The NIH Plan

Green-Start-Now-Button(updated November 9, 2015)

Unless you have been avoiding the internet for the last week, you already know that NIH has made a big announcement regarding its plans for ME/CFS research. Dr. Francis Collins has made some remarkable and welcome statements in the press:

Given the seriousness of the condition, I don’t think we have focused enough of our attention on this. (from The Atlantic)

Give us a chance to prove we’re serious, because we are. (from Science Insider)

Personally, I have waited a very long time to hear the Director of NIH make statements like this. But the details of the new plan are of primary importance, and sometimes difficult to come by.

The biggest news, in my opinion, was first mentioned in the Science Insider piece: that a new request for proposals would be issued for extramural research. In an NPR article today, Dr. Collins said that “It will be substantially greater than the current five or six million a year. We are going to ramp this up.” This is huge progress, especially if the new request is an RFA, because those have a guaranteed amount of money attached.

Researchers and advocates have been asking for an RFA for the last ten years, so the confirmation that we may finally get one is extraordinarily good news. But the real question is whether NIH and advocates define “substantially more” the same way. The last requests from the CFS Advisory Committee, the IACFS/ME, and members of Congress were for $7-10 million, and perhaps that would be a realistic expectation. But given the needs identified in the P2P report, and the thirty years ME/CFS research has spent in Siberia (as Bob Miller put it), I’m not sure we can cry victory over that kind of number. It also matters how well targeted the request for proposals is, especially in terms of case definition and types of studies. Fatigue research won’t cut it, in my opinion. Dr. Collins said the idea is to award the money in FY2016, so we should get these details soon.

The second piece of good news, confirmed on NPR today, (see update below) is that ME/CFS research will be overseen by the National Institute of Neurological Diseases and Stroke. There was initially confusion about whether this meant just the  Trans-NIH ME/CFS Working Group would move, or whether ME/CFS research itself was going to have a home at the Institute. Having an Institute home is extremely important, for three reasons:

First, being assigned to an Institute means that ME/CFS will be included in an Institute’s strategic plan. To my knowledge, that has never happened. As NIH moves increasingly towards use of strategic plans to guide funding decisions and reporting to Congress, having someone thinking about ME/CFS in that context is critical.

Second, being assigned to an Institute means that ME/CFS has a chance at getting a piece of the Institute’s budget. The Office of Research on Women’s Health, where we’ve been for many years, does not have a research budget. In 2014, funding for ME/CFS research grants was cobbled together from four Institutes (NINDS, NIAID, NIMH, NINR) and the Office of the Director. We’re not talking a lot of money, so that represents tiny investments from each of those sources. Undoubtedly other Institutes will continue to be relevant in funding ME/CFS research (especially NIAID), but having a home gives us a chance at a bigger slice.

Third, being assigned to an Institute should mean that ME/CFS will have an assigned Program Officer. The importance of this cannot be overstated. Program Officers are research portfolio managers at NIH, assigned to specific areas of focus. They write Program Announcements and Requests for Applications. They monitor grants once awarded. They must stay current on developments in their assignment areas and interact with the research community. After grant applications are reviewed (in our case by the CFS Special Emphasis Panel), Program Officers make funding recommendations to their Institute Councils. In other words, a good Program Officer is indispensable to research progress. (Here’s a great first hand account of being a Program Officer).

In 2014, seven different program officers oversaw ME/CFS grants. Seven. That does not mean we had seven people staying abreast of ME/CFS research and managing a portfolio. It means that no single program officer was responsible for doing so. And that is a huge loss. It is one of the barriers to the success of ME/CFS researchers in applying for NIH funding. The good news is that Dr. Vicky Whittemore at NINDS managed more 2014 ME/CFS grants than anyone else (five), followed by Dr. Timothy Gondre-Lewis at NIAID (three). So if Dr. Whittemore is assigned to be the ME/CFS program officer, we have a head start. The caveat is that she is already the program director for epilepsy, so it’s not likely she’ll be working on ME/CFS full time. But it’s a start.

Third, a new study at the NIH Clinical Care Center will bring the latest technology to bear on the “clinical and biological characteristics of ME/CFS following a probable infection” (that’s from the press release). We don’t know many details about the study, but the Clinical Care Center is one of the best medical facilities in the country, if not the world. Bringing in ME/CFS patients and working them up with every possible test is a great idea, and has been needed for a very long time.

We don’t know how much money will be invested, but the NPR story does say it will include 40 patients. We don’t know how patients will be selected. The Atlantic reported that the study will focus on patients left “permanently impaired” after an acute illness, but the NIH press release said that the study “plans to enroll individuals who developed fatigue following a rapid onset of symptoms suggestive of an acute infection.” (emphasis added) We don’t know if the study will focus on the newly ill, or what case definition(s) will be employed. And it’s likely that some of these decisions have not actually been made yet. We’ll have to watch how the protocol develops, and what testing is used. This study has incredible potential to yield the answers we need, if it is appropriately designed.

Here’s the bottom line of the NIH announcement: It’s a promising start. There are a lot of details we need to know. And until we actually see how much money is on the table and how it’s spent, we can’t judge the quality of the effort.

As Dr. Collins told Science Insider, “Give us a chance to prove we’re serious, because we are.”

Ok. Let’s do this. We’ve waited long enough.

Update November 7, 2015: I continue to hear conflicting reports about whether ME/CFS research will be overseen by NINDS, including having a single program officer and being included in the NINDS strategic plan. Sources who have spoken directly to NIH continue to report different answers to this question. I’m not sure if the explanation is a lack of clarity at NIH, or that advocates don’t speak NIH’s language such that people are interpreting answers differently. I think we will have to wait and see how this plays out. If we are not included in NINDS’s strategic plan or if we do not see someone step forward to truly manage an ME/CFS portfolio, then we’re quibbling about semantics instead of solving the problem.

Update November 9, 2015: Cort Johnson spoke with Dr. Vicky Whittemore and reports that she said: “To be clear, no one NIH institute, office or center has single oversight for research on ME/CFS. We will work together through the Trans-NIH ME/CFS Research Working Group to coordinate, stimulate and support research.” That sounds to me like we do not have an Institute home the way other diseases do. We are going to have to wait and see how this plays out in order to just whether this is a good development or not.

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23 Responses to The NIH Plan

  1. Joe Landson says:

    That’ll be great if the intramural study has 40 people. Because then, the next NIH evidence review can exclude it for being too small… :-/

  2. cort johnson says:

    Nicely done Jennie. I’m investigating how far we’re into NINDS we are. I don’t think we’re as far in as is thought but I do think that Collins is backing this strongly and that’s very important.

    We’re starting from a very low spot and it’s going to take time – more time than we’d like – but we are moving forward for the first time in almost two decades.

  3. Flora says:

    What is an RFA? I missed that bit.

  4. Chris Heppner says:

    Jennie, many thanks for filling in some of the details (clearly there will be more to come) on what has to be great news–just how it will work out remains to be seen, as you point out, but this does seem a really major step forwards. And thanks to you for all the great work you have done over the years to help trigger this!

  5. billie moore says:

    I was ecstatic when the first news broke and indicated we were to be housed in NINDS – National Institute for Neurological Diseases and Stroke. However, it later turned out, as Jennie describes, that this is not quite what is happening. So now I take the opposite view – what Dr. Collins has announced last week is far better than the pokes in the eyes that we are used to, but the disease is still an orphan. No Institute seems to have been willing to fully claim us yet. Maybe this is still too big a step for the NIH; to bring the disease into an Institute under the criteria Jennie outlines would indicate that they really do believe that ME/cfs is a serious, multi-system disease which needs much more attention. It is a very ambiguous announcement, that’s for sure.

    Flora, an RFA is Requests for Applications for research grants through the NIH.

    • Jennie Spotila says:

      Billie, the answer to whether we are housed at NINDS keeps shifting depending on who is talking. I *think* the NPR story means NINDS is actually taking us, but it sure would be nice to get a direct quote from NIH on that.

  6. Cindy Shepler says:

    Excellent article! Thanks for explaining the details and for all of your advocacy work, Jennie!

  7. Tina says:

    What happened to the claim that extramural research funding is determined by the number of food applications, and this disease doesn’t get enough to have more funding? What other mechanism is available? And if something else is available for more extramural funding, then why didn’t anyone tell us this for the decades we’ve been asking for more funding? Don’t tell me more extramural funding just required Collins wanting to do it. If that’s the case, we’ve been lied to, year after year. I’ll be interested in seeing how this big increase in extramural funds comes about in addition to the amount.

  8. billie moore says:


    I will now only be satisfied if the information comes from the NIH and they make it perfectly clear (underline, italics, red print) that we have been adopted in NINDS according to all of the criteria you list. And thank you for this very useful post. Glad to have you back!

  9. Kathy D. says:

    Jennie, so glad you’re back in business.

    I kept checking in to see if you had written on these new developments with the
    NIH. Although I knew the basics, much of what you cite and include here I had not seen.

    It’s been hard for me to see how the NIH could ignore the IOM report forever, the op-ed written in the Washington Post by a former writer who has ME/CFS, and the article about Whitney Dafoe who is totally disabled by the disease, and whose father is a scientist at Stanford and is setting up a research program with the aid of 3 Nobel Laureates. Then there was the article in the Atlantic.

    The article about Dafoe was a real shocker to anyone who is in denial about the seriousness of this disease. And that his father, Ron Davis, was on the IOM committee and is now adamant about researching the disease — and was denied money from the NIH — really put the NIH in a bad light. That must have been
    a motivator here.

    Whatever the impetus, it’s good to see this development. However, I still think, “Show me the money!” is key And also, under whose aegis will the research and follow-up be carried out?

    Hope your spouse is better. Glad you’re able to blog and follow all of this.

  10. Cheryl says:

    Time to strike while the proverbial iron is hot and put pressure on Congress for more funding. Please write, call, email, tweet, FB your Congressional Reps in both House and Senate. If you are able to also contact those on the Health appropriations committee all the better. Here is a link to all the Congressional Committee members.
    If you go to PR, there is a thread on twittering and I have all member of appropriate committees twitter handles listed to cut and paste.

  11. Lolly says:

    NIH invited me to join the Lyme Study (with newly acquired Encephaletic Lyme) during the early summer of 1998, 3-5 weeks after tick bite, but more that 13 years after my original M.E. diagnosis. For 17 years now I have walked the path where Post Treatment Lyme Syndrome intersected with ME/CFS. I can not tell you how grateful I am to these wonderful committed researchers who over and over again during the annual follow-ups would carefully watch me, and then say something is different and move forward to define the issue. Today, although not “cured” and not exactly like so many of the other ME/ CFS patients I cannot think of a better out come of the recent meetings. Thank you to all who worked so hard to make this new opportunity a reality.

  12. Jim Mills says:

    I agree with your comment that “…until we actually see how much money is on the table and how it’s spent, we can’t judge the quality of the effort.”

    The amount of funding for ME research is critical. It will be a key factor in determining if a cure for ME will be developed.

    As we all know, a major factor in the lack of progress in finding treatments and a cure over the past thirty (30) years has been the minimal number of dollars allocated by NIH to ME medical research. In 2014, 95% of NIH “Research/Disease Areas” received funding greater than the $5 million support level for ME.

    This must change.

    I fervently hope that Dr. Collins follows through on his statement to NPR/Shots that “(w)e are going to ramp this up.” (11-4-2015)

    CFSAC recommended to Secretary Burwell in August, 2015 that “… equitable funding is estimated to be $250,000,000 per year.” (Page 9)

    I believe the $250,000,000 should be considered the MINIMUM AMOUNT of NIH funding per year for medical research to cure ME/CFS.

    The August, 2015 CFSAC report contrasted the “mere $5 per patient” (assuming 1,000,000 patients) funding level of ME to the NIH funding for MS at $255 per patient and funding for HIV/AIDS at $2,482 per patient. (Page 10)

    Based upon the IOM statement that between 836,000 and 2.5 million Americans have ME, the range of funding to be comparable to MS funding should be between $213,180,000 and $637,500,000 and the range of funding to be comparable to HIV/AIDS funding should be between $2,074,952,000 and $6,205,000,000.

    The number of individuals afflicted by ME, the fact that the level of disability is similar to both MS and HIV/AIDS, and the minimal amount of NIH funding over the past thirty (30) years, justifies NIH funding for ME research far in excess of $250,000,000 per year.

    I have written to Secretary Burwell, Dr. Francis Collins, Dr. Walter Koroshetz, and Dr. Vicky Whittemore, as well as my Congressional delegation, explaining my reasons that NIH needs to fund ME research in a dollar amount that achieves parity, on a per patient basis, with other illnesses of similar severity and disability.

    Jim Mills

  13. Denise says:

    “If we are not included in NINDS’s strategic plan or if we do not see someone step forward to truly manage an ME/CFS portfolio, then we’re quibbling about semantics instead of solving the problem.”
    This is SO true!

    We need to know details. I am all ears NIH.

  14. Pingback: アメリカ国立衛生研究所(NIH) 慢性疲労症候群(ME/CFS/SEID)研究立上げ | 5 STRINGS

  15. Anne Ö says:

    I want to echo Kathy D’s comment:

    I’m so glad you’re back in business!

  16. Denise says:

    So it seems we have no NIH institute home, which among other things means we won’t be included in any institute’s strategic plan, won’t have access to any institute’s budget, won’t have an assigned Program Officer.

    I hope that what Collins is talking about actually amounts to something of significance for us.

    For instance, NIH could announce that they will double the cfs budget and that would sound terrific until people realize that that’s still a pittance compared to MS, Lupus, etc. But being able to say that they doubled the cfs budget would come across as pretty amazing to outsiders.
    For us to be able to drive home the point that doubling that budget (if that’s what happens) still is nowhere near what we need for the research that will move things forward for us would be difficult because of the extensive bias in most media. For advocates who are so scattered, it would be very difficult to get out the message that a doubling of the budget is still way too little to accomplish what is needed.

    The study at the NIH Clinical Care Center – we need lots of details about the study. From what I have seen, it will have 40 participants. One of the things we get told repeatedly is that research studies on this disease have usually been too small to draw conclusions from and this study, with only 40 participants would be no exception.
    NIH should instead fund a study that has sufficient power to provide signals!

    Collins is 65 years old and has been in his NIH position since 2009. He says that he has been very concerned about this disease since he started at NIH but for instance, nothing happened at NIH as a result of the State of the Knowledge Workshop in 2011.
    So is his interest in this disease heightened because of the P2P and IOM reports ? Perhaps.
    Is it because of Ron Davis talking to Collins as has been reported? Maybe.
    But Lipkin has Collins’ ear and has talked to him about this disease and that hasn’t done anything. So I don’t know if one can say that the impetus is the personal connection to eminent researchers.

    So the cynic in me wonders if Collins is planning his departure from NIH and knows that if he pushes a bit on things related to this disease now, there will be fewer repercussions for him since he is leaving. (I have no indication that he is leaving – just wondering.)

    And if Collins is leaving, how will pressure be sustained to ensure that appropriate funding/research etc continue to be available to move things forward for this disease?

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