FINALLY: RFA Funding Announced

This post was last updated on September 30, 2017. Edits are clearly indicated in the text.

At long last, NIH has announced the awards of RFA funding to three Collaborative Research Centers and a Data Management and Coordinating Center for ME/CFS. There is not a lot of detail about the grants in NIH’s RePORTer database, and varying levels of detail available from the successful institutions. Here is what we know at this point about the successful Centers.

Cornell ME/CFS Collaborative Research Center, led by Dr. Maureen Hanson. Receiving $9.4 million over five years, Hanson has assembled a star team. Collaborators include ME/CFS researchers Dr. Dikoma Shungu, Dr. Betsy Keller, Dr. Fabien Campagne, and clinicians Dr. Geoffrey Moore, Dr. Susan Levine, and Dr. John Chia. SMCI and Workwell Foundation are also listed on the Center website as collaborators. Dr. Shungu will lead a project using brain imaging to look for evidence of neuroinflammation and oxidative stress associated with ME/CFS. Dr. Hanson will lead a project examining extracellular vesicles for inflammatory signaling. Dr. Andrew Grimson will examine gene regulation defects in white blood cells to characterize the role of the immune system in ME/CFS. All three projects will incorporate the two-day CPET exercise challenge. The grant will be overseen by the National Institute for Neurological Diseases and Stroke (NINDS). 

Center for Solutions for ME/CFS, led by Dr. Ian Lipkin. Receiving $9.6 million over five years, Lipkin will build on his previous work on ME/CFS. According to the project abstract, samples from Lipkin’s existing ME/CFS sample repository will be surveyed for molecular footprints of potential bacterial, fungal, and viral infections, as well as autoantibodies. Another project will analyze metabolites and gene expression in individuals with ME/CFS after physical activity. In addition, existing databases will be mined for insights into clinical features, comorbidities, and sub-types. An innovative project will design a mobile app called myME/CFS that will allow people with ME/CFS to track symptoms in response to stressors and interventions. Collaborators in the center include clinician researchers Dr. Lucinda Bateman, Dr. Anthony Komaroff, Dr. Susan Levine, Dr. Jose Montoya, and Dr. Daniel Peterson. Additional investigators include Dr. Oliver Fiehn, Dr. John Greally, and Dr. Mady Hornig. The Center will also partner with SMCI, #MEAction, and the Microbe Discovery Project. The grant will be overseen by the National Institute of Allergy and Infectious Diseases.

Jackson Laboratory ME/CFS Collaborative Research Center, led by Dr. Derya Unutmaz. Awarded $10.5 million over five years, Unutmaz is a relative newcomer to ME/CFS, with only one grant and no publications in the disease. His collaboration with Dr. Lucinda Bateman and Dr. Suzanne Vernon should provide the necessary expertise. Not much information about the research projects is available yet, but the goal is to assemble, “one of the largest and most highly detailed collections of clinical and biological ME/CFS patient data that can be analyzed using novel computational technologies such as machine learning approaches.” While Unutmaz’s previous NIH grant looks at immune cell subsets, this new Center grant will expand to microbiome, metabolomic and clinical phenotypes. The Center will also partner with Precise.ly for “clinical tracking of the broader patient community.” That description sounds a bit ominous but the company website is focused on a mobile app. This grant will be overseen by NINDS.

Notably, each of these Centers will have some type of advisory committee made up of people with ME and caregivers. That is a huge step forward in our field, and I’m happy to see it.

The Data Management and Coordinating Center grant was awarded to Dr. Rick Williams at the Research Triangle Institute. As of this writing, there is no information in NIH’s RePORTer database about this grant, although the Office of Communications and Public Liaison of NINDS told me that it should be available soon (I’ve removed the name of the person in that office, per NIH’s request that the info be attributed to NIH and not an individual). The Research Triangle Institute does not have a press release about the grant yet, either, and Dr. Williams has not yet responded to my email requesting more information. Dr. Williams was the Principal Investigator for the NIH funding of a Data Coordination Center for the Obstetrical Pharmacology Research Network. The Research Triangle Institute is in the business of implementing and managing coordinating centers for research networks, so presumably the expertise is there. September 20, 2017: edited to add link to the project in NIH RePORTer.

Cort Johnson previously reported that there were ten applications for the Research Centers. Given that NIH stated it would fund only two or three, we knew that there would be some disappointed groups. Who were the losing groups? Based on Cort’s list and my own information, the unsuccessful applications were submitted by:

  • Dr. Ron Davis at the Genome Technology Center at Stanford
  • Dr. Nancy Klimas at the Institute for Neuroimmune Medicine
  • Dr. Lenny Jason at DePaul University
  • Dr. Dane Cook at the University of Wisconsin, Madison
  • Dr. Vincent Lombardi at the Nevada Center for Biomedical Research
  • Dr. Jose Montoya at the Stanford Chronic Fatigue Initiative
  • Dr. Janet Mullington at Harvard University and Beth Israel Deaconess Medical Center

The big surprise loser is Dr. Davis, given that he has twice before had applications turned down for review and has been openly critical of NIH. (Edited to add: see statement from Dr. Davis below) Klimas, Jason, Cook, and Montoya are all experts with significant history of ME/CFS funding and publications, so perhaps it is surprising that Unutmaz (with no ME/CFS publications and one current grant) beat them all. Without seeing all the grant applications themselves, it is impossible to say for certain.

I have a big question about the numbers involved in these grants. The NIH press release states that the investment for fiscal year 2017 will be over $7 million, and this is consistent with what Dr. Vicky Whittemore projected at the CFSAC meeting in January 2017. But here is the funding as described in the NIH database for the projects:

  • Cornell Center: $532,302, correction: $1,868,837
  • Colombia Center: $1,969,576
  • Jackson Lab Center: $517,879, correction: $2,125,950

This totals just $3,019,757, correction: $5,964,363. Where is the other $4 million? The press office at NINDS has not yet responded to my inquiry about that. Update September 27, 2017 at 3:30pm: The press office provided me with the corrected figures in italics above. The new total suggests the data center will receive approximately $1 million in 2017.

Update September 28, 2017 at 9:00am: The dollar figures are still showing some inconsistency. Here’s what I know about the awards at this point:

  • Cornell Center: The Office of Communications and Public Liaison at NINDS told me that the Center will receive $1,868,837 for FY 2017. However, the information available in NIH’s RePORTer (here and here and here and here) totals only $1,147,000. There is $721,837 unaccounted for, at this point. Update 9/28/17, 12:20pm – Dr. Vicky Whittemore confirms the $1.8 million number is correct, and there is project info not yet uploaded to RePORTer.
  • Columbia Center: NINDS told me that the Center will receive $1,969,576, and that matches what is in RePORTer. Unlike the other Centers, this one has all the subprojects linked together on one page.
  • Jackson Lab Center: NINDS told me that the Center will receive $2,125,950 in FY 2017. The information in RePORTer (here and here and here and here) matches that number.
  • Data Management and Coordinating Center: NINDS has not provided me with any information about this grant, saying only that information is uploaded to RePORTer on a rolling basis. Update 9/28/17, 12:20pm – Dr. Vicky Whittemore said the total for the Center grant is $1,260,904.

Is there money missing? Based on the publicly available numbers as I have cited above, there is $721,837 unaccounted for in the Cornell grant, plus at least $1.1 million to get us over $7 million as stated in NIH’s press release. Based on what Dr. Whittemore told me, the total funding under the RFA is $7,225,267.

STATEMENT FROM RON DAVIS, as posted on Phoenix Rising on September 28, 2017 by Janet Dafoe:

Ron says: Our grant had a number of senior scientists at Stanford, including myself, Mark Davis a world renowned immunologist, Mike Snyder, Chair of Stanford Genetics dept, ranked the best genetics department in the world, and expert in big “omics” data, Craig Heller, a world expert in exercise physiology and fatigue, William Robinson MD, expert in autoimmune and Lyme’s disease, Lars Steinmetz, an expert in complex genetics and mitochondria, as well as scientists from other universities, including, Robert Naviaux, USCD, world renowned expert in metabolomics and mitochondria physiology, Curt Scharfe, Yale Univ, expert in mitochondrial genetics, Wenzhong Xiao, Harvard, expert in bioinformatics and big data analysis, Robert Phair, CEO of Integrated Biioinformatics, Inc, which models complex biochemical pathways, Lucinda Bateman, of the Bateman-Horne Center, one of the foremost ME/CFS experts in the country, and Susan Levine, another well-known ME/CFS physician.

One of the major complaints was that I had no publications on ME/CFS. One of the criteria of this RFA was to bring new people into the field, which is impossible if reviewers exclude investigators without prior publications. The team I put together would be phenomenal for this field. All of us have experience and a myriad of publications that are directly relevant to the study of ME/CFS.

The review complained that our institutional environment was “mediocre”. The Stanford office that reviews all Stanford grants told me that they had never seen a Stanford rating anywhere close to that low in their entire history. It’s absurd to think that Stanford is not an excellent institutional environment.

They argued that my involvement with OMF constituted a conflict of interest. In fact, our interests are aligned, not in conflict! This is mystifying given the fact that the RFA required applicants to work with an NGO.

They didn’t like our nano needle instrument. They said it’s probably only measuring cytokines, but there’s no data for that. They said it wasn’t certified as government-approved for medical use with patients. This was mystifying because one of the aims of the grant was to develop the nano needle for medical use!

They complained that Janet was part of the community outreach part of the grant because she is my wife.

They said I had a conflict of interest because my son has ME/CFS.

They didn’t like it that I had put out videos with preliminary results and ideas to the patients on PR and elsewhere because it was unpublished and not peer-reviewed.

There were a number of other criticisms that were mostly about scientific issues, that were mostly wrong. For example, we were proposing to use IPS cells, which they said wasn’t validated, but in fact, it’s used extensively and it’s being used in the NIH Intramural study!

This is not a complete list, but I think you can get the picture from these examples.

We of course will continue to write grants until NIH funds us (we are submitting an R01 grant on Oct 5), and we will continue to actively work with OMF to raise private donations, but this is definitely a big setback. I was especially sad on Monday when Whitney was communicating with us on ativan and he cried in pure anguish, knowing that we can’t help him as fast as I’d like to.

I’ll update this entry with additional information when it becomes available.

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23 Responses to FINALLY: RFA Funding Announced

  1. Denise says:

    Thank you for taking the time/resources to parse all of this and make this analysis available to us (SO quickly also)! You are amazing!

  2. I would have rather seen Davis, Klimas, and Montoya as winners.

    Funding – but giving the money to places that have to start farther back – still seems like dissing the researchers already in the field.

    But what the heck do I know?

    Thanks for the information – and your commitment to keep going after it. I still don’t see where you find the energy.

  3. Alan says:

    The Univ. of Connecticut Medical School in Farmington was one of the leading proponents of the biopsychosocial model for ME/CFS in the 1990s and early 2000s.
    I believe the Jackson Laboratories facility is on their campus. It seems Jackson Labs have had little involvement with ME/CFS. I believe they need to be carefully watched and the leaders interviewed.

  4. Chris says:

    Thanks for a well-written summary! The study section and/or NIH council went political, as is the case with many things in life. The patients are the biggest losers.

  5. Janelle says:

    Thanks for the article. 🙂

  6. Pingback: ME/CFS Collaborative Research Centers & Data Management Center Announcements – The Microbe Discovery Project

  7. Joe Landson says:

    We’re still in Tale of Two Cities, aren’t we? It’s the best of times, it’s the worst of times.
    On one hand, there is finally funding. On the other, Ron Davis’ groundbreaking work is being rejected because he dares to rock the boat. That’s the real reason. The given reasons above are insipid lies. I’m very happy for Maureen Hanson, but she’s also the parent of a person with ME, so that fact hardly disqualifies Ron. He’s being lied to, and so are we, still.
    Finally, for all the research advances, not a thing has changed in the daily, doubted lives of people with ME. Nor will it likely change soon, since that (apparently) would have be approved by a committee in Bethesda that hasn’t even been formed yet.

  8. Rivka says:

    What the *&^$#@! is their institutional bias against Ron Davis?

  9. Rivka says:

    Is he being punished for being a concerned parent? For speaking out to the NIH?

  10. Rivka says:

    People with ME, activists and advocates: If you are able, now would be a great time to donate to Ron’s foundation that funds his lab. They must relay on private donations. If you can help, please do. https://www.omf.ngo/donate-to-the-end-mecfs-project/

    • anonymus says:

      Ditto to all of Rivka’s comments. The NIH funding allocated to ME (or lack thereof) is criminal, but shocking and infuriating that Dr. Davis didn’t receive funding.

      Incredible job, Jennie! Thank you for taking your incredibly limited energy and time to get this together so fast.

  11. Patricia Fero says:

    Thanks Jennie,

    WAY to go after those numbers and double check the amounts. Now we see if money is spent where it was directed. I suspect that these researchers are far above many in the past and our money will not be misappropriated for some pet interest.

    We did not have these collaborations previously and it is wonderful to see. I, too am disappointed that more money was not made available for other worthy grants. Some of the comments about the Davis Grant are downright odd.
    Thanks!

  12. Kathy D. says:

    I agree with the above sentiments. Thank you so much for your hard work in breaking this down and following up with Dr. Vicki Whittemore.

    I echo the comments by others: Why didn’t Ron Davis, Nancy Klimas and Jose Montoya get grand funds? Especially Ron Davis!

    My heart is breaking thinking about his dedication to finding a cause and treatment for his son and others with severe ME/CFS. How terrible to have to tell his son his work wasn’t funded by the NIH when he knows more about this disease than many, and he’s dedicated to figuring this out.

    He does not have a conflict of interest in that his son is severely ill or that his spouse, Janet Dafoe, is a community advocate. What the heck? So grossly unfair.

    I wish that a lot of donations will go his way, and I will send him a donation and a note of support.

    Meanwhile, for those who didn’t know, Jen Brea and Omar Wasow were on Megyn Kelly’s third hour of the Today show on Sept. 28, discussing her illness and her “Unrest” film. NBC’s doctor, Natalie Azar, was on the show for a minute, validating the disease.

    Advocacy and this film are making inroads.

  13. Maureen M says:

    As always with your blogs, so clearly written and extremely informative.

    Joe Landson certainly hit the nail on the head with his “It was the best of times, it was the worst of times” ‘ Tale of Two Cities’ comment. Glad for those funded, but extremely disappointed about those not, and particularly so with some of the reasoning emerging.

    In all our current (justified) angst I did not want to let your small comment and link to your April blog and resource, Best Practices for ME Patient Partners go unnoticed. Somehow I missed reading the Best Practices #MEAction document in April. It contains a wealth of useful information and suggestions and should be a must read for patients and researchers alike.

  14. deboruth says:

    I believe Jackson, Connecticut has been connected with Fred Friedberg the head of IACFSME on psych-linked projects. Check Fred’s grants on Grantome. But that’s what I remember.

  15. I’m fuming mad, but trying to think of ways to combat this continuation of bad behavior on the part of NIH reviewers. This is unacceptable.

    Thoughts:
    Can we protest NIH about this and make demands?
    Can Ron’s statement go public on social media?
    Can we point a finger at NIH with his statement?
    What else can we do?

    Phissed off in Phoenix

  16. Mary says:

    Great summary! – is the roughly $7 million annually for the RFA funding in addition to the roughly $7 million already budgeted for ME/CFS by the NIH (https://report.nih.gov/categorical_spending.aspx) or is it the same thing?

  17. Els says:

    Don’t give up, stay strong; we need help. I admire your courage, as well as the courage of your son, of your wife, of your family. Because of that I don’t lose mine completely

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