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Responses to individual points in the P2P report

Discussion in 'Advocacy Projects' started by Sasha, Dec 28, 2014.

  1. Sasha

    Sasha Fine, thank you

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    About this thread

    On the main P2P thread, I listed points that we might like to write in about, both to praise what we like and to get changed those things that we don't.

    This is a resource-only thread to support that effort. Please don't post discussion here - that's for the main thread.

    Please only post here if you've adopted a particular point: your should only make one post about that point, in the format described below. You can always edit it later if the material is incomplete.

    The idea is that anyone can come to this thread and see a single post - not a series by different people - that pulls together what they need to respond to any one of the main points in relation to the P2P draft.

    The format should be as in the fourth post on this thread, where I give an example. That is:

    (a) the specific recommendation that we're making, in bold;

    (b) the line numbers where the key text occurs in the draft report, with it quoted;

    (c) any relevant facts,citations and/or key arguments.
    Edit: My line numbers are based on the 403-line version of the document.
     
    Last edited: Jan 7, 2015
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  2. Sasha

    Sasha Fine, thank you

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    Key points

    Things to praise:

    Listed here.

    Points of criticism:

    1. The report’s estimate of the annual economic burden of ME/CFS in the US of approx. $1 billion should be corrected to its true figure of well over $19 billion. [here]

    2. The report should call for the NIH to fund biomedical research into ME/CFS with an budget commensurate with the burden of the disease, of at least $287 million a year. [here]

    3. [deleted]

    4. Given that the report recommends the retirement of the Oxford criteria, the PACE trial and all other Oxford-criteria trials should be excluded from the report. [here]

    5. References to patients’ ‘fear’ should be removed from the report. [here]

    6. Further research into psychological aspects of, and treatments for ME/CFS should not be conducted, and psychological therapies should not be recommended as a standard part of treatment [here]

    7. Recommendations for treatment teams should focus on the role of specialist physicians, not psychologists and others [here]

    8. Studies investigating homeopathy for ME/CFS should not be conducted, and studies of complementary and alternative medicine should receive very low priority. [here]
     
    Last edited: Jan 5, 2015
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  3. Sasha

    Sasha Fine, thank you

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    Resources

    Deadline for response: 16 January.

    The NIH response instructions are to "please reference the corresponding line number of the report", and submit your comments via prevention@mail.nih.gov or postal mail to:

    Office of Disease Prevention
    National Institutes of Health
    ATTN: Paris A. Watson
    6100 Executive Boulevard, Suite 2B03
    Bethesda, MD 20892

    The report: https://prevention.nih.gov/docs/programs/mecfs/ODP-MECFS-DraftReport.pdf

    Sean's post with his very helpful plain-text file of the report: http://forums.phoenixrising.me/inde...draft-report-is-out.34480/page-16#post-537739

    Day 1 P2P workshop videocast: http://videocast.nih.gov/summary.asp?live=14723&bhcp=1

    Day 2 videocast: http://videocast.nih.gov/Summary.asp?File=18775&bhcp=1

    Day 1 captions: http://videocast.nih.gov/vodCaptions/mecfs120914.txt

    Day 2 captions: http://videocast.nih.gov/vodCaptions/mecfs121014.txt

    Day 1 & 2 agenda: https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/me-cfs/agenda

    @Sing kindly provided this list of posts from the main thread which could offer specific help for commenting. They include line numbers and/or quotes, and reference materials but not analysis (which would be worth reading).

    Ecoclimber post 7
    Bob " 14, 16,18
    jmells " 26
    Wildcat " 67, 75
    Bob " 83, 93
    Nielk " 96, 110
    Sasha " 99
    Ecoclimber " 123
    Nielk " 124,127
    Bob " 134,147
    alex3619 " 165
    sidereal " 173
    Ecoclimber " 177
    Hope123 " 186
    taniaaust1 " 215
    Ember " 250,306
    Ecoclimber " 307
    Ember " 317
    Nielk " 358
    Sasha " 368, 372, 378
    Bob " 387
    Valentijn " 395
    Ember " 401
    Anne " 440, 446
    biophile " 461
    Ember " 469
     
    Last edited: Jan 1, 2015
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  4. Sasha

    Sasha Fine, thank you

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    Criticism #1

    The report’s estimate of the annual economic burden of ME/CFS in the US of approx. $1 billion should be corrected to its true figure of well over $19 billion.

    The report states:

    [Lines 6-7] ME/CFS is an unmet public health need with an economic burden estimated to be greater than $1 billion.​

    This appears to be based on an incorrect and unsubstantiated statement made by the workshop facilitator, Dr Carmen Green, during her introductory statement at the P2P workshop on 9 December (“As you have heard, ME/CFS is a major health issue for over one million adults, has an economic burden associated with $1 billion”).

    In fact, the latest research on economic burden is a 2008 paper by Jason et al. (The economic impact of ME/CFS: individual and societal costs. Jason LA, Benton MC, Valentine L, Johnson A, Torres-Harding S. Dynamic Medicine 2008, 7:6, available at http://www.dynamic-med.com/content/7/1/6).

    Using a community-based sample of patients, he estimated economic burden at $18.7 billion; using a tertiary sample, the estimate was $24.0 billion.

    Adjusted for 2015, the sums would of course be even higher.

    *********************************

    [Note: there's a Georgia-based CDC study of economic burden but it's based on a ridiculously high (CDC) prevalence estimate of 4 million PWCFS in the US so I'm ignoring it.]

    These are the facts on which anyone might base this point: anyone can rewrite this how they like and use it.
     
    Last edited: Jan 1, 2015
  5. Sing

    Sing Senior Member

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    I don't know how to copy and move posts from the other thread or if that would be okay from me, but I have read/skimmed through the whole other thread and came up with this list of posts which could offer specific help for commenting. They include line numbers and/or quotes, also reference materials. For the purpose of this thread, I have left aside all the good discussion and analysis, which I feel are worth revisiting before sending your letter. Maybe someone who knows how to copy and move posts could do these, while being a second set of eyes to see if you think they all could offer some specific help for our letters.

    Ecoclimber post 7
    Bob " 14, 16,18
    jmells " 26
    Wildcat " 67, 75
    Bob " 83, 93
    Nielk " 96, 110
    Sasha " 99
    Ecoclimber " 123
    Nielk " 124,127
    Bob " 134,147
    alex3619 " 165
    sidereal " 173
    Ecoclimber " 177
    Hope123 " 186
    taniaaust1 " 215
    Ember " 250,306
    Ecoclimber " 307
    Ember " 317
    Nielk " 358
    Sasha " 368, 372, 378
    Bob " 387
    Valentijn " 395
    Ember " 401
    Anne " 440, 446
    biophile " 461
    Ember " 469
     
  6. Sing

    Sing Senior Member

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    @Sasha I am thinking that the people who wrote the posts on my list above could re-post them here--unless, of course, they want to revise them in some way. Do you know how people can move their posts and if so, would you describe this?
     
    Last edited: Dec 29, 2014
  7. Snow Leopard

    Snow Leopard Hibernating

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    The two above estimates are effectively based off the Wichita and Chicago population community based studies.

    I think it is worth mentioning the Georgia study, just to say that a looser definition of CFS shows even higher economic costs. Nationally, it was around $51 billion (2011 est).
     
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  8. Sasha

    Sasha Fine, thank you

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    People seem to be struggling with the idea of not discussing these points here on this thread so OK, go for it! I can always create another repository thread later.
     
  9. Sasha

    Sasha Fine, thank you

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    Actually, Sing, I think we might end up with another out-of-control thread that's stuffed with posts and doesn't get any work done. I think this is only going to work if people take ownership of particular points and do any necessary research (including looking through that thread, if appropriate).

    I'm already wondering if I have asked too much of people! :eek:

    Thanks for your enthusiasm, though! Is there a particular point you fancy tackling (but seriously, no pressure!).
     
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  10. Sasha

    Sasha Fine, thank you

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    Criticism #8

    Studies investigating homeopathy for ME/CFS should not be conducted, and studies of complementary and alternative medicine should receive very low priority.


    [lines 278-282] Patients often choose clinical trials or complementary and alternative medicine because effective treatment is not available and because traditional health care is not meeting their needs. Studies investigating homeopathy, non-pharmacologic, complementary, and alternative medicine treatments are needed.​

    The NIH’s own National Centre for Complementary and Alternative Medicine webpage on homeopathy states, “There is little evidence to support homeopathy as an effective treatment for any specific condition” and “Several key concepts of homeopathy are inconsistent with fundamental concepts of chemistry and physics.” (http://nccam.nih.gov/health/homeopathy)

    As the report states, patients often choose ‘alternative’ treatments because there is no effective conventional treatment. The remedy should be to focus on providing effective conventional medical treatment based on serious biomedical research, not to spend more on researching complementary therapies of last resort.

    In particular, for the NIH, via the P2P report, to suggest spending scarce research dollars on homeopathy is to suggest that a therapy that its own agency considers ineffective and scientifically baseless is suitable for ME/CFS. This is an insult to patients.

    Such research would further stigmatise the condition: any disease that the NIH believes can be cured by chalk pills would be perceived to be all in the mind.
     
    Last edited: Jan 1, 2015
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  11. Sasha

    Sasha Fine, thank you

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    Criticism #2

    The report should call for the NIH to fund biomedical research into ME/CFS with an budget commensurate with the burden of the disease, of at least $287 million a year.

    [Lines 5-9] An estimated one million people, mostly women, are affected. ME/CFS is an unmet public health need with an economic burden estimated to be greater than $1 billion. ME/CFS results in major disability for a large proportion of the people affected. Limited knowledge and research funding creates an additional burden for patients and health care providers.

    [Lines 213-221] Investing in bench-to-bedside to policy research for ME/CFS is recommended [...] The NIH Institutes and Centers [...] and other U.S. Department of Health and Human Services (HHS) agencies should coordinate research efforts to promote efficiency and effectiveness, while also using public/private partnerships to leverage and catalyze the use of existing NIH infrastructure and dollars.

    [Lines 390-391] There is a role for new and ongoing policies to spark innovation and fund new research. For instance, new avenues are needed to fund research, such as the Prescription Drug User Fee Act.​

    The report (lines 5-9) acknowledges that an estimated one million people in the US have ME/CFS and that it results in major disability for a large proportion of those affected. According to the UK Department of Health, "Estimates suggest that up to 25% of people with CFS/ME are so seriously affected that they are unable to perform most basic personal tasks and are confined to bed or spend the majority of the day in bed.”

    http://webarchive.nationalarchives....@dh/@en/documents/digitalasset/dh_4064945.pdf

    The estimated cost to the US is not $1 billion as stated in lines 5-9, but over $19 billion (The economic impact of ME/CFS: individual and societal costs. Jason LA, Benton MC, Valentine L, Johnson A, Torres-Harding S. Dynamic Medicine 2008, 7:6, available athttp://www.dynamic-med.com/content/7/1/6).

    Despite this disease burden upon patients and economic burden on society, the NIH spends an average of $5 million a year and ME/CFS is 229th out of 237 ailments on NIH’s grant list, in terms of funds allocated.

    http://report.nih.gov/categorical_spending.aspx

    MS has a similar disability profile to ME/CFS but affects only 4 people for every 10 with ME/CFS. Nevertheless, it typically receives about $115 million in annual NIH research funding: so in proportion, MS receives roughly 60 times as much funding as ME/CFS.

    The report must call upon ME/CFS to have approximate pro-rata research parity with MS, which would be an annual budget of $287 million.

    Although the NIH’s budget has been cut in recent years, this is irrelevant. Other diseases must forego a tiny fraction of their research income so that ME/CFS can have its decades-overdue fair cut of the total NIH pot. Immediate fair redistribution is essential.

    The report as it stands does not mention direct NIH funding (lines 213-221 and 390-391). This must be changed.
     
    Last edited: Jan 5, 2015
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  12. Sasha

    Sasha Fine, thank you

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    Criticism #4

    Given that the report recommends the retirement of the Oxford criteria, the PACE trial and all other Oxford-criteria trials should be excluded from the report.

    [Lines 38-43] The Oxford criteria (published in the Journal of the Royal Society of Medicine in February 1991) are flawed and include people with other conditions, confounding the ability to interpret the science. The lack of a consistent, specific, sensitive diagnostic test and set of criteria has hampered all downstream research on pathogenesis and treatment, causing harm and preventing ME/CFS from being considered as a distinct pathologic entity.

    [Lines 378-380] Specifically, continuing to use the Oxford definition may impair progress and cause harm. Thus, for needed progress to occur we recommend (1) that the Oxford definition be retired [...]​

    It is good to see that the report recommends that the Oxford definition of ME/CFS be retired and recognises the damage that it has done to research.

    That said, it makes no sense for the report to reject the Oxford definition so strongly and yet include Oxford-definition trials, including the PACE trial, when assessing the efficacy of cognitive behavioural therapy (CBT) and graded exercise therapy (GET).

    The report states (lines 108 and 113-114) that “Patients with ME/CFS are hopeful that research will lead to a cure [...] Existing treatment studies (cognitive behavioural therapy [CBT] and graded exercise therapy [GET]) demonstrate measurable improvement”. This is seriously misleading: it gives the impression that the CBT/GET studies assessed were studies on ME/CFS patients, and conflicts with the acknowledgement in lines 38-39 that the criteria are flawed and include people with other conditions.

    Meta-analyses of ‘ME/CFS’ CBT and GET studies are presented in the recent AHRQ report (pp. 44, 59, and 60, with the diagnostic inclusion criteria listed on the pages that follow):

    http://www.effectivehealthcare.ahrq.gov/ehc/products/586/2004/chronic-fatigue-report-141209.pdf

    When the Oxford-definition studies are removed, the remaining CBT studies are a failure and the single remaining GET study only barely reaches statistical significance. Given that it included only 25 patients and, by its nature, could not be blinded, its results are extremely weak.

    Please note that although data were collected in relation to Fukuda symptoms, it is not the case that a subset of Fukuda-criteria patients can be identified. Patients were asked about Fukuda criteria only in relation to the past week, not the required six months (p. 156 in this document: http://www.meactionuk.org.uk/FULL-Protocol-SEARCHABLE-version.pdf and in the ‘CFS case definition: the International (Centers for Disease Control and Prevention, CDC) criteria’ section of this document: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3776285/.

    It is important to make it clear in lines 113-114 that CBT and GET studies on ME/CFS patients do not demonstrate measurable improvement.
     
    Last edited: Jan 7, 2015
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  13. Sasha

    Sasha Fine, thank you

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    BTW, I doubt that everyone needs to give quite so much detail when they write - but I want in these posts to make fairly full information readily available if I can, for those who want it.

    At the very least, I hope it's helpful to have the sections of the report that most of us will want to critique given here in an easy format to read, and to copy and paste.

    Even if all you can do when you write is to be very brief - to say, for example, 'don't use Oxford-based trials - it's just nuts, given that you want the criteria retired' - that will be a help! Because it is nuts, quite frankly, and the point stands quite well on its own without too much back-up.

    The same is likely true of other points.

    The main thing is to write in about what you think is important.

    More coming up later. :)
     
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  14. Nielk

    Nielk

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    As they have stated at the workshop when replying to Jennie Spotila's question, they cannot delete the Oxford Criteria from the report because it was part of the parameters of the evidence study. For them to do that, they would have to re-do the entire evidence search.
     
  15. Sasha

    Sasha Fine, thank you

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    Well, that's what that researcher said but it seems like a total failure of logic to me not to live by their own strong recommendation about Oxford and I think we need to point that out. I simply don't accept their argument.
     
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  16. Nielk

    Nielk

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    If they agree to leave the PACE trial out because they used the Oxford criteria, they will have to do the same for all studies that used the Oxford criteria.
     
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  17. Sasha

    Sasha Fine, thank you

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    Things to praise in the report

    Here's a selection, with line numbers. We can be pleased that the report
    • recommends that the Oxford criteria for ME/CFS be retired (line 38).
    • recognises the scale and severity of the problem that ME/CFS presents, both to patients and the US economy (line ??)
    • recognises that innovative biomedical research is urgently needed (line 186)
    • spells out the biomedical research that is needed, from the development of biomarkers to the collection of biobank materials to 'omics'-based drug repurposing (lines 222-276)
    • recognises the importance of telemedicine for housebound/bedbound patients (line 303)
    • emphasises the need to address issues that are meaningful to patients (lines 80-81)
    There are more than this and you may have your favourites but it's polite to grab a handful and mention some before you start criticising things! :cool:
     
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  18. Sasha

    Sasha Fine, thank you

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    I agree - I looked at the meta-analyses, which listed studies by criteria, and I've already edited that into my post above.
     
  19. Bob

    Bob

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    Hi Sasha, I can delete this post after you've considered it. Oxford are a broad/inclusive set of criteria that simply diagnoses "chronic fatigue" (no other symptoms required.) Would you also be able to include a comment about removing research evidence that was based on a general 'chronic fatigue' recruitment criteria (i.e. equivalent to Oxford) whether Oxford was used or not? I think a lot of CBT/GET research might be based on recruitment criteria that simply required chronic fatigue for a period of time. They don't all use Oxford.
     
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  20. Sean

    Sean Senior Member

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    This contradiction is a major problem for the report, that goes to the heart of a lot of the trouble in this field, and the report authors need to be pushed hard to satisfactorily resolve it.

    Logic demands it, whatever their terms of reference say.
     
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