The United Nations' AIDS program, UNAIDS, next week plans to hold a closed meeting in Geneva that will begin to sort out thorny new questions about the ethics of conducting HIV vaccine trials. A similar ethical dilemma is also broached in today's New England Journal of Medicine (NEJM): whether anti-HIV drugs considered to be the standard of care in the developed world should be offered to people in developing countries who take part in clinical trials.
Peter Lurie and Sidney Wolfe of the advocacy organization Public Citizen's Health Research Group focus on several trials around the world comparing a placebo to various regimens of the anti-HIV drug AZT to reduce transmission of HIV from an infected, pregnant mother to her child. The trials aim to test regimens that would be more affordable in poor countries. But Lurie and Wolfe--and NEJM editor Marcia Angell in an accompanying editorial--contend that because research has already proven that intensive treatment with AZT can reduce transmission by nearly 70%, these trials are unethical.
The issue is also critical to AIDS vaccine trials, because ethics require that people who become infected during a trial be offered the best available treatment. Yet if everyone in a vaccine trial who becomes infected is offered potent anti-HIV drugs, it makes it extremely difficult--if not impossible--to detect whether the vaccine can delay or prevent disease. Barry Bloom of the Albert Einstein College of Medicine in New York City, who heads the UNAIDS vaccine subcommittee, made this point at a congressional hearing last spring. Some researchers also argue that it is ethically acceptable to use placebos to test treatments in countries where the new HIV treatments are not available.
At the UNAIDS subcommittee meeting, set for 23 and 24 September, the panel will discuss "a framework to formulate these questions, and after a period of consultation try to come to some global consensus that protects everybody's rights," says Bloom. Public Citizen's Lurie maintains that there should only be one standard of care, but says, "agreeably, it's a difficult situation." Bloom hopes UNAIDS will hold an open meeting on the issue next spring.