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Patients to DHHS: Fix the Broken ME/CFS Case Definitions NOW!

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, May 14, 2013.

  1. Ember

    Ember Senior Member

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    Thanks, Bob, for clarifying your references. As you say, my comments were posted a year ago, after the publication of the ICC. At that time, we were discussing the relationship between ME and CFS in the context of the NCHS reclassification request and the Joint Request for Action. The NCHS reclassification request had claimed that “when properly defined, CFS is the same as ME,” and the Joint Request for Action claimed that “many experienced clinicians and researchers recognize the equivalency or close similarity of ME and CFS based on the growth in scientific understanding and have adopted the term ME/CFS. All of DHHS should follow the NIH’s lead and adopt the term ME/CFS as recommended by the CFSAC in October 2010.”

    You found the discussion constructive (“Wow, what a constructive thread!”) and offered to extract proposals or suggestions that could then be discussed and debated. You challenged me to produce published guidance supporting the separation of ME from CFS. In developing a proposal that differentiated ME from CFS, I drew first on an interview explaining that the CCC was originally intended to be an ME definition and then on Dr. Carruthers' published reference to a study by Dr. Jason comparing the CCC to Reeves (2005) and confirming the separation of ME from CFS cases in that context.

    During those discussions, we noted certain gaps within the expert guidance. Mary commented, “For everything that ICC does to explicitly state that ME patients defined by ME-ICC should be removed from patient populations defined by the NICE criteria and Reeves empirical criteria, it was silent on how to handle patients diagnosed by Fukuda. I wish I knew why.” She and I privately questioned whether it would be appropriate to seek clarification from the International Consensus Panel.

    As a patient of Dr. Carruthers' at that time, I took the opportunity to explain to him the need for expert guidance concerning the relationship between the ICC and Fukuda, particularly for the benefit of American patients. He encouraged me to contact the International Consensus Panel. Clarification from the Panel came last October in the ME Primer.

    The statement by the International Consensus Panel clarified not only the relationship between the ICC and Fukuda, but also the relationship between the ICC and the CCC. It divided the CCC, removing ME patients who meet the “refinement of patient stratification” provided by the ICC: “Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.”
  2. Valentijn

    Valentijn Activity Level: 3

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    I've been interested in genes lately, so took a closer look at this one:

    NFKB1 (NF-Kappa B1) is the location of one my rare alleles (rs4648039), so maybe that's related?
    Bob likes this.
  3. Ember

    Ember Senior Member

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    The studies that you've posted are included in the ME Primer's discussion of the pathophysiology of PENE (pp. 2-4). I haven't listened yet to the whole of Dr. Snell's FDA presentation. Does he mention any newer studies underway?
  4. Bob

    Bob

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    It's not a long presentation, but I haven't yet listened to it all the way through either. I haven't seen him discuss any post-exertional research apart from his own VO2max / cardiopulmonary / anaerobic threshold work. Someone else has said that Dr Snell has a new study pending, but I don't know the details, and I haven't yet noticed Snell mention this in the video.
  5. biophile

    biophile Places I'd rather be.

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    Wait a minute. Even if it turns out that the two-test VO2 Max is not significantly associated with small groups of ME/CFS patients, the test itself is still reliable, correct? So what happens to those people who previously dropped up to 50% on the second test??? Are such dramatic and unique results for some individuals just going to be ignored as outliers?

    I still await with interest the latest update on anaerobic threshold research.
  6. Bob

    Bob

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    I get the feeling that, as far as Dr Snell is concerned, it's all a work-in-progress.
    He seems to be exploring this area of research to find the best tests.
    Valentijn likes this.
  7. Bob

    Bob

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    Regarding Beth Under in this CFSAC video:


    It's just my own interpretation, and I may well change my mind, but I am encouraged by Beth Unger's attitude.
    I wasn't encouraged to begin with, but I've watched parts of the video a few times now, and my perception has changed.
    She isn't quite where we want her to be, but I believe she is moving in the right direction.

    Some of the CFSAC members' have consistently complained about content on the CDC's websites, and their approach to diagnostic criteria and education. (And I agree with them.)

    But in terms of the research that Unger is carrying out (apart from not yet incorporating two-day exercise tests - which she hasn't ruled out), much of what Unger says in the CFSAC video, in relation to the research she is carrying out, gives me cause for hope that she is taking ME seriously, and has sort of rebooted the CDC's approach to ME, starting afresh with collecting the empirical data. (Something that should have been done 30 years ago.)

    She acknowledges the severity of the illness, she acknowledges the physiological changes, she acknowledges the complexity of the illness, and the unhelpful heterogeneity of the CFS criteria. And she gives no hint that ME is anything other than a serious and debilitating biomedical illness.

    She says that the more symptoms someone has, the greater the severity, or vice-verse. (In other words there is a correlation between severity and the number of symptoms.) (This seems like a helpful insight, and is miles away from the psycho-social model.)

    She seems to recognise that heterogeneity is the biggest problem. And she's looking for data to find well-defined subsets. That's her mission. And I think it's the correct and best mission for her to be engaged in. I think it's exactly what the CDC should be doing, as long as they do it properly.

    She's not overly keen on promoting the CCC, although perhaps the CDC do seem to be moving towards it, slowly, but she also acknowledges that Fukuda is inadequate, and that's why she's working towards new criteria, looking for empirical evidence to find well defined subsets of patients.

    She says that in the long term, none of the diagnostic criteria will be perfect, and she is looking towards defining subsets by looking at treatments, and finding out the differences between the patients who respond and those who don't respond. She gave Ampligen as an example of where some patients respond to treatment and others don't.
    She says that finding out why some patients respond to treatments (what it different about them - are there any biomarkers) will probably prove to be the best way forwards in terms of defining the disease. I think she's spot on.

    In the video, they have a discussion about post-exertional malaise (which Unger helpfully said is not a very helpful description, and that post-exertional exacerbation, or post-exertional relapse might be better), and that seems to be one of her focuses in her study. She is aware that this might prove to be a way to define a subset, and she is aware that some experts say that this is a defining feature of ME. She's proactively looking at the related data in her study.

    I wasn't too hopeful about Unger for a long time, but I think she is actually beginning to 'get it'... i.e. to understand the nature of the illness from the patients' point of view, and what needs to be done to understand it from a scientific point of view. And she seems receptive to suggestions and input from the CFSAC meeting. There's a long way to go, but I'm encouraged.

    I might be wrong about it all, but that's the feeling I get from listening to her.
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  8. Bob

    Bob

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    A few more details about the CDC study.

    Stage 2 of Multi-site CFS Study.

    Follow-up of CFS patients enrolled in Stage 1.
    - Saliva for morning cortisol profile.
    - Blood for DNA and RNA


    Details taken from this video:
  9. Valentijn

    Valentijn Activity Level: 3

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    Actually this does fit into the BPS models. Many believe that the more unexplained somatic symptoms someone has, the worse their presumed psychosomatic disorder is.
    Bob likes this.
  10. Bob

    Bob

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    Oh yes, that's right. Thanks for spotting that. But Unger was referring to her data, so she's not basing her assertion on a hypothesis. I got muddled about that because someone else on the committee panel (Fred Friedberg?) mentioned (@0.28.30) that the ICC selects for 'psychiatric disorder' at a high rate (he didn't use the term 'comorbidity') (perhaps he was referring to Jason's recent small study), and suggested a qualitative approach to diagnosis using fewer symptoms for a diagnosis. Unger said she remained committed to the data, but would prefer a simple diagnostic criteria if the data allows. She was very clear that she is purely being driven by the data. She seems to be approaching the illness afresh, with an empty slate. For example, when asked about post-exertional malaise, and if she is agnostic about its importance, she said that she will let the data decide, but that she will certainly pro-actively analyse the data with a view to evaluating the significance of PEM and attempting to determine subsets based on PEM.
    (I'm paraphrasing to the best of my memory and understanding. Some of this discussion is roughly @0.28.00 in the video.)
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  11. Bob

    Bob

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    A new 'expert' working group is being set up by the NIH as the start of a new project to scientifically analyse all the research data, with a view to assessing the current diagnostic definitions. They want to find out where the strengths and weaknesses of each set of criteria lay. It seems like a very big project. Details of the working group will be posted online when available.

    Details about the working group for the NIH's diagnostic criteria research review will be published here, when available:
    http://www.effectivehealthcare.ahrq.gov/
  12. Firestormm

    Firestormm Guest

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    Bob my friend - you should write an article. You must have analysed this meeting so much by now. Thanks for the links. I was listening to them myself this morning whilst playing minecraft. Hard to follow I felt. An article might be nice - assuming one hasn't already been done that focuses explicitly on these points :)
  13. Bob

    Bob

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    Thanks Firestormm. Yes, there is a lot of information. (I had to watch the videos without multitasking to make sense of them.)

    I've scrutinised some of the videos because the CDC, FDA and NIH seem to be starting some very interesting projects.
    There is quite a lot going on, and CFS seems to have been prioritised within the NIH.
    CFS seems to have been placed at the top of a priority list, and many different health departments seem to be getting involved.

    But I still haven't quite grasped what's going on, so I couldn't write an article.
    (I'd quite like it if someone else could explain it all to me!)
    (I also don't understand how the various US health departments relate to each other, so it can be a bit confusing to understand exactly who's doing what.)

    The CDC study seems to be evolving, and I think that Beth Unger is open minded about where it will lead, and what tests will eventually be involved. They are already taking the study to a new level, and taking DNA/RNA samples, and testing for morning cortisol levels. And also doing cardiopulmonary testing during exercise tests, and cognitive testing post-exercise. A number of members at the CFSAC meeting were urging Unger to meet Dr Snell, and she was taking notes, so hopefully she will meet him, in which case she might end up including two-day anaerobic threshold tests. Let's hope so. She's already hinted that she may well include post-exertion resting heart rate tests, which the committee panel urged her to do.

    The NIH (or FDA? or both?) is setting up a parallel study which aims to analyse the existing research data (in relation to assessing all the current diagnostic criteria), with a view to assessing the strengths and weaknesses of each set of criteria, and with a view to finding out where the gaps in the knowledge are, and what future research is needed to fill those gaps.
    The project is being set up with help from ME patients, ME advocates, ME organisations, and ME experts, to form a working group which will guide the scientific group who are analysing the data. It was explained that the working group will form the questions that the scientific group will aim to answer. And the details of the working group and their 'questions' will be placed online.

    It's an interesting project, and financial resources have been committed to it. I think its success all depends on the working group that is being set up. Some of the CFSAC committee members are on the working group, and it seems that some well-known patients are included, but details were not given. I thnk they said that the project is starting late June to early July. (So that's about now.)

    The NIH representative (Susan Maier - Deputy Director, Office of Research on Women's Health) also mentioned funding for CFS research, and encouraged people to apply for grants, and suggested that the amount of money available for CFS research has been increased, but I don't think she gave exact details of available funding.
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  14. Ember

    Ember Senior Member

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    According to the Assistant Secretary, the NIH EbMW
    How many clinical research outcomes (using which research case definitions) can they be expecting to review and compare?

    A researcher herself, Dr. Fletcher reminded CFSAC, “We wanted to have a meeting of experts, advocates and clinicians to meet together and that we would take as a basis of starting the international case definition...2003. That was all specifically spelled out in our resolution. This substitution is just totally unacceptable.”
  15. Ember

    Ember Senior Member

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    Dr. Unger seems to be good at turning a deaf ear whenever it suits her. At the Ottawa conference in September 2011, she spoke after Dr. Carruthers during the “Case Definitions for Research and Practice” session. And at the FDA workshop in April of this year, she spoke after Dr. Snell on the “CFS and ME Clinical Trial Endpoints and Design” panel.

    Dr. Carruthers concluded his presentation this way: “As Osler also said, 'Listen to your patients. They are giving you the diagnosis'. Now we have the technology to confirm this directly for this complex disease– if we use it.” Dr. Snell concluded his FDA presentation, “A single exercise test may be insufficient to distinguish between CFS/ME and sedentary controls.”

    The question isn't so much whether Dr. Unger gets it, but whether she'll act on it.
  16. Bob

    Bob

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    I think it's a process for her. I agree that she's been slow, and I am cautious about praising her prematurely. But she seems to be collaborating with the ME community and she seems to be listening. The changes that she is incorporating into her study suggests that she is beginning to 'act'. And her comments at the CFSAC meeting suggest that she is receptive, for example, her apparent willingness to incorporate post-exertion resting heart-rate into the study, as recommended to her. It's too early to know if she will make a difference. But I don't think it's all bad at the CDC at the moment. There seems to have been a major change, and perhaps the pace of change is increasing.
  17. Bob

    Bob

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    I'm not particularly optimistic about this review. Reviews tend to be conservative, too narrowly focused, and short-sighted. And nearly all the literature is based only on Fukuda. However, there is a possibility that they will conclude that Fukuda is too inclusive (not specific enough), which would be helpful. Jason has published papers about this, and perhaps they might use that sort of research for some of their conclusions.

    I think that the outcome of the review might depend a lot on the working group. (It's a shame that the creation of the working group was not a transparent process, but I hope that it will mostly involve individuals whom we approve of, as it seems to have come off the back of the FDA stakeholder meeting.) If the working group set the right agenda, and ask the right questions, then the systematic review just might come up with some answers/proposals/suggestion that we find acceptable and helpful.

    Like I said, I'm not particularly optimistic about this process.
  18. Ember

    Ember Senior Member

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    The CDC cannot plead ignorance. As Chris Cairns wrote of the FDA, they should “fish or cut bait. After this two-day FDA conference on April 25th and 26th, [they] can no longer plead ignorance about the true nature of this illness.”
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  19. PhoenixDown

    PhoenixDown Senior Member

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    http://www.scmp.com/lifestyle/health/article/1143171/daze-their-lives

    Wasn't sure which thread to place this, 10.7%, when I hear numbers like that I just know it's going to cause credibility problems. The article states that CFS is interchangeable with ME so 10.7% of people have ME.
  20. Ember

    Ember Senior Member

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    As Doogle notes here, the author is confused.

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