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Japan's conditional early approval program for innovative cancer drugs: Comparison of the regulatory processes with the US FDA and the EMA

Murayama A, Ueda M, Shrestha S, Tanimoto T, Ozaki A

Cancer Cell, 2021 09 13;39(9):1165-1166.
PMID: 34358449 DOI: 10.1016/j.ccell.2021.07.008
Japan's valsartan clinical trials shambles; time for fundamental changes

Ozaki A, Harada K, Murayama A, Saito H, Sawano T, Tanimoto T, et al.

Int J Health Plann Manage, 2023 Feb 16.
PMID: 36794862 DOI: 10.1002/hpm.3618

Japan's Diovan® /valsartan 'scandal' has received sensational coverage in the nation's media since 2012. Publication of fraudulent research and their subsequent retraction boosted and then curtailed the use of what was a useful therapeutic drug. Some authors of the papers resigned, others disputed the retractions and resorted to legal counsel to protect themselves. One individual, an undeclared Novartis employee involved in the research, was arrested. A complex and virtually unwinnable case was brought against him and Novartis, claiming that data alteration amounted to false advertising, but lengthy criminal court cases resulted in the case failing. Unfortunately, key elements, including conflicts of interest, pharmaceutical company interference in trials of its product, and the role of the institutions involved, have been effectively ignored. The incident also emphasised the fact that Japan's unique society and approach to science does not conform well to international standards. Although the supposed impropriety caused the appearance of a new Clinical Trials Act in 2018, the law has been criticized for being ineffectual and simply increasing clinical trial bureaucracy. This article examines the 'scandal' and identifies where changes must be made to clinical research and the roles of the various stakeholders in Japan to increase public trust in clinical trials and biomedical publications.
Fulltext Limited capacity of SARS-CoV-2 variants testing in Japan: A secondary analysis using publicly available data

Hashimoto T, Ozaki A, Bhandari D, Sawano T, Murayama A, Shrestha S, et al.

Travel Med Infect Dis, 2021;43:102145.
PMID: 34298174 DOI: 10.1016/j.tmaid.2021.102145
Fulltext Observational study of financial and non-financial conflicts of interest among the Japanese government advisory board members concerning coronavirus disease 2019

Mamada H, Murayama A, Ozaki A, Hashimoto T, Saito H, Sawano T, et al.

Medicine (Baltimore), 2023 Jan 27;102(4):e32776.
PMID: 36705373 DOI: 10.1097/MD.0000000000032776

This cross-sectional analysis aimed to assess the extent of conflicts of interest among the Japanese government coronavirus disease 2019 (COVID-19) advisory board members and elucidate the accuracy of conflicts of interest (COI) disclosure and management strategies. Using the payment data from all 79 pharmaceutical companies in Japan between 2017 and 2019 and direct research grants from the Japanese government between 2019 and 2020, we evaluated the extent of financial and non-financial COI among all 20 Japanese government COVID-19 advisory board members. The Ethic Committee of the Medical Governance Research Institute approved this study. Japanese government COVID-19 advisory board members were predominantly male (75.0%) and physicians (50.0%). Between 2019 and 2020, 2 members (10.0%) received a total of $819,244 in government research funding. Another 5 members (25.0%) received $532,127 in payments, including $276,722 in personal fees, from 31 pharmaceutical companies between 2017 and 2019. The average value of the pharmaceutical payments was $9155 (standard deviation: $12,975). Furthermore, neither the Ministry of Health, Labor, and Welfare nor the Japanese Cabinet Secretariat disclosed financial or non-financial COI with industry. Additionally, the government had no policies for managing COI among advisory board members. This study found that the Japanese government COVID-19 advisory board had financial and non-financial COI with pharmaceutical companies and the government. Furthermore, personal communication received as part of this research indicated that there were no rigorous COI management strategies for the COVID-19 advisory board members. Any government must ensure the independence of scientific advisory boards by implementing more rigorous and transparent management strategies that require the declaration and public disclosure of all COI.
Pharmaceutical Payments to Japanese Board-Certified Head and Neck Surgeons Between 2016 and 2019

Murayama A, Shigeta H, Kamamoto S, Yamashita E, Saito H, Sawano T, et al.

OTO Open, 2023;7(1):e31.
PMID: 36998569 DOI: 10.1002/oto2.31

OBJECTIVE: To evaluate the magnitude, prevalence, and trend of the financial relationship between Japanese head and neck surgeons and pharmaceutical companies between 2016 and 2019.
STUDY DESIGN: Cross-sectional analysis.
SETTING: Japan.
METHODS: This study evaluated personal payments concerning lecturing, consulting, and writing paid by 92 major pharmaceutical companies to all Japanese head and neck surgeons board-certified by the Japan Society for Head and Neck Surgery between 2016 and 2019. The payments were descriptively analyzed and payment trend were assessed using population-averaged generalized estimating equations. Further, the payments to board executive board members with specialist certification were also evaluated separately.
RESULTS: Of all 443 board-certified head and neck surgeons in Japan, 365 (82.4%) received an average of $6443 (standard deviation: $12,875), while median payments were $2002 (interquartile ranges [IQR] $792-$4802). Executive board specialists with a voting right received much higher personal payments (median $26,013, IQR $12,747-$35,750) than the non-executive specialists (median $1926, IQR $765‒$4134, p
Fulltext Evaluation of Conflicts of Interest among Participants of the Japanese Nephrology Clinical Practice Guideline

Murayama A, Yamada K, Yoshida M, Kaneda Y, Saito H, Sawano T, et al.

Clin J Am Soc Nephrol, 2022 Jun;17(6):819-826.
PMID: 35623883 DOI: 10.2215/CJN.14661121

BACKGROUND AND OBJECTIVES: Rigorous and transparent management strategies for conflicts of interest and clinical practice guidelines with the best available evidence are necessary for the development of nephrology guidelines. However, there was no study assessing financial and nonfinancial conflicts of interest, quality of evidence underlying the Japanese guidelines for CKD, and conflict of interest policies for guideline development.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This cross-sectional study examined financial and nonfinancial conflicts of interest among all 142 authors of CKD guidelines issued by the Japanese Society of Nephrology using a personal payment database from all 92 major Japanese pharmaceutical companies between 2016 and 2019 and self-citations by guideline authors. Also, the quality of evidence and strength of recommendations underlying the guidelines and conflicts of interest policies of Japanese, US, and European nephrology societies were evaluated.
RESULTS: Among 142 authors, 125 authors (88%) received $6,742,889 in personal payments from 56 pharmaceutical companies between 2016 and 2019. Four-year combined median payment per author was $8258 (interquartile range, $2230‒$51,617). The amounts of payments and proportion of guideline authors with payments remained stable during and after guideline development. The chairperson, vice chairperson, and group leaders received higher personal payments than other guideline authors. Of 861 references in the guidelines, 69 (8%) references were self-cited by the guideline authors, and 76% of the recommendations were on the basis of low or very low quality of evidence. There were no fully rigorous and transparent conflicts of interest policies for nephrology guideline authors in the United States, Europe, and Japan.
CONCLUSIONS: Most of the Japanese CKD guideline recommendations were on the basis of low quality of evidence by the guideline authors tied with pharmaceutical companies, suggesting the need for better financial conflicts of interest management.
Fulltext Nature and Trends in Personal Payments Made to the Respiratory Physicians by Pharmaceutical Companies in Japan between 2016 and 2019

Murayama A, Hoshi M, Saito H, Kamamoto S, Tanaka M, Kawashima M, et al.

Respiration, 2022;101(12):1088-1098.
PMID: 36353778 DOI: 10.1159/000526576

BACKGROUND: Financial relationships between healthcare professionals and pharmaceutical companies have historically caused conflicts of interest and unduly influenced patient care. However, little was known about such relationship and its effect in clinical practice among specialists in respiratory medicine.
METHODS: Based on the retrospective analysis of payment data made available by all 92 pharmaceutical companies in Japan, this study evaluated the magnitude and trend of financial relationships between all board-certified Japanese respiratory specialists and pharmaceutical companies between 2016 and 2019. Magnitude and prevalence of payments for specialists were analyzed descriptively. The payment trends were assessed using the generalized estimating equations for the payment per specialist and the number of specialists with payments.
RESULTS: Among all 7,114 respiratory specialists certified as of August 2021, 4,413 (62.0%) received a total of USD 53,547,391 and 74,195 counts from 72 (78.3%) pharmaceutical companies between 2016 and 2019. The median (interquartile range) 4-year combined payment values per specialist were USD 2,210 (USD 715-8,178). At maximum, one specialist received USD 495,332 personal payments over the 4 years. Both payments per specialist and number of specialists with payments significantly increased during the 4-year period, with 7.8% (95% CI: 5.5-9.8; p < 0.001) in payments and 1.5% (95% CI: 0.61-2.4; p = 0.001) in number of specialists with payments, respectively.
CONCLUSION: The majority of respiratory specialists had increasingly received more personal payments from pharmaceutical companies for the reimbursement of lecturing, consulting, and writing between 2016 and 2019. These increasing financial relationships with pharmaceutical companies might cause conflicts of interest among respiratory physicians.