On November 18, 2004, FDA epidemiologist David J. Graham testified before the U.S. Senate Finance Committee after Merck withdrew the anti-inflammatory drug Vioxx the previous month because of serious safety concerns. Graham said he personally believed the FDA’s internal policies were inadequate to protect patients from drugs with unacceptable risks, stating that the agency was “virtually defenseless” against another Vioxx. He was subsequently criticized publicly by the FDA and sought advice from the Government Accountability Project, a whistleblower-protection organization, after superiors objected to publishing his findings.
Graham later argued that the FDA was institutionally biased toward pharmaceutical companies and focused too heavily on approving drugs rather than determining whether they were safe or necessary. His broader career involved post-approval safety investigations that contributed to the removal or restriction of drugs including Rezulin, Fen-Phen, Redux, Lotronex, Baycol, Seldane, Propulsid, and Trovan. In 2010, Graham and FDA colleague Kate Gelperin also urged that Avandia be removed, citing evidence of possible increased mortality, although their findings did not show the increased heart-attack risk reported by other studies. The episode remains a documented case of internal disagreement over pharmaceutical safety surveillance and FDA accountability.
