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New Clinical Case Definition for ME/CFS: Fears It Will Be Labeled “Behavioral Health”

New Clinical Case Definition for ME/CFS: Fears It Will Be Labeled “Behavioral Health”

By PENNY SWIFT

A new clinical case definition and diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) will be announced by the US Institute of Medicine (IOM) tomorrow, six weeks earlier than its due date, March 22. Fears are, because the National Institute of Health (NIH) insisted on including behavioral health specialists on the IOM ME/CFS committee, that the new labels and criteria will endorse a body of study that says the conditions are primarily psychological or psychiatric.

Those who have opposed the controversial health research plan since it was launched more than a year ago believe its early release is “a desperate attempt to put a lid on future opposition.”

Jeannette Burmeister (above), an attorney disabled by the disease for nearly a decade, said today that the IOM’s claim to be an objective, independent institution appeared to be “a PR stunt,” since the IOM had bowed to pressure from the NIH to include psychologists on their panel.

The IOM obliged without even an iota of resistance. Jeannette Burmeister

One of the behavioral health specialists, Margarita Alegría, from Harvard Medical School’s Center for Multicultural Mental Health Research, co-authored a paper in 2011 that classifies CFS as a neurasthenia spectrum disorder – which is psychiatric in nature.

In the paper, they say that “Neurasthenia is a prevalent condition deserving further research attention given its comorbidity with other psychiatric disorders and its association with functional impairment.” But there is a lot more.

Likewise, further research is needed to examine the concordance of neuras- thenia spectrum disorders (e.g., ICD-10 neurasthenia, CFS, CCMD-2 and CCMD-3 neurasthenia) across non-clinical, population-based samples across cultural contexts. Prevalence of neurasthenia, comorbidity, and association with impairment among a nationally representative sample of US adults Kristine M. Molina Chih-Nan Chen Margarita Alegría Huijun Li

The Gulf War Illness Study

Burmeister drew a parallel with speakers who had previously addressed the IOM about Gulf War Illness, a disease that the IOM had previously renamed chronic multisymptom illness (CMI), and who expressed the view “that the illness may be psychiatric” even though there is strong evidence that science discredited this a long time ago. In this instance, the US Department of Veterans Affairs (VA) had asked the IOM to develop a case definition for CMI. But after spending $850,000 on the task, in March last year the IOM committee announced it was “unable to develop a new consensus definition of CMI given the lack of uniform symptoms, the variety of symptoms, and the long onset and duration” of the perplexing disease. For this reason, two definitions – both existing – should continue to be used. One was a broad definition developed by the Centers for Disease Control and Prevention, and the other a more restrictive definition derived from a study of Kansas Gulf War veterans. However, the committee did decide that the disease name should be changed back to Gulf War Illness.

Kenneth Shine, chairman of the IOM Gulf War Illness committee had previously stated he “could not recall when the IOM was last charged with defining a disease.”

Even though the IOM had not been able to fulfill its mandate that time, it was tasked, yet again, with defining another highly controversial and misunderstood disease, currently controversially labeled ME/CFS, which many believe should be diagnosed separately because ME and CFS are two completely different disease entities.

As Burmeister challenged in March last year: “A literature review by a majority of non-experts is as flawed a process as one can imagine for the definition of an overwhelmingly complex disease such as ME/CFS,” she said. “It cannot be done competently.”

“Expecting a different result from the IOM (than the one the institute delivered for Gulf War Illness) in the case of ME/CFS is the stuff Harry Potter books are made of (no offense to J K Rowling). Jeannette Burmeister

The world will know tomorrow. But in the meantime Burmeister has also questioned the money spent on the ME/CFS study, which was commissioned by the US Department of Health and Human Services (HHS) for a whopping $1-miilion in 2013.

What the Advocates Are Calling For

While the American public is forced to fund controversial IOM studies, the advocates, health professionals (including researchers and clinicians) and patients, simply want to adopt a set of criteria that is already in use in internationally. Initiated in  Canada, and known as the Canadian Consensus Criteria (CCC), these contain both a research and clinical case definition for ME and CFS. This was published in a peer-reviewed journal in 2003, and incorporates what was at the time, the most up-to-date scientific knowledge available worldwide.

Furthermore, the CCC was endorsed in the Primer for Clinical Practitioners that is published by the International Association of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFSME). This was the major professional international organization that was concerned with both research and the care of ME/CFS patients. But even this is outdated as the 2011 ME International Consensus Criteria shows. Now there is also an ME IC Primer based on the ME ICC which has even more credence.  

From the moment the IOM committee started its ME/CFS study, experts and patients closed ranks in a determined attempt to stop the research plan. More than 6,000 people signed an Avaaz petition to cancel the HHS/IOM contract and a group of experts sent a strongly worded letter to the US secretary of the HHS, Kathleen Sebelius, urging her to adopt the CCC for ME/CFS.

A main complaint was that sufferers have been left with no real biomedical research or effective treatments for decades, and by trying to redefine the illness, they just were prolonging time.

The letter, signed by 38 highly qualified US professionals (many of whom are doctors and specialists) and 12 equally qualified international professionals, urged the HHS to use the CCC as the only case definition and to abandon its mission to get bodies like the IOM “that lack the needed expertise to develop ‘clinical diagnostic criteria’ for ME/CFS” to basically reinvent the wheel.

Not only was the HHS wasting taxpayers money, but it was threatening to “move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

It was threatening to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”Experts’ open letter to the US secretary of HHS, September 2013

As the expert letter stated: “The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Jeannette Burmeister Wages War and Wins

Meanwhile Jeannette Burmeister declared she would wage war on legal territory that she knows so well. At the IOM’s first open committee meeting in late January last year, she told all those present that the HHS had broken federal law in terms of the Freedom of Information Act (FOIA) and was filing a lawsuit against them and the NIH in a US district court. She also stated publicly that the HHS has issued misleading statements that related to the terms and nature of the controversial contract.

In September she announced that the US District Court for the Northern District of California had ruled that both government departments had violated the FOI  by refusing to supply her with certain documents. The Court denied the government request to dismiss her lawsuit and ruled that they must produce all the required documents within 60 days. The were also ordered to pay legal costs for the attorney who acted on her behalf.

Attorneys’ fees alone amounted to more than $139,000 of wasted taxpayers’ money.

Let’s hope that the Court’s ruling will be a wake-up call for the government and a reminder that it is not above the law. Jeanette Burmeister

About Penny Swift

Penny Swift is an experienced journalist who has worked on daily and Sunday newspapers in several parts of the world. Her specialties include news, investigative, consumer, health and medical spheres.

15 comments

  1. Myalgic encephalomyelitis has been classified as a physical, neurological illness by the World Health Organisation since 1969.

    It has never been classified as a psychiatric disorder.

    • Unfortunately it is not that simple.
      The WHO International Classification of Diseases (ICD) is currently under review/revision and the new classification ICD-11 is due for release in 2017. The current ICD-10 was endorsed in 1990 and has been used since 1994. ME/CFS are included under G90-G99 Other disorders of the nervous system and more specifically under G93 Other disorders of the brain The disorder (or disorders, since they are widely considered to be different) is currently listed as “benign myalgic encephalomyelitis” even though the word “benign” is no longer used elsewhere.
      The term Bodily distress disorder is included in the current ICD-11 Beta Draft, and it may be mild, moderate, severe, other or unspecified; and it seems that this is where ME/CFS – or whatever it is going to be called – will fall. The issue is what WHO includes in the definition of “bodily distress disorder”. There are at least two working groups, and one is known to be using the Fink model that lumps misunderstood illnesses (10 of them) including ME/CFS, fibromyalgia, and irritable bowel syndrome, as “bodily distress syndrome”. Typical symptoms include headache; back, muscle and joint pain; stomach problems; shortage of breath; and fatigue, and all are categorized as “functional” syndromes that have physical symptoms that cannot be “explained by well-recognized medical illness.”
      For those who don’t know, Per Fink is a Danish medic who heads The Research Clinic for Functional Disorders and Psychosomatics in Aarhus. The clinic treats patients (including those diagnosed with ME) with cognitive behavioral therapy (CBT), graded exercise therapy (GET), and anti-depressant drugs.
      Not surprisingly, this is causing some concern in the ME/CFS community. The other concern is what WHO is including under somatoform disorders. When you consider high profile cases like Justina Pelletier in the USA (initially diagnosed with mitochondrial disease and then “somatoform disorder”) and Karina Hansen (initially diagnosed with ME and then pervasive arousal withdrawal syndrome (PAWS) – which is a very rare psychiatric disorder found in children) it becomes clear that there are international issues. Happily Justina has been returned to her family, and is now being treated for Mito; as far as I know Karina is still under the power of Fink.

      • Meghan-Morgan Shannon

        ME and CFS are NOT In current ICD-9, nor in WHO ICD &. USA’ICD-cm 10 codes together.

        ME IS G93.3.
        CFS 780.73
        ICD-9

        ME G93.3
        CFS R56 (malaise ..)
        ICD-10

  2. My wife and I share the M.E. illness and are being treated by Dr Vera at NOVA Southeastern University in Miami. She has ordered extensive tests on us that has shown we both carry active viruses such as Coxsackie, Herpes 6, and Human Parvo. We also have abnormally low Natural Killer Cell (NKC) activity given our high viral load. These tests clearly show that this disease is not “in our heads” nor is it a behavioral problem. I believe that the US government may even have created the illness and vector released it on US citizens in order to create and study it as a biological weapon. It kind of got out of hand and now they’d like to cover it all up.

  3. Thank you, Ms. Swift and the Argus Report.

    “Human progress is neither automatic nor inevitable… Every step toward the goal of justice requires sacrifice, suffering, and struggle; the tireless exertions and passionate concern of dedicated individuals.”

  4. What a waste yet again of time money resources??? Question is why?? Cover up

  5. Briefing paper on ICD-11 and PVFS, ME and CFS: Part 2

    http://wp.me/pKrrB-41q

    Extract:

    July 24, 2014: Geoffrey Reed PhD (Senior Project Manager for revision of Mental and behavioural disorders) replied to Suzy Chapman, by email:

    Dr Reed stated inter alia that the placement of ME and related conditions within the broader classification is still unresolved.

    […]

    That there has been no proposal and no intention to include ME or other conditions such as fibromyalgia or chronic fatigue syndrome in the classification of mental disorders.

    That the easiest way to make this absolutely clear will be through the use of exclusion terms. However, he would be unable to ask that exclusion terms are added to relevant Mental and behavioural disorders categories (e.g. Bodily Distress Disorder) until the conditions that are being excluded exist in the classification. That at such time, he would be happy to do that.

    Also see:

    Abstract: WPA Congress 2014: ICD-11 Symposia: Proposals and evidence for the ICD-11 classification of bodily distress disorders

    http://wp.me/pKrrB-43v

    This is the most recent proposed text for the Definition of WHO’s Bodily distress disorder:

    “Bodily distress disorder is characterized by the presence of bodily symptoms that are distressing to the individual and excessive attention directed toward the symptoms, which may be manifest by repeated contact with health care providers. If a medical condition is causing or contributing to the symptoms, the degree of attention is clearly excessive in relation to its nature and progression. Excessive attention is not alleviated by appropriate clinical examination and investigations and appropriate reassurance. Bodily symptoms and associated distress are persistent, being present on most days for at least several months, and are associated with significant impairment in personal, family, social, educational, occupational or other important areas of functioning. Typically, bodily distress disorder involves multiple bodily symptoms that may vary over time. Occasionally there is a single symptom—usually pain or fatigue—that is associated with the other features of the disorder.

    Synonyms

    somatoform disorders
    Somatization disorder
    Somatic symptom disorder”

    ———-

    Personal comment from WHO’s Dr Reed (source, Beta draft):

    “I agree that there is a potential for confusion [between BDD and] the Fink et al. construct, which is conceptually different. So, this is not ideal.

    “At the same time, there are reasons that the Working Group in this area was not happy with the term ‘Somatic symptom disorder’ and did not adopt it from DSM-5 proposals. Problems with this term include the fact that in the context of ICD it could describe a large majority of health conditions whose symptoms are, by definition, somatic. This was not an issue for DSM-5, as DSM-5 is only a classification of mental disorders.

    “However, it should be possible to arrive at some satisfactory terminology and I will discuss further with the Working Group.”
    Geoffrey Reed 2015-Jan-11 – 09:37 UTC

    • And now the IOM has decided to recommend ME/CFS is called “Systemic Exertion Intolerance Disease” (SEID) … and they have recommended that WHO immediately assign a new code in the current WHO International Classification of Diseases, tenth edition (ICD-10). That could be interesting?

      • What the final version of the report says is:

        http://books.nap.edu/openbook.php?record_id=19012&page=222

        Recommendation 1: Physicians should diagnose myalgic encephalomyelitis/chronic fatigue syndrome if diagnostic criteria are met following an appropriate history, physical examination, and medical work-up. A new code should be assigned to this disorder in the International Classification of Diseases, Tenth Revision (ICD-10), that is not linked to “chronic fatigue” or “neurasthenia.”

        The U.S. will not be implementing the WHO’s ICD-10 in October 2015.

        The U.S. will be implementing ICD-10-CM, a modified version of ICD-10, that has been developed specifically for U.S. use. ICD-10-CM is often referred to in the U.S. as “ICD-10” even though it is not the same version.

        The WHO did not adapt and will not be responsible for annual updates and revisions to ICD-10-CM because it is the responsibility of the U.S. NCHS/CMS. NCHS/CMS have been licensed by WHO, Geneva, to adapt ICD-10 for use by U.S. federal agencies.

        (See also my comment, below, about which agency is responsible for the development and annual update and revision of the version of ICD-10 that the U.S. will be implementing on October 1, 2015.)

  6. “excessive attention directed toward the symptoms, which may be manifest by repeated contact with health care providers. ” So they are trying to say that a condition which has been shown to have a genetic base is psychosomatic, yeah thats why get put me in hospital and nothing else has done any good either.

  7. Update to Letter to key Revision personnel re Continued absence of the ICD-10 G93.3 terms from the ICD-11 Beta drafting platform, June 22, 2015

    http://wp.me/pKrrB-46A

    (…)

    “Dr [Robert] Jakob (WHO ICD classifications, ICD Revision Steering Group) says he can be “crystal clear” that there is no proposal to classify the ICD-10 G93.3 legacy terms under the Mental and behavioural disorders chapter.”

  8. Penny Swift writes:

    “And now the IOM has decided to recommend ME/CFS is called “Systemic Exertion Intolerance Disease” (SEID) … and they have recommended that WHO immediately assign a new code in the current WHO International Classification of Diseases, tenth edition (ICD-10). That could be interesting?”

    The IOM Panel’s Report was a U.S. federal agency commissioned initiative.

    The U.S. uses what is known as a “clinical modification” of ICD. The U.S. is currently using ICD-9-CM (which was developed specifically for U.S. use from the long since retired WHO’s ICD-9) but will implement ICD-10-CM on October 1, 2015, which has been modified from the WHO’s ICD-10 for specific usage by U.S. agencies.

    The WHO, Geneva, is not responsible for the adaptation, development, implementation or the ongoing revision and annual updating of the U.S.’s forthcoming ICD-10-CM.

    ICD-10-CM is the responsibility of the U.S. NCHS/CMS. Where the IOM report refers to the potential addition of the SEID term to ICD-10, it is referring not to the WHO’s ICD-10, but to the U.S.’s ICD-10-CM.

    The recommendations in the report have not yet been responded to or adopted.

    If the agencies that commissioned the IOM report decide to adopt some or all of its recommendations, including the suggested name change, and they wish the term to be added to ICD-10-CM, then they will need to submit proposals to NCHS via the ICD-10-CM Coordination and Maintenance Committee for consideration of the addition of SEID to the ICD-10-CM code set.

    This is a public process which holds meetings in public, twice yearly. Submission of proposals is followed by a public comment period. Final decisions are made by the Director of NCHS.

    The ICD-10-CM code set is currently on partial code freeze until October 1, 2016. During a partial code freeze only limited classes of additions can be made. None were made for the releases for 2015 and 2016.

    So before SEID could be added to ICD-10-CM, the term would first need the approval of the stakeholder federal agencies. Then it would need submitting as a proposal to NCHS, at one of the March or September meetings. Then, if it were approved, and not all submissions are approved, or not on first submission, it could not be added until after October 1, 2016.

    As far as changes to the WHO’s ICD-10 goes. The responsibility for the annual or three yearly update cycle is the responsibility of the WHO-FIC Update and Revision Committee – made up of reps from WHO Collaborating Centers from across the world. Major changes to the code set come under the three year update cycle.

    I hope this clarifies.

  9. The wording of the IOM panel’s Recommendation in the final version of their report reads:

    ‘Recommendation 1: Physicians should diagnose myalgic encephalomyelitis/chronic fatigue syndrome if diagnostic criteria are met following an appropriate history, physical examination, and medical work-up. A new code should be assigned to this disorder in the International Classification of Diseases, Tenth Revision (ICD-10), that is not linked to “chronic fatigue” or “neurasthenia.”’

    Note that in the WHO’s ICD-10, there is no code for “chronic fatigue.” In the Tabular List for the WHO’s ICD-10, there is “Fatigue syndrome” which is the Inclusion term to F48.0 Neurasthenia, and “Malaise and fatigue” at R53, in the Symptoms and signs chapter.

    It is the U.S.’s ICD-10-CM that has Tabular List entries for “(R53.82) Chronic fatigue, unspecified” and “Chronic fatigue syndrome NOS.”

    Going back to ICD-11, as you are interested and concerned about ICD Revision’s proposals for a replacement disorder category which is proposed to subsume all the ICD-10 Somatoform disorder categories between F45.0 – F45.9, and also F48.0 Neurasthenia, which is also proposed to be retired for ICD-11 and for the abridged Primary Care version, ICD-11-PHC, you may be interested in this post on my site:

    In May, I submitted a referenced commentary via the Beta platform Comment facility, for the consideration of the ICD-11 Topic Advisory Group for Mental Health and its sub-working group, the Working Group on Somatic Distress and Dissociative Disorders (S3DWG).

    As one needs to be registered with the Beta draft in order to read/make comments and submit proposals, I have published a copy of my commentary on my site:

    Comment submitted to ICD-11 Topic Advisory Group for Mental Health re: Bodily distress disorder, June 20, 2015:

    http://wp.me/pKrrB-465

    This post also cites a number of papers that may be of interest to you.

    A summary of the main points to emerge from my discussions with WHO’s Dr Robert Jakob, on June 19, can also be found in this post: http://wp.me/pKrrB-46A

  10. Dr Lucinda Bateman, one of the panel members for the IOM report, has responded to a number of questions about the content of the report in a blog post on Phoenix Rising:

    http://phoenixrising.me/archives/26692

    “Dr. Bateman:

    “…The short answer is that to my knowledge the IOM committee was not asked to address coding, nor did it, other than to recognize that at some point coding would need to be addressed. It is my impression that our committee, as a U.S.-based non-profit contracted by DHHS, was generally referring to ICD-10-CM.”

    Dr Bateman has states elsewhere that the panel had not been not tasked with making recommendations about coding and ICD.

  11. February 12, 2014: WHO, Geneva, public statement: “Fibromyalgia and ME/CFS are not included as Mental & Behavioural Disorders in ICD-10, there is no proposal to do so for ICD-11.”

    February, 14, 2014: Gregory Hartl, Head of PR/Social Media, WHO, Geneva: “there is and never was any intention to [reclassify Fibromyalgia and ME/CFS as a Mental and Behavioural Disorder].”

    July 24, 2014: ICD Revision’s Dr Geoffrey Reed, Project Lead, Mental or behavioural disorders: “There has been no proposal and no intention to include ME or other conditions such as fibromyalgia or chronic fatigue syndrome in the classification of mental disorders.”

    June 19, 2015: WHO, Geneva, Dr Robert Jakob, via teleconference: “I can be crystal clear that there is no proposal to classify the terms under the Mental or behavioural disorders chapter.”

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