Avandia Dispute: Good Or Bad For Consumers?

Since 2005, there has been increasing evidence that the blockbuster diabetes drug, Avandia, increases the risk of cardiovascular problems, such as heart attack, a major cause of death among diabetics. Avandia is still on the market and scientists are battling over its safety. Of course, the drug’s manufacturer, GlaxoSmithKline assures consumers that Avandia is safe and millions of diabetics take Avandia to control blood sugar levels. What is the stance of the Food and Drug Administration on this controversial issue and does the risk-reward ratio justify the continued use of Avandia? Do the cardiovascular risks of Avandia outweight its benefits to consumers?

The Food and Drug Administration does very little to monitor the safety of drugs, such as Avandia, after they are approved by the FDA. Independent researchers are usually the first to reveal potential safety hazards of medications, such as in the case of Merck’s anti-inflammatory drug, Vioxx. On Tuesday, the FDA is scheduled to hold an advisory panel hearing to evaluate the risks and benefits of Avandia. THIS IS ABOUT FIVE YEARS TOO LATE!

Avandia was approved by the FDA in 1999 and became a best seller in short order. Safety concerns were raised by Glaxo in 2005, but those safety concerns were not shared by the FDA with the public. Fortunately, a cardiologist at the Cleveland Clinic, Steven Nissen, did his own investigation and found that consumers had a 43% higher risk of heart attack with Avandia and the New England Journal of Medicine published his analysis. As a follow up to Nissen’s analysis, the FDA required a warning on Avandia’s label.

The FDA is useless at monitoring drugs for safety, as evidenced by the Avandia story. Once the FDA approves a drug, it does nothing to monitor the safety of the drug even though risks emerge as usage of the drug expands. It’s tough to admit that the drug is safe when it is approved and then later admit that the FDA was wrong. The FDA and Glaxo should make available to the public all of the data and investigation materials that they possess relating to Avandia. As stated in today’s USA Today, “Patients shouldn’t have to depend on outside whistle-blowers trolling the internet to learn about potential drug dangers.”