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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. Bob

    Bob

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    It seems that I've been making some false assumptions about NICE.
    I had thought that NICE only recommended the CDC criteria, but it seems that NICE does not insist on any particular criteria being used, but gives details on a range of them, and NICE does not seem to give special prominence to one particular criteria.
    They include a mention of the Oxford Criteria in the NICE Guidelines.

    So it seems that the PACE Trial is relevant to CFS/ME, as recognised by NICE.
    That's rather depressing.
    (Diagnostic criteria have always confused the hell out of me.)



    Here are some extracts from the NICE full guidelines about diagnostic criteria...

    5.2.1 Evidence statements

    Key clinical question 1

    5.2.1.1 Evidence to substantiate existing case definitions of CFS or ME is
    limited. No studies have established the superiority of one case
    definition over another
    (Evidence level 2).

    5.2.1.2 Community-based studies have indicated that patients meeting CDC
    1994 criteria
    form a more heterogeneous group than patients
    meeting CDC 1988 criteria (Evidence level 2).

    5.2.1.3 There is currently limited evidence that patients meeting Dowsett ME
    or the Canadian criteria are more likely to have more symptoms than
    those meeting CDC 1994 criteria (Evidence level 2).


    5.2.2 Clinical evidence summary

    5.2.2.1 Summary of evidence presented in Appendix 1 Question 1 part 1
    diagnostic criteria

    The Oxford Criteria of CFS/ME, developed in 1991 by a panel of clinicians and
    scientists, defined CFS/ME as a syndrome in which fatigue has been present for at
    least six months, during which time it has been present more than 50 per cent of the
    time. Other symptoms may also be present, such as myalgia, and mood and sleep
    disturbance.27

    In 1994, new criteria were drawn up by the US Centers for Disease Control (CDC),
    the 1994 CDC/Fukuda CFS Criteria.28 The CDC definition included the requirement
    of the presence of new-onset fatigue lasting at least 6 months and the presence of at
    least four of eight other physical symptoms.


    Australian 2002: Recommend (with provisos or alterations)

    Canadian 2003: Would not recommend

    UK 2002 (CMO Report): Recommend (with provisos or alterations)


    http://guidance.nice.org.uk/nicemedia/live/11824/36191/36191.pdf
  2. Angela Kennedy

    Angela Kennedy *****

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    This does not change the importance of what Hooper has released.
  3. Bob

    Bob

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    Well, it does put a spanner in the works, as far as I can see, because NICE seem to recognise the Oxford Criteria as being relevent to what they call CFS/ME.

    I had partly been basing my approach to the PACE Trial on the fact that the Trial didn't study ME patients, and it didn't study ME/CFS patients using any officially recognised criteria, but it seems that I have got the latter point wrong.

    So now, as far as I can see, the main argument against the PACE Trial needs to be focused on the results and the data.

    There is also a bigger argument to be had, that NICE should be recognising ME/CFS as a separate disease to Chronic Fatigue. But that doesn't relate to the PACE Trial results.
  4. Angela Kennedy

    Angela Kennedy *****

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    Actually -NICE are mistaken about the Oxford Criteria (the original Oxford criteria show that) and what it purports to show.

    And this is where it becomes interesting. There is no spanner in the works...

    Please realise the issue is far bigger than the outcome data. People have over-focused on this to the exclusion of other extremely important issues. This is short-sighted. Please Bob, if you haven't already, read my complaint and that of Malcolm Hooper thoroughly- re-read if you aren't fully cognisant of the points. At this stage, I do not want to be arguing in public with fellow advocates why Thursday's news is so important, as I think I indicated to you in my pmail?

    I've been supportive of the outcome data discussions- even when I've been unsure of their relevance. I'm asking for the same attitude towards my work here. I feel you have not understood the importance of the other issues highlighted by myself and by Hooper, and I'm asking you as a fellow advocate not to poo-poo this highly important development or the issues I've been raising, as you have not been concentrating on the issues in this area and may not be aware of their importance.

    This is said with respect and no malice intended.
  5. Enid

    Enid Senior Member

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    Quite agree Angela "the issue is far bigger than the oucome data" and Prof Hooper (Emeritus) has been in ME well over a decade. He is also very wise and knowledgeable and one of the leading lights/advocates for ME in the UK. So I think we can safely be assured that any of doubts he raises are of concern to whole community in the UK. And thanks to Angela too for her continued work in the ME "saga" here.
  6. Angela Kennedy

    Angela Kennedy *****

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    Thank you Enid, your kind comment and understanding is really, really appreciated.
  7. Mark

    Mark Acting CEO

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    For what it's worth, my own impression (from a certain degree of distance from the detail) is in accordance with what Angela is saying. I agree that there seems to have been a particular focus on outcome data, and that there are other issues, including issues of cohort definition and selection, which are extremely important and may have been underplayed so far. It's interesting that the response of Prof Hooper in particular seems to have been frozen out of a 'more reasonable' critique and I think we should all be cautious before accepting that because it's entirely possible that the critique which is the most dangerous and damning is precisely the one which may be sidelined.

    Returning to the specific quote that's attracted attention, because even though it is not from a publication it still does seem to me a very significant comment...

    A related issue that I think we should make a great deal of, is the process by which patients were selected - and rejected - for inclusion in the PACE trial. If I understand correctly, patients were initially selected from outpatients enrolled at specialist CFS treatment centres, having previously been diagnosed with ME/CFS by their physicians. And yet over 75% of these specific patients were deemed unsuitable for further study by PACE, having been determined by the study team to "not have ME/CFS" because they had neurological symptoms or other undiagnosed conditions.

    It seems to me, therefore, that one of the most significant findings of PACE itself is that over 75% of people diagnosed with ( CFS? ME? ME/CFS? ) do not actually have it, but have either some other undiagnosed illness - and the PACE trial explicitly excluded those kinds of patients, even though they are diagnosed with ME/CFS, and therefore the PACE conclusions do not apply to those kinds of patients.

    I realise I have not presented this point rigirously here, and it would need to be worked up somewhat, but that basic finding, surely, is a massively important conclusion, which ought, in a rational world, to have a very significant impact indeed on the NICE guidelines for ME/CFS - the most common conditions that 75%+ of those people diagnosed with ME/CFS actually had would surely be useful data to release...
  8. Bob

    Bob

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    Hi Angela,

    I don't remember receiving a PM from you recently?

    I can assure you that I'm not poo-pooing anything...
    I'm just placing my thoughts on the forum for discussion.
    My thoughts are never set in stone and I always review the facts and give thought to other points of view.

    I've read Hooper's document, twice, but I haven't read both of your letters yet Angela...
    But I shall print them out and read them later.

    I'm supportive of all of the issues surrounding the rebuttal of the PACE Trial - including focusing on both the results and the selection criteria.
    I've been focusing on both. I don't see any need to choose one or the other.

    I think I understand the issues surrounding the criteria, and White comments, but I think you maybe missing part of the picture here Angela. Or I am?

    I agree with you about NICE, and I don't think i'm being short sighted...
    I just think that there are two separate issues here, even though they are intertwined issues...

    One issue is the PACE Trial, and the other is NICE's guidelines for ME.

    I can't see how White's words can have any relevance when we are dealing with NICE.
    I can't see that NICE is suddenly going to change their whole approach to ME/CFS just because of those comments of White's.

    I agree that the PACE Trial did not investigate ME patients, but that's not what NICE believe. CFS and ME are the exactly same for NICE.

    I don't know what political significance White's comments will have, and how helpful they will be of help to us, because NICE treat ME and CFS as the same condition... So his comments make no difference to us unless we can get NICE to change their approach to CFS/ME. Only if NICE start to treat ME as a real disease will White's comments be useful for us, but then the comments will be redundant anyway.

    At a simple level, we can say that White said he wasn't investigating ME, but White is much more clever than giving us something on a plate like that... He's cunning and clever... And he will probably use his words in his favour, and against our community, although I can't see exactly how yet... He might just point out that no one in the UK gets diagnosed with ME, thus attempting to isolate 'ME' advocates who understand that they have a neurological disease.

    I also don't see how he can separate the ME and CFS. It might be easy for us to separate ME from idiopathic fatigue, but he will not admit to investigating idiopathic fatigue, or chronic fatigue. Even the WHO doesn't explicitly separate ME from CFS, as far as I understand.

    If we can use White's words as a tool in the political arena, then that's great. I hope we can, and I intend to look for appropriate ways to use them myself.

    I'd be grateful if you tell me what i've not noticed here Angela, baring in mind that I'll read your own letter later.

    And please don't view this message as being argumentative... I'm genuinely interested in understanding your point of view, and have just told you what i think so that you can see where i'm coming from on the subject.

    Bob
  9. Guido den Broeder

    Guido den Broeder *****

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    Hi Mark,

    ME is a postviral brain disorder, so ME patients have neurological symptoms (many, in fact, and easily recognizable). So if neurological symptoms were an exclusion criterium, zero patients in the PACE trial had ME.

    What the authors did was exclude all ME patients and keep the noise, instead of the opposite.

    Regards,

    Guido
  10. Angela Kennedy

    Angela Kennedy *****

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    Bob, you do need to read my complaint, I think. Otherwise you are sort of arguing from a point of ignorance. As I said before, I do not want to be arguing your points, as what White has said has very much strengthened my complaint, but I would, reasonably, like to keep my powder dry, and not allow this to fizzle out in a sea of speculation and fear of Peter White and his allegedly amazing supernatural cunning, frankly! Good god - these psychs aren't Svengalis, for goodness sake!

    If we were all more transparent about who we are (I am, I know, but I'm one of the few) I would probably feel safer in discussing the work I've been doing. I don't presently. You may not know I've been working to ascertain the discrepancies in the psychiatric paradigm of ME/CFS since 2003, and I was one of the first public critics to go up against the psychs.

    But the comment you made about

    is belittling the work I'm doing NOW, and have been doing, Hooper's complaint, and endangering some vital advocacy going on in an area which could be a game changer.

    Now if you want to carry on doing this- I can't stop you. But I have to say you are arguing from a position of ignorance, and I cannot explain in detail why because this is not a safe arena to do so (though the fact you haven't read my complaint is one example of ignorance). If you just will not understand (or are perversely ignoring) what I am trying to tell you here about supporting other advocates and keeping powder dry, then I just am not able to trust you with the information I have!
  11. Guido den Broeder

    Guido den Broeder *****

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    They do, actually. ME is in the table, as a disorder, while CFS appears only in the alphabetical list of disease terms. And that is exactly the difference: CFS is not a disorder. It is a working case definition for one purpose only: to (easily and cheaply) select participants for scientific research. It was never meant for diagnosing patients.

    This was made very clear in the Fukuda article of 1994, I think. It was even explicitly stated that the criteria were widened so as not to miss any patients. This increased the noise factor to some 50% (see Jason).

    Regards,

    Guido
  12. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Focus on the Fundamentals: the Fake Definitions

    I can't see inside White's head, so I can't say, and we need to look at the White letter when it comes out, but it looks like from the quote that he slipped and admitted he wasn't studying ME (aka "CFS/ME"). This single admission will not blow everything up, but it is very helpful in arguing exactly what he said- that Oxford "CFS" is tired people and does not define ME. This is useful in arguing against PACE and against the current NICE guidelines. I do understand what you are saying that NICE embraces the fake "CFS" definitions to the exclusion of the best ones (CCC). There were plenty of flaws in the study other than selection criteria, true. I just feel that we would be best served sticking to the 'fundamentals' and hammering away at that every time we advocate, until they are resolved.

    I consider the fundamentals to be that the name of ME was inappropriately changed by CDC to "CFS." CDC, NIH and the UK psychs carry on a campaign for years of straight up lying about "CFS". Then a more subtle strategy is adopted- With Oxford 1991, Sharpe et al. change the definition in the UK of "CFS" to mere Idiopathic CF. Then they do all these studies with this fake definition and write tons of review articles incorporating these fraudulent studies. They claim that CBT/GET are the only evidence-based therapies proven to work, based on these fraudulent studies. Unfortunately, CBT and GET are the worst thing you can do for ME since it tells the patient he does not have a physical disease and ratcheted up exercise is the only proven treatment, so it is forced upon the ME patient, worsening the disease.

    CDC saw that the UK psychs had great success with their patently fake definition, so they made up their own- the Reeves criteria, and started doing studies to increase the amount of fake data. They are carrying out this scam of using fake definitions in broad daylight. We need to shine even more light as intensely as we can on this fundamental basis of their scam until it is recognized by a critical mass of the medicine/science community.

    I think we need to focus on these fundamentals because it is hard enough to get people to understand and believe that this has been done. If we start adding in a lot of other arguments then these important points can be lost. Of course, if one is doing a complete, detailed critique, one can add in some other arguments, but keep the focus on these main points.

    If we persuade medicine and science to fix these problems and throw out the fake studies, we will have accomplished a huge amount and can then move forward with real science. Until then, we will forever have a jumble of real and fake science which is practically useless clinically.

    If, instead we make all the arguments without strongly highlighting the 'central' arguments, then I believe the vast majority will not be convinced because they will become confused with all the arguments and data. In their defenses, White et al. focus on the problems other than selection, and reviewers will probably come away with White's idea that the extent of improvement is in contention, but that CBT/GET is the only proven beneficial treatment, so it should be used because it may provide some benefit, even if small.

    We need to emphasize that these 'treatments' are like poison to pwME and will worsen the disease. If people are persuaded of this then there will be informal resistance in applying the guidelines and eventually the NICE guidelines will be changed.
  13. Bob

    Bob

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    Yes, CFS in the index links to the neurological disorder ME, suggesting that 'CFS' is another term used for 'ME', rightly or wrongly.

    However, the WHO does totally separate ME from idiopathic fatigue and 'fatigue syndrome'.
  14. Enid

    Enid Senior Member

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    Quite so Angela - we are focussing here on the implications clearly indicated in Prof Hoopers letter only (as the original post on this thread).
  15. Bob

    Bob

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    I'm not sure what that is supposed to mean Enid?

    Have you read White's comments in the first post?
  16. Enid

    Enid Senior Member

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    Bob - I am not interested in the Whites of this world but in those dedicated to clarifying the disease known as ME. for what it is.
  17. Bob

    Bob

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    But White's comments are the basis of the original post that you mentioned. The purpose of the post was to convey White's comments.
  18. Angela Kennedy

    Angela Kennedy *****

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    Thanks Enid. You are right.
  19. Angela Kennedy

    Angela Kennedy *****

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    Good points Justin.
  20. Enid

    Enid Senior Member

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    There were/are the basis of Prof Hooper's critical analysis of the inconsistancies but much more implication for the whole world of Medicine. Add what we can and leave it to them. Things coming thick and fast - this is addressed to Bob. Criticism (rightly of pseudo sciences who hope one day to explain all in their mumbo jumbo) we and science can do without.

    Answer to Bob - post 57.

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