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David Graham
FDA Associate Director for Science and Medicine
FDA whistleblower who exposed the Vioxx cardiovascular death cover-up and systematic failures in drug safety oversight
Overview
David J. Graham (born 1950) is an American epidemiologist and drug safety officer who served as Associate Director for Science and Medicine in the FDA Office of Surveillance and Epidemiology. In 2004, Graham became a central figure in the Vioxx (rofecoxib) scandal when he presented research at a scientific conference estimating that Vioxx had caused between 88,000 and 139,000 excess cases of serious coronary heart disease in the United States, with approximately 55,000 deaths attributable to the drug. When Graham attempted to publish his findings, FDA leadership attempted to suppress his research and pressure him to alter his conclusions. He subsequently testified before the U.S. Senate Finance Committee, where he described the FDA as "incapable of protecting America against another Vioxx" and called the agency fundamentally broken in its approach to post-market drug safety. Graham identified five other drugs he believed should be withdrawn for safety reasons. His testimony was pivotal in reforming FDA safety surveillance procedures.
Key Affiliations
Controversies & Concerns
FDA leadership attempted to suppress his Vioxx research and pressured him to alter conclusions showing 55,000+ deaths
Testified before Senate Finance Committee that the FDA was "incapable of protecting America against another Vioxx"
Identified five additional FDA-approved drugs he believed should be withdrawn for safety: Meridia, Crestor, Accutane, Bextra, and Serevent
Described the FDA drug safety office as having a "broken culture" that prioritized industry relationships over public safety
Faced retaliation from FDA superiors after going public with Vioxx data; required congressional protection
Related Investigations (1)
Known Associates & Connections
Charles Grassley
U.S. Senator (R-IA) who chaired the Finance Committee investigation and provided Graham with whistleblower protections
Sources & Documentation
2 documented sources from official records, investigations, and reports
Senate Finance Committee: Testimony of David Graham, M.D., M.P.H.(2004-11-18)
The Lancet: David Graham on Vioxx, the FDA, and Drug Safety(2005)
Personal Information
- Born
- 1950
- Birthplace
- United States
Education
- •Johns Hopkins University (M.D.)
- •Johns Hopkins Bloomberg School of Public Health (M.P.H.)
Key Timeline
1984
Joins the FDA Office of Drug Safety as an epidemiologist
2004-08
Presents research at International Conference on Pharmacoepidemiology estimating 88,000-139,000 excess cardiac events from Vioxx
2004-09-30
Merck voluntarily withdraws Vioxx from the market after internal study confirms doubled cardiovascular risk
2004-11-18
Testifies before U.S. Senate Finance Committee, calling the FDA "incapable of protecting America against another Vioxx"
2007
FDA Safety and Innovation Act reforms post-market surveillance partly as a result of Vioxx scandal and Graham testimony