A medical researcher says that 22,000 patients could have been saved from preventable death if U.S. regulators had been quicker to remove from the market Trasylol, a clotting drug used to stop bleeding during open-heart surgery.
Trasylol was withdrawn in November 2007 after the Food and Drug Administration requested that it be pulled after a study linked it to kidney failure. The kidney failure was severe enough to require dialysis and it increased the likelihood of death by the patients who received it. Sales of the drug were suspended worldwide by its maker, German pharmaceutical manufacturer Bayer AG, following the FDA decision.
The researcher, Dr. Dennis Mangano, was interviewed on "60 Minutes" Sunday, Feb. 17th. Trasylol was used for many years and Mangano's study suggests that it was administered to as many as one-third of all U.S. heart bypass patients at the peak of its usage.
Mangano said that 22,000 lives could have been saved if Trasylol had been pulled from the market when he first published his study in January 2006.
Mangano said in the interview that Bayer didn't disclose to the FDA dangers with Trasylol that came up in its own studies.
2 comments:
If Dr. Mangano's analysis is correct, this may dwarf the vioxx debacle. It also calls into question the ethics and even the culpability of Bayer and the FDA. There is obviously a huge problem with our "system" which does merely a patchwork job of monitoring safety/outcomes of drugs.
Was there ever a study which compared the efficacy of Trasylol to Amicar?
This is really sad. The Plantiff's attorneys are licking their chops.
Thanks for your comment.
What's troubling is that drug makers sometimes notice problems with their drugs in testing, and they manage to bury that data or otherwise keep it from regulators until it's already affected many people... many thousands in this case, it seems. There are definitely holes in the system that's meant to protect consumers.
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