- Email: [email protected]
The ethics industry
THE LANCET
common. If the ACTG 076 regimen were the control group, adverse outcomes observed in the trial could be attributed to zidovudine. Moreover, such trials must show the feasibility of oral zidovudine during labour, which has not yet been studied. The ethical issues in conducting research in developing countries are complex,5 but serious charges of research impropriety should not be made without considering the facts relevant to the research.
in early for antenatal care, give birth in hospital, do not breastfeed their babies, and do not have malaria, irondeficiency anaemia, or a host of other tropical diseases? The ACTG 076 protocol is a Procrustean solution for women in Africa, and it would be unfeasible and unethical to use it in a clinical trial design. Richard D Semba Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA 1
Kevin DeCock, Nathan Shaffer, Stefan Wiktor, *R J Simonds, Martha Rogers Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA 1 2
3
4
5
Editorial. The ethics industry. Lancet 1997; 350: 897. Simonds RJ, Rogers M. Preventing perinatal HIV infection: how far have we come? JAMA 1996; 275: 1514–15. WHO recommendations from the Meeting on Mother-to-Infant Transmission on HIV by Use of Antiretrovirals. Geneva: WHO, 1994. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997; 337: 853–56. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997; 337: 1003–05.
SIR—I was disappointed that in your Sept 27 editorial1 you accept the arguments of Lurie and Wolfe in the New England Journal of Medicine regarding the ethics of the clinical trials to reduce mother-to-child transmission of HIV-1 in developing countries. The conduct of these trials accords with the highest international ethical standards. I agree that the ethics industry should be rooted in clinical practice and not in armchair moral philosophy. Lurie and Wolfe have argued for equivalency studies in which new therapies are compared with the ACTG 076 protocol instead of placebo. The main problem with their argument is that the ACTG 076 protocol dictates that women must not breastfeed their babies, which is contrary to breastfeeding practice and policy throughout most of sub-Saharan Africa. There is no “best known therapy” or any therapy at all that has been shown for breastfeeding populations. Your allegation that “women in the placebo-treated group were harmed by receiving no effective treatment to prevent transmission of HIV to their children,” prompts the question, what would be that “effective treatment”? That African women behave like American women and come
Vol 350 • November 22, 1997
applicable to their circumstances and that a randomised controlled study was still warranted with placebo or routine treatment for the control group. Such studies are regularly published in most leading medical journals. Is The Lancet falling into the same trap that it accuses others of by applying different ethical and scientific principles to “impoverished Africans”?
Editorial. The ethics industry. Lancet 1997; 350: 897.
P A Cooper Department of Paediatrics, Johannesburg Hospital, Private Bag X39, Johannesburg 2000, South Africa 1
1
SIR—Your Sept 27 editorial fails to address the fact that in developing countries where drug trials are being conducted the “best possible intervention” is not usually available. Women attend antenatal clinics at a late stage of pregnancy or only at the time of delivery, so that antiviral medication cannot be started in the late second trimester. Similarly, intravenous drugs during labour may not be practical in many delivery settings and most women who are positive for HIV1 breastfeed after delivery. It is debatable whether even a modification of the original ACTG protocol 076 would be effective in these circumstances. In 1996, The Lancet published the results of a randomised trial on neonatal extracorporeal membrane oxygenation (ECMO)2 in the UK between 1993 and 1994, which showed a significantly better survival with ECMO than with conventional therapy. However, ECMO had been used in the USA since 1976 and three randomised studies had previously shown that ECMO improved survival. Until 1992, an ECMO registry in the USA recorded 7647 infants who received ECMO with impressive survival rates. It was felt at the time that a randomised trial would not be ethically acceptable in the USA. In the commentary accompanying the results of the UK study, R F Soll3 alluded to the ethical dilemma of conducting a randomised trial at that time with a control group who would receive routine therapy. By contrast, there is no suggestion in your editorial that this issue was considered a problem by The Lancet at that time. Was the control group not also “harmed” in the same way that you suggest occurred with respect to the HIV transmission studies? The ECMO study is just one example in which the researchers involved felt that, despite evidence in favour of an intervention, the evidence was not strong enough or necessarily
2
3
Editorial. The ethics industry. Lancet 1997; 350: 897. UK Collaboration ECMO Trial Group UK collaborative randomised trial of neonatal extra corporeal membrane oxygenation. Lancet 1996; 348: 75–82. Soll RF. Neonatal extracorporeal membrane oxygenation–a bridging technique. Lancet 1996; 348: 70–71.
SIR—You state the principle that doctors must do no harm, and go on to argue that “women in the placebotreated group were harmed by receiving no effective treatment to prevent transmission of HIV to their children”, in your Sept 27 editorial.1 My understanding is that in the absence of the study under consideration, those women would have received nothing. Given that as a point of departure, I find it difficult to comprehend how they are harmed by receiving the placebo. One further point concerns women not in the study: are they not also being harmed, by your logic, since they also receive nothing? William Vaughan 3 South Road, Chebeague island, ME 04017, USA Email: [email protected] 1
Editorial. The ethics industry. Lancet 1997; 350: 897.
The ethics industry SIR—I do not agree with the central conclusion of your Sept 27 editorial1 that medical ethics can be distilled into a few basic principles and a healthy respect for the law. Nor do I agree that medical ethicists are trying to act as moral experts for doctors. The daily work of doctors involves difficult ethical dilemmas for which they are not adequately prepared in their medical training. Although clinical experience is important in developing one’s ethical sense, this does not mean that medical ethicits have little to offer doctors. An example of this is the recent debate over euthanasia. Requests from patients for euthanasia are common occurrences for many
1547
THE LANCET
practising doctors, yet doctors’ responses to these requests vary widely. Some doctors are even prepared to break the law. It is unlikely that the legal framework will be able to resolve the individual moral dilemma presented to a practitioner who is contemplating euthanasia for a patient.2 Clearly, in some cases of euthanasia practitioners feel that they ought to help patients, but are not legally permitted to do so. Ethical principles—for example, “doctors should do no harm to patients” and “doctors should do their best for patients”—do not solve the dilemma. After consideration of such principles, it is no clearer how an individual practitioner should behave in response to a request for euthanasia. What constitutes harm to the patient and what constitutes benefit is unclear. Medical ethics allows doctors time to consider where they stand in response to the many ethical issues that confront them. Medical ethicists are highly skilled at clarifying arguments so that it is clear which principles lie at the bottom of the everyday decisions of doctors. Realising which principles lie at the bottom of my decisions has been one of the most important parts of my training. Peter M Bradley Public Health Medicine, Highfield, Northampton Health Authority, Northampton NN1 5DN, UK 1 2
Editorial. The ethics industry. Lancet 1997; 350: 897. Churchill LR, King NM. Physician assisted suicide, euthanasia, or withdrawal of treatment. BMJ 1997; 315: 137–38.
SIR—Medical ethicists, pursuing their rationalism and without empirical investigation, coerce physicians into making patient autonomy the basic tenet of their professional ethic. The displacement of doctor beneficience from that position has contributed substantially to the much weakening of the doctor-patient relationship, at least in the USA.2,3 Your Sept 27 editorial1 admirably states the heart of the matter: medical ethics needs constant re-examination, but changes should be empirically based, and not be the result of scholastic rationalism. Yours is the first prestigious publication to take notice of the present anomalous situation with regard to medical ethics, and one can hope that the mainstream of physicians will follow your lead. Henry A Shenkin The Quadrangle, Apt 3101, 3300 Darby Road, Haverford, PA 19041-1069, USA 1
Editorial. The ethics industry. Lancet 1997; 350: 897.
1548
2
3
Shenkin HA. Medical ethics: evolution, rights and the physician. Dordrecht: Kluwer Academic Publications, 1991: 491. Shenkin HA. Current dilemmas in medicalcare rationing: a pragmatic approach. Lanham: University Press of America, 1996: 109.
SIR—I would most strongly disagree that the ethics industry needs to be rooted in clinical practice. Arguably, ethics should lead medical practice. It is often only by questioning some of the established medical practices that fallacious or flawed reasoning becomes apparent. Medical ethicists involved in such inquiries are not, as your Sept 27 editorial1 suggests, indulging in “armchair moral philosophy”, but are fulfilling an important and necessary function. For example, Shaw,2 a practising physician, has argued that health care should be rationed by age. Intuition may tell us the same thing. The role of the medical ethicist is to ask whether (1) such intuitions are grounded in reasons, (2) whether it is morally acceptable to use age as a criterion to ration health care, and (3) if the justifications supporting rationing by age can be substantiated.3,4 Nobody would suggest that medical ethics can always give doctors answers to difficult questions any more than doctors always know which is the best treatment for their patient. But the good professional might at least ensure that the right questions are being asked and narrow down the available options. “Philosophy that wallows in theory and speculation” is bad philosophy. But well researched and well reasoned philosophical arguments are an essential aid to good medical practice. It is not good medical ethicists that are “quaintly redundant”, but the idea that ethics needs to be rooted in medical practice before it can be of value. Michael M Rivlin
fundamental principles. 2 Anyone with a rudimentary knowledge of the management of change would appreciate that recognition of key issues is essential for later influence of policy development. The solution to ethical dilemmas in medicine are not, as you suggest, clear-cut. Most doctors do not find it easy to identify the action that will achieve the apparently simple aim of doing the best for their patients. Indeed, some question whether such decisions should be made by doctors alone. As I have argued elsewhere, 3 the principle that doctors keep information about patients confidential is not an automatic solution to all the dilemmas we face in this area. Debate on ethical matters in everyday medicine too frequently goes no further than the doctor choosing the best treatment for patients. The concept of patient autonomy and the possibility that there may be different perceptions of what is best are not considered. To focus on the individual patient fails to take account of or answer the dilemmas of competing needs of individuals within health services. Moral philosophy enables us to question our automatic, knee-jerk reactions to problems, and helps us think differently, beyond the blinkered view provided by our medical culture. It is true that such skills only become valuable to clinical practice when applied to the specific problems encountered in this environment, but the skills themselves are generic. Sarah Hobson School of Epidemiology and Health Sciences, Medical School, University of Manchester, Manchester M13 9PT, UK 1 2
Department of Philosophy, University of Leeds, Leeds LS2 9JT, UK 3 1 2 3
4
Editorial. The ethics industry. Lancet 1997; 350: 897. Shaw AB. In defence of ageism. J Med Ethics 1994; 20: 188–91. Rivlin MM. Protecting elderly people: flaws in ageist arguments. BMJ 1995; 310: 1179–82. Rivlin MM. Can age based rationing of health care be morally justified? Mt Sinai J Med 1997; 64: 113–19.
S IR —You contend that the involvement of ethicists in debates on medical dilemmas is “quaintly redundant”. 1 The arguments used display a remarkable ignorance of what they can and have contributed. It is philosophers who have helped us to recognise the importance of
Editorial. The ethics industry. Lancet 1997; 350: 897. Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press, 1983. Warwick SJ. A vote for no confidence. J Med Ethics 1989; 15: 183–85.
SIR—Professional ethicists with no experience of clinical medicine have increasing influence over the work of clinicians. What need we of ethicists? What need indeed if, as you propose,1 most ethical dilemmas can be solved by simple appeal to fundamental principles—do no harm to patients, do your best for patients, keep information about patients confidential. If only this were true, we would face no dilemmas at all. All those disputes on abortion, euthanasia, resource allocation, notification of disease, and the rest would immediately dissolve and protagonists on either side would stand
Vol 350 • November 22, 1997
common. If the ACTG 076 regimen were the control group, adverse outcomes observed in the trial could be attributed to zidovudine. Moreover, such trials must show the feasibility of oral zidovudine during labour, which has not yet been studied. The ethical issues in conducting research in developing countries are complex,5 but serious charges of research impropriety should not be made without considering the facts relevant to the research.
in early for antenatal care, give birth in hospital, do not breastfeed their babies, and do not have malaria, irondeficiency anaemia, or a host of other tropical diseases? The ACTG 076 protocol is a Procrustean solution for women in Africa, and it would be unfeasible and unethical to use it in a clinical trial design. Richard D Semba Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA 1
Kevin DeCock, Nathan Shaffer, Stefan Wiktor, *R J Simonds, Martha Rogers Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA 1 2
3
4
5
Editorial. The ethics industry. Lancet 1997; 350: 897. Simonds RJ, Rogers M. Preventing perinatal HIV infection: how far have we come? JAMA 1996; 275: 1514–15. WHO recommendations from the Meeting on Mother-to-Infant Transmission on HIV by Use of Antiretrovirals. Geneva: WHO, 1994. Lurie P, Wolfe SM. Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 1997; 337: 853–56. Varmus H, Satcher D. Ethical complexities of conducting research in developing countries. N Engl J Med 1997; 337: 1003–05.
SIR—I was disappointed that in your Sept 27 editorial1 you accept the arguments of Lurie and Wolfe in the New England Journal of Medicine regarding the ethics of the clinical trials to reduce mother-to-child transmission of HIV-1 in developing countries. The conduct of these trials accords with the highest international ethical standards. I agree that the ethics industry should be rooted in clinical practice and not in armchair moral philosophy. Lurie and Wolfe have argued for equivalency studies in which new therapies are compared with the ACTG 076 protocol instead of placebo. The main problem with their argument is that the ACTG 076 protocol dictates that women must not breastfeed their babies, which is contrary to breastfeeding practice and policy throughout most of sub-Saharan Africa. There is no “best known therapy” or any therapy at all that has been shown for breastfeeding populations. Your allegation that “women in the placebo-treated group were harmed by receiving no effective treatment to prevent transmission of HIV to their children,” prompts the question, what would be that “effective treatment”? That African women behave like American women and come
Vol 350 • November 22, 1997
applicable to their circumstances and that a randomised controlled study was still warranted with placebo or routine treatment for the control group. Such studies are regularly published in most leading medical journals. Is The Lancet falling into the same trap that it accuses others of by applying different ethical and scientific principles to “impoverished Africans”?
Editorial. The ethics industry. Lancet 1997; 350: 897.
P A Cooper Department of Paediatrics, Johannesburg Hospital, Private Bag X39, Johannesburg 2000, South Africa 1
1
SIR—Your Sept 27 editorial fails to address the fact that in developing countries where drug trials are being conducted the “best possible intervention” is not usually available. Women attend antenatal clinics at a late stage of pregnancy or only at the time of delivery, so that antiviral medication cannot be started in the late second trimester. Similarly, intravenous drugs during labour may not be practical in many delivery settings and most women who are positive for HIV1 breastfeed after delivery. It is debatable whether even a modification of the original ACTG protocol 076 would be effective in these circumstances. In 1996, The Lancet published the results of a randomised trial on neonatal extracorporeal membrane oxygenation (ECMO)2 in the UK between 1993 and 1994, which showed a significantly better survival with ECMO than with conventional therapy. However, ECMO had been used in the USA since 1976 and three randomised studies had previously shown that ECMO improved survival. Until 1992, an ECMO registry in the USA recorded 7647 infants who received ECMO with impressive survival rates. It was felt at the time that a randomised trial would not be ethically acceptable in the USA. In the commentary accompanying the results of the UK study, R F Soll3 alluded to the ethical dilemma of conducting a randomised trial at that time with a control group who would receive routine therapy. By contrast, there is no suggestion in your editorial that this issue was considered a problem by The Lancet at that time. Was the control group not also “harmed” in the same way that you suggest occurred with respect to the HIV transmission studies? The ECMO study is just one example in which the researchers involved felt that, despite evidence in favour of an intervention, the evidence was not strong enough or necessarily
2
3
Editorial. The ethics industry. Lancet 1997; 350: 897. UK Collaboration ECMO Trial Group UK collaborative randomised trial of neonatal extra corporeal membrane oxygenation. Lancet 1996; 348: 75–82. Soll RF. Neonatal extracorporeal membrane oxygenation–a bridging technique. Lancet 1996; 348: 70–71.
SIR—You state the principle that doctors must do no harm, and go on to argue that “women in the placebotreated group were harmed by receiving no effective treatment to prevent transmission of HIV to their children”, in your Sept 27 editorial.1 My understanding is that in the absence of the study under consideration, those women would have received nothing. Given that as a point of departure, I find it difficult to comprehend how they are harmed by receiving the placebo. One further point concerns women not in the study: are they not also being harmed, by your logic, since they also receive nothing? William Vaughan 3 South Road, Chebeague island, ME 04017, USA Email: [email protected] 1
Editorial. The ethics industry. Lancet 1997; 350: 897.
The ethics industry SIR—I do not agree with the central conclusion of your Sept 27 editorial1 that medical ethics can be distilled into a few basic principles and a healthy respect for the law. Nor do I agree that medical ethicists are trying to act as moral experts for doctors. The daily work of doctors involves difficult ethical dilemmas for which they are not adequately prepared in their medical training. Although clinical experience is important in developing one’s ethical sense, this does not mean that medical ethicits have little to offer doctors. An example of this is the recent debate over euthanasia. Requests from patients for euthanasia are common occurrences for many
1547
THE LANCET
practising doctors, yet doctors’ responses to these requests vary widely. Some doctors are even prepared to break the law. It is unlikely that the legal framework will be able to resolve the individual moral dilemma presented to a practitioner who is contemplating euthanasia for a patient.2 Clearly, in some cases of euthanasia practitioners feel that they ought to help patients, but are not legally permitted to do so. Ethical principles—for example, “doctors should do no harm to patients” and “doctors should do their best for patients”—do not solve the dilemma. After consideration of such principles, it is no clearer how an individual practitioner should behave in response to a request for euthanasia. What constitutes harm to the patient and what constitutes benefit is unclear. Medical ethics allows doctors time to consider where they stand in response to the many ethical issues that confront them. Medical ethicists are highly skilled at clarifying arguments so that it is clear which principles lie at the bottom of the everyday decisions of doctors. Realising which principles lie at the bottom of my decisions has been one of the most important parts of my training. Peter M Bradley Public Health Medicine, Highfield, Northampton Health Authority, Northampton NN1 5DN, UK 1 2
Editorial. The ethics industry. Lancet 1997; 350: 897. Churchill LR, King NM. Physician assisted suicide, euthanasia, or withdrawal of treatment. BMJ 1997; 315: 137–38.
SIR—Medical ethicists, pursuing their rationalism and without empirical investigation, coerce physicians into making patient autonomy the basic tenet of their professional ethic. The displacement of doctor beneficience from that position has contributed substantially to the much weakening of the doctor-patient relationship, at least in the USA.2,3 Your Sept 27 editorial1 admirably states the heart of the matter: medical ethics needs constant re-examination, but changes should be empirically based, and not be the result of scholastic rationalism. Yours is the first prestigious publication to take notice of the present anomalous situation with regard to medical ethics, and one can hope that the mainstream of physicians will follow your lead. Henry A Shenkin The Quadrangle, Apt 3101, 3300 Darby Road, Haverford, PA 19041-1069, USA 1
Editorial. The ethics industry. Lancet 1997; 350: 897.
1548
2
3
Shenkin HA. Medical ethics: evolution, rights and the physician. Dordrecht: Kluwer Academic Publications, 1991: 491. Shenkin HA. Current dilemmas in medicalcare rationing: a pragmatic approach. Lanham: University Press of America, 1996: 109.
SIR—I would most strongly disagree that the ethics industry needs to be rooted in clinical practice. Arguably, ethics should lead medical practice. It is often only by questioning some of the established medical practices that fallacious or flawed reasoning becomes apparent. Medical ethicists involved in such inquiries are not, as your Sept 27 editorial1 suggests, indulging in “armchair moral philosophy”, but are fulfilling an important and necessary function. For example, Shaw,2 a practising physician, has argued that health care should be rationed by age. Intuition may tell us the same thing. The role of the medical ethicist is to ask whether (1) such intuitions are grounded in reasons, (2) whether it is morally acceptable to use age as a criterion to ration health care, and (3) if the justifications supporting rationing by age can be substantiated.3,4 Nobody would suggest that medical ethics can always give doctors answers to difficult questions any more than doctors always know which is the best treatment for their patient. But the good professional might at least ensure that the right questions are being asked and narrow down the available options. “Philosophy that wallows in theory and speculation” is bad philosophy. But well researched and well reasoned philosophical arguments are an essential aid to good medical practice. It is not good medical ethicists that are “quaintly redundant”, but the idea that ethics needs to be rooted in medical practice before it can be of value. Michael M Rivlin
fundamental principles. 2 Anyone with a rudimentary knowledge of the management of change would appreciate that recognition of key issues is essential for later influence of policy development. The solution to ethical dilemmas in medicine are not, as you suggest, clear-cut. Most doctors do not find it easy to identify the action that will achieve the apparently simple aim of doing the best for their patients. Indeed, some question whether such decisions should be made by doctors alone. As I have argued elsewhere, 3 the principle that doctors keep information about patients confidential is not an automatic solution to all the dilemmas we face in this area. Debate on ethical matters in everyday medicine too frequently goes no further than the doctor choosing the best treatment for patients. The concept of patient autonomy and the possibility that there may be different perceptions of what is best are not considered. To focus on the individual patient fails to take account of or answer the dilemmas of competing needs of individuals within health services. Moral philosophy enables us to question our automatic, knee-jerk reactions to problems, and helps us think differently, beyond the blinkered view provided by our medical culture. It is true that such skills only become valuable to clinical practice when applied to the specific problems encountered in this environment, but the skills themselves are generic. Sarah Hobson School of Epidemiology and Health Sciences, Medical School, University of Manchester, Manchester M13 9PT, UK 1 2
Department of Philosophy, University of Leeds, Leeds LS2 9JT, UK 3 1 2 3
4
Editorial. The ethics industry. Lancet 1997; 350: 897. Shaw AB. In defence of ageism. J Med Ethics 1994; 20: 188–91. Rivlin MM. Protecting elderly people: flaws in ageist arguments. BMJ 1995; 310: 1179–82. Rivlin MM. Can age based rationing of health care be morally justified? Mt Sinai J Med 1997; 64: 113–19.
S IR —You contend that the involvement of ethicists in debates on medical dilemmas is “quaintly redundant”. 1 The arguments used display a remarkable ignorance of what they can and have contributed. It is philosophers who have helped us to recognise the importance of
Editorial. The ethics industry. Lancet 1997; 350: 897. Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press, 1983. Warwick SJ. A vote for no confidence. J Med Ethics 1989; 15: 183–85.
SIR—Professional ethicists with no experience of clinical medicine have increasing influence over the work of clinicians. What need we of ethicists? What need indeed if, as you propose,1 most ethical dilemmas can be solved by simple appeal to fundamental principles—do no harm to patients, do your best for patients, keep information about patients confidential. If only this were true, we would face no dilemmas at all. All those disputes on abortion, euthanasia, resource allocation, notification of disease, and the rest would immediately dissolve and protagonists on either side would stand
Vol 350 • November 22, 1997