Study Authors Defend Their Research But NEJM Editors Are Not Convinced
   

In the March 16, 2006 edition of The New England Journal of Medicine (NEJM) are two letters by authors of the now infamous Vioxx Gastrointestinal Outcomes (VIGOR) study article that was published by the NEJM in 2000.  The letters are intended to reinforce the integrity of their VIGOR research.  In the same edition, however, is an editorial by Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. which is essentially a reaffirmation of the NEJM editors’ December 2005 "Expression of Concern".

Thus continues the controversy between Merck and the NEJM about the timing of Merck’s disclosure of cardiovascular events linked to Vioxx that occurred in the VIGOR study but were not part of the original VIGOR study article published by the NEJM in 2000.

The first letter to the editor in support of the VIGOR study is written by Claire Bombardier, M.D., who was a lead author of the VIGOR study, and ten of her colleagues who are not Merck employees.  Dr. Bombardier and her colleagues contend that they did not deliberately omit from the VIGOR study article data concerning three additional heart attacks that occurred in the Vioxx treatment group.  Dr. Bombardier and colleagues state that, based on their review of the VIGOR data after the December 2005 "Expression of Concern" was published in by the NEJM, "our original article followed appropriate clinical trial principles and does not require a correction."

This is followed by the second letter to the editor, which was written by two researchers involved with the VIGOR study who are Merck employees, Alise Reicin, M.D., and Deborah Shapiro Dr.P.H.  They defend the original VIGOR study article, also, emphasizing the propriety of scientific analysis and presentation of data, as well as Merck’s prompt disclosure of the three additional heart attacks that occurred in the Vioxx treatment group to the FDA.

The NEJM editors replied to these two letters by means of a new editorial about Merck and Vioxx, wherein they indicated that the explanations offered by the VIGOR researchers may have been technically correct but were essentially disingenuous. Fundamentally, the NEJM editors allege that the conclusions in the original Vioxx study article did not reflect a spirit of efficacy and safety.

As background, VIGOR was a double-blind, randomized outcomes study of upper gastrointestinal events that involved 8,000 arthritis patients taking either 50 mg of Vioxx 50mg or naproxen 500mg twice a day.  Vioxx is a COX-2 inhibitor.

Merck withdrew Vioxx from the market in September 2004 after it released data from another Vioxx study which suggested that Vioxx increased the risk of having a heart attack or stroke in patients who had taken Vioxx daily for 18 months or longer.

(Posted by: Tom Lamb)