A bright, bright light is about to shine on the most severely ill among us. The first part of the ME/CFS Severely Ill Big Data Study has been fully funded. It didn’t take long. The Davis’s kicked off a funding drive for the Severely Ill project about a month ago at their home. A couple of days later they received a $500,000 donation in the mail. (Imagine opening THAT letter….How does a $500,000 donation come? In the form of $500,000 check.). The Open Medicine Foundation just announced that that, plus other donations, plus a check for $350,000 dollars gave a green light to the ambitious, million dollar project.
The Davis Group will be digging deep, deep, deep into the biology of severely ill patients.
The project will undertake an exhaustive search for molecular biomarkers in home and/or bedbound patients with ME/CFS. Each patient will receive approximately $25,000 worth of tests. By the time this study is done it’s likely that no patients in any other disease will have received the amount of study these patients will have.
I asked Stanford’s top immunologist, Mark Davis, about this big search effort for biomarkers. He said that the NIH – a hypothesis driven institution – doesn’t get the idea of a big open-ended search effort like this, but that he thought this was the way to go in an under-researched field like ME/CFS.
A study like this – if successful – could cut years, decades even, off the search for the cause of ME/CFS. It could uncover factors never contemplated before, or it could highlight areas we know about, or both. It faces some challenges – lots of measures in a small group of patients, and sorting out the confounding issue of immobility- but then again it has Ron Davis and his group of top researchers. Mark Davis said – when Ron asks you to do something – you do it :).
Davis recently developed the first way to cheaply and accurately assess the HLA part of our genome, and he’ll be developing other ways to do tests in these homebound patients.
It’s a bold effort and that boldness, plus the strength of the Davis team and Linda Tanenbaum’s work to get the message out have succeeded – and quickly. That’s good news for the ME/CFS Community.
This is just the beginning thrust of the End ME/CFS search effort. Davis has proposed the federal government adopt a strategic approach to ME/CFS – something along the lines of what happened with the Human Genome Project. This consortium based effort to understand ME/CFS would cost around $5 million/year.
Janet Dafoe, Ron Davis’s wife, recently tweeted that Davis is committed to apply at every NIH session for funds to study this illness.
The ME/CFS Stigma Project
Davis’s inability to get funding for the severely ill project turned out to be a head-cringingly, embarrassing moment for the NIH. That episode, which suggested the reviewers hardly took the time to read the grant, suggested the stigma surrounding ME/CFS is alive and well in some parts of the NIH.
John Kim, a marketing and advertising professional (and friend of Whitney Dafoe, Ron and Janet’s severely ill son) wants to help out. He’s asking people with ME/CFS to talk about the stigma’s they face at home, in the workplace, in doctor’s offices in order to help him produce more effective awareness and fundraising campaigns.
You help him out with this project by telling him about the stigma’s you may have encountered here.
The Big Biomarker Search
Genomic Biomarker Search
- Whole Genome sequence – Exome DNA sequence, Mitochondrial DNA sequence, Cell free RNA and DNA, DNA methylation of all immune cells
- Metabolomics – Saliva, Urine and Feces
- Saliva – Whole Genome sequence
- Feces – DNA sequence of microbes Metabolomics
Immune Biomarker Search
Blood: Isolation of individual immune cell types. Especially NK cells, Cy-TOF of many immune cell types, Karyotype of immune cells, measure cytokine levels, NK cell activity and gene expression
Novel Biomarker Search
Ultimately the biomarkers – should they appear – could include findings from several different systems ( e.g. proteins in the blood, metabolites in the urine, DNA polymorphisms, epigentic changes) which put together spell ME/CFS. In a recent talk Ron Davis noted that some of the results from his son Whitney’s metabolomics tests were off the charts. That’s the kind the thing they hope will pop out.
Blood: HLA DNA sequence, KIR DNA sequence, Immune repertoire of all immune cells, Gene expression of a mix of all immune cells on Affymetrix exon array, Gene expression on individual immune cell types. Especially NK cells, Gene expression on individual cells by molecular bar coding and sequencing, Evaluation of alternative splicing from exon array, Magnetic levitation profile of all immune cells DNA sequence all particles (virus, bacteria, fungus,& parasites), PCR assay for common viruses (EBV, HHV6, CMV, enterovirus), MS/antibody assay for mycotoxins, Cu concentration and other metals, Development of software for Hypothesis Generator using our data and all literature
Saliva: DNA sequence all particles (virus, bacteria, fungus, & parasites) PCR assay for common viruses (EBV, HHV6, CMV, enterovirus), MS/antibody assay for mycotoxins
Sweat: In real time, remotely by wearable electronics Na, K, glucose, lactate and cytokines
Urine: DNA sequence all particles (virus, bacteria, fungus, & parasites) PCR assay for common viruses (EBV, HHV6, CMV, Enterovirus) MS/antibody assay for mycotoxins Cu concentration and other metals
Feces: DNA sequence all particles (virus, bacteria, fungus, & parasites) PCR assay for common viruses (EBV, HHV6, CMV, enterovirus) MS/antibody assay for mycotoxins
Cort,
I’m so glad this is funded, and we have more great scientists working for us now. I’d love to know what tests Ron has run on his son Whitney, and what the results were!
I believe they were amino acid tests. I’m not sure which ones came back off the charts…They made sense, though, with what we know about this disease..
Hmmm… Do u know if anyone else has studied amino acids?
I agree that a study like this is exactly what is needed. I think there’s even a quote from Byron Hyde from quite a few years ago that said the same thing. Take hundreds of patients and just measure the hell out of everything and see if any common groupings occur to try and find subtypes. When/if you find one or more subtypes then things can really begin. For instance the Norway Rituximab studies look like they found three distinct subtypes- non-responders, erratic responders and global responders. To ferret out even one of these subtypes and have it be objectively identifiable would be groundbreaking. All these studies that only measure one or two things and then don’t follow the same patients to see what findings correlate with what are basically just wasting money since ME/CFS doesn’t appear to be one homogenous disease, at least until universal patient identifiers start becoming implemented. That’s where all this ‘invisible illness’ bullshit comes from, it’s not ‘invisible’, it’s just under-researched and compounded by distinct subtypes. I think what would be even better would be to do a study like this before and after exercise challenge.
I am curious what kind of software development they are looking to have done…
What great news….both on a personal level for Dr Davis and the whole ME,especially severely affected community.As a UK severe sufferer(24years) I heard of an eight man practice,only 7 of whom .”believed”in ME……simply unacceptable in 2015.Of course if the illness isn’t taught in medical schools,it’s sadly no surprise…..but all the while any medical directives emanate from the psychiatric school so prevalent here.Anyway,sending every good wish to the team….thank you for focussing on the severely affected,and hoping for encouraging results.God bless them all.
What great news….both on a personal level for Dr Davis and the whole ME,especially severely affected community.As a UK severe sufferer(24years) I heard of an eight man practice,only 7 of whom believed in ME……simply unacceptable in 2015.Of course if the illness isn’t taught in medical schools,it’s sadly no surprise…..but all the while any medical directives emanate from the psychiatric school so prevalent here.Anyway,sending every good wish to the team….thank you for focussing on the severely affected,and hoping for encouraging results.
Good for John Kim in tackling the stigma issue.
I think a better link would be this one, which takes people to his first post in that thread:
http://www.cortjohnson.org/forums/threads/id-like-to-learn-about-the-stigmas-you-guys-face.2944/
Whoops – thanks Sasha. I will fix it.
We have a moral duty to help those with severe ME the most. Their quality of life is terrible and the pain and suffering is unimaginable for them and their families. I am very relieved and excited to see this project getting off the ground and I think it will reveal a lot of very interesting things in the process of this awful disease. I also believe we need to find our voices and tell the REAL story of ME suffering to the world not the Intitutionalised nonsense reiterated by those that have either other agendas or no clue.
This, to me, is THE most exciting research initiative of all!
I came across Whitney’s story online a few months ago…and from there linked to the Davis’s project. I’ve forgotten the amount of fundraising that had been reached at that time (seemed to indicate far from the goal) but look now!!! I will follow this research with High Expectations… Just wondering what is the most effective way to help spread the word? Thank you Cort for posting this good news 🙂
This is great news, but I can’t stop thinking of Whitney and his family and what they are going through. Have you heard any news? Has there been any improvement in Whitney’s condition?
No – no improvement unfortunately….
The key message: that pilot/hypothesis generating studies are the bottleneck (as it is so hard to get funding for them), but also the key to further studies that may be the breakthrough we are after.
Pilot studies are inherently a gamble, hence why it is so hard to get funding. But there is also a new form of funding available: crowd funding.
The second key point is that the NIH should stop fumbling the ball and form a new multidisciplinary institute who’s purpose is to BUILD RESEARCH CAPACITY in newly discovered diseases along with neglected diseases, until they finally have a hope in other institutes.
Basically nothing is going to change until there is successful leadership within the scientific community, to the point that far more research is being funded. It doesn’t matter where it comes from, private or public but it needs to come from somewhere. Ron Davis is one of those leaders, but it is going to take more than just him to start a movement.
This is amazing news. Can you please advise how one participates in this study?
Thank you!
May go to their site – http://www.openmedicinefoundation.org/ – and try their contact button…I can’t think of any other way actually.
Thanks for your reply, Cort! Yes, I should have mentioned that I did go to the site and couldn’t find any info at all on participation, which I thought was a little odd.
Thank you, Cort, for all you do. I am a severely ill bed bound ME patient (20 years). Your work has saved me from severe depression. For 20 years I have been too ill to do the research necessary to possibly get better. Not having the ability to “try” to save my life caused severe
depression. Thank you for lifting the burden of finding doctors or possible treatments right off of the shoulders of severely ill patients.
I am so grateful.
When I am able I will call Ron Davis at Stanford. Is it too late to participate in his study? Thank you.
I do not know how to donate on line. Do you have an address for donations ?
Hi China – thanks for your nice words. I’m sorry you’ve been so sick for so long. I don’t know if the study is filled up but if you’re in the Bay area please give them a ring or an email.
I certainly do have an address for donations for Health Rising 🙂 the address is Cort Johnson, 2555 Hampton Rd. Unit 6308, Henderson, NV 89052
Stay strong! Ron is working as hard as he can to solve this. You never know….
Hello All,
This is fantastic news for us all. My physician had me take the 23andMe genetic panel to see if there was any genetic reason my body was not responding well to IV therapy (which had been semi helpful in the past). I am wondering whether my genetic results could be helpful to any CFS studies and, whether other CFS-folk who have done 23andMe (or other like-tests) would want to make their genetic information available to those studies as well? I noticed that 23andMe has partnered with the Michael J Fox foundation and is compiling information for Parkinson’s research from people who are willing to share their genetic results. Perhaps a like-partnership for CFS research could be helpful?
I think that’s a great idea Melody and it seems quite a few folks have done the 23and Me.
I’m thrilled that this study has been funded – for Whitney, his family, all the others who are so severely ill, and the rest of us.