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).

The PACE trial
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 methodologicalgrounds. 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
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."

Keith Geraghty
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
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
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
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
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
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
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
Sharpe also requested the retraction or correction of Professor Steven Lubet's article How a study about Chronic Fatigue Syndrome was doctored, adding to pain and stigma.

Journal of health psychology
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
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
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.

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 * *2012, Letter from Countess Mar to Professor Simon Wessely