2005-05-25-NIH-Funded AIDS Drug Trials Involving Foster Children

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2005-05-25-NIH-Funded AIDS Drug Trials Involving Foster Children

 

Researchers who conducted NIH-funded HIV/AIDS drug trials involving hundreds of HIV-positive foster children often did not appoint independent advocates for the children, despite policies requiring the assignments, according to a review of the studies conducted by the... Associated Press. The studies tested AIDS-related medication in hundreds of HIV-positive foster children, allowing the children to receive treatment from top researchers but also exposing them to the risks of research and potentially serious side effects of the trial drugs.
Although the federal government since 1993 has required that researchers and oversight boards appoint independent advocates for foster children enrolled in studies that involve a greater-than-minimal risk or that might not provide a direct benefit, many researchers exempted themselves from the requirement by concluding that the research would directly benefit the children and involve minimal risk (Kaiser Daily HIV/AIDS Report, 5/5). Several newspapers recently have published editorials and opinion pieces on the issue. Some of these are summarized below.
Editorial


Toledo Blade: Although some antiretroviral drugs received FDA approval as a result of the trials, the fact that "federally funded medical research was done on foster children without basic advocate protection is appalling," a Blade editorial says. "Exploitation by any other name is exploitation," the editorial says, concluding, "The hard truth is these children were expendable because they were already sick, had no one to defend their interests and were available. There is nothing redeemable about that kind of world-class AIDS research, and those responsible must be held to account" (Toledo Blade, 5/13).


Opinion Pieces


Mereline Davis, Lexington Herald-Leader: The trials were primarily conducted "on the most vulnerable segment of our society: sick children of color without parents," and they often had nobody to advocate for them, columnist Davis writes in a Herald-Leader opinion piece. "In a country that rightfully calls us to arms when one child goes missing, shouldn't we be concerned about such a large number of unprotected children being used as lab rats?" Davis asks, concluding, "Shame on us for not taking better care of our kids" (Davis, Lexington Herald-Leader, 5/22).


Mark Kline, Toledo Blade: The foster children were not "single[d] out" but were included with "all other children in the same situation in studies of potentially lifesaving therapies," Kline, a pediatric AIDS specialist and director of the Baylor International Pediatric AIDS Initiative, writes in a Blade opinion piece. After "increasingly potent" antiretroviral drugs were approved for use by HIV-positive adults in the mid-1990s, "[c]learly studies were needed to figure out which drugs at which dosages worked best for" children, according to Kline. "In this era when there are few youngsters in the United States born with HIV and when those who have the disease receive potent treatments, it is easy to forget the desperate times when nothing we did seemed to work and children with HIV were dying quickly," Kline says (Kline, Toledo Blade, 5/21).


Broadcast Coverage
Several NPR programs reported on the issue:


NPR's "All Things Considered": The segment reports on last week's House Committee on Ways and Means Human Resources Subcommittee hearing on the inclusion of foster children in clinical trials. The piece includes comments from Alan Fleischman, a medical ethicist and professor of pediatrics at the Albert Einstein College of Medicine of Yeshiva University in New York City who was involved in the studies; Roberta Harris, deputy secretary for the Wisconsin Department of Health and Family Services; Rep. Pete Stark (D-Calif.); and Donald Young, deputy assistant secretary for planning and evaluation at HHS (Cornish, "All Things Considered," NPR, 5/22). The complete segment is available online in RealPlayer.


NPR's "All Things Considered": The program on Sunday also included an interview with Marjorie Speers, executive director of the Association for the Accreditation of Human Research Protections Programs, about the safety protocol and ethical questions surrounding drug trials involving children (Ludden, "All Things Considered," NPR, 5/22). The complete segment is available online in RealPlayer.


NPR's "News & Notes with Ed Gordon": The program on Tuesday will include an interview with a medical researcher about the case (Gordon, "News & Notes with Ed Gordon," NPR, 5/24). The complete segment will be available online in RealPlayer at 1 p.m. ET.

 


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