Last week, a small drug company called Sprout Pharmaceuticals announced that its version of “female Viagra”—a medication designed to enhance women’s libidos—was going back for yet another battery of tests. The Food and Drug Administration (FDA) wants more data on how Sprout’s drug, the whimsically named “flibanserin,” affects driving ability.
If this news sparked a little twinge of déjà vu, don’t be surprised. For more than a decade, pharmaceutical companies have trudged through round after round of clinical trials in pursuit of a drug that can alleviate some of the symptoms of female sexual dysfunction. Inevitably, a new set of tests makes headlines. Given Viagra’s blockbuster success since it was approved in 1998—in 2012, sales totaled more than $2 billion—there is a huge untapped market for a drug like flibanserin. More than 40 percent of women suffer from some form of sexual dysfunction in their lifetime. The most common complaint is hypoactive sexual desire disorder (HSDD), a fancy term for a lack of sexual appetite. Sometimes the root cause is psychological (think: Liz Lemon’s repressed childhood memories of Tom Jones), but in many other cases, it’s biological.
Men have a cornucopia of chemical solutions for their sexual problems to choose from; women, not so much. Looking a fix for erectile dysfunction? There are two-dozen FDA approved drugs to choose from. Seeking relief for HSDD? Nada.
The FDA has a double standard when it comes to sexual dysfunction drugs for men and women. Last year, Xiaflex—a drug that includes “penis rupture” among its possible side effects—got the FDA stamp of approval after being tested on fewer than 1,000 men. Meanwhile, flibanserin, which has been tested on more than 11,000 women over more than four years, returns to the lab for more trials.
“Right now, we’re telling women that sexual dysfunction is all in their head, and that really isn’t fair,” says Sheryl Kingsberg, the chief of behavioral medicine at University Hospitals Case Medical Center in Cleveland, Ohio. “There’s some underlying institutional sexism at play. The FDA is saying we need more driving trials because flibanserin makes women sleepy. But it’s a drug you take at bedtime.”
Flibanserin isn’t the only treatment that’s been forced through an endless gauntlet of tests. At first, the challenge was finding a way to evaluate female desire that was as effective as measures of male arousal. (It is, admittedly, easier to figure out whether a drug cures erectile dysfunction than whether it boosts sexual appetites.) In 2004, researchers for Pfizer all but threw up their hands, declaring that the psychology of desire was too complicated to measure. But since then, drug companies have developed a female sexual desire index that Kingsberg says is more useful than asking women how often they have sex. The problem isn’t that women with HSDD are celibate—many are in long-term relationships and report sexual activity a couple times a month. The issue is diminished lust. Women can have sex. That doesn’t mean they want it.
Researchers sometimes dismiss the problem by saying that chemical treatments can’t sway the psychological complexity of female sexuality. They point to the failure of Viagra as proof: If a drug that stimulates women’s genitals doesn’t make women want sex, what will? New treatments like flibanserin, however, fine-tune the libido in the brain. Flibanserin increases levels of dopamine and norepinephrine, two neurotransmitters that have been linked to sex drive. For most women in the trials, the treatment had a modest but statistically significant impact on sexual desire.
There’s a certain smack of condescension to the FDA’s continued refusal to approve flibanserin, an assumption that men are more capable of evaluating hazards than women. “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,” Anita Clayton, the chair of the psychiatry department at the University of Virginia, wrote on Huffington Post earlier this week.
In the past, some women’s health experts have expressed qualms about marketing a drug like flibanserin as a cure-all for low libido. Some women, they contend, might become convinced that their problems are biological, rather than psychological. Female sexual dysfunction is, after all, more psychologically complex than erectile dysfunction. But impotence isn’t purely mechanical either. Men who struggle with low desire are out of luck too. Viagra can help with an erection, but it has little power over the brain.
Our insistence on conflating arousal and desire sells both male and female sexuality short. “For men, there are psychological components to sexual dysfunction,” Kingsberg says. “For women, sometimes it’s biological. Wouldn’t it be nice if we could have a variety of options so a woman and her healthcare professional can sit down and figure out which would be the most useful option for her?”