The FDA yanked the heart surgery drug Trasylol off the market last November, but a medical researcher now claims that 22,000 lives could have been saved if Bayer AG hadn’t withheld the results of an earlier internal study proving the drug’s danger. An FDA committee held hearings in September 2006 to determine Trasylol’s safety, but three of the committee members had a financial interest in Bayer, and the drug maker had underwritten the committee chairman’s research.

[Drug researcher Dr. Dennis Mangano] believes Trasylol should have been taken off the market when he published his study in January 2006, a study that associated the drug’s use with kidney failure requiring dialysis and increased death of those patients. Between the study’s publication and November 2007, when Bayer removed the drug, “There were approximately 431,000 patients who received the drug,” says Mangano. “As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month,” he tells Pelley.

In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade them to pull the drug. Bayer senior executives attended the meeting to defend their product and at the time, their company had results from its own research that confirmed Mangano’s results. But the Bayer executives failed to disclose the existence of the study. Mangano says this was irresponsible. “The [Bayer] representatives at the meeting…should have disclosed fully to the FDA that a study was done…even put the meeting in abeyance until the data were found or discussed,” Mangano tells Pelley. “Good medicine demands that you protect the patient. That’s the issue here and not the drug and not the profit margin,” he says.

The chairman of the FDA committee that held that meeting, Dr. William Hiatt, told 60 Minutes that he would have voted to remove Trasylol from the market if he had known about Bayer’s study. He also took issue with Bayer’s failure to disclose it. “I thought it was unusual. I thought it was truly inappropriate,” he tells Pelley.

Dr. Hiatt, who wrote three papers underwritten by Bayer, may be sorry now, but he had no problem skewering Dr. Mangano’s research at the time. The full story complete with scary graphics and ominous music will air tonight on 60 minutes.

22,000 died amid delayed Bayer drug recall: doctor [Reuters]
(AP Photo/Roberto Pfeil)

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