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

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Buyers Up *Congress Watch * Critical Mass * Global Trade Watch * Health Research' Group ' Litigation Group
Joan Claybrook, President
April 22, 1997
Secretary Donna Shalala
Department of Health and Human Services
200 Independence Ave, SW
Washington, D.C. 20201
Dear Secretary Shalala:
Unless you act now, as many as 1,002 newbomrn infants in Africa, Asia and the
Caribbean will die from unnecessary HIV infections they will contract from their
HIV-infected mothers in nine unethical research experiments funded by your
Department through either the National Institutes of Health (NIH) or the Centers for
Disease Control and Prevention (CDC). Even though an NIH-funded randomized,
controlled trial (so-called Protocol 076) demonstrated in 1994 that the antiviral drug
AZT (zidovudine) can reduce transmission from mother-to-infant by approximately
two-thirds,' a finding so dramatic that the study was stopped prior to its scheduled
completion, some or all of the women in these nine developing country experiments
are still not being provided with effective prophylaxis, placing their infants at risk for
fatal HIV infection. Instead, they are offered either placebos or interventions that have
not been proved effective. In addition, 502 infants in six similar experiments funded by
foreign governments (France-two studies, Belgium, Denmark, South Africa) and the
United Nations AIDS program will contract HIV, making a total of 1,504 infants who
can be expected to die unnecessarily in these experiments, some of which are already
under way. These preventable deaths can be averted if you simply require all women
in these experiments to be offered some regimen of AZT, or any other regimen proved
sinilarly effective. We are not opposed to randorrized, controlled trials of different
kinds of arguably effective interventions to reduce mother-to-infant HIV transission
per Se; we do object to such trials if they deny women access to any intervention
already proved effective, such as AZT.,,,

1 Connor EM, Sperting RS, Gelber R, et al. Reduction of maternal-infant transmission of
human immunodeficiency, virus type 1 with zidovudine treatment. New England Joumrnal of
Medicine 1994;331:1173-1180., Ralph Nader, Founder
1600 20th Street NW " Washington, DC 20009-1001 * [phone]. pted or" ecvc'ec ac'~.