How I would spend 100 M £ Annually on #MECFS #ThereForME

Build a ME/CFS International Diagnostic Blood Test Consortium

Aug 21, 2024

#ThereForME is the creation of Karen Hargrave and Emma Gore-Lloyd, two carers of Severe ME/CFS and LongCovid patients. I am a Severe ME/CFS patient who is bedridden and cannot speak. I have a Bachelor of Journalism with Honours and an unfinished psychology degree. My favourite classes were Research and Methods and NeuroBiology for Psychology. I was diagnosed with ME/CFS in 2001. I was diagnosed by Dr. Anil Jain, MD. The 2nd author of the Canadian Consensus Criteria. I have become deeply interested in the Science of ME/CFS and these are my thoughts on how I would spend 100 Million pounds on Solving ME/CFS if I had the money and influence to do so.

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Build an International ME/CFS Diagnostic Blood Test Consortium

When we think of transformative moments in medicine and science, a description of a human being objectively measuring something for the first time occurs immediately after. For Multiple sclerosis (MS) patients it was the MRI that transformed MS from a clinical diagnosis to an objectively based MRI-based diagnosis that in turn transformed both the view of medical professionals and the public’s view of MS patients.
We see a similar story in HIV/A.I.D Syndrome where the patient population is deeply discriminated against and an HIV test that acts as a blood screen for the blood supply acts as a catalyst to transform HIV research into a Billion-dollar-a-year research endeavour.
Both Parkinson’s disease and Alzheimer’s disease are now poised to make similar leaps. When I took a Health Psychology class in 2007, my textbook said that an Alzheimer’s diagnosis could only be confirmed by autopsy. So much progress made!
I am personally quite envious of Michael J Foxe’s Parkinson’s Progressive Marker Initiative which put together the financing and infrastructure to pursue a single goal of a Parkinson’s marker.
I am equally envious of the group that tested 1200 Alzheimer’s samples against spinal trap and brain scan.
To see 1200 samples of ME/CFS blood tested for proteins - that would indeed be a dream come true.
We know that this type of diagnostic blood test moment has to happen for ME/CFS and LongCovid if ME/CFS and LongCovid are ever going to make that leap as well.

The Why
Why do we need an International Diagnostic Blood Test Consortium?

ME/CFS blood is banned for donation in 5 countries: Canada, the United Kingdom, Ireland, New Zealand and Australia. Canada was the first country to ban blood donation by ME/CFS patients in 2010, but 14 years later there exists no investment by any of these 5 governments in a diagnostic blood test to ensure the safety of the blood supply for blood transfusion patients. How can we know the blood supply is safe when there exists no proper screening tool for ME/CFS? How these blood services have been screening for ME/CFS eligibility is going to be a future hot topic. We can’t know if the ME/CFS blood is safe or not if we are not actively searching to find out the answer to the question.
A diagnostic blood test is the only thing that will stop the detainment of ME/CFS patients in psychiatric wards, stop the abuse and gaslighting of ME/CFS patients, and stop the fatal neglect of ME/CFS patients in hospitals from starvation. None of these things should be occurring to ME/CFS patients at all. But only the transformative moment of an ME/CFS diagnostic blood test will push true and lasting change in all the medical corners that don’t read Translational Medicine and Nature - or don’t believe what they read.
Successful clinical trials require diagnostic biomarkers and prognostic biomarkers. Drug companies need to have objective markers for entry and endpoints to their studies. It’s what makes their studies more likely to succeed. The fight for ME/CFS and LongCovid treatment is not the fight for treatment. The fight for treatment is the fight for funding and legislation for diagnostic and prognostic biomarkers for ME/CFS and LongCovid that will make clinical trials successful and bring in Pharma funding.
For FDA votes for Treatments. In 2012, Ampligen, a pharmacological treatment for ME/CFS went in front of the FDA for approval and was voted down because those who voted could not be certain a patient was a patient without a blood test for the patients. So much time and progress has been lost because of that single vote. Both ME/CFS and LongCovid patients will face that same disappointment in front of the FDA if we don’t seize the moment and push a diagnostic blood test into the world. In every room, at every table of power and decision making are groups of people in science and medicine who are misinformed about ME/CFS. They carry unscientific opinions and biases spoonfed to them by professionals with Corporate agendas. They will ignore all science and medicine that does not fit their biased view of ME/CFS and ME/CFS patients that they have been misled to believe. Only the blood will convince them. That’s what the FDA said in 2012, and there’s no reason to believe 2024 and beyond will be any different. FDA wants a blood test - so let’s give them one.
Educate Medical Professionals. We want Doctors to be educated on ME/CFS and LongCovid. We want doctors to be able to diagnose and treat ME/CFS according to our symptoms with off-label treatments and preferably someday with FDA-approved treatments. We need a ME/CFS diagnostic blood test to make that occur faster. Once the medical community knows ME/CFS can be diagnosed easily and treated with something- they will come. We need a diagnostic test and FDA-approved treatments so that all ME/CFS patients can be diagnosed and treated. We need to be able to wave a ME/CFS diagnostic test in the face of doctors and psychiatrists so that people like Maeve Boothby-O’Neill can live.

Everything a ME/CFS patient needs from diagnosis to treatment is tied directly to the success of a ME/CFS diagnostic blood test being approved for use in their country.

1 Objective Marker and 4 Potential Diagnostic Blood Tests

The state of play in ME/CFS diagnostics is that ME/CFS has 1 objective marker - the 2-day CPET. However, the 2-Day CPET is expensive, inaccessible, and invasive in the sense that ME/CFS patients may not recover from the provocation of damage from Post-Exertional Malaise (PEM) - the cardinal symptom of ME/CFS. The 2-Day CPET was pioneered by an ME/CFS patient - Staci Stevens, MA and the people who pioneered it are taking every precaution possible to ensure the safety of ME/CFS patients.
However, every ME/CFS patient taking part in a 2-Day CPET provocation study is sacrificing themselves and we must demand that a 2-Day CPET test be used to bring about the conditions so that their sacrifice for research is worth it for all the patients that come after them.
The 2-Day CPET is recognized by the Institute of Medicine (2015) and by disability insurance companies. It is ideal to cross-validate any potential diagnostic blood test like the Alzheimer’s blood test cross-validated their blood test against lumbar puncture and brain scan.
The 2-Day CPET is accepted by disability insurance as an objective measure of ME/CFS - but many patients are not well enough to use it, suffer permanent damage from it, or it is too expensive and inaccessible to them where they live.
Rising from the 11,000 papers on the biological differences between ME/CFS patients and healthy controls are 4 diagnostic blood tests in development.

Leading is 11 MicroRNAs from the Lab of Dr. Alain Moreau which can stratify both ME/CFS and LongCovid patients into clusters with PEM provocation using a massaging Cuff and HexoSkin to take many objective measurements. MicroRNAs are leading because they are the easiest to translate to the clinic from the research lab. (Nepotchatykh, E. et al, 2020, 2023) (Petre, D et al, in Preparation) As an aside, ME/CFS has long been mistakenly associated with Depression (MDD) and General Anxiety Disorder (GAD). Both diseases are also pursuing MicroRNAs as biomarkers -and both diseases have differing MicroRNAs from ME/CFS in separate studies of each disease. Whether those results would hold up in a larger study of all 3 diseases in a MicroRNA faceoff of ME/CFS vs MDD vs GAD vs Healthy Controls using a well-characterized patient cohort based on a 2-Day CPET AND Moreau’s Cuff/Hexoskin only a funded study in the future could tell us.
Raman Spectroscopy from the lab of Dr. Karl Morten at Oxford University. (Xu, Jiabao, et al, 2019, 2023). Studies have shown that Raman Spectroscopy can differentiate ME/CFS from Healthy Controls and MS patients. Raman Spectroscopy is not easily transferable to the clinic for testing but advancements in Raman Spectroscopy to measure many different diseases could mean it has a bright future.
Electrical Impedance. In 2019, the Lab of Dr. Ron W Davis at the Genome Centre at Stanford University published an Open Medicine Foundation-funded study of an NIH-funded device called the Nanoneedle that was originally meant to measure proteins in cancer patients. In a small study, the investigators were able to measure well-characterized ME/CFS patients with 100% accuracy after a salt stressor was added to the cells to mimic PEM provocation from exercise. The results held up in unpublished data. Further experiments showed that the signal from the Nanoneedle could be adopted by healthy cells in ME/CFS plasma. The NIH, always being 20 steps behind the real-world scientific needs and 600 Million dollars short denied funding for further development studies that could have measured the specificity and sensitivity in measuring ME/CFS patients. The Nanoneedle was also poised to be a drug screen, and why the NIH would deny a potential diagnostic test and drug screen for treatments while the Covid19 pandemic increased the number of ME/CFS patients to 5 to 9 million Americans is something Congress can puzzle over. 4 years later, researchers at the University of Surrey funded by MEResearchUK and ME Association are now testing the electrical properties of ME/CFS white cells in a new robust approach.
In January 2024, LaTrobe University announced that the Mason Foundation was funding a new diagnostic blood test.

The How - Getting to ME/CFS and LongCovid diagnostic blood tests

We need to build an International Diagnostic Blood Test Consortium whose only goal is to fund, legislate, research, and get approved ME/CFS and LongCovid diagnostic blood tests and prognostic biomarkers for every subgroup of ME/CFS/LongCovid so that no one is left behind.
ME/CFS patients and LongCovid patients need to be stratified and important experiments repeated. I would love to see the recent LongCovid mouse studies which involved LongCovid purified IgG being transferred to mice to be tested by using Dr. Alain Moreau’s 11 MicroRNAs. To stratify ME/CFS and LongCovid patients into clusters based on MicroRNAs and Random Forest Analysis, and then have each group cluster transferred to mice and see how the mice fare. This type of precision of stratifying ME/CFS and LongCovid patients before doing such amazing experiments as IgG transfer can only benefit elucidating autoimmune mechanisms of ME/CFS and LongCovid quicker.
We need to build large cohort studies that will get us to YES from the FDA for a diagnostic test and a YES for treatments.

I propose that the 100 Million Pounds be spent on a Consortium tasked with:
A ME/CFS and LongCovid biomarker protocol that outlines which definitions, diagnostic criteria, and objective markers will be used to identify ME/CFS and LongCovid patients to be used uniformly in biobanks and future biomarker discovery. We cannot rely on self-reporting. As an ME/CFS patient, I would say that a patient can be trusted. But the person reading the study will not, and it’s the unconvinced we need to reach. We need to make the entry into the studies using objective markers mandatory. It’s the only thing that will make them ironclad and believable. We need to use the existing objective elements we have to objectively identify ME/CFS patients in biomarker protocols to strengthen the discovery and approval of ME/CFS and LongCovid diagnostic blood tests while ensuring the safety of ME/CFS and LongCovid patients.
An International ME/CFS and LongCovid Diagnostic blood test Roadmap that maps what we know, and what we don’t know, and also what elements are required for large Cohort studies and the FDA/CIHR/NHS approval process for diagnostic blood tests. We need a map so that all researchers can see what needs to be done to get us from Point A to Point B where X marks the spot. We need researchers to agree to the protocol first so it can be applied to the Roadmap. The Consortium needs to set out criteria and experimental design for large cohort studies to cross-validate ME/CFS diagnostic blood tests with 2-Day CPET as quickly and as safely as possible.
An investment in ME/CFS bio and tissue banks that are set up according to the ME/CFS biomarker protocol containing samples from ME/CFS patients that have diagnoses based on mandatory objective testing. Have the facilities collect and study ME/CFS spinal, brain, muscle biopsies, blood, and menstrual blood for immune and metabolic markers and to test hypotheses in viral persistence, viral reactivation, autoimmunity, and T-Cell and B-Cell Immunology.
A Data Centre dedicated to the collaboration and mapping of ME/CFS and LongCovid diagnostic blood test research that meets the criteria of the ME/CFS diagnostic blood test biomarker protocol and research from the Bio and Tissue banks that are also run according to the protocol and roadmap.
Bi-annual Conferences dedicated to ME/CFS and LongCovid diagnostic blood tests. Public and Private meetings and presentations between researchers funded by the ME/CFS Diagnostic Blood Test Consortium to stay updated on the latest progress in their experiments, update progress on the biomarker protocol and roadmap and foster collaborations between researchers to cross-validate findings and move faster towards consensus and approval of a ME/CFS and LongCovid Blood Tests.
Create a panel of ME/CFS biomedical researchers, ME/CFS patients, and Biomarker experts from other diseases to sit on a diagnostic blood test approval committee to work with existing biomarker protocol and roadmap. We need the expertise of HIV biomarker departments to guide us. The panel has to be a blueprint for a future ME/CFS Biomarker department in a University.
The Consortium must create a ME/CFS/LongCovid joint patient wing (that includes Severe ME/CFS patients that can still communicate in writing) whose final approval will be required for every study funded by the Consortium. This will save money being wasted from psychiatric creep couched in biological terms. Patients don’t live with research silos.
Fund independent validation and Replication Studies of successful diagnostic tests.
Fast track ME/CFS diagnostic test approval with various governing bodies

A future ME/CFS diagnostic blood test Consortium must fund well-designed large cohort studies and ensure that an ME/CFS diagnostic blood test is fast-tracked for approval.

One can only guess why the NIH did not do what I have outlined with the 100 Million dollars earmarked for diagnostics in the 1 Billion dollars for LongCovid.
Successful clinical treatment trials require both diagnostic and prognostic biomarkers and any government organization (NIH, CDC) claiming to want clinical trials for ME/CFS and LongCovid that is not actively funding any of the 4 above potential diagnostic tests and not using the 2-Day CPET is not reaching for a successful clinical trial for ME/CFS and LongCovid.

ME/CFS is measurable in the research lab. Let’s make it measurable in the clinic. Let’s get a ME/CFS diagnostic blood test into every clinic in the world so that mobile nurses can get it to the homes of the bedridden ME/CFS and LongCovid patients and so we can restore proper humane medical treatment for ME/CFS patients.

With gratitude to Karen and Emma at #ThereForME for inspiring me to write down what I think about all day, every day.