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| September 18, 2004
OP-ED CONTRIBUTOR
Information Is the Best Medicine
By JOHN ABRAMSON
http://www.nytimes.com/2004/09/18/o...print&position=
Measures to make the results of drug trials more accessible to
doctors and the public, as well as the federal government's probable
stiffer warnings on the use of antidepressants for children, are
definitely
steps in the right direction. But my experience as a family doctor on
the front
lines of medicine leads me to believe that these moves won't be enough
to
curb the influence of the drug companies on our health care.
The impetus for these changes comes largely from revelations in
the Food and Drug Administration's review of the new class of
antidepressants, known as selective serotonin reuptake inhibitors, in
the treatment of depression in children and adolescents. Many studies,
the review found, show that the drugs are no more effective than
placebos, but significantly increase the risk of suicidal tendencies.
So why are doctors writing millions of prescriptions each year to
treat depressed children with
these drugs?
Much of the problem stems from drug companies' unequal
treatment
of the clinical trials they sponsor. Findings that support drug sales
tend
to get published in medical journals, and become accepted as fact.
Unfavorable findings often don't see the light of day. This leaves
even the most dedicated doctors and best informed patients (and
parents) unaware of
important evidence about the drugs they're prescribing and using.
In response, the editors of 11 of the world's leading medical
journals have agreed to publish only studies that are registered at
the
outset. Registration creates a trail, making it more difficult to
suppress unfavorable results. Legislative efforts are also under way
to make
completed studies available to the public.
There are many examples, however, of drug sales skyrocketing
despite the availability of research showing negative results or
serious side
effects. An article published in the Archives of General Psychiatry in
April 2000 provides a preview of the limited effect that we can expect
from
registering and posting results of all studies. In this case,
researchers obtained the results of all clinical trials of new
antidepressants like Prozac, Paxil and Zoloft done from 1987 to 1997,
published and
unpublished, from the F.D.A. under the federal Freedom of Information
Act.
The pooled results showed that an older class of
antidepressants, known as tricyclics, was actually more effective,
belying all the hype about the "revolutionary'' new antidepressants.
The researchers reported that among the longer-term studies (which
better reflect actual use), the new antidepressants were 8 percent
more effective than placebos, while
tricyclics like Elavil were 12 percent more effective.
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The most
disturbing finding was that more than twice as many depressed adults
on new
antidepressants kill themselves than those taking placeboes. The
difference was 8.4 versus 3.6 suicides per 1,000 patients a year,
respectively.
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How much impact did the availability of these results have on
doctors' prescribing patterns? Evidently not much: the new
antidepressants remained the best-selling class of drugs in the United
States in 2000
and 2001.
The medical journal editors understand that just registering
studies isn't enough. Their real goal is full transparency in clinical
trials,
meaning that research plans and complete data from studies should be
available for independent review. But even this is not sufficient to
counteract commercial influence, as the cases of the blockbuster drugs
Celebrex and Vioxx demonstrate.
The results of large manufacturer-sponsored studies of these
two
arthritis drugs were published in The Journal of the American Medical
Association and The New England Journal of Medicine, respectively, in
2000. The original data upon which both articles are based have been
posted
on the F.D.A. Web site since February 2001.
Both drug-company sponsored articles led doctors to believe
that
their patients would be better served by prescribing the new drugs.
But
the data posted on the F.D.A. Web site tell a very different story.
Patients on Celebrex did not have significantly fewer serious
gastrointestinal
problems than those who took the older types of arthritis medicine.
In fact, during the second six months of treatment (data not
even mentioned in the article), users of Celebrex developed serious
gastrointestinal problems more often than users of the older drugs.
The
bottom line is that Celebrex is much more expensive, provides no
better
relief of arthritis symptoms, and overall causes 11 percent more
serious complications than the other drugs.
The data about Vioxx offer an answer to the supposedly
unresolved question - whether it increases the risk of heart attacks,
strokes and blood clots. Even among people without elevated risk,
those taking Vioxx
suffered twice as many serious cardiovascular complications as those
who took
naproxen (sold as Naprosyn or Aleve). Most important, the data on the
F.D.A. Web site show that patients taking Vioxx developed 21 percent
more
serious complications than those who took naproxen.
Since that data was posted more than three years ago, American
doctors have prescribed more than $15 billion worth of Celebrex and
Vioxx. Full transparency, it appears, doesn't solve the problem of
commercial
influence either.
Given the drug industry's domination of our medical knowledge,
nothing short of an oversight board - modeled after the Federal
Reserve
Board, will make a real difference. The board's members must serve
lengthy terms to avoid political influence and have no commercial
ties. This
body would make use of the excellent work already being done by the
reviewers within the F.D.A. (though too often their analyses remain
invisible to the public) as well as the commercial, nonprofit, and
government-sponsored
research that is already being done.
Like the National Institute of Clinical Excellence in Britain
(which has a budget of less than $30 million a year), this board would
independently evaluate scientific evidence relevant to selected
diseases and treatments to determine optimal medical care including
lifestyle
changes. The board's recommendations would define the standards of
medical care
based on what is best for Americans' health, not what will generate
the most
profit.
If the latest round of reforms relating to drug research stops
with registering and posting the results of clinical studies, it will
stand
only as window-dressing on a method of producing and disseminating
medical
knowledge that is better designed to serve drug makers' interests than
to improve Americans' health.
John Abramson,a clinical instructor at Harvard Medical School,
is the
author of the forthcoming"Overdosed America: The Broken Promise of
American Medicine.''
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