Lawmaker Alleges Merck Censored Vioxx Safety Concerns

A promotional card that Merck's sales force used to tout the safety profile of Vioxx to doctors was "inaccurate and misleading" and did not reflect just-released findings from a major clinical study that linked the drug to increased cardiovascular risks, according to a prominent House Democrat.

Merck's VIGOR study, published in March 2000, determined that the arthritis pain drug Vioxx (rofecoxib) had five times the cardiovascular risks of the nonsteroidal anti-inflammatory drug naproxen. After that study was concluded, however, Merck directed its 3,000-member sales force to show physicians a "Cardiovascular Card" that made it appear Vioxx could be eight to 11 times safer than other anti-inflammatory drugs, said Rep. Henry Waxman (D-Calif.), the ranking Democrat on the House Government Reform Committee.

"Instead of informing doctors about the risks of Vioxx, Merck told its representatives to continue to rely on the highly questionable Cardiovascular Card," Waxman said during a recent committee hearing on the role of the FDA and drugmakers in ensuring the safety of drugs like Vioxx.

Waxman based his conclusions on an analysis of thousands of pages of documents obtained from Merck, including the Cardiovascular Card. The tri-fold pamphlet stated patients taking Vioxx were 11 times less likely to die and eight times less likely to die from heart attacks and strokes than patients taking standard anti-inflammatory drugs. The data presented in the card appears to have little or no scientific validity, and did not contain data from the VIGOR study, Waxman said. "Instead, the card presented pooled data from clinical trials conducted prior to the drug's approval in osteoarthritis patients," he noted.