PRESCRIPTION DRUG TESTING LAWS NOT PROTECTING CHILDREN

For too long children have been "sentinel canaries" when it comes to
prescription drugs, with regulating authorities requiring little or no
verification that drugs are safe for children before they are used, a group
of experts is arguing.

In a commentary published today in the Canadian Medical Association
Journal, they say it's time for the evidence-based medicine rules that are
used to ensure prescription drugs are safe for adults to be applied to
children.

"We live in a world of rules. And I think parents would not unnaturally
assume that the rules that apply to drug approvals for them are the same as
.. for their kids. And they would be wrong," Dr. Michael Rieder, a
pediatric clinical pharmacologist, said in an interview yesterday.

It is often argued that it is unethical to test pharmaceuticals in
children, both because they cannot give informed consent and because there
may be more risk of harm from drugs during the early stages of life.

Rieder and three colleagues from the Children's Hospital of Western Ontario
turn that argument around, however, suggesting it may be unethical to
prescribe drugs to children if there is no evidence the drugs are safe in
this vulnerable population.

"If you look at the adverse drug reaction literature, kids have been the
sentinel canary for a lot of bad things in drug theory for quite some time.
And I would argue that's not the best segment of society who should be
serving that function," he said.

Traditionally, new drugs are tested first in animals, then in adult humans.
Once they are licensed for use, however, doctors can and do prescribe them
to children -- but without the benefit of clinical data to show if they
will be effective or what the appropriate dosage should be.

That is largely guesswork. And it isn't always right. Rieder noted a drug
called theophylline, once commonly used in the treatment of asthma, was
prescribed for some time in children before it was realized that it wasn't
working. It turned out that kilogram for kilogram, children required higher
doses of the drug than adults. With other drugs, adult doses are unsafe for
children.

While pediatric drug trials are growing, this work is mainly done on new drugs.

In part that's because of a U.S. provision that grants drug manufacturers
an extra six months of patent protection for a drug if it is tested in
children.

But as yet no similar provision has been adopted here.