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WASHINGTON -- A study led by a Food and Drug Administration safety
official projects that the widespread use of Vioxx may have led to more
than 27,000 heart attacks and sudden cardiac deaths before the drug's
abrupt withdrawal last week by Merck & Co. (MRK), Wednesday's Wall Street Journal reported.
The number is in comparison to how many similar incidents would have
occurred had the same patients been taking Celebrex, the Pfizer Inc. drug
that competed with Merck's blockbuster arthritis treatment. The analysis
specifically found that from Vioxx's approval in 1999, through 2003, an
estimated 27,785 heart attacks and sudden cardiac deaths "would have been
avoided" had Celebrex been used instead of Vioxx.
Those figures don't come from actual counts, but are projections based
on findings from an analysis of a database of patients of Kaiser
Permanente, the big health-maintenance organization.
Some of the paper's conclusions emerged in August, when it was
presented at a medical conference. But the complete version, dated
Sept. 30, goes farther on the possible impact of the
painkiller, which was taken by approximately 20 million Americans before
being withdrawn from the market last week.
In providing its potential estimate of the adverse impact, the study is
a new headache for Merck, which is facing a flood of lawsuits that will
question whether the company should have taken stronger action sooner in
response to concerns about Vioxx.
Merck quickly withdrew the drug after a clinical trial found that
people taking a low dose of Vioxx for more
than 18 months were twice as likely to have a heart
attack or stroke as those taking a placebo. Earlier research had suggested
a possible link between the drug and cardiovascular problems.
A Merck spokesman said in a statement that the company "cannot comment
on the full study, as we have not yet had the opportunity to review
it."
The study led by the FDA researcher hasn't been released, but a copy
has been requested by Senate Finance Committee Chairman Charles
Grassley, an Iowa Republican, who is investigating how FDA
handles safety concerns. Its lead author, David Graham,
is associate director for science in the FDA drug center's office of drug
safety. Other authors are from Kaiser and Vanderbilt University. The study
was initiated by the FDA and funded by an agency contract with Kaiser,
which contributed some support.
Steven Galson, acting director of the FDA's drug
center, said he first saw the study Tuesday and that it is "too early to
say" whether the agency agrees.
Wall Street Journal Staff Reporter Anna Wilde Mathews
contributed to this report.
Dow Jones Newswires
10-06-04 0443ET Copyright (C) 2004 Dow Jones
& Company, Inc. All Rights Reserved.
