A general thread on the PACE trial!

They claim that PACE looked for harms but found none so GET is safe so they do not deny that one of the aims was to see if the treatments were safe yet the patients were told AT THE BEGINNING that the treatment was safe and could not cause them any harm or worsening of the disease so they should ignore it if they felt bad.

This is mentioned as being unscientific but just imagine the outcry if they gave AIDS sufferers a drug, told them it was safe and then sat back to see how many became sicker.

Being told all risk of harm from a trial you enter is a basic tenet of medicine so how could they get away with this. It seems criminal as well as unethical to me.

 

This is a really important point that I'm not sure I had considered before. I wish I'd added it to my BMJ response to Miller and White. There is also the fact, which I did raise, that Miller, who was on the PACE trial group as an "independent" assessor of trial safety data, had been prescribing GET for ME/CFS for many years before the trial. Had they found evidence that GET was harmful it would have had serious implications for him and most of PACE authors. Huge COI.

[Edit: changed “steering group” to “PACE trial group”]

https://twitter.com/user/status/1371111498727235589

 

don't know if this has been posted on this thread; a post by Lucibee
all mentions of actigraphy in the PACE trial
https://www.s4me.info/threads/esthe...erometer-magenta-data.9141/page-3#post-180033

eta: see also
https://www.s4me.info/threads/esthe...erometer-magenta-data.9141/page-3#post-180036

 

Want to see in plain English an example of how ridiculous the revised recovery criteria were in the £5M #PACETrial? Check out this (SF-36 PF) questionnaire. When patients initially tried to challenge this, many were dismissive despite the emperor having no clothes!



https://twitter.com/user/status/1378764273225175046

 

A Twitter thread from George Monbiot on PACE.

1. There’s an aspect of this story that I didn’t have space for in the column. This is about how the scientific and media establishment closed ranks around bad science, defending it from legitimate questioning and criticism.

2. In 2011, the Lancet’s editor, @richardhorton1, a man I otherwise admire, was challenged about major anomalies and irregularities in the PACE Trial paper he published. He dismissed the critics as “a small but highly vocal minority”. They turned out to be right.

3. In 2012, a promoter of the now-debunked claims that Cognitive Behavioural Therapy and Graded Exercise Therapy are effective treatments for ME/CFS was awarded the John Maddox Prize for defending them against what the Prize board called “intimidation and harassment”.

4. Intimidation and harassment are never acceptable. It’s true that some patients resorted to online insults and abuse, which was clearly wrong. But much of what was called “intimidation and harassment” was in fact legitimate critique of the methodology and requests for data.

5. Queen Mary University of London spent 5 years rebuffing requests for the PACE Trial data, characterising them as “vexatious”. In the media, these requests were described as “harassment”. Again.

6. But these data should have been in the public domain from the outset. When they were eventually released and re-analysed, they showed that the PACE Trial conclusions were unsafe and unsupported.

7. When patients and the scientists supporting them revealed massive methodological flaws and showed that the £5m PACE Trial had reached unsafe conclusions, it was an amazing victory for citizen science. But it was reported in the media as - you guessed it - further “harassment”.

8. Here’s something that shouldn’t need stating. Scientists should NEVER close ranks against empirical challenge and criticism. They shouldn’t deny requests for data, shouldn’t shore up disproven claims, shouldn’t circle the wagons against legitimate public challenge.

9. Some major soul-searching is in order. Why was it that massive methodological flaws in the PACE Trial weren’t picked up in peer review? Why weren’t they spotted by the steering committee and external adjudicators?

10. Why weren’t the trial data released from the outset? Why was it left to patients and independent researchers to expose the problems with a massive and expensive trial? Why did senior figures and boards continue to defend disproven claims?

11. A great injustice has been done to patients already suffering grievously from a terrible condition. On the basis of flawed findings, they’ve been told that their condition is largely psychological, and they’ve been pressed into useless and, arguably, dangerous treatments.

12. In some cases they’ve been denied benefits. Guess what? The PACE Trial was part-funded by the Department for Work and Pensions. They’ve been treated as scroungers and malingerers. In other words, the scientific mistakes were highly consequential.

13. I would like to see those who defended the bad science of the PACE Trial stepping up and accepting they made mistakes – it’s the least they owe the patients. There also seems to be a strong case for retracting the original PACE Trial papers.

 

And his article, while initially being about Long Covid, also talks about the issues with PACE.

https://www.theguardian.com/comment...spreading-long-covid-professor-press-coverage

 

An analogy occurred to me regarding the BPS framing of ME/CFS, and in particular Michael Sharpe's retort of "Patient rated outcomes were used because that is how the illness is defined":

https://twitter.com/user/status/985585182504898562



Suppose we are considering the condition where cars' engines are losing power.

MS and Co. might very likely say the condition where an engine is losing power can be defined by its exhaust note being quieter than usual, and the car speedo showing the car is not going as fast as it normally does. They decide to call the condition Combustion Fatigue Syndrome.

So they dream up some remedies: Growling Enhancement Therapy for the exhaust note, and Calibration Bypass Therapy for the speedo readings. Add some speakers so the exhaust note is louder and more exciting, and rejig the speedo calibration so it indicates 4x faster. With these therapies applied, they then claim that many engines are now fixed, because they sound like they should, and the car speedo readouts are much better.

But people say that's no good, because recovery can only be defined by checking objective things, like how fast car is really going and what loads it can carry.

But MS and Co. would likely say No, exhaust noise and speedo readings are what count - because that is how the condition is defined!

I know! This analogy is totally unbelievable, imbecilic, absurd, fatuous, incredible, immoral, etc. But here's the thing ... It is bang on the equivalent of what the BPS brigade actually pronounce regarding ME/CFS.

 

Great analogy @Barry

People want to be able to do more, whether physically or cognitively, but preferably both

 

Calibration Bypass Therapy - wouldn't that need a Hi-viz orange cardigan and hard hat though?

 

Indeed yes. Anything to jazz things up a bit could improve the outcomes.

 

What’s wrong with the PACE trial anyway?

"There have been many comprehensive analyses of the controversial PACE trial data over the last few years, but with Long Covid becoming a growing concern, and sharing many similarities with ME/CFS, what follows is an accessible “primer” for anyone new to the area.

This article explains why many doctors, researchers, and patients object to the PACE trial recommendations of Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) as treatments for ME/CFS, and why Long Covid groups are now discovering the same."

https://lcelliott2.medium.com/whats-wrong-with-the-pace-trial-anyway-257e158be9a0

 

from 2011:



"
The Lancet
8 March 2011 ·
Co-author of the largest-ever study of CFS/ME treatments, Prof. Trudie Chalder, tells us why there is such a range of therapies for the illness.

She says that patients who have been told to simply get some exercise, rather than receive professional support to do so, have often felt worse. She tells us why Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) can be successful in helping those suffering with CFS.

The PACE trial shows that cognitive behavioural therapy and graded exercise therapy are safe and effective treatments for this condition. Read more http://fb.thelancet.com/oqZ

Is this a watershed moment for millions of CFS sufferers worldwide? Join the debate http://fb.thelancet.com/UVd "

(Lancet link no longer works)

 

One thing I noticed from recent conversations is that as long as PACE is considered to be a psychological trial, meaning that ME is a psychological something-or-another, then it is rated on psychological standards, rather than medical ones, and so none of the flaws actually matter and nobody will care because they are standard in psychological research and there is no need to apply medical standards to a non-medical issue.

No one considers PACE to have anything to do with medicine, it's a psychological experiment dealing with a psychological problem and therefore graded on a psychological curve that allows to explicitly manipulate patients and outcomes.

I think that's why all the arguments and flaws fall flat, they are problems that are normal and not even considered problematic in psychology. Grading it on a medical curve it wouldn't even pass the laugh test. But no one does that, no sees problems with not meeting medical standards because it's not the point.

Of course there's the problem that PACE is graded on a psychological curve because it's considered that ME is psychological, in large part because of PACE. The logic is circular but no one cares because it's normal in psychological research, where standards are optional and everything is open to all the interpretation.

That's why the response is automatically a challenge to prove that ME is not psychological, an impossible feat to prove a negative, because that belief is necessary to hold PACE to a psychological standard. As long as it's graded on a psychological curve, none of the flaws matter.

I don't know what this means to us but I think that's why none of the blatant flaws matter in the end, even for people who admit them. That's why they don't consider them problematic even though they would in other medical matters, because then they apply the medical curve which it doesn't meet.

Hence why the need to "de-medicalize": the research can't meet those standards, whereas in psychology singing to your pain is considered great quality science.

Seriously though the creep of psychology into medicine is probably one of the top 10 worst mistakes in history. The ramifications are so wide and deep.

 

Yes.

 

New blog from Dr Neil Macfarlane on the PACE trial: https://drnmblog.wordpress.com/2021...-and-the-investigators-continue-to-deny-that/

This seems to have got broad approval on Twitter, but I have serious misgivings about this paragraph:

PACE has multiple problems. But all its problems are important. Some have gone after the CoI and ethical issues, but others of us have concentrated on the methodological issues. I do not understand how that can possibly risk "giving the trial a degree of credibility". Granted, we haven't had a lot of traction going after those issues, but that's mainly because there are few (if any) at The Lancet and elsewhere that actually understand stats and methodogical issues in enough detail to know *why* they are a problem.

I guess I'm slightly cross because he blithely throws the extremely hard work of so many people (Tom, Alem, Simon, Bob, Graham, John, Carolyn, Dave...) under a proverbial bus.

 

I wouldn't worry too much about Dr McFarlane. He calls himself and independent psychiatrist and seems to have a bee in his bonnet about conflicts of interest. He doesn't understand methodology. I don't think he is going to be taken terribly seriously by anyone as I suspect he has rubbed everyone up the wrong way.

I think it is important to him that psychotherapy isn't trashed in general - it is his living (his competing interest!).

 

A lot of it seems good, but in addition to @Lucibee's observation, I think this is well off the mark:

Given PACE's highly dubious entry criteria, that conclusion just doesn't hold water.

 

Strange character. Seems sort of hugely self-confident but at the same time slightly muddled. Maybe that's a psychiatry thing.