Research Payments Research Articles

Research and Nonresearch Industry Payments for COVID-19 mRNA Vaccines in the United States.

Research and Nonresearch Industry Payments for COVID-19 mRNA Vaccines in the United States.

Financial conflicts of interest of OncoAlert: An informal oncology professional network

ImportanceSocial media platforms have allowed the formation of informal professional healthcare networks. Transparency in funding, membership requirements, financial conflicts of interest (FCOI), and messaging are necessary to ensure best practices for similar networks in the future. ObjectiveTo analyze the FCOIs of US-based physician members of the OncoAlert Network and appraise the content of their public Twitter account. Design, setting, participantsThis cross-sectional study assessed the FCOIs among US-based physician members of the OncoAlert Network between 2015 and 2020. FCOI data were obtained through the Open Payments Database. Additionally, tweets were examined for content analysis. Main outcomes and measuresThe number of US-based physician members with FCOIs with the pharmaceutical industry; the amount of general, research, and associated research payments; and the perceived attitude of tweet content from the OncoAlert Network Twitter account. ResultsOf 34 US physician members of the OncoAlert Network, 31 (91.2%) received general payments from pharmaceutical companies according to the Open Payments Database. Between 2015 and 2020, US physician members of the OncoAlert Network received a median of $83,600 in general payments (interquartile range [IRQ], $7,200-$221,500). Fourteen members (41.1%) received more than $100,000 in general payments. Additionally, 480 (15.7 %) of 3064 tweets retrieved from the OncoAlert Twitter account mentioned a drug or clinical trial. Of these, 31.6 % (n = 152) had a positive disposition and 3.3 % (n = 16) were negative or critical. Conclusions and relevanceOver 90% of US physician members of the OncoAlert Network had FCOIs between 2015 and 2020. Despite the network’s non-profit status, FCOIs amongst its members may influence content produced on the network’s social media platforms, such as Twitter, where content discussing drugs and clinical trials are often positive and seldom negative or critical. For future informal professional networks, further research is required to establish best practices for issues such as membership requirements, funding, and FCOI disclosure.

The relationship between academic influence, NIH funding, and industry payments among academic shoulder and elbow surgeons.

The effect of academic influence, or the volume and quality of a surgeon's publications, on industry payments and National Institutes of Health (NIH) funding has recently been studied in some academic orthopedic subspecialities. The purpose of this study is to evaluate the relationship between academic influence, industry payments, and NIH funding among American Shoulder and Elbow Surgeons accredited shoulder and elbow fellowship faculty. Shoulder and elbow fellowships and affiliated faculty members were identified from the American Shoulder and Elbow Surgeons website. Academic influence, measured by the Hirsch (h)-index, and the number of articles published were determined for faculty members using the Scopus Database Author Identifier tool. Industry payments were derived from the Centers for Medicare and Medicaid Services Open Payments database. NIH funding was determined using the NIH's Research Portfolio Online Reporting tool. Statistical analysis used Spearman correlations and the Mann-Whitney U-test with an alpha value of 0.05 (P<.05). A total of 146 faculty members were included. Twenty-two percent (42 of 146) received nonresearch payments, whereas 78% (114 of 146) received industry research funding averaging $6364 (standard deviation=$21,213). NIH funding averaged $272,589 (standard deviation=$224,635), and 5% received NIH funding (7 of 146). Faculty members who received NIH funding had a higher average h-index than those who did not (38±22 vs. 22.64±22.7, P=.02), whereas those receiving industry research payments had a greater number of publications than those who did not (127.97±127.2 vs. 100.3±122.3, P=.03). Industry nonresearch payments did not impact the number of publications or the h-index. This study demonstrated that academic influence among academic shoulder and elbow surgeons is not greater in those who receive nonresearch industry funding. However, surgeons with industry research funding did produce more publications, whereas NIH funding is associated with greater academic influence.

Trends and Characteristics of Industry Payments for Ophthalmology Research From 2014 to 2020

Characterizing industry-ophthalmology collaborations in research can highlight current areas of focus, improve transparency, and identify potential sources for conflicts of interest. To assess the trends and characteristics in research payments reported from industry to ophthalmologists from 2014 to 2020. This cross-sectional study used data from the Centers of Medicare & Medicaid Services' Open Payments database (OPD), which contains public records of payments between industry and physicians, to identify all ophthalmologists who received industry payments for research purposes between 2014 and 2020. Industry funding was compared with public research funding by the National Eye Institute. The value and distribution of payments, sponsoring manufacturers, and research products were assessed. Changes in aggregate and per individual-level funding were characterized using formal trend analysis. From 2014 to 2020, 2102 ophthalmologists were reported to have received $825 417 233 in industry research payments. Industry funding increased 203% from $62 924 525 in 2014 to $190 714 508 in 2020 (P = .01). Comparatively, total National Eye Institute research funding during the same period was $5 003 407 764 and increased 6.6% from $701 313 262 in 2014 to $747 929 556 in 2020 (P = .04). The share of all medical research funding from industry directed specifically toward ophthalmology research increased from 1.2% in 2014 to 3.2% in 2020 (P = .04). The distribution of industry payments was skewed, with the top 15 of 108 manufacturers accounting for 93.9% of funding. The top 10% of ophthalmologists (210) were reported to have received 65.7% of all research dollars ($542 299 121). The highest funded research products were anti-vascular endothelial growth factor agents, glaucoma treatments, and intraocular lenses. Although unequal in distribution, industry-funded research in ophthalmology is extensive and increasing in scope. Industry funding for research is less than that of public funding; however, industry funding increased faster between 2014 and 2020. Results of this study highlight the increasing importance of industry funding in ophthalmology research, but it may also present ethical challenges for clinicians collaborating with industry.

Changes in Industry Marketing and Research Payments to US Physicians and Teaching Hospitals During the COVID-19 Pandemic

This cross-sectional study explores ways that the COVID-19 pandemic was associated with changes in research and marketing payments from pharmaceutical and medical device companies before and during the pandemic.

424.9: Real-World Treatment Patterns and Outcomes For Cytomegalovirus Infection and Disease in Hematopoietic Stem Cell Transplant Recipients in Selected Countries Outside of North America and Europe: A Systematic Review

Background: There is a paucity of real-world data on treatments used for cytomegalovirus (CMV) in hematopoietic stem cell transplant (HSCT) recipients, which differ across countries, outside of developed markets. To address this knowledge gap, a systematic review was conducted to evaluate current treatment patterns for CMV infection and disease following HSCT in selected countries outside of North America and Europe and describe related outcomes. Methods: Information sources (search period: 01 Jan. 2011 – 21 Jul. 2021) included indexed literature (Ovid® MEDLINE and Embase, Cochrane Database of Systematic Reviews and World Health Organization database Global Index Medicus), conference abstracts, pragmatic searches of the grey literature and snowballing of references lists of retained studies. Observational studies of interest included HSCT recipients (any age) who developed CMV infection or disease in 15 selected countries in Asia-Pacific, Latin America, Russia, and the Middle East. Outcomes of interest were treatment patterns for CMV infection and CMV disease, proportion of patients (pts) with resistant and refractory CMV including definitions, treatment-related outcomes and adverse events (AEs). The protocol was registered in PROSPERO (CRD42020205559). Results: Out of 25 retained studies (33 to 475 pts), most included allogeneic HSCT recipients (n=21, 84.0%) and adult pts (n=20, 80.0%). In HSCT recipients, pre-emptive therapy with intravenous ganciclovir (IV GCV) and/or valganciclovir (VGCV) is the conventional first-line (1L) approach for CMV infection prevention, with a median treatment duration of 14-24 days (5 studies). GCV IV was also the conventional treatment for CMV disease (5 studies), with treatment lasting 12-30 days (3 studies). Neutropenia was observed in 30.0% and 39.8% pts treated with GCV and, in 3 studies, neutropenia, myelosuppression, and nephrotoxicity led to GCV discontinuation, respectively, in 13.6%, 10.0%, and 2.3% of pts. In 3 studies, up to 10.0% of pts had second-line (2L) treatment with foscarnet, due to GCV-related myelosuppression. The reported proportion of pts with resistant CMV (definition not specified) ranged between 0% and 7.7% (5 studies; Figure 1). These pts received foscarnet or cidofovir as 2L therapy for a mean duration of 14 days (no data on AEs reported). In 3 studies, estimates of refractory CMV were 2.9%, 13.0%, and 49.4% (latter estimate reported in 39 pts, of whom 56.0% had recurrent CMV). Conclusion: In selected countries outside of North America and Europe, conventional therapeutic options for pre-emptive and treatment of CMV infection and CMV disease following HSCT were IV GCV and VGCV. However, premature treatment discontinuation occurred in up to 1 in 8 pts, highlighting an unmet need with current standard of care. Real-world outcomes in pts with refractory CMV (with or without resistance) were scarce and warrants further investigation in this patient population, including therapeutic management.This review was funded by Takeda International AG – Singapore Branch. S-YC has served as a consultant for Takeda Pharmaceutical, and has received research support and payment for lectures from Merck Sharp & Dohme, Pfizer and Gilead. WD has no conflicts of interest to disclose. CMM has received honoraria from Takeda and MSD (advisory board, speaker, educational events, meetings). IS is an employee of Takeda Pharmaceuticals India Pvt Ltd. AS and DD are employees of Takeda International AG – Singapore Branch and hold stock options. MS has received grants from F2G, Gilead, Merck and personal fees from Gilead, Pfizer, Takeda and Roche for work outside of this research. Literature retrieval, analysis and medical writing support were provided by Aurore Bergamasco, Camille Goyer, and Yola Moride of Yolarx Consultants and funded by Takeda International AG – Singapore Branch.

424.1: Epidemiology of Cytomegalovirus Infection and Disease in Hematopoietic Stem Cell Transplant Recipients in Selected Countries Outside of North America and Europe: A Systematic Review

Background: Cytomegalovirus (CMV) is a highly prevalent herpes virus with a seroprevalence higher in South America, Africa, and Asia than in Europe and North America. In hematopoietic stem cell transplant recipients (HSCT), CMV infection is a common opportunistic infection and a major cause of morbidity and mortality. To better understand the epidemiology of CMV infection and disease post-HSCT in selected countries outside of Europe and North America, a systematic review was conducted. Methods: Observational studies that included HSCT recipients (any age) from 15 selected countries in Asia-Pacific, Latin America, Russia and the Middle East were considered (search period: 01 Jan. 2011 – 21 Jul. 2021). Outcomes of interest were incidence, recurrence rates and risk factors of CMV infection and CMV disease, and CMV-related mortality at any time point. Indexed publications (Ovid® MEDLINE and Embase, Cochrane Database of Systematic Reviews and World Health Organization database Global Index Medicus) were searched, supplemented by pragmatic searches of the grey literature and snowballing of references lists. The protocol was registered in PROSPERO (CRD42020205559). Results: A total of 63 studies (range: 33 to 10,206 patients), most conducted in adults (≥ 18 years; n=49 studies, 77.8%) and allogeneic HSCT recipients (n=53, 84.1%), were included in the review. In 43 of 54 studies reporting on incidence of CMV infection, within 1 year post-HSCT, estimates were uniformly distributed between 24.8% and 61.2% (Figure 1). Lower estimates were reported in autologous HSCT recipients (5.3%), and younger patients at the time of transplantation (9.3% in adults with a median age of 25 years and 18.6% in patients aged ≤20 years). Higher estimates (range: 69.4% to 88.2%) were found in 8 studies from China and South Korea, most with a follow-up period > 1 year (median: 27 to 54 months in 5 studies) (Figure 2). Incidence of CMV disease following HSCT was below 20%, with estimates uniformly distributed between 0% and 15.7% in allogeneic HSCT. According to 11 studies, reported rates of CMV recurrence ranged between 19.8% and 37.9%. Commonly reported risk factors for CMV infection or disease in HSCT recipients were high-risk CMV serostatus (R+) (hazard ratio [HR]: 2.6 and 3.7, odds ratio [OR]: 2.2 and 5.4), older age of recipients (HR for each additional year: 1.03-1.04), presence of acute or chronic graft versus host disease (HR: 1.1-2.5), haploidentical HSCT (HR: 2.7-6.4), and use of immunosuppressive agents (OR: 5.0-9.3). CMV-related mortality was reported in up to 10% of patients following HSCT (n=30 studies; period of assessment not reported). Conclusion: Relatively high rates of CMV infection, CMV disease and CMV recurrence were reported post-HSCT, with CMV-related mortality observed in up to 1 in every 10 patients. High rates of CMV infection and disease post-HSCT may impact graft outcomes and increase disease burden in patients post-transplantation.This review was funded by Takeda International AG – Singapore Branch. CMM has received honoraria from Takeda and MSD (advisory board, speaker, educational events, meeting). S-YC has served as a consultant for Takeda Pharmaceutical, and has received research support and payment for lectures from Merck Sharp & Dohme, Pfizer and Gilead. MS has received grants from F2G, Gilead, Merck and personal fees from Gilead, Pfizer, Takeda and Roche for work outside of this research; IS is an employee of Takeda Pharmaceuticals India Pvt Ltd. AS and DD are employees of Takeda International AG – Singapore Branch and hold stock options. WD has no conflicts of interest to disclose. Literature retrieval, analysis and medical writing support were provided by Aurore Bergamasco, Camille Goyer, and Yola Moride of YolaRX Consultants and funded by Takeda International AG – Singapore Branch.

Payments for research participation: Don't tax the Guinea pig.

Under current US statute, payments to research participants are taxable income. This means that even though institutional review boards and researchers agree to specific payment amounts to account for the burden of research, participants are paid less than anticipated, and participants' net payment will vary depending on their home state. Unlike other entities in the research enterprise, who receive incentivizing tax exemptions and credits, research participation is tax dis-incentivized. In addition, incentives and rewards for other socially valuable activities are not taxed. Given these differences and the restrictions on research payments, it is unfair to tax participants on their payments and the statue should be revised.

Race- and sex-based variation in industry research and general payments to medical oncologists in the United States.

11050 Background: Industry partnerships offer financial incentives, prestige, and can facilitate career advancement in oncology. However, not all physicians may have equal access to these opportunities. We hypothesized that physicians who are underrepresented in the medical oncology workforce based on race, ethnicity, and gender receive less industry funding. Methods: All US medical oncologists (MOs) who received ≥1 industry research payment between 2016 and 2020 according to the Open Payments database were included in this retrospective study. Information extracted from Open Payments included MO’s name, institution, research payments (i.e. funding for a research project where the physician is a Principle Investigator), and general payments (i.e. fees not associated with research, such as consulting and travel fees). Additional web searches were conducted using institutional websites, NPPES NPI registry, LinkedIn, Doximity, Scopus, and NIH RePORTER to determine each MO’s race, ethnicity, sex, academic rank, degrees, h-index, institutional NIH research funding rank, and individual receipt of NIH funding. Log-linear regression was performed to identify associations of both industry and general payment data. Results: Of 7,542 physicians meeting inclusion criteria, 69% were male, 65% White, 29% Asian, 2% Black, and 4% Hispanic, which is comparable to the American Medical Association Physician Masterfile figures for MO. The median sum research payment and general payment was $134,857 and $11,537 per physician respectively. Significantly higher mean research payments were associated with an MS (+72%; P = 0.003) or PhD degree (+30%; P = 0.009), h-index (+3%; P &lt; 0.001), top 50 institution rank by NIH funding (+44%; P &lt; 0.001), and associate professor rank (+95%; P &lt; 0.001). Significantly lower mean research payment were observed for Black physicians (-36%; P = 0.022) and those with non-academic affiliation (-47%; P &lt; 0.001). No significant association was observed between sex and research payment. Significantly higher mean general payments were associated with male sex (+46%; P &lt; 0.001), MS degree (+171%; P &lt; 0.001), h-index (+2%; P &lt; 0.001), and Asian race (+72%; P &lt; 0.001). Significantly lower mean general payments were associated with an affiliation with a non-academic practice (-31%; P = 0.012). Conclusions: Black physicians received smaller sums of industry research payments compared to White physicians. Female sex was associated with decreased general payments compared to male sex. Further exploring the underlying mechanisms determining access to industry payments may help facilitate greater equity and inclusivity in oncology.

Financial payments from the pharmaceutical industry to U.S. cancer centers, 2014-2019.

1582 Background: Payments from the pharmaceutical industry to US health care providers were made public through Open Payments in 2013. Since then, industry payments to individual physicians have been studied extensively, but payments to hospitals remain uncharacterized. The goal of this study was to examine trends in industry payments to US cancer centers. Methods: We identified all US cancer centers that were National Comprehensive Cancer Network (NCCN) members or were National Cancer Institute (NCI) comprehensive cancer center as of 2019. Each institution was manually mapped to Open Payments, which contains industry payment data. Where applicable, subsidiary hospitals were included with the parent center. Among the NCCN centers, we used National Plan and Provider Enumeration System data to identify medical oncologists practicing there. Oncologists were linked to Open Payments by name and address. We analyzed “research payments” (RP), which include payments related to preclinical and clinical research, and “general payments” (GP), which include non-research-related payments in categories such as speaker fees, consulting fees, meals, grants, charitable contributions, and licensing fees. We ascertained public research support from NIH data, and included all research project grants. We used correlation analysis and linear regression models to assess the association between industry payments to a cancer center and to oncologists practicing at that center. All dollar values were inflation-adjusted to 2019 dollars using the Consumer Price Index for medical care from the US Bureau of Labor Statistics. Results: Overall industry RP to US cancer centers increased from $527 million in 2014 to $653 million in 2019, while GP increased from $346 million to $786 million. NCI research funding increased from $1,397 million in 2014 to $1,583 million in 2019 (13.3% increase) while overall industry payments (RP+GP) increased from $873 million to $1,439 million (64.8% increase). Industry payments were highest as a portion of total income (industry + NCI) at MD Anderson (64.2%) and lowest at St. Jude (0.1%). Among NCCN institutions, industry payments to cancer centers and the oncologists practicing at those centers were correlated (coefficient = 0.382). A $1,000 increase in GP to a cancer center from a given pharmaceutical company was associated with a $1.00 ($0.61 - $1.30) increase in GP from that company to oncologists at that cancer center. Conclusions: From 2014-2019, cancer center funding from industry sources grew quickly, driven by an increase in non-research payments, and now approaches the amount of public research funding cancer centers receive. Cancer center acceptance of industry payments is associated with increased industry payments to its employed physicians, which are known to sway prescribing practices. These trends raise concerns regarding the ability of these institutions to fulfill their public missions.

Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe.

Creating new therapies often involves drug companies paying healthcare professionals and institutions for research and development (R&D) activities, including clinical trials. However, industry sponsorship can create conflicts of interest (COIs). We analysed approaches to drug company R&D payment disclosure in European countries and the distribution of R&D payments at the country and company level. Using documentary sources and a stakeholder survey we identified country- regulatory approaches to R&D payment disclosure. We reviewed company-level descriptions of disclosure practices in the United Kingdom, a country with a major role in Europe's R&D. We obtained country-level R&D payment data from industry trade groups and public authorities and company-level data from eurosfordocs.eu, a publicly available payments database. We conducted content analysis and descriptive statistical analysis. In 32 of 37 studied countries, all R&D payments were reported without named recipients, following a self-regulatory approach developed by the industry. The methodological descriptions from 125 companies operating in the United Kingdom suggest that within the self-regulatory approach companies had much leeway in deciding what activities and payments were considered as R&D. In five countries, legislation mandated the disclosure of R&D payment recipients, but only in two were payments practically identifiable and analysable. In 17 countries with available data, R&D constituted 19%-82% of all payments reported, with self-regulation associated with higher shares. Available company-level data from three countries with self-regulation suggests that R&D payments were concentrated by big funders, and some companies reported all, or nearly all, payments as R&D. The lack of full disclosure of R&D payments in countries with industry self-regulation leaves considerable sums of money unaccounted for and potentially many COIs undetected. Disclosure mandated by legislation exists in few countries and rarely enhances transparency practically. We recommend a unified European approach to R&D payment disclosure, including clear definitions and a centralised database.

CMS Open Payments Database Analysis of Industry Payments for Foot and Ankle Surgery Research

With decreasing federal funding, the role of industry in supporting medical investigations continues to grow. To increase transparency between physicians and industry, the Centers for Medicare and Medicaid Services introduced the Open Payments Program, providing a searchable database of physician payments from entities including medical device companies. This study describes industry research payments and trends among foot and ankle surgeons. Research Payment Data among foot and ankle surgeons from the Open Payments Database was reviewed from 2013 through 2020. Payment year, value, type, and physician name were collected, and descriptive statistics were presented. Linear regression assessed trends in the number and value of payments. Analysis of variance and subsequent post hoc testing assessed differences in mean payment value. A p value of ≤.05 was considered statistically significant. Overall, 10,872 payments totaling $69,595,393.10 among 446 foot and ankle surgeons were analyzed. No statistically significant increase in number of physicians, payments, or mean payment value per physician was observed from 2013 through 2020. However, the average value of payments in 2019 and 2020 was greater than 2015 and 2017 (p ≤ .05). The top 50 physicians according to cumulative payment value received $54,696,623.10 with 9427 (86.7%) cash and cash-equivalent payments representing the most common payment type overall. Industry continues to provide financial support to foot and ankle surgery research. Results of this investigation spur future studies to examine the relationship between payments and positive results reported by lead investigators in published research.

Industry payments to spine surgeons from 2014 to 2019: trends and comparison of payments to spine surgeons versus all physicians

BACKGROUND CONTEXTThe ethics of industry payments to physicians and the potential impact on healthcare costs and research outcomes have long been topics of debate. Industry payments to spine surgeons are frequently scrutinized. Transparency of industry relationships with physicians provides insight into their possible impact on clinical decision-making and utilization of care. PURPOSE: To analyze trends in medical industry payments to spine surgeons and all physicians from 2014 to 2019, and further evaluate whether specific payments to spine surgeons vary based on company size. STUDY DESIGN/SETTINGCross-sectional investigation of publicly reported Center for Medicare and Medicaid Services (CMS) Open Payments Database (OPD) POPULATION SAMPLEAll US providers listed as receiving industry payments with further evaluation of payments to neurosurgeons and orthopedic spine surgeons. OUTCOME MEASURESMain measures were the magnitude and trends of industry general and research payments and subcategories of general payments, such as royalty/license and consulting fees, to spine surgeons and comparison to all physicians over the six-year period. Variations in payment patterns among spine device manufacturers with the highest reported level of spine surgeon payments in 2019. METHODSFrom 2014 to 2019 publicly reported general and research industry payments in the CMS OPD were analyzed. Trends in payments to all physicians were compared to trends in payments to neurosurgeons and orthopedic spine surgeons. Trends in payment patterns among spine device manufacturers with the highest payments in 2019 were determined. Linear regression analysis was completed to find statistically significant outcomes. RESULTSOur investigation found an aggregate of $42,710,365,196 general and research payments reported to all physicians over the 6-year period, 2.6% ($1,112,936,203) of which went to spine surgeons. Industry general and research payments to spine surgeons decreased by 17.5% ($195,571,109, 2014; $161,283,683, 2019), while increasing by 8.7% ($6,706,208,391, 2014; $7,288,003,832, 2019) to all physicians. Industry research payments to spine surgeons were notably low each year and decreased to only 0.5% of research payments made to all physicians in 2019. Median payment received by spine surgeons as well as the overall distribution of payments to the 75th and 95th percentile significantly increased over the six-year period in comparison to the stable distribution of payments to all physicians. Top eight spine device manufactures with the highest level of spine surgeon payments accounted for 72.9% payments in 2014 but decreased payments by 17.6% to 2019 ($120,409,083.75, 2014; $99,283,264.49, 2019). CONCLUSIONSIndustry general and research payments to all physicians increased from 2014 to 2019 but decreased to spine surgeons, largely due to decreasing payments from eight device manufacturers with the highest level of surgeon payments. A small subset of spine surgeons continues to receive increasing payments. The implications of decreasing investments in research by industry and of large payments made to a small group of spine surgeons bears cautious oversight, both for the future of the specialty and any impact on patient care outcomes.

Industry Payment Trends to Orthopaedic Surgeons From 2014 to 2018: An Analysis of the First 5 Years of the Open Payments Database.

The Open Payments Database (OPD) provides transparent reporting of all payments made to physicians from private industry. Previous studies have described the nature of these financial relationships using the first year of publicly available data. However, long-term trends of these relationships have not been well described. Therefore, we report on the value and distribution of payments within the OPD and analyze trends of payments made to orthopaedic surgeons from 2014 to 2018. The OPD was queried from 2014 to 2018. Payments within the database were categorized into (1) general payments, (2) research interests, and (3) ownership interests. We report on the number, value, and payment trends between private industry and all licensed orthopaedic surgeons who have completed residency training. A total of 631,000 physicians and 23,859 orthopaedic surgeons were included, representing 79.8% of US board-certified orthopaedic surgeons (n = 29,908). Although orthopaedic surgeons received an average of 2.9% of the number of payments made annually, payments to orthopaedic surgeons represented 10.0% of the value of payments made to all physicians. From 2014 to 2018, payments to orthopaedic surgeons increased in both number and value, from 313,194 separate payments ($883.8 million) in 2014 to 335,815 separate payments ($958.6 million) in 2018. In 2018, the top 1% of orthopaedic surgeons (n = 239) accounted for 58.0% ($265.8 million) of all payments to the field. Despite representing only 2.4% of the number of general payments, royalties represented 68.9% ($290.4 million) of the value of general payments to orthopaedic surgeons. Payments for research and education both increased. Industry payments to orthopaedic surgeons represent 10.0% of all physician payments, with increases in payments for research and education. Royalties represented most (68.9%) of the value of general payments made to orthopaedic surgeons. Transparency in physician payments from industry is essential to avoid conflicts of interest. Level III.

Trends in industry-sponsored research in plastic surgery since implementation of the Sunshine Act

Financial contributions from industry for physician-led research have been historically challenging to study in plastic surgery. However, as mandated by the Physician Payments Sunshine Act of 2013, the Open Payments Database (OPD) has increased transparency in payments from industry to physicians. This study aimed to analyze trends in industry-sponsored research funding for plastic surgeons. Using the OPD, research payments from industry made to plastic surgeons from 2014 to 2018 were examined. Total payments and number of payments were recorded by recipient's census region (e.g., Northeast, Midwest, South, West) and therapeutic area (e.g., breast prosthetics/reconstruction, wound healing/tissue engineering, software/instrumentation, biologics, cosmetics/injectables). Payments totaled across 5 years in each therapeutic area for each region were also analyzed. Location of company U.S. headquarters and therapeutic area were recorded. Statistical analyses were performed using SAS 9.4. Brown-Mood test, t test, Kruskal-Wallis, Mann-Whitney, and linear regression tests were used. Aggregated over 5 years, the greatest payment value was allocated to wound healing/tissue engineering, whereas the number of payments was highest in breast prosthetics/reconstruction. Private plastic surgeons receive significantly higher payments compared to academic plastic surgeons. With such findings, greater transparency and additional years of OPD data may provide further insight into industry influence on physician-led research in plastic surgery.

Academic Influence as Reflected by h Index Is Not Associated With Total Industry Payments but Rather With National Institutes of Health Funding Among Academic Orthopaedic Sports Medicine Surgeons

(1) To compare the total number and dollar amount of industry funding and National Institutes of Health (NIH) funding to academic orthopaedic sports medicine surgeons and (2) to examine the impact of academic influence on industry funding and NIH funding to academic orthopaedic sports medicine surgeons. Academic orthopaedic sports medicine surgeons were identified using faculty web pages. Academic influence was approximated by a physician's Hirsch index (h index) and number of publications and obtained from the Scopus database. Total industry payments were acquired through the Open Payments Database, and NIH funding was determined from the NIH website. Statistical analysis was performed using Mann-Whitney U test and Spearman correlations with significance set at P < .05. Physicians who received industry research payments and NIH funding had a significantly higher mean h index and more mean total publications than physicians who did not receive industry research payments and NIH funding. There were no significant differences in h index (P= .374) or number of publications (P= .126) between surgeons receiving industry nonresearch funding and those who did not. h Index and number of publications were both weakly correlated with the amount of industry research and nonresearch funding. Although academic influence is associated with industry research funding and NIH funding, there is no association between measures of academic influence and total industry and industry nonresearch payments. Combined with the weak associations between academic influence and the amount of industry payments, academic influence does not appear to be a major determinant of industry funding to academic orthopaedic sports medicine surgeons. Surgeons should be cognizant of potential conflicts with industry, but the relationship between academic sports medicine surgeons and industry may be less subject to bias than previously believed.

Research Unbundling and COVID-19: Will Europe’s Capital Markets Recovery Package Help?

In 2018, the European financial regulation MiFID II introduced research unbundling rules that banned the bundling of research payments with execution costs. The aim of research unbundling is to increase transparency for investors and to avoid agency conflicts. Opponents argue that research unbundling reduces small and medium-sized enterprise (SME) research and, thereby, SMEs’ financing opportunities because this research can no longer be cross-subsidized by research fees paid for larger companies. The outbreak of COVID-19 and its impact on financial markets fueled intense discussions on rebundling for SMEs. Consequently, in February 2021, the European Commission adopted a Capital Markets Recovery Package that allows bundled research for SMEs below a market capitalization of EUR 1 billion. Against this backdrop, the authors conducted a survey among European market participants to investigate changes in research services due to research unbundling and the COVID-19 pandemic. Moreover, they examine market participants’ views on the expected effects and improvements of the option to rebundle SME research as provided by the recovery package.

Representation of Women in Ophthalmology Receiving Private Industry Funding 2015-2018

To report the representation of female ophthalmologists receiving private industry funding from 2015 through 2018, and to compare to previously observed trends. Retrospective, comparative trend study METHODS: The study population consisted of US ophthalmologists listed in CMS Open Payments Database. Data were reviewed for payments for research, consulting, honoraria, industry grants, faculty and speakers, royalties, and services other than consulting. The primary outcome measure was percentage of female representation compared to male in each sub-category of payment. The percentage of female, board-certified ophthalmologists who practiced in the United States ranged from 21.3% to 24.1%. The total number of reported ophthalmologists with industry ties ranged from 1629 to 1873, of whom between 17.2% and 19.4% were women. Women received significantly less industry compensation by than men in 2015 (median average $3273 vs $4825, P=.003), 2016 ($3600 vs $4750, P=.023), 2017 ($2493 vs $3500, P=.013), and 2018 ($2000 vs $3000, P=.011). Women remained underrepresented in receiving payments for research (ranging from 5.4% of total paid for research to 8.0%), consulting (11%-17.4%), honoraria (6%-14.9%), industry grants (4%-41.2%), royalties and licenses (0.1%-10.2%), faculty and speakers (11.6%-16.4%), and services other than consulting (8.4%-28.9%). Compared to 2013-2014, an increasing proportion of women received industry payments for consulting (P=.012), honoraria (P = .007), royalties and licenses (P = .019), faculty and speakers (P=.007), and services other than consulting (P=.007). Female ophthalmologists remain underrepresented in terms of the percentage of women who receive private industry funding and dollar value of the funding.

Reporting of Financial Conflicts of Interest in Studies of Placental Membrane Allografts.

Objective: To systematically review the accuracy of self-reported financial conflicts of interest (COI) by authors of placental membrane allograft product studies. Approach: A PubMed search identified placental membrane allograft studies published between 2015 and 2019. Industry payments were collected using the Centers for Medicare & Medicaid Services Open Payments database. Self-declared COI were compared with recorded payments. Risk factors for positive product recommendation were determined at study and author levels. Results: Eighty-nine studies (417 authors) were identified. Seventy-five studies (84%) had at least one author receive undisclosed payments. From 2015 to 2019, 5,841 general payments (totaling $15,558,026) and 1,234 research payments (totaling $18,290,062) were made by 46 companies. Travel/lodging was the most commonly reported transaction (34%). Authors were comprised mostly of podiatrists (27%), plastic surgeons (15%), and orthopedic surgeons (15%). Comparative studies were less likely to have a positive product recommendation compared to noncomparative studies (odds ratio [OR] 0.204, 95% confidence interval 0.06-0.066, p = 0.02). Multivariate analysis showed no association between COI discrepancy and product recommendation. Innovation: The accuracy of self-reported financial COI in placental membrane studies is evaluated for the first time. Conclusion: The majority of placental membrane product studies did not declare all industry payments. Whether these payments represent "relevant COI" remains unclear. In addition, not all placental product companies report to the Open Payments database, suggesting that the issue may be even more significant. This study highlights the need for improved definitions of "relevant COI," a standardized reporting system across journals, and the uniform participation of all medical product vendors.

Assessment of Financial Conflicts of Interest Related to the Use of Dermal Substitutes in Burn Management.

This study aims to systematically review the accuracy of the self-reporting of conflicts of interest (COIs) among studies related to the use of dermal substitute products in burn management and evaluate factors associated with increased discrepancies. To do so, a literature search was done to identify studies investigating the use of dermal substitutes in burn management published between 2015 and 2019. Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. Declared COIs were then compared with the listed payments. Studies and authors were considered to have a COI if they received payments totaling more than $100 for each company. A total of 51 studies (322 authors) were included for analysis. Forty studies and 104 authors received at least one payment from the industry. Of these studies, 38 (95%) studies and 91 (88%) authors were found to have a COI discrepancy. From 2015 to 2019, 1391 general payments (totaling $1,696,848) and 108 research payments (totaling $1,849,537) were made by 82 companies. When increasing the threshold on what would be considered an undisclosed payment, the proportion of authors with discrepancies gradually decreased, from 88% of authors with undisclosed payments more than $100 to 27% of authors with undisclosed payments more than $10,000. Author order, journal impact factor, and study type were not significantly associated with increased risk of discrepancy. We found that the majority of studies investigating the use of dermal substitute products for burn management did not accurately declare COI, highlighting the need for a uniform declaration process and greater transparency of industry sponsorship by authors when publishing peer-reviewed burn surgery research papers.