Here we go again: F.D.A. Says Bayer Failed to Reveal Drug Risk Study (from the New York Times). A snip:
- Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday.
Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.
Sound like Vioxx redux to anyone else?