Ethics and international research

doi:10.1136/bmj.316.7131.625a

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Placebo trials are unethical for established, untested treatments

E C O Edi-Osagie, Clinical research fellow, Department of Reproductive Medicine,
N E Edi-Osagie, Specialist registrar, Neonatal Medical Unit

St Mary's Hospital, Manchester M13 0JH
Public Citizen, 1600 20th Street, Washington, DC 20009-1001, USA
Centre Médical Evangelique, Nyankunde, Congo
Medical Practitioners and Dentists Board, Nairobi, Kenya
Clinical Pharmacology Section, Department of Medicine, University of Birmingham, Queen Elizabeth Hospital, Birmingham B15 2TH
Department of International Health, School of Hygiene and Public Health, Johns Hopkins University, 615 North Wolfe Street, Baltimore, MD 21205, USA
Department of Medicine, University Teaching Hospital, PO Box 50110, Lusaka, Zambia
Kara Counselling and Training Trust, Lusaka
Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London WC1E 7HT

EDITOR—In their editorial Halsey et al defended their placebo controlled trials of effective interventions to prevent maternal-fetal HIV transmission in developing countries.1 Their arguments in defence of these trials are weak. They cite the guidelines of the Council for International Organisations of Medical Sciences, which “call for universal principles of ethical research, not universal standards of medical care.” 1 2 This does not, however, justify their exposing pregnant women with HIV infection to placebo treatment in a trial that also offers appropriate treatment. Although prevailing economic circumstances in developing countries may preclude such women from routinely receiving effective treatment, this is no justification to deny the control arm in the trial of Halsey et al effective treatment because it would act as an undue incentive. We also do not agree with Lurie and Wolfe's counterarguments that studies supported by the American government should provide all participants with the same level of care that is available to Americans.3 Although this suggestion is ethically sound and desirable, it is highly impracticable.

We believe that any intervention in a research trial that deliberately sets out not to prevent an anticipated deleterious health condition (maternal-fetal HIV transmission in this case) is unethical and goes against the guidelines of the Council for International Organisations of Medical Sciences.2 Examples abound in contemporary medicine of established but untested interventions whose effectiveness cannot now be tested because subjecting people to placebo controlled trials of their effectiveness is considered to be unethical and unacceptable. Lurie and Wolfe's suggestion of comparing the new short course zidovudine regimens against the established ACTG 076 regimen is ethical and statistically sound. Perhaps more appropriate would be a three arm trial, with the new regimens and ACTG 076 making up two arms and the local population of pregnant women infected with …