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Government-funded researchers tested anti-HIV 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.

Government-funded researchers tested anti-HIV 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 that patients suffered side effects such as rashes, vomiting, and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress HIV 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 the Associated Press that foster children in anti-HIV 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 antiretroviral 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 anti-HIV 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% to 10% 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.

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 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 anti-HIV treatment--for children. Many studies that enlisted foster children involved early Phase I and Phase II research--the riskiest--to determine side effects and safe dosages so children could begin taking adult "cocktails," the powerful drug combinations that suppress HIV but can cause bad reactions like rashes and organ damage. Some of those drugs were approved ultimately for children, such as AZT and Zerit. Other medicines were not.

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." (AP)