More Avandia News

FDA to assess cardiovascular risks with Avandia in patients with diabetes.
ABC World News (2/22, story 9, 0:30, Sawyer) reported that "the FDA said it is reviewing" diabetes drug "Avandia [rosiglitazone] for possible risk of heart attack. Over the weekend, a Senate report said the drugmaker, GlaxoSmithKline, knew of the possible danger for years. One report raised a possible connection to 83,000 heart attacks between 1999 and 2007."
The Senate report also "concluded that [Glaxo] had threatened scientists who tried to point out Avandia's risks," the New York Times (2/23, D1, Harris) reports. In one instance, Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, met with "four company executives" after Nissen "conducted a landmark study that suggested...Avandia raised the risk of heart attacks." Nissen "said...that the executives hoped to persuade him not to publish his study by suggesting that they had contradictory information they would share with him in a joint study."
Still, the FDA "said...that for now, patients should not stop taking" Avandia, USA Today (2/23, Rubin) reports. The agency "said it was reviewing data received in August from...a large, long-term, company-funded study designed to assess Avandia's cardiovascular risks in patients with type 2 diabetes." An advisory panel is expected to meet in July. But, Endocrine Society president Robert Vigersky said that "everybody's best interest would be served" if the meeting were held sooner. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said, "We feel that it is time for a thorough evaluation of all the cardiovascular risks with that drug."
The Wall Street Journal (2/23, Mundy, Favole) reports that Vigersky questioned the agency's delay in reviewing data that it received last year. Meanwhile, Woodcock said that although "some individuals within the FDA continued to believe...that the drug should be withdrawn," the agency lacks any "new information that raises additional alarm about the drug."
The Forbes (2/22, Mintz) "The Science Business" blog noted that the FDA is reviewing data from a study published in the Journal of the American College of Cardiology that "showed that when giving Avandia to patients with class 1 and 2 heart failure," the drug "did not statistically increase the rates of heart failure, death, or heart attack."
The Senate report "also pointed out...that FDA safety officers are under the control of officials who approve new drugs," CQ HealthBeat (2/23, Reichard) reports. Grassley said, "It doesn't make any sense to have these experts, who study drugs after they have been on the market for several years, under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision." Reuters (2/23, Richwine), HealthDay (2/23, Mundell), MedPage Today (2/22, Walker), and Dow Jones Newswire (2/23, Favole, Munday) also covered the story.