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

Peter Trewhitt said:
Presumably the participants in the studies that are being reviewed, must have in some way consented to their data being used in such subsequent analysis. Does this mean that the original subjects could withdraw that consent? For example if many of the PACE patients withdrew there consent for their data being analysed would this entire edifice collapse?
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YES!

ETA: Carol Monaghan SNP read out in the Westminster Hall debate in 2018, an extract of a letter she received from someone who participated in the PACE trial.
 
Am I correct in thinking that the 2019 now 2024 review without the suggested editors note from the IAG only includes research on mild/moderate cases of CFS/ME?

If so, then this republished review as it stands will be used to support activity management based on a deconditioning/behavioural model of activity management not only for mild/moderate, but also for severely affected patients. Publishing this review with the new date without a note stating that it is wildly out of date breaches its own stated aim to provide gold standard evidence to enable informed treatment decisions.

From Hilda's blog dated 24 January 2025

The first of these three is the most straightforward. In cancelling the review project, Cochrane’s announcement attributed the decision to “insufficient new research in the field and a lack of resources to oversee this work.” That explanation sidesteps the fundamental reasons given for needing an update in the first place, and it’s misleading to imply the evidence and other content of this review is current. It’s not. What’s more, methods being out-of-date matters.
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Jonathan Edwards said:
So we know that the project was successfully blocked by internal vested interests.
It is time somebody high up resigned.

Gill Leng was on the governing board of Cochrane during this period. Why did she not blow the whistle?
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Indeed, and is the change to them trying to claim it is OK to insist noone can write to an individual person (although a pertinent question is whether this includes the bps advocates engaging in back-channel/informal communications as per the FOIs for the Nice process?) and all replies will not be for an individual person actually something that should be legally permitted given the formal definition of foreseeability ?

Surely someone cannot remove the right to tell someone of the foreseeable consequences and log this?

We've seen with the post office and all sorts of other areas the hiding behind a corporate blob and pretending the comms didn't all get to the same individuals - this seems to be almost creating that situation being the apparently only one possible. But really can/should someone be allowed to actually stop someone being informed? Don't individuals actually still have personal responsibilities and accountaibilities just as a fundamental part of being a citizen and their job and role .. no matter what PR fibs they want to put out suggesting 'don't email me I won't read it' acts as legal cover that someone now hasn't been informed even when they were warned directly? That in itself is surely negligence to the role and responsibilities? I'm very confused by it.

I mean luckily this 'new development' is very new so actually doesn't work as cover for anything prior to end Dec 2024 anyway - but it does seem like trying things on?
 
Hilda Bastian has just posted the following on her talkpage in response to some questions I asked there a few weeks ago.
https://hbprojecttalk.wordpress.com/2024/12/18/brief-message/

Hilda Bastian
January 26, 2025 at 8:20 am
Hello Trish

The reason I hoped to get back to you by the end of January is that I wanted to wait until both the IAG and I had organized our public responses. That leaves me able to speak more freely, and as well, there is information relevant to several of your questions in those public statments:

I’ll summarize your questions from this string here, but please let me know if I’ve missed anything. This is a response on my own behalf, not speaking for the IAG.

About the protocol

As I reported in November 2023, [1] we were expecting Cochrane editors to sign off on the review, but still waiting for that. The IAG was maintaining independence in this process, and we were going to form our own opinions about the protocol.

At that time, the project needed to be fully re-configured, as the Cochrane groups that had formed the editorial structure had been disbanded. [1] This was complicated, as the new Cochrane editorial system was still in development. It also required resource decisions to be made, as well as clarity on project management. I did not press them on the protocol, because I wanted to be confident all the structures and project planning were in place for it proceed in a timely manner. I did not want to have another start that faltered at organizational or priority barriers. And I did not want there to be any impression that delays were because of the IAG taking too long with the protocol.

In terms of the IAG role with the protocol, our first one was to recommend peer reviewers. We wanted to be ready with that, so it wouldn’t be a cause of delay, and so that peer reviewers could be recruited and have the timeline in their calendars. While I was working with Cochrane staff to develop the timelines and structures in 2024, at the IAG we developed a list of people we were going to recommend for Cochrane’s consideration as peer reviewers. That was ready to send as soon as Cochrane gave the protocol the green light. (The plan was for us to review the protocol multiple times: before and after peer review, then again after response to public consultation, and the proposed final version.)

Long story short: We were ready to comment on the protocol once Cochrane signed off on the project structure and timeline and sent us the protocol. However, this did not go as expected.

Whether or not the authors can or will release the protocol is a matter for them. I am not encouraging them to do so. I still haven’t asked to see the protocol.

IAG consultation document on critiques

We had provided a first draft of our content analysis for the authors’ consideration very early on. We developed a consultation document around it, and completed the infrastructure for that. It had taken a long time to get to the point where it was clear the project was moving enough to justify asking the community to contribute their time. After we were finished our list of recommendations for peer reviewers, I had started thinking through what to do about it being so out-of-date.

What we will publish and when is on the IAG’s to do list.

The IAG’s recommendation for an editorial note

As you know now from our Open Letter, we had recommended a note that said the review was out of date and should not be used for clinical decision-making. There was also a statement that the review was being updated.

The S4ME complaints

I reported in my blog post that I had been pursuing this within Cochrane, with some, but not complete, success. In my December 2023 report, [2] I spoke about this is in general terms, including about a meeting I called for out of concern about how this was being handled. In the end, there was more than one meeting. Some of the results of this are already public, via an email to you and the S4ME committee assuring you that the complaints from S4ME were now under review. [3] Happily, the Chair of Cochrane’s Governing Board personally signed it, though that was contrary to Cochrane policy at the time. This was a turning point.

It took time to go through the complaints thoroughly, as they contained many substantive points and pieces of literature, over quite some time as you know. That is the part that I can assure you was done successfully. I know this, because I curated a clear list myself to be confident about thoroughness, and provided it to Cochrane (along with a compilation of the complaints).

My strong recommendation to them was that there be a thorough investigation of that material, and that you get a detailed, and public, response. I continued to follow this up, including with the Chair at the end of his term (mid-2024). I followed it up again with staff after that, and it seemed to be on track, though moving slowly.

In December after the project was cancelled, I pursued this again. I was informed that my recommendations around investigation had been followed, but my recommendation about a public response had been rejected. I know from your public comments that no response has as yet been received at S4ME. I do not consider this final. As you know, I publicly stated in my blog post that they have not followed their policy. There, I am referring specifically to the following provision in that procedure (bolding to highlight): [4]

If a complaint is investigated, those who made the complaint will be informed of the outcome but will not necessarily be kept regularly updated in the interim.

Though I have seen no documentation beyond that I provided myself, I am confident that the investigation did take place. Therefore, you are entitled to be informed of the outcome. I have been pursuing this, and will continue to do so until you get a response. Between my blog post and my personal representations, I think it’s fair to say that my urging of Cochrane for that response to be substantive is forceful. And of course, the same applies to protesting that this happened. I am sorry that I could not get a resolution of this sooner. I have also made clear that I think their new complaints policy has problems, even if it were being followed. I will pursue that as well.

Cochrane owes you an apology.

Issuing a new version of the review for an editorial note

I had indicated previously that I was following this up. This is not the usual practice. However, I haven’t done a thorough enough search to be sure that it has never been done before for something that was only a report of updating plans. Both the IAG letter, and my own post, take issue with Cochrane’s decision to do this. In my blog post, I also criticize the lack of transparency around this. I am pursuing this.

Apologies again that you had to wait weeks for answers to your questions.

Best wishes,

Hilda



[1] November 2023 IAG report at Cochrane: https://web.archive.org/web/2024041...older-engagement-high-profile-reviews-pilot-3

[2] December 2023 IAG report at Cochrane: https://web.archive.org/web/2024022...older-engagement-high-profile-reviews-pilot-4

[3] Response of Cochrane Chair to S4ME in December 2023: https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-2#post-508709

[4] Cochrane complaints procedure: https://community.cochrane.org/orga...l-members-and-supporters/complaints-procedure
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Coincidentally I'm expecting to submit to Cochrane tomorrow a further complaint from the committee about the lack of response to our previous complaints. And hoping to find the strength to draft another one soon about the cancellation of the new review and republication of the old one.
 
Trish said:
Hilda Bastian has just posted the following on her talkpage in response to some questions I asked there a few weeks ago.
https://hbprojecttalk.wordpress.com/2024/12/18/brief-message/



Coincidentally I'm expecting to submit to Cochrane tomorrow a further complaint from the committee about the lack of response to our previous complaints. And hoping to find the strength to draft another one soon about the cancellation of the new review and republication of the old one.
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Do take care Trish. I'm already crashing from the limited amount of cognitive stuff I've done today, and your letters are detailed and in depth.
 
Trish said:
Maat quoted this bit:

I responded:

It confused me. I've just checked and can see why. The quote was incomplete. It should have read:

So it seems the going back to the drawing board and reconfiguring the project refers to the preceding sentences about pandemic and restructuring, not to the following sentence about people who tried to stop the project. So there was nothing there we didn't know about already. Hilda's reports had told us about the pandemic and restructuring causing delays and changes.

But there are still big gaps in the story. Who stopped the IAG ever seeing the draft protocol, why was the draft protocol rejected without consulting the IAG, why did that process of not dealing with the protocol take nearly 2 years? And much more.

It's time someone started naming names.
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I wouldn't assume. Non-sequitur is used a lot sometimes deliberately, sometimes inadvertently. Without asking the question these points could be unrelated to each other (ie the reconfigure nothing to do with the sentences before, just 'another thing', or related to the sentence after) or the links between them need to be absolutely clarified as it could go many different ways.

There is a chance even Hilda would not know which is 'the driver/cause'
 
dave30th said:
I tried to make this argument very strongly when I met with David Tovey years ago. I was not able to convince him.
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I think that at some point there is a piece of work to be done on the levels of coercion that are particularly present and directed at pwme in these subjectively-measured experiments. Including gaslighting having been created from so many different angles, and eg reporting back to employers pressures, being seen to not be 'non-compliant' and so on.

Some people would have been left with an actual choice of 'say you are progressing or lose even more of everything today', ie the consequences or perceived threats weren't hidden under which people were giving their answers. There were obvious 'safe/right answers' put into newsletters.

I say pwme because it is a context, so it can be plotted, not because I don't think that this hasn't at least in some ways been multiplied to other conditions too. However 10+ years ago around the time of these trials in particular the punitive, terrifying and evangelical context towards cfs was pretty extreme and isolated them from social support (which is proper psychology then was well-known and written about as the most important determinant of mental health not being significantly harmed and risked - so I find it fascinating how targeted that was by people who were in that specific area to deliberately create isolation and compulsion by threat of alienation if you do not pretend not to be ill etc)

The method is bad enough. That it was combined with these features makes it a different level of issue. It was no longer just a study on measuring 'treatment' but 'nudge' to a level that you are probably looking at other situational-pressure terms.
 
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Thought you might be interested in the cumulative number of signatures on the petition. Dave Tuller asked about numbers, reminding me that I haven't looked at the numbers lately.

We got 1822 signatures since Cochrane announced the abandonment of the new review process, and nearly 300 signatures in the last couple of days. I think we'll pass the 15,000 mark in February.
 
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Trish said:
Hilda Bastian has just posted the following on her talkpage in response to some questions I asked there a few weeks ago.
https://hbprojecttalk.wordpress.com/2024/12/18/brief-message/
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Though I have seen no documentation beyond that I provided myself, I am confident that the investigation did take place. Therefore, you are entitled to be informed of the outcome. I have been pursuing this, and will continue to do so until you get a response. Between my blog post and my personal representations, I think it’s fair to say that my urging of Cochrane for that response to be substantive is forceful. And of course, the same applies to protesting that this happened. I am sorry that I could not get a resolution of this sooner. I have also made clear that I think their new complaints policy has problems, even if it were being followed. I will pursue that as well.

Cochrane owes you an apology.
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It does sound as though Hilda tried hard in 2024 to get Cochrane to act properly, and she seems determined to continue to hold Cochrane to account.
 
Some notes/info related to the petition:

We have 79 organisations supporting the campaign, from 25 countries.

If any of you have connections with the organisations that had IAG representatives, please reach out to them and ask them to consider signing on to the campaign (#MEAction (US); EMEA and some of the national members; ME/CFS Australia and their regional affiliates); IACFSME. We have pretty much all the ME/CFS national organisations in the world on board, the gaps are some affiliated with those IAG-member organisations.

We have two supporter videos showing on the petition page. I don't know how somebody does that - presumably it's an option when a supporter signs the petition? Well done to the two people who not only knew how to do it, but actually did it. I wonder if supporter videos can be added later? Does anyone have experience with that? It would be great to get some more videos there.

We have signatories from 85 countries, with 5 new countries since October 2024:
1 Anguilla
1 Indonesia
1 Moldova
8 Russia
1 Ukraine
 
Well, good for Hilda. I rather expected her to simply turn away, as so many others have done over the years. Given Cochrane's leadership is obviously going to ignore or stonewall any internal complaints I wonder if the IAG would now consider making a complaint to Wiley about both the publication ethics aspects of all this, & in particular the "update" that has allowed Larun to be cited spuriously as a 2024 review?
Jonathan Edwards said:
Gill Leng was on the governing board of Cochrane during this period. Why did she not blow the whistle?
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Interestingly, Leng has a piece in in the BMJ (about her being a chair of a new review into PAs) which has her affiliations listed as a trustee of Cochrane, & also contains this paragraph:
I am not unfamiliar with areas of medical controversy. More than 20 years on the board at the National Institute for Health and Care Excellence (NICE) exposed me to many challenging decisions in areas such as myalgic encephalopathy, fertility treatment, management of depression, and the use of e-cigarettes.
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In most cases it was inherently impossible to please all interested parties, with stakeholders usually including a mixture of professional societies, patient groups, and healthcare providers. The only way to steer a path through arguments and counter arguments was with clarity of approach, basing decisions on evidence and data, listening to all perspectives and excluding those with a conflict of interest.
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Thanks to the committee for all their work on the petition updates.
 
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Nightsong said:
Interestingly, Leng has a piece in in the BMJ (about her being a chair of a new review into PAs) which has her affiliations listed as a trustee of Cochrane
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Interesting that she can write this about the PA review:
I have no preconceived ideas about the outcome of the review, I wouldn’t be a credible chair if I did. I can promise this: it will be based on a fair, open process, with recommendations underpinned by data, research literature, and the broadest forms of evidence.... I ask all those with a personal or professional interest to accept its best intentions.
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Hutan said:
View attachment 25110
Thought you might be interested in the cumulative number of signatures on the petition. Dave Tuller asked about numbers, reminding me that I haven't looked at the numbers lately.

We got 1822 signatures since Cochrane announced the abandonment of the new review process, and nearly 300 signatures in the last couple of days. I think we'll pass the 15,000 mark in February.
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Interesting to see that after the initial burst of signatures the rate of additional ones between approx. Nov 2023 and Nov 2024 was consistent, making up a significant proportion (approx. 20% of the total, at Nov 2024), and showing no sign of slowing. That suggests that word is still slowly spreading, independent of events post-Nov 2024, which is encouraging.
 
If I was not preoccupied this week I might think about a very brief letter to the BMJ basically saying that it is essential that the international medical community has taken note of Hilda Bastian's recent statements and their implications for Cochrane's credibility.

I might get around to it, especially if one or two others wanted to join in.
 
I have just submitted this complaint to Cochrane on behalf of the committee.

In brief, it's a complaint that we have not been informed of the outcome of our previous complaints, contrary to Cochrane's own complaints policy.
This also means we theoretically can't escalate our complaint to the Cochrane appeals process or to COPE or the Charity Commission, since they require evidence that we've made a complaint and the outcome. We've given them 3 weeks to come back with a substantive response or we'll escalate it anyway.

Science For ME said:
Today, 26th January 2025, the S4ME committee submitted the following complaint to Cochrane complaints:
_______________

We, the committee of the Science for ME international forum, submit the following complaint to Cochrane.

The Cochrane review that is the subject of our complaint is Exercise Therapy for Chronic Fatigue Syndrome, Larun et al, 2019 and 2024 versions.

All our letters and complaints, and responses we received from Cochrane are on public record on the Science for ME forum. We will post this complaint there too.
https://www.s4me.info/threads/s4me-...-on-the-me-cfs-exercise-therapy-review.34973/

Complaint January 2025

This complaint is on the basis of a perceived failure of Cochrane to follow its own complaints procedure in investigating our previous complaints and failing to inform us of the outcome.

Promises made to us in communications from senior Cochrane representatives with regard to investigation of our complaints have not been fulfilled. We have not been informed of the outcome of any of our complaints, nor which of our complaints were investigated and which were not.

The details are set out below:

30th October 2023
Following some correspondence with Cochrane starting in August 2023 in which we asked for the review to be withdrawn, we sent a letter of complaint detailing the following five complaints:

Complaint A: A failure of process - non removal of an outdated and incorrect review in the timescale promised.
Complaint B: A failure of process - failure to follow normal procedure on a critical comment
Complaint C: A failure of process - failure to take effective action for over two years by the Editor-in-Chief on the stalled new review process.
Complaint D: A failure of process - the Editor-in-Chief's failure to address serious concerns from the public, and passing them, inappropriately, to the IAG that has no power to act on our requests, and has a non functioning email address.
Complaint E: An important policy misjudgement - making the withdrawal of the 2019 review contingent on the publication of a new review.

https://www.s4me.info/threads/s4me-...fs-exercise-therapy-review.34973/#post-501221

Correspondence November, December 2023
There followed some correspondence due to confusions at Cochrane about our complaints.
13/11/23: Lucy Johnson-Brown, Head of Governance, confused our complaints with a previous one by a person and on a topic unknown to us.
17/11/23: A reply from us pointing out the misunderstanding and asking for our complaint to be considered properly.
17/11/23: Lucy Johnson-Brown sent a further refusal to consider our complaints while also stating commitment to follow the complaints procedure.
20/11/23: We replied expressing shock that our complaints did not appear to be getting due consideration unlike those of others with opposing complaints. We asked for confirmation that the trustees had signed of on this decision not to follow the complaints procedure.
19/12/23: Jordi Pardo Pardo, interim chair of governors, stated, without reasons that withdrawal of the 2019 review had already been rejected following a previous complaint on unspecified grounds.
He concluded:
"However, the other matters you have raised are under review, and we will get back to you in due course."

17th March 2024
The Science for ME committee, concerned about the lack of communication and action on the new review, wrote again to senior Cochrane representatives. We asked them to reconsider their decision not to withdraw the 2019 review. We set out, with details and references, evidence under the following headings for withdrawal of the review on the grounds of harm:
Evidence in support of withdrawal
1. Withdrawal of the review is in line with Cochrane's editorial policy
2. Cochrane's guidance to reviewers has not been followed
3.The 2019 review failed to properly consider evidence of harms.
4. Patients' perceptions of harm should be considered as relevant as patients' perceptions of improvement
5. The harms are considerable
6. New evidence of harms supports withdrawal
7. Two conflicting paradigms
8. The harms include effects on patients’ mental health
9. Biases and conflicts of interest of advisors to the review
10. The NICE approach to harms evidence, and the pushback from GET supporters

https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-2#post-521800

April 2024
9/4/24: Cochrane support replied, saying
"We will include the additional points and references to studies in our review of the issues raised by S4ME in previous correspondence."

August 2024
7/8/24: We wrote to Cochrane raising the long silence and lack of information about which of our complaints are being considered, and asking:
"Please can you confirm that the 2019 review is being considered for withdrawal on the grounds that Following the conclusions of the published review could result in harm to patients or populations of interest (other than known adverse effects)?"
We also stated that:
"In our view, it is completely unacceptable for Cochrane, a registered charity whose charitable object is "the protection and preservation of public health..", to deprioritise work affecting the health of millions of very sick people, leaving us vulnerable to harmful treatment for years after promising to update a seriously flawed review."
7/8/24: Cochrane complaints acknowleded our complaint in a standard response.
21/8/24 and 27/9/24: Cochrane complaints - "we are still investigating and we will update you as soon as we can."

December 2024
16/12/24 Cochrane announced cancellation of the new review process. Cochrane republished the 2019 review unchanged as a new 2024 version.
____________

It is clear from the above that Cochrane has not followed its complaints procedure with regard to our complaints.

We have no information about whether a complaints process was ever started or which of our complaints were intended to be considered. Nor have we been informed whether the senior editors took seriously or even read the detailed and fully referenced information we supplied that we consider fulfil Cochrane's own rules on withdrawal of reviews on the grounds of harm.

None of the promises to keep us updated have been fulfilled, nor have we been supplied with a copy of the outcome of the review of our complaints.
________________

This lack of a response leaves us, according to your complaints procedure, unable to escalate our complaint through the appeals board since we don't have a ruling, nor to Cope and the Charity Commission. This is unacceptable.

Please can you supply us urgently with answers to the following questions:

1. Did Cochrane complaints carry out a complaints review procedure into our complaints dated 30th October 2023?
If so, please inform us of which complaints were reviewed and the outcomes.
If not, please explain why you left our complaints unaddressed for over a year, and failed to inform us.

2. Did Cochrane complaints and the relevant editors carry out a proper examination of the evidence on harms we supplied on 17th March 2024?
If so, please supply us with the outcome explaining why Cochrane editors did not consider the evidence grounds for withdrawal according to Cochrane's policy on withdrawal on the basis of harms.
If not, why not, when we were promised it would be included in the review of our complaints.
______________

We intend to take this complaint further. Cochrane has an obligation under your own policies to inform us of the outcome of our complaints, especially as we are required to provide such a ruling in taking our complaint to appeal and to COPE and the Charity Commission.
https://community.cochrane.org/orga...l-members-and-supporters/complaints-procedure

If we do not get a response with clearly explained rulings on all our complaints by 14th February 2025, we will escalate the complaint anyway, adding a further complaint of Cochrane's refusal to carry out your own complaints process and inform us of the outcomes.
______________

Trish Davis on behalf of the committee of the Science for ME international forum
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Jonathan Edwards said:
If I was not preoccupied this week I might think about a very brief letter to the BMJ basically saying that it is essential that the international medical community has taken note of Hilda Bastian's recent statements and their implications for Cochrane's credibility.

I might get around to it, especially if one or two others wanted to join in.
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I hope you will, because Cochrane are doing an outstanding job of not listening to patients.
 
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