Today, ME advocates Eileen Holderman and Gabby Klein sent an open letter to the Secretary of the U.S. Department of Health and Human Services (HHS), Alex M. Azar II. The letter urges Secretary Azar to implement the International Consensus Criteria (ICC), disseminate the International Consensus Primer (IC Primer), use the name Myalgic Encephalomyelitis and to stop the campaign to implement, disseminate and code systemic exertion intolerance disease (SEID).
Please email, phone or visit your congressional representatives and urge them to contact Secretary Azar to implement the ICC, disseminate the IC Primer, use the name Myalgic Encephalomyelitis and stop the campaign to implement, disseminate and code SEID. When you contact your Congressman briefly explain how Myalgic Encephalomyelitis has impacted your life and use the open letter as your talking points for your asks.
We encourage everyone in the ME community to sign the People with ME for ICC (#pwME4ICC) petition to HHS urging the implementation of the ICC, dissemination of the IC Primer and the use of the name Myalgic Encephalomyelitis. After signing the petition, please share and promote it on Facebook and Twitter.
Organization Call to Action
Please become a member of or volunteer for the organization MEadvocacy and support their efforts to advocate for proper criteria and name (ME-ICC).
Twitter Call to Action
Join the Twitter initiative #TeamTweetStorm to promote the ICC, the IC Primer for ME and to stop the government’s campaign to bury ME with their new criteria SEID. After you join Twitter, follow Eileen Holderman @TurnItUp4ME and Gabby Klein @GabbyKlein1 to participate in our ongoing Twitter initiative.
A man dies when he refuses to stand up for that which is right. A man dies when he refuses to stand up for justice. A man dies when he refuses to take a stand for that which is true. – Martin Luther King, Jr.
My thanks to advocate Eileen Holderman for her consultation on this blog post
Fake Media Attacks on #PwME
In the past week, there has been a media onslaught of biased and stinging articles maligning 17 million disabled men, women and children worldwide who suffer from the acquired neurological and immunological disease myalgic encephalomyelitis (ME). The false media stories about the disease betray the ample scientific evidence that this is an acquired, infectious, biologically based disease which appears in the outbreak (50+ worldwide) and a sporadic form.
For decades the biopsychosocial (BPS) UK force, led and assisted by the US Centers for Disease and Control (CDC) hijacked a biological disease and falsely depicted it with their false BPS indoctrination. The seeds were planted decades ago by CDC, and BPS proponents worldwide jumped on the bandwagon. Powerful forces whether in the insurance industry or government health agencies have a financial stake in making this disease disappear. With their science denialism, they are saving massive amounts of money by withholding medical testing, treatments, research and disability payments.
In 2011, the costly UK PACE Trial recommending GET and CBT as treatments for “CFS” was published. It was met by severe criticism from the medical, scientific, advocacy and patient communities for the poor use of cohort selection (Oxford Criteria), faulty study design, changing protocol midway – including criteria and outcome measures. Recently, the UK BPS propagandists’ trophy, the PACE Trial, has been experiencing a blitz of increased criticism from scientists, academics, and advocates – discrediting the study for its poor design and unreliable findings. To save embarrassment for their failed study, UK BPS promoters are instead deviously accusing the victims (17 million severely disabled people) with the crime of daring to complain about being forced to take harmful bogus treatments – treatments which ME experts agree in consensus are harmful to people with ME.
In the Reuters’ article Special Report: Online activists are silencing us, scientists say, the author writes a one-sided, distorted piece which not only tells the BPS slant but attempts to legitimatize the false narrative that ME is just an ailment of the mind. The facts, that over 10,000 scientific papers have been published showing biological abnormalities and that nearly 100 ME clinicians, researchers, and academics signed a letter in opposition of the PACE trial and its findings, were purposefully left out of the piece.
And of course, just like earthworms who mysteriously appear after an intense rain, other media outlets published articles this week with the same insulting and shameful propaganda. I’m not surprised by this. It’s the BPS proponents’ last major lost battle cry!
Victim blaming and falsely defaming a group of advocates are classical silencing methods which I wrote extensively about in my blog: “Resisting Attempts to Silence #PwME.” This well-known manipulation method is reprehensible but, when directed at a vulnerable, very ill patient community, it is particularly cruel and shameful.
Reuters Quotes CDC’s Dr. Unger
The Reuters piece quotes CDC’s Dr. Elizabeth Unger who reveals CDC’s true colors when it comes to GET and CBT. The article states:
The head of the CDC’s chronic viral diseases branch, Elizabeth Unger, told Reuters this [the removal of GET & CBT terms] was done to remove jargon and medical terms that are not widely understood by the public. “We received feedback that the terms were confusing and too frequently misinterpreted,” she said in an email response to questions.
Unger said the CDC’s advice stresses that each CFS/ME patient’s needs are different. “For some, carefully managing exercise and activities can be helpful,” she said. “Likewise, some patients may find that talking with a therapist helps them.”
Dr. Unger could have used this opportunity to condemn GET and CBT as harmful to patients with ME but, chose not to. Instead, Unger claims that CDC removed the labels of these therapies because it was “confusing” and frequently “misinterpreted”!
What she goes on to recommend sure sounds like CBT and GET!
The organization MEadvocacy.org and independent ME advocates have been strong proponents in pointing out that CDC’s claims of an improved website are not that at all. They just removed some trigger labels yet, the message is the same old (see my blog – Emperor CDC’s New Clothes).
CDC’s Ongoing Malfeasance
In the US, for over three decades the CDC with intent and malice took measures to bury the disease ME. They did this by controlling the narrative of the disease. They consistently refuse to acknowledge that this is an infectious disease which appears in outbreaks and refuses to adopt the criteria created by international ME experts – the International Consensus Criteria (ICC). Instead, they repeatedly re-define the disease with overly broad meaningless definitions.
CDC’s leadership decided from the start that they were going to bury the distinct disease ME. Their malfeasance was revealed through an FOIA request by advocate Craig Maupin. Craig obtained a copy of a letter written by Stephen Straus (NIAID) to Keiji Fukuda (CDC) after he authored the 1994 Fukuda criteria.
Straus writes:
Now that the definition is revised we could project at leisure what will come of it. I’d be very interested in your frank opinion on the matter when convenient. My own sense is that a few years of use in the field will once again verify that there is no demonstrable or reproducible differences between individuals who meet the full CFS criteria and those who can be said to suffer Idiopathic Chronic Fatigue. This would beg the question of whether additional revisions to the definition are warranted, or its entire abandonment.
I’ve felt for some time, Kieji, that those that have CFS are at a certain point along a continuum of illness in which fatigue is either the most dominant symptom or the most clearly articulated by virtue of impression on the part of the patient or physician that such a complaint is important. I predict that fatigue itself will remain the subject of considerable interest but the notion of a discrete form of fatiguing illness will evaporate. We would then, be left with Chronic Fatigue that can be distinguished as Idiopathic or Secondary to an identifiable medical or psychiatric disorder. I consider this a desirable outcome.
The desired outcome – the evaporation of the disease!
Timeline of CDC’s Burial of ME Through the Creation of Inappropriate Names and Overly Broad Definitions
In 1988 – CDC created the Holmes Criteria. The CDC’s definition emphasized “fatigue” and required 8 out of 11 symptoms for diagnosis with no explicit exclusion for all [edited to add “all” 3/22/19] psychiatric conditions. This is also when the demeaning moniker “chronic fatigue syndrome” was stamped on us, creating the false narrative that people with ME are just lazy and choose to complain about a common complaint of fatigue.
In 1994 – CDC redefined the disease using the Fukuda Criteria. This time, CDC engaged the aid of BPS proponents – Michael Sharpe, Simon Wessely, Andrew Lloyd, and Ian Hickie in writing this watered down definition. The new definition reduced the number of symptoms required for diagnosis to only 4 out of 8. The stress was still on fatigue, and the hallmark symptom post-exertional malaise (PEM) was not required (only optional).
In 2005 – CDC created the Reeves Criteria (also called the Empirical definition). The authors, William Reeves, Elizabeth Unger, and Suzanne Vernon also promoted the Reeves’ self-reported questionnaires which were all about subjective feelings of fatigue. This latest definition was so broad (basically if you had long term fatigue, you received a diagnosis of “CFS”) that it substantially (and falsely) increased the prevalence of the disease.
CDC’s Ongoing BPS Propaganda with the Creation of the Toolkit
On November 3, 2006, the CDC launched its toolkit for health care professionals at the National Press Club Conference. The toolkit, which Kim McCleary of the CFIDS Association of America (now called Solve ME/CFS Initiative) helped write, features and details recommendations for graded exercise therapy (GET) and cognitive behavior therapy.
Dr. Anthony Komaroff who spoke at the conference stated: “But the good news is that there are now over 4,000 published studies that show underlying biological abnormalities in patients with this illness. It’s not an illness that people can simply imagine that they have and it’s not a psychological illness. In my view, that debate, which was waged for 20 years, should now be over.” (This – nine years before the IOM Report was published)
Yet, perversely, almost the entire CDC toolkit is about psychological treatments for “CFS” such as GET and CBT. It talks about coping methods and emotional issues. CDC’s toolkit for clinicians was featured on the CDC’s ME/CFS website as well as tens of thousands of hard copies that were sent out to medical practitioners nationwide. It was also translated and disseminated into Spanish.
CDC has tentacles all over the world and after the media presentation, the CDC toolkit started to appear on medical websites all over the world causing clinicians in different countries to spread the abuse. Additionally, CDC’s toolkit linked to London’s St. Bart’s Hospital where Psychiatry professor Peter White worked and propagated the BPS misinformation.
To this date, CDC has not officially retracted the toolkit nor have they issued a black-box warning against using GET and CBT for pwME.
CDC’s Latest Attempt at Entombing ME with the IOM Criteria and SEID Name
Against the urging of the medical, research, advocate and patient communities, CDC contracted – for a million dollars – with the Institute of Medicine (IOM) (now called National Academy of Medicine (NAM)) to redefine the disease yet again. This was in direct violation of the recommendation of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), doctors, researchers, ME advocates, and patients. ME clinicians, researchers, and advocates wrote open letters (experts’ open letter and advocates open letter) to HHS urging them to cancel the IOM contract and instead adopt our ME experts criteria (the Canadian Consensus Criteria (CCC) with the aim of working toward the adoption of the International Consensus Criteria (ICC)).
CDC refused to adopt and use our experts’ criteria because it would mean relinquishing their hold on the puppets spewing the false BPS narrative of the disease and admitting to the actual reality of the biological disease ME.
In 2015, the IOM authors delivered their report. They complied with CDC’s wishes and created another overly broad definition with a small checklist of 4 out of 5 common subjective symptoms. The IOM authors did not specify any specific testing to aid in diagnosis (the ICC does) and, most importantly, no psychiatric exclusions are required. This will result in many people, some with psychiatric disorders, to be misdiagnosed and muddy the waters. Not only did the IOM authors deliver, per CDC’s directive, a loose meaningless definition but, they also recommended a new absurd name – systemic exertion intolerance disease (SEID).
MEadvocacy.org and ME advocates have repeatedly informed the community about CDC’s ongoing malfeasance and how this will continue to adversely affect people with ME worldwide. Since the 1980’s CDC’s stronghold and perversion of the narrative of the disease have driven the lack of large scale serious biological studies, proper medical care, appropriate medical testing, and promising FDA approved treatments. They used methods to accomplish their aim of burying ME by redefining the disease over and over again and really blurring the line whether this is a biological or psychosomatic disease. CDC engaged the aid of UK BPS proponents to help carry out their harmful recommendations, and they continue on this contemptible path.
The media outlets have jumped on all this misinformation and have caused untold harm to people with ME by misrepresenting the disease and by mischaracterizing pwME as lazy malingerers.
CDC remains the puppeteer – still pulling the BPS strings worldwide!
My thanks to advocate Eileen Holderman for her consultation on this blog post
The US government health agencies and some organizations who purport to represent people with ME (pwME) are deceiving this community by purposefully conflating names and criteria for myalgic encephalomyelitis (ME), and the government constructs chronic fatigue syndrome (CFS) and systemic exertion intolerance disease (SEID). These organizations are complicit with carrying out the government’s nefarious actions in burying a severe neurological disease, ME, which has killed and rendered hundreds of thousands of Americans severely disabled for many decades.
HHS is Adopting SEID Criteria While Cloaking with ME Name
In defiance of ME stakeholders, the Chronic Fatigue Syndrome Advisory Committee (CFSAC), ME expert doctors and researchers, advocates, and patients, the U.S. Department of Health and Human Services (HHS) has consistently refused to adopt the name myalgic encephalomyelitis with its definition created by ME experts (the latest one being the International Consensus Criteria (ICC)) for the distinct disease. HHS admits that the disease ME, as classified by the World Health Organization (WHO) as a neurological disease since 1969, exists as distinctive and unequal to CFS and SEID, yet they refuse to formally recognize it, adopt its proper name and criteria, fund it and educate about it.
Why would HHS state that ME exists yet deny care for the people suffering from the disease? There is no question that since the 1980’s there has been an HHS agency-wide effort to cover up facts about ME, including the dozens of outbreaks of ME worldwide. Once they have started on the path of erasing history, HHS cannot politically afford to change course. Unless exposed publically or challenged legally, HHS will not admit to their malfeasance of attempting to erase a disease and therefore they keep inventing new vague umbrella entities with demeaning names to cover up their wrongful actions.
Organizations Are Adopting SEID Criteria While Cloaking it with ME Name
Some organizations purport to advocate for pwME yet, deceptively, aid the government with the creation, promotion, and dissemination of faulty definitions (SEID being the latest one) and with the conflation and misusing of names. Ironically, they falsely label themselves as ME organizations when in fact they do not advocate for the disease myalgic encephalomyelitis.
These organizations get preferential treatment from the government for their partnership with them. They get funding for research projects and are rewarded with a seat at the government table. They are selected to serve on government working groups where they are in place to advise the government on policy decisions. The government also partners with film production companies or organizations to show screenings of their film.
Additionally, HHS arranges private meetings with these organizations where they can meet with high-level government officials. For example, Dr. Lily Chu, vice president of the IACFSME organization, consulted privately with Donna Pickett of NCHS/CDC (the National Center for Health Statistics – the agency is overseen by the CDC and is in charge of coding) to work on proposals for changes to US ICD coding.
Their consultation led to a presentation of their proposal in a public meeting on September 12, 2018. This ‘public’ meeting was unannounced to the rest of the “public”. Therefore, Dr. Chu was able to call in her comments and endorsement of a harmful, unscientific proposal without any challenge from the rest of the community. Sneaky much?
Classifying SEID as if Equal to ME
According to Donna Pickett of NCHS/CDC and Dr. Chu, all HHS agencies have currently adopted the untested SEID. At the same time, HHS is using the combination acronym ME/CFS – when in fact SEID is not ME nor is it CFS (this was clarified in the 2015 IOM report)!
The nomenclature deception is purposeful and really serves to confuse and conflate everything into a chaotic mess where names and definitions have lost all meaning. The government’s hope is that by the wrongful use of the ME/CFS acronym, it will lull pwME into thinking that ME is being included – when in fact it is the farthest thing from the truth.
Listen to Dr. Lily Chu state in her call-in comment at the September 12, 2018, C & M meeting that all HHS agencies have currently adopted and are using SEID.
The current attempt by IACFSME/Chu to elevate SEID by classifying it in the US ICD-10-CM under the same heading as ME – as if it is an equal neurological disease – when clearly it is not – is disturbing and dangerous because it will result in the disappearance of ME! (read blog NCHS/CDC Proposal for ICD-10-CM). Other countries should pay attention because whatever happens in the US usually is followed by other countries.
The organization MEadvocacy who has never wavered from their mission to advocate for the disease ME as defined by ME experts has taken action and submitted comments to object to the NCHS/CDC and IACFSME/Chu proposal. You can read about their submitted comments here.
Solve ME/CFS Initiative was repeatedly asked by longtime independent ME advocate and past CFSAC voting member, Eileen Holderman, on Twitter what Solve’s response to the dangerous ICD-10-CM proposal was. It was first met with silence, then with a curt reply. Eventually, Solve sent out this video featuring their CEO, Carol Head.
In this 3 minute video, Carol Head states: “We work with the CDC regarding ICD coding.” Does SMCI work with CDC behind our backs in secrecy? Did SMCI help write the current proposal for SEID to be classified with ME? We don’t know because there is no transparency in Solve’s actions and they have, to this date, not made an official statement nor revealed if they are submitting comments about NCHS’s proposal for changes to the ICD coding.
*Please note – Finally yesterday Solve ME/CFS Initiative released a policy statement where they openly admit to endorsing the IOM report. The deception and conflation continue and their statement changes nothing written in this blog.
Organizations Hidden Dissemination of SEID
MEAction, Solve ME/CFS Initiative, and Massachusetts ME/CFS & FM Association helped draft a US Senate Resolution for “ME/CFS” featuring the IOM report and its recommendations for the name SEID and the IOM criteria (read the blog Beware of Aiding in the Burial of ME!). When confronted with this betrayal, MEAction issued a clarification on June 28, 2018, deflecting blame and attributing it to confusing language (as of this date, the same language still stands).
Additionally, MEAction in partnership with #Time for Unrest has created an accredited course for continuing medical education to teach doctors how to diagnose SEID. Their course, deceptively titled Diagnosis & management of myalgic encephalomyelitis, is actually teaching doctors how to diagnose patients using the actual IOM criteria verbatim.
When ME advocates asked Jen Brea on twitter to explain this disparity, her reply was this:
When I further challenged Brea stating that MEAction is currently using IOM/SEID criteria in their educational packets to medical professionals. This was her reply:
So-Called ME Organizations Who Do Not Support ME Experts’ Criteria
I asked MEAction to endorse and promote the #pwME4ICC petition to HHS to recognize and adopt ME as defined by the experts’ criteria – ICC. They countered that they will share it once on social media but could not sign and endorse it because their organization had not come to a decision yet as to which clinical criteria they chose to endorse.
So, MEAction would not sign nor endorse ME-ICC petition, yet they gladly created a curriculum for an accredited continuing education course for medical professionals using IOM/SEID! To endorse the experts’ ME-ICC they need to go through a “community consultation” for which the timeline keeps being delayed but, to endorse and disseminate HHS/IOM’s SEID, they don’t need community approval?
I also approached Solve ME/CFS Initiative asking them to sign and share the petition to HHS for recognition of ME as defined by ICC. They promised to look into it. Three months later Solve has still not replied and have not signed or promoted the ME-ICC petition.
Why This is Important
The topic of which definition is being used for clinical and research purposes as well as correct naming is probably the most critical issue for those representing and advocating for pwME.
The distinct disease myalgic encephalomyelitis as per WHO and experts’ criteria (ICC) is in danger of being totally erased. If you suffer from ME, you will not get a proper diagnosis. Doctors in the US will only know how to diagnose SEID and will give you a SEID ICD code – even though SEID is a definition based on fatigue and 5 subjective common symptoms (with no exclusions for psychiatric conditions).
The definition of ME as per ICC is not a fatigue condition; it is rather a neuro-immune disease with most probably an infectious component. If you are diagnosed with SEID you will not get the proper testing, care, and treatments that would have been geared to a diagnosis of ME.
More disturbingly, IOM/SEID is already being used for research purposes even though the IOM was charged with creating a clinical definition. Some of the new NIH research consortia are using cohorts provided by Dr. Bateman from her clinical practice which have been diagnosed using the IOM/SEID definition.
How to Fight the Disappearing of ME
PwME need to demand change on a federal level. They can do this by joining the 5,178 people who have signed the petition so far to HHS for recognition of ME as defined by our experts’ criteria – the International Consensus Criteria (ICC). They should contact their congressional representatives telling them to press HHS to officially acknowledge their disease ME as defined by ME experts’ criteria – ICC.
PwME should also demand transparency and truthfulness from the organizations that purport to advocate for pwME. PwME should not be left in the dark about what these organizations are planning and supporting. If they are supporting SEID, that means that they are not supporting ME and should openly state so! PwME should demand that any organization that supports SEID should not use the name ME or the conflated name ME/CFS.
#PwME4ICC Are Fighting Back
Hundreds of thousands of Americans suffer from the disabling neuroimmune disease myalgic encephalomyelitis. They have suffered severely for decades. Many have died prematurely. They have lost their health, careers, income, healthcare, family relationships, and friends. On top of that, their own government health agencies refuse to properly and accurately use the experts’ definition and name for their disease. This is malfeasance of the highest order!
Some organizations who should be there for these severely ill patients are the very ones who aid in their betrayal. These organizations are financially supported by the very ill patients they purport to represent – who are often financially destitute. The organizations should be the ones fighting for these patients for recognition of their disease, myalgic encephalomyelitis as defined by ME experts – yet, shamefully – they are doing the opposite.
Activists and people with ME are fighting back against the deception and silencing tactics by HHS and organizations who are complicit with them.
Silence encourages the tormentor, never the tormented. – Elie Wiesel
“I don’t recall anything in the IOM report that states that the term myalgic encephalomyelitis, or ME, can not be used to describe who meets published ME criteria” – Lucinda Bateman – Global Chronicle 009 p 24
The Institute of Medicine/systemic exertion intolerance disease (IOM/SEID) criteria which the US Centers for Disease Control and Prevention (CDC) is currently promoting on their website and to medical professionals for diagnostic purposes does not define the distinct disease myalgic encephalomyelitis (ME). The National Institutes of Health is inaccurately recommending the use of the diagnostic IOM/SEID criteria as one of several choices of research criteria for studies at the NIH-funded ME/CFS Consortium Centers. Some NIH-funded researchers are already incorrectly selecting people for their studies using the IOM/SEID diagnostic criteria.
The criteria for chronic fatigue syndrome (CFS-Fukuda), systemic exertion intolerance disease (SEID-IOM) and the deceptive combination ‘ME/CFS’ do not define the disease ME.
What is ME?
Myalgic Encephalomyelitis (ME) is an acquired distinct disease, recognized and defined by international ME experts (Ramsay Criteria, Canadian Consensus Criteria (CCC), and the International Consensus Criteria ( ICC). ME is classified as a neurological disease by the World Health Organization (WHO). ME has appeared in 50+ outbreaks worldwide and in sporadic form – severely disabling millions of men, women, and children worldwide. It is a polio-like disease attacking the nervous system, reactivating viruses, and causing muscle weakness and pain. It becomes systemic, eventually affecting many body systems such as the immune, endocrine, metabolic, energy systems, and the heart.
What is CFS/SEID?
CFS and SEID are government constructed vague entities defined based on the common subjective symptom fatigue. HHS has repeatedly attempted to control the narrative about this disease with creations of overly vague definitions and demeaning names. HHS hoped that with their efforts in obfuscating the scientific and historical evidence, they will accomplish the disappearing of the disease (See evidence in a document obtained via FOIA request here).
ME is not CFS
The 2015 IOM report states in its opening paragraph: “Myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS) are serious debilitating conditions that impose a burden of illness on millions of people in the United States and around the World.” (ME and CFS are described as two separate “conditions” – even though ME is a distinct disease and CFS is an assortment of conditions which are based on the subjective symptom- fatigue)
The ICC definition for ME is based on neuroimmune pathology which is consistent with the neurological classification of ME in WHO. It includes specific testing to aid in diagnosis including immunological and cardiology testing.
The IOM/SEID definition does not demand any neurological nor immune dysfunction. It is a simple checklist of 4 out 0f 5 subjective symptoms common to many chronic illnesses and does not require specific testing for diagnosis.
Reasons to Insist on Recognition of ME as per the ICC:
Vague criteria such as the CDC’s Fukuda and IOM/SEID result in many people misdiagnosed with the disease. This harms everyone involved. Those who suffer from another condition will be stuck with a wrong diagnosis and wrong treatments. Those with the actual disease will get recommendations for inappropriate and possibly harmful treatments such as graded exercise therapy (GET) and cognitive behavioral therapy (CBT).
The ICC, unlike the IOM/SEID definition, does not require a 6 month waiting period for diagnosis. The sooner one gets diagnosed, the sooner they can get recommendations for appropriate treatments. We know from experience that the sooner pwME start treatments such as rest, antivirals, immune modulators, the better their chances of improvements.
Unlike the IOM/SEID which includes the symptom of post-exertional malaise (PEM), the ICC includes Postexertional neuroimmune exhaustion (PENE pen′‐e) which is a more accurate description of what pwME experience. The ICC acknowledges and addresses brain inflammation, whereas the IOM/SEID states there is no evidence of brain inflammation.
The ICC was created for both – diagnostic and research purposes. The ICC authors knew that HHS has misused the intention of previous criteria. They, therefore, took the precaution of creating a set of criteria which could be used for both. In direct opposition of what ME stakeholders were promised, HHS is already recommending the use of their newest diagnostic criteria for research purposes.
The problem with the use of overly broad criteria for research is that it creates confusing results because it is not targetting a specific disease. The lack of meaningful study results stunts scientific advances and recommendations for appropriate treatments for the disease.
The IOM/SEID authors clarified that they did not take severe ME into consideration when creating their criteria. It is impossible to accurately define a disease by omitting 25% of the most severely affected. The resulting simple checklist of common subjective symptoms in the IOM/SEID does not describe ME.
The IOM report states on page 23: “Because of the large number of results, the committee reviewed only papers published during the past 10 years with the understanding that older research is considered and cited in the introduction and discussion sections of more recent literature.” Dr. Ramsay’s important work and the critical evidence of ME worldwide outbreaks were not looked at by the IOM/SEID authors.
The ICC recommends specific testing to aid in diagnosis. The IOM/SEID does not. The lack of directed testing will impede the ability of pwME to get insurance to pay for particular tests for ME. Additionally, it will be hard/impossible to get insurance coverage for ME treatments like antivirals because the IOM/SEID criteria do not include any symptoms of viral or inflammatory nature.
What You Can Do
ME is in danger of being erased by the efforts of HHS. Please take the time to read, join the over 4,400 who already signed and sign the petition for recognition of ME as per ICC. Please share widely. If each one of you gets another individual to sign, we can double the number of signatures.
The much-anticipated revision of CDC’s website on ‘ME/CFS’ section “Information for Healthcare Providers” was unveiled July 12, 2018. The main reason for the revision was to adopt and educate medical professionals to diagnose people using the government-sponsored clinical IOM/SEID criteria and to update the toolkit based on current scientific data.
The result of the CDC website update is full of deceptions and in many ways worse than the old toolkit for medical professionals.
Problems and Danger with Adopting and Using the IOM/SEID Criteria
ME advocates have warned that the 2015 government-sponsored IOM/SEID criteria are even worse than the failed and highly criticized government 1994 Fukuda definition. Critics of the Fukuda definition argue that it was overly broad with too much emphasis on the one common symptom ‘fatigue’. The IOM/SEID definition is even more vague. Unlike the Fukuda, it doesn’t specify exclusions which means that many people suffering from primary psychiatric and psychological conditions will get a diagnosis of IOM/SEID.
Even worse, the new criteria do not demand any neurological nor immune dysfunction symptoms! Investigators (Dr. Leonard Jason, Frank Twisk and Asprusten et al) who have looked into the IOM/SEID criteria and published papers comparing it with other definitions have warned that it does not define the neuroimmune disease myalgic encephalomyelitis (ME) as defined since 1969 by the World Health Organization (WHO) and coded under Neurological disorders as ICD – G93.3.
The IOM authors clarified this distinction as well. They stated that the entity they were defining was not a neurological one. It was a broader entity with subsets which remain to be defined. They were clearly not defining the distinct disease ME as per our international non-government medical ME experts with their 2011 International Consensus Criteria (ICC). This comparisonchart created by the patient organization MEadvocacy.org is an easy visual tool that illuminates the difference.
The danger of using the broad IOM/SEID definition is that the pool of patients diagnosed will be a muddied group. It will be harmful to those who suffer from ME as per ICC and those who suffer from other conditions for which they lack proper diagnosis. To properly treat patients one needs to identify precisely the disease they suffer from. It would be like throwing people who suffer from rheumatoid arthritis and osteoarthritis together under one rubric because they share many of the same symptoms. This conflation would be dangerous because as we know, the treatments are entirely different.
Even more alarming, ‘ME/CFS’ investigators working at NIH funded ‘ME/CFS’ consortia are currently using the clinical IOM/SEID to select their cohorts in their studies! Using this faulty criterion will cause the group to be made up of people suffering from different conditions. The results will be skewed whether searching for a biomarker or successful treatment options. It will be impossible for future researchers, who are unfamiliar with the criteria issues, to duplicate studies as they will have no way to know how to select patients correctly.
Harmful GET recommendation Without the Name Remains on Website
CDC’s previous toolkit for providers recommended graded exercise therapy (GET), stating: “Graded exercise therapy (GET) has shown to be very helpful to some CFS patients. Graded activity and exercise are defined as starting from a very low, basic level of exercise and/or activity and gradually increasing it to a level where people can go about their daily life. NOTE: the level of activity may not be the same as before the CFS diagnosis.”
CDC’s current toolkit treatment section recommends: “Patients who are tolerating their current level of activity and have learned to “listen to their bodies” might benefit from carefully increasing exercise to improve their physical fitness and avoid deconditioning Some healthcare providers with expertise in ME/CFS refer their patients to an exercise physiologist who understands ME/CFS and uses an individualized and flexible approach to advancing activity levels.” [bolding for emphasis]
CDC is in effect still educating doctors to recommend people with ‘ME/CFS’ exercise incrementally. This description is what graded exercise is, and it is genuinely devious of CDC who many in the community have hailed for supposedly removing GET from their toolkit, only to see them re-introducing it in a concealed manner. ME advocates and patients who have been on this road with CDC for decades are not surprised at their repeated deceptions. Their malfeasance has no bounds, and they will do anything to cover-up the reality of the neuroimmune disease ME which has appeared in many worldwide outbreaks and the sporadic form.
Dangers of Conflation Which Result in the Burial of ME
CDC states: “There is no consensus on whether CFS and ME are synonyms, different spectrums of the same illness, or distinct conditions.”
These words describe the crux of the problem with the government’s attempts to cover-up ME. It benefits HHS to keep it all a big, muddied, confused heap of nothing. It has been their intention from the start – to make ‘CFS’ go away. As a 1994 letter obtained through FOIA effort by advocate Craig Maupin from NIAID’s Dr. Straus to Dr. Fukuda states:
“I’ve felt for some time, Kieji, that those that have CFS are at a certain point along a continuum of illness in which fatigue is either the most dominant symptom or the most clearly articulated by virtue of impression on the part of the patient or physician that such a complaint is important. I predict that fatigue itself will remain the subject of considerable interest but the notion of a discrete form of fatiguing illness will evaporate. We would then, be left with Chronic Fatigue that can be distinguished as Idiopathic or Secondary to an identifiable medical or psychiatric disorder. I consider this a desirable outcome.“
HHS and its agencies have purposefully acted to conceal the fact that this is a distinct disease with its distinguished history. They have repeatedly misbranded (CFS, ME/CFS, SEID), misdefined (Fukuda, Reeve’s, IOM/SEID) the disease to keep the confusion going. They have also falsely combined ME with CFS as in ME/CFS to perpetuate the confusion. It’s like calling a disease lung cancer/cold!
In the same vein, HHS repeatedly refuses (in contrast with other diseases) to accept and adopt criteria created by the international non-government experts in the disease [Canadian Consensus Criteria (CCC) and ICC] which clarify and distinguish ME. With the same concealment tactic, CDC erased our experts’ criteria CCC and ICC from their resource section.
Other Tactics Used by CDC to Minimize the Disease
CDC prides itself on the use of evidence-based scientific data, yet they state on their new website “Some patients return to full function” as if that is a scientifically proven fact. Which evidence-based studies is CDC relying on when making this positive statement? I would argue that there is more evidence of people with ME #(pwME) dying from ME than fully recovering from the disease.
In their Spectrum of ‘ME/CFS,’ CDC states: “For example, patients mildly impaired by ME/CFS may be able—with careful planning and activity management—to keep a job or continue their education, participate in social and family activities, and attend to daily life.” This statement gives the false impression that pwME if managed well, can perform normal activities of life. It is a false assumption and does not ring true with pwME. For an ME diagnosis, pwME need to have extensive reductions in previous activity. Activity management might ensure that they do not aggravate their condition and avoid crashing but, it does not improve their base condition.
CDC states: “From a clinical perspective, case definitions are used to make the appropriate diagnosis and guide therapy and management. From a research perspective, case definitions are used to identify the appropriate study population. Multiple case definitions may be required for different applications and can co-exist if there is a good understanding of how they are being used.” Historically, HHS has conflated the purpose of criteria. They have used definitions whose goal was for research, in clinical settings and vice versa. ‘ME/CFS’ investigators are already using the clinical IOM/SEID definition for studies at the NIH funded ‘ME/CFS’ research consortia – despite assurances it by HHS they would solely be used for clinical purposes!
In CDC’s attempt to conceal any possibility of an infections agent playing a role in ME, they have omitted the history of ME and the fact that it appears in the epidemic for with 50+ worldwide outbreaks.
It is alarming to see this revised CDC criteria in 2018 – more than 30 years after CDC was called down to investigate the massive Lake Tahoe outbreak. The name, definition and data do not reflect the findings at Lake Tahoe nor the WHO 1969 defining ME under neurological disorders nor the 2011 International Consensus Criteria defining the distinct disease ME.
ME advocates worldwide are rightfully aligning in their fight against the PACE Trial with their recommendation of the harmful treatments of graded exercise therapy and cognitive behavior therapy. ME advocates need to do the same with CDC’s revised website which is deceptive because like the Emperor’s New Clothes – it is just more of the same wrongdoing. ME advocates need to rigorously fight CDC’s dangerous recommendation of GET and their use of the vague IOM/SEID definition which will result in the burial of the distinct disease myalgic encephalomyelitis.
My thanks to advocate Eileen Holderman for her consultation on this blog post.
“Hypocrites get offended by the truth.”
― Jess C. Scott
On May 17, 2018, I wrote a blog about the actions by the organizations MEAction, Solve ME/CFS, and MassCFIDS to introduce a Senate resolution ( S.Res.508 – dated May 15, 2018) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) International Awareness Day. ME advocates and the organization MEadvocacy strongly objected to the deceitful inclusion, by the organizations mentioned above, of the Institute of Medicine (IOM) recommendations into the Senate Resolution.
The three organizations purportedly representing the ME community are keenly aware that a significant segment of the Myalgic Encephalomyelitis (ME) community strongly disapprove of the IOM recommendations (see details of HHS’ charge to IOM and the resulting recommendations here) yet, chose to inject the IOM recommendations in the Senate Resolution.
In response to multiple objections in June 2018, the three organizations published a clarifying letter to the community about the “confusion” regarding the language in the Senate Resolution. In their letter, they claim that “one line was inadvertently changed” which became a cause of “confusion and upset” in the community. Their intent, they explain, was to get Senators on record as:
“1) supporting the IOM’s finding that ME/CFS is a devastating, biological, multi-system disease, and 2) supporting the IOM’s clear call to federal agencies to increase biomedical research.”
Double Speak:
Language in official government documents are precise and are read at face value. The intent in the minds of those who pen the wording is inconsequential. Congressional representatives, politicians and everyone reading the document will come to the false understanding that the IOM Report is commendable and its recommendations are admirable.
The two points of “intention” mentioned above were never part of the recommendations of the IOM Report (as seen here). Additionally, to recommend an entire report with the extrapolating of one specific sentence in a 282-page document is inane, especially, when the resulting recommendations are inaccurate and damaging.
The IOM Report was not charged with recommendations regarding research. It was HHS’ P2P work which produced their own report on the needs of research in ‘ME/CFS’ – not the IOM. The IOM’s charge was limited to the diagnosis of the disease.
The Solve ME/CFS/MEAction/MassCFIDS letter further states:
“Our intent was not to support the IOM’s suggested name change to SEID or the IOM diagnostic criteria“
Double Speak:
The name change to SEID and the new IOM diagnostic criteria were part of the actual recommendations of the IOM Report. How are we to believe that organizations who claim to represent the community of people with ME (pwME) get that most important fact wrong?
It is hypocritical for these organizations to state that they are not supporting the IOM diagnostic criteria when in fact, they have been and are continuing to aid the Centers for Disease Control and Prevention (CDC) in adopting, implementing, educating and disseminating the IOM diagnostic criteria!
In conclusion, the three organizations want to be “extra clear”:
“Neither our advocates, our organization, nor members of the Senate are pushing for the NIH to rename the disease nor to adopt the diagnostic criteria.”
Double Speak:
Do you see what they did here? Reread it. They are saying that they are not pushing the NIH …(NIH the research agency of HHS) to adopt diagnostic criteria! It is the CDC who forced the IOM/SEID criteria on us, despite worldwide protests against it. And it is the CDC who have adopted, implemented and disseminated the IOM/SEID diagnostic criteria – not the NIH.
ME advocates reject the IOM recommendations and therefore reject the entire report the work was based on. In its opening paragraph, the IOM authors stated: “Myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS) are serious debilitating conditions that impose a burden of illness on millions of people in the United States and around the World.” They qualified that ME is not CFS. Later in the report, the authors stated: “The Committee deemed the term “myalgic encephalomyelitis,” although commonly endorsed by patients and advocates, to be inappropriate because of the general lack of evidence of brain inflammation in ME/CFS patients, as well as the less prominent role of myalgia in these patients.” The IOM report distinguished that the entity they were defining was not ME.
The rebranding attempt with the name SEID was ill-received by the majority of the community, and those who have published works vetting the IOM/SEID criteria and comparing to past definitions have agreed that it is a weak, overly broad criteria – even more general than Fukuda and not descriptive of ME (see Jerrold Spinhirne’s Note here).
Betrayal
The three organizations who have elected themselves to represent #pwME – in actuality are not. If they were serving pwME, they would push for the criteria authored by ME experts – the 2011 International Consensus Criteria (ICC) for diagnosis and research – not the vague ‘fatigue’ IOM/SEID definition.
It is hypocritical to brand yourself as representing one disease, yet push and aid for adopting a different entity. Long-standing ME advocates and pwME understand the distinction but, those who are newer to the community do not – and this deception is grossly misleading and harmful. The three organizations are in actuality aiding the CDC by serving on workgroups to facilitate the adoption, dissemination, and education of the IOM/SEID diagnostic criteria – yet they state they are not supporting it.
The language used by MEAction Network, Solve ME/CFS Initiative and MassCFIDS/ME & FM Association in their letter to the community is what we have become accustomed to from the government health agencies for three decades with their deliberate deception and harm inflicted on the ME community. The fact that these three organizations who purport to represent the ME community are employing the same government tactics is appalling and harmful.
The ME community has experienced the disastrous ill-effects of using obfuscating, ‘fatigue’ based criteria for more than three decades. We will not stand by in silence for more of the same.
Relating to ME 