David J. Graham
David J. Graham is Associate Director of the Office of Drug Safety at the U.S. Food and Drug Administration (FDA).
Following Merck & Co.'s withdrawal of their pain medication Vioxx in September 2004 for causing an estimated 27,000 strokes, heart attacks and deaths, Graham told a U.S. Senate hearing that FDA conflicts of interest left the nation "virtually defenseless" against similar drug problems. [3]
Afterwards, Graham contacted the Government Accountability Project (GAP), a non-profit organization established to protect whistleblowers, "for advice about overcoming his supervisors' opposition to the publication of his critical findings about Vioxx."
A few weeks later, "anonymous callers" to GAP questioned Graham's credibility. GAP legal director Tom Devine said that further research suggested the anonymous callers "the callers were trying to smear [Graham]."
Devine told the Washington Post that "he is certain [the anonymous callers] were supervisors at the FDA because of the details of the arguments they made and the phone numbers from which they called. In addition, he said that, after identifying the callers to his satisfaction, he referred to them by name during subsequent phone conversations. He said the callers were surprised by his identifications but did not tell him he was wrong." [4]
In July 2006, Iowa Republican Senator Charles Grassley wrote to the inspector general at the Department of Health and Human Services seeking an investigation into whether the Food and Drug Administration and Merck collaborated to try and discredit Graham. In his letter, Grassley cited notes by a Merck employee of a conversation with an FDA official who mentioned an "opportunity to get (the) message out" on Graham and distribute the company's critique of him to journalists. [1]
In a statement to Associated Press, Merck wrote that it has "right to express our views when we believe information others have presented is not fair and balanced." In a deposition in a class action case against Merck, Graham stated the material obtained under discovery "actually demonstrates more clearly just how widespread the organized campaign to discredit and smear me was." [2]
Other SourceWatch resources
External links
- "Aug. 12, 2004: FDA official questions David Graham's findings", CBS News, October 26, 2004.
- "Aug. 13, 2004: Researcher David Graham defends his work", CBS News, October 26, 2004.
- International Society for Pharmacoepidemiology, "Correction: International Society for Pharmacoepidemiology", News Release, August 25, 2004.
- "FDA Downplayed Vioxx Doubts", CBS/Associated Press, October 26, 2004.
- Food and Drug Administration, "FDA Statement on Vioxx and Recent Allegations and the Agency's Continued Commitment to Sound Science and Peer Review", Media Release, November 17, 2004.
- Testimony of David J. Graham, MD, MPH, November 18, 2004", Consumers Union.
- Marc Kaufman, "Attempt to Discredit Whistle-Blower Alleged: Group Says His FDA Colleagues Made Calls," Washington Post, November 24, 2004.
- Jeanne Lenzer, "FDA is incapable of protecting "against another Vioxx"", British Medical Journal, November 25, 2004.
- Jeanne Lenzer, "Public interest group accuses FDA of trying to discredit whistleblower", British Medical Journal, November 25, 2004.
- Theresa Agovino, "Judge orders FDA whistleblower to testify", Associated Press, March 15, 2006.
- Andrew Bridges, "Lawmaker Alleges FDA, Merck Collaborated", Newsday, July 19, 2006. (This is an Associated Press story).
