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On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder
On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder
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The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks …