Merck deleted Vioxx safety info: Journal

By Ransdell Pierson

NEW YORK (Reuters) – A prestigious medical journal on
Thursday said Merck & Co. withheld information about the
dangers of arthritis drug Vioxx in a key study, an alleged
lapse that analysts said could hurt Merck as it defends itself
against Vioxx-related lawsuits.

The New England Journal of Medicine said it had determined
that Merck deleted data about three heart attacks among Vioxx
users, and other relevant data, prior to submitting its
analysis from the so-called Vigor trial to the Journal in 2000.

The trial compared the safety of Vioxx with naproxen, a
widely used rheumatoid arthritis drug.

“The evidence has raised questions about the integrity of
the data on adverse cardiovascular events in the article and
about some of the article’s conclusions,” the Journal said in a
statement on its Web site.

In response, Merck said it promptly and appropriately
disclosed the results of the study, correctly stated possible
risks of Vioxx and extensively disclosed the Vigor data to the
medical community.

Vioxx was withdrawn in September 2004 after being shown to
double the risk of heart attack and stroke in patients taking
it for over 18 months. More than 6,000 lawsuits have been filed
against Merck in the United States, alleging Vioxx caused heart
attacks and deaths.

The latest case, brought by a woman whose husband died
after taking Vioxx for less than a month, went to a federal
jury in Dallas on Thursday.

“If I was one of the attorneys suing Merck, I would be very
excited about this,” said Natexis Bleichroeder analyst Jon
LeCroy,” referring to the Journal’s allegations. “It would
imply that the company actively omitted data in a public forum,
trying to make their product look better.”

Merck shares fell 2 percent on the New York Stock Exchange
on the news and another 4.7 percent in after-hours trade.

The Journal said it had made the discovery of the alleged
deletions as part of preparations for the recent deposition of
the executive editor of the Journal in connection with
Vioxx-related litigation.

The Vigor study appeared in the Journal in November 2000,
soon after Vioxx was launched in the United States to great
fanfare as a painkiller that is much gentler on the stomach
than conventional treatments like aspirin and naproxen.

The Journal said Merck had submitted its manuscript both on
paper and on a computer diskette, but that the Journal’s
pre-publication review and editing of the story were completely
on the printed version of the manuscript.

The Journal said it did not review the diskette until
October 2004, several days after Vioxx was withdrawn.

“In reviewing the diskette, we learned that data on
cardiovascular events had been deleted from the manuscript
before it was submitted,” the Journal said.

Three heart attacks among the Vioxx group were not included
in the printed manuscript, the Journal said.

It said a memorandum dated July 5, 2000 recently made
available to the Journal indicates at least two authors of the
Vigor manuscript knew about the unmentioned heart attacks at
least two weeks before they submitted the first of two
revisions to the manuscript and 4-1/2 months before the article
was published.

The additional heart attacks became known after the
publication’s “cutoff” date for data to be analyzed and were
therefore not reported in the Journal article, Merck said.

Instead, Merck said it reported them to U.S. regulators in
2000 and included them in subsequent press releases.

“We also note that these additional events did not
materially change any of the conclusions of the article,” Merck
said in its statement.

The Journal, however, contended the omissions of the
additional heart attacks resulted in an “understatement” of the
heart risks of Vioxx, and asked that the authors of the study
“submit a correction to the Journal.”

Even without inclusion of those three heart attacks, the
Vigor article showed that rheumatoid arthritis patients taking
Vioxx had about five times the incidence of heart attacks as
those taking naproxen.

Merck later defended the heart-safety of Vioxx, theorizing
that Vioxx had done no harm but that naproxen had somehow
protected patients from heart attacks.

Vioxx remained on the market and generated annual sales of
$2.5 billion by 2003, bolstered by splashy Merck ads.

A New Jersey jury just last month found Vioxx was not
responsible for the heart attack in a postal worker who had
taken the drug for two months.

However, a Texas widow won the first case against the
company when a jury ruled in August the company was at fault in
the death of her husband. That jury awarded her $253 million in
compensatory and punitive damages, although that amount is
likely to be trimmed to about $26 million because of Texas
limitations on damage awards.

Merck stock fell to $28.87 on the Inet electronic brokerage
from a close of $29.68 on the New York Stock Exchange.

(Additional reporting by Lewis Krauskopf and Edward Tobin,
and Gene Emery in Boston)