I will be soon.
"Weight-loss pill wins backing from FDA panel" February 23, 2012|By Deborah Kotz
SILVER SPRING, Md. - A Food and Drug Administration advisory committee voted 20 to 2 to approve Qnexa - a combination of the appetite suppressant phentermine and the seizure and migraine drug topiramate. The FDA turned down the drug in 2010 because of safety concerns over heart risks and birth defects.
After considering study data from following patients for two years, the expert panel determined that the weight-loss benefits outweighed the risks of two potential side effects: an uptick in cleft palates in children born to women who took topiramate while pregnant, and a modest increase in heart rate that could lead to heart troubles down the road. The 2010 decision was based on one year of data....
I would feel better about the risks if the fat measurement wasn't a phony so that you could get used to that growling stomach. If lies were food we would all be full, folks.
Advisory committee member Dr. Allison Goldfine, assistant director of clinical research at Joslin Diabetes Center in Boston, said she voted in favor of Qnexa because she sees the drug as filling a gap between bariatric surgery - which has its own set of risks - and diet counseling. But she added that she was still concerned about unknown safety risks and, like other panel members, she called for a postapproval follow-up study to be done.
Others, though, pressed for these studies to occur before Qnexa’s approval. “I’m concerned that a decision to approve the drug at this stage would be a mistake,’’ said Dr. Michael Lauer, director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute, who voted against approval. “There’s a real possibility that this agent may help people lose weight, yet it [may] wind up causing heart attacks, strokes, and a higher death rate.’’
Before the vote, members of the public, including obesity research advocates, spoke in favor of Qnexa’s approval, questioning why the FDA appears to be dragging its feet in recommending new obesity drugs when it does not have the same hesitation for, say, diabetes or heart drugs. “Obesity is not a condition of personal choice,’’ said Chris Gallagher of the American Society for Metabolic and Bariatric Surgery. “It should be subject to and evaluated by the same criteria as drugs used for other chronic diseases.’’
Where is all this obesity when nearly 20% of the people in this country are going hungry and most of the kids I see around here are as thin as rails?
Oh, right, I'm forgetting the spread at the one-percent buffet.
--more--"
