Medical Journal Questions Merck's Vioxx Data

Updated from 5:02 p.m. EST

The New England Journal of Medicine on Thursday asked authors of a clinical study sponsored by Merck (MRK Quote) to make corrections to an article on Vioxx that was published five years ago, suggesting that information was withheld.

The Journal, in an editorial, said "inaccuracies and deletions" that it now knows about "call into question the integrity of the data" on the drug's links to heart-related problems.

Merck responded that it only recently learned about the editorial and hasn't had time to prepare a formal response, but the Whitehouse Station, N.J., drugmaker said it "promptly and appropriately disclosed the results" of the test, known as VIGOR, that was cited by the Journal.

The company said it "correctly communicated about the benefits and possible risks" of its arthritis drug and "extensively disclosed the VIGOR data to the scientific and medical communities, and in the press."

Merck withdrew Vioxx from the market on Sept. 30, 2004, citing another company-sponsored study called APPROVE. This study said patients taking Vioxx for more than 18 months had a greater risk of heart-related problems than did patients receiving a placebo.

The Journal editorial was published online Thursday afternoon before the market had closed. Merck's stock lost 61 cents, or 2%, to $29.68 in regular trading. After hours, the stock fell another 79 cents, or 2.7%.

As of the end of this past September, more than 6,400 lawsuits had been filed in the U.S. alleging Vioxx caused injury or death. Merck lost one case in a Texas state court in August, then it won a case last month in a New Jersey state court. Merck says it will appeal the Texas verdict. A jury in Houston has now started deliberating in the first federal court trial.

The VIGOR clinical trial compared whether patients taking Vioxx had fewer gastrointestinal problems than patients taking an older pain reliever, naproxen. Stomach distress is a significant side effect in people taking arthritis drugs, especially the elderly. The study said Vioxx caused fewer gastrointestinal side effects and that both drugs were equally effective in pain relief.