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.
Avandia's Tumultuous History
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.
However, this study was not designed to assess the cardiovascular risk of such a drug cocktail and hence could not speak to the heart health controversy surrounding the drug, Dr. Bernard Zinman, lead author of the study, told ABCNews.com at the time of publication.
"This is a desperate attempt to salvage a dangerous drug," Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said of the study. Wolfe urged that trials on Avandia, known clinically as rosiglitazone, be halted due to the mounting evidence that the drug brings with it significant risk of heart attack, weight gain, and other health risks.
Though the drug has lost more than half of its sales since the 2007 study, it still generated more than $1 billion in revenue and was prescribed to 2.6 million Americans in 2009.
Long-time Debate Among Physicians Over Avandia
The controversy surrounding Avandia has spurred heated debate among diabetes experts.
After further evidence mounted against Avandia this June, many diabetes experts called for discontinuing use of the drug.
Considering that people with diabetes are already twice as likely as those without the disease to suffer from heart attack or stroke, many experts felt Avandia was just not worth the risk.
"The whole purpose of treating diabetes in the first place is to prevent the complications of diabetes -- chief of which is heart disease, stroke, and premature mortality," Graham told ABCnews.com. "What sense does it make to give a drug that increases all three?"
And many experts agree, saying they stopped prescribing Avandia to patients when reports were first released about its potential harm.
"I have not used Avandia for years," Dr. John Messmer, associate professor of family and community medicine at Pennsylvania State College of Medicine told ABCnews.com. "I noted that too many of my patients retained fluid, became hypertensive and even had worsening heart failure, so I discontinued using it even before the warnings came out."
Other doctors felt that the results of Avandia studies were not so clear-cut and that political agendas may be influencing the call to remove an effective drug from the market.
According to the Dr. Domenic Sica, chairman of clinical pharmacology and hypertension at Virgina Commonwealth University in Richmond, many studies released on Avandia are not as strong as the study authors typically present.
"Sometimes the motivation for attacking a drug is personal, and it is often quite difficult in separating out the really bad with a drug from the perception of bad on the part of an author," Sica told ABCnews.com after the June studies were released. "Do I think that this drug should be pulled from the market? No."