Concerns regarding the Japanese Ministry of Health’s Informational Materials on ME

Japanese legislators rely on the Japanese Ministry of Health for accurate and up-to-date information on diseases, including for ME/CFS. For this reason, the  Association was deeply concerned to discover on February 7, 2019 the informational materials on ME/CFS that the Ministry currently distributes to members of the Japanese legislature who wish to learn about the disease.

Presented in a fact-sheet format, the information (translated below) contains inaccuracies which combine to depict ME/CFS as a mild fatigue syndrome with psychological components. The Ministry’s distribution of this misleading information to Japan’s policymakers directly affects the situation faced by ME/CFS patients in Japan, where medical professionals still do not recognize ME as a disabling physiological disease and where patients lack access to the medical care and disability assistance they need. 

The summary is misleading in what it includes and what it excludes. ME/CFS is described in a list of symptoms that any healthy person might have: chronic malaise, fatigue, headaches, and cognitive dysfunction. The list notably includes depression, which is not a symptom of ME/CFS, while it excludes PEM (post-exertional malaise), the worsening of physical and cognitive impairments following exertion, a hallmark symptom of the illness. 

The information makes no mention of the nature and severity of patients’ physical disability that was revealed by the Health Ministry’s own 2014 ME/CFS Patient Survey. That survey found that 30% of patients are severely ill patients who are bedridden or close. 

The information is also misleading in its listing of psychiatric conditions as comorbidities without providing any other context. Taken together with the mention of antidepressants and psychological therapy as existing treatments, we believe anyone relying on this summary alone to learn about ME/CFS would conclude that ME/CFS is a) a mild illness b) which has a psychiatric or psychosomatic component. It is not explained that patients may experience secondary depression as a reaction to the financial burdens and social isolation that come with the loss of their careers and active family and societal roles on top of suffering from a chronic disabling physiological disease. 

The information omits the fact that the illness has been classified as a neurological disorder by the WHO in its International Classification of Diseases since 1969.

The following is an English translation of the information:

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

(1) What is ME/CFS:

(1)   Summary

A syndrome where patients are affected by severe generalized malaise of unknown cause followed by strong fatigue along with symptoms such as mild fever, headache, muscle pain, a sense of exhaustion, cognitive dysfunction, and depression which continue over a long period. Comorbid symptoms include mood disorders, somatic symptom disorders, anxiety disorders, fibromyalgia, and irritable bowel syndrome.

Chronic fatigue syndrome is a syndrome that was reported by the United States Centers for Disease Control in 1988 (Chronic Fatigue Syndrome: CFS). In the United Kingdom it was also called myalgic encephalomyelitis (Myalgic Encephalomyelitis: ME) but in recent years it is being said that these might be the same syndrome.

(2)   Cause

The involvement of infectious disease, immune function abnormalities, autonomic nervous system abnormalities, and endocrine abnormalities have been suggested but the cause is unknown.

(3)   Diagnostic criteria / Treatment

At present no diagnostic criteria which uses objective markers has been created in any country. Vitamins, antidepressants, Chinese herbal medicine, and psychological therapy are being tried, but no effective treatment methods have been established.

 

Status of the 2017 Proposed ME/CFS Treatment Guidelines (Draft)

In late 2017, JMEA submitted its opposition to the publication of national ME/CFS treatment guidelines for Japan (Draft), which was scheduled to be published in spring 2018. The document was not published in spring 2018 but was set to be filed as a research report with the government health agency Japan Agency for Medical Research and Development (AMED). We are currently awaiting the release of this report and will provide a further update on the research report when it becomes publicly available.

The Association is deeply grateful to the international ME/CFS medical experts and advocacy organizations which kindly responded to our request to provide comments on the draft treatment guidelines document. We immediately shared your comments with the research committee which drafted the document and with the Ministry of Health.

In August 2018, we held a press conference at the Ministry of Health on the opinion letter we received from the International Association for CFS/ME (IACFS/ME) in response to our request for the association’s opinion on translated excerpts of the document. In the opinion letter, the IACFS/ME expressed concern that the document could be of potential harm to ME/CFS patients in Japan due to the recommendation of Graded Exercise Therapy (GET) as an effective treatment. The letter also shared our concern that the discussion in the document of behavioral interventions such as Cognitive Behavioral Therapy and yoga and of antidepressant drug therapy could give the mistaken impression that ME is a psychological illness which can be cured by such interventions. Questions from the press included why the opinions of the international and Japanese ME/CFS experts differed, among more specific questions about the document.

 

 

 

 

 

JMEA signs Letter to WHO Director-General Dr. Tedros Adhanom Ghebreyesus

As part of our collaborative actions with international ME advocacy organizations along with our participation in the global day for health equality for ME/CFS #MillionsMissing, Japan ME Association has co-signed an open letter to the WHO Director-General Dr. Tedros Adhanom Ghebreyesus from the International Alliance for ME requesting a meeting to highlight the serious and significant impact of ME and to “explain why we are seeking urgent national and international action to increase research on [ME] and ease the suffering of patients around the world.”

We support this letter along with ME advocacy organizations from the UK, the United States, Australia, South Africa, Spain, and other countries in our sincere hope that the Director-General will accept the International Alliance’s invitation to speak with him to address the urgent situation facing ME patients worldwide at the WHO level. The full text of the letter can be found here.

Our Opposition to Proposed National Treatment Guidelines for ME/CFS

Japan ME Association held a press conference at the Ministry of Health, Labour and Welfare’s press club on December 14, 2017 to announce our opposition to the public draft of proposed “Treatment Guidelines for ME/CFS for Japan,” issued by the Research Committee for the Development of Treatments and Treatment Guidelines for ME/CFS for public comment. The  proposed clinical treatment guidelines for ME/CFS are scheduled to be published in spring 2018 in Nihon Iji Shimpou, one of the most widely read medical journals in Japan.  JMEA received a request to submit an external review in November 2017, and we announced our opposition to the proposed guidelines at the press conference. NHK, The Asahi Shimbun, The Sankei Shimbun, Kyodo News, and several regional media outlets attended.

JMEA believes that the proposed treatment guidelines do not provide an adequate, reliable, or safe basis for clinicians in Japan to make treatment decisions for ME/CFS patients in real-life clinical settings. The research committee evaluated various treatments to create the proposed treatment guidelines solely on the basis of a literature review (using an “Evidence-Based Medicine” analysis), with each treatment given an effectiveness grade of an ‘A’ to ‘I’ grade-rating (with an A-grade being the most effective).

The result is a document that merely discusses the results of the committee’s literature review, with no A-grade treatments and with a single B-grade treatment recommendation for Graded Exercise Therapy (GET) (all other treatments mentioned in the guideline document — CBT, antidepressants and other drug treatments, Chinese herbal medicines, and yoga — were rated C-grade or lower), with no discussion or guidance on how to distinguish among the appropriateness of the various treatments for actual ME/CFS patients, each with varying symptoms and severity of illness.

Further, the proposed treatment guidelines pose a risk to worsening the symptoms and overall health of ME/CFS patients in recommending Graded Exercise Therapy (GET) as the single treatment with the highest B-grade rating. In particular, gradually increasing aerobic exercise until the patient can return to their normal lives is recommended. (The guidelines recommend GET under the guidance of an appropriate instructor. However, as the document acknowledges apart from its recommendation, primary care doctors, rehabilitation specialists, and physical therapists in Japan do not have knowledge or training about ME/CFS or its symptoms.)

We believe that there is a serious problem where GET is set be established in the national treatment guidelines for Japan as the most highly-rated treatment where GET has been under harsh scrutiny and is being re-evaluated or rejected in the rest of the world. The document acknowledges in footnotes, for example, that the United States Centers for Disease Control (CDC) recently removed GET from its ME/CFS website. Nevertheless, GET is still presented in the proposed guidelines as a highly effective ME/CFS treatment based on the result of the committee’s “evidence-based medicine” literature analysis of research studies mostly from the United States and Europe. The guidelines cite to old studies where the diagnostic criteria used to screen patients are opaque, as well as to studies published in psychology journals and to the highly criticized PACE trial in its list of references in support of its treatment recommendations.

Recent research studies have shown that increasing exercise after a certain (low) threshold leads to a worsening of symptoms, with more medical institutions finally acknowledging this reality in the West. Japan and Japanese ME/CFS patients should not remain in the dark ages on this critical development.

In addition to posing a risk of worsening symptoms – especially where there is a complete lack of knowledge among Japanese physicians, physical therapists, and exercise specialists about ME/CFS and its symptoms, including the post-exertion exacerbation of symptoms – the recommendation of GET in the treatment guidelines will inevitably (and unnecessarily) deepen prevalent and mistaken beliefs about ME/CFS that are currently held among the vast majority of Japanese medical professionals (for example, that ME/CFS is a psychological illness that can be improved by gradually increasing exercise).

JMEA opposes the proposed treatment guidelines for the simple reason that they pose a serious risk to ME/CFS patients. With only a very small handful of doctors in Japan who have experience diagnosing and treating ME/CFS, the individuals who stand to suffer most from this document are ME/CFS patients in Japan of all severities of illness, including and especially severely ill patients.

We outlined the following seven reasons for our opposition to the proposed ME/CFS treatment guidelines in our written external review submitted to the research committee:

1. With no A-grade treatment recommendation and one single B-grade recommendation, the proposed ME/CFS treatment guidelines do not provide an adequate and reliable basis for physicians to determine safe and appropriate treatments for ME/CFS patients of varying illness severity in real-life clinical settings.

2. We are seriously concerned that the mostly highly recommended treatment in the proposed treatment guidelines for Japan will be for Graded Exercise Therapy (GET), a treatment being rejected around the world, and which poses a risk of worsening, and not improving, patients’ symptoms.

3. We question whether the research committee took into account the diagnostic criteria employed in the research studies that were evaluated for the “evidence-based medicine” literature review analysis on which the development of the proposed guidelines was based.

4. We question the paper’s analysis regarding the effectiveness of antidepressants to treat ME/CFS. If the selected literature included studies where there were a mix of ME/CFS patients and patients with major depression (which can easily result from the use of old diagnostic criteria such as the Oxford criteria), there is a question about the effectiveness of antidepressants to treat ME/CFS, distinguished from its effectiveness for treating depression, including secondary depression symptoms that some ME/CFS patients experience as a result of the social, financial, and personal consequences of living with a serious disabling physical illness. Because this distinction is not explained in the document, the proposed treatment guidelines gives a misleading impression about the effectiveness of antidepressants to treat ME/CFS itself.

5. In its explanation of ME/CFS, the draft treatment guidelines omit the fact that the ME is classified as a neurological disorder in the World Health Organization’s International Classification of Diseases.

6. In its explanation of ME/CFS, the proposed treatment guidelines state that the estimated the number of ME/CFS patients in Japan is 300,000, while the most recent (2012) AMED research committee concluded that the number is 0.1% of the population (a number closer to 100,000).

7. The proposed treatment guidelines were created solely using a literature review, without considering clinical information or data.

Patients already suffer from being told that the illness is “all in their heads,” that they can be cured with a change in thinking, antidepressants, or exercise, with even close family members and friends not grasping the seriousness of the illness. Patients often do not look sick and are often viewed as being malingerers. As a patient association, we cannot permit a foreseeable situation to come about that harms patients by perpetuating and exacerbating the existing problems about how the illness is viewed, understood, and treated by medical professionals in Japan.

Questions from the press included: “Did the Ministry of Health commission the drafting of these guidelines?” “Why do you believe guidelines were drafted which would be opposed by patient groups?” “If the treatment guidelines are published, will they actually be implemented?” “What kind of treatments are patients currently receiving?” and “What position is the Japanese Neurology Society taking?”

We welcome your comments in English or Japanese on the serious issues raised by the proposed national treatment guidelines for ME/CFS. Please send them to the following email address for Japan ME Association: cfsnon@gmail.com

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.

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.