[READ NOW!]'Fast-Track' Drug to Treat Diabetes Tied to 33 Deaths
Sunday, December 6, 1998
LA Times
SUNDAY REPORT
Rezulin: The FDA dismissed warnings on the pill, but it was withdrawn in
Britain. Agency and Warner-Lambert say treatment is safe when prescribed
and used properly.
By DAVID WILLMAN, Times Staff Writer
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ASHINGTON--The Food and Drug
Administration dismissed explicit warnings
of danger as the agency raced to approve a new
diabetes drug that has been linked to at least 33
deaths due to liver injuries, records and interviews show.
Senior FDA officials reviewed the drug on a "fast track" while
downplaying harmful potential side effects. The drug, a pill called
Rezulin, has become a sales sensation since it was launched in
March of 1997 by the Warner-Lambert Co., a major U.S.
pharmaceutical manufacturer and maker of consumer products such
as Dentyne chewing gum.
The first reported deaths due to liver failure prompted the
withdrawal of Rezulin one year ago in Britain. The FDA and
Warner-Lambert have kept the drug on the U.S. market while
instructing doctors on three separate occasions to take additional
steps to protect patients with adult-onset diabetes.
But previously undisclosed cases acknowledged by FDA
officials Friday show that these precautions have not slowed the
pace of patient deaths. The new total of 33 deaths related to use of
Rezulin in the United States and Japan is up from the 21 fatalities
reported by the FDA as of June.
The FDA's handling of Rezulin is shaping up as a nightmare: One
medical officer who opposed the approval of Rezulin was removed
as the chief reviewer of the drug.
Two other FDA physicians who recommended approving the
drug conceded in interviews that the agency initially overlooked
compelling evidence of Rezulin's danger to the liver.
The FDA decision to approve Rezulin without
at least recommending that patients undergo
precautionary liver testing "was an enormous blunder," said Dr. Curt
D. Furberg, a drug testing specialist and head of public health
sciences at Wake Forest University.
"The agency failed," said Furberg, who is familiar with the FDA's
review and oversight of the drug. "It's amazing that Rezulin is still on
the market."
The FDA and Warner-Lambert say that Rezulin is safe for the 1
million or more reported users of the drug when prescribed and
used properly.
"We believe this drug brings a unique and significant benefit for
patients," said Dr. Randall W. Whitcomb, Warner-Lambert's vice
president for diabetes research. "And while it has a risk, [this] is
true of all medications."
Adult-onset diabetes affects 15 million Americans and is
characterized by high blood-sugar levels that can increase the risk
of heart disease and cause other complications. It is distinct from
juvenile-onset diabetes, whose victims would die without daily
injections of insulin.
The story of Rezulin is a window on the new era of accelerated
approval for newly proposed medications. This shift has come amid
complaints from pharmaceutical companies and patient activists that
the FDA had taken too long to approve medications that could save
lives.
The regulation of prescription drugs involves both science and
art--the weighing of risk versus benefit. Some patients with AIDS
or advanced cancer, for instance, are willing to accept extreme risk
for new, experimental treatments.
The story continues in some 20 more sections, starting with the following link:
latimes.com
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