The FDA’s Rejection of Female Viagra Wasn’t Sexist. It Was Good Science.

What women really think about news, politics, and culture.
April 6 2014 10:15 PM

How to Handle FDA Rejection

Women’s groups are calling the FDA sexist for not approving female Viagra. They are so wrong.

female pill.
Is the absence of an effective "Viagra" for women a result of sexism?

Photo by Khuntapol/Thinkstock

When the FDA denied Sprout Pharmaceutical’s bid last October to begin marketing flibanserin, a drug aimed at treating low sexual desire in women, women’s groups responded in anger. In January, representatives from eight different women’s groups, including the National Organization of Women, met with Janet Woodcock, the FDA’s head of pharmaceuticals, to protest the decision. Congress also got in on the act, with Reps. Debbie Wasserman Schultz, Chellie Pingree, Nita Lowey, and Louise Slaughter sending a letter to FDA Commissioner Margaret Hamburg to implore that, when evaluating drugs for female dysfunction (in medical terms Hypoactive Sexual Desire Disorder, or HSDD), Dr. Hamburg apply "the same standards of consideration given to the approved drugs for men in your risk/benefit evaluation."

“We’ve now got 24 drugs for men for either testosterone replacement or erectile dysfunction,” Cindy Whitehead, Sprout’s chief operating officer told the Associated Press. “Yet there are zero drugs for the most common form of sexual dysfunction in women.” Anita H. Clayton, the interim chair of the department of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine, was more explicit, writing in a blistering column for the Huffington Post: “For the millions of women with HSDD, the FDA must overcome the problem of institutionalized sexism—unconscious and perhaps unintended, but damaging nonetheless.”

The chorus was loud and clear: The FDA is sexist. The federal agency charged with approving drugs to protect and improve our health is now standing in the way of a woman’s right to have a satisfying sex life. This framing played out in numerous stories, with similar charges appearing in the American Prospect (“the FDA’s kinda sexist”), and the Washington Post (“Some critics say the agency—consciously or not—may be succumbing to society’s squeam­ishness about women’s sexual desires compared with those of men”). Not to be outdone with mere institutional sexism, a writer for the Wire mused whether “blatant, medieval sexism is also at play.”

So where did the idea that sexism it to blame for the FDA’s rejection of flibanserin come from? It appears from Sprout itself.

Pharmaceutical companies have long been trying, and failing, to develop a pill to treat female sexual dysfunction. According to a study cited on Sprout’s website, “43% of women experienced some type of sexual dysfunction compared to 31% of men.” And the most common complaint from these women is low sexual desire. But, according to several medical experts I contacted for this story, the very idea that women can be cured from low sexual desire with a pill was created years ago by the drug industry. Flibanserin, they argue, is far from a cure-all.

“It is hard to see what is sexist about the national drug regulatory agency refusing to approve a drug that was ineffective and like all active pharmaceutical products, has the potential for harm,” says Barbara Mintzes an assistant professor at the University of British Columbia and co-author of the 2010 book Sex, Lies, and Pharmaceuticals: How Drug Companies Plan to Profit from Female Sexual Dysfunction.

Many of the doctors accusing the FDA of sexism have received some sort of monetary compensation from Sprout. Dr. Sheryl Kingsberg, chief of behavioral medicine at University Hospitals Case Medical Center and a vocal critic of the FDA’s rejection of flibanserin, told the American Prospect, “There’s some underlying institutional sexism at play.” She added: “The FDA is saying we need more driving trials because flibanserin makes women sleepy. But it’s a drug you take at bedtime.” In another story about the FDA’s rejection of flibanserin, Kingsberg blamed a double standard in society's "willingness to allow women to take any risk for improving their sexual health." Neither story disclosed that Kingsberg receives consulting fees from Sprout. Anita Clayton, who wrote that passionate HuffPo plea, is also a consultant for Sprout, which was not disclosed in her piece. And the International Society for the Study of Women’s Sexual Health (ISSWSH), which conducted a poll that found “[n]early two-thirds of women polled believe it's inappropriate that the score is 24-0 when it comes to federal approval of treatments for desire, arousal or orgasm dysfunction in men vs. women,” is also financially connected to Sprout. Not disclosed in the press release for that poll is that the group’s leader, Irwin Goldstein, director of sexual medicine at Alvarado Hospital, has also received funding from Sprout. (When I reached out to Sprout, the company confirmed that Goldstein, Kingsberg, and Clayton have been compensated by Sprout for their research and consulting services, and added that they believe in “the need for healthcare professionals to be open about their financial relationships with the healthcare industry.”)

Sprout says that while many groups have been vocal about the FDA’s rejection of flibanserin, Sprout executives have not made accusations of sexism at the FDA. The company has definitely been pushing the talking point, which organizations like NOW are repeating, that there are zero drugs available for women but almost two dozen for men. However, that’s a misleading claim: Viagra has several generics approved for use, but when you count actual active ingredients, there are really only a handful of available therapies for male dysfunction.

The lack of a magic pill to cure female sexual dysfunction has long been blamed on sexism, of some sort. “Any time a drug comes around as the female Viagra, that framing of sexism comes up,” says Amy Allini, deputy director of the National Women’s Health Network. “I think that Sprout has picked up on that and is trying to do something strategic. But it didn’t start with them.”

Allini’s organization sent a letter to the FDA urging the agency to not approve flibanserin because it failed to work and had serious side effects. “[W]hile the Network agrees with Sprout’s assertion that women deserve to have our problems with sex taken seriously, we do not believe that a minimally effective drug that must be taken daily, causes significant side effects and has not been evaluated for long-term safety offers women a serious solution,” the letter reads.

Former FDA official Susan Wood agrees. In 2005, Wood resigned from the FDA when the agency failed to approve Plan B—the morning after pill. She is now an associate professor at the George Washington School of Public Health and says the agency is doing the right thing with flibanserin. To counter the claim of sexism, Wood points out that there are many different pharmaceutical contraceptives available for women, but zero for men because of side effects. “One might argue that this is sexist. But the science is that it’s just more complicated for men and harder to develop a drug that’s safe and effective for long term use.”

It may go without saying, but perhaps needs repeating: Men are not women; women are not men. One might get confused on this issue when reading articles about “pink Viagra” or other comparisons of female sexual dysfunction to male sexual dysfunction.

But male sexual dysfunction is not the same as female. Drugs help men get an erection—a clinical endpoint that is quite easy to grasp. For women, the issue is low sexual desire, a complicated matter that involves a complex interplay of neurochemicals that affect behavior. “Women are more complicated, it’s not just increasing blood flow,” says Adriane Fugh-Berman, a physician at Georgetown University who directs PharmedOut, a nonprofit that educates experts about pharmaceutical marketing practices. “If you give women Viagra they will have increased blood flow and lubrication but they will not feel more turned on.”

Fugh-Berman says she has been tracking flibanserin since it first came up for approval. The drug was created by the pharma company Boehringer-Ingelheim as an antidepressant, but failed to get approval. Then Boehringer attempted to repurpose flibanserin as a drug for female sexual dysfunction, and was denied approval again. Sprout’s attempt to gain the FDA’s OK is the third time up for the drug.

Fugh-Berman is concerned that flibanserin may be another attempt to medicalize the female body, and Leonore Tiefer, associate professor of psychiatry at New York University, agrees, arguing that the very condition that flibanserin is trying to treat was created by the drug industry. In 2006, Tiefer published a piece in PLOS Medicine documenting the history of female sexual dysfunction as “a textbook case of disease mongering by the pharmaceutical industry and by other agents of medicalization.” In fact, Hypoactive Sexual Desire Disorder, which Sprout claims flibanserin treats, no longer even exists as a diagnosis. (Sprout responds that HSDD has been combined with another condition to create Female Sexual Interest/Arousal Disorder (FSI/AD). Women treated in clinical trials with flibanserin would meet this new diagnosis, they say.)

“A fascinating side to this story is the shift in the way that female sexual dysfunction has been framed depending on which drug is being promoted,” Mintzes says. “When Viagra was being tested for women, you saw press coverage that defined women's sexuality in terms of blood flow to the genitals; when testosterone was being tested, women's sexuality was defined in terms of hormonal problems; when flibanserin, a failed antidepressant, was being tested, it was a brain chemistry problem.”

And yet, with all this uncertainty, many women’s groups are sure that they know what the real problem is here: a sexist FDA that doesn’t care about women’s rights. In a coy manner to bolster these claims, Sprout pointed me to a recent statement released by NOW after the FDA rejected flibanserin. "The National Organization for Women has a long history of looking at the standards by which FDA approves drugs for women and there is clearly a bias here. When it comes to approving drugs for male sexual dysfunction, the FDA says yes with more limited research and serious side effects, but when it comes to women, their go-slow tactics are preventing us from having access to a treatment option where we make the decision in consultation with our healthcare provider," said Terry O'Neill, president of the National Organization for Women.

“It does speak to the shallowness of feminist understanding, that it’s all about rights,” Tiefer told me, commenting on flibanserin as a feminist cause. “What happened to the women’s health movement? We’ve been fighting so that women can be given good quality science, just like men.”

Some women’s groups are pushing back against the sexism claims. On Wednesday, nine women’s organizations representing health care providers, physicians, and scientists sent a letter to the FDA asking that they maintain an “evidence-based evaluation” and not bend to recent attempts to frame the issue along gender lines. “The problem with flibanserin is not gender bias at the FDA but the drug itself,” the letter reads. “Nevertheless, the inflammatory claim of gender bias produced press and political attention.”

For its part, Sprout says it is now working to respond to the FDA’s latest rejection and plans to submit two more trials later this year.

Paul D. Thacker is a former Senate investigator. He is a fellow at the Edmond J. Safra Center for Ethics at Harvard University, where he is working on a book about the lives of congressional staffers. Follow him on Twitter.

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