The ICC for ME are finally published. What’s next?

by Johan on September 29, 2011

The paper “Myalgic encephalomyelitis: International Consensus Criteria” is finally published in the Journal of Internal Medicine (Volume 270, Issue 4, pages 327–338, October 2011), 2 months after it was accepted for publication. However, there is still a long way to go from a publication to scientific studies and healthcare policy based on these new criteria. The authors have made a great effort, but they only represent themselves. They do not speak for any healthcare or medical organizations, research institutes, or government departments or agencies. So you need to take the international and the consensus bit with a pinch of salt. In the article I will refer to these new criteria as ICC for ME or ME (ICC).

Oh no, not another set of criteria!

There are so many sets of criteria for CFS already and even the Canadian Consensus Criteria (CCC) for ME/CFS are, when used, referred to as CFS-criteria. Do we really need another set of criteria for ME/CFS or CFS? Well, we could. The CCC for ME/CFS were, and still are, my favorite criteria. However, it has proven to be an uphill battle over and over again for raising awareness because no journalist (or politician or doctor …) ever gets it that mentioning CFS without the criteria is lacking context, and data without context is just noise. The ICC for ME could be the game-changer we were waiting for because it doesn’t mention CFS. I am willing to make the ICC for ME my new favorite criteria, if they can become more than just a piece of paper. Right now, it is just the opinion of 2 dozen doctors and researchers and no one is bound to start using the new criteria, i.e. their work can be ignored.

What can we do?

What can we do to prevent that those criteria remain just a piece of paper? I have no idea if there is a procedure for this: from publication of new criteria for a disease to those new criteria being applied in research and healthcare. We could of course start writing to individual politicians and scientists, but no matter how polite those emails are, when their mailboxes get flooded by hundreds or even thousands of mails, it could have the opposite effect. It would be best if patient organizations take the lead: draft a letter, link it to an e-petition and ask as many patients as possible to sign it, before sending it off. I will give you some of my ideas:

  1. WHO:
    In the paper the authors claim the criteria are consistent with the neurological classification of ME in the World Health Organization’s International Classification of Diseases (ICD G93.3). The next step is obvious: ask the WHO to confirm this.
  2. Researchers:
    Ask researchers who have done or are doing studies on this disease to start using the ICC for ME, even if only in addition to the CCC for ME/CFS and the Fukuda criteria for CFS (CDC 1994).
  3. Institutes, universities and government agencies:
    Same as for researchers.
  4. CFIDS Scientific Advisory Board:
    Ask the members of the Scientific Advisory Board for their opinion on the ICC for ME, to start using the criteria in their own research, to convince their colleagues to start using them too, and what we patients can do to promote the new criteria.
  5. Doctor:
    Print the paper and take it with you to your doctor or even medical advisor. Ask them to read it and discuss it with you on your next visit.
  6. Journalists:
    It would be great if there would be a press-release available with a summary of the new criteria and how they relate to other sets of criteria.

No anti-CFS sentiment, please!

If you want to raise awareness for ME, then do so without trashing CFS. Three good reasons:

  1. Suppose the ICC for ME gets widely accepted. This probably means that between 30 and 50% of the patients formerly diagnosed with CFS based on the Fukuda criteria could be rediagnosed with ME. This doesn’t mean that those who don’t qualify for ME are not sick or that it is just in their heads. Clinically evaluated, unexplained persistent or relapsing chronic fatigue, post-exertional malaise, substantial impairment in short-term memory or concentration and unrefreshening sleep are but some of the Fukuda criteria. Raising awareness for ME yes, but not at the expense of former fellow- patients.
  2. Lots of patients are now already dropping the label CFS and outing themselves as ME-patients. Right now, the ICC for ME are just a piece of paper. No doctor, medical advisor, research institute, administration or government agency is bound to use them. Until they do, it is either the waste basket diagnosis CFS, or the ghost diagnosis ME. In Belgium you can get sick leave or disability based on a CFS diagnosis, but ME doesn’t exist here.
  3. Even if the new ME criteria get widely accepted on short notice, there is no research available. If you look at the time it takes for a quality study to get published in a respected peer-reviewed journal, I believe we may count ourselves lucky if a year from now the first couple of ME-papers will have been published. Until then, and even in the years to come we will have to rely on the 4-5000 biomedical papers on CFS to make a biomedical case for ME.

Trashing CFS is like shooting ourselves in the foot.

Belgium, a difficult country

Belgium is a difficult country. At the time of writing we still had no new government 470 days after the elections. The previous world record of 249 days was held by Iraq.
When I wanted to move one of my websites, a .be domain, to another registrar, some of the ones I contacted, told me that .be domains are difficult.

Raising awareness for the ICC for ME in Belgium will be difficult too, because we will have to do so without drawing attention to the Belgian co-author, prof. dr. Kenny De Meirleir.  He is considered a rogue and has put himself outside of the medical establishment, which regards his methods and treatments as unscientific and unethical. If we link the new criteria to his name, we risk that the very people we are trying to convince will dismiss the paper because of him.

PS: I have given the new criteria to my doctor. She has promised to read the paper and to discuss it with me on my next visit.

It is health that is real wealth and not pieces of gold and silver.
Mohandas Gandhi

{ 14 comments… read them below or add one }

Kassy September 29, 2011 at 8:16 pm

Thanks for the excellent, clear thought. I’ll give it to my local doctor as well. That sort of grassroots approach may be the most effective for individual patients. If I have one spoon and only one spoon, I’ll personally get the most out of it by using that spoon to feed the ICC to my doctor, who cares for two ME patients: me and my daughter, and who might also share it with colleagues. Then maybe the next time I have a spoon available, I’ll pursue something more global.

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Liz Willow September 29, 2011 at 9:23 pm

It’s been my plan to do exactly what you have laid out, Johan. However, like Kassy, I have limited energy so I will have to do what I can. But if everyone who has just a tiny bit of energy simply sends the link you’ve put at the top of your blog to someone on your list of potential recipients, I think we will make progress.

The big and very important difference between the ME ICC and the CCC is that the former is published in a journal that is indexed in PubMed. That means it will come up in searches for “CFS” or “ME” (as well as using other terms). This alone should gradually get it more attention within the research community.

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Willow September 30, 2011 at 4:27 am

Great suggestions, Johan; thank you. I particularly think it’s wise to go through organizations and petitions, rather than flooding officials with emails from individuals.

I have given the ICC to two of my doctors. :)

WillowJ

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Johan October 1, 2011 at 7:19 pm

@Kassy, @Liz Willow, and @Willow,
Thank you for commenting. I have received similar comments via Twitter, email and on Facebook. Organizations have a role to play, but in cases like this, individual patients can play a role too, and the good news is that they are doing it. A wise man once said, “That’s one small step for a patient, one giant leap for the cause”, or something very similar ;-)

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Jack January 21, 2012 at 10:59 am

Hi Johan,

Was reading this: http://www.nytimes.com/2012/01/20/health/research/new-autism-definition-would-exclude-many-study-suggests.html?pagewanted=1&_r=1&hp and it got me thinking again about whether ‘we’ too might face a similar dilemma?

I posted my concerns for those left out of the ‘pot’ etc. and a friend referred me to this post of yours from September last year.

I don’t think we have really considered the effect of adopting more stringent criteria for example or in terms of re-defining our condition and what it might mean for funding.

We assume I think that ICC ME will be ‘good’ and that ‘we’ will automatically ‘fit’ the criteria as well as it leading to ‘better’ research and treatment – but it’s an awfully big assumption.

And what of those that don’t make it as you said? Anyway, am a little late to post a comment I suppose though I did see the Norwegian Health Directorate have adopted the ICC ME – whatever the heck that means:

http://translate.google.com/translate?sl=auto&tl=en&js=n&prev=_t&hl=en&ie=UTF-8&layout=2&eotf=1&u=http%3A%2F%2Fwww.helsedirektoratet.no%2Fhelse-og-omsorgstjenester%2Fcfs-me%2Fdiagnosekriterier%2FSider%2Fdefault.aspx

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Johan January 21, 2012 at 11:34 am

Hi Jack,
The only prevalence rate I have seen for ME/CFS (CCC) was 0.11 or 0.12%. I have seen a prevalence rate of 0.19% for Fukuda CFS, but mostly it is estimated between 0.3 and 0.4%. This means that dropping CFS in exchange for ME would mean that between 40% to 70% of patients would be left out of the ‘pot’. This could mean losing all disability benefits or psychiatry all the way. Yes, lots of patients believe that they qualify for ICC ME and that a name change will make all the difference. Personally, I think that ME is a subgroup of Fukuda CFS and that defining subgroups in the patients who meet the Fukuda criteria is the step forward.
I have considered it and expressed my concern on a closed FB-group which recently dropped the CFS in it’s name, but everyone else is convinced they have ME. We’ll see.
We are living in interesting times.

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In Vitro Infidelium January 21, 2012 at 7:04 pm

Johan wrote: “Personally, I think that ME is a subgroup of Fukuda CFS and that defining subgroups in the patients who meet the Fukuda criteria is the step forward.”

That certainly tidies up a messy situation, but isn’t it a case of ‘the shrimp swallowing the whale’ ? The lack of any chronicity requirement in the ICC renders it incapable of distinguishing between Post Infective Syndromes, which may be of relatively short duration, and which may be wholly explicable in terms of infective processes, and – chronic illnesses which are more likely to have highly complex aetiologies. The prevalence of PIS type illnesses of unspecified duration (in theory any post infection debility which lasts longer than some notional averaged recovery time would fall under PIS) undoubtedly exceeds the prevalence of M.E/CFS (Fukada) by a considerable margin. ICC seems designed to identify PIS (and name PIS as proprietary M.E), therefore if one accepts the ICC as valid, then logically M.E/CFS would be a subset of PIS/ICC M.E, rather than the other way around.

Subsetting within Fukada seems eminently sensible; a decade ago Jason’s work may well have seemed reasonable and when matched against Reeves it stands out as the acme of nosological reasoning, but now both the CCC and ICC seem misguided projects. Those people backing the ICC appear oblivious to the simple statistical fact that no matter where you set the boundaries, under the circumstances where none of the criteria are fixed to a disease causing characteristic, there is no lesser probability of an individual who falls within the criteria, sharing an aetiology with someone falling outside the criteria, than with some else falling within the criteria. The argument that the more ill people are CCC and ICC are supposed to recognised severity), the more amenable their illness is to investigation is also not sustainable where multiple disease agencies are considered possible – someone who is more ill may simply be affected by a greater number of complicating disease processes, but not be more seriously affected by the disease process that is common to a larger group. Progress can only be made by comparing results from patients from all parts of the illness spectrum, not by redefining the spectrum with a priori reasoning.

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Johan January 29, 2012 at 9:25 pm

@In Vitro Infidelium,

Thanx for your comment. Sorry for the late reply, but thinking tends to be a slow process these days and you gave me a lot to think about.

Some additional reading:

  1. Review Article Myalgic Encephalomyelitis Case Definitions” [pdf] by Leonard Jason et al.
  2. Research1st: “ME Criteria Debate Moves to Journal Pages
  3. 2 links provided by Jack (below)

Here we go:

  • Agreed, I think the lack of chronicity in the ICC for ME is a drawback.
  • I usually refer to the Fukuda criteria as CFS criteria. I reserve ME/CFS for the Canadian consensus criteria.
  • As post-exertional malaise is not required for the Fukuda criteria I doubt the prevalence of ICC ME would exceed that of Fukuda.
  • Leonard Jason compared several ME (-like) criteria (Ramsay’s, London, Hyde’s Nightingale, Goudsmit and ICC) and found differences. Which definition is the real deal and matches the ICD 93.3 (WHO)? It is certainly not up to the authors of the ICC for ME to state that their criteria describe ME (WHO ICD 93.3). I think it is up to the WHO or whoever is in charge if these things, and I haven’t heard from them. Apparently, the debate on this (van der Meer, Lloyd, Broderick) has started which I consider to be a good thing. I have no idea where it will lead to though.
  • Is CCC ME/CFS a subset of ICC ME, or is it the other way around. The lack of chronicity in the ICC ME, would probably make CCC ME/CFS a subset of ICC ME. However, if I have read Jason Leonard’s review correctly, the “ME criteria select individuals with less psychiatric co-morbidity and mental health issues than the Canadian ME/CFS criteria.” Which I interpreted initially as that this would make the ICC ME a subset of CCC ME/CFS. I am not to sure about that now. One would have to make a side by side comparison of both sets of criteria and I don’t think I am up to that right now.
  • I agree with what you wrote about severity.
  • I have started looking at the ICC for ME as more of a theoretical exercise than of something with real practical value right now.
  • What would I do if I had anything to say in the design of the next study or studies (biomarker or treatment) into this disease? I think I would stick to the Fukuda criteria for CFS, but make post-exertional malaise required instead of optional. I would make sure that patients are also evaluated to see if they qualify for ME/CFS (CCC) or ME (ICC, Ramsey, …) and check whether the results of the study (biomarker or treatment outcome) can be matched against these different sets of criteria. It is the only way to verify whether the ICC for ME (or CCC for ME/CFS) have any real world value. And like you wrote “not by redefining the spectrum with a priori reasoning.”

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Jack January 22, 2012 at 12:00 pm

I still have problems with the name!
It doesn’t make sense to me that the Norwegian’s can ‘adopt’ this new set of criteria without having done any work on it/with it first.
I mean there is nothing to say that ICCME is even capable of standing on its’ own two feet – let alone that if rigidly applied (even without testing) – it actually applies to anyone currently diagnosed with ‘CFS/ME’.
We don’t know what testing would be carried out in order for people to receive this ‘new’ diagnosis either.
And I can’t help but feel that once again (perhaps) we are shutting the door after the horse has bolted and before it has been properly groomed!
As IVI has said, unless you take a large cohort of patients with existing diagnoses and properly assess them etc. then it cannot be enough to simply introduce a ‘new’ criteria and say ‘Well, I fit that. I have Myalgic Encephalomyelitis!’
The ICCME just as the CCC ME/CFS (I have noted that some folk tend to conveniently ‘forget’ the CCC implies both labels are one and the same) – need to be ‘sold’ to the regulatory authorities. And then would mean far greater study and legitimisation.
This – I thought – would surely have occurred in Norway before the Directorate could possible ‘adopt’ something like the ICC ME but it apparently hasn’t.
Also, when the ICC ME was ‘launched’ it barely caused a ripple in the millpond of medical-world. No one seemed interested (apart from some patients) and as a result it hasn’t been critically evaluated.
We don’t know from the authors just what they propose doing about this or indeed how if it were sold successfully – and added to existing criteria or even served to replace them or was seen as a ‘new’ criteria for an existing disease i.e. ME as opposed to CFS or even CFS/ME – existing patients would all be reassessed.
Yet from what I understand they are pressing ahead with some sort of ‘physicians guide’ to diagnosis.
The confusion that is my condition got even more confusing when these criteria were launched and I can’t see that they will be accepted even if they were to be included at this point in some research study – not accepted by those who need most to be persuaded as to their (and my condition’s) validity.

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Johan January 29, 2012 at 9:32 pm

@Jack,

Thanx for your comment. Sorry for the late reply, but thinking tends to be a slow process these days and you gave me a lot to think about. Initially, I was writing one reply to both your and In Vitro Infidelium’s comment, but I decided it would be best to keep ‘em separate. Some of the points I make will be similar.

Some additional reading:

  1. Review Article Myalgic Encephalomyelitis Case Definitions” [pdf] by Leonard Jason
  2. Research1st: “ME Criteria Debate Moves to Journal Pages
  3. 2 links provided by you (below)

Here we go:

  • A new definition or yet another set of criteria, the ICC for ME, wasn’t exactly on my wish-list for 2011.
  • What’s in a name? ME or CFS, there are arguments pro and contra for both names and I have started to dislike both of them. I will not repeat the ones against CFS, but ME is not a well-defined or well-known disease either. It is the disease with the 1000 names: ME, CFS, CFIDS, PVFS, Royal Free disease, Icelandic disease, Tapanui flu, … (and yuppie flu ;-) ). Is this one and the same disease? Or are they different diseases with similar symptoms? The more I read about it, the less I am inclined to spend energy on a name change to ME.
  • Leonard Jason compared several ME (-like) criteria (Ramsay’s, London, Hyde’s Nightingale, Goudsmit and ICC) and found differences. Which definition is the real deal and matches the ICD 93.3 (WHO)? It is certainly not up to the authors of the ICC for ME to state that their criteria describe ME (WHO ICD 93.3). I think it is up to the WHO or whoever is in charge if these things, and I haven’t heard from them. Apparently, the debate on this (van der Meer, Lloyd, Broderick) has started which I consider to be a good thing.
  • I live in a CFS-country (ME is not diagnosed in Belgium) as opposed to the UK as a ME-country. I would not be surprised if the results of a test to see if they qualify for ME might come as a shock to a lot of self-diagnosed ME-patients over here. Those who undiagnosed themselves as a CFS-patient and don’t qualify for ME; where would that leave them?
  • I have no idea how the decision to ‘adopt’ the ICC for ME in Norway was made. Is it a test case? Will ME be used instead of CFS? Dropping CFS and replacing it with ME does not make sense. Using ICC for ME for research purposes I can understand.
  • Yes, the ICC for ME might actually add to the confusion. It certainly adds to mine and I am a patient who knows more about this than the average doctor.
  • I have started looking at the ICC for ME as more of a theoretical exercise than of something with real practical value right now.
  • I am wondering which criteria the new and ongoing studies are using (Lipkin, Rituximab, …). I kinda doubt it will be the ICC for ME
  • Is the patient community making the same mistakes all over again with the ICC for ME as with the 2009 XMRV-paper? One publication and patients start campaigning. We should have learned by now that one swallow (one publication) does not make spring.

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Jack January 30, 2012 at 12:38 pm

Thanks Johan.

Never a need to apologise – it is always accepted that delays are par for the course.

Again, you raise some points that need raising and maybe haven’t before now. I continue to hope that the opening salvo from Van der Meer – whilst not wholly professional – will bring more debate to the fray from others, and we can take a more objective look at these proposals and where they ‘fit’ (if indeed they do) in the overall scheme of things.

Not sure if the NIH accepting ‘ME/CFS’ as their preferred nomenclature even helps matters. Once upon a time it would have been cause for celebration in the US I think – but now…. who knows? Am more confused than ever.

http://forums.phoenixrising.me/content.php?529-The-Biggest-Research-Funder-in-the-World-on-ME-CFS-The-NIH-on-ME-CFS-in-2012-Pt-I

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Johan February 9, 2012 at 11:39 am

@Jack,

Interesting document. I was waiting till part 2 would appear, but I just noticed there will be a part 3 as well.
Some highlights:

  • By using ME/CFS instead of CFS, the perception of how this disease is regarded by public and professionals might change. Think this is step forward.
  • Letting go of the Fukuda criteria. Means that more strict criteria like CCC, ICC, … can be used, but does this also open the door for more funding of studies based on Oxford and Reeves/empiric criteria? However ‘investigators should provide details of the case definition used’ and the NIH called for better study design. We will have to wait and see.
  • “Interestingly enough, the next NIH priority is on why moderate alcohol consumption causes such fatigue and debilitation in ME/CFS…” My first thought was ‘Is this a study funded by a brewery?’I am not picky as to where funding is coming from, but alcohol consumption isn’t high on my wish-list. Then again, at least one million people in the USA alone who would be able to consume beer again is not something to be sneezed at. ;-)
  • The list of ongoing studies in part 2 is impressive, and yet incomplete (Rituximab not mentioned).
  • Viagra for CFS study … let the jokes begin. ;-)

Confusing? Yeah, but also more opportunities. 2012 looks more promising than 2011. We live in interesting times.

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Jack January 25, 2012 at 3:04 pm

You have probably seen these already Johan:

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02468.x/pdf

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02499.x/pdf

Looks like we might be moving towards an open debate. Though I have to say that Van der Meer writes in an unprofessional style.

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Johan January 25, 2012 at 7:39 pm

@Jack,
Yes, I have seen those comments. Open debate is good. Van der Meer promotes GET and CBT, so a more restrictive set of criteria is not in his interest.
You and In Vitro Infidelium have raised some interesting points, which I am still contemplating. Will answer later this week.

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