Taichi Hatta

The current status of clinics providing private practice cell therapy in Japan

AIM To clarify the current state of clinics in Japan that offer unproven cell therapies. METHODS Google searches were performed to collect and analyze what kind of clinics provide what kind of cell therapies. RESULTS A total of 74 clinics and 247 cases of cell therapies were identified. Various cell therapies, including allograft, were provided not only to seriously ill patients but also to patients with other therapeutic options and healthy individuals. DISCUSSION Although the practices revealed by our study seem to deviate from international standard, some of these can be construed as legal under the Japanese new act established in 2014. CONCLUSION Considering many patients travel to foreign countries to seek therapy, more research from non-English-speaking countries is needed.

Public attitudes in Japan towards human–animal chimeric embryo research using human induced pluripotent stem cells

AIM To understand the steps and objectives for which Japanese people are willing to accept human-animal chimeric embryo research using human induced pluripotent stem cells. METHODS An internet-based survey was conducted for the general public and researchers in Japan in 2016. RESULTS Over 60% of the public and 83.8% of researchers supported the creation of human-swine chimeras and 81.0% of the public and 92.4% of researchers supported the creation of human-swine chimeric embryos. DISCUSSION When presented with a graded view of human-swine chimeric embryo research with concomitant, specific objectives, a large majority of the general public as well as researchers are willing to accept this research with the aims of disease study, novel drug and treatment development, and transplantation.

Evaluating the Quality of Website Information of Private-Practice Clinics Offering Cell Therapies in Japan.

Background Although the safety and effectiveness of stem cell therapies are yet to be proven, recent studies show that such therapies are being advertised with some questionable marketing techniques to effect positive portrayal of the therapies on the webpages of private-practice clinics to sell their therapies worldwide. In such context, those clinics communicate directly with consumers (patients and their family members) via the clinics’ websites. Meanwhile, the Health Science Council at the Ministry of Health, Labour, and Welfare (MHLW) in Japan has pointed out noncompliance of some local clinics with the provisions concerning medical advertising in the Medical Care Act in the past. However, locally little is known about the current status of those clinics including the quality of their webpage information disseminated. Objective To evaluate the quality of website information of private-practice clinics offering cell therapies in Japan. Methods Twenty-four websites with 77 treatments from the Google search were identified for evaluation. The following three exploratory analyses were performed: first in order to ascertain web-based portrayal of private-practice clinics offering cell therapies, a descriptive analysis was conducted using a coding frame; second we evaluated the quality of the target website information from the viewpoint of the level of consideration taken for patients and their family members, using 10 quality criteria (“the Minimum Standard”) from the e-Health Code of Ethics 2.0; third we counted and coded expressions that matched set categories for “name-dropping” and “personalized medicine” in the information posted on these websites. Results Analysis on the treatments (N=77) revealed 126 indications (multiple response): the top three indications were “cancer,” “skin-rejuvenation/antiaging/anti–skin aging,” and “breast augmentation/buttock augmentation.” As for the portrayal of treatment risks and benefits, 78% (60/77) of treatments were mentioned with “benefits,” whereas 77% (59/77) of treatments were mentioned with “risks.” As for the source(s) cited for the discussions of treatment risks and benefits, no treatment quoted an expert’s opinion for the risks, whereas 7% (6/77) treatments quoted external sources for the benefits. As for the results with e-Health Code of Ethics 2.0, not a single clinic fulfilled all the 10 criteria; 63% (15/24) of the clinics was found exercising “name-dropping,” and 21% (5/24) of the clinics mentioned expressions related to “personalized medicine” on their websites. Conclusions Our website content analyses confirmed the following: (1) the clinics mentioned the risks or benefits of the treatments with hardly any scientific citations, (2) the way the website information was disseminated was inappropriate for patients and their families, and (3) many websites seemed to be using marketing techniques in order to draw patients’ interests or attentions. It is important that more similar studies are undertaken globally to enable an orchestrated regulatory approach toward private-practice clinics.

An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital

BackgroundInternational clinical trials are now rapidly expanding into Asia. However, the proportion of global trials is higher in South Korea compared to Japan despite implementation of similar governmental support in both countries. The difference in clinical trial environment might influence the respective physicians’ attitudes and experience towards clinical trials. Therefore, we designed a questionnaire to explore how physicians conceive the issues surrounding clinical trials in both countries.MethodsA questionnaire survey was conducted at Kyoto University Hospital (KUHP) and Seoul National University Hospital (SNUH) in 2008. The questionnaire consisted of 15 questions and 2 open-ended questions on broad key issues relating to clinical trials.ResultsThe number of responders was 301 at KUHP and 398 at SNUH. Doctors with trial experience were 196 at KUHP and 150 at SNUH. Among them, 12% (24/196) at KUHP and 41% (61/150) at SUNH had global trial experience. Most respondents at both institutions viewed clinical trials favorably and thought that conducting clinical trials contributed to medical advances, which would ultimately lead to new and better treatments. The main reason raised as a hindrance to conducting clinical trials was the lack of personnel support and time. Doctors at both university hospitals thought that more clinical research coordinators were required to conduct clinical trials more efficiently. KUHP doctors were driven mainly by pure academic interest or for their desire to find new treatments, while obtaining credits for board certification and co-authorship on manuscripts also served as motivation factors for doctors at SNUH.ConclusionsOur results revealed that there might be two different approaches to increase clinical trial activity. One is a social level approach to establish clinical trial infrastructure providing sufficient clinical research professionals. The other is an individual level approach that would provide incentives to encourage doctors to participate in and conduct clinical trials.

Risk of Tumorigenesis and Patient Hope

Hurst, S. A., A. Mauron, S. Momjian, and P. R. Burkhard. 2015. Ethical criteria for human trials of stem-cell-derived dopaminergic neurons in Parkinson’s disease. AJOB Neuroscience 6(1): 52–60. Ilkilic, I., and H. Ertin. 2010. Ethical aspects of human embryonic stem cell research in the Islamic world: Positions and reflections. Stem Cell Reviews 6(2): 151–161. Available at: http://dx.doi.org/ 10.1007/s12015-010-9117-6

Crossover Mixed Analysis in a Convergent Mixed Methods Design Used to Investigate Clinical Dialogues About Cancer Treatment in the Japanese Context

The convergent mixed methods design is a common mixed methods research strategy; however, a challenge arises when data are collected concurrently but not analyzed completely independently due to overlapping research aims or certain styles of reasoning. The aims of this study were to (1) implement a crossover-tracks analysis in a convergent design wherein qualitative and quantitative strands were intertwined and informed each other and (2) examine a working hypothesis about the relationship between temporal change in clinical dialogues to examine the strength of patients’ motivation to participate in a clinical consultation. Using hypothetico-deductive method, the dynamic analytical approach shifted between inductive and deductive approaches. The qualitative and quantitative results were merged, and a joint-display depicted the relation for the final interpretation.

The Japanese Generally Accept Human–Animal Chimeric Embryo Research but Are Concerned About Human Cells Contributing to Brain and Gametes

According to Kantor’s findings, the majority of Americans support human–animal chimera research, including the creation of human–animal chimeric embryos (HACEs) for disease studies and human–animal chimeras to grow organs for transplant to humans, whereas only about 20% oppose it [1]. His survey included questions on ethical issues concerning HACE research, that is, humanized animals in which human pluripotent stem cells transplanted to create human–animal chimeras contribute to brain and germline. The results revealed that among people who expressed support for such research, 77.4% supported studies in which brain contains human cells, and among those who opposed such research, 87.5% did not support the contribution of human cells to brain. These data have important implications for the formulation of future regulations. Between February and April 2016, we conducted a survey on HACE research (Supporting Information) [2]. Regarding the production of HACEs, 81.0% of the public and 92.4% of researchers indicated support. Regarding the production of human–animal chimeras, 64.5% of the public and 83.8% of researchers indicated support. Compared to Kantor’s findings, the results of this survey showed a high level of support for the production of HACEs and human–animal chimeras. The acceptance rates were higher than those of a survey conducted by Inoue and his colleagues (referred in Kantor) for the general public and researchers in Japan with respect to the production of HACEs with the purpose of producing organs for transplant [2, 3]. One possible reason for this difference is that the subjects were asked about their level of acceptance for various steps: HACE research was classified into three steps and the research objectives of each step were explained in detail (Supporting Information). Conventionally, ethical problems in HACE research, including concerns about whether human–animal chimeras will have human-like cognitive abilities, and, more recently, whether human–animal hybrids or humans will be produced, have been debated [4–8]. Therefore, in addition to the brain, which was included in Kantor’s survey, our survey also included six items related to liver, sperm/egg, skin, blood, and heart to gauge the level of acceptance for the inclusion of human cells in animal organs, tissues, and cells (Supporting Information). Similar to conventional ethical concerns, the results of our survey suggest that both the general public and researchers are more concerned about human cells in brain and sperm/ egg than in other organs or tissues (see Figure 1). Moreover, subjects were asked about acceptance for various degrees of human cells included (0%–100%) in each organ (Supporting Information). The results revealed that 48.5% of the general public and 45.7% of researchers never accept human cells contributing to the brain (0%), and 52.1% of the public and 74.3% of researchers never accept human cells contributing to the germline (0%). The survey results suggest the necessity of exploring measures to avoid issues regarding humanized brain and gametes in HACE research. HACE research is likely to be more widely accepted in the future by overcoming technological challenges along with the appropriate dissemination of relevant information.

Erratum to: Measuring motivation for medical treatment: confirming the factor structure of the Achievement Motivation Index for Medical Treatment (AMI-MeT)

Background Developments in chemotherapy have led to changes in cancer care in Japan, with the government promoting a transition to outpatient chemotherapy. This requires patients and their families to participate more actively in treatment than in the past. However, it remains unclear how patients’ motivation for medical treatment affects clinical consultations with their physicians. To investigate this, we developed a psychological index called the Achievement Motive Index for Medical Treatment (AMI-MeT), which comprises self-derived achievement motivation (AMS) and achievement motivation derived from others (AMO). However, its factor structure has not yet been confirmed in populations other than healthy university students. Thus, the aims of this study were to confirm the factor structure of the AMI-MeT in other groups and to determine the convergent and divergent validity of the AMI-MeT.