Staid NEJM gets political on eve of COX-2 hearings

The New England Journal of Medicine in this week's edition will publish three studies questioning the safety of all COX-2 inhibitors, not just Merck's Vioxx. It also early released a hard-hitting editorial. The Food and Drug Administration advisory committee considering the safety of COX-2 painkillers like Vioxx opens hearings Wednesday morning, and the nation's leading medical journal left no doubt where it stands.

"When (early) clinical trials showed an increased risk of myocardial infarction (that's the medical terminology for a heart attack), rather than consider this finding a major danger signal, the manufacturers designed trials to show efficacy for other indications and enhanced the cardiovascular safety monitoring in these subsequent trials. . . Had trials designed to test the question of cardiovascular toxicity directly been launched in 1999 and executed with urgency, substantial morbidity and perhaps a substantial number of deaths could have been prevented."

The NEJM might have pointed out that though the Merck trial that showed an increased risk of heart attacks was eventually published in its own pages in November 2000, it wasn't until nearly a year later and in the pages of the rival Journal of the American Medical Association that cardiologists at the Cleveland Clinic raised the alarm bells. The FDA wasn't the only institution slow to react to the mounting evidence against the COX-2s.