Uncategorized – Japan ME Association

Trailer for “Hope to Our Hands: The Hidden Story of ME/CFS in Japan”

The Japan ME Association will produce an English-subtitled version of our documentary film about ME/CFS patients in Japan, “Hope to Our Hands: The Hidden Story of ME/CFS in Japan.”which we have been screening before a wide range of audiences across Japan since it was completed in 2018. We would like to introduce the trailer for the film (an English translation of the Japanese trailer follows below).

English translation: Trailer for “Hope to Our Hands: The Hidden Story of ME/CFS in Japan”

Text enclosed in brackets […] are captions (text on screen).

[Hope to Our Hands]
[The Hidden Story of ME/CFS in Japan]
[Trailer]

[One day, all of a sudden]
[Stricken by an illness without known cause or treatment]
[Becoming bedridden and forced to quit work or school]
[With most medical tests detecting no abnormalities]
[People with the illness are told despite suffering from severe symptoms
that it’s just their imaginations or that they’re lazy]

Woman: There are many doctors who have never even heard of the illness.

[An illness that doctors don’t know]
[A lack of doctors to write disability certificates without a diagnosis]

Woman lying in bed: When I met with those five patients, everyone was saying the same thing. Doctors don’t understand. Family members don’t understand. We’re struggling financially because we aren’t able to get disability assistance.

[Not recognized as having a disability]
[Unable to receive government support]

[Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS)]
[The illness has been called Chronic Fatigue Syndrome in Japan]
[Now it is common to use both names: ME/CFS]

Woman on sofa: People don’t take me seriously and say things like, ‘Oh, I have chronic fatigue, too.’ In the end, telling people the name causes even more misunderstanding about my illness.

[Suspected of being lazy or malingering]
[There are an estimated 100,000 patients]
[Patients who have been abandoned]

Woman in bed: When I realized that everyone was suffering the same way that I was, that they were all struggling, I realized that I had to do something.

[So she spoke up, created a patient association to raise awareness]

Title shot : “Hope to Our Hands: The Hidden Story of ME/CFS in Japan”

[Caption: Mieko Shinohara. Diagnosed in 1990 in the United States]

Woman in bed: I realized that Japan was really behind [Western countries].

[I want people to know about this devastating disease]

[Despite being trapped in a body that would not work the way she wished]
[She searched for other ME/CFS patients who would take action]
[From Hokkaido to Hiroshima]

Hope to Our Hands: The Hidden Story of ME/CFS in Japan

[Research for ffective treatments is being conducted overseas]

Woman wearing glasses: I hope they discover the cause and treatments for the illness soon.

[Completed this spring]
[Join our cause by hosting film screenings of this documentary across Japan]
[So that the truth about ME/CFS ]
and the voices of the patients can be heard]

Japan Me Association
Hope to Our Hands: The Hidden Story of ME/CFS in Japan
Seiji Arihara, Director

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.

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.”

March 11 Meeting with Intractable Diseases Control Division

3.16 meeting On 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.

JMEA Meets with Secretary to Special Advisor Seichi Eto

On February 8, 2016, JMEA held an hour-long meeting with the Secretary to House of Councillors member Seichi Eto, special advisor to the Prime Minister and head of the Investigative Committee for Disabled Children.

We requested Mr. Eto’s support for government funding of research on ME as a neurological disease. We discussed NIH’s ME/CFS study under the direction of NINDS, mounting global opposition to the 2011 Lancet PACE study, ongoing clinical drug trials for the treatment of ME in other countries, and new research being started in Japan in cooperation with the Association. We further urged that the “Chronic Fatigue Syndrome” disease name to be changed in Japan, explaining that that name has perpetuated the erroneous view that the disease is merely an illness of chronic fatigue.

We informed Mr. Eto’s Secretary about our meetings with the Minister of Health and the president of Japan Medical Association with our requests for increased ME research.