It’s an ineffective drug for a disease that may not exist
Photograph: abodftyh
The mavens at Sprout Pharmaceuticals have smiles on their faces and coins in their pockets. Last month, their little pink pill hit the market, thanks to an astonishing decision by the Food and Drug Administration. Buoyed by poor science, conceptual confusion, and their successful hijacking of feminist concerns for women’s health, they are now selling a tablet, which, they claim, is a solution to women’s lack of sexual interest.
Their new drug, Addyi—the brand name for the generic flibanserin—is sometimes called female Viagra. This is a misnomer, since Addyi is believed to affect desire via neurotransmitter pathways in the brain, while Viagra affects the mechanics of intercourse by acting directly on penile blood flow. But the results are supposed to be similar: sexual pleasure where previously it was lacking.
The disease for which Addyi is a proposed treatment, hypoactive sexual desire disorder (HSDD), made its first medical appearance in the late 1970s and in 1980 was enshrined by psychiatrists in the third edition of the Diagnostic and Statistical Manual of Mental Disorders, or DSM-III. The disorder on which Sprout tested Addyi appears in DSM-IV, which describes the problem as a stress-inducing deficiency in sexual fantasies or desire for sexual activity in a person who is not otherwise impaired physically, mentally, or due to medication or substance abuse. Deficient compared to what, the reader may want to know. That is up to the clinician to figure out on the basis of vague guidelines. Testing done on Addyi’s efficacy relied on subjects recruited using the DSM-IV HSDD criteria.
Why did the FDA suddenly approve a pill aimed at women’s sexual desire after having rejected it twice?
More recently, however, a new edition of the psychiatric manual, DSM-V, has recast the disease by merging HSDD and something called female arousal dysfunction into a single malady: sexual interest/arousal disorder. The new manual lists eight possible symptoms, of which a patient must persistently express three over six or more months in order to warrant the diagnosis. These symptoms include absent or decreased sexual interest, such as erotic thoughts and fantasies; decrease or absence of initiation or response to partner’s initiation of sexual activity; decreased excitement and pleasure; and decreased response to sexual cues or sensations during sexual activity. So now we have a new pill to treat a disease that, technically, no longer exists. In fact the pill was proposed to the FDA as a treatment for lack of desire, but the disease for which it may be prescribed lumps together women who lack desire with desiring women who cannot experience genital arousal during sex. Oh dear.
Setting aside diagnostic concerns, is the drug effective? In their BEGONIA trial (there were also trials named VIOLET, DAISY, and SNOWDROP, the latter focusing on post-menopausal women), Sprout gave a group of women with HSDD either the drug or a placebo. Researchers used two metrics for success—increased desire, measured using a specially designed questionnaire, and increased quantity of sexual activity. For the latter an unimpressive 9–14 percent of women receiving the drug averaged 4.4 “sexually satisfying experiences a month,” compared to 3.7 for women who took the placebo, while 86 to 91 percent of the subjects showed no effect beyond that of the placebo. Results for the desire questionnaire showed positive changes of similar magnitude, a relief considering that the earlier flowers, which used a diary rather than a questionnaire to assess desire, showed no changes. Of course if it is true that 16 million women really have the DSM-IV version of HSDD—a figure often cited in the media and by the pill’s fans—then Addyi might help a million and a half women.
But there are side effects. Addyi interacts with garden-variety neurotransmitters, such as dopamine and serotonin, in areas of the brain thought to be sexual “pleasure centers,” but any drug affecting such ubiquitous and multipurpose brain chemicals seems unlikely to be very specific, suggesting that Addyi could have considerable unintended consequences. Using Addyi with alcohol increases the risk for severe low blood pressure and fainting, and the box label will clearly state the risk of alcohol use and similar interaction problems involving a long list of common medications, such as antifungals used to treat yeast infections. The FDA was so worried about side effects that it imposed a safety plan requiring doctors to complete an online certification test before permitting them to prescribe the drug. And in a strange twist, Addyi’s alcohol safety was tested on only twenty-five people, twenty-three of whom were men. Given that men have greater alcohol tolerance than women, the danger has likely been understated.
How is it that the FDA, which twice rejected Addyi, finally relented? (Oh, I forgot to mention that the day after FDA approval, Sprout sold out to Valeant Pharmaceuticals for about one billion cash plus a share of future profits.) The effectiveness of the drug did not improve between the last rejection and the recent acceptance, nor were the dangers of taking it reduced. What got better was Sprout’s rhetoric. Campaigns on Facebook, Twitter, in Congress, and at the FDA all aimed at shaming the agency into approval. Through an advocacy group called Even the Score, Sprout funded alliances with bean-counting feminists such as the National Organization for Women and the Society for Women’s Health Research. The basic argument was: men have twenty-six FDA-approved treatments for sexual health problems, and women only have one. Failure to approve meant that the FDA discriminated against women and thought men’s sexual health was more important than women’s. Who could stand up in the face of that?
Other feminists, ones who worry less about beans and more about substance and context, tried. One important voice, the New View Campaign, has been doing so since publishing its manifesto in 2000. Where others focus on medicine abstracted from real life, New View classifies women’s sexual problems into four major groups, only one of which concerns physiological problems that might call for pharmaceutical intervention. The other categories include political and cultural factors, partner and relationship issues, and individual psychological factors. New Viewers want social scientists and medical workers to consider, for example, the anxiety that results from poor sex education, obstructed access to contraception, and lack of treatment for sexual trauma and domestic violence. Sexual avoidance and distress can be the results of a perceived inability to meet cultural norms or of conflicts between one’s subculture and dominant cultural norms. In short, even when there is a physiological component to distressing lack of desire, New Viewers believe it cannot be properly treated if it is divorced from the social, cultural, economic, and personal contexts in which it occurs.
The New View Campaign, in coordination with the National Women’s Health Network, also visited the FDA, presented fact sheets, talked to members of Congress, and circulated petitions. But their socially and culturally embedded framework for understanding women’s sexual health made little headway. After the FDA vote, Cindy Pearson, executive director of the National Women’s Health Network, noted, “Every woman . . . is entitled to positive sexual experiences . . . without risking her physical health. Advocating for a libido drug that accomplishes that is not sexist. In fact, it’s feminist.”
Or, as the editors of The Onion wrote in an infographic satirizing the new pill:
Q: I’m a woman in my mid-50s in a loving relationship, but do not feel like engaging in sexual intercourse. Sometimes I feel as if my husband does not communicate how he truly feels about me or my body, and I have a hard time discussing this with him. Will this pill solve that?
A: Yes.