On June 4, a governmental advisory committee recommended the FDA approve what has come to be known as “female Viagra,” or flibanserin. The committee voted 18-6 that the drug be approved, provided that certain safety measures be taken to reduce the risk of side effects.
The meeting marks the third time the FDA has reviewed flibanserin, a drug manufactured by Sprout Pharmaceuticals, designed to treat women with hypoactive sexual desire disorder (HSDD)—the lack or absence of sexual thoughts, fantasies and/or desire for sexual activity.
According to research provided by Sprout, the benefits are as follows: In three clinical trials, women who took flibanserin reported an increase of no more than one “sexually satisfying event” per month compared to women who took a placebo.
But there are significant risks. Women who took flibanserin experienced dizziness, drowsiness and nausea at a rate more than three to five times greater than those who took a placebo, and fatigue and loss of consciousness at a rate three times greater; over twice the number of women taking flibanserin stopped using it prematurely due to an adverse event than those taking a placebo; risks are amplified when flibanserin is combined with additional drugs and alcohol; and the “generalizability of the trial results” is unclear, considering the women enrolled in the trials were generally healthy, had no significant medical conditions and were prohibited from taking “an extensive list of medications and drug classes.”
The FDA raised similar concerns when it reviewed and denied the approval of flibanserin in 2010 and 2013. The data has largely remained the same, with the exception of an additional study requested by the FDA in 2013 to alleviate concerns about combining flibanserin with alcohol. Sprout submitted the study, but of the 25 participants 23 were men. That’s right—the company manufacturing a sexual enhancement drug for women tested its drug on a group of mostly men. According to a briefing document provided by the FDA, “[Sprout] reportedly had difficulty recruiting female subjects who were moderate drinkers.”
So what changed between then and now? How did the June 4 advisory committee come to recommend the approval of a drug that clearly has consequences and shows only marginal success?
According to many women’s organizations, it’s all thanks to the co-optation of feminist rhetoric by Even the Score, “a campaign for women’s sexual health equity” of which Sprout Pharmaceuticals is a member.
Even the Score claims the FDA has refused to approve flibanserin not for any of the reasons mentioned above, but because of sexism and gender bias. The organization says the FDA has approved 26 drugs to treat various sexual dysfunctions for men but none for women, and questions why drugs like Viagra can be approved when they also come with significant risk. Here’s one reason: While drugs like Viagra can cause serious side effects, more than 95 percent of patients who take it report improved ability to engage in sexual activity, whereas only about 41 to 62 percent of women taking flibanserin experienced a positive response (a sexually satisfying event or an increase in sexual desire). That’s compared to 29 to 49 percent of women taking a placebo during the flibanserin study—meaning the actual percentage of women who had a positive response to flibanserin was about 9 to 15 percent of those taking the drug.
“Sprout is trying to make the side effects sound similar to those we expect when we choose to take an antihistamine,” Cynthia Pearson, executive director of the National Women’s Health Network, who opposes the approval of flibanserin, told the Ms. Blog.
Women’s organizations that fear flibanserin poses serious safety risks for women attribute Even the Score’s success to its appropriation of feminist language. Dr. Thea Cacchioni, a sociologist at the University of Victoria who has been following flibanserin’s progress closely, even testifying against its approval at the 2010 hearing, told the Ms. Blog, “[Sprout is] using feminist rhetoric in order to sell products and trying to convince consumers that engaging with this product is a feminist issue.”
The drug’s opponents speculate that the committee’s recommendation for FDA approval was largely influenced by testimony from women who spoke of their frustrations living with low sexual desire. The women who testified insisted that even an extra eight sexually satisfactory events per year, seemingly the most that flibanserin could offer, would be enough to make taking the drug worthwhile. Yet only two of the 30 people who testified in support of the drug were women who had taken flibanserin, according to Dr. Anita H. Clayton of the University of Virginia School of Medicine, who attended the hearing as one of Sprout’s physician experts.
In an email to the Ms. Blog following the committee meeting, Cacchioni said that after listening to each FDA panel member’s explanation for the recommendation, members were not suggesting that the drug was very effective or safe, but instead “that they were convinced that the minor benefit was worthy of the risks based on the testimonies they heard from women.” The FDA has “set a very dangerous precedent,” she said, “that they will approve a drug they outright refer to as an ineffective one because of patient demand.”
Even the Score has turned the approval of flibanserin into an issue of choice—that women should have the right to decide to take a drug that may help them, even if it poses risks to their health. But the FDA has a responsibility to keep women safe, and putting a drug on the market whose risks are still very much unknown will probably help Sprout more than it will women.
“Women take risks all the time,” Pearson told the Ms. Blog. “Every time we take birth control, fertility drugs, medicine for hot flashes. But those risks are pretty well-known and pretty rare, and in this case, they’re not very well figured out yet, and they could have been.”
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