by Erika Edwards
July 13, 2010
Since it hit the market in 1999, Avandia has made millions for maker Glaxo Smith Kline, but within the next 24 hours, Food and Drug Administration advisors could vote to yank it off the market.
But with conflicting data from drug companies, outside experts, even within the FDA, panel members have their work cut out for them.
"It is not typical for an FDA commissioner to an address an advisory committee," said Margaret Hamburg, M.D., Commissioner, FDA.
FDA head Margaret Hamburg's un-typical appearance shows how seriously the agency is taking this meeting.
In 2007 the diabetes drug, Avandia, was given a black box warning after studies found it increased the risk for heart problems, but a narrow vote from FDA advisors kept it on the market.
Now more recent studies are available for a new panel of advisors to review and potentially vote to pull the drug.
But coming to a conclusion depends on whose interpretation of the data they use.
Researchers with Avandia's maker, Glaxo Smith Kline, say diabetics need treatment options.
"Overall when used appropriately rosiglitazone has a positive benefit/risk profile," said Murray Stewart, D.M., VP of Clinical Development, GlaxoSmithKline
Independent researchers say the heart risks are too steep.
"Continued marketing of rosiglitazone cannot be medically or ethically justified," said Steven Nissen, M.D., Cleveland Clinic.
Normally panel members have clear data from the FDA to review before they make their decision, but this time FDA experts cannot seem to find a middle ground with their own colleagues.
"Having changed some of the data he provides analysis and comments. And we don't agree with this approach in the Office of New Drugs," said Ellis Unger, M.D., Deputy Director, FDA.
With so many competing views to sort through, Dr. Hamburg had one piece of advice for panel members:
"Follow the science wherever it leads and the rest will fall into place."
The panel has been asked to decide whether the drug should remain on the market with additional warnings or be taken off completely.
The FDA is not required to follow the advice of the advisory committee.
Some experts say how the agency handles tomorrow's recommendation will define how it will treat future controversial drug decisions.