Open Medicine Institute ME-RIT Initiative - Objectives Agreed

[Firestormm]

Quite pleased to say I find it hard to keep up with all these positive developments.

I understand all these now agreed objectives are in need of funding; but there's one hell of a commitment from a large pool of experts.

I can't see this has been posted on the forum before - if it has then apologies - but I think this is a new webpage (edit: it was loaded on 2 December 2012).

Posted previously on ME Association Facebook this morning by Dr Charles Shepherd who is actually part of this Group (which I didn't realise).

Folks were asking about Ampligen - well that's on the cards below - point 4. Rituximab gets pole position.

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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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 olifera, 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.

Backed by an international talent pool:

OMI-MERIT Initiative Signators (in Alphabetical Order)

1. Lucinda Bateman (Fatigue Consultation Clinic & Univ of Utah, UT, US),
2. Allison Bested (Complex Chronic Disease Clinic, Canada),
3. Yenan Bryceson (Karolinska Institute, Sweden),
4. Ron Davis (Stanford Genome Technology Center, CA, US),
5. David Dreyfus (Yale/Private practice, US/Israel),
6. Oystein Fluge (Haukeland University Hospital, Norway),
7. Mady Hornig (Columbia Univ, NY, US),
8. Nancy Klimas (NOVA Univ, FL, US),
9. Andy Kogelnik – Chair (Open Medicine Institute, CA, US),
10. Charles Lapp (Hunter Hopkins Center, NC, US),
11. Jay Levy (UCSF, CA, US),
12. Alan Light (University of Utah, UT, US),
13. Kathleen Light (University of Utah, UT, USA),
14. Sonya Marshall-Gradisnik (Griffith University, Australia),
15. Mauro Malnati (San Raffaele Scientific Institute, Italy),
16. Olav Mella (Haukeland University Hospital, Norway),
17. Jose Montoya (Stanford University, CA, US),
18. David Patrick (Complex Chronic Disease Clinic, Canada),
19. Dan Peterson (OMI and Sierra Internal Medicine, NV, US),
20. Simone Pensieroso (San Raffaele Scientific Institute, Italy),
21. Peter Rowe (Johns Hopkins, US),
22. Charles Shepherd (Private practice, UK),
23. Ila Singh (Mount Sinai School of Medicine, NY, US),
24. Carmen Scheibenbogen (Charité Berlin, Germany),
25. Chris Snell (University of the Pacific, US),
26. Staci Stevens (Open Medicine Institute, US)
27. Rosamund Vallings (Private practice, New Zealand).

I don't know much about this initiative so I'll be reading up on it over Xmas I think. Perhaps this will help overcome some of the disappointment felt following yesterday's decision on Ampligen. Perhaps not. I hope it helps

 

[Stukindawski]

I noticed this one on twitter recently, quite exciting isn't it?

The mere fact that all those researchers got together and hammered out this list is an awesome collaboration.

I'll take this as my ME/CFS world Christmas present

When a road closes, the most important thing is to keep hoping. Nothing can be achieved without hope, and half the challenge is keeping the light of hope alive even in the darkest night.

'What can we do next?' I say

 

[Firestormm]

'What can we do next?' I say

Raise the money?!

 

[Firestormm]

A Community-Based Initiative

OMI is a community-based organization, providing benefits directly to patients, supporting community physicians and hospitals, and contributing to the understanding of disease and treatments. The Institute is a California community benefits corporation (“B corp”)—defined by its focus on delivering value to the community ahead of profits to its shareholders.
OMI has received funding from the CDC to advance research into ME/CFS, and is crowd-sourcing private funds to support diagnostic and treatment trials in the US and internationally. If you believe in the work we’re doing, please consider making a donation.

 

[Sasha]

Some good projects to donate to at the moment - Simmaron, Rituximab, now this...

 

[heapsreal]

wow, looks good.
Have they been getting their ideas from us on phoenix rising??lol.

 

[Sean]

Good news, in no small part because of whose on that list of signators.

 

[equestrian111]

Thanks for posting this. There is light in this tunnel. They are bringing medicine and research into the 21th century by linking info world wide. Very geek...yeah...maybe the Dr of tomorrow will be more informed and interested in learning. No more excuses. One Dr I went to , an allergyst..young I might add. I asked him it I could have mold toxicity. He said no such thing. And emailed me a link to CDC..that said no and maybe . Lots of double talk to cover their asses..If there were online resources for these. docs to see what respected Dr in their field are doing...it might change medicine.

 

[justy]

This is great news!
Looks like a big push coming up all round to find treatment, biomarkers and cause. I cant believe with all this going on as listed above that they wont be able to pin this down. How can anyone doubt the validity of this illness now.
Would be great if we could get this covered in the UK press - show how seriously this is being taken around the world and that they need to step up in the UK.

Justy x

 

[Marco]

Excellent.

One small concern though is that for a condition classified as 'neurological' there appears to be little dealing with neurology?

 

[justy]

Just read through the list of projects as detailed above by Firestormm more slowly and carefully. All i can say is wow! this is really amazing stuff.
I wonder what time spans they have for these projects? Just one or two of these alone would be great, but all of them.
My mind is boggled, but happy.

Justy x

 

[taniaaust1]

I guess the only thing now which will slow all these plans up will be money. It may take them a very long time to achieve all that without A LOT of funding.

It is great to see once again a big group of experts working "together" for us. This is needed.

 

[Chris]

Sounds like a great plan of action--and I happily note that both the Medical and Research Directors of the new (open Spring 2013, maybe..) Vancouver clinic are on the list of participants... hope is in the air...though long rather than short term. I think we should all give contact info to any of our circle who might think of giving us Xmas or birthday gifts--a donation to this outfit would be the nicest present I could think of! Best, Chris