RESEARCHER ESTIMATES 22,000 LIVES COULD HAVE BEEN SAVED IF THE FDA RECALLED A HEART SURGERY DRUG WHEN HIS STUDY SAID IT WAS HARMFUL TWO YEARS BEFORE ITS MAKER SUSPENDED SALES -- "60 MINUTES" SUNDAY

Another Scientist Says He Warned Bayer That Trasylol Was Harmful in the Early 1980s

A renowned researcher calculates that 22,000 patients could have been saved if the Food and Drug Administration removed the heart surgery drug Trasylol two years ago, when his study revealed widespread death associated with it. The researcher, Dr. Dennis Mangano, also tells Scott Pelley that Bayer, the drug's maker, failed to tell the FDA about negative results of their own Trasylol study and that the company's failure placed the drug's success before patient well-being. Mangano's interview will be broadcast on 60 MINUTES Sunday, Feb. 17 (7:00-8:00 PM, ET/PT) on the CBS Television Network.

Bayer suspended sales of the expensive drug, used to limit bleeding in heart surgery, last year at the request of the FDA, after a Canadian study of Trasylol was stopped because of patient deaths, causing a ban of the drug in Germany, where Bayer is based. At the height of its use, Trasylol was given to about a third of all heart bypass patients in the United States. In Germany, the figure was far higher. 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.

Bayer was also made aware of Trasylol's potential to harm kidneys early in the drug's development, according to a German scientist. Dr. Juergen Fischer, the director of the Institute of Experimental Medicine at the University of Cologne, near the German city where Bayer is headquartered, found the drug caused severe kidney damage in animals. He said he told Bayer about his results in the early 1980s, but, "I felt that Bayer wasn't interested to examine these side effects," he says. "There was no study organized to look at these side effects specially," Fischer says.

The drug has always carried a warning of various side effects, including renal (kidney) effects.

Neither Bayer nor the FDA would speak 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 company plans to assess whether the drug can be remarketed after further research.