Wed, 18 Oct 2006 23:29:47 EDT
Harvard Prof Told FDA About Bayer's Hidden Study
It was Alexander Walker, a professor at Harvard University's School of Public Health, who first reported Bayer's failure to tell the Food and Drug Administration that an ongoing study showed serious safety concerns with its best-selling blood clotting drug, Trasylol, Bloomberg News reports. Walker was conducting the study for a private firm hired by Bayer. An FDA advisory committee met on September 21 to review evidence from two small trials that Trasylol, which is used to control bleeding during heart surgery, caused kidney failure, heart attacks and strokes. But the committee never heard about Walker's much larger, 67,000-patient study, which was first revealed to the FDA on September 29. Bayer conceded its failure to release the data in time for the advisory committee meeting was a mistake. Several advisory committee members told Bloomberg that the additional information would have convinced the committee to recommend that the FDA issue a stronger safety warning.
