Petition: S4ME 2023 - Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review

Hutan · Feb 21, 2024

Thanks @Andy, fixed

NelliePledge · Feb 21, 2024

Andy said: ↑

Action for ME Twitter account report that
"The APPG has agreed to sign the S4ME open letter to Cochrane requesting urgent action to be taken on the 2019 ME/CFS Exercise Therapy Review"
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Thanks to the APPG who have been added to the list of signatory groups/organisations, now standing at 70.

Ash · Feb 21, 2024

Fine work everyone who got us to 70!!!

Joan Crawford · Feb 22, 2024

Hi,

I've had a look at group signatures and I cannot see the Chester MESH self help group.

Can this organisation be added please?

Can you let me know the procedure for groups and organisations to sign and I can share.

Many thanks
Joan

NelliePledge · Feb 22, 2024

Hi @Joan Crawford. We did contact a lot of UK groups through ME Local which is included in signatory list not sure if that includes Chester? But we’ve also got groups that signed up in their own name. Happy to add Chester to the list based on your request nothing further needed.

Trish · Feb 22, 2024

To add signatures organisations can contact us by email moderators@s4me.info

Joan Crawford · Feb 22, 2024

NelliePledge said: ↑

Hi @Joan Crawford. We did contact a lot of UK groups through ME Local which is included in signatory list not sure if that includes Chester? But we’ve also got groups that signed up in their own name. Happy to add Chester to the list based on your request nothing further needed.
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Fab thanks

The name is:

Chester MESH self help group

Many thanks
Joan

NelliePledge · Feb 22, 2024

Thanks @Joan Crawford ive added Chester to the signatory list.

Andy · Mar 4, 2024

Current total is 10,563

https://www.change.org/p/cochrane-withdraw-the-harmful-2019-exercise-therapy-for-cfs-review

Andy · Mar 16, 2024

Current total is 10,578

https://www.change.org/p/cochrane-withdraw-the-harmful-2019-exercise-therapy-for-cfs-review

Trish · Mar 18, 2024

The committee has sent a new letter to key people at Cochrane, posted on the letter thread:
https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-2#post-521800
It's quite long, so I'll summarise it in the next post.

Science For ME said: ↑

On 17th March 2024 the Science for ME Committee sent the following:

To
Jordi Pardo Pardo - Interim Chair of the Cochrane Governing Board
Karla Soares-Weisser, Cochrane Editor in Chief
Vanessa Jordan, Chair - Cochrane's Conflict of Interest Committee

Subject: Exercise therapy for ME/CFS

Dear Jordi Pardo Pardo, Karla Soares-Weisser and Vanessa Jordan,

Six months ago we wrote to the Editor-in-Chief (August 2023) regarding the 2019 Cochrane review: Exercise therapy for chronic fatigue syndrome by Larun et al. (Larun, 2019) Since then no progress has been made on the new review and older versions remain. It is clear that our request that the new review be published within a year of our initial letter will not be achieved.

We repeat our great concern that while the 2019 review is in place and continuing to be cited, interventions are being promoted that have been shown not only as ineffective (Wilshire, 2018), but also to cause serious harm to patients.

We are writing to you today to ask you to reopen consideration of withdrawal of the 2019 review as a matter of urgency, on the grounds of increasing and compelling evidence of harm to both the physical and mental health of patients, as we set out in the following section.

We formally present to the Cochrane board and editors our request, supported now by 70 organisations worldwide, listed below, and 10,500 individuals from 24 countries who have signed our petition, Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review (Petition, 2023).

Over 500 people have added comments to our petition. Many report that they or their loved ones are suffering serious and lasting deterioration directly attributable to Graded Exercise Therapy (GET). Some people have lost mobility or the ability to work, some need to use a wheelchair. Some have become housebound and even bedridden for years. The petition comments are addressed to Cochrane. We hope you will read them.

We do not think that Cochrane would tolerate such a delay in withdrawing a review relating to a pharmaceutical intervention that had been shown to be ineffective and cause harm. We fail to understand why a behavioural approach, pushing patients to damage themselves, should be treated differently. For very good reasons the harms standard has a lower bar for triggering precautionary action. It does not require the same level of robust evidence as claims of benefit do, only a significant plausible concern, which standard is easily met in this case by available evidence.

Cochrane editors, in going along with the recommendation of exercise therapy on the basis of short term subjective outcomes on unblinded trials, with multiple flaws as spelled out by Tack in 2020 do a disservice to people with ME/CFS and to science. That Larun et al, advised by people with serious conflicts of interest, failed to investigate the validity of harms data in the PACE trial, and failed to follow Cochrane's guidance on seeking wider evidence of adverse events, makes the review unsafe.

We therefore conclude by repeating our request that Cochrane follow its own editorial policy on withdrawing reviews on the basis that:

Following the conclusions of the published review could result in harm to patients or populations of interest.

We trust you will give urgent attention to this serious matter and reach a rapid decision in line with Cochrane's own policy and charitable purpose and in the interests of patient welfare and sound science.

Thank you for your consideration of our request. We would draw your attention to the points below in support of withdrawal of the review.

Yours sincerely,

Trish Davis on behalf of the committee of Science for ME
__________________

Evidence in support of withdrawal

1. Withdrawal of the review is in line with Cochrane's editorial policy

Cochrane Reviews are withdrawn when serious issues with conduct or reporting are identified. The 2019 review meets the conditions for withdrawal of the review on the grounds, both that there are "factual errors in describing one or more included studies that risk misinforming implementation or investment decisions about an intervention" and that "Following the conclusions of the published review could result in harm to patients or populations of interest (other than known adverse effects)."
(Cochrane's editorial policy: Withdrawal of published articles)

2. Cochrane's guidance to reviewers has not been followed

The 2019 review places adverse events in a key position as one of two primary outcomes. However, the reviewers made the narrowest possible interpretation of this, including only data from one trial. This is contrary to the Cochrane handbook which specifies a more detailed analysis of adverse effects in cases such as this where the potential for harm has a major influence on treatment and policy decisions. In such cases it is expected that a bespoke search process will be undertaken that includes a wider selection of sources than that required to identify data on beneficial outcomes. (Cochrane Handbook for reviewers Chapter 19 - Adverse events)

3.The 2019 review failed to properly consider evidence of harms.

The 2019 review did not analyse fully the data on harms of the largest trial, the only one to collect such data, the PACE trial (White et al, 2011). The review relied instead on the PACE researchers’ own analysis and conclusions. Analysis of individual patient data (Vink, 2017) shows very high levels of deterioration in the PACE participants who underwent graded exercise therapy. Yet the PACE trial reported only two serious adverse outcomes in the GET group and Larun et al accepted that conclusion without question. There were also higher drop out rates and deterioration in GET groups than control groups in other trials (Vink, 2017; Vink, 2018).

All analyses, Kindlon (2011 and 2017), Geraghty (2017) and Kirke (2017), of survey data were omitted. Large scale surveys have consistently found deterioration in participants’ health, often reporting being very much worse, after GET even when done under the supervision of specialist therapists. It seems that Larun et al accepted the PACE triallists incorrect claim that survey data showing harms was not based on specialist treatment. (Kirke, 2017)

4. Patients' perceptions of harm should be considered as relevant as patients' perceptions of improvement

GET is justified on the basis that, regardless of a lack of any objective improvement in physical capability, the inducing of a positive change in the patient's perception of their ability to tolerate exertion is a useful outcome. Proponents of GET have accepted patients' subjective reports of, usually short term, improvement as evidence of the success of the treatment. To be consistent, those that hold that view must equally allow that reporting by patients of a seriously negative change in their ability to tolerate exertion while receiving GET is a failure of the treatment. A large number of patients have reported a seriously negative change in their perceived ability to tolerate exertion after GET (Edwards (2021).

5. The harms are considerable

PACE participants who underwent graded exercise therapy showed very high levels of deterioration: of the 160 people in the GET group, all able to complete the 6-minute walk test at the start of the trial, 22 did worse at 52 weeks, and 49 either refused or were not able to do the walk test at 52 weeks. (Vink, 2017)

Surveys and patients' testimony report that harm from GET is common, is severe, and can be long lasting, with some becoming housebound or bedbound for years, suffering pain, severe debility, extreme sensory sensitivities, cognitive dysfunction, orthostatic intolerance and multiple other symptoms affecting many parts of the body. Patients' severity level can go from mild to severe following a short course of therapist led GET.

It is important for decision makers at Cochrane to understand that harm in ME/CFS is not just short term discomfort, nor is it the result of non-expert treatment, as the supporters of exercise therapy contend. Neither is it just relevant to people with severe ME/CFS. Indeed as surveys show, many who start treatment with mild ME/CFS become severe.

6. New evidence of harms supports withdrawal

Since the 2019 review was published, further evidence has become available, including a survey carried out in the UK over three weeks in early 2019 to help inform the NICE evidence review. It reported on over 2000 people's experience of CBT and GET, mostly provided by NHS specialist clinicians since the 2007 NICE guideline recommended these interventions.

With GET on its own, the majority of responders reported not completing the course (61%), of those that started the course 81% reporting worsening of symptoms. Approximately seventy nine percent of people reported no improvement (11.7%) or deterioration (67.1%) in physical health [18.5% minor deterioration, 48.6% major deterioration]. 79% of people reported that GET led to no change (25.5%) or worsening (53% ) of mental health after GET... 86% of responders reported that GET, when combined with CBT, had worsened their symptoms. (OxCATTS, 2019).

The report includes short quotes from patients describing the nature of worsening. Many reported long term deterioration and additional symptoms such as pain that they had not experienced before GET. Severity levels before and after treatment were reported. The percentage with severe ME/CFS increased after GET.

A recent paediatric trial found not only that GET was ineffective, but reported evidence of deterioration in 27% of the participants in the GET group who remained in the study at followup. (Gaunt et al, 2024)

7. Two conflicting paradigms

Cochrane editors should be aware that the supporters of the psychosomatic model of ME/CFS and who are proponents of CBT and exercise therapy for CFS are a minority of the medical profession. GET is based on the unevidenced hypothesis that "CFS/ME is perpetuated by deconditioning, reduced physical strength and altered perception of effort consequent upon reduced physical activity". (PACE GET Manual for Therapists, Bavington, White et al.).

Many other academics and clinicians researching and caring for people with ME/CFS, including psychology professor, Brian Hughes, recognise the failure of the psychosomatic paradigm and the CBT/GET approach to treatment. Far from being a few disgruntled patients and misguided patient organisations opposing these treatments, most scientists currently studying ME/CFS recognise that there are biological factors that make people who experience Post-exertional Malaise (PEM), the core defining feature of ME/CFS, sicker as a direct result of exertion beyond their already very limited capacity. (Keller 2014, Moore 2023). This means that GET is contraindicated for people diagnosed using current diagnostic criteria that require PEM.

8. The harms include effects on patients’ mental health

The harm caused by GET is not simply physical deterioration. GET is based in the psychosomatic paradigm, with the assumption that people can be well if they overcome their fear of activity and over-sensitivity to symptoms. This creates a serious disconnect and a loss of trust between the health professionals and the patients who are not able to improve despite following exercise or activity schedules under the guidance of specialist therapists.

In the survey described above, 53% reported worsening mental health following GET prescribed by UK specialist clinics. (OxCATTS, 2019).

König et al found that a third of the ME/CFS patients in their survey had experienced suicidal thoughts, and that a main factor contributing to suicidal thoughts, reported by 90% of those who had had them, was being told that the disease was only psychosomatic. (König et al)

In a GET trial, Gaunt et al report that there was one hospital admission of a child due to suicidal ideation that the authors acknowledged was possibly due to GET. (Gaunt et al)

9. Biases and conflicts of interest of advisors to the review

There are reasonable concerns that harms may have been underplayed or overlooked because of unbalanced advice to the 2019 Larun et al review.

The Larun authors include Jonathan Price who had a previously stated position on ‘medically unexplained physical symptoms’.

Peter White is listed as an advisor to the review. Both Peter White and Michael Sharpe, a long term departmental colleague of Price, were lead authors on the PACE trial. As well as an obvious interest in defending the trial paper’s disregard of data on harms, White has reputational and financial interests in the supposed safety and efficacy of GET. He has for many years acted as a paid advisor to a reinsurance company in whose interest it is that ME/CFS be classed as psychosomatic and amenable to CBT/GET treatment, as this limits disability payouts. Sharpe and White's conflicts of interest were not declared as they should have been in the consent process for PACE participants. Geraghty, 2017 addresses conflicts of interest and Lubet, 2017 highlights reasons for the particularly high risk of investigator bias in PACE.

The second advisor to the 2019 review, Paul Glasziou, had published papers supporting exercise interventions for ME/CFS (Glasziou, 2019).

There was no one who took part in the review or advised on it who takes a more critical view of GET. There was an obvious lack of openness to the possibility that GET could be ineffective and harmful, and this could plausibly have led to a minimization of the potential for harms.

10. The NICE approach to harms evidence, and the pushback from GET supporters

In October 2021 NICE published a new ME/CFS guideline. The accompanying evidence review included both efficacy and harms data analysis. The conclusion was to recommend against GET. Since publication, clinicians supporting GET, including White, Sharpe and Wessely with their ongoing conflicts of interest, Paul Glasziou, who, along with White, is listed as an advisor to the 2019 Larun review, and Cochrane's Paul Garner, have been conducting a campaign against the NICE findings against GET. However, their claims have been shown to be groundless (Hughes, 2023), (Barry et al, 2024).

In their section on harms data used by NICE, Barry (Barry et al, 2024), explains the importance of evidence reviews including qualitative and survey evidence on harms which were found to be 'by some accounts quite devastating'.
_________________

The letter concluded with the list of 70 organisations supporting our requests to Cochrane.
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Trish · Mar 18, 2024

Summary of the latest S4ME letter to Cochrane:

We mark the fact that it's 6 months since we first wrote to Cochrane and no action has been taken on our requests, and no progress has been made on the new review.

We formally present the petition to Cochrane and encourage them to read the comments on it.

We request that the decision not to withdraw the 2019 Larun review be reopened urgently on the grounds of harm.

We give 10 grounds related to the harms caused by GET for the review to be withdrawn, under these headings:

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
_________________

The letter is signed by me and the committee. Although I drafted and edited the letter, several committee members and staff helped with additional suggestions and improvements, for which I thank them.

Peter Trewhitt · Mar 18, 2024

Trish said: ↑

Summary of the latest S4ME letter to Cochrane:

We mark the fact that it's 6 months since we first wrote to Cochrane and no action has been taken on our requests, and no progress has been made on the new review.

We formally present the petition to Cochrane and encourage them to read the comments on it.

We request that the decision not to withdraw the 2019 Larun review be reopened urgently on the grounds of harm.

We give 10 grounds related to the harms caused by GET for the review to be withdrawn, under these headings:

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
_________________

The letter is signed by me and the committee. Although I drafted and edited the letter, several committee members and staff helped with additional suggestions and improvements, for which I thank them.
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Thank you @Trish and all involved for all the work gone into this letter. It is hard to see how anyone with a modicum of sense could continue to ignore these points.

One can only conclude that Cochrane management are now deliberately avoiding any meaningful consideration of these issues, placing their reliance on a small number of pro GET activists, some with very close links to Cochrane, over and above any pretence of scientific balance.

Caroline Struthers · Mar 18, 2024

Peter Trewhitt said: ↑

anyone with a modicum of sense
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seemingly in short supply @ Cochrane Towers!

Hutan · Mar 21, 2024

An update about our most recent letter to Cochrane has been posted on the petition - the update looks a lot like Trish's summary above.

If you haven't had a look at the petition yet, please do. Here's the link: https://chng.it/xwQ9bGgcdL

SNT Gatchaman · Mar 23, 2024

Related to ongoing harms from uncorrected guidance: the UK Covid enquiry is hearing from families of those with eg intellectual disabilities who were denied ICU care and died in the early stages of the pandemic. Thousands of disabled people died after ‘Covid treatment withheld’, inquiry to probe (iNews)

On 20 March 2020, as the Covid crisis was accelerating in hospitals, the NHS watchdog NICE (the National Institute for Health and Care Excellence) issued guidance for trusts and hospitals advising them to apply a “clinical frailty scale” to decide whether patients should be admitted to intensive care.

Older and more frail patients were viewed as being less likely to survive even with critical care treatment.

But according to the learning disability charity Mencap, the original NICE guidance also suggested that those who could not do everyday tasks like cooking, managing money and personal care independently – which are common for people with a learning disability, but who might be otherwise healthy – would be considered frail and as a result might not receive intensive care treatment.
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Mencap complained to NICE and the watchdog revised its guidance in April 2020 to “make clear that the clinical frailty scale should never be used to assess patients aged under 65 or patients of any age with stable long-term disabilities, for example cerebral palsy, learning disabilities or autism”, the charity said.

But in a report published later in 2020, Mencap said: “The original NICE guidance had ongoing damaging consequences.

“By the time clarification to the Clinical Frailty Scale was sent out, it came to Mencap’s attention that many perfectly healthy individuals received letters from their GPs recommending they think carefully about whether they would want resuscitation if they went into hospital or would even want to be treated in hospital at all, should they get Covid-19.”
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Andy · Mar 24, 2024

Current total is 10,598

https://www.change.org/p/cochrane-withdraw-the-harmful-2019-exercise-therapy-for-cfs-review

Maat · Mar 25, 2024

Question:

Does anyone know if NICE issued a statement concerning the possibility of harm resulting from treatment of ME between this specific date parameter?

24.1.2019 - 2.10.2019

The end date being the date Cochrane published the amended version of the Review. Publication of Cochrane Review: ‘Exercise therapy for chronic fatigue syndrome’ | Cochrane

If they did, can someone point me in the direction of a link to it please?

ETA: Also, what is the average timeframe from decision to conduct a review and it's publication?

Peter Trewhitt · Apr 10, 2024

Maat said: ↑

ETA: Also, what is the average timeframe from decision to conduct a review and it's publication?
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There is a recent research paper that looks at this question that has a thread here. I will try to find it, but I have specific problems in coping with how larger amounts of information are structured.

[added - I found the link more easily than expected - https://www.s4me.info/threads/half-...after-the-protocol-2020-andersen-et-al.37474/ “Half of Cochrane reviews were published more than 2 years after the protocol, 2020, Andersen et al.” ]

Peter Trewhitt · Apr 10, 2024

Peter Trewhitt said: ↑

There is a recent research paper that looks at this question that has a thread here. I will try to find it, but I have specific problems in coping with how larger amounts of information are structured.

[added - I found the link more easily than expected - https://www.s4me.info/threads/half-...after-the-protocol-2020-andersen-et-al.37474/ “Half of Cochrane reviews were published more than 2 years after the protocol, 2020, Andersen et al.” ]
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Sorry, although the thread here was recent, the article itself is from 2020. See https://www.jclinepi.com/article/S0895-4356(20)30124-4/abstract . I haven’t yet found access to the full text that is not behind a paywall.

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Petition: S4ME 2023 - Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review

Hutan Moderator Staff Member

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Petition: S4ME 2023 - Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review

Hutan Moderator Staff Member

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Ash Senior Member (Voting Rights)

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NelliePledge Moderator Staff Member

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Joan Crawford Senior Member (Voting Rights)

NelliePledge Moderator Staff Member

Andy Committee Member

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Hutan Moderator Staff Member

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