FDA Panel Splits Over Avandia Ban
20-12 Vote to Strengthen Avandia Warning, but Many Panelists Want Ban
Critics: Avandia Clinical Trial Unethical continued...
That's because the FDA itself is split over the Avandia question. The split is over a philosophical question: Should safety concerns take priority, or should the FDA focus on the need of patients (and drugmakers) for new treatments?
It's not an easy question, especially as the Avandia controversy has called into question the quality of data submitted to the FDA. Avandia maker GlaxoSmithKline has come under fire for hiding unfavorable data on Avandia and for irregularities in handling and interpreting clinical trial data.
The panel also voted:
- 18-6 that available data suggest Avandia increases heart attack risk more than do other classes of diabetes drugs. Nine panelists said they did not have enough data to decide.
- 21-3 that available data suggest Avandia increases heart attack risk more than does Actos. Nine panelists said they did not have enough data to decide.
- 21-1 that there is not enough data to show that Avandia increases risk of death more than other classes of diabetes drugs. Eleven panelists said they did not have enough data to decide.
The panel also voted 19-11 to continue with a clinical trial, nicknamed TIDE, comparing Avandia to Actos. Critics of the study say the trial is unethical, as it is basically asking patients to take Avandia to see if it harms them. But most panelists, frustrated by two days of inconclusive study presentations, want to see some answers -- even if it takes years.
Oddly, panel members who voted to ban Avandia voted to continue the TIDE trial. One such panelist was Marvin Konstam, MD, professor of cardiology at Tufts University, Boston.
"The panel vote was to leave the drug on the market, and so we will need this study," Konstam said. "You need to inform the patient enrolled in the trial that the only reason Avandia is in the study is to see if it harms you. That is a problem."