July 21st, 2010
FDA Halts New Enrollment in TIDE
Larry Husten, PHD
The FDA has halted new enrollment in TIDE (Thiazolidinedione Intervention with Vitamin D Evaluation), the controversial Avandia safety study, by placing the study on “partial clinical hold.” Patients already enrolled in the trial will continue to participate. The FDA said in a statement that it had instructed GlaxoSmithKline to “update investigators, institutional review boards (IRBs) and ethics committees […]
July 20th, 2010
Avandia Panelist Received Money from GSK
Larry Husten, PHD
One of the voting members of last week’s controversial Avandia panel received speaking fees from GlaxoSmithKline, the manufacturer of Avandia, according to news reports in the Wall Street Journal and Pharmalot. The FDA had previously said that there were no relevant conflicts for any of the 33 voting members of the panel. David Capuzzi, an endocrinologist at […]