Personality and Fatal Diseases: Revisiting a Scientific Scandal

During the 1980s and 1990s, Hans J Eysenck conducted a programme of research into the causes, prevention and treatment of fatal diseases in collaboration with one of his protégés, Ronald Grossarth-Maticek. This led to what must be the most astonishing series of findings ever published in the peer-reviewed scientific literature with effect sizes that have never otherwise been encounterered in biomedical research. This article outlines just some of these reported findings and signposts readers to extremely serious scientific and ethical criticisms that were published almost three decades ago. Confidential internal documents that have become available as a result of litigation against tobacco companies provide additional insights into this work. It is suggested that this research programme has led to one of the worst scientific scandals of all time. A call is made for a long overdue formal inquiry.

Read paper at:

https://journals.sagepub.com/doi/full/10.1177/1359105318822045

Polyfilla Science

Screen Shot 2019-11-04 at 19.50.03.pngGap Filling

Like any other science, Psychology contain myriads of variables, A,B,C…N…X,Y,Z.  An established strategy for developing new research is for the investigator to identity ‘gaps’ in the field and to set about filling those gaps with correlational and experimental studies. The latter involve almost every possible permutation and combination of variables.

The gap filling approach is one strategy for keeping productivity high but, often, it is at the expense of developing new theories. There are more than 5 million publications listed by Google Scholar that address a gap in the literature. Another five million address theoretical integration.

Guaranteed Results

The academic world is based on quantitative measures of performance and the number of publications a researcher can claim matters [1]. This drive towards publications leads to what I call ‘Polyfilla Science’. You’ve used it, I’ve used it, everybody’s used it. It does the job perfectly well.  For every ‘hole’ investigators fill, they are almost guaranteed a peer-reviewed publication. ‘Polyfilla Science’ exists on an industrial scale, keeping hundreds of thousands of scientists busily occupied in hot competition. The ‘winners’ of the Polyfilla competition are the ones who tick the highest number of boxes and harvest the most citations.[2]

‘Polyfilla Science’ can be represented as a multidimensional matrix of cells where the task of science is viewed as filling every last cell in the matrix (see Figure).  This method of doing science is more akin to a fairground shooting gallery than to theory-driven science.  In the absence of theory, many researchers use a Polyfilla ‘shotgun’ by testing a dozen or more “hypotheses” in one shot. Popular though it is, ‘Polyfilla Science’ isn’t the only game in town, and a theory-driven approach is also available.  Theory is used to identify the principles behind questions that need answering in a process of confirmation and disconfirmation of predictions. When one considers the fact that there are one hundred thousand psychology majors in the US alone, all needing a research project, it is no wonder the Polyfilla approach is so popular.

Never-ending Process

It doesn’t matter how may gaps and holes you plug, new ones always appear.

In comparison to the scientific discoveries in other fields, Psychology has made no world-changing discoveries in the last 50 years. By this, I mean discoveries that are worth telling your grandchildren. In my opinion, the lack of significant theoretical developments, and the Polyfilla Approach, are two of the main reasons for this lack of progress.  All this needs to change.

[1] Numbers of publications, citations, grant monies, prizes, promotions and awards.

[2] One of the world’s most published and ambitious ‘Polyfilla’ psychologists told me a self-effacing story about the occasion he went for an interview at the University of Oxford. A member of the panel asked: “Dr X, you have a huge number of publications. But what does it all mean?” He didn’t know the answer and got rejected for the post.

[3] Polycell Multi-Purpose Polyfilla Ready Mixed, 1 Kg, i#1 best seller on Amazon.co.uk, 16 May 2019.

 

A New Ponzo Illusion (or something more?)

Most visual illusions are produced using carefully contrived drawings or gadgets to fool the visual system into thinking impossible things.  Recently,  waiting at a train station, I encountered a real-life Ponzo illusion.

The Illusion

The traditional form of the Ponzo illusion is produced by drawing a pair of receding railway lines. The context suggests different depths in the drawing. An object towards the top of the drawing appears larger than an identical object near the bottom of the drawing.  Using a principle of size constancy, the visual system estimates the size of any object as its retinal size multiplied by the assumed distance. Thus, the ‘most distant’ of the two identical yellow lines appears to be longer.

Ponzo_illusion

The Setting

The setting of this new Ponzo illusion is a railway station situated at Vitrolles Airport, Marseille (see photo below).  The station has glass panelled shelters on the platforms on each side. The glass panel at the front of each shelter displays two rows of grey rectangles. Apart from their decorative function, one assumes that these rows of rectangles are intended to help prevent people from walking into the glass panel as they move in and around the shelter. The photo below shows the arrangement of the two rows of rectangles on the shelter.

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The Stimuli

The stimuli for the illusion consist of rectangles that are slightly longer than a credit card, approximately 10.0 cm long x 1.5 cm wide with a separation of about 3.0 cm between successive rectangles. The plate glass window is about 5 mm thick and is marked with rectangles on both sides of the glass in perfect alignment so that a 3-D effect is created indicating a false sense of solidity to these rectangles. This ‘3-D look’ may strengthen the Ponzo effect illustrated below.

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The Illusion

The illusion is demonstrated in the photo below.  Two people sitting directly in front of the shelter are waiting for a train. The upper set of rectangles appears as a set of columns positioned along the railway lines at a distance of approximately 7 metres in front of the two passengers. In this case, the upper set of rectangles appear to have a height of around 2-3 metres. The lower set of rectangles are perceived at their correct location and size on the plate glass window, behind the two passengers. The lower set are actually physically smaller, owing to the camera angle, but the illusion exaggerates the size difference enormously.

IMG-9431.JPG

Further illustration of the effect indicates how the brain scales the stimuli to the context. When the rectangles are projected onto the opposite platform they appear huge – almost as high as the lamp post of around 5 metres.

When the rectangles are projected onto the nearby platform, however, they appear proportionately smaller (1.0-1.5 metres).

IMG-9388z

IMG-9389.JPGOwing to the camera angles, the actual size of the rectangles in the upper picture is larger (5-10%) than in the lower picture, but nowhere near the illusory ‘expansion’ that takes place when they are projected by the brain to the opposite platform.

Blocking the Distance Cues

The magnitude of the Ponzo illusion becomes somewhat indeterminate when the distances cues were fortuitously blocked by a passing freight train. In this case the rectangles are ‘drawn into’ the scale of the passing wagons, stretching in size beyond the appearance when the wagons are not there.

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Explanation

The Ponzo illusion can be most easily explained in terms of linear perspective. The rectangles look longer when they are projected to the distance of the opposite platform because the brain automatically interprets them as being further away, so we see them as longer. An object located farther away would have to be larger than a nearby object to produce a retinal image of the same size.

PONZO.png

The more visual cues surrounding the two vertical lines, the more powerful the illusion. The passing freight train obliterated some of the distance cues and so the length of the lines was more difficult to assess.

A new post explores the possibility that the illusion described above may be more than another form of the Ponzo Illusion. 

The Strange Self-Motion Illusion

Anomalous experiences tend to jolt one out of one’s comfort zone, tell us interesting things about how the mind works.  A vivid déjà vu, strange coincidence, or unexpected illusion can all be automatic attention-grabbers.  Some of the oddest experiences are visual. When a large part of the visual field moves, the viewer can momentarily believe that they have moved in the opposite direction.

The most common example occurs when looking out of a stationary train window at a station, and a nearby train moves away, you erroneously perceive that your own (stationary) train is moving in the opposite direction. This experience can happen on the railway, the road, at sea or in space, and it can cause accidents (e.g. see https://safety4sea.com/relative-motion-illusion-leads-to-collision/).

The other day, driving along a busy A3 towards London on ‘autopilot’ (Vatansever, Menon and Stamatakis, 2017), I reached a  set of traffic light. In the middle lane, my vehicle was boxed in all sides by other vehicles so that I could not myself see the traffic lights. Suddenly I felt as if my vehicle was being pulled backwards so that my car would impact the one behind, a potential disaster.  I immediately slammed my foot on the brake and felt a surge of adrenaline. Thankfully, my perceptual-motor system quickly snapped back to reality – I realized that I was stationary and that the surrounding vehicles were moving forwards.  Reset! In less than a second, my foot came off the brake and onto the accelerator.  I had experienced the ‘Self Motion Illusion’ (Riecke, 2010).

My brain had falsely concluded that my vehicle was moving backwards. This is the natural response of a perceptual system with a default setting that expects constancy (Day, 1972).  I wish to argue that perceptual constancy is based on a universal principle of ‘Psychological Homeostasis’ (Marks, 2018).  When my perceptual world went haywire at the traffic lights, a rapid correctional ‘reset’ brought me back to my senses.

The rapidity of the reset is required to prevent a potential accident. This fact may be evidence of a general reset principle which is operating to produce equilibrium at each and moment in a conscious being.  Alternatively the experience was reset by the fact that I saw the surrounding vehicles moving away around me. It is hard to say from a single uncontrolled experience.

References

Day, R. H. (1972). The basis of perceptual constancy and perceptual illusion. Investigative Ophthalmology & Visual Science11(6), 525-532.

Marks, D. F. (2018). A General Theory of Behaviour. London: SAGE Publications.

Riecke, B. E. (2010). Compelling self-motion through virtual environments without actual self-motion–Using self-motion illusions (‘vection’) to improve VR user experience. Virtual reality. InTech.

Vatansever, D., Menon, D. K., & Stamatakis, E. A. (2017). Default mode contributions to automated information processing. Proceedings of the National Academy of Sciences114(48), 12821-12826.

 

 

 

Psychology and the Paranormal

“There are more things in heaven and earth, Horatio, than are dreamt of in your philosophy.”

Thanks for the visit!

I approach this blog site with a sense of anticipation, wondering where it may lead…

I hope it might lead towards light, new treasure, in the form of new knowledge and theory.  

How can that be, you might well ask ?  Surely, a so-called ‘expert’ must already have an opinion one way or the other about the paranormal? Wrong!

The truth is that I have no fixed ideas about which direction the evidence will lead. 

One thing I do know – it is necessary to step beyond old assumptions, seek new objects of knowledge. 

If we already KNOW the answer, the TRUTH, why would we bother to read, write or even THINK for that matter, because the truth must already be determined, already out there, written by somebody, somewhere and all that would be left to do would be to pick up dead learning.

Believers vs. Disbelievers

It is quickly apparent to any observer that the paranormal field is heavily divided between two armies of believers (so-called ‘sheep’) and skeptics (so-called ‘goats’ who are actually dis-believers) battling it out with no holds barred.

The stakes are high. The fight is not about empirical studies, observations and anecdotes.  The very nature of science, life and reality are being contested.  

There are ‘dead bodies’ and ‘unexploded land mines’ all over the place and one would be lucky to leave the field in one piece. One can surmise that there can only be losers, never winners, in this futile type of war. In the end every soldier in the affray is a loser. It’s an intellectual version of World War I with permanent trenches and barbed wire fences that has been waging for over a century.  

I know this because I have been there on the battle field.  I entered the field and did several tours of duty. Then, battle-weary with the affray, I walked away.

Recently I returned to see if anything has changed.

As I stuck my head over the trench top waving a white flag of peace, a few warning shots were fired. The same old battle is raging but with the difference that many new foot soldiers have been recruited and there have been scores of  new studies over the last 20 years. These studies have been weaponised to provide increased power, precision and impact.

The army of non-believers now possesses a stockpile of findings consistent with scientific explanations of the paranormal. The believer army, meanwhile, has accrued an equally large stockpile supportive of paranormal interpretations.  

White Flag of Neutrality

Offering the white flag of peace and neutrality causes no small amount of trepidation.  Am I now to be a target for both sides – because, in the battle of the paranormal, nobody is permitted to be neutral?  It’s a ‘do or die’ scenario like no other in science.

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The blog posts here are written from a dispassionate point of view. If I am passionate about anything, it is about the importance of neutrality. My purpose is to create a balanced and even-handed review based on the best contemporary evidence on paranormal claims in science and medicine.

I present here the evidence, both pro and con, explain the relevant psychological processes, present scientific arguments, and produce a final balance sheet at the end.

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Out soon:

“Psychology and the Paranormal

Exploring Anomalous Experience”


June 2020 | 400 pages | SAGE Publications Ltd

 

 

 

Special issue on the PACE Trial

We are proud that this issue marks a special contribution by the Journal of Health Psychology to the literature concerning interventions to manage adaptation to chronic health problems. The PACE Trial debate reveals deeply embedded differences between critics and investigators. It reveals an unwillingness of the co-principal investigators of the PACE trial to engage in authentic discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5million) on what is a textbook example of a poorly done trial.

The Journal of Health Psychology received a submission in the form of a critical review of one of the largest psychotherapy trials ever done, the PACE Trial. PACE was a trial of therapies for patients with myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS), a trial that has been associated with a great deal of controversy (Geraghty, 2016). Following publication of the critical paper by Keith Geraghty (2016), the PACE Trial investigators responded with an Open Peer Commentary paper (White et al., 2017). The review and response were sent to more than 40 experts on both sides of the debate for commentaries.

The resulting collection is rich and varied in the perspectives it offers from a neglected point of view. Many of the commentators should be applauded for their courage, resilience and ‘insider’ understanding of experience with ME/CFS.

The Editorial Board wants to go on record that the PACE Trial investigators and their supporters were given numerous opportunities to participate, even extending the possibility of appeals and re-reviews when they would not normally be offered. That they failed to respond appropriately is disappointing.

Commentaries were invited from an equal number of individuals on both sides of the debate (about 20 from each side of the debate). Many more submissions arrived from the PACE Trial critics than from the pro-PACE side of the debate. All submissions were peer reviewed and judged on merit.

The PACE Trial investigators’ defence of the trial was in a template format that failed to engage with critics. Before submitting their reply, Professors Peter White, Trudie Chalder and Michael Sharpe wrote to me as co-principal investigators of the PACE trial to seek a retraction of sections of Geraghty’s paper, a declaration of conflicts of interest (COI) by Keith Geraghty on the grounds that he suffers from ME/CFS, and publication of their response without peer review (White et al., 4 November 2016, email to David F Marks). All three requests were refused.

On the question of COI, the PACE authors themselves appear to hold strong allegiances to cognitive behavioural therapy (CBT) and graded exercise therapy (GET) – treatments they developed for ME/CFS. Stark COI have been exposed by the commentaries including the PACE authors themselves who hold a double role as advisers to the UK Government Department of Work and Pensions (DWP), a sponsor of PACE, while at the same time working as advisers to large insurance companies who have gone on record about the potential financial losses from ME/CFS being deemed a long-term physical illness. In a further twist to the debate, undeclared COI of Petrie and Weinman (2017) were alleged (Lubet, 2017). Professors Weinman and Petrie adamantly deny that their work as advisers to Atlantis Healthcare represents a COI.

After the online publication of several critical Commentaries, Professors White, Sharpe, Chalder and 16 co-authors were offered a further opportunity to respond to their critics in the round but they chose not to do so.

After peer review, authors were invited to revise their manuscripts in response to reviewer feedback and many made multiple drafts. The outcome is a set of robust papers that should stand the test of time and offer significant new light on what went wrong with the PACE Trial that has been of such high significance for the nature of treatment protocols. It is disappointing that what has been the more dominant other side refused to participate.

Unfortunately, across the pro-PACE group of authors there was a consistent pattern of resistance to the debate. After receiving critical reviews, the pro-PACE authors chose to make only cosmetic changes or not to revise their manuscripts in any way whatsoever. They appeared unwilling to enter into the spirit of scientific debate. They acted with a sense of entitlement not to have to respond to criticism. Two pro-PACE authors even showed disdain for ME/CFS patients, stating: We have no wish to get into debates with patients. In another instance, three pro-PACE authors attempted to subvert the journal’s policy on COI by recommending reviewers who were strongly conflicted, forcing rejection of their paper.

The dearth of pro-PACE manuscripts to start off with (five submissions), the poor quality, the intransigence of authors to revise and the unavoidable rejection of three pro-PACE manuscripts led to an imbalance in papers between the two sides. However, this editor was loathe to compromise standards by publishing unsound pieces in spite of the pressure to go ahead and publish from people who should know better.

We are proud that this issue marks a special contribution by the Journal of Health Psychology to the literature concerning interventions to manage adaptation to chronic health problems. The PACE Trial debate reveals deeply embedded differences between critics and investigators. It also reveals an unwillingness of the co-principal investigators of the PACE trial to engage in discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5 million) on what is a textbook example of a poorly done trial.

ME/CFS research has been poorly served by the PACE Trial and a fresh new approach to treatment is clearly warranted. On the basis of this Special Issue, readers can make up their own minds about the scientific merits and demerits of the PACE Trial. It is to be hoped that the debate will provide a more rational basis for evidence-based improvements to the care pathway for hundreds of thousands of patients.

References

Geraghty, KJ (2016‘PACE-Gate’: When clinical trial evidence meets open data access. Journal of Health Psychology 22(9): 11061112Google ScholarSAGE JournalsISI
Lubet, S (2017Defense of the PACE trial is based on argumentation fallacies. Journal of Health Psychology 22(9): 12011205Google ScholarSAGE JournalsISI
Petrie, K, Weinman, J (2017The PACE trial: It’s time to broaden perceptions and move on. Journal of Health Psychology 22(9): 11981200Google ScholarSAGE JournalsISI
White, PD, Chalder, T, Sharpe, M. (2017Response to the editorial by Dr Geraghty. Journal of Health Psychology 22(9): 11131117Google ScholarSAGE JournalsISI

The Editorial has been abridged and the photograph of Dr. Keith Geraghty added.

Endorsements

Warm thanks to the authors of the following endorsements:

‘In A General Theory of Behaviour, David Marks embarks on the rare journey of creating a central theory of human behaviour, the things that underpin how we think, what we do, how we affiliate with others, and who we become..  Marks brings exceptional insights and a driving logic to bear to navigate through many fragmented theories of behaviour that are by their nature partial and limited.  It is not that these more fragmented theories are not often important, but that we need the grander theory to hold disparate ideas together.  Marks does so convincingly and in a way that is testable, refutable, and often even entertaining.  He demands that the reader think, question, and grasp a broad framework, and doing so will require the kind of thought that our internet-based, 140 character thinking has been reversing.  His ideas are truly worth the effort to sit back with a cup of coffee, and if necessary even a scotch, and think through, ponder, go back over, and incorporate into our appreciation of the eternal question of “what drives human behaviour.”  In A General Theory of Behaviour Marks has made a true contribution to psychology that comes from his careful listening, watching, and thinking over a decades-long career. It is his major contribution and one everyone interested in grasping the essence of human behaviour should tackle.’

Stevan Hobfoll, Rush University Medical Centre

“The field of psychology has many theories, but no General Theory. The unifying theory David Marks presents, along with the 20 principles, provide rich soil for further testing and opens up exciting avenues for psychology.”

Scott Barry Kaufman, Scientific Director, University of Pennsylvania

This inspiring book applies the seemingly simple biological concept of homeostasis to human behaviour.  There is beautiful historic detail about key researchers, whilst considering modern issues such as stress, lack of sleep and addiction. A compelling read, which feels like an engaging lecture, by a passionate and considered speaker.

Janine Crosbie, Psychology Lecturer, University of Salford,

In ‘A General Theory of Behaviour, David Marks has applied scientifically established theory to conceptualize disparate areas of Psychology in a manner that both unifies and brings greater insight, establishing this book as a milestone text of the 21st century.

Dr David A Holmes, Senior Lecturer in Psychology, Founder of the Forensic Research Group, Manchester Metropolitan University

Book cover small

Post-Traumatic Growth

Post-Traumatic Growth 

Experiences of life disruption, threat, distress, or adversity can lead to positively evaluated “growth” (Tedeschi and Calhoun, 1995). It has been observed for centuries that benefit finding and posttraumatic growth (PTG) can follow the occurrence of traumatic events including accidents, warfare, death of a loved one, and cancer diagnosis and treatment (Stanton, 2010).

Benefit finding and growth represent a fundamental restorative principle of homeostasis that is continually active towards the achievement of stability, equilibrium and well-being. Adaptation to any life-threatening illness, such as cancer, is facilitated by homeostasis systems that include the drive to find meaning, exert mastery or control over the experience, and bolster self-esteem. Growth and benefit-finding are frequently reported by cancer survivors as they gain awareness of their illness, its treatment and prognosis.

Measurement of PTG

The theoretical model of PTG proposed by Tedeschi and Calhoun suggests growth occurs in different ways.  Developing new relationships, finding new appreciation for life, new meanings in life, discovering personal strength, experiencing spiritual change, and realizing new opportunities are all possibilities. The experiences of benefit finding and growth are undeniable. The methods and measurements used for their study, however, raise more questions than answers.

Among cancer populations, reported prevalence rates of perceived PTG range from 53 to 90% and vary according to the type of cancer, time since diagnosis, heterogeneity and ethnicity of the sample, choice of measurement, and many personal factors (Coroiu et al., 2016). Posttraumatic growth is measured using scales such as “The Posttraumatic Growth Inventory” (PTGI), a 21-item measure of positive change following a traumatic or stressful event (Tedeschi and Calhoun, 1996). Respondents rate the degree to which positive change had occurred in their life “as a result of having cancer.” A total PTGI score and five subscale scores (New Possibilities, Relating to Others, Personal Strength, Spiritual Change, and Appreciation of Life) are calculated.

What the Critics Say

Critics have been less than enthusiastic about measuring PGI in this manner. James Coyne and Howard Tennen (2010) argue that: “Every PTG scale asks participants to rate how much they have changed on each scale item as the result of the crisis they faced. Thus, a respondent must: (a) evaluate her/his current standing on the dimension described in the item, e.g., a sense of closeness to others; (b) recall her/his previous standing on the same dimension; (c) compare the current and previous standings; (d) assess the degree of change; and (e) determine how much of that change can be attributed to the stressful encounter. Psychological science, which purportedly guides positive psychology, tells us that people cannot accurately generate or manipulate the information required to faithfully report trauma- or stress-related growth (or to report benefits) that results from threatening encounters…The psychological literature demonstrates consistently that people are unable to recollect personal change accurately” (Coyne and Tennen, 2010, p. 23).

The five steps a-e certainly are a tall order, and it seems highly doubtful that anybody could achieve them with any accuracy. It seems naïve to analyse numbers that research participants place on scales from the PTGI as though they are valid indices of ‘post-traumatic growth’ when no attempt is made to validate these measures.  In spite of these criticisms, many studies have been conducted using the PTGI scale.

Quack Science 

Quite rightly, Coyne and Tennen (2010) have damned the flawed methods and measures concerning PTG: “We are at a loss to explain why positive psychology investigators continue to endorse the flawed conceptualization and measurement of personal growth following adversity. Despite Peterson’s …warning that the credibility of positive psychology’s claim to science demands close attention to the evidence, post-traumatic growth—a construct that has now generated hundreds of articles—continues to be studied with flawed methods and a disregard for the evidence generated by psychological science. It is this same pattern of disregard that has encouraged extravagant claims regarding the health benefits of positive psychological states among individuals living with cancer” (p. 24).

As long as psychologists use shoddy methods, invalid measures and draw quack conclusions, they will not be taken seriously by outsiders.

Based on a section of: David F Marks et al. (2018) Health Psychology. Theory, Research & Practice (5th ed.) SAGE Publications Ltd.

The PACE Trial: A Catalogue of Errors

What was the PACE Trial?

Rarely in the history of clinical medicine have doctors and patients been placed so bitterly at loggerheads. The dispute had been a long time coming. Thirty years ago, a few psychiatrists and psychologists offered a hypothesis based on a Psychological Theory in which ME/CFS is constructed as a psychosocial illness. According to their theory, ME/CFS patients have “dysfunctional beliefs” that their symptoms are caused by an organic disease. The ‘Dysfunctional Belief Theory’ (DBT) assumes that no underlying pathology is causing the symptoms; patients are being ‘hypervigilant to normal bodily sensations‘ (Wessely et al., 1989; Wessely et al., 1991).

The Psychological Theory assumes that the physical symptoms of ME/CFS are the result of ‘deconditioning’ or ‘dysregulation’ caused by sedentary behaviour, accompanied by disrupted sleep cycles and stress. Counteracting deconditioning involves normalising sleep cycles, reducing anxiety levels and increasing physical exertion. To put it bluntly, the DBT asserts that ME/CFS is ‘all in the mind’.  Small wonder that patient groups have been expressing anger and resentment in their droves.

Top-Down Research

‘Top-down research’ uses a hierarchy of personnel, duties and skill-sets. The person at the top sets the agenda and the underlings do the work. The structure is a bit like the social hierarchy of ancient Egypt. Unless carefully managed, this top-down approach risks creating a self-fulfilling prophecy from confirmation biases at multiple levels. At the top of the research pyramid sits the ‘Pharaoh’, Regius Professor Sir Simon Wessely KB, MA, BM BCh, MSc, MD, FRCP, FRCPsych, F Med Sci, FKC, Knight of the Realm, President of the Royal College of Medicine, and originator of the DBT.  The principal investigators (PIs) for the PACE Trial, Professors White, Chalder and Sharpe, are themselves advocates of the DBT.  The PIs all have or had connections both to the Department of Work and Pensions and to insurance companies. The objective of the PACE Trial was to demonstrate that two treatments based on the DBT, cognitive behavioural therapy (CBT) and graded exercise therapy (GET), help ME/CFS patients to recover. There was zero chance the PACE researchers would fail to obtain the results they wanted. 

Groupthink, Conflicts and Manipulation

The PACE Trial team were operating within a closed system or groupthink in which they ‘know’ their theory is correct. With every twist and turn, no matter what the actual data show, the investigators are able to confirm their theory. The process is well-known in Psychology. It is a self-indulgent processes of subjective validation and confirmation bias.  Groupthink occurs when a group makes faulty decisions because group pressures lead to a deterioration of “mental efficiency, reality testing, and moral judgment” (Janis, 1972). Given this context, we can see reasons to question the investigators’ impartiality with many potential conflicts of interest (Lubet, 2017). Furthermore, critical analysis suggests that the PACE investigators involved themselves in manipulating protocols midway through the trial, selecting confirming data and omitting disconfirming data, and publishing biased reports of findings which created a catalogue of errors.

‘Travesty of Science’

The PACE Trial has been termed a ‘travesty of science’ while sufferers of ME/CFS continue to be offered unhelpful or harmful treatments and are basically being told to ‘pull themselves together’. One commentator has asserted that the situation for ME patients in the UK is: The 3 Ts – Travesty of Science; Tragedy for Patients and Tantamount to Fraud” (Professor Malcolm Hooper, quoted by Williams, 2017). Serious errors in the design, the protocol and procedures of the PACE Trial are evident. The catalogue of errors is summarised below. The PACE Trial was loaded towards finding significant treatment effects.

A Catalogue of Errors

The claimed benefits of GET and CBT for patient recovery are entirely spurious. The explanation lies in a sequence of serious errors in the design, the changed protocol and procedures of the PACE Trial. The investigators neglected or bypassed accepted scientific procedures for a RCT, as follows:

Error Category of error Description of error
1Ethical issue: Applying for ethical approval and funding for a long-term trial when the PIs knew already knew CBT effects on ME/CFS were short-lived. On 3rd November 2000, Sharpe confirmed: “There is a tendency for the difference between those receiving CBT and those receiving the comparison treatment to diminish with time due to a tendency to relapse in the former” (www.cfs.inform/dk). Wessely stated in 2001 that CBT is “not remotely curative” and that: “These interventions are not the answer to CFS” (Editorial: JAMA 19th September 2001:286:11) (Williams, 2016).
2Ethical issue: Failure to declare conflicts of interest to Joint Trial Steering Committee.Undeclared conflicts of interest by the three PIs in the Minutes of the Joint Trial Steering Committee and Data Monitoring Committee held on 27th September 2004.
3Ethical issue: Failure to obtain fully informed consent after non-disclosure of conflicts of interest.Failing to declare their vested financial interests to PACE participants, in particular, that they worked for the PHI industry, advising claims handlers that no payments should be made until applicants had undergone CBT and GET.
4Use of their own discredited “Oxford” criteria for entry to the trial.Patients with ME would have been screened out of the PACE Trial even though ME/CFS has been classified by the WHO as a neurological disease since 1969 (ICD-10 G93.3).
5Inadequate outcome measures.Using only subjective outcome measures.The original protocol included the collection of actigraphy data as an objective outcome measure. However, after the Trial started, the decision was taken that no post-intervention actigraphy data should be obtained.
6Changing the primary outcomes of the trial after receiving the raw data. Altering outcome measures mid-trial in a manner which gave improved outcomes.
7Changing entry criteria midway through the trial. Altering the inclusion criteria for trial entry after the main outcome measures were lowered so that some participants (13%) met recovery criteria at the trial entry point.
8The statistical analysis plan was published two years after selective results had been published. The Re-definition of “recovery” was not specified in the statistical analysis plan.
9Inadequate control Sending participants newsletters promoting one treatment arm over another, thus contaminating the trial.
10Inadequate controlLack of comparable placebo/control groups with inexperienced occupational therapists providing a control treatment and experienced therapists provided CBT.
11Inadequate controlRepeatedly informing participants in the GET and CBT groups that the therapies could help them get better.
12Inadequate control Giving patients in the CBT and GET arms having more sessions than in the control group.
13Inadequate controlAllowing therapists from different arms to communicate with each other about how patients were doing.

14

Lack of transparency

Blocking release of the raw data for five years preventing independent analysis by external experts.

Cover-Up

Blocking release of the raw data for five years and preventing independent analysis by external experts was tantamount to a cover-up of the true findings. An editorial by Keith Geraghty (2016) was entitled ‘PACE-Gate’. ME/CFS patient associations were rightly suspicious of the recovery claims concerning the GET arm of the trial because of their own experiences of intense fatigue after ordinary levels of activity which were inconsistent with the recovery claims of the PACE Trial reports. For many sufferers, even moderate exercise results in long ‘wipe-outs’ in which they are almost immobilized by muscle weakness and joint pain. In the US, post-exertional relapse has been recognized as the defining criterion of the illness by the Centers for Disease Control, the National Institutes of Health and the Institute of Medicine. For the PACE investigators, however, the announced recovery results validated their conviction that psychotherapy and exercise provided the key to reversing ME/CFS.

Alem Matthees Obtains Data Release

When Alem Matthees, a ME/CFS patient, sought the original data under the Freedom of Information Act and a British Freedom of Information tribunal ordered the PACE team to disclose their raw data, some of the data were re-analysed according to the original protocols. The legal costs of the tribunal at which QMUL were forced to release the data, against their strenuous objections, was over £245,000. The re-analysis of the PACE Trial data revealed that the so-called “recovery” under CBT and GET all but disappeared (Carolyn Wilshire, Tom Kindlon, Alem Matthees and Simon McGrath, 2016). The recovery rate for CBT fell to seven percent and the rate for GET fell to four percent, which were statistically indistinguishable from the three percent rate for the untreated controls. Graded exercise and CBT are still being routinely prescribed for ME/CFS in the UK despite patient reports that the treatments can cause intolerable pain and relapse. The analysis of the PACE Trial by independent critics has revealed a catalogue of errors and provides an object lesson in how not to conduct a scientific trial. The trial can be useful to instructors in research design and methodology for that purpose.

Following the re-analyses of the PACE Trial, the DBT is dead in the water. There is an urgent need for new theoretical approaches and scientifically-based treatments for ME/CFS patients. Meanwhile, there is repair work to be done to rebuild patient trust in the medical profession after this misplaced attempt to apply the Psychological Theory to the unexplained syndrome of ME/CFS. The envelope theory of Jason et al. (2009) proposes that people with ME/CFS need to balance their perceived and expended energy levels and provides one way forward, pending further research.

Ultimately, patients, doctors and psychologists are waiting for an organic account of ME/CFS competent to explain the symptoms and to open the door to effective treatments. Patients have a right to nothing less.

An extract from: David F Marks et al. (2018) Health Psychology. Theory, Research & Practice (5th ed.) SAGE Publications Ltd.