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Epidemiology in Evidence-Based Policy: Translating Evidence into Policy

Michel A. Ibrahim, MD Johns Hopkins University

!  Section A: Introductory Remarks

!  Section B: Settings of Policy Making

!  Section C: Influence of Certain Groups

!  Section D: Conclusion

Four Sections

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Introductory Remarks

Section A

A wide gap still exists “between the work of the student of the science of nutrition and that of the expert in the art of feeding. … applies … in many domains of the field of medicine.” “The scientific man has been too exclusively scientific and the practical man too exclusively practical and the result has been unfortunate for both.”

—JAMA, April 18, 2012, Vol. 307, No. 15

Research and Practice: JAMA 100 Years Ago (1912)

“Unfortunately advances in scientific medicine are frequently heralded as being of much more value and importance than they can possibly prove to be.” “ … the public loses confidence in medical science after finding that some of these heralded improvements accomplish far less than was promised.”

—JAMA, April 18, 2012, Vol. 307, No. 15

Exaggerating Medical Advances: JAMA 100 Years Ago (1912)

Defining Evidence

!  Basic or animal research

!  Clinical observations

!  Observational studies: descriptive !  Correlation/ecologic !  Clinical case reports/series !  Cross-sectional

!  Observational studies: analytic !  Case-control (rare disease) !  Cohort (rare exposure)

!  Randomized controlled trials (RCTs)

!  Systematic reviews/meta-analyses

!  Systematic reviews/meta-analyses of large RCTs

Source: adapted from (March 16, 2011). JAMA, Vol. 305, No. 11. 6

Settings of Policy Making

Section B

!  Laws developed by legislative bodies (Congress of United States, city council)

!  Actions developed/adopted by regulatory agencies (EPA, FDA)

!  Decisions made by the courts (especially for class-action suits)

!  Guidelines developed by expert panels (USPSTF)

!  Actions taken by health departments, institutions, corporations

!  Decisions made in a clinical setting

Settings of Policy Making

1. Legislative and Regulatory

!  Smoking bans/electronic cigarette

!  Graphic warnings/plain packaging

!  Trans fat ban in NYC restaurants

!  Compulsory HPV vaccination

!  Medicare and Medicaid

!  OTC sale of the morning-after pill

!  Taxing sugary drinks

!  Banning oversized sugary drinks

Cigarettes

FDA

UK Proposal !  Plain packaging

!  Evidence supports benefit

“Three justifications … the risk of passive smoke … the pollution caused by cigarette butts, and … risks to children from seeing smoking in public.” “Our analysis of the evidence for these claims found it far from definitive and in some cases weak.” “ … the impetus [to impose such bans] is the imperative to denormalize smoking as part of a broader public health campaign to reduce tobacco- related illness and death.” Question: is it effective to use limited evidence for policy?

Banning Smoking in Parks and on Beaches

Source: Bayer R, Bachyniski KE. Health Affairs 2013;32(7):1291-1298. 11

“Electronic cigarettes (e-cigarettes or electronic nicotine delivery systems) heat a nicotine solution to generate vapor that is inhaled, without the combustion of tobacco and its toxic constituents. Use of e-cigarettes is increasing in the United States and around the world.” “Current smokers in the United States report an 11.4% prevalence of ever use of e-cigarettes.” … “The FDA will need to make a number of regulatory decisions about product safety that could have major effects on public health and will face many challenges.” Questions about potential “benefits” and potential “harms” to the individual and to the population require answers

The Electronic Cigarette: Next Challenge

Source: Benowitz NL, Goniewicz ML. (Published online July 15, 2013). JAMA. 12

E-cigarette Nic Fit by Van Smith, April 9, 2014 (City Paper)

Parts of an E- Cigarette Structure and Substances that May Be Found in the Vapor

Source: JAMA 2014, 311(2): 212 14

Sugary Drinks

Source: (2010). BMJ, 341:bmj.c7264 15

!  The pill has been available without prescription to women 17 and older

!  The FDA wanted to lower age to 15 (April, 2013)

!  A federal judge strikes down age limit !  Should be available without prescription to all ages

!  FDA intends to appeal the decision

!  Government backs down and accepts the court’s ruling (June, 2013)

Morning-After Pill

!  Compensation for patients with breast implants (class-action suit)

!  Compensation for patients exposed to asbestos (class-action suit)

!  Rejection of vaccine connection to autism

2. The Courts

!  The consensus conference of the National Institutes of Health (NIH)

!  The United States Preventive Services Task Force (USPSTF)

!  The IOM expert committees

3. Expert Panels

Source: (2009). Ann Intern Med, 151:716–726. 19

Source: (2009). Ann Intern Med, 151:716–726. 20

!  Fluoridating community water supply

!  Implementing a needle exchange program for drug addicts

!  Enforcing safe lead levels in children

!  Mandating seasonal and H1N1 vaccinations of NY healthcare workers

4. Health Departments

!  Smoke-free environment in hospitals and universities

!  Offering abortion services in hospitals

!  Offering physical activity programs to company employees

!  Offering incentives to reduce obesity

!  Offering financial incentives to non-smokers

5. Institutions and Corporations

!  Lumpectomy or radical procedure for this woman with this type of breast cancer

!  Mammography for this 42-year-old woman

!  Removing a cancerous prostate in this 70-year-old man or electing watchful waiting

!  PSA screening for this 55-year-old man

6. The One-on-One Clinical Decisions

Influence of Certain Groups

Section C

1. Influence of Practitioners, Populations

!  Practitioners’ behavior

!  Practitioners as role models

!  Population perceptions of threat

!  The cost/benefit ratio

!  Political will and societal values

!  Surgeon General Koop put the public at ease about condoms and HIV/AIDS

!  Congressional testimony of Rock Hudson and Magic Johnson promoted research funding for HIV/AIDS

!  Nancy Reagan’s choice of radical mastectomy rather than lumpectomy

!  Angelina Jolie’s public disclosure of prophylactic mastectomy

!  Michael Douglas’s throat cancer from a virus transmitted during oral sex

2. Influence of Celebrities

!  Women with similar cancers opted for radical mastectomies

!  But this lasted for only about six months

!  Lumpectomies became preferred again

Impact of Nancy Reagan’s Choice

4 Image source: Wikipedia Commons.

!  The publicity heightened awareness—not knowledge—about breast cancer risk

!  “While three of four Americans were aware of Angelina Jolie’s double mastectomy, fewer than 10% of respondents had the information necessary to accurately interpret Ms. Jolie’s risk of developing cancer relative to a woman unaffected by the BRCA gene mutation”

Impact of Angelina Jolie’s Story

5 Source: doi:10.1038/gim.2013.181

Determinants of Policy

Conclusion

Section D

1.  Does the evidence match the policy?

2.  Is evidence alone sufficient for policy?

3.  Is it policy-based evidence or evidence-based policy?

4.  What about uncertainty of evidence?

5.  What makes it epidemiologic?

Consider these Five Questions

!  A disconnect

!  A good balance

1. Does the Evidence Match the Policy?

Evidence Outweighs Policy

Policy Outweighs Evidence

Policy Commensurate with Evidence

“Scientific research is an extremely valuable tool for informing health policy decisions … does not mean that democratic and human rights considerations can or should be cast aside, hence there is no such thing as evidence based policy, only ‘evidence informed’ policy.”

2. Is Evidence Alone Sufficient for Policy?

Source: Humphreys K, Piot P. (27 February 2012). BMJ. 7

!  Reviewing selected evidence to justify a desired (and perhaps an already made) policy = policy-based evidence

!  In contrast, reviewing all evidence to inform an appropriate policy = evidence-based policy

3. Is it Policy-Based Evidence or Evidence-Based Policy?

“All scientific work is incomplete—whether it be observational or experimental. “All scientific work is liable to be upset or modified by advancing knowledge. “That does not confer upon us a freedom to ignore the knowledge we already have, or to postpone the action that it appears to demand at a given time. “Who knows, asked Robert Browning, but the world may end tonight? True, but on available evidence most of us make ready to commute on the 8:30 next day.”

4. What about Uncertainty of Evidence?

Source: Bradford Hill: JAMA, March 16, 2011, Vol. 305, No. 11 9

!  We are good at acquiring, analyzing, and assessing the evidence

!  We emphasize a state of health as the outcome variable

!  We make the population our focus

5. What Makes it Epidemiologic?

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