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.
Collaboration and networking are key parts of OMI-MERITS plan
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.
Rituximab Trial
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.
A combined Rituximab/antiviral trial is OMI-MERIT’s top priority project. It’s also easily their most expensive one.
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
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.
OMI-MERIT is committed to building an enormous neuro-immune repository for ME/CFS
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.
Revolutionary?
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.
Health Rising Exists Because of Your Support
Hi Cort
Exciting stuff, and another great article, thanks.
“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.”
That’s a really interesting and very neat approach. However, it’s likely that many such changes are down to secondary consequences of primary causal changes. Do they have a plan to identify the causal from the secondary? It’s still an inspired place to look, but Im curious how they will handle the issue of causation.
The whole Open data thing is brilliant too. Here in the UK there’s talk of making all govt-funded research data open access, but it’s a long way from actually happening.
Some of what they are doing eg pathogen hunting and protein-profiling overlaps with the work Mady Hornig is doing, and you said she was involved at the beginning with this. Do you know if her work will become part of OMI’s open data?
Thanks Simon…I have no idea but I certainly hope Hornigs work either makes into OMI or into whatever the CAA is doing to bring data together.
Here, by the way, is the list of ‘signees’ for the OMI-MERIT program
Lucinda Bateman, MD (Fatigue Consultation Clinic & Univ of Utah, UT, US)
Alison Bested, MD (Complex Chronic Disease Clinic, Canada)
Yenan Bryceson, PhD (Karolinska Institute, Sweden)
Ron Davis, PhD (Stanford Genome Technology Center, CA, US)
David Dreyfus, MD, PhD (Yale/Private practice, US/Israel)
Oystein Fluge, MD (Haukeland University Hospital, Norway)
Mady Hornig, MD, PhD (Columbia Univ, NY, US)
Nancy Klimas, MD (NOVA Univ, FL, US)
Andy Kogelnik, MD, PhD – Chair (Open Medicine Institute, CA, US)
Charles Lapp, MD (Hunter Hopkins Center, NC, US)
Jay Levy, MD (UCSF, CA, US)
Alan Light, PhD (University of Utah, UT, US)
Kathleen Light, PhD (University of Utah, UT, USA)
Sonya Marshall-Gradisnik, PhD (Griffith University, Australia)
Mauro Malnati, MD, PhD (San Raffaele Scientific Institute, Italy)
Olav Mella, MD (Haukeland University Hospital, Norway)
Jose Montoya, MD (Stanford University, CA, US)
David Patrick, MD, PhD (Complex Chronic Disease Clinic, Canada)
Dan Peterson, MD (OMI and Sierra Internal Medicine, NV, US)
Simone Pensieroso, PhD (San Raffaele Scientific Institute, Italy)
Charles Shepherd, MD (Private practice, UK)
Ila Singh, MD, PhD (Mount Sinai School of Medicine, NY, US)
Carmen Scheibenbogen, MD (Charité Berlin, Germany)
Chris Snell, PhD (University of the Pacific, US)
Eleanor Stein, MD (Private practice, Canada)
Staci Stevens (Pacific Fatigue Lab, US) and
Rosamund Vallings, MD (Private practice, New Zealand).
Wow! That’s a lot. I am very happy such a great person for this job is actually doing this job!
Hi Cort,
Thank you for some much needed good news and information. I am always happy to see a Health Rising article in my in box! Keep up the great work.
Thank You
Thanks Michael 🙂
I don’t understand the Valcyte part of the Rituximab/Valcyte trial, which I think is the most expensive project in the list. Didn’t the second Montoya Valcyte study basically come up balls? From what I remember the second Valcyte paper that everyone was waiting (and waiting, and waiting…) for was basically a non-event. One thing that I’m still not sure of is how long the blinding went on in that study. I think I remember reading where someone (not sure if they were in the study or not) said that Montoya told them that they had to take it really easy for quite a long time (months and months) to basically ‘let their body heal’, ‘let the drug take effect’, etc. (paraphrasing what I remember, those aren’t direct quotes). The problem with this is that if the drug works then the patient should be able to do more, not less. Who wouldn’t feel a little subjectively better if they were told that they had to or were given permission to basically baby themselves for months on end?
I asked Dr. Lerner about the Montoya trial and he says does things differently but he still requires that his patients be very careful about exertion – that is apparently a critical need if the drug is going to work. Dr. Chia appears to say the same thing about Oxymatrine – my interpretation is that the drugs just aren’t effective enough to work without that.
Your point about the effects of really babying yourself (:)) is a good one; at some point they’ll need to work out what is the effect of the drug and what is the effect of the ‘babying:)
The Rituximab/Valcyte trial will – if I have it right -combine both drugs at least in some phases – so there will be an additive effect; the hope is the both will hit the B cells hard enough to more quickly get rid of the virus, I think.
“I asked Dr. Lerner about the Montoya trial and he says does things differently but he still requires that his patients be very careful about exertion – that is apparently a critical need if the drug is going to work. Dr. Chia appears to say the same thing about Oxymatrine – my interpretation is that the drugs just aren’t effective enough to work without that.”
That’s fairly worrying then because something like that could account for a huge percentage of a given intervention’s putative effect. I could be making this up, but I might also remember that person saying that they were even told to get their spouses/SO’s involved. Who wouldn’t feel better if they had someone waiting on them hand and foot ‘in order so that the drug (with the drug itself being supposed to result in improved functioning) can take effect’?
I’m less than impressed with the way that I’ve heard Lerner does things as well- the whole physician rated outcome thing kind of stinks to me. From what I remember, Lerner’s Valcyte paper reported a raise in score of 4 (not sure what the range was, ie if the scale was 1-10 or what). But if a physician rated a person as one point lower before treatment and one point higher at the end of treatment, that means that physician bias could have accounted for 50% of the total ‘treatment effect’ reported and could have actually doubled the legitimate effect of a given intervention. For instance if a person really was a 3 at the start of treatment but the physician rated them as a 2 and then the person ended up as a 5 but the physician rated them as a 6, this would double the ‘treatment effect’. Even if a person had no real improvement such a scoring system could easily give the impression that improvement had occured. When you have your whole career invested in a certain hypothesis this is way too much variability, for instance I remember reading posts by one PR forum member who said that Lerner became very irate with them when they told him they weren’t doing much, if at all, better on Valcyte.
We can’t tell the cause for sure without better studies but I do have a good number of recovery stories from Dr. Lerner’s patients that will be featured when I get the recovery/recovering stories series going. Something Dr. Lerner is doing is definitely working for at least some of his patients. He was the only ME/CFS physician to reply to requests for recovery stories.
I think it’s difficult for physicians to cross all their t’s and dot all their i’s in studies which, is, of course, why its so important to get more money into this illness so we can have the ironclad studies we want.
@John:
I think you might be thinking of:
—————–
Response to Valganciclovir in Chronic Fatigue Syndrome Patients With Human Herpesvirus 6
and Epstein–Barr Virus IgG Antibody Titers
Journal of Medical Virology 84:1967–1974 (2012)
Tessa Watt, Stephanie Oberfoell, Raymond Balise, Mitchell R. Lunn, Aroop K. Kar, Lindsey Merrihew, Munveer S. Bhangoo, and Jose´ G. Montoya
——
However, this was:
“An uncontrolled, unblinded retrospective chart review was performed on 61 CFS patients treated with 900 mg valganciclovir daily.”
It sounds to me like this wasn’t the trial we are waiting on.
Lucinda Bateman, MD (Fatigue Consultation Clinic & Univ of Utah, UT, US)
Alison Bested, MD (Complex Chronic Disease Clinic, Canada)
Yenan Bryceson, PhD (Karolinska Institute, Sweden)
Ron Davis, PhD (Stanford Genome Technology Center, CA, US)
David Dreyfus, MD, PhD (Yale/Private practice, US/Israel)
Oystein Fluge, MD (Haukeland University Hospital, Norway)
Mady Hornig, MD, PhD (Columbia Univ, NY, US)
Nancy Klimas, MD (NOVA Univ, FL, US)
Andy Kogelnik, MD, PhD – Chair (Open Medicine Institute, CA, US)
Charles Lapp, MD (Hunter Hopkins Center, NC, US)
Jay Levy, MD (UCSF, CA, US)
Alan Light, PhD (University of Utah, UT, US)
Kathleen Light, PhD (University of Utah, UT, USA)
Sonya Marshall-Gradisnik, PhD (Griffith University, Australia)
Mauro Malnati, MD, PhD (San Raffaele Scientific Institute, Italy)
Olav Mella, MD (Haukeland University Hospital, Norway)
Jose Montoya, MD (Stanford University, CA, US)
David Patrick, MD, PhD (Complex Chronic Disease Clinic, Canada)
Dan Peterson, MD (OMI and Sierra Internal Medicine, NV, US)
Simone Pensieroso, PhD (San Raffaele Scientific Institute, Italy)
Charles Shepherd, MD (Private practice, UK)
Ila Singh, MD, PhD (Mount Sinai School of Medicine, NY, US)
Carmen Scheibenbogen, MD (Charité Berlin, Germany)
Chris Snell, PhD (University of the Pacific, US)
Eleanor Stein, MD (Private practice, Canada)
Staci Stevens (Pacific Fatigue Lab, US) and
Rosamund Vallings, MD (Private practice, New Zealand).
That’s quite an impressive list.
And to think that not a SINGLE ONE OF THEM cares about
what happened here in this incident, and ALL refuse to find out.
http://www.youtube.com/watch?v=AW0x9_Q8qbo&feature=related
Yes it is Eric- some of these people have devoted their careers to this illness, at least five are ill themselves, or have sons, daughters or siblings themselves, many are brilliant and yet all are missing the point…It’s amazing! :)…In all seriousness I think they all recognize there are probably many ways to come down with ME/CFS and they are surrounded by people who’ve gotten sick from all different parts of the country and they have their own cohorts to deal with…and they’re dealing with them (???)
Wow – had no idea that OMI had all this planned. So the complete list of projects listed on the website adds up to the $14 million total? Or are these just a subset of projects that they can do now? Do we know how much of the $14M they have and how much they need? I hope that much of this can be funded by the government as opposed to patients.
Really great news, finally serious tools intended to find big answers.
Yes – very impressive. Yes, all those project add up to $14 milllion…Stay tuned…we’ll hear more from the OMI and OMI-MERIT and funding shortly 🙂
I wonder if somewhere in this whole project patients will be tested for lyme. In different ways. I know so many people who were formally diagnosed as ME/cfs but now have a Lyme diagnosis (besides ME/cfs).
And what about Bartonella? Not only B. Henselae, but also other Bartonella species.
Or the other (co)infections like C. Pneumonaie or Babesia?
Anyone knows?
I live in central FL and recently discovered a Doc up to the N.E. in Ormond Beach (about an hour drive est.)
His name is Dr. Dantini http://www.drdantini.com He has finished a drug study for the CFS/ME using antivirals.
I’m not really sure if I should pursue this type of treatment. How can I decide if it’s worth all the trouble? The driving, the gas money, the energy, the co-pays? Not to mention, are his intentions good? Is it worth the risk to my own immune system? Do you have any suggestions Cort or anyone else concerning my questions?
These are tough questions. I don’t really know Dr. Dantini but I did an interview with him and I think he’s sincere. I know someone who did very well with him…of course you can never tell how you’ll do until you try…It’s always kind of a crapshoot. Still, I think he’s got something going there. Good luck on whatever you decide to do 🙂
http://phoenixrising.me/archives/5199
Cort,
Thanks for the feedback. He has a lot of youtube videos and he does come across as sincere to me too.
I’m just not sure about all of the things I mentioned. I read your interview. I also read somewhere (maybe in the interview?) that he does not do HHV6 testing.
You said, that you ‘know of someone who did very well with him.’ Would you please ask that person to elaborate on that?
Thanks again,
Jeanna
Cort, I just noticed your archive link and am reading it again and now realize that the person you were referring to may be the lady who is the one mentioned in the article. I will read her story.
Thanks again and again,
Jeanna
I read these announcements with a mixed mind and mixed emotions.
On one hand I am glad to see Anybody doing Anything that Might in Any Way
uncover Anything that might help find a cure or even lessen the effects of CFS.
On the other hand – having had CFS for long,long time I have seen many
“break thru” s , “cures” etc…. Everything from the WPI virus debacle, the
alleged “energy testing” by Dr. Myhill, the 2’5’a RNASE-L “break thru”, the
porcine liver enzyme injections. etc. etc.etc.
My point – I would feel a lot more comfortable if the financial arrangements
of the Open Medicine Institute and its researchers vis-a-vi this $14 Laundry List
and the $1 million grant they have received were more much more open and transparent.
Time after time we have seen “research initiatives” and “research institutes” end up being
nothing more than “fund raisers” for those behind the “research”.
I have no reason at all to have any doubts about OMI – but with this kind of money sloshing about
and the somewhat sleazy past of CFS research – I think it would be really good thing if OMI pro-actively disclosed the financial arrangements with and compensation of those associatted with the CFS effort at OMI