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No one person has come to more represent the big questions about drug safety that emerged following the withdrawal of Merck's painkiller Vioxx® than the Food and Drug Administration's Dr. David Graham. The $253 million dollar verdict awarded to the Widow of one Vioxx® patient has caused Dr. Graham, who works in the FDA's Office of Drug Safety, to be more critical than ever.
"If the judgment is that there's blood on Merck's hands," Dr. Graham says, "there's blood on the FDA's hands as well."
Dr. Graham has estimated that Vioxx® killed some 60,000 patients. 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."
According to Dr. Graham, 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 in the market when problems occur. "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.
Dr. Graham believes that there should be formal, periodic reviews of the safety of new drugs and that the FDA should release documents that explain its reasoning.
A new bill currently before Congress, created by Senators Chuck Grassley and Christopher Dodd, would create a new office of drug safety at the FDA. Dr. Graham thinks that this could prevent future disasters.
Since Vioxx® was taken off the market, a firestorm of controversy has encased the drug industry, also touching in one way or another Bextra®, from Pfizer; Natrecor®, from Johnson & Johnson; Accutane®, from Roche; and Meridia®, from Abbott Laboratories. The wave of controversy shows no signs of stopping making Dr. Graham on of its most outspoken figures.
"Today Merck was on trial, and judgment was rendered," he says. "But when will the public hold the FDA accountable for its role, its complicity, in this catastrophe?"
If you believe that you or a relative were injured by taking Vioxx® please use the form below to contact our law firm.
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