Merck Knew Vioxx Was Unsafe by 2000 - Report

Nov 15, 2004 - WASHINGTON (Reuters) - Pharmaceutical giant Merck & Co
Inc. had evidence by 2000 that its painkiller Vioxx, which was pulled
off the market on Sept. 30, was not safe, a heart specialist told CBS
News program "60 Minutes" on Sunday.

Dr. Eric Topol, chief of cardiovascular medicine at the Cleveland
Clinic, examined all available data about Vioxx and other similar
pain relief medications in 2001 for a study published in the Journal
of the American Medical Association.

Topol said the company conducted its biggest clinical trial of the
drug, widely known as the "Vigor" study, in 1999, which found that
Vioxx users had nearly a fivefold increase in heart attacks.

Topol, a well-known cardiovascular researcher, also reviewed an
unpublished clinical trial of Vioxx by Merck in 1998 that showed
patients who took the drug were six times more likely to have serious
cardiovascular events - including heart attacks and strokes - than
patients who took another arthritis drug or placebo.

Topol told "60 Minutes" that the two studies showed Vioxx was not

"You've got two trials now. You have essentially lightning striking
twice. That's independent replication, that's really serious
confirmation," Topol said. "This is unequivocal, this is a serious

Topol's remarks come amid major legal challenges to Merck over Vioxx,
fueled in part by class-action lawyers seeking to prove that the
drugmaker knew about Vioxx risks but ignored the evidence.

As of Oct. 31, Merck said it has been served or is aware that it has
been named as a defendant in about 375 lawsuits, which include some
1,000 plaintiff groups alleging personal injuries resulting from the
use of Vioxx.

Merck, which disputes Topol's findings, told "60 Minutes" the 1998
study was too small and not statistically significant enough to be
able to draw any conclusions.

In March 2000, results from a clinical trial known as the "Approve"
study showed Vioxx doubled the risk of heart attack and strokes in
patients who had taken it for over 18 months to prevent recurrence of
colon polyps. Merck recalled the drug on Sept. 30 based on data from
the trial.

Merck told "60 Minutes" that study provided the first clear evidence
that Vioxx was linked to heart attacks and strokes.

Merck executives have said the company acted responsibly by
voluntarily withdrawing Vioxx as soon as it had clear evidence the
drug was harmful.

About 105 million U.S. prescriptions were written for Vioxx from May
1999 through August 2004, and about 20 million people have used the
drug since its 1999 launch, Merck said.

Merck has been subpoenaed by the U.S. Justice Department and the
Securities and Exchange Commission has started an informal inquiry
concerning the pharmaceutical giant's recalled pain reliever Vioxx.

In an SEC filing, Merck said that it is cooperating with both probes.

Shares of the New Jersey-based drugmaker closed at $26.45 in Friday
trading on the New York Stock Exchange.