The ethics of placebo-controlled studies on perinatal HIV transmission and its treatment in the developing world.

Perinatal HIV transmission in the United States has been greatly reduced since the 1993 discovery of zidovudine, known as protocol 076. However, a feasible treatment in developing countries has not yet been found due to the high cost and medical standards needed to implement protocol 076. This presents an ethical question: whether placebo or active control should be used in testing new treatments. Proponents of a placebo control argue that a placebo control is the only method that provides definitive evidence of efficacy and side-effects, especially important given the scarce financial resources present in developing countries. Critics, however, argue that the use of a placebo controlled study when an effective treatment exists would be jeopardizing the health of individuals in developing countries. The key to resolving this debate is realizing that protocol 076 would not necessarily be effective when transplanted to developing countries due to the lack of adequate medical infrastructure, malnutrition, prevalence of disease, and low standard of living--it is not certain protocol 076 would be better than placebo at all. Following this line of reasoning, quite a few placebo-controlled studies on perinatal HIV treatment have already been performed. Upon examination of this accumulated evidence, one finds that protocol 076, and shortened courses of it, are indeed effective in non-breastfeeding participants in developing countries; however, no treatment has been proven effective for breastfeeding populations. Therefore, it would be ethical to conduct placebo-controlled studies on breastfeeding populations, but not on non-breastfeeding populations.