In the initial studies that assessed the risk of the drug experts, including Nissen and even FDA scientists say the company sponsored studies were flawed and minimized the heart risks. Dr. Allison Goldfine, head of the section on clinical research at Joslin Diabetes Center and a member of the panel that voted to keep Avandia on the market said, There were a lot of questions raised about how to interpret the data, and there was a tremendous amount of uncertainty.
Sales of the medication began dropping after Nissen's paper was published and the FDA issued its first warning, advising patients with a history of heart disease from taking the drug. Says Nissen, I find it hard to imagine that even a single patient can't take any of the other diabetes drugs. Nobody should essentially get this drug.
Dr. Ellen Strahlman, of GSK said, Our primary continues to be patients with type 2 diabetes and we are making every effort to ensure that physicians in Europe and the US have all the information they need to help them understand how these regulatory decisions affect them and their patients.