A recent international study led by researchers from McGill University and the McGill University Health Centre (MUHC) examines the complex and controversial interplay of conflicts of interest between physician experts, medicine and the pharmaceutical or medical device industry. The results of the analysis, which are published in the Annals of Internal Medicine, aim to advance the management of conflicts of interest in medical guidelines.
Over the last decade governments, medical specialty societies and academia have increasingly confronted an ethical dilemma in the development of influential, independent, expert medical guidelines, says lead author, Derek J. Jones, a member of McGill University’s Faculty of Law Research Group on Health and the Law.
According to the study, clinical practice guidelines (CPGs) on heart conditions, mental disorders, flu and diabetes have been criticized, questioned or annulled because of Conflicts of Interest (COIs) issues in the US, Canada, France and World Health Organization. Should physician experts who have, or had, financial relations with industry be included, excluded, or limited from the development of international clinical practice guidelines, Jones asks. What if their expertise is rare, unique or essential?
The interdisciplinary project developed and analyzed the impact of an ethics framework designed to manage COIs in an international CPG on gastroenterology. They found the initiative fruitful, if challenging. Given the absence of uniform COI definitions, procedures or standards in the international arena, we found that an ethics framework helps to identify COIs, ethics issues, and COI management options in the process, explains Jones.
“We further sought to measure the impact of COIs on voting and discussing the CPG recommendations, explained Dr. Alan Barkun, corresponding author of the study and chief of gastroenterology at the MUHC and professor of medicine at McGill. Our analysis of the COI management tool used revealed little impact on voting recommendations for the guideline and some impact on discussion. These important issues demand further analysis and initiatives.
The study thus recommends targeted research, the use of ethics frameworks, a financing model, and international and institutional policy initiatives to better manage conflicts of interest in the development of future CPGs.
About this study:
The study “Conflicts of Interest Ethics: Silencing Expertise in the Development of International Clinical Practice Guidelines” was coauthored by Derek J. Jones, JD; Alan N. Barkun, MDCM, MSc (Clinical Epidemiology); Yidan Lu, MDCM; Robert Enns, MD; Paul Sinclair, MSc; Myriam Martel, BSc; Ian Gralnek, MD; Marc Bardou, MD, PhD; Ernst J. Kuipers, MD; and Joseph Sung, MD, PhD, for the International Consensus Upper Gastrointestinal Bleeding Conference Group
This work was supported by funds from the Canadian Association of Gastroenterology; European Association for Gastroenterology and Endoscopy; Asian Pacific Society of Digestive Endoscopy; and Canadian Institutes of Health Research Institute of Diabetes, Metabolism and Nutrition and arms-length contributions from AstraZeneca Mölndal (Sweden), Abbott Canada, and Olympus Canada. The Canadian Association of Gastroenterology also provided in-kind support and administered the meeting.
- Cited study: http://annals.org/article.aspx?volume=156&page=809
- McGill University Health Centre (MUHC): www.muhc.ca
- Research Institute of the MUHC (RI MUHC): www.muhc.ca/research/dashboard
- McGill University: www.mcgill.ca