Avandia, Diabetes and the Risk of Heart Attacks - February 22, 2010

The U.S. Senate released a report on Saturday which links the diabetes drug to thousands of heart attacks. The report asserted that pharmaceutical maker GlaxoSmithKline knew of the possible heart attack links several years before evidence of those links became publicly known. The report is the result of a two year investigation and maintains that the GlaxoSmithKline executive "attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk." Avandia was GlaxoSmithKline's third best selling drug in 2006, accounting for revenues of 2.2 billion dollars. That revenue had been reduced to 1.2 billion at the end of 2008 because of safety concerns.

According to a May, 2007 analysis of 42 clinical trials, patients taking Avandia had a 43 percent higher risk of having a heart attack. The analysis was published by the Cleveland Clinic. According to an October 2008 internal FDA memo reported by a New York Times report, Dr. David Graham and Dr. Kate Gelperin recommended that Avandia be removed from the market. According to that memo 500 heart attacks and 300 cases of heart failure per month were avoidable if patients took the drug Actos instead. Because Avandia is used in the treatment of diabetes, the report caused concern because two-thirds of the people with the most common form of diabetes (type 2), die from heart problems.

According to the Senate's report, the FDA's own scientists estimated that Avandia was responsible for more than 80,000 heart attacks between 1999 and 2007, and that some could have been avoided had GlaxoSmithKline considered the drugs cardiovascular risks when they were first raised in 1999. There is apparently sharp disagreements in the FDA over how to deal with Avandia's risks. FDA spokesman George Strait said that the agency is reviewing new data on the drug and will be presenting those findings to an advisory committee sometime this summer.