Rapid responses are electronic comments to the editor. They enable our users
to debate issues raised in articles published on bmj.com. A rapid response
is first posted online. If you need the URL (web address) of an individual
response, simply click on the response headline and copy the URL from the
browser window. A proportion of responses will, after editing, be published
online and in the print journal as letters, which are indexed in PubMed.
Rapid responses are not indexed in PubMed and they are not journal articles.
The BMJ reserves the right to remove responses which are being
wilfully misrepresented as published articles or when it is brought to our
attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not
including references and author details. We will no longer post responses
that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
The 52nd General Assembly of the WMA, in October 2000, approved
unanimously the fifth revision of the Helsinki Declaration, explicitly
denying the thesis that, in countries without access to the best treatment
available, it is justifiable to use a placebo. The outvoted revisionist
position pleaded for ethical permission , for example, to use a placebo
group instead of zidovudine, the effective drug, in studies on the
vertical transmission of AIDS in African countries.
It is frightening, however, that this thesis continues to be
defended, in a demonstration of disrespect for human beings who do not
have the possibility of access to effective drugs (1,2). Even more
worrying is that the WMA Council, taking advantage of there not being a
General Assembly in 2001, published a Note which, with the pretext of
clearing up doubts about the use of the placebo, included a substantial
modification of paragraph 29 of the Declaration, so recently approved by
the medical associations of the world. This Note affirms, for example,
that " a placebo-controlled trial may be ethically acceptable, even if
proven therapy is available ... where for compelling and scientifcally
sound methodological reasons its use is necessary to determinate the the
efficacy or safety of a prophylactic, diagnostic or therapeutic method ".
Now this assertion collides head on with the statement of paragraph 29 and
is dangerously vague, permitting interpretations which could result in
evident ethical infractions, where the billion dollar interests of the
pharmaceutical industry manage to prevail, that is, in developing
countries.
Even without the blessing of the Helsinki Declaration, an increasing
internationalization of research is taking place in human subjects, backed
by the pharmaceutical industry. Apart from being less costly in poor
countries, it is also possible to obtain consent for practices not
permitted in developed countries, especially those with anglo-american
traditions. Thus, for example, a protocol including a placebo group, even
with a effective treatment existing, is approved in the United States, but
carried out in centres in Latin America and not the country of origin.
The necessity for a placebo group, or no treatment, is frequently
identified as being necessary for scientific efficiency and to permit
medical progress and, consequently, benefit humanity. In fact, these are
the same arguments used to justify the many human research atrocities
performed during recent decades, since the Nazi medical investigations.
It is clear that the interests of science and society cannot be
invoked to the detriment of the well-being of human research subjects. The
relationship between the medical researcher and the patient, as a research
subject must be guided by the same ethical principles which govern the
relationship doctor-patient. Certainly there can be no observation
whatsoever of the principles of benificence and distributive justice when,
in poor countries, the effective treatment is substituted by a placebo.
Doctors must be attent to the fact that the financial attractions of
research supported by the pharmaceutical industry must not make them
abandon their professional ethics. Certainly all of us can and should
participate in drug research, whether or not supported by private
industry. But we must leave the executives of the supporting companies to
worry about market interests, competition and profits. Medical researchers
must look after the health and well-being of patients subjected to
research. This is the posture which will permit the equilibrium needed to
reach the healthy development of medical science.
The medical community must not accept the Note published by the WMA
Council, since only the General Assembly has the power to modify the
Helsinki Declaration. If the General Assembly agrees that the necessity
exists to admit the use of a placebo, even in those cases where effective
treatment exists, and where only a slight discomfort is caused to the
patients, then this modification must be very clearly stated so that there
can be no ample and dangerous interpretation.
The community must also be mobilized against the pharmaceutical
industry lobby, since, for a long time, the Helsinki Declaration ceased to
be simply a document for doctors, and became part of the patrimony of
mankind.
Roni Marques,Member of the Editorial Board of the Journal Bioetica,
retired professor of Medicine of the Universidade Federal do Rio de
Janeiro.
1. Bland JM. WMA should not retreat on use of placebos. BMJ 2002;
324:240
2. Bland JM. Fifth revision of Declaration of Helsinki. BMJ 2002; 324:975
3. Ferriman A. World Medical Association clarifies rules on placebo
controlled trials. BMJ 2001; 323:825
Competing interests:
No competing interests
02 May 2002
Roni Marques
Physician. Member of the Editorial Board of the Journal Bioética.
Rua Princesa Isabel, 282, Campo Grande, MS, Brazil, 79022450. dr.roni@terra.com.br
Medical community must not accept the Note of Clarification of the WMA Council
The 52nd General Assembly of the WMA, in October 2000, approved
unanimously the fifth revision of the Helsinki Declaration, explicitly
denying the thesis that, in countries without access to the best treatment
available, it is justifiable to use a placebo. The outvoted revisionist
position pleaded for ethical permission , for example, to use a placebo
group instead of zidovudine, the effective drug, in studies on the
vertical transmission of AIDS in African countries.
It is frightening, however, that this thesis continues to be
defended, in a demonstration of disrespect for human beings who do not
have the possibility of access to effective drugs (1,2). Even more
worrying is that the WMA Council, taking advantage of there not being a
General Assembly in 2001, published a Note which, with the pretext of
clearing up doubts about the use of the placebo, included a substantial
modification of paragraph 29 of the Declaration, so recently approved by
the medical associations of the world. This Note affirms, for example,
that " a placebo-controlled trial may be ethically acceptable, even if
proven therapy is available ... where for compelling and scientifcally
sound methodological reasons its use is necessary to determinate the the
efficacy or safety of a prophylactic, diagnostic or therapeutic method ".
Now this assertion collides head on with the statement of paragraph 29 and
is dangerously vague, permitting interpretations which could result in
evident ethical infractions, where the billion dollar interests of the
pharmaceutical industry manage to prevail, that is, in developing
countries.
Even without the blessing of the Helsinki Declaration, an increasing
internationalization of research is taking place in human subjects, backed
by the pharmaceutical industry. Apart from being less costly in poor
countries, it is also possible to obtain consent for practices not
permitted in developed countries, especially those with anglo-american
traditions. Thus, for example, a protocol including a placebo group, even
with a effective treatment existing, is approved in the United States, but
carried out in centres in Latin America and not the country of origin.
The necessity for a placebo group, or no treatment, is frequently
identified as being necessary for scientific efficiency and to permit
medical progress and, consequently, benefit humanity. In fact, these are
the same arguments used to justify the many human research atrocities
performed during recent decades, since the Nazi medical investigations.
It is clear that the interests of science and society cannot be
invoked to the detriment of the well-being of human research subjects. The
relationship between the medical researcher and the patient, as a research
subject must be guided by the same ethical principles which govern the
relationship doctor-patient. Certainly there can be no observation
whatsoever of the principles of benificence and distributive justice when,
in poor countries, the effective treatment is substituted by a placebo.
Doctors must be attent to the fact that the financial attractions of
research supported by the pharmaceutical industry must not make them
abandon their professional ethics. Certainly all of us can and should
participate in drug research, whether or not supported by private
industry. But we must leave the executives of the supporting companies to
worry about market interests, competition and profits. Medical researchers
must look after the health and well-being of patients subjected to
research. This is the posture which will permit the equilibrium needed to
reach the healthy development of medical science.
The medical community must not accept the Note published by the WMA
Council, since only the General Assembly has the power to modify the
Helsinki Declaration. If the General Assembly agrees that the necessity
exists to admit the use of a placebo, even in those cases where effective
treatment exists, and where only a slight discomfort is caused to the
patients, then this modification must be very clearly stated so that there
can be no ample and dangerous interpretation.
The community must also be mobilized against the pharmaceutical
industry lobby, since, for a long time, the Helsinki Declaration ceased to
be simply a document for doctors, and became part of the patrimony of
mankind.
Roni Marques,Member of the Editorial Board of the Journal Bioetica,
retired professor of Medicine of the Universidade Federal do Rio de
Janeiro.
1. Bland JM. WMA should not retreat on use of placebos. BMJ 2002;
324:240
2. Bland JM. Fifth revision of Declaration of Helsinki. BMJ 2002; 324:975
3. Ferriman A. World Medical Association clarifies rules on placebo
controlled trials. BMJ 2001; 323:825
Competing interests: No competing interests