S4ME: 2023 Open Letter to Cochrane - request for action on the ME/CFS Exercise Therapy Review

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  1. Science For ME

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    PETITION UPDATE

    News from Cochrane, or rather from the Independent Advisory Group

    NOV 12, 2023 —

    Silence has been broken after a hiatus of more than two years in the promised monthly updates from Hilda Bastian, leader of the Independent Advisory Group (IAG) for the process to develop a review to replace the 2019 Larun et al Review.

    You can read the IAG November 2023 update here.
    It includes a new way of making public comments moderated by Hilda Bastian - link here.

    Assessing progress against the requests we made in August 2023:

    1. The immediate withdrawal or retraction of the 2019 Cochrane review 'Exercise therapy for chronic fatigue syndrome’ by Larun et al. and all earlier versions.

    There is no indication that this will happen. Instead, the IAG is drafting a note to be added to the review to reduce 'misinterpretation' and better 'reflect critical nuance and limitations in its conclusions'.

    We are concerned that this description of the problem misses the point that the review is fundamentally flawed. The problem is not just 'nuances' or with readers misinterpreting what the 2019 review says. The authors failed to understand the substantial bias created by the research methodology of the included studies. The most fundamental flaw that makes the review's conclusions unsound is that small improvements in self-reported assessments of symptoms in unblinded trials of treatments that specifically aim to make people downplay their symptoms are not evidence of the treatment working.

    Also describing the problem with the review as being the 'limited applicability' of its conclusions misses the point that when conclusions are not based on good evidence they should not be applied to any patients. Restricting the use of the review to a particular subset of people does not fix the problem.

    A note that says anything less clear than "This review is fundamentally flawed. Do not use it for clinical guidance" in large letters will not fix the problems with the review.

    2. An immediate restart of regular monthly updates on the new review process, with clearly stated timelines for completion of the review to publication within one year from now OR Abandonment of the new review process.

    We welcome the November 2023 update and thank those who are working towards an accurate review. However, 'one swallow does not make a summer'; one update does not make a functioning process that will produce an accurate review in a timely way. There is, as yet, no evidence that Cochrane understands the key problem with the 2019 review, and therefore no evidence that any replacement review will adequately address it. There is no evidence that Cochrane appreciates the urgency of the need for change.

    It is also clear that people in favour of the old review are vigorously opposing change. Explanations for the two year silence include a lengthy process of dealing confidentially with several complaints, none of which were upheld. One complaint from supporters of exercise therapy for ME/CFS opposing the new review process seems to have taken around a year and the consideration of multiple committees within Cochrane to address.
    ________________



    So, four years after a process to replace the 2019 review started, it remains in place, and any replacement review is still some way off. More scarce health resources have been wasted delivering treatments that do not work and more people have been harmed. Crucially, more research with the same fundamental flaws that are ignored in the 2019 review - some on CFS, some on Long Covid and some on various "functional" diagnoses - has been funded and done, with the results going on to mis-inform clinical approaches around the world.

    We therefore continue this campaign.
    Thank you to all who have signed the petition. Please do keep spreading the word.

    Cochrane have now acknowledged receipt of our October complaint about the 2019 review; we expect a response soon.
     
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  2. Science For ME

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    On 13th November, the forum received the following letter from Cochrane regarding our letter of complaint:

    ___________
    Dear [member of the forum committee]

    I understand that my colleagues have already reviewed this complaint and responded.
    In line with previous correspondence sent to you, Cochrane will not withdraw the
    2019 review and we acknowledge that progress with the new review has been slower
    than we would have liked. The Independent Advisory Group is now meeting regularly
    and we expect to have an update soon.

    With best wishes
    Lucy

    Lucy Johnson-Brown
    Head of Governance
    Cochrane Central Executive Team

    _____________
     
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  3. Science For ME

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    As Ms Johnson-Brown had clearly confused the formal complaint with the open letter, the forum committee sent the following email in reply, on 17 November 2023, asking Cochrane to follow the complaint procedures it has set out on its website:

    ______________

    Lucy Johnson-Brown
    Head of Governance
    Cochrane Central Executive Team

    Dear Lucy Johnson-Brown,

    There appears to have been some misunderstanding in Cochrane. Our earlier letters to the Editor-in-Chief and others were in the form of requests with detailed reasoning provided. The only responses we had to those letters were a couple of brief replies from 'the office of the Editor-in-Chief' which simply turned down our request for withdrawal of the 2019 Exercise therapy for CFS review without explanation. However, the letter you most recently responded to was sent on 30th October under the Cochrane Complaints procedure and should therefore be dealt with other than by the 'office of the Editor-in-Chief', especially as the complaints are largely about the policies and actions of the Editor-in-Chief.

    In our complaint letter we set out five specific complaints about "failures and important misjudgements" in the "policies, processes and actions of staff", as per the stated complaints procedure. None of these, to our knowledge, has been addressed already, nor, as we stated in our letter, does the resumption of work by the IAG resolve any of the five complaints.

    We expect, as per the Complaints procedure, proper consideration of each of our complaints by some person or persons senior to the Editor-in-Chief who would normally consider complaints about her policies, decisions and actions. And, as per the stated procedure, we expect regular updates about progress on each of our five complaints. We would also expect to receive written decisions specific to each complaint, with reasons given if each complaint is not upheld, and action that will be taken in cases where complaints are upheld.

    We now understand from Hilda Bastian's November Independent Advisory Group update that detailed consideration was given to a complaint from people who wanted Cochrane to retain the 2019 Larun et al review and cancel the preparation of a new review. We understand that this involved meetings of several committees and more than a year to consider. We simply ask that our complaints about Cochrane's decisions affecting millions of people's health be taken seriously too.

    We are not making our complaints lightly. Our request to Cochrane to withdraw the 2019 review is backed by scientific evidence and supported by over sixty ME/CFS organisations around the world and nearly ten thousand signatories who are witnesses to the harm exercise therapy causes, and in many cases victims of this harmful therapy.

    The Editor-in-Chief herself admitted the 2019 review was not fit for purpose when she published it. Her refusal now to even consider withdrawing it despite significant developments since publication, and despite overwhelming evidence that it is not scientifically valid and is causing immeasurable harm is, we believe, unethical and a stain on Cochrane's reputation. We are confident that we have good grounds for all five of our complaints.

    We trust that the initial response was simply a result of misunderstanding and that now the appropriate person in Cochrane will promptly give due consideration to the complaints.

    Yours faithfully,
    Trish Davis, on behalf of the the Science for ME forum committee
    ______________
     
  4. Science For ME

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    On 17 November 2023, we received the following email from Ms Johnson-Brown, refusing to consider our letter of complaint:

    _____________
    Dear Trish

    We are committed to responding to complaints appropriately. Cochrane isn’t a government department or a public body, we are a relatively small charitable organisation. It is not possible for us to do what you are asking us to. We simply don’t have the resources to provide regular updates about progress on each of your five complaints, to provide written decisions specific to each complaint, with reasons given if each complaint is not upheld, and action that will be taken in cases where complaints are upheld.

    A decision has been taken to not withdraw the 2019 review and we have acknowledged that progress with the new review has been slower than we would have liked. I know that you and others strongly disagree with that decision.

    Our policies and processes have been developed to guide decision making, it is not always possible to meet self-imposed deadlines, but we are committed to continuous improvement and to reviewing our policies and processes regularly.

    I don’t think that there is anything more that I can say on the matter.

    With best wishes
    Lucy
    _____________


    A reply will be sent shortly.
     
  5. Science For ME

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    PETITION UPDATE
    Cochrane refuses to follow its own complaints procedure

    NOV 19, 2023 —

    As we have reported, the Science for ME committee submitted a series of complaints under Cochrane's official complaints procedure on 31st October about the Editor-in-Chief Karla Soares-Weiser's mishandling of our requests and failure to take action on the outdated harmful review. We asked Cochrane to follow its standard complaint management procedure as set out on its website. You can read a summary of the complaints here and the complaint letter in full here.

    In an initial reply from Lucy Johnson-Brown, Head of Governance, Cochrane Central Executive Team, copied here, there appeared to be some misunderstanding. She claimed wrongly that our complaints had already been addressed. After a further letter from S4ME, copied here, Ms Johnson-Brown replied:

    "We are committed to responding to complaints appropriately. Cochrane isn’t a government department or a public body, we are a relatively small charitable organisation. It is not possible for us to do what you are asking us to. We simply don’t have the resources to provide regular updates about progress on each of your five complaints, to provide written decisions specific to each complaint, with reasons given if each complaint is not upheld, and action that will be taken in cases where complaints are upheld.

    A decision has been taken to not withdraw the 2019 review and we have acknowledged that progress with the new review has been slower than we would have liked. I know that you and others strongly disagree with that decision.

    Our policies and processes have been developed to guide decision making, it is not always possible to meet self-imposed deadlines, but we are committed to continuous improvement and to reviewing our policies and processes regularly.

    I don’t think that there is anything more that I can say on the matter."

    The response appears to be saying that our complaints won’t be addressed. We will of course be pleased to hear that’s not what is meant.

    ____________

    Hilda Bastian's November 2023 update revealed that there had been a "lengthy and confidential process following a detailed complaint that called for the [new review production] process to be discontinued, and for the review to remain in its current form. The basis for incorporating an IAG into the editorial processes of a Cochrane review was challenged, as well as the need for an update, and the proposed editorial process..."

    Hilda revealed that the IAG process was put on hold while "Multiple committees within Cochrane’s organisation considered this complaint consecutively, which took around a year. The complaint was not upheld after thorough consideration by the Conflict of Interest Panel, a subgroup of the Editorial Board, and finally Cochrane’s Governing Board."

    So, Cochrane was willing to spend a year investigating a complaint in favour of the 2019 review, delaying the new review process to do so. Yet it now seems that Cochrane believe that it is okay to dismiss the well-founded complaints from S4ME without any semblance of consideration. Hilda has now announced that there will be another member added to the IAG of the new review process to counter perceived biases within the IAG.

    _____________


    What next?

    The campaign to remove the flawed and harmful 2019 Larun et al review continues. The S4ME committee is considering our next steps.

    Thank you

    Thank you to all the signatories of this petition and organisation supporting the campaign.

    Thank you very much to Schweizerische Gesellschaft für ME & CFS in Switzerland for adding its name to the list of organisations supporting this campaign. That addition brings the number of organisations calling for the 2019 review to be removed to 65, from 22 countries. You can find the full list here. If an organisation you are connected with isn't there, please tell them about this campaign.

    The Science for ME committee
     
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  6. Science For ME

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    On 20 November the Science for ME committee sent the following reply to Ms Lucy Johnson-Brown, Head of Governance, Cochrane Central Executive Team:

    _________________

    Dear Ms Johnson-Brown

    We are puzzled by your letter beginning: "We are committed to responding to complaints appropriately." This suggests that you intend to follow your complaints procedure. However, the rest of your letter makes it plain that you do not intend to do so in the case of our complaints.

    We are shocked that as the head of governance you are saying that you are not willing to follow the processes that Cochrane management and trustees have put in place. In your role we are sure you know the importance of following such processes to ensure the smooth running of an organization and to mitigate risks. To keep a review up and published that you know to be seriously flawed; not act in a timely manner in its replacement as Cochrane promised patients, and ignore patient reports of harm could lead to serious reputational risk. We would have thought that this risk increases significantly when an organization is seen to not only ignore complaints but to do so in violation of its organizational policies.

    In itself this is ethically questionable - perhaps you and your colleagues should be applying the headline or front page test. Could you defend Cochrane against a headline in a paper that says Cochrane failed to withdraw advice it knows to be flawed and dangerous, advice that over 60 ME/CFS organisations from around the world have told you is causing harm? A failure to follow your own complaints procedure only increases the ethical questions and subsequent brand risk.

    We have read Hilda Bastian's November update in which she outlines some reasons for the lengthy delay in work on the new review, including Cochrane dealing with some complaints. Cochrane's demonstrated willingness to entertain a complaint arguing against the 2019 Larun et al review being replaced, presumably from a relatively small group of people with vested interests in the recommended treatment, by investigating for over a year and involving multiple committees while ignoring a complaint from patient representatives increases the reputational risk even more.

    Can you confirm that the trustees have signed off on this exception to following your complaints procedure and that Cochrane intends to take no further action with respect to our complaints? Given the complaint includes actions of senior management it would be very strange for the trustees not to be informed of your organization ignoring its own policies and procedures or to be informed of the brand risks that the associated actions pose.

    Please confirm who has signed off on ignoring the complaints and the complaints procedure in this case and whether trustees have been fully informed of the issues.

    Yours sincerely,
    Trish Davis, on behalf of the Science for ME committee
    _________________
     
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  7. Science For ME

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    PETITION UPDATE
    December update
    DEC 18, 2023

    The day after our last petition update, the S4ME committee sent a letter to the Head of Governance, Cochrane Central Executive Team. You can find the letter here.

    In it, we queried Cochrane's earlier letter where they said first, that they were committed to responding to complaints appropriately, and then, made it clear that they would not be following their published complaints procedure for our complaints.

    We noted the substantial reputational risk that Cochrane runs in continuing to provide a platform for a review that it has acknowledged is flawed, in not acting in a timely manner in the production of a promised replacement review and in continuing to ignore the opinions of so many consumer organisations that the advice the review provides causes harm.

    We noted the double standards, where Cochrane spent over a year investigating a complaint from, presumably, a relatively small group of people who don't want the 2019 Larun review to be replaced. This extensive investigation is reported by Hilda Bastian to have significantly delayed the replacement review and, it appears, has resulted in concessions including more representation of the pro-GET lobby on the "Independent Advisory Group" of the new review.

    We asked Cochrane to confirm that the trustees had signed off on the departure from their published complaints procedure for our complaints. We noted that this would surely be required, given that the complaints were against the actions of senior management, and also given the reputational risks. It would be very odd if it was thought acceptable for a complaint against a Cochrane officer to be evaluated only by that officer.

    We have not yet received a reply.

    ______________

    The S4ME committee is considering what action to take next.

    We intend sometime soon to formally present the petition to the Cochrane trustees, highlighting in doing so the many comments by petitioners, and the names of the organisations supporting this campaign. If we take our complaint to COPE or the UK charity commission, that may need to be done with some level of confidentiality in order to comply with their rules.

    Thank you again to all the individuals who have signed the petition, added your own testimony to the harm exercise therapy has caused to you or your loved ones, and spread the word about the petition to others with ME/CFS and Long COVID and their supporters. Please keep doing so.

    Thank you also to the many organisations who have signed in support. Do please get in touch with the S4ME team on moderators@s4me.info if your organisation wants to sign or has other ideas of ways to help.

    Thank you to the following organisations for adding their names in support of the open letter here bringing the total number of organisations to 69, and, with organisations from Poland and Austria, the number of countries represented to 24.

    Grupa Wsparcia ME/CFS, Poland
    Norwegian ME Association, Østfold region
    ME/CFS Research Foundation gGmbH, Germany
    WE&ME Foundation, Austria

    While Cochrane still hosts a review that recommends exercise as therapy for ME/CFS, the harm continues, so the fight for health and justice must continue too.

    _____________

    We hope that, as this year draws to an end, you have loved ones close and that the new year brings us all peace, joy, good science and compassion.

    Best wishes, the Science for ME team

    _____________
     
  8. Science For ME

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    The committee received the following email from Cochrane on Tuesday 19th December. We have also posted it on the Petition thread so members can comment.
    ___________

    Dear Trish Davis and the Committee of Science for ME international forum,

    Thank you for your correspondence, which has been referred to me.

    We are committed to taking complaints seriously, and to following Cochrane's established processes and procedures. [1] For example, as we note on our website, [2] previous complaints on some of the issues you have raised were also made in 2020. Those were investigated by a sub-group of Cochrane’s Editorial Board and a Cochrane Coordinating Editor, who agreed that the published review did not warrant withdrawal based on those complaints.

    Our procedures can involve referring complaints within the organization, for example, to our conflicts of interest panel. This depends on the matters raised within the complaints, not on who made the complaint.

    We regret the lengthy delays to this project. As indicated in Hilda Bastian’s November report, [3] the next steps for this review are currently in planning. When there is a timetable and further details, this will be included in public updates. As also reported, since the review process will take some time, Cochrane will be working with the Independent Advisory Group on a revised editorial note with the aim of reducing the chances of misinterpreting the current review.

    The Cochrane Governing Board is informed about developments relating to this review. I recognize that this email does not address the concerns and complaints you have sent in previous correspondence. However, the other matters you have raised are under review, and we will get back to you in due course.

    Kind regards,

    Jordi Pardo Pardo

    Interim Chair. Cochrane Governing Board.
     
  9. Science For ME

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    PETITION UPDATE

    15 February update

    We are still waiting

    Six years ago this week, the late Robert Courtney (Bob) sent a letter of complaint about the 2017 version of the Larun et al Exercise Therapy for CFS Review to the then Cochrane Editor, David Tovey. Tovey acknowledged the validity of the complaint and did not publish the next iteration of the review. The current editor, Karla Soares-Weiser, also acknowledged the revised review was flawed, but published it anyway in October 2019, setting out a plan for its replacement within two years. We are still waiting for that flawed 2019 review to be removed.

    So, six years on, wonderful people with ME/CFS like Bob are still dying much too early, harmed in many ways by people who think the disease can be cured by exercise.



    An update from the Cochrane IAG
    There was an update from Cochrane's Independent Advisory Group for the planned new review on 20 December 2023 - available here

    Under the heading of Preliminary Timetable for the New Year, it is noted that a new timetable for progress on the new exercise therapy review (which is already years overdue) might be provided in the next report. There is also a promise of future consultation on a forthcoming paper summarising past critiques of the old review.

    Notably, nothing at all was said in this update about the consultation on the draft protocol for the new review that was promised in the previous update. A protocol plays a large part in defining the outcome of a review. It is crucial to progress, and yet a consultation process on it seems to be so far away now that it can no longer even be promised.

    Also notably, no timeline was given for the previously promised revision of the editorial note on the 2019 review, nor any indication of what it might say. Like so many things with Cochrane, it is promised to happen at some unspecified point in the future.

    Under the heading of Complaints and Communication, we are told that Cochrane, an organisation which has been operating for years with a self-appointed mandate to provide authoritative medical advice to the world, has now agreed on 'pathways for referring complaints' which it is hoped will improve responsiveness in the future. It seems that it has been operating without an adequate quality control system.

    There has been some activity around adding yet more members to the Independent Advisory Group though. One remaining position is to be filled by someone who addresses "concerns expressed about a perception of bias in the makeup of the IAG". Given that we are not aware of concern being expressed by patient representatives, we assume the concern was expressed by a proponent of exercise therapy for ME/CFS. Given it is noted that the desire is to have a medical professional who works with patients with ME/CFS, it seems likely the appointee will make their living from recommending exercise therapy to people with ME/CFS. We would love to be proved wrong.

    This adding of IAG members seems to be more re-arranging of the deckchairs on a ship being steered towards its preplanned destination. It is not at all clear what authority the IAG has in the production of the new review. The issue of the IAG composition is a distraction from the fact that the 2019 review continues to stand, continues to be endorsed by Cochrane and continues to cause harm. It is not clear in what year a replacement review will eventually be produced, if ever.



    Letter from Cochrane
    On 19th December the S4ME committee received a response to our letter of a month earlier in which we, among other things, queried their complaint management approach. In this letter, Jordi Pardo Pardo, Interim Chair Cochrane Governing Board, said that some of the points we have raised had been considered already after complaints in 2020. He concluded his letter with "However, the other matters you have raised are under review, and we will get back to you in due course."

    Two months on, we have yet to receive any further correspondence from Cochrane and it is not clear which complaints are being considered and which ones have been dismissed. For more information about this, see the Science for ME thread.



    More than 10,000 signatures!
    Many thanks to everyone who has shared the petition link, helping the total number of signatures from all over the world to now be well over 10,000. Please continue to share the link, and continue to inform people in the ME/CFS and Long Covid communities about this issue.

    For a list of the 69 organisations who are supporting the campaign for the removal of the flawed review, see here. If an organisation that you are associated with isn't listed, please encourage them to learn about the issue and add their support.
    _______________
     
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  10. Science For ME

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    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.

    For discussion of the letter, go to the Petition thread.
     
    Last edited by a moderator: Mar 18, 2024
  11. Science For ME

    Science For ME Forum Announcements

    Messages:
    1,162
    PETITION UPDATE
    21 March 2024

    21 Mar 2024
    Petition presented to Cochrane with a renewed call for withdrawal on the basis of harms

    On 17th March 2024, the Science for ME committee wrote 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



    We marked 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 presented the petition to Cochrane and encourage them to read the comments on it. We also listed the 70 organisations that have signed in support.

    We asked that the 2019 Larun review be urgently withdrawn, on the grounds of harm.



    We gave 10 reasons for the review to be withdrawn, under these headings:

    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 concluded:

    "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."



    *******************

    With thanks to all our supporters, the campaign continues.
     
  12. Science For ME

    Science For ME Forum Announcements

    Messages:
    1,162
    The following response has been received from Cochrane:

    Dear Trish Davis and the Committee of Science for ME international forum,

    Thank you for your correspondence. We will include the additional points and references to studies in our review of the issues raised by S4ME in previous correspondence. This thorough process will take some time, and we will get back to you about this in due course.

    In the short term, some of the questions will be addressed on the Cochrane project website. We will keep you informed of progress.

    Kind regards,

    Cochrane Support
     
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  13. Science For ME

    Science For ME Forum Announcements

    Messages:
    1,162
    PETITION UPDATE

    30 May 2024
    Thanks to our supporters
    Thank you to the more than 11,000 people who have supported the campaign. With the most recent additions from Zambia and Nepal, people from 76 countries have signed.

    Thank you also to the following organisations for adding their support to this campaign:
    Solve M.E. - USA
    UK All Party Parliamentary Group on ME - UK Members of Parliament with an interest in ME/CFS
    Chester MESH self help group - England
    Long Covid Switzerland
    Long Covid Kids Switzerland
    Minnesota ME/CFS Alliance - USA

    These additions bring the number of organisations calling for the 2019 review to be removed to 75, including most national ME/CFS charities. You can find the full list of supporting organisations on the forum. If an organisation you are connected with isn't there, please tell them about this campaign.

    People with ME/CFS following Covid-19 infections are also being targeted with psychobehavioural therapies such as graded exercise. It is important that Long Covid organisations understand that there is no credible evidence to support the use of graded exercise therapy in post-infection fatigue syndromes. If you know of a Long Covid organisation, please consider informing them about this campaign.

    *******
    A reply from Cochrane
    In our last petition update in March 2024, we told you that we had officially presented the petition to Cochrane, along with 10 reasons for why the flawed 2019 exercise therapy review should be withdrawn.

    We have received a brief reply from Cochrane in early April, as follows:
    Thank you for your correspondence. We will include the additional points and references to studies in our review of the issues raised by S4ME in previous correspondence. This thorough process will take some time, and we will get back to you about this in due course.

    In the short term, some of the questions will be addressed on the Cochrane project website. We will keep you informed of progress.

    Kind regards, Cochrane Support


    *******
    The broken promises continue
    There are so many, that we have decided to just cover two in each of our updates. Here are the first two:

    Broken promise 1. Monthly updates from the Independent Advisory Group (IAG)

    In October 2019, Cochrane’s Editor-in-Chief, Dr Karla Soares-Weiser, said about a planned replacement review

    "I can confirm that work will begin on this new review at the beginning of 2020 and that we will keep patient groups regularly informed of progress during the subsequent months.”

    In May 2021 Hilda Bastian apologised for the slow progress on the new review and promised that there would be monthly reporting from the IAG going forward. Since then, until now, there have been only four further brief updates.

    In November 2023, after no news for nearly 2 and a half years, Hilda promised that the monthly updates would resume. There was an update in December 2023, but there have been none at all in 2024.


    Broken promise 2. Revision of the editorial note on the 2019 Review
    In both the IAG November and December 2023 updates Hilda Bastian indicated that there would be a revised editorial note placed on the 2019 Review. Hilda said:
    "As discussed in my last report, the editorial note on the current review on exercise and ME/CFS will be revised."
    Since that time, there has been no news about when a revised editorial note can be expected, nor what the note might say. Of course, the 2019 review should be removed. But while that review remains, a prominently displayed editorial note saying that it should not be used to guide clinical practice could reduce the harm.

    *******
    While Cochrane continues to obfuscate and delay, people continue to be harmed by their faulty advice. Thanks again for your support as we continue to try to stop the harm.

    If you would like to help the campaign, you are very welcome to join us at the Science for ME forum.

    The Science for ME committee
     
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