Doctor Claims Quicker Trasylol Removal Could Have Saved 22,000

Reuters is reporting a new look at the results of an old study released on the Bayer AG drug used to stem blood flow during open heart surgery. According to an interview conducted on CBS' 60 Minutes, the drug Trasylol, a drug given to as many as a third of all heart bypass surgery patients over the past several years, was linked to kidney failure and may have accounted for up to 22,000 deaths that could have been preventable.

Dr. Dennis Mangano originally published research on Trasylol in January 2006 suggesting that his research showed links with using Trasylol to kidney failure requiring dialysis. Mangano claims in the 60 Minutes interview that his work was discussed during an FDA advisory panel meeting in September 2006 between Bayer and the FDA, but Bayer failed to disclose to the FDA that their own research on the topic supported Mangano's research.

The chairman of that FDA panel, Dr. William Hiatt, revealed to 60 Minutes that he would have advocated removing the drug from the market if indeed they had been told about Bayer's similar research at the time of the meeting, when the FDA panel concluded that Mangano's research was an aberration that should be considered but should not result in a removal of the drug from the market.

Trasylol was later pulled at the request of the FDA on November 5, 2007, nearly two years after Mangano's study had come out and over a year after the FDA panel initially convened.

Mangano now estimates that, tragically, around 22,000 open-heart surgery patients may have been saved if the drug had been pulled in January 2006, when his research was published.

According to Bayer AG, lawsuits have been filed against the company over deaths associated with use of Trasylol, though there is no concrete number published on the Bayer website or in any news report.

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