This blog was written in collaboration with Gabby Klein
The Centers for Disease Control and Prevention (CDC) updated their website for ‘ME/CFS’ on July 3, 2017. The revision was based on information provided by a stakeholders' working group and was decided upon by a steering committee of government people. The changes were based on the 2015 IOM Report which was sponsored and guided by the Health and Human Services (HHS). MEadvocacy.org and ME advocates continue to advocate for criteria created by ME experts such as the International Consensus Criteria (ICC) and warn the community against the dangers of CDC's blanket adoption of the overly broad and untested IOM criteria. Additionally, upon review of the revised website, we have uncovered many other weaknesses which are listed below.
MEadvocacy was aware of the risks in using the new IOM criteria, which are just another government production of a vague fatigue definition. We, therefore, opted out of Dr. Unger 's invitation in January 2016 to participate in their Technical Development Workgroup (TDW) to provide input for the upgrading of CDC's website and provide information for their medical educational materials. In our communications with Dr. Unger, it was made clear that only material from the IOM report would be considered in this update. MEadvocacy told Dr. Unger we would only participate if material from the Canadian Consensus Criteria (CCC) and ICC would be used.
Problems With the IOM Criteria
The IOM committee clarified in their 2015 report that the disease they were defining was not the neuroimmune disease myalgic encephalomyelitis (ME) but, another “disorder”. They wrote: “.. and that the name “myalgic encephalomyelitis” does not accurately describe the major features of the disease. In their place, the committee proposes “systemic exertion intolerance disease” as a name that better captures the full scope of this disorder.”
Additionally, Dr. Leonard Jason's - "Patients Battle for Justice" found that the IOM diagnosis, in reality, is not any particular disease, let alone ME. Dr. Jason stated: “The IOM also released a new case definition to replace CFS, and our published work now suggests that these new criteria would almost triple the prior CFS prevalence rate, and this is in part due to the inclusion of individuals who formerly had been excluded. Unwittingly, this inadvertent action accomplished much of what Bill Reeves and the CDC had attempted to do a decade ago when they proposed an ill-fated expansion of the case definition.”
In this paper, Frank Twisk demonstrates the shortcomings of the SEID (IOM) criteria. Frank explains the problem with the parameters of the literature the IOM panel was charged to review by HHS. It was mostly based on studies using CFS criteria. It is not surprising then that their result is a definition of CFS - not ME. Additionally, like the previous CDC criteria, the IOM definition is based on the vague, subjective symptom of "fatigue."
Frank states that this new definition will include many who do not suffer from ME: He wrote: "Patients with any of the following conditions will all meet the criteria for a diagnosis of SEID: postural orthostatic tachycardia syndrome, chronic heart failure, chronic obstructive pulmonary disease, mitochondrial diseases, Addison's disease, fibromyalgia, and depression."
The IOM criteria do not demand any immune symptoms in their core symptoms list and only cite one neurological symptom as a choice of 2. How can you define a neuroimmune disease with no symptoms of neurological or immunological dysregulation? Because there are no exclusions listed, many people suffering from medical or psychiatric diseases with similar symptoms will be diagnosed with the disease. There are no recommendations for specific testing to confirm a diagnosis. It might be true that we presently do not have one specific biomarker for diagnosing ME (2-day CPET testing is not feasible for many patients), but there are tests which in tandem with identified symptoms can help confirm a firm diagnosis (see a list of tests below).
Many Weaknesses with the CDC Website Revision
Laundering CDC information through the IOM: Epidemiology figures, data about % diagnosed and data about economic burdens are all CDC data yet CDC attributes them to the IOM report. The IOM report is based on a literature review of existing data and studies (of which most ME research based on the CCC and ICC were excluded). The IOM panel did not do any of their own investigations, and the figures listed on the CDC website are original CDC data.
Whitewashing the severity of the disease: The website states - “People with ME/CFS are not able to function the same way they did before they became ill.” In actuality, more than half the patients are unable to work at all, and 25% are bedbound. They make it sound like it’s just a mild annoyance!
Deflecting responsibility for medical negligence: They blame problems with diagnosis and inadequate medical care on several factors like the lack of medical education yet do not admit that it has been their decades-long disrespect, injustice, and malfeasance which have adversely impacted progress with this disease.
Ignoring current medical scientific studies: The CDC falsely state that there are no laboratory tests, yet the ICC lists many. Here are some of them:
NK cell function test (low)
Cytokine Panel (distinct increased inflammatory cytokines)
Elevated oxidative stress markers (worsened by exertion),
2-day CPET (abnormalities - worsening on the second day)
Pathogens (abnormalities in EBV, CMV, hhv6, enterovirus, chlamydia pneumonia, parvovirus b19, mycoplasma, Borrelia, 37 kDa 2-5A RNase L immunoassay)
Spect scan with contrast (lowered cortical/cerebellar blood flow)
Intestinal bacteria (increased d-lactic acid)
Tilt table test (to confirm OI)
ATP profile (lowered ATP production)
QEEG (abnormalities in left frontal region, elevated theta and beta frequencies)
No recommendations for differential diagnostic tests: Such as the ones recommended in the ICC:
Infectious disorders: TB, AIDS, Lyme, chronic hepatitis, endocrine gland infections
Neurological disorders: MS, myasthenia gravis, B12;
Autoimmune disorders: polymyositis & polymyalgia rheumatica, rheumatoid arthritis
Endocrine disorders: Addison’s, hypo & hyperthyroidism, Cushing’s Syndrome; cancers
Anemias: iron deficiency, B12 [megaloblastic]; diabetes mellitus; poisons.
Misrepresenting symptom of PEM: CDC does not mention an important feature of PEM - a delayed reaction. The ICC describes PENE (post-exertional neuroimmune exhaustion): a pathological, low threshold of fatigability • post-exertional exhaustion & symptom flare - immediate or delayed, & not relieved by rest • prolonged recovery period. The ICC goes further and explains - Fatigue and pain are part of the body’s global protection response and are indispensable bio alarms that alert patients to modify their activities to prevent further damage.
Oversimplifying the definition of a complex disease: HHS’ charge to the IOM committee in creating another government-sponsored definition was to come up with simple criteria that any medical professional can use to diagnose patients. ME is a multi-system complex disease - similar to lupus in its complexity. The resulting IOM definition with its simple checklist of 3 core symptoms and 1 more of 2 choices, fails in distinguishing ME patients from other psychological and physical diseases. (as shown above)
Recommending yoga and tai chi: The CDC cites yoga and tai chi among complementary therapies. These movement therapies should not be recommended for ME patients. They might be relaxing for healthy people but, for ME patients who suffer from OI, POTS, and vertigo - these movements can be too rough and may induce a crash. Most patients with ME have difficulty standing and/or lifting their arms up. A quarter of ME patients can’t even get out of bed! On which scientific studies is the CDC relying on upon making these recommendations?
Refusing to recommend resting: Dr. Melvin Ramsay, in his publication, ”Myalgic Encephalomyelitis: A Baffling Syndrome With a Tragic Aftermath”, wrote: “those patients who are given a period of enforced rest from the onset have the best prognosis.” ME patient experiences and accounts have confirmed that rest and pacing are the best way to avoid crashing and to prevent possible permanent harm.
Being vague about the injury caused by activity: "ME/CFS may get worse after people with the illness try to do as much as they want or need to do.” As ME patients know very well, it is not a matter of “may” - it is a certainty!
Omitting qualification of core symptoms: the CDC website does not qualify the intensity and frequency demanded in the core symptoms for diagnosis. These symptoms, if only experienced occasionally and mildly, are common.
Linking to harmful treatments: The information to Healthcare Providers sections includes a link to The Alberta, Canada Guidelines which recommend graded exercise therapy (GET) and CBT* as a treatment. [*Edit 4:30 pm est 12/28/17 "and CBT"]
Dangerous Information Provided Through Links
CDC took over a year to work on revising the website with the help of a stakeholders’ working group and a steering committee. It is therefore alarming to see that it contains links to dangerous and outdated information.
The CDC website resources provide a link to NIH Director’s Blog: Moving Toward Answers in ME/CFS, March 2017. Dr. Collins blog links to Medline where the following information about ME/CFS is posted for medical professionals.
Study recommending exercise, stating the following: “Patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes.”
Study recommending CBT: “CBT is effective in reducing fatigue severity in QFS patients” (qfs = cfs patients with q fever).
Study recommending live CBT as opposed to via telephone. The authors state: “However, only the live format was associated with physical symptom improvements, with specific effects on post-exertional malaise, chills, fever, and restful sleep.”
Study on Fear of Movement and Avoidance: “The review revealed that fear of movement and avoidance behavior toward physical activity is highly prevalent in both CFS and FM population, and is related to various clinical characteristics of CFS and FM, including symptom severity and self-reported quality of life and disability. “
The Medline children’s section links to Chronic Fatigue Syndrome (For Parents) (Nemours Foundation). They recommend “regular, carefully planned exercise, which helps by providing healing movement, increased energy, and feelings of well-being” and “..studies have found that individuals with the best chance for improvement are those who remain as active as possible..”
Some Strengths with Revision
Warning about antidepressants: The CDC listened to stakeholders’ input and added a warning about the adverse effects of the use of antidepressants in patients. They write: “However, doctors should use caution in prescribing these medications. Some drugs used to treat depression have other effects that might worsen other ME/CFS symptoms and cause side effects.”
Removing recommendation for GET: The CDC finally, after decades of recommending the harmful graded exercise therapy as a treatment, have silently removed it from their main website, but it remains as a listed treatment in the links to the physician materials. They did not make a public comment about the dangers of “exercise” or “pushing through” or “increasing activities” for 'ME/CFS' patients. They removed GET from the main website but, as cited above, many links to recommendations to exercise still remain. Also, what is really needed is a warning, as they have done with antidepressants, that exercise may be harmful to patients. Not only will it cause crashing but in some cases, it may cause long term impairment.
Removing recommendation for CBT: The CDC replaced cognitive behavior therapy, which could mean therapy that tells patients to ignore their illness and limitations -with the sensible: “Talking with a therapist to help find strategies to cope with the illness and its impact on daily life and relationships.”
The CDC website revision has incorporated the untested IOM/SEID criteria which are not ME criteria. Many other issues remain on the website which we outlined above; therefore, we strongly disagree with other advocates in the community who have called the changes to the CDC website as progress for people with ME. It is just more of the same deceptive tactics that have plagued the field for the last 30 years. The new CDC website is not about ME, but rather about a redefined, less accurate version of CFS that the CDC is now calling "ME/CFS."
Myalgic Encephalomyelitis International Consensus Criteria (ICC) - http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
International Consensus Primer for Medical Practitioners (ICC primer) - http://sacfs.asn.au/download/me_international_consensus_primer_for_medical_practitioners.pdf
Questionnaire for ICC diagnosis - http://www.meadvocacy.org/the_international_consensus_criteria_what_is_it_do_i_fit_the_criteria
Analysis of IOM criteria + CFSAC recommendations and comparison to CCC-