22,000 patients dead from Bayer drug Trasylol

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NEW YORK (Reuters) - The lives of 22,000 patients could have been saved if

U.S. regulators had been quicker to remove a Bayer AG drug used to stem bleeding

during open heart surgery, according to a medical researcher interviewed by CBS

Television's 60 Minutes program.

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The drug Trasylol was withdrawn in November at the request of the FDA after an

observational study linked the medicine to kidney failure requiring dialysis and

increased death of those patients.

 

It 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 many years, according to

the report.

 

Dr. Dennis Mangano, the study's researcher, said during the program that

22,000 lives could have been saved if Trasylol had been taken off the market

when he first published his study in January 2006, according to a CBS News

report on its Web site ahead of a broadcast slated for next Sunday.

 

He said in the broadcast that Bayer failed to disclose to the FDA during an

FDA advisory panel meeting in September 2006 -- at which Mangano's negative

findings were discussed -- that the German drugmaker had conducted its own

research which confirmed the same dangers established by his study.

 

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 drugmaker 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 not know how

many lawsuits were filed.

 

(Reporting by Ransdell Pierson; Editing by Gary Hill)

 

 

 

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