How the New England Journal Missed Warning Signs on Vioxx

Vioxx

In August 2001, a Seattle pharmacist called a radio show on which Jeffrey Drazen, the top editor of the New England Journal of Medicine, was appearing. On the air, the pharmacist, Jennifer Hrachovec, begged Dr. Drazen to update an article in the journal that touted the benefits of the painkiller Vioxx while playing down its heart risks.

Dr. Hrachovec had been reviewing data on a Food and Drug Administration Web site indicating that patients in a Vioxx clinical trial had suffered more heart attacks than the journal article about the trial reported. “It bothers me there is more data from the trial than has ever been published and the New England Journal still hasn’t published an editorial or any kind of update,” she said. “My concern is that doctors are still using this and exposing their patients to higher risks of heart problems and they just don’t even know that that’s the case.”

Vioxx may trigger heart attacks within days

Vioxx

The controversial painkiller Vioxx (rofecoxib) may cause heart attacks within just two weeks of starting the drug treatment, a study of Canadian patients claims.

The finding could influence the outcome of the many thousands of lawsuits filed against Vioxx manufacturer Merck, because it suggests that the once-popular arthritis drug could have contributed to a heart attack or stroke even among patients who took it for very brief periods.

Vioxx was pulled from the market in 2004 after a large clinical trial showed that taking the drug for 18 months nearly doubles the risk of heart attack and stroke1. There has been intense medical and legal debate about whether these problems actually kick in much earlier.

Linda Lévesque of McGill University in Montreal, Canada, and her colleagues tackled this question by scouring the computerized health records of 125,000 Quebec residents aged 66 or older. They identified people who had taken Vioxx and the related drug Celebrex (celecoxib), and examined the frequency and time at which these people suffered heart attacks.