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FDA Committee hearing on Flibanserin tomorrow (18 June) – how you can keep up with the meeting

Posted: June 19th, 2010 | Author: | Filed under: Briefs | Tags: , , , , , , | Comments Off on FDA Committee hearing on Flibanserin tomorrow (18 June) – how you can keep up with the meeting

Medical professionals have been warning against Flibanserin, a new drug created by pharmaceutical company Boehringer Ingelheim (BI) to address "hypoactive sexual desire disorder in women," or low sex drive. As Dr. Petra Boynton writes, "concerns have included the measures used to assess sexual satisfaction, the trials undertaken to assess the product, safety/efficacy questions, marketing strategies aimed at practitioners and the public, and the fact the research has not been made available within a peer reviewed journal. […] These issues are part of a wider anxiety over the increasing medicalisation of reduced female sexual desire."

Dr. Boynton and other practitioners have been critical of the blasé attitude with which mainstream media have treated their concerns, calling it "a pity that journalists covering this story could not have perhaps applied a more critical lens," and touting the use of Internet activism on blogs and Twitter for ensuring the FDA asks BI the tough questions.

Read brief source…

Update: Dr. Boynton has published a followup article that informs us of Flibanserin’s rejection by the FDA. She says, the FDA was “concerned about the materials used in trials to measure sexual response, the trial outcomes (which suggested Flibanserin did not perform much better than placebo) analysis of the data, and overall management of the trial. The FDA did not, however, dismiss HSDD generally and indicated it was a problematic condition they recognised.” Boynton details some lessons to be learned from the media coverage and reminds us that “we need to be aware that while there is now some critical coverage about the medicalisation of sexuality there is also a long way to go to get journalists to ask basic questions about drug company funded research in this area.”


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