Dr. Stuart MacLeod, FCAHS, is Professor of Pediatrics in the Faculty of Medicine at the University of British Columbia and former Vice-President Research Coordination and Academic Liaison for the Provincial Health Services Authority of British Columbia.
Dr. MacLeod has had the opportunity to contribute to the assessment process from both a planning and participatory perspective. Currently, he is the Chair of the Expert Panel on the State of Therapeutic Products for Children, an ongoing assessment at the Council of Canadian Academies. His work with the Canadian Academy of Health Sciences has also given him insight into the process of evaluating assessment questions and contributing to panel planning.
Dr. MacLeod describes why he values his involvement with the CCA, and he reflects on the impact that his work in Canada and internationally brings to bear on his contribution to the assessment process.
Q: The CCA is honoured to have you as the Chair of the Expert Panel on Therapeutics for Children. Can you tell us about what drew you to the role and to working with the CCA?
A: As a fellow of the Canadian Academy of Health Sciences, I have been aware of the Council’s important role in support of policy decisions for some time. Since the 1970s, most of my professional and research activities have been devoted to child health and, for much of the time, I have been an advisor to Health Canada, the Canadian Paediatric Society and the Canadian Association of Paediatric Health Centres on questions regarding evaluation of drug therapy for children. I have long believed the therapeutic needs of children in Canada have been poorly served by our regulatory system. In the wake of enormous progress made in the United States and Europe in the last 15 years, it is time for Canada to be more attentive to pressure for more effective and safer drug therapy for the youngest 20 per cent of the population. It is very encouraging that Health Canada, in requesting a Council assessment, has acknowledged the need to evolve in this critical domain.
Q: You have had a very impressive career in pediatric clinical pharmacology and toxicology. How did this become your area of focus? Are there a couple of career highlights you could share?
A: After graduating from medical school, I trained in adult internal medicine. However, I became interested in the biotransformation of therapeutic drugs, and completed a PhD at McGill University examining the development of these mechanisms in newborns. That expertise eventually led to an appointment at The Hospital for Sick Children (HSC). From that platform and with generous support from HSC, I was able to develop a comprehensive program in pediatric pharmacology and toxicology. The program that we started in the 1980s continues to be a world leader in research and training.
From HSC, I moved to McMaster University as the Dean of the Faculty of Health Sciences. In my 15 years at McMaster, I was a professor in the Department of Clinical Epidemiology and Biostatistics and a participant in a revolutionary demand for better research evidence in support of medical decision-making.
I became involved with child health in East Africa beginning at HSC and continuing through McMaster’s engagement with the International Clinical Epidemiology Network (funded by the Rockefeller Foundation). The opportunity over the past 25 years to work with international agencies such as the World Health Organization in pursuit of better drug therapy for children in low-income countries has been a highlight of my career.
Q: What do you see as some of the future questions and challenges associated with ensuring drug safety for children that Canada needs to address?
A: Canada will need to update its regulatory framework for therapeutic products in order to ensure that new treatments are consistently studied in the populations that will receive them, beginning with infants and progressing through adolescents. As part of the renewal process, appropriate use of Canada’s research capacity must be made in addressing the challenges of developmental disorders and rare genetically determined conditions that commonly present in childhood.
In order to meet pediatric needs for safe and effective therapy, it will be essential for Canada to facilitate the integration of research capacities that exist in different parts of the country, to capitalize on its leading expertise in pharmaceutical, evaluative and implementation sciences, and to build effective collaborative research networks.
Q: As Chair of the Expert Panel that has just started its work, what do you believe is the value of evidence-based assessments? Do you have any reflections on the process thus far?
A: The future of optimally safe and effective therapy for those under age 18 rests with our ability through research to create a solid and comprehensive evidence base to guide clinical decision-making. It also depends on the development of our ability to translate sound scientific knowledge into better practice. Canada is fortunate to have considerable science capacity in this area, and the main challenge for the Panel will be to channel evidence into implementation that will produce better health outcomes in the child health arena.
The first panel meeting demonstrated a high degree of agreement on how best to inform Health Canada so that it can better address the needs of those under age 18. A dialogue with Health Canada officials reconfirmed the importance of the questions asked, and convinced panel members that the Council’s assessment of the child health science-base in therapeutics will be well received. Finally, I would note that the Panel is fortunate to have outstanding input from individuals who have worked not only in North America and Europe but also in Asia and Africa — providing a truly international perspective.