We are international medical practitioners and researchers in the field of myalgic encephalomyelitis (ME), ME advocates, patients and their supporters.  We are located in the US and in other countries that are affected by US health policy. We call on the US government health agencies to accurately name, define, fund and represent the distinct biomedical disease ME which has been recognized by the World Health Organization (WHO) since 1969 as a neurological disease with the ICD code G93.3 and has been well-defined by the 2011 International Consensus Criteria (ICC). Since October 2015, the US ICD-10-CM classifies ME with the same neurological code, G93.3, as the WHO ICD. 

We demand the US Department of Health and Human Services (HHS) and all its agencies:

• Adopt ICC for diagnostic purposes
• Adopt ICC for research purposes
• Use ICC on all HHS and all HHS agency websites and all educational materials created by or for HHS and its agencies
• Educate medical practitioners to use the IC Primer for diagnosis
• Disseminate the IC primer to educate medical practitioners on testing and treatment
• Insist that ME researchers use ICC for their research funded by HHS or HHS agencies

The Problem:

ME has appeared in 50+ outbreaks worldwide and was first named and defined by Dr. A. Melvin Ramsay after a massive outbreak in 1955 in the Royal Free Hospital in London.  The disease also appears in the sporadic form and is neurological in nature with immune dysfunction, muscle weakness (including paralysis) and pain as well as affecting multiple body systems.  It renders most afflicted unable to work – many become house or bed bound. Severely affected patients are left isolated, unable to tolerate human interaction and often require 24/7 care for basic needs. Currently, there is no FDA approved treatment or cure.

In an attempt to mystify and marginalize this severely debilitating disease, government health agencies have misrepresented ME as part of an ill-defined chronic fatigue syndrome (CFS) (Reeves’, Fukuda, Oxford).  The latest attempt at obfuscation by the US Department of Health and Human Services (HHS) has been sponsoring and adopting the recommendations by the Institute of Medicine (IOM) (now called the National Academy of Medicine) to use the name Systemic Exertion Intolerance Disease (SEID) and the IOM/SEID criteria.  The IOM/SEID definition does not require any neurological or immune dysfunction symptoms and because of its lack of specificity will include many who do not suffer from ME.

Research by Dr. Leonard Jason’s group at DePaul University, Frank Twisk, and Asprusten et al. has shown that the IOM/SEID criteria do not define the distinct neuroimmune disease ME as described in the medical literature, classified by the WHO and defined by the ICC. Research affirms that unlike the ICC, the four required subjective symptoms of the IOM criteria are commonly found in many chronic diseases and are not unique to any identifiable disease. In addition, the IOM/SEID criteria lack exclusions for conditions with similar symptoms that are typically found in disease definitions.

As a result, the IOM/SEID criteria select a broad, diverse group of people without a common underlying pathology. Research by the DePaul group has found that the IOM criteria increase the prevalence of Fukuda CFS almost three times from 0.42% to 1.2% – or about 4 million people in the US alone. Only a small fraction of that group will be people with ME – an estimated 10 to 20 percent. Many in that broad group will be misdiagnosed with IOM/SEID while they actually suffer from different conditions with some similar symptoms.  The confusion caused by the co-mingling of ME and non-ME patients will result in harm to people with ME (#PwME) through the recommendation of inappropriate treatment – as well as to all of those who don’t have ME but are misdiagnosed. Moreover, the use of the IOM/SEID criteria in research (which is already happening) will impede meaningful scientific progress by selecting patients for ME research who do not have the disease ME.

We, therefore, reject the IOM recommendations and object to their implementation; SEID does not accurately name, and the IOM/SEID criteria do not explicitly define the distinct disease ME.  We further object to the reference by HHS and its agencies in their educational material or otherwise, to the IOM/SEID criteria concerning ME. The government’s malfeasance has already caused too much suffering and premature deaths in over three decades.  We will not stand by in silence while more of this whitewashing and harm take place. The time to act is now!

We demand HHS adopt myalgic encephalomyelitis as classified by WHO and defined by the ICC for diagnostic and research purposes and all education materials created by or for HHS and its agencies now! 

References:

IOM- Report Guide for Physicians

ME-ICC diagnostic and research criteria
    Note: This includes atypical ME which requires fewer symptoms.

IC Primer for Medical Practitioners

Chart comparing IOM/SEID and ICC criteria

ICC Questionnaire “What is it? Do I fit the Criteria?”

Jason et al. June 2015 "Unintended Consequences of not Specifying Exclusionary Illnesses for Systemic Exertion Intolerance Disease."

Jason et al. July 2015 "Reflections on the Institute of Medicine’s systemic exertion intolerance disease.”

Jason L.A. September 2015 “Patients battle for justice.”

Frank N.M.Twisk April 2015 “A critical analysis of the proposal of the Institute of Medicine to replace Myalgic Encephalomyelitis and Chronic Fatigue Syndrome by a new diagnostic entity called Systemic Exertion Intolerance Disease.”

Frank N.M. Twisk February 2016 “Replacing Myalgic Encephalomyelitis and Chronic Fatigue Syndrome with Systemic Exercise Intolerance Disease Is Not the Way forward.”

Asprusten et al. March 2018 “Systemic exertion intolerance disease diagnostic criteria applied on an adolescent chronic fatigue syndrome cohort: evaluation of subgroup differences and prognostic utility.”