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Lynn McAfee KOs Qnexa in round oneAugust 8, 2010 The Council on Size & Weight Discrimination is pleased to report that Lynn McAfee’s testimony before the FDA Advisory Committee resulted in that group disapproving the new diet drug Qnexa. This is not speculation. After the vote, a member of the Advisory Committee went up to Lynn and said “You changed my vote, and you changed the votes of several other members.” Lynn, who is the Council’s Director of Medical Advocacy, testified that the new drug, Qnexa, a combination of Phentermine and Topomax, had not been proven either safe or effective, the two standards required for FDA approval. Phertermine is a stimulant and appetite suppressant, and was part of the combination drug Fen-Phen that was removed from the market in 1997 after resulting in numerous deaths from pulmonary hypertension. Topomax is an anti-convulsive used by many epileptics and often prescribed off-label as a weight-loss drug. The Council needs to send Lynn to the next two Advisory Committee hearings for new diet drugs, coming up in September (for Lorcaserin) and December (for Contrave). Although so far we have able to afford her transportation and housing costs, these hearings will be at a venue where a cheap hotel is not an option. The Advisory Committee is the only opportunity for consumer input. Lynn is the voice that reminds them that their job is to ensure the safety and effectiveness of all the drugs that come up for approval. We are asking our colleagues and supporters to help send Lynn to the FDA. As you know, the Council on Size & Weight Discrimination is an all-volunteer organization, and we operate on a shoestring. We do not often come to you with fund-raising appeals. This is a limited request, for just enough money to cover this trip. Our budget is $3,000. Any amount you can give will help us reach that goal, and help send Lynn to kick some FDA butt. The Council is a 501(c)(3) organization, so all donations are tax-deductible. You can donate online through Paypal by clicking here [Button]. Or you can send a check to CSWD at the address below. Thanks so much, Miriam Berg, President |
