On June 6, 2007, University of Washington medicine and epidemiology professor Bruce Psaty testified that GlaxoSmithKline (GSK) did not address safety questions in Avandia trials. Instead, he said, the trials focused on marketing questions.

Psaty wrote editorials accompanying Dr. Steve Nissen’s recent meta-analysis of Avandia published in the New England Journal of Medicine.

“GSK did not make a serious effort to verify the presumed health benefits of Avandia in a timely fashion,” Psaty testified at a congressional hearing of Avandia. “The…trials focused largely on marketing questions and failed to address directly questions of heart-attack risk or benefits.”

He also said the U.S. Food and Drug Administration (FDA) lacks the leadership and authority to require pharmaceutical companies to conduct high-quality trials.

“If sponsors do not voluntarily initiate large long-term trials of public health importance, then the FDA needs the authority to insist that they do so in a timely fashion,” he said.

GSK has conducted a trial, called RECORD; but Psaty said it is limited and, even if the study is finished, it will not be complete.

“GSK’s RECORD study has several major limitations in design and conduct, and even if it continues to its planned conclusion, information about heart attack risk from the RECORD trial is likely to be incomplete,” Psaty said.

With Avandia, he claims, the FDA failed in warning and informing consumers of the risks associated with the drug. He added that the U.S. product label for Avandia still does not identify heart attack as a potential reaction in diabetics.

Psaty says there is a crisis in confidence about the safety of medicines in America that began with the withdrawal of rofecoxib (Vioxx), a drug developed to treat osteoarthritis. Vioxx was recalled in September 2004 because it was found to increase heart attack and strokes. Vioxx was one of the most widely used medications to ever be withdrawn from the market.

The FDA has still not announced an Avandia, recall.

Sources: “Testimony of Bruce M. Psaty, M.D., Ph.D.,” before the House Committee on Oversight and Government Reform, June 6, 2007; “Rofecoxib,” Wikipedia, June 8, 2007.