Intimidation and bullying of PACE trial critics
Intimidation and pressure to silence debate has been reported by researchers, clinicians and patients after criticizing the PACE trial, a large randomized trial on behavioral interventions in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This includes emails and phone calls to the critics’ home institution and superiors, demands for a retraction of articles critical of PACE and complaints to the UK's Royal College of General Practitioners (RCGP).
- 1 Background
- 2 Testimonials and other examples
- 3 Learn more
- 4 See also
- 5 References
Background[edit | edit source]
The PACE trial[edit | edit source]
The PACE trial was a large randomized trial to test the efficacy and safety of several behavioral interventions including cognitive behavioral therapy (CBT) and graded exercise therapy (GET) in ME/CFS patients. Since the start of the trial in 2003, PACE has been criticized on methodological grounds. Criticism includes invalid selection criteria,ceiling effects in outcome measurements, violation of the declaration of Helsinki regarding Good Clinical Practice, and deviation from the trials protocol without providing sensitivity analyses.
Negative portrayal of PACE critics[edit | edit source]
Patients and scientists have requested anonymised data from the PACE trial through Freedom of Information Requests and other means, to compare the reported findings to the original protocol-specified procedures. Several of these requests have approved by the Information Commissioner's Office - despite been rejected and labeled “vexatious” by the PACE authors’ academic institutions.
Richard Horton, editor-in-chief of The Lancet, the scientific journal that published the PACE trial main findings, described critics of PACE as “a fairly small but highly organized, very vocal and very damaging group of individuals who have ... actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients.”
Critics of the PACE trial have repeatedly been compared to climate change deniers and anti-vaccination campaigners. Professor of neurology Malcolm Macleod for example said: "If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…”
Patients that were critical of the PACE trial have been targeted by an extended smear campaign that variously portrayed them as violent militants or activists engaging in a campaign of harassment. During the 2015 first tribunal hearing on the release of the PACE trial data, professor Ross Anderson made “wild speculations” about “young men, borderline sociopathic or psychopathic” being attached to PACE trial criticism.
Authors of a reanalysis of the PACE trial received an abusive review at the British Medical Journal. One of the peer reviewers wrote: "It is about time that they moved on from their obsessive (in the non-psychiatric use of the term) poring over the results of a good (albeit imperfect) randomised controlled trial." The peer reviewer also questioned the diagnosis of some of the authors and their sincerity in criticizing the PACE trial: "Are [the patient authors] absolutely sure that they are writing about syndromes of chronic fatigue? Are they sure they are not simply writing about themselves?"
Scientists and clinicians who expressed concern about the safety of interventions used in the PACE trial were demeaned on social media as "whiners" who "have managed to ensure there is no treatment available for patients with ME." Critics of the PACE trial have been accused of disliking the results and attempting "to find faults with them which would not be raised if they liked the results."
Testimonials and other examples[edit | edit source]
Keith Geraghty[edit | edit source]
Keith Geraghty: "...after I published articles that were critical of the PACE trial, two of the PACE authors W&S lodged complaints about me and my work to my host University. Emails and phone calls to ones bosses is very intimidating." — "... within weeks [of requesting access to PACE trial data], a complaint was made to my home institution, the University of Manchester - from Prof. Peter White, stating I was acting in a highly unprofessional manner."
Emma Reinhold[edit | edit source]
Dr Emma Reinhold: "I tweeted that I hoped PACE would be discredited and tagged Ben Goldacre, not knowing his connection with Simon Wessely. Within 3 days Simon Wessely followed me on Twitter. His wife sent me a facebook friend request and the RCGP said they had received 'complaints' and were considering cancelling the EDS Spotlight project (which I had just been appointed to run but had not received a contract at that stage) to produce the EDS toolkit for GPs. We were told by RCGP we couldn't mention fatigue in the context of EDS. We refused to comply as this is contrary to the evidence."
Jonathan Edwards[edit | edit source]
According to Professor Jonathan Edwards "If you criticize PACE in the UK, there is a quiet phone call to your employer and the next morning you are asked to a meeting to reconsider your contract. I get emails from people to whom this has happened. The only reason why I am the only UK academic to call out on PACE is that I am retired so do not have an employer."
James Coyne[edit | edit source]
Professor James Coyne: "I have a better record of quality and quantity of publications than any of the #PACE investigators but they somehow found me unqualified to write or review papers related to the trial. They even challenged my competence to analyze the trial data when I requested it." "Professor Michael Sharpe filed a @COPE complaint concerning J Health Psych allowing me to review his commentary on #PACEgate, citing my request for the PACE data as demonstrating bias and undeclared conflict of interest." When Coyne criticized the PACE trial on his blog hosted by PLOS ONE, the PACE authors pressured PLOS ONE to forbid him from writing any further articles on the topic. According to Coyne, when he revealed this to a journalist, PLOS ONE responded by abruptly blocking him from posting altogether.
Caroline Struthers[edit | edit source]
Caroline Struthers: "I was intimidated and upset when Larun wrote to my boss to complain about me when I posted @julierehmeyer's article on my personal FB page."Lillebeth Larun is author of the Cochrane review of exercise therapy for chronic fatigue syndrome (CFS). Struthers had posted Rehmeyer's Stat article Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back.
Carol Monaghan, MP[edit | edit source]
During a UK parliamentary debate on myalgic encephalomyelitis (ME) and the PACE trial, Carol Monaghan revealed that Professor Sharpe had written to tell her that her behavior was unbecoming of an MP.
Julie Rehmeyer[edit | edit source]
Professor Michael Sharpe attempted to obtain a retraction or correction of the article by Julie Rehmeyer several years after it was published, falsely claiming the article suggested he was involved in "fraudulent research".
Steven Lubet[edit | edit source]
Journal of health psychology[edit | edit source]
An attempt was made to block publication of a Journal of Health Psychology, Special Issue: The PACE Trial by claiming that it had not been peer reviewed.
David Tuller[edit | edit source]
Professor Esther Crawley, who is a proponent of the PACE trial but was not involved in the running of it, has attempted to silence and intimidate David Tuller, including referring to "libellous blogs" and "fake anti science" in a professional presentation while showing an image of the Virology blog he writes on, and incorrectly claiming he has been sent a "Cease and Desist" letter by the University of Bristol. When Tuller contacted Professor Crawley asking what statements were incorrect, and offering to change anything that was untrue, she did not respond.
Countess Margaret of Mar[edit | edit source]
In 2012, an interview with Simon Wessely was published by The Independent which named the Countess of Mar as "an opponent" of Wessely’s, and stated "he told how he had been harassed, stalked and intimidated by fanatical lobby groups that disputed his the findings", she responded with an open letter to Simon Wessely denying she had ever harassed him, and describing a catalogue of harassment and rude behavior he had subjected her to. Simon Wessely, whose interview was shortly followed by a letter signed by 27 researchers in support, replied to the Countess denying the specific harassment she had described. Prof. Peter White who signed the letter in support of Simon Wessely later apologized.
Learn more[edit | edit source]
See also[edit | edit source]
References[edit | edit source]
- Geraghty, Dr Keith (Feb 20, 2019). "Dr Keith Geraghty on Twitter". Twitter. @keithgeraghty. 1:44 AM. Retrieved Feb 20, 2019.
For the record this morning, after I published articles that were critical of the PACE trial, two of the PACE authors W&S lodged complaints about me and my work to my host University. Emails and phone calls to ones bosses is very intimidating.
- "Chronic fatigue syndrome, Bristol University, and controversial science". The Bristol Cable. Jul 7, 2017. Retrieved Feb 20, 2019.
But if there is truth in the criticisms from patients and CFS advocacy groups and charities, the dominance of the ‘extremist’ opponent narrative – the alleged harassment and abuse of researchers into these treatments – is also troubling. While accepting there may be some intemperate opponents, some critics of PACE and the following trials pursuing similar hypotheses, such as FITNET and MAGENTA at Bristol, say researchers are using the ‘militant’ narrative to deflect legitimate criticisms of bad science.
- Reinhold, Emma (Feb 20, 2019). "Dr. E Reinhold". Twitter. @DrEReinhold. Retrieved Feb 20, 2019.
I tweeted that I hoped PACE would be discredited and tagged ben goldacre, not knowing his connection with SW. Within 3 days SW followed me on Twitter. His wife sent me a FB friend request and the RCGP said they had received 'complaints' and were considering cancelling the...—... EDS Spotlight project (which I had just been appointed to run but had not received a contract at that stage) to produce the EDS toolkit for GPs. We were told by RCGP we couldn't mention fatigue in the context of EDS. We refused to comply as this is contrary to the evidence.
- Edwards, Jonathan (Aug 16, 2017). "ME/CFS News Quotes Jonathan Edwards on Twitter". Twitter. @MECFSNews. 2:47 AM. Retrieved Feb 20, 2019.
Prof. Edwards: if you criticize the #pacetrial in the UK you risk your job.
- Coyne, James C. Coyne (Feb 20, 2019). "James C. Coyne on Twitter". @CoyneoftheRealm. @CoyneoftheRealm. 1:09PM. Retrieved Feb 20, 2019.
#PACE investigators insisted would be conflict of interest for me to blog about #PACEtrial if my request for data still active. So I was blocked from either posting or revealing prohibition. @PLOSblogs made untrue statement my blog was ending due to inability to monitor COI —I encourage @PLOSONE Senior Editor Joerg Heber @joergheber to correct the record with his verison of events concerning @PLOSblog Mind the Brain.
- Struthers, Caroline (Feb 19, 2019). "Caroline Struthers on Twitter". Twitter. @Good_Reports. 7:58 AM. Retrieved Feb 20, 2019.
What about @cochranecollab 's "duty of care" to its patient advocate contributors? I was intimidated and upset when Larun wrote to my boss to complain about me when I posted @julierehmeyer's article on my personal FB page. Yet Larun, as an author, is being protected by Cochrane.
- Walwyn, Rebecca; DeCesare, Julia C.; Chalder, Trudie; Sharpe, Michael C.; White, Peter D. (Dec 2007). "Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy". BMC Neurology. doi:10.1186/1471-2377-7-6/comments. Retrieved Feb 21, 2019.
- Margaret Williams. Critical considerations. 1 st November 2004
- Jason, Leonard A. (Aug 2017). "The PACE trial missteps on pacing and patient selection". Journal of Health Psychology. 22 (9): 1141–1145. doi:10.1177/1359105317695801. ISSN 1461-7277. PMID 28805518.
- "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study". www.virology.ws. Oct 21, 2015. Retrieved Feb 21, 2019.
- Goudsmit, Ellen; Howes, Sandra (Aug 2017). "Bias, misleading information and lack of respect for alternative views have distorted perceptions of myalgic encephalomyelitis/chronic fatigue syndrome and its treatment". Journal of Health Psychology. 22 (9): 1159–1167. doi:10.1177/1359105317707216. ISSN 1461-7277. PMID 28805527.
- "How bad science misled chronic fatigue syndrome patients". STAT. Sep 21, 2016. Retrieved Feb 21, 2019.
- Anderssen, Alex (Oct 21, 2015). "David Tuller Tears Apart PACE Trial". #MEAction. Retrieved Feb 21, 2019.
- Wilshire, Carolyn E.; Kindlon, Tom; Courtney, Robert; Matthees, Alem; Tuller, David; Geraghty, Keith; Levin, Bruce (Mar 22, 2018). "Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT". BMC Psychology. 6. doi:10.1186/s40359-018-0218-3. ISSN 2050-7283. PMC . PMID 29562932.
- peterkempblog (Sep 10, 2016). "PACE Trial Participants – were they exploited?". peterkempblog. Retrieved Feb 21, 2019.
- ""Vexatious": King's College London dismisses James Coyne's request for PLOS One PACE data". #MEAction. Dec 12, 2015. Retrieved Feb 21, 2019.
- "Raw 6mwt Data after treatment - a Freedom of Information request to Queen Mary University of London". WhatDoTheyKnow. Nov 1, 2015. Retrieved Feb 21, 2019.
- "Fitness data for PACE trial - a Freedom of Information request to Queen Mary University of London". WhatDoTheyKnow. Jun 29, 2015. Retrieved Feb 21, 2019.
- "A request for data from the PACE trial". www.virology.ws. Dec 17, 2015. Retrieved Feb 21, 2019.
- "Comparison of treatments for chronic fatigue syndrome - the PACE trial". Radio National. Apr 15, 2011. Retrieved Feb 21, 2019.
- Fiona Fox. (2017, September 28) Inconvenient truths. Science Media Center.
- "Trial by Error, Guest Post: Questions About Professor Sharpe's 'Special Ethics Seminar'". www.virology.ws. Retrieved Feb 20, 2019.
- Lewandowsky, Stephan; Bishop, Dorothy (Jan 28, 2016). "Research integrity: Don't let transparency damage science". Nature News. 529 (7587): 459. doi:10.1038/529459a.
- "expert reaction to Journal of Health Psychology's Special Issue on The PACE Trial | Science Media Centre". Retrieved Feb 21, 2019.
- Anderssen, Alex (Aug 16, 2016). "Tribunal orders release of PACE data". #MEAction. Retrieved Feb 21, 2019.
- Gallagher, Paul (Aug 19, 2016). "Chronic Fatigue Syndrome: tribunal orders data from controversial trial to be released". inews.co.uk. Retrieved Feb 21, 2019.
- Coyne, James C. (May 11, 2017). "Patients writing about their health condition were abused by a peer reviewer and silenced by The BMJ". Quick Thoughts. Retrieved Feb 21, 2019.
- Blanchflower, Danny (Jan 25, 2019). "the whiners have managed to ensure there is no treatment available for patients with ME - brilliant". Twitter. Retrieved Feb 21, 2019.
- Howard, Robert (Feb 6, 2019). ""When people don't like the results of clinical trials they are prone to try and find fault with them". Exactly. I stand with my colleagues who conducted the PACE trial.@ProfRobHoward". Twitter. Retrieved Feb 21, 2019.
- "expert reaction to letter from the HRA to Norman Lamb regarding the S&T Committee's inquiry on Research Integrity and the PACE trial | Science Media Centre". Retrieved Feb 21, 2019.
- "Petition: Opposing MEGA". Phoenix Rising ME / CFS Forums. Retrieved Feb 20, 2019.
- Coyne, James C (Feb 18, 2019). "Prof. James C. Coyne on Twitter". Twitter. @CoyneoftheRealm. Retrieved Feb 20, 2019.
I have a better record of quality and quantity of publications than any of the #PACE investigators but they somehow found me unqualified to write or review papers related to the trial. They even challenged my competence to analyze the trial data when I requested it
- Coyne, James C. (Feb 20, 2019). "James C. Coyne on Twitter". Twitter. @CoyneoftheRealm. 1:01 PM. Retrieved Feb 20, 2019.
I pushed @plosone to let me reveal that I was not being allowed to post about #PACEtrial. When I hinted this to journalists after 2 years, @PLOSblogs abruptly blocked me from posting altogether. @PLOS caved to #PACE investigators and gave up its lead in #datasharing.
- Rehmeyer, Julie (Sep 21, 2016). "How bad science misled chronic fatigue syndrome patients". STAT. Retrieved Feb 20, 2019.
- "Parliamentlive.tv". parliamentlive.tv. Retrieved Feb 20, 2019.
- Tuller, David. "Trial By Error: Professor Sharpe's Retraction Requests". Virology blog. Retrieved Feb 20, 2019.
- Lubet, Steven. "How a study about Chronic Fatigue Syndrome was doctored, adding to pain and stigma". The Conversation. Retrieved Feb 20, 2019.
- Marks, David F (Jul 31, 2017). "Journal of Health Psychology - Volume 22, Number 9, Aug 01, 2017". journals.sagepub.com. pp. 1103–1105. Retrieved Feb 20, 2019.
- Gallagher, Paul (Aug 1, 2017). "'You're a disgusting old fart neoliberal hypocrite' – scientists in furious row over ME study". inews.co.uk. Retrieved Feb 20, 2019.
There was a last ditch attempt to block publication of the special issue by a powerful but unknown PACE trial advocate… A weaselly coward suggested papers weren’t properly peer reviewed and that the special issue should therefore not be published. That of course was nonsense
- Coyne, James C. (2017). "Last ditch attempt to block publication of the Special Issue of the Journal of Health Psychology foiled". Coyne of the Realm.
- "Trial By Error: The Crawley Chronicles, Continued". www.virology.ws. Retrieved Feb 20, 2019.
- Tuller, David (May 3, 2015). "Trial By Error, Continued: My Libelous Blogging on Virology Blog". Virology blog. Retrieved Feb 28, 2019.
- Geraghty, Keith (Apr 28, 2017). "@davidtuller1 blog listed under fake anti science slide - disgraceful". twitter. Retrieved Feb 28, 2019.
- Manning, Sanchez (Nov 25, 2012). "ME: bitterest row yet in a long saga". The Independent. Retrieved Mar 1, 2019.
Professor Wessely has previously come under fire for research he jointly conducted which concluded that cognitive behavioural therapy could be beneficial in treating ME. In August last year he told how he had been harassed, stalked and intimidated by fanatical lobby groups that disputed his the findings.
- Margaret of Mar, 31st Countess of Mar (Dec 4, 2012). "Letter from Countess Mar to Simon Wessely". Invest in ME Research. Retrieved Aug 29, 2018.
- White, Peter; Sharpe, Michael; Crawley, Esther; Holgate, Stephen (Dec 2, 2012). "Letters, emails & online postings". The Independent. Rona Moss-Morris, Charlotte Feinmann Hugo Critchley, Brian Angus, Steven Reid, Patrick Doherty, Paul Little, Maurice Murphy, Tim Peto, Mansel Aylward, Alastair Miller, Diane Cox, Jonathan Sterne, Margaret May George Davey-Smith, Jade Thai, Gabrielle Murphy, Hazel O'Dowd, Brian Marien, Selwyn Richards, Alison Wearden, and Trudie Chalder. The Independent on Sunday. Retrieved Mar 1, 2019.
So it is with sadness that we read in The Independent on Sunday reports of false allegations made against Simon Wessely - one of the few UK clinicians with a specialist interest in treating CFS/ME and someone who has done pioneering research in the field. Ironically, it was because of accusations like this that Professor Wessely received the award in the first place.
Myalgic encephalomyelitis or chronic fatigue syndrome, often used when both illnesses are considered the same.
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