Report: Merck knew
Vioxx unsafe in 2000
Pharmaceutical
giant Merck & Co Inc. had evidence by 2000 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.
Merck
disputes Topol's findings.
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unpublished clinical trial of Vioxx by Merck in 1998 that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 safe.
"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 problem."
Merck
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.
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 October 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.
About
105 million
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.