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FDA considers ethics of child stimulant tests

WASHINGTON -- Is it ethical in the name of science to give a healthy child as young as 9 a controlled substance? That's the dilemma facing the Food and Drug Administration's Pediatric Ethics subcommittee at its first-ever meeting next Friday.

The research, proposed by the National Institute of Mental Health, includes healthy children between 9 and 18 years old who would receive a single 10-milligram dose of dextroamphetamine.

The hoped-for payoff for research: A better understanding of how healthy brains work differently from those of children diagnosed with attention deficit hyperactivity disorder.

The payoff for families: $570.

Characterized by inattentiveness, overactivity, and impulsiveness, ADHD affects up to 5 percent of schoolchildren. The disorder continues in roughly 60 percent of those youths as they age, although specialists say the disorder is underdiagnosed in adults.

Dextroamphetamine, the active ingredient in such drugs as Dexedrine and Adderall, is prescribed commonly to increase attention span and calm restlessness. Doses vary with children's needs, with daily doses as little as 5 milligrams or as much as 30 milligrams.

Judith L. Rapoport, chief of child psychology at NIMH, within the National Institutes of Health, conducted a similar trial 20 years ago. The same stimulant was given to children at a higher dose. Researchers looked only at how the stimulant changed children's behavior as they performed tasks. The stimulant improved attention span in the children, regardless of whether they had ADHD.

The new trial would add magnetic resonance images to map potential differences in brain activation patterns.

An NIH review panel met twice and was unable to reach a consensus on whether the risk to healthy volunteers would be too high in the new study. They sent the sensitive matter to the FDA's new pediatrics ethics subcommittee.

The study would involve 14 children with ADHD, 14 healthy children, 12 pairs of identical twins and 12 pairs of fraternal twins. As the children completed specified tasks, their brain activity would be captured by MRIs.

Pearl O'Rourke, who oversees human research affairs, interviewed the heads of six review boards at Massachusetts General Hospital and Brigham and Women's Hospital.

''Five said they would not approve this study. And all five said, 'But we wish we could,' " O'Rourke said during a March 3 NIH discussion.

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