Sexology and the Pharmaceutical Industry: The Threat of Co-optation.
by Leonore Tiefer
It's 1998. Turn on the television and you're sure to see a newsmagazine program about a new prescription medication named Viagra and its wonderful benefits for men's sexuality. Open a newspaper and you're sure to see a story about the promising effects of Viagra on women. Open the Journal of Sex and Marital Therapy and find an editorial announcing a "Pharmacological era in the treatment of sexual disorders" (Segraves, 1998).
It's 1999. Open the Journal of the American Medical Association (JAMA) to find an article reanalyzing old data to emphasize the high prevalence of sexual dysfunction in the United States (Laumann, Paik, & Rosen, 1999). Read The New York Times a few days later to find the JAMA article's sexologist authors identified as paid consultants to Pfizer, the manufacturer of Viagra (Grady, 1999). Receive your copy of the Journal of Sex and Marital Therapy and find the back cover has become a glossy multicolor ad for buy Viagra online .
The search for aphrodisiacs to stimulate sexuality and potions to resist sexual decline is age-old, but it entered a new chapter at the end of the twentieth century with official federal Food and Drug Administration approval of sex-enhancing drugs. Sex researchers are playing a growing role in the development and distribution of the new sex drugs. Is sexology on its way to becoming a subsidiary of the pharmaceutical industry? I hope not, but the recent history of psychiatry shows how an entire field can be taken over by pro-pharmaceutical thinking and practice, and this example should make us very worried (Healy, 1998).
Is sexology in danger of being co-opted by the pharmaceutical industry? Co-optation is defined as appropriation or takeover of a previously independent group by a larger power in a kind of a bloodless conquest. For the smaller group the takeover offers certain benefits (e.g., increased recognition or protection) at the cost of intellectual or political independence. In this paper, I will argue that the creeping co-optation of sexology by the pharmaceutical industry represents a Faustian bargain, whereby in exchange for some new research and professional opportunities, sexology is in serious danger of selling out a unique and socially important sexual vision and role. Note that this paper is not about the co-optation of sex by the pharmaceutical industry. That's a somewhat different story. This story is about a possible takeover of sexology, a particular professional and academic family, by the pharmaceutical industry. You might say it's an essay on family values.
The paper begins with a wide-angle look at the background of this co-optation threat, which I see as the latest stage in the medicalization of sexuality, a subject I have been chronicling for over a decade (Tiefer, 1986, 1994, 1995, 1996). Once we see how interest in this collaboration arises from a broad array of socioeconomic and political forces affecting both the pharmaceutical industry and sexology, we will be better able to identify its attractions and its dangers.
Coincidentally, or maybe not, a brand new academic multidiscipline, sexuality studies, has developed within the humanities, social sciences, and cultural studies at just the present moment. Organizations, journals, conferences, and the other elements of academic infrastructure are emerging, and participants in the new sexuality studies have proclaimed it to be resolutely antimedical in its approach to understanding sexuality (Gagnon & Parker, 1995).(1) If the new, intense pharmaceutical industry role heralds the sinking of independent biomedical sex research, it appears that an academic lifeboat may be at the ready for at least some scholars.
WHY IS THE PHARMACEUTICAL INDUSTRY INTERESTED IN SEX?
This section will introduce themes in the larger social and economic culture which sex researchers typically ignore. It's important to notice that the pharmaceutical industry has only recently become interested in sex, and to discuss the reasons why: a favorable political environment, deregulation of the pharmaceutical industry, and favorable commercial opportunities.
Favorable Political Environment
Since 1980, enormous political and economic changes have occurred in both academia and business to bring the two closer together (Kennedy, 1997; Marsa, 1997; Slaughter & Leslie, 1997; Teitelman, 1994). A new ideological climate (politically known as Thatcher-Reagan economic conservatism) came to prevail, which venerated competition and entrepreneurship in both public and private institutions. It resulted in important changes in tax and patent laws, laws governing nonprofit corporations, and federal funding of research and training. As public institutions and services from prisons to garbage collection have become privatized in the last two decades, universities and scientific communities have followed suit.
Sheila Slaughter, a sociologist of science, described a recent shift in science ideology from the "cornucopia" model of science to the "partnership in innovation" model of science (Slaughter, 1993, p. 284, p. 289). She recounts that, prior to the 1980s, academic biology was largely a basic science whose faculty were concerned with government-sponsored science and training grants. By the mid-1980s, however, most full professors of molecular biology served on the advisory boards of biotechnology corporations and owned stock in spinoff companies selling products based on the professors' academic research.
In Slaughter's cornucopia model, scientists pursued theoretical and empirical issues in an unfettered atmosphere, beholden only to the norms of science. Strong government funding encouraged knowledge accumulation that eventually would pay off in terms of theory, or application to health, defense, or industry. Klass (1975) called this the "gee whiz" model of science, although its total purity may have been largely mythical (e.g., Barnes, Bloor, & Henry, 1996). The cornucopia model held its own in academic science until the Reagan-Thatcher revolution introduced new sets of national priorities, identified commercial innovation as the key to prosperity, and earmarked science as the new partner of business (Slaughter, 1993; Slaughter & Leslie, 1997). Basic research became only the first step of a process which now included developing the original ideas and discoveries for the market. Adding application to the expectations of scientific work wasn't totally unknown, but making it a legitimate and expected part of academic science was new.
It is especially important to recognize that the overall ideological shift dictated that the new academic relationship with industry occurred alongside declining government support for research, students, and academic programs, and therefore that commercial funding for science became a university necessity in the 1980s (Kennedy, 1997). Repeated Congressional hearings during the 1980s, as the Democratic-controlled Congress struggled to resist the Reagan revolution, examined new conflicts of interest which arose as faculty energy was diverted into commercial pursuits. But those public examinations ended with the loss of the Democratic majority in both the Senate and the House in 1994.
Deregulation of the Pharmaceutical Industry
The second background element to consider is pharmaceutical industry change. Payer (1992) argues that the pharmaceutical industry has become the most profitable industry in the United States (also see Pryor, 1997). Because there is so incredibly much money to be made, the industry is huge and hugely competitive, with thousands of intensely competitive employees working on new products, looking for new markets, and creating new ways to link the two. Challenges from managed care have been compensated for by increased marketing and speeded-up Food and Drug Administration (FDA) approval processes for new drugs (Ballance, 1996; Eichenwald & Kolata, 1999). Most importantly, a cooperative Congress modified FDA regulations to allow television and print advertising directly to the public as of August, 1997 (Morrow, 1998), a change which pharmaceutical industry analysts predicted would multiply sales and increase companies' reliance on "blockbuster" drugs (Langreth, 1998). Currently, about one fifth of the revenue of leading companies results from sales of these "blockbuster" drugs (Ballance, 1996). Drug ads to the public so far "are just the initial forays in what marketing experts believe will be a steady march toward the kind of aggressive, image-filled, and patently manipulative advertising that so successfully sells Americans everything from cars to cosmetics" (Morrow, 1998, p. 1). The internet has furthered the marketing of drugs into the home (Stolberg, 1999b).
The initial print ads for Viagra, popping up in publications from Time to The American Psychologist to the Playbill theater magazine given to every New York City playgoer, seem to be living up to this promise. They feature nothing but a large color image of a smiling couple in a dancing embrace and, in small print, the words "Viagra," "sildenafil citrate tablets" and either "let the dance begin" or "take the first step." Moreover, whereas drug ads have long been a staple in medical journals, for the first time a sex research journal features the same dancing couple Viagra ad on the 1999 back covers of The Journal of Sex and Marital Therapy. The Code of Federal Regulations, detailing the FDA's rules for prescription drug advertising, describes a category of exceptions to the usual drug ad rules called reminder advertisements which are allowed to "call attention to the name of the drug product but do not include indications or dosage recommendations" (Code of Federal Regulations [CFR], 1998, p. 60). Thus, the dancing Viagra couple, sans any prescribing information, warnings, or indications, may become as ubiquitous as those globally recognizable golden arches.
Changes in FDA regulation are also relevant to the atmosphere and conduct of sexuopharmacology research (Healy, 1998; Liebenau, 1987). Regulations affecting drug approval, licensure, and advertisement invariably slow drug production and sale, and the industry has complained about such limitations since the earliest regulatory acts of 1902 and 1906 first forbade unsubstantiated claims on medical labels. United States drug regulation has followed a pattern of expansion following a health disaster (e.g., thalidomide in 1962) and retraction once the immediate shock of the disaster is over (Merrill, 1997).
However, despite the simplified ad images permitted by the reminder classification, drugs are powerful agents with serious physical consequences. A 1985 General Accounting Office report showed that nearly half the new drugs approved between 1976 and 1985 had fatal side effects not identified during testing (Arno & Feiden, 1992), and the FDA is coming to recognize that the rise in drug sales, combined with the aging of the population, is resulting in an increase in fatalities due to error and unanticipated effects of mixing drugs (Stolberg, 1999a). It should come as no surprise to find a cover story on Viagra in U.S. News and World Report less than 10 months after the drug was approved reporting widespread side effects, with the sensational title, "Dying for sex: The FDA approved Viagra quickly--perhaps too quickly" (Brownlee & Schultz, 1999).
In addition, FDA deregulation has increasingly allowed off-label uses for prescription medications. Off-label use was permitted by new regulations in 1982: "once a product has been approved for marketing, a physician may prescribe it for use or in treatment regimens or patient populations that are not included in approved labeling" (Ferenz, 1997, p. 41). Off-label uses were never promoted, however, until recently, when manufacturers became allowed to circulate off-label use information in exchange for promises that off-label purposes for the drugs would be researched. This situation would apply at the present time, for example, to prescribing Viagra for women. No research on women was conducted prior to the initial approval, yet because the manufacturer promises that such tests are underway, suggestive literature can be circulated.
Favorable Marketing Opportunities
Because a single blockbuster drug can lead to a significant realignment of market share, companies are increasingly attracted to "lifestyle" drugs (e.g., for weight problems, hair loss, memory loss, skin improvement, mood alteration) which appeal to large segments of the general public rather than merely to people with particular illnesses (Weber & Barrett, 1998). As the population ages, many more lifestyle drugs will focus on age-related issues. Almost every major pharmaceutical company has a fast-track program available for developing memory-enhancing drugs, for example (Hall, 1998). Although medical rhetoric surrounds all these drugs, company officials, when pressed, admit that they are fully aware of nonmedical uses of their drugs. As one such company representative acknowledged, "of all Prozac users--who buy about $1.8 billion of the drug each year--fully one-third have no medical need for it" (Hall, 1998, p. 56). A recent interview survey of over 2000 night-clubbers in northwest England showed that Viagra was already easily available for public nonprescription sale in clubs, and that people used it along with diverse other mood-altering and sex-enhancing substances (Aldridge & Measham, 1999). And, of course, there is the Internet as a marketing tool of inestimable proportions.
In sum, then, for a variety of converging reasons, recent political and economic developments favor the production and promotion of sexuality drugs by major pharmaceutical companies. But, they can't design, conduct, or evaluate the all-important FDA-approved research without the cooperation of experts on human sexuality.
WHY ARE SEX RESEARCHERS INTERESTED IN THE PHARMACEUTICAL INDUSTRY?
As an academic specialty, sexology has long suffered from failure to thrive, and thus it is not difficult to understand why sexologists might be enormously attracted and flattered by the sudden attentions of the pharmaceutical industry. To academic administrators and young graduates planning academic careers, sex research has always seemed too risky or "risque" to be a legitimate specialty. Furthermore, sex is a perennial battleground in the ultrapolitical culture wars, making sex research funding and academic welcome equally insecure. Consequently, sexology has limped along decade after decade with neither academic credibility nor dependable support.
Chronic Problems With Sex Research Legitimacy and Funding
The former editor of The Journal of Sex Research has noted that academia boasts few programs of sexuality studies, few tenured professors doing sex research, few job advertisements for sexologists, few research grants for sexuality studies, and few governmental agencies interested in sex research (Abramson, 1990). A recent overview of the state of sex research in the United States noted its historic limitations as a legitimate academic subject:
It is often assumed that it is not professionally legitimate to promote or
conduct sexuality research for the sole or primary purpose of contributing
to existing knowledge about human sexual behaviors in the social science
disciplines.... The primary outcome of such controversy lover research on
sexuality] has been the inconsistent and modest financial support for this
work on the part of both the government and the private sector, as well as
a hesitancy to publicly promote sexuality research. (DiMauro, 1995, p. 11)
Funding for sex research is subject to unpredictable political attack, as was shown recently when the Secretary of Health and Human Services abruptly blocked two large peer-reviewed and approved NIH sex research grants in response to conservative complaints (Laumann, Michael, & Gagnon, 1994; Udry, 1993). On the clinical front, summaries of sex dysfunction outcome research typically bemoan the lack of funding for randomized psychological treatment trials which would support strong claims about the efficacy of sex therapy (Heiman & Meston, 1997; Schover & Leiblum, 1994). As a result of such attacks and funding drought, sexologists are always on the defensive, worried about proving their claims, attracting talented students, and even about keeping their own jobs. Shrinking University Budgets
The enormous political and economic changes in academia discussed earlier have further pushed sexologists into the arms of the pharmaceutical industry. The former president of Stanford University recently reviewed the steady decline since the 1970s in federal and philanthropic science funding which occurred alongside the steady rise in the costs of science research (Kennedy, 1997). The loss of federal support has sent ripples throughout academia as universities have sought public and private funding for educational programs, athletics, student loans, salaries, buildings, and so forth. Nonremunerative programs in medical schools, including most sex therapy clinics, have been cut back and even cut out as for the first time faculty in medical schools have had to generate their own operating expenses and salaries (Schover & Leiblum, 1994). Slaughter and Leslie (1997) summarized how "colleges and universities try to compensate for diminished government revenues through liaisons with business and industry, through partnerships focused on innovative product development, and through the marketing of education and business services" (p. 1). This entrepreneurial Weltanschauung permeates current universities and medical schools, affecting sexologists along with everyone else.
Stagnation in Sex Therapy
The final reason some sexologists have been attracted to collaborative work with the pharmaceutical industry may be a certain lack of pride within their own clinical ranks (or is it just a high level of honesty?). In a thorough review of the field, Heiman and Meston (1997) concluded that if you use the most stringent standards, criteria published by a task force of the American Psychological Association, "There are almost no psychological treatments for sexual dysfunctions that conform to all the criteria of `well-established treatments'" (p. 148). They attribute this result to the absence of treatment manuals (a specific APA requirement for treatment evaluation), the lack Of control groups, the early domination of the field by the Masters and Johnson approach which delayed more testable approaches, and our old friend, miniscule funding for evaluation research.
Even so, Heiman and Meston (1997) concluded that effective psychological treatments for primary and secondary anorgasmia, erection failure, vaginismus, and premature ejaculation have been shown by numerous pieces of research. They believe that the psychological treatments for other complaints such as hypoactive sexual desire, sexual aversions, dyspareunia, and retarded ejaculation are less clearly effective, and that better diagnostic differentiation as well as treatment development are needed. However, in a point often overlooked, these authors are equally critical of the narrow research designs and assessment instruments used in the evaluation of medical treatments for sexual dysfunctions.
Schover and Leiblum (1994) took a more pessimistic look at the same situation a few years earlier. Critically assessing study results one dysfunction at a time, these authors suggested that sex therapy's effectiveness had been overstated, in part because biological factors may have been underestimated. Of course, these authors also discussed the impossibility of outcome research in a field without adequate funding. Looking more closely at the data in many of the studies with long-term follow-up, Schover and Leiblum (1994) reported that "the most striking finding was that the reversal of specific sexual dysfunctions was modest, but in each case series, most patients maintained improved overall sexual satisfaction" (p. 19). It may be that the value of sex therapy is obscured by research focusing strictly on symptom reversal and using the narrow language of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association. Broader, qualitative assessment might be more appropriate in delineating the efficacy of sex therapy.
Similar notes were struck in a 1992 review wherein a British psychiatrist praised early sex therapy research, and suggested that attending to the cognitive aspects of sexuality would improve the quality of sex therapy research at the present (Hawton, 1992). However, he gloomily continued, such research is lacking because funds are "virtually unavailable for research in sex therapy" (Hawton, 1992, p. 49).
For various reasons, therefore, sex therapists have found it difficult to produce the kind of unambiguous statistical results which would stand up in a contest of numbers to a medical audience used to evaluating outcomes by rates and percentages. In a widely publicized 1989 New England Journal of Medicine paper, urologists legitimated their rejection of the psychotherapeutic approach to treating men's erectile problems with the dismissive claim that "Only a few long-term follow-up studies of sex therapy have been performed, and they suggest a substantial rate of recurrence of impotence with time after sex therapy" (Krane, Goldstein, & DeTejada, 1989, p. 1654). The citation for this assertion was a summary paper in a urology journal which did not have a single citation to the sex therapy literature. Urologists have made the bold but highly self-serving and questionable claim over and over that their medical treatments are the most effective, and have effectively put sex therapists on the defensive.
Thus, one can see how the recent attentions of the pharmaceutical industry must have come as sunlight in winter to sex researchers. Its attractions included personal relationships with enthusiastic and flattering industry colleagues, a constant stream of paid trips to exotic and luxurious places, generous consultant fees, and business-class airplane tickets, all the standard modes of operation in the world of commercial science. Money for laboratories and research assistants, and released time from academic obligations also became available. Seductions and inducements blur with advantages and attractions, but one can see how they all represented a sea-change from the past straitened and stigmatized atmosphere of academic sex research.
HOW THE INTERESTS OF SEXOLOGY AND THE PHARMACEUTICAL INDUSTRY CONFLICT
Despite the mutual attraction between sexology and the pharmaceutical industry, there are several major areas where their interests conflict, perhaps irreconcilably. Some of these are conflicts which exist between the drug industry and all scientific or academic areas, but more importantly, there are numerous conflicts specific to the subject of sexuality.
General Conflicts of Interest: Secrecy and Scientific Integrity
The first conflict is over secrecy of scientific results. Industry interests lie in maximizing profit, and companies demand secrecy over information they see as essential to profitability. In recent years, in exchange for corporate funding and access to corporate products (e.g., preapproved drugs), academic scientists (following the practice of scientists employed within companies) have signed proprietary agreements which give corporations ownership over all research information (Blumenthal, Causino, Campbell, & Louis, 1996; Dickson, 1988; Marsa, 1997). Having signed, scientists cannot publish their studies or discuss their findings at scientific meetings without explicit corporate permission (Sindermann & Sawyer, 1997). This business rule, of course, conflicts with the normative structure of science (some would say the sacred obligation of science) wherein the free exchange of ideas is necessary for the growth of a common fund of knowledge, the critique of existing knowledge, and the dissemination of knowledge (Bradley, 1995; Liebenau, 1987; Schaffner, 1992). It's difficult to measure the impact of secrecy, although one suspects that companies are likely to embargo negative results more often than positive results. One British study using research projects approved by a particular institution's ethics committee reported a lower percentage of the pharmaceutical industry-sponsored research ended up published than the nonsponsored research (Wise & Drury, 1996).
Limitations on scientific communication are especially problematic in medical fields, where withholding or delaying information could cause harm. Failure to publish has already become a problem in sexology, insofar as early studies of the impact of Viagra on women, completed in early 1997, have not yet been published as of the date of this manuscript (personal communication, May, 1999).(2) Only one recent study of Viagra in women has been published, using a very small sample and no placebo group, and failing to demonstrate any therapeutic effect (Kaplan et al., 1999).(3)
Maintaining scientific integrity itself is a problem when scientific information is produced under commercial auspices (Bradley, 1995; Huth, 1992). How much does he who pays the piper call the tune--in other words, how much is the choice of methods and subjects, choice of literature to be cited, data collection and organization, and how results are reported and interpreted influenced by the company paying for the research? A recent newspaper expose revealed that scientific publications are increasingly ghostwritten by drug company medical writers (Eichenwald & Kolata, 1999), a shocking revelation to academics trained in the obligations and implicit promises associated with putting one's name on a publication. Journalists, patients, families of patients, students, researchers, and scholars all rely on published scientific studies to light their way into complex fields. If that domain is subject to commercial bias, scientific integrity is deeply compromised.
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.
Illustrative Example
A recent publication reported the effects of oral phentolamine on a small group of women with complaints about sexual arousal (Rosen, Phillips, Gendrano, & Ferguson, 1999). Phentolamine is an anti-adrenergic compound extensively tested and used in men with erectile complaints. The laboratory study on six women evaluated their vaginal pulse amplitude and self-reported arousal in response to erotic videotapes following medication or placebo intake. Both physiological and self-report changes following drug intake occasionally reached statistical significance but were highly variable, as is often reported in such research. It was hard to know what to conclude from this study, until one read:
our results should be viewed with caution until replicated in a
well-controlled, clinical trial. The purpose of this pilot study was to
provide "proof of principle" for the concept of vasoactive drug therapy in
the treatment of FSAD [female sexual arousal disorder]. (Rosen et al.,
1999, p. 143)
Proof of principle is a term for a step in the FDA's drug approval process, a curiosity in a scientific publication. In other words, the purpose of the study was to demonstrate that the compound caused effects, which would then justify further research. Much drug research is like this, driven by companies needing to establish a product's viability. The science moves farther and farther away from questions and designs motivated by theories about sexuality. Specific Conflicts Between the Pharmaceutical Industry and Sexology
In addition to general concerns about the undermining of scientific integrity as a result of relations with the pharmaceutical industry, there are at least five specific ways that sexuality research in particular would be diminished and threatened as a result of pharmaceutical industry domination. These arise in part because the goals of pharmaceutical research are ultimately pragmatic (to produce a saleable product), while those of sexology are intellectual; but more significantly, they arise because the model of sexuality used in sexology is broader, deeper, and more inclusive than the model of sexuality in industry-sponsored research.
Bypasses psychological and relational complexity of sexuality. The pharmaceutical industry approaches sex as a physical function, with adequate function of sex organs the bottom line. In typical fashion, for example, the 1989 paper on impotence defines the condition under study as "the consistent inability to achieve or sustain an erection of sufficient rigidity for sexual intercourse" (Krane et al., 1989, p. 1648). There's little attention to the person or couple attached to the penis, or recognition that relational factors might modify the meaning or importance of penile rigidity or sexual intercourse in a couple's sexual script. It would appear that industry-sponsored research wishes simply to wave away the complexities introduced by the psychosocial context of sexuality. By contrast, relationship theorists would argue that laboratory measurement of sexual organ function or self-report of organ function in the home setting offer a hopelessly incomplete sexual picture, and they would predict that drugs developed in such a bubble will be disappointing (Berscheid, 1999).
All current Viagra research proudly uses an "international" self-report questionnaire, the International Index of Erectile Function (IIEF), with impeccable statistical reliability and construct validity (Rosen et al., 1997). This 15-item instrument contains only one question inquiring about satisfaction with the sexual relationship with the partner, although even those results were omitted from the main Viagra report (Goldstein et al., 1998). Erectile dysfunction, a condition in the man's genitalia, has become the only acknowledged focus of interest, focus of evaluation, and focus of treatment. This represents a substantial narrowing from sex therapy--erasing the partner, erasing subjective meaning, and, ironically, perpetuating the obsession with penile hardness which many sex therapists have argued is itself a primary cause of sexual unhappiness.
Wise (1999) recently published two cases in which a couple's marital situation deteriorated following the prescription of Viagra. In neither case was the wife involved in any way in the prescription process. Schmidt (1993) argued that in the current sexuopharmacology research atmosphere,
No thought is given to the question of what meaning the man's impotence may
have for his emotional equilibrium or his relationship to his partner. If
something does not function properly, then it has to be repaired, as if it
were a bit of machinery. (p. 263)
Masks sociocultural factors. Because sexual function is treated as universal and biological in the pharmaceutical industry model, as witness the "International" IEF, cultural variation in sexual meaning or script are ignored. All erections are the same. Sexology, by contrast, has a rich literature emphasizing the diversity of sexual experiences, activities, and meanings around the world and throughout history. Sex researchers have examined power dynamics of sexuality, developmental continuities and discontinuities of sexuality, the embeddedness of sexuality within cultural systems of gender meaning, the connection of sexuality to leisure and to shifting notions of sexual orientation and gender identity, and so forth. All these issues are crucial to understanding the somato-psychics of sexual experience, yet all are ignored in the tidal wave of reductionism wherein sex is pelvic vascular function. In the wake of the product innovations for erectile dysfunction, it is no surprise that new women's pelvic vascular sexual dysfunctions have recently been announced by urologists, foretelling a wave of equal-opportunity pharmaceutical research (Goldstein & Berman, 1998; Park et al., 1997). Female genital dysfunction studies started appearing at conferences in early 1999, and although the data are described as preliminary, careful mention is made even in an abstract of how "this technique may prove useful ... in determining efficacy of vasoactive drugs in this [female] population" (Werbin et al., 1999, p. 178).(5)
Denies sex is socially constructed. Pharmaceutical industry-sponsored research relies on fixed alternative self-report questionnaires such as the IIEF which approach questions about sexuality as if they were factual and unambiguous. Sexologists, especially as a result of fifteen years of AIDS research, have learned that research questionnaires can themselves contribute to the social construction of sexuality by using language such as "intercourse," "sexual satisfaction," and even "get an erection" or "attempt sexual intercourse" in an unproblematic fashion. For example, when the first question of the lIEF asks "How often were you able to get an erection during sexual activity during the past four weeks?" how does the respondent decide whether a particular moment in a kitchen, bedroom, or movie theater constitutes sexual activity? Is anyone interested in the partner's role in the "getting" of the erection? Is anyone interested in whether the sexual activity during the past four weeks was of mutual interest to the man and the partner? Is anyone looking at how participating in a sex research study affected the sexual activity being counted?
Sexuopharmaceutical research treats people's sexuality the way ankle orthopedists treat dancers--completely ignoring how social and cultural processes shape experience and behavior. Now, no one argues that ankle orthopedists need to know much about social and cultural elements of dance to do useful research and intervention. But ankle experts don't describe their interventions as helping with "dance dysfunctions" or "disorders of dancing." And the doctors' role is further reduced because there are plenty of dance coaches and trainers to consult if one is interested in learning about or how to dance. But, sex is a different kettle of fish. There are few resources outside the medical model for people to easily consult. In treating sexual dysfunctions as asocial matters of physiology and bodily function, sexuopharmacological research promotes genital function as the centerpiece of sexuality and ignores everything else, disguising the larger contexts of social power (Gagnon & Parker, 1995).
Ignores connections of sex to politics. Feminists are not alone in connecting the reduction of sexuality to genital function to gender politics (Tiefer, 1994). Schmidt (1993) suggests that
Gazing at the diligence with which urologists, andrologists, surgeons and
physiologists pursue the dream of the `perfect penis' against the backcloth
of the social upheavals and the profound changes in gender relations and
sexual conduct of the last 20 years, one could conclude that the struggle
is not about restoring one man's potency, but a desperate effort to
re-establish western male potency in general. In fact it looks like a magic
rite symbolically guaranteeing the phallus's immunity from danger in the
face of a (slightly) changing power balance of the sexes. (p. 264)
Gender politics are invisible in sexuopharmaceutical research, but other political issues are equally neglected. Medical-model sex research such as that funded by the pharmaceutical industry mystifies sexuality with the technical (or pseudo-technical) language of "erectile apparatus" and "therapeutic management strategies" (Rivas & Chancellor, 1997, p. 429). Multisyllabic expertise intimidates and exploits people who lack sex education in a political climate where legislative politics has reduced public sex education to abstinence education. The current American culture combines limited sex education with constant in-your-face sexual sensationalism, stories of sexual violence and disease, and threats to safe and legal abortion. Thus, it should be no surprise that every study shows widespread public sexual ignorance and uncertainty. People are tongue-tied when it comes to reflecting on their own sexual motives or understanding the multitude of options for sexual decision making. Science and health media advise people with sexual dissatisfactions to consult medical experts, and in this way, the pharmaceutical industry benefits from the current politics of sexual ignorance and medicalization.
Threatens liberatory history of sexology. Finally, sex researchers have often allied themselves with liberatory sexual politics that endorsed sexual diversity and self-determination (e.g., Brecher, 1969). Throughout the twentieth century they have often challenged sexual restrictiveness and puritanical values. Feminism continued this tradition by revealing widespread sexual coercion and consequent sexual inhibition (e.g., Heise, 1995; Segal, 1994). The pharmaceutical industry is interested in increased sexual consumerism, but that is not the same as emancipatory sexual politics. Funded research thus far colludes with repressive traditions by excluding gay or single persons from drug trials and by defining satisfaction as the restoration of a phallocentric script. "Informed consent" in such research is a mockery in the face of participants' lack of comprehensive sexual knowledge. Sexual liberation seems limited to providing genital arousal and orgasm through chemistry. The emotional starvation of such sex research is the measure of the Faustian bargain of the sexologists.
STRATEGIES FOR SEXOLOGY TO RESIST A PHARMACEUTICAL TAKEOVER
There are many ways sexology can resist the domination of the pharmaceutical industry and preserve its independence in education, research, and the making of public sexuality policy.
Research Drug Consequences
Because pharmaceutical industry-funded research is likely to focus only on the most narrow, pragmatic, and technical effects of the sexuopharmaceuticals, it is incumbent on sexologists to train their lenses on three other types of drug effects: psychosocial impact, unintended consequences, and long-term follow-up.
Industry-funded research is generally short term. Of the four drug studies I cited in this paper, one had no follow-up at all as measurement was taken the same day as the drug (Rosen et al., 1999), one looked at effects for three months (Kaplan et al., 1999), one for four months (Salonia et al., 1999), and one for six months (Goldstein et al., 1998). Much of this follow-up time included continuing drug intake. The brief duration of drug study follow-up has been noted before, in contrast with follow-up studies of psychological interventions lasting up to five years after the intervention has ended (Heiman & Meston, 1997). Longer follow-up, especially when focussed more broadly than simply on symptom reversal, can reveal effects (both beneficial and detrimental, both anticipated and unforeseen) on sexuality and relationship factors.
The definition of drug effects to be examined is one of the most important aspects of research design. The widely used International Index of Erectile Function (IIEF), with its fixed response options in reponse to 15 questions, includes "Q1: How often were you able to get an erection during sexual activity? ... Q2: When you had erections with sexual stimulation, how often were your erections hard enough for penetration? ... Q3: When you attempted sexual intercourse, how often were you able to penetrate (enter) your partner? ... Q4: During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?" (Rosen et al., 1997, p. 829). In the report of the Viagra clinical trials, drug efficacy was telescoped to questions three and four only, reinforcing the message that the only issue that matters is organ function (Goldstein et al., 1998). In the 1999 study on Viagra and postmenopausal women, a new nine-item fixed-response questionnaire was adapted from the IIEF (Kaplan et al., 1999). Called the FSFI (Female Sexual Function Index), the questionnaire began with the sentence, "Sexual function includes intercourse, caressing, foreplay, and masturbation" (Kaplan et al, p. 485). However, none of the nine questions used the term sexual function again, referring instead to sexual desire (never defined), sex life (never defined), sexual relationship (never defined), sexual intercourse, and sexual stimulation (both defined). Even had the questions incorporated the broader language, however, the questions still would have neglected emotional experience, sensual pleasure, and personal sexual meanings.
Sexologists must use a broad range of quantitative and qualitative research approaches to measure the impact of sexual drugs on feelings and fantasies as well as functions. What did the users (patients and partners) of the drugs anticipate? How did they feel about the experience of using the drug? Whom did they talk to about the experience? What aspects caused lasting concern? How did the sexuopharmaceuticals affect feelings of gender adequacy, vitality, and desirability? What happened to the magical expectations? What was the impact of worry over side effects?
I was surprised to learn how secretive patients were about their penile prostheses in a follow-up study (one to four years post surgery) conducted some years ago (Tiefer, Pedersen, & Melman, 1988). The majority of interviewees, 52 men and 22 partners, had told almost no one about their prosthesis, despite numerous continuing stresses ranging from somatic obsessions to severe marital conflict. While intercourse was often frequent and patients were proud of their performance, men's sexual experience had become less sensual, and women reported ongoing worries over whether the penis would continue to "work." Both partners covertly checked the penis regularly. Sexual scripts were altered in about one quarter of the sample to eliminate partner oral or manual caressing. Open-ended questions revealed that the rewards of the prosthesis were often more psychological than functional (e.g., "I feel like a man again" said by patients not having sexual intercourse). To avoid promoting a mechanistic model of sexuality, it is incumbent on us to inquire about the broad emotional and interpersonal impact of sexuopharmaceuticals.
Challenge Inflated Epidemiology
It is in the interest of the pharmaceutical industry to publicize and inflate the prevalence of sexual dysfunctions,
a pattern [which] is emerging as a hallmark of the marketing of new
treatments. Medical crusaders draw attention to a disease by broadening its
definition to include the most mildly affected patients. That boosts demand
for new medicines-even for people who, in an earlier era, wouldn't have
been considered sick. Much as Prozac has helped turn even ordinary bouts of
the blues into a brain disorder treatable with drugs, the new ED [erectile
dysfunction] drugs promise to medicalize age-related sexual decline,
blurring the boundary between disease and discontent. (Stipp & Whitaker,
1998, p. 118)
These authors draw attention to the important role of epidemiological studies and epidemiological rhetoric in the sexuopharmacology story. The definition of sexual dysfunction is elastic, as inclusion criteria can be broad or restrictive. The only random population study on erectile dysfunction, for example, asked men aged 40 to 70 to characterize themselves as completely, moderately, minimally, or not at all impotent (Feldman, Goldstein, Hatzichristou, Krane, & McKinlay, 1994). The Viagra clinical trials paper cited the results of this study, but conflated all categories, as in "The [sic] disorder is age-associated, with estimated prevalence rates of 39 per cent among men 40 years old, and 67 per cent among those 70 years old" (Goldstein et al., 1998, p. 1397). Thus, the clinical trials report increased the prevalence statistics from what had been 10 million in 1989 (Krane et al., 1989, p. 1648) to 30 million in 1998 (Goldstein et al., 1998, p. 1397). Sexologists must recognize the elasticity of prevalence statistics and expose exponential growth numbers as part of industrial public relations. Recently, the answers to one yes/no survey question in a large, representative, population-based study of sexual practices (Laumann, Gagnon, Michael, & Michaels, 1994) were reanalyzed in a drug industry-supported study to emphasize the prevalence of sexual dysfunction, which was characterized as an "important health problem" in "urgent need for population-based data concerning [its] prevalence, determinants, and consequences" (Laumann et al., 1999, p. 537). The complex statistical manipulations require sophisticated examination, which is probably why the extensive media coverage usually went no farther than quoting the first sentence of the abstract's results, "Sexual dysfunction is more prevalent for women (43%) than men (31%)" (Laumann et al., 1999, p. 537). "Sexual dysfunction," as a single category, is probably as meaningless to a sexologist as "illness" might be to a physician or "ignorance" to an educator, but it is far from meaningless to marketers.
Thus far, sexologists have not challenged the escalating statistics. Perhaps this results from our long-held belief that sexual problems (including but far from limited to sexual dysfunctions) are common, but hidden, and that it would be a better world if people were more able to acknowledge and seek help for their sexual dissatisfactions. Benevolent intentions, however, can be co-opted by industry-related interests to increase market demand, and sexologists must monitor how their data, methods, and interpretations are used.
Resist Oversimplification of Sexuality
Pharmaceutical industry-sponsored sex research treats sex as a far simpler aspect of life than does sexology, a trend in evidence since urologists began to dominate erectile dysfunction discourse at the beginning of the 1990s. In response to the National Institute of Health's 1992 Consensus Development Conference Report on Impotence, sexologist-psychiatrist Bancroft commented, with admirable British understatement, that the report's discussion of psychology was "breathtakingly inadequate" (Bancroft, 1993, p. 205). Similarly, a Dutch psychologist-sexologist pointed out that "In the section on diagnostic procedures 14 lines are devoted to sexual history, and 77 lines to an evaluation of the anatomical and physiological substrate of sexual function," adding, "this is clearly out of balance" (Everaerd, 1993, p. 220).
The trend towards oversimplifying sexuality by ignoring or minimizing the psychosocial aspects is abetted by a dearth of sophisticated sexological research methods, a legacy of the shortage of funding and academic legitimacy discussed earlier. Survey methods are perhaps most advanced, driven by policy interests in sexually transmitted diseases and adolescent pregnancy (Bancroft, 1999). But even highly quantitative methods can explore sexuality as a part of social life, as shown in the important Chicago study (Laumann, Gagnon, et al., 1994). Also, numerous qualitative methods are emerging that will allow better research on relational factors in sexuality. For example, Clement (1999) recently described efforts to analyze and code narratives of sexual interactions as a new way to study sexual scripts, and Gavey and McPhillips (1999) used discourse analysis to examine women's contradictory feelings about condoms. Feminist research, with its emphasis on methods that allow individuals to use their own language and frameworks, will offer insights into sexuality in real life. Phenomenological and narrative research on sex therapy, for example, would make more visible the complexities of sexual relationships and allow sexologists to defend the complexity and range of sexual experience, as well as the central importance of meaning to the experience of sexuality.
We must recognize that part of the public appeal of the urologist-pharmaceutical industry model of sexuality is that bypassing sexual psychology holds out the hope of simple solutions and uses medical model language to relieve people of responsibility for their problems (Tiefer, 1986). But, people often suspect that this simplification is a trick, and I have found that presenting the complexity of sexuality in humanistic language resonates with people's wishes and romantic experiences, and engages their affect and imagination in ways that can overcome the appeal of reductionism.
Professional Education and Regulation
We have entered a new era of research ethics (Schaffner, 1992). Integrity guidelines have been established in many areas of funded research that can help researchers and funders alike (Bradley, 1995). These will continue to evolve as new questions are raised about conflicts of interest, academic publishing pressures, academic entrepreneurship, needs for disclosure, and so forth (Hersen & Miller, 1992). Sex researchers, newcomers in the world of commercial funding opportunities, need ethical and historical education about academic and scientific standards. Industry support of conferences and educational materials must be limited, as it seems that despite the language of "unrestricted educational grants," pharmaceutical representatives now attend sexuality conferences they sponsor and can intrude on participants' collegial experiences.(6)
Sexologists can play an important role in educating physicians about a role for the new sexuopharmaceuticals in the context of a more complex understanding of sexuality, although pharmaceutical industry sponsorship of such educational presentations would be problematic. Psychobiosocial sexuality research can be published in primary care journals along with lists of resource materials for physicians. Sexologists can develop consultation services to primary care physicians and committees to review sexuopharmaceutical advertisements. Professional sexuality research organizations can join the legion of scientific research organizations in developing, disseminating, and enforcing standards of responsible research conduct (Frankel, 1993).
CONCLUSION
With the advent of sexuopharmaceutical drugs and their tremendous public and commercial interest, sexology has entered a new era. I started by saying that this paper was an essay on family values, insofar as I see the professional and academic family of sexology threatened by commercial co-optation. Of course, this isn't the first time, nor will it be the last, that a family's values are threatened by the temptations of money. Either sexologists respond to the new ethical and methodological challenges by defending and promoting their own professional expertise, theoretical insights, and independent goals, or they will be co-opted by the powerful engine of commercialization. Collaborative research is possible, but only with equal attention to values based in the sexological paradigm. If sexology loses its independent status, the public will have even fewer places to turn for sexual enlightenment free from commercial or political bias.
(1) The first international conference of the International Association for the Study of Sexuality, Culture, and Society was held in Amsterdam in 1998; the journal Sexualities: Studies in Culture and Society began publishing in 1998.
(2) These data were finally presented in public for the first time in June, 2000. The senior author said that the company, which owned the data, had sent her preliminary information one week before the conference presentation, but that she still did not have access to all the raw data (Laan, et al, 2000)
(3) As of the July, 2000, copyediting date of this manuscript, several other small studies have been published.
(4) A recent editorial in The New England Journal of Medicine must be read by all interested in these academic-industry conflicts of interest (Angell, 2000).
(5) One year later, July, 2000, we are seeing such studies filling sessions at the annual American Urological Association conference, and the beginnings of a new urology subspecialty in female sexual dysfunction.
(6) Cf. my unpublished policy statement, "No free lunch: Recommendations for the Society for the Scientific Study of Sex regarding pharmaceutical company sponsorship, April 22, 2000."
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Manuscript accepted September 26, 1999
Leonore Tiefer New York University School of Medicine and Albert Einstein College of Medicine
This paper is based on a presentation to the International Academy of Sex Research, Sirmione, Italy, presented June 4, 1998. It was one part of a debate on "Sexology and the Pharmaceutical Industry: Collaboration or Co-optation?" which may account for its partisan tone.
Address correspondence to Leonore Tiefer, Ph.D., 163 Third Ave. PMB #183, New York, NY 10003;
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