scholarly journals P.013 Conflicts of interest in neurosurgical research - comparing voluntary physician disclosure to mandatory company data

2016 ◽  
Vol 43 (S2) ◽  
pp. S24-S24 ◽  
Author(s):  
PJ McDonald ◽  
ER Shon ◽  
AV Kulkarni
Keyword(s):  
Voluntary Disclosure ◽  
Conflicts Of Interest ◽  
Average Rate ◽  
Industry Data ◽  
Ethical Implications ◽  
The Us ◽  
Financial Conflicts Of Interest ◽  
Author Disclosure ◽  
Open Payments

Background: Industry involvement in neurosurgical research is common, creating financial conflicts of interest (COIs). Most journals require voluntary disclosure of financial COIs. In 2013, the Sunshine Act (SA) was passed in the US, mandating industry disclosure of all payments to physicians. The accuracy of voluntary disclosure can now be determined by comparing voluntary author disclosure with industry data. Methods: We reviewed disclosure statements and calculated rates of voluntary disclosure in major neurosurgical journals before (2011) and after (2013) the Sunshine Act to determine if voluntary disclosure increased after its implementation. We then determined the accuracy of voluntary disclosure in 2013, comparing voluntary disclosure with industry disclosure on the Open Payments Database (OPD). Mean, median and range of industry payments to neurosurgeons were calculated Results: Voluntary disclosure significantly increased in JNS-Spine only (10.7% to 35.4%,p<0.001) after implementation of the SA. The average rate of non-disclosure in all journals studied was 38.3% (Range 33.8%-42.2%)$32,598,522.97 of industry payments were provided to 656 authors in the five-month period studied (Average $49,692.87/author) Conclusions: Voluntary COI disclosure in JNS- Spine increased after implementation of the Sunshine Act. Industry payments to physicians publishing in neurosurgery journals are common and rates of non-disclosure of COIs are high. The ethical implications of COIs and non-disclosure are discussed.

Financial conflicts of interest among the National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline (CPG) Panelists in 2019.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 15-15
Author(s):  
Aakash Desai ◽  
Madhuri Chengappa ◽  
Ronald S. Go ◽  
Thejaswi Poonacha
Keyword(s):  
Expert Witness ◽  
Conflicts Of Interest ◽  
Standard Of Care ◽  
Nccn Guidelines ◽  
Non Hodgkin Lymphoma ◽  
Advisory Boards ◽  
The Us ◽  
Financial Conflicts Of Interest ◽  
Cancer Network ◽  
The Impact

15 Background: CPG are evidence-based guidelines, which serve as a standard of care in practice, quality improvement, and reimbursement. The extent of financial conflicts of Interest (FCOI) in NCCN guidelines has not been recently evaluated. Our study evaluated the extent of FCOI in the NCCN CPG among the 10 most common malignancies in the US. Methods: We examined the latest 2019 version of the NCCN CPG for the 10 most common cancers by incidence in the US. Using disclosure lists, we catalogued the FCOIs for the panelists under various categories outlined in the CPG. We also tabulated the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes a commercial, industry, or institute affiliation reported by a panelist in each episode. Results: Of the 491 panelists on the CPG, 483 (98.3%) completed FCOI disclosures. 224 (46.38%) reported at least 1 FCOI. A total of 1,103 episodes were disclosed with an average of 4.9 episodes per panelist with FCOI. Being a part of scientific advisory boards, consultant, or expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1,103 episodes of FCOI. The top companies were Bristol Myers Squibb, Merck, Genentech and AstraZeneca. Among the top 10 cancers, the prevalence of FCOI were lung (56%), bladder (52%), pancreatic (52%), non-Hodgkin lymphoma (50%), kidney (49%), colorectal (43%), breast (42%), melanoma (40%), prostate (38%), and uterine (32%). Among the panelists with FCOI, 26%, 17%, and 57% reported 1, 2, and > 3 episodes, respectively. There were 127 episodes among the CPG chairs/vice chairs who reported FCOI (mean 6.4). The chairs/vice chairs of uterine, pancreatic, melanoma, and prostate cancer CPG did not have any FCOI. Conclusions: FCOI are very prevalent among the top 10 NCCN CPG panelists. In almost half of the CPG, the majority of the panelists had at least 1 FCOI. Over half of the CPG chairs/vice chairs reported multiple FCOI. Further studies are necessary to determine the impact of these FCOI.

Financial conflicts of interest at three prominent oncology clinical pathway vendors.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6529-6529
Author(s):  
Robert Michael Daly ◽  
Peter Bach ◽  
Ray D. Page
Keyword(s):  
Clinical Pathway ◽  
Conflicts Of Interest ◽  
Clinical Pathways ◽  
Advisory Board ◽  
Treatment Pathway ◽  
Prescribing Behavior ◽  
The Public ◽  
Financial Conflicts Of Interest ◽  
American Society ◽  
Open Payments

6529 Background: The American Society of Clinical Oncology (ASCO) reports that in 2015 62% of oncology practices are adhering to a clinical pathway and 31% are adhering to more than one pathway. ASCO and the American Medical Association have raised concerns about the conflicts of interest of those that design these pathways. Methods: Using the public Centers for Medicare and Medicaid Services Open Payments database, we abstracted the 2015 financial conflicts of interest for the 2016 voting members of the Value Pathways (a combined effort of US Oncology and NCCN), the medical oncology committee chairs for Via Oncology, and the medical advisory board for eviti. We focused on national pathway vendors and on non-research general payments, such as gifts, consulting, and speaker fees. Results: Nearly all involved in pathway development received non-research general payments in 2015, including 92% of US oncology, 84% of NCCN, 84% of Via Oncology, and 69% eviti. The average general payments ranged from $3.5K for US Oncology Value Pathways voting members to $15.3K for NCCN Value Pathways voting members. Eight percent of US Oncology voting members, 19% of the eviti medical advisory board, 28% of Via Oncology chairs, and 42% of NCCN voting members received $10,000 or more in general payments in 2015. Conclusions: Given the prominent role clinical pathways have on oncologists’ prescribing behavior and the often subjective nature of determining on-pathway treatment, pathway vendors should take care to make accessible their conflict of interest policies and elucidate how they manage relationships of concern.Steps would include potentially limiting the number of committee members receiving payments and limiting the amount of general payments to each physician.

Industry-Sponsored Research Payments in Neurosurgery—Analysis of the Open Payments Database From 2014 to 2018

Neurosurgery ◽  
2021 ◽  
Vol 88 (3) ◽  
pp. E250-E258
Author(s):  
Aimen Vanood ◽  
Aryana Sharrak ◽  
Patrick Karabon ◽  
Daniel K Fahim
Keyword(s):  
Medical Research ◽  
Research Funding ◽  
Conflicts Of Interest ◽  
Medical Industry ◽  
Sponsored Research ◽  
Teaching Institution ◽  
Significant Percentage ◽  
Primary Investigator ◽  
Financial Conflicts Of Interest ◽  
Open Payments

Abstract BACKGROUND The Open Payments Database (OPD) started in 2013 to combat financial conflicts of interest between physicians and medical industry. OBJECTIVE To evaluate the first 5 yr of the OPD regarding industry-sponsored research funding (ISRF) in neurosurgery. METHODS The Open Payments Research Payments dataset was examined from 2014 to 2018 for payments where the clinical primary investigator identified their specialty as neurosurgery. RESULTS Between 2014 and 2018, a $106.77 million in ISRF was made to 731 neurosurgeons. Fewer than 11% of neurosurgeons received ISRF yearly. The average received $140 000 in total but the median received $30,000. This was because the highest paid neurosurgeon received $3.56 million. A greater proportion ISRF was made to neurosurgeons affiliated with teaching institutions when compared to other specialties (26.74% vs 20.89%, P = .0021). The proportion of the total value of ISRF distributed to neurosurgery declined from 0.43% of payments to all specialties in 2014 to 0.37% in 2018 (P &lt; .001), but no steady decline was observed from year to year. CONCLUSION ISRF to neurosurgeons comprises a small percentage of research payments made to medical research by industry sponsors. Although a greater percentage of payments are made to neurosurgeons in teaching institutions compared to other specialties, the majority is given to neurosurgeons not affiliated with a teaching institution. A significant percentage of ISRF is given to a small percentage of neurosurgeons. There may be opportunities for more neurosurgeons to engage in industry-sponsored research to advance our field as long as full and complete disclosures can always be made.

scholarly journals Financial Conflicts of Interest of US-Based Authors in Neurology Journals

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000011701
Author(s):  
Jade Smith ◽  
Charlotte Wahle ◽  
James L. Bernat ◽  
Nathaniel M. Robbins
Keyword(s):  
Medical Device ◽  
Conflicts Of Interest ◽  
High Impact ◽  
Clinical Neurology ◽  
Self Disclosure ◽  
Financial Conflicts Of Interest ◽  
Sizeable Minority ◽  
Open Payments ◽  
Financial Relationships

ObjectiveTo detail the scope, nature, and disclosure of financial conflicts of interest (COI) between the pharmaceutical and medical device industries (Industry) and authors in high-impact clinical neurology journals.MethodsUsing the Centers for Medicare and Medicaid Services Open Payments database (OPD), we retrieved information on payments from Industry to 2,000 authors from randomly selected 2016 articles in 5 journals. We categorized payments by type (Research, General, and Associated Research/institutional), sponsoring entity, and year (from 2013 to 2016). Each author's self-disclosures were compared to OPD-listed Industry relationships to measure discordance. Payments were manually reviewed to identify those from manufacturers of products that were directly tested or discussed in the article. We also quantified the prevalence and value of these nondisclosed, relevant COI.ResultsTwo hundred authors from 158 articles had at least one OPD payment. Median/mean annual payments per author were $4,229/$19,586 (General); $1,702/$5,966 (Research); and $67,512/$362,102 (Associated Research). Most neurologists received <$1,000/y (74.6%, 93.0%, and 79.5% for General, Research, and Associated Research, respectively), but a sizeable minority (>10% of authors) received more than $10,000 per year, and several received over $1 million. Of 3,013 payments deemed directly relevant to the article, 39.7% were not self-disclosed by the authors, totaling $3,379,093 ($1,446,603 General; $25,532 Research; $1,906,958 Associated Research).ConclusionIndustry-related financial relationships are prevalent among US-based physicians publishing in major neurology journals, and incomplete self-disclosure is common. As a profession, academic and other neurologists must work to establish firm rules to ensure and manage disclosure of financial COI.

Scope and nature of financial conflicts of interest between neurologists and industry

Neurology ◽  
2019 ◽  
Vol 93 (10) ◽  
pp. 438-449 ◽  
Author(s):  
Nathaniel M. Robbins ◽  
Mark J. Meyer ◽  
James L. Bernat
Keyword(s):  
Medical Device ◽  
Conflicts Of Interest ◽  
Public Trust ◽  
Trends Over Time ◽  
Financial Conflicts Of Interest ◽  
Open Payments ◽  
Over Time ◽  
Financial Relationships

ObjectiveTo detail the scope and nature of financial conflicts of interest (COIs) between neurologists and the pharmaceutical and medical device industries (Industry) using the Centers for Medicare and Medicaid Services Open Payments (OP) database, with a focus on trends from 2013 to 2016.MethodsPayments from Industry to US neurologists were categorized into research payments, general (nonresearch) payments, and value of ownership in Industry. We performed descriptive analyses to detail the scope and nature of these relationships and trends over time.ResultsAt least 9,505 neurologists received at least one payment from Industry each year. From 2013 to 2016, 1.6 million payments totaled $354 million, of which 99.5% of payments and 85.6% of payment value were for general/nonresearch-related payments. Most neurologists (between 65% and 80%) received less than $1,000 per year, but over 200 neurologists each received more than $100,000 during some years. Several received over $1 million. General payments are increasing, research payments are steady, and neurologists' ownership and investments are decreasing.ConclusionsNeurologists have extensive financial relationships with Industry, though this is driven by a well-paid minority. As a profession, we must work to establish firm rules to manage these potential COIs, ensuring that relationships with Industry yield synergistic advances while minimizing bias and maintaining public trust.

scholarly journals A161 PREVALENCE OF FINANCIAL CONFLICTS OF INTEREST (FCOI) AMONG PROPENSITY-SCORE MATCHED RETROSPECTIVE STUDIES EVALUATING BIOLOGIC THERAPEUTICS FOR IBD

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 168-170
Author(s):  
K Elsolh ◽  
D Tham ◽  
M A Scaffidi ◽  
R Bansal ◽  
J Li ◽  
...  
Keyword(s):  
Propensity Score ◽  
Propensity Score Matching ◽  
Retrospective Studies ◽  
Conflicts Of Interest ◽  
Cochrane Library ◽  
High Burden ◽  
Real World Evidence ◽  
Full Text Retrieval ◽  
Financial Conflicts Of Interest ◽  
Matched Comparison

Abstract Background Inflammatory Bowel Disease (IBD) studies have commonly relied on real-world evidence to evaluate different therapies. An emerging idea has been the use of propensity score matching as a statistical method to account for baseline characteristics in IBD patients. In retrospective studies, propensity score matching of patients helps reduce treatment assignment bias and mimic the effects of randomization. Recently, propensity-score matching has become an important tool in IBD studies comparing biologic therapeutics. Biologic medications are among the highest-grossing drugs worldwide, and their pharmaceutical producers make considerable payments to physicians to market them. In spite of this, there is a lack of evidence examining the role of undue industry influence among propensity-score matched comparative studies evaluating biologic therapeutics for IBD. Aims Given the documented association between IBD biologics and FCOI, we hypothesize a high burden of FCOI in propensity-score matched studies. The aim of this study was to evaluate the prevalence of disclosed & undisclosed financial conflicts of Interest (FCOI) in propensity-score matched comparison studies evaluating biologics for IBD. Methods We developed & ran a librarian-reviewed systematic search on EMBASE, MEDLINE, and Cochrane Library databases for all propensity-score matched retrospective studies comparing biologics for the treatment of IBD. Full-text retrieval & screening was performed on all studies in duplicate. 16 articles were identified. Industry payments to authors were only considered FCOI if they were made by a company producing a biologic that was included in the comparison study. Disclosed FCOI were identified by authors’ interests disclosures in full-texts. Any undisclosed FCOI among US authors were identified using the Centre for Medicare and Medicaid Services (CMS) Open Payments Database, which collects industry payments to physicians. Results Based on a preliminary analysis of 16 studies, there was at least one author with a relevant FCOI in 14 (88%) of the 16 studies. 14 studies (88%) had at least one disclosed FCOI, while 6 studies (37.5%) had at least one undisclosed FCOI. Among studies with disclosed FCOI, a mean of 40.2% (SD = 23.4%) of authors/study reported FCOI. Among studies with undisclosed FCOI, a mean of 18.8% (SD = 7.0%) of authors/study reported FCOI. The total dollar value of FCOIs was $1,974,328.3. The median conflict dollar value was $5,576.6 (IQR: $321.6 to $36,394.9). Conclusions We found a high burden of undisclosed FCOI (37.5%) among authors of propensity-score matched studies evaluating IBD biologics. Given the potential for undue industry influence stemming from such payments, authors should ensure better transparency with industry relationships. Funding Agencies None

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