Association of Financial Conflicts of Interest With Academic Productivity Among Junior Faculty in Hematology and Oncology

INTRODUCTION: Financial conflicts of interest (COIs) represent a common and complex issue in hematology and oncology. However, little is known about the timing of when COIs begin to develop during a career trajectory. We evaluated self-reported COIs for junior faculty members at top cancer centers to determine how these financial relationships correlated with measures of academic career productivity. METHODS: We analyzed data from 230 assistant professors at 10 academic cancer centers. Financial COIs were identified from the CMS Open Payments (Sunshine Act dollars) database. Self-reported COIs were obtained from American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) disclosures, and from disclosures in recent publications. Number of publications and h-index (defined as the largest number of publications [h] such that h publications each have at least h citations) were used as measures of academic productivity. Scatter plots and Spearman correlation coefficients were used to assess the relationship between COIs or Sunshine Act dollars with number of publications and h-index. Linear regression modeling was used to analyze the relationships between COIs or Sunshine Act dollars with number of publications and h-index, adjusting for years of experience since completing fellowship (YSF). RESULTS: A total of 46% of junior faculty had at least 1 COI. Number of COIs reported to ASCO/ASH was positively correlated with total Sunshine Act dollars (Spearman correlation, 0.53; P <.01). The number of COIs and the number of Sunshine Act dollars increased with years in practice (Spearman correlation, 0.38 and 0.25, respectively; P <.01 for both). COIs and Sunshine Act dollars correlated with h-index (Spearman correlation, 0.41 and 0.37, respectively; both P <.01). After adjusting for YSF, linear regression demonstrated that log-transformed h-index and number of publications were associated with Sunshine Act dollars (both P <.01) and COIs (ASCO/ASH) (both P = .01). CONCLUSIONS: Financial COIs increased with number of YSF. Measures of academic productivity were positively correlated with COIs (ASCO/ASH) and Sunshine Act dollars. These data suggest that the cultivation of industry relationships is associated with the early academic productivity of junior faculty.

Industry Payment to Vascular Neurologists: A 6-Year Analysis of the Open Payments Program From 2013 Through 2018.

Background and Purpose- Industry payments to physicians raise concerns regarding conflicts of interest that could impact patient care. We explored nonresearch and nonownership payments from industry to vascular neurologists to identify trends in compensation. Methods- Using Centers for Medicare and Medicaid Services and American Board of Psychiatry and Neurology data, we explored financial relationships between industry and US vascular neurologists from 2013 to 2018. We analyzed payment characteristics, including payment categories, payment distribution among physicians, regional trends, and biomedical manufacturers. Furthermore, we analyzed the top 1% (by compensation) of vascular neurologists with detailed payment categories, their position, and their contribution to stroke guidelines. Results- The number of board certified vascular neurologist increased from 1169 in 2013 to 1746 in 2018. The total payments to vascular neurologist increased from $99 749 in 2013 to $1 032 302 in 2018. During the study period, 16% to 17% of vascular neurologists received industry payments. Total payments from industry and mean physician payments increased yearly over this period, with consulting fee (31.1%) and compensation for services other than consulting (30.7%) being the highest paid categories. The top 10 manufacturers made the majority of the payments, and the top 10 products changed from drug or biological products to devices. Physicians from south region of the United States received the highest total payment (38.72%), which steadily increased. Payments to top 1% vascular neurologists increased from 64% to 79% over the period as payments became less evenly distributed. Among the top 1%, 42% specialized in neuro intervention, 11% contributed to American Heart Association/American Stroke Association guidelines, and around 75% were key leaders in the field. Conclusions- A small proportion of US vascular neurologists consistently received the majority of industry payments, the value of which grew over the study period. Only 11% of the top 1% receiving industry payments have authored American Heart Association/American Stroke Association guidelines, but ≈75% seem to be key leaders in the field. Whether this influences clinical practice and behavior requires further investigation.

Analysis of Open Payments Receipts Among Surgical Faculty at a Large Academic Institution.

BACKGROUND: Section 6002 of the Affordable Care Act, commonly referred to as "The Sunshine Act," is legislation designed to provide transparency to the relationship between physicians and industry. Since 2013, medical product and pharmaceutical manufacturers were required to report any payments made to physicians to the Centers for Medicare and Medicaid Services (CMS). We predicted that most clinical faculty at our institution would be found on the Open Payments website. We elected to investigate payments in relationship to divisions within the department of surgery and the level of professorship. METHODS: All clinical faculty (n = 86) within the department of surgery at our institution were searched within the database: https://openpaymentsdata.cms.gov/. The total amount of payments, number of payments, and the nature of payments (food and beverage, travel and lodging, consulting, education, speaking, entertainment, gifts and honoraria) were recorded for 2017. Comparison by unpaired t-test (or ANOVA) where applicable, significance defined as P < 0.05. RESULTS: Of the 86 faculty studied, 75% were found within the CMS Open Payments database in 2017. The mean amount of payment was $4024 (range $13-152,215). Median amount of payment was $434.90 (range $12.75-152,214.70). Faculty receiving outside compensation varied significantly by division and academic rank (P < 0.05). Plastic surgery had the highest percentage of people receiving any form of payment ($143-$1912) and GI surgery had the largest payments associated with device management ($0-$152,215). The variation seen by rank was driven by a small number of faculty with receipt of large payments at the associate professor level. The median amount of payment was $428.53 (range $13.97-2306.05) for assistant professors, $5328.03 (range $28.30-152,214.70) for Associate Professors, and $753.82 (range $12.75-17,708.65) for full professors. CONCLUSIONS: Reporting of open payments to CMS provides transparency between physicians and industry. The significant relationship of division and rank with open payments database is driven by relatively few faculty. The majority (94%) received either no payments or less than $10,000.

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies.

PURPOSE: The ENCePP Code of Conduct provides a framework for scientifically independent and transparent pharmacoepidemiological research. Despite becoming a landmark reference, practical implementation of key provisions was still limited. The fourth revision defines scientific independence and clarifies uncertainties on the applicability to postauthorisation safety studies requested by regulators. To separate the influence of the funder from the investigator's scientific responsibility, the Code now requires that the lead investigator is not employed by the funding institution. METHOD: To assess how the revised Code fits the ecosystem of noninterventional pharmacoepidemiology research in Europe, we first mapped key recommendations of the revised Code against ISPE Good Pharmacoepidemiology Practices and the ADVANCE Code of Conduct. We surveyed stakeholders to understand perceptions on its value and practical applicability. Representatives from the different stakeholders' groups described their experience and expectations. RESULTS: Unmet needs in pharmacoepidemiological research are fulfilled by providing unique guidance on roles and responsibilities to support scientific independence. The principles of scientific independence and transparency are well understood and reinforce trust in study results; however, around 70% of survey respondents still found some provisions difficult to apply. Representatives from stakeholders' groups found the new version promising, although limitations still exist. CONCLUSION: By clarifying definitions and roles, the latest revision of the Code sets a new standard in the relationship between investigators and funders to support scientific independence of pharmacoepidemiological research. Disseminating and training on the provisions of the Code would help stakeholders to better understand its advantages and promote its adoption in noninterventional research.

Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.

BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

What Do Plastic Surgery Patients Think of Financial Conflicts of Interest and the Sunshine Act?

BACKGROUND: The purpose of this study was to evaluate patients' views of conflicts of interest (COI) and their comprehension of recent legislation known as the Physician Payments Sunshine Act. This report constitutes the first evaluation of plastic surgery patients' views on COI and the government-mandated Sunshine Act. METHODS: This cross-sectional study invited patients at an academic, general plastic surgery outpatient clinic to complete an anonymous survey. The survey contained 25 questions that assessed respondents' perceptions of physician COI and awareness of the Sunshine Act. Analyses were performed to examine whether perspectives on COI and the Sunshine Act varied by level of education or age. RESULTS: A total of 361 individuals completed the survey (90% response rate). More than half of respondents with an opinion believed that COI would affect their physician's clinical decision-making (n = 152, 52.9%). Although almost three fourths (n = 196, 71.2%) believed that COI should be regulated and COI information reported to a government agency, the majority were not aware of the Sunshine Act before this survey (n = 277, 81.2%) and had never accessed the database (n = 327, 95.9%). More than half of patients (n = 161, 59.2%) stated that they would access a publicly available database with physicians' COI information. A larger proportion of older and educated patients believed that regulation of physicians' COI was important (P < 0.001). CONCLUSIONS: Awareness of and access to plastic surgeon COI information is low among plastic surgery patients. Older and more educated patients believed that transparency regarding COI is important with regard to their clinical care.

Conflicts of Interest in Human Subject Research: The Insufficiency of U.S. and International Standards.

Researchers, as well as individuals and institutions that oversee their conduct, sometimes have conflicts of interest that weaken or render ineffective efforts to protect human research subjects. This article analyzes United States and international standards used to address conflicts of interest and reviews evidence regarding compliance. It finds current standards are insufficient and recommends that the federal government and international organizations adopt stronger legal standards that require resolving most significant conflicts of interest and specifying how to manage conflicts of interest not resolved.

Ethical Issues Pertaining to Conflicts of Interest Between Neurologists and the Pharmaceutical and Medical Device Industries.

A conflict of interest (COI) exists when a physician's professional responsibilities are compromised by personal or financial relationships. COIs between physicians and the pharmaceutical or medical device industry (Industry) are common. Collaborations with Industry have many potential benefits, but also raise potential ethical pitfalls. Industry-related COIs have widespread influence on medical education, research, and clinical practice, and therefore have profound implications for the integrity of the field of medicine. Full disclosure is an important step toward mitigating COI but does not redress subconscious accompanying biases. I review the spectrum of potential COI faced by physicians, with a focus on the ethics surrounding the relationship between neurologists and Industry. Other financial and nonfinancial COIs that influence neurologists and nonindividual entities, such as academic institutions, medical journals, and professional societies, are also discussed. Solutions ranging from disclosure to avoidance and recusal are briefly considered.

Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.

BACKGROUND: The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD versus self-reported conflicts of interest (COI) is unknown. MATERIALS AND METHODS: Our objectives were to compare (1) industry and self-disclosed COI in clinical literature, (2) payments within each disclosure level, and (3) industry- and self-disclosed COI and payments by specialty. This was an observational study. PubMed was searched for clinical studies accepted for publication from January 2014 to June 2016. Author and OPD-disclosed COIs were compared. Articles and authors were divided into full disclosure, incomplete industry disclosure, incomplete self-disclosure, and no COI. Primary outcome (differences in reported COI per article) was assessed using McNemar's test. Payment differences were compared using Kruskal-Wallis test. RESULTS: OPD- and self-disclosed COI differed (65.0% discordance rate by article, P < 0.001). Percentages of authors within each disclosure category differed between specialties (P < 0.001). Hematology articles exhibited the highest discordance rate (79.0%) and received the highest median payment for incomplete self-disclosure ($30,812). CONCLUSIONS: Significant discordance exists between self- and OPD-reported COI. Additional research is needed to determine reasons for these differences.

The Dawn of Transparency: Insights from the Physician Payment Sunshine Act in Plastic Surgery.

BACKGROUND: The Physician Payments Sunshine Act (PSSA) is a government initiative that requires all biomedical companies to publicly disclose payments to physicians through the Open Payments Program (OPP). The goal of this study was to use the OPP database and evaluate all nonresearch-related financial transactions between plastic surgeons and biomedical companies. METHODS: Using the first wave of OPP data published on September 30, 2014, we studied the national distribution of industry payments made to plastic surgeons during a 5-month period. We explored whether a plastic surgeon's scientific productivity (as determined by their h-index), practice setting (private versus academic), geographic location, and subspecialty were associated with payment amount. RESULTS: Plastic surgeons (N = 4195) received a total of US $5,278,613. The median (IQR) payment to a plastic surgeon was US $115 (US $35-298); mean, US $158. The largest payment to an individual was US $341,384. The largest payment category was non-CEP speaker fees (US $1,709,930) followed by consulting fees (US $1,403,770). Plastic surgeons in private practice received higher payments per surgeon compared with surgeons in academic practice (median [IQR], US $165 [US $81-$441] vs median [IQR], US $112 [US $33-$291], rank-sum P < 0.001). Among academic plastic surgeons, a higher h-index was associated with 77% greater chance of receiving at least US $1000 in total payments (RR/10 unit h-index increase = 1.47 1.772.11, P < 0.001). This association was not seen among plastic surgeons in private practice (RR = 0.89 1.091.32, P < 0.4). CONCLUSIONS: Plastic surgeons in private practice receive higher payments from industry. Among academic plastic surgeons, higher payments were associated with higher h-indices.

Deciphering the Sunshine Act: Transparency Regulation and Financial Conflicts in Health Care.

The Physician Payments Sunshine Act ("Sunshine Act"), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges. Capturing all the relevant information about financial relationships and reporting it with sufficient contextual and comparative data has proven disappointingly difficult. In addition, the law suffers from uncertainty and poor design as to the intended audience. Indeed, there is strong reason to believe that it will not significantly impact decision-making of primary recipients like patients. Yet the Sunshine Act nonetheless retains important and perhaps underappreciated value. From the almost four years of information generated, we have learned that industry-medicine financial ties vary significantly by physician specialty, and somewhat by physician gender. In many medical fields the distribution of top dollar payments tends to be heavily skewed to a few recipients, all of which have important implications for optimal management of financial conflicts and for health policy more generally. Accordingly, the Sunshine Act's greatest potential is not guiding decisions of individual patients or physicians, but its downstream effects. This Article traces how secondary audiences, such as regulators, watchdogs, and counsel are already starting to make productive use of Sunshine Act information. Public reporting has, for example, made more feasible linking industry payment information with Medicare reimbursement data. As a result, policymakers can more closely examine correlations between industry spending directed at individual physicians and their prescribing and referral decisions. Moreover, savvy counsel are recognizing that Sunshine Act information provides explosive evidence in private civil litigation and this Article explores the first wave of cases.

Interactions with industry under the Sunshine Act: an example from gynecologic oncology.

THE PROBLEM: Clinicians may be unaware that industry payments to physicians are now publicly searchable under the Physician Payments Sunshine Act. Furthermore, the extent of industry's financial involvement in subspecialty practice has not been previously accessible. As an example, 6948 direct, research-unrelated payments totaling $1,957,004 were made to 765 gynecologic oncologists in 2014, the first full year of data available. A total of 153 companies reported at least 1 payment; however, the 10 manufacturers reporting the highest total payment amount accounted for 82% of all payments to physicians. In all, 48 gynecologic oncologists received >$10,000 from manufacturers, accounting for $1,202,228, or 61%, of total payments. A SOLUTION: Obstetrician-gynecologists, including gynecologic oncologists, should be aware of their publicly reported payments from industry and ensure reports' accuracy. Professional organizations, including the Society of Gynecologic Oncology (SGO), should strongly consider proactively developing guidelines regarding interactions with industry for their general memberships.

Sunshine Act: shedding light on inaccurate disclosures at a gynecologic annual meeting.

BACKGROUND: Physicians and hospital systems often have relationships with biomedical manufacturers to develop new ideas, products, and further education. Because this relationship can influence medical research and practice, reporting disclosures are necessary to reveal any potential bias and inform consumers. The Sunshine Act was created to develop a new reporting system of these financial relationships called the Open Payments database. Currently all disclosures submitted with research to scientific meetings are at the discretion of the physician. We hypothesized that financial relationships between authors and the medical industry are underreported. OBJECTIVES: We aimed to describe concordance between physicians' financial disclosures listed in the abstract book from the 41st annual scientific meeting of the Society of Gynecologic Surgeons to physician payments reported to the Center for Medicaid and Medicare Services Open Payments database for the same year. STUDY DESIGN: Authors and scientific committee members responsible for the content of the 41st annual scientific meeting of the Society of Gynecologic Surgeons were identified from the published abstract book; each abstract listed disclosures for each author. Abstract disclosures were compared with the transactions recorded on the Center for Medicaid and Medicare Services Open Payments database for concordance. Two authors reviewed each nondisclosed Center for Medicaid and Medicare Services listing to determine the relatedness between the company listed on the Center for Medicaid and Medicare Services and abstract content. RESULTS: Abstracts and disclosures of 335 physicians meeting inclusion criteria were reviewed. A total of 209 of 335 physicians (62%) had transactions reported in the Center for Medicaid and Medicare Services, which totaled $1.99 million. Twenty-four of 335 physicians (7%) listed companies with their abstracts; 5 of those 24 physicians were concordant with the Center for Medicaid and Medicare Services. The total amount of all nondisclosed transactions was $1.3 million. Transactions reported in the Center for Medicaid and Medicare Services associated with a single physician ranged from $11.72 to $405,903.36. Of the 209 physicians with Center for Medicaid and Medicare Services transactions that were not disclosed, the majority (68%) had at least 1 company listed in the Center for Medicaid and Medicare Services that was determined after review to be related to the subject of their abstract. CONCLUSION: Voluntary disclosure of financial relationships was poor, and the majority of unlisted disclosures in the abstract book were companies related to the scientific content of the abstract. Better transparency is needed by physicians responsible for the content presented at gynecological scientific meetings.