Medical student questions how Health Canada licensed OxyContin

Medical student questions how Health Canada licensed OxyContin

Medical student questions how Health Canada licensed OxyContin

By Jessie Pappin

Students at Dalhousie Medical School must pass a mandatory longitudinal course, Research in Medicine, to graduate. This course has a double focus to:

  1. Help medical students develop and refine skills for critical consumption of research evidence;
  2. Engage students in experiential learning through development of our own research projects.

The recently published article, On what basis did Health Canada approve OxyContin in 1996?: A retrospective analysis of regulatory data emerged from my Research in Medicine experience, thanks to the help of my preceptor, Dr. Matthew Herder of the Dalhousie Health Law Institute.

We utilized a recently created online database containing information pertaining to the safety and effectiveness of drugs to conduct a retrospective analysis of Purdue Pharma’s OxyContin (controlled release oxycodone) submission to Health Canada, including both published and unpublished clinical trials.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 of misuse or addiction associated with OxyContin. The trials were short in duration (maximum length was 24 days) and only assessed safety and efficacy of a 12-h dosing interval. Also, the two trial reports that explicitly mentioned (but did not formally evaluate) the risk of misuse were not published. It is unclear how Health Canada concluded that there was no risk of misuse.

These findings underscore the need for transparency not only of clinical trial data, but also how the regulator interprets such data, both currently lacking in Canada. They also call into question why Health Canada’s role in precipitating the overdose crisis has not received greater scrutiny, including in the context of recent litigation over the promotion of OxyContin.

Participating in this research project and writing the published report provided me with a unique experience, different from my previous research. It led me to assess critically the very department (Health Canada) and practices that control how I will practice medicine in the future. I began to appreciate the tangible evidence of the harm and destruction that can arise from such practices.

As medical students and future physicians, we are encouraged to be critical about validity, efficacy, and many other elements of the practices we are taught. But rarely are we provided with any raw evidence. Instead we are instructed by various professors what to learn and believe: ideas and practices which may be evidence based, but may also be tainted by our teachers’ own biases and relationships. As students, we are malleable – susceptible to falling into the same pattern of bias as those teaching us.

This retrospective investigation of how Health Canada came to license OxyContin in 1996 demanded that I delve thoroughly into research reports and ‘evidence’, coming to my own conclusions and opinions. It forced me to ask questions, rather than assume that Health Canada and practicing physicians have only patient health in mind, free of bias, pecuniary or political motivations.

Our analysis of OxyContin’s licensing in Canada is retrospective, and the consequences – the opioid crisis – cannot now be avoided. But the need we identify for transparency within the healthcare system is crucial for the future. I will continue to ask questions and form my own evidence-based opinions, and I encourage other medical students to do the same. I consider this important not only to promote high quality healthcare, but also to exercise our skills in critical analysis and questioning, in order to promote growth in our understanding of medical science.

Jessie Pappin is a 4th year medical student at Dalhousie University, Halifax, NS.

Do YOU have any thoughts about this issue?

We will consider posting brief responses if accompanied by name and affiliation and a completed ICMJE conflict of interest declaration available here:

  • Rupa Patel MD, CCFP, FCFP
    Posted at 08:22h, 30 August Reply

    Thank you for this work! We have many lessons to learn from the OxyContin debacle, which continues to plague health care. The trial data that allowed claims such as “there is no addiction”, “doses can be escalated without problems” were not based on any legitimate data. Yet, many “experts” promoted these claims and had career advancement with their industry-influenced work. Physicians lack rigor when evaluating information and have become pawns for industry.

    Rupa Patel MD, CCFP, FCFP
    Kingston Community Health Center
    Assistant Professor
    Queens University Department of Family Medicine
    Director Women’s Health Program

    Dr. Patel declares no conflict of interest.

  • Marc Clark MD CCFP FCFP
    Posted at 09:40h, 30 August Reply

    It’s wonderful to see a student point out that our regulatory emperor has very few clothes. I would caution that after the child in Andersen’s story calls out the emperor’s nakedness, he continues to walk on “more proudly than ever”. Worse, the emperor’s courtiers upheld the pretence. Let’s hope that we can do better.
    Mark Clark, MD, CCFP, FCFP
    Edmonton, Alberta

    Dr. Mark Clark has submitted a ICMJE disclosure form showing no conflicts of interest.

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