Pregnancy, children, clinical trials and HIV infection. Ethical limitations and therapeutical implications.

Abstract

In what concerns women and children infected with HIV, clinical investigation related ethical issues are both unavoidable and controversial. Different arguments are presented by different partners, and policies and laws are made in order to protect women and children, who, in spite of all that, keep suffering the effects of all this controversy, protection and legislation. Evidence based Medicine is responsible for new and demanding challenges and the same ethics that requires that new drugs are used only after unquestionable safety and efficacy are presented, tends to protect children, pregnant women and other vulnerable groups from being exposed to investigational drugs. This is why there are so few therapeutical options for HIV-infected children and pregnant women. So, ironically, in times of evidence based medicine, these two special populations are treated in an empirical way, because the same Medicine that wants to protect them, offers wide-open doors to the most terrible infections that mankind has ever faced. In this article, ethical dilemmas, philosophical principles, epidemiological context and different perspectives concerning this painful, yet extremely important, subject will be presented. The purposes will be to broaden horizons, to stimulate discussion and to provide some light into a subject still so restrict, still so unspoken, still so left in the shadows of something that we like to describe as modern medicine.