by Julia Belluz Follow @Juliaoftoronto
An FDA panel just backed the "female Viagra." Critics say it's a mistake.
- A panel of advisers to the Food and Drug Administration just recommended the agency approve a new drug designed to boost women's sex drives.
- Flibanserin — a pill dubbed the "female Viagra" — has already been rejected by the FDA twice since 2010 out of concerns that its harms outweigh its benefits.
- The 18-6 vote is considered a "major victory" for the drug, since the FDA more often than not adopts the advice of the expert group and same panel voted unanimously against flibanserin in the past.
- Critics have raised questions about the efficacy of flibanserin. They've also accused the pharmaceutical industry of inventing the medical condition — hypoactive sexual desire disorder — that the drug would supposedly treat.
American women may be one step closer to the "female Viagra"
Flibanserin (pronounced fluh-BAN-ser-in) is a daily pill made by Sprout Pharmaceuticals designed to treat low libido in premenopausal women. To date, the FDA has not approved it for sale — but the pressure to do so is growing.
On Thursday, a government advisory panel voted 18 to 6 to recommend that the FDA approve the drug — on the condition that Sprout can figure out how to minimize the safety risks to patients. That might entail requiring medical professionals to take a training course before being allowed to prescribe the drug, or making women who want the pink pills sign an agreement saying they won't use birth control or alcohol while on flibanserin (since these two behaviors increased the risk of side effects).
About one in five women who took the drug have experienced side effects: most commonly, low blood pressure, dizziness, and fainting, increasing the risk of injuries such as concussions.
While Viagra improves men's sexual performance, by increasing blood flow, the pink pill works on women's brains, raising dopamine levels.
It's not clear that the FDA will take the panel's advice, particularly since the agency has questioned the drug's effectiveness and safety in the past. As the New York Times reports, the results of clinical trials for flibanserin have been lackluster:
Three clinical trials testing flibanserin were consistent in their results. The women who took part were having an average of two to three of what they defined as "sexually satisfying events" per month when the studies began. Once they started taking the drug, the number of such events increased, but by no more than one event per month more than for women in the trial who got a placebo.
At the advisory committee meeting, the FDA gave a scientific presentation against the drug, arguing that it only resulted in eight more sexually satisfying events per year (when compared with a placebo) and that side effects were common.
But the room was also filled with emotional testimony by women who feel they would greatly benefit from the medication. Sprout claims nearly one-tenth of premenopausal women suffer hypoactive sexual desire disorder.
Critics say "pink Viagra" is a Big Pharma marketing sham
Not everyone's convinced that the drug is necessary, however. Some critics question whether low sex drive is even a real medical condition that can be treated by a pill — or just an invention of Big Pharma. The condition has been discussed in the scientific literature as "a textbook case of disease mongering by the pharmaceutical industry."
Although the evidence hasn't improved since the FDA's last rejection of flibanserin in 2013, the marketing push around the drug has gained traction: Sprout put together the "Even the Score" campaign accusing the FDA of being sexist for not getting the pink pill on the market to help women.
“"Marketing won over science today"”
As Paul Thacker described in Slate, the medical experts he spoke to agreed flibanserin is no "cure-all" and that the FDA has been evidence-based in its treatment of the pill. "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," one doctor told Thacker.
Dr. Adriane J. Fugh-Berman — the director of the PharmedOut project at Georgetown University — testified at the committee hearing, calling flibanserin "a mediocre aphrodisiac with scary side effects."
"Marketing won over science today," she told me afterward.
"The FDA presented a very good scientific case against the drug," Fugh-Berman said. "But the panel was convinced by the many women who had been brought there by Sprout to talk about the tragedy of their low libido, and how it was threatening their marriages. Several of them cried."
Read the original piece by Vox here.