TY - JOUR
T1 - SAGES perspective
T2 - professional medical associations, commercial interests, and conflicts of interest
AU - Shadduck, Phillip
AU - Sylla, Patricia
AU - Schwarz, Erin
AU - Reinke, Caroline
AU - Denk, Peter
AU - Ginsberg, Shelley
AU - Asbun, Horacio
AU - Pryor, Aurora
N1 - Funding Information:
Meaningful innovation and progress in gastrointestinal surgery requires collaboration with industry. Surgeon input is indispensable throughout the entire device development process—defining unmet need, prototyping and refining devices, preclinical and clinical testing, and surgeon training. If PMAs were to receive zero financial support from industry, that would necessitate difficult trade-offs, including exclusion of important initiatives, educational and training opportunities that SAGES believes would compromise innovation, education, and patient care. SAGES believes that with appropriate COI disclosure and mitigation processes, PMAs can provide educational activities that are both scientifically and ethically sound, despite financial support from industry. Doing so requires ownership by PMA leadership and a commitment to tough processes. SAGES has developed and implemented uniquely comprehensive and stringent processes for the organization, the Executive Committee, the annual meeting, the development of Guidelines, and other activities. The SAGES COI processes have been effective, with implementation reducing perceived bias at the annual meeting to less than 1%. Despite these efforts, SAGES was recently deemed by the ACCME to be in non-compliance with ACCME standards related to faculty with ownership interest in relevant commercial interests. This review of the SAGES COI disclosure and mitigation experience (2009–2021) highlights several remaining challenges—validating complete physician disclosure and interpreting apparent disclosure discrepancies, addressing physician employees/owners, and accurately establishing relevance of financial relationships to the content of accredited educational activities. SAGES will continue to work closely with the ACCME to refine its COI processes and to provide the highest quality educational content to its members. Acknowledgements
Funding Information:
The authors gratefully acknowledge Prashant Sinha, Alex Lois, Brendan Marr, Matt B. Martin, Grace Montenegro, Dang-Tuan Pham, Jenny Shao, Ketan Sheth, Arianne Train, and Yulia Zak (SAGES COI Committee); Liane Feldman, Jeff Marks, John Mellinger, and Christopher Schlachta (SAGES Executive Committee); and Sallie Matthews (SAGES Executive Director).
Funding Information:
In a 2009 JAMA Special Communication by Rothman and colleagues titled “Professional Medical Associations and Their Relationships with Industry: A Proposal for Controlling Conflict of Interest” [], the authors recognized the need for collaboration between PMAs and the medical device/pharmaceutical industry for development, innovation, and education. They also argued strongly for PMAs to become financially independent and to achieve a goal of no financial support from industry, excluding exhibit hall fees and advertising in journals, stating: “Because many PMAs receive extensive funding from pharmaceutical and device companies, it is crucial that their guidelines manage both real and perceived conflict of interests. Any threat to the integrity of PMAs must be thoroughly and effectively resolved.” Since complete financial independence from industry support may be difficult if not impossible to achieve, they proposed ten specific recommendations (including a mechanism to declare and manage potential COI) to maintain the authority, standing, and autonomy of PMAs and the medical community at large. Critics of their proposals argue that regulations aimed at limiting all aspects of PMA/physician-industry relationships would have unintended adverse consequences with respect to the delivery of educational and training opportunities. Acknowledging the concerns of potential bias introduced by financial relationships with commercial interests, many PMAs, including SAGES, developed internal policies to disclose and manage COI and industry relations, and to promote transparency.
Publisher Copyright:
© 2023, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2023/4
Y1 - 2023/4
N2 - Background: Professional medical associations (PMAs) have an essential role in advancing medical care and health. PMAs promote skills training, clinical standards, and other important educational activities. Most often, PMAs are not-for-profit entities that rely upon funding from industry to help cover the costs of these valuable activities. Equally important, innovation and progress in surgery require physician collaboration with industry throughout the product development process. SAGES has opined that, with appropriate Conflict of Interest (COI) disclosure and management processes, PMA educational activities can be both scientifically and ethically sound. Methods: SAGES has developed and implemented comprehensive and stringent processes for managing potential COI within the organization, at the annual meeting, and in developing educational offerings. This document reviews the SAGES COI processes and results 2009–2021. Results: Implementation of the SAGES COI disclosure and management processes reduced the reported perceived incidence of bias at the annual meeting from 4.4–6.2% (2008–2010) to 1.2–2.2% (2011–2013). Recent comparison of reported disclosures revealed a rise in number of speakers with financial relationships and an increase in reporting of disclosures in presentations without an associated increase in need for conflict resolution by the COI committee. Despite good overall adherence to COI policies, SAGES was recently cited for non-compliance with ACCME standards related to inclusion of faculty with ownership interest. This experience highlighted the potential for discordance in the interpretation of whether disclosures relate to specific CME content. SAGES COI processes have since been updated to reflect the more stringent 2020 ACCME Standards that exclude speakers and planners with ownership interest from any CME activity. Conclusions: The SAGES experience with disclosure and mitigation of financial relationships highlights the challenges of validating the accuracy of physician disclosures and establishing the relevance of financial relationships to the content of accredited educational activities. SAGES will continue to streamline its COI disclosure process with specific focus on aligning all financial disclosures among the various reporting platforms.
AB - Background: Professional medical associations (PMAs) have an essential role in advancing medical care and health. PMAs promote skills training, clinical standards, and other important educational activities. Most often, PMAs are not-for-profit entities that rely upon funding from industry to help cover the costs of these valuable activities. Equally important, innovation and progress in surgery require physician collaboration with industry throughout the product development process. SAGES has opined that, with appropriate Conflict of Interest (COI) disclosure and management processes, PMA educational activities can be both scientifically and ethically sound. Methods: SAGES has developed and implemented comprehensive and stringent processes for managing potential COI within the organization, at the annual meeting, and in developing educational offerings. This document reviews the SAGES COI processes and results 2009–2021. Results: Implementation of the SAGES COI disclosure and management processes reduced the reported perceived incidence of bias at the annual meeting from 4.4–6.2% (2008–2010) to 1.2–2.2% (2011–2013). Recent comparison of reported disclosures revealed a rise in number of speakers with financial relationships and an increase in reporting of disclosures in presentations without an associated increase in need for conflict resolution by the COI committee. Despite good overall adherence to COI policies, SAGES was recently cited for non-compliance with ACCME standards related to inclusion of faculty with ownership interest. This experience highlighted the potential for discordance in the interpretation of whether disclosures relate to specific CME content. SAGES COI processes have since been updated to reflect the more stringent 2020 ACCME Standards that exclude speakers and planners with ownership interest from any CME activity. Conclusions: The SAGES experience with disclosure and mitigation of financial relationships highlights the challenges of validating the accuracy of physician disclosures and establishing the relevance of financial relationships to the content of accredited educational activities. SAGES will continue to streamline its COI disclosure process with specific focus on aligning all financial disclosures among the various reporting platforms.
KW - Bias
KW - Conflict of interest
KW - Disclosure
KW - Ethics
KW - Open payments
KW - Professional medical association
UR - http://www.scopus.com/inward/record.url?scp=85149994507&partnerID=8YFLogxK
U2 - 10.1007/s00464-023-09897-9
DO - 10.1007/s00464-023-09897-9
M3 - Article
AN - SCOPUS:85149994507
SN - 0930-2794
VL - 37
SP - 2517
EP - 2527
JO - Surgical Endoscopy and Other Interventional Techniques
JF - Surgical Endoscopy and Other Interventional Techniques
IS - 4
ER -