Inductive Risk and OxyContin: The Ethics of Evidence and Post-Market Surveillance of Pharmaceuticals in Canada

The argument from inductive risk claims that judgments about the moral severity of errors are relevant to decisions about what should count as sufficient evidence for accepting claims. While this idea has been explored in connection with evidence required for the approval of pharmaceuticals, the role of inductive risk in the post-approval process has been largely neglected. In this article, we examine the ethics of inductive risk in connection with revisions to the product monograph for OxyContin in Canada, which understates the risks of addiction and abuse associated with this drug. Using the concept of inductive risk, we consider what evidence should have been sufficient for Health Canada (HC) to revise the product monograph for OxyContin. Given the stakes involved, we argue that a less strict standard of evidence would have been appropriate, yet HC in fact took the opposite course, insisting upon a higher standard of evidence than it normally requires. In addition to providing a novel perspective on the opioid crisis in Canada, this article contributes to existing philosophical work by demonstrating that inductive risks in the post-approval stage are important and linked to pre-approval inductive risks.

Off-label infusion of biosimilar bevacizumab: A provincial experience

The product monograph for reference bevacizumab (Avastin) and biosimilar bevacizumab (Mvasi) recommend to infuse the first dose of bevacizumab over 90 min, second dose over 60 min and third and subsequent doses over 30 min. Despite the product monograph recommendations, many institutions adopted an accelerated bevacizumab (Avastin) 0.5 mg/kg/min infusion time. Our province adopted the accelerated infusion time at time of biosimilar bevacizumab (Mvasi) adoption. Our experience with the accelerated infusion time was well tolerated in the first five months of biosimilar bevacizumab adoption across different tumor types.

A real-world observational study of somatostatin analogue use and costs in Canada.

608 Background: Somatostatin analogue (SSA) use is indicated in acromegaly and neuroendocrine tumours for symptomatic relief and tumour control. Two long-acting SSAs (lanreotide and octreotide) are currently available, but comparative real-world data on their use are limited. This study evaluated SSA use and costs in Canada. Methods: Claims data from the IQVIA Private Drug Plan (PDP), Ontario Drug Benefit (ODB) program and Régie de l’assurance-maladie du Québec (RAMQ) were compiled. Injection burden, rescue medication use and costs were compared (using unpaired t-test or Wilcoxon test) over a 12-month period from first SSA prescription. Patients (pts) were eligible if the first prescription was dispensed Sept. 2015–Jun. 2018. Results: 908 pts were included: lanreotide 120 mg, N=375; octreotide long-acting release (LAR) 30 mg, N=533. Lanreotide treatment was associated with a lower weighted average injection burden for 12 months when compared to octreotide (12.54 vs 13.44 injections/pt, respectively; p<0.0001). Pts receiving lanreotide also had lower mean use of rescue medications than those treated with octreotide (0.01 vs 0.05 claims/pt/year), although this difference was greatest during the first month of treatment (mean difference: 0.19; p<0.0001), after which differences in rescue medication use were only significant (p<0.05) at Months 5 and 6. Mean total annual costs (rescue medication + LAR) were lower for lanreotide than octreotide ($27,829.35/pt [N=373] vs $31,255.49/pt [N=530], respectively, p<0.0001). Conclusions: In the absence of clinical trials directly comparing the SSAs, factors driving treatment selection are unclear. Findings from our real-world observational study suggest treatment with lanreotide to be less burdensome and costly than octreotide and may inform treatment discussions with pts. References1. Ipsen Biopharmaceuticals. Somatuline Autogel Product Monograph. 2018. Available at: https://cnetscanada.org/wp-content/uploads/2018/06/Somatuline-Product-Monograph.pdf; 2. Novartis Pharmaceuticals Canada Inc. Sandostatin LAR Product Monograph. 2018. Available at: http://www.ask.novartispharma.ca/download.htm?res=sandostatin_scrip_e.pdf&resTitleId=789.