Why MEAdvocacy Does Not Applaud the News from NIH...Yet


Placard showing a crown at the top and reading \

The Announcement 

The myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) community has welcomed and applauded the National Institutes of Health (NIH) News Release announcing a strengthening of efforts by the NIH to advance research for the disease.  The overwhelming feeling is that the promises outlined in the announcement ushers a new era of hope for the long suffering ME/CFS patients. 

NIH Director Francis S. Collins, M.D., PhD. assures: “I am hopeful that renewed research focus will lead us toward identifying the cause of this perplexing and debilitating disease so that new prevention and treatment strategies can be developed.”

The notice announces the readjustment of the Trans-NIH ME/CFS Research Working Group.  It will now be chaired by Walter J. Koroshetz, M.D. and assisted by Vicky Holets Whittemore, PhD- representative for the Department of Health and Human Services (HHS) on the Chronic Fatigue Syndrome Advisory Committee (CFSAC).  They will discuss gaps in research and look for scientific opportunity. This Group will be led by the National Institute of Neurological Disorders and Stroke (NINDS).  Although we are wary of yet one more working group, we hope this might result in more vigorous research into the disease.  It is not clear at all though how much and from where new funds will be coming from.  The notice states: “The Working Group includes representation from 23 NIH institutes, centers and offices” - yet no word about patient or advocate representation! 

Francis Collins, personally, called a few advocates/patients to impress on them his commitment to bring focus to this “perplexing and debilitating disease”.  In addition, Collins appeared on the CharlieRose.com station.   See transcript here.  Collins says about CFS “it’s a very heterogeneous collection of individuals”. “They can’t get out of bed...exertion makes it worse.”  He promises to bring new technology to study this mysterious disease.  By understanding fatigue in CFS, it will lead to understanding fatigue in other illnesses like cancer.

This announcement has prompted patient groups and advocates to sign a letter of thanks and a show of eagerness to work along with the Director of NIH.   We believe that applauding this announcement is premature. 

The History 

It is important to remember the history and context in which this promissory note presents itself. For the past 30 years HHS/NIH has given us many empty promises. 

  • HHS spent decades trying to bury the disease of Myalgic Encephalomyelitis (ME) - read “Thirty Years of Disdain”by advocate Mary Dimmock.  Despite all the advocacy efforts from the community to bring on a change, nothing has actually changed. 

  • In the past two years, HHS has been under attack by many advocates who have fought hard against the Institute of Medicine (IOM) and NIH Pathways to Prevention (P2P) governmental imposed actions. This advocate rebellion was augmented by the voice of disapproval of the IOM study from ME/CFS experts (via experts’ letter to Secretary Sebelius). Yet, HHS ignored the overwhelming voice of the ME/CFS community. 

  • HHS’s malfeasance was made clear with attorney and advocate, Jeannette Burmeister’s, successful lawsuit against them for their violation of Freedom of Information Act (FOIA) requests for IOM documents. NIH was a named defendant in the lawsuit which, among many things, included misrepresentations under penalty of perjury!

  • The very serious allegations by CFSAC voting members that the designated Federal officer (DFO), Dr, Nancy Lee,  intimidated and threatened them was never taken seriously by HHS.  (read advocate and past CFSAC voting member, Eileen Holderman’s, testimony) The call for investigation into this malfeasance by patient groups and advocates was never satisfactorily resolved and was basically dismissed. 

All this dismissal, malfeasance and neglect of the patient/advocate community has eroded whatever little trust advocates and patients had for HHS and those employees who up until now have been responsible for creating policy for the health and welfare of the ME/CFS patients. 

The Questions 

This welcome overture by the Director of NIH is a refreshing start but too many questions remain unresolved to take this leap of faith. 

  • Although some allusions have been made, to date, no Request for Application (RFA) has been issued. 

  • Vague words of promise of more funding have been made with no concrete figure of increase in actual extramural ME/CFS funding. 

  • There has been no clear action of ME/CFS being moved out of Women’s Health into one of the NIH institutes. 

  • There is mention of a promise for a small clinical trial at the NIH center.  But, skepticism remains as to patient selection.   The notice states: “..with plans to enroll individuals who develop fatigue following a rapid onset of symptoms suggestive of an acute infection.” Is this going to be another trial of a “fatiguing illness”?   

A year after the unrolling of the IOM  and the P2P reports, more questions remain which the community is still waiting to get answered. 

  • Will the IOM criteria be used as presented in the IOM report?  ME/CFS scientists, doctors, advocates, patient groups and patients have voiced their opposition to the criteria.  It is shown to be too broad and does not exclude other possible diseases whether physical or psychological. It is not representative of Myalgic Encephalomyelitis patients.  It has not been tested and proven to select true ME patients. 

  • At their last meeting of this year, CFSAC recommended additions and changes to the IOM criteria, which, if implemented, would greatly strengthen the deficiencies in the IOM recommendations Yet, HHS/CDC/NIH seems to have forged ahead without attention to CFSAC, which was charged by HHS to come up with the recommendations.   

  • Which criteria will be used for upcoming research endeavors?  The IOM was only charged with creating diagnostic criteria - not research criteria. To date, NIH has used the Fukuda criteria for research.  Will Fukuda continue to be used for research studies?  Fukuda leaves out the distinguishing symptom of post exertional malaise (PEM).  In effect, research will be using an even broader criteria than in diagnosis.  How does this make sense? 

  • The IOM and P2P reports recommend the retirement of the Oxford criteria.  There has been no formal acceptance of this recommendation from the government. 

  • In spite of this recommendation, NIH just published an article, “Exercise and Therapy, ’useful and helpful’ for chronic fatigue syndrome”, on Medline promoting the faulty British PACE “fake” treatments of graded exercise therapy (GET) and cognitive behavior therapy (CBT) for ”Chronic Fatigue Syndrome”! 

  • Apparently, the Centers for Disease Control (CDC) has taken their own initiative. Ignoring CFSAC recommendations and without any official announcement of approval of the IOM criteria, they are currently working on developing new ME/CFS educational material based on the IOM report.  They are recruiting patients to help them with this.  They have hired McKing Consulting, out of Fairfax, VA to head this project.  In addition, CDC is conducting 4 focus groups and 12 patient interviews. Their only criteria for patients is their word that they have been diagnosed with CFS or ME by a doctor.  See here. 

The Most Important Question 

The most important question remaining is: Which disease is the government talking about? Is it Chronic Fatigue Syndrome or Myalgic Encephalomyelitis? 

  • The IOM report makes a distinction between CFS and ME.  They state that they are not the same.  Dr. Francis Collins as well, talks about ME being different.  Yet, none of them have defined it nor selected criteria for it. 

  • The new US ICD-10 CM medical coding has separate coding for CFS and ME.  Myalgic Encephalomyelitis is coded under Neurological diseases. 

  • CFSAC, at their August 2015 meeting, recommended the use of the ME ICD code along with the IOM criteria that includes CFSAC updates. It is 4 months since that meeting and we have not received any response from HHS to this recommendation as well as the other 14 CFSAC recommendations. 

We at MEadvocacy.org have made our mission known from the start.  We represent patients suffering from Myalgic Encephalomyelitis using ME criteria - CCC or ICC.  We withhold our applause until the above questions get resolved and we see real concrete action by HHS.

Showing 3 reactions

  • Erik Johnson
    commented 2017-07-21 14:17:21 -0400
    As a member of the Incline Village cohort and prototype for CFS, who was in the NIH’s 1999 “original CFS cohort follow-up study”, I am aware that the NIH very well knows what the first CFS was coined to solve.
    Their pretense that they have to start over with their own study group betrays their desire to keep that “old” evidence buried.
    That is not how science is done. Anyone with an ounce of common sense can see that.
  • Susanna Degaardt
    commented 2015-12-04 07:59:14 -0500
    Thank you for pointing out important questions!
  • Russell Logan
    commented 2015-12-02 16:09:55 -0500
    Well done for posting this and not going with the crowd.