Information Commissioner's Office orders release of PACE trial data

[A.B.]

Strauss believed CFS was all in the mind and that patients were not really sick.

No wonder that after 30 years there is no test or treatment or any real understanding. There hasn't been a real effort to find answers because people in key positions believed they already knew everything.

The illusion of knowledge is very dangerous.

The IOM and P2P reports are signs that the paradigm is finally changing.

 

[Bob]

I have been checking back on a comment made in a paper by Knoop et al. that I am only just beginning to get the measure of. There is a passage that includes : ‘If the therapist suggests that recovery is possible, the patient expectations are raised… This is also the essence of the placebo response.’ Effectively this is saying that CBT works the way a placebo works - which seems fairly obviously so. But then it is argued that psychological therapies tend not to have as good a placebo effect as 'physical' therapies in CFS. That might be so and it would be fine as an explanation for why CBT does not turn out to work in practice. But in the context of a trial that claims that it does work it looks as if it has to be wrong after all - if, as proposed and agreed, CBT works through a placebo mechanism.

So it seems that the argument that we do not have to worry too much about a placebo effect from a psychological therapy interfering with the true (placebo) effect of the therapy in an unblinded trial makes no sense. Presumably, the implication is that CBT also has some other means of having an effect. But what would that be? The idea that you need a therapist for CBT rather than just an information booklet suggests that the key effect is raising expectations through interpersonal relationships - the placebo effect that controlled trials are normally designed to factor out.

I haven't studied the effects of sham therapies, but there could have been a control group that received SMC plus sham therapy. You'd think they might have incorporated it into the trial design seeing as they had £5m to play with.

Even SMC plus an NHS "expert patient program", or SMC plus counselling, would have been better than 3-5 sessions of SMC (plus nothing) for a control.

Or, maybe better still, give patients a weekly cash allowance so they can arrange practical support for themselves, or improve their home environment, or to improve any aspect of their lives such as paying for transport to social meetings. I would hazard a guess that quality of life outcomes would be better than the null results seen with CBT/GET.

BTW, I'm certain these people know exactly what they're doing. If I was designing a trial to maximise placebo effects in the treatment group and maximise nocebo effects in the comparison group, I would have designed the PACE trial. And then I'd plead ignorance, and down-play the significance of the methodological biases and flaws.

 

[Sam Carter]

Most other commentators have focused on more detailed issues and I think this may have allowed responses that miss the bigger problem - but it is not as if the central issue wasn't so obvious it may hardly seem worth mentioning. I have not had responses to my own comments except from a colleague of the PACE team in confidential emails. The colleague appeared happy to convey the impression of not understanding why there was a problem.

I have been checking back on a comment made in a paper by Knoop et al. that I am only just beginning to get the measure of. There is a passage that includes : ‘If the therapist suggests that recovery is possible, the patient expectations are raised… This is also the essence of the placebo response.’ Effectively this is saying that CBT works the way a placebo works - which seems fairly obviously so. But then it is argued that psychological therapies tend not to have as good a placebo effect as 'physical' therapies in CFS. That might be so and it would be fine as an explanation for why CBT does not turn out to work in practice. But in the context of a trial that claims that it does work it looks as if it has to be wrong after all - if, as proposed and agreed, CBT works through a placebo mechanism.

So it seems that the argument that we do not have to worry too much about a placebo effect from a psychological therapy interfering with the true (placebo) effect of the therapy in an unblinded trial makes no sense. Presumably, the implication is that CBT also has some other means of having an effect. But what would that be? The idea that you need a therapist for CBT rather than just an information booklet suggests that the key effect is raising expectations through interpersonal relationships - the placebo effect that controlled trials are normally designed to factor out.

I think one could argue that the therapists in the CBT arm of the trial were trained to actively encourage a placebo response in participants.

This is from page 34 of their manual.

"""
Encouraging optimism

Although it is important that you are realistic about the treatment targets that you set with participants, it is important that you encourage optimism about the progress that they may make with this approach. Although this has not been scientifically tested (to our knowledge), they are more likely to succeed if you encourage a positive expectation of therapeutic outcome.
"""

http://www.wolfson.qmul.ac.uk/images/pdfs/3.cbt-therapist-manual.pdf

 

[MeSci]

No, this is wrong. One can not recognize "lawbreakers" by their clothing choice or banners - only by their actions. I am an anarchist (specifically the anarcho-syndicalist variety, one of many lines of thought). I would certainly never deny being a "troublemaker", and I've even carried the red and black banner of the IWW.

In a society where even giving away food in a public park is "against the law", it is nearly impossible to *not* be a "lawbreaker".

I didn't mean to imply that all anarchists were violent, as I said. I don't want to commit the injustice that I am arguing against.

But it is almost always the people who are dressed like this and with those flags on UK demos who are smashing windows and setting fire to cars. If you watch numerous pieces of UK (e.g. BBC) footage that shows this clearly.

A more experienced CND activist than me (which would be practically any other CND activist than me at the time) knew this well when we were on a London demo in the 1980s, and pointed out such a group and urged us to move away from them to avoid getting caught up in any trouble. She had been on many demos and seen it happen too many times.

Maybe it's a UK thing.

 

[A.B.]

I think one could argue that the therapists in the CBT arm of the trial were trained to actively encourage a placebo response in participants.

They would say that the placebo is one of their most effective interventions, and that therefore this is part of the therapy.

In this field everything revolves around exploiting the placebo effect to give the appearance of having therapies that are effective.

 

[Large Donner]

They would say that the placebo is one of their most effective interventions, and that therefore this is part of the therapy.

In this field everything revolves around exploiting the placebo effect to give the appearance of having therapies that are effective.

Interesting that. Wesselys wife who was head of the Royal College of GPs is on the record saying that often doctors give a medication just for the placebo effect. The funny thing is though why would you bother to run something like the PACE trial to find out which of the four "treatments" was the best when you are only willing to push CBT for example or GET in terms of "exploiting the placebo effect" and not encouraging people on the SMC and APT arm in the same way?

We are already aware they had sent out notice during the trial pushing the benefits of CBT. There is no indication that the therapists or observers where giving equal encouragement on the SMC or APT arm.

This is also problematic because of the very nature of CBT and what it can be claimed to have measured, in the sense of genuine improvement or changing the way one reports back on their symptoms under pressure to appear like they are trying to change their "thinking".

 

[MeSci]

There are groups like the Animal Liberation Front. There is nothing like that within ME activism. https://en.wikipedia.org/wiki/Animal_Liberation_Front.

There aren't ME groups actively in the 3-D world trying to sabotage anything. In the internet age, anyone and everyone can write an angry e-mail. That's different to what has happened with some campaign groups like for animal rights.

There's a distinction between individuals doing something and groups doing something. And there's a distinction between just doing things in writing and then doing things in the 3-D world.

The IRA is a group of Irish Republicans (NB different from US Republicans!). So is the legitimate political party Sinn Fein.
Islamic State is a group who are - or at least call themselves - Muslims. So are millions of other people, including numerous groups, mostly peace-loving.

Does this mean that we (or anyone else) should be suspicious of all Muslims or members of Sinn Fein?

I cannot say with 100% certainty that there are no illegal or violent groups of ME sufferers or their supporters - only that I don't know of any.

The scientifically-based, law-abiding anti-animal-experimentation student society I referred to has experienced the same kind of obstruction as ME sufferers. The science faculty have refused to engage with us because they claim to fear illegal, violent animal rights activity, yet we had never engaged in any such activity, as should have been obvious from our correspondence and publications. Even our student union were obstructive, and tried frequently to prevent democratic decisions from being made supporting our carefully-drafted motions to their conference. One of their officers accused me on a forum of being abusive at the conference. I had never even been there!

The head of biology banned our ad in the student magazine. This ad was not inflammatory, it was true, and it had been used for years. We had to spend £200 and a lot of time (mine, in fact) fighting the censorship, and the head of biology lied in his own defence. We (I) won, and the ad was reinstated. No apology, of course. (All this in the final year of my first degree, when I was already struggling with housing issues and worsened health, messing up my previously-top grades and probably contributing to my failure to get the anticipated First)

This is similar obstruction and dishonesty that people and organisations fighting for justice for ME face. And it stems from the same source - government and media demonising a group in society f0r political reasons.

I expect it also occurs with groups who fight for causes I don't agree with!

 

[SOC]

I think one could argue that the therapists in the CBT arm of the trial were trained to actively encourage a placebo response in participants.

This is from page 34 of their manual.

"""
Encouraging optimism

Although it is important that you are realistic about the treatment targets that you set with participants, it is important that you encourage optimism about the progress that they may make with this approach. Although this has not been scientifically tested (to our knowledge), they are more likely to succeed if you encourage a positive expectation of therapeutic outcome.
"""

http://www.wolfson.qmul.ac.uk/images/pdfs/3.cbt-therapist-manual.pdf

Which makes it all the more egregious that they only used subjective measures which assess patients' perceptions or how they answer questions, instead of any actual physical improvement.

 

[SOC]

What I think we can say is that the researchers don't know of any, otherwise they'd be siting them in their complaint, rather than being ludicrous and talking about Phoenix Rising. Given that, I'd be hugely surprised if any existed, at least in this country.

Agreed. I think if there was an organized violent militant group of ME patients, someone here at PR would have heard of it. I've never heard any reference to such a thing. After all, does an organized violent militant group really exist if they never commit any violence and nobody in the community has ever heard of them? No talk and no action does not a militant group make.

Even the individual so-called threats I've heard about were all huff and puff and relatively innocuous. That doesn't make them right, it just means they don't qualify as violent, and only count mildly as real threats.

Individual people have apparently written some nasty insulting emails. That happens in every public arena. Ask any politician or celebrity. I'll bet you can't find one public figure who hasn't gotten a nasty letter from some crazy. It's not good or decent, but it happens all the time. It is in no way unique to PWME. A couple of nasty letters to an actor don't make film fans threatening fan-terrorists. A bagful of nasty letters to a politician doesn't make voters violent voter-terrorists. The lunatic fringe doesn't define any group. Often they are not even part of the group at all, they're just trouble-makers in it for the thrill.

While we can't be 100% certain there isn't a super-secret organized group of violent ME-terrorists , given that there has never been any violence even to the level of knocking over trash cans, nor has anyone here ever mentioned encountering such a group, I'd say we can be 99.999999999% certain. You can't get better than that in the real world.

 

[BurnA]

While we can't be 100% certain there isn't a super-secret organized group of violent ME-terrorists , given that there has never been any violence even to the level of knocking over trash cans, nor has anyone here ever mentioned encountering such a group, I'd say we can be 99.999999999% certain. You can't get better than that in the real world.

Maybe we should start one ?
That way they would make all of us here look very tame indeed.

 

[alex3619]

They would say that the placebo is one of their most effective interventions, and that therefore this is part of the therapy.

I have seen something like this claimed more than a few times.

 

[alex3619]

Ask any politician or celebrity. I'll bet you can't find one public figure who hasn't gotten a nasty letter from some crazy.

If some, then all, even if they say it by implication.

So does this mean that if some psychiatrists abuse their patients, then all psychiatrists abuse their patients? Or a less direct claim, like many psychiatrists abuse their patients, followed by extensive discussion of abusive psychiatrists without acknowledging that the vast majority of psychiatrists do not abuse their patients? Its insidious double speak, even if only by implication.

 

[SOC]

Maybe we should start one ?
That way they would make all of us here look very tame indeed.

It's hysterical (in more ways than one) that they would suggest that PR is any kind of aggressive, hostile, abusive community. Heck, we don't even allow naughty language. It shows they can't find any real threats or abuse.

Sorry QMU, disagreement and legitimate criticism is neither harrassment nor abuse. Time to stop the smear campaign.

 

[Kati]

Hey, Snow Leopard, @Kati tweeted this yesterday:
View attachment 13544

Link: https://twitter.com/Katiissick/status/662787019324551168

I had not read this thread before now although I had seen the tweet by @Tom Kindlon quoting Graham's joke:

https://twitter.com/TomKindlon/status/662708340825284609

That could not possibly be me.

 

[Esther12]

It's hysterical (in more ways than one) that they would suggest that PR is any kind of aggressive, hostile, abusive community. Heck, we don't even allow naughty language. It shows they can't find any real threats or abuse.

Sorry QMU, disagreement and legitimate criticism is neither harrassment nor abuse. Time to stop the smear campaign.

There are a lot of people whose lives who have been made worse because of some of these researchers, and how PACE has been spun. If you see their hurt and anger as entirely illegitimate and unreasonable then it will seem aggressive/whatever. They do seem to take a lot of mere criticism as abuse too, so who knows.

 

[SOC]

That could not possibly be me.

Oh, what a militant you are! Next thing we know, you and @Sasha will be writing unflattering (to PACE) letters to politicians. The horror of it all! Oh, the humanity!*

*Hindenberg disaster reference, for those who didn't catch it.

 

[Dolphin]

The IRA is a group of Irish Republicans (NB different from US Republicans!). So is the legitimate political party Sinn Fein.
Islamic State is a group who are - or at least call themselves - Muslims. So are millions of other people, including numerous groups, mostly peace-loving.

Does this mean that we (or anyone else) should be suspicious of all Muslims or members of Sinn Fein?

I cannot say with 100% certainty that there are no illegal or violent groups of ME sufferers or their supporters - only that I don't know of any.

The scientifically-based, law-abiding anti-animal-experimentation student society I referred to has experienced the same kind of obstruction as ME sufferers. The science faculty have refused to engage with us because they claim to fear illegal, violent animal rights activity, yet we had never engaged in any such activity, as should have been obvious from our correspondence and publications. Even our student union were obstructive, and tried frequently to prevent democratic decisions from being made supporting our carefully-drafted motions to their conference. One of their officers accused me on a forum of being abusive at the conference. I had never even been there!

The head of biology banned our ad in the student magazine. This ad was not inflammatory, it was true, and it had been used for years. We had to spend £200 and a lot of time (mine, in fact) fighting the censorship, and the head of biology lied in his own defence. We (I) won, and the ad was reinstated. No apology, of course. (All this in the final year of my first degree, when I was already struggling with housing issues and worsened health, messing up my previously-top grades and probably contributing to my failure to get the anticipated First)

This is similar obstruction and dishonesty that people and organisations fighting for justice for ME face. And it stems from the same source - government and media demonising a group in society f0r political reasons.

I expect it also occurs with groups who fight for causes I don't agree with!

It is a pity that happened to a cause close to you. But by going along with your line, the same negative effects by association could happen to the ME cause by saying we're the same as animal rights; Sinn Fein and the IRA; or whatever. I find that frustrating. We shouldn't be looking for extra problems.

There are some proactive groups out for some causes there causing problems in the 3-D world. Unfortunately they cause problems for many people associated with the general cause who are acting in a peaceful way.

However, there are no named groups associated with ME that have said to be involved with terrorism or damaging property. I don't accept we are like animal rights where there have been one or more such groups; Sinn Fein and the IRA; or the other example you give; etc.

Not every cause is tarred as being a particularly problematic group. We should not be encouraging comparisons with such groups.

 

[Kati]

Oh, what a militant you are! Next thing we know, you and @Sasha will be writing unflattering (to PACE) letters to politicians. The horror of it all! Oh, the humanity!*

*Hindenberg disaster reference, for those who didn't catch it.

Well my rules are

1) pick your battles
2) address issues outside our community
3) if you can't be there in person, the social media is a most excellent way to share information.

Politicians? Hell ya. All around the world. We have voted these people in positions of power. They have to work for us.

 

[SOC]

Well my rules are

1) pick your battles
2) address issues outside our community
3) if you can't be there in person, the social media is a most excellent way to share information.

Politicians? Hell ya. All around the world. We have voted these people in positions of power. They have to work for us.

I dunno, Kati. At the rate you're going, we may find you kicking over trash cans in front of the House of Parliment in another 60-70 years.

(I admit I'm overtired and getting punchy, but mental images of 90-100yo ME "militants" acting up by kicking over trashcans has me giggling like a school girl. It may take six of us and our wheelchairs to overturn one trashcan, but darned if we aren't going to make ourselves heard!

Seriously, we have been SO tame compared to other groups, yet we're accused of being terroristic. Maybe by the time we're very elderly and have lived with ME for many decades too long, we'll feel entitled to start acting up... in our own mild way.)

 

[Kati]

I dunno, Kati. At the rate you're going, we may find you kicking over trash cans in front of the House of Parliment in another 60-70 years.

(I admit I'm overtired and getting punchy, but mental images of 90-100yo ME "militants" acting up by kicking over trashcans has me giggling like a school girl. It may take six of us and our wheelchairs to overturn one trashcan, but darned if we aren't going to make ourselves heard!

Seriously, we have been SO tame compared to other groups, yet we're accused of being terroristic. Maybe by the time we're very elderly and have lived with ME for many decades too long, we'll feel entitled to start acting up... in our own mild way.)

I think showing the science to the right people, and responding via scientific publication like many including Tom Kindlon do is a great way to go. Secondly, attracting people like James Coyne and other figures from out of the field is a great thing.

Kicking over trashcan. Oh dear. I can't stand the noise.