Avandia is in trouble. A key drug for diabetes, one of just two left on the market in its class, it is under increasing scrutiny by the FDA because of concern about its safety and risk for strokes, heart disease, and death. Despite the fact that the mounting evidence against it is based largely on observational studies, where risks are extracted from data that wasn't put together for the purpose of proving a cause and effect, these observations cannot simply be dismissed. Not only that, but concern has now been raised about the 2007 Record trial, which GSK has used to maintain that Avandia is safe. But review of this study by the FDA has discovered instances of people with unexplained medical problems in that study that may have come from Avandia but weren't reported.
Usually when the magnifying glass is applied to a drug company and a product the way it is to GSK and Avandia, this column is the first place to show the other side and point to an overreaction or unfair media attack. Avandia is a great drug in diabetics that improves sensitivity to insulin and helps sugar absorption. It saves lives, but does it also cost lives?
An ongoing prospective study comparing Avandia to Actos, a similar drug in the same class which hasn't been found to have the same risks, is expected to answer the safety question once and for all.
Expect the controversy to be resolved soon—either by restriction or removal. I am not on the manufacturer's side on this one, though I think Avandia is an important treatment that would be tough to lose. Marc Siegel, MD, is an internist and professor of medicine at New York University and the author of False Alarm: The Truth About the Epidemic of Fear