Brian Walitt and his role leading ME/CFS research at the USA NIH

[Dakota15]

@Arvo I support whatever others want to pursue, and I know there won't be consensus regardless. This was the choice I made and support any strategies following. There's also behind the scenes developments that I'm not at liberty to share publicly (regarding NIH) which influenced me to be more proactive with pursuing as opposed to waiting back on.

 

[Trish]

@Arvo I support whatever others want to pursue, and I know there won't be consensus regardless. This was the choice I made and support any strategies following. There's also behind the scenes developments that I'm not at liberty to share publicly (regarding NIH) which influenced me to be more proactive with pursuing as opposed to waiting back on.

Good for you. I think everyone fighting this in the best way they can using all avenues open to us is justified in doing so.

 

[DigitalDrifter]

Now it's important not to conflate Walitt's very low quality research

Research? You mean crypto-ableist propaganda.

 

[DigitalDrifter]

"effort syndrome" (sounds eerily like IOM’s SEID, doesn’t it)

I don't recall why some patients hate SEID, it's far superior to CFS.

 

[Hutan]

Just to be clear, that quote of "Hutan" above is actually a quote of Jeannette Burmeister's X thread. I don't hate SEID (I had to google to double check the name - Systemic Exertion Intolerance Disease), and the diagnostic criteria with that name is actually my favourite.

But, Jeannette is right, Systemic Exertion Intolerance Disease does sound a lot like a fancy name for laziness, or something similar that could be fixed with a good talking to, an exercise regime and a nice set of customised goals, as does 'a problem with effort preference'.

I didn't think SEID offered enough advantages to make the effort of trying to get a new name bedded down worth it. Ha, my effort preference if you like, is to not focus on a new name, but instead use the compromise ME/CFS and find a biomarker.

 

[DigitalDrifter]

The likes of Walitt make you wonder, don’t they have better, more fulfilling, things to do w/ their professional lives than making it their mission to malign & gaslight pts?

I was going to correct you there to say it's not real gaslighting if they honestly disbelieve you, but when they say "We're not saying your symptoms aren't real", I think there's an element of deception that counts as gaslighting.

 

[Hutan]

I was going to correct you there to say it's not real gaslighting if they honestly disbelieve you, but when they say "We're not saying your symptoms aren't real", I think there's an element of deception that counts as gaslighting.

Just to be clear, again, the words in that post aren't my words. They are Jeannette Burmeister's.

The likes of Walitt make you wonder, don’t they have better, more fulfilling, things to do w/ their professional lives than making it their mission to malign & gaslight pts?

I imagine that some people find maligning and gaslighting patients both fulfilling and rewarding; the likes of Walitt don't make me wonder much about that.

 

[SNT Gatchaman]

In case not already linked above Jeannette Burmeister's piece is also at https://thoughtsaboutme.com/2024/03/20/3057/

It's a very good piece that sets out the historical concerns: some were successfully headed off by the patients but others very much came to pass. It's sobering reading following publication of the paper.

---
Going a little off topic —

However I disagree with the rejection of the IOM criteria as being "overly broad and unspecific" — it's the best one I've seen. It is relatively "short and sweet" and clinically useful. Maybe it's not ideal for research but... There's newer evidence that shows nearly all patients have OI; that patients can have OI with demonstrable cerebrovascular changes but without simple HR/BP changes; and that symptom severity tracks with the degree of reduction in cerebral blood flow. (Look at the very severe patients who can't tolerate 10° head up.) So I like the optional: OI symptoms and/or cognitive dysfunction.

And if one were to start a deep phenotyping study today, I think a 2 day CPET or some other objective demonstration of PEM, and cerebrovascular OI objective data would be satisfactory study inclusion criteria or subgroup differentiators.

Subsequent posts about whether a 2xCPET is an objective demonstration of PEM have been moved to the discussion thread on PEM.

 

[horton6]

Look at the very severe patients who can't tolerate 10° head up.

Oh, has something been published on this (aside from patient self-reports)? My experiences led me to think that it was the muscular strain of supporting my own head even partially that caused issues raising the head of my hospital bed - the impact wasn't usually instantaneous OI symptoms but rather devastating PEM. So I'd love to read some more about this!

 

[SNT Gatchaman]

I don't know if we have formal studies on the very severe. We do have —

Cerebral Blood Flow Is Reduced in Severe Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients During Mild Orthostatic Stress Testing: An Exploratory Study at 20 Degrees of Head-Up Tilt Testing (2020, Healthcare)

and

Comparison of a 20 degree and 70 degree tilt test in adolescent myalgic encephalomyelitis/chronic fatigue syndrome ME/CFS patients (2023, Frontiers in Pediatrics) —

 

[Lou B Lou]

Insightful and incisive tweets from Jeannette Burmeister, likening Wallit's rhetoric to Dianetics (Scientology ideology)




Tweet:
"Walitt ran NIH's intramural ME study. He practically sells Dianetics as science: "All experiences are psychosomatic." And NIH is like: With our reputation, who is gonna argue other than those Suppressive Persons, i.e., patients, who've failed to achieve a state of Clear? 1/3"






Tweet:
"Walitt is right about one thing: the psychosomatic label can technically be applied to just about every disease because it's rooted in junk science. It's just that NIH carefully selects the patient groups on which it unleashes Walitt and his teachings: ME, LC, and GWI. 3/3"





This is a screenshot, the text:

'Hubbard believed in the ability of Dianetics to cure illnesses, and also claimed that most pathologies had a psychosomatic origin. Psychosomatic disorders were estimated by Hubbard to include 70% of all illnesses and were exemplified by asthma, dermatitis, arthritis, allergies, some coronary difficulties, eye trouble, bursitis, ulcers, sinusitis, migraine headaches etc, while mental disorders were neuroses, psychoses, compulsions, serious depressions etc ....."

 

[rvallee]

I was not aware that Dianetics is basically psychosomatics with a different hat. It actually explains a lot.

Although the irony of psychiatry dismissing Dianetics as pseudoscientific, when it's largely the same as their own stuff. Wow. Impressive.

 

[Three Chord Monty]

Heading off topic, but just because Workwell say something, doesn't necessarily make it true. The 2xCPET does seem to show an abnormal reaction to exercise in ME/CFS. A reduced workrate at Anaerobic Threshold on the second test isn't what I and most people call PEM though. That reduced workrate at AT may or may not coincide with the crash, the feeling of being ill, the deep fatigue and pain of PEM.

It's possibly semantics, but I think it's useful to reserve the term PEM for that very distinct experience, rather than use it for any post-exertion phenomenon.

It might be semantics. But I think the more relevant aspect is that it plays a potential role when it comes to disability determinations, being specifically referred to as evidence that one might say is qualifying.

Spoiler: More on CPET as objective evidence for disability payments

I say 'might' because I've recently seen someone on Twitter who provided their test results which were apparently what one would expect to see in ME, was turned down anyway. But the sense I got was that this person may have relied too much on the strength of those results as qualifying evidence, while perhaps not providing the detail I imagine they'd want to see as far as the rest of the application package (which is extensive) goes. But that was just the sense I got, don't quote me on that. Nevertheless I don't see it as an untrue statement as far as patient community perspective goes to view results reflecting PEM as providing objective information.

Not that we should have to think this way, but an ME patient is always on the defensive and has to deal with disbelief, rhetoric, insults, and even accusations about something that's widely perceived to rely entirely on self-report and therefore unprovable. It seems to be the one validated item in a decades-long, seemingly neverending battle with skepticism.

On the issue of research misconduct...there are a few pieces that I wonder about. Todd Davenport has of course been apopleptic and calling for retraction; I imagine his strongest point may be what he's pointed to regarding the role of Anthony Komaroff as both having participated to some extent in the project, and also being a referee. I do think this should be seen as no small issue considering the issues around how patients were selected, and what case definitions were and weren't used. He played a role in the selection process. Remember, first they included Reeves. Then they said CCC/IOM or whatever. Later they changed this again. In the end they said Fukuda + IOM.

Spoiler: More on criteria used - Reeves, Fukuda, IOM, CCC?

But "Fukuda" can mean 1994. Or 2003. Or something else? Can it mean Reeves 2005? It's been years. I know @Dolphin was on top of this & could probably speak to it. Reeves 2005 was 'random digit dialing' and 'are you fatigued' and anyone answering 'yes' was more or less given a CFS diagnosis. Some were people working 48-hour weeks if I recall. And there was that Lenny Jason paper that found that a cohort of people with a dx of MDD would qualify for a CFS dx. And it's easy to spot if they claimed to use CDC 2005 or Empirical or whatever, as in the Emory psych studies. But at some point I seem to recall that there were also instances where they claimed there was something called 'Operationalized Fukuda' which apparently was Reeves 2005. And also went as far as to work with the tired people in Wichita & Bibb County GA & call it just plain Fukuda anyway & there wasn't much of anything anyone could really do about it. Now, I may not be remembering this properly, but that is my recollection.

Lenny Jason just had an article in MedPage today about the issues with Reeves 2005, in relation to a recent CDC paper, mentions something called "Fukuda Empirical Criteria" which I don't think I've ever even heard of before, and asserts that pts fulfilling Reeves 2005 are still being selected for "ME/CFS research." I'm assuming there's a thread on this, but here's the link:

https://www.medpagetoday.com/opinion/second-opinions/109274

Even if I'm getting some or much of that wrong, they still started out naming Reeves as one of the qualifying criteria, which should've generated outrage in the larger scientific community. But it was CFS, so...pfft. The noise made by the pt community forced them to drop it. But there were further shenanigans. I'm sure a lot of this has been hashed over in a thread I haven't been able to fully read, and also that Jeannette covered this in her blog, so apologies. But...that FAQ page they felt compelled to put up after the blowback about the criteria promising all pts would fulfill CCC was edited later in 2016. When presumably people weren't paying as much attention. The question about the criteria had been dropped from #1 to #10 sometime in early autumn, and it was now said that they would "consider" 1994 Fukuda & 2003 CCC 'along with other information.'

https://web.archive.org/web/20161027033201/http://mecfs.ctss.nih.gov/faq.html

The question itself was bizarre--it'd been "Will the ME/CFS patients satisfy the Canadian Consensus criteria?" and all of a sudden was "Are diagnostic criteria going to be used in the adjudication process?"

I do not remember hearing about this change at the time, though of course I could've missed it. Regardless...the IOM criteria are clinical criteria that were not designed to be used in research. They are devoid of exclusions and yes, they require PEM. Unfortunately, that requirement is satisfied by self-report. In the end they all pts fulfilled IOM, 14 "1994 Fukuda," and 9 CCC.

They didn't perform a 2-day CPET.

They started out trying to use a case definition @Dolphin has said, if I recall, is as bad as Oxford, possibly worse, and less than a year after publication of the IOM report. They changed their story. "All patients will be objectively tested for post-exertional malaise (PEM)" in the first FAQ. Then they changed it again. Plus in the first FAQ #6 asked about ME/CFS experts selecting pts & they named Unger, Lipkin, Walitt, Saligan, & Gill. Does anyone reading this trust those names? I mean, Lipkin might get an asterisk, but he's a virologist, not an 'ME/CFS' expert, and the rest to one extent or another are the epitome of who shouldn't have been anywhere near this, let along selecting patients.

In the second FAQ #9 names members of the ajudication committee: Bateman, Kogelnik, Natelson, Peterson, and...Komaroff, whose name is clearly visible on the peer review report.

Nothing against this list in particular, but, I'm sorry, I find it hard to trust that they could definitively determine that the selected pts were chosen properly. The test protocol that demonstrates the hallmark/cardinal/whatever feature wasn't employed. So how can anyone possibly know that 9 pts fuifilled CCC? Look, I don't want to get into this rude act of second-guessing diagnoses. It never goes well with arguments over people who 'recovered,' typically with NLP or exercise or LP or diet who don't know anything about the differences in criteria & insist "But I DID have CFS!" However...in research? Sorry. Why would a reasonable person trust that, in spite of every attempt they made to *not* apply criteria that would've been far more effective at selecting the pts they claimed to be studying, which they said straight up they were, until they didn't.

I don't know if this amounts to anything that could be credibly argued represents scientific misconduct. And I'm not sure how it can be linked to Walitt's garbage end product. But there is a history of researchers classifying pts as "CFS" pts when they weren't. Mary Schweitzer wrote a blog about this many years ago, how the CDC would respond to a given pilot study that produced a potentially novel finding by coming out with their own, on their own chosen cohort, which would find nothing. Dutch researchers published a study on CBT in CDC-defined CFS but dropped the 4-symptom requirement, called it CDC CFS anyway, and got it published in the Lancet. Hans Knoop recently published a glowing CBT study in CFS where they used Fukuda. Nobody cared. They still don't. NIH doesn't care & are obviously happy with this result. I can't imagine they'll take complaints seriously.

But they pulled some real crap here that I would like to think should mean something.

 

[Hutan]

A number of posts about 'whether 2XCPETs are an objective indicator of PEM' and 'the definition of PEM' have been moved to
Post-Exertional Malaise - a discussion including defining and measuring PEM

 

[Dakota15]

FYI the person processing my FOIA claim sent me this today: 'My understanding based on your descriptions is that you are concerned about potential research misconduct in the intramural study, and were looking at Dr. Walitt because he was the lead researcher. In consulting NINDS, we learned that Brian Walitt did not administer the EEfRT task. Brian Walitt also did not develop the version of the test used in the study. Nor did Brian Walitt conduct most of the data analysis. Results were reviewed and analyses were refined in discussions with Brian Walitt and others.'

(I know this could be a smokescreen, but sharing)

 

[Binkie4]

FYI the person processing my FOIA claim sent me this today: 'My understanding based on your descriptions is that you are concerned about potential research misconduct in the intramural study, and were looking at Dr. Walitt because he was the lead researcher. In consulting NINDS, we learned that Brian Walitt did not administer the EEfRT task. Brian Walitt also did not develop the version of the test used in the study. Nor did Brian Walitt conduct most of the data analysis. Results were reviewed and analyses were refined in discussions with Brian Walitt and others.'

(I know this could be a smokescreen, but sharing)

Thanks @Dakota for this illuminating/ non illuminating information. This study - what a mess!

 

[poetinsf]

'Hubbard believed in the ability of Dianetics to cure illnesses, and also claimed that most pathologies had a psychosomatic origin. Psychosomatic disorders were estimated by Hubbard to include 70% of all illnesses and were exemplified by asthma,..."

Such a timely quote. I caught upper respiratory infection this week and been struggling with cough which usually lasts a month or two. Somebody once told me it could be psychosomatic. Then a doctor later diagnosed me as asthmatic and was confident that an inhaler would cure. I could see frustration on his face when it didn't work. Nothing ever helped other than Bronkaid pills. Years later, I injured my rib while coughing, and I had no choice but completely suppress the cough with my will to avoid the pain. To my surprise, it worked and the cough went away in about a week. My guess is that the suppression broke the cycle of lung irritation from cough, resulting in more cough and more irritation. I tried to replicate it in later episodes without the rib injury, but it was impossible. These days I get on Bronkaid as soon as possible to prevent irritating my lung and perpetuating the problem.

Psychosomatic feature is probably a part of any sickness. (I'd guess my cough problem is about 15% interoceptive and 85% asthmatic). But calling a sickness psychosomatic or interoceptive disorder is like calling Canadian Bacon Pizza a pineapple dish because it contains bits of pineapple.

 

[Hutan]

FYI the person processing my FOIA claim sent me this today: 'My understanding based on your descriptions is that you are concerned about potential research misconduct in the intramural study, and were looking at Dr. Walitt because he was the lead researcher. In consulting NINDS, we learned that Brian Walitt did not administer the EEfRT task. Brian Walitt also did not develop the version of the test used in the study. Nor did Brian Walitt conduct most of the data analysis. Results were reviewed and analyses were refined in discussions with Brian Walitt and others.'

Thanks very much Dakota.

That still leaves a lot of room for Walitt in that task. As lead researcher he must have approved it, and probably commissioned the test.
Developing the version of the test used the study is of relatively little consequence once a decision to do this sort of test was made - other than they seem to have mucked things up and produced a confusing mess of motivations for participants to deal with.
Administering it I presume means being there to tell the participants how to do it - any junior scientist or research nurse could have been used for that.
Same for analysing most of the data, which includes putting the data in a spreadsheet. It sounds as if Walitt did do some of the data analysis.

And it's clear that Walitt was involved in the most important bit, the 'reviewing of results and analyses'.

So, they can slice and dice it however they like, Walitt's fingerprints are all over the EEfRT task, he is responsible for it happening and for the interpretation and presentation of the data - the two points for decision making of substantial consequence. I guess Nath is equally culpable.

 

[Arvo]

FYI the person processing my FOIA claim sent me this today: 'My understanding based on your descriptions is that you are concerned about potential research misconduct in the intramural study, and were looking at Dr. Walitt because he was the lead researcher. In consulting NINDS, we learned that Brian Walitt did not administer [1]the EEfRT task. Brian Walitt also did not develop the version [2]of the test used in the study. Nor did Brian Walitt conduct most [3]of the data analysis. Results were reviewed and analyses were refined in discussions with [4] Brian Walitt and others.'

(I know this could be a smokescreen, but sharing)

I certainly reads smokescreeny, with carefully chosen language. (Thank you for posting it here as well.)

1) He was the lead associate investigator and coordinating the study alongside Nath, of course he did not "administer" it himself.
2) That immediately makes me wonder if he did develop an earlier/original version of it, which then got tweaked by others
3) He did conduct data analysis though; if he did did 48% he did not do most, if he did just on the EEfRT and/or fMRI hand grip test he still did not do most. Which data did he analyse?
4) Yeah, but that's an issue: were results "reviewed" and analyses "refined" to slot them into Walitt's interoception/effort preference framework?

Brian Walitt (together with others but consequently named first):

• conceived and designed the study
  
• recruited participants and collected clinical data, research data, and samples
  
• arranged and prepared samples and/or data for analysis
  
• drafted the manuscript

 

[Sean]

Walitt is the PI and project lead. He owns every bit of it.