The FDA’s Hesitation to Approve ‘Female Sexual Dysfunction’ Drugs Isn’t About Sexism

Article taken from March/April Newsletter 2015

The cultural impact and huge profitability of male-targeted impotence drugs has prompted a rapidly accelerating race to create similar drug treatments for women. Despite more than a decade of research and millions of dollars spent on development, the Food and Drug Administration (FDA) has yet to approve a single drug treatment for cis women dealing with so-called female sexual dysfunction (FSD). In response, the pharmaceutical industry has launched a campaign to persuade the FDA to approve such medications in the name of equality — a campaign that ignores the fact that most of the drugs under consideration simply don’t work. (“Cis” refers to “individuals who have a match between the gender they were assigned at birth, their bodies, and their personal identity.”1 To date, clinical trials for FSD drugs have only enrolled cis women who are in heterosexual relationships. The drug manufacturers’ and FDA’s limited concept of female sexuality is the subject of another article, however!)

This industry campaign, Even the Score (http://eventhescore.org), relies on the fact that drugs to treat FSD are less available than drugs for erectile dysfunction. Therefore, the campaign claims, the FDA is holding drugs for women’s sexual problems to a higher standard than men’s, and preventing women from making informed choices about their sexual health. (FSD is an umbrella term for a number of disorders, such as hypoactive sexual arousal disorder, female sexual arousal disorder, orgasm disorder, and sexual pain disorder.)

These tactics are working: Even the Score’s backers include FSD manufacturers as well as prominent women’s rights groups, reproductive justice groups, and many legislators, too.

No amount of slick marketing, however, can get around the fact that the FSD drugs just don’t work. There are many reasons why they may not effectively increase women’s sexual enjoyment — chief among them is the heterogeneity of female sexuality and the fact that sexual problems are mostly shaped by interpersonal, psychological, and social factors. Nevertheless, pharmaceutical executives continue to hype the possibility of a “pink Viagra”… because the potential market is estimated to exceed $2 billion annually.2 As this push continues, it’s vital to consider how much of the discussion around female sexuality is fact — and how much is fiction.

Fact: FSD is much less prevalent than FSD proponents like Even the Score claim it is.

Proponents who hope the FDA will to lower its drug approval standards are overstating the number of women suffering from FSD, putting it at 43 percent of all women. They believe that by making the “problem” seem widespread, the FDA can be encouraged to relax its standards. This claim first appeared in a 1999 Journal of the American Medical Association article and was based on an analysis of 1,749 women and 1,410 men’s answers to questions about their sex lives.3  Women who reported lack of sexual desire, difficulty in becoming aroused, inability to achieve orgasm, or anxiety about sexual performance within the last two months were deemed to have a sexual dysfunction. The researchers also noted that women were more likely to suffer from sexual dysfunction if they were single, had less education, had physical or mental health problems, had undergone recent social or economic setbacks, or were dissatisfied with their relationship with a sexual partner. In fact, these reasons that someone might be less inclined to become aroused have little to do with physiology. Since the report’s publication, scientists have rightly challenged its problematic conclusions.

Fact: There is no norm for female sexual function.

The implied parallel between female sexual dysfunction and male impotence is inaccurate and problematic. “Dysfunction” is just medical jargon for “something that doesn’t work the way it should;” it suggests that there is an acknowledged norm for female sexual function. But, this norm has never been established and probably doesn’t exist. Although male sexuality is more complex than sheer physical arousal, erections are quantifiable events that can be measured objectively. By contrast, cis women’s sexual responses are, by and large, qualitative, and difficult to analyze in clinical trials. And, as we know, sexual desire differs over time and between people for a range of reasons largely related to relationships, life situations, past experiences, and individual and social expectations. What is “normal” varies widely from person to person. Without downplaying the significance of any woman’s pain or distress, there is real danger in defining different as “dysfunctional.”

Fact: Female sexual dysfunction is not a defined disease category.

Without empirical standards by which to assess female sexual function, it is extremely difficult to generate effective treatment criteria for FSD. That hasn’t stopped drug manufacturers from trying, however. In fact, each time a drug sponsor claims to have a new solution for women’s sexual concerns, the “reason” for the dysfunction changes. Over the past 15 years, drugs affecting vaginal blood flow have been tested on women deemed to be suffering from FSD due to “insufficient vaginal engorgement.” Then, corporations and the media hailed testosterone patches as a magic bullet, because FSD allegedly resulted from hormone deficiencies. Most recently, re-purposed antidepressants have gained scientific currency, as women are being told that their low libido is due to a chemical problem in their brains.

Fact: Drug developers are not searching for a solution for women’s sexual concerns.

The pharmaceutical industry is driven by profits made from drugs. If a solution isn’t found in a pill, the industry is simply not interested. If product development-driven research occurred in a balanced context — with proportionate attention being paid to all causes of women’s sexual concerns — the focus on only biomedical causes and solutions would be less damaging. The focus on pharmaceutical over emotional solutions has serious limitations, and is unlikely to be effective. And, the industry’s presentation of FSD threatens to make women’s sexual experience a “performance” issue, much like it has with men’s.

Fact: There are 6, not 26, drugs approved for men.

Even the Score inaccurately claims there are 26 drugs approved for men, and none for women. But this claim is generated from counting every brand-name drug, and many of their identical counterparts, as unique treatment options, and artificially inflates the number of drugs available for men. Actually, there are six different FDA-approved drugs available for male sexual dysfunction.4

Fact: The standard for FDA review of male impotence drugs should not be the same for FSD drugs.

Even the Score’s gender equity argument is catchy, but ignores the real safety differences between the drugs tested for FSD and those already approved for men, including different dosages and administration. All but one of the drugs approved for men are taken on an as-needed basis, while the latest drug being tested for women, flibanserin, is used like an anti-depressant and taken daily. Sponsored by Sprout Pharmaceuticals, flibanserin is a central nervous system serotonergic agent with effects on adrenaline and dopamine in the brain; it requires daily, long-term administration. This raises toxicological concerns, and it is entirely appropriate for the FDA to subject this drug to elevated safety scrutiny. Substantial adverse events reports and dropout rates in the latest flibanserin trial also must be taken seriously.5

Conclusion

Women have answers to the age-old question, “What do women want?” We want, and demand, products that are rigorously evaluated, safe, effective, and meet our real needs. The Even the Score campaign’s effort to make this a conversation about gender equality is misleading and dangerous; although the FDA should be held accountable for gender equality, doing so should not compromise women’s safety by approving drugs that are neither effective nor safe. The FDA should continue to balance a serious and respectful incorporation of patient input while maintaining a rigorous, science-based review standard for drugs and devices it approves.

*Update* In late February 2015, Sprout pharmaceutical’s re-submitted a drug approval application for flibanserin to the FDA for the third time (the drug had previously been rejected by the FDA twice before). The National Women’s Health Network will continue to expose the tactics used by the pharmaceutical industry that misinform women about the safety and efficacy of their products and as such, we will monitor and evaluate the reapplication of flibanserin that is currently under FDA review.

 

 

Coco Jervis is the NWHN Program Director


References:

1. Schilt K, and L Westbrook, Doing Gender, Doing Heteronormativity: ‘Gender Normals,’ Transgender People, and the Social Maintenance of Heterosexuality,” Gender & Society 2009; 23(4):440-464, doi: 10.1177/0891243209340034

2. Clarke S, “’Pink Viagra?’ Drug Promises to Boost Female Sex Drive,” ABC News, Good Morning America, May 25, 2010. Available on-line at:  http://abcnews.go.com/GMA/OnCall/female-viagra-pill-promises-enhance-female-libido/story?id=10731882

3.Laumann EO, Paik A, Rosen RC, “Sexual Dysfunction in the United States: Prevalence and Predictors, JAMA 1999; 281(6):537-544. doi:10.1001/jama.281.6.537. Available on-line at:

http://jama.jamanetwork.com/article.aspx?articleid=188762

4.Bloom J, “Is The FDA Really Sexist?” Science 2.0, February 27, 2014. Available on-line at: www.science20.com/pfired_still_kicking/fda_really_sexist-130694

5. Food and Drug Administration, Summary Minutes of the Advisory Committee for Reproductive Health Drugs Meeting, June 18, 2010. Silver Spring, MD: Center for Drug Evaluation and Research, 2010. Available on-line at:  www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM248751.pdf