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Was Vioxx Data Hidden?

Merck Study May Have Hidden Vioxx Data
Matthew Herper and Robert Langreth, 12.08.05, 3:17 PM ET

In the wake of a court deposition of one of its top editors, The New England Journal of Medicine says that data that might have linked the drug to an increase in heart attacks years earlier was deleted from the biggest study of Merck's (nyse: MRK - news - people ) Vioxx, published in 2000.

The Journal has asked the authors for a correction.

According to a posting on the Journal's Web site, editors at the world's top medical journal found by examining a computer diskette that relevant data about Vioxx's risk to the heart compared with an older pain drug, naproxen, were deleted two days before the paper was initially submitted to the Journal.

In a statement, NEJM editors said, "During this process, we learned that relevant data on cardiovascular outcomes had been deleted from the VIGOR manuscript prior to its submission to the Journal and that the authors had withheld data on other relevant cardiovascular outcomes.

"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 discovery stems from a court deposition of Gregory Curfman, one of the Journal's top editors. Reached at home earlier this week, Curfman said that the Journal was "in the process of trying to formulate a response to the entire Vioxx situation. I am trying to take a fresh look of the process we went through. I have gone through each and every version of the VIGOR manuscript carefully, and we will have something to say" in the near future. The review started after he began looking over old papers in preparation for his November deposition by plaintiffs' lawyers.

A New England Journal of Medicine spokeswoman said, "As a general rule...it would be of great concern to us if the authors of a research manuscript failed to report relevant data during either the submission or editing process."

Claire Bombardier, the lead author of the manuscript, did not return repeated calls for comment earlier this week. Merck was not immediately available for comment.


Last Updated ( Dec 09, 2005 at 11:59 PM )