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F.D.A. Panel Votes to Keep Diabetes Drug on Market
Key Excerpts from Article on Website of New York Times
Posted: August 9th, 2007
http://www.nytimes.com/2007/07/30/health/30cnd-avandia.html?...
A federal drug advisory committee voted 20 to 3 late this afternoon that Avandia, a controversial diabetes drug made by GlaxoSmithKline, raises the risks of heart attacks, but it then voted 22 to 1 that the drug should nonetheless remain on the market. Dr. Clifford J. Rosen, chairman of the committee [said] there was enough concern on the advisory committee that virtually everybody felt there was risk of heart attacks from taking Avandia. Patients who have congestive heart failure or a history of cardiovascular disease, or those taking insulin or nitrates should not be given Avandia, Dr. Rosen said. The votes came after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly disagreed with one another about the right course to take. Dr. David Graham, a drug safety officer at the F.D.A., called for the drugs withdrawal and estimated that its toxic effects on the heart had caused as many as 205,000 heart attacks, strokes and death from 1999 to 2006. For every month that Avandia is sold, he said, another 1,600 to 2,200 patients are likely to suffer from heart attacks and strokes, some of them fatal. Dr. Robert Meyer, director of the office within the F.D.A. that approved Avandias initial application, immediately disagreed with Dr. Graham. Dr. Douglas C. Throckmorton, a deputy director of the F.D.A.s center for drugs, explained at a news conference after the meeting that the split within the agency resulted from the complexity of the issue. The open disagreement within the F.D.A. reflects a fierce debate that has occurred among diabetes experts across the country since The New England Journal of Medicine published a study in May suggesting that Avandia increases the risks of heart attacks.
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