Lenny Jason has taken the IOM Report ” “Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness” to task in two published articles.
In his first article, Jason decried the restrictions the IOM process put on collaboration. He argued that the process of creating a new name for chronic fatigue syndrome should have involved all the stakeholders in the disease.
In the most recent article “The IOM’s Effort to Dislodge Chronic Fatigue Syndrome” Jason questioned the makeup of two of the secondary criteria and argued that the committee should have used statistical analyses to assess the criteria before publishing them. He also asserted that people with primary affective disorders – people whose primary illness is a mood disorder and who also meet the criteria for ME/CFS – should have been excluded.
Jason is our resident expert on defining ME/CFS. Unfortunately, in this case, he was on the outside looking in
Jason has argued for years that a poor definition has thwarted us from making progress in virtually every important area. Defining ME/CFS correctly, he’s asserted, is one area we must devote more resources to. He is, in fact, our only expert on defining ME/CFS and naming it, and has published in both areas – the first extensively. He seemed like a natural fit for the committee. I asked him why he was not on it?
He gave a brief answer to what he said was a complicated question– that he had signed the petition opposing the IOM process, and given that, he felt that he could not be on the committee.
He also noted that if he’d been contacted he might have been able to resolve some important issues.
“First, the task of writing a formula to test the new case definition took about one hour, and a large data set was analyzed in about 2 more hours by a member of our team. Had the IOM asked me to compare their criteria with others, we could have done this easily, and provided them the outcomes. Could it have informed their work; my guess is that it would have.
Jason’s analysis of the proposed criteria – after the report was published – appears to have uncovered some flaws
However, until the report was released, we had no idea what new criteria were being proposed. I had minimum contact with the committee members as they were not to speak to anyone about their work. I think that this works fine for most IOM products, but in our community, this was probably not the best way to build a consensus for a new name and case definition.” Lenny Jason – pers. communication
Contact with people outside the committee is clearly not permitted by the IOM. The consensus they form comes from within the committee.
“the committee works independently to come to consensus on the questions raised. In fact, while the committees may gather information from many sources in public meetings, they carry out their deliberations in private in order to avoid any external influence” IOM
Going Rogue?
Jason has twice asserted, however, that in this instance, the IOM committee should have gone “rogue” and disregarded their mandate and reached out to the public and researchers.
“However, the patient and scientific community could have been actively involved in selecting the case definition and its criteria prior to the dissemination effort. This involvement would represent a departure from the process that has historically existed.” Lenny Jason
The consequences of stepping outside a longstanding process are unclear but doing it would have been risky. Would it have been worth it to take the risk?
Going “rogue” would have affected the legitimacy or even possibly the publication of the report
My guess is no. The IOM process does not by design embrace outside collaboration. It is purposefully limited to the participation of selected experts. If that sounds elitist, it’s also its strength. The IOM process puts a premium on producing rigorous and objective analyses by gathering experts, and then by creating a sealed environment that limits the impact of outside influences. That process is a key reason the IOM – in existence since 1970 – is so well regarded.
Contravening that process might have, in this instance, resulted in a better report. It also, however, could have resulted in the report being terminated and would have blunted its legitimacy and impact as well.
Missing Influence
If Lenny Jason had been a part of the committee, his voice would have been heard. He would have been able to test different iterations of the criteria, and I think he would have been able to resolve the issues that troubled him.
I don’t think outreach was needed to create the best criteria for ME/CFS. I think Lenny Jason was needed, but unfortunately he removed himself from participating in the process. That process appears to be over.
What To Do Now?
Now that we have criteria our sole expert in the field disagrees with what do we do now? I imagine Lenny Jason’s upcoming studies will indicate the criteria has some flaws. What to do about that?
I don’t know if the diagnostic criteria changes are possible at this point. The IOM is probably not, after a year or so working on this document, willing or perhaps even able to revisit the criteria. A finished report has been presented to the public. Can changes be made? I don’t know.
If the criteria are set, the big question is whether these criteria are an improvement or a step backwards? In my mind, there’s no question that, whatever their flaws, they’re a considerable step forward from the Fukuda criteria and the Canadian Consensus Criteria. We may not have gotten the best criteria, but expecting that, given we didn’t have our top guy in there, was probably in retrospect, unrealistic. Instead, we got much-improved criteria.
The Insider?
I think Jason was obligated, once he saw issues in the IOM report, to bring them up, and his insights will surely be helpful. Next time, though, hopefully, he’ll situate himself inside the process. That’s where the ME/CFS community needs him. Among other things, a community with few resources and many needs simply needs to be as efficient as possible.
Now we have something of a mess: we have our only expert disagreeing with key facets of a federally produced report that was supposed to point the way towards a new approach to this disorder. This, we didn’t need.
A Bigger, Better Process – Next Time
If we had the means to start over should we? Should we try to get the federal government to do that? Would that be a good use of our resources?
My guess is no. I trust Lenny Jason. My guess is that he’s probably right, but I also believe that the criteria are probably also good enough. We had very smart people working on them.
With this field still in flux the criteria were expected to be temporary placeholders until the appropriate studies were done. They can stand.
If changes to the criteria can’t be easily made, the best next step might be to move on.
Meanwhile, our resources remain very limited. The IOM and P2P reports are the first significant projects the federal government has taken on since the State of the Knowledge Workshop in 2012. Before that we have to go back to the Neuroimmune Conference of 2003, I think it was, and the following RFA, to find anything significant.
Let’s not let the perfect be the enemy of the good. This process was never going to be ideal. The federal government is not at the point where it funds “ideal” in ME/CFS. Comprehensive examinations of any subject are going to be rare.
For now, though, let’s spend our very limited political capital where it can do the most good: on increasing research funding, getting Centers of Excellence and finding a home in an Institute. The next time the name and definition come up for change hopefully we’ll have the clout to give the process the attention it deserves.
Fantastic and well-reasoned assessment, once again, Cort. I think you hit the right tone. Thank you.
As a reminder, I believe Dr. Montoya had stated that he applied the new IOM diagnostic criteria to his patient group with 100% match. Can you confirm?
Thanks….
Hadn’t heard that about Montoya. I expect, though, if the criteria aren’t perfect and I assume that we’ll find out that they’re not with Lenny Jason’s studies – that they’re close…
We’ll see!
I agree, Cort.
The community of people affected by this disorder did have a chance and many did voice their opinions at the outset. Once the committee convened, I do believe it was important to the credibility of the report to NOT have ongoing input/influence on the part of the patient community. In this case, with this disease, it could have undermined the credibility of the IOM findings. I say that not because of the excellent advocacy that our community has engaged in, but rather because of the nature of the marginalization of the disease, which historically, and currently, has been facilitated by depreciating the subjective experience of those with it.
That’s a good point – one that I didn’t bring up in the blog. This disease, of all diseases, needs to do this process and others by the book – sometimes to our loss. Any straying will give our doubters room room to delegitimize any findings.
That’s just where we are at this point, I think.
For people with ME/CFS to believe that a disease that receives $5.6 million dollars a year in money from the NIH to think that they’re ever going to build “Center’s of Excellence” amazes me! They didn’t even do that with $3 Billion dollars a year that Congress allots to AIDS research.We need to find a home at the NIH and respect in the research community, the name makes no difference. This morning I had a weekly summary from Medscape with 5 Articles about Chronic Fatigue just last week. Unfortunately, almost all of the doctors comments were derogatory about us just being a bunch of slackers collecting disability because we don’t want to work! Until we find a non-research test to diagnose our disease we still don’t exist in the minds of modern day MD’s? They just don’t accept that belittling us and denying our symptoms is contrary to their oath of “doing no harm”. Very sad statement on today’s Medical Care.
I agree Gregory – home in an Institute is critical! We have a long way to go with the medical profession. We are the MS of our age – or one of the MS’s of our age…
A big problem is that the qualities that make for a good clinical definition may be very different than the ones that make for a good research definition. Possibly that is true for diseases in general, and it certainly is true for this disease at this moment in time.
It’s important, in my mind, that a clinical definition not to be too narrow or and that it not point only to people who are very sick. Many severely ill ME patients started out at a milder level of illness and then declined over time, for instance.
People at early milder stages of the illness need to be diagnosed since early interventions (such as rest, toxin avoidance, promoting detoxification or treating infections such as borrelia) may be helpful in preventing people from becoming severely and permanently sick. The disease is much more difficult to treat effectively once people are very sick, and so identifying people early on is crucial.
It would, in my opinion, be wrong to deny people of a clinical diagnosis based on psychiatric history. Psychiatric diagnoses are rampant these days, and in many cases psychological symptoms seem to be a core physiological component of overall disease of “ME/CFS.” The work of Michael Maes and colleagues suggest that depression and “ME/CFS” are related to the same cytokine abnormalities, for instance. Insofar as depression or other psychiatric abnormalities are a core physiological manifestation of the underlying disease processes, then excluding people who get psychiatric symptoms first makes as little sense as excluding people who get, say, digestive symptoms first. It’s just out-and-out discriminatory, based purely on politics rather than anything related to science.
I agree that even for clinical care, the proposed definition has some flaws. Several people who have classic ME (by all the other criteria) have said that unrefreshing sleep is not a problem for hem, for instance. Pain seems an important enough symptom that may have been a mistake to leave it out of the criteria (especially since the lack of mention may make it more difficult for patients to get pain medication).
In addition, insofar as clinicians believe that the five symptoms are all that there is to the disease, it likely will reinforce their belief that the disease is something trivial. Certainly the IOM materials do not go nearly far enough in informing clinicians about how severely and broadly the disease may manifest, and this needs to be remedied.
But these are relatively small problems compared to the issue of using the criteria for research purposes.
People who meet the proposed criteria may be only very mildly sick, and there is a risk that some people who meet them actually will have something else entirely (especially if PEM is not rigorously screened).
Using these criteria rather than more rigorous criteria (such as the CCC or ICC) is a good way to make sure that we will never find anything of note in terms of abnormalities. And it also will mean that misleading research leading to mistaken beliefs about the illness – such as that of the Wessely School – will not be put to a stop.
A good research definition likely would be similar to the ICC or CCC, in that it would require a larger number of symptoms and a higher level of severity, in order to make sure that those who are participating actually are substantially sick with this particular disease.
Conceivably psychiatric exclusions might be acceptable in a research definition, though if a wider number of other symptoms were required, that might not be necessary either. Since possibly people with psychiatric issues might be different than those without psychiatric issues (e.g. might be more sick or more likely to have severe cognitive problems), it would be better from the point of view of rigor not to exclude them from a research definition either unless it absolutely seemed necessary.
The IOM definition was developed as a clinical one. However, the Fukuda definition was supposed to be a clinical definition too, but it very often has been used for research purposes. Unless it is made clear that the IOM definition is inappropriate for research, we can assume that it will be used for research purposes too, if the government adopts it.
I agree that re-doing the IOM criteria for clinical purposes likely would have some difficulties associated with it. But the idea of creating a new research definition to sit alongside the IOM definition certainly should be considered, regardless of what happens with the clinical definition.
It was negligent of the IOM panel not to bring up the problems that would be associated with using this clinical definition for research purposes, just as it was negligent for the panel not to bring up the particular issues that severe patients face and to encourage more research into their issues.
The fact that the panel did not recommend a subgroup for severely ill patients actually is a disgrace.
But just because the panel was negligent with regard to some critical issues doesn’t mean that everyone else should follow their lead in terms of being negligent about those issues. We do not have enough time for that.
http://www.paradigmchange.me/wp/iom/
Lisa, I couldn’t agree more. Thank you.
Cort, another excellent article, as always. My question is regarding Dr. Leonard Jason asserting “that people with primary affective disorders – people whose primary illness is a mood disorder and who also meet the criteria for ME/CFS – should have been excluded.”
If a CFS/ME/SEID diagnosis requires post exertional malaise (PEM), then wouldn’t the PEM requirement eliminate those who have fatigue only as a result of depression or some other mood disorder? I just haven’t heard that depression causes PEM. (Of course, I have only been studying CFS/ME for two years, so I realize I don’t know everything. )
Cort, can I please ask your thoughts on that? Is it your understanding that Jason wants to exclude those with primary mood disorders from being diagnosed with SEID, or that he wants to exclude them from research studies to avoid compromising study results?
I believe a subset of people with major depression do experience PEM – I’m not sure how large the subset is. It is something I think read somewhere, though. That’s as accurate as I can get.
My guess is that in this country this is not a big deal for research studies because my guess is that most patients in those studies come from ME/CFS practitioners who are able to determine who had primary depression first and with secondary ME/CFS – and they wouldn’t put them in research studies. Even if that’s true this issue should be resolved however. I have a feeling we’re going to get a study from Lenny that makes that very clear 🙂
Thanks Cort.That is interesting. I hadn’t heard of PEM with depression before, unless the person also had CFS…. I hope they don’t exclude pepple suffering from a primary mood disorder from being DIAGNOSED with CFS/ME/SEID. Maybe exclude them (or include with caution as mentioned before), from STUDIES, but not a CFS/ME/SEID diagnosis. People can have both depression & SEID, just like they can have both asthma & diabetes, or depression and cardiovascular disease, or many other combinations. Thanks for responding.
Hi Cort, What a well balanced response. I am impressed and agree with your conclusions precisely. I think the biggest problem is the inclusion of primary mood disorders in the IOM criteria. I agree they should be excluded, inclusion allows results from new studies using the IOM criteria to be diluted and possibly less conclusive, but the same could be said about other co-morbid conditions. This problem can be remedied by researchers excluding primary mood disorders in their studies.
Best,
Pam Miller
People with major depression do NOT experience PEM. Au contraire. People with major depression actually improve with physical exertion.
I know people who are members of the IOM. Of course the IOM can deal with outside people. They can call anyone they please to testify. I mean outside of public sessions as well as in. And they can contract analyses like Lenny’s just as they contracted out editorial assistance.
We know the NIH strong-armed them to accept two behaviouralists. I believe it had a major role in determining the reading list. The question is how much was the committee constrained over all.
I wonder if that’s true. Editorial assistance to make a paper read well is a different thing. Lenny Jason thought it would be departure from historical procedures to do that, and I can’t imagine that the committee wouldn’t have welcome Lenny Jason’s assistance if they could have had. Why wouldn’t they? He’s our expert. He’s worked with many of them for years. I think they would have loved to have him participate and they would have if they thought they could have.
This is what the IOM website says.
“In fact, while the committees may gather information from many sources in public meetings, they carry out their deliberations in private in order to avoid any external influence”
Look at this list of ME/CFS experts on the IOM committee:
Lucinda Bateman
Lily Chu
Ronald Davis
Betsy Keller
Nancy Klimas
A. Martin Lerner
Benjamin Natelson
Peter Rowe
Does it really make sense that two behavorists are going to be able to cow Nancy Klimas, Lily Chu (who has ME/CFS), Lucinda Bateman (whose sister had ME/CFS and whose experience – being told by doctors she was depressed – resulted in Dr. Bateman becoming an ME/CFS practitioner), Ron Davis (who’s son is severely ill) and the rest – into omitting biological studies from their purview?
These are not shrinking violets. They knew a lot was at stake and I think they would left if they didn’t feel they were given the opportunity to do their job.
I would also note that Jason is almost certainly the most cited author within the text of the IOM report* — so much so that at times I wondered if they used any other sources. 😉
I would like to see Ms Waroff’s evidence that the behavioralists dominated this report (who besides Alegria is she counting as a behavioralist?). Indeed what I think is staggering is that the psychogenic proponents who have major career stakes in this disease (aka Peter White or his American comrades such as Christine Heim or Edward Shorter) were NOT on this panel nor in the P2P workshop (Buchwald & acolyte notwithstanding), which is HUGE. The 2(?) behavioralists had no career connections,** while the 8 (yes, the majority of the committee) biomedical proponents had significant career and even more significant personal stakes in this report. If anything, the IOM so clearly stacked the panel in OUR favor.
_________________
*Which would make sense given that I imagine he’s also probably published more on this disease than anyone else. His team is a publishing machine.
**Alegria’s one paper is insignificant; if she’s counting Mulrow, her career is not connected to this disease because she once 13 years earlier did an independent literature review in which she simply acknowledged what the literature showed with the dictated perimeters. The reason for that is not Mulrow’s fault. Moreover CBT and GET did not escape criticism in that review.
I did not say that Alegria or any other dominated the report, which would be quite contrary to my impression of it. I said that NIH pushed IOM to take them.
Dr. Mulrow’s role I believe was more to serve as an expert in the ways of conducting a systemic review. I believe she is an expert in that. I’ve forgotten her medical specialty.
The committee definitely showed little admiration for CBT and GET and did not recommend them.
The interest re Alegria is simply the fact that NIH pushed her and apparently another behavioralist in the committee; why? I would have liked to see a neurologist in the space, perhaps an MS specialist. By comparison, the shame of taking Alegria is that it would seem she was dead weight. None of her work would seem to fit with the product; she had written that our disease is neurasthenia and psychogenic, and the report never gets within spitting distance of that.
Natelson, a neurologist, was on the committee. There has developed a trend in all medical government committees to include psychology or psychiatry. Of course, we are more sensitive about it than others. The idea is that medicine is about the health of the whole person, not just the body.
Anything done in a clinical setting, diagnosis and how that diagnosis is reached, will have a psychological impact.
We must also consider that they have felt credibility required a token psychiatrist. If I remember, doesn’t she specialize in underserved communities?
Edward Shorter is not a clinician – he is a historian of psychiatry.
http://historypsychiatry.com/2012/04/26/how-i-became-a-historian-of-psychiatry-edward-shorter/
@Deborah Waroff: So can people with Major Depressive Disorder never get “physical” diseases like, say, Congestive Heart Disease or cancer? Do people with mental illness get some sort of magic shield from all organic diseases? If no, then why can’t they get an organic “physical” disease like ME/SEID? Is ME/SEID some sort of unique disease that is neither organic nor mental? Or is it more like a Bil Reeves “mind-body” illness that is both at the same time?
That’s the crux of the issue here. The point of the IOM report is for clinical NOT research purposes. And that is where I — for the first time ever — disagree with Dr. Jason. His criticism is valid if these were for research purposes. And I do think it’s absolutely correct to be concerned both about them slipping into research use (as Fukuda slipped into clinical use when it was initially intended only for research purposes) and that clinicians do not have the skill to recognize PEM.
But we do not want a situation where someone who has PEM but also happens to have bipolar disease, depression, or obesity not receiving a correct diagnosis and ultimately incorrect treatment such as GET when it will make them sicker.
The IOM report has removed our disease from the “fatigue” category and moved us to the (so-far) unique category of PEM. Let’s not move ourselves back to “fatigue.”
Well said, Michelle.
Actually, in theory, people with Major Depressive Disorder should get non-psychiatric diseases at an above average rate. Major depression is bad for the immune system and also tends to result in poor self care.
I don’t know if they get congestive heart failure and cancer at above average rates. PWME get congestive heart failure and cancer at way above average rates.
Of course people have co-morbidities. You just don’t want them in your research cohort, like you don’t want people over certain ages in your research cohort because they present their own common co-morbidities to confuse your data. And you want to make sure each ME case is a bona fide ME case, not major depressive disorder with bells on.
We agree. For research the cohort should be pure are subgrouped according to comorbidities, which requires a larger cohort than most of the studies in this disease. The purpose of a criteria for research, at this stage of science in our disease is to isolate abnormalities that cause symptoms of this disease. If you have patients with other diseases with other or even same symptom, you won’t know if what you find is for this disease or the others.
But a clinical criteria must reflect the realities the clinicians see.
Well, um, THIS is depressing. lolol Ahem. Sorry. I frequently laugh at the most terrible things. I have no idea what else there is to do. Other than stealing my life, CFIDS/ME/SEID/Are You SURE You Are Not Just Depressed?-Disease…( AYSYANJDD) is apparently no big deal to those who do not suffer it. Isn’t progress primarily about money or lack thereof?
I think that the report provides us with two very important weapons:
The first recommendation was that SEID receive an ICD classification not connected to either CFS or neuresthenia. This seems to me a very clear refusal of any psychiatric category, although we do need to be very careful about the (I believe, phony) category of ‘somatoform disorders’.
The second is in their explanation that the name ‘Systematic Exertion Intolerance Disease’ was intended to reflect the severity of the illness, and the fact that it was a ‘disease’, not a ‘disorder’ in which exertion, and type, and presumably any amount (some people have, mistakenly, I believe, interpreted this to mean much exertion) ‘may adversely affect many organ systems’.
The psychiatric model is based on the idea that after a viral illness, patients become anxious about normal, minor symptoms, form the ‘false beliefs’ that a) they have a physiological illness, and b) that exercise will harm them.
The IOM report, as above, insists that this illness is a disease, and that exertion ‘may adversely affect organ systems’. So actually, we do have a physioloogical illness, and exertion does do us physical harm.
The treatment of CBT in Wesselian terms, is to talk us out of our ‘false beliefs’, and GET is to reinforce denial that physical exertion will harm us.
Since SEID says our beliefs are true, and exertion will harm us, it seems to me that if this is accepted, it destroys the entire psychiatric empire. My own view is that we need to hammer this home, at every point and again and again.
On the issue of differential diagnosis between depression and ME/CFS/SEID, this is vital, because exercise does lift the mood of a person who is depressed, and is harmful to a person with ME. And, on the basis of thirty years as a psychotherapist and 25 years as a PWME, I assert that anyone, in a ten-minute conversation, can make the differential diagnosis. If the person you are talking to ‘doesn’t feel like doing anything’ because they are too sad, or too apathetic…spot the mood disorder. If they report feeling a bit better after exercise, second tick to the box..depression. If, on the other hand, the person you are talking to is desperate to do things, tries, and finds that almost immediately their muscles fail them, and they can’t continue…and they (justifiably) get very upset about it…you are not talking to someone with a mood disorder, you are extremely likely to be talking to someone with ME. Despite all the medical palaver, it is not rocket science. And the difference is of major importance…the depressed person will really benefit from being dragged out for a walk, a swim or a bike ride. The person with ME will really benefit from being told to get back on the settee and concentrate on serious resting.
“The first recommendation was that SEID receive an ICD classification not connected to either CFS or neuresthenia.”
The IOM report recommended:
‘A new code should be assigned to this disorder in the International
Classification of Diseases, Tenth Edition (ICD-10), that is not linked
to “chronic fatigue” or “neurasthenia.”’
What an excellent and common sense analysis of the situation. You have just reinforced my reasons for coming to your site for the best and most reliable information.I do so appreciate a clear sense of perspective when people are writing about ME and Fibromyalgia issues.
I am frankly very frustrated that so many individuals and groups (Not Jason–I think his are needed here, for some perspective) are publishing scathing blogs and posts on this subject and dividing and subdividing us poor people who just want some decent diagnosis and treatment and research.
You are absolutely right. If we are going to quibble about everything and continually tear various efforts apart because we don’t see it the way others do, nothing will improve. I believe that various factions are alienating people like me. I know there are some FB groups I no longer post in, because they are so opposed to this and some other organisations. I am sure there are critical issues and problems, but we can’t keep shooting at those who are on our side, claiming that they too, are the enemy.
I have not been around in the ME community for years and years. I am one who has a Fibromyalgia diagnosis (since 13 yrs ago) and as yet no ME diagnosis because I have not encountered a doctor who believes either illness is a biomedical one. I feel that if some have their way, people like me will be tossed aside so they can whittle the sufferers down to a group with only a certain very narrow set of symptoms and degree of illness and onset. The rest of us are not in their picture. I may fit their definition, but then again, I don’t even have a diagnosis.
There are so many like me. I see so many people posting in Fibromyalgia forums whose stated symptoms would fit the CCC and ICC criteria, but they have been told they have Fibromyalgia. Who can say what we have until and unless there are doctors available to us who know how to diagnose properly? And I wonder… is it even clear that Fibromyalgia and ME are two distinctly different illnesses? I think even if they are, many of us seem to have both.
Some people are devoted, really devoted to tearing up these reports presenting. (I do NOT put Dr. Jason in that category).
I think some people are more comfortable seeing others as enemies. It’s tough to turn that off but it does not lend itself to objective analysis. It reminds me of Fox News quite frankly.
I do not see any cheese down that tunnel!
While I think the logic of many of the arguments against the IOM report are inherently flawed (see my comment above, I do think the debate is healthy both intellectually and politically. The only way we work out the intellectual issues we face is through debate. And in many respects, the dogmatists in our community play a sort of “bad cop” role to the pragmatists’ “good cop”, pulling the terms of the overall debate in our direction (see ACT-UP vs. HRC in HIV advocacy). HHS has made it pretty clear they are going to do whatever they think is best regardless of what the patients and even professionals in our community think, so the argument that we should all come together lock-step behind the IOM report is not necessarily correct.
But while intellectually and politically our hashing things out may have value, for individuals with a disease exacerbated by exertion the debate may come at an unnecessary cost. And what is particularly unfortunate is when some in our community imply that he or she cares more about other ME/SEID patients, or “gets” just how serious ME is (as opposed to those with whom he or she disagrees) or has suffered/had the disease longer and therefore his or her opinion is more valid.
So, debate away, I say. But consider if it’s worth the cost to your personal health. And remember: we ALL suffer too much from this disease. We ALL get how horrific it is. We ALL care about other ME/SEID patients just as much as you do. Trust me. If you wanna play the “I get it more/I’ve suffered more” game, 8/10 times I’ll kick your ass at it, but there will always be someone worse off than me — and YOU!
Brilliantly-argued piece, Cort,thank you.
Funny thing is, the IOM quoted Lenny Jason’s work extensively and were clearly much influenced by what he had to say. I wonder if they could have simply asked him to check their new definition on his data, which I presume wouldn’t have compromised their independence (clearly an important factor)
It is my view that Leonard Jason is perhaps the foremost researcher in the world in regards to matters that best define the groups of patients we want to study the most. I have the greatest respect for Dr Jason’s integrity and his desire to do the right thing. He is not one who is likely to compromise either his own work or undermine proper procedures. He is dignified and articulate, and his experience is vast. There is no one better qualified for the job than Dr Jason. He should have been the first to have been a member of the committee.
I’m confused. So if an experts signs a petition against the IoM process, it would be wrong to sit on the committee. But it is ok for him to give a presentation to it. And that committee should have consulted him beyond giving a presentation or accepting his input through the public comment part. And now they are criticized for not including him as a consultant.
And I think we are missing a big thing: This is not a popular vote. This is evidence based. 400 years ago, if you tried to develop a consensus of the whole body of scientists on whether the world is flat or round, you would have had the wrong conclusion.
Despite having proposed clinical criteria by experts published in journals, Jason’s very good studies comparing the effectiveness of them, they were and are not being used in clinical diagnosis. Something is missing. What’s missing is credibility. The IoM’s process has that credibility. It could come from a medical professional organization of certified experts on the disease endorsing a criteria (after a scientific process) and then teaching it to its members. We don’t have the latter, so we needed the former. And, any changes now will not have gone through that process, the result being rejection of the whole thing because the changes were not done by a group recognized as independent and making their decision on the evidence review.
The CDC must keep their reputation among scientists. So just picking the ME-ICC or picking the CCC because it is most popular or has a consensus absent the thorough, controlled and systematic evidence review will hurt their credibility. If we are ever to have our disease, our doctors, our researchers be respected, we must stop saying, “Bit the rules of determining scientifically based truth for other diseases don’t work in our disease.”
And, we’re forgetting money. Any process requires money. Even with 15 on the committee and the public comment, it cost $1 million. Whose going to fund a much larger initiative with more engagement and inclusion of more?
I would ask any of our experts, when asked by any government, to participate in their process for coming up with changes in any area of our disease to participate. And if in the process, they disagree, they can remove themselves and announce why. I know the IoM allows a dissenting opinion to be included in the report, even though they aim for consensus.
Government has the money and power. Bring your expertise in so that what they do doesn’t harm. It’s a fallacy to say we can make progress without that power. If we had a strong medical professional organization of certified experts, or if our disease was embraced by one of the existing specialty medical professional organizations, then the government’s power over our disease would be less. We don’t have that. And there is very little power (as seen in lo these 20+ years) for clinical care to be changed by individual studies or published proposed criteria in the medical literature. It’s not enough.
You brought up so many good points (that I had not thought of….darn)..
Particularly these
“It’s a fallacy to say we can make progress without that power. ”
We have to get inside because that’s where the money is, that’s where the tools are and that’s where the top researchers are.
“If we had a strong medical professional organization of certified experts, or if our disease was embraced by one of the existing specialty medical professional organizations, then the government’s power over our disease would be less. We don’t have that.”
Nice point! Hadn’t thought of that.
Tily, we have an expert group — as established as rheumatism or autism. It is called the IACFSME. It did this work in the CCC and ICC. The whole point of P2P and IOM was NIH’s need to dimish this disease, which has to do with Anthony Fauci. I recommend Jeannette Burmeister’s excellent blogs on the papers disclosed by FOIA (which she had to undertake a long and expensive suit for, just to get NIH to obey the law.)
By the way, the list of experts who reviewed the report did not, as you seemed to think, in any way endorse it. Read the text around the list. It says none of them endorsed it or its conclusions, and that they did not see the pre-publication report. Also, none of their notes or criticisms will ever by seen by you or anyone “to preserve the integrity of the deliberate process.”
Lenny Jason did fine to pass on the committee. For one thing, I don’t see that he or his important work would have gained from wasting time flying to Washington and sitting through meetings when it was a foregone conclusion that the IOM report could not possibly the disease in that format of discussion — that has never, ever been the way diagnostic criteria are done except until 2013, when IOM was used to extinguish the Gulf War Disease. Remember, Lenny also has to manage this disease. I can’t think of a surer way to waste energy and crash then for him to have joined the committee. As is a lot of fine people spent a lot of time on something that was inherently impossible. There are things IOM does very, very well, but it was not a suitable format for this assignment, and no other disease has ever before seen its professionals treated so contemptuously.
In addition, the committee had two behaviouralists on it who should have been able to execute statistical analysis as well as he. And ability to hire consultants, as the credits indicate.
When the American Association of Neurologists speaks, the neurologists, and other medical professionals listen.
The IACFS/ME does a great service by putting on a conference every two years. But when they speak on this disease, no one else in the medical establishment listens. I hope their sponsoring a medical journal might help. But they did not take the lead in correcting the coding error in ICD-10-CM as the CFSAC recommended. Yet, proposed coding changes for other diseases were made by professional organizations for those diseases in the same meeting. Patient organizations had to do it for CFS, which is highly irregular. I don’t fault them, they must set priorities with the resources they have.
But, not having a certification program hinders their credibility when they speak. Neurologists are trained on neurological diseases. Who is trained on our disease? And how does the world know? Are so many years of experience or training required before a professional can be a member? If not, it’s just people interested in the disease, which does not make them experts in the eyes of the rest of medical professional society.
Here again, we can’t complain that the rest of medical establishment doesn’t accept as credible things about our disease when we don’t follow the standards of the rest of medicine, including having certified, trained experts in the medical professional organization.
And I agree that being a reviewer does not mean endorsement. But it does mean the committee benefitted from the suggestions and criticism of the reviewers. I have published a study before, and I can tell you, I made changes from the suggestions of my reviewers. I had six reviewers. And this report had many more. My point is this report included many of our experts either as committee members or reviewers. I don’t think we could have asked for any more and have it still fall into evidence based and standard scientific protocol standards.
Did you read the reports Deborah or have you just read Jeanette Burgmeister blogs? I don’t recognize what I read in what you are saying.
The P2P report called for a vast extension of the ME/CFS program at the NIH. Among other things called for increased research funding – and listed many research areas, research networks, Center’s of Excellence, career paths for ME/CFS researchers, programs to get young researchers into the field, concentrated efforts to resolve the definition problems, efforts to develop validated outcome factors, efforts to get the ME/CFS into medical school curriculums and more…
Where do you see diminishment in that?
I have voiced my opinion more than once at IACFS/ME Symposiums that there should be a definition of what a CFS/ME might be. Therefore, this not a new topic, but it then behooves us to come up with a way of accrediting people as recognised experts, so that such experts are appropriately recognised.
Hmm… please name one other known biological disease where a person having a psychiatric disorder of any kind precludes them from also having that biological disease.
Stumped? Yeah, me, too.
Don’t people who have mood disorders or other psychiatric ailments have enough problems, without being denied a proper medical diagnosis? How would any psychiatrist be able to properly treat a patient who had both depression and SEID, if they didn’t know their patient had SEID?
And why would you ever think that is okay?
Tina (sorry, I botched your name in the prior comment,) you poor innocent, no way was this evidence based, though it was “evidence-based.”
Study the bibliography. They left out all but one of the considerable body of evidence documenting the existence of encephalomyelitis. They excluded all the early epidemiology. They included the totally fraudulent work of the PACE trial. It wasn’t the fault of the people on the committee; it was arranged for by NIH.
The reason CBT and GET keep cropping up despite the destruction wreaked by GET is that Wessely and White had a great strategy for manipulating the bibliography. They also are good at press. They are very smart and very determined — with CFS they are rich and famous, without it they are pathetic academics who have never done an accurate day’s work in their lives. IOM did not have anyone to put up warning signs for them.
The early ME studies have been long superseded by later studies that used statistics. We’re just not in that world anymore – and using anecdotal reports to devise criteria when they statistically based analyses available – would have left the report open to ridicule.
I don;t think you’re giving our experts – people who have devoted their careers to this illness enough credit. I think they know the warning signs and they also know the literature.
Given that the report stated ME/CFS is a real and serious physiological disorder I don’t understand what the concerns are. The report did not endorse CBT or GET as a cure. It did say research is needed. It did validate physiological problems.
It has considerably raised the public awareness of ME/CFS as a serious and real disorder.
Given all that, what is in or not in the bibliography is a non-issue for me…
I’m having trouble believing Wessley, etc. influenced bibliography or any of this report. They have criticized it. Their supposed treatments were in the report as their being no evidence they work.
And I would argue that there does need to be a cut off date for what evidence they accept, both in how rigorous it is and the date. Would it be appropriate to include studies 70 years ago into MS when looking at evidence of MS? And a study of 300 or less in a disease of 17 million with such variability in age and symptoms, no biomarker, could certainly not be considered conclusive. I know lack of government commitment is why we don’t have that, well one reason why. But that doesn’t mean our studies with few cohort meets up to science standards.
In fact, I am concerned that they may have gone too far with the word “disease.” Oh, I’m glad they did. But I think what other doctors think is needed to prove “disease” has not happened in our disease. I’m not speaking of my opinion. I’m speaking of they standards in mainstream medicine.
Jason’s work survived as valid studies in the tough IOM review because he is very rigorous on study design. A lot of other work was tossed in IOM’s evaluation of the literature for poor design. Poor design is more than sample size. With the British study, the PACE trial, there is a funny line to tread. It began with a decent design, but did not follow through on it when the criterion for being ill or being “improved” overlapped, which makes no sense at all. Decent design is not all that good, as their definition of the disease was rather subjective. However, the journal that published it has not retracted it (like all the XMRV work). I did not notice IOM making much use of the PACE trial conclusions, and they clearly went a wholly different direction in their own report.
IOM had a narrow charge, and they worked to that. The results show that AIYH viewpoints fell flat with the IOM, as they saw a real physical disease.
Collaborative processes are fine, but they have not worked to our advantage in the past, as we keep arguing among ourselves. Being believed, having this called a Disease, not a syndrome, are pretty large steps in my book. If Jason does not believe in the IOM process (which is used by other groups in the NRC, that is, other fields besides medicine), then he took himself off the committee. His work still stands, the psychologist in charge of community health studies.
I am not fond of his insisting on a collaborative process now, as if the IOM work did not happen. I would much rather accept what they did, and move on, getting people diagnosed, number one, and getting research studies awarded along the lines IOM outlined. Jason may already be writing another proposal, who knows?
And who will choose the “experts” in a larger group to hash it out. And, did we consider, that such an open and broad debate might actually allow for the strong psycho pushers to have more influence? How, by what process, could their “evidence” be rejected if not to have a core committee determine it doesn’t measure up? And, basically isn’t that what we had?
It removed us from fatigue? I though the top box on the diagnostic chart was fatigue.
From what Bateman said, or was it Clayton, the first requirement is loss of function accompanied by fatigue. So the requirement is not fatigue that people can have but still function. The requirement is big change in ability to function. Notice it didn’t say “caused by fatigue.” So while fatigue must be there, the emphasis of this requirement is loss of function. It could be that OI or cognitive problems is the cause of loss of function, as long as it is also accompanied by fatigue.
Secondly, they said there should be a new code for SEID that is not under “Fatigue.”
I fully agree with this!
“For now, though, let’s spend our very limited political capital where it can do the most good: on increasing research funding, getting Centers of Excellence and finding a home in an Institute.”
My pdoc said it all when asked about the IOM report findings. “Did they say what the etiology was?” Just like every smug psychiatrist that believes it’s psychological. He might start losing some business if it proves otherwise. Of course I had to bite my tongue so I can receive my nortriptyline and xanax… Bastard!