Dr. Dennis Mangano Says On 60 Minutes In February 2008 That Trasylol Should Have Been Recalled As Early As January 2006
Delay By Bayer And FDA Until November 2007, When Trasylol Sales Were "Suspended", Caused 22,000 Excess Deaths Per CBS Report
(Posted by Tom Lamb at DrugInjuryWatch.com)
According to interviews broadcast by CBS Television's 60 Minutes program about Trasylol on February 17, 2008, an estimated 22,000 patient lives could have been saved if the FDA had acted quicker to recall Trasylol, Bayer AG's drug used to stem bleeding during open heart surgery.
Trasylol (aprotinin injection) sales in the U.S. and Canada were suspended by Bayer in early November 2007. Trasylol was used to reduce blood loss during coronary artery bypass surgery.
As background, in mid-February 2006 the FDA announced it was evaluating the safety of Trasylol after new studies had linked this heart surgery drug to higher risks of kidney problems, heart attacks, and strokes. At the end of February 2006 a "Dear Doctor" letter from Bayer regarding Trasylol was posted on Health Canada's MedEffect web site.
Later, the FDA held an advisory committee meeting in September 2006 and, thereafter, convened another such meeting on September 12, 2007 to further discuss Trasylol.
A February 15, 2008 Reuters article, "22,000 died amid delayed Bayer drug recall: doctor", provided these details based on a review of this 60 Minutes report about Trasylol that had been posted on the CBS News web site in advance of the February 17 broadcast:
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....
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.
As acknowledged by company spokeswoman Meredith Fischer in the February 15 Reuters article, product liability lawsuits have been filed against Bayer on behalf of patients who had died or been seriously injured following the use of Trasylol during their heart surgery.
P.S. In advance of the September 2006 advisory committee meeting about Trasylol, FDA reviewers asked Dr. Mangano for his group’s data in order to see if Trasylol should be withdrawn based on the new evidence. Read what happened thereafter in Merrill Goozner's November 27, 2006 article, "CABG from NEJM on Thanksgiving", which he posted at Gooznews.com (2/19/08)
