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Standardizing Measurement of ME/CFS Core Symptoms

Dr. Suzanne D. Vernon, BHC research liaison, explains how the IOM report defining the core symptoms of ME/CFS also define the BHC research roadmap.

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Suzanne D Vernon

Suzanne D. Vernon, PhD  BHC Research Liaison

At the October 2012 CFS Advisory Committee meeting Dr. Sandra Kweder, Deputy Director of the Office of New Drugs at the FDA stated, “When there is confusion, lack of consensus and no progress, go back to the core”.  Dr. Kweder was explaining why there are no FDA approved drug treatments for ME/CFS. She told the audience that by  “core” she meant the disease-defining concepts that describe the signs, symptoms and decrements in specific functioning experienced by patients. Dr. Kweder went further to say that without these core-defining concepts investment in developing treatments for ME/CFS would be slow.  She asked, “Would you invest in developing a treatment surrounded by such uncertainty?”

But the FDA was intent on moving the regulatory path forward for ME/CFS and in March 2014 the FDA published draft industry guidance for developing drug products for ME/CFS treatment. Because ME/CFS disease defining concepts were still uncertain, this guidance indicated that, “At this time, the FDA does not recognize any particular disease definition, nomenclature, or diagnostic criteria for CFS/ME as the most appropriate for use in clinical trials of new drug products” leaving the door open for sponsors to define ME/CFS (with adequate justification) and target subpopulations like orthostatic intolerance, disturbed sleep, etc. in their clinical trials.  The guidance recommended that drug efficacy be determined by patient-reported outcomes – how a patient feels or functions – and that biomarkers could be used as exploratory endpoints.

Less than a year later in February 2015 the Institute of Medicine (now called the National Academy of Medicine) published proposed clinical diagnostic criteria for ME/CFS in a report titled, “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining and Illness”. This was a landmark publication!  The report described  three core symptoms of ME/CFS as impaired day-to-day function, post-exertional malaise, and unrefreshing sleep as universally present in ME/CFS patients.  In addition, either cognitive impairment or orthostatic intolerance must be present as a fourth core symptom for a diagnosis of ME/CFS; plus all core symptoms must be frequently present and at least moderately severe.  These clear and concise diagnostic criteria paved the way for health care providers to diagnosis and care for patients.

These core criteria also defined the research roadmap for the Bateman Horne Center.

The BHC mission is to mainstream ME/CFS and FM into medicine.  This means giving health care providers the tools they need to diagnose and treat patients.  This is an ambitious goal given that we are following Dr. Kweder’s direction by going “back to the core”. But with the universal core symptoms identified, the path forward for BHC is clear.  Our objective is to develop tools that can be used to measure the core symptoms making it easier for health care providers to make the diagnosis and to give us ways to measure a change in a core symptom in treatment trials (this is known as an outcome measure).

Here’s how BHC is tackling each of the core symptoms:

  • Impaired day-to-day function: measure hours of upright activity (the amount of time over 24 hours a patient’s feet are on the floor)
  • Unrefreshing sleep: test affordable wearable devices that can be used at home over long periods of time to get a more realistic picture of disturbed sleep
  • Orthostatic intolerance: standardize a 10-minute lean test and measure hemodynamics, heart rate and heart rate variability, skin temperature and galvanic skin response using conventional and wearable devices
  • Cognitive impairment: use brain testing software that can assess processing speed and reaction time in minutes to measure brain fog

Standardizing the way the core symptoms of ME/CFS are measured will be a great attractor for the pharmaceutical industry.  This will encourage them to look into their pharmacopeia to find drug treatments that can target the core symptoms of ME/CFS.  Having the tools to measure the core symptoms is what is needed to get pharma to invest in ME/CFS treatment trials.

BHC is leading the way, working collaboratively with many others to put ME/CFS and FM into the medical mainstream. But we can’t do it alone; you play an important role in our progress.

Join us if you can… wear wild socks, maintain hope, speak up, stand out, volunteer, take action and donate.

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2 Comments

  1. lolly vann on January 31, 2017 at 4:09 am

    I think standardization is great, for particular cohorts. But patients who are off the grid hobbling together management strategies for years and years, who have collected the assorted additional ailments that sometimes accompany both age and chronic illness encourage may not present the same as a patient relatively new to this disease process, or those receiving regular at the doctors offices. I fear that patients that do not present like the ones regularly seen in the specialized offices are at risk of exclusion if the life cycle of this disease is not better viewed and recorded. I love the work and the patient support coming out of the Bateman Horne Center and look forward to what it brings to our futures. Thank you for all you do.



  2. Sharon Rousseau on February 1, 2017 at 12:43 pm

    Big fan, great work over the years. Love the education directions, I have an idea I would love to run by you and Dr. Bateman et al. It is so important that some of our precious research dollars go towards subgrouping. I have a simple idea putting everyone on the same page from what we know now. I will send you an email and hope it makes it through to you. Looking forward to Dr. Lights webinar tonight.
    My 17th anniversary contracting ME/CFS is on March 15, 2017. Thank you for hanging in there all these years.
    S.