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Location: Houston, Texas, United States

My name is David Stone. I live in Houston, Texas. I am a 30-something single white male. I am an Orthodox Christian and am a member of an English-language parish of the Russian Orthodox Church Outside of Russia (ROCOR).

Tuesday, August 23, 2005

The FDA Whistleblower

"On Nov. 18, an unassuming safety researcher from the U.S. Food and Drug Administration sat down before a Senate committee and tore his bosses to shreds."

David Graham is a research scientist with the FDA. His career at the FDA has spanned over 20 years. As this article on Forbes.com states:

"Graham is an unlikely whistleblower. For years, he has toiled at the FDA's offices, presenting data to advisory committees but not putting his face before the public. He would seem out of place in the often secular world of academic science. A father of six, Graham is a deeply religious Catholic and taught himself biblical Greek so he would be able to read the New Testament in its original language."

The article continues:

"He has rarely cried wolf--most of the medicines he flagged were eventually pulled from the market. Graham can be credited to some degree with the withdrawals of Abbott Laboratories' Omniflox, Wyeth's Fen-Phen and Redux, Warner-Lambert's Rezulin, the over-the-counter drug PPA and, of course, Merck's Vioxx."

"But Graham says that for his entire career, he's been getting heat from his bosses. "You don't get rewards for doing the work that gets a drug taken off the market," he says. "

"At a 1999 advisory panel for Rezulin, a Pfizer diabetes drug that was eventually pulled from the market for causing liver problems, Graham's slide projector broke. His data helped identify a dangerous medicine, but he only received a letter of reprimand for not having backup slides on acetate. "Nobody ever said to me, 'Oh, good job,' " Graham says. "

Another article detailing Graham's thoughts on the Vioxx verdict on Forbes.com states:

"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. "

One could certainly make the argument that the $253 million dollar damages award in the Vioxx trial is excessive and was meant by the jury to send a message. On might also be able to make the argument that perhaps just such a message is needed. Hopefully the FDA is listening now.


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