Antidepressant no more effective than placebo in kids: report
Last Updated Fri, 13 Feb 2004 13:41:33
TORONTO - A drug company withheld crucial clinical trial results indicating the anti-depressant drug Paxil has no benefits for children, according to a confidential internal document.The document was published Thursday in a report in the Canadian Medical Association Journal. The document acknowledges that clinical trial results were "insufficiently robust" to back up an application to use Paxil to treat depression in people under the age of 18.
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Health Canada recently issued a warning about the drug, along with seven other antidepressants like it, that it was no more effective in children than a sugar pill. Health Canada also warned that in some cases, the drugs did more harm than good.
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Antidepressants have never been labelled for use in children in Canada. But some doctors do prescribe. The internal memo said only positive findings would be reported from a clinical trial conducted by the company - GlaxoSmithKline - in the United States, which found the drug was no more effective in children than a placebo.
Companies applying for drug licensing in Canada put together a list of data to support their application. They're free to pick and choose which data to include. It's up to Health Canada to review the information and determine whether to approve the drug. Health Canada says the company did nothing wrong in this case. But critics say if a company is allowed to keep secret negative findings in clinical trials, that shows there are problems with the drug regulatory system. Written by CBC News Online staff