On February 13, 2026, we sent a formal letter to the Director of the National Institutes of Health urging decisive action on the ME/CFS Research Roadmap and its required implementation plan. The letter highlights a rare moment of alignment: clear Congressional direction, NIH’s own completed Roadmap, and renewed institute-level recognition of ME/CFS as a serious biomedical condition. Our message is that this is an opportunity to move from language and frameworks to measurable execution.

Drawing on input from leading ME/CFS clinicians and researchers, the letter outlines concrete, achievable priorities for NIH. These include publishing a time-bound implementation plan with clear ownership, building core research infrastructure such as a national cohort and biobank, launching a dedicated clinical trials pipeline, accelerating development of clinically meaningful biomarkers and diagnostic tools, and embedding people with lived experience throughout the process. Together, these steps would address long-standing structural barriers that have suppressed the field and discouraged investigator participation.

For decades, people with ME/CFS have watched promising moments dissipate without durable follow through. This letter reflects what people with ME/CFS, clinicians, and scientists have consistently said is needed: clarity, accountability, and visible commitment. We remain focused on ensuring that the Roadmap becomes a catalyst for real progress rather than another document that acknowledges the problem without changing outcomes.

HERE'S THE LETTER:

February 13, 2026

Jay Bhattacharya, M.D., Ph.D.
Director
National Institutes of Health
U.S. Department of Health and Human Services
9000 Rockville Pike
Bethesda, MD 20892

Dear Dr. Bhattacharya:

Congratulations on your appointment as Director of the National Institutes of Health. We are writing to underscore NIH’s opportunity to follow through on the recently-passed fiscal year (FY) 2026 Labor–HHS appropriations bill (specifically, Senate Report 119-55), which encourages NIH to advance the priority research areas identified in the ME/CFS Research Roadmap and directs NIH to provide a detailed Roadmap implementation plan within 180 days of enactment.

That directive now lands alongside your significant public commitment in Nature Medicine outlining a new strategic vision for NIAID—one that explicitly includes myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) among the long-term post-infectious and non-infectious inflammatory syndromes NIAID will foster research to better understand. We applaud NIH and NIAID for making that commitment clearly and directly.

The Roadmap is how NIH can translate both Congress’s directive and the vision you’ve outlined in into real-world execution. NIH has already completed and approved the ME/CFS Research Roadmap after a rigorous, community-engaged process, outlining clear priorities for biomarkers, diagnostic tools, and clinical trials. This letter—informed by input from leading ME/CFS clinicians and researchers—offers practical, expert-informed recommendations that can be incorporated into NIH’s required implementation plan so the next steps are clear, measurable, and owned.

We also want to be direct about what has kept ME/CFS research from scaling in the United States. Because ME/CFS has been chronically underfunded, the research community has been suppressed— fewer funded teams, thinner pipelines of early-career investigators, and a track record that has made even highly respected experts in viral and post-viral disease reluctant to devote the time and resources required to prepare grant applications without clear evidence NIH is actively seeking this work. In other words, strong language and strong vision are necessary, but researchers also need clear signals that ME/CFS proposals are welcome and competitive, and that NIH will put real mechanisms behind the Roadmap.

As NIH finalizes the Roadmap implementation plan directed by Senate Report 119-55, it should do so with a clear-eyed view of the global landscape: international peers are scaling investments in post- infectious disease research at levels commensurate with the burden. Germany has announced a €500million commitment to research on Long COVID and ME/CFS over the coming decade. The United States should continue to lead globally in biomedical innovation—and that leadership will be measured in part by whether NIH translates major research frameworks for diseases like ME/CFS into concrete, time-bound implementation.

We also recognize NIH is navigating institute-level leadership transitions and evolving decisions about how best to anchor and coordinate ME/CFS research across Institutes and Centers—including
increased institute-level emphasis signaled within NIAID and leadership changes at NINDS following the departure of Dr. Walter J. Koroshetz. While we are open to where ME/CFS is anchored across NIH, what is non-negotiable is clear ownership and accountability for execution. NIH’s implementation plan should clearly assign senior-level responsibility for Roadmap execution, preserve continuity
through transitions, and ensure this work does not lose momentum during any realignment.

Accordingly, we urge NIH to use the implementation plan required by Congress to do more than restate the Roadmap’s priorities but to operationalize them. Below are five concrete recommendations NIH can incorporate directly into the plan to define leadership and governance, establish core infrastructure, launch a clinical trials pipeline, accelerate biomarker and diagnostic development, and ensure ongoing engagement with people with lived experience and treating clinicians.

1. Publish a time-bound ME/CFS Roadmap implementation plan with clear ownership, milestones, and mechanisms.

We encourage NIH to translate the Roadmap into a public implementation plan that specifies which Institutes and Centers will lead each major line of work, the mechanisms that will be used (e.g., RFAs, cooperative agreements, contracts, intramural initiatives), and near-, medium-, and longer-term milestones. The plan should make clear how ME/CFS-focused work will be coordinated with, but not
subsumed under, broader post-acute infection and Long COVID initiatives. A transparent implementation plan, responsive to the Senate directive, would give Congress, patients, and the research community a clear line of sight into how NIH intends to operationalize the Roadmap and guide internal prioritization of future funding announcements.

The plan should also directly address a core challenge the field has faced for years: researchers need a clear invitation and a credible pathway to apply for ME/CFS work. In addition to describing scientific priorities, NIH should use the implementation plan to provide the research community with confidence that ME/CFS applications are truly welcomed—by clarifying what kinds of opportunities will be available and on what timeline, and by describing how applications will be reviewed so proposals are evaluated with appropriate scientific expertise.

2. Build core ME/CFS research infrastructure: a national cohort, biobank, and standardized measures that support biomarker discovery and diagnostic tool development.

The Roadmap highlights the need for large, carefully characterized ME/CFS cohorts and linked biorepositories, accompanied by standardized measures of illness. We recommend that NIH support a national ME/CFS cohort recruited across disease duration and severity (including homebound and bedbound patients), and onset triggers, with a harmonized core set of clinical, functional, autonomic,and patient-reported data elements. Linked to this cohort, NIH should establish a central or tightly coordinated biobank network with common standards for collection, processing, storage, and access.

This infrastructure should explicitly support biomarker discovery and validation across immune, metabolic, autonomic, vascular, genetic, and microbiome domains, and it should be designed from the outset with the goal of developing diagnostic tools that can be deployed in real-world clinical settings.

Requiring use of harmonized measures and careful characterization of participants as a condition of funding will lower barriers for new investigators, improve reproducibility, and create a foundation for future clinical trials.

3. Stand up a dedicated ME/CFS clinical trials program, integrated with post-acute infection platforms but preserving disease-specific analyses and arms.

The Roadmap concludes that there is sufficient scientific rationale to initiate exploratory and larger controlled clinical trials in ME/CFS, including trials of repurposed therapies grounded in observed immune, autonomic, metabolic, and vascular abnormalities. We recommend that NIH establish a modest ME/CFS clinical trials network, linked to the cohort and biobank described above, and issue RFAs for phase 1/2 and phase 2/3 trials of mechanistically informed interventions. For illustration, interventions already evaluated in ME/CFS and/or currently being studied in contemporary trials include rintatolimod (Ampligen), valganciclovir, pyridostigmine (Mestinon), and low-dose naltrexone, among others. These examples are illustrative and non-exhaustive; NIH should prioritize specific candidate agents through standard peer review and biomarker-informed stratification, consistent with the Roadmap’s emphasis on heterogeneity. Trials should incorporate prespecified mechanistic endpoints—alongside patient-centered outcomes such as activity tolerance, orthostatic tolerance, cognitive function, and quality of life—to help explain heterogeneity in response and refine future trial design.

Given the overlap between ME/CFS and Long COVID, ME/CFS should be deliberately integrated into existing and future post-acute infection platforms, including treatment trials, using shared instruments and assays. At the same time, ME/CFS must not be treated solely as a subset of Long COVID. Where feasible, studies should compare ME/CFS, Long COVID, and other post-acute infection syndromes side-by-side, so that both shared and distinct mechanisms and treatment responses can be identified. This approach leverages existing investments while respecting the decades-long burden faced by people with ME/CFS.

To help rebuild the clinical research pipeline, NIH should also consider ways for clinical trials planning and start-up work to begin quickly—so researchers can see a credible path from proposal to launch, rather than an open-ended process that further discourages participation.

4. Prioritize a focused push on clinically meaningful biomarkers and diagnostic tools.

The Roadmap repeatedly underscores that robust biomarkers and additional objective markers are central to improving diagnosis, phenotyping, and trial design. To accelerate progress, we recommend that NIH fund multi-site validation studies of leading biomarker candidates—spanning immune, metabolic, autonomic, cerebrovascular, and microbiome-related measures—using harmonized protocols across centers and linking these efforts to the national cohort and biobank. At the same time, NIH should prioritize development of clinically deployable tools, including refined autonomictesting, low-burden functional assessments, imaging approaches, and laboratory panels that can realistically be used by primary-care and specialty clinicians. Focusing on biomarkers and tools that are both informative and implementable will reduce diagnostic delay, enable more precise stratification, and support objective monitoring of treatment response.

5. Embed people with lived experience and front-line clinical expertise throughout implementation.

The Roadmap’s development process was notable for its extensive engagement of people with lived experience of ME/CFS, caregivers, clinicians, and advocates. That model should be carried forward into the implementation phase. We recommend that NIH establish a standing ME/CFS implementation advisory group—including people with lived experience, caregivers, clinician-investigators, and scientists—to provide ongoing input on priorities, study design, feasibility, and participant burden. Engagement of people with lived experience and treating clinicians should be built into major initiatives, including cohort and biobank design and clinical trials, through advisory roles and explicit engagement requirements in funding announcements. Regular public updates on progress against the implementation plan will further strengthen trust and facilitate recruitment and retention.

* * *

Taken together, these recommendations are intended to help NIH translate the ME/CFS Research Roadmap and the Senate’s directive into a focused implementation plan that can guide the next decade of research. With strategic investments in core infrastructure, a dedicated clinical trials program integrated with post-acute infection platforms, a strong emphasis on clinically meaningful biomarkers and diagnostic tools, and structured engagement of patients and clinicians, NIH can meaningfully accelerate the path toward effective treatments for ME/CFS.

We appreciate your leadership and the work of NIH staff who have supported the Roadmap’s development and early implementation. We would welcome the opportunity to meet with you and your colleagues to discuss these recommendations in more detail and to collaborate on a plan that fully realizes the promise of the ME/CFS Research Roadmap.

Sincerely,

Elizabeth Ansell
Founder and Executive Director
#NotJustFatigue

cc.

The Honorable Robert F. Kennedy, Jr.
Secretary
U.S. Department of Health and Human Services