Delay In Drug Recall May Have Caused Thousand of Deaths
Medical researchers interviewed by CBS Television’s 60 Minutes program revealed that an estimated 22,000 patients could have been saved if U.S. regulators acted faster to remove a Bayer AG drug used to curtail bleeding during open-heart surgery.
The drug Trasylol was taken off the market in November 2007 at the request of the FDA after an observational study linked the medicine to kidney failure requiring dialysis and increased death of those patients. Trasylol had been given to as many as a third of all heart bypass patients in the United States at the height of its use over a period of several years, according to the report.
Dr. Dennis Mangano, also tells 60 Minutes correspondent Scott Pelley that Bayer 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. 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.
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 chairman of the FDA advisory panel, Dr. William Hiatt, told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer’s study, according to the CBS report.
Bayer spokeswoman Meredith Fischer said she could not comment about the broadcast until it is aired, including allegations that the drug maker had failed to protect patients.
She said Bayer is facing a number of product-liability lawsuits filed by patients who had taken the medicine or their families, but said she does not know how many lawsuits have filed.
Mangano’s interview will be televised Sunday, Feb. 17, 2008at 7 P.M. ET/PT.