he debate over the disclosure of
clinical drug trials could reach a turning point this week, with
editors of influential medical journals expected to call for
fundamental changes in the way such tests are reported.
The journal editors, gatekeepers for the medical profession, are
expected to begin requiring that drug trials be registered at the
outset as a prerequisite for the subsequent publication of their
results. Requiring such registration as a condition for reaching the
journals' vast audience of doctors would make it difficult for drug
companies to hide the results of unflattering tests - as some have
been accused of doing.
The journal editors declined yesterday to discuss the new policy
before the announcement, but the group said several months ago that
it was considering such a step.
Details of the policy by the group - which includes prestigious
publications like The Journal of the American Medical Association,
The New England Journal of Medicine, The Lancet and The Annals of
Internal Medicine - are to be presented Thursday at a House Commerce
subcommittee hearing on disclosure of data from pediatric trials of
antidepressants.
Meanwhile, both House and Senate Democrats say they expect to
introduce legislation as early as Thursday that would require drug
trials involving human subjects to be registered in a public
database before the tests were allowed to proceed.
Congressional Republicans, though, have not announced any plans
for such legislation. And an official of the drug industry's trade
group, which yesterday announced a voluntary plan to disclose trial
results, said his organization thought that legislation was not
necessary.
Some academic researchers have long argued that drug companies
unduly influence medical practice by highlighting positive trial
findings while not publishing negative ones. The subject gained
public prominence earlier this year with the disclosure that
unpublished test data from trials of some widely used
antidepressants had indicated that some adolescents and children who
took the drugs had a greater tendency toward suicidal thoughts than
those given placebos.
"People have been concerned for quite some time that
nondisclosure of unfavorable studies has skewed the scientific
literature and possibly medical practice," said Dr. Ronald M. Davis,
a trustee of the American Medical Association. "But recently,
tangible evidence of that concern has arisen."
Makers of antidepressants have denied concealing any data. But in
recent months, they and other drug producers have scrambled to
address criticism about disclosure in the industry of trial results.
Three leading companies, GlaxoSmithKline,
Eli Lilly and Merck
have recently announced plans under which they would provide more
public information about their drug tests and the results.
Yesterday, the industry trade association, the Pharmaceutical
Research and Manufacturers of America, said it was creating a Web
site on which its members could voluntarily post the results of
trials of their medications.
Also yesterday, the New York State attorney general, Eliot
Spitzer, said in a telephone interview that his office had reached
an agreement with another drug maker, Forest
Laboratories, for it to disclose the results of clinical trials.
Mr. Spitzer had sought information from Forest about how it marketed
and disclosed test results for its antidepressant Celexa and other
drugs, but his office has not begun a formal investigation or
accused the company of wrongdoing.
This past spring, Mr. Spitzer sued GlaxoSmithKline, contending
that it misled doctors by playing down negative pediatric test
information about its popular antidepressant Paxil. And soon
thereafter, the American Medical Association called for the federal
government to create a database in which drug companies would be
required to register clinical tests of their medications at the
outset and report the results.
In June, the group from the medical publications, calling itself
the International Committee of Medical Journal Editors, said it was
considering requiring companies to publicly register tests in order
for them to be published later.
Yesterday, two journal editors declined to discuss the details of
that plan before its public release on Thursday. But both editors
said they supported calls for mandatory drug trial registration and
reporting, apparently signaling by their comments that the group
planned a major shift in publication policy.
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