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Big HMO Reconsiders Vioxx After Study Points to Heart Risks
Big HMO Reconsiders Vioxx After Study Points to Heart Risks -- Posted by MrPepper11 on 08-26-04 10:10
August 26, 2004
Big HMO Reconsiders Vioxx After Study Points to Heart Risks
By ANNA WILDE MATHEWS and SCOTT HENSLEY
Staff Reporters of THE WALL STREET JOURNAL
One of the nation's biggest health-maintenance organizations is
reconsidering its use of the blockbuster arthritis medicine Vioxx
after a major study based on data from its patients found that the
Merck & Co. drug may increase the risk of serious heart problems.
The study, led by a Food and Drug Administration researcher, adds to
the mounting safety questions surrounding Vioxx and is expected to
boost its biggest rival, Pfizer Inc.'s Celebrex.
Physician committees from the HMO, Kaiser Permanente, which has more
than eight million members, will decide in the next few weeks how it
will deal with the latest findings on Vioxx, which costs about $3 a
day.
Vioxx had U.S. sales last year of about $2 billion, compared with
about $2.8 billion for Celebrex, according to data from health-care
information company NDCHealth, Atlanta.
The report found that higher doses of Vioxx appeared to triple
patients' risk of a heart attack or sudden cardiac death, when
compared with the results for people who hadn't recently taken any
similar drug. Even at lower doses, Vioxx appeared to have a stronger
association with the heart problems than Celebrex.
The study was initiated by the FDA and funded by an agency contract
with Kaiser Permanente. Kaiser contributed resources, including
programming, technical and clinical support. The lead author of the
study, David Graham, is a medical officer in the FDA's Office of Drug
Safety. But as is typical for research performed by FDA staffers, the
study has a disclaimer indicating that it doesn't reflect the official
views of the agency.
The study's results carry added weight because it's based on a large
group of patients and follows studies dating as far back as 2001 that
have signaled a link between Vioxx and heart risks.
As physician committees from Kaiser Permanente weigh their response to
the findings, options include halting prescriptions of high doses of
Vioxx or stopping use of the drug altogether by members, said David
Campen, the Oakland, Calif., HMO's medical director of drug
information, utilization and technology and a co-author of the study.
"From a cardiovascular perspective, Celebrex and all other
nonsteroidals are safer than Vioxx," said Dr. Campen, who is also a
rheumatologist, or specialist in joint diseases. "We're going to take
a serious look at the status of this product and its use in our
members in light of these findings." Celebrex also costs about $3 a
day.
Mary Elizabeth Blake, a Merck spokeswoman, said the company "disagrees
with the conclusion" of the study. She added that randomized trials
comparing Vioxx with a placebo, including two that treated thousands
of elderly patients, showed no significant difference in the rate of
serious cardiovascular events in patients taking Vioxx. She said such
trials are more authoritative than the new study and similar analyses
based on observations of a population after treatment with a variety
of medicines, which have inherent limitations that contribute to
inconsistent results.
The FDA's Dr. Graham defends the study's findings and significance. It
"had the statistical power to see these differences" between drugs, he
said, adding that the study was "extremely large" and "carefully
done."
Among doctors and patients, the new study is likely to underscore
concerns about Vioxx, known generically as rofecoxib, and bolster use
of other drugs such as Celebrex, or celecoxib.
"It certainly casts doubt on the safety of high doses of rofecoxib,"
said John Klippel, chief executive of the nonprofit Arthritis
Foundation. The growing research "certainly questions whether they
should be used at all." He added that in general, if a patient was at
risk for heart problems, the growing evidence of a difference between
Celebrex and Vioxx "would lead one to prescribe celecoxib instead of
rofecoxib."
The findings, even though they come in a study by an FDA drug-safety
staffer, may increase pressure on the agency and Merck to consider
stronger warning language for Vioxx's label. Currently, the label says
under the "precautions" section that "caution should be exercised when
Vioxx is used in patients" with a history of heart disease, and offers
data about the issue.
Vioxx, which came out in 1999, has been one of Merck's top products as
the company has struggled recently to find new breakthrough
treatments. Besides osteoarthritis and rheumatoid arthritis, it is
approved to treat conditions including acute pain and migraines. It is
a Cox-2 inhibitor, a type of medicine that is supposed to carry fewer
gastrointestinal problems than older painkillers in the category of
nonsteroidal anti-inflammatory drugs, or NSAIDS. Merck has promoted
Vioxx as creating fewer gastrointestinal problems than older drugs.
Merck's share of the $6 billion U.S. market for Cox-2 drugs slipped to
32% last month from 43% in 2001, when the concerns about
cardiovascular risks for Vioxx surfaced, according to data from
NDCHealth. Vioxx's woes have been good for Pfizer, which makes
competing Cox-2 medicines Celebrex and Bextra, or valdecoxib.
"We feel that for Celebrex this is excellent news," said Gail
Cawkwell, Pfizer's world-wide medical director for Celebrex. She said
the study "is a good reflection of reality" because it looks at the
experience of large numbers of patients being treated in routine
clinical practice.
Novartis AG also has a potential rival waiting in the wings, its
unapproved arthritis drug Prexige. In a study recently published in
the medical journal the Lancet, researchers compared Prexige to older
pain medications, and found it reduced pain without an increase in the
rate of serious cardiovascular problems. Novartis has said it hopes to
file for U.S. approval by 2006.
The new study is only the latest to point to a possible heart risk
tied to Vioxx. In a paper published this May in Circulation, the
journal of the American Heart Association, researchers from a
Harvard-affiliated hospital examined records from 54,475 Medicare
patients. The study found that Vioxx use was "associated with an
elevated relative risk" of heart attacks compared to use of Celebrex
or no similar painkiller. That finding followed a high-profile article
published in 2001 in the Journal of the American Medical Association,
which pointed to similar possible risks.
The new results add to "a series of compelling and extremely worrisome
points of evidence about the rofecoxib danger," says Eric Topol,
chairman of cardiovascular medicine at the Cleveland Clinic, who was
an author of the 2001 analysis. "At the very least, I believe the FDA
should put out a major warning regarding rofecoxib at doses greater
than 25 mg."
The study was unveiled yesterday at a conference of the International
Society for Pharmacoepidemiology in Bordeaux, France. It drew on data
from about 1.4 million Kaiser patients who had taken one of the
NSAIDs. That included 40,405 who had taken Celebrex and 26,748 who had
taken Vioxx.
The study focused on the risk of heart attacks and sudden cardiac
deaths, and it compared patients who had taken the drugs with patients
who hadn't taken any NSAID for at least 60 days. By that comparison,
patients who had taken doses of Vioxx higher than 25 milligrams a day
were 3.15 times as likely to have a heart problem. The result reached
statistical significance, though it was based on just 10 cases of
serious heart problems in patients who took high doses of Vioxx. The
authors wrote that their findings and other research "cast serious
doubt on the safety" of the higher doses of Vioxx.
For lower doses of Vioxx, the heart problems were 1.29 times as likely
as for the people who hadn't taken NSAIDS recently, but this result
wasn't strong enough to achieve statistical significance. But the
ratio was higher than those for any of the other painkillers examined
-- though some of these also weren't statistically significant -- and
for the category of all recent NSAID use lumped together. There were
58 cases of heart attacks or sudden cardiac death among patients
taking the lower doses of Vioxx.
Patients who took Celebrex were 14% less likely than those who hadn't
recently taken the painkillers to have heart problems, though this
benefit also didn't achieve statistical significance. There were 126
heart attacks or sudden cardiac deaths among those taking Celebrex.
The difference between the risk levels for Vioxx and Celebrex was big
enough so that it did reach statistical significance, and the study's
authors concluded that Celebrex "may be safer" than Vioxx from a
cardiovascular perspective. Still, the finding is a "suggestion, and
not a conclusion," says Curt Furberg, a professor at Wake Forest
University School of Medicine who examined the findings.
======================================================
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