Ronn!Blankenship <[EMAIL PROTECTED]> wrote:
>
<<http://www.newsday.com/news/health/ny-hsexp203936261aug20,0,365506.story>>
>
> PLAN TO TEST PRESCRIPTION STIMULANT
> 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.
<snip>
> 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?"
>
> 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.
<snip>
> 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.
This seems dark grey to me. It is one thing to test a
potentially helpful drug on children with a medical
condition and, as a control group, use a placebo on
another group of children with the same condition
(preferably with a crossover at the end of one phase
of the trial); it is another to give a potentially
harmful drug to healthy children (without any medical
condition).
While there are some children who truly benefit from
ritalin-type drug therapy, I do think that ADD/ADHD is
vastly over-diagnosed. Subjecting hyperactive
toddlers to years of brain-chemical-altering drugs, as
is occurring 'in the field' right now, may
unfortunately tell us quite a lot about these drugs'
long-term effects in a decade or so... >:/
Debbi
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