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

The scientific basis for treating HIV-infected pregnant women with AZT
It is projected that by the year 2000 six million pregnant women will be
infected with HIV, primarily in Asia and sub-Saharan Africa.8 In the absence of
prophylaxis, transmission from HIV-infected mother to infant occurs in between 13%
and 48% of pregnancies, with rates in developing countries typically being higher than
in industrialized countries.9 In the U.S., 933 AIDS cases involving mother-to-infant
transmission were reported in 1994, and, at least in the period prior to Protocol 076,
an estimated 1,000 to 2,000 HIV infections via this route were estimated to occur
annually.10
The single most important advance in the prevention of HIV transmission from
mother to infant has been the AZT regimen demonstrated to be effective in Protocol
076. Beginning in April 1991, researchers at a large number of sites in the U.S. and
France conducted a randomized, double-blind, placebo-controlled trial in which the
treatment group received oral AZT beginning at 14-34 weeks of pregnancy and
intravenous AZT during labor. The newboms received oral AZT beginning shortly after
birth and continuing for six weeks. In order to reduce the likelihood that subjects in one
of the two study arms were benefiting or being harmed compared to those in the other
study arm, a Data and Safety Monitoring Board was constituted and was scheduled to
review the interim results on three occasions. At the first interim analysis, in December
1993, the findings were so striking that the study was stopped and AZT prophylaxis
was offered to all women and infants still in the study." On June 6-7, 1994, the Public
Health Service convened a meeting to discuss the ramifications of Protocol 076 and
concluded that the full Protocol 076 regimen should be recommended to all
HIV-positive pregnant women without significant prior exposure to AZT, and should be
considered for other women on a case-by-case basis.12 Providing AZT thus became
the standard of care for HIV-infected pregnant women.
8 Scarlatti G. Paediatric HIV infection. Lancet 1996;348:863-868.
9 Dabis F, Mselatti P, Dunn D, et al. Estimating the rate of mother-to-child transmission
of HIV. Report of a workshop on methodological issues, Ghent (Belgium), 17-20 February,
1992. The Working Group on Mother-to-Child Transmission of HIV. AIDS 1993;7:1139-1148.
10 Centers for Disease Control and Prevention. National HIV serosurveillance summary:
results through 1992.Vol. 3 Atlanta: U.S. Department of Health and Human Services, Public
Health Service, 1994.
" Connor, EM, op. cit.
12 Centers for Disease Control and Prevention. Recommendations of the U.S. Public
Health Service Task Force on the use of zidovudine to reduce perinatal transmission of
human immunodeficiency virus. Morbidity and Mortality Weekly Report 1994;43(RR-11): 1-20.

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