While FDA and Glaxo fiddle over Avandia, patients remain at risk

As a debate over the safety of Avandia has brewed for more than two years, patients still taking the drug have remained guinea pigs for science. This week the New York Times issued a report suggesting Glaxo, the maker of the billion dollar a year diabetes drug knew the drug had significant side effects, but maneuvered to keep the drug on the market. Dr. Steven Nissen, a cardiologist with the Cleveland Clinic, who raised the initial red flag concerning Avandia's cardiac risks, renewed his attack against the drug and its manufacturer, telling The Times that the medical community is still waiting for Glaxo to publish results of a safety study and suggesting the company is trying to whitewash reports of adverse events. HNe criticized the company for failing to publish a followup study, saying the results of Glaxo's Avandia study appear only on the company's web site. To fuel the debate, Nissen gave The Times a secret recording of a 2007 meeting with Glaxo executives. A 2007 study by Nissen found that the risk of cardiac death increased by 64% among patients on Avandia, a finding the company refuses to embrace. Nissen said in an interview that a taped recording of his meeting with Glaxo executives in 2007 showed the excecutives trying to persuade him not to publish his study, suggesting that they had contradictory information they would share with him in a joint study. Nissen said Glaxo did not have any contradictory data. Glaxo executives maintain they visited with Nissen to discuss a possible collaborative study. Meanwhile, the U.S. FDA has failed to take any action to truly protect patients, even after two officials from the FDA issued a report recommending the drug be removed from the market. Glaxo issued a press release refuting the charges in The Times article. When in doubt and when patients health is at stake, shouldn't the U.S. FDA err on the side of overprotection and pull this product, at least temporarily, before more innocent patients are harmed needlessly? If further studies definitively prove Avandia's cardiac safety, then the product can return to market. The FDA needs to adopt a common sense approach to safety in order to prevent any further adverse effects. One death is one too many.