As we wrote not too long ago, South Carolina is in the Diabetes Belt, with about 450,000 of our residents suffering from diabetes. (Read more here https://www.louthianlaw.com/blog/2013/10/lipitor-link-diabetes/)
In the news this week is an announcement by the Federal Drug Administration (FDA) that prescription drug Avandia will now be widely available to treat type 2 diabetes. This represents an about-face by the agency, because they restricted use of Avandia after 2007 clinical trials indicated the drug increases the risk of heart attacks or death. [More: Prescription Drug Injuries]
Originally approved in 1999, Avandia was once the most widely used prescription drug for diabetes; however, under pressure from Congress following the negative research results, in 2010 the FDA said it was to be used only as a drug of last resort for certain patients, and those patients had to sign a waiver that they understood the drug’s risks before getting a prescription. Avandia went from being a $3 million per year seller to being a pill taken by only 3,000 in the whole U.S.
So why the change of course? The FDA instructed GlaxoSmithKline, Avandia’s British manufacturer, to finance an independent study. GSK hired Duke University to reanalyze the initial study. Duke released its findings in 2012, agreeing with GSK’s conclusions that Avandia does not appear to increase the risk of heart attack compared to standard treatments. Based on Duke’s findings, a panel of outside experts recommended in June 2013 that restrictions on Avandia be lifted. Now the FDA has done so.
Some physicians say it is unlikely that Avandia will be widely prescribed now, as other diabetes drugs have come on the market to replace it. CBS News quoted Dr. Ronald Tamler, clinical director of the Mount Sinai Diabetes Center in New York as saying, “The decision by the FDA is irrelevant in clinical practice. Patients have been reading about increased risk of cardiovascular events with (Avandia) since 2007 and will not abandon their concerns overnight, despite the FDA decision.”
We have to wonder: If GlaxoSmithKline was funding the Duke study, was it truly unbiased? Is this reversal by the FDA an attempt to save face, as Dr. Steven Nissen, a cardiologist with the Cleveland Clinic, charges? Does GSK have clean hands now when in 2012, as part of a $3 billion settlement with the Department of Justice for various criminal and civil violations involving 10 of their drugs, they pleaded guilty to failing to report safety problems with Avandia to government officials over a seven-year period?
The Louthian Law Firm has been advocating for decades on behalf of South Carolinians injured by defective drugs or medical devices. If you or someone you care about has been harmed by a diabetes drug, contact us through our toll-free number (888-926-0051) or locally in Columbia at 803-454-1200.