MEadvocacy.org was formed last year with the purpose of promoting and supporting advocacy efforts for the disease Myalgic Encephalomyelitis (ME). At its inception, organizational goals and certain campaigns were outlined, chosen and adopted.
Challenging the three government redefinition projects for "ME/CFS": the Institute of Medicine (IOM) report, the Pathways 2 Prevention (P2P) report and the Center for Disease Control (CDC) Multisite Study.
Getting Myalgic Encephalomyelitis (ME) officially recognized by the US government as its own disease. ME has a 60-year history and has been classified as a neurological disease in the World Health Organization's International Classification of Diseases since 1969.
Getting a single, clear definition for diagnosis and research, which includes the hallmark symptom of post-exertional relapse, adopted as the official definition for ME. An example is the Canadian Consensus Criteria (CCC) or the International Consensus Criteria (ICC) which have been authored by a majority of our ME experts, clinicians, and researchers. ME experts must be used in decision-making as the current “CFS” literature provides a misleading picture of the disease.
Getting government funding to study this devastating disease, similar to the amounts being spent on diseases such as Multiple Sclerosis, Autism, Lupus, Crohn’s Disease, Inflammatory Bowel Disease, Parkinson’s Disease and Alzheimer’s Disease.
MEadvocacy.org was set up in support of the name Myalgic Encephalomyelitis (ME) and the use of the expert authored CCC or ICC.
MEadvocacy.org challenged the U.S. government-sponsored IOM, P2P and the CDC multi-site processes. We opposed the spending of one million dollars of our tax-paying money in a process to redefine, rename and rebrand the disease when good criteria created by international experts and a historical name already existed. We opposed the lack of government transparency as well as the poor stakeholders’ participation in these processes.
In January of 2015, thanks to the community’s support of a successful funding campaign, MEadvocacy.org successfully hired the P.R. firm Crowds on Demand. The P.R. firm has been busy initiating various projects such as arranging for radio interviews, facilitating media contacts, and providing representation at the Congressional Inauguration.
The P.R. firm had a spokesperson speak on our behalf and deliver questions at the IOM Meeting on February 10th, 2015.
The IOM Report
The IOM report was “rolled out” on February 10th and was followed by a deluge of media coverage organized by the IOM. The report was made available in advance to Health and Human Services (HHS) and members of the media. ME stakeholders, clinicians, researchers, patients and advocates were kept in the dark until the official reveal.
The advocates who advise MEadvocacy.org reviewed the IOM report, the diagnostic criteria and the new name, Systemic Exertion Intolerance Disease (SEID). We compared the results with our stated mission and came to the conclusion that the criteria and name did not meet up with our original goals.
The IOM criteria are overly broad and lack essential exclusions.
The lack of exclusions will result in the inclusion of active (untreated) psychiatric-induced fatigue or other fatigue conditions.
The criteria are too simplistic to properly capture the scope of ME, which is a complex, multi-system disease.
The stress on fatigue, as the first/main symptom of the disease, gives the wrong connotation that it is just a “fatiguing” illness.
The symptoms overlap too much with the clinical definition of depression.
The omission of crucial symptoms that fit the core of the ME definitions such as immune impairments, neurological abnormalities and myalgia will result in misdiagnosis.
The lack of recommendation for laboratory testing, such as blood tests to check for viral loads and Natural Killer (NK) cell functions, which will impede possible treatment options.
Fatigue and Pain
We found inadequacies in the core criteria. For example, pain was left out because myalgia, headaches and pain are not unique to SEID since they are found in many other chronic diseases. However, fatigue was chosen as the primary symptom, although it is a common symptom in many acute and chronic illnesses. Placing fatigue in the top line of the “diagnostic algorithm” puts fatigue back as the primary focus.
The inclusion of post-exertional malaise (PEM) as a mandatory symptom is important and very welcome. The recommended two day CPET exercise test can be useful for demonstrating an abnormal response to exertion in patients but it also can be dangerous to some patients. Therefore making this untenable as a biomarker.
Research has shown that ME is a neuro-immune disease. There are definitive findings of neurological and immune dysfunction. It is highly disturbing that symptoms of neurological impairment do not appear as a core symptom.
Immune Dysfunction and Orthostatic Intolerance
The panel found some immune dysfunctions such as NK cell cytotoxicity. Nevertheless, they decided that it was not specific to SEID, and excluded it from the criteria. Yet, they included Orthostatic Intolerance (O.I.) as a choice of symptoms even though it is clearly not specific to SEID. O.I. appears in many diseases such as Parkinson’s, Addison’s, diabetes and more.
Testing and Treatments
The report fails to list tests that many specialists currently find valuable, such as Viral panels and NK Cell Function values. This omission may cause insurers to refuse to cover such tests, saying they are unnecessary. Experts use these tests to help determine if treatments like antivirals and immune modulators might help specific patients. The omission of the recommendation to administer these tests and possible treatments is a consequential one.
MEadvocacy.org stated from the start that we believe the name Myalgic Encephalomyelitis, as coined by Dr. A. Melvin Ramsay, is the name that we adopt. In addition, SEID does not properly convey the seriousness of the disease.
To define the disease by one of its symptoms does not convey the true complexity and severity of the disease.
Exertion intolerance may be interpreted by physicians as a psychosomatic manifestation of "fear avoidance" of exercise.
“Exertion” provides the wrong connotation. For example, if we would only stay within our energy envelope, we would be healthy. Unfamiliar doctors may equate exertion with sweat-producing levels of aerobic exercise, when “exertion” can simply be brushing your teeth.
One of the failures of the IOM report has been that it did not clarify the key question, which disease is SEID replacing? Mary Dimmock wrote a guest blog on Jennie Spotila’s site in November 2013, titled “Which Disease is HHS Studying?” In her blog, Mary communicated the reply that she received from HHS to her question:
"Both Dr. Lee and Ms. Meck said that the scope of disease to be covered by the new clinical criteria has not been specifically defined at this point and that this will need to be defined as the process goes forward.
Dr. Lee indicated that the panel itself would need to resolve this issue and that possible outcomes could be ME as a subgroup of the broader CFS, ME as part of a spectrum that includes these other conditions, or ME as a separately defined disease. Ms. Meck indicated that HHS would be asked to clarify what scope of disease was intended at the first meeting. I raised the concern with Ms. Meck that the scope of disease directly affects panel selection and evidence base selection, but she felt that the panel and process would be able to adjust as needed."
The IOM report did not tackle this crucial question and did not provide a clear answer as to which disease they are replacing. In addition, Dr. Lucinda Bateman, in her comment on the IOM report for the ME Global Chronicle, stated, “I don't recall anything in the IOM report that states the term Myalgic Encephalomyelitis, or ME, cannot be used to describe someone who meets published ME criteria. The recommendation is stop using ME/CFS.”
MEadvocacy.org is interpreting Dr. Bateman’s statement to mean that ME criteria could be used along with the name Myalgic Encephalomyelitis (ME) as officially recognized under the ICD-10-CM code G93.3.
The following are failures of the IOM report, some due to the charge by HHS to the IOM for the study on ME/CFS.
HHS charged the IOM panel to produce “simple” criteria that any GP or nurse can easily use. This resulted in overbroad criteria. Such simplified criteria have not been used for other complex diseases.
The use of evidence-based medicine (EBM) was not appropriate for this complex disease due to the gap in proper large scale studies directly caused by the lack of appropriate levels of research funding.
It did not recommend a specialty which can best care for patients suffering from this complex disease.
There are no recommendations for clinical tests to discriminate differential diagnoses.
HHS did not charge the panel to recommend treatments. This leaves a void in care for patients.
The IOM report did not provide for time to field-test the new criteria before adoption.
Unpublished preliminary results from the ongoing CDC multi-site study was included yet other current research was prohibited. For example, even the Lipkin/Hornig study was not considered even though Drs. Klimas and Bateman were authors of that study as well as IOM panel members.
Research criteria were not part of the scope for the IOM or P2P studies. This might inappropriately result in the use of the IOM criteria for research as well, even though that was not the intent of the IOM panel members when creating the IOM diagnostic criteria.
This was a US government sponsored study. Historically, it is an independent expert medical group who sets criteria for disease, not the government.
There is no data about insurance coverage. It remains unknown whether insurance will cover any visits with specialists for this disease. There is no provision for insurance coverage for specialty tests such as viral titers and NK cell function.
The current coverage for Social Security disability (SSDI) is based on the Fukuda criteria. The medical evidence currently required for SSDI does not match with the IOM criteria. The IOM report does not provide recommendation for newly diagnosed patients with SEID and/or currently enrolled patients receiving SSDI as to qualifications for disability coverage.
The IOM report recommends clinicians to treat the disease symptomatically, yet, there is no recommendation for the most obvious treatment: rest!
There is no recommendation for a warning against CBT/GET.
There was no mention or special section regarding the severely affected patients.
For the reasons outlined above, MEadvocacy.org came to the conclusion that we cannot recommend the IOM criteria or the SEID name. After much consideration, we decided that the plan for MEadvocacy.org going forward is to stay the course with the original goals, retaining the name Myalgic Encephalomyelitis (M.E.) as per 2015 ICD-10CM diagnostic code 93.3, and continuing to support ME criteria such as CCC or ICC which have been authored by a majority of our M.E. experts, clinicians and researchers.
Additionally, MEadvocacy.org will continue with its commitment to advocate for awareness of the severe ME patients, as well as for the promotion of research into these patients. We will focus on campaigning for funding for research commensurate with other severe chronic illnesses like M.S. and Parkinson’s.
Since the unveiling of the IOM report, the community has had highly diverse opinions of the result. Some were vocal with their approval and welcomed the changes that were recommended. Some agreed with most of the report but felt that it would need some changes before it was something that they could endorse. Some rejected this as a flawed government-controlled redefinition and rebranding effort.
This split in the community has caused a lot of contention and confusion. Some initial supporters of MEadvocacy.org expected MEadvocacy.org to change its position due to their own perception of a better-than-expected report. Others have expressed their support with MEadvocacy.org's position and want them to continue with their stated view. All factions are looking at this with their own thoughts and expectations, each believing that their view is more sensible and will better serve the community.
We regret if there was a misunderstanding of what MEadvocacy.org represents. Our hope in writing this article is to clarify our stand, one which has not wavered since the start. We are confident that many in the community share our thoughts and goals.