An FDA official worked with drug maker Merck to discredit a government whistleblower 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 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, the FDA and Merck separately expressed their scientific views to the public and scientific community.”
Merck announced the voluntary withdrawal of Vioxx in September 2004, citing a study that showed the pain medication could double risk of heart attack or stroke if taken for 18 months or longer.
Two months later, Graham testified before a Senate committee that the FDA had fumbled its handling of Vioxx, and mishandled safety problems with five other widely used drugs. The FDA defended its oversight of Vioxx before the hearing; an agency official later dismissed Graham's research as “junk science.”
Merck now faces more than 16,000 Vioxx-related lawsuits.
The meeting cited by Grassley was held two weeks after the drug was withdrawn.
FDA e-mails seen by The Associated Press indicate that the agency shared in advance with Merck details about a presentation that Graham was to make in France in August 2004 about the dangers of Vioxx. The e-mails suggested that such a practice was commonplace.
Merck then issued a statement saying it stood by the safety of Vioxx. An FDA spokeswoman at the time said removing the drug was “not on the table.”
The notes excerpted by Grassley indicate the FDA later went even further in helping Merck rebut Graham's work.
The FDA's Dr. Brian Harvey suggested to Merck's Dr. Ned Braunstein “an official rebuttal on Graham,” according to the notes, which were admitted as evidence in a federal Vioxx trial.
Source: theday.com
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