Tuskegee Redux? FDA advisory panel says it is unethical to test AIDS vaccines on U.S. children but OK to experiment on African children
By John Lauerman
Bloomberg
June 9, 2008
Early testing of experimental AIDS vaccines in teenagers may be ethically justified in countries where the disease is spreading more quickly than in the U.S., scientific advisers said today.
The risks of such trials may not outweigh the benefits in the U.S., according to the panel advising the Food and Drug Administration.
The advisers to the FDA are seeking ways to improve research guidelines for clinical trials in children. The panelists began looking at ethical as well as medical questions that would arise in developing treatments for disorders such as asthma, finding medical uses for stem cells and creating potential AIDS vaccines.
``There was agreement that AIDS trials in adolescents should take place in countries where adolescents are at higher risk for AIDS and that's in other countries,'' including in Africa, said Norman Fost, a pediatrics professor at the University of Wisconsin in Madison. Fost is chairman of the panel meeting today and tomorrow in Gaithersburg, Maryland.
Children often don't respond to drugs the same way adults do, according to scientists. Congress passed legislation in 2002 granting drugmakers extended patents on medicines that have been tested in children and mandating that the FDA hire a pediatric ethicist to push for safe medical research in children.
Robert Nelson, who has held that position for the past 18 months, asked that the advisory panel's two-day session be held to discuss research that poses some risk to children while offering them the prospect of benefit.
Review Boards
The area hasn't been given adequate attention, and the meetings may lead to guidance documents for the institutional review boards, or IRB's, that oversee proposed research on humans, Nelson said.
``This morning's discussion started with the HIV case but moved into a discussion of principles that have more general applicability,'' he said in an interview at the meeting.
Experimental products such as AIDS vaccines can pose risks to study participants. Whitehouse Station, New Jersey-based Merck & Co. was forced to halt a study of an AIDS vaccine last year after 49 people who received it became infected with the virus that causes the disease, compared with just 33 people in a group that got placebo inoculations.
Researchers had considered adding adolescents to another study of the Merck vaccine in Africa, said Alan Fix, a panel member who is chief of the Vaccine Clinical Research Branch at the U.S. National Institutes of Health in Bethesda, Maryland. The issue was still under FDA consideration when the results from the Merck trial, called STEP, became public, and the African test was also halted, he said in a telephone interview.
