Investigation Questions AIDS Drug Trials On NYC Foster Kids
A nearly 20-year investigation into the participation of New York City foster children in clinical drug trials for H.I.V. and AIDS has concluded that no children died as a result of the trials or that foster children were selected based on race.
New York’s child-welfare agency developed a policy in the late 1980s that let foster children participate in drug trials at a time when there were no approved treatments for children infected with H.I.V. and AIDS. Throughout the late 1980s to 2005, hundreds of children received medication during experimental trials.
However, many civil rights activists and City Council members expressed outrage after a freelance journalist claimed children were put in trials without their parents’ knowledge and given medications known to cause death.
In 2005, these claims were investigated by the Vera Institute of Justice, an independent nonprofit group. They determined that city officials had acted in good faith and in the interests of the children.
But it also discovered that the agency had not always followed its own protocols and kept poor records.
The Vera Institute eventually concluded that none of the 532 children in the trials died as a direct result of the medications, yet 25 children receiving treatment as part of the trials died during the trial years.
However, as some had alleged, foster children were removed from their families by the city because a parent had refused to consent to a child’s treatment.
The study found that researchers did not specifically select foster children for enrollment in the trials. And while the foster children were overwhelmingly black and Hispanic, as some critics emphasized, this was the typical profile of children with H.I.V. infection within the demographics of the city at the time.
Timothy A. Ross, the co-director of the project at Vera, said Children’s Services were aware that this was a very sensitive issue for a lot of important historic reasons.
“Children’s Services did research on the rules and regulations that applied, and developed a reasoned policy in the late 1980s,” he added. “The standard for enrolling kids in foster care that the child welfare agency used was higher than the federal standard.”
Ross also said that the institute noticed several problems suggesting there were clearly breakdowns in the implementation of that policy.
He said 64 children participated in 30 medication trials that were not reviewed by a special medical advisory panel, as per the city’s policy requirements. And 21 children participated in trials that the panel had reviewed but had not recommended. In both cases, 13 of the enrollments occurred before the children were placed in foster care.
Ross said even though medical regulations and the city’s own policies mandated that informed consent records be kept, the forms from biological parents or guardians were missing from the child-welfare files in 21 percent of cases.
“We found a disturbing lack of medical consent forms,” he said.
Ross told the New York Times that some cases were found to contain handwritten consents rather than the official consent forms””makeshift permissions that violated both city policy and federal regulations.
“In very general terms, it puts to rest the most egregious charges that were being made by a few people three or four years ago,” said John B. Mattingly, commissioner of the Administration for Children’s Services. “No children were yanked from their homes. That is all completely false.”
But Liam Scheff, the Boston-based journalist who first made the alarming charges about the trials, questioned that finding.
“Now they admit that the children died, but, oh, it couldn’t have been the drugs,” Scheff told the New York Times. “How do they know? How do they tell the difference?”
The drugs in question had FDA warnings on them and they had “caused permanent injury and painful death in adults who have taken the exact same drugs at normal prescribed doses.”
Scheff said children died, and countless others were made sick while taking these drugs, because of a diagnosis that is itself overly harsh and overly deterministic.
He added that the diagnoses were based on faulty H.I.V. testing technology.
“The agency had already taken steps to ensure that policies are properly enforced in any future clinical trials involving foster children,” Mattingly said. “Today, no children are involved in medication trials.”
The agency has since changed the way it catalogues and maintains archived case records. In 2004, an electronic system was established that allows for prompt retrieval of all case files.
An additional policy calls for more review by Family Court when a parent is not available to provide consent.
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