Physican, do no harm

Abstract

Recent publicity about unethical trials raises a number of questions about research in developing countries. It also reminds us of the limitations of accepted safeguards: some of the trials under attack passed ethical review boards in the funding countries and have the approval of the local governments.

Some months ago, the New England Journal of Medicine carried a comment on 15 ongoing clinical trials testing cheaper drug regimens to prevent maternal foetal transmission of HIV in Africa and Asia. Some 16,000 pregnant, HIV positive women were enrolled in the placebo-controlled trials. The problem: these trials began after AZT had been found to prevent such transmission by 50% or more, and is recommended to all HIV-positive pregnant women in western countries. In other words, thousands of women in the trials were getting sugar pills to test the efficacy of the new regimens.