Snappy newsletters. Simple Facebook sharing. Spirited comments. Sweet features are waiting… GET THEM NOW!

FDA Delay Cost 22,000 Lives: Doctor

Agency took a year to pull lethal heart surgery drug Trasylol

By Jane Yager,  Newser Staff

Posted Feb 15, 2008 7:53 AM CST

(Newser) – A prominent researcher who revealed widespread fatalities associated with the heart surgery drug Trasylol says 22,000 people died because of the FDA's delay in blowing the whistle on the drug after his study was published. Drugmaker Bayer also failed to disclose negative results of its own study. In a 60 Minutes interview to air Sunday, Dr. Dennis Mangano says the FDA waited more than a year to pull Trasylol—until after it was banned in Germany.

Mangano's study associated the drug, used to limit bleeding in heart surgery, with kidney failure. In September 2006, when Mangano presented his study to the FDA, Bayer defended the product. and failed to disclose the company's own earlier research, which confirmed Mangano's results. The FDA finally halted sales of Trasylol in November 2007.

The logo of pharmaceutical giant Bayer, manufacturer of Trasylol
The logo of pharmaceutical giant Bayer, manufacturer of Trasylol   (Getty Images)
CEO of German pharmaceutical giant Bayer Werner Wenning addresses a third-quarter results press conference in Leverkusen 06 November 2007. German chemicals and pharmaceutical group Bayer posted a third quarter net profit that was almost four times bigger than a year earlier owing to strong pharmaceutical results and a one-off tax...
CEO of German pharmaceutical giant Bayer Werner Wenning addresses a third-quarter results press conference in Leverkusen 06 November 2007. German chemicals and pharmaceutical group Bayer posted a third...   (Getty Images)
A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global marketing of its anti bleeding drug Trasylol after a Canadian clinical study...
A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global...   (Associated Press)
A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global marketing of its anti bleeding drug Trasylol after a Canadian clinical study...
A bottle of the drug Trasylol by German pharma company Bayer is seen in a hospital in Dusseldorf, western Germany, Feb. 7, 2007. Drug maker Bayer AG said Monday, Nov. 5, 2007, that it has halted the global...   (Associated Press)
« Prev« Prev | Next »Next » Slideshow
To report an error on this story, notify our editors.
A snapshot of the day's best news stories.
 
COMMENTS
Be the first to comment on this story.

More Newser Stories

Sales of Heart-Surgery Drug Halted

FDA Takes Over 3 Tylenol Plants

US Prescription Drugs Tested on World's Poor

Avandia Woes Mount Ahead of FDA Hearing

Anti-Smoking Chantix, Zyban Pose Suicide Risk: FDA


NEWS FROM OUR PARTNERS
Other Sites We Like:   24/7 Wall St.   |   Betty Confidential   |   BuzzFeed   |   Cracked   |   Fark   |   Timelines   |   The Frisky   |   Geek Sugar   |   NewsOne