Personal Injury Law

Diabetes Drug Avandia Blamed For Heart Problems

By Mark Siesel, Esq.

In a front page story in the February 20, 2010 edition of the New York Times, Gardiner Harris reported on confidential FDA reports which have recommended that the diabetes drug Avandia be removed from the market. Apparently, FDA studies have determined that if diabetes sufferers had taken another drug, Actos, approximately 500 heart attacks and 300 cases of heart failure could have been avoided. Avandia, also known by its clinical name Rosiglitazone, is prescribed to patients with Type 2 diabetes. This apparently dangerous drug was linked to a shocking 304 deaths worldwide in the third quarter of 2009, according to a study by the Institute for Safe Medication Practice, a drug safety group

Two FDA researchers, Dr. David Graham and Dr. Kate Gelperin, concluded that "Rosiglitazone should be removed from the market." There is a significant conflict over what should be done with Avandia. Naturally, the manufacturer, GlaxoSmithKline, is claiming that the reports of cardiac problems as a result of Avandia use are not scientifically definitive and require further study. Senators Charles Grassley, an Iowa Republican, and Max Baucus, a Montana Democrat, who have overseen the FDA study, are sharply critical of GlaxoSmithKline, stating that the company should have alerted patients many years ago of the potential cardiovascular risks of Avandia, thus offering patients the opportunity to take a less dangerous drug for their diabetes. But as early as 2003, according to the Senate investigation, GlaxoSmithKline and the FDA were aware of a GlaxoSmithKline study in which diabetics who used Avandia had substantially more heart problems than those given placebos!

Several years back, Avandia was one of the top selling drugs in the world, but after a 2007 study by a Cleveland Clinic cardiologist suggested cardiac risks from Avandia, the FDA got involved, and sales of the drug took a dive. Mr. Harris also reports that GlaxoSmithKline executives attempted intimidation tactics to prevent independent physicians from notifying patients or other doctors that Avandia posed serious heart risks to diabetics, who die from heart problems 66% of the time. In one egregious example, in 1999, University of North Carolina professor John Buse gave presentations at scientific meetings suggesting that Avandia caused heart problems. As a result, GlaxoSmithKline executives complained to his supervisor and warned of potential legal action against Dr. Buse in an effort to keep him quiet. Dr. Buse ended up signing a document prepared by GlaxoSmithKline agreeing not to publicly discuss his concerns about Avandia. The report mentions another similar incident of intimidation of University of Pennsylvania investigators.

Full post as published by New York Legal Blog on February 22, 2010 (boomark / email).