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Continuing Correspondence, Countess of Mar and Prof White and Prof Sir S Wessely

Discussion in 'General ME/CFS News' started by Daisymay, Jan 26, 2013.

  1. Daisymay

    Daisymay Senior Member

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    Continuing Correspondence Between Countess of Mar and Prof Peter White and Prof Sir Simon Wessely


    http://www.meactionuk.org.uk/Reply-to-PDW-and-Sir-Simon.htm


    Professor Peter White has responded to the Countess of Mar’s letter published in the “Independent on Sunday” of 13th January:


    From: "Peter White"
    To: "MAR, Countess"
    Subject: RE: Letter to the Independent on Sunday

    Dear Lady Mar,
    As a matter of courtesy and for your information, I attach the link to an IoS wesbite posting from Sir Simon and myself, which was uploaded on Saturday.
    Also for your information, I attach two of my most relevant papers that speak to the important role of infection as an immediate cause of CFS.
    Yours sincerely,
    Professor White

    http://www.independent.co.uk/voices...-online-postings-13-january-2013-8449260.html

    “John Maddox Prize: We would like to correct several errors of fact in the letter published on this website by the Countess of Mar and others. These authors state that we "..have promoted an hypothesis that ME/CFS is due to an abnormal illness beliefs,.. " We have not; beliefs about an illness determine the ways people cope with it, but this has little to do with how the illness develops in the first place (its immediate cause), which our own research has shown can follow certain infections. The correspondents also mention the PACE trial and state that "No data on recovery rates and positive outcomes have been released.." The results of positive (and negative) outcomes were published in the Lancet medical journal early in 2011. The results of recovery rates are due to be published in the medical journal Psychological Medicine within the next three weeks. The authors state that "There has been no attempt by Professor White to correct the misapprehension in respected journals as well as the popular press that the PACE trial demonstrated recovery rates of between 30% and 40%." Again this is not the case; Prof White and colleagues published the following in the Lancet in May 2011: "It is important to clarify that our paper did not report on recovery; we will address this in a future publication." The PACE trial has added to the now overwhelming scientific literature showing that two rehabilitative approaches of cognitive behaviour therapy and graded exercise therapy are moderately effective treatments of what is otherwise a chronic, debilitating and untreatable illness that blights patient's lives. This is good news that needs sharing. Professor Peter White Professor Sir Simon Wessely Queen Mary University London and King's College London”


    Professor PD White
    Professor of Psychological Medicine,
    Centre for Psychiatry, Wolfson Institute of Preventive Medicine,
    Barts and The London School of Medicine and Dentistry,
    Queen Mary University of London.
    Address: Psychological Medicine, St Bartholomew's Hospital, London, EC1A 7BE, UK.

    Tel: (+44)(0)203 465 5696
    Fax: (+44)(0)203 465 7082
    http://bartscfs.eastlondon.nhs.uk

    http://www.pacetrial.org
    ....................................................................................

    And the following is the Countess of Mar’s response, sent on 25th January:

    Dear Professor White

    Thank you for sending me a copy of the reply which you and Professor Sir Simon Wessely tell me was uploaded to the Independent on Sunday website on 19th January. I concede that I do not understand much of it, as semantics is no substitute for science.

    We do not even know what disorder you are talking about because, whilst ethical approval and funding were granted on the basis that you would study CFS/ME and whilst the PACE trial documentation refers to CFS/ME (about which you stated in the PACE trial patient leaflet: “Chronic fatigue syndrome” is “also known as post-viral fatigue syndrome, myalgic encephalomyelitis (ME) or myalgic encephalomyelopathy (ME)….Medical authorities are not certain that CFS is exactly the same illness as ME, but until scientific evidence shows that they are different they have decided to treat CFS and ME as if they are one illness”), in March 2011 you confirmed to the editor of The Lancet: “The PACE trial paper…does not purport to be studying CFS/ME but CFS defined simply as a principal complaint of fatigue that is disabling”.

    I will address the points in your reply one by one: (1) that you have not promoted ME/CFS as abnormal illness behaviour; (2) that the PACE trial outcomes were published in The Lancet early in 2011; (3) that you did correct the mis-reporting in respected journals and the popular press that PACE demonstrated recovery rates of between 30% and 40% and (4) that the PACE trial has added to the overwhelming scientific literature showing that CBT and GET are moderately effective treatments, and that this is good news which needs sharing.


    Your first point (that you have never claimed ME/CFS is an “abnormal illness belief”)

    You and Sir Simon state categorically that you have not promoted an hypothesis that ME/CFS is due to “abnormal illness beliefs”.

    Why, then, was CBT in the PACE trial (of which you were Chief Principal Investigator, with whom all responsibility ultimately rests) provided on the basis that "the symptoms and disability of CFS/ME are perpetuated predominantly by unhelpful illness beliefs (fears) and coping behaviours (avoidance)", whilst “GET was done on the basis of deconditioning and exercise intolerance theories of chronic fatigue syndrome. These theories assume that the syndrome is perpetuated by reversible physiological changes of deconditioning and avoidance of activity”?

    Moreover, in your 2007 paper co-authored with Professors Bleijenberg and Knoop, you state: “The attitude of the therapist towards the treatment goals will affect the expectations and perceptions of the patient…If the therapist suggests that recovery is possible, the patient expectations are raised, which in turn may lead to a change in the perception of symptoms….For complete recovery, the perception of the patient also has to change. The patient has to perceive his fatigue and functioning as both normal and comparable to healthy people….A therapist delivering CBT can tell the patient that…full recovery is possible” (Psychother Psychosom 2007:76:171-176).

    What else can this mean but that you regard ME/CFS, not as a pathological process resulting in chronic multi-system disease, but as a condition maintained by patients’ abnormal illness beliefs which trap them in “self-perpetuating vicious circles of fatigue and disability”?

    If it is the case that you both now accept this theory to be wrong (as your comment on the IoS website implies), this would be remarkable, because you have promoted and championed it for more than twenty years and the PACE trial interventions were based on that hypothesis. Therapists were trained to instruct participants that their symptoms do not result from physicaldisease, with the inescapable conclusion that ME/CFS is considered a non-disease. Indeed, the Therapists’ Manual on CBT taught therapists how to manage participants who believe they have a physical disease, how to persuade them that this is not the case, and how to dissuade them from seeking further medical attention.

    Exactly what do you understand the nature of ME/CFS to be? Clearly, as you consistently disregard the biomedical evidence, including the fact that the MRC now states: “There is now preliminary evidence supporting the view that inflammatory mechanisms in the brain and spinal cord may underlie the pathophysiology of some severe disease CFS/ME phenotypes”,you do not agree that it is a multi-system organic disorder and instead ascribe the protean symptomatology to psychiatric illness.

    Because the issue of what kind of disorder you believe ME/CFS to be is so important, I remind you of the published views of all the PACE trial Principal Investigators (including your own) and of Sir Simon’s views, since he directed and oversaw the PACE Clinical Trial Unit that was responsible for randomisation and database design.

    Sir Simon wrote to me on 21st December 2012 and confirmed: “CFS is not classified as a somatisation disorder. Nor do I believe it should be”. However, his published beliefs about the nature of ME/CFS do not accord with what he wrote to me, for example, his views are that “Functional somatic syndromes…include chronic fatigue syndrome” (Rev Bras Psiquiatr 2005:27:3) and that ME/CFS is “somatisation par excellence” (J Psychosom Res 1994:38:2:89-98).

    You and your colleagues have flooded the literature with terms that you claim categorise ME/CFS, some of these being functional somatic syndrome; somatisation disorder; functional disorder; medically unexplained symptoms (MUS) and medically unexplained physical symptoms (MUPS).

    The profusion of these terms to signify psychiatric conditions whose existence can neither be proven nor disproven illustrates a profound conceptual problem at the heart of liaison psychiatry.

    There is no objective way to prove that a person has a functional somatic syndrome or somatisation disorder; it can only be claimed that no physical cause has so far been found, not that there is no physical cause (ie. one cannot prove a negative).

    Using terms that are deliberately ambiguous, sometimes with the intention of concealing the clinician’s belief that the patient has a mental illness, can only be damaging to the doctor-patient relationship.

    In his 2012 JNNP paper (for which he designed the study and edited the manuscript -- The function of ‘functional’: a mixed methods investigation. JNNP: 16th January 2012) Sir Simon says that: “The term ‘functional’ …has increasingly come to mean ‘hysterical’…(and) its ambiguity was seen as useful when engaging with patients…. ‘Functional’ is a common term for medically unexplained symptoms…It has retained popularity among neurologists as a medical term for conversion disorder….It can, for example, be used to mean a disturbance of bodily function or it can be used to denote conversion disorder, and by telling a patient they have a ‘functional disorder’ they may encourage them to contemplate the former meaning without being aware of the latter…allowing neurologists to use the same term to mean one thing to colleagues and another to patients”.

    Sir Simon explains that the forthcoming DSM V proposes to use the term “functional” as the official diagnostic term for medically unexplained neurological symptoms and that these are currently known as “conversion disorder”, which is a somatisation disorder.

    Sir Simon is known for his view that ME/CFS is now best described as MUS or MUPS and that MUPS is synonymous with somatisation disorder, where the cause of symptoms is mental in origin. MUPS is now used interchangeably with somatisation and functional somatic symptoms (Rosendal M, Fink P et al. Scandinavian Journal of Primary Health Care 2005: 21 (1): 3–10.)

    On the one hand, Sir Simon states that he does not believe that CFS/ME should be classified as a somatisation disorder, however he has also written that it is a somatisation disorder.

    You are on record as disagreeing with Sir Simon and Professor Michael Sharpe (one of your PACE trial Principal Investigators) that there is only one functional somatic syndrome which incorporates ME/CFS together with irritable bowel syndrome, fibromyalgia and pre-menstrual syndrome (by including pre-menstrual syndrome, Wessely and Sharpe ignore the incidence of ME/CFS in males) (Lancet 1999:354:936-939); your view was that ME/CFS is an individual functional somatic syndrome (Brit J Psychiat 2004:185:95-96).

    In 2009 you commented that Sharpe and Wessely believed: “functional disorders…include irritable bowel syndrome (and) CFS/ME. I have argued against this idea, suggesting that the commonality is abnormal illness behaviour, as seen in the process of somatisation” (Psychol Med 2009: 15 April: 1-9:pMID:19366500). Clearly you do promote the view that ME/CFS is abnormal illness behaviour.

    You also contributed the chapter in Clinical Medicine (Kumar & Clark: 2005: pp1281 ff) where the entry for ME directs readers to the entry for CFS, which in turn directs readers to Section 21 (Psychological Medicine) where CFS/ME is listed under “Functional or Psychosomatic Disorders: Medically Unexplained Symptoms”, in which you asserted that the psychiatric classification of these disorders is “somatoform disorder”, which you state were previously known as “ ‘all in the mind’, imaginary and malingering”. In this chapter, you stated: “ ‘Functional’ disorders are illnesses in which there is no obvious pathology or anatomical change in an organ…The psychiatric classification of these disorders would be somatoform disorders. Examples of functional disorders (include) fibromyalgia (and) chronic or post-viral fatigue syndrome…aetiological factors include physical inactivity…. Perpetuating (maintaining) factors include avoidant behaviours (and) maladaptive illness beliefs”.

    In your presentation to The Royal College of Psychiatrists’ Liaison Psychiatry Conference in March 2012 you asserted that ME/CFS is perpetuated by behavioural and psychological factors (ME or CFS: Belief or Science? slide 14). The irony of this is that the ME/CFS battleground represents your beliefs versus medical science.

    In his presentation at the Foundation for Science and Technology event “The future strategy for the management of mental health in the UK” held at The Royal Society on 11th September 2012 Sir Simon repeated your own assertion in his presentation “Health in mind and body” (“CFS: what do we know?”) that ME/CFS is “perpetuated by behavioural and psychological factors” and that there is “no evidence for chronic infection”.

    Your other PACE Principal Investigator, Professor Trudie Chalder, asserts that “Anorexia nervosa and chronic fatigue syndrome are classical psychosomatic disorders” (Advertisement for Research Worker, Institute of Psychiatry, 2007; Ref No: 07/R68).

    What other neuroimmune disease is subjected to such relentless and unjustified dismissal by one particular group of mental health professionals? It is unsurprising therefore that you are seen to be attributing ME/CFS merely to wrong coping ability, in other words, you assume the person had a viral infection from which s/he would have recovered if s/he did not harbour aberrant illness beliefs, ie. no wrong illness beliefs, no ME/CFS.

    You attached two of your own papers (1998 and 2001) that you say “speak to the important role of infection as an immediate cause of CFS” yet in your Lancet report you make no mention of the role of infection.

    Why do you refuse to accept the evidence that it is the physical disease which limits activity? The evidence is convincing that ME/CFS is characterised by an inability to produce sufficient energy on demand (Canadian International Consensus Primer for Medical Practitioners, Carruthers B et al, 2012). Your own studies have not overturned that evidence, nor have they demonstrated that the well-recognised dysfunction of the central and autonomic nervous systems, the cardiovascular system, the musculature and the immune system are, as you propose in Kumar and Clark, merely secondary to inactivity (“Immune and endocrine abnormalities noted in CFS may be secondary to the inactivity”).

    From your own 2004 study on the effect of exercise on pro- and anti-inflammatory cytokines (JCFS 2004:12 (2):51-66) you know that the pro-inflammatory cytokine TNFa remains elevated three days after exercise in ME/CFS patients and that it can have deleterious effects on the central nervous system, TNF being a cytokine that is involved in systemic inflammation. In your article you said: “TNF-a is known to be a cause of acute sickness behaviour, characterised by reduced activity related to ‘weakness, malaise, listlessness and inability to concentrate’, symptoms also notable in CFS”, yet you made no mention of it in the PACE trial literature or in your Lancet report.

    Although your own previous studies have shown a link with one particular precipitating infection (EBV) and post-viral fatigue, the interventions you promote do not equate with management of a chronic infectious disease with a dysfunctional immune system and you treat ME/CFS as primarily a mental health problem.

    With regard to Professor Sharpe’s views about ME/CFS, they are very clear: he believes that ME is a “pseudo-diagnosis”(Occup Med 1997:47:217-227); he believes that people with ME who “refuse to be placed into and accept the stigma of mental illness remain the undeserving sick of our society and our health service” (ME. What do we know: real illness or all in the mind? Lecture given in October 1999 at University of Strathclyde; transcript available); his view is “that the issues around CFS/ME are the same as those surrounding the acceptance and management of (patients) who suffer conditions that are not dignified by the presence of what we call disease” (J Psychsom Res 2002:52:6:437-438) and that: “Factors such as immunological abnormalities are not of clinical value” (BMJ 2002:325:480-483); he believes that classifying ME/CFS as a somatisation disorder has “the most clinical utility” (Trends in Disability: UNUMProvident Report 2002) and he believes that: “Every medical specialty has its own syndrome of… ’functional’ somatic symptoms….Fibromyalgia (and) chronic fatigue syndrome…are just some examples….Patients are assumed to have ‘mental disease’ ” (Editorial: Somatoform Disorders: J Psychosom Res 2004:56:387-390).

    In their chapter in “Somatoform Disorders”, Volume 9, ed: Mario Maj et al 2005 (Chapter 5), Sharpe and Wessely assert: “The majority of patients with CFS…will fit the…criteria for…somatoform disorder”.

    In view of the above, what we said in our letter in the IoS (ie. that you promote the hypothesis that ME/CFS is due to abnormal illness beliefs) is justified and your denial is not supported by the published evidence.


    Your second point (on “recovery” versus “positive outcomes”)

    You say that the PACE recovery rates are due to be published in Psychological Medicine within the next three weeks. Why, when these are the most important issue, has it taken two years over and above the published “positive outcomes” to provide the recovery figures? Such an exceptional delay gives rise to speculation that you are having difficulty in achieving the desired outcome.

    Your Lancet report did not mention “recovery” but assumed that “reversal” of symptoms was possible; however, according to the PACE results, the condition is not reversible with your interventions and the only effect of CBT and GET was to change how participants filled in subjective questionnaires whilst offering no objective improvement in health.

    I look forward to your forthcoming paper on recovery rates with considerable interest, given that in response to an FOIA request to Queen Mary University of London, Paul Smallcombe stated as recently as 1st November 2012: “The requested data relating to recovery rates and positive outcomes do not exist. That is to say that such analyses have not been done and there is no intention to do so. The reason for this is that the analysis strategy has changed from the original protocol”. He went on to explain: “With regards to the recovery rates: the criteria threshold for measuring recovery in the Trial were changed in the light of more detailed consideration of previous published studies…and in the light of newly published work”. This has been interpreted as meaning that you changed the threshold for recovery in light of the very poor results of the PACE trial’s sibling trial (FINE), which used the same threshold that you had intended to use.

    In your letter of March 2011 to the editor of The Lancet responding to Professor Hooper’s formal complaint (which was sent to Margaret Williams by The Lancet), you wrote: “Future papers…are in preparation including reports of economic outcomes (and) different definitions of recovery and remission”. Once again, your position is based on equivocal language. “Recovery” means recovery to full health, nothing less, but you obviously continue to believe that: “The percentage of recovered patients depended on the criteria used for recovery” (Psychother Psychosom 2007:76:171-176). You go into the meaning of standard deviations in relation to an alleged return to “normal” (universally interpreted as “recovery”) whilst then admitting that your version of “normal” is not the same as normal health as interpreted by the average doctor. If a clinician treats a patient with CBT/GET, s/he will not be using standard deviations to measure a patient’s recovery.

    Reporting on “positive outcomes” is not the same as reporting on recovery rates: you and your co-authors Professors Bleijenberg and Knoop acknowledge that: “Improvement and not meeting research criteria for an illness are different from recovering” (ibid).

    If the PACE trial is to be used as a guide for treatment, you need to explain in unambiguous terms what “recovery” mean -- ie. what percentage (and how many) of the 641 participants recovered as per the original protocol, which would be in line with the generally accepted meaning of recovery; what percentage (and how many) returned to gainful employment or study, as well as what percentage (and how many) no longer claimed sickness or insurance benefits as a direct result of the PACE interventions. Such outcomes were the intended purpose of the trial.

    It is disturbing that you have re-defined your own definition of “recovery”. According to your original protocol, “recovery” meant that a participant met all four of the following criteria: (i) a Chalder Fatigue scale score of 3 or less (ii) an SF-36 physical function score of 85 or above (iii) a CGI (Clinical Global Impression) score of 1 and (iv) the participant no longer met the Oxford criteria for CFS, the CDC criteria or your own version of the London criteria (which bore little resemblance to the original London (Ramsay) criteria, since there is no requirement for the presence of the cardinal feature of ME -- post-exertional exhaustion -- or of any neurological disturbance, thus lessening the distinction between true ME and “medically unexplained” fatigue, which is a somatisation disorder).

    Ben Goldacre, writing about the Enhance trial of the cholesterol-lowering drug Simvastatin, stated: "in a trial, you might measure many things but you have to say which is the "primary outcome" before you start: you can't change your mind about what you're counting as your main outcome after you've finished and the results are in. It's not just dodgy, it also messes with the statistics….But the people running the Enhance trial altered their chosen endpoint when the trial was over. They say they did so before they knew the results. That may be so, but it doesn't look good, and they've now had a very serious letter from a US congressional committee demanding to know why it was done….You cannot change the rules after the game has started. You cannot even be seen to do that" (The data belong to the people who gave it to you: The Guardian: 5th January 2008).

    It can be surmised that few if any PACE participants met the requirement for “recovery” as originally specified, which is why you lowered the SF-36 physical function score by 25 points from 85 to 60.

    To date, there has been considerable deviation from the normal scientific process, including the failure of the peer-review process to fulfil its duty as guardian of accuracy in the reporting of the results.


    Your third point (that you did correct the mis-reporting of the PACE trial results)

    You claim that your letter to The Lancet of 17th May 2011 was sufficient to correct the widespread misrepresentation of the success of the PACE trial interventions (“It is important to clarify that our paper did not report on recovery”).

    A number of things can be said about this. First, your Principal Investigators themselves contributed to the misrepresentation, including Professor Chalder's comment at the press conference on 17th February 2011 that: "twice as many people on graded exercise therapy and cognitive behaviour therapy got back to normal", which a reasonable person would understand to signify recovery, but "normal" as defined in the PACE Trial was in fact a level of health so low that a participant could be made worse by CBT and GET and still be classified as having "got back to normal".

    Secondly, when other authors, such as Professors Bleijenberg and Knoop, and then Dr Esther Crawley, claimed (erroneously)in medical journals including The Lancet itself that CBT and GET had resulted in “recovery” rates of 30% - 40%, no action was taken to correct the record.

    By contrast, when David Tuller, writing in The New York Times, criticised the case definition applied in the trial, within days you and Professors Chalder and Sharpe wrote directly to the paper to mount a defence.

    Thus it is the case that when the misrepresentation was in your own favour, it was not corrected, but when comments that were factually correct but were not in your favour were reported, you immediately objected to them.

    That you made no attempt at correcting the misinformation in The Lancet Comment by Bleijenberg and Knoop is not surprising, given that the Deputy Editor of The Lancet has confirmed that you approved it before publication: “The Comment in question was reviewed, as is our standard practice, by the authors of the accompanying PACE trial” (letter dated 22nd January 2013 from Dr Astrid James to the Press Complaints Commission).

    The Deputy Editor goes on to state about my complaint to the Press Complaints Commission concerning the Comment: “We would like to reject this complaint in the strongest possible terms. We believe there are no inaccuracies….We have shared the complaint with Dr Bleijenberg and Dr Knoop and they stand by the content of their published Comment….They stand by their use of the term ‘recovery’….We stand by our publication of the Comment by Dr Bleijemberg and Dr Knoop, and have found no inaccuracy that warrants a correction. We hope that our response is clear”.

    This is in stark contradiction to the email sent on 8th June 2011 by Zoe Mullan, Senior Editor at The Lancet, who confirmed about the Bleijenberg and Knoop Comment that it should be withdrawn: “Yes, I do think we should correct the Bleijenberg and Knoop Comment, since White et al explicitly state that recovery will be reported in a separate report. I will let you know when we have done this”. Despite Zoe Mullan’s assurance, it has not been corrected.

    Such contradiction by The Lancet reflects badly on the editorial staff.

    What you reported in The Lancet article was not “recovery” statistics but the number of participants who fell within your own (artificially low) definition of the “normal range” for fatigue and physical function.

    In your letter published in The Lancet on 17th May 2011 you clarified that no recovery results had been published.

    Why, then, did you approve publication of the Comment? That Comment said: “Both graded exercise therapy and cognitive behavioural therapy assume that recovery from chronic fatigue syndrome is possible and convey this hope more or less explicitly to patients….Have patients recovered after treatment? The answer depends on one’s definition of recovery(quoting the paper you co-authored with Bleijenberg and Knoop: Psychother Psychosom 2007:76:171-176). PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person’s score. In accordance with this criterion, the recovery rate of cognitive behavioural therapy and graded exercise therapy was about 30%....the PACE trial shows that recovery from chronic fatigue syndrome is possible”.

    Bleijenberg himself regards an SF-36 score of 65 as representing severe impairment (BMJ: 2005 January 1; 330: (7481):14), yet in the Comment he implicitly accepts a score of 60 (five points worse) to equate with “recovery”.

    As you approved the Comment before publication, was it not an omission on your part not to inform Bleijenberg and Knoop (and The Lancet) of their error?

    The whole point is that PACE participants did not fulfil your “strict definition for recovery” (which you abandoned) and the SF-36 measure was not plus or minus one standard deviation of a healthy person’s score; you yourself conceded in your letter to The Lancet that you used the mean of an English adult population (not a working age population as you claimed in your Lancet report). This distinction is important because an English adult population includes elderly people and individuals with chronic illness so your comparison for recovery was not, as Bleijenberg and Knoop state, relative to a healthy person’s score. By not comparing with a healthy person’s score (but with the average that included elderly and the chronically sick), you increased the likelihood that PACE participants’ scores would reach your re-defined “normal range” on conclusion of the trial.

    When your Lancet report mentioned one standard deviation, it was in relation to a marker by which improvement could be assessed. As mentioned, you accept that improvement is not the same as recovery and patients could have improved yet be far from “recovered”. On what evidence, then, did Bleijenberg and Knoop claim “recovery” of “about 30%”?

    This, according to the University of St Andrews, is false citation which may be construed as academic misconduct (University of St Andrews. 2013. Policy and governance. 6.1.2 Categories of academic misconduct. False Citation). False citation is the citing of a source for information when the source does not contain that information.
    (http://www.st-andrews.ac.uk/staff/policy/tlac/academicmisconduct/academicmisconduct/).

    As one of the UK’s most respected medical statisticians, Professor Martin Bland, makes clear: “Potentially incorrect conclusions, based on faulty analysis, should not be allowed to remain in the literature to be cited uncritically by others”(BMJ: 19th February 2000:320:515-516).

    No-one from the PACE trial team published a single thing that corrected the greatly exaggerated spin that flooded the media. Merely publishing a letter in The Lancet three months after the media frenzy of misreporting the results of the PACE trial is not sufficient. You, as Chief Principal Investigator, have a duty to at least try to ensure the accurate reporting of the trial results so that patients, clinicians and policy makers will not be influenced by misleading information.


    Your fourth point (your claim that the PACE trial has added to the now overwhelming scientific literature about the efficacy of CBT and GET)

    There is no body of “overwhelming scientific literature” that patients with ME/CFS benefit even moderately from CBT and/or GET. The only objective results of the PACE trial (ie. the six minute walking test) do not support such a claim. Indeed, Sir Simon is on record:

    “It should be kept in mind that evidence from randomised controlled trials bears no guarantee for treatment success in routine practice. In fact, many CFS patients, in specialised treatment centres and the wider world, do not benefit from these interventions” (Huibers and Wessely. Psychological Medicine 2006:36:(7):895-900).

    The very modest benefit in only some patients has been shown to last for only 6 -8 months: “the observed gains may be transient” (Long-term Outcome of Cognitive Behavioural Therapy versus Relaxation Therapy for Chronic Fatigue Syndrome: A 5-Year Follow-Up Study. Alicia Deale, Trudie Chalder, Simon Wessely et al. Am J Psychiat 2001:158:2038-2042).

    This was confirmed by others: in 2003 it was reported at the 6th AACFS International Conference that Dr Daniel Clauw (who had studied 1,092 patients) found that at 3 months there were modest gains from CBT, but at follow-up at 6 and 12 months those modest gains were lost.

    A Dutch report in February 2008 came to unambiguous conclusions about CBT for ME/CFS: the study “does not confirm the high success rates regularly claimed by research into the effectiveness of CBT for ME/CFS”. It found no increase in employment rates, in educational training, engaging in sports, maintaining social contacts and doing household tasks. The majority reported substantial deterioration. Moreover, the length of the therapy did not affect the results. The authors’ conclusion was: “Overall, CBT for ME/CFS does not improve patients’ well-being. More patients report deterioration of their condition rather than improvement. Our conclusion is that the claims in scientific publications about the effectiveness of this therapy, based on trials in strictly controlled settings within universities, have been overstated and are therefore misleading” (Source: Medisch Contact, February 2008, ISBN: 978-90-812658-1-2, by Koolhaas MP, de Boorder H, van Hoof E. The Netherlands).

    In January 2011, the result of a randomised controlled trial (and the PACE trial was not controlled) of the same interventions as those used in the PACE Trial came to very different conclusions at one year of follow-up: M Nunez et al. Clin Rheumatol doi 10.1007/s10067-010-1677-y). At 12 months, the interventions did not improve health-related quality of life scores, with worse SF-36 physical function and bodily pain scores in the intervention group.

    In the six minute walking test at the end of the PACE trial, for those who had undergone GET the mean distance managed was 379 metres, representing a 67 metre increase from baseline after one year of therapy. The results were worse than results for those awaiting lung transplant (400 metres) or those in chronic heart failure (682 metres), and PACE participants were able to walk less distance during the 6 minute walking test than people with traumatic brain injury. After CBT or GET, PACE participants (average age 38 years) did not even achieve a six minute walking distance of 518 metres that is considered abnormally low for healthy people aged 50-85 years.

    In the PACE trial report, you concede that only about 30% were helped “moderately”. However, this figure taken in isolation is misleading as 15% of participants who received standard medical care also achieved the same outcome, meaning that only 15% of participants gained benefit from the addition of CBT or GET. This means that 85% of participants gained no additional benefits from CBT/GET over and above standard medical care, even though you re-defined a “positive outcome” and set the bar at an exceptionally low level.

    On the participant-rated CGI (clinical global impression) of change in overall health, 60% of the GET group reported negative or minimal change after 52 weeks and 58% of the CBT group reported negative or minimal change after 52 weeks. By any standards, that is not a successful outcome.

    In his broadcast on 18th April 2011 on Australian radio, Professor Sharpe said: “We have a number needed to treat; I think it’s about seven to get a clinically important treatment benefit with CBT and GET” (ie. seven patients had to be treated to find one who benefitted). Your results show that only one in seven of those who were only “moderately” affected gained only a “moderate” benefit. That is a woeful result.

    However, the real world efficacy is lower even than this because severely affected and housebound patients were excluded from your trial.

    Professor Sharpe further stated about the PACE trial: “What this trial isn’t able to answer is how much better are these treatments than really not having very much treatment at all”.

    This is very different from the exaggerated spin of “recovery” that was fed to the international media, including the figure of about 30% recovery in The Lancet Comment by Bleijenberg & Knoop, not forgetting the even more inflated but insupportable figure of 40% recovery claimed by Dr Esther Crawley (Esther Crawley et al, BMC Health Services Research 2011, 15thSeptember: 11:217 doi:10.1186/1472-6963-11-217), one of your 26 co-signatories to the IoS letter supporting the award of the John Maddox prize to Sir Simon.

    In the light of this evidence, for you and Sir Simon to claim that the PACE trial adds to the “overwhelming scientific literature” of the efficacy of CBT and GET appears at best misguided.

    I find your position not only incomprehensible, but also inconsistent with what you have written elsewhere, and very much at odds with the reality of the disease.

    I look forward to receiving your considered response.

    Yours sincerely,


    The Countess of Mar

    Permission to repost.
     
  2. Roy S

    Roy S former DC ME/CFS lobbyist

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  3. Stukindawski

    Stukindawski

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    Now this, is the letter I've been waiting for. Thank you Lady Mar.
     
  4. Valentijn

    Valentijn Activity Level: 3

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    Wow, that's quite a huge letter, and every bit of it relevant and to the point.

    Does anyone know where the transcript referred to here is?
     
  5. Min

    Min Senior Member

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    A wonderful letter from a wonderful woman.
     
    Enid likes this.
  6. peggy-sue

    peggy-sue

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    Thank-you, Lady Mar! :thumbsup:
    and thank you for posting, daisymay.
     
    Enid likes this.
  7. Firestormm

    Firestormm Guest

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    I am more moved by the revelation that the recovery data is to be published in 3 months time.
     
  8. Esther12

    Esther12 Senior Member

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    Not 'the' recovery data.

    Yet another newly defined criteria for 'recovery' (unless they've been pushed to release the data according to their protocol by peer review).

    Anyone want to bet that their new criteria will be more demanding than the one laid out in their protocol?

    ...

    I thought not.

    edit: This new claim fits in with what was stated earlier here: http://forums.phoenixrising.me/inde...d-releasing-data-on-recovery-from-pace.20243/
     
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  9. Firestormm

    Firestormm Guest

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    That 'letter' from White is not making sense to me. He refers to a posting in the IOS on 'Saturday' from 'Sir Simon and myself' but the link is to the letter/email from Lady Mar, Prof. Hooper and Dr Weir on 13 January 2013.

    And then we have some " " referring to things that have been said by 'authors' but which were not said in that letter/email on the link.

    edit:

    Also a date would be nice - on the correspondance from White - and I am not convinced that Lady Mar was the only author or contributor to that reply.

    Not that it matters I don't suppose but it would be nice to know.

    Am I going bloody mad or what? :ill: Yes.
     
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  10. Esther12

    Esther12 Senior Member

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    I thought that too, but who knows? It could be that she put it all together herself.

    I've just checked out a couple of quotes for context and they seemed right and accurate. I've not read all of Mar's reply, and won't have time to for a while, but on a quick skim it seemed pretty good. [edit: on page 3 some problems with the claims in the letter are found]
     
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  11. Shell

    Shell Senior Member

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    Someone kiss that fine lady on all four cheeks!:thumbsup:
     
    peggy-sue, Enid and Valentijn like this.
  12. Persimmon

    Persimmon Senior Member

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    St George is engaging the multi-headed dragon!

    Thank you Lady Mar

    Thank you to her helpers, if any (Margaret Williams et al?)

    Wonderful
     
    ukxmrv likes this.
  13. Chris

    Chris Senior Member

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    She deserves all the help she can get--she is terrific! Thank you again, Lady Mar. Chris
     
    peggy-sue and Enid like this.
  14. barbc56

    barbc56 Senior Member

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    What more could we ask for? White actually said what many have wanted to hear.

    Yes, we need to be somewhat skeptical about what a person says and sometimes actions speak louder than words but where do we draw the line for reasonable expectations of a person's behavior?

    As a wise poster wrote, what do we want revenge or to move forward? That speaks volumes.

    Barb
     
  15. Esther12

    Esther12 Senior Member

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    That's what Obama said about the use of 'enhanced interrogation techniques'.

    I don't think that moving forward requires that we ignore the past, or do not hold people accountable for the problems that they have caused. Personally, I think it's the opposite, and real progress is most likely to come when we stop letting those with power slipping away from responsibility. We're all moving forward through time... we can't stop it! Different people have different views about how they want this to happen, but no-one is moving forward any more than anyone else imo.

    More generally...

    I've still not read Mar's letter properly, but for those who dislike the liberal use of ellipses, here's a link to a free copy of the Knoop and White 'Is recovery possible' paper cited above:

    http://www.cfids-cab.org/cfs-inform/Cbt/knoop.et.al07.txt

    Again, while it's possible to disagree with aspects of interpretation, and I tend to dislike the use of ellipses (which may be why my quotes tend to take up more words than my own comments) the quoting I checked seemed fair-ish. A bit less so that the last one I checked, but still better than I was when I was writing essays at uni (I think my standards have gone up a lot due to the way people claim CFS patients only dislike Wessely et al because of out of context quotes).

    The use of the real world Dutch data is important and often overlooked.

    I spotted a couple of possible problems. I'm not sure about stating that PACE was not controlled, instead of pointing to the problems with the controls (this was the biggest problem I spotted). The quote from Chalder about CFS and anorexia being classical psychosomatic disorders is from a job advert for her service (which she may not have written) - it would be nice to get a clarification on this point one way or the other though, and it did come a couple of year before Chandler put out some not very convincing studies arguing for similarities between CFS and anorexia. Generally though, I thought this seemed a solid letter making some good points which have been largely ignored as inconvenient in the medical literature. I'm hoping to give it a proper read soon. [edit: Some problems are mentioned on page 3 of this thread - my skim read missed them, and don't want others to think I gave this a more thorough look than I did. Sorry if I misled anyone]
     
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  16. barbc56

    barbc56 Senior Member

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    I absolutely agree with you about the past. My concern is when we get so stuck in the past we can''t see the future. I think there 's a middle ground here. It's when the negativity colors any positive actions that might occur. When events become mired in arguments that have have been stated over and over.. Again, I think there's a middle ground. We sometimes have to come to terms with the reality of a situation and go from there. This does not mean we should accept everything nor try and find solutions.

    I didn't have time to check the quotes and I did assume they were still taken out of context. I will take your word about them. Saves me some time.:)

    I also have big problems with the PACE trial and wonder what information if any we will get in three months.

    Yup, people do need to take responsibility for their actions.

    We will have to agree to disagree about Mar's advocacy.

    It's the extreme behavior by all sides that I am concerned about.

    I think I may need to go back and edit my post to make it clearer.

    Barb
     
  17. alex3619

    alex3619 Senior Member

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    Not three months, three weeks, from two weeks ago.
     
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  18. barbc56

    barbc56 Senior Member

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    LOL, yea!!!! I just hope the information will be helpful.

    Barb
     
  19. alex3619

    alex3619 Senior Member

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    How does bias, corruption, distortion, and poor practice get into institutions? By secrecy, being hidden. Its not about revenge, its about bringing problems into the open. A problem seen can be fixed. A problem hidden doesn't tend to go away, and new problems accumulate. Transparency and accountability are the issues, not revenge. Revenge has nothing to do with it.
     
    SOC, peggy-sue, Enid and 2 others like this.
  20. ukxmrv

    ukxmrv Senior Member

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    I'd love to move forward. Been trying to do that for nearly 30 years. Still no sign of a cure and harmed twice by exercise programs that I was told would cure the disease.

    No amount of talking to any of the CBT / GET lobby during the past 20 years by myself, patients, family or other interested parties has made a blind bit of difference. They simply don't listen to us, they don't listen to evidence.

    They have made careers out of this. Careers on the ruined lives of patients. The benefits were for them so they clung to ideas that brought them honours, money, acedemic success, prestige and retirement pensions.

    What the COM is doing in public may have some effect. I don't know. It's not the COM or patients who are not capable of "moving forward". The CBT / GET groups are the ones who cannot let go of a concept that never worked.
     

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