Wednesday, May 11, 2005

BALTIMORE — Foster children were entered into AIDS drug trials because it was the only way to get the latest drugs for children not responding to approved medications, a state official said yesterday.

The children under state care were enrolled in trials at Johns Hopkins and the University of Maryland Medical System, said Sue Fitzsimmons, a spokeswoman for the Department of Social Services.

“What we had was the medical community referring foster kids to the study because it was all that was available for them,” Miss Fitzsimmons said.

“It wasn’t like we had arranged with the places doing the protocols.”

Miss Fitzsimmons said records dealing specifically with foster children treated for AIDS were not kept and she did not know whether any of the children died while involved in the studies.

The U.S. Office for Human Research Protections is investigating the practice of using foster children in AIDS drug experiments.

Some foster children died during the studies, but officials with state and city agencies nationwide have said they have not found records showing any deaths were directly caused by the experimental treatments.

“There’s the feeling these kids were in the study because they were foster care kids, they were in the study because the only way they could get these medicines was to be in the study,” Miss Fitzsimmons said.

An Associated Press review found 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.

The research, conducted nationwide and funded by the National Institutes of Health, was most widespread in the 1990s as foster care agencies sought treatments that weren’t yet available in the marketplace for their HIV-infected children.

Maryland was one of at least seven states where the research was conducted on foster children ranging in age from infants to late teens, according to interviews and government records.

Side effects ranging from rashes, vomiting and sharp drops in infection-fighting blood cells were reported in several studies. In one study, researchers reported a “disturbing” higher death rate among children who took higher doses of one drug.

Many studies involved early Phase I and Phase II research — the riskiest — to determine side effects and safe dosages so children could begin taking powerful drug combinations that suppress AIDS but can cause side effects.

A Maryland case worker, who did not want to be identified because it could reveal the AIDS status of children who used to be under her care, said medications were approved for adults before children and the only way at times to get the drugs was to enroll the child in a drug study.

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