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Friday, April 16, 2010

22,000 Trasylol Deaths Could Have Been Prevented

Trasylol is a drug that was used during by-pass heart surgery to prevent excessive bleeding as a blood-clotting agent. Bayer Pharmaceuticals Corporation in Cologne, Germany began producing and testing the drug in the early 1980’s.

Soon after testing began, Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found that when Trasylol was given to animals, it caused severe kidney damage.

Although he immediately notified Bayer about these side effects, Bayer ignored his reports and testing continued. When the testing stage reached humans in America, the same side effects were reported. Dr. Nicholas Kouchoukos at Missouri Baptist Medical Center conducted a study in 1992 and reported that out of the 20 patients tested, 13 of them suffered problems with kidney function after the procedure.

Other studies were done in other places without the same results, so in 1993 the FDA approved Trasylol for high-risk bleeders because all of the research conducted conclusively showed that it did control bleeding. It was noted that side effects included kidney toxicity, but that did not stop the approval.

The FDA asks companies to make sure their drug is safe before it is marketed, but mainly approval by the FDA is connected with it’s effectiveness. After approval of a drug, the FDA will investigate reports of problems with drugs and take action if necessary. In 1998, after years of Bayer pushing the drug very hard, the FDA expanded their approval for all heart by-pass patients.

Seven years later in 2005, Trasylol sales had reached $300 million. The following year, in San Francisco, Dr. Dennis Mangano, conducted a study of 5,065 patients in 17 countries. His research suggested that thousands had suffered complications and death due to a direct connection between the drug Trasylol and kidney failure.

Dr. Mangano’s findings were published in the New England Journal of Medicine. At this point, the FDA issued an advisory to doctors and planned a committee meeting to take place in about 8 months to discuss the safety of Trasylol.

Bayer wanted to be able to present their own report at that meeting, so they hired Harvard professor Dr. Alexander Walker to investigate the records of some 70,000 patients. Dr. Walker found that patients on Trasylol had an elevated risk of death and kidney failure.

In 2007, at the FDA committee meeting, Dr. Mangano presented his evidence and asked the committee to review the significant health risk involved in the use of Trasylol and asked the FDA to recommend that it’s use be discontinued.

Bayer’s senior representatives also attended the meeting and failed to mention anything about their own Dr. Walker’s findings. The problem the FDA faced was that Dr. Mangano’s study was not a clinically controlled study, which is a drug verses placebo study.

Rather, his research was conducted on real life hospital histories. Because of this and the fact that Bayer kept their own research hidden, the committee voted to keep Trasylol on the market. The following week, Dr. Walker went to the FDA and reported that Bayer had failed to present his study to the committee.

Another FDA advisory was issued to doctors, but they weren’t to meet for another year to discuss the safety of Trasylol based on the newly revealed study by Dr. Walker. In 2008, the Canadian’s conducted their own clinical trial of Trasylol. The study had to be abruptly discontinued because too many patients in the study died.

When Germany received word of this, they banned Trasylol and finally the FDA was able to persuade Bayer to suspend marketing. By this time, though, more than four and a half million people had received the drug.

Dr. Mangano reports that between his study in 2006 and November 5, 2008 when Trasylol was taken off the market, about 431,000 more patients received the drug and 22,000 of them died.

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