http://www.cbc.ca/story/news/national/2003/11/11/Consumers/children_drugs031111.

html More drug trials for children: experts Last Updated Tue, 11 Nov 2003 16:21:34 EST CBC News TORONTO - Doctors have been prescribing drugs to children without adequate research into their effects on them, a group of Canadian doctors said Tuesday. The group for experts published a commentary in Tuesday's edition of the Canadian Medical Association Journal, saying it's time for the same rules that ensure prescription drugs are safe for adults to be applied to children. Doctors have long argued that it's unethical to test drugs on children because they can't give informed consent to enter into a drug trial. But Dr. Michael Rieder, a pediatric clinical pharmacologist at the Children's Hospital of Western Ontario, and three of his colleagues wrote that it may be unethical to prescribe the drugs to children when there's no evidence that they're safe. They also said that children are often the "canary in the coal mine" for new drugs, with adverse reactions showing up in younger patients first. Traditionally, new drugs are tested in animals and then in adult humans. Once a drug is approved, doctors can prescribe them to children. However, the drug's effectiveness and dosage in children can be largely guesswork. An asthma drug called theophylline, Rieder pointed out, actually requires a larger dose per kilogram of body mass in children than it does in adults. Other drugs require a lower dose because the adult dosage would be unsafe for children, he said. Pharmaceutical companies are doing more clinical trials in children for new drugs that come out, Rieder said, mostly because of an American law that extends patent protection on a drug for six months if trials on children are completed. The commentary said the U.S. law has helped to change the field of pharmacology, and similar provisions should be adopted in Canada.