Here come the lawsuits
Bayer is now facing the wrath of thousands of patients and their families.
And rightly so. It's yet another appalling case of a drug company knowing that their drug, in this case, Trasylol, is dangerous. But instead of coming clean, they decided to brush the data under the rug. Bayer's failure to disclose to the FDA the results of a study showing the dangers resulted in 22,000 deaths that could have been prevented, if only it had been pulled from the market as soon as they had the data—or never put on the market in the first place.
Trasylol has been used with patients who have undergone open-heart surgery. It's a clotting agent that stems bleeding. Its use on the market was suspended this past November, because it was linked to kidney damage and failure, the need for dialysis, and the increased risk of in-hospital death. The FDA was unable to find any segment of the patient population in which the benefits outweighed the deadly risk factors. And still, the FDA said that if a physician happens to have a patient they feel could benefit from Trasylol, they could continue to get it.
So "no one can benefit from it, but if you find someone who can, use it"? Is that the best the FDA can do? But let's not underestimate the amazing creativity mainstream medicine can drum up when it comes to defending bad drugs.
For years the drug has been given to up to a third of all the patients who had open-heart surgery. An observational study was published in January 2006 stating what the risks were. Bayer also completed a study during that time period which found the same results.
But the information from both studies never made it to the light—or into doctor's hands, even when they had the opportunity during an FDA advisory panel meeting that occurred in September of that same year.
How did the FDA find out about the problems? Our neighbors to the North. The Canadians halted a trial when they saw what it was doing to patients. In this study, a patient's risk of dying during use of this drug was 50 percent more than two other drugs that were used.
I guess Canada's FDA didn't see the same benefit potential at that point that ours did.
