The U.S. Food and Drug Administration's approval of Addyi (flibanserin), a nonhormonal drug to treat low libido in women, has stirred up a great cultural and medical debate on just what defines “normal” human sexual desire. It is certain that many women struggling with lack of interest in sex who are diagnosed with hypoactive sexual desire disorder (HSDD), will ask for the drug once it becomes available this fall, and many physicians will be more than open to prescribing it. But not everyone views the approval as progress; some see it as a dangerous way to medicalize asexuality.
After an FDA panel in June voted to recommend the approval of flibanserin, a network of asexual activists (who call themselves ACEs)—led by the Asexual Visibility and Education Network (AVEN)—began a petition on Change.org that urged the FDA not to approve flibanserin. They argued that the drug, made by Sprout Pharmaceuticals, would turn a sexual orientation into a health condition that needs to be treated. Approximately 1 percent of the population identifies as asexual, according to a study published in The Journal of Sex Research. The organizers spread the word with the hashtag #DontDrugShame, and the petition garnered more than 1,500 signatures.
The writers of the petition took issue primarily with the condition for which the drug is meant to treat. HSDD is defined as low or absent sexual desire that is also accompanied by distress. The group has argued that such distress is too complex to treat pharmaceutically, since the shame that arises with a lack of libido is often tied to a fear of not conforming to social or cultural norms, as well as the fear of losing a romantic partner, intimacy and emotional support.
“Healthy women have simply been told by society, the media and their loved ones that they are broken,” says Cole Brown, who is on the board of directors for AVEN. “Now that flibanserin is approved and Sprout is preparing to train doctors on how to prescribe it, we would implore [Sprout Pharmaceuticals] to educate their prescribing doctors on asexuality and how it differs from HSDD.”
Sara Parker, who runs TheAsexualityBlog.com, is surprised that flibanserin was approved at all, given its history with the FDA. The regulatory agency twice denied Sprout’s application. She believes the FDA was finally forced to cave due to mounting pressure from grassroots groups that claimed denying approval would be a reflection of the agency’s gender bias since there are a number of drugs available for men to treat sexual dysfunction but none for women (until now).
She worries that people who identify as asexual will be coerced into trying flibanserin either by their partner or physician. “I feel like it perpetuates the mentality that sexuality and sexual desire is normal or mandatory in some way,” she says.
Like others who opposed flibanserin’s approval, Parker and her peers have also expressed concerns about the drug’s safety and efficacy. In clinical trials, the drug was found to cause dizziness, nausea and sleepiness, and it may be potentially dangerous when consumed with alcohol or combined with other medications.
In several studies, the drug’s efficacy was measured by the number of times a woman engaged in sexual activity once she began taking the drug and whether or not she felt less distress once she began to use it. Clinical trials show that flibanserin only increased the frequency of satisfying sexual events by two or three per month, though the researchers also found the drug reduced feelings of distress in many patients. But ACEs assert that this is bad science driven by a narrow view of sexual orientation.
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Pioneering sexuality researcher Alfred Kinsey asserted in his research that sexuality is a spectrum (what’s now known as the Kinsey scale)—and asexuality is somewhere on that spectrum. Today there is still a cultural dispute as to whether asexuality is a real orientation, or if people who identify as such may actually just be gay, but not ready or too fearful to identify as such. Additionally, the scientific community is split on whether asexuality is a normal variant of human sexuality or an indication of a personality or psychological disorder.
In a statement to Newsweek, Sprout says the research on flibanserin already accounted for the distinction between asexuality and HSDD: “Asexual individuals are not distressed, and therefore would not be a candidate for treatment with Addyi. Sprout is committed to educating healthcare providers about Addyi to help facilitate informed, educational conversations with their patients. With the five question screener, called the Decreased Sexual Desire Screener (DSDS), doctors can effectively rule out women who would not be considered for medical intervention.”
But because there is a limited acceptance of asexuality as a sexual orientation, most women grappling with low sex drive probably won’t self-identify when speaking with a doctor. This means a physician may be more likely to write a script or suggest the drug to their patient who is confused about her lack of sexual desire.
David Jay, who wrote the Change.org petition, says he believes Sprout’s advertising strategy will target women who identify as asexual, and who may be led to believe that they have a treatable disorder: HSDD. “The scary thing about this drug is that the disease it treats can be spread with marketing dollars,” he says.
Now that flibanserin is approved, some activists in the ACE community say they have turned to planning education campaigns that target medical professionals and sex educators in the U.S. to prevent misdiagnosis and mistreatment. Members of the ACE community say they hope to promote other approaches to handling distress tied to low desire, such as talk therapy.
“I'm all for people who want to get back to where they were,” says Parker. “But I don't think it should be fixed with pharmaceuticals, especially a pharmaceutical that has been questioned in so many areas.”