Optimizing the Relationship between Regulation and Innovation in Dietary Supplements: A Case Study of Food with Function Claims in Japan.

Regulation has long been a counterpart of innovation in the health care industry, and recent cases have demonstrated that appropriately designed regulations can both coexist with and promote innovation. This study is the first study to explore how the regulatory environment affected the innovation process during the transition of the regulations for functional foods in Japan by examining quantitatively the impact of the foods with function claims (FFC) system on industry, companies, and products. Based on a dataset of Japanese dietary supplement manufacturing companies (n = 169) and their products (n = 731) in 2019, we found that companies that have newly entered the FFC system are smaller in scale than existing companies (p < 0.01, Wilcoxon rank sum test). We also found that companies with FFC products have larger revenue growth (p = 0.01). A multiple regression analysis revealed that FFC product sales increased with in-house clinical testing (coefficient: 26.8, p < 0.0001), diverse active ingredients (coefficient: 7.6, p < 0.001), and the claim of new functions (coefficient: 10.2, p < 0.05). These results suggested that the FFC system facilitated the market entry of small and mid-size enterprises and promoted the creation of high-value products through innovative company efforts.

Exploring the Shift in International Trends in Mobile Health Research From 2000 to 2020: Bibliometric Analysis.

BACKGROUND: Smartphones have become an integral part of our lives with unprecedented popularity and a diverse selection of apps. The continuous upgrading of information technology has also enabled smartphones to display great potential in the field of health care. OBJECTIVE: We aimed to determine the future research direction of mobile health (mHealth) by analyzing its research trends and latest research hotspots. METHODS: This study collected mHealth-related literature published between 2000 and 2020 from the Web of Science database. Descriptive statistics of publication trends of mHealth research were determined by analyzing the annual number of publications in the literature and annual number of publications by country. We constructed visualization network maps of country (or regional) collaborations and author-provided keyword co-occurrences, as well as overlay visualization maps of the average publication year of author-provided keywords to analyze the hotspots and research trends in mHealth research. RESULTS: In total, 12,593 mHealth-related research papers published between 2000 and 2020 were found. The results showed an exponential growth trend in the number of annual publications in mHealth literature. JMIR mHealth and uHealth, the Journal of Medical Internet Research, and JMIR Research Protocols were the 3 top journals with respect to number of publications. The United States remained the leading contributor to the literature in this area (5294/12,593, 42.0%), well ahead of other countries and regions. Other countries and regions also showed a clear trend of annual increases in the number of mHealth publications. The 4 countries with the largest number of publications-the United States, the United Kingdom, Canada, and Australia-were found to cooperate more closely. The rest of the countries and regions showed a clear geographic pattern of cooperation. The keyword co-occurrence analysis of the top 100 authors demonstrated 5 clusters, namely, development of mHealth medical technology and its application to various diseases, use of mHealth technology to improve basic public health and health policy, mHealth self-health testing and management in daily life, adolescent use of mHealth, and mHealth in mental health. The research trends revealed a gradual shift in mHealth research from health policy and improving public health care to the development and social application of mHealth technologies. CONCLUSIONS: To the best of our knowledge, the most current bibliometric analysis dates back to 2016. However, the number of mHealth research published between 2017 and 2020 exceeds the previous total. The results of this study shed light on the latest hotspots and trends in mHealth research. These findings provide a useful overview of the development of the field; they may also serve as a valuable reference and provide guidance for researchers in the digital health field.

Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan.

Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement industry in Japan. A binomial logistic regression analysis showed that each of the following three factors had a positive and significant effect on the company's adoption of GMP: company size in terms of revenue (odds ratio = 1.04, p = 0.019), possession of a manufacturing license for pharmaceutical products (13.7, p = 0.003), and number of own product categories manufactured (3.93, p = 0.00009). These findings strongly suggest that the company's manufacturing capability of pharmaceutical products works as a key driver for the better adoption of a quality standard in the dietary supplement industry in Japan. Few considerations were made for conditions of the adoption and implementation of GMP. The present study empirically contributes by providing key clues for issues in the dietary supplement industry and by forming a theoretical base for policymakers and the regulatory authorities.

A monoclonal antibody raised against a synthetic oxytocin peptide stains mouse hypothalamic neurones.

A monoclonal antibody against oxytocin was generated in 7a5 hybridoma cells derived from myeloma cells and lymphocytes from the spleen of mice immunised with a synthetic oxytocin peptide. The 7a5 monoclonal antibody bound with oxytocin in enzyme-linked immunosorbent assays. 7a5 cell growth medium was diluted up to 5000-fold and used for immunohistochemistry. First, to test the specificity of the 7a5 antibody against oxytocin, we stained brain tissues of oxytocin knockout mice, comprising mice in which the first exon of the oxytocin-neurophysin gene is deleted. No 7a5 immunoreactivity was detected in the paraventricular nucleus (PVN) of the hypothalamus of oxytocin knockout mice; however, this area was strongly stained with the anti-vasopressin polyclonal antibody, HM07. Tissue preparations of the wild-type mouse PVN and supraoptic nucleus (SON) displayed 7a5 immunoreactivity that was indistinguishable from the staining produced with an anti-oxytocin polyclonal antibody, HM06. The immunoreactivity of HM06 in the PVN was similar to that of an anti-oxytocin monoclonal antibody, PS38. We then examined the cross-reactivity of 7a5 with arginine vasopressin. The majority of cell soma and processes stained by 7a5 were not co-stained with the vasopressin antibody in SON and PVN regions. Furthermore, the suprachiasmatic nucleus was stained by the vasopressin antibody but not by 7a5. These results demonstrate that 7a5 is a new anti-oxytocin monoclonal antibody recognising oxytocin and not vasopressin; therefore, 7a5 can be used to investigate the role of oxytocin in the brain.

Holistic cost-effectiveness analysis of anticancer drug regimens in Japan.

Japan officially introduced cost-effectiveness analysis (CEA) in 2019, whereas some countries, such as England, Sweden, Canada, and Australia, have experience with health technology assessment (HTA). Therefore, there are few reports that comprehensively examine the situation of health economic evaluation in Japan. In this paper, we review the health economic evaluation systems among those countries. We also conducted a case study that investigated the time-trend of cost, effectiveness, and incremental cost-effectiveness ratio (ICER) for anticancer drug regimens in Japan. We found a time-trend ICER for breast cancer (BC). Additionally, molecular targeting drugs for BC had a positive effect on the ICER, and both small molecular-targeting drugs and monoclonal antibodies (mAb) had a higher ICER for BC compared with conventional drugs. Finally, we discuss a possible way to implement a health economic evaluation system in Japan.