Skip to comments.F.D.A. Says Bayer Failed to Reveal Drug Risk Study
Posted on 09/30/2006 5:50:30 PM PDT by neverdem
WASHINGTON, Sept. 29 Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday.
Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.
In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the studys existence only on Wednesday. Preliminary results of the study demonstrate that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes, the advisory said.
Nevertheless, the agency did not change its advice about whether patients should be given the drug. Instead, it restated previous warnings that Trasylols use should be limited to patients in whom the risks of blood loss outweighed the drugs risks.
The disclosure comes exactly two years after Merck announced it was withdrawing its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attacks. Since then, members of Congress and even top scientific advisers have concluded that the F.D.A. lacks the regulatory authority and the money needed to detect and protect against drug dangers.
Drug companies have also been sharply criticized for failing to make public the results of some human trials of their drugs that suggest that the drugs are either ineffective or dangerous. Some lawmakers have proposed legislation that would require that nearly all human drug trials must be announced and their results disclosed publicly.
A top F.D.A. official said the agency learned of the Trasylol study on...
(Excerpt) Read more at nytimes.com ...
It's exactly because of things like this that I don't take any drugs other than a daily aspirin.
Just another of the thousands of reasons I will never trust the government when it comes to my health. It's a friggin' joke.
The FDA has legally killed more Americans (iatrogenic deaths) than any other department we have. They are so close and tied into the drug companies, that is why stuff like this happens. People leave the FDA to lobby for the drug companies, and vice versa. It's a royal scam.
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