[PHNUTR-L] New England Journal Editors Find They Were Hoodwinked on Vioxx Study

[Kathrynne Holden, MS, RD]

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New England Journal Editors Find They Were Hoodwinked on Vioxx Study
http://www.medpagetoday.com/ProductAlert/Prescriptions/tb/2291		
   	
By Peggy Peck, Managing Editor, MedPage Today
December 08, 2005

Also covered by: Boston Globe, CNN, Houston Chronicle

BOSTON, Dec. 8 - Chagrined editors of the New England Journal of 
Medicine said today they just discovered that the authors of a Vioxx 
(rofecoxib) study published five years ago omitted data, some at the 
last minute, that would have linked the painkiller to a greater relative 
risk of heart attacks.

In an extraordinary statement from the NEJM editors, they wrote that 
Claire Bombardier, M.D., a Toronto rheumatologist, and her 
co-investigators omitted information about three myocardial infarctions 
that occurred among patients randomized to Vioxx.

The original Vioxx Gastrointestinal Outcomes Research (VIGOR) study, 
which was published November 23, 2000, reported 17 MIs in the Vioxx arm 
and 4 in the naproxen arm, for a relative risk of 4.25. The actual 
events are 20 MIs in the Vioxx arm versus four in the naproxen arm for a 
relative risk of 5.0.

The NEJM editors wrote that until a few weeks ago, they believed that 
Dr. Bombardier and colleagues were unaware of "these late events." Now, 
however, the editors said they have evidence that the a memo written 
July 5, 2000, indicates that "at lease two of the authors knew about the 
three additional myocardial infarctions at least two weeks before the 
authors submitted the first of two revisions and 4.5 months before the 
publication of the article."

Moreover, the editors wrote that they have "determined from a computer 
diskette that some of these data were deleted from the VIGOR manuscript 
two days before it was submitted to the Journal on May 28, 2000."

The journal editors say they have asked Dr. Bombardier and colleagues to 
submit a correction.

The NEJM editors claim the information came to light three weeks ago 
when NEJM executive editor Gregory D. Curfman, M.D., was deposed on Nov. 
21 as part of the ongoing Vioxx litigation in which hundreds of 
plaintiffs are suing Merck, the maker of Vioxx.

Merck, which had vigorously defended the safety of Vioxx for years, 
abruptly pulled the drug from the market on Sept. 30, 2004, when the 
data safety monitoring board of a colon-polyp prevention trial reported 
that long term Vioxx use was associated with an increased risk of 
cardiovascular events.

The editors released the new statement online today. Tagged "a form al 
Expression of Concern" the NEJM said its publication follows a procedure 
hammered out by the International Committee of Medical Journal Editors 
for announcing that the validity of a published work is uncertain.
-- 
Kathrynne Holden, MS, RD < fivestar at nutritionucanlivewith.com >
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