2024: USA NIH NINDS ME/CFS Research Roadmap - input on research priorities sought by 11 March 2024

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News from NIH: NINDS is seeking feedback on ME/CFS Research Roadmap Priorities

NINDS is seeking your input on the ME/CFS Research Roadmap priorities. The goal is to collect broad feedback from the public on the research priorities being developed by the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research Roadmap Working Group of Council that will result in a report presented to the National Advisory Neurological Disorders and Stroke (NANDS) Council in May 2024.


The public comment period is now open and is scheduled to close on March 8, 2024. We encourage stakeholders to review all of the priorities and comment on as few or as many as each individual or organization prefers.


Comments may include input on how the draft research priorities could be enhanced, new research questions that could be included, or challenges that the current research priorities may face.


Comments will be public so please do not include any personal and/or medical information.


To submit feedback, visit the IdeaScale website

To learn how to use the IdeaScale website, watch this instructional video


To learn more about the ME/CFS Research Roadmap and to view the research webinars, visit: https://www.ninds.nih.gov/about-nin...l/nandsc-mecfs-research-roadmap-working-group

If you have any questions regarding the Research Roadmap process or IdeaScale, email MECFSResearchRoadmap@ninds.nih.gov

 

In case it is of use, I have recorded my progress through this so far. I think that many pwME will be excluded due to relative complexity of the platform.


To submit comments, or "ideas" as the site calls them, you will need to create an account.

Create an account.

Click on Log in (top right of screen) from https://ninds.ideascalegov.com/c/campaigns/1286/about or any of the priority group pages.

Click on the first, grey, button, titled "Google, Microsoft, Paypal, Login.Gov, Government, or Institutional Account" if you will use these options to sign in.
- On the next screen and select your preferred login option

Click on the second, blue, button to create an Ideascale account if you do not have access to any of the options listed immediately above.
- Choose the "Sign-up" option.
- Enter the requested detail.
- Click on the link in the verification email sent to your email address, and enter the verification code from the email.
- You will then need to click on Log-in again, in order to log-in with your new account (or at least I did).
- When you do, you will then be prompted to enter First Name, Last Name and User Name. This screen also displays a Display Name, which is automatically generated from your email and cannot be changed, but given that User Name is described as "a unique username that is used in collaborative features, such as @mentions." I assume that Display Name won't be seen by others, despite its name.
- You will need to agree to the Terms of Service (in short, don't be nasty, or an idiot in any other way) on EVERY page (hub page, and priority group pages).

Submitting ideas.

You are not able to submit ideas on the 'hub' page, https://ninds.ideascalegov.com/c/campaigns/1286/about. You need to submit them on the separate pages for specific priority group - links available from the hub page or a drop down menu in the top left of the screen.

For each idea submitted, you will need to complete
- Idea Title
- Idea Description
- Answer, "Do you agree with the research priorities as outlined for research on the [particular priority group - e.g immune system] involvement in ME/CFS?"
- Do you have specific comments/feedback on any of the research priorities?
- Do you have additional research priorities for research on the [particular priority group - e.g immune system] involvement in ME/CFS?

Optionally, you can also
- add a Tag, i.e. sleep, fatigue, etc
- Attach an image or supporting document
- Submit your idea anonymously. However they say "Ideas submitted anonymously are excluded from leaderboard points. Submitters cannot change their anonymous setting to make their name publicly visible after an idea has been submitted. Administrators do have access to anonymous submitter information in the software."

 

NINDS is seeking feedback on ME/CFS Research Roadmap Priorities-- new email option


NIH MECFS Information List <NIHMECFSInformationList@mail.nih.gov>

to NIH-MECFS_INFORMATION

We are writing to offer an email option to provide input and feedback on the ME/CFS Research Roadmap research priorities that are currently posted on IdeaScale. We recognize that IdeaScale can be challenging to navigate, so please provide comments on any of the research priorities to: mecfsresearchroadmap@ninds.nih.gov

When you submit your feedback and comments via email, please also let us know the following:

1. Would like us to post your feedback/comments on IdeaScale for you? Answer: Yes/No
2. Would like us to post your feedback/comments anonymously or with your name? Answer: Anonymously/With my name: please provide your full name

Please send any questions about this process to the email address provided: mecfsresearchroadmap@ninds.nih.gov


To learn more about the ME/CFS Research Roadmap and to view the research webinars, visit: https://www.ninds.nih.gov/about-nin...l/nandsc-mecfs-research-roadmap-working-group

 

---------- Forwarded message ---------
From: NIH MECFS Information List
Subject: NINDS is seeking feedback on ME/CFS Research Roadmap Priorities-- Updated information




NINDS is seeking your input on the ME/CFS Research Roadmap priorities. The goal is to collect broad feedback from the public on the research priorities being developed by the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Research Roadmap Working Group of Council that will result in a report presented to the National Advisory Neurological Disorders and Stroke (NANDS) Council in May 2024.


The research priorities from all 8 webinars are now published on IdeaScale and are attached to this email.


The public comment period is now open and is scheduled to close on March 8, 2024. We encourage stakeholders to review all of the priorities and comment on as few or as many as each individual or organization prefers.


Comments may include input on how the draft research priorities could be enhanced, new research questions that could be included, or challenges that the current research priorities may face.


Comments will be public so please do not include any personal and/or medical information.


To submit feedback, visit the IdeaScale website

To learn how to use the IdeaScale website, watch this instructional video


Individuals may also provide feedback on the research priorities by sending an email to: MECFSResearchRoadmap@ninds.nih.gov and NINDS staff will post your comment to IdeaScale. When you send your ideas/comments, please indicate which topic area your comment pertains to (Nervous System, Immune System, etc.) and whether or not you would like your comment to be posted with your name or anonymously. The list of research priorities for all 8 topic areas is attached.


To learn more about the ME/CFS Research Roadmap and to view the research webinars, visit:https://www.ninds.nih.gov/about-nin...l/nandsc-mecfs-research-roadmap-working-group


If you have any questions regarding the Research Roadmap process or IdeaScale, email MECFSResearchRoadmap@ninds.nih.gov

 

It seems like this isn't receiving much attention from patients. Maybe because o the registration process. Most of the ideas posted so far seem to be not very good.

Go here to vote and submit ideas https://ninds.ideascalegov.com/c/campaigns/1286/stage/all/ideas/unspecified

 

Just added my contribution:

 

New, 11-minute video by Dr Jarred Younger who talks about the National Institutes of Health ME/CFS Roadmap which is seeking comments/ideas till March 8. He encourages people including non-scientists to make submissions

https://www.youtube.com/watch?v=VQxir5qb-40

 

Has anyone submitted something to be posted on the website by email? Did you get a confirmation email back? And how long did it take for your post to go up?

I sent a couple of ideas and am wondering if they ended up in spam and whether to chase it up or wait.

 

Last week to make submissions (the email route works by the way, if you can't face the rigmarole of the website)

https://solvecfs.org/solve-responds...al-me-cfs-clinical-study-published-in-nature/

 

I haven't, but it's because I see a lot of issues with the approach but am not knowledgeable enough to suggest otherwise. I suspect their working methods are so inflexible that it'd be a waste of my time anyway.

My worries include:

That they're not starting from ME, they're starting from a list of subject categories;

That working in silos might obstruct attempts to get a rounded understanding, or encourage researchers to pick out the bits they think will look best on their CVs rather than the ones they genuinely believe will provide answers;

That they're prioritising a lot of research relying on new technologies and approaches, which seems likely to throw up reams of data that no one has the experience to interpret, or findings that can't be replicated because no one else can afford access to the kit;

That there are some dead horses in there that might not be worth flogging any further—inflammation, chronic infection, deconditioning;

And that people with ME don't really seem to be present, apart from an invitation to provide feedback on priorities that already look set in stone.

 

@Kitty, very valid concerns. In fact, that exactly the sort of feedback they need to hear!

You can choose to give specific feedback on one or more of the separate areas of research they covered in their videos (neuro, immune, etc I forget what they all were, eight in all I think).

Or you can choose to give more general feedback on matters not covered in those topic areas. Skimming comments in that section, there are already a number that relate to problems with the research ecosystem and with how research is being done but plenty of room for additional points to be made.

I think it's important to get these sorts of concerns on record wherever and whenever there's an opportunity. Yes, often this will indeed sink without a trace and thus feel like a waste of time, but you never know when some of it may worm its way into the brains of people who can do something about it. Also, there are some good researchers involved who, I like to think, are pushing for higher quality research behind the scenes (even if only in the sense of being allowed - read: funded - to do higher quality research themselves). Can't do any harm if they can point to strong support from the patient community.

Most of the feedback posted so far is short and to the point, so unless someone has a lot of energy to spare - yeah, right - there's no need to go to great lengths, we can leave the more in-depth stuff to organisations like Solve, but many individuals submitting a brief thoughtful comment or two is still a good idea - if only to drown out some of the commenters just pushing this or that pet idea

 

Thanks, @Ravn, I will. I guess I've already drafted most of the thoughts I had, so it won't take much longer to finish it!

 

Thanks for the heads up about this.

I went to the ideascale website and signed up.

Do you know if it's possible to vote up someone's idea? I couldn't find a button for it anywhere only a little box saying 'net votes hidden'.

 

I couldn't really figure that out either, but you can press the applause button instead, for one idea per day. Not sure how it differs from an upvote.

 

Cross posting from thread USA:NANDSC Working Group for ME/CFS Research report, September 2019. I thought it would be helpful to remind people where the Research Roadmap effort came from.

NIH seems to have taken down the PDF report from the 2019 NANDS meeting. No idea why .....................

Luckily a copy was saved on Wayback Machine / Internet Archive
http://web.archive.org/web/20220112...cil_working_group_for_mecfs_research_508c.pdf

The ME Action link has also disappeared. This was the letter they wrote to NIH after the 2019 report came out
http://web.archive.org/web/20220421...ds/2019/10/NANDS-Report-Response_10-22-19.pdf

All we hear recently is that NIH will report on the Research Roadmap in a few months to the NANDS council. That looks nothing like the task NANDS gave Whittemore and Joeseph Breen in 2019 to put into place a strategic plan for ME/CFS, and absolutely nothing like what ME Action was asking for.

 

I wrote up a draft submission, which I plan to upload tomorrow. I'd appreciate any comments if anyone has any.

Dear NIH,


Thank you for the opportunity to provide feedback on the ME/CFS research priorities. The patient community appreciates the renewed efforts the NIH has placed into ME/CFS and Long COVID research, including through the Intramural Program.


Patient engagement and input into research priorities is also much appreciated. I suggest in future partnering with the Science for ME forum to promote awareness of future consultations. Many of the more scientifically minded patients are members of the S4ME forum. I was not aware of this consultation until this week.


I have reviewed the list of priorities and am impressed by its thoroughness. The NIH should be commended for reaching out to global subject matter experts in developing this prioritisation plan. I apologise if any of my suggestions are already in the priorities list. I am not a scientist so may miss the implications of some of the existing priorities.


I suggest that the NIH use these scientists as peer reviewers in assessing future grant requests (where they have relevant expertise). Anecdotally, the patient community has heard stories of the NIH using peer reviewers who do not believe that ME/CFS is a biophysical illness or lack a understanding of the latest research. This has served to undermine patient confidence in the NIH. Conversely, an improved peer review process could restore hope and confidence to the patient community.


I note the discussion in various groups on identifying a biomarker. The NIH should investigate and validate a biomarker that has already been identified. Ron Davis' nanoneedle research correctly identified all ME/CFS patients and all healthy controls (Esfandyarpour et al, A nanoelectronics blood-based diagnostic biomarker for ME/CFS Proc Natl Acad Sci USA (2019)). This research has been replicated in the UK with ME/CFS patients, healthy controls and MS patients (though the results have not been published). The nanoneedle is designed to be a cheap diagnostic tool and it could be the biomarker that has long been sought.


The biological interpretation of these findings - what exactly it means that ME/CFS cells are stressed - is unclear. One explanation may be the Wirth/Scheibenbogen hypothesis. The NIH should investigate this hypothesis further (Wirth and Scheibenbogen 2020 https://pubmed.ncbi.nlm.nih.gov/32247028/)


Until a biomarker is identified, care has to be taken in ensuring that patient cohorts in trials have ME/CFS and not other fatiguing illnesses. The population indirectness issues with the GET trials, which mainly used outdated definitions of ME/CFS that did not include post-exertional malaise (PEM), are well known. Best practice trials now require patients to have PEM and be diagnosed with ME/CFS. But could a person who self-reports as having PEM be mistaken? The IOM report summarised the research, finding that 4 to 8% of healthy controls self-reported as having PEM (https://www.ncbi.nlm.nih.gov/books/NBK284902/). Thus, population indirectness may remain a (smaller) issue even in patient cohorts diagnosed meeting the ICC or other modern definition of ME/CFS.


The NIH should investigate how trial design could overcome this issue. One way may be to ensure all patients undergo a 2 day CPET to verify their PEM objectively, but this is expensive and selects against more severe patients who cannot undergo a CPET. An alternative is to recruit a larger cohort of patients. The NIH should run 2 day CPETs in a large number of patients to identify the proportion of persons diagnosed with ME/CFS with self-reported PEM who do not have PEM as measured by CPET. The NIH should outline a methodology for calculating how many more patients are required. If e.g. 4% of patients do not have PEM, then how many more patients are required to ensure the trial has sufficient statistical power to overcome a population indirectness problem of this magnitude?


Another question is whether trials should exclude ME/CFS patients with depression and other co-morbidities. Depression is common as a result of ME/CFS and this could skew the studied patient population towards less severe patients. The NIH should investigate whether patients with and without depression differ on various measures.


The NIH should also engage in autopsy studies. Existing autopsy studies have identified persistence of various viruses in deceased ME/CFS patients, particularly the brain (see https://me-pedia.org/wiki/Autopsy_in_Myalgic_Encephalomyelitis for an overview). Dr Chia has repeatedly found enteroviruses in stomach biopsies. Perhaps the NIH could also do autopsies or biopsies on the vagus nerve which has been implicated in ME/CFS as well as tissues, other nerves and the CNS. It appears that viral persistence cannot be identified through blood and urine samples - viruses have been found in the tissues of those whose blood and urine tested negatively (

https://www.youtube.com/watch?v=b9k-sI9P8QI

)


Recent research in long covid showed that there is physical muscle damage after PEM (as identified by muscle biopsies). This study should be replicated in a cohort of ME/CFS patients. (Appelman et al 2023, https://www.nature.com/articles/s41467-023-44432-3).


The NIH should also defund and cease any research into its effort preference hypothesis and remove Dr Wallit from any ME/CFS research. The test identifying "effort preference" in Wallit et al 2024 (https://pubmed.ncbi.nlm.nih.gov/38383456/) was designed to measure anhedonia. It doesn't identify effort preference if patients face negative biophysical consequences for engaging in exertion (such as pressing a button repeatedly). Patient concerns about Dr Wallit are long-standing and predictions that he would attempt to psychologist ME/CFS have now been borne out. The paper would otherwise have been bolstered patient confidence in the NIH given that it replicated findings that show ME/CFS is a biophysical illness.


I note that one of the circulation research priorities includes "facilitat[ing] placebo-controlled clinical trials with repurposed drugs directed at the underlying circulatory pathophysiology, e.g., pyridostigmine, low dose naltrexone". LDN deserves attention as a separate priority given that it is one of the few treatments for ME/CFS. It has a broader application than just ameliorating circulatory pathophysiology. For example, the Griffith Uni research showing it helps with calcium ion channel dysfunction (e.g. Cabanas et al 2021 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8313851/).


On a similar note, the NIH should run a placebo controlled RCT of low dose Abilify (see Crosby et al https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-021-02721-9).


This submission reflects my personal views, but I acknowledge with gratitude the assistance of members of a ME/CFS Telegram social group with idea generation and research.

 

A clear and useful letter. Just a trivial point, typo in above quote, I am assuming ‘psychologist’ should read ‘psychologise’.

 

Don’t think NIH would fund a trial like this.

But could do something like this. Take 10 MECFS patients. Collect “ a bunch” of data t=0; 2 weeks (steady state); 4 weeks, then withdraw; 6 weeks (most of drug out of system); 8 weeks, then end. Dosage say 0.5 mg. People not responding by 4 weeks are unlikely to respond with longer treatment.

 

A little reminder that the deadline for this is tomorrow.