A federal advisory panel unanimously rejected a proposed drug to treat female sexual desire disorder, but did encourage a drug company to continue its research. The panel, the Reproductive Health Drugs Advisory Committee to the Food and Drug Administration voted against an application by Boehringer Ingelheim, a German pharmaceutical company, to market a failed antidepressant drug as a sexual desire booster for premenopausal women. The panel’s vote is advisory to FDA officials.Rico says obviously these women doctors obviously don't think there's a problem... (And, if there is, it's not hyperactive sexual desire disorder.)
Dr. Julia V. Johnson, chair of the panel and of the Department of Obstetrics and Gynecology at the University of Massachusetts Medical School, said the drug’s impact was “not robust enough to justify the risks,” which include dizziness, nausea and fatigue, particularly with long-term daily use. But she encouraged Boehringer to perform more research.
Dr. Kathleen Hoeger, a reproductive endocrinologist with the University of Rochester Medical Center and panel member, termed the research “incredibly important” but needing more work on long-term safety.
Boehringer’s proposed new drug, flibanserin, affects brain chemicals such as dopamine and serotonin thought to be involved with sexual drive. Indeed, the FDA staff found it had effectively increased the number of sexually satisfying events reported by more than 1,000 women with depressed libido in randomized, placebo-controlled experiments. But the staff found the drug had not been proven to increase women’s desire, a key element of the diagnosis, which involves low or no sexual interest causing distress in otherwise healthy people.
The diagnosis, called hypoactive sexual desire disorder, is itself controversial, although Boehringer last month mounted a publicity campaign about the disorder. A Boehringer official said it affects six to ten percent of premenopausal women, an estimate challenged by several speakers at the advisory committee hearing.
Boehringer will continue its research on the drug, a company official said after the vote. “We are disappointed with the advisory committee’s recommendations and will work with the FDA to address questions raised by the advisory committee,” Dr. Christopher Corsico, Boehringer’s United States medical director, said in a statement. The panel’s 11-0 vote was the second time in six years that an FDA advisory panel had unanimously rejected a drug maker’s attempt to treat a female sexual dysfunction. The FDA rejected a proposed testosterone patch from Procter & Gamble in 2004; that product was approved in Europe in 2006.
18 June 2010
Sure, bad idea for them
Rico says that Duff Wilson has an article in The New York Times that has pissed him off:
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