There have been recent allegations that a federal health official worked with the drug maker, Merck, to discredit a government whistleblower that exposed the potentially fatal risks associated with the painkiller Vioxx. The allegations came from Sen. Charles Grassley, R-Iowa, who is now overseeing an investigation into the matter.
Sen. Grassley asked the inspector general at the Health and Human Services Department to probe whether the Food and Drug Administration and Merck acted together to call into question the safety findings made by Dr. David Graham, an FDA drug safety official.
In a letter on Wednesday, Grassley cited handwritten notes made by the Merck employee documenting an October 13, 2004 conversation with the FDA official that suggests the two collaborated.
According to the notes quoted in the letter, 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 on him.
According to Grassley in the letter to Inspector General Daniel Levinson, “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, the FDA must maintain a “clear, bright line between the related and the regulator.”
The spokesperson for the FDA, Susan Bro, had no comment on the issue.
In a statement, Merck & Co, Inc. said that it has the right to express their views when they believe information others have presented is not “fair and balanced”. Merck said, “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.”
In September 2004, Merck announced the voluntary withdrawal of Vioxx, citing a study that revealed the pain medication could double the risk of a stroke or heart attack if taken for 18 months or longer.
Two months later, Graham testified before a Senate committee that the FDA fumbled the handling of Vioxx, and mishandled safety problems with five other commonly used drugs on the market. The FDA defended its oversight of Vioxx before the hearing; an agency official later dismissed Graham’s research as “junk science.”
The following month, 22 members of Congress signed a letter requesting the FDA to investigate the “smear campaign” against him.
Merck is now facing more than 16,000 Vioxx-related lawsuits.
The meeting mentioned by Grassley took place two weeks after the drug was withdrawn.
The Associated Press viewed FDA e-mails indicating 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 practice was commonplace.
Merck then issued a statement indicating that it stood by the safety of Vioxx. At the time, an FDA spokesperson said removing Vioxx was “not on the table”.
The notes obtained by Grassley indicate the FDA later went even further in helping Merck rebut Graham’s work.
According to the notes which were admitted as evidence in a federal Vioxx trial, the FDA’s Dr. Brian Harvey suggested to Merck’s Dr. Ned Braunstein “an official rebuttal on Graham.”
Graham said he was “quite shocked” to learn about Braunstein’s notes.
On May 9, 2006 during a sworn deposition, Graham said, “This actually demonstrates more clearly just how widespread the organized campaign to discredit and smear me was.”
Attorneys for Merck have sought to keep portions of the deposition from jurors, saying they go beyond what Graham has previously said.