Drug to Relieve Pain and Inflammation Is Winner
LA Times
Saturday, June 26, 1999
Pharmaceuticals: Six million prescriptions for Celebrex make it most
successful new product launch in the business.
From the Washington Post
A drug designed to relieve pain and inflammation has become
the most successful new-product launch in the history of the
pharmaceutical business, eclipsing the anti-impotence drug Viagra.
About 6 million prescriptions for the drug Celebrex have been filled
in less than six months.
Celebrex, developed by the G.D. Searle unit of Monsanto Co.,
is the first of a new class of anti-inflammatory drugs designed to be
particularly useful in chronic ailments like arthritis. The second drug
in the class, developed by Merck & Co. and known as Vioxx, was
approved last month, and about 126,000 prescriptions were written
for it in its first 30 days on pharmacy shelves.
A slew of similar compounds are under development at other
companies. The new drugs have been widely referred to as the
"super aspirins," a somewhat misleading moniker since it implies that
they offer dramatic pain relief. They offer about the same degree of
pain relief as older medicines like aspirin, Advil and Aleve, but they
appear to be much safer when taken over long periods at high
doses.
Many people, particularly those with arthritis who feared taking
strong painkillers because they can cause ulcers, digestive bleeding
and other serious problems, are finding welcome relief with the new
treatments.
"It was like Midas had touched me and I was a pot of gold,"
said Margaret Burton of Olney, Md., who started taking Celebrex
for her arthritis earlier this year. "I just felt like a different woman.
It's like the fountain of youth, to put it mildly."
The drugs, though expensive and not without risks of their own,
offer a new option to satisfy one of mankind's oldest needs.
Modern pharmacology began in 1893, when a German chemist
for Bayer AG, worried about his father's arthritis, tweaked a
substance from the bark of the willow tree to produce acetylsalicylic
acid, better known as aspirin. The drug suppressed an enzyme
known as cyclo-oxygenase, or COX, which plays an important role
in pain and inflammation. Many of the painkillers developed in
succeeding decades worked the same way.
But in recent years scientists discovered that COX comes in two
forms, dubbed COX-1 and COX-2. COX-1 seemed to play an
important role in protecting the lining of the stomach and intestines,
while COX-2 seemed more directly involved in the pain and
inflammation of diseases like arthritis. Older drugs inhibit both
enzymes, which partially explains their ability to harm the stomach.
Frenzied work began to develop potent, highly specific inhibitors of
the COX-2 enzyme, and it is these drugs that are now coming to
market.
"This is an advance in our basic understanding of molecular
chemistry that has made it from the laboratory to the bedside," said
Herbert S.B. Baraf, a Washington-area rheumatologist who helped
research the new drugs. "It should make a tremendous difference. I
really believe that these drugs will become the standard of care" for
arthritis.
In large-scale human tests, they have indeed proved safer than
older drugs, though the full story won't be known until the drugs
have been on the market for years and have been taken by tens of
millions of people. So far, there seems to be no unexpected
elevation in the rate of deaths among people taking Celebrex, the
most widely used COX-2 inhibitor. By contrast, aspirin and similar
drugs are believed to cause 5,000 to 10,000 deaths a year in the
United States, primarily by damaging the intestinal tract.
Many of the 22 million Americans with arthritis already swear by
the new treatments. Some of them couldn't take older drugs
because they had suffered stomach damage or were at high risk,
and they were consigned to weak arthritis treatment or none at all.
One drawback to the new drugs is cost: $2.50 to $3 a day for
treating arthritis, three times the cost of treatment with older
painkillers. Moreover, while the risk of stomach damage appears
lower than with older drugs, there is believed to be some risk, and
the new drugs, like older painkillers, can cause serious kidney
problems in a few people.
Finally, the new drugs don't seem to work for everyone. As with
older treatments, genetic variations seem to play a role in how
people respond.
Still, experts are generally convinced the drugs are safer than the
ones they are meant to replace. Particularly in arthritis patients who
have had stomach problems taking existing drugs, doctors are
racing to write new prescriptions.
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