Merck & Co. Inc. had Enough Information to Know of the Dangers of VIOXX in December of 2000, Nearly Four Years before It Pulled the Drug
A recent article entitled Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarketing Pharmaceutical Safety Surveillance, has attempted to look back at all studies produced following the release of VIOXX (generic name Rofecoxib) to the American consumer, and to determine at which point Merck should have known of the dangerous link between cardiovascular thrombotic events and its use. The study used cumulative pooled analysis of placebo-controlled trials and reports that the was a demonstration of increased risk evinced by December 2000, with statistical significance achieved by June of 2001—or 39 months prior to when it was “voluntarily” removed from the market by Merck. In June of 2001, Rofecoxib was responsible for a measured 35% increase in cardiovascular thrombotic (CVT) events; by April of 2002 there was a 39% increase; by September of 2004 when it was pulled, there was a 43% increase. By September of 2004, investigators had identified 182 CVT adverse events in 7034 patient-years of Rofecoxib users, and only 119 CVT adverse events in 6695 patient-years of placebo users. According the authors, the FDA should probably have halted the sale of VIOXX shortly after it was approved on the market, given the information on hand at the time. This is especially true given the very marginal advantage of VIOXX over the penny-on-the-dollar alternatives available in over the counter medicines. As one author put it, the slight decrease in the risk of gastrointestinal tract bleeding only marginally benefited < 5% of the arthritis pain medication consumers at 50 times the cost—whole significantly increasing the chance of a fatal or serious heart attack. (See Invited Comments following the printed article). The full article is available online or in print. Ross, J. S., Madigan, D., Hill, K. P., Egilman, D. S., Wang, Y., Krumholz, H. M. (2009). Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. Arch Intern Med 169 (Vol. 21): 1976-1985, Nov. 23, 2009.