By David Tuller, DrPH
I have sent the following letter to Dr Fiona Godlee, editorial director of BMJ, about Archives of Disease in Childhood’s egregious decision to re-publish Bristol University’s Lightning Process trial with the original findings intact. Given the Bristol team’s flagrant methodological violations, the journal should have retracted the paper.
Failing that, Archives should have required the investigators to re-publish the paper with the initial primary outcome–school attendance at six months, which generated null results–as the final primary outcome. Dr Godlee was well aware of the issues involved, so she presumably endorsed the journal’s actions. The documented facts suggest that BMJ’s ethical compass is broken and that editors are more concerned about possible reputational damage than about the integrity of the medical literature or the health and well-being of children. That is presumably why dozens of scientists, clinicians and other experts from top academic institutions were so eager to sign this letter.
**********
Dear Dr Godlee—
We are writing about the correction appended last month [1] to the pediatric study of the Lightning Process conducted by investigators from the University of Bristol and published by Archives of Disease in Childhood in September, 2017. The study appeared under the following title: “Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.” [2]
As Virology Blog documented shortly after publication [3], the investigators recruited more than half the sample before trial registration as part of a feasibility study, swapped primary and secondary outcomes after gathering data from these early participants, and did not disclose these salient details in the paper. With the recent correction and an accompanying editor’s note, Archives of Disease in Childhood has acknowledged the validity of Virology Blog’s criticisms. Yet the journal has allowed the investigators to reassert their main conclusion–that the Lightning Process is “effective” in treating pediatric illness. This decision is untenable.
The Lightning Process is a commercial program combining life-coaching, neuro-linguistic programming and positive affirmations. Participants are taught that they can overcome illness by controlling and changing their thought patterns. Lightning Process practitioners have declared that they can successfully treat multiple sclerosis, eating disorders and other serious conditions. Government regulators have admonished practitioners for making misleading claims.
Beyond concerns about the Lightning Process itself, the Bristol study was an open-label trial with self-reported outcomes—a combination of design features that can lead to significant bias. Furthermore, in violating core methodological and ethical principles of scientific inquiry, the investigators also breached BMJ’s own strict policy against publishing any trials in which participants have been recruited before registration. Since all major medical journals adopted this policy in 2005, experienced investigators, including members of the Bristol team, should have been well aware of it.
BMJ has been a leader in the movement to require prospective registration as a condition for trials to be considered for publication. In 2013, in testimony before the House of Common’s Science and Technology Committee, you touted BMJ’s success in implementing a zero-tolerance approach to such trials. “As far as we are aware, in the last two years we have not published any trial that has not been prospectively registered,” you stated—a claim you could not accurately repeat today. [4] A 2015 editorial in The BMJ called the prospective registration policy “the single most valuable tool we have to ensure unbiased reporting of research studies.” [5]
Given BMJ’s longstanding position that prospective registration is essential for safeguarding the integrity of the medical literature, it is unclear why you are now willing to exempt the Lightning Process study from this requirement. The editor’s note posted with the correction declared that lack of prospective registration was not grounds for retraction. [6] No explanation or justification was provided for this determination, which appears to be incompatible with the zero-tolerance approach you advocated in your parliamentary testimony.
As you certainly know, a key goal of prospective registration is to prevent selective outcome reporting. Yet selective outcome reporting is exactly what occurred in the Lightning Process study when the investigators swapped primary and secondary outcomes mid-way through. In the published paper, the investigators reported positive results for the revised primary outcome of self-reported physical function at six months, which had initially been designated a secondary outcome. In contrast, they reported null results for the original primary outcome of school attendance at six months, which by the end had been demoted to a secondary outcome.
The swap thus ensured that the investigators were able to report positive rather than null results for their official primary outcome. Not surprisingly, this change had a major impact on how the information was presented in Archives of Disease in Childhood and interpreted by news organizations. The positive findings for the primary outcome that was selected after more than half the participants had provided data were prominently highlighted in the published paper. These findings received widespread media attention [7] and have recently been cited in a systematic review as evidence that the intervention is “effective.” [8] The null findings for the original primary outcome were ignored.
The editor’s note explains that the journal examined the outcome-swapping issue by “seeking assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase.” This statement is perplexing. Individuals subject to potential bias are not generally considered impartial and authoritative arbiters of whether this potential bias has influenced their decision-making. Study design is supposed to seek to minimize bias precisely because humans tend to be blind to their own biases. Reputable science in high-impact journals should not have to rely on investigators’ “assurance” that they have resisted the natural temptation to let their perceived interests guide their selection of primary outcomes.
Moreover, in relation to any assurances provided by the Bristol investigators, it is worth remembering that they withheld important information about trial registration and outcome-swapping from their public version of events. Archives of Disease in Childhood would not have published the paper in the first place except for two major failures: 1) The investigators’ failure to provide an accurate account of how they conducted the trial; and 2) The journal’s failure to detect disqualifying flaws, despite its obligation to subject the paper to rigorous peer review and editorial oversight.
Archives of Disease in Childhood has now re-published positive primary results generated by outcome-swapping in a study that did not meet a strict publication requirement specifically intended to prevent outcome-swapping and other kinds of selective outcome reporting. In doing so, the journal has rewarded the Bristol investigators for their lack of candor and their methodological missteps and has contradicted BMJ’s and your own past statements about the critical importance of prospective registration.
In this case, BMJ’s actions are scientifically and ethically indefensible. They are also potentially harmful to the health and well-being of children. Thank you for your prompt attention to this troubling matter.
Best–
Dharam V. Ablashi, DVM, MS, Dip Bact
Scientific Director
HHV-6 Foundation
Santa Barbara, California, USA
Former Senior Investigator
National Cancer Institute
National Institutes of Health
Bethesda, Maryland, USA
Michael Allen, PhD
Clinical Psychologist (retired)
San Francisco, California, USA
James N. Baraniuk, MD
Professor of Medicine
Georgetown University
Washington, DC, USA
Lisa F. Barcellos, MPH, PhD
Professor of Epidemiology
School of Public Health
California Institute for Quantitative Biosciences
University of California, Berkeley
Berkeley, California, USA
Lucinda Bateman, MD
Medical Director
Bateman Horne Center
Salt Lake City, Utah, USA
Alison C. Bested, MD, FRCPC
Clinical Director
Institute for Neuro-Immune Medicine
Associate Professor
Nova Southeastern University
Fort Lauderdale, Florida, USA
Charlotte Blease, PhD
Fulbright and Marie Curie Research Fellow
General Medicine and Primary Care
Beth Israel Deaconess Medical Center
Harvard Medical School
Boston, Massachusetts, USA
Molly Brown, PhD
Assistant Professor
Department of Psychology
DePaul University
Chicago, Illinois, USA
Robin Callender Smith, PhD
Professor of Media Law
Centre for Commercial Law Studies
Queen Mary University of London
Barrister and Information Rights Judge
London, England, UK
Janet L Dafoe, PhD
Child Psychologist in Private Practice
Palo Alto, California, USA
Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Stanford University
Stanford, California, USA
Simon Duffy, PhD, FRSA
Director
Centre for Welfare Reform
Sheffield, England, UK
Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London
London, England, UK
Valerie Eliot Smith
Barrister and Visiting Scholar
Centre for Commercial Law Studies
Queen Mary University of London
London, England, UK
Margaret C Fernald, PhD
Clinical Child Psychologist
Clinical Associate of Psychology
University of Maine
Orono, Maine, USA
Kenneth J. Friedman, PhD
Associate Professor of Physiology and Pharmacology (retired)
New Jersey Medical School
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, USA
Robert F. Garry, PhD
Professor of Microbiology and Immunology
Tulane University School of Medicine
New Orleans, Louisiana, USA
Claudia Gillberg, PhD
Fellow, Centre for Welfare Reform
Sheffield, England, UK
Senior Research Associate
National Centre for Lifelong Learning
Jonkoping University
Jonkoping, Sweden
Rebecca Goldin, PhD
Professor of Mathematics
George Mason University
Fairfax, Virginia, USA
Alan Gurwitt, MD
Psychiatrist in Private Practice (retired)
Associate Clinical Professor
Yale Child Study Center (retired)
New Haven, Connecticut, USA
Associate Clinical Professor
University of Connecticut Dept of Psychiatry (retired)
Storrs, Connecticut, USA
Lecturer, Harvard Medical School (retired)
Boston, Massachusetts, USA
Geoffrey Hallmann, LLB, DipLegPrac, DipFinPrac
Specialist in Disability and Compensation Law (retired)
Lismore, New South Wales, Australia
Brian M. Hughes, PhD, FPsSI
Professor of Psychology
National University of Ireland, Galway
Galway, Ireland
Leonard A. Jason, PhD
Professor of Psychology
DePaul University
Chicago, Illinois, USA
Maureen Hanson, PhD
Liberty Hyde Bailey Professor
Department of Molecular Biology and Genetics
Cornell University
Ithaca, New York, USA
Keith Kahn-Harris, PhD
Associate Lecturer in Sociology
Birkbeck, University of London
London, England, UK
Jon D. Kaiser, M.D.
Clinical Faculty
Department of Medicine
University of California, San Francisco
San Francisco, California, USA
Nancy Klimas MD
Director, Institute for Neuro-Immune Medicine
Nova Southeastern University
Director, Miami VA Medical Center GWI and CFS/ME Program
Miami, Florida, USA
Eliana M. Lacerda, MD, MSc, PhD
Clinical Assistant Professor
International Centre for Evidence in Disability
Faculty of Infectious and Tropical Diseases
London School of Hygiene & Tropical Medicine
London, England, UK
Bruce Levin, PhD
Professor of Biostatistics
Columbia University
New York, New York, USA
Rogier Louwen, PhD
Assistant Professor
Department of Medical Microbiology and Infectious Diseases
Erasmus University Medical Center
Rotterdam, The Netherlands
Steven Lubet, JD
Williams Memorial Professor of Law
Northwestern University Pritzker School of Law
Chicago, Illinois, USA
Marlon Maus, MD, DrPH, FACS
Director, DrPH Program
School of Public Health
University of California, Berkeley
Berkeley, California, USA
Patrick E. McKnight, PhD
Professor of Psychology
George Mason University
Fairfax, Virginia, USA
Heidi Nicholl, PhD
Chief Executive Officer
Emerge Australia
Melbourne, Victoria, Australia
Steve Olson, MD
Family Physician
Large Medical Group Executive and Regional Physician Director
Oakland, California, USA
Elisa Oltra, PhD
Professor of Molecular and Cellular Biology
Catholic University of Valencia School of Medicine
Valencia, Spain
Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
Columbia University
New York, New York, USA
Arthur L. Reingold, MD
Professor of Epidemiology
University of California, Berkeley
Berkeley, California, USA
Ola Didrik Saugstad, MD, PhD
Professor Emeritus
Division of Paediatric and Adolescent Medicine
University of Oslo
Oslo, Norway
Adjunct Professor of Pediatrics
Feinberg School of Medicine
Northwestern University
Chicago, Illinois, USA
David Scales MPhil, MD, PhD
Assistant Professor of Medicine
Division of Hospital Medicine
Weill Cornell Medicine
New York, New York, USA
Michael Scott, PhD
Clinician and Researcher
Psychological Therapies Unit
Liverpool, England, UK
Philip B. Stark, PhD
Professor of Statistics
University of California, Berkeley
Berkeley, California, USA
Eleanor Stein, MD, FRCP(C)
Psychiatrist in Private Practice
Assistant Clinical Professor
University of Calgary
Calgary, Alberta, Canada
Leonie Sugarman, PhD
Emeritus Associate Professor of Applied Psychology
University of Cumbria
Carlisle, England, UK
John Swartzberg, MD
Clinical Professor Emeritus
School of Public Health
University of California, Berkeley
Berkeley, California, USA
Ronald G. Tompkins, MD, ScD
Summer M Redstone Professor of Surgery
Harvard Medical School
Boston, Massachusetts, USA
Samuel Tucker, MD
Assistant Clinical Professor of Psychiatry (retired)
University of California, San Francisco
San Francisco, California, USA
David Tuller, DrPH
Senior Fellow in Public Health and Journalism
Center for Global Public Health
University of California, Berkeley
Berkeley, California, USA
Rosamund Vallings, MNZM, MBBS
General Practitioner
Auckland, New Zealand
Linda van Campen, MD
Cardiologist
Stichting Cardiozorg
Hoofddorp, The Netherlands
Mark Vink, MD
Family Physician
Soerabaja Research Center
Amsterdam, The Netherlands
Frans Visser, MD
Cardiologist
Stichting Cardiozorg
Hoofddorp, The Netherlands
Tony Ward, MA (Hons), PhD, DipClinPsyc
Registered Clinical Psychologist
Professor of Clinical Psychology
School of Psychology
Victoria University of Wellington
Wellington, New Zealand
Adjunct Professor, School of Psychology
University of Birmingham
Birmingham, England, UK
Adjunct Professor, School of Psychology
University of Kent
Canterbury, England, UK
John Whiting, MD
Specialist Physician in Private Practice
Brisbane, Queensland, Australia
Carolyn Wilshire, PhD
Senior Lecturer
School of Psychology
Victoria University of Wellington
Wellington, New Zealand
**********
[1] Crawley E, Gaunt D, Garfield K, et al. Notice of correction and clarification: Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. Archives of Disease in Childhood; 2019. Accessed at: https://adc.bmj.com/content/early/2019/08/17/archdischild-2017-313375corr1
[2] Crawley E, Gaunt D, Garfield K, et al. Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. Archives of Disease in Childhood; 2018; 103:155-164
[3] Tuller D. Trial by error: the SMILE trial’s undisclosed outcome-swapping. Virology Blog; Dec 13, 2017. Accessed at: https://www.virology.ws/2017/12/13/trial-by-error-the-smile-trials-undisclosed-outcomes/
[4] Clinical trials: Hearings before the Science and Technology Committee, House of Commons; March 13, 2003. (Testimony of Fiona Godlee) Accessed at: https://publications.parliament.uk/pa/cm201213/cmselect/cmsctech/uc1054-i/uc105401.htm
[5] Weber W, Merino J, Loder E. Editorial: trial registration 10 years on. BMJ; 2015; 351. Accessed at: https://www.bmj.com/content/351/bmj.h3572
[6] Brown N. Editor’s note on correction to Crawley et al (2018). Archives of Disease in Childhood; 2019. Accessed at: https://adc.bmj.com/content/early/2019/08/17/archdischild-2017-313375ednote
[7] Bosely, S. Controversial Lightning Process ‘helps children with chronic fatigue syndrome.’ The Guardian; September 20, 2017. Accessed at: https://www.theguardian.com/society/2017/sep/20/controversial-lightning-process-helps-children-with-chronic-fatigue-syndrome-me
[8] Gregorowski A, Simpson J, Segal T. Child and adolescent chronic fatigue syndrome/myalgic encephalomyelitis; where are we now? Current Opinion in Pediatrics; 2019; 31: 462-46.
Comments
15 responses to “An Open Letter to Dr Godlee about BMJ’s Ethically Bankrupt Actions”
These ethical and methodological malpractices worryingly seem to typify the work of the work of the predominantly British researchers in the so called bio psychosocial approaches to ME/CFS.
It is perhaps understandable that a group of researchers get carried away by their collective enthusiasm for a methodological approach that superficially seems to confirm their untested theoretical underpinning and their ideological biases. However it is more profoundly worrying that the very systems designed to combat such biases, ethics committees and journal policies and peer reviewing systems, are at best failing or at worst being deliberately subverted to promote eminence based interventions.
I hope such malpractices are confined to this narrow field of research, though the on going collusion of British universities and such as the BMJ, even once they have been forced to admit at least partially the validity of criticisms, does not inspire confidence.
Thank you to all the academics who signed this further letter requesting the retraction of this paper which is effectively endorsing the potential for iatrogenic child abuse.
A big thank you from Norway. Lightning Process is a big problem for ME-patients here.
Read more: https://melivet.com/2018/10/17/about-the-recovery-network-norway-and-what-me-patients-are-up-against/
I missed the bit stating that LP was known to be an utter con from the get go. Still, if anyone wants to publish a study about a con, so be it. I’d argue that the peer review safeguard failed here. Again.
Now they can fund a study to show it works for cancer and diabetes and typhoid and Ebola, too.
They need to realize they are becoming a laughingstock, and every day it will get harder for them to do what they should have done from the beginning: distance themselves from bad science.
Where did truth, honesty and integrity go? It seems to me that there is a vast chasm here between the values that Godlee and the BMJ preach [https://www.bmj.com/company/who-we-are/values/] and what they actually do in practice.
With 55 signers from all around the world – Australia, Canada, Ireland, The Netherlands, New Zealand, Norway, Spain, Sweden, the UK and the USA – you’d think that the BMJ company might now be worried about their global reputation. But I suspect they are too arrogant for that.
This refusal to even play by their own rules smacks now of cronyism. I’m guessing there must be some friendships at risk for Godlee to continue to behave in this cavalier manner. After all Virology Blog has done an excellent job in both elucidating the flaws in BMJ published studies associated with ME as well as directly asking BMJ publications (and therefore Godlee herself) to account for their (her) motivation in not adhering to good scientific principles. If we cannot trust BMJ publications to publish within the constructs they place upon themselves and laud as being desirable then there is no reason to take any publication from the group as being reliable any more..and I, for one, won’t do so. Their whole raison d’etre is wiped out. This can’t be about science..this is about mukkers and the reputation of mukkers… I’m surprised Godlee is happy to fall on her sword, & make an utter fool of herself, instead of hanging Crawley et al out to dry. Godlee must like Crawley very much indeed!
It strikes me that using subjective outcomes for a “treatment” that teaches patients to say only positive things about LP or it won’t work is a one-way ticket to complete nonsense. This trial contains a huge problem in that the trial subjects will almost certainly not be able or willing to answer honestly due to the nature of LP. Did either the trial report or the BMJ acknowledge this?
Maybe in the long run we will see that the BMJ’s refusal to retract has simply hastened the end of the research publishing parasites. When research findings had to be typeset, printed, and mailed, the publishers played a vital role in spreading knowledge. Now they are mostly just polluting the scientific knowledge base with unreliable rubbish.
BMJ are actively harming people by promoting LP. When will they be held liable for the harm they have caused? Putting them out of business would be a good place to start.
Who peer reviews the peer reviewers? BMJ has failed in its obligations. Cochrane has failed. PLOS has failed. NICE has failed. The Lancet has failed. British medical science is having a sort of ethical Brexit of its own.
The system of medical publishing seems utterly broken in the face of psychology-based pseudoscience. It’s utterly bizarre to witness the profession tasked with matters of life and death regressing in this way, as if there were no consequences to lowering the bar and suspending all the normal rules and processes that make medical science credible.
Is the British Medical Association aware of putting their seal of approval on this pseudoscientific nonsense? Are there no concerns about patient safety and rigorous research anymore? Clearly not. Anything goes in this mad dash to the bottom.
The snake oil has transcended its bottle and taken the shape of a Freudian pipe dream. Ceci est définitivement une pipe.
Thank you again, David, for a letter so clear that many other eminent people are willing to put their names to it. Thank you to all who have signed it. It is so encouraging to know that David is not a lone voice, that others are willing to speak up about these damaging practices.
The subjects on whose self-reports the paper relies are children, not adults, who have been (unwillingly in some cases…Crawley says that many invited did not want to participate) subjected to a process of which the rules are:
You must always say you are cured, no matter how you actually feel.
The process won’t work if you tell anyone what it is.
(They’ve been told to lie, and not to tell anyone they’ve been told to lie.)
Then they are asked to ‘self-report’ on how the treatment has worked.
The BMJ sees no reason to question ‘positive results’ obtained in this way.
I think more should be made of the fact that Crawley has a history of switching outcomes, having done the same on PACE. I’m pretty sure it happened in a few others as well.
This is a bad enough justification once, but to have done it at least once more before, where it lead to massive changes in outcome, switching a null result to a dodgy positive one, especially one where the authors explicitly stated they did so because they preferred the better results and that they aligned with their expectations. “Assurances” given this prior behavior is quite frankly an insulting response, one that BMJ seems happy to accept.
It’s clearly a habit for her and her colleagues, one that BMJ and other medical journals are now in the process of normalizing, even encouraging, through arbitrary exemptions. This should be alarming to anyone who values integrity in scientific research. Of which there are dozens, dozens!
(BTW I am not seeing the latest posts on the http://virology.ws/mecfs/ page, stops in June)
This is an alert, and a question, to what I presume is a concerned audience.
A recent Twitter seems to me to be saying that parents who have been invited, or have offered, to participate in the Guideline consultation for paediatric ME/CFS are being selected on the basis of their willingness to go along with the prescription that children must have their wheelchairs/other aids taken away, and made to do things whether they feel like it or not. I’m not sure I have interpreted it correctly, but it said that if you refused to go along with this, you were not selected to be on the advisory group.
This fits with the apparently increasing relabelling ME, and severe ME in children with the psychiatric labels ‘Pervasive Refusal Syndrome’…Crawley is reported to do this with kids that don’t get better…and ‘Fabricated or Induced Illness’ (the mother is creating it by her care of the child)…used to justify the also increasing practice of taking children into care and putting them into psychiatric institutions, where they are treated along the lines indicated above.
Guys, we are not winning this one…..
That, and the recent ‘research’ paper which purports to support ‘pacing’ (GET renamed) are clearly designed to support implementing the BPS model of ME/CFS and keep it under the psychiatric remit in the ‘revised’ Guideline CG53.
The recent paper was a survey of the views of professionals working with ME patients, presumably in settings already committed to the BPS model. Their (unbiassed?) opinions somehow become evidence?
The goal of treatment/management, as set out in the current Guideline CG53, is to ‘increase activity’. Nothing about ‘helping patients recover’. We surely had the right to hope that etiology and the pathophysiology of the illness would become the basis of new treatment recommendations.
If that happened, and the IOM report description…this illness is not psychogenic, and it’s defining characteristic is that exertion of any kind can cause multisystem damage…were used as a starting point, then Ramsay and Acheson’s original insistence that complete rest from the inception give the best prognosis comes into its own, and ‘increasing activity’ would be recognised as medical abuse. But no.
It seems that this review is even worse than I predicted in my article
http://www.positivehealth.com/article/cfs-me/what-can-we-expect-from-the-current-review-of-nice-guideline-cg53
….they are going to reinforce their justifications for forcing people with ME to exert themselves, thereby driving patients…including or maybe especially…children…into more severe incapacity and pain, and, as in a recent well-publicised case, this will be enforced by threats of involuntary incarceration in psychiatric facilities, by removal of parental rights if necessary.
I always knew that revision of the Guideline was a false hope, but it seems that the determination to retain CBT/GET is becoming even more forceful. The latest call for papers (only those involved in a comparative trial, no individual accounts, case studies) will find further PACE-type efforts coming out of the woodwork.
The people behind these efforts cannot fail to know the damage and extreme levels of pain which they are causing to the children being subjected to such treatment….what is the DSM label for this kind of behaviour?
David, you really have your work cut out…maybe you should start employing a body-guard and someone to taste your food!
Rather than the people involved in this murky business being ‘mukkers’, I suspect this has more to do with the UK medical establishment doing what it frequently appears to do – ignoring, covering up and defending wrongdoing while attacking those who try to expose it. If it had just been some insignificant person doing this research or if it had come from a bog-standard university then perhaps we’d have seen a different outcome. My guess is that this part of the medical establishment particularly didn’t want to see 4 Russell Group professors from a Russell Group University stained by the retraction of such a well-publicized paper so, just in this case, they made an exception, putting individual and corporate reputations before the health and safety of highly vulnerable children.
The question then arises – why/how did these Russell Group professors find themselves in this position? Could they all have been ignorant of correct methodological and ethical practice? That doesn’t really wash given their job descriptions. Or could they have allowed their names to be added to a study they didn’t know enough about in order to notch up their research paper tally? Surely not. They seem to have claimed this was a genuine mistake but, if so, how exactly was that mistake made? Did BMJ and ADC interrogate them on that? I doubt it. In the interests of UK research integrity and of the reputation of UK research as a whole, I’d like to see the House of Common’s Science and Technology Committee cross examine them all on this.
My guess is that they are letting the paper stand, because it is really the toe in the door for a follow up paper on these lines:
‘Children claiming to be unable to attend school due to chronic illness were challenged by means of attending a course of sham treatment, that could at best be described as possibly acting as a placebo in suggestible people.
After completing the sham treatment, the children were required to fill out questionnaires on whether they found the treatment effective to any degree.
The resulting ‘surprise’ slight improvement with the sham treatment was not matched with any increase in school attendance.
Interpretation: Children claimed to have improved under a sham treatment that is incapable of curing a real physical illness, yet they did not return to school.
This supports a diagnosis of school phobia or pervasive refusal syndrome, where the children had no desire to return to school whether they felt better or not.
Secondarily: Evidence is accrued to support the hypothesis that ‘M.E.’ is a psychological phenomenon, which can be tricked into improving through belief in a sham treatment.’
I would guess that such a paper is well on the way to publication, with a big fanfare of ‘nyah nyahs’ from the ‘Science Media Centre’.