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

[Midnattsol]

I got the more recent emails (June 2019) between Cochrane and Norwegian Institute of Public Health via a FOI to NIPH. But I imagine they stopped correspondence after the agreement was made that they would publish the review.

In the Lightning Process ethical review case, we saw one of the FHI/NIPH employee's who has been outspoken in favor of lightning process use her personal email address when contacting member of the ethical board, that would not have shown up in an FOI of NIPH.

 

[Arvo]

We had to go back to the drawing board to re-configure this project a couple of times. Advocates of the intervention .

I missed that bit. I must read it again more carefully.
I wish she'd name them.
Well, they clearly succeeded in stopping the project in the end.

For me this actually was one of the things that stood out, the clear and open statement that this was indeed going on behind the scenes, that these people were a hinderance to executing the project, and they did that by way of launching "a full-on bid to try to stop the project".

I hope confirmations on who these people were exactly will be disclosed as well, it matters for accountability. Who launched a full-on bid to try to stop the project?

I think Cochrane is being really, really stupid with this. Their whole existence hinges on being a reliable summarizer of available evidence, that's what they do ("Trusted evidence. Informed decisions. Better health.") The ME/CFS project and the mask study can make big, irreparable tears in that sense of reliability as it shows that they do not always uphold their claims, on big issues. And once they lose that, it will be nearly impossible to get back.

 

[Caroline Struthers]

I wonder whether there is more correspondence now about the republishing as a 2024 review, which presumably Larun had to agree to, as lead author.

You're right. And it explains why Larun has started responding to comments again. I will put in another FOI request to NIPH for correspondence between anyone there and Cochrane from June 2019 to now.

 

[Trish]

To clarify, I knew because Hilda put it in one of her published updates that there had been a complaint that wanted the new review process stopped and took a year for Cochrane to decide on, during which the IAG were told to stop work, but the author group were allowed to continue. But i thought the only changes made for 'balance' were that the IAG were told to add a person who had recovered from ME/CFS and a doctor who treats ME/CFS.

I hadn't taken in the implications, whatever they were, of having to reconfigure the whole project several times. That implies to me that there was ongoing pressure on senior Cochrane people, and may, though Hilda doesn't say it, have finally killed the project.

 

[Peter T]

To clarify, I knew because Hilda put it in one of her published updates that there had been a complaint that wanted the new review process stopped and took a year for Cochrane to decide on, during which the IAG were told to stop work, but the author group were allowed to continue. But i thought the only changes made for 'balance' were that the IAG were told to add a person who had recovered from ME/CFS and a doctor who treats ME/CFS.

I hadn't taken in the implications, whatever they were, of having to reconfigure the whole project several times. That implies to me that there was ongoing pressure on senior Cochrane people, and may, though Hilda doesn't say it, have finally killed the project.

If I feel up to it I will try to look back over Hilda’s blog posts as at that time she was playing the sophist to avoid writing anything directly critical of Cochrane and in response to my comment(s) seemingly denied that there were any complaints about the new review process that caused a delay. It may be that between what she said and what she denied there are further clues about what happened.

 

[rvallee]

I missed that bit. I must read it again more carefully.
I wish she'd name them.
Well, they clearly succeeded in stopping the project in the end.

Must be, or at least include, the complaint we heard had derailed things for more than a year. Because Cochrane only takes some complaints seriously, in a completely biased way.

 

[rvallee]

I have never been good at identifying people's motives for doing certain things. But I think I missed a really obvious and important motive when it was discovered that the Larun paper was re-dated to 2024 just for adding a single Editorial Note.

It must have been to make it appear that the Larun paper was newer than the latest NICE Guidelines of 2021, so that people who aren't careful in their reading will assume that the NICE Guidelines have been superseded.

I'm sure I'm just re-stating what others have said in this thread already, but it has only just sunk in.

Oh, for sure. That and the recent flawed "living review" that is entirely dependent on a single trial for which they misapplied the findings. But also no one will bother checking that. And we can point it out and no one who wants this bag of lies to be true will mind. And that's why they keep doing the same identical trials and useless studies. This way everything they do can get debunked and it doesn't matter because by the time it's been debunked they'll have more 'newer' evidence.

Because evidence is irrelevant in evidence-based medicine. And Cochrane is a primary offender of this corruption, this is why they can't let this go. They can't ever cede one bit of ground, endless production of the same BS is the formula they abuse.

 

[Trish]

Maat quoted this bit:

We had to go back to the drawing board to re-configure this project a couple of times. Advocates of the intervention launched a full-on bid to try to stop the project.

I responded:

I missed that bit. I must read it again more carefully.
I wish she'd name them.
Well, they clearly succeeded in stopping the project in the end.

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

The project was supposed to take two years, starting in 2020. But then came the pandemic, and Cochrane turned a major amount of its attention to that. The organization took a major hit in funding and restructured, with massive implications. We had to go back to the drawing board to re-configure this project a couple of times. Advocates of the intervention launched a full-on bid to try to stop the project.

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.

 

[Trish]

If anyone wants to check, Hilda's updates are archived here:
https://web.archive.org/web/2024041...eholder-engagement-high-profile-reviews-pilot

 

[dave30th]

I wonder if there are people in Cochrane who understand this, who understand that if the profound problems with the trial design recipe of only subjective outcomes in unblinded trials were to be recognised, it would show that many of the treatments that Cochrane has endorsed for years and that friends have built their careers on are ineffective.

I tried to make this argument very strongly when I met with David Tovey years ago. I was not able to convince him.

 

[Maat]

Basic question from a non science background.

Does Cochrane have an ethics committee, and are the systematic reviews considered 'research' on human subjects for the purposes of the Declaration of Helsinki (both the 2013 and 13 December 2024 versions?) I'm guessing it does because a protocol was being developed, although the IAG never appears to have seen it.

The reason I ask is because this appears in the new 2024 DoH in the role and function of Ethics Committees section. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Participants – WMA – The World Medical Association

Section 23

The committee must have sufficient familiarity with local circumstances and context, and include at least one member of the general public. It must take into consideration the ethical, legal, and regulatory norms and standards of the country or countries in which the research is to be performed as well as applicable international norms and standards, but these must not be allowed to reduce or eliminate any of the protections for research participants set forth in this Declaration.
When collaborative research is performed internationally, the research protocol must be approved by research ethics committees in both the sponsoring and host countries.

The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research. Where monitoring is required, the researcher must provide information to the committee and/or competent data and safety monitoring entity, especially about any serious adverse events.

By suspending, as they did days after the publications of the new DoH, they don't have to monitor. The Reg 28 PFD report would be relevant in this context.

The advocates of therapies, bearing in mind the 'anomalies' opinion piece in July 2023 can then continue to argue on the ground of 'risks this against the 2021 NICE Guideline

Sections 17 and 18

All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures to minimize the risks and burdens must be implemented. The risks and burdens must be continuously monitored, assessed, and documented by the researcher.
Physicians and other researchers may not engage in research involving human participants unless they are confident that the risks and burdens have been adequately assessed and can be satisfactorily managed.

When the risks and burdens are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians and other researchers must assess whether to continue, modify or immediately stop the research.

Feel free to demolish the relevance of this argument, because I am looking at it from a legal definitions mindset.

ETA: This also ties in with the decision to include reference to FND diagnosis overlay in the UK healthcare professionals training module produced under the ME/CFS Delivery plan, publshed Jan 2025

 

[dave30th]

The writing group finished its draft and gave it to the Editorial Group

apparently there were several rounds, so Cochrane did provide responses to early drafts of the protocol. Just they didn't respond to the last draft, which was sent in almost 2 years ago now.

 

[dave30th]

One thing that's glaringly obvious but neither Cochrane nor Hilda are wiliing to say is that there is clearly behind the scenes influence going on at Cochrane to preserve a review recommending exercise therapy for ME/CFS at all costs.

I tweeted or rather BlueSkyed something along these lines. Hilda responded: "Big question. An answer wouldn't fit in this little box."

Pehaps more will be revealed in time.

 

[Trish]

Does Cochrane have an ethics committee, and are the systematic reviews considered 'research' on human subjects for the purposes of the Declaration of Helsinki (both the 2013 and 13 December 2024 versions?)

Cochrane doesn't do research on human subjects. It does systematic reviews of other people's published research. Therefore I can't see why they would have an ethics committee.

 

[Maat]

Cochrane doesn't do research on human subjects. It does systematic reviews of other people's published research. Therefore I can't see why they would have an ethics committee.

But, am I correct in understanding they can withdraw entire reviews, or exclude certain pieces of research from a review, on various grounds which relate to patient safety and they are required to write a protocol, and protocols are very specifically detailed in the DoH?

 

[Trish]

As I understand it their protocols are about what sort of studies they will include, what they are going to use as the primary and secondary outcome measures, how the data from the studies will be combined and analysed etc. In other words it's a paper and mathematical exercise, not one that involves patients.
I'm not an expert on how the Declaration of Helsinki does or doesn't apply to Cochrane reviews.

 

[Maat]

and I'm sure I read somewhere that they adhered to COPE Publication ethics: An introduction to COPE

Retracting an article when an institutional review concludes no misconduct | COPE: Committee on Publication Ethics

 

[Trish]

Yes they are under COPE's rules.

 

[Peter T]

Cochrane doesn't do research on human subjects. It does systematic reviews of other people's published research. Therefore I can't see why they would have an ethics committee.

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?

 

[Maat]

and I'm sure I read somewhere that they adhered to COPE Publication ethics: An introduction to COPE

Retracting an article when an institutional review concludes no misconduct | COPE: Committee on Publication Ethics

From the Editor's note published 2 October 2019

Cochrane’s Editor-in-Chief, Dr Karla Soares-Weiser, commented on the publication of the review, “Cochrane recognizes the importance of providing the best available evidence on interventions for ME/CFS to enable patients and clinicians across the world to make well-informed decisions about treatment. This amended review is still based on a research question and a set of methods from 2002, and reflects evidence from studies that applied definitions of ME/CFS from the 1990s. Having heard different views expressed about the evidence base for this condition, we acknowledge that the publication of this amended review will not resolve all the ongoing questions about this globally important health topic.

“We have decided, therefore, that a new approach to the publication of evidence in this area is needed; and, today we are committing to the production of a full update of this Cochrane Review, beginning with a comprehensive review of the protocol, which will be developed in consultation with an independent advisory group that we intend to convene. This group will involve partners from patient-advocacy groups from different parts of the world who will help us to embed a patient-focused, contemporary perspective on the review question, methods and findings.”

In Hilda's latest blog she mentions over 100 criticisms received.