From Unease to Disease: Redefining Male and Female Sexual Function in the Quest for a Broader Market

Sex sells, and nowhere is this more obvious than in the market for pharmaceuticals aimed at enhancing sexual performance. Campaigns designed to turn healthy people into patients were the topic of an International Conference on Disease-Mongering held in Australia April 11-13, 2006. In anticipation of the conference, a recent issue of PLoS Medicine issued by the Public Library of Science (PLoS) was devoted to the same topic, defined as "the selling of sickness that widens the boundaries of illness and grows the markets for those who sell and deliver treatment" (See article by Moynihan and Healy in this issue). PLoS is a non-profit organization of scientists and physicians committed to making the world’s scientific and medical literature a freely available public resource. The journal examined two case studies of the interaction between anxiety over sexual performance and the marketing of pharmaceutical products.

The first of these is titled "Bigger and Better: How Pfizer Redefined Erectile Dysfunction," by Joel Lexchin, who is affiliated with York University and with the University of Toronto. The article examines how Pfizer transformed Viagra from a product to treat erectile dysfunction (ED) due to medical problems such as diabetes and spinal cord damage into a drug that ‘ normal’ men can use to achieve and maintain an erection for a longer period of time.

If Viagra had been confined to men with ED related to organic causes, writes Lexchin, the drug would probably have been a modest success for Pfizer. But expanding the market required appealing to a wider population of men, and that meant redefining the criterion for those who could benefit from the available treatment. Thus, Viagra had to be seen as an option for men with any degree of ED, including sporadic failures to achieve and maintain erections. Using questionable data and trumpeting success rates of "more than 80%," Pfizer’s marketing materials and advertising campaign aimed at a younger cohort of men, and included the message of relief for occasional erection problems. The results were not insignificant: between 1998 and 2002, men between the ages of 18 and 45 showed the largest increase in Viagra use, although only one-third had a possible etiologic reason for needing the drug. Part of this trend may be attributed to an increase in gay and bisexual men using Viagra to enhance their sexual performance. As a result, studies on men who have sex with men reveal that the drug has been associated with potentially dangerous interactions with HIV medication, as well as with a rise in high-risk sexual behavior, including intercourse with a greater number of sex partners, higher levels of unprotected anal sex with HIV+ partners, and a higher incidence of STDs.

The Viagra story, Lexchin writes, presents "a microcosm of the debate surrounding drugs that enhance lifestyle choices. The drug is effective… for people with medical problems…, but it can also be used by a much wider population." Targeting the larger community and narrowing treatment options to the single option of medication assures the health of the manufacturing company. But this may also inflict an array of potential dangers on the broader population, and raise questions about how finite resources are spent and decisions on treatment are made.

No sooner had Viagra been launched that the media began calling for a "female Viagra." In a second case study published in PLoS Medicine, Leonore Tiefer, a clinical associate professor of psychiatry at New York University School of Medicine, describes the creation of "female sexual dysfunction (FSD)," a disease entity plagued by definitional issues and a history of unsuccessful pharmaceutical interventions. FSD was defined as disorders of libido, arousal, orgasm, and pain leading to personal distress and interpersonal difficulties, a definition broad enough to encompass 43% of a sample of women between the ages of 18 and 59 who were surveyed in 1999.

Eager to capitalize on its success with men, Pfizer promoted FSD and sought to have Viagra approved to treat "female sexual arousal disorder." But its efforts ended in 2004 following consistently poor clinical-trial results. Procter & Gamble, however, was ready to join the quest for a potential drug for FSD. The company developed a transdermal testosterone patch (Intrinsa) to treat "hypoactive sexual desire disorder." As Tiefer points out, the shift from arousal to low libido suggests that "the effort to match up some drug with FSD moved freely among symptoms and labels." Despite its versatility, Procter & Gamble was no more successful that Pfizer, and an FDA advisory panel voted unanimously not to approve Intrinsa, saying that P&G had not provided sufficient long-term safety data and questioning the clinical significance of the Intrinsa trials.

The patch failed to meet the FDA’s main criterion, that it would show "clinically significant changes in the number of successful and satisfying sexual events experienced by a woman." Indeed, the risk-benefit calculus posed by the patch was clearly unacceptable. As Dr. Sidney Wolfe, testifying on behalf of Public Citizen’s Health Research Group, stated in December 2004 at the FDA Advisory Committee meeting, the key question was the following: "Is an increase in approximately one sexually satisfying encounter a month (not from zero to one, but from approximately four to five times per month) worth the possibility of an increase in breast cancer or coronary artery disease?"

In addition to the opposition from researchers and patient advocates, FDS also met with the activist opposition of a group of women who questioned the wisdom of transposing to women the mechanistic, physiology-driven view of sexuality that had been applied to men. Led by Leonore Tiefer, the "Campaign for a New View of Women’s Sexual Problems" presented a theoretical critique of the medical model of sexual problems, and adopted an activist stance that viewed with skepticism any emerging FSD drug. The critique seeks to debunk the prevailing sexual dysfunction classification; the activism, to challenge recurring biases in clinical trials, the dangers of off-label promotion, researchers’ conflicts of interest, and neglect of nonmedical theory and research on sexuality.

While ED was a marketing success, at least for a time, FSD has proved to a more elusive target, thanks in part to the watchdog activities of Tiefer, her associates, and other allies. Still, Tiefer points out that the pharmaceutical industry’s aggressive interest in sex has led to the use of "public relations, direct-to-consumer advertising, promotion of off-label prescribing, and other tactics to create a sense of widespread sexual inadequacy and interest in drug treatments." And Susan Kelleher, a reporter from the Seattle Times, states that "today, FSD has all the trappings of a well-established disease: spokespeople, alarming statistics, a political lobby, a medical specialty and an academic journal." With such ammunition on their side, the pharmaceutical industry can be counted on to mount a fierce battle. In the words of Ray Moynihan, guest editor of the PloS Medicine issue on disease-mongering, "we might all have to start relying a little less on marketing and promotion of new diseases, dressed up as science and education."