How Vioxx Exposed Conflicts of Interest at the Food and Drug Administration and The New England Journal of Medicine

Harvey Berman

ABSTRACT

This paper analyzes the twelve-month period between August 2000 and August 2001 during which Merck & Co. launched an aggressive marketing campaign for its new anti-inflammatory drug, Vioxx (rofecoxib), published its seminal VIGOR (Vioxx gastrointestinal outcomes research) study in The New England Journal of Medicine (NEJM), 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 FDA in February 2001, and, based on internal e-mails within Merck & Co., exposes what Merck & Co. scientists knew about the increased risk of heart attacks attributable to Vioxx. This paper demonstrates the following: 1) that Merck & Co.’s VIGOR study contained critical defects that should have been obvious to a careful editor; 2) that the study did not merit publication; 3) that the ad hoc Arthritis Advisory Committee sidestepped its responsibility to acknowledge the increased cardiovascular risk of the drug; and 4) that Merck & Co. knew of these increased risks while actively promoting the drug. Had the outcomes been different at the NEJM 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.

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