The FDA’s Hesitation to Approve ‘Female Sexual Dysfunction’ Drugs Isn’t About Sexism
The pharmaceutical industry launched a campaign in January of this year to persuade the FDA to approve such medications in the name of equality—which overlooks the fact that most of the drugs being considered simply don’t work.
The cultural impact and multibillion-dollar profitability of male-targeted impotence drugs has prompted a rapidly accelerating race to create a similar drug treatment for women. Despite more than a decade of research and millions of dollars spent on development, however, the U.S. Food and Drug Administration (FDA) has yet to approve a single drug treatment for cis women dealing with sexual problems. In response, the pharmaceutical industry launched a campaign in January of this year to persuade the agency to approve such medications in the name of equality—which overlooks the fact that most of the drugs being considered simply don’t work.
This campaign, called Even the Score, hinges on the fact that drugs to treat so-called female sexual dysfunction (FSD)—an umbrella term for a number of disorders, such as hypoactive sexual arousal disorder, female sexual arousal disorder, orgasm disorder, and sexual pain disorder—are disproportionately unavailable when compared to those for erectile dysfunction. Therefore, the campaign’s supporters claim, the FDA is holding drugs meant to treat women’s sexual problems to a higher standard—which, they say, is preventing women from making informed choices about their sexual health. And their tactics are working: Even the Score’s backers don’t just include Sprout Pharmaceuticals, Trimel Pharmaceuticals, and Palatin Technologies, all of which have worked to develop medications for FSD. Its website also lists several prominent women’s rights and reproductive justice groups as supporters, and it has enlisted many legislators in the fight too.
No amount of slick marketing, however, can get around the fact that the drugs currently being proposed for FSD just don’t work. There are many reasons why the proposed drugs may not have been effective in increasing women’s sexual enjoyment; chief among them are the heterogeneity of female sexuality and, of course, research demonstrating that sexual problems are mostly shaped by interpersonal, psychological, and social factors. Nevertheless, pharmaceutical executives will continue to drum up hype over the possibility of a “pink Viagra,” because the potential market is estimated to be over $2 billion a year.
As this push continues, it’s vital to consider how much of the discussion around female sexuality is fact—and how much is fiction.
Myth: 43 percent of women suffer from female sexual dysfunction.
Fact: Even the Score and others urging the FDA to weaken its standards claim that there is an enormous unmet need for medical treatments for FSD. The claim that 43 percent of women suffer from a sexual dysfunction was first made in 1999 in an article published in the Journal of the American Medical Association. This “43 percent” figure emerged from an analysis of responses by 1,749 women and 1,410 men to a set of questions about their sex lives. 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 labelled as having 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—all reasons why someone might be less inclined to become aroused that have little to do with physiology. In the years since the report’s publication, scientists have revisited the validity of this study and rightly challenged its problematic conclusions.
Myth: There is a norm of female sexual function.
Fact: The implied parallel between female sexual dysfunction and male impotence is inaccurate and problematic. The word “dysfunction”—medical jargon for anything that doesn’t work the way it should—suggests that there is an acknowledged norm for female sexual function. That norm has never been established. Although male sexuality is more complex than sheer physical arousal, erections are quantifiable events that scientists can measure in objective terms. By contrast, cis women’s sexual response is, by and large, qualitative, and difficult to subject to clinical trials. Furthermore, as we all already 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—and “normality” can vary widely from person to person. Without downplaying the significance of any woman’s pain or distress, there can be real danger in defining difference as “dysfunction.”
Myth: Female sexual dysfunction is a defined disease category.
Fact: Without an empirical standard by which we can assess female sexual function, it is extremely difficult, if not impossible, to come up with an effective treatment criteria for FSD—which, again, is an umbrella term for many different disorders. But that hasn’t stopped drug manufacturers from trying. In fact, every time a drug sponsor claims to have a new solution for women’s sexual concerns, the supposed reasons for the dysfunction changes. Over the past 15 years, drugs affecting vaginal blood flow were tested on women who were 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.
Myth: Drug developers are searching for a solution for women’s sexual concerns.
Fact: The pharmaceutical industry is driven by profit. As such, if a solution is not found at the bottom of a pill bottle, its front-runners are simply not interested. If product development-driven research were happening in a balanced context, with proportionate attention being paid to all the causes of women’s sexual concerns, the focus on only biomedical causes and solutions might not be so damaging. The focus on pharmaceutical rather than emotional solutions has serious limitations, including the fact that they are simply unlikely to be effective. And the way the industry has shaped the FSD discussion threatens to make women’s sexual experience a “performance” issue, much like it has with men’s.
Myth: There are 26 drugs approved for men, and none approved for women.
Fact: On its website, Even the Score continues to inaccurately claim that there are 26 drugs approved for men, and zero for women. This claim perpetuates a miscalculation. It counts each brand-name drug and many of its identical counterparts as unique treatment options, which artificially inflates the number of drugs available for men. In fact, there are six different FDA-approved drugs available for male sexual dysfunction, including erectile dysfunction. Nevertheless, the inflammatory claim of gender bias has garnered press and political attention.
Myth: The standard for FDA review of male impotence drugs should be the same for FSD drugs.
Fact: Even the Score’s gender equity argument ignores the real safety difference between FSD drugs that are currently being tested and the drugs approved for men: a different indication for use, specifically the dosage and administration. All but one of the drugs approved for men are taken on an as-needed basis, whereas the most recent drug being tested for women is very similar to an antidepressant. 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 that make it appropriate for the FDA to subject that type of drug to an elevated safety scrutiny. Substantial adverse events reports and dropout rates in the latest flibanserin trial also need to be taken seriously. Women have answers to the age-old question, “What do women want?” Just ask us: We want and demand products that are rigorously evaluated, safe, effective, and meet our real needs.
Even the Score’s attempts to make this a conversation about gender equality are misleading and dangerous; although the FDA should be held accountable for gender equality, it should not compromise the safety of women’s health by approving a drug that is not effective and not 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 they approve.