AIDS researchers are upset about a draft policy at the National Institutes of Health (NIH) that they say would make it more difficult to conduct trials in developing countries. NIH's main AIDS branch, the National Institute of Allergy and Infectious Diseases (NIAID), is considering making researchers use outside funds to pay for the drugs they want to test, and says to meet ethics standards researchers will have to guarantee the treatment of participants in the trial after the study is finished.
The draft policy, a copy of which has been obtained by ScienceNOW, states that the cost of purchasing drugs for clinical trials "would severely restrict the Institute's research capacity by limiting the number, scope, duration and focus of NIAID's international HIV-related research activities." It adds that only "under extraordinary circumstances" would NIAID foot the bill for test drugs. The document goes on to argue that it would be unethical to stop treatment when a trial ends. Researchers should therefore be required to submit a plan "to provide appropriate care and [antiretroviral] treatment for study participants after completion of the trial." None of these requirements is new, the document notes: They simply formalize NIAID's existing policies. The issue is coming to a head now because of the increasing push to provide poor countries with the potent combinations of anti-HIV drugs that have come to market in wealthy countries and dramatically slowed the disease.
A study led by AIDS immunologist Luis Montaner, at the Wistar Institute in Philadelphia, crystallizes how the policy can slow--if not derail--research. Montaner recently got an enthusiastic thumbs up from NIAID for a grant to fund a drug study in South Africa. But he cannot use any of the money to buy the drugs. And although convincing a company to donate drugs for clinical trials required for regulatory approval is relatively easy, Montaner is planning to test regimens involving already approved drugs. What's more, his study could result in cheaper treatments, which could cut into company profits. He argues that NIAID should address drug costs just like any other research costs.
AIDS immunologist Bruce Walker of Massachusetts General Hospital in Boston calls the NIAID draft policy "not very visionary," and he predicts that it will "stifle progress." And he takes strong exception to the suggestion that researchers must figure out how to provide treatment after a study ends. "We have plenty of people who were dying who are now alive because they're on therapy. People would rather be alive and faced with having to figure out what they're going to do in 3 years than be dead."