E-drug: Declaration of Helsinki - urgent - action needed
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September 29, 2000
The World Medical Association has recently released the current draft
of the Declaration of Helsinki. It is available on the WMA website
at www.wma.net. The WMA meeting is taking place from October 3-7 in
Edinburgh. The current draft will be discussed informally tomorrow
(Saturday the 30th). On Tuesday the 3rd, it goes to the Medical
Ethics Committee, on Friday morning the 6th it goes before the WMA's
Council and that afternoon to the full WMA Assembly, which must
ratify it for it to be adopted.
The Declaration is, in most respects an improvement over all previous
drafts and even the current Declaration itself. In particular, the
phrase "best proven prophylactic, diagnostic, and therapeutic
methods" (describing what must be provided to patients in clinical
trials) is now in the draft Declaration (the previous version left
out the word "best"). This is a great victory for the dozens if not
hundreds of us who have commented on the dangers of deferring to
local "standards of care" instead of scientific standards. However,
perhaps inadvertently, this phrase is now followed by the phrase "at
the conclusion of the study." The result is that what is "best" must
now be provided at the conclusion of the study (a good idea, but one
that is now handled well elsewhere in the document) and the draft
Declaration is now silent on what must be provided during the trial,
the very issue that raised so much controversy in the first place.
Researchers will be left with a literal carte blanche as to what to
provide during the trial - and we have seen what was provided in the
perinatal AZT trials even when the Declaration precluded it
(placebos, for all-too-many patients).
We have written a letter to the WMA expressing our concerns on this
issue. It is available on our website at
www.citizen.org/hrg/PUBLICATIONS/1538.htm
We urge you to post this notice on all relevant listserves. IT IS
NOT TOO LATE TO WRITE A BRIEF NOTE EXPRESSING YOUR CONCERNS TO THE
WMA. The best way would be by email to Dr. Delon Human of the WMA at
delon@wma.net. You could also fax the WMA at 33-4-50405937, but it
is not clear if they will receive it in time. Please cc me on
anything you write.
Thank you all once again for your efforts in this extremely important
project. If we can take care of this problem, we will collectively
have accomplished a great deal in protecting the rights of
participants in research.
Peter Lurie
Peter Lurie, MD, MPH
Deputy Director
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org
Web address: http://www.citizen.org
[Peter added an attachment but attachments don't work on 'lists'. If
you cannot access the website, please contact him direct for the
details. BS]
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