Awareness – Japan ME Association

International Release of Documentary on ME in Japan (VIMEO)

Japan ME Association is pleased to announce the international release of “Hope to Our Hands: The Hidden Story of ME/CFS in Japan,” an English-subtitled version of our documentary film on ME patients in Japan. It may be streamed or downloaded on VIMEO here.

Originally created to raise awareness among government health policymakers and the general public in Japan and screened domestically since its completion in 2018, the new English-subtitled film (produced from an abridged version targeted to Japanese medical professionals) brings the film to an international audience for the first time.

The situation of Japanese ME/CFS patients has long been unknown outside Japan. Most Japanese patients lack the English skills to access online information from abroad. Amidst this isolation, the Japanese government and medical profession have continued to neglect the disease as a “fatigue” illness with psychogenic factors for the past 30 years. It is also the story of Japan ME Association, founded by Mieko Shinohara, who fell ill with ME while studying abroad in the United States, and patients’ efforts to create much-needed change.

Recommended by the Japan Medical Association president and the former Japanese Society for Neurology president and receiving the strong support of patients and doctors alike, it is our hope that in sharing the documentary, Japan can begin to join the international ME/CFS community to advocate for patients’ lives.

Concerns regarding the Japanese Ministry of Health’s Fact Sheet on ME

Japanese legislators rely on the Japanese Ministry of Health for accurate and current information on diseases. For this reason, our Association was deeply concerned when we discovered (on February 7, 2019) the fact sheet on ME/CFS that the Ministry of Health currently distributes to Japanese legislators who request information from the Ministry to learn about the disease.

Presented in a one-page fact sheet, the information (translated below) contains careless inaccuracies which combine to depict ME/CFS as a mild condition with psychiatric components. It is careless and misleading in what it includes and what it excludes: ME/CFS is summarized as a list of symptoms that any healthy person might have: chronic malaise, fatigue, headaches, and cognitive dysfunction. The list notably includes depression, which is not a symptom of the disease, while it excludes the hallmark ME symptom of post-exertional malaise—the prolonged worsening of physical and cognitive function following physical or cognitive exertion.

Further, the fact sheet prominently lists several psychiatric conditions as “co-morbid symptoms” in the second sentence of the short document. We are concerned that taken together with the mention of antidepressants and psychological therapy in the treatment section of the document, any individual relying on this fact sheet alone would conclude that ME/CFS is a mild condition with psychiatric components, misrepresenting both the medical literature about the nature and severity of the illness and reflecting a denial and disregard for the lived reality of ME patients.

The fact sheet surprisingly makes no mention of the Health Ministry’s own 2014 ME/CFS Patient Survey, which found that approximately 30% of ME patients in Japan are severe patients who are bedridden or close and require assistance with activities of daily living and that moderate and severe ME/CFS patients are unable to work.

The fact sheet also conveys the incorrect impression that the illness was first reported in 1988, omitting information about earlier reports which led to its classification in 1969 as a neurological disorder in the WHO International Classification of Diseases.

The following is an English translation of the fact sheet in its entirety:

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

(1) What is ME/CFS

(1) Summary

A syndrome where patients are affected by severe generalized malaise of unknown cause followed by strong fatigue along with symptoms such as mild fever, headache, muscle pain, a feeling of exhaustion, cognitive dysfunction, and depression which continue over a long period. Comorbid symptoms include mood disorders, somatic symptom disorders, anxiety disorders, fibromyalgia, and irritable bowel syndrome.

Chronic fatigue syndrome is a syndrome that was reported by the United States Centers for Disease Control in 1988 (Chronic Fatigue Syndrome: CFS). In the United Kingdom it was also called myalgic encephalomyelitis (Myalgic Encephalomyelitis: ME) but in recent years it is being said that these might be the same syndrome.

(2) Cause

The involvement of infectious disease, immune function abnormalities, autonomic nervous system abnormalities, and endocrine abnormalities have been suggested but the cause is unknown.

(3) Diagnostic criteria / Treatment

At present no diagnostic criteria which uses objective markers has been created in any country. Vitamins, antidepressants, Chinese herbal medicine, and psychological therapy are being tried, but no effective treatment methods have been established.

Status of the 2017 Proposed ME/CFS Treatment Guidelines (Draft)

In late 2017, JMEA submitted its opposition to the publication of national ME/CFS treatment guidelines for Japan (Draft), which was scheduled to be published in spring 2018. The document was not published in spring 2018 but was set to be filed as a research report with the government health agency Japan Agency for Medical Research and Development (AMED). We are currently awaiting the release of this report and will provide a further update on the research report when it becomes publicly available.

The Association is deeply grateful to the international ME/CFS medical experts and advocacy organizations which kindly responded to our request to provide comments on the draft treatment guidelines document. We immediately shared your comments with the research committee which drafted the document and with the Ministry of Health.

In August 2018, we held a press conference at the Ministry of Health on the opinion letter we received from the International Association for CFS/ME (IACFS/ME) in response to our request for the association’s opinion on translated excerpts of the document. In the opinion letter, the IACFS/ME expressed concern that the document could be of potential harm to ME/CFS patients in Japan due to the recommendation of Graded Exercise Therapy (GET) as an effective treatment. The letter also shared our concern that the discussion in the document of behavioral interventions such as Cognitive Behavioral Therapy and yoga and of antidepressant drug therapy could give the mistaken impression that ME is a psychological illness which can be cured by such interventions. Questions from the press included why the opinions of the international and Japanese ME/CFS experts differed, among more specific questions about the document.

Japanese National Diet Adopts JMEA’s 2018 Petition for ME/CFS Research

We are pleased to announce that the Japanese National Diet has adopted Japan ME Association’s 2018 petition to the national government, “Petition Seeking Research Advancement for the Neurological Disease ME/CFS,” as a result of voting on the petition by the House of Representatives and the House of Councillors, respectively. The adoption of our most recent petition follows the successful adoption of our formal petitions to the Japanese national legislature in 2014 and 2015, and again in 2016.

The petition was introduced to the 2018 Diet session by 99 Diet members across multiple political parties and submitted with more than 13,500 signatures. We are deeply grateful to all of the individuals (which included not only patients but those who first learned about ME/CFS through the petition effort) and Diet members who generously contributed to this significant result.

The petition will now be delivered to the Cabinet, and the Cabinet will produce approximately two reports annually to the House of Representatives on progress on the petition items.

ME/CFS has been classified in the World Health Organization’s International Classification of Diseases as a neurological disorder since 1969, and the disease has again been classified as a neurological disorder in the revised ICD-11 announced on June 18, 2018. This past April, AMED (the Japan Agency for Medical Research and Development) adopted the neurologist Dr. Takashi Yamamura’s research team for ME/CFS. ME/CFS was also featured in the scientific publication Nature this year, indicating that the disease is now recognized at a global level.

Japan ME Association greatly appreciates your continued support as we advocate for ME/CFS to be designated as Intractable/Rare Disease in Japan and for research advancements that will bring much-needed effective treatments to ME/CFS patients.

JMEA signs Letter to WHO Director-General Dr. Tedros Adhanom Ghebreyesus

As part of our collaborative actions with international ME advocacy organizations along with our participation in the global day for health equality for ME/CFS #MillionsMissing, Japan ME Association has co-signed an open letter to the WHO Director-General Dr. Tedros Adhanom Ghebreyesus from the International Alliance for ME requesting a meeting to highlight the serious and significant impact of ME and to “explain why we are seeking urgent national and international action to increase research on [ME] and ease the suffering of patients around the world.”

We support this letter along with ME advocacy organizations from the UK, the United States, Australia, South Africa, Spain, and other countries in our sincere hope that the Director-General will accept the International Alliance’s invitation to speak with him to address the urgent situation facing ME patients worldwide at the WHO level. The full text of the letter can be found here.

JMEA to participate in #MillionsMissing at Geneva Event

On Saturday, May 12, 2018, Japan ME Association will participate in the global #MillionsMissing protest as part of the International Alliance for ME’s Visibility Event at Place Des Nations in Geneva, Switzerland, the location of the World Health Organization (WHO).

#MillionsMissing is a global day of public action that calls for health equality for patients with ME. This year, Japan ME Association joins for the first time through its participation in the event in Geneva, where messages from Japanese ME patients will be displayed among those from many other countries. The International Alliance for ME is a joint international advocacy movement which aims to raise the profile and awareness of ME at the WHO level. The goal of the Alliance is to collaborate with organizations and individuals at the national and international levels to advocate for the adoption of a resolution by the WHO and its Member States recognizing ME as a “serious, chronic, complex and multisystem disease that frequently and dramatically limits the activities of affected patients (Institute of Medicine, 2015)” and to adopt measures to provide a global and coordinated public health response to ME.

JMEA believes that it is critically important to combine our efforts with ME advocacy organizations internationally to more effectively convey to the Japanese government the urgent need to improve the current public health response to ME. We firmly believe that advances at the WHO level and in other countries will positively influence the situation of ME patients in Japan and vice versa.

Public Comments on the Proposed Treatment Guidelines

In December 2017, in addition to requesting an external review from Japan ME Association among other groups on its “ME/CFS Treatment Guidelines for Japan,” the Research Committee on the Development of Treatments and Treatment Guidelines for ME/CFS also solicited comments from the public.

Several organizations and individuals within Japan have shared with us the public comments they submitted to the guidelines research committee. We highlight three of them (translated from the original Japanese) here.

“According to a 2012 to a survey conducted with the ME/CFS association, 47% of patients visited more than six medical institutions before they obtained a diagnosis. Patients struggled from misunderstanding and prejudice even after receiving an ME/CFS diagnosis, with a lack of understanding from family and friends. They are often viewed as being malingerers. The proposed guidelines include many problems as the patient association has indicated, and will result in further deepening misunderstanding about the disease among medical professionals who do are not familiar with ME/CFS. I hope these guidelines can be reconsidered using reliable factors such as diagnostic criteria and clinical treatment information.” – Dr. Miwako Hosoda, Vice President, Seisa University
“What patients seek regardless of where they live is discovery of the pathology of ME/CFS and the development of effective treatments. It is unacceptable to have situations that may result in harm to patients even outside the context of clinical treatment. This is because the suffering that accompanies illness onset, diagnosis, and visiting doctors in search of treatment is endured by patients and their families, and more precisely, by patients. Of course, risks accompanying research such as clinical treatment trials may be unavoidable. But such risks must be minimized as much as possible, not just limited to clinical trial research… At the very least, I am uncomfortable with the release of the current proposed guidelines, which have been created without convening a panel consisting of stakeholders such as patients, members of the public, and specialist researchers.” – Natsuko Nojima, Researcher, Japan Society for the Promotion of Science
“In treating illnesses like ME/CFS where the pathology is not yet known, it is only with the passage of time when the actual situation becomes known that medical treatment and medical policies may be truly evaluated. For example, there could be a treatment that may be applied with the best of intentions, but which could constitute a human rights issue. There is a need to be cautious. If there is no treatment with an A-grade recommendation, I believe the guidelines should make clear that there are currently no effective treatments. Since there is no such statement, many clinicians may overlook this important fact and may select graded exercise therapy, which is recommended as a B-grade treatment but has the potential to make patients worse. It could spread the promotion of exercise for illnesses with fatigue even if they make patients worse, as these incidences often remain unreported and patients may end up paying for treatment only to find themselves suffering more.” – Keiji Nakazawa, President, Non-Profit Organization Healthcare Innovation in Japan

Accolades for our Documentary Film

Japan ME Association was honoured to receive words of recommendation for our documentary film, “Hope to these Hands: The Reality of ME/CFS,” from Japan Medical Association and World Medical Association President Dr. Yoshitaka Yokokura on December 17. We would like to share his kind words (translated from Japanese):

“Congratulations to Director Seiji Arihara and Japan ME Association for the completion of the film ‘Hope to these Hands: The Reality of ME/CFS.’ This work carefully encompasses not only the symptoms of this disease, but other dimensions of the reality of the illness surrounding the patients, such as the inability of patients to obtain Disability Certificates and the activities of the patient association, including from the voices of the patients themselves. It is a film that should be seen not only by medical professionals, but by the general public. There are indications of hope for patients in the recent efforts of researchers around the world to develop treatments. It is my hope that by having as many people as possible view the film, a deeper understanding of the illness and advances within Japan concerning the development of diagnostic criteria and the drafting of guidelines will result. The Japan Medical Association, in our capacity, would like to continue to assist in these efforts.”

On December 13, we also received the following generous words from the Japan Council on Disability (JD) president Katsunori Fujii (translated from Japanese):

“One wonders why, while patients [at large] experience similar suffering to live, there are such differences in the way government administration treats them. Through images and the voices of patients, the film conveys the reality and practical difficulties of the patients’ situations from a perspective that is both human and objectively critical. We encourage as many people as possible to see this film, and to host voluntary screenings of the film.”

Finally, Japanese Society of Neurology President Dr. Ryosuke Takahashi (Professor, Kyoto University School of Medicine) appears in the film and has also expressed his recommendation of the film.

An Outstanding Preview Screening of our ME Documentary Film

Japan ME Association hosted our first preview screening of “Hope to these Hands: The Reality of ME/CFS,” our original documentary film depicting the situation of severely ill ME/CFS patients in Japan which we began filming in 2014, at the TKP Shinagawa Conference Center in Shinagawa, Tokyo on October 22, 2017. Despite rain from a typhoon, many people turned out for the event for an outstanding premiere of the film. We are deeply grateful to everyone who attended, as well as to those who worked tirelessly to raise funds to make the film possible.

With JMEA board member Dr. Isu Shin, M.D., Ph.D., moderating, JMEA President Mieko Shinohara thanked Director Seiji Arihara for making the film and expressed that the objective of making and screening the film before audiences in Japan was to raise accurate awareness about ME and to advance research for the disease.

Mr. Arihara then gave a candid introduction to the film, revealing that when he and Ms. Shinohara first produced a Japanese-subtitled version of the American documentary film “I Remember Me,” many years ago with director Kim Snyder’s permission, he had never imagined that he would one day make a Japanese documentary about Japanese ME patients. He explained that making the film required acquiring a deep understanding of the day-to-day reality of the disease. He also expressed his gratitude to the many patients who agreed to be filmed but who did not appear in the final version of the documentary.

The film depicts patients who are severely ill with ME amidst a society that does not recognize the illness, the social and financial consequences of patients’ inability to obtain Disability Certificates, our patient association, and finally, the hope from recent research developments in the US and other countries to develop effective treatments.

We received immediate feedback on the film after the screening: “Thank you for making this film.” “The film captured patients’ thoughts and troubles concisely.” “It was encouraging to learn about all the research being done in the United States.” “I was happy that the film makes clear that ‘stress’ is not the cause of the illness.” “I felt encouraged to overcome the difficulties that I experience.” “The film achieved a balance between subjective patient experiences and objective information.” “I want the severely ill patients who couldn’t make it to the screening to see the film as soon as possible.”

After a short break, former JMEA Vice President Dr. Miwako Hosoda spoke about the remarkable journey of Japan ME Association’s efforts in engaging medical researchers, government policymakers, social scientists, other non-profit associations, and the media to improve the situation of patients’ lives.

Finally, Dr. Takashi Yamamura, Director of Immunology at the National Center of Neurology and Psychiatry (NCNP) gave a presentation entitled “Directions in ME/CFS Research.” Dr. Yamamura, a leading specialist in multiple sclerosis (MS) who is now also engaged in ME/CFS research, gave the example of developments in MS, where after 25 years of having no effective treatments, there are now around five drug treatments for the disease, with many patients able to work; when one drug emerges, the landscape can change dramatically within 10 years. Neurological diseases often are not detected by standard medical tests, as is the case with ME/CFS. He emphasized the importance of research on inflammation in the brain and central nervous system and about the potential for major research advances in Japan; Japan should not merely depend on research from the US and Europe, especially with the high quality of Japan’s immunological research, with research institutions equipped with advanced technology on par with research universities abroad. He also discussed the importance of detecting the disease early in patients going forward, and the possibility of using existing drugs to treat the disease.

Finally, we answered questions from the press, including how we planned to make use of the documentary to spread awareness in Japan, whether the name “chronic fatigue syndrome” would change, and what steps were necessary to obtain adequate funding to advance medical research.

An Outstanding ME/CFS International Academic Symposium

On October 23, 2016, the Association co-hosted an international academic symposium, “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Towards Effective Treatments for ME/CFS as a Neuro-Immune Disease” at the Tokyo University Tetsumon Memorial Lecture Hall, where we welcomed Dr. Anthony Komaroff and Dr. Nancy Klimas from the United States as special guest speakers.

The symposium aimed to raise accurate awareness among Japanese medical professionals and to stimulate interest in new neuro-immune research in Japan for ME, which is categorized by the WHO as a neurological disorder (ICD-10 G93.3). More than 150 people attended the symposium, including over 50 medical professionals and 13 pharmaceutical company representatives, as well as members of the press and public.

symposium1

takahashidr Opening remarks were given by Dr. Ryosuke Takahashi, Professor of Neurology at Kyoto University Graduate School of Medicine. He stated that as President and representative director of the Japan Society for Neurology, “I have come to recognize our need to turn our attention to this disease,” and expressed his hope that the symposium would aid those in attendance to become knowledgeable and to eventually advance research for treatments for ME/CFS.

International ME/CFS expert and thought leader Dr. Anthony Komaroff (Professor of Medicine, Harvard University) delivered the symposium’s keynote speech entitled “The Biology of ME/CFS.” Dr. Komaroff emphasized that, as a 2015 United States Institute of Medicine report concluded after a review of over 9,000 medical studies, ME/CFS is a biologically-based illness with abnormalities affecting multiple systems. Dr. Komaroff’s presentation encompassed the definition of ME/CFS, epidemiology studies, neuropsychological studies demonstrating cognitive dysfunction, abnormalities found in brain studies including on MRI, SPECT, PET, EEG, and spinal fluid studies, post-exertion muscle abnormalities, immune abnormalities, the possible role of infections in triggering the illness, energy metabolism abnormalities, evidence of oxidative and nitrosative stress, and the possible role of the gut microbiome which may be triggering some cases of the illness.

JMEA President Mieko Shinohara gave a talk entitled “Our Journey to the Symposium,” in which she recounted the almost total isolation of ME patients when she first returned to Japan in 1996 (after becoming ill in the United States). She then described JMEA’s efforts to bring about change for patients in Japan since establishing the Association in 2008.

klimas In a presentation entitled “Modeling ME/CFS to Develop Targeted Therapy,” past IACFS/ME President Dr. Nancy Klimas (Director for the Institute for Neuro Immune Medicine, Nova Southeastern University) discussed the work of the interdisciplinary team at her institute to develop a virtual model of ME/CFS, integrating genomic, immune, endocrine, neuropeptide and clinical data in a dynamic modeling study. Dr. Klimas described progress on one study in which blood was drawn from research subjects at rest, during exercise to the anaerobic threshold, and 7 additional time points over 24 hours, with the computational biology team using the data to examine the sequence of events leading to relapse (post-exertion exhaustion), then “projecting back” to therapeutic targets that would prevent relapse. The modeling work is also used to look for strategies to reset homeostatic networks and for curative therapies. Dr. Klimas reviewed the study’s progress to date, including plans for eventual clinical trials. Dr. Klimas, an immunologist, emphasized that ME/CFS is a neuro-immune disease.

Dr. Takashi Yamamura (Director, Department of Immunology, Japan National Institute of Neuroscience, NCNP) presented “Towards Immunotherapy for ME/CFS: Flow Cytometer Analysis.” Dr. Yamamura noted that among immune abnormalities reported in ME/CFS, the therapeutic effect of B cell depletion by the drug rituxmab had been reported in studies from Norway in 2011 and 2015. He discussed the use of flow cytometer analysis in a study by his institute to examine the possible role of B cells in ME/CFS pathophysiology. The frequency of transitional B cells among total B cells was significantly decreased and that of CD80+ plasmablasts were increased in ME/CFS patients compared to healthy controls. This might suggest a subset of ME patients with a functional dysregulation of B cells, a possible therapeutic target.

tendr Dr. Chuwa Tei (Professor, Dokkyo Medical University) discussed the effectiveness of Waon therapy to relieve symptoms of ME/CFS. Dr. Tei developed Waon (“soothe warm”) therapy as a thermal therapy for chronic heart failure. He described clinical cases of ME/CFS where symptom relief was observed as the result of the therapy, which is characterized by improvement of vascular endothelial function, improved blood flow (including cerebral blood flow) through systemic blood vessel dilation, improved central and peripheral autonomic function, and promotion of antioxidant effects.

In his closing remarks, Dr. Yamamura stated: “ME/CFS will likely be examined as a disease at the intersection of neurology and immunology, and we are standing at the dawn of this research. We thank the patient association for organizing this symposium and it was remarkable that our prominent guest speakers from the United States gave such comprehensive lectures to the medical professionals here today.” A lively question and answer session among the symposium speakers and audience members followed. After the symposium, Drs. Komaroff, Takahashi, and Yamamura planned to co-write an article on neurological abnormalities in ME/CFS to be published in a Japanese neurology journal.

klimaskomaroff The symposium was a landmark event which brought together veteran ME/CFS scientists and leading Japanese neurologists to discuss ME as a neuro-immune disease, one which gave us hope for new research in Japan, including clinical trials to study potentially effective drug treatments.

The symposium was made possible by The Nippon Foundation, as well as the support of the Ministry of Health, Labour and Welfare, the City of Tokyo, Japan Medical Association, Japan Society of Neurology, National Center for Neurology and Psychiatry, Japan Physicians Association, The Japanese Association for Gender-Specific Medicine, Hodanren, Tokyo Medical Practitioners Association, Min-Iren, Japan Nursing Association, Japan Association of Medical Technologists, Japan Association of Social Workers in Health Services, Japan Council on Disability, and the Iryoseido kenkyukai. We would like to warmly thank the Tokyo University Graduate School of Medicine Neurological Science department and our dedicated volunteers for making the symposium such a success.

The symposium may be viewed here.

Nippon Foundation