This is indirectly very important for the evidence base, and so relevant
to much of what we do.
Andrew Herxheimer
Emeritus Fellow, UK Cochrane Centre
9 Park Crescent, London N3 2NL UK
Phone: +44 181 346 5470
Fax : +44 181 346 0407
e-mail: [log in to unmask]
-------------Forwarded Message-----------------
From: Peter Lurie, INTERNET:[log in to unmask]
Date: 15/06/99 00:15
RE: Declaration of Helsinki still threatened
This is to update everyone on developments since we first contacted you and
alerted you to proposed changes in the Declaration of Helsinki that would
threaten the rights of research participants, particularly those in
developing countries. These changes would expand the use of placebos and
allow researchers to deny poor participants, particularly in developing
countries, effective medical therapy. The information below is stitched
together from a number of emails and phone calls I have made in the last
month or so. Unfortunately, due to the closed nature of the debate on these
issues, it has taken this long to come up with adequately corroborated
information. PLEASE POST THIS INFORMATION ON ALL APPROPRIATE LISTSERVES AND
FORWARD IT TO INTERESTED COLLEAGUES.
Already, by simply airing our concerns and making the proposed changes
public for the first time, we are having an impact. Some of the proposed
changes have come under criticism in the Lancet (Declaration of
Helsinki--nothing to declare? Lancet 253, April 17, 1999) and the process
seems to have been delayed, at the least. But this is certainly not the
time to relax.
IF YOU HAVE NOT ALREADY DONE SO, WE INVITE YOU TO BECOME A PART OF AN
INTERNATIONAL CAMPAIGN TO PROTECT THE RIGHTS OF STUDY PARTICIPANTS BY SENDING
AN EMAIL TO [log in to unmask] We will continue to provide updated
information to you as we receive it and to plan a coordinated strategy to
defend participants' rights.
The information in this email is arranged in seven sections:
a. Declaration of Helsinki
b. CIOMS document
c. UNAIDS vaccine document
d. "Consensus" statement on perinatal trials in the Lancet
e. Unethical US studies on Haitian HIV-positive patients
f. Access to draft ethics documents and prior Public Citizen publications
g. What you can do
a. Declaration of Helsinki
The Council of the World Medical Association met in Chile in early April to
discuss the proposed revisions to the Declaration of Helsinki. From what we
have been able to learn, it appears that debate was vigorous, particularly
over the elimination of the distinction between clinical and non-clinical
research. Much of the resistance came from Britain, Japan and South Africa.
It is not clear whether the other important issues (e.g., expanded use of
placebos, denial of effective therapy based on poverty) were discussed at
any length. No votes were taken. In any event, the draft document that we
previousy circulated was not adopted for recommendation to the WMA General
Assembly, which meets in Tel Aviv from October 13-17, 1999. This is made
clear in a letter in Lancet by Delon Human of the WMA who said: "This draft
will not ... be considered at the WMA's annual general assembly in Israel in
October, 1999" (Lancet 1999;353:1285).
Instead, a new working group will seek more input from the National Medical
Associations (NMAs). The members of this working group are Dr. Kazimierski
(sp.?) from Canada, Dr. Millimacki from Finland and Dr. Dickey from the USA.
It will then use the existing Declaration, the proposed changes and the
comments from the NMAs to decide how to proceed. This new working group
will present its proposal to the Medical Ethics Committee, which makes
recommendations to the WMA Council, which can pass the document on to the
full Assembly for a vote. It is not clear whether this can be accomplished
in time to have a revised version of the Declaration available for the full
Assembly to vote on in October, as the NMAs have been given six months to
seek input from physicians in their countries.
b. CIOMS document
The process for revising the Council of International Organizations for
Medical Sciences (CIOMS) document, is even more closed. We have not yet
been able to obtain a copy of the proposed changes to CIOMS. Officials in
Geneva have refused to provide information on the status of the revisions or
who is involved in revising the document, let alone what the content might
be. This is inappropriate, to say the least, for any international ethics
document.
However, we have been able to learn that there was a meeting of the Steering
Committee in Geneva in early May at which a draft document was discussed.
This draft, like the proposed revisions to the Declaration of Helsinki and
the UNAIDS vaccine trial ethics document, was written by Dr. Robert Levine
of Yale. Perhaps it is no surprise that it appears to make the same basic
changes as the other documents: the loosening of the provisions on placebo
use and the institutionalisation of double standards based on economics.
Apparently, there was a lot of concern on the international justice issues.
Those voicing such concerns were KS Kahn from Pakistan, Solomon Benatar from
South Africa and Florencio Luna from Argentina. IF ANYONE CAN PUT US IN
CONTACT WITH DRS. KAHN AND BENATAR (WE HAVE LOCATED DR. LUNA), IT WOULD BE
VERY HELPFUL. ALSO, WE MUST CONTINUE OUR EFFORTS TO OBTAIN A COPY OF THE
CIOMS DOCUMENT TO ENSURE A TRULY OPEN DISCUSSION OF THESE ISSUES.
According to one version of what occurred at the meeting, the next step is
to make changes in the draft document based on the recent meeting and for
the Steering Committee to commission papers on various key topics, including
international justice. It is not clear at this time who will write these
papers, but Sam Gourevits and Robert Levine are among those commissioning
the papers. There will then be a large (perhaps 100 person) meeting in
Geneva in December at which these papers will be discussed. The document
will be further revised after the meeting and then sent to CIOMS to
finalise. Other accounts of the meeting make this schedule seem more
tentative. It is not clear that there is any process for public input,
although apparently some have advocated strongly for this.
c. UNAIDS vaccine document
As mentioned previously, the UNAIDS program is currently developing ethics
guidelines for HIV vaccine trials. This is, of course, a little late in the
day, as Vaxgen has been conducting a study among injection drug users in
Thailand for some months. They do not plan to provide sterile syringes to
the participants, nor will they guarantee optimal antiretroviral therapy to
participants who become infected during the trial.
In developing their guidelines, UNAIDS held a series of meetings in
Switzerland, Uganda, Brazil, Thailand and the USA. Now, in part because of
criticism from Public Citizen and others that the most recent draft
(November 1998) did not adequately reflect the lack of consensus on many
issues, particularly researchers' obligation to treat participants who
contract HIV infection during the trial, UNAIDS has decided not to release a
consensus document at all. Rather, it will release a document, based on the
October draft, under the name of UNAIDS. This makes a mockery of the entire
consultation process. The outcome is a foregone conclusion. Robert Levine
is currently working on the latest draft and UNAIDS could release it any
day.
d. "Consensus" statement on perinatal trials in the Lancet
On March 6, 1999 a so-called "consensus statement" on perinatal HIV research
was published in the Lancet (Lancet 1999;353:832-5). This was based upon a
meeting convened in Atlanta by scientists who had defended the use of
placebo in perinatal studies in Africa and Thailand. Public Citizen and the
New England Journal of Medicine, which together raised the criticisms of
these studies in the first place, were not invited. The statement concluded
that it is ethical, even today after less-expensive regimens of AZT have
been proved to reduce perinatal HIV transmission, to conduct
placebo-controlled trials as long as the developing country is so poor that
it cannot provide even the less expensive regimen of AZT.
A series of letters, all condemning the statement, were published in
response (Lancet, 29 May, 1999). One letter, by Dirceu Greco of Brazil,
pointed out that there was much disagreement over the supposed consensus
reached at the meeting. Public Citizen's letter referred to the
multipronged assault on research ethics currently underway.
e. Unethical US studies on Haitian HIV-positive patients
Recently, the New York Times ran a front page story on the failure of
Cornell University researchers to provide antiretroviral drugs to
HIV-positive patients in US-funded research in Haiti. The researchers went
so far as to decline an offer of free drugs from France. The Haitian IRB
included researchers' family members. Questions were raised about the
quality of HIV prevention counseling provided to the participants. And so
forth. Shortly thereafter, the Times published two letters, including one
from Public Citizen raising the draft changes in the Declaration of Helsinki
for the first time before the lay public. These letters are reproduced
below.
To the Editor:
Re "For Subjects in Haiti Study, Free AIDS Care Has a Price" (front page,
June 6): You quote a Haitian Medical Association official's description of
the AIDS researcher Dr. Jean William Pape: "If he had to choose between the
survival of 10 people and the survival of a nation, he would probably choose
the survival of a nation." This statement is a measure of our medical and
public health establishment's failure to provide a grounding in the ethics
of research. The fact that it was meant to praise Dr. Pape demonstrates how
abject that failure has been.
Presumably, Dr. Pape and his Cornell Medical College colleagues all once
worked for the survival of individuals, not nations. We have failed if
doctors and researchers can no longer recognize that their
wagers on a future AIDS vaccine are covered with the lives of real people.
PHILIP ALCABES
Bronx, June 8, 1999
To the Editor:
Even after less expensive regimens of the drug AZT that are designed for
poor countries have been proved to reduce H.I.V. transmission from mother to
infant, this regimen is still unavailable to most
people who could benefit from it, including residents in the countries that
were host to the trials (front page, June 6). The National Institutes of
Health is supporting a new generation of mother-infant studies in southern
Africa in which the less expensive regimens are still not being provided.
The international research community has responded to criticisms of studies
in which effective therapy is withheld by trying to rewrite governing ethics
documents. Yet instead of mandating that participants receive the best
proven therapeutic method, a proposed revision to the Helsinki Declaration
by the World Medical Association would mandate the treatment only
if it "would otherwise be available."
PETER LURIE , M.D.
Washington, June 7, 1999
The writer is a medical researcher at Public Citizen.
f. Access to draft ethics documents and prior Public Citizen publications
We understand that some of you had difficulty downloading Public Citizen's
comments in the past. Consequently, we include new web addresses for these
documents as well as ways to get other documents.
UNAIDS HIV vaccine document (November 1998): available only in hard copy.
Contact Public Citizen or UNAIDS (Jose Esparza, MD, PhD. Team Leader,
Vaccines, Department of Policy, Strategy and Research, Joint United Nations
Programme on HIV/AIDS, 20, avenue Appia, CH-1211 Geneva 27, Switzerland) for
this document
Public Citizen's comments on the UNAIDS document can be found at:
http://www.citizen.org/hrg/PUBLICATIONS/1471.htm
Proposed changes to the Declaration of Helsinki: The British Medical
Association has posted a notice soliciting comments on the Declaration of
Helsinki on their website:
http://web.bma.org.uk/public/ethics.nsf/htmlpagesvw/WMAnews
This also includes links to the current and proposed Declarations
Public Citizen's comments on the proposed changes to the Declaration of
Helsinki can be found at: http://www.citizen.org/hrg/PUBLICATIONS/1477.htm
g. What you can do
1. We urgently need copies of the draft CIOMS document. Please do your
utmost to contact anyone you know to be involved in the revision. Please
also send us the names of anyone you know to be involved.
2. The action with regard to the Declaration of Helsinki seems to have
shifted to the NMA level. Public Citizen has obtained a list of names and
addresses for all WMA member organizations and will shortly be mailing out
our comments to each group. Please write to your NMA, with cc's to the WMA
(Dr. Delon Human, World Medical Association, 28 Avenue des Alpes, 01212
Ferney-Voltaire Cedex, France; Fax: 011-33-4-50405937) and Public Citizen
(Peter Lurie, Public Citizen, 1600 20th St., NW, Washington, DC 20009; Fax:
(202)588-7796; email: [log in to unmask]). If you do not have your NMA's
address, please contact Public Citizen. Generating articles in your
national medical journals and lay press is also critical.
3. Please post this message on appropriate listserves and forward to
interested colleagues.
4. Sign up for this campaign to protect the international ethics documents
by sending an email to Peter Lurie at [log in to unmask]
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: [log in to unmask]
Website:http://www.citizen.org/hrg/
----------------------- Internet Header --------------------------------
Sender: [log in to unmask]
Received: from elwood.cais.com (elwood.cais.com [199.0.216.215])
by hil-img-5.compuserve.com (8.8.6/8.8.6/2.19) with ESMTP id TAA09493
for <[log in to unmask]>; Mon, 14 Jun 1999 19:15:07 -0400 (EDT)
Received: from mail.citizen.org (mail.citizen.org [207.226.63.141])
by elwood.cais.com (8.9.1/Elwood) with SMTP
id CAA07921; Tue, 15 Jun 1999 02:54:22 -0400 (EDT)
Received: from Connect2 Message Router by mail.citizen.org
via Connect2-SMTP 4.01.b28; Mon, 14 Jun 1999 19:18:57 -0500
Message-ID: <[log in to unmask]>
Date: Mon, 14 Jun 1999 19:09:00 -0400
From: Peter Lurie <[log in to unmask]>
Sender: Peter Lurie <[log in to unmask]>
Organization: Public Citizen
To: [log in to unmask] (Peter Lurie)
Subject: Declaration of Helsinki still threatened
MIME-Version: 1.0
Content-type: text/plain; charset="US-ASCII"
Content-transfer-encoding: 7BIT
X-Mailer: Connect2-SMTP 4.01.b28 MHS to SMTP Gateway
%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%
|
