One Thousand Lives A Month

Researcher Estimates 22,000 Lives Could Have Been Saved Had Trasylol Been Pulled Earlier

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Hiatt told 60 Minutes that if he had known about Bayer's study at the first meeting he would have voted to take Trasylol off the market. When he found out what had happened, he wrote an editorial that was published two months later.

"I wrote a perspective piece that disclosed to the American public there were concerns about transparency," he says.

"You describe them as concerns about transparency. Tell me how you felt. You had to be surprised," Pelley asks.

"I'm a scientist. I just review the data," Hiatt says. "How do I feel about this? I don't know."

Asked if he had been angry, Hiatt responds, "I thought it was unusual. I thought it was truly inappropriate."

Last year, the Canadian government conducted a large clinical trial of Trasylol. The study had to be stopped because patients in the study group were dying.

When the study was halted, Germany banned Trasylol, and the Canadians and the FDA persuaded Bayer to suspend marketing temporarily, though surgeons can still use it in special cases. Worldwide, more than four and a half 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.

Mangano says the FDA should have pulled Trasylol after his study two years before.

"How many patients according to your analysis would have been saved if the drug had been taken off the market after your first study?" Pelley asks.

"Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It's about a 1,000 lives saved per month delay in taking that drug off the market," he says.

To the Randones, one life mattered most. In August 2006, Joe Randone died. His family is suing Bayer, which expects to post record profits for this past year, partly on the strength of Trasylol.



Neither Bayer nor the FDA would speak with 60 Minutes for this story. Bayer did send a letter which said, in part, "the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling."

Bayer says it suspended two employees for failing to disclose the results of its 2006 study. But the FDA has taken no action against the drug maker.
Produced By Solly Granatstein