ABSTRACT
In September 1997 two articles 1 , 2 published in the New England Journal of Medicine incited intense controversy about the ethical justification of randomized clinical trials. 3 These articles criticized as unethical the placebo-controlled clinical trials of AZT 4 for the prevention of perinatal transmission of HIV infection 5 currently being carried out in several technologically developing countries. These trials were called unethical principally on the ground that they violated Article II.3 of the Declaration of Helsinki:
In any medical study, every patient—including those of a control group, if any—should be assured of the best proven diagnostic and therapeutic method. 6
