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July 8, 2008
The Trasylol Story Illustrates Why FDA Preemption is Bad Public Policy
The crux of the argument that FDA approval of a drug should preempt state lawsuits over that drug is that it should be experts at the FDA who decide whether a drug is safe and what warnings that drug’s label should carry. Implicit in this argument are the assumptions that the FDA has access to the information it needs to make expert decisions and that it will make its decisions quickly when lives are at risk. The Trasylol story proves these assumptions to be false.
Aprotinin is a naturally-occurring enzyme produced by cows. It was first discovered in the 1930’s, and brought to market under the name Trasylol by Bayer in 1959. Trasylol increases the rate at which blood clots, and Bayer sought FDA approval to use the drug during Coronary Artery Bypass Graft (CABG, pronounced cabbage) surgery to reduce blood loss and minimize the need for blood transfusion.
The FDA mistakenly approved the usage of Trasylol in 1993, and it rescinded that approval in 2007 after mounting evidence showed the drug was causing patients to suffer from renal failure, have strokes and heart attacks, and even die within thirty days of using the drug. The total number of lives lost to Trasylol will never be known, but at least one researcher has pegged the death toll at 1,000 lives per month during 2006/2007.
Bayer Ignored Evidence That Trasylol Caused Renal Failure
Trasylol had been available in Germany (Bayer is a German company) since 1959, and a number of prominent German researchers began to suspect that Trasylol caused kidney problems as early as the 1970’s. One such researcher was Dr. Juergen Fischer, the Director of the Institute for Experimental Medicine at the University of Cologne. In the early 1980’s, he went to Bayer with evidence of Trasylol’s kidney toxicity. 60 Minutes interviewed him about his experience with Bayer and he stated that “I felt that Bayer wasn’t interested to examine these side effects” of Trasylol. This is actually an understatement.
It appears that Bayer actually tried to hide information about those side effects. In 1984, Bayer held a symposium in Luxembourg entitled “New aspects of the TRASYLOL therapy.”
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