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Article Last
Updated: Sunday, June 20, 2004 - 3:40:23 AM PST

OTHER ARTICLES IN THIS
SECTION

6/21/2004

- Max
BOOT

- David
BROOKS

- H.D.S.
GREENWAY

- David
GRIMES

- Nicholas
VON HOFFMAN

- Michael
MANDELBAUM

- Patt
MORRISON

It's time to focus on information bias about
drugs

HEARING about an exciting new drug study
can make a pill sound so fantastic that we can hardly wait to take
it. We rush to our doctor's office to show her the newspaper
clippings, and for extra measure we bring along a few supporting
documents that we have downloaded from the Internet.

But suppose that one glorious study we heard about was just that
-- the one glorious study about that drug. Suppose that there
existed three or four additional studies that made that drug seem
undesirable or, at least, inglorious, and we had no way of knowing
about them. Suppose those hidden studies contained information about
side effects or contradictory data that suggested the drug really
didn't work.

It's unsettling to consider these possibilities, but it's
important to remain vigilant about them. Clinically important -- and
generally unfavorable -- information about drugs is often buried in
publicly inaccessible archives. Our medical journals tend not to
publish studies about drugs that were found to be duds in clinical
trials.

Hidden drug data poses a serious and pervasive problem. For
example, a recent study in the Journal of the American Medical
Association analyzed 102 drug trials and found that 50 percent of
efficacy data and 65 percent of harm outcomes were only partially
reported.

In certain circumstances, the suppression of drug information can
be heavy-handed. Researchers conducting trials funded by drug
companies have been required to sign contracts that grant the
companies the right to control which results get submitted for
publication. A few years ago, a vaccine manufacturer even filed a
multimillion-dollar lawsuit against a team of AIDS researchers who
insisted on publishing results from a clinical trial that found the
company's HIV vaccine to be worthless.

Furthermore, because there is no one place where all data about
drug trials and their results are stored, it becomes a bit of a
scavenger hunt to find all knowable information about a drug that
might interest you.

This is not a healthy system when you don't know where to look
for drug information, and you can't telepathically access what's
been kept out of publication.

A lawsuit filed this month in New York promises to challenge the
formidable power of the pharmaceutical companies to pick and choose
the information that gets disseminated and promoted in the public
domain. New York Attorney General Eliot Spitzer has decided to sue
drug manufacturer GlaxoSmith-

Kline PLC, claiming that it committed consumer fraud by
misrepresenting and withholding data about the use of its
antidepressant paroxetine (Paxil) in children.

The human stakes in this case are considerable, because
researchers elsewhere have raised serious concerns that some
antidepressants might actually increase the risk of suicide in
children. Moreover, about 2.1 million paroxetine prescriptions were
written for children in 2002.

Mr. Spitzer alleges that the drug manufacturer skewed information
about paroxetine by widely disseminating the single study that was
able to showcase the drug in a positive light. He charges Glaxo with
suppressing four other studies conducted on children and adolescents
in the late 1990s that found paroxetine to be either ineffective or
suspect for increasing the potential risk of suicide.

According to the Associated Press, the lawsuit also exposes an
internal Glaxo document indicating that the company intended to
"manage the dissemination of data in order to minimize any potential
negative commercial impact."

In summing up his mission, Mr. Spitzer succinctly stated his
case: "Having doctors prescribe drugs without full knowledge of
safety and efficacy is wrong."

Iapplaud Mr. Spitzer's efforts to drive out the forces that
wittingly and unwittingly obscure or manipulate the information we
need to evaluate the safety and efficacy of drugs. But he will need
a good many deputies to help him.

Because the vast majority of drug trials are currently funded by
the pharmaceutical companies, he will have to persuade that industry
of the merits of his mission. If he's lucky, federal regulators like
the FDA will be armed with reporting requirements and riding at his
side. Perhaps he can commandeer the public wagons to circle tight
around the research industry, closing in with demands that it
consistently reveal and disseminate all drug trial information --
whether it is good, neutral, or bad.

Hopefully, the medical community will posse up en masse. So far,
the American Medical Association and the publishers of a dozen major
medical journals have called for proposals that require drug
companies to register their studies in a central database at the
outset of their trials. We could go further and decline arrangements
with drug companies that allow them to own or silence the results of
the research trials they fund.

Meanwhile, Mr. Spitzer's move is bold and courageous. It gives me
hope that we may be nearing high noon in New York, about to witness
an overdue showdown between the commercial interests of the drug
marketplace and the health interests of humanity that drug science
should serve.

Kate Scannell is a physician with Kaiser Permanente and the
author of "Death of the Good Doctor."

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