#PwME4ICC Demand US Health Agencies Recognize Myalgic Encephalomyelitis as Defined by ICC

Nielk

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Finally, you mention how in your first years of illness you did not meet all the ICC criteria. The ICC criteria do include atypical ICC for those who do not meet all the ICC criteria.
This is exactly correct, The ICC provides for 'atypical ME' for those who fit PENE and 5, instead of 7, additional symptoms.

The IOM criteria do not have stated provisions for those who do not match all their stated symptoms. For example, I have heard from people with ME who do not suffer from sleep issues. They would not fit the IOM diagnosis yet, do fit the ICC because sleep issues are listed as an option.
 

alex3619

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It's not the reports that are in question, it's the resulting criteria which when flawed will adversely affect ME patients, as they have done for the past decades.
The major SEID flaws are present in CCC and ICC as well. It really does not matter what you do, doctors will get it wrong, because they approach it simplistically . If doctors always identified the symptoms accurately then all these definitions would be more or less equivalent for clinical use. Its different with research cohorts, there is no substitute for the ICC using standard unmodified definitions.

As I explained, with ICC you have one of two risks. A doctor can identify comorbid conditions which are treated as excluding ME, and risk missing out on dual diagnoses. This might be very common with supposed depression, in which the depression questionnaires treat ME symptoms as signs of depression, because they are similar. A doctor might also decide to ignore strict exclusion criteria and diagnose ME anyway, possibly leading to a dual diagnosis. So you can wind up with dual diagnoses, false diagnoses, and missed diagnoses.

While I do not recommend SEID I do see the advantage to broader criteria, especially when key post exertional symptoms are mandatory. However we can get that best, and with less confusion, by using the ICC but treating the exclusion list as only a guide.

Again, we need one or more easy and available diagnostic tests. The two day CPET is not enough.

As far as research ICC is concerned, I think much of our leading research is starting to use it, which is a big win, and much of the rest of the leading research is using CCC, which is near enough to a win. SEID should never be used this way, at least as the base definition is concerned.
 

alex3619

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For example, I have heard from people with ME who do not suffer from sleep issues. They would not fit the IOM diagnosis
Here you go, from the IOM report -
Patients with ME/CFS frequently experience sleep-related problems such as insomnia, sleep disturbances, unrefreshing sleep, and nonrestorative sleep (FDA, 2013; Fossey et al., 2004). These symptoms are included in all existing ME/CFS case definitions and diagnostic criteria (see Chapter 3). Unrefreshing sleep, or feeling as tired upon waking as before going to bed, is among the most common symptoms reported by ME/CFS patients, and only a small percentage of patients diagnosed with ME/CFS fail to report some type of sleep dysfunction (Carruthers et al., 2003; IACFS/ME, 2014; Jason et al., 2013b).
[My bolding]

A cross-sectional study of randomly selected patients found that sleep-related symptoms may become less frequent over the course of the illness
Furthermore -

Conclusion: Despite the absence of an objective alteration in sleep architecture, the data are strong that the complaint of unrefreshing sleep is universal among patients with ME/CFS when questions about sleep specifically address this issue. While PSG is not required to diagnose ME/CFS, its use to screen for treatable sleep disorders when indicated is appropriate. Diagnosis of a primary sleep disorder does not rule out a diagnosis of ME/CFS.
 

lilpink

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The major SEID flaws are present in CCC and ICC as well. It really does not matter what you do, doctors will get it wrong, because they approach it simplistically . If doctors always identified the symptoms accurately then all these definitions would be more or less equivalent for clinical use. Its different with research cohorts, there is no substitute for the ICC using standard unmodified definitions.

As I explained, with ICC you have one of two risks. A doctor can identify comorbid conditions which are treated as excluding ME, and risk missing out on dual diagnoses. This might be very common with supposed depression, in which the depression questionnaires treat ME symptoms as signs of depression, because they are similar. A doctor might also decide to ignore strict exclusion criteria and diagnose ME anyway, possibly leading to a dual diagnosis. So you can wind up with dual diagnoses, false diagnoses, and missed diagnoses.

While I do not recommend SEID I do see the advantage to broader criteria, especially when key post exertional symptoms are mandatory. However we can get that best, and with less confusion, by using the ICC but treating the exclusion list as only a guide.

Again, we need one or more easy and available diagnostic tests. The two day CPET is not enough.

As far as research ICC is concerned, I think much of our leading research is starting to use it, which is a big win, and much of the rest of the leading research is using CCC, which is near enough to a win. SEID should never be used this way, at least as the base definition is concerned.
I find it hard to take anything away from this other than ICC are preferable, which should result in a desire to sign the petition? :thumbdown:
 

alex3619

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This is exactly what we are already experiencing with the IOM clinical definition. Dr. Bateman is providing the cohorts for some of the new NIH funded "ME/CFS" consortia and she is suing the IOM criteria to select those cohorts!
This is only of concern under several conditions. First, what is the operationalisation of this recruitment? In medical science there is routinely the selection of patients WITHOUT exclusion criteria. What happens next is that strict exclusion criteria are then added.

In an investigative study with a big enough cohort for potential statistical significance, identification of subgroups might occur by comorbidity, or other abnormal findings.

If the NIH does not take these into account then we have every right to express severe concern. This is concern about the NIH protocols. Quite frankly if they were using ICC I would be only marginally less concerned, as I would still need to know how the selection is operationalised. How do I know they will get the ICC diagnosis right? Operationalisation of a study is where the theory meets the real.

Let me give two brief examples. I was rejected for an NK study because of possible type 2 diabetes. This is not because NK problems and diabetes are incompatible, but because a clean research cohort was required. They added additional exclusionary criteria.

Some psychiatric studies claiming to look into CFS and ME purport to use an ME definition, but upon examination they study used a severely operationalised version that gutted the ME definition to the point that two of the authors of that definition did not recognise it as the same, and went public on this. Yes, I am talking about PACE.

Details matter, and matter a lot. If the NIH fail to operate properly then I will be joining the chorus of those complaining about it.

The other issue though is that in deep investigational studies its about masses of data including underlying biochemistry. The issues with cohort selection are less important, but if not addressed will weaken the study. The NIH possibly fits here, and especially Ron Davis' study fall into this category. If a broader cohort is used then extensive subset investigation becomes very important, and this weakens the statistical power of the study.

The cautions are warranted, but they are cautions about these studies, and operationalisation of the definitions.
 
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alex3619

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I find it hard to take anything away from this other than ICC are preferable, which should result in a desire to sign the petition?
I am not saying do not sign it, and definitely not saying do not support the ICC. I am saying sign it for the right reasons, not the wrong ones. We need to develop a better understanding of what is happening. By attributing faults and intentions (as opposed to stating outcomes and risks) we risk having the petition, or any advocacy, greatly weakened in the eyes of the intended recipients of the final petition. So opponents of the petition can then cite, accurately, a lack of understanding of the issues. Its an own goal.

I am not sure if it matters much if the recipients are bureaucrats, doctors, scientists or politicians. Opposition to ICC will still use it against us if we let them. I have seen this with some of our medical research too ... scientifically good, even great, but politically falling short of the mark.

Petitions need to be short and simple if they are to work in a medical, scientific, or medico-political area. They should be actionable, with clear and possible goals. They should not use supporting arguments that are likely to be seen as irrelevant, vague or naive by those we send them to. I have had these debates over petitions before. We are winning, its not the time to weaken our advocacy.

Supporting the ICC is a great goal. We are getting better at advancing our goals. I want to see us become even more effective.

For example, an actionable goal would be to ask for a requirement that grant funding require the use of ICC in cohort selection, while leaving the possibility for multiple criteria in studies in which criteria are themselves being investigated. This would mainly impact lower quality studies, as many good studies already use ICC, or at least CCC. We only need one reason ... the most up to date and most recent research definition is the ICC.

PS Does anyone doubt there will be substantial opposition to adopting the ICC in the NIH from within the NIH?
 
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Nielk

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I am not saying do not sign it, and definitely not saying do not support the ICC. I am saying sign it for the right reasons, not the wrong ones. We need to develop a better understanding of what is happening. By attributing faults and intentions (as opposed to stating outcomes and risks) we risk having the petition, or any advocacy, greatly weakened in the eyes of the intended recipients of the final petition. So opponents of the petition can then cite, accurately, a lack of understanding of the issues. Its an own goal.

I am not sure if it matters much if the recipients are bureaucrats, doctors, scientists or politicians. Opposition to ICC will still use it against us if we let them. I have seen this with some of our medical research too ... scientifically good, even great, but politically falling short of the mark.

Petitions need to be short and simple if they are to work in a medical, scientific, or medico-political area. They should be actionable, with clear and possible goals. They should not use supporting arguments that are likely to be seen as irrelevant, vague or naive by those we send them to. I have had these debates over petitions before. We are winning, its not the time to weaken our advocacy.

Supporting the ICC is a great goal. We are getting better at advancing our goals. I want to see us become even more effective.

For example, an actionable goal would be to ask for a requirement that grant funding require the use of ICC in cohort selection, while leaving the possibility for multiple criteria in studies in which criteria are themselves being investigated. This would mainly impact lower quality studies, as many good studies already use ICC, or at least CCC. We only need one reason ... the most up to date and most recent research definition is the ICC.

PS Does anyone doubt there will be substantial opposition to adopting the ICC in the NIH from within the NIH?
Of course, there will be opposition. HHS refused their federal advisory committee (CFSAC) 2012 recommendation to work on criteria starting with the CCC. HHS refused the letter from 50 ME experts telling Secretary Sebelius to cancel the IOM contract and to adopt the CCC criteria as they all have in consensus. HHS refuses to use any criteria - no matter how accurate - which they don't create or sponsor themselves (when it comes to this disease - only).

So, should we just give in and do nothing? Is that how other groups like the AIDS groups forced any change at HHS?

Do we really believe that NIH will appropriately fund research for the disease at $250 mil a year? Yet, there are a few petitions demanding that figure from Collins - appropriately so. No one is telling protesters to stop protesting for appropriate funding because they are unlikely to get what they ask for.

Then, why is it that some of the same people are advising not to ask for accurate criteria because chances are HHS will never deliver?

You state that petitions should be short and simple - I think this petition is exactly that. It lists very clear goals that the signatories of the petition expect HHS to take. It explains the why and backs up with links to studies showing the issues with using the weak IOM criteria as opposed to the stronger, more accurate ICC.

In actuality, it is HHS who is lacking evidence as to the efficiency of the IOM criteria. They have not vetted nor tested this new definition - therefore they have no evidence that it works in selecting patients. In addition, they are using confusing terms such as CFS and ME. At times I have seen CFS or ME. They will not specify what entity their IOM/SEID criterion is defining.

That is more of a reason of why we need a definition that distinguished ME - which we believe is best defined with the ICC.
 

alex3619

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You state that petitions should be short and simple - I think this petition is exactly that.
There is too much misleading information in the petition, which will send red flags to the NIH. Here is short and to the point :

We demand the US National Institutes of Health direct all relevant subsidiary funding bodies to require the latest and most up to date research definition for Myalgic Encephalomyelitis in any grant proposal, which is the International Consensus Criteria. (Ref)

Why does any agency of the US government that is giving grants for a medical condition allow out of date, obsolete, or non-research definitions into a medical condition, in this case Myalgic Encephalomyelitis? This is bad medical and research practice and needs to be urgently addressed.
When that is done you send another simple petition, so there is a campaign of simple petitions, each one brief and to one single point. If that point cannot be succinct, no more than a few sentences, and justified with facts not assertions, the petition should not be made.

For example, let me take the most problematic paragraph, and break it down -

In an attempt to mystify and marginalize this severely debilitating disease, government health agencies have misrepresented ME as part of an ill-defined chronic fatigue syndrome (CFS) (Reeves’, Fukuda, Oxford). The latest attempt at obfuscation by the US Department of Health and Human Services (HHS) has been sponsoring and adopting the recommendations by the Institute of Medicine (IOM) (now called the National Academy of Medicine) to use the name Systemic Exertion Intolerance Disease (SEID) and the IOM/SEID criteria. The IOM/SEID definition does not require any neurological or immune dysfunction symptoms and because of its lack of specificity will include many who do not suffer from ME.
As soon as you cite "attempt to mystify and marginalize" many agency personnel are going to leap to thinking "conspiracy theory". Rather than citing the history of bad decisions and funding choices, which are factual and speak for themselves, its presenting that history as part of a deliberate campaign. I do not doubt that there are many instances of deliberate misrepresentations within the NIH, but its not about the entire NHS. or even entire agencies. The closest to that would be the derogatory satirical letter to the CDC posted on a notice board and documented in Oslers Web. Or the letters between Strauss and others. Or internationally recognised experts walking out of the 1986 CDC committee in disgust.

This is further compounded by citing an "attempt at obfuscation". Its better to stick to the facts. The IOM report is the first large scale evidence based review using a methodology widely accepted within US medicine. It does have major problems, which could be targeted, but citing obfuscation again paints this as a conspiracy theory. Its not a good idea. It sends a message to patients, who are rightly disillusioned or furious at decades of government agency under-achievement, but it sends a message to the bureaucrats that we are just extremist conspiracy theorists and can be safely ignored.

"The IOM/SEID definition does not require any neurological or immune dysfunction symptoms and because of its lack of specificity will include many who do not suffer from ME." The petition cites a lack of neurological and immunological symptoms leading to low specificity. We simply do not know that. Its a risk, not a certainty. Furthermore the evidence based review process led to such claims being excluded as part of the definition, with some caveats ... that is that cognitive dysfunction, unrefreshing sleep, and orthostatic intolerance might be neurological, and that orthostatic intolerance can arise from an immune disorder. I know this review process was flawed, but that is because there is inadequate quality evidence according to modern accepted standards of review. These standards have flaws, but they are the standards we have to acknowledge before we can oppose them. This sentence makes far too many assumptions, and is unlikely to be taken seriously. Its the wrong approach. Instead we could point out that a proper evidence based review is problematic given decades of under-investment into research in this area. So any conclusions based on such a review are at best tentative.

HHS refused the letter from 50 ME experts telling Secretary Sebelius to cancel the IOM contract and to adopt the CCC criteria as they all have in consensus.
This is a very good point, and could have been emphasised more.


In actuality, it is HHS who is lacking evidence as to the efficiency of the IOM criteria.
They do, but they can say the same about ICC. Its not about that in the eyes of bureaucracy, from what I can judge. They will argue that is not their role, that as an agency they got the best review they could according to well established methods. That such methods are typically used on well researched and funded diseases will likely be missed by them.

In medical science its generally considered that consensus criteria are inferior to evidence based criteria, and that biomarker based criteria are the gold standard. We don't have diagnostic biomarkers, we don't have enough information published to reach a good consensus in a review like the IOM review, and in any case the most recent and up to date research criteria consensus view, the best we have, is the ICC. Consensus criteria like the ICC are about getting us far enough along to develop much more definitive criteria. SEID wont do that. Fukuda wont do that. The CCC is similar to the ICC but older.

There is a sleight of hand in the research discussion here. I am sure they will cite the lack of diagnostic biomarkers, but at the same time will ignore what we are now seeing in the science, the presence of hundreds of pathophysiological markers in every patient if enough of the right tests are run. No diagnostic biomarkers is conflated with no biomarkers in individuals, which is untrue.

The argument for the ICC is very simple. Its the only research definition for ME in the last decade, though I wonder about the revised CCC (2010). I have not looked into that recently. All other definitions are old and based on outdated science, or are not research definitions at all, like SEID. Why would any agency funding medical research allow obsolete or inappropriate research definitions in the studies they are funding?
 

lilpink

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When that is done you send another simple petition, so there is a campaign of simple petitions, each one brief and to one single point. If that point cannot be succinct, no more than a few sentences, and justified with facts not assertions, the petition should not be made.
I think you overestimate patient engagement and underestimate patient fatigue when it comes to signing petitions ad nauseam.
I agree with @Nielk that this is a very concise petition. Providing the correct information to the prospective signee and the intended final recipients.
 

alex3619

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I think you overestimate patient engagement and underestimate patient fatigue when it comes to signing petitions ad nauseam.
That is why reading a couple of sentences is much better than several pages, with links to further information if required. We, and many in the general public, often wont read through long discussions.
 

lilpink

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That is why reading a couple of sentences is much better than several pages, with links to further information if required. We, and many in the general public, often wont read through long discussions.
The information on the Petition isn't very long at all, especially compared to many other petitions that have been created for ME advocacy. The OMEGA petition had a great deal more information attached to it if you include numerous updates and I don't remember anyone ever criticising it on that basis. The Call for Change petition is also longer than the ICC petition. No one, other than yourself, has so far criticised the supposed lack of brevity on this petition as far as I'm aware. Multiple petitions are not going to work. Anyone who has ever created a petition will know this.
 

alex3619

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No. This is 'my' second petition. I get the sense you are trying to create an argument based on nothing.
It is not my idea to have multiple simultaneous petitions. It never was. I am sorry for not explaining but answering your comment literally, I should not reply when I am super tired. I tend to be literal and terse, and sometimes sarcastic. Sarcasm gets lost in text.

We need to up our game on petitions. Just repeating earlier tactics is not enough. Short and pointed is more effective. Secondary and supporting information can be linked. The main reason long explanations sometimes work from what I see is that they include attention grabbing hooks. Long is OK if you can hook the audience. I am less concerned about people already engaged in ME advocacy, than about bringing our petitions to others outside the core advocacy groups. Others wont read long petitions without some hook to get them interested. This can be a human interest story, for example.

My main concern with the current petition is not that it is too long, but that in being long it allowed argument that can actually undermine the intent of the petition. I have already explained this. One paragraph, already discussed, runs the risk of our intended target dismissing the petition out of hand. So do many demands. Decreasing the demands to the single most important, and not writing comments that can be dismissed by the less informed as conspiracy theory, makes for a much stronger demand, which might actually be doable. We have to remember that the target is government bureaucrats, plus scientists, plus doctors, though some are all three.

It would also be great to focus on that one demand and offer a path on how it might be achieved. Making it easier for the target audience is a better way to proceed. For example, we could try to get a commitment, again as I know its failed before, to bring the stakeholders together, especially leading researchers, and try to assess very narrow agendas. Broad agendas tend to get filed away. I think the number one for me would be require the use of ICC to get funding through government agencies. This alone would change the ME agenda though over years. Since its the most recent research definition there is literally no valid competition.

We are winning the ME medico-political struggle right now. I do not want to see that change.

I appreciate the goals you are working for, and agree with them, but we disagree on how to get there.

I think we do not need just more petitions. We need an organised petition campaign. This does not mean simultaneous petitions, it means a scheduled pre-thought series, indefinitely. As one petition is finalised we move into initiating the next planned petition. As this is underway we plan the next one after that. A series of very targeted rolling petitions, all very simple and easy to read, is where I am thinking we need to go. There might need to be a short break between petitions but there should never be a long one. There is already a lot of supporting material we can link to but we might need more.

This has been my plan for a long time, but I have been waiting for something very important to push for, and wanted to push it as a mainstream petition. Such as our researchers finding a diagnostic biomarker, and pushing for rapid development and rapid funding. Or finding a treatment, and pushing for funding for a phase 1 clinical trial and rapid development again.
 

Judee

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My main concern with the current petition is not that it is too long, but that in being long it allowed argument that can actually undermine the intent of the petition.
My understanding of what @alex3619 may be saying is regarding chosen advocacy, in the sense that when you go to court you hire a lawyer to represent you primarily because he/she knows how to speak the language of the court system so he/she will take your case and translate it to the judge etc in a way that hopefully works for both parties.

People have gone to court and represented themselves but usually with poor outcome.

I think what @alex3619 may be saying is that the language in this petition is our attempt to represent ourselves without vetting it through someone who has actually dealt with the process and the people in Washington D.C. etc.

For instance, I see Leonard Jason mentioned several times in these very long posts but wonder if he is aware of the petition. Has he signed onto this? I trust his opinion in issues involving our community. He has advocated for us numerous times. But just quoting him in reference to this argument is not going to convince me to sign this thing.

We are winning the ME medico-political struggle right now. I do not want to see that change.

I appreciate the goals you are working for, and agree with them, but we disagree on how to get there.
I agree with this. I think we as patients, ME or CFS, get frustrated with the process but we are moving forward, as little as it seems at times but I do want to be able to choose my own advocates in this battle.
 

alex3619

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the language in this petition is our attempt to represent ourselves without vetting it through someone who has actually dealt with the process and the people in Washington D.C. etc.
That is an interesting way to put it, but I think it captures the main point. CFSAC was of course created to bring these elements together, but its not proven very effective over the years. It would really help us to bring people who are experienced with the intended audience into advocacy efforts. The trouble is how do we recruit them? We have passion, we have an understanding of the many injustices, but we mostly do not have deep knowledge of our intended audiences.

If we just want to put pressure on, and not achieve anything much, then we can focus on just getting numbers for petitions. If we want to bring real change then we have to engage with the target audience as it is, warts and all. We also need to avoid using language that our opposition may try to use against us. I am not sure I like the use of the word opposition though.

Jason has actually written a book on community engagement for social change, and when I can read much again I hope to acquire it.
 

Nielk

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