One Thousand Lives A Month

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

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Feb. 17, 2008

(CBS)  What the surgeon likely didn't know was that there had been concern about the drug as far back as the early 1980's. It was then, in Bayer's hometown, that Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, found severe kidney damage in animals given Trasylol. He told Bayer, but he was surprised by the drug company's reaction.

"I felt that Bayer wasn’t interested to examine these side effects," Fischer says.

Soon, the same side effects were being seen in humans in America.

"The most common problem we saw was renal failure. That is, that kidneys did not function properly after surgery," says the Missouri Baptist Medical Center's Dr. Nicholas Kouchoukos, one of this country’s top heart surgeons.

In 1992, he conducted a small study, not funded by Bayer, in which Trasylol was given to 20 patients.

"Thirteen of these patients had problems with kidney function after the procedure," Kouchoukos says.

"What did you think?" Pelley asks.

"Well, this was the red flag. And it appeared that it was related to the use of Trasylol," he says.

The red flags showed up in some studies, but not others. Safety concerns are often hard to assess until thousands of patients have received a drug. And critics maintain that Bayer never paid for any studies that were large enough to determining whether kidney failure was a problem. All the research did show Trasylol controlled bleeding, so in 1993, the FDA approved it.

"Doesn't a drug have to be proven safe before the FDA allows it on the market?" Pelley asks Mangano.

"No," he replies. "The trials that are constructed before a drug is marketed and given approval to be marketed generally address effectiveness of the studies."

"Make sure I understand. If the FDA is not certifying a drug as safe, before it goes on the market, what is it doing?" Pelley asks.

"It's certifying that the drug is effective and that within the small numbers studied, relatively small, it doesn't appear to be unsafe," Mangano says.

The FDA approved Trasylol for patients at high risk of bleeding and it noted kidney toxicity was a problem. Bayer pushed the drug hard. In 1998, the FDA expanded its approval to cover all heart bypass patients. By 2005, sales of the drug hit $300 million. The next year, $750 million was projected, and Bayer envisioned a billion-dollar drug.

Then came the Mangano study in 2006 that suggested thousands of patients had died. The FDA issued an advisory to doctors alerting them to Mangano's study. But the FDA didn't plan to have a meeting about Trasylol for eight months.

Bayer wanted to have its own study for that meeting to compare with Mangano's, so the company hired Harvard professor Dr. Alexander Walker to look at the records of nearly 70,000 patients. Walker's results were the much the same as Mangano's. Patients on Trasylol, he wrote, had an elevated risk of death and acute renal (kidney) failure.

Meanwhile on Long Island, winter turned to spring, and Joe Randone grew worse.

"It was a domino effect. Once the kidneys stopped working, then it affected other organs. He was so swollen that he couldn't even close his eyes," Josephine remembers.

Produced By Solly Granatstein
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