FDA Panel Splits Over Avandia Ban
20-12 Vote to Strengthen Avandia Warning, but Many Panelists Want Ban
Critics: Avandia Clinical Trial Unethical continued...
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."