Friday, February 15, 2008
Source:
http://www.reuters.com/article/topNews/idUSN1450916820080215?feedType=RSS&feedName=topNews
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.
The drug Trasylol was withdrawn in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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