[PHNUTR-L] New England Journal Editors Find They Were Hoodwinked on
Kathrynne Holden, MS, RD
fivestar at nutritionucanlivewith.com
Fri Dec 9 07:04:19 PST 2005
Colleagues, the following is FYI and does not necessarily reflect my own
opinion. I have no further knowledge of the topic. If you do not wish to
receive these posts, set your email filter to filter out any messages
coming from @nutritionucanlivewith.com and the program will remove
anything coming from me.
New England Journal Editors Find They Were Hoodwinked on Vioxx Study
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
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 >
"Ask the Parkinson Dietitian" http://www.parkinson.org/
"Eat well, stay well with Parkinson's disease"
"Parkinson's disease: Guidelines for Medical Nutrition Therapy"
More information about the PHNUTR-L