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Television News Report Reveals Unsettling New Information on Trasylol Recall

By Alan Haburchak

Republish: EasyPublish™ Published: 14Mar2008 Word count: 696 Viewed: 342 time(s) Get Free Content For Your Site

On February 17th, 2008, the investigative television program 60 Minutes aired a segment on the prescription drug Aprotinin, marketed by Bayer as Trasylol. In the report, we are given the sordid 14 year history of the drug; from concerns before its Food and Drug Association (FDA) approval, an aggressive marketing campaign during the early years of its introduction to the market, to numerous fatalities resulting from common Trasylol side effects.

As far back as the early 1980's, the concerns over the potentially fatal side effects of Trasylol have been discussed. Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe incidents of kidney damage in animals given Trasylol. When he relayed the results of his research to Bayer, they disregarded the information, overlooking a potentially deadly Trayslol side effect. Soon thereafter, similar side effects showed up in patients given the drug in U.S. hospitals. Most common among the Trayslol side effects was acute renal failure, also known as acute kidney failure, resulting from damage to the kidneys. Cautious of it's continued use, Dr. Nicholas Kouchoukos, one of America's top heart surgeons conducted a small study on 20 patients given Trasylol. Of those given the drug, 13 had problems with kidney function after taking the medication. Ignoring these results and several other similar studies, the FDA approved Trasylol for use in 1993.

Through a relentless marketing campaign and intense pressure on the FDA, Bayer had all but cornered the market on Trasylol's use in all open heart surgeries, and was the favored drug to control bleeding in other major surgeries. Sales of the drug hit $300 million in 2005, with projected sales of $750 million for 2006. Dr. Dennis Mangano, a leader in the medical research field, was finishing a study around this same time, a study that had followed the records of 5,065 patients in 17 countries given Trayslol. Published in the New England Journal of Medicine in January 2006, this was the largest Trasylol study ever conducted and ultimately the most illuminating, suggesting not only an association between patients given Trasylol and acute kidney failure, but also an tendency for increased chance of death in the hospital.

When Dr. Mangano presented his results to an FDA advisory committee, the reaction was less proactive than he had imagined. Since Dr. Mangano's results were based on the hospital records of patients rather than a more traditional study involving a placebo, the committee was hesitant to comply with his request to remove the drug from the market. Unbeknownst to the committee, Bayer possessed the results from a study conducted by hired Harvard professor Dr. Alexander Walker, which looked at the records of nearly 70,000 patients in the same way that Dr. Mangano had conducted his research. Even more amazing were the startlingly similar results that Dr. Walker's study found: patients given Trasylol had an increased risk of acute kidney failure and death. Bayer's failure to inform the panel of their confirming results led Dr. Walker to contact the FDA, insisting that Bayer had deliberately withheld potentially damning information to continue lucrative sales of Trayslol. However, the FDA's only response to the confirmation of the fatal side effects was the issue of another warning to doctors; it would be a full year before the committee would reconvene to reevaluate to efficacy of the drug.

Meanwhile, a clinical study run in Canada in 2007 was halted when participants in the study group began dying. The German government immediately pulled and banned Trayslol; through a combined effort between the Canadian government and the FDA, Bayer was persuaded to put a temporary hold on the continued marketing of the fatal drug.

It is believed that approximately 4.5 million people have been given Trayslol worldwide; a third of those patients, about 1.5 million people, were given the drug in the United States in the 14 years the drug was available. By Dr. Mangano's estimates, if, in the brief time frame between his study and the most recent temporary moratorium on the drug, the drug had been taken off the market, it could have saved about 22,000 lives - approximately 1,000 people every month.

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