E-drug: CIOMS ethics document
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Dear colleagues,
Following Public Citizen (Peter Lurie)'s invitation to comment on the
CIOMS ethics document, the International Society of Drug Bulletins
(ISDB) sent a message to Dr Jack Bryant. Note that this so-called
Council for International Organizations of Medical Science is a
subsidiary of the World Health Organization.
Christophe Kopp
Chairman, ISDB
Staff editor, la revue Prescrire
PO Box 459
75527 Paris cedex 11
France
phone 33 1 47 70 86 06
fax 33 1 47 70 52 04
christophe.kopp@wanadoo.fr
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Dr. Jack Bryant
President
Council for International Organizations of Medical Sciences
c/o World Health Organization
CH-1211 Geneva 27
Switzerland
Fax: (41-22) 791 31 11
Email: cioms@who.ch
Dear Dr. Bryant,
The International Society of Drug Bulletins (ISDB) has welcomed the
gains provided by the October 2000 version of the World Medical
Association's Declaration of Helsinki. As shown by Public Citizen,
the revised version of the Council for International Organizations of
Medical Sciences (CIOMS) International Ethical Guidelines for
Biomedical Research Involving Human Subjects is far from meeting
the legitimate requirements of the Helsinki Declaration.
To Public Citizen's comments we would add the following:
1. The working method that led to this draft, i.e. secret procedures
and lack of public input, is unworthy of a body with close links to
the World Health Organization.
2. The CIOMS draft has no provision on publication obligation such
as stated in provision 27 of the Helsinki Declaration: "Negative as
well as positive results should be published or otherwise publicly
available". This provision underlines the possibility to limit
publication bias and carry out reliable meta-analysis and reviews.
Without such a possibility health professionals could overestimate
the true impact of new treatment methods. This provision also
recognises the just claim of patients participating in clinical trials to
access study reports.
Christophe Kopp, ISDB Chairman
Maria Font, ISDB General Secretary
Andrea Tarr, ISDB Treasurer
The International Society of Drug Bulletins (ISDB) is a worldwide
network of over 50 bulletins and journals on drugs and therapeutics
that are financially and morally independent of the pharmaceutical
companies. ISDB members are concerned about the increasing
influence of transnational corporations on regulatory authorities and
the World Health Organization.
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