Avandia Debacle Prompts FDA to Consider New Rules for Approving Diabetes DrugsJun 30, 2008 | Parker Waichman LLP Federal regulators are mulling over new rules for approving diabetes drugs. The new regulations the Food & Drug Administration (FDA) is considering include requiring that new diabetes drugs have a positive impact on cardiovascular disease and life span. The push for new rules comes a little over a year after a study found that Avandia - a popular diabetes drug marketed by GlaxoSmithKline - raised cardiovascular risks and probably did little to improve the life span of the people taking it.
Avandia has been a subject of controversy since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In June 2007, Congress held hearings to discuss the FDA's handling of its safety issues. At those hearings, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. Thus, the public was not made aware of the Avandia heart attack risk until the publication of the Cleveland Clinic article.
Currently, the FDA requires the makers of diabetes drugs to prove they lower blood sugar levels. This outcome is known as a surrogate endpoint, because it was thought that lowering blood sugar would have a positive effect on cardiac risks and life span - the true goals of a diabetes drug. But the Avandia debacle has led many experts to call on the agency to require drug makers to meet other bench marks, including whether they reduce the risk of cardiovascular problems - the number one killer of diabetics.
The issue of what benchmarks the FDA should use to approve diabetes drugs will be the topic of a special two-day meeting of FDA officials and outside medical experts set to start Tuesday. The FDA will also consider if the makers of diabetes drugs currently on the market, including Glaxo, should conduct additional studies on whether there are long-term cardiac risks with their products. According to The Wall Street Journal, scheduled speakers at the meetings include several doctors who have questioned the validity of surrogate end points. One, cardiologist Steven Nissen of the Cleveland Clinic, authored a 2007 Avandia study.
The practice of allowing surrogate endpoints to approve new drugs was also questioned this year when Vytorin, a blockbuster cholesterol lowering medication, was found to be ineffective in preventing clogged arteries. Vytorin had been approved on the basis that it lowered bad cholesterol. It was thought that would correlate to a decrease in the amount of arterial plaque in patients taking the drug. But a study released in January showed that assumption to be wrong.