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 different studies. The foster children ranged from infants to late teens, according to interviews and government records.
Several studies that enlisted foster children reported patients suffered side effects such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections.
In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage.
The government provided special protections for child wards in 1983. They required researchers and their oversight boards to appoint independent advocates for any foster child enrolled in a narrow class of studies that involved greater than minimal risk and lacked the promise of direct benefit. Some foster agencies required the protection regardless of risks and benefits.
Advocates must be independent of the foster care and research agencies, have some understanding of medical issues and “act in the best interests of the child” for the entirety of the research, the law states.
However, researchers and foster agencies told AP that foster children in AIDS drug trials often weren’t given such advocates even though research institutions many times promised to do so to gain access to the children.
Illinois officials believe none of their nearly 200 foster children in AIDS studies got independent monitors even though researchers signed a document guaranteeing “the appointment of an advocate for each individual ward participating in the respective medical research.”
New York City could find records showing 142 — less than a third — of the 465 foster children in AIDS drug trials got such monitors even though city policy required them. The city has asked an outside firm to investigate.
Likewise, research facilities including Chicago’s Children’s Memorial Hospital and Johns Hopkins University in Baltimore said they concluded they didn’t provide advocates for foster kids.
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.
Officials estimated that 5 percent to 10 percent of the 13,878 children enrolled in pediatric AIDS studies funded by NIH 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 caused by experimental treatments.
We can understand wanting the kids to get the best care but we don’t need what happened in Tuskegee to ever happen again.