Research Roadmap

Road MapThe Research Recruitment Working Group of the CFS Advisory Committee has been formulating recommendations that could potentially change the direction of ME/CFS research at NIH. Not much time has been spent on it at the last two meetings, but I think you need to pay attention to this. Dr. Dane Cook, chair of the Working Group, spoke with me about where they’re headed.

The Working Group was charged with two tasks: 1) increase awareness among researchers about ME/CFS research and 2) suggest strategies to increase the number of interested researchers who will apply for funding. Most advocates, myself included, have argued for the “build it and they will come” approach. If more money is made available for ME/CFS research, then more researchers will apply. Dr. Cook pointed out that CFSAC has been recommending increases in funding and RFAs for years without any success. In his opinion, it is time to try a different recommendation strategy.

Dr. Cook and the Working Group presented interim reports at the December 2013 and March 2014 CFSAC meetings. The Group has gathered data on the low number of CFS publications relative to the number of publications on both fatigue and fibromyalgia. They have also identified multiple barriers to increasing the number of interested researchers and retaining them in the field. I asked him to walk me through the three prongs of the Group’s current approach, with the caveat that this is not the final recommendation from the Working Group.

A Research Agenda Informed by the IOM and P2P Reports

The first step in the research road map is to articulate a clear research agenda based on the information and recommendations from the 2011 NIH State of the Knowledge meeting, as well as the forthcoming IOM and P2P reports. Combined, these three reports should identify gaps in the research and the priority areas for future inquiry. The IOM report may also resolve the dispute over the case definition, although it should be noted that IOM is creating a clinical case definition not a research definition.

Dr. Cook was pressed hard at the March 2014 meeting on the issue of urgency. The P2P report will be issued at the end of 2014, and the IOM report is not due until March 2015. The formulation of a clear research agenda wouldn’t begin until after that. Billie Moore and other CFSAC members expressed dismay at this timeline, and pushed for an immediate RFA. Meanwhile, a recent Congressional effort made a similar request of NIH, but this has come under fire from some advocates who believe that no money should be requested from NIH without guarantees of how it will be spent. They point to the recent denial of funding to Dr. Lipkin as proof that NIH cannot be trusted to make the right grant decisions.

Dr. Cook told me that the delay of waiting for the reports is the hardest issue for him personally. He would much rather see an increase in funding immediately. However, he pointed out that CFSAC has already pushed for this for many years. His assessment is that if CFSAC recommends another RFA now, the answer from HHS will be that they need to wait for the reports. Dr. Cook’s goal is to provide so much evidence of necessity that HHS will be compelled to act.

Championed by the Trans-NIH Working Group

The second prong of the road map is for the research agenda to be clearly communicated and championed by the Trans-NIH ME/CFS Working Group. Dr. Cook’s sense is that NIH is generally supportive of how he’s been working on this charge, but he did not articulate what “championing” would look like.

It’s important to remember that the Trans-NIH Working Group does not have a research budget, nor does it make the decisions on funding ME/CFS grants. But what it can do is bring people together from the NIH Institutes to promote ME/CFS research at NIH. Any step in that direction is a positive one, as long as the research is physiologically oriented and focused on the correct patient cohorts. Whether this could be achieved – and to what extent the Trans-NIH Working Group would evangelize it – is not entirely clear to me.

Strong Infrastructure

The final prong of the road map is to support ME/CFS research with a strong infrastructure. Dr. Cook is passionate about this, and believes that it could be undertaken immediately without waiting for the IOM and P2P reports. Currently, data sharing among ME/CFS researchers is piecemeal. Many researchers use REDCap to collect their data, and the system is designed to build and manage surveys and databases online. It’s an electronic data capturing system, not a system for aggregating and sharing data.

The National Database for Autism Research (NDAR) is a striking alternative model. NDAR was launched by NIH in 2006, and it offers both a data repository to facilitate data sharing and standardization, and a scientific community platform that offers access to other research repositories housed by other institutions. Applicants for NIH funding are strongly encouraged to contribute their data to NDAR, and data on almost 70,000 individuals with autism are available. Several NIH Institutes provide funding for NDAR, averaging about $2 million per year.

NDAR is far larger and more sophisticated than any ME/CFS data effort. Dr. Cook believes that ME/CFS research is in desperate need of such a resource. He also said that this could be pursued immediately, without waiting for the IOM and P2P reports. The big question is (as always) funding. An NDAR representative told me that the system could be rolled out for another disease area, such as ME/CFS, for about a quarter of the annual NDAR investment. But still, is NIH willing to invest $500,000 per year in building such a system for ME/CFS?

Where From Here

Dr. Cook indicated that the Working Group is continuing to refine its recommendation. His CFSAC term expires in early May, but he hopes to remain on the Working Group to continue and support the effort to finalize a recommendation to the Secretary.

I think many important questions remain: Is it appropriate to make the RFA contingent on the release of the P2P and IOM reports? Is such a delay acceptable? Who will be charged with articulating the research strategy? Will that person/group be willing and able to depart from the P2P and IOM recommendations if needed? Will the Trans-NIH Working Group champion this agenda and request an RFA? What does that look like? Who will be tasked with creating an NDAR-like infrastructure? Who will pay for it?

And the obvious question is: how long do ME/CFS stakeholders have to wait to see the investment of funding that this we so desperately need and deserve?


This entry was posted in Research and tagged , , , , , , , , . Bookmark the permalink.

16 Responses to Research Roadmap

  1. Kelly Latta says:

    I’m not sure the focus should continue to be on fatigue and viral triggers. The immune system appears to be where the dysfunction lies regardless of the trigger and fatigue is not well enough defined or measured to capture post exertional exhaustion that is clearly different from the fatigue in other diseases. (This doesn’t mean other types of fatigue/diseases cannot be used as comparison groups only that fatigue is a slippery subject.)

    Actually the NIH refusal to fund Dr. Lipkin could be seen in a positive light. The subsequent fundraising attempt was highlighted by both Ed Yong and Mary McKenna on Twitter and they are very well respected – and widely followed – science journos.

    • Jennie Spotila says:

      Thanks, Kelly. I missed Ed Yong and Mary McKenna tweeting about the Lipkin fundraising effort. That’s very good news!!

  2. pat fero says:

    The timeline is troubling. At the NIH State of the Science Meeting (2011???), the lack of research coordination and collaboration glared. In addition I sensed turf competition for funds and after the meeting was over, the hope for better was there, but I thought it would require vast efforts to rework NIH programs to understand these diseases = money. Gaps in the science was discussed for a short segment, really short, then we were done.

    It is true as seen by past grant awards that given additional funds, the money could be awarded to someone studying ANYTHING related to pain, sleep or fatigue symptoms, researchers who have no intention of looking at ME or CFS.

    Tomorrow, I am sending the congressional request for funding mass mailing to all WI members. Each year in Appropriations committees, language appears about ME/CFS. I support ANY increase in funding because we have so little right now AND the pressure is higher to fund appropriate grants. Maybe a few good proposals will be funded. AT least the people on WI lists will have the opportunity to be heard. Most do not use computers.

    BTW, 2 other things. Finding study participants for gutsy research is difficult. We already know that exhaustion will follow exercise and many people are afraid of huge relapse. There are others, like me, aged out. Secondly, publication is a huge challenge. The research has to be sort of mainstream acceptable or the article is rejected. Been that way since early on. In 1998 I sat in on a small meeting with researchers. HAH…big name people published in other areas of study unable to get CFS papers “right” for mainstream journals. No publications. Back to the source. If the editorial board says HAH HAH, then good research is sent back.

    Stating the obvious is easy, keeping the pressure on is much more difficult. Thanks to you all, agree or disagree..making a stink in high places gradually causes the folks there to want it to go away.

  3. John says:

    Goddamn this makes me hot. Researchers know not to apply for funding for ME/CFS research because they have learned by bitter experience that U.S. govt. agencies are incompetent when it comes to just about every aspect of ME/CFS. If a researcher of the caliber of Ian Lipkin can’t even get funding, how the hell is anybody else supposed to and why should they waste valuable time, energy and money trying? Grant applications take time to put together and someone has to be paid while writing them. If you’re just going to be turned down by ignorant and/or incompetent reviewers, why put forth the effort in applying in the first place?

    From Cort Johnson on twitter- “Lipkin got fecal samples, would like to do throat samples, PBMC’s – reviews of his grant proposal to do gut work on ME/CFS were horrendous though, very difficult to get funding, one reviewer of his grant proposal referred to ‘psychogenic illness’ in ME/CFS”.

    I don’t think the CFSAC should change tacks either. Their job is to recommend to DHHS what they think needs to be done. If the NIH needs to issue an RFA for ME/CFS research, then it is CFSAC’s duty to recommend that the NIH issue an RFA. Add other recommendations if you want, but if a recommendation does not get acted on then just make a point to make it again. The need does not go away just because a recommendation doesn’t get acted on, especially a need as important as an RFA.

    I think the CAA is supposed to send out an alert on the NIH RFA Congressional letter this week, hopefully that will help kickstart this important effort. To me it’s not that the NIH doesn’t fund (mostly) good quality biomedical research into ME/CFS, it’s just that they don’t fund near enough of it. From what I’ve seen the NIH doesn’t really hold with the psychobabble nonsense ‘research’ that has historically gotten funding in the UK, Netherlands, etc., so to me there’s no good reason whatsoever to hold off on the RFA request, especially when the pre-requirements that those opposed to the RFA are insisting on (the IOM meeting being cancelled, the CCC being adopted straight-up, etc) might well never even happen. It’s complete nonsense to oppose more funding for research when more funding for research has been one of the ME/CFS community’s biggest problems. The Lights get funding from the NIH, Baraniuk gets funding from the NIH, Shungu gets funding from the NIH, Klimas, Fletcher, Natelson, etc. What if Lipkin’s study got funded with an RFA? What about Kogelnik’s studies?

    Crowdfunding is great, but it should be focused on small pilot studies like the CAA does and then have the big boys like the NIH take over for the big million dollar projects.

  4. kathy d. says:

    Gosh! Dr. Cook sounds like a good guy. I hope he can stay on the Working Group.

    It is disheartening that Dr. Ian Lipkin was turned down for NIH funding when he is really trying everything he can think of to unravel this puzzles of this disease. That he had to do his own fundraising is absurd, but glad he has some support.

    Again, I feel like the HHS and NIH are sending us back to leeches and bloodletting with the modern day equivalent of GET and CBT.

    Something just has to break through this nonscience and lack of funding and proper attention to this disease at this point. So many people with ME/CFS and advocates are speaking out. It has to have an impact on the powers that be. Do they really want to hear us constantly?

  5. Microbe Discovery Project says:

    I hope Jennie doesn’t mind us posting here.

    We’re crowdfunding for Dr Lipkin’s microbiome study.

    You can find out more here:



  6. Anonymous says:

    It seems a doubtful strategy to me to wait for results from IOM and P2P. They may be valuable, but they may well not be. There is useful literature, but if DHHS is determined to survey and represent ALL the literature that exists under the title of CFS, even the stuff that is inapplicable and has fatal methods errors, the report may be not as valuable as we want or even detrimental. There is no way to tell until we see it.

    Of course we can hope it goes well and with some very knowledgeable and passionate people on the IOM committee, this is more likely than if they weren’t there. The rules of engagement might be stacked against them, but maybe they can find a way.

    It’s more difficult to say about P2P because some stages will have no one knowledgeable at all, which is a bit scary and probably a profound mistake.

  7. Chris B. says:

    Does coffee help?

    I find that if I overdo it, and am feeling lousy as a result, drinking coffee helps me _feel_ better. I’m sure it’s fake energy, and I’m careful not to overdo it after I drink coffee. But it makes me feel less tired, and there’s something to be said for that. Is it the same with CFS? My fatigue is from chemo, so it might be a little different then yours.

    • Jennie Spotila says:

      I think the answer really varies from patient to patient. Many patients avoid caffeine because their bodies simply can’t handle it well, while I know others who can’t function without it. For me, I gave up coffee for years because it would aggravate my GI tract. But after new treatments substantially improved that, I started adding coffee back in. It doesn’t help with my physical energy, but it does help me focus better.

  8. kathy d. says:

    For years I could not drink coffee. In fact, I had to give it up early on as it made me feel sick and even tireder. About five years ago, I started drinking iced coffee in hot weather as I had to give up hot tea or anything hot when it’s even remotely hot outside.

    I drink a lot of tea, hot tea in the cold weather, homemade iced tea in the hot weather. I keep caffeinated, decaffeinated and non-caffeinated tea on hand and made three types of iced tea.

    When I really have to go outside of my home and have no energy, I drink iced coffee and sometimes even diet Pepsi — against my better judgment. But those two drinks have gotten me through situations I could not have gotten through otherwise.

    I spent yesterday cleaning out cabinets, wiping myself out. Now today I drank a lot of tea to get moving so I could do anything at home. So I have artificial and short energy.

    I have another problem now: not being able to sleep at all. My usual sleep disorder has turned into a nightmare in the last several months. I’m still wired at 8, even 9 a.m., even 10 a.m. My sleep medications aren’t doing it. But I realize caffeine is contributing to this, so I have to cut back, so thus is the dilemma. And now antihistamines are making me wired all night, even those friends (and pharmacists) say don’t interfere with their sleeping! So, my choices are: sleep, being wired all night, energy (fake as it is) or nothing.

    • Jennie Spotila says:

      Ugh, what a nightmare Kathy. I know many patients who struggle with insomnia like that. One of my good friends does, in fact. And tea is a staple for me. I drink coffee in the morning to get me going, but then have to switch to tea. After after 3pm, no caffeine in any form or my body can’t tell time anymore. I would love to drink coffee all day, but I think my brain would explode. At least, it feels like it would.

  9. Ess says:

    The general ME/CFS population has been given NO medical treatments for recovering from the debilitating energy crisis in our bodies that is such a part of ME/CFS.

    We have been neglected, abused, deprived and hidden away — while the politics play on to keep us buried as the ‘living dead.’

    Happy for you, Chris, that after recovery from the chemo you will get your energy back–that is going to be the best!

    Thankfully, cancer has successful treatments.

    ME/CFS does not. We are the living dead. The HHS and its agencies need to turn this disaster and health crisis around starting NOW!

  10. kathy d. says:

    My making three kinds of iced tea without and without caffeine gets me through the hot weather. Blueberry iced tea (without caffeine) is great with ice.

    What about decaf coffee? Or is there still enough caffeine in it to get you wired?

  11. Ess says:

    To the liquids and beverages part of the conversation–re ME/CFS–On a daily basis my body feels like it is being poisoned. I always feeling dehydrated–and therefore drink about 5 – 6 litres of water daily — plus or including herbal teas, as well as de-caff green tea before bedtime.

    I wonder if all the liquid is needed because it is the body’s way of trying to flush out toxins. Also, always drinking the water helps with the ME/CFS weird headaches (inflammation? /dehydration)

    Those headaches are stronger in the a.m. after waking from a night’s sleep because the body has gone all that time without fluid intake. I drink two large glasses of water on waking. And I am drinking all the way up to bedtime–if I don’t the ‘dehydrated/inflamed’ headache is stronger on waking. (No–this is not diabetes, etc.)

    Caffeinated beverages are an irritant to me–spike up blood pressure, increase headaches and irritate the bowel (IBS).

  12. John says:


    I’m constantly thirsty as well and have heard of other people with this complaint. I wish researchers would compile a symptom profile questionnaire that also asks for other prominent symptoms at the end. I wonder if they would see excessive thirst as a previously unknown/unaccounted for symptom if they did, at least for a subset.

  13. cort says:

    This – They point to the recent denial of funding to Dr. Lipkin as proof that NIH cannot be trusted to make the right grant decisions. – is just crazy!

    Did anyone actually look at NIH ME/CFS grants to see what the NIH IS funding? The grants for the most part are very, very good and that’s the way it’s always been.

    Lest we forget the State of the Knowledge Workshop was designed to point out the gaps in ME/CFS research. It was supposed to prepare the way for an RFA; that RFA obviously hasn’t happened yet.

Comments are closed.