Financial conflicts of interest among presenters, panellists and moderators at haematology and oncology FDA workshops.

OBJECTIVE: To assess the characteristics and financial conflicts of interest of presenters, panellists and moderators at haematology and oncology workshops held jointly with or hosted by the US FDA. SETTING: We included information on all publicly available haematology or oncology FDA workshop agendas held between 1 January 2018 and 31 December 2022. EXPOSURE: General and research payments reported on Open Payments, industry funding to patient advocacy organizations reported on their webpages or 990 tax forms and employment in both pharmaceutical and regulatory settings. RESULTS: Among physicians eligible for payments, 78% received at least one payment from the industry between 2017 and 2021. The mean general payment amount was $82,170 for all years ($16,434 per year) and the median was $14,906 for all years ($2981 per year). Sixty-nine per cent of patient advocacy speakers were representing organizations that received financial support from the pharmaceutical industry. Among those representing regulatory agencies or pharmaceutical companies, 16% had worked in both settings during their careers. CONCLUSIONS AND RELEVANCE: Our findings in this cross-sectional study show a majority of US-based physician presenters at haematology and oncology workshops held jointly with members of the US FDA have some financial conflict of interest with the pharmaceutical industry. These findings support the need for clear disclosures and suggest that a more balanced selection of presenters with fewer conflicts may help to limit bias in discussions between multiple stakeholders.

Conflict of interest disclosure by US cardiothoracic surgeons.

BACKGROUND: Surgeon-industry collaboration is a key driver of advancement in surgical technology and practice. Disclosures of financial relationships between investigators and industries are important to ensure transparent and critical evaluation of literature. METHODS: All American cardiothoracic (CT) surgeons who published in three major CT surgery journals in 2019 were identified. Whether these surgeons disclosed any conflicts of interest was recorded and compared to actual payments received within 5 years of publication as reported by the Centers for Medicare and Medicaid Services data. RESULTS: In the study period, there were 1079 unique manuscripts involving 885 American CT surgeons as authors, which combined for 2719 author instances. Of these, 96.2% of authors (851 of 885) received payments from companies. The authors who received payments produced 2651 author instances (97.4%). Financial disclosure was reported in only 11.4% (301 of 2651) of these instances. In total, 851 surgeons received more than $187 million over 5 years, with the highest-paid surgeon receiving an average of over $5.9 million per year. The largest individual payments were from "Associated Research Funding," with over $115 million being paid to 277 surgeons over 5 years. The top paying company issued over $96.5 million to American CT surgeons over 5 years. CONCLUSIONS: Nearly all the reviewed publications in three top CT surgery journals were by surgeons who received payments from companies, but very few of these payments were recorded as potential conflicts of interest. A more consistent and robust policy of COI disclosure is needed to reduce perceptions of bias.

Conflict of interest policies at Australian medical schools.

BACKGROUND: Pharmaceutical industry exposure is widespread during medical training and may affect education and clinical decision-making. Medical faculties' conflict of interest (COI) policies help to limit this exposure and protect students against commercial influence. AIMS: Our aim was to investigate the prevalence, content and strength of COI policies at Australian medical schools and changes since a previous assessment conducted in 2009. METHODS: We identified policies by searching medical school and host university websites in January 2021, and contacted deans to identify any missed policies. We applied a modified version of a scorecard developed in previous studies to examine the content of COI policies. All data were coded in duplicate. COI policies were rated on a scale from 0 (no policy) to 2 (strong policy) across 11 items per medical school. Oversight mechanisms and sanctions were also assessed, and current policies were compared with the 2009 study. RESULTS: Of 155 potentially relevant policies, 153 were university-wide and two were specific to medical schools. No policies covered sales representatives, on-site sponsored education or free samples. Oversight of consultancies had improved substantially, with 76% of schools requiring preapproval. Disclosure policies, while usually present, were weak, with no public disclosure required. CONCLUSION: We found little indication that Australian medical students are protected from commercial influence on medical education, and there has been limited COI policy development within the past decade. More attention is needed to ensure the independence of medical education in Australia.

Ethics statements in Rheumatology journals: present practices and future directions.

Ethics statements are an essential aspect of research reporting. They aim to ensure the integrity and credibility of scientific research by maintaining high standards of professionalism and placing a strong emphasis on human well-being. Adhering to ethical norms is crucial for promoting data sharing, reproducibility, and overall research integrity. Ethics statements generally include adherence to legislation, disclosure of conflicts of interest, transparency in funding, standards of authorship, ethical treatment of research participants, and the management of sensitive data. The ICMJE, WAME, and COPE organizations offer recommendations to ensure the maintenance of these standards. The significant increase in publication volume in rheumatology research, along with the rise of social media and artificial intelligence, presents new and complex difficulties that require establishing clearer and universally accepted ethical guidelines. Rheumatology journals should prioritize the development of cohesive ethical principles as well as the encouragement of uniform ethics training for researchers, editors, and publishers.

Randomised study of the effects of sense of entitlement and conflict of interest contrarianism on researcher decision-making to work with the alcohol industry.

BACKGROUND: It is well established that the tobacco industry used research funding as a deliberate tactic to subvert science. There has been little wider attention to how researchers think about accepting industry funding. We developed, then tested, hypotheses about two psychological constructs, namely, entitlement and conflict of interest contrarianism (CoI-C) among alcohol researchers who had previously received industry funding. METHODS: A mixed-methods pilot study involved construct and instrument development, followed by an online survey and nested 3-arm randomised trial. We randomly allocated alcohol industry funding recipients to one of three conditions. In two experimental conditions we asked participants questions to remind them (and thus increase the salience) of their sense of entitlement or CoI-C. We compared these groups with a control group who did not receive any reminder. The outcome was a composite measure of openness to working with the alcohol industry. RESULTS: 133 researchers were randomised of whom 79 completed the experiment. The posterior distribution over effect estimates revealed that there was a 94.8% probability that reminding researchers of their CoI-C led them to self-report being more receptive to industry funding, whereas the probability was 68.1% that reminding them of their sense of entitlement did so. Biomedical researchers reported being more open to working with industry than did psychosocial researchers. CONCLUSION: Holding contrarian views on conflict of interest could make researchers more open to working with industry. This study shows how it is possible to study researcher decision-making using quantitative experimental methods.

Evaluating industry payments to editorial board members of otolaryngology journals.

OBJECTIVE: To evaluate the extent of payments from medical device and pharmaceutical companies to editorial board members of leading otolaryngology journals. METHODS: Editorial board members of the top 10 otolaryngology journals from Google Scholar rankings were identified in this cross-sectional study. Payments between 2017 and 2022 were identified via the Open Payments Database from the Centers for Medicare and Medicaid Services. All payment data was adjusted for inflation in 2022 US dollars. Descriptive analyses were performed and journal websites were evaluated for individual editor disclosures. RESULTS: Out of 581 board members, 306 (53 %) received industry payments between 2017 and 2022, median journal percentage 55 % (interquartile range: 26.5 %-73.5 %). A sum of $45.8 million was paid out between 2017 and 2022, comprising $32.0 million in associated research funding, $1.2 million in research payments, $1.4 million in ownership and investment interests, and $11.2 million in general payments. The largest general payments were made out for "services other than consulting and speaking" ($3.9 million), "consulting" ($3.8 million), "travel and lodging" ($0.99 million), "education" ($0.87 million), "royalty or license" ($0.56 million), and "food and beverage" ($0.55 million). Individual editor disclosures were only available for International Forum of Allergy and Rhinology (9 % of all included editors). CONCLUSIONS: Industry payments to editors of otolaryngology journals are not uncommon. We highlight the need for improved reporting of individual editor disclosures for transparency to journal readers and for minimizing biased editorial decisions.

Chymotrypsin and Trypsin Inhibitory Activity of Some Medicinal Plants Collected from Rize (Türkiye).

In this research, the evaluation of in vitro chymotrypsin and trypsin inhibitory activities of ten plant species collected from Rize were aimed, and fractions that showed strong activity were analyzed through HPLC. Daphne pontica L. and Mentha longifolia (L.) L. were found to have the highest chymotrypsin inhibitory activities (87.75 and 84.24 % inhibition). Similarly, the highest trypsin inhibitory activity was observed in D. pontica (%99.93 inhibition), followed by Sambucus ebulus L. flowers (87.47 % inhibition). Extracts showing strong enzyme inhibition were fractioned and subjected to activity tests. The highest chymotrypsin inhibitory activity was observed in the n-hexane fraction of D. pontica (%80.70 inhibition), while the highest trypsin inhibitory activity was found in the n-butanol fraction of S. ebulus (%86.81 inhibition). HPLC studies determined that the 80 % ethanol extract of D. pontica and its dichloromethane and ethyl acetate fractions contained umbelliferone. It was found that chlorogenic acid was present in the 80 % ethanol extracts of S. ebulus flowers. M. longifolia was found to contain chlorogenic acid, caffeic acid, luteolin-7-glucoside, and rosmarinic acid. M. longifolia has been identified as the plant exhibiting the highest antioxidant activity in ABTS and CUPRAC tests, consistent with its high phenolic and flavonoid content.

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.

Impact of Reporting Bias, Conflict of Interest, and Funding Sources on Quality of Orthopaedic Research.

BACKGROUND: Influence of factors like reporting outcomes, conflicts of interest, and funding sources on study outcomes, particularly positive outcomes in orthopedics, remains underexplored. As transparency of partnerships in orthopaedic surgery through conflicts of interest statements has increased over the years, there has been a lack of focus on the value of these partnerships in influencing study outcomes. We aimed to investigate the associations between reporting outcomes, conflicts of interest, and sources of funding on study outcomes. METHODS: We reviewed articles published in 1 year in The Journal of Bone and Joint Surgery, The American Journal of Sports Medicine, and The Journal of Arthroplasty. The abstracts were examined for appropriate inclusion, while the authors' names, academic degrees, funding disclosures, and departmental and institutional affiliations were redacted. There were a total of 1,351 publications reviewed from January 1, 2021 to December 31, 2021. RESULTS: A significant association was found between positive outcomes and reported conflicts of interest (75% versus 25%, P < .001). Likewise, conflicts of interest showed significant association with industry-sponsored studies (88% versus 12%, P < .001) and evidence level > II (72% versus 28%, P < .001). Industry-sponsored research accounted for the highest percentage of studies involving a conflict of interest (88%) and level I studies (12%). CONCLUSIONS: Conflicts of interest are significantly associated with positive outcomes in orthopaedics. Sponsored studies were more inclined to have conflicts of interest and accounted for the majority of level I studies.

Japanese physicians' perceptions of conflicts of interest with pharmaceutical companies: Estimating two different questioning approaches.

Despite being one of the world's largest pharmaceutical markets, interactions between Japanese physicians and pharmaceutical companies often remain opaque. Importantly, potential conflicts of interest associated with these interactions can compromise patient care and increase costs. We conducted an online survey of Japanese physicians to elucidate perspectives on pharmaceutical company promotional activities and how these influence physician prescribing patterns. Anticipating that physicians might downplay their reliance on, or the value of, pharmaceutical company-provided information, the survey incorporated a direct questioning method and an unmatched count technique (UCT) to identify hidden perceptions on factors likely to influence prescribing. Overall, 1080 eligible physicians participated. Of these, 105 (9.7%) self-identified as hospital directors or managers. Surprisingly, nearly twice as many participants responding to direct questioning (18.9%) versus those responding to the UCT (10.1%) asserted that information provided by pharmaceutical companies was important when prescribing medicine. Hospital directors or managers (adjusted odds ratio [adjOR] 2.56, 95% confidence interval [95% CI]: 1.00-6.54, reference = physician without title) and frequent interactions with pharmaceutical sales representatives (adjOR 5.96, 95% CI: 1.88-18.9, reference = rare interaction) significantly valued the information from sales representatives and sponsored lectures when considering prescribing decisions. Additionally, 77.1% of respondents believed that sales representatives provide fair, neutral, or relatively honest and unbiased information about their products. Few Japanese physicians acknowledged the influence of industry-provided information on prescribing patterns. Our study uniquely applies two distinct question formats, providing a novel approach to understanding the depth of physician-industry relationships and the effectiveness of various survey methodologies.

Financial Conflicts of Interest and Industry Funding are Associated With Conclusions Favorable to New Technologies: A Review of Published Economic Analyses in Hip and Knee Arthroplasty.

BACKGROUND: New technologies in hip and knee arthroplasty are commonly evaluated using cost-effectiveness analyses and similar economic assessments. There is a wide variation in the methodology of these studies, introducing the potential for bias. The purpose of this study was to evaluate associations between potential financial conflicts of interest (COI) and the outcomes of economic analyses. We hypothesized that authors' COI and industry funding would be associated with conclusions favorable to a new technology. METHODS: Economic analyses making cost-effectiveness or economic implementation claims on patient-specific instrumentation, robotics, and implants used in hip and knee arthroplasty published from 2010 to 2022 were identified. Papers were evaluated to determine if conclusions were favorable to the new technology being studied. Fisher's exact test was utilized to determine the relationship between the presence of COI and an article's conclusions. RESULTS: Of 43 eligible articles, 76.7% were cost-effectiveness analyses, 23.2% were cost analyses, and 67.4% of articles had conclusions favorable to a technology. Of the 29 articles with favorable conclusions, 26 had an author with a financial COI (89.7%), and 14 had industry funding (48.3%). Of the 33 articles with a financial COI, 26 (78.8%) had favorable conclusions, and of the 16 articles with industry funding, 14 (87.5%) had favorable conclusions. Fisher's exact test revealed a statistically significant association between an article having favorable conclusions and the presence of an author's COI or industry funding (odds ratio, 13.5; 95% CI [confidence interval], 2.3 to 79.9; P = .003). CONCLUSIONS: Financial COIs were present in 79.1% of lower extremity arthroplasty economic analyses on technologies and were associated with an article having conclusions favorable to the new technology. Surgeons and decision-makers should be aware of the variability and assumptions in these studies and the potential bias of the conclusions.

Prescribing Information: Elizabeth B. Connell, the Pill, and the (Woman) Patient's Peace of Mind.

Throughout the 1970s and 1980s, commercialized reproductive technologies experienced a reputational crisis as news about the hormonal birth control pill's possible side effects reportedly caused 18-30% of women to stop taking it. While secondary literature has followed patients' and legislatures' actions, few histories have focused on physicians' responses. How did physicians manage this public crisis of confidence? This article contributes to existing literature through a backstage look at the work of Elizabeth B. Connell (1925-2018), whose wide-ranging career in medicine, academia, government, industry consulting, and popular writing embroiled her at the center of these controversies. To counter critique from legislatures and consumer reformers, Connell became a mediator for medicine in the public sphere, dispensing select information and arguing for limits on others - for the patient's sake. If legislative inquiry's primary havoc was unleashing information, Connell would help the profession moderate it. Because Connell was a woman doctor whom health feminists who were her contemporaries denied was a feminist doctor, the existing scholarship has occluded her. This article reconstructs the contributions of this important and flawed doctor, illuminating how she contorted herself to suit her various public messages, constrained by her conflicting, dual identities as woman and doctor.

Research on commercial milk formulas for young children: A scoping review.

A scoping review of publications about commercial milk formulas intended for or consumed by children 12-36 months (CMF 12-36) was conducted. This review aimed to comprehensively map the existing literature, identify key concepts in the field and understand its evolution through time. A total of 3329 articles were screened and 220 were included, published between 1986 and 2024. Most works were published after 2016 (70.0%) and in high-income countries (71.8%). Original studies were the vast majority (81.8%) of publications. Most publications dealt with feeding practices or analysed the composition and/or contamination of specific products (44.1% and 35.9%), but since the late 2000s, publications about marketing, policy, legislation, and consumer perception started to appear. Most published works (65.5%) did not focus exclusively on CMF 12-36 and included formulas for other demographics or other foods. About half of the works (55.5%) did not consider CMF 12-36 to be a breast milk substitute. We found 81 distinct product denominations used to refer to CMF 12-36, Growing Up Milk was the most common (25.9%). CMF industry was involved in 41.8% of all analysed works, and industry participation and funding were not always clearly informed (22.5% lacked a conflict of interest statement, and 25.5% did not present any information about funding). In the last decade, publications about CMF 12-36 have increased in volume and diversified in scope and subject matter. CMF-industry participation has always been and still is present in the field, so possible vested interests should be taken into account when appreciating the literature.

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.

Association of Device Industry Payments, Physician Supply, and Regional Utilization of Orthopedic and Cardiac Procedures.

BACKGROUND: Geographic variation in high-cost medical procedure utilization in the USA is not fully explained by patient factors but may be influenced by the supply of procedural physicians and marketing payments. OBJECTIVE: To examine the association between physician supply, medical device-related marketing payments to physicians, and utilization of knee arthroplasty (KA) and percutaneous coronary interventions (PCI) within hospital referral regions (HRRs). DESIGN: Cross-sectional analysis of data from the 2018 CMS Open Payments database and procedural utilization data from the CMS Provider Utilization and Payment database. PARTICIPANTS: Medicare-participating procedural cardiologists and orthopedic surgeons. MAIN MEASURES: Regional rates of PCIs and KAs per 100,000 Medicare fee-for-service (FFS) beneficiaries were estimated after adjustment for beneficiary demographics. KEY RESULTS: Across 306 HRRs, there were 109,301 payments (value $17,554,728) to cardiologists for cardiac stents and 68,132 payments (value $40,492,126) to orthopedic surgeons for prosthetic knees. Among HRRs, one additional interventional cardiologist was associated with an increase of 12.9 (CI, 9.3-16.5) PCIs per 100,000 beneficiaries, and one additional orthopedic surgeon was associated with an increase of 20.6 (CI, 16.9-24.4) KAs per 100,000 beneficiaries. A $10,000 increase in gift payments from stent manufacturers was associated with an increase of 26.0 (CI, 5.1-46.9) PCIs per 100,000 beneficiaries, while total and service payments were not associated with greater regional PCI utilization. A $10,000 increase in total payments from knee prosthetic manufacturers was associated with an increase of 2.9 (CI, 1.4-4.5) KAs per 100,000 beneficiaries, while a similar increase in gift and service payments was associated with an increase of 14.5 (CI, 5.0-24.1) and 3.4 (CI, 1.6-5.2) KAs, respectively. CONCLUSIONS: Among Medicare FFS beneficiaries, regional supply of physicians and receipt of industry payments were associated with greater use of PCIs and KAs. Relationships between payments and procedural utilization were more consistent for KAs, a largely elective procedure, compared to PCIs, which may be elective or emergent.

Real-world Imatinib Mesylate Treatment in Patients with Chronic Myeloid Leukemia: The Importance of Molecular Monitoring and the Early Molecular Response.

INTRODUCTION: Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder characterized by the Philadelphia (Ph) chromosome. After the introduction of imatinib mesylate (IM) in 2000, the natural history of the disease changed. Data on the treatment of CML with IM are from randomized clinical trials. Establishing whether these results can be reproduced or if caution is needed when extrapolating data to the general population with CML is essential. OBJECTIVES: To evaluate the molecular response (MR) in patients with chronic-phase CML (CML-CP) not included in clinical studies and correlate them with the responses obtained in clinical trials. METHODS: Between January 2007 and January 2017, 227 patients newly diagnosed with CML-CP treated with IM as first-line treatment were included. This study is an observational, retrospective, and single-center study. RESULTS: At a median follow-up time of 7.3 years, 60.3% of the 227 patients who started IM were still on IM. Early molecular response (EMR) at 3 and 6 months was achieved by 74.2% and 65%, respectively. The median time to a MMR was nine months. The MR4.0 and MR4.5 were 67.2% and 51.1%, respectively. The overall survival (OS), progression-free survival (PFS), and event-free survival (EFS) of the patients who exclusively used IM were 91%, 91%, and 85.1%, respectively. CONCLUSION: The results presented are similar to those described in prospective and randomized trials, demonstrating that the outcomes are reproducible in the real world. EMR at 3 and 6 months reflects better long-term responses, including higher rates of deeper molecular responses. Considering treatment costs, the absence of literature evidence of an impact on overall survival demonstrated by first-line second-generation tyrosine kinase inhibitors (TKIs), and the global OS of 85.8%, imatinib mesylate (IM) is still an excellent therapeutic option.

Conflicts of Interest in the Assessment of Chemicals, Waste, and Pollution.

Pollution by chemicals and waste impacts human and ecosystem health on regional, national, and global scales, resulting, together with climate change and biodiversity loss, in a triple planetary crisis. Consequently, in 2022, countries agreed to establish an intergovernmental science-policy panel (SPP) on chemicals, waste, and pollution prevention, complementary to the existing intergovernmental science-policy bodies on climate change and biodiversity. To ensure the SPP's success, it is imperative to protect it from conflicts of interest (COI). Here, we (i) define and review the implications of COI, and its relevance for the management of chemicals, waste, and pollution; (ii) summarize established tactics to manufacture doubt in favor of vested interests, i.e., to counter scientific evidence and/or to promote misleading narratives favorable to financial interests; and (iii) illustrate these with selected examples. This analysis leads to a review of arguments for and against chemical industry representation in the SPP's work. We further (iv) rebut an assertion voiced by some that the chemical industry should be directly involved in the panel's work because it possesses data on chemicals essential for the panel's activities. Finally, (v) we present steps that should be taken to prevent the detrimental impacts of COI in the work of the SPP. In particular, we propose to include an independent auditor's role in the SPP to ensure that participation and processes follow clear COI rules. Among others, the auditor should evaluate the content of the assessments produced to ensure unbiased representation of information that underpins the SPP's activities.

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.