HIV Prevention Trials Ethical

We are writing to express our concern about a recent Public Citizen report that labeled as unethical most of the ongoing HIV prevention trials in various countries of the developing world, including a trial that we are implementing in Tanzania.

We are carrying out a trial to examine whether vitamin supplements reduce the risk of mother-to-child transmission of HIV-infection. In observational epidemiologic studies, vitamin A-deficient women were at increased risk of transmitting HIV infection to their babies compared with women who had sufficient levels of vitamin A. In a number of studies, poor status of vitamin A and other vitamins were associated with lowered immune function, possibly leading to a higher risk of transmission of the virus.

Our study was approved by the Ethical Clearance Committee of Muhimbili Medical Center in Tanzania, the Ethical Committee of the Tanzanian Ministry of Health and the Institutional Review Board of the Harvard School of Public Health. We regret the fact that the Public Citizen group feels that it is in a better position to decide what is ethical for HIV-infected women than these committees.

Our institutions have been involved in collaborative research and training in the public health field for the last 20 years, more recently focusing on issues related to HIV infection. Our primary concern has been to carry out well-designed and relevant studies, bearing in mind the interests of the primary beneficiaries, namely the participants in these studies and the larger communities from which they come. Misinformed advocacy by some colleagues in the scientific community and the media can be harmful to the same parties they had intended to assist. --Wafaie W. Fawzi, MD,   Assistant Professor, Harvard   School of Public Health,   --Gernard I. Msamanga, MD,   Chairman, Department of   Community Health Muhimbili   Medical Center