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TRICARE FINDS NO EVIDENCE THAT THEIR PATIENTS
GIVEN
AVANDIA HAVE MORE HEART ATTACKS -- Statement
comes as
diabetes drug stays on market but with more
warnings.
Story here...
http://www.nytimes.com/
2007/07/31/health/31drug.html?_r=1&
hp=&adxnnl=1&oref=slogin&adxnnlx=
1185887768-TBv8phuHpX5xq1WFO4Cwcg
Story below:
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Diabetes Drug Backed, but With Warnings
By GARDINER HARRIS
GAITHERSBURG, Md., — A federal drug advisory committee voted
overwhelmingly on Monday to recommend that the diabetes drug Avandia
remain on the market, even after finding that it raised the risks of
heart attacks.
Panel members said that studies concerning Avandia were too murky to
merit drastic regulatory action and that other diabetes medicines might
have similar risks.
The votes — 20 to 3 on the heart attack risk and 22 to 1 on the
marketing — were cast after an extraordinary meeting in which officials
from the Food and Drug Administration, which brought the committee
together, openly disagreed with one another on the course to take.
Dr. David Graham, a drug safety officer at the federal agency, called
for withdrawing the drug and estimated that its toxic effects on the
heart had caused up to 205,000 heart attacks and strokes, some fatal,
from 1999 to 2006. For every month that Avandia is sold, Dr. Graham
said, 1,600 to 2,200 patients will suffer more of those problems.
Dr. Robert Meyer, director of the F.D.A. office that approved the
initial Avandia application, immediately disagreed.
“I think it’s important that the committee understand there’s a
fundamental disagreement” within the agency, Dr. Meyer said.
Other diabetes drugs also have risks, he added, and doctors and patients
need a variety of options.
After the votes, Rebecca Killion of Bowie, Md., a patient representative
on the advisory panel, said, “My feeling here is that we’re being asked
to take a very draconian action based on studies that are very
inadequate for us to make that kind of decision.”
The panel did say the agency should require strict warnings on Avandia
labels.
“When this particular drug is used,” said Dr. Gerald Van Belle, a
committee member from the University of Washington, “there must be some
care taken in who gets it.”
The division in the agency reflects a fierce debate among diabetes
experts since The New England Journal of Medicine published a study in
May suggesting that Avandia, made by GlaxoSmithKline, increased the
risks of heart attacks.
In a cascade of reports since then, agency officials have said that
GlaxoSmithKline told the agency about this risk nearly two years ago but
that because of internal disagreements, it never warned patients.
In Europe, regulators required that the drug label reflect some concerns
about the risks.
The lack of action here helped persuade some lawmakers to support a
measure giving the agency more money and power to police drug safety.
That bill has passed both houses of Congress and is expected to go to
President Bush in days.
About a million patients in the United States took Avandia last year. A
nearly identical number took Actos, a similar pill made by Takeda, which
some studies suggest may be safer. Avandia global sales last year were
$3.4 billion, but they have plunged since May.
The controversy largely revolves around highly complex statistical
analyses of dozens of studies on Avandia and the heart attack risks.
Separate from this argument, the evidence is overwhelming that Avandia
and Actos worsen heart failure, a chronic condition in which the heart
can no longer pump enough blood through the body.
GlaxoSmithKline argued strongly to the panel that its drug was safe. A
vice president, Dr. Murray Stewart, said the company had in recent
months examined data on 1.35 million diabetes patients from large
managed care companies. The analyses, Dr. Stewart said, showed that
patients on Avandia suffered no greater risk of heart problems than
patients on other drugs.
The committee disagreed, with most members calling for strict warning
labels.
“I also think there needs to be a stiffening of the warnings,” said Dr.
Peter J. Savage, a panel member from the National Institutes of Health,
echoing others’ comments.
Dr. Steven Nissen, a Cleveland Clinic cardiologist who wrote the May
study, said in an interview after the hearing that he would have voted
to remove Avandia from the market. But Dr. Nissen said he was cheered
that the panel had “affirmed the finding that there was an increased
cardiovascular risk from the drug.”
The disagreements within the agency affected almost every aspect of the
hearing. In their presentations, Dr. Graham and his boss, Dr. Gerald Dal
Pan, referred to studies suggesting that Actos had fewer heart risks
than Avandia. The agency has not thoroughly reviewed the Actos studies,
and the underlying data were not given to panel members.
Dr. Graham said, “We were promised that that would be done for this
meeting,” but added that officials said the agency did not have enough
resources to finish the analysis done for the meeting.
“So then I’m faced with a dilemma,” he said. “Do I keep silent about
that and not breathe a word of it or do I present it?”
The debate on Avandia has led to a remarkable number of independent
examinations of its safety, and researchers shared their findings with
the committee.
Executives of Tricare, a managed care company that serves active and
retired military personnel, and WellPoint, a huge health insurer, said
they had found no evidence in their records that patients given Avandia
had suffered more heart attacks.
Dr. Sidney Wolfe of Public Citizen, the drug safety advocate, said
agency records showed Avandia had many more associated problems than
just heart risks, including increased risks of fractures and liver
failure.
“If Avandia were up for approval today,” Dr. Wolfe said, “based on what
we know now, it would be rejected.”
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Larry Scott --
