Information Commissioner's Office orders release of PACE trial data

[alex3619]

What is extraordinary to see is the amount of expensive legal research that went into denying this FOI claim.

Which just goes to show the absurdity of all this. They hide behind a vexatious request claim, or prohibitive cost claim, yet are willing to spend far more money to defend their position than anonymizing and releasing the data would cost. Its absurd, and a violation of the concept of open data.

So it looks like either they are doing this on principle, which is a throwback to bad science, or they are doing it to hide something, which is also bad science. They cannot argue they are doing it based on time or cost constraints.

 

[alex3619]

Mild as far as ME goes (vs. housebound or bedridden), sure, but not mild compared to disability seen in other diseases.

Under most definitions "mild" CFS still means a loss of 50% functional capacity. Its mild CFS, its not mild disability. This is a nomenclature issue that needs revising. Perhaps we should do away with mild and even moderate terms, and go with something else .

 

[alex3619]

I'm amusing myself by thinking of our "highly orchestrated campaigns", which appear to be Sasha asking people to sign a petition and put the odd comment on an article.

Not to mention that most projects fall over or are massively limited in scope because we are too sick.

 

[alex3619]

In my experience, a real world GET would never let you back off if symptoms got worse.

Yes, it was less GET than pacing done badly.

 

[alex3619]

You need the critical data to reproduce especially if the research is spun as the gold standard and final authority on the subject.

Yet another reason the PACE trial cannot be Gold Standard. They failed on reporting the data.

 

[SOC]

Yes, it was less GET than pacing done badly.

Can someone explain to me the difference in the treatments between the GET arm and the APT arm in the PACE study? If the GET is not typical GET, but pacing done badly, then what was APT? Pacing done well?

Why do they have to make up their own definitions of everything? It makes it impossible to figure out what's going on. If their GET is not what everyone understands as GET, and CBT is not the CBT the rest of the world uses, and SMC is not medical care, but no treatment for ME, and pacing is goodness knows what, how is the world supposed to interpret the results of the PACE trial?

Yeah, I know....

 

[alex3619]

If the GET is not typical GET, but pacing done badly, then what was APT? Pacing done well?

My interpretation, and I would love to read something from anyone who remembers the PACE details better than I do, is that Adaptive Pacing was a deliberately highly aggressive modification of pacing.

In some pharmacological trials, drug testers deliberately pick a comparison drug (not a placebo) that is the wrong drug, or used with the wrong protocol, so has very underwhelming outcomes which makes the drug its compared to look very good.

One thing that concerns we with studies that only use summarized data, without scatter plots etc., is its very easy to hide certain kinds of issues. In some cases big pharma has published glowing results, but the data shows a small percentage of big responders, and a huge percentage of nonresponders. Yet the summarized data hides this, and they claim more people benefit.

With PACE it might be the case, and this is still unproven, that some people did much much better, hiding a moderate or small deterioration on a subset in the aggregate, or a large number of nonresponders or extremely poor responders.

 

[alex3619]

Why do they have to make up their own definitions of everything? It makes it impossible to figure out what's going on.

My hypothesis is this is deliberate. Since they use highly technical and abnormal definitions, but do define things in the literature, they can technically use their definitions while benefiting from the confusion to spin their results. This is obfuscation. Its deceptive practice. Its very mild grounds for a case of scientific fraud unless its meticulously documented and analyzed.

 

[alex3619]

If their GET is not what everyone understands as GET, and CBT is not the CBT the rest of the world uses, and SMC is not medical care, but no treatment for ME, and pacing is goodness knows what, how is the world supposed to interpret the results of the PACE trial?

I have been making this point for years. Do not forget that normal is not normal either, or that recovery is not recovery, and the use of "rigorous" as a term for this trial, and worse the term "gold standard" , are both looking very dodgy.

 

[SOC]

I have been making this point for years. Do not forget that normal is not normal either, or that recovery is not recovery, and the use of "rigorous" as a term for this trial, and worse the term "gold standard" , are both looking very dodgy.

By this logic, I'm a French model. Or Annie Gsampel. Or both.

 

[Woolie]

Actometers would have gone a long way to doing that. Except of course they dropped them halfway through the trial.

The lack of improvement on fitness tests is a pretty good indicator of non-compliance.

 

[Woolie]

Yes, what's doubly amazing about this is they had previously denied a FOI release on the grounds that the few hundreds of pounds it would cost to process the info would exceed the FOI guideline amount even though they must have had all the required data sitting right there.

...and had received millions of pounds of public money to support the research in the first place...yet they cry poor on a few hundred pounds, if that!

 

[alex3619]

The lack of improvement on fitness tests is a pretty good indicator of non-compliance.

For non-ME. Its not clear this applies to ME.

 

[Woolie]

The PACE trial was quite different to how CBT and GET are often provided. It would not surpris me if there were genuinely few harms related to CBT and GET within the PACE trial.

Yea, when you look at the descriptions of GET and APT (pacing) in the original paper, they look pretty similar. Both seem to allow for patients to have input into whether they should increase their exercise or not. I suspect therapists were pretty flexible in both.

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.

 

[RustyJ]

Yea, when you look at the descriptions of GET and APT (pacing) in the original paper, they look pretty similar. Both seem to allow for patients to have input into whether they should increase their exercise or not. I suspect therapists were pretty flexible in both.

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.

Which is another area where control has fallen down, leaving the door open to the suggestion that APT was set up to fail, and by inference, GET and CBT are better. I still find it extraordinary that CBT and GET did not have a more significant outcome than that published, in light of all the rigging and jigging.

Apologies if this point has been made previously.

 

[Woolie]

"Treatment contamination" is a jargon term that is sometimes used.

Nice term!

 

[SOC]

The lack of improvement on fitness tests is a pretty good indicator of non-compliance.

Or an inablity to improve fitness with exercise, which some PWME have reported noticing prior to a clear ME onset.

 

[Woolie]

@alex3619, @SOC, you both have good points. But since these authors don't "believe" that ME/CFS actually has any organic basis, the only explanation they can draw on for the lack for fitness improvement is lack of compliance.

You can't have your cake and eat it: either these guys accept its an organic disease, (then you can use all the arguments that entails in support of your data), or they don't. They can't go one way when it suits, and another way when it doesn't.

 

[SOC]

But since these authors don't "believe" that ME/CFS actually has any organic basis, the only explanation they can draw on for the lack for fitness improvement is lack of compliance.

Well there's another horrifying thought. If they had used the actimeters and found lack of improvement in fitness in ME patients, they might have accused them of not complying with the treatment, even if the patients had been diligently following protocol. Yet another way to mess with patients' minds.

Patient: "Really, doctor, I did everything you said. I increased exercise a tiny amount every week, even when it made me feel much worse. I want very much for this to work and make me more functional, but it isn't."
Therapist: "That has to be untrue because we see no improvement in fitness. Exercise must result in the improvement of fitness, therefore you are lying. You are not compliant, so I will have to report that GET didn't work for you because you didn't follow protocol."
Patient: "No, honestly, I did it exactly the way you wanted me to."
Therapist: "Objective measures don't lie."

The devil is in the assumptions and there are a lot of really bad assumptions in the BPS model and treatment protocols.

 

[Dolphin]

Ha! Seriously tho, does anyone have some thoughts on this? I have already had to go back and edit an earlier post, and am fearful that I may have compromised the complainant.

I don't know what you said (and best not to say it on list) but it is something people should probably be careful about. QMUL/Peter White will be looking for any reason they can to deny this request so people* should be careful what they write, esp. in this thread which I can see them reading.

*And people can contact me if they think I should edit something I said.