What is Action for ME's current (March 2018) position on the PACE trial?

[Sasha]

Action for ME recently joined the forums. On another thread, Clare from Action for ME (AfME) wrote:

I’m going to answer a couple of this thread’s most recent questions. Plus I’m also taking a look at other posts Action for M.E. has been tagged in.

Thanks for being willing to look at questions, Clare.

A key one for a lot of people is AfME's current attitude to the PACE trial.

AfME signed the joint open letter asking QMUL to release the PACE data to Alem Matthees, which was a good thing to have done. But I don't recall any statement from AfME that indicates that they consider PACE to have been poorly conducted or that its results indicate a failure of CBT and GET rather than the success that its authors claim. This is now a very widespread view among charities, scientists, clinicians, journalists and patients who have familiarised themselves with the critiques of PACE - and of all people, surely AfME will have read the critiques of a trial that they were so instrumental in supporting at the beginning.

AfME didn't sign the joint open letter to Psychological Medicine in March last year asking for retraction of the misleading 2013 White et al. paper about 'recovery' in the PACE trial. When challenged about this, they published a statement (my bolding):

Letter to Psychological Medicine re the PACE trial
March 15, 2017

This week an open letter, signed by a number of clinical and research professionals, and charity representatives, has been sent to the journal, Psychological Medicine. It asks the journal’s editors to retract a 2013 paper, Recovery from CFS after treatments given in the PACE trial.

Since its publication, Action for M.E. has been repeatedly asked to sign this letter, and we are pleased to make our position clear.

Any decision to support this letter would need to be taken by our Board of Trustees, and no approach was made to us in advance of the letter being published. Given that the letter has been already sent, and that getting our Board members together would take at least five working days, Action for M.E. is not in a position to sign at this point in time.

On our website, we acknowledge that scientific debate continues around the results of the PACE trial, with a number of researchers in the M.E. field and beyond questioning its findings. We also highlight that, following the release of anonymised data from the PACE trial, a December 2016 paper published in the peer-reviewed journal Fatigue: Biomedicine, Health and Behavior concluded that "the claim that patients can recover as a result of CBT and GET is not justified by the data."​

Clare, as far as I'm aware, AfME never signed the letter - even though a year has now passed, which is obviously ample time for the board to have considered it.

Also, the statement avoids stating that AfME considers that the recovery results are null. It 'acknowledges debate' on the issues, and notes that someone else has said that the results are null.

What, now, is AfME's own, actual position on PACE's methodology and its claims that CBT and GET can improve patients' health and lead to recovery?

(If anyone is in email contact with AfME and would like to bring this thread to their attention, I'd be grateful.)

 

[TiredSam]

@Action for M.E.

 

[Sasha]

@Action for M.E. - I note AfME's public comment today on the Wilshire et al. critique of PACE:

Action for M.E. comments:

We welcome this latest re-analysis, which adds to the ongoing scientific debate around the methodology, conduct and clinical value of the PACE trial, and a growing lack of consensus among experts regarding the efficacy of CBT and GET for M.E. and/or CFS.

Specifically, we support this study's conclusion that research into effective treatments must move away from behavioural approaches and focus instead on the pathophysiology of the condition and its phenotypes. Action for M.E. actively supports investment in collaborative research that helps us stratify the illness, identify biomarkers, and ultimately lead to better treatments, and hopefully a cure.

We would also like to highlight our concerns regarding the Science Media Centre statement, published yesterday in advance of the re-analysis, and its dismissal of the significant scientific debate, and the growing lack of consensus, about appropriate treatments and clinical guidelines for M.E. and/or CFS.

This lack of consensus is evidenced by the decision taken by the Centers for Disease Control and Prevention, the leading national public health institute of the United States, to stop recommending CBT and GET, following careful consideration of peer-reviewed research, including the Institute of Medicine (IOM)’s 2015 report on M.E.

This has considerable implications for the current review of the National Institute of Health and Care Excellence (NICE) clinical guideline for M.E./CFS in the UK, given that NICE has an ethical obligation to present a full, accurate and balanced picture of current international clinical practice – including the lack of international consensus around the efficacy of CBT and GET. Action for M.E. will continue to highlight this to NICE throughout its consultation on its guideline for M.E./CFS.​

I am disappointed in this. Once again, you are reporting that other people are criticising PACE and you are saying that there is 'debate' about PACE and a 'lack of consensus' about the use of CBT and GET for ME/CFS. You say you want research to move away from behavioural approaches.

But what is AfME's view of PACE? What is AfME's view of the efficacy of CBT and GET?

There is a fence that no one should now be on, but you are sitting firmly astride it.

Why?

Will you ever stop?

 

[Aimossy]

Agreed - there is no debate now re PACE and it's version of CBT and GET for ME/CFS. There is no lack of consensus when it comes to scientists and researchers who are concerned with people with ME/CFS best interests.

I would like to see Action for ME clarify their stance on PACE as well. Their language is sounding like a standard mantra to me that reads like it is not firmly backing the current state of knowledge - or patients on this matter. Regardless of stating the obvious biomedical approach need.

 

[Sly Saint]

Bit of background:
http://web.archive.org/web/20030804230351/http://www.afme.org.uk/news/pace-q&a.shtml

"
10. Clinicians who have advocated for CBT and GET are leading the PACE trial. Will the results be biased?

No. Everything is strictly controlled to avoid bias and the results will be recorded by researchers acting independently. The Chief Executive and Principal Medical Advisor of Action for M.E. will be members of the PACE team, and we will help to make sure that the trial is fairly conducted. The Medical Research Council insist that all their funded trials are overseen by two independent committees, who oversee the ethical and quality aspects of the trial. The main committee (the Trial Steering Committee) includes an M.E. sufferer.

11. But why do it at all? Surely enough has been spent on CBT and GET?

The researchers were going to put in for a trial of GET and CBT without pacing, with every chance their bid could be successful.

We at Action for M.E. also think that too much funding has gone into CBT and GET research compared with other research. If it was only those two we wouldn't have given our support.

However, the researchers wanted to compare CBT and GET with pacing, the approach favoured by us and the majority of our members. Since there have been no published trials of pacing, we believe this justified our support."

 

[Invisible Woman]

However, the researchers wanted to compare CBT and GET with pacing, the approach favoured by us and the majority of our members. Since there have been no published trials of pacing, we believe this justified our support."

.....and, unless I am mistaken, it wasn't pacing as we know it, but their own form of adaptive pacing which means always looking to push to do a little more.

 

[Sly Saint]

.....and, unless I am mistaken, it wasn't pacing as we know it, but their own form of adaptive pacing which means always looking to push to do a little more.

I was a member of AfME at the time and the way it was 'sold' to us was that the research was about 'pacing' as we understood it. But ordinary members (who were not online) were provided with very little information. I posted about this at the other place.
This was in the Interaction magazine in 2004.

From the same magazine, was a 4 page article on CBT (Including Hazel O'Dowd).

 

[Sasha]

.....and, unless I am mistaken, it wasn't pacing as we know it, but their own form of adaptive pacing which means always looking to push to do a little more.

I'm not sure that's an accurate description of adapative pacing therapy in PACE, @Invisible Woman - the idea with that was to stay within certain limits, IIRC. But there are signs lately of the term 'pacing' being hijacked and used to mean essentially 'graded activity'.

But I'd like to keep this thread strictly to the topic of what AfME's current position is on PACE and CBT/GET.

@Action for M.E. - Clare, are you able to answer my question? If you're consulting with the board concerning an answer, it would be helpful to know that.

 

[Three Chord Monty]

Amazing how the perpetually-hostile (towards ME) "Science-Based Medicine" blog was disgusted by PACE enough to come out hard against it--almost a year ago--and AfME can't even bring themselves to do so publicly.

Absolutely amazing.

 

[Barry]

I am disappointed in this. Once again, you are reporting that other people are criticising PACE and you are saying that there is 'debate' about PACE and a 'lack of consensus' about the use of CBT and GET for ME/CFS. You say you want research to move away from behavioural approaches.

But what is AfME's view of PACE? What is AfME's view of the efficacy of CBT and GET?

There is a fence that no one should now be on, but you are sitting firmly astride it.

I really do agree with this. I think @Action for M.E. is at a pivotal point in its history, and history will judge it so. AfME is not supposed to simply be a media outlet, reporting on what everyone else thinks and says, it is supposed to be a profoundly active participant. If this does not happen very soon, @Action for M.E. will look like it is still trying to hedge its bets, waiting to see which side is likely to win, rather than jumping in and to hell with it - fight for what is right ... for PwME!

 

[Amw66]

Generally appeasement is not a good tactic- history shows it dosn' t end well

 

[Jonathan Edwards]

Bit of background:
http://web.archive.org/web/20030804230351/http://www.afme.org.uk/news/pace-q&a.shtml

"
10. Clinicians who have advocated for CBT and GET are leading the PACE trial. Will the results be biased?

No. Everything is strictly controlled to avoid bias and the results will be recorded by researchers acting independently. The Chief Executive and Principal Medical Advisor of Action for M.E. will be members of the PACE team, and we will help to make sure that the trial is fairly conducted. The Medical Research Council insist that all their funded trials are overseen by two independent committees, who oversee the ethical and quality aspects of the trial. The main committee (the Trial Steering Committee) includes an M.E. sufferer.

This is an interesting bit of history.

The key question here is who at the MRC authorised this sort of erroneous statement? PACE was not controlled to avoid bias. It was set up to maximise bias. AfME can be forgiven for not understanding this if they did not have competent medical scientific advisers but how come the MRC persuaded them of this when no competent clinical scientist could claim this?

 

[Daisybell]

Glad to see @Action for M.E. signing the letter to the Times. This seems to signal a change in position....

 

[Sleepyblondie]

Action for ME seem to always come late to the party. It’s a bit late now to sign the letter to the Times. Why weren’t they fighting our corner all along? I was a member. I wasn’t even allowed to comment on their Facebook page. They constantly claimed I wasn’t blocked, but they never sorted out the problem. Censorship seems to suit them far more. I’m bitterly disappointed with AfME. I regret every penny I spent on subs. They don’t seem to me to act for people with ME, more like acting against people with ME

 

[Andy]

Glad to see @Action for M.E. signing the letter to the Times. This seems to signal a change in position....

Was just about to post on this point.

How is it that they are happy to be signatories on that letter, which condemns GET as potentially damaging, but then present GET in as a neutral way as they can on their website, https://www.actionforme.org.uk/reso...e-evidence-for-using-graded-exercise-or-gat/? I would argue, as the charity many people who are newly diagnosed will look to for information, that having the information in the format of "here is what is said about this so-called treatment by both sides of the argument, now you the patient need to decide whether or not to have it" is borderline negligent, especially if they actually support what has just been written in the letter.

They have just signed a letter saying

The “exercise will make you better doctrine” applied to ME/CFS is profoundly incorrect and has no scientific evidence base. The human cost is enormous, with many sufferers from ME/CFS rendered worse by inappropriate medical management.

and yet they leave it to the masses of newly diagnosed to figure it out for themselves whether they should have GET.

Short answer to, currently, what their position is on PACE and the associated 'treatments'? Who knows, as it seems to range from neutral (but implicitly give some weight to it by hosting details of the counter claims by the BPSers) to implicitly against it (as evidenced by the recent letter)?

 

[Alice]

@Action for M.E. - I note AfME's public comment today on the Wilshire et al. critique of PACE:

Action for M.E. comments:

We welcome this latest re-analysis, which adds to the ongoing scientific debate around the methodology, conduct and clinical value of the PACE trial, and a growing lack of consensus among experts regarding the efficacy of CBT and GET for M.E. and/or CFS.

Specifically, we support this study's conclusion that research into effective treatments must move away from behavioural approaches and focus instead on the pathophysiology of the condition and its phenotypes. Action for M.E. actively supports investment in collaborative research that helps us stratify the illness, identify biomarkers, and ultimately lead to better treatments, and hopefully a cure.

We would also like to highlight our concerns regarding the Science Media Centre statement, published yesterday in advance of the re-analysis, and its dismissal of the significant scientific debate, and the growing lack of consensus, about appropriate treatments and clinical guidelines for M.E. and/or CFS.

This lack of consensus is evidenced by the decision taken by the Centers for Disease Control and Prevention, the leading national public health institute of the United States, to stop recommending CBT and GET, following careful consideration of peer-reviewed research, including the Institute of Medicine (IOM)’s 2015 report on M.E.

This has considerable implications for the current review of the National Institute of Health and Care Excellence (NICE) clinical guideline for M.E./CFS in the UK, given that NICE has an ethical obligation to present a full, accurate and balanced picture of current international clinical practice – including the lack of international consensus around the efficacy of CBT and GET. Action for M.E. will continue to highlight this to NICE throughout its consultation on its guideline for M.E./CFS.​

I am disappointed in this. Once again, you are reporting that other people are criticising PACE and you are saying that there is 'debate' about PACE and a 'lack of consensus' about the use of CBT and GET for ME/CFS. You say you want research to move away from behavioural approaches.

But what is AfME's view of PACE? What is AfME's view of the efficacy of CBT and GET?

There is a fence that no one should now be on, but you are sitting firmly astride it.

Why?

Will you ever stop?

Was just about to post on this point.

How is it that they are happy to be signatories on that letter, which condemns GET as potentially damaging, but then present GET in as a neutral way as they can on their website, https://www.actionforme.org.uk/reso...e-evidence-for-using-graded-exercise-or-gat/? I would argue, as the charity many people who are newly diagnosed will look to for information, that having the information in the format of "here is what is said about this so-called treatment by both sides of the argument, now you the patient need to decide whether or not to have it" is borderline negligent, especially if they actually support what has just been written in the letter.

They have just signed a letter saying

and yet they leave it to the masses of newly diagnosed to figure it out for themselves whether they should have GET.

Short answer to, currently, what their position is on PACE and the associated 'treatments'? Who knows, as it seems to range from neutral (but implicitly give some weight to it by hosting details of the counter claims by the BPSers) to implicitly against it (as evidenced by the recent letter)?

 

[Alice]

When will Action4ME start working for ME patients? The PACE trial issues are not a lack of consensus issue. A lack of consensus needs at least two valid positions to be put forward. Action4ME never seem to be able to support objective science, the PACE trial conclusions are at best misleading.

 

[Sean]

PACE was not controlled to avoid bias. It was set up to maximise bias.

This is an important message we need to get out about PACE in particular, but also any other similarly structured trials: they are basically an exercise in maximising known biases (confounders) in psycho-behavioural trials, and then simply relabeling any 'positive' results as a therapeutic benefit.

 

[Sasha]

Action for ME seem to always come late to the party. It’s a bit late now to sign the letter to the Times. Why weren’t they fighting our corner all along?

It may be a bit late but it's not too late for AfME to turn things around and start acting in the interests of patients.

I'm glad to see your name on the letter to The Times complaining about GET, Clare - @Action for M.E. - but we need a positive statement from AfME on its own website and the whole site swept through of neutral or positive assessments of CBT and GET.

If not, why not?

On your website donation page, AfME says:

Our vision is simple: a world without M.E. Your donation could help fund new biomedical research projects to unlock the causes of M.E....​

But if AfME can't see the glaring problems with PACE and the other CBT/GET studies (open-label study combined with subjective measures) then AfME is not competent to judge the quality of research submissions and should not be soliciting donations to support a research programme.

 

[Skycloud]

I think AfME have a duty of care towards patients to warn them that GET is implicated in harm to patients. I really don't think it's ethical for them to fudge this on their website.

Sick people, some very sick indeed, who are newly ill/diagnosed and may not be best placed to research and weigh up the state of play re GET need a very clear advisory warning. Especially so since NICE, at least for now, won't give one.

edit - small change to last sentence