- The Washington Times - Wednesday, May 4, 2005

ASSOCIATED PRESS

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 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.

Several studies that enlisted foster children reported that patients experienced side effects such as rashes and 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.

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 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.

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.

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.

Some foster children died during the studies, but state and 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 that the research carried minimal risk.

Arthur Caplan, head of medical ethics at the University of Pennsylvania, said advocates should have been appointed for all foster children.

“It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates,” Mr. Caplan said. “It is inexcusable that they wouldn’t have an advocate for each one of those children.”

Those who made the decisions say the research gave foster children access to drugs they otherwise couldn’t get.

“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 children 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.

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