The Vioxx Verdict

David Graham, who works in the FDA's Office of Drug Safety, has come to more represent the big questions about drug safety that emerged following the withdrawal of Merck's painkiller Vioxx.

"If the judgment is that there's blood on Merck's (nyse: MRK - news - people ) hands," Graham says, "there's blood on the FDA's hands as well."

"Today Merck was on trial, and a judgment was rendered," he added. "But when will the public hold the FDA accountable for its role, its complicity, in this catastrophe?"

Graham has estimated that Vioxx killed some 60,000 patients--as many people, he points out, as died in the Vietnam War. He says that fundamental problems at the FDA led to those deaths. "People should turn to Congress and demand a drug safety system that is free from corporate influence--and a distinct center for drug safety."

In Graham's eyes, the problem at the FDA is that the same scientists who approve drugs are the ones charged with deciding whether or not they are safe enough to remain on the market when problems crop up. "There is no feedback or review process to say, 'You guys have made a big mistake,' " he says. When problems are recognized by drug safety officers, it can be hard for the message to take hold.

Graham says that he thinks there should be formal, periodic reviews of the safety of new medicines--and that the FDA should release documents that explain its reasoning.

"The FDA does not think anything it did is a mistake," he says. "None of its decisions are evidence-based."