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Medicalization, Markets and Consumers Author(s): Peter Conrad and Valerie Leiter Source: Journal of Health and Social Behavior, Vol. 45, Extra Issue: Health and Health Care in the United States: Origins and Dynamics (2004), pp. 158-176 Published by: American Sociological Association Stable URL: http://www.jstor.org/stable/3653830 Accessed: 30-12-2016 21:19 UTC

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Medicalization, Markets and Consumers*

PETER CONRAD

Brandeis University

VALERIE LEITER

Simmons College

Journal of Health and Social Behavior 2004, Vol 45 (Extra Issue): 158-176

This paper examines the impact of changes in the medical marketplace on med- icalization in U S. society. Using four cases (Viagra, Paxil, human growth hor- mone and in vitro fertilization), we focus on two aspects of the changing med- ical marketplace: the role of direct-to-consumer advertising of prescription drugs and the emergence ofprivate medical markets. We demonstrate how con- sumers and pharmaceutical corporations contribute to medicalization, with physicians, insurance coverage, and changes in regulatory practices playing facilitating roles. In some cases, insurers attempt to counteract medicalization by restricting access. We distinguish mediated and private medical markets, each characterized by differing relationships with corporations, insurers, con- sumers, and physicians. In the changing medical environment, with medical markets as intervening factors, corporations and insurers are becoming more significant determinants in the medicalization process.

Over the past three decades there has been a marked increase in the medicalization of soci-

ety (Zola 1972; Conrad and Schneider 1992; Barsky and Boros 1995; Riska 2003). Medicalization occurs when previously non- medical problems are defined and treated as medical problems, usually in terms of illnesses or disorders. While medicalization can be bi-

directional, there is strong evidence for increases in medicalization. This growth of medical jurisdiction is "one of the most potent transformations of the last half of the twentieth

century in the West" (Clarke et al. 2003:161). In this same period, the institution of medicine has undergone major changes in its social organization, with the advent of managed care, the declining power of the medical profession, and a rise in consumer advocacy and account- ability (Starr 1982; McKinlay and Marceau 2001). As medicine has changed, has the

process of medicalization been transformed as well? In an ambitious paper, Clarke and her colleagues (2003) argue that the technoscien- tific changes in medicine have expanded med- icine's boundaries even further into biomed-

icalization, a wide ranging process that includes complex and multi-sited transforma- tions in medical knowledge, technology, sur- veillance, and bodies. Our task here is narrow- er and more focused. We ask, how have changes in the institution of medicine affected the process of medicalization? Have the shift- ing power dynamics in medicine altered med- icalization? What are current engines driving increased medicalization? What factors con-

strain its growth? Most previous analyses of medicalization

focused on the influence of physicians, lay reformers, or medical and scientific discover- ies. This paper departs from that tack, focusing instead on the creation of markets and the

impact of these markets on medicalization. Although the players are similar, the emphasis is different. Given the changing medical scene, important arenas of medicalization are moving from professional to market domains.

In this paper we examine the impact of

* Our thanks to Phil Brown, Emily Kolker, Stefan Timmermans, anonymous reviewers, and the editors for comments on a earlier version of this paper. Send correspondence to: Peter Conrad, Department of Sociology, MS-71, Brandeis University, Waltham, MA 02454-9110. Email: [email protected].

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MEDICALIZATION, MARKETS AND CONSUMERS 159

changes in the medical marketplace on the increasing medicalization of society. We first review the extant general explanations for the increased medicalization, setting these in the context of recent changes in the medical sys- tem and expanding medical knowledge. The core of the paper focuses on two aspects of the changing medical market place: Direct-to-con- sumer advertising of prescription drugs in insurance mediated medical markets and the

emergence of new private medical markets. The final section links these two aspects of the changing medical marketplace to medicaliza- tion and to consumers' access to health care.

AGENTS OF MEDICALIZATION

There are numerous broad social factors that

have encouraged or abetted medicalization, including the diminution of religion; an abid- ing faith in science, rationality, and progress; an increased reliance on experts; and a general humanitarian trend in Western societies

(Conrad 1992:213). These factors, rather than being explanatory, set the context in which medicalization occurs.

Sociologists and other analysts have identi- fied direct factors that facilitate medicaliza-

tion. Foremost among these, on the "supply" side is the prestige and power of the medical profession. It is well known that the medical profession gained great influence and authori- ty in the first three quarters of the twentieth century, attaining both a professional domi- nance (Freidson 1970) and cultural authority (Starr 1982). Professional dominance and medical monopolization gave medicine juris- diction over virtually anything to which the label "health" or "illness" could be attached

(Freidson 1970). Studies of problems ranging from childbirth (Wertz and Wertz 1989) to child abuse (Pfohl 1977) to the rise of behav- ioral pediatrics (Halpern 1990) all purport some kind of intra-professional explanation for an increase in medicalization. It should be

noted, however, that sometimes problems have been thrust onto the medical profession, which may be resisted (e.g., Kurz 1987).

On the "demand" side of medicalization, there has been growth in consumer demand for medical solutions. Barsky and Borus (1995) suggest that the public's tolerance for mild symptoms and benign problems has decreased, spurring a "progressive medicalization of

physical distress in which uncomfortable body states and isolated symptoms are reclassified as diseases . . ." (p. 1931). Conrad and Potter (2000) note that the expansion of attention deficit hyperactivity disorder (ADHD) from a childhood to an adult disorder typically involves patients asking doctors for a diagnosis and medication. Patients have become more

knowledgeable, demanding, and critical of medical care (Williams and Calnan 1996). The Internet has facilitated consumer involvement

by offering easily accessible health-related information and providing a method for com- munication among like-minded individuals (Hardey 2001). Organized lay interests and advocates frequently play a significant role in medicalization, such as in the creation and institutionalization (in DSM-III) of the diagno- sis post-traumatic stress disorder (Scott 1990). However, advocates for sexual addiction (Levine and Troiden 1988) and multiple chem- ical sensitivity disorder (Kroll-Smith and Floyd 1997) have not had such success.

New medical knowledge can also contribute to medicalization, especially in terms of etiol- ogy and treatment. The Human Genome Project and the attendant rise of genetics is one major potential source of increased medical- ization. If a problem can be shown to have a genetic component it becomes a good candi- date for (new or renewed) medical definitions (Conrad 2000). Similarly, the development of new medical treatments with pharmaceutical drugs can be an important factor in the med- icalization of particular problems, such as the impact of Ritalin on ADHD or estrogen replacement therapy on menopause. However, it is important to emphasize that new biomed- ical knowledge or interventions alone cannot engender medicalization. Etiology or treat- ment may be a central component of a claim to medicalization, but those claims must be championed by supporters or promoters of a diagnosis, be they physicians, patients, lay advocates, or commercial entities such as drug companies.

Many of the key medicalization studies were completed over a decade ago. Important changes have occurred in health care since then, especially the increased corporatization of health care (Light 2000). Light (1993) has proposed the concept "countervailing powers" to describe the changing balance of power among the medical profession and related social institutions. In American society, profes-

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160 JOURNAL OF HEALTH AND SOCIAL BEHAVIOR

sional medicine historically dominated health care, but we now see "buyers" (e.g., corpora- tions that pay for employees' health insurance); "providers" (e.g., physicians, hospitals, HMOs); "payers" (e.g., insurance companies, governments); and "consumers" (e.g., patients, advocacy groups) all vying for power and influence over medical care. The growing influence of the biotechnology industry (espe- cially the pharmaceutical and genomics indus- tries), has increased the complexity of the "the medical-industrial complex" (Relman 1980; Clarke et al. 2003). In this paper we explore how the develop-

ment and promotion of new technologies, con- sumer demand, and the emergence of new medical markets have facilitated new areas of

medicalization. Using the cases of Viagra, Paxil, human growth hormone, and in vitro fertilization (IVF) as illustrations, we contend that, in the climate of increased corporatization of health care and decreased public regulation, the creation or expansion of new medical mar- kets are a significant force toward medicaliza- tion.

ON MEDICAL MARKETS

Until the last decade or so, sociologists rarely examined medicine as any kind of mar- ketplace. But it is becoming clear that, with the development of managed care, corporatized medicine, and the rise of the biotechnology industry, medical markets are increasingly important in the analysis of health care.

When medical products, services, or treat- ments are promoted to consumers to improve their health, appearance, or well-being, we see the development of medical markets. The idea of medical markets has been described as a

"theoretical anomaly" (Light 2000:395), as medical markets often do not meet many of the elements in classical definitions of a competi- tive marketplace. In a free market, consumers are supposed to be informed, appreciate differ- ences in quality, and have bargaining power and free choice about buying, but these assumptions are often violated in health care markets (Lown 2000). Asymmetry of informa- tion and "uncertainty in the definition, recog- nition, and diagnosis of disease states" (Montagne 1992:401) in particular distinguish medical markets from other "consumer" mar- kets.

There are, however, some medical markets that do resemble classic consumer markets, in which goods and services are exchanged as commodities. Over the last few decades, the "medical-industrial complex" has grown, "mainly as a response to the entrepreneurial opportunities afforded by the expansion of health insurance coverage offering indemnifi- cation through Medicare and employment- based plans" (Relman 1991:856). In short, the existence of third party funding has encour- aged certain types of medical markets because of available insurance, although this has been partly restrained by managed care.

The use of advertising, the development of specific medical markets, and the standardiza- tion of medical services into product lines have contributed to an increased commodification

of medical goods and services. Advertising of health care has become more commonplace (Dyer 1997), and new medical markets have emerged, particularly for specialty services. Imershein and Estes (1996) argue that medical services are increasingly organized into prod- uct lines (with attached payment schemes), consistent with a market-based approach to exchange. Cosmetic surgery is the most com- modified of medical specialties, offering treat- ments that are often not covered by insurance, such as liposuction and breast augmentation (Sullivan 2001). Cosmetic surgeons advertise to stimulate demand for their services, for which patients pay cash (or borrow from finance companies that partner with cosmetic surgeons, much like purchasing a car).

In the last five years, a loosened regulatory environment has given pharmaceutical and biotechnology companies more freedom in advertising their wares, both to physicians and consumers. The Federal Drug Administration Modernization Act of 1997 made several

changes that have facilitated medicalization. Most relevant to our analysis, the act loosened the restrictions placed on the kind of informa- tion that pharmaceutical companies could share with physicians regarding "off-label" uses of their drugs, and subsequently, the information that must be included in direct-to- consumer advertisements.

The constant development of new technolo- gies, treatments, and drugs sparks consumer interest in obtaining access to these new med- ical goods and services, and advertising can further increase consumer demand. Consumers

may gain access to these goods and services

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MEDICALIZATION, MARKETS AND CONSUMERS 161

through one of two kinds of markets: mediated markets and private markets. In mediated markets, there is an indirect

relationship between consumers, on the demand side, and medical producers or providers, on the supply side, with third party payers occupying an intervening role. Third party payers (typically private or public insur- ers) intervene in the exchange relationship between consumers and providers or producers in two ways: by defining what is "medically necessary" and then paying for only those goods and services that they have deemed medically necessary. The degree of control exercised by third party payers varies, depend- ing upon the level of "management" of care being exercised. Managed care regulations dampen consumer demand for medical goods and services, particularly regarding access to new technologies (Mechanic 2002), reducing consumers' ability to purchase medical solu- tions to perceived health problems. Consumers who want medical goods or ser-

vices but cannot obtain them through mediated markets may turn instead to private markets, depending upon the cost of the goods or ser- vices and consumers' financial resources. In

private markets, there is a more direct econom- ic relationship between consumers and med- ical producers or providers: If consumers can afford a treatment, they can most likely find a medical provider who will provide it for "cash." Again, cosmetic surgery is one exam- ple of private medical markets. In private med- ical markets, care is provided to consumers who can afford to pay for it, and other potential consumers are excluded.

In our analysis, we examine how four rela- tively recent medical developments are distrib- uted through mediated and private markets, and how distribution through these two types of markets is related to medicalization.

Specifically, we look at (1) the creation of demand for new medical products in mediated medical markets; and (2) the development of private medical markets.

CREATING AND CAPITALIZING ON MEDICAL MARKETS

In 1999, the pharmaceutical industry was the most profitable industry in the United States, with an 18.6 percent return on revenues (Angell 2000). It is among the fastest growing

components of health care, rising at 15 percent a year, now constituting 8 percent of health care spending (Angell 2000). In the same year, Americans purchased 2.5 billion prescriptions, averaging nine per American, for a total of $125 billion (Cohen et al. 2001). The pharma- ceutical industry has a long history of market- ing prescription medication directly to doctors through "detailing," direct mail, ads in medical journals, gifts, travel subsidies, and sponsoring events (Wanzana 2000).

While some direct-to-consumer advertising existed in the United States for over two

decades (Pines 1999), recently the pharmaceu- tical industry has substantially increased its investment in targeting consumers directly. Annual spending on direct-to-consumer adver- tising for prescription drugs tripled between 1996 and 2000; it is only 15 percent of all mar- keting, but by far the fastest rising segment. Much of this increase has been in television

advertising after the Federal Drug Administration Modernization Act of 1997

made it easier to advertise drugs to the general public (Lyles 2002). This change allowed broadcast ads to name both the disorder and

the drug so long as they also contain limited risk and benefit information, making televi- sion drug advertising more feasible and more attractive to the pharmaceutical industry. Spending specifically on television advertising increased six-fold between 1996 and 2000, to $1.5 billion dollars (Rosenthal et al. 2002).

The pharmaceutical companies claim that direct-to-consumer advertising has an educa- tional function that creates better informed

consumers, encouraging consumers to consult their physicians about underdiagnosed symp- toms and treatment options, and enabling patients to make better choices (Bonaccorso and Sturchio 2002; Lyles 2002). Critics are concerned that such advertising leads to physi- cians wasting time during medical visits explaining why a treatment is not appropriate, can lead to unnecessary use of medical resources and excessive profits for drug com- panies, and medicalize normal conditions (Mintzes 2002; Rosenthal et al. 2002). The vast majority of direct-to-consumer advertis- ing focuses on a limited number of drugs; in 2000, 20 drugs accounted for 60 percent of direct-to-consumer advertising. These include a wide range of drugs, including antidepres- sants, antihistamines, antihyperliplidemics, and anti-inflammatory agents.

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162 JOURNAL OF HEALTH AND SOCIAL BEHAVIOR

One aspect of direct-to-consumer advertis- ing that has not been discussed is its impact on expanding the medicalization of human prob- lems. So-called "consumer education cam-

paigns" are used to introduce products, bring- ing new people into a market by creating a pre- viously unrecognized demand for the product (Applbaum 2000). The direct-to-consumer advertising may well shape the way the public conceptualizes problems and it may increase consumer demand for medical solutions. At

least two of the top 20 drugs promoted with direct-to-consumer advertising (see Rosenthal et al. 2002) have significant implications for medicalization: Viagra (ranked 6) and Paxil (ranked 4).

Viagra and Erectile Dysfunction

Male impotence has been a medical problem for many years. There is some evidence of medicalization in the Victorian era (Mumford 1992), although its dominant framing through- out much of the 20th century appears to have been as a psychogenic problem. In the 1990s, the problem became redefined as sexual dys- function and its treatment was promoted by urologists, the medical technology industry, mass media, and entrepreneurs (Teifer 1994). A consensus conference in 1992 officially renamed the problem "erectile dysfunction" (National Institutes on Health Consensus Development Panel on Impotence 1993), high- lighting its nature as a biogenic rather than psychogenic problem. Available treatments such a penile surgery, implants, and injections were medical, although their results were mixed (Teifer 1994).

In March 1998, the Federal Drug Administration (FDA) approved Viagra (silde- nafil citrate) as a treatment for erectile dys- function. Intended primarily for the use of older men with erectile problems and for erec- tile dysfunction associated with prostate can- cer, diabetes, or other medical problems (Loe 2001), Viagra was the first non-invasive med- ical treatment for male sexual dysfunction. The medication operates by increasing the blood flow to the penis, allowing a man to achieve and sustain an erection when sexually aroused. Ingested orally, it takes effect in 30 to 60 min- utes and can last from 4 to 6 hours.

A demand for a drug for erectile problems surely existed before Pfizer began advertising

Viagra. Estimates of the prevalence of erectile dysfunction range from 10 to 20 million men (Fabbri et al. 1997) to suggestions that up to half all American men are "sexually dysfunc- tional" (Laumann et al. 1999). Erectile diffi- culties affected not only men but their partners as well, and they were linked to powerful issues surrounding masculinity and sexual per- formance, making "erectile dysfunction cen- tral to masculine self esteem" (Teifer 1994:370). Pfizer Pharmaceuticals, the manu- facturer of Viagra, tapped into this vast poten- tial market and shaped it by promoting sexual difficulties as a medical problem and Viagra as the solution.

With an aging population, a high prevalence of sexual dysfunction, and an even larger con- cern with sexual performance insecurity, the potential American market was huge, with an even more extensive worldwide market. The

initial advertising for Viagra was minimal (Carpiano 2001), but Pfizer soon marketed Viagra aggressively both to physicians and the general public. The direct-to-consumer ads included spokesmen as mainstream as former Senator and Presidential candidate Bob Dole, well recognized athletes, and ordinary people, all testifying to the wonders of Viagra and how it has changed an important part of their lives. One typical ad showed baseball star Rafael Palmiero with the words "I take batting prac- tice," indicating both that vigorous athletes can take Viagra and that even stars might need some help in performance. Viagra became an official sponsor of major league baseball, as well as sponsoring both the Viagra car in the NASCAR circuit and Spanish language soccer broadcasts. Thus advertising expanded the market to include virtually any man who might consider himself as having some type of erec- tile or sexual problems.

Viagra sales were phenomenal. Physicians wrote 2.9 million prescriptions in the first three months of its availability; in the first year alone, over three million men were treated with Viagra, translating into $1.5 billion in sales (Carpiano 2001). Perhaps 200,000 prescrip- tions for Viagra are written weekly (Tuller 2002), with untold more Viagra sold through the Internet and other outlets. In 2000, Viagra was ranked 6th in terms of both direct-to-con-

sumer spending and sales, with a total of $89.5 million spent and $809 million in sales, and a 17 percent increase in utilization from 1999 to 2000 (NIHCM 2001).

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MEDICALIZATION, MARKETS AND CONSUMERS 163

Viagra was a factor in the diagnostic expan- sion of sexual dysfunction and the increased medicalization of sexual performance (cf. Conrad and Potter 2000). Prior to Viagra, med- ical treatment was largely limited to major dys- functions (e.g., as from prostate surgery). Now it included mild dysfunctions (e.g., occasional erectile problems) and could be used as an enhancement (Conrad and Potter 2004), offer- ing a "jump start" or extra strength for sexual encounters (Loe 2001). Viagra is not an inexpensive medication: It

costs about $10 per pill. Within months of the FDA's approval of the drug, many large insur- ers (e.g., Kaiser Permanente and Aetna U.S. Healthcare) decided that they would not cover the drug, except at an extra cost to employers or individuals, while others did cover the drug (e.g., Blue Cross/Blue Shield plans in Indiana and California, Harvard Pilgrim Health Care, and the Defense Department's health plan). However, many insurers who currently cover the drug limit the number of pills per month. For example, Tufts Health Plan (2002) covers four tablets every 30 days, and Blue Cross and Blue Shield of Texas (2003) covers eight tablets every 30 days. In Britain, however, the National Health Service covers Viagra only for sexual dysfunction related to conditions such as diabetes, prostate cancer, and renal failure (Michael Bury, University of London-Royal Holloway, personal communication). The health insurance industry was involved

in the debate over whether "sexual dysfunc- tion" was a medical necessity and whether Viagra should be covered by health insurance, resulting in mixed insurance coverage for Viagra. In this case, the insurance industry attempted to counteract increased medicaliza- tion of male sexual dysfunction by restricting access to Viagra. However, individuals with a physician's prescription could of course pur- chase the drug on their own or through a range of Internet sites.

One important social benefit from the popu- larity and widespread use of Viagra is a reduc- tion of the stigma of sexual dysfunction. Seeing ads for Viagra in so many mainstream locations and making Viagra part of everyday discussions has made sexual dysfunction and its treatment appear conventional and com- monplace. This has most likely also increased the market for Viagra, since it would be less stigmatizing to inquire about and use it. The success of Viagra and the subsequent

expansion of the concept of male sexual dys- function has prompted other companies to enter and expand this market, including phar- maceutical companies either developing new drugs to compete with Viagra (Tuller 2002) or seeking a "female Viagra" (Moynihan 2003; Hartley 2003). Given the aging baby boomers and the entrepreneurial pharmaceutical indus- try's increased promotion of "lifestyle" drugs marketed directly to consumers (Mamo and Fishman 2001), the medicalization of sexual dysfunction is likely to continue to expand, at least for the foreseeable future.

Paxil and Social Anxiety Disorders

When the FDA approved Paxil (paroxetine hydrochloride) for the treatment of depression in 1996, Paxil followed Prozac and several other selective serotonin reuptake inhibitors (SSRIs) into an already saturated market for the treatment of depression. The manufacturer of Paxil (now called GlaxoSmithKline) responded to the saturated "depression mar- ket" by requesting FDA approval for addition- al applications of Paxil, specializing instead in the "anxiety market," including panic disorder and obsessive compulsive disorder at first, and then social anxiety disorder (SAD) and gener- alized anxiety disorder (GAD). Paxil's applica- tion to SAD and GAD has contributed to the

medicalization of emotions, expanding med- ical jurisdiction over emotions such as worry and shyness.

SAD and GAD were fairly obscure diag- noses when they were added to the American Psychiatric Association's Diagnostic and Statistical Manual (DSM) in 1980. According to the DSM-IV, SAD (or "social phobia") is a persistent and extreme "fear of social and per- formance situations in which embarrassment

may occur" (American Psychiatric Association 1994:411) and GAD involves chronic, exces- sive anxiety and worry (lasting at least six months), involving multiple symptoms (American Psychiatric Association 1994: 435-36). Both conditions are defined as being associated with significant distress and impair- ment in functioning. Horwitz (2002) notes how small changes in wording of criteria for SAD resulted in a tremendous growth in its estimat- ed prevalence (and potential market).

Marketing diseases and then selling drugs to treat those diseases is now common in the

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164 JOURNAL OF HEALTH AND SOCIAL BEHAVIOR

"post-Prozac" era. Since the FDA approved the use of Paxil for SAD in 1999 and for GAD in

2001, GlaxoSmithKline has spent millions of dollars to raise the public visibility of SAD and GAD, by sponsoring well-choreographed dis- ease awareness campaigns. The pharmaceuti- cal company's savvy approach to marketing SAD and GAD, which relied upon a mixture of "expert" and patient voices, simultaneously gave the conditions diagnostic validity and cre- ated the perception that it could happen to any- one (Koerner 2002). Soon after the FDA approved the use of Paxil for SAD, Cohn and Wolfe (a public relations firm that was work- ing for what was then SmithKline) began putting up posters at bus stops with the slogan, "Imagine Being Allergic to People." Later in 1999, a series of ads featured "Paxil's efficacy in helping SAD sufferers brave dinner parties and public speaking" (Koerner 2002:61). Barry Brand, Paxil's product director, said, "Every marketer's dream is to find an uniden- tified or unknown market and develop it. That's what we were able to do with social anx-

iety disorder" (Vedantam 2001). Through media campaigns, GlaxoSmithKline

redefined SAD and GAD, paradoxically, as both common (reducing the stigma associated with having a "mental illness") and abnormal (subject to medical intervention, in the form of Paxil). Prevalence estimates of both SAD and GAD range widely. For example, estimates of the prevalence of SAD range from 3 percent to 13 percent (American Psychiatric Association 1994:414), with the National Institute of Mental Health estimating that 3.7 percent of the U.S. population has SAD (Vedantam 2001). Higher prevalence rates are associated with less stringent application of the DSM- specified criteria for these conditions.' Horwitz (2002) argues that, "Because commu- nity studies consider all symptoms, whether internal or not, expectable or not, deviant or not, as signs of disorder, they inevitably over- estimate the prevalence of mental disorder in the community" (p.105). Likewise, the disease awareness campaign focused on individuals' feelings in social situations likely to evoke fear in many people, especially public speaking, and offered consumers symptom-based "self tests" to assess the likelihood that they had SAD and GAD (www.paxil.com). This kind of clinical ambiguity is fertile ground for creating an expansive medical market.

Some question the validity of SAD, due to

its loosely defined boundaries and the aggres- sive marketing of it as a disease: "[T]he impression often conveyed by commercials for the drugs is clear: almost anyone could benefit from them" (Goode 2002). Murray Stein, a psychiatry professor at the University of California at San Diego, has called the use of prescription medicines such as Paxil, which are costly and may have significant side effects, "cosmetic psychopharmacology" (Vedantam 2001:1). Paxil's web page (www.paxil.com) stresses the elimination of symptoms (e.g., improved sleep) and improved performance (e.g., "improved ability to con- centrate and make decisions") as benefits.

Efforts to define SAD and GAD as condi-

tions, and market Paxil as treatment for them, have been extremely successful. Paxil is one of the three most widely recognized prescription drugs, after Viagra and Claritin (Marino 2002), and it is currently ranked sixth in terms of pre- scriptions (Nittan 2001), with U.S. sales of approximately $2.1 billion and global sales of $2.7 billion. It is of course not possible to dis- tinguish how much of this was for SAD or GAD and how much of it was prescribed for other problems including depression, obses- sive compulsive disorder, or post traumatic stress disorder.

But there has been some recent backlash

against the drug. In 2002, a federal judge ordered a temporary halt to Paxil ads over the claim that Paxil is not habit forming (White 2002). Apparently, patients and health care providers have submitted thousands of reports to the FDA describing withdrawal symptoms (Peterson 2002). Multiple lawsuits have been filed, asserting that physicians and consumers were misled by advertisements regarding the severity of withdrawal (Barry 2002). Like sim- ilarly marketed consumer goods, such as music and clothing, it is possible that Paxil's popular- ity may be waning. However, along the way, the GalaxoSmithKline campaign for Paxil has increased the medicalization of anxiety, infer- ring directly and indirectly that shyness and worrying may be medical problems and that Paxil is the way to treat them.

DEVELOPMENT OF PRIVATE MEDICAL MARKETS

When treatments or services are not covered

by health insurance, but the demand for the

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MEDICALIZATION, MARKETS AND CONSUMERS 165

medical service or treatment remains, a private medical market may evolve. Private medical markets emerge when an available medical intervention-frequently medical technology or an "off-label" use of an approved drug- meets consumers willing to pay out of their pockets to receive treatment. Such markets are sustained by consumer demand, and they can be expanded by increasing the availability of the intervention, reducing the cost of the treat- ment, or expanding the range of uses or target populations. Some of these interventions can be seen as medical enhancements rather than

treatments for a disease, but this is a slippery slope. This commercialization of medicine has been well-developed in cosmetic surgery (Sullivan 2001), but it exists in other areas as well. The relation of increasing medicalization and private markets for biomedical enhance- ments and technology are illustrated through two cases: the use of human growth hormone for idiopathic shortness and in vitro fertiliza- tion for infertility.

Human Growth Hormone and Idiopathic Short Stature

Medications are frequently prescribed for "off-label" uses, as treatments of conditions beyond those approved by the Federal Drug Administration. While physicians, in practice,2 have autonomy and authority to prescribe for off-label uses of a drug, manufacturers cannot legally market for off-label uses.

Prior to 1985, human growth hormone extracted from cadavers was used to treat indi-

viduals who had a growth hormone deficiency. The growth hormone was in low supply and thus very expensive and carried severe risks of Creutzfeldt-Jacobs disease, a potentially fatal brain disease. In 1985 the FDA removed it

from the market. With fortuitous timing, Genentech introduced an FDA approved syn- thetic human growth hormone within six months of the removal of cadaver-extracted

growth hormone. The recombinant hormone, marketed as Protropin, could be produced in "potentially unlimited quantities" (Lantos et al. 1989:1020) to such an extent that physi- cians credited the new technology with ending the market shortage of the hormone (Glasbrenner 1986). Genentech soon claimed 75 percent of the existing $200 million U.S. market (Werth 1991). The hormone had been

approved by the FDA only for treating hypopi- tuitary dwarfism (or growth hormone defi- ciency) and chronic renal failure. While indi- vidual cases might be disputed, the medical profession established strict guidelines (Bercu 1996) to distinguish between growth hormone deficiency disorder and what has been called idiopathic short stature or ISS (children with normal growth hormone who are short).3

As time went on, physicians, patients, and drug companies all sought other medical uses for human growth hormone. By 1990, researchers and leading drug companies were investigating the possibility of administering human growth hormone to children with "idio- pathic short stature," that is "normal" children who were of short stature but had no deficien-

cy of the hormone. Short stature is defined as the lower 3 percentiles for age and sex, which is roughly two standard deviations below the sex-age means. For adult males it is 64.5 inch- es or less; for adult females it is 59.5 inches (NHANES 2000). It is estimated that 1.8 mil- lion children in the United States and a similar

number in Europe can be characterized with significant short stature. Only 20 percent of these are referred to pediatric endocrinologists and only 5 percent of these are growth hor- mone deficient (Hintz 1996). The vast majori- ty of short children therefore can be considered idiopathic short stature, defined as "a hetero- geneous state that encompasses individuals with short stature, including those with FSS (familial short stature), for which there is no recognized cause" (Kelnar et al. 1999:151). The causes of short stature may well be famil- ial (short parents), genetic, or nutritional, but it can be seen as "normal shortness" as opposed to more specific "deficiency shortness."

A national survey of 534 pediatric endocri- nologists documented that 94 percent of them had prescribed human growth hormone within the previous 5 years for children who were not hormone deficient (Cutler et al. 1996:532). Genentech and, to some extent, Eli Lilly (who marketed a similar hormone) worked closely with the Human Growth Foundation, a non- profit advocacy group that supported "short children" (Werth 1991), a more general term including both hypopituitary dwarfism and idiopathic short stature. Genentech also sup- ported research by pediatric endocrinologists and began its own longitudinal research on "healthy" children who were not hormone deficient. These activities further blurred the

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boundaries demarcating "legitimate" and "off- label" use of human growth hormone.4 In 2003, the FDA approved Eli Lilly's Humatrope to treat idiopathic short stature children in the shortest 1.2 percent of the population, which will likely accelerate its use in potentially short children (Kaufman 2003). There is some evidence that shortness (and

especially extreme shortness) often is a deval- ued status and can have social consequences, especially for males. Some researchers have found social disadvantages of shortness, including discrimination in hiring and salaries, assumptions regarding maturity and compe- tence, issues around self-esteem and perceived attractiveness, and practical problems such as buying well-fitting clothes (see Conrad and Potter 2004). Whatever the real or imagined disadvantages of shortness, some parents have anxieties about their children's height. With the availability of synthetic human growth hor- mone, parents could consider interventions that would influence the height of their chil- dren.

At least 13,000 children in the United States with idiopathic short stature were treated with human growth hormone in 1994.5 Research on growth hormone treatment with idiopathic short children has been equivocal. It is debat- able how much treatment can increase growth from predicted height (cf. Hintz 1996). One major multi-center study, sponsored by Genentech, reported that of the 80 individuals in the study who reached final height, the mean gain from predicted height was 5.9 cen- timeters in girls and 5.0 centimeters in boys (Hintz et al. 2000). The height gains are mod- est; human growth hormone will not transform a short person into a tall one, but only into a less short one. Human growth hormone treat- ment costs about $20,000 a year and must be continued for three to six years. Parents of idiopathic short stature children must pay this out of their own funds, since health insurance will only cover treatment for hormone defi- ciency. If the average height gain is two inch- es, and the average cost is $100,000, the cost of height enhancement is roughly $50,000 an inch.

The relative ease with which manufacturers

may promote and physicians may prescribe human growth hormone for off-label treatment has increased the range of possible uses (Conrad and Potter 2004). The Federal Drug Administration Modernization Act of 1997

eased limitations upon manufacturers, broad- ening the information that they may provide to physicians about off-label use of their products (Stapleton 1999). In terms of shortness, the potential market is considerable, with nearly four million children in the United States and

Europe who could be defined as having idio- pathic short stature. This could further increase the medicalization of short stature.

In Vitro Fertilization and the Medical

Treatment for Infertility

The development of reproductive technolo- gies has resulted in the medicalization of infer- tility. In vitro fertilization (or IVF), in which eggs are abstracted and fertilized and then implanted inside a woman's uterus, is one such case. When it was first practiced successfully, resulting in the conception of the first "test tube baby" in 1978, in vitro fertilization held out hope of a technological "fix" to an esti- mated 7 percent of couples who experience infertility (Centers for Disease Control 2001). "Persons now perceive that not only can the source of infertility be diagnosed, but it can be treated" (Scritchfield 1995:139), and assisted reproductive technology "has transformed infertility into a clinical need" (Bates and Bates 1996:301).

Yet the medical market for in vitro fertiliza-

tion has remained fairly constrained because many consumers do not have insurance cover- age for in vitro fertilization (Neumann 1997). One study found that a minority of plans (14 to 17 percent, depending upon the type of plan) cover in vitro fertilization (Alan Guttmacher Institute 1993), and another study found that 30 to 40 percent of in vitro fertilization ser- vices are covered partially and that insurance reimburses for about half of the costs when in

vitro fertilization is covered (Collins et al. 1995). At first, health insurers justified their exclusion of IVF from coverage on two grounds: efficacy and cost. Initially, success rates were estimated to be 15-20 percent per attempt (Kolata 1983), and recent estimates of success rates range from 32.2 percent for women under 35 years to 9.7 percent for women ages 40-41 (Centers for Disease Control 2001). Insurance companies have often labeled in vitro fertilization as "experi- mental," as a result of these relatively low suc- cess rates. In vitro fertilization is also a fairly

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MEDICALIZATION, MARKETS AND CONSUMERS 167

expensive treatment, costing about $10,000 on average for one cycle (Wilcox and Rossi 2002), and it often requires multiple cycles to produce a successful pregnancy, if a successful outcome is attained at all. Some insurance car-

riers provided coverage for assisted reproduc- tive technology when it first became available but dropped that benefit (Lang 1998) or decid- ed to charge extra for in vitro fertilization cov- erage (The New York Times 1998).

In response to insurers' overall refusal to cover in vitro fertilization, many middle and upper-middle class couples pay the cost out-of- pocket, using their savings and going into sub- stantial debt. Pamela Madsen, the executive director of the New York chapter of Resolve, an infertility support and advocacy group, had two babies using in vitro fertilization. She described her difficulty to a reporter:

I'm tapped out, mortgaged out, credit-card- ed out. And we were lucky. We got our babies. We still live in a one-bedroom

apartment. We had a nest egg when we got married; we had health insurance, and the system wasn't there for us (Lang 1998:12).

Facing looming personal debt from infertili- ty treatment and substantial resistance from health insurers, middle and upper-middle class consumers have turned to litigation and legis- lation as means of gaining rights to reimburse- ment for in vitro fertilization. These couples have made "a claim upon society to guarantee, through whatever means possible, the capacity to reproduce" (Blank 1997:281). Thus far, nine states have passed legislation regulating health insurance coverage of in vitro fertilization in response to advocacy efforts by groups such as Resolve (the largest fertility support group in the United States). Recently, there have also been some calls for federal legislation to "pro- tect the insurance rights of infertile couples" (McKee 2001).

Consumers have also sought health insur- ance coverage for in vitro fertilization through the courts, claiming that infertility is an illness or a disability, but such attempts have had only limited success. In this arena, consumers and insurers have wrestled over the medicalization

of infertility and over in vitro fertilization as a treatment for infertility. The position that infer- tility is a disease is supported by the American Society for Reproductive Medicine, which states that, "infertility is a disease of the repro- ductive system that impairs one of the body's most basic functions: the conception of chil-

dren" (American Society for Reproductive Medicine 2002). Earlier cases in which con- sumers claimed that infertility is an illness were sometimes successful (e.g., Witcraft v. Sundstrand Health and Disability Group Benefit Plan and Egert v. Connecticut General Life Insurance Co.). More recent consumer claims that infertility is a disability, and that insurers' lack of coverage of in vitro fertiliza- tion constitutes discrimination under the Americans with Disabilities Act of 1990 have

had less success in the courts (e.g. Zantanian v. WDSU-Television Inc. and Krauel v. Iowa

Methodist Medical Center). Insurers have fought hard against claims of

infertility as an illness or a disability, making three main defenses: "(1) infertility is not an illness; (2) artificial reproductive technology (ART) is not medically necessary; and (3) ARTs are experimental" (Gilbert 1996:44). Regarding infertility as an illness, "some argue that infertility is sought by some couples and suffered by others. Therefore, it is a socially constructed need-not a medical need" (Bates and Bates 1996:301). Nonpregnancy is not an illness. Some insurers have argued that infer- tility treatment is elective and does not cure any sickness or disease (Tischler 1994). The medical necessity argument has been used to exclude in vitro fertilization from coverage by drawing attention to the social aspects of infer- tility and uses of IVF. Some contend that this argument is used to control in vitro fertiliza- tion's fiscal impact on insurers (Hughes and Giacomini 2001), restricting the use of in vitro fertilization to a small number of cases in

which the source of infertility problems can be specifically pinpointed and addressed. For example, the use of in vitro fertilization to bypass blocked or damaged fallopian tubes is a very specific, medical use of the technology. The use of in vitro fertilization to address

infertility associated with age or to help single or lesbian women have biological children is more social. This medical necessity argument has had some success in the courts (e.g., Kinzie v. Physicians Liability Insurance Company 1987).

Even with a few successful court cases, insurers in general have not accepted con- sumers' claims that infertility is a disease or disability and have not increased coverage. As a result, many consumers must still pay out-of- pocket for in vitro fertilization services, and some fertility clinics have turned to creative

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financial arrangements to increase the private market for their services. These arrangements offer money-back guarantees or substantial refunds if patients do not get pregnant or if they miscarry early in the pregnancy (Hamilton 1996; Wilcox and Rossi 2002; Wozencraft 1996).

The private market for in vitro fertilization appears to be here to stay. Physicians are drawn to reproductive medicine because of the "cut- ting edge" nature of the work, as well as the potential for commercial profit (Brody 1987). In vitro fertilization clinics advertise using Internet websites with links to finance compa- nies to help pay for the procedure. Consumers who wish to have biological children are drawn to technological solutions to infertility. Yet the consumer demand for in vitro fertilization and

other reproductive technologies is constrained by insurers' refusals to pay for such services, except under specific "medical" circum- stances. This has resulted in the creation of a

private medical market for consumers who can afford to pay for in vitro fertilization or who are willing to take on significant debt to do so.

DISCUSSION

We have described four cases where the

development of medical markets facilitated medicalization, and we have identified two forms of medical markets: mediated and pri- vate markets. We outline the main attributes of

these markets in Table 1. In mediated markets, corporate medical producers attempt to increase demand for their products by promot- ing directly to consumers and providers, with the market mediated by health insurers and managed care organizations. Consumers become the target for market expansion, with physicians largely remaining as gatekeepers prescribing treatment.6 In private medical mar- kets, due to limits in types of promotion per-

mitted (e.g., for off-label uses), corporations promote indirectly to providers or consumers (e.g., on the Internet). Consumers are the prime driver for demand, generally without insurance support, and must pay directly for medical products or services. Physicians are necessary facilitators for treatment but are sometimes promoters (i.e., entrepreneurs) for the product as well (e.g., cosmetic surgery).

There may be a tension between restricted access to health care and the expansion of mediated and private markets. Private markets tend to emerge when insurers define a problem or treatment as not medically necessary and therefore not subject to third party reimburse- ment. Thus insurers here attempt to constrain access to medicalized solutions by refusing to cover particular treatments or services. These markets are not fixed; given changes in pro- motion, insurance coverage, or consumer role, private markets could become mediated mar- kets and vice versa. In operation, such markets are more on a continuum than mutually exclu- sive in their attributes.

A key to all markets is the existence of a medical product and consumer demand. In some cases, the pharmaceutical companies develop strategies to expand their markets (e.g., Viagra and Paxil), while in others the markets are more consumer-driven. Table 2

outlines the different modes of promotion and their relation to medicalization.

In two cases the development of medical markets is primarily corporate driven. Viagra and Paxil are promoted by pharmaceutical companies through direct-to-consumer adver- tising, but the goals and means differ. With Viagra, the goal is to increase the appeal of the product to a wider population. When first introduced, Viagra was aimed at older men or others with established erectile dysfunction. However, in recent years much of the advertis- ing has been aimed at a younger and broader population, with the implicit message that

TABLE 1. Comparison of Mediated and Private Markets

Relation to Mediated Markets Private Markets

Corporate Direct promotion to providers and consumers Indirect promotion to providers via off-label (direct-to-consumer advertising) use or consumers on the Internet

Insurers Problem is generally covered by insurance with Problem is not covered relatively flexible criteria by insurance or only covered under strict

medical criteria

Consumers Targeted for market expansion Promoter of market expansion Physicians Gatekeeper, with authority to define problem Facilitator, with authority to define problem

and prescribe treatment and prescribe treatment

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MEDICALIZATION, MARKETS AND CONSUMERS 169

TABLE 2. Promotion of Medical Markets and Medicalization

Product Promoter Goal Means Medicalization

Viagra Corporate Driven Create new populations Direct-to-consumer Expands diagnosis of for product advertising to younger erectile dysfunction

and "virile" types Paxil Corporate Driven Create new problems for Direct-to-consumer "dis- Promotes disorders of

approved product ease awareness cam- SAD and GAD paign"

Human Consumer and Expand product to non- Secure "off-label" use of Makes short stature into Growth Corporate Driven FDA approved uses product a medical problem Hormone

In Vitro Redefine infertility into Seek right to treatment Further medicalizes Fertili- Consumer Driven a health problem so through legislation infertility zation technology is covered and litigation

by health insurance

Viagra can help them too with whatever sexual/ performance problems they may have. This market expansion means offering a medical solution to a wider range of mild or transitory erectile problems. The promoters of Paxil, on the other hand, want to differentiate their drug from others on the market. After getting FDA approval for new uses, GlaxoSmithKline developed a direct-to-consumer "disease awareness campaign" to "alert" consumers that they might have a diagnosable problem (e.g., SAD) and that Paxil could be the right choice for them. This encourages people to redefine their life difficulties in medical terms

and creates a further demand for the product. In both cases the advertising aims to increase the consumer demand for the medical treat-

ment product. Increased medicalization is a by-product.

Human growth hormone can be seen as jointly corporate and consumer driven. While there was no direct corporate product advertis- ing to consumers, Genentech had to pay a $50 million settlement for "overpromoting" human growth hormone to medical practitioners for treating unapproved conditions (including idiopathic short stature) (Nordenberg 1999). It is unclear how much the promotion to doctors and hospitals stimulated the development of the medical market for growth hormone, but is safe to assume it had some effect. Genentech

and other pharmaceutical companies support consumer groups that promote hormone inter- ventions for idiopathic short stature, but con- sumer groups are the primary advocates for human growth hormone treatment (Conrad and Potter 2004). For in vitro fertilization, con- sumers are the main proponents pressuring for insurance coverage. Through organizations, lit- igation, and legislation, consumers are striving

to achieve medical legitimacy for all kinds of infertility so that third parties will pay for treatment. When human growth hormone for idiopathic short stature and in vitro fertiliza- tion for infertility are not covered by health insurers, consumers must pay for these ser- vices out-of-pocket, creating a private medical market. This type of market has all the charac- teristics of any private market: Those who can afford to pay can acquire the services.

Medical markets can change, based upon whether insurers deem the product to be a medical necessity and cover a service or drug. The in vitro fertilization debate clearly turns on whether infertility treatment is medically necessary; consumers say it is and should be covered by insurance while insurers claim hav- ing children is a social choice, not a medical one. We see medical necessity reflected in the human growth hormone and Viagra cases as well, even if the term is not typically applied. Consumer advocates claim that human growth hormone is a medical necessity since medical treatment could mitigate the suffering, stigma, and discrimination due to the biological limita- tion of extreme shortness. Is the treatment of

erectile dysfunction a medical necessity? In terms of insurers, the answer is, "sort of." When insurers cover the cost of Viagra, they often limit it to four to eight pills a month. Does this mean sexual intercourse is a medical

necessity four to eight times a month? It is also possible to see some uses of human

growth hormone, Viagra, Paxil and in vitro fer- tilization as biomedical enhancements rather

than treatments. While there are certainly med- ically legitimated uses for each of these drugs and procedures, some uses may constitute enhancement rather than treatment. Biomedical enhancements are medical inter-

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ventions used to improve physical or mental characteristics or performance in those with no identifiable pathology. Adding a few inches of height to one's child, insuring strong erections, increasing one's social abilities, or having a biological child might all be improvements that could be sought by many individuals. One need not have a disorder to benefit from these

medical interventions. Peter Kramer (1993) claimed that Prozac can make people "better than well." There has been some debate in the bioethics literature about a distinction between

therapy and enhancement, but medicalizing human problems creates a slippery slope between enhancement and legitimated medical treatment (Conrad and Potter 2004).

While erectile dysfunction, anxiety, short stature, and infertility surely can impact peo- ple's lives to varying degrees, they are not life- threatening conditions nor even major health risks. Anti-hypertensive or cholesterol reduc- ing drugs associated with cardiovascular dis- ease are also widely promoted, but for a well established medical problem. While prevention of disease is a major market for drugs and interventions, the relatively common problems of life, on the margins of medicine, hold the greatest potential for market expansion and medicalization.

The role of physicians as "providers" is changing in the current medical marketplace, with some areas shifting more than others. With off-label uses of drugs like human growth hormone for idiopathic short stature, physicians play a facilitating role in the mar- ket. It is a physician's prerogative to prescribe medications for uses beyond those approved by the FDA. Doctors commonly prescribe drugs for unapproved uses if, in their judgment, the drug would be an effective treatment for a patient's problem. Similarly, technical inter- ventions such as in vitro fertilization would be

totally unavailable without physician involve- ment. Thus physicians still have an important central role in facilitating medical markets, especially in private markets.

But the physician's role is challenged on other fronts, particularly with direct-to-con- sumer advertising undermining physicians' authority regarding which drugs to prescribe. Physicians have always been the major conduit between the pharmaceutical industry and patients (which is why the pharmaceutical industry spends billions of dollars advertising and promoting their wares to physicians).

Physicians in the past have provided prescrip- tions in response to patients' direct requests, even when the scientific knowledge suggested that it was not appropriate, because they wor- ried about economics and their professional image and because they wanted to respond to patients' requests for help (Schwartz, Soumerai and Avorn 1989). But direct-to-con- sumer advertising has increased consumers' role in the prescribing equation. While physi- cians remain the gatekeeper to these drugs, reflected in most direct-to-consumer ads end-

ing with a statement like, "ask your doctor if Paxil [or Viagra] is right for you," there is increased pressure to respond to consumers' independent requests for medications. In the context of current debates regarding chal- lenges to physicians' professional knowledge (Timmermans and Kolker 2004), it appears that pharmaceutical manufacturers are circum- venting physicians' control over knowledge regarding available drugs.

Insurers as "payers" exert a strong influence on medical markets. In the context of the

examples presented here, insurers including HMOs set the limits on some medical markets, thus acting as a constraint on access to med- icalized solutions to human problems. This is particularly clear with in vitro fertilization, where insurers' definition of the treatment as

"experimental" and their refusal to cover it except in very specific diagnostic situations has limited in vitro fertilization to those who

could afford to pay for it. Insurers will only pay for human growth hormone for children with a diagnosed growth hormone deficiency; idio- pathic short stature children only receive treat- ment if their families can pay for it. Few can afford the tariff. Even with Viagra, some insur- ance plans don't cover this treatment for erec- tile dysfunction, while others limit the use. It has long been an axiom in medicalization stud- ies that the only way to get human services paid for is to turn life difficulties into medical problems. Yet under managed care insurers are responding to this medicalization by restricting payment for these services. Insurance con- straints do not necessarily affect the conceptu- al level of medicalization but they constrain access to medicalized solutions at the patient

level (Conrad and Schneider 1980)7. By restricting access to medical solutions in the name of "medical necessity" insurers attempt to limit individuals' claims that they are suffer-

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MEDICALIZATION, MARKETS AND CONSUMERS 171

ing from illnesses rather than everyday life (Sabin and Daniels 1994).

Consumers have a dual role related to med- ical markets. In some instances the market for

a problem exists long before any medical pro- motion. Individuals have been seeking nos- trums to improve sexual performance or votive objects to insure fertility for centuries, while short people have often tried to appear taller (think elevator shoes and high heels). In a sense, there is a ready-made market demand for a product. Consumers and medical interests are already allied, and consumers may become the dynamic force for market creation. In other cases, the public constitutes potential con- sumers who must be shaped into a market. This involves persuading consumers of the necessi- ty or utility of a product offered or creating consumer demand. Direct-to-consumer adver-

tising for Paxil exemplifies this, although it is partly true for Viagra as well. Such promotion can induce people to self-label their problems as medical entities and seek more medical ser- vices. This medical commodification shifts both definition and solution into the medical

sphere. Recent changes in FDA regulations allow

for a different kind of drug marketing by loos- ening off-label provisions and enabling televi- sion advertising of prescription drugs, facili- tating the emergence of new medical markets. Broadcast ads can now name the disorder and

the drug, so long as they include limited risk and benefit information (Lyles 2002). As noted, corporate pharmaceutical spending on television advertising increased six-fold from 1996 to 2000, and ads for products such as Paxil and Viagra have become common.

Off-label uses of FDA approved drugs is one of the easiest routes to the expansion of med- ical markets. Once a drug has been approved for one use or population, it can be prescribed for broader purposes. Ritalin is approved for childhood ADHD, but for the past decade it has been used widely with adults (Conrad and Potter 2000). Provigil (modafinil) is approved for sleep disorders, such as narcolepsy and hypersomia, but in its direct-to-consumer advertising, Cepahlon, the manufacturer, has touted that the drug can drastically reduce the amount of sleep required without affecting performance (Wolpe 2002). While drug com- panies have been limited in their advertising for off-label uses, FDA regulations allow for considerably more latitude in promotion.

Manufacturers will likely promote off-label applications to the extent legally permitted, perhaps expanding diagnoses (Conrad and Potter 2000) and further medicalization.8

Medicalization narrows the definition of health and widens the definition of sickness.

The direct-to-consumer advertising focuses on "help seeking" advertisements (Lyles 2002), which try to create an "awareness" of symp- toms or conditions among consumers. "Consumer education campaigns" are used to introduce new products or extended applica- tions, essentially bringing new people into a market by creating a previously unrecognized demand for a product (Applbaum 2000). The marketing of Viagra expands the bounds of erectile dysfunction, implying that it is not "healthy" or "normal" to have variation in penile erections. Paxil ads emphasize that it may be pathological to be anxious or shy in social situations and that this can be changed by using the drug. Employing human growth hormone to treat short stature indicates a nar-

rowing of the range of normal height as well as reinforcing the notion that shortness is deviant and undesirable, and that it should be altered. The marketing of Paxil, Viagra and, to a lesser degree, human growth hormone targets rela- tively healthy people. Drug companies' search for markets creates broader disease definitions

for their products, indirectly reducing what is "normal."

CONCLUSION

We highlight the increasing importance of pharmaceutical companies, insurers, and con- sumers for medicalization as they are involved in the creation of medical markets. The med-

ical profession has a diminished but still key role in medicalization. Given the changes in medicine and its organization, important are- nas of medicalization are moving from profes- sional to market domains.

It is not new knowledge or technology that engenders medicalization but how they are used. Corporate and medical promotion of products, treatments, and drugs underlies the emergence of new medical markets. With our corporatized medical-industrial complex, the creation or expansion of medical markets becomes an important conduit to medicaliza- tion. Consumer demand is not simply unfet- tered desire for medical solutions, but it is

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172 JOURNAL OF HEALTH AND SOCIAL BEHAVIOR

shaped by the availability and accessibility of medical interventions. This creates a new set of

relationships among corporate entities, insur- ers, physicians, and consumers.

In the context of the changing balance of power among the medical profession and relat- ed institutions, the engines of medicalization are found in the marketplace nexus of the biotechnology industry and rising con- sumerism. The brakes take the form of insur-

ers, including private and government spon- sored managed care. As corporate entities and consumers pursue the goals of promotion or reception of new medical interventions, we are likely to see the development of new medical markets along with a growing pressure to med- icalize the troubles and problems of everyday life.

NOTES

1. According to the DSM, the diagnostic crite- ria for SAD include: a marked and persis- tent fear of social or performance situations in which embarrassment may occur, an immediate anxiety response, a recognition that the fear is excessive or unreasonable, avoidance of the situation or endurance

with dread, interference with daily routine or marked distress about the phobia, and the fear not being due to substance effects or other conditions (American Psychiatric Association, 1994:411).

2. Professional medicine has long approved of off-label uses of drugs. In 1999, the American Medical Association approved a position statement (Resolution #528), intro- duced by the Society of Cardiovascular and Interventional Radiology, on off-label use of devices and medications. In summary, the AMA permits physicians to decide what to prescribe for their patients and for what medical conditions, because physicians are best able to base these decisions on "current

clinical standards and not just FDA- approved indications."

3. Criteria include (1) height of less than three standard deviations below the mean for a

child's age and sex, (2) abnormal growth velocity (less than 25th percentile for bone age), and (3) growth hormone provocative testing results with peak growth hormone of less thanl0 (g/L in a polyclonal radioim- munoassay (Bercu 1996). It is this latter cri-

terion that has produced the most contro- versy (Lantos et al 1989; Bercu 1996). For example, peak growth hormone levels between 7 and 10 are considered a "gray zone," and different methods of assessing growth hormone levels produce varying results (Lantos et al. 1989).

4. In 1994, several federal agencies began a series of investigations targeting Eli Lilly and Genentech for overpromoting their growth hormone products, that is, market- ing them for non-approved uses (for details, see Conrad and Potter 2002). The FDA alleged and documented that, by the end of 1985, Genentech had "begun marketing Protropin for use in the treatment of med- ical conditions for which it did not have

FDA approval" (Nordenberg 1999:33). From 1985 to 1994, Genentech marketed Protropin to a variety of medical practition- ers (doctors, hospitals, and others) for treat- ing unapproved conditions, including idio- pathic short stature (Nordenberg 1999). Genentech paid $50 million in settlement, including a $20 million penalty to reim- burse Medicaid and CHAMPUS

(Nordenberg 1999). 5. This is an extrapolation. In 1994, about

7,000 children were believed to suffer from short stature due to human growth hormone deficiency but 20,000 children were treated with human growth hormone (Biotechology News, 1994). Therefore at least 13,000 chil- dren were treated for idiopathic short stature that year.

6. There is increasing advertising on the Internet for Viagra, human growth hor- mone, and other prescription medications. While it is assumed that a doctor must eval- uate the short forms consumers need to

complete before ordering medications, the wide availability of medications through the Internet sources compromises the physi- cian's gatekeeper role.

7. Some have suggested that direct-to-con- sumer advertising is in part a reaction to managed care. Lyles (2002) notes that, "managed care controls that limit the physi- cian's prescription authority also reduce the potential of promotional activities targeting physicians; consequently pharmaceutical companies have responded by seeking alter- native ways to influence physician prescrib- ing" (p. 27).

8. A recent case illustrates this. Parke-Davis, a

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MEDICALIZATION, MARKETS AND CONSUMERS 173

major pharmaceutical company, developed a marketing strategy to promote their epilepsy drug, Neurontin, for four off-label uses. The company estimated it could earn $150 million by promoting the drug to doc- tors for social phobias, panic disorder, bipo- lar illness, and neuropathic pain in journals and at medical conferences rather than

embarking on the clinical trials and lengthy process of seeking FDA approval. 80 per- cent of the prescriptions for Neurontin are for off-label uses. U.S. sales for 2002 are

estimated as $2 billion. The company claims it was only distributing materials for educational purposes, but critics saw it as an unethical form of marketing (Kowalczyk 2002).

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Peter Conrad is Harry Coplan Professor of Social Sciences at Brandeis University, where he is also Chair of the Health: Science, Society and Policy program. He has published numerous books and articles and is currently completing a book on the medicalization of society.

Valerie Leiter is Assistant Professor of Sociology and Director of the Society and Health Program at Simmons College. Her work focuses on the social construction of childhood disability and the provision of health and therapeutic care to children with disabilities.

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