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ofjob, etc.? How can we prevent or solve those problems?

Ô How to prevent the misunderstanding that the candidate vaccine can prevent
the disease? The misunderstanding may lead the subjects to expose to more
risk behaviors.
ÔWill subjects who contracted HIV during the study receive antiretroviral drugs?
What is the standard of care for these subjects? What is the meaning of "the

best proven therapeutic treatmenf' stated in the Declaration of Helsinki to be
applied for subjects in the developing world?
Ô And there may be many more similar questions resulted from being a volunteer

in this study.

In addition to the debate on ethics of HIV vaccine trial, there was another hot
issue regarding studies of short course AZT regimen to prevent mother-to-child transmission
(PMTCT). The study was sponsored by leading research institutes, e.g., the US CDC and

the US NIH. The studies were conducted in some developing countries in Asia and Affica.
One of a study was conducted in Bangkok, Thailand. All the studies were randomized
controlled studies, compared short course AZT with the placebo arm. It was strongly

criticized that it is unethical to use the placebo arm since ACTG 076 study has proven that
AZT can reduce the transmission rate by 66.7%. Some critics even compared these studies
to an infamous Tuskegee study in the US many decades ago. The editor of New England
Journal of Medicine, who was once recognized as one of 50 influential people in the US by
the TIME magazine, also criticized these studies very strongly. The US department of

Health and Human Services decided to open up the hearing of this issue.

The US Department of Health and Human Services finally argued that these

studies are ethical because the developing countries can not afford the cost of ACTG 076
regimen to reduce mother-to-child transmission. There was a need to study to find a much
less expensive and safe regimen. There was no other standard regimen provided as a
national program in the countries at the time when the studies were conducted. All these
studies can be continued. The study in Bangkok finished first and revealed that the short

course regimen, which cost only one-tenth of 076 regimen, could reduce MTCT by 50%.
All others studies were stopped because it was considered that the placebo arm could not be
perrilitted after that. The regimen from tile Bangkok Study had been named "Bangkok