Dear NIH leaders,

We have no time to waste in the quest for Long COVID treatments.

As you know, the WHO and NICE guidelines guidelines explicitly say forms of cognitive behavioral therapy and exercise are not treatments for post-viral illness.

Why is the RECOVER Initiative prioritizing these debunked, damaging interventions for clinical trials, when we have long lists of potentially effective therapeutics?

In concert with many community voices, we urge you to:

- Halt the planned trials that test exercise and forms of cognitive behavioral therapy (CBT) as treatments for Long COVID;

- Use the funds for trials of therapeutics prioritized by post-viral experts and patient groups in the Long COVID, ME/CFS, and dysautonomia communities [1]

- Dedicate significant and strategic funding for Long COVID research in the just-passed $1.7 trillion omnibus appropriation that provided over $47 billion for NIH

- Establish an ongoing Office of Complex Chronic Conditions in the NIH Office of the Director, to coordinate and oversee research on Long COVID and associated diseases (LCAD) with a commitment to transparency and meaningful involvement of people with LCAD.

Here's why we feel so strongly:

Approximately half of people with Long COVID meet the diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) [2-4]. Research studies and patient reports have shown that exercise therapies often cause harm for people with ME/CFS and cognitive behavioral therapy (CBT) is not an effective treatment [5-8]. In addition, many people with dysautonomia conditions frequently seen in Long COVID, including POTS, have been told their symptoms stem from anxiety and can be treated by CBT, delaying or even preventing diagnosis and treatment.

Given this, it is neglectful that RECOVER would choose to focus on exercise and forms of CBT when there are dozens of drugs available waiting to be trialed that could lead to better outcomes and/or more clues as to the pathophysiology of Long COVID. It is a waste of taxpayer money, limited resources, and crucial time to be testing harmful, debunked hypotheses.

The RECOVER Initiative has the opportunity to make a significant impact on the millions of lives of people with Long COVID and associated conditions. I join the many patients, providers, and researchers demanding that you stop any forward progress on trialing these practices and to invest this valuable funding into therapeutics that have the opportunity to make a real positive impact on patient outcomes.

Whether we have been a part of the RECOVER Initiative as patient representatives, participated in RECOVER as trial enrollees, or watched from the outside as people with LCAD, our loved ones, and members of our communities, we are united in our urging: NIH MUST ensure the RECOVER Initiative nix these trials and fix significant, pervasive problems in leadership, transparency and accountability that has brought us to this troubling point.

As we saw in the HIV/AIDS crisis, NIH can contribute to huge gains in research through a coordinated approach that ensures strategic collaboration across institutes. We need to have top leadership at NIH commit to high level coordination of LCAD research, overseen by the Office of the Director, to ensure that these trials do not move forward, and that appropriate resources are secured and marshaled for a strategic all-NIH effort.

We ask for your assurances that these trials will not move forward, and that you will work with our communities to finally rectify longstanding issues with the RECOVER Initiative.

REFERENCES:

[1] As an example, see the US ME/CFS Clinician Coalition’s ME/CFS Treatment Recommendations: https://drive.google.com/file/d/1T6psBJehr-6BuSNlCGfT6SKNbIFx0Lf5/view

[2] Donna M. Mancini, Danielle L. Brunjes, Anuradha Lala, Maria Giovanna Trivieri, Johanna P. Contreras, Benjamin H. Natelson, Use of Cardiopulmonary Stress Testing for Patients With Unexplained Dyspnea Post–Coronavirus Disease, JACC: Heart Failure, Volume 9, Issue 12,
2021, Pages 927-937, ISSN 2213-1779, https://doi.org/10.1016/j.jchf.2021.10.002.

[3] Jason, L.A.; Dorri, J.A. ME/CFS and Post-Exertional Malaise among Patients with Long COVID. Neurol. Int. 2023, 15, 1-11. https://doi.org/10.3390/neurolint15010001

[4] Kedor, C., Freitag, H., Meyer-Arndt, L. et al. A prospective observational study of post-COVID-19 chronic fatigue syndrome following the first pandemic wave in Germany and biomarkers associated with symptom severity. Nat Commun 13, 5104 (2022). https://doi.org/10.1038/s41467-022-32507-6

[5] ME-Action, GET And CBT Are Not Safe For ME – Summary Of Survey Results, 2019
https://www.meaction.net/2019/04/03/get-and-cbt-are-not-safe-for-me-summary-of-survey-results/

[6] Twisk, FN, Maes, M., A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME) / chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009;30(3):284-99. PMID: 19855350.

[7] Vink M, Vink-Niese A. Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review. Health Psychol Open. 2019 May 2;6(1):2055102919840614. doi: 10.1177/2055102919840614. PMID: 31080632; PMCID: PMC6498783.

[8] NICE Guidelines. https://www.nice.org.uk/guidance/ng206/chapter/Recommendations#managing-mecfs

[9] Rachel Cohrs, STAT DC Diagnosis,
https://www.statnews.com/2022/12/22/after-nine-months-an-update-on-nihs-long-covid-research/

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S. Tharakan
Deborah Thelen
Teresa Theophano
Ashley Thomas
Dwayne Thomas
N Thomas
Caitlynn Thompson
Lidia Thompson
Mack Thompson
Rebekah Thompson
Ariana Thompson-Lastad
Kevin Thonhofer
Chantel Thurman
Westanna Tidwell
Jeanne Tiehen
Noel Tieszen
Rebecca Tiffany
Joe Tilley
Nate Tilton
Carrie Tilton-Jones
Alan Tipping
Patricia Tobin
Bernadetto Tomiaino-Barrett
Kelly Tomins
Melissa Topacio Long
Charles Toporek
Destiny Toro
Lupe Torre
Shawn Towey
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Christine Trant
Alex Trebino
Peter Trewhitt
Tia Triplett
Marina Tsaplina
Glenn Tucker
Rhys Tucker
Michelle Turnbull
Kathleen Turturice
Jay Tyler
Eliana Uku
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Mathieu Vadon
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Richard Vallee
Caroline Van Rijckeghem
Jill Van Sickle
Robert Van Ysendyck
Christina Vargas
Katrina Veerman
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Kristin Verdugo
Audrey Vernick
Navneet Virk
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Marilyn Wacks
Esther Wagner
Casey Wait
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ANNE E Wallick-Bauhof
Nicole Walton
Andrew Wang
Claire Wang
Kieran Warden
Elizabeth Wareham
Jessica Warner
David Watson
Ron Watson
Amaya Watters
Malachi Watts
Rebecca Weger
Lisa Wegman
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Corina Weidinger
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Jared Weiss
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John Whitley
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Dallas Windham
Emily Winson
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Joyce Witt
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Tracy Wolfenden
Fred Wolkovitz
Sharon Wong
aerik woodams
Lia Woodward
Brad Wright
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