[WhollyViber] FDA Considers Experimenting on Healthy Kids

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Misty L. Trepke

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FDA considers experimenting on healthy kids

http://www.msnbc.msn.com/id/5907667

 

Study hopes to better understand ADHD in children The Associated

Press Updated: 4:43 p.m. ET Sept. 3, 2004WASHINGTON - 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.

 

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 experts 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 mg. or as much as 30 mg.

 

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.

 

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. They kicked the sensitive matter over 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.

 

Comparing twins — one with ADHD, the other normal — helps

researchers tease out genetic explanations of differences in

response to treatment.

 

In September 2003, an NIMH panel that reviewed the proposal's

scientific merit called the program an excellent submission. The

panel noted that it would be the first ADHD study to compare twins,

which has been useful in past studies on schizophrenia.

 

The panel that considers a safety of human subjects, however, was

troubled by the youngest tested children's age and the potential for

coercion because each participant would be paid $570 for the 11-hour

study.

 

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.

 

Healthy kids face some risks

The most common side effects among healthy children given a single

dose of the stimulant in past experiments was temporary insomnia and

poor appetite. One brain-damaged child exposed to the medication

suffered hallucinations.

 

Many ethicists expect the FDA subcommittee to use a primary litmus

test: Does taking the stimulant pose more than a minimal increase to

risks that healthy children face in everyday life?

 

Pearl O'Rourke, who oversees human research affairs, interviewed the

heads of six review boards at Massachusetts General 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.

 

O'Rourke acknowledged that the review boards struggle with murky

federal regulations, tightening case law, financing agencies that

prefer pediatric studies and the threat of negative media coverage.

 

" I live in dread fear of what's going to be on the front page of the

paper, " she told the audience. " So, when I heard this, three things

hit my mind: Kids, ohmigod! Psychiatric disease. And a class 2 drug. "

 

The FDA panel could simply approve the plan if it should find it

carried great scientific weight, said Dr. Douglas Diekema, director

of medical ethics at Children's Hospital in Seattle.

 

New Jersey attorney Alan C. Milstein said that would be the wrong

call.

 

Milstein, who represented the family of an 18-year-old whose death

in 1999 spurred greater federal oversight of gene therapy trials,

pointed to a recent Maryland Supreme Court ruling. The court held

that exposing healthy children to higher-than-minimum risk in a

medical study is unethical.

 

" They can't do this study. It doesn't take a genius to figure out

why they can't do it, " Milstein said. " I can't believe that anybody

is going to say it's ethical to do this. It's not even a close call. "

 

© 2004 The Associated Press. All rights reserved.