Associations between pharmaceutical industry payments to physicians and prescription of PARP inhibitors in the United States.

PURPOSE: To evaluate the association between industry payments to physicians related to poly (ADP-ribose) polymerase inhibitors (PARPis) and physicians' prescribing behaviors for PARPis. METHODS: This panel-data analysis used the publicly accessible Open Payments Database and Medicare Part D database between 2017 and 2021. All physicians who reported >10 claims for either olaparib, rucaparib, or niraparib were included in this study. Non-research payments for the PARPis to the physicians from the PARPi manufacturers were extracted from the Open Payments Database. Associations between the physicians' receipt of payments and likelihood of prescribing PARPis were assessed with logistic generalized estimating equations (GEEs). Dose-response associations between the number of payments and prescription volumes and Medicare expenditures were evaluated with linear GEEs. RESULTS: Of the 1686 eligible physician prescribers, 68.7% received one or more non-research payments related to any of the three PARPis from the manufacturers between 2017 and 2021. Median annual payments per physician were $57 for olaparib, $39 for rucaparib, and $62 for niraparib. Receipt of payments for each PARPi was associated with higher odds of prescribing olaparib (odds ratio [OR]: 1.30 [95% CI: 1.14-1.48], p < 0.001), rucaparib (OR: 2.07 [95% CI: 1.58-2.72], p < 0.001), and niraparib (OR: 1.49 [95% CI: 1.22-1.81], p < 0.001). Dose-response effects were observed between the number of annual payments and the number of prescriptions and/or Medicare expenditures for olaparib and rucaparib. CONCLUSION: Non-research payments to physician prescribers of PARP inhibitors from the manufacturers were significantly associated with increased prescriptions and Medicare expenditures for olaparib and rucaparib in the United States.

Trends in Industry Payments to Surgeons During COVID-19.

INTRODUCTION: The Physician Payment Sunshine Act created the Open Payments Program (OPP), which is used to disclose transactions between physicians and industry. The impact of the coronavirus disease (COVID-19) pandemic on this relationship is yet to be determined. Our aim was to compare payments before and after the onset of COVID-19 through the OPP. METHODS: The OPP database was queried between 2014 and 2021 for all general surgery specialties. Payments were classified as general payments and research payments. Payments during 2014-2019 were classified as pre-COVID and compared to payments from 2020 to 2021 which were classified as post-COVID-Outbreak. RESULTS: From 2014 to 2021, 60,245 surgeons received general payments totaling $1.16 billion dollars. Comparing 2019 to 2020, general payments declined from $204.6 million to $108.5 million (-47%) and research payments from $157.3 million to $115.7 million (-26.5%). When comparing trends from 2014-2019 to 2020-2021, the mean number of payments was significantly higher at 394,782 versus 240,778 (P = 0.03) for general payments and 13,671 versus 10,382 (P = 0.03) for research payments. When comparing general payments among various surgical subspecialties, all fields saw a notable decline in general payments. Travel/lodging was the category of payment that saw the most significant change. CONCLUSIONS: Industry payments declined as we entered the COVID-19 pandemic for both general and research payments. This decrease was seen across all surgical subspecialties. These trends in payments seen during the COVID-19 pandemic and the long-term economic impact of COVID-19 on the physician-industry relationship are still developing. Ongoing changes in future years to industry payments are worthy of continued monitoring.

A Nine-Year Investigation of Industry Research and Nonresearch Payments to Emergency Physicians in the United States Between 2014 and 2022.

BACKGROUND: Financial relationships between physicians and the health care industry are common in the United States. Yet, there are limited data on payments to emergency physicians since the 2014 launch of the Open Payments Database. OBJECTIVES: To analyze the trends and characteristics of industry payments to U.S. emergency physicians from 2014 to 2022. METHODS: This retrospective study used the Open Payments Database to examine all general and research payments to all active emergency physicians. Descriptive statistics and generalized estimating equations were employed. RESULTS: Between 2014 and 2022, 50.1% (33,021) of emergency physicians received $640.1 million in payments. Of these, 50.1% received general payments, and 1.2% received research payments. General payments constituted 18.7% ($119.7 million) of the overall industry payments. Median general and research payments were $149 ($49-$401) and $72,083 ($13,903-$370,142), respectively. Compared with other specialties, fewer emergency physicians received general payments, and the amounts were lower. The top 1% of emergency physicians received 80.5% of the general payments. No significant trends in payment amounts were observed from 2014 to 2019, but there was a significant decrease in both types of payments in 2020 due to the COVID-19 pandemic. CONCLUSIONS: The majority of emergency physicians received payments from the health care industry, although these payments were typically minimal compared with other specialties. Payment trends remained consistent from 2014 to 2019, with a notable decrease in 2020 due to the pandemic.

Self-reporting of Conflicts of Interest by Ophthalmology Researchers Compared with the Open Payments Database Industry Reports.

PURPOSE: To evaluate the completeness of conflict-of-interest self-reporting by ophthalmology researchers and to assess factors associated with self-reporting. DESIGN: Cross-sectional observational study. PARTICIPANTS: We evaluated articles published between January and June 2017 in Ophthalmology, JAMA Ophthalmology, the American Journal of Ophthalmology, and Investigative Ophthalmology and Visual Science. To assess more accurately the cases in which an author published multiple articles, we defined a unit of analysis, authorship, for which each author of each article is a unique data point. To enable comparison with the Open Payments Database (OPD), we only included United States physician authorships. METHODS: For each authorship, we defined self-reported relationships as the companies listed in the article's conflict-of-interest disclosures. Based on journal policies, we defined OPD-reported relationships as the list of companies that reported payments to the author within 36 months before submission. MAIN OUTCOME MEASURES: For each authorship, we assessed the proportion of OPD-reported relationships that were self-reported. The primary measurement was the proportion of authorships reporting none of their OPD-reported relationships. RESULTS: Of the 660 total authorships (486 unique authors), 413 authorships (63%) reported none of their OPD-reported relationships, 112 (17%) reported some of them, 9 (1%) reported all of them, and 126 (19%) had 0 relationships. The proportion of authorships reporting none of their relationships did not differ significantly between journals that required reporting of all relationships compared with journals that required reporting only of relevant relationships (adjusted percentage, 61.4% vs. 64.3%; P = 0.46). Authorships with more dollars received during the reporting period showed higher rates of self-reporting (P < 0.001). CONCLUSIONS: Even among journals that required complete reporting, self-reporting was low compared with an industry-maintained database of financial relationships. Deficiencies in reporting may undermine confidence in self-reporting and may compromise the transparency that is needed to interpret research results fairly. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Discrepancies in Conflict-of-Interest Disclosures Among Physicians Receiving Compensation for Monoclonal Antibody Drugs.

BACKGROUND: Monoclonal antibody drugs are widely used, highly marketed, expensive compounds. Relationships between these drug manufacturers and physicians may increase the potential for bias in relevant studies. OBJECTIVE: The aim of this study is to determine the rate of disclosures among physicians receiving compensations for monoclonal antibody drugs (MAbDs). DESIGN: This is a retrospective, population-based, cross-sectional study. PARTICIPANTS: The 50 physicians who received the highest financial compensation for selected MAbDs from 2016 to 2020 were included. MAIN MEASURES: Payment data were obtained from the Open Payments Database, bibliometric data were obtained from SCOPUS, and disclosure data were obtained from relevant publications found in PubMed. The primary outcome was rate of disclosure concordance between self-declared conflict-of-interest and industry-reported payments documented in the Open Payments Database. KEY RESULTS: Of the 50 physicians examined, 74% (N = 37) had publications examined. A cumulative 6170 payments totaling $18,484,228 were analyzed. A total of 418 relevant papers were reviewed. The rate of full disclosure (all relevant financial relationships disclosed) was 39.5%, partial disclosure (some but not all financial relationships disclosed) was 28.0%, and no disclosure was 26.3%. 6.2% did not require disclosure. Publications authored by dermatologists had the highest rate of full disclosure at 49.3%. There was no association between h-index and disclosure rate. Practice guidelines had the highest rate of full disclosure at 69.2% while basic science papers had the lowest (0%). Lastly, substantial variations in specific journal disclosure policies were found. CONCLUSIONS: Substantial inconsistencies were found between self-reported disclosures and the Open Payments Database among physicians receiving high compensation for MAbDs. A policy of full disclosure for all publications should be adopted.

Characteristics of Advanced Practice Nurses Receiving Top Industry Payments and Their Practice Settings: a Cross-sectional Study.

BACKGROUND: The pharmaceutical industry promotes prescribing through the cultivation of key opinion leaders. Advanced practice nurses (APNs) are a growing and influential group of prescribers across generalist and specialty practice. Public reporting of industry payments to APNs allows for exploration of their influence within practice settings. OBJECTIVE: To understand the characteristics of APNs with top industry payments including their positions of influence and other payment recipients at the same address. DESIGN AND SETTING: Cross-sectional study of US national Open Payments reports of industry payments made between January 1, 2021, and December 31, 2021. PARTICIPANTS: APNs who received > $50,000 USD in industry payments for speaking, consulting, and honoraria ("personal fees"). MEASURES: Description of top APN recipients' practice setting type, clinical specialty, presence of other payment recipients, value of payments attributed to the same address, and top manufacturers and therapeutic categories associated with payments to top APN recipients. Structured content analysis of public-facing websites for evidence of APNs' clinical, research, and teaching leadership. RESULTS: A total of 99 APNs received > $50,000 USD in aggregate personal fees and a median $74,080 USD (IQR $57,303-101,702) in aggregate payments. They shared a practice setting with a median of 1 (IQR 0-5) physician and 0 (IQR 0-3) other APN payment recipients and were often the only (39%, 42/109) or the dominant (45%, 30/67) payment recipient in their practice setting. In total, 36% held clinical leadership positions, 25% led scientific research, and 18% had university appointments. Forty-two percent (37/88) owned a clinical practice, including cosmetic clinics (51%, 19/37) and mental/behavioral health clinics (24%, 9/37). CONCLUSIONS: Top APN payment recipients attracted high-value payments in practice settings and specialities associated with high-cost drug development; however, there may be little oversight of APNs' industry relationships. Policy development related to industry relationships must be inclusive of and responsive to the activities of interprofessional providers.

The impact of disclosure of conflicts of interest in studies comparing robot-assisted and laparoscopic cholecystectomies-a persistent problem.

INTRODUCTION: Accurate disclosure of conflicts of interest (COI) is critical to interpretation of study results, especially when industry interests are involved. We reviewed published manuscripts comparing robot-assisted cholecystectomy (RAC) and laparoscopic cholecystectomy (LC) to evaluate the relationship between COI disclosures and conclusions drawn on the procedure benefits and safety profile. METHODS: Searching Pubmed and Embase using key words "cholecystectomy", laparoscopic" and "robotic"/"robot-assisted" retrieved 345 publications. Manuscripts that compared benefits and safety of RAC over LC, had at least one US author and were published between 2014 and 2020 enabling verification of disclosures with reported industry payments in CMS's Open Payments database (OPD) (up to 1 calendar year prior to publication) were included in the analysis (n = 37). RESULTS: Overall, 26 (70%) manuscripts concluded that RAC was equivalent or better than LC (RAC +) and 11 (30%) concluded that RAC was inferior to LC (RAC-). Six manuscripts (5 RAC + and 1 RAC-) did not have clearly stated COI disclosures. Among those that had disclosure statements, authors' disclosures matched OPD records among 17 (81%) of RAC + and 9 (90%) RAC- papers. All 11 RAC- and 17 RAC + (65%) manuscripts were based on retrospective cohort studies. The remaining RAC + papers were based on case studies/series (n = 4), literature review (n = 4) and clinical trial (n = 1). A higher proportion of RAC + (85% vs 45% RAC-) manuscripts used data from a single institution. Authors on RAC + papers received higher amounts of industry payments on average compared to RAC- papers. CONCLUSIONS: It is imperative for authors to understand and accurately disclose their COI while disseminating scientific output. Journals have the responsibility to use a publicly available resource like the OPD to verify authors' disclosures prior to publication to protect the process of scientific authorship which is the foundation of modern surgical care.

Concordance of financial disclosures among faculty at the 2018-2020 SAGES annual meetings.

BACKGROUND: Financial relationships with industry may bias educational content delivered by physicians. SAGES strives to mitigate potential bias, relying on physician self-reporting. Retrospective review of relationships is possible using the Open Payments Database (OPD), a public record of industry-reported payments to US physicians. We aimed to evaluate the effectiveness of the SAGES disclosure process by comparing faculty disclosures to SAGES, faculty disclosures within presentations, and OPD records among speakers at the 2018-2020 SAGES meetings. METHODS: We reviewed all presentations from the SAGES 2018-2020 Annual Meetings. For each invited presentation, all slide-disclosed relationships were recorded. For US physicians, we queried the OPD and recorded relationships ≥ $500 USD in the calendar year prior to presentation. We compared the slide-disclosed relationships with OPD-reported relationships and with those provided to SAGES during the faculty disclosure process. We surveyed a sample of the 2020 annual meeting speakers to analyze potential reasons for discordance. RESULTS: From 2018 to 2020, there were 1,355 invited presentations, of which 1,234 (91%) were available for review. Disclosure slides were present in 1,098 (89%), increasing from 86% in 2018 to 93% in 2020. The proportion of speakers with OPD-reported relationships ≥ $500 increased from 54% in 2018 to 66% in 2020. The total value of OPD relationships decreased from $5.9 million (2018) to $3.3 million (2020) with a concomitant decrease in the proportion with high discordance from 9% in 2018 to 5% in 2020. Among the 2020 speakers with high discordance, the most common explanations for discordance were being unaware of payment or payment outside the 12-month timeframe (55%). CONCLUSIONS: Discordance between financial disclosures reported to SAGES and OPD highlight the need for improvements in the faculty disclosure process. SAGES will continue to streamline this process by incorporating faculty review of their OPD disclosures to ensure all educational programs remain free of commercial bias.

SAGES perspective: professional medical associations, commercial interests, and conflicts of interest.

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.

Intellectual Property and Royalty Payments Among Foot and Ankle Surgery Fellowship Faculty.

Faculty of the American College of Foot and Ankle Surgeons and American Orthopedic Foot and Ankle Society fellowship programs are uniquely positioned to provide advanced clinical and surgical training to fellows. One aspect of this training may include product design and mentorship through the associated intellectual property (IP) and patent timeline. This study describes the payments received and IP held among foot and ankle surgery fellowship faculty. A review of foot and ankle surgeons with royalties or license payments disclosed on the CMS Open Payments Database from 2014 to 2020 was conducted. Members with payments were then cross-referenced with the US Patent Full-Text Database to identify patents held. Fellowship affiliation, practice location, patent office, number of patents, citations, patent h-index, type of patent, and yearly payment values were recorded. Among the 2801 surgeons, 53 fellowship affiliates and 46 nonaffiliates maintained at least 1 patent and royalty/license payment. A total of 576 patents and 19,191 citations were assessed. The median number of patents and citations held by fellowship faculty was 3 and 60, respectively, while the median total payment value reached $165,197.09. Fixation devices comprised most of the patents and citations. Payment value positively correlated with number of patents held (p = .01), citations (p = .007), and patent h-index (p = .01) among fellowship-affiliated surgeons. Foot and ankle surgery fellowship faculty payments for IP are associated with the number and citability of patents held. While a small proportion of faculty were paid for intellectual property, the number of patents held and citations was comparable to other specialties.

Bias amplification in the g-computation algorithm for time-varying treatments: a case study of industry payments and prescription of opioid products.

BACKGROUND: It is often challenging to determine which variables need to be included in the g-computation algorithm under the time-varying setting. Conditioning on instrumental variables (IVs) is known to introduce greater bias when there is unmeasured confounding in the point-treatment settings, and this is also true for near-IVs which are weakly associated with the outcome not through the treatment. However, it is unknown whether adjusting for (near-)IVs amplifies bias in the g-computation algorithm estimators for time-varying treatments compared to the estimators ignoring such variables. We thus aimed to compare the magnitude of bias by adjusting for (near-)IVs across their different relationships with treatments in the time-varying settings. METHODS: After showing a case study of the association between the receipt of industry payments and physicians' opioid prescribing rate in the US, we demonstrated Monte Carlo simulation to investigate the extent to which the bias due to unmeasured confounders is amplified by adjusting for (near-)IV across several g-computation algorithms. RESULTS: In our simulation study, adjusting for a perfect IV of time-varying treatments in the g-computation algorithm increased bias due to unmeasured confounding, particularly when the IV had a strong relationship with the treatment. We also found the increase in bias even adjusting for near-IV when such variable had a very weak association with unmeasured confounders between the treatment and the outcome compared to its association with the time-varying treatments. Instead, this bias amplifying feature was not observed (i.e., bias due to unmeasured confounders decreased) by adjusting for near-IV when it had a stronger association with the unmeasured confounders (≥0.1 correlation coefficient in our multivariate normal setting). CONCLUSION: It would be recommended to avoid adjusting for perfect IV in the g-computation algorithm to obtain a less biased estimate of the time-varying treatment effect. On the other hand, it may be recommended to include near-IV in the algorithm unless their association with unmeasured confounders is very weak. These findings would help researchers to consider the magnitude of bias when adjusting for (near-)IVs and select variables in the g-computation algorithm for the time-varying setting when they are aware of the presence of unmeasured confounding.

Self-Reported Conflicts of Interests and Financial Disclosures in The Journal of Foot & Ankle Surgery: A Systematic Review.

Industry, academia, and professional societies provide financial and in-kind support for physician-lead research; however, the prevalence and role remain unreported. From consultancies to leadership positions, foot and ankle surgeons receive a spectrum of support. To provide transparency between these relationships and published outcomes, journals report conflicts of interest (COI) and financial disclosures (FD). This investigation analyzes self-reported COIs and FDs in The Journal of Foot & Ankle Surgery (JFAS)®. A systematic review of manuscripts reporting COIs and FDs from the January 2008 through November 2020 issues of JFAS was conducted. Editorials, commentaries, and technique articles were excluded. Disclosure type, level of evidence, and affiliated country of authorship were collected. Trends and proportions of articles with disclosures were analyzed from before a published Open Payments Database (OPD) (2008-2013) through 2020. Among 2699 articles, 382 reported a COI or FD. The number of manuscripts with COIs and FDs increased since 2008 (p < .001). The proportion of articles with COIs or FDs was greater after the OPD was published compared to prior (p < .001). Overall, 86.35% of reported COIs were industry related while 37.09% of FDs were hospital, university, or state sponsor affiliated. International authorship was a negative predictor of COIs and FDs (p < .001). Level 3 and 4 studies were 4.60 (95%CI [0.85-24.85]) and 5.56 (95%CI [1.04-29.72]) times as likely to have self-reported a COI compared to level 1 studies, respectively. Level 2 and 5 studies were 0.33 (95%CI [0.04-3.16]) and 0.36 (95%CI [0.04-3.13]) times as likely to have self-reported a FD compared to level 1 studies, respectively. This investigation found an increase in the proportion of manuscripts with self-reported COIs and FDs since first documented in JFAS. These findings illustrate the ubiquity of author industry involvement, though future studies may examine the relevancy of these roles to published research.

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.

Financial relationships between industry and principal investigators of US cooperative group randomized cancer clinical trials.

Financial conflicts of interest (FCOIs) could bias the potentially practice-changing oncologic randomized clinical trials (RCTs) of tomorrow. This investigation characterized the FCOIs of the principal investigators (PIs) of all currently accruing trials of the four (adult) cooperative groups of the National Clinical Trials Network. For our study, the PI list was first compiled, and each name was then searched in the CMS Open Payments database. For each transaction (general payments (GPs) or research funding (RF)), the amount/number/source of payments was recorded. Results showed that from 2014 to 2019, the 91 PIs collectively accepted nearly one-third of a billion dollars ($10 477 023 GPs and $320 096 233 RF). The mean and median GP was $6505 and $945, respectively, and $301 693 and $49 824 RF, respectively. Multivariable Gamma regression analysis revealed that higher GP sums were associated with RCTs involving any type of systemic therapy, and higher RF sums with medical oncologist PIs, trials with phase III components, and RCTs involving radiotherapy (P < .05 for all). Both higher-volume GPs and RF were predicted by PIs having accepted payment(s) from the manufacturer of the drug utilized in their RCT (P < .001 GP, P = .008 RF). Taken together, the main message of this investigation is that FCOIs may be particularly high in PIs of phase III systemic therapy trials, especially if the PI accepted payments from the manufacturer of the drug utilized in their trial. Such RCTs should be thoroughly scrutinized by medical journals, the FDA, and insurance companies for potential "industry bias" that could influence the integrity of their conclusions.

Personal Payments from Pharmaceutical Companies to Authors of Oncology Clinical Practice Guidelines.

BACKGROUND: Oncologists who author clinical practice guidelines frequently have financial relationships with the pharmaceutical industry. It is unknown whether participation on clinical practice guideline committees is associated with differences in the amounts of industry money received. MATERIALS AND METHODS: We conducted a nested case-control study from August 2013 to December 2018. We manually abstracted membership records of National Comprehensive Cancer Network (NCCN) Guidelines committees for the 20 most common cancers and linked to Open Payments. The study sample included medical oncologists selected to join an NCCN Guidelines committee ("joiners") during the study period. Joiners were matched 1:2 to medical oncologists who had no participation on NCCN committees (controls) by gender, NCCN institution, and medical school graduation year. We performed difference-in-differences (DiD) estimation to assess whether selection to an NCCN committee was associated with the dollar value of payments received from industry, using generalized estimating equations to address correlation between matched pairs and between repeated observations of the same pair. RESULTS: During the study period, 54 physicians joined an NCCN Guidelines committee. These physicians received more payments than matched controls in the year prior to joining ($11,259 vs. $3,427; p = .02); this difference did not increase in the year after joining (DiD = $731; p = .45). CONCLUSION: Medical oncologists selected to NCCN Guidelines committees had greater financial ties to industry than their peers. The potential influence of industry in oncology clinical practice guidelines may be reduced through the selection of committee members with fewer ties to industry. IMPLICATIONS FOR PRACTICE: Oncologists who author clinical practice guidelines frequently have financial conflicts of interest with the pharmaceutical industry. This creates concern about the potential for industry influence on guidelines. However, it is unknown whether oncologists who author guidelines have greater industry relationships than their peers. This study compared medical oncologists who were newly selected to join a National Comprehensive Cancer Network (NCCN) Guidelines panel with medical oncologists at the same institutions and at similar career stages. At the time they joined, oncologists joining NCCN Guidelines panels had received more than three times the dollar value of industry payments than their peers. The potential for industry influence may be reduced by the selection of less-conflicted panel members.

Nationwide patterns in industry payments to academic vascular surgeons.

OBJECTIVE: Financial relationships between vascular surgeons and industry are essential to the development and adoption of innovative technology. However, these relationships may establish competing interests. Our objective was to describe publicly available financial transactions between industry and academic vascular surgeons. METHODS: Academic vascular surgeons were identified and characterized on the basis of publicly available data correlated with Accreditation Council for Graduate Medical Education and Association of American Medical Colleges data to identify academic practice settings. Vascular surgeons were linked to Open Payments data for 2017 as reported by the Centers for Medicare & Medicaid Services. Univariate and nonparametric tests were used for analysis. RESULTS: Of 1158 academic vascular surgeons identified, 997 (86%) received industry payments totaling $8,548,034. Overall, the median of total payments received was $814 (interquartile range [IQR], $124-$2863). The top paid decile of vascular surgeons received $29,645 (IQR, $16,128-$61,701). Payments to the top decile accounted for 81% of all payments. Payments did not vary by academic rank but did vary by sex, with male vascular surgeons (n = 954) receiving $889 (IQR, $146-$3217) vs female vascular surgeons (n = 204) receiving $467 (IQR, $87-$1533; P = .002). By leadership role, division chiefs received the highest median payment amount ($1571; IQR, $368-$11,281) compared with department chairs ($424; IQR, $56-$2698) and vascular surgeons without leadership role ($769; IQR, $117-$2592; P = .002). Differences in payments were also seen on the basis of U.S. census region: Northeast, $571 (IQR, $90-2462); Midwest, $590 (IQR, $75-$2364); South, $1085 (IQR, $241-$3405); and West, $1044 (IQR, $161-$4887; P = .001). The most common categories of payments were food and beverage (paid to 85% of all vascular surgeons), travel and lodging (35%), and consulting fees (13%). Among the top decile of vascular surgeons, median payments exceeded $10,000 for three categories: consulting fees, compensation, and honoraria. Payments were made by 178 distinct entities with median total payments of $286 (IQR, $70-$6285). The three top entities paid a total of $5,004,061, which accounted for 59% of all payments. Payments from at least one of the top three entities reached 76% of vascular surgeons. CONCLUSIONS: Most academic vascular surgeons receive publicly reported industry payments that are paid by a limited number of entities, typically for food and beverage or travel and lodging. The top 10% of vascular surgeons received higher median payment amounts, totaling 81% of all industry payments. Vascular surgeons should be aware of publicly reported payment information and the potential for conflicts of interest.

Assessment of self-reported financial conflicts of interest in vascular surgery studies.

OBJECTIVE/BACKGROUND: With increased collaboration between surgeons and industry, there has been a push towards improving transparency of conflicts of interest (COIs). This study aims to determine the accuracy of reporting of COIs among studies in major vascular surgery journals. METHODS: A literature search identified all comparative studies published from January 2018 through December 2018 from three major United States vascular surgery journals (Journal of Vascular Surgery, Vascular and Endovascular Surgery, and Annals of Vascular Surgery). Industry payments were collected using the Centers for Medicare and Medicaid Services Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior. RESULTS: A total of 239 studies (1642 authors) were identified. Two hundred twenty-one studies (92%) and 669 authors (63%) received undisclosed payments when utilizing a cut-off payment amount of $250. In 2018, 10,778 payments (totaling $22,174,578) were made by 145 companies. Food and beverage payments were the most commonly reported transaction (42%), but accounted for only 3% of total reported monetary values. Authors who accurately disclosed payments received significantly higher median general payments compared with authors who did not accurately disclose payments ($56,581 [interquartile range, $2441-$100,551] vs $2361 [interquartile range, $525-$9,699]; P < .001). When stratifying by dollar-amount discrepancy, the proportions of authors receiving undisclosed payments decreased with increasing payment thresholds. Multivariate analysis demonstrated that first and senior authors were both significantly more likely to have undisclosed payments (odds ratio, 2.0; 95% confidence interval, 1.1-3.6 and odds ratio, 2.9; 95% confidence interval, 1.6-5.2, respectively). CONCLUSIONS: There is a significant discordance between self-reported COI in vascular surgery studies compared with payments received in the Centers for Medicare and Medicaid Services Open Payments database. This study highlights the need for increased efforts to both improve definitions of what constitutes a relevant COI and encourage a standardized reporting process for vascular surgery studies.

Increasing Financial Payments From Industry to Medical Oncologists in the United States, 2014-2017.

BACKGROUND: Personal payments from the pharmaceutical industry to US physicians are common and are associated with changes in physicians' clinical practice and interpretation of clinical trial results. We assessed temporal trends in industry payments to oncologists, with particular emphasis on payments to authors of oncology clinical practice guideline and on payments related to immunotherapy drugs. METHODS: We included US physicians with active National Plan and Provider Enumeration System records and demographic data available in the Centers for Medicare & Medicaid Services Physician Compare system who had a specialty type of medical oncology or general internal medicine. Medical oncologists serving on NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Panels were identified manually. Industry payments, and the subset associated with PD-1/PD-L1 drugs, were identified in Open Payments, the federal repository of all transactions of financial value from industry to physicians and teaching hospitals, from 2014 to 2017. RESULTS: There were 13,087 medical oncologists and 85,640 internists who received payments. The mean, annual, per-physician value of payments to oncologists increased from $3,811 in 2014 to $5,854 in 2017, and from $444 to $450 for internists; the median payment increased from $152 to $199 for oncologists and remained at $0 for internists. Oncologists who served on NCCN Guidelines Panels received a greater value in payments and experienced a greater relative increase: mean payments increased from $10,820 in 2014 to $18,977 in 2017, and median payments increased from $500 to $1,366. Among companies marketing PD-1/PD-L1 drugs, mean annual per-oncologist payments associated with PD-1/PD-L1 drugs increased from $28 to $773. Total per-oncologist payments from companies marketing PD-1/PD-L1 drugs experienced a 165% increase from 2014 to 2017, compared with a 31% increase among similar companies not marketing PD-1/PD-L1 drugs. CONCLUSIONS: Pharmaceutical industry payments increased for US oncologists from 2014 to 2017 more than for general internists. The increase was greater among oncologists contributing to clinical practice guidelines and among pharmaceutical companies marketing PD-1/PD-L1 drugs. The increasing flow of money from industry to US oncologists supports ongoing concern regarding commercial interests in guideline development and clinical decision-making.

Pharmaceutical opioid marketing and physician prescribing behavior.

Physicians' relationships with the pharmaceutical industry have recently come under public scrutiny, particularly in the context of opioid drug prescribing. This study examines the effect of doctor-industry marketing interactions on subsequent prescribing patterns of opioids using linked Medicare Part D and Open Payments data for the years 2014-2017. Results indicate that both the number and the dollar-value of marketing visits increase physicians' patented opioid claims. Furthermore, direct-to-physician marketing of safer abuse-deterrent formulations of opioids is the primary driver of positive and persistent spillovers on the prescribing of less safe generic opioids - a result that we show appears to be driven by insurance coverage policies. These findings suggest that pharmaceutical marketing efforts may have unintended public health implications.

Industry Payments to Adult Reconstruction-Trained Orthopedic Surgeons: An Analysis of the Open Payments Database From 2014 to 2019.

BACKGROUND: In recent time, there has been an increased push toward transparency in industry funding toward physicians. The Physician Payments Sunshine Act called for the creation of the Open Payments Database managed by the Centers for Medicare & Medicaid Services. To our knowledge, there have been no studies evaluating the trends in payments among adult reconstruction fellowship-trained orthopedic surgeons. The purpose of this study is to investigate trends in all payments to adult reconstruction-trained orthopedic surgeons from 2014 to 2019. Secondary outcomes included evaluating trends in yearly subpayment categories, regional variations, as well as characterizing the top 5 industry companies. METHODS: A review of the Centers for Medicare & Medicaid Services Open Payments Database was performed to identify all payments to adult reconstruction-trained orthopedic surgeons. A total of 94,265 payments were made to 4911 surgeons accounting for a total of $258,865,231.20 during the study period. Our primary outcome was to assess the trend in median payment per year to individual surgeons. Secondary outcomes included evaluating payment trends with respect to subtype, location as defined by United States Census regions, as well as specifics concerning the top 5 companies. RESULTS: Over the study period, there was a nonsignificant increasing trend in median payment per surgeon (r = 0.49, P = .096). However, there was also a significantly increasing trend in the number of payments per year (r = 0.83, P = .014), as well as the number of surgeons receiving payments (r = 0.88, P = .019). With respect to subcategory payments, there were significantly increasing trends in the median payment per surgeon for education (1054%, r = 0.942, P < .001) and entertainment/food and beverage expenses (20.2%, r = 0.49, P = .020), as well as a significantly decreasing trend for median honoraria payments per surgeon (20.2%, r = -0.04, P = .005). No significant regional trends were identified. Of the top 5 companies, one demonstrated a significantly decreasing trend in median payment per surgeon (21.6%, r = -0.109, P < .001), whereas the others remained unchanged. CONCLUSION: In this study, we found a nonsignificant increasing trend in payments to adult reconstruction-trained surgeons as well as an increasing number of surgeons receiving payments. There were increasing trends in median payment per surgeon for education and entertainment expenses, but a decreasing trend for honoraria payments. No significant regional trends were identified. The majority of the top 5 companies had nonsignificant trends in their payments. Further studies are needed to characterize the disclosure of payments and the impact of industry payments on clinical outcomes. LEVEL OF EVIDENCE: IV.