Sexology and the Pharmaceutical Industry: The Threat of Co-optation

Journal of Sex Research,  August, 2000  by Leonore Tiefer

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Because the public (and the media) must try to evaluate potential improprieties, major medical and scientific journals now require disclosure of all funding sources (and other legal/financial arrangements) as part of manuscript review, and require that such information appear when studies are published. A recent sex research study neglected to mention the pharmaceutical company connections of the authors, an omission quickly pointed out by The New York Times (Grady, 1999; Laumann et al., 1999). Concerns about scientific integrity are increasing, as "the pharmaceutical industry and clinical research are so completely intertwined that it is frequently difficult to find experts who are not in some way tied to the industry" (Valenstein, 1998, p. 199).(4)

How can we assess how sex research is affected by pharmaceutical industry sponsorship? The usual method is to compare results of studies funded versus unfunded by industry, a method which has repeatedly found that company-sponsored studies have more outcomes which favor the drugs (Altman, 1997). To take a recent example, a comparison of the results of 91 behavioral studies with and without tobacco industry support showed that industry-supported papers typically showed that nicotine or smoking improved cognitive performance, while non-industry-supported research studies were more nearly split in their conclusions (Turner & Spillich, 1997). Unfortunately, and ironically, too few studies in sex research journals cite any funding to do this kind of comparison at the present.

It will be important to document how inclusive pharmaceutical industry-sponsored research is in its subjects and methods. The clinical trials prior to Viagra's approval excluded gay men, for example, despite the fact that using nitrates for recreational purposes is common in the gay community; and the combination of Viagra and nitrates can be fatal (Kirby, 1998). Moreover, many individuals who are likely to use Viagra were disqualified from the clinical trials because of pre-existing physical conditions (e.g., poorly controlled diabetes, history of alcohol abuse, stroke or heart attack within past six months) (Goldstein et al., 1998). Pfizer representatives said that men taking heart medications were excluded because "we thought they wouldn't be thinking about sex" and their numerous medications might make it difficult to ascertain the effectiveness of Viagra (Brownlee & Schultz, 1999, p. 63). Were these patients excluded because they would have shown less benefit from the drug? Were gay patients excluded because they would give a "sex drug" the wrong public image?

Recognizing that companies are tempted to "introduce new products without exhaustively investigating their potential risks," the FDA has continuously improved its oversight of study design, but the case of sexuality-enhancing drugs provides unprecedented moral and public image challenges (Merrill, 1997, p. 94). Goldstein et al. (1998) reported that only men in stable heterosexual relationships of at least six months' duration were enrolled in the Viagra trials, yet "only 25 percent of the partners completed the optional questionnaire" (p. 1402). No data from even those partners were included in the final drug trials publication. During an informal conversation two months after Viagra's approval, one of the study's main authors acknowledged that women gave lower estimates of the drug's effect on erection than did men, an effect which has recently been replicated with statistical significance (Cohen, 1998; Salonia et al., 1999). There is no requirement that all collected data be published, and companies may withhold data which undercut their claims.