USATODAY.com - Lawmaker alleges FDA, Merck collaborated: "Lawmaker alleges FDA, Merck collaborated
Posted 7/19/2006 8:54 PM ETE-mail Save Print Subscribe to stories like this


Grassley
AP







WASHINGTON (AP) � A federal health official worked with drug maker Merck to discredit a government whistle-blower who publicized safety risks associated with the painkiller Vioxx, a lawmaker alleged Wednesday in seeking an investigation.
Sen. Charles Grassley, R-Iowa, asked the inspector general at the Health and Human Services Department to probe whether the Food and Drug Administration and Merck acted in concert to call into question the safety findings made by Dr. David Graham, an FDA drug safety official.
In a letter Wednesday, Grassley cited handwritten notes made by the Merck employee documenting an Oct. 13, 2004, conversation with the FDA official that suggests the two collaborated.
The FDA official mentioned an 'opportunity to get (the) message out' on Graham, a longtime employee of the agency, and provide journalists with a company critique of him, according to notes quoted in the letter.
'It is no secret that Dr. Graham was and is a critic of the FDA. However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees,' Grassley said in the letter to Inspector General Daniel Levinson. The FDA, Grassley said, must maintain a 'clear, bright line between the regulated and the regulator.'
FDA spokeswoman Susan Bro had no comment.
Merck & Co. Inc. said in a statement that it has the 'right to express our views when we believe information others have presented is not fair and balanced. Dr. Graham's conclusions with regard to Vioxx differed from those of the FDA and to that extent"