• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Download full size image

22,000 Deaths From Delayed Recall of Heart Drug

Posted on: Friday, 15 February 2008, 13:35 CST

An estimated 22,000 lives could have been saved if the Food & Drug Administration (FDA) removed the drug Trasylol from the market two years ago when evidence emerged implicating the drug in thousands of deaths, according to a respected researcher interviewed for an upcoming CBS 60 Minutes broadcast.

Trasylol, made by Bayer, is used to limit bleeding in heart surgery. At the height of its use, it was given to about a third of all heart bypass patients in the United States. The drug has always carried a warning of various side effects, including renal (kidney) effects.

The researcher, Dr. Dennis Mangano, told 60 Minutes correspondent Scott Pelley that Bayer also neglected to report to the FDA negative results of the company’s own internal study of the drug’s safety, and that this failure placed the drug's success above patient health.

At the FDA’s request, the company suspended sales of Trasylol last year after a Canadian study of Trasylol was halted due to patient deaths. The study led health authorities in Germany, where Bayer is based, to ban all sales of the drug.

According to a CBS News report on its Web site ahead of next Sunday’s broadcast, Mangano said Trasylol should have been taken off the market when he published his study in January 2006. The study associated use of the drug with kidney failure requiring dialysis and increased death of those patients.

In September 2006, Mangano presented his observational study of 5,065 patients in 17 countries to the FDA in hopes it would persuade the agency to pull the drug. Bayer senior executives attended the meeting to defend their product and had results from its own research confirming Mangano’s results. However the executives failed to disclose the existence of their own internal company study.

Mangano called this 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 told Pelley. "Good medicine demands that you protect the patient. That’s the issue here and not the drug and not the profit margin," he said.

Between the study’s publication and November 2007 when Bayer removed the drug from the market, "There were approximately 431,000 patients who received the drug," Mangano said. "As I calculated, 22,000 lives could have been saved. It’s about a 1,000 lives per month," he told Pelley.

Dr. William Hiatt, chairman of the FDA committee that held that meeting, told 60 Minutes that he would have voted to remove Trasylol from the market if he had known about Bayer’s study. He also objected to Bayer's failure to disclose it. "I thought it was unusual. I thought it was truly inappropriate," he told Pelley.

According to Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, near the German city where Bayer is headquartered, Bayer was made aware of Trasylol's potential to harm kidneys early in the drug's development. Dr. Fischer’s research found that 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 said. “There was no study organized to look at these side effects specially.”

Neither Bayer nor the FDA would speak to 60 Minutes for their story. According to the CBS report, 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 determine whether the drug can be remarketed after further research.

In a report by Reuters, Bayer spokeswoman Meredith Fischer said she could not comment about the broadcast until it aired, or about allegations that the company 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 was not aware of the number of lawsuits that were filed.

The CBS 60 Minutes interview will air this Sunday, Feb. 17, at 7 p.m. ET/PT.

---

www.fda.gov

www.bayer.com

Source: redOrbit staff

More News in this Category