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Re: Merck Withdraws Arthritis Drug Vioxx
Re: Merck Withdraws Arthritis Drug Vioxx -- Posted by Steve on 10-04-04 10:54
(Scott Gottlieb, MD, Forbes Magazine)---Vioxx was long maligned by
critics who charged it was no better than ordinary painkillers such as
Motrin or Advil, nor better than its close competitors such as
Celebrex. These critics derided the existence of what they call "me
too" drugs, similar medicines that are in the same class because they
are chemically similar and designed to treat the same conditions.
Drugs like Vioxx are called Cox 2 inhibitors because they selectively
inhibit pathways that cause pain but, unlike other similar
painkillers, they do not block pathways in the body that also produce
chemicals that protect the stomach's lining.
That an ordinary painkiller such as Johnson & Johnson's Motrin caused
serious upset stomach is a fact given short shrift by critics of the
Cox 2s, who see only their higher price tag. These benefits, including
reduced discomfort from stomach upset or the lower risk of dangerous
ulcers, are worth every penny for the patients who need them.
More importantly, the Cox 2 drugs are also proving themselves to be
potent anticancer agents. One Cox 2 drug has already earned the right
to promote itself as a preventative treatment for colon cancer. In
this case, the treatment is indicated only for patients with a rare
genetic disorder that leaves them at an unusually high risk of the
disease. But Merck was doing a study examining whether Vioxx would be
a more potent anticancer drug for a much broader spectrum of patients
when it unearthed the side effect that forced its withdrawal.
This is how medical progress is made. Few new drugs reveal all of
their benefits when they are first approved. It is only through a
painstaking process by which drugs are prescribed for patients that
new uses are teased out, new side effects discovered and the full
potential of a drug is finally realized. This has more to do with the
serendipity of the human body and its response to medicines that any
shortcomings of our scientific process.
Critics of the current drug approval process and of the high cost of
new medicines, have taken to arguing that new drugs should be approved
only after they have demonstrated that they are better than the next
best thing. In other words, the FDA should require drugs to be tested
in head-to-head studies where they are compared to alternative
treatments rather than a sugar pill, and they should have to beat
their competitor to win approval.
But many medicines are not initially approved for the conditions where
they ultimately provide the most benefit. When many drugs are first
launched, few people envision the full range of potential conditions
where they may one day be useful. Sometimes a drug's true benefits are
discovered by deliberate studies, called follow-on trials that examine
new uses for a medicine. Other times it is stumbled upon - a patient
being treated for one disease also suffers from another condition that
seems to clear up once the drug is given.
Few would have thought when the ACE inhibitors were first launched for
high blood pressure that this class of drugs would also treat the
damage left by heart attacks. Few envisioned that Taxotere, originally
approved for breast cancer, would ultimately work in prostate cancer.
Now the popular anti-impotence drug Viagra is being tested in some
promising trials for treatment of high blood pressure in the lungs of
newborns.
The withdrawal of Vioxx is not going to leave a gaping hole in the
therapeutic armamentarium of most doctors, since there are similar
drugs already on the market and a few more to soon follow.
But for those tempted to see its withdrawal as a triumph of older
drugs over small advances, Vioxx was different from its competitors,
even its "me too" cousins, in ways that made it an important choice
for certain patients. And the competition between drugs like Vioxx and
Celebrex advanced our scientific knowledge about their benefits and
their risks. On Thursday, this competition revealed some new problems,
prompting Merck to pull its drug off the market, advancing medical
practice and giving doctors important new ideas.
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