You're going to be hearing a lot about drug-eluting stents over the next week in the run-up to the Food and Drug Administration's advisory committee hearing weighing evidence about their safety. Here's a Reuthers report on the latest study from the Cleveland Clinic suggesting these tiny devices inserted in heart arteries to maintain adequate blood flow actually increase the risk of severe clots leading to heart attacks and strokes.
The report notes that it is widely rumored that the Cleveland Clinic's Steven Nissen, the president of the American College of Cardiology and a prominent drug safety critic who helped blow the whistle on Vioxx, has been named to the committee. Also on the panel, according to rumors: Eric Topol, who recently took a job at the Scripps Clinic in San Diego. Topol also worked at the Cleveland Clinic for many years and was part of the team with Nissen that wrote the 2001 paper warning about the risks from Vioxx, a warning the FDA and Merck ignored.
Next week's FDA hearing is shaping up as the most controversial this year. The agency has issued six waivers for conflicts of interest, an unusually high number for such a high profile meeting.
Posted by gooznews at November 29, 2006 09:36 PM