Unveiling, Analyzing the Mechanisms of, and Proposing Solutions for Bribery in Japan's Medical Device Sector.

Both public and academic scrutiny of the financial relationships between the medical device industry and the healthcare society occur less frequently than those involving the pharmaceutical industry, and Japan is no exception to these shortcomings. This paper examines the ethical and legal challenges inherent in Japan's medical device industry through the lens of bribery scandals, placing these issues within the broader context of global healthcare corruption. It aims to derive lessons and suggest universal strategies for ethical and legal enhancements. The discussion includes two notable cases: one involving inappropriate transactions between a cancer center and a biliary stent manufacturer, and another concerning a corrupt donation scheme between a medical device company and a university's anesthesiology department, which was found guilty. In our analysis, we also acknowledge the industry's efforts toward compliance and reform to maintain a balanced perspective. The analysis not only highlights the unique culture and structure of the Japanese medical device industry, such as the exploitation of flexible pricing and opaque financial practices but also contrasts these issues with the tightly regulated pharmaceutical industry. This approach reveals both sector-specific challenges and common corruption drivers, enhancing our understanding of why such scandals occur and persist. We propose ethical and compliance-focused business measures such as centralizing donation decisions, limiting the financial independence of marketing divisions, and increasing transparency, alongside adopting mandatory disclosure practices based on successful models from the United States and Europe. By emphasizing integrity and presenting diverse perspectives, this study aims to elevate ethical and legal standards in the medical device industry and improve patient health outcomes worldwide.

Risk Index of Regional Infection Expansion in COVID19: Moving Direction Entropy using Mobility Data and Its Application to Tokyo.

BACKGROUND: Policies such as Staying Home, bubbling, and Staying with Your Community, recommending that individuals reduce contact with diverse communities, including families and schools, have been introduced to mitigate the spread of the COVID-19 pandemic. However, these policies are violated if individuals from various communities gather - a latent risk in the real society where people move among various unreported communities. OBJECTIVE: We aimed to create a physical index to assess the possibility of contact between individuals from diverse communities, which serves as an indicator of the potential risk of SARS-CoV-2 spread if taken into account combined with existing indices. METHODS: Moving Direction Entropy (MDE), which quantifies the diversity of moving directions of individuals in each local region, is here proposed as an index to evaluate a region's risk of contacts of individuals from diverse communities. MDE was computed for each inland municipality in Tokyo using mobility data collected from smartphones from before to during the COVID-19 pandemic. To validate the hypothesis that the impact of inter-community contact on infection expansion becomes larger for a virus with larger infectivity, we compared the correlations of the expansion of infectious diseases with indices including MDE and the densities of supermarkets, restaurants, etc. In addition, we analyzed the temporal changes in MDE in municipalities. RESULTS: First, the MDEs for local regions showed significant invariance between different periods according to Spearman's rank correlation coefficient (>0.9). Second, the MDE was found to correlate with the rate of infection cases of COVID-19 over local populations in the 53 inland regions: 0.76 in average during the periods of expansion. The density of restaurants had a similar correlation with COVID-19. The correlation with MDE was higher for COVID-19 than for influenza, which was higher than for sexually transmitted diseases, that is, in the order of infectivity, which supports the hypothesis in Methods. Third, the spread of COVID-19 was accelerated in regions with high-rank MDEs compared to those with high-rank restaurant densities during and after the period of governmental declarations of emergency (p < .001). Fourth, the MDEs tended to be high and increased during the pandemic period in regions where influx or daytime movement was active. A possible explanation for the third and fourth findings is that policymakers and living people have been overlooking MDE. CONCLUSIONS: We propose monitoring the regional values of MDE to reduce the risk of infection spread. To aid in this monitoring, we present a method to create a heat map of MDE values, thereby drawing public attention to behaviors that facilitate contact between communities during a highly infectious disease pandemic. CLINICALTRIAL: This study was not registered in a clinical trial registry because it used mobility data from smartphones and other available data, without trials.

Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.

Regulatory authorities must balance ensuring evidence of efficacy and safety of new drugs. Various regulatory pathways, such as the accelerated approval program in the United States (US), allow authorities to quickly approve drugs for severely ill patients by granting market authorization based on surrogate end points and pending confirmatory trials. In this cross-sectional study, we considered 23 indications of cancer drugs that received accelerated approval by the US Food and Drug Administration (FDA) but were subsequently withdrawn as of April 2023. Our investigation extended to assessing the regulatory status of these accelerated approvals in the European Union (EU) and Japan, examining relevant regulatory documents and identifying factors contributing to the withdrawal in the United States. Comparing regions, we found that for 52% (12/23) and 30% (7/23) of withdrawn accelerated approvals in the United States, sponsors had also sought marketing authorization from the European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), respectively. As of the April 30, 2023 study cutoff date, 83% (10/12) of drug-indication pairs remained approved by the EMA, while the PMDA retained 100% (7/7). For these indications, the time from FDA withdrawal until the study cutoff date ranged from 0.23 years to 11.45 years for EMA approvals (median: 1.28 years) and 1.10 years to 11.45 years for PMDA approvals (median: 3.22 years). These findings highlight substantial regulatory discrepancies concerning cancer drugs with unconfirmed benefits. Addressing these discrepancies may involve requiring pharmaceutical companies to confirm clinical benefits using more robust end points and fostering international harmonization in regulators' assessment.

Bridging the Gap in United Nations Environment Programme's Report: The Potential of Nudges to Reduce Plastic Pollution and Health Risks.

Plastic pollution is increasingly becoming a threatening problem worldwide, with highlighted health risks associated with plastic waste incineration. Among the immediate measures to address this problem, proper recycling of polyethylene terephthalate (PET) bottles is a pertinent strategy. Considering the urgent need for administrative-led reforms, we assessed the separation rates of PET bottle caps and labels by 125 administrative staff in a government office of a prefectural in Japan during a four-day period; only 59.3% (48/81) of the pet bottles had both caps and labels removed and properly separated to each trash can. One potential solution for the low separation rate is the use of nudges, which are effective methods for promoting behaviors such as healthy actions. Since both health and environmentally conscious behaviors involve choices across different time points, leveraging insights from nudges developed in the field of health behavior to environmental behaviors is considered crucial, even from a health promotion perspective.

Association Between Gender and Payments Received From Pharmaceutical Companies Among Medical Professors and Associate Professors in Japan.

Introduction While prior research showed gender gaps in industry payments for medical professionals in the United States, there are limited data in Japan. So, this study seeks to investigate the potential gender gap in the receipt of pharmaceutical companies (PFCs) across all medical fields in Japan. Based on the results of previous studies, we developed a hypothesis that male doctors get more PFC than female doctors. Materials and methods Data from 92 pharmaceutical companies in Japan, covering 2016 to 2019, were analyzed. The analysis was conducted on professors and associate professors at all national and public medical universities in Japan, with gender as a factor variable and payments as an outcome variable, and variables that may have influenced the factor or outcome variables in previous studies, such as specialization, university type, region, rank and years since graduation, as control variables. Payments were converted to US dollars using the December 31, 2021, rate of 115 yen to the dollar for comparison purposes. Results Out of 1,825 subjects, 1,755 were males and 70 females. Males consistently received higher median payments from pharmaceutical companies (PFCs) than females across categories. In particular, among physicians specializing in internal medicine, the median PFC for men was $25 compared to $8 for women. For physicians affiliated with former imperial universities (the seven former imperial universities founded before World War II), the median PFC for men was $32 compared to $5 for women. Multivariate analysis confirmed significantly higher total benefits for males from 2016 to 2019, with the gender gap widening during this period (incidence rate ratio (IRR) for 2016: 0.51, IRR for 2019: 0.44). Conclusions Japanese male professors and associate professors received significantly higher PFCs than their female counterparts, and this gender gap expanded from 2016 to 2019, highlighting persistent gender inequality in the medical field in Japan, similar to trends observed in the United States.

Evaluating ChatGPT's effectiveness and tendencies in Japanese internal medicine.

INTRODUCTION: ChatGPT, a large-scale language model, is a notable example of AI's potential in health care. However, its effectiveness in clinical settings, especially when compared to human physicians, is not fully understood. This study evaluates ChatGPT's capabilities and limitations in answering questions for Japanese internal medicine specialists, aiming to clarify its accuracy and tendencies in both correct and incorrect responses. METHODS: We utilized ChatGPT's answers on four sets of self-training questions for internal medicine specialists in Japan from 2020 to 2023. We ran three trials for each set to evaluate its overall accuracy and performance on nonimage questions. Subsequently, we categorized the questions into two groups: those ChatGPT consistently answered correctly (Confirmed Correct Answer, CCA) and those it consistently answered incorrectly (Confirmed Incorrect Answer, CIA). For these groups, we calculated the average accuracy rates and 95% confidence intervals based on the actual performance of internal medicine physicians on each question and analyzed the statistical significance between the two groups. This process was then similarly applied to the subset of nonimage CCA and CIA questions. RESULTS: ChatGPT's overall accuracy rate was 59.05%, increasing to 65.76% for nonimage questions. 24.87% of the questions had answers that varied between correct and incorrect in the three trials. Despite surpassing the passing threshold for nonimage questions, ChatGPT's accuracy was lower than that of human specialists. There was a significant variance in accuracy between CCA and CIA groups, with ChatGPT mirroring human physician patterns in responding to different question types. CONCLUSION: This study underscores ChatGPT's potential utility and limitations in internal medicine. While effective in some aspects, its dependence on question type and context suggests that it should supplement, not replace, professional medical judgment. Further research is needed to integrate Artificial Intelligence tools like ChatGPT more effectively into specialized medical practices.

Nature and Trend of Pharmaceutical Payments to Japanese Board-Certified Neurologists Between 2016 and 2019: A Pre-emergence Analysis Amidst the Development of Next-Generation Alzheimer's Disease Drugs.

OBJECTIVE: There is insufficient data on the financial relationships between Japanese neurologists and pharmaceutical companies prior to the advent of new-generation Alzheimer's disease drugs. The purpose of this study is to evaluate the magnitude, prevalence, and trend of the financial relationship between Japanese neurologists and pharmaceutical companies between 2016 and 2019. METHODS: A cross-sectional study was undertaken to evaluate the financial relationships between all board-certified neurology specialists and pharmaceutical companies in Japan from 2016 and 2019. Descriptive statistics were applied to measure the magnitude and prevalence of payments among specialists, as well as their trends during the study periods. RESULTS: In a four-year analysis, 77 pharmaceutical companies disbursed a total of USD 36,869,204 across 50,050 payments to 2,696 neurologists in Japan, revealing a mean payment of USD 10,809 per specialist. Notably, the Gini index of 0.997 indicated a high inequality in payment distribution, with a minority of specialists receiving a substantial proportion of payments. Trends displayed irregularities, but an overall increase in total payments from 2016 to 2019, with a significant contribution from the top 10 pharmaceutical companies accounting for 74.2% of total payments, with Takeda Pharmaceutical and Eisai Company notably increasing payments in 2019. There were notable geographical variations in neurologist and payment distribution across 47 prefectures. CONCLUSION: Our analysis of neurologist payments from pharmaceutical companies in Japan showed a substantial financial relationship with overall increases, yearly varied increments, and payment inequality. Caution is warranted as financial ties may intensify with the continued development of next-generation Alzheimer's disease drugs.

Intramuscular vs. Subcutaneous: Rethinking Influenza Vaccination Strategy in Japan.

In Japan, inactivated vaccines, including the influenza vaccine, are administered subcutaneously, which is contrary to global recommendations for intramuscular injections. This practice is attributed to historical medical incidents and unchallenged conventions. However, this outdated method, which differs from that of international standards and is linked with less immunogenicity and more adverse reactions, may contribute to vaccination hesitancy. Therefore, with the adoption of intramuscular vaccination administration, which was widely adopted in the coronavirus disease 2019 vaccination, a shift in the Japanese health policy to conform to international standards potentially improves vaccine acceptance and effectiveness.