Whittemore presents ME/CFS proposal to NIH, May 26, 2016

Chairman: For open session, this is a concept clearance, and just to remind you, normally we’re expected to spend our appropriated funds, sort of open to all things within our mission, and if we decided to a priori say we’re going to set aside a pot of money for some particular topic, then we need to get some kind of concept clearance for doing that.
And so that means that we’re going to describe to you the basic purpose, scope and objectives of what a potential solicitation might be. So this is just a concept: you won’t be getting details about exactly how things will be solicited but the concept of what the particular goals are.
And so once we have that clearance then it is not uncommon that cleared concepts end up turning into RFAs or RFPs or other specific solicitations. What we want from Council is some feeling that you think that this is a sufficiently important goal that it would be worth setting aside some money to solicit for applications to accomplish those purposes.
So with that, let me then introduce Vicky Whittemore, who is Program Director in our Channels, Synapses and Circuits Cluster, and she is also the leader of a Trans-NIH Working Group on ME/CFS. And it’s been an interesting activity for her.
So Vicky, I’ll turn it over to you.
Vicky Whittemore: Right, thank you. So what I’m going to do today is to present a concept to you for research on myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, and ME/CFS is a very debilitating disease, with many of the individuals becoming ill post-infection and then becoming chronically ill over very long periods of time. I’ve met patients or individuals with ME/CFS who have been sick for more than 30 years.
There is no known etiology, there are no FDA-approved treatments, and it’s really a research area that is in desperate need of bolstering the research infrastructure and training.
So we are presenting this concept with several goals: to support research and to develop research capacity; to stimulate research, especially on the etiology of the disease and biomarkers of disease, as well as to develop a large, well-defined cohort that could then be utilized in future clinical trials, as well as to train young investigators.
And one of the things that was very startling to us when we did a portfolio analysis was to realize that not only is NIH – and this means any institute at NIH – not funding any training grants, so no Fs, no Ks, no Ts, we’ve never even received an application in those categories, which is pretty shocking.
So there’s significant need for building research infrastructure, for bringing in the ability to train, and to do research that involves multiple sites. And so our concept is that we would put in place a consortium with multiple sites utilizing common protocols across the clinical projects who can also then develop studies across the sites that would address etiology, potentially imaging, potentially biomarkers studies, genetics, that would all work together.
Because one of the other issues that we’ve seen in this research area is that the research that’s been funded and done by investigators typically involves fairly small cohorts of individuals with the disease and that there’s no generalization across and no way to get… group these patients.
So we would fund a consortium initially with several sites, together with a data-managing coordinating center that could help with… to standardize protocols, manage the whole consortium, with the ability then to either add additional consortia and/or additional sites to the consortia in future years, that would help to build this infrastructure that we could then also, down the line, implement clinical trials across the consortia utilizing these academic centers.
One of the things that’s also very interesting about this area is that the majority of clinicians and healthcare providers are not located at academic institutions. They are located in private practices, and so there really has not been that partnership between the clinicians and research investigators.
So one of the things that we worked very closely with our friends and colleagues at the National Center for Accelerating Translational Science, NCATS, is to think about how each of these sites could also then partner with the CTSAs [Clinical and Translational Science Awards] that could provide infrastructure and support and the ability to train as well as some of the other initiatives that their institute… that can help to support patient recruitment and clinical-trial readiness across this consortium.
So I have to acknowledge the individuals from the 24 different institutes and centers who make up the Trans-NIH ME/CFS Working Group, and especially Joe Breen who’s here from NIAID, Cheryl Kitt who’s here today from OER and again my colleagues in NCATS Todd Wilson and David Eckstein who’ve been especially helpful in helping us think this through.
If this concept is approved today, what we would do is move forward, working with all of the institutes to look at specific areas of interest that fall within the mission of each of the participating institutes, and joint funding of this consortium and the data management center. So I’ll stop there and see if anyone has any questions or comments.
Dr. Janet Hieshetter: What you describe sounds very similar to the NCATS Rare Diseases Clinical Research Network…
Whittemore: Absolutely.
Hieshetter: …which involves patient advocacy groups…
Whittemore: Yes:
Hieshetter: …and I think they had a really important role as it relates to patient recruitment and education and also just general support, so I would encourage you to think about a role for PAGs [Patient Advisory Groups] in the model that you’re putting together now.
Whittemore: Yes, I failed to mention that we already have considered that, that patient engagement would be a large part of the consortium as well. Thank you for that comment.
Other questions or comments?
Dr. Amy Brooks-Kayal: I just wondered, Vicky, is a part of this… are there very well defined criteria at this point for this condition? I mean, I think that’s been one of the areas that’s really held back research in this area, is that I think there are a lot of varied and often incorrect assumptions about what this disorder is.
Whittemore: That’s a very good question, and no, there are not. So as you may know, there are many different diagnostic criteria that exist out there that are more or less broad and capture more or less broad groups of patients.
One of the projects that we’re launching this summer, actually, is a project together with the CDC and FDA to look at common data elements that would be able to measure common elements across these patients regardless of the criteria that’s being applied so that we can begin to subtype and really look at some of these individuals, and groups of individuals, that fall into this what I think is probably a large spectrum of diseases but have been lumped into this category of ME/CFS.
#MEAction would like to thank the patient-volunteers who transcribed this material.


4 thoughts on “Whittemore presents ME/CFS proposal to NIH, May 26, 2016”

  1. Suzanne Williams

    I believe there are a good number of patients with Environmental Illness from toxic mold or chemical exposure that are under the ME/CFS umbrella. Their immune systems may be responding/expressing like the viral onsets in some ways but I think they are part of the types within the disease and perhaps should not be within the ME/CFS umbrella but we won’t know how to group any patient with accuracy until research can clarify what their immune systems are doing as opposed to the viral onset groups. (Which is basically what Vicky Whittemore was stating but I thought I would throw in the Environmental Illness information.) Not to mention tests that need to be developed to find if someone has had a toxic mold or chemical exposure. (Hopefully the blood test to read every virus a person was ever exposed to is going to be a reality sooner than later.)
    Co-infections in some are often thought to be the reason for ME/CFS onset but I believe are due to the immune and neuro-immune system breaking down and not being able to fight off current infections. I think Ampligen helps with these patients but in many ME/CFS patients I think it is a matter of “damage done” and the damage has to be reversed and the immune system snapped back into proper working order instead of trying to fight viruses that are not active or there at all.
    I also hate the verbiage of “sub” types and “sub” groups because it makes patients seem a lesser category. Perhaps stating “type” like there is 4 types of MS or 10 different breast cancer diseases but we would never refer to them as “sub” as if they do not have a difficult health battle to navigate. We are actually happy when they have the more treatable/survivable forms of these life altering diseases.

  2. This isn’t a “proposal” – it’s a kick-the-can-down-the-road exercise. It’s not even called a “proposal”; it’s called a “concept”. [1] The concept of having a research program now has to be approved by ALL TWENTY-FOUR agencies of the Trans-NIH working group. Anyone care to take a guess how long that might take?
    Actual proposals have details like a budget, required resources, a timeline, measurable goals, milestones, and steps required to reach the milestones. None of those elements are present in this “concept”.
    Ron Davis and his group will have answers before NIH can even write a real proposal. NIH is truly dead from the neck up. I suggest a mock funeral is in order.
    [1] Dr Whittemore stated, “So what I’m going to do today is to present a concept”

  3. As I read this I think, crap, maybe I should have created a change.org petition that asked the gov’t to allocate money to the already established institutions (like this one and Ron Davis’ and Nancy Klimas) who know what they’re doing and already have vital studies in place, just need the funding to complete them and do so in a timely manner. I think this is where reaching out to our local congressmen is going to make a difference. If we can get politicians behind this who understand the urgency, they can help direct where and to whom and how fast the funds are allocated, instead of further waiting on this agency to approve a crap-ton of paper work. I think if we get the right people (with decision making power) behind us, we may be able to go around the typical bureacracy and get things moving faster and more efficiently, with the needed funds. It just seems like we need to press the gas hard on all of this. I know this all takes time, but there must be a faster way. I’ll let you know what my senator says–talking with him soon.

  4. OIMOHO&E, via my 24+ years Advocating (I’m a PWC since early 1991, but proper Dx came late – “PTSD” was the convenient first label to limit my former Co’s LTD liability)… to me, this is just same ole, same ole! The 5 Governments [The 5 “Coalition Countries” especially – England being the most vicious, but Canada has bravely broken ranks with their MEDICAL – “Canadian Definition” – which Dr. Susan Levine sadly couldn’t manage to have the US adopt… & who we Advocates should ALL thank for her tireless and brave devotion to her PWC, and ALL of us, as she steps down from Chairing the CFSAC] have been slickly successful in dividing & conquering. Plus, they’re continuing to Study us to DEATH – literally! It really doesn’t matter WHAT you CALL ME/CFS – FM – Fibromyalgia – GWS, Asperger’s, Autism – POTS – NMH – PEM, et al….. so let’s call IT – “IT” for this purpose! “IT” is PROGRESSIVE, “IT” is COMMUNICABLE, and “IT” can be FATAL! This deliberate obfuscating with sub-types, et al, is just another attempt to NOT DEAL EFFECTIVELY with “IT”… someone on this site astutely said “… this is another attempt to Kick The Can Down The Road…” which is sadly, an all too apt observation. For instance, I just gave 3 Comments on Thursday to the CFSAC via Teleconference – and one of my laments to them is that in October 2000, when I gave two of my three prior Testimonies to the then CFSCC in person in DC, that now = 17 years later, my coining then of the Term “Economic War” being waged on us Patients, is tragically even more apropos. Big Pharma is making multi-billions on ‘Treating’ Symptoms (reference the long, long Symptoms List via Dr. Bell, Berne, et al, via “Running On Empty”), and drugging our children. The Insurance Cos are still hiding behind deliberate, and clever engineering of this being “AIYH” for 2 year limits on LTD Benefits. What I didn’t have a chance to broach, is that I buttonholed The VA Representative back then, and asked why they’re ignoring Dr. William Baumzweiger & intimidating him – when HE WROTE WHAT “IT” IS = “Brainstem Encephalopathy” & stated “IT” IS COMMUNICABLE, and he laid out Seven main “Cumulatively Disaffective Trigger Sets” that exposure to gets one to drop thru the ‘trap door’ into the basement I inhabit! They for a time, removed the VA from the CFSCC, and started meeting virtually, but not befoe The Military of each Service, showed up in Uniform, at the first & only SOS Conference in Key Bridge VA that October 2000 (if someone can obtain who they were via FOIA, I’d be grateful – please send to: [email protected]). There were disgraceful shenanigans thereat too via at least a couple of the LTD Cos’ Stooges finding their way thereat! Yet, The VA is still deliberately mis-stating Prevalence (they boldfaced did so in their report to the CFSAC on Friday, 6-30-17), and refuse to admit that AUTISM is TWICE PREVALENT in Military Families than in the GP! What “TYPE” will they buttonhole these children into to manufacture a reason to ignore THE FACTS / THE TRUTH? The TRUTH is that our NATIONAL SECURITY is being impugned by the hiding of these facts, instead of SOLVING “IT”, once & for all! HISTORY eventually will prove out – but after how many tragic fatalities and productive lives lost to the medically caused dysfunctions of “IT”, and the SYSTEMATIC INVALIDATION – which is the worst abuse, sans physical – plus the cost is astronomical (the determined, talented Dr. Lenny Jason’s study on the Economic Impact – that I begged him to undertake when I met him in DC one ‘Lobby Day’ – should be sufficiently persuasive, but sadly there’s other ‘pockets’ that are being lined that are more powerful)! But, surely NOT proven is: “Hystories…” (remember Elaine Showalter, the disgrace of an English Prof from Princeton – the ole’ boy network – who they built up to write that nasty piece of work to say CFS is a psychological construct of “Middle-Class, Whiny White Women” & promised her a whirlwind book tour to feed her giant ego) – well, I’ve NEVER been HYSTERICAL, and in my quarter of a Century of ADVOCACY & Support Group Leadership – never met a HYSTERICAL PWC/PFM/GWS, et al – my brave son who was in Special Forces for 6 years – in Combat they tried to deny – is certainly NOT HYSTERICAL either, yet the VA made mincemeat of him & was further diabolically disgraceful when I had to intervene! Still, I’ve been extremely ILL with “IT” for over 25 years – with many MEDICAL PROOFS (which the Fed’l Courts slickly ignored to allow avoid my former Co – founded by Senator Lautenberg – from paying my rightful LTD Benefits… there’s more)! It’s criminally insidious, but thanks to many Advocates, including Hilary Johnson (she also participated in the CFSAC Web Meeting last week) – who documented a lot of the early shenanigans in “Osler’s Web”, and Co-CURE, Ray Colliton (RIP) who founded Co-CURE, indomitable Tom Hennesey (RIP) – who actually got Dr. Reeves [the slimy coward – who only came forward with the CDC’s method of ‘magic missing millions’ = $12.9M that ‘disappeared’ out of the CFS Budget (& his boss Dr. Koplan lied to Congress about it, while asserting that “… no one took a cruise on the still missing $4M…” – I’d like to know HOW he knows that? This still ‘missing’ $4M via the CDC could fund most of the “Microbe Discovery Project” at Columbia!!!!!) – shenanigans to save his own skin – so to punish us, they left him in charge] to ADMIT “IT” IS ALSO GWS, back in the 1990s! Plus I’m encouraged – only via the MIRACLE of surviving CFS – via of over ~50 Treatments of RITUXIMAB (which saved my life & I’ve had a Temp ‘remission’ of some symptoms) to witness the ‘new generation’ of Advocates in Ryan Prior (I believe he’s on the Board of Directors hereat) – whose Documentary “The Forgotten Plague” is a masterpiece. I was fortunate to have attended the Premier thereof in Atlanta (I highly recommend the CD thereof for a validation Tool for doubting Doctors & Family Members). Additionally, Ben HsuBorger who did a great job also speaking up in this CFSAC Web Meeting. And, Leah Williams of Mass CFIDS Assn participated impactively too (I supported Mass CFIDS with our donation via my stint on the Board of NJCFSA when they almost went defunct!). Plus countless other Advocates who are bravely speaking up & out! Well, it’s “IT” for sure! So, WHEN ARE THEY GOING to actually DO something positively impactive about “IT”? Tragically, they still choose to fiddle while Rome is burning!

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