Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)
ME/CFS is a debilitating disease affecting neurologic function, metabolism, hormonal regulation, circulation/blood pressure, and overall well being. ME/CFS affects over 8 million patients worldwide. It has few options for accurate diagnosis and treatment.
Patients with ME/CFS desperately need answers. We are convinced these answers are readily available if we apply the best resources in a large-scale, concerted effort. Bringing together the right experts and the most advanced technologies to deliver actionable results is a necessary condition for success that has been a long time coming to this field.
The OMI-MERIT Initiative—Changing the Game for ME/CFS
OMI-MERIT (ME Roundtable on Immunology and Treatment) is a strategic initiative of OMI and its collaborators to bring together leading clinicians and researchers to tackle this debilitating but underserved disease. The MERIT group is focused on developing and applying a multi-factorial approach to the discovery of new diagnostic and treatment solutions for ME/CFS.
In June 2012, OMI convened an initial group of game changers to advance and prioritize the conversation around urgently needed treatments for ME/CFS. We invited engaged, established scientists and physicians to a two-day session with the goal to address practical issues and identify achievable targets in ME/CFS with a focus on research projects that deliver results for patients in the shortest amount time. We continue to expand the list of OMI-MERIT collaborators and hope to add additional projects as funds allow.
OMI-MERIT Priority Projects
- Treatment: Phase 1: A Large-scale, Randomized, Placebo-controlled Trial of Rituximab and Valgancyclovir
- Goal: This rigorous, four-armed study will examine and further validate two of the most promising therapies in the field by comparing placebo, rituximab alone, valgancyclovir alone, and combination therapy of valgancyclovir plus rituximab. Measurements of physiologic, genomic, virologic, and immunologic markers will be made throughout the course of the trial.
- Importance: A large-scale, rigorous trial is needed to confirm the initial findings of earlier smaller studies and move ME/CFS to a molecularly trackable disease. Success of such a trial could move ME/CFS to a mainstream process for additional diagnostic and treatment trials.
- An International Neuro Registry and Biobank
- Goal: Supporting and expanding the largest and most comprehensive longitudinal ME/CFS information source for research and collaboration will be the result of this project. We will collect longitudinal data and biological specimens from ME/CFS patients and controls, and characterize the ME/CFS population by patient symptoms and laboratory and molecular profiles through crowd-sourced informatics and cutting-edge tools in immunology, genomics, and molecular biology. Comprehensive, standardized sampling will include blood, cerebrospinal fluid (CSF), urine, stool, brain/CNS, and other tissues. Samples will be available for additional studies in the MERIT list and beyond.
- Importance: There has been no large-scale, chronologic characterization effort across the ME/CFS population. The Registry and Biobank will help establish clinical and biologic clusters in the population, paving the way for diagnostic biomarkers and cluster-specific treatments. In addition, this will provide a community resource for patients and is central to additional collaborative projects.
- Protein Panel in Treated and Untreated Patients
- Goal: Performing in-depth, cutting-edge protein analysis of selected specimens from the Biobank to identify bacteria, viral, hormonal, antibody, cytokine, and other protein-based substances that might be present in patient specimens. Specimens will be selected based on expected yield from clinical data and then discoveries confirmed in the larger patient population.
- Importance: This project aims to apply cutting-edge protein detection systems with specific, ultra-sensitive ME/CFS-related targets identified. Protein markers are key in identifying potential biomarkers, and many new advanced technologies have never been applied to ME/CFS before.
- Treatment: Phase 2: Other Therapy Mono and Combination Pilots
- Goal: To assess the effect of other touted treatments that are currently available in the field and establish immunologic and molecular parameters for measuring the efficacy of such treatments. Treatments assayed will include Ampligen, Etanercept, rifaxamin, Issentris, famcyclovir, and possibly others.
- Importance: To determine a direction and baseline for other potential drug therapies in the field and assess which should receive additional allocation of funds for research.
- Immunologic Biomarker Exploration Studies
- Goal: These exploratory studies will examine B-cell, T-cell, and Natural Killer cell responses to disease and treatment groups using comprehensive, rigorous methods, many of which have never before been applied to ME/CFS. It will seek to establish immunologic baselines and variants from that across the patient population.
- Importance: For a disease that appears to have a solid immunologic component to it, this study will provide the most advanced, longitudinal characterization of immune changes in critically implicated cells over selected treatment and control patients.
- DNA Genetics
- Goal: Use the most advanced methods to sequence key areas of the human genome in a set of patients, controls, affected families, and unrelated individuals. Utilizing advanced Human Genome Project technologies, this project will undertake HLA and other regional sequencing of areas of interest for selected patients and families.
- Importance: Establishing or refuting a role for genetics and potential heritable risk in ME/CFS.
- Mass Spectroscopy/Environmental Measurements
- Goal: This exploratory study will search patient samples for unknown compounds, toxins, proteins, and other substances that may be implicated in the genesis of the disease or otherwise contribute to immune dysfunction.
- Importance: This would be the first systematic examination of samples by the most reliable substance identification techniques to begin to establish an understanding of the contribution of nutritional and environmental factors to ME/CFS.
- Comprehensive Viral Testing
- Goal: Establish a core of viral testing methodologies that are useful and could be useful clinically. Testing will include blood, urine, saliva, and other tissues where available for specific viruses such as EBV, HHV6, CMV, Parvovirus, HSV1, and HSV2, and additional panel-type testing for novel viral identification and high throughput methods.
- Importance: This project will set the standard for clinical viral testing in ME/CFS and establish a guideline for evaluation and treatment directions for patients. Priority will be given to assays that have already yielded promising clinical results in partner labs.
- Advanced Immunologic Biomarker Study 2
- Goal: This secondary immune study will look at additional cell types that complement project #5 above, such as monocytes, macrophages, and dendritic cells.
- Importance: This study extends our immunologic understanding of the disease and its extent.
- Treatment: Phase 3: Natural and Over-the-Counter Substances
- Goal: Examine the potential benefit of several over-the-counter/natural therapies in a vetted scientific setting. Substances examined will include Moringa oliefera, GcMAF, Vit B12, and artemesin.
- Importance: This project will be a first application of vetted scientific method and molecular science to non-pharmacologic substances that have had anecdotal benefits reported, thereby setting a standard for mainstream measurement of ME/CFS.
OMI-MERIT Initiative Signators (in Alphabetical Order)
Lucinda Bateman, MD (Fatigue Consultation Clinic & Univ of Utah, UT, US)
Alison Bested, MD (Complex Chronic Disease Clinic, Canada)
Yenan Bryceson, PhD (Karolinska Institute, Sweden)
Ron Davis, PhD (Stanford Genome Technology Center, CA, US)
David Dreyfus, MD, PhD (Yale/Private practice, US/Israel)
Oystein Fluge, MD (Haukeland University Hospital, Norway)
Mady Hornig, MD, PhD (Columbia Univ, NY, US)
Nancy Klimas, MD (NOVA Univ, FL, US)
Andy Kogelnik, MD, PhD – Chair (Open Medicine Institute, CA, US)
Charles Lapp, MD (Hunter Hopkins Center, NC, US)
Jay Levy, MD (UCSF, CA, US)
Alan Light, PhD (University of Utah, UT, US)
Kathleen Light, PhD (University of Utah, UT, USA)
Sonya Marshall-Gradisnik, PhD (Griffith University, Australia)
Mauro Malnati, MD, PhD (San Raffaele Scientific Institute, Italy)
Olav Mella, MD (Haukeland University Hospital, Norway)
Jose Montoya, MD (Stanford University, CA, US)
David Patrick, MD, PhD (Complex Chronic Disease Clinic, Canada)
Dan Peterson, MD (OMI and Sierra Internal Medicine, NV, US)
Simone Pensieroso, PhD (San Raffaele Scientific Institute, Italy)
Charles Shepherd, MD (Private practice, UK)
Ila Singh, MD, PhD (Mount Sinai School of Medicine, NY, US)
Carmen Scheibenbogen, MD (Charité Berlin, Germany)
Chris Snell, PhD (University of the Pacific, US)
Eleanor Stein, MD (Private practice, Canada)
Staci Stevens (Pacific Fatigue Lab, US) and
Rosamund Vallings, MD (Private practice, New Zealand).
We are adding more all the time. If you are a physician or researcher and want to join us, please contact the OMI.
CDC CFS Characterization Project
The CDC has selected the OMI clinical research network for support of its major effort into better diagnosing and understanding ME/CFS. We have just completed the first year of this project, and the CDC is hoping to extend this project for up to five years.