Canada’s prescription for trouble – Our children are given drugs not tested adequately for their age group – if at all — (Montreal Gazette)

To view original article click here

Montreal Gazette

SHARON KIRKEY, CanWest News Service

Tuesday, February 01, 2005

In early December 2003, Gordon Mitchell was on a family vacation in Puerto Vallarta, Mexico. The 16-year-old was in his element, displaying his athletic skills as he swung his strong, young body from cables in the trees in the foothills of the Sierra Madre mountains.

At Christmas that year, Gordon was laughing and joking with his cousins and teasing his grandmother, a woman with an instinct for kids who let him smear face paint on her cheeks and eat Mr. Freezes for supper when he was little.

Four days after Christmas, his parents and little sister Kaitlyn left their home in Olds, Alta., for a swim at the nearby leisure centre.

Gordon Mitchell stayed home, and killed himself.

Gordon had been taking Paxil, an antidepressant his doctors prescribed for anxiety. Although he had stopped taking it about two months before he took his life, the medical examiner’s report revealed Paxil could still be detected in Gordon’s body.

The drug has since been hit with mandatory warnings of a possible increased risk of suicidal thinking and “self-harm” in children and adolescents, and a British ban on its use by anyone under 18.

Gordon’s parents were not told the antidepressant has never been licensed for use by children in Canada or that it was being prescribed “off label” – meaning for purposes not approved by Health Canada.

Nor were they told that its prescribing information cautioned doctors “safety and effectiveness in children under 18 have not been established.”

Thousands of times a day in Canada, a child is drugged with a pill, syrup or lotion that hasn’t been adequately tested on children, if at all. Drug labels frequently provide doctors with little or no information on effectiveness, age-appropriate dose or safety in youngsters, especially for children under age 2.

Now, after years of glacial progress (compared with the United States and European countries), Canada is moving to improve drug investigation in children.

Health Canada is proposing to give pharmaceutical companies an extra six months of “market exclusivity” – which prevents a generic version of a drug from coming on the market – to encourage them into testing a new drug on “pediatric age groups” – from premature babies to 17-year-olds – if the drug is likely to be used in children.

A similar provision adopted by U.S. drug regulators six years ago has led to safety and dosing labelling changes on at least 40 drugs – and charges from the Alliance for Human Research Protection that children are being exploited for profit and exposed to pain – and potentially harmful medicines – in the name of assembling “good clinical data” even if the drug offers them no potential benefit.

In a separate development, an $8.4-million, nationwide project partly funded by Genome Canada will be launched today that could make drug use for children safer worldwide. At least seven children’s hospitals will join to monitor and report adverse reactions to drugs in children, from rashes to drug-induced hepatitis and Stevens-Johnson Syndrome, a rare and potentially fatal blistering, burning allergic reaction.