Three years ago, in one of the more notable drug-safety scandals in recent history, the diabetes drug Avandia was all but banned from use in the United States after researchers found that thousands of people had heart problems after taking it. Today, it is a drug of last resort for people with diabetes who are so sick that a heart attack is worth the risk.
But now, in a highly unusual move, the Food and Drug Administration has decided to reopen the case on Avandia and will ask a panel of experts this week whether the agency must reconsider the restrictions on the drug.
That is just one of several options before the advisory committee, but lifting the limits would amount to a major policy reversal and could be a huge victory for the drug’s maker, GlaxoSmithKline. Avandia was once a top-selling drug, reaching more than $3 billion in sales in 2006 before controversy flared. But critics, like Dr. Steven Nissen, the well-known Cleveland Clinic cardiologist who was the first to sound a public alarm about the drug, say it is far too dangerous to use in diabetes treatment. He said an analysis of more than 50 studies linked Avandia to an elevated risk of heart attack.
Nissen and others contend that the FDA’s decision to revisit the drug is more about saving face than protecting patients. “The efforts to whitewash this entire affair is really an unacceptable misuse of their regulatory role,” Nissen said. He added that he would be “horrified” if the panel were to recommend that the restrictions be removed.
Dr. Janet Woodcock, the FDA’s top drug official, said the two-day meeting that begins Wednesday was convened to weigh a review she requested in 2010 of an earlier clinical trial that Glaxo itself had conducted. Past findings were riddled with questions, she said, and the agency has an obligation to try to answer them.
“I made the decision last time about Avandia, and it’s not that it was an open-and-shut case,” she said in a phone interview. “What we’re trying to do here is resolve that uncertainty as much as we can with all the available data.”
While experts said widening access to the drug would be unlikely, many found it puzzling that it was even under consideration. The process and its outcome are likely to be among the most closely watched drug-safety cases in recent years.