Briefing on the Institute of Medicine report in Washington, D.C. --webcast March 25

[Sean]

The clear move away from the Oxford (and CBT/GET) in the IOM/P2P/AHRQ reports is a major win for us.

 

[usedtobeperkytina]

As has been reported, most studies use Fukuda. What criteria is used depends on the researcher's knowledge going in, what criteria he thinks will lead to discovery, and what the grant application reviewers require. Lipkin's was refused through an NIH review panel because the reviewer said it's not a biological illness. But I know another researcher who planned to use Fukuda but the reviewers insisted a severity test be included and those with PEM be subgrouped in the study.

Also, we are in a bubble, a loop. There is a whole world out there, including most researchers and doctors who never heard of CCC or ME-ICC. If they know anything, it's Fukuda. I may be exaggerating when I say "the world." Other countries may know these more. But in the US, relatively few have heard of either, much less understand them. Often, the get nothing about this disease in medical school. Why? No medical professional organization of trained and certified experts have endorsed and taught them.

I see no basis for this to change in relation to clinical use. And since the greater majority of research is done in Fukuda, the new SEID criteria with some disease exclusions added would be better. SEID requires loss of function, requires PEM and recognizes OI symptoms as part of the disease, all of which Fukuda doesn't. I am all for a narrow definition for research. I think I remember Jason's research calling into question the narrowness of ME-ICC.

I think symptom severity measures, requiring and verifying through a measurement PEM gets at the core of the disease.

 

[SOC]

I haven't read the context of those comments but they seem to be discussing mutual exclusivity.

Those are my comments and you are exactly right, Bob. We were specifically talking about mutual exclusivity. There was never any doubt in my mind that there is a subset of SEID (probably a majority, possibly even all) that fit the ICC definition of ME. If some people want to say ME is a more serious, or more neurological, or more whatever form of the illness than some other subsets of SEID, I won't disagree.

The comments quoted referred to the repeated insistence that SEID and ME are mutually exclusive, ie, if a patient has SEID s/he cannot possibly have ME and vice versa, a belief I find difficult to comprehend. It makes no sense scientifically and it benefits no segment of the population. It automatically divides us into two, entirely different patient groups with no common ground.

The fact that ME and SEID cannot be mutually exclusive does not mean that SEID patients who also meet ICC-ME should not be studied as an important subgroup of SEID patients. In fact, in terms of finding biomarkers and other critical features of the disease, I think it's critical that the most severe patients are studied first. I simply don't believe that the research done on those patients would not apply to less severe patients, which would be the case if SEID and ME are mutually exclusive.

 

[Valentijn]

I have been thinking about Fukuda. Its a research definition. So it might be that SEID wont replace it. What does this mean? Does it mean that SEID will sit alongside Fukuda?

It would be pretty crazy if they did. The research definition is supposed to be the stricter version, but Fukuda CFS is far broader than SEID. If that happened, we'd have a pretty strong basis for "Fukuda sucks" ... and maybe at that point a beefed-up SEID (perhaps CCC/ICC or essentially equivalent) could be used to replace Fukuda for research.

 

[Valentijn]

Perhaps the more important question here is: Do studies using the Oxford criteria have a disproportionate influence on medical and government policy?

Certainly seem to in some countries, like the UK.

Yes, even the P2P draft was giving a lot of weight to the results of PACE. It was really bizarre, since the same document was strongly recommending the retirement of Oxford.

 

[alex3619]

It would be pretty crazy if they did. The research definition is supposed to be the stricter version, but Fukuda CFS is far broader than SEID. If that happened, we'd have a pretty strong basis for "Fukuda sucks" ... and maybe at that point a beefed-up SEID (perhaps CCC/ICC or essentially equivalent) could be used to replace Fukuda for research.

If it replaces Fukuda, then either they have no research definition, or they envisage turning SEID into a research definition. Which might finally retire Fukuda for researchers all over.

 

[Ember]

Yes, but if this happens it will be blatantly obvious. It would be tampering.

The report will come with its spoonful of sugar.

 

[Ember]

Those are my comments and you are exactly right, Bob. We were specifically talking about mutual exclusivity.

Would you raise your same objections if ME and CFS were being discussed?

 

[alex3619]

As for definitions, exclusivity is based on whatever the group defining the definition decided on. It may not have any scientific merit. As for disease entity, we are operating in the dark. There is no hard evidence that proves they are not all the same, or syndromes with dozens of diseases within them, or anything in between. The reason to use highly specific ME definitions is primarily due to the benefits to research. The less specific a definition is, the weaker the resulting research.

The very best cohorts to choose for research have always been the outbreak cluster patients, as each outbreak is localized in space and time. Yet we have no guarantee that two outbreaks necessarily reflect the same disease.

Having said that the misdiagnosis rate is probably much higher for something like Oxford CFS (which I guesstimate at about 70% misdiagnosis rate) than ICC ME (for which I have no idea what the misdiagnosis rate is).

Oxford has very high sensitivity but very low specificity, but not enough has been done to be precise about these numbers. Similarly we have no good sensitivity and specificity data for any ME definition, and I am not sure we will until we have biomarkers.

PS When Oxford is operationalized to exclude lots of neurological signs then its sensitivity will drop considerably. In this case its a definition with low sensitivity AND low specficiity, making it about the worst kind of definition possible.

 

[caledonia]

@alex3619 I agree that research must be done correctly. To clarify (and I apologize for not being clear above) I was pointing out to @Caldeonia that sometimes just because studies say they used X definition, they may not really have done so.

This is true. There was a fair amount of customization or operationalization of definitions going on. But by far, the most common situation was using Fukuda straight up.

 

[Ember]

As for definitions, exclusivity is based on whatever the group defining the definition decided on. It may not have any scientific merit. As for disease entity, we are operating in the dark. There is no hard evidence that proves they are not all the same, or syndromes with dozens of diseases within them, or anything in between.

Patients argue over whether SEID is fish or foul, but the IOM Committee remains on the sidelines, apparently leaving ICD-10-CM to decide. Clark Ellis' upcoming article is expected to answer some of our questions.

 

[nandixon]

ME and CFS are classified as mutually exclusive ICD-10-CM diagnoses. Why does the IOM definition not exclude ME?

Would you raise your same objections if ME and CFS were being discussed?

You're conflating/confusing the old CFS (e.g., Fukuda), which doesn't strictly require PEM, with the new SEID, which does require PEM and is therefore no different from ME in that most important respect.

PEM is the critical defining symptom/sign of our disease. SEID finally makes that mandatory, like ME, but unlike CFS.

 

[Ember]

You're conflating/confusing the old CFS (e.g., Fukuda), which doesn't strictly require PEM, with the new SEID, which does require PEM and is therefore no different from ME in that most important respect.

No, I'm not conflating/confusing CFS (Fukuda) with the new SEID. I'm asking a question with reference to the ICC, one that I would have expected the IOM Committee to address. The ICC includes in its recommendations the CCC, a definition that also requires PEM:

“Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification;”

“Remove patients who satisfy the ICC from the broader category of CFS.... Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric.”

SEID is a renamed hybrid (ME/CFS) definition.

 

[nandixon]

No, I'm not conflating/confusing CFS (Fukuda) with the new SEID. I'm asking a question with reference to the ICC, one that I would have expected the IOM Committee to address. The ICC includes in its recommendations the CCC, a definition that also requires PEM:

The IOM essentially gave you your answer in the criteria they chose. They decided that the pain requirement of the two previously existing definitions for ME that strictly required PEM, i.e., the CCC and ICC, should not be an absolute requirement after all.

I actually don't totally agree with that, because even if not everyone with ME has myalgia, which seems to be present in about 75-80% of us, when you also combine this figure with patients who have headaches/migraines, we're probably getting close to 90% of patients having some form of pain.

Pain, I think, should have at least been mentioned with the criteria in some sort of qualified way. (E.g., "In addition to the above, many patients experience significant pain which may be in the form of myalgias and/or headaches or migraines.")

So the question isn't: Why didn't the IOM separate out ME? Because obviously the IOM believes ME to be a subset of SEID.

Rather, the question is: Why wasn't a pain requirement included in some fashion? And that is something that can be addressed separately without damaging the IOM report - which we absolutely need to use for leverage to obtain increased research funding.

 

[Nielk]

So the question isn't: Why didn't the IOM separate out ME? Because obviously the IOM believes ME to be a subset of SEID.

Where did you see that?

 

[Ember]

Rather, the question is: Why wasn't a pain requirement included in some fashion?

You're free to ask your own question. But don't presume to have answered mine.

 

[nandixon]

Where did you see that?

In the title of their report, for starters:

Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness

 

[nandixon]

You're free to ask your own question. But don't presume to have answered mine.

My apologies. I didn't realize you were actually asking a real question, as opposed to simply continuing to conflate the old CFS with SEID.

 

[Nielk]

In the title of their report, for starters:

Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness

They are referring to ME/CFS not ME.

 

[Ember]

My apologies. I didn't realize you were actually asking a real question, as opposed to simply continuing to conflate the old CFS with SEID.

I accept your apologies, but you misunderstand. I am not conflating or confusing CFS (Fukuda) with SEID.