Case Definition Bingo

bingoOur disease is plagued by too many case definitions, with the Institute of Medicine’s Systemic Exertion Intolerance Disease (SEID) being the most recent. Our federal agencies are thus far continuing the agnostic position of accepting whatever case definitions are proposed by researchers or drug sponsors. Communication from the IOM panel members has seemed contradictory at times regarding whether SEID replaces ME, or what to do with patients who do not meet SEID criteria. And advocates are arguing with each other over which definition is “right” and whether to support SEID. This includes some advocates claiming ME is not SEID, and that these two diseases should be kept separate.

This controversy gets to the heart of the IOM report, and the heart of its use and dissemination. It’s not possible to cover all aspects of this controversy in one blog post. Instead, I would like to come at it a different way. Rather than talk about the differences among these criteria, let’s consider the flip side problem of patients who meet more than one case definition. I’ll use myself as an example, and apply the major definitions. Then I’ll talk about a way to think about the muddle we’re in. For a nice overview of the definitions, see chapter 3 of the IOM report. Dr. Cindy Bateman also gave a great talk about SEID that explains some of the IOM Panel’s thinking behind the definition.

Oxford

Ha! Just kidding! You know what I think of the Oxford definition. Let’s move on.

Fukuda CFS

  • Prolonged or chronic fatigue that persists or relapses for ≥ 6 months
  • Four or more of the following concurrently present for ≥ 6 months: impaired memory or concentration; sore throat; tender cervical or axillary lymph nodes; muscle pain; multi-joint pain; new headaches; unrefreshing sleep; post-exertion malaise

When I was diagnosed in 1995, I met these criteria including having all eight of the ancillary symptoms (plus a number of others like dizziness, fevers, etc). Today, I have the fatigue plus impaired concentration, muscle pain, joint pain, unrefreshing sleep and PEM every day. I still occasionally get sore throats, headaches and tender lymph nodes (and dizziness, orthostatic intolerance, etc). So I meet the Fukuda definition.

One thing to keep in mind is that Fukuda draws a really big circle. At the P2P Workshop in December 2014, Dr. Luis Nacul presented data that show 163 different symptom combinations are possible under Fukuda. When PEM is required, that number drops to 35 combinations (still very high). There is no question that there are people who will meet Fukuda but will not meet IOM SEID or the ME definitions. Therefore, I am not arguing that Fukuda CFS is equivalent to CCC or ICC or SEID.

Canadian Consensus Criteria ME/CFS

  • Fatigue
  • Post-exertional malaise and/or fatigue
  • Sleep dysfunction
  • Pain
  • Two or more neurological/cognitive manifestations
  • At least one symptom from two of the following categories: Autonomic; Neuroendocrine; Immune
  • Illness lasting ≥ 6 months

Yes to fatigue, PEM, sleep dysfunction, pain, neurocognitive (such as confusion, concentration/memory, disorientation, info processing, word retrieval, overload phenomena), autonomic (such as POTS, lightheadedness nausea, IBS), neuroendocrine (such as feverishness, temperature intolerance, loss of adaptability), immune (such as sore throat, flu like symptoms, tender lymph nodes), and obviously I meet the 6 month requirement (with an extra 20 years to boot). So I easily meet the Canadian Criteria.

International Consensus Criteria ME

  • Post-exertional neuroimmune exhaustion (PENE)
  • At least one symptom from three of the following four neurological impairment categories: Neurocognitive impairments; Pain; Sleep disturbance; Neurosensory, perceptual and motor disturbances
  • Immune, gastro-intestinal and genitourinary impairments. At least one symptom from three of the following five categories: Flu-like symptoms; Susceptibility to viral infections with prolonged recovery periods; Gastro-intestinal tract; Genitourinary; Sensitivities to food, medications, odors or chemicals
  • At least one symptom from energy production/transportation impairments: Cardiovascular; Respiratory; Loss of thermostatic stability; Intolerance of extremes of
    temperature

I clearly have PENE according to the definition in the ICC paper, at the moderate (mostly housebound) level with occasional severe (bedbound) episodes. For the neurological impairments, I have difficulty processing information and short-term memory loss, headaches and significant widespread pain, unrefreshing sleep and disturbed sleep patterns, and I have the sensory and motor disturbances.

For the immune impairments category, I have flu-like symptoms, nausea/IBS, and sensitivity to medications and odors. In energy production, I have orthostatic intolerance, dizziness, air hunger, recurring feverishness, and temperature intolerance. So I easily meet the ICC definition.

IOM SEID

  • A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities, that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest,
  • Post-exertional malaise, and
  • Unrefreshing sleep
  • At least one of the two following manifestations is also required: Cognitive impairment or Orthostatic intolerance

Importantly, these symptoms must be present at least half the time, and with at least moderate intensity. This is not a bad night’s sleep or minor forgetfulness. Not surprisingly, my doctor confirmed at my last office visit that I clearly meet the IOM SEID criteria, too.

So, Do I Get Bingo?

Where does that leave me? I meet criteria for Fukuda CFS, CCC ME/CFS, ICC ME and IOM SEID. You tell me: do I have one disease or four diseases?

This is the problem confronting all the advocates who are claiming that SEID is not ME. Many patients, like me, will meet the criteria for both. And when this point is raised in discussion, some people have suggested that there are two separate diseases. But if you follow that idea to its logical conclusion, two diseases means two different revenue streams for NIH funding. It also means a drug approved for one disease will need to be approved for the second disease.

If we are talking purely about case definitions, as opposed to real people, then yes ME is absolutely not SEID because the ICC and IOM SEID are different criteria. ICC requires more symptom categories, and specifies the symptom manifestations in each category. And neither ICC ME nor IOM SEID are Fukuda CFS. Dr. Lenny Jason’s most recent paper is just one illustration of that. So if we are purely talking about the definitions – the separate descriptions of requirements for diagnosis – then I think it is logical and clear that ME is not SEID is not CFS.

But that’s not the only context for discussion. Case definitions are hypothetical until they are applied to real people. And when you apply those four definitions to me, I meet them all. This does not mean I have four diseases. It means that these four definitions each describe the disease that I have. Do you see the distinction?

That is the crux of the matter. This thing, this disease that we have, the disease we described to FDA, the disease we can recognize in each other in about five minutes – this thing has been described (with varying degrees of success) by all four criteria. Fukuda CFS is clearly the broadest and least useful definition. Fukuda allows too many combinations of symptoms, and only a fraction of those include PEM. Therefore, it is possible to meet Fukuda and not meet IOM SEID, and what to do with those patients is a quandary for another discussion.

But to claim that IOM SEID is not ICC ME is not CCC ME/CFS is true only in the literal sense that these criteria do not use the same words to describe the disease state that I have, and that many of my readers have. It may be possible to meet one of these descriptions and not another, but that does not automatically mean we all have different diseases, especially when the overlaps among those descriptions seem so large.

I have one disease. That disease has been described in different ways by different groups. The intersection of those descriptions and our experiences as patients must be studied. We need data to understand the characteristics of the patient populations identified by each definition. There will likely be substantial overlap – but is there a biomarker that unites us? Are there subtypes that distinguish us? Is one description demonstrably more sensitive and specific than the others? Did IOM SEID successfully pare down to the most essential elements of the disease, or did they strip out too much?

I have one disease. That disease has been described in different ways. I want my disease to be researched so that the less accurate and less useful descriptions can be retired.

Bingo.

This entry was posted in Advocacy, Commentary and tagged , , , , , , , , , , , , , . Bookmark the permalink.

40 Responses to Case Definition Bingo

  1. Jennie, you have brought great insight to a very complicated subject. You boiled it down to the specifics so beautifully. BINGO! Thanks so much for your time and your EFFORT.

  2. Tina Tidmore says:

    They all are attempts to define or describe the one disease. And that is the way the IoM report reads, describing it as ME/CFS, the disorder, not multiple disorders. There is nothing in the report to indicate the creating of SEID is to add a new subgroup. It does not say how to distinguish SEID from ME and CFS. It says “ME” and “CFS” are inappropriate for “the disorder.”

    All of these are human attempts to define and describe. It’s just some do so better than others. A hammer can also be said to be a tool. But the definition and label of “tool” is not specific enough to identify a hammer. Yet, of you mean “tool,” and don’t mean just a hammer, then you should use the word “tool” because it has a broader definition.

    I like the way you say we really know this disease and can spot it in someone else. We know what parts are variable in each of us and what is at the core, the commonality. We also know that many of us have gone from mild to severe back up to moderate and a few of us went back to mild. Does that mean we moved from CFS to ME to SEID to CFS again?

  3. Thanks for stating this so clearly Jennie. This is what I’ve failed to explain to some who have claimed that only a small group have ME, but that I and the rest of us have something, else maybe because I didn’t have the classic sudden onset on the disease, who knows. But I am like you, I meet all the definitions and I feel that I have one disease that millions of others also have, and each of us would like NIH to provide significantly greater research funding for this ONE disease to identify etiology, create approved treatments and prevention so that we can all be well enough to work, live and play like healthy people.

  4. Nita Thatcher says:

    Bingo! Once again, you are spot on, rational, logical, and reasonable! Thank you!

  5. Robert Morley says:

    This is an excellent analysis. I think in the long run, we’re going to find that we are indeed grouping a few different things under whichever moniker we use, but it’s very important to recognize the major vs. minor distinctions. Jennie and I sound very much alike, though unlike many patients I’ve spoken to, there are no clear flu-like symptoms for me—at least not how I understand the term—nor did I start with any kind of flu-like illness. (Though there was a flu a couple of years before onset of symptoms that left me drained like no other flu ever had, and included myalgia, so perhaps my symptom onset was just substantially delayed compared to most.) Long story short, this is a minor difference, and we’re otherwise virtually identical in terms of symptoms.

    I have another friend who has a somewhat different set of symptoms, but who still overlaps mine a fair bit. She gets a different variant of PENE in that she can sit for ten minutes or so and recover some amount of energy, though full recovery still takes her hours. I can’t do that…it always takes a long time for me to recover if I’m starting to feel tired. That, combined with the other differences in symptoms in several categories, is a major distinction not entirely covered by current criteria and it makes me question whether or not she and I have the same thing.

    Finally, another somewhat infamous online personality who falls under at least the Oxford and Fukuda definitions has said in various conversations that muscle and joint pain were never a part of his experience in any way. He believes that ME/CFS is just a variant of burnout and that anyone who has it can recover, as he did, by following his example. Clearly, however, he does not have the same thing that many of the rest of us are describing, despite his beliefs to the contrary.

    So, to summarize, I don’t believe that the different criteria each describe a different disease. I’m not yet convinced, however, that even those of us who have PENE necessarily all suffer from the same thing. PENE is a major distinguisher, however, and I think in the fullness of time, we will discover that there are a couple of major diseases being covered by the ME/CFS/SEID titles and that there are either several variations of them or at least that there is a wide difference in symptoms between some patients. In the end, however, we need to decide what define the major distinctions and then do our research from there. Grouping totally unrelated things together isn’t useful, but neither is splitting hairs between ME/SEID at this point in time. When we have a better understanding of the disease(s), that will be the time to re-examine the differences and see if there’s something more to be learned from them.

    • Jennie Spotila says:

      I think we have to keep several ideas in our head simultaneously. First, the point of this post is that the different case definitions can all apply to one disease in one person. Second, it is possible that we have all reached this disease state by different paths or inciting incidents. Third, my disease might be different from your disease, and the case definitions are too coarse a tool to detect that at this point.

      I think my first statement is clear (one disease, one person, multiple definitions). But the other two statements are hypotheses, and we need data to sort that out.

      • Robert Morley says:

        Agreed on all counts. In the end, we just don’t know enough yet to be sure of anything about the disease(s), but one thing I do know: as long as we continue to use overly broad definitions or multiple definitions, research will be of limited usefulness. Let’s “pick a lane”, as it were.

  6. Lisa Petrison says:

    One would hope that everyone with more severe and specific illness who meets narrower definitions like ICC also would meet all broader definitions. Otherwise, there’s something wrong with the at least one of the definitions.

    That is one problem that I have with the proposed IOM definition. I know many, many people who currently meet the criteria for all the other definitions including ICC and who have all the classic biomarkers who do not currently meet IOM, because of the unrefreshing sleep requirement that none of the other definitions have. (And in at least one very high-profile and well-documented case that I know, the person reported never having had unrefreshing sleep.)

    When people get to a good environment, the unrefreshing sleep often resolves on the first night, even though usually none of the other symptoms gets any better right away at all. Mold avoiders who are taking extreme measures to improve their health and who are still heart-wrenchingly sick should not be excluded from any definition of this illness just because of their avoidance activities. Neither should people with this illness who inadvertently get to a good environment. So I would say that purely based on this, the IOM definition needs to be revised if it is going to be used.

    A different concern is that I also know many, many people who met the criteria for some of the other definitions at the beginning of their illness, but who didn’t meet ICC or CCC until much later on. I would posit that those people had the same basic illness all along – it just got worse over time.

    I also know many mold avoiders who used to be at a severe level of ICC but now meet only Fukuda or even who now meet only Oxford. I think those people have had the same illness all along too – it just got better.

    Certainly not everyone who has only substantial prolonged fatigue (or fatigue plus certain other symptoms) has “mini-ME” or “pre-ME,” but it seems unarguable that some of them indeed do.

    If we were all in agreement that there is nothing that can be done about the illness, then not letting people be diagnosed with anything specific until they are indisputably unusually sick would be okay. But if one believes (as I do) that early intervention is key, then there is an enormous problem associated with only choosing a definition that is too narrow.

    From what I have seen, people who are diagnosed when they are not that sick yet have much more potential of regaining at least some of their health than people who already are severely sick. There are things that do seem to help them (such as rest and pacing, avoiding toxicity such as bad buildings and problem locations, promoting detoxification, and dealing with progressive infections such as borrelia), from what I have seen. On the other hand, wait until people are really sick and it is very, very, very hard to come back – as I have found out myself.

    So from that perspective, I do not object to something broader as a clinical definition. Catching people early on may be critical in helping them.

    What I do object to is using that kind of broader definition for research purposes.

    The idea that the way to find core abnormalities is to study the clear cases is wholly uncontroversial among epidemiologists. People who are only mildly ill (such as those who may qualify for the IOM definition) are not clear cases and thus are not the right people to be studying, if the goal is to find out what is going on.

    I also object to the idea of making it seem to clinicians that the broader definition (e.g. the IOM’s five symptoms) is all there is to this illness. For people who are more severely ill (ICC and especially ICC severe or very severe), that does them a tremendous disservice from a clinical point of view.

    I am willing to accept that there is not enough solid literature for the IOM committee to have put in place a subgroup based on lab testing.

    But there is no reason that we should not have a subgroup (or multiple subgroups) based on severity in place now, so that more the clear cases can be specifically researched and also so that those who are severely ill will be more likely to get appropriate clinical care.

    Why the IOM committee didn’t do that, I don’t understand. But just because they were negligent in not doing it doesn’t mean that we can’t make it happen anyway.

    • Jennie Spotila says:

      Thank you for this comment, Lisa. There’s a lot to unpack here.

      I want to start with a question about something you said in the first line: “narrower definitions like ICC.” What does this mean, and is it accurate? What I mean is, what does it mean to say ICC is narrower – that it will diagnose fewer people? That is true in relation to something like Oxford or Fukuda, no doubt. But it seems less true relative to other criteria. This figure from Lenny Jason’s recent paper shows that 62% of the SolveCFS Biobank patient sample met his four symptom criteria (fatigue, PEM, neurocognitive, unrefreshing sleep) and 58% met ICC. That’s not a huge difference. We also don’t know if all the ICC patients met the four symptom criteria – it’s implied by the figure but it’s possible that some met one but not the other. And having more required symptoms (thus presumably being narrower because fewer patients will meet the requirements) is not necessarily desirable, as Jason’s work has shown requiring more symptoms can sweep in more psychiatric comorbidity.

      “I know many, many people who currently meet the criteria for all the other definitions including ICC and who have all the classic biomarkers who do not currently meet IOM, because of the unrefreshing sleep requirement that none of the other definitions have.” I’m planning to cover unrefreshing sleep in an upcoming post because it seems to be such a sticking point for many people. I do want to point out, though, that Lenny Jason’s four symptom criteria – which was empirically derived – includes unrefreshing sleep as a requirement.

      You point out that people who get to a good environment and no longer have unrefreshing sleep should not be excluded from diagnosis. I agree, and I don’t think they would be if criteria are properly applied. We could make the same point about people who do not experience PEM because they pace themselves sufficiently. Just because a symptom is being managed by treatment (whether it is a good environment or pacing or something else) does not mean the disease is no longer present. Withdraw the treatment and the symptom returns – because the disease is present! An analogy might be someone whose cancer is undetectable while on chemo, but withdraw the chemo and the cancer comes back. They had cancer all along, it was just the treatment that made it undetectable. Another example is HIV. Someone who has no detectable virus and normal CD4 count while on triple therapy still has HIV. It’s just not detectable because of treatment.

      You make an excellent point about people who may not meet ICC early on, but who get there as their condition worsens over time. Conversely, there are people who improve on treatment and may no longer meet ICC but still meet Fukuda or Oxford. Intuitively, this sounds right to me and the SEID criteria do not explicitly address this point. It’s important because SEID captures severity by requiring symptoms to be at least moderately severe and present at least half the time (as Lenny Jason’s criteria do). IOM didn’t comment on people who may improve to no longer meet those thresholds. However, I’m not aware of any published data addressing this issue, either. We don’t have longitudinal and natural history studies, and we desperately need them. That might quantify the patient experiences we’re talking about here and help address this problem.

      “What I do object to is using that kind of broader definition for research purposes.” Yes, I agree! We’ve been plagued by this. I don’t think it’s enough to say patient were selected using X case definition, even CCC or ICC. How was diagnosis confirmed? Were any other requirements applied (such as exclusionary criteria, etc)? There is not enough rigor in our field on this point. The PACE trial claimed to have analyzed data applying Fukuda, but we know they only required the ancillary symptoms to be present for 1 week instead of the 6 months required by Fukuda. Why were they allowed to claim they applied Fukuda? A researcher said to me recently: case definition is just the starting point. Research has to do more than that, better than that.

      Finally, to your point on the severely ill, I agree that the IOM did not address the most severely ill patients like Dr. Ron Davis’s son. On the other hand, I’m not aware of any studies that really investigate this subgroup. What does “severely ill” mean – in a quantifiable way, not the way we think about it in our experiences. We’ve succeeded in convincing some researchers that the severely ill need to be studied, but I’ve heard that some studies are having trouble recruiting severely ill subjects.

      IOM’s requirement to derive criteria from the evidence base is a double edged sword. On the one hand, it’s great to have a report so thoroughly referenced and therefore harder to dismiss. On the other hand, our evidence base is grossly inadequate because poor funding means no natural history or longitudinal studies, smaller studies, and studies with easier to access patient cohorts. The evidence base is overwhelmingly white; the CDC multisite study has a 95% health insurance rate. We know that this is not an accurate reflection of the patient population because community based samples show higher prevalence in minority and lower socioeconomic samples.

      We need research. A lot of it. We need to test these criteria against each other. We need to study the most severely ill. We need to recruit a large sample and study them over time. We need to catch people early on and try to intervene. The list goes on almost to infinity. And for all that, we need resources.

      • Lisa Petrison says:

        It is not just my guess that the ICC is a substantially narrower definition than any of the others currently being discussed (Fukuda, CCC, IOM). It also came directly from someone who I consider to be an expert on the topic of definitions of this illness. I will see if this person will be willing to state publicly what was stated to me privately.

        The idea that the inclusion of more psychiatric comorbidity suggests that a definition is in any way flawed seems to me to be a fundamental scientific error.

        Current mainstream scientific thought suggests that psychiatric symptoms such as depression can be a result of brain inflammation, and a whole string of papers by Dr. Michael Maes and colleagues suggest that certain kinds of depression are associated with the exact same cytokine abnormalities that “ME/CFS” is.

        Following is an article with references to that line of work, in which I point out that these are the exact same abnormalities that have been found to be associated with trichothecene exposures:

        http://paradigmchange.me/wp/depression/

        The most universally agreed-upon clearest cases of this illness were from the Tahoe epidemic, of course. And the mood swings exhibited during the epidemic were as dramatic as the memory losses and other physiological manifestations there – as would be expected since those people were really, really sick in a neurological way.

        Insofar as psychiatric symptoms are a physiological manifestation of the underlying core disease processes, then we might expect that those who actually have this core disease and who are severely ill with it will be more likely to display psychiatric symptoms than are those who have something that is similar but different or than those who have a milder version of the same thing.

        If that is the case, then it may well be that a definition that is better at picking out more specific and more severe illness indeed _should_ be associated with more psychiatric comorbidity. And therefore, that rather than increased comorbidity being a sign that a definition is problematic, it should be seen as a sign that the definition actually is working well.

        Which, perhaps, is what we are seeing in the findings you reference, with regard to the ICC/CCC.

        On a broader note:

        The most important problem that I see at this point is that unless it is made abundantly clear that this IOM definition is inappropriate for research purposes, and unless an alternate definition is put into place for research purposes, then if the IOM definition is adopted at all we can assume that it will be used for research. Just as, of course, people have used the Fukuda definition (officially a clinical definition) for research.

        It’s all well and good for certain advocates and certain experts to agree among themselves that research needs to be done on more specific populations. I’m glad to see that.

        But so far, I have seen no movement in this community that seems likely to lead the government to make it clear that IOM definition should not be used for research purposes.

        And that being the case, the adoption of IOM for any purposes is something that I find objectionable.

        Insofar as a separate definition for research purposes were put into place, I think the IOM definition has some potential. Just for clinical purposes, I think it has some positive characteristics as well as some unresolved issues that conceivably could be worked out.

        For instance, accompanying materials would at a minimum need to make it clear that a) the disease can include a wide variety of symptoms other than the ones mentioned in the definition (with those symptoms specifically listed); b) the disease can include severe pain (meaning that prescription of pain medications may be appropriate); and c) severe patients present specific clinical challenges (with detailed instructions on how those patients should be addressed).

        And as you say, the idea of not ruling out people because their symptoms are being effectively treated in whatever ways should be stated specifically too.

        Thus far, none of these things has been addressed at all. But they could be.

        So in my mind, there is still a huge amount of work to be done on both the clinical and research fronts, before we can go forward with implementing the IOM definition for any purpose.

        What continues to be most shocking to me about the IOM report is that – despite the presence of people like Ron Davis and Nancy Klimas on the committee – there was not even a mention of the fact that severely ill patients even exist, much less a suggestion that these people may need special clinical care or particular research study.

        Everyone may agree when push comes to shove that severe patients deserve attention. But why, then, are so few people in positions of influence in this community talking about this issue proactively?

        I have my own ideas in terms of what could be done to serve the needs of severe patients, but they are just my ideas.

        The only thing that I for absolute sure know needs to happen is for more people in this community to start talking proactively about the needs of severe patients as critical, with the goal of creating consensus to develop a real strategy to study them as well as to help them clinically.

        It would be great if Solve ME/CFS Initiative were to talk about the importance of the needs of severe patients in its upcoming media event, for example.

        • Jennie Spotila says:

          I absolutely agree that psychiatric comorbidity could be really important on the neuroinflammation issue! This is why I am not as troubled as others by the lack of exclusionary conditions. As long as people who ONLY have a psychological disorder are successfully excluded, I am not concerned about people who have this disease also having a psych disorder as long as this is accounted for in research.

          I agree that the needs of severely ill patients must be discussed and addressed. Mary Dimmock asked a question about this at the SMCI briefing today, but I missed Dr. Clayton’s answer.

          • Anonymous says:

            1) In the beginning of Chapter 4 in the IOM report, there is acknowledgement of the limitations of the knowledge base to date and it is specifically mentioned that there is very little published data on the severely ill. If “severe” means “homebound or bedridden”, there is in fact only one published peer-reviewed paper that specifically address this group. (Wiborg, 2010) The point of such acknowledgement in the report (and in the discussion sections of most scientific papers on any topic) is to tell readers about the limitations so they can judge for themselves how far to apply the findings. The same issue can be applied for ethnic minorities as most ME/CFS studies are over 95% self-identified Caucasian.

            However, just because a study doesn’t cover the exact group doesn’t mean the findings don’t apply to them. They still might; it does means that more research has to be done so we can be more exacting. In most of medicine, clinicians have to treat or manage patients that don’t necessarily have studies that correspond directly to them. For example, if you have an 80 year old female Native American colon cancer patient with high blood pressure/ epilepsy/ and diabetes, the number of studies addressing this specific patient with her individual problems are not large or may not even exist so you have to go by studies out there that are based on say, younger Caucasian males without other diseases and patch together pieces from other studies you know of.

            More research funding can always help but there are areas of medicine where it is extremely difficult to get the exact answer you need because of logistical/ ethical/ other concerns.

            2) If someone improves spontaneously or with treatment, unless they improve to the point of being cured, they are still considered to have the specific chronic illness. People are confused about it with ME/CFS but there are many other conditions in medicine where people improve/ change and no longer formally qualify for a diagnosis in regards to certain symptoms/ physical findings/ or labs but are still considered as having the diagnosis based on their initial findings and that fact they still feel sick or need maintenance treatments whether pharmaceutical or not (e.g. a carefully monitored diet/ exercise regimen that successfully controls blood sugar in diabetes does not mean that person does not have diabetes).

    • May12th says:

      Lisa, why would someone with mould exposure be covered under any of these definitions. I would see that as an exclusion. Mould exposure falls into the Environmental Sensitivity definition. You avoid it and rid your system of the toxins and you feel better.

      • Lisa Petrison says:

        Just during the past several months, many of our community’s most prominent advocates have publicly acknowledged a mold connection to their own illness, and many of our most prominent researchers have expressed interest in studying the topic.

        Following is a link to a transcript of a discussion between Pandora president Lori Kroger and Dr. Nancy Klimas on this topic, for instance.

        https://www.facebook.com/lisa.petrison/posts/10203428383302621:0

        In my opinion, the proper way to state a hypothesis on this topic is as follows: “Exposures to the environmental agent of certain mold toxins may constitute a risk factor for acquiring ‘ME/CFS’ or for having an existing condition get worse, and this needs to be studied.”

        With people like Mady Hornig, Nancy Klimas, Kenny de Meirleir, Paul Cheney, Derek Enlander and Lenny Jason now all talking about toxic mold exposures as a possibly relevant factor in this illness, rather than as any kind of exclusion, my mention here of whether various definitions meet the needs of mold avoiders seems to be a reasonable topic of discussion as well.

        Best, Lisa

        • Heather says:

          I hate wading into this in a half thought out way, but here goes. Vaguely incoherent thoughts to follow.

          My young adult daughter is a moderately severe patient of Dr Bateman’s who was diagnosed by the ICC and CCC. She meets the criteria for ALL the definitions. Like many adolescents, she seems to have had a viral trigger. That being said, when Dr B discussed how my daughter ended up with this illness, she told us she believes it is a threefold process: 1)genetics (anything from weak IG production, methylation issues , allergies,etc) 2)environment. This can be physical environment–mold, toxins, chemical exposure, as well as physical (intense exercise for elite athletes for example) and emotional stressors, trauma–anything that can trigger epigenetic expression or simply cause imbalance in body systems (like heightened adrenals) 3)trigger–when some process (like a virus, or could be immunizations or surgery)overwhelms the body and, when taken with #1 and #2, the body collapses and goes into an acute, then chronic disease process.

          What this tells me is that like cancer–another broad word that describes a host of processes–ME/CFS/SEID–will likely look and feel different for many individuals. Back to cancer: Some cancers are environment, some genetic, some bad luck, some a combination. Some make tumors, others infest blood or tissue. And yet leukemia, lymphoma, melanoma and brain cancer are all cancer.

          I’m going to go out on a limb and say this Disease may be similar. Some people may get ME because of mold exposure, some may get it from EBV, some may get it from food poisoning, some may get it after dental surgery. Why can’t this disease be seen, for now, by whatever criteria work (CCC, ICC, IOM) to get forward momentum and we leave the sub-groups and perhaps totally different, distinct diagnoses to when more data is available? I suspect bioinformatics, genetic research and the ongoing research with the Lights and Ian Lipkin will ALL illuminate and provide more insights. I feel like there is such Balkanization and tribalism showing up in this community and I don’t feel like, in reality, that beyond some really horrible Oxford definition/GET types, anyone is trying to exclude or isolate anyone. There are a lot of desperate sick people who need help.

          I don’t know what definition to use. In a pragmatic, real life way, the whole “diagnosis criteria name game bingo” is irrelevant in my daily life because it doesn’t change how sick my child is, nor does it provide meaningful solutions to her illness. What I do know is that I can take a big fat IOM report to my daughter’s primary care doc and tell him that treating her POTS is helping and that those sleep meds make a difference. There is now context for her symptoms that is available in a digestible, mainstream, respected form. IOM is not fringe medicine. It is harder for mainstream medicine to blow them off and that HELPS my child. It helps bring her from the margins and validates her.

          If the IOM clinical definition helps make it easier for me to get my daughter the care she needs and starts to force insurance and other official bodies to acknowledge it, I’ll take it. I don’t think it has to be all or nothing. I don’t feel like I’m betraying anyone or settling for anything or being deceived by some vast conspiracy for believing that some good can come from the IOM, at least at the very basic patient care level.

          For research purposes, let them duke it out. As long as they toss Oxford (and hopefully Fukuda), what is left will have legitimate justifications behind it. The better research seems to be using ICC/CCC type criteria to choose subjects. Whether that continues to be the research gold standard will be determined by people who know a lot more than I do.

          • Lisa Petrison says:

            What you say about the etiology being related to a variety of different factors (as is thought to be the case with cancer) rather than a single factor certainly could be what is happening in this disease, Heather.

            However, personally, I’m more moving toward the idea of considering whether this may be a “multiple strikes” etiology, rather than an “either/or” one.

            For many people, it seems that exposures to certain kinds of toxic molds act as a weakening factor, making it more likely that those individuals will succumb to pathogens (such as those associated with viral infections or food poisoning or surgery) and be unable to recover from them.

            Many people who fell ill suddenly (following a documented infection or a trauma or a vaccine) subsequently have found out that they were living or working in a very bad environment at the time (and then reported that they improved substantially later on by avoiding mold), for instance.

            There’s an enormous amount of literature that shows that trichothecene mold toxins in foods have devastating effects on the immune system, and an increasing amount of evidence that inhaled exposures to such toxins also can be responsible for severe immune effects.

            So if I were going to take a guess at this point, it would be more that at least in some people, extended exposures to certain mold toxins make it more likely that the immune system will be affected in a way that makes it easier for the array of pathogens that we see in this disease to become chronic.

            The question that we don’t know yet is how big of a risk factor mold exposures are – whether they are playing a significant role just for some patients who end up with the underlying disease that these definitions are trying to get at, whether they’re playing a role for many of those patients – or even whether they are a factor for all of these patients. At this point, we just don’t have the scientific evidence to say one way or the other.

            So my hope is that now that acknowledged experts in this disease have become interested in this topic, it will be possible to figure out just how big of a role exposures to this environmental agent are playing – and thus whether prevention and treatment strategies focused on mold might be worthwhile.

  7. Mary Dimmock says:

    Thanks for the post, Jennie.

    I think that there are two separate but related issues here

    First, you make a good point that a case definition is not the same thing as a disease. A disease has its own biological reality separate from our attempts to describe it with case definitions. And while there may be a need for a tighter research case definition and simpler diagnostic criteria for clinical practice, those should be describing the same disease/clinical entity.

    But currently, there is a lack of clarity and mixed messages on whether the SEID criteria are intended to describe the same disease as CCC/ME-ICC, whether SEID is intended as a new name for ME, and even whether the name SEID is intended to replace the name ME/CFS if the CCC criteria are used, as they are likely to be in research. That kind of semantic confusion is part of why we are where we are today and needs to be resolved.

    But the second point is that your meeting Fukuda, SEID, CCC, ME-ICC and presumably Oxford does not show that all five definitions all accurately represent the same disease, as you know.

    Given the experts letter and its use in research and the clinics of experts, its fair to say that disease experts believe that the CCC is a good representation of this disease. We know that Oxford and Fukuda are not good because they fail to require hallmark criteria and allow patients with deconditioning, depression and other causes of fatigue to be misdiagnosed.

    But what about SEID? Does it accurately represent this disease? It recognizes PEM but not some key neurological symptoms or some of the symptoms of the newly ill or the most severely ill that CCC and ME-ICC cover. It drops exclusion criteria while relying on subjective methods to assess symptoms. The assessment tools are not adequately operationalized.

    The question is whether doctors can reliably use the SEID criteria and the recommended symptom assessment tools as defined today to accurately diagnose patients at e.g. different levels of severity or time since onset while weeding out unrelated conditions that look similar. If SEID is intended to describe the same disease as CCC, I’d think these issues need to be addressed through addressing the obvious gaps and validating criteria before they get used. Otherwise, we risk creating another wastebin of overdiagnosis while failing to accurately diagnosing those with the disease.

    • Jennie Spotila says:

      Yes, I agree that the messaging has been mixed! And this is a great concern. Also a concern is the silence from HHS.

      A balance has to be struck. On the one hand, we don’t want criteria rolled out that are not specific and sensitive enough. We don’t want inadequate roll out to result in just another wastebasket because doctors are not given enough information to apply criteria correctly. And like the other case definitions, just because there is consensus on a committee about criteria does not guarantee that the criteria will be any good (Oxford, anyone?).

      On the other hand, there is what Robert succinctly described as “pick a lane.” We know this disease is under diagnosed. We know that doctors do not presently have accurate information and tools to correctly diagnose people with the disease (and exclude people who do not have it). And we’ve waited 30 years for criteria that accurately capture the disease and also have the support of the government. CCC is never going to have federal support, and will never be rolled out to doctors in this country. If HHS was willing to do that, they would have done it at some point in the last 12 years.

      If SEID is going to be thoroughly tested, correctly rolled out, and accurately applied, we need a huge concerted effort on change management. I find myself wondering if anyone has the leadership, resources and foresight to actually take that on. And I fear the consequences if no one does and we get a half-assed roll out with insufficient education for doctors.

      • May12th says:

        Do doctors not have the tools or is it they haven’t been taught in med school or they don’t wish to use them? I’m a patient and I can understand the CCC overview and the primer so I would expect an MD could as well.
        My sense is more they don’t want to get involved with a complex illness with no proven treatments. We also know from studies that doctors have to be taught in med school and its the new doctors that educate the older doctors.

        • Jennie Spotila says:

          I think most doctors do not have the tools, in terms of specialist knowledge about this disease. They’ve never read the CCC or the primer. They don’t know what tests to run except to exclude other things. And as recent comments on many of the IOM news coverage has shown, there is active hostility and prejudice against the disease and the people who have it.

    • Anonymous says:

      I’ll say this as a clinician and researcher trying to understand ME-ICC and CCC. On first glance they seem OK but when you actually try to use them, they turn out to be very complicated and face some of the same issues that Fukuda has. Try memorizing ME-ICC or CCC — there’s plenty of at least one or two symptoms out of 3-4-5 categories depending on the category — that is way too complicated. I tried putting together a computer algorithm to work it out and just doing that was complex.

      Also, if people are worried about polythetic criteria in Fukuda, get ready for even more with ME-ICC and CCC. For some categories, multiple symptoms — on the order of 10 or more different ones — are listed; the problem is they are taken to be equivalent when they may not be. E.g. problems with thinking are not the same as vision problems to a clinician yet they’re both placed under “neurological/ cognitive issues.” Luis Nacul calculated 165 different combinations of symptoms that Fukuda could generate; ME-ICC and CCC would generate even more.

      • Jennie Spotila says:

        Actually, someone more math/computer savvy than me should do this. How man combinations are there for ICC and for CCC?

      • Tina Tidmore says:

        I had begun to realize the numerous optional symptoms in CCC could present a similar problem as Fukuda. But you made it more clear.

  8. Fab4Eyes says:

    Thanks for spelling it out this way! What a quandary. I meet most of the criteria for each of the “four” diseases, but then there are symptoms/diagnoses I have that are not listed. So I haven’t been given the ME/CFS/SEID diagnosis officially because my doctors keep saying, “but that doesn’t explain these other things.” Sigh…

    • Jennie Spotila says:

      Actually, I’m not convinced that this is the right approach. SEID is no longer a diagnosis of exclusion. According to IOM, if you meet SEID criteria, you have the disease no matter what else is going on. It’s also important to remember that other diagnoses are not expected to explain everything a patient experiences – for example, a person diagnosed with cancer may have symptoms not explained by the cancer, but they still have cancer.

      On the other hand, it might depend on what “these other things” are. There’s a difference between unexplained symptoms and symptoms that confound the diagnosis. I hope you get answer soon!

  9. Jenny says:

    “I have one disease. That disease has been described in different ways.” is a great way to describe the problem succinctly. I think for me this is an even wider issue as I meet these case definitions but also have Fibromyalgia and Pots diagnoses. I’m not at all convinced that these are different things in my case (I know people do have Fibromyalgia or PoTS without any other diagnosis) but I think that CFS, SEID, ME, PVFS , POTS, and Fibromyalgia are all attempts to describe what is wrong with me which will probably at some point be given one specific, subgroup label.

  10. Gabby says:

    I am not sure if I catch the logic.
    If one fulfills the CC and ICC criteria, which demand more symptoms, chances are that they would also fulfill SEID, Fukuda and Oxford.

    But, does that mean those that fulfill SEID, Fukuda and Oxford criteria also fulfill CCC and ICC? I don’t believe so.

    What if I would come up with a hypothetical “Gabby’s criteria” for the disease that only required two symptoms – Fatigue and PEM. You would fulfill the criteria for Gabby’s criteria as well. Does that mean that Gabby’s criteria describes the same disease as CCC and ICC?

    Just because the criteria of two diseases are similar does not mean that they are describing the same disease.

    Oxford for example, although it has some similar criteria as CCC and ICC, most probably does not describe a disease at all. It is, most probably, just a group of symptoms.

    For example, I have a friend who has been feeling burned out. She is not sleeping well. Because she is not sleeping well, she is cognitively slow. She says that she can hardly get out of bed in the morning, she is so tired. She states that when she does too much, all she can do is crawl back into bed. When I showed her the IOM criteria, she said, that’s me! Except that it is not her. If asked about the CCC criteria, she doesn’t fit at all.

    In their effort to fulfill their charge from HHS to create simple criteria for GPs to be able to use for diagnostic purposes, I am afraid that they have created a set of criteria that will be over-diagnosed in a major way.

    • Anonymous says:

      Gabby – I am very sorry that your friend is having difficulties.

      You give no indication of how long she has been having problems or whether or not she has been seen by a healthcare professional.
      That your friend does not want to get out of bed sounds much more like depression or burnout than SEID or ME.

      There is also no indication in what you say that your friend experiences PEM.
      Healthy people (as well as people with other illnesses ) have days when they feel cognitively slower than others but that is quite different than problems with working memory, psychomotor problems, and other cognitive impairments that the work of Dr. Lange demonstrates.

      In addition a diagnosis is not made solely based on a list of criteria but rather also on descriptions of what those criteria actually encompass. This does however highlight the need for standardization of terms.

      No matter what your friend has, I hope she gets the help she needs.

      • Tina Tidmore says:

        Also, SEID criteria requires symptoms 50% of the time (all of them) and reduction in activity/function and for six months.

      • Heidi says:

        My first symptom of CFS in 1993 was “not being able to get out of bed.” I used to call in to work and say that I “could not get out of bed” as it was truthful, and I supposed they thought I was an alcoholic or similar, but I could think of no other way to say it. This was the first aspect of CFS that interfered with my life (I imagine I already had low blood pressure, etc. but no one chose to see me as ill.)
        How this worked: I would sleep for a long time, a very hard low-temperature near-comatose type sleep, and I would wake up in a way which moving my arms and legs were a distinct and difficult effort. The bar that I set for myself was that I would call in sick if I could accept that I would be fired if I could not get out of bed. So you see that most days when I thought about being fired, I would manage to get out of bed. Some days, however, it was not possible to get out of bed whether I would be fired or not, and on those days I called in sick (and saying that “I could not get out of bed” because there was nothing else obviously wrong.)
        This is the “paralytic muscle weakness and pain” that Maryann Spurgin wrote about in ME.
        I had also fatigue (vs. total collapse) all the time, I had Fukuda type symptoms, I probably had immune markers at that time. I did not know about PEM or how to analyze my experience to decide if I had it. My personal opinion in 1993 was that I had lymphoma (based on reading the Merck Manual), but the doctor I went to thought I had nothing.
        I was, of course, dopey during collapse states, but, for about 4-5 years, if I was not in collapse I had no cognitive issues. I was weak and felt fatigue, but I could read, write, think, etc. while sitting or lying quietly. This, of course, changed, and I now have neuropsychological testing evidence of brain damage, but that took years.
        I now meet all those ME/CFS definitions, etc.
        But my point is: my very first interfering symptom in a 20-year downward ME/CFS spiral was that I “could not get out of bed.” And no, I was not depressed or burnt out.

    • Jennie Spotila says:

      I agree that not everyone who meets Fukuda or Oxford will meet SEID or CCC or ICC. I think the meaningful comparisons, and what really needs to be researched, are the people who meet SEID and/or CCC and/or ICC. Maybe that is virtually the same group of people, maybe it is not. This needs to be tested.

      Regarding your friend, I think it’s important to point out that the issue is not meeting list of symptoms. Another commenter pointed out the requirements of severity and length of illness, which your friend may or may not meet. But the real key here is the role of the physician as diagnostician. A doctor has to elicit more than just the checklist. A good doctor would discuss with your friend the full circumstances, and might decide that she is burnt out rather than sick. Or perhaps she is sick, despite being burnt out. But this has to be determined by looking at the full picture over time, not just a checklist on one occasion. This is why the provider education important is so critical, and why we must get it right.

  11. Simone says:

    Thank you for yet another excellent analysis, Jennie. Too many use the different criteria to argue that the ME and CFS are different, without recognising that the criteria are simply the result of an imperfect iterative process to describe a disease. Like others, I suspect that there are several sub-types which account for much heterogeneity within the population. I think often the call to separate ME from CFS comes from a desire to not be associated with the negative stereotypes that have been lumped on the CFS label. This is unfortunate, as we’re then doing to others within this population of sick people what we all have experienced from the general community (& medical profession)… invalidating.
    Hopefully, as the years progress, more objective measures will be used for diagnosis (we have the 2-day CPET, but it is not widely used, and has its downsides for those undergoing it), and hopefully then we can focus on what type of ME/CFS the individual has, coming through a better understanding of the disease process, rather than politics.

  12. Deborah Waroff says:

    An important discussion, Jennie, and thank you for your dedication. A few notes:

    1. I was diagnosed from the Holmes definition in 1989. Let’s not forget that the Fukuda definition of CFS was ordered up (by CDC or NIH? I’m not clear) to replace the Holmes definition. Why? One aspect, according to documents which an American male patient obtained via FOIA, was that NIH official (the late) Dr. Steven Straus (in correspondence with Dr. Fukuda) sought to expand the openess of interpretation to psychological causes. Dr. Straus even pronounced on the 1996 Sam Donaldson show that “CFS” was definitely a psychological disease.
    In short, US government officials tailored FUKUDA to increase psychological attribution for Tahoe disease. Key government officials wished to increase psychological attribution. Above all, NAIAD director Anthony Fauci, close friend to the late Straus, for nearly 30 years now has insisted upon policy aimed at perpetuating psychological attribution.

    Bless the IOM committee for its important and brave stand against this corrupt policy.

    2. The rejection of encephalitis or encephalomyelitis by the IOM report as a symptom that is insufficiently documented appears to be a consequence of NIH influence on the bibliography and other sourcing. As outsiders to date have not been able to obtain copies of the final contract it is impossible to be sure.

    However, the experience of data selection in P2P and such information on future inputs as was available before the final contracting between NIH and IOM do suggest that NIH had some (if not total) control over IOM bibliography and other research sourcing and that they used this control to eliminate myalgia and encephalomyelitis from contention as Big Deals. Certainly it is astounding that recent evidence from Stanford and Montoya were not included. Would Microsoft launch a product based on 2009 technology?

    Equally, the excuse printed for eliminating study of pre-Holmes work (that it would be de facto included in later work) does not ring true. It was eliminated because it pointed too much in directions NIH did not wish to see pointed to. (Note that fraudulent UK PACE trial “data” was included in the bibliography with no caution as to its dubious and manipulated nature.)

    Thus, aspects of neurology, brain and spinal cord involvement seem to have been in short supply for IOM in coming to the SEID parameters. Nonetheless the IOM report cites downstream consequences such as cognitive dysfunction that would seem to result from brain activity, which tends to leave the most informed readers puzzled.

    My chief concern is that insurers and medical authorities will see cause to deny treatment for myalgia and/or encephalomyelitis due to its de-emphasis by IOM.

    3. PEM is a good “flag” symptom for doctors to notice possible directions for further enquiry. It is cheap. It is easy to detect provided a doctor speaks with a patient. However, the IOM committee could hardly be expected to come up with a complete further approach to diagnosis based on five meetings and a truncated set of research sources. Further work needs to be done.

    4. We need to keep in mind that it was the Tahoe outbreak for which the CFS name and description was first assigned. The Tahoe outbreak was described at the time by experts as equal to M.E., which they had experience of. The CFS designation was substituted for several reasons, but CFS = Tahoe = ME.

    • Anonymous says:

      In terms of insurers, it is ultimately up to them to consider what to cover or not. Insurers that are privately owned — many of them — are not mandated to follow ANY government guideline. They only do so inasmuch as following guidelines will give them cover from getting sued in court for not following certain standards of practice.

      The IOM document does mention myalgia as a supportive symptom so although I would never underestimate the loopholes insurance companies can find, it does make it difficult to deny when it’s in the report and even a whole subsection devoted to it.

      And “encephalomyelitis” is a pathophysiological process that can results in lots of different symptoms (including problems with sleep, cognitive issues, etc.) so what are you referring to when you say that IOM report would make it easy to deny treatment? And what treatment would that be?

  13. Kathy D. says:

    Thank you, Jennie, for your hard work and analysis of the various definitions of our disease that you present here excellently.

    I am tired and can’t follow all of this discussion, nor can I figure out which definition my disease fits and which it doesn’t, although it seems like it fits all of them.

    From reading your list of symptoms, I know that I have most of them, with post-exertional collapse (I refuse to say malaise; it isn’t), muscle pain, often
    debilitating, exhaustion and cognitive abnormalities. In fact, in the last
    few months, I have worried about dementia because I’ve forgotten such
    basic things, including regular appointments, and more. If I have too
    much on my mind or haven’t slept well, that worsens all of it.

    But in the unrefreshing sleep category, I would add “NO SLEEP.” I have
    nights when the morning hours roll around and I have not slept at all.
    This is a disabling problem, as we know the disease symptoms get
    worse without refreshing sleep or any sleep.

    Anyway, I think you for your work. I, too, am troubled by the lack
    of response to the IOM report by HHS. I am also concerned as is
    everyone else about the lack of attention to Stanford’s study
    of brain abnormalities so well explained by David Tuller in the
    New York Times — and with photos of differences in the brains
    of people with and without this disease, whatever it’s called.

    I appreciate everyone’s comments and will come back here when
    I’m not so tired and can make sense of them.

    I think we need to figure out what to do about all of this. That’s
    essential to moving ahead.

  14. Jane says:

    Thank you for another thoughtful post. I think you illustrate the multiple aspects of the current case definition confusion concerning “the disease” well).

    This is more of an “offshoot” side point about the efficacy of case definitions.

    Like you said, those of us who have it can recognize it in 5-10 minutes. But those who don’t (including the majority of the mainstream medical community) have little to go by under the new SEID criteria than so-called “subjective,” self-reported symptoms, much like Fukuda (a point that disability providers love to make). Unlike the ME-ICC for example, the criteria doesn’t reference various objective tests that can be done to confirm the physiological abnormalities that manifest in the symptoms.

    I understand that the IOM had to work with what we have now. The current state of science is that there are is no widely accepted take-a-blood-test (or an MRI) kind of objective biomarker. So they ended up with a conservative criteria that could not assume any objectively testable abnormalities because there was not sufficient evidence of a single test or set of tests that they could confidently include within the criteria.

    BUT as long as we don’t have a case definition that at least acknowledges objective test results and biomarkers (and hopefully incorporates them as soon as they are discovered and widely recognized), we will have this problem of describing the disease in the subjective words of patients, a problem that is at the root of doctors treating it as a “wastebasket” disease. And so we are caught up in things moving painfully slowly on all fronts:

    Subjective case definition –> little research funding and research advances;

    Little research funding and research advances –> not enough evidence for objective marker-defined case definition.

    It would be nice to see the funding and the advances so the status quo can change.

    • Anonymous says:

      Objective tests ARE in the document as well as in the Clinician’s Guide published by the IOM references: 2-day CPET, natural killer cell activity, formal neuropsychological testing, and tilt table. They are suggested as ways to confirm a diagnosis or to establish disability. I would advise people to persue the report and other materials before making conclusions.

      http://www.iom.edu/~/media/Files/Report%20Files/2015/MECFS/MECFScliniciansguide.pdf [see pages 11-12]

      The tests are supportive, not required, because as you allude to, there is not enough data yet to say that 100% or even 95% or 85% of patients are confirmed to have these abnormalities. If they were made required and it turned out later on that only say 70% of people had them, then 30% of people might have been excluded erroneously. In addition, some tests need people expert enough to administer them: for example, if the tilt table test is done for only a few minutes — which is fine for people with ONLY OI — it will not pick up patients with ME/CFS AND OI. So the tests have to be done correctly or the results will turn out to be false-negatives (e.g. the patients really has an abnormality but it is not picked up on testing). Finally, for some people, the tests may have severe negative PEM consequences; they are not risk-free. And then’s there’s cost of testing.

      I would also contend with your assertion that CCC or ME-ICC require testing. Re-read those criteria. While the text of the original CCC and ME-ICC papers mention tests that can be done, neither case definition requires or even mentions any tests in particular.

      http://sacfs.asn.au/download/me_international_consensus_primer_for_medical_practitioners.pdf [pages 7-8 are the actual criteria]

      http://phoenixrising.me/wp-content/uploads/Canadian-definition.pdf [see pages 11-13]

      • Tina Tidmore says:

        Dr. Clayton said consideration for the severely ill is one reason they did not make the 2-day CPET required. It would be cruel, she said. And it can be discerned from the patient history.

        Excellent point about others not requiring test for diagnosis.

  15. Jim Ellsworth says:

    Here is a link to the Straus letter mentioned by Deborah Waroff:

    http://www.cfidsreport.com/News/14_Chronic_Fatigue_Syndrome_Definition_IOM_Straus.html

    There is much other interesting history on Mr Maupin’s website including interviews with former NIH officials.

    The Straus letter makes it clear that “Fukuda” is actually an “anti-definition” intended to define the illness out of existence. I see no reason to think that goal has changed.

    I keep getting this image of Fauci and friends having a good laugh at all the advocates running around in circles fussing over case definitions while NIH continues to do nothing to help us. Doctors obviously pay little attention to the current case definitions, and they will continue to misapply all of them for another generation, unless a high-profit FDA-approved drug comes along.

    I’m still trying to understand the political history of this illness and who is pulling the strings. In the UK we have actual evidence of close ties between the psychobabblers (Sir Simon Wessely and friends), the disability insurers (UNUM), and their propaganda arm known as the “Science Media Centre” (co-founded by Sir Simon). Nine years ago a UK Parliamentary Group found conflict of interest and called for an investigation, which never happened:

    “numerous cases where advisors to the DWP [Dept for Work and Pensions] have also had consultancy roles in medical insurance companies. Particularly the Company UNUMProvident. Given the vested interest private medical insurance companies have in ensuring CFS/ME remain classified as a psychosocial illness there is blatant conflict of interest here.”
    https://en.wikipedia.org/wiki/Controversies_related_to_chronic_fatigue_syndrome

    Was Straus and Fukuda connected to the insurers? How about Fauci? It is very interesting that he was so closely connected to Straus. HHS/NIH/CDC has made deliberate policy decisions to not research this illness. We need to know who is making these decisions, and on whose behalf.

    Until those “deciders” (as the horrible George Bush put it) feel our wrath, the policies will not change, there will be no significant public funding for research, and we will remain dependent on meager private funding for research.

  16. Julia says:

    Hi Jennie, your last sentence in bold, that is it for me as well. I appreciate you spelling this out so clearly.

Comments are closed.