Unethical trials of interventions to reduce perinatal transmission of HIV in developing countries
This 'sounding board' article in the New England Journal of Medicine is the most substantive of the three articles that stimulated international debate about the ethics of placebo-controlled trials in developing countries (the other two were editorials in the New England Journal of Medicine (see above) and The Lancet).
Lurie and Wolfe take the view that placebo-controlled trials of a less expensive course of antiretrovirals to prevent mother-to-child transmission of HIV were unethical and would lead to hundreds of preventable HIV infections in infants. They identify 18 placebo-controlled trials involving more than 17,000 women, of which two trials were conducted in the United States and the remainder in developing countries. All the participants in the US studies received some form of antiretroviral treatment. In contrast, some or all of the participants in 15 of the trials in developing countries (nine of which were funded by the US) were not provided with such treatment.
The authors list areas of agreement between the critics and supporters of such trials, and conclude that the sole point of disagreement is over what is the most appropriate standard of care to provide to the control group. They argue that given the current scientific evidence it would be possible to design shorter, more affordable antiretroviral treatment programmes without the need to conduct placebo-controlled trials.