Avandia, Type 2 Diabetes mellitus, heart damage and the toothless FDAThis week, two very unpleasant reports have been published detailing Glaxo-Smith-Kline's abuse of Type 2 diabetics and the drug licensing system. Both reports apparently confirm that GSK's Avandia, or rosiglitazone, is unsafe, causes an unreasonable number of cardiac deaths, and should be withdrawn from the market. Two physicians at the FDA, Dr. David Graham and Dr. Kate Gelperin, are quoted by the New York Times as recommending, without success, that Avandia be withdrawn from the market. Reportedly, the drug was linked to 304 deaths in the third-quarter of 2009, alone, and results in 500 heart attacks and 300 cases of heart failure every month!
Avandia has been aggressively marketed by GSK and sales of the drug were $3.2 billion dollars in 2006, despite the fact that GSK was warned as early as 2003 that the drug presented unreasonable cardiac risks to diabetics. In November of that year, the company completed a study showing a significant increase in cardiac problems when compared to placebo patients. In January of 2004, the World Health Organization sent GSK an alert that "linked Avandia to heart ailments." By June of 2004, the company's Global Safety Board had determined that more research was needed because of this problem and European regulators had ordered GSK to conduct further research on cardiac risks that it had identified with the drug.
GSK then performed a meta-analysis of its Avandia research and confirmed a 33 percent increase in cardiac problems associated with Avandia, however, it did not share this data with the FDA until 2006. At that point, the company simultaneously began negotiations with the FDA about a proper response to these concerns, while continuing to market the drug aggressively. It had already threatened litigation against Dr. John Buse and the University of North Carolina as a result of Buse's presentations at scientific meetings warning of Avandia cardiac risks. It also intimidated researchers at the University of Pennsylvania, apparently, as its DMT2 market share swelled in response to aggressive marketing.
Finally, in 2007, a single cardiologist at the Cleveland Clinic had the courage to make his safety concerns public, stimulating much-belated action by the FDA, which finally issued a consumer warning. Sales plummeted, however hundreds of thousands of patients continue to take the medication today, and, obviously, hundreds continue to die each month, unnecessarily. Nevertheless, the FDA has refused to remove the drug from the market--probably because of a combination of drug manufacturer influence over FDA oversight boards, and reluctance of "independent" regulators to admit a previous error. At the most recent review, the FDA board voted 8-7 against taking Avandia off the market, despite the fact that apparently type 2 diabetics could achieve the same benefit by taking Actos, without assuming the corresponding risks of Avandia.
It is this kind of product and FDA failure---and crass manufacturer profit-taking---that explains why Michigan (alone among all the states) made a mistake during "tort reform" by granting product immunity to the manufacturer of any drug approved by the FDA.