By David Tuller, DrPH
Last week, I reported that Bristol University had launched an independent investigation of research led by Professor Esther Crawley, at the request of the UK’s Health Research Authority. Today, the HRA released a report on the PACE trial that has portrayed it as a well-conducted study. GET/CBT supporters are framing this report as a vindication.
In contrast, Professor Bruce Levin, a well-known biostatistician at Columbia, used this choice phrase when discussing PACE–“the height of clinical trial amateurism.” Professor Levin gave a talk last summer titled “How NOT to Conduct a Randomized Clinical Trial,” with PACE as the case study. As I have often noted, epidemiology professors at Berkeley have used PACE in their classes as an excellent example of terrible research. I’ve mostly called it “a piece of crap.”
In assessing the HRA’s findings, it is important to remember that the agency’s remit is relatively narrow, it focuses on process. As the report notes: Our concern as a regulator is whether the study was properly approved by the Research Ethics Committee (REC).
The report includes this important disclaimer: It would not be appropriate for the HRA to seek to resolve…debates about the quality of the study. Discussion of the meaning and robustness of results is how science is expected to proceed.
And this: We also note that some of the criticisms of the PACE trial which have been brought to our attention are outside our regulatory remit and so we are not in a position to comment on them.
I disagree with many aspects of this report and will discuss my concerns at length at a later point. But any claim that the HRA has given PACE a blanket clean bill of health is going way beyond what the report itself states. Unfortunately, that won’t stop the GET/CBT ideological brigades from pressing that argument.
Significantly, the HRA report focuses on the 2011 Lancet paper and ignores the 2013 “recovery” paper in Psychological Medicine. For that paper, the investigators made the unilateral decision to weaken all four of the recovery criteria laid out in their protocol because, as they have explained, they determined that their initial assessment methods were too stringent to demonstrate “recovery.” In other words, they were concerned that their reported “recovery” rates would be too low.
It is obvious, of course, that if you weaken measures because they are too “stringent,” you will automatically get results that look better than those you would have otherwise been able to report. The investigators received no apparent oversight committee approvals for this decision–at least, none is mentioned in the 2013 paper. Obviously, had they received such approvals, they would have cited this fact in defense of their dramatic outcome-switching. It is unclear why the HRA chose to omit this paper from its review of the matter.
For now, I am reposting Virology Blog’s open letter to Dr Richard Horton, editor of The Lancet, from last August. That letter called out PACE’s unacceptable methodological lapses and was signed by 114 scientists, academics and other experts. It was also signed by ten members of Parliament and many dozens of patients and advocacy organizations.
The criticisms outlined in this open letters have not been rebutted by the HRA report. The PACE study and resulting papers are still fraught with “unacceptable methodological lapses.”
**********
Dear Dr. Horton:
In February, 2011, The Lancet published an article called Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized trial. [1] The article reported that two rehabilitative approaches, cognitive behavioural therapy (CBT) and graded exercise therapy (GET), were effective and safe treatments for chronic fatigue syndrome, also often referred to as myalgic encephalomyelitis, ME/CFS and CFS/ME. The PACE study received international attention and has had widespread influence on research, treatments prescribed for patients, and attitudes toward the illness of both the medical community and the public at large.
At the press conference promoting the Lancet paper, one of the lead investigators stated that twice as many participants in the treatment groups got back to normal, compared to those in the other study arms. [2] An accompanying Lancet commentary similarly claimed that these back-to-normal participants had met a strict criterion for recovery. [3]
In fact, we now know that 13 % of the participants qualified at baseline as recovered or within the normal range for one of the study’s two primary measures, self-reported physical function–even as they were simultaneously classified as disabled enough on the same measure to enter the study. [4] This anomaly, which occurred because the investigators weakened key outcome thresholds after data collection, invalidates any claims that patients recovered or got back to normal. The overlap in entry and outcome criteria is only one of the trial’s unacceptable methodological lapses.
The treatments investigated in the PACE trial were based on the hypothesis that ME/CFS patients harbor unhelpful convictions about having an ongoing organic disease and that the perpetuation of their devastating symptoms is the result of deconditioning. In contrast, a 2015 review from the U.S. Institute of Medicine (now the National Academy of Medicine), reported that ME/CFS is a complex, multi-system illness characterized by neurological, immunological, autonomic, and energy metabolism dysfunctions. [5] The cardinal symptom, noted the review, is a systemic intolerance to exertion; if patients exceed their available energy resources, they can suffer serious and prolonged relapses.
After The Lancet published the first PACE results, ME/CFS patients and advocates immediately pointed out major flaws. But few people outside the field took notice until the science site Virology Blog published a 15,000-word investigation by David Tuller, a public health researcher and journalist at the University of California, Berkeley, in October of 2015. [6] Subsequently, in February of 2016, many of us signed an open letter to The Lancet requesting an independent investigation of the study. [7]
Since then, much has happened:
* In August of 2016, a U.K. tribunal, citing that open letter, ordered Queen Mary University of London to release raw trial data from the PACE study, sought by Australian patient Alem Matthees in a freedom of information request so that he and others could calculate the outcomes promised in the PACE trial protocol. [8]
* Analyses of these data [9], including a study published in BMC Psychology in March [10], have confirmed what has long been argued: The PACE investigators engaged in such extensive outcome-switching that they were able to report dramatically better findings than the null or minimal results obtained under the original measures they promised in their protocol.
* The U.S. Agency for Healthcare Research and Quality (AHRQ) downgraded its recommendations for CBT and GET. [11] This downgrading occurred after the agency removed from its analysis the PACE trial and other studies using overly broad selection criteria that generated cohorts of patients with a grab-bag of fatiguing conditions. And while the PACE trial claimed that GET is safe, AHRQ found that the therapy was associated with more adverse events.
* Last summer, the U.S. Centers for Disease Control abandoned the recommendations that ME/CFS patients be treated with CBT and GET [12], having already removed references to the PACE trial. A couple of months later, the U.K. National Institute for Health and Care Excellence announced that it would pursue a full update of its 2007 guidance, citing concerns about the reliability and validity of the evidence base. [13]
* Earlier this year, a report from the Dutch Health Council recommended that GET should not be used in the Netherlands as a treatment for the illness. [14]
* In March, a group of leading American clinicians who specialize in ME/CFS unanimously agreed that the two PACE treatments are inappropriate and possibly harmful for patients with the illness and should therefore not be prescribed. [15]
Given the worldwide impact of PACE, we urge The Lancet to do what the open letter two years ago requested: commission an independent re-analysis of the individual-level trial data, with appropriate sensitivity analyses, from highly respected reviewers with extensive expertise in statistics and study design. The reviewers should be from outside the domains of psychiatry and psychological medicine and predominantly from outside the U.K. They should also be completely independent of, and have no conflicts of interests involving, the PACE investigators and the funders of the trial.
Thank you for your quick attention to this matter.
Sincerely,
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
Lisa Alioto, JD
Vice President
Minnesota ME/CFS Alliance
Edina, Minnesota, USA
Michael Allen, PhD
Clinical Psychologist (retired)
San Francisco, California, USA
Christopher Armstrong, PhD
Bio21 Molecular Science & Biotechnology Institute
Department of Biochemistry and Molecular Biology
University of Melbourne
Melbourne, Victoria, Australia
James N. Baraniuk, MD
Professor of Medicine
Georgetown University
Washington, DC, USA
Lisa F. Barcellos, 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
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
John Chia, MD
Physician and Researcher
EV Med Research
Lomita, California, USA
Lily Chu, MD, MSHS
Independent Researcher
Burlingame, California, USA
Barbara Comerford, JD
Attorney in Private practice
Specialist in Disability Law
Paramus, New Jersey, USA
Joan Crawford, CPsychol, CEng, CSci, MA, MSc
Chartered Counselling Psychologist
Chronic Pain Management Service
St Helens Hospital
St Helens, England, UK
Janet L Dafoe, PhD
Child Psychologist in Private Practice
Palo Alto, California, USA
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Professor and Program Director
Department of Physical Therapy
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University of the Pacific
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Workwell Foundation
Ripon, California, USA
Ronald W. Davis, PhD
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Stanford University
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Lucy Dechene, PhD
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Fitchburg State University
Fitchburg, Massachusetts, 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
Derek Enlander, MD
Clinician in private practice
New York, New York, USA
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Clinical Psychologist and Researcher
Chicago, Illinois, USA
W.A. Faas, MD, LL.M
Insurance Physician
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Amsterdam, The Netherlands
Margaret C. Fernald, PhD
Clinical Associate
Department of Psychology
University of Maine
Orono, Maine, USA
Mary Ann Fletcher, PhD
Schemel Professor of NeuroImmune Medicine
Nova Southeastern University
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University of Miami School of Medicine
Fort Lauderdale, Florida, USA
Kenneth J. Friedman, PhD
Associate Professor of Physiology and Pharmacology (retired)
New Jersey Medical School
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Newark, New Jersey, USA
Robert F. Garry, PhD
Professor of Microbiology and Immunology
Tulane University School of Medicine
New Orleans, Louisiana, USA
Keith Geraghty, MPH, PhD
Honorary Research Fellow
Division of Population Health, Health Services Research & Primary Care
School of Health Sciences
University of Manchester
Manchester, England, UK
Simin Ghatineh, MSc, PhD
Biochemist
London, England, 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, England, UK
Claudia Gillberg, PhD
Fellow, Centre for Welfare Reform
Sheffield, England, UK
Senior Research Associate
National Centre for Lifelong Learning
Jonkoping University
Jonkoping, Sweden
Mike Godwin, JD
Attorney and Author
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R Street Institute
Washington, DC, USA
Rebecca Goldin, PhD
Professor of Mathematics
George Mason University
Fairfax, Virginia, USA
Alan Gurwitt, MD
Clinician 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
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Boston, Massachusetts, USA
Geoffrey Hallmann, LLB, DipLegPrac
Specialist in Disability and Compensation Law (retired)
Lismore, New South Wales, Australia
Maureen Hanson, PhD
Liberty Hyde Bailey Professor
Department of Molecular Biology and Genetics
Cornell University
Ithaca, New York, USA
Malcolm Hooper, PhD, BPharm, MRIC, CChem
Emeritus Professor of Medicinal Chemistry
University of Sunderland
Tyne and Wear, England, UK
Leonard A. Jason, PhD
Professor of Psychology
DePaul University
Chicago, Illinois, USA
Daniel Kahn, MD
Professor of Radiology
Carver College of Medicine
University of Iowa Health Care
Chief, Nuclear Medicine Section
Iowa City Veteran’s Affairs Medical Center
Iowa City, Iowa, USA
Michael W. Kahn, MD
Assistant Professor of Psychiatry
Harvard Medical School
Boston, Massachusetts, USA
Keith Kahn-Harris, PhD
Associate Lecturer in Sociology
Birkbeck, University of London
London, England, UK
Jon D. Kaiser, MD
Clinical Faculty
Department of Medicine
University of California, San Francisco
San Francisco, California, USA
David L. Kaufman, MD
Center for Complex Diseases
Mountain View, California
Member, The ME/CFS Collaborative Research Center at Stanford
Palo Alto, California, USA
Betsy Keller, PhD, FACSM
Professor of Exercise & Sport 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
Open Medicine Institute
Mountain View, California, USA
Anthony L. Komaroff, MD
Simcox-Clifford-Higby Distinguished Professor of Medicine
Harvard Medical School
Senior Physician
Brigham and Women’s Hospital
Boston, Massachusetts, USA
Richard Kwiatek, MBBS, FRACP
Rheumatologist and Independent Researcher
Northern Adelaide Local Health Network
Adelaide, South Australia, Australia
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
Charles W. Lapp, MD
Medical Director
Hunter-Hopkins Center
Charlotte, North Carolina, USA
Keith R. Laws, PhD
Professor of Neurocognitive Psychology
School of Psychology
University of Hertfordshire.
Hertfordshire, England, UK
Bruce Levin, PhD
Professor of Biostatistics
Columbia University
New York, New York, USA
Donald Lewis, MBBS, FRACGP, DRACOG
Medical Director
CFS Discovery
Melbourne, Victoria, Australia
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
Rogier Louwen, PhD
Assistant Professor
Department of Medical Microbiology and Infectious Diseases
Erasmus University Medical Center
Rotterdam, The Netherlands
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, JD
Williams Memorial Professor of Law
Northwestern University Pritzker School of Law
Chicago, Illinois, USA
Kristin Luker, PhD
Professor of Sociology Emerita
Professor of Law Emerita
Founding Director, Center on Reproductive Rights and Justice
University of California, Berkeley
Berkeley, California, USA
Darren Lynch, MD
Northampton Integrative Medicine
Northampton, Massachusetts, USA
Countess of Mar
House of Lords
Chair, Forward-ME
London, England, UK
David F. Marks, PhD
Editor
Journal of Health Psychology
& Health Psychology Open
London, England, UK
Sonya Marshall-Gradisnik, PhD
Professor of Immunology
Co-Director, National Centre for Neuroimmunology and Emerging Diseases
Griffith University
Gold Coast, Queensland, Australia
Marlon Maus, MD, DrPH, FACS
DrPH Program Director
School of Public Health
University of California, Berkeley
Berkeley, California, USA
Neil R McGregor, BDS, MDSc, PhD
Clinical Associate Professor
Faculty of Medicine, Dentistry and Health Sciences
Bio21 Molecular Science & Biotechnology Institute
University of Melbourne.
Melbourne, Victoria, Australia
Patrick E. McKnight, PhD
Professor of Psychology
George Mason University
Fairfax, Virginia, USA
Marvin S. Medow, PhD
Professor of Pediatrics and Physiology
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New York Medical College
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Peter G. Medveczky, MD
Professor of Molecular Medicine
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Jose G. Montoya, MD, FACP, FIDSA
Professor of Medicine
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Stanford University School of Medicine
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National Reference Center for the Study and Diagnosis of Toxoplasmosis
Palo Alto, California, USA
Sarah Myhill, MBBS
Clinician in Private Practice
Knighton, Wales, UK
Luis Nacul, MD, PhD
Clinical Associate Professor
International Centre for Evidence in Disability
Faculty of Infectious and Tropical Diseases
London School of Hygiene & Tropical Medicine
London, England, UK
Zaher Nahle, PhD, MPA
Executive Director
Arthritis National Research Foundation
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Chief Executive Officer
Emerge Australia
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François-Xavier Bagnoud Professor of Pediatrics
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Department of Pediatrics
Rutgers New Jersey Medical School
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Elisa Oltra, PhD
Professor of Molecular and Cellular Biology
Catholic University of Valencia School of Medicine
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Nigel Paneth, MD, MPH
University Distinguished Professor
Department of Epidemiology & Biostatistics
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College of Human Medicine
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Psychologist in Private Practice
Rolling Ground, Wisconsin, USA
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Peter C. Rowe, MD
Professor of Pediatrics
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Michael Scott, PhD
Clinician and Researcher
Psychological Therapies Unit
Liverpool, England, UK
Sarah Selke, MB BCh BAO, CCFP
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Environmental Health Clinic
Women’s College Hospital
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Charles Shepherd, MBBS
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Buckingham, England, UK
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Scientific Director
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Ripon, California, USA
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Psychiatrist in Private Practice
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University of Calgary
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Ripon, California, USA
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New York Medical College
Hawthorne, New York, USA
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
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Ronald G. Tompkins, MD, ScD
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Assistant Clinical Professor of Psychiatry (retired)
University of California, San Francisco
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Center for Global Public Health
School of Public Health
University of California, Berkeley
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Physician, Independent Researcher
Palm Coast, Florida, USA
Derya Unutmaz, MD
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Farmington, Connecticut, USA
A.M. Uyttersprot, MD
Neuropsychiatrist
AZ Jan Portaels
Vilvoorde, Belgium
Rosamund Vallings, MNZM, MBBS
General Practitioner
Auckland, New Zealand
Linda van Campen, MD
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Hoofddorp, The Netherlands
Mark VanNess, PhD
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University of the Pacific
Stockton, California, USA
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Ripon, California, USA
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
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University of Birmingham
Birmingham, England, UK
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University of Kent
Canterbury, England, UK
William Weir, FRCP
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London, England, UK
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Brisbane, Queensland, Australia
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Los Angeles, California, USA
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School of Psychology
Victoria University of Wellington
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DePaul University
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Associate Editor, BMC Journal of Translational Medicine
__________
Members of Parliament
Sir Edward Davey MP
Kingston and Surbiton, England, UK
David Drew MP
Stroud, England, UK
Patricia Gibson MP
North Ayrshire and Arran, Scotland, UK
Mary Glindon MP
North Tyneside, England, UK
Sandy Martin MP
Ipswich, England, UK
Carol Monaghan MP
Glasgow North West, Scotland, UK
Nicky Morgan MP
Loughborough, England, UK
Alex Sobel MP
Leeds North West, England, UK
Graham Stringer MP
Blackley and Broughton, England, UK
Stephen Timms MP
East Ham, England, UK
__________
Patient/Advocacy Organizations
25% ME GROUP
Support for severe ME sufferers
UK
Action CND
Canada
Action for ME
UK
American ME and CFS Society
USA
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New Zealand
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UK
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Chester, UK
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UK
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Australia
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UK
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Germany
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USA
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Belgium
WAMES (Welsh Association of ME & CFS Support)
Wales, UK
Wisconsin ME and CFS Association
USA
York ME Community
UK
___________
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[8] Rehmeyer J. 2016. Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back. STAT, 21 Sept. Available at: https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/ (accessed on April 23, 2018)
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