- Email: [email protected]
One standard, not two
CORRESPONDENCE
COMMENTARY
CORRESPONDENCE e-mail submissions to [email protected]
One standard, not two Sir—It is difficult to follow the logic of your Sept 27 Editorial.1 You claim that in postponing a decision to amend paragraph 30 of the Declaration of Helsinki, the World Medical Association (WMA) “lost an opportunity to make real progress for patients in trials in resource-poor nations”. As it stands, paragraph 30 states unequivocally: “At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study”.2 One of us (RC) was an independent observer at the WMA Annual Assembly and noted that there were two main proposals to amend or add a note of clarification to paragraph 30 under discussion (only part of one of these proposals is reproduced verbatim in your associated News article3). Many invited speakers and delegates, particularly but not exclusively those from developing countries, opposed these proposed changes because they were seen as introducing the very kinds of “get-out clauses” that this Editorial so vociferously opposes. Rather than hastily make amendments to paragraph 30, the WMA adopted a sensible and measured approach in convening a new workgroup to further consider these issues.4 The proposed changes risked introducing the very weaknesses the Editorial opposes—ie, “two ethical standards after a trial ends—one for rich and one for poor countries”. In the meantime, “postponing a decision” leaves the unequivocal statement of principle in place, so the way in which the WMA are “shirking their responsibility” is unclear. Given that the WMA are not in a position to simply over-ride issues raised by their constituent national medical associations (even if some might consider those issues misguided) and quash debate in the absence of a consensus, it is not apparent what “opportunity” was lost and it seems inappropriate to criticise their decision in the name of “one standard, not two”. Finally we think that more than just “practicalities” stand in the way of a solution to the wording of paragraph 30. The Editorial states: “Should noncommercial sponsors of research
assume the same responsibilities as drug companies (actually, yes, in our view)?” The distinction between commercial and non-commercial is not the only issue germane to the ethical debate. There is an ethically relevant difference between research done with the primary intent to benefit the population in which research takes place, and research done where the primary markets are not the population in which research is done.5 RC’s post is supported by an educational grant from Johnson and Johnson Ltd.
*Robert Carlson, Kenneth Boyd, David Webb Clinical Pharmacology Unit/Medical Teaching Organisation, University of Edinburgh, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, UK (e-mail: [email protected]) 1 2
3
4
5
The Lancet. One standard, not two. Lancet 2003; 362: 1005. World Medical Association Declaration of Helsinki. http://www.wma.net/e/policy/ b3.htm (accessed Oct 10, 2003). Frankish H. WMA postpones decision to amend Declaration of Helsinki. Lancet 2003; 362: 963. WMA to continue discussion on Declaration of Helsinki. http://www.wma.net/e/press/ 2003_19.htm (accessed Oct 6, 2003). Nuffield Council on Bioethics (UK). The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics, 2002: 125.
addressing the often difficult questions at the planning stage of research. It recommended that researchers should endeavour, before the start of a trial, to secure post-trial access for effective interventions for all participants. The lack of such arrangements should be justified to research ethics committees, in the sponsoring country as well as in the country where the research takes place. It is difficult to formulate general guidance that will apply in all circumstances. However, if sponsors were required to fund the future provision of interventions, either to participants in the study or the wider community, many would cease to support the research. Sponsors from the public sector would simply be unable to bear the costs involved without curtailing other research. It is crucially important that opportunities to improve health care, and to undertake otherwise valuable research, should not be lost. Some flexibility in guidance could be required in order to realise these benefits. Sandy Thomas Nuffield Council on Bioethics, 28 Bedford Square, London WC1B 3JS, UK (e-mail: [email protected]) 1 2
Sir—In your Editorial of Sept 27,1 in which you discuss proposed amendments to the Declaration of Helsinki, you state that “sponsors of trials in developing countries, and researchers there, must fulfil their lifetime responsibilities to the participants they recruit there. This is a non-negotiable standard”. Although this statement is commendably aspirational in concept, to guarantee the provision of an effective intervention is unlikely to be possible in practice for all cases, especially those involving long-term treatment for chronic disease. In a report published last year,2 the Nuffield Council on Bioethics discussed the complex issues surrounding the provision of treatment once a trial is completed. The Council emphasised the importance of
THE LANCET • Vol 362 • November 22, 2003 • www.thelancet.com
The Lancet. One standard, not two. Lancet 2003; 362: 1005. Nuffield Council on Bioethics (UK). The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics, 2002.
Making national DNA databases safer Sir—You are quite correct in observing in your Sept 20 Editorial1 that the public has failed to appreciate the significance and potential power of a national DNA database (NDNAD). Although a NDNAD can be used to acquit innocent citizens wrongly convicted,2 as the proportion of the innocent population in the database rises, the existence of the NDNAD poses significant risks to civil liberty. Many of my relatives were holocaust survivors of Nazi Germany. They recount horrific tales of the authorities in Germany and Poland tracing,
1761
For personal use. Only reproduce with permission from The Lancet publishing Group.
COMMENTARY
CORRESPONDENCE e-mail submissions to [email protected]
One standard, not two Sir—It is difficult to follow the logic of your Sept 27 Editorial.1 You claim that in postponing a decision to amend paragraph 30 of the Declaration of Helsinki, the World Medical Association (WMA) “lost an opportunity to make real progress for patients in trials in resource-poor nations”. As it stands, paragraph 30 states unequivocally: “At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study”.2 One of us (RC) was an independent observer at the WMA Annual Assembly and noted that there were two main proposals to amend or add a note of clarification to paragraph 30 under discussion (only part of one of these proposals is reproduced verbatim in your associated News article3). Many invited speakers and delegates, particularly but not exclusively those from developing countries, opposed these proposed changes because they were seen as introducing the very kinds of “get-out clauses” that this Editorial so vociferously opposes. Rather than hastily make amendments to paragraph 30, the WMA adopted a sensible and measured approach in convening a new workgroup to further consider these issues.4 The proposed changes risked introducing the very weaknesses the Editorial opposes—ie, “two ethical standards after a trial ends—one for rich and one for poor countries”. In the meantime, “postponing a decision” leaves the unequivocal statement of principle in place, so the way in which the WMA are “shirking their responsibility” is unclear. Given that the WMA are not in a position to simply over-ride issues raised by their constituent national medical associations (even if some might consider those issues misguided) and quash debate in the absence of a consensus, it is not apparent what “opportunity” was lost and it seems inappropriate to criticise their decision in the name of “one standard, not two”. Finally we think that more than just “practicalities” stand in the way of a solution to the wording of paragraph 30. The Editorial states: “Should noncommercial sponsors of research
assume the same responsibilities as drug companies (actually, yes, in our view)?” The distinction between commercial and non-commercial is not the only issue germane to the ethical debate. There is an ethically relevant difference between research done with the primary intent to benefit the population in which research takes place, and research done where the primary markets are not the population in which research is done.5 RC’s post is supported by an educational grant from Johnson and Johnson Ltd.
*Robert Carlson, Kenneth Boyd, David Webb Clinical Pharmacology Unit/Medical Teaching Organisation, University of Edinburgh, Western General Hospital, Crewe Road, Edinburgh EH4 2XU, UK (e-mail: [email protected]) 1 2
3
4
5
The Lancet. One standard, not two. Lancet 2003; 362: 1005. World Medical Association Declaration of Helsinki. http://www.wma.net/e/policy/ b3.htm (accessed Oct 10, 2003). Frankish H. WMA postpones decision to amend Declaration of Helsinki. Lancet 2003; 362: 963. WMA to continue discussion on Declaration of Helsinki. http://www.wma.net/e/press/ 2003_19.htm (accessed Oct 6, 2003). Nuffield Council on Bioethics (UK). The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics, 2002: 125.
addressing the often difficult questions at the planning stage of research. It recommended that researchers should endeavour, before the start of a trial, to secure post-trial access for effective interventions for all participants. The lack of such arrangements should be justified to research ethics committees, in the sponsoring country as well as in the country where the research takes place. It is difficult to formulate general guidance that will apply in all circumstances. However, if sponsors were required to fund the future provision of interventions, either to participants in the study or the wider community, many would cease to support the research. Sponsors from the public sector would simply be unable to bear the costs involved without curtailing other research. It is crucially important that opportunities to improve health care, and to undertake otherwise valuable research, should not be lost. Some flexibility in guidance could be required in order to realise these benefits. Sandy Thomas Nuffield Council on Bioethics, 28 Bedford Square, London WC1B 3JS, UK (e-mail: [email protected]) 1 2
Sir—In your Editorial of Sept 27,1 in which you discuss proposed amendments to the Declaration of Helsinki, you state that “sponsors of trials in developing countries, and researchers there, must fulfil their lifetime responsibilities to the participants they recruit there. This is a non-negotiable standard”. Although this statement is commendably aspirational in concept, to guarantee the provision of an effective intervention is unlikely to be possible in practice for all cases, especially those involving long-term treatment for chronic disease. In a report published last year,2 the Nuffield Council on Bioethics discussed the complex issues surrounding the provision of treatment once a trial is completed. The Council emphasised the importance of
THE LANCET • Vol 362 • November 22, 2003 • www.thelancet.com
The Lancet. One standard, not two. Lancet 2003; 362: 1005. Nuffield Council on Bioethics (UK). The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics, 2002.
Making national DNA databases safer Sir—You are quite correct in observing in your Sept 20 Editorial1 that the public has failed to appreciate the significance and potential power of a national DNA database (NDNAD). Although a NDNAD can be used to acquit innocent citizens wrongly convicted,2 as the proportion of the innocent population in the database rises, the existence of the NDNAD poses significant risks to civil liberty. Many of my relatives were holocaust survivors of Nazi Germany. They recount horrific tales of the authorities in Germany and Poland tracing,
1761
For personal use. Only reproduce with permission from The Lancet publishing Group.