Merck Fires Back at Medical Journal

The top editors of the New England Journal of Medicine resumed their criticism of a study, sponsored by Merck (MRK), on the arthritis drug Vioxx, repeating that the November 2000 article should be corrected.

Officials from Merck and other authors of the article responded in separate letters to the JournalWednesday, saying their manuscript followed proper standards of research and presentation.

"Our original article followed appropriate clinical trial principles and does not require a correction," says the response of the non-Merck researchers, including Dr. Claire Bombardier, of the University Health Network, who was the lead author for the clinical trial, known as VIGOR.

The Journal's editors reiterated their "expression of concern" that was issued in December. They said the VIGOR article was based on an "untenable" trial design, "which inevitably skewed the results." They said the article "did not accurately reflect the potential for serious cardiovascular toxicity" with Vioxx.

The latest fight between editors and authors is contained in an online release of letters for an upcoming issue of the Journal. The editors' criticism that some data was withheld from publication is being used by plaintiffs' lawyers to press their case against Merck. As of Dec. 31, Merck was the defendant in 9,650 U.S. personal- injury suits and 190 class-action suits alleging personal injuries or economic losses. Merck has won two cases, and the company is appealing the one case that it lost.

Merck withdrew Vioxx from the market in September 2004 after being informed by an independent safety monitoring committee that another clinical trial, known as APPROVE, had detected a higher cardiovascular risk among patients taking Vioxx vs. those taking a placebo after 18 months. APPROVE was testing whether Vioxx could treat colon polyps.

The VIGOR trial wasn't looking for heart risks, but was designed to assess if Vioxx caused fewer gastrointestinal side effects than an older pain reliever, naproxen. VIGOR found that both drugs were equally effective and that Vioxx caused fewer gastrointestinal problems, a key issue for people taking pain relievers, especially the elderly.