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

infection that could have been prevented by AZT or a similarly effective regimen-a
total of 1,504 preventable deaths. Of these, 1,002 will occur in U.S.-funded studies
and 502 will occur in those funded by foreign govemrnments or the UnitedNations AIDS
program. Even if only the placebo arms of the studies are considered, a total of 714
preventable HIV infections, 435 of them in U.S.-funded studies, will occur.
It is a violation of basic research ethics to assert that the failure to prevent HIV
infection in these studies is somehow justified by the potential for preventing future
HIV infections based on data that may be generated in this research. As the World
Medical Association has declared: "Concern for the interests of the subject must
always prevail over the interests of science and society."23 In part, this ethical principle
was enunciated to prevent the more powerful from using theoretical future gains to
place the less powerful at risk in the present. Indeed, the very fact that the subjects of
these studies are persons of color from impoverished, mostly post-colonial societies
underscores the dangers of such rationalizations.
Clearly, any simpler or less expensive prophylactic regimen that was as
effective and safe as that used in Protocol 076 would be rapidly adopted in the
industrialized world and while it is true that many of the strategies being tested in
these studies are less expensive than that used in Protocol 076, they may still be
unaffordable in developing countries. There is, therefore, no guarantee that women
and infants in developing countries will even benefit from any knowledge gained from
this research. As a recent editorial entitled "Scientific Imperialism" in the British
Medical Journal proclaimed: "If they won't benefit from the findings, poor people in the
developing world shouldn't be used in research."24
Defenders of these studies will no doubt argue that the subjects are being
provided the "standard of care" practiced in these developing countries, which is to say
regimens that have not been proved effective or no treatment at all. (Of course, this
coerces potential subjects to enroll, as outside of the study they stand essentially no
chance of obtaining proven effective prophylaxis.) Yet the standard of care in the U.S.
-Protocol 076-can be delivered in the research setting in developing countries and is
essentially being provided as one of the arms of the only developing country study
here that is ethical: Harvard University's NIH-funded study of various regimens of AZT
prophylaxis in Thailand. Researchers acquire greater ethical responsibilities when they
enroll subjects in studies. As NIH Director Harold Varmus stated at a recent meeting
regarding the Alaska needle exchange study, clinical trials funded by the NIH should
comply with a higher ethical standard. Instead, many of these studies subscribe to a
kind of lowest corrnon denominator ethics in which the abominable state of health
23 World Medical Association, op. cit.
24 Vlmhurst P. Scientific imperialism. British Medical Joumal 1997;314:840-841.

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