REPORT PART 1: NIH IS NOT ADVANCING ME/CFS RESEARCH

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The NIH is doing little to expedite a coordinated, outcomes-focused plan for ME/CFS research, an enormous missed opportunity in the era of COVID-19.

Editor’s note: This is part of a report series on what the NIH is (and isn’t) doing for ME/CFS and long COVID research. For our Report Summary see here. For Report Part 2: NIH Lacks Coordinated Response for Long COVID Research see here.


ME/CFS researchers have produced the most advanced knowledge on multi-system, post-viral illness to date. As David Tuller and Steven Lubet wrote in their recent article for STAT, “ME/CFS could hold keys to understanding the long-term health consequences of COVID-19.” Despite the increased urgency, our information-gathering shows that the NIH is doing little to expedite ME/CFS research in a coordinated, outcomes-focused way. As far as we know, they haven’t taken any real steps toward creating a Strategic Plan for ME/CFS, which was a “key recommendation” from the NANDS Working Group. It is doing little to fund or conduct ME/CFS research into diagnostic biomarkers and treatments, or to advance programs on an urgent timeline. We appreciate the information that the NIH shared with us. Any opinions expressed are solely those of #MEAction.

OUTLINE

  1. The NIH is doing little to fund ME/CFS Research 
  2. The NIH is doing nothing to expedite ME/CFS grant application reviews 
  3. The NIH is doing nothing to prioritize the release of findings from their ME/CFS Clinical Study
  4. The NIH is not taking a systemic approach to increasing community engagement

1. The NIH is doing little to fund ME/CFS Research

ME/CFS research could hold important keys to understanding the long-term consequences of COVID-19, creating an urgent need to increase ME/CFS funding now. Despite this need, NIH leadership continues to ignore community demands for new set-aside ME/CFS research funding (RFAs). There is one small opportunity for researchers with a current NIH grant. Extramural researchers who currently hold grants with the NIH and who wish to study the biologic effects of SARS-CoV-2 on the nervous system can apply for administrative supplements and competitive revisions. This opportunity is an add-on: it adds additional funds for studying SARS-CoV-2 to their existing grants. These applications were last reviewed the week of June 22. Applicants who have not heard yet should find out whether they are getting awarded within the next several weeks. This supplement may help several ME/CFS researchers establish a new cohort in their current studies for better understanding the link between COVID-19 and ME/CFS, but it is far from the systemic infusion of funding necessary for ME/CFS research right now. The NIH staff have had multiple, ongoing discussions with researchers about their interests in studying both patients with COVID-19 who go on to develop ME/CFS, as well as patients with ME/CFS who subsequently contract COVID-19. They have discussed ways to incorporate studies on COVID-19 into their ongoing research and new research, including with the Directors at the three ME/CFS Collaborative Research Centers (CRCs) and the Data Management Coordinating Center, all established in 2017 with NIH funding. But, the NIH leadership has not created any new set-aside funding for the many qualified ME/CFS researchers without a current NIH grant, nor have they increased funding to the three CRCs to the level that makes sense given the urgent need to understand post-infectious disease states, nor are they funding new CRCs.

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2. The NIH is doing nothing to expedite ME/CFS grant application reviews

NIH leadership is not expediting the ME/CFS grant review and approval process in any way, despite the scientific and clinical care community’s widespread expectation that ME/CFS cases will spike in the coming months due to COVID-19. For a brief summary on how the current grant application review cycle works, see endnote.1 Researchers can continue to apply for the stand-alone grants announced in April 2020, such as R01s and R21s, which have no set-aside funding. The latest round of applications were due June 5th; no information is available on the total number received. They aren’t scheduled to be reviewed until Fall 2020, and they won’t be funded until April 2021, after council review by the institute most relevant to the research application. In other words, despite the urgent need for ME/CFS research now, researchers who recently applied will not know if they are funded for another 9 months, at which point the opportunity to conduct large prospective studies on COVID-19 sequelae will have mostly passed.

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3. The NIH is doing nothing to prioritize the release of findings from their ME/CFS Clinical Study

There is still no indication of when any findings from the NIH’s Intramural ME/CFS Clinical Study will be released, even though in-depth findings from ME/CFS research is urgently needed to address the long COVID crisis. Dr. Avindra Nath, Principal Investigator of this study, has reams of data that he and other experts – including some in microbiome, immunology, and proteomics specialties – are continuing to analyze and streamline. Dr. Nath is also currently developing an artificial intelligence system for more efficient data analysis. Unfortunately, there are no timelines for the completion of these analyses. The NIH leadership has done nothing to support overstretched researchers and staff to arrive at their findings in an expedited manner.

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4. The NIH is not taking a systemic approach to increasing community engagement

We know that a proactive, systemic approach to the long COVID crisis should include community engagement in every stage of disease research – from protocol design to recruitment to publication. But the NIH is a long way from achieving this. For example, the RFAs for the three CRCs established in 2017 required “community engagement and participation” in the research process, but there has been little follow through on this mandate. To date, NIH community engagement has consisted of just three, 1-hour community calls per year, hardly a systemic approach to community involvement. In the area of community engagement, the new Interagency Working Group, which was a recommended strategy of the Report on the NANDS Working Group for ME/CFS Research, is soon launching. The group will have participants from federal agencies, as well as from non-profits including #MEAction, Open Medicine Foundation (OMF), and Solve ME/CFS Initiative. Its official aim is to identify ME/CFS-related questions and issues and work together on solutions. However, the agenda for the first 2-hour meeting announced to take place on August 11 is limited to updates from federal agencies and a panel with participants from non-profit organizations. For more information on this meeting, which the community can view live visit the event page.

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ENDNOTE

1 NIH grant applications that are focused on ME/CFS continue to be evaluated by the ME/CFS Special Emphasis Panel (SEP), which meets three times a year. The ME/CFS SEP as a mechanism for reviewing ME/CFS research grant applications is an improvement from past decades, as ME/CFS experts sit on the panel and score the applications that come in. The NIH’s Center for Scientific Review (CSR) recently stopped sharing the names of the SEP roster, which is a worrying step backward with regards to transparency. Grant applications that include ME/CFS but aren’t focused on the disease usually get assigned to the NIH institute most relevant to the study, as opposed to getting assigned to the ME/CFS SEP. If a study has a substantial ME/CFS component, the NIH ME/CFS program has a system in place to track it and get it reassigned to the SEP so ME/CFS experts can review the grant. This, too, is a big improvement from historical review processes at the NIH.

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This is part 1 of a two-part reporting series by #MEAction on research at the NIH. 

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