NIH-Sponsored AIDS Drug Trials "Often" Did Not Appoint Advocates for Foster Child Participants, Associated Press Reports
May 5, 2005
-funded HIV/AIDS drug trials involving hundreds of HIV-positive foster children in at least seven states "often" did not appoint independent advocates for the children, according to a review of the studies conducted by the Associated Press, the AP/Long Island Newsday reports. The studies tested AIDS-related medication in hundreds of HIV-positive foster children, allowing the children to receive treatment from "world-class" researchers but also exposing them to the risks of research and potentially serious side effects of the trial drugs, according to the AP/Newsday (Solomon, AP/Long Island Newsday, 5/5). The research among foster children was "most widespread" in the 1990s and was conducted in at least seven states, including Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas, according to the AP/San Francisco Chronicle. More than 48 HIV/AIDS-related drug studies involved foster children, most of whom were poor or minority and ranged in age from infants to late teens, according to government records and interviews, the AP/Chronicle reports. In several of the studies, foster child participants reported side effects, including vomiting, rashes and rapid declines in their CD4+ T cell counts, according to the AP/Chronicle (Solomon, AP/San Francisco Chronicle, 5/4). Some children died during the studies, although state or city agencies could not find evidence that any of the children's deaths being caused by the experimental drugs, according to the AP/Newsday.
Recommendations for Advocates
Researchers Say Advocates Not Needed
An unnamed spokesperson for the Office for Human Research Protections said that the agency has a "single, open case investigation" against Columbia-Presbyterian Medical Center, according to the Houston Chronicle. However, the spokesperson added, "I can't speak to any other (institution) or what may happen in the future" (Hopper, Houston Chronicle, 5/4). Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania School of Medicine, said advocates should have been appointed for the children because the researchers "felt the pressure of a medical crisis and knew there was great uncertainty as to how children would react to AIDS medications that were often toxic for adults," according to the AP/Newsday. "It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates," Caplan said, adding, "It is inexcusable that they wouldn't have an advocate for each one of those children." Some of the researchers said that advocates were not required because the researchers "protected the children's interest by carefully explaining risks and benefits to state guardians, foster parents and the children themselves," the AP/Newsday reports. "I understand the ethical dilemma surrounding the introduction of foster children into trials," Mark Kline, a pediatric AIDS expert at Baylor College of Medicine, who does not recall appointing advocates for foster children enrolled in his studies, said. He added, "To say as a group that foster children should be excluded from clinical trials would have meant excluding these children from the best available therapies at the time. From an ethical perspective, I never thought that was a stand I could take" (AP/Long Island Newsday, 5/5).
Institute of Medicine Recommendations
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.