Trasylol Recall May Have Come a Bit Late: 20,000 Patients Too Late, a Researcher Tells 60 Minutes

Am starting to feel like the witch in "The Wiz" -- "Don't nobody bring me no bad news." A quick look at some headlines brought yet another story of blockbuster-challenged pharma ethics, this time involving Germany's Bayer AG. Next Sunday, CBS' 60 Minutes will interview Dr. Dennis Mangano, a researcher whose studies reportedly had found higher rates of kidney failure in patients who took Bayer's Trasylol, which is designed to stop bleeding during heart surgery. For more read on. His research came out in January 2006; the drug was recalled last November. In the interim, Dr. Mangano claims, 22,000 patients receiving the drug may have died needlessly. Dr. Mangano's study was the subject of an FDA advisory board panel meeting in September 2006, but Mangano says that Bayer did not disclose negative findings during that meeting, even though internal company research had confirmed the results. FDA advisory panel chair Dr. William Hiatt, reportedly told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer's study. AMS