- Email: [email protected]
Undue inducement
Correspondence
Still Pictures
Rights were not granted to include this image in electronic media. Please refer to the printed journal
1356
Immunomodulatory treatments have so far shown little benefit in rheumatic fever, although we concurred in our Seminar that larger trials of immunoglobulins are needed in chorea. However, there are reasons to believe that these measures might not work, particularly since chorea is often a delayed manifestation of rheumatic fever, occurring when all other signs of active inflammation have subsided. Until further data are available, we believe that immunoglobulins and steroids are not indicated for chorea. Innocent Monya-Tambi and colleagues might have misinterpreted our comments about primary prevention. We agree that penicillin treatment of individual cases of group A streptococcal pharyngitis can prevent subsequent rheumatic fever, and that this strategy should be promoted to health staff and patients. The challenge is to translate this information into a practical, costeffective strategy on a populationwide basis. The model of sore throat treatment that Monya-Tambi and colleagues suggest should be shown to work and remain sustainable in practice before becoming the standard of care. The difficulties facing such a strategy include determining which sore throats are suspected to be streptococcal, providing clear messages to health workers, ensuring a supply of good-quality benzathine penicillin, encouraging people with sore throat to seek medical care, and understanding that in many populations most cases of rheumatic fever are not preceded by a sore throat. The increased efficacy of more frequent dosing of benzathine penicillin G must be balanced against the difficulties in maintaining high levels of adherence to these regimens. We see few recurrences of rheumatic fever in people who adhere to 4-weekly injections. For example, in New Zealand, the recurrence rate of rheumatic fever is low (0·6 recurrences per 100 patientyears) despite 4-weekly dosing being standard except if breakthrough rheumatic fever has occurred.5
The Cape Town experience reinforces the need for clinicians to understand the pattern of rheumatic fever in their own setting—preferably with the assistance of local research or surveillance— and to adapt recommendations, including ours, to their own circumstances. We declare that we have no conflict of interest.
*Jonathan R Carapetis, Malcolm McDonald, Nigel J Wilson [email protected] Royal Children’s Hospital, Flemington Road, Parkville, Victoria 3052, Australia (JRC); Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia (MM); and Department of Cardiology, Starship and Green Lane Hospitals, Auckland, New Zealand (NJW) 1
2 3
4 5
Carapetis JR, Currie BJ. Rheumatic chorea in northern Australia: a clinical and epidemiological study. Arch Dis Child 1999; 80: 353–58. Lessof MH, Bywaters EG. The duration of chorea. BMJ 1956; ??: 1520–23. Aron AM, Freeman JM, Carter S. The natural history of Sydenham’s chorea: review of the literature and long-term evaluation with emphasis on cardiac sequelae. Am J Med 1965; 38: 83–95. Shields WD, Bray PF. A danger of haloperidol therapy in children. J Pediatr 1976; 88: 301–03. Lennon D. Rheumatic fever: a preventable disease? The New Zealand experience. In: Martin D, Tagg J, eds. Streptococci and streptococcal diseases: entering the new millennium. Porirua: Institute of Environmental Science and Research (NZ), 2000: 503–12.
Undue inducement Ezekiel Emanuel and colleagues (July 23, p 336)1 present a scholarly examination of undue inducement to partake in research. What is surprising is that it appears in a medical journal and not a philosophy journal. We say this because its abstract approach applies to any activities involving inducements and does not in any way take into account any special responsibilities medical investigators might have toward subjects. Indeed, the article focuses entirely on the party being induced—the research subject—and says not a word about the roles and responsibilities of the inducer—the researcher. If an investigator offers US$100 for research subjects to undergo unnecessary lumbar punctures, poor people will
volunteer and rich people will not. According to Emanuel and colleagues, the poor people have not been “unduly induced”. Indeed, this may be technically correct, but it is irrelevant to the ultimate ethical question. The poor will be used to benefit the rich—a reality that runs throughout society. The hard question is whether medical and research ethics should continue to encourage this reality and exploit it, or whether we have some higher ethical obligations. The issue becomes even knottier when researchers go to poor countries to find their research subjects. Researchers need to ask themselves why they are using this population and what it is that they will leave behind. Often the researchers will take the knowledge they obtain home with them and the population who provided the information will receive nothing. Although this does not constitute undue inducement, it does constitute exploitation. Emanuel and colleagues take comfort in the argument that so long as the research is “otherwise ethical” there is no ethical problem in requiring people to become research participants in order for them to obtain the drugs that people in rich countries receive as a matter of course. They argue that “participants” will receive a benefit from being able to obtain drugs that would otherwise be unobtainable to them. Three separate issues arise from this argument. The first is that it confuses the practice of medicine with research. If we knew that the subjects would benefit, there would be no reason to do the research. Second, if we knew the population would benefit, we should use our resources to provide that population with the beneficial therapy, not do research on them. People should not have to become research subjects to receive medical care. And finally, when research is done in impoverished countries, we need to ask whether that is the only place the research can be done. If the research question can be answered using a more privileged population of www.thelancet.com Vol 366 October 15, 2005
Correspondence
In this letter we use the term “subject”. The Lancet prefers the term “participant” because it believes that “subject” implies that the person is subjected to the authority of the researcher. But while one is a subject, one is in fact required to follow the requirements of the research. Subjects do “participate”, but so do investigators, laboratory technicians, funders, and reviewers. We believe that the term “participant” euphemises away the real sacrifices subjects are asked to make. We declare that we have no conflict of interest.
supermarket are we not struck by the evacuee syndrome and fill our trolleys with products we do not really need? And yet we all become extremely rational beings when it comes to health care. The needs of patients still differ from the needs of the chief stakeholders. Suffice it to recall how a survey recently revealed that elderly women’s priorities did not coincide with the areas conventionally addressed by the health-care establishment. Results showed that older women were most interested in preventing memory loss, learning about the side-effects of medication, and correcting visual impairment.2 I declare that I have no conflict of interest.
Aldo Mariotto [email protected] Regione del Veneto, Azienda ULSS17, Via delle Palme 15, 35100 Padova, Italy 1 2
The Lancet. Will consumerism lead to better health? Lancet 2005; 366: 343. Tannenbaum C, Mayo N, Ducharme F. Older women’s health priorities and perceptions of care delivery: results of the WOW health survey. CMAJ 2005; 173: 153–59.
*Leonard Glantz, Michael Grodin [email protected] Department of Health Law, Bioethics and Human Rights, Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, USA 1
Emanuel EJ, Currie XE, Herman A, on behalf of Project Phidisa. Undue inducement in clinical research in developing countries: is it a worry? Lancet 2005; 366: 336–40.
Consumerism and health Your Editorial on consumerism in health care (July 30, p 343)1 states that, on the one hand, service provision must depend on the population’s needs and not on those of providers, and, on the other, that the medical profession must be recognised as being able to improve health. It is a fact that nowadays we all have a tendency towards consumerism. How many landline and mobile phones do we have in our homes? How many pairs of shoes do we own? How often do we change our car? When we go into a www.thelancet.com Vol 366 October 15, 2005
Gates’s grandest challenge We fully support the viewpoint of Anne-Emmanuelle Birn (Aug 6, p 514)1 that global health can only be improved with a combination of social and medical measures. Birn’s “alternative grand challenges” for the Gates Foundation should indeed be extended to all current efforts to improve global health, which seem on the contrary to be increasingly limited in their scope and objectives. For example, focusing on health interventions alone to reduce child mortality2 looks short-sighted and could reduce the chances of acting upstream on the factors that cause increased exposure and vulnerability of children to disease, and ultimately lead to death or to a miserable life. It is not a matter of being more ambitious, but of identifying the right strategy for the objective.
Between the early 1960s and the early 1980s, child mortality fell by 20% in Bangladesh but by 65% in Sri Lanka; by 10% in Uganda but by 50% in Kenya; and by 10% in Haiti but by nearly 80% in Costa Rica.3 Variations resulted from differences in factors such as income gains for the poor, schooling, food security, and water and sanitation. Downstream interventions such as immunisation, integrated management of childhood illness, and essential newborn care are effective and sustainable to the extent that they are based on accessible, equitable, and efficient health systems, and on a broader policy framework of investments in the very young. As part of the international health community, we should not place restrictions on the interpretation of the Millennium Development Goals (MDGs). The MDGs, for example, include improvements in child survival but also in nutritional status and access to water and basic education. The MDGs represent our effort to improve the access of the poorest to the basic opportunities, not only to ensure their survival. There is good evidence that the greatest progresses in health have been obtained by addressing the multidimensional aspects of poverty—mainly education, water and sanitation, nutrition, reproductive rights, and social protection— which are the intermediate causes of higher exposure and susceptibility to disease and disability.4 Particularly for the poorest in a society, how to deliver effective interventions is only part of the problem. In most instances, the crucial problem is demand—ie, how to make investment in health conceivable and convenient for individuals, households, and communities. Which brings us once again to the core issue of policies to improve education (particularly of women), food security, information, property, land transport, and insurance schemes. Thus, to most effectively address the health needs of less developed
Rights were not granted to include this image in electronic media. Please refer to the printed journal Still Pictures
patients, then impoverished ones should not be used. Emanuel and colleagues seem to recognise the existence of these additional ethical issues at the very end of their piece when they say that, in the absence of undue influence, “There might be other ethical transgressions, such as violations of the eight principles for ethical research.” It is unfortunate that this proviso is hidden at the very end of the piece. It should be emphasised that the exploitation of impoverished research populations is separate from the issue of undue inducement. One would not want researchers who exploit the poor to feel good about it because they take comfort in not unduly influencing them.
1357
Still Pictures
Rights were not granted to include this image in electronic media. Please refer to the printed journal
1356
Immunomodulatory treatments have so far shown little benefit in rheumatic fever, although we concurred in our Seminar that larger trials of immunoglobulins are needed in chorea. However, there are reasons to believe that these measures might not work, particularly since chorea is often a delayed manifestation of rheumatic fever, occurring when all other signs of active inflammation have subsided. Until further data are available, we believe that immunoglobulins and steroids are not indicated for chorea. Innocent Monya-Tambi and colleagues might have misinterpreted our comments about primary prevention. We agree that penicillin treatment of individual cases of group A streptococcal pharyngitis can prevent subsequent rheumatic fever, and that this strategy should be promoted to health staff and patients. The challenge is to translate this information into a practical, costeffective strategy on a populationwide basis. The model of sore throat treatment that Monya-Tambi and colleagues suggest should be shown to work and remain sustainable in practice before becoming the standard of care. The difficulties facing such a strategy include determining which sore throats are suspected to be streptococcal, providing clear messages to health workers, ensuring a supply of good-quality benzathine penicillin, encouraging people with sore throat to seek medical care, and understanding that in many populations most cases of rheumatic fever are not preceded by a sore throat. The increased efficacy of more frequent dosing of benzathine penicillin G must be balanced against the difficulties in maintaining high levels of adherence to these regimens. We see few recurrences of rheumatic fever in people who adhere to 4-weekly injections. For example, in New Zealand, the recurrence rate of rheumatic fever is low (0·6 recurrences per 100 patientyears) despite 4-weekly dosing being standard except if breakthrough rheumatic fever has occurred.5
The Cape Town experience reinforces the need for clinicians to understand the pattern of rheumatic fever in their own setting—preferably with the assistance of local research or surveillance— and to adapt recommendations, including ours, to their own circumstances. We declare that we have no conflict of interest.
*Jonathan R Carapetis, Malcolm McDonald, Nigel J Wilson [email protected] Royal Children’s Hospital, Flemington Road, Parkville, Victoria 3052, Australia (JRC); Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia (MM); and Department of Cardiology, Starship and Green Lane Hospitals, Auckland, New Zealand (NJW) 1
2 3
4 5
Carapetis JR, Currie BJ. Rheumatic chorea in northern Australia: a clinical and epidemiological study. Arch Dis Child 1999; 80: 353–58. Lessof MH, Bywaters EG. The duration of chorea. BMJ 1956; ??: 1520–23. Aron AM, Freeman JM, Carter S. The natural history of Sydenham’s chorea: review of the literature and long-term evaluation with emphasis on cardiac sequelae. Am J Med 1965; 38: 83–95. Shields WD, Bray PF. A danger of haloperidol therapy in children. J Pediatr 1976; 88: 301–03. Lennon D. Rheumatic fever: a preventable disease? The New Zealand experience. In: Martin D, Tagg J, eds. Streptococci and streptococcal diseases: entering the new millennium. Porirua: Institute of Environmental Science and Research (NZ), 2000: 503–12.
Undue inducement Ezekiel Emanuel and colleagues (July 23, p 336)1 present a scholarly examination of undue inducement to partake in research. What is surprising is that it appears in a medical journal and not a philosophy journal. We say this because its abstract approach applies to any activities involving inducements and does not in any way take into account any special responsibilities medical investigators might have toward subjects. Indeed, the article focuses entirely on the party being induced—the research subject—and says not a word about the roles and responsibilities of the inducer—the researcher. If an investigator offers US$100 for research subjects to undergo unnecessary lumbar punctures, poor people will
volunteer and rich people will not. According to Emanuel and colleagues, the poor people have not been “unduly induced”. Indeed, this may be technically correct, but it is irrelevant to the ultimate ethical question. The poor will be used to benefit the rich—a reality that runs throughout society. The hard question is whether medical and research ethics should continue to encourage this reality and exploit it, or whether we have some higher ethical obligations. The issue becomes even knottier when researchers go to poor countries to find their research subjects. Researchers need to ask themselves why they are using this population and what it is that they will leave behind. Often the researchers will take the knowledge they obtain home with them and the population who provided the information will receive nothing. Although this does not constitute undue inducement, it does constitute exploitation. Emanuel and colleagues take comfort in the argument that so long as the research is “otherwise ethical” there is no ethical problem in requiring people to become research participants in order for them to obtain the drugs that people in rich countries receive as a matter of course. They argue that “participants” will receive a benefit from being able to obtain drugs that would otherwise be unobtainable to them. Three separate issues arise from this argument. The first is that it confuses the practice of medicine with research. If we knew that the subjects would benefit, there would be no reason to do the research. Second, if we knew the population would benefit, we should use our resources to provide that population with the beneficial therapy, not do research on them. People should not have to become research subjects to receive medical care. And finally, when research is done in impoverished countries, we need to ask whether that is the only place the research can be done. If the research question can be answered using a more privileged population of www.thelancet.com Vol 366 October 15, 2005
Correspondence
In this letter we use the term “subject”. The Lancet prefers the term “participant” because it believes that “subject” implies that the person is subjected to the authority of the researcher. But while one is a subject, one is in fact required to follow the requirements of the research. Subjects do “participate”, but so do investigators, laboratory technicians, funders, and reviewers. We believe that the term “participant” euphemises away the real sacrifices subjects are asked to make. We declare that we have no conflict of interest.
supermarket are we not struck by the evacuee syndrome and fill our trolleys with products we do not really need? And yet we all become extremely rational beings when it comes to health care. The needs of patients still differ from the needs of the chief stakeholders. Suffice it to recall how a survey recently revealed that elderly women’s priorities did not coincide with the areas conventionally addressed by the health-care establishment. Results showed that older women were most interested in preventing memory loss, learning about the side-effects of medication, and correcting visual impairment.2 I declare that I have no conflict of interest.
Aldo Mariotto [email protected] Regione del Veneto, Azienda ULSS17, Via delle Palme 15, 35100 Padova, Italy 1 2
The Lancet. Will consumerism lead to better health? Lancet 2005; 366: 343. Tannenbaum C, Mayo N, Ducharme F. Older women’s health priorities and perceptions of care delivery: results of the WOW health survey. CMAJ 2005; 173: 153–59.
*Leonard Glantz, Michael Grodin [email protected] Department of Health Law, Bioethics and Human Rights, Boston University School of Public Health, 715 Albany Street, Boston, MA 02118, USA 1
Emanuel EJ, Currie XE, Herman A, on behalf of Project Phidisa. Undue inducement in clinical research in developing countries: is it a worry? Lancet 2005; 366: 336–40.
Consumerism and health Your Editorial on consumerism in health care (July 30, p 343)1 states that, on the one hand, service provision must depend on the population’s needs and not on those of providers, and, on the other, that the medical profession must be recognised as being able to improve health. It is a fact that nowadays we all have a tendency towards consumerism. How many landline and mobile phones do we have in our homes? How many pairs of shoes do we own? How often do we change our car? When we go into a www.thelancet.com Vol 366 October 15, 2005
Gates’s grandest challenge We fully support the viewpoint of Anne-Emmanuelle Birn (Aug 6, p 514)1 that global health can only be improved with a combination of social and medical measures. Birn’s “alternative grand challenges” for the Gates Foundation should indeed be extended to all current efforts to improve global health, which seem on the contrary to be increasingly limited in their scope and objectives. For example, focusing on health interventions alone to reduce child mortality2 looks short-sighted and could reduce the chances of acting upstream on the factors that cause increased exposure and vulnerability of children to disease, and ultimately lead to death or to a miserable life. It is not a matter of being more ambitious, but of identifying the right strategy for the objective.
Between the early 1960s and the early 1980s, child mortality fell by 20% in Bangladesh but by 65% in Sri Lanka; by 10% in Uganda but by 50% in Kenya; and by 10% in Haiti but by nearly 80% in Costa Rica.3 Variations resulted from differences in factors such as income gains for the poor, schooling, food security, and water and sanitation. Downstream interventions such as immunisation, integrated management of childhood illness, and essential newborn care are effective and sustainable to the extent that they are based on accessible, equitable, and efficient health systems, and on a broader policy framework of investments in the very young. As part of the international health community, we should not place restrictions on the interpretation of the Millennium Development Goals (MDGs). The MDGs, for example, include improvements in child survival but also in nutritional status and access to water and basic education. The MDGs represent our effort to improve the access of the poorest to the basic opportunities, not only to ensure their survival. There is good evidence that the greatest progresses in health have been obtained by addressing the multidimensional aspects of poverty—mainly education, water and sanitation, nutrition, reproductive rights, and social protection— which are the intermediate causes of higher exposure and susceptibility to disease and disability.4 Particularly for the poorest in a society, how to deliver effective interventions is only part of the problem. In most instances, the crucial problem is demand—ie, how to make investment in health conceivable and convenient for individuals, households, and communities. Which brings us once again to the core issue of policies to improve education (particularly of women), food security, information, property, land transport, and insurance schemes. Thus, to most effectively address the health needs of less developed
Rights were not granted to include this image in electronic media. Please refer to the printed journal Still Pictures
patients, then impoverished ones should not be used. Emanuel and colleagues seem to recognise the existence of these additional ethical issues at the very end of their piece when they say that, in the absence of undue influence, “There might be other ethical transgressions, such as violations of the eight principles for ethical research.” It is unfortunate that this proviso is hidden at the very end of the piece. It should be emphasised that the exploitation of impoverished research populations is separate from the issue of undue inducement. One would not want researchers who exploit the poor to feel good about it because they take comfort in not unduly influencing them.
1357