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Reasons Why #PwME Should Sign the Petition to HHS for Recognition of ME as Defined by ICC

/ Gabby Klein

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“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.

Petition in English here

Petition in Dutch here

Petition in French here

Petition in Spanish here

Petition in Italian here

Petition in German here

 

 

 

 

 

 

 

 

 

 

 

 

Double Speak and Betrayal from Within

/ Gabby Klein

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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.

CFSAC Comment, Gabby Klein – January 13, 2017

/ Gabby Klein / 7 Comments

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) met January 12 and 13, 2017. Here is the meeting agenda.  The following was my call-in testimony.

Hi, my name is Gabby Klein.  I am a patient advocate and blogger.  I have been ill with ME for 14 years.

As I sat down to write, I thought of our current situation as ME patients at the start of the year 2017. I thought about the comparison of the state of  ME patients today to a decade or three ago and became aware that there have been next to no improvements made throughout the years.  Due to HHS neglect and misdeeds, over 30 years after the Lake Tahoe outbreak:

  • Few doctors nationwide have the knowledge and experience necessary to properly diagnose and care for patients.
  • The same harmful GET and CBT therapies continue to be recommended by HHS.
  • There are no FDA-approved drugs.  
  • NIH still spends a minuscule amount of money on a disease with an enormous economic, mortality and quality of life burden.
  • The CDC and other HHS agencies continue to spread incorrect, harmful information on their website and in their continuing medical, educational material.
  • The unscientific and demeaning name, CFS, is still being used and the government still controls and fabricates incorrect and overly broad definitions – like the IOM.
  • HHS continues to cover up their negligence and malfeasance with the creation of more committees, workshops, and working groups – giving the false impression that they are actually doing something for the patients.
  • There is a continuing lack of transparency as well as a withholding of crucial information from the patient community.  The recent incident of NIH’s invitation – by Dr. Walitt with Dr. Nath’s approval, to ME denier Dr. Shorter to lecture on the false history of the disease, was a prime example.
  • False promises are frequent as in Dr. Collins promise of a considerable increase in funding for ME/CFS. It has in reality resulted in mere crumbs – an increase of $7 to 8 million for a million US disabled patients!  Moreover, in his eight years of service as NIH director, Dr. Collins has never mentioned ME/CFS when speaking to the Senate Appropriations Committee advising on specific increases in NIH funding.

Until HHS publically apologizes to the ME community for their three decades of neglect and malfeasance and until the time when HHS

  • exclusively uses our expert criteria – such as the CCC, ICC, or Ramsay’s
  • uses the correct name myalgic encephalomyelitis (ME)
  • properly educates medical practitioners
  • and appropriates NIH funding to the figure of a minimum of $250 million a year- which is on par with other similarly burdened diseases

I will continue to challenge and hold the federal government accountable.

 

Promises, Promises: Thirty Years of NIH Broken Promises

/ Gabby Klein / 7 Comments

 

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The pattern of 30 years of NIH broken promises to the myalgic encephalomyelitis (ME) community is continuing unhindered.  Representatives of the NIH ME/CFS Clinical study and the Trans-NIH Working Group make empty, insincere promises. They assure us that our voice and input is essential when in reality their actions entirely dismiss our view.  More alarmingly, it has become apparent as of late that those at NIH responsible for ME research, doubt the biological nature of the disease.  This unscientific hypothesis will affect every process that NIH takes and the result would adversely affect ME patients for a long time to come.

Recently, ME patients and advocates raised critical concerns with the NIH ME/CFS Study (see MEadvocacy blog: NIH Sidesteps Critical Problems with the ME/CFS Study).  NIH refused to move on adopting the many recommendations outlined to them, some of which were: to include the patients and advocates’ voice in every step of the study starting from the planning stages, removal of problematic NIH investigators who believe that the disease is a somatoform disorder, initiating, and maintaining a transparent and two-way communication process between NIH and the ME community (researchers, clinicians, advocates and patients).

A petition started by MEadvocacy, signed by 750 ME community members, and delivered to NIH Director Francis Collins on February 15, 2016, calling for the cancellation of the proposed NIH ME/CFS Clinical Study and restarting with input from the ME community of patients, advocates, researchers and clinicians was ignored and went unanswered.

The following is a more recent incident showing the same disrespect to the ME community.

Since November 3, 2016, the ME community has contested the scheduled appearance of the ME disease denier Edward Shorter as a lecturer on the history of ME/CFS at The National Institutes of Health Clinical Center in Bethesda, MD.  Patients, advocates, researchers, and patient organizations wrote letters to NIH demanding the cancellation of Shorter’s controversial lecture because of his career of spreading unscientific postulations that ME/CFS is a” psychic epidemic” of women who are attention seekers.

Shorter’s lecture took place on November 9th as scheduled, despite mass protests from the ME community including researchers who tweeted and spoke out.  Below is the reply sent by The Trans-NIH ME/CFS Working Group to the members of the ME community which is completely unresponsive and dismissive of the ME/CFS community’s opposition. 

Dear members of the ME/CFS community,

You have written to express concern about the NIH lecture by Edward Shorter that took place on November 9th.  Thank you for sending us your thoughts.

Please know that the lecture you asked about was not sponsored by either the ME/CFS Special Interest Group or the Trans-NIH ME/CFS Working Group, which means that it does not reflect the ideas, opinions, or policy of the NIH or the scientists now working on this disease.  Given the professional and learning environment that NIH promotes, dozens of people come each week to the NIH to exchange ideas with NIH scientists; the scientists who attend these lectures frequently challenge or disagree with the speakers’ ideas. In scientific circles, disagreement with what is said is often more scientifically productive than agreement.  The exchange of information and divergent opinions, followed by critical analysis, is essential to moving any field forward.  The most important thing that we wish to share is that NIH remains firmly committed to using scientific methods to uncover the biological mechanisms that cause ME/CFS and to improve the lives of people who have been suffering for years, and even decades.  Comments made in a seminar will not undermine the progress of science at NIH.

Several of you have asked why the lecture was not mentioned during the telebriefing that NIH hosted on November 2nd.  The telebriefing was intended to discuss the efforts of the Trans-NIH ME/CFS Working Group and the progress made in initiating the NIH Intramural research clinical study.  The lecture was not part of those efforts.

The speaker shared his viewpoint, the scientists who attended asked questions, and perspective was provided by a patient and a community physician. The lecture was attended by approximately 15 scientists, including some who are part of the clinical study investigative team.  It is fair to say it will have no impact on NIH’s interest in doing everything we can to advance the science of ME/CFS.

Regards,

The Trans-NIH ME/CFS Working Group

If you pay close attention to the exact verbiage used in this reply, you will see a prime example of government “double-speak” in an attempt to cover up their transgression.

  • “The lecture you asked about was not sponsored by either the ME/CFS Special Interest Group or the Trans-NIH ME/CFS Working Group”.
    • The use of the word “sponsored” is deceptive.  It implies that the ME/CFS Special Interest Group or the Trans-NIH ME/CFS Working Group didn’t pay for Shorter’s lecture but, it doesn’t tackle the question of who extended the invitation.
  • “Which means that it does not reflect the ideas, opinions, or policy of the NIH or the scientists now working on this disease”

    • The fact that they didn’t “sponsor” Shorter’s lecture does not qualify as proof that it doesn’t reflect the opinions of NIH investigators.  We are keenly aware and have spoken out about the fact that NIH researchers Drs. Walitt, Gill and Saligan, share Shorter’s beliefs that ME is a somatoform disorder. Dr. Walitt has repeatedly quoted and referenced Dr. Shorter in his works and was the one who introduced Shorter at the lecture at NIH.

  • “In scientific circles, disagreement with what is said is often more scientifically productive than agreement.”
    • Yes – a scientific debate is useful and fruitful.  The only problem is that there is nothing scientific about Dr. Shorter’s false beliefs about ME.  It is based on a fantastical myth created in Shorter’s warped mind. 
  • “The most important thing that we wish to share is that NIH remains firmly committed to using scientific methods to uncover the biological mechanisms that cause ME/CFS.”
    • In reality, NIH has not followed through with their words. NIH refused to remove investigators who share Dr. Shorter’s psychogenic views of the disease from the clinical study. In his recent reply to the community, Dr. Koroshetz expresses that Shorter’s viewpoint about ME being psychosomatic is a valuable possibility.
  • “The speaker shared his viewpoint, the scientists who attended asked questions, and perspective was provided by a patient and a community physician.” 
    • Before the lecture, NIH representatives stated that this speech was exclusively for NIH intramural investigators. Outsiders were not permitted to attend.  Somehow one patient and one community physician were present for Shorter’s lecture. Were they used as token representatives so that NIH can “claim” community involvement?

The most important takeaway from this experience is that regardless of whose idea it was to invite (all signs point to Dr. Walitt) Shorter to lecture NIH investigators or who actually “sponsored” it, no one at NIH acted on our opposition and canceled the talk.

Additionally, this ME denier’s fabricated history of ME/CFS which he perceives as a psychogenic social female condition, masked the real history of myalgic encephalomyelitis – starting with several global outbreaks which attest to an infectious component of the disease.  We have many ME historians who are well prepared to lecture about the real historical path of ME.  Professor Malcolm Hooper has written extensively about the history of ME.  Dr. Byron Hyde is an accomplished author writing about the history of ME as well as the science.  Investigative journalist Hillary Johnson authored the acclaimed book Osler’s Web – a well-documented detailed account of the history of the disease. Hillary currently maintains a subscription-based news page, The Eye View, that covers people, politics and scientific developments in the field of ME. History professor, advocate, and patient Dr. Mary Schweitzer is currently writing a book on the history of ME and maintains a blog site, Slightly Alive, where she writes extensively about the historical facts and current events in ME.

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Image created by MEadvocacy.org

Despite Walitt’s psychogenic bias of ME, NIH has refused to remove him from the NIH ME/CFS Clinical Study.  Instead, NIH keeps praising him as in the NIH call November 2 with advocates.  Dr. Nath replying to a question asked by patient advocate Eileen Holderman regarding Walitt remaining in the study replied: “And then Dr. Walitt, yes. So Dr. Walitt is a, you know, delightful individual, very experienced. I have full confidence in him. And so he’s doing a superb job putting this protocol together. He has done all the work in helping me.”

HHS’ disregard of the ME community has become a contemptible pattern – signifying a widespread institutional bias.  Although HHS claims that things have changed, their actions disprove their words.

They disregarded and continue to ignore the ME community’s call for:

  • Adopting and using the correct historical name for the disease – myalgic encephalomyelitis
  • Adopting and using criteria created by our ME experts (CCC, ICC and Ramsay’s)
  • Appropriate funding commensurate with similarly burdened diseases – minimum of $250 million annually ($7 million annual increase is an insult and will not accomplish what is scientifically needed)
  • Proper education about the neuro-immune disease ME (not a fatiguing or somatoform disorder)
  • Real input from ME patients and advocates into the process (as opposed to just a perceived seat at the table)
  • Placement of the disease in one of the many NIH institutes, such as the National Institute of Neurological Disorders and Stroke (NINDS) or the National Institute of Allergy and Infectious Disease (NIAID). (Incidentally, ME/CFS still appears under the Office of Women’s Health)
  • Acting on the many recommendations by the Chronic Fatigue Syndrome Advisory Committee (CFSAC)

It is time to reevaluate this broken relationship which is based on false promises, deception, and mistreatment. There is no urgency emerging from NIH in the face of this disabling disease that leaves an estimated million American men, women and children disabled, with no end in sight – many die in their youth, the rest die an average of 20 years early!  Promised RFAs for ME research are delayed by two years, and the amount of money involved remains a mystery.  The increase in extramural funding (which typically consists of 90% of NIH funding) is a meaningless increase of $7 million for 2017.  

We cannot sit by and allow to this slow paced distribution of crumbs to continue. Some in the ME community are so angered by the repeated betrayal by NIH that they are calling for a complete withdrawal – aggressive refusal.  

I agree with this aggressive refusal. We have witnessed the danger of federally funded research by investigators who favor the psychogenic view of the disease with the cataclysmic PACE trial and numerous other such studies by CDC. When all “a seat at the table” means is to enable the government to claim they gave us an opportunity for input yet they never act on our advice and requests – it is time to step away from this falsely implied collaboration and get our congressional representatives involved in advocating on our behalf.  

A congressional investigation as promoted by Dr. Davis of the Open Medicine Foundation might be the only way for us to finally gain respect, equality and fair treatment by the US government health agencies. ME advocates should rise and stand up for the rights of ME patients. Looking away and accepting abuse only reinforces more of the same. We cannot allow this institutional bias to continue with disregard, negligence, and inequality, causing substantial harm to ME patients.