Industry partnerships in transplantation: How should AJT manage the inevitable conflict of interest?

To the Editor: The role of industry has been substantive in many fields of medicine. In transplantation, industry investment is crucial for advancing effective immunosuppression and for knowledge translation in research and daily practice. However, with industry relationships come real and perceived conflicts of interests (COIs), not only for physicians and researchers, but also for professional societies, and peer-reviewed journals. Individual physicians acting as editors in medical journals may have received substantive industry payments.1Liu JL Bell CM Matelski JJ et al.Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study.BMJ. 2017; 359: j4619Crossref PubMed Scopus (72) Google Scholar Medical journals, including those sponsored by professional societies, receive significant income from advertisement and reprint orders.2Handel AE Patel SV Pakpoor J et al.High reprint orders in medical journals and pharmaceutical industry funding: case-control study.BMJ. 2012; 344 (e4212.)Crossref PubMed Scopus (33) Google Scholar Landmark studies are driven by commercial interests and many academic researchers are personally involved in the commercialization of their research. Simultaneously, many institutions struggle with sustaining conventional funding sources and are encouraged to commercialize their research outputs. For example, commercialized minimal-invasive diagnostic assays are potentially offered as direct to consumer testing, introducing commercial interests between physicians and patients. Although financial support from industry is today more transparent and better regulated, the conflict between funding needs and the potential bias introduced by commercial interests continues to exist and likely increases. Hence the question arises: Do we need to advance from mere disclosure of COIs, to more comprehensive COI management? What is the role of American Journal of Transplantation in this process? Medical journals provide a platform for distributing knowledge, and request more or less voluntary disclosure of potential COI and funding sources. However, even clear existing financial COI has not been adequately reported among many authors of diabetes, hyperlipidemia, or cardiology guidelines,3Neuman J Korenstein D Ross JS et al.Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study.BMJ. 2011; 343: d5621Crossref PubMed Scopus (190) Google Scholar,4Alhamoud HA Dudum BA Young HA et al.Author self-disclosure compared with pharmaceutical company reporting of physician payments.Am J Med. 2016; 129: 59-63Abstract Full Text Full Text PDF PubMed Scopus (24) Google Scholar and similar gaps may exist in our field. Voluntary disclosure of COI leaves uncertainty with the disclosing party to select what to disclose, and with the reader to judge the potential impact of the disclosure on the relevance and interpretation of the published data. Already now, journals take action to uncover plagiarism, unethical research design, or statistical manipulations, all crucial efforts to verify results and assure their reproducibility and unbiased presentation. Should not targeted management of COI be part of this due diligence during the peer review process? Major non-profit organizations, academic institutions, and companies have established COI management policies for reporting and management of perceived and real COIs. Special software designed for this purpose help to structure the reporting of COIs and auto flag relevant conflicts. Recently, guidelines for COI management among authors of clinical guidelines have been published.5Qaseem A Wilt TJ Clinical Guidelines Committee of the American College of PhysiciansDisclosure of Interests and Management of Conflicts of Interest in Clinical Guidelines and Guidance Statements: methods from the Clinical Guidelines Committee of the American College of Physicians.Ann Intern Med. 2019; 171: 354-361Crossref PubMed Scopus (33) Google Scholar During peer review, COIs could be reported to a database, and a specialized COI editor could screen both financial and intellectual potential COIs, and flag them as low, moderate, or high-level, with regard to potentially biasing the conclusions from a manuscript. A dedicated team at the Editorial Board would then decide on how to proceed with high-level COIs. For example, the decision could be to report the COI more visibly including the specific concerns identified by the COI manager. Also a disclaimer or targeted Editorial could be added, or even preventing the publication of a manuscript could be considered. Some journals (Lancet, New England Journal of Medicine) already have policies to not accept editorials or review articles if significant financial competing interests exist for the authors. The field of transplantation needs commercial partnerships, which must be of mutual benefit with the common goal of advancing the field for our patients. All partnerships must be transparent, with peer-reviewed journals and professional societies assuming a lead role in assuring that COIs are reported, and appropriately managed. We thank and acknowledge Dr. Mark Stegall and Dr. Christopher Blosser for critically reviewing this letter and providing most helpful guidance in preparing the letter. The authors of this manuscript have conflicts of interest to disclose as described by the American Journal of Transplantation. Ilkka Helanterä is receiving consultancy honoraria from Aplagon, Astellas, Novartis, and Hansa Biopharma, and is enrolled in the 2020/2021 Editorial fellowship program with the American Journal of Transplantation. Roslyn Mannon has grant support relationships with Mallinckrodt, CSL Behring, Transplant Genomics and received honoraria from CSL Behring, serves as Steering Committee Member for IMAGINE Study (Vitaeris/CSL Behring) and as Deputy Editor for the American Journal of Transplantation. Michael Mengel holds research funds from Roche diagnostics and Astra Zeneca, is receiving consultancy honoraria from Novartis and Vitaeris (now CSL Behring), and serves as Associate Editor for the American Journal of Transplantation. The opinions here represent our own, and do not express the views or policies of the American Journal of Transplantation or its affiliated professional societies.

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