FDA may use healthy children as guinea pigs in experiments with mind-altering drugs

A similar experiment was performed 20 years ago by the National Institute of Health, but they did not have access to MRI technology to measure effects on the brain, which will be used in this new study if it is approved.

• 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 on Sept. 10.
• The research, proposed by the National Institute of Mental Health, includes healthy children among 9- to 18-year-olds who would receive a single 10 mg. 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.
• Characterized by inattentiveness, overactivity and impulsiveness, ADHD affects up to 5 percent of schoolchildren.
• Dextroamphetamine, the active ingredient in such drugs as Dexedrine and Adderall, is prescribed commonly to increase attention span and calm restlessness.
• Researchers looked only at how the stimulant changed children's behavior as they performed tasks.
• The new trial would add magnetic resonance images to map potential differences in brain activation patterns.
• Risk vs. scientific gain While Rapoport's trial is little different from the earlier one, review boards that balance risk vs. scientific gain have changed dramatically in 20 years.
• Indeed, an NIH review panel met twice and was unable to reach a consensus whether risk to healthy volunteers would be too high in the new study.
• The study would involve 14 children with ADHD, 14 healthy children, 12 pairs of identical twins and 12 pairs of fraternal twins.
• The major stumbling block was determined to be the risk of giving a class 2 controlled substance to healthy children, which some fretted might breed future substance abuse.
• Children in the 1980 NIH trial had no increased risk of drug abuse in the five years after the trial ended, researchers say in the study protocol.