According to U.S. Food and Drug Administration-acquired marketing data, since late 2010, when the diabetes drug Avandia was removed from the market in Europe because of its cardiovascular risks, approximately 132,000 Americans have been prescribed this dangerous drug, likely resulting in hundreds, or more, serious – and sometimes fatal – adverse reactions, including heart failure and heart attacks.
In September 2010, the FDA and the European Medicines Agency (EMA) reached very different conclusions about the fate of this once top-selling diabetes drug, although both authorities had access to the same safety studies. The EMA concluded that new data support an increased cardiovascular risk associated with Avandia, also known as rosiglitazone. Since they “could not identify additional measures that would reduce the cardiovascular risk,” they “therefore concluded that the benefits of rosiglitazone no longer outweigh its risks and recommended the suspension of the marketing authorization of the medicine.”
The FDA, in contrast, decided in September 2010, after a July 2010 advisory committee meeting, not to ban the drug but instead to institute a risk evaluation and management strategy (REMS) to limit the use of the drug to those they believed could benefit from it. One excuse for not acting more forcefully was that the FDA wanted Avandia’s manufacturer, GlaxoSmithKline, to fund a study to re-evaluate a previous study (called RECORD) on heart risk. The company had been asked by the EMA to do the study shortly after Avandia’s approval by the FDA in 1999. That re-evaluation (re-adjudication) of RECORD was the main topic of a June 6 FDA advisory committee meeting.
The EMA was so appropriately concerned about Avandia’s dangers that it banned the drug, stating that the only way it could ever be marketed again in Europe was if Glaxo could “provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.” It did not waste time with any further evaluation of the RECORD study it had required Glaxo to do.
The reckless FDA conclusion was to eventually institute a REMS (not approved until May 2011 and fully in place until six months later), although there has never been any evidence that those getting the drug were patients for whom its benefits outweighed the risks.
Once again, instead of banning a drug, as recommended by 12 FDA advisory committee members, and as the EMA has done (because the drug has no unique benefits but unique risks), the FDA hides behind a REMS program that has reduced the number of people using the drug in the U.S. to 665 in 2012. Unfortunately, in the interval since the EMA ban, 132,000 people used Avandia in the U.S., likely resulting in hundreds of preventable injuries and deaths. REMS should be reserved for drugs that need to remain available. By no stretch of the imagination is Avandia such a drug. Ask the EMA.
Sidney M. Wolfe, MD, is an expert on issues of drug safety, healthcare policy, Food and Drug Administration and hospital oversight, OSHA, medical devices, Medicare and Medicaid, and doctor discipline. He has appeared on CNBC, CBS, NPR, ABC, NBC, PBS and Fox News, and has been quoted in publications such as The New York Times, The Wall Street Journal, the Associated Press, USA Today, The Los Angeles Times and The Washington Post.