Drugmaker to defend death-linked diabetes pill
Wednesday, March 24, 1999
By HARLAN SPECTOR
PLAIN DEALER REPORTER
Two years ago, diabetics were offered a promising new drug
that would lower blood sugar and could make treatment as
simple as a pill a day.
Rezulin caught on quickly with those afflicted with adult-onset
"Type 2" diabetes, and the drug now has about 1 million
users.
"Everybody wants to be saved from taking shots - not hard to
understand, is it?" said Dr. Peter O. Schumacher, a University
Hospitals endocrinologist.
But on Friday, drugmaker Warner Lambert will defend Rezulin
before a federal panel reviewing dozens of reported deaths
from liver failure linked to the drug.
Rep. Sherrod Brown, Democrat of Lorain, is among those
awaiting the results of the review by an advisory panel of the
Food and Drug Administration.
"The burden of proof is on Warner Lambert to show this drug is
not nearly as dangerous as it appears," said Brown.
The congressman, the ranking member on the Subcommittee
on Health and Environment, was co-author in December of a
letter to FDA Commissioner Jane Henney questioning the
safety of Rezulin. The congressman, citing investigations of
the drug by the Los Angeles Times and the consumer group
Public Citizen, also questioned the agency's accelerated
approval of the drug, despite warnings of its dangers. The FDA
responded in February that there have been 33 deaths from
liver failure "associated with the use of Rezulin," including
eight in Japan. It said another five people needed liver
transplants.
Warner Lambert puts the number of Rezulin-related deaths at
28, and the Los Angeles Times published its own research
showing that 91 Rezulin patients who have died showed signs
of liver damage.
Updated numbers are expected to come out Friday. But
experts agree the documented cases of death and liver
damage are understated, as the reporting system is voluntary.
"It is likely there are hundreds of deaths right now," said Dr.
Sidney Wolfe of Public Citizen, which petitioned the FDA in
July to ban Rezulin. Wolfe, an adjunct professor at the Case
Western Reserve University School of Medicine, says labeling
changes that enhanced warnings and recommendations for
Rezulin use have been ineffective for preventing liver failure.
"No one in their right mind would prescribe this drug," he said.
But plenty of physicians do, and they strongly disagree with
Wolfe. They say that with proper liver function monitoring,
Rezulin is a good and relatively safe drug.
Unlike most diabetes drugs, which stimulate the pancreas to
produce more insulin, Rezulin breaks down resistance to the
body's own insulin, making it more efficient.
"That's why everybody loves it, because it's the only pill that
works on the real problem. Others just cover it up," said Dr.
Robert Brenner of the Diabetes and Endocrine Center of
Cleveland.
Rezulin only works for adult-onset, or Type 2, diabetes, in
which the body produces insulin but not enough to keep high
levels of blood sugar from building up in the bloodstream.
Milder cases can be controlled with diet and exercise, while
others require oral medication or insulin shots.
Type 2 is far more prevalent than juvenile-onset diabetes - 5
percent of adults have it - and it represents a considerable
market for drug companies. Warner Lambert said it had $748
million in Rezulin sales last year.
"I would hate to see a blanket statement - one should never
use this medication," said Dr. Sethu Reddy, program director
in the Department of Endocrinology at the Cleveland Clinic.
Reddy and other physicians say the benefits of the drug
outweigh the risks, provided liver toxicity is monitored. He
believes the evidence isn't there to show Rezulin is dangerous.
Doctors who prescribe it argue that statistically, you are far
more likely to die from penicillin than Rezulin.
"If I tell you that 400 people died this quarter in car accidents,
does that mean you should stop driving a car?" Reddy said.
Endocrinologist Dr. Adrian Schnall of University Suburban
Health Center says risks of dramatic drops in blood sugar from
the most common diabetes drugs are far greater than the risk
of Rezulin.
"Life-threatening low blood sugar is far more common than liver
failure due to Rezulin," he said. Schnall also said there was
evidence that Rezulin reduces risk of heart attack and stroke.
Since Rezulin was approved in 1997 with no liver testing
recommendation, the FDA has changed its labeling three
times - recommending additional liver testing in each instance.
One recommendation for stepped-up testing came in
December 1997 after Britain withdrew Rezulin from the market,
citing safety concerns. The FDA now advises liver monitoring
11 times in the first year a patient uses the drug.
Whether that has cut the rate of deaths and liver damage will
be a key point for the FDA panel to determine.
Many endocrinologists say that with such vigilance, the risk of
liver damage is low - certainly a fair tradeoff with potential
complications from insulin injections and other drugs.
Paul Metrovich, 59, is a satisfied Rezulin user because it is
the first diabetes drug he has taken that has kept his blood
sugar in check.
"I'm concerned about it, but not overly concerned," said
Metrovich, of East Liverpool, who has liver tests every two
months. "The risks of elevated blood sugar for a long time are
greater than the risks of Rezulin."
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