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

[belbyr]

Are there any rumors that there will be any significant findings in the study?

My gut tells me this is the most thorough investigation to date into ME/CFS, surely something will come of it.

edit: I actually just saw a video of Nath saying they replicated the findings of Ian Lipkin in this big study in regards to the biome.

 

[Kalliope]

Tweets from Dakota_150:
To the #pwME community, that has implications for #pwLC & beyond. This is the latest reply from @NIH
on the ME/CFS Intramural Study led by Dr. Nath: 3/24/23: "They plan to submit the paper for review within the next month. There have been many people who needed to review the paper at multiple levels at NIH which is what has taken time. They told me they would let me know when it gets submitted for review. It is hard to know how long that review will take – some journals are taking months to review submitted manuscripts, so we can’t predict how long that process will take." Sharing here as I think it's important for the community to be conscious of.

 

[Hubris]

Posts moved from USA: The RECOVER Initiative

How much do you wanna bet a couple years from now the NIH will be regretfully telling us how they don't have enough money or staff or patients to fast track a replication of Nath's findings in the intramural study on a bigger cohort, and they really wish they could but they can't, after having done nothing useful with almost 2 billion dollars of tax money and 20,000 patients at their disposal?

And of course we will have to listen for years on end from everybody else in the world that the intramural study findings don't matter because it's only a handful of patients and our illness is definitely still psychosomatic and we are not as disabled we say we are.

History always repeats itself, especially when the events are gruesome.

 

[Charles B.]

How much do you wanna bet a couple years from now the NIH will be regretfully telling us how they don't have enough money or staff or patients to fast track a replication of Nath's findings in the intramural study on a bigger cohort, and they really wish they could but they can't, after having done nothing useful with almost 2 billion dollars of tax money and 20,000 patients at their disposal?

And of course we will have to listen for years on end from everybody else in the world that the intramural study findings don't matter because it's only a handful of patients and our illness is definitely still psychosomatic and we are not as disabled we say we are.

History always repeats itself, especially when the events are gruesome.

I can’t fathom why anybody is eagerly anticipating the grand reveal of the intramural study data. The 17 patient cohort will be immediately laughed out of existence by the minimizers and BPS acolytes. We will cite it to our own detriment, and all the while, the FND crowd will continue to empire build. Most ME patients will end up with FND diagnoses while figures like Carson, Stone, Perez, McWhirter, Grin, etc replace Wessely, Sharpe, Reeves, Straus, and the rest of the original ghouls.

 

[belbyr]

I can’t fathom why anybody is eagerly anticipating the grand reveal of the intramural study data. The 17 patient cohort will be immediately laughed out of existence by the minimizers and BPS acolytes. We will cite it to our own detriment, and all the while, the FND crowd will continue to empire build. Most ME patients will end up with FND diagnoses while figures like Carson, Stone, Perez, McWhirter, Grin, etc replace Wessely, Sharpe, Reeves, Straus, and the rest of the original ghouls.

There was only 17 patients?

 

[Charles B.]

There was only 17 patients?

Yes, I believe they ultimately enrolled and assessed 17 patients for the second phase of the study. The first phase was determining whether the individuals had some other condition responsible for their symptoms.

I’m almost certain this is the case. I tuned in to a webinar discussion where Nath detailed certain elements of the study

 

[Andy]

There was only 17 patients?

The full inclusion criteria can be seen here, https://mecfs.ctss.nih.gov/

The combination of, relatively, strict inclusion criteria and what they were asking from the patients in terms of attendance at the testing centre meant that they struggled to recruit participants and then seemed to whinge about the lack of people applying to take part.

"Inpatient ME/CFS group: Those with ME/CFS that started after an episode of infection who have severe symptoms based lasting between 6 months to 5 years, based on the study evaluation"

So think how well someone who is severe will be able to handle the following,

"The first inpatient visit lasts 5-10 days. Tests include:

• An explanation of the study and signing of the research study consent form
• Medical history
• Physical exam and strength testing
• Blood and urine collection
• Saliva, cheek swab and stool sample collection
• Questions about the participant's life and their quality of life
• Questions about the participant's mental health
• Thinking and memory tests
• Magnetic resonance imaging (MRI) of the brain.
• A lumbar puncture (spinal tap)
• Tests of sweating. breathing, blood pressure in different positions, and heart rate
• Questions about the participant’s diet and food preferences
• Collection of a large volume of blood cells
• Sleep test
• Occupational therapy
• Holter monitor
• Consults with Internal Medicine and Muscular Dystrophy

Those who will continue to the exercise stress visit will need to wear an activity monitor and keep a fatigue diary and food records for at least one week at home between visits.

Participants who are on medications that could interfere with the study testing will be asked to stop those medications prior to the exercise stress visit, if it is possible to do so safely.

The second inpatient (exercise stress) visit lasts 10 days. Tests include:

• An exercise stress test. Participants will pedal stationary bike until too tired to continue.
• Interviews about fatigue, symptoms, diet, health, and mood
• Sleeping in a metabolic chamber- a room that monitors energy and nutrient balance.
• Eat a special metabolic diet where all of the food is weighed before being prepared
• Wear a transparent hood to measure energy use
• Saliva, blood, stool, and urine collection
• Thinking and memory tests
• Wearing an activity monitor and completing activity logs
• Brain transcranial magnetic stimulation
• X-rays to look at body composition
• Magnetic resonance imaging (MRI) of the brain.
• Lumbar puncture (spinal tap)
• Have your brain waves measured while you sleep with an electroencephalogram (EEG)
• Optional muscle and skin biopsies"

 

[Sid]

Sounds like a gruelling ordeal. I have mild-to-moderate ME these days and there’s no way I’d be able to handle all that.

 

[Hubris]

I can’t fathom why anybody is eagerly anticipating the grand reveal of the intramural study data.

The idea behind the study is good, the problem is that most people at NIH act in completely bad faith when it comes to ME.

 

[Mij]

Sounds like a gruelling ordeal. I have mild-to-moderate ME these days and there’s no way I’d be able to handle all that.

No kidding. My heart rate went up just from reading this.

 

[ahimsa]

New thread (24 posts) on mastodon from Brian Vastag:

https://sciencemastodon.com/@brianvastag/110272335599929743

You can use the link to read the whole thing (worth it!)

But I've transcribed the first post and the news in posts 17 to 20 for those who have trouble with threads:

Six year ago, I returned to NIH, where I started my career as a science writer, to be a patient in an ambitious study to understand post-infectious myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

The study included 30+ researchers & substudies & was a fishing expedition to understand what goes wrong to make us so sick (like bedbound-for-years sick).

NEWS: The study's findings have FINALLY been submitted for publication.

(the next posts in the thread describe how the study got started and lots of details about patient selection and the data that was collected)

And finally, a few days ago - six years to the week I first entered the study - I got word that the NIH, after extensive internal review, has FINALLY submitted their main paper from the study to a journal for publication. I suspect Avi submitted to New England Journal of Medicine, his go-to journal, but I don't know for sure. It took entirely too long.

And I have no idea what they've found, or how valuable it will be. They threw so many technologies at this illness they must've found something interesting. They used a technology to look at thousands of proteins in spinal fluid, for instance. In the meantime, millions more people have developed ME/CFS after covid - an outcome obvious to all of us who have been suffering post-infectious ME/CFS pre-pandemic.

#LongCovid is, in many cases, ME/CFS. In May 2020, @Bether [Beth Mazur] and I warned that this would happen in pages of the Washington Post. The article was extremely well-read - it was on the homepage for over 24 hours, a rarity - but it also hit the same weekend the George Floyd protests started. If not for the protests, I'm quite certain we would've gotten good TV and radio pick-up (broadcast people look at the top articles on WaPo and NYT and follow those stories).

https://www.washingtonpost.com/heal...d5edb2-a02c-11ea-b5c9-570a91917d8d_story.html

I lament the lost opportunity here. If the study ends up revealing key patho-biology of ME/CFS (please g*d, I hope it does), that information could have informed the studies of #LongCovid now underway. Instead, we now have to wait for a journal to accept the article & publish it.

Edit: If I wasn't already a mastodon user I would join just so I could follow Brian!

Edit #2: The first post in the thread was edited to add a one line summary of the news. So I've added that here as well.

 

[Wilhelmina Jenkins]

I can’t fathom why anybody is eagerly anticipating the grand reveal of the intramural study data. The 17 patient cohort will be immediately laughed out of existence by the minimizers and BPS acolytes. We will cite it to our own detriment, and all the while, the FND crowd will continue to empire build. Most ME patients will end up with FND diagnoses while figures like Carson, Stone, Perez, McWhirter, Grin, etc replace Wessely, Sharpe, Reeves, Straus, and the rest of the original ghouls.

I actually don’t think that this is true. The scientific community knows that intramural studies at NIH are rare and often small, but deep. From the beginning, Nath said that the purpose was to use all of NIH’s tools to see what they could find, then pass it over to extramural researchers to do larger studies on what was found. He has said before that even if they find something significant in just a handful of patients, that would still be meaningful.

The worst case scenario would be not finding anything new or interesting. Nath has indicated that that is not the case. Let’s hope that we agree with him on what deserves a follow-up.

What I hope is that, if there is anything exciting in the paper, the patient community, and maybe some members of Congress, will immediately call for, and push hard for, set-aside funding like the RFAs that funded the 3 research centers. NIH has the money. A new Director should be in place. This could be interesting.

 

[Hubris]

New thread (24 posts) on mastodon from Brian Vastag:

https://sciencemastodon.com/@brianvastag/110272335599929743

You can use the link to read the whole thing (worth it!)

But I've transcribed the first post and the news in posts 17 to 20 for those who have trouble with threads:


(the next posts in the thread describe how the study got started and lots of details about patient selection and the data that was collected)








Edit: If I wasn't already a mastodon user I would join just so I could follow Brian!

Edit #2: The first post in the thread was edited to add a one line summary of the news. So I've added that here as well.

Reading that mastodon thread, I get the impression that the NIH intramural study started out at great speed and with good intentions, and then lost momentum very quickly and started trudging through before coming almost to a halt. This was almost surely due to great friction and i would bet money the BPS brigade had connections at NIH and tried their best to sabotage the whole thing, not to mention the general skepticism most neurologists have about ME being a real illness and deserving any sort of research.

I do think a few people inside NIH believed in this and tried what they could to make it happen, but they have to fight against everyone else, potentially ruining their entire career and It's not easy. Easier than living with severe ME for sure, but still not easy. If you have anything to do with biomedical ME research, everyone is your enemy.

 

[Sid]

Visit two was exhausting. I talked with other patients in the study who were sicker than I was, and they were absolutely annihilated by it. Some took months to recover back to their already-shitty baseline functioning. It was an ordeal, but we were all motivated to help move research forward. 12/

From Brian Vastag’s thread. Very worrisome and yet totally predictable outcome. I remember reading the original protocol and thinking no one with actual severe ME/CFS will be able to endure this.

 

[Binkie4]

Thank you to those severe patients who underwent this gruelling experience. I hope that they have all recovered back to baseline.

 

[Wilhelmina Jenkins]

Reading that mastodon thread, I get the impression that the NIH intramural study started out at great speed and with good intentions, and then lost momentum very quickly and started trudging through before coming almost to a halt. This was almost surely due to great friction and i would bet money the BPS brigade had connections at NIH and tried their best to sabotage the whole thing, not to mention the general skepticism most neurologists have about ME being a real illness and deserving any sort of research.

I do think a few people inside NIH believed in this and tried what they could to make it happen, but they have to fight against everyone else, potentially ruining their entire career and It's not easy. Easier than living with severe ME for sure, but still not easy. If you have anything to do with biomedical ME research, everyone is your enemy.

I’m feeling a bit like a contrarian, but I think that you are underestimating the respect and authority that Dr. Collins carried as Director of NIH. I know that our community was deeply disappointed that he did not do more for our disease, but this project was his baby. Dr. Nath was doing lots of other things before Dr. Collins tapped him for this research. I have no doubt that there are still people in NIH who carry negative impressions about our disease. You could see that clearly a couple of years ago when Vicky Whittemore, someone who has worked steadily on our side, repeated ugly remarks that she had undoubtedly heard through the NIH grapevine. But those are not people with the kind of power to sabotage something that Dr Collins had called for.

My opinion is that the study’s difficulties were caused largely by the lack of stakeholder input from our community from the beginning of the project. The enormous roadblock of selecting Wallit for a key role would not have happened with community input. All indications are that he did a good job under Dr Nath - he would have been a fool not to have - but his prior psychobabble about the nature of ME/CFS raised huge red flags. Time had to be spent reassuring the community rather than going full tilt on the work. And this was difficult since the ME/CFS community has absolutely no reason to trust NIH. They still have not done the kind of patient engagement that would have prevented the Wallit obstacle and other missteps early in the game. These obstacles also affected the speed of recruitment of patients.

So I see the slowdown of the initial excitement as a result of NIH’s incredibly poor history in addressing this disease and constructively engaging the community rather than active sabotage.

Also I have not seen researchers whose careers are being ruined by working on ME/CFS for quite a while. If you look at the people doing research here in the US - all that I can speak about with any knowledge - most of them have robust careers. Most even have some NIH funding. The problem, in my opinion, is not doubt about the biological nature of this disease but a complete lack of urgency in tackling it by our government agencies.

 

[ahimsa]

New thread (24 posts) on mastodon from Brian Vastag:

https://sciencemastodon.com/@brianvastag/110272335599929743

FYI, Brian has added a few more posts to his thread with some more details. Here's where the new posts start:

https://sciencemastodon.com/@brianvastag/110277883131405158

[not up to transcribing posts today]

EDIT: I updated the link. The link I posted earlier is how the post is shown to me on my mastodon server, disabled.social (Fediverse has multiple servers that share posts, even different kinds of software, not just mastodon...).

Anyway, it's better to post the link to the original mastodon server, sciencemastodon.com, so I changed it.

 

[Hubris]

I’m feeling a bit like a contrarian, but I think that you are underestimating the respect and authority that Dr. Collins carried as Director of NIH. I know that our community was deeply disappointed that he did not do more for our disease, but this project was his baby. Dr. Nath was doing lots of other things before Dr. Collins tapped him for this research. I have no doubt that there are still people in NIH who carry negative impressions about our disease. You could see that clearly a couple of years ago when Vicky Whittemore, someone who has worked steadily on our side, repeated ugly remarks that she had undoubtedly heard through the NIH grapevine. But those are not people with the kind of power to sabotage something that Dr Collins had called for.

My opinion is that the study’s difficulties were caused largely by the lack of stakeholder input from our community from the beginning of the project. The enormous roadblock of selecting Wallit for a key role would not have happened with community input. All indications are that he did a good job under Dr Nath - he would have been a fool not to have - but his prior psychobabble about the nature of ME/CFS raised huge red flags. Time had to be spent reassuring the community rather than going full tilt on the work. And this was difficult since the ME/CFS community has absolutely no reason to trust NIH. They still have not done the kind of patient engagement that would have prevented the Wallit obstacle and other missteps early in the game. These obstacles also affected the speed of recruitment of patients.

So I see the slowdown of the initial excitement as a result of NIH’s incredibly poor history in addressing this disease and constructively engaging the community rather than active sabotage.

Also I have not seen researchers whose careers are being ruined by working on ME/CFS for quite a while. If you look at the people doing research here in the US - all that I can speak about with any knowledge - most of them have robust careers. Most even have some NIH funding. The problem, in my opinion, is not doubt about the biological nature of this disease but a complete lack of urgency in tackling it by our government agencies.

Maybe the BPS people did not have direct involvement and there was no direct sabotage, however it is obvious from my point of view that aside from a very small minority, everyone else at NIH has no motivation whatsoever to research ME, and a good majority consider the illness to not be an illness, else you wouldn't see the ugly remarks that you mentioned.
I still consider this sabotage, because of how disabling the illness is and the fact that science is a collaborative effort. Maybe saying that if you research ME everyone is your enemy it is a bit much, but it certainly doesn't earn you any favors. I know researchers that tried to research ME secretly in their lab and not being able to publish because the head of neurology had forbidden them from doing it. And this is not a rare occurrence, it is very common where i live - but i don't live in the US; things are probably more reasonable there from what I've seen.

 

[Solstice]

Maybe the BPS people did not have direct involvement and there was no direct sabotage, however it is obvious from my point of view that aside from a very small minority, everyone else at NIH has no motivation whatsoever to research ME, and a good majority consider the illness to not be an illness, else you wouldn't see the ugly remarks that you mentioned.
I still consider this sabotage, because of how disabling the illness is and the fact that science is a collaborative effort. Maybe saying that if you research ME everyone is your enemy it is a bit much, but it certainly doesn't earn you any favors. I know researchers that tried to research ME secretly in their lab and not being able to publish because the head of neurology had forbidden them from doing it. And this is not a rare occurrence, it is very common where i live - but i don't live in the US; things are probably more reasonable there from what I've seen.

Nath publishing significant findings would hopefully alter this. It's a shitty mentality to approach science in general though.

 

[B_V]

This was almost surely due to great friction and i would bet money the BPS brigade had connections at NIH and tried their best to sabotage the whole thing, not to mention the general skepticism most neurologists have about ME being a real illness and deserving any sort of research.

This is complete conjecture, i.e. you're making it up.