Community Support Moves Severely Ill Chronic Fatigue Syndrome (ME/CFS) Study Forward Rapidly
About two weeks ago the Open Medicine Foundation scored a $500,000 donation to expand Ron Davis's severely ill chronic fatigue syndrome (ME/CFS) study. Just two days later a $224,000 donation rolled in. Things are looking up for the severely ill project.
Ron Davis et. al. are working fast to take advantage of the funding. The money will allow them to expand their testing regimens and bring in more help. He's targeting some experts in the field, one of whom he said consistently produced "unbelievably reproducible" results. That's the kind of thing that gets Ron Davis excited . (Researchers think differently )
First, Davis had to figure out how to preserve and process incredibly delicate samples away from a hospital setting. He devised a mobile processing unit that willl be used to process the samples of seriously ill patients who are not close enough to a suitable processing facility.
Now that that's done and they're able to bring on more assistants they anticipate the expanded study will be done within the year. That's very fast for a research study and indicates the urgency with which they are working. It also indicates that private funding can move our understanding of this disease forward the most quickly.
[fright]
[/fright]To get comparable support from the NIH would take doing a pilot study (1 year?) to get some data for the grant proposal, writing up the grant (6 months), applying for the grant (6 months) and then getting the money for the grant (6-12 months).
It can take several years before a researcher can actually start working on an NIH grant. The OMF, on the other hand, has been able to raise $1.75 million in about six months. They started preparing for the study before they started raising money for it. Now that they have the money - they're hitting the road running...
The OMF is also doing "out of the box" type research that the NIH doesn't particularly like funding. A fairly conservative institution, the NIH doesn't usually support "fishing expeditions" like the Davis project which is essentially looking in every molecular nook and cranny it can for the answer to ME/CFS.
Stanford immunologist Mark Davis explained to me, though, that fishing expeditions are exactly what you need in field like chronic fatigue syndrome where so little research has been done. A comprehensive a look at ME/CFS could cut years off a normal research path if it comes up unusual, unanticipated findings.
Unusual Tests Could Bring New Understanding
The ability of this study to open up new ground is, of course, why it's so tantalizing.
I asked Davis about some of the tests being done.
It takes too long for new treatments to come to market. Once Davis discovers which pathways are the problem his first task will be to scan the 1,000's of drugs on the market to see which could impact it. He noted that drugs now being used for entirely different purposes could be helpful.
Freeing the Data
[fright]
[/fright]Davis has one thought: to understand ME/CFS as quickly as possible. To do that he knows as as many minds grappling with ME/CFS the better. To that end he's going to do the unthinkable in some research circles: he's committed to posting the results from the tests on the internet within 24 hours of getting them. (The Human Genome Project did the same thing.).
Given the enormous data that is going to be generated by this project that's a great idea. Finding ways to make sense of it and create hypotheses regarding what is going on in ME/CFS is going to be a huge job. The more hands on deck the better.
Ambitious Study Rewarded
Ron Davis's and the OMF's success at raising money also suggests that big, ambitious, backed by reputable researchers can elicit big contributions from the ME/CFS community and its supporters. Community support can clearly jump start good studies that could take years otherwise to get funded at the NIH - if they do at all.
Given these difficult budgetary times the NIH's support is uncertain, anyway, and competition between researchers is fierce. Davis told me that the fate of a grant proposal depends on the makeup of the grant review panel - and you never know who is going to be on one.
The OMF Announcement
How this big donation will help:
With these new funds, we have increased the types and number of tests that will be included in the OMF ME/CFS Severely Ill-BIG DATA Study. This study will give us a thorough, deep-dive and comprehensive molecular profile of severely ill ME/CFS patients..
More details of the tests included will be forthcoming. This study has now been launched and will take 9-12 months.
Research Tests
About two weeks ago the Open Medicine Foundation scored a $500,000 donation to expand Ron Davis's severely ill chronic fatigue syndrome (ME/CFS) study. Just two days later a $224,000 donation rolled in. Things are looking up for the severely ill project.
Ron Davis et. al. are working fast to take advantage of the funding. The money will allow them to expand their testing regimens and bring in more help. He's targeting some experts in the field, one of whom he said consistently produced "unbelievably reproducible" results. That's the kind of thing that gets Ron Davis excited . (Researchers think differently )
First, Davis had to figure out how to preserve and process incredibly delicate samples away from a hospital setting. He devised a mobile processing unit that willl be used to process the samples of seriously ill patients who are not close enough to a suitable processing facility.
Now that that's done and they're able to bring on more assistants they anticipate the expanded study will be done within the year. That's very fast for a research study and indicates the urgency with which they are working. It also indicates that private funding can move our understanding of this disease forward the most quickly.
[fright]
It can take several years before a researcher can actually start working on an NIH grant. The OMF, on the other hand, has been able to raise $1.75 million in about six months. They started preparing for the study before they started raising money for it. Now that they have the money - they're hitting the road running...
The OMF is also doing "out of the box" type research that the NIH doesn't particularly like funding. A fairly conservative institution, the NIH doesn't usually support "fishing expeditions" like the Davis project which is essentially looking in every molecular nook and cranny it can for the answer to ME/CFS.
Stanford immunologist Mark Davis explained to me, though, that fishing expeditions are exactly what you need in field like chronic fatigue syndrome where so little research has been done. A comprehensive a look at ME/CFS could cut years off a normal research path if it comes up unusual, unanticipated findings.
Unusual Tests Could Bring New Understanding
The ability of this study to open up new ground is, of course, why it's so tantalizing.
I asked Davis about some of the tests being done.
- Microbiome Test - This test, which could conceivably be done in Ian Lipkin's lab, will examine the constituents of the gut flora. Lipkin and Hornig, of course, are working on their own microbiome analysis of mostly healthier patients. Comparing the gut flora found in the two groups would be fantastic and could help us understand why some patients just get sicker and sicker while others are able to maintain some health.
- Immune Tests Galore - Earlier we heard that Mark Davis was using his big immune machine to look at ME/CFS samples. At at an End ME/CFS event, however, he said that was never done. Well, it's being done now. Ron said he will give Mark Davis a free hand with his uber immune testing machine to explore immune functioning in the severe ME/CFS patients. (When asked why he was playing such an active role in the project, Mark Davis said "When Ron Davis asks you to do something you do it" ).
- Natural Killer Cell Expert On Board - Ron said Mark Davis's team was blessed by the presence of Katherine Bliss - a natural killer cell expert. She will be taking a deep look at NK cells including possibly- if I got it right - developing a better test. Davis also noted that Dr. Klimas's findings suggest that the NK cells may not be the problem so much as something in the blood that is whacking them. He suggested that something could even be turning off their mitochondria. Finding out what that might be won't be easy but he's going to give it a try.
- Antibody Study - a new antibody technique will be able to tell every pathogen the patients have ever been exposed to.
- EBV - there's a whole swarm of interesting Epstein-Barr Virus tests that I've never heard (EBVA EA Uric Acid, EBVA NA Copper, EBVA VCA Biotin (Vit. B7)-serum)
- Bartonella/ HSV - I don't if either of these pathogens have ever been tested in ME/CFS before. Dr. Kaufman at the OMF has evidence suggesting that Bartonella may be a major player for some patients.
- Mitochondrial Testing - Many mitochondrial tests are being done (Lactate HbA1C, Organic Acids-urine Ammonia, Acylcarnitines Whole Exome Genome, Pyruvate Mitochondrial Genome, CK Mitochondrial MT;NL Ratio
- Metabolomics - citing Ron Tompkins - a member of the End ME/CFS Project advisory board, Davis stated that "the blood is the sewer of the body"; i.e. just about everything ends up there. Studying the proteins present in the blood in the metabolomics part of the study, could tell us a lot, therefore about what has gone wrong.
- Autoantibodies - Davis is particularly interested in autoantibodies to mitochrondrial proteins and may use Lasker award winner (and ME/CFS researcher) Steven Elledge's lab at Harvard to study these (and others).
It takes too long for new treatments to come to market. Once Davis discovers which pathways are the problem his first task will be to scan the 1,000's of drugs on the market to see which could impact it. He noted that drugs now being used for entirely different purposes could be helpful.
Freeing the Data
[fright]
Given the enormous data that is going to be generated by this project that's a great idea. Finding ways to make sense of it and create hypotheses regarding what is going on in ME/CFS is going to be a huge job. The more hands on deck the better.
Ambitious Study Rewarded
Ron Davis's and the OMF's success at raising money also suggests that big, ambitious, backed by reputable researchers can elicit big contributions from the ME/CFS community and its supporters. Community support can clearly jump start good studies that could take years otherwise to get funded at the NIH - if they do at all.
Given these difficult budgetary times the NIH's support is uncertain, anyway, and competition between researchers is fierce. Davis told me that the fate of a grant proposal depends on the makeup of the grant review panel - and you never know who is going to be on one.
The OMF Announcement
$500K Special Announcement!
It’s happened again! A very generous anonymous donor has expressed confidence in Open Medicine Foundation (OMF) research by donating $500,000 to expand the OMF ME/CFS Severely Ill Big Data Study.
As you may recall, just a few months ago, we reached our goal of $1 million to do the Severely Ill-BIG DATA Study, which is Phase 1 of the End ME/CFS Project. How this big donation will help:
With these new funds, we have increased the types and number of tests that will be included in the OMF ME/CFS Severely Ill-BIG DATA Study. This study will give us a thorough, deep-dive and comprehensive molecular profile of severely ill ME/CFS patients..
More details of the tests included will be forthcoming. This study has now been launched and will take 9-12 months.
Thank you to all of our supporters!
Complete Test List
Research Tests
- RNA Gene Expression - PBMCs
- RNA Gene Expression - NKs
- RNA Gene Expression - Monocytes
- RNA Gene Expression - T-Cells
- RNA Gene Expression - B-Cells
- RNA Gene Expression - Macrophages
- RNA Gene Expression - Dendritic Cells
- MicroRNA in Plasma
- Proteomics
- Cell-Free DNA
- Whole Genome Sequencing
- Whole Exome Genome Sequencing
- Mitochondrial Genome Sequencing
- Mitochondrial DNA/Nuclear DNA Radio
- HLA DNA Sequencing
- WBC density
- Autoantibody panel
- T-cell Repertoire DNA Sequencing-Stanford
- T-cell Repertoire DNA Sequencing-Sequenta
- CyTOF Standard Panel
- CyTOF Additional Panels
- Pan Viral Panel
- Serum Cytokines
- Ceres Nano Lyme
- Microbiome - stool
- Metabolomics - stool
- Metabolomics - plasma
- Metabolomics - urine
- Heavy Metals - blood
- Heavy Metals - urine
- Mycotoxins by Magarray
- Acylcarnitines
- Ammonia
- Bartonella extended cx
- Biotin (Vitamin B7)
- CBC (Complete Blood Count)
- Chemistry Comprehensive Panel
- Creatine Kinase
- Copper
- C- Reactive Protein
- Cysteine
- Folate
- FSH (Follicle-Stimulating Hormone)
- LH (Luteinizing Hormone)
- Estrogen
- HbA1C (Hemoglobin A1c)
- Homocysteine
- IgG Subsets
- Lactate
- Lyme Serology with reflex Western Blot
- Lymphocyte Subsets
- MMA (Methylmalonic Acid)
- MTHFR Mutations (Methylenetetrahydrofolate)
- Natural Killer Cell (Count & Function)
- Organic Acids - urine
- Pyruvate
- Serotonin
- Testosterone
- Thyroid Panel
- Uric Acid
- Vasopressin/ADH
- Viral Digital PCR
- EBV EA (Epstein Barr Virus EA)
- EBV NA (Epstein Barr Virus NA)
- EBV VCA (Epstein Barr Virus VCA)
- CMV (Cytomegalovirus)
- HHV-6 (Human Herpesvirus 6)
- Parvovirus
- HHV-7 (Human Herpes Virus 7)
- HSV1&2 (Herpes Simplex 1 & 2)
- Vitamin B12 (Cobalamin)
- Vitamin D25 OH
- Extended EEG
- Sleep monitoring
- Fitbit
- Cognitive Testing
- Questionnaires - SF36, PROMIS
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