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

In November 1996, the Protocol 076 researchers published updated data
describing their findings.13 In the placebo group, 22.6% of the infants of the HIVinfected mothers had become infected with HIV, compared to only 7.6% of those
treated with AZT, a reduction of approximately two-thirds. The provision of AZT to
HIV-positive pregnant women is still the only intervention for any group at risk for HIV
to be proved effective in reducing the number of new HIV infections in a randomized,
controlled trial. The impact on actual clinical outcomes in the U.S. has
been dramatic. Three recent reports document decreases in HIV transmission from
HIV-infected mother to infant of 50% or more.14',5's6
While the industrialized world celebrated these landmark findings, it quickly
became cldear that the vast majority of HIV-infected women would never receive this
potentially life-saving intervention due to both the exorbitant cost of the drug and
logistical difficulties in administering and assuring adherence with the complex
regimen.
VWe are, therefore, not opposed to research that modifies the regimen provided
in Protocol 076 in order to identify a simpler, less expensive, similarly effective or more
cost-effective intervention; we do object to studies in which, after the Protocol 076
results were available, some or all women are only given placebos or regimens
without support from randomized, placebo-controlled trials, and are not given effective
prophylaxis.
However, the researchers involved in these experiments have exploited the
inadequacies of the health care systems in developing countries to conduct research
they would never even consider in the U.S. VWe have obtained a table prepared in
13 Sperling RS, Shapiro DE, Coombs RW, et al. Maternal viral load, zidovudine treatment,
and the risk of transmission of human immunodeficiency virus type 1 from mother to infant.
New England Joumrnal of Medicine 1996;335:1621-1629.
14 Fiscus SA, Adimora AA, Schoenbach VJ, et al. Perinatal HIV infection and the effect of
zidovudine therapy on transmission in rural and urban counties. Joumrnal of the American
Medical Association 1996;275:1483-1488.
s15 Cooper E, Diaz C, Pitt J, et al. Impact of ACTG 076: use of zidovudine during
pregnancy and changes in the rate of HIV vertical transmission. In: Program and Abstracts of
the Third Conference on Retroviruses and Opportunistic Infections, Washington, D.C., January
28-February 1, 1996. Washington, D.C.: Infectious Diseases Society of America, 1996:57.
16 Simonds RJ, Nesheim J, Matheson P, et al. Declining mother to child HIV transmission
following perinatal ZDV recommendations. Presented at the 11th International Conference on
AIDS, Vancouver,Canada,July 7-12, 1996.

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