E-drug: Draft revisions to Declaration of Helsinki
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Attached (Not attached, see comment at the end. Moderator) you will find
proposed revisions to the World Medical Association's Declaration of
Helsinki. This document has been drafted in advance of the WMA's Council
meeting in Santiago, Chile on April 15, 1999. Depending on its reception
there, it could be forwarded to the full WMA meeting in Israel in October 1999.
The document is a significant dilution of hitherto accepted human subjects
protections. In particular, it provides for the withholding of effective,
even lifesaving, therapy if the therapy is not available in the country in
which the study is taking place. It also permits the provision of placebos
for conditions with known effective therapies anywhere in the world, as long
as the condition does not cause death or disability.
You will also find attached (Not attached, see comments at the end.
Moderator) comments criticising the draft Declaration by myself and Sidney
Wolfe of Public Citizen's Health Research Group on these provisions. The
draft declaration is in Word for Windows; our comments are in Word Perfect.
The latter can also be downloaded from Public Citizen's website at
http://www.citizen.org/hrg/WHAT’SNEW/1777.htm
Our understanding is that the draft Declaration has been circulated to
member medical associations but not widely outside of that group. WE
THEREFORE URGE YOU TO CIRCULATE THIS EMAIL AND THE TWO ATTACHMENTS AS WIDELY
AS POSSIBLE, TO OPEN UP THE PROCESS.
Unfortunately, we were only recently able to obtain a copy and comments were
due yesterday (March 29). However, Public Citizen will continue to monitor
this process as it evolves. IF YOU ARE INTERESTED IN PARTICIPATING IN AN
INTERNATIONAL CAMPAIGN TO RESIST THE DOWNGRADING OF HUMAN SUBJECTS
PROTECTIONS, PLEASE SEND ME AN EMAIL AT plurie@citizen.org and we will keep
you involved as the process goes forward.
Peter Lurie, MD, MPH
Public Citizen's Health Research Group
1600 20th St., NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org
Website:http://www.citizen.org/hrg/
[Note from moderator: Anyone interested in the draft, please contact Peter
Lurie directly. This because it is long and because not all of you (me
included) are able to decode a MIME document. Kirsten Myhr]
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