This is the story of a drug that was on the market for 14 years and may have contributed to the deaths of thousands of patients. Trasylol, made by Bayer, is given in the operating room to control bleeding. It was a big money maker.
As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.
But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that.
How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month.
Doctors believe one of those patients was Joe Randone. He had a heart murmur since he was born, but that didn't keep him from an active life. On New Year's Eve 2005, Randone seemed to be the picture of health.
Two weeks later, Randone checked himself into a Long Island hospital for heart valve replacement surgery. He was 52, and the surgeon told his wife Josephine and daughter Marissa that the risks were low.
"They said even possibly in five days he would go home. And then, you know, there was a recovery period, as there would be with any kind of heart surgery," Josephine remembers.
"But then he should be in ICU for about 24 hours, and then move up to a regular floor, recuperate and come home," Marissa adds.
Asked if the doctors weren't particularly concerned about this, Josephine says, "No."
"It was routine as far as they were concerned," Marissa tells Pelley.
The surgeon noted the chance of complications at five percent. Trasylol was put in Joe's IV and kept flowing for four hours. At the end of the surgery, the Randones were told that something was wrong.
"They didn't go into specifics," Marissa says. "Just that there were a lot of complications, and that making it through the night was basically our first concern."
Immediately after the surgery, Randone suffered two heart attacks and his kidneys failed. Randone's surgeon wrote in his notes "Aprotinin-induced graft thrombosis." Aprotinin is Trasylol, and thrombosis means blood clotting.
At the same time, in San Francisco, an eminent medical researcher, Dr. Dennis Mangano, was finishing a study that had followed thousands of patients - the largest Trasylol study ever conducted.
Mangano says the study included 5,065 patients in 17 countries.
"It showed an important association between Trasylol use and kidney failure requiring dialysis, Mangano tells Pelley, "And it showed a trend toward increased death in hospital in these patients."
Dr. Mangano was one of the researchers who discovered that aspirin reduces the risk of heart attack. His non-profit institute studies drug safety and how generic drugs can lower health care costs. His work is credited with improving the health of millions. Ten days after Joe Randone's surgery, Mangano's study was published in the New England Journal of Medicine and reported in newspapers across the country, including Long Island.
Marissa says the doctor had just seen an article about the study in the newspaper. "The surgeon told us that he felt that the drug was the reason for all the complications," Marissa says.
"And that he had filed a report with the FDA, and he wanted us to be aware that it was because of this drug," she says.