miércoles, 17 de septiembre de 2014
26:0 Frente a una FDA "sexista"..."Women’s Sexual Health Equity " y Sprout.
The U.S. Food and Drug Administration is sexist.
“There are 26 drugs for [sexually dysfunctional] men, zero for women,” said Irwin Goldstein, president of the Institute for Sexual Medicine in San Diego. “The FDA has gender issues.”
“Women’s sexual health is held to a different standard of risk-benefit by the FDA than male sexual health,” said Sheryl A. Kingsberg, a clinical psychologist at University Hospitals Case Medical Center in Cleveland.
That contention has been made for years by experts who are also paid pharmaceutical consultants. But over the last six months, the complaint has grown into a testy advocacy crusade. Even the Score: A Campaign for Women’s Sexual Health Equity* was launched last month by women’s groups, complete with a website (eventhescore.org), petition, and congressional supporters.
Although the website doesn’t explicitly say so, the impetus for the campaign was the FDA’s rejection late last year of flibanserin, a drug first tested as an antidepressant.
The FDA found flibanserin modestly effective at boosting libido, but worried about the once-a-day pill’s side effects, including dizziness, nausea, and sleepiness.
The maker, Sprout Pharmaceuticals, appealed the rejection in December. Soon afterward, representatives of eight women’s groups – including the National Organization for Women – had a tête-à-tête with FDA Commissioner Janet Woodcock.
“We were pleased, Dr. Woodcock, with your recognition that [the disparity in approvals] may signal gender bias, conscious or unconscious,” the groups wrote the FDA chief after the meeting.
Publicly, the FDA has denied any prejudice. But in February, the agency agreed to reconsider flibanserin. In exchange, Sprout agreed to do three more small safety studies. (Más)
Pharma Guy's insight:
Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.
Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!
Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo." I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.
(*) Sprout Pharmaceuticals figura entre sus "sponsors"