Parts one and two this series can be found here and here.
Apologies for the long gap between parts two and three, it’s been a rough few months as far as my health goes.
I left part two at the turn of the new millennium with the British biopsychosocial school in firm control over the public discourse, research priorities, and treatments offered in the UK and the lethargic pace of research and education in the US following multiple decades of bungling opportunities, muddling disease definitions and diverting research resources towards other diseases and illnesses. Research and awareness would remain in stasis as the decade began with further fumbling and public perception of the condition would remain skeptical of its “realness”, helped in no small part by high profile cultural critics such as Elaine Showalter claiming CFS to be a “hysterical narrative” and a cultural expression of the unique stresses experienced in the 20th century.
In February of 2000 the NIH held a “Chronic Fatigue Syndrome State-of-the-Science Consultation” the purpose of which was to “improve the quality [...] of CFS research” which it would fail tremendously at accomplishing. The initial plan for the conference was for only four attendees to present on the subject: Dr. Stephen Straus, Simon Wessely, Michael Sharpe and Dr. Mark Demitrack, a psychiatrist working for Eli Lily. The CFS Coordinating Committee, the group which advised the HHS on CFS had originally proposed the holding of a conference to discuss the most cutting edge research, but was not involved in the planning of the meeting and no CFSCC member was asked to participate. Patient opposition to this proposed roster resulted in three ME clinicians being invited to observe and the NIH expanding the meeting panel to 11 participants, none of whom were experts.
The resulting report suggested a slight few recommendations of biomedical research but displayed NIH’s continued focus on psychological illness, “beliefs about illness should be explored”. Cognitive Behavioural Therapy and exercise were suggested as treatments. Finally, the report suggested that the already over broad Fukuda definition of 1994 (which I remind you, lacked post-exertional malaise as a primary symptom) was too narrow and restrictive and did not reflect the true spectrum of the illness.
Controversy over the February conference lead the CFSCC to organize, and this time plan, a second conference in October 2000 to which many ME clinicians and researchers were invited. This second conference focused on biological systems, neuroendocrinology, immunology, cognition, sleep, and so on. In contrast to the February conference, the resulting report called for a need to “constrain the diagnostic criteria”, patient pools for research needed to be more restrictive, not less. Unfortunately these concerns were of little influence on the CDC’s resulting definition.
The 2003 CDC “Empirical” definition, also known as the Reeves criteria is perhaps the least well respected ME/CFS criteria among patients and biomedical researchers. It’s definitions of fatigue are vague at best calling it “unexplained [...] and a combination of non-specific accompanying symptoms”, post-exertional malaise was again absent from the criteria, subjective criteria were emphasized even going so far as to state that the presence of any objective signs “should prompt the search for alternative diagnosis”, and broadening the potential patient pool even beyond that of the Fukuda definition, the Reeves definition would even allow for primary psychiatric diagnoses of major depression to be included. A 2008 study would find that 38% of patients with major depression would be misclassified as having CFS under these “empirical” criteria.
Around the same time, the NIH moved their CFS program out of the purview of the National Institute of Allergy and Infectious Diseases, first to the NIH Office of the Director and then in 2001 to the NIH Office of Research on Women’s Health, both at the request of Anthony Fauci. This was reportedly done in order to make coordination easier across institutes, but instead the moves further marginalized the disease, implicitly marking it as psychosomatic (as women are hysterical), and making it so that no one NIH department was responsible for research or funding research.
A little further north in Canada, however, a small corrective step would be made with the publication of the Canadian Consensus Criteria, undertaken at the behest of Health Canada and free of the shadow of psychiatry. The CCC in some ways was a step back, a return to ME as opposed to CFS (indeed it was the CCC that first coined the acronym ME/CFS). Post-exertional malaise, once the hallmark symptom before being excised in the Oxford and Fukuda definitions, returned, and here it was given a definition, “an inappropriate loss of physical and mental stamina, rapid muscular and cognitive fatigability...fatigue and/or pain and a tendency for other associated symptoms [...] to worsen [...] with a pathologically slow recovery period...” In addition to PEM patients must also have experienced two or more neurological/cognitive symptoms and at least one symptom from the following categories: autonomic, immunological, and neuroendocrine. Primary psychiatric conditions were excluded, although depression was listed as comorbid. As a disease definition and diagnostic criteria the CCC would prove itself respected by patients and clinicians, offering suggestions for objective testing and potential differential diagnoses, and providing a more accurate patient pool for biomedical research. It would also provide a basis for the later drafting of the ME International Consensus Criteria, which I will return to later. The CCC is still frequently used in research, remains official definition in Canada, and has been adopted by other nations. In 2010 the Scottish Public Health Network recommended the adoption of the CCC for the clinical diagnosis of ME as it better reflected the condition’s neurological nature, Simon Wessely objected.
While progress was dire on the American side of the Atlantic, the unfolding situation in the UK can only be described as sinister. The relationship between the Wessely BPS school and the UK’s regime of austerity had been developing as early as John Major’s second term. Simon Wessely and Peter White as early as 1993 were in contact with Mansel Aylward at the Disability Living Allowance Advisory Board expressing concern that ME would be recognized as a permanent disability in the 1993 handbook and aggressively arguing for it to be classified as psychological and promoting their own brand of treatment, graded exercise therapy. According to Wessely, “the main difference between CFS and the major psychiatric disorders is neither aetiological, nor symptomatic, but the existence of a powerful lobby group that dislikes any association with psychiatry”. That same year Aylward invited Wessely to give a talk on the BPS approach to CFS to the then Minister for Social Security, Peter Lilley, during this talk it is recorded that Wessely claimed, barring any evidence to support his claim, that “it is important to avoid anything that suggests that disability is permanent, progressive or unchanging. Benefits can often make patients worse.”While this sort of claim was no doubt appealing to a Tory member of parliament, always looking to bully and abuse the vulnerable, the BPS model would not be fully embraced by the government until after the election of Tony Blair’s New Labour.
On the 6th to 8th of November 2001 a conference funded by the Department of Work and Pensions was held in Woodstock Oxford titled “Malingering and Illness Deception”. In attendance was the now Chief Medical Officer for the Department of Work and Pensions Mansel Aylward, who in 1999 as part of the Welfare Reform Act had developed the Personal Capability Assessment test used in determining the whether an individual was eligible for the Employment and Support Allowance and to what amount. The evaluation of this test was outsourced to Atos Origin where claims would be assessed by employees with no medical training and using a computer model called Logical Integrated Medical Assessment. While I do not have a figure for the initial contract in assessing claims, the contract was renewed in 2005 for £500m. From its inception the PCA made “fit to work” recommendations at an alarming rate and by 2009 two thirds of initial claimants were deemed “fit to work”. Aylward had previously worked alongside another attendee of the Woodstock conference, John LoCasio, VP of sickness and disability claims at UNUMProvident. In 1994 the pair were hired by then minister for Social Security, Peter Lilley, to devise the All Work Test for disability applicants, with approved doctors being trained in the UNUM approach to disability evaluations. In 1997 when the All Work Test was put into practice it was heavily advertised in an expensive campaign, with the text of one advert reading:
April 13, unlucky for some. Because tomorrow the new rules on state incapacity benefit announced in the 1993 autumn budget come into effect. Which means that if you fall ill and have to rely on state incapacity benefit, you could be in serious trouble
*nota bene: The already stringent All Work Test was replaced by the Personal Capability Assessment as the All Work Test had not stemmed the flow of benefits claims to a level satisfactory to New Labour reforms. The largest difference between the two was that although the All Work Test set stringent criteria for benefits, the emphasis still remained on what benefits an individual was entitled to while PCA did away with this pretense entirely, instead focusing on what work an individual might hypothetically be capable of doing, e.g. could a claimant use a keyboard and sit at a desk, with no thought given as to whether that claimant could sustain that activity for any period of time or if this might exacerbate their illness/disability. The PCA would in turn be replaced by the Work Capability Assessment which removed the final pretenses that it was assessing claimants for benefits, with claims being assessed by UNUM. The Department of Work and Pensions policy of forcing the disabled off of benefits and into work through sanctions and ableist rhetoric has lead to a situation where the rates of attempted suicide among claimants for employment and support allowance are as high as 43.2% (the rate rises to 47.1% among female ESA claimants).
In addition to Aylward and LoCasio, our usual rogue’s gallery was in attendance: Simon Wessely, lead PACE authors Peter White and Michael Sharpe, and BPS lackey Anthony David. Additionally, then Parliamentary Under Secretary of State for Work Malcolm Wicks and Wessely school psychiatrists Peter Halligan, Derick Wade and Christopher Bass would also be in attendance. This ghoulish assemblage posed for a group portrait the attendees thought it appropriate to take:
The aim of this conference’s goal was nothing less than the complete reform of the welfare system. Patients with ME/CFS would be the canary in the campaign to remove disabled people from entitlements and forcing them into the workplace through “rehabilitation”. The conference would produce a book also titled Malingering and Illness Deception which contains such charming chapter titles as “Malingering and criminal behaviour as psychopathology”, “Illness falsification in children: pathways to prevention?”, and “When the quantity of mercy is strained: US physicians’ deception of insurers for patients”. Most interesting are the chapters by Sharpe, Aylward and LoCasio titled “Distinguishing malingering from psychiatric disorders”, “Origins, practice, and limitations of Disability Assessment Medicine”, and “Malingering, insurance medicine, and the medicalization of fraud” respectively. In Sharpe’s chapter he accuses a 30yr old woman with ME/CFS of malingering based solely on the variation in her functioning day to day and uses this “case study” as an excuse to label the entire disorder psychological and accuse its sufferers of malingering. Aylward’s concerns how the biopsychosocial model can address “inappropriate illness behaviours” to protect “public funds on behalf of the taxpayer”, while LoCasio’s focuses on distinguishing malingering from fraud using such scientific measures as observing if “a person limps in public view but not when distracted or outside of public view as recorded on CCTV.”
The second outcome of the conference would be the establishment of an UNUM funded research centre in Cardiff, the Centre for Psychosocial Research at Cardiff University. Mansel Aylward would resign from his position at the DWP and take up post as the centre’s director in 2004 or 2005 (Aylward’s account differs from that of others as to his starting date). The centre would provide the academic backing for the welfare reforms that were to come with Mansel and Gordon Waddell publishing The Scientific and Conceptual Basis of Incapacity Benefits in 2005, essentially a blueprint for the 2007 Welfare Reform Act. In the book illness is modelled as a behaviour and disability considered a “conscious choice”, effort and motivation are expected to lead to recovery through compliance with CBT and graded exercise therapy. Social factors are acknowledged only as they fit the neoliberal narrative of free choice, behaviour is reinforced through entitlement culture and family support. Patients are motivated to stay sick by “secondary gains” such as attention, financial benefits, and the avoidance of obligations, a theory rooted in Freud and unfalsifiable. According to the pair, “the solution is not to cure the sick, but a ‘fundamental transformation in the way society deals with sickness and disabilities”, “the goal and outcome of treatment is work”, and “no-one who is ill should have a straightforward right to Incapacity Benefit”.
In a parallel act of consent manufacturing to provide evidence for the policy of discontinuing and denying benefits to ME/CFS patients in favour of “rehabilitation” and their forced return to work, the U.K. Medical Research Council in the summer of 2003 announced the funding of the PACE trial (more formally: “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome: a randomized trial”) the largest and most expensive to date study on ME/CFS at £5m. Unique to all other clinical trials, the bulk of funding would come from the Department of Work and Pensions. Participants were selected based on a diagnosis under the Oxford criteria (which excluded post-exertional malaise and allowed for primary psychiatric diagnoses) and two self-reported measures, the first a questionnaire developed by the RAND corporation “Medical Outcomes Study 36-Item Short Form Health Survey” or SF-36, and the “Chalder Fatigue Scale” a form developed by one of the authors, Trudie Chalder, of eleven questions scored 0 or 1. A score of 60 or less on the SF-36 and a score of 6 or more on the Chalder scale would be considered sufficient evidence for entry into the study. The 631 subjects selected for the study would be randomized into four groups.
All four groups would be offered meetings with a “medical specialist”, with three of the groups receiving additional sessions up to a possible fourteen sessions over six months. One group would receive CBT, another GET, and a third group what the authors termed “adaptive pacing” an altered and watered down variant of what’s known as “pacing” among patients. The goal of pacing being as to not exceed one’s energy envelope, it had a technique that had long been circulating in patient support circles. The study would commence in 2005. Home or bed-bound patients were not eligible as participation would require attendance at multiple clinic sessions. The effectiveness of GET and CBT with home and bed-bound patients would instead studied with the FINE trial (formally: “Fatigue Intervention by Nurses Evaluation”); the FINE trial would follow nearly the exact same procedures as the PACE trial only with interventions delivered in the patients’ homes.
Already one can see the flaws in the PACE trial before reading its conclusions: the exclusion of the most severely affected ME/CFS patients, the inclusion of large numbers of patients with a primary diagnosis of major depression who would not otherwise meet the more stringent requirements under something like the Canadian Consensus Criteria, the lack of a true control i.e. patients who would receive no intervention at all, and the complete reliance on subjective measures.
The results of the FINE trial would be published in 2010 and conclude that CBT and GET were of limited effectiveness in the short-term in treating ME/CFS but had no sustained long term effect:
“Pragmatic rehabilitation delivered at home by trained general nurses over a period of 18 weeks improved fatigue, sleep, and depression among patients with CFS/ME, but these effects were not maintained in the long term once treatment was completed. Supportive listening delivered by trained general nurses was not an effective treatment for CFS/ME in primary care. More studies are needed to determine the optimal conditions under which pragmatic rehabilitation can be delivered to patients in the community with CFS/ME and whether the limited benefits seen in this trial can be sustained.”
The FINE trial results would be largely buried by the media, forgotten for years until after the release of the full PACE trial data (one patient advocate, however, applied the criteria of the PACE trial to the result data of the FINE trial leading her to wonder whether the recovery rates of the PACE trial had been inflated as much as six-fold, the only way in which she would prove to be wrong was to the degree of the fraud).
The quiet suppression of the FINE trial in the media following its publication and its failure to achieve any of the stated goals is perfectly contrasted by the media attention received by the PACE trial and the announcement of its “success”. On February 27th 2011 the PACE trial paper was published in the Lancet with Michael Sharpe and Trudy Chalder holding a press conference to announce their findings. At the conference Chalder announced that “twice as many people on graded exercise therapy and cognitive behaviour therapy got back to normal”, a gross overstatement of their own results, the first inkling that results had been overstated. Reports in Reuters, the BBC, CNN, The Daily Mail, and The New York Times would trumpet the claims of recovery in the PACE trial. The British Medical Journal would claim that some patients were “cured”. Many of these news reports, particularly those in the U.K. would have been mediated and guided by the Science Media Centre, ostensibly an impartial charitable organization formed following a House of Lords report on the state of science understanding in society in 2000, in reality the SMC functions as a dark money funded public relations firm laundering its corporate backers public perception. Which has ideological and personal spillover from the Living Marxism clique/Revolutionary Communist Party (UK). Before getting into the stated results of the PACE trial I want to first take a look at these groups.
Like every other contrarian Trotskyist sect (see also: the LaRouche movement, the SDUSA members who founded the neoconservative movement and got positions in the George W. Bush administration), the Revolutionary Communist Party was quick to abandon leftism but clung to their contrarianism. These contrarian opinions would find their mouthpiece in Living Marxism magazine, and concerned everything from AIDS, “the dangers from AIDS have in fact been grossly exaggerated. The principal threat to homosexuals in Britain today is not from AIDS, but from the safe sex campaign." to sanctions against apartheid South Africa, to denouncing environmentalism and the European Convention on Human Rights. Eventually this contrarianism would result in the shuttering of Living Marxism on account of their views concerning genocide.
In 1995 Fiona Fox would write an article denying the Rwandan genocide, in 1997 her editor Mick Hume would go further publishing an article by a German journalist claiming that broadcaster ITN had fabricated their evidence of genocide during the Yugoslav wars and misrepresented the Bosnian genocide. ITN would sue for libel resulting in the shutdown of Living Marxism in 2000. This would do little to stop the clique as Spiked! magazine would its place the following month, and anyways, the name Living Marxism no longer made any coherent ideological sense at all. Spiked! would often serve as a mouthpiece to Wessely and his confederates e.g. this article now scrubbed from their live website with Wessely himself writing articles on occasion (e.g. this article claiming that health issues were caused by overly paranoid attitudes to our environment) in addition to maintaining a mailbox at their offices. As for the RCP/Living Marxism/Spiked! ties to the Science Media Centre, it just so happens that one of our genocide deniers would find herself named as its director (Wessely also listed as a co-founder sitting on their science advisory panel).
When the SMC was established Fiona Fox was named its director for reasons that are entirely unclear, as she has no science background and her previous media work was entirely for a magazine forced to shutter on account of genocide denial and libel. Whatever the reason for her appointment the work of the SMC as it came to ME/CFS would only seek to legitimize BPS model in the public’s imagination, uphold any research produced by the group, and also paint critics as backwards anti-science partisans no different from anti-vaccine activists. Indeed editors of broadsheet newspapers in the UK have all but confirmed it was editorial policy to only publish those items on ME/CFS which came from the SMC. Examples of influence conflicts abound such as this Rod Liddle column initially published in the Sunday Times. Liddle would follow this up years later with a column comparing ME/CFS sufferers to those claiming to have Morgellons *note: paywalled. Why Liddle would express any interest in ME/CFS can only be explained by the parent company of The Times having funded the Science Media Centre and having one of its assistant editors sit on the SMC advisory committee.
Perhaps the best illustration of the conflicts of interest frequently undertaken by the Science Media Centre not just concerning ME/CFS are the following articles from a single reporter, Kate Kelland. In a 2019 article for Reuters she publicized purported (read: utterly fabricated) threats against Michael Sharpe from ME/CFS patients and had eight years earlier produced nothing but uncritical praise for the PACE trial. She had also previously come under scrutiny for downplaying the link between cancer and a weedkiller produced by Monsanto, another entity which had funded the SMC, and on yet a another separate occasion written a piece downplaying the environmental and health impact of fracking with Shell and BP having previously given sizable grants to the SMC.
As for Fiona Fox’s own personal views on ME/CFS, this incredibly odd and off-putting quote seems to suggest that she at one point believed it possible to inoculate oneself from ME/CFS through faith and loyalty to the Revolutionary Communist Party:
Every time I feel myself slipping into despondency I just think of Carol. Carol was my first boss and I really liked her. The only daughter of a docker and dinner lady from Sunderland, Carol had made good. When I first met her she was active on the left of her local Labour party, Head of Press at the Equal Opportunities Commission, and in love. But things went wrong for Carol. Labour lost the election, the Government appointed a Tory activist to run the EOC and Carol’s lover left her. She went into counselling only to learn that the cause of her unhappiness was her father’s inability to hug her as a child. Weeks after confronting him, Carol’s father dropped dead. She is now in counselling two days a week and spends the rest in reflexology and aromatherapy sessions. She has had the last year off work with ME.
There are plenty more like Carol and I hope I’m not bastardising the present OTAM debate if I often think “there but for the grace of the RCP go I”. This secret thought is even present with I meet up with those mates who have dropped out of RCP politics. Slowly but surely they have lost the framework for understanding the world and I flinch when I discover they too are becoming suseptible [sic] to what James calls the ‘false critique’ of society (not to mention the joys of natural childbirth and alternative methods of childrearing!!!![sic])
As to the actual results stated in the PACE trial, the authors assessed an improvement as an increase of at to a score of 75 or a 50% increase over the initial baseline on the SF-36, and a reduction on the Chalder Fatigue score to 3 or a 50% reduction from baseline. According to the results, 76% of participants improved with the use of CBT and 80% improved after receiving GET, results were so outstanding that some patients were considered fully recovered if they scored 85 or more on the SF-36 with a fatigue score of 3 or less, as well as a score of 1 out of 7 on the Clinical Global Impression scale and who no longer met the criteria for the case definitions used in the study with 22% of the CBT and 22% of the GET patients meeting this mark. In addition CBT and GET were announced as safe contrary to the testimonials of dozens, if not hundreds patients who had been subject to iatrogenic harm as a result of these treatments. But these are all subjective results, and as self-reported questionnaires the data from these answers could have been easily influenced by everything from how much a patient liked a therapist or how much they wanted the treatment to work.
The trial had promised objective results, and the objective results in physical capacity and function were: a six-minute walking test, a self-paced step-test on a short stool, and data on employment, wages, and received benefits. The results of the walking test was hailed in the study as almost miraculous with CBT patients able to walk a full 354m and GET patients 379m in the six minute walking test a seeming increase of nearly 100m for both groups. Except the mean performance of a 70-79 year old woman is 490m, those with Class II heart failure 558m and cystic fibrosis patients 626m. Three quarters of the PACE participants were women and the average age was 38. There were other oddities as well, the paper outlining the protocol for the study had called for a score of 60 or less on the SF-36 for an individual to be considered a participant, but the final paper changed this cut off to 65 mid trial, rendering a full 13% of study participants to be considered already improved at the beginning of treatment. The parameters of the fatigue scale were also changed post-hoc from a binary 0/1 to a modal 0-3 scale. These breaks from the scientific protocol raised alarm bells for many patient activists and researchers who were investigating ME/CFS from a biomedical angle.
In addition to the problematic results, the trial was plagued with other conflicts and issues, a December 2008 newsletter on the trial website included praise from then Prime Minister Gordon Brown and articles on the government’s new guidelines for treatment which were advertised as being based on the best available evidence, the treatments being GET and CBT, the very treatments under study, nor was it mentioned that one of the PACE authors had served on the committee that endorsed the new guidelines. The same newsletter included testimonials from participants on the positive outcomes of their treatment while the study was still underway, an unprecedented case in the history of clinical trials.
Something was wrong with this study. Malcolm Hooper submitted a 43-page complaint to the Lancet calling the study “unethical and unscientific” this was, of course, summarily rejected. In addition to Hooper’s mammoth complaint (which is a full thirty pages longer than the PACE trial paper itself) the Lancet received 44 formal letter submissions critiquing the secondary outcomes, questioning the shifts in protocol and the generalisability of the study. The Lancet chose to vigorously defend the study publishing only eight of the milder of the critiques, a rebuttal from White, Sharpe et. al. and a statement from the editor:
Patients' power and PACE, The Lancet, May 17th 2011
...one cannot help but wonder whether the sheer anger and coordination of the response to this trial has been born not only from the frustration many feel about a disabling condition, but also from an active campaign to discredit the research. White and colleagues have been accused of having “formed their opinion about the intended outcome” before the trial began. This view is unjustified and unfair. The researchers should be praised for their willingness to test competing ideas and interventions in a randomised trial. The evidence might even suggest that it is the critics of the PACE trial who have formed their opinions first, ignoring the findings of this rigorously conducted work.
The editor of the Lancet, Richard Horton, would then go on to state on Australian radio, “One sees a fairly small, but highly organized, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients”. Despite repeated critiques the PACE authors gave no ground, defending their mid-trial revisions of participant requirements and post-hoc alteration of normal ranges. Amid all this controversy and push-back a flurry of articles which would attempt to paint ME/CFS activists as dangerous radicals who sent death threats against the very researchers who were only trying to help them, and who are too stupid and radicalized the harm they do to themselves in publications as left leaning as The Guardian to as right-wing as The Telegraph would appear.
*nota bene: A similar round of articles employing the same tactics would appear some eight years later in 2019 during the Parliamentary hearings into the PACE trial in everything from The Daily Mail to The Sunday Times (paywalled) to the Reuters article mentioned previously.
A follow up paper in PLoS One from 2012 on the financial aspects of the illness included more of the objective outcomes promised, instead of a decrease in benefits that one would expect from patients who had improved or even “recovered” the paper reported an increase in the receipt of benefits across all four groups, more contrary data. The promised data on wages was never included, additionally the results of the self-paced step-test had yet to be published.
Then in 2013 in the journal Psychological Medicine was published featuring the findings on “recovery”, i.e. those patients who had improved enough from their baseline as to be considered recovered. This too introduced a new wrinkle, “recovery” was now defined solely as improvement following the most recent episode, a limitation not included in the PACE protocols. Psychologist Fred Friedberg from Stony Brook University criticized this definition as inaccurate as it did not refer to recovery over a long period, in his view the term “remission” was more appropriate and less prone to exaggeration and misinterpretation. And just like the original Lancet paper, the 2013 paper shifted the goalposts measuring improvement, and criteria for recovery in the new paper were also revised. Under the new metric for physical function “recovery” required a score of 60 or more on the SF-36, in the protocol “recovery” had required a score of 85 or more, now consider how a score of 65 or less had been the initial requirement for study participants, thus the entry threshold of 65 now indicated better health over the new “recovery” threshold of 60. The required score on the fatigue scale was similarly revised so that patients would be considered “recovered” before even starting the protocol. Despite the irregularities relating to protocol and criticism, like the original Lancet paper, the new 2013 paper received broad, uncritical coverage in the media.
Each new paper based on the PACE study data only fuelled new questions, as each was less congruent with what had initially been presented. Dozens of freedom-of-information requests were filed for the PACE data with Queen Mary University of London, some of these requests were granted. One response revealed that 85 participants, or 13% of the total sample were already considered recovered or in the normal range even as they qualified as disabled enough for the study. Most requests, however, were shut down. Anna Sheridan, a patient with a Ph.D. in physics requested data on the “recovered” patients performance on the six-minute walking test. The University summarily rejected the request as vexatious, on appeal the university re-reviewed the request and ruled that it was indeed, not vexatious, but was still denying her request on the grounds that the resources required to locate and retrieve the information were not available.
In 2015, the same year the CDC in the US would fully abandon the psychosomatic hypothesis in an IOM report and attempt to rebrand ME/CFS as SEID or Systemic Exercise Intolerance Disorder (more on this in Pt. IV), the PACE authors published a paper on the “mediators of improvement” in The Lancet Psychiatry which stated that reducing patients’ fears of activity was the main mechanism by which the rehabilitative treatments of GET and CBT could deliver their benefits. A new round of media articles on how patients with ME/CFS could cure themselves if they rid themselves of their fears of exercise appeared. Later that year scientists James Coyne (Professor Emeritus of Psychology at University of Pennsylvania) Ronald Davis (Professor of Biochemistry and Genetics at Stanford University), David Tuller (Senior Fellow in Public Health in Journalism at the Center of Global Public Health at UC Berkeley), Bruce Levin (Biostatistic Professor at Columbia University) and Vincent Racaniello (Higgins Professor of Microbiology and Immunology at Columbia University’s College of Physicians and Surgeons) requested the PACE trial data. Their request was denied.
Finally in 2016, an Australian ME/CFS patient Alem Matthees who on March 24th 2014 submitted a FOIA request to the PACE trial authors had his request miraculously granted. At last, the PACE authors were obliged to provide the requested data by the Information Commissioner’s Office. White, Chalder, Sharpe and the others appealed the decision and a three day hearing was set for April 20th 2016. At the hearing the expert witness on the side of the PACE authors was called to speak on the topic of data security. Professor Ross Anderson’s strategy was to attack and defame the activists who sought the data as “young men, borderline sociopathic or psychotic” who would “attempt to identify and seek out trial participants from anonymized data and do them harm.” And for all the wild claims in the media about death threats against researchers, the only actual evidence of harassment was a single incident attested to by Trudy Chalder wherein she was heckled at a seminar by a single individual.
The their judgment tribunal found that the “assessment of activist behaviour was, in our view, grossly exaggerated” and consisted of a “considerable amount of supposition and speculation, with no actual evidence to support [...] assertions or counter the respondents arguments.” Anderson’s “wild speculations” of “borderline sociopathic or psychopathic” young men backfired and in the eyes of the tribunal "did him no credit”. Moreover it was admitted that the independent Cochrane review of the data did not count as a disclosure to independent scientists as all three principal authors of the PACE trial sat on the review panel. The day the hearing ruled in favour of Matthees, Queen Mary University of London released a statement, “we are studying the decision carefully and considering our response”, in response to this statement an open letter in support of Matthees signed by many top biomedical researchers was issued urging them to release the data and make no further resistance.
Queen Mary relented, the data was released. It would be some months before the entirety could be reanalyzed. In the summer of 2016 Professor Jonathan Edwards of University College London posted an editorial in the Journal of Health Psychology stating that the Pace trial was “an unblinded trial with subjective outcome measures. That makes it a non-starter in the eyes of any physician or clinical pharmacologist familiar with problems of systematic bias in trial execution.” In the fall of 2016 the first re-analysis was published informally on David Tuller’s Virology blog, and in December 2016 the first journal article based on a reanalysis of the data would be published, Alem Matthees would be listed as one of the co-authors. The findings of the reanalysis would prove shocking, not only had the PACE trial authors consistently moved the goalposts for what they considered improvement, their claims as to the safety of CBT and GET would prove entirely erroneous, and of the data, that which hadn’t been massaged and presented misleadingly had in some cases been outright fabricated. Rather than engage with critics, the PACE authors changed their guidelines for those requesting access to the PACE data in January 2017 further restricting access by requiring "formal agreement" with "precise analytic plans, and plans for outputs". Matthees after all his exertion and work in exposing the fraud experienced a steep decline in his condition and was left bed-bound by the end of the ordeal.
Media coverage was quite extensive, albeit, with a majority of the most in depth coverage initially coming from publications located outside of the U.K. In a moment of serendipity, however, the release of the PACE data coincided with the release of Jen Brea’s documentary film Unrest which allowed for U.K. journalists to discuss the PACE data and indicate that ME/CFS was likely a biological disorder under the guise of a film review and thus place them beyond the Science Media Centre’s stranglehold over science journalism.
I’ll pause things here, it’s gone on longer than I expected and I've just about hit the post character limit. In Pt. IV I’ll first briefly touch on the 2015 IOM report for the CDC which introduced the acronym SEID and spelled the end of the psychosomatic consensus in the U.S. After that I’ll pick up the narrative with the fallout of the PACE trial scandal including exactly what the reanalysis of the data revealed. I’ll also discuss the counteroffensive launched by the BPS proponents and the SMC which beyond the renewed claims of harassment and death threats against researchers would include an attempt to replicate the glowing media profile of PACE with a new study, this time using child participants. It would be a study that appeared truly desperate and ludicrous on its face in its use of something known as “the Lightning Method” as its therapeutic method. "The Lightning Process" being a copyrighted blend of neurolinguistic programming and graded exercise therapy invented by a man who believes he possesses the ability to psychically enter the bodies of others and heal them (the SMILE study; I don’t know what it is with BPS people and acronyms). I’ll also discuss the calls for a Parliamentary hearing on the scandal in 2018 which were typified by MP Carol Monaghan’s prediction, “When the full details of the trial become known this will become known as one of the biggest medical scandals of the 21st century.” And relate how these Parliamentary hearings would result in a new set of treatment guidelines published by NICE in 2021 and how the BPS school have fought their implementation to this day, published a critique just this month (a 4,000 word wet fart of a paper with a 1,500 word conflict of interest disclaimer). I’ll also discuss how this entire ordeal should have been the death knell for the careers and credibility of everyone in the BPS camp if not for the arrival of SARS-COV2 and appearance of the first cases of Long Covid after which Wessely, White, Sharpe, Chalders et. al. would find new lease by pivoting to Long Covid but offering nothing but the same, stale causes and cures, but now under the new moniker of “Functional Neurologic Disorder”. Pt. IV will be followed by an addendum consisting of a bibliography which will list and share the full range of sources I’ve consulted in writing these posts.
