Michael Sharpe skewered by @JohntheJack on Twitter

[large donner]

Whatever you call it whether its a model a theory or testing of a hypotheses (which is supposed to be designed to challenge the theory) therefore making it falsifiable, the BPS are busy claiming there is a functional component to every single disease anyway so that they can add MUS onto MS or cancer or arthritis etc.

They are actually lobbying for that via the ICD. The idea goes like this......

Got MS? We think you are over reacting to it. Therefore you have MUS on top of your MS.

By design the whole thing together is unfalsifiable. They just plan well ahead for when one model is knocked down so that they can just keep themselves on the gravy train. The next obvious unfalsifiable move is "chicken and egg".

What came first the disease or the behaviour/personality type?

They are shifting the game to, "you have to falsify our unfalsifiable model or you are wrong".

Sharpe has now moved onto, "all we did was compare treatments and showed CBT and GET are the best treatments by doing a comparison".

And so on and on. Its science but not as we know it!

 

[Sean]

I suggest that the hypothesis/model underlying CBT and GET used in PACE is falsifiable via the correlations (or lack of them).

No correlations between subjective self-report outcomes and objective outcomes equals no causal connections, therefore no effect from the treatments.

We already know, via Wiborg et al, from previous studies that the correlations don't hold for CBT and actimeters.

Unfortunately, PACE have not published their correlations, nor provided the data for others to be able to test them.

As to whether PACE used a model, I would say that one cannot have a trial without an underlying model of possible causal pathways. All therapies or understandings have to be based on some conceptual construct. There is no view from nowhere. All logical propositions start from somewhere. PACE itself uses the term "assumptions" about it starting point. The assumptions are their model, and they are testable, especially the one about deconditioning.

I have always thought that one of the most damning failures of the whole PACE/psychosomatic project is that they never ever tested whether patients were, in fact, deconditioned, and to a degree that explained patients' lack of activity capacity.

That they dropped actometers seemed really worrying to me at the time (and TSC minutes now show that these were dropped once they became aware of the null results from earlier trials).

A damning fact, IMHO.

 

[Woolie]

There's also the fear avoidance theory, according to which it's more the belief that exertion causes deterioration, and that postexertional symptom exacerbation means harm and illness. The PEM and CPET literature seems to have explicitly disproved this, but that's just my view.

Whether the false illness beliefs and fear avoidance theories can be disproved, and how to do so, is an excellent question for PACE authors.

Great question, @strategist. Could you ever disprove those ideas? I can't imagine any finding that would enable us to say for sure these ideas were wrong.

We can cite studies that suggest exercise has a negative effect on PwMEs' physiology. So that shows there's may be some basis for our fear. So its not entirely pathological. But they could still say that the fear exceeds what is jusitified by the consequences. And so the long day wears on.

 

[Sean]

Simon Wessely has quietly sneaked out.

Just enough involvement to take any credit. Little enough involvement to deny any responsibility.

Always had my money on Wessely being the first rat off the ship. Sir Professor Simon Wessely, co-recipient of the inaugural John Maddox Prize for Courage in Standing Up For Science, is a gutless coward.

Maddox would be turning in his grave.

I am wondering whether he formally minimized his involvement to protect himself, while letting others do the dirty work of carrying out a clinical trial that he knew was flawed and biased. He is credited as having advised them on clinical trial design.

Wessely's involvement in PACE as summarized by Keith Geraghty in response to SW and Godwin,

Most important of all, the basic causal model/theory/hypothesis underlying CBT/GET, and being tested by PACE, is his. PACE was testing his baby, the very thing upon which he laid his initial claim to fame and authority.

Any suggestion that he had a minimal involvement in PACE, or nothing much invested in it, or no professional or ethical responsibility for it, is just laughable, and would not last two minutes under formal cross-examination by any competent lawyer.

Simon Wessely said "That’s not true. We started with Oxford and then added CDC 1994 when it appeared. Look at 1997 CBT trial, 1999 trial etc. We even compared the 2 in various papers. It didn’t make much difference to the results. it’s all here if you actually want to check"

If you look at the PACE reanalysis of the improvement rates after they were forced to release the data, you will see a similar statement about it not making much difference. The rate dropped from 60% to 20% (approx). How can that not be a substantial difference? Simply because they argued that the CBT group still did better (on the questionnaires) than the group that had no therapy.

So when they assert that it didn't make much difference to the results whether patients satisfied the Oxford criteria or the CDC ME criteria, they could easily be using language the same way. There may well be a big difference in the CBT group between those with ME and those without, but as long as both had better scores than the group without CBT, that was all that mattered.

Their use of English is as creative as their use of statistics, and neither move the truth forward.

Indeed, he conveniently forgot to mention that PACE modified the two alternate criteria (CDC and London ME) in ways that made them incompatible with other studies using either of those criteria, thus removing any comparison value to those other studies.

Plus, PACE patients were first selected using Oxford, then sub-grouped using the other two criteria. So the two alternate criteria groups were not clean independent samples.

IOW, we don't even know what patient groups those two criteria were selecting in PACE.

I bow at Mike G's lotus feet for so many reasons, but that he acknowledges the public policy dimension has me prostrate on the floor with gratitude

This is a very important point. Thanks to Mike G for recognising it.

Whether the false illness beliefs and fear avoidance theories can be disproved, and how to do so, is an excellent question for PACE authors.

One of the very first they should be required to answer. Fully and frankly.

 

[Woolie]

Most important of all, the basic causal model/theory/hypothesis underlying CBT/GET, and being tested by PACE, is his. PACE was testing his baby, the very thing upon which he laid his initial claim to fame and authority.

Yes, of course it was. How they have tried to distance the trial from the appalling ideas that inspired it!

 

[Hoopoe]

We can cite studies that suggest exercise has a negative effect on PwMEs' physiology. So that shows there's may be some basis for our fear. So its not entirely pathological. But they could still say that the fear exceeds what is jusitified by the consequences. And so the long day wears on.

If they are forced to acknowledge that the current fear avoidance narrative has been disproved by PEM & CPET literature, then they might change their position to patients experiencing postexertional aggravation of symptoms as result of believing that exertion will aggravate symptoms.

Sounds crazy but these people are from a milieu where it's acceptable to seriously consider that standing in magical circles and telling your illness to stop can be curative.

 

[MSEsperanza]

Some preliminary thoughts about how to categorize the PACE trial in scientific terminology -- and why this could be important.

I thought that the ME patient community and their advocates pointed to some contradictory and unlogical elements already in the underlying assumptions of the previous research and publications inspired by the BPS approach to ME/CFS, prior to the PACE trial -- (e.g. the boost and crash circle of activity)

These underlying assumptions perhaps can be described as the "BPS narrative of ME/CFS" -- a narrative does not have to be logical and can consist of different interwoven sub-narratives that, again, don't have to back each other logically.

As somebody else (sorry don't remember who and where) pointed out, the idea of the PACE trial then was a further contradiction to a fundamental part of the BPS narrative, namely that anybody who is denying an actually existing, pathological fear of exercise or anyone who believes that exercise detoriates his condition severley, would voluntarily take part in a trial testing the benefits of exercise. [edited - thanks, @Carolyn Wilshire !]

Since the trial's underlying implicit assumptions, its political and scientifical presentation (also "framing", perhaps) are part of the BPS narrative, it is difficult to seperate the trial's underlying hypthesis/ theses/ premises from the narrative.

Hm, don't know if this helps to clarify anything.

Certainly the critisism brought up by so many scientists and journalists presented theoretical sufficient arguments to revise the PACE paper and the BPS narrative of ME/CFS alike. However, it continues to be relevant in the medical practice. [ETA: see the latest example from Denmark:https://www.s4me.info/threads/danish-recommendations-on-funktionelle-lidelser.4645/ ] Why?

Perhaps it would be helpful to put all this in the wider frame of the BPS approach. IMO, to put any BPS approach in a "model" by which it would be possible to describe how the relevant spheres interact, is hubris. It is impossible to create a model, where all relevant data of the biological system, the psyche and the social milieu of a human being can be considered. It is already impossible to decide which data would be relevant.

This would be a topic for another thread, though: Is the BPS approach used as a model already a paradigm in medicine? In the rehabilitation facilities I got to know, it certainly is (e.g. for conditions such as MS, "established" neuromuscular diseases and Rheuma). As a trivial concept which just tries to acknowledge that in many illnesses psychological and social factors are relevant, and that, most notably, chronic diseases strongly affect the patients in many aspects of their life, "BPS" would be of much better use, IMO.

 

[Jonathan Edwards]

As to whether PACE used a model, I would say that one cannot have a trial without an underlying model of possible causal pathways. All therapies or understandings have to be based on some conceptual construct.

Actually this may not be true. The use of willow bark for fever was not based on any theory about prostaglandin synthase inhibition. Similarly for foxglove leaf. Gold for rheumatoid arthritis was used originally because it was thought to be useful for TB but the Empire Rheumatism Trial of gold in the 1960s was done at a time when it was accepted that it was useless for TB and nobody had any idea why it seemed to help some people with RA. If I remember rightly phenylbutazone was subjected to formal trials because somebody discovered that the benefit of another drug, that happened to be solubilised using phenylbutazone, was probably due to the phenylbutazone - with no theory attached. Chloroquine is used for rheumatic disease because by chance people using quinine in the tropics found their arthritis improved. And who knows why quinine was used for malaria.

 

[Carolyn Wilshire]

As somebody else (sorry don't remember who and where) pointed out, the idea of the PACE trial then was a further contradiction to a fundamental part of the BPS narrative, namely that anybody having fear of exercise or a allegedly false belief that exercise detoriates his condition, would voluntarily take part in a trial testing the benefits of exercise.

I'm not as sure as others of this argument. So for example, there are people with a pathological fear of spiders, sometimes so bad they avoid going anywhere outdoors, of even into cupboards. But these folks often choose to go into therapy to fix it. Even though they know that they'll probably have to meet a spider head-on at some point in the process.

 

[Barry]

Godwin responds to Sharpe:

"Any outcome is possible and must be respected"

Where PACE is concerned any outcome wasn't possible though. Original protocol outcomes weren't possible for a start once they'd made changes.

eta -plus other issues

And most certainly not respected.

 

[Robert 1973]

Whether the false illness beliefs and fear avoidance theories can be disproved, and how to do so, is an excellent question for PACE authors.

I know this seems pedantic but precision of language is important, as the PACE/BPS crowd so often pick up on it as a way to divert from the valid criticisms of their research. As far as I’m aware – and as Sharpe has pointed out on Twitter – the PACE authors do not refer to “false beliefs”. They refer to “unhelpful beliefs”. Of course, it is reasonable to infer that an unhelpful belief which needs to be challenged by a therapist in order to effect recovery is false. But they don’t use the term, as far as I’m aware.

We can cite studies that suggest exercise has a negative effect on PwMEs' physiology. So that shows there's may be some basis for our fear. So its not entirely pathological. But they could still say that the fear exceeds what is jusitified by the consequences. And so the long day wears on.

Again, I agree with your point but I’m not sure “pathological” is the right word.

If they are forced to acknowledge that the current fear avoidance narrative has been disproved by PEM & CPET literature, then they might change their position to patients experiencing postexertional aggravation of symptoms as result of believing that exertion will aggravate symptoms.

Exactly. This illustrates that at least some of their beliefs may be unafalsifiable. Just as a creationist can claim that God created the evidence of evolution to make it looks as though the earth is more than 10,000 years old, whatever evidence of organic illness is found in ME, there may remain some BPS beliefs that can only be discredited by demonstrating their unfalsifiability.

One of the difficulties seems to be in pinning down exactly what it is that they believe. Their framework appears to be able to change without being acknowledged to have been wrong – a bit like the SMC factsheet which was updated to remove falsehoods about the CDC without any acknowledgement of the error (https://www.s4me.info/threads/cdc-responds-to-false-smc-factsheet-claim.4355/page-2#post-76922)

 

[Sly Saint]

Sir Professor Simon Wessely

anyone mention Camelford yet? Maybe this could be Wessely's Law.

http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.738.9135&rep=rep1&type=pdf
https://www.theguardian.com/society/2012/mar/14/camelford-water-poisoning-inquest

 

[Trish]

I'm not as sure as others of this argument. So for example, there are people with a pathological fear of spiders, sometimes so bad they avoid going anywhere outdoors, of even into cupboards. But these folks often choose to go into therapy to fix it. Even though they know that they'll probably have to meet a spider head-on at some point in the process.

Speaking as someone with a pathological fear of snakes that makes me avoid situations where there are likely to be snakes, particularly large ones, even if they are not poisonous, and in a cage. My aversion is so bad, I can't watch snakes on TV - my kids thought it was hilarious having to tell me when I could open my eyes again when watching nature programs. I know it's irrational, but choose not to go to therapy to get over it because I don't live in an area where this fear significantly disables me. If I lived in a situation where that fear was preventing me living a normal life, I would go for the therapy, even though I know I would find it intensely unpleasant.

This is different from my fear of exercise, which is based on my repeated experience that exercise makes me significantly sicker. My fear is therefore entirely rational. It is not based on any specific beliefs about the nature of that sickness, but I see no point in going to therapy because I know that if I removed my fear of exercise I would be worse off.

I'm not sure if that addresses the point you are making...

 

[Barry]

I am pleased to see that Godwin is taking interest. I get what he is saying but it does seem a bit complicated. A simpler critique is that if you train one lot of people to try to believe they are improving and you do not train another lot then it tells you nothing useful if the first lot say they are improving and the others don't. Moreover, if the first lot show no increase in activity or work capacity you have reasonable evidence that the treatment does not do anything useful. Dr Sharpe seems to be lost even at that level.

Trouble is, their approach to trialling only has some tenuous credibility if you know absolutely for sure beforehand the underlying condition is very definitely attributable to false illness beliefs. So you cannot magically extend that trialling approach to supposedly prove the illness is due to false illness beliefs; like trying to pick themselves up by their own bootlaces. Especially, as @Mike Godwin says, if you have biased out the possibility of proving it is not due to that.

 

[MSEsperanza]

I'm not as sure as others of this argument. So for example, there are people with a pathological fear of spiders, sometimes so bad they avoid going anywhere outdoors, of even into cupboards. But these folks often choose to go into therapy to fix it. Even though they know that they'll probably have to meet a spider head-on at some point in the process.

Thank you, @Carolyn Wilshire. It's more precise to say:" anybody who is denying an actually existing, pathological fear of exercise" - At least I think that this is what the BPS approach implies. (Have edited my post accordingly)
What do you think?

 

[Adrian]

g

I think we used "model" in the paper. Putting "hypothetical" in front would be confusing, for the very reasons we've been talking about there. It confuses the idea that inspired the hypotheses being tested with the actual fully operationalised hypotheses themselves.

In psychology, to avoid this kind of confusion, we tend to only use "hypotheses" for the fully operationalised version(s) of the prediction(s), the ones that are actually put to the test statistically.

I think they refer to a model in their CBT and GET manuals. But I don't think I would call it a model as its a few boxes with lines between them. That is I don't think there is enough to tie down what they are saying.

 

[Jonathan Edwards]

This is different from my fear of exercise, which is based on my repeated experience that exercise makes me significantly sicker. My fear is therefore entirely rational. It is not based on any specific beliefs about the nature of that sickness, but I see no point in going to therapy because I know that if I removed my fear of exercise I would be worse off.

This is why their is an important difference for me. Fear of spiders is fear of a nasty feeling that you know has no long term consequence and have reason to think might go away if you practiced being with spiders. We all see children overcoming fears all the time and as adults we overcome fears - of booking airline flights or getting in to a not so warm swimming pool or whatever.

But fear of exercise for PWME is fear of harm - including long term harm. And there is absolutely no reason to think that the harm will not happen if you do more exercise. PWME do not think they are being squeamish about exercise. If they have found it unpleasant, as you say, then they have evidence of a problem that is not just due to a squeamish reaction. And even if their fear is based on reading internet forums there is no reason to think that exposure to exercise would change that.

As I said before, if PWME could be persuaded by a booklet or a chat that really exercise may seem frightening but does not make you feel ill if you try it and does not harm then they do not need CBT or GET, just a pat on the back and some encouragement. If they need CBT with all the 'cognitive' paraphernalia in the Wessely and header 1989 article they must be pretty convinced that doing exercise might be a bad idea after all - which nobody thinks when it comes to tiny harmless spiders or harmless snakes.

 

[Adrian]

Yes, if the hypotheses had been well supported, that would have provided positive support for the model. No question. It just doesn't work the same way for disconfirmation. Because people could fail to change for so many reasons - perhaps the therapists were not nice enough, there weren't enough sessions, their beliefs were too entrenched, etc.

Would a positive outcome give support for their model? If there were other potential models that were equally plausible then it would only provide support as one of a set of possible models. So to design a good experiment you need to think of other plausible explanations and design a hypothesis that separates these out.

I would argue that a failure to verify the hypothesis does provide support for disconfirmation but sufficient support to disprove. It suggests that their model is less likely.

There's also the fear avoidance theory, according to which it's more the belief that exertion causes deterioration, and that postexertional symptom exacerbation means harm and illness. The PEM and CPET literature seems to have explicitly disproved this, but that's just my view.

Whether the false illness beliefs and fear avoidance theories can be disproved, and how to do so, is an excellent question for PACE authors.

Could there be an experiment (ok not very ethical) that aimed to increase fear avoidance (and introduce it in healthy people) in order to prove the hypothesis?

 

[Adrian]

Always had my money on Wessely being the first rat off the ship. Sir Professor Simon Wessely, co-recipient of the inaugural John Maddox Prize for Courage in Standing Up For Science, is a gutless coward.

I think that when he publicly jumps ship we know we have won. He seems to do a fair bit of behind the scenes lobbying and I suspect that is still going on. But I think he will be concerned for how he is viewed in a historical context.

 

[Cheshire]

This is why their is an important difference for me. Fear of spiders is fear of a nasty feeling that you know has no long term consequence and have reason to think might go away if you practiced being with spiders. We all see children overcoming fears all the time and as adults we overcome fears - of booking airline flights or getting in to a not so warm swimming pool or whatever.

But fear of exercise for PWME is fear of harm - including long term harm. And there is absolutely no reason to think that the harm will not happen if you do more exercise. PWME do not think they are being squeamish about exercise. If they have found it unpleasant, as you say, then they have evidence of a problem that is not just due to a squeamish reaction. And even if their fear is based on reading internet forums there is no reason to think that exposure to exercise would change that.

As I said before, if PWME could be persuaded by a booklet or a chat that really exercise may seem frightening but does not make you feel ill if you try it and does not harm then they do not need CBT or GET, just a pat on the back and some encouragement. If they need CBT with all the 'cognitive' paraphernalia in the Wessely and header 1989 article they must be pretty convinced that doing exercise might be a bad idea after all - which nobody thinks when it comes to tiny harmless spiders or harmless snakes.

One can speak about the nature of "fear of exercice" in "CFS" a long time, but as a matter of fact, this fear does exist only in the wild imagination of the PACE PIs as, according to Trudie herself, they had to prevent participants in the trial from doing too much before starting to increase activity. End of it. They've proven their theory, or hypothesis, or whatever you call it, is completely wrong.