Avandia Debate Continues at ADA Conference

Orlando, FLThree years after Dr. Steven Nissen pronounced a so-called death sentence on type 2 diabetes drug Avandia, there is still confusion as to just how bad the drug is. Discussions and presentations at a recent gathering of the American Diabetes Association (ADA) reveal that medical opinion remains polarized.

According to a 7/4/10 summary of events at the ADA gathering by ABC News, Dr. Joel Zonszein of Montefiore Medical Center expressed the view that Avandia and other drugs in the thiazolidinedione class should remain "available for use at the physician's discretion," he said. "Avandia is already rarely prescribed."

Three years of negative press and controversy have driven that point home for most people. But even though Avandia is not the blockbuster drug it once was, IMS Health data show that the drug was prescribed to 2.6 million Americans last year. It remains a billion-dollar seller for manufacturer GlaxoSmithKline, according to ABC.

Dr. Steven Nissen, the Cleveland cardiologist who first blew the whistle on Avandia in 2007, told the ADA gathering that Avandia is linked to a 28 to 39 percent relative risk for heart attacks in patients taking Avandia. Nissen's updated numbers, published online in the Archives of Internal Medicine, were based on a meta-analysis of 56 previously published studies.

The ADA is not prepared to take an official stance. Neither is the American College of Cardiology or the American Heart Association, according to ABC. It seems they prefer to wait for the US Food and Drug Administration (FDA) make the ruling on whether Avandia stays or goes. The drug watchdog is slated to conduct an in-depth consultation with an expert panel with regard to Avandia later this month.

Actos, a rival type 2 diabetes drug manufactured by Takeda, has often been portrayed as a safer alternative to Avandia. However, there were those at the ADA meeting who argued that thiazolidinediones should not be prescribed at all—Actos among them.

"Why would we use a drug that might be harmful, even though it's not conclusive when there are so many other choices?" said Dr. David Nathan of Massachusetts General Hospital in Boston.

"The first question is not whether to switch someone from Avandia to Actos, but whether they should be on either one at all," said Dr. Lee Green of the University of Michigan in Ann Arbor.

Yet there are those who feel that Avandia (and Actos) are effective in controlling blood sugar in high-risk type 2 patients who are generally obese and suffer from a more aggressive form of diabetes. For these patients, diabetes becomes an issue at an earlier age and can trigger liver disease, even liver failure, according to Zonszein.

Dr. Robert Eckel, a former head of the American Heart Association, noted that Avandia and Actos are effective in fighting fatty liver disease—although he notes that this is not an FDA-approved indication. While many doctors have switched their patients away from Avandia over the last three years, Eckel said he continues to treat Avandia patients with Avandia if they came to him already taking the drug.

Avandia carries a black box warning for risk of heart failure. The package insert warns about swelling, fracture, weight gain after four years and anemia.