The lives of 22,000 people could have been saved if the FDA removed Bayer's Trasylol two years ago, when his study revealed a growing number of deaths linked to the heart drug. That's whatDennis Mangano, founder of the non-profit Ischemia Research and Educational Foundation, tells 60 Minutes in an interview to be broadcast this weekend, according to CBS News.
Mangano, whose January 2006 study in The New England Journal of Medicine showed Trasylol put patients at higher risk of heart attacks, stroke and renal failure, repeats allegations that Bayer failed to tell the FDA about negative results of their own study. Despite his study, an FDA panel declared Trasylol, a drug used to reduce bleeding during bypass procedures, was safe and effective, and voted unanimously to keep the med on the market. (Mangano is pictured to the right).
But the FDA was later contacted by a Harvard researcher, who was hired by Bayer to review a huge database of bypass patients, and he charged Bayer with hiding evidence. His analysis matched Mangano’s, and Bayer said it “mistakenly” neglected to mention the giant study and denied a cover-up. More recently, though, Bayer suspended sales after a Canadian study was stopped because of patient deaths. At one time, Trasylol was given to about a third of all heart US bypass patients.
The chairman of the FDA committee that held that meeting, William Hiatt, tells 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 says.
Bayer was also made aware of Trasylol's potential to harm kidneys early in the drug's development, according to Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, near the German city where Bayer is headquartered. He found the drug caused severe kidney damage in animals and told Bayer about his results in the early 1980s, but "I felt that Bayer wasn't interested to examine these side effects," he tells 60 Minutes. "There was no study organized to look at these side effects specially." Trasylol always listed a warning about renal side effects.
Between publication of his own study and November 2007, when Bayer removed Trayslol, "There were approximately 431,000 patients who received the drug," Mangano tells 60 Minutes. "As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month..."The (Bayer) employees at the (FDA) 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. 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 FDA wouldn't comment to 60 Minutes for this story. Bayer sent a letter stating, in part: "The available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling." The drugmaker plans to assess whether the drug can be remarketed after further research.