The study compared standardised specialist medical care (SMC) alone to SMC plus Adaptive Pacing Therapy (APT), Cognitive Behavioral Therapy (CBT), or Graded Exercise Therapy (GET). The experimenters hypothesised that the CBT and GET groups would do best, and reported that this is what the trial's results showed but the claim has proved controversial.
- 1 Background
- 2 Study design
- 3 Findings
- 4 Impact
- 5 Criticisms of the study
- 6 Response to criticism
- 7 Controversy
- 7.1 Prof Malcolm Hooper's complaints
- 7.2 Major Investigation by Investigative journalist and academic in public health & journalism - Dr David Tuller
- 7.3 Scientists' open letter to The Lancet
- 7.4 Petitions and Protests
- 7.5 Allegations of harassment
- 7.6 Breaches of patient's data security by study investigators
- 7.7 Other major investigations and reports
- 7.8 PACE Trial in Parliament
- 8 Calls to release data
- 9 Release of Data
- 10 Responses by Scientific Journals and Medical Guidelines
- 11 Quotes from PACE trial critics
- 11.1 Vincent Racaniello
- 11.2 Trevor Butterworth
- 11.3 Professor James Coyne
- 11.4 Professors James Coyne and Keith Laws
- 11.5 Professor Ronald Davis
- 11.6 Emeritus Professor Jonathan Edwards
- 11.7 Professor Rebecca Goldin
- 11.8 Dr Ellen Goudsmit
- 11.9 Professor Leonard Jason
- 11.10 Professor Bruce Levin
- 11.11 Professor Arthur Reingold
- 11.12 Dr. Charles Shepherd
- 11.13 Dr David Tuller
- 11.14 Dr David Tuller and Julie Rehmeyer
- 11.15 Julie Rehmeyer
- 11.16 Dr Michael VanElzakker
- 12 Analysis by "citizen-scientists"
- 13 Principal investigators and researchers
- 14 List of PACE trial publications
- 14.1 2003: Trial Registry. BioMed Central. ISRCTN54285094
- 14.2 2006: Final protocol version 5.0
- 14.3 2007: PACE trial protocol
- 14.4 2011: Main trial outcomes
- 14.5 2012: Cost-effectiveness of CBT and GET
- 14.6 2013: "Recovery" rates
- 14.7 2013: Statistical analysis plan
- 14.8 2014: Adverse effects
- 14.9 2015: Secondary mediation analysis
- 14.10 2015: Long-term follow-up
- 14.11 2015: Longitudinal mediation analysis
- 14.12 Other publications
- 15 Talks & interviews
- 16 Learn more
- 17 See also
- 18 References
The PACE trial was funded by the UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and - apparently uniquely for a clinical trial - the Department for Work and Pensions. It cost £5 million and is the most expensive piece of research into ME/CFS ever conducted.
Recruitment of patients began in March 2005 and data collection was completed in January 2010. The study protocol was published in BMC Neurology in 2007. The main study outcomes were published in The Lancet in 2011 and the experimenters continue to publish papers on the trial. 
The principal investigators were Professors Peter White, Trudie Chalder, and Michael Sharpe. Although not an author, Professor Simon Wessely provided feedback on their report. He stated in November 2015 that "there are also more trials in the pipeline".
641 patients were randomised into four groups in the study. All received specialist medical care (SMC), which consisted of medication for symptoms such as insomnia and pain, and general advice to avoid extremes of rest and inactivity. One group received SMC alone. Patients in another group additionally received adaptive pacing therapy (APT), and were advised to stay within the limits of activity imposed by the disease to give their bodies the best chance of recovery. The other two groups were both told that they were not ill but deconditioned, and that if they gradually increased their activity, there was nothing to prevent their recovery. The cognitive behavioural therapy (CBT) group focused on addressing their presumed fear of activity while the graded exercise (GET) group focused on increasing their activity in a structured manner, with regular aerobic exercise as the eventual goal.
Patients in the APT, CBT and GET groups were offered up to 14 sessions with a therapist over a six-month period, to support them in following their therapy programmes, with a top-up session at 36 weeks. They also received a lengthy manual explaining their therapy. All participants were offered at least three sessions of SMC.
Patients were assessed at baseline, 12 weeks, 24 weeks and 52 weeks. The main outcome measures were self-rated fatigue and physical function. Secondary measures included the study's objective variables such as a six-minute walking test, a fitness test and economic measures including the number of days of work lost due to fatigue, and the receipt of sickness benefits.
Patients were also followed up (using subjective ratings only) at least two years after randomisation.
The trial's results showed that patients in the CBT and GET groups improved more in self-rated fatigue and physical function than the APT or SMC-only groups. Apart from the GET group improving slightly more than the others on the six-minute walking test, all of the study's objective measures and the long-term follow-up data (self-ratings of fatigue and physical function) showed no difference between groups.
The authors reported, in a 2013 paper specifically about recovery, that 22% of patients in the CBT and GET groups had recovered following these therapies, compared to 8% in the APT group and 7% in the SMC-only group.
The PACE trial and other studies that use the Oxford criteria for diagnosis of ME/CFS have had major international impact on popular perceptions of the disease and also on public policies toward treating and researching it.
On February 27, 2011, when the first PACE trial paper was published, researchers Michael Sharpe and Trudie Chalder held a press conference to discuss their findings. Chalder stated, “twice as many people on graded exercise therapy and cognitive behaviour therapy got back to normal.” That assertion has been criticized for grossly overstating the study's actual findings.
The claims made about the study were covered in the UK and international press. For example, The Daily Mail stated, "Fatigued patients who go out and exercise have best hope of recovery", while The New York Times declared "Psychotherapy Eases Chronic Fatigue Syndrome". According to the British Medical Journal's report on the trial, some participants were "cured."
Many other PACE papers followed, although with relatively little media attention until October 2015, when long-term follow-up results were published in The Lancet Psychiatry.     The Daily Telegraph ran a front-page story with the headline, "Exercise and positivity can overcome ME." The piece stated, "Chronic Fatigue Syndrome is not actually a chronic illness and sufferers can overcome symptoms by increasing exercise and thinking positively, Oxford University has found". The article quoted Professor Sharpe describing ME as a “self-fulfilling prophesy” that happens when patients live within their limits. The article was altered following public pressure but no formal retraction was made. Science also published an article in October 2015 along with comments from Sharpe about the growing criticism outwith the patient community from the broader science community.
In the UK the Science Media Centre is a government-funded body that describes its purpose as being to improve science journalism. Its reporting on ME/CFS has been criticized for bias towards a psychological etiology for the disease.
Influence on treatment
The sheer size of the PACE trial means that it dominates the evidence base in ME/CFS. Together with other studies of CBT and GET, it is highly influential in UK clinical policy and that of many other countries, both in terms of healthcare provided by government and by private medical insurance.
In the UK, the NICE guidelines for NHS-provided care recommend CBT and GET for ME/CFS. They were published in 2007, before the PACE trial was conducted, but the evidence was based on a few small trials and was considered "somewhat limited". The ME Association has asked for the guidelines to be updated to take into account new treatment evidence, noting, "we assume that the guideline surveillance review that took place in March 2011, and which followed publication of the PACE trial in February 2011, simply ‘rubber stamped’ the 2007 NICE guideline recommendations on the basis that the PACE trial had supported the recommendations relating to CBT and GET." NICE responded, "we still do not feel that the evidence base is substantially evolving in this area at this time" and the guidelines currently remain on the "static" list.
In the US, the Mayo Clinic, Cleveland Clinic, Kaiser Permanente, and numerous key secondary medical education providers, such as UpToDate and WebMD, recommend CBT and GET, using PACE as a reference. CBT and GET are included in the Center for Disease Control's clinical guidelines for CFS, based on the PACE trial evidence.
Criticisms of the study
Selection of patients
The PACE trial used the Oxford criteria for diagnosis. Many patients and specialist clinicians consider them overly broad, and the National Institutes of Health 2015 P2P report on ME/CFS recommended that the Oxford definition be retired for this reason.
Changes in criteria for effectiveness and recovery
The authors abandoned their protocol-specified main outcome and recovery analyses partway through the trial and replaced them with others. They have defended the changes, noting, "All these changes were made before any outcome data were analyzed (i.e. they were pre-specified), and were all approved by the independent Trial Steering Committee and Data Monitoring and Ethics committee." However, 42 scientists, in an open letter to The Lancet, stated that the changes were of "of particular concern in an unblinded trial like PACE, in which outcome trends are often apparent long before outcome data are seen. The investigators provided no sensitivity analyses to assess the impact of the changes and have refused requests to provide the results per the methods outlined in their protocol."
Most notably, the authors introduced post-hoc "normal ranges" for fatigue and physical function. These ranges have been heavily criticised for having thresholds so low that patients could worsen from trial entry and yet be within these normal ranges. The "normal range" for physical function (measured on the SF-36 100-point scale) was 60 and above, even though patients had to score 65 or lower to enter the trial. A score of 60 is close to the mean physical function score (57) of patients with Class II coronary heart failure.
"The average age of participants in the PACE trial is about 39 years old; normative data suggest that people in this age group should have SF-36 scores of about 93. Yet the new 2013 “normal” is a score of 60."
The PACE authors used the "normal ranges", in conjunction with other thresholds, to define clinical effectiveness in the Lancet paper and recovery rates in a later paper in Psychological Medicine.
All Freedom of Information requests to the authors for the main outcome and recovery results according to the protocol-specified analyses, or for the underlying data so that others could conduct the analyses, have been refused.
Use of subjective main outcome measures
The study has been criticised for having subjective primary analyses in an unblinded trial. Subjective measures are known to be susceptible to bias, as can arise from expectations and social pressure. The CBT and GET groups, but not the others, were told that there was nothing to stop them from recovering if they gradually increased their activity, and critics have argued that these differential expectations could have inflated their self-assessments.
Conflicts of interest and lack of informed consent
The forty-two scientists and clinicians who wrote an open letter to the Lancet complaining about the PACE trial criticized the study authors' failure to disclose a potential conflict of interest to trial participants. They wrote:
"The investigators violated their promise in the PACE protocol to adhere to the Declaration of Helsinki, which mandates that prospective participants be 'adequately informed' about researchers’ “possible conflicts of interest.” The main investigators have had financial and consulting relationships with disability insurance companies, advising them that rehabilitative therapies like those tested in PACE could help ME/CFS claimants get off benefits and back to work. They disclosed these insurance industry links in The Lancet but did not inform trial participants, contrary to their protocol commitment. This serious ethical breach raises concerns about whether the consent obtained from the 641 trial participants is legitimate."
Newsletter to participants
The investigators published newsletters for participants while the trial was still underway. Critics have said that the material in the third newsletter could have influenced patients' self-reported outcomes. It included a number of positive testimonials from patients in the trial, but without naming their therapies. The PACE authors have argued that this meant that there would be no bias in favour of CBT and GET but Professor James Coyne has dismissed the idea that bias would be expected to affect all four groups equally.
The newsletter did, however, announce that the new NICE guidelines, "based on the best available evidence... recommended therapies [that] include Cognitive Behavioural Therapy, Graded Exercise Therapy and Activity Management." There was no explanation of what "Activity Management" was: no group had that title in the PACE trial. Dr. Bruce Levin, a professor of biostatistics at Columbia University and an expert in clinical trial design, said, “To let participants know that interventions have been selected by a government committee ‘based on the best available evidence’ strikes me as the height of clinical trial amateurism”. The newsletter also contained a less than positive assessment of research on the possibility of an infectious component of ME/CFS, including research by Jose Montoya on herpesviruses and by John Chia on enteroviruses. The newsletter said of Dr Chia's work, for example, "The laboratory work looked convincing, but many patients had significant gastro-intestinal symptoms and even signs, casting some doubt on the diagnoses of CFS being the correct or sole diagnosis in these patients." It is possible that this negative view of evidence of an ongoing infection would have made the rationale for APT appear less plausible and that for CBT and GET more plausible, thus biasing the participants.
An account of another study, in contrast, gave a positive assessment of CBT, saying "cognitive behaviour therapy was associated with an increase in grey matter of the brain and this increase was associated with improved cognitive function".
Risks and side effects
A survey conducted by the ME Association in 2012 showed that 74% of patients had their symptoms worsen after a course of GET. In contrast, the PACE trial found no apparently meaningful difference in rates of adverse events between the four trial groups, suggesting that APT, CBT and GET added no risk to SMC alone (since all four groups received SMC). However, critics have questioned whether patients actually increased their activity sufficiently in the CBT and GET groups to trigger many serious adverse events: the lack of improvement in the step-fitness test in all groups indicates that this is distinctly possible.
Response to criticism
The trial investigators have replied to criticism of the trial on a number of occasions, in response to letters to The Lancet concerning their main analyses, Psychological Medicine concerning their recovery analyses, and Lancet Psychiatry concerning their secondary mediation analyses  and long-term follow-up paper. A letter to the BMJ by Tom Kindlon drew a reply from the authors that in turn received 31 responses of its own.
The investigators have also responded to a 14,000-word critique by public health expert and journalist Dr David Tuller. Dr Tuller wrote a rebuttal to their response. He has said, “The PACE authors have long demonstrated great facility in evading questions they don’t want to answer”.
Professor James Coyne reported that he agreed to debate the authors on health website National Elf about the trial but that they declined. Professor Simon Wessely was given the vacated National Elf spot and wrote a lengthy article praising the trial, noting that he once described it as "a thing of beauty" and saying, "We can accept that PACE was a good trial and we can have some confidence in its findings".
The PACE Trial has been heavily criticised by patient groups and some researchers and science journalists for a number of methodological problems since its publication. 
Dr James Coyne, Professor of Health Psychology, at the University Medical Centre Gronigen (UMCG), published on PLoS One Blog on 29 October 2015 'Uninterpretable: Fatal flaws in PACE Chronic Fatigue Syndrome follow-up study' . He gave a talk at Edinburgh University in November 2015 heavily criticising the PACE trial . He spoke again about the PACE study in Belfast in February 2016 where he described it as "a wasteful trainwreck of a study". Professor Coyne has also questioned whether the PACE trial paper could ever have been properly peer-reviewed, given the large number of study authors and the small world of British science. He has continued to critique the PACE trial .
Dr Keith Laws, Professor of Neuropsychology, at the University of Hertfordshire has also criticised the PACE trial in a number of blogs on his website in November 2015 . He also co-authored a letter in the Lancet Psychiatry in 2016 with James Coyne Results of the PACE follow-up study are uninterpretable.
Science journalist, Julie Rehmeyer published an article in Slate Magazine in November 2015 called Hope for Chronic Fatigue Syndrome: The debate over this mysterious disease is suddenly shifting and contrasted the hope that sufferers had with research being conducted in the US and the UK researchers involved with PACE trial . Julie Rehmeyer has continued to criticise the PACE trial with further publications and in conferences.
A former editor of the Lancet analysed the PACE trial and provider her comments on the controversy and concluded "Psychiatrists need to understand that their presence anywhere near this condition is now toxic, and maybe they need to take a step back" .
Dr Mark Vink, a family physician in the Netherlands, published in the Journal of Neurology and Neurobiology on 30 March 2016 "The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review".
Prof Jonathan Edwards has declared that "PACE is valueless for one reason: the combination of lack of blinding of treatments and choice of subjective primary endpoint. Neither of these alone need be a fatal design flaw but the combination is". He also stated "the authors have not been meticulous in trying to avoid bias that might arise. On the contrary they appear to have acted in ways more or less guaranteed to maximise bias." .
In early 2016, Leonid Schneider, a science journalist, entered the debate and criticised the lack of data sharing by the PACE trial authors and the Lancet and its editor Richard Horton's role in the scandal and compared it to other recent Lancet scandals.   .
Prof Andrew Gelman, Professor of Statistics and Political Science at Columbia University, examined the Lancets role in how the PACE trial got taken so seriously and stayed afloat for so long  .
Sonia Lee, a clinical epidemiologist, published 30 slides critically appraising the PACE trial in February 2017 and gave a damning conclusion that the PACE trial authors should "rectify or retract".  
Professor Leonard Jason in the Journal of Health Psychology wrote in February 2017 The PACE trial missteps on pacing and patient selection which criticised the issue of patient selection in the trial with the use of the Oxford criteria included those without the disease and the PACE trial investigators did not design and implement a valid pacing intervention in the trial.
Prof Malcolm Hooper's complaints
Prof Malcolm Hooper and Margaret Williams have followed the PACE trial from its inception in 2004 and provided salutary warnings about the possible issues and problems with the conduct of the trial due to their previous knowledge of the principal investigators research .
They then published a 400 page critique of the PACE trial in February 2010 'Magical Medicine: How to make a disease disappear' . In February 2011 upon publication of the PACE trial findings, Prof Hooper submitted a comprehensive complaint to the editor of the Lancet and a further detailed response .
Prof Hooper et al in 2011 published further concerns about the PACE trial and have also examined the role of the Science Media Centre and the insurance industry with the PACE trial  . Prof Hooper has published a summary of the key dates and chronology of the trial since 2004 .
Major Investigation by Investigative journalist and academic in public health & journalism - Dr David Tuller
Renewed interest in the trial came in October 2015 with public health expert and investigative journalist Dr David Tuller's investigative Tour de Force "Trial by Error: The Troubling Case of the PACE Chronic Fatigue Syndrome Study" publication on Virology Blog which gave a detailed analysis of PACE's methodological problems. Dr Tuller continues to publish articles criticising different aspects of the trial. The main articles for the Trial by Error Series are listed below.
Trial by Error Series
- Oct 21 2015 "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study"
- Oct 22 2015 "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study (second instalment)"
- Oct 23 2015 "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study (final instalment)"
- Oct 30 2015 PACE trial investigators respond to David Tuller
- Oct 30 2015 "David Tuller responds to the PACE Investigators"
- Nov 4 2015 "Trial By Error, Continued: Did the PACE Study Really Adopt a ‘Strict Criterion’ for Recovery?"
- Nov 13 2015 "An open letter to Dr. Richard Horton and The Lancet"
- Nov 17 2015 "Trial by error, Continued: PACE Team’s Work for Insurance Companies Is “Not Related” to PACE. Really?"
- Dec 17 2015 A request for data from the PACE trial
- Dec 22 2015 Revisiting the PLoS One economics analysis of PACE
- Jan 4 2016 Trial By Error, Continued: Questions for Dr. White and his PACE Colleagues
- Jan 7 2016 Trial By Error, Continued: Did the PACE Trial Really Prove that Graded Exercise Is Safe? (with Julie Rehmeyer)
- Jan 19 2016 At least we’re not vexatious
- Jan 19 2016 Trial By Error, Continued: More Nonsense from The Lancet Psychiatry
- Feb 1 2016 Trial By Error, Continued: A Few Words About “Harassment”
- Feb 10 2016 An open letter to The Lancet, again
- May 23 2016 An open letter to PLoS One.
- July 10, 2016 - TWiV 397 podcast with Dr. Tuller and Dr Racaniello (1:03)
- Aug 29 2016 Once Again, Lancet Stumbles on PACE
- Sep 1, 2016 Trial By Error, Continued: My Questions for Lancet Editor Richard Horton
- Sept 6, 2016 Open letter to Queen Mary University of London about PACE
- Sept 22, 2016 Trial By Error, Continued: The Real Data
- Oct 27, 2016 Worse Than the Disease
- Mar 13, 2017 An open letter to Psychological Medicine about “recovery” and the PACE trial
- Mar 23, 2017 An open letter to Psychological Medicine, again!
The PACE trial authors with the exception of their response to Virology on October 30 2015 have refused to respond to or engage with David Tuller about any of these concerns. They refused to respond and ignored a number of requests for comments by David Tuller in 2015 and 2016. Similarly Richard Horton, editor of the Lancet has refused to respond to Tuller about these concerns or about retraction of the PACE trial publication. Sir Simon Wessely on behalf of the PACE trial principal investigators did publish an article in November 2015 The PACE trial for chronic fatigue syndrome: choppy seas but a prosperous voyage referring to the growing concerns over the PACE trial. This was published in a blog website called National Elf Service run by the Mental Elf in which he used an analogy of the clinical trial as an ocean liner crossing the Atlantic.
Scientists' open letter to The Lancet
In November 2015, scientists Ronald Davis, David Tuller, Vincent Racaniello, Jonathan Edwards, Leonard Jason, Bruce Levin and Arthur Reingold wrote an open letter to The Lancet citing "major flaws" in the original trial publication and asking for an independent re-analysis of the individual-level trial data. The journal failed to respond.
In February 2016 the open letter was re-published with 36 additional signatures from doctors and researchers including: Dharam Ablashi, Lisa Barcellos, James Baraniuk, Lucinda Bateman, David Bell, Alison Bested, Gordon Broderick, John Chia, Lily Chu, Derek Enlander, Mary Ann Fletcher, Kenneth Friedman, David Kaufman, Nancy Klimas, Charles Lapp, Susan Levine, Alan Light, Sonya Marshall-Gradisnik, Peter Medveczky, Zaher Nahle, James Oleske, Richard Podell, Charles Shepherd, Christopher Snell, Nigel Speight, Donald Staines, Philip Stark, John Swartzberg, Ronald Tompkins, Rosemary Underhill, Rosamund Vallings, Michael VanElzakker, William Weir, Marcie Zinn and Mark Zinn.
On 13 March 2017 David Tuller and the original signatories to the open letter to the Lancet in 2016 and an additional 37 signatories signed an open letter to the Journal of Psychological Medicine. In total 102 signatories signed this open letter regarding the recovery paper of 2013 to the Journal of Psychological Medicine.
These included scientists and medical professionals including Molly Brown, Todd E. Davenport, Simon Duffy, Meredyth Evans, Robert F. Garry, Keith Geraghty, Ian Gibson, Rebecca Goldin, Ellen Goudsmit, Maureen Hanson, Malcolm Hooper, Betsy Keller, Andreas M. Kogelnik, Eliana M. Lacerda, Vincent C. Lombardi, Alex Lubet, Steven Lubet, Patrick E. McKnight, Jose G. Montoya, Henrik Nielsen, Elisa Oltra, Nicole Porter, Anders Rosén, Peter C. Rowe, William Satariano, Ola Didrik Saugstad, Eleanor Stein, Staci Stevens, Julian Stewart, Leonie Sugarman, Mark VanNess, Mark Vink, Frans Visser, Tony Ward, John Whiting, Carolyn Wilshire and Michael Zeineh.
27 ME Charities from 17 countries also co-signed the open letter including 25% ME Group (UK), Emerge Australia, European ME Alliance: Belgium ME/CFS Association, ME Foreningen (Denmark), Suomen CFS-Yhdistys (Finland), Fatigatio e.V.,(Germany), Het Alternatief (Netherlands), Icelandic ME Association, Irish ME Trust, Associazione Malati di CFS (Italy), Norges ME-forening (Norway), Liga SFC (Spain), Riksföreningen för ME-patienter, (Sweden), Verein ME/CFS Schweiz (Switzerland), Invest in ME Research (UK), Hope 4 ME & Fibro Northern Ireland, Irish ME/CFS Association, Massachusetts CFIDS/ME & FM Association (USA), ME Association (UK), ME/cvs Vereniging (Netherlands), National ME/FM Action Network (Canada), New Jersey ME/CFS Association (USA),Pandora Org (USA), Phoenix Rising, International Solve ME/CFS Initiative (USA), Tymes Trust (UK) and Wisconsin ME and CFS Association (USA).
On 23 March 2017 David Tuller reported that one of the editors of the Journal of Psychological, Sir Robin Murray, responded with a "unacceptable response." Tuller restated that "That the editors of Psychological Medicine do not grasp that it is impossible to be “disabled” and “recovered” simultaneously on an outcome measure is astonishing and deeply troubling." The open letter was reposted with 17 additional individuals and 23 more charities.
Petitions and Protests
On October 28, 2015, MEAction launched a petition addressed to The Lancet, Psychological Medicine and the PACE trial authors, calling for an independent analysis of the data and the retraction of some of the PACE trial's "misleading claims" based on "absurd 'normal ranges' for fatigue and physical function". The petition was closed in February 2016, having gathered 11,897 signatures from people in sixty-four countries.
A US petition to the Agency for Healthcare Research and Quality (AHRQ) and the Centers for Disease Control was also launched in late 2015, asking government agencies to remove guidelines and recommendations based on PACE and other studies using the Oxford definition of ME/CFS.
During International ME Awareness day (12 May) in 2017 due to the intransigence of the PACE researchers for years, a Millions Missing protest in London resulted in hundreds of patients protesting against the PACE trial   
Allegations of harassment
The PACE trial investigators and Professor Simon Wessely have publicly claimed they have been harassed and subjected to death threats. A feature article in the BMJ (read by most UK doctors) was published in June 2011 called Dangers of research into chronic fatigue syndrome . The Times article was titled 'Doctor’s hate mail is sent by the people he tried to cure' . An article was also published in the Sunday Times magazine with Simon Wessely repeating the death threats narrative  .
However, the PACE authors and their supporters have been accused of blurring the line between harassment and legitimate criticism of the study. Documentation obtained under the Freedom of Information Act from meetings in 2013 that were attended by some of PACE’s principal investigators include a statement that “harassment is most damaging in the form of vexatious FOIs [Freedom of Information requests].” This framing of FOIA requests as harassment is widely taken to be a reference to the PACE authors, who have complained about the number of FOI requests that they have received for data and who have dismissed several as "vexatious": the Information Commissioner's Office was told that Professor Peter White “believes that the requests are clearly part of a campaign to discredit the trial” and that “the effect of these requests has been that the team involved in the PACE trial, and in particular the professor involved, now feel harassed and believe that the requests are vexatious in nature.”
The criticisms of the trial's methodology and analyses by patients and others has been referred to by the investigators - and The Lancet - as part of a campaign to undermine the the study. In an editorial comment that accompanied letters criticising the trial, The Lancet described the trial as “rigorously conducted” and questioned whether the “coordination of the response... has been born... from an active campaign to discredit the research”. In an interview on Australian national radio shortly after publication, Dr Richard Horton, The Lancet’s editor, described patients who criticised the trial as “a fairly small, but highly organised, very vocal and very damaging group of individuals”.
The PACE trial authors refused to provide anonymised data to many individuals and also refused to accept the Information Commissioners Office decision for QMUL to release the data in 2015 (see Release of Data/Information Tribunal below). During the PACE trial authors appeal to the Tribunal an article was published during this period by their associates in Nature in which they bizarrely in projection described disabled ME sufferers as “hard-line opponents” of research into chronic fatigue syndrome and compared them with industry lobbyists such as tobacco and climate change denialists. .  . Public health expert and journalist David Tuller, who has said, “Wrapping themselves in victimhood, the [PACE authors] have even managed to extend their definition of harassment to include any questioning of their science and the filing of requests for data — a tactic that has shielded their work from legitimate and much-needed scrutiny.”  
An article in the Establishment in May 2016, The Hidden Battle For The Rights Of Chronic Fatigue Syndrome Sufferers summarised the campaign to smear ME sufferers and how these psychiatrists after categorising ME as a psychological over two decades then were able to use institutional gaslighting when patients were question the scientific validity of the trial and to stop access to data requests from the PACE trial by framing them as harassment and abuse.
No evidence of anyone with ME/CFS being charged by the police with harassment and death threats has come to light.
Breaches of patient's data security by study investigators
In 2006 confidential PACE trial patient data was stolen from an unlocked drawer at King's College London.
Other major investigations and reports
The Centre for Welfare Reform published a 64 page report in April 2016 examining the PACE trial and relating the study to the biopsychosocial model and its links and influence from the insurance industry and government welfare reforms. The report titled 'In the Expectation of Recovery' by George Faulkner heavily criticised the PACE trial and stated “The way in which the biopsychosocial model has been used and promoted, without good supporting evidence for many of the claims being made, is unethical.” and “Had homeopaths or a pharmaceutical company conducted a trial and presented results in the manner of the PACE trial the British research community would have been unlikely to overlook its problems.” Dr Simon Duffy writing in the Huffington Post questioned the motive of the research in The Misleading Research at the Heart of Disability Cuts.
Sense about Science USA (SAS USA) published a major statistical examination of the PACE trial in March 2016. The Executive Director of SAS USA, Trevor Butterworth wrote an accompanying editorial on PACE. Prof Rebecca Goldin of Mathematical Sciences at George Mason University and Director of STATS (a collaboration between SAS USA and the American Statistical Association) wrote the 7000 word statistical critique PACE: The research that sparked a patient rebellion and challenged medicine. 
In August 2016 Julie Rehmeyer presented a critique of the PACE trial at the largest gathering of statisticians in North America, the Joint Statistical Meeting 2016, in Chicago titled Bad Statistics, Bad Reporting, Bad Impact on Patients: The Story of the PACE Trial. Rehmeyer said “When I went through the slides showing the changes to the physical function criterion for recovery, I saw jaws drop.” 
PACE Trial in Parliament
The PACE Trial has been the subject of a number of parliamentary enquiries by parliamentarians mainly the Countess of Mar. The Countess of Mar asked questions of the government via a short debate in the House of Lords on the assessment of the PACE trial on 6 February 2013.   During the court case below in 2015 by Matthees and the Information Commissioners Office v QMUL it was stated by Peter White that he regarded parliamentary debates as harassment and had to brief those taking part in the debate. In November 2016 Kelvin Hopkins MP asked seven written questions relating to the PACE Trial including "request that the Medical Research Council conducts an inquiry into the management of the PACE trial to ascertain whether any fraudulent activity has occurred." and "prevent the PACE trial researchers from being given further public research funding until an inquiry into possible fraudulent activity into the PACE trial has been conducted."
Calls to release data
Open data commitments
The 2012 PACE cost-effectiveness paper was published in the journal PLoS One. That journal requires authors, as a condition of submitting their papers, to agree to release the anonymized trial data underlying the paper's analyses upon request. In November 2015 Professor James Coyne made a request to the PACE authors on that basis, but the authors treated his request as a Freedom of Information request and refused it. However in March 2016 the PLoS One journal confirmed they had requested the investigators to release the trial data, as they committed to do prior to publication.
In 2015 Peter White lobbied the UK government to restrict the Freedom of Information Act 2000 for universities especially for controversial research and cited the PACE trial and compared ME patients requesting data with "climate change science, and research into the health effects of tobacco" 
Freedom of Information requests
The PACE trial investigators have been asked for 160 pieces of separate information in 35 Freedom of Information requests since 2011. They have dismissed at least three of these claims as "vexatious". 
A ruling by a UK government body, the Information Commissioner's Office (ICO), on 27 October 2015 ordered Queen Mary University of London (QMUL, the institutional base of the PACE trial's lead investigator Peter White) to release the trial data to a patient who had requested it, subject to appeal within 28 days. Three Freedom of Information requests from 2012 and 2013 were included in the ICO's decision. An appeal by QMUL was heard by the First-Tier Tribunal on 20-22 April 2016. QMUL responded to a freedom of information request confirming the cost of its legal fees for the tribunal totalled £245,745.27 (around USD350,000). The First-Tier Tribunal judgement was published on 16 August 2016, roundly dismissing the appeal by QMUL, and deciding that the PACE trial data should be released. The university has not yet stated whether it will appeal the judgement.
The PACE patient consent form was released through a Freedom of Information request.
Dr Richard Horton, editor of The Lancet, stated on 18 April 2011 in a national Australian radio interview: "The Freedom of Information requests and the legal fees that have been racked up over the years because of these vexatious claims has added another £750,000 of taxpayers’ money to the conduct of this study".
Data requests from scientists
Professor James Coyne has publicly called for the trial data to be released. He has repeatedly criticized the PACE investigators for failing to abide by modern expectations concerning "open data".
Professor Coyne's own request for the data was dismissed under the Freedom of Information Act by the study authors as "vexatious" and as having an "improper motive".
Scientists Ronald Davis, David Tuller, Bruce Levin, and Vincent Racaniello requested the PACE trial data in December 2015. Their request was rejected by the trial investigators.. On International ME Awareness day in May 2016 in an interview with an advocate's article called PACE-Gate, Dr Racaniello stated "“I think they are going to ignore, obfuscate, and give their usual responses until we are all dead. I don’t have hope that the PACE authors, or Lancet, will respond in any meaningful way until there is more of an outcry.” .
ME Charities and others calls for data release
A number of patient charity groups and individuals have called for the release of the PACE data, including some outside the ME/CFS community who advocate "open data" in science. These calls include:
- 2016: open letters from two patient charities, in Australia, ME/CFS Australia (SA) Inc and Emerge Australia, calling for the data to be released.
- 2016: an open letter the European ME Alliance (EMEA) representing patient group charities from 12 European countries (Belgium, Denmark, Finland, Germany, Holland, Iceland, Ireland, Norway, Spain, Sweden, Switzerland and UK), calling for the data to be released.
- 2016: an open letter by Mark Berry of Phoenix Rising, a US based non profit with the largest ME patient forum membership in the world, calling for the data to be released.
- 2016: open letters from British patient charities Action for ME, Invest in ME, ME Association, Tymes Trust, ME Research UK, Hope 4 ME & Fibro NI, the Welsh Association of ME & CFS Support and the 25 Percent ME Group.
- 2016: an open letter from the Irish ME Trust charity 
- 2016: an open letter from a Canadian patient group, the National ME/FM Action Network.
- 2016: open letter from two Belgian patient organisations, ME-Gids.net and WUCB 
- 2016: an open letter from Dutch patient group, Groep ME-DenHaag/ The Dutch Citizen’s Initiative for ME patients  and a joint letter from three further dutch patient group charities, ME/CVS Vereniging, ME/CVS Stichting Nederland, Steungroep ME en Arbeidsongeschiktheid
- 2016: an article, "PACE trial and other clinical data sharing: patient privacy concerns and parasite paranoia", by Leonid Schneider, an independent science journalist.
- 2015: a blog post by Dr Richard Smith, former editor of The BMJ, who said that the PACE authors' institutions were "making a mistake... the inevitable conclusion is that they have something to hide.” and in article for F1000 Research 
- 2016, Release the PACE trial data: My submission to the UK Tribunal, James Coyne, 18 Aug 2016.
A ME charity polled on the question "Should or should not the anonymised data from the PACE trial be released for independent analysis?" As at 17 March 2016, 1391 voters took part and 99% (1378 voters) voted for 'Should be released'. 0% (5 voters) voted for 'Should not be released' .
Both cofounders of Retraction Watch, Ivan Oransky and Adam Marcus, added their weight behind patients in the refusal of the PACE trial investigators to release the anonymised data in article in STAT News feature 'The Watchdogs Keeping an eye on misconduct, fraud, and scientific integrity' To keep science honest, study data must be shared and concluded "when researchers refuse to share data, and how they came up with it, they lose the right to call what they do science".
This battle was reported in the Wall Street Journal by Amy Dockser Marcus on 7 March 2016 as Patients, Scientists Fight Over Research-Data Access, which featured quotes from David Tuller, Tom Kindlon, Anna Sheridan Wood, James Coyne,. .
Release of Data
Alem Matthees , an Australian ME sufferer, submitted a FOIA request to the PACE trial authors who were ordered to provide the requested data by the Information Commissioners Office. This decision was appealed by them to the Information Tribunal and was heard on April 20th 2016 at a three day hearing.
Mr Alem Matthees original Freedom of Information Act 2000 request to QMUL Selected data on PACE Trial participants was submitted on 24 March 2014. QMUL refused to release the requested data and Mathees complained to the Information Commissioners Office. The Information Commissioners decision was made on 27 October 2015 and concluded that QMUL should release the data.
The Information Commissioners response to the Tribunal as First Respondent of 12 January 2016 and Mr Alem Mathees Main response to Tribunal as Second Respondent was also submitted to the Tribunal for the three day hearing on 20, 21 and 22nd April 2016.
The Information Rights Tribunal Judgement was finally published on 16 August 2016.  The Tribunal upheld the original ICO decision and rejected the appeal by the PACE investigators and ordered QMUL to release the anonymised data to Mr Matthees.
The tribunal took evidence under the normal rules of court. The tribunal also concluded of the expert witness for the PACE authors that "It was clear that his assessment of activist behaviour was, in our view, grossly exaggerated and the only actual evidence was that an individual at a seminar had heckled Professor Chalder” and "clearly in our view had some self-interest, exaggerated his evidence and did not seem to us to be entirely impartial. What we got from him was a considerable amount of supposition and speculation, with no actual evidence to support his assertions or counter the respondents arguments." The tribunal panel noted that the Commissioner had referred to Professor Anderson’s “wild speculations” that “young men, borderline sociopathic or psychopathic” would attempt to identify trial participants from the anonymised data, and said that his views “do him no credit”. 
The decision noted in the evidence that "Contrast instead Professor Chalder when she accepts that unpleasant things have been said to and about PACE researchers only, but that no threats have been made either to researchers or participants. The highest she could put it was some participants stated that they had been made to feel "uncomfortable" as a result of their contact with and treatment from her, not because of their participation in the trial per se. There is no evidence either of a campaign to identify participants nor even of a risk of an 'insider threat'.”
Moreover, regarding the independent Cochrane review it was admitted in the tribunal that "Professor Chalder states that disclosure to the Cochrane review does not count as disclosure to independent scientists as all three of the PACE principal investigators sat on the review panel."
Additionally, a UK ME sufferer submitted a FOI request in June 2016 and established that the PACE trial investigator's university paid £245,745.27 for legal fees to defend their case in the tribunal against the original ICO decision.  
The lead PACE investigator's university issued a statement the same day stating "We are studying the decision carefully and considering our response" . An open letter in support of Alem Matthees was sent to the university and signed by Dr Ronald Davis, Dr Jonathan Edwards, Dr Rebecca Goldin, Dr Bruce Levin, Dr Zaher Nahle, Dr Vincent Racaniello, Dr Charles Shepherd and Dr John Swartzberg strongly urging them to not appeal further.
Results of Reanalysis
Virology blog published the re-analysis on 21 September No ‘Recovery’ in PACE Trial, New Analysis Finds and concluded " The results should put to rest once and for all any question about whether the PACE trial’s enormous mid-trial changes in assessment methods allowed the investigators to report better results than they otherwise would have had. While the answer was obvious from Dr. Tuller’s reporting, the new analysis makes the argument incontrovertible."
The full re-analysis was published as 'A preliminary analysis of ‘recovery’ from chronic fatigue syndrome in the PACE trial using individual participant data' and was conducted by Alem Matthees, Tom Kindlon, Carly Maryhew, Philip Stark and Bruce Levin and stated "This re-analysis demonstrates that the previously reported recovery rates were inflated by an average of four-fold.".
'A critical commentary and preliminary re-analysis of the PACE trial' was published in December 2016 in the Journal of 'Fatigue: Biomedicine, Health & Behavior' by Dr Carolyn Wilshire, Tom Kindlon, Alem Matthees and Simon McGrath which found that "The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments" .
'A Rejoinder to Sharpe, Chalder, Johnson, Goldsmith and White' was published by Dr Carolyn Wilshire, Tom Kindlon and Simon McGrath in response to the PACE authors reply to their original publication . Wilshire et al disproved again the PACE trials misleading claims as recovery was a strong claim and did not adhere to the core meaning of the word, no evidence that the original protocol specified definition was too stringent and absolute recovery rates from other studies were not legitimate source of support for the recovery definition used. It reinforced the original conclusion that "The PACE trial provides no evidence that CBT and GET can lead to recovery from CFS. The recovery claims made in the PACE trial are therefore misleading for patients and clinicians".
Instead of engaging with critics by releasing other additional requests for data, the PACE trial authors updated their guidelines in January 2017 for those requesting access to the PACE trial data which further restricted access by requiring "formal agreement" with "precise analytic plans, and plans for outputs" . Prof James Coyne commented that it is "a ruse to trap the unwary in endless haggling and appeal, while protecting the PACE investigators from the independent reanalysis of the claims, which they have already declared poses a reputational risk to them". 
Despite patients and critics not having access to the Science Media Centre the media coverage especially outside the UK was extensive.
- 17 August 2016 - Retraction Watch Tracking retractions as a window into the scientific process UK tribunal orders release of data from controversial chronic fatigue syndrome study .
- 18 August 2016 - - Dagens Medicine, Sweden Döms lämna ut råmaterial till Pace-studien
- 22 August 2016 - BMJ Tribunal orders university to release data from PACE chronic fatigue study 
- 19 August 2016 -iNews UK Chronic Fatigue Syndrome sufferers have just had a small victory, iNews UK, 
- 19 August 2016 - iNews UK Chronic Fatigue Syndrome: tribunal orders data from controversial trial to be released, iNews UK, 
- 19 August 2016 - Applied Clinical Trials - Tribunal Orders Release of Withheld Data from London Trial
- 22 August 2016 - WDDTY Researchers who claimed chronic fatigue is “all in the mind” forced to disclose data
- 27 August 2016 - The Conversation Tribunal was right to order release of chronic fatigue trial data, Jonathan Edwards, 27 Aug 2016.
- 30 August 2016 - SBS.Com Australia Do you suffer from Chronic Fatigue Syndrome? There's some good news for you
- 6 September 2016 - Huffington Post Studie zum Erschöpfungssyndrom: Wenn die Wissenschaft versagt/ Study on fatigue syndrome: When science fails
- 12 September 2016 -WDDTY Chronic fatigue sufferers getting the wrong treatment—thanks to a falsified study
- 21 September 2016 - STAT News by Julie Rehmeyer Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back
- 21 September 2016 - Business Insider UK How millions of patients with a crippling, misunderstood disease were misled by bad science/
- 21 September 2016 - New York Mag, Science of US The Implosion of a Breakthrough Study on Chronic Fatigue Syndrome title/
- 22 September 2016 -Patient POV Moving the Goal Posts to Catch the Ball and Other Hazards of A Chronic Fatigue Syndrome Treatment Trial/
- 22 September 2016 - MedPage Today PACE Takedown
- 23 September 2016 - Dagens Medicine, Sweden Pace-studie kritiserad på nytt efter släppt rådata/ Pace study criticized again after released the raw data
- 23 September 2016 - Science Alert Bad science has misled millions with chronic fatigue, court order reveals
- 24 September 2016- Retraction Watch controversial PACE study re-analyzed
- 26 September 2016 - Health Insights UK Independent investigation reveals NICE approved treatment only a fraction as effective as experts claim it is.
- 28 September 2016 - The Times Exercise and therapy cure for ME is ‘seriously flawed’
- 29 September 2016 - BMJ Reanalysis of PACE trial reignites row over chronic fatigue treatment
- 2 October 2016 - The Canary The results they really didn’t want you to see: key ME/CFS trial data released
- 6 October 2016 - Newswork Radio WHYY-FM Podcast with Julie Rehmeyer Was advice for people with Chronic Fatigue Syndrome all wrong?
- 6 October 2016 - The Limbic PACE trial labeled a sham
- 7 October 2016 - 6 Minutes, Australia Analysis rekindles chronic fatigue controversy
- 9 October 2016 - Aftenposten, Norway Forskningsjuks eller rabiate pasienter?
- 17 October 2016 - The Telegraph Doctor's Diary: Gove was right, we have had enough of experts
- 20 October 2016 - Hippocratic Post ME: The truth about exercise and CBT
- 19 October 2016 - Deutschland Funk Radio (Germany) Patienten fechten Studienergebnisse an/ Patients are challenging study results
- 27 October 2016- Undark For Chronic Fatigue Syndrome, a Dubious Therapy / Worse Than the Disease by Dr David Tuller
- 31 October 2016 - Undark Undark Podcast #8: Worse Than the Disease with NYT Science Times editor David Corcoran & David Tuller
- 2 November 2016 - The Times I got ME and thought: ‘This is the end
- 17 August 2016 QMUL "studying" PACE data-release ruling, #MEAction, 17 Aug 2016.
- 7 December 2016- Private Eye Trial on Trial and correspondence  
- 19 December 2016 - Undark A Study of Chronic Fatigue Syndrome Therapies Is Debunked (Again)
- 1 January 2017 - Suomen Kuvalehti Miljoonia maksanut jättitutkimus paljastui roskaksi: Yhä sairaammat potilaat julistettiin parantuneiksi
- 17 January 2017 - News.com Australia How Alem Matthees’ letter helped solve Chronic Fatigue Syndrome mystery
- 8 February 2017 - New Scientist We need transparent trials to keep confidence in medicine and response by PACE author. .
- 20 February 2017 - Carte Blanche South Africa (Investigative Journalism TV) - CFS: Millions Missing
- 8 March 2017 - Observant, Netherlands (Mythbusters) Myth: ME is a mental illness and response by PACE authors 
- 18 March 2017 - The New York Times (Sunday Review) by Julie Rehmeyer & David Tuller Getting It Wrong on Chronic Fatigue Syndrome
- 21 March 2017 - The Guardian Yet more research shows chronic fatigue syndrome is real. When will health services catch up?
- 22 March 2017 - Observant, Netherlands, Gedrags- en bewegingstherapie zijn schadelijk / "Behavioral and movement therapy are harmful"
- 23 March 2017 - The Conversation (Academic Rigour, journalistic flair) How a study about Chronic Fatigue Syndrome was doctored, adding to pain and stigma by Prof Steven Lubet and on MedicalXpress  and Associated Press (AP) The Big Story 
- 27 March 2017 - Observant, Netherlands, (Mythbusters) PACE trial misrepresents their own results again by Dr Mark Vink
- 29 March 2017 - Observant, Netherlands, Stunned by the absence of critical thinking” by Dr Carolyn Wilshire
- 26 March 2017 - Jerusalem Post, Israel Wrong of Chronic Fatigue Syndrome
- 27 March 2017 - Observant, Netherlands, No scientific ground to stand on by Dr David Tuller
- 4 April 2017- Science Based Medicine, Treating Chronic Fatigue Syndrome with Cognitive Behavioral Therapy and Graded Exercise Therapy: How the PACE Trial Got It Wrong by Dr Harriet Hall
Queen Mary University of London/Student Union - The Print Newspaper
- 19th January 2016 - Scientists Demand Transparency on PACE Trial
- 3 October 2016 - Judge Dismisses QMUL’s Appeal, University Must Release PACE Data
- 14 November 2016 - PACE Trial Data Released
- 5 October 2016 - International Journal of Care Coordination - editorial 'Can scientific evidence be valid if irrelevant to patients?'
- 1 November 2016 - Dr Keith Geraghty pubished in The Journal Of Health Psychology ‘PACE-Gate’: When clinical trial evidence meets open data access and some of the PACE authors had a Response to the editorial in January 2017.
- 10 January 2017 - Dr Mark Vink published in Journal of Neurology and Neurobiology 'Assessment of Individual PACE Trial Data: in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Cognitive Behavioral and Graded Exercise Therapy are Ineffective, Do Not Lead to Actual Recovery and Negative Outcomes may be Higher than Reported'
- 7 March 2017 - Prof Steven Lubet, Law Professor at NorthWestern University published in the Journal of Health Psychology 'Investigator bias and the PACE trial'
- 20 March 2017 - Tom Kindlon 'Do graded activity therapies cause harm in chronic fatigue syndrome?'
- 24 March 2017- Dr Carolyn Wilshire in the Journal of Health Psychology 'The problem of bias in behavioural intervention studies: Lessons from the PACE trial'
- 24 March 2017- Prof Jonathan Edwards 'PACE team response shows a disregard for the principles of science'
- 9 April 2017 Dr Charles Shepherd ‘It’s time for an independent review of the PACE Trial methods and results’
- 27 April 2017 - Dr Mark Vink 'PACE trial authors continue to ignore their own null effect'
- 27 April 2017 - Dr David Tuller 'Once again, the PACE authors respond to concerns with empty answers'
- 12 May 2017 - Karen Kirke 'PACE investigators’ response is misleading regarding patient survey results'
- 12 May 2017 - Bart Stouten 'PACE-GATE: An alternative view on a study with a poor trial protocol\
- 18 May 2017 - Prof Keith Laws "Distress signals: Does cognitive behavioural therapy reduce or increase distress in chronic fatigue syndrome/myalgic encephalomyelitis?"
- Solve CFS - Preliminary analysis of newly released PACE trial data confirms initial publication results were unsound
- OccupyME - PACE: Grossly Exaggerated
- The Faculty Lounge by Steven Lubet - The PACE Study Results Exposed as Meaningless and Harmful
- Academic Health Economist - Data sharing and the cost of error
- BMJ - Simon McGrath: PACE trial shows why medicine needs patients to scrutinise studies about their health
- Intelligent Medicine - Part 1: A Flawed Study on Chronic Fatigue Syndrome; Patients Fight Back
- Hannah Radenkova - The PACE trial Fiasco
Media Response by PACE authors
- 30 September 2016 - Guardian If my team’s research on ME is rejected, the patients will suffer by Peter White
- 21 September 2016 Freedom of information: can researchers still promise control of participants’ data? Note: This article was written by Nigel Hawkes of the BMJ who wrote the earlier article in the BMJ 'Dangers of Research into chronic fatigue syndrome' in 2011. The narrative of threatening activists was dismissed by the Tribunal . Alem Matthees submitted a rapid response to the BMJ but this was not published and he then published it on pubmed.
- 2016, Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back, Julie Rehmeyer, Stat News, 21 Sep 2016.
Responses by Scientific Journals and Medical Guidelines
Agency for Healthcare Research and Quality amendment
The US government agency called the Agency for Healthcare Research and Quality (AHRQ) revised its earlier recommendations about found that when studies of CBT and GET, including PACE, that used the Oxford Criteria were excluded, there was no evidence for graded exercise and only weak evidence for CBT. Mary Dimmock led the way on this issue with AHRQ and co-authored with Jennie Spotila AHRQ Evidence Review Changes Its Conclusions.
PLOS Expression of Concern
Prof James Coyne had requested anonymised data in 2015 from the PACE trial authors from the Cost Effectiveness paper. He pursued this request throughout 2015 and 2016 but was also refused as "vexatious". After 18 months, PLOS issued an Expression of Concern on May 2nd 2017. It stated "We conclude that the lack of resolution towards release of the dataset is not in line with the journal’s editorial policy and we are thus issuing this Expression of Concern to alert readers about the concerns raised about this article . The Editors of PLOS One, Iratxe Puebla and Joerg Heber, wrote in PLOS One Blog "Since we feel we have exhausted the options to make the data available responsibly, and considering the questions that were raised about the validity of the article’s conclusions, we have decided to post an Expression of Concern to alert readers that the data are not available in line with the journal’s editorial policy" . Retraction Watch reported on the development 
Quotes from PACE trial critics
"This is a flawed study, it has to be fixed and people are being harmed by it."
"... multiple flaws that are inexcusable."
"In short, the PACE study is a sham, with meaningless results. In this case, the emperor truly has no clothes. Dr. Horton and his editorial team at The Lancet are stark naked."
Trevor Butterworth is the Editor of 'Sense About Statistics,' an online collaboration between the American Statistical Association and Sense About Science USA.
"...the way PACE was designed and redesigned means it cannot provide reliable answers to the questions it asked. There is really not a lot that can be said to mitigate that; it’s a terminal prognosis."
Professor Coyne is Professor of Health Psychology, University Medical Center, Groningen and University of the Netherlands; Distinguished Visiting Professor at the Institute for Health Policy, Rutgers, the State University of New Jersey; and Professor Emeritus of Psychology in the Department of Psychiatry, University of Pennsylvania. He is one of the most cited psychologists in the academic literature.
"The data presented are uninterpretable. We can temporarily suspend critical thinking and some basic rules for conducting randomized trials (RCTs), follow-up studies, and analyzing the subsequent data. Even if we do, we should reject some of the interpretations offered by the PACE investigators as unfairly spun to fit what [is] already a distorted positive interpretation of the results."
"The self-report measures do not necessarily capture subjective experience, only forced choice responses to a limited set of statements."
"One of the two outcome measures, the physical health scale of the SF-36 requires forced choice responses to a limited set of statements selected for general utility across all mental and physical conditions."
"The validity [of the] other primary outcome measure, the Chalder Fatigue Scale depends heavily on research conducted by this investigator group and has inadequate validation of its sensitivity to change in objective measures of functioning."
Professor Coyne gave a public talk criticising the PACE trial in Edinburgh in November 2015. Video footage is available, as are a slide show, a full and an edited transcript and an audio recording.
Professor Coyne has questioned whether the PACE trial paper could ever have been properly peer-reviewed, given the large number of study authors and the small world of British science.
Professors James Coyne and Keith Laws
Professor Coyne and Professor Laws of the University of Hertfordshire have criticised, in a joint letter to Lancet Psychiatry, the long-term follow-up analysis of the PACE trial that was published in 2015. Referring to the results of the study as a whole, they said:
"There are no group differences, and the overall mean short-form 36 (SF-63) physical functioning score is less than 60. It is useful to put this number in context. 77% of the PACE trial participants were women, and the mean age of the trial population was 38 years, with no other disabling medical conditions. Patients with lupus have a mean physical functioning score of 63, patients with class II congestive heart failure have a mean score lower than 60, and normal controls with no long-term health problems have a mean score of 93."
Professor Ronald Davis is a world-famous geneticist at Stanford University, known for work that enabled the Human Genome Project.
“I’m shocked that the Lancet published it... The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”
Professor Edwards, of University College London, is internationally known for his pioneering work in establishing B-cell depletion therapy as an effective treatment for rheumatoid arthritis.
“It’s a mass of un-interpretability to me…All the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible....Within the circle who are involved in this field, it seems there were a group who were prepared to all sing by the hymn sheet and agree that PACE was wonderful. But all the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible.”
Professor Rebecca Goldin
Professor Goldin is Professor of Mathematical Sciences at George Mason University and Director of STATS.org (USA).
"The PACE design changed so significantly as to leave many wondering whether there is value in the study itself."
"It seems that the best we can glean from PACE is that study design is essential to good science, and the flaws in this design were enough to doom its results from the start."
Dr Goudsmit is a retired health psychologist who has published a number of criticisms of the PACE trial.
"The PACE trial was scientifically extremely poor"
"A treatment like GET is simply not appropriate for a disease like ME which is linked to infection and metabolic abnormalities. Given the close relationship between exertion and symptoms, it follows that asking a patient to increase their activity levels is as logical as advising smokers with lung cancer to gradually increase the number of cigarettes they smoke"
Leonard Jason is a professor of psychology at DePaul University in Chicago, Illinois, and director of its Center for Community Research.
“The PACE authors should have reduced the kind of blatant methodological lapses that can impugn the credibility of the research, such as having overlapping recovery and entry/disability criteria.”
"My key points are that the PACE trial investigators were not successful in designing and implementing a valid pacing intervention and patient selection ambiguity further compromised the study’s outcomes."
Professor Levin is a professor of biostatistics at Columbia University and an expert in clinical trial design.
“To let participants know that interventions have been selected by a government committee ‘based on the best available evidence’ strikes me as the height of clinical trial amateurism.”
Professor Reingold is Head of Epidemiology at the University of California, Berkeley.
“Under the circumstances, an independent review of the trial conducted by experts not involved in the design or conduct of the study would seem to be very much in order.”
Dr Shepherd, medical advisor to the ME Association, has criticised the trial's long-term follow-up analyses:
"Without robust objective evidence relating to improvement and recovery, the ME patient community will continue to regard the PACE trial as a tremendous waste of research funding money".
Dr David Tuller
Dr Tuller is is academic coordinator of the University of California, Berkeley's joint masters program in public health and journalism. He was a reporter and editor for 10 years at the San Francisco Chronicle, served as health editor at Salon.com and frequently writes about health for The New York Times. He has written extensively about the PACE trial.
"The study included a bizarre paradox: participants’ baseline scores for the two primary outcomes of physical function and fatigue could qualify them simultaneously as disabled enough to get into the trial but already 'recovered' on those indicators–even before any treatment. In fact, 13 percent of the study sample was already 'recovered' on one of these two measures at the start of the study."
"In the middle of the study, the PACE team published a newsletter for participants that included glowing testimonials from earlier trial subjects about how much the 'therapy' and 'treatment' helped them. The newsletter also included an article informing participants that the two interventions pioneered by the investigators and being tested for efficacy in the trial, graded exercise therapy and cognitive behavior therapy, had been recommended as treatments by a U.K. government committee 'based on the best available evidence.' The newsletter article did not mention that a key PACE investigator was also serving on the U.K. government committee that endorsed the PACE therapies."
"The PACE team changed all the methods outlined in its protocol for assessing the primary outcomes of physical function and fatigue, but did not take necessary steps to demonstrate that the revised methods and findings were robust, such as including sensitivity analyses. The researchers also relaxed all four of the criteria outlined in the protocol for defining 'recovery.' They have rejected requests from patients for the findings as originally promised in the protocol as 'vexatious.'"
"The PACE claims of successful treatment and 'recovery' were based solely on subjective outcomes. All the objective measures from the trial—a walking test, a step test, and data on employment and the receipt of financial information—failed to provide any evidence to support such claims. Afterwards, the PACE authors dismissed their own main objective measures as non-objective, irrelevant, or unreliable."
"In seeking informed consent, the PACE authors violated their own protocol, which included an explicit commitment to tell prospective participants about any possible conflicts of interest. The main investigators have had longstanding financial and consulting ties with disability insurance companies, having advised them for years that cognitive behavior therapy and graded exercise therapy could get claimants off benefits and back to work. Yet prospective participants were not told about any insurance industry links and the information was not included on consent forms. The authors did include the information in the 'conflicts of interest' sections of the published papers."
"The Lancet Psychiatry follow-up had null findings: Two years or more after randomization, there were no differences in reported levels of fatigue and physical function between those assigned to any of the groups... Yet the authors, once again, attempted to spin this mess as a success."
"This study is a piece of crap."
Dr David Tuller and Julie Rehmeyer
"The study’s primary case definition for identifying participants, called the Oxford criteria, was extremely broad; it required only six months of medically unexplained fatigue, with no other symptoms necessary. Indeed, 16% of the participants didn’t even have exercise intolerance—now recognized as the primary symptom of ME/CFS".
"After the trial began, the researchers tightened their definition of harms, just as they had relaxed their methods of assessing improvement."
"[T]he study was unblinded, so both participants and therapists knew the treatment being administered. Many participants were probably aware that the researchers themselves favored graded exercise therapy and another treatment, cognitive behavior therapy, which also involved increasing activity levels. Such information has been shown in other studies to lead to efforts to cooperate, which in this case could lead to lowered reporting of harms."
"... one of the most damaging cases of bad statistical practice that I have personally encountered in my years as a journalist"
"... an object lesson in how our systems can break down. In this case there were serious breakdowns statistically, scientifically, journalistically and in public health."
"Subjective measures of sick people before & after they are repeatedly told 'You're not sick' is a social psych study, not a clinical trial."
"In 5 years, the UK medical establishment's obdurateness on ME/CFS and PACE will be taught in medical schools as a cautionary tale."
"The PACE trial is a classic case of bad science - researchers are determined to support their theory, even if the data do not."
Analysis by "citizen-scientists"
Several patients and other interested parties have produced critiques of PACE's statistical analyses and trial methodology.
Mr Courtney has written a number of published letters in the medical journals, criticising PACE.
"Chalder and colleagues acknowledge that the trial outcomes do not support the hypothetical deconditioning model of GET for chronic fatigue syndrome".
- Serious risks to clinical patient safety caused by unsound claims made about the efficacy of CBT and GET following the PACE trial;
- Gross discrepancies between research and clinical cohorts, and how clinical patients (and the physiological dysfunction associated with them) appear to have been actively excluded from PACE and other research by the research group involved in PACE, which has, ironically, caused serious resulting risks to clinical patient safety in the UK in particular;
- Related to the above, gross discrepancies in how various sets of patient criteria were used (and/or rejected), including but not limited to a changing of the London criteria by PACE authors from its original state, a set of criteria which was already controversial and problematic to start with for a number of reasons;
- Failure of the PACE trial authors to acknowledge the range and depth of scientific literature documenting serious physiological dysfunction in patients given diagnoses of ME or CFS, and how CBT and GET approaches may endanger patients in this context;
- The inclusion of major mental illnesses in the research cohort;
- The distortion by PACE trial researchers of 'pacing' from an autonomous flexible management strategy for patients into a therapist led Graded Activity approach;
- The post hoc dismissal of adverse outcomes as irrelevant to the trial, in direct contradiction to what is scientifically known about the physiological dysfunctions of people given diagnoses of Myalgic Encephalomyelitis or Chronic Fatigue Syndrome;
- The instability of 'specialist medical care' as a treatment category, and the lack of any sound category of 'control' group.
Mr Kindlon is a patient and Vice-Chairman of the Irish ME/CFS Association. He has published extensive criticism of the PACE trial. In 2011 he published a paper on harms associated with Graded exercise therapy.
Graham McPhee and Tom Kindlon
Mr. McPhee and Mr. Kindlon and others have collaborated on a set of explanatory videos about flaws in PACE's statistical analyses:
Tom Kindlon has also written a large number of letters and comments that have been published in medical journals in response to the published papers.
Among many other published letters that have been critical of the trial, many are from people who have identified themselves as patients. For example, most of the letters published by The Lancet criticising the 2011 PACE paper were from patients or representatives of patients' groups.
Dutch patient Frank Twisk of the ME-de-patiënten Foundation has also published criticism of the PACE trial.
"The PACE trial investigated the effects of CBT and GET in chronic fatigue, as defined by the Oxford criteria, not in chronic fatigue syndrome, let alone myalgic encephalomyelitis".
"[T]he positive effect of CBT and GET in subjective measures, fatigue and physical functioning, cannot be qualified as sufficient. Mean short form-36 physical functioning scores in the CBT group (62·2) and the GET group (59·8) at follow-up were below the inclusion cutoff score for the PACE trial (≤65)3 and far below the objective for recovery as defined in the PACE protocol (≥85)."
"The vast majority of patients improved subjectively by specialist medical care and APT to the same level as by CBT and GET, without any additional therapies, including CBT and GET, or by other therapies."
"[L]ooking at subjective outcomes at follow-up and objective outcomes in earlier studies, such as physical fitness, return to employment, social welfare benefits, and health-care usage, CBT and GET, like specialist medical care and APT, cannot be qualified as effective".
Principal investigators and researchers
The principal investigators on the PACE trial are Professors Peter White, Trudie Chalder and Michael Sharpe. Additional authors on the 2011 Lancet paper are Kimberley Goldsmith, Anthony Johnson, Laura Potts, Rebecca Walwyn, Julia DeCesare, Hannah Baber, M. Burgess, L.V. Clark, D.L. Cox, Jessica Bavinton, Brian Angus, Gabrielle Murphy, Maurice Murphy, H. O'Dowd, D. Wilks, and Paul McCrone.
The Trial Steering Committee members included Mansel Aylward.
List of PACE trial publications
2003: Trial Registry. BioMed Central. ISRCTN54285094
There is a currently published trial register and there is a version of the register that is no longer available on the web but has been archived. Both versions contain slightly different details. The archived version contains the details of the trial's pre-specified endpoint analyses.
2006: Final protocol version 5.0
This full version of the study protocol, which includes trial materials such as questionnaires and consent forms, was never officially published.
2007: PACE trial protocol
BMC Neurology published the trial's planned methodology, including its planned analyses.
2011: Main trial outcomes
The trial's main outcomes, and some selected secondary outcomes, were reported in The Lancet. Forty-four letters were submitted in a response that the journal's editor described as "swift and damning".
The UK and international media heavily publicised this paper after the PACE authors press conference and in conjunction with the Science Media Centre in February 2011.
                   
2012: Cost-effectiveness of CBT and GET
This paper was published in the PLoS One journal and concluded that cognitive behavioral therapy and graded exercise therapy had the best probability of being the most cost-effective treatments. The UK media publicised the results from this paper    . Controversy has broken out over the failure of the study authors to provide the underlying data to Professor James Coyne under PLoS One's data-sharing policy. Journalist David Tuller has criticized the study's assumptions and conclusions.
2013: "Recovery" rates
ME/CFS patient Graham McPhee and others created a video animation - How's that recovery? - explaining problems with the new analyses that had replaced those specified in the study protocol. Sam Carter applied the new fatigue and physical function recovery criteria to the data from the FINE trial and found that doing so increased the number of "recovered" patients six-fold, compared to the original criteria.
Patients created a tongue-in-cheek song video to satirically criticize the recovery paper results.
2013: Statistical analysis plan
Trials Journal published the detailed plan for PACE's data analysis.
2014: Adverse effects
The Journal of Psychosomatic Research published the results on safety and adverse effects.
2015: Secondary mediation analysis
2015: Long-term follow-up
The paper states that at least two years after patients were randomised, "there were no significant differences" in outcomes between the treatment groups. This indicated that APT, CBT and GET added nothing to specialist medical care (SMC), which all groups received. However, the study authors interpreted the results as favouring CBT and GET.
2015: Longitudinal mediation analysis
This short paper published in Trials Journal concluded: "Approximately half of the effect of each of CBT and GET [...] on physical function was mediated through reducing avoidance of fearful situations".
- 2014: Pain in chronic fatigue syndrome: response to rehabilitative treatments in the PACE trial
- 2013: The planning, implementation and publication of a complex intervention trial for chronic fatigue syndrome: the PACE trial
- 2013: Cognitions, behaviours and co-morbid psychiatric diagnoses in patients with chronic fatigue syndrome
- 2013: Training, Supervision & Therapists' Adherence to Manual Based Therapies
- 2011: Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale
- 2010: Psychiatric misdiagnoses in patients with chronic fatigue syndrome
Talks & interviews
- 2011: Professors Michael Sharpe and Trudie Chalder were videoed at The Lancet's press conference for the publication of the trial's main results in 2011.
- 2011: "Health Report - Comparison of treatments for chronic fatigue syndrome - the PACE trial", ABC Radio National (Australia), 18 Apr 2011
- 2015: Professor James Coyne gave a talk on "A skeptical look at the PACE chronic fatigue trial" in Edinburgh (with YouTube recording, transcript, and slides available online) and, more recently, Belfast (with YouTube recording and slides  available online
- 2016: While in Amsterdam at The Forgotten Plague Conference, David Tuller gave an interview with Frank Twisk on 27 Feb 2016. The following day, 28 Feb 2016, David Tuller gave a speech with Q&As.
- 2011, Michael Sharpe interview
- Twitter # - #PACEtrial #PACEgate
- Co-Cure Listserve (from 2003) PACE trial
- Phoenix Rising Forum PACE trial
- Wikipedia - Chronic fatigue syndrome treatment
- Wikipedia - Controversies related to chronic fatigue syndrome
- FINE trial
- The Lancet
- The Lancet Psychiatry
- Proponents of the psychological theory of ME/CFS
- Action for ME
- White, PD; Sharpe, MC; Chalder, T; DeCesare, JC; Walwyn, R; The PACE trial group (8 Mar 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, PMID 17397525, doi:10.1186/1471-2377-7-6
- White, PD; Goldsmith, KA; Johnson, AL; Potts, L; Walwyn, R; DeCesare, JC; et al. (5 March 2011), "Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial", The Lancet, 377 (9768): 823–836, PMID 21334061, doi:10.1016/S0140-6736(11)60096-2
- White, PD; Goldsmith, K; Johnson, AL; Chalder, T; Sharpe, M; PACE Trial Management Group (Oct 2013), "Recovery from chronic fatigue syndrome after treatments given in the PACE trial", Psychol Med, 43 (10): 2227-2235, PMID 3776285, doi:10.1017/S0033291713000020
- Sharpe, M; Goldsmith, KA; Johnson, AL; Chalder, T; Walker, J; White, PD (27 Oct 2015), "Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial", The Lancet Psychiatry, 2: 1067-74, PMID 26521770, doi:10.1016/S2215-0366(15)00317-X,
There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up.
- #MEAction (Oct 2015), "Petition: Misleading Claims Should Be Retracted", #MEAction
- Davis, Ronald W; Edwards, Jonathan C W; Jason, Leonard A; Levin, Bruce; Racaniello, Vincent R; Reingold, Arthur L (13 Nov 2015), "An open letter to Dr Richard Horton and The Lancet", Virology Blog
- NICE guidelines (UK) (Aug 2007), NICE guidelines (CG53) - Chronic fatigue syndrome / myalgic encephalomyelitis (or encephalopathy): diagnosis and management
- White, Peter D (2011), "Managing claims for chronic fatigue the active way", Swiss Re (insurance), archived from the original on 25 Jul 2013
- University of Edinburgh (2008), RA5a: Research environment and esteem
- "List of PACE Trial Publications", ME-pedia, 2016
- Wessely, Simon (4 Nov 2015), "The PACE Trial for chronic fatigue syndrome: choppy seas but a prosperous voyage", National Elf Service (UK)
- PACE Trial Management Group (2 Dec 2004), PACE - Manual for Doctors - Standardised Specialist Medical Care (SSMC) (PDF)
- PACE Trial Management Group (Nov 2004), PACE - Manual for Participants - Adaptive Pacing Therapy (APT) for CFS/ME (PDF)
- PACE Trial Management Group (Nov 2004), PACE - Manual for Participants - Cognitive Behaviour Therapy for CFS/ME (PDF)
- PACE Trial Management Group (Nov 2004), PACE - Manual for Participants - Graded Exercise Therapy for CFS/ME (PDF)
- McCrone, P; Sharpe, M; Chalder, T; Knapp, M; Johnson, AL; Goldsmith, K (1 Aug 2012), "Adaptive Pacing, Cognitive Behaviour Therapy, Graded Exercise, and Specialist Medical Care for Chronic Fatigue Syndrome: A Cost-Effectiveness Analysis", PLoS One, PMID 22870204, doi:10.1371/journal.pone.0040808
- Chalder, T; Goldsmith, KA; White, PD; Sharpe, M; Pickles, AR (28 Jan 2015), "Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial", The Lancet Psychiatry, 2 (2): 141-52, PMID 26359750, doi:10.1016/S2215-0366(14)00069-8
- Sharpe, M; Chalder, T (17 Feb 2011), "London Press Conference: Chronic Fatigue Syndrome - part 1 (video)", The Lancet TV
- Sharpe, M (17 Feb 2011), "London Press Conference: Chronic Fatigue Syndrome - part 2 (video)", The Lancet TV
- Chalder, T (17 Feb 2011), "London Press Conference: Chronic Fatigue Syndrome - part 3 (video)", The Lancet TV
- Guardian (UK); Sarah Boseley (18 Feb 2011), Study finds therapy and exercise best for ME
- Tuller, David (21 Oct 2015), "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study - Part 1", Virology Blog
- Tuller, David (22 Oct 2015), "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study - Part 2", Virology Blog
- Tuller, David (23 Oct 2015), "TRIAL BY ERROR: The Troubling Case of the PACE Chronic Fatigue Syndrome Study - Part 3", Virology Blog
- Reuters (17 Feb 2011), Pushing limits can help chronic fatigue patients
- WebMD (USA) (17 Feb 2011), Study Shows Cognitive Behavioral Therapy, Exercise Are Safe Ways to Treat CFS Symptoms
- BBC News (UK) (18 Feb 2011), Brain and body training treats ME, UK study says
- CNN News (USA) (18 Feb 2011), Study supports use of 2 controversial treatments for chronic fatigue
- Medical News Today (1 Feb 2013), Chronic Fatigue Treatments Lead To Recovery In Trial
- FoxNews (USA) (14 Jan 2015), Helping chronic fatigue patients over fears eases symptoms
- Guardian (UK) (14 Jan 2015), Chronic fatigue syndrome patients’ fear of exercise can hinder treatment - study
- Daily Mail (UK) (18 Feb 2011), Got ME? Fatigued patients who go out and exercise have best hope of recovery, finds study
- New York Times (17 Feb 2011), Psychotherapy Eases Chronic Fatigue Syndrome, Study Finds
- The Telegraph (UK); Sarah Knapton (28 Oct 2015), Chronic Fatigue Syndrome sufferers 'can overcome symptoms of ME with positive thinking and exercise
- #MEAction (28 Oct 2015), "PACE trial controversy grows"", #MEAction
- ME Action UK (16 Apr 2011), The Media and ME
- British Association for CFS/ME (BACME) (Mar 2011), Statement on the PACE Trial results
- ME Association (UK) (23 Oct 2013), MEA opposes plan to put review of NICE ME/CFS Guideline on hold
- NICE guidelines (UK) (Feb 2014), NICE guidelines (CG53) - Chronic fatigue syndrome / myalgic encephalomyelitis (or encephalopathy): review decision
- Centers for Disease Control and Prevention (CDC) USA (27 Jun 2012), Diagnosis and Management of Chronic Fatigue Syndrome, retrieved 10 Mar 2016
- Egeland, T; Angelsen, A; Haug, R; Henriksen, JO; Lea, TE; Saugstad, OD (Oct 2015), "What exactly is myalgic encephalomyelitis?", Tidsskr Nor Legeforen (Perspectives), 2015 (135): 1756–9, doi:10.4045/tidsskr.15.0089, lay summary
- Jason, Leonard A; McManimen, Stephanie; Sunnquist, Madison; Brown, Abigail; Furst, Jacob; Newton, Julia L; Strand, Elin Bolle (Jan 2016), "Case definitions integrating empiric and consensus perspectives", Fatigue: Biomedicine, Health & Behavior (Article), 4 (1): 1-23, doi:10.1080/21641846.2015.1124520, lay summary
- National Institutes of Health (USA) (9 Dec 2014), NIH Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (PDF), archived from the original (PDF) on 2016
- Tuller, David (30 Oct 2015), "PACE trial investigators respond to David Tuller", Virology Blog
- Davis, Ronald W; Edwards, Jonathan C W; Jason, Leonard A; Levin, Bruce; Racaniello, Vincent R; Reingold, Arthur L; et al. (10 Feb 2016), "An open letter to the Lancet - again", Virology Blog
- Juenger, J; Schellberg, D; Kraemer, S; et al. (Mar 2002), "Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables", Heart, 87 (3): 235–241, PMID 1767036
- Goldin, Rebecca (21 Mar 2016), "PACE: The research that sparked a patient rebellion and challenged medicine", Sense About Statistics (American Statistical Association) (Review of Study Design)
- #MEAction (28 Oct 2015), "What's Wrong in the Lancet", #MEAction
- #MEAction (28 Oct 2015), "What's Wrong in Psychological Medicine", #MEAction
- Courtney, Mr (29 Oct 2013), FOI Request: PACE Recovery Rates and Positive Outcome Rates (repeat request)
- Matthees, Alem (24 Mar 2014), FOI Request: Selected data on PACE Trial participants
- McPhee, Graham (28 Jul 2015), FOI Request: Fitness data for PACE trial
- Information Commissioner's Office, UK (9 Mar 2016), FOI Decision Notice: to QMUL (PDF)
- Edwards, Jonathan CW (18 Jan 2015), "(response) Re: Tackling fears about exercise is important for ME treatment", BMJ, 350: h227, doi:10.1136/bmj.h227
- Edwards, Jonathan CW (1 Nov 2015), "Prof. Jonathan Edwards: PACE trial is 'valueless'", #MEAction
- PACE Trial Management Group (Jun 2006), PACE trial participants' newsletter #1 (PDF)
- PACE Trial Management Group (Mar 2007), PACE trial participants' newsletter #2 (PDF)
- PACE Trial Management Group (Dec 2008), PACE trial participants' newsletter #3 (PDF)
- PACE Trial Management Group (Feb 2011), PACE trial participants' newsletter #4 (PDF)
- Coyne, James (29 Oct 2015), "Uninterpretable: Fatal flaws in PACE Chronic Fatigue Syndrome follow-up study", PLoS One Blog
- Coyne, James (29 Oct 2015), "Uninterpretable: Fatal flaws in PACE Chronic Fatigue Syndrome follow-up study", MindTheBrain Blog
- ME Association (UK) (29 May 2015), Our CBT, GET and Pacing Report calls for major changes to therapies offered for ME/CFS
- Dougall, D; Johnson, A; Goldsmith, K; Sharpe, M; Angus, B; Chalder, T; et al. (Jul 2014), "Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome", Journal of Psychosomatic Research, 77 (1): 20-26, doi:10.1016/j.jpsychores.2014.04.002
- Kindlon, Tom (2011), "Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome", Bulletin of the IACFS/ME, 19 (2): 59-111
- Tuller, David (7 Jan 2016), "Trial By Error, Continued: Did the PACE Trial Really Prove that Graded Exercise Is Safe?", Virology Blog
- White, PD; Goldsmith, KA; Johnson, AL; Walwyn, R; Baber, HL; Chalder, T; et al. (17 May 2011), "(correspondence) The PACE trial in chronic fatigue syndrome – Authors' reply", The Lancet, 377 (9780): 1834–1835, doi:10.1016/S0140-6736(11)60651-X
- Murray, Robin; Agardy, Susanna; Carter, Samuel; Courtney, Robert; Cox, Duncan; Maryhew, Carly; Shepherd, Charles; White, Peter (22 Jul 2013), "(correspondence) Six letters concerning the paper by White et al (2013) on the PACE Trial", Psychological Medicine, republished by ME Association UK, August 2013,
Editor: we have published six of the letters which cover the main criticisms, and invited Professor White to reply to them
- Chalder, T; Goldsmith, KA; White, PD; Sharpe, M; Pickles, AR (April 2015), "(response) Author's reply - Methods and outcome reporting in the PACE trial", The Lancet Psychiatry, 2 (4): e10–e11, doi:10.1016/S2215-0366(15)00114-5
- Sharpe, M; Goldsmith, KA; Johnson, AL; Chalder, T; Walker, J; White, PD (February 2016), "(correspondence) Authors' reply - Patient reaction to the PACE trial", The Lancet Psychiatry, 3 (2): e8–e9, doi:10.1016/S2215-0366(16)00018-3
- Kindlon, Tom (30 Aug 2013), "(correspondence) Re: College was right not to disclose deliberations about chronic fatigue treatment trial, tribunal rules", BMJ, doi:10.1136/bmj.f5355
- White, PD (25 Sep 2013), "(response) Re: People want to learn as much as possible from the PACE trial for chronic fatigue syndrome", BMJ, 347: f5731, doi:10.1136/bmj.f5731
- (various authors) (15 Oct 2013), "(31 responses) Re: PACE trial authors' reply to letter by Kindlon", BMJ, 2013;347:f5963, doi:10.1136/bmj.f5963
- Tuller, David (30 Oct 2015), "David Tuller responds to PACE trial investigators", Virology Blog
- Coyne, James (4 Nov 2015), "@Mental_Elf asked me to join PACE investigators in live debate. I agreed, they did not.", Twitter
- Tuller, David (4 Nov 2015), "Trial By Error, Continued: Did the PACE Study Really Adopt a 'Strict Criterion' for Recovery?", Virology Blog
- Tuller, David (9 Nov 2015), "Trial By Error, Continued: Why has the PACE Study's Sister Trial been Disappeared and Forgotten?", Virology Blog
- Tuller, David (17 Nov 2015), "Trial By Error, Continued: PACE Team's Work for Insurance Companies Is "Not Related" to PACE. Really?", Virology Blog
- Tuller, David (4 Jan 2016), "Trial By Error, Continued: Questions for Dr. White and his PACE Colleagues", Virology Blog
- Coyne, James (16 Nov 2015), A skeptical look at the PACE chronic fatigue trial - video part 1, Edinburgh
- Coyne, James (16 Nov 2015), A skeptical look at the PACE chronic fatigue trial - video part 2, Edinburgh
- Coyne, James (16 Nov 2015), A skeptical look at the PACE chronic fatigue trial - video part 3, Edinburgh
- Coyne, James (16 Nov 2015), A skeptical look at the PACE chronic fatigue trial - slide show, Edinburgh
- Coyne, James (8 Feb 2016), The scandal of the £5m PACE trial for ME - video
- Coyne, James (8 Feb 2016), The scandal of the £5m PACE trial for ME - slide show
- Coyne, James (25 Nov 2015), "Was independent peer review of the PACE trial articles possible?", MindTheBrain Blog
- Laws, Keith (1 Nov 2015), "PACE - Thoughts about Holes", LawsDystopia Blog
- Laws, Keith (6 Nov 2015), "PACE - Song for the Siren", LawsDystopia Blog
- Coyne, James; Laws, Keith (18 Jan 2016), "(comment) Results of the PACE follow-up study are uninterpretable", The Lancet Psychiatry
- Rehmeyer, Julie (13 Nov 2015), "Hope for Chronic Fatigue Syndrome", Slate
- Lucibee (27 Jan 2016), "My thoughts about the PACE trial", Lucibee's Blog
- Vink, Mark (30 Mar 2016), "The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review", J Neurol Neurobiol, 2 (3), doi:10.16966/2379-7150.124
- Schneider, Leonid (5 Apr 2016), "Does The Lancet care about patients?", ForBetterScience Blog
- Schneider, Leonid (8 Feb 2016), "PACE trial and other clinical data sharing: patient privacy concerns and parasite paranoia", ForBetterScience Blog
- Invest in ME (IIME) (14 Nov 2015), Letter to the Editor of the Lancet – The PACE Trial (PDF)
- Guardian (UK); Jane Colby (24 Feb 2011), ME – the truth about exercise and therapy
- List of ME/CFS articles published at Virology Blog
- http://www.microbe.tv/twiv/twiv-403/ TwiV 403
- #MEAction (Mar 2016), "#MEAction delivers Lancet petition, makes Wall Street Journal", #MEAction
- #MEAction (16 Nov 2015), "Call for HHS to Investigate Pace", #MEAction
- Guardian (UK); Robin McKie (21 Aug 2011), Chronic fatigue syndrome researchers face death threats from militants
- Wessely, Simon (27 Aug 2011), "Mind the gap - It's time to stop separating psychiatry and neurology", Spectator (UK)
- Wessely, Simon (29 Jul 2011), "Malicious' harassment of ME researchers", BBC (UK) - Today
- Zimmer, Carl (21 Aug 2011), "Chronic Fatigue Syndrome: Death threats for scientists?", Discover Magazine
- Lowe, Derek (6 Sep 2011), "Chronic Fatigue: Enough Energy Left for Death Threats, Anyway", Science Translational Medicine Blog
- The Telegraph (UK) (29 July 2011), ME researchers 'receive death threats from sufferers'
- "ME/CFS: Harassment of Researchers", Stuff and Nonsense Blog, 17 Nov 2012
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- Tymes Trust (Aug 2014), Behind the scenes: Setting up the UK CFS/ME Research Collaborative (UK CMRC) (PDF)
- Information Commissioner's Office, UK (18 Mar 2015), FOI Decision Notice: to QMUL (PDF)
- Kings College London (11 Dec 2015), FOI Request: Response from Kings College London to James Coyne (PDF)
- Sheridan, Anna (1 Nov 2015), FOI Request: Raw 6min walking test data after treatment
- McPhee, Graham (28 Jul 2015), FOI Request: Fitness data for PACE trial
- The Lancet (17 May 2011), "Editorial: Patients' power and PACE", The Lancet, doi:10.1016/S0140-6736(11)60696-X
- Swann, Norman; Sharpe, Michael; Horton, Richard (18 Apr 2011), "Health Report - Comparison of treatments for chronic fatigue syndrome - the PACE trial", ABC Radio National (Australia) - Health Report
- Kennedy, Angela (19 Nov 2012), "Statement re Simon Wessely and claims of harassment", Academia
- Tuller, David (1 Feb 2016), "Trial By Error, Continued: A Few Words About "Harassment"", Virology Blog
- #MEAction (1 Feb 2016), Tuller: PACE authors "wrapping themselves in victimhood"
- Threats of Persecution, SMC anniversary brochure page 16
- SMC Feb 2013 Supporting experts targeted by extremists
- White, PD (31 Mar 2006), Letter from Professor Peter White re Theft of patient data (PDF)
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- Rehmeyer, Julie (8 August 2016), "Rehmeyer makes statisticians' jaws drop over PACE", #MEAction
- D.G. (19 Feb 2016), "Reader's comment on Leonid Schneider's blog - PACE team disregarded the MRC data sharing policy", ForBetterScience Blog
- Coyne, James (4 Dec 2015), "Update on my formal request for release of the PACE trial data", QuickThoughts Blog
- Coyne, James (14 Feb 2016), "A call for the unconditional release of the PLOS One PACE data Part 1", QuickThoughts Blog
- PLoS One editors (7 Mar 2016), "PLoS ONE editor's notice: Update on follow up", PLoS One, doi:10.1371/journal.pone.0040808
- Coyne, James (7 Mar 2016), "Update: PLoS One affirms my (and anyone else's) right to PACE data published there", QuickThoughts Blog
- Information Commissioner's Office, UK (27 Oct 2015), FOI Decision Notice: to QMUL (PDF)
- Courtney, Mr (26 Oct 2012), FOI Request: PACE Trial Recovery Rates and Positive Outcome Rates
- Sheridan, Anna (3 Sep 2013), FOI Request: 6min walking test data - Recovered patients in PACE trial
- JohnTheJack (29 Jun 2016), "Using public money to keep publicly funded data from the public", JohnTheJack Blog
- Anderssen, Alex (9 Jul 2016), "QMUL spend £250,000 on PACE data tribunal", #MEAction
- Eliot Smith, Valerie (15 Jul 2016), "Short Update on the Progress of the PACE Trial judgment (QMUL v IC and Matthees)", ValerieEliotSmith Blog
- Information Commissioner's Office, UK (12 Aug 2016), FOI Decision Notice: to QMUL (PDF)
- Eliot Smith, Valerie (16 Aug 2016), "Tribunal orders release of PACE Trial data (QMUL v the IC and Matthees)", ValerieEliotSmith Blog
- Queen Mary University of London (QMUL) (16 Aug 2016), "Statement: Disclosure of PACE trial data under the Freedom of Information Act", QMUL website
- PACE Trial Management Group; (via FOI request) (9 Mar 2006), PACE trial protocol: Full Trial Consent Form with Missing Therapist and No Cover (PDF)
- Hooper, Malcolm (28 May 2011), "Professor Malcolm Hooper's Detailed Response to Professor Peter White's letter to Dr Richard Horton about his complaint re: the PACE Trial articles published in The Lancet", ME Action UK
- Coyne, James (11 Nov 2015), "Why the scientific community needs the PACE trial data to be released", MindTheBrain Blog
- Coyne, James (2 Dec 2015), "What it takes for Queen Mary to declare a request for scientific data "vexatious"", QuickThoughts Blog
- Coyne, James (18 Dec 2015), "King's College London stalls some more, reiterating refusal to release the PACE trial data", QuickThoughts Blog
- Coyne, James (22 Dec 2015), "Recognizing when "protecting patient privacy" is mere excuse for not sharing data", QuickThoughts Blog
- Coyne, James (2 Jan 2016), "Glimpses into the assault on data sharing", QuickThoughts Blog
- Coyne, James (31 Jan 2016), "Further insights into war against data sharing: Science Media Centre's letter writing campaign to UK Parliament", QuickThoughts Blog
- Coyne, James (20 Feb 2016), "As major medical journals balk, BMJ moves forward with routine data sharing", QuickThoughts Blog
- Coyne, James (9 Mar 2016), "UK expert: AIDS data should not be shared until requesters shown to be HIV", QuickThoughts Blog
- Coyne, James (26 Mar 2016), "'We don't share data.' Why Peter White's Wall Street Journal letter can be ignored", QuickThoughts Blog
- Davis, Ronald W; Levin, Bruce; Racaniello, Vincent R; Tuller, David (17 Dec 2015), "Open letter: A request for data from the PACE trial", Virology Blog
- Tuller, David (19 Jan 2016), "At least we're not vexatious", Virology Blog
- Emerge Australia (20 Mar 2016), Open Letter to QMUL - Request for the release of PACE trial data
- ME/CFS Australia (South Australia) (30 Mar 2016), Open Letter to QMUL - Request for the release of PACE trial data
- European ME Alliance (EMEA); ME-Vereniging (Belgium); Foreningen for Myalgisk Encefalomyelitis (Denmark); ME Foreningen (Denmark); Suomen CFS-Yhdistys (Finland); Fatigatio e.V. (Germany); Het Alternatief (Netherlands); ME félag Íslands (Iceland); Irish ME Trust (Ireland); Associazione Malati di CFS (Itali); Norges ME-forening (Norway); Liga SFC (Spain); Riksföreningen för ME-patienter (RME) (Sweden); Verein ME/CFS Schweiz (Switzerland); Invest in ME (UK) (12 Mar 2016), Open Letter to QMUL - Request for the release of PACE trial data (PDF)
- Phoenix Rising (7 Mar 2016), Open Letter to QMUL - Request for the release of PACE trial data
- Action for ME (UK) (12 Feb 2016), Open Letter to QMUL - Request for the release of PACE trial data
- Invest in ME (IIME) (12 Feb 2016), Open Letter to The Lancet - Request for the release of PACE trial data
- Invest in ME (IIME) (19 Feb 2016), Open Letter to MRC - Request for the release of PACE trial data
- ME Association (UK) (9 Feb 2016), Open Letter to QMUL - Request for the release of PACE trial data
- Tymes Trust (UK) (16 Feb 2016), Open Letter to QMUL - Request for the release of PACE trial data
- ME Research UK (18 Feb 2016), Open Letter to QMUL - Request for the release of PACE trial data
- Hope for ME and Fibro Northern Ireland (16 Feb 2016), Open Letter to QMUL - Request for the release of PACE trial data
- Welsh Association of ME & CFS Support (WAMES) (17 Feb 2016), Open Letter to QMUL - Request for the release of PACE trial data
- 25% ME Group (10 Feb 2016), Open Letter to QMUL - Request for the release of PACE trial data
- National ME/FM Action Network (Canada) (14 Feb 2016), Open Letter to The Lancet - Request for the release of PACE trial data
- Smith, Richard (16 Dec 2015), "QMUL and King's college should release data from the PACE trial", BMJ Blogs
- Coyne, James (18 Aug 2016), "Release the PACE trial data: My submission to the UK Tribunal", QuickThoughts Blog
- Gelman, Andrew (23 Dec 2015), "To keep science honest, study data must be shared", StatNews
- Wall Street Journal; Amy Dockser Marcus (7 Mar 2016), Patients, Scientists Fight Over Research-Data Access
- Anderssen, Alex (16 Aug 2016), "Tribunal orders release of PACE data", #MEAction
- The Centre for Welfare Reform (UK) (19 Aug 2016), Major breakthrough on PACE trial
- Retraction Watch (17 Aug 2016), UK tribunal orders release of data from controversial chronic fatigue syndrome study
- iNews UK; Felicity Morse (19 Aug 2016), Chronic Fatigue Syndrome sufferers have just had a small victory
- iNews UK; Paul Gallagher (19 Aug 2016), Chronic Fatigue Syndrome: tribunal orders data from controversial trial to be released
- What Doctors Don't Tell You (website) (22 Aug 2016), Researchers who claimed chronic fatigue is “all in the mind” forced to disclose data
- Edwards, Jonathan CW (27 Aug 2016), "Tribunal was right to order release of chronic fatigue trial data", The Conversation (UK)
- Anderssen, Alex (17 Aug 2016), "QMUL "studying" PACE data-release ruling", #MEAction
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