The Sex Drug Chronicles: Flibanserin Evidence Too Flimsy for FDA Approval
By Christine Cupaiuolo — June 23, 2010
An FDA advisory panel last week unanimously recommended not to approve a new drug that purports to treat hypoactive sexual desire disorder (HSDD) in women, which is defined as “low or no sexual interest to the point of distress in otherwise healthy people.”
According to Julia Johnson, the panel’s chairwoman and head of the department of obstetrics and gynecology at the University of Massachusetts Medical School, the impact of the drug flibanserin (proposed trade name: Girosa), developed by the German pharmaceutical company Boehringer Ingelheim, was “not robust enough to justify the risks.”
Indeed, this is the point many women’s health advocates have stressed all along. The flibanserin trials were considered a success by Boehringer, but the results seem less than stellar.
In a study of 1,378 premenopausal women who had been in a monogamous relationship for 10 years on average, women were randomly assigned to take 100 mg of flibanserin or a placebo daily and to record daily whether they had sex, and whether it was satisfying. Via Time magazine:
Women in the flibanserin group self-reported 2.8 sexually satisfying events in the four-week baseline period; in the final four weeks of the 24-week study period, those women reported 4.5 sexually satisfying events, a more than 50% increase. Women in the placebo group reported an increase from 2.7 events to 3.7. The difference in effect between flibanserin and the placebo — about 0.8 sexually satisfying events — was statistically significant, the drug company said, and the side effects from the drug, which included dizziness and fatigue, among others, were mild to moderate and transient.
So women taking the drug had less than one additional “sexually satisfying event” (orgasm not required) than women taking a placebo. And in the meantime, the drug caused dizziness, nausea and fatigue, particularly with long-term daily use, in some women — hardly the recipe for sexual excitement.
The FDA also considered whether the drug had increased women’s desire — a crucial element of the HSDD diagnosis, which involves low or no sexual interest to the point of distress in people who are physically healthy and not depressed — and found that the drug failed in this area.
And that’s the trickiest part. Erectile dysfunction is treated by increasing blood flow to the penis, which leads to an erection. But for women, it’s not about being physically unable to have sex — it’s that there’s little interest in sex altogether, especially troubling when one has the same long-term partner.
The construction of this as a disorder is a classic case of “disease mongering,” according to clinical psychiatrist and researcher Leonore Tiefer. The hope for a female Viagra, one pill that will “cure” women’s sexual disease, ignores the social and historical context that has a tremendous effect on female attitudes toward sex and is often part of a larger attempt to medicalize the sex lives of women.
Time magazine’s Catherine Elton interviewed Judy Norsigian, executive director of OBOS, who outlined the concern:
Attempting to treat low libido with a pill ignores the fact that many women’s level of desire is deeply affected by everyday life stress and interpersonal relationships. Add to that a cultural milieu that at once promotes shame and ignorance about women’s sexuality while wildly inflating their expectations for sex. In many cases, says Norsigian, the proper solution to a lack of sexual desire would involve a number of non-drug approaches, such as therapy, mind-body techniques and getting partners involved in the solution.
“That could be equally successful while at the same time not exposing women to the [potential] long-term adverse effects of drugs,” says Norsigian, who suggests testing drugs like flibanserin against drug-free therapies. “Moreover, the non-medication approaches often address root causes for lack of libido and thus reflect a prevention approach that is usually much wiser.”
For similar reasons, the New View Campaign has been active in opposing flibanserin, as well as previous drugs such as Intrinsa, a testosterone patch from Procter & Gamble that failed to receive FDA approval in 2004. The Campaign provides several insightful fact sheets that explain the history and side effects of flibanserin.
Particularly revealing is the fact sheet on the marketing of flibanserin [PDF], which shows how Ogilvy Public Relations, on behalf of Boehringer, has promoted HSDD as a chief cause of women’s sexual dissatisfaction — through celebrities, celebrity sexuality experts and promotional websites. Most unsettlingly, Boehringer was able to sponsor and provide editorial input for a Discovery Channel documentary — “Understanding Female Sexual Desire: The Brain Body Connection” — which has acted, in its repeated showing on TV and the web, as an infomercial for the drug.
A better film to watch would be “Orgasm Inc.: The Strange Science of Female Pleasure,” a behind-the-scenes expose of the pharmaceutical industry’s flimsy construction of female sexual dysfunction as a curable disease and the attempt to develop and market a Viagra-type solution.
I am not surprised at all. I was following this and was curious about it, but when ever I looked at the testing results it just didn’t seem to do enough to make it worth while especially considering the side effects. I think something needs to be a little more potent and less side effects than it may pass.
Many women are not likely to want to take a daily medication for an event which (according to their research) at best happens once weekly. Female sexual desire stems from multifactorial issues and it is unlikely that any one pill will solve this issue for women. At least attempts are being made to help women with this issue…