April 5, 1999
Volume 51, No. 26
Researchers outline pediatric AIDS ethical guidelines
At the same time pediatric AIDS cases in the United States declined 43 percent between 1992 and 1996, the World Health Organization estimates that approximately 1,600 children worldwide are infected with HIV daily, equaling about 600,000 new infections annually, 90 percent of which occur in developing countries.
The decline in pediatric AIDS in the United States can be attributed to an improved standard of care that includes HIV counseling and testing for all pregnant women, a three-part regimen of zidovudine (ZDV) for HIV-infected pregnant women and careful obstetrical management.
A clinical trial in Thailand has demonstrated that, while not as effective as the three-part regimen, an alternative two-part regimen using a shorter course of ZDV is less expensive and easier to administer and can still have a dramatic effect on reducing perinatal HIV transmission.
The workshop participants concluded that effective and affordable interventions to prevent perinatal transmission in developing nations are an urgent necessity because these nations sustain the vast majority of all pediatric AIDS infections. All countries should be encouraged to review interventions that have been successful and make every effort to implement them, they said.
Even limited interventions that are simpler and more cost-effective can present problems in implementation, the participants pointed out. For example, although the two-part Thai regimen could provide an affordable, feasible intervention for some developing countries, it is still five to 20 times more than the total annual per capita health care expenditure in many developing nations.
Many pregnant women do not seek medical care until late in pregnancy or when labor begins, and many deliver their babies without trained health care professionals.
"Closing the gap between the practical requirements of the effective regimens for preventing perinatal HIV transmission and the medical and economic realities of developing nations will be necessary to control perinatal HIV infection worldwide," said Mark Feinberg, associate director of the Emory/ Atlanta Center for AIDS Research. This means that new, affordable and perhaps more effective interventions must be developed.
Sound scientific design as well as appropriate ethical standards must guide any interventions. The participants endorsed five ethical principals for research studies, which are intended to help avoid exploitation of vulnerable populations: the study problems should be a health priority established by public health officials in the host country and should be relevant to the study participants as well as to the host country; study participants should be assured the highest practically attainable standard of care in the host country; the study should not harm the health care resources or infrastructure of the locality; informed consent must be obtained from all study participants; and all parties involved should understand that if the intervention being studied should prove effective and safe, it will be considered for implementation in the host country. Furthermore, studies are only appropriate if there is a reasonable likelihood that the populations in which they are conducted stand to benefit from successful results.
Because of considerable differences among developing nations, ethical standards used in designing research trials should always reflect the economic, public health, medical and social realities of each host country, the participants said. Differences from country to country may exist in the definitions of what is the highest practically attainable standard of care.
Although each study participant in a particular country should be able to receive the highest standard of care for that country, there is no obligation to provide the participants with the highest standard of care attainable elsewhere in the world, the workshop group agreed.
In a host country where an effective antiretroviral regimen could be practically implemented, and where it could be expected to reduce HIV transmission, a study design should include at least one arm using one of these successful regimens, such as the three-part ZDV regimen or the two-part Thai ZDV regimen. However, in countries where there is currently no antiretroviral therapy available, and no reasonable expectation that it could be available in the near future, it would be necessary to test and identify a regimen that is more effective than no intervention at all but more affordable than the proven ZDV regimens.
Since breast-feeding in developing countries is responsible for many cases of mother-to-child HIV transmission, the workshop also addressed the medical and social consequences of alternatives to breast-feeding. The participants concluded that further studies should be conducted to define the health and social risks and benefits associated with breast-feeding alternatives.
Even though the workshop participants emphasized the global obligation to diminish the worldwide disparities in health care, they acknowledged that it is unrealistic to expect this problem to be resolved anytime soon. In the meantime, they concluded, it is critical for researchers to identify effective, practical interventions that can reduce perinatal HIV transmission.