Testimony before the Subcommittee on Human Resources, Committee on Government Reform and Oversight, U.S. House of Representatives

ethical standards applied should be no less exacting than they would be in
the case of research carried out in [the sponsoring] country." Yet there are
already worrisome signs that this fundamental ethical precept will be
ignored.
In June 1994, research on two so-called gpl20 HIV preventive vaccines was
reviewed by the blue-ribbon AIDS Research Advisory Committee (ARAC)
of the NIH, and the data were found to be insufficient to support
government-funded efficacy trials in the U.S. As far as we know, no data
have since been generated that would alter that assessment; indeed reports of
a dozen breakthrough infections among subjects fully vaccinated with gpl20
have raised further doubts about these vaccines' efficacy. Since 1994, most
attention in the HIV vaccine field has now shifted to the so-called ALVACHIV vaccine. Yet San Francisco-based Vaxgen is planning, with logistical
and statistical help from the Centers for Disease Control and Prevention, to
conduct a Phase III trial of its gpl20 vaccine in Thailand, even though that
vaccine had been rejected for efficacy trials in this country. This seems
unethical and exploitative, particularly as there is no guarantee that Thai
citizens or those of other developing countries will have access to the
vaccine should it be proved effective. Is Vaxgen planning on disclosing to
Thai subjects that the vaccine was rejected by U.S. scientists for tests in our
country?
Finally, some subjects in vaccine trials will contract HIV infections, either
because they are randomized to the placebo group or because the vaccine is
not completely effective (or perhaps not effective at all). While such newly
infected individuals in industrialized country trials can be referred for care,
there is concern that, in the developing countries where HIV vaccine trials
are being considered, effective anti-HIV drugs will not be provided to those
who become infected during the trial. We believe that it is the researchers'
ethical responsibility to ensure that antiviral drugs are provided to all
individuals who develop HIV infection during the trial, particularly because
participation in such trials may lead some subjects to believe that they are
protected from HIV infection and may thus induce them to increase their
risk behavior.
We will now turn to the subject of research on needle exchange programs,
which again illustrates the need for particular vigilance when conducting
research on vulnerable populations.

Since 1991, there have been seven federally funded reviews of the
effectiveness of needle exchange programs in preventing the transmission of
HIV infection between injection drug users and from the drug users to their

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