Unlocking Health Canada's cache of trade secrets: mandatory disclosure of clinical trial results

摘要

Health Canada should publicly disclose information about the safety and efficacy of Pharmaceuticals, biologies and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust, address weaknesses in the evidence base and protect Canadians from harm. A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada also did not publicly disclose that evidence, and by 2004 SSRIs were being widely prescribed for teenagers. Physicians had no idea they were invoking their discretion to prescribe "off label" on the basis of incomplete information - the balance of which Health Canada had in hand.