Cross-sectional analysis of financial relationships between board certified allergists and the pharmaceutical industry in Japan.

BACKGROUND: Financial interactions between pharmaceutical companies and physicians lead to conflicts of interest. This study examines the extent and trends of non-research payments made by pharmaceutical companies to board-certified allergists in Japan between 2016 and 2020. METHODS: A retrospective analysis of disclosed payment data from pharmaceutical companies affiliated with the Japanese Pharmaceutical Manufacturers Association was conducted. The study focused on non-research payments for lecturing, consulting, and manuscript drafting made to board-certified allergists from 2016 to 2020. We performed descriptive analyses on payment data. Trends were analyzed using generalized estimating equation models. RESULTS: Of the 3,943 board-certified allergists, 2,398 (60.8%) received non-research payments totaling $43.4 million over five years. Lecturing fees comprised 85.7% ($37.2 million) of the total payment amounts. For allergists who received at least one payment, the median amount per allergist was $3,106 (interquartile range: $966 - $12,124), in contrast to a mean of $18,092 (standard deviation: $49,233) over the five-year span. The top 1% and 10% of these allergists accounted for 20.8% and 68.8% of all non-research payments, respectively. The annual payment amounts significantly increased by 7.2% annual increase (95% CI: 4.4 - 10.0%, p < 0.001) each year until 2019, but saw a significant decrease in 2020 amid the COVID-19 pandemic. CONCLUSION: The majority of allergists received non-research payments, with a notable concentration among a small group. Payments increased annually until the pandemic's onset, which coincided with a substantial decrease. Further research is needed to explore the implications of these financial interactions on clinical practice and patient care in Japan.

Pharmaceutical industry payments to NHS trusts in England: A four-year analysis of the Disclosure UK database.

INTRODUCTION: Although hospitals are key health service providers, their financial ties to drug companies are little understood. We examine non-research pharmaceutical industry payments to English National Health Service (NHS) trusts-hospital groupings providing secondary and tertiary care. METHODS: We extracted data from the industry-run Disclosure UK database, analysing it descriptively and using the Jonckheere-Terpstra test to establish whether a statistically significant time trend existed in the median values of individual payments. We explained payment value and number per trust with random effects models, using selected trust characteristics as predictors. RESULTS: Drug companies reported paying £60,253,421 to 234 trusts, representing between 90.0% and 92.0% of all trusts in England between 2015 and 2018. As a share of payments to all healthcare organisations, the number of payments rose from 38.6% to 39.5%, but their value dropped from 33.0% to 23.6%. The number of payments for fees for service and consultancy and contributions to costs of events increased by 61.5% and 29.4%. The median payment value decreased significantly for trusts overall (from £2,250.8 to £1,758.5), including those with lower autonomy from central government; providing acute services; and from half of England's regions. The random effects model showed that acute trusts received significantly more money on average than trusts with all other service profiles; and trusts from East England received significantly less than those from London. However, trusts enjoying greater autonomy from government did not receive significantly more money than others. Trusts also received significantly less money in 2018 than in 2015. CONCLUSION: NHS trusts had extensive pharmaceutical industry ties but were losing importance as payment targets relative to other healthcare organisations. Industry payment strategies shifted towards events sponsorship, consultancies, and smaller payments. Trusts with specific service and geographical profiles were prioritised. Understanding corporate payments across the health system requires more granular disclosure data.

Industry funding of patient organisations in the UK: a retrospective study of commercial determinants, funding concentration and disease prevalence.

OBJECTIVES: To assess the relationship between UK-based patient organisation funding and companies' commercial interests in rare and non-rare diseases in 2020. DESIGN: Retrospective analysis of the value and volume of payments from pharmaceutical companies to patient organisations in the UK matched with data on the conditions supported by patient organisations and drugs in companies' approved portfolios and research and development pipelines. SETTING: UK. PARTICIPANTS: 74 pharmaceutical companies making payments to 341 UK-based patient organisations. MAIN OUTCOME MEASURES: Alignment between the commercial interests of pharmaceutical companies and the disease area focus of patient organisations; difference in the volume and value of payments to patient organisations broken down by prevalence of conditions; industry funding concentration, measured as the number of companies funding each patient organisation, the share of overall industry funding coming from each contributing company and the share of industry funding of each organisation comprised by the single highest payments. RESULTS: 1422 payments were made by 74 companies to 341 patient organisations. Almost all funds (90%) from pharmaceutical companies were directed to patient organisations that are aligned with companies' approved drug portfolios and research and development pipelines. Despite rare diseases affecting less than 5% of the UK population, more than 20% of all payments were directed to patient organisations which target such conditions. Patient organisations focusing on rare diseases relied on payments from fewer companies (p value=0.0031) compared to organisations focusing on non-rare diseases. CONCLUSIONS: Companies predominantly funded patient organisations operating in therapeutic areas relevant to companies' portfolio or drug development pipeline. Patient organisations focusing on rare diseases received more funding relative to the number of patients affected by these conditions and relied more heavily on payments from fewer companies compared to organisations targeting non-rare diseases. Increased independence of patient organisations could help avoid conflicts of interest.

Interactions between Australian cancer physicians and the pharmaceutical industry: a qualitative study.

OBJECTIVES: To understand how and why Australian cancer physicians interact with the pharmaceutical industry. DESIGN: Qualitative study using semistructured interviews, performed by a medical oncologist. Thematic analysis using a combination of deductive and inductive codes. SETTING: Given the evidence on industry influences on clinical practice and the importance to the market of oncology drugs, we sought to better understand cancer physicians' experiences. Practising consultant medical oncologists and clinical haematologists from four Australian states were interviewed over Zoom. PARTICIPANTS: 16 cancer physicians were interviewed between November 2021 and March 2022, from 37 invited (response rate 43%). Most were medical oncologists (n=12 of 16, 75%) and male (n=9 of 16, 56%). OUTCOME MEASURES: The analysis of all interviews was based on grounded theory. Transcripts were coded and then codes formed into themes with supporting quotes. The themes were then placed into categories, used to describe the broad areas into which the themes could be grouped. RESULTS: Six themes were identified that fell within two broad categories: cancer physicians' views and experiences of interactions and management of these interactions. Views and experiences included: the transactional nature of relationships, risks of research dependence, ethical challenges and varied attitudes based on interaction type. Management themes included: lack of useful guidance and reduced interactions during the COVID-19 pandemic. These led to an overarching seventh theme, on the desire for a 'middle road'. Cancer physicians identified the transactional nature of industry relationships and felt uncomfortable with several types of interactions, including those with sales representatives. Most wanted less contact with industry, and the forced separation that occurred with the COVID-19 pandemic was generally welcome. CONCLUSIONS: Cancer physicians may have difficulty balancing the perceived need to interact with industry in modern cancer care while maintaining distance to minimise conflicts of interest. Further research is needed to assess management strategies in this area.

Conflicts of Interest Among Infectious Diseases Clinical Practice Guideline Authors and the Pharmaceutical Industry.

This cross-sectional study assesses the prevalence of conflicts of interest (COI) associated with guideline-recommended drugs among Infectious Diseases Society of America clinical practice guideline authors and compliance with the Council on Medical Specialty Societies and Institute of Medicine guidelines.

[Financial conflict of interest and anti-cancer drugs: Why the NTVG's stance to exclude pharma-advertisement is of importance.] / Financiële belangen en oncologische geneesmiddelen.

The number of new oncological treatments is increasing rapidly, even though many offer limited benefit to patients. In these cases, the scientific research leading to approvals is marred by shortcomings. Nonetheless, many drugs of limited value are approved by regulatory agencies. One of the factors contributing thereto is financial conflict of interest (FCI) with the pharmaceutical industry (Pharma). This occurs at different levels, including researchers, opinion leaders and editors of medical journals. FCI contributes to patient exposure to treatments that offer limited or no benefit and to unjust spending of valuable resources while providing large revenues for Pharma. The important step of the 'NederlandsTijdschriftvoorGeneeskunde' (NTVG) to omit all pharmaceutical advertisement as well as advertisement for pharmaceutical industry sponsored medical education sends an important signal and is a first step to revalue the important relationship with the pharmaceutical industry.

¿Debe la industria farmacéutica participar en la formación médica continuada? / Should the pharmaceutical industry be involved in continuing medical education?

Introducción En julio del 2020 se presentó en el Congreso de los Diputados español una propuesta de ley que proponía que la formación médica continuada se financiase exclusivamente por las Administraciones públicas, prohibiendo la participación privada. Objetivos Recoger la opinión de médicos y farmacéuticos sobre la propuesta de ley, conocer qué piensan acerca de la financiación de la formación médica continuada y su posible conflicto de interés. Métodos Estudio descriptivo transversal a través de una encuesta de opinión, voluntaria y anonimizada, dirigida a médicos y farmacéuticos hospitalarios. Resultados Se analizan 435 encuestas, el 59,8% de mujeres. El 87,6% son facultativos especialistas y el 77,2% pertenece a especialidades médicas. El 55,2% no está de acuerdo con la propuesta de ley. El 92,4% se muestra de acuerdo con que el Estado y las instituciones privadas subvencionen la formación de sus trabajadores. El 54,2% está en desacuerdo con que cada profesional financie su formación, mientras que el 14% está de acuerdo. El 19,8% no se ha sentido cómodo cuando le han financiado un curso o congreso y el 74,5% considera que la participación privada de la financiación no influye en la prescripción. Conclusiones La mayoría de los encuestados no está de acuerdo con una propuesta de ley que pretende prohibir que la industria farmacéutica financie la formación médica continuada. Casi todos se muestran de acuerdo con que el Estado y las instituciones privadas subvencionen la formación de sus trabajadores. En general, los encuestados no detectan conflictos de interés en su relación con la industria (AU)

Introduction In July 2020, a draft bill was introduced in Spain's Congress which proposed that continuing medical education be funded exclusively by the Spanish government, barring involvement from private entities. Aims This work aims to gather physicians’ and pharmacists’ opinions on this draft bill, learn what they think about the funding of continuing medical education and possible conflicts of interest. Methods This work is a descriptive cross-sectional study conducted via voluntary anonymous surveys aimed at physicians and hospital pharmacists. Results Four hundred thirty-five surveys were analyzed, 59.8% of which were from women. Of the respondents, 87.6% were specialist physicians and 77.2% were part of a specialist department. A total of 55.2% did not agree with the draft bill while 92.4% agreed that the government and private institutes should subsidize training for their workers. Furthermore, 52.4% disagreed that each professional should pay for his or her own training while 14% agreed they should. A total of 19.8% have felt uncomfortable when a course or conference has been paid for by another entity and 74.5% believe that the involvement of private entities in funding does not influence prescribing. Conclusions The majority of those surveyed did not agree with a draft bill aimed at prohibiting the pharmaceutical industry from funding continuing medical education. Nearly all agreed that the government and private institutions should fund training for their workers. In general, those surveyed did not find conflicts of interest in their relationship with the industry (AU)

Study protocol: assessing the association between corporate financial influence and implementation of policies to tackle commercial determinants of non-communicable diseases: a cross-sectional analysis of 172 countries.

INTRODUCTION: There are many case studies of corporations that have worked to undermine health policy implementation. It is unclear whether countries that are more exposed to corporate financial influence are systematically less likely to implement robust health policies that target firms' financial interests. We aim to assess the association between corporate financial influence and implementation of WHO-recommended policies to constrain sales, marketing and consumption of tobacco, alcohol and unhealthy foods. METHODS AND ANALYSIS: We will perform a cross-sectional analysis of 172 WHO Member States using national datasets from 2015, 2017 and 2020. We will use random effects generalised least squares regression to test the association between implementation status of 12 WHO-recommended tobacco, alcohol and diet policies, and corporate financial influence, a metric that combines disclosure of campaign donations, public campaign finance, corporate campaign donations, legislature corrupt activities, disclosure by politicians and executive oversight. We will control for GDP per capita, population aged >65 years (%), urbanisation (%), level of democracy, continent, ethno-linguistic fractionalisation, legal origin, UN-defined 'Small Island Developing States' and Muslim population (%) (to capture alcohol policy differences). We will include year dummies to address the possibility of a spurious relationship between the outcome variable and the independent variables of interests. For example, there may be an upward global trend in policy implementation that coincides with an upward global trend in the regulation of lobbying and campaign finance. ETHICS AND DISSEMINATION: As this study uses publicly available data, ethics approval is not required. The authors have no conflicts of interest to declare. Findings will be submitted to a peer-reviewed journal for publication in the academic literature. All data, code and syntax will be made publicly available on GitHub.

Conflict of Interests in the Scientific Production on Vitamin D and COVID-19: A Scoping Review.

The use of scientific evidence to support the process of formulating and implementing public policies might be biased by studies funded by the pharmaceutical and food industry, which more often than not meet corporate interests. This review aimed to analyze the occurrence of conflict of interest (COI) in academic production regarding vitamin D and COVID-19, considering the facility offered during the pandemic for academic publications of heterogeneous quality. A scoping review of observational studies published in Medline, Lilacs, and Google Scholar databases was carried out. The selected studies were published between December 2019 and August 2021, focused on the relationship between vitamin D and prevention or treatment of COVID-19 in non-institutionalized individuals, with no language restrictions. Twenty-nine studies met eligibility criteria. COI was disclosed in five papers and further identified by review authors in eight other papers, meaning COI was present in thirteen papers (44.8%). Studies were funded by companies in the diagnostics, pharmaceutical and food sectors. Conclusions favorable to vitamin D supplementation were more prevalent in papers where COI was identified (9/13, 69.2%) than among papers where COI was not found (4/16, 25.0%). Omissions of disclosure of COI, funding source, and sponsor functions were observed. The identification of possible corporate political activities in scientific papers about vitamin D published during the COVID-19 pandemic signals a need for greater transparency and guideline development on the prevention of COI in scientific production.

Disclosure of Pharmaceutical Industry Funding of Patient Organisations in Nordic Countries: Can Industry Self-Regulation Deliver on its Transparency Promise?

Pharmaceutical companies regularly fund patient organizations. It is important for patient organizations' credibility that there be transparency regarding this financial support. In Europe, the pharmaceutical industry promises to deliver transparency through self-regulation, as opposed to legally binding provisions, but self-regulation's effectiveness is contested. We compared the industry's transparency of funding in four Nordic countries that, given their general reputation for high transparency, offered a critical test of self-regulation's ability to deliver on its transparency promise. For 2017-2019, we compared: national rules regarding funding disclosure; disclosure practices as evidenced by the availability, accessibility, and format of company transparency reports; and disclosure data, including payment descriptions and sums. Transparency problems differed in kind and magnitude between countries. In Norway and Finland, unlike in Sweden and Denmark, data on funding were difficult to access and analyze and sometimes seemed incomplete or missing. We explain that a key factor allowing for country differences is the freedom given to a country's pharmaceutical industry trade associations to form self-regulatory rules, provided they do not fall below the weak, European-level minimum requirements. Transparency could be improved by aligning rules and practices with the FAIR data principles: that is, corporate disclosures should be findable, accessible, interoperable, and reusable.

Is It Possible to Solve the Conflicts Over Conflict of Interest? Comment on "Towards Preventing and Managing Conflict of Interest in Nutrition Policy? An Analysis of Submissions to a Consultation on a Draft WHO Tool".

Addressing conflicts of interest (COIs) when developing and implementing policies to address commercial determinants of health is pivotal to ensure that these policies are free from commercial and other vested interests of unhealthy commodities industry. As a concept, this is well accepted within the tobacco control community, and supported by the existence of an international treaty, the WHO Framework Convention on Tobacco Control (FCTC). But in nutrition policy the engagement of the food industry appears to remain controversial, as efforts to create partnerships are still underway. There is a need to undertake evaluation of existing COI policies to assess their implementation and outcomes, creating best practice models that can be replicated, and understanding how to change norms within governments. Additionally, a review of existing norms, codes of conduct, and ethics to determine their impact on preventing COI would guide future implementation of these measures. Finally, governments, academics, and advocates should consider how existing tools, guidelines or other instruments could help frame the COI discussion to ensure its political feasibility. There is a need for a discussion on whether the current approach of separate policies for distinct industries is preferable than a broader COI policy that would be applicable to a wide range of unhealthy commodities and across governmental sectors.

Disparities in industry funding among Colorectal Surgeons: a cross-sectional study.

BACKGROUND: Health Industry and physician collaboration generates innovation. Colorectal Surgeon (CRS) selection to collaborate might not be random. We aim to identify CRS personal and professional characteristics that facilitate collaboration with the Industry. METHOD: Cross-sectional study of Industry payments to CRS (2014-2018) using Open Payments Database from Centers for Medicare & Medicaid Services. Multivariable regression compared variables predicting payment amount including gender, years in practice, leadership positions, H-index, Twitter presence and geographic location. RESULTS: Surgeons who were male received 3.1 times the amount in Industry payments as compared to females (p = 0.014). Chairs and Division Chiefs received 2.7 times the amount in payments as compared to those without these leadership positions (p = 0.003). Surgeons with an H-index ≥ 8 received 2.2 times the amount in payments as compared to those with H-index < 8 (p = 0.001). Surgeons in practice for 12-19 and 20-30 years received 3 times and 4.4 times the amount in payments as compared to surgeons in practice for 1-11 years (p = 0.036 and p = 0.017, respectively). Surgeons in the South received 3.2 times and 2 times the amount in payments as compared to surgeons in the Northeast (p < 0.0005) and in the Midwest (p = 0.006). Surgeons with Twitter accounts received 1.7 times the amount in payments as compared to surgeons without Twitter (p = 0.036). Among Twitter users, those with 321-17,200 followers received 4.7 times and 9.5 times the amount in payments as compared to those with 0-15 and 16-79 followers, respectively (p = 0.008 and p = 0.009). CONCLUSION: Industry payments are more commonly addressed to male, senior surgeons in leadership tracks with strong social media outreach. With the increasing gender and racial variety in the CRS field, it is expected that collaborations between industry and surgeons will become more diverse and inclusive.

Sunshine on KOLs: assessment of the nature, extent and evolution of financial ties between the leaders of professional medical associations and the pharmaceutical industry in France from 2014 to 2019: a retrospective study.

OBJECTIVE: To investigate the financial relationships between key opinion leader (KOL) or non-KOL physicians and pharmaceutical and device companies in France. DESIGN: Retrospective and descriptive study. SETTING: All doctors practising in France, with a focus on 548 KOLs (board members of the professional medical associations that published guidelines in 2018-2019, identified on the associations' websites between 2018 and 2020). Ties were collected from the 'Transparency in Healthcare' database. MAIN OUTCOME MEASURES: The number and the value of gifts from 2014 to 2019, and of remunerations and contractual agreements from 2017 to 2019. RESULTS: KOLs represented 0.24% of the total number of physicians in France. The total value of gifts declared in the French database for all physicians amounted to €818M (US$936M, £741M). At least one gift was declared for 83% of KOLs. KOLs' gifts represented 0.68% of the total number of gifts to physicians and 1.5% of the total value of gifts, with a mean of €3700 per capita per year.The total value of contractual agreements declared for all physicians amounted to €125M. Contractual agreements involving the KOLs represented 0.72% of the number of contractual agreements with physicians and 2.5% of the value of the agreements, with a mean of €1900 per capita per year.A total of €156M in remunerations were declared for all physicians. KOL remunerations represented 2.3% of the number of physician remunerations and 4.4% of the total value of the remunerations paid to physicians, with a mean of €4100 per capita per year.Almost all professional medical associations (99%) had at least one KOL in their board with a financial tie to the industry, but the amount varied widely among the associations. CONCLUSION: Financial relationships between KOLs and the industry in France are extensive. KOLs have much more financial ties than non-KOL practitioners.