This editorial is one of three articles that started the current debate about appropriate standards of care in clinical trials (the other two were an article by Peter Lurie and Sydney Wolfe in the same edition of the New England Journal of Medicine (see below), and an editorial in The Lancet). Marcia Angell criticises the placebo-controlled trials that were conducted to test an intervention to reduce mother-to-child transmission of HIV.

The article refers to the importance of researchers being in equipoise (i.e. not knowingly giving some groups of participants inferior treatment) and of not subsuming the interests of individual participants for the greater good. The author lists justifications that were given by research sponsors for this work: that participants were not being denied treatment that they would otherwise receive and that a placebo-controlled trial was the fastest and most efficient way to obtain information of relevance to the areas where the research was being conducted.

Angell concludes that these justifications were reminiscent of those of the infamous Tuskegee study where participants in the United States were not informed that they were enrolled in research, and were denied effective treatment for syphilis when this became available. Concern is expressed that the HIV study appears to mark a retreat from ethical principles about research conducted in developing countries as set out in international guidance - for example, participants received a local standard of care rather than the ‘best’ current treatment as required in the Declaration of Helsinki - and the reasons for this are critically examined.

Go to key document