60 Minutes Zero's in on Bayer & The FDA
Feb/18/2008 05:53 Filed in: Media
(TV)
60 Minutes continues to be one of the top rated shows on TV and draws a huge highly educated and affluent audience. The last thing anyone working for pharma would have want to have seen was this report which was put into human context with a story of an otherwise healthy 52 year old man who went in for routine heart valve surgery and wound up having a series of operations until he died because of Trasylol. According to the report:
As correspondent Scott Pelley reports, Bayer marketed Trasylol aggressively until it was used in about one third of all cardiac bypass operations in America.
But then, in 2006, a study showed widespread death associated with Trasylol, and as it turns out there was concern long before that. How much did Bayer know? And why did it take Bayer and the U.S. Food and Drug Administration nearly two years to take the drug off the market after major studies revealed the danger? Two years - during which it's estimated Trasylol was contributing to the loss of one thousand lives a month.
To make matters worse Bayer funded a clinical study that clearly showed that this drug was dangerous and did not present it to the FDA during a hearing because "they did not have a chance to review the data". When one of the reviewers was told about Bayer holding back the data all he could do was laugh when the correspondent asked him "aren't you angry "?
At the end of this report all I could do was shake my head. This is more then irresponsible it is criminal behavior that may have cost a lot of lives. Rather then investigate if Dr Jarvik is a credible spokesperson for Lipitor Congress should call people from Bayer into Congress and charge them with criminally negligent homicide if it is shown that Bayer held the data so they could continue to make a lot of money. This is also a prime example of what is wrong with pharma today and why it's time for wholesale change within the industry.
|