The Health Law, Ethics & Policy Seminar Series
presents
Joel Lexchin
Professor, School of Health Policy and Management, York University
“Those Who Have the Gold Make the Evidence: The Pharmaceutical Industry and Clinical Trials”
Thursday, October 13, 2011
12:30 – 2:00 p.m.
Faculty of Law, University of Toronto
84 Queen's Park, Falconer Hall, Solarium (FA2)
Toronto, Ontario, M5S 2C5
Map
Co-sponsored by the Centre for Innovation Law & Policy
Everyone is welcome to attend, no registration is required.
ABSTRACT
Pharmaceutical companies fund the bulk of clinical research that is carried out on medications. Poor outcomes from these studies can have negative effects on sales of medicines. Previous research has shown that company funded research is much more likely to yield positive outcomes than research with any other sponsorship. This talk will discuss the possible ways in which bias can be introduced into research outcomes by drawing on concrete examples from the published literature. Poorer methodology in industry-funded research is not likely to account for the biases seen. Biases are introduced through a variety of measures including the choice of comparator agents, multiple publication of positive trials and non-publication of negative trials, reinterpreting data submitted to regulatory agencies, discordance between results and conclusions, conflict-of-interest leading to more positive conclusions, ghostwriting and the use of “seeding” trials. Thus far, efforts to contain bias have largely focused on more stringent rules regarding conflict-of-interest (COI) and clinical trial registries. There is no evidence that any measures that have been taken so far have stopped the biasing of clinical research and it’s not clear that they have even slowed down the process. Economic theory predicts that firms will try to bias the evidence base wherever its benefits exceed its costs. The examples given here confirm what theory predicts. What will be needed to curb and ultimately stop the bias that we have seen is a paradigm change in the way that we treat the relationship between pharmaceutical companies and the conduct and reporting of clinical trials.
BIOGRAPHY
Joel Lexchin received his MD from the University of Toronto in 1977 and for the past 24 years has been an emergency physician at the University Health Network. He is currently a Professor in the School of Health Policy and Management at York University. He has been a consultant on pharmaceutical issues for the province of Ontario, various arms of the Canadian federal government, the World Health Organization, the government of New Zealand and the Australian National Prescribing Service. He is the author or co-author of over 100 peer-reviewed articles on topics such as physician prescribing behaviour, pharmaceutical patent issues, the drug approval process and prescription drug promotion.
A light lunch will be served.
For other upcoming seminars, see the schedule online or contact m.casco@utoronto.ca.
The Health Law Ethics and Policy Workshop series brings local, national, international scholars and policy makers as guest speakers to the Faculty of Law, University of Toronto to stimulate discussion of issues related to the intersection of law with health care and related ethical and social issues. The series is organized by the Faculty’s Health Law group and is sponsored by the CIHR Training Program in Health Law, Ethics and Policy. The training program addresses the global shortage of experts in the multidisciplinary field of health law, ethics and policy by providing key learning opportunities and competitive scholarships to outstanding Canadian and international graduate students. For more information about the seminar series and/or the training program, please visit our website at: www.healthlawtraining.ca.
