Wednesday, July 22, 2015

NIH Seeks Public Input on Strategic Plan

In response to at request from Congress, the U.S. National Institutes of Health (NIH) is developing a 5-year strategic plan which will, among other things, set research priorities based on burden of illness.

While this plan is not meant to be disease-specific, it assumes all diseases are covered in the strategic plan of NIH's myriad Institutes, Centers, and Offices (ICOs). The National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Neurological Disorders and Stroke  (NINDS) are examples of ICOs.

Of note, M.E. is not part of any ICO strategic plan.  M.E., unlike other diseases, does not have a home in a major Institute like NINDS or NIAID.  Instead, it is housed in the Office of Research on Women's Health (ORWH).  ORWH's last strategic plan, which covers all years up to 2020, does not even mention "chronic fatigue syndrome" let alone M.E.

Funding for M.E. is an astonishingly low $5 million, way below other diseases and especially absurd considering the CDC estimates its illness burden (overall cost to the economy) at $17-24 billion.

Public input is requested.  Both of the above points are worth bringing up. The deadline for comments is August 16th.  This is a great opportunity to make constructive arguments for including M.E. in the overall NIH plan.

Using the comments section, especially the last part entitled "Future opportunities or emerging research needs" can only highlight the need for M.E. research.

Let's let NIH know we are fed up with being forgotten! Click on the link for more information and the public comment form.

ETA:  I just found out NIH is hosting a webinar open to the public on the NIH Strategic Plan at 4 pm EDT on Thursday, August 13.  Click here to register:

Monday, March 2, 2015

HHS to IOM: New Clinical Diagnostic Criteria for ME/CFS Not Necessary

On February 10, the Institute of Medicine (IOM) released a report,  Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness,  in response to a request from the U.S. Department of Health & Human Services (HHS). But was the report truly responsive to the request?

Specifically, HHS’ task order (aka charge) asked the IOM to:

  • Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, 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; 
  • Develop an outreach strategy to disseminate the definition nationwide to health professionals. (IOM, 2015, p. 14)

However, this was not the only information the IOM committee received regarding its task.  During the committee’s first public meeting, Deputy Assistant Secretary for Health, Dr. Nancy Lee (representing the study’s sponsors), briefed the committee in more detail. (Lee, Background and Charge to the Committee, IOM video, January 31, 2014.)

Specifically, she noted “for the purposes of this study, HHS uses “ME/CFS” to refer to conditions that include Myalgic Encephalomyelitis [ME], Chronic Fatigue Syndrome [CFS], Chronic Fatigue and Immune Dysfunction Syndrome, Neuro-Endocrine Immune Disorders, as well as other terminologies. These may be distinct disease entities, part of a spectrum, or a similar phenotypic response to a variety of external and internal assaults on the individual.”  (Lee video, 1:52-2:23) (emphasis added).

According to Dr. Lee, “the Committee may well decide that different criteria are needed for different disease entities that fall under the broad umbrella of ME/CFS.  This could help health care providers distinguish between these different conditions,” (5:40) adding that “[notably, there is a debate whether ME and CFS are distinct entities or different names for the same or similar syndromes.” (5:54).

In response to a question from one of the IOM panelists, Dr. Lee stated that the committee could recommend the use of existing definitions rather than come up with a new one. (14:00-15:05) This relates to the second stated task, “Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology”.  In other words, the committee was under no obligation to create new diagnostic criteria.

So why weren’t ME and CFS separated?

Despite this briefing, the committee abandoned ME and instead chose to focus on the chimera of ME/CFS with little rationale. Note there is no disease or syndrome associated with the nomenclature, ME/CFS.  Whatever meaning is ascribed to ME/CFS is imposed on it by the reader and therefore varies tremendously. 

The report gives short shrift to the history of ME and CFS (pp. 23-25).   The importance of the Lake Tahoe, Nevada and Lyndonville, NY outbreaks in the mid-1980s and how they were greeted by the Centers of Disease Control (CDC) and the National Institutes of Health (NIH) are only touched on.  The significance of the CDC’s cursory investigation of the Lake Tahoe outbreak (considered by experts an ME outbreak) and the subsequent critical disappearance of ME via the 1988 Holmes criteria for CFS is marginalized in the report. 

There is a rather odd citation to a 1991 publication by Stephen Straus, lead investigator of CFS at the NIH at the time (p. 24; Straus, 1991).  Straus, who essentially controlled CFS research at NIH, is on record stating “this syndrome...reflects an excessive risk for educated adult white women...[with] histories of unachievable ambition, poor coping skills, and somatic complaints” (Strauss, 1988) and  “[t]hese patients are cerebral people who spend a lot of time considering their symptomatology.” (Hales, 1987).  Once he dismissed EBV as a causal agent and his small treatment study using Acyclovir did not prove fruitful, Straus, while subsuming historic ME into CFS, increasingly spoke and wrote of CFS as a psychological disease, an attitude that remains highly prevalent at NIH to this day.

Surprisingly, despite this well-known history (which is not addressed in the report) there is a reference to “the relatively limited research efforts to study ME” (p. 24). It would have helped if the committee had mentioned the 1992 investigation of the Lake Tahoe cohort  by non-governmental researchers in this part of the report. (Buchwald et al., 1992).  As referenced on p. 132 in the section dealing with infections and ME/CFS, this Harvard-led research team found abnormal MRI brain scans, significant alterations in white blood cells counts and functioning, and signs of active infection with a recently discovered pathogen, HHV-6a. The illness was recognized as a chronic, immunologically mediated inflammatory process of the central nervous system.  This contradicted the CDC’s studies on the same cohort.

The committee also failed to take into account how the NIH climate affected the research produced once CFS was coined and defined (and redefined via the 1994 Fukuda criteria).  Funding opportunities were rare, small, and geared toward psycho-social research and the grant review panels tended to be made up of individuals biased against biomedical (especially immune or infection related) proposals.  This resulted in the starvation of promising research and a rise in research on fatigue, co-morbid conditions, psychology, and general pain.  

The committee apparently did not find sufficient evidence to support ME as a distinct diagnosis.  But the panel’s methodology for review of the literature, no matter how robust and well-intentioned (pp. 17-20), is built on a skewed evidence base due to the above-referenced history.  Of course there is  little research on ME to be found. Most of it is dated and descriptive, and evidence of important symptoms, signs, and potential biomarkers is hidden in research labeled CFS or ME/CFS. Much literature on ME was missed, as the committee assumed reviewing papers published during the past 10 years would catch older research in the introduction and discussion  sections. (p. 19, fn.). And, as the authors repeatedly note, use of various definitions and patient cohorts has lead to incomparable research.   Clearly, an evidence-based review is simply not suitable for a disease as politicized (and, as a result, understudied) as historic ME, named and defined as far back 1956, with outbreaks going back to 1934, and updated by the 2011 International Consensus Criteria for ME (ME ICC; Carruthers et al., Criteria, 2011).

So how can any conclusions be drawn?  Faced with a similar quandary for its Gulf War Veterans report, the IOM decided that evidence for a new case definition was lacking to date and recommended the use of two pre-existing criteria. (IOM, 2014).  ME/CFS has several definitions, as noted by Dr. Lee and the panel.  SEID appears to be an unwieldy melding of parts of Fukuda CFS and some CCC criteria.  Why not leave CFS as defined by Fukuda and ME as defined by the most current criteria, the ME ICC? 

The 2011 ME ICC  and its accompanying primer (Carruthers et al, Primer, 2012) were reviewed according to the  report’s references, but little mention of their dismissal as ME criteria can be found.  When ME is mentioned, it is in the context of a proposed new name for ME/CFS (pp. 9, 14, 51).  Of note, however, the  committee recognized that “the diagnostic criteria for ME have required the presence of specific or different symptoms from those required by the diagnostic criteria for CFS; thus, a diagnosis of CFS is not equivalent to a diagnosis of ME.” (p. 51).  This is exactly what Dr. Lee was driving at.

By proceeding with a literature search and input from clinicians familiar with and patients diagnosed with various forms of ME/CFS,  the committee decided it had sufficient evidence to target symptoms and signs for a new definition. Refusing to acknowledge that the evidence base was flawed, it came up with Systemic Exertion Intolerance Disease, aka SEID.  In constructing SEID, the panel ignored that they were dealing with a very real disease, ME, and a social construct, ME/CFS.

SEID is not ME.  ME is much more complex than the SEID criteria (and includes exclusion criteria), and the  ME IC Primer point to biomarkers, not subjective questionnaires, to help clinicians diagnose the disease.  ME can never be the name for the IOM committee’s new creation, SEID, as ME already is linked to a disease.  Comments that the name, Myalgic Encephalomyelitis, is not supported by evidence ignores that disease names do not have to be perfect to be useful.  A disease like ME linked to substantive and historical diagnostic criteria for over half a century cannot be “disappeared”.

The consensus-based ME ICC deserves to be recognized as most up-to-date criteria for those who meet its definition.  As the ME IC Primer states, “ Myalgic encephalomyelitis, a name that originated in the 1950s, is the most accurate and appropriate name because it reflects the underlying multi-system pathophysiology of the disease.  Our panel strongly recommends that only the name ‘myalgic encephalomyelitis’ be used to identify patients meeting the ICC because a distinctive disease entity should have one name.  Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification” (p. ii).

Distributing the ME iCC criteria to clinicians is not difficult.  The ME IC Primer includes a three-page clinical assessment and diagnostic worksheet (pp. 10-11) which may be copied and used by practitioners.   The Primer itself can be downloaded from a number of sites and purchased in pamphlet form from the UK group, Invest in ME.   HHS and other non-governmental organizations have the resources to do  develop a dissemination strategy, based on the IOM panel’s recommendations toward the end of its report.  Even individual patients can bring the worksheet or Primer to their office visits. 

It’s not that complex.  The disease ME, however, is complex.  


Buchwald, D., Cheney, P., Peterson, D., Henry, B., Wormsley, S., Geiger, A., Ablashi, D., Komaroff, D. et al. 1992. A chronic illness characterized by fatigue, neurologic and immunologic disorders, and active Human Herpesvirus Type 6 Infection. Annals of Internal Medicine 1116: 103-13

Carruthers BM, van de Sande MI et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011; 270:327–38. 

Carruthers BM, van de Sande MI et al. Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners. Published online October 2012. (pamphlets for purchase available toward bottom of

Institute of Medicine. 2015. Beyond myalgic encephalomyelitis/chronic fatigue syndrome: Redefining an illness. Washington, DC: The National Academies Press.

Institute of Medicine. 2014. Chronic Multisymptom Illness in Gulf War Veterans: Case Definitions Reexamined. Washington, DC: The National Academies Press.

Lee, Nancy, Background and Charge to the Committee, IOM video, January 31, 2014,

Hales, Diane. “The Epstein-barr Virus May Be In Vogue Among Yuppies, But Doctors Find It Hopelessly Vague”, American Health Magazine-Washington Post Writers Group. 13 May 1987.

Straus, S. E. 1988. Allergy and the Chronic Fatigue Syndrome. Journal of Allergy and Clinical Immunology. 81: 791-95.

Straus, S. E. 1991. History of chronic fatigue syndrome. Reviews of Infectious Diseases 13 (Suppl. 1): S2-S7.

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 (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.

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,, 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. 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 which are dedicated to M.E. 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