critical puzzle. NIH will fund anti-HIV therapy trial at the South African clinic, but it will not pay for drugs.
AIDS researchers are angry about a draft policy on the National Institutes of Health (NIH) say they would make it more difficult to conduct trials in countries in development. AIDS main branch of the NIH's National Institute of Allergy and Infectious Diseases (NIAID), plans to researchers use external funds to pay for the drugs they want to test, and said to meet the standards of ethics researchers will ensure the treatment of trial participants after the study is completed.
proposed policy, a copy of which was obtained by science NOW, indicates that the cost of buying drugs for clinical trials "significantly limit the research capacity the Institute, by limiting the number, scope, duration and direction of international HIV-related research activities NIAID. "She adds that only" in exceptional circumstances "would NIAID foot the bill for the test drugs. The document goes on to say that it would be unethical to stop treatment when a trial ends. Researchers should therefore be required to submit a plan "to provide care and appropriate [antiretroviral] treatment for study participants after the trial." None of this is new, the paper notes: They simply formalize existing policies of NIAID. The issue comes to a head now because of the growing push to provide poor countries with effective combinations of HIV drugs that came on the market in rich countries and significantly slowed the disease.
A study by AIDS immunologist Luis Montaner, at the Wistar Institute in Philadelphia, crystallizes how politics can slow - if not derail - research. Montaner recently got a enthusiastic thumbs NIAID for a grant to finance a study of the drug in South Africa. But he can not use the money to buy drugs. And although convince a company to donate medicines for clinical trials required for regulatory approval is relatively easy, Montaner plans to test the schemes involving drugs already approved. Moreover, the study could lead to cheaper treatments that could reduce corporate profits. He argues that the NIAID should address drug costs as all other costs of research.
AIDS immunologist Bruce Walker of Massachusetts General Hospital in Boston called the NIAID draft policy "not very visionary," and he predicted it will "stifle progress." And it takes strong exception to the suggestion that researchers need to understand how to provide treatment after the end of a study. "We have many people who died are now alive because they are on therapy. People prefer to be alive and faced with having to understand what they will do in 3 years than being dead. "
related sites
site Montaner
AIDS NIAID website
0 Komentar