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

Following member discussions, a forum poll and discussions by forum staff and the committee, the following letter has now been sent by email to the Editor-in-chief, Karla Soares-Weiser, and copies to the Governing board, Cochrane Council, Consumer Engagement and Hilda Bastian, head of the IAG.

Links to this thread can now be shared on social media.

Due to the substantial response from supporters, people and organisations wanting to support this letter can now add their names to a change.org petition: link
The forum thread on the petition is
Petition: S4ME 2023 - Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review

_______________________________________


To Karla Soares-Weiser, editor in chief, Cochrane
Copies to: Cochrane's governing board, central executive team, council, editorial board, authors of the planned review, Hilda Bastian, IAG leader and IAG members.

Subject: Cochrane reviews of Exercise therapy for Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)


Dear Dr Soares-Weiser,

We are writing to you to request that you take urgent action on the following. The reasons are set out below.

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.

AND

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.
___________________

1. The 2019 review by Larun et al.

As shown on the attached document, Dr Soares-Weiser acknowledged on 2nd October 2019 that the review 'Exercise therapy for chronic fatigue syndrome’ was already outdated at the time of its publication. Dr. Soares-Weiser announced at the same time plans for a new review which was expected to be completed in two years.

The Larun et al. review is severely flawed, as demonstrated by Michiel Tack's detailed commentary, Problems with the amended version..., published by Cochrane on 20th August 2020. Consideration of Tack's complaint was deferred on the grounds that his points would be considered as part of the new review. In his reply on 20th August 2020, John Hilton, Cochrane Senior Editor, says:
"This review and its protocol are in the process of being updated as a priority."

The findings of the Larun et al. review are incorrect, as demonstrated by the NICE and CDC evidence reviews which concluded that graded exercise therapy should not be used as treatment for ME/CFS and there is no evidence to support the use of exercise therapies in general to treat ME/CFS. Yet Larun et al continues to be cited in evidence in support of exercise therapy for ME/CFS in other guidelines and articles in medical journals and the media, leading to ineffective treatment and to serious ongoing potential for harm.

Given the above, it is clear that the 2019 review by Larun et al should never have been published and older versions should have been withdrawn or retracted. It should now be withdrawn immediately.
_________________

2. Progress on the new review:

The new review process was launched as an example of a new approach, with stakeholder involvement and engagement at its core. In May 2021 there was a promise of monthly updates. As shown in the attached document and summarised below, the process appears to have failed. There has not been even an update for two years.

Summary timeline:

2nd October 2019
Announcement of the new review process by Karla Soares Weiser
"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.”

February 13, 2020
Appointment of lead to independent advisory group Hilda Bastian

May 2021
Update by Hilda Bastian
"[due to the pandemic]... it might not be possible to reach the original goal of a finalised review in early 2022. However, that is still the aim."
"there will be a new protocol. After peer review, it will be released for a very short consultation period – we hope to reach that point in the third quarter of the year [2021]."
"We will report on the project's status and progress at least monthly from now on."

June 2021
Update by Hilda Bastian
"We hope to get to that draft protocol before the end of the third quarter of the year."
The IAG was also working on a discussion document:
"The IAG will be starting an engagement process around this analysis in the coming weeks."

August 2021
Update by Hilda Bastian
"Engagement beyond the membership of the IAG will be a major focus of this project...
This will begin with the release of the list of discussion points and the accompanying discussion paper.

There have been no further updates and there has been no public consultation.

2022-3
As listed on the attached document, over the last two years there have been attempts to contact the IAG via Cochrane and via social media, with either no response, or only vague responses that the process is under way. For two years, there have been no monthly updates, none of the promised public consultation, and no information on when any progress might be expected.

This clearly unacceptable situation must not be allowed to continue.
__________

3. Impact

For readers of this letter unfamiliar with ME/CFS and its core symptom post-exertional malaise, we recommend taking a few minutes to read Pullizer Prize winning journalist Ed Yong's article Fatigue Can Shatter a Person published in July 2023 in The Atlantic. For non subscribers an archived version can be read here.

There is added urgency for action by Cochrane as many more people following Sars-COV-2 infection, likely numbering around the world in millions, are being diagnosed with ME/CFS and/or fulfill the modern diagnostic criteria for ME/CFS including post-exertional malaise (PEM). It is becoming clear from research and social media that many of those with PEM subjected to exercise therapy are being harmed, possibly permanently. Yet the 2019 Larun et al review is being used to support ongoing recommendation of exercise therapy for people with ME/CFS and Long COVID. This must not be allowed to continue.

There is also concern among scientists, clinicians and people with ME/CFS that the continued hosting of the Larun et al review by Cochrane is being used to justify articles in scientific journals and in the media and guidelines that support this outdated treatment.

It is not sufficient to have a note attached to the review saying a new review is under way, when that new review has not materialised in a timely fashion.
_____________

This letter and any replies we receive will be published on the public Science for ME forum and copied on other media and social media as we consider appropriate.

We look forward to your considered reply and swift action.

Cochrane's reputation and, more importantly, the health of millions of people, are at stake.

Yours faithfully,
the Science for ME committee, on behalf of members of the Science for ME forum,
an independent, patient-led, international forum for people with ME/CFS and the carers, clinicians, scientists and advocates who support us

The letter has been posted publicly, together with a list of individual signatories here:
S4ME: 2023 Open Letter to Cochrane - request for action on the ME/CFS Exercise Therapy Review

 

Attachment to the letter
___________________________________

Part 1: The old Cochrane Exercise Review

First published 10 February 2015, revised 5 times.

Exercise therapy for chronic fatigue syndrome
Information gives the history of all reviews on this topic including the following:

October 2018
"This review is subject to an ongoing process of review and revision following the submission of a formal complaint [by the late Robert Courtney] to the Editor‐in‐Chief."

August 2019
"This published note, generated in August 2019, relates to the review version published on 2 October 2019 (doi.org/10.1002/14651858.CD003200.pub8).

In 2018, following receipt of a formal complaint about the Cochrane Review, 'Exercise therapy for chronic fatigue syndrome', the then Editor‐in‐Chief of the Cochrane Library, Dr David Tovey, commissioned an appraisal of the published review by his team. The findings of this assessment were shared with the authors in September 2018. It was judged that the authors could have an opportunity to address the complaint by amending the published review, instead of withdrawing it.

The authors submitted an amended version of the review, which was assessed further by independent editors in November 2018. Following their assessment, in December 2018 the authors were asked to make additional changes. In early 2019, the Editor‐in‐Chief and the authors jointly agreed to an extension until the end of May 2019 to address all the comments. This amended review has now been accepted for publication by Dr Karla Soares‐Weiser, who took over as Editor‐in‐Chief in June 2019."

2 October 2019 Current Version published:
Exercise therapy for chronic fatigue syndrome
Lillebeth Larun, Kjetil G Brurberg, Jan Odgaard-Jensen, Jonathan R Price

2 October 2019
Statement published by Cochrane on the same day as publication of the review:
Publication of Cochrane Review: ‘Exercise therapy for chronic fatigue syndrome’
"Today, Cochrane publishes an amended version of the Review. In the last nine months, this Cochrane Review has been modified by the review’s authors and evaluated by independent peer reviewers and editors. It now places more emphasis on the limited applicability of the evidence to definitions of [ME/CFS] used in the included studies, the long-term effects of exercise on symptoms of fatigue, and acknowledges the limitations of the evidence about harms that may occur.

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,..."
(See part 2 for the rest of this statement)

February 2020
Note added from the editorial team at Cochrane Editorial and Methods Department on 6 February 2020: "A statement from the Editor in Chief about this review and its planned update is available here."

26 August 2020
Problems with the amended version by Michiel Tack.
Headings:
1) ‘Long-term’ follow-up results downplayed
2) Fatigue post-treatment should be rated as low instead of moderate quality evidence
3) Problems with the Chalder Fatigue Scale
4) Bias due to lack of blinding
5) Objective outcomes not reported
6) No information on compliance
7) Indirectness of evidence: outdated diagnostic criteria
8) Reports of harm not mentioned
9) Selective reporting in the PACE trial

26 August 2020
Response from Cochrane
Note on the status of this review
John Hilton, Cochrane Senior Editor
"Response from the editorial team at the Cochrane Editorial and Methods Department:

We thank Michiel Tack for the feedback on this review, and we appreciate the thorough and well-referenced comment. This review and its protocol are in the process of being updated as a priority. The update is being informed by an independent advisory group of people living with ME/CFS, clinicians, and researchers. We will ensure that the comments you have provided will be reviewed during the updating process by the independent advisory group and the authors of the review.

Further information about the review update, and reports on progress, will be posted to the following website: https://community.cochrane.org/orga...eholder-engagement-high-profile-reviews-pilot"
______________

The 2019 Larun et al. review has not been withdrawn as requested by many patient groups and is still being used as evidence for recommendation of graded exercise therapy (GET), despite the evidence reviews for the UK 2021 NICE guidelines and US CDC finding the research evidence does not support the use of GET as a treatment for ME/CFS, and the many reports of harm.

Examples:
2022
The Lancet: New NICE guideline on chronic fatigue syndrome: more ideology than science? - Flottorp et al.
Letter in response by Professor Jonathan Edwards

2023
Anomalies in the review process and interpretation of the evidence in the NICE guideline for (CFS & ME) - White et al
Rapid responses
Shortcomings in the commentary by White et al - Salisbury et al
______________________________________

Part 2 The new review

2nd October 2019
Announcement of the new review process by Karla Soares Weiser
"... 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.”

She added, “By forging better relationships with patients, as well as the groups that represent them and the clinicians who seek to treat them, we can improve the way in which future Cochrane Reviews in this area address important questions and meet patients’ and clinicians’ needs. 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.”

February 13, 2020
Appointment of lead to independent advisory group
"Cochrane is now pleased to announce that Hilda Bastian has been appointed to lead the independent advisory group.
...
There will be further announcements as the independent advisory group, protocol and review update progress.

The independent advisory group can be contacted directly on cochrane.iag@gmail.com."

30th May 2020
Absolutely Maybe blog by Hilda Bastian: Let’s Be Serious About Bias in Protocols of Systematic Reviews

"But when it’s not tokenistic whitewashing, consultation can be powerful. The establishment of the Independent Advisory Group in this case is a commitment to genuine accountability and responsiveness: it provides a mechanism for establishing open discussion of the protocol, beyond the confines of peer review that’s outside public scrutiny."

Cochrane Exercise and ME/CFS Review Update: May 2021
"Summary
Like many projects planned before the pandemic, this one was deeply affected by the upheavals of 2020. As a result, it might not be possible to reach the original goal of a finalised review in early 2022. However, that is still the aim.

Progress in four areas is reported in some detail in the body of this report:

• gathering and analysing community concerns about the review as a starting point for the update, and as a framework for engaging with stakeholders;
• establishing new editorial arrangements for the review;
• recruitment of the review team, including consumer authors; and
• formation of the Independent Advisory Group (IAG).

One of the working products of the process will be a paper from the IAG that will provide a framework for consultation in the coming months.

For this updated review, there will be a new protocol. After peer review, it will be released for a very short consultation period – we hope to reach that point in the third quarter of the year. There will be opportunity for stakeholders to raise their concerns in virtual meetings, as well as in writing, before the protocol is finalised and published.
...
Although work has been progressing, this report and wider stakeholder engagement in the process is very long overdue, and I apologise for that. We will report on the project's status and progress at least monthly from now on.

The IAG will be responsible for responding to stakeholders and other interested parties, so enquiries and feedback relevant to this review will be referred to us. You can contact us directly at cochrane.IAG@gmail.com"

(Full report at link, including writing group and IAG members announced.)

Cochrane Exercise and ME/CFS Review Update: June 2021
"This month, there are updates on:

• The role of the IAG in the editorial process for the review;
• Preparing for our first consultation; and
• Membership of the IAG.

We hope to get to that draft protocol before the end of the third quarter of the year. However, with so many groups of people and feedback loops involved, it’s hard to be sure how quickly this will go.

• The authors are working on the protocol – and the IAG will be providing advice along the way, including about the first draft before peer review.

• When the final protocol is published, comments can be submitted to The Cochrane Library – and plans will be developed for further progress.

If there are differences between the review team and the IAG that can’t be resolved between them, the final decision on that issue will be made by the Editor-in-Chief.

Preparations for our first consultation: the critique story so far

Last report, I explained that our starting point had been the critiques of the review made from 2008 to 2020, and a content analysis of the issues raised in them...

The discussion points have been summarised into very brief descriptions, and there are over 100 of these now. The IAG will be starting an engagement process around this analysis in the coming weeks.

We will be seeking input on whether those summaries cover all the aspects of the Cochrane review that stakeholders want to raise. And it will introduce the community to the way we’ll be using this framework through the editorial process, so people can see how new issues can get on the agenda as the review develops.

This first IAG document will be the start of a series of efforts that we hope will facilitate engagement with the draft protocol when it comes in the next few months...."

Cochrane Exercise and ME/CFS Review Update: July 2021
Posted online: 4 August 2021

"This month, there are updates on:

• Progress on developing the first document for consultation, including comparing the methods of major recent reviews by other groups;
• Membership of the IAG; and
• Developing processes and policies for consultation and engagement.

Alongside this process, we have been working on a technical document comparing the specific methods used in the current version of the Cochrane review and the draft systematic reviews released by National Institute for Health and Care Excellence (NICE) in the UK and the Centers for Disease Control and Prevention (CDC) in the US.
We will be considering whether including the relevant segments of this comparison provide useful context within the discussion paper, too. As we get closer to the consultation on the draft protocol for the update of the Cochrane review, seeing the similarities and areas of difference between the methods chosen by different groups of systematic reviewers may be useful to many people.

Processes and policies for consultation and engagement
Engagement beyond the membership of the IAG will be a major focus of this project. This will include a range of opportunities for participation. A key focus will be consultations, the first of which will focus on the discussion paper built on criticisms of the Cochrane review since 2008.

This will begin with the release of the list of discussion points and the accompanying discussion paper. The IAG will be testing out a process for online submission of comments shortly, as well as discussing additional options for engagement around this process.

We will also be developing a policy for the IAG on engagement broadly, covering aspects typically addressed by policies people develop, for example, to moderate discussion forums, or to run consultations for public agencies."
______________________

There has been no information posted on the Cochrane website since the above report from Hilda Bastian on 4th August 2021. All attempts to elicit responses via the IAG email address have been unsuccessful.

During 2022 several attempts were made via social media. Those we are aware of are as follows:
March 2022
Cochrane was asked and said an update is expected but they can't give a date.

March 2022
From Cochrane in response to a query:
"...apologies for the lack of information on the exercise therapy for ME/CFS. We are planning to send an update about the status of the review and plans for the next steps, but the timing of the communication has yet to be confirmed. We will ensure it is shared with the ExerciseForMe-CFSUpdates subscribers."

March 13 2022
Hilda Bastian on Twitter;
"It has been moving forward: lack of progress reports does not necessarily mean lack of review progress - these involve different groups of people."

March 2022 Caroline Struthers wrote to Cochrane to ask for updates and whether Cochrane reviewers would use the NICE anaysis of research.
April 2022 Cochrane replied saying "this issue is under consideration".

June 2022 Hilda Bastian wrote
"We're in the process of preparing an update on progress, including plans for wider consultation."

31 August 2022 Hilda Bastian replied on Twitter to a question of when the next report might be coming:
"Not this week or next week, but can't be sure when."

2023

17 March 2023 in response to an email sent to the press office:
"Thank you for getting in touch. The update is currently underway and we are hoping to publish the protocol for consultation in the coming months. Unfortunately I am not in a position to be more specific at this stage but would be happy to update you once the protocol is published.
Harry Dayantis
Head of Communications
Cochrane Central Executive Team"

August 2023
By private communication:
"the draft protocol was submitted in February [2023] and ... the IAG took on responsibility at that time".
___________________

 

Organisations supporting the letter and campaign

International
Science for ME
ME Global Chronicle
World ME Alliance
Physios for ME
European ME Coalition (EMEC)

Austria
WE&ME Foundation

Australia
Emerge Australia

Belgium
12ME (Belgium)
Millions Missing Belgique

Canada
Millions Missing Canada

Denmark
Foreningen for Myalgisk-Encefalomyelitis - Danish ME Association
Millionsmissingdenmark

Finland
Suomen ME/CFS-yhdistys ry - The Finnish ME/CFS Association

France
Millions Missing France

Germany
German Association for ME/CFS | Deutsche Gesellschaft für ME/CFS e.V.
Lost Voices Stiftung
ME/CFS Research Foundation gGmbH
Fatigatio e.V. Bundesverband ME/CFS

Ireland
ME Advocates Ireland (MEAI)
Irish ME/CFS Association

Israel
ME/CFS Israel

Italy
CFS/ME Associazione Italiana
CFS/ME Organizzazione di Volontariato

Japan
Japan ME Association

Netherlands
ME Centraal, the Dutch ME-info channel
Millions Missing Holland
Steungroep ME en Arbeidsongeschiktheid

New Zealand
Post Viral Research Aotearoa
ANZMES
M.E. Awareness NZ
Long Covid Support Aotearoa
MECFS Canterbury (New Zealand)
ME Support New Zealand

Norway
Norwegian ME-Association
ME Foreldrene (ME Parents)
Millions Missing Stavanger
Norwegian ME-association Trøndelag
Norwegian ME-association Rogaland
Norwegian ME-association Møre and Romsdal
Norwegian ME-association Innlandet
Norwegian ME-association Vestland
Norwegian ME-association Buskerud
Norwegian ME-association Troms
Norwegian ME-association Vest Agder
Norwegian ME-association Aust Agder
Norwegian ME-association Vestfold
Norwegian ME-association Oslo og Akershus
Norwegian ME-association Østfold

Poland
Grupa Wsparcia ME/CFS

South Africa
ME CFS Foundation South Africa

Spain
CONFESQ
ONG PEM Asociación de Personas con Encefalomielitis Miálgica

Sweden
RME Sverige
RME Kronoberg Blekinge
RME Östergotland
RME Skåne
RME Väst
#MillionsMissing Sweden
RME Stockholm
RME Jönköping

Switzerland
Schweizerische Gesellschaft für ME & CFS
Long Covid Switzerland
Long Covid Kids Switzerland


United Kingdom - England, Northern Ireland, Scotland, Wales
Hope 4 ME & Fibro Northern Ireland, Board of Trustees
Bury/Bolton ME/CFS & Fibromyalgia Support Group, UK
25% ME Group (United Kingdom)
Welsh Association of ME & CFS Support (WAMES)
ME Association (United Kingdom)
Action for M.E. (United Kingdom)
#MEAction UK
#MEAction Scotland
LocalME - 52 local support and advocacy groups primarily across the UK
All Party Parliamentary Group on ME
Chester MESH Self Help Group
The Grace Charity for M.E.
#ThereForME

United States of America
Long Covid Families
Minnesota ME/CFS Alliance
Solve M.E.









Individuals supporting this letter
Most of the people listed below indicated support for the letter prior to the set up of the petition.

For more names of people and organisations supporting the letter, see Change.org Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review, with nearly 9,000 signatures from people in 72 countries on 24 October 2023.


Trish Davis, Science for ME staff member, ME/CFS for 33 years, carer for 25 years, UK

Maree Candish, Science for ME committee member, New Zealand

Dr Adrian Baldwin, Science for ME committee member, UK

SBM Kirby, Australia

John Peters

Richard Vallée, ME/CFS for 15 years

Peter Trewhitt MA, MSc, Dip Cl Com St, MRCSLT (retired), UK

Gregory Sanders, England, UK

Vivien Pomfrey, MSc, UK

Gillian Bigglestone, MSc, UK

Dr Olivia Beatty MD MRCP, UK

Ann West, UK

Ash, UK

Susan Spaulding, retired RN, United States

David Davies-Payne, MB ChB, FRANZCR, Starship Children's Hospital, Auckland, New Zealand

Callum Nicholls, New Zealand

Laurie Pelis, USA

Ágnes Szarvas, Hungary

Sarah Restieaux

Astrid Meyer-Knutsen, Norway

Dominique Doran, New Zealand

Dr Caroline Mary Mann, MBChB, MRCS, FANZCA, MMEd, Specialist Anaesthetist,
Starship Children's Hospital, Auckland, NZ

Sally Burch. BSc (hons) Biology, Lay member on NICE guideline committee for ME/CFS. Northern Ireland.

Veronica Jones, England, Severe ME patient since 1997

Susanne Bressan, Person severely disabled by ME/CFS, Germany

Mrs. Joan McParland MBE, Founder, Hope 4 ME & Fibro Northern Ireland

Lene Christiansen, me/cfs for 24 years

Linda Campbell, MSc Nursing, Advanced Nurse Practitioner Primary Care, Chair and Healthcare Professional Educational Advisor for Charity Hope 4 ME & Fibro NI.

Ian Johnson, England, Moderate/severe ME patient since 1986

Rob Wijbenga, The Netherlands, co-founder/editor-in-chief of the ME Global Chronicle and co/founder, admin & moderator of the Dutch ME-info channel ME Centraal.

Lucy A Bailey MSc, UK

Maria Sale, ME/CFS for 32 years

Kitty Parker

Francis Martin

Lidia Thompson BSc, PGCE, ME/CFS for 35 years

Professor Dr Jonas Bergquist, Director ME/CFS Research Centre, Uppsala University, Sweden

Simone Eyssens, former psychologist, lives with severe ME/CFS, Australia

Shannon Clem, patient, USA

Louise Skelley

Eric Topol, MD, Professor and EVP, Scripps Research

Timothy Chambers, Australia

Svetoslav Batsoev, Bulgaria

Dr Belinda Rowland, (BMedSc, BMBS, DCH, FRACGP), Australia

Simon Del Favero, Australia

Danilo Buonsenso, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, Italy

Elisa Josefa Oltra Garcia

Anatol, ME/CFS patient

Barbara Lees

Stephen Walden, USA

Sissel Sunde, MillionsMissing Stavanger, Norway

Nina E. Steinkopf, www.melivet.com

Randi Line Finnes, Norway

Tine Kristensen

Gunhild Bay, Patient, Norway

Lena Kjempengren-Vold

Jorn T Haugen

Venke Midtlien

Hege Hansen, ME for 11 years

Kaja Heilo, Norway

Heidi Anita Hervik

Herberto Dhanis, biomedical engineer with a PhD in neuroscience

Anette Gilje

Susanna Agardy, Australia

Heidi Borresen, Norway

Marit Stafseth

Kari Cotton

Elen Lovis Nornes

Anita Saur Haukvik

Ingegjerd Arnes

Cathrine Kjeilen Nygaard

Kathrin Storheil, Norway

Aslaug Angelsen, RD, MSc, Norway

Henrik A. Sve, MA, Norway

Daniel Missailidis, PhD (ME/CFS biomedical research scientist for 8 years)

Marit Wohni

Heidi Hansen

Harald Krisner, Norway

Marjon Wormgoor, Norway

Grete Lilledalen

Anne-Cathrine Rodriguez, Norway

Peter la Cour, Health psychologist, professor, Denmark

Mari Anne van der Pool

Claudia Heath, Carer for my son with M.E., Australia

Dr Carolyn Wilshire, School of Psychology, Te Herenga Wake - Victoria University of Wellington, New Zealand

Kristin Lyslo Pedersen

Renate Øvreseth, Registered Nurse and Midwife, now ME patient, Norway

Froydis Lilledalen ME-patient, writer and psychologist

Karen Stevenson, Diagnosed CFS and Fibromyalgia, USA

Michelle Strausbaugh, Portland, OR USA, patient 22 years

Gilles, France

Tanja Mediaa

Jackie Goold, UK

Knut Hillers

Robert Saunders, UK ME/CFS patient for 31 years.

Dr Nicholas Mann, MD, FRCP, FRCPCH, DCH, retired consultant paediatrician, Royal Berkshire Hospital, UK

Elizabeth Edwards, Person with ME/CFS for 50 years +, Australia

 

Thanks
The forum committee acknowledges the considerable effort made by @Trish in drafting the letter and by forum staff in general in facilitating this advocacy effort. We would also like to thank the many members who have added their support to the letter and who have encouraged others to also add their names.


A new and better way to indicate your support for the letter - a Change.org petition
In response to the considerable expression of support, we have created a Change.org petition where people can add their names and the names of organisations directly. The link is here
Change.org Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review
Please consider adding your name to the petition, even if you have already added your name to this thread. Please share the link and encourage others to add their names if you can. (If we receive further emails from people wanting to add their names in support, we will add them to the post above.)

Number of people who have signed the petition as of 24 October 2023: 9000


Response from Cochrane
Science for ME has received several emails from Cochrane personnel acknowledging receipt of the letter. We have, however, not yet received any substantive reply. We will keep you informed.

 

As of today (18 September 2023), Science for ME has still not received any response from Cochrane other than acknowledgement of receipt.

On the 17 September, the forum committee sent the following followup email to a substantial number of Cochrane officers and Hilda Bastian. It notes the establishment of the petition.

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

Dear ...

We request your assistance in ensuring prompt action is taken by Cochrane on the serious issues related to its reviews of exercise therapy for the disease that has been known as chronic fatigue syndrome (CFS) and is now referred to as ME/CFS.

On 31st August 2023, the committee of the international Science for ME forum sent an open letter to the Cochrane Editor-in-Chief, Dr Karla Soares-Weiser. If you have not seen it, we ask you to read the letter and attached document, both posted on the forum.

On 4th September 2023, the forum committee set up a Change.org petition to enable the many people who wished to support the open letter to add their names.

The petition says:

"Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review

This petition has been posted on behalf of the committee of the international Science for ME forum:

People with ME/CFS are being harmed by inaccurate clinical advice resulting from a flawed Cochrane Review.

Cochrane is an international organisation that publishes reviews of research evidence for treatments of diseases; it has a lot of influence over clinical guidelines used around the world. Four years ago, in October 2019, Cochrane published 'Exercise therapy for CFS', supporting the use of exercise therapy for chronic fatigue syndrome (more correctly known as ME/CFS).

Cochrane's editor-in-chief admitted the review was not fit for purpose on publication, but it continues to be hosted in the Cochrane Library and cited in scientific journals and clinical guidelines. This is despite government organisations such as the UK's NICE (NG206: 1.11.14) and the USA's CDC having found, following unbiased evaluations, that there is no evidence that exercise therapy is effective for ME/CFS. This is also despite virtually all ME/CFS patient organisations rejecting exercise therapy as a valid treatment of the disease and many people with ME/CFS reporting becoming much sicker after graded exercise therapy.

Also in October 2019, the Cochrane editor-in-chief promised to commission a new review with the process to be a pilot of a new approach, involving an independent advisory group and public consultation. The aim was to complete it in two years. In 2023, not even the first step, a review protocol, has been agreed. There has been no public consultation and none of the promised monthly updates since August 2021.

The Covid-19 pandemic has created even more need for evidence-based assessments of proposed therapies for ME/CFS. Many of the millions of people who are developing Long Covid meet ME/CFS criteria and have the symptom of post-exertional malaise, contraindicating Graded Exercise Therapy.

The committee and members of the international Science for ME forum have written to Cochrane requesting:

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.

AND

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.

The letter has been posted here:
S4ME: 2023 Open Letter to Cochrane - request for action on the ME/CFS Exercise Therapy Review

Please sign this petition to call on Cochrane for action.

The Committee of the Science for ME international forum"
_________________

Some people with ME/CFS or Long Covid, or their carers, have added comments. We hope you will take the time to read all the comments. Here is a small sample:

Laura Stevens
My daughter became ill with ME following glandular fever when she was 9 years old. Knowing no better and on medical advice we forced her to increase activity (GET). She became progressively sicker and I will always carry the guilt of this.

Femke van Hellenberg
This therapie harmed our daughter. Before she could go to school after this therapie she was bed and house bounded.

Anne Brown
I have seen how exercise therapy set my son back, with ME symptoms increasing and lasting longer. I believe if medical advice had been more appropriate and he had been encouraged to properly rest and recuperate he would not have become as poorly as he did and the illness might not still be with him 10 years on. The lived experience of ME/CFS sufferers needs to be listened to and drawn on, and this illness taken seriously.

Sasha Ripley
I was starting to recover about 6 months after getting covid and my doctors all insisted I start exercising again. I followed their advice and became extremely sick and have now been sick and disabled for 1 1/2 years

P J
My health was irreparably damaged by exercise therapy administered by a physiotherapist who was following NHS / NICE guidelines that recommended GET at the time. I am now mostly horizontally bound and relying on a wheelchair to move from bed to other rooms in my home. I am unable to go out, work, enjoy hobbies, or participate in my family and friends' lives. For 15 years now. I went from moderately ill to severely ill just by pushing myself under the instructions of a professional I trusted had my health at heart.
How many more of us need to have our lives destroyed before scientists and medical professionals stand up for actual science?

Jenny Meagher
I was harmed by graded exercise therapy. After GET, my ME became more severe and I could no longer work.

Joelline GIROUARD
As a person who was irreversably harmed by attempting to increase my activity levels despite my body's signals to stop, I feel very strongly that no form or increase of activity should ever be forced on a sufferer of ME/CFS and now the fatigue-dominant presentation of long COVID.
__________________

We look forward to swift action to remedy this untenable situation.
As we said in our initial letter on 31st August: "Cochrane's reputation and, more importantly, the health of millions of people, are at stake."

This letter and any replies we receive will be published on the public Science for ME forum and copied on other media and social media as we consider appropriate.

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

 

We have today sent the following email:

cspencer@cochrane.org
cc
editorinchief@cochrane.org
cochrane.iag@gmail.com
gcleng@doctors.org.uk


___________________

To Catherine Spencer, Chief Executive, Cochrane

cc Karla Soares-Weiser, Editor-in-Chief
Hilda Bastian, Independent Advisory Group leader
Gillian Leng, Cochrane Governing Board member, and formerly Chief Executive of NICE

Dear Catherine Spencer,

re: Cochrane reviews of exercise therapy for CFS, now correctly called ME/CFS.

I write on behalf of the committee of the Science for ME international forum. On August 30th we sent an open letter to Dr Soares-Weiser with copies sent to several other senior Cochrane people and to Hilda Bastian. This letter called for the immediate removal of the 2019 Larun et al review of Exercise Therapy for CFS which was acknowledged by Karla Soares-Weiser as requiring replacement at the time it was published. This flawed review continues to be cited in the development of guidelines for ME/CFS clinical care.

The letter also called for public information about the state of the process for developing a new review to replace it. Cochrane publicised this process as a flagship example of a new approach, with stakeholder involvement and engagement at its core, and a new review to be completed by early 2022. Instead there has been no public communication for two years, and not even a protocol published. Patients suffering from harmful treatment as a result of the flawed 2019 review continuing to be hosted by Cochrane are owed answers and action.

We have sent two further open letters and set up a petition currently signed by over 8000 people in support of our requests. The open letter also has the support of, currently, 40 ME/CFS and Long Covid organisations from around the world.

We do not find Cochrane's reply of 'this review topic is currently undergoing a process led by an Independent Advisory Group' a useful response to the concerns we have expressed. Replies from Cochrane suggest that the person delegated to reply is not aware of the issues involved.

We understand that you have had some correspondence with Caroline Struthers about this increasingly unsatisfactory situation, including concerns that the lack of action is contrary to Cochrane's charitable objects which are primarily about the "protection and preservation of public health". We also understand that Cochrane reviews can be withdrawn if there is evidence that a treatment is ineffective and/or there is evidence of harm. The 2021 NICE ME/CFS evidence review and guideline, undertaken and completed while Gillian Leng headed NICE, documented ineffectiveness and harm from graded exercise therapy for people with ME/CFS.

People with ME/CFS have waited through 4 years of empty promises for the flawed review to be withdrawn by Cochrane. A progress report sometime on a process of unknown duration will not suffice. Suspicion grows of interference in the process, and a complete lack of understanding by Cochrane of the seriousness of the impact of this lack of action.

Can you please provide us with clear answers to the following questions:

1. Will the 2019 Larun review that Dr Soares-Weiser acknowledged was flawed four years ago be removed immediately?

2. If not, why not?

3. Who has the authority and responsibility to remove a Cochrane review that has been shown to be inaccurate and harmful?

4. Do you understand the harm that the ongoing hosting of the 2019 Larun review is causing people with ME/CFS and Long Covid?

5. The planned delivery time of the new review was early 2022. What is the new planned delivery time?

6. We understand Rachel Marshall left Cochrane last year. Who is her replacement as the 'Exercise therapy for ME/CFS' review update project manager?
_______

We look forward to your prompt answers to our questions.

This letter and any replies we receive will be published on the public Science for ME forum and copied on other media and social media as we consider appropriate.

Yours faithfully,
Trish Davis on behalf of the Science for ME committee.

 

We have today received the following email from the Office of the Cochrane Editor in Chief:


Thank you for your email.

The 2019 version of the review has undergone thorough editorial scrutiny and the matter is closed.

For any new concerns about this topic, the process is to pass them to the Independent Advisory Group to inform their work. Please could you confirm if you are happy for us to share this correspondence with them so they can take your requests into consideration?

The Independent Advisory Group is seeking to address questions beyond the scope of the 2019 review, and we hope to share a progress update from them in the coming weeks.

Cochrane does not have the resource to hire project managers for individual reviews. A former member of staff helped to set up the Independent Advisory Group, which is now self-managing.

Kind regards,
Office of the Editor in Chief

 

For completeness, the petition update that was posted on 8 October:

PETITION UPDATE
8 October - Global solidarity

OCT 8, 2023 —

Last week we passed the 4th anniversary of the publication of the flawed 2019 version of the Cochrane review 'Exercise Therapy for CFS' by Larun, Brurberg, Odgaard-Jensen and Price. It is also the 4th anniversary of Dr Karla Soares-Weiser acknowledging that the review is not fit for purpose and committing to a process to deliver a new review in two years.

Four years on, and there is no new review. The flawed one, with its recommendation for Graded Exercise Therapy (GET), still remains. We continue to see the review used to support guidelines recommending GET, we are still seeing people with post-exertional malaise told that GET can cure them. This is despite there being no credible studies finding that GET is useful for ME/CFS and despite authorities such as UK NICE and US CDC, after reviewing the evidence, advising against GET for ME/CFS.

Advocates, often at substantial cost to their health, have actually been pointing out the flaws in this Cochrane review since the first version of the review was published in early 2015. Now, the best part of a decade on, we are hearing rumours of Cochrane 're-starting' the new review process, but the harmful review still remains in place.

Since the last update, seven more ME/CFS organisations have added their support to the campaign:

Japan ME Association
Danish ME Association
Millions Missing Denmark
MECFS Canterbury (New Zealand)
Emerge Australia
#ME Action Scotland
Irish ME/CFS Association

Thank you very much to all of the 41 organisations, from 19 countries as well as international and regional peak bodies, for supporting the open letter. The President of the Japan ME Association noted that her association has been fighting against GET for years, and hopes for immediate action by Cochrane. We, the petition organisers, hope that the demonstration of global solidarity from ME/CFS organisations in this campaign provides some strength to people who feel that they have been fighting against GET for too long on their own.

If you can, please help to promote this petition, and encourage more ME/CFS or Long Covid organisations to support the open letter. Organisations wishing to add their support can contact us at moderators@s4me.info.

You can join the discussion about the campaign on the Science for ME forum, at Petition: S4ME 2023 - Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review. The forum has a range of resources for ME/CFS advocates - it is run entirely by volunteers and membership is free. If you have ME/CFS or advocate for people who do, especially if you live in a country that does not have a national ME/CFS group, the forum is there to support you.

 

And the petition update posted on 18 October:

PETITION UPDATE
18 October 2023: Cochrane's quality control processes are broken

OCT 18, 2023 —

On the 8th October, we sent a letter to Catherine Spencer, Chief Executive of Cochrane. You can find a copy of the letter here.

In the letter, we noted the multiple letters sent in this campaign, as well as the years of effort from advocates. We noted that our arguments have been found to be accurate by agencies such as NICE and the CDC when they have examined the evidence base for exercise therapy for ME/CFS. We noted that the Editor of Cochrane, Dr Soares-Weiser, had acknowledged that the 2019 review required replacement at the time it was published.

We noted this petition with its many testimonies of harm. We noted the, at the time, 40 organisations from all around the world that were supporting the call for the immediate removal of the problematic review.

As of the 18th October, we have had no reply. Advocates have tried in multiple ways over multiple years to engage with Cochrane, and still that review remains in place, propping up clinical guidelines that are simply wrong.

The quality control systems in Cochrane appear to be broken. That is a major problem for an organisation claiming to offer gold-standard information on health care. Cochrane is ignoring the global community of patients and their organisations, it is ignoring credible agencies that also found that exercise therapy does not work. It is ignoring the obvious flaws of the 2019 review, and the obvious flaws of the trials that the review attempted to summarise.

This is despite Cochrane announcing in 2022 that it has a 'bold new framework for consumer engagement and involvement'. Cochrane claims to have a commitment to the implementation of public involvement called "Putting People First". It aimed to have a mechanism to "ensure Cochrane's work in engagement and involvement is evidence based, and to monitor and evaluate the impact of its work". There is little evidence of these aims being anything more than platitudes when it comes to the 2019 Exercise Therapy for CFS Review.

********
Since our last update, another seven organisations have added their names in support of the campaign. Many thanks to these organisations from Norway and Belgium.
ME Foreningen Vestland
ME Foreningen Buskerud
ME Foreningen Troms
ME Foreningen Vest Agder
ME Foreningen Aust Agder
ME Foreningen Vestfold
Millions Missing Belgique

You can find the list of the now 48 ME/CFS and Long Covid organisations supporting the campaign here. If you know of an organisation that might like to support the letter, please contact us or have the organisation contact us at moderators@s4me.info.

 

PETITION UPDATE
22 Oct: The office of the Editor-in-Chief replies

OCT 21, 2023 —

In our letter of 8th October addressed to the Chief Executive of Cochrane, we asked for "clear answers to the following questions:

1. Will the 2019 Larun review that Dr Soares-Weiser acknowledged was flawed four years ago be removed immediately?

2. If not, why not?

3. Who has the authority and responsibility to remove a Cochrane review that has been shown to be inaccurate and harmful?

4. Do you understand the harm that the ongoing hosting of the 2019 Larun review is causing people with ME/CFS and Long Covid?

5. The planned delivery time of the new review was early 2022. What is the new planned delivery time?

6. We understand Rachel Marshall left Cochrane last year. Who is her replacement as the 'Exercise therapy for ME/CFS' review update project manager?"
___________

Science for ME has received the following reply:


"Thank you for your email.

The 2019 version of the review has undergone thorough editorial scrutiny and the matter is closed.

For any new concerns about this topic, the process is to pass them to the Independent Advisory Group to inform their work. Please could you confirm if you are happy for us to share this correspondence with them so they can take your requests into consideration?

The Independent Advisory Group is seeking to address questions beyond the scope of the 2019 review, and we hope to share a progress update from them in the coming weeks.

Cochrane does not have the resource to hire project managers for individual reviews. A former member of staff helped to set up the Independent Advisory Group, which is now self-managing.

Kind regards,
Office of the Editor in Chief"

****
Clearly, as far as the Editor in Chief (Dr Karla Soares-Weiser) is concerned, the 2019 review will not be withdrawn until there is a new one to replace it, however long that takes. This is inconsistent with her statement at the time the 2019 review was published that it was already outdated and would be replaced in two years. Four years on, and it's still there causing harm.

Since 2019, both UK NICE and US CDC have looked at the evidence and concluded that exercise therapy should not be used as treatment for ME/CFS. Hundreds of you have told Cochrane in your comments on this petition that you have been significantly harmed by exercise therapy.

We and other patient organisations, over 50 now, have repeatedly told Cochrane that the treatment does not work and causes harm. We can only conclude that decision makers at Cochrane are more concerned about upsetting the review authors and their friends than the well-being of millions of people and the reputation of their organisation.


The next part of the reply tells us to talk to the new review's Independent Advisory Group (IAG). They even offer to forward our letter to them, having failed to notice that we have copied the IAG in to all our letters.

There are two problems with this.

First, the IAG has not been communicating for two years. We have sent the IAG a number of emails over the last month, and still there has been no reply. We have no idea if the IAG is still functioning, or if Hilda Bastian is still leading it.

Second, the IAG is not Cochrane, it's just an advisory group, and it has no control over what is done with the 2019 review. Even if the IAG was communicating with the ME/CFS community, they can't usefully discuss the removal of the 2019 review.

Cochrane seems to be distancing itself from the new review process, withdrawing editorial support, and passing responsibility for this situation to an advisory group with no teeth that appears not to be able to function as intended.

****
Having observed how many years it took for Cochrane to commit to change on this issue, and then how it has delivered nothing of substance for four years, we have no confidence that an acceptable replacement review will be produced. The flawed 2019 review continues to influence clinical practice, and that must stop.

Petition signatures and comments and organisations supporting the campaign help to demonstrate how strongly the ME/CFS community feels about ensuring medical professionals understand that exercise therapies don't fix ME/CFS. We will keep working on getting the review removed.

Since the last update, five more organisations have brought the total number of organisations supporting the campaign to 54. Thank you very much to:

Norwegian ME-association Oslo og Akershus
RME Skåne (Sweden)
RME Väst (Sweden)
#MillionsMissing Sweden
RME Stockholm (Sweden)

To see the whole list of organisations, click here.

 

LETTER OF COMPLAINT
Today the Science for ME team sent the following letter to the Cochrane Complaint email address:

______________________

To Cochrane Complaints team,

Dear Madam or Sir,

We are writing to make a complaint about the handling post publication of the 2019 review "Exercise therapy for chronic fatigue syndrome" by Larun et al (2,3,4); the lack of timely or substantive response to a comment on it by Michiel Tack (5,6); the handling of the process for its replacement with a new protocol and review (7,9), and the Editor-in-Chief's handling of correspondence (10,14). Given the problems with all of these, our final complaint is about the Editor-in-Chief's intransigence over the policy decision to make the withdrawal of the outdated review contingent on the publication of a new review, regardless of changes in circumstances.

In detailing our complaints we are guided by Cochrane's own descriptors:
"This procedure applies to complaints about the policies, processes, or actions of staff, contributors or position-holders within Cochrane who are involved in the publication or content of the Cochrane Library. "
"We define complaints as an expression of unhappiness about a failure of process or an important misjudgement."(1)

Complaint A: A failure of process - non removal of an outdated and incorrect review in the timescale promised.

This refers to the 2019 Larun review remaining in the Cochrane Library well beyond the promised time for it to be replaced with an updated review. The Editor-in-Chief, Dr Soares-Weiser stated at the time of publication:

"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.”

She added, “By forging better relationships with patients, as well as the groups that represent them and the clinicians who seek to treat them, we can improve the way in which future Cochrane Reviews in this area address important questions and meet patients’ and clinicians’ needs. 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.” (3)
October 2, 2019

Further information was provided on the limitations of the 2019 review and planned timescale for the review's replacement:

"FAQs last updated 30 June 2021

Why is the review being updated and how long will it take?
Cochrane reviews can be updated because a review’s methods or included evidence may be out of date, or in response to concerns. This review is being updated for all those reasons.

Cochrane’s Editor in Chief, Karla Soares-Weiser, considered the range of concerns expressed about this review and concluded the review needs a patient-focused, contemporary perspective on exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The current review approaches the issue with a research question and a set of methods from the early 2000s, reflecting evidence from studies that applied definitions of ME/CFS from the 1990s. In addition, the results of any relevant studies available after May 2014 are not included.

The complete updating process for the review is expected to be complete early in 2022. We will be reporting on progress monthly.

More on this: Cochrane’s statement announcing the amendment and planned update process.

Why was the Cochrane review amended in October 2019?
The amendment aimed to address some of the concerns raised about the review in the short term, pending the lengthier process of a complete update.

The changes to the review related to the limited applicability of the evidence given the definitions of ME/CFS in the studies, long-term effects on fatigue, and limited assessment of potential harms."

It is therefore clear that the Editor-in-Chief intended that the 2019 review only stay in place for two years when it would be replaced by an updated review. As she acknowledged it was already outdated and unsatisfactory at the time of its publication, we contend that Cochrane has a duty to withdraw the outdated review immediately. It is a failure of process not to remove an outdated and inaccurate review on the planned timescale.
___________________

Complaint B: A failure of process - failure to follow normal procedure on a critical comment

From the Complaints Procedure:

"The complaint process exists in parallel with the comments process and may be used either if you believe that the comment is of such a serious nature that urgent corrective action is warranted, or if you believe that the usual process has not been satisfactorily managed or resolved."(1)

We refer to the detailed critical comment (5)
"Problems with the amended version (Version published: 02 October 2019)
Published : 26 August 2020

• Michiel Tack
• Vice-chair of the Belgian patient organisation 12ME

I appreciate the efforts made by Cochrane and the authors to correct some of the errors in the previous version of this review. There are however some major problems that remain and significantly impact the results and conclusion. [...]"
The response from Cochrane, published on the same date, was a brief statement (6)

"Note on the status of this review Published : 26 August 2020
John Hilton, Cochrane Senior Editor
Response from the editorial team at the Cochrane Editorial and Methods Department:
We thank Michiel Tack for the feedback on this review, and we appreciate the thorough and well-referenced comment. This review and its protocol are in the process of being updated as a priority. The update is being informed by an independent advisory group of people living with ME/CFS, clinicians, and researchers. We will ensure that the comments you have provided will be reviewed during the updating process by the independent advisory group and the authors of the review.

Further information about the review update, and reports on progress, will be posted to the following website..."
Michiel Tack's comment details nine substantive problems with the review that are of a serious nature. Urgent action is warranted on the grounds that the review is unsound, and because of the harms resulting from the review remaining in place. (see Complaint E below).

Given that the review has not been updated within the planned timeframe, neither have the issues identified in the Tack comment been addressed and resolved. Therefore, it is clear that the "usual process [for issues raised in comments] has not been satisfactorily managed or resolved

We contend that it is not normal for Cochrane to leave a detailed critical comment unaddressed for over 3 years and the review to remain in place unchanged with no response or reasons given on the substance of the critical comment. This is a clear failure of process by Cochrane.

Further, we are concerned that the points in Michiel Tack's comment may not be adequately addressed in the new review. We are concerned that, from what we have been able to glean of the opaque selection method for membership of the IAG and review writing group, there was undue emphasis on creating 'balance of views' about ME/CFS, rather than focus on selecting people with good understanding both of current diagnostic criteria for ME/CFS, and of clinical trial methodology.

In particular, we draw Cochrane's attention to the importance of Michiel Tack's points on bias due to lack of blinding when reviewers rely only on PROMs which "create a high risk of response- and expectancy bias". This is made worse, as Tack explains, by Larun et al's exclusion of data from objective measures, inclusion of which should be essential in reviews of unblinded trials.
________________

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.

Cochrane set up the process for the new protocol and review in early 2020 (7). The IAG leader was announced in February 2020 (8). Despite planned completion by early 2022, and promise of monthly updates, it took over a year just to appoint the review writing team and members of the IAG, and only 3 monthly updates were published, the last in July 2021 (9) which announced imminent public consultations and a draft protocol in the autumn of 2021. (7)

"A draft protocol will also be available for a brief public consultation period, which is anticipated to be in the third quarter of 2021.

People can communicate directly with the IAG via the email address, Cochrane.IAG@gmail.com. The email account is not monitored by members of Cochrane’s staff. When the IAG finishes its work, the contents of the account will be archived at Cochrane.

In addition to the IAG itself, the IAG lead will convene an email discussion group for groups representing people living with ME/CFS. The IAG lead, in consultation with other participants, will also develop other opportunities for stakeholder engagement." June 2021

No further updates have been published, there has been no public consultation, and no draft protocol. There have been no replies to emails sent to the IAG email address address since August 2021 as far as we are aware (11). Cochrane managers have failed to intervene effectively, or possibly at all, to set the process back on track.

We would expect a professional organisation that sets up a process with an announced timeline and appointed roles for individuals, including patient and carer volunteers, to be run professionally and overseen by senior staff to ensure it maintains the promised progress and promised regular updates.

It must have been clear to the Editor-in-Chief two years ago that the process had faltered, yet no effective action was taken to put the process back on track, with, if necessary, temporary or permanent replacement of key people if they were no longer able to maintain the momentum of the work they were contracted to do.

This is clearly a major failure of 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.

On 28th August 2023 and several subsequent dates, the Committee of the Science for ME international forum wrote to the Editor-in-Chief with detailed requests and expressions of concern about both the continued presence of the outdated 2019 review long past the time it should have been replaced, and about the lack of progress and communication on the new review. (10)

"Dear Dr Soares-Weiser,

We are writing to you to request that you take urgent action on the following. The reasons are set out below.

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.

AND

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.
[...]"

The only replies we have received to a series of letters we sent to various senior people at Cochrane have been two brief emails from 'the office of the Editor-in-Chief' (14) telling us that the IAG has resumed work after 'an unplannned hiatus', the subject of the 2019 review is closed, and telling us to address our concerns to the IAG.

As described in Complaint C, the IAG email facility and the IAG itself appear not to have functioned for two years. Redirecting our concerns to the IAG is wholly inappropriate, since the IAG is not responding to any correspondence, and has no power over what happens to the 2019 review.

Since we have been unsuccessful in contacting the IAG via its email address, we tried contacting a couple of members of the IAG for an update, but were told they have signed a non-disclosure agreement. It is clearly inappropriate to ask us to communicate with a group who have been forced to sign agreements that they will not communicate with us.

Given that the 'in a few weeks' mantra has been used repeatedly for over two years, when any response could be elicited at all, we have no reason to trust that it is true this time. (11)

The message is clear, the Editor-in-Chief and Cochrane, far from being keen to run a good pilot of public involvement in a review, have washed their hands of a dismal failure. We note that the Editor-in-Chief was not prepared to sign her name to the two brief emails we have received from her office. Dr Soares-Weiser appears to take no responsibility for ensuring that a process that she set up actually functions, and is now unwilling to enter any communication from concerned citizens, even when over 50 organisations worldwide (12) and over 9000 individuals (13) have signed in support of our requests.
This is a major failure of process and judgement.
___________________

Complaint E: An important policy misjudgement - making the withdrawal of the 2019 review contingent on the publication of a new review.

In our letter of 8th October (10), we asked:

"1. Will the 2019 Larun review that Dr Soares-Weiser acknowledged was flawed four years ago be removed immediately?

2. If not, why not?

3. Who has the authority and responsibility to remove a Cochrane review that has been shown to be inaccurate and harmful?

4. Do you understand the harm that the ongoing hosting of the 2019 Larun review is causing people with ME/CFS and Long Covid?"

In the reply of 19th October from the Office of the Editor-in-Chief (14) the response to these questions was:

"The 2019 version of the review has undergone thorough editorial scrutiny and the matter is closed.

For any new concerns about this topic, the process is to pass them to the Independent Advisory Group to inform their work. Please could you confirm if you are happy for us to share this correspondence with them so they can take your requests into consideration?

The Independent Advisory Group is seeking to address questions beyond the scope of the 2019 review, and we hope to share a progress update from them in the coming weeks."

While we accept the Editor-in-Chief allowed the 2019 Larun et al review to be published in 2019 as a temporary measure, we cannot accept that the matter is closed four years later when circumstances have changed. Dr Soares-Weiser acknowledged herself that the review was based on an outdated protocol and incomplete data.

Since its publication, both Michiel Tack's critical comment (5) and the evidence reviews by the CDC (18) and NICE (17) demonstrate clearly that the 2019 review is scientifically unsound. The impact of this new scientific evidence should lead to withdrawal of the old review regardless of when and indeed whether the new review is completed. The failure of the process to produce the new review should not be used as a delaying tactic to keep the old review in place.

We are also concerned that in making this decision to keep the 2019 review for an indefinite time into the future, Dr Soares-Weiser has not taken into account the evidence of the harms that recommendation of exercise therapy causes to people diagnosed under current definitions of CFS or ME/CFS, as evidenced in multiple surveys of thousands of people with ME/CFS. Current definitions of ME/CFS require post-exertional malaise, not just fatigue after exercise. PEM, commonly referred to as a 'crash' is a significant worsening of symptoms and loss of function for days, weeks or longer after small increases in activity. Keeping the Larun review in the Cochrane library will undoubtedly lead to further harm.

We ask Cochrane to review whether it is correct procedure under your rules to keep an outdated and scientifically incorrect review current in the Cochrane library until a replacement is published, regardless of how long that takes, and how outdated, inaccurate and harmful the advice in the review is to patients.

Finally, we ask Cochrane to consider in whose interests it is to keep the outdated review? Clearly it is not in the interests of science or patients, nor is it in the interests of either its author group who have stepped away and expected it to be gone by now, or the IAG and new review authors on whom it adds pressure to complete the badly stalled process.

As we said in our latest petition update (13):

"We and other patient organisations, over 50 now, have repeatedly told Cochrane that the treatment does not work and causes harm. We can only conclude that decision makers at Cochrane are more concerned about upsetting the review authors and their friends than the well-being of millions of people and the reputation of their organisation."
___________________

Thank you for your consideration of these complaints.

We ask you to note that if the IAG resumes its regular updates in the next few weeks, that will not resolve any of our complaints, since the process of completing and taking the new review to publication, if it ever happens, will take many more months, if not years, while the old review remains and continues to provide the potential for ongoing harm to millions of people with ME/CFS.

Please note that we intend to publish this complaint and any responses we receive in full on our public forum.

We look forward to your considered response to these complaints.

Yours faithfully,

Trish Davis on behalf of the Committee of Science for ME international forum.
____________________

References - see next post

____________________

 

PETITION UPDATE
Complaints to Cochrane

Christchurch, New Zealand
OCT 31, 2023 —

Cochrane has a system whereby complaints, defined as 'an expression of unhappiness about a failure of process or an important misjudgement' are accepted and are responded to.

Today, the Science for ME committee sent formal complaints to Cochrane. The document can be found here and covers the following topics:

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Complaint A: A failure of process - no removal of an outdated and incorrect review in the time frame promised.

We linked to the Editor-in-Chief's own statement that made clear that the 2019 review was to only stay in place for two years, when it would be replaced by an updated review.
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Complaint B: A failure of process - failure to follow normal procedure on a critical comment

Cochrane has a facility where comments can be posted about reviews. In August 2020 Michiel Tack notified Cochrane of nine major problems with the Larun et al 2019 review. A Cochrane Senior Editor acknowledged the comment, saying that the review was 'in the process of being updated as a priority'. Lack of progress on the new review leaves the nine problems unaddressed for over 3 years to date, and the flawed review in place unchanged.
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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.

Cochrane set up the process for the new protocol and review in early 2020 with planned publication of the new review in early 2022. We spell out the two years of broken promises on regular updates, public consultation and the lack of response from the IAG email address. Cochrane managers have failed to intervene effectively, or possibly at all, to set the process back on track.
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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.

We inform the complaints department of our letters to Cochrane starting on 28th August 2023, this petition, and the brief and unsatisfactory replies from the office of the Editor-in-Chief. We point out that redirecting our concerns to the IAG is wholly inappropriate, since the IAG is not responding to any correspondence, and has no power over what happens to the 2019 review. We conclude that Dr Soares-Weiser, the Editor-in-Chief's unwillingness to take responsibility is a major failure of process and judgement.
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Complaint E: An important policy misjudgement - making the withdrawal of the 2019 review contingent on the publication of a new review.

We cannot accept the Editor-in-Chief's judgement that the question of withdrawal of the 2019 review is closed four years after its temporary publication when circumstances have changed. We highlight more up-to-date evidence reviews by NICE and the CDC which do not support the conclusions of the 2019 Cochrane review, and spell out harms from the review remaining. We say that failure of the process to produce the new review should not be used as a delaying tactic to keep the old review in place. We asked Cochrane to consider in whose interests it is to keep the outdated review? Clearly it is not in the interests of science or patients.
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We noted that if the IAG resumes its regular updates in the next few weeks, that will not resolve any of our complaints, since the process of completing and taking the new review to publication, if it ever happens, will take many more months, if not years, while the old review remains and continues to harm people with ME/CFS.

We will keep you updated about Cochrane's response.





THANKS

Thank you very much to Trish Davis for her great work putting the complaints document together.

Thank you also to the five organisations who have added their names to the now 59 organisations who are supporting the campaign since the last update. You can find the full list here. If an organisation you are associated with isn't listed there, please ask them to add their name - they can contact us at moderators@s4me.info.

RME Jönköping - Sweden

ONG PEM - Spain

ME Support New Zealand

LocalME - comprises 52 local support and advocacy groups across the UK as well as outside UK

MillionsMissingHolland

Thank you also to David Tuller for his coverage of the campaign and to everyone who has signed and shared the petition.

The Science for ME committee

 

PETITION UPDATE

The call from patient organisations grows stronger - Cochrane continues to show no sign of listening

NOV 8, 2023

Five more organisations add their support to the campaign

Thank you very much to the following five organisations for supporting the campaign, bringing the number of organisations to 64.

Germany - Lost Voices Stiftung
Italy - CFS/ME Associazione Italiana
Netherlands - Steungroep ME en Arbeidsongeschiktheid
Italy - CFS/ME Organizzazione di Volontariato
United States - Long Covid Families

You can find the full list here. If an organisation you are associated with isn't listed there, please ask them to support the campaign - they can contact us at moderators@s4me.info.

Please continue to share the petition to help get to 10,000 signatures.



No response yet to the formal complaint to Cochrane

We sent the formal complaint to Cochrane on 31 October. Cochrane's complaint process says that it will acknowledge receipt of complaints within three days. More than a week later, there has been no acknowledgement.

Cochrane's complaint process also says that it will respond to the complaint within two weeks. We wait for the response.



No news on the planned new review
On 29th September 2023 'the office of the Editor-in-Chief' told us: "A first report and project website update is planned for release in the next few weeks." Six weeks on, there is still no news. We have been told to send our concerns to the Independent Advisory Group, but they are still not responding. Even if the process towards a new review resumes immediately, it could take years to produce a new review. There is no guarantee that it will ever be completed or that it will be any better than the old review.

Any reasonable person would see that a review that the Cochrane Editor-in-Chief stated was out of date on publication four years ago, with findings that have been declared wrong by NICE and the CDC, and that over 60 informed consumer organisations from 18 countries have said is harmful, must be withdrawn immediately. While it continues to be hosted by Cochrane and cited, people continue to be harmed.

So, this petition is as important as ever. It will remain open until Cochrane no longer hosts a scientifically inaccurate and harmful review recommending exercise therapy for people with ME/CFS.

Karla Soares-Weiser, Editor-in-Chief at Cochrane, and the Editorial Board: the values that Cochrane says it stands for requires that the 2019 review be withdrawn immediately. Please withdraw the 2019 review.