Does the Act on the Safety of Regenerative Medicine in Japan ensure "safety"?: Implications of low adverse event reporting.

Public document analysis reveals that the adverse events reported for therapeutic administration under the Act on the Safety of Regenerative Medicine (ASRM) in Japan are substantially fewer than those under the Pharmaceuticals and Medical Devices Act. This study highlights the flawed reporting mechanisms and unmet legislative intentions of the ASRM.

Difficulties in ensuring review quality performed by committees under the Act on the Safety of Regenerative Medicine in Japan.

We outlined five studies regarding the quality of the review by committees based on the Act on the Safety of Regenerative Medicine. The findings raise serious concerns about the independence, integrity, and quality of reviews of therapeutic plans by these committees with inappropriately close relationships to medical institutions and companies.

Public Attitudes toward COVID-19 Vaccinations before Dawn in Japan: Ethics and Future Perspectives.

Improving public understanding and acceptance are critical for promoting coronavirus (COVID-19) vaccination. However, how to promote COVID-19 vaccine programs remains controversial due to various ethical issues. This study, thus, aimed to survey the acceptance of COVID-19 vaccines among Japanese citizens and discuss relevant ethical issues. A cross-sectional survey was conducted via an online platform. An anonymous, quantitative, self-administered online questionnaire was sent to 6965 registered Japanese residents (20-79 years of age), which included questions regarding the respondent's general knowledge, experience, and opinions of vaccines, vaccine development, COVID-19, and COVID-19 vaccines. Of the 1569 respondents, 730 (46.5%) and 839 (53.5%) were categorized into the younger and older groups, respectively. Most of the respondents possessed general knowledge of COVID-19 vaccines and their features. Of the respondents, 57.8% definitely agreed (10.5%) or somewhat agreed (47.3%) to receive COVID-19 vaccines. The older group showed significantly greater willingness to receive vaccines and higher literacy regarding vaccines in general. Possible reasons for the older group's greater willingness to receive COVID-19 vaccines are a high risk of severe COVID-19 infection and their past accumulated experience of receiving various vaccinations. Although active public intervention could increase vaccination rates, most of the respondents did not agree with mandatory vaccination. Furthermore, a gap between the participants in the COVID-19 vaccine trials and the prioritized population in real-world vaccination should be adjusted in future vaccine development. Supplementary Information: The online version contains supplementary material available at 10.1007/s41649-022-00207-4.

Financial risks posed by unproven cell interventions: Estimation of refunds from medical expense deductions in Japan.

Master et al. (2021) declared that the unproven stem cell intervention (SCI) industry is a global health problem. We fully agree with this opinion but would like to point out that there are financial risks. In this letter, we estimate the total refund amount paid by the government for cell-based interventions offered under private practice in Japan.

Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies' Activities in Japan.

OBJECTIVE: The objective of this study is to assess public attitudes toward pharmaceutical companies' secondary uses of patient records and public preferences regarding consent approaches. METHOD: 3000 responses to an online survey were collected from adults in Japan. The questionnaire included 32 items related to (1) awareness of "clinical trials"; (2) awareness of the processes of drug development, such as cost, time, and the number of candidate substances in a new drug; (3) knowledge of the laws and regulations for use of patient records in Japan; (4) assessment of the public benefit of the secondary use of patient records; (5) preferences for consent for the secondary use of patient records; and (6) basic characteristics of the respondents. RESULTS: The public benefit from secondary use of records by academic institutions for scientific research was rated highest. All of the activities by pharmaceutical companies were rated higher than those by governmental institutions and other for-profit companies. Regarding consent approaches, 37.9% preferred an "opt-in" approach for new drug development by pharmaceutical companies, 79.7% of whom would change their preference to an "opt-out" approach under specific conditions, such as ensuring intended uses only. CONCLUSION: Our respondents consider the "public benefit" as dependent on the relative distance from "promoting public health" when assessing the secondary purpose of patient record use. Pharmaceutical companies should include the beneficial purposes when using patient records with "opt-out" approach. Policy makers should pay more attention to the purposes of use when developing personal information protection policies.

Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies' Activities in Japan.

OBJECTIVE: The objective of this study is to assess public attitudes toward pharmaceutical companies' secondary uses of patient records and public preferences regarding consent approaches. METHOD: 3000 responses to an online survey were collected from adults in Japan. The questionnaire included 32 items related to (1) awareness of "clinical trials"; (2) awareness of the processes of drug development, such as cost, time, and the number of candidate substances in a new drug; (3) knowledge of the laws and regulations for use of patient records in Japan; (4) assessment of the public benefit of the secondary use of patient records; (5) preferences for consent for the secondary use of patient records; and (6) basic characteristics of the respondents. RESULTS: The public benefit from secondary use of records by academic institutions for scientific research was rated highest. All of the activities by pharmaceutical companies were rated higher than those by governmental institutions and other for-profit companies. Regarding consent approaches, 37.9% preferred an "opt-in" approach for new drug development by pharmaceutical companies, 79.7% of whom would change their preference to an "opt-out" approach under specific conditions, such as ensuring intended uses only. CONCLUSION: Our respondents consider the "public benefit" as dependent on the relative distance from "promoting public health" when assessing the secondary purpose of patient record use. Pharmaceutical companies should include the beneficial purposes when using patient records with "opt-out" approach. Policy makers should pay more attention to the purposes of use when developing personal information protection policies.

A Comparative Analysis of Attitudes on Communication Toward Stem Cell Research and Regenerative Medicine Between the Public and the Scientific Community.

Owing to the rapid progress in stem cell research (SCR) and regenerative medicine (RM), society's expectation and interest in these fields are increasing. For effective communication on issues concerning SCR and RM, surveys for understanding the interests of stakeholders is essential. For this purpose, we conducted a large-scale survey with 2,160 public responses and 1,115 responses from the member of the Japanese Society for Regenerative Medicine. Results showed that the public is more interested in the post-realization aspects of RM, such as cost of care, countermeasures for risks and accidents, and clarification of responsibility and liability, than in the scientific aspects; the latter is of greater interest only to scientists. Our data indicate that an increased awareness about RM-associated social responsibility and regulatory framework is required among scientists, such as those regarding its benefits, potential accidents, abuse, and other social consequences. Awareness regarding the importance of communication and education for scientists are critical to bridge the gaps in the interests of the public and scientists. Stem Cells Translational Medicine 2018;7:251-257.

Science communication in regenerative medicine: Implications for the role of academic society and science policy.

It is essential to understand the hurdles, motivation, and other issues affecting scientists' active participation in science communication to bridge the gap between science and society. This study analyzed 1115 responses of Japanese scientists regarding their attitudes toward science communication through a questionnaire focusing on the field of stem cell and regenerative medicine. As a result, we found that scientists face systemic issues such as lack of funding, time, opportunities, and evaluation systems for science communication. At the same time, there is a disparity of attitudes toward media discourse between scientists and the public.

Oral nutrition or the ability to speak: the choice faced by a cancer survivor.

Patients with head and neck cancer often suffer from breathing, speaking, and eating deficits, which negatively affect their quality of life. These patients are often observed to repeatedly contract aspiration pneumonia, resulting in prolonged hospital stays. To help prevent aspiration pneumonia, enteral nutrition is often provided. Although this method helps avoid pneumonia, patients need to give up eating by mouth. Because oral intake of food is closely related to patient quality of life, abandoning eating results in a strong internal conflict. This report describes the case of a cancer patient who experienced repeated aspiration pneumonias after neck surgery. The patient required enteral nutrition to avoid repeated bouts of pneumonia. However, the patient opted for laryngeal closure surgery to regain the ability to take food orally, at the expense of his voice. The patient's choice caused an ethical conflict for the attending medical professionals, highlighting the need for physicians to communicate with their patients to understand their patients' sense of values.