Further Analysis of NIH Clinical CFS Study

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The Design of the Study Implies a Purpose

MEadvocacy published a blog yesterday about the posted US National Institute of Health (NIH) Study 16-N-0058 Chronic Fatigue Syndrome (CFS) Clinical Summary which stated, “This study is currently recruiting participants.”  We presented flaws and weaknesses of the study. We have initiated a petition calling on NIH to cancel the study, and calling for the CDC to cancel Dr. Nath’s presentation of this study at Center for Disease Control’s Grand Rounds fast approaching, this Tuesday February 16th. (Please note the link to the protocol of the NIH study has gone dark early this morning. See this web archived link for screenshot.)

Since then, unofficial NIH responses to criticisms of the study protocol have been circulating on social media.  Tracey Smith has written a great analysis of the remaining issues present with this proposed work.

Comparison Cohort Problems

The comparison cohort selections are very telling. They selected a post-infectious Lyme group that was "recovered" and a psychogenic functional movement disorder (FMD) group, a disorder defined as a type of somatoform disorder that results in neurological based symptoms. An obvious goal in selecting these cohorts, would be if I were to try to prove or disprove the psychosomatic labels that many neurologists and psychiatrists have assigned to CFS patients (mainly women) over the years.

Both of these cohorts tie into the Pace TrialDr. Simon Wessely school of false illness beliefs that are theorized to occur after an initial infection. Theory is that initial infection and the mind's response to it, results in misread signals causing observable change in the functioning of the brain. Thus the mind causes changes to the brain to perpetuate the illness belief. Cognitive behavioral therapy (CBT) is thought to be somewhat effective in counteracting this process, by retraining the mind not to believe the signals the brain is interpreting, and then graded exercise therapy (GET) is able to undo the deconditioning of a body that was not "allowed" to exercise due to the false illness beliefs.

The post-infectious Lyme group that is recovered is a comparison of a “healthy” recovery process.  But what is odd, why select post-infectious lyme?  A disease group full of controversy.

The FMD group will be for comparing biomedical findings associated with psychosomatic symptoms. What is concerning about the recent "advances" in research, is that neuroimaging is used often to confirm the mind's ability to cause physical change to the brain (e.g. study). How many misdiagnosed ME or even chronic Lyme patients have been labeled with these ambiguous FMD criteria and then entered into these neuroimaging studies under the pretext they were studying psychogenic symptoms? Then how easily would it be that these two cohorts, CFS and FMD overlap?  Click on this link for a study that touches on that very subject. Even, researchers have proclaimed, “Somatoform disorders are among the hardest disorders to diagnose and thus to treat.” (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2908292/) So this second cohort would add to the ambiguity, not provide clarity during comparison to the CFS cohort.  

Exclusion/Inclusion Problems

Then, to bias the study even further, one would logically select criteria and exclusions/inclusions for the CFS cohort that predominantly excludes those that have myalgic encephalomyelitis (ME).  Such as... excluding anyone that has infections (infections are common in ME patients).  Next step, exclude moderate to severe ME patients by requiring bike exercise testing twice during a week long stay in a hospital environment known to aggravate noise, light, and chemical sensitivities, and added discomfort and even pain due to unfamiliar bedding.  In addition, going through noisy MRI testing, multiple blood draws, breath, saliva samples, a spinal tap, multiple cognitive draining questionnaires, etc in a short period of time, would be taxing for even mild cases.

The moderate and severe patients would have the strongest biomarkers related to symptoms, excludes other common co-morbid conditions of ME patients such as thyroid disease, something that is easily treatable and has a blood test to confirm levels are normalized.  In contrast, they are allowing other co-morbid conditions such as depression to be included as long as it has been successfully managed for 6 months.  Which is puzzling, since there is no biomedical evidence or blood test to confirm that treatment was successful, only subjective evaluations from patients.  This shifts the CFS cohort to higher chance of containing only psychological patients of depression and anxiety.

This is like a road map for proving psychosomatic causation of CFS, and then they will just slap on the ME label to suit them.  Or the study will result in such confounding data that no conclusion can be made.

NIH had said the purpose of the clinical study was to gain as much data and biomedical evidence for ME/CFS, but that is not what the design of the study reveals.  The original purpose was a fact finding mission without an hypothesis, to “intensely study individuals with ME/CFS.”  Why include other disease cohorts when you are just wanting to find everything out about one disease?  The only comparison one would need is with a healthy population, then your resources can expand the ME/CFS sample size so that the results can be considered statistically significant. If resources were abundantly available for comparing other disease cohorts in order to better understand or connect a disease pathology or pathway to a more understood and widely researched disease, then choosing a similar neurological disease with immune pathophysiology such as Multiple Sclerosis or Parkinson’s would be more appropriate.

No matter what they say now or how they try to explain the protocol, the purpose is still evident. Finally, and most importantly, this remains a study of “fatigue” not the neuroimmune disease myalgic encephalomyelitis (ME).  It will be a waste of much needed funding which could have been applied to a real serious study of ME.


Please sign MEadvocacy’s petition, by midnight Sunday February 14th, calling for a cancellation of this fatigue study and a call for a real biomedical study on ME. Send a message to the government that ME patients will not stand for the misrepresentation of our disease with fatigue, depression and somatoform diseases any longer. We will not accept crumbs that will lead to meaningless results and/or cause further psychologization of a biomedical disease.

Showing 4 reactions

  • Julie Houska
    commented 2016-04-08 15:11:02 -0400
    Thank you for your comments. The comment period has expired. However, if you still wish to comment, please do so on our MEadvocacy.org Facebook page. Thank you for your interest.
  • Tracey Smith 💖
    commented 2016-02-12 19:19:35 -0500
    Great question Deborah.
    Here are some links to unofficial commentary (meaning no direct posting/ announcement from NIH, just personal conversations some individuals/advocates have had with NINDS).

    Post by ME Action: “NIH’S INTRAMURAL STUDY PROTOCOL RAISES MANY QUESTIONShttp://www.meaction.net/2016/02/08/nihs-intramural-study-protocol-raises-many-questions/

    Post by Courtney Miller: “POSITIVE ANSWERS TO INITIAL QUESTIONS RE NIH CLINICAL CENTER PROTOCOL” about Courtney and Robert Miller’s discussion with NINDs on subject of posted clinical study:

    Latest: New NIH Study Raises Questions, Concerns, Hackles [Recent conversation between SMCI and NIND’s Director Dr. Koroshetz] http://cfstreatment.blogspot.com/2016/02/new-nih-study-raises-doubts-concerns.html
  • Deborah Waroff
    commented 2016-02-12 13:51:00 -0500
    Where can one find the “unofficial NIH responses to criticisms of the study protocol” that you cite above as circulating on social media? Is there anything beyond the reasons for a rough and hasty protocol cited by myself and several other people?
  • Erik Johnson
    commented 2016-02-10 17:14:20 -0500
    When it comes to patient selection for any “study” which purports to be about “Chronic Fatigue Syndrome”, there is only one “scientifically acceptable” method.

    One rule that science says must NOT be broken.

    “The evidence which constituted the reasons for the creation of the syndorme ARE the object and purpose of the syndrome” Any attempt to set aside the charter evidence for the syndrome is an obvious breach of science.