Washington Post article:
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FDA Panel Backs First of 'Super Aspirins'
for Arthritis Inflammation
By Justin Gillis
Washington Post Staff Writer
Wednesday, December 2, 1998; Page A06
An expert panel recommended yesterday that the Food and Drug
administration approve a new drug for people suffering from arthritis, the
first of a long-awaited class of "super aspirins" that may be useful for many
kinds of pain and inflammation.
By unanimous vote, the committee of doctors and other experts
recommended that the FDA approve the drug, called celecoxib, for sale
by prescription for the treatment of osteoarthritis and rheumatoid arthritis,
diseases that afflict millions of Americans.
But the committee tempered its recommendation by urging that the drug
carry some of the same warnings about potential side effects as older
inflammatory drugs, including the possibility of damage to the lining of the
stomach and small intestine. And the panel declined to endorse use of the
drug for acute pain of the sort that follows having a tooth pulled. Several
panel members said more studies were needed on the drug's effectiveness
for that purpose.
The FDA is not required to follow the recommendations of its advisory
panels, but usually does and is expected to do so in this case, approving
the drug initially for arthritis.
The drug would be sold under the brand name Celebrex, according to
officials at G.D. Searle & Co., a Monsanto Co. subsidiary that developed
the drug.
Similar compounds are under development at drug companies around the
world.
Celebrex targets an enzyme called cyclooxygenase, or COX, which is
present in many types of inflammations. So do older drugs like aspirin,
Advil and various prescription products.
However, in recent years scientists have realized that COX is found in the
body in two slightly different forms, dubbed COX-1 and COX-2. Their
precise roles are still being studied, but the evidence suggests that COX-1
is more involved in the body's "housekeeping" functions, such as protecting
the lining of the digestive tract, while COX-2 is more involved in the pain
and inflammation associated with ailments such as arthritis.
Older anti-inflammatory drugs work by reducing both forms of COX.
Companies are rushing to bring to market highly selective "COX-2
inhibitors" like Celebrex, on the theory that they will be safer. About
100,000 Americans are hospitalized every year for bleeding ulcers and
other digestive complications caused by anti-inflammatory medicines. From
10,000 to 20,000 people die each year from taking these drugs.
Searle presented studies yesterday showing that the drug was clearly
effective at reducing arthritis symptoms such as chronic pain. And
Celebrex appeared to have a lower incidence of damage to the digestive
tract caused by many common medicines used for pain and arthritis.
Searle argued that serious intestinal complications with its drug were close
to the "background rate" for people not taking any anti-inflammatory drug.
This position has been reflected in many popular accounts of the "super
aspirins," which have been portrayed as having no side effects. "It certainly
is the impression many people hold," said Robert H. Palmer, group
director for rheumatology at SmithKline Beecham, a Searle competitor.
But the claim of no side effects was disputed yesterday, with Palmer and
other critics arguing that it remains to be seen exactly how serious stomach
and intestinal problems will be for those on Celebrex.
The FDA panel adopted a middle ground, urging the agency to warn
doctors about the potential for serious side effects while alerting them to
the Searle studies suggesting the drug is relatively safe. Eventually, panel
members said, wide use of the drug should clarify the safety issue.
Studies have also shown that Celebrex can cause many of the same rare
side effects, such as kidney problems, as other anti-inflammatory drugs.
Research is underway to clarify whether and how to use the drug in other
conditions. Preliminary evidence is that COX-2 inhibitors may, for
instance, be useful in slowing or preventing the onset of Alzheimer's disease
and colon cancer.
The fate of Celebrex has been closely watched on Wall Street, as millions
of people may eventually take COX-2 inhibitors. Shares of Monsanto
closed at $43.50, down $1.8125.
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