E-DRUG: Full Drug Trial Disclosure
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[To avoid publication bias of "positive" clinical trials, there have been
several proposals to set up a compulsory system of CT registries. Several
countries already have such plans. Now also the USA starts discussing.
Also note the message that GSK has put all(?) clinical data on depression in
youth on its website!
E-drug found them at http://www.gsk.com/media/paroxetine.htm
Copied as fair use from today's New York Times. WB]
June 15, 2004
Group Weighs Plan for Full Drug-Trial Disclosure
By BARRY MEIER
An organization of top medical journals is considering a proposal that would
require drug makers to register clinical trials at their start in a public
database in order for results, whether successful or not, to be later
considered for publication, according to three people working with the
group.
Pharmaceutical companies are not generally required now to disclose
results of a trial or even whether one was conducted. Some academic
researchers have long argued that fuller registries of drug trials are
needed because companies, as well as medical journals and scientists, tend
to spotlight only trials that show positive results.
The plan, if adopted by the organization, the International Committee of
Medical Journal Editors, is likely to put pressure on pharmaceutical
makers to disclose more about the trials they run. The group includes 12
major medical journals like The Journal of the American Medical
Association, The New England Journal of Medicine, The Lancet and The
Annals of Internal Medicine.
The recent discussion among the journal editors about a trial registry
comes amid public controversy about clinical trial data after the
disclosures that the results of antidepressant tests in children were not
adequately publicized.
Because the medical journals in the group are prestigious, and publication
of the results of a clinical trial in them carries much weight, companies
frequently use articles from them as marketing tools to persuade doctors
to prescribe a drug. If the International Committee of Medical Journal
Editors adopts the proposal for a registry, drug companies not wanting to
participate could still seek to have their research published in other
less-prominent medical journals, but the research might not get as much
attention from physicians.
A spokesman for the Pharmaceutical Research and Manufacturers Association
of America, a group representing drug makers, said it was not aware of the
proposal being considered by medical journal editors to require
registration of trials, so it could not comment on it. In the past, the
group has not supported a registry, although a few companies have adopted
a registry.
Many drug companies without registries have noted that they voluntarily
disclose the results of all clinical trials they conduct, either at
scientific conferences or through publications.
But critics say that there is no central registry where clinical trials
and their results are available, making it difficult for researchers to
track all studies that have been done on a single drug.
Ideally, advocates of clinical trial registries say, such databases would
show when a trial was started, list its objectives and then update that
information with the trial's results or the reason it was terminated.
A proposal to mandate trial registration as a prerequisite for publication
was discussed last week at a meeting of the journal editors' group, said
the three people working with the organization who insisted on anonymity
because, they said, the proposal was still under discussion and because
the group was not planning to announce any change unless it was adopted.
A decision could come in the summer, one person said.
In a related development, policy makers at the American Medical
Association, which represents many of the nation's doctors, are expected
to vote as early as today on a proposal that would urge the government to
create a public registry of clinical trials and their results, a spokesman
for the A.M.A. said.
Yesterday, GlaxoSmithKline, the manufacturer of the antidepressant Paxil,
released on its company Web site the reports of clinical tests of that
drug in children and adolescents suffering from psychological conditions
including depression.
The action follows a civil lawsuit filed this month by the New York State
attorney general, Eliot Spitzer, that accused the company of misleading
doctors by publicizing a favorable study of Paxil for pediatric depression
while playing down other trials that showed the drug did not work better
than a placebo.
GlaxoSmithKline officials have denied that they selectively disclosed
trial findings.
Regulators in this country and elsewhere are now scrambling to review
unpublished test data on Paxil and several other popular antidepressants
to see if the drugs pose dangers.
In a statement issued yesterday, Mr. Spitzer said that the company's
actions had not resolved his lawsuit but called it a positive move. "This
is a positive first step toward changing a dangerous industry practice,"
he said.
A decision by the International Committee of Medical Journal Editors to
consider for publication only clinical trials that have been registered
from the start would be the organization's latest effort to push for
greater disclosure of data.
Two years ago, the group published a joint editorial calling on companies
to provide university researchers with a greater role in designing trials
and access to the analysis of results. That same editorial also pointed to
the fact that the results of some trials were never published.
"The results of the unfinished trial may be buried rather than published
if they are unfavorable to the sponsor's product," the editorial stated.
"Such issues are not theoretical. There have been a number of recent
public examples of such problems, and we suspect that many more go
unreported."
But some academic researchers have also argued that medical journals are
themselves part of the problem, even if unwittingly so. A growing number
of studies have found that clinical trials published in leading medical
journals tend to show positive results about the drug or medical devices
being tested, a phenomenon referred to as publication bias.
As a result, those researchers say, physicians who rely on medical
journals for information about drugs and medical devices may get an
incomplete view of their effectiveness or safety because they may be
unaware of other less favorable or inconclusive studies.
In an interview this month, Dr. Alan Goldhammer, associate vice president
for regulatory affairs for the Pharmaceutical Research and Manufacturers
Association of America, said that to date the organization had not
supported the idea of a public registry for clinical trials. He said the
association might reconsider its stance in light of the antidepressant
controversy.
Another trade group, the Association of the British Pharmaceutical
Industry, recommended to its members last year that they voluntarily
create trial registries. A spokesman for the group said recently that 8 of
its 80 members had created such databases.
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