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. Linda Tannenbaum , Executive Director, Open Medicine Foundation
…He Has A Plan
Dr Andreas Kogelnik, the leader behind OMI-MERIT has an MD, a Ph.D in bioengineering and did post-graduate work in immunology, microbiology and bioinformatics. He worked with Dr. Montoya at Stanford on the ME/CFS antiviral trials but felt that projects could deliver results faster outside of academia so in 2009, he left to create the Open Medicine Institute (OMI). Back in 1998 he also managed to start a software company called Flexis.
Take a close look at his past; bioengineering, molecular biology and genomics, microbiology, bioinformatics and software and you have the foundations for OMI-MERIT. The Open Medicine Institute and OMI-MERIT is a digitally derived, opensourced, 21st century research effort that aims to collect, analyze and apply massive amounts of data to solve the unknowns around ME/CFS.
How does the Open Medicine Institute plan to do that? They innovate, they collaborate and they ‘crowdsource’ in every way they can. Networking, using efficiencies of scale and crowdsourcing is Kogelnik’s forte. He’s got ideas sprouting out of his head how to jam immunology, bioinformatics and social networking together to produce results. (We’ll se e much of this in an interview coming up). He’s thinking on a vast scale in ME/CFS and neuroimmune disease.
In some ways you have to operate that way to get at chronic fatigue syndrome. It’s a messy disorder that doesn’t lend itself to small solutions. The research is pretty scanty, the definition relies on symptoms and poor funding and small research studies have been the norm. Given that, it’s no surprise we’re still mucking around with the definition problem thirty years later. Thus far this research field has been like the blind men and the elephant; everyone has their view point and each is partially right but all are missing the big picture.
Building that big picture will take big studies that can encapsulate the disorder, organize it and then break it down into its constituent parts. It will take projects that can capture ME/CFS in all its glory and then dig down to uncover the subsets in it. That is what OMI-MERIT more than any other research effort that I can tell is about.
It took about 20 ME/CFS luminaries two days in New York City, last year to figure out how to do that. Many of the major figures (Bateman, Fluge, Mella, Hornig, Klimas, Lapp, Light, (didn’t make it), Montoya, Peterson, etc.) were there but there were also some new additions such as Ron Davis, an eminent geneticist/genomist working out of Stanford, Yenan Bryceson, an immunologist from Sweden and Simone Pensieroso, a virologist from Italy.
They came up with a $14 million dollar laundry list that they think could do wonders for ME/CFS.
OMI-MERITS first (and most expensive) project – a big rituximab/valganciclovir trial – is a good example of how OMI-MERIT and Kogelnik works. The first thing to notice is that it’s big – aiming for up to 500 patients – and in the molecular field bigger is definitely better.
Besides figuring out if rituximab and valganciclovir are effective treatments, the trial would also employ ‘exceptional measures’ of genomic, immunologic, virologic and physiologic markers. The OMI-MERIT take would essentially throw the molecular book and then some, so to speak, at the patients in the trial to try to learn what’s going on in patients that get better and what isn’t going on in those that didn’t get better.
Why go to the extra trouble? Because this is a two-fer trial; this isn’t just about getting better on Rituximab and Valganciclovir – it’s also about finding biomarkers that finally expose the subsets present in this disorder. Detailing the physiologic changes that occur as some patients improve will expose the deficits that allowed them to get ill in the first place. This makes patients that are getting better a great place to look for biomarkers.
Beside, while some patients may recover many will ‘just’ get better and getting them all the way better will require knowing exactly what’s gone wrong so that better drugs or drug combinations can be produced. This trial and the MERIT projects as a whole aren’t about just getting better, they’re about getting at the roots of ME/CFS.
This two or three or four-fer approach is how Kogelnik and the really good researchers in the field work. There’s always more than you think going on… as far as rituximab is concerned, this is the way to go.
International Neuro Registry and Biobank
The second priority on OMI-MERIT’s list – the International Neuro-registry and Biobank – also exemplifies OMI-MERIT’s conviction that breaking the code on this disorder requires big data. Not only would this registry be huge (10,000 patient samples) and comprehensive (blood, saliva, stool, spinal fluid, etc.) but it would track patients over time. This combination would allow researchers to get at the ‘biological clusters’ ; ie the subsets in the ME/CFS population. This is already off to a great start through the OMI Clinical Research Network and will open for general public input later this year.
Other projects would look at protein panels to identify viral, bacterial, antibody, hormonal, cytokine and other protein based substances in patients substances. Another project would take a cut at treatment, this time looking at drugs such as Famvir, Ampligen, Etanercept, Rifaxamin, Issentris and others, all the while pinpointing molecular changes to identify biomarkers. A particularly exciting immunologic project would examine B, T, NK cells responses using methods never before applied to patients in this disorder.
Worried about toxins? One project will use mass spectroscopy to identify toxins and unknown compounds to find unusual substances that could be mucking up ME/CFS patients systems. Have problems with pathogens? A pathogen project would identify a core group of testing methodologies for the pathogens in ME/CFS. With disagreement about how to test for many pathogens, any study that established standardized procedures would be a substantial advance.
Genetics? Another project will run several whole genomes as well as up to 1000 HLA gene sequences and DNA methylation. Hypervariable parts of our DNA focused on immune functioning the HLA sequence study could hold gold for ME/CFS patients. Amongst the most difficult parts of the genome to characterize, OMI-Merit’s focus this area speaks to the expertise they’ve been able to bear in the research.
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. – Linda Tannenbaum , Executive Director, Open Medicine Foundation
Is OMI-MERIT revoluitionary? In its scope and vision it is. We recently heard Bernard Munos, a biopharma insider call at the FDA Stakeholder’s meeting state that ‘big data’, collaboration and an open source approach to the this disorder will bring industry to the table.. By bringing ME/CFS experts together to set out an agenda and build an open-sourced platform OMI- Merit is doing just that. With the CFIDS Association bringing its commitment to open source and soon its tools to foster that we have two major players hopefully setting the stage for a new era of research.
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