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.

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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.”

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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.