Ethical considerations of clinical trials to prevent vertical transmission of HIV in developing countries

The Public Citizen's Health Research Group recently called attention to ethical concerns with trials of AZT which are either planned or underway in developing countries. The trials are being conducted to determine the minimum dose of AZT needed to prevent the vertical transmission of HIV from infected mothers to their unborn children. To that end, women who have given their informed consent to enter the trials are randomized into various dosage and placebo arms of the trials. The problem with this standard trial format in this case is that AZT is already proven capable of blocking approximately two thirds of transmissions of HIV to the fetus. The Public Citizen's Health Research Group therefore argues that the trials violate the Helsinki Declaration in that every patient enrolled in a clinical trial should be assured of receiving the best available treatment. Since these study subjects cannot obtain HIV prophylaxis elsewhere, they may enter the trials out of desperation, thereby invalidating their ability to autonomously consent to study participation. The author considers the ideal of informed consent which equates autonomy with competence rather than with freedom, whether freedom equals choice, and freedom, autonomy, and trials in developing countries. AZT vertical transmission trials could be markedly improved by replacing the placebo arm with a contrasting dose cohort.