The resources available for health care vary enormously worldwide. Thus, the same condition may be treated in various ways in different countries, which often means that the outlook for those living in the poorest countries is substantially worse than for those with the same condition in wealthier countries. Many would judge these inequalities to be offensive to our ethical systems that hold all human lives to be of equal value, but nonetheless the profound injustice in the global distribution of health resources is ugly but real.
Angell1 argued that in randomised clinical trials, patients in the control group must receive the best known treatment. She maintains this view even if the costs of providing this treatment are far beyond the resources that would normally be available in the country in which the trial is conducted, as is the case in many developing countries for the intervention shown to reduce perinatal transmission of HIV-1 in the AIDS Clinical Trials Group (ACTG) 076 trial (conducted in the USA and France).2 Your Sept 27 editorial3 seems to endorse Angell's view. If her argument is accepted then the implications for medical research on the health problems of poor countries are profound. Many cheap interventions that have been shown to reduce mortality and morbidity in those countries could never have been properly evaluated. Without valid data on effectiveness, it is unlikely that measures such as oral rehydration therapy, vitamin A supplementation, and syndromic treatment of sexually transmitted diseases would have been widely adopted, with the consequent loss of very many lives.
If investigators in a developing country plan a controlled trial to evaluate treatment options that are affordable and feasible in that country, and the study is judged to be ethical by an appropriately constituted ethical committee in that country, does the same investigation become unethical if the investigators seek financial support from a country in which the usual treatment option for the condition under study is better (and much more expensive) than those under trial? Of course, there must be appropriate ethical review in both countries in such situations, and the task of those on the ethical committee in the richer country is especially challenging because they must take into account the differences in health-care resources between the two countries. If they were always to take the simplistic view put forth by Angell and supported by your editorial, then not only would much highly relevant research in developing countries not be conducted, but that which is conducted may be irrelevant to the needs of those countries.
1AngellM. The ethics of clinical research in the Third World. N Engl J Med1997; 337: 847-849. CrossRef | PubMed
2ConnorEM, SperlingRS, GelberR, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med1994; 331: 1173-1180. CrossRef | PubMed
a Epidemiological Research Unit, Copenhagen, Denmark; MRC HIV Clinical Trials Centre, University College London Medical School, London; Laboratorio de Epidemiologia, Centre de Pesquisa Rene Rachou, Belo Horizonte, Brazil; Epidemiological Research Unit, Hospital Clinic I Provincial, Barcelona, Spain; Brazilian Society of Infectious Diseases, Universidade Federal da Bahia, Salvador-Bahia, Brazil; Departmento de Medicina Social, Universidade Federal de Pelotas, Pelotas, Brazil; Navrongo Health Research Centre, Ministry of Health, Navrongo, Ghana; Uganda Virus Research Institute, Entebbe, Uganda; Institute de Biomedicina, Area Hospital Vargas, Caracas, Venezuela; MRC Laboratories, Banjul, The Gambia; Tuberculosis Research Centre, Indian Council for Medical Research, Madras, India; Centre for Research and Training in Skin Diseases and Leprosy, Tehran, Iran; London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK; Public Health Sciences Division, ICDDR.B, Dhaka, Bangladesh; UNDP/World Bank/WHO Special Programme for Research and Training on Tropical Diseases, WHO, Geneva, Switzerland; Christian Medical College Hospital, Vellore, India; Clinical Epidemiology Unit, University of The Philippines College of Medicine, Manila, Philippines; Johns Hopkins University, Department of International Health, Baltimore, MD, USA; Communicable Disease Surveillance Centre, Public Health Laboratory Service, London, UK; Department of Epidemiology and Public Health, Institute of Child Health, London, UK; Institute of Public Health, Makerere University Medical School, Kampala, Uganda; and Swiss Tropical Institute, Basel, Switzerland
London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK