Facts and Myths about Chronic Fatigue Syndrome, 2022, Per Fink et al. (Danish Medical Journal article)

[Lilas]

Sorry, but these people are dangerous to me, because they demonstrate a staggering lack of ethics. Wanting to exclude contacts between researchers and groups of patients, it is to completely cut oneself off from the human reality of the disease and to consider the patient only as an object. They project onto the patients what they are (pure ideologues).

 

[Jonathan Edwards]

There were over 4,000 objections, and three members with extensive clinical experience left the committee in protest of its recommendations

Well, so if three members with extensive clinical experience did leave in protest is that so surprising if the independent review found that their treatment was a lot of old cobblers? Let's have some human reality in here. Would the faith healers have resigned in protest if faith healing was no. longer recommended?

More to the point, what were people with such vested interest doing on the committee? Aren't we being told that people with competing interests and ideologies should be kept out?

 

[Jonathan Edwards]

"From a health science perspective, it is worrying that the NICE Committee and former IOM are breaking with the principle that the medical basis is weighted heavier than ideology when it comes to recommendations for the investigation and treatment of diseases. To avoid ideological research, research into ME/CFS should involve independent researchers who are independent of the ME community [2, 5]."

I wonder if after it was published the author realised how much the argument disappears up its own backside?

But no, I guess not.

 

[FMMM1]

Yea (as someone who didn't follow this i.e. NICE guideline development closely) wasn't the complaint that the NICE guideline panel was weighted towards patients - yet those selling a product (exercise & CBT) were on the panel --- seems like asking for a standard but not wanting it to apply to you.

 

[Barry]

I wonder if after it was published the author realised how much the argument disappears up its own backside?

But no, I guess not.

That's the trouble with people who have their heads up their behinds. They are still convinced they can see the sunshine and smell the roses.

 

[Sean]

They cannot legitimately counter the criticisms, so gag and malign the critics instead, including accusing them of all the dirty tricks the regime engages in itself.

It is almost axiomatic that every accusation from them against their critics is actually a confession of their own failings.

Yea (as someone who didn't follow this i.e. NICE guideline development closely) wasn't the complaint that the NICE guideline panel was weighted towards patients - yet those selling a product (exercise & CBT) were on the panel --- seems like asking for a standard but not wanting it to apply to you.

I can't remember the exact numbers, but the proportion of patient reps on the NICE guideline committee was way below what was required to over rule the non-patient reps.

 

[FMMM1]

I can't remember the exact numbers, but the proportion of patient reps on the NICE guideline committee was way below what was required to over rule the non-patient reps.

Long winded as usual!

I seem to recall that Crawley recently made a statement* [post Savid Javid!] along the lines that the Government funding wasn't enough to include objective outcome criteria --- erto the previous research was crap - but it wasn't us, it was the lack of Government funding ---- you can't have it both ways i.e. if PACE etc. are crap (since they were unblinded and had no objective outcome criteria) then the outcome of the NICE review was correct - albeit that they got the right answer for the wrong reasons (rejecting studies on the basis of the study population rather than the unsound methodology).
EDIT - I wonder if the NICE review deliberately ignored the fact that the methodology of PACE etc. were unsound and instead deliberately focused on population indirectness - avoided acknowledging that NIHR, MRC +++ had been funding flawed research.

*read it somewhere on this forum - last month (May) ish.

 

[Trish]

I can't remember the exact numbers, but the proportion of patient reps on the NICE guideline committee was way below what was required to over rule the non-patient reps.

5 patient reps on a committee of 21 I think.

 

[Sean]

if PACE etc. are crap (since they were unblinded and had no objective outcome criteria)

PACE did use objective (or relatively objective) outcome measures, like the step test, 6 minute walk test, and employment and welfare use.

Problem is they did not use them as primary outcome measures, the results were negative, and they have done everything they can to bury those results.

They have objective data from their own study that fails to support their claim, and they are misrepresenting or ignoring it.

Even worse, they ditched the use of actimeters for outcomes mid-trial, after collecting the baseline data, because they failed to give a positive result in other studies. They are deliberately avoiding using or giving due weight to measures that could falsify their claim.

Which is about as anti-science and unethical as it gets.

 

[FMMM1]

PACE did use objective (or relatively objective) outcome measures, like the step test, 6 minute walk test, and employment and welfare use.

Thanks. My memory was that they dropped actimetry half way through the study (proffering a range of apparently conflicting "explanations"); to me the study was pretty much a waste, of £5 million of taxpayers money, at that point. I would have liked to see the study carried out as designed i.e. including actimetry - might have saved 10 years in revising the NICE guideline +++.

I hadn't recalled/picked up that they had some objective indicators* which could have been reported but --- they would have told the wrong story! Just adds to the case against them.


*"There was no significant improvement on any of the trial's objective measures, such as numbers returned to work or levels of fitness. The results of the 6-minute walk test showed that ME/CFS patients remained ill enough to be on the waiting list for a lung transplant (Vink, 2016). The number of patients claiming state sick pay and disability benefits increased and the number of patients in receipt of income protection or private pensions in the CBT and GET groups actually doubled (Vink, 2016)"
https://www.researchgate.net/public...alomyelitis_Chronic_Fatigue_Syndrome_A_Review

 

[FMMM1]

they are (pure ideologues)

You're entitled to hold unfounded beliefs - we all do it. However, it is e.g.:

• when they are funded (using public money) to carry out flawed research aimed at propagating those beliefs;
• when these unevidenced views form part of public policy e.g. old NICE guideline; or
• when these unevidenced views are promoted from an organisation with public esteem - Royal Colleges, universities ----

that it crosses a line.

 

[Sean]

You're entitled to hold unfounded beliefs

I don't think that we are 'entitled' to. But do think that trying to enforce the requirement of justified belief too vigorously has very serious technical problems and socio-political dangers.

 

[FMMM1]

Just saw that Fink paper is now largely behind a paywall. The pdf still seems accessible: https://ugeskriftet.dk/files/scientific_article_files/2022-05/v12210943_web.pdf and that is archived here: https://web.archive.org/web/2022052...tific_article_files/2022-05/v12210943_web.pdf

It now needs to be manually translated though. If anyone did that, it could be worth attaching a copy here.

DEEP translation seems to be the most accurate - so I've been told!

 

[FMMM1]

I don't think that we are 'entitled' to. But do think that trying to enforce the requirement of justified belief too vigorously has very serious technical problems and socio-political dangers.

Yip I personally think they should be treated as looper pursuing their own agenda - but then I'm biased!

 

[Solstice]

PACE did use objective (or relatively objective) outcome measures, like the step test, 6 minute walk test, and employment and welfare use.

Problem is they did not use them as primary outcome measures, the results were negative, and they have done everything they can to bury those results.

They have objective data from their own study that fails to support their claim, and they are misrepresenting or ignoring it.

Even worse, they ditched the use of actimeters for outcomes mid-trial, after collecting the baseline data, because they failed to give a positive result in other studies. They are deliberately avoiding using or giving due weight to measures that could falsify their claim.

Which is about as anti-science and unethical as it gets.

If money was a problem you'd think they could just use the same actimeters twice or something. I mean, they already bought and used them, so why not use them a second time and maybe even a third during the study. Could probably even clear the data and use them for subsequent trials into their brand of horsemanure too.

 

[Snow Leopard]

If money was a problem you'd think they could just use the same actimeters twice or something. I mean, they already bought and used them, so why not use them a second time and maybe even a third during the study. Could probably even clear the data and use them for subsequent trials into their brand of horsemanure too.

It wasn't about money. They claimed that the use of the devices were too much of a burden for patients. But we know from the committee notes that they dropped the plan for actigraphy as an outcome measure straight after they discussed the Dutch meta-analysis of several trials that found there was no improvement in activity levels.

 

[rvallee]

It wasn't about money. They claimed that the use of the devices were too much of a burden for patients. But we know from the committee notes that they dropped the plan for actigraphy as an outcome measure straight after they discussed the Dutch meta-analysis of several trials that found there was no improvement in activity levels.

Was it in PACE that they basically wrote somewhere that patients were active enough anyway so it wouldn't say much? I'm probably thinking of someone who was commenting on it but it was pretty revealing. The entire basis of deconditioning is extensive bed rest and I don't think anyone enrolled in PACE could have been bedbound, and most pwME never are.

But many studies have shown that although we typically have low levels of activity, most pwME are plenty active enough to avoid that kind of deconditioning. And it's easy to check, yet no one cares in BPSland.

 

[Snow Leopard]

Was it in PACE that they basically wrote somewhere that patients were active enough anyway so it wouldn't say much? I'm probably thinking of someone who was commenting on it but it was pretty revealing. The entire basis of deconditioning is extensive bed rest and I don't think anyone enrolled in PACE could have been bedbound, and most pwME never are.

But many studies have shown that although we typically have low levels of activity, most pwME are plenty active enough to avoid that kind of deconditioning. And it's easy to check, yet no one cares in BPSland.

I'm not sure, but I think that sentiment was what led them to want to categorise patients into groups like "pervasively inactive", "somewhat active" etc so they could say that the active people didn't need to increase their activity and blame the personality characteristics of those who failed to increase their activity.

 

[Mithriel]

It is only in the past 40 years or so that most people's lifestyles have meant that they need to use leisure time to keep fit. Before that exercise was day to day work and chores then sports done for fun.

Now everyone has to keep fit but being fit enough is not defined anywhere. Should we all be running marathons? What makes someone "pervasively inactive" or "somewhat active?" The constant message that exercise is free medicine, has no downside for any disease and everyone needs to do more of it has no brakes.

Many people with ME are fairly fit. The emphasis on severe ME is welcome and long overdue but we must not forget that the majority do much more. It is the BPS people who have kept up the myth of everyone with ME being deconditioned and it was not a consideration before CFS. A runner who can only run 4 miles instead of 8 can have ME/CFS.

 

[adambeyoncelowe]

Long winded as usual!

I seem to recall that Crawley recently made a statement* [post Savid Javid!] along the lines that the Government funding wasn't enough to include objective outcome criteria --- erto the previous research was crap - but it wasn't us, it was the lack of Government funding ---- you can't have it both ways i.e. if PACE etc. are crap (since they were unblinded and had no objective outcome criteria) then the outcome of the NICE review was correct - albeit that they got the right answer for the wrong reasons (rejecting studies on the basis of the study population rather than the unsound methodology).
EDIT - I wonder if the NICE review deliberately ignored the fact that the methodology of PACE etc. were unsound and instead deliberately focused on population indirectness - avoided acknowledging that NIHR, MRC +++ had been funding flawed research.

*read it somewhere on this forum - last month (May) ish.

Nah, we acknowledged methodological flaws too. The overall ratings of low and very low for clinical trials required meeting multiple thresholds for crapness.

It's just that the BPS people only ever talk about the indirectness thing, because if they had won that argument, it might have allowed some of the low trials to become moderate and the very low to become low.

But there would still have been other issues. E.g., cost effectiveness was another issue too. But the GL only has so much space to go into everything.

5 patient reps on a committee of 21 I think.

Correct. And all the clinicians working in clinics were pro-GET and -CBT. Willie Weir and Luis Nacul weren't, but they don't work in NHS clinics.

Caroline was a research nurse so doesn't treat patients directly. Charles is an ex-GP, so doesn't treat either.

The chair and vice chair were both outsiders to ME, so came with an open mind.

Their side had the numbers to win, if they wanted to steamroll things through.