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Merck
decided to pull the drug, touted as a pain reliever that's easy on
the stomach, following a trial that indicated risk of heart
attacks and strokes after taking it for 18 months.
Doctors
say that switching to Pfizer Inc.'s Celebrex or Bextra may be a
good option for people who are at risk for stomach problems and
thus may not be good candidates for the cheaper generic
painkillers. While Celebrex, like Vioxx, belongs to a class of
drugs known as COX-2 inhibitors, the Pfizer drug to date has not
been found to have the same level of cardiac risk as Vioxx.
"Some
people will lump them together, but I don't think that's
right," says Daniel Solomon, a rheumatologist at Brigham and
Women's Hospital, Boston. "There is no data that Celebrex is
associated with risk."
Not
everyone agrees: The European Agency for the Evaluation of
Medicinal Products considers the whole COX-2 class of drugs to
have the increased cardiac risk. It says people at risk for heart
disease shouldn't take them. Eric Topol, chairman of
cardiovascular medicine at the Cleveland Clinic says there haven't
been rigorous studies of any of the COX-2 drugs looking
specifically at their impact on heart risk.
The
Food and Drug Administration has also said it is going to
re-examine the data on the other COX-2 drugs.
Those
Vioxx patients without stomach problems will likely be better off
going back to over-the-counter pain relievers such as ibuprofen
and naproxen, known by the brand names Advil and Aleve. In any
case, people can safely stop taking the drug now -- without having
to taper off -- and talk to their doctor about alternative
options, says Mark Fendrick, professor of medicine at the
University of Michigan, Ann Arbor.
To
be sure, a Vioxx patient's absolute risk of a heart attack is
small. The trial prompting Merck to pull the drug involved 2,600
patients, half of whom took 25 milligrams of the drug a day, and
half of whom took a placebo. Among patients taking Vioxx for more
than 18 months, there were 15 heart attacks or strokes for every
1,000 patients compared with 7.5 per thousand who were on placebo.
For patients who took the drug 18 months or less, there wasn't any
increased cardiovascular risk, according to Merck.
The
doubling of risk and the availability of other treatments were
among the factors that prompted the decision to withdraw the
medicine.
Given
the unanswered questions about the whole class of drugs, some
doctors say people at risk of heart disease shouldn't take the
COX-2 drugs at all. But for some, the pain is so great they are
willing to bear the increased risk of heart problems. George Roddy,
a 58-year-old appliance salesman from Bowling Green, Ky., took
Vioxx for five years until his health insurer pushed him to switch
to Celebrex. But although he is at risk of heart disease and
sometimes has chest pains, he plans to stay on the Pfizer drug.
Over-the-counter medicines don't help him. "If I don't take
it, the pain in my knee is excruciating," he says of Celebrex.
"It would be hard for me to work."
Celebrex
isn't the only option for people with stomach problems. Dr.
Fendrick of the University of Michigan points out that an older
pain drug can be combined with drugs called proton-pump inhibitors
that treat ulcers and gastro-reflux disease. For example, a
patient could take Advil and Pepcid in combination.
But
Advil, Motrin and Aleve -- known as nonsteroidal anti-inflammatory
drugs -- must be taken more than once a day (unlike Vioxx and
Celebrex), and some patients like Mr. Roddy don't get relief from
them. "For reasons we don't understand there's a lot of
patient variability. It's not unusual for patients to try several
options before finding one that works," says rheumatologist
John H. Klippel, president of the nonprofit patient-advocacy
group, the Arthritis Foundation.
Brigham
and Women's Dr. Solomon believes that the COX-2 class has been
overused and that the withdrawal of Vioxx will give doctors and
their patients a chance to reconsider exactly who needs them.
"They are expensive and only should be used in patients at
high risk for gastrointestinal bleeding," he says. "This
is an example of how patients and doctors think that newer drugs
are better than older less expensive drugs." Dr. Klippel is
another who argues against a knee-jerk switch to another COX-2.
Along with over-the-counter drugs, he advises people suffering
from arthritis pain to try dieting and exercising.
"Osteoarthritis is clearly associated with being overweight
and paying less attention to exercise," he says.
Doctors
say there aren't any tests available to indicate whether a person
has already suffered heart or blood vessel damage that increases
their risk of disease. Vioxx and other COX-2 medicines inhibit a
protein that promotes the health of blood vessels and thus can
provoke the formation of clots.
While
research is limited, many doctors feel that once a person stops
taking the drug, any risk of clot formation likely diminishes or
goes away. "Generally the risk of association with a medicine
goes away when you stop taking it," Antonio Gotto, a
cardiologist who is dean of Weill Medical College of Cornell
University in New York City. "But since we don't know what
caused the problems with Vioxx, I'm unsure how long the risk is
increased," he says. Merck has said that it would follow
people from the halted Vioxx trial for a year to see how they
fare.
If
patients covered by most major managed-care companies switch from
Vioxx to another COX-2 drug, their insurance coverage isn't likely
to change. Many companies already relegated Vioxx, Celebrex and
Bextra to their third, or most expensive tier of coverage, meaning
patients pay more out of pocket if they take them.
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That
is the case with UnitedHealth Group, which was among many
plans that posted a notice of the Vioxx withdrawal on their
Web sites and to counsel patients with questions. Empire
Blue Cross Blue Shield, the largest health insurer in New
York, had placed Vioxx on its preferred brand, or second,
co-payment tier, while Bextra and Celebrex were on the
third, more expensive tier. After Merck's announcement,
Empire said it would now cover Celebrex and Bextra at the
same co-pay it had for Vioxx. |
--Vanessa
Fuhrmans contributed to this article
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