Last week, Virology Blog posted an open letter to the editors of Psychological Medicine. The letter called on them to retract the misleading findings that participants in the PACE trial for ME/CFS had “recovered” from cognitive behavior therapy and graded exercise therapy. More than 100 scientists, clinicians, other experts and patient organizations signed the letter.
Three days later, I received a response from Sir Robin Murray, the UK editor of Psychological Medicine. Here’s what he wrote:
Thank you for your letter and your continuing interest in the paper on the PACE Trial which Psychological Medicine published. I was interested to learn that Wilshire and colleagues have now published a reanalysis of the original data from the PACE Trial in the journal Fatigue: Biomedicine, Health & Behavior, a publication that I was not previously aware of. Presumably, interested parties will now be able to read this reanalysis and compare the scientific qualiity of the re-analysis with that of the original. My understanding is that this is the way that science advances.
This is an unacceptable response. Sir Robin Murray is misguided if he believes that science advances by allowing misleading claims based on manipulated data to stand in the literature. When researchers include participants who were already “recovered” on key indicators at baseline, the findings are by definition so flawed and nonsensical they must be retracted.
That the editors of Psychological Medicine do not grasp that it is impossible to be “disabled” and “recovered” simultaneously on an outcome measure is astonishing and deeply troubling. It is equally astonishing that the PACE authors now defend themselves, as noted in a New York Times opinion piece on Sunday, by arguing that this overlap doesn’t matter because there were also other recovery criteria.
In response to the comments from Psychological Medicine, we are reposting the open letter with 17 added individuals and 24 more organizations, for a total of 142 signatories altogether. These include two lawyers from Queen Mary University of London, the academic home of lead PACE investigator Peter White, along with other experts and ME/CFS patient groups from around the world.
Sir Robin Murray and Dr. Kenneth Kendler
Psychological Medicine
Cambridge University Press
University Printing House
Shaftesbury Road
Cambridge CB2 8BS
UK
Dear Sir Robin Murray and Dr. Kendler:
In 2013, Psychological Medicine published an article called “Recovery from chronic fatigue syndrome after treatments given in the PACE trial.”[1] In the paper, White et al. reported that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) each led to recovery in 22% of patients, compared with only 7% in a comparison group. The two treatments, they concluded, offered patients “the best chance of recovery.”
PACE was the largest clinical trial ever conducted for chronic fatigue syndrome (also known as myalgic encephalomyelitis, or ME/CFS), with the first results published in The Lancet in 2011.[2] It was an open-label study with subjective primary outcomes, a design that requires strict vigilance to prevent the possibility of bias. Yet PACE suffered from major flaws that have raised serious concerns about the validity, reliability and integrity of the findings.[3] Despite these flaws, White et al.’s claims of recovery in Psychological Medicine have greatly impacted treatment, research, and public attitudes towards ME/CFS.
According to the protocol for the PACE trial, participants needed to meet specific benchmarks on four different measures in order to be defined as having achieved “recovery.”[4] But in Psychological Medicine, White et al. significantly relaxed each of the four required outcomes, making “recovery” far easier to achieve. No PACE oversight committees appear to have approved the redefinition of recovery; at least, no such approvals were mentioned. White et al. did not publish the results they would have gotten using the original protocol approach, nor did they include sensitivity analyses, the standard statistical method for assessing the impact of such changes.
Patients, advocates and some scientists quickly pointed out these and other problems. In October of 2015, Virology Blog published an investigation of PACE, by David Tuller of the University of California, Berkeley, that confirmed the trial’s methodological lapses.[5] Since then, more than 12,000 patients and supporters have signed a petition calling for Psychological Medicine to retract the questionable recovery claims. Yet the journal has taken no steps to address the issues.
Last summer, Queen Mary University of London released anonymized PACE trial data under a tribunal order arising from a patient’s freedom-of-information request. In December, an independent research group used that newly released data to calculate the recovery results per the original methodology outlined in the protocol.[6] This reanalysis documented what was already clear: that the claims of recovery could not be taken at face value.
In the reanalysis, which appeared in the journal Fatigue: Biomedicine, Health & Behavior, Wilshire et al. reported that the PACE protocol’s definition of “recovery” yielded recovery rates of 7 % or less for all arms of the trial. Moreover, in contrast to the findings reported in Psychological Medicine, the PACE interventions offered no statistically significant benefits. In conclusion, noted Wilshire et al., “the claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments.”
In short, the PACE trial had null results for recovery, according to the protocol definition selected by the authors themselves. Besides the inflated recovery results reported in Psychological Medicine, the study suffered from a host of other problems, including the following:
*In a paradox, the revised recovery thresholds for physical function and fatigue–two of the four recovery measures–were so lax that patients could deteriorate during the trial and yet be counted as “recovered” on these outcomes. In fact, 13 % of participants met one or both of these recovery thresholds at baseline. White et al. did not disclose these salient facts in Psychological Medicine. We know of no other studies in the clinical trial literature in which recovery thresholds for an indicator actually represented worse health status than the entry thresholds for serious disability on the same indicator.
*During the trial, the authors published a newsletter for participants that included glowing testimonials from earlier participants about their positive outcomes in the trial.[7] An article in the same newsletter reported that a national clinical guidelines committee had already recommended CBT and GET as effective; the newsletter article did not mention adaptive pacing therapy, an intervention developed specifically for the PACE trial. The participant testimonials and the newsletter article could have biased the responses of an unknown number of the two hundred or more people still undergoing assessments—about a third of the total sample.
*The PACE protocol included a promise that the investigators would inform prospective participants of “any possible conflicts of interest.” Key PACE investigators have had longstanding relationships with major insurance companies, advising them on how to handle disability claims related to ME/CFS. However, the trial’s consent forms did not mention these self-evident conflicts of interest. It is irrelevant that insurance companies were not directly involved in the trial and insufficient that the investigators disclosed these links in their published research. Given this serious omission, the consent obtained from the 641 trial participants is of questionable legitimacy.
Such flaws are unacceptable in published research; they cannot be defended or explained away. The PACE investigators have repeatedly tried to address these concerns. Yet their efforts to date—in journal correspondence, news articles, blog posts, and most recently in their response to Wilshire et al. in Fatigue[8]—have been incomplete and unconvincing.
The PACE trial compounded these errors by using a case definition for the illness that required only one symptom–six months of disabling, unexplained fatigue. A 2015 report from the U.S. National Institutes of Health recommended abandoning this single-symptom approach for identifying patients.[9] The NIH report concluded that this broad case definition generated heterogeneous samples of people with a variety of fatiguing illnesses, and that using it to study ME/CFS could “impair progress and cause harm.”
PACE included sub-group analyses of two alternate and more specific case definitions, but these case definitions were modified in ways that could have impacted the results. Moreover, an unknown number of prospective participants might have met these alternate criteria but been excluded from the study by the initial screening.
To protect patients from ineffective and possibly harmful treatments, White et al.’s recovery claims cannot stand in the literature. Therefore, we are asking Psychological Medicine to retract the paper immediately. Patients and clinicians deserve and expect accurate and unbiased information on which to base their treatment decisions. We urge you to take action without further delay.
Sincerely,
Dharam V. Ablashi, DVM, MS, Dip Bact
Scientific Director
HHV-6 Foundation
Former Senior Investigator
National Cancer Institute
National Institutes of Health
Bethesda, Maryland, USA
James N. Baraniuk, MD
Professor, Department of Medicine
Georgetown University
Washington, D.C., 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 Associate Professor
Faculty of Medicine
University of British Columbia
Vancouver, British Columbia, Canada
Molly Brown, PhD
Assistant Professor
Department of Psychology
DePaul University
Chicago, Illinois, USA
John Chia, MD
Clinician and Researcher
EVMED Research
Lomita, California, USA
Todd E. Davenport, PT, DPT, MPH, OCS
Associate Professor
Department of Physical Therapy
University of the Pacific
Stockton, 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, UK
Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London
London, UK
Derek Enlander, MD
New York, New York, USA
Meredyth Evans, PhD
Clinical Psychologist and Researcher
Chicago, Illinois, 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
Keith Geraghty, PhD
Honorary Research Fellow
Division of Population Health, Health Services Research & Primary Care
School of Health Sciences
University of Manchester
Manchester, UK
Ian Gibson, PhD
Former Member of Parliament for Norwich North
Former Dean, School of Biological Sciences
University of East Anglia
Honorary Senior Lecturer and Associate Tutor
Norwich Medical School
University of East Anglia
Norwich, UK
Rebecca Goldin, PhD
Professor of Mathematics
George Mason University
Fairfax, Virginia, USA
Ellen Goudsmit, PhD, FBPsS
Health Psychologist (retired)
Former Visiting Research Fellow
University of East London
London, UK
Maureen Hanson, PhD
Liberty Hyde Bailey Professor
Department of Molecular Biology and Genetics
Cornell University
Ithaca, New York, USA
Malcolm Hooper, PhD
Emeritus Professor of Medicinal Chemistry
University of Sunderland
Sunderland, UK
Leonard A. Jason, PhD
Professor of Psychology
DePaul University
Chicago, Illinois, USA
Michael W. Kahn, MD
Assistant Professor of Psychiatry
Harvard Medical School
Boston, Massachusetts, USA
Jon D. Kaiser, MD
Clinical Faculty
Department of Medicine
University of California, San Francisco
San Francisco, California, USA
David L. Kaufman, MD
Medical Director
Open Medicine Institute
Mountain View, California, USA
Betsy Keller, PhD
Department of Exercise and Sports Sciences
Ithaca College
Ithaca, New York, 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
Andreas M. Kogelnik, MD, PhD
Director and Chief Executive Officer
Open Medicine Institute
Mountain View, California, USA
Eliana M. Lacerda, MD, MSc, PhD
Clinical Assistant Professor
Disability & Eye Health Group/Clinical Research Department
Faculty of Infectious and Tropical Diseases
London School of Hygiene & Tropical Medicine
London, UK
Charles W. Lapp, MD
Medical Director
Hunter-Hopkins Center
Charlotte, North Carolina, USA
Assistant Consulting Professor
Department of Community and Family Medicine
Duke University School of Medicine
Durham, North Carolina, USA
Bruce Levin, PhD
Professor of Biostatistics
Columbia University
New York, New York, USA
Alan R. Light, PhD
Professor of Anesthesiology
Professor of Neurobiology and Anatomy
University of Utah
Salt Lake City, Utah, USA
Vincent C. Lombardi, PhD
Director of Research
Nevada Center for Biomedical Research
Reno, Nevada, USA
Alex Lubet, PhD
Professor of Music
Head, Interdisciplinary Graduate Group in Disability Studies
Affiliate Faculty, Center for Bioethics
Affiliate Faculty, Center for Cognitive Sciences
University of Minnesota
Minneapolis, Minnesota, USA
Steven Lubet
Williams Memorial Professor of Law
Northwestern University Pritzker School of Law
Chicago, Illinois, USA
Sonya Marshall-Gradisnik, PhD
Professor of Immunology
Co-Director, National Centre for Neuroimmunology and Emerging Diseases
Griffith University
Queensland, Australia
Patrick E. McKnight, PhD
Professor of Psychology
George Mason University
Fairfax, Virginia, USA
Jose G. Montoya, MD, FACP, FIDSA
Professor of Medicine
Division of Infectious Diseases and Geographic Medicine
Stanford University School of Medicine
Stanford, California, USA
Zaher Nahle, PhD, MPA
Vice President for Research and Scientific Programs
Solve ME/CFS Initiative
Los Angeles, California, USA
Henrik Nielsen, MD
Specialist in Internal Medicine and Rheumatology
Copenhagen, Denmark
James M. Oleske, MD, MPH
François-Xavier Bagnoud Professor of Pediatrics
Senator of RBHS Research Centers, Bureaus, and Institutes
Director, Division of Pediatrics Allergy, Immunology & Infectious Diseases
Department of Pediatrics
Rutgers New Jersey Medical School
Newark, New Jersey, USA
Elisa Oltra, PhD
Professor of Molecular and Cellular Biology
Catholic University of Valencia School of Medicine
Valencia, Spain
Richard Podell, MD, MPH
Clinical Professor
Department of Family Medicine
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, USA
Nicole Porter, PhD
Psychologist in Private Practice
Rolling Ground, Wisconsin, USA
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
Anders Rosén, MD
Professor of Inflammation and Tumor Biology
Department of Clinical and Experimental Medicine
Division of Cell Biology
Linköping University
Linköping, Sweden
Peter C. Rowe, MD
Professor of Pediatrics
Johns Hopkins University School of Medicine
Baltimore, Maryland, USA
William Satariano, PhD
Professor of Epidemiology and Community Health
University of California, Berkeley
Berkeley, California, USA
Ola Didrik Saugstad, MD, PhD, FRCPE
Professor of Pediatrics
University of Oslo
Director and Department Head
Department of Pediatric Research
University of Oslo and Oslo University Hospital
Oslo, Norway
Charles Shepherd, MB, BS
Honorary Medical Adviser to the ME Association
Buckingham, UK
Christopher R. Snell, PhD
Scientific Director
WorkWell Foundation
Ripon, California, USA
Donald R. Staines, MBBS, MPH, FAFPHM, FAFOEM
Clinical Professor
Menzies Health Institute Queensland
Co-Director, National Centre for Neuroimmunology and Emerging Diseases
Griffith University
Queensland, Australia
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
Staci Stevens, MA
Founder, Exercise Physiologist
Workwell Foundation
Ripon, California, USA
Julian Stewart, MD, PhD
Professor of Pediatrics, Physiology and Medicine
Associate Chairman for Patient Oriented Research
Director, Center for Hypotension
New York Medical College
Hawthorne, NY, USA
Leonie Sugarman, PhD
Emeritus Associate Professor of Applied Psychology
University of Cumbria
Carlisle, 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
David Tuller, DrPH
Lecturer in Public Health and Journalism
University of California, Berkeley
Berkeley, California, USA
Rosemary A. Underhill, MB, BS, MRCOG, FRCSE
Physician and Independent Researcher
Palm Coast, Florida, USA
Rosamund Vallings, MNZM, MB, BS
General Practitioner
Auckland, New Zealand
Michael VanElzakker, PhD
Research Fellow, Psychiatric Neuroscience Division
Harvard Medical School & Massachusetts General Hospital
Instructor, Tufts University Psychology
Boston, Massachusetts, USA
Mark VanNess, PhD
Professor of Health, Exercise & Sports Sciences
University of the Pacific
Stockton, California, USA
Workwell Foundation
Ripon, California, USA
Mark Vink, MD
Family Physician
Soerabaja Research Center
Amsterdam, Netherlands
Frans Visser, MD
Cardiologist
Stichting Cardiozorg
Hoofddorp, 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, UK
Adjunct Professor, School of Psychology
University of Kent
Canterbury, UK
William Weir, FRCP
Infectious Disease Consultant
London, UK
John Whiting, MD
Specialist Physician
Private Practice
Brisbane, Australia
Carolyn Wilshire, PhD
Senior Lecturer
School of Psychology
Victoria University of Wellington
Wellington, New Zealand
Michael Zeineh, MD, PhD
Assistant Professor
Department of Radiology
Stanford University
Stanford, California, USA
Marcie Zinn, PhD
Research Consultant in Experimental Electrical Neuroimaging and Statistics
Center for Community Research
DePaul University
Chicago, Illinois, USA
Executive Director
Society for Neuroscience and Psychology in the Performing Arts
Dublin, California, USA
Mark Zinn, MM
Research Consultant in Experimental Electrophysiology
Center for Community Research
DePaul University
Chicago, Illinois, USA
New individuals added 23 March 2017
Norman E. Booth, PhD, FInstP
Emeritus Fellow in Physics
Mansfield College
University of Oxford
Oxford, UK
Joan Crawford, CPsychol, CEng, CSci, MA, MSc
Chartered Counselling Psychologist
Chronic Pain Management Service
St Helens Hospital
St Helens, UK
Lucy Dechene, PhD
Professor of Mathematics (retired)
Fitchburg State University
Fitchburg, Massachusetts, USA
Valerie Eliot Smith
Barrister and Visiting Scholar
Centre for Commercial Law Studies
Queen Mary University of London
London, UK
Margaret C. Fernald, PhD
Clinical and Research Psychologist
University of Maine
Orono, Maine, USA
Simin Ghatineh, MSc, PhD
Biochemist
London, UK
Alan Gurwitt, M.D.
Former Clinical Child Psychiatry Faculty Member
Yale Child Study Center, New Haven, Connecticut
University of Connecticut School of Medicine, Farmington, Connecticut
Harvard Medical School, Boston, Massachusetts
Co-author of primers on Adult and Pediatric ME/CFS
Clinician in Private Practice (retired)
Boston, Massachusetts, USA
Geoffrey Hallmann, LLB, DipLegPrac
Former Laywer, (Disability And Compensation)
Lismore, Australia
Susan Levine, MD
Clinician in Private Practice
New York, New York, USA
Visiting Fellow
Cornell University
Ithaca, New York, USA
Marvin S. Medow, Ph.D.
Professor of Pediatrics and Physiology
Chairman, New York Medical College IRB
Associate Director of The Center for Hypotension
New York Medical College
Hawthorne, New York, USA
Sarah Myhill MB BS
Clinician in Private Practice
Knighton, UK
Pamela Phillips, Dip, Dip. MSc MBACP (registered)
Counsellor in Private Practice
London, UK
Gwenda L Schmidt-Snoek, PhD
Researcher
Former Assistant Professor of Psychology
Hope College
Holland, Michigan, 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, UK
Samuel Tucker, MD
Former Assistant Clinical Professor of Psychiatry
University of California, San Francisco
San Francisco, California, USA
AM Uyttersprot, MD
Neuropsychiatrist
AZ Jan Portaels
Vilvoorde, Belgium
Paul Wadeson, Bsc, MBChB, MRCGP
GP Principal
Ash Trees Surgery
Carnforth, UK
ME/CFS Patient Organizations
25% ME Group
UK
Emerge Australia
Australia
European ME Alliance:
Belgium ME/CFS Association
Belgium
ME Foreningen
Denmark
Suomen CFS-Yhdistys
Finland
Fatigatio e.V.
Germany
Het Alternatief
Netherlands
Icelandic ME Association
Iceland
Irish ME Trust
Ireland
Associazione Malati di CFS
Italy
Norges ME-forening
Norway
Liga SFC
Spain
Riksföreningen för ME-patienter
Sweden
Verein ME/CFS Schweiz
Switzerland
Invest in ME Research
UK
Hope 4 ME & Fibro Northern Ireland
UK
Irish ME/CFS Association
Ireland
Massachusetts CFIDS/ME & FM Association
USA
ME Association
UK
ME/cvs Vereniging
Netherlands
National ME/FM Action Network
Canada
New Jersey ME/CFS Association
USA
Pandora Org
USA
Phoenix Rising
International membership representing many countries
Solve ME/CFS Initiative
USA
Tymes Trust (The Young ME Sufferers Trust)
UK
Wisconsin ME and CFS Association
USA
New Organizations added 23 March 2017
Action CND
Canada
Associated New Zealand ME Society
New Zealand
Chester MESH (ME self-help) group
Chester, UK
German Society for ME/CFS (Deutsche Gesellschaft für ME/CFS)
Germany
Lost Voices Stiftung
Germany
M.E. Victoria Association
Canada
ME North East
UK
ME Research UK
UK
ME Self Help Group Nottingham
UK
ME/CFS and Lyme Association of WA, Inc.
Australia
ME/CFS (Australia) Ltd
Australia
ME/CFS Australia (SA), Inc.
Australia
ME/CVS Stichting Nederland
Netherlands
ME/FM Myalgic Encephalomyelitis and Fibromyalgia Society of British Columbia
Canada
USA
Canada
UK
(Steungroep ME en Arbeidsongeschiktheid)
Groningen, Netherlands
[1] White PD, Goldsmith K, Johnson AL, et al. 2013. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine 43(10): 2227-2235.
[2] White PD, Goldsmith KA, Johnson AL, et al. 2011. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. The Lancet 377: 823–836
[3] Racaniello V. 2016. An open letter to The Lancet, again. Virology Blog, 10 Feb. Available at: https://www.virology.ws/2016/02/10/open-letter-lancet-again/ (accessed on 2/24/17).
[4] White PD, Sharpe MC, Chalder T, et al. 2007. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurology 7: 6.
[5] Tuller D. 2015. Trial by error: the troubling case of the PACE chronic fatigue syndrome trial. Virology Blog, 21-23 Oct. Available at: https://www.virology.ws/2015/10/21/trial-by-error-i/ (accessed on 2/24/17)
[6] Wilshire C, Kindlon T, Matthees A, McGrath S. 2016. Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial. Fatigue: Biomedicine, Health & Behavior; published online 14 Dec. Available at: http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1259724 (accessed on 2/24/17)
[7] PACE Participants Newsletter. December 2008. Issue 3. Available at: http://www.wolfson.qmul.ac.uk/images/pdfs/participantsnewsletter3.pdf (accessed on 2/24/17).
[8] Sharpe M, Chalder T, Johnson AL, et al. 2017. Do more people recover from chronic fatigue syndrome with cognitive behaviour therapy or graded exercise therapy than with other treatments? Fatigue: Biomedicine, Health & Behavior; published online 15 Feb. Available at: http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1288629 (accessed on 2/24/17).
[9] Green CR, Cowan P, Elk R. 2015. National Institutes of Health Pathways to Prevention Workshop: Advancing the research on myalgic encephalomyelitis/chronic fatigue syndrome. Annals of Internal Medicine 162: 860-865.
Comments
27 responses to “An open letter to Psychological Medicine, again!”
From Gail Kansky:
Please add our name to this list, Tom. Thanks.
National CFIDS Foundation, Inc.
USA
This reply is desperate to avoid conflict with PACE authors.
Great to see more signatures added to this letter.
Thanks to all of them.
Thanks to all new signatories and anyone supporting us in our fight to have this illness finally being taken seriously. I doubt we could have come this far without your help.
I would have been surprised if Murray had done anything. He and the editorial team have been aware of factual errors in the paper and the reasoning behind it shortly after publication and have failed to act. In fact his response to patients pointing out issues with the paper was very vigorous in support of his colleagues who were involved with the paper.
Perhaps the other editor would act more ethically if he thought that being an editor of a journal that knowingly misleads patients and clinical decision makers would reflect on his reputation.
Until that point I think it is important to note that it is not just that science does not proceed in this manner but Murray’s actions are unethical.
Given the journal is published by Cambridge university press I wonder what they think of such issues and failures to investigate. Has anyone asked the Cambridge vice chancellor for an interview on the subject. Perhaps it is notable that Ross Anderson a Cambridge academic did his best to stop the data being released.
Perhaps if journals were legally liable for the papers they publish then the situation may be different. But in the UK judges can do strange things like ignore legal disclaimers especially where normal practice has not been followed.
For some reason, some groups were missed when this was updated. Hopefully this will be sorted soon:
MEAction
International membership representing many countries
Millions Missing Canada
Canada
National CFIDS Foundation, Inc.
USA
North London ME Network
UK
OMEGA (Oxfordshire ME Group for Action)
UK
Open Medicine Foundation
USA
Quebec ME Association
Canada
The York ME Community
UK
Welsh Association of ME & CFS Support
UK
Once again thanks are due to the team at Virology blog working on this and the new signatories. If the PACE PIs weren’t already an international laughing stock they are now. This is reaching such levels of absurdity that it’s hard to believe such goings on’ could ever happen in academia … particularly with regard to journal editors (and I include Horton in that statement ) who simply won’t capitulate and accept that they have fraudulent papers on their books. What does this do to their reputations and the impact factors of the journals under their editorship? All very, very peculiar.
Thank you!
Is it at all possible we are witnessing Peer-review fraud/Research publication policy over and above evidential Scientific integrity? PACE Trial therapies have been recommend by NICE and the NHS long before the the paper was even peer reviewed & accepted.
Even after the prohibited blood donation policy came into effect in 2010, stating ME/CFS patients can no longer donate even if considered recovered, this was prior to the PACE publication. If NHS Blood & Transfusion services dont accept full recovery is possible, how can any future, subjective trial suggest this?
The longer this drags on, the more it stinks to high heaven. Is corruption really at play here? And how can we see a possible resolution?
You can really get the measure from this post of how impenetrable this wall has been for so long for so many patients and their families and advocates. I salute you for your dedication and perseverance.
One erratum for your letter – the opening of the letter should be addressing Sir Robin and Dr Kendler – or Sir Robin Murray and Dr Kendler (to make it clear that they aren’t a married couple sharing a surname!), or better yet if you can switch the names without loss of implied precedence, Dr Kendler and Sir Robin. But “Sir Murray” doesn’t exist and shouldn’t be addressed!
(I remember it like this: a knighthood is attached to the individual, not the family.)
That nitpicking aside, thank you for all your efforts, and thank you to all the signatories for their support (especially the two from QMUL!). My cynical and weary side can’t even begin to imagine the editors of Psychological Medicine backing down and admitting they’ve been wrong, much less actually retracting the paper(s)…but I’d very much like to be wrong about that.
This might be extreme and I do not have the energy to read all the details but the word “fraud” is in my mind. If there is direct written evidence (as opposed to simple opinion) of behaviour that is deliberately misleading so as to amount to being fraudulent in effect and that fraud could be linked to any financial gain (say further government funding) I ask myself whether that may amount to the criminal offence of ‘obtaining a pecuniary advantage by deception’.
A.T. Brown
“That the editors of Psychological Medicine do not grasp that it is impossible to be “disabled” and “recovered” simultaneously on an outcome measure is astonishing and deeply troubling.”
I am quite confident they do grasp it, but are extremely loathe/frightened to publicly own up, explicitly or tacitly. Probably feel obfuscation is their best chance of squirming out of the hole they are finding themselves in.
Sir Robin Murray, actually that’s NOT how science works, however that IS how FRAUD works…
To the author’s of the PACE trial, there is no way out of this sorry mess, the time has come to step down gracefully, take responsibility, admit you got things very wrong and offer a full public apology to ME patients around the world who have been harmed as a result of the PACE trial papers.
Well that would be the acts of an ethical, moral human being, some one with graciousness, dignity, humility and respect for their fellow human beings.
You can choose to admit you got it wrong graciously or continue to play dirty and throw your toys out of the pram and look more and more foolish every time you attempt to defend your flawed research, but the illusion has been shattered as have your credibility, it’s over.
So Robin Murray is ok with fraudulent research in his journal? Ridiculous.
Thanks again to all involved.
Have any researchers come forward willing to do the necessesary reanalysis from the data showing how patients do not improve and in this way overrun that awful bad PACE-trial. If that is what it takes?
All trust is gone in the correct way to carry research forward, along with the reputation of researches and their papers in the UK. Journals, are being used at the will of the researchers? Our reputation in the UK will be marked for years as the truth unfolds. It is now OK to harm patients in trials in the UK?
Now a PACE trial for children will be doing the same. MAGENTA is based on PACE, there will be no reporting on harms to daily life, and no data will be given to parents to enable them to make informed choice. Though parents will be blamed for the failure of the trial, as it was with SMILE trial. Fitnet-NHS another exercise mind over pain approach. The ripples of this inaction reaches the innocent and washes over them, drowning their plight from clear sight. Those that should protect them, have now turn their backs and sealed their fate.
The PACE trial & the whole 30 plus years transmogrification of ME has been built on conflicts of interest, and an effort to make it very difficult for people to have health insurance/welfare claims accepted. To have relevant and extensive diagnostic testing performed and accepted to disprove the PACE myth. UK welfare & NHS funding has been cut to ribbons and it’s patient healthcare which will feel the brunt.
And now I suspect the PACE proponents are in the midst of a new and improved model to disguise the devastation of ME: Medically Unexplained Symptoms. A larger waste-basket to throw patients in.
http://www.nhs.uk/conditions/medically-unexplained-symptoms/Pages/Somatisation.aspx#Causes
https://uploads.disquscdn.com/images/d2153690d85466b1076d8ecd82278b9e44451137e1cad609ab8c64bb96893efe.jpg
The sad thought is the NHS cannot afford the care for patients, and will allow modern-day snake-oil salesmen to masquerade as scientists who can avoid any responsibility in order to save the governments money.
These charlatans are clearly well protected.
Not surprising they refuse to retract. Sharpe and Wessely are on the Editorial Board (and Carmine of MEGA is an Associate-Editor)https://www.cambridge.org/core/journals/psychological-medicine/information/editorial-board
Sincere and heartfelt thanks to all involved, again! Very impressive and heartwarming list of signatories, I hope they all know how deeply appreciated their continued efforts and support are. Fantastic, keep it up!
Link is in the first letter above – http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1259724
Thank you so much Dr. Tuller, Prof. Racaniello and all the signatories!! Science must prevail!
Also saw Matthew Hotopf is on their Editorial Board!
Wessley, Hotopf, Pariante and Robin Murray (one of the journal’s two editors, and the one who responded to the letter) and three others on the Editorial Board all work at King’s College Institute of Psychiatry.
Sir Robin Murray responds “Presumably, interested parties will now be able to read this reanalysis and compare the scientific qualiity of the re-analysis with that of the original. My understanding is that this is the way that science advances.”
The PACE trial as Robin Murray should know now was a fraud masquerading as science. The problems have been raised numerous times but have been ignored. The PACE trial and its authors for the last 30 years have not only not advanced science but have actually hindered science. Since their involvement in muddying the definitions of ME with the term CFS in addition to the other issues Dr Tuller has investigated it has put back the state of knowledge in ME because of the misleading and what can only be described as deceptive propaganda put out by these psychiatric proponents.
There is considerable evidence of this in the scientific literature and also on the internet which Murray will or should be aware of but two examples are provided here which Robin Murray should be well aware of. The PACE trial was an unprecedented form of political spin and economic project to support terminating benefits and not “science”.
This is now being brought to the wider attention of the public. Murray will be aware of the background but it is reiterated here. The 64 page report ‘In the expectation of recovery’ examines in detail the financial motive of the PACE authors and the insurance article by Dr Tuller also explains this further.
http://www.centreforwelfarereform.org/library/type/pdfs/in-the-expectation-of-recovery.html
https://www.virology.ws/2015/11/17/trial-by-error-continued-pace-teams-work-for-insurance-companies-not-related-to-pace-really/
Sir Robin will be well aware that the science in the PACE trial was not just unintentionally poor or careless but designed to mislead and harm ME patients for the benefits of the PACE trial authors and their associates.
Murray is clearly a smart man and he can surely now see the PACE trial for what it was – scientific fraud. He has now been made fully aware of the issues and has a professional and ethical duty to retract the publication given the evidence before him and the ongoing harm to patients. Otherwise what is he gaining from this situation?
The question is not if the PACE trial will be retracted and the PACE authors (and those involved who stood by) fully exposed to the opprobrium of the media, general public and society as a whole but when.
Surely under this weight of evidence and the knowledge of leading scientific minds globally they will retract? They are in the spotlight. To not retract is a disgrace.