Clearing- house Web site, Nov 20, 2010.
43. Laxatives. Consumer Reports on Health 2:85, 1990. 44. Dunston A. Kicking Butts in the Twenty-First Century: What
Modern Science Has Learned about Smoking Cessation. New York, 2003, American Council on Science and Health.
45. Fiore MC and others. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD, 2008, U.S. Department of Health and Human Services. Public Health Service.
46. Evaluating newer sedative drugs used to treat insomnia: Comparing effectiveness, safety, and price. Consumer Report Best Buy Drugs report, 2008.
47. Siegel M. Help for the sleepless. FDA Consumer 28(7):14–17, 1994. 48. Iron in the diet: Do you need supplements? Consumer Reports
61(3):6–7, 1996. 49. Hinglet AT. Preventing childhood poisoning. FDA Consumer
30(2):7–11, 1996. 50. Key drug warnings falling through cracks: No federal monitoring
of drug labels; What consumers can do to stay safe. Consumer Reports Health press release, June 28, 2011.
51. Disposal of unused medicines: What you should know. FDA Web site, March, 2010.
52. Stafford RS and others. The potential of pill splitting to achieve cost savings. American Journal of Managed Care 8:706–712, 2002.
Chapter Eighteen
Skin Care and image enhanCement
For every beauty dilemma, there’s a product that’s claimed to solve it. But many don’t, and lots of us have been suckered into buying stuff that doesn’t work.
ShopSmart magazine1
To think that a moisturizer with herbs, vitamins, botanicals, or some other skin care ingredient can feed the skin, is like thinking that you can put a bologna sandwich on your face and have lunch.
paula Begoun2
For things that are clearly image-threatening or stigmatizing, fix them—cleft palate, buck teeth, severe acne, big stick-out ears. If your nose is really badly deformed, fine. Other than that, the more maturity, the better. . . . If you want to give your kid something when they graduate from high school, give them a book, not breasts.
arthur Caplan, ph.D.3
Man can be cured of every folly but vanity. Jean-JaCqueS rouSSeau (1712–1778)
© medical economics, 1996
“Who’s been into my Rogaine?”
Part Five Other Products and Services380
A mericans spend many billions of dollars a year for pills, powders, creams, potions, and proce- dures that they hope will make them look better.
The American Academy of Dermatology states that the average American adult uses at least seven skin-care products a day.4 Drugstore News5 has reported that in 2010 Americans spent $36.5 billion for cosmetics and toiletries. The American Society of Plastic Surgeons6 states that 13.1 million cosmetic and 5.3 reconstructive plastic surgery procedures were performed in 2010. Consumer Reports7 estimated that nearly 30 million Americans would visit a tanning salon in 2005. This chapter discusses cosmetics, soaps and hand cleansers, moisturizers, hair products, sun protection, insect repel- lents, cosmetic surgery, tattooing, body piercing, and several other types of products and services related to personal appearance and skin care.
CoSmetiC regulation
The federal Food, Drug, and Cosmetic Act defines cosmetics as “articles (other than soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.” The FDA has classified cosmetics into 13 categories: skin-care products (creams, lotions, powders, and sprays); fragrances; eye makeup; other makeup (lipstick, foundation, and blush); manicure products; hair color- ing preparations; deodorants; shaving products; baby products (shampoos, lotions, and powders); bath oils and bubble baths; mouthwashes; sunscreens; and shampoos,
permanent waves, and other hair products.8
Cosmetic product labels must list all ingredients that compose more than 1% of a product (by weight), in the order of predominance, with the ingredient pres- ent in the largest amount first. This enables individuals with allergies and sensitivities to avoid problematic ingredients and can help people compare differently priced products. The International Cosmetic Ingredient Dictionary, which is available at many public libraries, provides definitions, trade names, and other information about more than widely used 5000 ingredients. Cosmetics marketed with claims that they can affect structure or function must meet the labeling standards for drugs in addition to those of cosmetics. Such prod- ucts include dandruff shampoos, fluoride toothpastes to prevent dental decay, and sunscreen and sun-blocking cosmetics. Dual-classification products must be proven safe and effective for their therapeutic claims before marketing. Color additives also require FDA approval. Under the FDA’s good manufacturing practice guidelines, even cosmetic products that are not regu- lated as drugs should be tested for safety and subject to quality control during manufacture. FDA review of the tests is not necessary, but safety warnings are required if problems become apparent. The products that require warnings include products in pressurized containers (potentially dangerous to children), detergent bubble bath products (may irritate the skin or urinary tract), genital deodorant sprays (may cause irritation or al- lergic reaction), hair-dye products that contain coal-tar dyes (can irritate skin), chemical depilatories and hair straighteners (alkaline ingredients can cause burns),
• Many ingredients in cosmetic products are included for marketing purposes and serve no useful purpose. Price is not a reliable measure of quality.
• Antiperspirants and deodorants have been oversold. Bathing is by far the most important body-odor control measure.
• By masking tiny lines, some moisturizing agents may help the skin look and feel better for a few hours.
• Some products and procedures can reduce fine wrinkles and age spots, but no cosmetic product can prevent or eliminate wrinkles, repair sun-damaged skin, or retard or reverse the aging process of the skin.
• The main causes of premature skin aging are (a) excessive ultraviolet light exposure and (b) cigarette smoking.
• Effective over-the-counter and prescription products are available to treat acne.
• People contemplating cosmetic surgery should think carefully about why they want it, thoroughly investigate the credentials of a prospective surgeon, and gather realistic information about the limitations and possible adverse ef- fects of the procedure.
keep theSe pointS in mind aS You StudY thiS Chapter
Key Concepts
Chapter Eighteen Skin Care and Image Enhancement 381
shampoos and conditioners (can irritate eyes), and nail builders (can irritate skin).9
SoapS and CleanSerS
Soaps are traditionally made of natural ingredients: fatty acids from animal fat or vegetable oils, alkalis, scents, and coloring materials. Solid soaps are made from so- dium alkalis, such as lye, whereas liquid soaps are based on potassium alkalis. Most bar soaps are inexpensive, but some marketed for their scent or other aesthetic feature are priced quite high. Low-priced bar soaps usually cost less than low-priced liquid soaps. Detergents, which are commonly used for washing dishes and laundry, are not soaps; they are made from synthetic, often petroleum- based, chemicals. A small percentage of people react adversely to alka- line soap. A soap’s pH indicates the extent of its acidity or alkalinity. A pH of 7 is neutral, a higher number means the product is alkaline, and a lower number means it is acidic. High-alkaline soaps can cause the skin to become rough, red, and dry. People with dry skin may find that a superfatted soap (containing additional fats or oils such as moisturizing cream, lanolin, or cocoa butter) will leave the skin feeling more comfortable. However, a moisturizing lotion used after bathing is likely to be more effective. In 2001 Consumer Reports10 evaluated 30 soap and body wash products and concluded that the vitamin and botanical ingredients listed on their label were unlikely to have any effect. The editors advised finding a scent you like and shopping for price. Soaps remove visible dirt and debris from the skin but do not necessarily kill bacteria. Deodorant soaps include an antibacterial agent. Perspiration has no odor; body odor is caused by bacteria that thrive on perspira- tion. However, all soaps provide some protection from unwanted odors by washing off bacteria along with dirt, bacterial products, grease, and skin debris. Hand sanitizers, which can supplement or serve as an alternative to handwashing, are available in liquid, foam, or gel form. They contain an alcohol that quickly kills most bacteria and fungi and some viruses. The FDA regulates antimicrobial hand soaps and sanitizers as over-the-counter drugs. It states that adding triclosan to soaps and body washes has not been proven to provide any benefit over washing with regular soap and water.11 Hand sanitizers can reduce the transmission of many diseases but are not completely effective. The FDA12 has ordered several manufacturers to stop claiming that
their sanitizers protect against swine flu or MRSA (one of the so-called “flesh-eating bacteria” that is resistant to many antibiotics).
moiSturizerS
Moisturizing lotions, creams, and gels can help the skin feel smoother by increasing the amount of water retained in the outermost layer of the skin. The skin constantly renews itself through multiplication of cells beneath the surface. Dead cells are gradually pushed toward the surface, where they lose their moisture and eventually slough off. If the skin loses moisture too quickly, its outer layer dries out and may even crack. Glands within the skin produce oil that retards evaporation of the skin’s water. If the glands become less active (as usually hap- pens when people age) or too much oil is removed by washing, the skin will become too dry. Moisturizers contain ingredients that can penetrate the outer layer of the skin but not the living cells un- derneath. Emollient ingredients block moisture from leaving the skin by coating it with a thin layer of a slip- pery substance. The most common ones are petrolatum, lanolin, mineral oil, propylene glycol, and dimethicone. Humectant ingredients slow down the rate of water loss by attracting water from the skin and surrounding air. The most commonly used humectants are glycerine, propylene glycol, and phospholipids. Most moisturizers contain both types of ingredients, but products intended for dry skin have more oil, whereas products for oily skin contain only humectants. The best time to apply a moisturizer is after washing, while the skin is still damp, so that the moisturizer traps some of the water. In 2011 Consumer Reports13 tested 14 body lotions that cost from 14¢ to $1.15 per ounce. Its tests showed that some low-cost products worked better than expen- sive ones, but Cetaphil and Eucerin were most effective. In a previous report14 the editors concluded that people with oily skin or who live in a humid climate may only need regular cleaning and sunscreen use to keep their face looking its best, whereas people with dry skin may benefit from a moisturizer. They recommended the fol- lowing test for determining your skin type:
A few hours after washing with a nonmoisturizing soap hold pieces of eyeglass lens-cleaning paper for 10 seconds against your forehead, nose, chin, and a cheek. If the paper from all areas is oily, your skin is oily. If the paper from all areas is dry, your skin is dry. For normal skin, the paper held to the cheek will be less oily than the paper held to the forehead, nose, and chin.
Part Five Other Products and Services382
QueStionable ClaimS
A certain amount of wrinkling is inevitable as people get older. Both cigarette smoking15 and excess sun exposure can cause facial wrinkling to become apparent in middle age. When both occur, the effects are multiplied.16
Many cosmetic manufacturers suggest that their moisturizers and other products can help people look more youthful. Moisturizers may help the skin look and feel better for a few hours. By preventing water loss from the skin, they can fill in fine lines to make the skin look smoother. Alpha hydroxy acids (AHA) can facilitate removal of dead skin cells, making the skin smoother and enabling the moisturizer to work more effectively.17
Although some evidence suggests that AHA may facili- tate skin repair, the FDA has received reports of adverse reactions such as severe redness, swelling (especially in the area of the eyes), burning, blistering, bleeding, rash, itching, and skin discoloration. Because they have been available only since 1992, their long-term effects are unknown. An industry-sponsored study found that people who use AHA products have greater sensitivity
to sun, which may mean that they increase the risk of photoaging and skin cancer.18
Paula Begoun,2 author of Don’t Go to the Cosmet- ics Counter Without Me, advises her readers to be wary of phrases like “appears to,” “leaves the skin looking smoother,” “changes the appearance of,” “lessens the signs of,” “reduces the chances of,” “reduces the tem- porary signs of aging,” and “reverses the visible damage of aging.” She states that because they refer to the skin’s appearance, rather than its structure, they are cosmetic claims and do not have to be truthful. Her book discusses the ingredients in more than 10,000 cosmetic products and states what she and people who responded to her surveys have concluded about the products. Table 18-1 comments on several questionable cosmetic ingredients. Nicholas Perricone, M.D., who wrote The Perricone Prescription and several other books, has developed elaborate antiaging programs that include dietary strate- gies, exercise, skin products, dietary supplements, and 8 to 10 glasses of spring water per day. The total cost of the products is about $5000 per year. Perricone claims that “inflammation” is the underlying cause of aging and
Substance
Aloe vera
Amniotic fluid
Bovine albumin
Cerebrosides and ceramides
Collagen and elastin
Liposomes
Nayad
Vitamin E
Other vitamins
QueStionable CoSmetiC ingredientS
Table 18–1
Sources: Modified from data in Consumer Reports19 and FDA Consumer.20
Description
Plant with anti-irritant properties
Fluid that surrounds the developing fetus (from cow or ox) to protect it from injury
Protein from cow milk or cow blood
Phospholipids similar to compounds formed in the skin that help the skin retain its moisture
Proteins under the top layer of skin; tend to deteriorate with age or sun damage
Microscopic capsules made from phospho- lipids and other fatty substances, some of which occur naturally in the skin
Trade name of a yeast extract
Fat-soluble vitamin that can preserve the fatty components in cosmetic creams and lotions
Vitamins included in various cosmetic formulations
Comment
Most skin lotions listing aloe vera as an ingredient do not contain enough (5% to 10%) to work as an anti- irritant; those that do are expensive
Does not promote tissue growth or remove wrinkles
Federal court ordered manufacturer to stop claiming it can give a “face lift without surgery”
The claim that they “help fortify and replenish the skin’s moisture barrier” is merely a fancy description of what all emollient ingredients in moisturizers do
Skin proteins cannot be “replenished” by a cosmetic product
Does not “work beneath the skin’s surface” or carry useful ingredients to underlying skin layers because moisturizers do not penetrate living cells
Use claimed to result in “smoothing of lines and wrinkles.” FDA has no data to substantiate or refute this claim
Prevents products from discoloration and rancidity, but has no proven value for skin preservation or “rejuve- nation”
Vitamins applied to the skin do not nourish the skin
Chapter Eighteen Skin Care and Image Enhancement 383
that his program will counter that. Hall and Barrett21 have concluded:
Although some of his advice is standard, most of his recom- mendations are based on speculation and fanciful interpreta- tion of selected medical literature. He makes lots of money by convincing patients and consumers, but he hasn’t succeeded in convincing critical thinkers, doctors, scientists, or anyone who wants to see hard evidence. Perricone’s “prescription” isn’t science; it’s creative salesmanship.
Despite Perricone’s dubious claims, his books have made best seller lists and the Public Broadcasting System (PBS) has featured him during fundraising campaigns. The American Academy of Dermatology22 has warned that many “antiaging” products referred to as cosmeceuticals contain ingredients that have been stud- ied individually but not in combination. Many products are sold with false claims that rub- bing them on the skin will eliminate “cellulite.” This subject is discussed in Chapter 12. ShopSmart magazine1 recommends avoiding eye- lash growers, under-eye circle erasers, hair smoothers (may contain formaldehyde), lip plumpers, and scar eliminators.
Enforcement Actions It is illegal to claim that a cosmetic product can prevent or eliminate wrinkles, repair sun-damaged skin, or retard or reverse the aging process of the skin. Specific statements to that effect would be drug claims because they would indicate that the product is intended to affect a bodily function or the body’s structure. However, if true, it is
legal to make a cosmetic claim that a moisturizing prod- uct can temporarily reduce the appearance of wrinkles. The FDA, which has jurisdiction over labeling claims, has warned about 25 manufacturers to stop mak- ing antiaging (drug) claims for their skin care products. Most have complied, but other many other companies still make them. The FDA’s most significant recent ac- tion related to skin claims was a letter ordering Basic Research LLC of Salt Lake City, Utah, to stop claiming that StriVectin would reduce stretch marks, fine lines, wrinkles, and crow’s feet.23
The Federal Trade Commission, which has jurisdic- tion over advertising claims, could attack the deceptions that are common in cosmetic advertising, but it has not done so.
WrinkleS and age SpotS
In 1996 the FDA approved the marketing of Renova, an over-the-counter (OTC) tretinoin product capable of slightly reducing fine wrinkles and age spots. The prod- uct is similar to the prescription acne remedy Retin-A but has an oilier formulation. Renova is labeled as “an adjunctive agent for use in the mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone.” The label must also state: “Renova does not eliminate wrinkles, repair sun dam- aged skin, reverse photoaging, or restore more youthful or younger skin.” The FDA’s action was based on evidence from two clinical trials in which patients treated with Renova for 24 weeks were compared with patients who used an emollient cream. Although about 65% of the Renova group showed some improvement of wrinkling and mot- tling, Consumer Reports on Health24 noted: (a) 40% to 50% of the people who used the emollient cream reported similar improvement; (b) nearly all users experienced redness, dryness, itching, and peeling of the skin; and (c) the benefit will disappear if use of the drug is stopped. OTC tretinoin, marketed as Renova, costs about $190 for a tube that should last 4 to 6 months. No study has determined how safe it is to use Renova for longer than 48 weeks. In 2010, Consumer Reports25 tested nine anti-wrinkle serums that were claimed to reduce the appearance of wrinkles. After 6 weeks of use, the effectiveness of the best products was limited and varied from subject to sub- ject. Every serum produced a visual change in wrinkle length or depth for at least one person and did nothing for some of the others.
√ Consumer Tip
Healthy Perspectives on Makeup • The information you get at the cosmetics counter is
rarely accurate when it comes to skin care. • There are no antiaging products available besides
sunscreens. • No one needs more than a daytime moisturizer that
contains a sunscreen and a nightime moisturizer without a sunscreen.
• Spending more money doesn’t mean you will look more beautiful. Knowing how to apply makeup is the key to looking good.
• All the makeup and skin care products in the world can’t cover up an unhealthy lifestyle.
• Find ways to feel good about yourself that don’t come from your appearance.
Paula Begoun2
Part Five Other Products and Services384
Several laser devices are FDA-approved to treat wrinkles or resurface the skin. The FDA cautions that skin abrasion, whether achieved by lasers, chemicals, or abrasive materials, means removing one or more layers of skin, which can be painful and could cause redness, swelling, or scarring, depending on how each person heals.26
Fade CreamS
Skin bleaches (fade creams) are used to lighten skin discoloration (hyperpigmentation) caused by freckles, flat moles, and age spots. However, they make the skin especially sensitive to the sun. An FDA expert panel reported that the only safe and effective ingredient for OTC use is hydroquinone in concentrations from 1.56% to 2%. Nonprescription products containing 2% hydro- quinone include Esoterica, Porcelana, and Artra. More concentrated products are available by prescription. Hydroquinone does not actually bleach the skin but inhibits the cells that produce melanin. Since these cells are deep within the skin, lightening products work slowly, if at all. Results may not be apparent for 3 months. Users (including those who do not sunbathe) should apply a sunscreen because fade creams increase sensitivity to the sun. Consumer Reports27 has offered these additional comments:
• When fade creams work, they work only against freckles and age spots.
• They will not cause blemishes to completely disappear. • Apply them only to the pigmented areas and not the sur-
rounding skin. • If no results are obtained after 3 months, consider profes-
sional treatment. • Protect hands and face from excessive exposure to the sun
to prevent pigment production. • Foundation creams can cover skin blemishes and serve as
an alternative to fade creams.
antiperSpirantS and deodorantS
Sweating is a natural body function that helps regulate body temperature and helps protect the skin against dry- ness. Normal skin secretions do not have an objection- able odor. However, when skin bacteria interact with sweat, the result may be unpleasant. There are two types of sweat glands: eccrine and apo- crine. Eccrine glands, the main source of perspiration, are located near all skin surfaces except the margins of the lips and certain parts of the sex organs. They secrete watery or water-soluble substances. The apocrine glands are located in the armpits, around the nipples, on the
abdomen, and in the genital area. They do not function in body temperature regulation but respond to hormonal stimulation. After puberty they produce a milky secre- tion that emits a strong odor when metabolized by local bacteria. Heat and emotional stress can trigger activity of both types of glands. Antiperspirants reduce secretions from the eccrine glands by astringent action, which contracts the skin to prevent the flow of perspiration. Deodorants either reduce the number of odor-causing bacteria in the un- derarm area or cover up the odor. Combination products are also available. Antiperspirants are regulated as OTC drugs because they affect a bodily function. Deodorants are regulated as cosmetics. More powerful antiperspirant drugs are available by prescription. However, no product can stop sweating completely. The University of California at Berkeley Wellness Letter28 stated: (a) bathing is by far the best way to control body odor; (b) antiperspirants and deodorants have been oversold; (c) many people use more of them than they need; (d) people who use these products daily should try using them two or three times a week to see whether this works just as well; (e) sticks, roll-ons, and creams tend to provide more protection than aerosols; and (f) inhaling aerosol mist may pose a safety hazard. Some ingredients in antiperspirants and deodorants can cause allergic reactions. People who are unable to tolerate these products may be helped by washing more frequently or by using an antibacterial soap. Hyperhidrosis is an abnormal condition in which people sweat excessively even when the temperature is cool or when they are at rest. Several types of medical treatment are available, but some cases are difficult to control.
aCne Care
Acne is a skin condition characterized by whiteheads, blackheads, pimples, and sometimes cysts, all of which result from the clogging of sebaceous glands. About 80% of teenagers are afflicted, and it remains a problem for many people into their 20s and sometimes beyond. At puberty the sebaceous glands increase in size and activity and secrete more sebum (a mixture of fats and waxes), which normally exits from the pores and lubricates the skin and hair. Figure 18-1 shows the anatomic relationship be- tween a hair follicle and its nearby sebaceous glands, which secrete sebum into the follicle. In acne, ducts from these glands become plugged with comedos com- posed of sebum and dead cells. If bacteria invade, the
Chapter Eighteen Skin Care and Image Enhancement 385
surrounding skin can become inflamed, and pimples or pustules may form. Most people with acne have a mild (noninflammatory) form and get occasional whiteheads or blackheads. Severe (inflammatory) acne involves a constant outbreak covering the face and sometimes also the neck, back, chest, and groin. Pimples and pus-filled cysts occur and can result in pitting and scarring of the skin. Heredity is often an important factor in acne. In adult women, cosmetics (especially greasy, heavy creams) may be the cause. In some, acne can be triggered by hor- mone fluctuations. Jobs that involve exposure to grease or oil may also be a factor. There is little evidence that acne is related to diet. However, if self-experimentation suggests that a specific food aggravates acne, avoiding the food may be reasonable. Acne cannot be prevented or cured, but it can be controlled and minimized. Only about 10% of cases need medical supervision. Most cases respond to self- treatment with nonprescription products, although physician-directed treatment might produce quicker and better results. The first step is to keep the skin as free of oil as possible by washing twice a day, shampooing as needed, keeping oily hair off the face, and avoiding cosmetic products that contain oil or grease. If this is insufficient, the next step should be treat- ment with a topical product containing benzoyl peroxide. Benzoyl peroxide produces irritation that speeds up the turnover of cells lining the follicle. This increases the sloughing of these cells and promotes resolution of the comedos. Benzoyl peroxide often stings and burns the skin and sometimes causes redness and scaling. Self- treatment can be done with an OTC product, but a medi- cal consultation would be more prudent. A doctor can determine which type of product would be best, provide
instructions about comedo removal, and advise whether anything else is needed. The 2.5%, 5%, and 10% benzoyl peroxide solutions are equally effective, but the lowest concentration is the least irritating.29
Benzoyl peroxide is the key ingredient in Proactiv, which is widely advertised through TV infomercials that feature Justin Bieber, Jessica Simpson, and other celebrities (see Personal Glimpse box). If treatment with benzoyl peroxide is not effective, a doctor may prescribe a topical retinoid such as treti- noin (Retin-A), which is stronger but more irritating to the skin. An antibiotic may also be prescribed. Because tretinoin increases susceptibility to sunburn, prolonged exposure to the sun should be avoided, and an effective sunscreen should be used. Accutane (isotretinoin), a prescription drug taken orally, can be prescribed for severe acne that does not respond to other forms of therapy. Treatment takes
Skin surface
Hair follicle
Hair root
Hair shaft
Figure 18-1. Cross-section of skin. When the openings of sebaceous glands are blocked by sebum, cells and sebum accumulate to form plugs (comedos).
photograph from fDa ConSumer
Sebaceous gland
Personal Glimpse
Proactiv Hype
Gone are the days when getting rid of acne meant a trip to the drugstore for Stridex or Clearasil. Now the product the kids clamor for is Proactiv. . . . So what’s in this blockbuster drug? After all, the basic “Proactiv System” will cost you $19.95 (though it’s “a $72 value”). The short answer is not much. Make a few clicks around Proactiv’s Web site and you’ll find out the active compound is benzoyl peroxide. That’s the same stuff in Stridex, Clearasil and just about every nonprescription acne medica- tion available in drugstore aisles across America. A tube of the same compound costs $5.25 at my local pharmacy. . . . Perhaps the three-step “Proactiv System” helps make it easier for teens. But the real key to Proactiv’s success is celebrity. Endorsements have helped make it the acne product to buy. . . . My biggest problem is something else, though: How hard they work to equate confidence with beauty and nothing else. Every celebrity testifies that having pimples was the source of all their insecurities. . . . They all claim that Proactiv gave them the confidence they needed to be their best. As a physician who sees plenty of teens with real confidence problems and the consequences they engender—eating disorders, depression, anxiety, drug use—I’d like to see a com- pany with this much influence pull a few gears back on that message. Rahul Parikh, M.D.30
Part Five Other Products and Services386
several months and is expensive. Women who are preg- nant or might become pregnant should not use Accutane because it can cause severe birth defects. Accutane can also cause severe depression and psychosis. In 2005, the FDA initiated a risk management program (iPLEDGE) intended to prevent women who are pregnant or might become pregnant from taking Accutane. To obtain the drug, patients must complete an informed consent form and undergo counseling about the risks and requirements for safe use. Women who are capable of getting pregnant must also have a negative pregnancy test and agree to use two separate forms of effective birth control at the same time one month before taking Accutane, while taking it, and for one month after taking it.31
Ultraviolet light from sunlight or a sunlamp can be effective for some people with acne but will aggravate the condition of others. However, it is no longer recom- mended, because it increases the risk of skin cancer. Dermatologists and plastic surgeons can improve the appearance of people with severe acne scars. The procedures they use include dermabrasion (facial plan- ing), chemical peels, cryosurgery, and injections of filling material.
head hair and SCalp Care
The hair shaft, which is the visible part of the hair, is a complex, nonliving structure made of protein. The shaft is produced by the bulb-shaped hair root, at the bottom end of the shaft, deep in the scalp (see Figure 18-1). The shaft and root are encased together in a cellular structure called the follicle, which supplies nourishment and support. The healthy scalp of a young adult normally has about 100,000 hairs and loses 50 to 100 each day. In most people, the loss is not significant because the re- placement rate is about the same as the rate of loss. As people age, however, the rate of loss increases, and a permanent thinning may be inevitable. Hair can be split or otherwise damaged by rough handling or excessive use of bleach, hair dye, or certain other hair-care products.
Shampoos and Conditioners Some oiliness and flaking of the scalp are normal. Se- baceous glands located just beneath the skin secrete an oil that lubricates the hair follicle and the scalp, keeping the hair glossy and the scalp comfortable. Washing the hair once or twice weekly is usually sufficient to control oiliness and dandruff, but people with an oily scalp may have to wash daily. Soaps remove the oil and leave a residue of mineral salts on the hair shafts that can make
the hair look dull. So it is better to use a shampoo that enables some of the natural oil to remain or that contains lanolin as a replacement. That way the hair remains shiny and manageable. The main function of shampoo is to clean the hair by removing dirt, dead skin scales, and excess sebum. Shampoos generally contain (a) water, (b) a synthetic detergent, (c) a sudsing agent that makes rinsing easier, (d) antistatic and detangling agents, (e) a moisturizing agent, (f) a thickener to give the shampoo a pleasing consistency, and (g) a fragrance. Many shampoos contain a conditioner such as collagen, protein, amino acids, or panthenol. Conditioners are intended to counteract the depletion of natural hair oils, but most are washed away. People who want maximum benefit from a conditioner should apply a separate product after shampooing. Dry shampoos are useful for people who are ill or incapaci- tated and unable to wash their hair. These are left on the hair for a specified time and then are brushed or combed out. Begoun33 states that shampoos are 50% to 90% wa- ter, and exotic ingredients such as awapuhi and burdock root have no effect on the hair. She also notes that people can tell immediately after use if their hair feels clean, soft, defrizzed, and easy to style, and whether or not it stays put. Most people who wash their hair frequently do not need a medicated shampoo.
Personal Glimpse
FTC Zaps “Acne Cure” Software32 In 2011, marketers of two mobile phone applications signed consent agreements under which they must re- frain from making baseless claims that their products could successfully treat acne by generating colored lights. In both cases, users were advised to hold the display screen next to the problematic skin area for a few minutes daily while the application was activated. Software developer Koby Brown and dermatolo- gist Gregory W. Pearson, M.D., doing business as Dermapps sold about 11,600 copies of “AcneApp” through the iTunes store for $1.99. Their settlement included payment of $14,294 to the FTC. Software developer Andrew N. Finkel sold about 3300 copies of “Acne Pwner” through Google’s Android Market- place for $.99. His settlement included payment of $1700. These were the first cases brought by the FTC against health claims in the mobile application marketplace.
Chapter Eighteen Skin Care and Image Enhancement 387
Consumer Reports34 adds that the “workhorse” in- gredients in shampoos are (a) detergents (or surfactants), such as ammonium lauryl sulfate, which clean the hair; (b) cationic polymers that can attach to the hair shaft to add smoothness and volume; and (c) silicones, such as dimethicone, that can coat the hair, making it feel soft, pliable, and easy to comb. The magazine has also noted that other ingredients such as herbs, vitamins, proteins, AHA, and moisturizers do nothing to improve the condi- tion of the hair. Its tests have found that expensive brands performed no better than inexpensive brands. Hair-care products sold at barber shops and hair sa- lons tend to be more expensive than those sold through retail outlets such as drugstores and supermarkets, but there is no reason to believe they are better.
Dandruff The surface layer (epithelium) of the scalp renews itself once a month. Dead scalp cells are constantly being pushed from the skin’s deepest layer to its surface, where they gradually die. Usually this process is not apparent. Dandruff occurs when the dead cells are shed in clumps or flakes. It is a problem with the scalp, not the hair. Nearly everyone has dandruff to some extent. Dandruff is usually treatable with an OTC product and causes no general health problem or permanent damage. But care should be taken not to confuse simple dandruff with other conditions that cause flaking of the scalp, such as seborrheic dermatitis or psoriasis. Five ingredients are approved for use in shampoos, rinses, or products consumers apply to the scalp: salicylic acid, pyrithione zinc, sulfur, selenium sulfide, and coal tar. However, in many cases, washing the hair more often will provide adequate dandruff control.35 Seborrheic dermatitis is characterized by redness, inflammation, itching, and flaking of the skin. It most commonly affects the scalp and face but can also occur on the ears, chest, and other parts of the body. Hormones, heredity, diet, emotions, medications, cosmetics, and climate can be factors in seborrhea, but often the cause is an infection with a yeast (fungus) called Pityrosporum ovale. Mild cases are treatable with OTC products, but severe cases should be treated by a physician. Some cases respond well to treatment with a shampoo containing ketoconazole, which kills the fungus. Psoriasis is an inflammatory skin disease in which cells reproduce about 10 times faster than normal, but the rate of shedding is unchanged.36 Live cells then ac- cumulate and form thick patches covered with flaking skin. The scales can occur in many areas of the body, most commonly the knees, elbows, back, and buttocks.
Although coal tar and salicylic acid preparations are approved for OTC use against psoriasis, more effective drugs are available by prescription. Because coal tar can make skin overly sensitive to sunlight, people using a coal-tar product should be cautious about exposing their skin to sunlight.
Hair Removal and Reduction Excess hair (hirsutism) results from an overabundance of androgens (male hormones) produced in the adrenal glands and ovaries. Many women of reproductive age have at least a few long, coarse facial hairs. Except for electrolysis, all methods of hair removal are temporary. The reappearance time depends on the location of the hair and how much of the hair is removed. Shaving is the fastest method but results in the quickest regrowth. Tweezing is also quick and, because it removes a portion of the hair below the skin, tends to have a longer-lasting effect than shaving. Small amounts of hair can be removed with a pumice stone or other abrasive. However, this can irritate the skin. Waxing, which is similar in effect to tweezing, is done by applying melted wax to a hairy area. When the wax cools, it can be stripped off in the direction of hair growth, carrying hairs with it. Waxing can irritate the skin and can cause infection of the hair follicles. Depilatory creams and lotions contain a chemical agent (most commonly thioglycolate) that breaks down the protein in the hair, turning it into a soft mass that is easily wiped off the skin. The root of the hair is left intact. The products are applied to the skin and removed after 5 to 15 minutes. Since the chemicals can irritate or burn the skin, depilatories should not be used without testing them. The test is carried out by applying the product to a small area of skin and inspecting the area 24 hours later. Laser devices generate intense heat that injures the follicle to stop or delay growth. Stable reduction in hair growth is possible but may require multiple treatments. Dark hair responds best. Treating a small area may take only a few minutes, but large areas can take several hours. Sun exposure should be minimized for at least a week afterward because the treated skin will be very sensitive to ultraviolet radiation. The risks include loss of skin pigment, blisters, and scarring. Two devices are FDA-approved for home use on areas of the body other than the face. People contemplating the use of a home laser device should discuss the pros and cons with a dermatologist.37 Electrolysis is performed by inserting a fine needle into the hair follicle and delivering an electric current to destroy the hair root. Its safety and effectiveness depend
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on the expertise of the operator. The competence of non- medical electrolysis operators varies widely. Thirty-two states license electrologists. Two professional organiza- tions offer certification based on a written examination. Electrolysis devices are also available for self-treatment. Electrolysis can be tedious, time-consuming, ex- pensive, and uncomfortable, depending on the areas involved and the amount of hair to be removed. In addi- tion, excessive exposure to electric current can damage the skin and cause scarring or infection. A fresh needle should be used for each patient to prevent the spread of hepatitis or HIV. People considering electrolysis should consult a dermatologist to determine whether it is advis- able and to obtain the name of a suitable practitioner. Growths that contain hair, such as moles, should be diagnosed and evaluated by a physician. Severe cases of hirsutism should be medically inves- tigated because there may be an underlying disease, such as an adrenal or ovarian tumor, for which treatment is needed. If not, the physician may advise taking medica- tion to inhibit androgen production or to block its effect on hair follicles. Such drugs can have undesirable side effects, and none is uniformly effective. The limitations of the therapy and the extent of the side effects should be discussed before making a decision about treatment.
Hair Relaxers, Perms, and Dyes Many hair products used to straighten (“relax”), curl, or dye hair contain chemicals that can burn the skin. The FDA Office of Cosmetics and Colors states that this product category is among its top consumer complaint areas.38 The main problems are scalp irritation and hair breakage. There have also been reports of small children ingesting straightening chemicals and suffering burns to the face, tongue, and esophagus. Although some products are promoted for self-use, professional application is likely to be safer. Whether hair chemicals are applied at home or in a hair salon, care should be taken to keep them away from the eyes. Begoun33 cautions that descriptors that imply spe- cial safety (e.g., “hypoallergenic” and “dermatologist tested”) are not regulated or legally defined and should be regarded as meaningless.
hair loSS
Temporary hair loss may be associated with hormonal imbalance and can occur after surgery, childbirth, ra- diation, cancer chemotherapy, or certain diseases that produce a high fever. Other causes of temporary hair loss include reactions to hair products and procedures (per- manent waving, drying, and weaving); iron deficiency,
toxic intake of vitamin A or mercury; and medications such as heparin and warfarin (anticoagulants), am- phetamines, l-dopa, and propranolol (Inderal). In such instances, regrowth usually occurs within a few months. There is no specific therapy for temporary hair loss. To minimize it, one should brush hair only moderately with a soft brush, shampoo regularly and gently with a mild shampoo, dry hair by letting the towel soak up moisture rather than by vigorous rubbing, and avoid hair styles that require pulling the hair excessively. Alopecia areata, a condition in which hair falls out in patches, occurs with equal frequency in men and women. The cause is unknown, but it may be related to heredity or to the body’s immune system. About 90% of people with this condition regrow their hair spontaneously. The so-called normal or common baldness is male- pattern baldness (androgenic alopecia), which is respon- sible for 95% of all hair loss in men and also occurs in women. Although a specific cause cannot be identified, it is probably related to hereditary factors (especially among Caucasians), an excess of male hormones (andro- gens) such as testosterone, and possibly attacks on scalp hair follicles by the body’s immune system. Nutritional deficiencies are not a factor. Among African American women, the use of traction hair styles such as braids and weaves may contribute to localized baldness.39 Minoxidil, marketed as Rogaine, has some ability to retard male-pattern baldness. Minoxidil was originally approved by the FDA for the treatment of high blood pressure. However, in certain concentrations it was found to spur the growth of body hair. In 1988 the FDA approved minoxidil as a prescription drug for the treat- ment of hair loss. Studies indicated that applying minoxi- dil to the scalp would restore hair growth in some men with thinning hair. In 1996 the FDA switched minoxidil to nonprescription status, enabling it to be marketed as Rogaine Topical Solution. No other OTC products are legally marketable as hair-growth stimulants. The FDA states that about 25% of men and 20% of women who use Rogaine appropriately will attain meaningful (at least moderate) hair growth.40 The best responders are usually under 40 years old, have a history of hair loss for less than 10 years, and have a bald area less than 4 inches in diameter near the top of the skull. In 1997 the FDA approved Propecia for hair loss in men, making it the first such treatment in pill form. The active ingredient in Propecia is finasteride, which was approved initially in 1992 as Proscar, a treatment for prostate enlargement. It was observed that some pa- tients being treated for prostate enlargement had some regrowth of hair in areas of male-pattern hair loss. Sub- sequent studies found that 1 mg of finasteride produced
Chapter Eighteen Skin Care and Image Enhancement 389
hair growth in men with male-pattern hair loss. (Proscar contains 5 mg of finasteride; Propecia contains 1 mg. Both are prescription drugs.) The Medical Letter41 states (a) both Rogaine and Propecia can produce a modest increase in hair on the scalps of young men with mild-to-moderate hair loss, (b) each must be taken daily and continued indefinitely to maintain the effect, (c) the long-term safety of both drugs has not been determined, and (d) the slight advan- tage of 5% minoxidil (Rogaine Extra Strength) over 2% minoxidil does not justify the higher cost and possible risk of the higher concentration. . Hair Replacement Surgery Hair replacement is a form of cosmetic surgery in which patches of skin containing healthy hair follicles are transplanted into areas that are bald or becoming bald. The procedures include punch grafting, strip grafting, scalp reduction, scalp expansion, and various types of flap grafting.42 In punch grafting, a punch is used to remove small areas of bald scalp and replace them with plugs of healthy scalp. Minigrafting and micrografting involve transferring only a few hairs at a time. In some cases they are used to make the hairline created by punch grafting look more natural. In strip grafting, strips of bald skin are cut from the top of the head and replaced by strips of healthy scalp. In scalp reduction a portion of bald scalp is removed and the wound is closed by pull- ing surrounding areas of the scalp toward the bare spot. The remaining bald spot can be filled with transplanted hair plugs. In scalp expansion, a balloon-like device is inserted under part of the scalp and gradually filled with dilute salt water, causing the skin to stretch and grow so that a subsequent scalp reduction can cover a larger area. Flap grafting is done by removing bald areas and replacing them with surrounding areas of hairy skin that have been lifted and swiveled into position. The swiv- eled portion is left attached to its original location until a new blood supply is established. These procedures cost thousands of dollars and are often unsuccessful. Sometimes the areas from which the grafts are taken fail to regrow hair properly. Even suc- cessful transplants do not last indefinitely, because the transplanted hair lasts only as long as it would have at its original location. A hairpiece, wig, hair weaving, or simply accepting one’s baldness may be a better choice.
Hair-Growth Frauds Hundreds of bogus baldness products have been market- ed by mail and through health-food stores, beauty salons, barber shops, department stores, radio and television ads, and the Internet. Most include vitamin combinations
said to provide the nutrients needed to nourish the hair. Although severe malnutrition can result in hair loss, there is no evidence that dietary supplements will increase hair growth for anyone who is eating normally. Since the hair shaft is dead tissue, no product can make it healthier or faster-growing by “feeding” it. Some entrepreneurs have claimed that scalp mas- sage and heat treatments can stimulate hair growth by increasing circulation of the scalp. This claim is readily refuted by the fact that bald scalps do not lack adequate circulation; they bleed readily when cut and can sustain transplanted hair. The following cases illustrate government action against bogus hair products. In 1983, to settle charges by the FTC, Braswell, Inc., and its president, A. Glenn Braswell, agreed to pay $610,000 in civil penalties and to stop claiming that any product or service could cure or prevent hereditary baldness. Braswell was also convicted of mail fraud and perjury and served a brief prison sentence. The mail- fraud charges involved the faking of “before-and-after” photographs for ads for bust-developer, hair-growth, and cosmetic products.43
In 1997, Pantron I Corporation and Hal Z. Letterman settled FTC charges that claims made for their Helsinki Formula were false and misleading. The FTC noted that defendants were pioneers of the program-length infomercials and had grossed over $100 million between 1985 and 1990. The settlement prohibited them from making claims not approved by the FDA that any bald- ness product is effective against hair loss or promotes regrowth of lost hair. The company filed for bankruptcy in 1994, but the bankruptcy court eventually approved payment to the FTC of $27 million from the bankruptcy proceeds.44
In 2001, ValueVision (a Home Shopping Network subsidiary) settled FTC charges that it falsely advertised that NutriFirm Vitamin H Serum, a topical solution that contained biotin, would prevent or reduce hair loss, especially for women who had recently given birth.45
tattooS and permanent makeup
The inks used in tattoos and permanent makeup (also known as micropigmentation) and the pigments in these inks are subject to FDA regulation as cosmetics and color additives. However, the FDA has not attempted to regulate the use of tattoo inks and the pigments used in them and does not control the actual practice of tattooing. The complications of tattooing include infection, allergic reactions, granulomas (unwanted nodules), and large scars (keloids). However, the most common
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problem that develops is the desire to remove them. Tat- toos can fade, and their pigment may migrate, causing them to look blurred. Permanent makeup that looked attractive when installed may later clash with changing skin tones or body contours, or go out of fashion. In- dividuals who are considering these procedures should think carefully about their decision because removing a tattoo or permanent makeup can be very difficult.46
bodY pierCing
Body piercing involves the creation of an opening in the body for the purpose of inserting jewelry or other deco- ration. It includes piercing of an ear, lip, tongue, nose, eyebrows, navel, and genitalia. Such procedures have been associated with many medical problems includ- ing chronic local infection and persistent pain, contact dermatitis, local swelling, hematoma formation, and cyst formation within the skin. The American Academy of Dermatology47 discourages its use and warns that hepatitis, HIV, and other infections can be transmitted if proper sterile technique is not used.
treatment oF Common Foot problemS
This section discusses the management of athlete’s foot, corns, calluses, and warts. Athlete’s foot (tinea pedis) is the most prevalent superficial infection in humans. It is classified symptom- atically as acute (weeping and inflammatory lesions) or subacute/chronic (dry, scaly skin). In both cases, itch- ing, burning, and stinging are the primary complaints. The fungus, which also causes “jock itch,” is probably acquired most often by people walking barefoot on infected floors. Treatment preparations are available in creams, ointments, liquids, powders, and sprays. The FDA expert advisory panel judged the follow- ing ingredients in OTC antifungal medications as safe and effective: clioquinol, tolnaftate, and undecylenic acid and its salts, haloprogin, miconazole nitrate, and nystatin. Tolnaftate can be used to prevent as well as to treat athlete’s foot. Effective therapy for athlete’s foot involves proper hygiene that includes (a) cleaning and thoroughly dry- ing the feet daily, (b) reducing heat and perspiration by wearing light shoes and cotton socks for ventilation, (c) changing clothing and towels frequently, (d) using a drying powder between toes, and (e) wearing protective footwear in public and home shower and bathing areas. A medical doctor or podiatrist should be consulted if the eruptions are oozing, the space between the toes has a foul odor, the foot looks inflamed or swollen, or the patient has diabetes or eczema.
Calluses and corns are protective responses to friction or pressure, usually caused by ill-fitting shoes, improperly fitting hosiery, or orthopedic problems. Cal- luses are skin thickenings with no central core, usually found on the palms of the hands and soles of the feet. Corns are skin thickenings with central cores that press on nerve ends, causing pain. The types include (a) hard corns, most commonly found on joint surfaces; (b) soft corns, resulting in a whitish thickening of the skin be- tween the fourth and fifth toes; (c) intermediate corns, which are hard-rimmed, soft in the center, and painful; and (d) neurovascular corns, which contain a large amount of blood and occasionally rupture. Most OTC products for treating corns and calluses contain salicylic acid, which softens and destroys the outer layer of the skin. The product is applied once or twice daily for up to 2 weeks. If no improvement occurs within 2 weeks, a medical doctor or podiatrist should be consulted. Warts are caused by a viral infection of the epider- mis (outer layer of the skin). They are contagious, and scratching can spread them. They can occur on any part of the body but most often appear on the hands, fingers, and soles of the feet. They typically are rough, scaly areas of the skin that have a cauliflower-like appearance. Those occurring on the feet (plantar warts) can resemble calluses but tend to be painful because of the pressure and irritation of weight-bearing. (Calluses are usually not tender.) Many warts disappear eventually without treatment, particularly those in children. For this reason, unless they cause pain or embarrassment, watchful wait- ing may be advisable. Wart treatments include freezing with liquid nitro- gen or dry ice, burning with an electric cautery, surgical excision, and destruction with chemicals. Small warts of the hands or feet are also self-treatable with an OTC salicylic acid product, which is applied once or twice daily as needed for up to 12 weeks. There is also a home- use product that includes salicylic acid and a freezing spray. Facial or genital warts should be treated only by a physician. When using a salicylic acid product, it is important to follow the directions carefully so the surrounding skin does not get burned. The product should not be used on skin that looks irritated, infected, or reddened; nor should it be used by anyone with diabetes or poor circulation.
poiSon ivY
Poison ivy and similar plants (poison oak, poison sumac) contain a resin that can cause allergic dermatitis in about 70% of the population. It can develop as a result of di- rect contact with plants or indirectly from contaminated
Chapter Eighteen Skin Care and Image Enhancement 391
clothing, pets, airborne particles, or other sources. A thorough washing with soap and water within 10 to 20 minutes after exposure may remove the resin from the skin before it causes trouble. Clothing can be decon- taminated by machine washing with laundry detergent. Itching may be relieved by applying cold compresses, a paste made of baking soda and water, calamine lotion (without phenol), or a nonprescription hydrocortisone cream. In severe cases, a physician should be consulted.
inSeCt repellentS
Insect repellents are useful in protecting against mos- quitoes and ticks, some of which can transmit serious diseases. Consumer Reports48 found that several brands that contain DEET offer protection that can last 8 hours or more. For additional protection against mosquitoes, it advised against wearing scented products. For avoiding ticks, it recommended tucking pants into socks, wear- ing closed shoes and a hat, and inspecting yourself after venturing into wooded or grassy areas. Products that contain thiamine hydrochloride (vita- min B1) have been marketed with claims that they can keep mosquitoes and other bugs away. The FDA49warns that no such product has been proven safe and effective.
Sun proteCtion
The sun emits radiation at different wavelengths. The two that consumers should be concerned about are ultravio- let B (UVB) and ultraviolet A (UVA). UVB (“burning radiation”) is the most active radiation wavelength for producing both sunburn and skin cancer. Its greatest intensity occurs from late morning to early afternoon. UVA (“aging radiation”) penetrates the skin more deeply. It speeds up skin aging by causing changes in the skin’s collagen, the protein in its connective tissue. This ef- fect is most noticeable in people, such as farmers and fishermen, who work long hours outside. UVA rays may also cause changes in the eyes that lead to cataracts. The intensity of UVA is relatively constant throughout the day. Most people get about half of their lifetime sun exposure by the age of 18. DeSimone stated that an apt warning is “fry now, pay later.”50
When the skin is exposed to ultraviolet radiation the body responds by producing melanin, a dark pigment that provides some protection against sunburn. A “base tan” is equivalent to an SPF (sun protection factor) of 2 or 3. The darker a person’s skin, the more melanin and natural protection it has. However, even the darkest-skinned people can burn when sufficiently exposed to the sun, and melanin is not completely protective against skin cancer. Skin does not have to be burned for skin cancers
to develop. Damage also accumulates from everyday exposure. Skin cancers are most common among fair-skinned (lightly pigmented) people. There are three main types of skin cancer:
BaSal Cell CarCinomaS: These usually appear on the face, ears, or scalp as pale, waxlike, pearly nodules. They do not metastasize (spread through the body) but if untreated can harm surrounding tissues.
SquamouS Cell CarCinomaS: These appear as red, scaly, sharply outlined patches. If untreated, they can metastasize.
melanomaS: These typically start as a molelike growth that increases in size and darkness. They metastasize early and are highly malignant.
More than 95% of basal and squamous carcinomas are easy to cure when detected early. About 3.5 million cases are diagnosed annually. The American Cancer Society51 estimated that in 2011 about 70,000 new cases of melanoma of the skin would be diagnosed and about 8800 people would die from the disease in the United States. Sunscreen products (also called sunblock products) help absorb, block, or scatter UVB radiation. They are used primarily to prevent sunburn but can also help people tan without burning. The products are available as lotions, creams, gels, oils, alcohol solutions, and wax substances for lips. Some come in spray-on dispensers. Their potency is expressed by the letters “SPF” and a number that follows. The higher the number, the greater the protection. SPF 15 products permit sun exposure for a few hours with no tan or burn. Sunscreen should be applied 15 to 30 minutes before sun exposure begins. The FDA recom- mends liberal application using about an ounce for an average-size person. Since some sunscreens can irritate the skin, it may be prudent to test for this by applying a small amount to the inside of the upper arm one day be- fore exposure to the sun is planned. Consumer Reports52
recommends using a broad-spectrum sunscreen that is at least SPF 30 and applying it every 2 hours and after swimming or sweating. “Broad spectrum” refers to the ability to block UVA as well as UVB. The National Weather Service issues daily forecasts of the intensity of ultraviolet light expected the next day in about 60 cities. This UV Index is expressed as minimal (0–2), low (3–4), moderate (5–6), high (7–8), and very high (10–15). The higher the number, the more important it is to take protective measures such as wear- ing tightly woven clothing and a broad-brimmed hat, using sunglasses, or avoiding the sun altogether. The daily values are available on the weather page of many newspapers, as a free app for many smart phones, and on
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the Environmental Protection Agency Web site at www. epa.gov/sunwise/uvindex.html. The FDA53 cautions that exposure doesn’t come only from above; snow, sand, water, and even concrete reflect UV rays. In addition, UVB is transmitted through clouds more readily than UVA. Although heavy cloud cover can almost completely block ultraviolet radiation, light cloud cover can allow significant amounts of UVB to penetrate. Thus, on some cloudy days, the combina- tion of direct and cloud-reflected radiation may provide geater exposure than occurs on days with clear sky. Sunlight is a major source of vitamin D for some people. (Ultraviolet rays trigger vitamin D synthesis when they strike the skin.) Because sunscreens interfere with sun exposure, there has been concern that they might contribute to vitamin D deficiency. Any such effect would probably be outweighed by the proven benefits of skin protection, and vitamin D supplements are always an option.
Tanning Devices Tanning at a salon or using a home tanning device is no safer than tanning in the sun. FDA regulations require that sunlamp products have a warning label, an accurate timer, and an emergency stop control, and that they include an exposure schedule and protective eyewear. Although the FDA permits tanning beds to be marketed, it advises that they be completely avoided.54 Spencer and Amonette55 state that the indoor tanning industry is a billion-dollar-a-year industry. After review- ing 118 studies on skin damage and indoor tanning, they concluded that tanning lamps can deliver two or three times the dose of UVA found in outdoor sunlight. They also noted that increasing numbers of melanomas are turning up in people younger than 40 who have used indoor tanning machines. A Consumer Reports inves- tigation found that many tanning-parlor operators tell patrons that they cannot burn or develop skin cancer as a result of using their device.7 FDA scientists have concluded that people who use sunlamps about 100 times a year may be increasing their exposure to “melanoma-inducing” radiation by up to 24 times the amount they would receive from sun exposure. (The amount would depend on the type of lamp used and whether a sunscreen product is used regularly.)56
Tanning Accelerators The cosmetic industry has marketed “tan accelerator” creams claimed to stimulate faster and deeper tans. Ty- rosine, the major ingredient, is naturally present in the
skin’s cells and is needed for melanin production. The companies claim that the tyrosine causes more melanin to form and that tanning therefore results. Skepticism is warranted because Jaworsky and others57 studied two brands of tanning accelerators in 18 volunteers and found no augmentation of tanning.
Sunless Tanning Sunless tanning products can give the skin a tanned look without exposing it to UV rays. Creams, gels, lotions and sprays are available for self-use, and spray-on tan- ning also is available at many salons, spas, and tanning businesses. The active ingredient in most products is dihydroxyacetone (DHA), which, when applied to the skin, reacts with dead cells in the outermost layer to tem- porarily darken the skin’s appearance. The coloring does not wash off but gradually fades as the dead skin cells slough—usually within a few days. The FDA58 advises consumers who seek spray-on tanning services to make sure that they are adequately protected from exposure to the eyes and mouth and from inhalation of the spray. Some “tanning pills” do not provide a tan but dye the skin orange or yellow by coloring the fat cells under the skin’s outer layer. The pills contain a food-coloring agent in doses much higher than the amount consumed in the normal diet. The skin color fades when the pills are no longer taken. One ingredient is beta-carotene, which is found naturally in many foods and is permitted as a color additive in foods and drugs. Another ingredient is canthaxanthin, a fat-soluble carotenoid that the human body cannot convert to vitamin A. Canthaxanthin is legal to use as a food-coloring agent. Despite a warning by the FDA, it has been ille- gally sold in tanning parlors and by mail as a tablet for skin tanning under such names as Orobronze, Darker Tan, French Bronze, and BronzGlo. Ads for Darker Tan promised “a rich dark bronze glowing tan without risking skin cancer.” A case has been reported of a 20-year-old woman who took high doses and developed aplastic anemia, a serious condition in which the production of blood cells is impaired. Previous reports have linked canthaxanthin use to hepatitis, generalized itching, hives, and eye problems.59
Two other types of “tanning” products are legally marketable as cosmetics. Bronzers, made from color additives, stain the skin but can be washed off with soap and water. Bronzers may produce different shades in dif- ferent areas of the body. Extenders, when applied to the skin, interact with a surface protein to produce color that tends to wash off after a few days. The only color additive
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approved for extenders is dihydroxyacetone. Although they give the skin a golden color, these products offer no sunscreen protection. The FDA requires that suntanning preparations that do not include a sunscreen ingredient carry the following statement on their labels:
Warning—This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn.
CamouFlage CoSmetiCS
Corrective cosmetics offer an alternative to surgery for the correction of various blemishes. They can be used to conceal birthmarks, broken capillaries, dark circles under the eyes, abnormal pigmentation, cleft lip defor- mities, varicose veins, stretch marks, scars, and other blemishes. They are also used to conceal bruising and other temporary after-effects of surgery. Concealers have an opaque foundation that makes them more effective than ordinary cosmetics for masking scars and other imperfections of the skin. Color correctors can be used to disguise discolored areas. Contouring products can be used to disguise swollen areas. Corrective cosmetics are waterproof and smudgeless and can adhere longer to the skin than ordinary cosmetics. However, they should be removed at night. The American Society of Plastic Sur- geons recommends that removal be done with a cleans- ing cream, followed by alcohol-free toner applied with a cotton ball, followed by application of a moisturizer.60
CoSmetiC proCedureS
The term “plastic surgery” refers to the repair or re- modeling of injured or defective body parts. The terms “cosmetic surgery” and “aesthetic surgery” refer to reshaping or remodeling of otherwise normal body features to improve a person’s appearance. The term “reconstructive surgery” means restoration of an in- jured, congenitally absent, or abnormal body feature. About 5000 physicians in the United State specialize in plastic and reconstructive surgery. Otolaryngologists, ophthalmologists, dermatologists, and general surgeons perform some plastic surgical procedures in the areas of the body within their scope. Most of the plastic surgery done by otolaryngologists is reconstructive. The cosmetic procedures done by plastic and recon- structive surgeons include breast augmentations, eyelid
surgery, face lifts, nose reshaping, liposuction, and about 20 other procedures. Some ophthalmologists perform eyelid tucks. The procedures done by dermatologists include hair transplants, dermabrasion, chemical peel- ing, laser procedures (to remove birthmarks, age spots, freckles, unwanted tattoos, and other types of blemishes), soft-tissue augmentation (to correct wrinkles and scars), and sclerotherapy (injection of a solution that will re- move unwanted veins near the skin surface). Table 18-2 describes the purpose, cost, side effects, risks, and duration of the results of 11 surgical proce- dures that plastic surgeons commonly perform. The cost of cosmetic surgery is not covered by most insurance policies and is not tax-deductible for federal income tax purposes.
Choosing a Plastic Surgeon The best choice for cosmetic surgery is a physician who has had special training in plastic surgery, has been certified by an appropriate specialty board, and has staff privileges at an accredited hospital. The American Board of Plastic Surgery (ABPS) requires at least 3 years of postgraduate training in surgery (or its equivalent), 2 years of postgraduate training in plastic surgery, 2 more years of experience, and passage of written and oral examinations. (The American Board of Facial Plastic and Reconstructive Surgery has a similar name but is not recognized by the American Board of Medi- cal Specialties.) The American Board of Dermatology and the American Board of Ophthalmology do not offer subspecialty certification in plastic surgery. Information about the relevant training and experience of dermatolo- gists or ophthalmologists can be obtained by contacting their offices. The American Society of Plastic Surgeons (ASPS) represents 97% of ABPS-certified surgeons. To deter the use of deceptive advertisements, it has developed a code of ethics for its members. Nevertheless, a panel of 50 consumers who used the code to rate 104 advertise- ments from the Yellow Pages of the 10 largest U.S. cities concluded that 25% of the ads used images that created unjustified expectations; 22% of the ads appealed pri- marily to fears, anxieties, or emotional vulnerabilities; and 18% were objectionable.61
The ASPS Web site (www.plasticsurgery.org) main- tains a directory of its members and the procedures they do. The certification status of other types of doctors is available from the American Board of Medical Spe- cialties Web site. Hospital privileges can be verified by contacting the hospital. Other sources are primary-care
Part Five Other Products and Services394
Procedure and Average Fee*
Abdominoplasty (tummy tuck) $5130 Botox injections
(eyes, forehead) $375
Breast enlargement
$3351
Breast lift $4207
Chemical peel $706
Collagen injections
$473 Dermabrasion $1200
Eyelid surgery $2828 Facelift $6231
Fat injection $1700
Liposuction $2884
Rhinoplasty $4306
Sclerotherapy $354
purpoSeS, riSkS, and 2009 FeeS oF SeleCted CoSmetiC SurgiCal proCedureS
Table 18-2
*Fees do not include the costs of anesthesia, operating room facilities, or other related expenses. The averages are based on a survey of members of the American Society of Plastic Surgeons.6 The cost of sclerotherapy depends on the area involved and the number of sessions required.
Purpose/Description
Flatten abdomen by removing excess fat and skin and tightening muscles
Botulinum toxin injections weaken muscles and reduce nearby wrinkles and frown lines
Enhance size and shape of breast using artificial implants
Raise and reshape sagging breasts by removing excess skin and repositioning remaining tissue and nipples
Restore wrinkled, blemished, unevenly pigmented, or sun-dam- aged facial skin using a chemical solution to peel away skin’s top layers
Plump up creased, furrowed, or sunken facial skin; add fullness to lips and backs of hands
Mechanical scraping of outer skin layers using a high-speed rotary wheel; lessens surface irregularities from acne, other scars, and fine wrinkles
Correct drooping upper eyelids and puffy bags below the eyes
Improve sagging facial skin, jowls, and loose neck skin by removing excess fat, tightening muscles, and redraping skin
Fat extracted from the patient’s abdomen, thighs, buttocks, or elsewhere is reinjected into the skin beneath the face
Reshape parts of body using tube and vacuum device to remove unwanted fat deposits that don’t respond to dieting and exercise
Reshape nose by reducing or increasing size, removing bump, narrowing span of nostrils, or changing angle between nose and upper lip
Lighten or shrink small superficial veins by injecting sclerosing material
Side Effects/Risks
Temporary discomfort; blood clots, infection, conspicuous scarring
Minimal; bruising and mild soreness may occur around injection site(s)
Temporary swelling and discomfort; infection; asymmetry; hardening of scar tissue around implant; rupture of implant; change in sensitivity of nipples or breast skin
Temporary swelling and discomfort; thick, wide scars; infection; per- manent loss of feeling in nipples or breast
Temporary swelling and discomfort; tiny whiteheads, infection, scarring
Temporary discomfort; allergic reac- tions, contour irregularities
Temporary swelling and discomfort; abnormal permanent color changes
Temporary swelling and discomfort; temporary blurred vision
Temporary swelling and discomfort; injury to nerves that control facial muscles and feeling; infection, scar- ring, asymmetry
Temporary swelling or puffiness; rare instances of infection
Temporary swelling and discomfort; infection, bagginess of skin, pigmen- tation changes
Temporary swelling and discomfort; infection; small burst blood ves- sels resulting in tiny but permanent red spots; incomplete improvement requiring additional surgery
Rare occurrence of blood clots in the veins, severe inflammation, allergy to the solution, scarring
Duration
Permanent
4 to 6 months but may last longer if muscle atrophies (thins)
Variable; implants may require removal or replacement
Variable; new sagging may occur; results may last longer if combined with im- plants
Permanent if phenol is used; variable with trichloroacetic acid
A few months to 1 year
Permanent, although new wrinkles may form as skin ages
Several years; some- times permanent
Usually 5 to 10 years
Effect usually is halved in 3-6 months but may persist for 1 year or longer
Permanent if person does not regain weight
Permanent
Vein obliteration is per- manent, but new veins may emerge
Chapter Eighteen Skin Care and Image Enhancement 395
physicians, operating room nurses, local hospital refer- ral services, and individuals who have had satisfactory surgery. Flamboyant advertising is not a favorable sign. Once names have been gathered, you might want to visit two or three surgeons for an initial consultation. That way you can compare their personalities, their opinions on the type of surgery you should have, their fees, and the way they answer your questions about the likely results and the risks. You can also ask how often the doctor has performed the procedure you are considering. Some doctors have photographs of their patients before and after surgery. Although they may be useful, Lorenc62 has pointed out that pictures can be digitally enhanced and that meeting actual patients might be more instructive. Even if the surgeon would like to do a contemplated procedure on an outpatient basis, it would be prudent to check whether the physician has been approved for performing that procedure at the hospital. The FTC63
has advised consumers to be wary of physicians who suggest “fixing” a feature that does not bother you, use a hard sell to obtain your business, or brush aside your concerns about safety.
Injectable Products for Image Enhancement The FDA has approved several injectable products that licensed practitioners can use to treat fine lines, wrinkles, and scars.64 Their effectiveness lasts from about 3 months to 1 year. The most widely used is botulinum toxin type A (Botox Cosmetic), a protein complex produced by the bacterium Clostridium botulinum. (This is the same toxin that causes the type of food poisoning called botulism.) When injected, small doses of the toxin block the release of a chemical (acetylcholine) by nerve cells that signal muscle contraction. By selectively interfering with the ability of underlying muscles to contract, frown lines are smoothed out and, in most cases, are nearly invisible in a week, an effect that typically lasts 4 to 6 months. Botox Cosmetic is approved for temporary improvement in the appearance of moderate-to-severe frown lines between the eyebrows in people 18 to 65 years of age. The FDA recommends that it be injected no more than once every three months and that the lowest effective dose should be used. Physicians are also using Botox Cosmetic to treat wrinkles in the neck and other parts of the face. However, the safety and effectiveness of this “off-label” use have not been reviewed by the FDA or clinically evaluated. Some practitioners buy the toxin in bulk and arrange gatherings where groups of people receive their treat- ment at a discounted cost. The FDA65 is concerned that
these “Botox parties” violate label instructions that—to maintain sterility—restrict their use of each bottle for only one person. The agency has also received reports that unqualified people are administering Botox Cos- metic in salons, gyms, hotel rooms, home-based offices, and other retail venues. In such cases, recipients run the risks of improper technique, inappropriate dosages, and unsanitary conditions. If too much toxin is injected, for example, or if it is injected into the wrong facial area, a person can end up with droopy eyelid muscles that could last for weeks. Even with proper technique, adverse effects can include headache, respiratory infection, flu syndrome, nausea, facial pain, redness at the injection site, and muscle weakness. These reactions are generally temporary, but some can last for several months. It is important to be sure that a qualified doctor per- forms the procedure in a medical setting that uses proper sterile techniques. The need for caution is illustrated by a recent case in which an unlicensed osteopathic physi- cian and three others whom he injected were hospital- ized with symptoms of botulism, a muscle-paralyzing disease. Investigators found that the drug used at the clinic was far more potent than Botox Cosmetic and lacked FDA approval.67 Other cases have been reported in which beauty salon personnel offered botulinum toxin injections, collagen injections, laser treatments, chemical peels, and microdermabrasion while failing to operate under medical supervision as advertised.68 Several injectable products have been approved as medical devices to help fill in facial wrinkles.69 The
√ Consumer Tip
Be Wary of Mesotherapy Mesotherapy is claimed to permanently remove fat and improve body contours. Touted as a nonsurgical alter- native to liposuction, mesotherapy involves injecting medications and plant extracts into layers of fat and connective tissue under the skin. The injected ingre- dients may include agents that are used to open blood vessels, nonsteroidal anti-inflammatory medications, enzymes, nutrients, antibiotics, and hormones. It may be used together with dietary modification, hormone replacement therapy, exercise, and nutritional supple- ments. It typically costs $1000 to $1500 per treatment, with 3 to 6 treatments required. The American Society of Plastic Surgeons66 has warned that no well-designed studies demonstrate that mesotherapy is safe or ef- fective, removes fat from the body, or provides any permanent benefit.
Part Five Other Products and Services396
approved ingredients include collagen injections, hy- aluronic acid gel, calcium hydroxyapatite, and poly-L- lactic acid (PLLA) which are absorbable and considered temporary because they are eventually absorbed. There is also a permanent (non-absorbable) filler that consists of polymethylmethacrylate beads (PMMA microspheres), which FDA deems biocompatible. Most side effects occur shortly after injection and go away within seven days but sometimes they emerge weeks, months, or years later. A nonabsorbable filler can cause long-term side effects. The FDA advises against using wrinkle fillers to plump the lips, increase breast size, or implant into bone, tendon, ligament, muscle, or blood vessels. Consumers who seek wrinkle treatments should read the FDA literature and discuss the potential risks as well as benefits with a qualified practitioner. Referrals can be obtained through the Web sites of the American Academy of Dermatology and the American Society for Aesthetic Plastic Surgery.
Contour Reshaping Devices In recent years, many doctors have been advertising nonsurgical cosmetic procedures that are claimed to tighten skin and/or get rid of underlying fat. During the last decade, the FDA has cleared many devices that are said to (a) kill fat cells by freezing them, (b) kill fat cells by heating them, and/or (c) smooth and soften the skin and reduce wrinkles by using a laser or radio frequency waves to strengthen or stimulate the growth of collagen (fiber under the skin).73 These devices have not been studied enough to determine their effectiveness or comparative effectiveness.
Phototherapy for Vascular Marks Laser devices can deliver very brief bursts of pulsed light to remove vascular birthmarks, spider veins (clusters of small superficial veins)74 on the legs and face, and other small vascular conditions. The operator holds the treat- ment unit on the patient’s skin. Usually four or more treatment sessions are required. The light coagulates the small blood vessels, which are sealed off and gradu- ally fade away. There may be slight reddening or local swelling for a few days. Other temporary side effects, which are rare, include blistering, burning, or changes in skin color. The technology is not suited for larger blood vessels, which may burst. These require sclerotherapy. Lasers deliver light at a single wavelength (wave- length determines color), which enables them to target tissues that absorb that particular color. Lasers that deliver in the “red” range, for example, are useful for destroying blood vessels, because they target hemoglo-
Personal Glimpse
Questionable Facelift Claims
The American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery have jointly issued a position statement70 warning against the use of stem cell procedures for cosmetic purposes. The statement warns:
• Many procedures are advertised by practitioners who were not trained in residency programs de- signed to teach the physician safe and careful evalu- ation of cosmetic patients or a working knowledge of the full range of aesthetic procedures.
• Stem cell harvesting equipment that lacks FDA ap- proval is being marketed to physicians.
• The use of stem cell procedures in aesthetic surgery is not adequately supported by clinical evidence.
In 2010 the Los Angeles Times71 described how two surgeons used liposuction to collect fat from the patient, separate and concentrate the stem cells, add them back to the fat, and inject the stem cell-enriched fat into locations on the patient’s face. But the chairman of the ASPS/ASAPS position paper task force said that (a) nobody really knows how the stem cells themselves are behaving, (b) fat injections alone can improve a person’s appearance (no stem cells are needed), and (c) long-term effects of the procedures are unknown. Google searches for “stem cell facelift” and “stem cell breast augmentation” yield hundreds of thousands of links. Lifestyle Lift, headquartered in Troy, Michigan, operates about 40 plastic surgery clinics throughout the United States that specialize in doing facelifts. In 2009, without admitting or denying fault, the company agreed to pay $300,000 in penalties and costs to New York State and to discontinue promoting its services in ways that the state attorney general had challenged.72 The facelift procedure offered at the clinics is described as less expensive and less invasive than traditional face- lift surgery. As the company became established, many patients who had used its services posted unfavorable comments on independent review Web sites. The at- torney general charged that in an attempt to promote and protect its reputation, the company (a) regularly and systematically posted positive stories to these sites by having people pose as independent and satisfied customers and (b) created and controlled sites where it posted favorable comments without disclosing that it owned these sites. In September 2011, the Better Business Bureau gave Lifestyle Lift a B+ rating and reported that during the previous three years, 32 people had complained about problems with its services and 6 had complained about advertising, sales, billing, or collection issues.
Chapter Eighteen Skin Care and Image Enhancement 397
bin’s red color. Other lasers target black pigment in hair or tattoo dyes. Intense pulsed light devices use filters to produce similar wavelengths. They come close to what a laser can do but are not as accurate. Laser and pulsed light treatments are also claimed to “rejuvenate” skin by increasing collagen growth in response to thermal injury by the light. These claims have not yet been tested in long-term studies.
Breast Implants Breast implantation surgery is available to increase the size of the breasts or to reconstruct a breast after breast- cancer surgery. The most common types of implants are sacs filled with saline (dilute salt water) or silicone gel. They vary in size, shell thickness, and shape. The risks of implant surgery include hardening of the breast caused by scar-tissue formation, leakage or rupture of the implant, temporary or permanent loss of sensation in the nipple or breast tissue, pain caused by calcium deposits, shifting of the implant, inability to breast-feed; and interference with the ability to detect cancer through mammography. Lorenc62 advises women to be careful that the final breast size the surgeon has in mind is what they want. Breast implants last for many years in some women, whereas in others frequent replacement seems neces- sary. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience local complications or adverse outcomes. As many as 1 in 5 primary augmentation patients and 1 in 2 primary reconstruction patients require implant removal within 10 years. The most frequent reasons for removal are capsular contracture, rupture, malposition, and wrinkling or ripping.75
Until 1992 most of the implants were filled with silicone, and about 10% contained saline. Silicone was generally preferred because it gives the breast a more natural look and feel. (Silicone implants differ from
silicone injections, which allow the liquid silicone to spread to the surrounding tissues.) In 1992, after receiving many thousands of re- ports of adverse reactions, the FDA halted the use of silicone-filled implants except for reconstructive breast surgery and certain medical conditions—provided that the patient was enrolled in a clinical study. Saline-filled implants remained available. The FDA considers these less risky because, although they have the same silicone rubber envelope as gel-filled implants, leakage or rupture would release only salt water, not silicone gel, into the tissues. In 2006, after several studies were completed, the FDA approved two brands of silicone implants for augmentation (for women at least 22 years old) as well as for reconstruction. During 2010, there were 96,203 breast augmentation procedures and 93,083 breast reconstruction procedures performed in the United States with about half using each implant type.76 Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labeled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Further infor- mation is available at www.fda.gov/breastimplants.
Other Cosmetic Breast Surgery Breast-lift surgery (mastopexy) raises and firms the breasts by removing excess skin and tightening the sur- rounding tissue to reshape and support the new breast contour. This operation does not change breast size. Breast-reduction surgery (mammaplasty) removes excess breast fat, glandular tissue, and skin to achieve the desired breast size. It may be appropriate for women with unusually large, pendulous breasts who suffer emo- tionally or experience back pain, neck, or shoulder pain due to the weight of the breasts.
Suppose you are dissatisfied with your appearance and think it may hamper your social success. Check which of the following actions you would take.
Discuss the situation with a friend _______________________ Discuss the situation with a parent _______________________ Consult your family doctor or a student health physician _______________________ Consult a professional who counsels people about their appearance _______________________ Consult a dermatologist or plastic surgeon _______________________ Other (specify) _______________________________ _______________________
It’s Your Decision
Part Five Other Products and Services398
boguS breaSt and peniS enlargement ClaimS
Many pills, potions, and devices are marketed with false claims that they significantly and permanently enlarge the breast or penis. ConsumerLab.com,77 which evaluates the quality of herbal and dietary supplement products, has concluded that “natural products” marketed for breast enhancement are not effective. Its review found no published double- blind studies or a sound theoretical basis to conclude that any of 20 commonly used ingredients are effective. The review stated, for example, that estrogenic herbs (including soy, red clover, fennel, and hops) do not in- crease breast size in premenopausal women and could theoretically decrease it, although most are probably too weak to have any effect. One of the most heavily promoted was Bloussant, an herbal product that contained saw palmetto, fennel seed, dong quai, damiana, blessed thistle, dandelion, watercress, black cohosh, and wild yam. Its marketers claimed that the product would “regenerate the growth process,” “would increase the bustline by one-half to two cup sizes in just 2 weeks,” and was an alternative to breast surgery. In 2003, the marketers signed a consent agreement under which they paid $3.2 million and were barred from making unsubstantiated claims.78
Vacuum devices have also been falsely claimed to increase breast size. In 2001, the Iowa Attorney General obtained an injunction barring New Womyn and its president, Dan Kaiser, from marketing their “Stimula- tions VII” within or from the state of Iowa. The product included a dome that fit over the breast and a vacuum pump said to create suction on the skin surface. Dr. Stephen Barrett,79 who provided expert testimony in the case, said:
Applying a vacuum to the outside of the breast might slightly stretch tissue on the surface, but it will not change the shape of cells below the skin. . . . In order to achieve true enlarge- ment, the glandular and fatty tissue inside must increase. This can only occur with cell growth in either number or size. . . . I don’t see how a vacuum device would result in long-term changes to the breast that will increase its size. There may be some short-term changes in the skin, but they are unlikely to be permanent.
In 2003, Vincent J. Passafiume, Michael A. Consoli, and Geraldine Consoli (Michael’s mother) signed a con- sent agreement with the Arizona Attorney General under which they forfeited about $35 million in seized prop- erty. Operating as C.P. Direct, Inc., the trio had falsely claimed that their product Longitude would permanently
enlarge the penis by 1 to 3 inches; that Stature would permanently increase height by 1 to 4 inches; and that Full and Firm capsules would increase female breast size by 2 to 3 cup sizes. Documents in the case indicate that the “before-and-after” photographs had been copied from a competitors’ Web site and had no connection with the defendants’ products.80
Sales of alleged breast and penis enlargement prod- ucts are fueled by feelings of inadequacy. Individuals who feel impelled to try them would be wiser to discuss their concerns with a knowledgeable professional.
Cosmetic Phalloplasty Phalloplasty (penis reconstruction) has medical usage in cases of injury or birth defects, but cosmetic procedures are another matter. The Medical Letter81 warns that phal- loplasty procedures for patients with normal anatomy have not been proven effective, have a high complication rate, and are generally disappointing because (a) pain, bruising, swelling, and infection have occurred, with skin and urethral damage; (b) cosmetic complaints have included hypertrophic scars and shortening of the penis due to fibrosis; (c) fat injections have left painful residual nodules; (d) the complications of cavernous grafting have included shaft deformities, erectile dysfunction, and decreased sensation; and (e) some patients have required reconstructive surgery for these complications. The report also noted that procedures that can lengthen the penis 2 to 3 inches in the flaccid state do not make it bigger when erect. In 1996 The Wall Street Journal82 reported that 20 to 30 surgeons were performing many operations pur- ported to enlarge the penis permanently. About half of
Figure 18-2. Ad for dubious penile surgery, 1994.
Chapter Eighteen Skin Care and Image Enhancement 399
these surgeons were located in Southern California. The operation is done by cutting an internal attachment of the penis to the pubic bone, which causes more of the organ to protrude. Fatty tissue injections and grafts have been used to enlarge penile girth. The American Urological Association states that these procedures have not been proven safe or effective.83
Figure 18-2 shows an advertisement that offered a “free 20-minute consultation” for penis surgery. In January 1994, after spotting the ad, Dr. William M. London posed as a prospective patient. The “consul- tation” was performed by the surgeon’s stepson, who had had no medical training. The stepson said that the lengthening procedure usually added 2 to 2.75 inches and had no health risks except “minor infections at the area worked on.” London also noted that no attempt was made to explore whether it was sensible for him to have the operation. The Wall Street Journal’s report stated (a) this doctor had performed 6 to 14 operations a day and had grossed $7.4 million during the first 6 months of 1994 and (b) more than 50 malpractice suits had been filed against him by patients who said they had suffered great pain, been disfigured, been rendered impotent, or had other serious complications. Charged with unprofes- sional conduct, the doctor permanently surrendered his medical license in 1996. Payments in the malpractice suits exceeded $6 million.
SummarY
Consumers spend over $30 billion yearly on skin care and beauty aids that may help their appearance but will not perform miracles. Much of this expense occurs because our youth-oriented culture prods people to try to look younger. For cosmetic products, price is generally not a reliable indicator of quality. Soaps and various cosmetic products can help keep the skin clean, moist, and soft. But no cosmetic can eliminate wrinkles, repair sun-damaged skin, or retard or reverse the aging process of the skin. Mild cases of acne can be improved through hygienic practices and generally can be treated with OTC products. Severe conditions should have professional assistance. The three most important things you can do for your skin are (1) keep it clean, (2) protect it from the sun, and (3) don’t smoke cigarettes. Cosmetic surgery can improve many people’s ap- pearance. Consumers contemplating cosmetic surgery should investigate thoroughly to determine the potential benefits, the risks, and the surgeon’s credentials. Pills, potions, and vacuum devices claimed to per- manently enlarge the breasts or penis are bogus.
reFerenCeS
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2. Begoun P. Don’t Go to the Cosmetics Counter Without Me: An Eye Opening Guide to Brand Name Cosmetics, ed 2. Seattle, 1994, Beginning Press.
3. Caplan A. Quoted in Springen A. Health: Kids under the knife. Newsweek, Nov 1, 2004.
4. Solving problems related to the use of cosmetics and skin care products. Schaumburg, Ill., 2005, American Academy of Der- matology.
5. U.S. sales of cosmetics, toiletries rise above pre-recession levels. Drugstore News, May 4, 2011.
6. Report of the 2010 plastic surgery statistics. Chicago, 2011, American Society of Plastic Surgeons.
7. Indoor tanning: Unexpected dangers. Consumer Reports 70(2):30–35, 2005.
8. Stehlin D. Cosmetic safety: More complex than at first blush. FDA Consumer 25(9):18–23, 1991. (Revised 1995.)
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10. Coming clean on bath soap. Consumer Reports 66(10):32, 2001. 11. Triclosan: What consumers should know. FDA Web site, April
8, 2010. 12. Hand sanitizers carry unproven claims to prevent MRSA infec-
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latest on which products moisturize best. Consumer Reports 65(1):38–41, 2000.
15. Smith JB, Fenske NA. Cutaneous manifestations and con- sequences of smoking. Journal of the American Academy of Dermatology 34:717–732, 1996.
16. Kadunce DP and others. Cigarette smoking: Risk factor for premature facial wrinkling. Annals of Internal Medicine 114:840–844, 1991.
17. Winter R. Do antiaging creams really work? Consumers Digest 33(4):61–64, 1994.
18. Kurtzweil P. Alpha hydroxy acids for skin care. Smooth sailing or rough seas? FDA Consumer 32(2):30–35, 1998.
19. Can soaps do more than clean? Consumer Reports 61:730–733, 1995.
20. Foulke JE. Cosmetic ingredients: Understanding the puffery. FDA Consumer 26(4):11–14, 1992.
21. Hall H, Barrett S. A skeptical view of the Perricone prescription. Quackwatch Web site, Aug 12, 2004.
22. Cosmeceuticals. American Academy of Dermatology Web site, accessed Sept 29, 2011.
23. Collins BB. Warning letter to Dennis Gay, Jan 20, 2005. 24. Renova: Wrinkle cream or skin game? Consumer Reports on
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Part Five Other Products and Services400
31. Parikh R. Proactiv’s celebrity shell game. Salon.com, Feb 28, 2011.
32. “Acne Cure” mobile app marketers will drop baseless claims under FTC settlements. FTC news release, Sept 11, 2011.
33. Begoun P. Don’t Go Shopping for Hair-Care Products Without Me. Renton, Wa., 2004, Beginning Press.
34. Shampoos: Head games are a lot of lather. Consumer Reports 65:18–23, 2000.
35. Hingley AT. Controlling dandruff. FDA Consumer 28(8):25–27, 1994.
36. Mayfield E. Psoriasis treatments: Relieving that terrible itch. FDA Consumer 29(3):12–15, 1995.
37. Laser hair removal. American Academy of Dermatology Web site, accessed Oct 17, 2011.
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39. Callender VD, Onwudiwe O. Prevalence and etiology of cen- tral cicatricial centrifugal alopecia. Archives of Dermatology 147:972–974, 2011
40. FDA approves Rogaine for OTC marketing. FDA Talk Paper T96-9, Feb 12, 1996.
41. Finasteride and minoxidil for alopecia. The Medical Letter 47:95–96, 2005.
42. Hair replacement procedure steps. American Society of Plastic Surgeons Web site, accessed Oct 17, 2011.
43. Barrett S. Be wary of Gero Vita, A. Glenn Braswell, and Bras- well’s ‘Journal’ of Longevity. Quackwatch Web site, Oct 17, 2011.
44. Court order brings to a close FTC lawsuit against makers of “Helsinki Formula” for its baldness cure claims. FTC news release, Feb 12, 1997.
45. Television “Home Shopping” retailer settles FTC charges that advertising claims lacked scientific support; will offer refunds. FTC news release, July 11, 2001.
46. Think before you ink: Are tattoos safe? FDA Consumer update, Nov 17, 2008.
47. Position statement on body piercing. Schaumburg, Ill., 1998, American Academy of Dermatology.
48. Best way to keep bugs away. Consumer Reports 76(7):11, 2011 49. Drug products containing active ingredients offered over-the-
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50. DeSimone EM II. Sunscreen and suntan products. In Handbook of Nonprescription Drugs, ed 10. Washington, D.C., 1993, American Pharmaceutical Association.
51. American Cancer Society. Cancer Facts & Figures 2011. Atlanta, 2011, American Cancer Society.
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54. Strange CJ. Thwarting skin cancer with sun sense. FDA Con- sumer 29(6):10–14, 1995.
55. Spencer JM, Amonette RA. Indoor tanning: Risks, benefits, and future trends. Journal of the American Academy of Dermatology 33:288–298, 1995.
56. Kurzweil P. Seven steps to safer sunning. FDA Consumer 30(5):6–11, 1996.
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68. Siwolop S. That quest to enhance beauty can leave scars. The New York Times, July 14, 2002.
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statement, Oct 2008.
Chapter Nineteen
Sexual and RepRoductive HealtH
For more than 50 years, since the successful synthesis of estrogens and progestins, safe and effective pregnancy prevention has been possible. Nonetheless, in the United States an estimated 3.5 million unwanted preg- nancies occur annually, one third of which involve teenagers.
iris f. litt, m.d.1
A good diet and a regular exercise program are a more dependable path to better sex than are goats’ eyes, deer sperm, and frogs’ legs.
tamar NordeNberg2
Think of your bones as a retirement account: They’re where you stash cal- cium when you’re young, so you’ll have enough to last through old age.
CoNsumer reports3
© glasbergen
“Let’s play doctor. I’ll give you my list of ailments and you blame it all on my hormones.”
Part Five Other Products and Services402
This chapter discusses many of the products, ser- vices, and self-care concerns related to sexual and reproductive function and activities. It includes
more for women than for men, but most of it is relevant to both. The topics include menstrual products and prob- lems, feminine hygiene, vaginitis, “jock itch,” sexually transmitted diseases, contraception, induced abortion, pregnancy testing, infertility services, prenatal care, birthing, delivery options, hormone-replacement therapy, osteoporosis, erectile dysfunction, and dubious sex aids.
MenStRual pRoductS
Menstruation takes place approximately once a month as the uterus sheds the vascular lining it has prepared in response to the woman’s hormones. The debris exits through the vagina over several days. Most women use tampons or pads to dispose of the menstrual fluids. Menstrual cups are another option. An effective tampon is absorbent enough to protect against leaks, but not so absorbent that it dries out the delicate vaginal tissues. It should also be easy to insert, comfortable to wear, and easy to remove. It may help to use a more absorbent one when menstrual flow is heavy and a less absorbent one when flow is light. Using a highly absorbent tampon when flow is light may result in excess absorption of natural vaginal lubrication. Excessive drying of the vaginal tissue can increase the risk of vaginal infection and susceptibility to toxic shock syndrome (TSS), a rare but potentially fatal infec- tion caused by Staphylococcus bacteria. TSS is charac- terized by high fever, vomiting, diarrhea, sunburnlike rash, liver or kidney failure, and a rapid blood pressure drop that can cause shock. In 1989 the FDA ordered manufacturers to standardize tampon labeling so that “junior,” “regular,” “super,” and “super plus” means the same thing regardless of a manufacturer’s brand.
• People who wish to use contraception should consider effectiveness, convenience, safety, protection against sexually transmitted diseases (STDs), and personal and partner preferences.
• Prenatal care that includes abstaining from alcohol and tobacco, sensible eating, regular exercise, close cooperation with a trusted physician, and other childbirth education activities can greatly benefit both mother and child.
• The risk of osteoporosis, a serious condition, can be greatly reduced by minimizing risk factors throughout life.
• Hormone replacement therapy is effective in managing menopause symptoms and preventing osteoporosis but entails risks that, in many women, may outweigh the benefits.
• Treatments are available for infertility and erectile dysfunction, but effective treatments tend to be costly and bogus treatments are widely promoted.
Keep tHeSe pointS in Mind aS You StudY tHiS cHapteR
Key Concepts
Packages must explain the basis for the rating and advise on choosing the lowest appropriate absorbency.4 A 1994 study by Consumer Reports found that most tampons absorbed amounts within their labeled range.5
Menstrual cups6 are placed in the vagina to capture the menstrual fluid and hold it until the woman removes and empties the cup. The most common type is bell- shaped and can be reused for many years. The other type, which resembles a contraceptive diaphragm, is intended for one-time use. Neither type is effective as a contraceptive device.
Tips to Prevent Toxic Shock Syndrome • Wash hands with soap and water before and after
inserting or removing a tampon. Use care to avoid carrying bacteria from the skin or rectum into the vagina.
• Choose the lowest absorbency product that is effective.
• Do not use a plastic applicator that may be more likely to scratch the vagina. Cardboard applicators tend to be gentler. On days when secretions in the vagina are scanty, use a water-soluble lubricating jelly on the tampon applicator to avoid nicking the vaginal surface.
• Change tampons often—at least as frequently as every 6 to 8 hours.
• Alternate tampon use with pads during a given menstrual period. Do not use a tampon on days when bleeding is light.
• If symptoms of high fever (102.7°F or higher), vomiting, diarrhea, or sunburnlike rash occur, discontinue tampon use and immediately consult a physician.
√ Consumer Tip
Chapter Nineteen Sexual and Reproductive Health 403
MenStRual pRobleMS
Many women who menstruate experience significant symptoms before or during their monthly periods. Symp- toms fall into three general categories: dysmenorrhea (painful menstruation), premenstrual syndrome (PMS), and menstrual irregularities.
Dysmenorrhea Dysmenorrhea is typically experienced as cramplike lower abdominal discomfort that may come and go in waves. There may also be dull lower backache and, in some women, nausea and vomiting. These symptoms begin shortly before the onset of menstrual flow and usually last 2 or 3 days. A small percentage of women have symptoms severe enough to interfere with their usual activities. Dysmenorrhea may be primary or secondary. Primary dysmenorrhea, by far the more common type, begins during the first year or two after the onset of menstruation, usually lasts only a few years, and is dramatically relieved after childbirth. Self-treatment with a nonprescription pain reliever may be effective when started the day before a menstrual period. (See Chapter 17 for dosage information.) Primary dysmenorrhea does not usually require consultation with a physician unless symptoms are severe and do not respond to self-treatment. The most commonly prescribed drugs are NSAIDs (nonsteroidal antiinflammatory drugs) and oral contraceptives (par- ticularly for women who also want contraceptive protec- tion). Secondary dysmenorrhea refers to menstrual pain that develops in women who previously had little or no cramping with their periods. It is usually associ- ated with an abnormality of the reproductive organs such as a benign uterine tumor (polyp or fibroid), a pelvic infection, or endometriosis. It can also be caused by an intrauterine device (IUD) used for contraception. A physician should be consulted in all cases of secondary dysmenorrhea to determine the presence of any underlying disease that requires treatment. In most cases, medical treatment will be more effective than self-treatment.
Premenstrual Syndrome Premenstrual syndrome (PMS; also called premenstrual tension) is a combination of physical and/or emotional symptoms that occur a week or two before menstrua- tion and disappear or become minimal during periods. PMS is said to be very common, but estimates of its incidence are clouded by lack of a precise definition. The symptoms vary from person to person but are usu- ally consistent for each individual; they include tension,
depression, irritability, fatigue, difficulty concentrating, crying spells, aggression, headaches, abdominal bloat- ing, swelling of the hands and feet, breast tenderness, constipation, acne, abnormal thirst, and cravings for sweets and/or salty foods. Usually relief occurs when the menstrual period begins. In contrast to dysmenorrhea, PMS usually starts during the late 20s or 30s and worsens with age and after childbearing. When symptoms include depression and are severe enough to interfere with oc- cupational and social functioning, the condition is called premenstrual dysphoric disorder (PMDD). Most women with PMS do not need treatment by a physician. Only symptoms that disrupt their life need medical intervention. Understanding what occurs in the body when symptoms are present often provides signifi- cant relief. The following suggestions may also help:
• For premenstrual water retention (abdominal bloating and swelling of the hands and feet), refrain from adding salt to meals and restrict sodium-containing foods from a few days before the time of the menstrual cycle when the symptoms typically occur until the time they go away. Diuretic drugs may be helpful.
• Cut down on alcohol, coffee, tea, cocoa, cola, and other foods and medications that contain caffeine or related compounds. Although this may not help, it is harmless and relatively easy to do.
• Try to identify and deal with psychosocial stresses. • If eating sweets appears to produce symptoms, try to satisfy
cravings with complex carbohydrates rather than simple sugars that tend to produce greater variability of blood sugar levels.
• Beginning a program of regular exercise often reduces the severity of symptoms.
Over-the-counter (OTC) products for premenstrual discomfort contain one or more of up to four main ingre- dients: a pain reliever, a diuretic, an antihistamine, and caffeine. OTC diuretic ingredients are weak compared to those available by prescription, but they may relieve the symptoms of PMS by helping the body shed water. Some doctors recommend pyridoxine (vitamin B6) for PMS. Many years ago an FDA advisory panel con- cluded that pyridoxine had not been proven effective. Subsequent reports of nervous system toxicity indicate that pyridoxine supplementation is unsafe (see Chapter 11). Other supplementary vitamins were summarily disapproved by the expert panel. Anything that interrupts the hormonal ups-and- downs of the menstrual cycle can dramatically relieve PMS/PMDD symptoms. Most commonly, birth control pills are used. These can also be taken on an “extended cycle” basis to reduce the frequency of periods. One birth control pill, Seasonale, has been specifically approved by the FDA to be taken this way.
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A Cochrane review has concluded that selective serotonin reuptake inhibitors (SSRIs) are highly ef- fective against PMS and PMDD.7 These products are prescription drugs that raise the level of serotonin in the brain. Serotonin is an organic compound involved in the transmission of impulses between nerve cells and in the regulation of cyclic body processes. The most commonly used SSRI is fluoxetine, which is marketed as Prozac and a generic version for depression and as Sarafem for PMDD.
Menstrual Irregularities During the first few years of menstruation, irregularity is common and is thought to be related to immaturity of the pituitary-ovarian system. The treatment of abnormal uterine bleeding depends on the cause, the woman’s age, and her plans regarding pregnancy. Persistent menstrual irregularity at any age or excessive bleeding after age 35 are reasons to consult a physician. Bleeding for longer than 7 days is considered excessive and warrants evalu- ation by a physician, as does bleeding between periods or after intercourse. Bleeding that occurs 1 year or more after menstrual periods cease (postmenopausal bleed- ing) should be evaluated promptly, because it may be a sign of cancer. Both medical and surgical treatments are available for heavy bleeding due to other causes.8
Women normally lose 1 to 4 tablespoons of blood during a menstrual period, with a daily iron loss of up to 1.4 mg. This amount of iron can be replenished by sensible eating. Individuals with a heavy blood flow (which may result in clots) should be sure that their iron intake is adequate. This can be accomplished by eating iron-rich foods (e.g., liver, veal, other meats, fish, soy- beans), cooking in an iron pot, or using iron supplements. However, self-medication with supplementary iron is unwise unless a deficiency is medically diagnosed with a blood test (see Chapter 17). Even if an individual is iron-deficient, the cause should be established before treatment is begun. To avoid iron overload, women who have stopped menstruating because of contraceptive use or a surgical procedure should not take iron-containing supplements—including some labeled “especially for women.”
vaginal HYgiene
Under normal circumstances the healthy vagina cleans itself. Like the eyes, nose, and mouth, it is lined with epithelial cells that produce secretions that flush surface debris toward the outside. At the same time, bacteria normally present maintain the normal acidity of the
vagina, which discourages the growth of other micro- organisms.
Douching Douching consists of forcing water or other fluids into the vagina for “cleansing” purposes. Except for douches prescribed for treating medical problems, douching is unnecessary and may be harmful. Many preparations cause drying of the vaginal tissues and disturb the nor- mal bacteria that help to keep the vagina healthy. Some products contain local anesthetics (e.g., phenol, menthol) that can mask symptoms of infection. Reusable douching materials carry added dangers. Douching within 3 days before a pelvic examination or Pap smear can interfere with the accuracy of these procedures. Douching should never be done during pregnancy or within 6 weeks after giving birth or having a miscarriage. The FDA, which classifies douches as cosmetics, requires that they be labeled: “For cleansing purposes only. Do not use more than twice weekly unless directed by a physician,” or “For cleansing purposes only, after menstruation and after marital relations.” However, it should be noted that postcoital douching is not an ef- fective contraceptive.
External Hygiene Vaginal secretions and perspiration can collect on the ex- ternal surfaces of the vaginal folds, where they can break down and become odorous if allowed to accumulate. This is more likely to happen with the use of pantyhose and nylon panties, which increase the accumulation of perspiration. These garments should be washed after each use in mild, nonperfumed soaps. If pantyhose are used, those with a cotton crotch are less apt to allow the buildup of heat and moisture. Washing the skin of the vulva is all that is needed for adequate hygiene. Care should be taken to avoid getting soap on the delicate tissue at the entrance of the vagina and the urethra (where the urine exits the blad- der). So-called feminine deodorant sprays are unneces- sary and can cause trouble not only for product users but also for their sexual partners. Some women who have used these products have experienced infections, irritations, burns, and rashes. Women who decide to use a spray despite these facts should follow the manufac- turer’s directions carefully. The FDA requires a label warning that includes:
Do not apply to broken, irritated, or itching skin. Persistent unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.
Chapter Nineteen Sexual and Reproductive Health 405
vaginitiS
Vaginitis means inflammation of the vagina. It is often accompanied by vulvitis, an inflammation of the outer tissues of a woman’s genital area, in which case the problem is called vulvovaginitis. Most women have vaginitis at some time during their life. The symptoms are vaginal discharge with or without itching, burning, odor, or burning with urination. The most common causes of vaginitis and vulvitis are chronic irritation by bacteria or yeast (Candida albi- cans and sometimes other species). These microorgan- isms are normally present in small numbers but are kept in check by certain strains of lactobacilli, the bacteria that dominate the vagina and produce lactic acid and other substances that maintain a low (acidic) pH in the vagina. Anything that disturbs these bacteria or reduces their numbers can provide the opportunity for yeast overgrowth. This includes douching, sprays, heat and moisture buildup from clothing, irritants in spermicides and some condoms, soaps, tissues, swimming pool water, antibiotics, “lost” tampons, and even high fevers from other illnesses. Women with diabetes are more vulner- able to vaginitis, especially vaginal yeast infections. The introduction of fecal bacteria into the vulvar and vaginal areas by sexual practices or poor hygiene can cause infections. Vaginitis and vulvitis are also caused by sexually transmitted organisms such as Trichomonas vaginalis and the herpes virus. Rarely, overgrowth of the normal lactobacilli causes similar symptoms. Some of the aforementioned agents can also irritate the vaginal tissues without causing an infection. The treatment of vaginitis and vulvitis depends on the cause. Nonprescription products that are effective against yeast contain an antifungal drug (clotrimazole, miconazole, butoconazole, or tioconazole). Those that contain benzocaine (a local anesthetic) may temporarily relieve symptoms of burning and itching until a physician can be consulted. Homeopathic products, which contain no actual antifungal agent, are worthless for treating yeast infections, yet some pharmacies display them adjacent to approved OTC products. Trichomoniasis is usually curable with a single dose of a prescription drug but both sexual partners should be treated so the causative organism (a parasite) is eliminated.9 There is no scientific evidence that dietary factors play any role in the cause or treatment of vaginitis. Theoretically, treatment with the right strains of lacto- bacilli could be helpful, especially for preventing yeast infections. However, the research carried out so far on acidophilus and other probiotic preparations has been inconclusive.10
Because vaginitis and vulvitis have many causes, some of which are serious, a doctor should be consulted unless a woman is certain that she has a recurrence of a previously medically diagnosed problem that is suitable for self-treatment. In some cases, treatment of a woman’s sexual partner(s) is also necessary.
“JocK itcH” “Jock itch” is a rash in the groin caused by a fungal infection. It is more common in men than in women. Its symptoms include itching, burning, and stinging of the skin. Several organisms can cause it, but the most common is the same one that causes athlete’s foot. In its early stages, the problem may be relieved by keeping the area dry, exposing it to air as much as possible, and avoiding tight clothes. Nonprescription creams, oint- ments, liquids, powders, and sprays are available for treatment. Most cases can be self-treated, but sometimes prescribed medication is needed.
SexuallY tRanSMitted diSeaSeS
Sexually transmitted diseases (STDs), also known as sexually transmissible infections (STIs), are diseases that spread from one person to another through sexual contact. The incurable STDs, such as HIV/AIDS, hepati- tis B, genital herpes (HSV-2), and human papillomavirus (HPV) infection, are caused by viruses. Although they cannot be cured, it is possible to prevent, relieve, or reduce their symptoms. Gonorrhea, chlamydia, syphilis, trichomonas infection, lymphogranuloma venereum, chancroid, granuloma inguinale, pubic lice infesta- tions, and scabies are curable, but some have serious consequences if not diagnosed and treated in time. The U.S. Centers for Disease Control and Prevention has published excellent fact sheets about STDs. About 15 million Americans are newly infected each year. The common symptoms include abnormal discharge from the vagina or penis; pain or burning with urination; itching or irritation of the genitals; sores, blis- ters, or bumps on the genitals; rashes, including rashes on the palms of hands and soles of feet; and pelvic pain. However, other infections or conditions can cause these symptoms and some people who acquire an STD experi- ence no symptoms. For example, only 10% to 25% of HSV-2 carriers have symptoms of genital herpes and most new infections are transmitted by such people.11
Women are more likely than men to suffer long- term consequences, which include pelvic inflammatory disease, infertility, chronic pelvic pain, and cancer of
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*Numbers in the middle columns are rates of accidental pregnancy during one year of use. Typical use means used incorrectly or not used with every act of intercourse. Ideal use means consistent and correct use. †Clinics offer some of these services at lower cost. Sources: Pregnancy rates obtained from Choices.16 Costs obtained from Planned Parenthood Web site (www.plannedparenthood.org), October 2011.
Method
Surgical Male sterilization Female sterilization
Hormonal Depo-Provera
Implanon implant
Pill
Ortho Evra patch
Vaginal ring
Barrier Cervical cap Have given birth Never given birth
Diaphragm with spermicide
Condom (female) Condom (male) Vaginal sponge Have given birth Never given birth Vaginal foam, film,
cream, jelly, or suppository
Intrauterine device Mirena ParaGard
Other/None Fertility awareness Post-ovulation Symptothermal Ovulation Calendar
Coitus interruptus (withdrawal)
No method used
contRaceptive effectiveneSS and coStS* Table 19-1
Yearly Pregnancy Rate/100 Women
Typical Ideal
0.15 0.1 0.5 0.5
3 0.3
0.01 0.01 8 0.3
8 0.3
8 0.3
32 26 16 9
11.5 6
21 5 15 2 24 20 12 9 13–29 6–15 28 18
0.1 0.1 0.8 0.6
25 1 25 2 25 3 25 9
27 4
85 85
Typical Cost†
$350–$1000 $1500–$6000
Doctor’s charges plus $30-$75 per shot every 3 months
$400–$800 (lasts 3 years)
Doctor’s charges plus $20–$50/month for the pills
Doctor’s charges plus $15–$70/month for the patches
Doctor’s charges plus $15–$70/month for the rings
Doctor’s charges plus $60–$75 for cap; additional cost for spermicide
Doctor’s visit plus $15–$75 for diaphragm
$4 each 65¢–$3 each $3–$5 each plus cost
of spermicide
20¢–40¢ per use
$500–$1000 for device, exam, inser- tion, and follow-up
Charts and kits are inexpensive
No cost
No cost
the cervix. Women are also less likely to seek treatment because they have no early symptoms. In addition, they are more likely to become infected through a single encounter. The major preventive strategies include reducing the number of sexual partners, delaying the onset of sexual activity, and practicing safer sex. Using a con- dom correctly and every time greatly reduces the risk of transmission. However, breakage and/or slippage can occur, and some STDs (most notably herpes) can enter the skin outside of the area covered by the condom. The FDA12 has warned that several companies are marketing products that are fraudulently claimed to prevent STDs. Most cases of HPV can be prevented by vaccina- tion. The FDA has approved two products for use from age 9 through age 26: Gardasil and Cervarix. Gardasil is for males and females. Cervarix is just for females. The optimal age for administration is 11 or 12.13
Highly active antiretroviral treatment (HAART) has transformed HIV/AIDS into a chronic, manageable disease, but recipients may still be able to infect others. Thus proper condom use remains an important strategy against HIV transmission.
contRaception
Contraceptives are drugs or devices used to prevent pregnancy. Five major types are used today in the United States: fertility awareness (rhythm) methods, barrier methods, intrauterine devices (IUDs), hormonal methods, and surgical sterilization. Planned Parenthood Federation of America14 sug- gests these considerations when selecting a contraceptive method:
• Personal preference: Choose a method with which you are physically and emotionally comfortable and can use consistently.
• Safety: Be aware of any health risks involved, including the risk of sexually transmitted diseases. (The only products that can protect against STDs are condoms made of latex or polyurethane.)
• Effectiveness: Choose a method that provides the amount of protection you need to feel secure. For maximum effective- ness, the method must be understood and used carefully and consistently.
• Convenience: This includes availability and affordability. • Partner preference .
The most recent major survey (2006) found that 49% of pregnancies in the United States were unintended, and about half of these occurred after contraception had failed or been used improperly.15 Table 19-1 compares the failure rates and cost of the various methods. More
Chapter Nineteen Sexual and Reproductive Health 407
detailed information is available on the Web sites of Planned Parenthood (www.plannedparenthood.org) and Bridging the Gap Communications (www.managingcon- traception.com). The Planned Parenthood site also has an interactive tool to help identify suitable methods.
Fertility Awareness Methods Fertility awareness (rhythm) methods depend on abstain- ing from intercourse or using other forms of contracep- tion during the fertile days of the menstrual cycle. The fertile days are the few days leading up to and including the day of ovulation. Ovulation can be determined by noting (a) changes in body temperature taken each morn- ing, (b) changes in the character of cervical mucus, (c) the position of the cervix, or (d) a combination of these methods. These methods are economical, free of side effects, and practiced successfully by many women, but they are among the least effective even when followed perfectly. They work best in women whose menstrual cycles are regular. Several approaches exist. The symptothermal method takes temperature, mucus characteristics, and cervical position into account. Merely checking mucus (ovulation method) or counting days for several months (calendar method) is not as reliable. The post-ovulation method requires abstention or use of a barrier method from the beginning of each period until the morning of the fourth day after predicted ovulation. Test kits that attempt to predict ovulation are avail- able for home use. They can be useful for helping to achieve pregnancy, but they are not reliable for contra- ceptive purposes. Because sperm can live in the female reproductive tract for a few days, pregnancy can result from having unprotected intercourse a few days before the test shows that ovulation has occurred. Barrier Methods Barrier methods work in one of two ways: the sperm are either immobilized by a chemical (cream, jelly, foam, film, or suppository) or mechanically blocked (diaphragm, cervical cap, or condom) from entering the uterus. Contraceptive effectiveness depends on how conscientiously the method is used. Combinations of a mechanical and a chemical method are far more effec- tive than either type used alone. Barrier products include the following: Male condom: The male condom is a sheath of thin synthetic material (latex or polyurethane) or animal tissue that fits over the penis. All offer good protection against pregnancy, but only the synthetics offer good protection against STDs. Consumer Reports17 has noted that skin condoms (made from part of the intestine of a
Personal Glimpse
Sample Script for Safer Sex18
If your partner says: What’s that? You can say: A condom, baby.
If your partner says: What for? You can say: To use when we’re making love.
If your partner says: Rubbers are gross. You can say: Being pregnant when I don’t want to be
is more gross. So is getting AIDS.
If your partner says: Rubbers aren’t romantic. You can say: Making love and protecting each other’s
health sounds romantic to me.
If your partner says: Let’s face it. Making love with a rubber on is like taking a shower with a raincoat on.
You can say: Well, doing it without a rubber is like playing Russian roulette.
If your partner says: But I love you. You can say: Then you’ll help me protect myself.
If your partner says: I guess you really don’t love me. You can say: I’m not going to “prove my love” by
risking my life.
If your partner says: I’m not using a rubber no matter what.
You can say: Well then, I guess we’re not having sex.
lamb) are less likely to break than latex condoms but do not prevent transmission of the viruses that cause AIDS, genital herpes, or hepatitis. People who are sensitive to latex can use polythylene condoms. Female condom (“vaginal pouch”): The female condom is a soft, loose-fitting polyurethane sheath and two diaphragm-like, flexible polyurethane rings. One ring, which lies inside the sheath, fits internally like a diaphragm and anchors the sheath inside the vagina. The other ring forms the outer edge of the sheath and remains outside the vagina. The female condom is easy to use and does not require fitting by a health professional. It is thicker and covers more of the genital area than the male condom, which means it may offer more protection against sexually transmitted infections. Diaphragm: The diaphragm is a flexible rubber bar- rier that covers the cervix and provides protection for 6 hours. It must be fitted by a doctor, but some women’s anatomy will not permit a diaphragm to stay in place. Learning to use a diaphragm may take time and patience. It should be used with contraceptive jelly or cream and left in place for at least 6 hours after intercourse. Wearing
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a diaphragm more than 24 hours is not recommended because of the possible risk of TSS. Cervical cap: The cervical cap is a flexible cup-like device about 11/2 inches in diameter that fits snugly over the cervix. It can be inserted many hours before sexual activity and left in place for up to 48 hours. A pelvic examination by a physician is needed to determine the correct size. The cap is recommended only for women with a normal Pap smear, and another Pap smear should be obtained after 3 months of use to be sure that abnormal changes have not occurred in the cervical tissue. (They occur in about 4% of users.) It is also recommended that users apply spermicide with each use and leave the device in for 6 to 8 hours after intercourse. Petroleum jelly (Vaseline) and other oil-based sub- stances should not be used as vaginal lubricants because they can damage condoms, diaphragms, and caps and irritate the vagina. When lubrication is needed, a water- based product such as K-Y Jelly should be used. Spermicidal foam, cream, jelly, film, suppositories: These products contain nonoxynol-9, a chemical that kills sperm on contact. To be effective, the product must cover the cervix. Combining them with a con- dom, diaphragm, or cervical cap greatly enhances their contraceptive effectiveness. Used alone, aerosol foams are the most effective of these products. Contraceptive suppositories tend to lose their effectiveness within 30 minutes after insertion. Nonoxynol-9 may cause vaginal irritation that can increase the risk of HIV transmission. Vaginal contraceptive sponge: The vaginal sponge is a soft, round sponge, approximately 2 inches in di- ameter, made of polyurethane, and impregnated with nonoxynol-9 that is activated by moistening the sponge with water. When properly inserted, it covers the cervix. The sponge is considered effective for 24 hours after insertion and should be left in place for at least 6 hours after intercourse but removed within 48 hours of inser- tion. A polyester loop attached across the bottom of the sponge permits easy removal.
Intrauterine Devices (IUDs) IUDs involve the insertion by a doctor of a small piece of plastic. When the IUD is in place, an attached string hangs through the opening of the cervix so the position of the IUD can be checked. IUDs offer convenience and a high rate of effectiveness as long as they stay in place. In some women they can have major side effects, such as bleeding and increased menstrual cramping. If a sexually transmitted infection occurs after an IUD is inserted, its presence can make the infection more serious. Two types of IUDs are available in the United States.The ParaGard, which is effective for at least 12
years, has fine copper wire coiled around the plastic part and releases copper to prevent sperm from reaching the uterus and prevent implantation of a fertilized egg. The Mirena, which is approved for up to 5 years and is probably effective for 8 or more years, has an insert that releases progestin, which thickens cervical mucus to pre- vent sperm from entering the uterus and thins the uterine wall to block implantation. The Mirena also decreases menstrual cramping, greatly decreases menstrual blood flow, and has about a 20% chance of stopping menstrual bleeding after a year of use. IUDs are not recommended for women with multiple partners or those who have had a recent or recurrent pelvic infection, tubal pregnancy, very heavy periods, or previous trouble with an IUD.
Hormonal Methods In addition to the Mirena, several types of contracep- tives prevent pregnancy through the effects of female hormones. These hormones suppress ovulation, thicken the cervical mucus, interfere with the transport of sperm through the tubes, and make the tissue that lines the uterus less receptive to implantation of a pre-embryo. Oral contraceptives (OCs), available only by pre- scription, contain one or two hormones similar to those that naturally regulate menstruation. Combination pills contain estrogen and progestin (a synthetic progester- one), whereas minipills contain only progestin. OCs provide excellent reversible protection, but only if taken properly with no missed doses. Most women also experience lighter and less painful periods, a reduction in breast tenderness and lumps, and, with some OCs, reduced acne. OCs are used to treat some medical condi- tions even when contraception is not needed. Extensive studies have not established that long-term use of OCs increases the risk of developing breast cancer. Those containing both estrogen and progestin greatly decrease the risk of ovarian and uterine (endometrial) cancer. Both kinds of pills reduce the risk of developing benign breast masses and serious infections of the uterus and tubes. Cervical cancer is more common among OC users, but this appears to be due to sexual factors (mul- tiple partners) rather than the pill itself. The list of possible side effects is long, but serious problems are rare. Mild side effects, such as nausea, weight gain, fluid retention, spotting between periods, and breast tenderness, usually subside within a few months. Moderately troublesome side effects include headaches and depression. The incidence of side effects is less with the minipill, but its effectiveness is a bit lower. For this reason, use with a spermicide or condom is advantageous. Most women who take either type of pill
Chapter Nineteen Sexual and Reproductive Health 409
have no side effects or complications. Package inserts for oral contraceptive products carry an FDA-approved statement that, except for women older than 35 who smoke, the incidence of death associated with all meth- ods of birth control is low and less than that associated with pregnancy and childbirth. Estrogen-containing OCs pose a significant risk for smokers and for women with a history of blood clots in the legs or elsewhere. The smoking-related risk increases with age. Smokers and women older than 35 should not take them because they increase the risk of heart attacks and strokes. OCs are also unsuitable for women who have active liver disease, cancer of the breast or internal sexual organs, or abnormal vaginal bleeding. Depot medroxyprogesterone acetate (DMPA) is a synthetic drug that is nearly 100% effective when injected every 12 weeks. Marketed as Depo-Provera, it takes effect within 24 hours and halts ovulation for at least 14 weeks, which provides a 2-week grace period before the next injection. The most common side effects are menstrual changes: irregular bleeding and spotting, particularly in the first few months. After 1 year about half of the users do not get their periods, a situation that poses no medical risk. However, DMPA can cause loss of calcium from the bones, so use for more than 2 years is recommended only if other birth control methods are considered inadequate. The Ortho Evra patch, which releases estrogen and progestin that is absorbed into the body, is worn each week for 3 consecutive weeks, usually on the lower abdomen or buttocks. The fourth week is patch-free to permit menstrual flow. The NuvaRing is a flexible 2-inch-diameter ring that is placed in the vagina for 3 weeks and then removed for 7 days to permit bleeding. Like OCs, it delivers both estrogen and progestin and has similar effects. This method is often tolerated by women who are not pleased with or who have trouble remembering to take OCs. In the past, the higher doses of estrogen in OCs tended to cause water retention and weight gain. Current low-dose OCs and the other methods rarely have this ef- fect, but all contain progestins which, because they tend to increase metabolism, can increase appetite. Weight gain can be avoided by eating and exercising sensibly.
Emergency Contraception Emergency contraception pills (ECPs) contain the hormone progestin and are sold under the names Plan B, Plan B One-Step, and Next Choice. They work by preventing ovulation or, if that has already occurred, by blocking implantation of a fertilized egg in the uterus.
Anyone 17 or older can purchase these products from pharmacies without a prescription. Women 16 and younger must have a doctor’s prescription, which can be obtained through an office visit or by telephone. ECPs are commonly referred to as “the morning- after pill” even though they involve more than one pill and do not need to be taken on the “morning after.” They can be taken up to 120 hours after unprotected sex, but the earlier they are used, the more effective they are. If taken within 12 hours, the pregnancy rate is 0.4%. If taken within 1 to 3 days, the rate is 2.7%. About 25% of users experience nausea.16 The most effective form of emergency contracep- tion (about 1 pregnancy per 1000 users) is the Paragard IUD, which works if inserted within 5 to 8 days after unprotected sex and can remain for ongoing protection. Surgical Sterilization Close to half the married couples who intend to avoid pregnancy include one partner who has been sterilized. Sterilization has the advantage of being permanent. Reversal surgery can be attempted, but it may not work, so the decision to undergo sterilization should be made carefully and only when it is certain that no more preg- nancies are desired. Sterilization in women (tubal ligation) destroys a portion of the fallopian tubes by placing clips or bands, burning them with an electric current, and/or cutting them directly. These procedures are usually done by laparoscopy through one or two small incisions. Most are performed as outpatient operations in the hospital or a surgery center. After tubal ligation, sperm can no longer reach the eggs released by the ovaries. The eggs then die and are resorbed just as they are during any other cycle in which pregnancy does not occur. Tubal ligation also reduces the risk of ovarian cancer, probably by preventing viruses and other substances from reaching the ovaries in the same way that sperm do. Male sterilization (vasectomy) is accomplished by cutting and sealing off the tube (vas deferens) from each testicle through which sperm travel before they are stored for ejaculation. In the traditional method, a local anesthetic is injected into the area, an incision is made on each side of the scrotum, and the tubes are located and blocked. Minor complications (swelling, tender- ness, blood clots, infections, and sperm leakage under the skin) occur in a small percentage of cases. With the no-scalpel method (microvasectomy), the scrotal skin is opened by puncture to reach the vas deferens. Micro- vasectomy decreases the possibility of complications. These procedures take about 20 minutes and are done
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on an outpatient basis. A number of ejaculations must take place (typically 15 to 20) before all stored sperm are expelled. Laboratory examination of semen specimens (sperm counts) should be done several times in the 1 to 3 years after a vasectomy to verify that the tubes have not reopened.
voluntaRY aboRtionS
A 1973 Supreme Court decision prohibits the states from banning voluntary abortions during the first and second trimesters of pregnancy. In 2008 about 1.2 million vol- untary abortions were performed in the United States.19
The method used depends on the stage of pregnancy, associated medical conditions, and the skill and prefer- ence of the physician. During the first trimester (up to 13 weeks after the last menstrual period), abortion can be done with either medication or a vacuum aspiration in which the cervix is dilated (opened wider) and the uterine contents are removed by suction. During the second trimester, vacuum aspiration is most commonly used, but medical induction is also possible. Bleeding, cramping, and nausea are less common after a surgical abortion, and medical abortions often require dilatation and evacuation to complete the process. From 17 to 24 weeks a dilatation and evacuation may still be performed or a solution of saline (salt), prostaglandin, and/or urea is injected into the uterus. Prostaglandin can also be administered by vaginal suppository. These substances cause the uterus to contract and expel its contents in a process that resembles labor. The complication rate of induced abortion is less than 1% during the first trimester, but rises gradually (to 2% to 3%) the later the procedure is performed. About 95% of voluntary abortions take place during the first 13 weeks. Many of the rest are done because of severe fetal abnormalities detected with screening tests. Overall, the rates of complication and death from abortion are low20 and are much lower than the risks of carrying a pregnancy to term. Abortion is a highly controversial subject.21 “Pro- choice” advocates believe that women should have the freedom to choose whether to have a child or terminate unwanted pregnancies. “Pro-life” advocates state that abortion is morally wrong because it involves the de- struction of human life. The opposition comes primarily from Roman Catholicism, fundamentalist, and evangeli- cal factions. Much of the controversy involves debate about when personhood begins. Since the 1973 Supreme Court decision that legal- ized abortions, opponents have lobbied for passage of
state and federal laws that make it more difficult for women to obtain them. Federal funding through Med- icaid has been restricted to cases in which an abortion is deemed necessary to protect the woman’s life or when the pregnancy resulted from incest or rape. Laws requiring a waiting period, parental or spousal consent, or another procedural delay have been enacted, but some have been overturned by the courts.22 Opponents hope for passage of a constitutional amendment that would nullify the Supreme Court decision, but so far this seems unlikely. Women who need help in deciding whether to terminate a pregnancy can obtain counseling from some physicians, clergy, local family planning clinics, women’s centers, and Planned Parenthood offices. The “pro-life” viewpoint is available from some physicians and clergy, as well as from Birthright USA, Alternatives to Abortion, and similar groups that maintain offices in many American cities. Many antiabortion information centers have been listed in the Yellow Pages under abortion services, al- ternatives to abortion, birth-control information centers, or family planning information centers, despite the fact that their only service was antiabortion advice.23 Some Web sites pretend to be balanced but include misleading statements intended to discourage abortion. The Heritage House Web site (www.abortionfacts.com) is the most no- table of these. Planned Parenthood advises women who want help in deciding whether to terminate a pregnancy to select a clinic or pregnancy counseling center that (a) has clearly established a good reputation, (b) provides a full range of contraceptive alternatives, and (c) offers or is supervised by a physician, nurse practitioner, or other licensed health professional. Some opponents have campaigned to intimidate abortion providers and their patients. Their activities have included picketing, blockades, and invasions and vandalism of facilities where abortions are performed; stalking of staff members; bombings; arson; death threats; and other personal attacks. Several physicians and other staff members have been murdered and many have been attacked with acid.24 The 1994 federal Free- dom of Access to Clinic Entrances Act makes it a federal crime to use or attempt to use force, the threat of force, or physical obstruction to injure, intimidate, or interfere with providers of reproductive health-care services or their patients. It also outlaws damaging or destroying the property of a reproductive health-care facility. Enforce- ment of this law and civil lawsuits have reduced some types of harassment, but abortion providers believe their facilities are still under siege.
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infeRtilitY
Infertility is defined as failing to achieve pregnancy despite one year of regular sexual intercourse without contraception. The problem is attributable to the man in about one-third of couples and to the woman in about another third. In some couples, both are impaired; and in others, no problem can be identified. With specialized help, about half of infertile couples achieve pregnancy. Certain procedures increase the likelihood of multiple births. Evaluation of the man begins with a sperm count. Evaluation of the woman is more complex and involves checking for problems with structure and function of the ovaries, fallopian tubes, and uterus. This usually begins with blood and x-ray tests that are the simplest and least expensive. For men, the best type of physician may be a board-certified urologist who has 2 years of special training in andrology. For women, the best specialist is a board-certified obstetrician-gynecologist. Resolve, a nonprofit group that provides compre- hensive information about infertility, advises using an infertility specialist if (a) the woman is age 35 or older, (b) microsurgery is needed, (c) there have been three or more miscarriages, (d) the menstrual cycle and ovulation have not responded to clomiphene (Serophene) treat- ment, (e) the semen is seriously defective, (f) the woman has a history of pelvic infection, (g) the couple has been unable to conceive for 2 years despite “normal” basic tests, or (h) the couple is considering in vitro fertilization (IVF) or other assisted reproductive technology.25 (IVF is a technique in which egg cells are fertilized outside the woman’s body and transferred to the woman’s uterus through a thin plastic tube.) Resolve maintains a online directory of its professional members who pay an annual fee for the listing, but it cautions that the people listed are not screened to meet any Resolve criteria. The Society for Assisted Reproductive Technology (www.sart.org) publishes the IVF success rates of clinics in the United States. Some infertility procedures are very expensive and often are not covered by insurance policies. When relevant, it is prudent to get written confirmation of insurance coverage.
genetic teSting and pRenatal counSeling
Normal human cells contain 23 pairs of chromosomes. Each pair has one contributed by the mother and one contributed by the father. Each chromosome is a tightly coiled strand of DNA (deoxyribonucleic acid). A gene is a tiny segment of DNA that directs the formation of
an enzyme or other protein. About 4000 diseases are known to be caused by defective chromosomes or genes. About 500 laboratories, most affiliated with hospitals, provide genetic testing services. Research in this field is progressing very rapidly. Genetic counseling can help prospective parents review the facts in light of their personal beliefs. It is commonly recommended for all women older than 35 and for others at risk for bearing a child with a genetic defect that is detectable by commercially available test- ing. These include hemophilia, sickle cell disease, thalassemia (a severe type of anemia), cystic fibrosis, Down syndrome, Canavan’s disease (a degenerative brain disease), and Tay-Sachs disease (a degenerative disease that results in considerable suffering and death by the age of 4). Genetic counseling has become a routine part of prenatal care for many women at increased risk of car- rying an abnormal fetus.26 Some abnormalities are life- threatening or will result in disabilities so severe that the offspring will suffer greatly or be incapable of becoming self-sufficient. Other abnormalities will result in only minor dysfunction. Detection of certain conditions may lead to a decision to terminate the pregnancy or can facilitate planning for the special needs of a physically or mentally handicapped child. The counseling process usually starts with the woman’s primary care physician or obstetrician but may require the services of a specialist. The American Board of Medical Genetics offers certification in clini- cal genetics and related fields to physicians and others with doctoral degrees. The American Board of Genetic Counseling offers certification in genetic counseling, for which at least a master’s degree is required. Pregnant women who are at risk for giving birth to a child with genetic abnormalities may be candidates for screening procedures in which fetal chromosomes are examined. In chorionic villus sampling, which can be done between the 10th and 12th week of pregnancy, a long needle is inserted through the abdomen or vagina to remove a tiny specimen of placental tissue for exami- nation. In amniocentesis, which is performed between weeks 16 and 20, about 1 ounce of the fluid surrounding the fetus is removed from the uterus. The findings may lead to a decision to terminate the pregnancy.
pRegnancY and deliveRY
This section covers some of the decisions that must be made about self-care, professional services, and birth- ing options.
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Initial Evaluation Blood pressure Hemoglobin/hematocrit Hepatitis B surface antigen RPR/VDRL (for syphilis) Chlamydia and gonorrhea screen Rubella antibody test Rh incompatibility testing Assess for problem or risk drinking HIV screening Discuss genetic counseling and testing
Subsequent Screening Blood pressure (each visit) Urinalysis (each visit) Diabetes screen (blood sugar test
following glucose administration) Urine culture (12 to 16 weeks) Multiple marker testing: serum
alpha-fetoprotein, HCG, and estriol (15 to 18 weeks)
Amniocentesis and/or other genetic tests as desired (15 to 18 weeks)
Culture for group B Streptococcus
inteRventionS RecoMMended foR pRegnant WoMen
Table 19-2
Counseling Multivitamin with folic acid Tobacco cessation; effects of
passive smoking Alcohol and other drug use Nutrition, including adequate
calcium intake Encourage breastfeeding Lap/shoulder belts Regular physical activity Infant car seats STD prevention
Source: U.S. Preventive Services Task Force Web site (www.uspreventiveservicestaskforce.org), plus help from Timothy N. Gorski, M.D., F.A.C.O.G.
Pregnancy Testing When a woman is pregnant, human chorionic gonadotro- pin (HCG) appears in her blood and subsequently in her urine. This hormone, which is produced by the chorion (the membrane surrounding the embryo in the uterus), is the substance measured in pregnancy tests. The most accurate tests (radioreceptor assay or radioimmunoassay) are performed by laboratories on blood samples. Do-it-yourself urine test kits are available. If done carefully, the tests are usually accurate when positive, but they may be a needless purchase. If the result is positive, indicating that pregnancy is probable, a visit to a physician is advisable. If the physician believes it is important to confirm the diagnosis, the woman will wind up paying for two pregnancy tests.
Prenatal Care The vast majority of women receive their prenatal care from a physician. Prenatal care is best begun when preg- nancy is suspected and will involve evaluation of the woman’s medical history, a physical examination, and discussion of any special concerns. Current medications should be discussed to determine whether they pose any risk to the developing baby. Diet should be discussed to be certain that the mother-to-be has an adequate nutri- ent intake, particularly of calcium, iron, and folic acid. (Chapter 10 discusses the importance of adequate folic acid intake to prevent certain birth defects.) Although an appropriate diet will supply what most women need, a prenatal supplement is usually recommended. Appropriate nonprescription products are available in drugstores for less than 10¢ per day. There is usually no reason to purchase prescription prenatal formulas that cost several times as much.
Most obstetricians recommend that prenatal visits take place monthly until the seventh month of pregnancy and then increasing the frequency of visits as the due date approaches. It is advisable to clarify when payment is expected and, if the patient has insurance, whether the doctor is willing to wait for payment of the portion due from the insurance company. Table 19-2 summarizes the screening tests and other medical interventions that the U.S. Preventive Services Task Force recommends for pregnant women. The U.S. Centers for Disease Control and Prevention (CDC) recommends testing all pregnant women during the seventh or eighth month of pregnancy to see whether they are carrying group B Streptococcus (GBS).27 GBS is the most common cause of life-threatening infections in newborns. Detecting it and treating the mother dur- ing labor reduces the risk of newborn infection from about 1% to about one-tenth of 1%. The test specimen is obtained by placing a cotton-tipped swab in the vagina and rectum. Women who test positive for GBS pose no danger to other children. The CDC recommends that pregnant women avoid certain soft cheese products and deli meats and cook seafood, meats, and poultry thoroughly to reduce the risk of listeriosis, an infection that can cause miscarriage and stillbirth. The FDA recommends that pregnant women avoid eating shark, king mackerel, swordfish, and tile- fish because they tend to have the highest amounts of mercury. The March of Dimes28 recommends that all women have multiple marker testing to screen for neural tube defects, Down syndrome, and trisomy 18 (a condition with serious birth defects that usually results in death within 1 year). If the test is abnormal, further testing
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will be offered to clarify the situation. The most com- mon such test, often referred to as an “AFP Tetra” or “Quad Screen,” is performed between weeks 15 and 19 of pregnancy. Ultrasound screening is popular but has not been demonstrated to improve outcome without a definite medical reason to use it.30 The FDA has cautioned against obtaining “keepsake” prenatal ultrasound pictures (see Consumer Tip box). Although ultrasound examination during pregnancy is thought to be very safe, it is known to exert subtle effects on living tissue and should not be used for entertainment purposes. Most insurance com- panies do not pay for ultrasound testing without a valid medical indication. Gestational diabetes is a temporary form of insu- lin resistance that usually reveals itself about halfway
through pregnancy and resolves after delivery. If post- partum tests remain higher than normal, it is important to increase exercise and maintain a normal body weight to try to prevent diabetes from developing.31 Chapter 14 discusses the diagnosis and treatment of diabetes. When choosing a doctor, inquiries also should be made about the doctor’s practice style, availability, fees, hospital policies regarding labor and delivery, pain-relief options, and the likelihood that the doctor will be the person who actually does the delivery.32 The best choice is likely to be an obstetrician/gynecologist who (a) trained at a university-affiliated program, (b) is board-certified, (c) is a Fellow of the American College of Obstetricians and Gynecologists (F.A.C.O.G.), (d) is easy to talk to, and (e) answers questions adequately. Women who are selecting an obstetrician should ask about the doctor’s attitude toward cesarean deliveries. The best way to avoid an unnecessary cesarean is to be under the care of a physician whose attitudes about delivery are in agreement with your own and who will discuss the relevant issues with you in an understandable way on a continuing basis. Childbirth education classes can help prepare future parents for labor and delivery. They typically teach how breathing and relaxation exercises can lessen the fear of labor and may reduce the amount of anesthesia required. Women who are pregnant for the first time and their partners are likely to benefit considerably from knowing what to expect. Birthing Options An out-of-hospital childbirth movement began in the mid-1970s in response to feelings that hospital care was too cold and impersonal and did not pay sufficient attention to emotional needs. Since then, most hospital programs have integrated the concept of family-centered childbirth. The improvements include permitting the woman’s partner to stay with her during labor and de- livery and permitting mother and child to share a room after delivery. However, some women prefer to have their delivery take place outside of a hospital setting and prefer to be attended by a midwife rather than a physician. Freestanding childbirth centers offer one such op- tion. They are less expensive than hospitals but can pose additional risk for the 10% to 15% of women in labor who develop a problem that needs urgent medical atten- tion. Women considering this option should carefully inquire about the qualifications of the person perform- ing the delivery and the availability of emergency care. Some midwives are advanced nursing professionals who are formally trained and licensed, whereas others are
“Keepsake Ultrasound” The FDA has expressed concern that “facilities with captivating names such as Fetal Fotos, Peek-a-Boo, Womb with a View, and Baby Insight are popping up in strip malls and shopping centers” to offer “keepsake videos” that use the ultrasound technology to produce high-resolution three-dimensional and moving images showing the surface anatomy of babies developing in the womb. As noted in FDA Consumer29:
• Obstetricians use ultrasound at a very low power level to check the size, location, number, and age of fetuses and the presence of some types of birth defects, fetal movement, breathing, and heartbeat. When ultrasound is used by a qualified clinician to check for this kind of medical information, the medical benefit far outweighs any risk.
• Even though ultrasound has been around for many years, the long-term effects of repeated ultrasound exposures on the fetus are not fully known. In light of all that remains unknown, having a prenatal ul- trasound for nonmedical reasons is not a good idea.
• It is illegal to take fetal ultrasound pictures unless there is a valid medical reason to do so. The valid reasons include diagnosing pregnancy, determin- ing fetal age, diagnosing congenital abnormalities, evaluating position of placenta, and determining multiple pregnancies.
• Some video companies have used high-energy ex- posures for as long as an hour to get the pictures. Exposure to ultrasound for longer than the time specified by the FDA for fetal monitoring could pose a potential risk to the health of the mother and her developing fetus.
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not. Some expectant mothers employ a doula, a woman who offers emotional and physical support and practical information before, during, and/or after the period of childbirth.33 Home delivery is another option. It is suitable only for normal (low risk) deliveries and runs an additional risk of infection. Timothy N. Gorski, M.D., F.A.C.O.G., of Arlington, Texas, likens home birth to skiing under conditions where medical help is not readily available. He warns that, “In most instances everything works out fine, but the consequences can be catastrophic when an unexpected complication arises.” A few studies have compared the outcome of planned home births and planned hospital births among women whose deliveries were considered low risk and who were attended by well- trained midwives. A meta-analysis33 found that home birth led to fewer complications among the mothers but the babies had higher death rates. Cesarean Delivery From 1998 through 2007, the percentage of cesarian births rose steadily from 21% to 32%.35 In addition to clinical reasons, nonmedical factors suggested for the increase include maternal demographic characteristics (e.g., older maternal age), physician practice patterns, maternal choice, more conservative practice guidelines, and legal pressures. Many people believe that the main factor is doctors’ fear of being sued if there is a complica- tion from a vaginal birth. Some also claim that doctors do cesareans for their own convenience or to get larger fees; however, insurance companies pay little or nothing extra for cesarean deliveries. Vaginal birth after a cesarean (VBAC) was once viewed as a way to reduce the overall cesarean delivery rate. Unfortunately, depending on the hospital and other factors, emergency cesarean delivery in the event of complications may not be available quickly enough to prevent injury or death to the baby. VBAC has become even more controversial since recent evidence has shown the risk of uterine rupture ranges from 5 to 7 per 1000 attempts to 24 per 1000 when certain medications are used to induce labor. In addition, other studies have documented that injuries to the tissues of a woman’s pelvic floor at the time of vaginal birth are more com- mon than previously thought. (The pelvic floor is the muscular band that supports the woman’s uterus, blad- der, rectum and vagina.) This has caused some women to request cesarean delivery. Again, these issues should be discussed thoroughly with one’s physician. The Newborns’ and Mothers’ Health Protection Act of 199636 prohibits many insurance plans from restricting benefits for a hospital stay for childbirth to less than 48
hours after a vaginal delivery or 96 hours after a cesarean delivery.
coRd blood banKing
A few companies provide processing and storage of stem cells from umbilical cord blood for potential future use by the child or family members. The cost is about $1500 plus about $100 per year for storage.37 Stem cells are being studied with the hope that they can be used to restore diseased organs. Private cord blood banks suggest that saving a baby’s cord blood may one day help the baby or family members if restorative treatment is per- fected. However, the American Academy of Pediatrics (AAP)38states there is no strong evidence to recommend routine cord blood banking for an infant’s future use. Its 2007 position statement on that subject estimates that unless a family member has leukemia or another disease for which stem cells might be useful, the likelihood of needing the cells is extremely small. (Estimates range from 1 in 1000 to more than 1 in 200,000.) Others have noted that people who receive their own stem cells might be prone to repeat the same disease. Donating to a public cord blood bank is a better idea.39
infant feeding
Although formula feeding can adequately meet the physical and emotional needs of the newborn infant, many studies have shown that, except when the mother might transmit a dangerous organism (such as HIV) or a potentially toxic drug, breastfeeding is advantageous.40 Human milk and breastfeeding of infants are better for general health, growth, and development and signifi- cantly decrease the risk for many diseases. A recent study even suggests that breastfeeding may increase the IQ scores of children who were small for their gestational age at birth.41
Mothers also benefit. Lactating women have an earlier return to prepregnant weight, reduction in hip fractures in the postmenopausal period, and reduced risk of ovarian cancer and premenopausal breast cancer.
The success of breastfeeding is facilitated by guid- ance from a knowledgeable relative or health profession- al. The American Academy of Pediatrics40 recommends:
• Exclusive breastfeeding for approximately the first 6 months and support for breastfeeding for the first year and beyond as long as mutually desired by mother and child.
• Mother and infant should sleep near each other to facilitate breastfeeding.
• Self-examination of mother’s breasts for lumps is recom- mended throughout lactation, not just after weaning.
Chapter Nineteen Sexual and Reproductive Health 415
• A pediatrician or other knowledgeable health-care profes- sional should evaluate the infant at 3 to 5 days of age and again at 2 to 3 weeks of age to be sure the infant is feeding and growing well.
Chapter 10 contains more about infant nutrition.
tReatMent of MenopauSal SYMptoMS
Menopause is the point at which menstruation and fer- tility stop due to declining production of estrogen and progesterone by the ovaries. It is diagnosed after 12 months without a menstrual period. Surgical removal
of the ovaries is referred to as “surgical menopause.” Hormonal therapy is the most effective way to relieve menopausal symptoms such as “hot flashes,” night sweats, and vaginal dryness. It also reduces the lifetime risk that a woman will develop osteoporosis, vertebral fractures, and hip fractures. Earlier enthusiasm that hormone replacement therapy (HRT) at any age would reduce the risk of heart attack and stroke was dashed by a major study which found that taking estrogen plus progestin for more than 5 years places postmenopausal women at risk for heart attacks, strokes, and several other serious problems.46
In osteoporosis, the protein and mineral content of bones decreases, weakening bones so they are more easily fractured. Bone density decreases with age, especially in women when their production of estrogen declines after menopause, but men can develop osteoporosis, too. The risk is increased in people taking corticosteroids and in certain diseases like rheumatoid arthritis. Other risk factors are European or Asian ancestry, smoking, excess alcohol, a family history of frac- tures, vitamin D deficiency, too much or too little exercise, malnutrition, and low body weight. The odds of developing osteoporosis can be greatly reduced by adopting preventive lifestyle measures early in life. Osteoporosis itself has no symptoms. Often the first sign is a fracture of the hip or wrist after a minor fall. Some women lose height or develop a hunched back caused by collapse of spinal vertebrae. About half of the untreated people with osteoporosis who reach age 75 suffer at least one fracture due to the disease. Hip fractures in the elderly can be devastating, with serious complications, permanent loss of mobility, and even death. Vertebral fractures are also common, but many produce no symptoms and do not affect quality of life. Adequate calcium intake and weight-bearing exercise throughout life help to slow down the rate of bone density loss. The current Dietary Reference Intake values for cal- cium are 1300 mg/day for ages 9–18, 1000 mg per day for ages 19–50, and 1200 mg/day for ages 51 and older.42 Many people don’t get enough calcium from their diet and require supplements. Vitamin D is also important to ensure calcium absorption. In 2004 Consumer Reports43 tested 30 brands of cal- cium supplements, 18 of which also contained vitamin D. All contained the amount of calcium stated on their label, four contained enough lead to exceed a California standard, and three did not dissolve as fast as they should. Nearly all came reasonably close to the labeled amount of vitamin D. The editors recommended choosing one of the less expensive brands that had passed its tests. The absorbability of calcium pills can be tested at home
by placing a tablet in vinegar. One that does not disintegrate within 30 minutes is unlikely to be well absorbed. This problem can be overcome by chewing the tablet, letting it dissolve in the mouth before swallowing it, or switching to a better brand. The most accurate test for bone mass density is dual- energy x-ray absorptiometry, which is commonly referred to as a DXA or DEXA scan. The results are compared to two standards (norms). The Z-score is a comparison to others of the same age and gender. The T-score is a comparison with optimal bone density and is the best estimate of fracture risk. Moderately low scores may be designated “osteopenia,” but this is more of a risk factor for osteoporosis than a disease in its own right. Some companies offer direct-to-consumer ultrasound screening for osteoporosis, but when results are abnormal, a DXA scan is required for confirmation. The U.S. Preventive Services Task Force44 currently rec- ommends that women 65 and older be screened routinely for osteoporosis. It recommends that routine screening begin at age 60 for women at increased risk for osteoporotic fractures. A handy online FRAX tool for estimating an individual’s risk is posted at www.shef.ac.uk/FRAX. Lost bone tissue is not easily replaced, but further bone loss can be minimized with treatment. Estrogen-replacement therapy can greatly reduce the incidence of osteoporosis in women, but its use must be balanced against other consid- erations (see Treatment of Menopausal Symptoms section). Osteoporosis treatment should always include weight-bearing exercise,45 fall-prevention strategies, not smoking cigarettes or abusing alcohol, and adequate intake of calcium and vitamin D. Bisphosphonates and other prescription drugs have been proven to help prevent fractures, but they carry some risks and their effectiveness is limited. Among women ages 65-69, about 30 must be treated to prevent one vertebral fracture and 67 must be treated to prevent one hip fracture.44 The decision to treat with medication should be individualized, with careful consideration of risks and benefits.
Osteoporosis (Fragile Bones): Not Just a Women’s Health Issue
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This study had limitations, because it mainly considered older women who had already completed menopause. In addition, many who were not supposed to take hormones did, and vice versa. HRT is now mainly prescribed for the short-term treatment of postmenopausal symptoms using low doses of estrogen.47 In 2010, the Endocrine Society48 concluded that HRT can benefit some women but should be prescribed at the lowest effective dose and the shortest duration possible. Concern about adverse long-term effects of HRT has increased interest in “natural” products. However, the source of a hormone, whether from animals or plants, whether extracted from natural sources or synthesized in the laboratory, is irrelevant to safety concerns. Some preparations of black cohosh may be effective for reliev- ing hot flashes in early menopause, but studies have had conflicting results.49 Phytoestrogen extracts, probiotics, evening primrose oil, chasteberry. dong quai, ginseng, and vitamin E appear to have little or no effect on hot flashes or other postmenopausal symptoms.50,51 HRT for men has little or no scientific support. After evaluating the pros and cons of conducting a large-scale clinical study of testosterone therapy to treat age-related conditions in men 65 and older, an expert committee of the Institute of Medicine52 has recommended going forward, but only with a limited group of participants and in a stepwise fashion. Testosterone products are FDA-approved for treat- ing a few conditions, but the promotion of testosterone therapy to men seeking to counter the effects of aging has “outpaced the scientific evidence about the therapy’s benefits and risks for users, particularly the possibility that testosterone administration might increase the risk of prostate cancer.” Another potentially dangerous practice is the use of testosterone precursors or testosterone-like agents such as DHEA sold as “nutritional supplements.”
alleged Sex enHanceRS
An aphrodisiac is a food, drink, drug, scent, or device that is claimed to arouse or increase sexual desire. In 1990 the FDA banned the sale of alleged aphrodisiacs as drug products, but many are marketed as “dietary supplements.” The common ingredients include arginine, ginkgo biloba, horny goat weed, maca, tribulus terrestris, and yohimbe, none of which has been proven effective.53 Some herbal products can cause high blood pressure and sleeplessness. Spanish fly can irritate the urinary tract. The FDA advises people with sexual problems to seek professional medical help. Many products are promoted with misleading claims that they can improve erectile function and increase penis
size. The most notorious in recent years was probably EnZyte, an herbal mixture marketed by Berkeley Premi- um Pharmaceuticals. EnZyte was claimed to permanently increase the size of a man’s erection. Its sales totaled hundreds of millions of dollars. EnZyte was widely pro- moted through television commercials in which “Smil- ing Bob” touted it for “natural male enhancement.” The commercials were rife with innuendo and implied that users would become the envy of the neighborhood. The company’s promotions also included faked stories about how doctors had developed Enzyte and made-up statis- tics about customer satisfaction rates. The Cincinnati Better Business Bureau and the Ohio Attorney General received thousands of complaints about the company’s billing practices, which included offering a free trial but continuing to send the product without authorization. In 2008, company founder Steve Warshak was convicted of various fraud charges and ordered to forfeit $500 million in assets.54 Following an appeal, he was sentenced to 10 years in prison. Berkeley went bankrupt, but its assets were purchased by another company that has continued to promote EnZyte with “Smiling Bob” videos and the claim that EnZyte “has endowed millions of men with firmer, stronger, fuller-feeling erections.” “Poppers” sold under the trade names of Rush, Thrush, Hardware, Locker Room, and Bolt are used as inhalant drugs to enhance sexual pleasure but are sold as room odorizers or liquid incense; thus they have avoided FDA jurisdiction. The products are readily available in bars, discos, and some bookstores. They contain amyl or butyl nitrite, which causes dilation of blood vessels in the hands, feet, and face. Some people find the increased blood flow pleasurable. Little is known about their long-term effects, but they can cause bronchitis, burns around the nose, allergic reactions, and potentially life- threatening methemoglobinemia (a condition in which the release of oxygen from the blood to the body tissues is impaired).55 Deaths from low blood pressure have been reported among people who combined poppers and Viagra. Many people believe that alcohol enhances sexual function, but it does not. Harvey and Beckman56 reported that a study of sexually active women between the ages of 18 and 34 failed to show any objective effects of alcohol on sexual arousal, pleasure, or orgasm. Large amounts of alcohol can cause temporary impotence.
genuine Help foR eRectile dYSfunction
Erectile dysfunction (often referred to as impotence) has both physical and psychologic causes. The most com- mon physical cause is decreased circulation of blood
Chapter Nineteen Sexual and Reproductive Health 417
to the penis. Other causes are hormonal disorders, side effects of prescribed drugs, neurologic disorders, and alcohol intoxication. Contributory psychologic factors include depression, anxiety, and friction or inadequate communication between prospective partners. The first step in dealing with erectile dysfunction should be to pinpoint the cause. Unless the problem is obviously psychologic, a medical evaluation is advis- able. A primary-care physician can do an initial screen- ing and if the problem is physical, refer to a specialist (such as a urologist) if further evaluation or specialized treatment is needed. Prescription drugs (Viagra, Cialis, Levitra) have been proven effective in 50% to 80% of patients with erectile dysfunction of various types. In cases where there is a clear medical cause and the prob- lem is unlikely to resolve with other methods, a penile prosthesis (implant) may be useful.57
If the problem is psychologic, help is available from various types of mental health professionals (see Chapter 6). In some cases, simple education in technique will be enough to solve the problem. In others, improve- ment in communications skills or resolution of deeper psychologic problems will be needed. The same would also be true for women who lack interest in sex or find it unsatisfying.
Viagra has been studied for use in women. It does not seem to offer clear benefits, and its manufacturer is reported to have given up further testing in women.
SuMMaRY
Many people are faced with health problems related to the anatomy and physiology of their reproductive organs. Menstrual cramps that begin during the first year after the onset of menstruation are usually mild and self-treatable. Premenstrual syndrome will usually respond to self-help measures. Persistent menstrual irregularity is a reason to consult a physician. Many choices are available to sexually active indi- viduals who wish to prevent pregnancy. Contraceptive methods should be judged by considering effectiveness, safety, convenience, reversibility, personal acceptability, and STD prevention. Genetic testing, counseling, or other procedures may be advisable when there is a sig- nificant risk of producing an abnormal fetus. Childbirth education and appropriate provider choice can reduce the stress and risks of delivery. Everyone should attempt to prevent osteoporosis by avoiding or correcting the lifestyle factors that tend to increase the risk of it developing. Decisions about postmenopausal therapy should be made with help from a knowledgeable physician. Erectile dysfunction is usu- ally medically treatable, but fake sex-aid pills are widely marketed.
RefeRenceS
1. Litt IF. Placing emergency contraception in the hands of women. JAMA 293:98–99, 2005.
2. Nordenberg T. Looking for a libido lift? The facts about aph- rodisiacs. FDA Consumer 30(1):10–15, 1996.
3. Calcium: How to get enough. Consumer Reports 60:510–513, 1995.
4. Tampon safety: TSS now rare, but women still should take care. FDA Consumer 34(2):20–24, 2000.
5. Tampons and pads: Should you use what Mom used? Consumer Reports 60:51–55, 1995.
6. Menstrual cups. Wikipedia Web site, accessed Oct 10, 2011. 7. Brown J and others. Selective serotonin reuptake inhibitors
for premenstrual syndrome. Cochrane Database of Systematic Reviews April 15;(2):CD001396, 2009.
8. What treatments work for heavy periods? Consumer Reports Medical Guide Web site, Dec 22, 2004.
9. Trichomoniasis: CDC fact sheet. CDC Web site, Dec 19, 2007. 10. Senok AC and others. Probiotics for the treatment of bacterial
vaginosis. Cochrane Database of Systematic Reviews, Issue 4, Article No. CD006289, 2009.
11. Tronstein E and others. Genital shedding of herpes simplex virus among symptomatic and asymptomatic persons with HSV-2 infection. JAMA 305:1441–1449, 2011.
It’s Your Decision
If you have a need for contraception, which of the fol- lowing methods would you be most likely to consider? Select up to five and list the advantages and disadvantages of each:
Abstinence; cervical cap; coitus interruptus; condom (female); condom (male); Depo-Provera; diaphragm; fertility awareness; IUD; oral contraceptive pills; Ortho Evra patch; sterilization (female); sterilization (male); vaginal foam, film, cream, jelly, or supposi- tory; vaginal ring; vaginal sponge.
You think you may be pregnant and you want to obtain confirmation of your condition. Which of the following action(s) would you take?
• Ask a friend or parent what to do • Purchase a self-diagnostic pregnancy test kit • Consult a pharmacist • Read a self-help book • Use the Internet (what type of sites?) • Immediately consult a physician • Contact Planned Parenthood • Other (specify): ________________________
Birth Control and Pregnancy
Part Five Other Products and Services418
12. FDA, FTC act to remove fraudulent STD products from the market. FDA news release, May 3, 2011.
13. HPV vaccine—questions & answers. FDA Web site, Sept 15, 2011.
14. Over the counter birth control for women. New York, 1988, Planned Parenthood Federation of America.
15. Finer LB, Zolna MR. Disparities in rates of unintended preg- nancy in the United States: Incidence and disparities, 2006. Contraception, 2011.
16. Hatcher RA and others. Choices. Tiger, Ga., 2010, Bridging The Gap Foundation.
17. Condoms get better: Tests of 30 models show far fewer failures than in past years. Consumer Reports 64:46–49, 1999.
18. Excerpted from The condom. Planned Parenthood Federation of America Web site, April 2004.
19. Jones RK, Koostra K. Abortion incidence and access to services in the United States, 2008. Perspectives on Sexual and Repro- ductive Health 43:41–50, 2011.
20. Facts on induced abortion in the United States. Guttmacher Institute, Aug 2011.
21. Baird RM, Rosenbaum SE. The Ethics of Abortion: Pro-Life vs. Pro-Choice, revised edition. Amherst, N.Y., 1993, Prometheus Books.
22. Fact sheet: Laws requiring parental consent or notification for minors’ abortions. Planned Parenthood Federation of America Web site, Aug 2002.
23. Anti-abortion counseling centers: A consumer’s alert to decep- tion, harassment & medical malpractice. Planned Parenthood Federation of America Web site, Jan 2004.
24. NAF violence and disruption statistics. National Abortion Federation Web site, accessed Oct 10, 2011.
25. Clapp DN. Selecting an infertility physician. Resolve Web site, accessed June 2000.
26. Carlson KJ and others. The New Harvard Guide to Women’s Health. Cambridge, Mass., 2004, Harvard University Press.
27. Prevention of perinatal group B streptococcal disease: A public health perspective. Morbidity and Mortality Weekly Report 45(RR-7):1–24, 1996.
28. Maternal blood screening for Down syndrome and neural tube defects. March of Dimes Web site, June 2004.
29. Rados C. FDA cautions against keepsake ultrasound. FDA Consumer 38(1):12–16, 2004.
30. LeFevre ML and others. A randomized trial of prenatal ultra- sonographic screening: Impact on maternal management and outcome. American Journal of Obstetrics and Gynecology 169:483–489, 1993.
31. Keley DB, editor. American Diabetes Association Complete Guide to Diabetes. Alexandria, Va., 1996, the Association.
32. Your Pregnancy & Birth: Information You Can Trust from the Leading Experts in Women’s Health Care. Washington, D.C., 2005, American College of Obstetricians and Gynecologists.
33. What is a doula? DONA International home page, accessed Oct 17, 2011.
34. Frequently asked questions about newborns’ and mothers’ health protection. U.S. Department of Labor, Employee Benefits Security Administration Web site, accessed Oct 10, 2011.
35. Menaker F. Recent trends in cesarean delivery in the United States. National Center for Health Statistics Data Brief No. 35, March 2010.
36. Wax JR and others. Maternal and newborn outcomes in planned home birth vs planned hospital births: A metaanalysis. American Journal of Obstetrics and Gynecology 203:243e1–243e8, 2010.
37. Barrett S. The shady side of embryonic stem cell therapy. Quackwatch Web site, Sept 9, 2010.
38. Policy Statement: Cord blood banking for potential future transplantation. Pediatrics 119:165-170, 2007.
39. Private cord blood banks. The Medical Letter on Drugs and Therapeutics 46:21–22, 2004.
40. American Academy of Pediatrics Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics 115:496– 506, 2005.
41. Slykerman RF and others. Breastfeeding and intelligence of preschool children. Acta Paediatrica 94:832–837, 2005.
42. Ross AC and others. Dietary Reference Intakes for Calcium and Vitamin D. Washington, D.C., 2010, National Academies Press.
43. Calcium: More than just a bone builder. Consumer Reports 70(1):22–25, 2005.
44. Nelson HD and others. Screening for postmenopausal osteopo- rosis: Systematic review to update the U.S. Preventive Services Task Force Recommendation. Rockville, Md., 2010, Agency for Healthcare Research and Quality.
45. American College of Sports Medicine position stand on physi- cal activity and bone health. Medicine & Science in Sports and Exercise 36:1985–1996, 2004. [Full text can be accessed by following the links to ACSM position stands.]
46. Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy post- menopausal women: Principal results from the Women’s Health Initiative randomized controlled trial. JAMA 288:321–333, 2002.
47. Nelson HD. Commonly used types of postmenopausal estrogen for treatment of hot flashes. JAMA 291:1610–1620, 2004.
48. Santen RJ and others. Postmenopausal hormone therapy: An Endocrine Society scientific statement. Journal of Clinical Endocrinology and Metabolism 95(Supp1):51–66, 2010.
49. Black cohosh. Natural Medicines Comprehensive Database, Oct 5, 2011.
50. Lethaby AE and others. Phytoestrogens for vasomotor meno- pausal symptoms. Cochrane Database of Systematic Reviews 17;(4):CD001395, 2007.
51. Borelli F, Ernst E. Alternative and complementary therapies for the menopause. Maturitas 66:333–343, 2010.
52. Liverman CT and others. Testosterone and Aging: Clinical Re- search Directions. Washington, D.C., 2003, National Academies Press.
53. Shardt D. Sex in a bottle: The hard sell. Nutrition Action Health- letter, Oct 2004.
54. Boggs DJ. Opinion. USA vs Steven Warshak et al. U.S. Court of Appeals for the Sixth Circuit. Case Nos. 08- 3997/4085/4087/4212/4429; 09-3176, decided and filed, Dec 14, 2010.
55. Romanelli F and others. Poppers: Epidemiology and clini- cal management of inhaled nitrite abuse. Pharmacotherapy 24:69–78, 2004.
56. Harvey SM, Beckman ZD. Alcohol consumption, female sexual behavior, and contraceptive use. Journal of Studies of Alcohol 47:327–332, 1986.
57. Erectile dysfunction: Penile prosthesis. WebMD Web site, Feb 23, 2011.
HealtH Devices
question: What [device] can reduce bothersome background noise, magnify nearby conversation, allow you to focus on sounds you want to hear, overcome nerve deafness, and improve speech clar- ity? answer: Nothing. aarP senior Consumer alert1
© don de lorimier
“It’s not like the old days.”
Chapter Twenty
Part Five Other Products and Services420
• Medical device regulation needs considerable reform.
• The most important step toward purchasing eyeglasses or contact lenses is a thorough professional examination.
• Although hearing aids can make sounds louder, they may not improve intelligibility in noisy areas because background noise can be amplified along with speech sounds. Before buying a hearing aid, medical evaluation is advisable.
• Quack devices are a significant problem.
Keep tHese points in MinD as You stuDY tHis cHapter
Key Concepts
Medical devices include several thousand types of health products, from simple articles such as thermometers, heating pads, contact lenses,
and hearing aids to complex medical equipment such as heart pacemakers, kidney dialysis machines, and lasers used for surgery. Federal laws define “medical device” as any health-care product that does not achieve any of its principal intended purposes by chemical action in or on the body or by being metabolized.2 (Products that work by chemical or metabolic action are defined and regulated as drugs.) The term “devices” also includes laboratory equipment; diagnostic test kits; and compo- nents, parts, and accessories of medical devices. Total sales of medical devices and diagnostic products by publicly traded corporations in the United States exceed $200 billion a year.3 In most cases where consumers encounter a device used by or prescribed by a physician, they have little need or opportunity to make a choice. It would be pointless, for example, for a patient whose blood pressure is being checked to attempt to determine whether the instrument is designed well and calibrated properly. Nor would it be appropriate or even possible for someone undergoing general anesthesia to evaluate the quality or reliability of the equipment that is used. The only practical way for consumers to protect themselves is to choose competent practitioners who presumably select and maintain their equipment properly. This chapter emphasizes devices (and related servic- es) about which consumers frequently make decisions: eyeglasses; contact lenses; sunglasses; hearing aids; water purifiers; humidifiers and vaporizers; and personal emergency response systems. It also calls attention to the little-publicized problems of spinal decompression machines, latex allergy, and quack devices.
MeDical-Device regulation
The Food and Drug Administration (FDA) is responsible for device regulation. It has the extremely difficult task
of trying to keep unsafe or ineffective products off the market while ensuring timely access to new ones. The current classification system has three classes based on (a) the extent to which use of the device involves mat- ters of life or death or serious injury and (b) whether the device is entirely new or is similar to a previously approved device. The Historical Perspectives box traces the history of device regulation. Most Class I products are subject only to the general controls that apply to all devices. These include regis- tration of manufacturers, recordkeeping requirements, labeling requirements, and good manufacturing practice regulations. Most of the devices in this category are simple products such as bandages, tongue depressors, bedpans, dentures, orthopedic shoes, and other items in which failure is unlikely to cause serious harm. Most Class I products do not require permission from the FDA before they can be legally marketed. Class II products must meet performance standards established by the FDA. However, only a few such stan- dards have been written. To market a new Class II device, the manufacturer usually must get permission through a process called “premarket notification,” commonly referred to as a “510(k),” which is the section number of the relevant regulation. This regulatory pathway can be used for devices “substantially equivalent” to others already approved. The amount of substantiation is much less than would be required for a device that is entirely new. More than 98% of the devices marketed today have gone this route. The permission granted under 510(k) is properly described as “clearance.” It is illegal to represent 510(k) clearance as “FDA approval” or to market devices for uses that have not been cleared, but manufacturers sometimes do so. Class III products are usually devices that are en- tirely new and involve life support and other critical functions. Cardiac pacemakers and heart valves are examples. Most Class III products require premarket approval (PMA) based on substantial evidence that they are safe and effective for their intended uses. The
Chapter Twenty Health Devices 421
Historical Perspective
FDA jurisdiction over devices began with passage in 1938 of the Food, Drug, and Cosmetic Act (FD&C Act), which required that devices be safe and labeled with adequate directions for use. Premarket approval from the FDA was not required. The burden of proving that a device was dangerous or ineffective fell upon the FDA. To stop the marketing of a dubious device, the agency often had to expend much time, effort, and expense for research and court procedures. As legitimate devices became more sophisticated and more numerous, it became clear that the 1938 law did not adequately protect the public. The 1976 Congress amended the law to require that all devices be safe and effective, that new devices have premarket clearance, and that manufacturers bear the burden of proof. The Medical Device Amendments divided medical devices into three classes (I, II, and III) based on the principle that the greater the potential hazard, the more rigorous the regulatory requirements and the higher the class.4 The Medical Device Reporting Act (1984) required for the first time that adverse reactions and significant malfunctions be reported to the FDA. Within the first 3 years after it took effect, 1554 device-related deaths and 21,176 nonfatal injuries were reported.5 In 1989 the General Accounting Office reported that only about 25% of the expected number of device manufacturers had filed problem reports. FDA inspectors found that many firms were unaware of the reporting requirement, and some had records of deaths and serious injuries that had not been reported to the FDA. After it became apparent that the 1976 law needed further reform, Congress passed the Safe Medical De- vices Act of 1990. This extended the reporting require- ment to hospitals, nursing homes, and outpatient facilities
(except physicians’ offices), and also requires notification by manufacturers. The 1990 law also enables the FDA to order an immediate recall of any device it deems unsafe and to initiate large civil penalties for violations of the act (see Chapter 25). While underreporting of device- associated problems has decreased, the result is not en- tirely positive. As of April 2011, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database of adverse events had accumulated more than 9.6 million entries, far more than the agency can usefully manage. Knowledgeable observers believe that reporting should be limited to problems that may contribute to serious injuries and deaths.6 Criticism by Congress and others of the FDA’s medical-device regulation has suggested that the public is not adequately protected. The Government Accountability Office (GAO)7 reported that in fiscal years 2003 through 2007, more high-risk devices entered the marketplace through 510(k) clearance than through PMA. Zuckerman and others8 found that from 2005 through 2009, only 21 of 113 (19%) devices that had been recalled for serious potential health problems or death had been approved by the stringent PMA process. In response, the FDA is considering tighter 510(k) regulation. The FDA also requires manufacturers of new devices to document that they have tried to design their devices so that user errors are minimized. Robert Mosenkis,9 who for many years served as editor of Health Devices (a magazine similar to Con- sumer Reports but written for large purchasers of medi- cal devices), believes that the quality of medical devices generally is high and that “the device industry is . . . very effective at policing itself, if only because of the large awards being made in liability suits.”
Device Regulation
evidence must include human clinical trials as well as physical, scientific, biologic, and engineering tests. The length, complexity, and cost of the approval process may discourage the development of “breakthrough” products, particularly by smaller companies.
vision proDucts anD services
The ability to see well depends mainly on the shape of the cornea and eyeball (Figure 20-1), the status of the lens of the eye, and the condition of the retina. The common visual problems include:
nearsightedness (myoPia) is a condition in which close objects can be seen clearly, but distant ones cannot.
farsightedness (hyPeroPia) is a condition in which distant objects are usually seen clearly, but close ones are not brought into proper focus.
astigmatism is an irregularity of the front surface (cornea) of the eye, which causes vision to be blurred at all distances.
PresbyoPia occurs when the lens of the eye loses its elastic- ity and becomes unable to focus sharply on close objects. This happens gradually as people get older and is usually noticeable in the early- to mid-40s. The change in the lens enables people with a certain amount of nearsightedness to read without glasses, but they will still need glasses for distance vision. Everyone else will need corrective lenses for reading.
CataraCts are a clouding of the lens that distorts entering light, causing blurred or hazy vision. Cataracts usually develop slowly.
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Figure 20-1. How light rays are focused. With normal vision the rays converge on the retina at the back of the eye (point N). In nearsightedness the eyeball is elongated, causing the rays to focus in front of the retina (point M). In farsightedness the eyeball is too short, and the rays focus behind the retina (point H).
Retina
Lens
Cornea
Light source Hm n
glauComa is a buildup of excess fluid within the eye, which causes pressure that can damage the optic nerve. Untreated glaucoma can cause blindness.
age-related maCular degeneration is an irreversible disorder in which the light-sensing cells in the macula (central zone of the retina) deteriorate, leading to loss of central and detailed vision.
The degree of sharpness of visual acuity is expressed as a fraction. The normal value, 20/20, means that the person can see clearly at 20 feet what the average person can see at 20 feet. Someone with 20/100 vision would have to be as close as 20 feet to see what someone with normal vision could see at 100 feet. The legal definition of blindness is vision that cannot be corrected to bet- ter than 20/200. About half the people in America and about 95% of those older than 45 wear glasses or contact lenses. Friedlander and Donev10 note that corrective lenses do not “strengthen” or “weaken” the eyes and do not make the wearer “addicted” to wearing glasses. They also note that people rarely develop headaches because they need glasses, and that the few who do usually are farsighted and went for prolonged periods without wear- ing glasses.
Eye-Care Professionals The three main types of professionals involved in vision care are ophthalmologists, optometrists, and opticians. Ophthalmologists are physicians who have complet- ed several years of postgraduate residency training. Un- like optometrists, they can perform surgery and have full prescribing privileges. Some ophthalmologists restrict their practice to the medical and surgical treatment of the
eye. Increasing numbers, however, are doing refractions and selling eyeglasses and contact lenses. Optometrists (O.D.s) are trained to examine the eyes and related structures to detect vision problems, eye disease, and other abnormalities. They principally per- form vision examinations for the purpose of prescribing glasses and contact lenses. Optometrists do not perform surgery (except in Oklahoma) but can use drugs to dilate the pupils so they can see the retina better during an eye examination. They are also permitted to use drugs to treat certain eye diseases. Most optometrists are gradu- ates of one of the 20 accredited colleges of optometry in the United States. Admission to these schools requires a minimum of 3 years of undergraduate work, although, as in medicine, few students enter with less than a bac- calaureate degree. Optometry school takes 4 years. A few states require a 6-month internship. All states require passage of written and clinical examinations. In many states, a national board examination may be substituted for the state board examination. Currently there are about 30,000 practicing optometrists in the United States. Opticians are technicians who make and fit eyeglass- es and contact lenses as prescribed by optometrists and ophthalmologists. Opticians do not examine eyes and are not legally authorized to prescribe lenses. They may be trained through apprenticeship or a 2-year community college or vocational school program and are licensed in about half the states. The American Board of Opticianry/ National Contact Lens Examiners offers certification in dispensing opticianry and contact lens–fitting. Licens- ing and board certification may indicate that an optician has had appropriate training, but they do not guarantee this.
Chapter Twenty Health Devices 423
Professional Evaluation For people with no known eye problems, the American Optometric Association (AOA)11 recommends examina- tions at age 6 months and 3 years; every 2 years from age 6 through 60; and annually thereafter. This timetable will enable detection of some changes that have not become apparent to the individual, such as the early stages of presbyopia. People with known eye problems may need to be checked more often. The U.S. Preventive Services Task Force (USP- STF)12,13 recommends vision screening for all children at least once between the ages of 3 and 5 years to detect the presence of amblyopia (poor vision in an eye that is otherwise physically normal). However, for other age groups it has concluded that the optimal frequency of screening for visual problems is unknown. A complete eye examination usually takes 30 to 45 minutes and includes:
• A review of the patient’s general health and eye history. The presence of diabetes or high blood pressure is signifi- cant because they can damage retinal blood vessels if not controlled.
• Examination of the outside and inside of the eyes to detect abnormal conditions. A slit lamp is used to check the outer structures and the front of the lens of the eye. An ophthal- moscope is used to check the back of the eye (the retina and part of the optic nerve). Dilating the pupils with drops enables the doctor to see more of the retina.
• Tests to determine eye coordination and eye-muscle function.
• Measurement of the eye’s fluid pressure to check for glaucoma. The American Academy of Ophthalmology14 recommends screening for glaucoma as part of the com- prehensive adult medical eye evaluation, starting at age 20, with the frequency depending on an individual’s age and other risk factors for glaucoma. However, the USPSTF15 is uncertain whether screening does more good than harm.
• Visual acuity testing to determine the ability to see clearly at various distances. An eye chart is used to test distant vi- sion; a printed card is used to test near vision (the ability to read small print).
• Visual field testing to check peripheral vision. The doctor may do this by asking whether you can see the doctor’s fingers as they move to various locations near your head. Mechanized testing is also available.
• Refraction to determine which lenses can correct your vision problem. This is usually done with a phoropter, a device that you look through while the doctor switches lenses to determine which ones enable you to see the best.
The cost of an eye examination depends on the setting and what tests are done. Optometrists tend to charge $50 to $100 for a routine examination; ophthal- mologists generally charge more. Because the cost can
vary considerably, it is wise to find out in advance what it will be and how much insurance will cover.
Selection of Eyeglasses When an examination determines that glasses are indicated, the doctor prepares a prescription for the appropriate type of lenses. The prescription contains numbers for each eye that represent the lens power and rotation needed to enable the eye to focus for near and distance vision. Many Web sites explain how to interpret prescriptions. Glasses may be purchased from an ophthalmologist, optometrist, optician, or though the Internet. The cost depends on the nature of the lenses, the type of frame, and the vendor’s markup. Some chains have sales during which they offer complete glasses for considerably less. Lenses are classified as single-vision (which focus at only one distance), bifocal (two lenses in one); trifo- cal (three lenses in one); or progressive (multifocal with no obvious dividing line between different portions of the lens).They are made of plastic, glass, or a laminated combination of plastic and glass. Most lenses today are plastic. The FDA requires that all lenses be resistant to shattering on impact. Plastic lenses are more easily scratched but weigh less than glass. Tinting, antiscratch coatings, and anti-glare lenses are available, usually at an extra charge. Tinting is available in many colors, with sunglass tints for outdoor wear. The color can be uniform or can lighten gradually from top to bottom. Photochromatic lenses respond to ultraviolet light, becoming darker in sunlight and lighter in shade. Such lenses take a minute or two to make their changes. They do not work as well in an automobile because sufficient ultraviolet light may not filter through the windows. To select frames, it is also necessary to know the pupillary distance (PD)—the number of millimeters between the pupils of the eyes. Some practitioners will put this on the prescription, but those who sell glasses seldom do so because that enables the buyer to obtain them through the Internet. Most practitioners will dis- close the PD when asked, but there may be an extra fee involved. In 2010 Consumer Reports16 published the results of a survey of about 31,000 of its subscribers who had purchased prescription glasses within the previous 21/2 years. The survey showed (a) readers were more satis- fied when they bought their glasses from independent opticians, private optometrists, and ophthalmologists rather than from large optical chain stores; (b) the median cost at big chains ($155) was lower than the average at independent optical shops ($211) and eye doctors’ offices
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($212); and (c) the chain rating highest in customer satisfaction was Costco. When purchasing locally, it is prudent for glasses to be checked after they have been received from the dispenser to be certain that the pre- scription has been accurately filled. Prescription glasses can be also obtained through Web sites that enable the buyer to choose a frame and insert the relevant prescription numbers into an interac- tive page so lenses can be fitted. Dr. Stephen Barrett has found that Zenni Optical (www.zennioptical.com) sells high-quality prescription glasses for less than 25% of the cost of comparable products at retail outlets, with single- vision glasses as low as $6.95 plus shipping. Placing an order is simple if a previously purchased frame can be used to determine the appropriate dimensions. If not, it may be advisable to purchase one pair locally. Ready-to-wear reading glasses are available in many stores for $10 to $15. These come in different strengths and can be tried out in the store. They may be adequate (though not optimal) for people who are nearsighted or presbyopic and have no astigmatism. They should not be used as a substitute for periodic professional examinations.
Contact Lenses Contact lenses are plastic or glass discs worn in front of the pupil and in contact with the cornea. They adhere to the cornea by capillary action on the normal layer of tear fluids. Not everyone can wear them, and they do not correct all vision problems. Except for extreme nearsightedness, vision is no better with contacts than with regular glasses. Many individuals use them for cosmetic reasons, and they also serve a useful purpose in athletics. Modern contact lenses developed after it was un- derstood that the outer covering of the eye (cornea) required a steady supply of oxygen from the air. This led to development of lightweight glass lenses small enough to permit oxygen dissolved in the tears to reach the un- derlying cornea. In the late 1950s a soft plastic lens was created that was flexible, absorbed water, and permitted the cornea to breathe more normally. Extended-wear lenses introduced in the 1970s were more convenient but turned out to cause potentially serious infections if not properly cleaned. The more recently developed gas-permeable lenses permit more oxygen to reach the cornea and are less prone to cause infections. Disposable extended-wear contacts offer the same advantages plus additional convenience. The price charged for contact lenses usually includes the cost of the lenses, the amount of time spent to fit them and to provide follow-up care, the nature of the
warranty, and the value of the services as determined by the practitioner. Many sellers guarantee to issue a refund or furnish a pair of glasses if the buyer is unable to adapt to the use of contacts. Hard lenses and gas-permeable lenses are the most economical and durable. Soft lenses are the most com- fortable and can be worn longer, but their care is more difficult. Table 20-1 summarizes the advantages and disadvantages of currently marketed contact lenses. Examinations for prescribing contact lenses are conducted by optometrists and ophthalmologists. They include tests for corneal sensitivity and lacrimal (tear) secretion, a refraction to determine the strength of the lenses, and measurement of the eye’s curvature to de- termine the type of lens needed. The FTC’s Eyeglass Rule requires the eye specialist to give a copy of the prescription to the patient when requested after the examination. Once contact lenses have been purchased, the di- rections for use, maintenance, storage, and cleaning should be followed scrupulously. Serious infections and damage to the eye can result from improper main- tenance and from wearing lenses for longer periods than recommended.
Sunglasses Many studies have shown that prolonged exposure to the sun’s rays increases the chances of developing cata- racts, retinal degeneration, cancer of the eyelids, and photokeratitis, a temporary but painful burn of the eye’s surface (sometimes called snow blindness or welder’s flash).17 The sun’s glare can also interfere with comfort and the ability to see clearly. Reducing glare can make driving and outdoor recreational and occupational ac- tivities safer.
√ Consumer Tip
Shopping for Eyeglasses • Obtain a thorough examination by a competent ophthalmologist or optometrist.
• The Federal Trade Commission (FTC) Eyeglass Rule requires that consumers receive a copy of the pre- scription. This makes it possible to shop to compare prices.
• Wear the glasses for a few days, and have them checked if they do not feel right.
• If the glasses seem defective, do not hesitate to ask the vendor to rectify the problem.
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The AOA says that sunglasses have gone from a fashion accessory to a necessity. There are three main types. Polaroid lenses cut glare and are especially useful when driving or boating. Photochromatic lenses change color with varying light intensity. Mirrored lenses reflect rather than absorb light and are primarily useful when there is intense glare from snow or water. However, they show dirt and are hard to clean. The AOA advises consumers to insist that sunglasses block out at least 99% of ultraviolet radiation; screen out at least 75% of visible light; be perfectly matched in color and free of distortion; and have lenses that are gray (the preferable color), green, or brown.18 Prescription lenses may be advisable for people with vision problems, but clip-on or overfitting sunglasses may be an acceptable substitute. Color can be checked by looking at the glasses against a white background. Distortion can be observed by holding them at arm’s length and looking through them with one eye at something with a rectangular pat- tern. Any distortion will be apparent as the glasses are moved back and forth or rotated. To be sure the lenses
block enough light, try them on in front of a mirror. If your eyes are clearly visible through the lenses, the lenses are probably not dark enough for glare reduction and comfort. This test does not apply to photochromatic lenses.
Pinhole Glasses Many entrepreneurs have marketed “pyramid” or “pin- hole” glasses consisting of opaque material with multiple slits or perforations. The mechanism involved has been known for centuries and was used before glass lenses were invented. Light passing through a small hole (or holes) is restricted to rays coming straight from the viewed object; these rays do not need focusing to bring them to a point. Modern promoters claim their products are better than conventional lenses. Worrall and others19 state that although both reduce the focus effort needed to read, pinhole glasses are much less useful because they re- strict contrast, brightness, and the field of view. Worn as sunglasses, they can even be harmful because the holes allow damaging ultraviolet rays to reach the eye.
Lens Type
Rigid gas-permeable (RGP) Made of slightly flexible plas- tics that allow oxygen to pass through to the eyes.
Daily wear soft Made of soft, flexible plastics that allow oxygen to pass through to the eyes.
Extended-wear Available for overnight wear in soft or RGP lenses.
Extended-wear disposable Soft lenses worn for 1 to 6 days
and then discarded.
Planned replacement Soft daily wear lenses that are replaced on a planned schedule, most often either every 2 weeks, monthly, or quarterly.
coMparison oF contact lenses
Table 20-1
Source: American Optometric Association.20
Advantages
Excellent vision; short adaptation period; comfort- able to wear; correct most vision problems; easy to put on and to care for; durable with a relatively long life; available in tints (for ease in handling and for cosmetic purposes) and bifocals.
Very short adaptation period; more comfortable and more difficult to dislodge than RGP lenses; available in tints and bifocals; great for active lifestyles.
Can usually be worn up to 7 days without re- moval.
Require little or no cleaning; minimal risk of eye infection if wearing instruc tions are followed; available in tints and bifocals; spare lenses available.
Require simplified cleaning and disinfection; good for eye health; available in most prescriptions.
Disadvantages
Require consistent wear to maintain adap- tation; can slip off center of eye more easily than other types.
Do not correct all vision problems; vision may not be as sharp as with RGP lenses; require regular office visits for follow-up care; soil easily and must be replaced.
Do not correct all vision problems; require regular office visits for follow-up care and monitoring.
Vision may not be as sharp as with RGP lenses; do not correct all vision prob- lems; handling may be more difficult.
Vision may not be as sharp as with RGP lenses; do not correct all vision prob- lems; handling may be more difficult.
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Visual Training “Vision therapists” claim to strengthen eyesight through a series of exercises and the use of eyeglasses. They emphasize exercising hand-eye coordination, watching a series of blinking lights, focusing on a string of objects, and sleeping in a certain position. Some optometrists claim that vision therapy is valuable for children with learning disabilities. The American Academy of Pedi- atrics and several other professional groups have stated that eye exercises and other types of vision therapy have no proven value for learning disabilities.21
Cataract Surgery A cataract is an opacity of the lens of the eye that impairs vision. The cause is unknown, but diabetes and expo- sure to ultraviolet light are important risk factors. Low intake of antioxidants in the diet may also be a factor.22,23 Cataracts can cause double or blurred vision, sensitiv- ity to light and glare, less vivid perception of color, and frequent changes in eyeglass prescription. Cataracts develop in about 400,000 Americans each year, but most remain small and never need treatment. Cataract surgery is the most frequently performed operation on people age 65 or older. More than 1 million cataract extractions are performed each year. During the operation, the lens is removed from its supporting capsule either by pushing it out or by phacoemulsifica- tion (shattering it with ultrasound and sucking out the remnants). A plastic intraocular lens is then placed inside. The procedure takes 20 to 30 minutes and does not re- quire hospitalization. About 95% of patients emerge with better than 20/40 vision with eyeglasses (the minimum
required for a driver’s license). Eyeglasses are still needed for reading because the inflexible lens focuses at only one point, usually in the distance. The operations are not risk-free. A small percentage of patients develop swelling or detachment of the retina, glaucoma, infection, or displacement of the intraocular lens. About one-third develop clouding of the lens cap- sule, which can be remedied by cutting a hole through the capsule with a laser. Consumer Reports on Health24 cautions against having the operation unless a cataract hampers daily activities. This usually does not occur un- less a person’s visual acuity drops to 20/50 with glasses. In 2003, the FDA approved the Array multifocal intraocular lens, which, by changing its shape, enables the person to focus on both close and distant objects.25 However, some patients see halos around lights, and one study found that overall user satisfaction was no greater than that with standard intraocular lenses.26
Refractive Surgery It is possible for surgery to permanently alter the refrac- tive state of the eye by either making appropriate corneal incisions or by removing an appropriately shaped disc of corneal tissue. These change the shape of the cornea and enable light rays to converge properly on the retina. Various operations can reduce or correct nearsightedness, farsightedness, and astigmatism. Newer techniques involving computerized as- sessment, precisely calculated tissue removal, and lasers have made refractive surgery more predictable.27 Computerized topography can be used preoperatively to determine the best procedure and postoperatively to determine whether additional correction might be indicated. For people who are severely nearsighted or farsighted or who are experiencing age-related changes in the natural lens of the eye, an alternative approach is replacement of their natural lens with an artificial lens that is more appropriately shaped. The most common type of refractive surgery is laser-assisted in situ keratomileusis (LASIK). In this procedure, a knife called a microkeratome is used to cut a thin, superficial corneal flap, which is folded back. A computer-controlled laser then vaporizes some of the underlying corneal tissue and the flap is replaced.28 Most patients are pleased with the results of their refractive surgery, but complications can occur. Some patients develop glare, halos, and/or double vision that can seriously affect nighttime vision. Undercorrection and overcorrection are relatively common but can usu- ally be corrected by further laser surgery. Dry eye is common but usually lasts only about 2 months. It can be treated by frequent applications of artificial tears and/
A Deluded Physician William Horatio Bates received his M.D. degree from Cornell University in 1885. He was an attending physician at the New York Eye Infirmary and taught ophthalmology at the New York Postgraduate School from 1886 to 1891. In 1920 Dr. Bates wrote Cure of Imperfect Eyesight by Treatment without Glasses. He stated (incorrectly) that the lens of the eye was not a factor in accommodation, and that refractive errors were simply “strain due to an abnormal condition of the mind” that could be helped through various prescribed eye exercises. He also advocated looking directly at the sun for short moments to “strengthen” the eyes. Although his methods have no validity, they are still advocated by a few practitioners today. Staring directly into the sun can seriously damage the retina.
Historical Perspective
Chapter Twenty Health Devices 427
or by blocking of the pathway through which tears drain from the eye to the nose. Infection is very rare but can be catastrophic. Appropriate preoperative and postoperative antibiotics and the use of sterile precautions reduce the likelihood of infection. People contemplating refractive surgery should discuss the potential benefits and risks with an oph- thalmologist who is well regarded by the medical and optometric communities. Although the procedures have a low incidence of complications, the risk involved may not justify their use if adequate vision can be achieved with eyeglasses or contact lenses. Individuals who wish to have laser surgery should seek someone who is well trained and thoroughly experienced.
Regulatory Action The case of the Lasik Vision Institute (LVI) illustrates why careful provider selection is important. LVI has widely advertised LASIK surgery for $299 per eye. About 10 years ago, however, television teams using hidden cameras found that this fee was difficult or impossible to get and that the average price per eye was about $1800. Several investigators concluded that the advertised price was intended to lure patients into consultations at which much higher prices were quoted. LVI was a subsidiary of Musa Holdings, Inc., of Lake Worth, Florida, which also operated Eyeglass World. In 2001, the Florida Attorney General announced that Eyeglass World would pay $500,000 and adopt an arms-length relationship with its affiliated optometrists to settle allegations of unlawful marketing practices. In 2003, LVI signed a consent agreement to settle FTC charges that it had failed to substantiate claims that its LASIK surgery permanently eliminated the need for glasses and contacts, reading glasses, or bifocals. The FTC also charged that LVI had falsely claimed that consumers would receive a free consultation to determine their candidacy for LASIK. Instead, after an initial meeting with an LVI representative, consumers were required to pay a $300 deposit before they were told of the risks associated with the surgery or whether they were eligible candidates.29
Hearing aiDs
Hearing loss affects more than 35 million Americans, about half of whom are older than 50. The National Institute on Deafness and Other Communication Dis- orders estimates that only about 20% of people who could benefit from wearing a hearing aid actually wear one.30 The reasons for not using a hearing aid include (a) lack of awareness of problem, (b) cost, (c) not wishing
to call attention to disability, (d) dealer practices, (e) sounds when amplified are still not clear, (f) difficulty in manipulating controls, and (g) not knowing where to go for help.31 Hearing loss is most common among the elderly. One person in four older than 65 years and one in three older than 75 years experience this problem. Noise-induced hearing loss is common among young and middle-aged people exposed to high levels of noise from sources such as motorcycles, snowmobiles, powerboats, radios with headphones, poorly designed telephones, live rock band music, and various types of occupational exposure.32 Types of Hearing Loss There are two types of hearing loss: sensorineural and conductive. Sensorineural deafness, also called percep- tive or nerve deafness, is caused by damage to the audi- tory nerve, which connects the inner part of the ear to the brain. Nerve deafness can result from birth defects, illnesses that produce a high fever, overexposure to high noise levels, use of certain medications, head injuries, vascular problems, and tumors. Nerve deafness often is related to aging and is the most common reason for using a hearing aid. In some cases, no cause is apparent. In conductive deafness, which is less common, sound waves cannot be transmitted to the auditory nerve. Conductive deafness is related to the outer and middle portions of the ear and can be caused by (a) impacted wax in the external ear; (b) injury to the eardrum by an explosion, blow to the ear, infection, or sharp imple- ment; or (c) arthritic disease, middle ear infection (otitis media), or another condition that prevents the three tiny bones of the inner ear from vibrating. Some individuals have “mixed” hearing loss—both conductive and sensorineural. Elderly individuals with a hearing loss often have damage to the auditory nerve as well as a defect in the ear mechanism that relays sound to that nerve. Some impairments can be medically or surgically treated. If there is partial hearing, a hearing aid may be effective. People with a hearing loss may find that words are difficult to distinguish; sounds seem muffled or subdued; and high-pitched sounds, such as the ticking of a watch, dripping of a faucet, or high tones of a musical instru- ment, are difficult or impossible to hear. Other signs of possible impairment include asking people to repeat themselves, turning up the volume of a radio or television set, favoring one ear, or straining to hear. Many people with a hearing loss also have tinnitus (continual hissing or ringing of their ears). If a hearing loss is suspected, a physician should be consulted. In most cases an evalu- ation by an otolaryngologist is advisable.
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Professional Evaluation An evaluation for suspected hearing loss should include (a) a review of the symptoms and past medical history, (b) examination of the ears and throat, (c) an audiometric test, and (d) other special tests as needed. Audiometry is performed in a soundproof room, usually by an audiolo- gist. Some otolaryngologists employ one in their office, whereas others refer the patient elsewhere. During the test, various tones and levels of sound are transmitted to the patient through an earphone. The patient signals to the tester when sounds are heard, and the tester records the information on a graph (audiogram). The information is analyzed and the hearing level, measured in decibels (dB), is established. When all tests are completed, the otolaryngologist or audiologist informs the patient of the nature and extent of the problem, if any, and whether a hearing aid might be helpful. Some common sounds and their decibel values in- clude: rustling leaves (20 dB), whisper at 5 feet (30 dB), conversational speech at 3 feet (60 dB), loud radio music (65 dB), shouted speech (90 dB), a loud amplified rock band (110 dB), and a jet engine at 100 feet (140 dB). The decibel scale is logarithmic, which means that a jet en- gine is much more than twice as loud as rustling leaves. Hearing loss is also expressed in decibels. Someone with a 30 dB loss, for example, could not hear someone 5 feet away who is whispering. Table 20-2 indicates how the levels of dB loss relate to the possible usefulness of a hearing aid.
Types of Hearing Aids A hearing aid is a miniature, battery-powered, amplifier system with a microphone that picks up sound waves and a speaker that sends them to the ear canal. Monaural sys- tems serve one ear, whereas binaural systems serve both. To benefit from a hearing aid it is necessary to have some
degree of hearing. Most hearing aids work similarly, although their designs differ somewhat. Because hearing losses vary in pattern and severity, no single hearing aid is right for everyone.33 The most commonly used types are (a) completely-in-the-canal, (b) in-the-canal, (c) in- the-ear, and (d) behind-the-ear (two types).34 Behind-the- ear devices are attached via a thin clear plastic tube to either a molded silicone earpiece that fits into the canal or an acrylic earpiece that lies in the canal but permits the canal to be ventilated. Prescription hearing aids range from about $700 to $4000 per ear. Hundreds of models are available. The price depends mainly on the sophistication of the elec- tronic circuitry. Multichannel adaptive models can be set to amplify certain frequencies and lower the volume of others. Digital programmable models can be adjusted through a computer hookup. Digital sound models use a microprocessor to provide the “cleanest” sound pos- sible. Some have a manual volume control; some have completely automatic volume control; and some have additional volume control via a hand-held transmitter. Rezen and Hausman35 have noted that some dealers charge twice as much for two hearing aids as they do for one. If the price for one includes compensation for the dealer’s time, doubling it is unfair because it takes no more time to provide instruction for two than it does to provide instruction for one. They suggest asking the dealer how much each component of the sales package costs.
Hearing Aid Professionals Two categories of hearing aid professionals are regulated by licensure or certification in all states.
audiologists are trained to diagnose a wide variety of pathol- ogy and underlying medical conditions of the hearing and balance systems and to refer these cases for appropriate
Level of Loss
25 to 40 decibels
41 to 55 decibels
56 to 80 decibels
81 or more decibels
signiFicance oF Hearing loss levels
Table 20-2
Description
Mild
Moderate
Severe
Profound
Effect
Difficulty understanding normal speech
Difficulty understanding loud speech
Can understand only ampli- fied speech
Difficulty understanding amplified speech
Need for Hearing Aid
Needed in some situations
Frequently needed
Needed for all communication
May need to supplement hearing aid with lip-reading, aural rehabilitation, or sign language
Source: American Association of Retired Persons.28
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medical or surgical treatment. Audiologists must have a masters or doctoral degree in audiology. The doctoral degree (Au.D.) typically requires 4 years of post-college training. In 2007, some states began requiring this for entry into the field, but all states are expected to do so eventu- ally. Audiologists can also earn a Certificate of Clinical Competence in Audiology (CCC-A) from the American Speech-Language-Hearing Association and can become certified by the American Board of Audiology.
hearing instrument sPeCialists are limited to testing hearing solely for the purpose of fitting hearing aids. The licens- ing requirements vary considerably from state to state but typically require a 2-year undergraduate training program. Those who are licensed or registered by a state can become certified by the National Board for Certification in Hearing Instrument Sciences after completing 2 years of dispens- ing experience and passing an examination. Those who are certified can place the letters BC-HIS after their name.
Selecting a Hearing Aid The best way to select a dealer is probably through a physician’s recommendation. Audiologists have far more training than hearing aid specialists. Your family doctor or an otolaryngologist may be able to make a suitable recommendation. Some otolaryngologists employ a qualified person in their office who fits hearing aids. Some medical centers charge a fee for testing and fitting but sell the devices at their cost. Obtaining a proper fit may require several visits to the dealer. Adjusting to the device may take weeks or months. Before purchasing, it is prudent to rent it for a trial period. Many vendors offer a trial rental or purchase- option plan, usually for 30 days. Buyers should not be influenced solely by the price or appearance of a hearing aid, but should obtain answers to these questions:
• What is the quality of the sound? • Does the aid help you to understand speech in quiet places? In noisy places?
• Is the aid comfortable to wear? • Are the controls easy enough to operate? • Does the price include the initial testing, the device itself, the fitting, and follow-up costs? If a device proves unsat- isfactory, what costs will be involved if it is returned?
• Who will provide maintenance and repair services? What will they cost?
• What are the warranty terms? • Does the dealer offer an aural rehabilitation program (a program that teaches how to use facial expression and other visual cues to help interpret what people say)?
In 2009, Consumer Reports36 evaluated four brands of hearing aids that are sold without a prescription. Three that cost about $500 could amplify sound but lacked
features that most people require for satisfactory per- formance. The fourth, which sold for $34.50, performed extremely poorly.
Government Regulation The FDA’s Hearing Aid Rule, promulgated in 1977, requires practitioners to advise patients to see a physi- cian, preferably one specializing in diseases of the ear, before purchasing a hearing aid. It also requires that the patient obtain a medical evaluation of hearing loss within 6 months before obtaining a hearing aid or sign a waiver. Patients younger than 18 must be medically evaluated before a sale can be legally made. Although hearing aids have been marketed door-to-door and by telephone (sometimes with a survey or prize offer), reputable dealers do not solicit this way. Patients must also be advised to consult a physician or ear specialist if any of the following conditions are discovered: visible congenital deformity of the ear; his- tory of active drainage from the ear within the previous 90 days; acute or chronic dizziness; one-sided hearing loss within the previous 90 days; evidence of wax ac- cumulation or the presence of a foreign body in the ear canal; pain or discomfort in the ear; or an audiometric air-bone gap equal to or greater than 15 dB at tonal frequencies of 500 Hz, 1000 Hz, and 2000 Hz. (The air- bone gap is the difference between the air-conduction and bone-conduction test results.) Buying a hearing aid through the Internet is unwise because this bypasses the services needed to fit the device to the individual.
HuMiDiFiers anD vaporizers
Humidifiers add moisture to room air by producing a mist. This may help relieve a dry, hacking cough or discomfort from an acute respiratory infection or dry air, especially in the winter heating season. However, harmful bacteria and molds can multiply in the water tank of a humidifier and be blown into the air. For this reason the water should be changed daily, the device should be regularly cleaned with vinegar and disinfected with bleach, and filters should be replaced according to the manufacturer’s instructions. Tabletop models can handle one or two rooms. Con- sole models can raise humidity throughout many rooms. In-duct models require less maintenance and can service an entire house but are more expensive. Evaporative units are usually the most efficient. Warm-mist units are quieter. Nebulizers may emit white dust. A humidistat is essential to avoid overhumidification. Dual-mist models enable the user to choose cool or warm mist.
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Vaporizers, which cost less, boil water to create steam rather than the mist produced by humidifiers. They should be cleaned regularly according to the manufac- turer’s instructions. They have become uncommon but are still available.
personal eMergencY response sYsteMs
A personal emergency response system (PERS)—also known as medical emergency response system or medi- cal alarm—enables the user to call for help. There are three components: a small, battery-powered transmitter that is worn like a wristwatch or a pendant; a base sta- tion connected to the user’s telephone; and an emer- gency response center that monitors calls. Pressing the transmitter’s help button signals the base station, which automatically contacts one or more preprogrammed numbers. Most systems can make contact even if the user’s telephone is off. The monitoring center usually tries to call back to find out what is wrong. If the center is unable to reach the person or if help is needed, it will try to reach a designated person (friend, family member) to follow-up the call. If a medical emergency appears evident, an ambulance or other emergency provider will be dispatched. There are two types of emergency response centers. Provider-based centers usually are located in the user’s local area and are operated by hospitals or social service agencies. Manufacturer-based operations usually have one national center. The systems can be purchased, rented, or leased. The purchase prices normally range from $200 to more than $1500. However, some consumers have paid several thousand dollars. There is also a small installation fee, and a monthly monitoring charge of $10 to $30. Monthly rental fees range from $15 to $50 and usually include the monitoring service. Lease agreements can be long-term or can include an option to buy. Some contracts have a cancellation charge. A local social agency might be the best source of referral to prospective vendors. It is advisable to inves- tigate several systems before making a decision. The FTC37 recommends asking the following questions:
• What kind of services and features does it include? • Is the monitoring center open 24/7? What kind of training do staff members receive?
• What’s the average response time, and who gets alerted? • Will the same system be usable with other response centers if the user moves?
• What’s the repair policy? What happens if a replacement is needed?
• What are the initial costs? What costs are ongoing?
latex allergY
When exposed to latex or latex dust, sensitized persons can develop hives; nasal and eye irritation; asthma; and anaphylaxis, a life-threatening condition in which the breathing passageways swell and close. Latex is a com- mon component of disposable gloves, intravenous tub- ing, syringes, stethoscopes, catheters, condoms, dress- ings, bandages, and other medical supplies. Gloves are the most significant source because they are frequently used, and the powder used to line some of them can absorb latex proteins and become airborne. Asthmatic reactions have occurred among people who did not use gloves but merely inhaled latex-containing dust. Medical and dental procedures on sensitized individuals may be complicated by anaphylactic events, as may the use of latex pacifiers by infants. Allergic reactions to latex became a significant pub- lic health problem in the late 1980s, particularly among health-care workers. The incidence peaked during the mid-1990s but decreased after manufacturers switched to low-allergy, powder-free gloves.38 About 1% of the general public and 5% to 15% of health-care workers and others exposed to latex on their jobs have become sensitized. Some have even been forced to terminate their careers for this reason. Since 1998, latex-containing medical devices that can come into contact with humans must be labeled: “Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.”39 Latex allergy can be suspected from the patient’s his- tory and confirmed by immunologic testing, preferably by a physician with considerable experience in this area. People who have been diagnosed as allergic should carry an identification card or bracelet and a self-injectable adrenalin (epinephrine) device.
Dubious Water puriFier proMotions
Water treatment devices may be useful for removing con- taminants or improving the water’s taste.40 However, the water treatment business has been rife with fraud. Com- panies that offer free testing of home water supplies for “contamination” are interested in selling water-treatment devices whether needed or not. Consumer Reports41 has noted that some in-home demonstrators add chemicals to a prospective customer’s tap water to change its color or to form particles that supposedly indicate contamination. The “Investigate Carefully” Consumer Tip box suggests ways to avoid being misled. Some entrepreneurs try to sell devices without hav- ing the water tested. Multilevel marketers typically cite a few localized problems to suggest that water pollution is
Chapter Twenty Health Devices 431
widespread. Other entrepreneurs notify people by mail or telephone that they have been selected to win a prize. To “qualify,” however, they are required to purchase a water treatment device or other products costing hundreds of dollars. The price is invariably more than similar mer- chandise would cost if obtained from a legitimate firm. In many cases no device is delivered. Regardless, it is never a good idea to reveal your credit card number to an unfamiliar solicitor. A 1999 federal law requires water utilities serving more than 10,000 people to explain what is in the water exiting their water-treatment plant and whether it is within government safety limits. People with further concerns can call the Environmental Protection Agency (EPA)’s Safe Drinking Water Hotline (800-426-4791) or consult their local or state health department. The Consumer Tip Box gives further suggestions. The UC Berkeley Wellness Letter42 states that many people drink bottled water because they assume it is “more natural, purer, more healthful, and better tasting.” About 25% of the bottled water in the United States comes from tap water and municipal systems. All bottled waters are now strictly regulated by the EPA and the FDA for purity and safety. Genuine spring water is always identified as such. The FDA does not regulate water purifiers as medical devices. If your tap water meets current federal standards, there is no need to consider drinking bottled water.
spinal DecoMpression MacHines
“Spinal decompression” machines offer an expensive, high-tech form of mechanical traction. The procedure is also referred to as vertebral axial decompression or mechanized axial spinal distraction therapy. The devices are computer-driven tables designed to apply a stretch- ing force along the axis of the spine. Proponents claim that these devices can relieve low back pain by decom- pressing herniated discs, improving the flow of nutrients into the disc, rehydrating dried-out discs, and thereby helping to restore the disc structure. However, no such effects have been demonstrated. They may provide relief in cases of back pain that would probably respond to simpler forms of traction or other methods, but a course of treatment is likely to cost several thousand dollars.43
QuacK Devices
The FDA44 has grouped quack devices into nine general categories. The following devices can be considered complete fakes:
• Figure enhancers, such as bust developers and spot- reducers.
• Arthritis and pain relievers claimed to relieve all types of pain.
• Sleep aids claimed to produce electrical impulses that cause natural sleep.
• Mail-order sex aids claimed to cure impotence or frigidity. • Hair and scalp devices claimed to eliminate baldness or remove unwanted hair painlessly and permanently.
• Youth prolongers claimed to eliminate wrinkles and restore youthful facial contours.
• Air purifiers claimed to destroy bacteria and tuberculosis germs and reduce the aging process.
• Disease diagnosers claimed to be capable of diagnosing all diseases or a wide variety of diseases.
• Cure-all devices claimed to be effective for diagnosing or treating a wide variety of illnesses.
The “Signs of a Quack Device” Consumer Tip box indicates what should arouse suspicion. The Historical Perspective box provides a brief account of quack de- vices used many years ago.
Investigate Carefully • If you have reason to be concerned about the safety
of your water supply, obtain an independent opinion. Ask the local water authority for the latest test of your community’s water supply. If you have your own supply, ask the local or state health department whether free testing is available; most will test for bacterial contents. Private state-certified laboratories are also available.
• If a problem is found, carefully decide what you need. There are many water purifiers, ranging from simple filter devices for a kitchen faucet to expensive sophisticated systems. No device can solve every problem. Ask the testing firm or a local government official what system would be best for your problem. Then comparison shop.
• Avoid “free” home water tests. Home testing cannot provide the in-depth analysis required to determine whether water actually needs treatment or what method would be best. Home testing for acidity/ alkalinity, iron, manganese, or color is pointless because these rarely reach harmful levels.
• Be wary of claims of government approval. The government does not endorse water tests, water treatment, or purification systems. An EPA registra- tion number merely indicates the product has been registered with the EPA.
√ Consumer Tip
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Magnetic Products Many magnetic products are being marketed with claims that they are effective against pain and a wide variety of medical problems. Pulsed electromagnetic field therapy—which induces measurable electric fields—has been demonstrated effective for treating slow-healing fractures and has shown promise for a few other condi- tions. However, few studies have been published on the effect on pain of small, static magnets marketed to consumers. Explanations that magnetic fields “increase circulation,” “reduce inflammation,” or “speed recovery from injuries” are simplistic and are not supported by the weight of experimental evidence. The claims that magnets relieve pain are based primarily on testimonials from athletes. The marketing was given impetus by a study comparing the effects of magnets and sham magnets on the knee pain of 50 adult patients who had had poliomyelitis during child- hood. The 29 who received an active magnet reported a significantly greater reduction in pain than the 21 treated with a sham magnet.46 However, this finding was based on completion of a questionnaire following
a single 45-minute exposure, with no follow-up study to determine whether any alleged effect persisted. No published study of other painful conditions has found any benefit. Some products are too weak to provide a magnetic field that penetrates the skin or are complete fakes that exert no magnetic force whatsoever. In 1998, Magne- therapy, Inc., of West Palm Beach, Florida, agreed to pay the state of Texas $30,000 and to stop claiming that wearing its magnetic device near areas of pain and inflammation will relieve pain due to arthritis, migraine headaches, sciatica, or heel spurs. The company had provided retailers with display packages that included testimonials and posters of sports stars.47 In 1999, the FTC obtained a consent agreement barring Magnetic Therapeutic Technologies, of Irving, Texas, from claim- ing that its magnetic sleep pads or other products (a) are effective against cancers, diabetic ulcers, arthritis, degenerative joint conditions, or high blood pressure; (b) could stabilize or increase the T-cell count of HIV patients; (c) could reduce muscle spasms in persons with multiple sclerosis; (d) could increase bone density, im- munity, or circulation; or (e) are comparable or superior to prescription pain medicine. In 1999, in another FTC case, Pain Stops Here! Inc., of Baiting Hollow, N.Y., agreed to stop claiming that its “magnetized water” or other products were useful against cancer and many other diseases and could stimulate the growth of plants.47 In 2000, Florsheim, Inc., advertised on its Web site that the magnetic insoles in its MagneForce shoes “gen- erate a deep-penetrating magnetic field which increases circulation; reduces foot, leg and back fatigue; provides natural pain relief and improved energy level.” The site also claimed that some people might suffer from “magnetic deficiency.” After the Quackwatch Web site48 posted an analysis of these claims, the Consumer Justice Center, of Laguna Niguel, California, sued Florsheim for false advertising. The offending claims quickly vanished from Florsheim’s site.
Detoxification Devices Two types of quack detoxification devices are widely promoted: ionic cleansing devices and detox foot pads. During ionic cleansing sessions, the customer’s feet are bathed in a container in which salt water is subjected to a low-voltage current. During the process, the water typically turns reddish brown. Proponents claim that the process draws toxins from the body and that the color is due to the toxins entering the water. However, investiga- tions have revealed that the color change is the result of precipitation of rust (oxidized iron) created by corrosion
Signs of a Quack Device45
How can you tell whether a medical device will live up to the claims made for it? The late Bob McCoy, who operated the Museum of Questionable Medical Devices, gave these tips. You should be suspicious if:
• It is said to use little-known energies that are unde- tectable by ordinary scientists.
• It can diagnose or cure people living miles away. • It has a convoluted yet scientific-sounding name. • It was invented by a “world famous” doctor who is not actually well known.
• It has bright lights that serve no apparent purpose. • It has knobs and dials that serve no practical purpose. • It shakes, rattles, rolls, sucks, shocks, or warms your body.
• It supposedly can cure just about anything. • It is available only through the mail or at special
outlets. • You can’t find one at a regular doctor’s office. • The manufacturer isn’t exactly sure how or why it works.
• To get results, the patient must face a certain direction or use the device only at unusual times.
• You’re supposed to use it even if there’s nothing wrong with you.
• The FDA has outlawed it.
√ Consumer Tip
Chapter Twenty Health Devices 433
Elisha Perkins, a practicing physician from Connecticut, announced the invention of his Perkins Metallic Tractors in 1796. These were two rods of brass and iron about 3 inches long, rounded at one end and pointed at the other. At that time, electricity was considered a powerful force despite little knowledge of its properties. Having observed during surgery that muscles may contract when touched by a metallic instrument, Perkins concluded that metallic substances influenced nerves and muscles. He announced that his tractors could draw diseases from the body and could help against inflammation; rheumatism; and pains in the head, face, and breast. Although the state medical society expressed skepticism, the chief justice of the Supreme Court bought a pair and President Washington was a customer and wrote letters recommending the treatment. In 1799, after spending several weeks combating a yellow fever outbreak in New York City, Perkins caught the disease and died. His son Benjamin continued selling the device in England until a physician discovered that rubbing patients with wooden rods was equally effective and concluded that the curative agent was the patient’s imagination.49 Dr. Albert Abrams became professor of pathology at Cooper Medical College in San Francisco and in 1889 was appointed vice president of the California State Medical Society. His 1910 book, Spondylotherapy, theorized that the reflex center in the spinal cord could be stimulated by rapid percussion (tapping). He said that every disease had a vibratory rate and could be diagnosed by tapping the spine and abdomen to discover the patient’s disease frequency. He claimed he could determine the severity and exact location of any ailment. Abrams also claimed he could determine a person’s age, sex, and even religion from a drop of blood and could diagnose ailments from a handwriting sample. Later he introduced the reflexophone and said he could diagnose a person’s condition by telephone. Another of his devices was the oscilloclast, a sealed box with a rheostat, condenser, ohmmeter, and various wires. He claimed that the device would cure by sending into the body electrical waves that duplicated the rate of disease vibrations. Actually it was a galvanometer that reflected the amount of perspira- tion on the patient’s skin. Traveling around the country, Abrams taught courses that enabled several thousand chi- ropractors, naturopaths, and others to become “electronic practitioners.”50 A blue-ribbon committee created by Scientific Ameri- can magazine investigated Abrams and concluded that his methods were “at best an illusion, at worst a colossal fraud.” When he died in 1924, Abrams left several million dollars to his Electronic Medical Foundation to perpetuate the devices. Some continued to be used into the 1980s. Dr. Ruth B. Drown, a chiropractor, developed and sold similar instruments and conducted business with her
daughter in the Los Angeles area for about 40 years.51 One patient was a woman with a lump in her breast whose doctor had advised her to go to a hospital for treatment. Instead she visited Drown, who “diagnosed” her condition by placing a drop of her blood on a blotter, which was then inserted into a small black box as Drown ran a finger across a rubber plate. The woman was informed that she did not have cancer but a fungus had spread through her digestive system and liver. Drown also concluded that the woman had gallstones, a non-functioning kidney, and a deficiency of hydrochloric acid. The victim was told that her conditions could be cured if she would visit a practitioner near her home in Chicago. Despite treatment by this practitioner and further reassur- ance from Drown, the woman died of breast cancer. In 1949 Drown demonstrated her machine to scientists at the University of Chicago. Blood was drawn from 10 patients whose health status had been medically determined. Drown provided diagnoses for three of them. She said the first had cancer of the left breast that had spread to the ovaries and pancreas; actually the patient had tuberculosis of the right lung. Drown said that the second patient had an improperly functioning uterus, but the actual condition was high blood pressure. The third patient, said by Drown to have prostate cancer, was a healthy young physician on the hospital staff. Drown was brought to trial in 1950. Her device was shown to be a simple electrical circuit with a variety of wires. The galvanic instrument generated small voltages that registered on a dial. However, the values were apparently irrelevant to treatment, and the dried blood on the blotter was not linked to the galvanic circuit. Yet 19 patients testified to marvelous benefits from her therapy. Drown was found guilty, fined $1000, and given a 1-year suspended sentence with 5 years’ probation. The case cost $50,000 to prosecute. Drown stopped distributing her devices in interstate commerce but continued to practice in California, eventu- ally treating a total of 35,000 individuals. In 1963 she was indicted for grand theft. As part of the investigation, an undercover agent from the district attorney’s office submit- ted samples of blood that were supposedly from her three children but actually came from a healthy turkey. The reports diagnosed chickenpox and mumps, and the agent was told how to use a Drown-supplied device to treat these condi- tions. Drown died at age 74 while awaiting trial. Although Abrams’s devices are no longer marketed, dozens of similar ones have taken their place. Some have their galvanometers connected to dials that provide a numer- ical readout; others are computerized. Used by thousands of chiropractors, homeopaths, naturopaths, acupuncturists, bogus nutrition counselors, and “holistic” physicians and dentists, the devices are variously claimed to detect al- lergies, vitamin deficiencies, “imbalances in the flow of electromagnetic energy,” and other alleged dysfunctions of bodily organs. Chapters 8 and 16 describe these further.
Electrical Fakery
Historical Perspective
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of the device’s electrodes and that the water would change color whether or not a foot was placed in it.52 Various adhesive pads and patches are claimed to detoxify the body when users apply them to the soles of the feet and leave them on overnight. By morning, their proponents claim, the pads will absorb toxins and turn muddy brown or black. However, investigators have found that the darkening had nothing to do with toxins; the pads contain a chemical that reacts to moisture by becoming darker.53 In 2010 the FTC obtained an injunc- tion barring the marketers of Kinoki Detox Foot Pads from making unsubstantiated claims that their products could remove toxins, metabolic wastes, heavy metals, and other unwanted chemicals from the body.54
Negative Ion Generators Ions are atoms or groups of atoms bearing electrical charges. Positive ions lack one or more electrons; nega- tive ones possess a surplus of electrons. Polluted air may be lower in negative ions and higher in positive ions. Weather conditions can also affect ion concentrations. According to folklore, an excess of positive ions can cause a variety of physical and emotional problems. Proponents of negative ion therapy (aeroionothera- py) claim that illness can be prevented by neutralizing positive ions with negative ones produced by small generators. But negative ion generators cannot actually produce enough ions to change the air in a room effec- tively. Ions have a short half-life; their energy dissipates rapidly as they leave the generators. Scientific studies carried out during the past 20 years have failed to sup- port the claims of negative ion proponents. Moreover, the generators may produce toxic amounts of ozone.55
Alleged Performance-Enhancing Products Many companies have been selling bracelets, wrist- bands, pendants, and other items claimed to enhance performance by influencing the body’s “energy balance,” or “ionic balance.” The brand names include Power Balance, Power Band, iRenew, cPrime, Phiten, Q-Ray, and Q-Link. Professional athletes have promoted some of these products. Power Balance offers wristbands and pocket cards said to contain an embedded Mylar hologram said to contain special frequencies designed to restore the body’s energy balance, thereby increasing strength, flexibility, and balance. The device is promoted through trickery, such as muscle tests in which the pro- moter pushes against the subject in different ways before and after the product is used.56 However, a controlled trial of college athletes sponsored by the American Council on Exercise found no benefit.57
In this study, each athlete completed two trials each of trunk flexibility, balance, strength, and vertical jump. For one trial, the subjects wore a $30 Power Balance bracelet, and for the other they wore a 30-cent placebo rubber bracelet. The order of bracelets worn was com- pletely randomized and double-blinded so that neither the subjects nor the examiners knew which bracelet was being worn for which trial. The subjects did better in the second trial than the first, but the data showed no significant difference in flexibility, balance, strength, or vertical-jump height between the Power Balance and pla- cebo trials. The researchers attributed the improvements in the second trial to the “order effect” that occurred because the subjects were either more warmed up or were habituated to the tasks. The report stated that the sales demonstrations were essentially “carnival tricks,” such as pushing in a certain direction and then slightly changing the angle of pull or push to cause people to lose their balance easily. In 2010, when challenged by the the Australia Com- petition and Consumer Commission, Power Balance Pty Australia Ltd. admitted that there was no credible scientific basis for the claims and therefore no reasonable grounds for making representations about its wristbands being beneficial. The company also agreed to stop mak- ing unsubstantiated claims, offer refunds to dissatisfied customers, and publish corrective statements on its Web site and in 20 magazines.58 The resultant negative pub- licity caused sales to drop so sharply that the company filed for bankruptcy a few months later. Q-Ray bracelets were originally claimed to relieve pain. In 2008, the Federal Trade Commission obtained a court order banning such claims and ordering the market- ers to issue up to $87 million in refunds to consumers who had bought the products.59 Today the Q-Ray prod- ucts are claimed to “work to balance your own negative and positive energy forces, optimizing your Bio-Energy.”
EMF Protectors Many people are marketing low–magnetic-field electric blankets, clocks, and computer terminals for “electrically hypersensitive” people; measuring devices; and various “protective” devices said to shield against electromag- netic fields. For example, an ad for a $39.95 Cell Censor Cellular Phone/EMF Detection Meter has stated:
Learn to detect and measure: cellular phone RF radiation, electromagnetic fields generated by power lines, computer monitors, TVs, appliances, home wiring, and other unsus- pected sources. . . . It lets you instantly measure the levels in your environment, and helps you make informed purchasing decisions regarding appliances.
Chapter Twenty Health Devices 435
Contrary to what the ad implies, there is no scientific evidence that proximity to electric power lines,60 electric appliances, or cell phones61 causes any health problem or that “electrical hypersensitivity” exists.62 A National Research Council committee thoroughly evaluated pub- lished studies related to electric and magnetic fields and found no evidence of a human-health hazard.63
Ear Candles “Ear candling,” also known as coning, refers to various procedures that involve placing a cone-shaped device in the ear canal and supposedly extracting earwax and other impurities with the help of smoke or a burning wick. The procedures supposedly create a low-level vacuum that draws wax and other debris out of the ear canal. Some proponents even claim that impurities are removed from the inner ear, the facial sinuses, or the brain itself. Since wax is sticky, the negative pressure needed to pull wax from the canal would have to be so powerful that it would rupture the eardrum in the process.64 However, research- ers who measured the effect of candling on ear models demonstrated that it creates no negative pressure within the ear canal. The same investigators candled eight ears and found that no ear wax was removed and candle wax was actually deposited in some of them. Candling poses several dangers, the most serious of which involve burn- ing caused by the hot wax.65
consuMer strategY
When considering the purchase of a device, it is wise to consider such things as personal health status; ease of set-up; instructions for use; training requirements; convenience of use; initial cost; maintenance require- ments and cost; safety features and precautions (e.g., risk to children or pets); and where to get help if problems develop. Should any serious injuries or close calls occur, they should be reported to the FDA (800-332-1088) as well as to the product’s manufacturer and/or supplier.
suMMarY
Medical devices include several thousand types of health products, from simple articles to complex medi- cal equipment. Federal laws define “medical device” as any health-care product that does not achieve any of its principal intended purposes by chemical action in or on the body or by being metabolized. The general quality of professionally used medical devices is high, but FDA regulation needs strengthening.
Devices commonly used by consumers include eyeglasses, contact lenses, and hearing aids. Purchase of these products should be preceded by a thorough professional examination. Since prices vary considerably, comparison shopping is also wise. Some devices have been marketed with misleading claims. Some hearing aid manufacturers and salespeople have exaggerated what hearing aids can do. Scare tac- tics are often used to sell water-treatment devices that are unnecessary or overpriced. Quack devices are still a significant problem.
reFerences
1. Hearing aid claims—Just a lot of noise? AARP Senior Consumer Alert, Spring 1995.
2. Is the product a medical device? FDA Web site, March 1, 2010. 3. Jaggi G, Giovannetti G, editors. Pulse of the industry: Medical
technology report 2010. Boston, 2010, Ernst & Young Global Life Sciences Center.
4. Kessler DA and others. The federal regulation of medical devices. New England Journal of Medicine 317:357–366, 1987.
5. GAO finds FDA drags feet in medical device safety. Public Citizen Health Research Group Health Letter 5(6):10–11, 1989.
6. Shapiro JK. What happens to medical device reports once they reach FDA? MDDI Medical Device and Diagnostic Industry News and Suppliers Web site, Dec 22, 2010.
7. Medical devices: FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process. Government Accountability Office Report GAO- 09-190, Jan 2009.
8. Zuckerman DM and others. Medical device recalls and the FDA approval process. Archives of Internal Medicine 171:1006–1011, 2011.
9. Mosenkis R. Human factors design—Do’s and don’ts. Medical Design & Diagnostics Industry 12(9):58–61, 1990, plus inter- view in April 2011 by Dr. Stephen Barrett.
10. Friedlander MH, Donev S. 20/20: A Total Guide to Improving Your Vision and Preventing Eye Disease. New York, 1994, Wings Books.
11. Limitations of vision screening programs. American Optometric Association Web site, accessed April 18, 2011.
1. You are nearsighted and dislike wearing glasses. You have tried contact lenses and consider them a nuisance. What information should you seek to make an intelligent decision about refractive surgery?
2. Your friend appears to have difficulty hearing clearly. You have detected this problem because the person frequently asks you to repeat yourself. What should you suggest? Would a visit to a local hearing aid dealer be a suitable first step?
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12. Screening for visual impairment in children ages 1–5 years. U.S. Preventive Services Task Force Web site, April 2011.
13. Screening for impaired visual acuity in older adults. U.S. Pre- ventive Services Task Force Web site, July 2009.
14. Caprioli J and others. Comprehensive adult medical eye evalua- tion. San Francisco, 2000, American Academy of Ophthalmology.
15. Screening for glaucoma. U.S. Preventive Services Task Force Web site, March 2005.
16. Shopping for eyeglasses. Consumer Reports 75(12):16–8, 2010. 17. Sunglasses are more than shades. St. Louis, 1994, American
Optometric Association. 18. Consumer guide to sunglasses. St. Louis, 1997, American
Optometric Association. 19. Worrall RS and others. Eye-related quackery. Quackwatch Web
site, April 22, 2009. 20. Advantages and disadvantages of various types of contact lenses.
American Optometric Association Web site, accessed April 18, 2011. 21. Joint statement—Learning disabilities, dyslexia, and vision.
Pediatrics 124:837–844, 2009. 22. Taylor A and others. Relations among aging, antioxidant sta-
tus, and cataract. American Journal of Clinical Nutrition 62(6 Suppl):1439S–1447S, 1995.
23. Christen WG Jr. Antioxidants and eye disease. American Journal of Medicine 97(3A):14S–17S, 1994.
24. Cataract surgery: Beware the traps. Consumer Reports on Health 5(5):48–50, 1993.
25. New lenses reinvent cataract surgery. The Cleveland Clinic Men’s Health Letter 7(2):1,6, 2005.
26. Nijcamp ND and others. Effectiveness of multifocal intraocular lenses to correct presbyopia after cataract surgery: A randomized controlled trial. Ophthalmology 111:1832–1839, 2004.
27. Nevyas HJ, Nevyas-Wallace A. Your guide to refractive surgery. Quackwatch Web site, March 25, 2010.
28. FDA’s Lasik Eye Surgery Web site, March 9, 2005. 29. Be wary of the Lasik Vision Institute. Quackwatch Web site,
Dec 7, 2003. 30. Quick statistics. National Institute on Deafness and Other Com-
munication Disorders Web site, June 16, 2010. 31. Franks JR, Beckman NJ. Rejection of hearing aids: Attitudes
of geriatric sample. Ear and Hearing 6:161–166, 1985. 32. NIH Consensus Conference: Noise and hearing loss. JAMA
263:3185–3190, 1990. 33. Rados C. Sound advice about age-related hearing loss. FDA
Consumer 39(3):20–27, 2005. 34. Types of hearing instruments. International Hearing Society
Web site, accessed April 24, 2011. 35. Rezen SV, Hausman C. Coping with Hearing Loss: A Guide for
Adults and Their Families. New York, 1985, Dembner Books. 36. Hear well in a noisy world: Hearing aids, hearing protection,
& more. Consumer Reports 74(7):32–37, 2009. 37. Personal emergency response systems. Federal Trade Commis-
sion Web site, accessed May 19, 2011. 38. Ranta PM, Ownby DR. A review of natural-rubber latex allergy
in health care workers. Clinical Infectious Diseases 38:252–254, 2004.
39. FDA Center for Devices and Radiologic Health. User labeling for devices that contain natural rubber (21 CFR 801.437); small entity compliance guide. April 1, 2003.
40. Fit to drink: Devices that help keep water in good taste and you in good health. Consumer Reports 66(10):52–55, 1999.
41. The selling of water safety. Consumer Reports 55:27–43, 1990. 42. Bottled water: Better than tap? UC Berkeley Wellness Letter,
Nov 2005. 43. Barrrett S. Be wary of spinal decompression with VAX-D or
similar devices. Quackwatch Web site, Oct 23, 2010. 44. FDA. The big quack attack: Medical devices. HHS Publication
No. (FDA) 80-442, Washington, D.C., 1980, U.S. Government Printing Office.
45. McCoy B. Quack! Tales of Medical Fraud from the Museum of Questionable Medical Devices. Santa Monica, Calif., 2000, Santa Monica Press.
46. Vallbona C and others. Response of pain to static magnetic fields in postpolio patients: A double-blind pilot study. Archives of Physical and Rehabilitative Medicine 78:1200–1203, 1997.
47. Barrett S. Magnet therapy: A skeptical view. Quackwatch Web site, June 29, 2008.
48. Barrett S. Florsheim’s MagneForce shoes: Should we worry about “magnetic deficiency”? Quackwatch Web site, Aug 8, 2000.
49. Smith RL. The strange world of mechanical quackery. Today’s Health 42:42–47, 1964.
50. Gevitz N. Three perspectives on unorthodox medicine. In Gevitz N, editor. Other Healers: Unorthodox Medicine in America. Baltimore, 1988, Johns Hopkins University Press.
51. Smith RL. The Incredible Drown Case. Today’s Health 46:46, 1968.
52. Barrett S. The Aqua Detox scam. Device Watch Web site, Dec 28, 2004.
53. Barrett S. The detox foot pad scam. Device Watch Web site, Nov 2, 2010.
54. At FTC’s request, judge imposes ban on marketers of “detox” foot pads: Advertising claimed “ancient Japanese secret” could treat medical conditions. FTC news release, Nov 4, 2010.
55. Sampson WI. The holistic hodgepodge. In Barrett S, Jarvis WT. The Health Robbers: A Close Look at Quackery in America. Amherst, N.Y., 1993, Prometheus Books.
56. Hall HA. Power Balance products: A skeptical look. Device Watch Web site, March 26, 2011.
57. Porcari JP and others. Power Balance or power of persuasion? ACE Web site, March 2011.
58. Power Balance admits no reasonable basis for wristband claims, consumers offered refunds. ACCC press release, Dec 22, 2010.
59. Appeals court affirms ruling in FTC’s favor in Q-Ray bracelet case. FTC news release, Jan 7, 2008.
60. Farley JW. Power lines and cancer: Nothing to fear. Quackwatch Web site, Sept 24, 2000.
61. Health issues: Do cell phones pose a health hazard? FDA Web site, May 18, 2010.
62. Rubin GJ and others. Idiopathic environmental intolerance attributed to electromagnetic fields (formerly ‘electromagnetic hypersensitivity’): An updated systematic review. Bioelectro- magnetics 31:1–11, 2010.
63. National Research Council Committee on the Possible Effects of Electromagnetic Fields on Biologic Systems. Possible Health Effects of Exposure to Residential Electric and Magnetic Fields. Washington, D.C., 1997, National Academy Press.
64. Roazen L. Why ear candling is not a good idea. Quackwatch Web site, May 12, 2010.
65. Seely DR and others. Ear candles: Efficacy and safety. Laryn- goscope 106:1226–1229, 1996.
Coping with Death
It is a myth to think that death is only for the old. Death is there from the very beginning. Herman FeiFel1
Most Americans have difficulty accepting death as a normal physiological process. In the current system of care many dy- ing persons suffer needlessly, burden their families, and die isolated from family and community.
ama CounCil on SCientiFiC aFFairS2
No technology is available or even foreseeable that will make immortality possible anytime in the lives of anyone reading this, or their kids, or their kids’ kids. Live a lot longer? Maybe. Live forever? Not a chance anytime soon.
artHur l. Caplan, pHD3
Chapter Twenty-One
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• The burden of death may be eased by understanding the emotions involved and planning ahead to deal with various issues that pertain to dying.
• An advance directive can help people control what care they receive when terminally ill.
• Hospice care is worthwhile for many terminally ill individuals and their families.
• Most decisions about purchasing funeral products and services are made by people who are grieving and under time constraints. Some providers take advantage of this situation by selling services that are unnecessary or overpriced. Alternative arrangements to the traditional funeral can be dignified without being costly.
• Many products are marketed with false claims that they can help extend life or slow biologic aging.
Keep these points in MinD as You stuDY this Chapter
Key Concepts
Figure 21-1. Wallet card for advance directive. The name and address of the signer’s physician and location of the advance directive are noted on the reverse side.
Death and bereavement are inevitable aspects of human experience that present significant emotional and financial challenges. This chapter
offers information to help you make intelligent decisions about preparing an advance medical directive; viatical settlements; care of the terminally ill; euthanasia and assisted suicide; donating body parts; autopsies; body disposition arrangements; and coping with grief. It also analyzes products and services promoted for life exten- sion and “anti-aging.” Additional preparation for the inevitable should include estate planning (including a will and life insurance) and other financial matters that are beyond the scope of this textbook.
aDvanCe DireCtives
Consumer Reports on Health4 has stated that the need to prepare for death is pressing because machines often can keep a seriously ill or permanently unconscious patient alive, sometimes indefinitely, with no hope of recovery. However, people do have certain rights to refuse treat- ment. Anyone 18 years or older who wishes to invoke the right to refuse medical treatment should prepare an advance medical directive, which may be a living will, a durable power of attorney for health care (DPAHC), or a combination of the two. A living will—also called a health-care directive—is a document in which a person states whether artificial life-support procedures such as a respirator or intra- venous feeding should be used if the person becomes terminally ill (as defined by state law) or is too sick (e.g., in a coma) to communicate treatment preferences. A durable power of attorney—also known as a health- care power of attorney or health-care proxy—designates another individual (proxy), usually a family member or intimate friend, to make treatment decisions when the patient cannot.
Living wills are advantageous because they enable people to specify what they want done. However, a very specific document may not provide guidance for situa- tions that were not anticipated, and a broadly written document may not be clear about actual situations. The DPAHC enables the signer’s agent to make decisions not covered by a living will and to discuss the situation with the patient’s doctor. Its major disadvantage is that there may not be anyone with whom the signer feels comfortable as an agent. Experts advise preparing both documents and mak- ing sure that one’s family and physician are aware of them. Many states provide model forms, and a few states require their use if people wish to execute an advance directive. Forms are also available to patients in hospitals and in long-term-care facilities. Although not required, it is prudent to review one’s advance directives with an attorney and to do so far ahead of the time they are likely to be needed. The American Medical Association (AMA)5 advises that if a state form seems too restrictive, an alternative form can be followed. However, it is advisable to be sure that the form and witnessing procedure comply
Chapter Twenty-One Coping with Death 439
DECLARATION
I, ____________________________________, being of sound mind, willfully and voluntarily make this dec- laration to be followed if I become incompetent. This declaration reflects my firm and settled commitment to refuse life-sustaining treatment under the circumstances indicated below.
I direct my attending physician to withhold or withdraw life-sustaining treatment that serves only to prolong the process of my dying, if I should be in a terminal condition or in a state of permanent unconsciousness.
I direct that treatment be limited to measures to keep me comfortable and to relieve pain, including any pain that might occur by withholding or withdrawing life-sustaining treatment.
In addition, if I am in the condition described above, I feel especially strongly about the following forms of treat- ment:
I ( ) do I ( ) do not want cardiac resuscitation.
I ( ) do I ( ) do not want mechanical respiration.
I ( ) do I ( ) do not want tube feeding or any other artificial or invasive form of nutrition (food) or hydration (water).
I ( ) do I ( ) do not want blood or blood products.
I ( ) do I ( ) do not want any form of surgery or invasive diagnostic tests.
I ( ) do I ( ) do not want kidney dialysis.
I ( ) do I ( ) do not want antibiotics.
I realize that if I do not specifically indicate my preference regarding any of the forms of treatment listed above, I may receive that form of treatment.
Other instructions: _________________________________________________________________________
____________________________________________________________________________________________
I ( ) do I ( ) do not want to designate another person as my surrogate to make medical treatment decisions for me if I should be incompetent and in a terminal condition or in a state of permanent unconsciousness.
Name and address of surrogate (if applicable): _______________________________________________________________________________
Name and address of substitute surrogate (if surrogate designated above is unable to serve): ____________________________________________________
I made this declaration on the ____ day of ________, ____.
Declarant’s signature: _______________________________
Declarant’s address: _______________________________________________________________________
The declarant or the person on behalf of and at the direction of the declarant knowingly and voluntarily signed this writing by signature or mark in my presence.
Witness’ signature: ______________________________
Witness’ address:________________________________
Witness’ signature: ______________________________
Witness’ address:________________________________
Figure 21-2. Sample form for advance medical directive and living will combination.
Part Five Other Products and Services440
with state law. Figure 21-1 illustrates a wallet card for indicating where your advance directive can be located. Figure 21-2 illustrates a simply worded living will and DPAHC combination. A study of more than 9000 hospital patients found that “do not resuscitate” (DNR) orders were not written promptly, many patients still died in pain in intensive care surroundings, and most of the doctors seemed to misunderstand their patients’ wishes to forgo futile medical procedures.6 DNR orders can be written by the attending physician in accord with the wishes of the patient or—if the patient is incompetent—those of the patient’s designated surrogate or next-of-kin. (An incom- petent patient is one who is too ill to communicate or to comprehend the situation.) But the designated person may need to be watchful and assertive. In many states, doctors can get relevant patient- management forms through a POLST Paradigm program (www.ohsu.edu/polst/index.htm).
Federal Law The federal Patient Self-Determination Act (1990) applies to hospitals, nursing homes, hospices, health maintenance organizations, and home health-care agen- cies that receive Medicare or Medicaid funding. The law provides that when a person is admitted to a health facility, the medical staff must:
• Inform the individual of the facility’s policy on implement- ing advance directives.
• Provide all adults with written information about their rights under state law to accept or refuse treatment and to execute advance directives.
• Make the person’s living will or advance directive part of the person’s medical record.
• Take no discriminatory action because of any decision regarding life-sustaining medical treatment.
Guidelines for Physicians The AMA Council on Ethical and Judicial Affairs7 states that it is ethical to stop or withhold life-support treatment to let a terminally ill patient die, but that a physician should not intentionally cause death. The council also has ruled that when the duty to prolong life conflicts with the duty to relieve suffering, the physician, the patient, and/ or a surrogate decision-maker (usually a family member) have discretion to resolve the conflict. In 1988 participants in a landmark international conference proposed guidelines to help physicians deal ethically with issues related to forgoing treatment. They concluded that physicians should (a) feel morally obligated not to inflict harm or risk harming others; (b) respect patients’ choices selected according to their own conscience, values, and religious convictions; and (c) act fairly and justly in allocating scarce resources. The other guidelines included:
For patientS witH an aDvanCe DireCtive wHo beCome inCompe- tent: If the advanced directive states that the patient does not want certain treatments, the physician should not impose them even if potentially life-prolonging. Regardless of what
Dying, which was once viewed as natural and expected, has be come medicalized into an unwelcome part of medical care. It has been distorted from a natural event of great social and cultural significance into the end point of untreatable or inadequately treated dis ease or injury. Worse, death has be come medicine’s enemy—a reminder of our limitations of medical diagnosis and management. After an anticipated death from a known terminal illness, for example, medical colleagues would be ex pected to make humane efforts to help family and caregivers un- derstand this natural event and assuage their feelings of loss and sadness. Instead, the medical decisions leading up to the death may be defensively reviewed with the family, then scrutinized for mistakes by peers at clini- copathologic conferences, reported to risk management to be certain that liability issues are addressed, or critiqued in man dated quality assurance reviews. It is little wonder
Personal Glimpse
that physicians engage in inap propriately heroic battles against dying and death, even when it may be apparent to physician, patient, and family that a rapid, good death is the best outcome. Viewing dying and death as merely a failure of medi- cal diagnosis and therapy . . . trivializes the final event of our lives, stripping it of important non medical meaning for patients, family, and society. This narrow view of dying may be a particular concern for the very el derly, for whom death is an expected and sometimes desired event. Respect for the wholeness of life requires that we not debase its final stage; art, literature, and the social sciences teach us that a good death can be a natural, courageous, and thoughtful end to life. Jack D. McCue, M.D.8 © 1995 American Medical Association
The Naturalness of Dying
Chapter Twenty-One Coping with Death 441
has been stated, the physician should not be obligated to provide physiologically futile treatments.
For patientS witHout an aDvanCe DireCtive wHo beCome in- Competent: The physician: (a) should try to follow patients’ preferences as much as possible, (b) has a duty to discuss all alternatives with the family or significant others and seek an acceptable plan of action, (c) should consult with other professionals if the patient has no family or friends, and (d) need not provide futile treatment even if asked to do so.
For patientS wHo Have never been Competent: The physician: (a) does not have an absolute duty to order life-prolonging treatment; (b) should weigh benefits and burdens of treat- ment in terms of quality of life; (c) should involve family, surrogates, physicians, and other caregivers in decisions; (d) should act in a trustworthy manner; and (e) may withhold life-prolonging treatment if its burdens outweigh potential benefits.
SCarCity oF reSourCeS: (a) Society must establish limits and priorities, (b) processes used to establish limits should be open and fair, (c) established policies that are restrictive must be publicized in advance of patient admission, and (d) the patient has no right to any treatment that has no reasonable expectation of benefit.9
Drafting an Advance Directive The requirements for advance directive vary from state to state. State-specific forms and instructions can be downloaded free from the Web sites of Caring Connections (www.caringinfo.org) or Compassion & Choices (www.compassionandchoices.org). The Caring Conversations10 workbook, which can be downloaded from the Center for Practical Bioethics Web site (www. practicalbioethics.org), is a helpful step-by-step guide to planning and discussing advance directives. It is possible to complete an advance directive without legal help. However, it may still be advisable to consult an attorney to be certain that the implications of alternative choices are clearly understood. The docu- ments must be witnessed, and many states require that they be notarized. To be on the safe side, both procedures are advisable. The completed documents should be kept in an eas- ily accessible place, and photocopies should be given to everyone named in the documents and possibly one’s attorney and primary-care physician. The documents will stay in effect unless cancelled or replaced, so it is important to review them periodically.
viatiCal settleMents
Faced with the financial burden of a terminal illness, some people choose to sell their life-insurance policy for an immediate lump sum. The viatical settlement company (or a third-party investor who purchases the
policy) pays any subsequent premiums and collects the face value when death occurs. The 1996 Health Insur- ance Portability and Accountability Act permits people with a life expectancy of less than 2 years to receive the distribution tax-free. A viatical settlement company may pay 75% of the face value of a policy to a person whose life expectancy is 6 months or less. However, any such sale can hinder eligibility for Medicaid coverage. Decisions about insurance benefits can have a pro- found financial and emotional impact on dependents,
Who Should Determine When Someone Has the Right to Die?
In 1990 the U.S. Supreme Court affirmed that compe- tent people have a right to refuse life-sustaining treat- ment, including artificially given food and fluids. But when patients are incompetent, the court said, they are unable to make informed and voluntary choices. States are therefore justified in requiring “clear and convinc- ing evidence” of the patient’s wishes before allowing withdrawal of such support measures. The ruling was applied to the case of 32-year-old Nancy Cruzan, who had been in a coma as a result of irreversible brain damage since a 1983 car accident. By a 5-4 vote the Supreme Court11 upheld a Missouri Supreme Court ruling that Ms. Cruzan’s guardian could not terminate her treatment because there was not sufficient evidence of her wishes. The verdict stimulated many hospitals to become more aggressive about having patients sign a living will or other “advance directive” to be used if they become irreversibly ill and are unable to speak for themselves. The most publicized case since that time is that of Terri Schiavo, who died in 2005 after a 7-year legal struggle between her husband and her parents. In 1990, she suffered a cardiac arrest (heart stoppage) that re- sulted in severe brain damage and eventually led to a persistent vegetative state that required feeding through a tube to keep her alive. In 1998, her husband petitioned in court to remove the feeding tube, contending that Terri would not have wanted to be kept alive artificially. Her parents argued that she had no such wish and could get better with treatment that included oxygen adminis- tration and medication to increase her blood pressure. (Neither of these methods has any scientific support.) The courts concluded that she could not recover12 and permitted her feeding tube to be withdrawn. She died a few days later. The autopsy confirmed that the parts of her brain needed for awareness and vision had been irreversibly destroyed.
Personal Glimpse
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friends, and caregivers. People considering a viatical settlement should investigate carefully and consult a professional adviser.13 It is best to deal with a company that uses institutional rather than private funding. Some agents fraudulently recruit terminally ill people to apply for multiple policies.14 They misrepresent the truth and answer “no” to all of the medical questions. Healthy impostors then undergo the medical evaluation. In many cases, the insurance agent who issues the policy is a party to the scheme. The agent or one applicant may even submit the same application to many insurance companies. Viatical settlement companies then purchase the policies and sell them to unsuspecting third-party investors who may receive little or nothing in return for their “guaranteed” investment. The insurance industry is at risk for huge damages with this type of scheme.
Donations oF organs anD tissues
Transplantation is usually thought of in terms of major organs such as the heart, kidney, or lung. However, many body tissues can also be used to help the living. Corneal transplants can restore sight. Skin grafts can help burn victims. Heart valves can aid those with congenital heart disease. Ligaments can help people with athletic injuries. Bones are also suitable for grafting. Bone marrow from a live donor can be used to save certain patients with leu- kemia and several other disorders. However, this section focuses mainly on posthumous (after-death) donation. The best opportunities for organ donation occur when death results from a head injury or stroke that results in brain death. However, if death results from heart disease, donation may be limited to eyes and certain tissues. The National Transplant Act of 1984 initiated development of a national system to ensure equitable allocation. In 1986, the Department of Health and Hu- man Services contracted with the United Network for Organ Sharing (UNOS) to operate the Organ Procure- ment and Transportation Network (OPTN). Mansfield15 has noted that one deceased donor can save eight lives through organ donation and enhance up to 50 through tissue donation. OPTN maintains a patient waiting list and an organ matching system; coordinates the logistics of matching the organs; collects, analyzes, and publishes transplant data; and educates health professionals about the dona- tion process. Its centralized computer network links all organ procurement organizations and transplant centers and is accessible 24 hours a day, 7 days a week, with specialists available to answer calls. The waiting list in December 2011 had about 112,500 registrants.
When a donor becomes available, the transplant center or organ procurement organization will access the computer, which generates a list of patients ranked according to OPTN policies. The transplant coordinator then asks the transplant team to select a patient for further evaluation. The factors that affect rankings include tissue match, blood type, urgency of need, length of time on the waiting list, immune status, and distance from the available organ. The identities of the donor and recipi- ent are confidential, but some basic information may be shared. OPTN16 reported that in 2008, 21,065 organs were transplanted from deceased donors and 6216 organs were transplanted from 6991 living donors. About 96% of the living donors were kidney donors between the ages of 18 and 64. Most of the posthumous donors were killed by a motor vehicle accident, another source of head injury, or a stroke. The 5-year survival rate for transplant recipients ranged from 45% for heart-lung recipients to 91% for people who received a kidney from a living donor. Americans generally feel favorably toward organ donation, but misconceptions still influence whether people become donors. The positive factors include hu- manitarian feelings and pride experienced by the donor. The negative factors include fears of body disfigurement, religious concerns, and fears of receiving inadequate medical treatment when one’s life is at risk.17 Such fears are unfounded:
• When people are admitted to a hospital, the number one priority is to save their life. Donation has no relevance un- less death is imminent or has occurred.
• All major organized religions approve of organ and tissue donation and consider it an act of charity.
• Donated organs are removed surgically, in an operation similar to gallbladder or appendix removal. Donation does not change the appearance of the body for the funeral service.
In some parts of the world the selling of body or- gans is a commercial enterprise. In the United States, the interstate sale of body parts is a federal crime, but because the number of people awaiting body parts greatly exceeds the number of donors, proposals have been made to provide financial aid or material incentives to the heirs of posthumous donors. This might come in several ways: (a) burial expenses, (b) rebates or deferral of state and federal income taxes, (c) a fixed grant for the surviving spouse and/or dependent children, and (d) a government-sponsored or paid-for insurance policy payable to a designated beneficiary. In 2010, a bone marrow specialist, the mother of three children who needed a bone marrow transplant to save their lives,
Chapter Twenty-One Coping with Death 443
and several other plaintiffs filed a lawsuit that argued that the government should not put bone marrow in the same category as solid organs, such as kidneys, and should permit compensation to attract more donors.18 In December 2011 the 9th U.S. Circuit Court of Appeals sided with the plaintiffs, but the U.S. Attorney General may appeal this decision. How to Donate Every state has adopted some form of the Uniform Anatomical Gift Act, which recognizes the right of all Americans to have their organs and tissues donated after they die. These laws provide that when the individual’s intent is not known, the next-of-kin can make this deci- sion. The simplest way to make posthumous donation possible is to fill out an organ donor card that can be carried in one’s wallet or other easily locatable place. The decision should also be discussed with family and friends. In some states, permission to use tissues after death may be indicated on one’s driver’s license or an attached card. A Uniform Donor Card is available from UNOS and several other organizations (Figure 21-3). Identification bracelets indicating a wish to donate are available from Medic Alert Foundation. The Living Bank maintains an unofficial national registry and publishes a free newsletter. Family wishes take precedence over what the donor card indicates. However, several stud- ies suggest that both medical professionals and family members are more likely to favor what is indicated on a donor card.19
hospiCe Care
Hospice care is a way of providing support to people who are expected to live six months or less and their family members. It is provided mostly in the home by family and friends with the support of health professionals and volunteers. Beresford20 describes it as “an alternative to conventional, cure-oriented medical treatment aimed at fighting the disease by any means possible, at the time when that approach has become counterproductive.” This includes situations where continued treatment could delay death a bit longer but would have severe side effects. The modern hospice movement began in 1967 with the founding of St. Christopher’s Hospice in England.21 The first American program began in 1974 in Connecti- cut. In 2009 there were about 5000 hospices in the United States, about 63% of which were Medicare-certified. To achieve certification, a hospice must provide 24- hour availability; medical and nursing care; home care
services; access to inpatient care; social work services; medications, medical supplies, and durable medical equipment related to the illness; and physical, occupa- tional, and speech therapy as appropriate. At least 5% of the hours required must be contributed by unpaid volunteers. Most hospices in the United States are independently based community organizations (57.7%) or divisions of hospitals (21.4%) or home health agencies (19.5%). A few are divisions of hospice corporations or nursing homes.22 Most hospice programs belong to the National Hospice and Palliative Care Organization (NHPCO), a nonprofit advocacy group founded in 1978. The NHPCO estimates that in 2009, about 40% of hospice patients had cancer, 13% had unspecified debility, 12% had heart disease, 11% had dementia, and 8% had lung disease. Hospices provide palliative (symptom-relieving) care to patients and families in both home and hos- pital settings. This includes physical (personal care); psychologic (fear, anxiety, grief); social (individual and family support); and spiritual (religious) aid by a medically supervised, interdisciplinary team of profes- sionals and volunteers. Specialists in death awareness are available. Medications are generally given not to prolong life but to relieve distressing symptoms such as pain. Emotional support is also offered during the bereavement phase of care. Hospice care was originally designed to help termi- nally ill individuals (particularly cancer patients) who wished to be as pain-free and alert as possible. This has been broadened so that programs now cover general care for anyone who may be dying. The emphasis is on quality of life rather than quantity.
Figure 21-3. Uniform Organ Donor card. The back of the card states that it is a legal document under the Uniform Anatomical Gift Act or similar laws. It also asks for the donor’s date of birth, the signature of the donor and two witnesses, and the date signed.
ORGAN DONOR CARD ____________________________________________________________
Print or Type Name of Donor In the hope that I may help others, I hereby make this anatomical gift, if medically acceptable, to take effect upon my death. The words and marks below indicate my desires.
I give: (a) _______ any needed organs or parts (b) _______ only the following organs or parts
___________________________________________________________ Specify the Organ(s) or Part(s)
for the purposes of transplantation, therapy, medical research or education;
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In 1983 Medicare began offering an option to cover hospice care for physician fees, nursing care, counsel- ing, medical social services, short-term inpatient care, medical supplies, and the services of home health aides and homemakers. To qualify, the patient must (a) be medically certified as terminally ill with a life expectancy of 6 months or less and (b) sign a statement choosing hospice care instead of standard Medicare. A Medicare beneficiary may elect to receive hospice care for two 90-day periods, followed by a 30-day period, and, when necessary, an extension period of indefinite duration. In 2005 the daily Medicare rates were about $122 for routine home care and $543 for general inpa- tient care. More than 90% of hospice-care hours are provided in the patient’s home, thus substituting for more expensive multiple hospitalizations. In 2003 the average length of enrollment for patients admitted to hospice care was 55 days and the median length of service was 22 days. Locating and Selecting a Hospice The names and addresses of hospice care organizations and agencies may be obtained from NHPCO (www. nhpco.org, 800 658-8898); the National Cancer Institute (800 4-CANCER); a discharge planner, community relations person, or social worker at a local hospital; or a local religious institution, health department, social service office, bureau of aging, or American Cancer Society office. The following questions may be useful:
About the Program • Does the hospice mainly involve home or inpatient in- stitutional care? How does it arrange for hospital care if necessary?
• Does the program serve nursing home residents? • Is the hospice Medicare/Medicaid certified? • What kind of accreditation does the hospice have? • Does the program adhere to National Hospice Organization standards?
• Are any nurses certified in hospice care?
About Services • What nurses, doctors, volunteers, or others will provide services? What services will they provide?
• What will the physician’s role be, and will the hospice be communicating with the physician?
• What services will be available 24 hours a day? • Will someone help with the insurance forms? • How often will the nurse, doctor, or other staff member visit the home or provide services?
• How are middle-of-the-night crises handled? • What follow-up services are provided if the patient must return to the hospital?
• Will bereavement counseling be available after the patient dies?
About Costs • What are the fees? Are they charged by the hour, day, or visit?
• Will the hospice accept payments by private insurance, Medicare, or other payee? Will there be additional charges not covered by these providers?
• Will the hospice handle billing with Medicare or a private insurance carrier? Will the hospice negotiate with the insur- ance carrier should charges be denied?
Other organizations that can provide information are the National Association for Home Care and Hospice and the Joint Commission on Accreditation of Healthcare Organizations.
euthanasia anD assisteD suiCiDe
This section does not address the philosophical or moral issues involved in actions taken to induce death to re- lieve suffering. Rather, it presents information about the nature of these actions, related laws, and physician responsibilities. Euthanasia is derived from a combination of Greek words that mean “a good death.” The term is used to describe situations in which a compassionate decision is made to terminate a person’s life by applying a lethal treatment (active, or direct, euthanasia) or by with- holding life-sustaining treatment (passive, or indirect, euthanasia). If the patient asks for and gives competent consent to euthanasia, the euthanasia is called voluntary. If the patient cannot give consent or has not issued an advance directive, the euthanasia is called nonvoluntary. If ac- tion were taken against the will of a patient, it would be termed involuntary and would be illegal. Voluntary active euthanasia is legal in the Northern Territory, Australia, and is government-sanctioned in The Netherlands, where physicians can administer a drug to someone who is suf- fering from an incurable disease or condition. However, it is illegal in the United States. Many hospitals have an ethics committee to help hospital staff members deal with ethical issues related to patient care. Its activities include education of staff members; formulation of hospital policies, particularly about death and dying; and advising providers and pos- sibly families. Garrett and others23 have stressed that ethics committee opinions are most valuable if they reflect independent judgments rather than those of the institution or its dominant figures. In assisted suicide, lethal doses of drugs are given or prescribed to suffering patients who intend to end their lives. This practice is illegal in almost all states.
Chapter Twenty-One Coping with Death 445
Derek Humphrey, president of the Euthanasia Research and Guidance Organization (ERGO), states that, “As- sistance in suicide should be voluntary, legal and rare and arranged by a team of health professionals, not one acting alone and covertly as now.”24 However, the AMA thinks it should remain illegal.25 In 1994 voters in Oregon narrowly passed a state law allowing physicians to prescribe lethal drugs to adults who are mentally competent and who request the drugs so that they can self-administer them. From 1998, when the law went into effect, to January 7, 2011, 525 patients took lethal medications prescribed to them under the law.26 In 2008, voters in Washington approved a similar measure by a 58% to 42% margin.
Infant Euthanasia With dramatic advances in the technology available in neonatal intensive care units (NICUs), survival of premature and congenitally deformed newborns has dra- matically improved since the early 1960s. NICUs have enabled many such infants to survive and live a produc- tive life. But some infants have such serious defects that, even with the best medical and surgical treatment, there is no hope for significant development and expensive NICU treatment can only prolong their suffering. Decisions about the appropriate way to care for hopelessly imperiled infants can be complicated. Physi- cians and hospital ethics committees may provide help- ful input. The courts generally recognize that parents have the primary responsibility for deciding whether to withhold or withdraw care. However, in 1992 the Florida Supreme Court upheld a lower court ruling that prevented an anencephalic infant from being declared dead so her organs could be used for transplants as requested by her parents. In 1994 the U.S. Supreme Court turned down an ap- peal by a Virginia hospital to discontinue life-sustaining treatment after 2 years for “Baby K,” an anencephalic infant. Anencephaly is a rare neural tube defect in which all or part of the brain is absent, thereby precluding the possibility of consciousness or feelings.27 Most anen- cephalic infants survive no more than a few days. Baby K’s anencephaly had been diagnosed during pregnancy, but the mother completed the pregnancy and asked for maximal care for the infant, who was placed on a respirator. The hospital ethics committee was unable to convince the mother that such care was futile. A district court ruled that the hospital was obligated to provide full medical care under both the federal Emergency Medical Treatment and Labor Act and the Federal Rehabilitation Act of 1973. By 1994 the total cost to the state of Virginia exceeded $800,000.28 Baby K died in 1995.
reasons For an autopsY
When there is a sudden, violent, or unexpected death, the coroner or medical examiner may be called to inves- tigate. A coroner is an elected official who may have no medical background or training. A medical examiner is an appointed public official who is a qualified physician, generally with special training in forensic medicine. If it appears that foul play is involved, the coroner or medical examiner will order an autopsy. An autopsy is a comprehensive postmortem exami- nation done for the purpose of determining the cause of death. Unless ordered by a government official, consent of the next-of-kin is required. The county or state pays for autopsies requested by the coroner or medical examiner. If a hospital physician requests the autopsy, the hospital is legally obliged to bear the cost. If the next-of-kin makes the request, that person would be responsible for the cost. Such a request might be made if the cause of death is uncertain or if medical malpractice, a hereditary disease, or a serious contagious disease is suspected but not confirmed.
BoDY Disposition
When someone dies, the bereaved must consider two things: disposal of the body and a ceremony acknowledg- ing the person’s death. Funerals and memorial services provide opportunities for expressing and validating grief, celebrating the life of the deceased, reaffirming religious or community ties, and expressing sympathy for the bereaved. The body of the deceased is present at a funeral, but not at a memorial service. Death certificates state the cause of death and are necessary to settle the financial affairs of the deceased. The business that provides help to bereaved persons is called a mortuary or funeral home. Morticians (fu- neral directors) can arrange funerals, notify friends and relatives, obtain permits and death certificates, handle arrangements for the body, place obituary and funeral notices in the newspaper, assist with cremation and cem- etery arrangements, provide transportation to and from the funeral, and attend to various other details. Some also provide a modest amount of counseling. Nearly all states license funeral directors, and all states license embalmers. (Embalming replaces the blood and other body fluids with disinfecting chemicals that retard the decomposition of the corpse.) Funeral director training includes courses in anatomy, microbiology, pathology, communicable diseases, business practices, and the psy- chology of grief. There are about 20,000 funeral homes in the United States.29
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In 2009, the average cost of a traditional funeral, including a casket and vault, was $7755, but “extras” like flowers, obituary notices, acknowledgment cards, limousines, and an unusually expensive casket can add thousands of dollars.29. This figure does not include the cost of a cemetery plot or opening, closing, or perpetually caring for the grave. However, alternative arrangements to the traditional funeral can be dignified without being costly. Funerals are much more expensive than simple burial, cremation, or cremation plus a separate memo- rial service. Big national funeral home chains tend to charge more than independent funeral homes or small local chains.
Methods Three general options for body disposal are available: burial, cremation, and donation. The corpse can be buried below ground in a grave or above ground in a mauso- leum. Direct burial, usually within 1 day, is the least expensive burial option—especially if an inexpensive casket is used—because mortuary services are minimal and refrigeration and/or embalming are not needed to preserve the body. The casket is frequently the most expensive funeral item, but prices vary widely. Caskets are usually made of metal or wood, although some are constructed of fiberglass or plastic. Most metal caskets are made from rolled steel; the lower the gauge, the thicker the steel. Wooden caskets come in hardwood, softwood, and plywood. Some metallic caskets have a rubber gasket or other feature that delays the penetration of water and retards rust formation. Some also come with a warranty for durability. Protective features add to their cost. Wooden caskets are usually not gasketed and do not carry a warranty for durability. However, both types are usually warranted for workmanship and materials. Burial requires a cemetery plot and involves the cost of opening and closing the grave, a grave marker, and cemetery upkeep. For below-ground burials, cemeteries typically require that the casket be placed in a grave liner or burial vault to prevent the ground above the casket from caving in. A grave liner, also called a “rough box,” is made of reinforced concrete and lowered into the grave before burial. A burial vault, which is more substantial and expensive than a grave liner, is typically sold for its visual appeal and is usually gasketed. Most vaults are constructed of steel-reinforced concrete and lined with other materials, including plastic. Like some caskets, the vault may be sold with a warranty of protective strength. Cremation reduces the corpse to coarse, sandlike pieces of bone by heating it at 2000°F to 2500°F for a few
hours. The remains can be kept at home (typically in an urn) or scattered at sea or over land in accordance with state and local laws. There are added costs if the remains are buried in a cemetery plot or placed in a columbarium (an above-ground vault containing niches into which urns are placed). The Cremation Association of North America states that in 2008 there were 2121 crematories and 881,661 cremations in the United States and that 36% of the 2.45 million people who died were cremated. The National Association of Funeral Directors30 predicts that this percentage will rise to 46% by 2015 and 59% by 2025. Some religions forbid the practice. In many situations it will be practical to purchase a casket from a local discounter or through the Internet. The FTC requires funeral directors to accept caskets purchased from outsiders. Consumers may also be able to negotiate with the funeral director for a discounted casket price. The least expensive caskets are made of unfinished wood, pressboard, cardboard, or canvas. The spouse or dependent children under 18 of some- one whose work was covered by Social Security are entitled to a $255 payment for funeral expenses. Some veterans are entitled to free burial at a national cemetery and a grave marker at any cemetery. The least-expensive method of body disposal is donation to a medical school that, when notified, will provide free pick-up and eventual cremation. However, the donation must be arranged before death occurs, and some schools do not have a shortage of bodies.
Memorial Societies Memorial societies—also called funeral consumer al- liances—are independent nonprofit cooperatives that provide consumer education and information about the funeral industry and alternatives to traditional funerals. There are more than 100 such local and regional groups in the United States with a combined total of approxi- mately 400,000 members. Consumers can join one by paying a small one-time fee. Many memorial societies have arranged with one or more local funeral directors to provide members with a simple dignified burial or cremation at a cost much lower than normally offered to mortuary clients. Some groups will also refer nonmembers for discounted services. The Funeral Consumers Alliance (FCA) serves as an umbrella organization for the memorial society network. Its Web site (www.funerals.org) provides extensive information and advice on all aspects of funerals. The FCA31 has issued a position statement on how to avoid the pitfalls common to prepaid funerals. However, in a telephone interview, the FCA’s executive director told Dr. Stephen Barrett that prepayment plans are extremely
Chapter Twenty-One Coping with Death 447
risky and rarely are a good investment. He also said that the “average cost” figures publicized by the funeral industry were deliberately inflated so that people will conclude that expensive funerals are the norm. Con- sumer Reports32 strongly advises consumers to stay away from prepaid plans altogether. Instead, it suggests that advanced planners merely leave an easily accessible letter of instruction that can help one’s survivors make suitable arrangements.
FTC Funeral Rule The FTC Funeral Rule, which went into effect in 1984 and was revised in 1994, bans several types of deceptive practices.33 The rule is intended to help people select what they want and to pay only for what they select. It requires providers to disclose prices and give truthful and complete information in person or, if requested, by tele- phone. The General Price List should include the cost of direct cremation; immediate burial; basic services (over- head); transfer of remains to funeral home; forwarding or receiving the remains; embalming and other preparation; use of facilities or staff for viewing or a ceremony; use of staff or equipment for a graveside service; a hearse or limousine; and caskets, liners, and vaults. Providers must also (a) truthfully disclose whether state law requires embalming, (b) state that a casket is not required for direct cremation, (c) make an unfinished wood box or alternative container available for crema- tion, and (d) provide a Statement of Funeral Goods and Services listing the prices of individual items as well as the total price. The rule prohibits (a) charging a “handling fee” for receiving a casket or other goods or (b) stating that embalming, a specially sealed casket, or any other item or service can indefinitely preserve the body of the deceased in the grave. The rule does not cover pre-need funding or direct sales by cemeteries.
Consumer Problems Most decisions about purchasing funeral goods and services are made by people when they are grieving and under time constraints. Most customers will not engage in comparison shopping, and many are vulner- able to sales pressure. Former funeral director Gregory W. Young34 stated that “the biggest moneymaker for the funeral director is consumer ignorance.” His book The High Cost of Dying describes three main types of deceptive practices:
SubStitution oF merCHanDiSe: The casket or burial vault used is a less-expensive model than the one for which the con- sumer is charged, or floral arrangements contain fewer or less expensive flowers than were promised.
CHarging For ServiCeS not neeDeD: The prime example is em- balming, which is seldom needed unless there is a viewing of the body. It is never needed if the casket is kept closed or the body is directly cremated.
Subtle perSuaSion: Some funeral directors try to mobilize guilt to induce the family to order a more expensive casket and a higher-priced funeral. This can be done with phrases like, “You have only one chance to do it right for Mom,” or claims that a higher-priced casket will last longer.
In 1996, the FTC launched the Funeral Rule Of- fenders Program (“FROP”) to boost compliance with its Funeral Rule. Under the program, funeral homes that fail to give test shoppers the itemized price lists required by the rule can enter the FROP program rather than face possible formal legal action. If they choose FROP, they make a voluntary payment and enroll in a compliance program, administered by the National Funeral Directors Association (NFDA), which includes a review of price lists, training on compliance, and follow-up testing and certification. Since the FROP program began, compliance has increased but the FTC still found that 396 of more than 2400 funeral homes it visited were significantly out of compliance. In 2010, for example, it found that 35 of 126 funeral homes visited in eight states failed to provide price lists.35 The best strategy for people concerned about funeral costs is probably to join a memorial society, which will enable them to locate and use a low-cost provider if the need arises. Those wishing to make complete pre-need arrangements should carefully investigate the reputation of any provider under consideration. (The local Better Business Bureau or state consumer protection office may have information.) The contract should be revocable, refundable, and portable (usable in any state). The price should be guaranteed and the deposit placed in a revo- cable bank trust with interest payable to the purchaser or the purchaser’s estate.
Additional Sources of Help The previously mentioned Funeral Consumers Alli- ance is the best source of advice for consumers. The International Conference of Funeral Service Examining Boards, which represents licensing boards in the United States and Canada, provides information on laws and responds to consumer inquiries or complaints about fu- neral providers. The NFDA offers consumer information and operates an arbitration program. The International Cemetery, Cremation and Funeral Association (www.ic- cfa.org), which represents businesses that provide retail death-related services to consumers, offers a complaint- resolution service.
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Coping with grieF
Grief is the sadness, pain, and suffering that occur when a family member or friend is terminally ill or dies. The intensity and duration of these emotions depend on the nature of the relationship to the dying person and the emotional makeup of the grieving persons. The Mayo Clinic Health Letter36 states that adult grief predominantly involves four reactions:
1. Shock, numbness, and disbelief. Bereaved persons may appear to be holding up well even though they feel terrible.
2. Pining, yearning, and sadness. Usually numbness turns to intense feelings of separation and mental pain in the months after the death.
3. Acceptance of loss. When death occurs, complete failure to mourn is a sign that something may be wrong.
4. Resolution of grief. As the individual “lets go,” it becomes possible to reinvest in continuing life—for example, resum- ing former behavior patterns, seeking new relationships.
Loss of a loved one can cause guilt, shame, sadness, and a fear of dying. Bereaved persons must learn to cope with reality. This process involves gradual acceptance of the fact that a loved one has died, followed by gradual reinvolvement in day-to-day activities. Mourners typi- cally must cope with a feeling of emptiness related to the fact that a part of their emotional investment has been lost. When mourning is successful, the emotions are “reinvested” as the individual becomes reinvolved in activities. Many people believe that crying and other expres- sions of sadness are abnormal and a sign of emotional weakness. Displays of emotions may be painful to other people. However, expressions of grief are normal and healthy. Cassem37 has noted:
Allowing the bereaved to express feelings is essential. The most important part of this process is to avoid the maneuvers that nullify grieving. Clichés (“It’s God’s will”), self-evident but irrelevant reassurances (“After all, you’ve got three other children”), and outright exhortations to stop grieving (“Life must go on”) should be avoided.
Bereaved individuals can best deal with grief by recognizing that the sadness they feel is normal and resuming activity when they are able to do so. Friends often can help simply by acknowledging the distress of the bereaved and expressing sympathy. Mourning rituals vary from culture to culture. Physicians often see people who feel that it is wrong to feel upset. To proceed with mourning, such people may need reassurance that it is all right to grieve. An op- portunity to ventilate both positive and negative feelings
toward the ill or deceased individual may also be helpful. Antidepressant and anti-anxiety drugs are usually not appropriate for treating uncomplicated grief. The act of giving a drug to a grieving person may convey the message that grief is abnormal. Some communities have support groups for those who need help. George A. Bonnano, Ph.D.,38 a prominent researcher, believes that most people bounce back quickly from loss of a loved one and do not go through the stages that are traditionally described. He cautions that people who do not seem upset may be resilient rather than in a state of denial.
Normal vs Pathological Grief The length of the grieving or mourning process varies among individuals. Most people take 6 to 12 months to recover, but many take less and some take considerably more. The “success” of the grieving process should not be measured by a predetermined timetable but by the griever’s acceptance of the loss. The signs of unresolved grief include suicidal thoughts, chronic sleep difficulty, overuse of alcohol or drugs, persistent depression, fail- ure to carry out normal daily routines, and persistent symptoms resembling those of the deceased. A shift to positive and realistic plans for the future is a sign that mourning is nearing completion. Professional help is unlikely to be needed unless severe depression or social isolation persists for 6 to 12 months.
liFe-extension/anti-aging QuaCKerY
The wish to delay aging and prolong life is almost uni- versal. Many entrepreneurs have capitalized on these wishes and proposed modern equivalents of the “fountain of youth.” Chapter 18 describes how cosmetics manu- facturers have made unproven claims that their products can rejuvenate the skin and/or remove wrinkles. Some product lines include vitamin supplements in addition to skin creams. Other manufacturers have marketed products claimed to prevent or delay aging, boost im- munity, cure chronic disease, and/or improve memory. Some spas offer mineral water or seawater baths, mud packs, seaweed wraps, and various other services claimed to promote rejuvenation or healing. Whereas most American spas offer fitness activities, European facilities are more likely to feature “cures,” stress re- duction, and various forms of pampering. Rejuvena- tion claims are also made by physicians engaged in unfounded practices here and abroad. Fresh cell therapy, which is claimed to rejuvenate body organs, is described in Chapter 16.
Chapter Twenty-One Coping with Death 449
Anti-Aging and Life-Extension Claims The limit of the human lifespan is probably not much more than 120 years. Many dietary methods, nutritional supplements, and drugs have been claimed to delay ag- ing and/or extend life. During the early 1980s, books by Saul Kent40 and Durk Pearson and Sandy Shaw41 called considerable public attention to this matter. The books were based mainly on misinterpretations or inappropri- ate extrapolations of animal experiments.42 However, the resultant publicity inspired many manufacturers to market products claimed to influence some aspect of aging. The FDA has driven some products of this type from the marketplace, but many others are still sold. Several studies in animals have shown that cutting calories 50% to 60% can significantly increase maxi- mum lifespan. However, the restriction also retards their growth and development and thus is not suitable for humans. Moreover, severe calorie restriction would be very difficult for people to sustain. Many types of immunologic manipulation have been proposed, including the transplantation of immune cells from young animals. However, no such approach has been demonstrated safe or effective in humans. The substances claimed to slow the aging process include Gerovital H3 (GH3), human growth hormone, dehydroepiandrosterone (DHEA), melatonin, superoxide dismutase, and antioxidant nutrients. GH3 was developed by Dr. Anna Aslan, a Roma- nian physician. The Romanian National Tourist Office and a few American physicians have promoted it as an anti-aging substance—“the secret of eternal vigor and youth.” Claims have been made that GH3 can prevent or relieve a wide variety of disorders, including arthritis, arteriosclerosis, angina pectoris and other heart condi- tions, neuritis, deafness, Parkinson’s disease, depression,
senile psychosis, and impotence. It is also claimed to stimulate hair growth, restore pigmentation to gray hair, and tighten and smoothen skin. The main ingredient in GH3 is procaine, a substance used for local anesthesia. Although many uncontrolled studies describe great benefits from the use of GH3, controlled trials using procaine have failed to demonstrate any. Low blood pressure, breathing difficulty, and convulsions have been reported among users. Noting that para-aminobenzoic acid (PABA) appears in the urine of people receiving procaine injections, a few American manufacturers have been selling procaine tablets containing PABA with false claims similar to those made for GH3. The FDA has taken regulatory ac- tion against several “GH3” marketers, but other brands still are marketed. Human growth hormone has been shown to increase muscle mass and skin thickness when injected into elderly men who produce little or no hormone of their own. However, no study has demonstrated that it is safe and effective for long-term use for any such purpose. It is very expensive, and long-term use can cause joint inflammation and diabetes-like symptoms. At present, the only proven indication for human growth hormone is to treat children with short stature caused by growth- hormone deficiency. Butler43 has noted:
Although growth hormone levels decline with age, it has not been proven that trying to maintain the levels that exist in young persons is beneficial. It is conceivable that age-related hormonal changes may serve as useful markers of physiologi- cal aging. However, this has not been demonstrated experi- mentally for either humans or animals. Although hormone- replacement trials have yielded some positive results (at least in the short term), it is clear that negative side effects can also occur in the form of increased risk for cancer, cardiovascular disease, and behavior changes. It might even turn out that lower growth-hormone levels are an indicator of health. Research findings indicate that mice that overproduce growth hormones live only a short time, sug- gesting that growth-hormone deficiency itself does not cause accelerated aging, but that the opposite may be true. . . .
DHEA is a hormone that peaks around age 25 and gradually declines after that. Scientists have speculated that declining levels of this adrenal hormone play a role in aging. On the basis of animal experiments, DHEA has been claimed to cure cancer and heart disease and to delay aging. However, significant dosages in humans can cause unwanted hair growth, liver enlargement, and other adverse effects that make its use impractical. Researchers at the Mayo Clinic have concluded that DHEA and testosterone replacement do not produce
Quackery and Terminal Illness The notion that terminal patients have nothing to lose by turning to quackery is dead wrong. Most people faced with a life-threatening disease can make a reasonable psychological adjustment. . . . Those who accept their fate are in the best position to use their remaining time wisely. . . . Quacks discourage people from making the difficult adjustment by reinforcing their denial. Such people usually die unprepared because preparation for death is an admission of failure. William T. Jarvis, Ph.D.39
√ Consumer Tip
Part Five Other Products and Services450
the beneficial effects promised by “anti-aging” promot- ers. This conclusion was based on a 2-year, placebo- controlled, randomized, double-blind study involving 87 elderly men with low blood levels of DHEA and testosterone and 57 elderly women with low levels of DHEA. Administering these hormones did raise the subjects’ blood levels. However, it failed to produce any significant beneficial effects on body composition, physical performance, insulin sensitivity, or quality of life.44 An accompanying editorial expressed doubt that negative studies, such as this one, would cause marketers to stop calling DHEA the “foundation of youth.”45
Melatonin, a hormone secreted by the pineal gland, peaks during childhood and gradually declines. Experi- ments with small numbers of people have found that melatonin influences the “body clock” and may be useful against “jet lag” and as a sleep aid. However, the fact that melatonin declines with age does not mean that the body needs larger amounts. Claims that melatonin can protect against heart disease, cancer, and cataracts and may help people with AIDS, Alzheimer’s disease, asthma, and Parkinson’s disease are speculative. Antioxidant nutrients such as selenium, vitamins C and E, and butylated hydroxytoluene (BHT) are claimed to delay aging by soaking up “free radicals” that have escaped the body’s own “free radical patrols.” Although antioxidants can deactivate free radicals in the test tube, they have not been proved to do so in humans. Much research has been done to see whether antioxidant supplements can protect against heart disease, cancer, and other diseases. So far, no life-prolonging benefit has been demonstrated (see Chapter 11). Superoxide dismutase (SOD) is an enzyme whose tissue levels in various animal species appears related to their lifespan. However, SOD supplements have no effect in humans because SOD (a protein) is digested into its component amino acids and does not reach the tissues intact. Health professionals interested in “anti-aging” strategies have formed the American Association for Anti-Aging Medicine (A4M), which holds conferences and has a certifying board. An affiliated organization, the American Board of Anti-Aging Health Professionals (ABAAHP), was established in 1999 to provide “ad- vanced education, representation, and specialty recogni- tion of healthcare professionals,” including chiroprac- tors, Ph.D.s, registered nurses, podiatrists, naturopaths, and pharmacists. Eligible individuals who pass a 1-day examination are certified as an “Anti-Aging Health Pro- fessional.” The American Board of Medical Specialties
and mainstream professional groups do not recognize these credentials. In 2001 a Government Accountability Office (GAO) report46 highlighted the potential for physical and eco- nomic harm posed by 16 dietary supplements marketed as anti-aging therapies. The report also noted that 20 companies marketing the products had been targeted by law enforcement agencies and had cost consumers approximately $36 million. In 2004, several prominent researchers47 summed up the prevailing scientific viewpoint about widely promoted anti-aging strategies:
Since recorded history individuals have been, and are con- tinuing to be, victimized by promises of extended youth or increased longevity by using unproven methods that allegedly slow, stop, or reverse aging. Our language on this matter must be unambiguous: there are no lifestyle changes, surgical procedures, vitamins, antioxidants, hormones, or techniques of genetic engineering available today that have been demon- strated to influence the processes of aging. We strongly urge the general public to avoid buying or using products or other interventions from anyone claiming that they will slow, stop, or reverse aging. . . . Health and fitness can be enhanced at any age, primarily through the avoidance of behaviors (such as smoking, excessive alcohol consumption, excessive ex- posure to sun, and obesity) that accelerate the expression of age-related diseases and by the adoption of behaviors (such as exercise and a healthy diet) that take advantage of a physiology that is inherently modifiable.
“Biologic Age” Testing Some Web sites, books, and expensive health spas pur- port to be able to determine your true “biological age” by comparing various physical and lifestyle variables to statistical norms. This can differ from your chrono- logical age (time elapsed since birth) and supposedly indicates how much you have truly aged. However, there is no agreed-upon, validated standard for measuring biological age. A Wall Street Journal reporter in her mid-30s who took two Web site tests scored “age 17” at one site and “age 46” at the other.48 Butler43 has stated that those who claim to measure “biomarkers of aging” and favorably affect them are not scientifically based and should not be marketed to the unwitting public. The nonprofit Living to 100 Life Expectancy Calen- dar Web site (www. calculator.livingto100.com) has an interactive questionnaire that suggests strategies based on research findings, but sites that use tests to generate product sales are not trustworthy.
Personal Glimpse
Chapter Twenty-One Coping with Death 451
Dubious Stem Cell Treatment Stem cell therapy is certainly a promising area for re- search. Stem cells have the ability to give rise to many specialized cells in an organism. Certain types of stem cells are already used to restore blood-forming and im- mune system functions after high-dose chemotherapy for some types of cancer, and several other restorative uses have been demonstrated. The broadest potential ap- plication is the generation of cells and tissues that could be used to repair or replace damaged organs. If scientists can learn how to control stem cell conversion into new, functionally mature cells, doctors might be able to cure many diseases for which therapy is currently inadequate. However, the claims made by commercial promoters go way beyond what is likely and should be regarded with extreme skepticism. The International Society for Stem Cell Research49 warns that undifferentiated (embryonic) stem cells are likely to cause tumors and are unlikely to become the cells needed to regenerate a tissue on their own—they would first need to be coaxed to develop into specialized cell types before transplantation. Other risks include infection, tissue rejection, complications arising from the medical procedure itself, and unforeseen risks. Novella50 has noted that it may be impossible for outsiders to determine what is actually being injected into patients at the commercial clinics.
Cryonics Cryonics is the speculative practice of using cold to try to preserve the body of a dead person indefinitely. The goal is “to carry the person forward through time, for however many decades or centuries might be necessary, until the preservation process can be reversed, and the person restored to full health.”51 Proponents claim that it is possible to preserve “with reasonable fidelity” the basic biologic components of the brain and that future technology will be able to repair brain damage caused by “imperfect preservation, premortal disease, and post- mortem changes.” In 2011 there were five providers in the United States and the cost for whole-body freezing and permanent maintenance ranged from about $28,000 to $200,000. “Brain only” suspension, which is less expensive, is also available. Cryonic technology has not been demonstrated to work in laboratory animals. Even if the rest of a person’s body could be revived after hundreds of years, the brain could not. Brain cells deteriorate within minutes after death, and any still viable when freezing begins would burst during the freezing process. Cryonics might be a suitable subject for scientific research, but marketing an unproven method to the public is quackery. National
Council Against Health Fraud founder William T. Jarvis, Ph.D., calls cryonics “quackery’s last shot at you.”52
suMMarY
The burden of death may be eased by understanding the emotions involved and planning ahead to deal with various issues that pertain to dying. The need to prepare for death has become more pressing because machines often can keep a dying, permanently unconscious patient alive, sometimes indefinitely. An advance directive can help people control what care they receive if terminally ill. Hospice care provides another way to reduce suffer- ing for patients with a terminal illness. The technology and success rates of organ transplan- tation have improved greatly during recent years, but the cost is high and there is a serious shortage of available organs. The intensity and duration of grief and mourning depend on the nature of the relationship to the dying person and emotional makeup of the survivors. Most decisions about body disposition are made by people who are grieving and under time constraints, leaving them vulnerable to price-gouging and fraud. Many entrepreneurs have exploited fears and capital- ized on people’s wishes to prolong life and delay aging.
reFerenCes
1. The New York Times, July 21, 1974. 2. AMA Council on Scientific Affairs. Good care of the dying
patient. JAMA 275:474–478, 1996. 3. Caplan AL. It’s not immoral to want to be immortal: Fears of a
world of geezers who hog up all the resources are overblown. MSNBS Buying Time commentary, April 25, 2008.
4. Avoiding prolonged death. Consumer Reports on Health 2(8):1–2, 1990.
It’s Your Decision
One of your parents is in the hospital with a terminal illness from which there is no hope of recovery. How can you resolve the following questions?
• Can you have a discussion with the physician to clarify what medical interventions might be used or withheld?
• Should your parent be encouraged to prepare—or should you prepare—a living will, durable power of attorney, or other type of advance medical directive?
• Which friends or family members, if any, should participate in helping to resolve these questions?
Part Five Other Products and Services452
5. Orentlicher D and others. Advance medical directives: A guide to living wills and powers of attorney for health care. Chicago, 1992, American Medical Association.
6. The SUPPORT Investigators. A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). JAMA 274:1591–1598, 1995.
7. AMA Council on Ethical and Judicial Affairs. Code of Medical Ethics, 2004–2005 Edition. Chicago, 2004, American Medical Association.
8. McCue JD. The naturalness of dying. JAMA 273:1039–1043, 1995.
9. Stanley JM. The Appleton International Conference: Develop- ing guidelines for decisions to forgo life-prolonging medical treatment. Journal of Medical Ethics 18(Suppl):S3–S22, 2002.
10. Caring conversations. Kansas City, Mo, 2010, Center for Practical Bioethics.
11. Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990).
12. Barrett S. Judge criticizes Hammesfahr and Maxfield testimony in Schiavo case. Casewatch Web site, Dec 8, 2004.
13. A consumer’s guide to viatical settlements. North Carolina Department of Insurance, June 2002.
14. Betting on death: Insurance settlements intended to help the dying have short-changed them and fleeced many investors. Consumer Reports 66:37–39, 2001.
15. Mansfield S. Quoted in Bren L. Keeping tissue transplants safe. FDA Consumer 39(3):36, 2005.
16. OPTN/SRTR 2009 Annual Report, Table 1.13. 17. Donation & transplantation myths. OPTN Web site, accessed
Sept 19, 2011. 18. Williams CJ. Ban on bone marrow sales challenged. Los Angeles
Times, Feb 11, 2011. 19. Ford LA, Smith SW. Memorability and persuasiveness of organ
donation message strategies. American Behavioral Science 34:695–711, 1991.
20. Beresford L. The Hospice Handbook: A Complete Guide. Bos- ton, 1993, Little Brown & Co.
21. History of hospice care. National Hospice and Palliative Care Organization Web site, accessed Aug 28, 2011.
22. NHPCO facts and figures: Hospice care in America, 2010 edi- tion. Alexandria, Va., 2010, National Hospice and Palliative Care Organization.
23. Garrett TM and others. Health Care Ethics: Principles & Prob- lems, Ed 5. Upper Saddle River, N.J., 2009, Prentice Hall.
24. Statement from Euthanasia Research and Guidance Organization Web site, June 1996.
25. Gianelli DM. Association stands firm in opposition of suicide. American Medical News, July 8/15, 1996.
26. Office of Disease Prevention and Epidemiology. Thirteenth Annual Report on Oregon’s Death with Dignity Act. Oregon Department of Human Services, Jan 25, 2011.
27. In the matter of baby K. 16F3d 590 (4th Circuit, 1994). 28. Zimmerman D. Supreme Court will not allow brainless ‘Baby
Girl K’ to die. Probe 3(11):1,4, 1994.
29. Statistics. National Association of Funeral Directors Web site, accessed Sept 17, 2011.
30. Preliminary 2008 cremations, deaths, & percent of cremations to deaths projections—2015 and 2025. National Funeral Directors Association.
31. Position Statement of the Funeral Consumers Alliance Concern- ing Prepaid Funerals. Funeral Consumers Association, Oct 10, 2008.
32. Final arrangements. Consumer Reports 66(5):28–33, 2001. 33. Federal Trade Commission. Funeral industry practices; final
amended trade regulation rule. Federal Register 59:1592–1614, 1994. 34. Young GW. The High Cost of Dying: A Guide to Funeral Plan-
ning. Amherst, N.Y., 1994, Prometheus Books. 35. FTC sues two funeral homes for failing to provide price lists;
Undercover inspections in eight states find violations of FTC’s Funeral Rule. FTC news release, July 21, 2011.
36. Grief—time can be the greatest healer of all. Mayo Clinic Health Letter 8(3):3–4, 1990.
37. Cassem NH. The person confronting death. In Nicholi AM Jr, editor. New Harvard Guide to Psychiatry. Cambridge, Mass., 1988, Harvard University Press.
38. Bonnano GA. The Other Side of Sadness: What the New Science of Bereavement Tells Us about Life after Loss. New York, 2009, Basic Books.
39. Jarvis WT. How quackery harms. In Barrett S, Cassileth BR, editors. Dubious Cancer Treatment. Tampa, Fla., 1991, American Cancer Society Florida Division.
40. Kent S. The Life Extension Revolution: The Source Book for Optimum Health and Maximum Life-Span. New York, 1980, William Morrow and Company.
41. Pearson D, Shaw S. Life Extension: A Practical Scientific Ap- proach. New York, 1982, Warner Books.
42. Yetiv JZ. Popular Nutritional Practices: A Scientific Appraisal. New York, 1988, Dell Publishing.
43. Butler RN. Some notes on “anti-aging” programs. Quackwatch Web site, March 20, 2003.
44. Nair KS and others. DHEA in elderly women and DHEA or testosterone in elderly men. New England Journal of Medicine 355:1647-1659, 2006.
45. Stewart PM. Aging and fountain-of-youth hormones. New England Journal of Medicine 355:1724-1727, 2006.
46. Heinrich J. Health products for seniors: “Anti-aging” products pose potential for physical and economic harm. Washington, D.C., Sept 2001, U.S. General Accountability Office.
47. Olshansky SJ and others. Position statement on human aging. Quackwatch Web site, Aug 27, 2004.
48. Bright B. Body language. The Wall Street Journal, Oct 11, 2004. 49. Top ten things to know about stem cell treatments. A Closer
Look at Stem Cell Treatments Web site, accessed Aug 29, 2011. 50. Novella S. Selling stem cell hype. Skeptical Inquirer 35(5):34–
35, 2011. 51. What is cryonics? Alcor Life Extension Foundation Web site,
accessed Aug 30, 2011. 52. Jarvis WT. Quotation in Butler K. A Consumer’s Guide to “Al-
ternative” Medicine. Amherst, N.Y., 1992, Prometheus Books.
HealtH-Care FaCilities
Finding a hospital is not a job for the faint of heart. Katie Baer, M.P.H.1
Harvard HealtH letter
A long stay in a nursing home can consign a resident’s family to financial hardship, even poverty. But choose the wrong nursing home, and you may also consign your loved one to physical and emotional hardship.
Consumer reports2
While staff members may be well-trained professionals, and hospi- tals may be efficiently run, in the best of circumstances most people would rather be in a familiar setting, nursed by those who know and care about them.
editors of ConsuMer rePorts BooKs3
Chapter Twenty-Two
“Wake up, Mr. Marks. It’s time for your sleeping pill!”
© 1996
Part Five Other Products and Services454
• The best choice of facility depends on the type and urgency of the problem, as well as insurance coverage and other financial considerations.
• Accreditation is a positive sign, but it does not guarantee that a facility provides high-quality services.
• Hospitalized patients should keep informed about their case and assert themselves if a problem arises.
• Long-term–care facilities vary greatly in quality and should be thoroughly investigated.
Keep tHese points in Mind as You studY tHis CHapter
Key Concepts
M any types of community facilities are avail- able to help with illnesses and infirmities. Hospitals provide inpatient treatment for
acutely or seriously ill people. Nursing homes provide convalescent services as well as long-term care for the chronically ill or disabled. A myriad of home care agencies offer services ranging from help with everyday living tasks to complex medical care. Various residential arrangements offer an alternative to institutional care. The best choice of facility depends on the type and urgency of the problem as well as insurance coverage and other financial considerations. This chapter discusses the accreditation process and focuses on outpatient clinics, urgent care centers, ambulatory surgery centers, hospi- tals, nursing homes, alternative residential facilities, and home care services. It also includes information about the cost of long-term care that is not covered in health insurance policies. Other health-care financing issues are covered in Chapter 24.
aCCreditation Accreditation of a health-care facility constitutes public recognition that it meets standards set by a recognized accrediting agency. The most prominent such agency is the Joint Commission on Accreditation of Healthcare Organizations, which was created in 1951 as the Joint Commission on Accreditation of Hospitals and assumed its current name in 1987 as its scope expanded. Its pur- pose is to improve safety and quality of care by develop- ing standards and evaluating their implementation. Its board of commissioners includes the Joint Commission’s president; representatives from the American Hospital Association, American Medical Association, American College of Physicians, American College of Surgeons, and American Dental Association; an at-large nursing representative; and public members appointed by the board itself. The Joint Commission accredits hospitals; laborato- ries; and ambulatory care, behavioral health care, home
care, long-term care, and office-based surgical programs. It also certifies disease-specific and health-care staffing programs. More than 18,000 health-care organizations and programs participate in this accreditation process.4 Accreditation is voluntary, but hospitals must be accredited to maintain a recognized residency program for physicians. Hospitals can also use accreditation by the Joint Commission to qualify to receive direct pay- ment from Medicare and Medicaid without having to undergo a government survey. In most states and the District of Columbia, Joint Commission accreditation is also recognized in whole or in part for purposes of hospital licensure. The “General Public” section of the Joint Commis- sion’s Web site (www.jcaho.org) describes standards, provides detailed advice on how to choose facilities, and has a searchable directory of those that have been evaluated. The Accreditation Association for Ambulatory Health Care (AAAHC), which is discussed later in this chapter, is a private, non-profit organization that accred- its nearly 5000 facilities.
outpatient MediCal FaCilities
Outpatient medical facilities include private medical offices, student health services, work-related facilities, urgent care centers, ambulatory surgery centers, and hospital emergency departments and outpatient clinics. Table 22-1 on page 456 summarizes their advantages and disadvantages. (The word “ambulatory” refers to patients who are mobile and not confined to bed.)
Private Medical Offices The percentage of physicians who practice in groups has been gradually increasing. The 2007 National Ambula- tory Medical Care Survey5 found that 30.5% of the office visits were made to solo practitioners (down from 38.7% in 1997), 12.2% were made to offices with 2 physicians, 30.9% were made to groups with 3–5 physicians, 17.7%
Chapter Twenty-Two Health-Care Facilities 455
(www.acha.org) maintains a list of accredited college and university health services and lists standards for health promotion.7
Hospital Emergency Departments Most hospitals have an emergency department that is open 24 hours a day, 365 days a year, and is supervised by physicians experienced in emergency medicine. These facilities give priority to people who are seriously ill or injured. People with less serious problems will usually be seen but may have a lengthy wait. Emergency department care typically costs more than twice as much as similar care in a private medical office or urgent care center. However, emergency care cannot be denied because someone is uninsured or unable to pay. The Consolidated Omnibus Budget Reconcili- ation Act (COBRA), which Congress passed in 1986, requires that everyone who shows up for care be exam- ined. If the situation is an emergency (or the person is a woman in labor), the hospital must provide treatment at least until the condition has stabilized.8 Violating this law can trigger fines and loss of the hospital’s accreditation (see Historical Perspective box). Hospitals that provide comprehensive emergency services for injured patients may be designated as trauma centers by meeting state or local requirements or being verified by the American College of Surgeons.9
Hospital Outpatient Clinics Many hospitals have outpatient clinics where the fees are based on the individual’s ability to pay. In teaching hospitals much of this care is rendered by resident physi- cians. Many clinics have such a full schedule that new patients must wait months to be seen by appointment. At hospitals that receive federal funds, low-income patients who qualify under Hill-Burton Act guidelines can obtain laboratory tests and certain other services free of charge. (This legislation, which began with the Hospital Survey and Construction Act of 1946, provides federal help in constructing and modernizing hospitals and other health-care facilities.) For full-paying patients, hospital clinic fees may be higher than those at private offices.
Other Community Clinics Some communities have clinics run by the local health department or a non-profit agency. Some are open to everyone, and some serve only the poor. Some offer help for a wide variety of problems, whereas others have a narrow scope. These facilities are usually listed in the “Clinics” section of the Yellow Pages.
were made to groups with 6–10 physicians, and 8.7% were made to groups of 11 or more. The percentage of practices that employ nurse practitioners and/or physi- cian assistants has also been gradually increasing. Nearly all medical offices have scheduled hours and operate by appointment. Primary-care practitioners who know their patients well are often in the best position to render appropriate care. Chapter 5 discusses strategies for the selection and most effective use of private physi- cians.
Student Health Services At most colleges and universities, basic student health services are covered by required fees, and additional services may be covered by an insurance policy. The extent of services offered varies mainly with the size of the school. Some schools use one or more part-time physicians, whereas others maintain a full-time medical staff. At some, students seeking help are screened by a nurse or physician assistant. It is advisable for students to know the extent of their insurance coverage and what to do if an emergency arises outside of scheduled hours. The American College Health Association Web site
Doctor Fined for “Patient Dumping”6
In December 1986, an uninsured woman gave birth in an ambulance at the side of a road after being trans- ferred from a hospital emergency room by an on-call obstetrician. The doctor noted that the woman’s blood pressure was the highest he had ever seen in a pregnant woman—a condition that can lead to life-threatening complications. He ordered the woman transferred to a public hospital 170 miles away, where a sophisticated neonatal unit was available. Within an hour after the ambulance began its trip, the woman gave birth. She then returned to the original hospital and was admitted. Fortunately, both she and the baby did well. This incident led to the first case of a financial penalty against a doctor for violating a 1986 federal law intended to stop the practice known as “patient dumping.” The doctor appealed the proposed $20,000 penalty, claiming that the transfer was done to provide superior medical care and that doctors should have the right to determine who they treat. He also said he was afraid that he might be sued for malpractice if compli- cations arose. But others involved in the case insisted that the original hospital had adequate facilities and that it was improper to transfer a patient who was about to give birth. In 1991 a federal court of appeals upheld the fine.
Historical Perspective
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Urgent Care Centers Urgent care centers—also called immediate care cen- ters—provide walk-in care by a physician for people with minor medical emergencies, such as cut fingers, nosebleeds, sprained ankles, simple fractures, and ill- nesses such as a sore throat or the flu. These facilities also handle other problems that require only one visit or a small number of visits. Their staff usually consists of physicians (full-time and part- time), physician assistants, nurses, and clerical help. They may be owned by physicians, other private indi- viduals, or hospitals. Accreditation is available from the Joint Commis- sion and the AAAHC. The facilities are legally con- sidered the equivalent of medical offices and are not regulated by separate licensure. Some urgent care centers function as family medical centers, offering long-term care as well as episodic care. All have laboratory and x-ray facilities. Most provide prepackaged prescription services for frequently used drugs. Some participate in managed-care programs, and some have contracts to provide treatment to injured workers. The fees tend to be comparable to those of standard medical offices and much less than those of hospital emergency departments. Many give a discount when payment is made at the time of the visit.
Many urgent care centers are located in small shop- ping centers, malls, chain pharmacies, and other busy thoroughfares. These facilities have proliferated because of (a) the high cost of hospital services, (b) the realiza- tion that people can become ill or injured at any time of the day, (c) competition for patients as a result of a surplus of physicians in some communities, (d) insurance companies’ desire to reduce hospital costs by lowering reimbursements to hospitals for emergency department services, (e) the lack of physicians in some areas, (f) the tendency of physicians to refer patients to hospital emergency rooms after office hours, and (g) consumer dissatisfaction with the emergency room environment. Urgent care centers can provide care for injuries or illnesses that occur when one’s personal physician is not available. These centers do not require an appointment and generally provide quick service. They have longer hours than most medical offices, and nearly all function 7 days a week. They provide an alternative for people who do not have a regular physician, who wish to be seen for an acute problem outside their regular physi- cian’s working hours, or who are traveling away from home. For chronic conditions, or for conditions where familiarity with the patient is important for making a diagnosis or for designing a treatment plan, a primary physician is a better choice.
advantages and disadvantages oF outpatient HealtH-Care FaCilities
Table 22–1
Facility
Private medical office
Multispecialty group practice
Student health service
Urgent care center
Hospital emergency department
Hospital outpa- tient clinic
Ambulatory sur- gery center
Advantages
Maximum personal attention Relatively low cost per visit Relatively low cost per visit Consultations may be more readily avail- able
Convenient location Minimal cost Cost similar to medical office, much less than hospital emer gency department
Open long hours No appointment needed Open 24 hours a day Able to handle serious emer gencies Sophisticated equipment avail able
Fees may be reduced for indi viduals who cannot afford private care
Surgery costs less than it would in a hospital
Disadvantages
Limited hours Same physician may not always be seen (varies with setup of group)
Hours and scope of practice may be limited
When care is episodic, doctor does not get to know the patient as an individual. Extra tests may be ordered because records are unavail- able or physician does not know patient well
Highest cost Nonemergency cases may not receive much
attention Follow-up care may be minimal Care is episodic and less personal Patients may have to wait a long time to be seen Tends to have high staff turnover so dif ferent doctors may be seen
Unsuitable for major surgery
Chapter Twenty-Two Health-Care Facilities 457
Ambulatory Surgery Centers Ambulatory surgery centers (ASCs) comprise freestand- ing, independent, corporate, or hospital-owned facilities where outpatient surgery is performed after the patient has been medically evaluated elsewhere. There are more than 5000 outpatient surgery centers nationwide. Most operations done at ASCs cost less than they would in an inpatient hospital setting. The costs include charges for using the facility plus the fees of the attending surgeon, anesthesiologist, and pathologist. The common ambula- tory procedures include:
eye oPerations: Cataract removal, eye muscle surgery, refrac- tive surgery, foreign body removal
gyneCologiC ProCedures: Dilation and curettage (D&C), laparoscopy, biopsies
ear/nose/tHroat ProCedures: Tonsil and adenoid removal, drainage of fluid from the ears
ortHoPediC surgery: Biopsies, bone grafts, joint surgery, liga- ment and tendon repair, treatment of broken bones
general surgery: Removal of cysts, skin lesions, and stitches; breast and muscle biopsies; hernia repair; hemorrhoid opera- tions; and laparoscopic gallbladder removal
reConstruCtive and CosMetiC surgery: Scar revision, skin grafts, facial surgery
PodiatriC surgery: Removal of bunions, corns, and warts; surgery on bone spurs
ASCs are licensed in 43 states. About 85% are ap- proved by Medicare. Accreditation is available from the Joint Commission, the AAAHC, and the American Association for Accreditation for Ambulatory Surgery Facilities. Some communities have overnight recovery care centers for patients who need observation 24 to 48 hours following outpatient surgery.
Hospitals
Hospitals can be categorized as community or noncom- munity; general or specialty; government-owned or nongovernmental; non-profit or for-profit; and short-term (average length of stay is under 30 days) or long-term (over 30 days). In 2009 the 5795 registered hospitals in the United States had a total of 944,277 beds. Of these, 5008 (86%) were community hospitals and 998 (20%) were for-profit hospitals.10 In 2008, 31% of community hospitals had fewer than 50 beds, 20% had 50 to 99 beds, 21% had 100 to 199 beds, 19% had 200 to 399 beds, 4% had 400 to 499 beds, 5% had 500 or more beds, and the average oc- cupancy rate was 68.2%.11 Larger hospitals tend to be better equipped and staffed to provide comprehensive care.
In 2008, the Department of Veterans Affairs (VA) operated 153 hospitals, as well as 909 community-based outpatient clinics, 135 nursing homes, 47 residential rehabilitation treatment programs, 232 Veterans Centers, and 108 comprehensive home-care programs.12 In recent years the total number of hospitals in the United States has declined, but the number of inves- tor-owned, for-profit hospitals has increased. Some are chains owned by corporations listed on the stock market. Many hospitals have formed various collaborative or networking ventures, a trend that is increasing rapidly in response to economic pressures. (A network is a group of hospitals, physicians, other providers, insurers, and/or community agencies that work together to coordinate and deliver a broad spectrum of services to their com- munity.) Cost-control efforts have tightened the criteria for admission, shortened average lengths of stay, and caused many facilities to merge to achieve economies of scale and avoid duplicating services and technologies. This subject is discussed further in Chapter 24.
Accreditation The Joint Commission grants hospital accreditation for 3 years. Its decisions are (a) accreditation, (b) provisional accreditation (fails to successfully address all require- ments for improvement), (c) conditional accreditation (significant shortcomings must be corrected quickly), (d) preliminary denial of accreditation, or (e) denial of accreditation. About 80% of the hospitals in the United States are accredited. Those with fewer than 50 beds are less likely than larger hospitals to be accredited. The hospital standards include13:
• A safe, clean, uncrowded hospital with enough beds to handle the patient load.
• A well-organized administration with a chief executive and a governing body.
• Appropriate protection of the rights of patients. • Standards for ensuring that patients are appropriately as- sessed and treated.
• Provision of services such as a pharmacy, a diagnostic x- ray department, a clinical laboratory, surgical facilities, and nursing and food services, each staffed and supervised by qualified professionals. (For example, the nursing services must be supervised by registered nurses, and the pharmacy must be maintained by a registered pharmacist.)
• Procedures by which physicians apply for staff membership and are evaluated in terms of experience, judgment, ability, and competence.
• Establishment of rules and regulations for the medical staff, including the maintenance of committees to review the quality of medical care of its members. (For example, a committee must review the appropriateness of surgical
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• Has an effective tissue review committee. The committee reviews pathology reports on tissue specimens obtained during surgery to determine whether the surgery was justi- fied. If a physician appears in error, the committee expects an explanation. A physician who performs several question- able operations might be requested to appear before the executive committee of the medical staff of the hospital. When violations are sufficiently flagrant, the physician could be barred from practice at the hospital.
• Requires consultations with other physicians when diagno- ses are questionable, when great risk is involved, or when treatment procedures are in doubt.
• Holds advisory committee meetings to determine ways to run the hospital more efficiently and humanely.
• Provides the services of some type of ombudsman, or pa- tient representative, who communicates with patients and is concerned with their general welfare.
• Abides by the Patient’s Bill of Rights (see box on opposite page).
• Encourages community participation in the conduct of the hospital. It has a consumer board or a consumer represen- tative who participates in hospital planning sessions and makes recommendations for improving services.
• Is involved in community activities, such as programs for cancer screening, smoking cessation, substance-abuse treatment, and consumer education.
Selecting a Hospital There is no simple way for the average consumer to determine whether a hospital provides high-quality care. The effort that should be made depends on the patient’s situation. In an emergency where minutes count, the most practical choice may be the nearest hospital. If the doctor selected has only one hospital affiliation or the community has only one hospital, that hospital must be used if you want the doctor to manage your care. Choice may also be limited by one’s insurance coverage. For nonemergency conditions, some investigation may be prudent. Physicians who attend to hospitalized patients are in a good position to observe the quality of nursing care and other services that the hospital provides. Thus a trustworthy personal physician is probably the best source of advice about choosing a hospital. It is also prudent to know whether the cost of a hospital stay will be covered fully or partially by one’s insurance. For unusual or serious conditions, a hospital with special equipment or staff expertise may be needed. That, too, is best determined with the help of one’s personal physician. Information is also available from U.S. News & World Report, which ranks the quality of services in 16 specialties at hospitals with at least 100 beds. The rankings for four of the specialties are based on a survey of 200 randomly selected board-certified specialists. The
procedures, and a utilization review process must evaluate the appropriateness of patient admissions and lengths of stays.)
• Maintenance and safeguarding of complete and continuous medical records on each patient.
• Maintenance of infection-control procedures. (This is im- portant because hospitals are potential breeding grounds for infectious organisms, and many seriously ill patients are susceptible.)
• Regularly scheduled case conferences and other educational activities for the staff.
Well-managed hospitals carefully check the creden- tials of their medical staff and limit privileges to areas in which the individual has appropriate training and has demonstrated competence. Active staff members have full admitting privileges, are eligible to serve on hospital committees, and can vote on hospital matters. Courtesy staff members admit or co-manage a limited number of patients per year but do not participate in hospital af- fairs. Consulting staff members are permitted to perform consultations and serve on certain committees. New applicants are usually appointed to the provisional staff and are monitored for 1 year, after which they can apply for active, courtesy, or consulting status. In addition to being accredited, a good hospital:
• Is likely to be a teaching hospital affiliated with a medical school and approved for the training of resident physicians, medical students, and nurses.
• Has staff members involved in research. The care is likely to be more consistently of high quality, with practitioners having the most up-to-date medical knowledge available.
• Has a wide range of diagnostic and treatment facilities and services.
• Has a wide range of specialists, most of whom are board- certified, and employs adequate numbers of registered nurses and nursing aides.
• Uses peer review to maintain medical standards and pro- vides high-quality educational programs for its staff.
Personal Glimpse
Patient-to-Nurse Communication A 54-year-old man was hospitalized for treatment of a severe infection and pain that developed after a knee operation. The standard treatment to control that type of pain is to give medication on a regular schedule. How- ever, the patient was required to ask for every dose and found that the nurses took 45 to 60 minutes to show up after he pressed his call button. He solved this problem by telephoning the hospital switchboard and asking to be connected to the nurses’ station on his ward.14
Chapter Twenty-Two Health-Care Facilities 459
rankings for the rest are based on a survey plus analyses of death rates and several other types of objective data. The 2010–11 report, which includes a searchable data- base of the rankings, can be viewed on the magazine’s Web site (http://health.usnews.com/best-hospitals).15 Many states now collect and analyze information about hospital charges and performance, but the data they release may be difficult to interpret because patient characteristics can vary considerably from hospital to hospital and rating systems can vary from one to another in the way they rate the same data.16 Osborne and col- leagues17 concluded that, for cardiovascular operations, U.S. News and World Report’s ratings were useful in identifying high-quality hospitals, but patients could experience equivalent outcomes by seeking care at other high-volume hospitals. Researchers who studied the records of 232,342 surgical patients who had been discharged from 168 Pennsylvania hospitals have reported that serious com- plications occurred less often in hospitals that had rela- tively fewer patients assigned to each nurse.18 Consumer Reports14 advises that staffing ratios be considered when choosing a hospital, but it notes that this information can be difficult to obtain. The U.S. News & World Report Web site includes nursing staff levels in its database. Other sites that tabulate hospital data include www. checkbook.org, www.healthgrades.com, and www.jcaho.org. When a hospital has been selected, several things can be done to make one’s stay more pleasant. Leeds and
Strauss19 advise inquiring about visiting hours, restric- tions on who may visit, and availability of a telephone and a television set. Consideration should be given to the type of room desired. It can be difficult to share a semiprivate room with someone who is seriously ill and is noisy or requires frequent staff attention during the night. Most insurance policies cover the cost of a semiprivate room (a room with two to four beds). The extra cost of a private room would have to be paid out- of-pocket.
Hospitalists Hospitalists are physicians who spend at least 25% of their professional time managing hospitalized patients whom they refer to other doctors at the time of discharge. These patients may be referred by their primary-care physicians or by a hospital emergency department if the patient does not have a primary-care physician. Care by full-time hospitalists can be advantageous because they can monitor their patients closely throughout the day. However, potential problems include (a) patient dissatisfaction secondary to being “assigned” a new physician during an acutely stressful time and (b) lack of adequate communication between inpatient physicians and outpatient primary-care providers.
Problems with Inpatient Care Hospital care can entail several types of problems for consumers. The quality of care varies considerably.
A HospitAl pAtient’s Bill of RigHts
A declaration of the rights of hospitalized patients was published in 1972 by the American Hospital Association and revised in 1992.20 A document embodying these rights is usually distributed as part of the admission process. The exact wording is up to the hospital, but patients are basically entitled to:
1. Considerate and respectful care. 2. Complete information about diagnosis, treatment, prognosis, and the names of the physicians, nurses, and others
handling the patient’s case. 3. Information that enables the patient to give informed consent before any procedure or treatment starts. 4. An advance directive (such as a living will, health-care proxy, or durable power of attorney for health care) with
the expectation that the hospital will honor the intent of these directives to the extent that the law allows. 5. Privacy in the conduct of case discussion, consultation, examination, and treatment. 6. Confidentiality of communications and records. 7. Review and interpretation of their hospital records. 8. Reasonable responses to requests for services. 9. Information about the existence of business relationships among the hospital, educational institutions, other health-
care providers, or payers that may influence the patient’s care. 10. Consent or decline to participate in proposed research studies. 11. Reasonable continuity of care when hospital care is no longer appropriate. 12. Know the cost of hospital care and what hospital rules and regulations apply to the patient’s conduct while a
patient.
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has reported that at the end of 2009 there were 10,581 Medicare-certified home care agencies, 3407 Medicare- certified hospices, and thousands of noncertified facili- ties.25 NAHC has also estimated that about 12 million Americans need home care and that the total spent for purchased or compensated home care services in 2009 was about $72 billion. However, most home care ser- vices are provided by family members, friends, or other uncompensated caregivers. Most hospitals offer home care services. Many pa- tients are discharged earlier because home care can be
Patients may receive inadequate nursing attention, which can jeopardize their health or subject them to unneces- sary discomfort and inconvenience. The food may be unappetizing. Accidents, hospital-acquired infections, and other preventable complications can occur. Patients may receive the wrong drug dose or be given a drug, test, or procedure intended for someone else. In addition, hospital costs are very high, and billing errors are quite common. To reduce delivery of services to the wrong people, staff members routinely ask for verification of the patient’s name, date of birth, and/or other identify- ing information. Some of these difficulties can be prevented or overcome by prudent consumers. Consumer Reports on Health21 stresses that patients should keep informed and speak up when necessary. People who are too ill to do this should try to have a family member or friend fulfill this role. Ulene and Ulene22 advise keeping a daily diary list- ing every service performed and everything else that happened. This record should include the names of the physicians who visited, what they said, what tests or procedures were performed, and what medications were received. The record will not only help the patient understand what is taking place but will also be useful for evaluating the hospital bill. The “Strategies for Hospitalized Patients” Consumer Tip box summarizes actions advised by the aforemen- tioned authorities and others.
HoMe Care serviCes
As people age, or if impairment occurs, it is advisable to become familiar with the many types of help available in one’s community. The first step should be to determine what level of care is needed. A physician, public health nurse, social worker, or family members may help with this determination. The needed care may include 24-hour care, daily medical supervision, minimal assistance with daily activities (help with shopping, cleaning, and cook- ing meals), or other services. Home care can be defined as the provision of equipment and services to the patient in the home for the purpose of restoring and maintaining the patient’s maximum level of comfort, function, and health.23 Home care is not a single service. It is a wide range of services with two common goals: to keep the home intact and to improve quality of life by providing help in the home. It encompasses everything from help with everyday tasks of living to advanced medical care. The National Association for Home Care & Hospice (NAHC)
√ Consumer Tip
Strategies for Hospitalized Patients Be alert. Alertness may be needed to avoid receiv- ing the wrong medication or undergoing a procedure intended for someone else. Ask questions; if you are too ill to do so, ask a family member or friend to assist you. Medications. Know the names and dosages of your medications. Before taking any new drug, have the nurse check your name and any drug allergies listed on your wristband. Also ask for the name of the drug and check its appearance. If it doesn’t look like what you have previously received or what your doctor said you would be getting, have the nurse check the order book or contact your physician. Tests and procedures. You should be informed of the purpose of each and of any risk or discomfort that may be involved. Make sure you know about any special pretest preparations such as the use of laxatives, enemas, fasting, and the like. Be sure the test or procedure is for you and is relevant for your condition. If relevant, ask your doctor whether temperature and blood pressure checks can be postponed until morning rather than interrupting your sleep. Too many doctors. Know who’s in charge of your case. If doctors treating you provide conflicting infor- mation, raise questions and ask them to communicate with each other before they talk with you. Speak up. If there are problems with your food or pain control, delayed responses by nurses, curt replies to your requests, or other significant difficulties, talk to the nurse, dietitian, physician, or the hospital’s patient advocate or ombudsman. Follow-up care. Don’t leave the hospital without a clear understanding of what you need to know to care for yourself at home. Check your bill carefully. Hospital billing errors are very common. Be sure that the bill is itemized and that you understand everything listed.24
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achieved at a much lower cost. Professional home care services can include medical and skilled nursing care; speech, respiratory, physical, or occupational therapy; intravenous drug therapy; nutrition or dietary services; personal care (help with bathing, dressing, and eating); and hospice services for the terminally ill (covered in Chapter 21). Charges are usually on a “per-visit” basis, although they may be on an hourly basis. NAHC esti- mates that the median cost per home call visit in 2009 was about $28 for registered nurses, $20 for licensed practical nurses, $34 for occupational and speech thera- pists, $37 for physical therapists, $24 for respiratory therapists, $12 for home care aides, and $23 for medical social workers. Federal law requires that home health aides whose employers receive reimbursement from Medicare com- plete at least 75 hours of classroom and practical training by a registered nurse and pass a competency test. Train- ing may be administered at the home health-care agency and should include basic home nursing, personal care, safety, food, and nutrition. Sources of general information about home care in- clude (a) physicians; (b) hospital-based social and home care offices; (c) the Visiting Nurse Association (check local telephone directory); and (d) organizations such as the American Association of Retired Persons, Assisted Living Federation of America, National Association for Home Care & Hospice, and National Consumers League. Private agencies may be listed in the Yellow Pages under the headings “Home Health Services” or “Nurses.” The following questions can be helpful when select- ing a home care agency:
• How long has the agency been serving the community? • Is the agency certified by Medicare? If so, you can review its Medicare Survey Report.
• Is the agency licensed? • Does the agency do background checks when hiring staff? • Is the agency accredited by the Community Health Accredi- tation Program, the Joint Commission on Accreditation of Healthcare Organizations, and/or the National Homecar- ing Council Division of the Foundation for Hospice and Homecare?
• Does the agency provide literature explaining its services, eligibility requirements, fees, and funding sources?
• How does the agency select and train its employees? • Are the agency’s nurses required to evaluate the patient’s home care needs? If so, what does this entail? Are the patient’s physicians and family members consulted?
• Is the patient’s treatment documented with a detailed plan? Is a copy of this plan given to the patient or the patient’s family?
• What procedures are in place to handle emergencies?
• Do supervisors oversee the care? If so, how often do they visit, who can be contacted with questions and complaints, and how are problems resolved?
• Does the agency take time to educate family members on the type of care being provided?
Some of these questions can be answered with data from the Department of Health and Human Services’ Home Health Compare Web site (www.medicare.gov/ HHCompare/home.asp). An agency’s reputation can also be checked by consulting physicians, hospital discharge planners, com- munity leaders, the local health department, the local Area Agency on Aging, clients of the agency, or others familiar with its operation.
assisted living FaCilities
The term “assisted living facility” is often used to describe boarding homes, supervised individual apart- ments, and personal-care facilities that offer help with activities of daily living in a homelike atmosphere.26 In response to the aging of our population, the number and variety of assisted living arrangements have been increasing rapidly. The legal definition, scope of services, and regulation of these facilities vary from state to state. The cost depends largely on the extent of services offered and can be quite expensive.27
nursing HoMes
A nursing home is a nonhospital facility with an orga- nized professional staff that provides continuous nursing and other health-related psychosocial and personal care services to patients who are not acutely ill but require continued inpatient care. Nursing homes accept patients for reasons of in- firmity, advanced age, illness, injury, convalescence, chronic physical disability, and mental incompetence. They generally do not admit patients suffering from a communicable disease, alcoholism, drug addiction, or acute mental illness. There were few nursing homes in the United States before 1935. In that year the Social Security Act made federal funds available to the impoverished aged, giving impetus to the development of nursing homes. In 1965 amendments to the Social Security Act created Medi- care and Medicaid, which pay a large percentage of the cost of nursing home care. To receive payments under these programs, a facility must meet federal certification standards. Every nursing home that provides Medicare and Medicaid services must operate under the supervision
Part Five Other Products and Services462
of a state-licensed administrator. Licensure as a nurs- ing home administrator requires passage of the national licensing exam developed by the National Association of Boards of Examiners of Long Term Care Adminis- trators (NAB) and, in most states, a state exam is also required. Many states require applicants for the exam to hold a baccalaureate degree and to have completed an Administrator-in-Training program that is typically 6 months or 1000 hours long. Most states require 20 to 50 continuing education credits per year for relicensure. In 2004, an estimated 1.5 million people resided in 16,100 certified nursing homes throughout the United States.28 About 61% of these were for-profit. About 88% of nursing home residents were at least 65 years old, and about 45.2% were at least 85 years old. In 2009, the average yearly cost for a semiprivate room in a nursing home was $72,270 ($198/day).29 In 2002, Spillman and Lubitz30 estimated that 46% of persons who were 65 in 2002 would enter a nursing home sometime before they die. From both humanitarian and cost-containment perspectives, long-term care for elderly persons with chronic health problems is a significant societal problem. Most elderly Americans cannot afford nursing home care for even 1 year. Consequently, many chronically ill elderly have their assets depleted to the point where they qualify for Medicaid coverage. People who contemplate placing an elderly person in a nursing home need to know what facilities are available, how to judge their quality, how to deal with problems, and whether an alternative facility is suitable.
Types and Levels of Care Three general types of services are available in nursing homes. Nursing care requires the professional skills of an R.N. or L.P.N.. It includes administering oral medica- tions and injections and carrying out procedures ordered by attending physicians. Posthospitalization stroke, cardiac, and orthopedic care are available with related services, such as physical and occupational therapy, dental services, dietary consultation, laboratory and x-ray services, and a pharmaceutical dispensary. Per- sonal care services include help with walking, getting in and out of bed, bathing, dressing, and eating, as well as preparation of special diets as prescribed by a physi- cian. Residential care involves general supervision and a protective environment, including room and board. The facility may also provide for the social and spiritual needs of the resident. Nursing homes can be licensed for up to three levels of care:
sKilled nursing: Continuous nursing service on a 24-hour basis, with emphasis on restoring the patient’s functional status.
interMediate Care: Supervision by a registered nurse for at least one 8-hour shift per day for patients capable of per- forming some activities of daily living (eating, toileting, dressing, bathing, and getting from one location to another). The level of nursing care is less than that provided by skilled nursing facilities.
Custodial Care: Care in which room, board, and other nonmedical personal assistance are required, generally on a long-term basis, for individuals who are relatively functional.
Quality-of-Care Problems The minimal standards for nursing home licensure per- tain to facilities, staffing, and services. Many qualified homes participate in peer review in consultation with state affiliate members of the American Health Care Association and the Long-Term Care Council of the Joint Commission. Despite periodic inspections, nursing homes vary considerably within the established criteria. In addition, conformity with the law does not guarantee the skill of the staff, the provision of a friendly atmosphere, or the quality of the care rendered. Flagrant abuse in facilities that provide care for the elderly continues to be evident in many homes. In 1986 the Institute of Medicine31 concluded that poor-quality facilities outnumbered very good ones. Its report stated that in many government-certified facilities, residents received very inadequate—sometimes shock- ingly deficient—care likely to hasten a patient’s dete- rioration. The problems included discrimination against low-income patients, patterns of lax enforcement, and repeated noncompliance with quality standards. Congress responded to this report by including pro- visions pertaining to nursing homes in the 1987 Omnibus Budget Reconstruction Act (OBRA-87). Regulations for implementation were finalized in 1994.32 These rules include staffing requirements, comprehensive patient assessment within 14 days after admission, and measures involving patient rights. The rules also forbid restraining patients with drugs, belts, or vests unless medical neces- sity has been established. However, in 2006, Consumer Reports33 warned that despite the 1987 law, poor care was still common, especially at nursing homes run by for-profit chains, and that many states were not enforcing the relevant regulations. Deficiencies in nursing home care are tabulated in the federal Online Survey Certification and Report- ing System (OSCAR), but this database is not readily
Chapter Twenty-Two Health-Care Facilities 463
accessible to consumers. The Government Account- ability Office34 has reported that about 18% (about 2800 nursing homes) were cited for actual harm or immediate jeopardy during fiscal years 2006 and 2007.
Cost Considerations It has been said that good nursing homes are expensive, but poor ones are not cheap. The Better Business Bureau advises consumers to be wary about signing a life-care contract. It cannot be canceled, and the necessary inten- sive care, if needed, may not be provided. The Bureau also suggests caution if a large initial deposit or pledge of assets is required for admission. When the person’s resources are depleted, it may be impossible to leave if the facility proves unsatisfactory. If a deposit must be made, explore the possibility of arranging monthly pay- ments rather than liquidating assets. Institutional care may be paid for by Medicare (a federal program), Medicaid (a federal-state program), health insurance, or private funds. Medicare covers skilled nursing care for up to 100 days (20 days fully and all but $109.50 a day for 80 more days) per benefit period in a Medicare-certified nursing home, provided: (a) the care begins within 30 days of a stay of at least 3 continu- ous days in an acute-care hospital and (b) a physician certifies that skilled nursing care is required every day for the same condition that caused the hospitalization. A new benefit period begins when the patient has not had inpatient or skilled-nursing care for 60 consecutive days. Medicare does not pay for care in custodial or intermediate-care facilities. Medicaid covers long-term care in all three types of facilities for people whose income and total assets are
low enough to qualify. Medicaid coverage is arranged through the local welfare office. However, because Medicare pays considerably more than Medicaid, nursing homes prefer Medicare patients, and Medicaid patients may have to wait months or even years to gain admission. If a Medicaid patient must be transferred to a hospital, there may not be a place to return to afterward, even though the law requires nursing homes to readmit the patient to the next available bed. Health insurance and prepaid health-care plans sometimes include nursing home care as a benefit. The care usually is referred to as extended care. The cost may be high. Inquiry should be made about the criteria for coverage.
Selecting a Nursing Home Locating a suitable facility can require considerable time, effort, and patience. The following steps can help: 1. Prepare a list of nursing homes that appear suit- able. Medicare.gov (www.medicare.gov/NHCompare/ Include) contains an interactive tool that can be used to compare quality ratings and view summaries of complaints and inspection reports and other useful data for facilities certified by Medicare and Medicaid. Ad- ditional names might be available from a hospital social service department (“discharge planner”), other local social agency, medical care providers, and friends and relatives. Telephone several nursing homes to determine what services they provide and whether they have beds available. 2. Visit several homes to inspect the facilities, review inspection reports, verify implementation of the Nursing Home Patient’s Bill of Rights, and obtain information
To achieve Medicare and Medicaid certification, nursing homes must meet federal standards that include offering these rights to their residents:
• The right to choose your own doctors and to help plan your course of treatment. • Freedom from physical and mental abuse and from any restraints not medically required. • Use of pharmacologic drugs by prescription and only for the symptoms for which they are prescribed. • The right to privacy. • Confidentiality of records. • The right to services tailored to the resident’s individual needs and advanced notice before room or roommate is changed.
• The right to voice grievances. • The right to organize and participate in resident groups. • The right to participate in social, religious, and community activities. • The right to examine the most recent report of the facility and to review plans to correct deficiencies. • Any other right established by the Secretary of Health and Human Services.
A nuRsing Home pAtient’s Bill of RigHts
Part Five Other Products and Services464
about fees and payment schedules. An initial guided tour should be scheduled, but additional unannounced visits should be made. State licensing agencies are supposed to provide copies of inspection reports, but Consumer Reports21 advises that if the latest report is not available at the facility itself, assume it has something to hide and cross it off your list. 3. Obtain complete information about costs, payment policies, and other details. These should include room rates and extra charges for services and supplies (for physician, physical therapist, private nursing services, medications, laundry, haircuts, and special diets). If pay- ment is required in advance, discuss the policy concern- ing refunds for unused portions. Higher cost may mean that facilities have more nurses and other staff members. However, they do not guarantee better care. 4. Before signing a contract, it is advisable to have an attorney review it. A good contract should include (a) permission for the patient or family to purchase sup- plies, medications, and equipment on the open market if so desired; (b) a clear statement of the behavior or financial condition that will precipitate eviction; and (c) a refund for any unused time when a patient leaves. It is undesirable to (a) absolve the home from financial liability for injury or theft; (b) waive the right to advance notice of changes in patient care or charges for services; (c) guarantee to pay all costs of litigation, including a nursing home attorney, if the home is sued; or (d) bar cancellation of a life-care contract (unless a trial period of at least 60 days of residence is permitted). 5. After narrowing the choices to one or two, make an unannounced visit at a mealtime to determine the quality of the food and food service. An evening or night visit might be advisable as well. These visits will provide opportunities to judge the quality of care when the staff is not primed to impress visitors. Observe the activities and talk with the patients: Do they seem interested in life? Does the staff show concern for the patients? Anticipating and Handling Problems Laws alone cannot ensure quality care. Family members or other concerned parties should not only select places carefully, but should also observe the quality of patient care after admission. Federal regulations require nursing homes to record and periodically update a management plan for each patient. Concerned parties can request a copy of the plan of care and monitor its implementation. Problems that arise should be discussed with the nursing staff and, if necessary, with the nursing home administrator. If this is unsuccessful, complaints can be made to the local Social Security office, the patient’s
caseworker (if covered by Medicaid), a nursing home ombudsman, the state licensing board, the local Better Business Bureau, or an attorney.
Continuing Care retireMent CoMMunities Continuing care retirement communities (CCRCs) provide lodging, nursing services, medical services, or other health-related services pursuant to a contract either for life or for a period of one or more years. CCRCs are generally a collection of apartments, town homes, and/ or cottages and include common activity areas such as a library, activity and craft rooms, a restaurant-like dining room, an assisted living facility, and a nursing home. Oth- er amenities may include banking services, convenience stores, walking trails, gardens, swimming pool, fitness center, beauty/barber shops, and guest accommodations. The entry requirements usually include a large deposit plus monthly maintenance payments. The amount of the entry fee, which can range from a few thousand dollars to over $1 million, may depend on the size and type of dwelling chosen, the applicant’s age, and how much of the deposit might be returned if the participant dies or leaves the CCRC. Typically, there are three levels of care: independent living, assisted living, and skilled nursing. The most expensive plans cover all residential and health-related services with the entrance and monthly fees. Less expen- sive plans involve additional charges if assisted living or skilled nursing services are needed. Table 22-2 summarizes the various types of com- munity assistance and their relative costs.
suMMarY
Many types of community facilities are available to help with illnesses and infirmities. Outpatient medical facilities include private medical offices, student health services, work-related facilities, urgent care centers, ambulatory surgical centers, and hospital emergency departments and outpatient clinics. Inpatient facilities include hospitals and nursing homes. A wide variety of home care services may enable dis- abled individuals to avoid institutionalization. More than 20,000 facilities are accredited by the Joint Commis- sion on Accreditation of Healthcare Organizations and other accrediting agencies. The best choice of facility depends on the type and urgency of the problem as well as insurance coverage and other financial considerations. Prudent consumers know and try to avoid the pitfalls of the various facilities.
Chapter Twenty-Two Health-Care Facilities 465
Type
Boarding facility
Congregate housing
Day care
Domiciliary care
Emergency re- sponse system
Home health care
Home visitor/ companion
Home-delivered meals
Hospice
Continuing care retirement community (life-care community)
Nursing home
Personal care facility
Respite care
Rest home
Senior centers
Shared housing
Special housing
Telephone reas- surance
Transportation service
sCope and relative Cost oF long-terM–Care FaCilities and serviCes
Table 22–2
Scope Room, meals, housekeeping services, and possibly personal care
services
Apartment complexes that offer meals, housekeeping, and health- care services
Supervised lunch, recreational and social activities, and other services for ambulatory patients
Supervised residential programs for elderly, physically impaired, mentally ill, or mentally retarded people
Portable or wall-mounted devices that can signal a monitoring service that contacts an appropriate agency or family member for help (see Chapter 20)
Wide range of health and personal services
Volunteers visit ailing seniors
Delivery of prepared food, usually weekdays only; typically called “Meals on Wheels”
Full range of services for the terminally ill (see Chapter 20)
Housing and services that range from independent living to skilled nursing care. Apartments for “well elderly” typically include close medical monitoring; dietary and housekeeping services; social, recreational, and spiritual services; and nursing care when needed
Three levels of service: skilled, intermediate, and custodial
Custodial care in which the facility supplies individual rooms and supportive services in return for a monthly fee
Short-term care in the home or an institution to temporarily re- lieve the home caregiver; may be used to help in recovery from illness or enable a family to take a vacation
Custodial care; may include the services of a visiting nurse
Social, recreational, and educational activities
House or apartment occupied by a few people, each with his or her own bedroom; supervised by a public or private agency; may provide services such as cleaning, shopping, cooking, and nurse visits
Apartment buildings specially designed for the elderly
Homebound individual “checks in” or is contacted by a desig- nated person or agency at specified times
Transportation to medical appointments and other essential activities
Relative Cost Moderate
Moderate
No fee, sliding scale, or full fee (expensive)
Low to moderate; may be covered by Medicaid
Moderate; costs include an installation fee plus a monthly charge for the monitoring
Varies; may be based on ability to pay
None
Low or nominal
Expensive but usually covered by Medicare
Expensive; large entry fee plus monthly fees based on extent of services
Depends on level of care, but all are expensive
Expensive but usually less than nursing home
Varies
Moderate
Nominal
Low to moderate; may be based on ability to pay
Eligibility and rent usually based on ability to pay
None
Free or nominal
Part Five Other Products and Services466
reFerenCes
1. Baer K. How to pick the right hospital. Harvard Health Letter, Special Supplement, July 1995.
2. Nursing homes: When a loved one needs care. Consumer Re- ports 60:518–528, 1995.
3. Editors of Consumer Reports Books. Foreword to Nassif JZ. The Home Health Care Solution. Yonkers, N.Y., 1985, Consumer Reports Books.
4. Facts about Joint Commission accreditation and certification. Joint Commission Web site, Nov 2010.
5. Hsaio C-J and others. National Ambulatory Medical Care Sur- vey: 2007 summary. National Health Statistics Reports, No. 27, Nov 3, 2010.
6. Patient dumping case goes to court. Public Citizen Health Research Group Health Letter 7(5):3, 1991.
7. Fabiano P and others. Standards of practice for health promotion in higher education. Hanover, Md., 2002, American College Health Association.
8. Isaacs SL, Swartz AC. The Consumer’s Legal Guide to Today’s Health Care: Your Medical Rights and How to Assert Them. Boston, 1992, Houghton Mifflin Co.
9. Trauma center. Wikipedia, accessed Sept 23, 2011. 10. Health, United States, 2010. Hyattsville, Md., 2011, National
Center for Health Statistics. 11. AHA Hospital Statistics. Washington, D.C., 2011, American
Hospital Association. 12. Facts about the Department of Veterans Affairs. VA Web site,
January 2009. 13. Hospital accreditation: What it means and how it works.
Oakbrook, Ill., 1996, Joint Commission on Accreditation of Healthcare Organizations.
14. How safe is your hospital? Consumer Reports 68(1):12–18, 2003. 15. Best Hospitals 2011–2012. U.S. News & World Report Web
site, accessed Oct 25, 2011. 16. Shahian DM and others. Variability in the measurement of
hospital-wide mortality rates. New England Journal of Medicine 363:2530–2539, 2010.
17. Osborne NH and others. Do popular media and internet-based hospital quality ratings identify hospitals with better cardio- vascular surgery outcomes? Journal of the American College of Surgery 210:87–92, 2010.
18. Aiken LH and others. Hospital nurse staffing and patient mortali- ty, nurse burnout, and job dissatisfaction JAMA 288:1987–1993, 2002.
19. Leeds D, Strauss JM. Smart Questions to Ask Your Doctor. New York, 1992, HarperCollins.
20. A Patient’s Bill of Rights. Chicago, 1992, American Hospital Association.
21. Avoiding hospital blunders: Knowing the risks and speaking up can help you stay safe. Consumer Reports on Health 12(6):1–5, 2000.
22. Ulene A, Ulene V. How to Cut Your Medical Bills. Berkeley, Calif., 1994, Ulysses Press.
23. Scott WC and others. Home care in the 1990s. JAMA 263:1241– 1244, 1991.
24. Decoding your hospital bills. Consumer Reports 68(1):19, 21–23, 2003.
25. Basic statistics about home care. Washington, D.C., 2010, National Association for Home Care & Hospice.
26. Wright B. Assisted living in the United States. American As- sociation of Retired Persons Web site, Oct 2004.
27. Is assisted living the right choice? The promise and the pitfalls of a residential option designed to fill the gap between independent living and nursing-home care. Consumer Reports 66(1):26–31, 2001.
28. The National Nursing Home Survey: 2004 Overview. Vital Health Statistics Series 13, No. 167, June 2009.
29. The 2009 MetLife Market Survey of Nursing Home, Assisted Living, Adult Day Services, and Home Care Costs. Westport, Conn., 2009, MetLife Mature Market Institute.
30. Spillman BC, Lubitz J. New estimates of lifetime nursing home use: Have patterns of use changed? Medical Care 40:965–975, 2002.
31. Institute of Medicine Committee on Nursing Home Regulation. Improving the Quality of Care in Nursing Homes. Washington, D.C., 1986, National Academy Press.
32. Health Care Financing Administration. Medicare and Medicaid programs: Survey, certification, and enforcement of skilled nurs- ing facilities and nursing facilities. Final rule. Federal Register 59:56116–56252, 1994.
33. Business as usual: Two decades after passage of a federal law to clean up the nation’s nursing homes, bad care persists and good homes are still hard to find. Consumer Reports 71(9):38–41, 2006.
34. Nursing Homes: Federal Monitoring Surveys Demonstrate Continued Understatement of Serious Care Problems and CMS Oversight Weaknesses. GAO-08-517. Washington, D.C., 2008, Government Accountability Office.
1. You have been advised to enter a hospital for elective surgery. What information about the hospital would help you be prepared?
2. An elderly member of your family is unable to manage several activities of daily living. What steps can be taken to determine what he or she needs and how these needs can be met?
It’s Your Decision
HealtH Insurance
Shopping for health insurance ranks somewhere between grout- ing the tub and giving blood. A good thing, a necessary thing, but, at best, a chore.
Paul Cohen1
Bring together any group of citizens and the dimensions of the health care crisis emerge from their stories. Stories about insur- ance coverage lost, policies cancelled, fear of financial ruin, better jobs not taken, endless forms filled out. They are stories of frustration and insecurity—and, too often, pain and fear.
hillary rodham Clinton2
“While I can explain the meaning of life, I don’t dare try to interpret insurance policies.”
Chapter OnePart Six Chapter Twenty-Three
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Part Six Protection of the Consumer468
Health insurance can help people budget by pay- ing in advance for relatively predictable types of health-care expenses. It can also protect
against costs that are less predictable and can be ruin- ously high. This is important because hospital care costs over $1800 a day3 and surgical procedures can cost thousands apiece. This chapter discusses the types of benefits and plans, provides guidelines for selecting coverage, ex- plains the procedures used to collect benefits, warns against bogus plans, and briefly describes disability insurance. This chapter also summarizes how the Patient Protection and Affordable Care Act (PPACA), will lead to many changes in the health insurance marketplace. Chapter 24 covers fraud committed against insurance providers.
Background
Modern health insurance in the United States began as hospital insurance in 1929, when a Dallas hospital ad- ministrator told a group of local schoolteachers that for 50¢ a month per teacher his hospital would provide up to 20 days of care. In the 1930s and through World War II health insurance expanded to cover hospital, surgical, and medical services, and employers began to include it in collective bargaining contracts. In the early 1950s insurers began offering major medical policies that cov- ered the cost of illnesses requiring long hospital stays or other extensive treatment. Protection grew rapidly and, by the mid-1950s, 77 million people had coverage for hospital expenses.4 During the next few years, insurance companies began offering high-benefit major medical plans and comprehensive coverage with limits placed on out-of-
pocket expenses (100% of costs beyond set limits were covered by most insurance plans). Medicare (primarily for people older than 65) and Medicaid (for certain low- income populations) became available in 1966. In the 1970s escalating health-care costs stimu- lated rapid growth of health maintenance organizations (HMOs), preferred provider organizations (PPOs), and other types of managed-care plans. In 2008, approxi- mately 301 million Americans (84.6% of the total U.S. population) were covered to some extent by private and/or public insurance.5 The PPACA, enacted in 2010 in an attempt to make high-quality care more afford- able, includes provisions for greater coverage as well as programs that are intended to control costs. Insurance programs are regulated primarily by state insurance departments. Regulations vary considerably from state to state.
compreHensIve medIcal Insurance
Comprehensive medical insurance basically combines basic and major medical coverage. It costs more than either one alone but is usually less expensive than the same coverage purchased in two or more separate poli- cies. It also avoids duplication and coverage gaps that can occur with separate policies. Comprehensive medical plans tend to have a moderate deductible, co-insurance, and an annual limit on out-of-pocket expenses. When that limit is reached, the policy covers all further ex- penses for the year.
Basic Health Insurance Basic health insurance includes benefits for hospital, surgical, and medical expenses. The extent of these benefits differs from contract to contract.
• Adequate insurance coverage is important because medical and hospital bills can be enormous.
• Coverage is available through private and public (government-sponsored) plans. The key factors in choosing a plan are (a) whether it covers the services you are most likely to use and (b) whether you can afford it.
• Managed-care policies tend to cost less than traditional fee-for-service policies and to result in fewer out-of-pocket expenses. Their chief drawback is limited choice of provider.
• Group policies tend to cost less and provide better benefits than individual policies.
• Hospital indemnity policies, “dread disease” policies, and most other mail-order policies tend to be overpriced and too limited to be worth considering.
• It is very important for people with insurance to understand the extent of coverage, to follow their plan’s rules, and to be assertive if problems arise.
keep tHese poInts In mInd as You studY tHIs cHapter
Key Concepts
Chapter Twenty-Three Health Insurance 469
glossarY of common Insurance terms
Table 23–1
assignment of benefits: By signing a form (usually the insurance claim form), you authorize the insurance company to pay the physician directly. Otherwise pay- ment must be made directly to you. Most physicians will ask you to sign the form if you don’t want to pay your bill before the insurance company pays its share.
CaPitation: Payment to health providers according to the number of patients they agree to serve rather than the amount of service rendered.
Claim form: Form stating what information an insurance company needs to make payment. Many providers sub- mit this information electronically rather than on paper.
Co-insuranCe: Arrangement whereby the patient and the insurance company share costs. The insurer typically pays 75% to 80% of covered costs beyond any deduct- ible amount, and the patient pays the rest. Some policies set an upper limit to co-insurance expense, after which the company pays all additional charges.
Conversion Privilege: Provision that enables those insured by group contracts to obtain an individual policy under various circumstances, such as leaving the job that provided the group coverage.
Coordination of benefits: Provision that prohibits collect- ing identical benefits from two or more policies, thereby profiting when you are ill. After the primary company pays, other companies calculate their coverage of the remainder. All group policies contain a coordination clause, but some individual policies do not.
Co-Payment: Fixed dollar amount paid whenever an in- sured person receives specified health-care services.
deduCtible: The amount you must pay before the insur- ance company starts paying.
endorsement or rider: Attachment to the basic insurance policy that changes its coverage to provide additional benefits, limitations, or exclusions.
exClusions: Specified conditions or circumstances for which the policy does not provide benefits.
gatekeePer: Health-care provider, usually a primary care specialist, who supervises all aspects of a patient’s care and must authorize care (except in emergencies) from other providers before the plan will pay for it.
graCe Period: Number of days that you may delay pay- ment of your premium without losing your insurance.
guaranteed renewability: Policy where the company agrees to continue insuring you up to a certain age (or for life) as long as you pay the premium. Under this provision, the premium structure cannot be raised un- less it is raised for all members of a group or class of insured, such as all people living in your state with the same kind of policy.
indemnity Carrier: Insurance company or other organiza-
tion offering specified coverage within a framework of fee schedules, limitations, and exclusions.
inPatient serviCes: Services received while hospitalized. managed Care: Health-care system (such as an HMO or PPO) that integrates the financing and delivery of services by using selected providers, utilization review, and financial incentives for members who use the pro- viders and procedures authorized by the plan.
oPen enrollment: Period during which insurance plan must accept eligible people regardless of their health status.
outPatient serviCes: Services obtained at a hospital by people who are not confined to the hospital.
PartiCiPating PhysiCian: Physician who agrees to abide by the rules of a plan in return for direct payment by the insurance company. The agreement includes ac- ceptance of a fixed fee schedule, a monthly fee per eligible patient, or other fee limitation.
Pre-existing Condition: Health problem a person had before becoming insured. Some policies exclude these conditions, whereas others do not.
PartiCiPating Provider: Health-care provider who has con- tracted with an insurance company to provide services to insured individuals under specified conditions. The conditions may include fee limits, utilization review, continuing education requirements, availability during specified hours, and several other factors.
Portability: The legal right, after employment terminates, to transfer from a group insurance plan to another group or individual plan.
Provider: Any source of health-care services, such as a hospital, physician, pharmacist, or laboratory.
quality assuranCe: Internal peer-review process that audits the quality of care delivered. The process should include a mechanism to identify and prevent discrepan- cies in care.
reasonable Charge: The amount a company will pay for a given service based on what most providers charge for them.
subsCriber: Individual who contracts for health insurance coverage.
utilization review: A process for determining whether services are medically necessary and appropriate.
waiting Period: Specified time between issuance of a policy and coverage of certain conditions. Typically there are waiting periods for maternity benefits and pre-existing conditions. Also called elimination period.
waiver of Premium: Policy provision that, under certain conditions, an insurance policy will remain in force without further payments by the policyholder. It is used most often in cases of permanent and total disability.
Part Six Protection of the Consumer470
Hospital benefits may pay specified amounts for a specified number of days, which may or may not pay all the costs. Many policies cover the full charges for daily room (usually semiprivate), board, routine nursing services, and intensive care up to a maximum number of days. The insured individual may be responsible for pay- ment of a specific amount (deductible) before coverage begins or may be required to pay a percentage of costs (co-insurance). Additional benefits may be provided up to a fixed dollar amount or for the full cost of other inpatient services (other than physicians’ fees) such as laboratory tests, drugs, diagnostic x-ray procedures, operating room, anesthesia equipment use, surgical dressings, and physical therapy. Surgical benefits after any deductible generally pay a surgeon’s fee up to a specific limit set forth in the contract (commonly 80% of charges), or the insurer may agree to pay the full amount up to but not exceeding the surgeon’s “usual, customary, and reasonable” (UCR) fee. (See Table 23-1, page 469, for definitions of these terms.) Coverage for outpatient (ambulatory) surgery is usually similar to coverage for inpatient surgery. Medical benefits provide for payment of nonsurgi- cal physician’s fees. They may cover UCR charges or a stated amount for each hospital visit by the attending physician. They generally pay 80% of the bills, includ- ing prescription drugs, laboratory tests, private nurses, and other out-of-hospital care. They may also include the maximum number of visits or dollar amounts to be paid for office and home calls plus other professional services. These medical benefits are usually available only with other basic coverages such as hospital and surgical insurance. Under most plans, fees in urgent care centers are considered the same way as fees in any physician office. Hospital-based specialists, such as pathologists, radiologists, and anesthesiologists, may bill patients directly for their services. This can provide unexpected expense, particularly if the provider is not a participant in an individual’s health plan. For this reason, when time permits, it is advisable for consumers to carefully investigate the extent of their coverage. Maternity care has been treated as a separate cat- egory in some policies. Hospital care for childbirth may be paid in full, or a maximum amount may be specified. Physicians’ fees are usually covered according to a schedule of benefits, with higher amounts permitted for complicated procedures. When available, major medi- cal contracts often cover complications of pregnancy (for example, cesarean section) if expenses exceed maximum benefits of the basic health insurance plan.
The Newborns’ and Mothers’ Health Protection Act of 19966 prohibits group health plans, insurance companies, and HMOs that are subject to the Act from restricting benefits for a hospital stay for childbirth to less than 48 hours after a vaginal delivery or 96 hours after a cesar- ean delivery. Earlier discharge is possible if the patient agrees, but the insurance company cannot reward the attending physician for doing this. The PPACA includes maternity care in the standard benefits package (see page 473) scheduled for implementation in 2014. Skilled nursing care benefits provide a fixed daily allowance or full charges for a certain type of room for a maximum number of days, usually within a limited number of days after discharge from a hospital. Payment is provided only for medically necessary services, not for mere residential or custodial care. Skilled nursing is much more likely to be covered in major medical poli- cies than in basic insurance. Benefits for mental or emotional disorders are often treated as a separate category and offered as a rider. Some policies have a deductible or co-insurance provision that applies to psychiatric treatment. Other contracts exclude or limit coverage. Some policies provide coverage for vision care, dental care, and prescribed drugs. The Mental Health Parity and Addiction Equity Act of 20087 requires group health plans and health insurance issuers to ensure that financial requirements (such as co-pays, deductibles) and treatment limitations (such as visit and lifetime limits) applicable to mental health or substance use disorder benefits are no more restrictive than those applied to medical and surgical benefits. The rules apply to plans sold to employers with 50 or more employees.
Major Medical Coverage Major medical contracts are designed to offset large medical expenses resulting from prolonged illness or serious injury. They take over where basic insurance plans leave off. Major medical policies usually contain deductible and co-insurance provisions. The deductible amount may vary from $50 to $1000 or more. Co- insurance is usually 20%. Many policies have a “stop-loss” feature that limits out-of-pocket expenses in any year. For example, the insurer may pay 100% of all expenses over $1500 for one person or $3000 for a family within a 1-year period. Maximum lifetime benefits can range from $50,000 to $1 million or can be unlimited. Because most health insur- ance claims fall within basic coverage, it is possible to buy high maximum benefits under major medical poli- cies for a relatively small increase in premium. It is also possible to purchase an excess major medical policy with
Chapter Twenty-Three Health Insurance 471
a very high maximum lifetime benefit and a deductible of $15,000 or more. Major medical insurance generally covers ev- ery type of medically necessary care prescribed by a physician both in and out of the hospital. It can include office visits, nursing care (including special duty nurses), physical therapy, accident-related dental services, du- rable medical equipment (such as a respirator or feeding device), emergency ambulance service, prescription drugs, prosthetic appliances, pediatric immunizations, and psychiatric care or rehabilitation. The following are desirable components.
Convertibility: Ensures conversion to an individual policy if a person changes jobs or divorces.
renewability: Guarantees renewability to age 65 and conver- sion to Medicare.
maximum benefits: Covers expenses of $1 million or more for each family member.
deduCtible: The lower the deductible, the less that needs to be paid out of pocket for particular services. However, low deductibles require higher monthly premiums.
Co-insuranCe: 20% to 25% up to a cutoff point of $1500 to $3000, after which the insurer should pay 100%.
Changes in Coverage: Insurer may not reduce benefits or coverage.
hosPital exPense limit: Should be at least as high as the daily semiprivate room charges in one’s area.
intensive and CardiaC Care: Should be fully covered. Private nursing: Provision should include care both in and out of the hospital when specified by physician, usually with a limit.
PsyChiatriC: At least 50% of the psychiatric bills in and out of the hospital; should have a $10,000 or higher benefit limit.
ConvalesCent home Care: Coverage should include 60 to 120 days; benefits usually are about half of the daily hospital limits.
blood, Plasma, and ProsthetiCs: Should be fully covered.
contract provIsIons
A health insurance policy is a business agreement for- malized by a written contract that details both benefits and obligations. When selecting insurance it is useful to understand the significance of the following terms. Waiting periods. When medical examinations are not required, coverage generally does not become ef- fective until a probationary period, typically 3 months, has elapsed. Maternity benefits may not be granted until 10 to 12 months after a policy has been issued. There may also be waiting periods for surgery involving the tonsils, adenoids, and appendix, as well as for hemor- rhoid surgery and hernia repair. Specific waiting periods
may be imposed if an illness or disorder is identified in a subscriber’s health history. There is typically no waiting period when someone shifts from one employer-offered plan to another during an open enrollment period. Pre-existing illness. An illness or a condition due to injury that is present prior to the contract’s date is often excluded from coverage for a specific time, often 1 year. Some contracts deny coverage for illnesses that were present when the policy was taken out, even if an indi- vidual was unaware of them. The PPACA enables people who have been denied affordable coverage because of a preexisting condition and have been uninsured for at least 6 months to obtain coverage through a government-run Pre-Existing Condition Insurance Plan.8 In 2014, afford- able health insurance choices will be available through an insurance exchange (see Table 23-2). Conversion privileges. Many group contracts contain a clause that allows an employee, when leaving a job or in the case of marriage, death, divorce, having a child, or reaching maximum age, to convert all or part of the contract to an individual or family plan. There is usually a limit of 15 to 30 days for converting. Coverage in other countries. Many contracts cover medical care wherever received. Exclusions. Most contracts exclude coverage for care in hospitals owned and operated by the federal govern- ment and for injuries or diseases covered by worker’s compensation laws. In addition, conditions resulting from acts of war, riot, and military duty are excluded. Most basic policies do not pay for dental services, hear- ing aids, or vision aids. Dependent coverage. Dependents can be protected under a family plan. Coverage for infants may begin at birth or several weeks afterward. Other dependent children must be covered up to age 26. Coverage is usually dropped automatically when children reach the maximum age listed in the contract, marry, or enter the armed forces, but some policies continue coverage for totally disabled or handicapped children as long as they are dependent. Some plans cover spouses or civil union partners as dependents. Dependents may have the op- tion of converting their terminating coverage to policies of their own, regardless of medical history. Because the premiums for such individual coverage are higher, it is best to keep dependents under family coverage for as long as the policy allows. Some policies provide fewer benefits to family members than to the principal insured person. Coordination of benefits. When someone is eligible for benefits under more than one contract or policy, a
(Continued on page 474)
Part Six Protection of the Consumer472
major provIsIons of tHe patIent protectIon and affordaBle care act* Table 23-2
2010 • Coverage for young adults: Parents will be able to
keep their children on their health policies until they turn 26.
• Small-business tax credits: Small businesses (fewer than 25 employees and average wages under $50,000) that offer health-care benefits and contribute at least 50% of the premium will be eligible for tax credits of up to 35% of their premium costs for two years. The credit rises to 50% of their premium costs in 2014.
• Preexisting Condition Insurance Plan (PCIP): People with preexisting conditions who have been uninsured for at least six months will have access to affordable insurance through a temporary Preexisting Condition Insurance Plan in their state. Premiums will be based on the health status of a standard population and can- not vary by more than a factor of four based on age. Annual out-of-pocket costs will be capped at $5950 for individuals and $11,900 for families.
• New insurance rules: Insurance companies will be banned from rescinding people’s coverage when they get sick, and from imposing lifetime caps on coverage. Annual limits on benefits are phased out by 2014.
• Protection for children: Insurers can no longer deny health coverage to children with preexisting conditions or exclude their conditions from coverage.
• “Doughnut hole” rebates: Medicare will provide $250 rebate to beneficiaries who hit the Part D prescription drug coverage gap known as the “doughnut hole.”
• Preventive care: All new group and individual health plans will be required to provide free preventive care for recommended preventive services and immunizations. In 2011, Medicare also will provide free preventive care.
• Payment reform: A Medicaid demonstration project will enable safety-net hospitals in up to five states to move from a fee-for-service payment model to a global fee model. Medicare will also take temporary steps to ensure that rural areas are protected from fluctuations in payment levels to physicians and hospitals.
• Workforce improvements: Student loan programs for those training in primary care, nursing, and pediatrics will be expanded and a new National Health Care Workforce Commission will make recommendations for further action.
• Early retirees: A temporary reinsurance program will help offset the costs of expensive premiums for employ- ers providing retiree health benefits.
• Access to care: Funding will be increased by $11 bil- lion over five years for community health centers and the National Health Services Corps to serve more low- income and uninsured people.
• Quality improvement: An Interagency Working Group on Health Care Quality will issue a report to Congress with recommendations for improved collaboration between federal departments and agencies and the alignment of public and private initiatives.
• Annual review of premium increases: Health insurers will be required to submit justification for unreasonable premium increases to the federal and relevant state governments before they take effect, and to report the share of premiums spent on nonmedical costs.
2011
• Limits on nonmedical spending by health plans: Health plans in the large-group market that spend less than 85% of their premiums on medical care, and plans in the small-group and individual markets that spend less than 80% on medical care, will be required to offer rebates to enrollees.
• “Doughnut hole” discounts: Medicare beneficiaries in the Part D prescription drug coverage “doughnut hole” will receive 50% discounts on all brand-name drugs. By 2020, the “doughnut hole” coverage gap will be closed.
• Physician quality reporting: Medicare will launch a Physician Compare Web site where beneficiaries can compare measures of physician quality and patient experience. Medicare’s Nursing Home Compare Web site will publish more data about nursing facilities, including summaries of substantiated complaints.
• New payment and delivery approaches: A new Center for Medicare and Medicaid Innovation will test reforms that reward providers for quality of care rather than volume of services. Medicare will increase payment for primary care physicians by 10% for primary care services.
• Long-term care insurance program: Establishes a national, voluntary insurance program for purchasing community living assistance services and supports (CLASS). Participating employers will be required to automatically enroll employees 18 and over, but em- ployees will have the option to opt out of the program.
• Pharmaceutical manufacturer fee: Manufacturers and importers of branded drugs will have to pay an annual, nondeductible fee, based on market share.
• OTC drug reimbursement restrictions: Over-the- counter drugs not prescribed by a doctor will no longer be reimbursable through flexible spending accounts or health reimbursement arrangements, or on a tax-free basis in health savings accounts.
• Benefit disclosure: Employers will be required to disclose the value of benefits provided for each em- ployee’s health insurance coverage on the employee’s W-2 forms.
Chapter Twenty-Three Health Insurance 473
major provIsIons of tHe patIent protectIon and affordaBle care act – Cont’d. Table 23-2
2014 • Essential benefits package: The Department of Health
and Human Services will establish an essential standard benefits package for policies sold in the exchanges and individual and small-group markets with a choice among tiers of plans (bronze, silver, gold, and platinum) that have different levels of cost-sharing.
• Independent payment advisory board: A new inde- pendent payment advisory board within the executive branch will work to identify areas of waste and federal budget savings in Medicare. The board’s recommen- dations must not ration care, raise taxes, or change Medicare benefits, eligibility, or cost-sharing.
• Insurance industry fee: Insurers will pay an annual fee, based on market share, to help pay for reform.
• New rules for insurers: Insurers will be banned from restricting coverage or basing premiums on health status or gender.
• Premium subsidies: Premium and cost-sharing assis- tance on a sliding scale will make coverage affordable for families with annual incomes between $30,000 and $88,000 that buy plans through the exchanges.
• Shared responsibility for coverage: Individuals will be required to carry health insurance or pay a penalty, with some exceptions, and employers with 50 or more workers will be required to offer health benefits or be subject to a fine of $2000 per employee (not counting the first 30 employees) if any worker receives federal premium subsidies for plans purchased through the insurance exchanges.
• Insurance exchanges: New state-based marketplaces will offer small businesses and people without employer coverage a choice of affordable health plans that meet new essential benefit standards.
• Medicaid expansion: Medicaid eligibility will be ex- panded to all legal residents with incomes up to 133% of the federal poverty level. Currently, states have different—and in many cases very low—eligibility thresholds, and most states do not cover adults without children.
• Medicare managed care plans: Four- and five-star Medicare private plans will receive 5% bonuses as a reward for providing better clinical quality and patient experiences.
2018 • High-cost insurance plans: A 40% excise tax will be
levied at the insurer level on policies with premiums over $10,200 for individuals or $27,500 for family coverage. The premium thresholds will be higher for retirees and workers in higher risk industries and will be adjusted for their age and gender.
2012 • Hospital readmissions: Medicare will reduce payments
to hospitals for potentially preventable readmissions for select conditions. Hospital readmission rates for these conditions will be published on the Hospital Compare Web site.
• Accountable care: Medicare will launch a program that encourages providers to organize into accountable care organizations, which will share in savings generated by meeting quality targets and reducing costs.
• Hospital value-based purchasing program: Medicare will reward hospitals that provide higher quality or bet- ter patient outcomes.
• Understanding health disparities: Any federally conducted or supported health program, activity, or survey must collect and report data on race, ethnicity, sex, primary language, and disability status. The HHS Secretary will analyze the data for trends in health disparities at the state and federal levels and publish the data and findings online.
2013 • Administrative simplification: Health insurers must
follow administrative simplification standards for electronic exchange of health information to reduce paperwork and administrative costs.
• Payment reform: A Medicare pilot program will evalu- ate how payment for post-acute services can be bundled with payment for an episode of care such as surgery. States will pay Medicaid providers rates that are at least equal to Medicare payment rates for primary care delivered through December 31, 2014.
• Flexible spending limits: Contributions to flexible spending accounts (FSAs) will be limited to $2500 a year, indexed to the Consumer Price Index (CPI).
• Medicare taxes: In addition to the 1.45% employee portion of the Medicare Hospital Insurance tax cur- rently imposed on wages, a 0.9% Medicare tax will be imposed on every taxpayer who receives wages or self- employment income in excess of $200,000 ($250,000 adjusted gross income in the case of a joint return). Also, a new 3.8% tax will apply to “unearned” income for certain high-income taxpayers.
• Preventive services in Medicaid: The current state Medicaid option to provide diagnostic, screening, pre- ventive, and rehabilitation services will be expanded to include more services. If a state Medicaid plan chooses to offer these preventive benefits and prohibits cost-sharing, the state will receive an increased federal medical assistance percentage (FMAP) contribution of 1 percentage point for these services.
*© Commonwealth Foundation.9 Reproduced with permission.
Part Six Protection of the Consumer474
coordination of benefits provision may apply. This limits payment so the total amount paid under all contracts does not exceed the medical expenses incurred. Cancellation and renewal provisions. The PPACA requires that coverage still offered in the group or in- dividual market must continue in force if desired by the plan sponsor or the individual. Coverage may be rescinded only for fraud or intentional misrepresentation of material fact when the policy is obtained.
Portability People covered by a group plan at work have certain rights if their employment is terminated. The 1986 Con- solidated Omnibus Budget Reconciliation Act (COBRA) gives an employee who quits or has been laid off the right to remain in the company’s plan for 18 months (or 36 months for the family if the employee dies or gets divorced). This law applies to most employers of 20 or more people. The cost of the new policy is slightly higher than the cost of coverage under the group policy. A 1989 amendment provides additional help for dis- abled employees who leave their job. The 1996 Health Insurance Portability and Accountability Act (HIPAA) guarantees additional portability to individuals who have group coverage for at least 18 months before leaving a job. COBRA also gives a divorced, legally separated, or widowed spouse and dependent child the right to purchase coverage for 36 months.10
tYpes of plans
The approach to coverage insurance plans can be classi- fied into two main types: indemnity and managed care. (The word indemnity means “compensation for damage, loss, or injury.”) Indemnity insurance provides monetary benefits rather than services. It includes traditional fee- for-service plans and plans that pay fixed amounts per service, per day, or per week. Managed-care programs are responsible for delivering services in addition to funding them. They include HMOs, PPOs, and point of service (POS) plans. They are based on networks of providers who have contracted to provide services. Managed-care companies try to recruit providers who they believe will furnish cost-effective care. The dis- tinction between indemnity and managed-care plans is not clear-cut, however, because some plans contain features of both. The term “managed care” is also used to describe various procedures intended to reduce costs while pre- serving quality of care. These include requirements that nonemergency hospitalization, elective surgery, and
various other services be specially authorized in order to be covered. Managed-care companies may also in- spect the offices of providers, audit patient charts, issue guidelines, and provide financial incentives to providers who meet certain standards.
Individual vs. Group Plans Group insurance is offered through employers, labor unions, professional organizations, and other benevolent associations. Group health insurance has several advan- tages over individual insurance.11 Group policies usually offer greater benefits at lower premiums because econo- mies of scale make administration less expensive. Group insurance seldom requires evidence that individuals are insurable (have no serious pre-existing health problem) if they enroll when they become eligible for coverage. Much of the cost of group insurance may be borne by an employer. However, there is a trend toward shar- ing those costs by increasing deductible amounts and/or requiring employees to pay part of the annual premium.12
Employers who have more than 25 employees and of- fer health insurance may be required by federal law to offer membership in an HMO as an option. Some large groups offer employees a choice of fee-for-service or managed-care plans, either at initial enrollment or once a year. Some group plans offer dental as well as medical insurance. Some also offer long-term–care coverage, as an employee-paid option, for employees and their relatives.
Fee-for-Service Plans In fee-for-service plans, physicians, hospitals, and other providers bill the patient or insurance carrier for each service rendered. Fee-for-service policies include both group and individual plans, with premiums usually billed monthly or quarterly. The benefits received depend on (a) the deductible amount and whether it has been met; (b) the policy’s co-insurance provision, which typically is 20% of the covered amount until a specified amount has been reached; and (c) whether the policy pays UCR fees or follows a specific fee schedule. For benefits to be paid, claims must be filed by the insured individual or the provider.
Fixed-Dollar Plans Hospital indemnity plans pay fixed amounts of dollars during hospital confinement. They are typically sold by mail and through the Internet. Some policies specify coverage for such items as hospital room, surgery, or prescription drugs. For example, a hospital indemnity policy may pay $50, $75, $100, or more for each day a
Chapter Twenty-Three Health Insurance 475
patient is hospitalized. Because the average length of a hospital stay is about 5 days, and the average daily cost is more than $1800, such amounts will only cover a small percentage of the total cost. People who wish to increase their insurance coverage would be wiser to purchase a higher-limit policy or disability insurance. “Dread disease” policies cover treatment for cancer or other specified serious diseases. Although promoted as a way to supplement basic or major medical coverage, they are a very poor investment. Some of the benefits offered would duplicate existing coverage and thus are unnecessary. Other benefits typically are so narrowly defined that even if the dreaded illness occurs, the policy will cover only a small part of the cost. Moreover, the odds of developing a specific dread disease are small compared to the odds of becoming seriously ill from all causes added together. Therefore someone who wishes greater protection should purchase a high-limit compre- hensive policy that covers all illnesses rather than one or a few. A few states have banned or restricted the sale of policies limited to specific diseases. Consumers Union would like all hospital indemnity and dread disease poli- cies banned by federal law.
Discount Plans Discount plans purport to offer buyers an opportunity to get products and services at discount rates from partici- pating providers. The providers may include physicians, dentists, optometrists, and/or chiropractors, and some plans include drug discounts. These plans are inexpen- sive and entail no paperwork, but they are not actually insurance and provide little or no financial protection. Discount plans are often promoted with claims that are misleading or even fraudulent. One widely
advertised plan, for example, promised “afford- able care provided by 561,000 doctors, dentists, pharmacists, and hospitals,” but many who were listed on its Web site were not actually participants.13
Health Maintenance Organizations HMOs are health-care systems in which enrollees (or their employers) pay monthly or quarterly premiums that entitle them to treatment from designated provid- ers. In most cases, providers receive capitated payments or have another incentive to hold down costs. HMOs began operating in the 1930s, but they did not become a major factor in the marketplace until the 1973 Health Maintenance Organization Act allocated $375 million in seed money to start new ones. This law was passed with the hope that managed care would reduce national health expenditures. The law requires all employers with 25 or more employees to offer workers an opportunity to join a qualified HMO if one exists in the area. In 2009, about 75.3 million Americans were enrolled in 437 HMO plans.14
HMOs can be classified according to the way in which they are organized. There are five main types: oPen Panel model: An HMO contracts with an independent
practice association (IPA), a corporation that represents a group of providers with separate practices. The IPA pays the providers on a fee-for-service basis, typically at rates that are 15% or 20% less than the usual and customary fees. Patients see the providers in their individual offices. This model has the largest enrollment and number of plans.
grouP model: An HMO contracts with a single multispecialty group of physicians to provide health services to its mem- bers. A capitation payment is made to the group for each HMO member’s services regardless of the number of office visits made by members.
Managed Care ConsuMers’ bill of rights15
The Public Policy and Education Fund of New York, in cooperation with the Citizens Fund, has published a report stating that managed-care consumers should have the right to:
1. Timely access to appropriate health care. 2. Affordable choice of qualified health-care professionals. 3. Comprehensive health-care benefits that meet consumers’ health-care needs. 4. Receive health care that is affordable and free of financial barriers that impede access to health care. 5. High-quality health care. 6. Challenge decisions a plan makes about any practices or services that impact access to and quality of health
care. 7. Accurate, current, and understandable information about a managed-care plan. 8. Have medical information remain confidential and not be discriminated against in managed care. 9. Be represented in decision making and in the organization and regulation of managed care. 10. Vigorous enforcement of the Managed Care Consumers’ Bill of Rights.
Part Six Protection of the Consumer476
network model: An HMO contracts with two or more IPAs to provide services to its members.
staff model: This is the original model (used by Kaiser Per- manente), in which physicians are employed by the HMO and practice in a central office facility with administrative support. Doctors receive a salary and bonuses based on the HMO’s profits, costs of operation, physician performance, and other factors. Patients can select a primary care physi- cian who can direct them to staff specialists as needed.
direCt ContraCt: An HMO contracts directly with individual physicians.
Mixed-model plans use various combinations of these arrangements.
Preferred Provider Organizations PPOs combine features of HMOs and fee-for-service indemnity plans. PPOs contract with networks or panels of providers who agree to a negotiated fee schedule that usually is 15% to 20% lower than their standard fees. Subscribers can obtain services from any provider they wish and can see specialists without a referral from their primary care physician. However, they must pay a higher percentage of the cost if they use a nonparticipant. An exclusive provider organization (EPO) is a less expen- sive form of PPO that does not reimburse for the services of nonparticipating providers. In 2009 there were 476 operating PPOs covering 148 million eligible persons in the United States.14
Point of Service Plans POS plans are HMO/PPO hybrids. Subscribers choose a primary physician who provides basic care and can authorize referrals to specialists. As in HMOs, sub- scribers pay only their co-payments and deductibles for services rendered from participating providers, and they do not have to file claims. Subscribers who elect to see nonparticipating providers are reimbursed, but their out-of-pocket costs are significantly higher.
consumer-dIrected expense accounts
Three types of accounts can be used to help employees who are not covered by an ordinary health insurance plan: (1) flexible spending accounts (FSAs), (2) health reimbursement arrangements (HRAs), and (3) health savings accounts (HSAs). These plans are often de- scribed as “consumer-driven” because routine claims are paid from a consumer-controlled account rather than with a fixed insurance benefit. All result in tax benefits.16 FSAs pay for specified expenses as they occur. Authorized under section 125 of the Internal Revenue Code, they are also referred to as “cafeteria plans” or
“125 plans.” The employee contributes through a salary- reduction agreement and is reimbursed for medical and dental bills up to the total set aside. Up to $5000 can be contributed to an FSA each year. After March 15 of the following year, unspent funds are forfeited. Once the contribution amount has been designated during an an- nual open enrollment period, the employee is not allowed to change it or drop out of the plan without a change of family status. HRAs are employer-funded plans that are used to reimburse employees as expenses arise. At the end of each year, unspent funds can be rolled over for use in future years. HSAs are tax-exempt trusts or custodial accounts set up with a qualified trustee to pay or reimburse certain medical expenses. To be eligible, the employee must be covered by a high-deductible health plan. HSA contribu- tions are tax-deductible even if other deductions are not itemized on the employee’s federal income tax return. Contributions by employers (whether or not they are made through a cafeteria plan) are excluded from the employee’s gross income. The contributions remain in the individual account from year to year and can be invested until they are used. Money that remains at age 65 can be withdrawn as taxable income. HSAs are most suitable for (a) healthy people who must purchase their own insurance and (b) people who expect to have high medical expenses. However, prospective purchasers should carefully examine the fees involved in maintain- ing their trust account.
“concIerge medIcIne” Concierge medicine—also called boutique medicine—is a practice model in which the physician offers exclusive primary-care service to a limited number of patients for an annual fee. The typical practice includes house calls; 24-hour physician access by phone and electronic media; preventive care; same-day appointments; longer physicals and routine appointments; free check-ups; personalized wellness programs; and electronic medical records. In some plans, the doctor will accompany the patient to specialist appointments. Concierge physicians typically limit their practice to 600 patients and charge between $1500 and $1800 per year per patient, but annual fees can be as high as $20,000 for those who see fewer patients. The factors that affect the cost include the extent of the services, the patient’s age and health, and the number of participating family members. As the number of patients decreases, the level of attention and exclusivity of services tend to increase
Chapter Twenty-Three Health Insurance 477
along with the size of the annual retainer. In 2010, an estimated 5000 physicians had concierge practices.17 Critics charge that concierge practices will aggravate the problem of limited access to primary care. Propo- nents counter that by enabling physicians to have more time with patients to plan and prevent, money can be saved by reducing disease exacerbations and hospitaliza- tions, cutting physician overhead, eliminating wasteful duplication of services, and curbing insurance company profits. People contemplating enrollment in concierge prac- tice should carefully determine what is covered and what is not. Insurance will still be needed to cover hospitaliza- tions, various diagnostic procedures, and specialist costs.
IndemnItY vs managed care
Traditional (fee-for-service) indemnity plans tend to cost most, HMOs least, and PPOs and POS plans in be- tween. Managed-care plans also tend to result in fewer out-of-pocket costs, particularly for young adults and families with young children. However, the pattern is not consistent. Some indemnity and PPO plans are less expensive than HMOs. Surveys have found that higher-
priced plans tend to be rated higher by their subscribers, but some lower-priced plans also have been rated highly. Traditional indemnity policies tend to involve more paperwork (in filing claims) but provide greater choice of providers, which may be important for people who are chronically or seriously ill. Table 23-3 provides ad- ditional comparative data. People inclined toward managed care should care- fully investigate whether a suitable primary physician is available to them in any plan they consider. Other favorable signs are affiliation with an accredited teaching hospital, access to enough specialists, and a high percent- age of board certification among its physicians. Some HMOs provide data on subscriber satisfaction with their primary care physicians. State insurance departments can tell whether complaints have been made about specific plans. Accreditation provides a useful guideline for judging the quality of a managed-care plan. The National Com- mittee on Quality Assurance (NCQA) is an independent, nonprofit organization that evaluates health plans and providers. Its standards cover access and service, pro- vider qualifications, health maintenance strategies, and quality of care. NCQA operates the Health Employer
Characteristic
Are consumers free to choose provid- ers?
Are providers free to prescribe treatment?
Does insurer bear financial risk?
Do providers share financial risk with insurer?
Is insurer obliged to provide health- care services?
Must consumer file claim forms?
Relative cost of premiums
Relative out-of- pocket expense
comparIson of Insurance plans
Table 23-3
Fee-for-Service
Yes
Yes, if medically necessary and appropriate
Yes
No
No
Yes, unless provider does
Tends to be highest
Lower-cost policies have highest out- of-pocket expense
PPO
PPO providers can be seen at discounted fees. Out-of-plan providers can be seen but cost more
Yes, if medically necessary and appropriate
Yes
Rarely
Yes, within provider network
Only for out-of-net- work services
Between fee-for-ser- vice and HMO
Low if out-of- network services are not used
POS
Coverage provided for provid- ers in plan. Other providers paid according to fee sched- ule; consumer must pay any additional cost
Some restrictions; preapproval is sometimes needed
Yes
Sometimes
Yes, within provider network
Only for out-of-network services
Between fee-for-service and HMO
Low if out-of-network services are not used
HMO
Coverage provided only for providers in plan
Some providers use physician assistants for screening
Many services must be preapproved in order to be covered
Yes
Yes; penalties or incentives discourage use of “un- necessary” services
Fully responsible for neces- sary and appropriate services
No
Tends to be lowest
Tends to be lowest
Part Six Protection of the Consumer478
Data Information System (HEDIS), a “report card” in- tended to enable employers and consumers to compare plans. The NCQA also publishes an accreditation status list and “report card” for individual plans. (See http:// reportcard.ncqa.org.) In August 2011, its database listed more than 700 health plans as accredited.18
Among 37,481 Consumer Reports readers who responded to a 2008 survey, 64% said they were very or completely satisfied with their plan, 18% said they had trouble seeing their plan doctor at least once during the previous year, and among users of some lower-rated plans, as many as 16% complained that it was difficult or impossible to get needed care. The survey also found that people in PPOs encountered more hassles and billing errors than those in HMOs.19 The Center for the Study of Services20 has noted that “even if you prefer one plan type in theory, you might choose another type because that specific plan is extraordinary.”
loss ratIos
The amount of money a company pays out in claims can be expressed as the benefit-cost ratio or loss ratio. This is calculated by dividing the amount paid in benefits by the amount received in premiums. A high loss ratio is a favorable sign. A low loss ratio indicates that a company is either inefficient or is making excess profits. America’s Health Insurance Plans (AHIP)21 reports that the national average loss ratio for commercial plans is 88%, with the largest groups averaging 93% and the smallest groups averaging 70%. The PPACA requires health plans to provide rebates to consumers if their loss ratios are lower than 80% for individual and small-group coverage, or 85% for large-group coverage. Data on individual companies are compiled by state insurance departments and are also published by A.M. Best in manuals available at many public libraries. However, loss ratios vary not only from company to company but from one type of policy to another within a company. Data on specific policies may be available from company representatives or agents.
cHoosIng a plan
Choosing health insurance can be complicated. There are many types of plans, and contracts can vary greatly from company to company and even within the same company. Colleges typically provide outpatient health services through a student health service, usually at a low fee that
is paid along with tuition. Some also require students to purchase additional insurance to cover hospitalization or other outside services. Students covered under their family’s policy may not be required to purchase addi- tional insurance. It is usually most economical to remain covered under a family policy as long as possible rather than obtaining a separate policy. After college it is usually best to see whether group coverage is available through work or membership in an organization. If you work for a large company, several plans may be available and the human resources depart- ment should provide literature and may be able to help you choose. If no group coverage is available, contact several other insurance companies, including some that provide managed-care plans. You should also investi- gate whether a “consumer driven” health plan would be practical for you. If you find it difficult to obtain insurance because of a pre-existing health problem, find out from your state insurance department or a broker whether your state has a risk pool similar to the assigned-risk pools for automobile insurance. After considering your needs, obtain both a summary and a copy of each policy that sounds suitable, read them carefully, and be sure you understand what they say. If you want both basic and major medical coverage, they should be obtained from the same company to avoid gaps in coverage. Your aim should be to insure mainly against the most serious types of losses. In the long run, it is more economical to absorb the cost of minor medical expenses as part of your overall budget. Policies that pay a fixed daily amount or overlap your essential coverage should be avoided. Consumer Reports22 recommends (a) looking for a policy that picks up 100% of medical expenses when they hit a certain level in a year—perhaps $5000 or $10,000, and (b) choosing a higher deductible and/or higher out-of-pocket limit rather than any “fixed dollar” limit for potentially very expensive services. Table 23-4 can help you compare plans. Some state insurance departments can provide information on com- plaints made against health insurance companies. Health- care.gov has information about many insurers and has online tools to help compare features. The Georgetown University Policy Institute (www.healthinsuranceinfo. net) publishes excellent state-by-state consumer guides. The Weiss Ratings Web site (www.weissratings.com) ranks the financial stability of hundreds of plans. The “Scam Alert” Consumer Tip box on page 480 describes common signs of fraudulent promotions.
Chapter Twenty-Three Health Insurance 479
Type of policy • Is the policy a group or individual one? • Is the insurance comprehensive, providing basic health
insurance that includes hospital, surgical, medical, and (if needed) maternity benefits? Does it also in- clude major medical provisions, or is such insurance available?
Hospital coverage • How many days are covered for each illness? What is the per diem rate? Is the allowance sufficient to cover the entire daily rate? Is there coverage for intensive care?
• What services are covered? • Is there a deductible clause? • Is the choice of hospitals limited? • Are in-hospital physicians’ services covered? • Is consultation permissible? Under what conditions? • Are the covered days limited to one period of hospi-
talization, or is there more than one period covered up to a maximum number of days?
• Are there limitations on readmission to a hospital for the same illness?
Surgical coverage • What surgical procedures are covered, and to what
extent? What is the surgical fee schedule? • Are there provisions for consultant services? • Are second opinions required? If requested by the
subscriber, are they covered? • Are there limits in the choice of surgeons? • How do the fees allowed compare to what local sur-
geons charge?
Medical coverage • Which services are covered? Excluded? Limited? • Are home and office visits covered? Are there any
limitations? • Is there a deductible clause? • Does it include service for accidents? • Is the choice of physicians limited? • Are periodic well-person physical examinations, pre-
ventive immunizations, Pap tests, and other preventive measures covered?
• Are prescription drugs covered? • Is treatment for mental and emotional problems and drug and alcohol abuse covered? To what extent?
• Are there provisions for concurrent services of more than one physician when medically necessary?
QuestIons to ask WHen comparIng HealtH Insurance polIcIes
Table 23-4
When choosing health insurance, become familiar with all the literature provided. It is best to obtain a copy of the policy and read it carefully. If the language appears conflicting or difficult to understand, ask the company representative for clarification. Be sure the coverage is suitable, and don’t hesitate to shop around. Coverage and costs vary greatly from plan to plan. The following questions can help you to compare plans.
Maternity care • What expenses are covered? What are the limita-
tions? • What complications are covered? • What is the waiting period?
Major medical insurance • What services are covered? • What is the maximum coverage? The minimum recom-
mended is $1 million. What is the stop-loss limit (the amount over which the company pays 100%)?
• Is there a deductible? How much? • Is co-insurance required? Limits? • Can maximum limits be restored after illness? • What percentage above the deductible is paid by the
company?
Nursing home or home care • What services are covered? For how many days? At what daily rate?
• Is prior hospitalization required for coverage? • Are services of RNs, LVNs, LPNs, or other allied
health professionals covered? • Are medications and medical supplies covered?
Contract provisions • Are all family members covered? To what ages? • Are there waiting periods? What is the effective policy
date? • What are the conditions and limitations for pre-existing conditions? Do they apply for more than 1 year?
• Can the policy be converted to an individual plan? To a family plan if an individual marries? Is it convertible after retirement?
• What are the conditions regarding cancellation and re- newal of policy? By whom? Is renewal guaranteed?
• What are the exclusions? Are they more restrictive than the usual ones, such as dental, vision, hearing?
• Does coverage include out-of-area services, and ser- vices in foreign countries?
• Can rates be changed? What are the conditions under which rates may be changed?
Selecting an insuring organization • Is the company licensed in your state? • Is the company or agent reliable and reputable? • How is it rated by Weiss Ratings Guide? • Does the company have a reputation for paying promptly and without hassles?
• What is the loss ratio? Is it at least 80%?
Part Six Protection of the Consumer480
medIcare
Medicare is a federal insurance program created by amendments to the Social Security Act. It provides ben- efits for people age 65 years or older, people under 65 with certain disabilities, and people of all ages with kid- ney failure who require dialysis or a kidney transplant. It is administered by the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. Various commercial insur- ance companies are under contract with CMS to process and pay Medicare claims, and groups of doctors and other health-care professionals have contracts to monitor the quality of care given to Medicare beneficiaries. All plans that contract with Medicare must have an open enrollment period of at least 30 days per year.23 People who believe that a Medicare payment is too low have the right to appeal for reconsideration. Ad- ditional details about Medicare coverage are published in Your Medicare Benefits,24 a handbook that is updated annually and is available online at www.medicare.gov or from the Medicare hotline (800-638-6833).
Original Medicare Plans “Original Medicare” has two parts. Part A helps pay for inpatient hospital care, inpatient care in a skilled nursing facility, and hospice care. Part B helps pay for doctors’ services, outpatient hospital services, laboratory services, ambulance service, durable medical equipment, and various other medical services and supplies. Part A is financed by Social Security taxes. Employers and employees now pay 1.45%, and the self-employed pay 2.9% on all earnings. Part B subscribers pay monthly premiums that cover about 25% of the government’s cost of running the program. The premium is either billed quarterly or deducted from the insured person’s Social Security check. Most people older than 65 are eligible for Part A. There is no monthly charge, but eligible individuals must request coverage. When signing up, they are auto- matically enrolled in Part B but can opt out when their Medicare card arrives. Those who opt out can re-enroll during the first quarter of the following year at a higher premium. People planning to begin Medicare coverage at age 65 should contact their local Social Security office 3 months beforehand to obtain the enrollment forms. Medigap insurance, also called supplemental in- surance, is available in standard packages that must supplement Part A so that the beneficiary is covered for hospital co-insurance and 365 additional lifetime hospi- tal days after the Medicare hospital benefit is exhausted.
The price of the policy reflects the number of additional benefits (such as skilled nursing co-insurance, prescrip- tion drugs, the Part B deductible, and certain preventive care services) that are included.26 The best time to pur- chase a Medigap policy is during the open enrollment period, which is 6 months from the date of Medicare Part B enrollment (after age 65). During this period, no applicant can be refused. After it ends, companies have the right to restrict which policy they sell and to refuse coverage entirely. State insurance commissioners can provide information on the types of policies approved for sale within their state.
Medicare Advantage Plans Medicare Advantage, also called Medicare Part C, is offered and administered by private companies ap- proved by Medicare. Medicare Advantage plans must encompass parts A and B and may offer extra coverage, such as vision, hearing, dental, and/or health and well- ness programs. The monthly fee, deductibles, and co- payments vary from one plan to another. The monthly premiums for Medical Advantage plans tend to be lower than those of Medigap policies—and some charge no premium—but they limit the choice of providers and have other restrictions.
Prescription Drug Plans Medicare Part D partly covers prescription drug costs. Most Medicare Advantage Plans include it, but it is also available separately. An interactive tool on the official Medicare Web site (www.medicare.gov) can help deter- mine whether a Part D plan is worthwhile.
√ Consumer Tip
Scam Alert Kirschheimer25 warns against insurance promotions that involve any of the following:
• Coverage that promises full benefits but costs much less than similar policies.
• “Easy sign-up” for an individual (not group) policy regardless of preexisting conditions and with no required medical exams or questionnaires.
• Offers to have an agent visit your home rather than mail you information about coverage and costs.
• Any attempt to get your Social Security number and bank account during a sales presentation.
• A pitch that mentions “coverage,” “benefits,” and “health protection”—but not insurance.
Chapter Twenty-Three Health Insurance 481
Fee Limitations The 1989 federal Physicians Payment Reform Act limits the amount that doctors who do not accept Medicare’s assigned fees are permitted to charge patients older than 65. The current limit is 15% above what Medicare pays. The law requires physicians to file claims for all reim- bursable services. The law also states that if Medicare denies payment for services (as not reasonable or nec- essary), the physician may not collect from the patient unless the patient was notified in advance or should have known that the services were not reimbursable. (In many cases the patient will be asked to sign an advance notice.) The 1989 law does not limit hospital outpatient charges. This means that Medicare patients who are responsible for 20% of the charges can have sizable out-of-pocket expenses for hospital outpatient services.27
medIcaId
Medicaid (also called Medical Assistance) is a federal grant-in-aid program under which the states may con- tract with the Secretary of Health and Human Services to finance health-care services for public assistance recipients. California’s program is called Medi-Cal. These programs provide comprehensive care and nurs- ing home coverage for certain categories of indigent and medically indigent persons.28 There are about 52 million eligible persons, including the aged, blind, disabled, and members of single-parent families with dependent children. The proportion of state-to-federal funding of the program is determined by a formula based on each state’s per capita income. Eligibility requirements differ from state to state but generally require a low income and few assets. Some people establish eligibility by incur- ring medical expenses until their assets are depleted and their net income after medical expenses is low enough to qualify. Of those eligible for Medicaid, nearly half are eligible to receive Medicare. PPACA calls for increased services and eligibility starting in 2013.
otHer government-sponsored programs
Several other federally sponsored programs offer care to millions of Americans. Details of their offerings are fully described on their Web sites. The Veterans Health Administration (www.va.gov/ health) is a large network of clinics and hospitals that serve veterans who served on active military duty and various other people who provided military-related ser- vices. The families of veterans may be eligible for care through CHAMPVA (www.va.gov/hac/forbeneficiaries/ champva/champva.asp).
The Military Health System (www.health.mil) provides hospital and outpatient care to members of the armed forces and their families. It includes TRICARE (www.tricare.osd.mil), which covers military retirees, their dependents, and dependents of active duty per- sonnel. TRICARE also serves members of the National Guard and Reserves and their families, but its benefits vary depending on the sponsor’s military status. The Indian Health Service (www.ihs.gov) provides comprehensive health services to about 1.9 million American Indian and Alaskan Native people who belong to federally recognized tribes in 35 states. The Children’s Health Insurance Program (CHIP) (www.cms.gov/home/chip.asp) is a federally subdized program that provides free or low-cost medical, den- tal, and hospital services up to age 19 for children of uninsured families that do not qualify for Medicaid. Eligibility and fees depend on the age of the child and the family’s size and gross income. The Program of All-Inclusive Care for the Elderly (PACE) (www.cms.hhs.gov/pace) is a capitated HMO for persons age 55 or older who are certified as eligible for nursing care.
long-term–care Insurance
Long-term care refers to the nursing, medical, and so- cial services provided to an individual over a prolonged period (see Chapter 22). The most common settings are nursing homes and individual homes. The levels of service provided in nursing homes are classified as skilled nursing care (intensive medical and rehabilitative care by trained personnel), intermediate nursing care (less intensive care by trained personnel), and custodial care (daily activities such as meals, bath- ing, and dressing). In home care, patients may receive skilled nursing care (also occupational and physical therapy), home health aide services (personal and custo- dial care), and homemaker services (cleaning, cooking, and running errands). In 2002 Spillman and Lubitz29 estimated that 46% of Americans who were 65 would enter a nursing home some time before they die and that 55% of these would spend at least 1 year there and 19% would stay for more than 5 years. The Genworth 2011 Cost of Care Survey30 found that the median annual cost of a semiprivate room in a nursing home was $70,445 ($193/day) and that home care averaged $18 per hour. The premiums for long-term–care insurance de- pend on the age of the person, daily benefit levels, how long benefits are paid, and length of elimination period (number of days or home visits before coverage begins).
Part Six Protection of the Consumer482
Most policies require passage of a period of time before covering the treatment of pre-existing conditions. The cost can be reduced by selecting a policy with a long waiting period (such as 100 days) or a shorter benefit period (3 or 4 years rather than lifetime benefits). Policies with benefits that increase with inflation cost about 40% more than those that provide a fixed monthly amount. Eligibility for benefits is based on the severity of impair- ment and the inability to perform a certain number of activities of daily living. In 1996, HIPPA made premiums for long-term–care insurance deductible as a medical expense for income tax purposes. People whose income and assets are low enough or nearly low enough to qualify for Medicaid cannot afford to purchase long-term–care insurance. To encourage the purchase of long-term–care insurance, most states have established Long-Term Care Partnership Programs that enable purchasers to retain assets equal to the amount spent on their premiums if their policy benefits run out.31
At age 55, a typical individual non-Partnership policy offering two years of coverage, a 100-day elimination period, at a benefit level of $200 per day for nursing home, assisted living, and home care, five different policies are offered by three companies and the premiums range from $720 to $1268 per year without inflation protection and from $1723 to $3063 per year with inflation protection. For the same policy purchased at age 65, the premiums range from $1581 to $2767 per year without inflation protection and from $2874 to $5049 per year with inflation protection.32
Long-term care insurance is most suitable for indi- viduals with assets between $200,000 and $1 million (in addition to their home) who can afford to spend up to 7% of their income to purchase the insurance. Consumers investigating long-term–care insurance should examine sample copies as well as outlines of the policies and should obtain answers to these questions:
• Does the policy cover skilled nursing, intermediate care, and custodial care, at a nursing home, other assisted living facilities, and at home? What services are covered?
• What is the daily benefit? It should pay half to two-thirds of the cost. Will benefits increase with inflation?
• How long will the benefits last? • When do benefits begin? (The longer the elimination period,
the less costly the policy.) • Under what circumstances can the premiums increase? • Is payment of further premiums waived if the insured person
stays in a nursing home? • Do benefits hinge on prior hospitalization? (Nearly two- thirds of the patients who enter a nursing home have not been hospitalized beforehand.)
• Is Alzheimer’s disease covered? To what extent? Is any other illness or injury excluded from coverage?
• What are the restrictions on pre-existing conditions? Wait- ing periods? Deductible?
• Are there any other limitations or exclusions? • Are policies guaranteed renewable? • Is the company’s loss ratio 80% or higher? • Is the company’s financial strength rated “B” or better by
Weiss Ratings’ health insurance and HMO/PPO guides. Consumer guides to long-term–care insurance are available online from America’s Health Insurance Plans (www.hiaa.org) and many state agencies.
dental Insurance
Dental insurance programs were started by nonprofit dental service corporations sponsored by local den- tal societies. Nearly all private plans are group plans sponsored by employers or labor unions. Medicaid also provides coverage in some states. The most common plans can be grouped into three categories:
direCt reimbursement Programs reimburse a percentage of the dollar amount spent and provide free choice of dentist.
Preferred Provider organization (PPo) programs are plans in which contracting dentists agree to discount their fees as a financial incentive for patients to select their practices. In some plans, patients who choose a nonparticipating dentist will have benefits reduced or withdrawn completely.
dental health maintenanCe organization/CaPitation Plans pay contracting dentists a fixed amount (usually monthly) per enrolled family or individual. In return, the dentist agrees to provide specific types of treatment at no charge or with a co-payment.
About half of Americans older than 2 have dental insurance coverage. This usually covers examinations, fillings, x-ray films, extractions, cleaning, and dentures. Orthodontic and endodontic care, bridgework, oral surgery, and periodontics are often limited or excluded unless a higher premium is paid. Other common exclu- sions or limitations apply to pre-existing conditions, replacement of lost dentures, dentures and bridgework to replace teeth lost prior to coverage, and expenses covered by other insurance. In 2008, the National Association of Dental Plans reported that monthly premiums for individual coverage averaged about $170/year for HMO plans and $524/year for PPO plans and that family plans averaged $488/year for HMO plans and $1532/year for PPO plans. Individual plans, purchasable directly from an insurance company, have higher premiums, more limited coverage, and larger out-of-pocket expenses. Dental costs that can be covered by insurance are much more predictable than medical costs and can fit within most budgets. People whose teeth and gums are healthy do not need dental insurance if the annual cost of
Chapter Twenty-Three Health Insurance 483
dental checkups and cleaning will be less than the cost of dental insurance. People who expect to need more care should compare their anticipated expenses with the cost of insurance premiums.
collectIon of Insurance BenefIts
When a policy is issued, covered individuals will be issued a card indicating the name of the company, the group and policy number, and the type of plan. Providers generally ask new patients to complete a registration form that includes basic information (name, address, and age), current problem, past medical history, medications taken, and insurance information. The insur- ance card will also be requested and a copy made. For HMOs, a plastic card may be used to fill out encounter and referral forms. After the service is completed, the patient will be given a charge slip or a receipt. If the patient has insur- ance, that form can be submitted to the insurance com- pany by either the patient or the provider. For Medicare, the provider must submit the bill. Figure 23-1 shows the HCFA 1500 claim form re- quired by Medicare but used by many other companies. Forms completed with a computer or typewriter can be processed by scanning, which may result in earlier payment. Many providers submit the data electronically, which makes processing even more efficient.
The patient (or other responsible party) will usually be asked to sign the claim form. If payment is not made at the time of the visit, the patient will usually be asked to assign payment to the doctor, either by indicating this on the claim form or by signing a separate statement. When this is done, payment is made directly to the provider. Hospitals and most other providers routinely file claims for basic insurance coverage either electronically or by filling out forms. If not, the patient is responsible for the filing. For reimbursement under major medical policies, the insured files the claims. Physicians often elect to accept what insurance pays in return for a guarantee that payment will be made di- rectly to them rather than to the patient. This procedure is known as accepting assignment. When a physician accepts assignment, the patient may not be billed for the difference between the provider’s charge fee and the amount paid by the insurance company (except for amounts that involve deductibles or co-insurance). Pro- viders are likely to accept assignment when patients have financial difficulties or when the physicians think that a patient might pocket a direct insurance payment without paying the medical bill. If the provider does not belong to a fixed-fee plan and has not accepted assignment, the patient will be liable for the difference between the physician’s fee and the policy allowance. Patients who belong to an HMO are responsible only for co-payment (usually $10 to $25 per office visit) for covered services, plus any fees for noncovered services. Since 1989 physicians have been required to submit appropriate codes when billing for services to Medi- care recipients. The diagnosis codes are listed in the International Classification of Diseases, Tenth Edition, Clinical Modification (ICD-10-CM), which is available from several publishers. Most insurance companies have the same requirement. Procedure codes have been stan- dardized in Current Procedural Terminology, which is updated annually by the American Medical Association and incorporated into manuals published by the AMA, insurance companies, and commercial publishers. These codes are usually referred to as “CPT codes.” The codes for medical evaluation and management are based on the complexity of the service and whether the patient has been seen previously. Some insurance companies ask providers to submit a descriptive phrase in addition to the CPT code. In 1992 Medicare implemented the resource-based relative value system, a method of payment quite dif- ferent from the UCR method. The system is intended to help control costs and to provide more equitable reim- bursement for services rendered. Under this system:fIgure 23-1. HCFA 1500 insurance claim form.
Part Six Protection of the Consumer484
• Payment is made according to the resource-based relative value scale (RBRVS), a nationwide fee scale that takes into account (a) the extent of history taking and physi- cian examination, (b) the complexity of medical decision making, (c) the time spent counseling the patient, (d) the severity of the patient’s health problem, and (e) the time spent with the patient.
• Fees that Medicare patients can be charged by doctors who do not accept assignment cannot exceed Medicare- approved fees by more than 15%.
• Doctors are prohibited from offsetting fee reductions by ordering more tests, doing more procedures, or submitting a higher proportion of claims for higher-priced services.
• Restrictions were placed on referral of patients to clinical laboratories or other health-care facilities in which the referring physician has a financial interest.
Table 23-5 illustrates how the severity and com- plexity of the problem are related to the level of care for which physicians are permitted to bill Medicare. Virtually all health insurance companies now use the RBRVS coding system. After receiving the claim, the insurer determines what the provider and patient should be paid. Payment is accompanied by an Explanation of Benefits (EOB) statement that itemizes the services, indicates what is covered, and explains whatever amounts are not paid. Figure 23-2 illustrates a sample report. Health insurance companies process billions of claims each year, and errors and delays do occur. These suggestions may help you obtain the benefits to which you are entitled:
• Know and follow your plan’s rules. • Keep careful records of all health-related bills. • Be sure that claim forms are filled out accurately and com-
pletely. Keep a photocopy for reference. • If asked for documentation, send photocopies. Never send
your only copy of a bill to an insurance company. • Check that EOB forms have your correct name, address,
group number, and dates and types of service. • If a problem arises, contact the company for an explanation
or to register a complaint. The contact can be by telephone or mail. If you phone and the person to whom you speak cannot resolve the problem, ask to speak with a supervisor.
• If that does not resolve the problem, write to the company president or the state insurance department. Some states have programs in which medical necessity denials can be reevaluated by an independent medical reviewer.
dIsaBIlItY Insurance
Disability insurance provides income when sickness or injury interferes with ability to earn a living. It is avail- able through employer-paid and government-sponsored programs. Individuals can also purchase private policies, but these tend to be much more expensive. Policies vary in terms of eligibility requirements, premiums charged, disability definition, extent of benefits, waiting periods before benefits begin, length of coverage (short-term or long-term), protection against inflation, coverage of office overhead, and other features. Employees are also covered in every state through a workers’ compensation program for job-related injury and (when they have
You will soon have the opportunity to select a health insurance plan for yourself or your family from several offered by your employer. Which of the following actions would you take?
Ask a friend, neighbor, or relative for advice _______________________ Select an HMO or PPO policy _______________________ Select a fee-for-service policy _______________________ Try to determine your health insurance needs _______________________ Obtain sample policies for review _______________________ Compare sample policies using a list of guidelines _______________________ Ask your family doctor for assistance _______________________ Other: (specify) ______________________ _______________________
In considering policies, which things are most important to you?
The amount of the premium _______________________ The freedom to choose whichever doctors you want _______________________ The size of the deductible or co-payments _______________________ The company’s reputation _______________________ Other factors (specify)______________________ _______________________
It’s Your Decision
Reason
Chapter Twenty-Three Health Insurance 485
Examination
Focused on one problem
Expanded problem-focused Detailed
Comprehensive
Comprehensive
Minimal, if any
Expanded problem-focused
Detailed Comprehensive
Comprehensive
CPT Code
99201
99202
99203
99204
99205
99211
99212
99213
99214
99215
cpt code guIdelInes for outpatIent medIcal care of neW and estaBlIsHed patIents
Table 23–5
*All three of these components are required for the first visit. For subsequent visits, only two are required.
Typical Time with Patient
10 minutes
20 minutes
30 minutes
45 minutes
60 minutes
5 minutes; doctor not required 10 minutes
15 minutes
25 minutes
40 minutes
Typical Examples of Problems or Professional Services
Baby with diaper rash Skin bump requiring no treatment Adolescent with acne College student with seasonal allergies Vasectomy counseling Knee injured during football game Chest pain on exertion, 63-year-old man Multiple joint pains, 70-year-old woman Unexplained 15-pound weight loss Evaluation and counseling, suicidal patient
Blood pressure check Changing a dressing
Student with sore throat, fever, and fatigue Child with sore throat and headache
Diabetic needing to change insulin dosage Quarterly follow-up visit for asthmatic Recent heart attack patient with intolerable side effects from a medication Elderly patient with recent onset of fainting Discussion of treatment options with patient recently diagnosed with colon cancer
First visit (new patient)
Subsequent visits (established patient)
Typical Severity
Self- limited Low to moderate Moderate
Moderate to high High
Minimal
Self- limited or minor Low to moderate Moderate to high High
Complexity
Straight- forward
Straight- forward Low
Moderate
High
Low
Straight- forward
Low
Moderate
High
Extent of History
Problem-focused
Expanded Detailed
Comprehensive
Comprehensive
Problem-focused
Expanded
Detailed
Comprehensive
Comprehensive
Key Components*
explanation of benefits stateMent
11/18/10 VISIT 99213 43.00 .00 43.00 5.00 80 30.40 11/18/10 ECG 93000 40.00 5.00 A1 35.00 0.00 100 35.00 11/29/10 SURG 11200 30.00 30.00 D7 0.00 0.00 0 0.00
113.00 35.00 78.00 5.00 65.40
COLLEGE, JOEL 200 CAMPUS DRIVE ANYTOWN, US 90000
COLLEGE,JOEL 999-99-0001 COLLEGE,JOEL
MeMber s.s. no. patient
1/17/11 123454321
date ClaiM no.
Date(s) of Service
Description of Service
Provider’s Charge
Excluded Amount Code
Covered Charge Deductible %
Benefit Amount
totals
fIgure 23-2. Portion of sample EOB statement. The insurance policy covered 80% of medically necessary office visits and 100% of procedures but had a co-pay of $5 per visit. On November 18th the insured had an office visit and an electrocardiogram (ECG). Nothing was excluded from the office visit fee because it was in line with the company’s UCR fee allowance. After deducting the $5 co-payment, the company paid 80% of what was left. The doctor charged $5 more than the company paid for ECGs. (“Code A1” indicated that the provider’s fee exceeded the company’s UCR fee.) Since the doctor had agreed to accept the company’s allowable fees, the patient did not have to pay the $5. The operation on November 29 was removal of two skin tags (little outgrowths of skin) of the neck, which the patient wanted removed because they interfered with shaving. (“Code D7” indicated that the procedure was not covered because it was not medically necessary.)
Part Six Protection of the Consumer486
worked long enough) through Social Security for long- term disability from any cause. Before buying a disability policy it is wise to assess whether coverage already ex- ists, what additional coverage would be needed to meet expenses, and how soon benefits would be needed.
summarY
Health insurance enables people to budget in advance for health care. It is important for nearly everyone because medical and hospital care can be extremely expensive. A health insurance policy is a business agreement formal- ized by a written contract that details both benefits and obligations. Basic health insurance includes benefits for hospital, surgical, and medical expenses. The extent of these benefits differs from contract to contract. Major medical contracts take over where basic insurance plans leave off. Managed-care policies combine insurance with health-delivery systems. Group policies generally offer more coverage and cost less than individual policies. Most people are in- sured through a group policy obtained through their place of employment. Because the extent and type of covered services vary widely from contract to contract, policies should be read carefully to understand what protection they provide. Managed-care plans tend to have lower premiums and result in fewer out-of-pocket costs. Fee- for-service plans tend to cost more and involve more paperwork (in filing claims) but provide greater choice of providers. Consumer-directed expense accounts offer tax savings to eligible persons. Many people meet eli- gibility requirements for government-sponsored health insurance programs. Long-term–care, dental care, and disability are not normally covered by health insurance. Decisions about coverage for these concerns can be challenging. To get the full benefit of a health plan, it is important to understand the extent of coverage and any procedures (such as preauthorization) required when seeking care and to be assertive when necessary. The Patient Protec- tion and Affordable Care Act will change the insurance landscape significantly.
references
1. Cohen P. Health plan roulette. In Health 4(4):78–82, 1990. 2. Clinton HR. Foreword to White House Domestic Policy Council.
Health Security: The President’s Report on the American People. Washington, D.C., 1993, U.S. Government Printing Office.
3. Hospital adjusted expenses per inpatient day, 2009. Kaiser Health Foundation, statehealthfacts.org, accessed Sept 2011.
4. Source Book of Health Insurance Data, 1999–2000. Washington, D.C., 1999, Health Insurance Association of America.
5. Statistical Abstract of the United States: 2011. Washington, D.C., U.S. Census Bureau, 2010, Table 151. 1.
6. Frequently asked questions about newborns’ and mothers’ health protection. U.S. Department of Labor, Employee Benefits Security Administration Web site, accessed Aug 2, 2005.
7. The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). CMS fact sheet, Jan, 2010.
8. Pre-Existing Condition Insurance Plan. HealthCare.gov Web site, accessed Sept 6, 2011.
9. Major provisions of the Affordable Health Act. Commonwealth Foundation Web site, accessed Aug 20, 2011.
10. Employer’s guide to group health continuation coverage under COBRA: The Consolidated Omnibus Reconciliation Act of 1986. Washington, D.C., 2005, US Department of Labor.
11. Gabel J and others. Individual insurance: How much financial protection does it provide? Health Affairs Web Exclusive, April 17, 2005.
12. Employer Health Benefits: 2010 Annual Survey. Kaiser Family Foundation (Menlo Park, Calif) and Health Research Educa- tional Trust (Chicago), 2010.
13. Vaden T. ‘Free health card’ is confusing. Raleigh News & Observer, Nov 23, 2008.
14. HMO-PPO Digest. Bridgewater, N.J., 2010, Aventis Pharma- ceuticals.
15. Finkelstein R, Hurwit C, Kirsch R. The Managed Care Consum- ers’ Bill of Rights. New York, 1995, Public Policy and Education Fund of New York.
16. Health savings accounts and other tax-favored health plans. IRS Publication 969, 2010.
17. Clark PA and others. Concierge medicine: Medical, legal and ethical perspectives. The Internet Journal of Law, Healthcare and Ethics. Volume 1, 2011.
18. NCQA’s health plan report card. NCQA Web site, accessed July 15, 2005.
19. Best health plans: 37,481 readers show you how to make the right choice. Consumer Reports Web site, Sept 2009.
20. Consumers’ Guide to Health Plans. Washington, D.C., 2002, Center for the Study of Services.
21. The federal medical loss ratio (MLR) calculations—Background and initial costs of compliance. America’s Health Insurance Plans, Center for Policy Research, June 2011.
22. If you buy health insurance on your own. Consumer Reports Web site, Oct 2010.
23. Understanding Medicare enrollment periods. Center for Medi- care Services tip sheet, Feb 2011.
24. Your Medicare Benefits. Baltimore, 2011, Centers for Medicare & Medicaid Services.
25. Kirschheimer S. When health insurance is phony. AARP Bul- letin, Dec 2009, p 31.
26. Choosing a Medigap Policy: A Guide to Health Insurance for People with Medicare. Baltimore, 2011, Centers for Medicare & Medicaid Services.
27. McLeod D. Medicare outpatient debacle: Hospitals allowed to charge more for outpatient care. AARP 37(8):4, 1996.
28. Flowers L. The Medicaid program: A brief overview. AARP Public Policy Institute fact sheet, Feb 2005.
29. Spillman BC, Lubitz J. New estimates of lifetime nursing home use: Have patterns of use changed? Medical Care 40:965–975, 2002.
30. Genworth 2011 Cost of Care Survey. Waltham, Mass., 2011, Genworth Financial.
31. Long Term Care Partnership Only Web site, accessed Aug 22, 2011. 32. Guide to long-term care insurance. Washington, D.C., 2004,
America’s Health Insurance Plans.
HealtH-Care FinanCing
The American health care system, and especially its cost, is out of control, inhibiting access to care for many, lessening quality of care for some, and creating an almost palpable angst among physicians and others concerned with this enormous national problem.
Nicholas E. DaviEs, M.D.1
louis h. FElDEr, M.D.
Imagine if all doctors and all hospitals in the US had just one type of form to fill out. And all patients had one insurance card. And all patients had health insurance. . . . And now think of the savings in time, money, paper-pushing. Doctors would have more time to care for patients; everyone would have fewer headaches waiting to talk to their HMO to prove their coverage; nurses would be less frustrated with their work.
GraMazoN.coM2
The only plausible explanation for the US paradox of spending more and getting less is that the US health care system is enormously inefficient.
Marsha aNGEll, M.D.3
© m
ed ic
al ec
on om
ic s,
19 95
“Is there a doctor in the house affiliated with the Apex HMO?”
Chapter Twenty-Four
Part Six Protection of the Consumer488
Skyrocketing costs and inequalities in the distri- bution of services are persistent problems in the U.S. health-care system. Part of the problem is
the high cost of new technology. But many critics of our health-care system describe it as choked by paperwork, strangled by bureaucracy, and riddled with waste and inefficiency. Solutions to these problems have been stymied by their complexity and the competing demands of special-interest groups. The National Coalition on Health Care4 concluded that most Americans had little confidence in the health- care system. Its 1997 poll found that 8 out of 10 said that medical care quality was being compromised in the interest of profit. The Center for Health Economics Research5 concluded that the major source of public dissatisfaction was not quality but out-of-pocket costs, and that these costs decrease with better insurance cover- age. Other polls have found that the primary concern is with public access and that satisfaction with the system is far greater among those who are wealthy rather than poor, white rather than nonwhite, and healthy rather than disabled.6,7
Health care finance is the management of money (funds) intended to achieve health care delivery goals This chapter focuses on health-care costs, insurance coverage, insurance fraud, cost-control strategies, pro- posals for health care reform, and the Patient Protection and Affordable Care Act, which was signed into law in 2010.
HealtH-Care Costs
The annual cost of health care in the United States rose about 11% a year from 1960 through 1990, and about 7% a year since that time. In 2009 the cost totaled $2.49 trillion ($6797 per person).8 As shown in Table 24-1, $2.09 trillion of this was spent for personal health care, and the rest was spent for administration, research, con- struction, and public health activities. In 2011 actuaries
at the Centers for Medicare & Medicaid Services (CMS)9 estimated that the total would rise about 5.8% per year and would reach $4.6 trillion (19.8% of the gross do- mestic product [GDP]) by 2020. In 2009, 85.7% ($1.79 trillion) of personal health expenses were paid by third parties (private health in- surers and public agencies) and 14.3% ($299.3 billion) were paid by individuals. U.S. Department of Commerce data indicate that in 2009 personal-consumption expenditures for medical care totaled $1.97 trillion. (The Commerce Department’s medical-care total is less than that of the CMS because it does not include moneys from certain government programs.) This amount exceeded housing ($1.89 tril- lion), transportation ($882.7 billion), recreation ($879.4 billion), financial services and insurance ($747.8 billion), food ($746 billion), personal business ($578 billion), household operation ($403.1 billion), clothing and shoes ($334.8 billion), and education ($234.4 billion).10 Figure 24-1 summarizes how America’s health-care costs were financed and how the money was spent. The reasons for the rise have included (a) increasing use of costly high-tech equipment, (b) the high cost of treating such illnesses as AIDS and cancer, (c) aging of the population, (d) fraudulent practices by some provid- ers, (e) the large number and high cost of malpractice suits, (f) the administrative costs of complying with government regulations, (g) wasteful duplication of services, and (h) the practice of —testing that is medi- cally unnecessary but is ordered to protect the physician against the danger of a malpractice suit. Another factor is that greater insurance coverage (more people insured and greater coverage per person) has led consumers to demand more and better services and doctors to recom- mend more services. In 2008, the Commonwealth Fund compared the health systems of Australia, Canada, Denmark, France, Germany, Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States
• National expenditures for health care have risen at an alarming rate.
• An ideal health-care financing system would provide equity, access, efficiency, and high-quality care. Reform efforts have been stymied by competing interests and the inherent difficulty of the problems.
• Individuals can minimize some of their expenses through prudent consumer strategies.
Keep tHese points in Mind as You studY tHis CHapter
Key Concepts
Chapter Twenty-Four Health-Care Financing 489
and concluded that although per capita (per person) spending on health care in the United States is far greater than in the other countries, the U.S. system is not de- livering superior results. Its report stated that the major
reasons for high cost appear to be substantially higher prices (especially for drugs) and a “more fragmented care delivery that leads to duplication of resources and extensive use of poorly coordinated specialists.”11
sourCes oF Funds For HealtH-Care expenditures, 2009 (Billions oF dollars) Table 24-1
Expense Category Personal health care (84%) Hospital care Physician and clinical services Dental services Other professional services Home health care Prescription drugs Durable medical equipment Other medical nondurables Nursing home/CCRC care Other personal health care Total, personal health care
Other expenditures (16%) Program administration and
net cost of private insurance Govt. public health activities Research Structures and equipment
Total, all expenditures
Category Total
$ 759.1 (31%) 505.9 (22%) 102.2 (4%) 66.8 (3%) 68.3 (2%) 249.9 (11%) 34.9 (1%) 43.3 (2%) 137.0 (7%) 122.6 (3%) 2089.9 (86%)
163.0 (7%)
77.2 (3%) 45.3 (2%) 110.9 (1%)
2486.3 (100%)
Government Programs
$403.5 170.2
9.3 18.4 54.7 84.8 11.8 2.8
77.0 71.0
902.9
29.4
77.2 –
6.4
966.2
Out-of-Pocket Payments
$ 24.4 47.9 42.5 17.7 6.0 53.0 18.6
40.5 39.8
8.9 299.3
–
– – –
299.3
Private Insurance
$265.9 237.7
50.0 24.7 5.0
108.6 4.0 –
10.5 5.8
712.2
89.9
– – –
801.2
Other Third Party
$65.3 50.6 0.5 6.0 2.5
– – – 4.2 4.9
175.6
10.5
– – –
186.1
Source: Health Care Financing Administration.8 Some numbers do not add to totals because of rounding.
Where the Money Came From Where the Money Went
Other private source
Private health insurance
Hospital care
Medicaid
Medicare Other public programs
Out-of-pocket
Prescription drugs
Figure 24-1. How America’s health-care dollars were spent in 2009.8
31¢
6¢
20¢
27¢
13¢
22¢
36¢
4¢
7¢
8¢
17¢
10¢
Nursing home care
Program administration and net cost
Physician and clinical
services Other spending
Part Six Protection of the Consumer490
Personal health expenditures are very unevenly distributed. Consumers Union13 has concluded that (a) the sickest 10% of the population accounts for 68% of health-care expenditures; (b) for households with a head younger than 65, the percent of family income spent on premiums and out-of-pocket payments ranged from a high of 17% for families with income under $10,000 to 3% for families with income of $100,000 or more; (c) one in six households with a head younger than 65 spends 10% or more of its income on out-of-pocket costs plus directly paid premiums; and (d) half of the households headed by a person 65 or older pay more than 10% of their income on such costs, mainly because Medicare does not cover their prescription drugs. The Health Care Technology Institute12 has pointed out that Americans have mixed feelings about cost-con- trol (see the “Conflicting Attitudes” Personal Glimpse box).
Medical Fees Physicians generally base their fees on (a) the nature, extent, and complexity of the service; (b) the time in- volved; (c) the office overhead—rent, heat, lighting, equipment, supplies, and salaries of personnel; (d) the experience and expertise of the practitioner; (e) the area in which the physician practices; (f) the fees customarily charged by others in the community; and (g) in some circumstances, the economic status of the patient. Medi- cal fees are also influenced by the forces of supply and demand. Table 24-2 shows the median fees physicians charged in 2009 for outpatient visits. The FAIRHealth Educational Site (www.fairhealthconsumer.org) enables
consumers to estimate the local cost of common medical and dental procedures. Insurance plans pay practitioners in three ways. In the fee-for-service method, they are compensated for each service they render. Another arrangement is a salary from a hospital, group health insurance plan, or governmental or private organization or agency. Some members of group or managed-care plans may also re- ceive a share of the profits at the end of each year, based on the amount of service rendered. The third method is capitation, a fixed monthly amount paid for each patient (per capita) regardless of the extent of services used. Insurance companies generally base fee-for-service payments on what they consider usual, customary, and reasonable (UCR). “Usual” refers to a physician’s own charges during the previous year or years. “Customary” refers to the range of fees charged by all physicians in a given region. “Reasonable” refers to a fee within a given region or area that falls below the 90th percentile of the customary charges. Medicare uses the 75th percentile and pays 80% of this amount. Except for deductibles and co-insurance, physicians who accept assignment are not permitted to bill the patient for the difference between what they bill and what they collect from third-party payers. Federal regulations prohibit medical organiza- tions from establishing fee guidelines or fee schedules, which are considered anticompetitive. A few attempts have been made to influence medical costs by publishing physician directories that include fee information. These publications are not very useful because they quickly become outdated, many physi- cians refuse to provide the information, and fees do not reflect the quality of care, which is generally much more important.
Dental Fees Table 24-3 lists the average and 95th percentile fees charged for common procedures by general dentists and specialists in the United States in January 2009. This information may be helpful when preparing a budget for dental care or considering the purchase of dental insurance (see Chapter 23). Considerable evidence indicates that self-care and preventive dentistry can save consumers money. More important, however, are the benefits of freedom from pain and discomfort, retention of teeth, and less time spent obtaining dental care. The incidence of dental caries and periodontal disease can be substantially and cost-effectively reduced through the fluoridation of water supplies, topical application of fluorides, and plaque- control measures (see Chapter 7).
Conflicting Attitudes Since 1980, Americans often expressed, simultane- ously, two contradictory attitudes on medicine and its costs—they repeatedly wanted unrestricted access to the best medical care and related technology, and, at the same time, they wanted lower medical costs and cited expense as a major shortcoming of the U.S. health care system. During the same period, respondents who were asked to consider cost-stabilizing health insurance plans were unwilling to give up complete access to the latest—even if it was the costliest—medical technology. Respondents were willing to exclude only purely elec- tive care (i.e., cosmetic surgery) from national health care plans for cost control purposes. Health Care Technology Institute12
Personal Glimpse
Chapter Twenty-Four Health-Care Financing 491
pHYsiCian Fees For outpatient Visits, 2009 Table 24-2
CPT Code / Typical Time with Patient
New patients 99201 / 10 minutes 99202 / 20 minutes 99203 / 30 minutes 99204 / 45 minutes 99205 / 60 minutes Established patients 99211 / 5 minutes 99212 / 10 minutes 99213 / 15 minutes 99214 / 25 minutes 99215 / 40 minutes
Data source: Medical Fees in the United States.14
90th Percentile UCR ($)
101 146 209 293 371
54 86 117 177 260
Median UCR ($)
73 105 151 212 268
40 64 85 131 193
Typical Severity
Minimal Minor Low to moderate Moderate to high High Minimal Minor Low to moderate Moderate to high High
The fees to the right reflect usual, cus- tomary, and reasonable (UCR) fees as determined by insurance carriers in 2009. The applicable CPT code depends on the complexity of the evaluation and management involved. (Table 23-5 explains the coding system further.) The median UCR is the point at which half of the fees are at or below the amount listed and half are higher. Specialists tend to charge more than general practitioners, and fees also vary from one part of the U.S. to another. The fees paid by Medi- care were about 40% to 60% lower.
95th Percentile ($)
150 75
106 85 45 65
163 1000 1150
211 / 300
2420 / 2400
235 / 303
294 / 450 1180 / 1690
1960 / 4485
6000–7000
Services Diagnostic Complete intraoral x-ray series Bitewings, four films Preventive Prophylaxis (cleaning)—adult Prophylaxis (cleaning)—child Topical fluoride plus prophylaxis—child Sealant, per tooth Restorative Amalgam—one surface, permanent teeth Inlay, composite, one surface Crown, porcelain on nonprecious metal
Oral surgery Extraction, single tooth Implant placement Periodontics Scaling and root planing, per quadrant Endodontics Therapeutic pulpotomy (without final restoration) Root canal, molar Prosthodontics Complete denture, upper or lower Orthodontics Comprehensive treatment (cost depends on age)
Median Fees ($)*
108 43
75 55 30 44
105 688 850
156 / 250 1714 / 1900
135 / 150
150 / 250 850 / 1050
1300 / 2200
4870–5600
Fees For CoMMon dental serViCes, 2009 Table 24–3
*The fees listed above the dividing line are for general dentists. Specialists who do the same services tend to charge more for them. In the listings below the line, except for orthodontic fees, the first number is the median fee for general dentists and the second number the median for specialists. Fees for general dentists and orthodontists are similar. Fees tend to be higher in highly populated areas. Source: American Dental Association, 2009 Survey of Dental Fees.15
Part Six Protection of the Consumer492
Hospital and Long-Term–Care Charges In 2009, the estimated average hospital cost per inpatient day was $185316 and the average length of stay was about 5 days. This is what it cost the hospitals to deliver their services, not what patients or insurance companies paid, which was more. These figures do not include medical and surgical fees. Consumers may be able to reduce hospital and sur- gery costs by (a) getting a second opinion when elective surgery is advised; (b) not extending hospital stays for the sake of convenience; (c) comparing prices when hospitalization is needed (some areas have developed consumer guides that provide information about charges, services, and other matters); (d) choosing providers who have contracts with one’s insurer; and (e) monitoring hospital bills carefully to be certain all charges are valid. Billing errors, which are common, can include charges for unreceived services, as well as overcharges. The cost per day at a nursing home depends on the nature of the care rendered, the type of facility, the region of the United States, and several other factors. In 2009, the average yearly cost for a semiprivate room in a nursing home was $72,270 ($198/day).17 For many people, nursing home expenses are by far the largest health-related out-of-pocket expense. Reducing nursing home expenses may be difficult, but it may help to investigate Medicare and Medicaid coverage, purchase long-term insurance (see Chapter 23), or explore less-expensive alternatives to nursing home care (see Chapter 22). Some people qualify for Medicaid by incurring medical expenses until their net income after medical expenses is low enough to qualify. This method is called “spending down.” Some people
transfer assets to someone other than their spouse so these assets will not have to be spent to establish Med- icaid eligibility. Since recently transferred assets are considered part of the applicant’s net worth, the transfer must take place several years before applying.18 This method is controversial but legal.
Budgeting Considerations When budgeting for health care, consumers should con- sider that (a) out-of-pocket expenses are likely to occur each year; (b) the 2009 average was $974 per person; (c) health-care costs tend to increase as people grow older; and (d) the appropriate amount to allocate should depend on the number of people in the family unit, how old they are, and the extent of insurance coverage. Table 24-4 provides further details about per capita out-of-pocket personal health-care expenses for 2009.
Cost-Control MetHods
Most health care provided by practitioners in the United States is paid for on a fee-for-service basis. Health plans generally pay hospitals fixed amounts, either per admis- sion or per day.19 Various strategies are being used to try to control escalating medical and hospital costs. Traditional in- surance companies can use several measures. They can raise deductibles and co-payment amounts, limit what they pay for each service, limit or exclude certain ser- vices, limit maximum total benefits, and exclude people with pre-existing illness. They also can use utilization management to limit payment to medically necessary services. For example, they can require a confirmatory second opinion before authorizing certain types of elec- tive surgery. Managed-care plans can limit their sub- scribers’ choice of providers to those who have agreed to accept lower fees (or capitation) or have exhibited a pattern of providing lower-cost care. These plans also deny coverage of diagnostic tests and the services of specialists unless the primary physician authorizes them. All third-party payers can insist that various diagnostic tests and surgical procedures be done on an outpatient rather than an inpatient basis. Managed-care plans can use additional measures that influence physician behavior. They may require preauthorization from the plan before hospitalizing a patient or ordering certain expensive tests. They may exclude certain drugs from coverage and require that generic drugs be prescribed when available. They use aggressive utilization review programs to detect what they consider medically unnecessary or inappropriate care. They can also reduce costs by creating econo-
per Capita out-oF-poCKet personal HealtH-Care expenditures, 2009
Table 24–4
Category Amount
Hospital care $ 79 Physician and clinical services 156 Dental services 138 Other professional services 58 Home health care 20 Other health/residential/personal care 29 Prescription drugs 172 Durable medical equipment 60 Other medical nondurables 132 Nursing home and CCRC facilities 130 Total 974
Source: Centers for Medicare & Medicaid Services.8
Chapter Twenty-Four Health-Care Financing 493
mies of scale, reducing duplication of services, issuing treatment guidelines, and using financial incentives to encourage cost-conscious decisions. Managed-care plans usually compensate physicians with capitation fees or a salary. In addition, they typically use incentives to limit use of diagnostic tests, referrals to other physicians, hospital care, or other ancillary services. Many plans pay bonuses that depend on how little the plan has to spend for these services. Some plans withhold a percentage of the physician’s compensation until the end of the year to cover any shortfalls in the amounts budgeted for patient-care expenditures. If there is no shortfall, or if the shortfall can be covered by part of the withheld fees, the remainder of the withheld amount is distributed to the physicians. Since 1983 Medicare has paid for hospital services according to a predetermined schedule for about 500 diagnosis-related groups (DRGs). This system provides an incentive to shorten hospital stays and minimize the cost of providing their services. Hospitals able to provide services for less than the government rate can retain the difference. Thus a hospital that keeps a patient for 2 days receives as much as one that keeps a similar patient for 6 days. To ensure that the quality of care is not affected, hospitals treating Medicare patients must conduct strict peer review. Concerns have been raised that some hospi- tals discharge patients who still need treatment. Patients who believe they are being prematurely discharged can: (a) ask for a written notice, which will be needed for appeal, (b) seek help from their doctor, and (c) appeal to the hospital peer review organization. Many authorities have expressed concern that finan- cial considerations may undermine patient care. Wenger and Shapiro,20 for example, suggested that utilization review programs explore possible underuse of care in addition to overuse. The American Medical Association (AMA) Council on Ethical and Judicial Affairs21 has stated:
While efforts to contain costs are critical and while many of the approaches of managed care have an impact, managed care can compromise the quality and integrity of the physician- patient relationship and reduce the quality of care received by patients. In particular, by creating conflicting loyalties for the physician, some of the techniques of managed care can undermine the physician’s fundamental obligation to serve as patient advocate. Moreover, in their zeal to control utilization, managed care plans may withhold appropriate diagnostic procedures or treatment. . . . Efforts to contain health care costs should not place patient welfare at risk. Thus, financial incentives are permissible only if they promote the cost-effective delivery of health care and not the withholding of medically necessary care.
Many state legislators have expressed concerns that HMO cost-cutting measures have been too stringent.22
Many states have passed laws requiring HMOs to permit women to remain in the hospital at least 48 hours (or a time recommended by the American College of Ob- stetricians and Gynecologists) after giving birth. Some states have made it harder for HMOs to deny payments for emergency-department visits that turn out not to be emergencies. A few states have enacted laws that require prospective enrollees to be told how HMO physicians are compensated. Many states have banned “gag clauses” (HMO rules that prevent doctors from telling patients about treatment options that the HMO does not cover).24
Provider Strategies Escalating costs and the prospect of greater government intervention have stimulated rapid and sweeping changes in the way in which the health marketplace is organized. Hospitals have merged with other hospitals, forming purchasing alliances, hiring large numbers of physicians, and developing integrated managed-care systems that include the full gamut of medical services. Profit-making organizations have been buying hospitals and physician practices. Physicians have formed independent practice associations and other networks so that they can bargain more effectively with managed-care organizations. Group practices are becoming larger. Some Blue Cross/ Blue Shield organizations have converted from nonprofit to commercial status. Many facilities now use physician assistants and/or nurse practitioners who deliver services less expensively
Consumer Health Insight
Health Priorities The U.S. spends billions on healthcare services of questionable value while basic, evidence-based pre- ventive services are not getting done as often as they should. Yet the time available to deliver healthcare services is limited. Brief clinician office visits must ad- dress chronic conditions, acute illness, and preventive care. In this environment, prioritization of healthcare services is occurring, but it is rarely systematic or rational. And the consequences of misplaced priorities are high: people die and illnesses worsen because the most important preventive services do not get done. Health outcomes in the U.S. could be improved at less expense if the health care system, clinicians, and patients gave priority to services that were most beneficial and offered the greatest value. — Partnership for Prevention23
Part Six Protection of the Consumer494
Rights and Responsibilities” box and the Consumer Tip box on pages 495 and 496 suggest how to protect your health and avoid unnecessary expense. Some of the suggestions are simple to carry out, whereas others require diligent effort.
insuranCe Fraud and aBuse
Federal officials and insurance company executives believe that insurance fraud and abuse are widespread and very costly to America’s health-care system. Fraud involves billing for services that are not rendered. Abuse involves multiple services that are not medically necessary, such as a laboratory test performed on large numbers of patients when only a few should have it. Consumers can detect certain frauds by examining in- surance payment reports to see whether they accurately reflect the services rendered. The Consumer Tip Box tells how to spot a criminal scheme known as a “personal injury mill.”
Financial Abuse Many insurance companies base their coverage on the physician’s “usual and customary fee.” Some physicians charge insured patients more than uninsured ones but represent to the insurance companies that the higher fee is the usual one, when in fact it is not.
than physicians. Electronic medical record systems have the potential to make the delivery of health care safer, more effective, and more efficient.25
There is widespread concern that small organiza- tions will be unable to compete effectively with large ones because large ones can achieve economies of scale. It is also possible that mergers will reduce competition enough to ultimately raise prices.26
Employer Strategies Most health insurance is obtained through employers. As health-care costs have escalated, it has become in- creasingly difficult for businesses to absorb the expense while still remaining profitable. As a result, many have reduced health-care benefits, switched to managed-care plans, cut retiree benefits, or are requiring employees and retirees to pay part of the premium costs. About half of employers now self-insure (assuming the financial risk) but hire an insurance company or other third party to administer their program.27 Today the vast majority of those who obtain health services through an employer are in some form of managed care.
Consumer Strategies Health-care costs and benefits can be defined both in terms of dollars and the presence or absence of disease. The National Health Council’s “Principles of Patients’
• Participants in minor accidents are advised that they may have been injured more seriously than they think.
• Participants are advised that their care won’t cost any- thing because insurance will pay for it.
• The diagnostic evaluation process is set up by a lawyer who refers to multiple practitioners.
• Multiple professional appointments take place at the same facility or on the same day. There is no real consultation in which one doctor advises another. The original physician is never seen again, and subsequent physical examinations are cursory.
√ Consumer Tip
How to Spot a Personal Injury Mill28
Personal injury mills are conspiracies to provide unnecessary services in order to create large insurance claims. This en- ables providers to profit and attorneys who represent injured clients to get higher settlements (and therefore higher fees for cases taken on a contingency basis). Large mills can involve hundreds of participants and steal many millions of dollars, causing higher insurance premiums and higher taxes. In many cases, insurance claimants are advised that they can make money by doing what is recommended and that failure to participate could adversely affect their legal case. However, false reports of medical diagnoses or loss of functionality can cause trouble for patients who later seek employment, apply for insurance, or actually become disabled and apply for disability. Knowledgeable participants can be prosecuted for fraud. The scenarios that should arouse suspicion include:
• Many patients get the same treatment on a similar schedule.
• Multiple diagnostic tests are recommended with little or no explanation of the results.
• Patients are said to have suffered significant injury even though they have few or no symptoms.
• The treatment remains the same—with multiple modali- ties—whether or not the patient is feeling better.
• Practitioners are willing to forego the deductible or co- payment, and payment reports are coded and go to the attorney rather than the patient.
Chapter Twenty-Four Health-Care Financing 495
national HealtH council’s PrinciPles of Patients’ rigHts and resPonsibilities
• All patients have the right to know what provider incen- tives or restrictions might influence practice patterns. Patients also have the right to know the basis for pro- vider payments, any potential conflicts of interest that may exist, and any financial incentives and clinical rules (e.g., quality assurance procedures, treatment protocols or practice guidelines, and utilization review require- ments) which could affect provider practice patterns.
• All patients, to the extent capable, have the responsibil- ity to pursue a healthy lifestyle. Patients should pursue lifestyle factors known to promote positive health re- sults, such as proper diet and nutrition, adequate rest, and regular exercise. Simultaneously, they should avoid behaviors known to be detrimental to one’s health, such as smoking, excessive alcohol consumption, and drug abuse.
• All patients, to the extent capable, have the responsibil- ity to become knowledgeable about their health plans. Patients should read and become familiar with the terms, coverage provisions, rules, and restrictions of their health plans. They should not be hesitant to inquire with appropriate sources when additional information or clarification is needed about these matters.
• All patients, to the extent capable, have the responsi- bility to actively participate in decisions about their health care. Patients should seek, when recommended for their age group, an annual medical examination and be present at all other scheduled health-care appoint- ments. They should provide accurate information to caregivers regarding their medical and personal histories and current symptoms and conditions. They should ask questions of providers to determine the potential risks, benefits, and costs of treatment alternatives. Where appropriate, this should include information about the availability and accessibility of experimental treatments and clinical trials. Additionally, patients should also seek and read literature about their conditions and weigh all pertinent factors in making informed decisions about their care.
• All patients, to the extent capable, have the responsi- bility to cooperate fully on mutually accepted courses of treatment. Patients should cooperate fully with pro- viders in complying with mutually accepted treatment regimens and regularly reporting on treatment progress. If serious side effects, complications, or worsening of the condition occur, they should notify their provid- ers promptly. They should also inform providers of other medications and treatments they are pursuing simultaneously.
Endorsed by the National Health Council, March 22, 1995.
• All patients have the right to informed consent in treat- ment decisions, timely access to specialty care, and confidentiality protections. Patients should be treated courteously with dignity and respect. Before consenting to specific care choices, they should receive complete and easily understood information about their condition and treatment options. Patients should be entitled to: coverage for qualified second opinions; timely referral and access to needed specialty care and other services; confidentiality of their medical records and communica- tions with providers; and respect for their legal advanced directives or living wills.
• All patients have the right to concise and easily un- derstood information about their coverage. This infor- mation should include the range of covered benefits, required authorizations, and service restrictions or limi- tations (such as on the use of certain health care provid- ers, prescription drugs, and “experimental” treatments). Plans should also be encouraged to provide information assistance through patient ombudsmen knowledgeable about coverage provisions and processes.
• All patients have the right to know how coverage pay- ment decisions are made and how they can be fairly and openly appealed. Patients are entitled to informa- tion about how coverage decisions are made (how “medically necessary” treatment is determined) and how quality assurance is conducted. Patients and their caregivers should have access to an open, simple, and timely process to appeal negative coverage decisions on tests and treatments they believe are necessary.
• All patients have the right to complete and easily un- derstood information about the costs of their coverage and care. This information should include the premium costs for their benefits package, the amount of any pa- tient out-of-pocket cost obligations (e.g., deductibles, co-payments, and additional premiums), and any cata- strophic cost limits. Upon request, patients should be informed of the costs of services they’ve been rendered and treatment options proposed.
• All patients have the right to a reasonable choice of pro- viders and useful information about provider options. Patients are entitled to a reasonable choice of health-care providers and the ability to change providers if dissatis- fied with their care. Information should be available on provider credentials and facility accreditation reports, provider expertise relative to specific diseases and dis- orders, and the criteria used by provider networks to select and retain caregivers. The latter should include information about whether and how a patient can remain with a caregiver who leaves or is not part of a plan network.
Part Six Protection of the Consumer496
• Acquire a primary physician, preferably before you are ill. Chapter 5 will help you find one and to communicate efficiently. Don’t attempt to seek care from one specialist after another without a primary physician as a coordinator.
• Use the preventive measures described in Chapter 14. Do not smoke, eat sensibly, maintain optimum weight, exercise sufficiently, avoid excessive intake of alcohol, keep immunizations up-to-date, wear a safety belt in automobiles, and have a smoke detector and possibly a carbon monoxide detector in your home.
• Have periodic health examinations as recommended in Chapter 5.
• Find out in advance about fees and payment policies. If you have insurance, ask whether the doctor will accept assignment. If paying for particular services may be a problem, discuss it with your doctor or the doctor’s of- fice staff. Some fees are negotiable, and most doctors will permit payment in installments. If you expect costs to be a problem, indicating this may also encourage the doctor to increase consideration of costs when ordering services or prescribing medication. The Healthcare Blue Book (www.healthcarebluebook.com) can help you estimate out-of-pocket expenses.
• Use the telephone discriminately to obtain needed infor- mation about your concerns. However, do not expect this procedure always to be a substitute for an office visit. Re- member that provider time is valuable; have your thoughts well organized before telephoning.
• A local health department clinic may provide certain tests without cost and will inform your physician of the results. Keep in mind, however, that isolated tests are not a substitute for an overall diagnostic evaluation. The local health department may also provide immunizations and other health services without charge.
• Take advantage of outpatient services, including surgery, whenever possible, since these are much less costly than inpatient services.
• Visit your doctor during regular office hours except in emergencies. Avoid unnecessary use of hospital emer- gency rooms, which are far more costly than physicians’ offices or ambulatory care centers.
• Do not press to remain in a hospital longer than neces- sary. Avoid entering the hospital on a weekend if tests or procedures you need will not begin until Monday.
• Check your hospital bill carefully and dispute errors. If faced with a large bill that is not covered by insurance, it may be possible to negotiate a lower cost.29
• Become familiar with local health facilities and organiza- tions. (For example, the American Cancer Society and the American Lung Association have brochures and programs for people who want to stop smoking.) Know ahead of time what to do and whom to call in case of emergency.
• A dental school clinic may be able to provide dental ser- vices at lower cost.
• Mental health care may be less expensive through group therapy, self-help groups, or clinics.
• When elective surgery is recommended, seek a reasonable explanation of what it entails, why it is recommended, and what the risks are. Ask if a medical alternative is available and consider getting a second opinion (see Chapter 5). Your primary physician’s opinion may be as valuable as that of a second surgeon, or even more valuable.
• Appropriate home-care services, where available, are generally less expensive than hospital and nursing home care. Medicare, Medicaid, and insurance companies are often willing to pay for these services.
• Attempt to purchase prescription drugs by generic name rather than brand name. Compare prices in several phar- macies and follow the other suggestions presented in Chapter 17.
• Do not waste money on dietary supplements. Unless you have a specific concern that makes supplementation advisable, sensible eating can provide the nutrients you need (see Chapter 11). If you wish to take a multivitamin, tablets are available for 5¢ a day or less. Never ingest doses exceeding 100% of the Recommended Dietary Allow- ances (RDAs) or Daily Values (DVs) without competent medical advice.
• Read product labels and adhere to any instructions or warnings.
• Learn the names of all medications you use; take them as prescribed.
• Brush and floss your teeth at least once a day. Invest in periodic dental checkups at intervals recommended by your dentist. Support fluoridation of local drinking water, and use other types of fluoride supplementation if recom- mended by your dentist.
• Make sure you understand how to determine whether to self-treat and when to contact a physician if a health problem arises (see Chapter 14).
• Be cautious about health information unless you are sure that its source is trustworthy. Chapter 2 and the Appendix identify many useful sources.
• Purchase health insurance and make sure that its cover- age is adequate to prevent financial catastrophe in case of serious or prolonged illness. An HMO or other managed- care plan may be less expensive and provide appropriate medical services. Also consider using a consumer-directed expense account. Chapter 23 covers these topics.
• If you belong to a health plan, be sure to follow its rules regarding preauthorization and the use of participating providers. Do not use out-of-network (nonparticipating) providers without knowing what extra costs—especially hospital costs— may be involved.
• Know the signs of quackery so you can avoid wasting money on senseless products or services. Be wary of practitioners who describe themselves as practicing complementary, alternative, or integrative medicine.
Guidelines for Reducing Personal Health-Care Costs
√ Consumer Tip
Chapter Twenty-Four Health-Care Financing 497
Another illegal procedure is “unbundling,” which involves billing separately for procedures that normally are covered by a single fee. An example would be a po- diatrist who operates on three toes and submits claims for three separate operations. Other forms of fraud include upcoding (charging for a more complex service than was performed), miscoding (using a code number that does not apply to the procedure), charging for a service that was not performed, deliberately ordering unnecessary tests for the purpose of financial gain, and compensation (kickback) for making a referral. Although no precise dollar amount can be de- termined, the cost of insurance fraud and abuse is enormous. In fiscal year 2009, for example, the CMS estimated that $24.1 billion (7.8%) of the Medicare fee- for-service claims it paid did not meet program require- ments. Although not all involved fraud, they should not have been paid.30 The Department of Justice31 reported that in fiscal year 2010 it had opened 1116 new criminal health-care– fraud investigations involving 2095 potential defendants. Federal prosecutors had 1787 health-care–fraud criminal investigations pending, involving 2977 potential defen- dants, and filed criminal charges in 488 cases involving 931 defendants. During that year 726 defendants were convicted of crimes related to health-care fraud. There also were 942 new civil health-care–fraud investigations opened and 1290 civil health-care–fraud matters that were pending at the end of the fiscal year. The Federal Bureau of Investigation and the Office of the Inspector General (OIG) have assigned hundreds of special agents to insurance-fraud projects. These agencies have jurisdiction over private plans as well as public ones. The following cases illustrate the variety of problems that have been uncovered. During the late 1990s, an FBI investigation con- cluded that a chain of hospitals doing business as Columbia/HCA had been overbilling Medicare and giving kickbacks to doctors who steered patients to its hospitals. The overbilling included upcoding lesser procedures to get higher reimbursements and billing for lab tests that were not medically necessary and were not ordered by physicians. The situation was settled in 2003 with a set of guilty pleas and criminal and civil fines totaling $1.7 billion. The U.S. Department of Justice referred to the matter as the “largest health care fraud case in U.S. history.”32
In another major case, two California men received lengthy prison sentences after pleading guilty to multiple felony charges related to a bogus medical testing scheme.
After establishing mobile testing laboratories, the men advertised free preventive physical examinations and testing. They and a network of physicians (some unli- censed) then billed insurance companies for a battery of expensive tests. Over a 10-year period the scheme generated more than $1 billion in fraudulent billings that resulted in payment of more than $50 million.34
An Illinois physician was sentenced to 25 months in prison and ordered to pay a $25,000 fine and $41,460 in restitution for defrauding Medicare and private insurers. Unable to recruit physicians and sufficient referrals for a multimillion-dollar diagnostic clinic he had built, the physician had billed $4000 to $6000 for unnecessary tests on every patient who entered the clinic. He also attempted to substantiate the need for testing by entering nonexistent symptoms in patient records.35
A Pennsylvania pharmacist was sentenced to 18 months in prison and ordered to pay $576,000 in restitu- tion after pleading guilty to charges of drug adulteration, health-care fraud, and mail fraud. The pharmacist, who owned and operated a compounding pharmacy, replaced proprietary drugs with compounded versions but billed insurers as if the proprietary drugs were dispensed. The investigation also revealed that he manufactured the drugs under unsanitary conditions and that some were contaminated with bacteria.31
Huge “Rent-a-Patient Scheme” Unravels
Since 2004, three doctors and sixteen other people have been charged with conspiracy, grand theft, insurance fraud and/or tax evasion in connection with a scheme that resulted in more than 2800 healthy people un- dergoing unnecessary surgery at the Unity Outpatient Surgery Center in California. The ringleaders paid recruiters (“cappers”) to recruit “patients” from all over the United States, arrange transportation, schedule procedures, and instruct them on what to say. In return for their participation, the “patients” received from $300 to $1000 or were given credit toward inexpensive cosmetic surgery. The most common procedures were colonoscopies, an upper gastrointestinal procedure, sweaty palms surgery, hemorrhoid surgery, and pain- management procedures. The perpetrators billed insur- ance companies more than $150 million and collected more than $20 million in fees during a 9-month period. By August 2011, nine participants had pleaded guilty and the rest were awaiting trial.33
Personal Glimpse
Part Six Protection of the Consumer498
The former chief financial officer of a California hospital pleaded guilty to paying illegal kickbacks. Under the scheme, “marketers” were paid to recruit homeless persons from Los Angeles’ Skid Row and have them transported to the hospital, where many received inpatient services that were not medically necessary.31
The manager and a delivery employee of a medi- cal supply store were sentenced to 120 months and 41 months of incarceration, respectively, and ordered to pay $453,112 and $80,000 in restitution, jointly and sever- ally, for their roles in a durable medical equipment fraud scheme related to power wheelchairs and other items that were medically unnecessary and improperly billed to Medicare as catastrophe-related in connection with four Gulf Coast hurricanes. Some wheelchairs were billed for people who didn’t need them and others were billed as replacements even though the original equipment was not damaged.36
A New York podiatrist was sentenced to 3 years in prison and ordered to pay $5.4 million in restitution for health-care fraud and making false statements. The podi- atrist systematically billed Medicare for routine foot care not covered by Medicare and for services not rendered, including abscess drainages and costly tests.31 Some abusive operations involve for-profit corpora- tions that hire practitioners to work in clinics that strive to maximize profits by providing unnecessary services. Most states ban the “corporate practice of medicine” by requiring that for-profit clinics be practitioner-owned and directed. However, some private equity firms have set up sham “owners” who, for a modest monthly stipend, will falsely certify to the states that they own and control the corporation. Moriarty and Quintana state that regula- tory agencies could easily expose sham ownerships by forcing registrants to disclose who actually owns and controls these clinics. However, few such operators have been actively pursued.37
Consumers who encounter suspicious practices in- volving Medicare, Medicaid, or other federal programs should report them to the OIG hotline (800-368-5779). One practice that is easily detectable is the routine waiver of Part B co-payments and deductibles. It is legal for providers not to charge Medicare recipients who have a genuine financial hardship, but it is not legal to provide “completely free” care or “discounts” to all patients or to collect only from those who have Medigap insurance. Studies have shown that if patients are required to pay for even a small portion of their care, they will select items or services because they are medically needed rather than because they are free—thus lowering the overall cost of the Medicare program.38
national HealtH insuranCe (nHi) The United States spends more money and a larger share of its resources for health care than any other country in the world. Yet the 2010 National Health Interview Survey found that 48.6 million persons (16%) of all ages were uninsured at the time of interview, 60.3 million (19.8%) had been uninsured for at least part of the year prior to interview, and 35.7 million (11.7%) had been un- insured for more than a year at the time of interview.39 Many others were underinsured.40 “Underinsured” means having insurance coverage all year but inadequate financial protection because: (a) annual out-of-pocket medical expenses amount to 10% or more of income; (b) health plan deductibles equal or exceed 5% of income; or (c) among adults with incomes under 200% of the federal poverty level, out-of-pocket medical expenses amount to 5% or more of income. Angell3 has noted:
[The U.S.] is the only industrialized country that treats health care like a market commodity instead of a social service. Thus, health care is distributed not according to medical need but, rather, according to the ability to pay. There is a great mis- match, however, between medical need and the ability to pay. In fact, those with the greatest need are those least able to pay.
Table 24–5
top HealtH-related loBBYists, 2008-10*
Pharmaceutical Research & Mfrs. of America $68,110,520 American Medical Association 63,830,000 Blue Cross/Blue Shield 60,531,745 American Hospital Association 56,738,218 Pfizer Inc. (drug company) 51,329,268 Altria Group (mainly tobacco) 36,970,000 Amgen Inc (biotechnology) 32,850,000 Eli Lilly and Company (drug company) 31,240,000 America’s Health Insurance Plans 25,690,000 Biotechnology Industry Organization 23,480,000 Sanofi-Aventis (drug company) 23,084.000 GlaxoSmithKline (drug company) 21,820,000 Bayer AG (drug company) 20,074,582 Johnson & Johnson (health-care products) 19,975,000 Merck & Co. (drug company) 18,662,510 Novartis AG (drug company) 17,368,090 AstraZenica PLC (drug company) 16,918,000 Abbott Laboratories (drug company) 14,860,000 Roche Holdings (drug company) 14,158,524 Medtronic Inc. (medical devices) 13,139,018 United Health Group (health services/HMO) 12,080,000
*Total 2008-10 payments to lobbying firms plus in-house expenses for lobbying activities. Does not include campaign contributions. Data source: Center for Responsive Politics (www.opensecrets.org).
Chapter Twenty-Four Health-Care Financing 499
In the first half of the 20th century, most health insurance was provided to those who could afford it by state-based, non-profit Blue Cross / Blue Shield plans (BCBS), which based their premiums on a community rating system; to calculate their premiums, they took the costs of their enrollees, added a reasonable overhead contribution, and divided that by the number of enrollees. Under this system, the young healthy enrollees paid more to subsidize the in- surance cost of the older, more chronically ill ones. Some libertarians would consider this unfair, but if the young lived long enough they would become old. Such an arrange- ment is fundamental to the definition of health insurance. At first, the for-profit insurance companies considered health insurance too risky because of uncontrolled costs or adverse risk that health insurance caries. But by 1955, these companies figured out how to manage the risks and entered the health insurance market. To deal with adverse risk, they developed the concept of pre-existing conditions to exclude the sick from insurance coverage and applied liability-style risk rating to health insurance premiums which reduced the premiums for the young while mak- ing insurance unaffordable for the older population and thus removing the associated risk of the older popula- tion. Thus, risk rating of premiums effectively ended the subsidy of young for the cost of the care of the older. The risk-based premium approach is appropriate for the auto liability insurance, where people are responsible for their driving record. But risk rating is totally inap- propriate for human beings who cannot control their ge- netic inheritance, which plays a large role in their overall health. However, risk rating and pre-existing condition exclusions did protect the for-profit health insurance companies from the adverse risk of health insurance by denying access to insurance to those who need it most. The introduction of risk-based premiums immediately caused major problems for the non-profit BCBS plans be- cause, if they continued the community rating system, they would end up with all the sick (adverse selected popula- tion) and all the young healthy enrollees would flock to the cheaper rates of the for-profit risk-based premium system. This forced the non-profit BCBS’s to go to risk-based premiums and act like the for-profits. Today, for example, there is little difference between BCBS of NC and CIGNA. How for-profit health insurance corporations work is lucidly explained in the recent testimony of former insur- ance company executive Wendell Potter before the U.S. Senate Committee on Commerce, Science and Transporta- tion. In a blistering attack reminiscent of the attack that laid bare tobacco company deception, Potter41 described how for-profit companies work to maximize their income. Another major problem is the total number of health in- surance plans that are offered by the health insurance indus- try and the lack of any real regulation that would ensure that
Personal Glimpse
they are adequate to cover the needs of the enrollees. The huge numbers of plans challenge doctors and hospitals to fig- ure out what services are covered by what plans. Such choice drives the administrative costs for both the insurers and the providers higher than any other health insurance system in the world. However, it is profitable for the manufacturers of large mainframe computers and billing software vendors, but adds billions to the administrative cost of the health- care system, and still hospitals cannot get our bills straight. Further, the U.S. health-care system has the greatest number of administrative personnel of any country in the world. It is no wonder that our per-capita costs are 1.6 times those of other countries, even though millions have no health insurance. If these administrative costs could be reduced to the European or Canadian level, substantial funds would become available to cover a part of the insur- ance cost of the 52 to 55 million uninsured Americans for whom health care is difficult or impossible to get. Although the insurance industry is trying to portray itself as interested in health care reform, it really is not. In an interview with Bill Moyers, Potter described how the companies plan to sabotage health-care reform and use the political system to protect their interests. If you really want to understand the role of health insurance companies in our society, invest the 30 minutes needed to watch this broadcast (www.pbs.org/moyers/journal/07312009/watch.html). It is time to face the fact that there are absolutely no market solutions for the chronically and mentally ill in a for-profit health insurance system. The fiduciary respon- sibility of boards of directors and executives of for-profit health insurance corporations is to maximize the income of the corporations for investors. Any approach that keeps present for-profit and not-for-profit insurance companies with their plethora of insurance plans alive makes it im- possible to control costs and free the billions of dollars that today go to administrative costs and make these funds available for patient care. All the existing health insurance companies must be eliminated. We need a single-payer insurance system that covers every person in the country for medical, mental and dental health care. The cost of the system should be funded by income taxes paid by each adult/family in the country. It should provide universal access to care no matter where you are in the country, with equal quality and quantity and without regard to your wealth. It is time to face the reality that affordability and cost control are only possible with a single-payer system. The present insurance system is both morally and financially bankrupt and cannot be sustained. It is time to face reality and move in an orderly fashion to a single-payer health insurance system and join the civilized world. It may not be possible to achieve all of the necessary reforms quickly, but the direction we need to take is clear. — John Hammond, PhD.42
Why Insurance Reform Is Desperately Needed
Part Six Protection of the Consumer500
Reform Principles and Proposals Many years ago, Harvard economist Rashi Fein, Ph.D.,43 pointed out that Americans want assurance that they will have access, employers want relief from increasing costs, the federal government wants to reduce its growing deficit, and doctors and hospitals want to replace intru- sions into their clinical decisions with more effective ways to control costs. Consumers Union believes the key issues are univer- sal coverage; fair allocation of costs among government, employers, and consumers; improved safety; basing care on science rather than financial incentives; and greater attention to prevention.44 The National Coalition on Health Care,45 a broad-based bipartisan organization, has called for reform based on five principles: universal coverage, cost management, improved quality and safety, equitable financing, and simplified administration. Since 2003, the Physicians’ Working Group for Single-Payer National Health Insurance46 has been ad- vocating a detailed proposal that is summarized below. The group estimated that its plan would save at least
$200 billion annually (more than enough to cover the uninsured) by eliminating the high overhead and profits of the private investor-owned insurance industry, re- ducing marketing expenses, and reducing the expenses associated with processing burdensome paperwork. The Personal Glimpse Box on page 499 asserts that a single-payer plan is the only way to achieve an equitable national health system. The American Medical Association supports giv- ing more people access to health care, but it opposes any provisions that would limit fee-for-service, set fee schedules, establish a single-payer system, set spending caps, or establish residency training quotas. The AMA also wants substantial malpractice reform. Drug compa- nies are opposed to any plan that would jeopardize their (excessive) profits. Proposals based on expansion of consumer-driven health plans (see Chapter 23) were also advocated, but these received little legislative attention. In addition to making public comments, many orga- nizations promote their views through lobbying activities
ProPosal of tHe PHYsicians’ WorKing grouP for single-PaYer national HealtH insurance46
be appropriated separately based on community needs. Investor-owned hospitals would be converted to nonprofit status and their owners compensated for past investment.
• Payment for physicians and outpatient care: Practitioners could choose from three payment options: (1) fee-for- service, (2) salaried practice in institutions receiving global budgets, or (3) salaried practice in group practices or HMOs receiving capitation payments. Investor-owned HMOs and group practices would be converted to nonprofit status.
• Long-term care: Americans of all ages would be covered for all necessary home and nursing home care. Persons un- able to perform activities of daily living would be eligible for services. A local public agency in each community would determine eligibility, coordinate care, and contract with providers. For-profit nursing homes and home-care agencies would be converted to not-for-profit status. In- dividual long-term care providers would be paid on either a fee-for-service or salaried basis.
• Medications and supplies: The program would pay for all medically necessary prescription drugs and medical sup- plies, based on a national formulary established by experts. The program would negotiate drug and equipment prices with manufacturers.
• Capital spending: The NHI budget would fund the con- struction of health facilities and the purchase of expensive equipment. Regional health planning boards would allocate these funds. These boards would also oversee privately funded projects that might increase future publicly sup- ported operating costs.
Basic Principles • Access to comprehensive health care is a human right. It
is the responsibility of society, through its government, to ensure this right. Coverage should not be tied to employ- ment.
• The right to choose and change one’s physician is funda- mental to patient autonomy.
• Pursuit of corporate profit and personal fortune have no place in caregiving. They create enormous waste and too often warp clinical decision-making.
• The public should set health policies and budgets. Personal medical decisions must be made by patients with their caregivers, not by corporate or government bureaucrats.
Key Features • Eligibility and coverage: A single public plan would
cover every American for all medically necessary ser- vices, including long-term care, mental health and dental services, and prescription drugs and supplies. Unnecessary or ineffective services would be excluded from coverage. Private insurance duplicating the public coverage would be proscribed. Patient co-payments and deductibles would also be eliminated.
• Hospital payment: Each hospital would receive a monthly payment to cover operating expenses. The amount would be negotiated annually. Hospitals would not bill for non- covered services and could not use their operating budgets for expansion, profit, excessive executives’ incomes, mar- keting, or major capital purchases or leases. Major capital expenditures would come from the NHI fund and would
Chapter Twenty-Four Health-Care Financing 501
and campaign contributions. Table 24-5 on page 498 lists what the 21 largest health-related spenders spent on lobbying activities from 2008 through 2010.
The Patient Protection and Affordable Care Act On March 23, 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act PPACA), which was hoped to control health-care costs; provide access to quality, affordable health care for Americans; and reduce the deficit. The main provisions are summarized in Table 23-2 on pages 472 and 473. Shortly after the bill was signed, the attorneys general of many states filed suit to challenge the right of the federal government to mandate that Americans purchase insurance. Since lower court decisions have been conflicting, the issue will ultimately be decided by the U.S. Supreme Court. If PPACA survives the legal challenges and is not overturned by the U.S. Congress, it will result in many more (but not all) Americans being insured and will contain some costs through provisions that increase
efficiency. However, it is unlikely to stop overall costs from continuing to rise.
suMMarY
Skyrocketing costs and inequalities in the distribution of services are persistent problems in the U.S. health-care system. This, plus the prospect of greater government intervention, has stimulated rapid and sweeping changes in the way in which the health marketplace is organized. Managed-care enrollment has risen rapidly. Widespread concerns that small organizations will be unable to compete with large ones have been stimulating mergers and other alliances that can achieve economies of scale. Many of the problems are inherent in the system as it is organized today. Individuals can minimize some of their expenses through prudent consumer strategies. Insurance fraud and abuse are serious problems. Some frauds can be detected by examining insurance payment reports to see whether they accurately reflect the services rendered.
1. Everyone should have access to health care without financial or other barriers. 2. Guaranteed benefits should meet the full range of health needs, including primary, preventive,
and specialized care. 3. Each consumer should have the opportunity to exercise effective choice of providers, plans, and
treatments. 4. The system should provide care based only on differences of need, not financial status or other
individual or group characteristics. 5. Each individual and family should assume responsibility for protecting and promoting health and
contributing to the cost of care. 6. The health-care system should spread the costs and burdens of care across the entire community,
basing the level of contribution required of consumers on ability to pay. 7. Within a national framework, states and local communities should be able to design effective,
high-quality systems. 8. The system should respond to the unique needs of each stage of life, sharing benefits and burdens
fairly across generations. 9. The system should provide resources for the systematic evaluation of health-care outcomes so
that health care can be improved. 10. The amount spent on health care should be balanced against other important national priorities. 11. The system should have a democratic way to influence how it works and to resolve any disputes
that arise. 12. Paperwork and administrative red tape should be minimized. 13. The system should deliver high-quality care and provide individuals with the information neces-
sary to make informed choices. 14. Treatment policies should be determined with adequate input from clinicians. 15. Other (specify) ______________________
It’s Your Decision
Assume that you can influence the health-care delivery system for the United States. Rank the following possible characteristics of your system in order of importance.
______ ______
______
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Rank
Part Six Protection of the Consumer502
An ideal national health-care system would provide equity, access, efficiency, and quality. However, even though most people want “reform,” no plan has been able to satisfy the many competing interests.
reFerenCes
1. Davies NE, Felder LH. Applying brakes to the runaway Ameri- can health care system: A proposed agenda. JAMA 263:73–76, 1990.
2. Gramazon.com Web site, accessed July 21, 2005. 3. Angell M. Privatizing health care is not the answer: lessons
from the United States. Canadian Medical Association Journal 179:916–919, 2008.
4. National Coalition on Health Care. How Americans perceive the health care system: A report on a national survey. Journal of Health Care Finance 23(4):12–20, 1997.
5. Cromwell J and others. The Nation’s Health Care Bill: Who Bears the Burden? Waltham, Mass., 1994, Center for Health Economics Research.
6. Blendon R and others. Satisfaction with health systems in ten nations. Health Affairs 9(2):185–192, 1990.
7. Donelan K and others. The cost of health system change: Public discontent in five nations. Health Affairs 18:206–216, 1999.
8. National health expenditure tables, 1960–2009. Center for Medicare & Medicaid Services Web site, accessed Nov 22, 2011.
9. National health expenditure projections for 2010–2020. CMS Web site, accessed Nov 22, 2011..
10. Personal consumption expenditures by type of product (2009). Bureau of Economic Analysis Web site, accessed Aug 8, 2011.
11. Squires DA. The U.S. health system in perspective: A com- parison of twelve industrialized nations. Issues in International Health Policy, July 2011.
12. Public opinion and medical technology. Alexandria, Va., 1993, Health Care Technology Institute.
13. Shearer G. The health care divide: Unfair financial burdens. Washington, D.C., 2000, Consumers Union.
14. Davis JB, ed. Medical Fees in the United States: Nationwide Charges for Medicine, Surgery, Laboratory, Radiology and Al- lied Health Services. Los Angeles, 2010, Practice Management Information Corporation.
15. 2009 Survey of Dental Fees. Chicago, American Dental As- sociation, Dec 2009.
16. Hospital adjusted expenses per inpatient day, 2009. Kaiser State Health Facts Web site, accessed Aug 27, 2011.
17. The 2009 MetLife Market Survey of Nursing Home, Assisted Living, Adult Day Services, and Home Care Costs. Westport, Ct., 2009, MetLife Mature Market Institute.
18. Hagen S. Policy approaches to long-term care financing. In Fi- nancing Long-Term Care for the Elderly, Congressional Budget Office, April 2004.
19. Key issues in analyzing major health insurance proposals. Congressional Budget Office, Dec 2008.
20. Wenger MF, Shapiro NS. Rethinking utilization review. New England Journal of Medicine 333:1353-1354, 1995.
21. Glasson J and others. Ethical issues in managed care. JAMA 273:330–335, 1995.
22. Azevedo D. Will the states get tough with HMOs? Anti-man- aged care proposals pile up nationwide. Medical Economics 73(16):172–185, 1996.
23. Executive summary. Priorities for capitalizing on life-saving, cost-effective preventive services. Washington, D.C., 2006, Partnership for Prevention.
24. Harlow HJ. Some states are intervening on gag rule restrictions. State Bar of Texas Health Law Section Report, Winter 1997.
25. Shekelle PG and others. Costs and Benefits of Health Infor- mation Technology. Rockville, Md., Agency for Healthcare Research and Quality, April 2006.
26. Cuellar AE, Gertler PJ. How the expansion of hospital systems has affected consumers. Health Affairs 24:213–219, 2005.
27. Gabel JR and others. Self-insurance in times of growing and retreating managed care. Health Affairs 22:202–210, 2003.
28. Barrett S and others. Insurance fraud: How to spot a personal injury mill. Quackwatch Web site, July 24, 2002.
29. Santa J. How to haggle with your doctor. Consumer Reports Health, Sept 2011.
30. Morris L. Reducing fraud, waste, and abuse in Medicare. Tes- timony before the U.S. House of Representatives Ways and Means Committee, April 2011.
31. Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2010. Department of Health and Human Services and Department of Justice, Jan 2011.
32. Largest health care fraud case in U.S. history settled: HCA investigation nets record total of $1.7 billion. Department of Justice news release, June 26, 2003.
33. Doctor convicted of performing unnecessary surgeries on healthy patients in $154 million medical insurance fraud scheme. Orange County District Attorney Press Release, Aug 4, 2011.
34. Two men sentenced in one of the largest health insurance fraud cases ever prosecuted. Law Enforcement Report, Winter/Spring 1995, p 6.
35. Office of Inspector General. Semiannual Report, October 1, 1995—March 31, 1996. Washington, D.C., U.S. Department of Health and Human Services.
36. Houston medical equipment company manager sentenced to 120 months in prison and delivery driver sentenced to 41 months in prison for roles in Medicare fraud scheme. US Department of Justice news release, Nov 30, 2010.
37. Moriarty J, Quintana N. Cashing in by cashing out: Small Smiles and the corporate practice of America: A white paper. Moriarty-Leyendecker Web site, July 19, 2011.
38. Kusserow RP. Fraud alert: Routine waiver of co-payments or deductibles under Medicare Part B. Washington, D.C., 1991, U.S. Department of Health and Human Services.
39. Cohen RA and others. Insurance coverage: Early release of estimates from the National Health Interview Survey, 2010. National Center for Health Statistics. June 2011.
40. Schoen C and others. Insured but not protected: How many adults are underinsured? Health Affairs, June 14, 2005.
41. Potter W. Testimony before the U.S. Senate Committee on Commerce, Science and Transportation, June 24, 2009.
42. Hammond J. Why insurance reform is desperately needed. Insurance Reform Watch Web site, Sept 8, 2009.
42. Fein R. Prescription for change. Modern Maturity, July/Aug 1992, pp 22–35.
44. U.S. health care reform: Getting it done. Consumer Reports, March 2008.
45. Building a Better System: Specification for Reform. Washington, D.C., 2004, National Coalition on Health Care.
46. Woolhandler S and others. Proposal of the Physicians’ Work- ing Group for Single-Payer National Health Insurance. JAMA 290:798–805, 2003.
Chapter Twenty-Five
Consumer Laws, agenCies, and
strategies
All of us are exposed daily to many ideas about health, some of which are accurate and some not. . . . When you are well, unless you are taken in to an extreme degree, what you believe may not matter much. But if you have a health problem—particularly a serious one—misplacing your trust can seriously harm you or others who rely upon your judgment.
Stephen Barrett, M.D. Victor herBert, M.D., J.D.1
The basis of consumer protection. . . is to protect the buyer in societal circumstances which make him helpless, or put him on an unequal footing with the seller.
Warren G. MaGnuSon2
u.S. Senator, 1944–1981
When a situation can be solved with education, we will serve as the instructor. When a sterner approach is called for, we will be the cop.
Frank e. YounG, M.D., ph.D.3
FDa coMMiSSioner, 1984–1989
“More bad news from the FDA today: It seems that the flag, motherhood, and apple pie have all been found to contain cancer-causing agents.”
reprinteD FroM priVate practice
Part Six Protection of the Consumer504
The basic principles of consumer protection in health matters were outlined by President John F. Kennedy in a message to Congress in 1962.
Although Kennedy’s “Consumer Bill of Rights” had little immediate impact, it still provides a framework for future generations: People deserve to be provided with safe and effective foods, drugs, cosmetics, medical devices, and services by health-care practitioners. They must receive accurate information, through advertising and other media, that will enable them to make intel- ligent and free choices. Individuals have the right to speak out and be heard, to complain, and to know where to complain when they have been misled or exploited. Implementation of these rights requires five things:
1. Laws ensuring that health products are safe and effective and that health professionals are competent.
2. Government agencies that enforce the laws and keep the public informed.
3. Professional, voluntary, and business organizations that serve as consumer advocates, monitor government agen- cies that issue safety regulations, and provide trustworthy information about health products and services.
4. Education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information.
5. Action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.
Many agencies help to protect Americans in health matters. This chapter highlights the laws that control the two main federal consumer protection agencies: the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Information is also provided about other government agencies; voluntary, business, and professional groups; consumer education; and ac- tions that intelligent consumers can take to help protect themselves in the health marketplace. Additional trust- worthy sources of information and advice are listed in the
Appendix and on the Consumer Health Sourcebook Web site (www.chsourcebook.com). Federal enforcement ac- tions described in other chapters are listed under each agency in the Index. State and local actions are indexed under “Enforcement actions.”
u.s. Food and drug administration
The FDA is part of the U.S. Public Health Service, which is a component of the Department of Health and Human Services. The FDA’s main function is to protect the public from health hazards involving foods, drugs, cosmetics, and medical devices. Approximately 20¢ of every consumer dollar in the United States is spent on FDA-regulated products.4
The FDA sets performance standards; conducts in- spections, surveys, and analyses to measure compliance with these standards; evaluates drugs, biologics, and devices that require premarket clearance; initiates en- forcement actions when necessary; and helps inform and educate industry, health professionals, and the public. In fiscal year 2010 (October 1, 2009, through September 30, 2010), the agency had about 12,000 full-time equivalent employees and a budget of $3.2 billion.4
The FDA’s headquarters offices are located in the Washington, D.C., area and include the Office of the Commissioner, Center for Food Safety and Applied Nutrition, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Vet- erinary Medicine, Center for Devices and Radiological Health, and Center for Tobacco Products. Another com- ponent, the National Center for Toxicological Research, is in Jefferson, Arkansas. The FDA Commissioner is appointed by the president and confirmed by the U.S. Senate. The FDA’s Office of Regulatory Affairs directs inspections and enforcement policy. It is organized into five regions with 20 district offices and many field offices located throughout the country.
• Many health-related consumer-protection laws emphasize the importance of science and scientific testing.
• The government agencies that regulate products and professionals have significant regulatory powers but encounter far more problems than they can possibly handle.
• The best protection against fraud is a consumer who is informed, skeptical, and assertive.
Keep these points in mind as you read this Chapter
Key Concepts
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 505
Food and Drug Laws Many federal laws affect the marketing of health-related products. The principal laws are the following, listed in chronologic order. The original Pure Food and Drug Act (1906) was passed in response to public concern about the safety of foods and drugs (see Historical Perspective box). The act required that foods be pure and wholesome and that the ingredients of drugs be listed on their label. This law, initially administered by the Agriculture Department’s Bureau of Chemistry, did not require that drugs be safe or effective. In 1927 the act’s regulatory duties were transferred to the newly created Food, Drug, and Insecticide Administration, which was renamed Food and Drug Administration 3 years later. In 1940 the FDA became part of a new Federal Security Agency, which, in 1953, was elevated to cabinet status as the Department of Health, Education, and Welfare (DHEW). In 1979 DHEW became the Department of Health and Human Services (HHS). The Sherley Amendment to the Food and Drug Act (1912) prohibited the labeling of medicines with false therapeutic claims intended to defraud the purchaser. The Food, Drug, and Cosmetic (FD&C) Act (1938) replaced the 1906 law with new and stronger provisions:
• Foods in interstate commerce must be pure and wholesome, safe to eat, and produced under sanitary conditions.
• Drugs and therapeutic devices must be safe. • New drugs must be approved for safety by the FDA before
they can go on the market. (Products marketed before 1938 did not have to meet this requirement.)
• Cosmetics must be safe. • Labeling must be truthful and not misleading; common
names of all ingredients are required; quantities and pro- portions of potent and habit-forming narcotic and hypnotic substances must be given.
• Drug labeling must include warnings needed for safe use.
• Drugs not safe for self-treatment are restricted to sale by prescription.
• Drug-manufacturing plants must be registered and be in- spected by the FDA at least once every 2 years.
• Antibiotics, insulin, and colors used in foods, drugs, and cosmetics must be tested in FDA laboratories before they can go on sale.
• Chemicals added to foods must be proven safe before their use is allowed.
• Pesticide residues in or on raw crops must not exceed safe tolerances. (The Environmental Protection Agency now establishes the limits, and the FDA enforces them.)
• Penalties are heavier for second offenses and fraud. First offenses might bring up to 1 year in jail.
• The FDA no longer had to prove that defendants intended to defraud their customers. This was important because some promoters are misguided cranks who believe in their products.
The Public Health Service Act (1944) contained two sections now enforced by the FDA. Their provi- sions cover the safety, purity, and potency of biologic products, such as vaccines, sera, and blood for interstate sale, and the safety of pasteurized milk and shellfish, as well as the sanitation of food, water, food services, and facilities for travelers on trains, airplanes, and buses. The Durham-Humphrey Amendment (1951) speci- fied that drugs that cannot be safely used without medi- cal supervision must be so labeled and be dispensed only by prescription of a licensed health practitioner. Thus a distinction was made between over-the-counter (OTC) and prescription drugs. Before this law took ef- fect, manufacturers decided whether to classify drugs as prescription or OTC. If the FDA disagreed, it could bring the case to court and charge that the product was misbranded. The Food Additives Amendment (1958) prohibited the use of new food additives until the manufacturer had established their safety. Its Delaney Clause gave the FDA additional authority to ban the use of food additives that can cause cancer in humans or animals. The Color Additive Amendments (1960) permitted the FDA to regulate the conditions for the safe use of color additives in foods, drugs, and cosmetics and to require manufacturers to make the necessary scientific investigations to establish safety. The Federal Hazardous Substances Labeling Act (1960) required that labels display prominent warnings regarding household products with hazardous chemicals. This is now enforced by the Consumer Product Safety Commission. The Kefauver-Harris Drug Amendments (1962) overhauled and strengthened the drug provisions of the FD&C Act of 1938. They came about as a result of the foresight of Dr. Frances Kelsey, an FDA medical officer who prevented the release of thalidomide on the U.S. market because of suspected side effects (see Historical Perspective box). Strong public support for strengthening the law resulted from news reports about deformed Ger- man babies whose mothers had taken thalidomide during their pregnancy. These 1962 amendments included the following provisions: • Manufacturers must provide substantial evidence that a new
drug is effective as well as safe before it can be approved for marketing.
Part Six Protection of the Consumer506
The Pure Food and Drug Act (1906) was passed in response to public concerns about the safety of foods and drugs. After the Spanish-American War it was discovered that the army had been supplied with spoiled canned meat and sawdust-adulter- ated flour. There were also reports that toxic chemicals such as formaldehyde had been used to preserve milk sold in neighbor- hood grocery stores. Two leaders in the struggle to enact the bill were Dr. Harvey W. Wiley, chief chemist for the Department of Agriculture, and his crusading journalist follower, Samuel Hopkins Adams. Wiley’s main concern was the prevalence of fraudulent food products, but he also fought hard for the regula- tion of patent medicines. Wiley believed that all remedies should have their formula on the label and that none containing alcohol or cocaine should be sold without a doctor’s prescription. In 1905 Collier’s Weekly magazine began a series of 10 articles by Adams titled “The Great American Fraud.” The series attacked nostrum evils and quackery and said that Americans were wasting more than $75 million annually on products con- taining large quantities of alcohol, opiates, and other question- able ingredients. He noted, for example, that Dr. King’s New Discovery for Consumption, which had been proclaimed as the world’s only sure cure for tuberculosis, contained morphine, chloroform, and 28% alcohol. The chloroform was to allay the cough while the morphine and alcohol drugged the patient into deceptive cheerfulness. The label did not reveal the nature of the ingredients or their possible hazardous effects. Adams explained that patent medicine testimonials were gathered from gullible ignoramuses or secured through various pressures from people in public life.5 The American Medical Association reprinted his articles as a 172-page booklet and sold nearly 500,000 copies, many of which were distributed by physicians to their patients. The final impetus to passage of the act was Upton Sinclair’s novel The Jungle, which was published near the end of 1905. Sinclair was a socialist who railed against American capitalism. His book was aimed at exposing the exploitation of immigrant laborers who were often forced to work long hours at low pay. The setting for his fiction was the meat-packing industry, where, said the book, rats, human fingers, and even whole bodies were processed along with animal parts into sausage and lard. There was no truth in such claims, but the public reacted with outrage—not at the exploitation of immigrants as Sinclair had intended, but at the imaginary conditions he described.6
Truth in Labeling The Pure Food and Drug Act required that medicine labels tell the truth, but not the whole truth. Labels had to indicate the presence and amount of alcohol, opiates, acetanilide, and several other potentially dangerous substances. It was not necessary to identify other ingredients. The label could not provide false or misleading statements about the medicine or its ingredients. The new law did not inhibit self-medication but attempted to make it safer. It was assumed that the average person was intelligent enough to avoid risks when ingredients were known. Products were not required to be effective. Many product labels changed drastically after 1906. When the law was violated, the government occasionally went to court,
where it usually would prevail. However, fines were usually $50 or less, sometimes as low as one cent. The first court trial under the Pure Food and Drug Act was brought against Cuforhedake Brane-Fude, a product that contained acetanilide (an analgesic and antipyretic), antipyrine, caffeine, sodium and potassium bromide, and alcohol. The label stated that the product contained 30% alcohol and 16 grams of acetanilide, but Wiley’s analysis revealed only 24% alcohol. The product was claimed to offer “a most wonderful certain and harmless relief” and to contain “no . . . poisonous ingredients of any kind.” The government charged that this was misleading. Wiley noted that the product’s name appeared to be an evasive spelling for a headache cure and that none of the ingredients was food for the brain. One of Adams’s magazine articles had identified 22 headache-remedy users alleged to have had died from acetanilide poisoning. The manufacturer was found guilty of misbranding, fined $700, and forced to relabel the product. Some 2 million bottles had been sold for $1 each before the 1908 verdict. This illustrates how the selling of a quack remedy can be extremely profitable despite government enforcement action—a situation that holds true today. Although Cuforhedake Brane-Fude is no longer with us, products named after an ailment, body part, or body function are still abundant.
Truth in Advertising The Pure Food and Drug Act had little effect on misleading advertising. In 1911 the Supreme Court ruled that the act’s prohibition against false labeling did not apply to therapeutic claims, because the misbranding section of the law did not explicitly refer to curative promises. Congressman Swager Sherley of Kentucky sought to correct this problem by obtaining passage in 1912 of an amendment stating that an article would be misbranded “if its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein which is false and fraudulent.”6
By 1915 the food and drug laws still had not controlled the problem of false and misleading advertising of patent medicines. Observers who claimed that conditions had worsened noted that: the job was too big for a small regulatory staff; fines were small and often unpaid; second offenders could be sent to jail for 1 year, but none had ever been sent; many dangerous drugs were not covered by the law; and newspaper advertisements were still misleading.
Safety Requirements Added In 1938 the Food, Drug, and Cosmetic Act replaced the 1906 law with new and stronger provisions. As with the original law, public indignation was aroused by a book, 100 Million Guinea Pigs, by Arthur Kallet and F.J. Schlink. (The book’s title referred to the U.S. population at that time.) Several trag- edies had occurred, but the most outrageous was the mounting death toll from elixir of sulfanilamide, a product sold over the counter for treating infections, especially gonorrhea. It was the first antibiotic drug and at first was considered a miracle drug. Unfortunately, it contained the toxic substance diethylene glycol
Historical Perspective
A Brief History of Federal Consumer Protection Laws
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 507
Historical Perspective
A Brief History of Federal Consumer Protection Laws—Cont’d.
and had not been tested for safety. In 1937, 107 people, many of them children, died. The 1938 law increased public protection but did not clearly distinguish between drugs requiring medical supervision and those suitable for self-medication. New drugs would have to be proven safe before marketing, but proof of effectiveness was still not required. The hazard of permissive refills of prescribed drugs also remained. In the Midwest, a mother of three children was discovered upon admission to a hospital to be a barbiturate addict. She had received a prescription for 30 capsules that had been refilled 16 times within 3 months. Another woman with mild high blood pressure was found dead in her bed. During the preceding 6 months she had received 23 refills of a prescription for 20 bar- biturate capsules. Such evidence led to passage in 1951 of the Durham-Humphrey Amendment, which prohibited the refilling of prescriptions without specific authorization of the physician. It also gave the FDA the power to classify drugs as prescription drugs. Young7 called the 25-year period following passage of the 1938 Act “the chemotherapeutic revolution.” Its impact on self-medication was enormous. Americans spent less than $200 million per year for nonprescription medications in the 1930s, but by 1957 the sum had reached $2 billion. (Today it is more than $19 billion.) This increase was partially due to extensive advertising. Unscrupulous promoters of pseudomedicine were prevalent during this period and their appeals became more sophisticated. Promotions included pamphlets, newspapers, roadside signs, lecturers (some speakers collected $25,000 weekly from fees and sales), and door-to-door salespeople. Critics charged in 1961 that the chemotherapeutic revo- lution had produced a therapeutic nightmare, especially with respect to prescription medications. Although many new drugs could save lives and reduce pain and suffering, many were improperly used, and drug-induced ailments occurred with increasing frequency. Some blame was attributed to physicians because (a) drugs were sometimes prescribed when none was needed, (b) new therapeutic agents were sometimes used with- out considering their potential dangers, and (c) physicians at times relied too much on the claims of drug manufacturers and salespeople.
Efficacy Requirements Added . . . and Partly Waived The marketing of thalidomide as a sleeping tablet, sedative, and antiemetic for pregnant women began in West Germany in 1957. Three years later, the manufacturer sought permission to sell it within the United States by submitting a new drug application to the FDA. But Dr. Frances O. Kelsey, an FDA physician, suspected that the drug was hazardous to the unborn child. As a result of her action, the application was withdrawn. It soon became clear that babies born to mothers who took thalidomide during pregnancy had a high incidence of serious birth defects of their arms and legs. The drug was never marketed in the United States, but some Americans obtained it in Europe. The thalidomide tragedy led to passage in 1962 of the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act. It provided that no new drug could be released to the public
unless the manufacturer provided evidence acceptable to the FDA that the drug was effective as well as safe. Drug companies also had to notify the FDA whenever they became aware that an approved drug might have adverse effects. Prior to passage of this law the FDA bore the burden of proving ineffectiveness. The Dietary Supplement Health and Education Act of 1994, passed in response to an aggressive campaign by the health-food industry, weakened the FDA’s ability to protect consumers from misleading promotions for vitamins, minerals, amino acids, herbs, and various other substances marketed as “dietary supplements.” Postal Laws The Mail Fraud Statute (1872) was enacted to combat a rash of swindles that had erupted after the Civil War. Prior to passage of this law, con artists who used the mail to defraud people were virtually safe from prosecution because local law-enforcement officials were unable to obtain jurisdiction over distant swindlers. By 1895 the Postal Service could stamp letters “fraudulent” and return them to senders, but it was not until 1901 that the Postmaster General, with Dr. Wiley’s help, began acting against patent-medicine frauds. Postal authorities assailed the most outrageous quacks who promised sure cures for such problems as cancer, consumption (tuberculosis), epilepsy, blindness, deaf- ness, a drug habit, a tobacco habit, “lost manhood,” and “failing womanhood.” Proving fraud was easiest against devices said to restore lost manhood or cure all human ills. During the 1920s, frauds involving nostrums for tuberculosis and venereal disease were common. Most current health-related mail frauds involve “miracle” diets and products claimed to enhance beauty, sexual function, or athletic prowess. The Mail Order Consumer Protection Amendments of 1983 enable the Postal Service to seek large civil penalties for repeat offenders. This law was passed after Consumer Reports publi- cized an investigation by Dr. Stephen Barrett that demonstrated that almost every health-related product sold by mail through magazine advertising was misrepresented.8 Before that time, swindlers could remain in business indefinitely by modifying products, making new advertising claims, or operating under new company names. Unfortunately, the agency has not tried to stop false advertising of any health product since 1991. FTC Laws The Federal Trade Commission Act (1914) was intended to preserve competition in the growing industrial society by pro- viding safeguards against business monopoly. It was designed to prevent unfair methods of competition in commerce by making unfair practices unlawful, thereby protecting consumers as well as other entrepreneurs. The FTC was given authority to investigate, publicize, and prohibit such procedures. The first five commissioners were sworn into office in 1915. The Wheeler-Lea Amendment (1938) provided for regulation of advertising of all health-related products except prescription drugs. The Fair Packaging and Labeling Act (1966) gave the FTC primary jurisdiction over package and label claims in all areas except food, drugs, devices, and cosmetics, which are still delegated to the FDA.
Part Six Protection of the Consumer508
• Previously cleared new drugs may be ordered off the mar- ket immediately if new information indicates an imminent hazard to health, and any prior approval may be withdrawn.
• Manufacturers are required to get the patient’s consent if experimental drugs are to be used, unless this is not feasible or the investigator believes that obtaining such consent would be contrary to the patient’s best interest.
• All drug products must be registered annually with the FDA, and each establishment will be inspected at least once every 2 years.
• The FDA was given broad inspection authority over pre- scription drugs.
• Prescription drug advertisements must include a summary of side effects, contraindications, and effectiveness.
• All drug labels must bear the established generic name of the drug, and prescription drug labels must list the quantity of each active ingredient.
• Regulatory authority over the advertising of prescription drugs was passed from the FTC to the FDA. (The FTC still has regulatory authority over OTC drugs.)
• Pharmaceutical manufacturers must comply with the Code of Good Manufacturing Practices in testing, processing, packaging, and holding drugs.
The Drug Abuse Control Amendments (1965) were enacted to control the manufacture and distribution of depressants, stimulants, and hallucinogens. The amend- ments required wholesalers and jobbers of these drugs to register annually with the FDA. The agency was also authorized to seize illegal supplies, serve warrants, ar- rest violators, and require all legal handlers of controlled drugs to keep records of their supplies and sales. A new Bureau of Drug Abuse Control (BDAC) was established for these purposes. In 1968, to consolidate the policing of illegal drug traffic, BDAC was transferred from the FDA to the new Bureau of Narcotics and Dangerous Drugs in the Department of Justice (now called the Drug Enforcement Administration). The Fair Packaging and Labeling Act (1966) pro- vided additional support for the FDA to ensure that food, drugs, medical devices, and cosmetics were honestly and informatively labeled. It required more complete information on labels and packages. The information was to be clearly and prominently stated in terms that would enable consumers to make value comparisons between competing products. Food package labels were required to contain the identity of the food; the name and address of the manufacturer, packer, or distributor; the net quantity of the contents; and an ingredient list. The FTC retained jurisdiction over OTC drug advertising. The Radiation Control for Health and Safety Act (1968) was designed to protect the public from unnec- essary exposure to radiation from electronic products such as color television sets, microwave ovens, and
x-ray machines. The FDA sets performance standards for these and similar products. The Poison Prevention Act (1970) required special packaging to protect children from accidentally ingesting toxic substances. Poisons identified by the Secretary of Health, Education, and Welfare must be packaged so that most children younger than 5 will find them difficult to open. The Medical Device Amendments (1976) supple- mented the 1938 FD&C Act, which permitted action only if a defect in a product was discovered after the product was in use. The amendments gave new authority over the safety and effectiveness of devices. They enabled the FDA to require premarket approval for some items and performance standards for others. The Proxmire Amendment (1976) prohibited the FDA from limiting the potency of ingredients of vitamin and mineral products that are not inherently dangerous. This bill prevents the FDA from ridding the marketplace of useless “dietary supplement” ingredients and irrational combinations of ingredients. The bill was passed because the health-food industry misled many of its customers into believing that the FDA intended to greatly restrict the sale of supplement products. More than 1 million protest messages poured into Congress as a result. The Infant Formula Act (1980) requires strict controls to ensure the nutritional content and safety of commercial baby foods. The Orphan Drug Act (1983) was passed to facilitate the development of new drugs for more than 5000 rare diseases affecting as many as 20 million Americans. A disease is considered “rare” if it affects fewer than 200,000 people. Drug companies can now claim half of clinical trial costs as a credit against taxes owed. Compa- nies might otherwise be reluctant to develop such drugs and gain FDA approval because the cost is prohibitive. The legislation also authorized grants to fund research to discover useful substances. Following approval the manufacturer is entitled to 7 years of marketing exclu- sivity. So far, more than 350 orphan products have been approved.9
The Drug Price Competition and Patent Term Res- toration Act (1984) permits the FDA to approve generic versions of previously approved new drugs without requiring their sponsors to duplicate the costly human tests required for the original drugs (see Chapter 17). It allows the term of patents on medicines (17 years) to be extended up to 5 years to compensate for the time required to get FDA approval. The Prescription Drug Marketing Act (1988) pro- hibits selling; buying; trading; or offering to sell, buy, or trade prescription drug samples.
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 509
The Safe Medical Devices Act (1990) gave the FDA the power to (a) obtain earlier knowledge of serious device problems, (b) order recalls to quickly remove defective products from the marketplace, (c) track de- vices from the manufacturer to the consumer, and (d) apply large civil penalties for violations of the act. The act requires hospitals and other health-care providers to report device-related deaths directly to the FDA instead of to the device manufacturer. Additional provisions are discussed in Chapter 20. The Nutrition Labeling and Education Act (1990) provided for (a) mandatory labeling on most food products; (b) standardization of portion sizes; (c) more appropriate disclosure of fat and cholesterol contents; (d) determination of whether disease-prevention claims can be made for various nutrients; and (e) voluntary guidelines to retailers for nutrition information on raw fruits, vegetables, and fish. Chapter 10 discusses how these provisions have been implemented. The Dietary Supplement Health and Education Act (DSHEA) of 1994 was passed following a massive lobby- ing campaign by the health-food industry. (See Chapter 11.) This law (a) broadened the term “dietary supple- ments” to include herbs and many other substances that lack nutritional value, (b) shifted the burden of proof of safety on the FDA, (c) set standards for the distribu- tion of third-party literature, (d) allows statements of “nutritional support” under certain circumstances, (e) specified the ingredient and nutritional label informa- tion, (f) requires good manufacturing practices, and (g) established the NIH Office of Dietary Supplements to oversee research and provide advice to other federal agencies. DSHEA greatly weakened the ability of the FDA to protect consumers against unsubstantiated claims made in product labeling or advertising.10 Final regula- tions covering the law’s requirements for supplement labeling, health claims, and “statements of nutritional support” took effect in 2000.11
The Food Quality Protection Act (1996) replaced the Delaney Clause (see page 505) with a more flexible requirement that additives be safe (defined as “reason- able certainty” that no harm will result from their use). The FDA Modernization Act (1997) codified or extended regulations intended to (a) accelerate review of new drugs and devices, (b) increase patient access to experimental drugs and devices, and (c) permit pharma- cists to compound certain categories of drug products not commercially available.
Food, Drug, and Cosmetic Act The Food, Drug, and Cosmetic Act, including amend- ments, is the primary federal consumer protection law
in the United States.12 It deals with imported products as well as domestic ones. Its purpose is to ensure that foods are safe to eat, drugs and health devices are safe and effective for their intended uses, and cosmetics are safe and properly labeled. The following are its main provisions. Food provisions. Food is considered adulterated if it contains (a) poisonous or deleterious substances that are injurious to health; (b) filthy, putrid, or decomposed substances or substances prepared and packed under unsanitary conditions; or (c) unsafe color additives. Food is said to be misbranded when: (a) the label- ing is false and misleading; (b) the food is offered for sale under the name of another food; (c) the food is an imitation of a food and the label does not bear the word “imitation”; (d) the container is so made, formed, or filled as to be misleading about its contents; (e) the food is represented for special dietary use without the label bearing information about the product’s vitamin, min- eral, and dietary properties; (f) the food contains artificial flavoring, artificial coloring, or chemical preservatives that are not listed on the labels; or (g) the labeling is not conspicuously displayed in terms that consumers are likely to read and understand. Regulations that took effect in 1994 require manu- facturers to provide nutrition information on product labels. The required nutrition panel must state the typical serving size, the amounts per serving of several impor- tant nutrients, and Percent Daily Values that indicate how the food fits into the overall diet of people at specified calorie levels. The regulations also permit health claims to be made for certain types of food. Chapter 11 covers the new labeling regulations in detail. Food additives. Additives must be supported by evidence substantiating their safety before they may be included in a product. The Food Additives Amendment of 1958 authorized the FDA to establish the quantities of certain substances that could be added safely. The FDA categorizes additives either as regulated food additives or as GRAS (generally recognized as safe) substances. Several thousand compounds can be classified as additives. Regulated food additives are substances that can be added directly to food (such as vitamins to milk or bread) or that get into food from its surroundings, including packaging, manufacturing equipment, and other sources. The GRAS list includes about 700 additives that scientists recognize as safe be- cause of long-established use without evidence of harm to individuals. Many additives come from food itself. Lecithin, for example, is found in all plants and animals. It is obtained primarily from soybeans and is used mostly
Part Six Protection of the Consumer510
as an emulsifier to keep ingredients in processed foods from separating. Calcium and sodium propionate are used in the cheese industry, but propionate also occurs naturally in Swiss cheese. Propionate is used primarily as a mold inhibitor in baked goods. Sodium benzoate prevents mold growth in margarine. Added vitamins and minerals are identical to those found naturally in food. Food additives are used as (a) nutrient supplements (such as vitamins and minerals used for enrichment or fortification), (b) nonnutritive sweeteners (sugar substi- tutes), (c) preservatives (to prevent microbial spoilage and oxidative chemical change), (d) stabilizers and thickeners (as in ice cream, candy, frozen desserts, jams, jellies, and gelatin), (e) flavors or flavoring agents (such as spices, liquid derivatives of onion and garlic, and the flavor enhancer monosodium glutamate made from corn, beets, or soybeans), (f) bleaching and maturing agents (which speed the aging process of flour), and (g) colors. There are other functional uses, and several additives serve more than one purpose. Ascorbic acid (vitamin
C), for example, is a nutrient, an acidifying agent, an antioxidant, and a microbial inhibitor. Any new substance proposed for addition to food must undergo rigid testing. The FDA also requires information about the chemical composition of the sub- stance, how it is manufactured, and the methods used to detect it and to measure it at the expected levels of use. Data must show that the proposed testing methods are sensitive enough to determine compliance with estab- lished regulations. Finally, proof must be provided that the substance is safe for its intended use. This requires tests that administer the additives in various concentra- tions in the diets of two or more species of animals. The FDA will allow the use of a food additive only if it concludes there is practical certainty that no harm will result from its normal use over a lifetime. In recent years, the FDA has been concerned about the addition of caffeine to alcoholic beverages (see Per- sonal Glimpse box). Food irradiation. Irradiation (sometimes called “cold sterilization”) can make food safer by killing harmful pathogens, spoilage microorganisms, para- sites, and insects and can also extend the shelf-life of fruits, vegetables, and certain other foods by retarding enzymatic spoilage. The FDA regulates food irradiation as an additive, even though it does not “add” anything to food. The process is accomplished by treating foods with ionizing radiation (gamma rays) from radioactive cobalt or cesium or from devices that generate electron beams (beta rays) or x-rays. During the 1960s irradiation was approved for use on potatoes to control sprout growth and for insect disinfestation of wheat and wheat flour. Later it was approved for pork (1985), herbs, spices, fresh fruits, and dry vegetable substances (1986), meat and poultry products (1990, 1992, 1995, 1997, 2000), fresh shell eggs (2000), and seeds for sprouting (2000). Irradiation can kill Salmonella bacteria in poultry and trichinosis organisms in pork and can retard spoil- age of fruits and vegetables. Extensive studies indicate
Figure 25-1. International food irradiation symbol.
Personal Glimpse
FDA Attacks Caffeinated Alcohol Drinks13
Caffeinated alcoholic beverages (CABs) are alcoholic beverages that contain caffeine as an additive and are packaged in combined form. Caffeine can mask sensory cues that people may rely on to determine how intoxi- cated they are. This means that people drinking these beverages may consume more alcohol and become more intoxicated than they realize. Studies suggest that drinking caffeine and alcohol together can lead to hazardous behaviors, including alcohol poisoning, sexual assault, and riding with a driver who is under the influence of alcohol. Malt versions of premixed alcoholic beverages come in containers holding between 12 and 32 liquid ounces. Some may also contain stimulant ingredients in addition to caffeine. Their advertised alcohol-by- volume value is as high as 12%, compared to standard beer’s usual value of 4 to 5%. These beverages are available in many states in convenience stores and other outlets. They often come in large, boldly colored cans comparable in size to “tall” cans of beer—or in containers resembling regular beer bottles. In November 2010, theFDA notified four compa- nies that make malt versions of these beverages that the marketing of these beverages is illegal because, under the law, the added caffeine is an “unsafe food additive.”
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 511
that foods exposed to low doses of irradiation are safe to eat.14 The foods do not become radioactive or undergo significant changes in nutrient composition. Some irradi- ated foods have better flavor and texture than their heat- treated counterparts because, unlike heating, irradiation does not cook the foods. Irradiation is also used to steril- ize medical instruments and to prepare special foods for astronauts, military personnel, and cancer patients with impaired immunity. Since 1986 the labels of irradiated foods have been required to carry the internationally used logo of the stylized rose with two petals (Figure 25-1). Genetically engineered foods. The FDA’s policy for genetically engineered foods covers all foods produced by any method of plant breeding. Although GRAS sub- stances are excluded from the requirement for premarket approval, new substances introduced via breeding must be approved as food additives. Genetically engineered food crops that do not contain substances significantly different from those already in the diet do not require ap- proval as food additives, but they are required to undergo extensive testing for quality and safety. These products are also referred to as genetically modified organisms (GMOs). So far, more than 40 genetically modified crops have been FDA-approved. The FDA has also approved the use of bovine somatotropin (BST), a genetically engineered animal growth hormone that increases milk production in cows. Genetically engineered BST, which supplements the cow’s natural supply, does not alter the milk and presents no health risk to consumers.15 Since there is no detectable difference in milk from treated and untreated cows, the FDA does not require that products from treated cows be labeled. In 2004, the National Academy of Sciences16 published extensive guidelines for continuing to monitor safety but noted no adverse health effects attributed to genetic engineering had been documented in humans.
Food irradiation and genetic engineering have been unfairly attacked by the health-food industry, the “or- ganic” food lobby, food faddists, and several “consumer” groups (Figure 25-2). The Foundation for Economic Trends, for example, which refers to genetically engi- neered foods as “Frankenfoods,” erroneously claims that milk produced with BST will contain “artificial hormones” that “could be hazardous to our health and our children.” A few restrictive state laws have been en- acted, and boycott threats by radical consumer activists have made some manufacturers and retailers reluctant to market foods produced with these technologies. Drug provisions for humans. The FD&C Act pro- hibits misbranding and adulteration of any drug. Drugs are categorized as new, investigational, prescription, or nonprescription:
neW DruGS are any drugs that (a) contain a newly developed chemical, (b) contain a chemical or substance not previously used in medicine, (c) have previously been used in medicine but not in the dosages or conditions for which the sponsor now recommends use, or (d) have not been recognized by experts as safe and effective for their intended use. It is illegal to introduce a new drug into interstate commerce without FDA approval. Approval is sought by filing a new drug application (NDA) containing acceptable scientific data that demonstrate safety and efficacy.
inVeStiGational neW DruGS are new drugs intended solely for research use by experts who are qualified by training and experience to investigate the drugs’ safety and effective- ness. Their use is permitted under regulations established by the FDA.
preScription DruGS may be dispensed only when prescribed by a licensed health professional.
nonpreScription (otc) DruGS are those considered safe for consumer use when label directions and warnings are fol- lowed.
Imported drugs must comply with FDA provisions. New drugs approved in other countries must still undergo the FDA’s NDA procedure here. The labeling of a drug must include:
• The name and address of the manufacturer, packer, and shipper
• The strength and quantity • The active ingredients • An expiration date • A warning if a habit-forming substance such as codeine is
used • The quantity of ingredients such as alcohol and ether • The established name and trade name clearly identified • If a prescription drug, a caution that the drug may be dis-
pensed only by prescription • Adequate directions for use, including conditions of use,
dosage, frequency, and time of administration
Figure 25-2. Bumper sticker and decal distributed by groups organizing unwarranted boycotts of irradiated and genetically engineered foods.
TELL THE FDA DON’T NUKE MY FRUIT
Part Six Protection of the Consumer512
• Adequate warnings, when necessary, to protect the user • No false or misleading statement
Other drug provisions of the FD&C Act include:
• Drugs must not consist of filthy, putrid, or decomposed substances.
• Drugs must not be dangerous to health when used as di- rected by the label.
• Nonofficial drugs (those not in any of the official compen- dia) are considered adulterated if their strength differs from or their purity or quality falls below that which they claim to possess.
• Manufacturers may not ship prescription drugs directly to the public. They may be sent only to firms that are regularly and lawfully engaged in the wholesale or retail distribution of prescription drugs or to hospitals, clinics, physicians, or others who are licensed to prescribe such drugs.
• The official drug compendia are The United States Phar- macopeia (USP), which includes the National Formulary (NF), and the Homeopathic Pharmacopeia of the United States. By law, all substances in these references must meet the standards of strength, quality, and purity they set forth.
Clinical testing of drugs. Before a new drug can be approved and marketed, the manufacturer must submit substantial evidence of safety and efficacy. Manufactur- ers generally must take the following steps:17,18
• The drug must be subjected to laboratory and animal tests, which must indicate that it can be safely tested in humans.
• Before the drug is given to people, the sponsor must submit a “Notice of Claimed Investigational Exemption for a New Drug,” which is commonly referred to as an “IND.” The application must describe the composition of the substance, the results of the animal studies, the design (protocol) of the proposed clinical trial, the measures that will protect the experimental subjects, and the training and experience of the investigators.
• Approved clinical investigations follow three phases: Phase I—About 50 people are exposed to the drug to de-
termine the toxicity, metabolic absorption and elimination, and other pharmacologic reactions; the preferred route of administration; and the safe dosage.
Phase II—Initial trials are conducted on a small number of people for treatment or prevention of the specific disease. Additional animal studies to indicate safety may be con- ducted concurrently.
Phase III—Extensive clinical trials take place if Phases I and II demonstrate reasonable assurance of safety and effectiveness, suggesting that the drug’s potential value outweighs its possible hazards.
• The manufacturer submits an NDA together with all the data collected plus a sample of the package insert and the proposed label.
• The FDA approves the NDA, asks for further evidence, or rejects the application.
• The FDA can withdraw approval of a drug found to pro- duce unexpected side effects or to be less effective than anticipated.
The FDA drug approval process usually takes several years and has been criticized for delaying the speed with which beneficial new drugs can be marketed. On the other hand, some authorities have expressed concern that speeding up the process may weaken protection against unsafe and ineffective drugs. Sidney Wolfe, M.D.,19 who has criticized the agency for occasional lapses, has stated that “the FDA does a better job of protecting the public from unsafe foods, drugs, medical devices, or other products that it regulates than any other such agency in the world.” In response to the AIDS crisis, the FDA established regulations permitting promising investigational new drugs to be used outside of clinical trials to treat serious or life-threatening conditions when no satisfactory alternative is available.20 In 1972 the FDA began the enormous task of review- ing approximately 300,000 OTC products for safety and efficacy (see Chapter 17). Because the number of drugs was so large, the agency decided to investigate the ingre- dients according to categories rather than each product individually. Each group of drugs was investigated by an expert panel. As the panel reports were issued, many manufacturers reformulated their products by removing ingredients judged unsafe or ineffective and/or adding effective ones. Final rules have been issued for about 90% of the categories,21 but most of the remaining OTC products are safe and effective for their intended purposes. Device provisions. Before passage of the 1976 Medical Device Amendments, any device could be sold to the public provided it was properly labeled. If the de- vice needed the supervision of a licensed practitioner, the label had to caution that use was restricted. A prescription device could be shipped to a licensed practitioner but not to the patient unless ordered by the practitioner. A device became illegal if it was dangerous to the health of consumers when used as prescribed or suggested on the label. Labels had to contain adequate directions and include warnings to ensure safe use. Despite these rules, many worthless, ineffective, or dangerous products were marketed. The 1976 amendments enabled the FDA to require that existing devices be safe and effective and that new ones be safe and effective before marketing. The 1990 Safe Medical Devices Act strengthened the FDA’s ability
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 513
to monitor the marketplace, order recalls, and initiate large civil penalties for violations of the act (see Chapter 20 for details). Cosmetic provisions. Cosmetic preparations dis- tributed in the United States are required to comply with the cosmetic provisions of the FD&C Act and the Fair Packaging and Labeling Act. Cosmetics offered to pre- vent or cure ailments or to affect the structure and func- tion of the body are subject to the act’s drug provisions. Such products include antibiotic deodorants; hormone creams; and products claimed to remove wrinkles, cure skin diseases, or treat or prevent dandruff. Products must not be injurious to the skin when used as directed on the label. Hair dye preparations that contain skin irritants are an exception. These may be marketed for use as hair dyes if the label bears this statement:
CAUTION: This product contains ingredients which may cause skin irritation on certain individuals, and a preliminary test according to accompanying directions should first be made. The product must not be used for the dyeing of eyelashes or eyebrows, which may cause blindness.
The labeling must contain adequate directions for making the preliminary test. Color additives used in cosmetics must be approved as safe and certified by the FDA. No coal tar dye is cer- tified for use around the eyes. Containers must not be composed of harmful substances. False and misleading statements are not permitted on labels.
Enforcement Actions During fiscal year 2008, FDA investigators inspected about 15,000 companies in the United States and a few hundred abroad. When a food, drug, device, or cosmetic product is defective or hazardous to human health or violates FDA regulations, the FDA can ask the manu- facturer to correct the situation. Usually the request will lead to a voluntary recall or correction of faulty labeling. If a manufacturer does not comply, the FDA can seek a court order authorizing seizure of the product. A U.S. marshal will then be directed to take possession of the goods until the matter is resolved. When products are marketed with improper claims, the FDA may issue a warning letter that specifies the law violations and demands to know how the problem will be corrected. If the letter is ignored or if the FDA decides to begin with more forceful action, the agency can initiate court proceedings for a seizure, injunction, or criminal prosecution. Thousands of warning letters are posted on the FDA’s Web site. If a product is seized, it may be returned to its owner if its labeling can be corrected. If a product is basically
unfit to market or if its owner does not contest the seizure, the court will order it destroyed. Injunctions are court orders that tell individuals or companies to discontinue illegal practices (such as marketing drugs that lack FDA approval as safe and effective). If an injunction is violated, the court has considerable discretion in deter- mining the punishment and can order imprisonment or a large fine. Recalls and seizures are listed in the agency’s weekly online Enforcement Report. In criminal cases, first-time violators of the Food, Drug, and Cosmetic Act can be imprisoned up to 1 year, and repeat offenders can be imprisoned for up to 3 years. The 1984 Criminal Fine Enhancement Act amended all federal criminal laws to allow fines of up to $100,000 (or $250,000 if death results) per offense for up to two offenses. During fiscal year 2008 there were 445 warning letters, 2721 product recalls, 8 seizures, 5 injunctions, 17,907 import refusals, and 369 criminal convictions that resulted in more than $860 million in fines and restitution.22 The FDA does not routinely issue statistics indicating how many of its enforcement actions involve
Personal Glimpse
Internet-Based Quackery Stopped
For several years a New-York-based company called Christian Brothers used unsolicited (“spam”) mes- sages to sell apricot seeds with claims that they will completely prevent cancer and can cause cancers to shrink and become harmless. Apricot seeds contain amygdalin, a cyanide-containing compound that has been promoted as a cancer remedy (Laetrile) for many years (see Chapter 16). Court documents indicate that the company un- lawfully obtained e-mail addresses of America Online (AOL) members and used AOL’s computer networks to send more than 20 million messages—at times sending hundreds of thousands of messages per hour. Messages were also distributed through other channels. The mes- sages provided links to several Web sites containing testimonials. AOL sued the company and its president, Jason Vale, and in 1999, was awarded $651,685 for damages and attorneys’ fees. In 2000, acting on the FDA’s behalf, the Justice De- partment obtained a permanent injunction prohibiting Vale and Christian Brothers from making or distributing amygdalin, Laetrile, or apricot seeds. Vale defied the injunction, however, and in 2004 was sentenced to 63 months in prison to be followed by 3 years of supervised release.
Part Six Protection of the Consumer514
health fraud. Table 25-1 illustrates several types of en- forcement actions. The FDA’s quackery-related warning letters are archived on the Casewatch Web site (www. casewatch.org). The FDA concentrates its efforts against health fraud on products that are inherently unsafe or are illegally marketed for the treatment of disease. Worthless yet harmless articles promoted to improve health, athletic ability, or appearance—which the agency considers mere “economic frauds”—are considered low priority and are virtually unregulated. Critics of this policy believe that routine use of criminal prosecution would enable
the FDA to deter the marketing of bogus products. As Barrett23 has noted: The Internal Revenue Service has made it clear that cheating on income tax can cost people dearly and land them in jail. The FDA should make it clear that cheating on product labels (as well as accompanying literature) can cost just as dearly.
Educational Activities The FDA distributes many publications about foods, drugs, devices, cosmetics, and hazardous substances. Also, public affairs officers are available to answer questions and to participate in educational programs at
exampLes oF Fda reguLatory aCtions
Table 25-1
Seller Enzymatic Therapy
Green Bay, Wisconsin
Evenbetternow, LLC, Oro Valley, Arizona, and seven other companies
James Folsom San Diego
Naturally Good Marietta, Georgia (health-food store)
Potentials Unlimited Grand Rapids, Michigan
Standard Homeopath- ic Company, Los Angeles
Weil Lifestyle LLC drweil.com (official Web site of Andrew Weil, M.D.)
Products/Claims Raw Thyroid Complex and 55 other prod-
ucts marketed with unsubstantiated claims that they can “support” many organs and bodily functions.
Eight companies sold oral chelation products that were unapproved drugs. Four also of- fered unapproved urine test kits for heavy metals.
Rife “biofrequency” devices that were claimed to emit electrical forces that could cure many serious diseases.
Gamma-hydroxybutyrate (GHB), a danger- ous product promoted for strength training, muscle-building, weight loss, and sleep induction; also known as the “date-rape” drug
.
“Hypnotic sleep tapes” on 31 subjects, mar- keted with false and misleading claims for acne, allergies, bedwetting, facial tic, high blood pressure, tooth and gum problems, and many other ailments.
Hyland’s Homeopathic Teething Tablets found to contain enough belladonna alka- loid to cause serious symptoms.
Site claimed that Immune Support Formula was “used traditionally to ward off colds and flu” and to “support normal, healthy defenses against the common stressors that can hamper optimal day-to-day functioning.”
Action/Disposition A consent decree and permanent injunc-
tion prohibits the company from mak- ing unsubstantiated health claims for these or similar products.
FDA issued a public advisory and sent warning letters to the companies. Most responded by withdrawing the products.
Folsom was convicted of selling unap- proved medical devices and was sen- tenced to 30 months in prison.
Following a criminal search and seizure, owner Joseph Saffar pleaded guilty to introducing a misbranded drug in inter- state commerce. He was sentenced to 21 months in prison and fined $30,000.
Court ruled that the tapes were “devices” under the law because they were marketed with (illegal) therapeutic claims. The court ordered the tapes constructively destroyed by erasing their contents.
FDA public advisory was accompanied by a voluntary recall.
In response to an FDA warning letter, the challenged claims were withdrawn.
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 515
schools and elsewhere throughout their districts. “Talk Papers” and “Backgrounders” are available on many subjects. Most of this information is accessible on the agency’s Web site at www.fda.gov. Details of specific enforcement actions may be obtainable by filing a Free- dom of Information Act request, but fulfillment of these requests typically takes 1–3 years. During the mid-1980s the FDA gave high priority to public education about health fraud, which the agency defined as “the promotion, for profit, of a medical remedy known to be false or unproven.” The agency’s current educational outreach is mainly through its Web site.
FederaL trade Commission
The FTC is an independent federal agency directed by five commissioners nominated by the president and confirmed by the Senate, each serving a 7-year term. The president chooses one commissioner to act as chairman. The FTC’s law enforcement work is divided among its bureaus of Consumer Protection, Competition, and Economics. The Bureau of Consumer Protection aims to keep the marketplace free from unfair, decep- tive, or fraudulent practices. Its five divisions are credit practices, marketing practices, advertising practices, service industry practices, and enforcement. The Bureau of Competition is the FTC’s antitrust arm and seeks to prevent business practices that restrain competition. The
Bureau of Economics provides economic analysis and support to the FTC’s consumer protection activities. The FTC’s activities are reported on its Web site (www.ftc.gov), which contains news releases, consent agreements, policy statements, consumer advisories, and many other important documents.
FTC Laws The Federal Trade Commission Act (1914) provides safeguards against business monopoly and makes unfair practices unlawful, thereby protecting consumers as well as other entrepreneurs. The Wheeler-Lea Amendment (1938) enables the FTC to regulate advertising. It states:
It shall be unlawful for any person, partnership, or corporation to disseminate, or cause to be disseminated, any false adver- tisements—by the United States mails, or in commerce by any means, for the purpose of inducing . . . the purchase of food, drugs, devices, or cosmetics. . . . The dissemination . . . of any false advertisement . . . shall be an unfair or deceptive act or practice in commerce.
The Fair Packaging and Labeling Act (1966) bans unfair and deceptive packaging and labeling of consumer commodities. It gives the FTC responsibility in all areas except food, drugs, devices, and cosmetics, which are the purview of the FDA. The Magnuson-Moss Act (1975) enables the FTC to adopt trade regulation rules that define unfair or de- ceptive acts in a particular industry and make it much simpler to stop them.
Enforcement Actions When the commission feels that a company is making a false or deceptive advertising claim, it may seek to stop the advertisement or require some other appropriate remedy.24 FTC actions can be triggered by letters from consumers, businesses, members of Congress, or other interested parties. However, the agency will not usually act unless the matter involves interstate commerce and is believed to involve a significant problem such as a safety hazard or substantial economic harm to the public. The first step is an investigation. If the FTC con- cludes that the law has been violated, it may attempt to obtain voluntary compliance by entering into a consent order with the violator. Signers of a consent order need not admit that they have violated the law, but they must agree to stop the practices described in an accompanying complaint. If a consent agreement cannot be reached, the FTC may issue an administrative complaint that leads to an adjudication by an FTC administrative law judge. If a
√ Consumer Tip
Consumer Protection Insight The key points of product-related consumer-protec- tion law are: (a) disclosure of ingredients; (b) com- plete instructions for use, including warnings about potential adverse effects; (c) premarketing proof of safety; (d) a duty to track products to discover any unanticipated adverse effects; (e) premarket proof that a product is effective for its intended purpose; and (f) truthfulness in advertising. Although some people clamor for “health free- dom” (the ability to market whatever they please without government regulation), they cannot demon- strate how any of the above requirements can be set aside without hampering the ability of consumers to make informed decisions. Even though these basic principles are straightforward, it took a great deal of sad experience and political struggle to enact them into law.
Part Six Protection of the Consumer516
problem is considered serious enough, the FTC can seek a federal court order (injunction) to stop the improper practices. In egregious fraud cases, it can ask the Justice Department to file a criminal action. When the administrative complaint is disputed, an administrative law judge holds a formal hearing similar to a court trial. Evidence is submitted, testimony is heard, and witnesses are examined and cross-examined. If the judge finds the law has been violated, a cease and desist order or other appropriate relief can be issued. Initial decisions by administrative law judges can be appealed to the full commission, which acts like a court of appeal. Respondents who are dissatisfied with the commission’s decision can appeal their case to the U.S. Court of Ap- peals and ultimately to the U.S. Supreme Court. The FTC staff may not appeal the commission’s decision. If a consent agreement is reached or the FTC’s com- plaint is upheld on appeal, a financial penalty may be assessed that can include making restitution available to consumers or donating money for research. Occasionally a company must do “corrective advertising,” in which future ads must indicate that previous ads had been false, inaccurate, or misleading. Future violations of consent agreements or cease and desist orders can result in fines of up to $16,000 per day for each violation. Companies going through the administrative or court procedures just described can usually continue the disputed practice(s) if they choose to do so. When the FTC believes that an unfair practice will cause great public harm if allowed to continue, it may ask a federal court to issue an injunction. If a permanent injunction is issued, it may include financial penalties and consumer redress. When the FTC believes that a problem affects an entire industry, it can promulgate an industry guide or trade regulation rule. Guides are interpretive statements without the force of law. Rules represent the conclusions of the commission about what it considers unlawful. Before guides and rules are established, interested par- ties are given the opportunity to comment. Once a rule is established, the commission can take enforcement action without lengthy explanations about why a particular ad is unfair or deceptive. A reference to the rule is enough. In health matters, problems are almost always handled on a case-by-case basis rather than through rule-making. Although FTC actions are powerful, the agency’s ability to protect consumers is limited by two factors. The agency does not have sufficient resources to investigate most of the complaints it receives. Its regulatory actions can take years to complete, particularly when contested. Months or even years may go by before an investigation begins or is completed. Unless a consent agreement or
injunction is obtained, further delays can occur with each step in the process. This enables some operators to make considerable profits before their improprieties are stopped. During the 1980s the FTC completed prosecution of about five cases per year involving health-related claims. During the past 20 years the average has been about 30 per year. In recent years, the most significant FTC targets have been Kevin Trudeau and Donald W. Barrett, both of whom marketed infomercials that the agency considered deceptive. In 1998, in connection with six infomercials that he developed, Trudeau signed a consent agreement to (a) pay $500,000 in consumer redress, (b) be barred from making false claims for products in the future, and (c) establish a $500,000 escrow account or performance bond to ensure compliance. In 2004, after having been charged with false advertising of coral calcium and a bogus pain-relief product, Trudeau signed a consent agreement under which he agreed to pay a $2 million penalty and be banned from appearing in, producing, or disseminating future infomercials that advertise any type of product, service, or program to the public, except for “truthful infomercials for books, newsletters, and other informational publications.” An FTC official stated that the ban was “meant to shut down an infomercial empire that has misled American consumers for years.”25
Despite this, in 2006, Trudeau began using infomercials to market a book he wrote called The Weight-Loss Cure “They” Don’t Want You to Know About. The supposed “cure” was centered around the use of injections of human chorionic gonadotropin (HCG). However, scientific studies demonstrated that HCG injections didn’t cause weight loss and regulatory actions by the FTC and FDA have curbed their use in the United States. In 2007, the FTC charged Trudeau with violating the previous consent agreement by misrepresenting the contents of the book and asked the Illinois Federal Court to hold him in contempt. The court did so, banned him for three years from involvement in infomercials for publications in which he has a financial interest, and subsequently ordered him to disgorge $37,616,161, which the judge said was a reasonable approximation of the loss consumers suffered as a result of Trudeau’s deceptive infomercials.26
In 2008, a federal district court concluded that Barrett, his associate Robert Maihos, and two compa- nies they control (Direct Marketing Concepts, Inc., and ITV Direct, Inc.) had deceptively claimed that Supreme Greens and Coral Calcium were effective against can- cer and other serious diseases and that Coral Calcium would be absorbed better and faster than other calcium
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 517
products. The court froze the defendants’ assets, ordered them to pay $48.2 million for consumer refunds, and barred them from making deceptive claims or unauthor- ized credit or debit card charges in the future.27
Internet Activities The FTC has a very aggressive program aimed at frauds promoted through the Internet. Since 1996, it has con- ducted nine “Surf Days” aimed at providing information to entrepreneurs who may be violating the law. For the first, staff attorneys and investigators were joined by scores of others from federal, state, and local agencies. Over a 3-hour period, this ad hoc task force located more than 500 Web sites or newsgroup messages promoting apparent pyramid schemes. The FTC staff e-mailed a warning message to the individuals or companies that had posted these solicitations, explaining that pyramid schemes violate federal and state law and providing a link back to the FTC Web site for more information. A month later, the investigative staff checked and found that a substantial number had disappeared or been im- proved. In 1997, the FTC conducted North American Health Claim Surf Day with help from other federal agencies; 18 state attorneys general; and many nonprofit health organizations and consumer protection and information agencies from the United States, Canada, and Mexico. The participants surfed the Internet for questionable claims related to preventing or treating heart disease, cancer, AIDS, diabetes, arthritis, and multiple sclerosis, and sent hundreds of e-mail warnings that claims re- quire adequate substantiation. In 1998, the process was repeated by an international coalition of 80 government and private agencies and organizations from 25 countries whose participants issued more than 1200 warnings. From 2001 through 2008, the coordinated activity was referred to as Operation CureAll and included consumer education through an FTC Web page. Another FTC Internet activity has been the posting of “teaser sites” that mimic pyramid schemes, scholarship scams, false weight-loss claims, and fraudulent vending opportunities—typical frauds that have been practiced on consumers through direct mail, telemarketing, and other means. The teaser sites are registered with major search engines so that they may be encountered by consumers about to become ensnared by plausible but untrue come- ons. Instead of being swindled, the visitors are warned about the deceptive nature of the scams. In 2005, the FTC28 launched a multimedia campaign to help consumers stay safe online. The campaign’s Web site www.onguardonline.gov contains tips, articles, videos, and interactive activities that address how to rec-
ognize scams; shop securely; avoid hackers and viruses; and deal with spam, spyware, and phishing (a way of attempting to acquire information such as usernames, passwords, and credit card details by masquerading as a trustworthy entity in an electronic communication).The top 10 spams include weight loss claims and cure-all products.
u.s. postaL serviCe
The Postal Service has jurisdiction when payment is sent through the mail for products or services. During the 1970s and 1980s, it had an active program in which in- spectors monitored publications and took action against advertisers of bogus mail-order health products. How- ever, it has not initiated any cases against such products since the early 1990s.
other FederaL agenCies
The Consumer Information Center stocks and distrib- utes many consumer publications, some available free and some for a modest fee. Its catalog includes many publications on health and nutrition topics. The Centers for Medicare & Medicaid Services (CMS) administers Medicare and Medicaid programs, maintains statistics on health-care costs, and oversees federal quality control programs related to health care. Its journal, Health Care Financing Review, which reported on the economics of health care, was published quarterly from 1979 to 2009 and can be accessed online. In 2010, this was replaced by Medicare & Medicaid Research Review, which is published only online. The Consumer Product Safety Commission (CPSC) distributes information, receives complaints about the safety of products, and can set voluntary guidelines. The Environmental Protection Agency, among its many duties, sets standards for water quality and pesti- cide tolerances for foods (which the FDA enforces). The Federal Bureau of Investigation (FBI) has more than 100 special agents investigating health fraud. Most are cases in which Medicare or private insurance com- panies have been defrauded. The Government Accountability Office (GAO), formerly called the General Accounting Office, gath- ers information to help Congress determine how well executive branch agencies are doing their jobs. Some of its reports involve consumer health issues. The National Institutes of Health (NIH) is the federal government’s primary agency for supporting and con- ducting biomedical research and training. Its 306-acre campus in Bethesda, Maryland, houses 27 institutes and
Part Six Protection of the Consumer518
centers and a 500-bed hospital. NIH also holds confer- ences and distributes publications on health matters. The NIH Center for Alternative and Complementary Medicine, which has not been a trustworthy source of information, is discussed in Chapter 8. The National Health Information Center (NHIC) was established in 1979 as a service of the Office of Disease Prevention and Health Promotion of the U.S. Public Health Service. NHIC operates a toll-free hotline through which it refers callers to more than 1400 organizations that can provide health-related information. It also issues reports about information resources. Although NHIC’s leads usually are reliable, it refers people who inquire about nonscientific methods to organizations that es- pouse them. The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services was created in 1976 to help detect and prevent waste, fraud, and abuse. OIG conducts many audits, investigations, and inspections; issues reports; and maintains a hotline for reporting frauds involving Medicare and other gov- ernment programs. Its activities are summarized each January and July in its Semiannnual Report. The most common frauds it investigates involve false claims filed under the Medicare and Medicaid programs. The U.S. Centers for Disease Control and Prevention (CDC) studies public health problems and administers national programs for disease prevention. Its many activities include tracing the source of epidemics, moni- toring reportable diseases, preparing to deal with health threats, and publishing the Morbidity and Mortality Weekly Report (MMWR). The U.S. Department of Agriculture (USDA) sup- ports and conducts nutrition research and enforces stan- dards for meat and poultry products. It also publishes periodicals and other reports on nutrition research, food safety, and the food marketplace.
state and LoCaL agenCies
State and local agencies that offer information or other help to consumers include health departments, profes- sional licensing boards, consumer protection bureaus, attorneys general, and agriculture departments. Hun- dreds of counties and cities have offices that deal with consumer affairs, including health matters. Consumers should investigate the resources in their area if they have problems involving health products or services. During recent years the FDA, the FTC and state agencies have taken many joint enforcement actions. At a 1996 National Association of Attorneys General conference, FTC Chairman Robert Pitofsky noted that
all of the agencies were awash in a “sea of fraud.” That description is still valid today..
physiCian reguLation
The agencies involved in the surveillance and disciplin- ing of physicians include medical societies, hospitals, managed-care organizations, state licensing boards, and agencies that administer or oversee government-funded insurance programs. Medical societies, which doctors join voluntarily for social, educational, and/or political reasons, have the ability to reprimand or expel members. Such actions may be embarrassing or lower a physician in the eyes of colleagues, but they do not curtail the right to practice medicine. Hospital officials have the ability to reduce, suspend, or revoke a physician’s treatment privileges at their par- ticular hospital. This could be devastating to a surgeon in a one-hospital community. But practitioners who work primarily in private offices or who have privileges at another hospital are affected less. Physicians who belong to neither a medical society nor a hospital staff are unaf- fected by the disciplinary efforts of these organizations. The agencies that administer Medicare and Medicaid have the ability to terminate a practitioner’s participation in these programs in cases of fraud or overutilization. A managed-care organization can terminate participa- tion of a provider who fails to meet the organization’s standards. Such actions have considerable impact on physicians accustomed to seeing many patients under these programs. State licensing boards have the authority to revoke or suspend a practitioner’s license. This is a powerful action, but several factors hamper the effectiveness of state boards. A state board cannot take action unless it receives a complaint, and patients and professional col- leagues often are afraid that making a complaint might involve them in an unpleasant confrontation or even a lawsuit. Equally important, many state boards have insufficient staff and funds to do their job properly. Moreover, because the physician’s livelihood is at stake, the courts are inclined to offer considerable protection. The situation noted long ago by Derbyshire29 is still true today:
The best efforts [of the boards] are often hampered by the capriciousness of the courts, which do not hesitate to substi- tute their judgment for that of the boards. They often issue stay orders in cases in which the boards have revoked the licenses of physicians. Furthermore, these stay orders permit the defendant to continue his [predatory behavior] during the long delays before his appeal is finally heard.
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 519
In response to public and medical society pressure, licensing laws have been tightened in many states. Although court interference and underfunding remain problems, actions against physicians by state licens- ing boards have increased over the past 30 years. The Federation of State Medical Boards30 states that the number of serious disciplinary actions against medical and osteopathic physicians has risen from 2804 in 1991 to 5652 in 2010. The 2010 figure includes 4798 serious actions (license losses, suspensions, restrictions, or other prejudicial actions). State boards also take informal ac- tions that significantly affect the behavior of the doctors involved. Some physicians not included in these totals were subjected to federal actions that excluded them from Medicare participation or revoked or restricted their narcotic license. Most of the medical board Web sites indicate when disciplinary actions have been taken, and many post the relevant documents. The Public Citizen’s Health Research Group (HRG)31 has noted that the rates of serious disciplinary actions vary greatly enough from state to state to con- clude that many state boards do not function adequately. HRG believes that boards are likely to be able to do better if most, if not all, of the following conditions are met: (a) adequate funding; (b) adequate staffing; (c) strong leadership; (d) investigate proactively rather than depending on complaints; (e) use data from sources such as Medicare and Medicaid sanctions, hospital sanctions, and malpractice payouts; (f) independence from medical societies and other parts of state government; and (g) laws that permit decisions based on a preponderance of evidence rather than “beyond reasonable doubt” or “clear and convincing evidence” standards. The federal Office of the Inspector General (OIG) administers two agencies that collect adverse informa- tion about physicians and other health-care providers. However, the information is not available to the general public. The Data Bank, consisting of the National Practi- tioner Data Bank (NPDB) and the Healthcare Integrity and Protection Data Bank (HIPDB), is a confidential information clearinghouse created by Congress to im- prove health-care quality, protect the public, and reduce health-care fraud and abuse in the U.S.32
The NPDB, which began operating in 1990, was mandated by the Health Care Quality Improvement Act of 1986. Its purpose is to hinder the movement of “prob- lem practitioners” from one facility or state to another. Licensing boards are required to report all actions that revoke, suspend, or restrict a license for reasons related to the practitioner’s professional competence or conduct.
Professional societies must report all professional re- view actions that adversely affect the membership of a physician or dentist. Hospital administrators must report disciplinary actions that negatively affect a doctor’s clini- cal privileges for more than 30 days and must query the Data Bank when appointing or reappointing medical and dental staff. Malpractice insurance carriers are required to report all settlements against physicians, dentists, and other licensed health-care providers. The informa- tion is available to state licensing boards; hospitals and other health-care entities; professional societies; certain federal agencies; and plaintiffs (or their attorneys) in a malpractice suit. The HIPDB, which became operational in 1999, was mandated by the Health Insurance Portability and Ac- countability Act of 1996. Its purpose is to combat fraud and abuse in health insurance and health-care delivery. It collects information about licensure and certification actions, criminal convictions, exclusions from federal and state health-care programs, civil judgments (other than malpractice actions) related to health care, and other adjudicated actions or decisions. The information can be accessed by health plans and federal and state agencies. After analyzing data in the NPDB Public Use File for 1990–2009, HRG33 reported that 2071 (19.4%) of the 10,672 physicians who had clinical privileges revoked or restricted by a hospital for incompetence, negligence, substandard care, fraud, sexual misconduct or other seri- ous reasons had escaped medical board action.
nongovernmentaL organizations
Hundreds of organizations play a role in helping to educate and protect consumers in health matters. These organizations can be broadly classified as voluntary, business, or professional. Their activities include re- search, publications, advice to consumers, media con- tacts, testimony to government agencies, lawsuits, and promotion of legislation. Voluntary Organizations Voluntary organizations generally are nonprofit corpora- tions formed to assist the public in various ways. Some are supported primarily by dues from their members, some primarily by contributions, and some by both. Consumer groups may address a broad range of con- sumer issues or focus on limited areas, such as health or health fraud. Many voluntary organizations support research and provide consumer education about a spe- cific disease or diseases. The American Cancer Society and the American Heart Association are two of the most
Part Six Protection of the Consumer520
prominent groups of this type. Other organizations, designated “self-help groups,” provide information and emotional support for individuals and families affected by particular diseases. Some voluntary organizations that have had signifi- cant impact on the consumer movement in the United States are described below. Consumers Union (CU), founded in 1936, evaluates products and produces Consumer Reports magazine and Consumer Reports on Health (its monthly news- letter). CU’s Washington office monitors government activities and represents consumers through lawsuits and testimony before regulatory agencies. Web sites for the magazine and newsletter are accessible by subscription. CU also maintains a site (www.bestbuydrugs.org), which is accessible free of charge. The Public Citizen Health Research Group (HRG), founded in 1971 by Ralph Nader and Sidney Wolfe, M.D., is directed by Dr. Wolfe and staffed by health professionals, attorneys, and researchers. They publish a monthly newsletter; monitor government health agen- cies; analyze proposed legislation; and take vigorous action—including lawsuits—when they believe that the government is lax in protecting consumers from dangerous foods, drugs, or medical practices. In 1987, for example, HRG forced the FDA to ban interstate sale of unpasteurized milk. HRG also investigates and issues reports on economic and quality-of-care issues. The reports have covered medical fees, hospital evaluation, unnecessary surgery, mental health care, vision care, medical discipline, and many other topics. The Center for Science in the Public Interest (CSPI) was founded in 1971 by former associates of Ralph Nader and reportedly has several million members. It publishes the monthly Nutrition Action Healthletter, as well as booklets, posters, computer software, and other materials, most of which concern foods and food choices. It also engages in lawsuits and political activities intended to foster what it believes are better policies to- ward health and environmental issues by government and industry. CSPI has filed many lawsuits and stimulated many significant government actions to protect consum- ers. But it also promotes “organic” foods, suggests that everyone should take dietary supplements, and projects an alarmist attitude toward the American diet and food supply. AARP, founded in 1958, provides its 33 million members with guidance on a wide variety of economic and health issues. It publishes AARP The Magazine as well as many pamphlets and books. AARP’s advice about hearing aids, nursing homes, drugs, and many aspects of
medical care has been trustworthy, but the quality of its advice about dietary supplements has been inconsistent. Quackwatch, headed by Dr. Stephen Barrett, is an informal international network of people who are concerned about health-related frauds, myths, fads, fallacies, and misconduct. Its activities include (a) in- vestigating questionable health claims, (b) distributing reliable publications, (c) reporting illegal marketing, (d) generating consumer-protection lawsuits, (e) attacking misleading advertising, and (f) improving the quality of health information on the Internet. Quackwatch.org and its subsidiary sites contain more than 5000 pages of information related to quackery, health frauds, and other consumer health topics. Their primary focus is on quackery-related information that is difficult or impossible to get elsewhere. Dr. Barrett also sponsors the Health Fraud Discussion List (an e-mail newsgroup open to the public) and, with help from Dr. William M. London, edits Consumer Health Digest (a free weekly e-mail newsletter). Casewatch (www.casewatch.org) contains more than 2000 archived documents related to regulatory activities. The Committee for Skeptical Inquiry (CSI), formerly called the Committee for Scientific Investigation of Claims of the Paranormal (CSICOP), was founded in 1976 to encourage critical investigation of paranormal and fringe-science claims. It is composed of prominent scientists, educators, and journalists and is assisted by more than 50 scientific and technical consultants. It publishes a monthly report (Skeptical Briefs) and a bimonthly journal (Skeptical Inquirer). Groups similar to CSI exist in many areas of the United States and in several foreign countries. The Skeptics Society was founded in 1992 to pro- mote science and critical thinking and to disseminate information on pseudoscience, pseudohistory, and fringe claims and groups. It sponsors lectures and telecasts, publishes a quarterly magazine (Skeptic), and distributes other educational materials. The Institute for Science in Medicine (ISM), founded in 2009, is an international policy institute that seeks to promote science as the best and only way to ensure that health care is safe, high quality, and cost-effective. ISM is particularly concerned about the growing num- ber of fringe practitioners and their medically dubious diagnoses and treatments. Several of its leaders produce the Science-Based Medicine Blog (www.sciencebased- medicine.org), which comments daily on irrational health practices and policies. The American Council on Science and Health (ACSH) was founded in 1978 to evaluate issues involv-
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 521
ing food, drugs, chemicals, the environment, lifestyle, and health. ACSH has more than 300 prominent scientific and policy advisers. It produces peer-reviewed reports and a free e-mail newsletter. It also hosts seminars and press conferences, maintains several Web sites, serves as a clearinghouse for the news media, and answers individual inquiries from the public. Citizens for Responsible Care and Research (CIRCARE) works to protect human research subjects. Its Web site (www.circare.org) includes many documents related to regulatory and disciplinary actions. Other groups that attack quackery include the James Randi Educational Foundation and Sense about Science. The Anti-Quackery Ring provides a convenient gateway to about 70 antiquackery Web sites. Its URL is http://hub.webring.org/hub/antiquackerysite.
Business Organizations Many business organizations provide information and educational materials to consumers. America’s Health Insurance Plans (AHIP), for example, provides trustwor- thy information about the insurance coverage, and the National Dairy Council provides reliable information about food and nutrition. ConsumerLab.com (CL) is the leading provider of independent test results and information about dietary supplements, herbal products, and the like. Its test re- sults are published at www.consumerlab.com. CL also enables companies to have products voluntarily tested; those that pass the test are permitted to bear the CL seal on their label. CL’s www.pharmacychecker.com Web site reports on the reliability and prices of foreign mail-order pharmacies. The Council of Better Business Bureaus is unique among business groups because it also takes an advocacy role in encouraging truth in advertising and other good business practices through industrial self-regulation. It has published a code for advertising and selling as well as pamphlets to help consumers make wise purchasing decisions. The council maintains a searchable online database of reports on individual companies. The Council’s National Advertising Division (NAD) receives and adjudicates complaints about nationally circulated advertising and causes some manufacturers to withdraw health-related ads that are challenged. Lo- cal Better Business Bureau offices can sometimes help consumers with complaints about health products and services provided by local businesses; however, prob- lems with licensed practitioners usually are referred to medical societies or state licensing boards. The Electronic Retailing Association (ERA), the trade association for major companies who use electronic media to advertise goods and services to the public, evaluates complaints about infomercials and refers violators to the FTC.
Professional Organizations Health professionals can join a multitude of local, state, and national groups interested in promoting their profession or specialty. Many such groups provide high- quality information to the general public. The largest is the American Medical Association, which evaluates information, publishes books and journals, conducts seminars, engages in lawsuits and legislative activity, of- fers information to the public and the media, and engages in many other activities. The publications of recognized professional groups are generally reliable and well writ- ten; many such groups are listed in the Appendix.
Personal Glimpse
“Cancer Cure” Infomercial Blasted In 2004, the National Advertising Division (NAD) of the Council of Better Business Bureaus concluded that claims made in an infomercial promoting Dr. Lorraine Day’s videotapes were unsubstantiated. Day, a nonprac- ticing orthopedic surgeon, claims to have cured herself of metastatic breast cancer with a 10-step program featuring diet and prayer. For several years, she has marketed videotapes that provide her story and advise consumers to use her program rather than standard treatment. Although she has released medical records showing that she had a biopsy followed by a wider local operation, she has refused to release additional records that might show whether or not any cancer remained after the second operation, which Dr. Stephen Barrett believes to have cured her.33 After Barrett complained, NAD investigated and recommended that the infomer- cial producer (ITV Direct) stop asserting that:
• Day still had cancerous cells after her second opera- tion and that doctors “sent her home to die.”
• If people go on a vegetarian diet, exercise on a regu- lar basis, and decrease their alcohol intake, they will decrease their incidence of cancer by 33%.
• Chemotherapy doesn’t work for anybody.
ITV Direct, which was facing FTC action in con- nection with two other infomercials, disagreed with NAD’s conclusions but said it would “take them under advisement for all future edits or modifications of the infomercial.” NAD indicated that if the infomercial were not modified within a reasonable period of time, it would complain to the FTC.
Part Six Protection of the Consumer522
Consumer aCtion
For society to improve, people must speak out loudly and clearly when they have been misled. Individual consumers as well as agencies and organizations must assume responsibility in this regard. Individuals often feel helpless when cheated, but they must fight back by registering complaints. The system will not change unless people want it to be modified and are willing to take action on their own behalf. If you encounter a food, drug, device, cosmetic, or other health-related product that appears to be misla- beled or otherwise defective, you can perform a public service by reporting it to the FDA. If you encounter false advertising, you can perform a similar service by reporting it to the FTC or to your state attorney general. When services rather than products are involved, a state or local agency is likely to be most helpful.
Table 25-2 summarizes where consumer complaints can be sent. Complaints to federal agencies may receive extra attention when a member of Congress is involved, so it is often a good idea to send a copy of your complaint to your congressional representatives. Where more than one enforcement agency appears to have jurisdiction, it is best to contact all of them. To make a complaint, record what you have observed and what you think is wrong, and send or deliver this information to the appropriate agency along with any evidence you have collected. If your complaint involves a food or drug, enclose the label or a complete descrip- tion of the label (including code marks) and indicate where you obtained the product. If your complaint involves a product you have used, check first to be sure you followed the directions. If you have what appears to be an adverse effect to a medication, the problem is most likely an allergy or a side effect known to the
where to CompLain or seeK heLp* Table 25-2
Problem False advertising
Product marketed with false or misleading claims
Bogus mail-order promotion
Dubious telemarketing (false claims or “do-not-call” violations)
Improper treatment by licensed practitioner
Improper treatment by unlicensed individual
Advice needed about questionable product or service
Medicare or Medicaid fraud
Junk e-mail, including health-related scams and chain letters
Inaccurate articles on a Web site
Agencies to Contact FTC Bureau of Consumer Protection or regional office National Advertising Division, Council of Better Business Bureaus Electronic Retailing Association (infomercials) Editor or manager of media outlet where ad appeared
National or regional FDA office State attorney general State health department Local Better Business Bureau Congressional representatives
State attorney general
State attorney general FTC National Do Not Call Registry (if you are registered)
Local or state professional society (if practitioner is a member) Local hospital (if practitioner is a staff member) State professional licensing board
Local district attorney State attorney general
Local, state, or national professional or voluntary health groups
FBI and HHS Office of the Inspector General hotlines
FTC’s e-mailbox ([email protected])
Health on the Net Foundation (if site displays HONcode seal)
*See www.chsourcebook.com for contact information. When more than one regulatory agency appears to have jurisdiction, contact each of them. © 2010, Stephen Barrett, M.D.
Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 523
FDA rather than poor quality of the medication. Your doctor can be consulted to find this out. If you complain about an advertisement, indicate when and where you observed it. Grievance procedures related to practitioners are discussed in Chapter 5. Information supplied by consumers often leads to detection and correction of a problem. Many people are afraid that making a complaint will subject them to legal action or involve them in a time-consuming process. This is unlikely, however. Complaints made in good faith are privileged—which means the complainant is shielded from liability. Nor is a complainant likely to be needed as a witness in a court proceeding. Regulatory agencies almost always conduct their own investigations and proceed on the evidence gathered by their trained investigators.
summary
Consumer protection in health matters has two com- ponents: education and law enforcement. Intelligent consumers accept personal and public responsibility for the protection of health. They actively pursue the information needed to make wise decisions about health products and services. They are willing to speak out and encourage social and governmental action against mis- representations and fraudulent practices. Government agencies, in turn, must establish and enforce standards for professional competence and honest marketing of products and services.
reFerenCes
1. Barrett S, Herbert V. The Vitamin Pushers: How the “Health Food” Industry Is Selling America a Bill of Goods. Amherst, N.Y., 1994, Prometheus Books.
2. Magnuson W, Carper J. The Dark Side of the Marketplace: The Plight of the American Consumer. Englewood Cliffs, N.J., 1968, Prentice-Hall.
3. Young FE. FDA. The cop on the consumer beat. FDA Consumer 22(3):6–7, 1988.
4. Strategic Priorities 2011–2115: Responding to the Public Health Challenges of the 21st Century. Washington, D.C., Sept 29, 2010, FDA.
5. Young JH. The Toadstool Millionaires: A Social History of Patent Medicines Before Federal Regulation. Princeton, N.J., 1961, Princeton University Press.
6. Reed LW. On Upton Sinclair’s The Jungle: How a food safety myth became a legend. Consumers’ Research 78(8):23–25, 35, 1995.
7. Young JH. The Medical Messiahs. Princeton, N.J., 1992, Princ- eton University Press.
8. Delusions of vigor: Better health by mail. Consumer Reports 44:50–54, 1979.
9. Developing products for rare diseases & conditions. FDA Web site, Jan 18, 2011.
10. Barrett S. How the Dietary Supplement Health Education Act of 1994 weakened the FDA. Quackwatch Web site, Feb 2, 2007.
11. Food and Drug Administration. Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body; final rule. Federal Register 65:999–1050, 2000.
12. Federal Food, Drug, and Cosmetic Act. FDA Web site, revised March 15, 2010.
13. Questions and answers: Caffeinated alcoholic beverages. FDA Web site, Nov 17, 2010.
14. Smith JS, Pillai S. Scientific status summary: Irradiation and food safety. Food Technology 58:48–55, 2004.
15. Use of Bovine Somatotropin (BST) in the United States: Its Potential Effects. Washington, D.C., 1994, Executive Branch of the U.S. Government.
16. Safety of Genetically Engineered Foods: Approaches to As- sessing Unintended Health Effects. Washington, D.C., 2004, National Academy Press.
The Intelligent Health Consumer • Identifies and uses trustworthy sources of informa-
tion. Chapters 2 and the Appendix list sources that the authors of this textbook recommend.
• Is skeptical and investigates the accuracy of health advertising before making purchasing decisions.
• Maintains a healthy lifestyle. • Understands which types of health problems can be
self-treated and which should receive professional care.
• Takes an active role in dealing with health profes- sionals, is assertive but tactful, endeavors to learn the nature of any ailment and the mechanism and potential hazards of treatment, and is aware of fees involved.
• Locates and uses a primary physician (or medical group) who provides scientific, considerate, and compassionate care.
• Uses medication properly; carefully reads labels and follows directions for safe use, is aware of common side effects, and requests generic drugs when appropriate.
• Is aware of the signs of quackery and health fraud; avoids unsubstantiated products and procedures and any practitioners who recommend them.
• Is familiar with the laws, regulations, and rights that protect consumers.
• Supports, participates in, and seeks help when needed from appropriate consumer organizations.
• Writes letters, makes phone calls, and takes other appropriate action to protest deceptive or fraudu- lent health practices.
√ Consumer Tip
Part Six Protection of the Consumer524
17. FDA Center for Drug Evaluation and Research. From Test Tube to Patient: Improving Health through Human Drugs. Rockville, Md., 1999, Department of Health and Human Services.
18. Basara LR, Montagne M. Searching for Magic Bullets: Orphan Drugs, Consumer Activism, and Pharmaceutical Development. Binghamton, N.Y., 1994, Haworth Press.
19. Clear thinking about regulating medicines: Tidal wave of unfounded attacks on Food and Drug Administration calls for a dispassionate look at agency’s record. Public Citizen Health Research Group Health Letter 11(3):1–5, 1995.
20. Young FE. Investigational new drug, antibiotic, and biological drug product regulations; treatment use and sale; final rule. Federal Register 52:19476–19477, 1987.
21. OTC ingredients. FDA Web site, April 7, 2010. 22. The Enforcement Story: Fiscal Year 2008. FDA Office of Regu-
latory Affairs, March 2009. 23. Barrett S. Quackery and the FDA: A complicated story. Nutrition
Forum 8:41–44, 1991. 24. Vladek D. About the Bureau of Consumer Protection. FTC Web
site, June 16, 2009. 25. Kevin Trudeau banned from infomercials. FTC news release,
Sept 7, 2004.
26. Getteleman R. Memorandum opinion and order. FTC v. Kevin Trudeau, No. 03 C 3904, filed April 16, 2010.
27. Appellate court upholds order requiring promoters of Su- preme Greens and Coral Calcium dietary supplements to pay $48.2 million for deceptive ads. FTC news release, Oct 29, 2010.
28. FTC and partners urge consumers to be on guard online. FTC news release, Sept 27, 2005.
29. Derbyshire RC. Medical Licensure and Discipline in the United States. Baltimore, 1969, The Johns Hopkins Univer- sity Press.
30. Summary of 2010 board actions. Federation of State Medical Boards Web site, accessed Nov 19, 2011.
31. Most states do not protect patients from substandard physicians, Public Citizen’s annual state medical board ranking finds. Public Citizen news release, May 12, 2011.
32. About us. Data Bank Web site, accessed Dec 1, 2010. 33. Levine A and others. State medical boards fail to discipline doc-
tors with hospital actions against them. Public Citizen, March 2011.
34. Barrett. S. Stay away from Dr. Lorraine Day. Quackwatch Web site, Feb 7, 2010.
TrusTworThy sources of
InformaTIon
Appendix
As you read this, health care consumers are undergoing a radical metamorphosis: They are becoming engaged, em- powered, energized e-Health consumers. They represent a vast force that is about to transform the health care world.
Deloitte Consulting, 1999
Science is not a democracy where people’s votes decide what is right. Look at the data, look at science, and make a decision based on science that has been published.
Paul offit, M.D.
©2000 WM HOEST ENTERPRISES, INC. ALL RIGHTS RESERVED
“Well, www.what’swrongwithme?.com says it’s just a virus, but I came to you for a second opinion.”
Appendix526
The organizations and agencies listed in this Appendix offer trustworthy health information. The Consumer Health Sourcebook (www.chsourcebook.com) links to their Web pages as well as to other sites that are useful for studying consumer health.
federal GovernmenT aGencIes
Administration for Children & Families Agency for Health Care Research and Quality (AHRQ) Center for Food Safety and Applied Nutrition (CFSAN) Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Consumer Product Safety Commission (CPSC) Department of Health and Human Services (DHHS) Environmental Protection Agency (EPA) Federal Consumer Information Center (FCIC) Federal Trade Commission (FTC) Food and Drug Administration (FDA) Government Accountability Office (GAO) National Cholesterol Education Program (NCEP) National Clearinghouse on Child Abuse and Neglect (NCCAN) National Health Information Center (NHIC) National Institutes of Health (NIH) National Cancer Institute (NCI) National Eye Institute (NEI) National Heart, Lung, and Blood Institute (NHLBI) National Human Genome Research Institute (NHGRI) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) National Institute of Child Health and Human Development
(NICHD) National Institute of Dental and Craniofacial Research
(NIDCR) National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) National Institute of Environmental Health Sciences (NIEHS) National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke
(NINDS) National Institute of Nursing Research (NINR) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute on Deafness and Other Communication
Disorders (NIDCD) National Institute on Drug Abuse (NIDA) National Library of Medicine (NLM) National Prevention Information Network (NPIN) National Maternal and Child Health Clearinghouse (NMCHC) National SIDS Resource Center (NSRC) Office of Dietary Supplements (ODS) Office of Disease Prevention and Health Promotion (ODPHP) Office of the Inspector General (OIG) Office of Postsecondary Education (OPE) President’s Council on Physical Fitness and Sports (PCPFS) Substance Abuse and Mental Health Services Administration
(SAMHSA) U.S. Department of Agriculture (USDA) U.S. Postal Service (USPS)
nonGovernmenTal orGanIzaTIons
Most of the organizations listed below are volun- tary groups that draw support and members from the general public as well as professionals. Some have a single national office, while others have chapters in various cities. Most of these organizations provide edu- cational materials on request. Some raise and distribute funds for research. Some conduct educational programs for the public and encourage and develop local support groups. Some offer individual counseling. Business and professional groups that are indicated by an asterisk (*) are composed exclusively or primarily of health professionals or other professionally trained individuals. Most of these groups publish a journal and hold educational meetings for their members. Most of them also help the public by issuing guidelines, set- ting professional standards, disseminating information through the Internet and other media, and/or responding to inquiries from individual consumers. Additional information on most of these organiza- tions can be obtained from the Encyclopedia of Medical Organizations and Agencies (Gale Research Company, Detroit), available in the reference department of many public libraries. Nonprofit groups are also described on GuideStar (www.guidestar.org), which hosts copies of their tax returns.
*Academy of Nutrition and Dietetics (formerly American Dietetic Association)
AcademyHealth Action on Smoking and Health (nonsmokers’ rights) Aerobics and Fitness Association of America Alexander Graham Bell Association for the Deaf Alzheimer’s Association *Ambulatory Surgery Center Association *America’s Health Insurance Plans (AHIP) *American Academy of Allergy, Asthma, and Immunology *American Academy of Child & Adolescent Psychiatry *American Academy of Family Physicians *American Academy of Ophthalmology *American Academy of Otolaryngology-Head and Neck Surgery *American Academy of Pediatric Dentistry *American Academy of Pediatrics American Academy of Physician Assistants *American Academy of Sleep Medicine American Alliance for Health, Physical Education, Recreation and
Dance *American Association for Health Education *American Association for the History of Medicine *American Association for Marriage and Family Therapy *American Association of Blood Banks *American Association of Diabetes Educators *American Association of Endodontists American Association of Kidney Patients *American Association of Pastoral Counselors *American Association of Plastic Surgeons
Trustworthy Sources of Information 527
*American Association of Sexuality Educators, Counselors and Therapists
*American Association of Suicidology American Association on Intellectual and Developmental
Disabilities (AAIDD) *American Board of Medical Specialties *American Burn Association American Cancer Society American Childhood Cancer Association *American College Health Association *American College of Cardiology *American Counseling Association *American Society of Clinical Oncology *American College of Gastroenterology *American College of Health Care Administrators *American College of Healthcare Executives *American College of Obstetricians and Gynecologists *American College of Physicians *American College of Radiology *American College of Rheumatology *American College of Sports Medicine *American College of Surgeons American Council on Science and Health *American Dental Association American Diabetes Association *American Epilepsy Society American Federation of HomeCare Providers American Foundation for AIDS Research American Foundation for the Blind *American Geriatrics Society American Group Psychotherapy Association *American Headache Society *American Health Care Association (nursing home standards) American Heart Association *American Hospital Association *American Industrial Hygiene Association American Kidney Fund American Liver Foundation American Lung Association *American Medical Association *American Medical Women’s Association American Mental Health Counselors Association *American Nurses Association *American Occupational Therapy Association *American Optometric Association American Pain Foundation *American Physical Therapy Association *American Podiatric Medical Association *American Psychiatric Association *American Psychoanalytic Association *American Psychological Association *American Public Health Association American Red Cross American Running Association *American School Health Association American SIDS Institute *American Sleep Disorders Association American Social Health Association (venereal disease) *American Society for Laser Medicine and Surgery *American Society for Nutrition *American Society for Reproductive Medicine *American Society for Surgery of the Hand *American Society of Clinical Hypnosis
*American Society of Clinical Oncology *American Society of Hematology *American Society of Law, Medicine, and Ethics *American Society of Plastic Surgeons *American Speech-Language-Hearing Association *American Thyroid Association American Tinnitus Association *American Urological Association *American Veterinary Medical Association Americans for Medical Progress (harm caused by “animal rights”
groups) Americans for Nonsmokers’ Rights Amyotrophic Lateral Sclerosis Association Anxiety Disorders Association of America Aplastic Anemia and MDS International Foundation The Arc of the United States (mental retardation) Arthritis Foundation (avoid information on “complementary” and
“alternative” methods) *Association for Ambulatory Behavioral Healthcare *Association for Behavioral and Cognitive Therapies Association for Macular Diseases Association for Science in Autism Treatment Asthma and Allergy Foundation of America Attention Deficit Disorder Association *Better Hearing Institute Bioethics Watch *BlueCross BlueShield Association Cancer Care Center for Studying Health System Change Center for the Study of Services Centre for Evidence-Based Medicine Childbirth Connection Children and Adults with Attention Deficit/Hyperactivity Disorder Children of Aging Parents Children’s Healthcare Is a Legal Duty (CHILD) Children’s Leukemia Research Association Citizens for Responsible Care and Research (CIRCARE) Cleft Palate Association Coalition Against Insurance Fraud Committee for Skeptical Inquiry (CSI) *Commonwealth Foundation Compassionate Friends Consumers Union Contraceptive Choices Cooley’s Anemia Foundation *Council for Agricultural Science and Technology (CAST) *Council of Better Business Bureaus Crohn’s and Colitis Foundation of America Cystic Fibrosis Foundation *Delta Dental Plans Association (dental insurance) Depression and Bipolar Support Alliance Drug Policy Alliance Dysautonomia Foundation Dystonia Medical Research Foundation Easter Seals National Headquarters *ECRI (medical devices, technology, and patient safety) Endometriosis Association EngenderHealth (women’s health issues) Epilepsy Foundation Euthanasia Research and Guidance Organization Eye Bank Association of America False Memory Syndrome Foundation *Federation of Societies for Experimental Biology
Appendix528
Federation of State Medical Boards *Food and Nutrition Board, National Academies Foundation Fighting Blindness Funeral Consumers Alliance *Gerontological Society of America Glaucoma Research Foundation Guttmacher Institute (family planning and women’s health issues) Health Policy Institute (Georgetown University) Huntington’s Disease Society of America Institute for Science in Medicine *Institute of Food Technologists Institute of Medicine (IOM) International AIDS Vaccine Initiative International Association for Medical Assistance to Travelers
(IAMAT) International Association of Laryngectomees International Center for Toxicology and Medicine International Cultic Studies Association (ICSA) International Dyslexia Association International Food Information Council Foundation *International Hearing Society *International Life Sciences Institute (nutrition, toxicology,
technology risk assessment) Interstitial Cystitis Association James Randi Educational Foundation (investigation of paranormal
claims) JED Foundation (mental health help for college students) *Joint Commission on Accreditation of Healthcare Organizations Joslin Diabetes Center Juvenile Diabetes Foundation Kaiser Family Foundation La Leche League International (breastfeeding) LeadingAge (formerly American Association of Homes and
Services for the Aging) Leukemia & Lymphoma Society Little People of America Living Bank (organ donor registry) Lupus Foundation of America March of Dimes Birth Defects Foundation Medic Alert Foundation International (emergency medical
information services) Mental Health America Muscular Dystrophy Association Museum of Questionable Medical Devices Myasthenia Gravis Foundation *NAADAC, the Association for Addiction Professionals National Academy Press National Alliance on Mental Illness *National Association for Chiropractic Medicine National Association for Continence *National Association for Home Care and Hospice National Association of Anorexia Nervosa and Associated Disorders National Association of Area Agencies on Aging National Association of Attorneys General National Association of the Deaf *National Association of Social Workers National Ataxia Foundation (loss of muscle coordination and
balance) National Breast Cancer Coalition National Center for Fluoridation National Center for Nutrition and Dietetics National Chronic Fatigue Syndrome and Fibromyalgia Association National Committee for Quality Assurance
National Consumers League National Council on Aging National Council on Patient Information and Education *National Dairy Council National Down Syndrome Congress National Family Caregivers Association National Family Planning and Reproductive Health Association National Federation of the Blind National Foundation for Infectious Diseases National Fraud Information Center *National Funeral Directors Association National Headache Foundation *National Health Council National Hemophilia Foundation *National Hospice and Palliative Care Organization National Kidney Foundation National Marfan Foundation National Multiple Sclerosis Society National Neurofibromatosis Foundation National Organization for Rare Disorders (NORD) National Organization on Disability National Osteoporosis Foundation *National Parkinson Foundation National Psoriasis Foundation National Safety Council National Scoliosis Foundation National Sleep Foundation National Spasmatic Torticollis Association National Spinal Cord Injury Association National Stroke Association National Tay-Sachs and Allied Diseases Association New England Skeptical Society Obsessive Compulsive Foundation Oncolink (cancer database) Oregon Fibromyalgia Foundation Osteogenesis Imperfecta Foundation Paget Foundation Parkinson’s Disease Foundation Physicians for a National Health Program (PNHP) Planned Parenthood Federation of America Prevent Blindness America Prevent Child Abuse America Public Citizen Health Research Group Resolve (infertility) Robert Wood Johnson Foundation Scleroderma Foundation Sexuality Information and Education Council of the United States
(SIECUS) Sickle Cell Disease Association of America Sjogren’s Syndrome Foundation Skeptics Society *Society for Clinical and Experimental Hypnosis *Society for Public Health Education Spina Bifida Association of America Tourette Syndrome Association *Trauma Center Association of America Tuberous Sclerosis Alliance United Cerebral Palsy United Network for Organ Sharing (UNOS) United Ostomy Associations of America *United States Pharmacopeial Convention, Inc. (drug
publications) U.S. Preventive Services Task Force
Glossary
Glossary530
accreditation: Approval by a recognized accrediting agency that a facility meets its standards. Hospitals and other health-care fa- cilities are accredited by the Joint Commission on Accreditation of Healthcare Organizations. Colleges and professional schools are accredited by agencies approved by the U.S. Secretary of Education or the Council on Recognition of Postsecondary Ac- creditation (CORPA). The Accreditation Council for Continuing Medical Education (ACCME) manages the accreditation system for continuing education for physicians.
acetaminophen: Nonprescription drug used to relieve pain and reduce fever; the active ingredient in Tylenol.
acidosis: State in which the blood is more acidic than normal. activities of daily living (ADLs): Term used to gauge how well
people can meet their basic physical needs. The five areas usu- ally considered are bathing, dressing, eating, toileting (includes whether or not the person is incontinent), and transferring (ability to get from place to place).
acupressure (shiatsu): Technique that uses surface stimulation by hand instead of needles at “acupuncture points.”
acupuncture: System of treatment purported to balance the body’s qi (“life force”) by inserting needles (or using other procedures) at points on alleged channels called “meridians.”
acute condition: Condition that has a rapid onset and follows a short but relatively severe course.
addiction: Persistent, habitual pattern of behavioral excess in which an activity (such as drug taking, eating, or gambling) becomes central to a person’s way of life despite its adverse consequences.
administrative complaint: Complaint alleging that a law has been broken, which can lead to a formal hearing before an administra- tive law judge.
administrative medicine: Occupation that encompasses the op- eration and management of organizations and institutions such as health departments, hospitals, clinics, and health-care plans.
adrenaline (epinephrine): Hormone, produced and stored by the adrenal glands, which can cause increased heartbeat and other reactions that prepare the body to meet emergency situations.
advance directive: Document in which a person states choices for medical treatment or designates who should make treatment choices if the person should lose decision-making capacity.
aerobic exercise: Exercise that requires oxygen to fully metabolize glucose. Aerobic exercise promotes cardiorespiratory fitness.
AIDS (acquired immunodeficiency syndrome): Disease, caused by the human immunodeficiency virus, in which the body’s im- mune system breaks down, leaving the body susceptible to certain infections and uncommon cancers.
alkalosis: State in which the blood pH is more alkaline than normal. allergen: Substance that produces an allergic reaction. allergic reaction: Excessive reaction of the body’s immune system
to a food, drug, or other substance that is ordinarily harmless. In susceptible individuals, exposure to an allergen can cause certain cells to release histamine, which can cause sneezing, wheezing, hives, and other reactions.
allopathy: Term coined by Samuel Hahnemann (founder of home- opathy) to designate medical practices based on the ancient Greek humoral theories that symptoms should be treated with opposites. (Many of his contemporaries, for example, used bloodletting to treat fevers that supposedly represented an excess of “blood hu- mor.”) Allopathy has been displaced by medical science, but the term is often used incorrectly to describe modern medical practice.
alopecia: Medical term for baldness. “alternative” health care: Misleading term used to characterize
many types of unscientific methods. Since ineffective methods
are not true alternatives to effective ones, the terms “unscientific” or “dubious” are more appropriate.
AMA: Abbreviation for American Medical Association. ambulatory health care: All types of health services provided to
patients who are not confined to an institutional bed during the time the services are rendered; also called outpatient care.
amino acid: Building block of proteins. anabolism: The phase of metabolism in which simple substances
are synthesized into the complex materials of living tissue (e.g., proteins from amino acids).
anaerobic exercise: Intense exercise, such as sprinting, that gener- ates energy by converting glucose to lactic acid, which does not require oxygen.
analgesia: Pain relief. analgesic, external: Drug applied to the skin to relieve pain. analgesic, internal: Pain reliever designed to be taken by mouth
or injected. anaphylactic shock: A sudden, life-threatening allergic reaction
characterized by a sharp drop in blood pressure, difficulty breath- ing, and hives.
androgenic steroid: A steroid hormone, such as testosterone or androsterone, that controls the development and maintenance of masculine characteristics.
anecdotal evidence: Brief accounts of personal observations that have not been well documented.
anesthesia: Loss of sensation, with or without loss of consciousness. angioplasty: Reconstruction of a blood vessel. anorexia: Loss of appetite. anorexia nervosa: Dangerous condition in which victims lose in-
terest in eating and become dangerously thin; usually associated with false beliefs about being too fat.
antacid: Over-the-counter product used to neutralize hydrochloric acid produced by the stomach.
anthroposophical medicine: Practices based on an occult philoso- phy said to relate man to his natural environment, with emphasis on color and rhythm.
antibodies: Protein molecules produced in the blood or tissues in response to a specific antigen, such as a bacterium, virus, or toxin. Antibodies destroy or weaken foreign invaders and neutralize organic poisons, thus forming the basis of immunity.
antigen: Substance that, as a result of coming in contact with ap- propriate tissues of an animal body, induces antibody formation.
antihistamine: Drug that counteracts histamine, a substance re- leased during allergic reactions that can cause localized redness, edema, and mucus production.
antimicrobial: Any substance that kills germs or inhibits their growth.
antioxidant: Agent that inhibits oxidation and thus prevents rancidity of oils or fats or the deterioration of other substances through oxidative processes. The best-known antioxidants are vitamins A, C, and E; beta-carotene; and the food preservatives BHA and BHT.
antipruritic: Substance that prevents or relieves itching. antipyretic: Drug that reduces fever. antiseptic: Substance that prevents the growth of disease-causing
microorganisms in or on living tissues. Antiseptics are used mainly to kill germs on the skin before puncturing the skin (for tests or injections) or surgery.
aphrodisiac: Substance claimed to increase sexual stimulation. aplastic anemia: Life-threatening disorder in which the bone
marrow fails to produce adequate numbers of circulating blood cells.
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applied kinesiology: Pseudoscience based on the belief that every organ dysfunction is accompanied by a specific muscle weakness.
arrhythmia: Irregular heart rhythm. arteriosclerosis: Chronic disease characterized by hardening and
thickening of artery walls. arthroscopy: Minimally invasive procedure in which an examina-
tion and sometimes treatment of damage of the interior of a joint is performed using an arthroscope, a type of endoscope that is inserted into the joint through a small incision.
aseptic: Devoid of microorganisms. assisted living: Term used to describe various types of residential
facilities that offer help with activities of daily living in a home- like atmosphere.
astigmatism: Uneven curvature of the cornea or surface of the lens of the eye, which distorts vision by preventing proper focus of light rays on the retina.
asymptomatic: Symptom-free. atherosclerosis: Accumulation of deposits of cholesterol and fibrous
tissue within the inner walls of large and medium-sized arteries; extensive buildup can result in blockage of the artery.
autism: A developmental disorder characterized by problems in social interaction, communication, and restrictive and repetitive interests and activities. It is most often identified between the ages of 18 and 30 months.
autism spectrum disorder (ASD): Term used to describe a group of pervasive developmental disorders that includes autism, As- perger’s syndrome, and other conditions that resemble autism but are not as severe.
autointoxication: Unfounded notion that intestinal contents stagnate and putrefy to form toxins that are absorbed by the body and cause chronic poisoning.
autonomic nervous system: Components of the nervous system that regulate many functions of the body that require no conscious effort. Autonomic nerves control the heart, smooth muscles, and glands.
ayurvedic medicine: Practices said to be based on a traditional Indian approach that combines herbs, “purifying” therapies, and “rejuvenation” techniques.
balance billing: Billing a patient for charges exceeding the amount approved by the patient’s insurance carrier.
balanced diet: Selection of a wide variety of foods from each of the food groups.
bile: Yellow or greenish fluid secreted by the liver, stored in the gallbladder, and passed into the small intestine, where it helps in the digestion and absorption of fats.
bioavailability: The extent to which a drug or nutrient becomes available within the body to affect metabolic and/or physiologic reactions.
bioequivalent: Term used to describe drug products with equivalent absorption and blood levels.
biofeedback: Relaxation technique using an electronic device that continuously signals pulse rate, muscle tension, or other body function by tone or visual signal.
bioflavonoid: Pigmented substance, not essential in humans, once thought to have vitamin activity. No evidence exists that biofla- vonoids are useful for the treatment of any human ailment.
biologic product: Preparation, such as a drug or antitoxin, that is synthesized from living organisms or their products and used medically as a diagnostic, preventive, or therapeutic agent.
biopsy: Removal and examination of a sample of tissue from a living patient for diagnosis or prognosis.
biorhythms: Pseudoscientific notion that human performance
and susceptibilities can be predicted by charting three biologic rhythms said to begin at the moment of birth.
biotechnology: Use of living organisms or their products to make or modify a substance.
bipolar illness: See manic-depressive psychosis. BMI (body mass index): Measure for classifying obesity, calculated
by dividing a person’s weight in kilograms by the square of the person’s height in meters.
board-certified specialist: Health professional who has completed accredited training and passed an examination given by a recon- ized specialty board.
board-eligible: Person who has the required training and experi- ence to take a certifying examination but has not taken or has not passed the examination. Although the American Board of Medical Specialties has officially abandoned the term, it is still in common use.
bodywork: Umbrella term for practices that include manual mas- sage, manipulation, or exercise of body parts.
bone scan: Diagnostic procedure in which a radioactive substance is injected intravenously and the image of its distribution to the bones is analyzed to detect certain diseases or conditions, most notably cancer.
bran: Outer coat of a cereal grain. Bran contains significant amounts of fiber and several nutrients.
cadaver: Dead body, especially one intended for dissection. calculus: Hard substance, such as a kidney stone, gallstone, or
the hard substance (calcified plaque) that can accumulate on the surface of teeth.
calorie: Unit that expresses the amount of energy the body is able to get from foods. Carbohydrates and proteins provide about four calories per gram, fats provide about nine calories per gram, and alcohol provides about seven calories per gram.
candidiasis hypersensitivity: Bogus diagnosis based on the notion that multiple common symptoms are the result of sensitivity to the common fungus Candida albicans.
capitation: Method of paying health-care providers according to the number of patients they agree to serve rather than the amount of service rendered per visit.
caplet: Drug tablet shaped like a capsule. carcinogenic: Cancer-causing. carcinoma: Malignant tumor of the epithelium. Epithelial cells
form the outer layer of the skin and line the gastrointestinal tract, the genitourinary tract, the glands, and other free surfaces within the body.
carcinoma in situ: Cancer that lies within the epithelium and has not invaded adjacent tissues. See carcinoma.
cardiorespiratory efficiency: Ability of the heart, blood vessels, and lungs to deliver oxygen to body parts.
cardiovascular: Pertaining to the heart and blood vessels. caries (dental): Tooth decay. carotene: Yellow pigment found in various plant and animal tis-
sues that is the precursor of vitamin A. An excessive amount of carotene can cause carotenemia, a condition in which the skin turns yellow.
catabolism: Metabolic breakdown of complex molecules into simpler ones, often resulting in a release of energy.
cataract: Cloudiness of the lens of the eye. caveat emptor: Phrase meaning, “Let the buyer beware.” caveat vendor: Phrase meaning, “Let the seller beware.” CCRC: Abbreviation for continuing care retirement community,
a facility that provides residents with health-related services pursuant to a contract either for life or a specified time period.
Glossary532
cease and desist order: Order given by a court or regulatory agency to stop unlawful activity.
cellulite: Medically unrecognized term commonly used to describe dimpled fat commonly found on the thighs of women.
cellulose: Main component of plant cell walls. A component of dietary fiber, cellulose absorbs water readily and helps make stools bulkier and softer.
cervix: Lower part of the uterus. An opening in the cervix connects the uterus to the vagina.
chakras: Alleged “energy centers” of the body that collect prana, the “life force” postulated in yoga (Hindu) philosophy.
CHAMPUS: Abbreviation for Civilian Health and Medical Pro- gram of the Uniformed Services, a federal insurance program for military dependents and retirees.
chemosurgery: Use of caustic chemicals to remove diseased or unwanted tissue.
Chinese medicine, traditional (TCM): Collection of practices that includes acupuncture, the use of herbs and dietary procedures, pulse diagnosis, and other procedures.
chiropractic: Conglomeration of practices, most of which are based on the faulty notion that spinal problems are the cause, or an underlying cause, of most health problems (see Chapter 9).
cholesterol level: Concentration of cholesterol in the blood, a factor that can help indicate the risk of heart disease.
chronic condition: Problem that lasts for a long period (at least 3 months) or recurs frequently.
chronic fatigue syndrome: Illness in which profound fatigue persists or recurs for at least 6 months and is accompanied by several flu-like symptoms, such as throat inflammation, lymph node enlargement, low fever, muscle and joint pains, headache, difficulty in concentrating, and exercise intolerance.
civil procedure: Noncriminal legal action such as an administrative hearing or a civil court action.
clinical: Related to the treatment or examination of patients (e.g., clinical study, clinical practice, clinical psychology).
clinical ecology: Pseudoscience based on a false belief that scores of symptoms are triggered by a global hypersensitivity to common foods and chemicals.
clinical trial: Investigation done to assess the safety and efficacy of a product (such as a drug) or medical procedure on humans.
closed-panel HMO: Insurance plan that covers services only from specified providers.
coagulate: To change from a liquid to a solid or gel; to clot. co-insurance: Partial payment beyond the deductible required from
the policyholder for services rendered. colonic irrigation: “High-colonic” enema performed with a rub-
ber tube inserted beyond the rectum. Large amounts of water are pumped in and out through the tube. The procedure is used without justification by proponents of “autointoxication.”
colonoscope: Instrument passed through the rectum to examine nearly the entire length of the large intestine.
comedo: Plug of dead cells and sebum within a hair follicle; the primary lesion of acne.
“complementary medicine”: Term used to refer to nonstandard methods used in addition to (but not instead of) standard treat- ments.
complete protein: Protein that contains significant levels of all of the essential amino acids.
complex carbohydrates (starches): Compounds composed of long chains of glucose molecules.
compounding: Creation of a drug product by mixing ingredients. comprehensive health insurance: Broad coverage that includes
most medical and surgical services in both inpatient and outpa- tient settings.
conditioner: Hair product intended to restore oils, sheen, elasticity, and manageability after washing.
confidentiality: Ethical principle that information disclosed during the course of treatment may not be revealed without the patient’s consent.
confirmatory test: Follow-up test after a positive result from an initial screening test. Confirmatory tests are usually more complex and expensive and often are more invasive than initial screening tests.
congenital: Present at birth. consent decree (or order): Court-approved agreement (usually to
stop behavior that has been challenged by a regulatory agency) that has the force of law.
Consumer Bill of Rights: Principles devised by President John F. Kennedy, who stated that consumers have the right to safety, to be informed, to choose, and to be heard.
consumer health: All aspects of personal enhancement, health maintenance, and consumer protection related to the intelligent purchase and use of health products and services.
continuing medical education (CME): Postgraduate educational activities aimed at maintaining, updating, and extending profes- sional skills. Many professional organizations, state licensing boards, and hospitals require CME participation.
contraceptive: Substance or device used to prevent pregnancy. contracture: Abnormal (usually permanent) shortening of a muscle
or scar tissue. A contracture can cause deformity and loss of joint mobility.
contraindication: Factor that makes it inadvisable to administer a drug or carry out a medical procedure.
coordination of benefits: Insurance policy provision that prohibits collecting benefits from two or more policies for medical care, thereby preventing policyholders from profiting from being ill. After the primary company pays, other companies will calculate their coverage of the remainder. All group policies contain a coordination clause, but most individual policies do not.
COPD: Abbreviation for chronic obstructive pulmonary disease. cornea: Transparent, outermost portion of the front of the eyeball. coronary: Pertaining to the heart. coronary heart disease (CHD): heart disease caused by narrowing
of the coronary arteries that supply blood to the heart muscle. corrective lenses: Eyeglasses or contact lenses that enable images
to be focused on the retina. cosmetics: Substances intended to be rubbed, poured, sprinkled, or
sprayed on the body to cleanse, increase attractiveness, or alter appearance.
cost-effective: Providing adequate benefit in return for its cost. counterirritant: Substance that produces mild irritation of the skin
that distracts attention from, and thus relieves, the discomfort of a deeper structure.
CPT codes: A system of code numbers for medical services and procedures. The numbers, which are used for insurance billing, are revised quarterly and are published annually in a book called Physicians’ Current Procedural Terminology.
crown: Portion of the tooth normally visible above the gum line. cryosurgery: Destruction of diseased or unwanted tissues by
freezing. CT scan: Imaging method in which the density of an area of the
body is determined by feeding x-ray data into a computer to create a picture on a screen similar to a cross-sectional photograph; used to study body structures. Also called CAT scan.
Glossary 533
cult: Any system that encourages obsessive devotion to a person, an ideal, or a set of dogmatic beliefs.
cystoscope: Instrument used to look inside the bladder and urinary passageway (urethra).
Daily Reference Values (DRVs): System of food component stan- dards intended to help consumers select food by reading labels wisely (see Chapter 10).
database: Organized compilation of information, usually maintained in a computer system.
decongestant: Drug that constricts blood vessels and membranes of the nose to relieve stuffiness.
deductible: Amount paid out of pocket before insurance coverage takes effect.
defensive medicine: Medically questionable use of procedures (such as x-ray examinations following minor head injuries) to protect the doctor in the event of a malpractice suit.
defibrillator: Device used to administer an electric shock to restart a heart that has stopped beating.
delusion: False belief, not ordinarily accepted by other members of the person’s culture, that is firmly held despite obvious proof or evidence to the contrary.
dementia: Chronic mental deterioration characterized by disorienta- tion; confusion; and impaired memory, judgment, and intellect.
dentifrice: Toothpaste, gel, or powder used in brushing teeth. denturist: Technician who provides dentures directly to the public
without supervision or referral from a dentist. Denturism is illegal in most states.
dermabrasion: Process that removes the upper layers of the skin to improve the appearance of scars.
dermatitis: Inflammation of the skin. diathermy: Generation of heat in tissue by electric currents for
medical or surgical purposes. Dietary Guidelines for Americans (DGA): General guidelines,
developed by the U.S. Departments of Agriculture and Health and Human Services, for people who want to decrease their chances of developing certain chronic diseases (see Chapter 10).
Dietary Reference Intakes (DRIs): Four sets of values that define what is known about the ranges of safe and adequate consumption of individual nutrients (see pages 181-182).
dietary supplement: See food supplement. dilate: Expand or widen. diopter: Unit of measurement of the refracting power of lenses;
the reciprocal of the focal length (in meters). Nearsightedness is designated with negative numbers (e.g., -3.00 D), whereas farsightedness is designated with positive numbers.
diploma mill: Nonaccredited organization that awards degrees and/or diplomas without requiring its students to meet educational standards for degrees established and traditionally followed by reputable educational institutions. Diploma mills that offer de- grees are also referred to as degree mills.
diplomate: Person who has passed an examination given by the National Board of Medical Examiners, a recognized examining or specialty board, or other recognized certifying body.
direct response advertising: Advertising that provides a phone number for further information or purchase of a product.
disorientation: State of confusion about time, location, or personal identity.
diuretic: Drug that increases the output of urine. DNR: Abbreviation for “Do Not Resuscitate,” a medical order to
refrain from cardiopulmonary resuscitation if a patient’s heart stops beating.
doctrine of signatures: Prescientific principle that the external characteristics (such as shape) of a plant, animal, or other entity signal its magical or healing properties and that relationships exist between the appearance of a source of medicine and the diseases against which it is effective.
dose-response: Gradient response in which exposure to progres- sively stronger doses produces a progressively greater effect. Two examples are increased sedation with higher doses of sleeping pills, and lung cancer rates that correlate with the number of packs of cigarettes smoked per day.
double-blind test: Experiment in which neither the experimental subjects nor those responsible for the treatment or data collection know which subjects receive the treatment being tested and which receive something else (such as a placebo).
DRGs (diagnosis-related groups): Categories created under Medi- care for payment of hospital bills according to the patient’s diag- nosis rather than the actual length of stay or treatment rendered.
DRIs: See Dietary Reference Intakes. drug (under federal law): Any substance intended to be used for
preventing, curing, mitigating, or treating a disease. durable medical equipment: Long-lasting piece of equipment,
such as a cane, wheelchair, respirator, or electric hospital bed. dysmenorrhea: Menstrual pain. DRVs: See Daily Reference Values. economies of scale: Cost savings resulting from aggregation of
resources or mass production. ECT: Abbreviation for electroconvulsive treatment. edema: Swelling of tissues as a result of the presence of abnormally
large amounts of fluid between the cells. elective procedure: Procedure (usually surgical) that does not need
to be done immediately to prevent death or serious disability. electroencephalogram (EEG): Record of the electricity of the
brain. The encephalography procedure is commonly referred to as a “brain-wave test.”
electrolytes: In physiology, various ions, such as sodium, potassium, or chloride, required by cells to regulate the electric charge and flow of water molecules across the cell membrane.
electrosurgery: Use of electricity to destroy benign lesions on skin. embryo: See fetus. emphysema: Chronic disease in which the ability to move air in
and out of the lungs is impaired. endometriosis: Condition, usually resulting in pain and dysmenor-
rhea, that is characterized by the abnormal occurrence of func- tional endometrial tissue outside the uterus.
endometrium: Lining of the uterus. endorphins: Narcotic-like substances produced by the body that
may relieve pain and produce euphoria. endoscope: Device that can be inserted into the body to look inside
a body cavity or organ. “energy medicine”: Term used by practitioners who claim to be
able to detect and manipulate “subtle energies” that cannot be measured with standard scientific instruments. This category includes the alleged energies involved in psychic healing, prayer, meditation, hope, faith, and the will to live. Energy medicine also is said to encompass acupuncture, electrodiagnosis, homeopathy, and magnet therapy.
enrichment: Addition of specific nutrients to a food to maintain established standards of identity for that food.
enteric coated (tablet): Tablet with a coating that delays release of the medication until the tablet has entered the intestine. This is done to prevent stomach irritation or inactivation of the medica- tion by stomach acids.
Glossary534
“environmental illness”: Term clinical ecologists use to describe what they consider “dysregulation” of the immune system. Its proponents claim that multiple symptoms can be triggered by hypersensitivity to common foods and chemicals.
enzymes: Protein substances that trigger and speed up (catalyze) chemical reactions within the body.
epidemiology: Study of the frequency, distribution, and determi- nants of diseases and disabilities and the impact of interventions in specific populations. Epidemiologic evidence can only show associations, not cause-and-effect relationships. However, if additional criteria are met, epidemiologists can infer that an as- sociated factor is causal.
epinephrine: See adrenalin. essential nutrients: Specific nutrients that cannot be synthesized
by the body and therefore must be obtained from food. estrogens: Female sex hormones involved in the development
of secondary sexual characteristics and in the maintenance of menstruation; estrogens are contained in birth control pills and may be administered to control menopausal or postmenopausal symptoms.
etiology: The causative process that leads to a health problem. evidence-based medicine (EBM): Medical care based on thorough
evaluation of scientific studies. expectorant: Drug that stimulates the flow of respiratory tract
secretions. extended care: Prolonged care (as in cases of prolonged illness or
rehabilitation from acute illness). fallopian tubes: Ducts through which ova can pass from each ovary
to the uterus. false-negative test result: Finding that wrongly indicates normality. false-positive test result: Finding that wrongly indicates an ab-
normality. family practitioner: See general practitioner. FDA fiscal year: Annual period that begins 3 months before the
calendar year. fee-for-service care: Professional care for which a fee is earned
for each service rendered, as opposed to payment through salary or capitation.
fermentable carbohydrates: Carbohydrates, such as sugars and starches, that can be split into relatively simple substances. In the mouth, saliva and the bacteria in plaque act on these carbohydrates to produce acids that can attack tooth enamel.
fetus: Human developing in the uterus from the end of the eighth week after conception to the moment of birth. (Before that the developing human is called an embryo.)
fiber (dietary): Plant constituents of food that are resistant to diges- tion by human gastrointestinal secretions; also called roughage. “Crude fiber” is what remains after laboratory breakdown of food with acid and alkali.
flatulence: Excessive intestinal gassiness. flexibility exercise: Stretching muscles to increase their range of
movement. fluoridation: Addition of fluoride to a community’s water supply
to prevent tooth decay in its users. food combining: Dietary practice based on the incorrect notion that
various food combinations eaten during the same meal can cause or correct ill health.
Food Guide Pyramid: Pictorial representation of U.S. govern- ment guidelines for healthy food selection. Replaced in 2011 by MyPlate (see Chapter 10).
food irradiation: Application of ionizing radiation (x-rays, gamma rays, or high-energy electrons) to foods to kill organisms, inhibit sprouting, or delay ripening.
food supplement: Ambiguous term for products used to provide nutrients in addition to those found in one’s diet. Most dietary supplements contain vitamins and/or minerals, but the Dietary Supplement Health and Education Act of 1993 includes herbs and many other nonnutritive substances in its definition of “di- etary supplement” (see Chapter 11). Various caloric products used for preventing or treating malnutrition are also referred to as supplements.
fortification: Addition of nutrients originally not present (or not present in significant amounts) to make the food more nutritious.
free radical: Atoms or groups of atoms having at least one unpaired electron, which makes them highly reactive.
functional foods: Processed foods containing ingredients that aid specific bodily functions in addition to being nutritious.
gangrene: Local death of tissue resulting from loss of blood supply. gastrointestinal tract: Digestive pathway, including the esophagus,
stomach, small intestine, and large intestine. general anesthesia: Agent, usually given by inhalation or intra-
venously, that produces unconsciousness and loss of sensation throughout the body.
general practitioner: Physician who provides a wide variety of services for patients of all ages but is not considered a specialist. Family practitioners offer the same range of services but undergo residency training and are considered specialists.
generic drug: Drug marketed under its simplified chemical name rather than a trade name. Most generic drugs are less expensive but therapeutically equivalent to their brand-name counterparts.
genetic engineering: Techniques of altering plants and animals by modifying their genes. Genetic manipulation has enabled commercial production of insulin, produced several types of hardy crop plants, and shown promise in the treatment of several diseases.
genital: Pertaining to sexual organs. gingivitis: Inflammation of the gums; the earliest stage of peri-
odontal disease. glaucoma: Disease in which pressure inside the eye increases; can
cause blindness if untreated. glucose: Simple sugar that is the basic form of food energy for life. glycogen: Form of glucose that is stored in the body (in the liver
and muscles) for use when energy is needed. grain: In pharmacology, a unit of weight equal to 65 mg. granola: Common term to describe various mixtures of oats, other
grains, fruits, seeds, and nuts. Although granola products are often promoted as “health foods,” many of them are high in calories and fat.
gross domestic product (GDP): Total monetary measure of a nation’s production of goods and services within the country during 1 year.
hair transplantation: Surgical grafting of hair-producing tissue from one part of the body to another; sometimes referred to as hair implantation.
hangover: Unpleasant physical effects that can follow heavy use of alcohol.
HDL (high-density lipoproteins): Substances in the blood that transport cholesterol from various cells to the liver, from which it can be excreted in the bile. Since this helps to protect blood vessels against heart disease, HDL is often referred to as “good cholesterol.”
“health freedom”: Slogan used to mischaracterize the freedom of consumers to chose health practitioners, practices, and products. Although it is desirable for consumers to be free to make informed choices, promoters of quackery use this slogan to oppose govern- ment actions that limit their ability to mislead consumers.
Glossary 535
health maintenance organization (HMO): Managed-care system in which enrollees or their employers pay premiums that cover treatment from designated providers.
heart failure: Inability of the heart to pump enough blood to meet the needs of the body.
Healthy Eating Index (HEI): A measure of diet quality that as- sesses conformance to federal dietary guidance. It is used by the U.S. Department of Agriculture to monitor the diet quality of the general population and the low-income subpopulation.
hematoma: A solid swelling of clotted blood within a body cavity or body tissues.
hemorrhage: Excessive bleeding. hepatitis: Inflammation of the liver. herb: Plant or plant part valued for its medicinal, savory, cosmetic,
or aromatic qualities. herniated (“ruptured”) disc: Protrusion of a degenerated or frag-
mented intervertebral disc into the space between the vertebrae through which the spinal nerves exit.
herpes infections: A group of acute or periodic skin eruptions caused by a virus. The conditions include cold sores (herpes sim- plex type I), genital herpes (herpes simplex type II), “shingles” in adults (herpes zoster), and chickenpox in children (herpes zoster).
heterosexual transmission (of disease): Transmission from male to female or from female to male.
HIPAA: Abbreviation for the Health Insurance Portability and Accountability Act of 1996, which protects patient privacy and access to insurance coverage for workers and their families.
HIV: Abbreviation for human immunodeficiency virus, the virus that causes AIDS.
holistic medicine: Treatment of the “whole person” (physical, psychologic, and spiritual); the term is often used to promote the use of a wide variety of unscientific methods, some of which focus just on specific body parts and neglect wholeness concerns.
homeopathy: Pseudoscience based on notions that (a) a substance that produces symptoms in a healthy person can cure ill people with similar symptoms and (b) that infinitesimal doses can be highly potent.
homocysteine: Amino acid that, when present in high levels in the blood, may indicate that the person is at risk for premature coronary heart disease and stroke (see Chapter 15).
hormone: Substance made in one part of the body that circulates through body fluids to exert its effect on another part of the body.
horoscope: Forecast alleged to predict a person’s future, based mainly on the relative positions of the stars and planets at the time of birth.
hospice: Program that enables terminally ill individuals to die as comfortably as possible in a homelike setting. Emotional support for the patient’s family may be included.
hypercholesterolemia: Medical term for high blood cholesterol level.
hypersensitivity: An objectively reproducible reaction to a sub- stance at a dose that normal people would tolerate.
hypertension: Medical term for high blood pressure. hyperthermia: Treatment method in which the temperature of the
body or a body part is raised. hypoglycemia: Low blood sugar. Physiologic hypoglycemia is
normal, moderate lowering of blood sugar in response to the body’s insulin and helps make a person feel hungry. Pathologic hypoglycemia is a rare condition in which severe symptoms are accompanied by very low blood sugar.
hysterectomy: Operation to remove the uterus.
iatrogenic: Adverse health problem caused by a medical examina- tion or treatment.
ibuprofen: Chemical (generic) name for the analgesic/anti-inflam- matory drug found in products such as Motrin and Advil.
ICD-9: Abbreviation for International Classification of Diseases, Ninth Revision, a system of diagnostic codes used for submitting insurance claims and for various statistical purposes.
idiopathic disease: Disease having no known cause. imaging procedures: Examinations that use x-rays, ultrasound,
radioactive chemicals, magnetic waves, or other modalities to visualize the structure or function of specified body parts.
impaired physician: Loosely defined term encompassing any form of physical, mental, or behavioral problem that interferes with a doctor’s ability to provide appropriate patient care. The problems can include unethical conduct, mental illness, senility, drug abuse, and/or failure to keep up-to-date.
in vitro: Performed in a test tube, tissue culture, or other artificial environment.
in vivo: Performed within a living organism. incidence: Proportion or rate of new cases of a disease or other
specified event that develops in a population during a specified period of time, usually 1 year.
indemnity insurance: With respect to health care, an insurance policy that provides benefits specified within a framework of fee schedules, exclusions, and limitations.
infertility: Inability to conceive or to carry a pregnancy to live birth. inflammation: Local tissue reaction consisting of swelling, red-
ness, and warmth. infomercials: Advertisements broadcast on radio, television, or
the Internet that typically last 2 minutes or longer and encourage viewers to respond by placing an immediate order.
informed consent: Permission given by a patient or experimental subject who has been fully apprised of the nature and risks of a proposed test or treatment.
injunction: Court order forbidding a particular act or acts. When an injunction is violated, the court has great leeway in ordering punishment.
inpatient: Person who is treated at a facility while in residence. insomnia: Inability to sleep. Institute of Medicine: Organization chartered in 1970 by the Na-
tional Academy of Sciences to examine policy matters pertaining to health.
integrated health networks: Corporate linkages of physicians, hos- pitals, and other health-care facilities into a system that provides comprehensive health care.
“integrative medicine”: Medical practice said to combine stan- dard medicine with selected “complementary” and “alternative” practices.
interferon: Protein molecule, made in tiny amounts by the body’s immune system, that helps the body combat viral diseases and possibly cancer.
intermediate care: Nursing home services that include supervi- sion by a registered nurse for at least one 8-hour shift per day for patients capable of performing some activities of daily living.
international unit (IU): An amount defined by the International Conference for Unification of Formulae—used to express the quantity of certain vitamins, enzymes, and other substances.
internship: Period of supervised clinical training. interstate commerce: Economic transactions involving participants
or products from two or more states, which means they are subject to federal laws.
Glossary536
intervertebral discs: Structures between the vertebrae that give the spine mechanical strength and cushion the bones. The discs are tough on the outside and jellylike on the inside.
intramuscular injection: Injection into a muscle. intraocular lens: Plastic lens used to replace an abnormal lens
(cataract) of the eye. intradermal: Administered into the skin. intravenous: Administered into a vein. iridology: Pseudoscience based on the theory that most body ab-
normalities cause abnormal markings in the eye. isokinetic exercise: Muscle contraction in which the maximum
contraction is generated as the muscle contracts at constant speed throughout the full range of motion.
isometric exercise: Contraction of muscles with little or no move- ment of body parts.
isotonic exercise: Muscular action in which there is a change in muscle length while keeping tension constant (as occurs with lifting free weights).
-itis: Suffix that means inflammation or “disease of.” JAMA: Abbreviation for the Journal of the American Medical
Association. jaundice: Yellowish pigmentation of the skin, eyes, and other tissues
caused by accumulation of bile pigments in the tissues. JCAHO: Commonly used abbreviation for the Joint Commission on
Accreditation of Healthcare Organizations, formerly called Joint Commission on Accreditation of Hospitals (JCAH). Although others often abbreviate its name as “JCAHO” the organization refers to itself as “the Joint Commission.”
joint: Place where bones meet. Most joints permit movement. ketosis: Abnormal metabolic state brought about by incomplete
breakdown of fatty acids into ketone bodies; may result from low-carbohydrate or starvation diet.
kickback: Illegal payment made to someone who refers work to the payer.
kinesiology: Study of the mechanics and anatomy of motion and the functions of muscles; a respectable science, as distinguished from “applied kinesiology,” a pseudoscientific system of diagnosis and treatment described in Chapter 11.
labeling (legal definition): Written, printed, or graphic matter displayed on packages or accompanying a food, drug, device, or cosmetic.
laparoscope: Instrument that can be inserted into the abdominal cavity to visualize its contents or perform surgery (such as female sterilization or gallbladder removal).
latent: In a dormant or hidden stage. LDL (low-density lipoproteins): Substances that contribute to fatty
deposits (atherosclerosis) in the major arteries and are associated with increased risk of atherosclerosis. For this reason they are often called “bad cholesterol.”
legumes: Group of protein-rich vegetables that includes peas and beans, including black beans, black-eyed peas, broad beans, chick peas, kidney beans, lima beans, pinto beans, soybeans, lentils, split peas, and peanuts.
lesion: Abnormal change in the structure of an organ or body tis- sue resulting from injury or disease, especially a change that is circumscribed and well defined. Examples are cuts, burns, skin eruptions, and tumors.
leukoplakia: Precancerous condition in which thickened white patches occur on mucous membranes, most commonly those of the tongue, mouth, or female genitalia.
life expectancy: Average number of years that people of a certain age are likely to live.
ligament: Sheet or band of tough, fibrous tissue that connects bones or cartilages at a joint or supports an organ.
lipid: Chemical term for any of a class of organic compounds that are fatty acids or their derivatives and are insoluble in water but soluble in organic solvents. They include many natural oils, waxes, and steroids.
living will: Document indicating which treatments the signer would or would not want if rendered permanently unconscious or ter- minally ill and unable to communicate.
long-term care: The continuum of broad-range maintenance and health services to chronically ill, disabled, or mentally retarded persons. Services may be provided on an inpatient (rehabilitation facility, nursing home, mental hospital), outpatient, assisted liv- ing, or at-home basis.
loss ratio: Percentage of premium dollars an insurance company pays in benefits to policyholders; also called benefit-cost ratio.
macrobiotic diet: Restricted diet, high in whole grains, claimed by its advocates to improve health and prolong life.
macronutrient: Nutrient needed in large amounts. major medical insurance: Coverage (beyond basic coverage) to
offset heavy medical expenses from prolonged illness or serious injury.
malaise: Medical term for general discomfort or uneasiness, which often is an early sign of illness.
malocclusion: Improper alignment of the jaws or teeth. malpractice: Failure of a professional to provide services that meet
prevailing standards of care. managed care: Health-care system (such as HMO or PPO) that
integrates the financing and delivery of services by using se- lected providers, utilization review, and financial incentives for members who use the providers and procedures authorized by the plan.
mania: Excitement of psychotic proportions manifested by mental and physical hyperactivity, disorganized behavior, and/or eleva- tion of mood.
manic-depressive psychosis: Mental impairment characterized by recurrent periods of mania, depression, or both. Also called manic-depressive illness or bipolar illness.
margin of safety (of a drug): Difference between a therapeutic dose and a toxic dose. The wider the margin, the safer the drug.
marker (also called biomarker): Something that reflects the sever- ity or presence of a disease state. Some markers are substances in the blood that can be measured to predict the effect of a treatment or monitor its progress.
media: Information sources, including radio, television, newspapers, magazines, books, newsletters, pamphlets, and the Internet.
Medicaid: Federally subsidized, state-run program of health care for indigent persons.
medically indigent: Term referring to people who have enough money for most expenses but are unable to pay for sudden high costs of health care. Most medically indigent individuals are employed but cannot afford (or cannot obtain) adequate health insurance.
Medicare: Federal health insurance program for persons 65 years of age or older and for certain disabled younger persons.
megavitamin therapy: Nonstandard treatment using high dosages of vitamins, usually 10 times the RDA or more.
menopause: Period of life during which menstruation normally stops—often referred to as “the change of life.”
meridian therapy: Term that encompasses acupuncture, acupres- sure, and other techniques claimed to balance the flow of the body’s “life force.”
Glossary 537
meta-analysis: A type of systematic review in which research reports are evaluated by listing desirable attributes, assigning points to each, and scoring each report accordingly. Data from well-designed studies may also be pooled for further statistical analysis.
metabolic therapy: A loosely defined, unorthodox program that may include megadoses of vitamins, oral enzymes, pangamic acid, coffee enemas, and a low-protein diet.
metabolism: Sum of the physical and chemical processes by which the body is maintained; also, the reactions involved in energy production.
metastasis: Transfer of disease-causing microorganisms or can- cerous cells from an original (primary) site to one or more sites elsewhere in the body, usually through blood vessels or lymphatic channels. Secondary cancer is called a metastasis or metastatic tumor.
METs (metabolic equivalents): A measure of the intensity of physical activity. METs are multiples of the resting metabolic rate, which can be expressed in terms of total oxygen consump- tion or oxygen consumption per unit of body weight. One MET is the amount of oxygen consumed while a person sits quietly at rest: approximately 3.5 mL of oxygen per kilogram of body weight per minute.
micronutrient: Nutrient needed in only very small amounts. misbranding: Misrepresentation, as defined by the Federal Food,
Drug, and Cosmetic Act, in the labeling or advertising of a food or drug.
miscarriage: Premature expulsion of a nonviable fetus from the uterus. Also called spontaneous abortion.
MMR: Abbreviation for measles, mumps, and rubella (German measles).
morbidity: Any departure from a state of physiologic or psychologic well-being. Incidence and prevalence are measures of morbidity in populations.
mortality (of a disease or injury): Measure of the frequency of death in a defined population during a specified period of time, usually 1 year.
mucous membrane: Mucus-producing tissue that lines the body’s air passageways and digestive tract.
naprapathy: Variation of chiropractic based on the philosophy that contractions of the body’s soft tissue cause illness by interfering with neurovascular function.
National health insurance (NHI): A federal government-regulated health insurance program for all or nearly all citizens.
National Research Council: Principal operating agency of the National Academy of Sciences and the National Academy of Engineering. It is a private, nonprofit institution that provides science and technology advice under a congressional charter.
natural hygiene: Philosophy of health and “natural living” that emphasizes fasting and food combining; see food combining.
naturopathy: Pseudoscientific approach to health care based on the belief that the basic cause of disease is violation of nature’s laws.
necrotic tissue: Dead tissue. negative test result: Test result that indicates no abnormality. neurotic reaction: Nervous response, resulting from inner emo-
tional conflict, in which the person generally remains able to distinguish what is real from what is not.
new drug: Drug that is not generally recognized by experts as safe and effective (see safe and effective). Drugs cannot be legally marketed in interstate commerce unless they have FDA approval or are generally recognized as safe and effective for their intended
use. Intended use can be determined from claims in labeling, advertising, or other promotional channels.
nocebo effect: Unfavorable treatment response that does not result from pharmacologic effect or other direct physical action; opposite of the placebo effect.
nosocomial infection: Infection acquired during hospitalization. nutrient density: Relative concentration of nutrients in the diet,
which can be expressed as nutrients per calorie. Foods relatively high in vitamins and minerals and low in calories are said to be nutrient-dense.
nutripathy: Pseudoscience in which urine and saliva tests are used to detect “energy imbalances” that supposedly are correctable with various supplements and special formulas. The data are interpreted using “a mathematical formula for perfect health, based on the biologic frequencies of living matter.” The formula was developed by Carey Reams, a self-proclaimed biophysicist who was prosecuted during the 1970s for practicing medicine without a license.
obese: Overweight as a result of excess fat (see Chapter 12). obsessive-compulsive disorder: Mental problem in which people
have recurrent ideas, thoughts, images, or impulses that they know are irrational but cannot control. They also may engage in repetitive actions, such as excessive handwashing, that they recognize as irrational.
occlusion: Act of closure or state of being closed or obstructed. In dentistry the term refers to the contact between upper and lower teeth (e.g., malocclusion). In medical practice it is used to describe blockage of a body passageway such as a blood vessel or duct.
occult blood: Blood in the feces in amounts too small to be seen but detectable by chemical tests.
off-label use: Prescription of a drug for a purpose that is not FDA- approved.
ombudsman: Someone who investigates complaints, reports find- ings, and mediates fair settlements, especially between aggrieved parties. In some hospitals patient representatives fill this role.
oncologist: Physician who specializes in the treatment of cancers. online: Connected to a computer’s central processing unit or to a
computer network so that databases and/or other stored informa- tion are accessible.
open panel: Prepaid insurance plan in which any physician (or other covered type of health professional) can become a provider under the plan.
opportunistic infection: Infection by an organism that normally is harmless but is able to thrive when an individual’s immunity is impaired by a serious disease (such as cancer or AIDS) or by treatment with drugs that suppress the immune system.
orthomolecular treatment: Dubious treatment method claimed to treat diseases by administering the “right” nutrient molecules (e.g., vitamins, minerals) at the right time; also called meganutrient therapy.
osteopath: Physician who is a graduate of an osteopathic medical school. Osteopathy was originally based on false beliefs but gradu- ally abandoned them and incorporated the theories and practices of scientific medicine.
osteoporosis: Thinning of the bones, common in postmenopausal women.
otitis: Inflammation of the ear. Otitis media, the most common cause of earaches, is an inflammation of the middle ear.
outcomes research: Studies to determine whether health-care interventions meet predetermined criteria.
outpatient: Person who is treated at a facility without residing there.
Glossary538
over-the-counter (OTC) drugs: Nonprescription drugs. overweight: Weighing more than the amount listed in a standard
height-weight table. ovulation: Release of a mature egg from an ovary. palliative care: Treatment that lessens symptoms but is not intended
to cure or alter disease progression. palpate: To examine by touching with the hands. palpitation: Noticeably forceful heartbeat. paradigm: Model or overall understanding of how things work.
An example of a faulty paradigm is the claim by “alternative” practitioners that disease is caused by body “imbalances” or “weaknesses” that their various methods can correct.
paranormal: Not measurable or explainable by currently accepted scientific methods or theories.
partial hospital: An outpatient psychiatric facility where patients spend 6 to 8 hours a day in a therapeutic atmosphere. Such fa- cilities can avert hospitalizations and help hospitalized patients readjust to community living.
patent approval: Government recognition that a product or process differs from previous ones, but not evidence that the product works as claimed.
patent medicine: Obsolete term for medicine with a formula that was protected from being copied by a patent from the U.S. Pat- ent Office.
patient package insert (PPI): Leaflet that tells how to use a drug; includes information on the drug’s purposes, hazards, and side effects.
Patient’s Bill of Rights: Lists of ethical principles that define considerate and ethical treatment in a hospital or nursing home.
pedal: Pertaining to the foot. peer review: Formal review of clinical work, records, insurance
claims, manuscripts, or research by colleagues who are assumed to have equal knowledge. The process is used by insurance companies, managed-care programs, scientific journals, research sponsors, and hospital committees.
percussion: Technique of physical examination in which a body part, usually the chest or abdomen, is tapped with the hand in order to produce a sound that reflects the density of the underly- ing organ(s).
periodontal disease: General term for inflammatory and degenera- tive diseases of the gums and other structures that surround the teeth and attach them to their sockets. The word “periodontal” comes from two Greek words meaning “around the tooth.”
pharmacognosy: The science of medicines from natural sources. photochromatic: Term applied to some eyeglass lenses that lighten
or darken in response to the amount of ultraviolet light present. phrenology: Pseudoscience based on the belief that the contours
of the skull reflect the person’s mental faculties and character. physical dependence: Physiologic state in which “withdrawal”
symptoms are likely to develop when use of a drug is decreased or stopped.
phytochemical: Chemical constituent of a plant. placebo: Inert substance given with the hope that it will relieve
symptoms or used as a control in an experiment that tests whether something else is effective.
placebo effect: Favorable treatment response that does not result from pharmacologic effect or other direct physical action.
plantar: Pertaining to the sole of the foot. plaque (atherosclerotic): Deposit that builds up on the inner wall
of an artery; see atherosclerosis. plaque (dental): Soft, sticky, colorless, almost invisible film that
continuously forms on the teeth and contains bacteria that cause dental decay and periodontal disease.
plasma (blood): The clear, yellowish fluid portion of blood in which the blood cells are suspended.
platelet: Tiny blood cell that promotes clotting. point of service (POS) plan: Managed care that covers treatment
by an HMO physician but permits patients to seek treatment else- where with a higher co-payment. Patients do not have to choose how to receive services until they need them.
portal of entry: Health-care provider to whom patients have direct access (without referral from another provider).
positive test result: Test result suggesting that something is ab- normal.
potentially preventable readmission (PPR): A hospital readmis- sion that is clinically related to the initial admission and might have been prevented by (a) provision of quality of care in the hos- pital, (b) adequate discharge planning, (c) adequate post-discharge follow-up, or (d) improved coordination between hospitals and providers outside of the hospital setting.
PPACA: Abbreviation for the Patient Protection and Affordable Care Act (see Chapter 23).
precertification: Component of managed care in which a plan rep- resentative must authorize use of a procedure in order for it to be covered by the plan; also called preauthorization. Precertification is required most often for nonemergency hospital admissions, elective surgery, or psychiatric care.
precursor: Substance from which another substance is derived; commonly used to describe an inactive substance that is converted into an active enzyme, vitamin, or hormone. Beta-carotene, for example, is a precursor of vitamin A.
preferred provider organization (PPO): Prepaid insurance plan in which member hospitals and/or physicians contract with a third-party payer to deliver services for negotiated fees, usually at a reduced rate. Beneficiaries may seek care from nonmember providers, but if they do, the out-of-pocket cost is likely to be higher.
premenstrual syndrome (PMS): Combination of physical and/or emotional symptoms that occur before menstruation and disap- pear or become minimal during menstrual periods; also called premenstrual tension (PMT).
prenatal care: Care of a pregnant woman before birth occurs. prescription drugs: Drugs that cannot be obtained unless ordered
by a physician or other designated health professional. prevalence: Number of cases or events in a given population at a
specific point or during a specific period of time. primary-care provider: Health-care professional who provides
basic health services, manages routine health-care needs, and is usually the first contact when someone needs care—typically a family practitioner, internist, or pediatrician.
prognosis: Likely course of an ailment. proprietary drug: Drug owned by a private individual or corpora-
tion under a trademark or patent. prostaglandins: Group of physiologically active substances, pres-
ent in many tissues, that can stimulate the muscles of the uterus, intestinal wall, lungs, and blood vessels.
prosthesis: Artificial device to replace a missing body part, such as an eye or a leg.
protocol (experimental): Written description of the background, objective, design, and intended interpretation of an experiment.
pseudoscience: Theory or methodology that is represented as sci- entific but lacks a basis in science. Its proponents typically use scientific terminology and concoct evidence (or distort scientific findings) in support of their beliefs.
psychic healing: Alleged healing through exertion of mystical forces without the use of any physical curative agent.
Glossary 539
psychic surgery: Sleight-of-hand fakery by individuals who pretend to remove diseased organs during “surgical procedures” that leave the skin intact.
psychomotor retardation: Slowing of the activity of the mind and body, a common finding in severe depression.
psychoneuroimmunology: Hodgepodge of theories and practices based on the idea that brain functioning affects the immune system in ways that positive thinking can modify.
psychosis: Severe form of mental disturbance in which contact with reality is impaired.
psychosomatic (or psychophysiologic): Pertaining to the effect of emotions on the body.
psychosurgery: An operation that relieved severe nervous symp- toms by severing selected nervous pathways within the brain. It became obsolete as modern psychiatric drugs were developed.
psychotherapy: Conversational method used to treat emotional problems.
psychotropic drug: Medication capable of altering someone’s mood, perception, or behavior.
puffery: Advertising that uses vague superlatives, exaggerations, or subjective opinions without specific facts.
pyorrhea: Condition in which pus oozes from an infected area, as it may in advanced cases of periodontal disease. The term is sometimes used (mainly by advertisers and laypersons) as a synonym for periodontal disease.
quackery: Promotion of an unproven health product or service, usually for personal gain.
radiograph: Image produced by x-rays passing through the body. radiopaque: Not allowing the passage of x-rays or other radiation.
Radiopaque substances appear white on x-ray films. RDAs (Recommended Dietary Allowances): Levels of certain
nutrients considered adequate to meet the needs of practically all healthy persons.
RDIs (Reference Daily Intakes): Set of dietary references based on the RDAs for essential vitamins and minerals and, in selected groups, protein.
rebound (from a medication): Situation in which stopping a medication produces a withdrawal reaction opposite to that of the medication. Stopping overuse of nosedrops, for example, can cause rebound congestion.
reflexology: Pseudoscience based on beliefs that each body part is represented on the hands and feet and that pressing on the hands and feet can have therapeutic effects in other parts of the body.
regulatory letter: Letter from the FDA warning a seller to stop breaking the law. If corrective action is not taken promptly, the FDA may initiate a seizure or seek an injunction.
remission: Abatement or subsiding of the symptoms of a disease; also, the period during which the signs and symptoms of a disease disappear or are less severe.
renal: Pertaining to the kidney. respiration: Medical term for breathing. respirator: Device for maintaining artificial respiration. retina: Light-sensitive membrane at the back of the eye. risk-benefit analysis: Comparison of the likely benefits and risks
of various courses of action (such as undergoing a medical treat- ment or doing nothing).
risk factor: Habit, trait, or condition that is associated with increased probability of getting a particular disease, such as atherosclerotic heart disease, cancer, or osteoporosis.
roots (of a tooth): Lower portions of the teeth below the gum line. rubella: German measles. safe and effective: Legal term used by the FDA to describe drugs
that are generally recognized by experts as both safe and effective. Drugs recognized as safe or effective but not both are still con- sidered “not safe and effective.”
salt sensitivity: Tendency toward abnormal elevation of blood pressure in response to salt (sodium) intake.
schizophrenia: Any of a group of psychotic disorders typified by disordered thinking, withdrawal from reality, delusions, hal- lucinations, and/or various other patterns of disturbed emotions or behavior.
science-based medicine: An approach that goes beyond the usual standards of evidence-based medicine by considering plausibility in addition to evidence from clinical trials.
scientific method: Principles and procedures for the systematic pursuit of knowledge, involving data collected through observa- tions and experiments, formulation and testing of hypotheses, and peer review.
screening test: Method to detect an unrecognized health problem by sorting out apparently well people who probably have a specific problem from those who probably do not. Abnormal or equivocal findings indicate that further evaluation is needed.
secondary care: Services provided by medical specialists (such as general surgeons) who usually see patients by referral from primary care providers.
self-help groups: Groups of laypersons who help each other cope with specific problems.
semen: Whitish fluid that carries a male’s sperm cells (spermatozoa). sensitivity (of a test): Likelihood that a test will correctly identify
people having the condition that the test is intended to detect. A highly sensitive test will detect all or nearly all with the condition and will have few false-negative results.
serum: Fluid portion of the blood obtained after removal of blood cells and fibrin clot.
“set point” theory: Theory that the body naturally gravitates toward a given weight (largely determined by genes), as if it were set by a thermostat.
sexually transmitted diseases (STDs): Diseases caused by organ- isms transmitted from one person to another through intimate (usually sexual) contact.
shared decision-making: Process in which clinicians and patients jointly (a) discuss the risk or seriousness of the disease or con- dition; (b) discuss any proposed services, including the risks, benefits, alternatives, and uncertainties; (c) weigh their values regarding the potential benefits and harms; and (d) choose what makes them feel most comfortable.
side effect: Effect of a drug that is undesirable or unrelated to the main reason for which it is prescribed.
SIDS: Sudden infant death syndrome. sigmoidoscope: Hollow tubular instrument that can be passed
through the anus into the rectum and part of the large intestine for diagnostic or therapeutic purposes.
simple carbohydrate: Sugar composed of one or two sugar mol- ecules.
single-payer system: Centralized health-care payment system in which one entity, such as the federal government, pays for all health-care services. The best-known example is the Canadian health-care system.
skilled nursing: Rehabilitative inpatient services that include 24- hour nursing coverage.
specificity (of a test): Likelihood that a “positive” test indicates that an individual has the specific condition that the test is intended to detect. A highly specific test will have few false-positive results and often will establish the diagnosis.
Glossary540
speculum: Tubular instrument used to look into an opening of the body, such as the nose, ear, or vagina.
sphygmomanometer: Instrument for measuring blood pressure. spontaneous remission: Recovery from illness without treatment. sprain: Stretch or tear of a ligament. STD: Abbreviation for sexually transmitted disease; formerly called
VD (venereal disease). stenosis: Narrowing of a body passageway such as an artery or duct. strain: Stretch or tear of a muscle. stress test (exercise test): Evaluation in which an electrocardiogram
is taken during gradually escalated exercise. stroke: Sudden, disabling attack caused by interruption of blood
supply to the brain. subcutaneous: Under the skin. sun protection factor (SPF): Number indicating how much protec-
tion a sunscreen product provides against ultraviolet rays. The SPF number is a multiple of the exposure time it would take to burn unprotected skin. For example, it would take 15 times as long to burn when wearing an SPF 15 sunscreen than when using no sunscreen.
suppository: Drug product administered by insertion into a body opening, usually the rectum or vagina, where it melts to release its active ingredient(s).
synthesis: Formation of compounds by combining simpler com- pounds or elements.
systemic: Term referring to the body as a whole rather than to a part of the body.
tendon: Band of tough, inelastic fibrous tissue that connects a muscle to a bone or other structure.
TENS device: Battery-powered device that delivers an electric current to an area of the body to relieve certain types of pain.
tertiary care: Services provided by highly specialized providers (such as medical subspecialists) who see all or most of their patients upon referral by primary- or secondary-care providers.
tertiary-care center: Hospital or medical center that offers highly specialized care for severe health problems.
testable hypothesis: Prediction that specific circumstances will produce specific, observable results. Such hypotheses must also be falsifiable (disprovable by negative evidence).
testimonial: Claim by the user that a treatment method has been effective; not a reliable form of evidence.
thermography: Imaging procedure based on the measurement of heat radiating from the body’s surface. Scientific practitioners consider thermography unreliable, but it is popular among chi- ropractors.
third-party payer: Payment source other than patient or provider (e.g., insurance company or government program).
TMJ (temporomandibular joint): The jaw joint, which is located in front of the ear near the external ear canal.
tolerance (to a drug): Adaptation to a drug in which higher doses are needed to achieve the effects previously produced by lower doses.
topical use (of a drug): Application to a body surface. traditional: Mode of thought or behavior that passes from one
generation to another. Unscientific practitioners often use this term to describe scientific medicine and to imply that its beliefs (unlike theirs) are rigidly held. This usage is incorrect because medical science evolves in response to valid research.
traditional Chinese medicine (TCM): See Chinese medicine, traditional.
trans fatty acids: Unsaturated fatty acids that contain one or more double bonds in which the hydrogen ions attached to the carbon atoms at the double bond are on opposite sides of the molecule.
treatment planning: Formal process whereby various staff mem- bers of a health-care facility meet regularly to discuss patients, set goals, record the steps necessary to reach the goals, and evaluate the progress of the patients. It is required for the accreditation of psychiatric facilities.
tremor: Abnormal trembling or shaking of a body part. tubal pregnancy: Development of an impregnated egg in a fallopian
tube (the duct that goes from an ovary to the uterus). ultrasound device: Mechanism that transforms electrical energy
into sound energy for use in diagnosis, surgery, dental care, or other therapeutic procedures.
unbundling of fees: Billing separately for components of services that should be billed as a single procedure.
United States Pharmacopoeia (USP): Authoritative volume on drugs that contains the official standards for identity, strength, and purity.
unnecessary surgery: Operation performed without a realistic expectation that it will improve the quality or length of a pa- tient’s life.
upcoding: Use of a procedure code to falsely represent that a medical service was more extensive than actually rendered.
USDA: Abbreviation for U.S. Department of Agriculture. utilization review: Review, based mainly on medical records,
intended to determine the quality and necessity of services pro- vided to the patient.
varicella-zoster virus: Causative agent for chickenpox in children and “shingles” in adults.
varicose veins: Abnormally swollen or dilated veins. vascular: Pertaining to blood vessel(s). vegan: Strict vegetarian; one who eats no products of animal ori-
gin (e.g., red meat, poultry, fish, eggs, milk, cheese, and milk products).
vertebra: Bony segment of the spine that encircles and helps protect the spinal cord and nerves. The plural of vertebra is vertebrae.
vertically integrated system: Health-care system that provides primary care, specialty care, and hospital care under one umbrella.
viscera: The soft internal organs of the body, especially those contained within the abdomen and chest.
visual training: Unscientific system of eye exercises claimed to strengthen eyesight and improve learning disabilities.
vitalism: The concept that organisms function because of a “vital principle” or “life force” distinct from the physical forces explain- able by the laws of physics and chemistry. Health systems based on this notion (e.g., naturopathy, homeopathy, and traditional chiropractic) maintain that diseases should be treated by “stimu- lating the body’s ability to heal itself” rather than by “treating symptoms.”
withdrawal reaction: Symptoms and physiologic changes that occur following stoppage or reduced use of a drug upon which someone has become physically dependent.
yo-yo dieting: Repeated weight-loss (through dieting) followed by weight gain; also called weight cycling.
Index
A AARP, 62, 419, 520 Abdominal toners, 273t, 275 Abortion, voluntary, 410 AboutHerbs, 215t Abrams, Dr. Albert, 433 Abravanel, Dr. Elliot, 243 Academy of Certified Social Workers
(ACSW), 91 AcaiPure, 251 Accardo, Pasquale, 13 Accepting assignment, 483 Access to Medical Treatment Act, 158 Accreditation, 9, 9t, 21, 530 of acupuncture schools, 21, 143 of ambulatory surgical centers, 457 of chiropractic schools, 21, 143, 168 of health-care facilities, 454 of hospitals, 81, 454, 455, 457–458 limitations of, 143 of managed-care organizations, 477–478 of medical schools, 66 of naturopathic schools, 21, 143, 144 of pharmacy schools, 351 of urgent care centers, 456 Accreditation Association for Ambulatory
Health Care (AAAHC), 454 Accreditation Commission for Acupuncture
and Oriental Medicine (ACAOM), 143 Accreditation Council for Pharmacy
Education, 351 Accreditation Council of Continuing
Education (ACCME), 21–22, 530 Accutane, 385–386 Acesulfame K, 247 Acetaminophen, 360, 362, 362t, 530 Acidophilus, 209t Acidosis, 530 Acne, 384–386 Acne cure software, 386 Acquired Immunodeficiency Syndrome; see
under HIV/AIDS ACSM Fitness Book, 264 Actinomyces bovis, 336 Activated charcoal, 209t Activities of daily living (ADLs), 530 Acupressure, 105, 141, 220, 302t, 530 Acupressure earrings, 250 Acupuncture, 141–143, 530 anesthesia, 142 points, 141–142
reasons to avoid, 144 regulation, 143 research, 142 risks, 142–143 and smoking cessation, 290 Acute condition, 530 Adams, Samuel Hopkins, 506 Addiction, 530 to amphetamines, 243 help for, 92, 96–97 to cigarettes, 289 Additives color, in cosmetics, 380, 505, 513 food, 101, 392, 505, 509–510 Adequate intake (AI), 181 Administrative complaint, 530 Administrative medicine, 530 Adrenal insufficiency, 154 Adrenaline (epinephrine), 296, 430, 530 Advance directives, 438–441, 459, 530 durable power of attorney for health care (DPAHC), 438, 439 living will, 438, 439, 536 for mental health care, 96 Advertising and other promotional
activities, 45–64 alcohol, 4, 46 antioxidant, 202 “cancer cure” ad, 335 chelation therapy, 157 chiropractic; see Chiropractors, advertising cigarette, 4, 46, 53–54 complaints, where to send, 522t consumer motivation, 46 corrective, 516 cosmetic, 46 costs, 49 dental, 49, 50, 127 dietary supplements, 54–57, 56t direct response, 533 ergogenic aids; see “Ergogenic aids” exercise and fitness products, 60, 276 food, 4, 54, 315 FTC regulation, 49, 55–57, 63, 515–517 hair analysis, 239–240 health claims on food labels, 189t,
190–191, 190t homeopathic products, 56t, 140 hospital, 50–51 industry self-regulation, 62–63 influence on magazine contents, 23
infomercials, 57, 60–61, 63 “low-carb” products, 242 “low cholesterol” claims, 189t, 315 mail order; see Mail-order frauds medical ethics and, 49 misleading nature of, 23, 35, 46–49 misuse of statistics, 16–17 mouthwash, 118 multilevel marketing; see Multilevel
marketing National Advertising Review Board, 62–63 “net impression” of messages, 55 nonprescription drugs, 53, 359 “nutrition insurance,” 56t, 199–200, 201t orange juice, 56t osteopathic, 69 outlets, 49 patent medicine, 356–357 penis enlargement, 398–399 prescription drug, 51–53 professional, 49–51 psychologic manipulation, 46–48, 53 puffery, 6, 48 purpose of, 46 Rodale Press, 223 sauna devices, 277–278 targeting of women, 53 techniques commonly used, 4, 46–48, 47t telemarketing schemes, 62 tobacco products, 4, 53–54 vitamin, 22, 23, 46, 201t weasel words, 4, 48 weight-related claims, 6, 59 youth and beauty aids, 59–60 Aerobic exercise, 262, 530 AFP Tetra, 413 Ageless Body, Timeless Mind, 135 Agency for Health Care Policy and
Research (AHCPR), 18, 170 Agency for Health Care Research and
Quality (AHRQ), 18 AIDS; see HIV/AIDS Air abrasion, 123 Air cleaners, 291 Air quality, indoor, 291–292 Akavar 20/20, 59 Alcohol caloric content, 531 and cancer, 119, 331, 333 danger during pregnancy, 289 dietary guideline, 180t
Index542
Alcohol—cont’d. drug interactions with, 365 and heart disease, 289, 319 and HDL, 319 “moderate intake,” 319 and NSAIDs, 363 in OTC drugs, 355 in patent medicines, 356 and sleep disturbances, 371, 372 and stroke, 320–321 Alcoholics Anonymous, 97, 301 Alfalfa, 209t Alive & Well AIDS Alternatives, 5 Alivizatos, Dr. Hariton, 341 Alkalosis, 530 Allergen, definition, 530 Allergic conditions, 295–296, 530 and electrodermal skin testing, 139 desensitization shots, 295–296 latex allergy, 430 Alli, 243 Alliance for Natural Health USA, 158 Allicin, 214t Allied health care personnel, 71t, 112–113 Allopathy, 137, 530 Aloe vera, 209t, 382t Alopecia, 388, 530 Alpha hydroxy acids, 382 AltCareDex System, 215t “Alternative agriculture,” 207 “Alternative” health care, 5, 133, 530;
also see under “Complementary and alternative medicine” (“CAM”)
Alternatives to Abortion, 410 Altschul, Dr. Aaron, 255 AMA; see American Medical Association “Amalgam toxicity,” 125–126 Ambulatory health care, 530 Ambulatory surgery, 81, 457 America’s Health Insurance Plans (AHIP),
18, 478, 482, 498t, 521 American Academy of Allergy, Asthma, and
Immunology (AAAAI), 155, 156 American Academy of Audiology, 102 American Academy of Biological Dentistry,
125 American Academy of Dermatology, 380,
383, 390, 396 American Academy of Environmental
Medicine, 158 American Academy of Family Physicians,
28, 28t American Academy of Ophthalmology, 104,
423 American Academy of Otolaryngic Allergy,
158 American Academy of Pediatrics, 28t, 54,
78, 82, 101, 102, 115t, 119, 183–184, 278, 280, 414, 426
American Academy of Periodontology, 116 American Advertising Federation, 62 American Association for Accreditation for
Ambulatory Surgery Facilities, 457 American Association for Anti-Aging
Medicine, 450
American Association for Health Freedom, 158
American Association for Marriage and Family Therapy (AAMFT), 92
American Association of Colleges of Pharmacy, 351
American Association of Drugless Practitioners, 226
American Association of Endodontists, 120 American Association of Nutritional
Consultants (AANC), 226 American Association of Professional
Hypnotherapists, 92 American Association of Retired Persons;
see AARP American Association of Sexuality
Educators, Counselors, and Therapists (AASECT), 92
American Board of Anti-Aging Health Professionals, 450
American Board of Facial Plastic and Reconstructive Surgery, 393
American Board of Genetic Counseling, 411
American Board of Medical Genetics, 411 American Board of Medical Specialties, 50,
67, 72, 393 American Board of Opticianry/National
Contact Lens Examiners, 422 American Board of Physician Nutrition
Specialists, 192 American Board of Psychiatry and
Neurology, 90, 97 American Botanical Council, 228 American Cancer Society, 28t, 30, 77, 78,
151, 225, 289, 330, 331, 333, 335, 339, 342, 345, 346, 391, 444, 519
American Cancer Society, cancer detection recommendations, 77, 78
American Chiropractic Association (ACA), 166, 169, 172
American College Health Association, 455 American College of Advancement in
Medicine (ACAM), 24, 158 American College of Cardiology, 324 American College of Forensic Examiners,
92 American College of Gastroenterology,
363 American College of Health Science, 242 American College of Medical Toxicologists,
157 American College of Nurse-Midwives, 70 American College of Physicians Clinical
Efficacy Project, 18 American College of Sports Medicine, 264,
270t, 283, 320 American College of Surgeons, 80 American Council on Exercise, 270t, 434 American Council on Science and Health,
8, 28t, 43, 57, 191, 292, 520–521 evaluation of nutrition articles, 24 American Dental Association (ADA), 30,
49, 112, 115t, 116, 120, 121, 193, 454, 491
Council on Dental Therapeutics, 117, 119 Council on Scientific Affairs, 117, 123 Seal of Acceptance, 117 American Dietetic Association, 184, 185,
192, 279 American Endodontic Society, 120 American Health Care Association, 462 American Heart Association, 173, 264, 289,
306, 311, 314, 317, 319, 322, 324, 519–520
American Holistic Medical Association (AHMA), 158
American Holistic Nurses Association, 158 American Holistic Veterinary Medical
Association, 158 American Hospital Association, 51, 67, 454,
459, 498t American Lung Association, 289 American Medical Association (AMA), 28t,
42, 66, 67, 72, 85, 191, 438, 440, 445, 454, 483, 498t, 506, 521
and advance directives, 438, 440 and advertising by physicians, 49 Committee on Allied Health Education
and Accreditation, 71t Council on Ethical and Judicial Affairs,
73, 88, 440, 493 Council on Scientific Affairs, 18, 437 and health-care reform, 500 American Natural Hygiene Society, 145 American Nurses Association, 69, 91 American Nurses Credentialing Center
(ANCC), 69 American Optometric Association, 423, 425 American Osteopathic Association, 69 American Pharmacists Association, 352 American Podiatric Medical Association, 69 American Psychiatric Association, 101,
104, 108 American Psychological Association, 103, 105 American Psychotherapy Association, 92 American Running Association, 274 American Society for Nutrition, 191t, 192 American Society of Plastic Surgeons, 380,
393, 394t, 396 American Speech-Language-Hearing
Association, 429 American Telemedicine Association, 26 American Urological Association, 398–399 AmeriScan, 50 Amino acids, 176, 203, 530 as “growth hormone releasers,” 282 L-tryptophan, 225 supplements, unsubstantiated use, 203,
282–283 Amniocentesis, 411, 412t Amniotic fluid, 382t Amphetamines, 243 Amygdalin; see Laetrile Anabolic steroids, 281–282 Anabolism, 530 Anaerobic exercise, 262, 530 Analgesics, 530 acetaminophen; see Acetaminophen adverse effects, 361, 362t, 363
Index 543
aspirin; see Aspirin combinations, 361 comparison of, 362t costs, 363 external, 360–361, 530 for menstrual distress, 403 ibuprofen; see Ibuprofen internal, 361–363, 362t, 530 ketoprofen, 362–363, 362t naproxen, 362–363, 362t and toothache, 119 Anaphylaxis, 295, 296, 361, 530 Androgenic steroid, 530 Anderson, Dr. Terence W., 204 Androstenedione, 283–284 Anecdotal evidence, 15, 19, 23, 41, 55–56,
61, 197t, 215t, 223, 530 Anemia aplastic, 392, 530 iron-deficiency, 55, 372 pernicious, 72 Anencephaly, 445 Anesthesia, 530 Anesthesia, dental, 123, 127 Angell, Dr. Marcia, 131, 487 Angina pectoris, 16, 307, 319, 322, 325,
355, 364 Angiography, 324 Angioplasty, 325–326, 530 Animal magnetism, 94 Anorex, 251 Anorexia, 530 Anorexia nervosa, 238, 530 Antacids, 187, 361, 363, 364, 530 Anthroposophical medicine, 139, 530 Anti-aging claims for hormone products, 449–450 for skin products, 382–383 nutrition-related, 449 Antianxiety drugs, 95 Antibodies, 530 Antidepressants, 95, 97, 98, 106, 156, 214t,
297, 448 Prozac, 95, 106, 354t, 404 Antigen, 295, 530 Anti-hemorrhoidal products, 368 Antihistamines, 295–296, 355, 360, 367,
371, 372, 374, 403, 530 Antimanic agents, 95 Antimicrobials, 364–365, 530 Antineoplastons, 339–340 Antioxidants, 22, 202–203, 451, 530 Antiperspirants, 384 Antipruritic, 530 Antipsychotic drugs, 95 Antipyretic drugs, 366, 530 Anti-Quackery Ring, 521 Anxiety attack, 95 “Aphrodisiacs,” 461, 530 Aplastic anemia, 392, 530 Apocrine glands, 384 Apolipoprotein A1, 307 Applied kinesiology, 104, 105, 172, 220,
224–225, 531, 536
Aptitude tests, 106 Aromatherapy, 147 Arrhythmia, 531 Arteriosclerosis, 531 Arthritis, 296–297 and vulnerability to quackery, 36 Arthroscopy, 82, 531 Artificial sweeteners, 247–248 Asbestos, and cancer, 331 Ascorbic acid; see Vitamin C Aseptic, 531 Aslan, Dr. Anna, 449 Aspartame, 102, 247 Aspirin, 214, 361–362, 362t, 366 adverse effects, 76, 216, 295, 296, 355,
361–362, 362t and cardiovascular disease, 17, 293t, 317,
318, 361 enteric-coated, 362 and heart attacks, 322 and pregnancy, 361 and toothache, 119 Assignment of benefits, 469t, 483 Assisted living, 461, 531 Association for Addiction Professionals
(NAADAC), 92 Association for Science in Autism
Treatment, 102 Association of American Medical Colleges,
66 Association of Chiropractic Colleges
(ACC), 168 Association of National Advertisers, 62 Asthma, bronchial, 96, 101, 291, 295, 296,
361, 430 Astigmatism, 367, 421, 426, 531 Astrology, 26, 107, 151–152 Astro-Trimmer, 249 Asymptomatic, definition, 531 Atheromas, 306–307 Atherosclerosis, 531 progression, 306–307 regression, 314–315 Athlete’s foot, 390 Atkins, Dr. Robert, 20, 218, 241 Atkins Diet, 241–242 Attachment therapy, 104 Attention deficit disorder, 101 Audiologists, 71t Audiometry, 428 Auditing, in Dianetics, 105–106 Auditory integration training, 102 Aura, 148 Auriculotherapy, 125, 141 Autism, 531 autism spectrum disorder, 531 questionable treatments, 102–104 Autointoxication theory, 136, 369, 531,
532 Autonomic nervous system, 531 Autopsy, 445 Availability cascade, 10 Avogadro’s number, 138 Ayurvedic medicine, 153–154, 531
B Baby bottle tooth decay, 114 “Baby K,” 445 Bach remedies, 99 Back pain, and chiropractors, 170 Bad breath, 118 Baer, Katie, 453 Balance billing, 531 Balance training, 267 Balanced diet, 531 “Balancing body chemistry,” 41t, 124 Balch, Dr. James and Phyllis A., 222–223 Baldness, 388–389 Bandwagon effect, 10 Baratz, Dr. Robert S., iv Bariatric surgery, 248 Barnes, Dr. Carl, 342 Barnum, P.T., 6 Barnum effect, 152 Barrett, Donald W., 516–517 Barrett, Dr. Lisa Feldman, 17 Barrett, Dr. Stephen, iii, 5, 20, 22, 24, 28,
38, 40, 41, 54, 146, 159, 163, 177, 197, 202, 203, 206, 207–208, 223, 224, 226, 228, 252, 255, 302, 383, 398, 424, 446, 503, 514, 520, 521
investigations by, 61, 220, 224, 300, 507
Basal cell carcinoma, 391 Bassler, Dr. Thomas, 261 Bastyr University, 144 Bates method of eye exercise, 426 Battle Creek Sanitarium, 217, 369 Bausell, Dr. R. Barker, 159 Beard, H.H., 343 Beard Anthrone Test, 343 Bee pollen, 209t, 283 Begoun, Paula, 379, 382, 383, 386, 388 Behavior modification and emotional problems, 93 and weight control, 255–256 Benecol, 319 Benzene, and cancer, 331 Benzocaine, 244, 367 Benzoyl peroxide, 385 Berard, Guy, 102 Bergman, Dr. Thomas F., 165 Berkeley Premium Pharmaceuticals, 416 Best, A.M., 478 Beta-carotene, 202–203, 318, 392, 538 Better Business Bureau, 87, 391, 416, 447,
463, 522; see also Council of Better Business Bureaus
Beyerstein, Dr. Barry, 103 BHT, 450 Bianchini, Magaly, 37 Bias cognitive, 10 statistical, 16 Bicycle helmets, 271 Bicycles, 271 Bieber, Justin, 385 Bigelow, Charles, 357 Bile, 531
Index544
Bill of Rights, 538 consumer, vii, 504, 532 hospital, 459 managed care, 475 nursing home, 463 Bioavailability, 531 Biochemical individuality, 182 Bioequivalence (of drugs), 351, 354, 531 Bioesthetic dentistry, 121 Biofeedback, 93, 531 questionable gadgets, 99 Bioflavonoids, 198, 209t, 531 Biologic drug product, 531 Biological age testing, 450 Biological Homeopathic Industries, 140 Biomagnetic imaging, 80 Biomarkers, 536 Biophosphonates, 415 Biophotonic scanner, 203 Biopsy, 331, 531 Biorhythms, 21, 531 Biotechnology, definition, 531 Biotin, 201t, 389 Bipolar illness, 531 Birth control; see Contraception Birthing options, 413–414 Birthright USA, 410 Bismuth subsalicylate, 368, 373t Blackburn, Dr. George, 233, 241, 248 Blackstrap molasses, 209t Blood chemistry tests, 76 Blood count, complete, 76 Blood pressure high; see High blood pressure measurement, 320 and sodium intake, 187, 190t, 321 Blood sugar tests, 76, 154, 298 Blood tests, common, 75–76 Bloussant, 398 Board-certified specialist, 531 Board-eligible, 67, 531 Body mass index (BMI), 234, 235, 236t,
248, 531 Body odor, 381 Body piercing, 390 “Body types,” and ayurveda, 136, 153 of Dr. Abravanel, 243 Body wrapping, 59, 248, 249, 252 Bodybuilding, questionable products for;
see “Ergogenic aids” Bodywork, 531 Bonding, dental, 129 Bone density, 415 Bone meal, 209t Bone scan, 531 Bonnano, Dr. George A., 448 Boron, 209t Botox injections, 123, 394t, 395 Bottled water, 368, 431 Bouts, Dr. Bruce, 353 Bovine albumin, 382t Bovine somatotropin (BST), 511 Brain wave synchronizers, 6, 99 Bran, 177, 370t, 531
Bran, oat, 178, 312, 313, 315 Brandt, Joanna, 339 Brant, Freddie, 83 Braswell, A. Glenn, 59–60, 389 Breast developers, 58, 398 Breast implants, 394t, 397 Breast self-examination, 77 Breastfeeding, 180t, 412t, 414 Brewer’s yeast, 209t Brigden, Dr. Malcolm, 335 British General Medical Council, 19 Brody, Jane, 238 Brown, Helene, 329 Brown, Koby, 386 Bulimia, 114, 238, 239t Bulk producers, 245 Burton, Dr. Lawrence, 337 Burzynski, Dr. Stanislaw R., 339–340
C C.P. Direct, 398 CABG; see Coronary bypass surgery Cadaver, 531 Caffeinated alcoholic beverages (CABs),
289 Caffeine, 299, 371, 371t and insomnia, 96, 372 Caisse, Rene M., 338 Cal-Ban 3000, 251 Calcium, 186, 187t and osteoporosis, 186, 190t, 206, 293t,
415 Calcium propionate, 510 Calculus, dental, 116, 121, 127, 289, 531 California Evidence-Based Clearinghouse
for Child Welfare (CEBC), 97 California Health Care Foundation, 303 California Medical Association, 35–36 Callahan, Dr. Roger J., 105 Callus remedies, 390 Calorie(s) definition of, 531 inaccurate food labeling, 247 and weight loss, 236, 236t, 237t “CAM” movement, 131–162; see also
“Complementary and alternative medicine” (“CAM”)
Cameron, Dr. Ewan, 204 Camphor, 361, 366, 367 Canavan’s disease, 411 CanCell, 339 Cancer, 329–348 and alcohol use, 119, 331, 333 and antioxidants, 202–203 avoidable causes, 330–331 and birth control pills, 408, 409 breast, 77 and cigarette smoking, 409 corrosive agents, 337 detection, 77–78 diagnosis, 331–332 diagnostic tests, worthless, 343 and diet, 190t, 333–334 incidence, 330 information sources, 345–346
insurance coverage for, 475 mammography, 83 occult blood test, 78 Pap test, 76, 77 and “positive attitudes,” 103, 341–342 and power lines, 331 prevention, 331, 334–335 prognosis, 332 prostate, 77 prostate-specific antigen (PSA) test, 77 questionable methods, 335–344 antineoplastons, 339–340 CanCell, 339 devices, 341 diets and dietary supplements,
338–339 Essiac, 338 fiber-containing pills, 333 fresh cell therapy, 341 Gerson diet, 338–339 grape cure, 338 Greek cancer cure, 341 Hoxsey treatment, 336 hydrazine sulfate, 339 hyperoxygenation therapies, 339 immuno-augmentative therapy (IAT),
337, 342 insulin potentiation therapy (IPT), 341 Iscador, 339 Krebiozen, 336 Laetrile; see Laetrile Livingston-Wheeler treatment, 341 metabolic therapy, 343–344, 536 Mucorhicin, 337 pau d’arco tea, 338 PC-SPES, 340 promotion of, 22, 334–335, 344–345 psychologic approaches, 341–343 Revici Cancer Control, 340 714X, 340 shark cartilage, 337, 338 vitamin C, 204 questionable supplements for, 333–334 self-examination for, 77 skin, 330, 331, 337, 382, 386, 391, 392,
393 smokeless products and, 288 spontaneous remission, 332 testicular, 77 treatment, 332–333, 345–346 clinical trials, 333 evidence-based methods, 332–333 guidelines, 345–346 new methods, standards for
investigation of, 335–336 tumor registries, 333 warning signals, 330 Cancer Control Society, 344 Cancer Letter, 340 Cancer Treatment Centers of America, 56t,
345 Candidiasis, 405 “Candidiasis hypersensitivity,” 36, 156, 531 Canter, Dr. Peter, 131 Canthaxanthin, 392
Index 545
Capitation, 469t, 475, 482, 490, 492, 531 Caplan, Dr. Arthur, 437 Caplet, 531 Caplinger, Gregory Earl, 35 Capsule endoscopy, 79 Carbohydrate loading, 279 Carbohydrates, 177 complex, 60, 177, 311, 312, 315, 403,
532 fermentable, 114, 534 food sources, 178t simple, 177 Carbon monoxide detectors, 291, 496 Carcinogenic, definition, 531 Carcinoma, 531 Carcinoma, in situ, 531 Cardiac catheterization, 324 Cardiorespiratory efficiency, 263, 531 Cardiovascular disease, 305–328 advice to consumers, 325 and aspirin, 17, 293t, 317, 318, 361 and cholesterol levels; see Cholesterol and coffee consumption, 307 coronary heart disease, 306–307, 306t,
532 diagnostic tests, 322–324 and diet, 189t, 311–315, 311t heart attacks, 322 high blood pressure; see High blood
pressure and homocysteine levels, 307, 535 and hormone replacement therapy,
415–416 prevalence, 306, 306t questionable preventive methods,
318–320 rehabilitation programs, 326 risk factors, 306–309, 308t, 321 stroke, 306t, 321 surgery for, 324–326 Caridex, 120 Caries, 531; see Tooth decay Caring Connections, 441 Carnegie Foundation, 67 Carob, 209t Carotene, 531 Cartilage Consultants, 337 Cat’s claw, 214t Catabolism, 531 “Catalyst-altered water,” 209t Cataracts, 421, 426, 531 Caveat emptor doctrine, 8, 46, 531 Caveat vendor doctrine, 8, 531 Cavitational osteopathosis, 125 CCRC, 531; see Continuing care retirement
communities CDC; see U.S. Centers for Disease Control
and Prevention Cease and desist orders, 516, 532 Cell salts, 140 Cellulite, 57, 59, 248–249, 383, 532 Cellulose, 177, 178, 370t, 532 Cementum, 117 Center for Health Economics Research, 488 Center for Practical Bioethics, 441
Center for Science in the Public Interest (CSPI), 520
Center for the Study of Services, 478 Centers for Medicare & Medicaid Services
(CMS), 480, 488, 517 Central Coast Nutritionals, 251 Certification Board of Nutrition Specialists,
192 Certified milk, 212t Certified Nutrition Consultant (CNC), 222,
226 Certified nutrition specialist (CNS), 192 Cervical cap, 406t, 408 Cervix, 532 Cesarean delivery, 414 Cetuximab, 346 Chakras, 532 Chamlee, C.R., 335 CHAMPUS, 101, 532 CHAMPVA, 481 Chelated minerals, 209–210t Chelation therapy, 36, 102, 136–137,
156–157, 325 Chemosurgery, 532 “Chemotherapeutic revolution,” 507 Chemotherapy, 332–333 Cheng, Thomas F., 251 Chi, 141 Chia seed, 245 Chicken soup, 14 Child psychiatrists, 90 CHILD, Inc., 150 Childbirth options, 413–414 Children’s Health Insurance Program
(CHIP), 481 Chinese medicine, 141–143, 532 Chiropodists; see Podiatrists Chiropractors, 163–174, 532 advertising, 50, 51, 165, 169, 171, 172 avoiding trouble with, 172 boycott attempt by, 23 and children, 166, 167, 170 discount plans, 171 education, 168–169 historical perspective, 164 and holistic centers, 136 and naturopathy, 144 and nutrition, 172, 224–225 opposition to immunization, 172 organizations, 168 philosophy, 165–168 practice-building techniques, 160,
171–172 “preventative maintenance” by, 131, 171 problems for consumers, 171–173 research findings, 169–170 scope, 163, 165, 168, 170–171 and spinal ultrasound, 80 straights vs. mixers, 165 and “subluxations,”64, 165–168, 171,
172 undercover investigations of, 167 x-ray overuse, 172 Chitosan, 210t, 245 Chlorhexidine, 118–119
Chlorine filter, 302t Chlorophyll, 210t Cho Lo Tea, 318 Cholecystokinin (CCK), 246 Cholesterol, 177, 308, 532; see also Lipids,
blood and cancer risk, 311 and CHD death rate, 309 dietary, 311, 311t and food advertising, 315 guidelines, 309–310, 310t HDL; see HDL home testing, 311 LDL; see LDL NCEP classification, 310t and obesity, 235, 307 scam, 318 testing, 76, 309–311 Choline, 210t Chopra, Dr. Deepak, 25–26, 135, 154 Chorionic villus sampling (CVS), 411 Christian Brothers, 513 Christian Science, 149–150 Christian Science Sentinel, 150 Chromium picolinate, 191, 210t, 246,
283 Chromosome defects, 411 Chronic condition, definition, 532 Chronic fatigue syndrome, 156, 532 Chronobiology, 21 Cider vinegar, 210t Cigarette advertising, 4, 53–54 Cigarette smoking, 4, 15, 46, 53, 288–290,
307, 308t, 320, 321, 323, 325, 331, 364, 382, 415
Circumcision, 82 Citizen’s Commission on Human Rights,
106 Citizens for Health, 228 Citizens for Responsible Care and Research
(CIRCARE), 521 Citrinin, 319 Civil procedure, definition, 532 Clark, Hulda, 338 Clayton College of Natural Health, 226 Clinical, definition, 532 Clinical ecology, 154, 532 Clinical mental health counselors, 91 Clinical trials, 15, 137, 345, 512, 532 of cancer drugs, 333 Clinton, Bill, 59 Clinton, Hillary Rodham, 467 Closed-panel HMO, 532 Clostridium difficile, 365 Clove oil, 119 Coagulate, definition, 532 Cochrane Collaboration, 18 Codeine, 366, 511 Coenzyme Q10, 283, 319 Coffee enemas, 338, 339, 341, 343, 537 Cognitive bias, 10 Cognitive therapy, 93 Cohen, Paul, 467 Co-insurance, 469t, 470, 532 Cold-pressed oils, 210t
Index546
Colds remedies, 355, 365–367 symptoms, 366t Colitis, pseudomembranous, 365 Collagen injections, 394t, 395 Colloidal silver, 210t Colonic irrigation, 137, 532 Colonoscope, 78, 532 Colonoscopy 77, 78, 293t, 331, 497 ColoPure, 251 Comedos, 384, 385, 532 Commission E Report, 215t Committee for Freedom of Choice in
Medicine (CFCM), 43 Committee for Skeptical Inquiry (CSI), 152,
520 Commonwealth Fund, 488–489 Community reinforcement approach, 97 Compassion & Choices, 441 “Complementary and alternative medicine”
(“CAM”), 131–162; see also Quackery and frauds
acupressure, 105, 141, 220, 302t, 530 acupuncture; see Acupuncture anthroposophical medicine, 139, 530 applied kinesiology; see Applied
kinesiology astrology, 26, 107, 151–152 attitudes toward research, 157 ayurvedic medicine, 153–154 biorhythms, 21, 531 cancer and; see Cancer treatment,
questionable chelation therapy, 36, 102, 136–137,
156–157, 325 chiropractic, 162–164; see also
Chiropractors classification, 134–136 common themes, 135–137 definitions, 131, 132, 532 dental; see Dentistry, dubious and drug compounding, 353 fad diagnoses, 36, 72, 125–126, 154–156 faith healing; see Psychic healing herbal therapy; see Herbs and herbal
remedies “holistic medicine,” 136, 535 homeopathy; see Homeopathy Institute of Medicine report, 159 iridology, 145–146, 536 lack of supporting data, 21, 137 Maharishi Ayur-Ved, 153–154 misleading publicity about, 134 natural hygiene, 145, 242, 537 naturopathy, 143–146 orthomolecular therapy, 100–102, 537 popularity, 134, 216 President’s Commission on, 159 prevalence of use, 134 psychic healing; see Psychic healing questions for evaluating, 136 reasons for seeking, 134 reflexology, 146, 539 research grants from NIH, 157, 158–159 supportive organizations, 158
therapeutic touch, 147 transcendental meditation (TM), 152–154 unscientific medical practices, 154-158 victims of; see Quackery, victims of visual training, 104, 426, 540 vulnerability to; see Quackery,
vulnerability to yoga, 134, 268, 532 “Complementary medicine,” definition,
132, 532 Complete protein, 532 Complex carbohydrates, 60, 177, 311, 312,
315, 403, 532 Compounding (of drugs), 353, 532 Comprehensive Nutritional Profile, 220 Computerized axial tomography (CT or
CAT), 79 Computerized tests for “nutrient
deficiency,” 124–125, 221 Concierge medicine, 476–477 Conditioners (for hair), 381, 386, 532 Condoms, 407, 406t Confidentiality, definition, 532 Confirmation bias, 19 Confirmatory test, 532 Congenital, definition, 532 Conjugated linoleic acid (CLA), 245 Conrad, Ruth, 37 Conscious sedation, 123 Consent decree (or order), 532 Consolidated Omnibus Budget
Reconciliation Act (1986, 1990), 455, 474
Conspiracy claims by quacks, 20, 34, 42–43, 227
Constipation, 178, 369–370 Consultations, 85, 300 Consumer Bill of Rights, 504, 532 Consumer-directed expense accounts, 476 Consumer health, 1 “I.Q. test,” 2 definition of, 2, 532 questions pertaining to, 3, 11 Consumer Health Digest, 30, 520 Consumer health profile, 11 Consumer Health Sourcebook Web site, x,
12, 504 Consumer Healthcare Products Association,
389 Consumer Information Center, 517 Consumer Justice Center, 432 Consumer Product Safety Commission,
508, 517 Consumer protection, 502–524; see also
Enforcement actions; Intelligent health consumer; Physicians, effective communication with
analysis of forces, 9–11, 9t basic principles, 43–44, 504, 515 consumer action, 522–523, 522t federal agencies, 517–518, 526; see also
Federal Trade Commission; Food and Drug Administration; U.S. Postal Service
laws; see under Laws
need for, 8–10 nongovernmental organizations,
519–521, 526–528 state and local agencies, 538 Consumer Reports, 24, 98, 118, 126, 141,
156, 172, 214t, 216, 223, 247, 256, 259, 291, 303, 314, 320, 355, 363, 364, 372, 375, 380, 381, 382t, 383, 384, 387, 391, 392, 401, 402, 407, 415, 423–424, 429, 430, 447, 453, 459, 460, 462, 464, 478, 507, 520
Consumer Reports Best Buy Drugs, 374t Consumer Reports on Health, 14, 25t, 28t,
30, 52–53, 255, 256, 259, 363, 369, 383, 426, 438, 460, 520
ConsumerLab.com, 215t, 216, 398, 521 Consumers Research, 127 Consumers Union, 75, 118, 158, 243, 364,
366, 371, 452, 475, 490, 500, 520 Contact dermatitis, 295, 361, 373t, 390 Contact lenses, 424, 425t Continuing care retirement communities,
464, 465t Continuing medical education (CME), 532 Continuous passive motion (CPM) tables,
275 Contour reshaping devices, 396 Contraception, 406–410, 406t, 532 barrier methods, 406t , 407, 408 cervical cap, 406t, 408 condom, female, 406t, 407 condom, male, 406t, 407 diaphragm, 406t, 407–408 emergency, 409 fertility awareness (rhythm) methods,
406t hormonal methods, 406t, 408–409 intrauterine devices (IUD), 406t, 408 major types, 406, 406t spermicidal products, 406t, 408 surgical sterilization, 406t, 409–410 vaginal sponge, 406t, 408 withdrawal, 406t Contracture, 532 Contraindication, definition, 532 Conversion (of insurance policy), 469t, 471 Coordination of benefits, 469t, 471, 474, 532 Cooper Institute, 270t Co-Payment, 469t COPD, 532 Copeland, Caroline, 37–39 Copeland, Sen. Royal, 138 Cord blood banking, 414 Cornea, 421, 421, 426, 532 Corns, 390 Coronary, definition, 532 Coronary bypass surgery, 325 Corrective advertising, 516 Corrective lenses, definition, 532 CortiSlim, 251 Cosmetic surgery, 393–397, 394t breast enlargement, 394t, 397 fees, 394t liposuction, 249, 394t physician selection for, 393, 395
Index 547
Cosmetics for aging skin and wrinkles, 382–383 camouflage, 393 categories, 380 definition, 380, 532 fade creams, 384 healthy attitude toward, 383 marketing of, 46 moisturizers, 379, 381–382, 383, 387 questionable claims, 382–383 questionable ingredients, 382t regulation, 380–383, 513 shampoos, 386–387 soaps and cleansers, 381 Cost-effective, definition, 532 Cough and cold remedies, 360, 365–367 Council for Agricultural Science and
Technology (CAST), 191 Council for Responsible Nutrition, 201t,
221, 228 Council of Better Business Bureaus, 62, 521 National Advertising Division, 62–63,
345, 521, 522t Council of Medical Specialty Societies, 67 Council on Chiropractic Education (CCE),
168 Council on Naturopathic Medical
Education, 144 Council on Recognition of Postsecondary
Accreditation (CORPA), 21, 143, 530 Council on Social Work Education, 91 Counterirritants, 360–361, 368, 532 CPT codes, 483, 485t, 532 Craig, Gary, 105 Cranial therapy, 125, 147 Creatine, 282 Credentials, dubious, 84, 92, 100, 225–227 Crelin, Dr. Edmund, 167–168 Cremation, 446 Criminal Fine Enhancement Act (1984),
513 Crook, Dr. William J., 156 Crown, of tooth, 532 Cruzan, Nancy, 441 Cryonics, 451 Cryosurgery, 386, 532 CT scans, 79, 532 unwarranted use, 80 Cuforhedake Brane-Fude, 506 Cult, definition, 533 Curanderas, 133 Curare, 214 Cure for All Cancers, 338 Current Procedural Terminology, 483, 532 Custodial care, 462, 465t, 481 Cystoscope, 533
D Daily Reference Values (DRVs), 188, 533 Daily Values (DVs), 187t, 188, 509 Dandruff, 387 Dark-field microscopy, 220 DASH diet, 321 Data Bank, 519 Database, definition, 533
Davies, Dr. Nicholas, 487 Davis, Adelle, 20, 218 Davis, Dr. Edward H., 15 Day, Dr. Lorraine, 344–345, 521 Deafness, 427–428, 428t Death body disposition, 445–447 coping with, 437–452 death certificates, 445 naturalness of dying, 440 Decibels, 428, 428t Decongestants, 244, 360, 365–366, 367,
373t, 533 Deductible, 533 DEET, 91 Defensive medicine, 84, 533 Defibrillator, 533 Deficiency diseases, 179, 181 Dehydroepiandrosterone; see DHEA Delaney Clause, 505, 509 Delusion, 533 Dementia, 533 Dental assistants, 112–113 Dental care, 111–130, 289 advertisements for, 49, 50, 127 allied personnel, 112–113 anesthesia, 112, 123 bonding of teeth, 120 dentifrices, 116, 117, 533 dentists, selection of, 126–128 dentures, 121 denturists, 113, 121 disclosing solutions, 116 endodontics, 112, 120, 124 fees, 127, 490, 491t floss and toothpicks, 118 fluoridation; see Fluoridation implants, 131 insurance for, 482–483 irrigators, 118 laser drilling, 121 mouthwashes, 118–119 orthodontics, 112, 120 pain relievers, 119 periodontal disease, 115–116, 122, 289 plastic surgery, 123 products, 117–119 quackery, 124–126 questionable, 122–126, 128 restorations, 119–120 sealants, 114 self-care, 116–119 specialties, 112 toothbrushes, 116, 118 x-ray procedures, 121–122 Dental hygienists, 113 Dental laboratory technicians, 113 Denturists, 113, 121, 533 Deodorants genital, 404 underarm, 384 Dependence, physical, 538 Depilatories, 387 Depo-Provera, 406t, 409 Depression, 90
Derbyshire, Dr. Robert C., 83 Derelian, Dr. Doris, 194 Dermabrasion, 386, 393, 394t, 533 Dermatitis, definition, 533 Dermatron, 139 Desiccated liver, 210t Desiccated thyroid, 210t Desirable weights, 235, 235t “Detergent foods” myth, 116 “Detoxification,” 6, 41t, 102, 136–137,
144–145, 197t, 217, 341, 343, 369, 432, 434
Devices, health, 419–436 acupuncture needles, 143 adverse reports, 421 blood pressure kits; see
Sphygmomanometers breast developers, 58, 398 for cancer, 341 classification by FDA, 420–421 detoxification devices, 432, 434 E-meter, 105–106 ear candles, 435 Electric Ear, 102 electric muscle/nerve stimulators, 60, 276 electroacupuncture devices, 139, 142 EMF protectors, 434–435 exercise and fitness; see under Exercise
equipment hearing aids, 427–429 humidifiers, 439 legal definition, 420 magnetic products, 432 performance-enhancing products, 424 personal emergency response systems,
430, 465t quack, 6–7, 99, 139, 341, 431–435 questionable self-help, 302t regulation, 420–421, 512–513 spinal decompression machines, 431 TENS, 540 ultrasound; see Ultrasound devices vaporizers, 430 vision products and services, 421–427 water purifiers, 430–431 weight control gadgets, 249–250 DeVita, Dr. Vincent, 333 DeWys, Dr. William, 204 DEXA scan, 41 DHEA, 210t, 246, 416, 449–450 Diabetes, 298, 413 Dial-a-Dietitian, 193 Diamond, Harvey and Marilyn, 145, 242 Dianetics, 105–106 Diaphragm, 406t, 407–408 Diarrhea remedies, 368 Diathermy, 533 Diet; see also Dietary guidelines assessment, 312 and behavior, 101–102 and cancer, 190t, 333–334 candies, 250 and cardiovascular disease, 189t,
311–315, 311t cholesterol-lowering, 309–315
Index548
Diet—cont’d. computer analysis of, 124–125, 221, 312 and constipation, 178, 369–370 and high blood pressure, 320–321 and life-extension claims, 449 Diet Center, 254 Diet teas, 244, 318 Dietary guidelines Dietary Guidelines for Americans,
179–181, 180t, 533 for cancer prevention, 333 for infants and toddlers, 183–184 for vegetarians, 185 Dietary Reference Intakes (DRIs), 179,
181–182, 533 Dietary Supplement Health and Education
Act (DSHEA), 43, 55, 63, 198, 228, 244, 507, 509, 534
Dietary supplements, 197–206; see also Vitamin(s), supplements
amino acid products, 203 antioxidants, 22, 202–203, 450, 530 appropriate use, 206 consumer confidence in, 199 dangers of excess dosage, 205–206 expenditures for, 198 fruit and/or vegetable “concentrates,” 62,
203, 333 inappropriateness of formulations, 199, 223 legal definition, 198 “meals in a can,” 200 misleading advertisements for, 201t multivitamin/mineral combinations, 199 “natural” vs. synthetic vitamins, 197t,
202 “nutrition insurance,” 56t, 199–200, 201t phytochemicals, 202–203, 538 promotion, 54–56, 197t, 201t, 217–221 questionable assumptions, 213 reasons for use, 196, 197 for “special needs,” 182, 200 “stress supplements,” 200, 201t, 202 Dietitians, 192 Diets; see also Weight control Atkins, 241–242 difficulty with “dieting,” 236–237, 239t fad, shortcomings of, 240 fasting, complete, 240–241 fasting, supplemented, 241 Feingold, 101–102 Fit for Life, 145, 242 Herbalife system, 250 low-calorie balanced, 254 low-carbohydrate (high-protein),
241–242 low-fat, 315 macrobiotic, 219, 338, 536 Pritikin, 315 questionable, 240–243 Therapeutic Lifestyle Changes (TLC)
diet, 311t vegetarian, 184–185 very-low-calorie, 241 Zone, 241 Digital Object Identifier (DOI) numbers, 12
Digitalis, 214 Dilate, definition, 533 Diopter, 533 DiOrio, Father Ralph, 151 Diploma mill, definition, 533 Diplomate, definition, 533 Disability insurance, 484, 486 Disorientation, 533 Diuretics, 240, 243, 321, 403, 533 Diverticulitis, 76, 178 DNA (deoxyribonucleic acid), 212t, 411 DNR order, 440, 533 Do Not Call Registry, 62 Doctors: see Physicians Doctrine of signatures, 211, 533 Dodes, Dr. John E., 7, 111, 122, 123, 124,
125, 127 Dolomite, 210t Doman-Delacato treatment, 102 Don’t Go to the Cosmetics Counter Without
Me, 382 Donsbach University, 226 Donsbach, Kurt W., 226, 227 Dose-response, 533 Doshas, 153 Double-blind study, 15, 533 Doublespeak, 46 Douching, 404 Doulas, 414 Down syndrome, 412 Doyle, Rodger P., 15 Dream Away, 246 Drenick, Dr. Ernest, 245 DRGs (diagnosis-related groups), 493, 533 DRIs, 179, 181–182, 533 Drown, Ruth B., 43 Drug abuse programs, 96–97 Drug Facts label, 359 Drug products, 349–378 acne remedies; see Acne adulteration, 497, 512 advertising, 51–53, 359 allergies to, 295 allergy products, 295–296 analgesics; see Analgesics antacids, 187, 361, 363, 364, 530 antianxiety agents, 95 antidepressants; see Antidepressants anti-hemorrhoidals, 368 antihistamines; see Antihistamines antihypertensive, 321 antimicrobial, 364–365 antiperspirants, 384 antipsychotic, 94, 95 aspirin; see Aspirin athlete’s foot remedies, 390 cholesterol-lowering, 315–317, 316t classification of, 350–351 clinical testing of, 512 compounding, 353, 532 contraceptives; see under Contraception corn and callus remedies, 390 cost-saving strategies, 375–376 cough and cold remedies, 360, 365–367 counterfeit, 355, 358
deodorants; see Deodorants diarrhea remedies, 368 disposal guidelines, 375 estrogens; see Estrogens generic, 350, 354–355, 354t, 534 heartburn remedies, 364 for home medicine cabinet, 373, 373t homeopathic; see Homeopathy information sources, 374t imported, 358, 511–512 interactions with foods, alcohol, and
other drugs, 355 Internet pharmacy sales, 358, 376 investigational, 511 iron-containing, 372–373 labeling requirements, 354, 359, 505,
508, 511–512 laws pertaining to; see Food, Drug, and
Cosmetic (FDC) Act laxatives, 369–370, 370t legal definition of, 533 for menstrual distress, 403–404 motion sickness remedies, 372 “new”; see New drug off-label use, 537 ophthalmic, 367–368 orphan, 508 over-the-counter (OTC), 359–360, 511,
538; see also Patent medicines criticism of combination products, 360 expenditures, 359 FDA review of, 352, 360 frequency of use, 359 labeling, 359 suggestions for using, 360 switch from Rx status, 360 prescription, 350, 353, 511–512, 538 proprietary, 538 prudent use, 360, 373–375 psychopharmacologic agents, 94–95 rebound from, 539 recalls, 355 safety precautions, 375 sleep aids, 371, 372 smoking deterrents, 371–372 sore-throat products, 367 stimulants for fatigue, 371, 371t sunscreens, 391–392 tolerance to, 540 topical, 540 weight control, 243–244 Drugstore.com, 354, 376 DSHEA; see Dietary Supplement Health
and Education Act (DSHEA) Dublin, Louis, 235 Dumping, patient, 455 Durable medical equipment, 471, 489t,
492t, 498, 533 Durable power of attorney for health care,
438–440 Durovic, Dr. Steven, 336 Dyott, Thomas W., 356 Dyslexia, 104 Dysmenorrhea, 403, 533 DXA scan, 415
Index 549
E Ear candling, 435 Earl Mindell’s Vitamin Bible, 229 Eat Right 4 Your Type, 242–243 Eating disorders, 238, 240 Eccrine glands, 384 Echinacea, 214t Echo stress testing, 324 Echocardiography, 324 Economies of scale, 533 ECT; see Electroconvulsive therapy (ECT) Eddy, Mary Baker, 149 Edema, definition, 533 EDTA, 157 Education Commission for Foreign
Graduates, 67 “Effortless exerciser,” 376 Eggs, fertile, 210t Eisenberg, Dr. David, 134 Eisenhower, President Dwight D., 260 Elective procedure, definition, 533 Electric muscle/nerve stimulators, 60, 276 Electroacupuncture according to Voll
(EAV), 139 Electroacupuncture devices, 139, 341 Electrocardiogram (ECG), 76, 323 Electroconvulsive therapy (ECT), 95 opposition to, 106 Electrodermal testing, 220 Electroencephalogram (EEG), 533 Electrolysis, 337–338 Electrolytes, 179, 533 Electromagnetic field protectors, 302t,
434–435 Electron-Beam Computed Tomography
(EBCT), 324 Electronic Medical Foundation, 227, 433 Electronic record-keeping, 493–494 Electronic Retailing Association, 63, 521,
522t Electroshock therapy; see Electroconvulsive
therapy (ECT) Electrosurgery, 533 Elliptical exercisers, 271 Ellon USA, Inc., 99 Embryo, definition, 534 EMDR, 103 Emergency care, 74, 455 Emergency contraception, 409 Emergency medical identification, 74, 296,
297 Emergency medical technicians (EMTs), 71t Emergency response systems, 430, 465t Emery, C. Eugene, Jr., 151 E-Meter, 105–106 Emollients, 381, 382t Emotional Freedom Technique (EFT), 105 Emphysema, 533 Encounter groups, 100 Encyclopedia of Medical Organizations and
Agencies, 526 Encyclopedia of Natural Medicine, 144 Endermologie, 252
Endodontics, 112, 120, 124 Endometriosis, 403, 533 Endometrium, definition, 533 Endorphins, 403, 533 Endorsements insurance, 469t of products, 4, 20, 385 Endoscopy, 80, 533 Endurance exercise, 262 Enemas, 369 coffee, 338, 339, 340, 343 Energy bars, 280 Energy drinks, 280 “Energy medicine,” 147–148, 533 Enforcement actions federal; see under Federal Trade
Commission; Food and Drug Administration; U.S. Postal Service
state and local, 50, 61, 99, 126, 200, 202, 227, 244, 250, 251, 318, 340, 341, 343, 389, 396, 398, 416, 427, 433, 452, 501
English, Dr. O. Spurgeon, 95 Enrichment, 200, 208, 510, 533 Ensure, 56t, 200, 201t Entelev; see CanCell Enteric coating, 533 Environmental Health Center, 155 “Environmental illness,” 534 Environmental Nutrition newsletter, 25t Environmental Protection Agency (EPA),
207, 291, 302, 331, 391–392, 431, 505, 517
Environmental tobacco smoke, 288, 295, 296 Enzymatic Therapy, 514t Enzymes, 534 “deficiency” of, 220, 343 oral, 210t in raw foods, 213 EnZyte, 416 Eosinophilia-myalgia syndrome, 225 Ephedra-containing products, 214t,
215–216, 244 Epidemiology, 17, 534 Epinephrine; see Adrenaline Epping, Linda, 37 Epstein-Barr virus, 156 Equal; see Aspartame Erectile dysfunction, 416–417 “Ergogenic aids,” 6, 42, 46, 59t, 60, 225,
279, 282–284 Ernst, Dr. Edzard, 15, 135, 139–140, 142,
170, 173 Esselstyn, Dr. Caldwell E., Jr., 315 Essential hypertension, 320 Essential nutrients, 181, 182, 254, 534 Essiac, 338 EST; see Electroconvulsive therapy (ECT) Estimated average requirement (EAR), 181 Estrogens, 534 and contraception, 408–409 and heart disease, 415–416 Etiology, definition, 534 Euthanasia, 444–445
Euthanasia Research and Guidance Organization (ERGO), 445
Evans, Gary, 209t Evening primrose oil, 209t Evidence-based medicine, 534 “Excedrin headaches,” 53 Exclusions (insurance), 469t, 471, 482, 499 Exclusive provider organization (EPO), 476 Exercise and fitness, 259–286 and anabolic steroids, 281–282 benefits, 261–262, 288 boredom, prevention of, 264–265 calories burned during, 254t and cardiac rehabilitation, 326 and children, 278 components of fitness, 262–263 equipment and supplies, 60, 270–276,
272–273t, 278 ergogenic aids; see “Ergogenic aids” facilities, 276–278 guidelines, 263–269, 263t, 265t, 266t,
268t, 269t historical aspects, 260–261, 284 in-home, 259, 278 injuries, 268–269, 268t instructors, 269 intensity, assessment of, 266–267 and longevity, 261 martial arts training, 278 myths, 281t and nutrition, 279–280 programs, 263–269, 266t public perceptions, 260–261 reasons for, 261–264 sports medicine specialists, 270 strength training, 261, 262, 267, 274 and stress reduction, 262 stretching, 266, 266t types, 262 and vitamin needs, 200, 279 and weight control, 236, 238, 255, 254t,
279, 281t while traveling, 278–279 Exercise physiologists, 270 Exercise testing, 264, 323–324 Expectorants, 336, 366, 534 Expenditures, health care; see also Health
care, costs chiropractic care, 164 cold and cough remedies, 365 dietary supplements and herbal products,
198 OTC drugs, 359 per capita, 488, 492t personal health care, 488–490, 489t, 492t quackery, 35 skin care and image enhancement, 380 total U.S., 488, 489t weight-control products and services, 240 Extended care, 463, 534 Eyeglasses, 423–425 Eyes, professional evaluation, 423 Eyewashes and decongestants, 367
Index550
F Facelift, questionable claims, 396 Facilitated communication, 103 Facts, scientific, how determined, 14–19 Fad diagnoses, 36, 72, 125–126, 154–156 Faddism, food; see Food faddism Fade creams, 384 Fair Packaging and Labeling Act (1966),
505, 507, 508, 513, 515 Faith healing; see Psychic healing Fallopian tubes, 534 False memory syndrome, 105 False-negative tests, 534 False-positive tests, 534 Family therapy, 94 Farsightedness, 421, 422 Fast food, 186 Fasting, 136, 144, 145, 261, 284, 338 physiology, 240–241 Fat(s), 176–177; see also Cholesterol;
Lipids chemical composition, 176–177, 314 dietary guideline, 180t food sources, 178t percentage in diet, 311, 311t sterol-enriched margarines, 319 substitutes for, 248 FDA; see Food and Drug Administration
(FDA) Feder, Dr. Bernard, 85 Federal Bureau of Investigation (FBI), 25,
62, 497, 517, 522t Federal Trade Commission (FTC), 8, 9t, 25,
28t, 62, 504, 515–517, 521, 522t Business Opportunity Rule, 61 and cosmetic claims, 383 dietary supplements advertising guide,
55–57 enforcement actions, 49, 53, 54, 59–60,
61, 101, 124, 157, 218, 219–220, 225, 246, 250–252, 254, 291, 319–320, 337, 345, 386, 389, 427, 432, 434, 515–517, 521
eyeglass rule, 424 functions and responsibilities, 515 funeral rule, 446, 447 and hearing aids, 429 industry guides, 516 and infomercials, 60–61 Internet activities, 517 laws, 507, 508, 515 and personal emergency response
systems, 430 procedures and penalties for law
violations, 515–516 and professional advertising, 49 and telemarketing, 62 trade regulation rules, 516 and weight-loss advertising, 250–252,
254 Federation of American Societies for
Experimental Biology, 203 Federation of State Medical Boards, 67, 519 Fee-for-service care, 474, 477t, 490, 534
Fees consumer action regarding, 496 cosmetic surgery, 394t dental, 127, 490, 491t medical, 490, 491t mental health services, 97 RBRVS, 484 UCR, 470, 483, 485, 490, 491t at urgent care centers, 456 Feifel, Herman, 437 Fein, Dr. Rashid, 500 Feingold diet, 101–102 Felder, Dr. Louis H., 487 Ferrari, Dr. Carl, 103 Fertile eggs, 209t Fertility awareness methods, 406, 407t Fetal alcohol syndrome, 289 Fetus, definition, 534 Fiber dietary, 177–178, 534 insoluble, 178 and irritable bowel syndrome, 299 label claims permitted, 188, 190t recommended intake, 178 soluble, 178, 190t, 312–313 sources, 177–178, 312–313 supplements, 178, 319 Fibromyalgia, 298 Finasteride, 388 Finch, Dr. Stuart M., 95 Finkel, Andrew N., 386 Fish oils, 210t–211t, 239t, 314 Fit for Life Diet, 145, 242 Fitness; see Exercise and fitness Fitness Quest, Inc., 60 Fixx, Dr. Jim, 261 Flatulence, 243, 299, 364, 534 Fleiss, Dr. Wilhelm, 21 Flexible spending accounts (FSAs), 476 Flexibility, 263, 266, 266t, 534 Flexner, Dr. Abraham, 67 Florida Department of Citrus, 56t Florsheim MagneForce shoes, 432 Fluoridation, 111, 114–115, 490, 496, 534 alternatives, 115, 115t, 117 opposition to, 27, 42, 114–115, 127, 145,
197t, 205, 227, 229 Fluoride dentifrices, 115, 117 mouth rinses, 115 supplements, 115, 115t, 184 Fluorosis, 115 Folic acid, 178t, 179, 180t, 186, 187t, 191,
206, 293t, 307, 412, 412t Folk medicine, 133 Food(s); see also Diet; Diets; Food faddism;
Nutrition additives, 101, 392, 505, 509–510 adulteration, 509 advertising, 4, 54, 315 allergies, 184, 295–296 calories per gram, 531 combining, 145, 534, 537 energy, 531
energy bars, 280 enrichment, 200, 208, 510, 533 faddism; see Food faddism faddists, types of, 196t fast, 186 fortification, 177, 180t, 208, 510, 534 groups, 182 “health”; see “Health foods” irradiation, 510–511 junk, 186, 195 labeling; see Nutrition, labeling low-calorie, 189t, 246–248 major components, 175–179 misbranding, 509, 537 myths, 198 “natural,” 114, 207–208 “organic,” 206–207 pesticide levels, 207, 218 preservatives, 208, 218, 509, 510, 530 processing, 197t, 200, 201t, 208, 218 raw, 213 safety, 180t, 208 supplements; see Dietary supplements taste, factors affecting, 207 Food and Drug Administration (FDA),
504–515 and acupuncture needles, 143 and “antiaging” cosmetics, 383 and “aphrodisiacs,” 416 and aspirin advertising, 17 and bodybuilding products, 282, 284 and breast implants, 397 and cholesterol-lowering “dietary
supplements,” 319 and compounded drugs, 353 cosmetic regulation, 380–381 definition of health fraud, 34 and device regulation, 420–421, 512–513 and drug package inserts, 51, 53, 376 drug recalls, 355 and drugs, clinical testing of, 512 educational activities, 514–515 enforcement actions, 17, 61, 99, 102,
106, 120, 140, 157, 210t, 211t, 212t, 214t, 217, 218, 225, 229, 244, 250, 251, 284, 291, 319, 336, 337, 355, 339, 383, 416, 449, 510 513–514, 514t, 518
enforcement priorities, 514 and ephedra products, 244 and eyeglass safety, 523 and feminine deodorant sprays, 404 fiscal year, 534 and food additives, 509–510 and full-body CT scans, 80 and generally recognized as safe (GRAS)
list, 509 and generic drugs, 351, 354 and genetically engineered foods, 511 headquarters offices, 504 health-food–store investigation, 224 and hearing aids, 429 and homeopathic remedies, 140 and home medical test approval, 294 and irradiation, 510–511
Index 551
and “keepsake ultrasound,” 413 and Laetrile, 337 laws pertaining to; see Food, Drug, and
Cosmetic Act and low-calorie foods, 241, 246–247 “market basket” studies, 207 and meal-replacement products, 241 and mouthwashes, 118 and nutrition labeling; see Nutrition,
labeling and online drug purchases, 358, 376 and ophthalmic products, 367 and oral contraceptives, 409 OTC drug review, 352, 360, 512; see also
products listed under Drug products and phenylpropanolamine (PPA), 244 and prescription drug marketing, 51–52 procedures and penalties for law
violations, 513 and raw milk, 212t and Scientology, 105–106 and tampons, 402 and tanning booths, 392 and thalidomide, 505, 507 and thyroid drug labeling, 243 and tobacco regulation, 54 top 10 health frauds, 36 and vitamin dosage, 199 reporting to, 522 Food and Nutrition Board, Institute of
Medicine, 181 Food, Drug, and Cosmetic Act, 509–513 amendments; see under Laws, Food,
Drug, and Cosmetic Act cosmetic provisions, 380, 513 device provisions, 420–421, 512–513 drug (human) provisions, 511–512 food provisions, 509 history of, 506–507 and homeopathic remedies, 138 procedures and penalties for violations,
513–514 Food faddism, 113–114, 196–197 definition of, 196 macrobiotic diets, 219, 338, 536 promoters of questionable nutrition, 124,
217–218, 221–229 promotion of questionable nutrition,
221–229 roots of, 124, 217–218 and supplements; see also Dietary
supplements; Minerals; Vitamin(s) and tooth decay, 113–114, 124 types of faddists, 196t and weight control; see Weight control Food Guidance System, 183 Foolology, 198 FORBA Holdings, 128 Forer, Bertram, 151–152 Fortification, 177, 180t, 208, 510, 534 Foster, Peter, 318 Foundation for Economic Trends, 511 Foxglove, 214–215 Framingham Study, 261 Franklin, Benjamin, 94
Frauds; see Quackery FRAX tool, 415 Fredericks, Carlton, 218 Free radicals, 202, 450, 534 Freedom of choice”; see “Health freedom” Freedom of Information Act requests (to
FDA), 515 FreeLife International, 229 Freireich, Dr. Emil J, 335 Fresh cell therapy, 341 Fries, Dr. James F., 287, 297 Frum, David, 131 FTC; see Federal Trade Commission Functional foods, 534 Funeral Consumers Alliance (FCA), 446 Funerals, 8, 445–447
G Galileo, 20–21 Gallbladder surgery, 81-82 Gamma hydroxybutyrate (GHB), 282–283,
514t Gangrene, 534 Garcinia cambogia, 245 Garlic, 214t, 216, 318 Gastroesophageal reflux disease (GERD),
364 Gastrointestinal tract, 534 Gatekeeper, 469t Gatorade, 280 Gay, Dennis, 251 General Accounting Office; see Government
Accountability Office (GAO) General anesthesia, 70, 80, 123, 413, 534 General Nutrition Inc. (GNC), 201, 225 General practitioner, 534 Generic drugs, 350, 354–355, 354t, 534 Genes, 294, 411 Genetic engineering, 450, 534 of foods, 511 Genetic testing dubious, 295 and prenatal counseling, 411 Genital, definition, 534 Gerber Products Company, 184 Geriatric psychiatrists, 90 Geritol, 55 Germanium, 211t, 339 Gero Vita International, 59 Gerovital H3 (GH3), 449 Gerson diet, 338–339 Gerson, Dr. Max, 338 Gestational diabetes, 413 Getting Well Again, 342 Gingivitis, 116, 119, 534 Ginkgo biloba, 214t Ginseng, 214t, 283 GlanDiet, 243 “Glandular” extracts, 48, 210t, 211t Glaucoma, 422, 423, 426, 534 Glucomannan, 245 Glucosamine, 211t Glucose, 154, 177, 240, 241, 279, 281, 534 and diabetes, 298 Glucose tolerance test, 154
Glycogen, 177, 279, 281t, 534 Glyoxylide, 334 Goldenseal, 214t Gonzalez, Dr. Nicholas, 343 Goodstein, Dr. David, 19 Google, 27 Gorayeb, Ronald A., 251 Gorski, Dr. Timothy N., 414 Gotu kola, 218 Gout, 297 Government Accountability Office (GAO),
224, 421, 450, 463, 517 Grace period, 469t Graham, Sylvester, 217 Grain (weight), definition, 534 Gramazon.com, 487 Granfalloons, 37 Granola, 114, 211t, 534 Grant, W.V., 149 Granula, 217 Grape cure for cancer, 338 Grape Nuts, 217 Grapefruit-drug interactions, 355 GRAS list, 509 Grave liner, 446 Gravity inversion devices, 374 Greek cancer cure, 341 Green tea, 214t, 244, 334 Green, Dr. Saul, 340 Greene, Dr. Ralph, 84 Grief and mourning, 448 Gross domestic product (GDP), 488, 534 Group therapy, 94 Growth hormone, 21, 207, 281, 449 “Growth-hormone releasers,” 246, 282 Guar gum, 244, 245, 251, 312 Guarana, 211t Guggulsterone, 319 Guidelines, science-based, 10, 18 GuideStar, 526 Gum disease; see Periodontal disease Gum, sugarless, 118 Gunther, Max, 4, 22, 23 Gymnema sylvestre, 246
H H2 blockers, 364 HAART, 406 Hadacol, 357 Haemophilus influenzae type b, 78, 293t Hahnemann, Samuel, 137, 138, 530 Hair analysis, 124, 172, 219–220, 224 care, 386–389 conditioners, 381, 386, 532 dyes, 386, 513 excess, removal of, 387–388 hair-growth frauds, 389 loss of, 388–389 relaxers, 388 replacement surgery, 389 transplants, 534 Halitosis, 118 Hall, Dr. Harriet A., iv, 59, 216 Hammond, Dr. John, 499
Index552
Hand sanitizers, 365 Handbook of Nonprescription Drugs, 374t Hangover, 534 Harkin, Senator Tom, 158 Harper, Dr. Alfred E., 199 Hart, Fred J., 227 Hartman, Samuel Brubaker, 356 Harvard Health Letter, 25t, 76, 99 Hatch, Senator Orrin, 150 Hauser, Gayelord, 217 Hay fever, 295, 296, 366t HCG; see Human chorionic gonadotropin HDL (high-density lipoproteins), 242,
308–310, 310t, 311, 312, 316t, 320, 325, 534
and alcohol, 319 and heart attack risk, 177, 308t, 309,
310t, 534 Healey, John A., 357 Health & Healing, 135 Health care attitudes toward, 36, 90, 134 costs; see also Expenditures, health care;
Fees ambulatory surgery, 457 anticancer drugs, 346 budgeting for, 492 cost-control methods, 492–494, 496 dental care, 112, 490, 491t exercise facilities, 276 eyeglasses, 423–424 guidelines for reducing, 375–376, 496t hearing aids, 428 home care, 460–461 hospice care, 444 hospital care, 492 long-term–care insurance, 481–482 mental help, 97 nursing homes, 462, 492 physician services, 490, 491t problems with, 8 urgent care centers, 456 dental; see Dental care emergency, 74, 455 facilities, 454–466 ambulatory surgery centers, 457 hospices, 443–444, 535 hospitals; see Hospitals nursing homes; see Nursing homes outpatient, 454–457, 456t scope and relative cost, 456t, 465t urgent care centers, 456 home care services, 460–461 medical; see Medical care mental; see Mental health care palliative, 443 personnel, types and training of allied health professionals, 71t, 112–113 dentists, 112 medical doctors, 66–67 medical specialists, 68t mental health professionals, 90–92 nurses, 69–70, 91 nutrition professionals, 192
optometrists; see Optometrists osteopathic physicians, 67–69 pharmacists; see Pharmacists podiatrists, 69, 270 questionable; see “Alternative” health
care reform conflicting attitudes toward, 490 need for, 486, 499 proposals for, 500–501 science-based, 65–88 scope of practice, 66 selection of practitioners chiropractor, 172 dentists, 126–128 infertility specialist, 411 mental health practitioner, 97–98 nutrition adviser, 192 obstetrician, 413 physicians, 70, 72–73 plastic surgeon, 393–394 surgeon, 80–81 surgical; see Surgery Health care flexible spending accounts
(HCFSAs), 476 Health Care Technology Institute, 490 Health clubs and spas, 277–278 Health devices; see Devices, health Health Employer Data Information System
(HEDIS), 477–478 “Health foods,” 195, 197, 197t, 207–208,
209–212t, 221, 223 Health Fraud Discussion List, 301–302, 520 “Health freedom,” 41, 43–44, 158, 227,
329, 515, 534 Health Freedom News, 227 Health maintenance organizations (HMOs),
475–476, 477t, 535 subscriber satisfaction, 478 types, 475–476 Health on the Net (HON) Foundation, 29 Health reimbursement arrangements
(HRAs), 476 Health Research Group (HRG); see Public
Citizen Health Research Group Health savings accounts (HSAs), 476 Healthcare Integrity and Protection Data
Bank (HIPDB), 519 Healthcare Rights Amendment, 43 Health-food industry, trade organizations,
238 Health-food stores, 224 products sold in, 140, 209–212t HealthKeepers Alliance, 43, 344 HealthMed, 106 HealthNotes, 215t HealthScan America, 50 Healthwise Handbook, 300 Healthy Eating Index (HEI), 535 Hearing aids, 427–429 Hearing loss, 427–428, 428t Heart attacks, 332 Heart failure, 535 Heartburn remedies, 364
Helicobacter pylori, 331, 363 Helsinki Hair Formula, 389 Hematoma, definition, 535 Hemochromatosis (iron overload), 372, 404 Hemoglobin A1C test, 76 Hemoglobin test, 76 Hemorrhage, 535 Hendler, Dr. Sheldon Saul, 223 Hennekens, Dr. Charles, 535 Henny, Dr. Jane, 355 Hepatitis, 78, 142, 293t, 316, 331, 388, 390,
392, 405, 407, 412t, 535 Herbal Medicines, 215t Herbalife International, 61, 250 Herbert, Dr. Victor, 5, 22, 175, 182, 195,
220, 223, 503 Herbs, 6, 213–216, 214t, 215t, 223, 535 dangers of, 214t, 216, 224 marketing of, 56t, 198 medicinal use, 213–216 popular, 214t Herd immunity, 290 Heritage House Web site, 410 Herniated disk, 535 Herpes infections, 52, 405–406, 407, 535 Heterosexual transmission (of disease), 535 High blood pressure, 320–322 self-monitoring, 298, 300 sodium and, 187, 190t, 321 High Cost of Dying, The, 447 High-density lipoproteins (HDL); see HDL Hill-Burton Act, 455 Hinn, Benny, 149 HIPAA, 86, 441, 474, 482, 519 Hippocrates, 260 Hirsutism, 387, 388 HIV/AIDS, 530 costs, 488 denial, 5 HAART treatment, 406 quackery and fraud, 432 screening test, 412t transmission, 405, 406, 408, 414 Hives, 295 HMOs; see Health maintenance
organizations Hoffman, Bob, 284 Hoffman, Cecile, 344 Hohensee, Adolphus, 218 Holistic Dental Association, 158 “Holistic dentistry,” 124 “Holistic medicine,” 136, 535 Holmes, Oliver Wendell, 33 Home birth, 413–414 Home care services, 450–461 Home medicine cabinet, 373, 373t Home Shopping Network, 389 Homeopathy, 34, 137–141,535 advertising, 56 attitude of pharmacists toward, 353 Bach remedies, 99 “constitutional remedy,” 138 dubious products, 7, 56, 140, 157, 250, 405 and electrodiagnosis, 139
Index 553
and FDA regulation, 140 media reports, 134 and personality type, 138 “provings,” 137 research findings, 139–140 use by chiropractors, 172 Homocysteine, 307, 320, 535 Homœopathic Pharmacopœia, 138–139 HONcode, 29 Honey, 111–112 Hoodia gordonii, 244–245 Hormone replacement therapy, 415–416 Hormone, definition, 535 Horoscope, 535 Hospices, 443–444, 535 Hospital Santa Monica, 227 Hospitalists, 459 Hospitals, 457–460 accreditation of, 81, 454, 455, 457–458 characteristics of good, 458 costs, 492 emergency departments, 74, 455, 456t free care at, 455 infections in, 84, 460 marketing by, 50–51 mental health care in, 96 number of, 457 outpatient clinics, 455 partial, 96, 538 Patient’s Bill of Rights, 459 peer review in, 457–458 and physician regulation, 457–458, 518 problems for consumers, 459–460 selection of, 458–459 strategies for patients, 74, 458, 460 types, 457 “Hot flashes,” 201, 415, 416 Hot tubs, 277 Householder, Michael and Carol, 252 How to Lie with Statistics, 17 Hoxsey, Harry, 336 Hoxsey treatment, 336 Hubbard, L. Ron, 105 Huff, Darrell, 17 Huggins, Dr. Hal A., 124, 126 Hughes, Mark, 250 Human chorionic gonadotropin (HCG), 412 Human immunodeficiency virus (HIV), 535 Humectants, 208, 281 Humidifiers, 439 Humphrey, Derek, 445 Hydroquinone, 384 Hydroxycitric acid, 245 Hydroxycut, 57 Hyperactivity; see Attention deficit disorder Hyperalimentation, 238 Hypercholesterolemia, 535 Hypertension; see High blood pressure Hyperthermia, 333, 535 Hypertrophic cardiomyopathy, 261 Hyperventilation syndrome, 96 Hypnosis, 94, 103, 104, 251, 290 dubious credentials, 92, 100 Hypoglycemia, 154, 535 Hysterectomy, 535
I Iatrogenic illness, 84, 535 Ibuprofen, 119, 360, 362–363, 362t, 366,
367, 535 ICD-10, 483, 535 Ideal Health International, 61–62 Idiopathic disease, 535 Ignarro, Dr. Louis J., 61 Image enhancement, 397–399 Imagery, mental, 342 Imaging procedure, definition, 535 “Immune boosters,” 42 Immunizations, 78 opposition to, 145, 172, 205, 209, 227,
229, 290–291 Immuno-augmentative therapy (IAT), 337,
342 Impaired physicians, 82, 535 In vitro, definition, 535 In vitro fertilization (IVF), 411 In vivo, definition, 535 Incidence, of disease, 535 Indemnity insurance, 470, 474, 477, 477t,
535 Independent practice association (IPA), 475 Index Medicus, 17 Indian Health Service, 481 Infectious Diseases Society of America, 156 Infertility, 411, 535 Infinity2, 220 Inflammation, 535 Influenza (lu), symptoms, 366t Infomercials, 4, 26, 57, 59t, 60–61, 63, 90,
250, 251, 345, 357, 385, 389, 516, 521, 522t, 535
Information sources, 2, 4–5, 19–31; see also Advertising
books and pamphlets, 24, 25–26 cancer, 344–345 dietary supplements, 215t drugs, 374t educational institutions, 21 evaluation of, 28–30 federal agencies, 517–518, 526 herbs, 215t hospital data, 459 for international travel, 72 magazines and newsletters, 24, 25t National Center for Complementary and
Alternative Medicine (NCCAM), 132, 157, 158–159
newspapers, 24 nonprofessionals, 20 nutrition, 24, 25t, 191–193, 221–227 online, 4, 27–30, 301–303 problems with, 2, 4–5, 19–30 professionals, 20 pseudoscientists, 20–21 radio and television, 4, 27, 344 self-help publications, 300 telephone advice, 74 trustworthy, 28t, 191–193, 345, 526–528 voluntary and professional organizations,
520–521, 526–528 Informed consent, 535
Injections, overuse of, 35, 82 Injunction, 535 Injury prevention, 268–269, 268t Inlay, dental, 119 “Innate Intelligence,” 135, 164 Inositol, 198, 211t Inpatient, definition, 469t, 535 Insect repellents, 391 Insect stings/bites, 295, 296, 360, 373t “Inside Edition,” 340 Insomnia, 7, 90, 94, 95, 159, 181, 214t, 237,
243, 366, 371–372, 535 Inspector General; see Office of the
Inspector General Institute for Aerobics Research Institute for Integrated Nutrition (IIN), 226 Institute of Medicine (IOM), 19, 66, 416,
462, 535 Institutes for Human Potential, 102 Insulin potentiation therapy (IPT), 341 Insurance, health, 467–486 assignment of benefits, 469t, 483 basic, 468, 470 benefits, 468, 470 claim form, 413 claim submission, 483–484 commonly used terms, 469t comprehensive, 468, 470–471, 532 contract provisions, 471, 474 dental, 482–483 dependent coverage, 471 disability, 484, 486 discount plans, 475 “dread disease,” 475 explanation-of-benefits (EOB) statement,
484, 485 fee-for-service plans, 477, 477t fixed dollar plans, 474–475 fraud and abuse, 157, 344, 442, 494,
497–498 funding out-of-pocket expenses, 492 group insurance, 478 health care flexible spending accounts
(HCFSAs), 476 health maintenance organizations (HMOs);
see Health maintenance organizations health savings accounts (HSAs), 476 history of, 468 hospital care, 470 indemnity, 470, 474, 477, 477t, 535 long-term care, 481–482 loss ratios, 478, 536 major medical, 470–471, 536 managed care; see Managed care Medicaid, 481 Medicare; see Medicare national health, 499–501, 537 point-of-service (POS) plans, 476, 477t portability, 469t, 474 preferred provider organizations (PPOs),
476, 477t, 538 resource-based relative value scale
(RBRVS), 484 selection, 478, 479t single-payer system, 500
Index554
Insurance, health—cont’d. “stop loss” feature, 470 types of plans, 474–476 uninsured, number of, 8, 498 Integrated health network, 535 “Integrative medicine,” 133–134, 535 Intelligence tests, 106 Intelligent health consumer and cancer, 345–346 and cardiovascular disease, 325 characteristics of, 11–13, 30–31 and chiropractors, 172 effective communication with physicians,
85–87 evaluation of health information, 28–29 filing of complaints, 522–523, 522t healthy lifestyle, 288–291 and home test kits, 294–295 and hospital care, 74, 458, 460 medication choice and use, 360,
373–376, 373t, 374t nutrition decisions, 228 reducing health-care costs, 375–376, 496 rights and responsibilities, 73, 495 and routine periodic interventions, 76–78 self-test, 2 shopping for eyeglasses, 423–424 Interferon, 333, 535 Interleukins, 333 Intermediate care, 462, 535 International Association for Medical
Assistance to Travelers (IAMAT), 72 International Association of Cancer Victors
and Friends, 344 International Cemetery, Cremation and
Funeral Association, 447 International Chiropractic Pediatric
Association, 172 International Chiropractors Association
(ICA), 165, 166, 172 International College of Integrative
Medicine (ICIM), 158 International Conference of Funeral Service
Examining Boards, 447 International Cosmetic Ingredient
Dictionary, 380 International Federation of Bodybuilders,
284 International Medical & Dental
Hypnotherapy Association, 92 International Olympic Committee, 284 International Society for Stem Cell
Research, 41 International unit (IU), 535 Internet and cancer quackery, 344, 345 drug advertising, 52 extent of health information, 4 FTC activities, 517 locating information, 27–28 and patient records, 74 pharmacy sales, 358, 376 and physician credentials, 72–73 prudent use, 27–29 recommended sites, 28, 526–528
signs of a misguided Web site, 27 testing services, 294 Internet Health Pilot, 28t, 72 Internship, definition, 535 Interpersonal psychotherapy, 93 Interro, 139 Interstate commerce, 535 Intervertebral disks, 536 Intraocular lenses, 426, 535 Intrauterine devices (IUDs), 406t, 408, 409 Intravenous, definition, 535 Iridology, 145–146, 536 Iron deficiency, 55, 206, 372, 404 infant needs, 184 overload, 372, 404 and pregnancy, 206 products containing, 372–373 Irradiation, food, 510–511 Irritable bowel syndrome, 299 Irvingia gambonensis, 245 Iscador, 339 Isokinetic exercise, 262, 536 Isometric exercise, 262, 536 Isotonic exercise, 262, 536 Isotretinoin, 385 ITV Direct, 516, 521 Ivy, Dr. Andrew C., 336
J Jackson, James Caleb, 217 Jacobson, Dr. Robert M., 287 Janssen, Wallace, 345 Jarvis, Dr. DeForest C., 217 Jarvis, Dr. William T., 5, 34, 38, 40, 41, 42,
43, 114, 165,185, 242, 334, 449, 451 Jaundice, 536 JCAHO, 536 Jenny Craig, 253, 254 Jensen, Dr. Bernard, 145–146 “Jock itch,” 405 Johns Hopkins Medical Letter, 25t, 216 Joint Commission on Accreditation of
Healthcare Organizations, 81, 454, 456, 457–458, 530
Journal of Longevity Research, 60 Journal of the American Medical
Association (JAMA), 17, 536 Juice Plus+, 62 Juicing, 213 Jungle, The, 506 “Junk food,” 186, 195
K Kaiser, Dan, 398 Kaiser Permanente, 476 Kallet, Arthur, 506 Kaplan Niles L., 1 Kasdan, Tracy Stople, 175 Kashgarian, Dr. Michael, 4 Kassirer, Dr. Jerome, 131 Kava, 99, 100, 214t, 216 Keeton, Kathy, 339 Kelley Malignancy Index, 343 Kelley, Dr. William, 343
Kellogg, Dr. John Harvey, 217, 369 Kellogg Company, 54 Keloids, 389 Kelp, 211t Kelsey, Dr. Frances O., 505, 507 Kennedy, President John F., 260, 504, 532 Kent, Saul, 449 Ketosis, 240–241, 253, 536 Keyes method of gum treatment, 116 Kickapoo Indian Medicine Company, 357 Kickbacks, 497, 498, 536 Kilbourne, Jean, 53 Kinesiology, 536 Kinoki Detox Foot Pads, 434 Kinsolving, Rev. Lester, 151 Kirlian photography, 148 Koch, Dr. William, 334 Koch, Robert, 67 Koop, Dr. C. Everett, 177 Kordel, Lelord, 218 Koren, 170, 171 Krebiozen, 336 Krieger, Dr. Dolores, 147 Kroger, Dr. Manfred, iii–iv Kuhlman, Kathryn, 149 Kurtz, Dr. Paul, 45 Kushi, Michio, 219 K-Y Jelly, 368, 408
L Labeling, legal definition, 536 Laboratory tests and procedures, 75–76 for cancer, 340, 343 dubious, 126, 139, 153, 155, 219–221,
340, 343 Internet-based, 294 pitfalls of standard tests, 82, 84 Lactose intolerance, 209t, 295, 299 Laetrile, 22, 43, 334, 336–337, 338, 343,
345, 513 Landers, Ann, 233 Lane Labs, 337 Lane, Dr. I. William, 337 Lanolin, 46, 381, 386 Lanou, Dr. Amy, 233 Laparoscopic surgery, 536 sterilization, 409 Larkin, M., 4, 23 Las Vegas Health Show, 24 Laser procedures dental drilling, 122 hair reduction, 387 laserpuncture, 141 phototherapy, 387, 396 refractive surgery, 426–427 LASIK, 427 Lasik Vision Institute, 50, 427 Latex allergy, 430 Laws; also see under Food, Drug, and
Cosmetic Act and cancer quackery, 346 Consolidated Omnibus Budget
Reconciliation Act (1986), 455, 474 Criminal Fine Enhancement Act (1984),
513
Index 555
Drug Price Competition and Patent Term Restoration Act (1984), 350, 354, 508
drug substitution, 354 Federal Anti-Drug Abuse Act (1988),
281 Federal Hazardous Substances Labeling
Act (1960), 505 Federal Rehabilitation Act (1973), 445 Federal Trade Commission Act (1914),
507, 515 Food, Drug, and Cosmetic Act (1938) Color Additive Amendments (1960), 505 Delaney Clause (1958), 505, 509 Dietary Supplement Health and Education Act (DSHEA), 43, 55, 63, 198, 228, 244, 507, 509, 534 Drug Abuse Control Amendments (1965), 505 Drug Price Competition and Patent Term Restoration Act (1984), 350, 354, 508 Durham-Humphrey Amendment (1951), 505 Fair Packaging and Labeling Act (1966), 505, 507, 508, 513, 515 Family Smoking Prevention and Tobacco Control Act, (2009) 54 FDA Modernization Act (1997), 191, 509 Food Additives Amendment (1958), 508 Food Quality Protection Act (1996), 509 General Agreement on Tariffs and Trade Act (1994), 351 Infant Formula Act (1980), 508 Kefauver-Harris Drug Amendments (1962), 505, 507, 510 Medical Device Amendments (1976), 421, 508 Medical Device Reporting Act (1984), 421 Nutrition Labeling and Education Act (1990), 509 Orphan Drug Act (1983), 508 Poison Prevention Act (1970), 508 Prescription Drug Marketing Act (1983), 508 Proxmire Amendment (1976), 199, 508 Public Health Service Act (1944), 505 Pure Food and Drug Act (1906), 505, 506 Radiation Control for Health and Safety Act (1968), 508 Saccharin Warning Elimination via Employing Science and Technology Act (2000), 247 Safe Medical Devices Act (1990), 421, 509, 512–513 Freedom of Access to Clinic Entrances
Act (1994), 410 Health Insurance Portability and
Accountability Act (1996), 86, 441, 474, 482, 519
Health Maintenance Organization Act (1973), 475
Hospital Survey and Construction Act (1946), 445
Mail Order Consumer Protection Amendments Act (1983), 507
“medical freedom,” 158 Mental Health Parity and Addiction
Equity Act (2008), 470 National Transplant Act (1984), 442 Newborns’ and Mothers’ Health
Protection Act (1996), 414, 470 Omnibus Budget Reconstruction Act of
1987, 462 Patient Protection and Affordable Care
Act (2010), 472-473t, 501 Patient Self-Determination Act (1990),
440 Physicians Payment Reform Act (1989),
481 postal; see U.S. Postal Service Sherley Amendment (1912), 505, 506 Uniform Anatomical Gift Act, 443 U.S. Organic Foods Production Act
(1990), 247 Laxatives, 369–370, 370t LDL (low-density lipoproteins), 177, 242,
308–310, 310t, 311, 312, 314, 315, 316, 316t, 318, 319, 325, 536
Leaky gut disease, 156 Learning disabilities, questionable
treatments, 102–104 Learning Machine, 99 LeBlanc, Dudley J., 357 Lecithin, 176, 211t, 218, 244, 307–308,
319, 509–510 Lederer, Dr. Roger, 21 Lederle Laboratories, 200 Lee, Dr. Royal S., 227 Lee, Samuel H.P., 356 Lefkowitz, Louis, 206 Legumes, 178, 185, 186, 312, 536 Leptoprin, 251 Lesion, definition, 536 Leukoplakia, 127, 536 Levitation, 153 Liaison Committee on Medical Education,
66 Libel suits, 23, 197t Licensed practical nurses, 70 Life expectancy, vii, 536 Lifesavers Guide to Fluoridation, 115 Lifestyle Lift, 396 Ligament, 536 Lightsey, David, 283 Lilienfeld, Dr. Scott O., 89, 103 Lindsay, Ronald, 13 Linoleic acid, 176, 245, 283 Linus Pauling Institute, 204 Lipid(s), 536; see also Fat(s) analysis (profile), 76, 309–310 blood, 307–309 dietary, 176–177 fatty acids, 314 Lipman, Dr. Marvin, 65
LipoBan, 245 Lipoprotein(a), 309 Liposuction, 249, 394t Lister, Joseph, 67 Listerine, 119 Lithium products, 95 Litt, Dr. Iris F., 401 Live-cell analysis, 220 Live-cell therapy, 338, 341 Living Bank, The, 443 Living Fuel Rx, 229 Living to 100 Life Expectancy Calendar,
450 Living wills, 438, 439 Livingston, Dr. Virginia, 341 Lobbying, top health-related spenders, 498t London, Dr. William M., iii, 520 investigations by, 167, 399 Long-term care, 536 comparison of facilities, 211t insurance, 481–482 Look Younger, Live Longer, 217 Loss ratios, 478, 536 Lourdes, 149 Lovastatin, 316t, 319 Lovaza, 314 Low-calorie products, 189t, 241, 246–248 Low-density lipoproteins (LDL); see LDL L-tryptophan, 225 Lukaski, Frank, 246 Lust, Benedict, 144 Lutz, William, 46 Lydia E. Pinkham’s Vegetable Compound,
356 Lyme disease, 154
M Ma huang: see Ephedra-containing products Macfadden Holdings, 284 Macfadden, Bernarr, 144, 217, 261, 284 Mackay, Dr. Judith, 305 Macrobiotic diets, 219, 338, 536 Macronutrients, 176, 242, 279, 536 Macular degeneration, 203, 422 Maggiore, Christine, 5 Magnet therapy, 432 Magnetherapy, Inc., 432 Magnetic resonance imaging (MRI), 79–80 Magnetic source imaging, 80 Magnetic Therapeutic Technologies, 432 Magnuson, Sen. Warren G., 503 Maharishi Ayur-Ved, 153–154 Maharishi effect, 152 Maharishi Mahesh Yogi, 152–153 Mail Order Consumer Protection
Amendments Act (1983), 507 Mail-order frauds health products, 6, 57–58, 59t laws protecting against, 507, 517 Major medical insurance, 470–471, 536 Malaise, 536 Malocclusion, 536 Malpractice, medical, 35, 84, 107–108, 536 Mammary artery ligation, 16 Mammography, 50, 77
Index556
Managed care, 474–477, 536 comparison with indemnity plans,
477–478, 477t Consumers’ Bill of Rights, 475 cost-control strategies, 492–493 definition, 469t, 474, 536 effect on pharmacists, 352 Medicare Advantage, 480 Mania, 536 Manic-depressive psychosis, 536 Manipulation adverse effects, 172–173 osteopathic, 67–68, 69, 166–167 skull, 103, 125, 147 spinal, 133, 164, 165, 169–170 Manner, Dr. Harold, 343–344 Manufacturer and User Facility Device
Experience (MAUDE), database, 421 March of Dimes, 412 Markers, 536 Marketdata Enterprises, 240 Marriage and family therapists, 92 Marriage counseling, 94 Marshall, Dr. Barry, 363 Martin, Dr. Robert, 275 Massage, 40, 132, 134, 137, 144, 147, 148,
249, 297, 302, 389, 531 Massage therapists, 7, 9, 21, 70, 147, 148 Materia medica, 137 Maximum heart rate, 263t, 264, 285,
323 Mayo Clinic Health Letter, 25t, 448 McCall, Dr. Timothy B., 72, 77, 85, 86, 287 McCarthy, Dr. Eugene, 81 McCue, Dr. Jack D., 440 McKay, Dr. Frederick, 114 MCT oil, 319 Meal-replacement products, 240, 241, 247 Media, 536; see also Advertising;
Information sources astrology columns, 152 coverage of “alternative” methods, 134,
159 effect of libel suits, 23 functions of, 4, 22 number of outlets, 4 as sources of misinformation, 22–27,
36–37, 38, 221–223 Medic Alert Foundation, 443 Medicaid, 481, 536 fraud, 128 nursing home coverage, 463 Medical assistants, 71t Medical care; see also Health-care,
personnel; Mental health care; Physicians; Surgery
abroad, 74 basic, 75–80 choosing a physician, 70, 72–73, 80, 393,
395 consultations, 85 emergency, 74, 455 ethical dilemmas, 84–85 financial abuse, 494 “get-acquainted” visit, 73
iatrogenic illness, 84 immunizations, 78 impersonal care, 83 incompetence, 82–83 laboratory tests and procedures, 75–76 malpractice, 35, 84, 107–108, 536 medical imaging; see under Medical
imaging patient-physician relationship, 83, 84,
85–86, 107–108, 539 periodic health examinations, 76–77, 423 physical examination, 75 prescientific era, 73, 157 quality of, 82–85 reasons for avoiding, 292, 294 sexual misconduct, 84 unscientific, 154–158 when to seek, 294 Medical devices; see Devices, health Medical doctors, training and credentials,
66–67, 68t, 84 Medical imaging, 79–80, 535 capsule endoscopy, 80 computerized axial tomography (CT or
CAT scan), 79 coronary angiography, 324 magnetic resonance imaging (MRI),
79–80 magnetic source imaging, 80 mammography, 50, 77 nuclear magnetic resonance (NMR),
79–80 positron emission tomography (PET), 79 radionuclide imaging, 79 single photon emission computerized
tomography (SPECT), 79 ultrasonography, 80; see Ultrasound
devices x-ray films; see X-ray examinations Medical Information Bureau, 86 Medical Letter, The, 141, 203, 212t, 216,
316, 319, 363, 389, 398, 399 Medical Overkill, 84 Medical records access to, 86 electronic, 493–494 on Web page, 74 Medical specialties and subspecialties, 68t Medical technologists, 71t Medical Tribune, 202 Medically indigent, 536 Medicare, 480–481, 536 chiropractic coverage, 164 and Christian Science, 150 and DRGs, 493 disciplinary action under, fraud, 497–498 hospice coverage, 444 hotline, 480 Medicare Advantage plans, 480 nursing home coverage, 463 prescripton drug coverage, 480 RBRVS fees, 484 supplemental (Medigap) insurance, 480 Medicine cabinet, products for, 373, 373t
Medicine shows, 357 Medicine, defensive, 84, 533 Medicines from Nature, 56t Medigap insurance, 480 Meditation, 100, 152–154 MEDLINE, 6, 17, 27, 28 Megavitamin therapy, 100–101, 203–206,
536 Meinig, Dr. George A., 124 Melanoma, 30, 391, 392 Melatonin, 211t, 450 Memorial societies, 446–447 Menopause, 415, 536 and heart disease, 306, 415–416 hormone-replacement therapy, 415–416 surgical, 415 Menstrual cups, 402 Menstrual problems, 403–404 Menstrual products, 402 Mental health care, 89–110 addiction help, 96–97 behavioral therapy, 93 biofeedback; see Biofeedback cognitive therapy, 93 cost, 97 drug therapy, 94–95 electroconvulsive therapy, 95 group therapy, 94 hospital care, 96 hypnosis; see Hypnosis insurance coverage, desirable, 471 practitioners, 90–92 psychosomatic disorders, 96 psychotherapy; see Psychotherapy questionable practices, 100–108 attachment therapy, 104 auditory integration training, 102 boundary violations, 108 chelation therapy, 102 Dianetics and “purification,” 105–106 Doman-Delacato treatment, 102 drugs, overuse of, 105 eye movement desensitization and reprocessing (EMDR), 102–103 facilitated communication, 103 false memory stimulation, 105 Feingold diet, 101–102 life coaching, 106 meditation, 100 megavitamin therapy, 100–101, 203–206, 536 Neural Organization Technique (NOT), 103 Neuro Emotional Technique (NET), 103 neurolinguistic programming (NLP), 104 past-life therapy, 104 psychic counseling, 106–107 psychotherapy, mismanagement of,
107–108 routine personality testing, 106 sensitivity training, 100 simplistic advice, 107 thought field therapy (TFT), 104
Index 557
questionable “self-help” products, 98–100
Bach remedies, 99 biofeedback gadgets, 99 “brain wave synchronizers,” 99 dietary supplements and herbs, 99–100 instructional programs, 99 subliminal recordings, 58, 98–99, 249 selection of therapist, 97–98 treatment planning process, 540 when needed, 98 Menthol, 361, 367, 405 Mercola, Dr. Joseph, 229 Meridian therapy, 536 Meridians, 139, 141, 142, 530 Mesmer, Franz Anton, 94 Mesotherapy, 395 Meta-analysis, 537 Metabolic equivalents (METs), 266–267,
537 Metabolic therapy, 343–344, 537 Metabolism, definition, 537 Metamucil, 368, 370t Metastasis, 332, 537 Metchnikoff, Elie, 369 Methadone maintenance, 97 Metropolitan Life Insurance Company, 235 Micro-dentistry, 123 Micronutrients, 176, 537 Microsoft HealthVault, 74 Midwives, 70, 413–414 Miles Laboratories, 202 Milk thistle, 214t Milk, 186 certified, 212t raw (unpasteurized), 212t, 213, 218,
520 Miller, Roger, 45 “Mind-body exercise,” 267–268 “Mind-body medicine,” 135 Mindell, Earl, 229 Minerals, 179 and hair analysis, 239–240 calcium; see Calcium chelated, 208t–209t dangers of excess, 206 electrolytes, 179, 533 fluoride; see Fluoridation; Fluoride food sources, 178t iron; see Iron of special concern, 186, 187; see also
Iron sodium; see Sodium Minnesota Multiphasic Personality
Inventory (MMPI), 106 Minoxidil; see Rogaine Mintz, Morton, 349 Mirena IUD, 406, 408 Mirkin, Dr. Gabe, 13, 244, 311, 314 Misbranding, 509, 537 Miscarriage, 537 Misconceptions bowel, 369 “detergent foods,” 116 about exercise, 281t
about eyesight, 426 about generic drugs, 355 about placebo effect, 103 about quackery, 38 about sugar, 102, 113, 124, 177, 239t about weight control, 239t homeopathic products resemble vaccines,
138 nutrition, 197 “pop psychology” myths, 103 Mishra, Raja, 282 MMR, 537 Moisturizers, 379, 381–382, 383, 387 Monoclonal antibodies, 333 MORAs, 125 Morbidity and Mortality Weekly Report
(MMWR), 518 Morbidity, 537 “Morning-after pill,” 409 Morowitz, Dr. Harold J., 194 Mortality, 537 Morticians, 445 Mosenkis, Robert, 421 Motion sickness remedies, 372 Motor fitness, 263 Mourning, 448 Mouthguards, 125 Mouthwashes, 118–119, 367 Mowrey, Daniel B., 251 Moxibustion, 141 MRFIT, 309 MRI, 50, 79–80, 324 Mucorhicin, 337 Mucous membrane, 537 Multilevel marketing, 7, 20, 35, 61–62 FreeLife International, 225 and FTC Business Opportunity Rule, 61 Herbalife International, 61, 250 Ideal Health, 61–62 income from, 61 Infinity2, 220 Juice Plus+, 62 National Safety Associates, 62 Nature’s Sunshine Products, 243 The Trump Network, 62 United Sciences of America, 20 use of endorsements, 20 Multiple chemical sensitivity, 154–156 Multivitamins, ingredients in, 199 Muscle & Fitness magazine, 24, 25, 283 Muscle spasms, 266, 268t Muscle testing, 105, 220; see also Applied
kinesiology MuscleTech, 57 Muscular Development magazine, 284 Musgrave, Dr. Katherine, 282 Mustard bath, 302t Myocardial infarction, 307, 322 MyPyramidTracker Web site, 312 MyPlate, 183, 199 Myths; see Misconceptions
N Nabothian cysts, 35 Nader, Ralph, 520
Naessens, Gaston, 340 Naprapathy, 537 Narcotics Anonymous, 97 Narcotics, in patent remedies, 356–357 National Academy of Sciences, 18 diet and cancer report, 333 Food and Nutrition Board, 181 Institute of Medicine, 19, 66, 416, 462,
535 National Research Council, 99, 100, 104,
187, 331, 435, 537 Recommended Dietary Allowances; see
RDAs National Advertising Division, 62–63, 345,
521, 522t National Advertising Review Board
(NARB), 62 National Ambulatory Medical Care Survey,
454–455 National Association for Home Care and
Hospice, 444, 460, 461 National Association of Attorneys General,
518 National Association of Boards of
Pharmacy, 358 National Association of Certified Natural
Health Professionals (NACNHP), 226 National Association of Social Workers
(NASW), 91 National Board for Certified Counselors, 91 National Board of Dental Hygiene
Examination, 113 National Board of Hearing Instrument
Specialists, 429 National Board of Medical Examiners, 67 National Cancer Institute, 28t, 192, 330,
331, 332, 337, 444 National Center for Complementary and
Alternative Medicine (NCCAM), 132, 157, 158–159
National Center for Homeopathy, 134, 140 National Cholesterol Education Program,
310–312, 325 National Coalition on Health Care, 488, 500 National Committee on Quality Assurance
(NCQA), 477–478 National Council Against Health Fraud,
126, 216, 240, 283, National Dairy Council, 521 National Enquirer, 284 National Fraud Information Center hotline,
62 National Guideline Clearinghouse (NGC),
18 National Guild of Hypnotists, 92 National Health and Nutrition Examination
Survey (NHANES), 234 National Health Association, 145 National Health Council, 495 National Health Federation (NHF), 43, 227,
344 National Health Information Center
(NHIC), 518 National health insurance; see Insurance,
health, national
Index558
National Health Interview Survey (NHIS), 134, 149
National Health Service Corps, 472t National Hospice and Palliative Care
Organization (NHPCO), 443, 444 National Institutes of Health (NIH),
517–518 consensus statements, 18, 132, 142,
158–159, 186 National Center for Complementary and
Alternative Medicine, 132, 158–159 Obesity Task Force, 253 Office of Alternative Medicine, 158 Office of Dietary Supplements, 215t, 509 National Mental Health Consumer Self-
Help Clearinghouse, 301 National News Council, 23 National Nutritional Foods Association, 228 National Practitioner Data Bank, 519 National Preventive Dentistry Program, 115 National Research Council, 99, 100, 104,
187, 331, 435, 537 National Safety Associates, 62 National Task Force on the Prevention and
Treatment of Obesity, 237, 241 National Vitamin Gap Test, 221 National Weight Control Registry, 241 Natural Cures “They” Don’t Want You to
Know About, 42 “Natural” foods, 114, 207–208 Natural hygiene, 145, 242, 537 Natural Medicines Comprehensive
Database, 215t, 216 Natural Pharmacist, 215t Natural Products Association, 228 Natural Standard database, 215t Naturalife herbal products, 56t Naturally Good, 514t Nature’s Sunshine Products, 243 Naturopathy, 7, 9, 40, 134, 135, 136,
143–145, 172, 433, 537 Nearsightedness, 421, 422 Necrotic tissue, 537 Negative ion generators, 341, 434 Negative test result, definition, 537 Nelson, Dr. Merlin, 223 Neonatal intensive care units, 445 Neotame, 247 Neural Organization Technique (NOT), 103 Neural tube defects, 186, 190t, 191, 412,
445 Neuralgia-inducing cavitational
osteonecrosis (NICO), 125 Neuro Emotional Technique (NET),
103–104 Neurolinguistic programming (NLP), 104 Neurotic reaction, 537 “New drug,” 505, 507, 508, 509, 511, 537 New drug application (NDA), 511–512 New England Journal of Medicine, 17 New Womyn, 398 Newborns’ and Mothers’ Health Protection
Act (1996), 414, 470
Newsletters, 24, 25t Newsweek, 24, 26, 30 Niacin adverse effects, 205, 316–317 for cholesterol control, 316–317, 316t for “purification,” 106 Nicotine replacement therapy, 289–290, 370 Niehans, Dr. Paul, 341 Nirvana, 152 Niteworks, 61 NMR, 79–80 Nocebo effects, 40, 537 Nolen, Dr. William A., 149 Nonaccredited schools, 225–226 Nonoxynol-9, 408 Nordenberg, Tamar, 401 Nosocomial infection, 537 Nosodes, 140 NSAIDs, 362–363, 362t, 403 Nuclear magnetic resonance (NMR),79, 324 Null, Gary, 26, 205, 344 Nurse’s aides, 71t Nurses nurse practitioners, 66, 69–70, 455, 493 psychiatric, 91 types of, 69–70 Nursing care levels, 462, 465t Nursing homes, 7–8, 453, 461–464 alternatives to, 465t cost of, 462, 463, 492 Patient’s Bill of Rights, 463 NutraSweet; see Aspartame Nutri-Books, 222 Nutrient(s) adequate intake (AI), 181 essential, 181, 182, 254, 534 estimated average requirements (EAR),
181 food sources, 178t major functions in body, 178t Recommended Dietary Allowances; see
RDAs tolerable upper intake level (UL), 181 “Nutrient deficiency tests,” 124–125,
220–221 Nutrient density, 179, 181, 182, 537 Nutrifirm Vitamin H Serum, 389 Nutripathy, 537 Nutri/System, 253, 254 Nutrition, 175–194; see also Diets; Food;
Food faddism; Vitamins; Weight control
Daily Values (DVs), 187t, 188, 509 diet and heart disease; see Cardiovascular
disease, and diet dietary evaluation, 183 dietary guidelines; see Dietary guidelines fads, fallacies, and scams, 196–232 food group systems, 182 Food Guidance System (MyPlate), 183 for athletes, 279–280, 281t human nutrient needs, 179–187 infant feeding, 183–184, 424–425
labeling, 187–191, 246–247, 315, 509 descriptive terms, 189t, 246–247 permissible health claims, 190–191,
190t sample food label, 188 major food components, 176–179 nutrients of special concern, 186–187 principles of healthful eating, 182 professionals, 192 quackery; see Food faddism questionable, promoters of, 124, 217–227 questionable, promotion of, 221–227 trustworthy information sources,
191–193 USDA Food Guidance System, 183 vegetarian, 184–185 Nutrition Action Healthletter, 25t, 520 Nutrition Business Journal, 198 Nutrition consultants and counselors,
225–227 “Nutrition insurance,” 56t, 199–200, 201t Nutrition Labeling and Education Act, 509 Nutrition News, 222 Nutrition “roulette,” 199 Nutritional Health Alliance, 228 Nutritionists licensing of, 192 sports, 270 trustworthy, 192–193 unqualified “consultants,” 7, 225–226 NuvaRing, 406t, 409
O Oat bran, 178, 312, 313, 315 Obesity causes, 234, 239t clinics, 252–253 definition, 234, 537 health risks, 235–236, 288–289 prevalence, 234 prevention, 236 Obsessive-compulsive disorder, 95, 537 Occillococcinum, 7 Occlusion, 537 Occult blood, 537 test for, 76, 78 Occupational therapists, 71t Octacosanol, 211t, 215t Office of Dietary Supplements, 215t, 509 Office of the Inspector General, 518 chiropractic reports, 169 and health fraud, 497, 498 Offit, Dr. Paul, 23, 525 Ohsawa, George, 219 Olestra (Olean), 248 Ombudsman, 537 Omega-3 fatty acids; see Fish oils Oncologist, 537 Online Survey Certification and Reporting
System (OSCAR), 462 Open enrollment, 469t Operation CureAll, 517 Operation Disconnect, 62
Index 559
Operation Sentinel, 62 Ophthalmologists, 422 Opportunistic infection, 537 Opticians, 422 Optifast, 253 Optometrists, 422, 423, 424 and visual training, 104, 426, 540 Orderlies, 71t Oreck Corporation, 291 Organ donor card, 443 Organ Procurement and Transport Network
(OPTN), 442 Organ transplants, 442–443 “Organic” foods, 5, 27, 206–207, 208 Organic Foods Production Act, 207 Orgone Energy Accumulator, 341 Oriental medicine, 141–143 Orlistat, 243 Ornish, Dr. Dean, 315 Orphan drugs, 508 Ortho Evra patch, 406t, 409 Orthodontics, 112, 120 Orthomolecular therapy, 100–102, 537 Orthopedists, 68, 270, 457 Orthorexia nervosa, 197 Oscilloclast, 433 Osler, Sir William, 65, 349 Osteoarthritis, 296 Osteopathic physicians, 67-69, 537 Osteoporosis, 190t, 206, 293t, 415, 537 Otitis, definition, 537 Otolaryngologists, 68, 393, 427, 428, 429 Outcomes research, 15–16, 537 Outpatient, definition, 469t, 537 Overeaters Anonymous, 252 Over-the-counter (OTC) drugs; see Drugs
and drug products, over-the-counter Overweight, 234, 538; see also Obesity Ovulation, 407, 408, 409, 538 Ovulation-prediction test, 407 Oxygen debt, 262 Oxygen inhalation, by athletes, 282
P PABA (para-aminobenzoic acid), 198, 211t,
449 Page, Dr. Melvin, 124 Pain relievers; see Analgesics Pain Stops Here!, Inc., 432 Palliative care, 443, 538 Palmer, Bartlett Joshua, 154 Palmer, Daniel David, 154 Palpitation, 538 Panic attack, 95 Pantron I Corporation, 389 Papain, 211t Papanicolaou (Pap) test, 76, 77 Paracelsus, 39 Paradigm, 538 Paragard IUD, 406t, 408, 409 Paramedics, 71t Paranormal, definition, 538 “Parasites,” fad diagnosis of, 156 Parikh, Dr. Rahul, 385 Park, Dr. Robert L., 138
Partial hospitalization, 96, 538 Participating provider, 469t Partnership for Prescription Assistance, 376 Partnership for Prevention, 493 Pasteur, Louis, 67 Past-life therapy, 104 Patent medicines, 356–357, 538 Patenting requirements, 55 Patient package inserts (PPIs), 51, 52, 374,
376, 409, 512, 538 Patient representatives, 71t Patient, intelligent; see Physicians,
communication with, effective Patient’s Bill of Rights, 538; see under Bill
of Rights Patient-physician relationship, 73, 83, 84,
85–87 and psychotherapy, 107–108 Patterning, 102 Pau d’arco tea, 338 Pauling, Dr. Linus, 204 Pavlou, Dr. Konstantin, 233 PC-SPES, 340 PDR for Herbal Medicines, 215t Pearson, Dr. Gregory W., 386 Pearson, Durk, 246, 449 Pectin, 245 PediaLean, 251 Peer review, 469, 538 by hospital committees, 9t, 457–458, 493 lack of, among journalists, 23, 26 by scientific organizations, 17–18, 19 Penis enlargement, 46, 398–399 Pennyroyal, 216 Peptic ulcers, 363 Pepto-Bismol, 363, 368 Percent Daily Values, 188 Percussion, 538 Performance-enhancing products, 424 Peridex, 118–119 Periodontal disease, 115–116, 122, 538 Periodontics, 112 Perkins, Elisha, 433 Permanent makeup, 389–390 Perricone, Dr. Nicholas, 26, 242, 382–383 Perricone Weight-loss Diet, 242 Personal care facility, 211t Personal emergency response systems, 430,
465t Personal health and safety, 286–304; also
see under Self-care health-promoting behaviors, 288–291 indoor air quality, 91 managing chronic disease, 295–301 and risk perception, 8, 292 safety measures, 291 smoking cessation, 289–290 vaccination, 290–291 Personal injury mills, 494 Personal trainers, 269, 270t Personality tests, 106 Peruna, 356 Pesticide levels, in foods, 207, 218 PET scan, 79 pH, 381
Phakoemulsification, 244 Phalloplasty, cosmetic, 398–399 Pharmacists, 351 advice from, 223–224, 352–353 compounding, 353, 532 role in promoting food supplements, 35,
223–224, 352 and tobacco products, 351 Pharmacognosy, 538 Pharmacy Checker, 358, 376 Pharmacy technicians, 351–352 Pharmanex, 203 Phenteramine, 243 Phenylketonuria, 247 Phenylpropanolamine (PPA), 244 Phillips, Dr. William P., 336 Phishing, 517 Phoropter, 423 Photochromatic lenses, 425, 538 Photodynamic therapy, 333 Phototherapy, 397–398 Phrenology, 217, 538 Physical Culture magazine, 284 Physical examinations, 75–78 by dentists, 127 procedures, 75 recommended frequency, 76 Physical fitness; see Exercise and fitness Physical therapists, 71t, 125, 147, 165, 166,
170, 461 Physician assistants (PAs), 71t Physician Data Query (PDQ), 345 Physician(s); see also Medical care characteristics of good, 72 communication with, effective, 85–86 directories, 490 education of, 66–67 ethical dilemmas, 84 fees, 490, 491t grievance, handling a, 87 impaired, 82, 535 medical care, quality of, 82–85 medical doctors, 66–67 meeting prospective, 73–74 and nutrition advice, 191–192 osteopathic physicians, 67–68 plastic surgeons, 393, 395 regulation of, 7, 518–519 Physicians—cont’d. selection of, 70, 72–74, 80–81, 393, 395,
413 specialties and subspecialties, 68t sports medicine specialists, 270 telephone tips, 86–87 unscientific, 154–158 when to consult, 294 Physicians Payment Reform Act (1989),
481 Physicians Weight Loss Centers, 254 Physicians’ Desk Reference (PDR), 52, 374t Physicians’ Health Study, 17, 318 Physicians’ Working Group for Single-
Payer National Health Insurance, 500 Phytochemicals, 202–203, 538 Pies, Dr. Ronald, 97
Index560
Pilates, 267 Pill-splitting, 376 Pinhole glasses, 425 Pinnacle Marketing Concepts, 251 Pitofsky, Robert, 518 Pityrosporum ovale, 387 Placebo definition, 538 in controlled studies, 15 Placebo effect, 15, 39–41, 39t, 538 Plan B, 409 Planned Parenthood, 407, 410 Plantar, definition, 538 Plaque atherosclerotic, 157, 306–307, 308, 309,
316, 325–326, 538 dental, 115–116, 117, 118, 119, 121, 538 Plasma, 538 Plastic surgery; see Cosmetic surgery Platelets, 538 Plax, 119 Podiatrists, 69, 270, 487 Point-of-service (POS) plans, 476, 477t,
538 Poison ivy/oak/sumac, 390–391 Poland, Dr. Gregory A., 287 Polaroid lenses, 425 POLST Paradigm program, 440 Popoff, Peter, 38, 149 “Poppers,” 416 Portability (of insurance), 469t, 474 Portal of entry, 538 Positive test, definition, 538 Positron emission tomography (PET), 79 Post hoc, ergo propter hoc fallacy, 17 Post, Charles W., 217 Postal Service; see U.S. Postal Service Potentially preventable readmissions, 473t,
538 Potentials Unlimited, 514t Power Balance bracelets, 434 Powwow, 133 PPACA, 472-473t, 501 Practical nurses, 70 Prana, 135 Pratkanis, Dr. Anthony R., 37 Precertification, 538 Precursor, 538 Pre-existing illness, 469t, 471, 472t, 499 Preferred Provider Organizations (PPOs),
476, 477t, 482, 538 Pregnancy and alcohol, 289 and aspirin, 361 and folic acid; see Folic acid and HIV screening, 412t iron supplementation, 206 prenatal care, 412–413, 412t tests for, 412 tubal, 540 unwanted, 401, 410 Premenstrual dysphoric disorder (PMDD),
403–404 Premenstrual syndrome (PMS), 206,
404–404, 538
Prenatal care, 412–413, 412t Presbyopia, 302t, 421, 423 Prescription drugs, 538 marketing of, 51–53 federal requirements, 511–512 Prescription for Nutritional Healing,
222–223, 224 Prescriptions how to read, 352, 353, 353t obtaining a refill, 87 President’s Council on Physical Fitness,
Sports & Nutrition, 261 Prevalence, definition, 538 Prevention, types (levels), 288 “Preventative maintenance,” by
chiropractors, 133, 171 Prevention magazine, 223 Preventive Medicine Research Institute, 315 Price, Dr. Weston A., 124 Price-Pottenger Nutrition Foundation, 124 Primary care, definition, 66, 538 Primrose oil, 210t Princeton Brain Bio Center, 101 Principia College, 150 Pritikin diet, 315 Privacy, of medical information, 86, 303 PrivaTest, 61–62 Proactiv System, 385 Procaine tablets, 449 Progesterone/progestin, 401, 408, 409, 415 Prognosis, definition, 538 Program of All-Inclusive Care for the
Elderly (PACE), 481 Project Cure, Prometheus Books, 26 Propecia, 388–389 Propionate, 510 Propolis, 211t–212t Prostaglandins, 317, 410, 538 Prostate-specific antigen (PSA) test, 77 Prosthesis, definition, 538 Prosthodontics, 112 Protection, consumer; see Consumer
protection Proteins, 176 complete, 176, 532 sources, 178t supplements, 212t, 281t Protocol, experimental, 538 Proton pump inhibitors, 364 Provider, definition, 469t Proving, homeopathic, 139 Provocation-neutralization tests, 155 Provoked urine testing, 157 Proxmire Amendment, 199, 508 Prozac, 95, 106, 404 Pseudoscience, 20–21, 538 Psoriasis, 387 Psychiatric nurses, 91 Psychiatric treatment; see under Mental
health care Psychiatrists, 90 Psychic counseling, 106–107 Psychic healing, 148–151, 538 Christian Science, 149–150
evaluation of, 151 evangelical healers, 38, 151 fraud in, 38, 149 Kirlian photography, 148 intercessory prayer, 150 psychic surgery, 150–151, 539 therapeutic touch, 147 Psychoanalysis, 93 Psychoanalysts, 91 Psychologic testing, 106 Psychologists, 90–91, 106, 270 Psychomotor retardation, 539 Psychoneuroimmunology, 539 Psychosomatic disorders, 96, 539 Psychosurgery, 539 Psychotherapy, 93, 539 mismanagement of, 107–108 satisfaction with, 98 Psychotic reactions, 94, 95, 539 Psychotropic drug, 539 Psyllium, 245, 299, 312, 368, 370t Public Citizen Health Research Group, 7,
519, 520 Publication bias, 18–19 Puffery, 4, 48, 539 Pulp, of tooth, 113, 120 Pulse diagnosis, 142, 153, 532 Pulse monitors, 271, 274, 326 Pulse, target for aerobic exercise, 263 Pure Food and Drug Act, 505, 506 Purell hand sanitizer, 365 “Purification program,” 105 Pyorrhea, 539 Pyridoxine; see Vitamin B6
Pyruvate, 245, 283
Q Q-ray bracelets, 434 Qi, 141, 143 Quack(s) characteristics, 5, 34, 41–42, 42t, 197t definitions, 5, 34 self-deception, 38, 41 types, 41 Quackery and frauds, v, 5–6, 33–44;
see also “Alternative” health care; Enforcement actions; Quacks; Mental health care, questionable practices
breast enlargement claims, 58, 398 cancer; see Cancer treatment,
questionable methods Congressional investigation of, 36 cost, 35 dangers, 37–38, 449 definitions, 5, 34–35, 539 dental, 124–126 device; see Devices, health, quack fad diagnoses, 36, 72, 125–126, 154–156 food faddism; see Food faddism freedom of choice issue; see “Health
freedom” hair-growth frauds, 389 insurance fraud, 157, 344, 442, 494,
497–498 life extension, 448–451
Index 561
mail-order products; see Mail-order frauds
misconceptions, 38–39 nutrition; see Food faddism promotion of, 7, 21–22, 34–35, 344–345 questionable diagnostic tests, 126, 139,
153, 155, 219–221, 340, 343 recognizing, 27, 41–42, 41t, 197t sex enhancers, 416 stem cell treatment, 451 telemarketing schemes, 62, 431, 517,
522t and terminal illness, 449 unscientific medical practices, 154–158 victims of, 5, 35, 36, 37–38, 103, 126,
146, 150, 151, 253, 342, 343, 433 vulnerability to, 5–7, 13, 36–37, 334–335 water purifier frauds, 430–431 weight control; see Weight control,
questionable products Quackwatch, 28, 29, 35, 191, 345, 346, 432,
520 Health Fraud Discussion List, 301–302 Quad screen, 413 Quality assurance, 469t “Quantum healing,” 135 QuickGymROM Machine, 276
R Radiation, minimizing, 79, 121–122 Radiation therapy, 332 Radionics, 341 Radionuclide imaging, 79 Radiopaque, definition, 539 Radon, 291, 292 and cancer, 331 RAND Corporation, 170 Randi, James, 38, 148, 149 Raphael, Sally Jesse, 340 Ravnskov, Dr. Uffe, 317 Raw foods, 213 Raw milk, 212t, 213, 218, 520 Razzouk, Dr. Nabil Y., 48 RDAs, 181, 539 RDIs, 188, 539 Rea, Dr. William J., 155–158 Rebound (from medication), definition, 539 Recalled by Life, 338 Recommended Dietary Allowances
(RDAs); see RDAs Recovery groups, 301 “Red flag” weight-control claims, 252 Red yeast rice, 319 Reference Daily Intakes (RDIs), 188, 539 References, how to locate, 12 Reflexology, 146, 539 Refractive surgery, 426–427 Regulatory letter, 539 Reich, Dr. Wilhelm, 341 Reiki, 147–148 Relman, Dr. Arnold S., 134, 144 Remission, definition, 539 Renewability (of insurance), 469t, 471 Renova, 383
“Rent-a-patient” scheme, 497 Rescue Remedy, 99 Research & Clinical Science (RCS), 172 Research design, 15–16, 16t Reserpine, 214 Residential care, 462 Resolve, 411 Resource-based relative value scale
(RBRVS), 484 Respiratory therapists, 71t Resveratrol, 212t Retin-A, 383, 385 Retina, 539 Revici, Dr. Emmanuel, 340 Review of Natural Products, 215t Revlon, 59 Reye’s syndrome, 361 Rheumatoid arthritis, 297 Risk-benefit analysis, 539 Risk factors, 539 for cancer, 330–301 for coronary heart disease, 306–309,
308t, 321 for osteoporosis, 415 for stroke, 321 Risk markers, 15, 536 Risk perception, 8, 292 Ritalin, 106 RNA/DNA, 212t Rodale, J.I., 223 Rodale, Robert, 206 Rodale Press, 223 Rogaine, 53, 388–389 Ronsard, Nicole, 249 Root canal therapy, 120 unfair criticism of, 124 Root doctors, 133 Rorschach inkblot test, 106 Rosa, Emily, 147 Rose, Dr. Louis, 151 Rosen, Dr. Gerald, 98 Roughage; see Fiber, dietary Rousseau, Jean-Jacques, 380 Rowing machines, 271 Royal jelly, 212t Rubella, 78, 293t, 412t, 539 Rutin, 198, 212t Rx symbol, 350
S Sabatier, Dr. Joseph Jr., 163 Saccharin, 8, 247, 292, 367 Safe Medical Devices Act of 1990, 421,
509, 512 Safety devices, 291 Sagan, Dr. Carl, 13, 14 Salt sensitivity, 539 Salicylic acid, 390 Sampson, Dr. Wallace I., 159, 337 Sandman, Dr. Peter M., 8, 292 Saraphem, 404 Sarcona, Frank, 245 Sargenti method, 120 Sarsaparilla, 213
Sattilaro, Dr. Anthony, 338 “Sauna shorts,” 278 Saunas, 277–278 Saw palmetto, 214t Scheel, John, 144 Schiavo, Terri, 441 Schizophrenia, 155, 203, 239, 539 Schlink, F.J., 506 Schuessler, Dr. W.H., 140 Schulte, Fred, 62 Science and Health, 149 Science-based medicine, 539 Scientific method, 14–16, 539 Scientific misconduct, 19 Scientific research, typical steps in, 16t Scientology, 105–106 Sclerology, 145 Sclerotherapy, 394t Scovill, Eliza Jane, 5 Screening test, 539 Sea salt, 212t Sealants, dental, 114 Sebaceous glands, 274, 384, 385, 386 Seborrheic dermatitis, 387 Sebum, 384, 385, 386 Second opinions, 81, 85, 297, 479t, 492,
495, 496 Secondary care, 539 Selenium, 191 Self magazine, 22 Self-care dental, 116–119 for irritable bowel syndrome, 299 home health library, 300 home medical tests, 294 Internet considerations, 301–303 Internet testing services, 294 publications, 300–301 questionable products, 98–100, 302t safety measures, 291 self-diagnosis, 47, 67, 292, 294 self-examination, breasts and testicles, 77 self-medication, frequency of, 359 Self-Help Group Clearinghouse, 301 Self-help groups, 301, 539 Semen, 410, 411, 539 Sensitivity (of test), 539 Sensitivity training, 100 Serophene, 411 Serotonin, 404 Serum, 539 “Set point,” 539 Seventh-day Adventists, 150, 185, 217, 289 Sex aids, phony, 6, 36, 46, 58, 59t, 209t,
398, 416, 431 Sex therapy, 92 Sexually transmitted diseases (STDs),
405–406, 539 Shaklee Corporation, 261 Shaklee, Forrest C., 261 Shampoos, 386–387 Shared decision-making, 539 Shark cartilage, 337, 338 Sharks Don’t Get Cancer, 337, 338
Index562
Shaw, Sandy, 246, 449 Shawnee Mission Medical Center, 83 Shelton, Herbert M., 145 Sherley, Rep. Swager, 506 Sherr, Jeremy, 139 Shiatsu, 536 Shock treatment; see Electroconvulsive
therapy (ECT) Shoes, for sports, 274 ShopSmart magazine, 379 Side effect, 539 SIDS, 539 Siegel, Dr. Bernie, 342 Sigmoidoscope, 539 Silicone implants, 397 Simonton, Dr. O. Carl, 342 Simple carbohydrates, 177, 539 Simplesse, 248 Simpson, Jessica, 385 Sinclair, Upton, 506 Singer, Dr. Barry, 21 Single photon emission computerized
tomography (SPECT), 79 Single-payer system, 539 “60 Minutes” (CBS-TV), 126, 337, 338 Skeptical Inquirer, 23, 520 Skeptics Society, 23, 520 Ski exercisers, 271 Skilled nursing care, 461, 462, 463, 465t,
539 insurance for, 470, 480, 481 Skin acne care, 384–386 bleaches, 384 cancer, 330, 331, 337, 382, 386, 391,
392, 393 care, 379–397; see also Cosmetic
surgery; Cosmetics changes with aging, 382 cross-section, 385 dry, 381 testing degree of oiliness, 381 Sleep adequacy, 291 Sleep aids, 371 Slim-Fast, 247 Slim-Skins, 249 Slimming soles, 250 Small Smiles clinics, 128 Smoke detectors, 291 Smokeless tobacco, 53 Smoking cessation benefits, 136, 203 methods, 289–290, 370–371 Snakeroot, 214 Soaps ad cleansers, 381 Social Security Act, funeral expense
payment, 446 Social workers, 71t, 91 Society for Cancer Research, 339 Society of Orthomolecular Medicine, 158 Sodium dietary, 180t, 183, 187 and food labeling descriptors, 189t, 190t and high blood pressure, 187, 190t, 321
Sodium benzoate, 119, 510 “Soldier’s sickness,” 357 Sore throat products, 367 South Beach diet, 241 Soy protein, and heart disease, 190t Spam e-mail, 28, 513, 517, 522t Spanish fly, 416 Specificity (of test), 539 SPECT, 79 SpectraCell Laboratories, 220 Speculum, 540 Speech pathologists, 71t Spider veins, 396 Sphygmomanometers, 298, 300, 320, 540 Spinal decompression machines, 431 Spinal manipulation, adverse effects,
172–173 Spirulina, 212t Splenda; see Sucralose Spondylolisthesis, 166 Spondylotherapy, 433 Spontaneous remission, 38–39, 332, 540 Sports bars, 280 Sports bras, 275 Sports drinks, 280, 281t Sports medicine specialists, 270 “Spot-reducers,” 275 Sprain, 540 Squibb, E.R., & Sons, 200, 201t SSRIs, 404 St. John’s wort, 214t, 216 Stair steppers and climbers, 271 Standard Process Laboratories, 227 Stanol esters, 190t Starch blockers, 245–246 Starches, 137, 190, 532 Statistics, misuse of, 16–17 Steiner, Dr. Rudolf, 139, 339 Stem cell treatment, 451 Stenger, Dr. Victor, 135–136 Stenosis, 540 Sterilization, surgical, 406t, 409–410 Steroid hormones “alternatives” to; see “Ergogenic aids” and allergies, 295, 296 precursers in dietary supplements, 284 use by athletes, 281–282 Sterol esters, 190t Sterol-enriched margarines, 319 Still, Dr. Andrew Taylor, 67–68 Stimulants for fatigue, 371, 371t Stop-loss provisions, 470 Strain, 540 Straus, Charlotte Gerson, 338–339 Strength training, 261, 262, 267, 274 Streptococcus B screening, 412 “Stress supplements,” 200, 201t, 202 Stress testing, 540; see Exercise testing Stresstabs, 200, 201t Stretching, 266 Stroke, 306t, 312, 540 chiropractic manipulation and, 172–173 risk factors, 187, 305, 321, 409 warning signs, 322
Student health services, 455, 456t, 478 Stutz, Dr. David R., 85 Stye, 367–368 Subcutaneous, definition, 540 Subliminal recordings, 58, 98–99, 249 “Subluxations,” 164, 165–168, 171–172,
224 Subscriber (insurance), definition, 469t Substance abuse counselors, 92 Succussion, 138 Sucralose, 247 Sucrose, 177 Sugar, 177 myths about, 113–114, 124, 177 role in tooth decay, 113–114 Sugar alcohol, and tooth decay, 118,
190t “Sugar blockers,” 246 Sugarless gum, 118 Suicide, assisted, 444–445 Sulfanilamide elixir, 506–507 Sun protection factor (SPF), 391, 540 Sunette, 247 Sunglasses, 424–425 Sunlamps, 386, 392 Sunlight, protection from, 391–393 Superoxide dismutase (SOD), 212t, 339,
450 Supplements; see Dietary supplements Supportive psychotherapy, 93 Suppositories, 540 Surgery, 80–82 abortions, voluntary, 414 ambulatory, 81, 457 breast-reduction, 397 cancer, 332 cardiovascular, 324–326 cataract, 426 cesarean delivery, 414 choosing a surgeon, 80–81 circumcision, 82 cosmetic; see Cosmetic surgery gallbladder, 81–82 knee, 82 laser; see under Laser procedures oral, 112 patient responsibility, 81 physician responsibility, 81 plastic; see Cosmetic surgery preparation for, 80–81 psychic, 150–151, 539 psychosurgery, 539 refractive, 426–427 second opinions about, 81, 492, 496 sterilization, 406t, 409 unnecessary, 81, 540 weight control, 248 Sustainable agriculture, 207 Swan, Dr. Rita, 150, 151 Sweatsuits, rubber, 275 Synthesis, definition, 540 Systematic reviews, 18 Systemic, definition, 540 Szasz, Dr. Thomas, 106
Index 563
T Tabloid newspapers, 24 advertising in, 59t Tagatose, 248 Tai chi, 267–268 Take Care of Yourself, 300 Take Control, 319 Talbott, Dr. Shawn M., 251 Tampons, 402 Tanning accelerators, 392 devices, 392 sunless, 392–393 Tardive dyskinesia, 95 Tattoos, 389–390 Taubes, Gary, 312 Tay-Sachs disease, 411 Teeth, anatomy of, 113 Telemarketing schemes, 62, 431, 517,
522t Tendon, 540 TENS device, 540 Tension, symptoms of, 90, 95 Tertiary-care center, 540 Testable hypothesis, 16, 20, 540 Testimonials, 15, 17, 20, 30, 39, 41, 41t, 42,
53, 57, 60, 61, 83, 131, 134, 197t, 220, 240, 250, 253, 254, 301, 336, 345, 356, 357, 432, 506, 513, 540
Testosterone, 416, 448–450 Teutsch, Dr. Carol, 65 Textbook of Natural Medicine, 144 “T-groups,” 100 Thalidomide, 505, 507 The Secret, 135 Theragran Stress Formula, 200, 201t Therapeutic equivalence (of drugs), 351,
354 Therapeutic Lifestyle Changes (TLC) diet,
311, 311t, 312, 316 Therapeutic touch, 147 Thermography, 167, 172, 229, 331, 540 Thermometers, mercury in, 126 Thimerosal, 290 Third-party payer, 540 Thomas, Adrian, 351 Thomas, Dr. Paul, 199 Thomson, Samuel, 356 Thought field therapy, 105 Thyroid function test, 76 Thyroid hormone, 243 Time magazine, 22, 24, 105–106 “Tired blood,” 55 Tissue salts, 140 TM; see Transcendental meditation (TM) TMJ problems, 121, 125, 127, 540 Tobacco products advertising, 4, 53–54 smokeless, 288 Today’s Health, 234 Tolerable upper intake level (UL), 181 Tolerance (to drug), 540 Tomatis International, 102 Tonometer, 75 Tooth bleaching, 117, 119
Tooth decay, 113–114, 190t Toothbrushes, 116, 118 Toothpastes, 117 Topical use, definition, 540 TOPS (Take Off Pounds Sensibly), 252 Tourette syndrome, 93 Toxic shock syndrome (TSS), 402 Traditional, definition, 540 Traditional Chinese medicine, (TCM)
141–143 Trainers, athletic and personal, 269–270,
270t Tranquilizers, 94 Transcendental meditation (TM), 152–154 Transderm Scop, 372 Transient ischemic attacks (TIAs), 322 Trans-fatty acids, 177, 188, 311, 313, 315,
317, 540 Transillumination, 331 Traveler’s diarrhea, 368 Treadmills, 271 Treatment planning, 540 Tremor, definition, 540 Tretinoin, 383, 385 TRICARE, 481 Triglycerides, 176, 177, 307, 308 Tropicana, Inc., 320 Trudeau, Kevin, 42, 516 Trump, Donald, 62 Tubal ligation, 409 Tubal pregnancy, 540 Tufts University Health & Nutrition Letter,
25t, 30, 241, 279, 281t Tumor registries, 333 “20/20,” (ABC-TV), 128, 167 Twilight sleep, 127 Tylenol; see Acetaminophen Tyrosine, 392
U U.S. Centers for Disease Control and
Prevention (CDC), 74, 78, 114, 156, 268, 405, 412, 412t, 415, 423, 518
U.S. Department of Agriculture (USDA), 179, 182, 187, 193, 207, 246, 518, 535
U.S. Department of Commerce, 488 U.S. Dietary Guidelines; see under Dietary
guidelines U.S. News & World Report, 24, 30, 294,
458–459 U.S. Office of Education, 143, 530 U.S. Postal Service, 9t, 57, 63, 507, 517 enforcement actions, 225, 251 U.S. Preventive Services Task Force, 10,
18, 28t, 75, 76, 186, 206, 289, 324, 412t, 415t, 423
U.S. Surgeon General’s Report on Mental Health, 89
UCR fee, 485, 490 Ultrafast computed tomography, 324 Ultrasound devices, 540 diagnostic uses, 35, 80, 235, 314, 324,
413, 415 and pregnancy, 413 therapeutic use, 426
Ultraviolet light and acne, 386 and cataracts, 391 and skin cancer, 391–392 Unbundling of fees, 497, 540 Uniform Anatomical Gift Act, 443 United Network for Organ Sharing
(UNOS), 442, 443 United Therapeutics Corporation, 319–320 United Sciences of America, 20 United States Pharmacopeia, 354, 512, 540 United States Pharmacopeial Convention,
354, 374t University of California at Berkeley
Wellness Letter, 30, 257, 384, 431 Unnecessary surgery, 81, 540 Upcoding, 540 Urgent care centers, 456 Urinalysis, 75–76 Utilization review, 81, 358, 458, 469t, 492,
493, 495, 536, 540 UV Index, 391
V Vaccination; see Immunizations Vaginal hygiene, 404 Vaginal sponge, 406t, 408 Vaginitis, 405 Vale, Jason, 513 Valerian, 214t Valium, 95 ValueVision, 389 Vaporizers, 366, 367, 430 Varicella-zoster virus, 540 Varicose vein, 540 Vasectomy, 409-410 Vegan, definition, 185, 540 Vegatest, 139 Vegetarian Times, 153 Vegetarianism, 184–185 Verified Internet Pharmacy Practice Sites
program (VIPPS), 358 Vertebra, definition, 540 Vertically integrated system, 540 Very-low-density lipoproteins (VLDL), 308 Veterans Health Administration, 481 Viagra, 417 Viatical settlements, 441–442 Vickery, Dr. Donald M., 287 Vinyl chloride, and cancer, 331 Viral infections, and cancer, 331 Vis Medicatrix Naturae, 135 VISA, regulatory program, 252 Viscera, 540 Vision Dieter, 249 Vision products and services, 421–427 Visual acuity, 422, 423, 427 Visual training, optometric, 104, 426, 540 Vital Foods, Inc., 218 “Vital force,” 135 Vitalism, 135, 540 Vitamin(s), 179; see also Dietary
supplements; Food faddism A, 199 toxicity, 205
Index564
Vitamin(s)—cont’d. advertising, 22, 23, 46, 201t amounts needed; see DRIs B12 and vegetarian diets, 185 B6
for premenstrual syndrome, 403 toxicity, 205–206 biotin, 201t, 389 C (ascorbic acid) and cancer, 204 and diarrhea, 299 and false-negative test for occult
blood, 205 and food processing, 200, 510 intravenous, 228 need for, 201t and smoking, 200 and the common cold, 16t, 204, 367 and tooth erosion, 114 D, 179 and bone health, 415 dangers of excess, 205 and sunlight, 392 E anticoagulant effect, 205, 318 antioxidant effect, 318, 450 and heart disease, 204–205, 318 as moisturizer, 382t therapeutic claims, 204 and exercise, 200, 279 fat-soluble, 179, 205, 206 folic acid; see Folic acid as food additives, 208, 510 food sources, 178t and hair analysis, 124, 172, 219–220, 224 K, 179, 187t losses during food processing, 200, 212t megavitamin therapy, 100–101, 203–206,
536 niacin; see Niacin as placebos, 40 Recommended Dietary Allowances
(RDAs); see RDAs shots, overuse of, 72 storage in body, 201t supplements appropriate use, 206 and children, 246 chiropractors and, 172, 224–225 expenditures for, 198 multilevel companies and, 61–62 “natural vs. synthetic,” 202 needed by vegetarians, 185, 208 pharmacists and, 223–224 and pregnancy, 206, 412 promotion, 54–57, 221–227 reasons for use, 198–199 “stress, ” 200, 202, 201t types of, 199 use by athletes, 6 and weight control, 206, 254 water-soluble, 179, 200, 201t, 205
“Vitamin B17”; see Laetrile “Vitamin B5,” 212t Vitamin Gap Test, National, 221 “Vitamin P”; see Bioflavonoids Voll, Dr. Reinhold, 139 von Peczely, Ignatz, 145 Voodoo, 133 Vulvitis, 405
W Waist-to-hip ratio (WHR), 235–236 Waiting periods (insurance), 469t, 471, 482,
484 Waiver of premium, 469t Wakefield, Dr. Andrew, 19 Walker, Dr. Scott, 103 Walsh, Jerry, 36 Warren, Dr. Robin, 363 Warshak, Steve, 416 Warts, 390 Washington Consumers’ CHECKBOOK, 72 Water bottled, 368, 431 “catalyst-altered,” 209t as nutrient, 176, 178t purifiers, 430–431 testing, 430–431 Wayback Machine, 27 Web, 2.0, 303–304 Weasel words, 4, 48 Web sites judging credibility, 27–30 recommended, 30, 346 Weider, Joe, 284 Weider Health and Fitness, Inc., 60 Weight control, 233–258, 289 basic concepts, 234–237 behavior modification, 255–256 body fat estimations, 235 desirable weights, 235 dietary guideline, 180t diets, questionable, 240–243 difficulty with dieting, 236–237, 239t dubious products and procedures, 6, 58,
59, 248–252, 275–276 eating disorders, 238, 240 exercise and, 236, 238, 254t, 255, 279,
281t FTC ad survey, 252 gadgets and gimmicks, 249–250 government regulatory actions, 250–252,
254 hypnosis for, 251 low-calorie products, 246–248 marketplace, 240 meal-replacement drinks, 241, 247 myths vs. facts, 239t “new lifestyle language,” 255 nonprescription products, 244–246 obesity clinics, 252–253 organizations, 252–254 and portion size, 255–256
prescription drugs, 243 promotions, 59 risks of obesity, 235–236, 288–289 suggestions for, 253, 254–256 surgery, 248 and vitamin supplements, 206, 254 Weight cycling, 237 Weight training; see Strength training Weight Watchers International, 252, 253,
254, 255t Weil, Dr. Andrew, 20, 26, 228–229, 514t Weiss Ratings guides, 478, 479t, 482 Weleda, Inc., 139 Wennberg, Dr. John E., 81 Wheat germ oil, 212t Wheat grass juice, 212t Whirlpool baths, 297 Whitaker, Dr. Julian, 135, 138 White, Dr. Philip L., 240 Wiley, Dr. Harvey W., 506, 507 Williams, J.B., Company, 55 Williams, Dr. Sid E., 163 Winfrey, Oprah, 324 Wisdom tooth extraction, 122 Withdrawal reaction, 540 caffeine, 96, 371 nicotine, 289, 370 Wolfe, Dr. Sidney, 512, 520 Woodrum, Eric, 152 World Chiropractic Alliance, 166, 172 World Health Organization, 78 Worrall, Dr. Russell, 146, 425 Wrinkle removers, 395–396 Wyden, Rep. Ron, 254
X X-ray examinations chiropractic, 166, 172 dental, 121–122 medical; see Medical imaging osteoporosis screening, 415 Xenical, 243
Y Yoga, 134, 268, 532 Yogurt, 178t, 180t, 182, 185, 186, 213, 217,
313, 315, 368, 369 Yohimbe, 216, 416 York Barbell Co., 284 Young, Dr. Frank E., 503 Young, Gregory W., 447 Young, Dr. James Harvey, 38, 133, 198, 507 Young, Robert O., 229 Yo-yo dieting, 540
Z Zen macrobiotic diet, 217 Zenni Optical, 24 Zinc gluconate, 212t Zone diet, 241 Zone therapy; see Reflexology Zygon International, 99
- Cover Page
- Title Page
- Copyright Page
- About the Authors
- To the Reader
- Preface for Instructors
- Contents
- Part One Dynamics of Health Marketplace
- Chapter one Consumer Health Issues
- Misleading Information
- Quackery and Health Fraud
- Problems with Products
- Problems with Services
- Problems with Costs and Access
- Problems with Risk Perception
- The Need for Consumer Protection
- Intelligent Consumer Behavior
- Chapter Two Separating Fact from Fiction
- How Facts Are Determined
- Peer Review
- Trustworthiness of Sources
- Prudent Use of the Internet
- Further Suggestions for Consumers
- Chapter Three Frauds and Quackery
- Definitions
- Scope
- Vulnerability
- Hazards
- Common Misconceptions
- Recognizing Quackery
- Conspiracy Claims
- The Freedom-of-Choice Issue
- Chapter Four Advertising and Other Promotional Activities
- Psychologic Manipulation
- Puffery, Weasel Words, and Half-Truths
- Marketing Outlets
- Professional Advertising
- Marketing by Hospitals
- Prescription Drug Marketing
- Nonprescription Drug Advertising
- Tobacco Promotion
- Food Advertising
- Dietary Supplement Promotion
- Mail-Order Quackery
- Weight-Control Promotions
- Youth and Beauty Aids
- Exercise and Fitness Products
- Program-Length Infomercials
- Multilevel Marketing (MLM)
- Telemarketing Schemes
- Industry Self-Regulation
- Regulatory Agencies
- Part Two Health-Care Approaches
- Chapter Five Science-Based Health Care
- Health-Care Personnel
- Choosing a Physician
- Basic Medical Care
- Surgical Care
- Quality of Medical Care
- The Intelligent Patient
- Chapter Six Mental and Behavioral Help
- Who Should Seek Help?
- Mental Health Practitioners
- Psychologic Methods
- Drug Therapy
- Electroconvulsive Therapy
- Psychosomatic Disorders
- Inpatient Care
- Help for Addictive Behavior
- Selecting Therapist
- Questionable “Self-Help” Products
- Questionable Practices
- Mismanagement of Psychotherapy
- Chapter Seven Dental Care
- Dentists
- Allied Dental Personnel
- Tooth Decay
- Fluoridation
- Periodontal Disease
- Self-Care
- Dental Products
- Dental Restorations
- Endodontics (Root Canal Therapy)
- Orthodontics
- Dentures
- Dental Implants
- Dental X-Ray Procedures
- Questionable Procedures
- Dental Quackery
- Choosing a Dentist
- Chapter Eight The “CAM” Movement
- Classification
- Popularity
- Common Themes
- Homeopatrhy
- Acupuncture and TCM
- Natruropathy
- Natural Hygiene
- Iridology
- Reflexology
- Cranial Therapy
- Aromatherapy
- “Energy Healing”
- Massage Therapy
- Psychic Healing
- Astrology
- Transcendenta l Meditation
- Unscientific Medical Practices
- Supportive Organizations
- “Medical Freedom” Laws
- The NIH Center for Complementa ryand Alternative Medicine (NCCAM)
- Chapter Nine A Close Look at Chiropractic
- Historical Perspective
- Chiropractic Philosophy
- Chiropractic Education
- Research Findings
- Problems for Consumers
- Part Three Nutrition Fitness
- Chapter Ten Basic Nutrition Concepts
- Major Food Components
- Meeting Nutrient Needs
- Food-Group Systems
- Evaluating Your Diet
- Guidelines for Infants and Toddlers
- Vegetarianism
- “Fast Food”
- Nutrients of Special Concern
- Nutrition Labeling
- Trustworthy Information Sources
- Chapter Eleven Nutrition Fads, Fallacies, and Scams
- Food Faddism and Quackery
- Dietary Supplements
- Megavitamin Claims vs Facts
- Appropriate Use of Supplements
- “Organic” Foods
- “Health” and “Natural” Foods
- Raw Foods and “Juicing”
- “Medicinal” Use of Herbal Products
- Macrobiotic Diets
- Dubious Diagnostic Tests
- Promotion of Questionable Nutrition
- Promotional Organizations
- Prominent Individual Promoters
- Chapter Twelve Weight Control
- Basic Concepts
- Eating Disorders
- The U.S. Weight-Loss Marketplace
- Questionable Diets
- Prescription Drugs
- Nonprescription Products
- Low-Calorie Products
- Bariatric Surgery
- Dubious Products and Procedures
- Federal Trade Commission Actions
- Weight-Control Organizations
- Suggestions For Weight Control
- Chapter Thirteen Fitness Concepts, Products, and Services
- Public Perceptions
- Benefits of Exercise
- Types of Exercise
- Components of Fitness
- Starting an Exercise Program
- Personal Trainers
- Sports Medicine Specialists
- Exercise Equipment and Supplies
- Exercise Facilities
- Martial Arts Training
- Children’s Exercise Centers
- Exercise While Traveling
- Exercise and Weight Control
- Nutrition for Athletes
- Anabolic Steroids
- Other “Ergogenic Aids”
- Part Four Personal Health Concerns
- Chapter Fourteen Personal Health and Safety
- Types (Levels) of Prevention
- Health-Promoting Behaviors
- Safety Measures
- Indoor Air Quality
- Risk Perception
- Self-Diagnosis
- Managing Chronic Disease
- Self-Help Advice
- Self-Help Groups
- Questionable Self-Help Devices
- Internet Considerations
- Chapter Fifteen Cardiovascular Disease
- Significance of Cardiovascular Disease
- Risk Factors for Coronary Heart Disease
- Blood Lipid Levels
- Cholesterol Guidelines
- Dietary Modification
- Lipid-Lowering Drugs
- Preventive Use of Aspirin
- Questionable Preventive Measures
- High Blood Pressure
- Heart Attacks
- Diagnostic Tests
- Surgery to Restore Blood Flow
- Cardiac Rehabilitation Programs
- Chapter Sixteen Cancer
- Avoidable Causes of Cancer
- Preventive Measures
- Diagnosis
- Prognosis
- Evidence-Based Treatment Methods
- Diet and Cancer Prevention
- Susceptibility to Cancer Quackery
- Questionable Methods
- Promotion of Questionable Methods
- Trustworthy Information Sources
- Treatment Guidelines
- Consumer Protection Laws
- Part Five Other Products and Services
- Chapter Seventeen Drug Products
- Medication Types
- Pharmacists
- Prescription Drugs
- Generic vs Brand-Name Drugs
- Drug Interactions
- Drug Recalls
- Counterfeit drugs
- Internet Pharmacy Sales
- Over-the-Counter Drugs
- External Analgesics
- Internal Analgesics
- Antacids and Other Heartburn Remedies
- Antimicrobial Drug Products
- Cough and Cold Remedies
- Sore-Throat Products
- Ophthalmic Products
- Diarrhea Remedies
- Anti-Hemorrhoidals
- Laxatives
- Smoking Deterrents
- Stimulants for Fatigue
- Sleep Aids
- Motion Sickness Remedies
- Iron-Containing Products
- Home Medicine Cabinet
- Prudent Use of Medication
- Chapter Eighteen Skin Care and Image Enhancement
- Cosmetic Regulation
- Soaps and Cleansers
- Moisturizers
- Questionable Claims
- Wrinkles and Age Spots
- Fade Creams
- Antiperspirants and Deodorants
- Acne Care
- Head Hair and Scalp Care
- Hair Loss
- Tattoos and Permanent Makeup
- Body Piercing
- Treatment of Common Foot Problems
- Poison Ivy
- Insect Repellents
- Sun Protection
- Camouflage Cosmetics
- Cosmetic Procedures
- Bogus Breast And Penis Enlargement Claims
- Chapter Nineteen Sexual and Reproductive Health
- Menstrual Products
- Menstrual Problems
- Vaginal Hygiene
- Vaginitis
- “Jock Itch”
- Sexually Transmitted Diseases
- Contraception
- Voluntary Abortions
- Infertility
- Genetic Testing and Prenatal Counseling
- Pregnancy and Delivery
- Cord Blood Banking
- Infant Feeding
- Treatment of Menopausal Symptoms
- Alleged Sex Enhancers
- Genuine Help for Erectile Dysfunction
- Chapter Twenty Health Devices
- Medical-Device Regulation
- Vision Products and Services
- Hearing Aids
- Humidifiers and Vaporizers
- Personal Emergency Response Systems
- Latex Allergy
- Dubious Water Purifier Promotions
- Spinal Decompression Machines
- Quack Devices
- Consumer Strategy
- Chapter Twenty-One Coping with Death
- Advance Directives
- Viatical Settlements
- Donations of Organs and Tissues
- Hospice Care
- Euthanasia and Assisted Suicide
- Reasons for an Autopsy
- Body Disposition
- Coping with Grief
- Life-Extension/Anti-Aging Quackery
- Chapter Twenty-Two Health-Care Facilities
- Accreditation
- Outpatient Medical Facilities
- Hospitals
- Home Care Services
- Assisted Living Facilities
- Nursing Homes
- Continuing Care Retirement Communities
- Part Six Protection of the Consumer
- Chapter Twenty-Three Health Insurance
- Background
- Comprehensive Medical Insurance
- Contract Provisions
- Types of Plans
- Consumer-Directed Expense Accounts
- “Concierge Medicine”
- Indemnity vs Managed Care
- Loss Ratios
- Choosing a Plan
- Medicare
- Medicaid
- Other Government-Sponsored Programs
- Long-Term–Care Insurance
- Dental Insurance
- Collection of Insurance Benefits
- Disability Insurance
- Chapter Twenty-Four Health-Care Financing
- Health-Care Costs
- Cost-Control Methods
- Insurance Fraud and Abuse
- National Health Insurance (NHI)
- Chapter Twenty-Five Consumer Laws, Agencies, and Strategies
- U.S. Food and Drug Administration
- Federal Trade Commission
- U.S. Postal Service
- Other Federal Agencies
- State and Local Agencies
- Physician Regulation
- Nongovernmental Organizations
- Consumer Action
- Appendix Trustworthy Sources of Information
- Federal Government Agencies
- Nongovernmental Organizations
- Glossary
- Index