2025: The 2019/24 Cochrane Larun review Exercise Therapy for CFS - including IAG, campaign, petition, comments and articles

[Utsikt]

I thought the point of not wanting to retract Cochrane reviews was to keep reviewers happy and not offend them (so that researchers keep doing reviews for Cochrane).

Why would you want to keep reviewers around if their reviews are so flawed that they have to be retracted?

Surely this heavily implies that they want to keep certain opinions around, not expertise in general. Otherwise, they would use this occasion to get rid of sub-standard reviewers through voluntary attrition.

 

[Robert 1973]

I so do not understand where Trisha Greenhalgh is on this. I haven't been following closely but she seemed to be prejudiced against people with ME/CFS, blocking reasonable people on Twitter. But argues against people with Long Covid being subject to BPS ideas? And now she is retweeting Jacqui Wise's good article in the BMJ that is supportive of people with ME/CFS?

Perhaps it doesn't really matter what she thinks, although she seems to pop up in various influential places. But, does anyone understand what is going on there?

Susie Dent on Bluesky (https://bsky.app/profile/susiedent.com/post/3l364skjisk24):

“Word of the day is ‘catchfart’, from the 17th century, used of a servant who followed their master or mistress a little too closely. In today’s terms, a catchfart is someone who fawns upon the boss or who follows the political wind.”

Just saying.

 

[Robert 1973]

What about the argument that strictly defined ME/CFS with clear PEM would have been more likely to have shown adverse effects in GET/CBT trials. That might overshadow any positive results and explain why the BPS people preferred to focus on broad criteria with unexplained fatigue.

As Jonathan said, if you follow their reasoning about deconditioning and false illness beliefs, the more severe ME/CFS patients would have been the best study subjects who should improve the most. Instead, BPS'ers preferred to focus on patients with unexplained fatigue using the Oxford criteria.

Yes, but important to remember that the Oxford criteria does not preclude severe patients. The FINE trial used Oxford and included severe patients (about 10% not ambulatory, I think). And it produced a null result, which may have influenced subsequent study designs.

 

[Hutan]

I would really like to see an investigative journalist poke into the Magenta study and get some FOIs done.

I think Crawley was running the study and leading clinical services for young people with ME/CFS. And then the study started in 2015 and finished in 2019, the data was there. I expect the preliminary results were all done by the end of 2019 - the data is of the sort where you can pretty much just stick it in Excel and get the results. The pandemic is not an adequate excuse for it taking 5 years to get published.

Crawley retired from medicine and possibly the university in September 2023. The Magenta paper was submitted for publishing in October 2023 and it was published in March 2024. Crawley was not the senior author.

So, you have Magenta providing the most damning account of GET and graded activity management that you could hope to see coming out of a study run by a high-profile psychosomatic proponent.

Who slowed down the production of the paper? Was it kept it in a drawer until after the 2021 NICE ME/CFS Guidelines were published? Did the NICE committee get access to preliminary findings?

Who got the paper over the line and published?

The reason I'm writing about this here is that all this was playing out as the Cochrane Larun et al saga rumbled on. The exercise therapy review was published and the decision was made that a new review was needed at around the same as Magenta finished up.

Did the publication of the Magenta study in March 2024 (or rumours about it earlier) make those protecting the Larun et al review realise that there was a high risk of a new review now not producing the story they wanted and that the process needed to be stopped at all costs? Yes, Magenta is a study of children and young people, but it still makes anecdotes and survey data reporting physical and emotional harm credible. And there are plenty of similar anecdotes from adults.

Some of the psychosomatic proponents might have been willing to have a protocol that separated people into two groups, with PEM and without PEM, with different recommendations for each. But, the Magenta study would have made that hard, because the criteria used did not require PEM, it was the 2007 NICE criteria, and the severity of the participants was only mild and moderate. And GET didn't work for them.

Come September 2024, and the Cochrane Board decides that the new review will not proceed. I find it hard to believe the Cochrane Board could be both aware of the Magenta paper and think that the Larun et al review is giving safe advice. I assume they just aren't that interested and were happy to be advised by Soares-Weisser and the psychosomatic proponents.

Maybe we need to be giving Cochrane staff and the Board copies of the Magenta paper.

 

[Peter T]

Crawley retired from medicine and possibly the university in September 2023. The Magenta paper was submitted for publishing in October 2023 and it was published in March 2024. Crawley was not the senior author.

I had wondered if Crawley’s retirement was a factor in the timing of the Magenta publication, given the study undermines a major component of her clinical and research career, though some other of her previous papers were also slow to get into print.

However in relation to Cochrane it maybe we will never fully understand what actually happened without a whistleblower or access to the minutes of the relevant meetings.

 

[Nightsong]

Weirdly, that review appears to have been published in 2018, presumably the time of the editorial note, even though the editorial note says that the review was published in 2009. I couldn't find a way to actually read the review. It is a seriously weird way to treat published papers. Even a retracted paper should be able to be accessed.

Click on "version history" in the side panel. Then, click on the DOI to the right of the 2009 version. Click on Download PDF/Full.

 

[Nightsong]

Did the publication of the Magenta study in March 2024 (or rumours about it earlier) make those protecting the Larun et al review realise that there was a high risk of a new review now not producing the story they wanted and that the process needed to be stopped at all costs? Yes, Magenta is a study of children and young people, but it still makes anecdotes and survey data reporting physical and emotional harm credible. And there are plenty of similar anecdotes from adults.

I think the massive campaign to preserve the Larun review may be in part about what is now necessary to obtain ethical approval for trials, and MAGENTA provides an interesting example of that. Looking back at some of the MAGENTA related documentation, the Cochrane review seems to be particularly important in getting the trial ethical approval. On 31 October 2016 Crawley wrote to the REC saying:

The complainants are not correct that there is “significant risk of serious, long-lasting harm”. The best quality evidence is from systematic reviews of high quality research and in in evidenced based medicine, we rely on this in preference to patient surveys. The largest systematic review to date (the Cochrane review, attached), looked carefully at harm and side effects in 1518 patients. They concluded that: “no evidence suggests that exercise therapy may worsen outcomes.”

and, in a further letter to an MP, stated:

Your constituent feels we should have warned patients about the “increasing evidence that it [GET, Graded Exercise Therapy] is potentially damaging.” I can reassure you that in fact, there is increasing research evidence that GET does not harm patients. The best quality evidence is a systematic review of the literature. Systematic reviews collect all the evidence from all studies to answer important questions. I have enclosed the Cochrane systematic review of exercise therapy for chronic fatigue syndrome. This independent review examined 8 randomised clinical studies with data on 1518 patients which concludes “exercise therapy was more effective than passive treatments or no treatment”, and had a “positive effect on people’s daily functioning”, and so on. It also found “exercise therapy was not found to worsen symptoms for people with CFS”.

In the REC's decision, it is clear that the Cochrane review (as well as NICE 2007) were crucial to their decision making:

The Committee agreed that based on the evidence provided and the review of the Cochrane report there was no evidence of risk of harm to the participants or to suggest that exercise therapy may worsen outcomes.

The Committee discussed the Cochrane review of the PACE trial which had concluded that there was no evidence that the trial would cause any harm to the participants. The Committee commented that the Cochrane review was the most stringent and rigorous review and noted that it stated that ‘patients with CFS may generally benefit and feel less fatigued following exercise therapy, and no evidence suggests that exercise therapy may worsen outcomes.’ The Committee commented that the exercise therapy used in MAGENTA is in NICE guidelines and does not solely rely on information from the PACE trial with other good research supporting its use. The Committee stated that the Cochrane report underpinned their decision that the MAGENTA trial was scientifically valid.

If Larun is withdrawn, ethics committees may just start considering the harms evidence independently, and perhaps even refusing to give their trials ethical approval.

 

[bobbler]

I think the massive campaign to preserve the Larun review may be in part about what is now necessary to obtain ethical approval for trials, and MAGENTA provides an interesting example of that. Looking back at some of the MAGENTA related documentation, the Cochrane review seems to be particularly important in getting the trial ethical approval. On 31 October 2016 Crawley wrote to the REC saying:

and, in a further letter to an MP, stated:

In the REC's decision, it is clear that both NICE 2007 and the Cochrane review were crucial to their decision making:

And that ‘giving the benefit of the doubt this one time’ to that argument led to the results @Hutan hss described- with harm to the extent of documented suicide attempt. And I’m guessing that was reported because others who witnessed couldn’t be persuaded it was ‘something else’ this one time.

I think this should be a story in itself because it can easily be summarised and yes is vital for ethics committees clearly to be having highlighted ti them - magenta should change everything , given ‘that one good grace based on I promise you this old review is the one that’s right’ showed whoever chose to take that risk against the testimony of patients among other evidence were proven to have out their faith wrongly. It should never be repeated as an excuse.

I’ll be honest though on the bigger picture, having read that Clare Gerald’s tweet citing Colin blakemore in 2018 just before the Cochrane review was withdrawn due to accuracy concerns… that they’ve just been arguing solidly to gerrymander keeping ‘something up’ at all times so they can continue their actions eg all this delay and timing has clearly been about the implementation not being in line with/further ‘compromise’ back to the dark old outdated bs of the nice guidelines.

if they didn’t have some old crap review up still they couldn’t war of attrition the nice guidelines hoping they’d never get published and weaponising if there isn’t something new then the old stands. I think back in 2019 it was all about just getting that withdrawal withdrawn to get it back on the board whatever promises with their fingers crossed behind their back bps protagonists needed to pretend they agreed to but intended to ‘work on next’

What a coup they got the withdrawal policy changed (I guess they agreed to ‘a new one’ in exchange for that or something)

Once the nice guidelines weren’t stopped then of course they were cooking what they could manage to do with the Cochrane one to use it to undermine that. First they thought they’d try and control it probably to have a contradicting review and push gif nice to be ignored. Hence all the extra but by bit bias insertion’to balance’ straightforward science with bs psychosomaticism group business by inserting those with conflicts , whilst also being happy to drain the energy of anyone else.

Maybe indeed magenta was part of it plus any other new research that doesn’t use cruddy methods etc.

But I’m not sure these people are either looking at the science or understanding it as to them everything is instead argued through politics reframing and power , hence them being so shocked about Nice.

I suspect the last few years have just been about opportunism and I’m not sure anyone was clever/mad enough to even have thought of just redating it, until someone said that adding an editorial note gives that option.

they’ve spent their time putting little or power groups together with the same small group of them but different names for the groups like Oslo consortium, COFFI, Recovery Norway which all seem to focus on sales pitches and spiel not research.

Chalder might have churned out a few iterative versions of her usual but the main push seems to have been on FND propaganda level papers (with no actual research content). I guess Crawley put her foot in it by having these things pipelined and somehow having not tightened enough bias and not switching to PROMS being the only measure.

Although is development of these coming from the same clinic? I note the PROMS papers by or involving Gladwell got pretty delayed by many years too?


I think their plan was to leave the old tosh as if it meant something and go with what I suspect was Whites suggestion in the Crawley eg al (2013) paper that PROMS were vital to ensure measures of function were removed because they didn’t give the right result and the Chalder fatigue scale alone wouldn’t cover that up/base enough. And their plan was to influence ‘how’ me/cfs could ever be measured in future.

Proms don’t measure harms … so ..

as this seems to be a key part of the implementation plan released in December Im guessing that’s why the 3month delay was imposed on telling anyone until December after this had been released.

 

[Hutan]

The Committee stated that the Cochrane report underpinned their decision that the MAGENTA trial was scientifically valid.

No wonder they're so desperate to keep Larun: if it's withdrawn, ethics committees may just start refusing to give their trials ethical approval.

Gosh. I'd say that MAGENTA has permanently wrecked any prospect of pediatric trials of exercise therapies in ME/CFS.

How fortunate that the wide sunlit plains of Long Covid and FND await.

 

[Trish]

Maybe we need to be giving Cochrane staff and the Board copies of the Magenta paper.

We already referenced it in our harms letter to Cochrane in March 2024. They clearly ignored it along with all the other evidence we provided.

 

[Trish]

I keep coming back to the passage in Martin Rücker's excellent article where he reveals the decision making at Cochrane that led to cancellation of the new review, and sacking of the IAG and writng group. The real reason, assuming it's correct is so shocking I focused on it in the weekly news item, thus:

"The Cochrane organization told RiffReporter that the decision was made at a meeting of the Governing Board, Cochrane's highest governing body, which took place in Prague from 7-9 September"
The Cochrane editor-in-chief had recently had to apologise, after much controversy, for a flawed mask review.
"According to people involved, it created a certain amount of conflict fatigue.
A foreseeable, yet again fierce, further conflict over a new ME/CFS review did not seem very attractive. This attitude, the complaints from ME/CFS patients that had been piling up for a long time, plus the constant fire from Graded Exercise advocates who wanted to prevent a review update anyway - all of this combined apparently led to the decision to abandon the project."
Article (in German) | Translation (DeepL) | Thread

So it all boils down to the couldn't be bothered. Their own lack of professionalism to see a difficult process through and stand up to bullies ruled.

Note the dates, 7-9 September 2024.

Coincidentally after a few months silence on Hilda's talkpage, I posted this on 12th September 2024:

Spoiler: My plea for action and accusation of influential interference in the process

trishrhymes
September 12, 2024 at 2:06 am


Dear Hilda,

I don’t know whether the following is within your Talk page rules, I accept that it’s up to you whether to publish it. Your page, your rules. I hope you will see that what I am saying here needs to be said, and said publicly.

_____________

I don’t wish to apportion blame to named individuals, since I have no knowledge of where blame lies, though clearly the editor-in-chief bears some responsibility.

I don’t want to hear more excuses about Covid, or funding cuts and reorganisation, or other priorities, I don’t want more flannel from Cochrane about new and better complaints procedures, I don’t want any more letters from Cochrane that don’t address any of our questions, I don’t want more assurances from you that you are making ‘steady progress’.

Cochrane has shown, with its actions and inactions where its priorities lie, and it’s crystal clear its priorities do not lie with scientific evidence, or the health of millions of people.

Cochrane’s priorities clearly lie with propping up failed paradigms favoured by their friends. They have known since Tom Kindlon’s publication on harms in 2010 that GET should not be recommended for ME/CFS, they have known since Kindlon and Robert Courtney pointed out flaws in the research that made it unsound that GET is not clinically useful.

They have known since Michiel Tack’s detailed analysis published on the Cochrane website in 2020 that the 2019 Larun paper should never have been published, and should be withdrawn.

The picture coming from Cochrane is of amateurish incompetence and lack of scientific understanding.

We at S4ME have tried, for over a year, and others have been trying for much longer, to make Cochrane take the problems with the Larun review seriously, supported by over 11 thousand petition signatories and over 70 organisations. People with ME/CFS and many clinicians and scientists agree that the Larun review causes harm and should be withdrawn. Cochrane editors have been given links to peer reviewed papers on harms, and large survey data, as well as some harrowing examples of harms.

Not once, in any of our correspondence with Cochrane, have they even acknowledged that they need to take harms evidence seriously, or indeed take any notice of it at all.

Cochrane is a disgrace, shaming its charitiable status, and apparently so tied in knots by its administrative processes and procedures that the editors can’t see the wood for the trees. The only alternative to that conclusion is that they have no intention of putting matters right, being in the pockets of proponents of exercise therapy, regardless of evidence.

There is no reason to keep the Larun 2019 review currently published with Cochrane’s name. Nobody with ME/CFS wants it, it helps nobody, and it is being used to perpetuate harm to who knows how many people.

I lie in bed today feeling angry and helpless, distressed beyond measure that we are so disregarded, treated as trash, unworthy of anyone’s efforts to set things right.

I don’t want your sympathy, Hilda, I want action, and I don’t mean another ‘monthly report’ telling us you are making progress in this or that small way.

I want you to contact the most senior people at Cochrane and tell them in no uncertain terms that this charade has to stop. They must withdraw the Larun review, and make a public and unreserved apology for the harm it has caused for years. And they must do so by October 2nd 2024, 5 years after they promised a new review in two years.

Will you act now? Please?

Trish Davis.

My comment sat there awaiting moderation, visible only to me and Hilda, for over 3 months, until after the announcement from Cochrane, when Hilda allowed my post and responded:

Hilda Bastian
December 18, 2024 at 5:23 pm
Sorry this sat here so long: I just didn’t know how to respond, and posting it without responding was also problematic.

I know it doesn’t help, as efforts haven’t been successful, but a lot of effort has been (and continues to be) put into this.
____________________

Other posts submitted on the talkpage in the silent 3 month by me and others were also suddenly released for public view by Hilda on 18th December.
________________

The only conclusion I can draw from this complete silence from Hilda from the date of the board's decision, is that she knew about it, but was forced to keep silent by an NDA, or by knowing if she broke the news before Cochrane did, it would make her persona non grata at Cochrane and cut off any hope she had of influencing them.

I hate feeling so helpless. My way of coping is to go on drafting and submitting complaints and comments to the Cochrane system where they will doubtless accumulate in a black hole.

 

[Utsikt]

I hate feeling so helpless. My way of coping is to go on drafting and submitting complaints and comments to the Cochrane system where they will doubtless accumulate in a black hole.

You’re doing so much for us, Trish. Your efforts both here and outwards enables me and others to advocate with accurate and well-articulated arguments that would have been outside our reach if it wasn’t for you. Thank you!

 

[Nightsong]

It has been pointed out to me that the DeepL PDF translation that I posted is rather badly formatted & a few sentences were not translated properly.

I've updated my post to include a properly re-formatted, Google Translated version.

 

[Caroline Struthers]

I suspect we should also be asking why Cochrane only introduced a no retraction policy when the previous editor in chief had seemingly agreed to withdraw the previous edition of Larun et al in 2017?2018.

I did ask this, and received no reply

 

[Caroline Struthers]

provider of endorsed medical guidance

They are very careful always to say their reviews are not guidance, they are unbiased (har har) evidence summaries. Which guideline developers can use. NICE decided the Cochrane review wasn't good enough [edit - I think they would not say "not good enough" but "not suitable") to use, but were careful to give reasons which didn't appear to reflect badly on Cochrane

 

[ME/CFS Skeptic]

Just noticed that Joerg Meerpohl the director of Cochrane Germany who commented on the review in the German article was also a co-author of this rapid response with Paul Garner that accused NICE of a "disastrous misapplication of GRADE methodology."
https://www.bmj.com/content/371/bmj.m4774/rapid-responses

 

[Utsikt]

Just noticed that Joerg Meerpohl the director of Cochrane Germany who commented on the review in the German article was also a co-author of this rapid response with Paul Garner that accused NICE of a "disastrous misapplication of GRADE methodology."
https://www.bmj.com/content/371/bmj.m4774/rapid-responses

Was he a part of Cochrane when he wrote that response? That would make an already bad look even worse.

 

[ME/CFS Skeptic]

This rapid response criticises the NICE guideline by referring to the Cochrane review on GET as a good example of applying GRADE:

An appropriate application of GRADE would have come to a very different conclusion, as did a recent Cochrane review of exercise in chronic fatigue syndrome using GRADE methodology: “Exercise therapy probably reduces fatigue at end of treatment (SMD −0.66, 95% CI −1.01 to −0.31; 7 studies, 840 participants; moderate‐certainty evidence)”.[2]

 

[ME/CFS Skeptic]

Meerpohl is also a member of the Governing Board so he might have been involved in the decision to cancel the planned update.
https://community.cochrane.org/organizational-info/people/governing-board/governing-board-membership

 

[Peter T]

Was he a part of Cochrane when he wrote that response? That would make an already bad look even worse.

Presumably members of Cochrane are entitled to express scientific views, unless they are hiding conflicts of interest or acting in any underhand fashion. However it may be that exerting covert pressure through the Cochrane Board to block genuine scientific investigation and obscure bad analysis is more dubious.