The Trasylol Controversy Continued
If you have not read the most recent blogs of the Injury Law Report on this subject, here’s a brief summary:
Trasylol is a drug used to control bleeding and limit the need for blood transfusions in patients undergoing Coronary Artery Bypass Grafting (CABG) surgery. Trasylol is administered intravenously after a patient is under anesthesia and not aware of receiving this drug. Several studies have linked Trasylol to a nearly doubling of the risk of kidney failure resulting in the need for dialysis. In September 2006, Dr. Dennis Mangano presented a study on the drug to the FDA concluding that Trasylol increased the risk of kidney failure, and the risk of death by about 50 percent for some patients. Bayer complained, and the FDA permitted the drug to remain on the market. While this was not the first study linking Trasylol to adverse consequences, it was one of the first that clearly gave the FDA significant data that Trasylol posed an unacceptable risk to patients.
Last year, the Canadian government produced a study that neither the FDA or Bayer could ignore. The Ottawa Health Institute conducted a large clinical trial of Trasylol. The study, however, had to be stopped prior to completion because patients in the study group were dying. In late October 2007, FDA was notified that researchers at the Institute stopped the study because Trasylol appeared to increase the risk for death compared to two other “antifibrinolytic” drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding.
When the study was halted, Germany banned Trasylol, and the Canadians and the FDA persuaded Bayer to suspend marketing temporarily in November 2007 (though surgeons can still use it in special cases). Worldwide, more than 4.5 million people had been given the drug. About a third of them were Americans who received it during the 14 years that it was on the U.S. market.
Dr. Mangano claims that the FDA should have pulled the drug off of the market months earlier because the data supporting kidney failure and death in many patients was clear. He calculates that FDA’s delay in pulling the drug from the market may have resulted in 22,000 preventable deaths.
How did this drug remain on the market? First, Bayer pushed the drug hard. By 2005, sales of the drug hit $300 million. The next year, $750 million was projected. The makings of a billion-dollar drug? Yes, that’s what Bayer believed, and that kind of money can make potential problems with the drug seem minor. Also, the FDA did not act decisively when it should have done so. Despite the potential risks to patients, the FDA even expanded its approval of the drug in 1998 to cover all heart bypass patients.
The Trasylol controversy and one man’s fight for survival recently was featured on national television. More on this in our next blog.#