“From our perspective,   if no one answers the questions …  how could there be any protection on ethical abuses in clinical research for vulnerable women and children in resource poor countries?”

In September, 2009 we became aware that clinical research investigators had enrolled HIV-infected pregnant women and their infants in a study to compare the effect of two different treatments on the transmission of HIV.  The study provided what would be considered by some international HIV/AIDS organizations, inferior treatment. ref: “Optimal vs. Suboptimal Treatment” In doing so, the women and children in the inferior treatment group were placed at risk for HIV disease progression and premature death and their infants at increased risk for HIV infection. The justification for this research study was that the resource poor countries where the studies were being performed could not afford standard of care treatment and so evaluation of a less expensive but inferior treatment could be justified on economic grounds. This type of research however is not within the mission of the National Institutes of Health (NIH), the government organization supporting the research study, as clearly stated in their mission. “NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability.”

In essence NIH supported studies were being conducted to support the provision of inferior treatment to poor populations in resource poor countries. The studies were approved by internal review boards (IRBs) both in the US and in developing countries. Informed consents in the studies did not adequately inform the HIV pregnant women that they were not being given what was considered to be standard of care by other international organizations. see also: “An Open Letter”