[Letter to Donna Shalala from Sidney M. Wolfe and Peter Lurie]

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the latter part of pregnancy and labor and delivery, but the infants were not to be given
AZT' in the third group. nu treatment (a placebo) was to be given to the mothers and
the infants. We have learned from four independent sources at Johns Hopkins that in
the past seveial weeks a decision was made by the Johns Hopkins researchers to drop
the third (placbbo.only) group and to conidu:t'the experiment as a comparison between
groups one and two to see if they are equivalent in reducing the rate of infections in the
infants.
This restructured (and now ethical) version of the Ethiopian study is similar to the
design in enother Nil 1-funded study which is ethical, tne study in ihailand involving Dr.
Marc Lallemant of Harvard University School of Public Health.' In that study, treatments
of differcnt prepartum (4 or 12 weeks) or post-partum duration (6 weeks or 3 days for
the infants) are being compared in a four-armed trial to determine whether their
effectiveness will be approximately equivalent. No women in that study get a placebo
and the Chair of the Harved School Of Public tealth's ethics review board refused to
allow the researchers to be swayed by NIH efforts to change the design to a placebocontrolled study. a design h e described as "unethical "
The logic of the Johns Hopkins researchers in abandoning the use of a placebo
for the 300 Ethiopi In women assigned to that group and providing some AZT treatment
for all wOrnen in the study must not be lost on the remaining NIH. or CDC-funded
studies. By eliminating the plautbo arm of the study, the Johns Hopkins researchers
are not only transforming their study ilto an ethical study, but are also acknowledging
that it is possible to conduct a scientifically valid and useful Study without the use of a
platebo arm, Because the availabi ty of AZT is probably as limited in Ethiopia as in any
other country in which these studies are planned or being conducted, the abandonment
of the placebo group in that country should be viewed as an ethical standard to which
all the remaining studies should adhere. Since these Johns Hopkins researchers have-,
to their credit- acknowledged the error of their ways. how can any of the other studies
involving placebos be allowed to continue as planrned?'
New Data from ACTG 076 ShowIng that Shorter Treatments Are Effective
ACTG 076 was stopped in late 1993 because it so clearly showed that AZT
significantly reduced HIV transmission to infants born to HIV-positive mothers that it
Lure P. Wlfe SM. Unctheql trials of intervcn nN t' rcduce pcrinatol 'anin s ion 01
Uhe tuman inmnodcticicncy virus in developing countrit. N ELg J Mcd 1997,337: 853.856.
2 Brcnnan TA. Les to (,ithert Mcier. Nilt,)ivision of R,'terswch Ethics. Decvmber 2S.
1994.