P2P Report: First Read

The P2P Panel’s draft report on advancing ME/CFS research has been published. The report is not the nightmare that many people feared, but it is also not what I had hoped for or what we need.

The advocacy chatter I’ve seen in the last 12 hours (and I have not seen everything) has been overwhelmingly positive. Words like “superb” and “justice” have been used, and it is true that there is much in the report that validates what ME/CFS experts and advocates have been saying for years.

I am in the “bah, humbug” minority, though. While there are strong recommendations in the report, many things that I considered essential for success are missing.  For example, the Panel does not seem to have understood post-exertional malaise, how it is distinguishable from fatigue, and the data that show how essential it is to understanding this disease. I don’t blame the Panel for this oversight, necessarily. Given the evidence review and the agenda of the Workshop, they were not presented with much of that data. This is the Achilles heel I’ve been pointing to all year: that the Panel would not be shown the full ME/CFS landscape and therefore, their attempt to chart a course through that landscape would suffer.

There are a number of ME/CFS advocates who believe that NIH does not want to fund research on this disease. Setting aside whether that is true and the accuracy of the alleged reasons for it, the draft Panel report will not solve the problem. Perhaps it’s my legal training, but when I read this draft report I see so many loopholes. If I were NIH and I did not want to increase funding for ME/CFS research or change the institutional approaches to the disease, then I would scan this report looking for ways to continue that policy. I would look for recommendations that I could accomplish at little or no cost, and I would focus on those. Then I could report to the CFS Advisory Committee or Congress that I was making tremendous progress on the recommendations, without actually changing the basic fundamental problem: grossly inadequate funding that is disproportionate to the burden of ME/CFS. From that point of view, this draft report offers many opportunities that NIH could exploit.

I won’t be able to post more detailed comments until after the holidays, but that is where you come in, too. We have until January 16, 2015 to submit comments on the draft report to NIH. After that, the Panel will review all the comments and finalize the report. Instructions for submitting comments are here, and be sure to follow those instructions when you comment.

To the extent that the Panel got things right, it is a direct result of the participation of ME/CFS experts and advocates. The draft evidence review was a disaster, and some of the Workshop presentations fell short. If you watched the Workshop, then you will recognize its impact on the draft. For example, Dr. Hornig’s presentation on the microbiome was obviously persuasive to the Panel. And the patients who spoke at the meeting or submitted comments online were the only source of information for the Panel on the devastating impact of this disease.

If you want NIH to carry on as it has thus far or if you think this report is superb as it is, then you may not see a need to comment. But if you see any flaws in this report, or loopholes that will perpetuate what has been done (and not done) for decades, then you MUST comment on the report. If you think this whole process is illegitimate, or you think the Panel should be recommending adoption of the Canadian Criteria, then submit comments on the report. That is the only way you will be heard by the Panel.

We’ve already seen the impact that the experts and advocates have had thus far by speaking out. Please join us, and tell the Panel what you think of this report.

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38 Responses to P2P Report: First Read

  1. Roy says:

    I have to confess to some initial overly optimistic thoughts from the triumph of low expectations for this whole process. (and with my background there is no excuse for that)

    However, there is a big problem simply recommending CBT, at least in the United States. In the real world patients run a risk of getting something else as described in this article:


    There is also a very real possibility for psychological harm that may be serious and permanent which is discussed in this previous thread:


    It doesn’t appear that any of the NIH ME CFS P2P panel members have knowledge of real world clinical psychology.

    Kathleen M. O’Neil, Penney Cowan, Carmen R. Green, Ronit Elk, Angela L. Rasmussen

  2. Mary Dimmock says:

    Thank you for this, Jennie.

    I agree with you. You could drive a truck through the loopholes in this report.

    My most fundamental concern is the continued lack of clarity on the disease to which this report applies. The report does not state that hallmark criteria like PEM must be mandatory, only that PEM should be studied further. The report recommends against Oxford but says nothing of Fukuda’s failure to require hallmark criteria or its lack of specificity as Nacul and Jason discussed in their presentations.

    So what disease does this report refer to? The disease described by the CCC and the ME-ICC? Or the 163 possible different combinations of Fukuda symptoms that Dr. Nacul spoke to – of which only a small portion required PEM.

    As written, this report could be read to apply to ME. Or it could be read to apply to the broader scope of disparate conditions encompassed by Fukuda. That lack of clarity on the scope of this disease is the root cause of the lack of progress and needs to be addressed. Implementing this report without doing so is wasteful and worse, is bad science.

    The other big issue is the failure to explicitly call for NIH to increase the level of funding to be commensurate with the burden of disease. The report’s funding recommendations were process oriented and/or focused on encouraging public-private collaborations or getting industry involved. But those mechanisms are not enough to overcome NIH’s failure to provide an adequate level of direct funding for basic research, funding that is the engine of both public-private collaborations and industry investment. And those recommendations are not enough to overcome the unique issues ME faces because none of the NIH institutes have stepped up to declare a strategic interest in this disease.

    • mjill says:

      Mary, thank you for putting into words what my foggy brain could not. I agree with your comment 100%.

    • Gabby says:

      Very well stated, Mary.

      The fault lies with the parameters of the p2p process. As advocates have been warning about this from the start. No wonder the resulting report is so vague, murky and meaningless.
      As soon as NIH took out the most important question of separating ME from CFS, this work was doomed.
      In addition, by lumping all criteria, as if they are all equally valid was the stamp that insured failure.
      This report has been sugarcoated in favor of patients’ validations order to ensure acceptance.

      They have thrown in words such as;

      ME/CFS exists – It is not psychological – Patients concerns need to be heard – There is a lack of informed clinicians- Patients are labeled lazy and deconditioned – It has debilitating effects on patients – the need to hear the patients’ voice.

      What the report is actually (falsely) stating;

      There is a lack of a universally accepted case definition – Not true, we have the Canadian Consensus Criteria (CCC) universally accepted by experts, clinicians, researchers, CFSAC members, advocates and patients.

      There is a co-morbidity of major depressive disorders – based on what?

      PEM is one of many possible symptoms – PEM is the hallmark symptom

      They recommend education to patients for “self management”, like understanding emotions. Are they serious???

      They recommend graded exercise – warning that patients need to be properly instructed and guided – with the lack thereof creates fear of harm. (Meaning, it is not the actual action that is harmful but the fear of it)

      There is a need for training and education for primary care clinicians – they do not recommend a specialty to take us on. “a team of primary care clinicians, nurses, case managers, social workers, psychologists” – no mention of neurologist, immunologist, rheumatologist..etc

      They recommend studying the benefits of CBT along with multimodal therapies. – MMT is a type of psychotherapy.

      In conclusion, the report recommends larger, more comprehensive studies in order to better understand the pathogenesis of the disease with the hope of finding biomarkers and treatments.

      This leaves me to my question – How binding is this report? Will it collect dust along with all CFSAC recommendations that have been either ignored or denied? The last two recommendations issued by CFSAC have recieved a letter of denial by Sylvia Burwell, stating that NIH has no funds for them.

      In what way, will this report be different?

      On the NIH site for P2P, they state:

      “The information in this report is intended to help health care decision-makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services.”

      What do they mean by “health system leaders”? Does this mean “insurance companies? How will this effect us?

      My short take on reading this report?

      They state that ME/CFS exists. We are not sure what it is and how to diagnose it. There is no way of testing for it and there are no treatments or ways to help patients. We should teach this ignorance to clinicians, nurses, social workers, psychologists. Patients should take the responsibility to get psychoanalysis. NIH should spend money that they don’t have on further, larger, deeper research in the disease which exists.

    • Gabby says:

      I just wanted to add that apparently this panel does not know the existence of, or never readr the International Consensus Primer for Medical Practitioners.

      • Jennie Spotila says:

        Actually, Mary Dimmock distributed a Primer (although I don’t remember which one) to the Panel at the meeting.

  3. Robert Miller says:

    Hi Jennie,Thanks for attending the P2P.
    The panel makes direct points re: post-exertion malaise on lines 58-59,105-107 of the Report. (See below): This is why I believe Patients, Advocates and Advocate groups should discuss the Draft Report before making comments. This Report is a Guide for NIH and HHS to get it right, they asked for the input. Just as a parent or friend would use the proper tone and language to help guide their child or friend to do the right thing, we can also use those tools to Guide the Panel in the Final Report. As a patient, I know that I miss things (brain fog), if we work together we can make recommendations that will clarify the Report and not water it down. As patients I believe that if we are honest with ourselves, we would say we expected this report to be a disaster, it is Not. We should acknowledge that fact. Some of the people working for our benefit on our behalf are at NIH and HHS, just as HIV/AIDS Activist sat down with these organizations after getting their attention by Acting-Up, we need to do the same. I’m not saying we need to be BFF, but we need to work with them, just as our expert ME/CFS researchers and clinicians have done. There is a balance.

    From Draft Report:
    58- Fatigue has been the defining focus of recent research, but many other symptoms need to be
    59- explored, primarily neurocognitive deficit (“brain fog”), post-exertion malaise,
    and pain.
    105-A clear case definition with validated diagnostic tools is required before
    106- studies can be conducted. We noted a consistent constellation of symptoms: fatigue, post-
    107- exertional malaise, neurocognitive deficit, and pain.

    • Jennie Spotila says:

      I agree with telling people when they have gotten something right. I also agree with pointing out when they get it wrong. These are not contradictory positions.

      I am regularly accused of collaborating with the government and/or perceived enemies of the patient population. Last month, I was accused of accepting bribes to push the government’s agenda. Today I have been accused (in several places) of finding unreasonable fault with this report out of an overabundance of negativity. I am choosing to see these inherently contradictory accusations as reflective of the accusers’ views relative to my own, rather than a realistic reflection of my own advocacy.

      I will continue to honestly and respectfully speak my mind. I encourage all advocates to speak their own minds honestly and respectfully, whether or not they agree with me.

      • Kati D says:

        Jennie you are doing great. Keep on doing exactly what uou are doing.

        And i very much agree there are major loopholes in this report. There is no mention of the CCC. For all we know they could decide on usimg Fukida even if it’s not perfect. The mention of CBT and multidiciplinary team (in my view, we need virologists, immunologists, scientists likeLipkin and Hornig, and not the kind that want to investigate whether napping 3 times daily improves fatigue.
        The co-morbid conditions are major loopholes because they are vague and poorly defined and oftentimes stigmatized as well, it leads nowhere to research vulvodynia (for instance) and how it relates to ME.

        Lumping few vague conditions together will not makes ours clearer.

        Then there is the issue of studying men with ME as a minority group. Being part of the Office Of Women’s health at NIH has served nothing, and as ammostly women’s disease, we are suffering the stigma, but it does not mean to stop researching womens and focus on me with ME. it is so messed up.

        This report makes no promises of funding nor makes recommendations of increasing research funding. For all we know NIH could decide to replicate PACE using a different criteria (shudder).

        Loopholes it is. i feel this report was expedited and wording suffers, which implies patients will pay the price.

      • Magdalena says:

        “I will continue to honestly and respectfully speak my mind.”
        yes! <3 thank you, you are doing amazing!

    • jimells says:

      Where’s the money? There’s no discussion of funding. There’s no discussion of why there has been no funding. Everything else is just rearranging deck chairs on the Titanic.

      I have seen no indication that NIH is going to change this. There is every indication that they will continue to deny funding, such as the latest official response to the CFSAC recommendations. The abusive treatment of Jeanette Burmeister (which continues to this day) re the FOIA suits indicates NIH has not changed their hostile attitude.

      As I recall Jennie Spotila has also suffered as a result of her advocacy on our behalf, but my brain’s not working today so I can’t recall the details.

      Without funding this report is just a sugar pill.

      I agree with Jennie. Bah Humbug, indeed!

  4. Robert Miller says:

    Jennie, It is my belief that the Panel and Chair would appreciate input that confirms what they got right and what they got wrong or needs more detailed attention. As for personal attacks on anyone who is and has been trying to move us forward, that is just uncalled for. It takes a lot of energy to Advocate for our patient population. I would ask that people use their energy for something much more productive. We may not always agree, but I appreciate and respect your efforts. I hope all Patients and Advocates will comment. As I stated prior, I believe the Panel did a good job, that does not mean that I feel there is no room for improvement. The Panel only knows what we tell them, when giving comments, if able, send supporting data.
    Thank you and Enjoy the Holidays!

    • jimells says:

      ‘The Panel only knows what we tell them…”

      The panel only knows what the organizers of this circus wants them know. They don’t even get to pick the research to be reviewed! I understand “the panel members had minders who kept the audience and presenters at more than arm’s length from the panel – even during breaks.” (thanks, Denise)

      The idea that a panel of uninformed people can somehow produce an informed report is (insert favorite expletive here)!!

      Where’s the research that shows this convoluted murky process leads to prevention of disease?

  5. cort says:

    I don’t see a direct request for funding or RFA’s – and I need to read the recommendations more closely. I agree that is missing.

    However this report – by a outside group of experts funded by the NIH – provides many statements and opportunities advocates can use to push for more funding and more resources. It essentially states what advocates have stated and everyone in the ME/CFS community knows – the medical establishment and that includes the NIH has neglected this disorder causing huge distress in the patient population.

    The report sites many needs that need to be addressed so that this community can move forward.

    Coming from an NIH group – that’s a huge step forward.

    The reports also makes explicit the need to come up with a suitable definition and identify subgroups. With several definitions purporting to define “ME” and very little research demonstrating differences between “ME”, ME/CFS and CFS, there is no clarity at this time what ME is and how it differs from CFS. That needs to be done and that is some of the important work this report will hopefully help to spur on.

  6. Nancy Henson says:

    It doesn’t take a rocket scientist to understand this disease as to what it does to patients whether they be mildly affected or so ill they rarely get out of bed.

    We need treatment. We don’t need “approved” drugs, we need what works to keep us at a higher level of functionality than we are without it. I have been ill for 30 years. I had insomnia until I learned about ambien. Fortunately, I tolerated it and for the first time I slept more than 2 hrs at a time.

    Then I found a primary care doctor that helped in a few ways that he learned about and then I went to Dr. Lapp who helped me tremendously. No I’m not cured. But I have a life worth living. Now… I am elderly and have all that comes with aging. I’m so glad I don’t have to deal with all the symptoms I had 30 years ago when I first got sick with ME/FM.

    I cannot believe that during these 30 years so called educated people have gone around in circles about this disease simply because they think its merely psychological. Obviously those people never sat down and got to know people who “have” ME and who suffer the effects.

    I am 75 and have given up on all of what is going on. They don’t care about us. I don’t know what its going to take but I no longer care.

  7. Cathy says:

    The report says it’s the Draft Executive Summary. Anyone know if this is the full draft report or is it only an executive summary with the full draft to follow? They’ve already started the clock for comments- I hope they’re not going to sneak another 200+ pages on us the week before comments are due.

    • Jennie Spotila says:

      To my knowledge, the 19 page report is the whole thing.

      • Russell Fleming says:

        For what it is worth, I agree.

        We had AHRQ and a report in full that allowed comments, then an executive summary.

        This was followed by the workshops, and now an executive summary of the whole with 30 days to comment.

        After that I believe this P2P summary will be amended if considered necessary, published, and then a media conference will be held and hopefully media coverage as a result.

        But don’t take my word for it. I was optimistic about this process and still think the end result was worth it – what do I know?

        Deck the halls with boughs of holly. Fa la la la…

        • Jennie Spotila says:

          You got it right. Both the AHRQ report and the P2P report will be published, probably in Annals, and there will be a press effort behind it.

  8. Ren says:

    First, I really believe P2P should use references (internal and a final list) in its reports.

    Otherwise – just some questions (to anyone), please. The following is from ***the opioids-and-chronic-pain draft report*** (not the ME/CFS draft report):

    “Data were presented on three distinct pain mechanisms…: (1) peripheral nociceptive—caused by tissue damage or inflammation, (2) peripheral neuropathic—damage or dysfunction of peripheral nerves, and (3) centralized—characterized by a disturbance in the
    processing of pain by the brain and spinal cord…

    In contrast, those with central pain syndromes—exemplified by fibromyalgia, irritable bowel syndrome, temporal-mandibular joint disease and tension headache—do not respond as well to opioids, but rather to centrally acting neuroactive compounds (e.g., certain antidepressant medications, anticonvulsants).” (p.11) …

    “Peripheral (nociceptive) pain, which typically involves tissue damage or inflammation; peripheral (non nociceptive) pain, which involves damage of peripheral nerves; and centralized pain, which involves spinal or supraspinal mechanisms…

    For example, recent work on the concept of ‘fibromyalgianess’ (the tendency to respond to illness and psychosocial stress with fatigue, widespread pain, general increase in symptoms, and similar factors) identifies at least three components to chronic pain that are important to measure: chronic pain or irritation in specific body regions, somatic symptoms (e.g., fatigue, sleep, mood, memory), and sensitivity to sensory stimuli.” (p. 21-22) [End quotes.]

    Does the concept of fibromyalgianess assume a pathology then, if it’s called a central pain syndrome? And while ME/CFS is not named above, ME/CFS has been called fibromyalgianess by the coiner of that phrase (to my understanding). So does this by extension assume a pathology for ME/CFS? It’s vague, right? The text doesn’t say fibromyalgianess is limited to such and such examples. So, might this info be later applied to ME/CFS? And are there loopholes in the ME/CFS draft report that will allow this to happen?

    Also, the description of central pain syndrome above sounds very different from that used on the American Chronic Pain Association website (affiliated with panel member Penney Cowan): http://theacpa.org/condition/Central-Pain-Syndrome

    A google search yielded some info on classic central pain syndromes, which sound more like the ACPA description. Just very superficially skimming – the end of the article recommends CBT and possibly some (of the newer?) brain stimulation techniques, fyi.

    • Jennie Spotila says:

      I think is a very perceptive point, Ren. When I work on a detailed analysis of the P2P report, I will keep the opioid report in mind. You are absolutely correct that the term fibromyalgianess has been used by Dr. Clauw to apply to ME/CFS, and I was a bit surprised to see him stay away from that at our Workshop. Perhaps he was briefed to do so?

      But this is really important. The signals from a number of speakers was to include ME/CFS in the chronic pain syndromes, and focus on the overlapping conditions aspect. So the opioid report and some of the theories therein would apply to us, in that model. This is one of the reasons why loopholes in the report bother me so much. Perhaps it is more accurate to call it imprecise drafting. By not being as specific as we need this report to be, opportunities are left for NIH and others to pursue this model. And without references in the report, the Panel’s insistence on viewing ME/CFS as a distinct entity could be lost or disregarded. The failure to mention the forthcoming IOM definition also creates such a loophole. In fact, the recommendation of a workshop of experts to come to consensus on a case definition could have been specifically aimed at post-IOM, to reconcile whatever they produce with what we already have.

      I’m repeating myself, but there is definitely strong and helpful language in this report. But if NIH wants to, they could maneuver around some of that language. NIH is certainly under no obligation to follow these recommendations, and the Panel was basically silent on the issue of an RFA. Without increased funding, I don’t care how good the report is, we haven’t moved the ball down the field.

  9. kathy d. says:

    I’m not able to read and digest this right now, but I appreciate your hard work and blogging about the report. And I will get to it when my brain is on alert.

    I thank whoever put in the link to the article in Sunday’s NY Times about Laura
    Hillenbrand. There are many references to ME/CFS and her struggle with it, and
    some of her symptoms, including that disabling vertigo.

    This article should be of help to us. I hope it will be. It should give a bit of
    a shove to various advisors and committees who are on the fence about our illness.

    I didn’t read it in detail, but will do that over the weekend.

  10. N A Wright says:

    Jenny – a forensic deconstruction is valuable, but we do need to recognise that P2P is not a contract . If put to best use, the P2P documents could stand as a Position Statement, imperfect in that no one party gets everything they want, but certainly fit for purpose if applied to making progress across a range of interests. The only alternative would be to seek a winner takes all approach in which patients can only lose. P2P will not deliver ME/CFS into a research land of milk and honey, but as presented the draft document offers probably the best platform there has ever been to lift ME/CFS to a political and scientific equivalent to other equally serious diseases.

    As far as tactical responses to the document, before composing submissions I would urge everyone to read the comments of Prof. J. Edwards – http://forums.phoenixrising.me/index.php?threads/the-p2p-draft-report-is-out.34480/page-8#post-536835 , http://forums.phoenixrising.me/index.php?threads/the-p2p-draft-report-is-out.34480/page-8#post-536858 et seq . It would be a huge shame if patient submissions were overly rooted in concerns with research criteria when science is moving rapidly toward new paradigms of disease description and investigation. There is of course a desperate need for sound clinical description for the purposes of diagnosis of individual patients and the setting of patient needs in terms of continuing health, social and disability support. For both research progress and patient support, it is vital that research needs are not confused with day to day patient needs.

  11. Kathy D. says:

    Agree on the point that without expanded funding for research, this disease of ours won’t move ahead, even if more scientists are agreeing with us and backing up the physiological basis of this illness.
    I mean, gee, ME/CFS gets less than funding for male pattern baldness!
    When it’s taken seriously as the life-altering disease it is, more funds should
    come. I can’t say “will” because there is no basis to say that — but we can
    always hope.
    Funding and government action are way behind the scientific studies to date.
    I feel like we’re trying to climb out of the Middle Ages.
    Funding is critically needed.
    Even Dr. Ian Lipkin, virologist at Columbia, and Stanford U. School of Medicine, as well as other scientists, need government funding. Private donations only go so far.

  12. Russell Fleming says:

    I think ‘private donations’ could go a lot further. One wonders why patients are not as engaging with crowdfunding efforts etc. as perhaps they should be given the claimed demand.

    If the oft-cited 1 million affected in the USA alone is correct, then $10 a year from each patient would fund 10 £1million dollar studies of relative significance. Just the sort of studies that have been lacking in the field for so many years. Not a lot to ask I wouldn’t have thought in the scheme of things.

    Perhaps it is time to put our money where our mouths are. Or perhaps those mouths online are not truly representative of those elsewhere.

    $10 a year doesn’t seem too much to ask from each and every patient – and add to that all those affected from across the world and we have a very nice pot of research dollars.

    But it seems even among those on the internet – research is something seen as necessary and wanted – but not all that important at the end of the day: else surely we’d have seen more success in bigger and better studies by now.

    I am more worried at the evident lack of investment for research. We plead and beg for it but as a ‘community’ don’t seem to value it.

    Is it because we feel it has let us down in the past I wonder or simply that the online demands for more research are not reflective of the majority? Perhaps it is a simple question of priorities.

    Or maybe we are so confused by the endless hypotheses that we don’t really know which horse to back in the race.

    • Jennie Spotila says:

      I think it helps to break the numbers down a bit. First, we assume that there are 1 million patients in the US. I’m not sure that’s true, given that the CCC captures a smaller group in many studies. But accepting the 1 million for the sake of argument, we have to look at how many people have been diagnosed. The data are about 20%, so now we’re down to 200,000 patients. Many of those are not active online or in groups. They are not necessarily aware of who is doing research. It’s very possible that many of those people are just trying to survive. I know one patient who has been correctly diagnosed and she is unable to work. She has to sleep while her kids are in school to be able to take care of them the rest of the day. She is not active online and she has never given to research. Why? Because she hasn’t told most of her extended family or friends about her illness. She’s living under the radar, just trying to take care of her family. The patient population that is actually participating in research and advocacy is a much smaller group than the 200,000 diagnosed.

      I wonder how we compare to other diseases. Does the MS community have the same problem? Yes, I know they have lots more money and have public fundraisers that healthies participate in. But what’s the proportion of the patient community that is giving to research? I bet it’s nowhere near 100%.

      Having done research fundraising for six years back in the day, I can attest to how hard it is to raise that money. But it’s not as simple as everyone giving $10 (although that is a great goal!!). The real money comes from a very small slice at the top. And we have a lot to learn from fundraising professionals and from other patient communities.

      • Russell Fleming says:

        I saw a figure quoted the other day for 18 million with ME/CFS worldwide. It’s the connecting with that I think is the problem.

        Anyway, at present we have a large number of individual charities/non-profits all busy funding what they can in terms of research but all mainly doing small studies.

        Perhaps one way to improve things is to see more joined up thinking. More pooling of resources internationally.

        I am proud of what has been achieved for the Microbe Discovery Project in such a space of time but Lipkin needed $1million for a reason.

        We have to start thinking big and not hoping the NIH/MRC will step in. That leaves us – the patients, our friends and family.

        If we could form consortia among the charity organisations for the purposes of research, assemble scientific advisory boards to assess applications or seek scientists to work on specific areas identified: maybe it would be a step forward.

        All these petty studies over the past 50 years have not really got us as far as they were hoped to. As pilots they were meant to lead to bigger and better based on results – but invariably they haven’t.

        Time to start replicating in earnest and determine if ‘interesting’ pilot results hold water.

        • Jennie Spotila says:

          I totally agree about the weaknesses of smaller studies and multiple organizations going in different directions. While a consortium that pools resources sounds great, speaking as a former board member of an organization, I do not see any short term opportunity for that level of cooperation. But I would very much like to be wrong about that.

  13. NA Wright says:

    @Kathy D. We need to be cautious when comparing research that may seem trivial, to the overall lack of research in ME/CFS. In the case of Male Pattern Baldness there has long been a reputed connection between its occurrence and heart disease; although much of the early research was inconsequential, more recently a strong connection between one form of MPB and circulatory disease has been found. Additionally the biochemistry of MPD has relevance to allergy processes, both circulatory disease and allergy are major health burdens and MPD offers an easily assessable marker for investigation. I’ve no idea whether MPD is negatively or positively associated with ME/CFS in men – but if it were to be shown to be significantly so, then all the MPD work would become relevant to ME/CFS !

    Science rarely advances because of just asking direct questions, often it is the associated results of research that lead to breakthroughs. Funding direct research on ME/CFS patients is necessary, but equally so is the raising of interest in ME/CFS across the whole of medical research. Even with greatly increased spending, if ME/CFS were to remain a specialised ghetto, significant progress would unlikely to be made. Again I would urged people to read Jonathan Edwards’ contribution to the P2P debate – notably this: http://forums.phoenixrising.me/index.php?threads/the-p2p-draft-report-is-out.34480/page-15#post-537603

  14. soph says:

    hey Jennie, as one of few I think I haven’t tried and because you seem smart/cool; would you please read the link to my, what may or may not turn out to be, rambling? (about halfway the comments section)

  15. kathy d. says:

    Whoever wrote to me about my point on lack of research funds and saying ME/CFS gets less funding that money for mail pattern baldness research, I have to say that my father and grandfather had male pattern baldness. My father was balding when I was born; he was 34. Both died of heart disease.
    Therefore, I am not inherently opposed to funding for this particular trait.
    However, what I am saying, and most of the ME/CFS community agrees, this disease does not get the research money or attention it deserves. We have all said it.
    It’s 236th on NIH’s grant list out of 247 ailments, in terms of funds allocated.
    And I do think that all diseases should be researched.
    However, our disease, a very serious one which ruins lives or severely alters them, deserves much attention from the government and a lot of funding.
    When Dr. Ian Lipkin can’t get government funding for research on this illness, there is a huge problem. Nor can a lot of other research scientists.
    This is wrong. That’s it. There is no excuse for it at all!
    According to the documents so far uncovered on the IOM, there has not
    been serious discussion of the science thus far uncovered on this disease.
    And in order to have more research and a larger cohort of patients for
    studies, a lot more government money is needed — not conclusions
    that we need CBT and GET! It is more than insulting to all of us
    whose lives are affected every single day.
    My opinion bottom line is: Cut funding for weapons research, development
    and deployment — and spend it on scientific and medical research and
    treatment for ME/CFS and every other disease that needs it. In other
    words, make human life the priority.

  16. Anne Ö says:

    Thanks, Jennie, for your outstanding analysis and advocacy.

    I see a huge red flag with ‘multimodal’ therapy being so highlighted in the report (mentioned several times) and a ‘multidisciplinary care team (e.g., physicians, nurses, case managers, social workers, psychologists)’ being recommended.

    This is very much in line with the general current thinking on syndromes with ‘diffuse symptoms’ and the recommendations made by the psychiatrists wishing to label many conditions as Bodily Distress Syndrome. It is not a viable way forward for ME/CFS research or care. As other very wise people have commented online, it is a way for doctors to get ME patients off their hands, and once the team is created with nurses, physiotherapists, psychologists, etc, this team is going to want to prove that their therapies are useful in ME. We end up with a new version of the CBT-exercise model.

    Multimodal treatment is also being promoted as a therapy for chronic pain. See for example:
    “Multimodal rehabilitation (MMR) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain.”

    I think we really need to try, through our comments, to get ‘multimodal therapy’ out of the report, as well as the current version of multidisciplinary team. What should be recommended, instead, is biomedical research and biomedical specialist care for ME/CFS patients. There should be multidisciplinary teams, but they should consist of immunologists, rheumatologists, neurologists, experts on ortostatic issues, etc. Centres of Excellence where patients could be referred and biomedical research organized are crucial.

    The multimodal model mentioned in the draft report has been applied to ME in a few places in Scandinavia, among others Stockholm, Sweden. In Stockholm the Health Board decided to see if the health care needs of ME patients could be met by a multimodal therapy model. They initiated a project with a multi-team, involving nurses, physiotherapists, psychologists, social workers. Now, around 5 years later, the project has been evaluated and it has been concluded that this model did not at all meet the needs of the ME patients. The treatment model was very similar to the CBT-exercise model. Many patients actually experienced deteriorated health.

    In Stockholm, there is now agreement between the multi-team project management and other caregivers, patients and politicians that the multimodal model did not serve the ME patients well. Instead, what is needed is biomedical specialist care. While psychologists, social workers, physiotherapists can be useful for ME patients (if they are knowledgeable about the biomedical disease mechanisms in ME, PEM, etc), the money is much better spent on a multi-disciplinary team of physicians, including a neurologist, an immunologist/infectious disease specialist, a rheumatologist, etc. The politicians in Stockholm have announced that a new ME centre will be established, focusing on biomedical specialist care with only one nurse/administrator and all the other resources spent on ME knowledgeable physicians.

    From the report:

    113-116 Existing treatment studies (cognitive behavioral therapy [CBT] and graded exercise therapy [GET]) demonstrate measurable improvement, but this has not translated to improvements in quality of life (QOL). Thus, they are not a primary treatment strategy and should be used as a component of multimodal therapy.

    303-306 We believe ME/CFS is a distinct disease that requires a multidisciplinary care team (e.g., physicians, nurses, case managers, social workers, psychologists) to optimize care. Thus, properly training that workforce is critical

    350 Future treatment studies should evaluate multimodal therapies.

    370-371 We believe there is a specific role for multimodal therapy.

  17. Chris says:

    Anne, many thanks for this very helpful comment. Two details– the ref to your second quote should be 313, not 303, just in case that helps anyone; and could you give us a reference to go to for the Swedish experience, which sounds very relevant indeed-though I guess most of us do not read Swedish! Thanks again.

    • Anne Ö says:

      Chris, how weird, we seem to have different versions of the draft report – in the one I see online the line numbers are different from yours!

      This is what I see on line 303-306:
      We believe ME/CFS is a distinct disease that requires a multidisciplinary care team (e.g., physicians, nurses, case managers, social workers, psychologists) to optimize care. Thus, properly training that workforce is critical

      This is what I see on line 314:
      Clinicians and researchers, who have a responsibility to encourage and track progress


      Are there different versions of the Draft Report?? Is the link I’m using not the correct one?

      • Jennie Spotila says:

        Holy crap, Anne. There might be two different versions. Mine does not match yours. Hang on while I try to sort this out.

      • Jennie Spotila says:

        Ok, there are two versions. The version posted initially was 19 pages long. That’s what I’ve been working from. The version posted now is 25 pages long because they added the panel names, etc. But they also changed the formatting. The original version was 403 lines long. The current version is 389 lines long. I did a line by line comparison, and the only differences appear to be formatting and not content of the report.

        BUT this is a HUGE problem. Some people have already submitted comments, and many people may not have been planning to actually quote from the report but just reference line numbers. Since the two versions have different line numbers, the Panel will face the challenge of guessing which lines a person is really referring to.

        We are reaching out to ODP to alert them to this, and to ask how they will reconcile the comments on these two versions. I’ll post information as soon as we have it.

  18. Chris says:

    @NA WRIGHT; don’t wish to drag this into a personal vendetta, but we seem to be on opposite sides again. Male pattern baldness may indeed be a warning sign for cardio trouble in the future ( will take your word for it), but by the same logic ME is a warning sign for future suicide, early onset heart failure, and cancer, according to one of the few serious epidemiological studies done (Leonard Jason); we also have well documented endothelial damage, dysfunctional blood pressure control, etc. etc., so I think we should take precedence even on that score sheet, ignoring for the moment the huge difference in personal suffering, diminishment of QOL, and ongoing cost to society of the loss of work ability. Male pattern baldness does not cause pain, significant loss of QOL, or loss of work capability and income.

    I did check out Professor Edwards’ comments, and found this: “With cancer we know precisely what we mean by cancer–it is a cellular proliferation that invades other tissues.” Well, scarcely precisely, since the fundamental nature of cancer is under heavy reconsideration–the “Cancer as a Metabolic Disease” theory, begun by Warburg in the 1920s and pursued in lonely near isolation by Pedersen and then Ko and now Seyfried and D’Agostino and others, is now being taken seriously, though it has not yet displaced the current genome theory, despite the recent near collapse of the latter. There is even a near universal cure possibly in sight–3DB–help up by legal battles over patents–a sadly common occurrence in present day medicine. (I am dependent on Christofferson’s Tripping over the Truth for some of this, though did read [more or less] Seyfried’s book.) The process of changing the understanding of a disease goes on all the time–osteoarthritis, not long ago described as a simple “wear and tear” process, is now seen as another inflammatory etc. disease. There is still discussion over whether or not there is a viral etiology for MS. We are not alone in not being fully understood, but I believe we are alone in the grotesque incommensurability between the suffering and loss of all kinds inflicted by this disease, and the amount of research money spent on us by NIH.

    Which brings us to the definition issue, and your optimistic view of the probable results of the P2P draft. On the definition issue we are in partial agreement–it is too early to try for ”definitive” diagnostic criteria, but on the other hand we do need studies that focus as best they can on “the disease we have,” as Jennie put it succinctly, and a definition that explicitly includes those with depression obscures that. In the meantime, the Canadian does seem to be working well enough for the most experienced clinicians and researchers in the field to commit to using it until a better one can be created. They were as you know rebuffed by HHS, and NIH cooked up two projects with the finding of a new definition as one aim; we shall see what the IOM produces. As I wrote in another response, definitions necessarily proceed by trial and error–a definition is proposed, used, the results checked, and maybe a refined version replaces it. But you don’t keep the older version on the books, and you drop many of the false results that came with the replaced version when reconsidering treatment. The Oxford was doing us real damage, and had to go. One major reason was that it was the chief support for CBT and GET as treatments for ME. Incidentally, when we ask for rejection of the Oxford we are being “fetishistic,” but you seem to accept the P2P rejection as OK?

    You write that we need to separate research needs from “day to day patient needs.” Well, yes, but also no–“translational” medicine is showing great promise. You also accuse Jennie of adopting a “winner take all” attitude, and of wishing for a research “land of milk and honey.” I think you are quite wrong on this. I for one would be very happy if NIH just substantially increased our research funding, and stopped sending out grant applications to reviewers with a strong pyschiatric bent (as seems to have been the case with Ian Lipkin’s application, as he comments somewhere.) On the side, I think that to subject a grant application from someone with Ian Lipkin’s record and credentials is insulting–and wasteful of his time–“peer review” is not the pure gold it is cracked up to be. Perhaps they would also reinstate the Centers of Excellence that existed for a few years and were then closed and have been annually requested by the CFS Advisory Committee, and annually rejected.

    But in place of these few and simple responses to our situation, we have a plethora of suggestions, some potentially very useful, but many involving other NIH programs, other committees, more bureaucratic work, maybe another EBM review, etc. Most of us, for very good historical reasons, are wary of this direction. I think the panel’s choice of this strategy is partly or largely due to the unrealistically pessimistic view the panel takes on the current research situation. In fact we now have quite a few groups doing excellent work on/for us, and many collaborations between members of those groups, including members in different countries. I won’t attempt to list them, but just note that Julia Newton has collaborated with Leonard Jason, that Simmaron is working with a group in Australia, and that Gordon Broderick is sharing his special skills with several groups. These people are highly intelligent, very well motivated, and cooperative–I think the less bureaucratic involvement the better–but they all need more money.

    The fact is that the panel was given an impossible task–ME/CFS is without question a very complex condition, with a very complex and unhappy history. It was an impossible task to master all this in a short time, and eyes blinkered by an AHRQ that excluded infinitely more than it included, and with exposure to only a few experts who could cover only a few topics (was there discussion of autoimmunity and the Rituxan trial? Of the autonomic nervous system? Etc etc.?) The research picture is much richer than they knew, though very short of cash– it is not necessary or helpful to try to make a clean beginning.

    I will end with a question to you: having read Anne Ö’s comment on this blog, and having brushed up or recalled your knowledge of just what “multimodal therapy” is (I confess the term was new to me–I thought it was just a general term, and had to go to WikiPedia to discover its descent from CBT and its firm location within psych land), and having noted that the term is used no less than 4 times in the draft (113-116, 314[not the word, but “physicians, nurses, case managers, social workers, psychologists”], 364, 385) are you happy with the prospect of that being the only treatment modality recommended for the short term for our disease–that is, assuming that this is your disease as well as ours?

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