Just months after a Kenyan orphanage was accused of conducting unauthorized drug trials on HIV-positive orphans, similar charges have surfaced in the US. Federal agencies are investigating allegations of misconduct in AIDS drug trials using children in New York City foster care.

In December, a BBC report aired interviews with children claiming that when new treatments made them sick, they were force-fed the drugs. The report also showed foster parents who said their children were taken away when they stopped giving them the drugs.

The charges focus on the Incarnation Children's Center (ICC) in Manhattan. From the early 1990s through 2002, about 60 HIV-positive children at the center took part in dozens of national clinical trials run by researchers at Columbia University Medical Center and other area hospitals.

The ICC denies the allegations. “Of course some kids were reluctant, as kids are, to take their medicine,” says Gerald McKelvey, a spokesperson for the ICC. But children were never force-fed, McKelvey says.

Of course some kids were reluctant, as kids are, to take their medicine. , Gerald McKelvey, Incarnation Children's Center.

The trials were approved by the Pediatric AIDS Clinical Trials Group (PACTG), a self-governing network that sets standards for care of HIV-infected children and is supported by the US National Institutes of Health. Some trials were sponsored by drug companies, including Genentech, Bristol-Myers Squibb and GlaxoSmithKline.

The accusations were first published by Liam Scheff, a freelance journalist who does not believe that HIV causes AIDS. In his report, Scheff wrote, “If we don't know how HIV works, or if it makes anyone sick, then it's unethical to treat any HIV-positive person with potentially fatal pharmaceuticals.”

In rare cases, the city took children away from foster parents who refused to give them the drugs, says McKelvey. According to a written statement from Columbia University, the drugs' side effects were never serious enough to warrant discontinuing treatment.

Most researchers agree that pediatric drugs should be tested in children because children react to diseases and drugs differently than adults do. Under federal law, parents have the right to decide how to balance the promise of new treatments with any adverse affects, and can pull a child out of a trial at any time.

But for foster children, whose legal guardian is a city or state agency, informed consent is more complicated. In the early 1990s, New York City's Department of Health had the power to enroll these children in drug trials. That power now belongs to the city's Administration for Children's Services.

One patient advocacy group, the Alliance for Human Research Protection, says the city has violated federal regulations by not requiring separate consent for each child. The group is calling for a moratorium on using foster children in phase 1 and 2 trials.

“That would be a major mistake,” says Ram Yogev, who chairs the PACTG's Primary Therapy Research Agenda Committee. “[Foster] kids should have the same right to get the newest drugs as they are available,” he says. “Otherwise you deny these kids drugs that might elongate their lives.”