The president-elect of the American Diabetes Association accused GlaxoSmithKline of "rampant abuse of clinical trial data" in a letter sent to the FDA seven years ago. The letter also spells out John Buse's concerns about cardiovascular deaths and adverse events experienced by patients taking Avandia to control diabetes. A new study in the NEJM has determined from long ignored trial data that Avandia raises the risk of heart attacks by 43 percent and increases the risk of death by a whopping 64 percent.
None of this has gone unnoticed by attorneys, who have begun lining up to take a lineup of new cases that are expected to be filed over this latest scandal over the way the pharma industry has handled safety data. Some lawyers say that the litigation could wind up costing Glaxo tens of billions of dollars.
- here's the report on Avandia from CNN
ALSO: An editorial in The Lancet calls for a calm and considered approach to a new study demonstrating a significantly elevated risk of cardiovascular problems for patients taking the diabetes drug Avandia. Report
Avandia risks exposed under deal to post data. Report