Financial conflicts of interest among authors of clinical practice guideline for diabetes mellitus in Japan between 2016 and 2020

doi:10.21203/rs.3.rs-3396067/v1

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Financial conflicts of interest among authors of clinical practice guideline for diabetes mellitus in Japan between 2016 and 2020

https://doi.org/10.21203/rs.3.rs-3396067/v1

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Aims:

To assess the financial relationships between pharmaceutical companies and authors of the Japanese Clinical Practice Guideline for Diabetes 2019.

Methods:

Retrospective analysis of publicly available pharmaceutical-industry personal payments evaluated size and prevalence of financial relationships between all 27 authors of the CPG and pharmaceutical companies in Japan. Personal payments from pharmaceutical companies to the authors between 2016 and 2020 were extracted from publicly disclosed database and each pharmaceutical company.

Results:

Of all 135 authors of clinical practice guideline for diabetes mellitus developed by the Japan Diabetes Society in 2019, 129 (95.6%) received personal payments from pharmaceutical companies between 2016 and 2020. The total amounts of personal payments were $23,130,423, with a median of $89,955 and an average of $171,336 per author. More than 74.1% (100 authors), 60.7% (82 authors), and 47.4% (64 authors) received more than $10,000, $50,000, and $100,000 personal payments in total over the five years, respectively. The guideline chairpersons of the guideline development and review committees received substantial amounts of personal payments from the companies during the guideline development period.

Conclusion:

Nearly all guideline authors received substantial amounts of personal payments from pharmaceutical companies during the guideline development period and one year after its publication. Nevertheless, the Japan Diabetes Society roughly managed their COIs, and many authors self-declared no financial COIs with pharmaceutical companies even though they received moderate amounts of personal payments. These findings underscore the urgent need for policy interventions to enhance transparency, integrity, and reliability in the development of clinical practice guidelines in Japan.

Health Policy

Conflicts of interest

pharmaceutical companies

clinical practice guideline

health policy

evidence-based medicine

diabetes

ethics

Clinical practice guidelines (CPGs) serve as pivotal frameworks for standardizing evidence-based diagnostic and therapeutic approaches, particularly in the management of diabetes and beyond.^1,2 However, the integrity of these guidelines can be compromised by conflicts of interest (COIs).^3–5 Over the last two decades, increased attention has been paid to the financial relationships between CPG authors and the healthcare industry worldwide.^6–13 Not all but some financial ties with the healthcare industry have the potential to bias CPG recommendations, which could have harmful effects on patient care.^5,14 To address this issue, various national and international professional organizations have implemented stringent COI management strategies.^15–18 Given the significant influence of CPGs on patients, healthcare professionals, and other stakeholders, rigorous COI management—including full disclosure of COIs, efforts to minimize COIs among CPG authors and organizations, and assignment of COI-free CPG chairs—is essential for establishing trustworthy CPGs and promoting patient-centered care.^15,16,18,19

The fields of diabetology and endocrinology have garnered significant attention from pharmaceutical companies due to the escalating prevalence of diabetes and obesity, as well as the advent of novel drugs. Previous research has indicated that endocrinologists in the United States have received disproportionately higher personal payments from pharmaceutical companies compared to other specialists.²⁰ In this context, it becomes crucial for authors of CPGs in diabetes to properly manage and transparently disclose their financial relationships with pharmaceutical companies. Despite the critical nature of this issue, no research has investigated these financial relationships in the Japanese context. The present study aims to fill this research gap by assessing the size and prevalence of financial relationships between pharmaceutical companies and CPG authors for diabetes in Japan, utilizing publicly disclosed payment data.

Study setting & participants

This cross-sectional retrospective study examined size and prevalence of personal payments made to all authors for Japanese Clinical Practice Guideline for Diabetes 2019 (JCPGD) developed by the Japan Diabetes Society in 2019,²¹ using payment data disclosed by pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association. The author list and JCPGD main text was available from the Japan Diabetes Society webpage as of September 2023. Although the Japan Diabetes Society published both Japanese and English version of the JCPGD,²¹ this study focused solely on the Japanese version, which is intended for distribution to Japanese physicians for guiding their diabetes care practices.

Data collection & payment source

Data on author names, gender, affiliations, and positions were extracted from the JCPGD and associated official institutional webpages. Additionally, individual authors' COI statements were obtained from the JCPGD. All pharmaceutical companies affiliated with the Japan Pharmaceutical Manufacturers Association disclose their payment data concerning lecturing, writing, and consulting at the individual physician level, as previously noted.^11,22,23 However, these companies update their payment data annually and remove data from previous years. Therefore, payment data for the JCPGD authors between 2016 and 2019 were extracted from a publicly accessible payment database developed by the Medical Governance Research Institute.²⁴ Payments to the JCPGD authors in 2020 were collected directly from each affiliated pharmaceutical company's webpage. As the JCPGD was published in 2019, this study collected payments for three years before (2016–2018), the publication year (2019), and one year after its publication (2020). Additionally, the number of publications and h-index of the JCPGD authors were collected from the Scopus database, as previously described.^18,25

Data analysis

Descriptive analysis was performed on the demographic and payment data collected from the companies between 2016 and 2020. To examine associations between the authors' demographic characteristics and payment amounts, this study conducted a robust-adjusted negative binomial regression, as the payment distribution was highly skewed. Predictor variables included authors' gender, affiliation & position at their affiliations, type of involvement in guideline development, and the number of h-index, while the outcome variable was the total payment amounts per author. Payment values were converted from Japanese yen to U.S. dollars using the 2020 average monthly exchange rates of 106.8 yen per $1. Data extraction and analyses were performed with Python 3.9.12 (Python Software Foundation, Beaverton, OR, USA), Microsoft Excel, version 16.0 (Microsoft Corp., Redmond, WA, USA), and Stata version 17.0 (StataCorp, College Station, TX, USA).

Ethical clearance

As this study was a retrospective analysis of publicly available data and met the definition of non-human subjects research, no institutional board review and approval were required. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline.

Declaration of generative AI in scientific writing

During the preparation of this work, the author used ChatGPT version 4.0 to check and correct grammatical and spelling errors. After using this tool, the author carefully reviewed and edited the content as needed and takes full responsibility for the content of the publication.

Demographic characteristics of the JCPGD authors are described in Table 1. Among the 135 JCPGD authors, 125 (92.6%) were male, 102 (75.6%) were affiliated with universities or university teaching hospitals, 67 (49.6%) were university professors, and 102 (66.7%) specialized in diabetes, endocrinology and metabolism. However, there was no statement indicating that patients with diabetes mellitus were involved in the JCPGD development. The mean number of academic publications and h-index were 171.8 (standard deviation: 155.6) and 32.1 (SD: 21.8), indicating the very high academic achievement of the JCPGD authors.

Table 1

Demographic characteristics of authors of Japanese Clinical Practice Guideline for Diabetes 2019
Variables	N = 135
Gender, n (%)
Male	125 (92.6)
Female	10 (7.4)
Affiliation, n (%)
University and university teaching hospitals	102 (75.6)
Professor	67 (49.6)
Other positions including associate professors, assistant professors, and lecturers	35 (25.9)
Other general hospitals	33 (24.4)
Specialty
Diabetes, endocrinology, and metabolism	102 (75.6)
Pediatrics	5 (3.7)
Epidemiology, public health, and methodology	5 (3.7)
Dentistry	4 (3.0)
Ophthalmology	3 (2.2)
Obstetrics and gynecology	2 (1.5)
Other specialties	14 (10.4)
Academic performance, No.
Mean h-index (standard deviation)	32.1 (21.8)
Mean number of publications (standard deviation)	171.8 (155.6)

Table 2 shows the personal payments from pharmaceutical companies to the JCPGD authors between 2016 and 2020. Of all 135 JCPGD authors, 129 (95.6%) received at least one personal payment for lecturing, consulting services, and writing from the pharmaceutical companies over the five years. A total of 19,755 payments, amounting to $23,130,423, were made to the JCPGD authors by the pharmaceutical companies over the five years. Lecturing payments and consulting payments accounted for 84.2% ($19,478,763) and 9.8% ($380,217) of total amounts of the personal payments over the five years. The median and mean payments per author were $89,955 (interquartile range [IQR]: $7,954‒$258,527) and $171,336 (SD: $220,502), respectively. More than 74.1% (100 authors), 60.7% (82 authors), and 47.4% (64 authors) received more than $10,000, $50,000, and $100,000 in total payments over the five years, respectively.

Table 2

Summary of personal payments from pharmaceutical companies to the authors of Japanese Clinical Practice Guideline for Diabetes 2019
Variables	2016	2017	2018	2019	2020	Value
Total amount of payments, $	5,159,566	5,329,700	4,864,444	4,749,531	3,027,182	23,130,423
Mean payments per author (standard deviation), $	38,219 (50,263)	39,479 (50,816)	36,033 (47,588)	35,182 (46,624)	22,424 (33,331)	171,336 (220,502)
Median payments per author (interquartile range), $	15,478 (1,598–60,908)	19,501 (1,251–57,136)	15,821 (2,271–53,604)	15,802 (1,284–52,045)	7,571 (546–32,581)	89,955 (7,954‒258,527)
Range, $	0–271,491	0–232,162	0–245,168	0–216,321	0–210,167	0‒1,087,444
Authors with payments, n (%)
Any payments	120 (88.9)	117 (86.7)	115 (85.2)	119 (88.2)	106 (78.5)	129 (95.6)
>$10,000	79 (58.5)	82 (60.7)	82 (60.7)	77 (57.0)	63 (46.7)	100 (74.1)
>$50,000	38 (28.2)	41 (30.4)	37 (27.4)	35 (35.9)	23 (17.0)	82 (60.7)
>$100,000	15 (11.1)	15 (11.1)	11 (8.2)	13 (9.6)	3 (2.2)	64 (47.4)
>$250,000	1 (0.7)	0 (0)	0 (0)	0 (0)	0 (0)	36 (26.7)
>$500,000	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	12 (8.9)
Japanese yen (¥) were converted to US dollars ($) using the 2020 average monthly exchange rate of ¥106.8 per $1.

Table 3

Associations between authors’ demographic characteristics and payment amounts
Variables	Relative monetary value (95% confidence interval)	P value
Gender
Female	Reference
Male	2.67 (0.94–7.56)	0.06
Affiliation and position
Non-university professors	Reference
University professors	3.91 (2.00–7.65)	< 0.001
Other physicians and healthcare professionals	1.39 (0.66–2.92)	0.39
Specialty
Other clinical specialties	Reference
Diabetes, endocrinology, and metabolism	1.99 (1.12–3.56)	0.02
Epidemiology and public health	0.23 (0.09–0.60)	0.003
Type of involvement
Guideline development committee authors	Reference
Review committee authors	0.67 (0.39–1.14)	0.14
Guideline development supporting authors	0.70 (0.41–1.20)	0.20
H-index	1.02 (1.01–1.04)	< 0.001

Regarding yearly breakdown of personal payments, there were no general trends in the number of authors receiving payments and mean payment amounts between 2016 and 2019 (Table 2), while the number of authors receiving payments and mean payments decreased in 2020 compared to those between 2016 and 2019. One hundred six (78.5%) to one hundred twenty (88.9%) authors received one or more payments each year. The majority of the authors annually received more than $10,000 personal payments. Between 2016 and 2018, 128 (94.8%) JCPGD authors received personal payments totaling $15,353,710 from the companies. The median payment amounts were $49,382 (IQR: $6,767–$169,817). The chairperson of JCPGD development committee received a total of $207,889 personal payments over the three years. Similarly, the chairperson of the JCPGD development committee received $207,889 in personal payments over the three years.

The multiple negative binomial regression showed that university professor authors received 3.91 times larger personal payments (95% confidence interval [CI]: 2.00–7.65, p < 0.001) than non-professor authors. Authors specializing in diabetes, endocrinology, and metabolism received 1.99 times larger personal payments (95% CI: 1.12–3.56, p = 0.02) than those in other clinical specialties. Furthermore, a higher h-index was significantly associated with larger personal payments (relative monetary value: 1.02 [95% CI: 1.01–1.04], p < 0.001). There were no significant associations between payment amounts and gender or type of involvement.

Of 135 authors, 80 (59.3%) self-declared financial COIs with one or more companies between 2016 and 2018. However, the Japan Diabetes Society allowed the CPG authors to omit declaring financial COIs below a certain monetary threshold (e.g., 500,000 Japanese yen, equivalent to $4,683, or more per year per company for lecturing, honoraria, and writing compensations; 1,000,000 Japanese yen, equivalent to $9,363, or more per year per company for consulting services, royalties, ownership interests, grants, and research funding). Consequently, 55 (40.7%) authors declared no financial conflicts of interest with healthcare companies between 2016 and 2018, although 87.2% (48 out of 55) of these authors received at least some personal payments during the declaration period (2016–2018).

This cross-sectional study examined the size and prevalence of financial conflicts of interest among authors of the Japanese Clinical Practice Guideline for Diabetes 2019. To the best of the author's knowledge, this is the first study to evaluate the prevalence and magnitude of financial relationships between CPG authors and pharmaceutical companies in Japan in the field of diabetology and endocrinology. Surprisingly, more than 95% of the JCPGD authors received more than $23.1 million in personal payments for lecturing, consulting, and writing compensations from pharmaceutical companies. Furthermore, the JCPGD chairpersons received these payments during the guideline development period. These findings raise scientifical and ethical concerns about the JCPGD.

Limitations

This study has several limitations. The cross-sectional design precludes longitudinal analysis, and the focus on a single set of guidelines may not be generalizable to other fields or countries. The payment data were extracted from a secondary database maintained by a non-profit research organization, Medical Governance Research Institute, which includes nearly all personal payment data collected from each pharmaceutical company belonging to the Japan Pharmaceutical Manufacturers Association between 2016 and 2019. However, there are no legal regulations requiring pharmaceutical companies to accurately disclose their payments to physicians in Japan.²⁶ Therefore, this study could not exclude the possibility of errors or misreporting in the payment data disclosed by the companies. Additionally, as the payment data were only voluntarily disclosed by companies belonging to the Japan Pharmaceutical Manufacturers Association, there could be financial relationships between the JCPGD authors and undisclosed pharmaceutical companies.

Interpretation and policy and clinical implications

The high proportion of authors receiving personal payments in this study is consistent with many previous studies conducted in Japan. For example, the proportion of CPG authors receiving personal payments in Japan was 87.0% in infectious diseases,¹² 88% in nephrology,¹⁸ 88.2% in gastroenterology,¹¹ 88.6% in urology,²⁷ 90.6% in dermatology,²⁸ 94.6% in hematology,²⁹ 96.3% in otolaryngology,²⁵ and 100% in hepatology²² and esophageal cancer.¹³

However, compared to previous studies conducted in other countries, this study indicated that the JCPGD authors had much stronger financial ties to the pharmaceutical companies. Previous research reported that 48.0% of authors of the 2021 Standards of Medical Care in Diabetes developed by the American Diabetes Association received any payments from pharmaceutical and medical device companies during the three years prior to the CPG publication in the United States.³⁰ Irwig et al. found that 74% of authors of the Endocrine Society Clinical Practice Guidelines received personal payments from the healthcare industry in the United States between 2013 and 2016.³¹ Additionally, the median personal payments to the Endocrine Society CPG authors were $2,581 in the four-year combined amounts, which was much lower than those to the JCPGD authors.³¹

Additionally, this study demonstrated that the JCPGD chairpersons received substantial amounts of payments, and the Japan Diabetes Society allowed the JCPGD authors to omit declaring certain amounts of payments, such as about $4,683 per company per year for lecturing and writing payments and $9,363 for consulting payments. The high percentage of JCPGD authors with financial ties to pharmaceutical companies, the chairpersons' receipt of personal payments, and limited COI declarations are clear deviations from global COI management guidelines. The U.S. National Academy of Medicine, formerly known as the Institute of Medicine, has set several strong recommendations concerning financial conflicts of interest (COIs) in the CPG development. The Academy advises that the majority of CPG authors should not have financial COIs with the pharmaceutical industry. Additionally, it is imperative that the chairperson overseeing the CPG development be free from any financial COIs with the industry. Furthermore, all CPG authors are expected to fully disclose their financial COIs, irrespective of the monetary value involved.¹ Similarly, the Guidelines International Network published nine principles that echo these sentiments. Among these principles are the exclusion of the majority of CPG authors with COIs, the appointment of a COI-free chair for the CPG, and the full disclosure of all financial COIs regardless of the amount involved.¹⁶ In 2013, the Guideline Panel Review working group published a standard guideline in the British Medical Journal (BMJ) that addresses situations where substantial skepticism about the CPG may arise.¹⁵ According to this guideline, red flags that should raise concerns include a CPG chairperson with COIs, the absence of patient representatives or community stakeholders in the CPG development process, and the majority of CPG authors having financial COIs.

In contrast, this study found that the Japan Diabetes Society has set high monetary thresholds for financial COI declarations, allowing CPG authors to omit declaring financial COIs below a certain payment amount. This practice has led to significant under-reporting and non-disclosure of financial relationships between the JCPGD authors and pharmaceutical companies. This unrecommended approach to setting high monetary thresholds for financial COI declaration is not unique to the Japan Diabetes Society; other medical societies in Japan, such as the Japanese Society of Gastroenterology¹¹ and Japanese Society of Nephrology¹⁸, have also adopted similar policies. Indeed, a majority of medical societies developing CPGs require their CPG authors to fully disclose financial COIs with the healthcare industry. A study by Brems et al. found that only 6% of medical societies worldwide that produce CPGs had a specific monetary threshold for financial COI declaration as of 2021.¹⁷ Moreover, a literature review of COI policies conducted by the U.S. Preventive Services Task Force revealed that among U.S. medical organizations producing CPGs, the Task Force itself set the highest financial threshold of $10,000 in integrated annual COI, not calculated per item or company in 2017.³² Considering these previous findings, this study highlights the urgent need for substantial improvement in COI management strategies among CPG authors in Japan in the field of diabetology and endocrinology.

Nearly all the authors of the Japanese Clinical Practice Guideline for Diabetes 2019 developed by the Japan Diabetes Society received personal payments from pharmaceutical companies during the CPG development and one year after its publication. These findings call for immediate policy interventions to enhance the transparency, integrity, and reliability of clinical practice guidelines for diabetes care in Japan.

Conflicts of interest:

The authors declare that there were no conflicts of interest for this study.

Funding sources:

The authors declare that there were no funding sources for this study.

Data availability statement:

All data used in this study is available from the Japan Diabetes Society (http://www.jds.or.jp/modules/publication/index.php?content_id=4), Yen For Docs database maintained by Medical Governance Research Institute (https://yenfordocs.jp/), and each pharmaceutical companies belonging to the Japan Pharmaceutical Manufacturers Association.

Acknowledgments

The authors appreciate Ms Megumi Aizawa for her dedicated support of my research project.

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Version 1

posted

You are reading this latest preprint version

Financial conflicts of interest among authors of clinical practice guideline for diabetes mellitus in Japan between 2016 and 2020

Status:

Version 1

Abstract

Aims:

Methods:

Results:

Conclusion:

Introduction

Methods

Study setting & participants

Data collection & payment source

Data analysis

Ethical clearance

Declaration of generative AI in scientific writing

Results

Discussion

Limitations

Interpretation and policy and clinical implications

Conclusions

Declarations

References

Status:

Version 1