$3 Billion in Shame for Glaxo Smith Kline today, But even more Blame should go to the FDA

Glaxo  is the most recent drug maker to face hefty penalties for improper drug marketing activities.  As reported today,   Glaxo (GSK) agreed to plead guilty and pay $3 billion to resolve allegations that it illegally promoted prescription medicines and failed to report safety data.  The settlement is the largest-ever awarded in a health-care fraud case in the US.

Federal prosecutors said GSK will plead guilty to marketing the drugs Paxil and Wellbutrin for uses not approved by the U.S. Food and Drug Administration and for failing to report clinical data on Avandia.   (More on the evils of Avandia below)

GSK  Marketing Schemes and Sales Tactics

You’d be sickened if you watched some of the videos on the evening news* showing how GSK rolled out one of their drugs in a release to its sales force that looked more like the opening of a Madonna concert. Also as video footage revealed, one  of their high ranking employees was shown pumping up its sales force by saying “who wants to be a millionaire?”

Whistleblower claims state that a  GSK case started back in 2003 with claims by multiple Glaxo sales reps that they were being told to press doctors to prescribe drugs for unapproved uses, including uses involving young children. The drugmaker also was accused of not disclosing dangers of diabetes drug Avandia, and of overcharging Medicaid for drugs.

Avandia has had a bad track record going back years, but why did the FDA ignore it?

The FDA’s own research originally showed Avandia to be associated with a significant increase in heart attack risk, yet the FDA did nothing to protect the public. The agency’s own scientists wrote in 2008, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure.” This evidence went completely ignored at the FDA.

More dangerous public safety evidence ignored:
Here’s what the American Medical Association wrote in 2007 in its journal, JAMA: “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.”

The New England Journal of Medicine also warned about the safety of the drug in an article published in 2007.

Despite these multiple warnings, an FDA panel voted 22 – 1 in favor of keeping Avandia on the market.  So who really  should be in shame and who should be to blame? This,of course,is the real multi-billion dollar question.

*Take a few minutes to watch this video:

http://www.cbsnews.com/video/watch/?id=7413628n

Other References:
http://www.naturalnews.com/028233_GlaxoSmithKline_Avandia.html#ixzz1zW0Ct3f5

http://abcnews.go.com/Blotter/pharma-giant-gsk-pay-3b-illegally-marketing-drugs/t/story?id=16695205

David P Dansereau,MSPT

Missed this one? Read my last post how the FDA’s poor track record has also failed stroke patients

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