NIH Request For Information: Soliciting Input on How Best to Advance ME/CFS research

Andy

Andy

Retired committee member
Information Requested

NIH is soliciting input from all interested stakeholders, including researchers, health care providers, individuals with ME/CFS, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, as well as other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole.

Optional: Please indicate if you are a researcher, health care provider, individual with ME/CFS, patient advocate, or other interested party. If you are submitting a response on behalf of an organization or membership as a whole, please indicate the name of your organization.
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https://grants.nih.gov/grants/guide/notice-files/NOT-NS-19-045.html

Hopefully we will be able to submit something on behalf of the forum?
 
Interesting. I suppose that if we are to submit an S4ME response, we should first discuss the main points we want to emphasize. For me personally, for example, that would be:

1) RFA's or other research funds dedicated specifically to ME/CFS to attract researchers into the field.

2) The use of stricter diagnostic criteria that require the presence of post-exertional malaise.

3) More replication, more comparisons with related conditions instead of healthy controls.

4) Training of ME/CFS specialists, because the old ones are reaching retirement ages and we need them to make reliable diagnoses in research.

5) etc.


We should probably try to emphasize points that will not be made by other interest groups (such as a warning against the use of the Chalder Fatigue Scale for example) and will be overlooked unless we make the case.
 
I think ensuring points are covered is very important.

I also think there is value in NIH hearing the important points in several submissions as it shows support for those points among the community.

Possible point to consider - not dwelling on warnings. Readers may end up looking into why the warning but their bias may lead them to the wrong position.

I suggest instead focusing on suggestions surrounding biomedical research that will actually produce meaningful results. (In other words - point them in the direction we want them to go - don't point them to the wrong stuff.)
 
Michiel Tack said:
4) Training of ME/CFS specialists, because the old ones are reaching retirement ages and we need them to make reliable diagnoses in research.
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Ensure that training means people are properly informed of the reasons for patient concern about PACE/CBT/GET/etc so that there isn't a continuation of old prejudices about patients' views.
 
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Michiel Tack said:
2) The use of stricter diagnostic criteria that require the presence of post-exertional malaise.
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This, this and this again. I'm not wedded to a particular set of diagnostic criteria but the presence of PEM is an absolute must.

Only thing I'd add is try and make it a requirement for funding that sub-group analyses are specified openly before data collection.
 
Forgive me if this isn't part of the NIH's remit (I'm from the UK), but are there training/development opportunities here too?

For instance, funding organisations often seem to spread their hands and say they'd like to receive more high-quality applications for research money, suggesting there's a gap there...are there ideas about how to bridge this?

We also need to know much more about how many people get ME. Could the NIH develop a surveillance/reporting programme of some kind?

Also, is there/should there be a US biobank?
 
Kitty said:
For instance, funding organisations often seem to spread their hands and say they'd like to receive more high-quality applications for research money, suggesting there's a gap there...are there ideas about how to bridge this?
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Valid point, the answer obviously is money. In the US, Solve ME/CFS Initiative have a seed grant program to try to relieve this issue.

Kitty said:
We also need to know much more about how many people get ME. Could the NIH develop a surveillance/reporting programme of some kind?
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As I understand it that would be more CDC's area, and some progress was made in this kind of area, https://www.meaction.net/2018/05/26/u-s-votes-to-track-me-cfs-on-brfss-survey/

Kitty said:
Also, is there/should there be a US biobank?
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Solve ME/CFS have a dormant one that they are re-focusing efforts back onto, along with a patient registry. NIH also provides funding to the UK ME/CFS Biobank, them funding one in the US would be good, in my opinion.
 
Simone said:
NIH did a similar process back in 2016. I wrote a bit of a summary of some of the submissions from that process at the time:
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This is very useful, thank you Simone. I think the most important issues are in there.

It is difficult to start working on a document though, without knowing which subjects there is agreement on. Would be helpful if others could list some prorities as well, so we can see which ones have the most support.
 
Is the NIH's current position in relation to funding of trials for ME/CFS going to change anytime soon? There is no mechanism in place for us at present.

The use of stricter diagnostic criteria, the presence of PEM is an absolute must.

@Michiel Tack are you compiling a document or is there someone taking it on? I hope S4ME can make a submission so patient voices can be heard.
 
I have worked out the four proposals I listed in an earlier post. These are the suggestions that came up to me. I hope it will only be a starting point and that others add proposals to it.

Hope that somebody will also fact check what I wrote. I focus mostly on the bad, BPS-research and am not an expert in the decent research that is going on or ways to improve it. Many on this forum know much more about this than me.

I hope that S4ME will be submitting the proposals. That means that there has to be a consensus. So any proposal has to be broadly accepted. And anyone disagreeing with what I've written should speak up, so that controversial claims can be removed before it comes to a vote.
 
1) RFA’s to break the cycle of inertia
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) has an estimated prevalence of 0,2% [1] to 0,4% [2], meaning it is more common than multiple sclerosis, AIDS or systemic lupus erythematosus. Patients with ME/CFS have been found to be more functionally impaired than those with other disabling illnesses, including congestive heart failure and end-stage renal disease. [3] The economic impact of ME/CFS in the US is estimated to be 18-24 billion dollars a year. [4]

Based on the estimated disease burden, equitable research funding for ME/CFS by the National Institutes of Health (NIH) would amount to 188 dollars million per year. [5] This is more than fifteen times the amount the NIH currently spends. [6] An enormous disparity exists between the research funding that is required and what is currently being done.

One of the main reasons for this is a lack of grant applications. Researchers are hesitant to jeopardize their career by entering a field where funding is uncertain. Research proposals in the field of ME/CFS could also be scarce due to the fear of being rejected on irrational grounds. Even internationally respected scientists such as Ronald Davis [8] and Ian Lipkin [9] have been rejected or ignored when they applied for research into ME/CFS. ME/CFS is a relatively new disease that suffers from stigma and prejudices, even within the research community and medical profession.

The result is a cycle of inertia where researchers are unwilling to enter the field as long as it remains underdeveloped. We believe the most efficient method to break this cycle is by earmarking funds for ME/CFS. By issuing requests for applications (RFA’s) the NIH could attract new researchers to study ME/CFS. This would reduce the disparity between the societal burden of ME/CFS and the dire lack of funding devoted to this illness. The use of RFA’s has been successful in the past in ME/CFS [9] and the development of other fields [10].

We, therefore, recommend the NIH to increase the number of RFA’s to further research into ME/CFS.

References

[1] Reyes M, Nisenbaum R, Hoaglin DC, Unger ER, Emmons C, Randall B, et al. Prevalence and incidence of chronic fatigue syndrome in Wichita, Kansas. Arch Intern Med. 2003 Jul 14;163(13):1530-6.

[2] Jason LA, Richman JA, Rademaker AW, Jordan KM, Plioplys AV, Taylor RR, et al. A communitybased study of chronic fatigue syndrome. Arch Intern Med. 1999 Oct 11;159(18):2129-37.

[3] Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington, D.C.: The National Academies Press, 2015.

[4] Jason LA, Benton MC, Valentine L, Johnson A, Torres-Harding S. The economic impact of ME/CFS: individual and societal costs. Dyn Med. 2008 Apr 8;7:6.

[5] Dimmock ME, Mirin AA, Jason LA. Estimating the disease burden of ME/CFS in the United States and its relation to research funding. J Med Therap, 2016;1(1):1-7.

[6] Spotila J. (2018, October 21). NIH Funding for ME Goes Down in 2018. occupyme.net. Available at: https://occupyme.net/2018/10/21/nih-funding-for-me-goes-down-in-2018/

[7] MEAction. (2015, 20 August). Ron Davis on why his NIH proposal was rejected. https://www.meaction.net/2015/08/20/ron-davis-nih-proposal/

[8] Interview with Dr. W. Ian Lipkin, ME/CFS Alert Episode 95. (December 2, 2017).

[9] Neuroimmune Mechanisms and Chronic Fatigue Syndrome. RFA-OD-06-002. https://grants.nih.gov/grants/guide/rfa-files/rfa-od-06-002.html

[10] Limited Competition of the MAPP Research Network (U01). RFA-DK-13-507. https://grants.nih.gov/grants/guide/rfa-files/RFA-DK-13-507.html
 
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