ArticleClinical trials (London, England)2022
On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data.
Article in Clinical trials (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 8 citations in OpenAlex.
- Reframing the Overdose Crisis: Stigma, Industry Influence, and the Politics of Abuse-Deterrent Opioids.International journal of social determinants of health and health services · 2026Article
- Stigma, Scarcity and the Price of Legitimacy: Chronic Pain Advocacy and the Politics of Pharmaceutical Partnerships in Canada.Sociology of health & illness · 2026Article
- Framing, Narratives, and the Overdose Crisis.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2025Article
- Pharmaceutical company responses to Canadian opioid advertising restrictions: A framing analysis.PloS one · 2023Article
- Pills and the damage done: the opioid epidemic as man-made crisis.Frontiers in public health · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
Abstract
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 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, making it unclear how Health Canada concluded that there was no risk of misuse. In our view, these findings underscore the need for transparency of not only of clinical trial data, but also the regulator's interpretation of such data, which is currently lacking in Canada. Furthermore, they 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 surrounding OxyContin.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.