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Beware of Aiding in the Burial of ME!

/ Gabby Klein / 2 Comments

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Since the Lake Tahoe outbreak of the distinct neuroimmune disease myalgic encephalomyelitis (ME), the US Centers for Disease Control and Prevention (CDC) has extended all their efforts in minimizing, conflating, misbranding, wrongly defining the disease in an attempt to bury the facts and reality of this severely disabling chronic disease affecting an estimated million American men, women and children.  The purpose of their malfeasance is to evade and deflect responsibility for this burdened pandemic.

One of CDC’s methods of cover-up is to refuse to adopt and to diverge from the authentic criteria for ME authored by international ME experts (Ramsay’s, CCC & ICC).  They have managed this by producing and/or acquiring faulty, overly broad criteria that do not describe the actual immunological, neurological and infectious nature of the disease.  Their latest offense is the acquisition of the IOM/SEID criteria. They have used the Institute of Medicine (IOM) (now called National Academy of Medicine) which is perceived to be an independent private organization when in effect most of their work is paid for by HHS – not exactly an unbiased partner. The charge and parameters of the IOM work were set up and controlled by HHS (leaving out many studies into the immunological and infectious nature of the disease) They have done this in an attempt to give their re-branding and redefining effort false legitimacy.  In actuality, this new criteria is yet another vague, ill-defined, fatigue-based definition.

Organizations who claim to represent #pwME like SMCI and MEAction have banded together with the CDC to aid in legitimizing this bad definition which is overly broad and does not define ME.

They have done this by:

  • Sponsoring and arranging a press briefing immediately after the release of the report.
  • Collaborating with CDC with their Technical Development Workgroup (TDW) to aid in embracing and inscribing the faulty definition to the CDC website (list of participants).  MEadvocacy, the patient organization representing #pwME issued a blog explaining why they opted OUT of this workgroup.
  • Collaborating with CDC to work on the new toolkit for healthcare providers and medical continuing education to teach and disseminate the IOM/SEID criteria.

Their latest “service” to the CDC is with their guileful inclusion of the ‘consideration of the recommendation from the IOM relating to ME/CFS’ in their proposed Senate resolution S.Res.508 – dated May 15, 2018,  introduced by Senator Markey and co-sponsored by Senators Collins, King, and Van Hollen to raise awareness about ME/CFS of the following language:

“Resolved, That the Senate

…

(3) encourages—

(A) the National Institutes of Health and other Federal agencies to work with experts, stakeholders, and individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome to—

(i) consider the recommendations of the National Academies of Sciences, Engineering, and Medicine relating to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome;

…”

Remember the National Academies of Sciences was formerly called the “Institute of Medicine”.  So, the Resolution which was drafted by MEAction and SMCI includes a push to implement the IOM recommendations.  Since these organizations were the ones who suggested the draft of the Resolution, they could have added anything, yet they proactively suggested adopting the IOM recommendations. [edited to include exact wording of the specific part of the Resolution and to clarify]

These are the IOM recommendations they are alluding to:

1 – Physicians should diagnose ME/CFS (with IOM criteria), and a new ICD code should be assigned. (please note that  “SEID” or  “ME/CFS” has no US ICD classification or code. The ill-defined conflated term violates ICD rules by combining diagnoses from different ICD sections).

2 – HHS should develop a toolkit for medical practitioners (based on the IOM).

3 – A multidisciplinary group should reexamine the IOM criteria when firm evidence supports modification, or in no more than 5 years.

4 – The committee recommends that this disorder be renamed “systemic exertion intolerance disease” (SEID). SEID should replace ME/CFS for patients who meet the criteria set forth in this report.

The above Senate Resolution is in recognition of May International Awareness month for the disease.  It details some basic stats (some faulty one like women are 4 times more likely to get the disease and neglects to include the cluster outbreaks and blood donation bans due to infectious components and/or etiology as well as state this disease kills patients), the financial burden and the general need for funding, medical care, and education.  Why not just stop it at that? Why did MEAction and SMCI insert the IOM recommendations in this resolution – except for aiding CDC in their burial of the disease, myalgic encephalomyelitis?

Myalgic encephalomyelitis is the distinct severely disabling, multi-system chronic disease that appears in epidemic and a sporadic form.  The symptoms of ME are numerous and include but are not limited to the following: post-exertional collapse, muscle and joint pain, enlarged lymph nodes, chills, low-grade fever, vertigo, extreme fatigue and weakness, cognitive impairment (delayed processing, aphasia, short-term memory loss, etc.), cardiac problems, orthostatic intolerance, sleep dysfunction, headaches, allergies, mold and chemical intolerance, frequent reactivated infections and co-infections.

Myalgic encephalomyelitis is not chronic fatigue syndrome nor is it systemic exertion intolerance disease nor is it chronic fatigue. One cannot claim to represent the entire community when, in effect, not only are they advocating for and promoting recommendations for faulty criteria but, they are aiding in the full burial of the distinct disease ME.

NOTHING ABOUT US WITHOUT US

Organizations and advocates who promote the IOM criteria DO NOT represent #pwME-ICC.  Falsely branding themselves as ME organizations and advocates is deceptive and harmful to this severely ill patient population.  Their attempt to speak for #pwME-ICC when approaching government officials or serving on government or private committees concerning the disease is not authorized by #pwME-ICC.  They are in effect aiding CDC to conflate and confuse while attempting to bury ME-ICC.

The ‘Mah Nishtanah’ of ME

/ Gabby Klein / 14 Comments

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The Jewish Holiday of Passover celebrated this past month, as it is every spring, commemorates the liberation of the Israelites from slavery in Egypt.  Its feature is the Seder when family and friends join together for an elaborate festive meal with specific customs and rituals. For many families, one of the highlights of the Seder night is the Mah Nishtanah, the “four questions” recited by the youngest members of the family.  The questions are about the difference between this night as opposed to all other nights and its purpose is to stimulate interest and thought about the history and traditions involved with Passover.

Isidore Rabi, a winner of a Nobel Prize in physics, was once asked why he became a scientist. He replied, “My mother made me a scientist without even knowing it. Every other child would come home from school and be asked, ‘What did you learn today?’ But my mother used to ask a different question. ‘Izzy,’ she always used to say, ‘did you ask a good question today?’ That made the difference.”

In the tradition of the questions of  ‘mah nishtanah’, I would like to stimulate thought about the history, actions, and state surrounding the acquired neuroimmune disease Myalgic Encephalomyelitis (ME) which manifests itself in epidemic and sporadic form and affects an estimated million American men, women, and children.  There is no FDA approved treatment to date regardless of the fact that it leaves the majority of sufferers disabled from work, housebound or bedbound – some for decades.

From the beginning, when representatives of the CDC were called down to investigate the outbreak at Lake Tahoe in the 1980’s, CDC and other US health agencies have mistreated this disease which has resulted in incalculable harm to the million American men, women and children with ME.  Every item questioned below are actions the government has taken or refused to make based on their attempt to disappear the reality and facts of the real acquired neuroimmune disease ME.

Following the form of ‘mah nishtanah’ questions as in “on all other nights we eat leavened or unleavened bread; tonight we eat only matzah”, here are the questions for ME.

Mah Nishtanah ME Questions

Why is it that:

  • All other complex chronic diseases are named with people’s names, geographical locations or distinctive feature; this complex chronic disease is falsely branded “chronic fatigue syndrome” – after a common symptom of fatigue? (see how diseases are named here)
  • All other complex chronic diseases are defined by non-government medical experts in that specific disease;  this complex chronic disease is repeatedly ill-defined by the government (CDC)? (see Frank Twisk paper here)
  • All other complex chronic diseases are taught in depth in medical and nursing schools; this complex chronic disease is either not taught at all, or mentioned dismissively?
  • All other complex chronic diseases have a medical expertise assigned to them with ample nationwide practitioners caring and treating patients;  this complex chronic disease does not have a distinct medical expertise assigned to it and has very few knowledgeable doctors caring and treating patients?
  • All other complex chronic diseases are placed in a specific NIH Institute who claims responsibility for funding research for it; this complex chronic disease has not been placed in any particular NIH Institute?  (it is currently situated in the Office of Research on Women’s Health which has no specific budget set aside for research)
  • All other complex chronic diseases receive NIH funding commensurate with the disease severity and burden;  this complex chronic disease gets a pitiful fraction of appropriate funding? (see table here)
  • All other complex chronic diseases that render patients unable to of a fair chance to secure Social Security Disability payments; this complex chronic disease has a high rate of denial for SSD, regardless of the severity of symptoms and the disabling nature of them?
  • All other complex chronic diseases that appear in epidemic form are studied for their infectious nature; this complex chronic disease which has appeared in over 50 outbreaks worldwide since the 1930’s (see list here) yet its infectious nature is mostly ignored and covered up by CDC?
  • All other complex chronic diseases have appropriate recommendations for FDA approved treatments; this complex chronic disease has no FDA approved treatments and has recommendations for treatments that are harmful to people with ME (graded exercise therapy [GET] and cognitive behavioral therapy [CBT])? (see a warning about GET from Workwell Foundation here)
  • All other complex chronic diseases that are biological in nature are described, defined and studied as a biomedical disease; this complex chronic disease is falsely labeled, defined and studied as a psychosomatic condition?

Once is happenstance.  Twice is coincidence.  Three times, it’s enemy action.  – Ian Fleming

All these discrepancies and discriminatory actions by HHS are not coincidental.  They all serve the purpose to minimize, marginalize this disease and deflect responsibility from the health agencies whose charge it is to “for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.”

The month of May is awareness month for ME.  It is time to ask the hard questions such as:

  • Why have the government health agencies ignored, neglected and covered up this severely disabling acquired multisystem disease for decades?
  • Why did the government health agencies enable the psych lobby to highjack this disease when they have known for decades that this is a biomedical disease?
  • Why are they so reluctant to properly name and define this disease as recommended by the medical experts and community?
  • How much money has the government withheld with their refusal to properly fund this disease and by their continuous denial of disability coverage?  

This May patients and advocates need to ask deep-seated questions and demand answers. With the insistence and demand that the proper name (myalgic encephalomyelitis) with the appropriate definition (ICC) be used, it will force the government to finally distinguish ME from fatiguing and psychosomatic conditions. It is with this most important distinction that meaningful change will take effect.

HHS Refuses to Correct their Wrongful Branding​

/ Gabby Klein / 13 Comments

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I wish to thank advocate Eileen Holderman for her contributions to this blog post.

The Department of Health and Human Services (HHS) refuses to use the name myalgic encephalomyelitis (ME) in spite of the fact that it is being used worldwide by ME experts, advocates and patients. Instead, HHS insists on using their demeaning moniker  – chronic fatigue syndrome (CFS). Their refusal to use the proper name for this disease ignited a long course of government malfeasance, corruption and marginalization of one million American men, women and children suffering from ME.

Naming and Classifying the Disease 

In the mid-1950’s, an epidemic broke out at the Royal Free Hospital in London. Following that epidemic, the name myalgic encephalomyelitis was first used by ME pioneer Dr. Melvin A. Ramsay (as suggested by Dr. Donald Acheson).

Since 1969, the World Health Organization (WHO) has classified myalgic encephalomyelitis under Neurology – ICD-10, G93.3.

However, in the 1980’s, following the Lake Tahoe, Nevada outbreak of ME, the U.S. Centers for Disease Control and Prevention (CDC) chose a different name for the disease. In their quest to minimize the seriousness and potential huge impact of the disease, CDC coined it with the trivializing name – chronic fatigue syndrome (CFS).

In 2015, The Institute of Medicine (IOM) was contracted by HHS to devise another government constructed name and criteria. IOM created a new demeaning name for the disease – systemic exertion intolerance disease (SEID), which has been rejected by the majority of experts, advocates, and patients. The name is misleading because it implies that patients are only ill when they exert themselves and are otherwise fine if they don’t – which of course is not true.

The Fiction of CFS

The name – chronic fatigue syndrome – along with the government criteria, are an HHS fictional construct.  In their attempt to disappear the serious neuroimmune disease ME, HHS deliberately chose the name chronic fatigue syndrome because it could be easily conflated with the common condition of chronic fatigue.  Their intention was to create a false impression that those with CFS were primarily contending with one symptom – fatigue – rather than a vast number of symptoms affecting multiple body systems.

The scientific and medical communities are responsible for naming and developing criteria for diseases – not governments. ME expert researchers and clinicians named the disease myalgic encephalomyelitis and developed accurate criteria for the disease (CCC, ICC). HHS should not hijack the private scientific and medical sector’s authority.

The Reality of ME 

Myalgic encephalomyelitis is a neuroimmune disease (with an infectious component and/or etiology) appearing in epidemic and sporadic forms. ME affects multiple systems of the body: neurological, immune, cardiovascular, endocrine and energy systems. The illness typically has an acute onset of a viral or bacterial infection or toxin or chemical exposure.

The symptoms of ME are numerous and include but are not limited to the following: post-exertional collapse, muscle and joint pain, enlarged lymph nodes, chills, low-grade fever, headaches, extreme fatigue and weakness, cognitive impairment (delayed processing, aphasia, short term memory loss, etc.), orthostatic intolerance, dizziness, sleep dysfunction, allergies, mold and chemical intolerance, frequent reactivated infections and co-infections. The symptoms of ME leave patients severely sick and disabled for decades and many die prematurely from complications of the disease. Currently, there is no cure for the illness.

About one million American men, women, and children suffer from ME and about 17 million worldwide. Most patients are disabled and cannot work and about 25% are bedbound and cannot care for themselves.  Studies show that the quality of life for patients with ME  is one of the poorest compared to other chronic diseases.

“In my experience, it [ME] is one of the most disabling diseases that I care for, far exceeding HIV disease except for the terminal stages.”—Dr. Daniel Peterson

The Repercussions of a Harmful Name

The CDC manufactured name – chronic fatigue syndrome – and the CDC criteria  (see next blog post), have harmed patients worldwide and have resulted in the following:

  • Inadequate federal funding – For over 30 years, the National Institutes of Health (NIH) has refused to adequately fund meaningful biomedical studies for the disease. ME receives less federal funding than hay fever, and a mere 2% of other similarly burdened diseases, yet has an enormous cost to our nation’s economy. From the start, NIH and CDC plotted to eliminate the disease by focusing on ‘fatigue’ in the name as evidenced by the letter the late Dr. Straus of NIH wrote to Dr. Fukuda of CDC in which he stated: “ I predict that fatigue itself will remain the subject of considerable interest but the notion of a discrete form of fatiguing illness will evaporate….I consider this a desirable outcome.” (see letter part 1 and part 2  provided by advocate Craig Maupen)
  • Stagnant scientific advancement – The lack of NIH funding has stalled impactful scientific advancements.  Although over 5,000 scientific papers have been published on the disease, many were privately funded and most findings of biomedical abnormalities were dismissed or not replicated by HHS.  The health agencies’ use of the name chronic fatigue syndrome (and flawed criteria) ensures paltry funding and controversy, which are reasons some researchers will not study the disease.
  • Insufficient and erroneous medical education  –  HHS has spread misinformation about the disease on their websites and in their medical CMEs and materials. Despite advice from ME experts, advocates and members of the federally appointed Chronic Fatigue Syndrome Advisory Committee (CFSAC) to correct the inaccurate medical information, HHS refuses to do so.  They continue to use chronic fatigue syndrome and often publish materials that describe the common condition of chronic fatigue instead of the neuroimmune disease ME.
  • Lack of expert clinicians – Lack of medical education has resulted in a scarcity of clinicians. The majority of patients do not have access to an ME specialist and are left to deal with local doctors, many who are not knowledgeable about the disease – leaving patients without proper medical care. The stigma attached to the disease due to the name and the intentional confusing medical information from HHS, are reasons such few doctors go into this field.
  • Recommendations of harmful treatments – HHS’s erroneous medical information has led unknowing clinicians to recommend harmful treatments to their ME patients, such as prescribing unneeded antidepressants, graded exercise therapy (GET) and cognitive behavioral therapy (CBT). Many patients have been seriously harmed by these recommendations, some permanently. The use of the flawed name – chronic fatigue syndrome – and flawed criteria deliberately conflates patients with ME with some who do not have ME. Therefore, treatments which are harmful to ME patients which may help those without ME, get wrongly attributed as successful treatments for ME patients, due to the conflating of the patient pool.
  • No FDA-approved treatments – The U.S. Food and Drug Administration (FDA) denied approval of Ampligen (an immune modulator shown to be effective in the drug trial). FDA has no approved drugs for ME patients and their inactions are influenced by HHS’s description of the “condition” as primarily “fatigue.”
  • Psychiatric bias – The CDC’s pseudoscientific name (CFS) and criteria enable a psychiatric bias to proliferate about the disease.  Some in the psychiatry and psychology fields (Wessely, Chalder, Sharpe, White, etc.) and in other fields (Gill, Walitt, Saligan and the late Straus and Reeves, etc.) intentionally misclassify the disease as a psychosomatic condition – in spite of overwhelming scientific evidence that classifies the disease as biological.  It is lucrative for psychiatrists and psychologists, as well as opportunists from other fields, to hijack a disease with a trivial and unscientific name – especially when government health agencies give preference and award grants to studies with a psychiatric slant and because health insurance companies reward those willing to put a psychological spin on a disease that isn’t psychological.
  • Difficulty getting approved for disability insurance – The inaccurate name and medical information are co-factors why many ME patients have a grueling time, no matter how severely ill, getting approved for disability benefits. In fact, the U.S. Social Security Administration (SSA) frequently denies patients benefits during the initial application process, citing that “fatigue” doesn’t qualify them for disability. Additionally, the psychiatric bias connected to the name and criteria of CFS causes many patients to lose their ERISA based disability insurance after the two-year period because ERISA only covers psychiatric illnesses for two years – despite the fact that the illness is classified as biological.
  • Rejection of health insurance reimbursements – The trivial name gives health insurance companies ammunition to deny payments for important tests such as two-day CPET, NK cell function, and cytokine panel blood tests, among many others, as well as for efficacious treatments such as antivirals and immune modulators.
  • Stigmatization of patients – The media frequently propagates government propaganda and a psychiatric bias about the disease. Many (except for a minority of informed journalists) don’t report on the abundance of published scientific biomedical findings, but instead use faulty government information; some because they wrongly defer to the government health agencies as the ultimate authority rather than investigate; and some because they pander to the government health agencies to glean favor and receive preferential treatment for future articles. Editors routinely use chronic fatigue syndrome instead of myalgic encephalomyelitis – and worse – often drop the word ‘syndrome’ from the headline of the article – downgrading the disease of ME to a condition of chronic fatigue. The unscientific name gives the media dispensation to write unscientific articles.
  • Marginalization of patients – Despite plenty of scientific evidence about ME, many family members and friends of patients often fall prey to the deception started by the government and promoted by the media. Patients are often subjected to comments such as: “I’m tired too, but I am able to push through it – why can’t you?”; “Go jogging – it will make you feel better!”  Because the name chronic fatigue syndrome obsessively focuses on one of a vast number of symptoms a patient suffers from – patients are wrongly labeled lazy, sleepy or merely tired.

HHS Must Rectify their Indefensible Nomenclature

For three decades, HHS has harmed ME patients by using their degrading name – chronic fatigue syndrome – for the disease – causing the following damaging results: paltry federal funding, choking consequential medical advances, erroneous medical education, a scarcity of expert researchers and clinicians, recommendations of harmful treatments, no FDA-approved drugs, proliferation of psychiatric bias, obstacles getting approval for disability insurance and health insurance reimbursements, and stigmatization of patients by the media, the public, family and friends.

And for three decades, ME advocates, patients, caregivers and experts have called for HHS to stop their harmful practices and use the name myalgic encephalomyelitis exclusively and resolutely!*

*Look for the upcoming blog post about ME criteria that will address how to eradicate the name chronic fatigue syndrome and retire the CDC and IOM criteria.