Tuesday, February 10, 2015

Guest Post - IOM's S.E.I.D. and the W.H.O

While I digest the IOM's report released today, Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness, I'm posting the following preliminary comments on it on one specific issue from my friend and fellow advocate, Jerrold Spinhirne (with his permission, of course).  Thank you, Jerry!

2/11/15:  I've updated this post with more on this subject from Jerry below the original post.


The IOM "ME/CFS" report makes significant errors and misrepresentations regarding the international classification ME and CFS. On page 23, the report states:
In the World Health Organization’’s International Classification of Diseases, Tenth Revision, which will be implemented in October 2015, the clinical descriptions of ME and CFS are identical, yet ME is classified as a disorder of the neurologic system (ICD G93.3), while CFS is considered a synonym for chronic fatigue, which is classified under ““signs, symptoms, and abnormal clinical and laboratory findings, not elsewhere classified”” (ICDR53.82) [sic]. [1] [Emphasis added. Superscript reference given in brackets here.]
Reference 1 is:
The World Health Organization’’s International Classification of Diseases, Tenth Revision, can be accessed at http://www.icd10data.com/ICD10CM/Codes (accessed January 13, 2015).
In the first place, the ICD-10 referred to here is NOT the World Health Organization's ICD-10, but the US version, based on the WHO ICD-10, called ICD-10-CM. CM stands for "Clinical Modification." These limited modifications are made by individual countries following WHO guidelines. In the US, ICD-10-CM is produced by the National Center for Health Statistics, a part of the Centers for Disease Control. The official version of the 2015 ICD-10-CM can be downloaded from the CDC's website. http://www.cdc.gov/nchs/icd/icd10cm.htm#icd2015

The official ICD-10-CM tabular index does NOT include "clinical descriptions" of diagnostic terms – only the terms and their classification coding. What the IOM committee has done is to stumble upon a commercial website, ICD10Data.com, that adds clinical descriptions, gathered using software from various sources, to diagnostic terms. These clinical descriptions are added by the site owners, Alkaline Software, to help market use of the website to medical personnel to increase ad revenue. http://www.icd9data.com/AboutUs/ The clinical descriptions are not provided by the NCHS, the CDC, or any government agency.

The link given in the IOM report does not lead to the WHO "International Classification of Diseases, Tenth Revision," but to this unofficial, commercial version of the US ICD-10-CM. It is of no consequence that Alkaline Software has added "identical" clinical descriptions of ME and CFS to their commercial version of the ICD-10-CM. The published consensus case definitions of ME and CFS are indeed very different.

Based on this blunder, the IOM committee is recommending a new ICD code be added for their new "systemic exertion intolerance disease":
A new code should be assigned to this disorder [sic] in the International Classification of Diseases, Tenth Edition (ICD-10) [sic], that is not linked to ““chronic fatigue”” or ““neurasthenia.”" [Recommendation 1, page 7]
Myalgic encephalomyelitis has been classified as a neurological disease, G93.3, by the actual WHO ICD since 1969. On October 1, 2015, ICD-10-CM will become official in the US and also will include ME as G93.3 and specifically exclude CFS from the neurological disease classification. Both the 2005 CCC Overview and 2011 ICC specifically state the disease they define should be coded as G93.3 in the diseases of the nervous system section of the ICD. Neither the CCC nor ICC, developed by far more qualified panels than the IOM committee, considers ME as falling under any umbrella term that includes CFS patients without ME.

Instead of hiring the IOM to create a new unneeded, unclassifiable diagnosis with a silly-sounding name, all HHS needed to do was advise doctors to use the existing CCC or ME ICC to diagnose ME patients and code the diagnosis as ICD-10-CM G93.3 for billing and reporting purposes after October 1, 2015. Any US doctor credulous enough to consult the IOM report will receive no guidance on how to code a differential diagnosis of ME.

Jerrold Spinhirne, Facebook status update, posted 2/11/15:

The failure of the IOM ME/CFS committee to acknowledge the long-standing ICD code for myalgic encephalomyelitis as G93.3 in the diseases of the nervous system section of the WHO ICD means whatever disease the committee has defined, it is not ME. The committee, composed mostly of US non-experts from outside the field, wishes to create a new disease with a new ICD code, de novo, based on a literature review. This is absurd. The IOM committee lacks the standing and qualifications even to suggest such an outrageous undertaking.

Far more qualified independent international panels, composed entirely of experts, have clearly stated that the disease they are defining is ICD G93.3 myalgic encephalomyelitis. The 2003 CCC does not address the classification issue. However, the later CCC Overview summary does – as do the ME-ICC and IC Primer.

2005 CCC Overview, Page 1 under Classification:
ME/CFS is an acquired, organic, pathological, multi-system illness that occurs in both sporadic and epidemic forms. Myalgic Encephalomyelitis (ICD 10 G93.3), which includes CFS, is classified as a neurological disease in the World Health Organization's International Classification of Diseases (ICD).

2011 ME-ICC:
In view of more recent research and clinical experience that strongly point to widespread inflammation and multisystemic neuropathology, it is more appropriate and correct to use the term ‘myalgic encephalomyelitis’ (ME) because it indicates an underlying pathophysiology. It is also consistent with the neurological classification of ME in the World Health Organization’s International Classification of Diseases (ICD G93.3).

2012 IC Primer, Page 1:
Classification: Myalgic encephalomyelitis has been classified as a neurological disease by the WHO since 1969. WHO stipulates that the same condition cannot be classified to more than one rubric because, by definition, individual categories and subcategories must remain mutually exclusive. Thus, it is essential that patients meeting the ICC for ME are removed from overly inclusive groups. [In adjacent box.] Myalgic encephalomyelitis: neurological disease WHO ICD G93.3.

Failure of the IOM committee to acknowledge the established neurological classification of the disease ME and the committee's hubristic attempt to create a new disease with a new name and ICD code is absolutely unacceptable.

Tuesday, January 20, 2015

Let's Stop Preaching to the Choir

Watch this interview with a former ballet dancer felled by M.E.  Click on the "CC" below the video for subtitles if they don't pop up for you. 

If you're like me, you'll find it very moving.  This video relays an accurate description of M.E.  The problem?  It's being shared and seen by the M.E. community for the most part.  We are preaching to the choir. 

This is why we need to try something different to change public awareness of M.E.  This is why we need the help of new patient-driven initiatives like those of MEadvocacy.org which are dedicated to M.E.  

MEadvocacy.org has hired a public relations firm that will work for us at a steeply discounted rate to get media attention and provide healthy people to "stand in" for sick people who protest the U.S. Department of Health & Human Services' attempts to redefine M.E.  While patients, caregivers, family members, and friends have managed small demonstrations like this one, they have all been at great cost to the health of those involved.  

The firm started working January 1. More donations are necessary to finance its continuing work.  There is a $1000 matching challenge grant running until January 21, midnight EST. Anything donated, up to a total of $1000, will be doubled.  

Please don't stop donating past January 21. This is a six-month contract and the public relations work is just getting started. 

The IOM report will be coming out February 10.  The P2P is also wrapping up and may be completed in late January or early February. Continued funding is crucial to combat these two redefinitions. Please donate and/or encourage others to.   You'll be helping yourself as well as the M.E. community as a whole.

For more information and to donate to the public relations campaign, click on this link

Wednesday, December 17, 2014

Myalgic Encephalomyelitis International Consensus Primer Needs to be Distributed to Doctors

My friend and fellow advocate, Jerrold Spinhirne, eloquently points out the need for wide-spread education on Myalgic Encephalomyelitis (ME) and offers the right tool for the job. He asked me to post his treatise on the subject (originally posted as a Facebook note) here.

Why There Is an Urgent Need to Widely Distribute the Myalgic Encephalomyelitis International Consensus Primer to Doctors 

by Jerrold Spinhirne, December 17, 2014

The confusion and delay resulting from the recent December 9-10, 2014 National Institutes of Health (NIH ) Pathways to Prevention (P2P) Workshop on "ME/CFS" and the issuance of the Agency for Healthcare Research and Quality (AHRQ) Evidence Report No. 219 "Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome" [Smith, 2014] emphasize the urgent need for the 2011 Myalgic Encephalomyelitis: International Consensus Criteria (ICC) [Carruthers, 2011] and particularly the 2012 International Consensus Primer for Medical Practitioners (IC Primer or ICP) [Carruthers. 2012], to be widely distributed to doctors, medical personnel, medical professional organizations, medical schools, and hospitals in the US. The reasons why this is necessary are as follows:

Myalgic Encephalomyelitis Is Not a Fatigue Syndrome

Myalgic encephalomyelitis (ME) is a distinct neurological disease described in the medical literature since the 1930s [Gilliam, 1938] and recognized by the World Health Organization (WHO) since 1969. Classic descriptions of the disease, based on thousands of cases, [Acheson, 1959; Ramsay 1986] and the 2011 ME ICC [Carruthers, 2011] do NOT list unexplained fatigue, or any type of perceived, self-reported fatigue, as a diagnostically useful symptom of ME. Table 2 on page 14 of the AHRQ report [Smith, 2014] clearly shows that of the eight case definitions considered by the report, only the ME International Consensus Criteria case definition does not use fatigue as a criterion for diagnosis.

Indeed, people with ME do experience profound fatigue, but so do people with other serious neurological diseases such as multiple sclerosis (MS) and other forms of damage to the brain such as traumatic brain injury (TBI). Self-reported fatigue is a common feature of many medical diseases and psychiatric disorders, and, therefore, is not useful for making a differential diagnosis. Self-reported fatigue is a subjective and often retrospectively recalled experience that cannot be objectively measured. Self-reported fatigue can only be assessed using unreliable paper-and-pencil or computer-assisted questionnaires that produce highly variable and unstable results.

There is no research that indicates there is a correlation between changes in scores on fatigue questionnaires and changes in the underlying disease process of ME. Fatigue questionnaires, therefore, are of little or no use for measuring the effectiveness of various treatments for ME. CFS, on the other hand, is based on the subjective symptom of unexplained fatigue so an argument can be made that changes in fatigue scores indicate improvement or worsening of the condition in CFS-labeled patients or CFS-labeled research subjects.

Eliminating subjective fatigue as the defining characteristic and requiring a positive diagnosis based on objectively measurable features, as opposed to the CFS diagnosis of exclusion, further refutes the spurious claims that ME is based on medically unexplained symptoms (MUS) and can be considered a functional disorder or a "bodily distress syndrome." The authors of the ICC make a strong case, supported by published research, that ME symptoms are not medically unexplained and that ME cannot be considered a functional disorder without observable and measurable physical abnormalities.

According to the US Centers for Disease Control and Prevention (CDC), chronic fatigue syndrome (CFS) is a diagnosis of exclusion – that is, CFS cannot be diagnosed until all other diagnoses that may account for a patient's reported fatigue are ruled out. [Fukuda, 1994] No single patient, therefore, can simultaneously qualify for both a CFS and an ME diagnosis. In other words, ME and CFS are mutually exclusive diagnoses. If a patient meets diagnostic criteria for ME, he or she cannot rationally be diagnosed also with CFS because the ME diagnosis accounts for any fatigue reported by the patient – just as a cancer, rheumatoid arthritis, or multiple sclerosis diagnosis would do. However, how can doctors rule out ME, in keeping with the CDC's CFS diagnosis of exclusion concept, if doctors do not have reliable, peer-reviewed, up-to-date diagnostic guidelines exclusively for ME? 

Doctors in the US, therefore, need to have the IC Primer so they can make the differential diagnosis of ME rather than assign patients with ME to the broad, unexplained-fatigue-based diagnostic category of chronic fatigue syndrome.

The Term 'ME/CFS" Is Impossible to Interpret and Causes Confusion 

The mutual exclusivity of the ME and CFS diagnoses renders the term "ME/CFS," now favored by the US Department of Health and Human Services (HHS) and used throughout the AHRQ report, impossible to interpret. Does "ME/CFS" refer to only ME, only CFS, illogically both, or some other medical condition entirely? It is impossible to tell. No single patient can qualify for both diagnoses at the same time according to the separate case definitions for ME and CFS. [Carruthers, 2011; Fukuda, 1994] For this reason, the ICC and ICP call for ME patients to be removed from the overly inclusive CFS diagnostic category rather than to be placed in some logically incoherent, unclassifiable fatigue-based illness category called "ME/CFS" or "CFS/ME" This means that doctors need to reassess their existing CFS patients for ME using the IC Primer and, going forward, rule out ME before making any new CFS diagnoses.

How could the hybrid diagnostic term "ME/CFS" ever be classified following WHO rules and the basic principles of scientific taxonomy going back to Linnaeus and Aristotle? WHO rules do not allow any diagnostic term to be listed under more than one classification because, by definition, individual categories and subcategories must remain mutually exclusive.

ME is an established neurological disease listed in the WHO International Classification of Diseases (ICD) as benign myalgic encephalomyelitis under "Diseases of the nervous system" as G93.3 since 1969. Holmes-defined chronic fatigue syndrome [Holmes, 1988] was placed in the alphabetical index of the WHO ICD-10 in 1992 referenced to G93.3 in the tabular index. However, the WHO is silent on the relationship of alphabetical index terms to their referent in the tabular index. There is no reason to assume the WHO ever regarded the two terms, ME and CFS, as synonymous or equivalent.

In any case, it is clear that CFS has never been case-defined as a neurological disease, but only as a variable grouping of self-reported symptoms. Chronic fatigue syndrome was first defined as a fatigue-based research operational concept in 1988 by a CDC-led committee. [Holmes, 1988] CFS was later redefined in 1994 for further research purposes as a grouping of self-reported symptoms with 70 different variations by another CDC committee. [Fukuda, 1994] The authors of the 1994 Fukuda definitional paper did not consider CFS a neurological disease or, indeed, even a clinical entity until verified by further research.

Consistent with its 1994 CDC case definition, CFS is presently classified in the US ICD-9-CM (CM stands for clinical modification) as 780.71 under "Symptoms, Signs, And Ill-Defined Conditions." The US ICD-9-CM was written by the National Center for Health Statistics (NCHS), a part of the CDC, and on this basis must be considered authoritative for the classification of CDC-defined diagnostic terms. The current US ICD-9-CM does not list benign myalgic encephalomyelitis, deviating from the WHO ICD-9 on which it is based.

However, in the new US ICD-10-CM, official on October 1, 2015, benign myalgic encephalomyelitis is coded as G93.3 under "Diseases of the nervous system," as ME is now coded in WHO ICD-10. Chronic fatigue syndrome is specifically excluded from G93.3 in ICD-10-CM and coded, along with the symptom of unspecified chronic fatigue, as R53.82 under "Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified."

How then will US doctors code the hybrid diagnostic term "ME/CFS" using the new US ICD-10-CM? The term consists of the neurological disease ME in the G-section blended, in some indeterminable fashion, with the symptom grouping CFS in the R-section. In practice, doctors will have to chose to code an "ME/CFS" diagnosis as either CFS R53.82 or ME G93.3 rendering the hybrid term "ME/CFS" ambiguous and useless for reporting and billing purposes. US doctors however, are unlikely to use the ME code because the neurological disease ME is unfamiliar to them or has been misrepresented to them as another name for CFS. "ME/CFS" in practice will become only the symptom grouping CFS and not the neurological disease ME unless doctors are informed, using the IC Primer, how to differentiate ME from CFS.

Doctors Need Basic Information on ME to Avoid Harming Their Patients

Very few doctors in the US now have the information, training, and experience needed to recognize and diagnose ME. Doctors currently give the inappropriate broad diagnosis of CFS to their patients who have the neurological disease ME. The result is that CFS presently includes patients both with and without ME. The common CFS misdiagnosis creates a medically dangerous situation for patients with ME and greatly increases their risk of serious, or even permanent, iatrogenic harm. 

ME, according to the ICC, is characterized by an abnormal biological response to physical or mental exertion that the authors call post-exertional neuroimmune exhaustion (PENE). PENE is an objectively measurable, profound dysfunction of the body's neurological, immunological, cardiovascular, and energy-production systems that can result in prolonged, or permanent, disability. 

Iatrogenic harm to ME patients is especially likely now because the CDC and medical organizations informed by the CDC do not advise cautioning ME patients about the extreme risks posed by exercise. Instead, doctors are dangerously encouraging misdiagnosed ME patients to exercise or participate in so-called graded exercise therapy (GET) based on the CDC recommendations for CFS.

Without doubt, thousands of cases of extensive, or lifetime, disability in the US  result every year from the inability of doctors to recognize, diagnose, and properly treat ME. It is essential for the nation's health that US Department of Health and Human Services immediately begin informing doctors about ME and begin distributing the IC Primer to doctors before more people with ME are condemned to a lifetime of disability because of current unsafe medical advice and practices.

HHS has already had three years since the ICC were published in the Journal of Internal Medicine to inform doctors about ME and the grave risks to their patients caused by a missed ME diagnosis. HHS could easily and inexpensively begin almost immediately to advise doctors about ME by placing accurate information about ME on HHS websites with links to the ICC and IC Primer. 

The CDC has distributed thousands of printed copies of their CFS Toolkit [CDC, undated] to doctors. Every one of these doctors urgently needs to have also a printed copy of the IC Primer so he or she can recognize and diagnose ME and avoid causing harm to their ME patients by misdiagnosing them with CFS.

The CDC CFS Toolkit Places ME Patients At Risk

The diagnostic guidelines in the CFS Toolkit are based almost word-for-word on a 20-year-old CDC theoretical research case definition. [Fukuda, 1994] This research framework was designed to search for illness patterns that might indicate the presence an identifiable disease. No such distinct illness pattern has ever been found by the CDC. However, the CDC is still using their broad 1994 research criteria in the current CFS Toolkit as diagnostic criteria to assign patients to a hypothetical symptom complex called chronic fatigue syndrome that has come mistakenly to be regarded as a specific diagnosis. As a consequence, the umbrella CFS diagnostic category contains many missed differentiable and treatable diagnoses that were not sufficiently investigated before a patient was assigned to the general symptom CFS category. These missed diagnoses are then left medically untreated. Foremost of these missed diagnoses is myalgic encephalomyelitis.

Placing ME within the broad CFS category puts ME patients at risk because of the objectively measurable, abnormal biological response to exercise or exertion characteristic of the disease. Exercise that may benefit CFS-labeled patients solely with clinical depression or the single symptom of chronic fatigue may cause irreparable harm to patients with ME. The CFS Toolkit fails to list ME in the section "Illnesses that may resemble CFS" despite myalgic encephalomyelitis having been well-described in the medical literature for many decades and having been listed by the WHO ICD as a neurological disease for 45 years. Presumably, with ME now readily diagnosable by US doctors using the 2012 IC Primer, updates to the CFS Toolkit will list myalgic encephalomyelitis as an exclusionary disease for a CFS diagnosis.

The "Treatment and Management" portion of the CFS Toolkit, along with general platitudes on "coping skills, "emotional issues," sleep issues" and the treatment benefits of cognitive behavioral therapy (CBT) for "some patients with CFS," has a section on graded exercise therapy (GET). Graded exercise therapy is defined in the Toolkit as starting at a low basic level of exercise and gradually increasing "to a level where people can go about their daily life." 

The Toolkit also now states that, "The GET Guide 2008 by Chronic Fatigue Syndrome/ME Service at St. Bartholomew’s Hospital can be helpful in structuring your graded exercise plan." This unscientific and outdated guide is as unsafe for ME patients as the Toolkit. The GET Guide is now only available online archived at a Danish "functional disorders" website. The St. Bartholomew's Hospital GET Guide "aims to help you overcome limitations caused by the symptoms of chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME)" by gradually increasing exercise tolerance – similar to expecting diabetics to improve their sugar metabolism by gradually increasing their daily sugar intake.

Although the Toolkit warns to avoid "the push-crash cycle," no mention is made of the fundamentally altered biological response of people with ME to exercise and the possibility of increased disability and permanent relapse. In contrast, the IC Primer has a chart on pages 3 and 4 that lists 25 physiological functions in which the response of ME patients differs from the normal response.

Another grave risk posed for ME patients misdiagnosed using the CFS Toolkit rather the appropriate IC Primer is failure to recognize, monitor, and treat the serious known cardiovascular abnormalities associated with ME. The CFS Toolkit makes no mention of any cardiovascular problems whatsoever being associated with CFS. The IC Primer on page 6 lists with references these cardiovascular and autonomic impairments associated ME: 

Insufficient increase in blood pressure (BP) on exertion, low blood pressure and exaggerated diurnal variation may be due to abnormal blood pressure regulation, inverse relationship with fatigue, reduced blood flow and vasculopathy, arterial elasticity dysfunction – hyper-elasticity/contractibility of arterial walls, elevated response to acetylcholine, increased arterial wave reflection, ‘small heart’ with small left ventricular chamber, cardiac and left ventricular dysfunction, reduced heart rate variability during sleep suggests a pervasive state of nocturnal sympathetic hyper-vigilance and may contribute to poor sleep quality, low circulating erythrocyte volume (~ 70% of normal). Vascular abnormalities suggest there is insufficient circulating blood volume in the brain when in an upright position, and blood may pool in the extremities.

Doctors need to be aware of these serious possible cardiovascular impairments when treating and monitoring their ME patients. If an ME patient is given a CFS diagnosis and the CFS Toolkit is a doctor's only guidance, how would the doctor ever know to be alert for and treat these impairments?

Similarly, in each of the sections – Post-Exertional Neuroimmune Exhaustion, Neurological Abnormalities, Immune Impairments, and  Energy Production and Ion Transport Impairments – the ICP has detailed information useful for doctors, in contrast to the vague general information of the CFS Toolkit. The ICP has a step-by-step procedure for the ME diagnostic and reassessment process with checklists and charts to assist and guide doctors in the initial evaluation of patients, what medical tests to order, the diagnostic criteria, and how to monitor and reassess ME patients.

The IC Primer also lists over 30 medical laboratory tests and imaging studies specifically useful for the diagnosis and monitoring of ME, in addition to standard laboratory screening tests. The CFS Toolkit only recommends the standard laboratory tests to screen for other possible diagnoses based on the CDC's CFS as a diagnosis of exclusion concept. The IC Primer lists the 2-day cardiopulmonary exercise test (CPET) [VanNess, 2007] as an objective confirmation of the characteristic ME feature of an abnormal biological response to exertion. There is no objective test for the characteristic CFS feature of self-reported fatigue.

The IC Primer has extensive treatment recommendations for ME including specific pharmaceutical and extensive non-pharmaceutical treatments. The Toolkit "Drug therapies" section only gives general medication advice with no specific drugs mentioned. The section is mostly about what to avoid. The "Non-drug therapies" section includes, yoga, light exercise before bed, puzzles, and word games. 

Very importantly, the ICP has a sections on pediatric considerations and pediatric personalized ME treatment. ME presents differently in children and requires specialized treatment. Knowledge of ME in children by doctors can help prevent the abuse of children and their parents caused by psychiatric misdiagnosis and inappropriate psychiatric treatment of the neurological disease ME in children. Parents of children with ME are sometimes accused of encouraging illness symptoms in their children to gain attention and a sense of importance. The specific pediatric considerations and diagnostic procedures in the IC Primer can help counter this abuse of the parents of children with ME. The CFS Toolkit makes no mention of pediatric CFS.

The diagnostic guidelines of the ICP eliminates the arbitrary 6-month waiting period of the CDC criteria from when symptoms first appear and the condition can be diagnosed. It is critical that ME be diagnosed as soon as possible so patients can be advised they need total rest and to avoid exercise and overexertion. It may be too late for this medical advice after six months have passed. Early diagnosis and treatment result in the best prognosis and limits the risk of severe or permanent disability. Pioneer ME doctor A. Melvin Ramsay stated:

The clinical picture of myalgic encephalomyelitis has much in common with that of multiple sclerosis but, unlike the latter, the disease is not progressive and the prognosis should therefore be relatively good. However, this is largely dependent on the management of the patient in the early stages of the illness. Those who are given complete rest from the onset do well...

The IC Primer was written by 26 highly qualified expert authors, representing 12 countries, who have collectively diagnosed and treated over 50,000 patients with ME and have over 500 years of experience. The ICP is supported by published research with over 150 references.

In contrast, the CDC CFS Toolkit was written by anonymous authors who do not support their diagnostic and treatment guidelines with a single reference. Doctors and other medical providers are expected to take the recommendations of the CFS Toolkit on faith because it was written by employees of the CDC and has a photograph of a man in a white coat on the cover.

The Current HHS/IOM Redefinition of "ME/CFS" 

Instead of protecting the nation's health and economic viability by supporting and distributing the IC Primer, which is available for use free of charge, the US Department of Health and Human Services is unwisely creating more confusion, delay, and medical misinformation by hiring the unqualified Institute of Medicine (IOM) for $1,000,000 to oversee the creation of unneeded diagnostic guidelines for an unclassifiable new hybrid fatigue illness HHS is calling "ME/CFS."

The IOM is unqualified to create diagnostic guidelines for diseases because of its institutional conflict of interest and its unjustifiable policy of using panels composed mostly of inexperienced non-experts to develop diagnostic criteria. The HHS/IOM "ME/CFS" panel has eight non-experts and only seven members with significant knowledge and experience in the field. Of these seven experienced members on the panel, four have previously participated in CDC-organized continuing medical education courses recommending the use of the overly broad 1994 CDC CFS case definition and exercise as a treatment for CFS. The CDC online courses fail to acknowledge that ME is a separate neurological disease requiring its own case definition and diagnostic guidelines that caution against using exercise as a treatment.

How could the recommendations produced by an unqualified and inexperienced HHS/IOM panel possibly have more credibility, reliability, and utility than the recommendations of the existing ICC and IC Primer written by 26 expert authors with collectively over 500 years of experience in the field of ME? It would be utter folly and a tragic waste for HHS to place the recommendations of an unqualified and inexperienced IOM panel above the recommendations of the highly qualified expert ME ICC panel.

The diagnostic guidelines and treatment recommendation of the HHS/IOM "ME/CFS"  panel, composed mostly of neophyte, non-expert members, cannot possibly reduce the urgent need for wide distribution of the IC Primer for ME. Almost all of the worldwide experts on ME and CFS have agreed, on the record, that the product of the HHS/IOM "ME/CFS" panel will create more confusion, harm patient care, and impede future research. It is, therefore, vitally important for the reasons given above that doctors have the IC Primer now so they can recognize and diagnose ME and give their patients with ME the best chance to limit the disability caused by the disease and to provide ME patients the best quality of life until more effective treatments and a cure are found. 


Acheson, ED. The clinical syndrome variously called benign myalgic encephalomyelitis, 
Iceland disease and epidemic neuromyasthenia. Am J Med 1959; 26(4):569–595. http://www.name-us.org/DefintionsPages/DefinitionsArticles/Acheson1959.pdf

Carruthers BM, van de Sande MI et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011; 270:327–38. http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full

Carruthers BM, van de Sande MI et al. Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners. Published online October 2012. http://www.name-us.org/DefintionsPages/DefinitionsArticles/2012_ICC%20primer.pdf

Centers for Disease Control and Prevention. Chronic Fatigue Syndrome: A Toolkit for Providers. Undated. Accessed December 14, 2014. http://www.cdc.gov/cfs/pdf/cfs-

Fukuda K, Straus SE, Hickie I et al. Chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Intern Med 1994; 121: 953–9.

Gilliam, A. G. Epidemiological study on an epidemic, diagnosed as poliomyelitis, occurring among the personnel of Los Angeles County General Hospital during the summer of 1934. United States Treasury Department Public Health Service Public Health Bulletin, US Treasury Dept. No. 240. Washington, DC: United States Government Printing Office.1938.

Holmes GP, Kaplan JE, Gantz NM et al. Chronic fatigue syndrome: a working case definition. Ann Intern Med. 1988; 108:387-389.

Ramsay M. Myalgic Encephalomyelitis and Postviral Fatigue States: The saga of Royal Free disease. 1st ed. London: Gower Medical Publishing; 1986.

Smith MEB et al. Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No. 219. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 15-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality; December 2014. http://www.effectivehealthcare.ahrq.gov/ehc/products/586/2004/chronic-fatigue-report-141209.pdf

VanNess JM, Snell CR, Stevens SR. Diminished cardiopulmonary capacity during post-exertional malaise. J Chronic Fatigue Syndr 2007; 14: 77-85.

Wednesday, December 3, 2014

My Public Comment to the December 3-4, 2014 CFSAC Meeting

Note:  I submitted the following through the official channel (as an attachment uploaded to a website) before the 5 pm November 24 deadline. However, on December 2, after 5 pm, I received an email from the contractor informing me the attachment could not be opened.  I re-sent it as an email, but it's anybody's guess whether it will be read by its intended audience or posted on the CFSAC website (which is the main reason I wrote anything).


Here we are again.  I remember many years ago this Committee was referred to as the “sneering committee” due to the dismissive and derogatory treatment of patients and advocates by HHS ex-officio members.  

It appears nothing has changed.  In fact, the situation is worse than ever, with public appointees, including former patient representative Eileen Holderman, intimidated and threatened with eviction; with recommendations twisted and re-written to conform to HHS’ historic agenda for “CFS” as a subset of prolonged fatigue [1]; and with no regard for the disabilities those with ME and CFS  have.  (Surely the DFO must realize that this webinar and the five day notice period to submit public comments violates Section 508 and Section 504 of the Rehabilitation Act of 1973.)

The current CFSAC membership includes a nurse, an osteopath, and an educator.  Two of the doctors practice “integrative medicine” with a focus on mind-body medicine.  For the first time since 2003,  no lawyer has a seat at your table.  

The agenda for this meeting raises more questions than it answers, and leaves the public in the ridiculous position of commenting without knowing what the presentations consist of.  

Several make me apprehensive. While the development of Centers of Excellence (CoE)  has been recommended by the CFSAC for years, I question how an osteopath with his own “integrative” clinic “that attends not only to patient’s [sic] physical symptoms, but also addresses the root causes of an individual’s pain and illness, including problems of the mind and spirit that may be contributing to the disease process” [2] will do justice to this subject.  Will the Kaplan Clinic serve as a model for a CoE?  The thought makes me shudder. I don’t think it’s a coincidence that Dr. Kaplan will be presenting, nor that his clinic is reminiscent of the UK’s “CFS” clinics which focus on treatment with harmful Graded Exercise Treatment (GET) and Cognitive Behavioral Therapy (CBT).

Likewise, having a patient registry is a laudable goal and again, one previously recommended by the CFSAC.  However, how can one have a patient registry if HHS continues to use the broad, non-specific Fukuda criteria [1] and ignores the Canadian Consensus Definition [3]?  How can any researcher or clinician find useful information collected in a biobank composed of patients whose only commonality is the symptom of fatigue?  And why is the Solve ME/CFS Initiative (formerly known as the CFIDS Association of America) presenting on this topic?  There are other biobanks with stricter inclusion criteria that would be better suited for this purpose.

The P2P Workshop presentation by Robert Miller, a patient and self-appointed “patient advocate” does not inspire confidence either.  Thanks to Jeannette Burmeister’s successful FOIA lawsuit, we have seen NIH internal email correspondence and know that Mr. Miller was hand-picked by NIH as the “patient representative” on the P2P working group panel.  If there was a call for volunteers, no one I know of knew about it.  I know I speak for many in stating that Robert Miller does not represent the majority of knowledgable patients and patient advocates.

And let’s not forget HHS’ ex-officios’  most egregious act concerning those supposedly served by the CFSAC.

A clearly-phrased October 2012 CFSAC recommendation to “...convene ... at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome(CFS) experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition [3] for discussion purposes” has been hijacked. Instead, NIH and HHS ignored all patient and patient-oriented stakeholders and developed two redefinition “efforts” (the P2P workshop and the IOM “study”), neither of which comply with the letter or spirit of this recommendation. Rather, the focus of both is "medically unexplained fatigue". 

Surely you cannot be blind to the consensus letter from 50 expert researchers and clinicians to the HHS Secretary stating they have adopted the Canadian Consensus Definition [3] and will continue to refine and update it as scientific knowledge advances, including consideration of the 2011 Myalgic Encephalomyelitis International Consensus Criteria [4]?   What about the two petitions advocating for the adoption of the CCD and the cancelation of the  IOM study, signed by 7,666 stakeholders (as of this writing), the many letters sent to HHS officials against these redefinition efforts, the tweets urging you to stop the P2P?

The disease you should  focus on is Myalgic Encephalomyelitis, aka ME.  ME is already defined by the Canadian Consensus Criteria [3] as well as the 2011 M.E. International Consensus Criteria [4].  

It is a distinct disease officially recognized in the medical literature in the 1950s and classified in the WHO ICD under G93.3 (neurological diseases) since 1969.  The Centers for Disease Control and Prevention (CDC) recognized that "ME is accompanied by neurologic and muscular signs and has a case definition different from that of CFS" in its online medical education classes up until mid-2012 [5], and a 2010 CDC-authored, peer-reviewed research study acknowledged that "the physical findings in persons meeting the Canadian [Consensus] definition may signal the presence of a neurologic condition considered exclusionary for CFS". [6]  A 2011 study in England found a prevalence of 0.11% using the 2003 CCC, which, assuming a US population of 310 million, would result in about 340,000 ME cases, well below estimates for Fukuda-defined CFS. [7]

Yet HHS’ policy toward ME and CFS ignores all this.  It appears that Dr. Stephen Straus’ ghost still haunts NIH as his attitude toward those labeled with “CFS” continues to prevail at NIH.   The internal employee emails regarding the P2P, finally released in all their dismissive and derogatory glory, attest to that.  

All HHS employees involved in “CFS” or “ME/CFS” activities clearly need to become knowledgable in the subject matter they are working on and could do with some sensitivity training. I suggest the ME ICC as mandatory reading and recommend all view the film Voices from the Shadows. http://voicesfromtheshadowsfilm.co.uk/

  1. Fukuda K, Straus SE, Hickie I et al. Chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Intern Med 1994; 121: 953–9.
  2. The Kaplan Clinic website, http://www.kaplanclinic.com/about-the-kaplan-center/
  3. B. M. Carruthers, A. K. Jain, K. L. De Meirleir, D. L. Peterson, N. G. Klimas, and A. M. Lerner, Myalgic encephalomyelitis/chronic fatigue syndrome: Clinical working case definition, diagnostic and treatments protocols, Journal of Chronic Fatigue Syndrome, 11 (2003), 7–115.
  4. Carruthers BM, van de Sande MI et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011; 270:327–338.
  5. CDC-CME: A Primer for Allied Health Professionals, Course 3151, Chapter 1.  https://www.dropbox.com/s/ec4694d7ousuib1/CDC%20Course%203151B.png?dl=0
  6. Switzer WM, Jia H, Hohn O et al. Absence of evidence of Xenotropic Murine Leukemia Virus-related virus infection in persons with chronic fatigue syndrome and healthy controls in the United States. Retrovirology 2010 Jul 1;7(1):57
  7. Nacul et al. Prevalence of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in three regions of England: a repeated cross-sectional study in primary care. BMC Medicine 2011, 9:91, http://www.biomedcentral.com/content/pdf/1741-7015-9-91.pdf

Monday, October 20, 2014

Suggested Protest of the P2P

Note: I posted this in response to a discussion in the Facebook group, US Campaign for ME.  

UPDATE: As the deadline to post comments on the government website mentioned below has passed, feel free to use the sample comment provided as text for emails to the following. Make sure to keep copies of your sent emails.







This group’s focus from the start has been to oppose the three US government initiatives (including the P2P) to redefine ME and change the direction of research and clinical guidelines. We have been told by the government that P2P is part of the official response to the October 2012 CFSAC recommendation to convene a stakeholder workshop (including experts, patients, and advocates) to reach a consensus for a case definition, starting with the 2003 Canadian Consensus Criteria. We continue to support the experts and the CCC, as updated by the ME ICC.

As founders and administrators, we propose that members consider using the tool AHRQ has given us, a place to comment (by 11:59 pm EST October 20), in much the same way we used the public comment spaces at the January IOM meeting -- to protest the process rather than comment on the substance of the draft report. 

Videos of those who protested at the IOM are part of a permanent public record on the IOM’s YouTube channel. Similarly, the AHRQ must publish all public comments on its official government website. Thus, those comments (unlike letters sent to NIH Director Collins and others) will be accessible to the public at large and can be easily shared with the press, members of Congress, and others who need to see the truth: 

There is widespread dissent to what the U.S. government is doing to ME! Others are commenting on the substance of the report. We must counter their voices!

A protest comment can be pasted in the "General Comments" section of the AHRQ form, the last blank box toward the bottom of the page. There is no need to enter anything in the other boxes designed for more formal submissions. Comments can be anonymous.

Don't forget your comment must be submitted by 11:59 pm EST on Monday, October 20!

Feel free to copy and paste the sample comment below (don't forget to enter the years you've been sick) or use it for inspiration.

Click here to get to the AHRQ comment website. 


I am writing to protest the entire P2P process, including the production of the draft evidence report. I have had ME for ___ years and am outraged at the US Department of Health & Human Services’ (HHS) pretense that P2P is responsive to the Chronic Fatigue Syndrome Advisory Committee (CFSAC) October 2012 recommendation to convene a stakeholder workshop (including experts, patients, and advocates) to reach a consensus for a case definition useful for research, diagnosis, and treatment.

In no way is the P2P process responsive to this recommendation. NIH has not engaged or involved stakeholders in a substantive way. The Workshop panel consists of individuals with no expertise in ME or CFS. It ignores the subsequent letter to HHS by disease experts who have adopted the Canadian Case Definition for research, to be updated as needed. Instead, the focus of the draft report is "medically unexplained fatigue". 

By using evidence-based practice, the very research studies that could move the field forward are ignored. The report itself will unequivocally set back research and treatment and lead to continued harm to patients, quite possible worse than what has already been inflicted on people like me.

For these reasons, I object to the continuance of the P2P process, including publication of this report, its dissemination to the P2P panel, and its use for any other purposes.

Saturday, October 19, 2013

UPDATED ACTION! Tell Congress & the President to Cancel the IOM Contract & Adopt the CCC!

We must keep up the pressure to get the IOM contract cancelled and the CCC officially adopted by the U.S. Department of Health & Human Services.  

We must get our Congressional delegations to contact the key Senators and Representatives with jurisdiction over HHS -- the power to hold investigations, cut funding, and basically make the Department uncomfortable.  We must email the President, Vice President, and the President's science advisors. We must get HHS to listen and to ACT.

Remember, fifty ME/CFS experts stated in a letter to HHS,“[S]ince the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort (the IOM study) is unnecessary...Worse, this effort threatens 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.” (Emphasis added)
Our ME/CFS experts have spoken. HHS must follow their lead and adopt the CCC. HHS must cancel the IOM contract as wasteful, unnecessary and harmful. 
For U.S. residents only:  
Please contact your congressional delegation as soon as possible and ask them to contact these congressional leaders to tell HHS to adopt the CCC and cancel the IOM contract. Please ask your family and network to do the same. 
Instructions and a sample letter are below.  

For everybody - U.S. and international members of the community:
Please contact the President’s science advisors as well as the President and Vice President today and ask them to tell HHS to adopt the CCC and cancel the IOM contract. Directions are below.
Also, if you have not done so, please sign the following two petitions calling on HHS to adopt the CCC and cancel the IOM contract. Ask your family and friends to do the same. 
  1. October 7, 2013 petition calling on HHS to stop the HHS/IOM contract and accept the CCC definition - http://bit.ly/GUedsp 
  2. June 2013 petition calling on HHS to adopt the CCC and stop using the name ‘chronic fatigue syndrome’   http://www.thepetitionsite.com/255/349/958/fatigue-is-not-a-disease/
Instructions to Email or Call Your Congressional Delegation (U.S. only)
  1. Senators and members of the House of Representatives need to hear directly from their constituents. You can get the contact information for your congressional delegation at this website:
Type your zip code into the form and click on “Submit It”. The website will return the names of your two senators and one representative along with their phone numbers and a link to their contact form.    
  1. Click on the link to the web contact form for your senators and representative. This will bring up the web contact form for that legislative leader. 
    1. If you are using the sample letter, copy it into the box provided for your message. 
    2. Use “Stop the IOM Contract to Redefine ME/CFS" as the subject. 
    3. Select a choice dealing with healthcare if needed.

Sample Message 
To be copied into the web contact form:
I am asking you to contact one or more of the following Senators and Representatives who chair committees with jurisdiction over the Department of Health and Human Services (HHS):  Senators Harkin, Murray, Alexander, Mikulksi, Shelby, Sanders, and Burr; and Representatives Upton, Kingston, Pitts, Pallone, DeLaura, Rogers, and Lowey, on my behalf.  Ask them to contact HHS today and tell Department to follow the lead of Myalgic Encephalomyeltis/Chronic Fatigue Syndrome (ME/CFS) disease experts. Ask them to tell HHS to adopt the Canadian Consensus Criteria and cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS.
Fifty of the leading ME/CFS researchers and clinicians have written to HHS Secretary Kathleen Sebelius calling for the Canadian Consensus Criteria (CCC) to be used as the sole case definition for ME/CFS. These experts also urged HHS to abandon its plans to contract with the Institute of Medicine (IOM) to use non-experts to create its own definition. On the same day, despite an outpouring of patient opposition, HHS announced that it was going forward with the IOM contract to develop its own clinical diagnostic criteria for ME/CFS, instead of adopting the 2003 Canadian Consensus Criteria (CCC) created and endorsed by ME/CFS experts. 
Regarding the IOM contract, the fifty experts stated,“[S]ince the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort (the IOM study) is unnecessary ... Worse, this effort threatens 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.”
The use of non-experts is especially concerning because, thanks to the bad definitions that HHS has promoted, the disease is so poorly understood that the medical community at large believes the disease is either not real or is a form of depression or deconditioning. ME/CFS is not deconditioning or depression. It is a devastating disease that causes neurological and immunological dysfunction and leaves patients bedridden, housebound and unable to work. ME/CFS costs the U.S. economy an estimated $17-23 billion dollars a year in lost productivity and direct medical costs. 
Given the overwhelming opposition to HHS’ plans by both patients and experts, I am asking you to do whatever you can to get HHS  to follow the lead of ME/CFS disease experts. HHS must cancel the contract with IOM.  HHS must  adopt the Canadian Consensus Criteria.
For more information, see the following links or send an email to meactnow@yahoo.com.

Instructions for Contacting President Obama’s Science Advisors, President Obama, and Vice President Biden:

  1. Copy and paste all but the first paragraph of the sample message below into the body of the content form.  
  2. Substitute "Please order HHS to adopt the Canadian Consensus Criteria and cancel its contract with the Institute of Medicine (IOM) to redefine ME/CFS." for the first paragraph.
  3. Send the modified email to the President's science advisors: pcast@ostp.gov (cc meactnow@yahoo.com). 
  4. Some of these emails are bouncing back.  The President has 18 PCAST advisors.  Just in case they are not receiving the message, use  the form at http://www.whitehouse.gov/administration/eop/ostp/contactusScroll down to “PCAST” on the menu and fill out the rest of the required information. Copy and paste the modified message for the body of the content form.
  5. Go to http://www.whitehouse.gov/contact/submit-questions-and-comments, check "Health & Human Services" for the subject,  and copy and paste the modified message to President Obama and Vice President Biden.

      Background Information (not to be included in the sample letter)  

      Note: For those who are telephoning or meeting with their Congressional delegations, the following also are fodder for talking points.

      On September 23, HHS announced that it had engaged the Institute of Medicine (IOM) to develop “clinical diagnostic criteria” for ME/CFS. That announcement can be found here: http://bit.ly/18m7XlJ

      The same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) sent an open letter to Health and Human Services (HHS) Secretary Kathleen Sebelius announcing they have reached a consensus on adopting the Canadian Consensus Criteria (CCC), calling on HHS to adopt the CCC as the sole definition for ME/CFS and urging HHS to abandon its plans to develop its own diagnostic criteria. Fifteen additional experts added their signatures to this letter in October. The letter can be found here: http://bit.ly/15npS9B

      General background can be found here http://bit.ly/16qOLY3

      Additional facts about the HHS/IOM contract for ME/CFS can be found here – http://bit.ly/1hIz4ej 

      Ask to join the Facebook group, U.S. Campaign for Myalgic Encephalomyelitis (M.E.), for updates and additional ideas. 

      Saturday, September 28, 2013

      One Heck of an Inspiring anti-IOM Study Letter

      Read this letter.  It spells out  all the issues and connects the dots.  The author has granted permission to share it.  I hope it inspires you as much as it has me. 

      Dear Secretary Sibelius, Dr. Koh,  Dr. Maier, Dr. Unger, Dr. Lee, Dr. Fineberg, and Dr. Behney,

      As a physician, health services researcher, and person affected by myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS), I am writing to you today to request that you consider strongly the letter expert ME/CFS scientists and physicians sent September 23, 2013 and cancel the Department of Health and Human Services’ contract with the Institute of Medicine (IOM) to construct a clinical case definition for ME/CFS. While I am appreciative of DHHS’ continued interest in ME/CFS and recognize the important and influential role the IOM plays in the health of the nation, I believe that the money and resources spent on such a contract might not only be duplicative and better spent on other areas of ME/CFS research  but may end up being harmful to patients in the short-term, by subjecting them to inappropriate treatments, and in the long-term, by obstructing and obscuring research progress.  Patients, patient advocates, clinicians, and researchers understand these issues and thus, rather than greeting the contract with joy and enthusiasm  expected, are instead contacting you with their concerns.

      Duplicative efforts will waste time, resources, and money

      1) Over the decades, a number of different clinical case definitions from different countries have been proposed for ME/CFS. Expert clinicians and researchers have reviewed all of them, found many to be unsatisfactory in describing patients, and, thus, came up with two different consensus-based definitions in the last decade, the Canadian Consensus Criteria (CCC, 2003) and the Myalgic Encephalomyelitis - International Consensus Criteria (ME-ICC, 2011). The experts recognize that both the CCC and ME-ICC need further validation and refinement but agree that these definitions are adequate enough to be used NOW both for clinical and research purposes. Indeed, use of the CCC has already yielded a possible treatment, rituximab, for some patients via a successful small trial in Norway. 

      2) DHHS’ own CFS Advisory Committee (CFSAC), recommended in October 2012 that “at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates) workshop  in consultation with CFSAC members [be convened] to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.” CFSAC did not ask for separate meetings to construct separate clinical and research definitions but for meetings to construct a case definition useful for multiple purposes. 

      3) Several studies, including the Centers for Disease Control and Prevention’s Multi-Site Clinical Assessment Study, and a meeting, an Evidence-based Methodology Workshop, are already being planned by the National Institutes of Health to address the issue of case definitions. It is unclear how IOM involvement would add value to the processes already underway. Instead too many cooks may spoil the broth. 

      4) Whenever patients, clinicians, researchers, advocates, or CFSAC have asked for increased funds for ME/CFS research and care, like for a Request for Applications (RFA) or for a Center of Excellence, they are told that there is no money. Yet, DHHS has money now to spend on a meeting rather than these repeated worthwhile requests? 

      Separate research/ clinical case definitions are harmful to patients, obstructive/ destructive to research efforts

      The last 3 decades have demonstrated that the separation of clinical care and research has resulted in suboptimal, even harmful care, of patients and little progress in our understanding of the cause(s) of and treatment for ME/CFS.

      As shown recently by the US Food and Drug Administration’s excellent final report from their ME/CFS Drug Development Workshop (The Voice of the Patient), post-exertional malaise (PEM),  exacerbation of all ME/CFS symptoms (including pain, exhaustion, sore throat, insomnia, cognitive problems, etc.) with mild physical/ cognitive activity, is a key feature and disabling symptom of ME/CFS. PEM, not chronic fatigue, is why patients are bedridden, homebound, unemployed, and unable to walk a block. Clinicians from around the globe who see and take care of thousands of ME/CFS patients regularly are well aware of this symptom and thus chose it as a required symptom when constructing both the CCC and ME-ICC.  The management of PEM is also different from chronic fatigue; rather than push patients to ignore PEM and to continue to engage in mental or physical activity, which could result in not only temporary but prolonged disability, experienced clinicians tell patients to balance their activity with rest to decrease the onset or severity of PEM. 

      In contrast, the emphasis on fatigue by the 1994 Fukuda and other case definitions promote the image of ME/CFS as a benign illness that can be overcome merely by a positive attitude, increased exercise, healthy diet, and enough sleep. This is reinforced by  European-based clinical trials of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) that claim to substantially improve the health of or even cure ME/CFS patients. These are double-blind randomized placebo-controlled clinical trials so they must be the best and last word in care, right? This treatment information is distributed widely in usually trusted resources such as the online medical database UpToDate.  Yet a careful reading of those trials shows that frequently, subjects were selected primarily because of chronic fatigue and that a common primary outcome measure was fatigue reduction. PEM was neither required for subject selection nor measured as an outcome. (Aside from the fact that none of the trials report objective increases in activity, for example, via actigraphy.) 

      Consequently, when the results of those trials are applied in practice to patients with symptoms beyond only chronic fatigue,  over  50% of thousands of patients surveyed over the last decade have stated that those treatments made them worse, not better. Patients who follow their physicians’ directions faithfully have ended up bedridden, some for days, others for years. The most recent IOM contract announcement mentions the 2007 NICE Guidelines for CFS/ME from the United Kingdom, where CBT and GET are mainstays of treatment.  The NICE guidelines were not deemed to be “nice” but rather “unfit for purpose” by the ME Association and UK patients, who asked for a  judicial review of that document. When the majority of people receiving a treatment are not getting better or even getting worse, we should ask WHY, not cling to the results of trials and doubt the words and experiences of patients. 

      Because most physicians are not educated about PEM and the limits of GET/ CBT trials, patients who do not improve substantially with or defer CBT or GET are either blamed for non-compliance or viewed as depressed, malingerers, or hypochondriacs.  In 2011,  the Centers for Disease Control and Prevention reported that 85% of clinicians still viewed ME/CFS as a wholly (14%) or partially psychiatric disorder (71%).  A quarter of clinicians recommended referral to a psychologist as an initial treatment. This perception, coupled with lack of knowledge, is why hundreds of thousands of patients all over the United States cannot find a single knowledgeable and sympathetic physician to take care of them. It doesn’t matter if the patient visits Dr. “Average” at a rural private practice clinic or Dr. “Expert” at a metropolitan internationally respected university medical center. The attitude displayed and advice given is rarely different; when choosing “experts”, even those selected for their methodological/ analytic rather than clinical/ basic science skills, will DHHS or IOM consider screening for knowledge about or attitudes towards ME/CFS? Will those who view it as a primarily psychological or psychiatric illness be screened out? I understand  that the current IOM Gulf War Illness panel is currently facing criticism from Gulf War veterans and even from the chairman of the GWI advisory committee, Jim Binns, that the panel includes members who don't think GWI is a physical illness. Will any ME/CFS IOM committee have the same problem?

      This history is largely why I and other patients, now joined by expert clinicians and researchers, experience a collective shudder of fear and horror when they hear DHHS plans to a) construct a clinical case definition employing professionals unfamiliar with ME/CFS, b) separate from a research case definition, c) at several separate meetings no less. ME/CFS’s past is filled with examples of ineffective and harmful ideas and treatments visited upon patients without listening to their stories nor to those of the clinicians taking care of them. Confusion and harm has already been incurred by applying research based on one definition (e.g. Oxford-based PACE trials) to patients diagnosed with another definition (Fukuda) and by employing a research case definition (Fukuda), without a solid clinical grounding, that focuses on the wrong symptom. Why make that same mistake again?

      We now have two  case definitions, CCC and ME-ICC,  vetted by experienced clinicians that are already being used in both practice and research. I see no need to waste further time, money, or energy on another consensus-based meeting when those resources could be better used to validate/ refine these definitions or find biomarkers, diagnostic tests, or treatments. Patients’ lives are passing by each minute, never to be regained;  don’t make us to wait another 3 decades!

      Thank you for your attention, 
      Lily Chu, MD, MSHS, 
      Burlingame, CA

      (bolded text by the author)