Kaiser Permanente, one of the largest managed care
organizations, has ordered its pharmacies to stop dispensing
Bextra, an arthritis and pain drug made by Pfizer that
some tests have indicated may increase the risk of heart
attacks and strokes.
Bextra is in the same class of drugs as another Pfizer
painkiller, Celebrex, which has also been found to pose
cardiac risks at high doses, and as Vioxx, the drug
that Merck pulled from the market last fall after its
own tests disclosed cardiac risks.
Merck announced yesterday that the Securities and
Exchange Commission had opened a formal investigation
of Merck's handling of issues related to Vioxx.
The suspension of Bextra is the first case of Kaiser's
doctors deciding to ban use of a drug that has been
approved by the Food and Drug Administration, said Dr.
Sharon Levine, associate executive director of the company's
Northern California unit.
Dr. Levine said the decision was unlikely to affect
many of Kaiser's nine million patients around the country,
since Kaiser physicians had already avoided using the
drug. But "for safety and quality reasons, we don't
want to be involved in dispensing this drug," she said.
A ban by Kaiser, whose practices are in many ways a
model for other health care providers, could further
damp sales of Bextra, which had sales last year of $1.29
billion. Those sales have already slumped since Pfizer
acknowledged last fall that studies had shown that the
drug increased the risks of heart attack and stroke
among patients who have had coronary artery bypass surgery.
Many experts have speculated that its risks could be
as high as Vioxx's.
Kaiser doctors will continue prescribing Celebrex,
Dr. David Campen, Kaiser's medical director of pharmacy
services, said yesterday. At low doses, Celebrex does
not appear to have the same risks as Bextra or Vioxx,
Dr. Campen said.
"But clearly at the higher dose levels, there does
seem to be a problem" with Celebrex, he said.
A Pfizer spokeswoman said the Bextra tests in question
had involved patients after heart surgery, who were
not the target population for the drug, which was federally
approved to treat arthritis inflammation and pain. "All
the available data suggests there is no increased risk
of heart attacks among arthritis patients who take Bextra,"
she said.
Kaiser said that its Bextra ban would take effect on
Feb. 1 for new prescriptions and March 1 for refill
prescriptions. The lag is intended to give the group
enough time to inform the doctors and dentists who see
Kaiser patients, Dr. Levine said.
Dr. Levine said that Kaiser took its action against
Bextra because the drug had no unique benefits but plenty
of possible risks. Clinical trials have found that Bextra
cures pain no better than older medicines like ibuprofen
and diclofenac. And while Bextra is theoretically supposed
to be safer on the stomach than older medicines, this
benefit has never been proved in a clinical trial.
Bextra, in rare instances, can also cause a fatal skin
rash. Both Bextra and Celebrex should be avoided by
people with allergies to sulfa drugs, according to label
warnings mandated by the F.D.A.
The F.D.A. has counseled physicians to limit prescriptions
of Bextra and Celebrex in the aftermath of studies that
found an increased the risk of heart attacks and stroke.
The agency has scheduled a three-day hearing of independent
experts next month to discuss Vioxx, Bextra and Celebrex.
That panel is expected to recommend how the medicines
should be regulated.
Merck withdrew Vioxx in September after a study showed
that it doubled the risk of heart attacks and stroke.
An F.D.A. drug-safety reviewer estimated that as many
as 55,000 deaths might have resulted from taking Vioxx,
and Merck is facing numerous lawsuits from former Vioxx
users or their families.
Beyond disclosing the S.E.C. investigation yesterday,
Merck declined to comment beyond a written statement,
saying "This action was not unexpected and the company
will continue to cooperate with the S.E.C." The S.E.C.
also declined to comment.
Analysts say that the inquiry may focus on whether
Merck misled its shareholders about the safety of Vioxx.
Some internal company documents that have come to light
during Vioxx litigation suggest that executives may
have known about Vioxx's safety problems several years
ago but covered them up.
A Merck spokesman yesterday said that the company "acted
responsibly every step of the way, from researching
the drug prior to approval to monitoring the drug while
it was on the market to voluntarily withdrawing the
drug when it did."
The company previously announced that the Justice Department
was also investigating the Vioxx case "under criminal
statutes."