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.”