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What's New at the New View Campaign
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6/5/2015 |
Results of FDA Advisory committee flibanserin hearing 6-4-15 |
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The FDA's Bone, Reproductive and Urologic Advisory Committee and Drug Safety and Risk Management Advisory Committee voted on June 4, 2015 that flibanserin be approved with risk management options (such as prescriber certification) to be determined by the FDA at a later date. "Risk Mitigation Strategies," they are called, though Sid Wolfe of Public Citizen says they are poor substitutes for rejecting a drug! The discussion after the vote was recorded made it clear that even those in favor had serious reservations about the efficacy and safety of the drug. We wouldn't be surprised if a repeat vote would produce a different outcome. There was emotional backmail in the room from the Sprout-paid patients and ISSWSH-supported physicians to say that there were "no" treatment options doctors had to offer women with sexual desire complaints. Really? The vanishingly small number of trial participants who had had any exposure to psychotherapy was a clue that this was not a group with substantial or even any sex education. There are medications, but there are also books, videos, group discussions, couples and individual counseling and coaching approaches, etc. that have no dangerous side effects and have good outcome results. In the absence of any biomarker for "hypoactive sexual desire disorder" (which is no longer in the DSM, by the way, because the research can no longer support this "disorder"), it is a dangerous disservice to women to assume the validity of biological causation and pharmacological treatment. We will ask the FDA to override the Advisory Committees' decision and reject this drug. Read the coverage of this event, including our op-eds, on our Press page 2015.
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