Proposal to Vastly Increase Funding for ME/CFS at NIH Passes First Test

Discussion in 'ME/CFS and FM News' started by Cort, May 26, 2016.


Which ME/CFS Centers Would You Want to Be Part of the NIH's Consortium (pick five)

  1. Bateman - Horne Center (Bateman/Vernon)

    14 vote(s)
  2. Center for Infection and Immunity (Lipkin/Hornig)

    24 vote(s)
  3. Chronic Fatigue Research Center at Stanford (Montoya)

    10 vote(s)
  4. Institute for Neuro-Immune Medicine (Klimas/Fletcher/Broderick)

    18 vote(s)
  5. Nevada Center for Biomedical Research (NVCBR) (formerly WPI: Lombardi/De Meirleir)

    1 vote(s)
  6. Neuroinflammation, Pain and Fatigue Laboratory (Jarred Younger)

    22 vote(s)
  7. Open Medicine Foundation/Open Medicine Institute (Ron Davis and a cast of luminaries)

    29 vote(s)
  8. Simmaron Research Foundation (Dr. Peterson / Isabel Barao)

    16 vote(s)
  9. The Solve ME/CFS Initiative (Carol Head/Zaher Nahle)

    14 vote(s)
Multiple votes are allowed.
  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    It turns out that you can't just ask for a pot full of new money for a disease at the NIH. You have to get permission to ask first. Basically you have to get clearance or agreement from a council of your peers that that the concept or idea you have; in this case, increasing research funding for ME/CFS dramatically - is worth going after.

    "Concepts" at the NIH represent early planning stages for initiatives to increase research in "understudied and significant area(s) of science." Concept clearance - which was what Vicky Whittemore was going after today - is needed before an Institute will accept proposals for significant new funding.

    Clearance for a concept does not guarantee that requests for applications (RFA's), or request for proposals (RFP) or other grants will be approved. The leader of the meeting said, however, that it was "not uncommon" that cleared concepts turn into RFA's and grants.

    Vicky Whittemore

    Vicky Whittemore quickly made her case. Myalgic encephalomyelitis/chronic fatigue syndrome is a very serious disease that typically begins with an infection. She said she had met patients who had been sick for over 30 years. She asserted a desperate need to bolster research and increase researcher capacity existed.

    She wasn't talking about simply increasing research; her goal is to develop a research infrastructure that works - that puts ME/CFS on a par with other established diseases. In essence she was talking about a new way of studying ME/CFS.

    In fact, the ideas she laid out have been germinating in the ME/CFS research for some time. Probably a decade ago Suzanne Vernon challenged the ME/CFS research community to develop gold standards for research that would allow researchers to generalize their results across studies; in other words - produce studies that make a difference. Some work was done to that end but that idea's time had not yet come.

    Ron Davis's ambitious Open Medicine Foundation proposal to create a consortium of researchers to tackle ME/CFS in a methodical and organized way surely helped birth the second part of Whittemore's proposal. She sought to develop a consortium of research centers which used similar protocols, data elements and which developed large patient cohorts for study.

    These research centers would approach chronic fatigue syndrome using a variety of approaches. Each would be tied to the other via a central data network. Encased within the consortium concept would be the ability to add more sites in the future.

    Whittemore said she and others were astonished to learn there were no training grants to develop new researchers in ME/CFS. She noted that currently there was little communication between doctors and researchers that could enable translational efforts in the field. She stated a program called NCATS developed at the NIH that fosters those kinds of partnerships would help guide the Working Groups efforts.

    Embedded but not strictly mentioned in Whittemore's proposal were RFA's, Centers of Excellence and clinical trials. All would be needed to build the infrastructure the Working Group asserts is necessary.

    Unanimous Vote

    Her presentation done Vicki Whittemore asked for questions. I held my breath. How did the Council of her peers respond? With just two questions; one regarding diagnostic problems and the other recommending an NCAT program.

    Whittemore stated that the Working Group is working with the FDA and the CDC to develop common data elements to be used to subtype patients. She believes ME/CFS probably consists of a large spectrum of diseases. Following the NCAT model, patients would be involved in the Consortiium's work.

    With that it was on to the Council vote. I held my breath again but again it was anticlimactic. Most people raised their hands "yes", some didn't vote but no one abstained or said no; the vote was unanimous, and the concept to build a new research infrastructure for myalgic encephalomyelitis/chronic fatigue syndrome was approved.

    I wouldn't call the group enthusiastic - nobody applauded the idea - but they weren't antagonistic either, and most importantly, they passed the concept through.

    This "concept" needed to pass only one Council meeting - this one. Vicky Whittemore said the next step was to "finalize the details for the funding opportunity announcements and get agreement from all of the Institutes."

    The Consortium Centers

    While nothing is certain lets speculate on possible consortium centers. My guess is that the Centers with the greatest possibility of becoming consortia are those that a) already have developed research/treatment programs, that have shown their ability to successfully deliver on funding and are known to the NIH. I've probably forgotten somebody (lol) but these came to mind.

    The Bateman-Horne Center
    - the Bateman Horne Center is just being built but what better way to enhance ME/CFS research than giving Lucinda Bateman - an experienced and respected doctor - and Suzanne Vernon - a creative disrupter in this field if there ever was one - a chance to grow their Center rapidly. Suzanne Vernon is bursting with ideas, and has brought more new research talent into this field than anyone. Dr. Bateman has probably been involved in every major ME/CFS and FM clinical trial over the past ten years, is acknowledged to be a superb diagnostician, and has participated in every way imaginable. Plus this field just does better when people like Suzanne Vernon have funds to play with.

    Center for Infection and Immunity - Mady Hornig recently stated she hopes the CII becomes a Center of Excellence for ME/CFS. It's hard to imagine that not happening given the immense amount of research occurring at the CII, the large biobank it has access to, and it's top research and medical talent.

    The CDC's CFS Research Program - this program may have the largest budget of any ME/CFS program and it's hooked into treatment with its massive ME/CFS multisite program. It's inclusion in the Consortium seems a given. (Therefore it is not included in the poll).

    Chronic Fatigue Syndrome Research Center at Stanford - At first blush, Dr. Montoya's Chronic Fatigue Syndrome Research Center seems like a natural. Montoya is a great spokesman for ME/CFS, and he's ensconced in one of the top medical Universities in the country. Plus Dr. Montoya has been able to enlist several outside researchers in his effort to understand ME/CFS.

    The Chronic Fatigue Syndrome Research Center's record of publication, however, has been meager. Dr. Montoya's five million dollar donation in 2008 (and he's surely had others) has resulted thus far, in just two publications; one by a researcher (Jarred Younger) who's left Stanford. Montoya has also lost the services of the Zinns. Besides, with the Ron Davis/Open Medicine Foundation effort flourishing there's room for only one research/treatment consortium at Stanford.

    Nancy Klimas's Institute for Neuroimmune Medicine
    - Ditto with Dr. Klimas's effort. The Institute for Neuroimmune Medicine, with its treatment and research facilities, is already a COE. Dr. Klimas and Dr. Fletcher are able to consistently get grants and produce papers. Plus Dr. Klimas has done everything and is respected everywhere. It's hard to imagine that Dr. Klimas' venue wouldn't be near the top of the list.

    Jarred Younger's Neuroinflammation, Pain and Fatigue Laboratory - Jarred Younger is a dynamic young researcher who's shown he's able to get grants and communicate effectively with the patient population. His lab has grown rapidly, he's developing new technology, and he appears to have full backing of a major University (University of Alabama at Birmingham). He does not have a treatment center as yet but hopes to get one and to initiate speedy treatment trials in the future. If the Working Group's Initiative takes off, sooner or later Jarred Younger is going to be involved.

    Open Medicine Foundation/Ron Davis group - Ron Davis is new to ME/CFS research but the talent he has gathered around him, the money the OMF has been able to raise to fund his work, and the Open Medicine Institute's nearby presence with its ME/CFS knowledgeable practitioners makes this group an obvious center. Ron Davis is the big draw but let's not forget Dr. Kogelnik's vision for the OMI and the chronic fatigue syndrome field. He birthed the multi-site project that is consuming much of the CDC's CFS groups time and resources, is bursting with ideas about how to use bioinformatics and the social media to inform research, and founded the Open Medicine Foundation.

    The Solve ME/CFS Initiative (SMCI) - The SMCI has decades of experience funding research, the most productive Biobank in the business, a new patient registry, a dynamic new research director and will soon begin funding a new round of pilot grants. It's funded more significant pilot studies than any other organization, and is connected every which way with researchers, doctors and the feds. It doesn't have a physical infrastructure but it's got to fit in here somewhere.

    Simmaron Research Foundation
    - the Simmaron Research Foundation with Dr. Peterson has shown time and time again that it can deliver in its collaborations with others. It's engaged in numerous research projects, including quite a few it has initiated. and it's shown the ability to get NIH grants. The question with the SRF is infrastructure. Dr. Peterson has a medium sized clinic with little lab space. Would Dr. Peterson want or be able to expand?

    The SRF's questions immediately bring to mind a nearby entity that has an excellent lab and the space to fulfill the needs of COE. That, of course, is the....

    Whittemore Peterson Institute - Now the Nevada Center for Biomedical Research (NVCBR) - Dr. Peterson stepped away from the WPI before it got fully started and his departure was timely given the chaos that soon enveloped the WPI. This is a different, soberer NVCBR now, though.

    It's simply a beautiful facility and has a wonderful lab and it's fully embedded at the University of Nevada at Reno. Annette Whittemore has built a facility that could and should be a focal point for ME/CFS treatment and research. Structurally it's a perfect site for a COE, but it might need a Dr. Peterson and his many connections to get the nod. Could Annette Whittemore and Dr. Peterson join forces again?

    Hopefully the NVCBR's best years are ahead of it.
    Last edited: May 28, 2016
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  2. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    The SMCI got late into the poll because they don't have a physical infrastructure that supports a Center of Excellence - at least so far as I understand COE's - but they've done so much work and have the best biobank in the business so I added them in late. I would be really surprised if a consortium did not involve the SMCI...

    Since they got in late their vote totals are not accurate.

    (I knew I would leave somebody out.)
    Last edited: May 27, 2016
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  3. Marcie Zinn

    Marcie Zinn New Member

    What about Lenny Jason's work, and his team?
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  4. Rachel Riggs

    Rachel Riggs Well-Known Member

    @Cort Why haven't Montoya & Davis combined forces? Neither of them strike me as big ego guys...
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  5. Simon

    Simon Member

    Great write-up, Cort. I saw the presentation but desperately needed someone to explain it to me - thanks for doing so.
    (Full transcript here)
    And very interesting thoughts on the possible consortia/centres.

    Btw, here's NCAT: nb translational, which means an emphasis on going from lab to bedside:
    About the Center | National Center for Advancing Translational Sciences

    Last edited: May 27, 2016
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  6. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Good question. Montoya is right there - had his operation in place yet is not closely allied with Davis;. Instead, Davis is working with the Open Medicine Foundation and Andy Kogelnik. The Open Medicine Institute probably has more space and has two doctors working with them. From what I've heard recently people who see Montoya actually see his PA now. His clinic may not be as big...? Still I don't know why they're not closely allied.
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  7. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Thanks Simon...On to the next step :)
    Simon likes this.
  8. Charmian

    Charmian New Member

    If I remember correctly, one of the questions was about involving patients and advocates in plans for the research. Dr. Whittemore apologized for leaving that out of her presentation, and said yes, the planning would definitely involve patients and advocates. This is something advocates have been asking for.
  9. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Yes, indeed. Thanks. I put that in.
  10. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    With regards the SMCI and the Consortium Carol Head reported

    "We consider our lack of the physical infrastructure (and the high overhead costs that go with it) an advantage. We have put together agreements with three universities and/or private companies (e.g. Metabalon) to do the “wet lab” work for us….and at much lower costs. So as we ramp up our new research program under Dr. Nahle, we will be conducting our OWN research, as well as funding the research of others. We absolutely need/want to be part of the NIH consortium. You’ll hear more about our plans soon…"
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  11. Stephen

    Stephen Member

    What's the word on the Lipkin/Hornig gut microbiome study?
    Dr. Mady Hornig seems really nice. She graciously responded to a couple of e-mails I sent her.
    Columbia University has the potential to be an incredible center for me/cfs research!

    It doesn't sound like Montoya has put out a lot of research. Wasn't he supposed to publish results from a second enormous
    antiviral study? But maybe that's still in the works.

    Among the most aggressive researchers/advocates seem to be Ron Davis and his associates, Ian Lipkin and Mady Hornig, Jared Younger, and
    Suzanne Vernon.
  12. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Yes, Montoya in Spring of last year said to expect some exciting pathogen results; that's from a huge study - at least 800 people if I remember correctly; maybe its just taking time.

    I believe the analysis of the first set of gut microbiome results is done; I imagine that we'll see a publication fairly soon - although "fairly soon" in research circles can take quite a while.
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  13. Stephen

    Stephen Member

    Maybe it's time we follow up with Montoya's staff to see where they are in the process of things. An 800 person study with significant pathogen results
    would probably garner media attention on the national scale. Not to mention maybe a refocus on antivirals.

    On the viral forefront, from an article on the HHV6 Foundation website, Dr. Kazuhiro Kondo and two other virologoists at Jikei University School of Medicine have filed a patent on a method to diagnose, treat and prevent mood disorders which he says are initiated by a neurovirulent latent HHV-6B residing in glial cells. And the condition can be treated effectively using nasal sprays using the olfactory nerve as a route to the brain.

    The method is reliant on the measurement of SITH-1 antibodies which are produced via an expression of an HHV6 latency associated gene. Kondo and his associates showed evidence that these antibodies are found at higher concentrations in people with depression and chronic fatigue syndrome.

    The patent claims that when these antibodies are produced, it results in the upregulation of several depression related factors relating to stress hormones.

    Seems like a promising line or research and treatment. HHV6 can be quite a nasty virus. It's one of the few viruses that can be integrated into human dna (the complete HHV6 genome integrated into the telomere of every chromosome) in a condition called ci-HHV6 which is inherited from parent to child.
    While most individuals with ciHHV-6 are asymptomatic, individuals with ciHHV-6 may be overly represented in certain patient populations such as encephalitis and chronic fatigue syndrome.

    ciHHV-6 is distinguishable from an active HHV-6 infection by new testing developed by the University of Washington Dept of Laboratory Medicine

    Chromosomally integrated HHV-6 individuals will always have a very high viral load—generally over 1 million copies per ml on whole blood samples, and over 3,000 copies/ml in serum. This high viral load can sometimes be mistaken for an active HHV-6 infection, and therefore can result in the unnecessary administration of potentially toxic antivirals to patients not actually suffering from a viral infection.

    HOWEVER (and we go full circle back to Montoya, I pulled this quote from the article):, Some ciHHV-6 individuals may have difficulty defending themselves against community acquired strains of HHV-6, resulting in persistent infection, cognitive dysfunction and fatigue (Pantry 2013, Montoya 2012).

    It seems like a lot of the pieces of the puzzle are coming together - dysfunctional oxygen metabolism/ methylation issues/mitochondrial issues (resulting in cell signaling dysfunction) - difficulty keeping a lid on active herpes viruses residing in nervous tissue in the brain and periphery - lactate - glial cells - upregulation of stress hormones - HPA axis / microbiome -gut brain axis - and of course the connection between the nervous system and immune system.

    And HHV-6 may emerge as a big bad boy in all of this!
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  14. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Thanks Stephen.

    That's a fascinating article on Kondo's work. I think the percentage of cHHV-6 individuals is probably going to be low (?) but I agree they may be over-represented in ME/CFS. I like your model there :)
  15. Sunnyday

    Sunnyday New Member

  16. Stephen

    Stephen Member

    Cool! Didn't know they were in the game.

    Have they made any significant discoveries yet?
  17. Stephen

    Stephen Member

    You're probably right that cHHV-6 is low percentage. It will be interesting to find out more in that regard as few labs have begun testing for it and few people have undergone testing for it. I'll let you know my results for cHHV-6 when they come out in a few weeks (I'm guessing I don't have it). But blood work throughout my past has shown an almost constant low grade and sometimes extremely high grade HHV-6 presumably active infection on IgM blood tests.

    You're right that the most interesting take away is Kondo's patented nasal spray for HHV-6. This may be the delivery method for antiviral intervention or perhaps in addition to standard anti-viral treatment.

    My mind keeps on going back to dysfunctional oxygen metabolism, low ATP, low grade inflammation and lactate buildup in the brain. The brain seems to be the most vulnerable or sensitive organ to oxidative stress and inflammation. Perhaps, that is why we see a much larger incidence of "so called" psychiatric conditions like anxiety and depression over me/cfs (because of the brain's particulary high demand for ATP, it's sensitivity to inflammation and changes in pH).

    "Recent studies have shown that people with panic disorders constantly build up excess lactate in their brains during ordinary mental activities...Carbon dioxide also acts like an acid in the body and in the brain." It appears that some individuals are much more sensitive to pH changes in the brain than others. "Most patients with panic disorder will experience a panic attack when they inhale air containing 35% carbon dioxide, while most healthy volunteers will not...Interestingly, the close relatives of panic patients will also panic during carbon dioxide inhalation, even if they have never suffered from an anxiety disorder."

    Evidence suggest that people with panic disorder are not only hyperventilating when they are having a panic attack, they are hyperventilating all the time. At least according to the research that was performed at SMU.

    From that research a biofeedback device was created and marketed under the name Freespira

    This biofeedback device can be ordered through a licensed therapist and it measures one's output of carbon dioxide. The device is a small CO2 sensor that connects to a tablet via bluetooth. A breathing tube connects to the sensor. By altering your breathing pattern, you can optimize your CO2 levels. Apparently, as important as one's respiration rate is, optimal CO2 is even more important.

    Optimizing CO2 through proper breathing would lower acidity level in the brain. I have the device, and it is amazing how low from the "optimal threshold" my CO2 can be under times of stress.

    I am supposing there is crossover on this lactate/carbon dioxide in me/cfs although perhaps not resulting in the same symptoms as in panic disorder.

    CQ10 appears to be able to pass through the blood-brain barrier

    Perhaps in part, that ability to pass through the blood-brain barrier, is what allowed for the significant results in the (albeit small) study of Gulf War Syndrome patients with CQ10 supplementation.

    The press release for the study mentions that a "high quality brand" of CQ10 was used. The brand used appears to be manufactured by the Danish company PharmaNord. Their products are now available for purchase in the US.

    If CQ10 helps optimize energy production, lower output of reactive oxidative species, and speculatively decrease dysfunctional mitochondrial cell signalling activity (as Dr. Naviaux's research suggests is occurring in me/cfs), then perhaps it could indirectly serve as a neuro anti-inflammatory agent in the brain, in addition to increasing energy in the rest of the body.

    I guess there will be more to come on this topic.
    Last edited: May 28, 2016
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  18. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Yah Baraniuk good idea.

    Baraniuk is embedded in a University Hospital in Georgetown and I believe he may have a clinic as well. He's done a lot of research on ME/CFS and GWS and he can definitely get grans...and he's a strong advocate for ME/CFS.
  19. Merida

    Merida Well-Known Member

    I am positive for HHV6, Cytomegalovirus, Epstein-Barr. However, I am still in the structural camp, with viruses as a complication to a basically structural problem. Hence, we are more susceptible, and have trouble controlling and clearing viruses.

    I just hope some of these research groups will consider the possible structural aspects, and the possibility that a significant number of chronic fatigue people may have a small lower skull, scoliosis, altered CSF flow, crowded cerebellum/brain stem. These structural issues cause chronic inflammation and irritation of the central nervous system. The parallels between Chiari and Chronic Fatigue symptoms, patient profile groups ( ie - clear predominance of women, white European types) are virtually indistinguishable. Read at Conquer Chiari if you have any doubts. This site is run by Rick Labuda, another dedicated, very smart guy - like Cort