In a letter to Inspector General Daniel Levinson, Grassley charges that documentation of the FDA and Merck shows the two joined forces to discredit Graham, who "blew the whistle" on the painkiller Vioxx, which Merck voluntarily withdrew from the market following a study that revealed its potential dangers.
"It is no secret that Dr. Graham was and is a critic of the FDA," Grassley says. "However, that does not mean that the FDA should scheme with drug sponsors to discredit its own employees." Grassley says the FDA must maintain a "clear, bright line between the regulated and the regulator."
Susan Bro, spokeswoman for the FDA, had no comment, though Merck -- which is currently facing more than 16,000 Vioxx-related lawsuits -- issued a statement saying that it has the "right to express our views when we believe information others have presented is not fair and balanced."
However, Grassley alleges that the campaign waged against Graham by Merck and the FDA goes far beyond the drug maker's right to "express (its) views," citing as evidence handwritten notes made by a Merck employee who documented an Oct. 13, 2004 conversation with an FDA official who mentioned an "opportunity to get (the) message out" on Graham.
In a May 2006 deposition, Graham said he was "quite shocked" to learn of some of the alleged smear campaign tactics waged against him.
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