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Assessing transfer of value from industry to physicians: the importance of studying and reporting the appropriate population

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We read with interest a recent study analysing industry payments to pathologists in the USA. In this study, Murayama and Hirota analysed general and research payments made to pathologists in… Click to show full abstract

We read with interest a recent study analysing industry payments to pathologists in the USA. In this study, Murayama and Hirota analysed general and research payments made to pathologists in the USA from 2013 to 2021 using the Open Payments database. The results reported by the authors may have significant implications for physician–industry relationships, biomedical researchers and the overall healthcare system in the USA. Therefore, we believe it is important to consider several limitations not addressed by the authors in their study. The Open Payments database was established by the Physician Payments Sunshine Act (42 U.S.C. § 1320a−7b), which requires manufacturers of drugs, medical devices, biologics, and medical supplies and group purchasing organisations (GPOs) to report to the US Centers for Medicare and Medicaid Services (CMS) payments made and investment interests given to physicians and teaching hospitals. This law requires physicians, teaching hospitals and GPOs to acknowledge any financial or investment relationships. Manufacturers and GPOs must report any ownership or investment benefits in those companies held by physicians or their immediate family members. The CMS Open Payments database has previously been used to query industry payments to physicians, including in the field of pathology. As the authors noted, nonUS physicians are exempted from the CMS Open Payments database; however, it is important to highlight that there are numerous individuals that hold nonmedical doctorates that practice in the field of pathology in the USA who could in theory receive payments, but would otherwise not be included in the database. This issue, which is inherent to the CMS Open Payments database, represents a significant limitation when considering the ‘denominator’ of the population being studied. The authors report they used the National Plan and Provider Enumeration System (NPPES) database to identify pathologists. The authors indicate that their crosssectional study identified 21 664 pathologists; however, according to the latest data from the Association of American Medical Colleges (AAMC), there are 12 171 active pathologists as of 2021. The authors do highlight a study illustrating potential reasons for the discrepancy in differences between the number of pathologists as reported by the NPPES and AAMC databases. Interestingly, a search for ‘Allopathic & Osteopathic Physicians—Anatomic and Clinical Pathology‘ in the Open Payments database results with 7616 individuals; if all other pathology subspecialties are included, the total is 19 198. However, these data are not unique, as individuals can be listed under Allopathic and Osteopathic Physicians—Anatomic and Clinical Pathology as well as subspecialty search. Furthermore, the American Board of Medical Specialties (ABMS) indicates there are 31 795 board certified pathologists, a number that is different from both the AAMC data and what the authors used. Moreover, we believe it is also important to consider the denominator in terms of the ‘true’ population likely to develop industry relationships—academic pathologists. As these individuals are more likely to be involved in research and clinical trials, they will have more incentive to collaborate with drug/device manufacturers. Thus, the median payment per pathologists that are likely to receive payment is in all probability, much higher. An additional point regarding the characteristics of the population studied that should be addressed relates to the demographic terminology used by the authors. The authors report they collected the gender of the pathologists in their study. While we acknowledge the NPPES database is flawed with respect to sex/gender terminology, the authors conflate the terms gender and sex, despite guidelines and mandated reporting methodology published by various organisations, including the US National Institutes of Health, the American Medical Association and even by the journal publisher itself. The importance of appropriate and proper reporting methodology has even been published in the context of pathology. Regarding the data analysed in the study, the authors reportedly collected ‘all general and research payments’, but excluded associated research payments that overlapped with direct research payments. Yet, the authors do not discuss how they determined overlapping payments, nor do they provide information on how much this monetary value might be. Likewise, the authors do not indicate if they included the CMS Open Payments category of ‘Ownership or Investment Interest’. While Ownership and Investment Interest comprises just 1.9% (US$1.26 billion) of the transference of value for the whole CMS Open Payments database, pathologists are indeed included in the 2021 group. Alas, the authors missed an opportunity to present a more complete picture of transference of value using CMS Open Payments dataset. Finally, the authors report the median payment for eligible pathologists was US$4140 (direct research), US$146 (nonresearch) and US$70 926 (associated research payments) over the study duration. This stands in stark contrast to the reported modest payment of US$78 for all pathologists. Furthermore, the Open Payments database reports the ‘specialty mean’, which for pathology is given on a yearly basis. Thus, the original data show the specialty mean is higher than the average US physician in the CMS database (eg, pathologists are receiving more money in many years) (table 1). Conversely, when comparing the CMS Open Payment median payments by specialty to the US median physician general payment per year, pathology physicians accepted a higher transference of value for general payments in 2020, but not in 2021, 2019, 2018, 2017, 2016 and 2015. Thus, regardless of how one analyses the data, pathologists in the CMS Open Payments do on occasion receive more general payment transference of value than all other medical fields. Couple this with the fact that pathology as a field comprises 1%–2% of all US physicians, and that sends a powerful message, one that is lost in the Discussion section in this study. In conclusion, we commend the authors for highlighting an important issue in healthcare and advancing the discourse regarding physician–industry relationships. Understanding the extent of these relationships can impact potential conflictsofinterest, drug and device approvals, publishing of biomedical research and patient trust in the overall medical establishment. For these reasons, it is crucial that great care be taken to ensure one is studying and reporting the appropriate population and the populations’ characteristics. Letter

Keywords: cms open; pathology; industry; open payments; payments database

Journal Title: Journal of Clinical Pathology
Year Published: 2023

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