Dr. Clifford J. Rosen, director of clinical and translational medicine at the Maine Medical Center in Portland, led the advisory committee that on 2010 set strict limits on the use of the diabetes drug Avandia after it was linked to heart problems.
The New York Times reported on Sunday on the FDA’s meeting this week, where the restriction will be reconsidered.
More here from the FDA.Rosen tells the NY Times that would be a bad idea :“It’s turning back the clock. …I have no idea why they would revisit this issue. It’s a done deal.”
That is just one of several options before the advisory committee, but lifting the limits would amount to a major policy reversal and could be a huge victory for the drug’s maker, GlaxoSmithKline. Avandia was once a top-selling drug, reaching more than $3 billion in sales in 2006 before controversy flared. It could also help rewrite one of the most embarrassing chapters in the F.D.A.’s recent history.
But critics, like Dr. Steven Nissen, the well-known Cleveland Clinic cardiologist who was the first to sound a public alarm about the drug, say it is far too dangerous to use in diabetes treatment. He said an analysis of more than 50 studies linked Avandia to an elevated risk of heart attack; one study linked the drug to more than 47,000 cases of heart attack, stroke or heart failure from 1999 to 2009.
Dr. Nissen and others contend that the F.D.A.’s decision to revisit the drug is more about saving face than protecting patients.
The issue is being takes at a joint meeting of the FDA’s endocrine and drug safety panels.
Sonia Hernandez-Diaz is a member of the Harvard School of Public Health is a member of the Drug Safety and Risk Management Advisory Committee.
A second look at GlaxoSmithKline Plc (GSK)’s once-best-selling diabetes pill found it doesn’t increase overall cardiac death risk, U.S. regulators said.
Findings by London-based Glaxo that Avandia doesn’t raise the overall risk of death, heart attack or stroke appear to be supported in a reanalysis by independent researchers, some Food and Drug Administration staff said in a report today. FDA advisers will reconsider restrictions imposed on Avandia in 2010 at a meeting June 5-6, according to the report.