After years of controversy, the Food and Drug Administration is gearing up to decide the fate of a popular diabetes drug, Avandia.
An FDA advisory panel of experts will meet next week to weigh the evidence against the GlaxoSmithKline drug and make a recommendation as to whether it should be pulled from the market due to health risks.
Avandia's safety was called into question in 2007 when an analysis by Dr. Steven Nissen, chair of Cardiovascular Medicine at Cleveland Clinic, showed that those on the drug had a 43 percent higher risk of heart attacks and a 64 percent higher risk of dying from heart disease.
Despite that study, an FDA panel of outside experts ruled in July of 2007 that the drug should remain on the market, though the panel recommended a "black box warning" label be added to the packaging.
Over a thousand pages of briefing material on the drug were released by the FDA this morning in preparation for the advisory committee's meeting July 13-14.
""There is not complete unanimity within the FDA about interpretation of the data. That's one of the reasons we are going to the advisory committee," Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA said in a press conference Thursday.
Panel members will vote on whether or not the data suggests that Avandia increases cardiovascular risk or mortality among patients with Type 2 diabetes. They will also vote for one of five recommended courses of action, ranging from allowing the drug to stay on the market and removing the current black box warning label to withdrawing it from the market altogether.
The FDA will take the recommendation into account when deciding Avandia's safety, but the final call will be made by the FDA, Dr. Joshua Sharfstein, principal deputy commissioner at the FDA said at the press conference.
"The FDA is making a decision on behalf of the public. We are going to try [to] make a decision as quickly as we can under the circumstances," he said.
In response to Thursday's press conference, GlaxoSmithKline released a statement reiterating past statements that six controlled clinical trials on Avandia show no increase risk of heart attack, stroke, or death.
"We look forward to…participating in a rigorous scientific discussion with the advisory committees," the statement said.
Concern over Avandia's possibly deadly side effects began to heat up this winter after a February report was released by the U.S. Food and Drug Administration's associate director of drug safety, Dr. David Graham.
The report called for Avandia to be removed from the market and said the drug could be linked to about 500 more heart attacks and 300 more cases of heart failure each month than would occur if its competitor, Actos, were used exclusively.
Meanwhile, GlaxoSmithKline has faced thousands of lawsuits brought by patients alleging that the drug caused heart attacks. Some 700 of these cases were settled in May for $60 million.
This June, further evidence against the drug was offered by two large studies published in the Journal of the American Medical Association. These studies found an increased risk of heart failure, stroke, and death among patients taking Avandia compared to those taking Actos.
More recently, a Canadian study, released in June 2010 suggested that using a half-dose of Avandia, paired with another diabetes medicine, metformin, was associated with similar efficacy with fewer side effects.