Drug Expert Accuses FDA of Turning Blind Eye to Vioxx Warnings

Dr. David J. Graham, Associate Director for Science in the Food and Drug Administration Drug Center's Office of Drug Safety, disclosed during a Senate investigation that he faced stiff resistance within the FDA when he reported findings that patients taking Merck's anti-inflammatory drug Vioxx faced increased risks for heart attack and strokes.

The senate investigation comes after Dr. Graham lead a research project revealing that high doses of Vioxx tripled risks of heart attacks and sudden cardiac death. Sen. Chuck Grassley, the chairman of the Senate Finance Committee, indicated that the FDA silenced Dr. Graham's safety concerns only weeks prior to Merck & Co.'s late September announcement that it was pulling Vioxx due to health risks associated with the drug. The senator from Iowa went on to describe an environment within the FDA where the drug expert was ostracized, intimidated, and subjected to veiled threats.

Graham was scheduled to present his findings during an FDA-funded visit to an epidemiology conference in France in late August. After the FDA reviewed the abstract of Graham's presentation, Graham alleges that he encountered resistance from the FDA and pressure to amend his recommendation that Vioxx doses higher than 25 milligrams per day should be avoided. The FDA responded that any revisions Graham made to his abstract conclusion were made voluntarily.

During his senate interview, Dr. Graham also indicated that the pressures he faced regarding the open expression of health risk concerns were not limited to those surrounding Vioxx. The drug researcher and twenty-year FDA veteran stated that raising safety concerns within the agency is extremely difficult in general. The FDA countered that the agency "values open discussion" and encourages "frank exchange about scientific and medical issues".

The Senate Finance Committee is among three Congressional committees scrutinizing recent FDA actions. The Government Accountability Office (GAO) was already been investigating the FDA after accusations that the agency silenced another FDA employee who raised concerns that antidepressants may increase suicidal tendencies in children. Following the recent Vioxx controversy, GAO was asked to expand the scope of its inquiry.

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