The following petition was adopted by the both Houses of the Japanese National Diet on December 14, 2016.
Petition to Establish a Structure for Medical Care and to Advance Clinical Trial Research for Myalgic Encephalomyelitis
To the Speaker of the House of Representatives
To the President of the House of Councillors
1. Petition Summary
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex, multi-systemic chronic disease that affects the central nervous system. Functional impairment affects the entire body, and as with other severe diseases such as cancer, heart disease, and AIDS, ME/CFS causes marked declines in patients’ quality of life. Central characteristics of the disease are central nervous system-related abnormalities and autonomic dysfunction, and it is commonly known in countries in Europe and North America that disease onset normally follows a viral infection. There are internationally-recognised diagnostic criteria and an established disease concept, and the number of patients in Japan is estimated to be between 240,000 to 300,000 patients.
The 2014 national patient survey conducted by the Ministry of Health, Labour and Welfare revealed that 30.2% of ME/CFS patients were severely ill cases where patients were bedridden or close to bedridden. The International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME) has estimated that 25% of ME/CFS patients are severely ill patients, and the survey indicated that the same situation exists in Japan. Notwithstanding the re the survey, ME/CFS was not designated as an Intractable Disease nor as a disease covered by the Act for Comprehensive Welfare of Persons with Disabilities. Further, because there are so few specialist doctors, there are many persons throughout the country who are unable to even receive a diagnosis.
On October 29, 2015, the United States National Institutes of Health (NIH) announced a multicenter research study led by the National Institute for Neurological Disorders and Stroke (NINDS) to advance ME/CFS research. It is groundbreaking that NIH’s neurological section will lead biomedical research for this disease, which is classified as a neurological disorder (ICD-10 93.3) by the World Health Organization (WHO) International Classification of Diseases. The main objective of the study is to elucidate the clinical and biological characteristics of post-infectious ME/CFS, where ME/CFS starts after an infection, in order to increase our understanding of the cause and symptom progression in the disease. The study will include only patients whose disease began after having symptoms of an acute infectious disease and reflects the importance of approaching ME/CFS research from an immunological perspective.
Japan should similarly advance research on ME/CFS as a neurological disease in light of the research collaboration memorandum between Japan’s Agency for Medical Research and Development (AMED) and the United States National Institutes of Health (NIH). The two agencies announced that they would increase research collaboration, including for the treatment of intractable diseases and infectious diseases, as well as the sharing of research data. Amidst this development, Japan’s National Center Neurology and Psychiatry (NCNP) has recently initiated new biomedical research on the disease.
While the cause of the disease is not yet known and there are no established treatments, what patients wish for most is even incremental relief from disease symptoms. Further, a significant number of patients become sick at a young age and resulting economic losses are immeasurable. While clinical trial studies for drugs such as Rituximab and Ampligen have been conducted overseas over many years, Japan has never conducted such studies.
Seeking to relieve the daily suffering of patients and for research advancements which will lead to real improvements in their quality of life, we request the government to consider to the fullest extent possible the urgent situation facing patients, and petition for the following items.
II. Petition Items
1. Establishing a Structure for the Medical Care of ME/CFS patients
With assistance from neurologists from institutes such as the National Center for Neurology and Psychiatry, please accelerate research for diagnostic criteria that include objective disease markers for ME/CFS and for medical treatments, and establish a national structure in which neurologists and doctors who work with neurologists may provide medical care to ME/CFS patients.
2. Advancement of Clinical Trial Research for ME/CFS
Based on an understanding of international and domestic research on treatments for ME/CFS, please urgently advance research to develop treatments for ME/CFS, including clinical trials for drugs such as Rituximab and Ampligen.