Washington – Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states, an Associated Press review has found.
The research, funded by the National Institutes of Health, spanned the country. It was most widespread in the 1990s as foster-care agencies sought treatments for their HIV-infected children that weren’t yet available in the marketplace.
The practice ensured that foster children – mostly poor or minority – received care from world-class researchers at government expense, slowing their rate of death and extending their lives. But it also exposed a vulnerable population to the risks of medical research and drugs that were known to have serious side effects in adults and for which the safety for children was unknown.
The research was conducted in at least seven states – Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas – and involved more than four dozen studies. The foster children ranged from infants to late teens, according to interviews and government records.
The government provided special protections for young wards in 1983. They required researchers and their oversight boards to appoint independent advocates for any foster child enrolled in studies that involved greater than minimal risk and lacked the promise of direct benefit.
However, researchers and foster agencies told The Associated Press that foster children in AIDS drug trials often weren’t given such advocates even though research institutions promised to do so to gain access to the children.
Several studies that enlisted foster children reported patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells. In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug.
Carol Salbenblatt, a nurse who recruits children for studies at Children’s Hospital in Denver, said there have been very few permanently placed foster children enrolled in studies. “I would say very few foster children have been enrolled and only under very stringent guidelines,” she said.
Children’s Hospital officials said only that the hospital has participated in about two dozen clinical trials studying HIV treatment and prevention since 1992.
Some states declined to participate in medical experiments.
Tennessee said its foster- care rules generally prohibit enlisting children in such trials. California requires a judge’s order. And Wisconsin “has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster-care system,” spokeswoman Stephanie Marquis said.
Liz McDonough, a spokeswoman for the Colorado Department of Human Services, said the state agency does not currently participate in any AIDS trials involving foster children.
“Foster parents do not have the authority” to permit foster children to take part in AIDS research, she said. “The county department (of social services) would have to seek and receive permission from the court” that has custody of the child.
Officials estimated that 5 percent to 10 percent of the 13,878 children enrolled in pediatric AIDS studies funded by the National Institutes of Health since the late 1980s were in foster care. More than two dozen Illinois foster children remain in studies today.
Some foster children died during studies, but state or city agencies said they could find no records that any deaths were directly attributed to the treatments.
Researchers typically secured permission to enroll foster children through city or state agencies. And they frequently exempted themselves from appointing advocates by concluding the research carried minimal risk and the child would directly benefit because the drugs had already been tried in adults.
Arthur Caplan, head of medical ethics at the University of Pennsylvania, said advocates should have been appointed for all foster children because 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.
“It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates,” Caplan said. “It is inexcusable that they wouldn’t have an advocate for each one of those children.”
Illinois officials directly credit the decision to enroll HIV-positive foster kids with bringing about a decline in deaths – from 40 between 1989 and 1995 to only 19 since.
The National Institutes of Health, the government health research agency that funded the studies, did not track researchers to determine whether they appointed advocates. Instead, the decision was left to medical review boards made up of volunteers at each study site.
The U.S. Office for Human Research Protections, created to protect research participants after the infamous Tuskegee, Ala., syphilis studies on black men, is investigating the use of foster children in AIDS research. The office declined to discuss the investigation.
Denver Post staff writer Karen Augé contributed to this report.
