Consumer advocacy group reiterates calls for halt to Avandia trial

The consumer advocacy group Public Citizen on Wednesday reiterated its call for the Food and Drug Administration to halt clinical trials of the diabetes drug Avandia.

The FDA has halted the recruitment of new patients, but Public Citizen’s Health Research Group Director Sidney Wolfe said that’s not enough — especially after an FDA advisory panel last week recommended extra safety warnings and restrictions on the drug’s use after it was linked to a heightened heart-attack risk. Twelve people on the 33-member panel voted to pull the drug from the market, and three voted for no change.

“By failing to completely stop the TIDE trial and to ban the drug,” Wolfe said, “the FDA is not only guaranteeing that the 1,100 patients in the TIDE trial continue to be subjected to an unacceptably dangerous drug, but also hundreds of thousands of people will continue to use the drug in this country.”