FDA May Halt Avandia Trials Due to Safety Concerns

An Avandia-Actos comparison safety study may be halted by the FDA due to safety concerns about Avandia. Avandia at one time a best selling diabetes drug for GlaxoSmithKline PLC, has come under increased scrutiny since a 2007 study found that Avandia had been linked to an increased risk of heart attack.
The current FDA study compares Avandia with a leading rival Actos for safety and efficacy but some regulators are calling into question the ethics of testing a drug that’s already questionable for its link to increased heart attack risk.
According to the Wall St. Journal, “Joshua Sharfstein, principal deputy commissioner of the FDA, tells the WSJ that no decision on the trial (called TIDE) has been made yet, and won’t be until after a July meeting about the drug. By then the agency will also have the results of an Institute of Medicine review examining the appropriateness of such head-to-head safety trials.”
In February, the Senate Finance Committee lambasted GlaxoSmithKline for withholding information about the known safety risks concerning Avandia. According to the Senate report, company officials knew for years that Avandia had serious safety issues but did not disclose the safety concerns to the public. The Senate report was also critical of the FDA for allowing the clinical trial to continue in spite of the fact that the FDA itself estimates that 83,000 heart attacks have been caused by Avandia between 1999 and 2007.
At the time of the Senate report in February, GlaxoSmithKline was involved in the study involving its rival Actos and had enrolled 16,000 trial participants. FDA researchers quoted in the Senate report were highly critical of the trial at that time stating that the study was “unethical and exploitative” since trial participants were being subject to the Avandia’s safety issues.
While the debate over the clinical trial continues, there are more than 13,000 Avandia lawsuits pending in courts around the country. The first of two US federal bellwether trials are scheduled for June 1 in Pennsylvania.