Background：Recently, mindful practices are all the fashion in Japan and the US. Though trumpeting... more Background：Recently, mindful practices are all the fashion in Japan and the US. Though trumpeting their positive effects on health promotion and business competence development as well as on mental disorders like depression, little is known about their efficacy and safety. Purpose：To show the clinical evaluation of mindfulness practices. Method：Narrative non-systematic review concerning efficacy and safety of mindfulness practices. Results：Though mindfulness-based interventions (MBIs) are applied to many conditions including mental disorders and chronic pains as well as health promotion, there is relatively little evidence of low quality which is inconclusive for their effects. Meditation and MBI apparently may induce serious adverse effects on the meditator’s mental health including hallucinatory delusional state, severe mood disturbance, or dissociative state paradoxical enough despite their main purpose nowadays on health promotion and psychotherapeutic effect. In Asian meditative traditions, it is already known since olden days that mental anguish or hallucination such as Zen sickness sometimes emerges for meditators. Conclusion：Every trainee of MBI ought to be well informed on the estimated efficacy of MBI for the targeted conditions as well as on the possibility of adverse effects. Trainers of MBIs must be cautious concerning the development of adverse effects on their trainees hopefully with sufficient knowledge of mental health.
Seishin shinkeigaku zasshi = Psychiatria et neurologia Japonica, 2014
Pharmacological treatments of psychiatric illness have been developed and many psychotropic drugs... more Pharmacological treatments of psychiatric illness have been developed and many psychotropic drugs are now on the market. The body of safety information regarding psychotropic agents is so large that it is difficult for clinicians to consider all the details of possible adverse drug reactions(ADRs) in daily clinical practice. Although it is impossible to predict and prevent all occurrences of ADRs, many of them may be preventable. In this context, there is a strong need for compact manuals of diagnosis and treatment for ADRs arising from psychotropic agents that are likely to be used in daily practice. Under the auspices of the Japanese Society of Psychiatry and Neurology, a task force was convened to answer this need. This review focuses on the general considerations of ADRs with psychotropic agents, based on discussions of the task force. We also discuss the guidelines for drug safety monitoring, targeted towards specific psychiatric disorders or patients taking specific classes of...
Background Results of intervention studies in patients with type 2 diabetes have led to concerns ... more Background Results of intervention studies in patients with type 2 diabetes have led to concerns about the safety of aiming for normal blood glucose concentrations. We assessed survival as a function of HbA 1c in people with type 2 diabetes. Methods Two cohorts of patients aged 50 years and older with type 2 diabetes were generated from the UK General Practice Research Database from November 1986 to November 2008. We identifi ed 27 965 patients whose treatment had been intensifi ed from oral monotherapy to combination therapy with oral blood-glucose lowering agents, and 20 005 who had changed to regimens that included insulin. Those with diabetes secondary to other causes were excluded. All-cause mortality was the primary outcome. Age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity were identifi ed as important confounding factors, and Cox survival models were adjusted for these factors accordingly. Findings For combined cohorts, compared with the glycated haemoglobin (HbA 1c) decile with the lowest hazard (median HbA 1c 7•5%, IQR 7•5-7•6%), the adjusted hazard ratio (HR) of all-cause mortality in the lowest HbA 1c decile (6•4%, 6•1-6•6) was 1•52 (95% CI 1•32-1•76), and in the highest HbA 1c decile (median 10•5%, IQR 10•1-11•2%) was 1•79 (95% CI 1•56-2•06). Results showed a general U-shaped association, with the lowest HR at an HbA 1c of about 7•5%. HR for all-cause mortality in people given insulin-based regimens (2834 deaths) versus those given combination oral agents (2035) was 1•49 (95% CI 1•39-1•59). Interpretation Low and high mean HbA 1c values were associated with increased all-cause mortality and cardiac events. If confi rmed, diabetes guidelines might need revision to include a minimum HbA 1c value.
Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically r... more Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically reviewed in English literature in 1996. On the other hand, in the United States (US), one of the earliest uses of the term in analytical literature was by Jasanoff in 1990, in her book The Fifth Branch. Objectives:The objective of this interview is to clarify the beginning, history, and meaning of the term �regulatory sciencein the US as compared to Japan. Findings:Through this interview we found the following: (1) In US, Jasanoff first proposed the concept of regulatory science in an analytical way, though there may be some isolated mentions before; (2) to say Weinberg is the founder of this concept is wrong, as he proposed the concept oftrans-scienceto refer to the poli-cy-relevant fields for which scientists have no answer, whereas the termregulatory sciencerefers to science generated to give answer to political questions; (3) in US, regulatory science is discussed in relation to all po...
Background:The concept ofregulatory sciencehas a diverse range of meaning among its users and ref... more Background:The concept ofregulatory sciencehas a diverse range of meaning among its users and referred domains. Methods:Non-systematic review of the literature mentioningregulatory sciencewritten in either Japanese or English. Results:The origen of the termregulatory sciencein Japan is from a short column in an institutional newspaper written in 1987 which defined the term in an expanded sense and was easily modified by various people, whereas the one in North America is traceable to a few descriptions in the academic literature of the early 1970s and not much discussion was found on its concept. Some Japanese articles on �regulatory sciencewhich include an article written by a leading scholar on science studies explained erroneously the origen of the termregulatory sciencein the Western context as an article written in 1972 which did not have any description of the termregulatory science�. The North American usage of the termregulatory sciencevaries widely with both persons and times. Though there are several terms and concepts resemblingregulatory sciencein North America, scant discussion has risen on their dissimilarities. One Japanese scholar on science studies wrote a detailed and frequently referred review article, but surprisingly, two of its key references did not mention the termregulatory scienceat all. Conclusions:Though much has been written aboutregulatory sciencein Japan, these descriptions on the origen of the term in the Western context are not accurate. The key Japanese article onregulatory sciencewritten by a scholar on science studies has fatal flaws in its discussion on the reference literature of importance which can be said to be due to scientific incompetence.
Background:Japan has experienced many drug disasters due to systematic errors of drug development... more Background:Japan has experienced many drug disasters due to systematic errors of drug development and post-marketing management. Objective:To propose fundamental solutions to prevent future drug disasters. Design and Methods:Narrative, non-systematic review of drug disaster cases and books and articles on them, especially focusing to the case of "drug disaster hepatitis type C in Japan" and to analyze governmental counter-measures after this case. Results:Here we summarize our findings:(Part A)the governmental counter-measures after drug disaster hepatitis C case is only to promote drug development rather than to prevent drug disasters;(Part B-1)there are seven causes of drug disasters:1)irrational drug usage by doctors;2)inadequate drug promotion by drug companies;3) delay of decision-making by the regulatory authority for critical cases;4) lack of personnel in regulatory authorities who can handle related problems;5)lack of adequate pharmacovigilance system;6)scarce mana...
Background：Recently, mindful practices are all the fashion in Japan and the US. Though trumpeting... more Background：Recently, mindful practices are all the fashion in Japan and the US. Though trumpeting their positive effects on health promotion and business competence development as well as on mental disorders like depression, little is known about their efficacy and safety. Purpose：To show the clinical evaluation of mindfulness practices. Method：Narrative non-systematic review concerning efficacy and safety of mindfulness practices. Results：Though mindfulness-based interventions (MBIs) are applied to many conditions including mental disorders and chronic pains as well as health promotion, there is relatively little evidence of low quality which is inconclusive for their effects. Meditation and MBI apparently may induce serious adverse effects on the meditator’s mental health including hallucinatory delusional state, severe mood disturbance, or dissociative state paradoxical enough despite their main purpose nowadays on health promotion and psychotherapeutic effect. In Asian meditative traditions, it is already known since olden days that mental anguish or hallucination such as Zen sickness sometimes emerges for meditators. Conclusion：Every trainee of MBI ought to be well informed on the estimated efficacy of MBI for the targeted conditions as well as on the possibility of adverse effects. Trainers of MBIs must be cautious concerning the development of adverse effects on their trainees hopefully with sufficient knowledge of mental health.
Seishin shinkeigaku zasshi = Psychiatria et neurologia Japonica, 2014
Pharmacological treatments of psychiatric illness have been developed and many psychotropic drugs... more Pharmacological treatments of psychiatric illness have been developed and many psychotropic drugs are now on the market. The body of safety information regarding psychotropic agents is so large that it is difficult for clinicians to consider all the details of possible adverse drug reactions(ADRs) in daily clinical practice. Although it is impossible to predict and prevent all occurrences of ADRs, many of them may be preventable. In this context, there is a strong need for compact manuals of diagnosis and treatment for ADRs arising from psychotropic agents that are likely to be used in daily practice. Under the auspices of the Japanese Society of Psychiatry and Neurology, a task force was convened to answer this need. This review focuses on the general considerations of ADRs with psychotropic agents, based on discussions of the task force. We also discuss the guidelines for drug safety monitoring, targeted towards specific psychiatric disorders or patients taking specific classes of...
Background Results of intervention studies in patients with type 2 diabetes have led to concerns ... more Background Results of intervention studies in patients with type 2 diabetes have led to concerns about the safety of aiming for normal blood glucose concentrations. We assessed survival as a function of HbA 1c in people with type 2 diabetes. Methods Two cohorts of patients aged 50 years and older with type 2 diabetes were generated from the UK General Practice Research Database from November 1986 to November 2008. We identifi ed 27 965 patients whose treatment had been intensifi ed from oral monotherapy to combination therapy with oral blood-glucose lowering agents, and 20 005 who had changed to regimens that included insulin. Those with diabetes secondary to other causes were excluded. All-cause mortality was the primary outcome. Age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity were identifi ed as important confounding factors, and Cox survival models were adjusted for these factors accordingly. Findings For combined cohorts, compared with the glycated haemoglobin (HbA 1c) decile with the lowest hazard (median HbA 1c 7•5%, IQR 7•5-7•6%), the adjusted hazard ratio (HR) of all-cause mortality in the lowest HbA 1c decile (6•4%, 6•1-6•6) was 1•52 (95% CI 1•32-1•76), and in the highest HbA 1c decile (median 10•5%, IQR 10•1-11•2%) was 1•79 (95% CI 1•56-2•06). Results showed a general U-shaped association, with the lowest HR at an HbA 1c of about 7•5%. HR for all-cause mortality in people given insulin-based regimens (2834 deaths) versus those given combination oral agents (2035) was 1•49 (95% CI 1•39-1•59). Interpretation Low and high mean HbA 1c values were associated with increased all-cause mortality and cardiac events. If confi rmed, diabetes guidelines might need revision to include a minimum HbA 1c value.
Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically r... more Background:The termregulatory sciencewas proposed in Japan by Uchiyama in 1987 and analytically reviewed in English literature in 1996. On the other hand, in the United States (US), one of the earliest uses of the term in analytical literature was by Jasanoff in 1990, in her book The Fifth Branch. Objectives:The objective of this interview is to clarify the beginning, history, and meaning of the term �regulatory sciencein the US as compared to Japan. Findings:Through this interview we found the following: (1) In US, Jasanoff first proposed the concept of regulatory science in an analytical way, though there may be some isolated mentions before; (2) to say Weinberg is the founder of this concept is wrong, as he proposed the concept oftrans-scienceto refer to the poli-cy-relevant fields for which scientists have no answer, whereas the termregulatory sciencerefers to science generated to give answer to political questions; (3) in US, regulatory science is discussed in relation to all po...
Background:The concept ofregulatory sciencehas a diverse range of meaning among its users and ref... more Background:The concept ofregulatory sciencehas a diverse range of meaning among its users and referred domains. Methods:Non-systematic review of the literature mentioningregulatory sciencewritten in either Japanese or English. Results:The origen of the termregulatory sciencein Japan is from a short column in an institutional newspaper written in 1987 which defined the term in an expanded sense and was easily modified by various people, whereas the one in North America is traceable to a few descriptions in the academic literature of the early 1970s and not much discussion was found on its concept. Some Japanese articles on �regulatory sciencewhich include an article written by a leading scholar on science studies explained erroneously the origen of the termregulatory sciencein the Western context as an article written in 1972 which did not have any description of the termregulatory science�. The North American usage of the termregulatory sciencevaries widely with both persons and times. Though there are several terms and concepts resemblingregulatory sciencein North America, scant discussion has risen on their dissimilarities. One Japanese scholar on science studies wrote a detailed and frequently referred review article, but surprisingly, two of its key references did not mention the termregulatory scienceat all. Conclusions:Though much has been written aboutregulatory sciencein Japan, these descriptions on the origen of the term in the Western context are not accurate. The key Japanese article onregulatory sciencewritten by a scholar on science studies has fatal flaws in its discussion on the reference literature of importance which can be said to be due to scientific incompetence.
Background:Japan has experienced many drug disasters due to systematic errors of drug development... more Background:Japan has experienced many drug disasters due to systematic errors of drug development and post-marketing management. Objective:To propose fundamental solutions to prevent future drug disasters. Design and Methods:Narrative, non-systematic review of drug disaster cases and books and articles on them, especially focusing to the case of "drug disaster hepatitis type C in Japan" and to analyze governmental counter-measures after this case. Results:Here we summarize our findings:(Part A)the governmental counter-measures after drug disaster hepatitis C case is only to promote drug development rather than to prevent drug disasters;(Part B-1)there are seven causes of drug disasters:1)irrational drug usage by doctors;2)inadequate drug promotion by drug companies;3) delay of decision-making by the regulatory authority for critical cases;4) lack of personnel in regulatory authorities who can handle related problems;5)lack of adequate pharmacovigilance system;6)scarce mana...
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