1000 Foreign Infants to Die Unnecessarily in US-Funded HIV Studies: Human Experiments are Tuskegee Part Two, Says Health Groups

care in developing countries is used to justify withholding life-saving interventions.
Incredibly, most of these studies have, to the best of our knowledge, passed
ethical review by committees both in the developing country and in the West, providing
further proof of the inadequacy of the current review system. We believe that the
CDC-funded studies have passed review at the CDC itself, but do not know whether
NIH's Office for Protection from Research Risks reviewed the NIH-funded studies.
(The University researchers would also have been required to seek the formal
approval of the Institutional Review Boards at their own institutions.) These events also
demonstrate that the approval of a developing country ethics committee, while
essential, is not sufficient to guarantee an ethical study. Developing country
committee members, most of whom are likely to be researchers, are Usually from
social classes higher than the study subjects and may not be able to adequately
reflect the subjects' interests. For developing country researchers, involvement in
international studies offers obvious benefits in prestige and, perhaps, in salary.
It is true that providing AZT according to Protocol 076 or other similar regimens
to all subjects could lower the number of new HIV infections to the point that it may be
more difficult to statistically demonstrate differences between the study groups.
Indeed, this is the crux of the researchers' conflict of interest: it is the potential for
large numbers of infections among women denied AZT that makes the developing
countries "preferable" as study sites to industrialized countries where AZT would have
to be provided to all HIV-positive pregnant women. The solution to this conflict of
interest is not to create a research double-standard; it is to spend the money for larger
studies, perhaps at multiple sites in the industrialized or developing worlds, with
appropriate informed consent. For example, one study arm could receive AZT and the
other AZT and the experimental prophylactic regimen. With the public scrutiny that will
accompany these studies, as well as the HIV vaccine studies that may follow,
researchers cannot afford to be unethical.
The failure to provide effective prophylaxis to all women in these research
studies can also not be explained by the cost of providing AZT in the research setting;
after all, both the U.S. studies offer anti-HIV drugs to all subjects and seven of the
studies outside the U.S. provide some form of AZT prophylaxis in some study
treatment arms. The wholesale cost of the Protocol 076 regimen has been estimated
at $614m and $895m per person. In the context of the hundreds of thousands, if not
25 Gorsky RD, Famham PG, Straus WL, et al. Preventing perinatal transmission of HIV -
costs and effectiveness of a recommended intervention. Public Health Reports
1996;111:335-341.
I Mauskopf JA, Paul JE, VAchman DS, White AD, Tilson HH. Economic impact of
treatment of HIV-positive pregnant women and their newboms with zidovudine: implications for
HIV screening. Joumal of the American Medical Association 1996;276:132-138.

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