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Zombie Science and the Non-Random UK 'CFS/ME' PACE Trial...

Discussion in 'Action Alerts and Advocacy' started by Anglia ME Action (UK), Dec 31, 2010.

  1. Anglia ME Action (UK)

    Anglia ME Action (UK)

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    Dear All,

    In spite of being furnished with a great deal of biomedical evidence from registered stakeholders[1] that contraindicates their 'CFS/ME' Clinical Guideline 53 (CG53), in their recent (and overdue) scheduled Guideline review, The UK National Institute for Health and Clinical Excellence (NICE) have stated that their Guideline Development Group (GDG) sees no current reason to update or amend their guideline[2]. This announcement quite rightly received protests from UK stakeholders and ME charities.

    It would appear however that NICE have given unfair favour to stakeholders who effectively support/represent the psychosocial lobby: stating that "a number of stakeholders advised that the results of the PACE Trial are due to be published in 2011." And which, unlike the extensive biomedical evidence provided, may warrant upgrading of CG53 in the near future. NICE states: "As this significant trial [PACE] may affect NICE's final decision regarding whether its existing guideline warrants an update, NICE is deferring its announcement until further information is available. This is so that the conclusions made by NICE are as accurate and informed as possible. In the interests of high quality patient care..."

    A brief examination of some key points of concern of the PACE trial would therefore be timely in my view as there is every indication that NICE should NOT be viewing said trial as scientifically "significant" and that basing a clinical guideline upon it will be very far from being "In the interests of high quality patient care..."

    Firstly, from the outset the psychosocial PACE Trial was viewed as highly controversial, had significant difficulty recruiting patients and was plagued with an extraordinary high drop-out rate: just some of the reasons that the PACE results are overdue by years.

    Secondly, The Designers and Principle Investigators of PACE have long-standing links with the health insurance industry and have clear conflicts of interest in that insurers stand to gain if patients are viewed as suffering psychosocial illness that is treatable by CBT/GET.

    Thirdly, One of the main financial sponsors of PACE is the UK Government's Department of Work and Pensions (DWP). The DWP also has a clear conflict of interest in potential welfare benefit savings if patients are viewed as suffering psychosocial illness that is treatable by CBT/GET.

    Fourthly, PACE unscientifically conflates patients suffering from the physical neuroendocrine disease known as Myalgic Encephalomyelitis (categorised by the WHO in ICD-10 section G93.3) with those suffering from psychiatric/idiopathic fatigue syndromes (categorised separately by the WHO in ICD-10 section F.48). This is in defiance of good scientific practice and contrary to World Health Organisation medical health taxonomy which the NHS and NICE are legally obligated to adhere to.

    Fifthly, The PACE "Oxford" patient selection criteria are unscientific in that they rule out patients presenting with cardinal symptoms of ME and broadly include those with psychiatric symptoms. These criteria are far from widely accepted in the medical profession and were part funded by PACE Principle Investigator Professor Peter White who also has a long professional association with the medical insurance industry[3].

    Sixthly, the internal PACE Trial Manuals obtained by the ME Community under the freedom of information act clearly and unequivocally show that PACE Trial recruiters and operators were inappropriately selecting and filleting patients in a manner that is far from good practice expected of genuine Randomised Control Trials (RCTs) - see extracts and links below[4].

    Such is the level of concern that PACE is not a genuine Randomised Control Trial, is not genuine science in any recognisable way and is in fact fraudulent, that many complaints have been made. Not least an extensive formal complaint to the UK Medical Research Council (MRC) by Professor Malcolm Hooper that presents truly alarming evidence of alleged scientific malpractice.[5]

    It is a sad reality of modern life that scientific fact and objectivity do not quickley overcome bad science and vested interest. There is good reason to be concerned in this respect with regard to both PACE and NICE CG53. As professor Bruce Charlton states in his peer-reviewed paper entitled 'Zombie Science a sinister consequence of evaluating scientific theories purely on the basis of enlightened self-interest': In terms of the classical theory of science; bogus theories should be readily demolished by sceptical competitor(s) However, in practice, it seems that the even the most conclusive hatchet jobs done on phoney theories will fail to kill, or even weaken, them when the phoney theories are backed-up with sufficient economic muscle in the form of funding.[6]

    Unfortunately, in spite of many concerns that PACE is phoney science based upon bogus psychosocial theory, there is every indication that the economic and establishment muscle behind it is substantial and we are about to have yet more questionable policy-based-evidence substituting for genuine evidence-based-policy. If so, ME patients will not be the only losers. It will be another nail in the coffin of public trust in scientific and governmental integrity. However, even economic muscle cannot hide the truth that ME is a physical illness for ever. I would therefore urge the ME community to keep fighting and keep funding good quality biomedical research. It always seems darkest just before a new dawn.

    Kevin Short.
    31 December 2010.
    contact@angliameaction.org.uk
    [Permission to repost]


    ENDNOTES:


    [1] See for example:
    http://www.angliameaction.org.uk/docs/eame-nice-cg53-response-nov2010.pdf
    http://www.angliameaction.org.uk/docs/25megroup-nice-cg53-response-nov2010.pdf
    http://www.25megroup.org/Campaigning/NICE/25MEgroup NICE Stakeholder ProForma - Nov 2010.pdf


    [2] http://guidance.nice.org.uk/CG53


    [3] See 'Corporate Collusion' at:
    http://www.meactionuk.org.uk/Corporate_Collusion_2.htm


    [4] OFFICIAL UK 'CFS/ME' PACE TRIAL Manuals are NOW ONLINE:
    http://tinyurl.com/3xj3uke
    http://tinyurl.com/37h35ca
    "Evidence from research trials has indicated that patients who are in receipt of benefits or permanent health insurance do less well than those who are not in receipt of them"
    [Extract/quote from Official Pace trial Manual - See below]

    INTRODUCTION:
    Manuals for the PACE Trial have been placed on a file-sharing facility.

    In my view the documents illustrate how psychological and emotional pressures have been applied to individual insecurities and scientific ignorance surrounding ME/CFS, providing insights into the nature and agenda of previous CBT and GET trials, and a view of the disease along with a seemingly acceptable way to treat and portray lay people with ME/CFS. The PACE documents and Study are endorsed/sponsored in the UK by the Medical Research Council (MRC), the Department of Health (DoH), the Department of Work and Pensions (DWP) and the Scottish Chief Scientist Office.

    The files include the official/internal Manuals of the Principle Investigators of the psychosocial UK 'CFS/ME' PACE TRIAL. No ME/CFS activist can afford not to download these large documents, circulate them widely and comprehensively examine them. In the manuals' author's own words, they lay bare what British ME sufferers are about to be exposed to, what underpins that which is likely to be used by NICE to endorse its 'CFS/ME' Clinical Guideline 53 in its imminent internal review, and gives insight into what may lay ahead for patients in other countries that follow the UK model.

    There are two separate large files, both of which contain the same set of Official PACE Manuals along with additional and respectively different sets of relevant bonus materials. They are available to be downloaded using bit-torrent / peer-to-peer file-sharing.

    Either Google "XMRV - THE UK PACE TRIAL..." or go to the short URLs given below:

    File-#1: XMRV - The UK PACE TRIAL [1]
    http://tinyurl.com/3xj3uke
    [IMPORTANT - Click on the small green link at this peer-sharing website entitled "DOWNLOAD THIS TORRENT", don't, repeat don't click on the Large green button with the word "Download" on it as this directs you away from the site.]

    File-#2: XMRV - UK PACE TRIAL [2]
    http://tinyurl.com/37h35ca
    [IMPORTANT - Click on the small green link at this peer-sharing website entitled "DOWNLOAD THIS TORRENT", don't, repeat don't click on the Large green button with the word "Download" on it as this directs you away from the site.]

    I am very grateful indeed to those making these files available to the ME community.

    EXTRACTS/QUOTES FROM THE PACE MANUALS:

    Standardised Specialist Medical Care Page 33 -

    "If participants are insistent that there is an ongoing "physical" problem, it is rarely helpful to directly challenge them on this point. It is important that you acknowledge that their illness is real but its effects can be reduced by the way they manage it."

    Adapted Pacing Therapy Therapists Manual Page 55 -

    "A patients typical day will often look like the record shown below.

    Time Activity

    9.00 am Get up, Take 1-2 hours to come round, Get washed, dressed. Have breakfast. Feed dog, make packed lunches

    10.00 - 12 noon Do various bits of housework

    1.00 pm Prepare and eat lunch

    2.00 pm 5.00pm Rest, often sleep

    5.00pm Walk dog (sometimes)

    6.00 - 8.00 pm Feed children, talk to family, watch TV

    9.0 pm Go to bed take 1-2 to sleep"

    CBT Therapists Manual Page 20 -

    "Perfectionism

    Just as personality can be a factor in contributing to the development of CFS/ME, it can also be a perpetuating factor. People who are perfectionists are likely to have more difficulty in taking breaks or rests in the day as they feel that they are "wasting" time and "should" be doing something useful. This may lead them to adopt a "boom and bust" approach to activity which makes it difficult to establish any sort of routine."


    Adapted Pacing Therapy Therapists Manual Page 42 -

    "Is this a cure?

    Be honest, the answer is no"


    CBT Therapists Manual Page 125 -

    "Many people have successfully overcome CFS/ME using cognitive behaviour therapy, and have maintained and consolidated their improvement once treatment has ended"


    GET manual Page 55 -

    "It should be explained that in order for the body to continue strengthening, and for changes to be maintained, that exercise should form a regular part of their lives from here onwards.

    The long-term benefits of exercise for prevention of CFS/ME specifically, and other diseases in general can be emphasised."


    GET manual Page 59 -

    "In contrast to CBT, it is important that you do not consciously provide cognitive interventions or interpretations e.g. suggest that being able to exercise more may mean that there cannot be a persistent viral infection in their body."


    Pace Trial Management Group Page 31 -

    "Graded Exercise Therapy
    Information for Participants

    There is nothing to stop your body from gaining strength and fitness, as long as it is done in
    a carefully monitored way, relating directly with your own particular circumstances started and progressed at the right rate for you. Good luck!"


    Pace Trial Management Group Page 84 -

    "Your improvements will continue as long as you maintain your level of activity and exercise.
    It is crucially important not to stop exercising after discharge, but rather to continue
    maintaining or building upon the changes you have made.

    Establishing a routine of physical activity and exercise is essential to keep your good health and to prevent symptoms in future."


    GET manual Page 23 -

    "The more severely disabled group of CFS/ME patients were excluded from previous studies as the studies involved an exercise test that may have been too challenging.

    However due to greater levels of inactivity in the more severely disabled group, the deconditioning model should apply equally if not more to these patients."


    GET manual Page 50 -

    "A central concept of GET is to MAINTAIN exercise as much as possible during a CFS/ME
    setback."


    CBT Therapists Manual Page 50 -

    "Current situation (housing, living with, work, benefits, interests)

    This section will draw together a lot of what you may already know. It may help you determine areas that will need to be addressed in your sessions. For example, it may draw your attention to problem areas such as inadequate housing, financial difficulties
    due to not working that may be factors that are contributing to the maintenance of their CFS/ME. Although you will have asked about employment and benefits, it would be
    useful to find out, if they are not working, whether they want to return to their previous
    job.

    There is some evidence to suggest that being on benefits and/or income protection
    (IP) are poor prognostic factors as they are contingent upon the patient remaining
    unwell. Knowing about their current interests/hobbies may be helpful when you come to
    discuss targets for treatment."


    CBT Therapists Manual Page 97 -

    "Discuss potential blocks to recovery

    Participants may be following their agreed programme diligently, but may be experiencing difficulties in making progress, If this is the case, it is useful to identify and discuss possible reasons. There may be some very obvious reasons for their lack of progress, e.g. a total lack of support from a partner, ongoing stressful situations or having another illness on top of their CFS/ME.

    Sometimes the reasons are less obvious. For example, if a participant is in receipt of benefits, or income protection (lP), this may inadvertently lead them not to push themselves too hard. This may result from a feeling of having to prove that they are "still ill" in order to keep their benefits."


    CBT Therapists Manual Page 99 -

    "Being in receipt of benefits or income protection (IP)

    If this is something that has not already been addressed, it is important to address it at this stage. People with CFS/ME are sometimes very keen to come off benefits and it does not cause them too many problems, maybe because they have another source of income. However, it can raise a lot of issues for other people and can be a source of great anxiety.

    Evidence from research trials has indicated that patients who are in receipt of benefits
    or permanent health insurance do less well than those who are not in receipt of them.

    In reality, benefits and IP can help patients financially in the shortterm, but prove to be
    an obstacle to getting better in the long term. In order for benefits or IP to continue,
    patients have to have regular check-ups in order to prove that they are still ill. This can
    understandably be very distressing for patients and be an active factor in maintaining
    their condition. For some patients, returning to work can be very frightening as it may
    have been a major contributing factor to them becoming ill in the first place. Obviously
    for some patients, work is not an option due to the severity of their symptoms.

    For more information on work related issues, please see Appendix 20. There is also a
    section in the participants' manual on work, courses and resources that you may ask
    them to read"


    CBT Therapists Manual Page 100 -

    "Benefits

    Participants may feel trapped by their benefits, i.e. some benefits will stop being paid if
    they earn more than 20.00 a week. Participants may find the prospect of stopping
    benefits and working the number of hours required to earn more than their benefits
    would pay quite daunting. They can also be very fearful that if they come off benefits
    and have a relapse, they will not be able to receive benefits again. It is therefore useful
    to spend time discussing their fears and discuss different options. If they are keen to
    come off their benefits, it is useful to discuss steps to be taken to increase their ability
    to work, e.g. by doing some voluntary work, or permitted work'.

    IP

    For participants who are in receipt of IP, it can be worth discussing the advantages and
    disadvantages of being on it. For participants who feel clear that they do not wish to
    return to that job, it may be useful for them to discuss the possibility of resettlement
    options with their employer. For participants who wish to return to their previous job, but
    feel unable to work the hours that they used to do, you could suggest that they discuss
    a graded return to work, or part-time work. For participants considering a return to work
    it is helpful to suggest that they build up their stamina and confidence in their ability to
    work again, e.g. by doing some voluntary work., For participants who want to leave their
    job, it is worth discussing different options with them and getting them to look at
    different alternatives for homework.

    It is helpful for you to offer to write to employers, insurance companies, be
    involved in meetings with their occupational health department or what ever is
    necessary to help participant to meet their work-related goals."


    CBT Therapists Manual Page 67 -

    "Feeling that a physical cause has been missed and wanting further investigations

    Some participants may not hold a specific belief about what is wrong with them, but feel
    that despite many investigations, something has been missed. They may feel that they
    want to continue having investigations or try a variety of treatments until they are cured.
    Again, it is important to empathise with their situation, but to encourage them to hold off
    having further investigations until after they have completed a course of CBT.

    Participant

    I am feeling so exhausted, I really cannot believe that all my tests are clean l feel sure
    that something has been missed. I think I might go to my GP just one more time to ask
    him if there are any other tests that I could have.

    Therapist

    I can understand that with feeling the way you do, you feel something has been missed. However what I am proposing to do is to help you to understand why you feel as bad as you do and also to see if we can help you to feel a bit better in the process.

    Would that be o.k. ?

    Participant

    But what if something has been missed that could be easily rectified?

    Therapist

    From your notes I can see that you have had many tests, none of which point to a simple explanation for your fatigue. It therefore seems unlikely that someone would be able to detect an obvious cause of your problems. Although I can see the temptation of seeking further clarification of your problems, in reality what can happen is that you end up feeling more confused. I believe that your fatigue is a symptom of a bigger picture and I would like to spend some time discussing my thoughts on this matter with you. I wonder how you would feel about that?

    Participant

    Well, I suppose it wouldn't do any harm!

    Therapist

    What I suggest that we do is to get a large piece of paper and write down what we do know about your illness, including your symptoms, what was happening at the time you became ill and ways that you have been managing to deal with your illness to date. This information may help us to look at factors that may have triggered it and factors that may be involved in keeping it going. I hope this will help us to make some sense of your illness together before we move on to discussing ways of overcoming it. Would you give my suggestion a go?

    Participant

    Yes

    Therapist

    Great. Then maybe that would be a good place to start this session."


    [5] Formal erudite critique/complaint re PACE by Professor Malcolm Hooper - details of which can be
    read by following the paper-trail at these web-links:
    http://www.meactionuk.org.uk/magical-medicine.htm
    http://www.meactionuk.org.uk/Further_Articles.htm


    [6] Professor Bruce Charlton Zombie Science a sinister consequence of evaluating scientific theories purely on the basis of enlightened self-interest, Medical Hypotheses (2008) 71 327-329, DOI: 10.1016/j.mehy.2008.05.018: Available online at:
    http://medicalhypotheses.blogspot.com/2008/07/zombie-science-dead-but-wont-lie-down.html


    - ENDS - PERMISSION TO REPOST -
  2. Angela Kennedy

    Angela Kennedy *****

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    Essex, UK
    How do we know the trial has had a high drop-out rate and difficulty in recruiting, and that this has caused delay in the project? Sources for this would be very useful.
  3. Enid

    Enid Senior Member

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    Oh dear not Zombie science still in the UK. I think these people have lost the plot.
  4. Dx Revision Watch

    Dx Revision Watch dxrevisionwatch.com

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    UK
    Kevin Short wrote:

    How many years?

    My understanding had been that originally, the PACE results had been expected to be published in the spring of 2010 around the time that the FINE Trial published.

    I was told by the Communications office of Queen Mary, University of London (including Barts and The London School of Medicine and Dentistry), on 9 December, that the most recent information the office held was that the paper was not now expected to publish before the end of January. That would not make the PACE Trial results "overdue by years".


    http://www.pacetrial.org/

    Please note that the PACE trial closed to recruitment on 28 November 2008.

    March 2010 update: Data collection for the one year follow up has now been completed. The trial data is currently being analysed in preparation for publication of the findings. Further information regarding publication will be posted here when available.​


    December 2008

    Newsletter

    http://www.pacetrial.org/docs/participantsnewsletter3.pdf

    PACE Trial research results

    Since the first participant was recruited in March 2005, many people would like to know how long it will take before results are released.

    We finish recruiting patients into the trial at the end of November 2008. They have to be followed for a year, until November 2009. During that period, we will be analysing some of the data collected in the first two visits, before treatment, and hope to submit this for publication by the summer of 2009. We will be very busy analysing the main results of the trial in the spring of 2010, with a view to rapid publication in the summer of 2010.
  5. Dolphin

    Dolphin Senior Member

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    I have previously been frustrated by the delay.
    At the same time, it may mean that the peer reviewers are doing their jobs for once and the authors (I think the principal author was PDW) had to re-write some stuff they wrote.
  6. alex3619

    alex3619 Senior Member

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    Logan, Queensland, Australia
    Hi everyone, I wonder if we should be calling it Xombie Science instead? Keep reminding people that XMRV may be a cause and it is being ignored! Bye, Alex
  7. Dolphin

    Dolphin Senior Member

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    (Apologies if I mentioned this before)

    Could the PACE Trialists be hoping to increase the hours the participants worked and hence make treatments look good?

    I think it's interesting to compare and contrast this with some comments the Barts service sent in on the draft NICE guidelines (almost certainly written by Peter White):

    There was a lot worse submitted by the Barts service e.g. how they didn't like accommodations and aids of one sort or another. See link in my sig if you want to read more.

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