Science Media Centre expert reaction to Journal of Health Psychology’s Special Issue on The PACE Tri

[Countrygirl]

Dear Professor Macleod,

Please help me out here.

Am I to understand that you maintain that many/all/some ? of the following people are of 'doubtful provenance' as they have either published in the JHP special edition on PACE or share the same view? Please will you provide evidence for your claim as I am not a scientist, and would be grateful if you would advise us who to ignore and why. That would be so helpful.

I look forward to your answer with anticipation.

Just to refresh your memory of the individuals to whom you are probably referring.


Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Stanford University

Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London

Leonard A. Jason, PhD
Professor of Psychology
DePaul University

Bruce Levin, PhD
Professor of Biostatistics
Columbia University

Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
Columbia University

Arthur L. Reingold, MD
Professor of Epidemiology
University of California, Berkeley

****

Dharam V. Ablashi, DVM, MS, Dip Bact
Scientific Director, HHV-6 Foundation
Former Senior Investigator
National Cancer Institute, NIH
Bethesda, Maryland

James N. Baraniuk, MD
Professor, Department of Medicine,
Georgetown University
Washington, D.C.

Lisa F. Barcellos, PhD, MPH
Professor of Epidemiology
School of Public Health
California Institute for Quantitative Biosciences
University of California
Berkeley, California

Lucinda Bateman, MD
Medical Director, Bateman Horne Center
Salt Lake City, Utah

David S. Bell, MD
Clinical Associate Professor of Pediatrics
State University of New York at Buffalo
Buffalo, New York

Alison C. Bested MD FRCPC
Clinical Associate Professor of Hematology
University of British Columbia
Vancouver, British Columbia, Canada

Gordon Broderick, PhD
Director, Clinical Systems Biology Group
Institute for Neuro Immune Medicine
Professor, Dept of Psychology and Neuroscience
College of Psychology
Nova Southeastern University
Miami, Florida

John Chia, MD
Clinician/Researcher
EV Med Research
Lomita, California

Lily Chu, MD, MSHS
Independent Researcher
San Francisco, California

Derek Enlander, MD, MRCS, LRCP
Attending Physician
Mount Sinai Medical Center, New York
ME CFS Center, Mount Sinai School of Medicine
New York, New York

Mary Ann Fletcher, PhD
Schemel Professor of Neuroimmune Medicine
College of Osteopathic Medicine
Nova Southeastern University
Professor Emeritus, University of Miami School of Medicine
Fort Lauderdale, Florida

Kenneth Friedman, PhD
Associate Professor of Pharmacology and Physiology (retired)
New Jersey Medical School
University of Medicine and Dentistry of NJ
Newark, New Jersey

David L. Kaufman, MD,
Medical Director
Open Medicine Institute
Mountain View, California

Nancy Klimas, MD
Professor and Chair, Department of Clinical Immunology
Director, Institute for Neuro-Immune Medicine
Nova Southeastern University
Director, GWI and ME/CFS Research, Miami VA Medical Center
Miami, Florida

Charles W. Lapp, MD
Director, Hunter-Hopkins Center
Assistant Consulting Professor at Duke University Medical Center
Charlotte, North Carolina

Susan Levine, MD
Clinician, Private Practice
New York, New York
Visiting Fellow, Cornell University
Ithaca, New York

Alan R. Light, PhD
Professor, Department of Anesthesiology and Department of Neurobiology and Anatomy
University of Utah
Salt Lake City, Utah

Sonya Marshall-Gradisnik, PhD
Professor and Co-Director
National Centre for Neuroimmunology and Emerging Diseases
Griffith University
Queensland, Australia

Peter G. Medveczky, MD
Professor, Department of Molecular Medicine, MDC 7
College of Medicine
University of South Florida
Tampa, Florida

Zaher Nahle, PhD, MPA
Vice President for Research and Scientific Programs
Solve ME/CFS Initiative
Los Angeles, California

James M. Oleske, MD, MPH
Francois-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

Richard N. Podell, M.D., MPH
Clinical Professor
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey

Charles Shepherd, MB, BS
Honorary Medical Adviser to the ME Association
London, United Kingdom

Christopher R. Snell, PhD
Scientific Director
WorkWell Foundation
Ripon, California

Nigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH
Pediatrician
County Durham, United Kingdom

Donald Staines, MBBS MPH FAFPHM FAFOEM
Professor and 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

Eleanor Stein, MD FRCP(C)
Assistant Clinical Professor
University of Calgary
Calgary, Alberta, Canada

John Swartzberg, MD
Clinical Professor Emeritus
School of Public Health
University of California, Berkeley
Berkeley, California

Ronald G. Tompkins, MD, ScD
Summer M Redstone Professor of Surgery
Harvard University
Boston, Massachusetts

Rosemary Underhill, MB BS.
Physician, Independent Researcher
Palm Coast, Florida

Dr Rosamund Vallings MNZM, MB BS
General Practitioner
Auckland, New Zealand

Michael VanElzakker, PhD
Research Fellow, Psychiatric Neuroscience Division
Harvard Medical School & Massachusetts General Hospital
Boston, Massachusetts

William Weir, FRCP
Infectious Disease Consultant
London, England

Marcie Zinn, PhD
Research Consultant in Experimental Neuropsychology, qEEG/LORETA, Medical/Psychological Statistics
NeuroCognitive Research Institute, Chicago
Center for Community Research
DePaul University
Chicago, Illinois

Mark Zinn, MM
Research consultant in experimental electrophysiology
Center for Community Research
DePaul University
Chicago, Illinois

 

[Jonathan Edwards]

Dear Professor Macleod,

Please help me out here.

Did you send it to him?

Malcolm.Macleod@ed.ac.uk

 

[CFS_for_19_years]

Dear Professor Macleod,

Please help me out here.

Am I to understand that you maintain that many/all/some ? of the following people are of 'doubtful provenance' as they have either published in the JHP special edition on PACE or share the same view? Please will you provide evidence for your claim as I am not a scientist, and would be grateful if you would advise us who to ignore and why. That would be so helpful.
......

That's a sketchy bunch of people alright.

 

[CFS_for_19_years]

Prof. Malcolm Macleod, Professor of Neurology and Translational Neuroscience, University of Edinburgh, said:

“The PACE trial, while not perfect, provides far and away the best evidence for the effectiveness of any intervention for chronic fatigue; and certainly is more robust than any of the other research cited. Reading the criticisms, I was struck by how little actual meat there is in them; and wondered where some of the authors came from. In fact, one of them lists as an institution a research centre (Soerabaja Research Center) which only seems to exist as an affiliation on papers he wrote criticising the PACE trial.

“Their main criticisms seem to revolve around the primary outcome was changed halfway through the trial: there are lots of reasons this can happen, some justifiable and others not; the main think is whether it was done without knowledge of the outcomes already accumulated in the trial and before data lock – which is what was done here.

“So I don’t think there is really a story here, apart from a group of authors, some of doubtful provenance, kicking up dust about a study which has a few minor wrinkles (as all do) but still provides information reliable enough to shape practice. If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…"

https://www.coyneoftherealm.com/blo...f-health-psychology-concerning-the-pace-trial

Another commentary was from Malcolm MacLeod, a former colleague of Michael Sharpe at University of Edinburgh, who also authored a paper with him. McLeod claims to have read the issue and found nothing of substance there. That was an amazing feat, because the Science Media Centre posted this critique only minutes before the special issue was available. We might conclude that McLeod is a speed reader. Judging from the superficiality of his comments, it could simply be a matter of his not having read the special issue.

 

[Sean]

the main think is whether [the changes to the primary outcome were] done without knowledge of the outcomes already accumulated in the trial and before data lock – which is what was done here.

You don't need to know what the data says to know that relaxing the outcome criteria is going to improve the outcome from that data.

 

[Yogi]

Declared interests

Prof. Macleod: “Prof Sharpe used to have an office next to my wife’s; and I sit on the PLoS Data board that considered what to do about one of their other studies.”

Dr. Issar-Brown: Nothing to declare

This COI disclosure is completely unsatisfactory. It is an attempt to mislead busy journalists.

1. Malcolm Macleod is trivialising the serious issue of COI disclosures with his wife's office next door and if he is being humorous it is not funny.

He FAILED to disclose the main COI with Sharpe.

Interventions for post-stroke fatigue with Michael Sharpe

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007030.pub3/abstract

The issue of serious COIs is very serious with PACE and central issue with flaw in the trial and should not be trivialised as they are now doing.

2. Neha Issar Brown states Nothing to Declare. However she is NOT an independent expert.
She is employed and receives most if not all her income from MRC. The MRC was the major funder (DWP funding minority) of the PACE trial and dismissed all complaints about it from 2003 onwards. PACE trial would not been done without blessing and funding from MRC.The MRC is referred to and that they funded in the brief but in the COI disclosure this should be clear.

It is not acceptable for Neha Issar Brown to sign off as "Nothing to declare" as it is untrue. If she was completing a professional disclosure form on COI's that is a false and misleading statement.

I am amazed that the MRC has such low standards. This explains partially the PACE debacle.

How have the MRC treated Sharpe, White and Chalder's COI disclosure forms?? It does not inspire any confidence.

 

[Jonathan Edwards]

This COI disclosure is completely unsatisfactory. It is an attempt to mislead busy journalists.

I am amazed that the MRC has such low standards.

Macleod co-authored a systematic review with Sharpe looking at treatment for stroke, which concluded that there was nothing to say. I do not think this constitutes any conflict of interest. Being a friend of someone is not a conflict of interest unless there is reason to expect financial or other gain.

I thin Dr Issar-Brown has made herself look rather ridiculous but she declares her role in the MRC in her introduction. It is made quite clear that she is giving the MRC view. The irony is that all it does is show that the MRC do NOT have robust peer review. Moreover, their staff are not up to speed on this. The result is rather pathetic. But nothing is concealed.

 

[Valentijn]

This COI disclosure is completely unsatisfactory. It is an attempt to mislead busy journalists.

I'm more concerned about the dozens, if not hundreds, of press releases issued by the Science Media Centre where they never disclose that they have been funded by institutions and industries that they promote and defend.

The SMC was funded by Queen Mary University London in the past, and they are accordingly conflicted regarding PACE and its authors. They also have colleagues of the PACE researchers (and probably various other interests) acting as part of their organization.

 

[Esther12]

Macleod co-authored a systematic review with Sharpe looking at treatment for stroke, which concluded that there was nothing to say. I do not think this constitutes any conflict of interest. Being a friend of someone is not a conflict of interest unless there is reason to expect financial or other gain.

I was unsure on that. I thought being a co-author with Sharpe could be worth mentioning. It could just be a distraction from the problems with what he actually wrote though.

 

[Valentijn]

Being a friend of someone is not a conflict of interest unless there is reason to expect financial or other gain.

It's a reason to promote bad research that they might otherwise question, and it also illustrates the incestuousness of British academics. At any rate, the readers and media outlets should get an honest accounting so they can decide themselves.

And substituting a real disclosure with a flippant "my wife had an office next to his" does make it look like his failure to mention it is deliberate.

 

[Jonathan Edwards]

I was unsure on that. I thought being a co-author with Sharpe could be worth mentioning. It could just be a distraction from the problems with what he actually wrote though.

I don' think there is a formal conflict of interest. However, considering that the two co-authored a paper the quip about his wife's office does seem to be an indication of contempt for the system - the sense of entitlement Marks was talking about. Above all the contempt for patients who write serious scientific critique.

 

[MEMum]

A couple of interesting items, re Professor Malcolm Macleod.
Firstly,an extract from his alumni profile:

"Alumni wisdom
The only way that things improve is when people challenge the way things are, our current beliefs and our current ways of doing things. You can make your challenge gently, or with all the force you can muster. Wisdom is knowing which approach to use when. I’m still learning."

Secondly his inaugural lecture, June 2014, titled "Rigour Mortis, How Bad Research is Killing Science"

I am still listening to this. He sounds like a medic with good understanding of obtaining valid evidence-based research. One of his comments is (before 20 mins); the two most important factors to minimise bias are randomisation and blinding.

He then shows results of scientific reviews from areas of neurology and concludes "you can see what happens when these elements that reduce bias are not taken into account" c 21 mins.

This is well worth listening to it and makes me wonder why on earth SMC thought he would be a good supporter of PACE. It all concentrates on bias and a distorted view of biological truth!

 

[adreno]

Sounds like another disgusting old fart hypocrite.

 

[MEMum]

He's not the same age as the rest of the old boy network.

This whole lecture is looking at problems of bias in biomedical science.
One comment was "publication bias is a double-edged sword, that moves in the direction of the interests of the people who are funding and promoting the research and it is something we all need to be aware of". This is close to, tho possibly not exactly his words.)

He also ends his lecture saying that a large part of biomed science over the last few decades could be considered as a tragedy or a farce, because of the levels of bias in the research.

I think, that if this guy was actually aware of the list of errors in PACE he would be appalled. Maybe (as many of us used to), he cannot believe that this level of incompetence could have got thro peer review and have lasted so long with its promoters being rewarded in multiple ways; and be full of as much garbage as it is.

Maybe if he was contacted by an eminent clinician/researcher he would take the time to evaluate the evidence for himself @Jonathan Edwards?

 

[Jonathan Edwards]

I think, that if this guy was actually aware of the list of errors in PACE he would be appalled. Maybe (as many of us used to), he cannot believe that this level of incompetence could have got thro peer review and have lasted so long with its promoters being rewarded in multiple ways; and be full of as much garbage as it is.

Maybe if he was contacted by an eminent clinician/researcher he would take the time to evaluate the evidence for himself @Jonathan Edwards?

Sorry to disappoint MEMum but I did contact him and he is all bright breezy on gunning for PACE which he knows every detail about and still thinks is the best evidence available. He came out with a whole lot of irrelevant stuff about how difficult it was to do studies, how it is better to have something to recommend rather than admitting you do not know what is best... It seems that his inaugural is just spin. It is easy to appear to be an energetic new broom sweeping things clear. Just read out what the textbook says on what not to do. Then go home and do it all over again. The lecture title makes me think of one the words used by James beginning with H.

 

[Jonathan Edwards]

I suppose it says a lot when someone gives their inaugural on how bad everybody else's science is. They don't need to say anything about their own.

 

[A.B.]

Sounds like another disgusting old fart hypocrite.

Just like Horton isn't it. Curates an image of the compassionate progressive seeking justice and well being for everyone, then he sides with the PACE authors and their callous exploitation of patients.

 

[Esther12]

how it is better to have something to recommend rather than admitting you do not know what is best...

AAArghghg!! Better for those who want to make money from claiming expertise over patients maybe? Shouldn't patients have a say over what is 'better' though?

Thanks for contacting him.

 

[Countrygirl]

Did you send it to him?

Malcolm.Macleod@ed.ac.uk

Yes, I rewrote it later and sent it via email (I was in a great rush this morning and haven't had access to my laptop during the day) and changed the order of the list of names. I placed the UK clinicians/researchers first.

I will let you know if I receive a reply.

 

[Countrygirl]

Sorry to disappoint MEMum but I did contact him and he is all bright breezy on gunning for PACE which he knows every detail about and still thinks is the best evidence available. He came out with a whole lot of irrelevant stuff about how difficult it was to do studies, how it is better to have something to recommend rather than admitting you do not know what is best... It seems that his inaugural is just spin. It is easy to appear to be an energetic new broom sweeping things clear. Just read out what the textbook says on what not to do. Then go home and do it all over again. The lecture title makes me think of one the words used by James beginning with H.

Ah! Won't expect much of a positive response to my email then.