USA: National Institutes of Health (NIH) intramural ME/CFS study

[Binkie4]

@B_V

Firstly, Thanks again for the detail you have produced re this study, tests etc. It gives more understanding of how this type of research is conducted, what tests are needed etc and the global nature of the whole process. In 1986, I had a spinal tap about 4 months into the viral infection which I think is at the root of my illness. I was not given specific results and the infection began to clear; no doubt the results have disappeared but I will check.

Secondly, In considering why there has been so little follow up by patients prepared to participate, is it possible that there exists a groundswell amongst patients not to get involved because there is concern about Dr Wallit's previously expressed views, whether justified or not?

http://me-pedia.org/wiki/Brian_Walitt#Controversy

When I read further down this page, there was reference to a 2016 article which led on to a discussion on Cort's ' Health Rising'. There were many pages of comments by responders who wanted nothing to do with the project because of their perceptions of Dr Walitt. ( I am trying to be careful how I express this - the emphasis is on perceptions: bold not working).

https://thoughtsaboutme.com/2016/02...e-perception-mecfs-as-normal-life-experience/

Again there are many, many adverse comments on working with Dr Walitt.
I have not investigated the narratives of illness that he was said to describe but perceptions of his work may surely affect whether patients wish to be involved.
For patients already involved like yourself, I imagine there is real worry about the recruitment of patients. You have already given a lot emotionally and physically. Is there a time limit on the collection of samples for comparison purposes? What happens if more patients are not recruited pretty quickly?

As others have said, this research asks a lot. Honestly, after an experience of severe deterioration following an exercise test, I would not wish to engage with so much exercise. Not that I am eligible: ill for far too long.

Just wondering actually, when a research trial is planned, how much attention is given to how feasible it is in terms of demands on patients?

There's a fair bit to cover there but thank you for engaging with the forum. I would be interested to hear your views.

 

[B_V]

Secondly, In considering why there has been so little follow up by patients prepared to participate, is it possible that there exists a groundswell amongst patients not to get involved because there is concern about Dr Wallit's previously expressed views, whether justified or not?

It seems unlikely someone would express a strong negative opinion on the internet, then call into NIH to express interest in volunteering, make it through a screening interview, and then decide not to participate based on previously stated strong negative opinion. Plenty of people have contacted the NIH team expressing interest. It's somewhere between 200 and 300. The problem lies after people make it through the initial screening and are re-contacted by the NIH team with news that they may eligible to participate. That's where the very high attrition rate takes place. If just 10% or so of the people who are re-contacted joined the study, the study would be full. It only needs another 20-25 patients.

That said, Angelique told me she has gotten a bump in the number of calls and emails from patients expressing interest lately, so thank you Tom Kindlon and anyone else who has helped spread word. It's working.

 

[Binkie4]

@B_V

I am not suggesting that someone who felt strongly enough to criticise the study online would then express an interest in volunteering, then decide not to participate.

I do believe that someone who expressed an interest might then investigate further and perhaps not like what they see. There were many criticisms in the US of the study's design and protocol. That might explain the attrition rate between expression of interest and not continuing.

https://www.meadvocacy.org/nih_sidesteps_critical_problems_with_the_me_cfs_study

I do remember concerns about the NIH study from a couple of years back and have seen that many members of the US ME community were very critical of it. In fact they called it #Paceonspeed if I remember correctly. Well as a UK pwme, when we are trying so hard to get rid of Pace and beginning to turn the tide, that concerns me.

A big worry of mine is the amount of exercise required to participate. I think the study itself acknowledges that it is not suitable for severe patients. But if they are only investigating people with mild/ moderate ME, will the uninformed generalise it to all patients with ME. Advocates have expressed other worries. See link above.

I have attached the link with further comments on the study. I think @Keela Too commented but I think she is not online at the moment.

Glad that you are here to bring notice of this study to the UK. If it is #Paceonspeed, then we need to know.

EDIT: link moved

 

[MErmaid]

@B_V

I am not suggesting that someone who felt strongly enough to criticise the study online would then express an interest in volunteering, then decide not to participate.

I do believe that someone who expressed an interest might then investigate further and perhaps not like what they see. There were many criticisms in the US of the study's design and protocol. That might explain the attrition rate between expression of interest and not continuing.

https://www.meadvocacy.org/nih_sidesteps_critical_problems_with_the_me_cfs_study

I do remember concerns about the NIH study from a couple of years back and have seen that many members of the US ME community were very critical of it. In fact they called it #Paceonspeed if I remember correctly. Well as a UK pwme, when we are trying so hard to get rid of Pace and beginning to turn the tide, that concerns me.

A big worry of mine is the amount of exercise required to participate. I think the study itself acknowledges that it is not suitable for severe patients. But if they are only investigating people with mild/ moderate ME, will the uninformed generalise it to all patients with ME. Advocates have expressed other worries. See link below.

I have attached the link with further comments on the study. I think @Keela Too commented but I think she is not online at the moment.

Glad that you are here to bring notice of this study to the UK. If it is #Paceonspeed, then we need to know.

EDIT: link moved

The ME community does not have a shortage of critics! But we do have a shortage of ME advocates who are public figures, and despite being ill, do their best to make positive changes!

I feel your posts are seeming more “off topic” to me, and deserve their own thread.

 

[B_V]

If it is #Paceonspeed, then we need to know.

PACE was a trial of talk therapy and exercise.

The intramural NIH study is a deep biological investigation.

What's the comparison? Some people like to throw bombs with dumb hashtags and are still living in 1986. They also haven't spent time at NIH in the study. So, yes, a small faction of patients tried to derail the NIH study. Instead they're getting a deep biological investigation of PEM that was designed with input from patients. That's the last I'll say because I'm not interested in engaging with such a negative crowd in rehashing a debate that happened two years ago.

 

[Trish]

That's the last I'll say because I'm not interested in engaging with such a negative crowd in rehashing a debate that happened two years ago.

Thank you for your patience, B_V. I think the study looks excellent and very exciting. It makes sense that a study involving extensive testing including exercise tests can't involve the severely affected.

Any findings that lead to useful blood or other tests can then potentially be tested to see whether they apply to people with longer duration illness and the severely affected.

It does seem a pity that people are rehashing old worries which have been effectively shown to be incorrect. I hope this doesn't put people off applying to take part.

 

[Binkie4]

@B_V

Please don't shoot the messenger.
I'm only reminding you of what is out there. I am not writing about 1986 but 2015.
"Negative crowd?"( BV) I am alone in bringing this to your notice as a response to the question you posed.

 

[Ron]

@Binkie4
If you have any legitimate questions you can email Dr. Nath at: avindra.nath@nih.gov
I initially had questions that he graciously answered and in so doing availed any concerns I had about the study
and convinced me of his dedication to helping find us some answers. Were fortunate to have him heading this study up in my opinion.

Edit to add a thanks to those taking part in this study.

 

[Binkie4]

@Trish

"It does seem a pity that people are rehashing old worries which have beeneffectively shown to be incorrect"

(Apologies for not being in yellow)



Please do you have a link?

 

[duncan]

I am puzzled by why pwME who may have legitimate questions or even misgivings should be discouraged from expressing those. This is a forum, after all.

What if anyone individual espousing support for - and even participating in - an endeavor is wrong?

If he/she is right, good.

The discussion is part of the journey.

 

[Binkie4]

Great expression " the discussion is part of the journey". I thought that is what this forum is about. Thanks @duncan .

 

[duncan]

Thank you for your patience, B_V. I think the study looks excellent and very exciting

I think the study has some exciting elements, and other that might be interpreted as downright counter-intuitive, if not unnerving.

It does seem a pity that people are rehashing old worries which have been effectively shown to be incorrect.

I have no reason to believe this observation is inclusively accurate, as much as I respect and admire @Trish.

I hope this doesn't put people off applying to take part.

Hopefully, just more informed. As advocates, I would think we should all agree on being more informed is better than less.

 

[B_V]

I am puzzled by why pwME who may have legitimate questions or even misgivings should be discouraged from expressing those. This is a forum, after all.

In 2015 and 2016, the group ME Advocacy expressed their misgivings by making a concerted effort to stop the NIH study before it began. They circulated a petition calling for its end and took other actions. Vicky Whittemore, who has nothing to do with the intramural study, took the brunt of a lot of the negativity. (She is involved exclusively with the extramural ME/CFS funding and the inter-institute ME/CFS working group and she is a very important ally for patients inside NIH.) The ME Advocacy people compared the study to PACE, which displays a distinct lack of critical thinking skills. They also spread misinformation on twitter and Phoenix Rising, claiming the study was about non-specific fatigue using Fukuda criteria. This effort was an extremely poor display of the worst side of the ME community. Fortunately, their misguided and poorly-informed attempts were unsuccessful and an important study is underway.

The NIH has made some missteps with the study, most of them in the realm of communications. But they've learned a lot and they explicitly involved patients in the design of the study (which is good). If people want to be suspicious of the brick walls of NIH because of the ugly history of neglect, then they are free to do so. If they decide to focus their anger on Brian Walitt for things he's said, then they are free to do that. But if people aren't willing to fully inform themselves by looking at the study protocol and the other information that is out there, then they should probably try to learn a little more.

I'd also encourage anyone who has had correspondence with Nath or Walitt to post those messages so everyone can benefit from the exchanges.

 

[duncan]

This is one history, certainly.

I am worried about its telling, not to mention bemused and unsure of its implications when taken in context with the early release of disease characterization.

The functional disorder control was only one issue.

Revisionist history can be a dicey thing.

After all these years, maybe we need to be careful.

 

[duncan]

I've heard NIH tales that aren't as sweet, although they are not directly related to ME/CFS.

Having said that, there are some tests I would embrace, some I would not, and if capable, some researchers I would decline, some I would prefer.

But I am only a patient who is unsure and who has questions.

 

[Trish]

"It does seem a pity that people are rehashing old worries which have been effectively shown to be incorrect''
Please do you have a link?

i think @B_V has effectively answered this, as well as Nath and others.

I don't have any insider knowledge other than what I have read and heard on forums. I agree there was understandable disquiet in the past from many pwme because of Wallitt's involvement, but I believe @B_V's account of his experience of taking part in the study.

With so many biomedical tests being done so thoroughly by so many top researchers, I can't see how the study can possibly be compared with PACE in any way. I would hate misinformation to put off possible participants.

 

[WillowJ]

Yes, it's a shame there can't be a <5yrs group and a >5yrs group. The illness looks so different over time, and I think that's one (of many) reason(s) we're having trouble with the diagnostic criteria. It would be so interesting to compare the data from oldies and newbies.

Maybe they can do a group of longer patients later? If things are that much different, possibly treatments could be quite different.

I guess they didn’t want to pack everything into this one study to publish faster (or not so slowly anyway)?

 

[WillowJ]

There are about 40 sub-studies. Avi Nath does have a hypothesis about immune dysfunction that he is testing, but many other avenues are being explored. The investigators have authority from Dr. Collins to do pretty much anything they want to do and they've recruited help from many different NIH institutes. I've been impressed watching the study evolve and seeing the key people learn as they go.

That’s fascinating and encouraging, and thank you for sharing your reassuring thoughts.

I can’t apply as 1) sick too long 2) too ill to travel 3) too ill to recover from exercise test and 4) even too ill to have so much interaction over several days, but it does sound very hopeful that the results will be interesting.

 

[Sunshine3]

I have emailed Dr. Nath and Brian Wallitt and both replied to my questions and were helpful. Dr. Nath didn't answer my most recent question about what the exact numbers are now in phase 2 but Brian has answered that here. I so wish the study wasn't so slow....my fear is not living to see the benefits but I have no doubt that they will uncover so much important info and answers. I think Dr.Nath is very approachable, down to earth and genuine.
As for the NIH, they are not investing enough in ME by a long shot. I am a severe patient myself but not entirely bed ridden. A sense of urgency is desperately needed but it ain't coming from the NIH as we all know. So I have no rose tinted specs on as my life is on the line.

 

[B_V]

Shouldn't it be PEM, that unique and distinguishing symptom which is NOT malaise, but a dramatic and debilitating worsening of symptoms, either individually or collectively, following exertion, that can last from hours to days to weeks?

The entire second visit (which I completed last week) is dedicated to studying PEM. A week of pre-tests, an exercise challenge, and then a week of timed repeat tests. The design was put in place after NIH listened to a patient PEM focus group. At set points after the exercise test, a researcher asked if I felt the exercise had exacerbated any physical, cognitive, or emotional symptoms. She gently nudged me to try to separate effects of being in the hospital (travel lag, bad sleep) from the effects of exercise. Blood was drawn at 1 hour, 4 hours, 24, 48, and 72 hours after exercise, and spinal fluid taken at 48 hours. I also did pre- and post-exercise cognitive tests, fMRI, EEG, and other tests. All of this to characterize PEM and map the shape of it over time. It's a really smart design and the patients who contributed to the focus groups should be thanked.