The Cochran Firm Legal Blog

A little more than a week after the announcement of a Harvard University study on the risks of Avandia, The New York
Times is reporting that the FDA plans to consider removing the popular but potentially deadly diabetes drug from the market. The Times cites confidential reports by a number of doctors that recommend the drug be removed from the market, reports that say as many as 300 heart failures a month could be prevented by switching people to a different diabetes drug, Actos. One report definitively recommends that "Rosiglitazone [the active ingredient in Avandia] should be removed from the market." The reports stress that the drug offers no real benefits for the increased risk, making it an unnecessarily dangerous drug.

However, the agency is not in complete agreement. Apparently, there is an internal battle in the agency over the safety of Avandia, despite the mounting evidence of Avandia's heart attack risk. To resolve the dispute, FDA scientists have scheduled a meeting for later this year to make recommendations about the drug.

Pressure may be mounting for the agency to do something. Yesterday, the US Senate issued the results of its two-year investigation into the conduct of GlaxoSmithKline (GSK), the drug company that manufactures and markets Avandia. The damning report says that GSK tried to intimidate scientists and deliberately misrepresent medical data to protect the profitability of the blockbuster drug, whose worldwide sales peaked at $3.2 billion in 2006. Concurrently, the FDA issued its own statement, stressing that guidelines for the drug's use have not changed and that people should not stop taking Avandia without first talking to their doctors.

GSK denies that it has ever tried to intimidate scientists, saying instead that it "welcomes and supports open and independent scientific debate about its products," and adds that 164 independent clinical trials have failed to find an association between Avandia and heart attacks. However, as new studies continue to pile up, they all seem to point to one conclusion: Avandia increases the risk of heart attacks, something the US Senate says GSK knew and tried to suppress.

If you have been injured by a pharmaceutical drug like Avandia, you are facing a tough battle against a multibillion-dollar, multinational corporation like GlaxoSmithKline. You can improve your odds of success by working with a nationwide network of lawyers that has significant resources and experience with pharmaceutical injury lawsuits. The Cochran Firm is such a law firm, and we are dedicated to fighting for you. For a free case evaluation, please call or email us today.