ME/CFS-IOM is a clinical criteria

Not a research criteria

The ME/CFS-IOM criteria was created by the Institute of Medicine (IOM), paid for under a U.S. government contract.  It was not created by experts with experience with myalgic encephalomyelitis.  

I was involved in advocacy in 2015 at the time the IOM report was “rolled out” and I followed closely what was said at the time.  For those who were involved at that time, this will cover very familiar ground.  

For those who missed what was happening at that time, the information here may be helpful to understand why there is mistrust of the NIH and CDC.  It may also help expose why many long-time advocates give pushback against “ME” organizations who are promoting the ME/CFS-IOM criteria that is not specific to ME.

If this is old information (or you are not up to reading), I hope you’ll go to the end of the article (Actions To Take) to see the things you can do to help advocate.

We sometimes visit this nearby forest preserve on the way back from getting my weekly IV fluids.  It’s a welcome respite when the weather is nice.

ME/CFS label reused

When the IOM came out in 2015, that criteria was originally labeled systemic exertion intolerance disease (SEID).  The label was not well received by the community so instead the label of ME/CFS was reused and applied to this new criteria.  SEID is still being used in some places. 

The ME/CFS label was attached to the 2003 Canadian Consensus Criteria (CCC) so anything written prior to 2015 is likely referring to the CCC.  After 2015 the ME/CFS label may apply to the IOM definition or the CCC.  At times it is very unclear what someone means when they say “ME/CFS” unless they clarify which criteria it is referencing.

At the time of the ME/CFS-IOM roll out, it was made clear that this criteria was created to cast a wide net to diagnose all those who fell under this “ME/CFS” (ME and CFS) umbrella.  The goal included a very simple description for inexperienced doctors to apply the ‘ME/CFS” label.  It did not offer a clear understanding of the reality of ME as a distinct disease.

From the introduction of the IOM report Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness:

“Throughout this report, the umbrella term “ME/CFS” is used to refer to ME and CFS.” 

This criteria is not specific enough to be used for research for myalgic encephalomyelitis.  In order to create this criteria they removed the elements that did not overlap between ME and CFS.  This resulted in leaving out much of what makes ME unique.  Many of the immunological, cardiac and neurological issues were not included in this new “ME/CFS” definition.

The Comparison Between ICC & IOM chart from MEadvocacy.org shows the differences between these two criteria and makes clear that the International Consensus Criteria (ICC) is a more accurate description of the myalgic encephalomyelitis patient group.

As if all of this isn’t confusing enough, the Institute of Medicine (IOM) was renamed the National Academy of Medicine or NAM.

The CDC website’s description of “ME/CFS” uses the IOM’s definition.  The UK’s NICE guidelines is very similar to the IOM’s definition which underscores that what happens in the US affects people in other countries.

IOM created a new criteria despite protests

The contract to create an “ME/CFS” criteria was done ignoring the recommendations of many stakeholders in the community, including the government’s Chronic Fatigue Syndrome Advisory Committee (CFSAC) whose charge was to provide recommendations to the Secretary of Health and Human Services (HHS).  

The January 2015 Comments from the HHS Chronic Fatigue Syndrome ADVISORY COMMITTEE Subject: Draft Report Pathways to Prevention: Advancing the Research on ME/CFS stated the following on page 14. 

“The CFSAC endorses universal acceptance of the Canadian Consensus Criteria at this time.  A single case definition is needed to conduct reproducible research and appropriate treatment strategies.”

To learn more about the original outcry about the IOM contract, see the following examples of what was written at that time:

• HHS Appalling Actions Against ME and CFS Patients public comment by Eileen Holderman published at MEadvocacy.org.

• Twilight Zone: IOM Committee Nominations Not Even in the Realm of Reasonableness by Jeannette Burmeister (Dec 2013)

• Multiple articles by Jeannette Burmeister (Jan 2013)

• Now You See It, Now You Don’t: HHS Covers Up Flawed IOM Contracting Procedure by Jeannette Burmeister (April 2014)

• Lean in*: the IOM, Wikipedia and a bit more legal by Valerie Eliot Smith (Jan 2014) - includes links to other stakeholders including the following:

  • Jeannette Burmeister 

  • Derek Enlander (delivered by Jay Spero)

  • Mindy Kitei

  • Phoenix Rising (website statement)

  • Mary Schweitzer/Pat Fero

  • Jennifer Spotila 

  • Maryann Spurgin (delivered by Charlotte von Salis)

  • Charlotte von Salis

• The IOM: Death by Acronym and Epic Media Fail by Valerie Eliot Smith (Feb 2015)

• ME Global Chronicle issue #1 (Jan 2014) includes a couple of articles about the IOM report including Stop the HHS-IOM contract and accept the CCC definition of M.E 

• ME Global Chronicle issue #2 (Feb 2015) included several articles about the IOM.  

• Other issues of the ME Global Chronicle have articles about the IOM.  See HERE for index to issues.

A petition labeled, Stop the HHS-IOM contract and accept the CCC definition of M.E. was signed by thousands of people including many experts in the field.  It states in part:

“Now the HHS is attempting to prolong this time by contracting with the Institute of Medicine (IOM) to redefine the illness.  This is unnecessary because experts in the illness, researchers and clinicians alike, have reached a consensus that the Canadian Consensus Criteria (CCC) should be used for both research and clinical purposes.  They have sent an Open Letter to Secretary Sebelius expressing their support for the CCC”

The open letter signed by many who are still active in the ME community can be found HERE.

Some of the signatories include:

• Lucinda Bateman, MD 

• David S. Bell, MD

• Paul R. Cheney, MD

• John K.S. Chia, MD 

• Kenny L. De Meirleir, MD

• Derek Enlander, MD

• Mary Ann Fletcher, PhD 

• Maureen Hanson, PhD 

• Leonard A. Jason, PhD 

• Nancy Klimas, MD 

• A.Martin Lerner, MD

• Susan Levine, MD

• Jose G. Montoya, MD

• Daniel Peterson, MD

• Irma Rey, MD

• Christopher R. Snell

• Staci Stevens, MD

• Sonya Marshall-Gradisnik, PhD

• Rosamund Vallings

Note:  At that time, the CCC was more widely accepted and had been in use for many years.  The International Consensus Criteria (ICC) was only a few years old and it didn’t yet have the wide acceptance needed to reach an agreement.

ME/CFS-IOM is not an ME criteria

While many lump ME, ME/CFS and CFS together as if they are one thing, there are distinct differences between these patient groups.  See here for previous articles discussing the problem with lumping multiple patient groups together:

• Stratifying patients for ME research

• ME/CFS is an umbrella term

• The meaning of CFS depends on who you ask

• Clarity for All (about creation of the US ICD code G93.32)

In July of 2020, Eun-Jin Lim and Chang-Gue Son published a review of case definitions for ME/CFS. 

Their in depth review categorized criteria as being either “ME, ME/CFS” or “CFS, SEID”.

Figure one, seen HERE, lists the ICC and the CCC under ME, ME/CFS.  It lists Fukuda and the IOM criteria under CFS. 

I think this is a reasonable and important distinction.  It is crucial that doctors and researchers stratify patients into groups in order to do proper research and offer best options for treatment.

ME/CFS-IOM Not a Research Criteria

Differentiating between criteria used by doctors (clinical) and criteria used by researchers is one of the most important aspects of the future for ME research.

Many ME community stakeholders have voiced the understanding that the ME/CFS-IOM criteria is meant for clinical use and not for research.

Leonard A Jason et al published a paper in Nov 2015 titled Examining the Institute of Medicine’s Recommendations Regarding Chronic Fatigue Syndrome: Clinical Versus Research Criteria that stated: 

“The Institute of Medicine (2015) has proposed a new clinical case definition for what had been known as chronic fatigue syndrome (CFS). ….  In addition, in August of 2015, the CFS Advisory Committee, which makes recommendations to the Secretary of US Department of Health and Human Services, proposed that the Canadian 2003 criteria should serve as the research case for CFS.”

I came across an article that helped me have more clarity about the difference between criteria meant for diagnosis and criteria meant for research.  Distinctions Between Diagnostic and Classification Criteria? states the following:

“Diagnostic criteria are generally broad and must reflect the different features of a disease (heterogeneity), with a view to accurately identify as many people with the condition as possible.”

“Classification criteria are standardized definitions that are primarily intended to create well-defined, relatively homogenous cohorts for clinical research; they are not intended to capture the entire universe of possible patients, but rather to capture the majority of patients with key shared features of the condition. Hence the goal of classification differs from the intent of diagnostic criteria.”

The CDC refers to the IOM as a diagnostic criteria (not for research).  See HERE. 

Educating AI

I have been asking Facebook’s AI various questions about myalgic encephalomyelitis and have been appalled at the terrible misinformation offered.  During each of these exchanges with this AI, I have replied with corrected information (with citations) and the AI has apologized and said they will correct their information. 

Unfortunately, I am aware that others have asked similar questions and have also received inaccurate harmful replies that need to be corrected.  We need more people to educate AI!

The following exchange between myself and Facebook’s AI is a good example:

I asked Facebook's AI if the IOM criteria for ME/CFS is a research criteria and to cite sources. 

The following was the answer (that was incorrect): 

“Yes, the Institute of Medicine (IOM) criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) are considered research criteria.

The IOM report, "Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness" (2015), states that the criteria are intended for both clinical and research purposes. [1]

The IOM criteria are widely used in research studies to define ME/CFS and identify participants for studies.  For example, a 2021 systematic review of ME/CFS treatments used the IOM criteria to select studies for inclusion. [2]

However, it's important to note that some researchers and clinicians have raised concerns about the IOM criteria, suggesting that they may be too broad and may not accurately capture the complexities of ME/CFS. [3]

References:

[1] Institute of Medicine. (2015). Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. National Academies Press.

[2] Castellazzi, M., et al. (2021). Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review of Therapeutic Interventions. Journal of Clinical Medicine, 10(11), 2421.

[3] Jason, L. A., et al. (2017). Unintended Consequences of the IOM Criteria for ME/CFS. Diagnosis, 4(2), 139-143.

Let me know if you have any further questions!”

My reply to that was:

“There is an error in your answer.  The citation from Jason states: "Even though the SEID criteria are for a clinical case definition [1], rather than a research case definition.  That indicates this is not a research criteria.”

The AI replied with this apology:

“I apologize for the mistake. You are correct that the SEID criteria are for a clinical case definition, not a research case definition. Thank you for pointing out the error.  I will make sure to correct my understanding and provide more accurate information in the future.  If you have any further questions or need clarification, please feel free to ask!”

I thanked the AI who replied with:

“You're welcome!  It's important to ensure the accuracy of information, and I appreciate your diligence in correcting me.  If you have any other questions or need assistance with anything else, please don't hesitate to ask!  Have a great day!”

Several days later I followed up with the following question:

“You previously stated "The IOM report, "Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness" (2015), states that the criteria are intended for both clinical and research purposes. [1]" Can you tell me what page that is stated?”

AI replied with another apology:

“I apologize for my previous mistake.  The IOM report "Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome:  Redefining an Illness" (2015) does not explicitly state that the criteria are intended for both clinical and research purposes.  The report presents the criteria as a clinical case definition, and it does not explicitly address research purposes.  Thank you for bringing this to my attention.”

I would be very interested to hear what AI is saying to others about whether the ME/CFS-IOM is a research criteria.

Actions to take

1. Sign the #PwME4ICC Demand US Health Agencies Recognize Myalgic Encephalomyelitis as Defined by ICC asking HHS to adopt the ICC for research.

2. Donate to researchers who use the ICC (or CCC) and not to those researchers wasting money using the IOM/NAM criteria

3. Donate to non-profit charities who explain that the IOM criteria is not an ME criteria and that anyone given that diagnosis should be further screened for ME

4. Educate AI platforms about the following

   1. ME is a distinct disease diagnosed using the ICC

   2. Graded exercise therapy is NOT safe to treat ME

   3. The ME/CFS-IOM criteria is NOT a research criteria

   4. The ICC is the most current ME criteria for clinical care and research

Together we can make a difference.

Colleen

Information provided here or in comments is not to be considered medical advice

Sources:

Lim EJ, Son CG. Review of case definitions for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). J Transl Med. 2020 Jul 29;18(1):289. doi: 10.1186/s12967-020-02455-0. PMID: 32727489; PMCID: PMC7391812.

Jason LA, McManimen S, Sunnquist M, Brown A, Newton JL, Strand EB. Examining the Institute of Medicine's Recommendations Regarding Chronic Fatigue Syndrome: Clinical Versus Research Criteria. J Neurol Psychol. 2015;2015(Suppl 2):http://www.avensonline.org/wp-content/uploads/JNP-2332-3469-S2-0002.pdf. Epub 2015 Nov 25. PMID: 27595126; PMCID: PMC5008852.