Trends in financial payments from industry to US cancer centers, 2014-2021.

BACKGROUND: Industry payments to US cancer centers are poorly understood. METHODS: US National Cancer Institute (NCI)-designated comprehensive cancer centers were identified (n = 51). Industry payments to NCI-designated comprehensive cancer centers from 2014 to 2021 were obtained from Open Payments and National Institutes of Health (NIH) grant funding from NIH Research Portfolio Online Reporting Tools (RePORT). Given our focus on cancer centers, we measured the subset of industry payments related to cancer drugs specifically and the subset of NIH funding from the NCI. RESULTS: Despite a pandemic-related decline in 2020-2021, cancer-related industry payments to NCI-designated comprehensive cancer centers increased from $482 million in 2014 to $972 million in 2021. Over the same period, NCI research grant funding increased from $2 481  million to $2 724  million. The large majority of nonresearch payments were royalties and licensing payments. CONCLUSION: Industry payments to NCI-designated comprehensive cancer centers increased substantially more than NCI funding in recent years but were also more variable. These trends raise concerns regarding the influence and instability of industry payments.

Drug Promotions Between Ethics, Regulations, and Financial Interests.

BACKGROUND: The promotion of the latest medicines produced by the pharmaceutical industry is an important issue both from an ethical point of view (the level of accessibility, the way research is carried out) and from the point of view of marketing and especially from the lobbying issues raised. AREAS OF UNCERTAINTY: The ethical dilemmas raised by the promotion of new drugs revolve between the need to discover new molecules important for treating a wide range of diseases and the need to establish a battery of ethical rules, absolutely necessary for regulations in the field to be compliant with all ethical principles. DATA SOURCES: A literature search was conducted through PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) using combinations of keywords, including drugs, medical publicity, and pharma marketing plus ethical dilemma. ETHICS AND THERAPEUTIC ADVANCES: The promotion of medicines is governed by advertising laws and regulations in many countries, including at EU level, based on the need for countries to ensure that the promotion and advertising of medicines is truthful, based on information understood by consumers. The ethical analysis of the issues raised is more necessary and complex as the channels used for promotion are more accessible to the population, and the information, easier to obtain, can be the cause of increased self-medication and overeating. Large amounts of money invested in the development of new molecules, but also the risk of scientific fraud through manipulation of data during clinical trials, selective or biased publication of information can have repercussions on the health of the population. CONCLUSIONS: The development of new pharmaceutical molecules is necessary to intervene and treat as many conditions as possible, but marketing must not neglect the observance of ethical principles. The promotion of medicines should be the attribute especially of the medical staff, which should also be a mandatory part of the mechanism for approving the marketing methods and means used by the pharmaceutical companies.

Financial Conflicts of Interest: Payment at the Expense of Patients?

This provocative editorial proposes four steps that can be immediately implemented to reduce the impact of financial conflicts of interest in oncology without stifling collaboration.

ChatGPT for Automated Cross-Checking of Authors' Conflicts of Interest Against Industry Payments.

OBJECTIVE: The Centers for Medicare & Medicaid Services "OpenPayments" database tracks industry payments to US physicians to improve research conflicts of interest (COIs) transparency, but manual cross-checking of articles' authors against this database is labor-intensive. This study aims to assess the potential of large language models (LLMs) like ChatGPT to automate COI data analysis in medical publications. STUDY DESIGN: An observational study analyzing the accuracy of ChatGPT in automating the cross-checking of COI disclosures in medical research articles against the OpenPayments database. SETTING: Publications regarding Food and Drug Administration-approved biologics for chronic rhinosinusitis with nasal polyposis: omalizumab, mepolizumab, and dupilumab. METHODS: First, ChatGPT evaluated author affiliations from PubMed to identify those based in the United States. Second, for author names matching 1 or multiple payment recipients in OpenPayments, ChatGPT undertook a comparative analysis between author affiliation and OpenPayments recipient metadata. Third, ChatGPT scrutinized full article COI statements, producing an intricate matrix of disclosures for each author against each relevant company (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline). A random subset of responses was manually checked for accuracy. RESULTS: In total, 78 relevant articles and 294 unique US authors were included, leading to 980 LLM queries. Manual verification showed accuracies of 100% (200/200; 95% confidence interval [CI]: 98.1%-100%) for country analysis, 97.4% (113/116; 95% CI: 92.7%-99.1%) for matching author affiliations with OpenPayments metadata, and 99.2% (1091/1100; 95% CI: 98.5%-99.6%) for COI statement data extraction. CONCLUSION: LLMs have robust potential to automate author-company-specific COI cross-checking against the OpenPayments database. Our findings pave the way for streamlined, efficient, and accurate COI assessment that could be widely employed across medical research.

Industry Payments to US Physicians by Specialty and Product Type.

This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

Evaluation of non-research and research industry payments to pediatric hematologist/oncologists in the United States between 2013 and 2021.

Financial interactions between healthcare industry and pediatric hematologist/oncologists (PHOs) could be conflicts of interest. Nevertheless, little is known about financial relationships between healthcare industry and PHOs. This cross-sectional analysis of the Open Payments Database examined general and research payments to PHOs from healthcare industry in the United States between 2013 and 2021. Payments to the PHOs were analyzed descriptively. Trends in payments were assessed using generalized estimating equation models. Of 2784 PHOs, 2142 (76.9%) PHOs received payments totaling $187.3 million from the healthcare industry between 2013 and 2021. Approximately, $46.3 million (24.8%) were general payments and $137.7 million (73.5%) were funding for research where PHOs served as principal investigators (associated research funding). Both general payments and associated research funding considerably increased between 2014 and 2019. The number of PHOs receiving general payments and associated research funding annually increased by 2.2% (95% CI: 1.2-3.3%, p < .001) and 5.0% (95% CI: 3.3-6.8%, p < .001) between 2014 and 2019, respectively.

Pharmaceutical Industry Payments to Medical Oncologists in the Netherlands: Trends and Patterns Provided by an Open-Access Transparency Data Set.

PURPOSE: Health care expenditure related to oncologic treatments is skyrocketing although many treatments offer marginal, if any, clinical benefit. Financial conflicts of interest (fCOI) resulting from pharmaceutical industry (pharma) payments to physicians is increasingly recognized as a predictive factor for regulatory board approval and guideline incorporation of low-value treatments. We sought to study the extent to which pharma payments to medical oncologists occur in the Netherlands, the amount of money involved, and whether these occur more frequently and are higher for key opinion leaders (KOLs). METHODS: In our cross-sectional retrospective database study, we used several Dutch open-access databases and extracted data registered between 2019 and 2021. RESULTS: A cumulative amount of €899,863 was paid to 48.8% of the 408 registered medical oncologists. Over time, there was a marked decline in both the proportion of medical oncologists receiving payments (from 40.4% in 2019 to 19.1% in 2021) and the mean annual value of payments (from €2,962 in 2019 to €2,188 in 2021) with the latter mainly resulting from a decline in hospitality-related transactions. KOLs were more likely to receive industry payments and received a higher median payment value. DISCUSSION: Our findings should contribute to the increasing awareness in the Netherlands of the potential effects of fCOI.

Understanding Financial Relationships Between Orthopedic Surgeons and Industry for Research.

OBJECTIVE: This study sought to understand trends in industry payments for research awarded to orthopedic surgeons. MATERIALS AND METHODS: The Centers for Medicare & Medicaid Services Open Payments database was queried for the years 2016 to 2021 for industry payments for research. Financial analyses were performed to understand temporal trends and differences by orthopedic subspecialty and principal investigator characteristics such as sex. The threshold for statistical significance was set at .05. RESULTS: A total of 2014 orthopedic surgeons were identified, among whom 542 adult reconstruction (27%) and 460 sports medicine (23%) surgeons were major beneficiaries. Seventy-one female orthopedic surgeons comprised the minority (4%). Total research payments awarded during the study period aggregated to $266,633,592, with adult reconstruction ($88,819,047; 33%) and sports medicine ($57,949,822; 22%) receiving the highest amounts. Total research payments awarded trended upward yearly except for a decline in 2020 that subsequently rebounded (P<.001). Median annual research payment per orthopedic surgeon was $13,375. Median total industry payments per orthopedic surgeon differed between specialties (P <.001), with the highest amounts for adult reconstruction ($44,063) and sports medicine ($34,567) and the lowest amounts for hand ($12,052) and foot and ankle ($19,233). Median total payments did not differ significantly when stratified by sex (P=.276) and region (P=.906). Specialties in which the respective top three companies offered the majority of the research funding were musculoskeletal oncology (90%), pediatric orthopedics (66%), and shoulder and elbow (64%). CONCLUSION: These results can be used as a primer for orthopedic surgeons seeking to leverage industry relationships to fund translational research. [Orthopedics. 2024;47(3):172-178.].

Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

Evaluation of financial conflicts of interest and quality of evidence in Japanese gastroenterology clinical practice guidelines.

BACKGROUND: Clinical practice guidelines assist healthcare professionals in providing evidence-based care. However, pharmaceutical companies' financial interests often influence guideline content. This study aimed to elucidate the magnitude of financial ties among Japanese gastroenterology guideline authors and the pharmaceutical industry. METHODS: Using pharmaceutical company disclosed payment data, we evaluated financial conflicts of interest (COI) among Japanese Society of Gastroenterology guideline authors between 2016 and 2021. Additionally, we assessed the evidence quality supporting guideline recommendations and associations with financial COI. Finally, we evaluated author COI management during guideline development against global standards. RESULTS: Overall, 88.2% (231/262) of guideline authors received a median of $12 968 (interquartile range [IQR]: $1839-$70 374) in payments between 2016 and 2019 for lectures, writings, and consulting. Chairpersons received significantly higher payments (median: $86 444 [IQR: $15 455-$165 679]). Notably, 41 (15.6%) authors had undeclared payments exceeding declaration requirements. Low or very low-quality evidence supported 41.0% of recommendations. There was a negative association between the median 4-year payment per author and the proportion of recommendations based on low-quality evidence (odds ratio: 0.966 [95% confidence interval [95% CI]: 0.945-0.987], P = 0.002) and positive association with moderate-quality evidence (odds ratio: 1.018 [95% CI: 1.011-1.025], P < 0.001). Still, the Japanese Society of Gastroenterology guideline development process remains less transparent, with insufficient COI policies relative to global standards. CONCLUSION: There were extensive financial COI between pharmaceutical companies and guideline authors, and more than 40% of recommendations were based on low-quality evidence. More rigorous and transparent COI policies for guideline development adhering to global standards are warranted.

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.

Association between Industry Payments and Published Position on Use of Devices for the Treatment of Lower Urinary Tract Symptoms.

OBJECTIVE: To determine the impact of industry payments to authors of opinion articles on the Urolift and Rezum devices. We also examined the extent to which authors omitted acknowledgements of financial conflicts-of-interest. METHODS: We searched Google Scholar for all articles that cite either of the respective pivotal trials for these devices. 2 blinded urologists coded the articles as favorable or neutral. A separate blinded researcher recorded industry payments from the manufacturers using the Open Payments Program database. RESULTS: We identified 29 articles written by 27 unique authors from an initial screening list of 235 articles. Of these articles, 15 (52%) were coded as positive and 14 (48%) were coded as neutral. 20 (74%) authors have accepted payments from the manufacturer of the device. Since 2014, these authors have collectively received $270,000 from NeoTract and $314,000 from Boston Scientific. Of the 20 authors with payments, 9 (45%) received more than $10,000 from either manufacturer. Of authors with payments, 65% (13/20) contributed to only positive articles. Authors who received payments had more than 4 times the number of article contributions than did authors without payments (42 vs 10). Authors of at least one favorable article were more likely to have received payments from the device manufacturers than authors of neutral articles (P = .014, Chi-squared test). Most (80%, 16/20) authors with payments did not report a relevant conflict-of-interest within any of their articles. CONCLUSION: These data suggest a relationship between payments from a manufacturer and positive published position on that company's device. There may be a critical lack of published editorial pieces by authors without financial conflicts of interest.

A Guide to Industry Payments and an Algorithm for Their Management.

BACKGROUND: The Open Payments database was created to increase transparency of industry payment relationships within medicine. The current literature often examines only 1 year of the database. In this study, the authors use 5 years of data to show trends among industry payments to plastic surgeons from 2014 to 2018. In addition, the authors lay out the basics of conflict-of-interest reporting for the new plastic surgeon. Finally, the authors suggest an algorithm for the responsible management of industry relationships. METHODS: This study analyzed nonresearch payments made to plastic surgeons from January 1, 2014, to December 31, 2018. Descriptive statistics were calculated using R Statistical Software and visualized using Tableau. RESULTS: A total of 304,663 payments totaling $140,889,747 were made to 8148 plastic surgeons; 41 percent ($58.28 million) was paid to 50 plastic surgeons in the form of royalty or license payments. With royalties excluded, average and median payments were $276 and $25. The average yearly total per physician was $2028. Of the 14 payment categories, 95 percent of the total amount paid was attributable payments in one of six categories. Seven hundred thirty companies reported payments to plastic surgeons from 2014 to 2018; 15 companies (2 percent) were responsible for 80 percent ($66.34 million) of the total sum paid. Allergan was responsible for $24.45 million (29.6 percent) of this amount. CONCLUSIONS: Although discussions on the proper management of industry relationships continue to evolve, the data in this study illustrate the importance of managing industry relationships. The simple guidelines suggested create a basis for managing industry relationships in the career of the everyday plastic surgeon.

Industry Payments to Plastic Surgeons, 2013 to 2018: Who's Getting Paid?

BACKGROUND: The Physician Payments Sunshine Act of 2010 mandated that all industry payments to physicians be publicly disclosed. To date, industry support of plastic surgeons has not been longitudinally characterized. The authors seek to evaluate payment trends from 2013 to 2018 and characteristics across plastic surgeon recipients of industry payments. METHODS: The authors cross-referenced those in the 2019 American Society of Plastic Surgeons member database with Centers for Medicare & Medicaid Services Open Payments database physician profile identification number indicating industry funds received within the study period. We categorized surgeons by years since American Board of Plastic Surgery certification, practice region, and academic affiliation. RESULTS: A sum of $89,436,100 (247,614 payments) was received by 3855 plastic surgeons. The top 1 percent of earners (n = 39) by dollar amount received 52 percent of industry dollars to plastic surgeons; of these, nine (23 percent) were academic. Overall, 428 surgeons (11 percent) were academic and received comparable dollar amounts from industry as their nonacademic counterparts. Neither geographic location nor years of experience were independent predictors of payments received. The majority of individual transactions were for food and beverage, whereas the majority of industry dollars were typically for royalties or license. CONCLUSIONS: Over half of all industry dollars transferred went to just 1 percent of American Society of Plastic Surgeons members receiving payments between 2013 and 2018. Considerable heterogeneity exists when accounting for payment subcategories.

Mapping conflict of interests: scoping review.

OBJECTIVE: To identify all known ties between the medical product industry and the healthcare ecosystem. DESIGN: Scoping review. METHODS: From initial literature searches and expert input, a map was created to show the network of medical product industry ties across parties and activities in the healthcare ecosystem. Through a scoping review, the ties were then verified, cataloged, and characterized, with data abstracted on types of industry ties (financial, non-financial), applicable policies for conflict of interests, and publicly available data sources. MAIN OUTCOME MEASURES: Presence and types of medical product industry ties to activities and parties, presence of policies for conflict of interests, and publicly available data. RESULTS: A map derived through synthesis of 538 articles from 37 countries shows an extensive network of medical product industry ties to activities and parties in the healthcare ecosystem. Key activities include research, healthcare education, guideline development, formulary selection, and clinical care. Parties include non-profit entities, the healthcare profession, the market supply chain, and government. The medical product industry has direct ties to all parties and some activities through multiple pathways; direct ties extend through interrelationships among parties and activities. The most frequently identified parties were within the healthcare profession, with individual professionals described in 422 (78%) of the included studies. More than half (303, 56%) of the publications documented medical product industry ties to research, with clinical care (156, 29%), health professional education (145, 27%), guideline development (33, 6%), and formulary selection (8, 1%) appearing less often. Policies for conflict of interests exist for some financial and a few non-financial ties; publicly available data sources seldom describe or quantify these ties. CONCLUSIONS: An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patient care from commercial influence and to ensure public trust.