NEWS - Vioxx study accurate, authors say; NEJM editors disagree

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Vioxx Study Accurate, Authors Say; Editors Disagree (Update1)

Feb. 22 (Bloomberg) -- The authors of a disputed study on Merck &

Co.'s withdrawn Vioxx pain pill and the editors of the medical journal that

published it disagreed on the study's accuracy in letters released by the

publication today.

The researchers, led by Bombardier from the University Health

Network in Toronto, rejected a Dec. 8 request from editors of the New

England Journal of Medicine to correct the report it published in 2000. The

journal editors reaffirmed their concern that the study was " misleading''

because it left out three cases of heart attacks, skewing the findings.

The study did not " contain relevant safety data available to the

authors more than four months before publication,'' the editors wrote today.

As a result, it " did not accurately reflect the potential for serious

cardiovascular toxicity. We therefore reaffirm our expression of concern.''

The letters were posted on the journal's web site and will appear in

print in the March 16 issue. The study, referred to by the term VIGOR,

compared the safety of Vioxx with another prescription painkiller called

naproxen.

Merck, the No. 3 U.S. drugmaker, withdrew Vioxx in 2004 when a study

found it doubled the risk of heart attacks after 18 months. Merck shares

rose 53 cents, or 1.5 percent, to $36.12 at 12:59 p.m. in New York Stock

Exchange composite trading.

The letter from the researchers didn't include the authors who work

for Whitehouse Station, New Jersey-based Merck.

'Stand By Article'

The study didn't include the three heart attacks among patients taking

Vioxx, and one stroke in a patient on naproxen, because they occurred after

the cutoff date for reporting cardiovascular problems, the researchers said.

Adding those events wouldn't have changed the results, they said.

" We stand by our original article, which was written in line with

basic clinical trial principles,'' the researchers wrote today.

" Cardiovascular events were not deleted from the manuscript, and there is no

material difference in the conclusions that arise from the addition of the

events'' that occurred after the study stopped.

In a separate letter, signed by doctors who work for Merck, the

company said, " We stand behind the propriety of the scientific analysis and

presentation of data in the paper, as well as Merck's prompt disclosure'' of

all data to the U.S. Food and Drug Administration and the medical community.

In November, a jury in Atlantic City, New Jersey, rejected claims that

Vioxx caused an Idaho postal worker's heart attack in 2001. He had used the

drug for about two months. Merck adequately warned doctors about the risks

and didn't defraud consumers, the jurors said.

The company is defending itself in a third state trial under way in

Texas. Six more cases are set for trial in state courts in New Jersey,

Texas, Florida and California in the next six months.

Last Updated: February 22, 2006 13:36 EST

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