biological

The ‘Mah Nishtanah’ of ME

/ Gabby Klein / 14 Comments

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

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

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

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

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

Mah Nishtanah ME Questions

Why is it that:

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

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

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

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

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

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

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.