February 24th, 2015
A pharmaceutical company hoping to develop the female version of Viagra resubmitted its drug for the Food and Drug Administration’s review on Tuesday — representing the latest major development in a years long fight that has pitted scientists against feminists.
This week marks the third time that Sprout Pharmaceuticals has sought FDA approval of flibanserin, a drug that aims to address sexual dysfunction in women. As the Associated Press reports, Sprout’s fight to get its female libido drug on the market “illustrates the complicated politics and unresolved science surrounding women’s sexuality.”
According to a frequently-cited number from a 1999 study in the Journal of the American Medical Association, more than 40 percent of U.S. women suffer from some type of sexual dissatisfaction. That’s what flibanserin wants to address. The medication is frequently referred to as the “little pink pill,” since it hopes to provide a female counterbalance to Viagra’s “little blue pill” that was first approved in 1998.
But FDA officials have so far declined to approve flibanserin for mass production because of concerns over its side effects, like levels of dizziness and drowsiness that could impair driving. Experts have also suggested that it isn’t effective enough to justify its potential risks. Critics, meanwhile, have accused the agency of gender bias, saying there are already more than 20 drugs on the market to treat male sexual dysfunction and the FDA’sreluctance to approve a drug for women suggests an implicit discomfortwith women taking control over their sexuality.
“We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women,” Terry O’Neill, the president of the National Organization for Women, told NPR this week. “And I fear that it’s that cultural attitude that men’s sexual health is extremely important, but women’s sexual health is not so important. That’s the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process.”
Last year, along with several women’s health nonprofit groups, Sprout Pharmaceuticals launched a high-profile advocacy campaign — Even the Score — to push back on FDA officials in explicitly feminist terms. O’Neill is one of the partners in that effort.
Even the Score has been circulating a petition declaring that “treatments for women’s sexual dysfunction seem to be held to a different standard for approval at the FDA.” Several U.S. lawmakers — including Reps. Debbie Wasserman Schultz (D-FL) and Louise Slaughter (D-NY) — have added their voices to the criticism, writing a letter to the FDA urging the agency to use “careful review employing the same standards of consideration given to the approved drugs for men in your risk/benefit analysis.”
People on the other side of the issue disagree, saying that it’s unnecessary and potentially even irresponsible to market a drug that claims to help women who are struggling with low libidos. Some behavioral health experts argue that women’s sexuality is too complex to be regulated with a pill, and the pharmaceutical industry is more interested in its own profits than in finding real solutions to nuanced sexual health issues.
“There’s really been a move toward medicalizing normal human experience,” Adriane Fugh-Berman, a Georgetown University professor who studies the influence of drug companies’ marketing practices on the medical profession, told NPR. “And while there are certainly some women who have very troublesome symptoms of low libido, it’s not at all clear that medication is a good answer for them.”
But proponents of the “pink pill” say that there’s been a concerted effort to downplay the number of women struggling with sexual dissatisfaction, even though there’s some evidence that it’s linked to issues with the neurotransmitters dopamine and norepinephrine. According to a recent review of the research published in the Atlantic, several studies have found that women diagnosed with Hypoactive Sexual Desire Disorder (HSDD) — women who have an “emotionally distressing” lack of arousal — have different brain activity, compared to the women who don’t have that disorder, when they’re shown sexually explicit images.
The FDA, which has been headed by a woman for the past six years, has repeatedly denied any gender bias in the agency’s decisions about flibanserin. It has also taken some steps to address the ongoing criticism in this area. This past fall, the FDA held a two-day conference dedicated to the issues standing in the way of a drug treatment for female sexual dysfunction.
But the debate isn’t likely to die down anytime soon. As part of its media push around the decision to resubmit flibanserin, officials at Sprout Pharmaceuticals have beenconnectingmembers of the media with women who say that they’re struggled with the consequences of sexual dysfunction, and desperately need their own version of Viagra.
“It’s got to be men making these decisions,” one of those women, Cara, who participated in a trial to test out flibanserin, told Marie Claire. “If it were women, this thing would’ve been on the market years ago.”