Medical journal says Merck deleted Vioxx dangers

A prestigious medical journal on Thursday said Merck & Co. withheld information about the dangers of arthritis drug Vioxx in a key study, an alleged lapse that analysts said could hurt Merck as it defends itself against Vioxx-related lawsuits.

The New England Journal of Medicine said it had determined that Merck deleted data about three heart attacks among Vioxx users, and other relevant data, prior to submitting its analysis from the so-called Vigor trial to the Journal in 2000.

The trial compared the safety of Vioxx with naproxen, a widely used rheumatoid arthritis drug.

"The evidence has raised questions about the integrity of the data on adverse cardiovascular events in the article and about some of the article's conclusions," the Journal said in a statement on its Web site.

In response, Merck said it promptly and appropriately disclosed the results of the study, correctly stated possible risks of Vioxx and extensively disclosed the Vigor data to the medical community.

Vioxx was withdrawn in September 2004 after being shown to double the risk of heart attack and stroke in patients taking it for over 18 months. More than 6,000 lawsuits have been filed against Merck in the United States, alleging Vioxx caused heart attacks and deaths.

The latest case, brought by a woman whose husband died after taking Vioxx for less than a month, went to a federal jury in Dallas on Thursday.

"If I was one of the attorneys suing Merck, I would be very excited about this," said Natexis Bleichroeder analyst Jon LeCroy," referring to the Journal's allegations. "It would imply that the company actively omitted data in a public forum, trying to make their product look better."

Merck shares fell 2 percent on the New York Stock Exchange on the news and another 4.7 percent in after-hours trade.

The Journal said it had made the discovery of the alleged deletions as part of preparations for the recent deposition of the executive editor of the Journal in connection with Vioxx-related litigation.

The Vigor study appeared in the Journal in November 2000, soon after Vioxx was launched in the United States to great fanfare as a painkiller that is much gentler on the stomach than conventional treatments like aspirin and naproxen.

The Journal said Merck had submitted its manuscript both on paper and on a computer diskette, but that the Journal's pre-publication review and editing of the story were completely on the printed version of the manuscript.

The Journal said it did not review the diskette until October 2004, several days after Vioxx was withdrawn.

"In reviewing the diskette, we learned that data on cardiovascular events had been deleted from the manuscript before it was submitted," the Journal said.