In 2017, the Centers for Disease Control and Prevention (CDC) adopted new diagnostic criteria developed by the Institute of Medicine (IOM, now renamed the National Academy of Medicine) to replace the CDC’s previous diagnostic criteria for chronic fatigue syndrome (CFS) based on the 1994 Fukuda research definition of CFS.
The new IOM criteria are to be used to diagnose what the CDC is now calling
“ME/CFS” and the 2015 IOM report calls “systemic exertion intolerance disease” (SEID). To avoid confusion with “ME/CFS” as diagnosed by the more specific 2003 Canadian Consensus Criteria (CCC), the new CDC IOM diagnosis will be called “SEID” here.
The CDC adopted the IOM SEID diagnostic criteria before it had been validated by independent research. Research done by Leonard Jason’s group at DePaul University, rather than validating the IOM criteria, suggests that because the four required SEID symptoms are commonly reported by patients with a variety of medical and psychiatric disorders, SEID is, in fact, not a distinct disease, despite its name.
“The findings indicate that many individuals from major depressive disorder illness groups as well as other medical illnesses were categorized as having SEID. The past CFS Fukuda et al. prevalence rate in a community based sample of 0.42 increased by 2.8 times with the new SEID criteria.”
(From Jason et al. “Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease.” http://www.mdpi.com/2075-4418/5/2/272/htm)
Further research evidence of the unfitness of the new CDC SEID criteria to be put into use by doctors, or to be part of new physician education programs, comes from a new Norwegian study of 120 adolescent subjects previously determined to have CFS using the NorCAPITAL group’s criteria.
(Asprusten et al. “Systemic exertion intolerance disease diagnostic criteria applied on an adolescent chronic fatigue syndrome cohort: evaluation of subgroup differences and prognostic utility.” http://bmjpaedsopen.bmj.com/content/2/1/e000233)
These CFS subjects were then additionally evaluated for meeting the SEID criteria. 45 of the CFS subjects were SEID-positive, 69 were SEID-negative, and 6 were unclassifiable because of insufficient data.
The Norwegian research findings indicated that:
“No cardiovascular, infectious, inflammatory, neuroendocrine or cognitive biomarker differed significantly between the SEID-positive and the SEID-negative groups.”
“The SEID-positive group had significantly more depressive symptoms.”
From the study’s Conclusion section:
“This study questions the discriminant and prognostic validity of the SEID diagnostic criteria in adolescent CFS, and suggests that the criteria tend to select patients with depressive symptoms. These results corroborate earlier findings and question the concept of classifying fatigued patients based on symptom phenotype.”
This sample of CFS subjects had been screened for clinical depressive disorders, but depressive symptoms considered secondary were allowed.
These findings suggest that the SEID diagnostic criteria do not discriminate between patients with physical abnormalities detectable by laboratory testing and those patients with subjective symptoms. Also, the SEID criteria are biased towards selecting patients with depressive symptoms.
In practice, doctors will be diagnosing SEID from a general population which has not been screened for clinical depressive disorders. Because the SEID criteria have no exclusions, patients with a primary, i.e., not determined to be subsequent to another disease, undiagnosed clinical depressive disorders will be eligible to be diagnosed with SEID.
In the Jason et al. study cited above, 47% of a group of patients diagnosed with primary melancholic depression (a severe form of clinical depression excluded by the Fukuda CFS definition) met the diagnostic criteria for SEID.
As independent research is now showing, it appears to have been premature and irresponsible of the CDC to begin recommending the unvalidated IOM criteria for the diagnosis of “ME/CFS” (SEID).
Nevertheless, the CDC is now recommending solely the SEID criteria for use in diagnosing “ME/CFS.” The CDC website now has no recommendation for diagnosing CFS.
Also, no provision is made on the CDC ME/CFS website to prevent people with myalgic encephalomyelitis (ME) from being misdiagnosed with SEID. Patients with primary psychiatric disorders also will suffer from being misdiagnosed with SEID because they will be less likely to receive appropriate psychiatric treatment.
ME is a separate disease with its own current diagnostic and research criteria, the ME-ICC, which the IOM report and the CDC are attempting to hide within their new “one-size-fits-all” unvalidated SEID diagnosis. Previously, the CDC on its CFS website, as recently as 2012, had acknowledged that ME is a separate disease with its own case definition:
"The name myalgic encephalomyelitis (ME) was coined in the 1950s to clarify well-documented outbreaks of disease; however, ME is accompanied by neurologic and muscular signs and has a case definition distinct from that of CFS.”
At the very least, the CDC ME/CFS website should acknowledge that the neurological disease ME must be ruled out by doctors using the 2011 ME-ICC and 2012 IC Primer before making an “ME/CFS” (SEID) diagnosis. Since 2015, ME G93.3 has been excluded from the CFS R53.82 diagnosis in the US version of ICD-10. However, few doctors or researchers seem to be aware of this change because the CDC has not publicized it, even though the CDC controls the US version of the ICD.
See ME advocate Gabby Klein’s recent article “Beware of Aiding in the Burial of ME!” for an accurate account of how the CDC and its allies are now using the SEID criteria to hide the separate disease ME within their newly created group of medical and psychiatric disorders called “ME/CFS,” which is actually newly invented SEID.
As Gabby Klein reports, the former CFIDS Association of America (CAA), now renamed the Solve ME/CFS Initiative (SMCI), and the ironically named US group MEAction are now attempting to promote further the SEID misdiagnosis by unnecessarily including the IOM report’s recommendation to use the SEID criteria for diagnosis and physician education in Senate resolution S.Res.508, dated May 15, 2018.
See also my previous Note “The Ambiguous Term ME/CFS: Why ME and CFS Cannot Be Combined” for why the term “ME/CFS” is vulnerable to this type of exploitation by unprincipled organizations using “bait and switch” tactics to further their misguided anti-ME political agendas.
Facebook asks what's on my mind?
It's this two-year-old paper from Leonard Jason's research group at DePaul University in Chicago "Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease."
The paper provides overwhelming research evidence that the CDC's new diagnostic criteria for they are calling "ME/CFS" is unfit for use and dangerously flawed.
This paper and the Jason research group's other papers with similar findings should have been the end of consideration of ever putting the egregiously flawed IOM report recommendations into use.
Knowing how much the IOM criteria over-diagnose what they are calling SEID should have caused HHS to shelve the IOM report as unfit for use and ask for their million dollars back. As Byron Hyde said in 1998:
"Definitions are not diseases, they are often simply the best descriptions that physicians and researchers can offer, with their always imperfect knowledge, to describe a disease. Good definitions are good because they correspond closely to the disease state being described."
The IOM definition of SEID corresponds to absolutely no disease state existing in any coherent group of patients. It is not even close. What disease with a common pathology could possibly be producing the SEID symptoms in patients as diverse as those Jason et al. found to meet the SEID criteria?
"However, the core IOM symptoms are not unique to SEID, as other illnesses have comparable symptoms (eg, cancer, Hashimoto, lupus, chronic heart failure, multiple sclerosis, etc.)."
“For example, 47% of a sample of individuals with melancholic depression met the SEID criteria. Including individuals in treatment studies who have a primary affective disorder but were misdiagnosed with SEID will lead to difficulties in interpreting treatment effects for individuals with ME.”
The four common IOM symptoms could as easily diagnose major depressive order (MDD) as patients previously qualifying for the CDC's CFS diagnosis. People with MDD report fatigue, low energy and malaise after exertion, disturbed sleep, and difficulty concentrating.
The CDC is now knowingly promoting unacceptably flawed diagnostic criteria for a major disease. This is shocking enough. The CDC has a long history of wrongdoing regarding ME and CFS.
What is absolutely appalling is that any professional in the field of ME and CFS should support the systematic misdiagnosis of hundreds of thousand of people in the US alone.
The SEID misdiagnosis will not only harm people with ME, but people with other serious medical and psychiatric disorders who will be swept up into the SEID wastebasket diagnosis and will not receive appropriate medical and psychiatric care, or social support.
Prominent researchers Ian Lipkin and Mady Hornig, along with well-known CFS doctors Lucinda Bateman, Nancy Klimas, Anthony Komaroff, Susan Levine, José Montoya, and Daniel Peterson have all gone on record supporting the SEID misdiagnosis and disingenuously claiming that this is how "ME/CFS" is now diagnosed. What chance do people with ME have when egregiously unsound medicine and science have become the norm in the field?
From the Nagy-Szakal et al. paper:
"Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is an unexplained, chronic debilitating disorder that in the USA alone is estimated to affect up to 2.5 million people, with annual costs of $24 billion [1, 2]."
"Diagnosis is based on the presence of three of the following symptoms:
(1) fatigue impairing an individual’s ability to engage in occupational, educational, social, or personal activities for at least 6 months;
(2) post-exertional malaise and unrefreshing sleep; and
(3) at least one of the following two symptoms: cognitive impairment and orthostatic intolerance ."
Reference  is the 2015 IOM report. The authors of this paper falsely claim that the IOM criteria were used for diagnosing "ME/CFS" even before the CDC put the IOM criteria on its ME/CFS website.
I consider this professional misconduct and deception in a scientific paper by the prominent authors who apparently believe they are above reproach and being held accountable for the accuracy of papers they put their names on. They are probably right.
Ambiguities and Inaccuracies in the 2015 IOM Report Opening Paragraph
JERROLD SPINHIRNE·TUESDAY, JUNE 12, 2018
From 2015 IOM report Summary opening paragraph, page 1:
"Myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS) are serious, debilitating conditions that impose a burden of illness on millions of people in the United States and around the world."
(IOM, Institute of Medicine. 2015. Beyond myalgic encephalomyelitis/chronic fatigue syndrome: Redefining an illness. Washington, DC: The National Academies Press. https://www.nap.edu/read/19012/chapter/2)
Here ME and CFS are separate "conditions," although ME has been listed as G93.3 under "Diseases of the nervous system" in the WHO ICD since 1969. The 2011 ME-ICC also refer to ME as a "disease" throughout.
(Myalgic encephalomyelitis: International Consensus Criteria published in 2011 in the Journal of Internal Medicine
Next from the first paragraph:
Somewhere between 836,000 and 2.5 million Americans are estimated to have these disorders (Jason et al., 1999, 2006b).
The first reference is:
(Jason et al. 1999. A community-based study of chronic fatigue syndrome. Archives of Internal Medicine 159(18):2129-2137.
From the Abstract of Jason et al.:
"Findings indicated that CFS occurs in about 0.42% (95% confidence interval, 0.29%-0.56%) of this random community-based sample."
In 2015, the US population was about 321 million. Therefore, a 0.42% prevalence rate estimates 1.3 million people with CFS. Where did the 2.5 million number come from?
The authors of the IOM report apparently used the number 2.5 million found in the following Jason et al. reference for people with a "CFS-like illness," whatever that might be, instead of CFS. This is very careless of the authors, at least.
Also, it's unclear where the number 836,000 came from. The referenced article states:
"As many as 900,000 Americans have CFS according to the Centers for Disease Control and Prevention (CDC) and research conducted by DePaul University."
(Jason, et al. 2006b. The face of CFS in the U.S. CFIDS Chronicle 16-21. https://www.researchgate.net/profile/Leonard_Jason/publication/236995875_The_Face_of_CFS_in_the_US/links/00b7d51acf6823bccb000000/The-Face-of-CFS-in-the-US.pdf)
The number “836,000” occurs nowhere in the referenced article. Apparently, the IOM report authors thought that 836,000 looked more accurate than 900,000.
Additionally, both references are for Fukuda CFS only, not ME, so saying "these disorders" is misleading.
As for the number of people with ME in the US, the number is unknown because research on ME, unmixed with CFS, is suppressed and not funded by the CDC and NIH.
A 2011 study by Nacul et al. in England found a prevalence of 0.11% for Canadian Consensus Criteria ME/CFS, which is likely to approximate the prevalence of ICC ME.
"The estimated minimum prevalence rate of ME/CFS was 0.2% for cases meeting any of the study case definitions, 0.19% for the CDC-1994 definition, 0.11% for the Canadian definition and 0.03% for the ECD. [Canadian and Epidemiological Case Definitions.]”
(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.
Using a 2018 US population of 327 million and prevalence of 0.11% gives an estimate of 360,000 people with CCC ME/CFS, far lower than the CFS numbers cited by the IOM report. This shows the importance of keeping the two diagnoses separate, and that they cannot be considered to be the same illness. The estimate for the number of people in the US meeting the ME-ICC is probably somewhat lower.
There is really no explanation why the IOM report authors omitted estimates for the number of people in the US with ME except as an attempt to blur the distinction between ME and CFS.
The first paragraph continues:
"The cause of ME/CFS remains unknown, although in many cases, symptoms may have been triggered by an infection or other prodromal event, such as “immunization, anesthetics, physical trauma, exposure to environmental pollutants, chemicals and heavy metals, and rarely blood transfusions” (Carruthers and van de Sande, 2005, p. 1)."
The reference is the 2005 Overview of the CCC which does use the term "ME/CFS," but specifically defined, rather than referring to ME and CFS combined together.
(Carruthers, B. M., and M. I. van de Sande. 2005. Myalgic encephalomyelitis/chronic fatigue syndrome: A clinical case definition and guidelines for medical practitioners: An overview of the Canadian consensus document. Vancouver, BC: Carruthers and van de Sande.
The IOM report authors here omit mentioning possible causes of ME or CFS, again probably to blur the distinction between ME and CFS.
Then the paragraph continues:
"Over a period of decades, clinicians and researchers developed separate case definitions and diagnostic criteria for ME and CFS, although the terms denote conditions with similar symptoms."
Here the IOM report authors are being obviously disingenuous and misleading. Many diseases have "similar symptoms," but that does not in any way imply that different diseases, such as cancer and MS which can have similar symptoms, should be combined. To do so would be absurd and medically dangerous.
Nevertheless, the paragraph continues:
"The literature analysis conducted in support of this study took into consideration the variability in the definitions used in the studies reviewed. For the purposes of this report, the umbrella term “ME/CFS” is used to refer to both conditions."
Here we have the central problem with the entire IOM report. There is absolutely no rational or evidentiary basis for combining ME and CFS under an umbrella term, except that the IOM report authors were ordered to do so by the Department of Health and Human Services (HHS) under the terms of their contract with the IOM.
The Statement of Work, part of the HHS-IOM contract, states:
"For the purposes of this document ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness."
The IOM report's value as an independent scientific inquiry was thus nullified from the start by the unethical and irrational provisions of the agreement between HHS and the Institute of Medicine (IOM, now renamed the National Academy of Medicine). The conclusions and recommendations of the IOM report were. therefore, predetermined to be biased and unreliable by the terms of the original contract.
It is difficult to understand why any professional would agree to serve on an IOM panel that was restricted by contract from separating the neurological disease ME and the ill-defined condition CFS. CFS has always been defined as a diagnosis of exclusion by the CDC. It is completely irrational to combine, under an umbrella term, a WHO-recognized diagnosis, ME, and a diagnosis of exclusion, CFS, which, by CDC definition, excludes any condition with a similar clinical presentation, such as ME.
It now appears obvious from the very first paragraph of the IOM report that the authors had not only agreed to serve under an egregiously biased contract, which by authoritarian fiat forbid the separation of ME and CFS, and, by extension, acknowledgement of the 2011 ME-ICC, which calls for the explicit removal of ME from the diverse illness group CFS.
Also, it is apparent from the very first paragraph of the IOM report, that the authors felt no compunction to represent accurately references or facts, as is customary in scientific papers.
As a result of the IOM panel "just following orders," in obedience to authoritarian bureaucrats at HHS, we now have an unacceptably biased and inaccurate set of diagnostic criteria for the clinical nonentity, “systemic exertion intolerance disease" (SEID). The CDC is now recommending the IOM criteria for the diagnosis of "ME/CFS," which is now actually the ill-defined fatigue and malaise condition SEID, which has never been scientifically validated by independent investigators as a coherent illness grouping, let alone as a disease.
The IOM report in one blow has demolished not only ME and CFS, but also any remaining meaning for the mixed term "ME/CFS." It is now unclear if “ME/CFS” refers the disease diagnosed by the Canadian Consensus Criteria, which is very close to ICC ME, or the meaningless wastebasket diagnosis SEID. IOM “ME/CFS” will soon lose credibility with doctors and the public once they discover how low bar was set for its diagnosis by the IOM report authors.
The failings and deceit of the two-year, one million dollar IOM report should have been a medical and scientific scandal. Instead, the IOM report is being hailed as progress because it makes it easy to diagnose SEID. Just as inflation reduces the value of money, the increased number of diverse patients eligible for the "ME/CFS" (SEID) diagnosis will reduce the value of that diagnosis to almost nothing.
Yes, it's that bad.