Kiss of life: President George W. Bush plants a peck on HIV-positive Princess Zulu, from Zambia. Under a proposed new policy, Zambia is one of only a few African nations that would qualify for US-funded AIDS trials.
Kevin Lamarque/Reuters
The US National Institutes of Health (NIH) is quietly formulating a policy that will limit therapeutic HIV/AIDS trials to those countries that provide follow-up treatment to study subjects once the trial has ended. Whether the policy will push developing nations to devise follow-up programs or cut off their access to NIH-funded trials remains to be seen.
Officials at the National Institute of Allergy and Infectious Diseases (NIAID), which disburses most of NIH's AIDS monies, declined to comment on the policy while it is still under review. But several agency-funded scientists report that NIAID has asked for reports on how follow-up therapy will be delivered to study subjects. The new policy addresses one of the most vexing ethical issues in research: how to study life-saving drugs in countries where the drugs are virtually unavailable.
Although NIAID has not formally announced the policy, director Anthony Fauci reported the change to NIH director Elias Zerhouni at a meeting in January. According to minutes of the institute directors' meeting, Fauci said the policy is being introduced "because of the exorbitant costs of treating people in HIV/AIDS clinical studies indefinitely after the study has terminated, as well as the ethical considerations in stopping therapy after it has been started." Other NIH institutes agreed with this policy.
Just how researchers will cope with the new policy is not yet clear, says Myron Cohen, chairman of the Anti-Retroviral Therapy Working Group for NIAID's HIV Prevention Trials Unit, a worldwide network of research centers. "The question is going to be, what kind of commitments do you have to get from a country? This is where we sit now," Cohen says. He says he and other researchers are working amicably with NIAID to work out the details.
Few developing nations can afford to routinely offer antiretroviral therapy. Despite a mounting worldwide campaign to expand access, most of the world's more than 40 million AIDS victims remain untreated.
Many experts argue it is unethical to temporarily restore the health of ailing research subjects, only to send them back to death's door when trials end. Others say the cost of lifetime follow-up care would preclude research into new treatment strategies, some tailored to the developing world.
To close down the trials would also be to deny countries benefits such as new clinics, training for local doctors and access—albeit limited—to treatment, says Charlie van der Horst, an AIDS researcher working in Malawi.
At this point, it would be impossible to come up with a post-treatment plan, van der Horst says. "How are we going to pay for it?" he asks. "The Global Fund [to Fight AIDS, Tuberculosis and Malaria] is drastically underfunded."
Others say the NIAID policy is sensible, and post-treatment requirements will force scientists and funding agencies to push for better access. "It's saying we're not going to treat people like guinea pigs," says Joia Mukherjee, medical director of the treatment and advocacy group Partners in Health.
Peter Mugyenyi, director of the Joint Clinical Research Centre in Kampala, Uganda, says his government should—and will—take responsibility for post-study treatment. In the meantime, he says, studies should incorporate capacity building into their design. "We consider it unethical to deny one a chance to participate in a study [that] would increase the chances of an otherwise doomed patient."
NIAID, which is expected to spend $1.3 billion on AIDS research this year, is already working with host countries to improve their ability to deliver care, says Mark Harrington of Treatment Action Group, an AIDS advocacy organization. Harrington says the policy will push countries—some awaiting money from Bush's $15 billion AIDS initiative (see sidebar) or from the Global Fund—to create treatment programs.
"It's moving but it's not moving so fast that there isn't time to get it right," Harrington says. While it would be "unacceptable" to shut down studies, he adds, the NIAID policy is "going to help countries get their act together."
