Highlights of Research Roundtable May 2

On May 2, 2015 Massachusetts CFIDS/ME & FM Association hosted a conference on current scientific research on ME/CFS sponsored by the Solve ME/CFS Initiative (SMCI). Guest speakers were Suzanne Vernon, Ph.D., research Director, SMCI, and Carol Head, CEO, SMCI.

Dr. Vernon gave an overview of the research program that SMCI is conducting. She described the projects and researchers they are funding, including introducing several researchers who are new to the field. It is encouraging that several researchers who have received initial funding from SMCI have gone on to get further funding from NIH. Dr. Vernon also described the SolveCFS BioBank, a patient registry which allows different researchers access to the same data. The SolveCFS BioBank is continuing to evolve including better definitions of symptoms and markers and access to more samples. SMCI is inviting ME/CFS patients and controls to register for the SolveCFS BioBank. Read more about how you can enroll in the BioBank.

You can help fund this research. Massachusetts CFIDS/ME & FM Association is accepting donations until June 30 for research. These funds will go to the SMCI research program described above.

Our next conference, planned for fall 2015, will focus on Fibromyalgia. Details will follow later.

Announcements

Centers for Disease Control and Prevention (CDC) recognizes CFS/ME Awareness Day May 12
It is encouraging that the CDC publicized CFS Awareness Day on their web site. This is the first time we have seen that the CDC has included ME as part of the name of the disease.

Advocacy

Institute of Medicine (IOM) report and our surveys
By now you may be aware that the Institute of Medicine issued a major report on ME/CFS in February, 2015, which clearly stated that ME/CFS is a “serious, chronic, complex and systemic disease that frequently and dramatically limits the activities of affected patients. In its most severe form, this disease can consume the lives of those whom it afflicts. It is ‘real.’”
The IOM was asked to 
1) Identify the evidence for various diagnostic criteria, with input from stakeholders;
2) Develop evidence-based clinical diagnostic criteria;
3) Recommend whether new terminology should be adopted for ME/CFS;
4) Develop an outreach strategy for disseminating the new criteria nation-wide to health professionals.

The report outlined the IOM’s recommendations. The report materials are available at this link: http://www.iom.edu/Reports/2015/ME-CFS.aspx. The agencies of the U.S. Health and Human Services (HHS), led by the Office on Women’s Health, must now decide whether to adopt and act on the recommendations. Wisely, these agencies are waiting to see how the recommendations are received by the ME/CFS community, and there has been a wide range of reaction so far. Some of you shared your personal responses in our survey (note: the survey is now closed).

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) provides advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). A group of advocates, including two from our Association, have been working to develop recommendations regarding the IOM report for CFSAC to consider at its next public meeting (which has not been scheduled at this time). Within this group of advocates there is a wide range of reaction and response to the report, but considering how high the stakes are for patients (worldwide), and the opportunity for moving forward because of this report, the group is working very hard to develop consensus.

What we are doing
Our Association is providing your responses to our survey (individual responses and a summary) to the CFSAC IOM Working Group to consider as they develop preliminary recommendations. We feel that whatever CFSAC recommends to the Secretary of HHS will be given serious consideration and this is a way to include your input in those recommendations.

Our Association also did a survey of Early Onset Symptoms in ME/CFS (March 30 – April 18, 2015), to which 800 individuals responded. Although this was in no way a scientific study, the results showed that the earliest symptoms (as remembered!) were quite heterogeneous. A summary of these results will also be provided to the Working Group, and will be posted on our website.

Other CFSAC news
The Chronic Fatigue Syndrome Advisory Committee has new leadership. With the retirement of Barbara James, Ledia Martinez, MD, MPH has been appointed as the designated federal officer (DFO) of the CFSAC. Dr. Martinez has extensive experience relevant to the work ahead for ME/CFS, in particular coordinating regional health programs, developing training curricula and developing programs to train community leaders, and working with planning councils to resolve issues relating to care and treatment of HIV/AIDS patients.

Pathways to Prevention (P2P) – final report to be released on June 16, 2015
This is the report from the National Institutes of Health which is intended to outline directions for future research for ME/CFS. There has been some controversy about this report, as it was discovered by an advocate that many comments from the public (including those from our Association and from the Chronic Fatigue Syndrome Advisory Committee) were never given to the Committee members for their consideration. This has now been done, and the Committee has met via conference call to consider the comments which were omitted. When the report is released, it should be available at this link: https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/me-cfs.

Research Directions

The End ME/CFS Project 
Open Medicine Foundation (OMF) and top experts under the guidance of world-renowned geneticist Ronald W. Davis, PhD. are launching a bold new project of collaborative research. The ultimate goal is to unlock the mystery of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). “The project will find grants and funding, and determine the most effective course of research. The goal is to understand the disease at a molecular level, finding diagnostic markers, effective treatments, cure and prevention. Basic research will be conducted in the best scientific laboratories. ME/CFS clinicians will provide their intimate knowledge of the disease and conduct any clinical trials. We will work until answers are found.” OMF is a privately and community funded organization. Read more about the project.

Big Data Study for Severely Ill
The Open Medicine Foundation has just published a detailed proposal for the Big Data Study for Severely Ill. This is an ambitious project, and the first time any research of this scope and depth has been done with patients who are severely ill with ME/CFS. Read more about the study.

Finding a Home for Chronic Fatigue Syndrome at the NIH
In order to get a chance at real funding at NIH, the disease needs to be assigned to a real Institute that has money. CFS/ME currently is assigned to office on research on women’s health which has no direct funding. One such home might be the National Institute of Neurological Diseases and Stroke (NINDS). Read about the options.

Research studies

The Theory of Everything: ME/CFS Explained? 
The 4I Hypothesis: A Neuro-Immunological Explanation for Characteristic Symptoms of MyalgicEncephalomyelitis/Chronic Fatigue Syndrome 
In this article, Frank NM Twisk “...depicts the 4I hypothesis, an explanatory model for ME (CFS) with a central role for four types of immunological abnormalities: inflammation, (Th2-predominated) immune activation, immunosuppression, and immune dysfunction. The potential direct sequels of these abnormalities, e.g. increased oxidative and nitrosative stress, (reactivating or chronic) infections, and their possible indirect consequences, e.g. mitochondrial dysfunction, hypothalamic-pituitary-adrenal axis (HPA) axis hypofunction, and cardiovascular dysregulation, can plausibly explain various distinctive symptoms of ME/CFS, e.g. exhaustion, (muscle) weakness, pain, cognitive deficits, a flu-like feeling, and post-exertional malaise.” After explaining each of the “I”s using a diagram, one big chart at the end suggests how all the various symptoms of ME/CFS are interrelated. The article suggests ways this hypothesis can be tested.

Cytokine network analysis of cerebrospinal fluid in myalgic encephalomyelitis/chronic fatigue syndrome 
This research study explores immune exhaustion effects using analysis of cerebrospinal fluid. The comparative study found significant difference in cytokine levels in the cerebrospinal fluid between Multiple Sclerosis (MS) patients and controls, ME/CFS patients and controls, and importantly, between ME/CFS and MS patients. The researchers also identified a unique pattern of immune molecules in the cerebrospinal fluid of people with ME/CFS that provides insights into the basis for cognitive dysfunction—frequently described by patients as "brain fog." These results offer new hope for improvements in diagnosis and treatment.

Distinct plasma immune signatures in ME/CFS are present early in the course of illness
Even though this article is a few months old, it is so important that we are giving it to you again. Researchers at the Center for Infection and Immunity at Columbia University's Mailman School of Public Health have identified distinct immune changes in patients diagnosed with chronic fatigue syndrome, known medically as myalgic encephalomyelitis (ME/CFS). The researchers state: “Analyses based on disease duration revealed that early ME/CFS cases had a prominent activation of both pro- and anti-inflammatory cytokines as well as dissociation of intercytokine regulatory networks. [There were] stronger correlation of cytokine alterations with illness duration than with measures of illness severity, suggesting that the immunopathology of ME/CFS is not static. These findings have critical implications for discovery of interventional strategies and early diagnosis of ME/CFS.

Differences were identified between people sick for fewer than 3 years and more than 3 years (chronic). This is biological evidence that the disease has distinct phases. The findings could help improve diagnosis and identify treatment options for the disabling disorder, in which symptoms range from extreme fatigue and difficulty concentrating to headaches and muscle pain, among many other symptoms.

Difficulties with reading
People with ME/CFS report a range of eye and vision-related symptoms, including hypersensitivity to light, difficulty focusing on images, and slow eye movements. Several papers by Dr Claire Hutchinson, Lecturer in Visual Neuroscience at the University of Leicester in the U.K. and others, shows that problems with eyes and vision are indeed a common feature of the illness. This work was privately funded by ME Research UK and the Irish ME Trust. Read more.

Fibromyalgia News

Hot off the press – Dr. Daniel Clauw explains the central nervous system origins of Fibromyalgia at the American Pain Society. In the keynote speech, Dr. Clauw described Fibromyalgia this way: “Fibromyalgia can be thought of both as a discreet disease and also as a final common pathway of pain centralization and chronification. Most people with this condition have lifelong histories of chronic pain throughout their bodies.”

The Spring 2015 edition of Fibromyalgia Live and Chronic Pain is now online! This free magazine, published by the National Fibromyalgia and Chronic Pain Association, contains a special report, “A Close Look At Fibromyalgia Symptoms,” as well as many other interesting and helpful articles.

Tonix Pharmaceuticals Launches Phase 3 Clinical Trial To Evaluate Experimental Fibromyalgia Therapy Tonix Pharmaceuticals Holding Corp. recently announced the beginning of a Phase 3 clinical trial for its product TNX-102 SL for the treatment of fibromyalgia. The company expects to enroll approximately 500 fibromyalgia patients in 35 clinical centers in the United States. Tonix’s goal with TNX-102 SL is to address fibromyalgia by improving the patient’s sleep quality and consequently mitigate the pain and other disease symptoms. Get more details on the trial, including the locations (20 U.S. states) where you can participate.

What you can do

ME/CFS advocate Bob Miller has just launched a major campaign targeting the NIH and HHS and asking for them to give research funding equality to ME/CFS. Use this email template to advocate for more funding for ME/CFS research from NIH and HHS.

Ways to Get Involved with Massachusetts CFIDS/ME & FM Association

Amazon Smile
Contribute funds to our Association at no cost to you! A portion of the sales price of most items you buy from Amazon.com will be sent to our Association every quarter. To set this up, click on Amazon Smile above or click the Amazon Smile graphic on our home page. Search for Massachusetts C F I D S Association in the charities list, and be sure to put spaces between the letters C F I D S. Then start your shopping from smile.amazon.com.

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