Abortion providers had hailed the revised label for Mifeprex as affirming a protocol they said they’d found safe and effective in practice.
By Sarah Kaplan June 1
There are 26 government-approved drugs to treat sexual dysfunction in men, but none for the most common sexual complaint among women. Is the FDA sexist when it comes to sex?
The activist group, Even the Score, thinks so. It and others pushing for Food and Drug Administration approval of flibanserin, often called “the little pink pill” or “female Viagra,” argue that the lack of libido-enhancing drugs for women reflects “persistent gender inequality” at the FDA.
“Women have waited long enough,” reads a petition to acting FDA commissioner Stephen Ostroff, signed by more than 55,000 people. “In 2015, gender equity should be the standard when it comes to access to treatments for sexual dysfunction.”
Backed by the drug’s developer, Sprout Pharmaceuticals, and 17 women’s and health organizations, Even the Score hopes to persuade an FDA advisory committee to recommend flibanserin for approval this week, the first step toward getting the drug on the market.
[‘Female Viagra’ finds difficult path at FDA]
But the campaign has plenty of critics, especially among women’s health experts, the very demographic that it hopes to harness. They say that the drug hasn’t been approved because of science, not sexism, and that claiming gender bias as the reason for its failure is a disservice to women.
Flibanserin has been touted as the antidote to Hypoactive Sexual Desire Disorder (HSDD), which Even the Score says affects one in 10 women. People with the condition say that they love their partner and want physical intimacy, but have lost their desire for sex due to a fluke of brain chemistry.
The drug works in womens’ brains to counteract that, increasing the effects of desire-enhancing chemicals like dopamine and decreasing the impact of inhibitors like seratonin, Sprout Pharmaceuticals CEO Cindy Whitehead told NPR. (In the 2013 release of the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders, the American Psychiatric Association merged HSDD with another condition into a single disorder called sexual interest/arousal disorder, but Sprout Pharmaceuticals says that flibanserin is still a relevant treatment for the new diagnosis.)
The mere existence of flibanserin makes it an anomaly, advocates of the drug say. At least six different treatments for male sexual dysfunction have been developed and approved since Viagra was first released in 1998. (Even the Score reports 26 treatments, but critics point out that many of them are variations on the same kind of treatment.) But drug companies have experimented in vain to find a similar quick fix for women. Part of the problem is biological — the main sexual problem reported by men is erectile dysfunction, mainly a mechanical matter of blood flow to their genitalia. But desire is a product of the complex interplay between hormones, brain chemistry and culture — much more difficult to manage by popping a pill.
Flibanserin has gotten further than any other proposed solution toward becoming an actual drug on the market. Pfizer, which manufactures Viagra, ended its research on a female version of the drug in 2004, according to the New York Times. And Boehringer Ingelheim, the German company that first developed flibanserin, gave up on the drug after it was initially rejected by the FDA in 2010. Sprout Pharmaceuticals then acquired flibanserin in hopes of becoming the first manufacturer of a women’s libido-enhancing drug.
Trials of the drug have demonstrated modest but statistically significant improvements in women who have HSDD. A 2013 study published in the Journal of Sexual Medicine found that women who were treated with the drug had one more “satisfying sexual event” over the course of a month than those on a placebo. And the Internet is full of testimonials from women who have used the drug and say it changed their lives. “It was as if someone turned a light switch on; suddenly my desire for sex returned,” Amanda Parrish, a married 52-year-old sales representative from Indiana wrote in Salon.
But the drug, which must be taken daily, has side effects, including nausea, dizziness and drowsiness. It’s already been rejected twice by the FDA, once in 2010 and again in 2013. In January 2014, the agency asked for further safety tests on the drug, determining that the potential risks outweighed its “modest” impact on sexual satisfaction.
The decision frustrated advocates of the drug, who believed that the FDA was holding drugs for women to a much higher standard than those for men. After all, Viagra can also cause nausea and dizziness, as well as vision changes, muscle pain and dangerous prolonged erections. And it was approved on a fast-track status, according to CNN. Did the FDA reject flibanserin because it was squeamish about female desire?
“It looks to me like there are more hurdles being put in front of this drug than there have been on drugs addressing male dysfunction,” Terry O’Neill, president of the National Organization for Women, told The Washington Post after flibanserin was rejected a second time. “Obviously, everyone only wants drugs to get on the market if they are proven safe and effective. But we don’t want attitudes to get in the way of a good drug.”
Anita H. Clayton, a sexual health specialist and interim chair of the University of Virginia’s psychiatry department, put it more bluntly.
“The FDA has set a very high bar to measure the risks and benefits of a medical treatment for [female sexual dysfunction], as if women do not have the capacity to make informed medical decisions,” she wrote in an analysis for the Huffington Post last year.
On the other hand, supporters of the FDA decision argued that accusing the agency of sexism was at best a misunderstanding and at worst a ploy to persuade the agency to overlook the drug’s flaws.
“Any time a drug comes around as the female Viagra, that framing of sexism comes up,” Amy Allini, deputy director of the National Women’s Health Network, told Slate (Allini’s group was one of nine health organizations that co-signed a letter in support of the FDA last spring). “I think that Sprout has picked up on that and is trying to do something strategic. But it didn’t start with them.”
Even the Score, which launched last summer after the second FDA rejection, has rekindled the debate, this time with a cadre of feminist and women’s health groups on its side. The campaign counts among its supporters the National Council of Women’s Organizations, an umbrella group that includes NOW and NARAL, and a host of women’s health groups. It has a raunchy ad parodying a Viagra commercial.
In March, 11 members of Congress chimed in with a letter to the FDA, applauding the agency for a recent workshop on female sexual dysfunction and urging it to focus on “providing women with safe and effective treatments they need and deserve.” Sprout Pharmaceutical has also submitted two additional safety studies of flibanserin, Buzzfeed reported.
But the Even the Score effort continues to sit uncomfortably with women’s health experts. Many point out the problem with the campaign’s health claims — that it’s inaccurate to compare erectile dysfunction and HSDD, that it ignores the FDA-approved treatments of other female sexual health issues, that it glosses over side effects in the name of gender equality. And others say that the campaign is pathologizing women’s sexuality, rather than supporting it.
“This approach assumes that there’s a certain sexual drive that’s normal and that if a woman is interested in sex less than that, then that’s abnormal. … It seems to me that that’s wrong,” Barbara Mintzes, an assistant professor at the University of British Columbia and co-author of the book “Sex, Lies, and Pharmaceuticals: How Drug Companies Plan to Profit from Female Sexual Dysfunction,” told BuzzFeed News. “That certainly isn’t the way that you work towards sexual equality.”
Writer Amanda Marcotte, who blogs about feminism and women’s issues, pointed out in Slate that although female sexual desire is often overlooked, flibanserin is hardly a radical challenge to traditional sexual norms. It’s been marketed as a way to help women have more sex with their husbands — a fairly conservative endeavor. Looking at the non-chemical causes of HSDD — the fact that everything from clothing to porn is designed with male desire in mind, that declining libido is associated with monogamous relationships — is a lot more challenging, but more worthwhile, she said.
“It’s easier to endorse the idea of ‘equal’ pills rather than to open up a conversation about remaking our social conception of sexuality so that female desires play a greater role,” she wrote. “But if feminists aren’t willing to start that conversation, who is?”