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Gordon Nary

November 1997

When our association's efforts to jump-start a human safety trial of a live-attenuated HIV vaccine began to receive global media attention, there were appropriate concerns from some scientists about the potential risks of such a vaccine. We have responded to these concerns. But our responses, like the concerns themselves, are only opinions. Opinions can guide science, but they are not science. Until we have a human trial of a live-attenuated HIV vaccine, all we have is opinion.

A live-attenuated HIV vaccine will never be totally safe, which makes its potential use limited to the major epicenters or groups at greatest risk of infection for whom no other effective vaccine or treatment for HIV/AIDS is possible. Our goal should be to define the risk to volunteers and subsequently to the populations that would be candidates for the vaccine and to determine the ethically acceptable degree of risk compared to the lives in jeopardy.

The media have been obsessed with the speculative risk to the first few human safety trial volunteers that we are proposing be selected from our volunteer registry. But no one has been obsessed with the risk of HIV infection to the millions of men, women, and unborn children that will occur without the protection of an effective vaccine. This is not a speculative risk based on monkey data -- this is a real risk based on 8500 new cases of HIV infection every day.

Instead of defining the risk through human safety trials, we have found ourselves engaged in a debate over data, what data mean, and how much data is enough. But what are data? Incidence of infection is converted to data. Responses to vaccine are converted to data. Hundreds of monkeys are converted to data. Millions of human beings are converted to data. Unfortunately, the conversion of human beings to data, as necessary as it is for science, allows science to depersonalize our world. Data are only data. Data are not human life.

The question of when a human safety trial of a live-attenuated HIV vaccine is appropriate is not a question about data. It is a question about human beings -- the human beings who have volunteered for the human safety trial and the tens and possibly hundreds of millions of human beings who will die without an effective vaccine. While data may be the province of science, human beings are the province of bioethics.

Our association is seeking funding to convene a committee of international bioethicists to reexamine the ethical issues relative to vaccine development, the conduct of vaccine trials, and whether greater risks should be considered in the conduct of such trials when such risks to a few individuals can result in data necessary to bring a relatively safe and effective vaccine to market that can save millions of lives.

When CNN asked Mark Siegler, MD, director of the University of Chicago's MacLean Center for Clinical Medical Ethics, to join Charles Farthing, MD, in a discussion about our proposal for a human safety trial of a live-attenuated HIV vaccine, the news network demonstrated its insight into the real issues of this debate. We hope that more news organizations, more scientists, and more federal officials will follow CNN's lead in asking the advice of bioethicists.

©1997, Medical Publications Corporation

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