FDA advisory panel voices concern over risks of HIV vaccine trials in teenagers

Jun 11 2008

An FDA advisory panel on Monday voiced concern over the potential risks of conducting early HIV vaccine trials among teenagers in the U.S., Bloomberg reports. According to the panel, although such trials are justified in countries where HIV/AIDS is spreading more quickly, the risks might not outweigh the benefits in the U.S.

The panel -- assembled by Robert Nelson, a pediatric ethicist for FDA -- is seeking methods to improve research guidelines for clinical trials in children, Bloomberg reports. The panel on Monday began examining the ethical and medical questions that would arise in developing vaccines and treatments for HIV/AIDS and other disorders, as well as finding medical uses for stem cells. According to Nelson, the meeting might lead to guideline documents for institutional review boards that oversee proposed research on humans.

Panelist Alan Fix, chief of NIH's Vaccine Clinical Research Branch, said that FDA had considered adding adolescents to a Merck vaccine trial in Africa prior to Merck's cancellation of its study in September 2007. "There was interest in seeing how" adolescents could be added to the trial, Fix said, adding, "Then the [initial study] results came out, so it became a non-issue."

Norman Fost -- a professor of pediatrics at the University of Wisconsin-Madison and chair of the panel -- said, "There was agreement that AIDS [vaccine] trials in adolescents should take place in countries where adolescents are at higher risk for AIDS, and that's in other countries." Eric Kodish, chair of the department of bioethics at the Cleveland Clinic, said, "In any disease, doctors who take care of adults have more scientific evidence to use than those taking care of children." He added that many scientists and companies are discouraged from conducting research among children because the group has limited legal standing and cannot make decisions for themselves. Although such protections are valuable, it means that the effects of drugs and other therapies on children is often inadequately understood (Lauerman, Bloomberg, 6/9).