UPDATED: FDA advisers vote for looser reins on GlaxoSmithKline's Avandia

It took multiple tries and a vote tallied on paper to make sure everything was correct, but finally, we have a verdict. After two days of hearings, on Thursday an advisory panel recommended the FDA keep Avandia on the market and ease restrictions on its use. Now the FDA says it will carefully evalute and decide how to act.

Thirteen members of the advisory panel supported modification, Reuters reports, while 7 panelists voted to remove all restrictions. Five others recommended keeping the restrictions on the drug as-is. One voted to withdraw Avandia from the market completely.

"We appreciate the committee's thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendation of the committee," Dr. James Shannon, GSK's chief medical officer, said in a statement. "We continue to believe that Avandia is a safe and effective treatment option for Type 2 diabetes when used for the appropriate patient and in accordance with labelling."

While the FDA tends to act on recommendations from its advisory panels, Robert Temple, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, told The New York Times that the advice to modify restrictions "came in multiple flavors" and that the agency would incorporate all suggestions when making the final call. "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 deeply divided panel reflects the wide range of opinions and evidence questioned and discussed this week. Much of Wednesday's hearings focused on a readjudication of 2010's RECORD trial. The reanalysis, conducted by the Duke Clinical Research Institute, showed no statistically significant cardiovascular death risk from the diabetes drug. But concerns about the study's independence, the integrity of its data and the design of the original trial led to a heated back-and-forth that seemed to yield more questions than answers.

Despite the recommendation, it may be too late for the once-blockbuster treatment to recoup any significant revenue. Down from $3 billion a year before its safety came into question, Avandia posted only $9.5 million in sales last year. Glaxo ($GSK) stopped promoting the drug in 2010 after the restrictions were imposed, and the patent on Avandia expired in 2011 (with the FDA approving a Teva generic in January, a Glaxo spokeswoman told Bloomberg). "The train may have already left the station on this. I'm not sure what the practical results of this will be," said David Oakes, a professor and panel member who voted to remove the restrictions, as quoted by Bloomberg.

Avandia--and the decision to reopen this case--has sparked one of the biggest controversies in the drug world in recent memory. Plenty have made their opinions known, both in support and condemnation of the drug. While the panel has made its recommendation, as always the FDA will have the final say on what happens with Avandia. And now, we wait.

- here's Glaxo's release
- and the NYT story
- read the Bloomberg piece
- see Reuters' take
- get more from Forbes

Editor's note: The story has been updated with the statement from GSK and information from The New York Times.