In the view of Consumers Union, news that the popular diabetes drug Avandia—which has been on the market since 1999—may significantly raise patients’ risk of heart attack just emphasizes the need for Congress to pass strong drug-safety laws.
Consumers Union says the recent article and editorial in the New England Journal of Medicine underscores the FDA’s weak post-market safety oversight system, vividly illustrating the need for reforms to more quickly determine which drugs already on the market are not safe.

The NEJM study was conducted by Dr. Steven Nissen of the Cleveland Clinic. It looked at 42 existing trials of people on Avandia (made by GlaxoSmithKline of England) compared with those on other drugs or a placebo. It found that those taking Avandia were 43% more likely to suffer heart attacks. It also found evidence of higher death rates in the Avandia group.

The Avandia case raises other questions about how fully informed the FDA was about patients’ increased risk of heart attack, when it knew of those potential risks and when it would convey them to the public. The FDA issued a safety alert today on the drug after the NEJM analysis was released, saying that GSK’s analysis of its own studies showed a 30–40% greater risk of heart attack.

CU favors laws that will greatly improve the FDA’s post-market safety system and authority. It also calls for all clinical drug trial results be made public so doctors, researchers and patients can more quickly know about about the risks of any a drug.