Characteristics of Japanese physician influencers on Twitter during the COVID-19 pandemic and fact-checking their tweets on COVID-19-related drugs.

BACKGROUND: During the coronavirus disease-2019 (COVID-19) pandemic, segments of the public relied on social media platforms such as Twitter for medical information shared by medical personnel. Although physicians are likely to disseminate more accurate information on Twitter than non-medical individuals, it cannot be taken for granted. As such, tweets written by physicians in Japan should also be scrutinized for accuracy. PURPOSE: The purpose of this study was to create a profile of the most popular physician influencers on Twitter in Japan, and to do a fact-check of their tweets regarding COVID-19-related drugs. DESIGN: This is a retrospective observational study. METHODS: We purchased Twitter data for Japan for the initial 9 months of the COVID-19 pandemic (from January 2020 to September 2020), and extracted tweets with keywords related to COVID-19 at a sampling rate of 3%. The most popular physicians were identified and selected consecutively by searching for the top 1000 accounts using Twitter's search function. These top accounts were considered influencers and their tweets and retweets concerning COVID-19-related drugs were fact-checked against scientific literature. RESULTS: We identified 21 physician influencers with real names: most were male in their 40s and 50s working at private medical facilities. The contents of their tweets were mainly sourced from scientific publications that were current at that time. The fact-check revealed that only one of 50 tweets was not correct while the others had no identifiable inaccuracies. CONCLUSIONS: Except for one tweet, tweets written and retweeted by Japanese physician influencers concerning the COVID-19-related drugs contained predominantly accurate information.

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

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

Evaluation of non-research payments from pharmaceutical companies to urologists in Japan between 2016 and 2019.

OBJECTIVE: To evaluate the magnitude and trends in personal payments from pharmaceutical companies to urologists in Japan. METHODS: This cross-sectional study examined the personal payments made to urologists by the major pharmaceutical companies in Japan between 2016 and 2019. Descriptive analyses were performed on the payment data. All urologists board-certified by the Japanese Urological Association as of March 2022 were included in this study. Trends in personal payments were assessed using the population-averaged generalized estimating equations with panel data of per-physician personal payments. RESULTS: Among 7016 active board-certified urologists, 4962 (70.7%) accepted 53,070 payments totaling $36,424,239 for reimbursement of lecturing, writing, and consulting compensations from 66 pharmaceutical companies between 2016 and 2019. The median payments per urologist receiving payments were $1714 [interquartile range(IQR): $700-$4583] in payment amounts and 4.0 (IQR: 2.0-10.0) in the number of payments. Only 1%, 5%, 10%, and 25% of top-paid urologists accepted 36.2%, 64.8%, 75.8%, and 90.1% of overall payments respectively. The payments per urologist and the number of payment contracts had annually increased over this period by 4.1% (95% CI: 2.3%-6.0%, p < 0.001) and 2.4% (95% CI: 1.2%-3.7%, p < 0.001), but there was no significant change in the number of urologists receiving payments, with a relative average annual change of 0.7% (95% CI: -0.15%-1.6%, p = 0.10) between 2016 and 2019. CONCLUSION: Most urologists received personal payments for lecturing, consulting, and writing compensations from pharmaceutical companies in Japan. The payments from pharmaceutical companies had been increasing over the 4-year period. These payments were substantially concentrated on a small number of urologists.

Japan's valsartan clinical trials shambles; time for fundamental changes.

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.

Possibility for Children with Medical Complexities to Reach a 3000-m Peak: A Report of 2 Cases.

With the recent development of neonatal medicine, the number of children with medical complexities (CMCs) is increasing. Outdoor activities are important for their psychosocial development, and the principles of accessibility should be addressed. We report the experience of 2 CMCs' high-altitude mountaineering with the necessary support. The participants were a 3-y-old girl with cerebral palsy, symptomatic epilepsy, and a ventriculoperitoneal shunt (Child A) and a 6-y-old girl who underwent bilateral Glenn operations at 11 mo for hypoplastic left heart syndrome (Child B). The support staff consisted of 4 doctors, 1 nurse, 5 nonmedical staff , 3 members from a mountaineering association, and 2 people from an oxygen company. The climbing schedule was 2 days. On the first day, we took a bus to a hut at an altitude of 2450 m and stayed overnight to acclimatize to the altitude. On the second day, we took the beginner's route, which took 3 h to climb 500 m, and our team made an attempt on the summit. During the attempt, Child B panicked. Although her lung sounds did not raise suspicions of pulmonary edema, we decided to leave the mountain with her because her transcutaneous oxygen saturation decreased. Child A had no apparent health problems and made it to the summit. Although CMCs' alpine climbing requires careful planning and staffing considering the risk of high-altitude sickness, our case suggests the feasibility of such activities with CMCs as part of accessibility.

Financial Relationships Between Pharmaceutical Companies and Rheumatologists in Japan Between 2016 and 2019.

BACKGROUNDS: Given the increasing number of novel and expensive drugs for rheumatoid diseases, the financial relationships between pharmaceutical companies and rheumatologists could be prevalent and substantial. However, little was known about the information in Japan. METHODS: Using payment data publicly disclosed by 92 major pharmaceutical companies, we evaluated the financial relationships between pharmaceutical companies and rheumatologists who were board certified by the Japan College of Rheumatology between 2016 and 2019. The trends in payments were estimated by the generalized estimating equations with 4-year payment data. Differences in payments between general and leading rheumatologists including the board members, clinical practice guideline authors, and medical journal editors were assessed. RESULTS: Of the board-certified rheumatologists, 70.7% (3563 of 5038) received a total of $55,246,485 in personal payments for lecturing, writing, and consulting from 79 pharmaceutical companies between 2016 and 2019. The median payments per rheumatologist receiving payments were $3447 (interquartile range, $1124-$11,974) in payment amounts. There were increasing trends in the payments per rheumatologist and the number of rheumatologists with payments, with average yearly change rates of 5.9% (95% confidence interval, 3.9%-7.9%; p < 0.001) and 1.2% (95% CI, 0.3%-2.0%; p = 0.008). The leading rheumatologists such as the society board members, clinical practice guideline authors, and medical journal editors received much more payments than other rheumatologists. CONCLUSION: Most rheumatologists increasingly received personal payments for lecturing, consulting, and writing reimbursements from pharmaceutical companies in Japan. These payments were significantly concentrated on rheumatologists in authoritative and influential positions.

Telepathology in intraoperative frozen section consultation of breast cancer sentinel node biopsy in Fukushima, Japan following the 2011 triple disaster: diagnostic accuracy and required time during the early implementation phase.

In breast cancer surgery, some medical facilities lack the necessary resources to conduct sentinel lymph node biopsy and its intraoperative frozen section consultation. In the coastal rural area of Fukushima, Japan, which has suffered from physician undersupply following the 2011 triple disaster of earthquake, tsunami and nuclear disaster, we explored the feasibility of telepathology by evaluating the diagnostic accuracy in remote intraoperative frozen section consultation of sentinel lymph node biopsy and its required time. Although examination time has room for improvement, telepathology can be one possible solution in resource-limited areas.

A longitudinal study of mental health in healthcare workers in Japan during the initial phase of COVID-19 pandemic: comparison with the general population.

The COVID-19 pandemic negatively impacted the mental health of people in Japan. Healthcare workers (HCWs) especially suffered from poor mental health, engaging with COVID-19 patients while protecting themselves from infection. However, a long-term assessment of their mental health in comparison to the general population remains to be conducted. This study evaluated and compared changes in mental health between these two populations over a six-month period. Measures of mental health, loneliness, hope and self-compassion were completed at baseline and at six-month follow-up. Two-way MANOVA (Time x Group) identified that no interaction effects were present. However, at baseline, HCWs had higher levels of mental health problems and loneliness, and lower levels of hope and self-compassion than the general population. Furthermore, a higher level of loneliness was found in HCWs at six months. These findings highlight strong feelings of loneliness in HCWs in Japan. Interventions such as digital social prescribing are recommended.

Evaluation of financial relationships between Japanese certified pediatric hematologist/oncologists and pharmaceutical companies: a cross-sectional analysis of personal payments from pharmaceutical companies between 2016 and 2019.

This cross-sectional study evaluated the magnitude of personal payments made by pharmaceutical companies to pediatric hematologist-oncologists (PHOs) board-certified by the Japanese Society of Pediatric Hematology/Oncology (JSPHO), using publicly disclosed data. Among all 307 PHOs, 215 (70.0%) PHOs received $916 703 personal payments from 54 pharmaceutical companies between 2016 and 2019 in total. Median four-year payments per PHO was $1440 (interquartile range, $523-$4015). Payments per PHO significantly increased during the study period, by 23.8% (95% confidence interval: 15.3%-32.8%, P < 0.001) annually. Furthermore, leading PHOs, including university professors, society board members, and clinical practice guideline authors, received far larger personal payments from the companies.

Nature and Trends in Personal Payments Made to the Respiratory Physicians by Pharmaceutical Companies in Japan between 2016 and 2019.

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.

A critical appraisal of Japan's new drug approval process: a case study of FLT3-ITD inhibitor quizartinib.

In the last two decades, simultaneous global development of novel drugs become more common by conducting multiregional clinical trials. However, regulatory authorities of different regions often make different decisions on the approvals of the same new drugs. We would like to discuss the appropriateness of Japanese regulatory approach through a case study of quizartinib, a novel anti-leukemia drug developed in Japan. The pivotal clinical trial "QuANTUM-R" conducted in 19 countries showed a modest increase in median overall survival with quizartinib than the conventional chemotherapy. However, because several critical defects in this trial were pointed out by the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA), quizartinib has not been approved in the US and Europe to date. On the contrary, the regulatory authority of Japan gave a notice of approval to quizartinib as a "standard of care", and the country becomes the sole country that granted market authorization. In our paper, we provide more detailed discussion about the methodology for scientific evaluation of the new drug.

Pharmaceutical good manufacturing practice: Leuplin® production in Japan identifies major international shortcomings.

In Japan, the production of Leuplin®, a key drug for the treatment of prostate cancer and breast cancer, was temporarily suspended in 2020 by the manufacturer. The incident illustrated several significant failings, namely the lack of uniformity in international GMP (Good Manufacturing Practice) regulations, the lack of mechanisms to resolve disputes between PIC/S (Pharmaceutical Inspection Co-operation Scheme) member countries, and the importance of maintaining a stable supply of safe GMP-compliant essential medicines.

Pharmaceutical company payments to authors of the Japanese Clinical Practice Guidelines for Hepatitis C treatment.

BACKGROUND & AIMS: Promotional activities of pharmaceutical companies (Pharma) relating to newly marketed direct-acting antivirals (DAAs) may have targeted the authors of the Japanese Clinical Practice Guidelines (CPGs) for Hepatitis C. This study aimed to assess payments made by Pharma to the CPG authors and the financial conflicts of interest (FCOIs) reported by those authors. METHODS: We analyzed payments reported by Pharma to the CPG authors as well as the COI as published by the JSH, using publicly available data for 2016 and 2017. RESULTS: A total of 35 of 78 Pharma-reported payments of $613,973 in 2016, while 40 of 73 Pharma declared payments of $524,674 in 2017, with six companies failing to report. Payments by Pharma manufacturing DAAs accounted for 53.7% of the total (55.7% and 51.6% in 2016 and 2017 respectively). All 17 authors received payments from Pharma which totalled $1,138,647. The mean and median payments per author were $66,979 (standard deviation (SD): $64,875) and $46,033 (interquartile range [IQR]: $29,796 - $34,428) for 2016 and 2017 combined. CONCLUSIONS: Financial relationship between Pharma and the Hepatitis C CPG authors, which was unclear owing to the guideline regulation, was clarified. The authors had the strongest ties to the Pharma which manufactures DAAs in 2016 and 2017.

Financial conflicts of interest between pharmaceutical companies and the authors of urology clinical practice guidelines in Japan.

INTRODUCTION AND HYPOTHESIS: In Japan, the authors of urology clinical practice guidelines (UCPG) used in patient-centered care are often targeted by pharmaceutical companies with financial payments. However, the financial relationship between UCPG authors and pharmaceutical companies remains unclear. This study aimed to determine the characteristics of industry payments to physicians that may influence recommendations in UCPG and to assess the transparency of payment disclosure. METHODS: We considered 193 UCPG authors receiving payments from 79 companies between 2016 and 2017 and the 13 UCPG published by the Japanese Urological Association between 2015 and 2018. We determined 2-year combined mean and median payments to authors, total company payments, and associations between author attributes and payment values using multivariate negative binomial regression. Also, we assessed the extent of the financial disclosure policies among the 13 UCPG. RESULTS: Overall, 171 (88.6%) authors received payments with a combined value of $6,169,333. Median and mean payments were $7147 (interquartile range, $1512-$44,807) and $31,965 (standard deviation, $51,684), respectively. University professors working on multiple UCPG with new drug approvals were associated with higher payments. Twelve (92.3%) UCPG failed to disclose financial conflicts. CONCLUSIONS: While it remains unclear whether financial entanglements improperly influence the contents of UCPG, most Japanese authors received substantial payments from pharmaceutical companies with little or no disclosure. Because insufficient transparency in disclosure of these financial entanglements may compromise the integrity of UCPG, more rigorous regulation and greater disclosure of financial conflicts of interest are needed.

COVID-19: challenges faced by Nepalese migrants living in Japan.

BACKGROUND: Worldwide, COVID-19 has exacerbated the vulnerability of migrants, impacting many facets of their lives. Nepalese make up one of the largest groups of migrants residing in Japan. Crises, such as the ongoing COVID-19 pandemic could disproportionately affect migrants from low- and middle-income countries like Nepal, widening health and economic inequalities. An in-depth, comprehensive assessment is needed to appraise the diverse problems they encounter. Drawing upon qualitative interviews, this study aimed to identify challenges faced by Nepalese migrants in Japan as a consequence of the COVID-19 pandemic and to discuss their needs to counter these challenges. METHODS: This qualitative study employed an interpretivist approach to appraise the first-hand experience of Nepalese migrants living in Japan. Fourteen participants (8 males and 6 females, aged 21 to 47 years old) were recruited to participate in semi-structured in-depth telephone interviews (45-60 min) regarding: (a) their perceived current physical and mental health, (b) problems faced as a result of the COVID-19 pandemic, and (c) perception of available and necessary support structures. Purposive and snowball sampling techniques were used to recruit the participants. Interviews were recorded, transcribed, and thematically analyzed. RESULTS: Six themes were identified: 1) experiencing psychosomatic symptoms, 2) adoption of new healthy behaviors, 3) financial hardship, 4) family concerns, 5) reflections on discrimination and 6) reflections of existing support and expectations of support systems. The findings of our study illustrate the specific impact of COVID-19 among Nepalese migrants regarding their unstable employment conditions, perceived lack of social support, possible obligation to send money home, difficulty in accessing services due to the language barrier, and a lack of effective governmental support from Nepal. Pandemic-related adversity has negatively impacted migrants' mental well-being, exacerbating their vulnerability. CONCLUSIONS: Comprehensive and timely support should be provided to the vulnerable migrant population. Effective coordination among relevant parties in both countries, including the governments concerned, should be facilitated.

Application of the extended theory of planned behavior to understand Chinese students' intention to improve their oral health behaviors: a cross-sectional study.

BACKGROUND: The present study aimed to develop and test an extended theory of planned behavior (TPB), which includes attitudes, subjective norms and perceived behavioral control, oral health knowledge, and past oral health behavior on the intention to improve oral health behaviors among primary school students in Shanghai, China. METHODS: A school-based cross-sectional study was conducted with 414 students in the third-grade from 10 classes of Mingqiang Primary School located in Shanghai, China. Participants were recruited in October 2019. Data were collected through self-reported questionnaires, consisting of demographic characteristics, TPB variables, oral health knowledge and past oral health behaviors. Exploratory factor analysis was used to analyze TPB items. Pearson's correlation and hierarchical regression analyses were conducted to identify the associated factors of intention to improve oral health behaviors. RESULTS: The study showed that among students in the third grade, attitudes, subjective norms, perceived behavioral control, and past oral health behaviors were associated with the intention to improve oral health behaviors. In the hierarchical regression analysis, age and sex were entered in Model 1 which significantly explained 3.00% of the variance (F = 6.26, p < 0.01). The addition of Model 2 variables of attitudes, perceived behavioral control, subjective norms, and oral health knowledge revealed that TPB variables explained 26.70% (F = 29.59, p < 0.01). For Model 3, the addition of past oral health behaviors accounted for a further 1% of variance, and the full model has accounted for 28.30% of the variance with the intention to improve oral health behaviors (F = 22.8, p < 0.01). Regression analyses supported that among the significant variables, perceived behavioral control had the largest beta weight, followed by subjective norms and past oral health behaviors. CONCLUSION: The extended TPB model constructed in this study could be used to explain children's intentions to improve oral health behaviors. Children's oral health-related perceived behavioral control, subjective norms, and past oral health behaviors may serve as priority intervention targets in oral health promotion practices aimed at children.

Accuracy of post-publication Financial Conflict of Interest corrections in medical research: A secondary analysis of pharmaceutical company payments to the authors of the CREATE-X trial report in the New England Journal of Medicine.

In June 2017, Japanese and Korean authors published the results of the CREATE-X trial in the New England Journal of Medicine (NEJM). After we identified their inadequate disclosures of Financial Conflict of Interests (FCOIs), the authors made a post-publication correction of their FCOIs. The purpose of this study is to evaluate the accuracy of the post-publication corrections by the Japanese authors of the CREATE-X trial. All the Japanese authors of the CREATE-X trial were included in the study. We determined the payments received by these authors in 2016 using publicly available data published by 78 pharmaceutical companies based on the stipulated Japanese transparency guidelines. We retrieved the original and revised versions of the FCOI disclosures as published on the NEJM website, and compared the payments reported by the pharmaceutical companies and the original and revised FCOI disclosures of the authors. Of the 12 authors, nine received payments made by the drug manufacturer involved in the CREATE-X trial. Of these nine, only three (33.3%) originally disclosed their relationships, and another three (33.3%) later disclosed such relationships in the post-publication corrections. Similarly, of the 11 receiving at least one payment from other manufacturers of breast cancer products, none correctly disclosed the payments in the original or the revised disclosure. In the CREATE-X trial, FCOIs with pharmaceutical companies were not properly disclosed by 11 of the 12 Japanese authors, even after the post-publication corrections, which highlights the need to pay more attention to the accuracy of FCOI disclosures in academic publications.