In addition to Vioxx, Graham named five other drugs that are putting the lives of the public at risk. The five drugs in question are:
Graham stated that the FDA's inability to protect Americans from another case similar to the Vioxx case was clear evidence that massive changes need to be implemented for the future protection of the public.
One of the regulatory changes Graham proposed was granting the Office of Drug Safety independent regulatory authority. Presently, safety officers are faced with a conflict of interest in the event they have to convince the Office of New Drugs that a drug is causing side effects. The conflict arises because the very group that approved the drug in the first place is also responsible for taking regulatory action against any post-marketing activities.
Graham's Future
Tom Devine, Graham's lawyer, stated that Graham would be exiled from his duties of reviewing drugs and placed in the office of the commissioner. Devine described this position as "filling space under the scrutinizing watch of a babysitter."
USA Today November 25, 2004
British Medical Journal November 27, 2004
Dr. David Graham is one of my new heroes. He is the person who blew the whistle on the FDA when he testified before Congress about Vioxx late in November.
So what does Dr. Graham get for blowing the whistle?
He's going to be exiled from his work reviewing drugs and put to work in the office of the commissioner. The irony here is unmistakable. First, the FDA is quietly let off the hook after approving a drug responsible for causing almost 139,000 deaths, and then the person who speaks out against this is stripped of his job responsibilities.
I look up to Dr. Graham not only for his honest testimony and concern for public safety, but for the integrity of his character. His background information includes father to six children, assistant scoutmaster and a wiry long-distance runner turned backpacker who, when flummoxed, begins sentences with an "Oh, golly." He is no slacker, as he was educated at one of the leading medical schools in the world, Johns Hopkins University School of Medicine. He also attended Yale and the University of Pennsylvania.
This is a man of conviction, and he will likely be one of the single leading forces making a dent in this fatally flawed paradigm. Perhaps I am biased because he is a fellow runner, but I LOVE this guy and hope I will be able to meet him some day.
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$30 Billion Vioxx Recall -- The Dangers, Powerful Lessons & Safe Alternatives that Everyone Must Know
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Before Vioxx Was Pulled From the Market the FDA Approved it For Kids!
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