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Tuteur & Associates, LLC | Knowledge is Power.
February 15, 2008
Friday, 15 February 2008, 13:35 CST (RedOrbit) — An estimated 22,000 lives could have been saved if the Food & Drug Administration (FDA) removed the drug Trasylol from the market two years ago when evidence emerged implicating the drug in thousands of deaths, according to a respected researcher interviewed for an upcoming CBS 60 Minutes broadcast.
Trasylol, made by Bayer, is used to limit bleeding in heart surgery. At the height of its use, it was given to about a third of all heart bypass patients in the United States. The drug has always carried a warning of various side effects, including renal (kidney) effects.
The researcher, Dr. Dennis Mangano, told 60 Minutes correspondent Scott Pelley that Bayer also neglected to report to the FDA negative results of the company’s own internal study of the drug’s safety, and that this failure placed the drug’s success above patient health.
At the FDA’s request, the company suspended sales of Trasylol last year after a Canadian study of Trasylol was halted due to patient deaths. The study led health authorities in Germany, where Bayer is based, to ban all sales of the drug.
According to a CBS News report on its Web site ahead of next Sunday’s broadcast, Mangano said Trasylol should have been taken off the market when he published his study in January 2006. The study associated use of the drug with kidney failure requiring dialysis and increased death of those patients.
In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade the agency to pull the drug. Bayer senior executives attended the meeting to defend their product and had results from its own research confirming Mangano’s results. However the executives failed to disclose the existence of their own internal company study.
Continue reading, ‘22,000 Deaths From Delayed Recall of Trasylol.’