This is huge...lawsuits for this will continue to mount...but why the delay in responding with the study is the big question? Was is profit over safety...a question that comes to mind...BD
NEW YORK (Reuters) - The lives of 22,000 patients could have been saved if U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding during open heart surgery, according to a medical researcher interviewed by CBS Television's 60 Minutes program.
The drug Trasylol was withdrawn in November at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients.
It had been given to as many as a third of all heart bypass patients in the United States at the height of its use over a period of many years, according to the report. He said in the broadcast that Bayer failed to disclose to the FDA during an FDA advisory panel meeting in September 2006 -- at which Mangano's negative findings were discussed -- that the German drugmaker had conducted its own research which confirmed the same dangers established by his study.