In 2011, the FDA yanked the diabetes drug Avandia from most of its market because of unacceptably high cardiovascular risks. As we blogged then, the risk of heart attack for people using the drug was shown to increase by about 40% for those with type 2 diabetes, a population already at increased risk of heart problems.
Earlier this month, an FDA review panel voted to relax restrictions on Avandia. As reported by the New York Times, the decision wasn’t the result of Avandia being recompounded into a less dangerous drug; it was the result of members of the advisory panel believing that doctors should have more freedom to prescribe it.
Usually, the FDA takes the advice of its advisory panels. But usually, such recommendations are more concrete than this unspecific recommendation. Robert Temple, deputy director for clinical science at the agency’s Center for Drug Evaluation and Research, told the paper that “A fairly large fraction of people thought there should be some kind of modification,” he said. “We’ve got to read the text and see what they said, and decide.”
The panel’s recommendation was the culmination of much drama and politics over the science involved in the studies demonstrating Avandia’s effects on heart health. The controversy was detailed recently in a story on Forbes.com.
The recommendation was a hollow victory for Avandia’s manufacturer, GlaxoSmithKline, which has a long record of legal trouble associated with its smarmy promotional practices. (See our blog, “GlaxoSmithKline Settlement Sets a Record for Penalties and Consumer Abuse.” )
Glaxo had defended Avandia despite allegations that it had mishandled the results of a clinical trial and had obscured its risks. Before Steven Nissen, a cardiologist, raised questions, Avandia had tallied more than $3 billion in sales.
But even if the FDA ultimately permits wider marketing of Avandia, sales probably won’t be as impressive. Avandia’s patent expired in 2011, and another drug company has approval to sell a generic version of it. But it has not moved it to market, probably because of Avandia’s restrictions and its small market of only about 3,400 patients.
Until the FDA finally decides if and how to reauthorize the drug, it may be used, as The Times described, only if patients have failed to respond to other drugs. It may be sold only by certain pharmacies, and doctors and patients must acknowledge that they understand the risks.
And clearly, this is a risky drug. One doctor on the panel who voted to relax restrictions told The Times that use of the drug was still risky, and if sales suddenly spiked “that would mean that physicians and patients have gotten the wrong message from these deliberations. The panel never exonerated [Avandia].”
Of the 12 panelists who voted to remove Avandia from the market in 2010, only three were at this meeting, even though the FDA said everyone who had attended the 2010 meeting had been invited. Only one panelist voted to remove Avandia from the market altogether.
Another who was present for both meetings voted to remove Avandia from the market in 2010, but this time voted to loosen the restrictions. He told The Times that the review had not alleviated his concern about Avandia’s safety, “but in my mind they move the needle in the direction to shift the burden in decision-making [to doctors].”