JMEA Meets Parliamentary Vice-Minister Fusae Ota

Ota meeting1JMEA held an in-person talks with Parliamentary Vice-Minister of Health, Labour and Welfare Fusae Ota at the Ministry offices on January 29, 2015. JMEA was represented by eight members, including three ME patients and one family member, each who braved the cold weather to attend.

Since this was JMEA’s first meeting with Vice-Minister Ota, we briefed Ms. Ota on the disease’s main characteristics as well as the serious situation of ME patients in Japan revealed by the Ministry’s 2014 patient survey.

We discussed last fall’s decision by NIH to move the leadership for ME/CFS research in the United States to the National Institute of Neurological Disorders and Stroke (NINDS), and the January signing of a Memorandum of Cooperation between NIH and the Japan Agency for Medical Research and Development (AMED), in which the agencies agreed to strengthen cooperative research efforts including in areas such as rare diseases and infectious disease treatments. JMEA requested that Japan take similar steps to advance research on ME as a neurological disease.

We told the Vice-Minister of the rising interest among Japanese neurologists to pursue serious research on the treatment of ME. As medical research on effective treatments is the government action that patients seek most, we requested that the Ministry support research on ME/CFS treatments. (We also mentioned the widespread effort by scientists and patients to challenge the PACE study and its conclusions.)

Our patient members also appealed to the Vice-Minister with specific comments about their personal experiences and desire for effective treatments as soon as possible:

“There are so few doctors who can even diagnose the disease that it took me years to receive a diagnosis. I would like research on treatment to proceed as soon as possible.”

“I have been mostly surviving on IV infusions five times a week for the last six to seven years. I would like treatment research to proceed while I am still living.”

“Most ME patients are forced to quit school and work. There are many patients who aren’t able to come to meetings like this are who are pressed by extreme financial hardship because they are unable to obtain any public disability assistance.”

The Vice-Minister shared that she had traveled to the U.S. to attend the signing ceremony for the NIH-AMED Memorandum of Cooperation. She also explained to us that while there have been shifts towards funding disability and welfare in the U.S., Japan remains a vertically-oriented, compartmentalized bureaucracy in which the moving around of government resources is not a simple matter.

At the same time, Ms. Ota understood the need for research on treatments, and commented that more “decisive politics” is being sought within government. She believed that learning the situation of ME patients from meetings like ours (from patients themselves) was the most effective, and that she would work diligently to understand the situation. She would convey the details of our meeting to the Health Minister.

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.

Ministry of Health Publishes Patient Survey Report on Website

We reported earlier that the Ministry of Health distributed its final report (as well as a summary version) on its 2014 “Patient Survey Concerning the Activities of Daily Living Difficulty Levels of Chronic Fatigue Syndrome Patients” to regional Bureaus of Health and Welfare on September 30, 2015.

The reports had been sent as a liaison office communication from the Ministry’s Health Service Bureau Specific Diseases Control Division and the Social Welfare Bureau Disability Welfare Policy Planning Division to the regional bureaus. The communication from the Ministry stated: “[t]his report is being distributed to assist in administration matters such as responding to requests for advice from CFS patients and patients with similar symptoms and in making disability certification determinations. Please provide the information to the physicians designated to issue disability certifications within your jurisdictional district.”

The report and summary report have now been published on the “Intractable Disease, Rheumatoid Arthritis, Allergy, Kidney Disease, Chronic Pain-Related Information” page of the Ministry of Health, Labour and Welfare website under the following title: “Report on Patient Survey Concerning the Activities of Daily Living Difficulty Levels of Chronic Fatigue Syndrome Patients.”

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.”

 

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.

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.