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PLAN TO TEST PRESCRIPTION STIMULANT
Experts question ethics
BY KATHLEEN KERR STAFF WRITER
August 20, 2004
A government plan to test the effects of a prescription stimulant on children's brains has triggered a rare request for a special review to determine whether it meets safety and ethical guidelines.
Researchers at the National Institute of Mental Health in Bethesda, Md., want to test the effects of a single 10 milligram dose of dextroamphetamine on brain activity in at least 76 children, ages 9 to 18. All the children would receive a placebo, a dummy pill containing no drugs on their first visit; subsequently, they would receive the dextroamphetamine.
Dextroamphetamine is already used to treat some children with attention deficit problems. The brand name drug, Dexedrine, is one example of a pill that contains dextroamphetamine.
The study would test the drug both in children with attention deficit hyperactivity disorder and in a control group of healthy children. Children already receiving stimulants would be asked to stop using them before participating in the study.
Researchers hope to determine whether differences in brain activity between children with ADHD and healthy children are caused by the symptoms of the disorder or by genes that affect brain activity. Some symptoms of ADHD include an inability to concentrate on certain tasks, difficulties in following instructions and organizing work, hyperactivity, excessive talking and impulsive actions. But the symptoms alone do not mean a child has ADHD.
Question of ethics
But experts in medical ethics and health law have questioned some aspects of the proposed research.
"The general rule is you don't do research on kids this young," said Leonard Glantz, a health law professor at the Boston University School of Public Health, in an interview. "The question is how important is this information, how vital?"
Board disapproves
An institutional review board - questioning the safety of the research and the $570 each child would receive for participating in the study - voted 6-5 last fall not to approve it. The board determined that while the proposal would not benefit the children, it did have scientific merit.
As a result, the proposal was referred to a Department of Health and Human Services panel, which can approve risky research if it offers a way to understand, prevent or alleviate a serious problem affecting children's health. The panel has not yet rendered a decision.
Alan Sandler, director of the Office of Human Subjects Research at the National Institutes of Health, couldn't recall another time when an NIH research proposal required a special department review. The mental health institute is a branch of NIH.
Risky research
Cliff Zucker, director of the Albany-based Disability Advocates, a nonprofit group often involved in mental health issues, said the fee the children would receive could serve as a lure to entice needy families to participate in risky research.
"I think $570 sounds like a lot," Zucker said. "Why would any parent let his child do this?"
Thomas Murray, president of the Hastings Center, a bioethics think tank in Garrison, N.Y., yesterday raised a concern also voiced by some members of the review board, according to meeting minutes reviewed by Newsday.
"If kids enjoy the experience, it may incline them toward trying other families of drugs," Murray said. "That would be a concern."
Money matters
Like Zucker, Murray also questioned the $570 payments the children would receive. "What you want to avoid is parents throwing their children into this because they want the dough," Murray said, emphasizing that it is important that researchers disclose the communities in which they will seek participants.
The lead researcher, Dr. Judith Rapoport, would not comment on the proposal and would not say where she plans to find children to participate.
Common side effects of low doses of dextroamphetamine are insomnia and appetite loss.
HHS and Food and Drug Administration officials plan a Sept. 10 public meeting on the issues. FDA is involved because it regulates prescription drugs. The HHS special review panel and the FDA must both approve the research.
Copyright � 2004, Newsday, Inc.
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