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ME/CFS: A disease at war with itself
We can all agree that ME/CFS is a nasty disease, particularly in its severe form, but there are abundant nasty diseases in the world. What is unique and particularly confounding about our disease is that so much controversy surrounds it, and not only surrounds it, but invades it too.
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Hooper's initial response to White re PACE Trial

Discussion in 'General ME/CFS News' started by Daisymay, May 19, 2011.

  1. Daisymay

    Daisymay Senior Member

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    Initial response by Professor Malcolm Hooper to an undated letter sent by Professor Peter White to Dr Richard Horton, Editor-in-Chief of The Lancet

    18th May 2011


    On 17th May 2011 Zoe Mullan, Senior Editor at The Lancet, sent an email to Professor Hooper in response to the complaint he submitted about the PACE Trial article published online by The Lancet on 18th February 2011 and subsequently in the journal on 5th March 2011. In her email, Zoe Mullan wrote: We asked the authors of the PACE trial to respond to your concerns, which they have duly done. Your complaint and their response were discussed at the highest management level and this group of executive editors was fully satisfied that there were no grounds whatsoever on which to take further action. We attach the response provided to us here. From an editorial perspective, the case is now closed.

    The undated response to Professor Hoopers complaint by Professors White, Sharpe and Chalder that was sent to Dr Richard Horton (Editor-in-Chief of The Lancet) on behalf of all the co-authors will, in the interests of openness and transparency, be placed in the public domain and will be fully addressed in due course, as will Professor Hoopers concerns over what he believes is the failure of The Lancets editorial process in this instance, but there is one point in Professor Whites letter that is of particular importance, so it is addressed in this initial response.

    In their letter, Peter White et al state: The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME.

    The sentence continues by stating that the PACE Trial studied: CFS defined simply as a principal complaint of fatigue that is disabling, having lasted six months, with no alternative medical explanation (Oxford criteria).

    This is exactly what the ME/CFS community has been saying from the outset, namely that the PACE Trial was not studying those with ME.

    Soon after the Oxford criteria were published in 1991, one of the co-authors, psychiatrist Anthony David, wrote in the British Medical Bulletin: British investigators have put forward an alternative, less strict, operational definition which is essentially chronicfatigue in the absence of neurological signs, (with) psychiatric symptomsas common associated features (AS David; BMB 1991:47:4:966-988).

    Given that ME is a classified neurological disorder (ICD-10 G93.3), there thus ought to have been no dispute that the PACE Trial Investigators were not studying those with ME, but the Investigators have persistently confirmed that they were studying those with ME, for example:

    1. The PACE Trial Identifier is clear: Myalgic encephalomyelitis is thought by most to be synonymous with CFS (PACE Trial Identifier; 2.1). The cited references for this statement are given as (i) Fukuda K et al. The chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Intern Med 1994; 121: 953-959; (ii) Sharpe MC et al. A report chronic fatigue syndrome. JR Soc Med 1991; 84: 118-121; (iii) Wessely SC et al. Chronic fatigue and its syndromes. Oxford, Oxford University Press, 1998; (iv) Working group report to the Chief Medical Officer, www.doh.gov.uk/cmo/cfsmereport 2002 and (v) NHS Centre for Reviews and Dissemination. Interventions for the management of CFS/ME. Effective Health Care 2002; 7(4): 1-12.

    2. The two versions of the PACE Trial Protocol (both the Full Protocol and short version that was published in BMC Neurology 2007:7:6) are equally clear; the PACE Trial was: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy.

    3. In the Glossary to the Full Protocol, Professor White et al specifically state that CFS/ME is the official term for the illness described in the Working Group Report to the Chief Medical Officer (2002) and the MRC RAG Report (2003).

    4. In the PACE Trial Patient Clinic Leaflet, Professor White et al state: This illness is also known as post-viral fatigue syndrome, myalgic encephalomyelitis (ME) and myalgic encephalopathy (ME). Medical authorities are not certain that CFS is exactly the same illness as MEbut we will be calling this illness CFS/ME.

    In The Lancet article itself, Peter White et al use the term myalgic encephalomyelitis throughout the text and actually state: Myalgic encephalomyelitis is thought by some researchers to be the same disorder.Several diagnostic criteria exist for chronic fatigue syndrome and myalgic encephalomyelitis, thus implying that they had indeed studied those with ME.

    Moreover, in the authors reply published in the Lancet on 17th May 2011 (The PACE trial in chronic fatigue syndrome Authors reply), Peter White is unambiguous: however we defined CFS and myalgic encephalomyelitis, we found that cognitive behaviour therapy and graded exercise therapy provided a significant and clinically useful advantage..

    Here, though, Professors White, Sharpe and Chalder have categorically stated that the PACE Trial does not purport to be studying CFS/ME.

    This may explain why so many recruits were not accepted into the PACE Trial on the stated grounds they did not fulfil the Oxford criteria for CFS (which according to the Principal Investigators themselves, is not the same as CFS/ME).

    If the PACE Trial was not studying CFS/ME (as now asserted by Professor White et al), then the results cannot be used by NICE to support its Clinical Guideline 53 for CFS/ME.

    NICE, however, announced on 14th March 2011 that there will be no review of CG53 until 2013: interventions recommended in the original guideline, such as CBT and GET, were described as the interventions for which there is the clearest evidence-base of benefit. This is supported by the recently published PACE trial.The results of the study are in line with current NICE guideline recommendations on the management of CFS/ME.There are no factorswhich would invalidate or change the direction of the current guideline recommendations. The CFS/ME guideline should not be updated at this time.

    Most certainly, this statement by the Principal Investigators that the PACE Trial did not purport to be studying those with CFS/ME raises important issues about the alleged generalisability of the PACE Trial results, given that The Lancet article unambiguously states: The PACE findings can be generalised to patients who also meet alternative diagnostic criteria for chronic fatigue syndrome and myalgic encephalomyelitis but only if fatigue is their main symptom.

    That The Lancet supports the Principal Investigators inconsistent and indefensible position and refuses to engage with clearly articulated complaints must be of concern to anyone interested in the integrity of the scientific process.

    Permission to repost.
     
  2. Enid

    Enid Senior Member

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    It's just unbelievable that both White and the Lancet cannot see the inconsistancies behind the trial and therefore the muddled position they continue to hold in ME/CFS.

    Thanks for posting dasiymay - a very revealing piece.
     
  3. maryb

    maryb iherb code TAK122

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    Thanks for posting that daisymay, be interesting to see who takes it up from here.
     
  4. SilverbladeTE

    SilverbladeTE Senior Member

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    What has "reality" had to do with official positions in the UK on this disease in the last 30 years, hm? ;)Seriously, these bozos have pushed themselves backwards onto the edge of a precipice by their own bigotry, hubris, lack of compassion, lack of intelligence and cowardice.

    These people MUST let us all suffer and die, so their abominable crimes can be "glossed over". if it is ever shown ME is a "real disease with a specific cause and treatment or cure", in public, they will face trial for mass murder, genocide, fraud, crimes against humanity, etc.
    Therefor, they will NEVER accept the reality of this disease, just like history's criminals let their people, allies, nations be destroyed aorund their ears rather than admit their crimes and stupidity.
    This, is the "Furher Bunker" of the medical world, Tuskegee Experiment writ large.

    "It's just unbelievable that both Nazi Germany and the Inquisition cannot see the inconsistancies behind the trials and therefore the muddled position they continue to hold"
    to re-purpose your quote as example ;)

    "There are none so blind as those who WILL NOT see"
     
  5. Enid

    Enid Senior Member

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    Dare we suggest the psychiatrists attend the Invest in ME London Conference tomorrow with International Researchers - pathologies/findings/treatments etc. - or would that ruin their "theories". And they could learn about the real subject matter.
     
  6. Daisymay

    Daisymay Senior Member

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    They know the biomedical evidence all too well, they just choose to, have to ignore it because the scientific evidence completely invalidates their view, their assumption, which they clearly stated in the PACE paper, that CFS is perpetuated by patinets wrongly thinking they are physically ill, fear of excercising and deconditioned.
     
  7. Enid

    Enid Senior Member

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    Even more reason to "invalidate" their position if they are aware of all the research I suggest dasiymay. Not only inconsistancies in the trial basis but mumbo jumbo about "wrong thinking" - are these the strangest (and dangerous) bunch ever to try to invade real medicine. The arrogance of their "ideas" knows no bounds, and I suggest - you - Sharpe et al are exactly that - the wrong thinkers. Their position smacks of brainwashing. It's been tried on me following collapses in A & E - and definately not recommended.
     
  8. Daisymay

    Daisymay Senior Member

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  9. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    This is totally outrageous, but unfortunately, par for the course for these charlatans. Thank God for Prof. Hooper!

    And yet everywhere else they claim to have studied "CFS/ME" in PACE.
     
  10. SilverbladeTE

    SilverbladeTE Senior Member

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    Oh, by the way...
    am I the only one who thinks that White et al, were really working on "feacal transplant", but got mixed up and sat down for a really big heaped bowl-full of their own medicine?

    *he says with a perfectly straight face...and walks away, whistling the the tune from The Third Man* :p
     
  11. Bob

    Bob

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    Well, I think this is a very important quote to keep handy at all times!:

     
  12. Enid

    Enid Senior Member

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    But it doesn't read like this from Prof Hooper's letter above Bob - ME =CFS interchangeable.
     
  13. Bob

    Bob

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    I'm not quite sure what you mean Enid. I've just quoted White from the letter.

    White is saying that he didn't study the UK's CFS/ME patient population, which we already know, but it's handy to have it confirmed in writing from him.

    He has just studied a group of fatigued patients, which he refers to as 'CFS' patients, but which do not reflect any international CFS patient populations.

    The Lancet paper does refer to 'ME', but it did not study an ME or CFS/ME population.
     
  14. Enid

    Enid Senior Member

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    Take your points Bob but it's the "Pace Trial Indentifiers" etc Prof Hooper highlights that muddy the waters for ME/CFS (the real thing).

    Off thread - just wishing I could be a fly on the wall - Iime researchers/gov meeting, Hilary Johnson address, Conference today, researchers get togethers etc., but hopefully we will hear soon.
     
  15. Dolphin

    Dolphin Senior Member

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    I don't think that quote is that exciting. He says it doesn't apply to "CFS/ME" (as for example the Canadian criteria were not used) but in the paper he says it applies to both CFS (International (2003) - very similar to Fukuda) and M.E. (London criteria), albeit, that they have to have fatigue as their main symptom.
     
  16. Angela Kennedy

    Angela Kennedy *****

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    Hi Enid- I would really suggest not to worry about this. This is good news, and I for one will be able to make great use of it- and I am really sure Malcolm Hooper will be making excellent use of this statement, for various reasons this strengthens people's complaints.
     
  17. Bob

    Bob

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    Hi Dolphin,
    Does the paper actually specify that they are refering to the empirical/2003 definition?
    I had thought that they didn't specify which international criteria?
    Thanks for any info,
    Bob
     
  18. Angela Kennedy

    Angela Kennedy *****

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    Hi Dolphin

    On the contrary- this is an extremely important quote for those of us working on specific issues, believe me. I know you have your own topics re PACE which you feel are important, and they are. But this is on another vital issue that others of us have been working extremely hard on. Don't underestimate it's importance.
     
  19. Bob

    Bob

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    Well, we really need to see the whole quote, in context.
     
  20. Angela Kennedy

    Angela Kennedy *****

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    Hi Bob

    This is one of the issues I've been working on. Can I suggest you read my complaint to the Lancet? I've published it here on a dedicated blog for ease of referral:


    http://pacedocuments.blogspot.com/
     

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