E-drug: Comment on draft WHO guidelines
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Dear E-drug readers,
We, three of the members of the editorial committee and editorial staff
of Rinsho Hyoka (Clinical Evaluation), a Japanese medical journal, sent
a comment to the draft WHO guidelines, for which WHO invited public
comments. We've sent the comment as follows with CC e-mails to
regulatory authorities of EU, USA and Japan, and the well known
media in the world.
I would like to offer the comment also to E-drug readers.
Chieko Kurihara
Editorial staff of Rinsho Hyokia (Clinical Evaluation)
e-mail: CZQ02362@nifty.ne.jp
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Dr. Denis Aitken
Senior Policy Advisor
Chairman, Committee on Private Sector Collaboration
World Health Organization
CH-1211 Geneva 27, Switsland
30 December 1999
Dear Dr. Aitken,
We, three are members of editorial committee and an editorial staff of
the Rinsho Hyoka (Clinical Evaluation), a medical journal dealing with
clinical trials conducted in Japan and in the world, which was
established in 1972, early time of the history of clinical trials in Japan.
We wish to comment to the WHO draft Guidelines on Interaction with
Commercial Enterprises, as we found in the Health Action International
(HAI) web-site that you are inviting public comments before the end of
December 1999. The following comment is based on the individual
ideas of the three persons whose names are put down at the bottom
of this letter. The editorial policy of our journal is to work for fairness
and quality assurance of clinical trials in Japan. As tax payers as well
as strong believers of principles of fairness and quality assurance, we
especially want to comment to the items 3.4 and 4.1 of the draft
which mention about acceptability of donation from or propriety of
collaborative work with a company when WHO is concerned in the
clinical trial.
According to the items 3.4 and 4.1, the idea of the draft guidelines is
that the trials should be conducted for public health interest and in
conformity with internationally accepted technical and ethical
consideration, and the final products must be made widely available at
a preferential price. It is correct, but the important thing is how this
whole process is quality-assured, including acceptability of cash
donation. We hereby wish to request that all the process of discussion
and monitoring by WHO's Ethics Committee / IRB should be disclosed
in real time so that the validity of donation from or collaborative work
with company could be judged by the public. We request inclusion of
this idea / sentence in the final guideline, because of the following two
reasons;
Firstly, the ethical guidelines themselves are now in the process of
discussions for revisions as is seen in the case of the Declaration of
Helsinki.
A round-table discussion in our journal, Rinsho Hyoka, titled "Ethics in
clinical trial in the days of globalization of drug development" (Rinsho
Hyoka 1999; 26(3): 341-417. Robert Levine, Kiichiro Tsutani and
Tadahiro Mitsuishi are in the participants of the discussion. We sent
this issue of journal to you under separate cover.) shows that there
are various opinions on ethical issues in the trial protocol and its
execution when it is sponsored by industrial countries with the
subjects in developing countries. And also it shows that even though
a trial seems to be conducted in conformity with international ethical
documents, it is often questioned how ethical guidelines themselves
were constructed and interpreted and should be revised if needed.
Secondly, conflict of interests among WHO, a company and
investigators may cause biases to the outcomes of the trial.
The article titled Conflict of interest in the debate over calcium
channel antagonists (NEJM 1998; 338: 101-106), concludes the
necessity of disclosure of information to avoid the biases to the
outcomes of trials because of conflicts of interests between
companies and investigators who report the trials. (The Japanese
translation of this article by Tadahiro Mitsuishi is published on the
Rinsho Hyoka 1999; 26(3): 505-515, which can be found in the same
issue we sent to you.)
From the above point of view, we believe that disclosure of
information on clinical trial jointly conducted by WHO and industries is
crucial. By means of this, acceptability of donation from or propriety
of collaborative work with a company will be judged also by the public
during all the process of the trials.
We hope that you revise the draft guideline, including our comments,
then it will win the support of the people working for public health and
rational drug use, all over the world.
Regards,
Tadahiro MITSUISHI, attorney-at-law,
Editorial board member of the Rinsho Hyoka (Clinical Evaluation)
Kiichiro TSUTANI, M.D.,Ph.D
Editorial board member of the Rinsho Hyoka (Clinical Evaluation)
Chieko KURIHARA
Editorial staff of the Rinsho Hyoka (Clinical Evaluation)
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