malfeasance

CDC the Puppeteer and the UK BPS Connection to Bury ME

/ Gabby Klein / 1 Comment

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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!

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exposing the Deception: SEID is not ME!

/ Gabby Klein / 1 Comment

 

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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.

screencapture-meaction-net-wp-content-upMEAction teaching SEID diagnosis (2)

When ME advocates asked Jen Brea on twitter to explain this disparity, her reply was this:

Brea tweet not advocating SEID

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:

Brea blocked me

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

 

 

 

 

 

Emperor CDC’s New Clothes

/ Gabby Klein / 3 Comments

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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 comparison chart 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. 

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.

me-deniers

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.