Appeal to NICE concerning the Guideline Committee for ME/CFS

please signJohn Peters informs me: “Anyone can sign. The letter is going off with a couple of dozen signatures, but the petition is open to all.”

The petition is here. Please sign.

For many years, patients, charities and scientists have listed the deep flaws in studies promoting CBT and GET for ME/CFS, but NICE has accepted the research uncritically and a major part of its advice on the illness follows this approach. In the past a majority of the members of the Guideline Committee have had a conflict of interest.

In the USA, this research has been rejected by the Centers for Disease Control, the Food and Drug Administration, and the Agency for Healthcare Research and Quality. They and the National Institute of Health and the Institute of Medicine/National Academy do not consider CBT and GET to be effective.

There may be 250,000 patients with ME/CFS in the UK: NICE guidelines not only affect the way they are treated by the medical profession, but may be used by insurance companies and benefit agencies. These agencies may place inappropriate expectations on patients to undergo such therapies, despite a lack of evidence that they are safe, and in the case of GET, a strong response from patients that they can cause severe harm.

We call on NICE to ensure:

1. The process of deciding who determines the membership of the Guideline Committee is open and involves stakeholders.

2. Whoever appoints the members of the Guideline Committee does not have any involvement in research into CBT-GET or is currently using these interventions to try to treat ME/CFS or is a colleague of anyone associated with the CBT-GET model.

3. The selection of members of the Guideline Committee is also an open process and involves stakeholders.

4. No one who has previously been a member of an ME/CFS Guideline Committee is eligible to sit on this new committee.

5. No one with a conflict of interest is allowed to be a member of the Guideline Committee, and that conflict of interest includes any financial interest or researcher allegiance or close working association with someone linked to the CBT-GET model.

6. Stakeholders should have a right of appeal with cause against members selected.

Full letter sent to Sir Andrew Dillon: https://www.s4me.info/threads/grahams-finalised-letter-to-nice-january-2018.1885/

More information here: https://www.youtube.com/watch?v=7Y6XFipQigE&feature=youtu.be

On the previous NICE Guideline Committee: https://www.coyneoftherealm.com/blo…based-on-political-considerations-an-exchange

And: https://meagenda.wordpress.com/2008/12/19/a-nice-dilemma-by-margaret-williams-part-two/

Read the letter

When promoting cognitive behavior therapy for fibromyalgia is quackery

A probing of a story about fibromyalgia popping in my Facebook feed revealed incredible misleading claims and dips into quackery

My exploration of what becomes quackery begin with an unexpected item appearing in my Facebook newsfeed. It turned out to be coverage of an earlier  BBC news story on fibromyalgia:

Fibromyalgia to be recognised as long-term condition (BBC  21 September 2016) 

A selection of some bullet points from the accurate article based on the BBC News item:

  • Fibromyalgia is to be recognised by health professionals in Northern Ireland as a long-term condition.
  • People who suffer from it complain of aches all over the body, as well as profound fatigue.
  • Other symptoms include headaches, sleep deprivation and difficulty concentrating.
  • Despite the severity of symptoms, people living with the condition in NI have said their voices have gone unheard and their symptoms ignored.
  • Fibromyalgia is recognised as a condition by NHS Choices in England and Scotland, meaning treatments should be available to patients.
  • While there is no specific figure for Northern Ireland, it is thought around one in 25 may be coping with symptoms – a majority of them undiagnosed.

Readers who want to jump to an accurate US Center for Disease Control fact sheet to learn more about fibromyalgia can click here.

But the item was appearing in my Facebook news feed because someone who turned out to be lacking in accepted credentials  promoting her dubous treatment with dubious claims.

She said:

Despite what you may have come to be told or believe, Fibromyalgia is actually an emotional stress illness that manifests from suppressed and repressed emotions such as rage, anger, fear, worry, sadness, hurt etc. It is totally treatable and I have successfully treated many people through the Stress Illness Recovery Programme to full recovery. If you would like to find out more do not hesitate to contact me. You’ve nothing to lose except your pain.

I would subsequently uncover lots of information that led to a judgment she was a quack. But here is what alerted me to be skeptical.

She was trying to quell people’s skepticism by telling them “Despite what you may have heard or believe.”

Why should we suspend skepticism? What evidence is she offering that we should do so? 

She was also stating that fibromyalgia is actually emotional disorder caused by repressed and suppressed emotions. That ia a pseudoscientific claim lacking in evidence or credibility.

Talking about physical conditions as caused by repressed and suppressed emotion is a throwback to discredited 1950s  version of psychosomatic conditions. You can find my further discussion of this discredited framework here. 

But recognizable, conventional, evidence-based cognitive behavior therapy does not address “repressed and suppressed emotion.”  This is a throwback to the therapy  promoted by Hans Eysenck with fraudulent data that some of us have tried hard to get retracted from the journals were Eysenck managed to use his influence to get papers published.

She suggested that fibromyalgia is “totally treatable” to “full recovery”  through her stress illness recovery program. That claim is misleading to consumers and exploitative of them. The claim may even be actionable through advertising authorities.

After all, a manufacturer was required to pay $1 million dollars for making such claims about pillows and at least consumers got pillows for their money.

We should beware of anyone making claims about physical conditions being totally treatable to full recovery particularly with their personal brand of treatment that has not been independently evaluated.

Let’s just say that this practitioner has a penalty flag on the field, but we don’t dismiss her totally yet. We certainly have ample basis for rejecting what she is saying as exploitative nonsense and moving on.  But instead we click on the link that is provided and go to her website.

Louise Levy MA(Acrdt), DipCAH, DipCBH,HPD, PNLP, MNCH(Acc)  SQHP GHR, Adv DipLC, PG DipCG, SIRPA Adv, BTFT, DPLT

Wow! What an awe-inspiring set of letters after her name. Is one missing: BFD [Big Freaking Deal]? But what do any of them mean? And since when do we find qualified professionals having such a string? Compare to what qualified professionals list who are practicing in recognizably esteemed settings.

And then we get to her welcoming:

Welcome to my website, I hope you find it both informative and encouraging. A little about myself, I am a fully qualified and highly reputable Clinical Hypnotherapist, Cognitive Behavioural Hypno-Psychotherapist, Cognitive Behavioural Life Coach, Chronic Pain Specialist and Careers Guidance Counsellor located in XXXX. I have over 18 years intensive experience in supporting both young people and adults with a range of social/personal, work related, health and wellbeing concerns.

She describes herself as “qualified and highly reputable”. Proof? None of these titles are legally restricted: Anyone can use any of them without any licensing.

She says “cognitive behavioral” but it is attached to “hypnotherapist” and “life coach.” I suppose that allows her to escape criticisms that she is claiming to be a cognitive behavioral therapist, but that is not a restricted term either. Yup, you can claim you do CBT and get away with it in most places, because there is no legal restriction on that.

It’s a good idea when consumers find a string of seemingly familiar but not quite familiar titles like this, try Googling them.

The page has some links to dubious patient endorsements, all or them glowing, of course. We should be very suspicious of professionals who rely on patient endorsements. We don’t know what selection factor is there or even if they are from real patients. And who exploits patients by soliciting such endorsements for a promtional webpage? Not claiming a restricted title, this woman is not subject to codes of ethics, but most professionals would consider posting sucn endorsements to be tasteless, if not unethical.

Then we get to her credentials and the silliness of the ambiguous letters after her name that we encountered earlier becomes apparent. , I will stick her long list of dubious credentials at the end of this blog post where you can jump down to see what I’m talking about, but let’s step into these:

A Masters of Arts degree seems recognizable, but just where did she get it? If this degree is being listed as a credential, it is reasonable to ask “Where from?” and “in what field of study”?

At the end she has “BPS British Psychological Society (Level A).“ Hmm, we might recognize the organization, but it’s tough to figure out what Level A is. Best I can tell is that she is qualified to interpret psychological tests.

But some of these other qualifications are certifiably quackery. We won’t go through all of them, but scan through them and you see some howlers: “Advanced Weight Control and Hypnotic Stomach Gastric Banding” (!?)…

Or how about “DPLT Diploma In Past Life Therapy” (!?). Look that one up, she claims that she will improve your psychological well-being by addressing problems that occurred in your past lives that you don’t know about, but somehow she will know about and fix.

We can disagree on exactly where the line between unproved therapies and quackery lies. but still agree that this is quackery.

Then she provides a link to explain her expertise as a BTFT British Thought Field Therapist (Algorithm Level) :

What is TFT? TFT stands for Thought Field Therapy

It is a technique that brings about rapid relief from all kinds of emotional distress. It works rather like acupuncture but there are no needles involved and it is completely painless. The treatment involves simply tapping with the fingers on various parts of the face and upper body. This stimulates the body’s meridians to resolve internal problems, many of which may have long been held onto by the body. The technique is fast, effective and 100% safe.

This is a technique that I can quickly and easily teach you to use yourself. Emotional problems often reduce significantly in minutes.

Rapidly resolve emotional problems by tapping your finger on your face? Beam me up,  Scotty, this is scary stuff.

I blogged about  Thought Field therapy elsewhere  and quoted a recognized authority on psychotheray who described it as “either one of the greatest advances in psychotherapy or it is a hoax.” If you look at the time, you can go that blog post and some links and provides to find some absolutely extraordinary and implausible claims.

If someone had more time than I do, they could Google some of these other credentials, and they simply do not represent regulated titles, so you can have no assurance that there is any competence, any standards, or any evidence behind them.

I wouldn’t expect someone to pursue all these links as I have. Life is too short. But I hope to leave readers advised to when they encounter such extraordinary claims to simply run away, unless they have time to investigate them in the kind of detail that I have.

Cognitive behavior therapy for fibromyalgia: what do we know?

 A credible review in Nature Publications’ Journal of Rheumatology concludes:

 Bernardy K, Füber N, Köllner V, Häuser W. Efficacy of cognitive-behavioral therapies in fibromyalgia syndrome-a systematic review and metaanalysis of randomized controlled trials. The Journal of Rheumatology. 2010 Aug 3:jrheum-100104.

The current data indicate that CBT, as a single treatment modality, does not offer any distinct advantage over well-planned group programs of education or exercise, or both. Its role in the management of fibromyalgia patients needs further research.

Research on CBT to fibromyalgia typically consist of low-quality small trials. The CDC Fibromyalgia Fact Sheet does not recommend cognitive therapy for fibromyalgia, except has a treatment specifically for any comorbid major depression.

How did this awful stuff get into my Facebook newsfeed?

I certainly don’t follow Louise Levy, but I don’t have to to have this stuff inflicted on me. For a very small fee, people like Louise can promote their Facebook pages and get their new stuffed into the new feed. You can take it down, but you apparently you have to do it piece by piece.

Postscript: The qualifications of Louise Levy

If someone wants to Google soe of these qualifications and post the results in the thread of comments, be my guest. But the trick is to put in the whole credential, not just part if it, i,e., “Diploma In Advanced Weight Control and Hypnotic Stomach Gastric Banding”, not just “Weight control.”

MA Master Of Arts Degree (Acrt) in Guidance Counselling

DipCAH Diploma In Clinical Advanced Hypnotherapy H.E. Level 4

DipCBH Diploma In Cognitive Behavioural Hypno-Psychotherapy H.E. Level 4

HPD Hypnotherapy Practitioner Diploma The Gold Benchmark Standard H.E. Level 4

Master Practitioner In Smoking Cessation Hypnotherapy

Diploma In Advanced Weight Control and Hypnotic Stomach Gastric Banding

Master Practitioner In Working With Children (Specialist Childrens Hypnotherapist)

Master Practitioner in Cancer and Hypnotherapy

Specialist Certification In Emotional Trauma Regression

PNLP Practitioner Of Neuro Linguistic Programming

MNCH Member Of The National Council For Hypnotherapy(Acc)  Registered Senior Experienced

SQHP Senior Qualification In Hypnotherapy Practice GHR (General Hypnotherapy Register)

Adv DipLC Advanced Diploma In Cognitive Behavioural Life Coaching (Distinction)

PG DipCG Post Graduate Degree In Careers Guidance H.E Level 5

Chronic Pain / Stress Illness Advanced Specialist Practitioner (SIRPA)

BTFT British Thought Field Therapist (Algorithm Level)

DPLT Diploma In Past Life Therapy

Certificate in EMDR (Eye Movement De-sensitisation and Reprocessing)

BPS British Psychological Society (Level A)

 

 

 

PACE-Gate: The Making of a Medical Scandal

An advance look at the press release for a forthcoming Editorial for a Journal of Health Psychology Special Issue on the PACE trial-A Medical Scandal.

Kudos to David Marks for the courage to put together this historic special issue.

Kudos to Keith Geraghty for his editorial around which the special issue of commentaries is organized.

‘PACE-Gate’: When clinical trial evidence meets open data access

The journal and its editorial board faced stiff resistance from the investigators from the PACE trial of cognitive behavioural therapy and graded exercise therapy for chronic fatigue syndrome.

The investigators first demanded a full retraction of Geraghty’s article. When their demand was rejected, they then demanded  a partial retraction, with a correction calling attention to Geraghty failure to disclose a conflict of interest- he suffers from chronic fatigue syndrome 

journal of health psychologyThe following press release provides an excellent background for the PACE trial and the controversy in which it has become embroiled. I hope it will whet your appetite for the freely available special issue.

THE PACE TRIAL: THE MAKING OF A MEDICAL SCANDAL

David F. Marks, JHP Editor

A Special Issue of the Journal of Health Psychology on the PACE Trial, is to be published and freely available online on Monday 31 July 2017. It marks a special contribution of the Journal of Health Psychology to the literature concerning interventions to manage chronic health problems. The PACE trial debate illustrates what can happen when researchers become entrenched in a particular point of view, and fail to engage in constructive exchange with critics and stakeholders. It reveals an unwillingness of the Co-Principal Investigators of the trial to engage in authentic discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5million) on what is a textbook example of a poorly done trial.

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a controversial and poorly understood disease that blights the lives of over 250,000 people in the UK and at least 500,000 Americans. People with ME experience a dramatic decrease in their stamina for ordinary physical and cognitive activities, a characteristic dramatic increase in symptoms after minimal physical or cognitive exertion called post-exertional malaise, and a myriad of symptoms including sleep dysfunction, orthostatic intolerance and cognitive dysfunction as well as fatigue and pain. Normal activities like walking, showering, having a conversation or writing an email can leave people shattered for days or weeks or may simply be impossible. Most people with ME cannot work and 25% are confined to their homes or beds. The PACE Trial sought to test if two therapies, a talking therapy called ‘Cognitive Behavioural Therapy’ (CBT) and exercise in the form of ‘Graded Exercise Therapy’ (GET), might help.

The Trial attracted unprecedented criticism, not only because it cost taxpayers an extraordinary sum (almost £5 million) but the trial itself was deeply flawed. The results are, at best, unreliable, and, at worst, manipulated to produce a positive-looking result. Patient groups have cried foul because they believe they are being sold a lie that talk therapy and exercise can cure ME/CFS when in fact many experience actual harm.

The PACE Trial was led by Professor Peter White of Queen Mary University London (retired), Professor Michael Sharpe of Oxford University and Professor Trudie Chalder of Kings College London. They published their results in the Lancet in 2011 with the contentious claim that CBT and GET cured 22% of patients while over 60% improved. The patient community reacted with scepticism and after a long battle with the PACE authors, a patient from Australia, Mr Alem Matthees, won a Freedom of Information Tribunal case to gain access to a small sub-set of the PACE trial data.

It was discovered that the PACE authors had altered the way in which they measured improvement and recovery to increase the apparent benefit of the therapies.  Reanalysis by Wilshire and colleagues in 2016 in the Journal of Fatigue showed that the improvement rate fell from 60% to 21% and the recovery rate fell from 22% to just 7% when using the original study protocol. The genie was out of the bottle.

In 2016 the Journal of Health Psychology published an Editorial by Dr. Keith Geraghty of the University of Manchester entitled ‘PACE-GATE’.  Geraghty suggested that the PACE authors had altered their procedures to make CBT and GET look more beneficial. The PACE trial team reacted with anger and submitted a cursory reply. A host of experts on both sides of the debate were invited by JHP Editor Dr David F Marks to write Commentaries on the PACE Trial. All Commentaries were peer-reviewed. The majority agreed that the PACE Trial was flawed, that the PACE authors had altered their methods, breaking a fundamental principle of clinical trials, and that results from the trial were unreliable.

It also highlighted that the PACE Co-Principal Investigators had conflicts of interest by acting as consultants to large insurance companies and Professor White had also worked as an advisor to the Department of Work and Pensions, a main funder of the PACE trial, with a special interest in reducing social security benefits to disabled ME/CFS claimants.

Despite many serious concerns about the PACE Trial, the trial continues to be used by UK Governmental agencies, the NHS and the National Institute for Clinical Care Excellence  (NICE) as part of the evidence-base  to recommend CBT and GET to sufferers of ME/CFS. The current review by NICE of these treatments presents an opportunity to bring clinical practice properly in line with scientific evidence.

FOR FURTHER INFORMATION, PLEASE CONTACT:

UK & IRELAND:

Dr Keith Geraghty, JHP Editorial & Contributor: Department of Health Services Research and Population Health, University of Manchester; email: keith.geraghty@manchester.ac.uk; Twitter: @keithgeraghty 

Professor Keith R. Laws, JHP  Contributor: email k.laws@herts.ac.uk

Dr Ellen Goudsmit, JHP Editorial Board Member & Contributor: +44 (0) 20 8977 2386 (from 8am to 9 pm); ellengoudsmit@hotmail.com

Professor Jonathan Edwards, JHP Contributor: +44 (0)7340015831; jo.edwards@ucl.ac.uk

Dr Charles Shepherd, JHP Contributor & Medical Adviser at the MEA:  +44 (0) 1453 885462

Karen D Kirke, JHP Contributor: karen.d.kirke@gmail.com  – especially regarding patient experience of ME/CFS and patient feedback on GET and CBT.

United States:

Professor James Coyne, JHP Senior Associate Editor: jcoynester@gmail.com Twitter: @CoyneoftheRealm 

Professor Steven Lubet, JHP Contributor: Williams Memorial Professor,  Northwestern Pritzker School of Law, 357 E. Chicago Avenue, Chicago IL 60611: +1 312.503.6605 (tel); +1 312.503.8977 (fax); slubet@law.northwestern.edu

Professor Leonard A. Jason, JHP Contributor: Director, Center for Community Research, DePaul University, Chicago, Il. 60614: +1 773-325-2018; Website: https://leonardjason.wordpress.com/; LJASON@depaul.edu.

Europe:

Dr David F Marks, JHP  Editor:

FROM WHOM PRE-PUBLICATION COPIES OF THE SPECIAL ISSUE MAY BE OBTAINED.

Email: editorjhp@gmail.com; Twitter: @newhealthpsych

 

Misconduct in an author’s nomination of reviewers for his manuscript

An author, Kjell Gundro Brurberg  appealed the rejection of his manuscript. He was offered an opportunity to nominate additional reviewers, but to ensure they did not have conflicts of interest. What happened next…

kjetilKjell Gundro Brurberg happens to be an author on a controversial Cochrane review about which there are serious concerns about conflict of interest and coordinated outcome switching across trials.

He is also an author on a forthcoming Cochrane review for which Cochrane refuses to share data for independent reanalysis. This  whole incident adds the importance of Cochrane releasing the data from that review for independent reanalysis, which the organization is currently refusing to do.

Now Brurberg is misrepresenting what happened in a blog post at Mental Elf, a blog site that has consistently shown itself to not vet what is posted by bloggers.

I will document in this issue of Quick Thoughts what really transpired. But his blog post indicates that Brunberg just doesn’t get how he blew an opportunity to publish his manuscript with his bad behavior.

Giving authors the opportunity to nominate reviewers has benefits to both the authors and to editors, but it depends on trust and the option can be abused by authors.

The whole story is part of a larger narrative of how hard it is to obtain an independent critique of the PACE trial of cognitive behaviour therapy and graded exercise for chronic fatigue syndrome.

I know from experience as a Senior Consulting Editor at the Journal of Health Psychology. Under Editor-in-Chief David Marks, the journal accepted an editorial commentary critical of the PACE trial and invited responses from a variety of perspectives.  The journal has endured repeated assaults on its editorial independence and integrity since.

hypocrisyHere is my updated account of the PACE investigators’ pressures on Journal of Health Psychology to retract portions of the published commentary and to issue a correction acknowledging the author had an undeclared conflict of interest. Ah, the kettle calling the pot black.

But before we delve into the details of the current incident, let’s discuss the practice of allowing authors to nominate reviewers.

Background: Authors being allowed to nominate reviewers

Authors can be instructed not to nominate reviewers with obvious conflicts of interest or indications of being unlikely to provide an unbiased review. Even, better editors can ask authors to indicate explicitly that the reviewers they have nominated are free of conflict of interest. Authors declaring there is no conflict when there is an obvious conflict of interest can be seen as tantamount to scientific misconduct.

Until recently, authors were routinely asked to nominate reviewers for their manuscripts. What had been a common practice became controversial and was outright stopped at many journals when a major scandal in peer review occurred in 2013- 2015.

In what turned out to be only the first wave of continually uncovered problems with a number of journals, Springer and BMC (which Springer now owns) undertook an investigation and retracted 50+ papers for peer review manipulation and other issues. Commenting to Retraction Watch, one publisher said:

Alongside investigation into the identified papers, we have taken action to ensure that no further compromised papers can continue through to publication. BioMed Central has changed our policy on suggesting peer reviewers so that authors may do so in a cover letter with evidence of the peer reviewers’ authenticity.

Once the crisis went public, at least one journal continued to ask authors to recommend reviewers, but then made sure that that papers didn’t go out to any reviewers whom the authors had nominated. Ouch!

The crisis had seemed to ease, but a new record was recently set with a major publisher retracting more than 100 studies from a cancer journal over fake peer reviews. 

Not surprisingly, there is evidence that reviewers who are recommended by authors are more likely to give positive reviews.

Our results agree with those from other studies that editor-suggested reviewers rated manuscripts between 30% and 42% less favorably than author-suggested reviewers. Against this backdrop journal editors should consider either doing without the use of author-suggested reviewers or, if they are used, bringing in more than one editor-suggested reviewer for the review process (so that the review by author-suggested reviewers can be put in perspective).

Obviously, editors need to be diligent and skeptically probe author-nominated reviewers. But relying on some of these nominations can be helpful if an editor, particularly if nominations are screened and provide only a portion of the reviewers for a manuscript. Flagging that a particular reviewer was nominated by an author is also helpful in the editor’s interpreting discrepancies in a set of reviewer recommendations for publication.

Presumably reviewers recommended by authors will be familiar enough with the topic of a manuscript to accept a request to review and provide in a timely fashion.

Authors may actually be best qualified to identify reviewers for their particular areas of research, even if editors have to evaluate the potential for bias and conflict of interest.

Though I’m most comfortable handling manuscripts in my areas of research, I am serving as academic editor for a megajournal with a broad interdisciplinary focus. I can’t expect to be on top of every nook and cranny of every subfield.

I also may not be as familiar as authors are with the up and coming researchers in a particular area of research who do not yet have a large number of publications, but who have an impressive brand new or “early view” paper or two out.

Relying on some reviewers nominated by authors can also help the balance the Anglocentric –and in some fields –older male bias of editorial boards.

Sure, there are problems with relying too heavily on reviewers that authors suggest, but let’s not get too misty eyed nostalgic about peer review in the old days when editors tended to rely just on people that they only personally knew.

There was a lot of old boy cliques looking after each other that could be the formidable obstacles if you wanted to challenge dominant theories. Some specialized journals were dominated by senior investigators who kept out threats to their theories or particular findings.

That is certainly still a problem in particular areas of research, but with more democratization of peer review and transparency, it gets a bit easier to uncover and challenge old boy cliques.

But unless publishers provide user-friendly tools to evaluate suggestions or can hire private investigators, editors have to rely to considerable extent on simple searches of published papers and trusting the report of authors to evaluate whether reviewers are appropriate and that they have no conflict of interest. Instructing authors ahead of time that nominations have to be free of conflict of interest is important.

I once was suspicious of an author nomination in an appeal of a rejected manuscript in a highly contested area of research. Google Scholar revealed no shared publications, but a broader internet search quickly yielded wedding pictures with the reviewer as the author’s best man.

This brings us to a recent problem we faced at the Journal of Health Psychology. The Senior Editor, David Marks, rejected a manuscript based on a rather thorough negative review. The author appealed this decision and was offered the opportunity to nominate additional reviews. However, because the manuscript concerned the contentious issue of the PACE trial, the author was given the responsibility to pre-screen his nominations for reviewers and indicate in writing that there were no relevant conflicts of interest.

The letter to the author rejecting his nominations because he misrepresented the conflicts of interest of reviewers

Dear Dr. Brurberg:

I write you in regards to manuscript # JHP-17-0254 entitled “A PACE-gate or an editorial without perspectives” which you submitted to the Journal of Health Psychology within an appeal procedure. Your manuscript is rejected due to your misrepresentation of conflicts of interests.

I have sought advice from my Associate Editors and this email is therefore copied to two of them.

I was going to wait until the end of the month before letting you have a decision, but new information came to light about Dr. Y that makes further delay unnecessary. The three reviewers that you recommended were supposed to be neutral, independent experts with no known conflicts of interest.   Unfortunately, however, one declined the invitation to review (X) and the other two (Y and Z) have objectively proven conflicts of interest.

In light of your appeal, you were given the generous opportunity to have your manuscript re-reviewed by one or more impartial experts chosen by you. It is highly disappointing and curiously naive that you have attempted to subvert the appeal process by recommending people who are strongly conflicted, in one case (Dr. X) by his own admission is an associate of the PACE investigators. You stated that Prof X is: “Interested in medically unexplained diseases. Holds the needed distance to the ongoing PACE debate.” The latter could not be further from the truth. In his email on 26 April 2017 Prof X stated:

“Good evening.

Bit of a curve ball this one I suspect!

Having been trolled briefly by [ the author on whose paper a comment was submitted] a while ago I might have a personal axe to grind, and having been supervised by Michael Sharpe (who may or may not have anything to do with this manuscript) between 5 and 10 years ago I would probably be regarded as irrevocably conflicted by the anti-PACE-ists. Mind you, I’ve also sat next to Peter White at a couple of (enjoyable) conference dinners – even that probably renders me tainted to some eyes.

Anyway, I’m perfectly prepared to be grown-up, reflectively self-aware, and as neutral as possible, in carrying out a review for you. But if you do open peer review you will probably be trolled for asking me.

If you still wish me to review, then please just let me know. But I thought I would give you a more than usually full COI summary first!

-X

Hardly, a description of a reviewer who is likely to be independent and unconflicted.

In the second case, Dr. Y, has a clear COI by association with pro-PACE researchers through joint work and publication. You stated that Y has: “Expertise in exercise therapy and CBT. No COI with regard to commentary authors.” Yet I discovered on Google Scholar that Y was actually a visiting staff member of the School of Psychology at the University of Southampton. The working visit was made possible by a grant from the Dutch MS Research Foundation (Stichting MS Research). The original RCT was funded by a grant awarded to R. Moss-Morris by the New Zealand Neurological Foundation.” I am sure you don’t need me to tell you that Prof Moss-Morris is closely connected to the so-called ‘Biopsychosocial Model’/’Dysfunctional Beliefs Model’ of ME/CFS advocated by the PACE Trial team. This fact is evidenced by:

[A specific publication co-authored by someone central to the PACE controversy removed because it identifies the proposed reviewer.]

It is important to consider, in addition, your own conflicts of interest as a person who worked for the Cochrane Collaboration in the analysis of individual data on exercise therapy for CFS including data from the PACE Trial and from studies by Moss-Morris (2005) (already mentioned above). The relevant reference is:

Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews 2015, Issue 2. Art. No.: CD003200. DOI: 10.1002/14651858.CD003200.pub3.

It is not often in my experience that an author misrepresents the facts about his/her recommended reviewers in such an audacious and palpable manner. If you lie these days, exposure is only a few clicks away. Norway is a small country, a country that I dearly love, not a place I normally associate with cheats and rogues. That impression just took a nose-dive. You have wasted a lot of my time and you won’t be given a 3rd or 4th chance. You have already blown it.

I recommend that you reflect on the ethics and professionalism of your actions and the potentially serious consequences for your professional career. Better luck next time! But please don’t try it on again with this journal.

Regards,

David F Marks PhD

Editor

Journal of Health Psychology

editorjhp@gmail.com

The authors’ response

On 26 June 2017 at 09:02, Brurberg, Kjetil Gundro <KjetilGundro.Brurberg@fhi.no> wrote:

Thank you,

You are right, this is completely my fault. It is obvious that I should have known that your ‘journal’ only accept reviewers who disregard the PACE-trial as well as the PACE-researchers. It would have helped me, though, if you had stated this policy when you first invited me to write this comment.

Best regards

Kjetil G. Brurberg

Postscript

 Some past posts relevant to complaints about the bias of the Cochrane review and my efforts to obtain the data from it for independent re-analysis. Unfortunately, despite advocating that others share data for independent reanalysis, Cochrane refuses to share.

 Why I am formally requesting the data set from a Cochrane review (April 13, 2017)

Conflicts of interest in Cochrane reports on psychological interventions January 15, 2017

 

Probing an untrustworthy Cochrane review of exercise for “chronic fatigue syndrome” April 23, 2016

 My response to an invitation to improve the Cochrane Collaboration by challenging its policies April 21, 2016

An open letter to the Cochrane Collaboration: Bill Silverman lies a-moldering in his grave March 6, 2016

 

 

Asserting privilege: PACE investigators’ request that their manuscript not be peer reviewed or receive replies

rabbits and knights

From the Art of Anna-Maria Jung http://www.annamariajung.com/

After demanding parts of an article published in the Journal of Health Psychology be retracted, the PACE investigators requested their response be published without peer review and with no comments allowed.

This episode is part of a continuing saga of the PACE investigators attempts to exert extraordinary control over what is said about their work.

The predicament of the scientific community with respect to the PACE trial fits well with John Ioannidis  has termed scientific inbreeding where an interconnected group is able, temporarily at least, to dominate a scientific area and control and contain criticism of flaws consistently characterizing their work. We may well be witnessing a break in that control and the beginning of a decline effect, where independent critique and re-analysis of data make those flaws more inescapably obvious.

The emails that will be reproduced below came after the PACE investigators lobbied some members of editorial board and asked them to demand the article be retracted and to threaten resignation if it were not retracted.

As I previously described, when I reviewed their submission  , the PACE investigators refused to revise their manuscript. Instead, they threatened to complain to the Committee for Publication Ethics because my public criticism of them should have established that I had a conflict of interest in reviewing the paper.

journal of health psychologyBefore that, the PACE investigators requested partial retraction of a commentary by Keith Geraghty in  Journal of Health Psychology. They said he must remove claims and language that offended the PACE investigators. The PACE investigators further demanded that the journal issue a correction to the article that acknowledged that Geraghty had not revealed that he suffered from chronic fatigue syndrome. This, the PACE investigators, constituted an undeclared conflict of interest.

The article to which the PACE investigators were objecting is:

Geraghty KJ. ‘PACE-Gate’: When clinical trial evidence meets open data access. Journal of Health Psychology DOI: HTTPS://DOI.ORG/10.1177/1359105316675213

The email to the Editor of Journal of Health Psychology

Dear Dr Marks,

Thank you for your quick response. We appreciate your offer of a published response, but suggest that a response to a published article would normally be reviewed by an editor, rather than going to blind review. This would also speed up publication, and quick publication of our response is essential. We would also appreciate your reassurance that our response will be electronically linked to the Geraghty article.

You say that Dr Geraghty used moderate language, but we would respectfully disagree. Saying something appears to be so implies that one believes it is so. Dr Geraghty questioned the integrity of the PACE trial team, and did so without any evidence. For example, where is the evidence that we neglected or bypassed  “accepted scientific procedures and standards”, when the trial was peer reviewed for funding, ethically approved, independently overseen, and published after peer review in a high impact journal? Whilst we are less concerned by the number of simple errors in this piece – although surprised that they passed peer review – we suggest that the personal and arguably defamatory (how else would one describe “bypassing accepted scientific procedures and standards”?) comments made in this article should have no place in a scientific journal. We therefore again ask you to revise the article to remove all these comments.

Yours sincerely

Professors White, Chalder and Sharpe

On behalf of the PACE trial team

Then, the Principal Investigator objected that others would be allowed to publish a commentary on their paper. Actually, in communications with the journal can elect for there to be comments. Three times, White and the PACE investigators (at submission, resubmission, and final approval of the proofs), the group had endorsed commentaries, but now White was asserting that they had done so in error.

From: PD White <p.d.white@qmul.ac.uk>

Date: 21 December 2016 at 12:04

Subject: RE: Journal of Health Psychology – Decision on Manuscript ID JHP-16-0873.R1

To: David F Marks <editorjhp@gmail.com>

Dear Dr Marks,

 

I am surprised that you have asked for commentaries on our editorial response to Dr Geraghty’s editorial, and now ask you to reconsider this.

I pressed the “open peer commentary” button in error, thinking our response was a “commentary” on the original editorial. As I wrote yesterday, it should be considered an editorial, consistent with your promise to publish our response alongside Dr Geraghty’s editorial, and linked to it. If you publish commentaries about our editorial, these would be comments on our commentary on a commentary on our original work. When would this iterative process end? If the new commentaries mention new criticisms, we would want a right of reply to those criticisms.

Thank you for reconsidering this.

Yours sincerely,

Professor White

Postscript

The PACE investigators were offered a chance to reply to the responses that their article elicited. Despite requesting that option in the email above, they have now indicated that they will not respond. But of course, they may change their mind has they have done have in the past.

There are more posts to follow about how demanding and threatening the PACE investigators have been. They are obviously used to getting their way. We can’t readily determine the true extent to which journals have caved to them or when critics have been silenced, beyond what gets reported in social media.

In discussing inbred scientific groups, John Ioannidis has described an obliged replication, whereby proponents of “a particular approach are so strong in shaping the literature and controlling the publication venues that they can largely select and mold the results, wording, interpretation of studies eventually published.” However, the occasion of Ioannidis’ comments was the publication of both a n.on-replication in a critique of type D personality by my colleagues and myself. Type D personality had been a dominant perspective in psychosomatic medicine. However, we can now see that our  two papers marked a distinct beginning to the rapid decline that followed rapidly. Perhaps the publication of the string of commentaries in Journal of Health Psychology will have the same effect on the biopsychosocial model and cognitive behavior therapy and graded exercise therapy for chronic fatigue syndrome.

Related posts

My peer review of a PACE investigators’ article that the authors refused to heed

Should authors declare a conflict of interest because they suffer from the illness they are writing about? 

PfferYou can see other art of  Anna Maria Jung at http://www.annamariajung.com/ where it is available as  prints, shirts, mugs and much more. She is also offering “The Pepper Chronicles,” a kick-ass, 200 pages graphic novel full of adventure, action and filthy jokes – that was released in German this June. 

Global expert on distant and faith healing chaired PACE Data Monitoring and Ethics Committee

mild distance-healing1Paul Dieppe, the initial Chair of Data Monitoring and Ethics Committee for the PACE trial is also renowned as a “leading global voice in the understanding and advancement of energy/ spiritual healing.”

Most of my medical colleagues think I’ve gone completely barmy –  Paul Dieppe

Renowned as a leading global voice in the understanding and advancement of energy/ spiritual healing

Paul Dieppe, the Chair of Data Monitoring and Ethics Committee of the PACE trial of cognitive behavior therapy and graded exercise therapy for chronic fatigue syndrome has had a distinguished career, up to a point. He has emeritus status at the University of Exeter Medical School and is described on the website:

Paul qualified as a doctor in London in 1970. He specialised in rheumatology and became ARC professor of rheumatology in Bristol in 1987, and Dean of the Bristol Faculty of Medicine between 1994 and 1997. He then switched to health services research and was the Director of the MRC Health Services Research Collaboration between 1997 and 2007. After that he spent a short time at the University of Oxford before moving to the Peninsula Medical School to work in clinical education research.

With the formation of the University of Exeter Medical School, he took on the role of Professor of Health and Wellbeing.

Yet a more recent (2016) website gives a different picture of him:

exeter professor discovers

And gives a chance for  Dieppe to describe himself:

Paul, now renowned as a leading global voice in the understanding and advancement of energy/ spiritual healing, said: “My goal is to work towards the greater understanding that we can bridge the gap between biomedical thinking and the world of unexplained phenomena around areas such as healing, which if we placed greater value upon, could play a crucial role in the wellbeing of society.”

A further advertisement for the conference at which Dieppe spoke stated that there would be live demonstrations of healing on stage and describes his talk as:

The incredible power of remote healing across distance:  Paul Dieppe, emeritus professor of health and wellbeing, renowned for being at the global forefront of research into Healing.

faith healer in NHSA press release for “the largest meta-analysis of ever undertaken into the effects of non-contact healing”  states:

In fact, there are many healing practices where healer(s) and the one needing healing never come in contact with one another.  Indeed, they may never even meet, let alone know each other.

Paul Dieppe is identified as a Trustee of the group that produced a meta-analysis and he comments on the findings:

“This is a rigorous, high quality scientific report, and it clearly shows that healing intention can have beneficial effects on living systems, both human and non-human. Now we need to explore questions such as who does it work for and in what circumstances, as well as the how and why questions.”

A 2015 interview shows him rejecting scientific methodology as old fashioned materialism. Instead as he favors  anecdotes  and embraces energy/spiritual healing.

Have you come across many instances of actual healing?

Masses of cases. It’s anecdotal stuff, but it’s extremely impressive and extremely convincing. I’ve experienced it myself. A lot of this stuff happens completely under the radar, people just getting on with it in their back room, not part of any particular body or group, just doing their own thing. I went to see one such person, a little old lady in her front-room, and she said the best way to understand healing is to experience it yourself, and asked if I had anything I wanted working on. I told her I had a bad knee, so she said, OK let’s give it a go. And for what it’s worth, it’s been better since then. That was a couple of years ago.

Do you have a sense of what happens in the brain, does it involves specific neural or nervous networks? What systems does it involve?

Life gets difficult when you talk like that. You’ve slipped into the assumption that our materialist knowledge is the appropriate framework for that. We assume our current materialist science can explain everything, so the default position is ‘how can I explain this physiologically within my own materialist framework?’ I’m not convinced that’s the right way to do it.

No, I don’t have a materialist worldview, but if there is a spiritual dimension (which I think there is) I’m curious as to how it interacts with the body. William James, for example, explored how spiritual experiences interacted with ‘the subliminal self’. I wonder if healing is connected to things like trance states, altered states of consciousness, and so on.

OK, well how might it happen in those terms? Certainly there’s a lot of evidence for our ability to alter things through the Autonomic Nervous System via hypnosis. That can give us clues to a lot of this stuff. Hypnosis certainly affects the ANS, it certainly affects the immune system…probably everything. The mind / body split is of course silly. Everything is connected, everything works together. Although it’s easiest to talk in terms of what we can observe physiologically…I think we can control pretty much all of it probably.

OK, so at the moment we’re at or near the peak of a biomedical conception of health and illness. You, by contrast, espouse what you describe as ‘a bio-psycho-socio-spiritual theory of the transcendence of suffering’. How does that go down in academic medical circles?

Most of my medical colleagues think I’ve gone completely barmy, and this is all absolute nonsense. The dominant model in which we work and teach rejects anything to do with spirituality. If you mention words like spirituality or love, you’re rejected. It’s not acceptable behaviour, you’re regarded as someone who should be quietly taken off to the funny farm. So it’s quite lonely. It doesn’t bother me, I’m at the end of my career, I don’t need a new job or a reference, I don’t need to toe the line. It’s irrelevant to me. But I can feel the group discomfort sometimes around this area. I think the medical profession is a bit out of kilter with the rest of society, which is probably more accepting of the link between spirituality and health.

The interview links to a video featuring Dieppe on a trip to Lourdes, a destination for millions seeking miraculous cures.

The Role of the Data Monitoring and Ethics Committee in a Clinical Trial

As chair of the PACE DMECT, Paul Dieppe was in a unique and powerful position, able to monitor incoming data that was unblinded with respect to the group to which participants were assigned.

A recent Medical Research Council document states

6.2 DATA MONITORING COMMITTEE

The role of the Data Monitoring Committee (DMC) is to monitor the data emerging from the trial, in particular as they relate to the safety of participants, and to advise the Trial Steering Committee on whether there are any reasons for the trial not to continue. It is the only body involved in the trial that has access to the unblinded (unmasked) comparative data during the trial.

At the time of the fateful shifting of scoring of subjective outcomes and downgrading of the status of objective outcomes, Dieppe more than anyone else was in a position to know how switching would effect results of the analyses of the data already collected. He supposedly reviewed analyses in closed meetings, excluding Principal Investigator Peter White, but he was also meeting White formally and informally.

distasnce healingDieppe knew exactly what was going on in the most recent data, in terms of emerging  patterns of group differences. He would also have attended the meetings in which changes to the protocol were discussed and approved. Did he remain quiet? Refuse to meet with White in private? Maybe Dieppe relied on the unspoken interconnected consciousness of the two men.

We have a mystery akin to that about what when on before the US elections between Trump and his advisers, on one hand,  and the Russians.

The significance of a science-skeptic heading the PACE DMET

 Even before Dieppe’s colleagues would have described him, as he puts it, going completely barmy, he was a believer in the extreme, almost mystical power of the placebo. Perhaps that made him an ideal choice to head the DMET for a trial that created such an imbalance in nonspecific effects between the active treatments and the comparison group. And then boosted the imbalance as part of treatment and even in a newsletter (!).

But seriously, what we make of someone having such disdain for scientific methodology having the responsibility for ensuring its rigor in a major clinical trial?

 

 

 

 

NICE guidelines are discrepant with meta analyses and based on political considerations: An exchange

NICE

 

In a recent blog post, Go ahead, former  member of the Journal of Health Psychology editorial board, make my day, I made a passing comment about NICE guidelines

“As been demonstrated with numerous conditions, NICE guidelines often are based on political considerations and are discrepant with the results of meta-analyses and other best evidence.”

The comment elicited a reaction from Professor Paul Salkovskis1 of Bath University.

I posted the comment. I indicated I would respond, but that I would welcome others responding in the interim.

I am actually ended up being quite comfortable with others’ responses and their rich links – Professor Keith Laws and pseudonymous blogger JohntheJack (AKA John Peters).

I feel it would be useful to elevate the exchange from the obscurity of a thread of comments to a full plug post.

Without further ado:

Paul Salkovskis (1)

Hi Jim. Can I ask for clarification of your concerns regarding NICE guidelines? I have been involved in various ways and find one of the key strengths of NICE is its relative freedom and safeguards from political and commercial interests. There is also an important element of service user and PPI input, full publication of the evidence considered and so on. I have seen guidelines conflicting with those of others but as far as I can tell that’s related to relative rigour. It may be that you have strong evidence that I do not for this assertion?

Paul Salkovskis

PS CoI statement: I have participated in NICE work; in common with other participants I have not been paid or received other reward for this work on behalf of the NHS.

I replied:

Thanks. Paul for raising an important question. I will be providing an answer tomorrow, but I thought my readers should not wait for an opportunity to view your post. Some of my readers might want to respond in the interim or maybe after they have seen both our posts.

Best

Professor Keith Laws (2) responded:

The points made here by Jim seem self-evident (at least to me). I can think of at least three NICE guidelines where the above statements are true. In this context the guide on CFS/ME (CG 53) makes claims that are un-evidenced. For example, the claim that CBT reduces distress in CFS/ME – they make the claim with no support whatsoever…indeed some evidence suggests that some psychological interventions may worsen distress in CFS/ME http://journals.sagepub.com/doi/full/10.1177/1359105317710246

It is also clear that in CG53 that they take great pains to dismiss the views of ‘service users’- again see the above short paper, while failing to apply the same gaze on the evidence they propose in favour of CBT.

NICE also present unevidenced claims in the guides for schizophrenia and the guide for bipolar disorder. Here is a Guardian piece I wrote on the NICE Bipolar guide (CG185) relating to our paper in the Lancet Psychiatry https://www.theguardian.com/science/sifting-the-evidence/2016/feb/05/nice-guidelines-for-psychological-therapy-cbt-overstepping-evidence

It is clear the authors of the guide are biased – excluding the largest ever trial and unable to explain why – even in their response to us. Indeed, they NICE have no evidence that CBT reduces mania or -remarkably- even depression (in bipolar patients) …in the short-term or the long-term

Finally NICE are show bias in their advocacy of CBT for schizophrenia/psychosis in CG178- something I wrote on it for the Conversation https://theconversation.com/are-treatment-guidelines-on-schizophrenia-and-bipolar-disorder-just-plain-wrong-54369
NICE CG178 has even been publicly described in the British Journal of Psychiatry by the former SIGN chair (Mark Taylor) responsible for schizophrenia treatment guidance in Scotland as promoting “some psychosocial interventions, especially CBT, beyond the evidence…[and] also make some strong recommendations based on no evidence at all”. http://bjp.rcpsych.org/content/206/5/357.full-text.pdf+html

Yet all three guides promote CBT (despite the lack of evidence. In some cases,NICE committee members advocate CBT as an ‘alternative’ to medication (when not one relevant study exists); nevermind the poverty of evidence in combination with medication. The same guideline had also advocated using CBT to increase insight and to promote medication adherence – when not one study supported either…and then a few years later, they removed both from the guideline (again with no evidence) – this is the whim of the committee…depending upon the way the political wind blows! We might also ask why has the meta-analytic evidence in the schizophrenia guide not been updated with RCTs since 2008? …perhaps the ‘evidence-wind’ has blown in a different direction…and political expediency is to change nothing. So , I would say plenty of evidence shows political bias in NICE decision -making regarding CBT advocacy at least in the three areas that I have examined)

JohntheJack (3) weighed in:

It is interesting that Keith Laws uses ‘self-evident’ as it was a term I was going to use.

I don’t question Psychonoclast’s experience. I’m sure there are times when the system works well. I think there are bound to be problems when a false consensus has taken root, as with ME, or when proponents of a certain view have captured the process, as in Professor Law’s examples.

The answers are always going to depend on who is asked to provide them.

The current NICE guidelines for ME were set out in 2007. They were endorsed in a review commenced in 2010. They use the broadest possible criteria for the illness and recommend CBT and GET as effective treatment.

The committee which decided on these guidelines is available here
https://www.nice.org.uk/guidance/cg53/documents/guideline-development-group-members2

I’m not sure how these committees are drawn up, but I think it’s noteworthy that members include a psychiatrist, a psychologist,a physiotherapist, a dietitian and an occupational therapist. I wonder if the same sort of people would be involved in a committee on, for example, encephalitis.

What I think does throw doubt on the whole process is the conflict of interest of many of those involved.

There is an update on conflicts of interest here. There is presumably an earlier document, but this list in itself is revealing.
https://www.nice.org.uk/guidance/CG53/documents/chronic-fatigue-syndrome-myalgic-encephalomyelitis-gdg-members-declaration-of-interests2

The PACE trial was ongoing when these guidelines were drawn up. The review, started in 2010, claimed the 2007 findings were ‘supported by the recently published PACE trial comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome’.
https://www.nice.org.uk/guidance/cg53/documents/chronic-fatigue-syndrome-myalgic-encephalomyelitis-review-decision2

A comprehensive look at the committee was done in 2008 by Margaret Williams.

https://meagenda.wordpress.com/2008/12/19/a-nice-dilemma-by-margaret-williams-part-two/

and

https://meagenda.wordpress.com/2008/12/19/a-nice-dilemma-by-margaret-williams-part-three/

Almost all the members of the committee were linked in some way with a particular view of ME.

Bavinton after her work in PACE is now in private practice offering GET for ME.
http://vitality360.co.uk/fatigue-pain/about-us-2/about-us/our-team/

Crawley had not long been working in the field in 2007. She recently described Peter White, one of the main proponents of CBT-GET and principal investigator for the PACE trial, as important to her career.
https://soundcloud.com/university-of-bristol/fatigue-and-me-a-story-of-research-in-a-controversial-area
She has developed a paediatric centre for ME. She continues to use very broad criteria and to use CBT-GET. Her most recent research has included a study of the quack Lightning Process
https://www.coyneoftherealm.com/blogs/news/bristol-uni-refuses-to-disclose-how-much-money-paid-for-quack-therapy-in-smile-clinical-trial
and one on GET.
http://bmjopen.bmj.com/content/6/7/e011255.full?sid=507feb97-e40e-4693-a7ce-74ef3a62f240

‘Minister, two basic rules of government: Never look into anything you don’t have to. And never set up an inquiry unless you know in advance what its findings will be.’

Cast of Characters

(1) Paul Salkovskis [] is Professor of Clinical Psychology and Applied Science. In 2010 he was appointed Programme Director for the Clinical Psychology Doctorate Programme at Bath. Previously he was Professor of Clinical Psychology and Applied Science and Clinical Director in the Centre for Anxiety Disorders and Trauma at the Institute of Psychiatry (2000-2010)

(2) Keith Laws is Professor of neuropsychology at the School of Psychology at the University of Hertfordshire.[1] Professor Laws’ research centers on cognitive functioning in people suffering from neurological and psychiatric disorders. He has been a strong critic of the use of CBT for treating the psychotic symptoms associated with schizophrenia. I highly recommend following his blog LawsDystopia

(3) JohntheJack (AKA JohnPeters -he gave me permission to out him) is a pseudononymous blogger whom I have never met, but feel like I have. I highly recommend his blog, JohntheJack which I sometimes excerpt.  John regularly provides behind-the-scenes feedback on my blog posts at Quick Thoughts and PLOS Mind the Brain. His Twitter bio is

John Peters

Patients writing about their health condition were abused by a peer reviewer and silenced by The BMJ

o

giphyRecently I blogged about authors who were informed by The BMJ that they must keep a review confidential despite having submitted a manuscript under the journal’s laudable policy of open peer review. I did not actually post the review in its entirety because doing so might to make it more difficult for the editors of The BMJ to provide timely, appropriate amends, including an apology to the authors.

I contacted a number of The BMJ editorial staff, starting with the action editor who handled the manuscript. I either got no response or I was told the silencing of the authors concerning their mistreatment was not their doing or anything with which they were willing to intervene.

I am now providing the review, which is patently unprofessional, despite coming from a psychiatrist.

being bmjThe reviewer challenges whether the authors relied on self-diagnosis of chronic fatigue syndrome, perhaps bolstered by doctor shopping until they found agreement.

There were two reviews of this manuscript sent to the authors. Reviewer 1  was succinct and positive:

This is a very well-written and incisive analysis. I would however like to invite authors to comment whether the selection of patients by Oxford criteria might have also partially exaggerated the benefit of trial interventions with graded exercises and CBT.

Should patients submitting manuscripts concerning health conditions provide proof of their diagnoses, such as medical records or letters from their physicians?

Should The BMJ apologize to these patients and their academic collaborator co-authors, given that no such apology has been forthcoming from the Action Editor?

The Editor, Navjoyt Ladher, was trained at Kings College, London where Simon Wessely and Trudie Chalders are faculty.

The reviewer trained at Kings College as well.  He  collaborated  with Simon Wessely on articles concerning chronic fatigue syndrome. I am not revealing his name, but in his review, he indicates that he is a psychiatrist who has mostly practiced in the west of Scotland.

I start by calling attention to some noteworthy points in this 2700 word review. The numbers refer to 13 of the highlighted passages in the review that follows.

  1. The reviewer recommends the manuscript be published without the authors being given the opportunity of revision. The intent of this is that it would draw Rapid Responses protesting what patients with chronic fatigue syndrome have to put up with, including from patients who, like the authors, have the condition.
  2. The reviewer dislikes this paper and yet still wants it to be published.
  3. The reviewer claims the manuscript insults and demeans other patients.
  4. If the paper is published and the PACE investigators don’t respond as the reviewer hopes, the reviewer will post a comment to the authors “Shame on you.”
  5. The authors should just move on and be done with the PACE trial.
  6. The reviewer notes that the paper is billed as a collaboration between patients and scientists, but questions whether any of the authors qualify as “clinicians” or “scientists.”
  7. The reviewer expresses doubts that the patients meet criteria for chronic fatigue syndrome.
  8. The reviewer reiterates the doubt the patients meet criteria for chronic fatigue syndrome and suggests that they were erroneously self-diagnosed.
  9. The reviewer suggests that the authors were erroneously self-diagnosed and went doctor-shopping until they found agreement.
  10. After earlier mentioning that he had not obtained the author’s published review, he questions whether it is a major review.
  11. The reviewer asserts that the PACE investigators can defend the recovery rates they claimed in the PACE trial.
  12. The reviewer questions whether the authors are merely writing about themselves rather than persons with diagnosed chronic fatigue syndrome.
  13. The reviewer claims the authors insult patients with genuine chronic fatigue syndrome when they challenge Wessely’s model emphasizing “fearful cognitions.”

patients should be seenReviewer 2

One of the nice things about providing a referee’s report (and it is even nicer when I am the recipient) is when a fresh look at a manuscript provides simple suggestions that lead to clear improvements in the eventual published paper.  For the 1st time in the three decades that I have been refereeing scientific papers  [1]I am going to recommend publication of a manuscript but only on the condition that no changes are made based on any of my comments or questions or criticisms or praise.  This is because the tone of this paper and certain of its content provide a fascinating illustration of some of the problems that surround the management of people with severe and prolonged fatigue states.  As well as making some quite interesting points these authors provide examples of what people with severe and prolonged fatigue have to put up with – even from other people who themselves have severe and prolonged fatigue.  If this manuscript is published in the BMJ this will give the chance for correspondents in the Rapid Responses section to point out some of its flaws and hopefully a valuable debate will follow that will contribute to a more thoughtful approach to this whole difficult field. 

There has been and continues to be a great deal of scientific controversy surrounding the PACE trial of the treatment of chronic fatigue syndrome(s) using graded exercise therapy vs cognitive behavioural therapy vs adaptive pacing therapy all in addition to standardised care delivered by doctors with specialist experience of chronic fatigue syndrome(s).  The back and forth scientific controversy makes fascinating reading as does this manuscript by …

In my opinion, the differing scientific interpretations of this trial have little or nothing to do with the participants’ scientific training and expertise.  Rather, scientific stances are dependent on people’s personal background and/or their clinical training and/or their clinical experience of assessing and treating patients with severe fatigue states and/or their own personal experience of ill health and/or the illness experience of family members and/or their personal experience of clinical care especially the care they have received from doctors. I will try – briefly and I hope not too boringly – to weave into this referee’s report some of my own background which will perhaps give some understanding of why, overall, [2] I dislike this paper and yet still want it to be published in a widely-read journal.

Whether to publish this paper will not be a straightforward decision for the editors.  It is certainly not an original contribution to the scientific literature.  A paper with similar content by some of the same authors appeared only a couple of months ago in the journal “Fatigue, Biomedicine Health & Behaviour”.  However, if it is published in the BMJ then this would provide a readily accessible update on some of the continuing controversies surrounding the diagnosis, prognosis and treatment of people with severe and prolonged fatigue.  Because of the Rapid Responses/Correspondence section of the BMJ it will give the investigators in the PACE trial the opportunity to put their different scientific interpretations to a wider audience.  They have already published these different interpretations in “Fatigue, Biomedicine, Health & Behaviour”.  I am still waiting for that paper from my librarian but I am certain that these scientists are more than able to defend their trial.  An up to date defence of the PACE trial with balanced consideration of its strengths and weaknesses will be very helpful for clinicians and policy makers if it is published in the readily accessible BMJ.com.  This will, in turn, make it easier when clinicians and health service managers try to improve services for the wide range of patients with severe and prolonged fatigue.

The main reason I would like this paper to be accepted is because of some careless use of language by the authors.  This can happen to anybody and I am sure these authors do not really mean what they say.  [3]They have however insulted and demeaned a subgroup of people with severe and prolonged fatigue (see below).  This is in spite of the fact that [the authors] are themselves in poor health due to severely fatiguing illnesses.  [4] I am sure this will be picked up by the PACE investigators and other readers of the BMJ and highlighted in the Rapid Responses.  If not, then I will write in and tell the authors that they should know better and I think I would end with a “Shame on you”.   

If this manuscript is published in the BMJ and the authors receive the appropriate criticism (and credit) for some the things they have said I hope they will then get on with applying their skills and intelligence and insights to some proper work that will have a chance of genuinely benefiting patients with chronic fatigue syndromes and other overlapping disorders.  [5]It is about time that they moved on from their obsessive (in the non-psychiatric use of the term) poring over the results of a good (albeit imperfect) randomised controlled trial (…and name me one perfect trial that exists in any clinical field).

Here are some comments on the manuscript that may be helpful to the editors in deciding whether or not to publish this non-original paper in a major general journal.  I am hoping that these comments will help draw out how interesting this paper will be to many readers of the BMJ.

1)            These authors make no attempt whatsoever to acknowledge the heterogeneity of patients who are labelled with a diagnosis of chronic fatigue syndrome (and, in my experience, the even greater heterogeneity of the smaller number of patients who are labelled using the diagnostic concept of myalgic encephalomyelitis).

2)           [6] These authors make a big deal of the fact that their paper is the result of collaboration between patients and scientists.  I am still unsure whether that should be clinical scientists.  [authors]– do you have any clinical training and experience?

3)            From what I can gather from this paper and their other writings [authors]  seem to believe that the best definition of chronic fatigue syndrome is whatever condition it is that has led to ill health in [the authors].

4)           [7]  I am sorry to hear of these authors’ ill health.  I hope they will not be upset when I say that I do not accept their diagnosis of chronic fatigue syndrome.  I do not accept at face value anybody’s declared diagnosis of chronic fatigue syndrome until I have done my own history and examination.  The reasons for this are as follows.  When I was a junior registrar in neurology in 1981/1982 our team investigated referrals – including self referrals – of patients with severe fatigue.  They received a battery of investigations from brain scans through lumbar puncture through visual evoked responses to muscle biopsy.  Every test would be normal.  We never took a social history and never carried out a mental state examination.  Come to think of it we never even took a proper past medical history.  The patients would then be told that they had a condition called myalgic encephalomyelitis and would be sent home to rest with the prognosis that they would not improve but that there may be a cure in the future with advances in neurovirology.  As I have written before .. and I have thought to myself on many occasions since – may God forgive me for the part I played in destroying the lives of some of these vulnerable patients. 

I later did clinical work with referrals with severe fatigue in three different clinical and geographical settings between 1988 and 2011.  I found then that a substantial minority (for a period it was the majority) of patients with a diagnosis of chronic fatigue syndrome and myalgic encephalomyelitis had readily diagnosable conditions using basic knowledge of general medicine and general psychiatry.  Sometimes my rediagnosis/reformulation would lead on to effective treatment.  However, some patients would reject these alternative explanations.  Some, sadly, would be angry towards me and state that I was not taking their illness seriously.  It was very disconcerting and it raised major worries about the inadequacies of my clinical communication skills when I would tell a patient with a diagnosis of chronic fatigue syndrome or, more usually, myalgic encephalomyelitis that their profound fatigue and other serious symptoms were better explained by, for example, their recurrent diabetic ketoacidosis; or the systemic effects of their known severe rheumatoid arthritis and its treatment; or their severe psychotic illness and its treatment; or profound depressive illness; or crippling panic disorder; or Reiter’s disease; or obsessive compulsive disorder with co-morbid depression; or malnutrition due to anorexia nervosa; or the temporary aftermath of newly diagnosed and treated severe thyroid disease…….I could go on and on – and then be told by the patient that I was not taking their ill health seriously.

I accept that my experience must have been unrepresentative since I was working from psychiatric outpatient clinics and for most of this time I was based in the West of Scotland that was the epicentre of myalgic encephalomyelitis movement.  However, I cannot believe that I am the only doctor who encountered this phenomenon.  How can I be sure that [the authors]  do not have ill health that could be much better categorised using any one of a range of much more straightforward diagnoses?

5)            [8] Who diagnosed [the authors’] condition?  I do not expect an answer since their medical history is and should remain confidential.  However I have to raise the possibility that they are self diagnosed.  For a while at my clinic a clear majority of diagnoses of chronic fatigue syndrome or myalgic encephalomyelitis had been made by the patient themselves or by a relative or friend or neighbour and not by any doctor or other clinician.  Many (but not all) of these patients had other obvious reasons for their fatigue after taking a full history and doing a physical examination and mental state examination.  I accept that such high frequency of self diagnosis/lay diagnosis may not be found in other clinics but, once again, I cannot believe that I am the only clinician who has encountered this phenomenon.

6)           [9]If they have been diagnosed with chronic fatigue syndrome by a doctor was this by their own doctor?  There certainly used to be a phenomenon whereby patients with a self diagnosis of chronic fatigue syndrome and (even more so) myalgic encephalomyelitis used to go doctor shopping until they found a doctor who agreed with their own diagnosis.  In my experience many (but not all) of these patients had readily diagnosable and fairly straightforward alternative diagnoses. 

7)            I notice in the manuscript that [one of the authors]  says she has “recently co-authored a major critical review of the concept of psychological causation in medicine…”.[10] [Author], I mean no disrespect, but is it for you to say that your review is a major one?  I hope you will not mind my saying that I found it to be very unbalanced and highly selective in its use of the medical literature.  Once again, I want this manuscript as it stands to appear in a widely-read journal so that interested readers will be able to get a clearer view of [this author’s]  thinking and I hope it will be criticised appropriately.

8)            I think [the authors]  are right to question the number of subjects in whom there has been “recovery”.  They may not be aware that the word “recovery” has been hijacked throughout mental health services by the very influential and international Recovery Movement.  This is a positive example of a powerful and creative collaboration between service users and clinicians.  [The authors]  should look it up.  The Recovery Movement has contributed to improved care for many patients especially those with chronic psychotic illnesses.  I think I was the last person involved in mental health services in Scotland – patient or clinician – to argue against some uncritical approaches of the Recovery Movement but I ended up giving in.  I find myself talking to certain patients about recovery – who have no chance of recovery in the dictionary sense of the word.  [11]The PACE investigators will easily be able to defend themselves in regard to recovery in their trial since they have operationally defined what they meant by their use of this word and they have been very clear about changes they made in their definitions.  Nevertheless, [An author] and colleagues do have a point about how reported “recovery rates” could be misleading.     

9)    [The authors] are right that the PACE trial is not definitive.  I have only seen the PACE investigators say this on one occasion and in one paper although I may have missed some other instances.  I think this was just some careless use of language.  Give them a break.

10)   There is something unpleasant in the tone of this article (although I am also being influenced here by outpourings on the Internet).  I cannot help but get the impression that the authors were punching the air when they thought they had come up with support for their views that certain treatment methods for certain people with serious ill health were not as helpful as others (both patients and clinicians) had hoped.  [12] Are [the patient authors]  absolutely sure that they are writing about syndromes of chronic fatigue?  Are they sure they are not simply writing about themselves?

11)         [13] This brings me to the insulting language about certain patients with severe and prolonged fatigue states.  [The patient authors]  are absolutely certain that their condition is not influenced by psychological troubles or social stressors.  This does not give them and their co-authors any right to belittle other patients and understate the severity of illness in those with a diagnosis of chronic fatigue syndrome where such factors are playing a major part in their ill health.  These authors write “…the CBT programme considers patients’ concerns about exercise to be merely ‘fearful cognitions’ that need addressing”.  Earlier in the article they state “This model proposes that there is no major ongoing disease process in CFS – merely deconditioning due to recent inactivity, and its various consequences”.  Merely?  Have they never met anybody with near 100% disability due to mere fearful cognitions?  I have.  Have they never spoken with patients who are at risk of dying due to mere fearful cognitions and their consequences?  I have.  XWilshire and her colleagues should be ashamed of themselves and I think their shameful language should be published and then condemned.  They should then be given the opportunity to write what they really mean and apologise to those patients about whom they have been so offensive.  This is the main reason why I want this article to appear in a widely read general journal that has an active Correspondence/Rapid Responses section. 

I hope these comments are helpful to the editors.  There is such widespread and heated debate around this subject that I think it would be helpful for some of it to appear in a widely-read journal.  I hope the editors will agree with me and publish this article – then stand back and see how the debate unfolds in the Rapid Responses/Correspondence.  I think this will lead in the end to more people with severe and chronic fatigue getting better care packages – which will include for some cognitive behavioural therapy and for others graded exertion therapy and for yet others perhaps even adaptive pacing therapy and for others none of the above but with high quality informed medical care for everybody.  Hopefully it will also contribute to efforts to raise funding for more research projects that will join the PACE trial in giving us guidance about how to treat and how not to treat individual patients with severe fatigue be it explained or unexplained or simple or complicated.

 

 

Rosanne Cash: Resisting a diagnosis of medically unexplained symptoms, being found to have a brain tumor

A moving video provides Rosanne Cash’s testimonial to the power of science over superstition and pseudoscience.

The Grammy award winner suffered over a decade from headaches eventually diagnosed as a result of a rare Chiari I malformation and syringomyelia.

Before getting successful brain surgery, she had to resist misdiagnosis by professionals and New Age healers, some of whom suggested that her not-as-yet unexplained symptoms were a psychosomatic condition and even her fault.

Rosanne Cash credits her eventual diagnosis and successful treatment to the power of science and to strategy of “persist and verify.”

Persist and verify… The power that we abdicate to others out of our insecurity — to others who insult us with their faux-intuition or their authoritarian smugness — that comes back to hurt us so deeply… But the power we wrest from our own certitude — that saves us.

Brain Pickings

Every week I look forward to the arrival of Brain Pickings on Sunday with its free wonderful curated selection of highbrow, but incredibly engaging readings. You can subscribe to weekly alerts here.

This week’s selection was a reading by Rosanne Cash of a poem by Adrienne Rich, “Power,” a tribute to Marie Curie. The poem itself is a great treat, but I’m recommending Rosanne Cash’s first few minutes of very introduction. But I am confident that you will continue to the end of the short poetry reading and hear of the heroism of Marie Curie.

A rare and misunderstood condition

You can find out more about her decade-long struggle to confirm a diagnosis that she’d already provisionally made of herself, as well as the details of her condition here.

The Diagnosis of medically unexplained symptoms

Medically unexplained symptoms (MUS) is a horribly unvalidated psychiatric diagnosis that leads to a cessation of any search for a physical basis for a patient’s complaints. You can learn more about MUS in a blog post by Allen Frances and Suzzy Chapman, Mislabeling Medical Illness As Mental Disorder.

Instead MUS leads to speculations about the primacy of  psychological factors in maintaining and exacerbating her condition.

The diagnosis is not ruled out by actually confirming that a patient has one or multiple physical health conditions, nor even a prescription for medications that may explain some or all the symptoms and complaints.

The diagnosis is applied on the basis of a professional deciding that the life of a  patient like Roseanne had become subsumed by her preoccupation with her complaints.

Many serious physical health conditions initially manifest themselves in vague and intermittent symptoms that could lead to a diagnosis of medically unexplained symptoms.

If a friend or family member informed me that a professional had provided a diagnosis of medically unexplained symptoms, I would suggest they run from that professional and seek appropriate medical care.

Seeking treatment for not-yet-diagnosed medical conditions

it is thought

Goofy and patronizing pamphlet offered to Danish patients

If Rosanne Cash had been in Denmark, she might have encountered Per Fink and his colleagues who would ’have offered a cognitive behavior therapy with no hope of alleviating her problems, but a lot of haranguing and undermining of her conviction that her condition had a physical basis.

Cash might have been offered ineffectual mindfulness training in the Netherlands.

If Rosanne Cash had sought help in the UK, she might have encountered neurologist Suzanne O’Sullivan. Rosanne Cash might have been offered amateurish  Freudian explanations of the source of her suffering in her early childhood experience. You can find an excellent critique by Nasim Marie Jafry of O’Sullivan’s pop book All in the Head here.

In the UK, Rosanne Cash might have gone to an NHS clinic influenced by Trudie Chalder and the PACE investigators that would’ve argued that her suffering was being maintained by false illness beliefs.

Anywhere in the world, Cash might have encountered a professional who has too much faith in a flawed Cochrane review tainted by undisclosed conflict of interest and outcome switching.

In the US, Cash might have gone to a prestigious medical center, only to be informed that her headaches  must be due to her unacknowledged child sexual abuse  – a crackpot, but award-winning theory.

She might even have encountered a trauma-informed therapist who would attempt to co-construct with Cash false recollections of early sexual abuse. If Cash protested that this abuse had not occurred, the therapist might counter that she had repressed the experience and needed more work to uncover it.

But Cash persisted, resisting, and refusing to abdicate to the authoritarian smugness and quackery of the professionals and quack healers and for over a decade.

Excerpts from 10-Year Ache: Singer Rosanne Cash on living with Chiari I malformation and syringomyelia 

I’ve had headaches for as long as I can remember,” says Cash, who lives in New York City and has made a name for herself over the last four decades as a musician and a writer. She has been nominated eleven times for a Grammy and won the 1985 award for Best Female Country Vocal Performance. Her 2010 memoir, Composed, was critically acclaimed.

Cash’s headaches worsened during her second pregnancy. By 1994, they were so severe that she finally consulted with a neurologist. Still, it wasn’t until 2007 that Cash’s Chiari I malformation was accurately diagnosed. The first neurologist Cash went to thought the singer was experiencing cluster headaches—an exceedingly painful and relatively rare kind of headache that tends to occur in a cyclical pattern—but the medications she prescribed offered little help.

The second neurologist, a headache specialist, diagnosed Cash with migraines. When the headaches continued and intensified, the diagnosis changed to atypical migraines.

“This went on for a decade,” Cash says. “A decade!”

And

Rosanne Cash even wondered if she might have a Chiari I malformation after discovering the term online. She discussed it with the headache specialist, but an MRI came back negative. Although most experts consider MRI to be the best way of diagnosing Chiari I malformation, it isn’t flawless, according to Dr. Singh, in part because a malformation can change over time.

The singer frequently experienced neck pain and stiffness, and at times her headaches were severe enough to knock her off her feet. “Sometimes it felt like someone had hit me in the back,” she says. “Once I even dropped to my knees, the pain was so intense.” Her general practitioner determined that she had Lyme disease. “But after she treated me for Lyme disease, nothing changed,” Cash says.

During these years, Cash tried a number of treatments and approaches to managing her pain, including migraine medications, yoga, acupuncture, massage, and chiropractic adjustments. Most offered temporary help at best. “Sometimes not even temporary,” Cash recalls.

Must original investigators get authorship in re-analyses of their shared data?

Last year in New England Journal of Medicine editors Dan Longo and Jeffrey Drazen made a brazen attack on the very idea of routine data sharing.

The editors introduced what they hoped would become a derogatory term of shame, “research parasites” who

 had nothing to do with the design and execution of the study but use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited.

Instead, the editorial gave rise to researchers proudly wearing “research parasites” T-shirts to conferences (I want one!), and then an actual annual reward for best achievement of a research parasite.

An exceptionally well-written letter published in Nature: Genetics, Celebrating parasites -provides descriptions the accomplishments of past and current winners of the annual research parasite awards.

But I think the letter will be remembered for the clearly articulated description of the necessity of secondary data analyses, and the need for such analyses to be conducted and interpreted independent of the individual investigators who generate data.

Some quotable quotes

The act of rigorous secondary data analysis is critical for maintaining the accuracy and efficiency of scientific discovery. As scientists, we make predictions, perform experiments and generate data to test those predictions. When we ask rigorous questions, we obtain more accurate findings that can prevent harm. For example, Vioxx was evaluated for use in treating pain associated with rheumatoid arthritis5. Questions were raised shortly thereafter about its cardiovascular effects6. Independent researchers, using data from multiple studies, identified a drug-associated increase in cardiovascular event risk7. These research parasites identified important side-effects of this drug, correcting incomplete information on the drug’s safety profile.

Parasites also improve efficiency: many data sets were originally designed for specific questions, but these data may also answer distinct but related questions. Investigators can refocus data sets via meta-analysis to reveal general patterns that become apparent only with many studies. Data sets can also be individually useful. New researchers can often bring their own creative ideas to existing data, leading to novel breakthroughs and disruptive innovations.

Importantly, the Nature: Genetics letter explains why secondary analyses of data should not routinely involve original investigators as gatekeepers of co-authors.

Under some proposals for data reuse, data would be shared with researchers working in concert with the investigators who initially analyzed the data1. We expect that this would counteract the recent focus of the US National Institutes of Health (NIH) on rigor, transparency and reproducibility. Any procedure that includes data generators as gatekeepers has the potential to compromise rigor and robustness. As gatekeepers, researchers could withhold data from those with contrary views or a reputation of challenging the status quo. We must expect data sharing to lead to some conclusions being challenged and, ultimately, refuted. If this fails to occur, it indicates a problem with the process and not the correctness of conclusions.

The Struggle over release of the PACE trial data

As many readers know, I’m engaged in a struggle with the senior editors of PLOS One who are protecting the investigators of the PACE trial of cognitive behaviour therapy and graded exercise therapy for chronic fatigue syndrome in their continued refusal to release data they had promised would be available as a condition for publishing in PLOS One.

Release of the data is crucial because:

  1. The investigators had promised the data would be available as a condition for publishing in PLOS One.
  2. The trial was funded in large part with public funds.
  3. The investigators eventually declared financial conflicts of interest they did not disclose to the patients providing data for the trial.
  4. The investigators switched scoring of some primary subject of self-report measures after learning from colleagues conducting another trial that the primary outcomes specified in the PACE trial protocol would be unlikely to produce significant effects.
  5. The investigators suppressed objective behavioral performance and return-to-work data needed to calculate secondary recovery that would have similarly demonstrated a lack of effects of these therapies.
  6. The PLOS One article argues that cognitive behavior therapy and graded exercise therapy were cost-effective, but to be cost-effective, interventions need first to be demonstrated to be effective.
  7. The PLOS One article prominently misrepresents on the first page the investigators as having complied with data sharing policies.

The Nature: Genetics article never explicitly mentions the PACE trial. However, it marked a major breakthrough for critics of the PACE trial when Journal of Health Psychology published an open-access series of commentaries that Harriet Hall blogged about in Science-Based Medicine .

Treating Chronic Fatigue Syndrome with Cognitive Behavioral Therapy and Graded Exercise Therapy: How the PACE Trial Got It Wrong

The struggle to access the trial data

Critics pushed for an independent review of the trial data. They submitted dozens of freedom-of-information (FOI) requests for PACE-related documents and data. The National Institutes of Health (NIH) and the Institute of Medicine (IOM) chimed in, and experts said the deconditioning hypothesis was flawed and untenable. The authors claimed they were being persecuted by patients and advocacy groups. They had received death threats and a phone threat of castration, and one had been stalked by a woman who brought a knife to one of his lectures.

When the trial data were finally made available (only after long persistence, many FOI requests, and a court order), an independent group did a preliminary analysis of “recovery” from CFS using individual participant data. It found that the previously reported recovery rates had been inflated by an average of four-fold. Re-analyzing the data according to the published trial protocol revealed that the recovery rate was 3.1% for SMC alone, 6.8% for CBT, 4.4% for GET, and 1.9% for APT. These differences were not statistically significant.

Fiona Godlee wrote in an editorial in the British Medical Journal (BMJ) that when there is enough doubt to warrant independent re-analysis, “Such independent reanalysis and public access to anonymised data should anyway be the rule, not the exception, whoever funds the trial.”

The authors of the re-analysis said,

The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny. We therefore propose that a thorough, transparent, and independent re-analysis be conducted to provide greater clarity about the PACE trial results. Pending a comprehensive review or audit of trial data, it seems prudent that the published trial results should be treated as potentially unsound, as well as the medical texts, review articles, and public policies based on those results.

Amen. Except I have to add that Harriet Hall got two critical points wrong.

After a legal struggle in which the PACE investigators spent almost 250,000 British pounds lost an appeal and were compelled to release a very limited portion of their data. These are the data that were subject to re-analyses.

In in the Lower Tribunal hearing in which the PACE investigators lost their appeal and were compelled to release the data, one investigator had to concede that reports of death threats were exaggerated and simply false.

Neither the original primary report of outcomes for the PACE trial published in The Lancet nor the claims of cost-effectiveness published in PLOS One can be independently evaluated without release of the data promised as a condition for publishing in PLOS One.

I renew my request that the senior editor at PLOS One obtain release of the data so that I and others can analyze it.

Release is important for clinical and public policy influenced by the claimed results of the PACE trial, as well as the reputation of PLOS One as the premier open access make a journal with enforced data sharing.

And no, dammit, I am not going to let the PACE investigators tell me how to conduct my forensic exploratory analyses nor invite them to be authors. They would just mess up my efforts and produce results consistent with their financial conflicts of interest like investigators did in their own publications.

I blog at a number of different sites including Quick Thoughts, PLOS blog Mind the Brain, and occasionally Science-Based Medicine. To keep up on my writing and speaking engagements and to get advance notice of e-books and web-based courses, please sign up at CoyneoftheRealm.com