Information Commissioner's Office orders release of PACE trial data

[wdb]

My tired brain may not be analysing this well, but I don't think that Wessely's claim is even entirely logical. It fails to take into account the degree to which common/general beliefs and fact can differ. If this difference is very large, it can overcome the fact that a patient does not expect a treatment to work, if it is actually an extremely effective/ineffective treatment, which will work/not work despite their strong belief that it wouldn't/would.

Many of us have experiences that surprise us and are not in line with our prior expectations. Yes - our prior expectations will have some effect, but they are not the only determinants. And the degree to which they determine outcomes will vary between people, just as some people are very susceptible to hypnosis and others are not.

Not sure if I'm explaining this well or even whether it makes sense! And I am not of course intending to suggest that CBT is an effective treatment for ME.

I think it depends on the nature of the trial, I would agree that in some cases such as if you are measuring very big effect sizes, or using objective measures, or the trial is blinded so participants don't know what to expect, then the levels of expectation would not really be of any importance.

In an un-blinded trial though when measuring relatively small effects using subjective measures, then the relative size of the placebo and other biases influencing each of the results likely to be very significant, possibly the only thing separating the groups, so levels of expectation are of critical importance to control.

 

[Seven7]

Sorry I am trying to keep up with this thread but Had the data been released or not? I see some quotes on pages # so where can I find where that is coming from???

 

[skipskip30]

A lot of failures in the media are probably due to them getting their info from the Science Media Centre rather than having their own scientifically-literate journalists.

I wonder if some of them are even literate, never mind scientifically.

 

[A.B.]

And the science media center gets their info from the Wesselites...

 

[Scarecrow]

Sorry I am trying to keep up with this thread but Had the data been released or not? I see some quotes on pages # so where can I find where that is coming from???

Not yet. Following the ICO's decision, the university has 28 days to appeal.

This could still run and run.

 

[Dolphin]

I think that they made APT more controlling and limiting than it should be, in part, to help distinguish it from GET and CBT. There are still some people insisting that CFS patients should do less that they think is best for them and, despite it's flaws, I think that the results from PACE indicate that this is not useful. (It was never reasonable imo).

I'm not convinced. APT did a little worse on some subjective measures but not on objective measures. Doesn't mean they were actually worse, they could just have become more cautious and noticing more their limitations. I think being cautious is a useful strategy in the illness. Overdo things for one period and one can if one is unlucky be stuck with long-term harm.

 

[jimells]

The real difference in these conditions seems to be the exortations they gave around the treatment:
GET: This is a powerful treatment, well-validated, you can expect to recover, etc
APT: Sorry, this is a chronic condition, best you can do is learn to live with it.

So all they are testing is their ability to manipulate patients?

 

[Sean]

So all they are testing is their ability to manipulate patients?

Yes, and they didn't even do very well on that.

 

[Bob]

Imagine if it was a placebo controlled pharmaceutical trial and they told the treatment group that they were receiving a highly successful treatment that would reverse the illness, leading to a cure. And they told the placebo group that their pill would not treat the illness, but the most they could expect was to adapt the illness. That would be considered a compromised trial, to say the least! But apparently it's fine for this 'gold standard' trial.

 

[Dolphin]

The UK media love to publish stuff on extremism and militancy. Here is one of the worst - but still typical - recent examples of UK media (deliberately?) misrepresenting marches/demonstrations and distracting readers from the actual point of the demos.

Bizarrely, immediately beneath this statement from a demonstrator:

"The media twist it. We are peaceful, we are doing this in a peaceful manner, but the media focus on the 1% who cause trouble."

is a series of dramatic photos of the 1%!

It makes much more exciting copy than an interview with a peaceful demonstrator quietly explaining what the demo is about.

The disruptive idiots have infiltrated pretty-well every sizeable demo for as long as I can remember.

The media coverage then gives the public the impression that demonstrators on all issues are militant, lawless troublemakers.

Sound familiar?

(Militants might have more difficulty infiltrating a demo by disabled people, as they are always very obviously able-bodied!)

It is a pain. But as I said before, I don't accept the comparison with some other groups.
Some groups do have a small percentage who threaten or are violent e.g. the anti-capitalist protesters you link to or animal rights supporters.

This is not the case with ME: there aren't people who are being violent, using terrorist tactics, etc. We should reject direct comparisons with other groups who do have violent members.

 

[Esther12]

I'm not convinced. APT did a little worse on some subjective measures but not on objective measures. Doesn't mean they were actually worse, they could just have become more cautious and noticing more their limitations. I think being cautious is a useful strategy in the illness. Overdo things for one period and one can if one is unlucky be stuck with long-term harm.

I'm not fully convinced of anything, but seeing as we really don't have good evidence either way I don't think it's fair to jump to advising people to cut down their activity levels in the way some can. I think that advice to be cautious is often worthwhile, but that this is largely because of the way in which exaggerated claims about the benefits of exercise can mislead people.

It is difficult to know what to say when you see someone newly suffering and hoping for useful advice. I think that doctors and modern medicine can promote an exaggerated view of our understanding of health problems, and this leads to people expecting to be able to access more reliable information on how they should respond when they fall ill than is often available - when the evidence is weak following advice from others rather than doing what you find works best tends to make things worse imo.

 

[Snow Leopard]

I think it depends on the nature of the trial, I would agree that in some cases such as if you are measuring very big effect sizes, or using objective measures, or the trial is blinded so participants don't know what to expect, then the levels of expectation would not really be of any importance.

There is a minimum level of expectation, given they were willing to participate in an CBT/GET trial in the first place. If they thought CBT/GET was BS, they wouldn't be participating.

 

[SOC]

So all they are testing is their ability to manipulate patients?

It appears so. Use of only subjective measures (which measure patients' perceptions more than their physical function) suggests that the research was intended to test their ability to manipulate patients, not the patients' actual physical function. Or that was not their intent and they're just really, really bad at experimental design and changed (and measured) parameters that were not the ones they intended to study.

 

[MeSci]

It is a pain. But as I said before, I don't accept the comparison with some other groups.
Some groups do have a small percentage who threaten or are violent e.g. the anti-capitalist protesters you link to or animal rights supporters.

This is not the case with ME: there aren't people who are being violent, using terrorist tactics, etc. We should reject direct comparisons with other groups who do have violent members.

There are a very few pwME who make threatening statements, just as there is a minority of priests, teachers and politicians who are paedophiles, athletes who are dope cheats, police who are killers, etc. There is a tiny minority of members of some religions who are extremists. All parts of society have tiny minorities who are violent and criminal. With millions of people suffering from ME, it seems unlikely that none of these are in any way criminal, threatening or violent

I can tell you from experience that the anti-animal rights propaganda is just that - propaganda, encouraged by politicians and fanned by media coverage. I have campaigned for animal rights for a long time, and have never met a fellow-campaigner who is violent. I terminated the membership of a member of a student anti-vivisection group whom I suspected of writing a threatening letter and of one who wanted to release laboratory animals at the uni, because, like most animal advocates and groups thereof, ours was and is completely opposed to such behaviour.

I know that there is a tiny minority that is violent and/or threatening, and of course the media (at least in the UK) focus disproportionately on these so that readers get the impression that animal rights campaigners are dangerous lawbreakers as a whole.

But if we are going to label a whole section of society as violent lawbreakers, then to be consistent we should equally be labelling priests, teachers, politicians and police. Otherwise we are being just as unfair to those causes as others are to ours.

Violence in demonstrations is almost always committed by infiltrators who are unconnected with the purpose of the demo and are simply there to cause trouble, because they enjoy it. The law-abiding majority want nothing to do with them.

You can usually recognise the lawbreakers by their black clothing (commonly with hoods, sometimes balaclavas or masks) and black or black-and-red flags - they are usually anarchists (not to say that all anarchists are troublemakers). It's unfortunate that the anti-capitalist march made it very easy for them to blend in.

So there are parallels with us. It is the media twisting the truth and portraying a whole group of people in a negative way which is unwarranted.

 

[Dolphin]

I can tell you from experience that the anti-animal rights propaganda is just that - propaganda, encouraged by politicians and fanned by media coverage. I have campaigned for animal rights for a long time, and have never met a fellow-campaigner who is violent. I terminated the membership of a member of a student anti-vivisection group whom I suspected of writing a threatening letter and of one who wanted to release laboratory animals at the uni, because, like most animal advocates and groups thereof, ours was and is completely opposed to such behaviour.

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.

 

[jimells]

I'm sure in their minds it makes sense,

You are giving them too much credit. Their "research" is a fraud from start to finish. Instead of comparing CBT and GET to a sham treatment, their entire research program is a sham, just like most of the CDC's intramural research.

We know the NIH and CDC intended to bury the illness by their own words on their own letterhead. And Sir Simon Wessely is the common thread that ties it all together. He was a keynote speaker at a NIAID & NIMH conference in 1991 and helped develop the Fukuda 1994 definition.

Straus is dead, but Fukuda is very much alive. He currently works for the WHO and advises them on disease names, if you can believe that.

Demolishing PACE, as important as that is, is only the first step. There are many people who need to held to account, on both sides of the pond.

 

[Jonathan Edwards]

I'm still struck by the fact that there is no reply to Jonathan Edwards' point about blinding and subjective measures. I suspect it has something to do with this idea that expectations are important. It's hard to avoid the conclusion that they were testing a placebo effect.

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.

 

[Dolphin]

You are giving them too much credit. Their "research" is a fraud from start to finish. Instead of comparing CBT and GET to a sham treatment, their entire research program is a sham, just like most of the CDC's intramural research.

We know the NIH and CDC intended to bury the illness by their own words on their own letterhead. And Sir Simon Wessely is the common thread that ties it all together. He was a keynote speaker at a NIAID & NIMH conference in 1991 and helped develop the Fukuda 1994 definition.

Straus is dead, but Fukuda is very much alive. He currently works for the WHO and advises them on disease names, if you can believe that.

Demolishing PACE, as important as that is, is only the first step. There are many people who need to held to account, on both sides of the pond.

That letter show to me why moving away from "Chronic Fatigue Syndrome" including with "systemic exertion intolerance disease" would be an improvement.

 

[jimells]

You can usually recognise the lawbreakers by their black clothing (commonly with hoods, sometimes balaclavas or masks) and black or black-and-red flags - they are usually anarchists (not to say that all anarchists are troublemakers). It's unfortunate that the anti-capitalist march made it very easy for them to blend in.

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".

 

[soti]

Where do you see willful fraud in that letter? If the guy really thought CFIDS was dubious, well, turns out he was wrong, but not fraudulent in that text, so far as I can see. Or did he somewhere else falsely tell others that he didn't think it was dubious?

In any case, wrong is bad enough for us patients with lives wasted and lost, because it meant next to no money spent, for years, on adequate research, and a climate where we are discounted.

The PACE followup, with its headline contradicting what's in the text, is a better case for fraud, though even there, if one were in a mood to be generous one could (just *barely*) imagine thinking heavily clouded by other, illegitimate considerations. I never like to underestimate the power of groupthink and avoidance of cognitive dissonance in leading people to do unreasonable things.