AMA's efforts to publish results
of all studies are long overdue
By Arthur Caplan,
Ph.D.
COMMENTARY
Updated: 1:43 p.m. ET June 22,
2004
Listen very carefully. Do you hear the sounds of ice
cracking in the fiery domain where sinners are said to go upon their
deaths? Has hell in fact frozen over? Can it be true? Has the
American Medical Association broken away from a long history of concern about
protecting its members' self-interest and pushed forward an idea that is sound,
bold and in the public interest? Hell, yes!
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On
June 17, the AMA voted to ask the federal government to create a registry that
would make publicly available the results of all drug experiments conducted on
humans. This means that anyone could look and see what drugs have worked, which
ones are duds and which ones are known to have possibly dangerous side
effects.
Limited access to
information Such a move would help solve the problem of limited
access to accurate drug information in the United States, an issue that stems
from several sources. First off, academic researchers have a hard time getting
research published if it does not show positive results. Negative studies don’t
get past most journal editors. Even if experiments that don’t pan out do get
published in the academic literature, you are not likely to hear about it.
"Common cold still not cured" is a headline you are unlikely to ever read.
More troubling than the problems academic researchers
have in getting negative results published is the behavior of private companies
that sponsor studies.
Pharmaceutical and biotechnology companies sponsor the
overwhelming majority of late-stage tests of new drugs and medical devices. Even
if private drug companies know there are negative results — or even injuries and
deaths — associated with their products, they are under no obligation to make
that information known to you or the medical profession. The companies consider
this data proprietary. They have lobbied to ensure that only the Food and Drug
Administration gets this information and, even then, some drug companies simply
prematurely squash studies they don’t think will reflect favorably on their
product.
The most recent
example of hiding negative results concerns children. Studies conducted by drug
companies showed evidence linking the use of antidepressant drugs to an
increased risk of suicide in children. But the pharmaceutical companies chose
not to disclose this evidence. It was only when Elliott Spitzer, New York
State’s take-no-bull attorney general, began hauling the offending drugs
companies into court that the damaging evidence was released.
The physicians of the AMA realized that without ready
access to all experimental data — good, bad and indifferent — they cannot hope
to know what is the best treatment for their patients. And they also
understand that without public access to negative data all they can go on is
what the marketing departments of the drug companies tout as the best drug to
prescribe.
Broken contracts There is
another reason to make sure that every bit of data produced in testing new drugs
and devices on human beings is made public: It is part of the tacit contract the
researcher and sponsor of the study have with each and every subject.
If you agree to be in an experiment or to participate in
a clinical trial to find new ways to treat your cancer, diabetes, Parkinsonism,
asthma, depression, migraines or whatever, you are told that the chance of
directly benefiting from your participation in a study is at best unknown.
Research simply often does not pan out. But, you are also told that if you
choose to enter a study then even if it does not work, and most studies do not,
doctors will learn from the results and future generations will benefit from
that knowledge.
That is a great reason to participate in medical
research. But if negative results are not published, if bad outcomes or deaths
are swept under the rug, then nothing is learned. And the promise that was
made to those who put up with the risk, inconvenience and hassle of research is
broken.
Medicine will be much much better off if commercial
concerns take a back seat to society's need to know. All data from every
experiment — regardless of who pays for it — should be kept in a national
registry that is accessible to anyone who wants to see it. Not just because such
a registry will make medicine more effective, cheaper and safer, but also
because it is what every subject in a medical experiment has the right to
expect.
Arthur Caplan is director of the Center for Bioethics
at the University of Pennsylvania.
