The Food and Drug Law Journal, Vol. 75 (4) 2021, includes a paper by Romanell Fellow Harvey A. Berman, PhD, MPH, Department of Pharmacology and Toxicology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo. The advance copy of Berman's paper, How Vioxx exposed conflicts of interest at the Food and Drug Administration and The New England Journal of Medicine, is here.
Abstract: The paper analyzes the 12-month period between August 2000-August 2001 during which Merck-&-Co launched an aggressive marketing campaign for its new anti-inflammatory drug, Vioxx (rofecoxib), published its seminal VIGOR study in the New England Journal of Medicine, and applied to FDA to extend the clinical indications of Vioxx to include rheumatoid arthritis. This paper examines the VIGOR study as it was published, analyzes the deliberations of the ad hoc Arthritis Advisory Committee convened by the FDA in February 2001 and, based on internal e-mails within Merck, exposes what Merck scientists knew about the increased risk of heart attacks attributable to Vioxx. We demonstrate the following: that Merck’s VIGOR study contained critical defects that should have been obvious to a careful editor, that the study did not merit publication, that the ad hoc Arthritis Advisory Committee sidestepped its responsibility to acknowledge the increased cardiovascular risk of the drug, and that Merck knew of these increased risks while actively promoting the drug. Had the outcomes been different at the Journal or the ad hoc Arthritis Advisory Committee, Vioxx would not have been approved, further systematic studies on cardiovascular risk would have been mandated, and thousands of lives might have been spared the risks of fatal and non-fatal heart attacks clearly known but deliberately obscured, misrepresented, and dismissed by each of the participants.
The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industry regulations. It is published by the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. Learn more about the Journal.