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WASHINGTON (Reuters) Nov 18 - The U.S. Food and Drug Administration
failed the public in its oversight of Merck & Co Inc.'s painkiller
Vioxx, which has been withdrawn, and is "incapable of protecting
America" from another dangerous drug, an agency researcher
told Congress on Thursday.
David Graham, an FDA reviewer who had warned about the heart risks
of Vioxx, called the FDA's actions "a profound regulatory failure."
Concerns about a possible link between Vioxx and serious heart
problems were building during the drug's more than four years on
the market. The FDA required a warning about the heart risk but
felt the drug's benefits made it worth keeping on the market.
Merck withdrew Vioxx on Sept. 30 after a study showed the drug
doubled heart attack and stroke risk.
"I would argue the FDA as currently configured is incapable
of protecting America against another Vioxx. We are virtually defenseless,"
Graham told the Senate Finance Committee.
Committee Chairman Charles Grassley, an Iowa Republican, said he
was concerned the FDA had a "far too cozy" relationship
with drug companies and suggested an independent office of drug
safety might be needed.
Sandra Kweder, deputy director of the FDA's Office of New Drugs,
said the agency "worked actively and vigorously with Merck
to inform public health professionals of what was known regarding
(cardiovascular risk) with Vioxx and to pursue further definitive
investigations."
Graham told the committee he felt pressured by supervisors to water
down his findings from a study of patient insurance records that
Vioxx users had a 50 percent greater chance of heart attacks and
sudden cardiac deaths than people who took Pfizer Inc.'s rival medicine
Celebrex.
In a statement Wednesday, Acting FDA Commissioner Lester Crawford
said Graham had violated long-standing procedures for publishing
scientific findings when he submitted his research to a medical
journal without FDA clearance.
Grassley said Crawford's statement appeared intended to intimidate
a witness on the eve of a hearing.
Utah Republican Sen. Orrin Hatch cautioned fellow senators to keep
an open mind, saying: "Today some are trying to punish one
drug company for acting appropriately within the framework of our
regulatory system."
But Grassley said Vioxx was the second example this year of the
FDA not having proper respect for it own scientists. Another FDA
reviewer, Dr. Andrew Mosholder, had warned antidepressants were
linked to suicidal behavior in pediatric patients, but supervisors
initially kept him from making those views public.
"Now we have scientists in this particular (Vioxx) case who
are being harassed within the agency because of sticking to their
own science," Grassley said.
Grassley also faulted Merck for aggressively marketing Vioxx for
nearly two years between submitting results of a trial to the FDA
in June of 2000 showing a higher incidence of cardiac problems with
Vioxx and the FDA approving a new label detailing those risks in
April 2002.
"A blockbuster drug became a blockbuster disaster," Grassley
said.
Merck Chief Executive Raymond Gilmartin, in written comments, said
the company followed "a rigorous scientific process at every
step of the way with Vioxx."
"Over the past six years, we have promptly disclosed results
of numerous Merck-sponsored studies to the FDA, physicians, the
scientific community and the media," Gilmartin said. (Additional
reporting by Susan Heavey and Tim Dobbyn)
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