Medical editors to block publication of research if
sponsors control trials
The problem of the pharmaceutical industry influencing
clinical trials has been raised by editors of leading international medical
journals.
The International Committee of Medical Journal Editors
(ICMJE) has strengthened its guidelines so that research will not be published
when it has been conducted under conditions where the sponsor (usually
a pharmaceutical company) has sole control of the data or has the capability
to withhold publication if the results are unfavourable. Journals signed
up to the new guidelines include the BMJ, The Lancet, the
Journal of the American Medical Association and the New England
Journal of Medicine.
In the BMJ, editor Richard Smith says: “We
editors of medical journals worry that we sometimes publish studies where
the declared authors have not participated in the design of the study,
had no access to the raw data, and had little to do with the interpretation
of the data. Instead the sponsors of the study — often pharmaceutical
companies — have designed the study and analysed and interpreted the data.”
He continues: “Editors are also concerned that the declared authors might
not have ultimate control over whether their studies are published. That
decision may rest with the funders of the research — perhaps a government
department or pharmaceutical company — which could mean that results unfavourable
to the funders are suppressed.”
In The Lancet, a leading article signed by
editors of 11 international medical journals explains that economic pressures
are the underlying reason for the problem. “We strongly oppose contractual
agreements that deny investigators the right to examine the data independently
or to submit a manuscript for publication without first obtaining the
consent of the sponsor,” they say.
Under the new guidelines, authors will be required
to disclose details of their own and the sponsor’s role in the study.
Many of the journals will ask authors to sign a statement indicating that
they accept full responsibility for the conduct of the trial, had access
to the data and controlled the decision to publish.
“This initiative should not be seen as an attack
on the pharmaceutical industry,” the BMJ adds. “Almost all new
drugs are developed by the industry, and many companies have high ethical
standards and will see no problem in complying with the new policies.
Other groups including hospitals and governments may often be keen to
control publication especially if the results appear to contradict current
policy.”
Leading articles will be published simultaneously
this week by journals that are members of the ICMJE (BMJ 2001;323:588
and Lancet 2001;358:854).
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