JENNIFER LUDDEN, host:
This is ALL THINGS CONSIDERED from NPR News. I'm Jennifer Ludden.
During the late 1980s and early '90s, researchers included foster children in trials of powerful AIDS drugs. The federally funded trials enlisted HIV-infected foster kids from half a dozen states. These drugs have proven effective in saving the lives of children with HIV, but now there are allegations that those foster children may not have had adequate representation in the trials. The Bush administration and lawmakers on Capitol Hill are investigating. NPR's Audie Cornish has more.
AUDIE CORNISH reporting:
At a House subcommittee hearing, lawmakers tried to get answers to three big questions: Should foster children ever be involved in clinical trials? What protections are now in place for them? And are those protections adequate? The Bush administration thinks the system works.
Mr. DONALD YOUNG (Deputy Secretary, Department of Health and Human Services): Currently we do not see a problem. If one is identified, however, we will look at it and consider ways that we can to improve it.
CORNISH: That's Donald Young. He's a deputy secretary in the Department of Health and Human Services. Young says current federal guidelines are sound, but the department is investigating allegations that raise concerns. This probe and the hearings this past week were sparked by an Associated Press investigation. It found that some of the children never got the independent advocates they were promised, advocates who were supposed to protect the interest of the child. But one doctor who oversaw some of those studies, Alan Fleischman doesn't think that should be an issue.
Dr. ALAN FLEISCHMAN (Ethicist; Professor of Pediatrics): There were lots of procedural safeguards to protect those children. Those children's lives were saved and enhanced, and yet the media seems to talk about it as if they were used, as if they were inappropriately enrolled in trials. And there are all kinds of innuendos as to why. I think that saddens me.
CORNISH: Fleischman is an ethicist and professor of pediatrics in New York. Some 15 years ago he sat on some of the institutional review boards charged with overseeing AIDS drug trials in the Bronx. These boards are made up of independent researchers who monitor the studies. Fleischman says researchers didn't use advocates because they weren't necessarily required to. He says the only time advocates are mandated is when the risks are significant and there's no chance the child will benefit from the drug. But Roberta Harris of the social services department in Wisconsin, disagrees.
Ms. ROBERTA HARRIS (Social Services Department, Wisconsin): The determination of whether research carries minimal risk and the child would directly benefit is subjective. Who makes that determination? What are the criteria? That's one of the questions, I think, that is unanswered.
CORNISH: Wisconsin didn't participate in these trials and has strict rules regulating the involvement of foster children. With no foster children or foster parents asked to testify, Harris was the only person lawmakers heard from who wasn't a doctor. She argues that the review boards don't always include a voice for children. And that's a problem for Congressman Pete Stark, a California Democrat.
Representative PETE STARK (Democrat, California): We do it for prisoners. Every prisoner must, by federal law, have an advocate. I'm saying we could do the same thing for children--it's a simple change in the law--to make sure that any foster child has that advocate on the review board.
CORNISH: The Health and Human Services Department says every state has different rules about who's allowed to say yes or no to a clinical trial on behalf of a foster child. Review boards may be bound by federal guidelines, but they're set up by the hospital or school running the trial and are only periodically monitored. For now it's unclear whether any legislation will come out of these investigations. The House Ways and Means Subcommittee will continue to accept testimony over the next two weeks.
Audie Cornish, NPR News, Washington.
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