Government tested AIDS drugs on foster kids

'The most vulnerable subjects imaginable'
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.

“Our position is that advocates weren’t needed,” said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York.

If they decline to appoint advocates under the federal law, researchers and their oversight boards must conclude that the experimental treatment affords the same or better risk-benefit possibilities than alternate treatments already in the marketplace. They also must abide by any additional protections required by state and local authorities.

Many of the studies that enrolled foster children occurred after 1990 when the government approved using the drug AZT — an effective AIDS treatment — for children.

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.

“When you have the most vulnerable subjects imaginable — kids without parents — you really do have to come in with someone independent, who doesn’t have a dog in this fight,” he said.

Better access to drugs?
Those who made the decisions say the research gave foster kids access to drugs they otherwise couldn’t get. And they say they protected the children’s interest by carefully explaining risks and benefits to state guardians, foster parents and the children themselves.

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“I understand the ethical dilemma surrounding the introduction of foster children into trials,” said Dr. Mark Kline, a pediatric AIDS expert at Baylor College of Medicine. He enrolled some Texas foster kids in his studies, and doesn’t recall appointing advocates for them.

“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,” he said. “From an ethical perspective, I never thought that was a stand I could take.”

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.

NIH, the government health research agency that funded the studies, did not track researchers to determine if they appointed advocates. Instead, the decision was left to medical review boards made up of volunteers at each study site.

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