In May 2007, an article published in the New England Journal of Medicine raised serious questions about the safety of Avandia. The article reported the results of statistical analysis of adverse cardiovascular effects of this drug by the renowned heart scientist, Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic.  According to the article, Avandia caused a 43% increase in heart attack (myocardial infarction) and a 64% increase in cardiovascular-related death in patients taking the drug. 

Dr. Nissen’s conclusions were based on a “meta” analysis, i.e., a statistical analysis which combined data from all relevant clinical trials of Avandia completed to date. Information from 42 clinical trials of Avandia was used in Dr. Nissen’s statistical analysis. Based on the requirements of the FDA and the regulatory agencies in the Europe, GSK had performed a number of pre- and post-marketing of clinical and observational trials on Avandia. However, only the results of two major GSK-sponsored pre-marketing clinical trials were published by GSK. GSK neither published, nor reported to the FDA the results of many of the post-marketing trials of the drug. 

GSK Knew of the Problems.

Evidence shows that GSK was aware of this problem all along. As early as 1999, Dr. John Buse, a professor of medicine at the University of North Carolina and the 2007-2008 President of the American Diabetes Association suggested that Avandia may cause increased cardiovascular risks. His conclusion was based on the evidence that the drug had negative effects on fats in the blood and on the emergence of signals that it increased the risk of heart attack.