PRESCRIBING UNTESTED DRUGS TO CHILDREN

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Friday, April 05, 2002 9:52 PM

PRESCRIBING UNTESTED DRUGS TO CHILDREN

 

 

- http://www.redflagsweekly.com/regush/untested_drugs.html -

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PRESCRIBING UNTESTED DRUGS TO CHILDREN

 

By Nicholas Regush

 

The FDA has decided to suspend a 1997 federal rule that requires drug companies

to conduct tests on children to establish whether drugs are safe and effective

for them. The agency says it plans to study whether the rule is still necessary.

 

This move has angered pediatric and consumer groups because it is now expected

that many more drugs will be prescribed to children without knowledge of any

potential harmful effects. This will force physicians to often guess which drugs

tested in adults will also be suitable for use in children.

 

Companies already have an incentive to do research in children because they

receive — courtesy of Congress — a six-month patent extension on a particular

drug. So the drug industry believes that this will keep companies motivated to

test new drugs in children.

 

Critics of the FDA move counter that such an incentive alone does not bring

about sufficient testing and that doctors will often remain in the dark about

how a particular drug may work in children and how much dosage is required for

it to be beneficial or harmful. According to some politicians, including Sen.

Edward M. Kennedy, the FDA decision makes no sense.

 

But there is much more to this issue than is being reported. According to Vera

Hassner Sharav of the Alliance for Human Research Protection, the 1997 federal

rule should have required the FDA or the Department of Health and Human Services

to conduct an impact study " to determine whether, and how, children would be

affected adversely " by entering clinical drug tests. Hassner says that, " It is

most disturbing that neither the administration nor Congress has seen fit to

request an annual report detailing information about pediatric research in order

to ensure that children are not being harmed or exploited. Congress does mandate

detailed annual reports about the conduct of animal research. Animals are

protected under the Animal Welfare Act of 1966; children who are recruited into

clinical trials — with cash payments to parents — are unprotected. "

 

The rule suspension by the FDA should obviously not be the only concern voiced

about drug testing in children.

 

 

 

 

 

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