Women Sexuality-Discussion

Abstract This essay will describe how the success of Viagra stimulated drug companies to create a women’s sexual condition comparable to erectile problems in men for which they could market new sex drugs to women. The heart of the article focuses on two interrelated aspects of Viagra culture playing out in drug industry efforts to create and expand a market for sex drugs for women: (1) the industry’s ‘Hunt for the Pink Viagra’ to treat the ‘disease’ of female sexual dysfunction (FSD), and (2) the prescription and promotion of off-label uses of men’s sex drugs to women. In order to contextualize these two trends, the article outlines key activities and actions that have enabled the drug industry to consolidate power and build capacity in this area, including: mass dissemination of estimates of disease prevalence; the institutionalization of FSD in academic circles, which includes strategic revision of disease definitions as well as the creation of a legitimized infrastructure for dissemination of supporting research and education; and public-relations stimulated mainstream media coverage. The article concludes with a consideration of the ongoing challenges to the medicalization of women’s sexuality as well as to harmful corporate practices more broadly.

Keywords female sexual dysfunction (FSD), medicalization, off-label prescriptions, pharmaceutical industry, Viagra

Heather Hartley Portland State University, Oregon, USA

The ‘Pinking’ of Viagra Culture: Drug Industry Efforts to Create and

Repackage Sex Drugs for Women

The year 2003 marked both the 5th anniversary of Viagra’s launch and the release of two prominent new competitors to Viagra’s multi-billion-dollar annual market share: Levitra and Cialis. The makers of these products, Bayer HealthCare Pharmaceuticals/GlaxoSmithKline (Levitra) and Lilly ICOS (Cialis) promote the ideology that more is better. Both products are

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advertised as ‘lasting longer’ than Viagra, with Cialis even nicknamed ‘the weekender’ because of its alleged 36-hour range of effectiveness. In general, of course, the pharmaceutical industry embraces the philosophy that ‘more is better’, especially when the topic is profit. The success of the blockbuster drug Viagra – and the concomitant spread of a ‘Viagra culture’ – prompted the industry both to develop other drugs to treat male sexual problems, and served as an incentive for it to espouse a medical approach to women’s sexual problems and develop new sex drugs to treat those problems. Just as happened with men’s problems, women’s sexual problems became increasingly medicalized – defined and under- stood as a largely physiologically based set of conditions called ‘female sexual dysfunction’ (FSD).

That the annual market for medical treatments for women’s sexual woes is estimated at about $1.7 billion creates tremendous incentives for pharmaceutical companies to develop a specific, FDA-approved ‘Viagra for women’ (Leland, 2000). At the time of writing (January 2006), despite a huge outlay of expense and effort, there is no drug approved for FSD – currently, the only FDA-approved prescription treatment is a mechanical clitoris-stimulator called EROS-CTD. Proctor and Gamble’s testosterone patch, Intrinsa, was the first (and so far, only) drug to be considered by the FDA, and it did not receive FDA-approval. But a variety of other products for women – pills, patches, creams, sprays – are being developed and tested by over a dozen pharmaceutical companies (Enserik, 2005).

The heart of this article focuses on two interrelated aspects of Viagra culture playing out in drug industry efforts to create and expand a market for sex drugs for women. These industry efforts concentrate along two main strategies: (1) a ‘hunt for the Pink Viagra’ to treat the ‘disease’ of FSD, the chronology of which involved an almost unnoticed shift from development of products to treat arousal problems to those intended for desire problems, and (2) the increasing promotion and normalization of off-label uses of men’s sex drugs for women.

Since the late 1990s, the drug industry has increased its power to shape definitions of women’s sexual problems and has built institutional capacity enabling it to develop and promote sex drugs for women. Events and activities of particular significance include the mass dissemination of esti- mates of disease prevalence; the institutionalization of FSD in academic circles; and public-relations stimulated mainstream media coverage.

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Industry consolidation of power and building of capacity Inflated epidemiology promotes a medicalized view of women’s sexuality No accounting of drug industry interest in FSD would be complete without reference to the ‘43–31’ study, shorthand for the widely-cited study published in JAMA (Journal of the American Medical Association) that concluded that more than 4 out of 10 women (43%) have sexual problems, a rate of sexual dysfunction higher than that of men (31%) (Laumann et al., 1999). The critiques of this statistic are widespread (see Moynihan, 2003a), and even Laumann himself has gone on record saying his findings were appropriated to promote the medicalization of sexual problems (O’Connor, 2005), yet both mass media and professional litera- ture constantly cite this figure. The pharmaceutical industry in particular has used this ‘inflated epidemiology’ to expand a medicalized perspective on women’s sexual problems (Tiefer, 2002). Subsequent studies indicat- ing lower prevalence rates and supporting social-psychological rather than physical factors as primary determinants of women’s sexual problems (e.g. Bancroft, 2002; Bancroft et al., 2003) receive almost no media attention.

The institutionalization of FSD FSD has become institutionalized in academic circles in a manner that solid- ifies pharma-medical control over the naming and treatment of women’s sexual problems. Key milestones in the institutionalization process include: development of systems of disease classification amenable to medical approaches; creation of a legitimized infrastructure for disseminating supporting research and education; formation of an attendant professional organization; and establishment of an appropriate medical specialty.

The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM) is the most widely used system for classifying women’s sexual problems, specifying four categories: lack of desire, lack of arousal, pain during intercourse, and lack of orgasm (APA, 1994; see Tiefer, 2004 for a critique). In 1998, a consensus conference, consisting of a group of 19 sexuality researchers and clinicians (18 of whom had financial ties to the pharmaceutical industry) was convened to revise the DSM nomenclature. Ultimately, the system was revised in a manner that facilitates a platform for a new area of physical medicine (for details, see Basson et al., 2000; Tiefer, 2000b).

An annual continuing medical education (CME) conference sponsored by the Boston University School of Medicine (Department of Urology) from 1999 to 2001 played a key role in institutionalizing the medically- oriented perspective on FSD (Moynihan, 2003a). The CME context

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provided a legitimized infrastructure for the dissemination of research and education that, in general, promoted a biomedical perspective on sexual problems (Hartley and Tiefer, 2003; for critique of the increasing role of the pharmaceutical industry in medical research and education, see Abramson, 2004; Angell, 2000a, 2000b, 2004; Bodenheimer, 2000; Kassirer, 2005; Moynihan, 2003a; Relman, 2001; Tiefer 2000a). These first three Boston meetings inaugurated an annual conference that soon became international (the conference convened in Canada in 2002, the Netherlands in 2003, the USA in 2004 and 2005, and Portugal in 2006). And it was at these first Boston meetings that participants voted to establish a professional organization, first called the Female Sexual Function Forum (FSFF) in 2000, and renamed the International Society for the Study of Women’s Sexual Health (ISSWSH) in 2001 (Hartley, 2003).

Dr Irwin Goldstein chaired the three Boston meetings, and his high profile at these events helped him to secure funds (and legitimacy) to open the nation’s first academic sexual medicine department in Fall 2002 at Boston University, where the research focused heavily on FSD. Goldstein left Boston University in May 2005, and at the time of writing is ‘currently in the process of seeking a new location for his sexual medicine practice’.1 He is still the editor of the Journal of Sexual Medicine, and this position has afforded him continued power to shape discussion on FSD. For example, an article in the July 2004 issue, which he edited, included new FSD guidelines based on work at a critical 2003 FSD conference in Paris. Even though a ‘progress report’ at that conference had noted the lack of scientific data supporting the utility of drug-treatment regimens for FSD, the article explicitly endorsed investigational use of Viagra-type and testos- terone products for this purpose (O’Connor, 2005).

Strategy I: Securing FDA approval for a woman’s sex drug Pfizer determined that clinical trials of Viagra in women showed that it is no more effective than a placebo, and the company stopped the trials in February 2004 (Harris, 2004). While some drug companies are still developing products that follow a ‘Viagra model’ by targeting genital blood flow (e.g. alprostadil), and others are developing products like PT-141 that aim to augment dopamine-like brain chemicals (Enserik, 2005), arguably the main focus in drug development now is on products specifically intended to enhance sexual desire, mainly through the administration of testosterone. At least seven drug companies are develop- ing testosterone products for women (NAMS, 2005).

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When Viagra was being tested in women, the targeted condition was ‘female sexual arousal disorder’ (FSAD). When these trials came up empty, not only did the focus in drug development shift to testosterone but also the intended targeted condition changed to ‘hypoactive sexual desire disorder’ (HSDD). Just months after Pfizer pulled the plug on the Viagra trials because the drug did not enhance arousal, Proctor and Gamble (P&G) announced plans to seek FDA approval later that year for its Intrinsa testosterone patch to treat desire problems. This shift from FSD ‘being about’ an arousal problem to FSD ‘being about’ a desire problem seems to have gone largely unnoticed by most cultural commentators. Yet the shift in focus from FSAD to HSDD is a dramatic illustration of active drug industry ‘disease mongering’ tactics (Payer, 1992; Tiefer, 2006) – the change seems to indicate an effort to match up some drug (any drug?) with some subcomponent (any subcomponent?) of the DSM classification. Did women’s problems with arousal suddenly go away? Of course not, but mainstream media, following the P&G marketing spin, proclaimed the failure of the Viagra trials to be evidence of women’s ‘more complex’ sexuality, and they moved on to the ‘next big thing’.

The ‘hormone of desire’ And the ‘next big thing’ was the focus on testosterone as the ‘hormone of desire’. A dominant medical explanation for ‘hypoactive sexual desire disorder’ (HSDD) is that it is a product of ‘androgen insufficiency syndrome’ (Fishman, 2004). This linkage has fueled development and promotion of androgen replacement therapies for women’s sexual problems – primarily prescription-only testosterone and over-the-counter dehydroepiandrosterone (DHEA) treatments (see Hartley, 2003). In spite of the known risks of such therapies (Basson et al., 2001; Fourcroy, 2001), the paucity of data on the efficacy of such treatments, and even promi- nent articles that demonstrate no linkage between low sexual desire and low testosterone levels (Davis et al., 2005), drug development efforts increasingly concentrate in this area and growing numbers of physicians are prescribing testosterone off-label to women.

With hopes of being the first to win FDA approval (key to dominating the market), P&G sought approval for its Intrinsa testosterone patch in December 2004. The FDA advisory committee determined that the benefit of the drug (an average of one additional sex act per month) was overshadowed by the patch’s potential health risks. The recent drug safety scandals surrounding Vioxx and hormone replacement therapy (HRT) likely influenced the FDA advisors to be more risk-adverse than in the past, and they unanimously voted against approval of Intrinsa. Critics were also particularly concerned that were Intrinsa approved for its target population – surgically menopausal women also taking estrogen – that

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marketing surrounding the drug would also target and drive up off-label prescriptions for women outside that main group.2 Ironically, P&G tried to use the existence of off-label prescribing of testosterone to its advan- tage. Especially for prescription testosterone products, determining off- label dosage for women is a guessing game, and P&G has argued that its patch would insure more consistent and accurate dosage (Neff, 2003).

Strategy II (the new game): Off-label prescribing of men’s sex drugs to women The two erectile dysfunction drugs approved in the US after Viagra, Levitra and Cialis, represent only the tip of the iceberg, as a wide variety of other products are in development for men, including drugs for premature ejaculation and PT-141, a nasal spray intended to act as an aphrodisiac. Additionally, testosterone replacement products such as AndroGel and Testim are increasingly promoted as treatments for men’s sexual problems. While none of these drugs approved for use in men – Viagra, Levitra, Cialis, AndroGel, and Testim – has been sufficiently tested or proven for use in women, increasingly, when women discuss their sexual problems with their doctors, they are given ‘off-label’ prescriptions for one or another of these products. Testosterone researcher Dr Jan Shifren estimates that one-fifth of all the prescriptions of testosterone products approved for men are actually written (off-label) for women (Kantrowitz and Wingert, 2005).

The Federal Drug Administration Modernization Act (FDAMA) of 1997 loosened the restrictions on the type of information that drug companies could share with physicians regarding off-label uses for their drugs (Conrad and Leiter, 2004), thus facilitating a general growth in off-label prescrib- ing. Although drug companies are not allowed officially to market drugs for off-label uses, the companies are largely able to circumvent this law by ‘merely informing’ doctors of these uses at ‘educational’ CME conferences (Angell, 2004). A key reason why numbers of physicians are writing these off-label prescriptions for women is their exposure to presentations at CME conferences on FSD (such as those hosted by ISSWSH) that have promoted a biomedical perspective on sexual problems, conceptualized women’s sexual problems as largely based in ‘androgen deficiencies,’ and reported ‘anecdotal’ stories of success in treating female patients with testosterone (Fishman, 2004; Hartley, 2003; Hartley and Tiefer, 2003; Loe, 2004). Such off-label prescribing is also becoming increasingly normalized in mainstream media accounts of FSD. For example, the 3 May 2004 CBS Evening News ran a segment showing two women being treated with testos- terone for their libido problems (CBSNEWS, 2004).

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Five years ago, it seemed that such off-label prescribing practices repre- sented a ‘side game’ in the larger effort to pharmacologically manage women’s sexual problems – a way to prescribe a little something to women until they got their own FDA-approved ‘Pink Viagra’. Today, however, it is becoming increasingly clear that off-label prescribing represents some- thing much larger: a way to circumvent the FDA-approval process altogether in some cases. Why bother to conduct expensive clinical trials and risk having a drug denied approval in the end? The story of the media celebrity Berman sisters dramatically illustrates the importance of off-label prescribing, as an even cursory look at their advice and treatment prac- tices reveals an infrastructure largely built on off-label prescriptions.

Working the lay audience The Bermans: Leaving evidence-based practice for the big money No successful campaign of medicalization would be complete without active advocates dedicated to the shaping of consumer opinion. On this count, two ‘sexperts’ have risen to particular prominence in mainstream media coverage of FSD: Laura Berman, PhD (a sex therapist) and Jennifer Berman, MD (a urologist). This sister team was originally trained at the Boston University Urology Department by Irwin Goldstein. They left Boston University in 2001 to co-direct the UCLA Female Sexual Medicine Center (FSMC) in Los Angeles. In 2004, Laura Berman left UCLA and used venture capital to open the Berman Center, a treatment clinic in Chicago. In 2005, Jennifer Berman also left UCLA to relocate in the private sector, opening a sexual medicine practice at the Rodeo Drive Women’s Health Center in Beverly Hills (O’Connor, 2005). The shift of the Bermans’ practices from academic centers to the explicitly for- profit commercial sector speaks volumes about the new ‘Viagra culture’. It is important to point out that the Berman sisters’ crossover appeal to mainstream and academic audiences has garnered them significant power to shape discussion about FSD. Women in search of solutions to their sexual problems often turn to mass media resources such as popular maga- zines or television talk shows, where the Berman sisters have high levels of visibility. The sisters have been featured in numerous popular publi- cations (such as Cosmopolitan, Discover, Marie Claire, Fitness, Redbook, Magazine, Ladies Home Journal, Vogue, and others); have appeared on many TV shows (such as Good Morning America, The Oprah Winfrey Show and 20/20); have an ‘official web site’ (http://www.newshe.com/); hosted 65 episodes of their weekly cable television talk show on the Discovery Health Channel (called Berman & Berman) over the course of three years (O’Connor, 2005) and, with co-writers, published two books on women’s sexual problems aimed at a popular audience (Berman and

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Berman, 2001, 2005). Their popularity and visibility have been enhanced through their efforts to cultivate a sense of intimacy with their viewing public, as evidenced, for example, by the link on their web site to a ‘medically explicit’ video of Jennifer’s elective cesarean birth, complete with her personal descriptions of her recovery process.3

In short, the Berman sisters are adept at using media to promote their own industry. The commercial infrastructure of Laura’s Berman Center is more developed than is Jennifer’s Rodeo Drive Clinic, which just had its launch party (modeled after BCBG clothing store’s launch ‘concept’ – see O’Connor, 2005) in late 2005. The slick web site for the Berman Center4 does not try to obscure the connections between business, the practice, and use of mass media, proclaiming: ‘Berman Health and Media is a multi- media company specializing in women’s health across two complementary business domains: the Berman Center clinic based in Chicago, Illinois and Dr. Laura Berman’s multi-media platform.’ The Center’s web site boasts of Laura’s position as a ‘thought-leader in the field of women’s health’ and her ‘400 million media impressions each year’ and provides a down- loadable press kit, complete with several high-resolution photos of Laura available for media use. The commercial nature of the practice is further reinforced by description of the facility’s ‘tranquil, spa-like environment’ with ‘soothing colors, clean and simple design and specialized window shades’ that ‘make it an ideal facility for on-camera appearances’. The specialized window shades may come in handy as the cameras are filming Showtime’s new reality TV series, called Sexual Healing and scheduled to be broadcast in 2006, at the Berman Center. The site goes on to describe a recent merger and equity financing project that, through ‘private place- ment of its common stock’, will enable the Center to increase its number of ‘upscale spa-like’ clinics; expand its CME courses; increase Laura’s visi- bility in print, television and radio outlets; and facilitate ‘lifestyle endorse- ment and branding opportunities with leading pharmaceutical and consumer products companies’ (Berman Center, 2004).

Jennifer’s Rodeo Drive practice promises to follow the same model: a ‘boutique practice, outside of academia’, intending to deliver ‘quality care in a spa-like high-end environment’ (O’Connor, 2005). So what might the sisters mean by ‘high end’? A review of the ‘make an appointment’ section of the Berman Center’s web site,5 where a prospective client can secure an appointment with a credit card number, indicates that an initial assessment will cost $550 plus testing. Another $550 buys a session of ‘bio-identical hormone therapy’. There’s no mention of insurance. Even their former mentor, Dr Goldstein, has publicly commented on the commercialized direction of this sort of practice: ‘[Jennifer] didn’t want to be in our world. I presume her world may be more lucrative’. If looking at nothing else, considering that the sisters’ appearances on TV and other

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venues come with a price tag of ‘$10,000 to $75,000 or more per day’ (O’Connor, 2005), Dr Goldstein appears correct in his diagnosis.

Even more important than their sheer visibility in media outlets and the commercialized nature of their practices, however, is the content of their message and their approach to treatment. Although the Bermans regu- larly assert that their approach to women’s sexual problems combines the strengths of psychotherapy with the benefits of the new sexual medicine, they ultimately give preference to the biomedical perspective. For example, in a chapter from For Women Only (Berman and Berman, 2001) that describes the combined role of medicine and therapy, they dedicate 25 pages to medical approaches and only four pages to therapy (see Hartley, 2002 for a review/critique of that book). Their disproportionate focus on the medical approach was also highlighted in a 20/20 television special on women’s sexuality in February 2004.6 One segment of the program showed a woman in to see the Bermans about her low levels of sexual desire after her husband had essentially threatened to leave her if the issue was not resolved. After conducting a battery of physiological tests, the Bermans failed to find any physical ‘indicators’ of her depressed libido (e.g. no sign of ‘low’ testosterone), yet they gave her a prescription for AndroGel anyway, and the problematic nature of her relationship with her husband went essentially unaddressed.

The continued insistence on prescribing Viagra and other ‘male’ sex drugs off-label for women illustrates the departure from a science-based practice and the embrace of a retail Viagra culture. In response to Pfizer’s decision to stop testing Viagra in women, Laura Berman and a colleague published a short piece on the NEWSHE web site declaring, ‘Viagra is a safe and useful drug . . . and for those whom it helps, I will continue to write scripts for it’ (Murdock and Berman, 2004). Both of the Bermans’ books, including the one that came out after the 2004 cessation of the Viagra trials in women, promote off-label use of Viagra and testosterone in women.

The sisters’ academic work also privileges commercial connections. While in Boston, Jennifer consulted with numbers of drug companies, including Pfizer, Bayer, Proctor and Gamble, Eli Lilly – in her words, ‘all of them’ (O’Connor, 2005). Together the sisters co-chaired several annual Women’s Sexual Health State-of-the-Art conferences at UCLA. These CME conferences are now based out of Chicago, where Laura maintains an academic appointment at the Feinberg School of Medicine at Northwestern University, and they are now offered more frequently; the course is scheduled to run at least three times in 2006 – in California, New York and Illinois.7 From its inception, the conference has empha- sized ‘cutting edge information on the evaluation, diagnosis, and treat- ment of female sexual function complaints’ (Network for Excellence in

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Women’s Sexual Health, 2004). The ‘cutting edge information’ tends to be medical, as shown in their 2004 program, where all but one of the talks on sexuality covered medical dimensions such as genes, hormones, and neurobiology. Perhaps not surprisingly, that conference was sponsored by an ‘unrestricted educational grant’ from the pharmaceutical company Organon, a major purveyor of testosterone supplements and a promoter of a hormone replacement therapy for FSD called Livial (Organon Inter- national, 2004).

A strategy for legitimacy: A nutraceutical poses as a pharmaceutical While direct-to-consumer (DTC) advertising will become increasingly important in mass media outlets once the FDA approves an FSD drug (see Gillis, 2001), currently, the only FSD products that are widely advertised are those from the over-the-counter herbal/botanical/dietary supplement market that do not fall within the FDA’s jurisdiction. Two such products that have gained particular visibility are Avlimil and Zestra. What is particularly interesting about the marketing platforms for both products is the attempt to make the products seem ‘like prescription drugs’.

Avlimil is a product that contains a ‘proprietary blend’ of eleven herbs, including sage leaf, red raspberry leaf, kudzu root extract, capsicum pepper, licorice root and others.8 The initial US advertising campaign for Avlimil followed the same pattern as that of other like products – assur- ances that this once a day tablet will enable women to attain a ‘fuller, more satisfying sex life’ and promises of equality: ‘They have Viagra. Now we have Avlimil’.9 But what set the campaign for Avlimil apart from the pack was the attempt to mimic a prescription drug advertisement. The two- page advertisements included a side bar full of small print, instructions to ‘ask your health care provider’ about the product, and references to the JAMA 31 per cent/43 per cent article. Even the packaging, a lavender oval punch-out container resembling that for birth control pills, further reinforced prescription drug connotations.

The effort to create a market for Avlimil by mimicking a prescription drug advertisement is testimony to the marketers’ perceptions of growing public support for pharmacological management of women’s sexual problems. Their approach appears to be successful, as consumers placed about 500,000 orders for Avlimil in the first year of its release (CBSNEWS, 2003). Those central to the promotion of prescription drugs for FSD are not necessarily happy with the Avlimil advertisements, however. Their prescription-drug appearance prompted Irwin Goldstein to alert the Federal Trade Commission (FTC), which has jurisdiction over these adver- tisements (Reid, 2003). Additionally, the ISSWSH online discussion group addressed Avlimil in March 2004, with many of the discussion participants critiquing Avlimil from the perspective that it is a dietary supplement and

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not well studied. Such positions are especially ironic when coming from those who advocate use of the not well studied dietary supplement DHEA for low sexual desire.

The marketing strategy for Zestra, described as a combination of ‘pure botanical oils’ (Zestra, 2006), is also interesting in its mimicry of well-worn prescription drug pathways. The product, sold over-the-counter at Walgreens and similar drug stores, is advertised as having been tested like a prescription drug. The promoters boast that Zestra has been tested ‘in conformance with FDA standards’ by ‘independent medical researchers’ in studies ‘published in peer-reviewed medical journals’ (Zestra, 2006). The Zestra web site has links to conferences where the studies have been presented (there have been several presentations at the ISSWSH meetings).

Controversy and critique: Public health advocacy and challenges to medicalization The medicalization of women’s sexual problems is being met with growing resistance and critique. For example, in January 2003, Australian journalist and pharmaceutical-industry gadfly Ray Moynihan published an article in the British Medical Journal (BMJ) that generated an impressive number of responses from both critics and supporters of the pharma- ceutical industry’s development of an FSD drug. The take-home message of the piece, entitled ‘The Making of a Disease: Female Sexual Dysfunc- tion’, is that FSD is a prime example of ‘the corporate-sponsored creation of a disease’ (Moynihan, 2003a: 45). As core evidence, Moynihan presents data on the significant levels of industry sponsorship of key FSD confer- ences (including those three Boston-based meetings), arguing that the companies funded the meetings to create a ‘clearly defined medical diag- nosis with measurable characteristics to facilitate credible clinical trials’ (Moynihan, 2003a: 45. See Hartley, 2003 and Hartley and Tiefer, 2003 for similar observations). As evidence of the fear the article generated in the drug industry, an unnamed pharmaceutical company – Pfizer, Bayer and Lilly-ICOS are the likely candidates – even hired a public relations company to launch a global campaign to counter the charges made in the piece (Moynihan, 2003b).

Critical viewpoints on FSD have also been appearing in a growing number of mainstream publications. For example, in 2005, the Seattle Times ran several stories exploring the process of disease-mongering for its series entitled ‘Suddenly Sick’, featuring FSD as one of its prime examples (Kelleher, 2005). As another example, the Los Angeles Times published a critical piece later that year on Jennifer Berman’s new Rodeo Drive practice (O’Connor, 2005). And as discussed elsewhere in this issue

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by Leonore Tiefer, an activist/advocacy group called the New View Campaign has used a variety of tactics to challenge the disease-mongering of FSD for over five years.10 Since its 2000 inception, the New View has emphasized the prevention of women’s sexual problems and has called for resituating women’s sexuality within the political domain (away from the health-and-treatment domain). Several New View members testified against Intrinsa approval at the FDA hearing, and the group assembled and made available a range of educational materials for that hearing (FSD-Alert.org, 2004–2006). Other central events of the New View Campaign have included: the formulation of a classification system to compete with that in the DSM (see Kaschak and Tiefer, 2001); a 2000 press conference; publication of a book (Kaschak and Tiefer, 2001); the creation of a web site; the creation of a teaching manual; the creation and maintenance of a listserve; the creation of a CME course, released on Medscape; and the organization of two professional conferences on the topic.11 The campaign has been covered in major US newspapers, including the Washington Post, the Chicago Tribune, the Boston Globe, the Los Angeles Times, and the Wall Street Journal; in newsmagazines, including Time and Newsweek; and in television news programs on all three main networks.

The increasing promotion and prescription of lifestyle drugs, coupled with the aging of the baby boom population, suggests that the medical- ization of sexual function is likely to expand. Even though Intrinsa was denied FDA approval, the media are monitoring the development of a growing avalanche of FSD drugs, many currently in the later stages of the clinical trial process. And pharmaceutical companies are backing up this product development with serious PR and marketing campaigns – for example, it was estimated that P&G would provide a marketing launch budget of as much as $100 million for Intrinsa were it approved (Neff, 2003).

Resistance to this expansion, however, is also growing rapidly. Recent drug scandals, such as those involving the Vioxx brand pain reliever and hormone replacement therapy (HRT), have inflamed public concerns about potentially unsafe drugs being approved for market. The critiques – both academic and popular – of the drug industry are increasing (see, e.g., Abramson, 2004; Angell, 2004; Kassirer, 2005). Moreover, these drug industry critiques can be read as just one example of a broad public health advocacy movement intent on challenging harmful corporate prac- tices (Freudenberg, 2005); earlier in this issue, Tiefer called the work of the New View campaign ‘part of a new public health advocacy movement dealing with corporate practices that affect health, such as those in the tobacco, automobile, and food industries’. It seems that this tension – between growing biocorporate power (medicalization being one process

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facilitating that growth) and resistance to that power – will become more pronounced in the coming years.

Notes 1. As reported on his web site, URL (accessed 24 January 2006)

www.irwingoldsteinmd.com 2. See FSD-Alert.org (2004–2006) for a variety of critical positions on

Intrinsa. 3. See http://www.newshe.com/episodevideos.shtml (accessed 25 January

2006). 4. See http://www.bermancenter.com (all direct quotations following in the

text were accessed 25 January 2006). 5. The ‘make an appointment’ link takes you to https://mmm1115.

verio-web.com/rikker/bermancenter/so/index.php (accessed March 2006).

6. Irwin Goldstein has also played a role in promoting a medicalized notion of women’s sexuality to a lay audience. For example, he was the doctor prescribing testosterone in the May 2004 edition of the CBS evening news discussed earlier in the article.

7. See http://www.bermancenter.com/cme/index.html (accessed 25 January 2006).

8. See http://www.avlimil.com/avlimilblend.html (accessed 25 January 2006). 9. Quoted from advertisement appearing in Working Mother magazine, March

2003, pp. 76–7. 10. See FSD-Alert.org (2004–2006) for full documentation of the campaign. 11. The group’s first conference, held in San Francisco in March 2002, drew

close to 140 participants. The second conference, held in Montreal, Quebec in July 2005, drew about 200 attendees.

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Biographical Note Heather Hartley, PhD is an Associate Professor of Sociology at Portland State University in Portland, Oregon. She teaches courses on gender, sexuality and health. Her research examines the drug industry as an increasingly important ‘engine of medicalization’. Recent projects have focused on the medicalization of sexual problems and the impact of direct-to-consumer (DTC) advertising in the United States. Address: Department of Sociology, Portland State University, PO Box 751, Portland, OR 97207, USA. [email: [email protected]]

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