FDA Delay Cost 22,000 Lives: Doctor

Agency took a year to pull lethal heart surgery drug Trasylol
By Jane Yager,  Newser Staff
Posted Feb 15, 2008 7:53 AM CST
The logo of pharmaceutical giant Bayer, manufacturer of Trasylol   (Getty Images)
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(Newser) – A prominent researcher who revealed widespread fatalities associated with the heart surgery drug Trasylol says 22,000 people died because of the FDA's delay in blowing the whistle on the drug after his study was published. Drugmaker Bayer also failed to disclose negative results of its own study. In a 60 Minutes interview to air Sunday, Dr. Dennis Mangano says the FDA waited more than a year to pull Trasylol—until after it was banned in Germany.

Mangano's study associated the drug, used to limit bleeding in heart surgery, with kidney failure. In September 2006, when Mangano presented his study to the FDA, Bayer defended the product. and failed to disclose the company's own earlier research, which confirmed Mangano's results. The FDA finally halted sales of Trasylol in November 2007. (Read more Bayer Pharmaceuticals stories.)