Advocacy – Page 2 – Japan ME Association

Cabinet Report on JMEA’s 2015 Petition

Following the national government’s adoption of JMEA’s petition for public assistance for ME last fall, we will be receiving reports from the Cabinet on our petition items approximately twice annually.

We received the first such report from the Cabinet with the subject line “Petition Concerning Assistance for Myalgic Encephalomyelitis,” with the Ministry of Health, Labour, and Welfare designated as the main responsible ministry. The report contained updates on our two petition items (for the establishing of diagnostic criteria and for inclusion in the Act on General Support for Persons with Disabilities) as follows:

(1) A research team commissioned by the Japan Medical Research and Development Agency is conducting research on discovering the cause of the disease and developing diagnostic criteria and treatments.

(2) The existence of objective diagnostic criteria for a disease is a prerequisite for the disease to be eligible to receive support such as disability welfare services under the Act on General Support for Persons with Disabilities. We are about to initiate a review of eligible diseases, building on our ongoing review of diseases designated as Intractable Diseases under the Intractable Diseases law. In the event diagnostic criteria containing objective markers for ME/CFS is established, we would like to consider the inclusion of ME/CFS as a disease eligible to receive disability welfare services under the Act, including from the perspective of the actual need for public assistance.

Meeting with the Intractable Diseases Control Division

On December 9, 2015, we met with two assistant section chiefs of the Ministry of Health’s Intractable Diseases Division (the new name of the Specific Diseases Division effective October 1, 2015), where we submitted our most recent letter to Minister of Health Yasuhisa Shiozaki.

We reported on recent international ME/CFS developments, including on research papers from Stanford University and Columbia University, the U.S. National Institute of Health’s October 2015 announcements, and ME researchers’ and patients’ push to challenge the conclusions of the 2011 Lancet paper on the PACE study. We informed the Ministry of JMEA’s outreach efforts with The Japan Society of Neurology, such as our hosting of an ME information booth at the Society’s 2015 annual conference. In light of NIH’s announcement that ME research will be under the direction of the National Institute of Neurological Disorders and Stroke (NINDS), we requested that the health agency also advance ME research as a neurological disease in Japan.

Meeting the New Chief of the Intractable Diseases Control Division

On November 9, 2015, we introduced ourselves to Norikazu Matsubara, the new section chief of the Ministry of Health, Labour and Welfare’s Intractable Diseases Control Division. We reported on our previous discussions, discussed our most recent request letter to the Health Minister, and conveyed our wishes to continue our discussions with the Division under the new section chief.

Ministry Finalizes 2014 ME/CFS Patient Survey Report

The Ministry of Health, Labour and Welfare completed its review of the 2014 “Patient Survey Concerning the Activities of Daily Living Difficulty Levels of Chronic Fatigue Syndrome Patients” report. On September 30, 2015, the Ministry distributed the final report and a summary version of the report to regional Bureaus of Health and Welfare across Japan.

We encourage patients applying for Physical Disability Certificates, assistive devices, and home nursing care to direct your local government agencies to the Ministry of Health report. We hope the distribution of the report to the regional bureaus will help make the difficult process of obtaining disability benefits smoother.

The survey objective was “to use the survey to examine and analyse the actual state of patients’ daily living, medical, and welfare situations and to prepare resources that facilitate improvements to patients’ medical welfare.” The Performance Status (PS value) Scale was used to classify patients into three severity groups; (PS value 0-5 (mild disease), 6-7 (moderate disease), 8-9 (severe disease). These classifications were used to assess the level of impairment in patients’ activities of daily living.

Among patients in the survey, mild patients comprised 31.5%, moderate patients comprised 35.1%, and severe patients comprised 30.2% (n= 248 persons). Even though patients are only able to visit doctors on good days (with doctors unable to examine patients when their health is in bad condition), there was little difference between the patients’ self-reported average PS value of 6.0 and treating physicians’ average PS value of 5.6 (according to data from treating physicians that was collected for the survey). The International Association for CFS/ME has estimated that 25% of patients are severely ill patients. Through the use of oral questioning via phone calls and home visits to moderate and severe patients, the survey was able to encompass patients who are usually unable to visit hospitals.

The report observed: “The need for assistance in activities of daily living was indicated by findings that even among mild patients, 45% needed bed rest after performing housework, with more severe impairment among moderate and severe patients. As indicated in item 23 of the survey results, the survey revealed that moderate to severe patients are dependent on family assistance to conduct activities of daily living and that, along with severe patients, patients who live alone with no family support face a serious degree of difficulty with daily living. There is a need to swiftly establish assistance measures for patients of this disease.”

In evaluating the survey, the report states that “[i]t is difficult for medical facilities to evaluate severely ill patients of this disease due to their inability to travel to doctors, and surveys which encompass such severe patients have rarely been conducted globally. Due to the very limited time period in which the current survey was conducted, it is difficult to conclude that the period was sufficient to adequately publicize the survey. We can also infer that the survey was unable to fully capture the situation of ME/CFS patients due to logistics such as the need to gather data via phone calls and home visits, as well as having family members help elicit survey responses from patients unable to respond on their own.”

The House of Representatives Adopts the Association’s Formal Petition

In the 2014 National Diet session, Japan ME Association’s petition regarding public assistance for ME/CFS patients was adopted by the House of Councillors. This year, we re-submitted the petition for adoption by the House of Representatives. On September 25, 2015, the House of Representatives’ Committee on Health, Labour, and Welfare unanimously approved the petition and announced its adoption at the House of Representatives’ plenary session. The Association’s petition was one of only two adopted among the 62 petitions submitted to the Committee in 2015.

71 Diet members across party lines agreed to introduce the petition, which we submitted with nearly 35,000 signatures, to the Diet. Signatories were not limited to ME patients and their family members, but individuals who learned about the disease for the first time and expressed their wishes for even incremental improvements to the current situation facing ME patients. The adopted petition will be delivered to the Cabinet. Thereafter, the Cabinet will inform the House of Representatives about progress made on the petition items approximately twice a year.

The Association would like to thank every individual who signed and helped us gather signatures for the petition. We would also like to thank all ME patients who participated in the 2014 Ministry of Health, Labour and Welfare’s ME/CFS patient survey. That survey revealed that 30.2% of patients in Japan are severe patients who are bedridden or nearly bedridden. The serious situation brought to light by the survey results and the widespread media coverage of its findings allowed us to persuade the government about the urgent need for welfare services for disabled patients.

We are encouraged by the adoption of our petition by the Diet. We hope that it will contribute to increased awareness about the disease and that the ME patients may be better understood by others.

We strongly desire that ME/CFS will be a covered disease under the Act on General Support for Persons with Disabilities. We will be steadfast in our efforts towards this goal until it is achieved.

List of the 71 Diet members who supported the petition (listed by party as of the date of petition submission):

Democratic Party of Japan: Tomoko Abe, Satoshi Arai, Kenta Izumi, Kensuke Onishi, Mitsunori Okamoto, Yasuko Komiyama, Kaname Tajima, Keisuke Tsumura, Katsuhito Nakajima, Akira Nagatsuma, Yasuhiro Nakane, Chinami Nishimura, Akio Fukuda, Kazunori Yamai

Komeito: Shinichi Isa, Hisashi Inatsu, Keiichi Koshimizu, Shigeki Sato, Hideo Tsunoda, Michiyo Takagi, Shigeyuki Tomita, Noriko Furuya

Ishin: Yasushi Adachi, Nobuhiko Isaka, Yosei Ide, Yasuo Urano, Mito Kakisawa, Akihito Hatsushika, Kazuhiro Shigetoku, Toshihide Muraoka

Japan Communist Party: Seiken Akamine, Chizuko Takahashi, Terufumi Horiuchi

Social Democratic Party: Kantoku Teruya

The People’s Life Party: Denny Tamaki

Unaffiliated: Toshinobu Nakasato

Negotiations with the Ministry of Health

On December 9, we met with two assistant section chiefs of the Ministry of Health, Labour and Welfare’s Intractable Diseases Division (the Specific Diseases Division was re-named effective October 1, 2015), where we submitted our most recent request letter to Minister Yasuhisa Shiozaki.

We reported on recent international ME/CFS developments, including on research papers from Stanford University and Columbia University, the U.S. National Institute of Health’s October 2015 announcements, and the effort by ME researchers and patients worldwide seeking to challenge the 2011 Lancet paper on the PACE trial. We informed the Ministry of the Association’s outreach efforts with The Japan Society of Neurology, such as our hosting of an ME information booth at the Society’s 2015 annual conference. In light of NIH’s announcement that ME research would now be led by the National Institute of Neurological Disorders and Stroke (NINDS), we requested the Ministry to also research ME/CFS as a neurological disease here in Japan.

Delivery of Petition to the Diet

On June 9th, JMEA delivered our petition for public assistance for ME patients with nearly 35,000 signatures to the 71 Diet members from both houses of the Japanese Diet who agreed to introduce the petition during this year’s extended Diet term. Deliberations on the petition are planned for end of the term. Some Diet members were in their offices when we arrived to deliver the signatures, and we were able to hand the petition to those members directly.

We gathered the signatures thanks to the combined efforts of many individuals since July 2014. The signatures were collected not only by ME patients and their families, but by many people who learned about ME for the first time and who wished to help bring about improvement in ME patients’ lives. We are deeply grateful to each individual who contributed to the petition.

The 2014 Ministry of Health ME/CFS patient survey exposed the serious situation of ME patients in Japan. Having come close last year with the petition being adopted by the House of Councillors’ in 2014, we will strength our efforts to realize the adoption of the petition by the House of Representatives in 2015.

Meeting with Minister of Health Yasuhisa Shiozaki

Japan ME Association achieved a direct meeting with Minister of Health, Labour and Welfare Yasuhisa Shiozaki at the Minister’s offices. 12 JMEA members including JMEA President Mieko Shinohara attended, together with the secretary to House of Representatives member Seiko Noda. Five officials from the Ministry’s Specific Diseases Control Division and Planning Division also attended.

We presented Minister Shiozaki with our most recent request letter. We expressed our appreciation for the Ministry’s allocation of funds in the 2014 budget for the ME/CFS patient survey. In light of that survey’s findings-which revealed that approximately 30% of patients are bedridden or nearly bedridden and that 65% patients are unable to work-we requested the Ministry’s support for the adoption our petition for public assistance of ME patients, which will be introduced before the Diet near the end of the 2015 term.

We also requested that research be funded on Waon therapy for ME/CFS. Severe ME patients who have benefited from the treatment informed the Minister that the availability of this treatment offer relief from symptoms to patients who currently have no effective medical treatment available to them.

Minister Shiozaki stated that research concerning the diagnostic criteria to be adopted in Japan is proceeding and that the work will be completed in a reliable manner. He explained that completing the diagnostic criteria was critical as a step towards the possible inclusion of ME/CFS among diseases covered by the Act on General Support for Persons with Disabilities.

The Minister stated that research on treatments must be preceded by considerations on whether treatment benefits can be scientifically proven. The Ministry must identify the most promising treatments, while keeping in mind that treatment in the earliest stages of the disease are likely to be more effective. He separately expressed his understanding of our desire for Ministry funding for research on Waon therapy.

Minister Shiozaki offered words of encouragement and shook hands with each of the ME patients and family members at the end of the meeting. Afterward, we held a press conference at the Ministry’s press club before reporters from various news agencies including NHK and Kyodo news. Coverage of the meeting aired on the evening’s 6pm Tokyo local news and 11:30pm “News Web” programs.

Presentation of 2014 Patient Survey Results at the Diet

Japan ME Association and the St. Marianna University School of Medicine held a joint presentation and press conference on the results of the Ministry of Health, Labour and Welfare’s 2014 “Patient Survey Concerning Activities of Daily Living Difficulty Levels of Chronic Fatigue Syndrome Patients” at the House of Representatives Hall on April 22nd, 2015. Lead survey investigator Dr. Kazuo Yudo of St. Marianna University School of Medicine presented the survey results, with JMEA board member Dr. Isu Shin moderating the discussion.

The survey revealed that 30.2% of ME patients in Japan are severely ill patients who are either “bedridden with need for constant assistance” or “bedridden more than half of the day with need for frequent assistance.” This finding of the percentage of severely ill ME patients in Japan was consistent with the 25% percentage of severely ill ME patients cited by the International Association for CFS/ME (IACFS/ME).

So-called moderate ME patients comprised a further 35.1% of patients. These patients are mostly housebound, and are “able to conduct self-care but are unable to participate in regular social life or perform light labor,” or “are able to perform light labor on good days but require rest at home for more than 50% of the week.” Accordingly, the survey revealed for the first time in Japan that more than 65% of ME patients in Japan face a serious degree of impairment in conducting activities of daily living.

JMEA President Mieko Shinohara emphasized that the aspect of ME that patients cited as being the most difficult was physical suffering from disease symptoms. She appealed to the Diet members in attendance to adopt the Association’s petition in this year’s Diet session, following its adoption last year by the House of Councillors, but not by the House of Representatives.

Among the many notable comments raised in the ensuing discussion included: “There seem to be more patients who report not being able to work compared to other diseases,” “It is extremely difficult for patients to obtain Physical Disability Certificates,” “Any observations concerning the large number of young people and women among patients?” and “Does the uneven regional distribution of study patients reflect the lack of specialist physicians?” Questions from the media included: “How do the study results compare to studies from overseas?,” “Are there specific infections that trigger the disease?”

The survey team responded that the survey included patients who were unable to leave their homes for regular doctor visits; that there is no government or scientific organization in Japan that recognizes physicians as ME specialists; and that there is a need to re-examine the diagnostic criteria used in Japan.

More than 120 people attended the event, including 15 Diet members and 24 secretaries to Diet members across five parties. Officials from government agencies also attended, including from the Ministry of Health’s Specific Disease Control Division, the Department of Health and Welfare for Persons with Disabilities, and the Pension Bureau, as well as from the Ministry of Education’s Special Needs Education Division of the Elementary and Secondary Education Bureau.

The survey findings were covered in the 9pm NHK national news the same evening. Articles about the survey findings appeared in national newspapers such as Asahi and Mainichi news. Kyodo news, regional media outlets, and specialty publications also covered the event.

Meeting with the Department of Health and Welfare for Persons with Disabilities

2014 meeting1 On December 9, 2014, we held talks with the new section chief and three other officials from the Social Welfare Bureaus Department of Health and Welfare for Persons with Disabilities Policy Planning Division. Eight JMEA patient, caregiver, and support members joined JMEA board members at the meeting.

We submitted our request letter to the Health Minister and provided the officials with ME resources such as our informational leaflets and DVDs. Since this was our first meeting with the new section chief, we briefed him about the severity and characteristics of ME. We explained that some patients pay JPY 25,000 out-of-pocket per month to rent electric wheelchairs due to the unavailability of any public disability assistance. Since many are unable to afford electric wheelchairs, they are unable to participate in activities like this meeting. We know of one patient who incurs over JPY 100,000 for private assistance due to her access to public welfare services.

ME/CFS is excluded from covered diseases under the Act on General Support for Persons with Disabilities, even though the expansion of covered diseases to 153 diseases was approved at the
58th meeting of the Social Security Council Disabled Persons Group. We sought and received confirmation that, in order for a disease to be included in the Act, it need not be designated as a rare or intractable disease, and that the actual need for welfare services and impairment level of patients’ activities of daily living will also be given consideration in future deliberations.

We discussed possible measures for patients whose symptoms continue to worsen as they wait for the new ME/CFS diagnostic criteria which include objective markers-a requirement for inclusion of a disease in the Act-to be established. The Ministry’s ME/CFS patient survey will come out in March 2015, bringing the plight of patients’ situations to light. We requested that the Department for Health and Welfare for Persons with Disabilities coordinate with the Health Services Bureau’s Specific Diseases Control Policy Planning Division to inform administrative agencies responsible for issuing disability certification about the serious nature of the disease.