The Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Common Data Elements (CDE) Working Group and the National Institute of Neurological Disorders and Stroke [NINDS]/Centers for Disease Control and Prevention (CDC) CDE Team released their draft version of the ME/CFS CDEs for public review on 12/15/2017. Public comments are to be submitted by 1/31/2018.
The general NINDS CDE section explains the purpose of the CDEs as follows:
“Many of the CDEs will overlap across study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.”
MEadvocacy.org has vigorously advocated for the adoption and use of criteria created by ME experts, like the International Consensus Criteria (ICC), for selecting individuals for research. The aspired goal is to make sure the cohorts being studied include patients who suffer from the same disease (ME) - in exclusion of those suffering from other conditions or idiopathic fatigue.
Broad criteria created by the CDC like the 1994 Fukuda or 2015 IOM do not ensure patient selection will exclude those who suffer from other fatigue-inducing illnesses. (as shown by Leonard Jason and Frank Twisk published works)
An expectation that the common data elements (CDEs) would be based on clearly defined patient populations does not appear to be met by the current CDE draft because NIH/CDC does not require a specific research criterion to be used for all the federally funded studies. Additionally, the CDEs are too vague in their description of post-exertional malaise (PEM) thus risking inclusion of patients with other diseases in studies for ME.
MEadvocacy.org represents patients who fit the experts’ criteria such as the International Consensus Criteria (ICC) for myalgic encephalomyelitis - including the severely ill. In reviewing the proposed common data elements, they fail to accurately select a true ME population. The conflation of persons with ME (pwME-ICC) with persons suffering from conditions with similar symptoms such as CFS, fibromyalgia, postural orthostatic tachycardia syndrome (POTS), Ehlers-Danlos syndromes (EDS), depression or idiopathic fatigue will confuse study results which will only cloud and continue to stunt scientific advancements of the disease ME.
Historically, ME as defined by the ICC has been buried under CDC overly broad definitions such as Holmes, Reeves, Fukuda and most recently IOM. Additionally, the US government health agencies have refused to adopt definitions created by actual ME experts with extensive hands-on experience in treating and researching the disease. This government refusal to recognize ME has caused a lack of research in the exclusive #pwME-ICC (#MEICC) population. The proposed CDEs further aggravate the problem, because they leave it up to the researcher to pick any research criteria of their choosing. Thus, the ME population will again not be clearly identifiable within the broader CFS patient population.
In their draft, the CDE working group for PEM acknowledges they neglected the severe population. They state: “While there is little formal research on subtypes of ME/CFS as it pertains to PEM, severely impaired patients may experience PEM with significantly smaller levels of exertion. Recommendations made by this working group may need to be modified or adapted for this group.”
CDEs Do Not Replace Case Definition
NINDS and CDC do not recommend which research definitions federally funded ME researchers should use. In their CDE description, they state:
“Researchers conducting the studies using CDEs will determine the case definition and enrollment criteria that best fit their research objectives. The CDEs are methods of collecting data in a standardized manner… The intention is that CDEs will be applicable independent of the research case definition.”
This is an extremely troubling statement from NIH/CDC!
They are advising federally granted researchers to choose whichever enrollment criteria they wish to use. They state: “whichever criteria best fit their research objectives” - so if, for example, they want to show GET is good for pwME, that’s fine - just use the inadequate Reeve’s criteria!
The CDEs are meant to serve as a method of collecting unified data in a standardized manner, independent of criteria. The real issue here is if the data is taken from cohorts that do not suffer from ME, what disease is NIH/CDC looking at with their CDEs?
The CDE PEM Draft
Since PEM (or more accurately, PENE) is the hallmark and distinctive symptom of an ME diagnosis, great care should be taken in its description and definition. Yet, the current CDEs define PEM as a positive finding of only 1 of the following 5 questions taken from the DSQ questionnaire. (with a moderate severity and frequency)
- Dead, heavy feeling after starting to exercise
- Next day soreness or fatigue after non-strenuous, everyday activities
- Mentally tired after the slightest effort
- Minimum exercise makes you physically tired
- Physically drained or sick after mild activity
Any one of these questions can be applied to many other illnesses or basically be a result of deconditioning. They do not define PEM per the Canadian Consensus Criteria (CCC) nor Post- Exertional Neuroimmune Exhaustion (PENE), in the International Consensus Criteria (ICC) which require a much more significant impact on daily living and is a unique experience seen in ME.
The ICC was created by ME experts for diagnostic and research purposes. The IC Primer lists many recommendations for biological tests to be taken to confirm a proper ME diagnosis - not simply relying on subjective questionnaires.
The goals of the CDEs are admirable but, it can only be effective if the data being looked at and shared are actually based on the distinct disease being discussed. For example, if the CDEs were used to compare ME with major depressive disorders (MDD) and the ME cohort mistakenly included those suffering from MDD and not ME - it will skew the picture.
MEadvocacy’s concern is that the current NINDS/CDC CDEs draft will not accomplish its intent because:
they do not specify the research criteria to be used across all federally funded studies (i.e the ICC)
they rely on subjective questionnaires most of which were not created for the distinct disease ME
- PEM/PENE, the hallmark feature of ME, is very poorly defined.
Therefore, MEadvocacy recommends that:
- All federally funded researchers use the ICC which was created by ME experts for diagnostic and research purposes.
- New questionnaires be designed which are strictly created with ME patients in mind.
- PENE be strictly defined as per ICC in order to weed out those who suffer from fatiguing conditions - not ME
What You Can Do
If you agree with MEadvocacy’s recommendations, you can send an email with MEadvocacy’s blog (copy and paste or a link), stating that you endorse MEadvocacy’s recommendations to NINDSCDE@emmes.com (due date is 1/31/2018)
* Please note - CDE instructions state: After January 31, 2018, feedback can still be sent at any time through the website or by emailing NINDSCDE@emmes.com. Proposed changes will be brought to the oversight committee (OC) for review.
File:USMC-09611.jpg. (2017, September 15). Wikimedia Commons, the free media repository.
Guest editorial by Jerry Seidel, President May12.org*
Martin Luther King Jr. (MLK), Baptist minister and civil rights activist, never organized sit down talks with grand wizards of the Ku Klux Klan (KKK). He could have tried to teach them that they were wrong, but he never did that because he knew it would be fruitless. Imagine him sitting there with grand wizards in their white robes, masks, and caps. It would have been a pointless effort.
In fact, if it helped anyone it would have accommodated the KKK by giving the wrong impression that they are a reasonable group as opposed to the hateful criminals they really are. Instead, he brought the fight to the media through protests and approached lawmakers in Washington D.C. Martin Luther King Jr. knew that the best way to affect a change and stop their ongoing crimes was through the education of the public and the assistance of lawmakers who uphold our laws.
Hatred is an evil motive, but not the only one. The love of money above all else is a cause capable of creating great evil in the world. Racism and the love of money can both inflict massive pain, suffering, and death on the masses.
It is ironic that another group perpetrating evil also wear white robes, masks, and caps. I am referring to corrupt medical researchers. The powerful researchers love money above all else. Think of the Centers for Disease Control [CDC], the National Academy of Medicine, formerly called the Institute of Medicine [IOM], Infectious Diseases Society of America [IDSA], and American Lyme Disease Foundation [ALDF]. The USA, Canadian, UK, and Australian medical authorities are all corrupt because:
- denying proper diagnosis is a huge cost savings
- prescribing ineffective treatments boosts profits
avoiding implications of gross scientific misjudgments which have allowed an epidemic of diseases protects them from criminal and financial litigation.
Lies are necessary to maximize profit and minimize fault, while they are keeping us sick.
The public would be outraged if they knew the extent of the deception perpetrated by medical agencies. Modern medicine is loaded with skilled manipulators who have convinced the public that they use good science. We cannot correct system-wide corruption from within. Many have tried for decades without success. We need to go over their heads. We must make them do the right thing through educating the public about their corruption and crimes and by utilizing lawmakers and the law to succeed.
Just stating what we need is not good enough. The public must know that they are criminals and not merely mistaken scientists. The current dominant advocacy strategies portray them as mistaken scientists. That strategy won't change anything. Their work is more than flawed. It is fraud. Just two examples of fraud are:
The UK Pace Trial research promoting using of cognitive behavioral therapy [CBT] and graduated exercise therapy [GET] as effective treatments for chronic fatigue syndrome [CFS]. See this link for David Tuller’s articles documenting the fraudulent activities of the researchers who had a conflict of interest in the outcome of this study due to their relationship to insurance companies.
The “Dearborn” conference for the standardization of diagnosing Lyme disease. See this link for how the criminals falsified the Lyme disease case definition and fraudulently used the two-tier testing to validate the LYMErix vaccine.
They will always win the debate if the public believes they use good science. The public needs to know about the corruption and the routine lie "we use good science".
Just as MLK wouldn't try to work with the KKK, it is useless for us to try and work with the CDC, IOM, FDA, IDSA, ALDF and the others. They are lying to keep us sick for monetary gain. One cannot convince; a bank robber to stop stealing by telling him it is wrong, telling a racist it is wrong to hate, or telling a terrorist it is wrong to kill. Evildoers and lawbreakers don't care. We must speak to the public to educate them via protests with like-minded people who can spread the truth through all forms of media and use the law to put an end to their crimes.
*Note: MEadvocacy.org is a project of May12.org, a 501(c)(3) not-for-profit corporation whose mission is to raise global awareness and education for complex immunological and neurological diseases, including Myalgic Encephalomyelitis (ME). As such, donations from USA citizens are tax-deductible as allowed by law.
Follow May12 on Twitter: @May12org
The Chronic Fatigue Syndrome Advisory Committee (CFSAC) held meetings on Dec. 13 & 14, 2017. Videos and transcripts of the meeting can be found here.
CFSAC provides advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to Myalgic Encephalomyelitis and Chronic Fatigue Syndrome.
Although CFSAC used to meet in person 4 times a year, their meeting frequencies have been reduced to twice a year with only one live meeting and the other a teleconference. In 2017, CFSAC had meetings in January and June - with a third meeting added in December.
This meeting included updates from the following organizations:
- CFSAC’s DFO on status of implementation of recommendations from the last CFSAC meeting
- National Institute of Health
- Centers for Disease Control and Prevention
- Food and Drugs Administration
- Social Security Administration
- Health Resources & Services Administration
- Agency for Healthcare Research & Quality
- Department of Veteran Affairs
- Simmaron Research, Inc
- Massachusetts CFIDS/ME & FM Association
- ME Action
- Report from the Pediatric Education Working Group and Parent Information Center
RESEARCH UPDATE PRESENTATIONS
Two Presentations were given about research updates.
- Research Update on Adults given by Jose Montoya, M.D. (CFSAC Member)
- Research Update on Pediatric given by Rosamund Vallings, M.D. (Invited Speaker) Howick Health and Medical, Auckland, New Zealand
During Dr. Montoya’s presentation, he asked Dr. Unger to confirm that the CDC had removed materials recommending GET (Graded Exercise Therapy) and CBT (Cognitive Behavior Therapy) as treatment options.
While Dr. Unger verbally confirmed to Dr. Montoya that the CDC removed GET and CBT materials, as of this blog post there are still links from the CDC website to materials recommending graded exercise and behavioral therapy.
(One example is this link to Stacks here in Spanish for materials recommending CBT and GET. The English version has been removed.)
(Slide from Dr. Montoya’s presentation)
The working part of the meeting was a discussion of the Medical Education Work Group’s recommendations. Final recommendations will be posted on the CFSAC webpage.
Both days included public comments from patients and advocates.
A running theme from the public comments was:
- the lack of urgency from the government health agencies
- the faulty and harmful information posted on CDC website and mailed out to clinicians - without retractions
- CDC website not fulfilling the requests of previous CFSAC recommendations
- the dire circumstances of patients denied disability
- patients dying while waiting for treatment information to get to their doctors
Colleen Steckel, an advisory committee member here at MEadvocacy spoke about the mistreatment of patients by providers.
My name is Colleen Steckel. Diagnosed at age 29 with CFIDS and sick for 28 years. I am an advocate and support group leader and have experienced and witnessed indescribable suffering that has led to at least 37 untimely deaths in the last 2 years alone.
You have heard for decades how severely debilitating myalgic encephalomyelitis is for those of us who fit the International Consensus Criteria. Research funding levels and lack of doctor education show a lack of understanding about the breadth of this epidemic. Know that our doctors are coding us as CFS, ME, Fibro, POTS, etc. so disease prevalence is buried.
Here is a perfect example of the rampant lack of understanding we face every day. As of last week, Mayo Clinic states that treatment for CFS is:
“Gradually increasing the intensity of your exercise over time may help reduce your hypersensitivity to exercise, just like allergy shots gradually reduce a person's hypersensitivity to a particular allergen.”
According to this, ME is NOT CFS. We need accurate information disseminated for ME as per the ICC.
The horror stories of mistreatment coming from patients who go to the top clinics like Mayo and Cleveland Clinic make it clear the CDC has not shared our experts’ knowledge about the complex nature of ME’s broken oxygen exchange system, impaired energy production and immune and autonomic abnormalities. This leads to unnecessary suffering and early deaths.
With the loss of Dr. Lerner and now Dr. Lapp retiring, the fear rippling through the community because there are too few knowledgeable doctors is overwhelming. Every day that proper information does not reach our doctor means at least a million US citizens suffer without medical care another day. Patients who are more disabled than someone with congestive heart failure.
In an effort to bring to light the breadth of the suffering I will close with information gleaned from an online group with thousands of members sick with ME where hundreds of people responded to the following question.
What age did you get sick and how long have you been ill? The age of onset ranges from age 9 to 55. When I added the number of years of the first 278 people that posted this equaled 5,195 years of suffering. Take a moment to let that sink in… 5,195 YEARS for just 278 people. That’s an average of 18.7 years per person waiting for doctors to have the information they need to alleviate our suffering.
That sampling of just a small percentage of our community should shake everyone here to their core. This neglect by our healthcare system is incomprehensible, a disgrace, unfathomable, unconscionable, and criminal.
Eileen Holderman, long time ME advocate who served on CFSAC for 4 years, (found on twitter @TurnItUp4ME) spoke about the history of CFSAC recommendations for the CDC to update their website and educational materials which still need implementing today.
Good morning to the Committee Members and to the ME community.
I’m Eileen Holderman, I’m an advocate.
As a former member of CFSAC, I served as Chair of the Subcommittee for CDC Website Review. For years, we made recommendations to CDC to improve the website so that it reflected the scientific facts and evidence of the neuroimmune disease Myalgic Encephalomyelitis. Unfortunately, the revisions CDC accepted were minimal and the site continued to appear as a site for the condition of chronic fatigue - not ME.
When my term on CFSAC ended, I wrote an open letter to Dr. Unger listing numerous issues remaining with their website focusing on the Toolkit and Resource Guide, touting CBT and GET, which were used as medical education guidelines for physicians and healthcare providers. For years, I and many advocates continued to ask CDC to remove the Toolkit and make the additional changes on their website. Despite our pleas, CDC made a decision to keep the Toolkit up on a CDC website called Stacks.
Then about 2015, I gave public comment to CFSAC, reading into the public record, excerpts from my open letter to Dr. Unger, urging CDC to take the Toolkit and Resource Guide down, among many other issues that still needed changes on their site.
About 3 months ago, I embarked on a Twitter campaign to press CDC to take their Toolkit down. Finally, 1 month ago, the Toolkit was taken down off the CDC site, called Stacks. However, the CDC Toolkit in Spanish remains up on the site!
More concerning to the ME community, is the fact that for about a decade, the CDC Toolkit was the official guideline for physicians and healthcare providers all over the US and in many parts of the world. In just 1 meeting at CFSAC, Dr. Belay announced 17 thousand Toolkits were mailed out to healthcare providers all over the US. Additionally, CDC made the Toolkit available via e-copies for healthcare providers to download.
As I speak today, doctors and healthcare providers in the US and around the world use the CDC Toolkit because CDC has still not advised the healthcare profession AGAINST using it – nor has CDC issued a warning to doctors of the harms prescribed in the Toolkit such as GET and CBT.
The stakeholders: expert researchers and clinicians, advocates, patients and caregivers need CDC to disseminate notices to all healthcare providers to stop using and referring to the Toolkit and its guidelines.
For the 17 million men, women and children suffering from ME around the world, this recommendation needs to be implemented right away.
LOOKING FOR CHANGES IN 2018
We will be watching the CDC closely to see how they respond to the issues raised - such as:
A full retraction of the toolkit replaced with information affirming that Graded Exercise Therapy (GET) is harmful to ME patients and should NOT be recommended and that Cognitive Behavior Therapy (CBT) is not a valid treatment for M.E.
Removing false and harmful information from CDC website as well as from the mainstream medical community like Mayo Clinic, Cleveland Clinic, etc.
Updating CDC website and educational material with information from the ME International Consensus Primer for Medical Practitioners. MEadvocacy has created an easy to follow ICC questionnaire. This is a good resource to share with doctors to understand the full range of myalgic encephalomyelitis.
The following are excerpts from the ME-IC Primer and materials on the CDC website should include this information:
Post- Exertional Neuroimmune Exhaustion (PENE pen׳-e)
“PENE is characterized by a pathological low threshold of physical and mental fatigability, exhaustion, pain, and an abnormal exacerbation of symptoms in response to exertion. It is followed by a prolonged recovery period.”
“Neurocognitive, sleep, autonomic and sensory disturbances, pain, headaches, and paresthesias are prominent neurological signs and symptoms. Cognitive impairments including slow processing of information, poor attention, word finding, and working memory are some of the most functionally disabling symptoms”
“Neuropathic viruses can infect and damage the brain, ganglia and immune cells. The initial infection may cause profound dysregulation of the immune system, which in turn may result in persistent infection or abnormal immune response. Activated immune complexes, including elevated levels of various cytokines, cause chronic inflammation against a background of immunosuppression, which makes the body more vulnerable to opportunistic infectious agents and may play a role in post-exertional flares and flu-like symptoms.”
Energy Production and Ion Transport Impairments and Cardiovascular and Autonomic Impairments
“Profound energy impairment suggests dysregulation of the mitochondria and cellular energy production, channelopathy, and ion transport. There is an inverse relationship between diurnal variation in blood pressure (BP) and fatigue. Impairments increase risk of cardiovascular events. Orthostatic intolerance (OI) suggests impaired cerebral circulatory autoregulation. Low oxygen consumption, stroke volume, and reduced circulation are associated with symptom severity and functional impairment.”
Fast tracking for FDA approved medications. There are medications shown to help ME patients including Ampligen, antivirals, Low Dose Naltrexone (LDN), etc. which should be made available as soon as humanly possible.
WHAT YOU CAN DO
Continue to support MEadvocacy’s mission:
Advocate for ME Recognition
Advocate for ME Definition
Advocate for ME Research
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-
TruthCures.org Lobbying on June 5, 2017
FOR IMMEDIATE RELEASE
Washington, D.C., June 5, 2017
Representatives of TruthCures are lobbying June 5-9th and meeting with Senate Judiciary Committee Members to turn over evidence and demand a hearing.
Patients and advocates are charging the USDOJ with failure to act on a whistleblower’s complaint of research fraud and falsification of information for personal financial benefit. Charge Sheets reveal fraud and racketeering within the CDC and private entities. The USDOJ was contacted in 2003 and still have yet to respond to the situation and prosecute the offending criminals.
The leaders from TruthCures/SASH (a group known as the Society for Advancement of Scientific Hermeneutics) state in their criminal charge sheets that there’s a common disease mechanism linking myalgic encephalomyelitis (ME), chronic fatigue syndrome (CFS), Lyme disease, Gulf War illness, fibromyalgia and autism.
Following the advice given by Jeff Sessions’ legal staff during the 2015 SASH lobbying efforts - TruthCures and SASH are now pursuing a hearing of the Senate Judiciary Committee to refer the Lyme Crime to the USDOJ for prosecution. This is the current mission.
Through a massive compilation of published scientific research and public-record documents, TruthCures and SASH, recognize the common mechanism of fungal-induced immunosuppression, known to the National Institutes of Health (NIH) as “Post-Sepsis Syndrome.” They report that such immunosuppression leads to the chronic reactivation of multiple viruses such as Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), HHV-6 and opportunistic infections, leading to cancers and an AIDS-like disease. TruthCures further shares evidence that the interaction of fungi with attenuated viruses in vaccine vials causes the reactivation of those viruses and ultimately, the diseases they are meant to prevent.
The group’s primary charge is the USDOJ’s failure to take action on a whistleblower complaint that was filed in July 2003 by Kathleen Dickson, a former analytical chemist at pharmaceutical giant Pfizer. Her complaint that CDC officers, Yale University and others committed research fraud to falsify the current Lyme disease case definition (aka Dearborn) and the two-tiered testing in order to falsify the outcomes of the OspA vaccine (LYMErix), which was pulled from the market after an FDA ultimatum to the manufacturer.
The very same government employees who committed these crimes gained substantial financial rewards from a monopoly on all tick-borne diseases, vaccines and test kits. Additionally, their falsification of the Lyme disease case definition and treatment guidelines have left 85% of chronic Lyme sufferers unable to obtain diagnosis, treatment, or insurance coverage for their AIDS and cancer-like illness.
An abundance of scientific and historical evidence are presented in the charge sheets. Many of the citations refer to the criminals’ own peer-reviewed, published research papers and patent documents, to deny basic healthcare to an estimated 30 million sufferers in the United States.
Visit TruthCures.org for access to the full charge sheets.
May12.org is endorsing TruthCures’ lobbying efforts, and is dedicated to raising awareness of complex immunological and neurological diseases such as myalgic encephalomyelitis, chronic fatigue syndrome, Gulf War illness, fibromyalgia and chronic Lyme disease.
MEadvocacy.org is a project of May12.org.
History of May 12 International Awareness Day
This year marks the 25th anniversary since the late patient and staunch advocate, Thomas (Tom) Hennessy Jr, designated May 12th as the international awareness day for myalgic encephalomyelitis (ME) and other complex immunological & neurological diseases (CIND) - such as fibromyalgia (FM), Gulf War illness (GWI), multiple chemical sensitivity (MCS), and chronic Lyme disease (CLD).
Tom chose May 12th to memorialize the birth date of Florence Nightingale, the English army nurse who inspired the founding of the International Red Cross. Nightingale contracted a paralyzing CIND-like illness and became chronically ill. She spent the last 50 years of her life virtually bedridden, and despite being severely debilitated, started the world’s first school of nursing.
The Need to Raise Awareness for Diseases
Advocates for diseases have the challenge of raising awareness about the plight of their patients in order to educate the public and to raise much-needed funds for research and aid. Advocates for misunderstood and neglected diseases, such as the CIND diseases, have an added urgency to educate because of all the obfuscation and government health agency malfeasance impeding proper diagnoses, treatment, and a possible cure.
Fibromyalgia is characterized by chronic widespread pain and a heightened pain response to pressure. Due to the pharmaceutical companies’ advertising drugs for fibromyalgia, this illness has gained wide recognition. Unfortunately, due to lack of proper medical education about these diseases many patients who have ME or Lyme have been misdiagnosed with fibromyalgia leading to inappropriate and harmful treatment recommendations - such as drugs with adverse reactions and exercise which is contraindicated in patients who have ME.
GULF WAR ILLNESS (GWI)
Symptoms are similar to myalgic encephalomyelitis and chronic Lyme disease, leaving many veterans too ill to work. GWI patients have too often been ignored by the VA despite evidence of the serious biological nature of this illness.
CHRONIC LYME DISEASE (CLD)
Lyme disease or neuroborreliosis has left millions of people to suffer in isolation with an AIDS-like illness similar to post-sepsis. Victims are frequently misdiagnosed or denied any diagnosis at all.
The only CDC-sanctioned Lyme disease testing is ANTIBODY based. People whose immune systems are destroyed (immunosuppression) don't produce the required antibodies to get a positive test. The “Dearborn” case definition was put in place in 1994, when the now-failed Lyme vaccine, LYMErix was in the trial stage and it became known that the antigen used (a highly acylated lipoprotein, TLR2/1 agonist; triacylated, that's also shed by the organisms that cause Lyme disease) was causing adverse events that looked exactly like what we know as "chronic Lyme disease" or "post-treatment Lyme disease syndrome”.
The one priority needed in order to open up the floodgates so all Lyme victims may receive proper recognition, their disability payments, and correct treatment:
MULTIPLE CHEMICAL SENSITIVITY (MCS)
Many patients with these complex immunological & neurological diseases also suffer from MCS which is a debilitating disease leaving people unable to participate in society due to severe reactions to environmental toxins.
The Specific Challenge of Raising Awareness for ME
There are an estimated one million men, women, and children in the U.S. suffering from the complex neuroimmune disease ME. The majority of patients are so adversely affected as to render them disabled from any work with 25% totally bedbound! The hallmark symptom for ME is Post-Exertional Neuroimmune Exhaustion (PENE) often called Post-Exertional Malaise (PEM). Because of this symptom, activity exacerbates the illness.
The reason why ME patients have been suffering without any FDA approved treatments for decades - some dying young, others bedbound or disabled from work - is due to the negligence and malfeasance perpetrated by the US government health agencies.
Facts that have caused the sad state of affairs of ME:
CDC’s refusing the input of ME stakeholders to officially adopt the proper, historical name, myalgic encephalomyelitis and the repeated attempts to rename the disease with marginalizing names such as chronic fatigue syndrome (CFS), systemic exertion intolerance disease (SEID), and the confusing combination of ME/CFS.
CDC’s refusing the voice of ME stakeholders to officially adopt criteria created by ME experts such as the International Consensus Criteria (ICC) or Canadian Consensus Criteria (CCC) while persistently attempting to force overly inclusive criteria created by the government such as the Fukuda Criteria and the IOM criteria. (The IOM criteria have been shown to be as overly inclusive and vague as the Fukuda - read the paper by Dr. Leonard Jason and the paper by Frank Twisk!)
CDC’s continued misinformation and miseducation about the disease on their website as well as in their continuing medical education. The CDC has stubbornly refused to heed advocates recommendations to make all the proper changes including to remove CBT/GET and despite efforts by many advocates CBT/GET are still recommended by the CDC today - disregarding all the scientifically proven harm it causes ME patients.
HHS’ refusal to properly fund ME. Although its prevalence is higher than many other diseases, NIH funding for the disease is at the bottom of the list (247th out of 274). Additionally, studies looking at the quality of life of ME patients have shown to be lower when compared to other debilitating diseases like RA, cancers, and diabetes. There are currently over 6,000 medical papers on ME with important findings, yet investigators lack adequate NIH funding for the much needed large-scale replications.
The challenge in raising awareness for ME is the need to make the public aware of this government malfeasance. It is not enough to just educate about how horrible and disabling the disease is. We need to reveal the ongoing government malfeasance and shame HHS into an apology and positive action!
How to Raise Awareness
We need to raise public awareness about the malfeasance of HHS with regard to their negligence, purposeful distortion of the facts, and gross underfunding of ME and all complex immunological & neurological diseases. This can be accomplished by:
Calling or writing to your U.S. congressional representatives explaining this malfeasance that has been going on for decades and asking them to speak out for you and demand that CDC adopt the name myalgic encephalomyelitis and adopt the ICC or CCC criteria as well as that NIH fund the disease at $250 million a year.
Writing or sharing blogs about these facts (the government does pay attention to blogs!).
Tweeting links to this and other blogs to Francis Collins - @NIHdirector, Walter Koroshetz - @NINDSdirector, CDC - @CDCgov, Secretary of HHS, Tom Price - @SecPriceMD
MEadvocacy is a project of May12.org, whose mission is to “raise global awareness and education for Complex Immunological and Neurological Diseases (CIND).”
MEadvocacy continues our mission to get the name, myalgic encephalomyelitis, recognized in the U.S. as it has appeared and been coded for decades at the World Health Organization (WHO).
Things You can do for May 12:
Use a Profile Overlay: Change your social media profile page with a May awareness overlay for ME, FM, GWI, CLD, or MCS. See the easy instructions here.
Ask local and state officials to make a proclamation. See this FB page for samples https://www.facebook.com/groups/184652382049781/?ref=br_rs
Join the Thunderclap:https://www.thunderclap.it/projects/54427-it-s-may12th-awareness-day?locale=en
Light up the night by asking local venues to light up buildings and get light bulbs in the color for the disease you want to raise awareness for and display them for the month of May -https://www.facebook.com/events/1091121300980705/
May12.org recommends supporting the lobbying efforts and protest at the USDOJ by TruthCures at https://www.truthcures.org/activism - June 5-9, 2017 in Washington, D.C.
See list of all events for May 12th International Awareness Day document here and Facebook page here
By Frederick Dekkers (mechanical reproduction of 2D image) [Public domain], via Wikimedia Commons
Letter Confronting CDC's Continued Deaf Ear to the ME Community
Since the inception of MEadvocacy.org, we have fought against the systemic bias of demeaning patients and fraudulently misrepresenting myalgic encephalomyelitis (ME) at Health and Human Services (HHS), National Institute of Health (NIH) and Center for Disease Control (CDC).
Although, we had some reservations about sections of the letter such as the mention of the NAM (previously known as the IOM) report “Beyond ME/CFS: Redefining an Illness”, we have chosen to sign onto this letter because we agree with its core message of holding CDC accountable for the accuracy of all the information that appears on their website and on all their educational materials. We do not support using NAM definition in place of the experts ICC primer.
We are confident that the removal of the offending materials on the CDC website concerning CBT and GET treatments and psychogenic etiology, will have an immediate positive impact on the lives of all ME patients - from mild to severe , since it will aid in relieving suffering, improving conditions for patients, and reversing the continued disbelief in the medical community of the biomedical nature of this disease. These achievements fit into MEadvocacy’s mission.
Not All Criteria are the Same
Sometimes ME, as described by the ICC or Ramsay definitions, is inaccurately referenced as an alternate name to CFS (Fukuda criteria) and is found on the CDC website under CFS. The disease, myalgic encephalomyelitis, is not included on CDC’s list of diseases and using that term in the search engine box at the CDC website reroutes to CFS materials.
Using the ICC Primer
We would like to highlight that the letter asks that the ICC primer is also included in the educational materials/website. If you aren’t familiar with the International Consensus Criteria (ICC) please see our blog: THE INTERNATIONAL CONSENSUS CRITERIA What is it? Do I fit the criteria?
Past Requests to Address CBT and GET
CDC Ignores CFSAC
CDC Ignores Advocates
A year ago, November 19, 2015, MEadvocacy published the blog Tell HHS to Remove Flawed PACE Recommendations from Clinical Guidelines about our signing a letter along with other advocacy organizations calling for investigation into the flawed PACE trial and asked that the CDC remove all recommendations and risk and prognosis statements based on PACE and other Oxford studies from its current and planned medical education material. The reaction from the CDC was to ignore the request and continue with more of the same neglect of the ME patient population. The Agency for Healthcare Research and Quality (AHRQ) just downgraded recommendations for CBT and GET in the AHRQ Addendum once Oxford studies were excluded.
More History with CDC
In January 2016, the CDC approached MEadvocacy to join a working group to provide stakeholder input on CDC’s educational and informational materials which includes the CDC website. After receiving confirmation from Dr. Unger that the CDC work group’s scope was to advise on incorporating only NAM diagnostic criteria and that the CDC would not revise treatments, MEadvocacy opted out of the working group because we do not condone the use of overly broad criteria from the NAM report.
Read these blogs to learn more: MEadvocacy Opts Out of CDC’s Technical Development Workgroup and Further Correspondence with Dr. Unger at CDC from February 03, 2016.
Any bets on if CDC removes CBT and GET in their next website update expected sometime in 2017?
By Podknox, User:AlanM1 (Cropped from ) [CC BY 2.0
(http://creativecommons.org/licenses/by/2.0)], via Wikimedia Commons
How you can help counter the spread of the unscientific psychogenic illness model of ME:
Join MEadvocacy in supporting the UK ME community’s project Opposing MEGA (OMEGA) to counter efforts of researchers that promote the psychogenic bio-psycho-social model of ME.:
“A closer look at the MEGA petition reveals that key members and advisors of MEGA are involved in the discredited PACE trial, and the MAGENTA trial in children with ME/CFS which follows from the PACE trial, run by leaders of the bio-psycho-social (BPS) movement known collectively as 'The Wessely School'.
The BPS illness model of ME/CFS assumes that biological abnormalities and physical symptoms are caused or maintained by psychological or social problems and may be treated by changing the patient's thoughts and behaviours.” -- excerpt from petition
MEadvocacy.org has published two blogs regarding NIH’s invitation to Edward Shorter to speak at their NIH Clinical Center on November 9, 2016. Researchers, advocates and patients were opposed and fought this presentation because it would be used as propaganda to validate the unscientific psychosomatic view of myalgic encephalomyelitis (ME). See our blogs for more information: Systemic Bias Continues at NIH and Our Response to Dr. Koroshetz' Refusal to Cancel Lecture by ME Disease Denier.
Here is what Dr. Janet Dafoe, a clinical psychologist, shared on her FB post about her spouse Dr. Ron Davis, a world-renowned geneticist and ME/CFS researcher:
Despite the many letters to NINDS Director Walter Koroshetz demanding the cancellation of this presentation, it took place as scheduled with an audience that included personnel heavily involved in the ME clinical study. Shorter was actually introduced by the lead investigator of the clinical study, Dr. Brian Walitt.
Dr. Dafoe also shared on Twitter that Dr. Davis was advocating for a congressional investigation if Shorter’s lecture was not canceled.
It is a weak advocacy method to keep insisting on a “seat at the table” with the government when this “coveted seat” only serves to advance the government’s agenda. At times like this, when our demands are met by a brick wall, our advocacy methods need to take a new and different course.
We can then use our efforts to fight from the “outside” and seek collaborations with outside forces such as our congressional representatives. Falling for a false sense of inclusion is a dangerous course to take and will retain the status quo of NIH bias.
For deeper insight into the NIH bias, please read Gabby Klein’s blog at Relating to ME: Promises, Promises: Thirty Years of NIH Broken Promises
See bottom of blog for updates.
The myalgic encephalomyelitis (ME) community became aware November 3, 2016 that the U.S. National Institute of Health’s (NIH) ME/CFS Interest Group had scheduled a lecture, “Chronic Fatigue Syndrome in Historical Perspective,” by Edward Shorter, Ph.D. to take place on November 9, 2016 (see here for original event). This was discovered through Dr. Maureen Hanson’s tweet about the lecture to the community. Dr. Shorter is a professor of history and psychiatry who has been an open proponent of the misguided belief that myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a somatoform condition.
Shorter has written a book about psychosomatic disorders, From Paralysis to Fatigue -”a fascinating history of psychosomatic disorders shows how patients throughout the centuries have produced symptoms in tandem with the cultural shifts of the larger society. Newly popularized diseases such as "chronic fatigue syndrome" and "total allergy syndrome" are only the most recent examples of patients complaining of ailments that express the truths about the culture in which they live.” In addition, he has written various articles and comments on articles which spew the same lies about the organic neuroimmune disease, ME.
It is not surprising then, that ME patients and advocates became outraged at the fact that the NIH would choose a proponent of the psychosomatic view of the disease to lecture NIH researchers at the NIH Clinical Center about the history of the neuro immune disease ME. Patients and advocates immediately sent letters to the NIH ME/CFS representatives, expressing their shock and asking the NIH to cancel Shorter’s speaking engagement.
The following is the reply from Dr. Koroshetz to those who wrote in to complain:
Dear members of the ME/CFS community,
I appreciate the concern of many in the ME/CFS community as expressed in Ms. Spotila’s blog post concerning the visit and lecture by a Professor of the History of Medicine at the NIH intramural research program. It is important to understand the NIH’s commitment to reduce the burden of illness for people suffering with any illness regardless of its cause or its manifestations. In fact the study of one condition not infrequently leads to clues to the treatment of another in totally unpredicted ways. The exchange of information and widely divergent scientific opinions followed by critical analysis is essential to moving any field forward. Investigators at NIH regularly invite individuals to conversations about their areas of interest. This inclusion in scientific conversation is not an endorsement. Rigorously collected data that enables causal inference is the foundation of science. This remains the foundation of the NIH, and as stated from the start the NIH intramural investigators will focus on post-infectious ME/CFS in order to closely examine the clinical and biological characteristics of the disorder and improve our understanding of its cause and progression.
I hope that the ME/CFS community can endorse this scientific enterprise as we at NIH try to direct it to the problems faced by those who suffer with ME/CFS, both here at intramural research program and at universities and medical centers across the country. We know so little about the biological causes and nature of the disease that inclusivity of scientific thought will be critical to our success. At this point sadly we don’t know where the scientific enterprise will lead us, how long it will take, or from what area of research effective treatments will come.
The Professor mentioned in your letter was initially incorrectly listed as part of the ME/CFS Special Interest Group, which was corrected. The speakers that have come to the ME/CFS investigators are listed on the website at (http://mecfs.ctss.nih.gov/sig.html) and include:
June 15th, 2016: Anthony Komaroff, M.D.: An Overview of Chronic Fatigue Syndrome (ME/CFS)
July 18th, 2016: Leonard Jason, Ph.D.: Diagnostic Challenges and Case Definitions for CFS and ME
August 24th, 2016: Daniel Peterson, M.D.: CFS/ME: Perspectives from a Local Epidemic 1984-2016
September 21st, 2016: Staci Stevens, M.A. and Mark Van Ness, Ph.D.: Cardiopulmonary Exercise Testing in ME/CFS
Walter J. Koroshetz, M.D.
Director, National Institute of Neurological Disorders and Stroke
On behalf of the Trans-NIH ME/CFS Working Group
So, basically, what we hear Dr. Koroshetz is saying:
I hear your concern
Your thoughts are not important enough to change my mind
I think the belief that ME/CFS is somatoform constitutes a scientific enterprise
We don't have evidence that ME/CFS is biological
Science might lead us to the conclusion that it is just psychosomatic
- I hope you'll endorse my view
NIH, subsequently removed the event announcement of Dr. Shorter’s lecture sometime during the night of Nov. 3, 2016 or morning of Nov. 4th CST. Here is link to the NIH event page as it appeared on November 4, 2016 8:02:52 PM UTC.
To clarify, Koroshetz’ carefully worded his response attempted to side-step the complaint. He stated that Shorter was not part of the ME/CFS Special Interest Group and this would be corrected. The event announcement actually said that the ME/CFS Interest Group invited Shorter. It never said that he was part of the group. The event was announcing that Shorter's lecture was for NIH researchers, not that it was a meeting of Shorter and the group.
Dr. Koroshetz’ reply is not surprising. It is just more of the same dismissing the voice of the patient community and repudiation of the biological nature of the disease. After all, this is the same NIH that hires and continues to employ investigators like Drs. Brian Walitt, Fred Gill, and Leorey Saligan.
These NIH investigators all spew the same unscientific theory about ME patients - portraying that it is just the patients’ thoughts that make them think they are sick, that they are catastrophizing and attention seekers. These investigators’ hypothesis that psychosomatic diseases have an altering effect on biological processes is suspiciously similar to Shorter’s university bio webpage quote, “Melancholia as a distinctive illness in its own right, with characteristic biological markers.”
This is the same NIH that worked with the CDC to re-write the origin of the disease.
Step 1) Take a name (ME) and twist it (CFS) to imply it is not a disease but a symptom of fatigue rather than an acquired disease with immune abnormalities as seen in the Lake Tahoe outbreak. (See Osler’s Web by Hillary Johnson, and our ME science resource page).
Step 2) Define the disease with overly broad and faulty criteria so the psychologists/psychiatrists can now diagnose those with depression and somatoform disorders as CFS. NIH’s Dr. Straus and CDC’s Dr. Fukuda purposefully created the currently used Fukuda criteria so that those with somatoform disorders would fit under the CFS Fukuda criteria and be diagnosed as CFS. Thus muddying the cohort even further and resulting in confusing and unreliable research under the name CFS.
More alarmingly, these investigators were selected by NIH to work on the NIH ME/CFS Clinical Study. Dr. Walitt has been given the distinguished position of lead investigator! (see MEadvocacy.org's blog -NIH Sidesteps Critical Problems with the ME/CFS Study for details).
NIH director, Dr. Francis Collins, and Dr. Walter Koroshetz disregarded the protest by the ME patient and advocate community via petitions and letters demanding that these problematic investigators be removed from the NIH ME/CFS Clinical Study.
Additionally, the demand by ME patients and advocates to have input into the NIH study from the planning stage throughout all the steps of study have fallen on deaf ears as well. (The creation of small patient focus groups on specific subjects does not qualify for ongoing patient input from start to finish.)
The time has come for the ME community to face the facts of the dangers of the current NIH's leadership understanding and beliefs about ME. This is also why as outlined in MEadvocacy's blog, it is crucial to use the international experts' criteria [ICC]* to distinguish the neuro-immune disease ME, as opposed to the "fatiguing condition" as described by the other criteria.
Whereas, we do agree that NIH's invitation to Dr. Shorter to present a lecture at the NIH is inappropriate, damaging and should be canceled, it pales against the harm to ME patients from the ongoing employment of problematic investigators at the NIH and their assignment to the NIH ME/CFS Clinical Study.
It is clear that without congressional intervention this malfeasance will continue unhindered. The ME community needs to testify to congress about this ongoing malfeasance and medical harm to their constituents. A congressional hearing may be the only way our voices will get heard.
WHAT YOU CAN DO:
Contact your members of congress and tell them:
NIH continues to ignore ME patients’ pleas for biomedical research into disease
We need funding of at least $250 million per year for research into ME
Consider a congressional hearing to find out why ME and other similar patient communities like Fibromyalgia, Gulf War Illness, and Chronic Lyme patients are being mistreated
Sign petition at Change.org: “Calling for a Congressional investigation of the CDC, IDSA and ALDF”
Volunteer for MEadvocacy by contacting us at MEadvocacyorg@gmail.com
Special thanks to independent advocate and MEadvocacy volunteer, Gabby Klein, for co-writing this blog with the advisory committee.
Blog mentioned in Dr. Koroshetz's response: An Open Letter to Dr. Koroshetz by Jennie Spotila
Blog Post-Publication Additions:
* In addition to the ICC criteria, expert advocates also support use of Ramsay’s ME definition due to its development based on patients in epidemic cohorts. (Added as if as of Nov. 8, 2016)
Here are additional patient/advocate letters in regards to protesting Dr. Shorter’s lecture at the NIH Clinical Center:
MEadvocacy.org Advisory Committee & patient advocate Gabby Klein Letter to Koroshetz:
http://www.meadvocacy.org/our_response_to_dr_koroshetz_refusal_to_cancel_lecture_by_me_disease_denier (Added as if as of Nov. 8, 2016)
Deborah Waroff’s Letters:
https://www.facebook.com/groups/1471389426411574/1791756414374872/?notif_t=group_activity¬if_id=1478544573418660 (Added as if as of Nov. 8, 2016)
Nancy Blake’s Letter to Koroshetz:
https://www.facebook.com/nancy.blake.9803/posts/10209696691087077 (Added as if as of Nov. 8, 2016)
Tina Tidmore’s Letter to Koroshetz:
http://mecfsfromme.blogspot.ca/2016/11/its-not-scandal-its-cover-up.html?m=1 (Added as if as of Nov. 8, 2016)
This letter is in reply to Dr. Koroshetz letter of Nov 4, 2016 to the ME/CFS community refusing to cancel the invitation by NIH of a lecture to NIH investigators titled: “Chronic fatigue Syndrome in Historical Perspective”.
Dear Dr. Koroshetz,
Thank you for your time in replying to the ME/CFS community regarding our objection to NIH's invitation to Dr. Edward Shorter to lecture on "a historical perspective on CFS". In your letter, you ask the community to endorse "the scientific enterprise" of Dr. Shorter's viewpoint about ME/CFS (that it is a somatoform condition). You assert: "We know so little about the biological causes and nature of the disease that inclusivity of scientific thought will be critical to our success."
Let us explain why not only will the community refuse to endorse Dr. Shorter as an educator about ME/CFS but will object to anyone at NIH who profess the same lies about a disease that has an infectious onset with evidence (over 5,000 published papers) of biological, neurological, muscle, immune, ATP, metabolomic, mitochondrial, gut and autonomic abnormalities.
The role of any medical doctor is to "first do no harm". The lazy dogma that ME/CFS is a somatoform condition has harmed millions of patients for the past thirty years. This corruption started following the Lake Tahoe outbreak - when the CDC dismissed biological evidence found there and started a spiral of steps in order to cover-up the real evidence. This whitewashing was accomplished with the machination of a trivial "fatigue" name (chronic fatigue syndrome) and government constructed overly broad and false criteria.
This burial in the sand of the real facts and evidence of the biological disease myalgic encephalomyelitis still continues today at the CDC and the NIH with the following:
Refusal to adopt and exclusively use the authentic name for the disease - myalgic encephalomyelitis (ME)
Rejection of the experts' criteria for the disease (CCC, ICC, Ramsay's) in favor of the government constructed faulty criteria (Oxford, Fukuda, IOM)
Disdain toward any recommendation for input in the government process regarding ME/CFS by the patient and advocate community (ignoring CFSAC recommendations; refusing input from start to end in the NIH ME/CFS Clinical Study; preserving faulty information on government websites, educational materials and continuing professional education and many more requests including the current Dr. Shorter issue)
Employing NIH investigators with the same false illness beliefs about ME/CFS as Dr. Shorter's (somatoform, catastrophizing) and appointing them to the current NIH ME/CFS Clinical Study while ignoring the outcry from the patient and advocate community (Drs. Walitt, Gill and Saligan - see blog NIH Sidesteps Critical problems with the ME/CFS Study).
Suppressing adequate and equitable NIH funding for the past 30 years resulting in the prolonged suffering and early deaths of millions of ME patients ($250 million a year is the minimum amount ME/CFS should be getting - equitably, it should be $2 billion a year)
It is evident that this malfeasance has been and continues to be the pattern with CDC and NIH. It is obviously a profitable enterprise for NIH to be able to "fit" as many conditions as possible under the so-called “Conversion Disorder” (Functional Neurological Symptom Disorder) and “Somatic Symptom Disorder” (SSD) diagnostic codes. This would absolve NIH from further funding biological studies for these diseases. Your decision that Shorter could add value to NIH's understanding of ME/CFS is not only unscientific and self-serving but, an insult and dangerous to every ME patient.
There is historical evidence of many harms to humans performed in the name of "scientific advancement". On which side will NIH stand when the day of reckoning will come regarding the harm perpetrated by the US government health agencies toward the ME patient community?
MEadvocacy.org Advisory Committee:
Colleen Steckel, Joni Comstock, and Tracey Smith
Relatingtome.net - patient advocate and blogger:
Revised November 14, 2016 to include steps to evaluate for atypical ME as defined by ICC.
MEadvocacy.org understands there is a great deal of confusion about the various criteria for myalgic encephalomyelitis, so we created an easy to follow questionnaire to help patients see if they may fit the 2011 International Consensus Criteria.
Do I fit the International Consensus Criteria?
Questionnaire for patients over age 18
Disclaimer: This questionnaire does not replace the full International Consensus Criteria (ICC) document or the primer. It is based on the symptoms of the criteria and should not be used as a substitute for medical advice from a licensed medical professional. This document is for informational purposes. Consult a physician experienced in diagnosing ME. It is important to evaluate for other diseases before assigning a diagnosis of ME (ICD code G93.3).
According to the ICC a six month waiting period is NOT required for diagnosis of ME. Removing the waiting period is very important so ME patients can be advised to get complete rest as soon as possible in order to get the best possibility of improved health.
Must have Post Exertional Neuroimmune Exhaustion (PENE)
PENE is physical inability to produce sufficient energy on demand.
The following are signs you have PENE:
Marked, rapid physical and/or cognitive fatigability in response to exertion, which may be minimal such as activities of daily living or simple mental tasks, can be debilitating and cause a relapse.
Post-exertional symptom exacerbation: such as acute flu-like symptoms, pain and worsening of other symptoms
Post-exertional exhaustion: may occur immediately after activity or be delayed by hours or days
Recovery period is prolonged, usually taking 24 hours or longer. A relapse can last days, weeks or longer
Low threshold of physical and mental fatigability (lack of stamina) results in a substantial reduction in pre-illness activity level.
Symptom severity must result in a significant reduction of pre-illness activity level.
The 2 day Cardio Pulmonary Exercise Test available at Workwell Foundation (California) and Ithaca College (New York) is a 2 day CPET specifically designed to look for inability to repeat physical activity two days in a row.
If you aren’t sure if you have PENE, watching the following video may help you answer the question.
Video by Mark VanNess explaining an abnormal physiological response to exertion and the 2 day test: https://www.youtube.com/watch?v=FXN6f53ba6k&app=desktop
Do you have PENE: ___ Yes ___No
If YES, go to next section.
If NO, stop quiz. You do not fit criteria.
Check off the ones that apply to you.
- ____ Difficulty processing information: slowed thought, impaired concentration such as confusion, disorientation, cognitive overload, difficulty with making decisions, slowed speech, acquired or exertional dyslexia
____ Short-term memory loss: difficulty remembering what one wanted to say, what one was saying, retrieving words, recalling information, poor working memory
____ Headaches: such as chronic, generalized headaches often involve aching of the eyes, behind the eyes or back of the head that may be associated with cervical muscle tension; migraine; tension headaches
____ Significant pain can be experienced in muscles, muscle-tendon junctions, joints, abdomen or chest. It is non inflammatory in nature and often migrates. In other words have generalized hyperalgesia, widespread pain (may meet fibromyalgia criteria), myofascial or radiating pain.
Hyperalgesia: increased sensitivity to pain
Myofascial: pertaining to a muscle and its sheath of connective tissue, or fascia
____ Disturbed sleep patterns: such as insomnia, prolonged sleep including naps, sleeping most of the day and being awake most of the night, frequent awakenings, waking much earlier than before illness onset, vivid dreams/nightmares
____ Unrefreshed sleep: awaken feeling exhausted regardless of duration of sleep, day-time sleepiness
Neurosensory, perceptual and motor disturbances
____ Neurosensory and perception: inability to focus vision, sensitivity to light, noise, vibration, odor, taste and touch; impaired depth perception
____ Motor: muscle weakness, twitching, poor coordination, feeling unsteady on feet, ataxia
Ataxia: Inability to coordinate muscle activity
Did you check at least one box in at least three categories in section 2? __ Yes __ No
If YES, go to next section.
If NO, continue for possible atypical ME criteria.
Check off the areas that apply to you.
____ Flu-like symptoms may be recurrent or chronic and typically activate or worsen with exertion. Such as sore throat, sinusitis, cervical and/or axillary lymph nodes may enlarge or be tender
____ Susceptibility to viral infections with prolonged recovery periods
____ Gastro-intestinal tract: such as nausea, abdominal pain, bloating, irritable bowel syndrome
____ Genitourinary: such as urinary urgency or frequency, excessive urination at night
____ Sensitivities to food, medications, odors or chemicals
Did you check at least three boxes in section 3? ___ Yes ___ No
If YES, go to next question.
If NO, continue for possible atypical ME criteria.
Check off the ones that apply to you:
____ Cardiovascular - inability to tolerate an upright position - orthostatic intolerance, neurally mediated hypotension, postural orthostatic tachycardia syndrome, palpitations with or without cardiac arrhythmias, light-headedness/dizziness
____ Respiratory - air hunger, laboured breathing, fatigue of chest wall muscles
____ Loss of thermostatic stability - subnormal body temperature, marked diurnal fluctuations; sweating episodes, recurrent feelings of feverishness with or without low grade fever, cold extremities
____ Intolerance of extremes of temperature
Did you check at least one box in section 4? ___Yes ___ No
If NO, continue for possible atypical ME criteria.
If you have answered YES to each section, you fit the
International Consensus Criteria for Myalgic Encephalomyelitis.
If you answered no in section 2, 3, or 4 you may have atypical ME.
Myalgic encephalomyelitis International Consensus Criteria Authors: B. M. Carruthers, M. I. van de Sande, K. L. De Meirleir, N. G. Klimas, G. Broderick, T. Mitchell, D. Staines, A. C. P. Powles, N. Speight, R. Vallings, L. Bateman, B. Baumgarten-Austrheim, D. S. Bell, N. Carlo-Stella, J. Chia, A. Darragh, D. Jo, D. Lewis, A. R. Light, S. Marshall-Gradisnik, I. Mena, J. A. Mikovits, K. Miwa, M. Murovska, M. L. Pall, S. Stevens
Note: pediatric symptoms vary - See source at this link for pediatric: http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
Link to the International Consensus Primer for Physicians which lists tests and treatment options for those who fit the ICC: http://sacfs.asn.au/download/me_international_consensus_primer_for_medical_practitioners.pdf
Here is a link to the Questionnaire if you would prefer to print it out.
WHAT CAN YOU DO?
To better understand the various criteria used for ME. and CFS, please read our blog, Analysis of CFSAC August 2015 Recommendations for the IOM Criteria, from Dec 2015: http://www.meadvocacy.org/analysis_of_cfsac_august_2015_recommendations_for_the_iom_criteria
Help us educate patients so they can become their own advocate by sharing/liking this blog on social media platforms; liking/and or sharing the MEadvocacy facebook page posts; and liking/retweeting MEadvocacy tweets.
It is with very heavy hearts that we report the passing of our friend and fellow ME advocate, Tom Jarrett.
Tom came to MEadvocacy in the fall of 2014 looking for help with a protest against the Pathways to Prevention Workshop (P2P) at the National Institutes of Health (NIH). Despite being in constant pain and needing to lay in a zero gravity recliner, Tom organized on very short notice an awareness event, traveling 10+ hours to protest at the NIH, with himself, church and family members, including his wife and two young boys, in attendance. It was a very cold winter day. A cameraman from the documentary, “Canary in a Coalmine” stopped by to film.Read more
The MEadvocacy Advisory Committee is taking a well deserved break for the summer. See you in the fall.
As you may know, the general public, medical professionals and politicians are mostly unaware of the prevalence and severity of myalgic encephalomyelitis (ME) in the U.S. and around the world.
A visual representation can have more impact than words or numbers, or as a wise person once said “A picture is worth a thousand words”.
A visual map representing the thousands and thousands of ME patients in every nation, state, city and voting district can be used to show how many of a politician’s constituents are affected, and hopefully spur them to action on our behalf.
Each year the Senate and House appropriations committees take submissions for planning the federal budget and expenditures. This includes funding for federal disease research. This spring, MEadvocacy once again sent in submissions outlining the devastating nature of myalgic encephalomyelitis (ME) and the need for research.Read more
Guest blog by Maryann Spurgin, Ph.D.
"An idea is always a generalization, and generalization is a property of thinking.
To generalize means to think."
~ Georg Wilhelm Friedrich Hegel
“As the biggest library if it is in disorder is not as useful as a small but well-arranged one, so you may accumulate a vast amount of knowledge but it will be of far less value than a much smaller amount if you have not thought it over for yourself.”
"Out-of-date theories are not in principle unscientific because they have been discarded."
~Thomas S. Kuhn, The Structure of Scientific Revolutions
"We see the world in terms of our theories."
~Thomas S. Kuhn
Note: I wrote this proposal in the late Fall of 2015 and in early 2016 as a work proposal (Circulatory Impairment in Myalgic Encephalomyelitis: A Work Proposal —by Maryann Spurgin, Ph.D. January 16, 2016
In mid January I began sending it to medical schools, and in late January/early February, I sent an earlier, longer version to some privately funded research teams, including to Ron Davis. Very recently, on May 27, 2016, I sent it to the research team at NIH at the following email addresses:Read more
May 18, 2016
Good afternoon to the Advisory Committee Members and to all stakeholders listening.
My name is Eileen Holderman - I'm an advocate for ME, GWI and other neuroimmune diseases.
Recently, I served as consultant to MEadvocacy, an organization advocating on behalf of nearly 1 million American men, women and children suffering from Myalgic Encephalomyelitis (ME).Read more
Why We Need to Raise Awareness
Disease sufferers have different ways they try to raise awareness of their plight. This is often done by distinct colored ribbons and assigned months when events and activities are geared toward raising awareness for that particular disease.
Myalgic encephalomyelitis (ME) uses the color blue for the awareness ribbon and the month of May has been assigned as the month of awareness. All patients suffering from any illness have dire needs for attention, whether for funding for research or for proper care and treatment. ME patients, because of the history of neglect and malfeasance by the government health agencies, have the added responsibility to testify about their personal stories and about the dismal history of medical abuse.Read more
May is awareness month for the related complex immunologic and neurologic diseases (CIND):
ME, CFS, Lyme, GWI, FM and MCS.
May 12 is the specific date chosen to raise awareness for these diseases, because it’s Florence Nightingale’s birthday. After her groundbreaking work in nursing, Nightingale became bedridden for decades from a mysterious disease similar to ME.
This year, May12.org has developed an easy way to spread awareness across social media with a May awareness overlay for your Facebook, Twitter or other social media profile photo.Read more
Guest Blog submitted by the ME Global Chronicle staff
MUPS (Medically Unexplained Physical Symptoms)
This is a guest post by ME Global Chronicle, a bi-monthly international online magazine, covering news on myalgic encephalomyelitis from all over the world. They are currently featuring a petition to the Dutch Health Council calling for the replacement of panel members to a government advisory committee who have a psychogenic bias of the disease.