Latest Activities

First Preview Screening of our ME Documentary Film on October 22

We are very pleased to announce the first preview screening of our documentary film “Hope to these Hands: The Reality of ME/CFS,” produced and directed by filmmaker Seiji Arihara, at the TKP Shinagawa Conference Center Banquet Hall in Tokyo on October 22 at 1:30 p.m. (details below). “Hope in These Hands,” filmed between 2014 and 2017, is the first ME/CFS documentary to be produced by a patient association in Japan. We hope the film will be widely viewed both by medical professionals and the public.

Known mostly as “chronic fatigue syndrome” in Japan, ME/CFS has been called “myalgic encephalomyelitis” for 60 years, and is widely recognised as a neurological and immune disease internationally. While a recent Ministry of Health survey revealed that approximately 30% are severely ill patients who are close to bedridden, the situation of patients in Japan has remained hidden from society as they are rarely able to leave their homes. While it is still rare in Japan to find a doctor who can diagnose the disease, medical scientists around the world are now competing and collaborating with each other to advance research and to identify effective treatments.

After the screening, Dr. Takashi Yamamura (Director of Immunology at the National Center for Neurology and Psychiatry),  a leading researcher and clinician on neurological and immune diseases who has started research on ME/CFS over the last two years, will give a talk about the current state of international ME/CFS research. Seisa University Vice President and former JMEA board member Dr. Miwako Hosoda will speak about patient advocacy, including about the activities of our Association.

Venue and Registration

Date: October 22 (Sunday) 13:30 – 16:30

Venue: TKP Shinagawa Conference Center, Banquet Hall 6G (one-minute walk from the JR Shinagawa Station Takanawa Exit)

The event is free of charge and open to all members of the public (seats: 80 persons; please register in advance by email to Japan ME Association (answertomecfs@gmail.com) with your name, affiliation, and phone or email contact information).

Event Program

Part 1: Film Screening, “Hope in these Hands: the Truth about ME/CFS” (60 minutes; Seiji Arihara, Director)

Remarks: Mieko Shinohara (President, Japan ME Association): The documentary film “Hope to These Hands: The Reality of ME/CFS”

Part 2: Discussion and Exchange (Q&A session)

Dr. Takashi Yamamura (Director of Immunology, NCNP)

Dr. Miwako Hosoda (Vice President, Seisa University; former board member of Japan ME Association)

Democratic Party Hosts Study Group on ME/CFS

The Democratic Party’s Disability/Intractable Disease Policy Promotion group held a study group on ME/CFS at a conference room in the House of Representatives Building on May 11, 2017. The objective of the study group was to discuss ways to help bring relief to patients. 14 Democratic Party Diet members as well as the Secretaries to 23 additional Diet members attended.

With Representative Yasuko Komiyama serving as moderator, group chairman Representative Kazuhiro Haraguchi said in his opening remarks that when he disclosed [his] intractable disease osteogenesis five months ago, what surprised him was how many people are suffering, and that the study group would “give a voice to those who do not have a voice.” Japan ME Association president Mieko Shinohara then gave brief remarks, reading our request letter, and delivering the letter to Mr. Haraguchi. 

House of Councillors member Ryuhei Kawada said, “When I met Ms. Shinohara six years ago, we discussed the name “chronic fatigue syndrome” made it difficult to understand the disease. The disease is now being researched as a neurological disease, and it is classified as a neurological disorder by the WHO. A therapy called rituximab may be emerging. We’d like study this disease as myalgic encephaloymelitis so that we can create a system where research advances may be made.”

Next, National Center for Neurology and Psychiatry (NCNP) Director of Immunology Dr. Takashi Yamamura provided an informational brief to the group as a medical specialist. Dr. Yamamura is a neurology specialist who has treated and researched multiple sclerosis (MS). He explained how, having received a request from the patient association to use the technology and learning at NCNP to treat this disease, “[we] began research and seeing patients with the belief that we have to do this. One problem of this disease is that patients may not be properly diagnosed at a hospital because abnormalities do not show up on current standard medical tests. Hospitals handle this by telling the patients that there are no abnormalities or that they should visit another hospital because they may be suffering from a psychiatric illness. It is a miserable situation, which is why I believe we must develop an objective diagnostic method.” 

Dr. Yamamura explained the state of ME research, indicating that there is increased focus on abnormalities in the brain, including a PET image study indicating inflammation in the brain. Various diseases of inflammation should be treatable using drugs to effectively suppress inflammation. US patients advocated for research and the US National Institutes of Health (NIH) is investigating the disease with the US government increasing the amount of funding. Oncologists in Norway have published two papers in which the cancer drug rituximab had a significant benefit for about 60% of patients. The issue is how to move forward in this research context. Rituximab is a drug that kills tumors of lymphocytes called B cells and is thought to be a drug that modifies the immune system, and the possibility of using immune modulators for ME is something that is discussed by many scientists overseas.

Dr. Yamamura explained his experience with treating the disease optic nerve myelitis, a disease where severe fatigue is a symptom. Inflammation occurs in the eyes and the spinal cord and fatigue is severe. He explained that in optic nerve myelitis, where the inflammatory substance IL6 is elevated in patients, drugs used for rheumatoid arthritis led to dramatic improvement of fatigue symptoms in these patients. Fatigue is closely related to the immune system and it is important to focus on the immune system.

Many of the ME patients examined demonstrated immune abnormalities. Detailed analysis of patients’ lymphocytes using state-of-the-art flow cytometry technology has shown some of the B cells with clear abnormalities. Since the drug rituximab targets B cells, it is consistent with rituximab being effective. There is a need to shift gears from conventional fatigue research to research for treatments that target the immune system, and there is momentum in this direction globally.

On June 14 there will be a meeting of the Federation of Clinical Immunology Societies in the United States, and the NIH has organized a special four-hour symposium. There will be a session to study information with other researchers on immune abnormalities in myalgic encephalomyelitis and Dr. Yamamura would participate; there was momentum, and he appealed to the study group that he wanted to bring relief to patients as soon as possible.

Japan ME Association president Mieko Shinohara gave brief remarks. She recounted that “I had an onset of ME while studying abroad in the United States in 1990, by 1992 I already knew that I had brain abnormalities by MRI, an immune modulating drug called Ampligen was being tested since 1988. The disease has been treated as the neuro immune disease in Western countries. The NIH study used the Canadian Consensus Criteria as the basis for its research, a document that points to the WHO’s classification of the disease as a neurological disorder, as with the clinical guidelines issued by the IACFS/ME in 2012. It is common knowledge in the West that the disease is a neuro (immune) disease.”

She also mentioned that the phase III trial study of rituximab being conducted in Norway would conclude in October, with patients all over the world awaiting the results. There are many patients who have been ill for 20-30 years. The Ministry of Health survey made clear that 30% of patients in Japan are severely ill patients who are bedridden or close. The patients want more than anything to get better and to have clinical trials proceed. We ask that politicians and Ministry of Health officals understand the situation that patients are in and to act in a way that brings relief to their suffering.

After showing the trailer for the documentary that the Association is filming, Mr. Hiraiwa from the Ministry of Health explained the current intractable disease law and reported on ME/CFS research so far.

A lively question and answer session followed. Among the questions asked were whether Japan would be ready to test rituximab if the Norwegian study published positive results; whether there was evidence of infectious disease in light of historical outbreaks; whether there were neurologists prepared to conduct clinical drug trials; whether a specialized outpatient practice at NCNP could be established; whether the disease could be designated as an intractable; and why ME and CFS were described together. Dr. Yamamura explained that if there is a positive study result for rituximab in Norway and it is approved for clinical use, information would need to be submitted by the drug maker to the Japanese review agency PMDA before it could be used in Japan; that while in many cases a virus has been involved in triggering the onset of ME, the abnormality of the immune system continues but there is no increase in the triggering virus in the patient’s body; and that the name ME/CFS is being used for official purposes. The Ministry of Health Disease Control Division expressed that the ministry would continue to consult with Dr. Yamamura and work together with the patient association.

Representative Yasuhiro Nakane gave closing remarks. “We would like to firmly understand the wishes of the patient association. The budget has been an obstacle in medicine and administration generally, but it is the role of politicians to do something. Please accept our best wishes as we work under the leadership of Mr. Haraguchi.”

The Japanese National Diet Adopts the Association’s 2016 Petition

We are very happy to report that both Houses of the Japanese National Diet adopted of Japan ME Association’s 2016 petition during this year’s extraordinary Diet session. With our last petition adopted by the House of Councillors in 2014 and by the House of Representatives in 2015, success on our petitions at the legislature for the third year in a row is a truly remarkable achievement. Our petition was the only one adopted by the House of Councillors’ Health, Labour and Welfare Committee during this Diet session and just one of two adopted by the House of Representatives.

Thanks to the hard work of many, 105 bipartisan Diet members across seven political parties and two independent Diet members agreed to introduce the petition, and we gathered nearly 14,000 signatures. The signatories included not only patients and their families, but people who learned about ME for the first time through the petition who wished to help improve the situation of patients. We express our heartfelt gratitude to everyone. The petition will be delivered to the Cabinet, and the Cabinet will issue updates on the petition items to the House of Representatives approximately twice annually.

We believe that our October international academic symposium (supported by the Ministry of Health and Japan Medical Association, sponsored by the Nippon Foundation, and where the President of the Japan Neurology Association gave remarks) had a positive impact on the petition’s adoption. We continue to hope for advances in research for ME by specialist researchers, the establishing of a national medical system where ME patients may receive medical treatment, and for research into effective treatments for the disease similar to that which is being conducted abroad. We thank you in advance for your continued support towards these important goals.

The Liberal Democratic Party ME/CFS Caucus Holds General Meeting

On November 15th, the ruling Liberal Democratic Party’s (LDP) of the Japanese National Diet held a general meeting of its new caucus on behalf of ME/CFS patients at the House of Representatives. The caucus seeks to realize the designation of ME/CFS as an Intractable Disease and to promote research to elucidate the cause and pathology and to develop effective treatments; it was formed as the result of meetings between Japan ME Association and LDP members.

18 LDP members were responsible for establishing the caucus, with 22 LDP Diet members and 14 Secretaries to Diet members attending the meeting (five other members unable to attend). Four Ministry of Health Disease Control Division officials and two Department of Disaster Health and Welfare Department Planning Section officials also attended.

The Asahi Shimbun, The Yomiuri Shimbun, Kyodo News, and various specialist media outlets provided media coverage of the meeting.

As the leader of the caucus, House of Representatives member Yuya Niwa opened the meeting. (Mr. Niwa previously served as Minister of Health in the Miyazawa, Obuchi and Mori cabinets.) He stated, “This disease is an acquired, severe illness where the neurological system affects the entire body and 30% of patients are close to bedridden. Despite its severity, it has been excluded from being designated as an intractable disease, and patients currently face social and economic hardship. We establish this caucus to change the current situation, in which there are few doctors who can diagnose the illness and diagnostic criteria are not yet established, so that we can provide hope to patients.” Representative Niwa took office as chairman, and executive officers were appointed.

The head of the Ministry of Health’s Department of Disease Control  briefed the group on current measures for intractable diseases and the results of the 2014 ME/CFS national patient survey, and expressed the Ministry’s intent to continue to support further research efforts.

Next, Dr. Takashi Yamamura, Director of Immunology at the National Center for Neurological Disorders Research (NCNP), spoke about how to approach this disease from a cutting-edge research technology perspective. Dr. Yamamura, a leading neurologist who has researched and treated multiple sclerosis (MS) for 25 years, became interested in ME/CFS and has begun research on the disease. 

He stated, “The name chronic fatigue syndrome does not accurately reflect this disease. It is important for you to understand that it is not merely an extension of fatigue, but to understand the disease as an independent disease, especially as misunderstanding is reinforced using this name.”

“There are many patients who need to rest lying down for more than half of the day, which is a serious situation. It is my feeling that if it’s possible to treat this disease, we must treat it as soon as possible. I know of a patient whose only nutrition is by IV drip, who weighs only 26 kilograms, and with the mother caring for the patient all day, unable to leave the home because anything can happen to this patient at any time. There are similar patients where home nursing care is being provided by family members for a disease that has not been recognised, and therefore cannot be treated at a hospital with health insurance. This situation must be understood.”

Dr. Yamamura further explained, “Studies have found inflammation in the brain; there is also data from Western countries which shows the brain atrophies over time. If  we do nothing to stop this, we will not be able to move forward in this disease and patients cannot be saved.” He informed the caucus that in the United States NIH announced its own research study on the disease in 2015 and that research in Europe is currently a focus of attention, where Norwegian patients with ME and malignant lymphoma experienced improvement of ME symptoms when the cancer drug rituximab was administered. In addition to being used in lymphoma, Rituximab is used in vasculitis, multiple sclerosis, and other immune-related disorders, and it could prove to be effective for ME. The Norwegian doctors are conducting clinical trials, and the results are being closely followed by the NIH and the United States. There is a focus on the possibility of using immune-modulating drugs to treat the disease.”

He discussed the importance of looking for targeted therapies, stating “…in treating AIDS, doing research on fatigue, which is just one of the symptoms, would not have been effective “upstream” to arrive at a treatment. AIDS became a disease that could be suppressed as a result of finding the virus. It is important to target the therapy. One example where we succeeded in doing this is in the intractable disease optic nerve myelitis. We found that inflammatory substances called IL-6 were increased, so we used a drug that blocks IL-6 and patients improved. Optic nerve myelitis is also a disease with relapsing symptoms. As with ME, patients would be in bed for a week after the exertion of coming to the hospital. But when we blocked the right target, this improved. There are data in ME/CFS where inflammatory substances such as IL-6 and IL-1β have been indicated. I believe it is important to look for targeted treatments: not toward the periphery (relieving symptoms such as fatigue), but more upstream (fundamental therapy).”

“Many people with ME who have come to our hospital have a surprising co-morbidity of immune disorders. We are now investigating lymphocytes that are killed by the anti-cancer drug rituximab using very advanced technology. We think the drug used in optic myelitis may be a candidate in this disease. It is critical that we understand this not as a fatigue disease, especially in light of the disease concept being conflated with the emphasis on the fatigue symptom. We need funding to research targeted immune therapies. Moreover, to do this, we must involve specialists who understand brain inflammation (neuroimmunology specialists). The optic neuromyelitis research had demonstrated succcess at just 4 years. So we must not think that just because a disease is an intractable disease that it will take a 10 or 20 year span [to resolve it]. If a good drug treatment has the potential to improve patients in 3 years, we should not be delaying it to take 10 or 20 years.”

A lively question and answer session followed. Questions from the Diet members included: “When will the diagnostic criteria be established?” “Why is this disease not designated as an intractable disease?” “What are the obstacles of having it designated and how can they be solved?” ” Are there objectives for the diagnostic critera other than to identify a new biomarker?” “What are ways we can help patients with the social and economic burden of their daily living activities?” 

Japan ME Association president Mieko Shinohara also spoke at the meeting. “We wonder why, in a disease that has been classified as a neurological disorder by the WHO for 50 years, neurological research hasn’t occurred until recently. Last year, the United States NIH announced a research study where its neurological section is the lead investigating section. The Canadian Consensus Criteria, which our Association translated into Japanese as our first priority, was used for the NIH study. At our academic symposium in October, the president of the Japan Society for Neurology stated that neurologists would like to become involved in research. We believe research in Japan should be on par with the caliber of research which is occurring internationally.”

She further stated, “With ALS and systemic lupus, there are no single biomarkers, and the combining of several different test results is approved as objective diagnostic criteria by the Health Ministry. Please understand that there effective drug treatments could arise in three or four years and that some patients may be able to return to work. Our organization’s efforts to this end have received the support of the heads of the Japan Neurology Society and the Japan Medical Association. We ask for the help of Diet members and the Health Ministry to support serious research for this disease.”

Finally, Mr. Niwa commented, “Having listened to today’s speakers, I feel that I must work hard as the leader of the group towards solving this problem. We as politicians would like to have the group be a source of hope as we work to establish treatments and have patients return to participating in society as soon as possible.”

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

takahashidrOpening 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.

komaroffInternational 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.

klimasIn 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.

yamamuraDr. 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.

tendrDr. 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.

klimaskomaroffThe 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

 

 

March 11 Meeting with Intractable Diseases Control Division

3.16 meetingOn March 11, JMEA met with the Ministry of Health’s Intractable Disease Control Division Section Chief Matsubara and assistant chiefs.

JMEA discussed the February 16, 2016 presentation at the U.S. CDC entitled “Post-infectious Chronic Fatigue Syndrome: Intramural Research at the National Institute of Health.” According Dr. Avindra Nath, the study’s Principal Investigator and chief of the National Institute of Neurological Disorders and Stroke (NINDS) section on infections of the nervous system, NIH’s study will focus on ME patients who had acute infectious onsets of ME. The presentation mentioned the recent Norwegian research on clinical trials of Rituximab as a treatment for ME.

JMEA appealed to the Ministry officials that Japan not fall behind other countries by advancing research on ME as a neurological disease in Japan, including allocating funds for clinical drug trials.

We learned at the meeting that while the United States apparently classifies both Ampligen and Rituximab as immune-modulating drugs, Rituximab is classified as a molecule-targeting drug in Japan.

Fundraising for Documentary Film on ME in Japan

Over the past two years, filmmaker and JMEA board member Seiji Arihara has been filming ME patients in Japan, depicting the daily reality of patients for a documentary film on ME in Japan, scheduled for completion in the spring of 2017.

We are currently raising funds to cover production costs for the film, and have created a short promotion video here. We ask for your help to circulate the video and encourage others to donate what they can so that we can make the best documentary possible.

The film will convey the difficult medical, financial, and social situation faced by ME patients and the complex problems surrounding ME, including the current “chasm in the (government) system” in which ME patients do not have access to public disability support and services under the current disability law. We would also like to portray the steadfast efforts of patient advocates and dedicated researchers and clinicians to improve the current situation despite these systemic problems.

Most of all, our goal is to raise accurate awareness about ME to improve the current state of medical care and to encourage new research for the disease.

ME remains virtually unknown in Japan, even with the Ministry of Health’s report from the 2014 ME/CFS patient survey revealing that 30% of patients are bedridden or close, most without access to reliable medical care. Patients and their loved ones continue to suffer from a lack of understanding about the severity of the illness from the medical profession, government health agencies, and society.

We kindly ask for your contribution to make the best film possible.

Donations can be made by bank transfer (within Japan) to the following accounts, created especially for the documentary film.

For donations from Japan Post Bank accounts:
– Japan Post Bank
Code: 10040 Number: 9222542

For donations from all other Japanese banks:
– Japan Post Bank
Branch Name: 008 Branch Number: 008
Regular Account: 9222542
Tokutei hieirikatsudohojin kintsusei nousekizuien no kai