My original letter of 6/25:
June 25, 2017
To Mayo Clinic:
Re: Myalgic Encephalomeylitis/Chronic Fatigue Syndrome (ME/CFS)
This letter is rather lengthy and contains several hyperlinks; if you would care to receive it in e-mail format which would be much simpler to navigate, please let me know and I’ll be happy to do so. My e-mail address is _______
I am deeply concerned by your clinic’s apparent ignorance of the Institute of Medicine of the National Academies’ report dated February 2015,
Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness, which, among other things, provides guidelines concerning the nature, diagnosis and treatment of ME/CFS which you can find here:
http://www.nationalacademies.org/hmd/~/media/Files/Report Files/2015/MECFS/MECFS_ReportBrief.pdf
http://www.nationalacademies.org/hmd/Reports/2015/ME-CFS.aspx
Two of your recommended treatments as shown on your website for persons with ME/CFS (graded exercise therapy [GET] and counseling [CBT]) are either inappropriate and actually harmful (GET) or just useless (CBT) as explained below. Your website is also misleading as to the intended function of pacing, and the true nature of ME/CFS.
MAYO CLINIC WEBSITE
"Although CFS/ME and SEID share the same major symptom of chronic fatigue, there is variation between the definitions of
these disorders."
This one sentence from your website has two glaring inaccuracies. First, the hallmark of ME/CFS is not chronic fatigue (despite the unfortunate name); rather, it is post-exertional malaise, a pathological response to exertion not found in any other illness.
Second, SEID and ME/CFS are
one and the same illness and your reference to "these disorders" obscures this fact. SEID is the new name for ME/CFS proposed in the IOM report referenced above. New diagnostic criteria were proposed, along with the new name, to more accurately characterize this illness. This raises the question of why the Mayo Clinic wants to make a distinction between SEID and ME/CFS.
You tellingly fail to mention that the new name of Systemic Exertion Intolerance Disease was necessitated by the extremely inaccurate name of Chronic Disease Syndrome, which has led to trivialization of this devastating illness and consequent almost complete absence of research and funding for the last 35 years, leaving patients to languish for decades.
I’m not splitting hairs here. The IOM report states:
"This name [SEID] captures a
central characteristic of the disease - the fact that
exertion of any sort (physical, cognitive or emotional) - can adversely affect patients in multiple organ systems."
This is what the IOM report says as to the diagnosis of SEID/ME/CFS (note that the IOM conflates the two names:
"Diagnostic Criteria for ME/CFS (SEID)
"Diagnosis requires that the patient have the following three symptoms:
(1) A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest, and
(2) Post-exertional malaise,* and
(3) Unrefreshing sleep*
At least one of the two following manifestations is also required:
Cognitive impairment* or
Orthostatic intolerance
The IOM report further states:
"This disease is characterized by profound fatigue, cognitive dysfunction, sleep abnormalities, autonomic manifestations, pain, and other symptoms
that are made worse by exertion of any sort.
" . . . .
"Impaired day-to-day function, post-exertional malaise
(the worsening of symptoms after physical, cognitive, or emotional activity), and unrefreshing sleep are almost universally present in ME/ CFS patients. Therefore, the committee considers these to be the three core symptoms of the disease."
This may seem like quibbling over a definition, but the dangers of using the incorrect diagnostic criteria cannot be overstated. If doctors (including the Mayo Clinic) persist in the idea that ME/CFS is simply a matter of severe fatigue, and are unaware that exertion exacerbates symptoms for persons with ME/CFS, often severely, then they will prescribe GET (graded exercise therapy) as recommended on your website - the single most damaging therapy that can be used with ME/CFS patients.
This is why getting the definition right is crucial. If you have someone who is simply tired because they are deconditioned or depressed, then exertion will not make them worse and they will benefit from GET.
But the central problem of people with ME/CFS is not depression or deconditioning due to lack of exercise; they are unable to exercise because of a failure of energy metabolism, and requiring a person to exercise despite this failure can cause severe harm. This is the major reason why the IOM recommends changing the name from Chronic Fatigue Syndrome to Systemic Exertion Intolerance Disease - it’s not just a cosmetic change.
So that you might understand this inability to tolerate exertion better, I urge you to familiarize yourselves with the results of the 2-day CPET (Cardiopulmonary Exercise Testing) and persons with ME/CFS:
https://www.ncbi.nlm.nih.gov/pubmed/24755065
The second day CPET results for persons with ME/CFS are devastating and not seen in any other illness and are not the result of deconditioing. They are the reason for the term "
post-exertional malaise" (PEM) which is generally delayed onset and most often hits 24 or more hours post-exertion. Some patients were on the verge of heart failure on the second day of testing, unlike the first. No other illness or condition has this feature, including deconditioning.
MAYO WEBSITE:
"The
symptom of chronic fatigue also may arise from more than one underlying condition . . . ."
This is misleading and can lead to inappropriate and harmful treatment. Again, the core problem as identified by the name SEID is the pathological response to exertion experienced by someone with ME/CFS. If someone is tired (due to any sort of condition) but they do not experience post-exertional malaise (PEM) as demonstrated by the 2-day CPET test referenced above, then by definition they do not have ME/CFS. If they have different underlying conditions and do not have PEM, they do not have ME/CFS. It is as though you are conflating all fatiguing illnesses (e.g., hypothyroidism and anemia) into a meaningless hash.
MAYO WEBSITE:
"The immune systems of people who have chronic fatigue syndrome appear to be impaired slightly, but it's unclear if this impairment is enough to actually cause the disorder."
And this is what the IOM states about the immune systems of persons with ME/CFS:
"Sufficient evidence supports the finding of immune dysfunction in ME/CFS (SEID). Specifically, the committee’s literature search yielded data demonstrating poor NK cell cytotoxicity (NK cell function, not number) that correlates with illness severity in ME/CFS (SEID) patients and could serve as a biomarker for the severity of the disease, although it is not specific to ME/CFS (SEID)."
Many do consider low NK cell function to be a biomarker for ME/CFS because it is considered to be universally present in ME/CFS patients. It would be much more accurate and informative for your website to provide this information instead of talking about slight impairment.
MAYO WEBSITE
"Chronic fatigue accompanies
many medical conditions and may not be an isolated symptom. In such cases, the better term may be "chronic multifactorial fatigue."
What does this have to do with ME/CFS? Are you trying to rename ME/CFS? Yes, if one has "chronic fatigue" but does not have ME/CFS, then yes of course they could have "multifactorial fatigue" (whatever that means!) But this section of your website is about ME/CFS, not about any condition which has "chronic fatigue". Unfortunately, you seem to be saying that people with ME/CFS simply have "chronic fatigue". And this is the heart of the matter.
Lastly, but certainly not least, is your section labeled "Therapy". Nowhere in the IOM guidelines do they talk about any of your "therapies". Again, your website is rife with inaccuracy:
MAYO WEBSITE
"Previous studies suggest that graded exercise is an effective and safe treatment ... "
Nowhere is this suggested in the IOM guidelines. It’s actually potentially quite dangerous for persons with ME/CFS for the reasons outlined above. However, this IS one of the main two treatments recommended by the fatally flawed study published in March 5, 2011 in the Lancet:
Comparison of adaptive pacing therapy ("PACE"): cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome. (
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract)
One of the many defects in the PACE study was to actually
lower the recovery threshold from entry levels - in other words, a person could be worse off
after the trial than at the start, and still be considered "recovered". This study has been thoroughly debunked and demands for retraction have been made by leading ME/CFS physicians and researchers worldwide.
See:
TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study
21 October 2015, David Tuller, DrPH,
http://www.virology.ws/2015/10/21/trial-by-error-i/
An open letter to Psychological Medicine about "recovery" and the PACE trial
13 March 2017, signed by over 70 leading ME/CFS specialists (
http://www.virology.ws/2017/03/13/a...l-medicine-about-recovery-and-the-pace-trial/)
PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome –true or false? It’s time for an independent review of the methodology and results
By Charles Bernard Shepherd, published April 9, 2017 (
http://journals.sagepub.com/doi/full/10.1177/1359105317703786
Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial by
Carolyn Wilshire, Tom Kindlon, Alem Matthees & Simon McGrath, published December 14, 2016 (
http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1259724)
MAYO CLINIC WEBSITE:
"Your strength and endurance will improve as you gradually increase the intensity of your exercise over time."
Again, not true for persons with ME/CFS; however, it IS true for persons who are simply deconditioned and do not have ME/CFS.
MAYO CLINIC WEBSITE:
"People who have a better chance of treatment success tend to have less impairment, focus less on symptoms, comply with counseling programs and pace themselves to avoid overexertion and underexertion."
Again, the IOM report says nothing about focusing less on symptoms and complying with counseling programs as a means to recovery. And pacing has nothing to do with underexertion - the sole goal of pacing is to avoid damage and severe exacerbation of symptoms due to
overexertion. No one with ME/CFS has gotten worse from resting, but many have declined, often severely, due to overexertion. The subtext of your statement is that people with ME/CFS are simply deconditioned. You guys just don’t get it, to the severe detriment of patients worldwide, owing to the prestige of the Mayo Clinic.
I urge you to watch former Harvard student Jennifer Brea’s TED talk concerning her experience with ME/CFS and the harm she suffered when she pushed herself physically because of her doctor’s ignorance, in line with your recommendations:
https://www.ted.com/talks/jen_brea_what_happens_when_you_have_a_disease_doctors_can_t_diagnose
Jennifer Brea ignored all her symptoms, followed her doctor’s recommendations and forced herself to walk home after an appointment, taking his word that perhaps her problem was all in her head. She has not returned to her prior level of functioning since that walk home.
I think it’s almost impossible for a normal healthy person to imagine functioning where exertion makes you worse, but this is the daily reality for person with ME/CFS. The unfortunate name given to this devastating illness has greatly contributed to the ignorance and disbelief prevalent among society and the medical profession as to its true nature.
And pacing per se is not a treatment - it’s a means of coping, much as using crutches enables someone with a broken leg to ambulate; crutches help prevent further damage to a broken leg, but by themselves do not cause healing.
And counseling, while it may help a person come to terms with ME/CFS (inasmuch as it is possible to come to terms with having your life come to halt and to be treated as though it is all in your head) again is not a treatment, no more than counseling someone with a broken leg will help their leg to heal.
MAYO CLINIC WEBSITE
Astoundingly, you state under "alternative" treatments that:
"It's difficult to determine whether these therapies actually work, partly
because the symptoms of chronic fatigue syndrome often are linked to mood and can vary from day to day."
Where do you get your information? Post-exertional malaise is not caused by someone’s mood, although PEM can definitely affect your mood. If you feel like you’ve been hit by a truck and run a marathon all at the same time, it will be difficult to maintain a positive attitude. Well, that’s PEM. Dr. Robert Naviaux of University of California at San Diego conducted a study which showed ME/CFS to be a hypometabolic state (see below).
Fluge and Mella of Norway are conducting studies showing promising results for some people with ME/CFS with the use of Rituximab, a chemotherapy drug, indicating a possible autoimmune component to ME/CFS. They happened upon this line of inquiry when a lymphoma patient who also had ME/CFS, had their ME/CFS symptoms improve when given Rituximab for lymphoma. (See below)
ME/CFS is associated with an increased risk for non-Hodgkins lymphoma (
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3434293/)
The level of misinformation as well lack of any meaningful information on your website is frightening. I urge you to educate yourselves and learn about the latest developments in ME/CFS research, most notably the following:
(1) The End ME/CFS Project, at the Open Medicine Foundation in Stanford, California, being led by Ron Davis, renowned geneticist who is leading a team with 3 Nobel Laureates and six National Academy of the Sciences members:
http://www.openmedicinefoundation.org/the-end-mecfs-project/
Dr. Davis’ son is extremely ill with ME/CFS and completely bedridden.
(2) Study done at UC San Diego, led by Robert Naviaux (Metabolic Features of Chronic Fatigue Syndrome);
http://www.pnas.org/content/113/37/E5472.full
(3) Clinical trial led by Fluge and Mella of Norway with Rituximab:
https://www.ncbi.nlm.nih.gov/pubmed/26132314
which strongly indicates that ME/CFS is an autoimmune condition.
(4) "CFS - The Central Cause - Mitochondrial Failure", Sarah Myhill;
http://drmyhill.co.uk/wiki/CFS_-_The_Central_Cause:_Mitochondrial_Failure
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2680051/
There are treatments which can help ameliorate comorbid conditions such as orthostatic intolerance and postural orthostatic tachycardia syndrome. Latest research indicates abnormalities with glucose metabolism and consequent amino acid deficiencies as the body uses amino acids to produce energy when the normal mechanism fails. Supplementation with various amino acids (such as branched chain amino acids) thus can help with energy metabolism. Sleep difficulties can be managed with various supplements (including niacin and l-theanine) which increase GABA or sensitive GABA receptors. D-ribose helps produce ATP and can help with functioning. And the list goes on.
This is like plugging holes in a dike - it won’t resolve the underlying condition but can help with symptoms until the central cause and a solution are found. Unfortunately, doctors who are knowledgeable about ME/CFS are extremely rare and patients for the most part have been left on their own to find solutions inasmuch as possible, while avoiding doctors and treatments which cause harm. (I speak from experience here, having suffered from ME/CFS for nineteen years; prior to getting ill, I worked full-time, raised a family and was physically very active; my life changed overnight.)
I would greatly appreciate your consideration of these matters and look forward to hearing from you.
Sincerely,
Mary Barker