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Medicalization, Markets and Consumers*

Brandeis University

Simmons College

Journal of Health and Social Behavior 2004, Vol 45 (Extra Issue): 158176

This paper examines the impact of changes in the medical marketplace on medicalization in U. S. society. Using four cases (Viagra, Paxil, human growth hormone and in vitro fertilization), we focus on two aspects of the changing medical marketplace: the role of direct-to-consumer advertising of prescription drugs and the emergence of private medical markets. We demonstrate how consumers 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, consumers, 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. Delivered by Ingenta to : MrOver Matharu (cid 32629), ingenta internal live a 2.3.1/F4 (cid 75000325), University of Delaware the past three decades there has been process of medicalization been transformed as Library (cid 2443) marked increase in the medicalization of sociwell? In an ambitious paper, Clarke and her Tue, 27 Dec 2005 00:27:44 ety (Zola 1972; Conrad and Schneider 1992; colleagues (2003) argue that the technoscienBarsky and Boros 1995; Riska 2003). tific changes in medicine have expanded medMedicalization occurs when previously non- icines boundaries even further into biomedmedical problems are defined and treated as icalization, a wide ranging process that medical problems, usually in terms of illnesses includes complex and multi-sited transformaor disorders. While medicalization can be bi- tions in medical knowledge, technology, surdirectional, there is strong evidence for veillance, and bodies. Our task here is narrowincreases in medicalization. This growth of er and more focused. We ask, how have medical jurisdiction is one of the most potent changes in the institution of medicine affected transformations of the last half of the twentieth the process of medicalization? Have the shiftcentury in the West (Clarke et al. 2003:161). ing power dynamics in medicine altered medIn this same period, the institution of medicine icalization? What are current engines driving has undergone major changes in its social increased medicalization? What factors conorganization, with the advent of managed care, strain its growth? the declining power of the medical profession, Most previous analyses of medicalization and a rise in consumer advocacy and account- focused on the influence of physicians, lay ability (Starr 1982; McKinlay and Marceau reformers, or medical and scientific discover2001). As medicine has changed, has the ies. This paper departs from that tack, focusing instead on the creation of markets and the impact of these markets on medicalization. * Our thanks to Phil Brown, Emily Kolker, Stefan Although the players are similar, the emphasis Timmermans, anonymous reviewers, and the editors for comments on a earlier version of this paper. Send is different. Given the changing medical scene, correspondence to: Peter Conrad, Department of important arenas of medicalization are moving Sociology, MS-71, Brandeis University, Waltham, from professional to market domains. In this paper we examine the impact of MA 02454-9110. Email:

MEDICALIZATION, MARKETS AND CONSUMERS 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 system and expanding medical knowledge. The core of the paper focuses on two aspects of the changing medical market place: Direct-to-consumer 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 medicalization and to consumers access to health care.


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 communication among like-minded individuals (Hardey 2001). Organized lay interests and advocates frequently play a significant role in AGENTS OF MEDICALIZATION medicalization, such as in the creation and institutionalization (in DSM-III) of the diagnoThere are numerous broad social factors that sis post-traumatic stress disorder (Scott 1990). have encouraged or abetted medicalization, However, advocates for sexual addiction including the diminution of religion; an abid- (Levine and Troiden 1988) and multiple cheming faith in science, rationality, and progress; ical sensitivity disorder (Kroll-Smith and an increased reliance on experts; and a general Floyd 1997) have not had such success. humanitarian trend in Western societies New medical knowledge can also contribute (Conrad 1992:213). These factors, rather than to medicalization, especially in terms of etiolbeing explanatory, set the context in which ogy and treatment. The Human Genome Delivered by Ingenta : the attendant rise of genetics is one medicalization occurs. Projectto and Mr Matharu (cid 32629), live 2.3.1/F4 75000325), University of Delaware Sociologists and other ingenta analystsinternal have identimajor(cid potential source of increased medicalLibrary (cid 2443) If a problem can be shown to have a fied direct factors that facilitate medicalizaization. Tue, 27 Dec 2005 00:27:44 tion. Foremost among these, on the supply genetic component it becomes a good candiside is the prestige and power of the medical date for (new or renewed) medical definitions profession. It is well known that the medical (Conrad 2000). Similarly, the development of profession gained great influence and authori- new medical treatments with pharmaceutical ty in the first three quarters of the twentieth drugs can be an important factor in the medcentury, attaining both a professional domi- icalization of particular problems, such as the nance (Freidson 1970) and cultural authority impact of Ritalin on ADHD or estrogen (Starr 1982). Professional dominance and replacement therapy on menopause. However, medical monopolization gave medicine juris- it is important to emphasize that new biomeddiction over virtually anything to which the ical knowledge or interventions alone cannot label health or illness could be attached engender medicalization. Etiology or treat(Freidson 1970). Studies of problems ranging ment may be a central component of a claim to from childbirth (Wertz and Wertz 1989) to medicalization, but those claims must be child abuse (Pfohl 1977) to the rise of behav- championed by supporters or promoters of a ioral pediatrics (Halpern 1990) all purport diagnosis, be they physicians, patients, lay some kind of intra-professional explanation for advocates, or commercial entities such as drug an increase in medicalization. It should be companies. noted, however, that sometimes problems have Many of the key medicalization studies were been thrust onto the medical profession, which completed over a decade ago. Important may be resisted (e.g., Kurz 1987). changes have occurred in health care since On the demand side of medicalization, then, especially the increased corporatization there has been growth in consumer demand for of health care (Light 2000). Light (1993) has medical solutions. Barsky and Borus (1995) proposed the concept countervailing powers suggest that the publics tolerance for mild to describe the changing balance of power symptoms and benign problems has decreased, among the medical profession and related spurring a progressive medicalization of social institutions. In American society, profes-

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sional medicine historically dominated health There are, however, some medical markets care, but we now see buyers (e.g., corpora- that do resemble classic consumer markets, in tions that pay for employees health insurance); which goods and services are exchanged as providers (e.g., physicians, hospitals, commodities. Over the last few decades, the HMOs); payers (e.g., insurance companies, medical-industrial complex has grown, governments); and consumers (e.g., patients, mainly as a response to the entrepreneurial advocacy groups) all vying for power and opportunities afforded by the expansion of influence over medical care. The growing health insurance coverage offering indemnifiinfluence of the biotechnology industry (espe- cation through Medicare and employmentcially the pharmaceutical and genomics indus- based plans (Relman 1991:856). In short, the tries), has increased the complexity of the the existence of third party funding has encourmedical-industrial complex (Relman 1980; aged certain types of medical markets because of available insurance, although this has been Clarke et al. 2003). In this paper we explore how the develop- partly restrained by managed care. The use of advertising, the development of ment and promotion of new technologies, consumer demand, and the emergence of new specific medical markets, and the standardizamedical markets have facilitated new areas of tion of medical services into product lines have medicalization. Using the cases of Viagra, contributed to an increased commodification Paxil, human growth hormone, and in vitro of medical goods and services. Advertising of fertilization (IVF) as illustrations, we contend health care has become more commonplace that, in the climate of increased corporatization (Dyer 1997), and new medical markets have of health care and decreased public regulation, emerged, particularly for specialty services. the creation or expansion of new medical mar- Imershein and Estes (1996) argue that medical kets are a significant force toward medicaliza- services are increasingly organized into product lines (with attached payment schemes), tion. consistent Delivered by Ingenta to : with a market-based approach to exchange. Cosmetic surgery is the comMr Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cid 75000325), University of most Delaware ON MEDICAL MARKETS modified Library (cid 2443) of medical specialties, offering treatments that are often not covered by insurance, Tue, 27 Dec 2005 00:27:44 Until the last decade or so, sociologists such as liposuction and breast augmentation rarely examined medicine as any kind of mar- (Sullivan 2001). Cosmetic surgeons advertise ketplace. But it is becoming clear that, with the to stimulate demand for their services, for development of managed care, corporatized which patients pay cash (or borrow from medicine, and the rise of the biotechnology finance companies that partner with cosmetic industry, medical markets are increasingly surgeons, much like purchasing a car). important in the analysis of health care. In the last five years, a loosened regulatory When medical products, services, or treat- environment has given pharmaceutical and ments are promoted to consumers to improve biotechnology companies more freedom in their health, appearance, or well-being, we see advertising their wares, both to physicians and the development of medical markets. The idea consumers. The Federal Drug Administration of medical markets has been described as a Modernization Act of 1997 made several theoretical anomaly (Light 2000:395), as changes that have facilitated medicalization. medical markets often do not meet many of the Most relevant to our analysis, the act loosened elements in classical definitions of a competi- the restrictions placed on the kind of informative marketplace. In a free market, consumers tion that pharmaceutical companies could are supposed to be informed, appreciate differ- share with physicians regarding off-label ences in quality, and have bargaining power uses of their drugs, and subsequently, the and free choice about buying, but these information that must be included in direct-toassumptions are often violated in health care consumer advertisements. markets (Lown 2000). Asymmetry of informaThe constant development of new technolotion and uncertainty in the definition, recog- gies, treatments, and drugs sparks consumer nition, and diagnosis of disease states interest in obtaining access to these new med(Montagne 1992:401) in particular distinguish ical goods and services, and advertising can medical markets from other consumer mar- further increase consumer demand. Consumers kets. may gain access to these goods and services



through one of two kinds of markets: mediated components of health care, rising at 15 percent a year, now constituting 8 percent of health markets and private markets. In mediated markets, there is an indirect care spending (Angell 2000). In the same year, relationship between consumers, on the Americans purchased 2.5 billion prescriptions, demand side, and medical producers or averaging nine per American, for a total of providers, on the supply side, with third party $125 billion (Cohen et al. 2001). The pharmapayers occupying an intervening role. Third ceutical industry has a long history of marketparty payers (typically private or public insur- ing prescription medication directly to doctors ers) intervene in the exchange relationship through detailing, direct mail, ads in medical between consumers and providers or producers journals, gifts, travel subsidies, and sponsoring in two ways: by defining what is medically events (Wanzana 2000). While some direct-to-consumer advertising necessary and then paying for only those goods and services that they have deemed existed in the United States for over two medically necessary. The degree of control decades (Pines 1999), recently the pharmaceuexercised by third party payers varies, depend- tical industry has substantially increased its ing upon the level of management of care investment in targeting consumers directly. being exercised. Managed care regulations Annual spending on direct-to-consumer adverdampen consumer demand for medical goods tising for prescription drugs tripled between and services, particularly regarding access to 1996 and 2000; it is only 15 percent of all marnew technologies (Mechanic 2002), reducing keting, but by far the fastest rising segment. consumers ability to purchase medical solu- Much of this increase has been in television advertising after the Federal Drug tions to perceived health problems. Consumers who want medical goods or ser- Administration Modernization Act of 1997 vices but cannot obtain them through mediated made it easier to advertise drugs to the general markets may turn instead to private markets, public (Lyles 2002). This change allowed depending upon the cost of the goods or ser- broadcast ads to name both the disorder and DeliveredIn by Ingenta to so : long as they also contain limited the drug vices and consumers financial resources. Mr Matharu (cidthere 32629), internal live 2.3.1/F4 (cid benefit 75000325), University of Delaware risk and information, making televiprivate markets, is a ingenta more direct economLibrary 2443) sion drug advertising more feasible and more ic relationship between consumers and med-(cid Tue, 27 Dec 2005 00:27:44 ical producers or providers: If consumers can attractive to the pharmaceutical industry. afford a treatment, they can most likely find a Spending specifically on television advertising medical provider who will provide it for increased six-fold between 1996 and 2000, to cash. Again, cosmetic surgery is one exam- $1.5 billion dollars (Rosenthal et al. 2002). The pharmaceutical companies claim that ple of private medical markets. In private medical markets, care is provided to consumers direct-to-consumer advertising has an educawho can afford to pay for it, and other potential tional function that creates better informed consumers, encouraging consumers to consult consumers are excluded. In our analysis, we examine how four rela- their physicians about underdiagnosed symptively recent medical developments are distrib- toms and treatment options, and enabling uted through mediated and private markets, patients to make better choices (Bonaccorso and how distribution through these two types and Sturchio 2002; Lyles 2002). Critics are of markets is related to medicalization. concerned that such advertising leads to physiSpecifically, we look at (1) the creation of cians wasting time during medical visits demand for new medical products in mediated explaining why a treatment is not appropriate, medical markets; and (2) the development of can lead to unnecessary use of medical resources and excessive profits for drug comprivate medical markets. panies, and medicalize normal conditions (Mintzes 2002; Rosenthal et al. 2002). The vast majority of direct-to-consumer advertisCREATING AND CAPITALIZING ON ing focuses on a limited number of drugs; in MEDICAL MARKETS 2000, 20 drugs accounted for 60 percent of In 1999, the pharmaceutical industry was direct-to-consumer advertising. These include the most profitable industry in the United a wide range of drugs, including antidepresStates, with an 18.6 percent return on revenues sants, antihistamines, antihyperliplidemics, (Angell 2000). It is among the fastest growing and anti-inflammatory agents.

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One aspect of direct-to-consumer advertising that has not been discussed is its impact on expanding the medicalization of human problems. So-called consumer education campaigns are used to introduce products, bringing new people into a market by creating a previously 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. 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 dysfunctional (Laumann et al. 1999). Erectile difficulties affected not only men but their partners as well, and they were linked to powerful issues surrounding masculinity and sexual performance, making erectile dysfunction central to masculine self esteem (Teifer 1994:370). Pfizer Pharmaceuticals, the manufacturer of Viagra, tapped into this vast potential 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 concern with sexual performance insecurity, the Viagra and Erectile Dysfunction potential American market was huge, with an even more extensive worldwide market. The Male impotence has been a medical problem initial advertising for Viagra was minimal for many years. There is some evidence of (Carpiano 2001), but Pfizer soon marketed medicalization in the Victorian era (Mumford Viagra aggressively both to physicians and the 1992), although its dominant framing through- general public. The direct-to-consumer ads out much of the 20th century appears to have included spokesmen as mainstream as former been as a psychogenic problem. InDelivered the 1990s, Senatorto and by Ingenta : Presidential candidate Bob Dole, the redefined asinternal sexual live dys-2.3.1/F4 well recognized athletes, and ordinary people, Mr problem Matharu became (cid 32629), ingenta (cid 75000325), University of Delaware function and its treatment was promoted by (cid all testifying to the wonders of Viagra and how Library 2443) urologists, the medical technology industry, it has changed an important part of their lives. Tue, 27 Dec 2005 00:27:44 mass media, and entrepreneurs (Teifer 1994). One typical ad showed baseball star Rafael A consensus conference in 1992 officially Palmiero with the words I take batting pracrenamed the problem erectile dysfunction tice, indicating both that vigorous athletes can (National Institutes on Health Consensus take Viagra and that even stars might need Development Panel on Impotence 1993), high- some help in performance. Viagra became an lighting its nature as a biogenic rather than official sponsor of major league baseball, as psychogenic problem. Available treatments well as sponsoring both the Viagra car in the such a penile surgery, implants, and injections NASCAR circuit and Spanish language soccer were medical, although their results were broadcasts. Thus advertising expanded the mixed (Teifer 1994). market to include virtually any man who might In March 1998, the Federal Drug consider himself as having some type of erecAdministration (FDA) approved Viagra (silde- tile or sexual problems. nafil citrate) as a treatment for erectile dysViagra sales were phenomenal. Physicians function. Intended primarily for the use of wrote 2.9 million prescriptions in the first older men with erectile problems and for erec- three months of its availability; in the first year tile dysfunction associated with prostate can- alone, over three million men were treated with cer, diabetes, or other medical problems (Loe Viagra, translating into $1.5 billion in sales 2001), Viagra was the first non-invasive med- (Carpiano 2001). Perhaps 200,000 prescripical treatment for male sexual dysfunction. The tions for Viagra are written weekly (Tuller medication operates by increasing the blood 2002), with untold more Viagra sold through flow to the penis, allowing a man to achieve the Internet and other outlets. In 2000, Viagra and sustain an erection when sexually aroused. was ranked 6th in terms of both direct-to-conIngested orally, it takes effect in 30 to 60 min- sumer spending and sales, with a total of $89.5 utes and can last from 4 to 6 hours. million spent and $809 million in sales, and a A demand for a drug for erectile problems 17 percent increase in utilization from 1999 to surely existed before Pfizer began advertising 2000 (NIHCM 2001).



Viagra was a factor in the diagnostic expan- expansion of the concept of male sexual dyssion of sexual dysfunction and the increased function has prompted other companies to medicalization of sexual performance (cf. enter and expand this market, including pharConrad and Potter 2000). Prior to Viagra, med- maceutical companies either developing new ical treatment was largely limited to major dys- drugs to compete with Viagra (Tuller 2002) or functions (e.g., as from prostate surgery). Now seeking a female Viagra (Moynihan 2003; it included mild dysfunctions (e.g., occasional Hartley 2003). Given the aging baby boomers erectile problems) and could be used as an and the entrepreneurial pharmaceutical indusenhancement (Conrad and Potter 2004), offer- trys increased promotion of lifestyle drugs ing a jump start or extra strength for sexual marketed directly to consumers (Mamo and encounters (Loe 2001). Fishman 2001), the medicalization of sexual Viagra is not an inexpensive medication: It dysfunction is likely to continue to expand, at costs about $10 per pill. Within months of the least for the foreseeable future. FDAs approval of the drug, many large insurers (e.g., Kaiser Permanente and Aetna U.S. Healthcare) decided that they would not cover Paxil and Social Anxiety Disorders the drug, except at an extra cost to employers When the FDA approved Paxil (paroxetine or individuals, while others did cover the drug (e.g., Blue Cross/Blue Shield plans in Indiana hydrochloride) for the treatment of depression and California, Harvard Pilgrim Health Care, in 1996, Paxil followed Prozac and several and the Defense Departments health plan). other selective serotonin reuptake inhibitors However, many insurers who currently cover (SSRIs) into an already saturated market for the drug limit the number of pills per month. the treatment of depression. The manufacturer For example, Tufts Health Plan (2002) covers of Paxil (now called GlaxoSmithKline) four tablets every 30 days, and Blue Cross and responded to the saturated depression marBlue Shield of Texas (2003) covers eight ket by requesting FDA approval for additionDelivered by Ingenta to : al applications of Paxil, specializing instead in tablets every 30 days. In Britain, however, the Mr Matharu (cidService 32629), ingenta internal live (cid 75000325), Universitypanic of Delaware the anxiety market, including disorder National Health covers Viagra only for2.3.1/F4 Library 2443) and obsessive compulsive disorder at first, and sexual dysfunction related to conditions such(cid Dec 2005 00:27:44 then social anxiety disorder (SAD) and generas diabetes, prostate cancer, and Tue, renal27 failure (Michael Bury, University of London-Royal alized anxiety disorder (GAD). Paxils application to SAD and GAD has contributed to the Holloway, personal communication). The health insurance industry was involved medicalization of emotions, expanding medin the debate over whether sexual dysfunc- ical jurisdiction over emotions such as worry tion was a medical necessity and whether and shyness. SAD and GAD were fairly obscure diagViagra should be covered by health insurance, resulting in mixed insurance coverage for noses when they were added to the American Viagra. In this case, the insurance industry Psychiatric Associations Diagnostic and attempted to counteract increased medicaliza- Statistical Manual (DSM) in 1980. According tion of male sexual dysfunction by restricting to the DSM-IV, SAD (or social phobia) is a access to Viagra. However, individuals with a persistent and extreme fear of social and perphysicians prescription could of course pur- formance situations in which embarrassment chase the drug on their own or through a range may occur (American Psychiatric Association 1994:411) and GAD involves chronic, excesof Internet sites. One important social benefit from the popu- sive anxiety and worry (lasting at least six larity and widespread use of Viagra is a reduc- months), involving multiple symptoms tion of the stigma of sexual dysfunction. (American Psychiatric Association 1994: Seeing ads for Viagra in so many mainstream 43536). Both conditions are defined as being locations and making Viagra part of everyday associated with significant distress and impairdiscussions has made sexual dysfunction and ment in functioning. Horwitz (2002) notes how its treatment appear conventional and com- small changes in wording of criteria for SAD monplace. This has most likely also increased resulted in a tremendous growth in its estimatthe market for Viagra, since it would be less ed prevalence (and potential market). Marketing diseases and then selling drugs to stigmatizing to inquire about and use it. The success of Viagra and the subsequent treat those diseases is now common in the

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post-Prozac era. Since the FDA approved the its loosely defined boundaries and the aggresuse of Paxil for SAD in 1999 and for GAD in sive marketing of it as a disease: [T]he 2001, GlaxoSmithKline has spent millions of impression often conveyed by commercials for dollars to raise the public visibility of SAD and the drugs is clear: almost anyone could benefit GAD, by sponsoring well-choreographed dis- from them (Goode 2002). Murray Stein, a ease awareness campaigns. The pharmaceuti- psychiatry professor at the University of cal companys savvy approach to marketing California at San Diego, has called the use of SAD and GAD, which relied upon a mixture of prescription medicines such as Paxil, which expert and patient voices, simultaneously are costly and may have significant side gave the conditions diagnostic validity and cre- effects, cosmetic psychopharmacology ated the perception that it could happen to any- (Vedantam 2001:1). Paxils web page one (Koerner 2002). Soon after the FDA ( stresses the elimination of approved the use of Paxil for SAD, Cohn and symptoms (e.g., improved sleep) and improved Wolfe (a public relations firm that was work- performance (e.g., improved ability to coning for what was then SmithKline) began centrate and make decisions) as benefits. putting up posters at bus stops with the slogan, Efforts to define SAD and GAD as condiImagine Being Allergic to People. Later in tions, and market Paxil as treatment for them, 1999, a series of ads featured Paxils efficacy have been extremely successful. Paxil is one of in helping SAD sufferers brave dinner parties the three most widely recognized prescription and public speaking (Koerner 2002:61). drugs, after Viagra and Claritin (Marino 2002), Barry Brand, Paxils product director, said, and it is currently ranked sixth in terms of preEvery marketers dream is to find an uniden- scriptions (Nittan 2001), with U.S. sales of tified or unknown market and develop it. approximately $2.1 billion and global sales of Thats what we were able to do with social anx- $2.7 billion. It is of course not possible to disiety disorder (Vedantam 2001). tinguish how much of this was for SAD or Through media campaigns, GlaxoSmithKline GAD and Delivered by Ingenta to :how much of it was prescribed for redefined SAD GAD, paradoxically, as2.3.1/F4 other (cid problems including depression, obsesMr Matharu (cid and 32629), ingenta internal live 75000325), University of Delaware both common (reducing the stigma associated sive compulsive disorder, or post traumatic Library (cid 2443) with having a mental illness) and abnormal stress disorder. Tue, 27 Dec 2005 00:27:44 (subject to medical intervention, in the form of But there has been some recent backlash Paxil). Prevalence estimates of both SAD and against the drug. In 2002, a federal judge GAD range widely. For example, estimates of ordered a temporary halt to Paxil ads over the the prevalence of SAD range from 3 percent to claim that Paxil is not habit forming (White 13 percent (American Psychiatric Association 2002). Apparently, patients and health care 1994:414), with the National Institute of providers have submitted thousands of reports Mental Health estimating that 3.7 percent of to the FDA describing withdrawal symptoms the U.S. population has SAD (Vedantam (Peterson 2002). Multiple lawsuits have been 2001). Higher prevalence rates are associated filed, asserting that physicians and consumers with less stringent application of the DSM- were misled by advertisements regarding the specified criteria for these conditions.1 severity of withdrawal (Barry 2002). Like simHorwitz (2002) argues that, Because commu- ilarly marketed consumer goods, such as music nity studies consider all symptoms, whether and clothing, it is possible that Paxils popularinternal or not, expectable or not, deviant or ity may be waning. However, along the way, not, as signs of disorder, they inevitably over- the GalaxoSmithKline campaign for Paxil has estimate the prevalence of mental disorder in increased the medicalization of anxiety, inferthe community (p.105). Likewise, the disease ring directly and indirectly that shyness and awareness campaign focused on individuals worrying may be medical problems and that feelings in social situations likely to evoke fear Paxil is the way to treat them. in many people, especially public speaking, and offered consumers symptom-based self tests to assess the likelihood that they had DEVELOPMENT OF PRIVATE MEDICAL SAD and GAD ( This kind of MARKETS clinical ambiguity is fertile ground for creating When treatments or services are not covered an expansive medical market. Some question the validity of SAD, due to by health insurance, but the demand for the

MEDICALIZATION, MARKETS AND CONSUMERS medical service or treatment remains, a private medical market may evolve. Private medical markets emerge when an available medical interventionfrequently 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 treatment, 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 enhancements and technology are illustrated through two cases: the use of human growth hormone for idiopathic shortness and in vitro fertilization for infertility.


approved by the FDA only for treating hypopituitary dwarfism (or growth hormone deficiency) and chronic renal failure. While individual 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 idiopathic short stature, that is normal children who were of short stature but had no deficiency 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 inches or less; for adult females it is 59.5 inches (NHANES 2000). It is estimated that 1.8 million children in the United States and a similar number in Europe can be characterized with Human Growth Hormone and Idiopathic significant short stature. Only 20 percent of Delivered by Ingenta to referred : Short Stature these are to pediatric endocrinologists Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cid 5 75000325), University Delaware and only percent of these are of growth horLibrary 2443) Medications are frequently prescribed for(cid mone deficient (Hintz 1996). The vast majoriTue, 27 Dec 2005 00:27:44 off-label uses, as treatments of conditions ty of short children therefore can be considered beyond those approved by the Federal Drug idiopathic short stature, defined as a heteroAdministration. While physicians, in practice,2 geneous state that encompasses individuals have autonomy and authority to prescribe for with short stature, including those with FSS off-label uses of a drug, manufacturers cannot (familial short stature), for which there is no legally market for off-label uses. recognized cause (Kelnar et al. 1999:151). Prior to 1985, human growth hormone The causes of short stature may well be familextracted from cadavers was used to treat indi- ial (short parents), genetic, or nutritional, but it viduals who had a growth hormone deficiency. can be seen as normal shortness as opposed The growth hormone was in low supply and to more specific deficiency shortness. thus very expensive and carried severe risks of A national survey of 534 pediatric endocriCreutzfeldt-Jacobs disease, a potentially fatal nologists documented that 94 percent of them brain disease. In 1985 the FDA removed it had prescribed human growth hormone within from the market. With fortuitous timing, the previous 5 years for children who were not Genentech introduced an FDA approved syn- hormone deficient (Cutler et al. 1996:532). thetic human growth hormone within six Genentech and, to some extent, Eli Lilly (who months of the removal of cadaver-extracted marketed a similar hormone) worked closely growth hormone. The recombinant hormone, with the Human Growth Foundation, a nonmarketed as Protropin, could be produced in profit advocacy group that supported short potentially unlimited quantities (Lantos et children (Werth 1991), a more general term al. 1989:1020) to such an extent that physi- including both hypopituitary dwarfism and cians credited the new technology with ending idiopathic short stature. Genentech also supthe market shortage of the hormone ported research by pediatric endocrinologists (Glasbrenner 1986). Genentech soon claimed and began its own longitudinal research on 75 percent of the existing $200 million U.S. healthy children who were not hormone market (Werth 1991). The hormone had been deficient. These activities further blurred the

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boundaries demarcating legitimate and off- eased limitations upon manufacturers, broadlabel use of human growth hormone.4 In ening the information that they may provide to 2003, the FDA approved Eli Lillys Humatrope physicians about off-label use of their products to treat idiopathic short stature children in the (Stapleton 1999). In terms of shortness, the shortest 1.2 percent of the population, which potential market is considerable, with nearly will likely accelerate its use in potentially short four million children in the United States and children (Kaufman 2003). Europe who could be defined as having idioThere is some evidence that shortness (and pathic short stature. This could further increase especially extreme shortness) often is a deval- the medicalization of short stature. ued status and can have social consequences, especially for males. Some researchers have found social disadvantages of shortness, In Vitro Fertilization and the Medical including discrimination in hiring and salaries, Treatment for Infertility assumptions regarding maturity and compeThe development of reproductive technolotence, issues around self-esteem and perceived attractiveness, and practical problems such as gies has resulted in the medicalization of inferbuying well-fitting clothes (see Conrad and tility. In vitro fertilization (or IVF), in which Potter 2004). Whatever the real or imagined eggs are abstracted and fertilized and then disadvantages of shortness, some parents have implanted inside a womans uterus, is one such anxieties about their childrens height. With the case. When it was first practiced successfully, availability of synthetic human growth hor- resulting in the conception of the first test mone, parents could consider interventions tube baby in 1978, in vitro fertilization held that would influence the height of their chil- out hope of a technological fix to an estimated 7 percent of couples who experience dren. At least 13,000 children in the United States infertility (Centers for Disease Control 2001). Persons perceive that not only can the with idiopathic short stature were treated with Delivered by Ingenta to now : source of infertility be University diagnosed,of but it can be Research on2.3.1/F4 human growth hormone in 1994.5 internal Mr Matharu (cid 32629), ingenta live (cid 75000325), Delaware treated growth hormone treatment with idiopathic Library (cid 2443) (Scritchfield 1995:139), and assisted reproductive short children has been equivocal.Tue, It is27 debatDec 2005 00:27:44 technology has transformed able how much treatment can increase growth infertility into a clinical need (Bates and from predicted height (cf. Hintz 1996). One Bates 1996:301). Yet the medical market for in vitro fertilizamajor multi-center study, sponsored by Genentech, reported that of the 80 individuals tion has remained fairly constrained because in the study who reached final height, the many consumers do not have insurance covermean gain from predicted height was 5.9 cen- age for in vitro fertilization (Neumann 1997). timeters in girls and 5.0 centimeters in boys One study found that a minority of plans (14 to (Hintz et al. 2000). The height gains are mod- 17 percent, depending upon the type of plan) est; human growth hormone will not transform cover in vitro fertilization (Alan Guttmacher a short person into a tall one, but only into a Institute 1993), and another study found that less short one. Human growth hormone treat- 30 to 40 percent of in vitro fertilization serment costs about $20,000 a year and must be vices are covered partially and that insurance continued for three to six years. Parents of reimburses for about half of the costs when in idiopathic short stature children must pay this vitro fertilization is covered (Collins et al. out of their own funds, since health insurance 1995). At first, health insurers justified their will only cover treatment for hormone defi- exclusion of IVF from coverage on two ciency. If the average height gain is two inch- grounds: efficacy and cost. Initially, success es, and the average cost is $100,000, the cost of rates were estimated to be 1520 percent per height enhancement is roughly $50,000 an attempt (Kolata 1983), and recent estimates of success rates range from 32.2 percent for inch. The relative ease with which manufacturers women under 35 years to 9.7 percent for may promote and physicians may prescribe women ages 4041 (Centers for Disease human growth hormone for off-label treatment Control 2001). Insurance companies have has increased the range of possible uses often labeled in vitro fertilization as experi(Conrad and Potter 2004). The Federal Drug mental, as a result of these relatively low sucAdministration Modernization Act of 1997 cess rates. In vitro fertilization is also a fairly

MEDICALIZATION, MARKETS AND CONSUMERS 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 carriers provided coverage for assisted reproductive technology when it first became available but dropped that benefit (Lang 1998) or decided to charge extra for in vitro fertilization coverage (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-ofpocket, using their savings and going into substantial 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:


dren (American Society for Reproductive Medicine 2002). Earlier cases in which consumers 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 fertilization 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). Im tapped out, mortgaged out, credit-cardRegarding infertility as an illness, some argue ed out. And we were lucky. We got our that infertility is sought by some couples and babies. We still live in a one-bedroom apartment. We had a nest egg when we got suffered by others. Therefore, it is a socially married; we had health insurance, and the constructed neednot a medical need (Bates system wasnt there for us (Lang 1998:12). and Bates 1996:301). Nonpregnancy is not an Facing looming personal debt from infertili- illness. Some insurers have argued that inferDelivered by Ingenta to : ty treatment and substantial resistance from tility treatment is elective and does not cure Mr Matharu (cid 32629), ingenta internal class live 2.3.1/F4 (cid 75000325), University of1994). Delaware health insurers, middle and upper-middle any sickness or disease (Tischler The Library 2443) necessity argument has been used to consumers have turned to litigation and legis-(cid medical Tue, 27 Dec 2005 00:27:44 lation as means of gaining rights to reimburseexclude in vitro fertilization from coverage by ment for in vitro fertilization. These couples drawing attention to the social aspects of inferhave made a claim upon society to guarantee, tility and uses of IVF. Some contend that this through whatever means possible, the capacity argument is used to control in vitro fertilizato reproduce (Blank 1997:281). Thus far, nine tions fiscal impact on insurers (Hughes and states have passed legislation regulating health Giacomini 2001), restricting the use of in vitro insurance coverage of in vitro fertilization in fertilization to a small number of cases in response to advocacy efforts by groups such as which the source of infertility problems can be Resolve (the largest fertility support group in specifically pinpointed and addressed. For the United States). Recently, there have also example, the use of in vitro fertilization to been some calls for federal legislation to pro- bypass blocked or damaged fallopian tubes is a tect the insurance rights of infertile couples very specific, medical use of the technology. (McKee 2001). The use of in vitro fertilization to address Consumers have also sought health insur- infertility associated with age or to help single ance coverage for in vitro fertilization through or lesbian women have biological children is the courts, claiming that infertility is an illness more social. This medical necessity argument or a disability, but such attempts have had only has had some success in the courts (e.g., limited success. In this arena, consumers and Kinzie v. Physicians Liability Insurance insurers have wrestled over the medicalization Company 1987). of infertility and over in vitro fertilization as a Even with a few successful court cases, treatment for infertility. The position that infer- insurers in general have not accepted contility is a disease is supported by the American sumers claims that infertility is a disease or Society for Reproductive Medicine, which disability and have not increased coverage. As states that, infertility is a disease of the repro- a result, many consumers must still pay out-ofductive system that impairs one of the bodys pocket for in vitro fertilization services, and most basic functions: the conception of chil- some fertility clinics have turned to creative

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financial arrangements to increase the private mitted (e.g., for off-label uses), corporations market for their services. These arrangements promote indirectly to providers or consumers offer money-back guarantees or substantial (e.g., on the Internet). Consumers are the refunds if patients do not get pregnant or if prime driver for demand, generally without they miscarry early in the pregnancy insurance support, and must pay directly for (Hamilton 1996; Wilcox and Rossi 2002; medical products or services. Physicians are necessary facilitators for treatment but are Wozencraft 1996). The private market for in vitro fertilization sometimes promoters (i.e., entrepreneurs) for appears to be here to stay. Physicians are drawn the product as well (e.g., cosmetic surgery). There may be a tension between restricted to reproductive medicine because of the cutting edge nature of the work, as well as the access to health care and the expansion of potential for commercial profit (Brody 1987). mediated and private markets. Private markets In vitro fertilization clinics advertise using tend to emerge when insurers define a problem Internet websites with links to finance compa- or treatment as not medically necessary and nies to help pay for the procedure. Consumers therefore not subject to third party reimbursewho wish to have biological children are drawn ment. Thus insurers here attempt to constrain to technological solutions to infertility. Yet the access to medicalized solutions by refusing to consumer demand for in vitro fertilization and cover particular treatments or services. These other reproductive technologies is constrained markets are not fixed; given changes in proby insurers refusals to pay for such services, motion, insurance coverage, or consumer role, except under specific medical circum- private markets could become mediated marstances. This has resulted in the creation of a kets and vice versa. In operation, such markets private medical market for consumers who can are more on a continuum than mutually excluafford to pay for in vitro fertilization or who sive in their attributes. A key to all markets is the existence of a are willing to take on significant debt to do so. medical and consumer demand. In Delivered by Ingenta to product : Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4 75000325), University of companies Delaware some (cid cases, the pharmaceutical Library (cid 2443) strategies to expand their markets DISCUSSION develop Tue, 27 Dec 2005 00:27:44 (e.g., Viagra and Paxil), while in others the We have described four cases where the markets are more consumer-driven. Table 2 development of medical markets facilitated outlines the different modes of promotion and medicalization, and we have identified two their relation to medicalization. forms of medical markets: mediated and priIn two cases the development of medical vate markets. We outline the main attributes of markets is primarily corporate driven. Viagra these markets in Table 1. In mediated markets, and Paxil are promoted by pharmaceutical corporate medical producers attempt to companies through direct-to-consumer adverincrease demand for their products by promot- tising, but the goals and means differ. With ing directly to consumers and providers, with Viagra, the goal is to increase the appeal of the the market mediated by health insurers and product to a wider population. When first managed care organizations. Consumers introduced, Viagra was aimed at older men or become the target for market expansion, with others with established erectile dysfunction. physicians largely remaining as gatekeepers However, in recent years much of the advertisprescribing treatment.6 In private medical mar- ing has been aimed at a younger and broader kets, due to limits in types of promotion per- population, with the implicit message that
TABLE 1. Comparison of Mediated and Private Markets
Relation to Corporate Insurers Consumers Physicians Mediated Markets Private Markets Direct promotion to providers and consumers Indirect promotion to providers via off-label (direct-to-consumer advertising) use or consumers on the Internet Problem is generally covered by insurance with Problem is not covered relatively flexible criteria by insurance or only covered under strict medical criteria Targeted for market expansion Promoter of market expansion Gatekeeper, with authority to define problem Facilitator, with authority to define problem and prescribe treatment and prescribe treatment


TABLE 2. Promotion of Medical Markets and Medicalization
Product Viagra Paxil Promoter Corporate Driven Corporate Driven Goal Create new populations for product Means Direct-to-consumer advertising to younger and virile types Create new problems for Direct-to-consumer disapproved product ease awareness campaign Expand product to non- Secure off-label use of FDA approved uses product Redefine infertility into a health problem so technology is covered by health insurance Seek right to treatment through legislation and litigation


Medicalization Expands diagnosis of erectile dysfunction Promotes disorders of SAD and GAD Makes short stature into a medical problem Further medicalizes infertility

Human Consumer and Growth Corporate Driven Hormone In Vitro FertiliConsumer Driven zation

Viagra can help them too with whatever sexual/ to achieve medical legitimacy for all kinds of performance problems they may have. This infertility so that third parties will pay for market expansion means offering a medical treatment. When human growth hormone for solution to a wider range of mild or transitory idiopathic short stature and in vitro fertilizaerectile problems. The promoters of Paxil, on tion for infertility are not covered by health the other hand, want to differentiate their drug insurers, consumers must pay for these serfrom others on the market. After getting FDA vices out-of-pocket, creating a private medical approval for new uses, GlaxoSmithKline market. This type of market has all the characdeveloped a direct-to-consumer disease teristics of any private market: Those who can awareness campaign to alert consumers afford to pay can acquire the services. that they might have a diagnosable problem Medical markets can change, based upon (e.g., SAD) and that Paxil could be the right whether deem the product to be a Delivered by Ingenta to insurers : choice for them. This encourages people to medical necessity and cover a service or drug. Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cid 75000325), University of Delaware redefine their life difficulties in medical terms(cid The in vitro fertilization debate clearly turns Library 2443) 27 Dec 2005 and creates a further demand for Tue, the product. on 00:27:44 whether infertility treatment is medically In both cases the advertising aims to increase necessary; consumers say it is and should be the consumer demand for the medical treat- covered by insurance while insurers claim havment product. Increased medicalization is a ing children is a social choice, not a medical by-product. one. We see medical necessity reflected in the Human growth hormone can be seen as human growth hormone and Viagra cases as jointly corporate and consumer driven. While well, even if the term is not typically applied. there was no direct corporate product advertis- Consumer advocates claim that human growth ing to consumers, Genentech had to pay a $50 hormone is a medical necessity since medical million settlement for overpromoting human treatment could mitigate the suffering, stigma, growth hormone to medical practitioners for and discrimination due to the biological limitatreating unapproved conditions (including tion of extreme shortness. Is the treatment of idiopathic short stature) (Nordenberg 1999). It erectile dysfunction a medical necessity? In is unclear how much the promotion to doctors terms of insurers, the answer is, sort of. and hospitals stimulated the development of When insurers cover the cost of Viagra, they the medical market for growth hormone, but is often limit it to four to eight pills a month. safe to assume it had some effect. Genentech Does this mean sexual intercourse is a medical and other pharmaceutical companies support necessity four to eight times a month? consumer groups that promote hormone interIt is also possible to see some uses of human ventions for idiopathic short stature, but con- growth hormone, Viagra, Paxil and in vitro fersumer groups are the primary advocates for tilization as biomedical enhancements rather human growth hormone treatment (Conrad and than treatments. While there are certainly medPotter 2004). For in vitro fertilization, con- ically legitimated uses for each of these drugs sumers are the main proponents pressuring for and procedures, some uses may constitute insurance coverage. Through organizations, lit- enhancement rather than treatment. igation, and legislation, consumers are striving Biomedical enhancements are medical inter-

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ventions used to improve physical or mental Physicians in the past have provided prescripcharacteristics or performance in those with no tions in response to patients direct requests, identifiable pathology. Adding a few inches of even when the scientific knowledge suggested height to ones child, insuring strong erections, that it was not appropriate, because they worincreasing ones social abilities, or having a ried about economics and their professional biological child might all be improvements image and because they wanted to respond to that could be sought by many individuals. One patients requests for help (Schwartz, need not have a disorder to benefit from these Soumerai and Avorn 1989). But direct-to-conmedical interventions. Peter Kramer (1993) sumer advertising has increased consumers claimed that Prozac can make people better role in the prescribing equation. While physithan well. There has been some debate in the cians remain the gatekeeper to these drugs, bioethics literature about a distinction between reflected in most direct-to-consumer ads endtherapy and enhancement, but medicalizing ing with a statement like, ask your doctor if human problems creates a slippery slope Paxil [or Viagra] is right for you, there is between enhancement and legitimated medical increased pressure to respond to consumers treatment (Conrad and Potter 2004). independent requests for medications. In the While erectile dysfunction, anxiety, short context of current debates regarding chalstature, and infertility surely can impact peo- lenges to physicians professional knowledge ples lives to varying degrees, they are not life- (Timmermans and Kolker 2004), it appears threatening conditions nor even major health that pharmaceutical manufacturers are circumrisks. Anti-hypertensive or cholesterol reduc- venting physicians control over knowledge ing drugs associated with cardiovascular dis- regarding available drugs. ease are also widely promoted, but for a well Insurers as payers exert a strong influence established medical problem. While prevention on medical markets. In the context of the of disease is a major market for drugs and examples presented here, insurers including interventions, the relatively common problems Delivered by Ingenta HMOs to set :the limits on some medical markets, of on the margins of medicine, holdlive the2.3.1/F4 (cid 75000325), University of Delaware Mrlife, Matharu (cid 32629), ingenta internal thus acting as a constraint on access to medgreatest potential for market expansion and (cid 2443) Library icalized solutions to human problems. This is medicalization. Tue, 27 Dec 2005 00:27:44 particularly clear with in vitro fertilization, The role of physicians as providers is where insurers definition of the treatment as changing in the current medical marketplace, with some areas shifting more than others. experimental and their refusal to cover it With off-label uses of drugs like human except in very specific diagnostic situations growth hormone for idiopathic short stature, has limited in vitro fertilization to those who physicians play a facilitating role in the mar- could afford to pay for it. Insurers will only pay ket. It is a physicians prerogative to prescribe for human growth hormone for children with a medications for uses beyond those approved by diagnosed growth hormone deficiency; idiothe FDA. Doctors commonly prescribe drugs pathic short stature children only receive treatfor unapproved uses if, in their judgment, the ment if their families can pay for it. Few can drug would be an effective treatment for a afford the tariff. Even with Viagra, some insurpatients problem. Similarly, technical inter- ance plans dont cover this treatment for erecventions such as in vitro fertilization would be tile dysfunction, while others limit the use. It totally unavailable without physician involve- has long been an axiom in medicalization studment. Thus physicians still have an important ies that the only way to get human services central role in facilitating medical markets, paid for is to turn life difficulties into medical problems. Yet under managed care insurers are especially in private markets. But the physicians role is challenged on responding to this medicalization by restricting other fronts, particularly with direct-to-con- payment for these services. Insurance consumer advertising undermining physicians straints do not necessarily affect the conceptuauthority regarding which drugs to prescribe. al level of medicalization but they constrain Physicians have always been the major conduit access to medicalized solutions at the patient between the pharmaceutical industry and level (Conrad and Schneider 1980)7. By patients (which is why the pharmaceutical restricting access to medical solutions in the industry spends billions of dollars advertising name of medical necessity, insurers attempt and promoting their wares to physicians). to limit individuals claims that they are suffer-



ing from illnesses rather than everyday life Manufacturers will likely promote off-label (Sabin and Daniels 1994). applications to the extent legally permitted, Consumers have a dual role related to med- perhaps expanding diagnoses (Conrad and ical markets. In some instances the market for Potter 2000) and further medicalization.8 a problem exists long before any medical proMedicalization narrows the definition of motion. Individuals have been seeking nos- health and widens the definition of sickness. trums to improve sexual performance or votive The direct-to-consumer advertising focuses on objects to insure fertility for centuries, while help seeking advertisements (Lyles 2002), short people have often tried to appear taller which try to create an awareness of symp(think elevator shoes and high heels). In a toms or conditions among consumers. sense, there is a ready-made market demand Consumer education campaigns are used to for a product. Consumers and medical interests introduce new products or extended applicaare already allied, and consumers may become tions, essentially bringing new people into a the dynamic force for market creation. In other market by creating a previously unrecognized cases, the public constitutes potential con- demand for a product (Applbaum 2000). The sumers who must be shaped into a market. This marketing of Viagra expands the bounds of involves persuading consumers of the necessi- erectile dysfunction, implying that it is not ty or utility of a product offered or creating healthy or normal to have variation in consumer demand. Direct-to-consumer adver- penile erections. Paxil ads emphasize that it tising for Paxil exemplifies this, although it is may be pathological to be anxious or shy in partly true for Viagra as well. Such promotion social situations and that this can be changed can induce people to self-label their problems by using the drug. Employing human growth as medical entities and seek more medical ser- hormone to treat short stature indicates a narvices. This medical commodification shifts rowing of the range of normal height as well as both definition and solution into the medical reinforcing the notion that shortness is deviant sphere. and undesirable, and that it should be altered. Delivered by Ingenta to : Recent changes in FDA regulations allow The marketing of Paxil, Viagra and, to a lesser Mr a Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cid 75000325), University Delaware for different kind of drug marketing by loosdegree, human growth hormone of targets relaLibrary 2443) ening off-label provisions and enabling televi-(cid tively healthy people. Drug companies search Tue, 27 Dec 2005 00:27:44 sion advertising of prescription drugs, facilifor markets creates broader disease definitions tating the emergence of new medical markets. for their products, indirectly reducing what is Broadcast ads can now name the disorder and normal. the drug, so long as they include limited risk and benefit information (Lyles 2002). As noted, corporate pharmaceutical spending on CONCLUSION television advertising increased six-fold from We highlight the increasing importance of 1996 to 2000, and ads for products such as pharmaceutical companies, insurers, and conPaxil and Viagra have become common. Off-label uses of FDA approved drugs is one sumers for medicalization as they are involved of the easiest routes to the expansion of med- in the creation of medical markets. The medical markets. Once a drug has been approved ical profession has a diminished but still key for one use or population, it can be prescribed role in medicalization. Given the changes in for broader purposes. Ritalin is approved for medicine and its organization, important arechildhood ADHD, but for the past decade it has nas of medicalization are moving from profesbeen used widely with adults (Conrad and sional to market domains. It is not new knowledge or technology that Potter 2000). Provigil (modafinil) is approved for sleep disorders, such as narcolepsy and engenders medicalization but how they are hypersomia, but in its direct-to-consumer used. Corporate and medical promotion of advertising, Cepahlon, the manufacturer, has products, treatments, and drugs underlies the touted that the drug can drastically reduce the emergence of new medical markets. With our amount of sleep required without affecting corporatized medical-industrial complex, the performance (Wolpe 2002). While drug com- creation or expansion of medical markets panies have been limited in their advertising becomes an important conduit to medicalizafor off-label uses, FDA regulations allow for tion. Consumer demand is not simply unfetconsiderably more latitude in promotion. tered desire for medical solutions, but it is

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shaped by the availability and accessibility of medical interventions. This creates a new set of relationships among corporate entities, insurers, physicians, and consumers. In the context of the changing balance of power among the medical profession and related institutions, the engines of medicalization are found in the marketplace nexus of the biotechnology industry and rising consumerism. The brakes take the form of insurers, including private and government sponsored 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 medicalize the troubles and problems of everyday life.

terion that has produced the most controversy (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, marketing 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 medical conditions for which it did not have FDA approval (Nordenberg 1999:33). From 1985 to 1994, Genentech marketed Protropin to a variety of medical practitionNOTES ers (doctors, hospitals, and others) for treating unapproved conditions, including idio1. According to the DSM, the diagnostic critepathic short stature (Nordenberg 1999). ria for SAD include: a marked and persisGenentech paid $50 million in settlement, tent fear of social or performance situations including a $20 million penalty to reimin which embarrassment may Delivered occur, an burse and CHAMPUS by Ingenta to : Medicaid anxiety response, recognition (Nordenberg 1999).University of Delaware Mrimmediate Matharu (cid 32629), ingentaainternal live 2.3.1/F4 (cid 75000325), that the fear is excessive or unreasonable, 5.2443) This is an extrapolation. In 1994, about Library (cid avoidance of the situation or endurance children were believed to suffer from Tue, 27 Dec 2005 7,000 00:27:44 with dread, interference with daily routine short stature due to human growth hormone or marked distress about the phobia, and the deficiency but 20,000 children were treated fear not being due to substance effects or with human growth hormone (Biotechology other conditions (American Psychiatric News, 1994). Therefore at least 13,000 chilAssociation, 1994:411). dren were treated for idiopathic short 2. Professional medicine has long approved of stature that year. off-label uses of drugs. In 1999, the 6. There is increasing advertising on the American Medical Association approved a Internet for Viagra, human growth horposition statement (Resolution #528), intromone, and other prescription medications. duced by the Society of Cardiovascular and While it is assumed that a doctor must evalInterventional Radiology, on off-label use uate the short forms consumers need to of devices and medications. In summary, complete before ordering medications, the the AMA permits physicians to decide what wide availability of medications through the to prescribe for their patients and for what Internet sources compromises the physimedical conditions, because physicians are cians gatekeeper role. best able to base these decisions on current 7. Some have suggested that direct-to-conclinical standards and not just FDAsumer advertising is in part a reaction to approved indications. managed care. Lyles (2002) notes that, 3. Criteria include (1) height of less than three managed care controls that limit the physistandard deviations below the mean for a cians prescription authority also reduce the childs age and sex, (2) abnormal growth potential of promotional activities targeting velocity (less than 25th percentile for bone physicians; consequently pharmaceutical age), and (3) growth hormone provocative companies have responded by seeking altertesting results with peak growth hormone of native ways to influence physician prescribless than10 (g/L in a polyclonal radioiming (p. 27). munoassay (Bercu 1996). It is this latter cri- 8. A recent case illustrates this. Parke-Davis, a

MEDICALIZATION, MARKETS AND CONSUMERS 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 doctors for social phobias, panic disorder, bipolar 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 percent 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).


Blank, Robert H. 1997. Assisted Reproduction and Reproductive Rights: The Case of In Vitro Fertilization. Politics and the Life Sciences 16:27988. Blue Cross and Blue Shield of Texas. 2003. Quantity Versus Time Limits List. Retrieved August 25, 2004 ( provider/pdf/qvtdruglist.pdf). Bonaccorso, Silvia N. and Jeffrey L. Sturchio. 2002. Direct to Consumer Advertising is Medicalizing Normal Human Experience: Against. British Medical Journal 324:91011. Brody, Eugene B. 1987. Reproduction without SexBut with the Doctor. Law, Medicine and Health Care 15:1525. Carpiano, Richard M. 2001. Passive Medicalization: The Case of Viagra and Erectile Dysfunction. Sociological Symposium 21: 44150. Centers for Disease Control. 2001. 1999 Assisted Reproductive Technology Success Rates. REFERENCES Washington, DC: Centers for Disease Control. Clarke, Adele E., Janet K. Shim, Laura Mamo, Jennifer Ruth Fosket, and Jennifer R. Fishman. Alan Guttmacher Institute. 1993. Uneven and 2003. Biomedicalization: Technoscientific Unequal: Insurance Coverage and Reproductive Transformations of Health, Illness, and U.S. Services. New York: Alan Guttmacher Institute. Biomedicine. American Sociological Review American Psychiatric Association. 1994. 68: 16194. Diagnostic and Statistical Manual of Mental Disorders, 4th ed.. Washington, DC: American Cohen, David, Michael McCubbin, Johanne Collin, Delivered by Ingenta : and to Gilhme Prodeu. 2001. Medications as Psychiatric Association. Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cidPhenomena. 75000325), Health University of Delaware Social 5:44169. American Society for Reproductive Medicine, Library 2443) J. A., M. Bustillo, R. D. Visscher, and L.D. Collins, Ethics Committee. 1998. Shared-risk or Refund(cid Tue, 27 Dec 2005 00:27:44 Lawrence. 1995. An Estimate of the Cost of In Programs in Assisted Reproduction. Fertility Vitro Fertilization in the United States. Fertility and Sterility 70:41415. and Sterility 64:53845. American Society for Reproductive Medicine. 2002. Frequently Asked Questions About Conrad, Peter. 1992. Medicalization and Social Control. Annual Review of Sociology Infertility. Retrieved August 25, 2004. 18:20932. (http:/ Angell, Marcia. 2000. The Pharmaceutical Conrad, Peter. 1997. Public Eyes and Private Genes: Historical Frames, News Constructions, Industry: To Whom is it Accountable? The New and Social Problems. Social Problems England Journal of Medicine 342:19021904. 44:13954. Applbaum, Kalman. 2000. Marketing and Conrad, Peter. 2000. Genetics, Medicalization and Commodification. Social Analysis 44:10628. Human Problems. Pp. 32233 in The Handbook Barry, Ellen. 2002. Mass. Group Sues Paxil of Medical Sociology, 5th ed, edited by Chloe Drugmaker. The Boston Globe, October 26, p. Bird, Peter Conrad and Alan Fremont. Upper A3. Saddle River, NJ: Prentice Hall. Barsky, Arthur J. and Jonathan F. Borus. 1995. Somatization and Medicalization in the Era of Conrad, Peter and Deborah Potter. 2000. From Hyperactive Children to ADHD Adults: Managed Care. Journal of American Medical Observations on the Expansion of Medical Asssociation 274:193134. Categories. Social Problems 47:55982. Bates, G. William and Susanne R. Bates. 1996. Infertility Services in a Managed Care Conrad, Peter and Deborah Potter. 2004. Human Growth Hormone and the Temptations of Environment. Current Opinion in Obstetrics Biomedical Enhancement. Sociology of Health and Gynecology 8:300304. and Illness 16:184215. Bercu, Barry B. 1996. The Growth Conundrum: Growth Hormone Treatment of the Non-growth Conrad, Peter and Joseph W. Schneider. 1980. Looking at Levels of Medicalization: A Hormone Deficient Child. Editorial. Journal of Comment on Strongs Critique of Medical the American Medical Association 276:56768. Imperialism. Social Science and Medicine Biotechnology Business News. 1994. Efficacy of Growth Hormones Questioned in US. October 14A:759. 24. Conrad, Peter and Joseph W. Schneider. [1980]

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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.

Delivered by Ingenta to : Mr Matharu (cid 32629), ingenta internal live 2.3.1/F4 (cid 75000325), University of Delaware Library (cid 2443) Tue, 27 Dec 2005 00:27:44