November 2000 NEJM article about VIGOR trial left out heart attack data.

Merck Concealed

NEJM (The New England Journal of Medicine) has dropped a bombshell in an editorial, Expression of Concern, written by Jeffrey M. Drazen, M.D. (the journal's editor-in-chief), George D. Curfman, M.D. (executive editor), and Stephen Morrissey, Ph.D. It is alleged in the editorial that Merck & Co., the maker of Vioxx, withheld data and information that would affect conclusions drawn in the manuscript about the VIGOR (Vioxx Gastrointestinal Outcomes Research) study which appeared in the New England Journal of Medicine on November 23, 2000.

The VIGOR study compared gastrointestinal events in rheumatoid arthritis patients who were randomly assigned Vioxx or naproxen. Cardiovascular events were also monitored during the study. Three myocardial infarctions (heart attacks) which occurred in the Vioxx group were not included in data submitted for the NEJM article.

NEJM Editors Didn't Think Information Was Intentionally Concealed

NEJM editors learned about the myocardial infarctions in 2001 from updated information made public by the U.S. Food and Drug Administration (FDA). NEJM editors believed the information about myocardial infarctions which occurred in the Vioxx group during the VIGOR trial was learned too late to be included in the November 23, 2000 article published in NEJM.

However, a memorandum dated July 5, 2000 which surfaced following subpoena during the ongoing Vioxx litigation has revealed new information. At least two authors of the November 23, 2000 article knew about the myocardial infarctions before the manuscript was submitted to NEJM and 4 1/2 months before publication of the article.

The Discrepancy Which Revealed The Omission

Merck had submitted the manuscript for the November 23, 2000 article about the VIGOR trial on paper and also on a computer diskette. Editing of the manuscript was based solely on the print version. NEJM did not review the computer diskette until October 5, 2004, just days after Merck pulled Vioxx from the market. The review of the computer diskette revealed that information about the three myocardial infarctions was not included in the print manuscript.

Drazen, Curfman, and Morrissey claim in their editorial that by concealing the information about the myocardial infarctions, conclusions were drawn in the published article which were inaccurate.

Back In Merck's Court

Authors of the VIGOR article have reportedly been asked to submit a correction to NEJM. A response to the allegations is expected from Merck. Meanwhile, Merck continues to battle in court over its liability in more than 7,000 lawsuits. The legal liability which some analysts estimate to be about $50 billion caused Merck to announce the termination of 7,000 jobs and closing of eight research and production facilities just last week.