Monday, February 16, 2015

The IOM Report: The Good, The Bad, and the Absolutely Hideous

Note: I have read the entire report, and I have also looked at the references. Page numbers are listed throughout the commentary below.

Anyone who would like to reprint this post has my permission.

The IOM Report, "Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness" was released on Tuesday February 10, 2015. (You can read and/or download the report as well as watch the video of the announcement HERE. You can get the gist of the report by reading the Summary at the beginning, or Recommendations on page 209.)

Much like its previous report on Gulf War Illness, the IOM's report on ME/CFS has generated a tremendous amount of media coverage (TimeCBSNY Times BlogABC), as well as spirited discussion in the ME/CFS community. While mainstream organizations have welcomed the report's emphasis on the serious nature of the disease, there are some lingering doubts about the appropriateness of the new name, "systemic exertion intolerance disease" (SEID), as well as the viability of the new definition.

The report made four recommendations:
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 Edition (ICD-10), that is not linked to “chronic fatigue” or “neurasthenia.”
Recommendation 2: The Department of Health and Human Services should develop a toolkit appropriate for screening and diagnosing patients with myalgic encephalomyelitis/chronic fatigue syndrome in a wide array of clinical settings that commonly encounter these patients, including primary care practices, emergency departments, mental/behavioral health clinics, physical/occupational therapy units, and medical subspecialty services (e.g., rheumatology, infectious diseases, neurology).
Recommendation 3: A multidisciplinary group should reexamine the diagnostic criteria set forth in this report when firm evidence supports modification to improve the identification or care of affected individuals. Such a group should consider, in no more than 5 years, whether modification of the criteria is necessary. Funding for this update effort should be provided by nonconflicted sources, such as the Agency for Healthcare Research and Quality, through its Evidence-based Practice Centers process, and foundations.
Recommendation 4: The committee recommends that this disorder be renamed “systemic exertion intolerance disease” (SEID). SEID should replace myalgic encephalomyelitis/chronic fatigue syndrome for patients who meet the criteria set forth in this report. [Italics mine throughout]

Some Background: The IOM's Charge

The IOM is an independent nonprofit organization founded in 1970. As health arm of the National Academy of Sciences, it works outside of the federal government to provide "unbiased and authoritative advice" to decision makers and the public. Because it is not part of the federal government, its decisions to not constitute policy. No branch of HHS is obliged to follow its recommendations.

In 2013, HHS contracted the IOM to evaluate the current criteria for diagnosis of ME/CFS and recommend clinical diagnostic criteria that would "address the needs of health care providers, patients, and their caregivers."

Specifically, the committee was asked to:

• conduct a study to identify the evidence for various clinical diagnostic criteria for ME/CFS using a process with input from stakeholders, including practicing clinicians and patients;

• develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology;

• recommend whether new terminology for ME/CFS should be adopted; and

• develop an outreach strategy for disseminating the new criteria nationwide to health professionals.
The committee was also asked to distinguish among disease subgroups, develop a plan for updating the new criteria, and make recommendations for the plan’s implementation.

With the exception of the CAA (now Solve ME/CFS Initiative) the immediate reaction to the million-dollar IOM contract was negative. Fifty of the world's leading experts in ME/CFS wrote a letter to then Secretary of HHS Kathleen Sebelius endorsing the Canadian Consensus Criteria (CCC) a definition based on "scientific knowledge gained from decades of research. " The letter also warned that the contract "would 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." (You can read the letter HERE.) The letter was supported by hundreds of advocates, as well as petitions which garnered 10,000 signatures.


Analysis in a nutshell

Pros:
  • The report clearly states that ME/CFS is a complex a "serious, chronic, complex, multisystem disease that frequently and dramatically limits the activities of affected patients.
  • The report recommends abandoning the name "chronic fatigue syndrome."
  • The report recognizes that research funding has been inadequate.
Cons:
  • The report recommends a definition that is simplistic, undermining the statement that ME/CFS is a "complex, multi-system disease."
  • By limiting diagnosis to four or five non-specific symptoms, the IOM definition, like the Fukuda definition, will capture people without ME/CFS.
  • The core symptoms of the new diagnosis fit into the clinical definition for depression (fatigue, insomnia) with anxiety (symptoms made worse by stress).
  • Exertion intolerance has been, and will be, interpreted by physicians as a psychosomatic manifestation of "fear avoidance" of exercise.
  • The name "systemic exertion intolerance disease" reduces ME/CFS to a single symptom.
  • The inclusion of "systemic" in the name is meaningless. All diseases are systemic.
  • Exclusionary diagnoses are no longer ruled out, which means patients with early MS, Hashimoto's, lupus, mitochondrial disease, Ehlers-Danlos and other treatable but hard-to-detect illnesses may receive a false diagnosis of SEID.

In-depth analysis of the report

The Good

Excellent overview of the research

On the whole, the report did a very good job of discussing the research pertaining to diagnosis, subgroups, symptoms clusters, as well as documenting key problems such as lack of funding for research, and inadequate coverage in medical schools. Anyone taking the time to read the entire report would have a clear view of the types of problems faced by the ME/CFS community. (One of those problems is the constant confusion between "chronic fatigue" and CFS, a problem which the IOM perpetuated by citing studies on "chronic fatigue.") 

Abandonment of chronic fatigue syndrome

After a healthy discussion of all the reasons why CFS is a poor name for the disease, the IOM concluded that "the term 'chronic fatigue syndrome' often results in stigmatization and trivialization and should no longer be used as the name of this illness" (p 60).  The report goes on to say that "ME/CFS should not be considered merely a point on the fatigue spectrum or as being simply about fatigue. [...] Other factors, such as orthostatic intolerance, widespread pain, unrefreshing sleep, cognitive dysfunction, and immune dysregulation, along with secondary anxiety and depression, contribute to the burden imposed by fatigue in this illness."

Recognition of 2-day CPET as an objective measure of ME/CFS

The IOM report recognizes PEM as one of the defining characteristics of ME/CFS (though the report also mentions that PEM is experienced by patients with MS and major depression). Citing the Keller and Snell studies, the report supported the 2-day CPET protocol "as an objective indicator that physical exertion may decrease subsequent function in some ME/CFS patients. By contrast, a single CPET may be insufficient to document the abnormal response of ME/CFS patients to exercise" (p 84).

Recognition of cognitive impairment and brain abnormalities

The IOM reviewed the past ten years of research on neurocognitive impairment and brain abnormalitites, and did a credible job of summarizing them. While the IOM did not draw any conclusions from the brain studies it examined (including the recent Nakatomi study on brain inflammation, but omitting the Stanford study) the committee did state that "There is sufficient evidence that slowed information processing is common in patients with ME/CFS, and a growing body of evidence shows that it may play a central role in overall neurocognitive impairment associated with the disease. Such a deficit may be responsible for the disability that results in loss of employment and loss of functional capacity in social environments" (p 106).

Recognition of immune dysfunction

After a review of NK cell toxicity and immune activation studies the IOM concluded that "Sufficient evidence supports the finding of immune dysfunction in ME/CFS" (p 153).

Acknowledgment of pediatric ME/CFS

"There is sufficient evidence that orthostatic intolerance and autonomic dysfunction are common in pediatric ME/CFS; that neurocognitive abnormalities emerge when pediatric ME/CFS patients are tested under conditions of orthostatic stress or distraction; and that there is a high prevalence of profound fatigue, unrefreshing sleep, and post-exertional exacerbation of symptoms in these patients. There also is sufficient evidence that pediatric ME/CFS can follow acute infectious mononucleosis and EBV" (p 201).

Recognition that research funding has been inadequate

"Remarkably little research funding has been made available to study the etiology, pathophysiology, and effective treatment of this disease, especially given the number of people afflicted" (p 9).


The Bad: Non-Specific Definition

The IOM report sends mixed messages to medical professionals. On the one hand, it states that ME/CFS is a "serious, complex" disease. But on the other, it presents diagnostic criteria that are oversimplified, giving the impression that this is not a serious, much less potentially fatal, illness. Of the two messages, the second will have the greater weight. Regardless of the encouraging language used in the report, medical professionals are much more likely to read a short definition than a 282-page document.

The new IOM definition is a highly reduced version of the Canadian Consensus Criteria, consisting of three non-specific (i.e. common to many illnesses) required symptoms, and two non-specific optional symptoms. Because it consists of non-specific symptoms, the IOM definition will capture a number of illnesses in addition to ME/CFS, making it useless for research and too broad for diagnosis. (This is precisely the problem with the Fukuda definition.)

IOM Definition
Diagnosis of ME/CFS requires that a patient have the following three core symptoms:
  1. A substantial reduction or impairment in the ability to engage in pre-illness levels of activities that persists for more than six months and is accompanied by fatigue - which is often profound - of new or definite onset, not the result of ongoing excessive exertion and not substantially alleviated by rest 
  2. The worsening of patients’ symptoms after any type of exertion - such as physical, cognitive, or emotional stress - known as post-exertional malaise 
  3. Unrefreshing sleep
At least one of the two following manifestations is also required:
  1. Cognitive impairment 
  2. The inability to remain upright with symptoms that improve when lying down - known as orthostatic intolerance
Fatigue

The first symptom is still six months of fatigue. The IOM report states, "This 6-month requirement is supported by Nisenbaum and colleagues (1998), who showed that unexplained fatigue lasting for more than 6 months was related to symptoms included in the ME/CFS case definitions and that most other causes of similar fatigue do not last beyond 6 months." This implies that most cases of "similar fatigue" are self-resolving. In fact, the Nisenbaum study did not find that similar fatigue from other causes resolved within six months, because other causes of fatigue were not explored. The only conclusion Nisenbaum et al. reached was that six months appeared to be a "threshold" for severity of CFS symptoms. However, their data indicated that this threshold was relatively modest, with percentages varying only slightly between the 1-5 month range and the 6-month or longer range. 

Nevertheless, six months of "fatigue" is still required, which will miss all the sudden onset cases. This is problematic, because the initial "acute" phase of the disease is what is most puzzling to physicians. Patients who come to their doctors horribly ill several weeks after a "flu" are taken seriously, because the acute phase is quite dramatic. This is the phase in which test results (including ECGs and CBCs) are often abnormal, and in which physicians write prescriptions for numerous medications, none of which help and many of which harm patients. A case definition for a disease that can develop with such speed and severity should include a provision for sudden onset.

Ultimately, six months of fatigue is still the predominant symptom in this definition, and because there are so few others, physicians will retain "chronic fatigue" as the go-to symptom for diagnosis. And because chronicity is established after six months, it is likely that physicians will dismiss patients with long-term fatigue who do not have measurable signs (and who complain of non-specific symptoms) as having psychological disorders.

PEM

The second symptom, PEM, will inevitably be interpreted as "exercise intolerance" by physicians. Exercise intolerance is a term that physicians understand, as it is commonly used in association with cardiopulmonary illnesses. Physicians may also interpret PEM as "avoidance of exercise," which, when combined with fatigue, sleep disorder, and cognitive problems (the result of lack of sleep) will lead them to think that a patient presenting these symptoms needs therapy or antidepressants.

PEM is non-specific. Contrary to popular belief, PEM is not unique to ME. Patients with early MS, B12 deficiencies, Hashimoto's disease, and lupus all experience a worsening of symptoms after exertion. Regardless of the severity and permutations of PEM, physicians will not investigate the fine points. Nor will they ever consider a worsening of symptoms after emotional or cognitive stress to be anything other than psychosomatic.

Doctors are taught in medical school to look for horses, not zebras, "horses" being common ailments, and "zebras" the more exotic or rare illnesses. In 2008, Drs. Philip R. Fischer, Jonathan N. Johnson, and Chad K. Brands wrote an an excellent article titled, "Fatigue, Exercise Intolerance, and Weakness: Lessons on Herding Zebras" in which they presented case studies demonstrating why physicians need to look beyond the obvious diagnosis. Of three pediatric cases in which the patients presented with typical symptoms of CFS, one had POTS, one had pheochromocytoma (benign adrenal tumor), and one had undiagnosed dermatomyositis (an inflammatory disease). All of these patients would meet the criteria for SEID.

Unrefreshing Sleep

Waking up tired, even after what may be considered adequate sleep, is universal in ME/CFS.  It is also common in hypothyroidism, low adrenal function, fibromyalgia, narcolepsy, Lyme disease, allergies, sleep apnea and depression. Most doctors seeing a patient with the triumvirate of fatigue, unrefreshing sleep, and cognitive problems will conclude that the patient has depression, especially if standard blood tests are negative. The addition of "exertion intolerance" does not exclude depression, or distinguish ME/CFS from any number of illnesses in which an exacerbation of symptoms after exertion is a feature.

Cognitive Impairment and OI

The IOM included cognitive impairment as an optional symptom, even though "Impairments in cognitive functioning are one of the most frequently reported symptoms of ME/CFS" (p 96). Why cognitive impairment is optional is not clear, as it is one of the cardinal symptoms of ME/CFS.

Orthostatic intolerance was also included as an optional symptom, which is also puzzling. OI is usually included under autonomic dysregulation, which can also include other symptoms, such as migraine, temperature and blood pressure fluctuations, and other manifestations of autonomic dysfunction, all of which are found in patients with ME/CFS. There is also a tremendous overlap in symptoms between POTS (postural orthostatic tachycardia syndrome - the most common form of dysautonomia), and ME/CFS. (Anyone with POTS will fit the IOM definition of SEID, and vice versa,)

Although the committee did not examine etiology, they would have greatly benefited from reading Dr. Jay Goldstein's book, The Limbic Hypothesis, in which he theorizes (with substantial evidence) that injury to the limbic system causes the symptoms of ME/CFS. The hypothalamus, which controls the autonomic nervous system, is located in the limbic system. It is a tiny organ, easily damaged by high fevers, hypoxia, and neurotoxins, It would have aided the IOM to understand some of the major theories behind the symptoms that they chose to include in their definition, even if it was not part of their charge. As the experts predicted, the IOM lacked "the needed expertise to develop “clinical diagnostic criteria” for ME/CFS."

Pain

The IOM stated that "Pain is a defining characteristic of ME/CFS ... The majority of ME/CFS patients experience some type of pain" (p 141). However, it rejected pain as a core symptom because of the "less prominent role of myalgia in these patients relative to more core symptoms" (p 11). In making this statement, the IOM is overlooking their own research review. According to the studies the IOM reviewed, pain appeared with equal frequency to core symptoms.

The ultimate reason for rejecting pain was "while pain worsens ME/CFS when present, there is no conclusive evidence that the pain experienced by ME/CFS patients can be distinguished from that experienced by healthy people or those with other illnesses. Further, pain may be experienced in many areas, and while comprehensively assessing a patient’s pain symptoms is a challenging task, it is not specific to ME/CFS" (p 147).

Rejecting pain because it is non-specific ignores the fact that fatigue, exertion intolerance, sleep disorder, and the two optional symptoms are also not specific to ME/CFS. It also exhibits a failure to understand the basic physiology of pain. All pain is processed via the same neurological pathways, regardless of whether it is experienced by healthy people, or by people who are ill. Pain is a universal, and completely subjective, indicator that something is wrong in the body. The fact that so many people with ME/CFS experience pain cannot, and should not, be overlooked. To those who cannot escape it, the constant intractable pain of ME is an unbearable symptom, and can lead to addiction to painkillers, and, in some cases, suicide. Failing to include it as a significant feature of the illness basically relegates pain to "it's all in your head" (which, ironically, it is).

Exclusionary diagnoses not ruled out

Another major problem with the new criteria is that exclusionary diagnoses are no longer ruled out. Dr. Clayton was correct when she stated that there is nothing that says you can't get two conditions at the same time. You can have ME and hypothyroidism, or ME and cancer. Although Dr. Clayton was right in her assertion, a problem arises when you combine a lack of exclusionary diagnoses with a definition that requires only four non-specific symptoms. When patients present with these four symptoms, one of which is common to all diseases (fatigue), AND there is no requirement that illnesses that match those symptoms (leukemia, Hashimoto's, Ehlers-Danlos, MS, lupus) be ruled out, there is the danger that patients who are "zebras" will be misdiagnosed.

There is also the strong probability that patients with major depression (MD) will be simultaneously diagnosed with SEID, which will be a roadblock for researchers as well as patients. Depression is a catchall for busy physicians who are presented with patients who primarily report fatigue and sleep disturbance. (And when their doctors ask, "Do you exercise regularly?" sleep-deprived patients usually say, "No, I am too tired.") As a number of studies have shown, patients with MD do not test the same as patients with ME/CFS. Because MD is not excluded from the diagnostic criteria, and because, like ME/CFS, there is no biomarker for depression, these patients will be included in studies. Some will then be shown to improve with exercise and therapy. (But not all. Because depression is a symptom of many underlying illnesses - hypothyroidism, autoimmune disease, cancer, diabetes - patients diagnosed with depression don't necessarily improve with exercise, therapy, or antidepressants.) Meanwhile, patients with ME will mistakenly be given antidepressants, which will only make them worse.

To prevent medical mismanagement of ME any diagnostic criteria must exclude major depression. And to secure appropriate treatment for diseases that are treatable, illnesses with similar symptoms must be ruled out.

Pediatric definition same as adult definition

It is a mistake to use the same definition for children and adults.

Pediatric ME is not the same as adult ME. Hypersomnia (sleeping round the clock) is more common in children than in adults. Symptoms present in equal severity (particularly stomach and headaches). Listlessness, ADD-like symptoms, double vision and other visual disturbances. and fever are also more common than in adults. Because their immune systems are ramped up, flu-like symptoms persist for much longer in children than in the adult population. All of these symptoms are easily observed by parents.

Six months of undiagnosed illness in a child can be devastating. It is also crushing to children when adults accuse them of "making up" their illness. The consequences of disbelief on the part of medical professionals and officials are that children are maligned and dismissed, and possibly removed from their homes to be placed in psychiatric institutions or foster care, where they are forced to suffer exercise and deprivation regimes that only make their illness worse. Any definition of ME for children needs to take all of those factors and risks into account.

Bottom line

The IOM has described ME/CFS as a "serious, chronic, complex, multisystem disease," therefore it cannot, by its own description, reduce that "serious, complex" disease to four or five symptoms. To do so is a great disservice to the patients whose lives have been, and will continue to be, ruined by doctors who do not understand the illness, in part due to vague definitions.

What the IOM Should Have Done

Rather than invent a new definition, the IOM should have operationalized the algorithm devised by Jason's group, which has been tested and can identify patients with ME/CFS with 90% accuracy. The algorithm can be easily used by physicians as an initial screening tool once treatable conditions have been ruled out.

The second step in the diagnostic process should be the Canadian Case Definition, which not only provides enough detail to assess the illness, but utilizes the DePaul Symptom Questionnaire (DSQ) for additional information on severity and frequency of symptoms.

Until such time as we have a generally accepted biomarker, researchers should also rely on the CCC. It has been used in research for years, and has a verifiable track record.

The Absolutely Hideous

If the IOM failed in its charge to define the illness, it crashed and burned where naming it is concerned. Systemic Exertion Intolerance Disease is a name that means nothing. It is inappropriate, not just for this illness, but for any illness, for the following reasons:

1) All diseases are systemic, therefore the inclusion of "systemic" is meaningless. (The immune system, the endocrine system, and the nervous system all share cell receptors. Anything that affects one will affect the other two.)

2) "Exertion intolerance" will inevitably be translated into the more familiar term "exercise intolerance," which is seen in a number of illnesses. "Exertion intolerance" in this instance will be interpreted as either deconditioning or an "aversion" to exercise by general medical practitioners.

In addition to being useless, "SEID" represents a complete lack of familiarity with how diseases are normally named. Illnesses can be named according to a variety of traditions:
  • Place where the  illness was first identified: ex. Lyme Disease, Gulf War Illness
  • Person, or people, who first described the illness: ex. Guillain-Barre, Alzheimer's
  • Major organs or systems affected: ex. kidney disease, heart disease
  • Primary mechanism or process: ex. muscular dystrophy
  • Famous person with illness: ex. Lou Gehrig's
  • Historical continuity: ex. Malaria (which means "bad air")
Illnesses are never named after a single non-specific symptom. If they were, we would have Coughing Disease, Diarrhea Disease, Itchy Skin Disease. Naming this illness after a non-specific symptom is what has caused so much damage over the past three decades. "SEID" repeats the error, reducing an illness that is complex, of unknown or varied etiology, and with no generally accepted biomarker to a single non-specific symptom. "Exertion intolerance," in this context, is no better than "fatigue,"

(For those who are keeping track, this is the IOM's second naming fiasco in recent memory. The first was in 2012 when it re-named Gulf War Illness - another complex illness without an accepted biomarker - as "chronic multisymptom illness." Objections raised to that name ultimately culminated in a retraction.)

What the IOM Should Have Done

There were two viable options open to the IOM for naming this disease.

1) Keep the historical name myalgic encephalomyelitis. This would have lent continuity to both research and diagnosis. And, in spite of all protestations to the contrary, the name is accurate. The IOM itself stated that pain is "a defining characteristic of ME/CFS" (p 141). There is also clear evidence of CNS damage.

2) Call it Ramsay's Disease. This would have honored the first person to extensively describe, and treat, the illness, Dr. Melvin Ramsay, as well as putting to rest to all the arguments about whether there is or is not inflammation in the brain.

Other options (such as picking a few prominent symptoms out of the pile. e.g. "systemic-fatigue-sleep-disorder-exercise-intolerance-cognitive-impairment-disease") are not practical or medically accurate and should not be considered.

In sum: Be careful what you wish for

For decades patients and ME/CFS specialists have complained about the derogatory name "chronic fatigue syndrome." The discussion of what to call this disease has raged since the term CFS was first coined in the 1980s, leading many people to assume that no matter what you called this illness it had to be preferable to CFS. "Get rid of CFS," they said. "Anything is better."

Now we have a new name, and it is no better - possibly even a little worse - than CFS.

For years, physicians and researchers have said that the Fukuda definition is too broad, and captures patients with other illnesses. They devised a new definition, the CCC, which they used for 10 years. But, it was "too long." Now we have a new definition that is even more non-specific than the Fukuda definition, and, because the IOM does not rule out illnesses with overlapping symptoms, it will capture even more people without ME, making it useless for both diagnosis and research.

The IOM has lived up to the phrase "A camel is a horse designed by a committee." In the attempt to reach a consensus among bureaucrats, stakeholders and physicians, it has designed an ungainly beast.

To quote Jim Binns (chair of the Research Advisory Committee on Gulf War Veterans' Illnesses) after the IOM similarly failed in its charge to define GWI, "The conclusions of the report show that it was a waste of money. The committee never had the expertise or the process to do a case definition."

11 comments:

  1. Erica, this is a brilliantly supreme summation, thorough yet concise, with on-target points. Thank you for your deeply thoughtful review. ~ Victoria Bell

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  2. Thanks Erica. I think this article may prove very useful in helping those outside the USA get a better grasp on the situation.

    (This is Libby Boone by the way. Don't mean to leave an anonymous comment, but can't work out how to make that happen)

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  3. Hi Libby and Victoria. There are many more reasons why the IOM has failed to provide anything useful (other than a handy list of references), and indeed has set us back. Their steps for operationalizing their criteria consist entirely of rather vague questions. Objective tests were not recommended. The IOM is like a time machine - taking us back to 1984. (Or possibly 1954.)

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  4. Erica, thank you for this concise overview. It should be shared widely. I will be sharing it with the Spanish groups. I qm not up to translating right jow, so I hope Google will do a good job of translation.

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  5. Erica, great work. Easy to read and inciteful.

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  6. I think this review that brings up some interesting points that I hadn't thought of.

    There are a couple of things I have issues with though and I will focus on those.

    "A definition that is simplistic, undermining the statement that ME/CFS is a "complex, multi-system disease." -

    The "simple" criteria are mostly derived from statistical analyses which suggest that a) these criteria work and b) that including more symptoms aka the CCC runs the risk of plucking out a high percentage of patients with psychiatric disorders. Jason's algorthym only pertains to four symptoms - so I don't understand why there's an issue with the four/five symptoms chosen by the report. I was bit surprised that pain was not in there but the studies indicate that some people with ME/CFS don't experience pain and experience weakness instead. That's not my experience but I think that's why they did not include pain.

    The CCC does not include frequency/severity factors; Jason pointed out that it was because of that it can misdiagnose from 15-20% of healthy people as having ME/CFS. I do believe Jason has operationalized that definition, though, so that that is not an issue.

    The authors of the document - many of whom have decades of experience in ME/CFS - explained that idiopathic disorders like ME/CFS are often named according to their core symptoms. I don't particularly like the name but it does accurately describe the core symptom in ME/CFS and importantly, it should make doctors very wary about prescribing exercise.

    I disagree that myalgic encephalomyelitis accurately captures this disorder. Many people with ME/CFS have pain but the studies indicate that a significant subset do not find it to be a core feature and the evidence for encephalomyelitiis (inflammation in the brain) is very weak - probably because the technology is only now being developed that can spot the low levels of inflammation believed present. Perhaps in a couple of years, the name will be back but my guess is that the many other abnormalities found in the disorder will preclude a brain based name but we shall see. The authors were rightfully wary not to create a name that could be overturned by future research findings. I wouldn't be surprised if the autonomic nervous system and the blood vessels turns out to be the core issue in ME/CFS - and that might or might not fit with the ME label.

    I can see the allure of "Ramsey's Disease" and if we were in better shape in the medical community I would probably prefer that but with ME/CFS being so misunderstood I think it's good to have a name that describes the core symptom of the disorder. I would note that many of the ME/CFS (Klimas, Bateman, Natelson, Chu and I think Lerner was in there.) are or have been doctors - and I think they were primarily aiming the name at informing doctors about this disorder... I will trust them on that.

    The idea that "the IOM has failed to provide anything useful (other than a handy list of references)" - really? You had a list of good things in the document and then you just trashed the whole thing????? Do you really think Klimas, Bateman, Natelson, Ron Davis - for god's sake - and the others would take us back to 1984 or 54? I don;t think these people suddenly turned out to be complete idiots.

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  7. Hey there, Cort. I see we are going head to head on this.

    Have you read the section on operationalizing the definition? There are no tests, no objective measurements, and nothing of what Dr. Cheney or Dr. Peterson have used to successfully diagnose 20,000 patients. (Because both neurological and immune impairment are important, and they can interpret test results - as opposed to the physicians for whom the definition is intended.)

    Yes, if, you can see past the rhetoric, the IOM has rolled us back 20 years. It's important to distinguish between validating statements like "The disease is underfunded," and "This is a serious, complex disease" and actual concrete proposals, which, in the end, are the only things that matter. Unfortunately, a lot of people only listen to what they want to hear.

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    1. "Alot of people only want to listen to what they want to hear." So true, Erica. Cognitive bias is ever present, no matter what field of interest or endeavor one is engaged in.

      (Libby again.)

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  8. While I can see potential in this approach to a definition, I do not yet see a definition, let alone a clinical one, only a novel label which will interfere with literature searches.
    Yes, there were finally some people on the committee who could recognize the disease if it bit them. Given good faith, intelligent and knowledgeable people, money and time this could be made workable. Where is the evidence that such things will be available when required? (Except for time, which seems unlimited. I don't think anyone in government ever lost his/her job for delaying resolution of this medical problem.)

    No, nothing presented is a serious barrier to institutional incompetence, "benign neglect", disparaging interpretations, or -- most important -- delay. If we did not have the last 30 years of experience we might not have sound reasons to doubt. Producing a new definition which cannot use existing clinical experience guarantees delay while it is validated, and experience accumulated.

    We might focus all our frustration on individuals like the late Stephen Straus at NIH, who disseminated his personal opinions on pre-existing mental illness to news organizations even more widely than this report. Or we might concentrate on W.C. Reeves at CDC, who is famous for a number of pronouncements implicitly disavowed in this report. (Sample: "CFS does not occur in children.") This overlooks the fact that they were placed where they were by those organizations, and remained there, with all the support institutions provide, for many years. Age and mortality removed them, and the organizations involved still provide material reflecting their views to doctors. Whatever the faults of those individuals, they were not where they were by accident.

    This document is largely an exercise in public relations, for which powers that be must see a real need. The whole thrust of the document is outward, toward patient and public perceptions, you would have to work hard to realize that HHS, NIH and CDC made any missteps they need to correct. Why did decades of researchers use the Fukuda definition, if it was so flawed? Because the agencies funding research required it. Why did international groups of experienced clinicians feel the need to go to considerable effort to create, disseminate, validate and use a different definition? Because the Fukuda definition could mean anything in the hands of groups with diametrically opposed views. It was clinically useless.

    I'll add another twist to your criticism of exertional intolerance. Cardiologists already have a definition of exercise intolerance which allows them to write "patient shows good exercise tolerance" on charts before patients leave the clinic after a stress test on a treadmill. They don't have the foggiest idea what happens to patients afterward. By this interpretation, few of us would have exertional intolerance.

    At the other extreme, the report itself mentions publications in which 64% of patients with major depression showed "PEM", by their interpretation. Given published incidence for major depressive disorders, use of this interpretation in research could produce cohorts in which patients like those we now know would be a small minority.

    What we have now is an acronym, SEID, which may apply to something yet to be specified. What it actually means could be as misleading as price tags switched in a common form of shoplifting.

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    1. Cort, there is overwhelming evidence for encephalomyelitis in the disease I have endured for the past 26 years. Unfortunately, large and pertinent amounts of evidence were excluded from the purview of the IOM, which left them uncertain about that characteristic. The omissions in historic order:

      1. More that 30 years of pre-1988 data and research were excluded from the IOM purview. I refer to both U.K. and U.S. work, some of which cites encephalomyelitis or equivalents.
      2. Evidence of encephalomyelitis was deliberately excluded from Holmes’ report and definition and from Fukuda’s later work, and therefore was not available to IOM.
      3. Work presented at conferences was excluded from IOM purview. This does not show up in peer-reviewed journals for two reasons: a. The scientist has or had other goals and/or interests. b. It failed to be published because a key member of “CFS” peer review committees was systematically blackballing publication of biomedical evidence for the disease for more than a decade.
      4. Recent important work, such as that at Stanford, was not within the purview. One understands the limitations IOM faced, but that does tend to mean the report may be obsolete before the final printing. IOM might consider an appendix or even a one-author “note” on recent and ongoing science.
      5. Ample evidence within the scope of IOM points to probability of encephalomyelitis. E.g., cognitive dysfunction, “new and different” headaches. It has occurred to me that the “new and different” headaches may be reported by only 85% of reported populations because the CFS definition has swept in mis-diagnoses.
      6. Dr. Anthony Komaroff noted not long ago that the disease seems to involve a chronic sub-acute encephalitis. As the professional investigator of longest standing in the US and one who has served as both clinician and researcher Dr. Komaroff must be considered the expert par excellence.

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  9. This is WHO, Geneva's, policy on the use of eponyms and acronyms for ICD-11:

    http://www.who.int/classifications/icd/revision/Content_Model_Reference_Guide.January_2011.pdf

    ICD-11 Content Model Reference Guide - World Health Organization

    Page 59

    Use of Name of Noun formed after a person (eponyms)

    The naming of diseases after proper nouns or people (e.g. eponyms) are explicitly discouraged, except in historical cases where the eponym is already well-established (Alzheimer, Parkinson, etc.). However, eponyms can be entered into the tool as synonyms. Eponyms are used without the Genitive “’s”.

    Use of acronyms

    An acronym is an abbreviation formed from the first letters of other words and pronounced as a word (e.g. NASA). Acronyms may never be used for titles of categories. They should be added as synonyms to the appropriate spelt out disease entity thus facilitating identification of the relevant cases and categories.

    Suzy Chapman, Dx Revision Watch

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