GlaxoSmithKline's controversial diabetes drug Avandia, restricted in the US and banned in Europe over concerns it raises heart attack risk, is getting a second look this week by US medical experts.
An independent advisory panel to the US Food and Drug Administration began two days of meetings Wednesday to decide whether to urge regulators to keep restrictions on the drug, or to allow the drug to be more widely available.
Once a blockbuster drug for patients with type 2 diabetes, Avandia was approved in 1999 and soared to sales of three billion dollars per year, but its use has declined dramatically in recent years.
The experts convened by the FDA are debating a new review of the GSK trial called RECORD, which confirmed the company's initial finding that Avandia does not raise cardiac risk any more than other diabetes drugs on the market.
The British pharma giant GSK recently paid researchers at Duke University in North Carolina to carry out this new analysis of the data.
FDA experts said this week on the agency's web site that the Duke review was "rigorous" and "overall... supports the previous observation that, in this trial, rosiglitazone was not associated with increased all-cause mortality or increased cardiovascular mortality," referring to the active ingredient in Avandia.
However, other research has pointed to a rise in heart attack and stroke among patients using Avandia to control their blood sugar, and some critics have said the RECORD trial—which showed it was safe—was actually flawed.
"The uncertainty about the risk of Avandia is overwhelmingly the most important reason for the differing opinions on the regulatory actions that have been taken on this medication," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research.
"Therefore, we have an obligation to better understand the trade-offs based on as much scientific evidence as possible."
The controversy over Avandia erupted after a 2007 study in the New England Journal of Medicine found that it raised the risk of heart attack by 43 percent.
The lead author of that study, Steven Nissen de la Cleveland Clinic, has been outspoken against Avandia and told the Wall Street Journal this week that RECORD was "not conducted in a scientifically acceptable manner."
He also said that his request to be part of the committee of experts reviewing the data was denied by the FDA.
In 2010, the FDA slapped tight restrictions on use of Avandia, following the recommendations of independent experts who had concluded the drug significantly raised the risk of heart attacks.
A decision is expected Thursday by the 28-member panel, whose advice the FDA does not have to follow but usually does.