AIDS Drugs Tested On Foster Kids

Researchers Tested Drugs On Kids Without Advocate Protection

(AP) 
Research and foster agencies declined to make foster parents or children in the drug trials available for interviews, or to provide information about individual drug dosages, side effects or deaths, citing medical privacy laws.

Other families who participated in the same drug trials told AP their children mostly benefited but parents needed to carefully monitor potential side effects. Foster children, they said, need the added protection of an independent advocate.

"I don't believe a foster care parent can do it," said Vinnie DiPoalo, a New Jersey woman whose 10-year-old adopted son has participated in three AIDS drug trials. "There are informed consents that have to be signed. There are follow-up blood appointments.

"I think that's the role the advocate should take, because a foster parent may only have this child for three months and then the child moves on and someone needs to be watching all the time," she said.

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 AIDS but can cause bad reactions like rashes and organ damage.

Some of those drugs were approved ultimately for children, such as stavudine and zidovudine. Other medicines were not.

Illinois officials confirmed two or three foster children were approved to participate in a mid-1990s study of dapsone. Researchers hoped the drug would prevent a pneumonia that afflicts AIDS patients.

Researchers reported some children had to be taken off the drug because of "serious toxicity," others developed rashes, and the rates of death and blood toxicity were significantly higher in children who took the medicine daily, rather than weekly.

At least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn't appear to be "directly attributable" to dapsone but nonetheless were "disturbing."

"An unexpected finding in our study was that overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained," the researchers concluded.

Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Among 52 children, there were 26 moderate to severe reactions - nearly all in infants. The side effects included rash, fever and a major drop in infection-fighting white blood cells.

New York City officials defend the decision to enlist foster children en masse, saying there was a crisis in the early 1990s and research provided the best treatment possibilities. Nonetheless, they are changing their policy so they no longer give blanket permission to enroll children in preapproved studies.

"We learned some things from our experience," said Elizabeth Roberts, assistant commissioner for child and family health at the Administration for Children's Services. "It is a more individualized review we will be conducting."

Researchers likewise defend their work, saying they often sat with foster families to explain the risks and benefits, and provided them literature and 24-hour phone numbers.

"We talk about it. Then they come the next time. There is no rush," explained Dr. Ram Yogev, the chief pediatric AIDS researcher in Chicago whose patients include a large number of foster children.

Kline, the Texas researcher, added: "I never wanted a parent or guardian to ever say 'yes' simply because they thought that it was what I wanted them to do. I wanted it to be the right choice for them. I think there is not any single right answer for any family."