Joel Lexchin

Dr. Lexchin has been writing and publishing about pharmaceutical policy issues for the past 30 years. He is the author or co-author of over 140 peer-reviewed papers on a wide range of topics in this area, including: drug regulation, pharmacosurveillance, drug promotion, research and development, access to medications in developing countries and physician prescribing behaviour. He has been a consultant on these and other issues to the Ontario provincial government, various parts of the Canadian federal government, the government of New Zealand, the Australian National Prescribing Service and the World Health Organization.

Recent Publications

Peer-Reviewed Books

Lexchin J. Private profits vs Public Policy: The Pharmaceutical Industry and the Canadian State. Toronto: University of Toronto Press, 2016.

Peer-Reviewed Book Chapters

Lexchin J. The pharmaceutical industry in the context of contemporary capitalism. In: Waitzkin H ed. Health care under the knife: moving beyond capitalism for our health. New York: Monthly Review Press, 2018:83-98.

Lexchin J. The pharmaceutical industry and Health Canada: values in conflict. In: Germov J, Hornosty J eds. Second opinion: an introduction to health sociology, second Canadian edition. Toronto: Oxford University Press, 2016:308-327.

Lexchin J. Drug pricing in Canada. In: Babar Z-U-D ed. Pharmaceutical prices in the 21st century. Springer International Publishing Switzerland. 2015:25-41.

Peer-Reviewed Publications

Gorfinkel I, Lexchin J. Enabling patient portals to access primary care medical records: maximizing collaboration in care between patients and providers. Healthcare Policy 2019;14(4):21-27.

Lexchin J. Increase in drug spending in Canada due to extension of data protection for biologics: a descriptive study. Healthcare Policy 2019;14(3):10-18.

Torka M, Mintzes B, Bhasale A, Fabbri A, Perry L, Lexchin J. Secret safety warnings on medicines: a case study of information access requests. Pharmacoepidemiology and Drug Safety 2019;28:551-555.

Lexchin J. Association between commercial funding of Canadian patient groups and their views about funding of medicines: an observational study. PLoS One 2019;14:e0212399.

Ågotnes G, McGregor MJ, Lexchin J, Doupe MB, Müller B, Harrington C. An international mapping of medical care in nursing homes. Health Services Insights 2019;12:1-12

Lexchin J. Health Canada’s use of its Notice of Compliance with Conditions drug approval policy: a retrospective cohort analysis. International Journal of Health Services 2019:49:294-305

Lexchin J. Cost recovery by Health Canada and drug safety: a time-series analysis. CMAJ Open 2018;6:E471-477

Schiff GD, Martin SA, Eidelman DH, Volk LA, Ruan E, Cassel C, Galanter W, Johnson M, Jutel A, Kroenke K, Lambert BL, Lexchin J, Myers S, Miller A, Mushlin S, Sanders L, Sheikh A. Ten principles for more conservative, care-full diagnosis. Annals of Internal Medicine 2018:169:643-645.

Lexchin J. Canadian status of “drugs to avoid” in 2017: a descriptive analysis. CMAJ Open 2018;6:E430-E435.

Lexchin J. Health Canada’s use of expedited review pathways and therapeutic innovation, 1995-2016: cross-sectional analysis. BMJ Open 2018;8:e023605.

Lexchin J, Menkes DB. Can direct-to-consumer advertising of prescription drugs be effectively regulated? New Zealand Journal of Medicine 2019;132:59-65. https://www.ncbi.nlm.nih.gov/pubmed/31170134

Braillon A, Lexchin J. Innovation and off-label use, the French case and more. British Journal of Clinical Pharmacology 2019. https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.13993

Lexchin J. Declarations of interest by members of Health Canada’s special advisory committees and panels: a descriptive study. CMAJ Open 2019;7:E334-340. http://cmajopen.ca/content/7/2/E334.full

Perry LT, Bhasale A, Fabbri A, Lexchin J, Puil L, Joarder M, Mintzes B. Comparative analysis of medicines safety advisories released by Australia, Canada, the United States and the United Kingdom. JAMA Internal Medicine 2019; published on-line April 29. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2731707

Lexchin J. Pharmaceutical industry-initiated postapproval studies – not requested by the US FDA, little value, and many questions. JAMA Network Open 2019;2(5):e193392. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2733165

Lexchin J, Herder M, Doshi P. Canada finally opens up data on new drugs and devices: other regulators should take note of Health Canada’s substantive reforms. BMJ 2019;365:l1825. https://doi.org/10.1136/bmj.l1825

Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive Care Medicine 2018: https://doi.org/10.1007/s00134-018-5293-7

Grootendorst P, Shim M, Falconi A, Robinson T, Lexchin J. Intellectual property protection and drug plan coverage: evidence from Ontario. International Journal of Health Services 2018

Gorkinkel I, Lexchin J. A call to mandate patient access to personal primary care medical records across Canada. CMAJ 2018;190:E869-70

Gaffney A, Lexchin J, US, Canadian Pharmaceutical Policy Reform Working Group. Healing an ailing pharmaceutical system: prescription for reform for United States and Canada. BMJ 2018;361:k1039.

Alves T, Mintzes B, Lexchin J. Medicines information and the regulation of the promotion of pharmaceuticals. Science and Engineering Ethics 2018:https://doi.org/10.1007/s11948-018-0041-5

Lexchin J. Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study. BMJ Open 2018;8:e020377

Banerjee A, James R, McGregor M, Lexchin J. Nursing home physicians discuss caring for elderly residents: an exploratory study. Canadian Journal on Aging 2018;37:133-144.

Lexchin J. Pharmaceutical company spending on research and development and promotion in Canada, 2013-2016: a cohort analysis. Journal of Pharmaceutical Policy and Practice 2018;11:5.

Reynolds E, Guénette L, Lexchin J, Cassels A, Wilkes MS, Durrieu G, Beaulieu M-D, Mintzes B. Reconciling a “pleasant exchange” with evidence of information bias: a three-country study on pharmaceutical sales visits in primary care. Health Policy 2018;122:25-255

Lexchin J, Kohler J, Gagnon M-A, Crombie J, Thacker P, Shnier A. Combating corruption in the pharmaceutical arena. Indian J Med Ethics. Published online on March 15, 2018. DOI:10.20529/IJME.2018.022

Lexchin J. The pharmaceutical industry in contemporary capitalism. Monthly Review 2018;69(10). (Adapted from: Lexchin J. The pharmaceutical industry in the context of contemporary capitalism. In: Waitzkin H ed. Health care under the knife: moving beyond capitalism for our health. New York: Monthly Review Press, 2018:83-98.)

Gorkinkel I, Lexchin J. We need to mandate drug cost transparency on electronic medical records. CMAJ 2017;189:E1541-2.

Gleeson D, Townsend B, Lopert R, Lexchin J, Moir H. Financial costs associated with monopolies on biologic medicines in Australia. Australian Health Review doi.org/10.1071/AH17031

Lexchin J. Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis. BMJ Open 2017;7:e018372.

Gleeson D, Lexchin J, Lopert R, Kilic B. The Trans Pacific Partnership Agreement, intellectual property and medicines: differential outcomes for developed and developing countries. Global Social Policy 2017;1-21.

Lexchin J. The relationship between promotional spending on drugs and their therapeutic gain: a cohort analysis. CMAJ Open 2017;5:E724-728

Shnier A, Lexchin J. Continuing medical education and pharmaceutical industry involvement: an evaluation of policies adopted by Canadian professional medical associations. International Journal of Risk and Safety in Medicine 2017;29:1-16.

Shaughnessy AF, Vaswani A, Andrews BK, Erlich DR, D’Amico F, Lexchin J, Cosgrove L. Developing a clinician friendly tool to identify useful clinical practice guidelines: G-TRUST. Annals of Family Medicine 2017;15:413-18.

Lexchin J. The pharmaceutical industry and the Canadian Government: Folie à Deux. Healthcare Policy 2017;13:10-16.

Habibi R, Lexchin J, Mintzes B, Holbrook A. Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately? British Journal of Clinical Pharmacology 2017;83:2549-2556.

Lexchin J. Market exclusivity time for top selling originator drugs in Canada: a cohort study. Value in Health 2017;20:1139-1142.

Lexchin J. Myths and realities about why prescription drug prices in the United States are so high. Pharmaceutical Medicine 2017;31:143-148

Cosgrove L, Shaughnessy AF, Peters SM, Lexchin JR, Bursztajn H, Bero L. Conflicts of interest and the presence of methodologists on guideline development panels: a cross-sectional study of clinical practice guidelines for major depressive disorder. Psychotherapy and Psychosomatics 2017;86:168-170

Lexchin J. Publication of confirmatory studies required by Health Canada for drugs approved under a Notice of Compliance with conditions: a cohort study. CMAJ Open 2017;5:E295-E300

Lexchin J. Six myths about pharmacare. Health Law in Canada 2017;37(2&3):44-51

Lundh A, Lexchin J, Mintzes B, Schroll JB, Bero L. Industry sponsorship and research outcome. Cochrane Database of Systematic Reviews 2017, Issue 2. Art. No.: MR000033. Doi: 10.1002/14651858.MROOOO33.pub3.

Habibi R, Guénette L, Lexchin J, Reynolds E, Wiktorowicz M, Mintzes M. Regulating information or allowing deception? Pharmaceutical sales visits in Canada, France, and the United States. Journal of Law, Medicine & Ethics 2016;44:602-13.

Lexchin J. How safe and innovative are first-in-class drugs approved by Health Canada: a cohort study. Healthcare Policy 2016;12:65-75

Shaughnessy AF, Cosgrove L, Lexchin JR. The need to systematically evaluate clinical practice guidelines. Journal of the American Board of Family Medicine 2016;29:644-648

La Rochelle P, Lexchin J, Simonyan D. Analysis of the drugs withdrawn from the US market from 1976 to 2010 for safety reasons. Pharmaceutical Medicine 2016 DOI: 10.1007/s40290-016-0159-1

Shnier A, Lexchin J, Romero M, Brown K. Reporting of financial conflicts of interest in clinical practice guidelines: a case study analysis of guidelines from the Canadian Medical Association Infobase. BMC Health Services Research 2016;16:383.

Davis C, Lexchin J, Jefferson T, Gøtzsche P, McKee M. “Adaptive pathways” to drug authorization: adapting to industry? BMJ 2016;354:i4437.

Lexchin J, Gleeson D. The Trans Pacific Partnership Agreement and pharmaceutical regulation in Canada and Australia. International Journal of Health Services 2016;46:597-613.

Morgan SG, Gagnon M-A, Mintzes B, Lexchin J. A better prescription: advice for a national strategy on pharmaceutical policy in Canada. Healthcare Policy 2016;12(1):18-36.

Ronald LA, McGregor MJ, Harrington C, Pollock A, Lexchin J. Observational evidence of for-profit delivery and inferior nursing home care: when is there enough evidence for policy change? PLoS Medicine 2016;13:e1001995.

Mintzes B, Lexchin J, Santos Quintano A-L. Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect. British Medical Bulletin 2015;116:43-53.

Light DW, Lexchin J. The FDA’s new clothes. BMJ 2015;351:h4897.

Lexchin J. Formulary status of drugs in Ontario after Health Canada has issued a serious safety warning: a cohort study. International Journal of Risk & Safety in Medicine 2015;27:135-142.

Lexchin J, Ahmed T. Postmarket safety of drugs approved by Health Canada on the basis of clinical and surrogate outcomes: a cohort study. CMAJ Open 2015;3:E286-E291.

Hohl CM, Wickham ME, Sobolev B, Perry JJ, Sivilotti MLA, Garrison S, Lang E, Brasher P, Doyle-Waters MM, Brar B, Rowe BH, Lexchin J, Holland R. The effect of early in-hospital medication review on health outcomes: a systematic review. British Journal of Clinical Pharmacology 2015;80:51-61.

Lexchin J. Health Canada’s use of its priority review process for new drugs: a cohort study. BMJ Open 2015;5:e006816 (Correction: BMJ Open 2015;5:9e006816corr1).

Hohl C, Lexchin JR, Balka E. Can reporting of adverse drug reactions create safer systems while improving health data? CMAJ 2015;187:789-90

Light DW, Lexchin J. Why do cancer drugs get such an easy ride? BMJ 2015;350:h2068.

Lexchin J. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy. British Journal of Clinical Pharmacology 2015;79:847-859.

Chiu Y, Bero L, Hessol NA, Lexchin J, Harrington C. A literature review of clinical outcomes associated with antipsychotic medication use in North American nursing home residents. Health Policy 2015;119:802-813.

Lexchin J. Why are there deadly medicines? BMC Medicine 2015;13:27.

Lexchin J, Mintzes B. A compromise too far: a review of Canadian cases of direct-to consumer advertising regulation. International Journal of Risk & Safety in Medicine 2014;26:213-225.

Cosgrove L, Shaughnessy AF, Wheeler EE, Krimsky S, Peters SM, Freeman-Coppadge DJ, Lexchin JR. From caveat emptor to caveat venditor: time to stop the influence of money on practice guideline development. Journal of Evaluation in Clinical Practice 2014;20:809-812.

Lexchin J, Gagnon M-A. CETA and pharmaceuticals: impact of the trade agreement between Europe and Canada on the costs of prescription drugs. Globalization and Health 2014;10:30.

Habibi R, Lexchin J. Quality and quantity of information in Summary Basis of Decision documents issued by Health Canada. PLoS One 2014;9(3):e92038.

Herder M, Gibson E, Graham J, Lexchin J, Mintzes B. Regulating prescription drugs for patient safety: does Bill C-17 go far enough? CMAJ 2014; 186:E287-E292.

Lexchin J. Postmarket safety in Canada: are significant therapeutic advances and biologics less safe than other drugs? A cohort study. BMJ Open 2014;4:e004289.

Articles

Lexchin J. Health Canada committees swimming in financial conflicts of interest. The Conversation. May 20. Available at: https://theconversation.com/health-canada-committees-swimming-in-financial-conflicts-of-interest-116490

Lexchin J. Federal budget: a Canadian Drug Agency and rare disease funding are not enough. The Conversation. March 21. Available at: https://theconversation.com/federal-budget-a-canadian-drug-agency-and-rare-disease-funding-are-not-enough-113976

Honours and Awards

2019                            Clinician investigator, Toronto General Hospital Research Institute

2018                            Best editorial published in lay press, Emergency Department, University Health Network

2018                            Ethel Meade Award in research excellence from Ontario Health Coalition

2018                            Member College of Reviewers, CIHR

2017                            Olivieri lectureship on medical ethics, Harry Crowe Foundation, Toronto

2017                            Senior researcher award, Emergency Department, University Health Network

2015                            Senior researcher award, Emergency Department, University Health Network

2016                            Nominated for 2016 DFCM Outstanding Peer-Reviewed Publication Award

2014                            Nominated for Barer-Flood Prize for Health Services and Policy Research 2014

2013                            Nominated for York University President’s Research Excellence Award

Grants

2019: A Documentary Mini-Series Examining Pharmaceutical Policy. SSHRC $48,000 (1 year), PI: Joel Lexchin, Co-investigator: Sergio Sismondo. Application no.: 611-2018-0635

2018: Beyond transparency in pharmaceutical research and regulation. CIHR $489,600 (4 years), PI: Matthew Herder, Janice Graham, Trudo Lemmens, Joel Lexchin; Co-investigators: K Fierlbeck, D Juurlink, N Persaud, B Williams-Jones. Application no.: 389116.

2017: What works best to protect public health? An international comparison of post-market regulatory risk communication on prescription drugs. CIHR $1,158,976 (4 years). PI: Colin Dormuth, Barbara Mintzes, Ingrid Sketris. Co-applicants: Lisa Bero, Courtney Davis, Marie Louise De Bruin, Aaron Kesselheim, Joel Lexchin, Derelie Mangin, Thomas Moore, Lorri Puil, Elizabeth Roughead, Mary Wiktorowicz. Application no.: 378588

2017: How best to protect public health: a comparative analysis of regulatory safety warnings on medicines in Australia, Canada the European Union and the United States. NHMRC $1,002,283.40 (AUS) (3 years), CI: Barbara Mintzes, Elizabeth Roughead, Joel Lexchin, Lisa Bero, Colin Dormuth, Aaron Kesselheim, Wendy Lipworth, Marie De Bruin, Danijela Gnjidic, Lorri Puil; Association Investigators: Ameet Sarpatwari, Aukje Mantel-Teeuwisse, Elin Lehnbom, Ingrid Sketris, John Abraham, Neville Board, Priya Bahri, Richard Day, Sallie-Anne Pearson, Thomas Moore. Application no.: APP1122332

2013-2016: Adverse drug event reporting in PharmaNet to improve patient safety and inform policy. CIHR $600,000.

2012-2014: Assessing the ethics of the dominant business model in the Canadian pharmaceutical sector; tackling institutional corruption through regulatory reforms. CIHR $84,204.

2012-2013: Planning the evaluation of medication review in emergency department patients. CIHR $24,997.

2012-2014: Pharmaceutical Sales Representatives and Patient Safety: exploration of physician experiences in three countries and implication for regulatory policy. CIHR $154,183.

2010-2017: Re-imagining long-term residential care: an international study of promising practices. Social Sciences and Humanities Research Council (SSHRC): Major Collaborative Research Initiatives $2,498,000

Courses