Morrow, Richard L. http://orcid.org/0000-0002-5869-5197
Mintzes, Barbara
Souverein, Patrick C.
Hallgreen, Christine E.
Ahmed, Bilal
Roughead, Elizabeth E.
De Bruin, Marie L.
Kristiansen, Sarah Brøgger
Lexchin, Joel
Kemp-Casey, Anna
Sketris, Ingrid
Mangin, Dee
Pearson, Sallie-Anne
Puil, Lorri
Lopert, Ruth
Bero, Lisa
Gnjidic, Danijela
Sarpatwari, Ameet
Dormuth, Colin R.
Funding for this research was provided by:
Canadian Institutes of Health Research (PJT–153275)
National Health and Medical Research Council (1122332)
Article History
Accepted: 13 March 2022
First Online: 19 April 2022
Declarations
:
: This work was funded by grants from the Canadian Institutes of Health Research (CIHR; PJT–153275) and the Australian Government National Health and Medical Research Council (NHMRC; 1122332). Ameet Sarpatwari’s work is also funded by Arnold Ventures.
: The funders had no role in the study design; the collection, analysis or interpretation of data; writing the manuscript; or in the decision to submit the manuscript for publication.
: The authors declare that grants from the CIHR and Australia’s NHMRC supported this work. Joel Lexchin declares payments from the CIHR, the Toronto Public Library and from lawyers acting on behalf of clients allegedly affected by adverse drug reactions. Marie L. De Bruin and Christine E. Hallgreen declare PhD grants from Novo Nordisk, Lundbeck, Ferring Pharmaceuticals, and LEO Pharma to the Copenhagen Centre for Regulatory Science. Barbara Mintzes is acting as an expert witness for Health Canada on a legal case and anticipates future payment for doing so. Sallie-Anne Pearson declares the Centre for Big Data Research in Health received funding for postmarket surveillance research, unrelated to the current study. Lorri Puil has received a Michael Smith Foundation for Health Research Reach Grant. Ameet Sarpatwari declares grants or contracts from Arnold Ventures, and the US FDA paid, to his institution, consulting fees from West Health, and payment for expert testimony from the American Civil Liberties Union (ACLU). Ingrid Sketris has received a CIHR Canadian Network for Observational Drug Effect Studies grant and a Drug Evaluation Alliance of Nova Scotia grant, as well as payment for serving as a member of the Patented Medicine Prices Review Board. Richard L. Morrow, Patrick C. Souverein, Bilal Ahmed, Elizabeth E. Roughead, Sarah Brøgger Kristiansen, Anna Kemp-Casey, Dee Mangin, Ruth Lopert, Lisa Bero, Danijela Gnjidic, and Colin R. Dormuth report no conflicts of interest and all authors declare no other relationships or activities that could appear to have influenced the submitted work.
: The authors are unable to share data used for this study due to a lack of data permissions for this purpose.
: Programming code is unavailable.
: Research ethics board approval was obtained from the University of British Columbia Clinical Research Ethics Board (H20-00929). In addition, the CPRD has received ethics approval from the NHS Health Research Authority to support research using anonymized patient data.
: Informed consent was unnecessary as the study used only secondary administrative health data, which had been de-identified prior to data access.
: Not applicable.
: CD and RM had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Conception and design: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. Acquisition, analysis or interpretation of data: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. Drafting of the manuscript: RM. Critical revision of the manuscript: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. Statistical analysis: CD and RM. Obtaining funding: CD, SP, BM, RL, DM, CEH, MLDB, LP, ER, IS, JL, LB, PCS, AS and DG. Supervision: CD and BM. Final approval of version to be published: CD, SP, BM, AK-C, RL, DM, CEH, MLDB, LP, ER, RM, IS, JL, LB, PCS, AS, BA, SBK, and DG. All authors agree to be accountable to all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.