The P2P Draft report is out

[Denise]

fwiw -
re is there a different version of the report coming out....
The response I received from ODP is that the terms "draft executive summary" and "draft report" are used interchangeably and that what is posted is what we are to submit comments on.

 

[Nielk]

If you get cut out then you do not have the same disease label anymore, you have something else. When a treatment comes about and gets approved, it gets approved for those that were studied in the trials, not those that have now got some other disease and got excluded, maybe years ago, and since have continued to be exploited by the psychobabblers. It's thinking which just assumes that things work out the way you'd like them to, totally ignoring the likely realities that would result from such a decision to cut these people out of the ME disease group.

This is not necessarily true. Take rheumatoid Arthritis for example. There is a large group f patients suffering from RA that are sero-negative. They receive the same treatments as the ones who fulfill the criteria of positive RA factor or positive anti-cpp. They suffer from RA based on their symptoms and they are helped by RA treatments.

In my opinion, if we keep ME and CFS patients together, we dilute the cohorts for research and we are not helping any group. Just look at the past 30 years of this mess. Where have we gotten? Nowhere!

I can't believe that 30 years later, we get excited by the fact that a panel has come to the conclusion that this is real? We are ready to look away from all the weaknesses of the report as well as the loopholes of the whole process?

Are we so starved for validation that we will accept crumbs? (or half of a baguette?)

 

[Iquitos]

Yes, Sing, that's exactly how I would describe this. They are trying to run to the head of the parade so they can claim to be leading it. Unfortunately, they are so far behind this parade, and have been setting up roadblocks to this parade for so long that it will take a long time for this change to have any meaningful impact, if ever.

 

[Nielk]

3. Remove the current CDC information on ME/CFS from the website and include the information in the physician toolkit that ME/CFS is not a psychological nor psychiatric disease in etiology and that treatment by antidepressants and other psychotropic intervention can cause harm to patients.

In what way does the draft report differ from the current CDC toolkit?

It currently states:

Chronic fatigue syndrome (CFS) is a complex and serious illness. The CFS toolkit was prepared to provide quick and easy-to-use resource for clinical care. It provides the best practices for diagnosing, treating and managing CFS. The approach may also be considered for people with CFS-like illnesses.

and later..

• [*]Treat clinical depression only. People with CFS may show signs of depression, but not have depression. Prescribing drugs for depression when a person is not depressed may make symptoms worse.
  [*]Use caution in prescribing/taking antidepressants. Some antidepressants may make individual CFS symptoms worse or cause side effects.

 

[Nielk]

This is not an easy issue. For years in the first seminar I gave to my clinical students I asked them what they meant by 'a disease'. By the end of the seminar they always agreed that they did not know. I would be interested to know what you (Large Donner and Nielk) mean by 'a disease'. Then we might see that we are on the same side. One of the problems for me is that this P2P report is written by people who think there is 'a disease' but I suspect that they have not thought what they mean by that. My feeling is that to solve the problems that PWME have we need to get a bit deeper. Having a disease name for financial purposes is something quite separate. Put another way, my impression is that what is needed most of all in this discussion is everyone being up front about what they are really trying to say because in the end, it will be plain as daylight anyway. I am well aware that some of my colleagues who recommend certain treatments are most at fault here. I think P2P need to decide what it is they are trying to say.

I am not a doctor nor a clinical student. I am a patient. In my teens, I was a patient who suffered from Crohn's disease. What did "disease" mean to me then? It meant that I felt sick most of the time. It meant that within ten years, I was hospitalized 15 times with blockages in my Ileum. It meant I had to be on constant dosages of steroids and azulfadine in order to avoid having to remove part of my colon.

In my late forties, I developed a fierce stomach virus, that lasted about a month. I developed extreme weakness, where I could not stand for 2 minutes. I could barely talk and sleep. I had a sore throat which kept getting worse at any attempt of functioning. I was dizzy a lot and developed cognitive problems with severe headaches. I have been disabled from work since then and have had to live mainly from my house and bed since then. I was diagnosed by a specialist in ME/CFS as suffering from this devastating disease.

What do I mean when I say "disease"? I mean there is something that is wrong in my body. My body does not function as it was meant to. What differentiates one disease from the other to me? It is the set of criteria.

If we treat a patient who is misdiagnosed with the wrong disease, it could be dangerous and at times fatal. Before I was diagnosed with ME/CFS, my gp said that I probably suffer from major depression and I should take anti-depressants. Not only did the anti-depressants not help me, it did a lot of harm. I am not alone with this experience. Many, ME/CFS patients had similar experiences.

One of the problems with criteria set by the CDC are that they include patients who suffer from clinical depression. I do not minimize the suffering that these patients feel. They deserve treatments and attention as much as anyone. But, the treatments for them will not be the same than for patients who suffer from ME/CFS or MEs as you call it.

I am concerned about having a set of criteria the financial purposes but, I'm even more concerned about setting a tight set of criteria that will have a better chance of finding appropriate treatments and possibly a cure.

 

[Jonathan Edwards]

I am not a doctor nor a clinical student. I am a patient.

And I think that is important. You accepted that you had Crohn's disease and then ME/CFS because doctors said that each of these was 'a disease'. (That obviously means something different from just 'disease' in the sense of feeling sick - this issue is what makes 'A disease'.) But if you become a medical student you have to learn what justification doctors have for these 'a disease' ideas.

Take Crohn's disease. Crohn described a syndrome of 'regional ileitis' - a pattern of symptoms and of inflammation of small gut. But doctors wanted to believe this was 'a disease' so they called it Crohn's disease - maybe assuming that it was probably due to some unknown infection a bit like TB. Then it became clear that the histopathology of regional ileitis was unique - a form of non-caseating granuloma. So the doctors said - aha! this is the disease that is caused through non-caseating granulomas of gut. And by then 'Crohn's disease' had a completely new meaning. It was the cause of the ileitis, not the ileitis itself. And you could now have Crohn's disease of the mouth, without any ileitis, because if there were the granulomas there it was obviously the same cause - so the same disease.

The end of the seminar was always realising that doctors are very muddled about what they mean by a disease but it is closer to a cause than an effect. It is often a particular code of DNA - maybe the DNA of a TB strain, or the DNA of a cancer clone, or the DNA of a defective clotting gene in haemophilia. But with a lot of diseases it is all a bit more complicated.

So if we look at the ICC document it is quite clear that the expert ME/CFS doctors writing it want to define some sort of causal process - probably 'neuroimmune'. They do not want just to define a syndrome of symptoms that often seem to go together - so they prefer ME, which implies a causal process, rather than CFS. But the trouble is that we aren't actually sure that the mechanism is neuroimmune - or that it is the same immune cause for all with ME. And if we look at the proposed criteria, they seem to be chosen in the hope that they will pick out a neuroimmune cause but nobody knows if they do.

So it is perfectly reasonable to focus attention on people with PEM but I think calling it PENE is a bit imaginative since we do not know what neuroimmune exhaustion would be. And since we do not know what it is it is hard to be sure PEM is a reliable sign of it. And the more you look at it the more it turns out to be a circular argument that relies on the belief that there is 'a disease' called ME. You cannot validate PEM as a criterion for ME if the definition of ME is something that causes PEM, but can do other things as well and occasionally not cause PEM unless you have good reason to think you can tell from case studies that you can pick out this special group by some other means.

Can the experts do that? My impression is not if you look at the criteria. These look like a list of criteria that doctors think ought to point to 'a disease'. In previous situations where there has been good reason to think there is 'a disease' on other grounds than just the features criteria have not looked like this because they have been selected on the basis of statistical analysis of their discriminant value (as in the ARA criteria for RA). Has any statitical analysis been done on the discriminant value of these ICC criteria? I doubt it because the gold standard is just the idea that doctors hope the criteria will reflect.

You are right to say that if we classify patients incorrectly they may get the wrong treatment but in fact treatments are often not disease specific. In inflammatory arthritis drug efficacy overlaps in all sorts of peculiar ways. The only one we really understand is that only seropositive RA responds to rituximab - which makes sense since rituximab works on antibodies. Seronegative and seropositive RA both respond to gold and methotrexate. So precise definition of this or that disease is not always the way to define treatments. We often want to use broader categories.

What I would like to see is all the experts in ME/CFS agreeing that so far the attempts to define disease have involved muddled thinking. Good treatment will rely on clear thinking. The trouble is that it may be complicated thinking and I apologise for that but if the doctors involved are to get things right we should not encourage them to oversimplify.

 

[duncan]

Well, Dr. Edwards, one of the reasons they picked ME may be as you suppose. But also because of its acceptance by the WHO, and because the historic documented symptoms of ME are fairly similar to those described by classic ME. At they same time, they discarded CSF because it was meaningless crap that did a disservice to the patient community on multiple levels that I won't rehash here. As should be the case with any medical research, this team chose to side, as best as it could, with the needs of both Science and a battered patient population.

Same thing holds true about replacing PEM with PENE. If you want to accuse the writers of the ICC of being imaginative for conjuring that label, you might as well applaud those who stuck the word Malaise at the end of post-exertional as something that could ever be remotely appropriate. So which is better? A label that denigrates and misrepresents a patient community, or one that may not prove out to be entirely accurate - yet still may? My vote goes to the latter with an eye toward mitigating the societal ramifications to the patient.

As to your point about not being able to validate ME using PEM if the definition of PEM is something cause by ME: I would politely counter that with the observation that it is done daily in the Lyme world with using EM to diagnose Lyme, even though Lyme can cause other symptoms, and sometimes (quite often, actually) not even the EM manifests.

 

[snowathlete]

This is not necessarily true. Take rheumatoid Arthritis for example. There is a large group f patients suffering from RA that are sero-negative. They receive the same treatments as the ones who fulfill the criteria of positive RA factor or positive anti-cpp. They suffer from RA based on their symptoms and they are helped by RA treatments.

In my opinion, if we keep ME and CFS patients together, we dilute the cohorts for research and we are not helping any group. Just look at the past 30 years of this mess. Where have we gotten? Nowhere!

I can't believe that 30 years later, we get excited by the fact that a panel has come to the conclusion that this is real? We are ready to look away from all the weaknesses of the report as well as the loopholes of the whole process?

Are we so starved for validation that we will accept crumbs? (or half of a baguette?)

Perhaps, but I think it's a bit different. With sero-negative RA you have visible symptoms, so are much less at risk from psyciatric poachers than with something like CFS.

I also agree that the process is very flawed. But we're in it aren't we. I used to work in processes management so I know when there is no point in fighting against a locked in process. I share your frustration over it though.

But anyway, I agree there are faults with the report too and I don't think anyone is suggesting we look away from its weaknesses; I haven't seen anyone say that actually. I certainly say quite the opposite - its very important we raise those things as issues and try hard to get them changed. But I also think we should see that some statements reflect a positive change in tone and that is a good thing.

Change never ever ever happens in one go. It is slow and stuburn, and this change in tone may reflect some upward movement from the bottom. It may not. But no change guarentees one thing only - no change. No change is always bad when you are at the bottom already. So this sign of change, even if not massive, could be important. I always get excited when change might be occuring.

 

[jimells]

The only one we really understand is that only seropositive RA responds to rituximab - which makes sense since rituximab works on antibodies. Seronegative and seropositive RA both respond to gold and methotrexate. So precise definition of this or that disease is not always the way to define treatments. We often want to use broader categories.

Which is why we need doctors with experience who can think and use intuition and have the time to do so.

Unfortunately we seem to be steady moving towards a system where one plugs symptoms and lab results into a computer which mechanically "decides" what treatments to use. We see this in the US with insurance companies deciding what disease a person has and what treatments they will pay for. These various lists of requirements for a diagnosis fits right into the diagnosed-by-computer model of "health" care.

The DSM is a caricature of this idea. If I have three of five symptoms from two of four categories I have diagnosis X but if I only have two symptoms from one of the categories then I don't. Seems rather arbitrary to me.

 

[Jonathan Edwards]

one of the reasons they picked ME may be as you suppose. But also because of its acceptance by the WHO,

As I undersand it ICD-10 has ME and CFS under the same code, and in the US CFS is regarded as based on epidemics just like ME in the UK. I think they chose ME because is implied a causal pathology.

Same thing holds true about replacing PEM with PENE. If you want to accuse the writers of the ICC of being imaginative for conjuring that label, you might as well applaud those who stuck the word Malaise at the end of post-exertional as something that could ever be remotely appropriate. So which is better? A label that denigrates and misrepresents a patient community, or one that may not prove out to be entirely accurate - yet still may? My vote goes to the latter with an eye toward mitigating the societal ramifications to the patient.

Except that malaise is just a bad way of describing a symptom that seems hard to describe better and neuroimmune exhaustion sounds scientific but I doubt anyone has a clue what it is supposed to mean. I can see that exhaustion might be of neuro-, rather than say muscular or metabolic origin, although that is uncomfortably close to saying it is psychological and not immune after all. And they want to keep the muscular and metabolic option in too. But neuroimmune exhaustion? I can understand neuroimmune inflammation but does this term actually make sense to anyone?

As should be the case with any medical research, this team chose to side, as best as it could, with the needs of both Science and a battered patient population.

But after decades of getting things wrong this way physicians have come to understand that criteria for disease classification for research should be entirely separate from those used in the clinic. Learning that was a long and painful process for the American College of Rheumatology. It turns out that this has been shown not to be what should be the case. I am simply trying to point out that it would be better for PWME if their advocates did not spend twenty years making the same mistake.

As to your point about not being able to validate ME using PEM if the definition of PEM is something cause by ME: I would politely counter that with the observation that it is done daily in the Lyme world with using EM to diagnose Lyme, even though Lyme can cause other symptoms, and sometimes (quite often, actually) not even the EM manifests.

Yep, but then you know what your disease is - it is what is caused by the DNA code of Borrelia species. The whole point of this discussion is that for ME the disease is 'X'. In mathematicians terms you cannot solve a set of simultaneous equations if you have more unknowns than you have equations. There is nothing to provide the gold standard. Everything becomes circular.

 

[Jonathan Edwards]

Which is why we need doctors with experience who can think and use intuition and have the time to do so.

Unfortunately we seem to be steady moving towards a system where one plugs symptoms and lab results into a computer which mechanically "decides" what treatments to use. We see this in the US with insurance companies deciding what disease a person has and what treatments they will pay for. These various lists of requirements for a diagnosis fits right into the diagnosed-by-computer model of "health" care.

The DSM is a caricature of this idea. If I have three of five symptoms from two of four categories I have diagnosis X but if I only have two symptoms from one of the categories then I don't. Seems rather arbitrary to me.

Yes, we have this with NICE just the same. Which is the main reason I resigned from my job because I could no longer treat people with RA sensibly.

 

[duncan]

Dr. Edwards, there is a lot of confusion out there by what is meant by CFS vs. ME. Also, you may wish to check your history as to how CFS got a foothold in the US. Yes, they are used interchangeably today, but eh, that was shoehorned in by sheer force of balderdash and political might.

Neuroimmune exhaustion makes sense to me. I assure you I am not trying to be difficult. I can see what they may have been trying to do. They were looking at the source/cause of the experience, and marrying that with patients' reports. I cannot speak well to the Science part, but from the perspective of experience, it's almost like the exhaustion one feels when the immune system has been switched on, but on top of that you can feel it in your focus, in your cognitive efforts, etc. You know how your tooth feels on novocaine? Well, how do you describe that to someone who has never had any dental work done? Similar to me trying to explain neuro-exhaustion. There is a mental aspect of it, but that is a sloppy word and dangerous, and it is wrapped and entangled in all kinds of psychiatric debris. One's brain is effected, and that translates into many many things, including thought and vertigo and neuropathies and emotion and pain. A real stew.

I hear your point about in Lyme there is a known "X". That is huge. Agreed. But when you really look hard at what constitutes that Gold Standard in Lyme, it's a fleeting whisp that only hangs around as long as a feckless rash, and then - poof! - no gold standard. (Because it becomes almost impossible to culture Bb outside of the EM rash) After that, the same parties - clinicians and patients and researchers - are left in a no-man's land, stuck hanging around with their hands stuffed in their pockets arguing over definitions, diagnostics and potential treatments. Sound familiar?

Oh, relative to separating research protocol from clinical? Yep, I hear you. I am certain you know the dangers of that as well - where the ivory tower can't mesh with the efforts at ground level and the resulting discordant atmosphere can sometimes strangle the patient. That's probably more true in Lyme than ME, but still. Regardless, I see your point.

 

[Bob]

You cannot validate PEM as a criterion for ME if the definition of ME is something that causes PEM, but can do other things as well and occasionally not cause PEM unless you have good reason to think you can tell from case studies that you can pick out this special group by some other means.

If ME were to always cause PEM, even if subtly, and if PEM was objectively measurable, then could it be validated as a criterion ME?

 

[Ember]

And if we look at the proposed criteria, they seem to be chosen in the hope that they will pick out a neuroimmune cause but nobody knows if they do....

What I would like to see is all the experts in ME/CFS agreeing that so far the attempts to define disease have involved muddled thinking.

I wonder why you think that the authors of the ICC picked out their criteria in a muddled way. One of the lead authors has said that they decided to develop these new criteria based on the accumulation of clinical knowledge and research. She mentions specifically the work of Drs. Snell, Light, White, Van Oosterwijck, de Meirleir, Kerr, Broderick, Klimas, Myhill, etc. Dr. Peterson, one of the authors of the CCC, advises clinicians to read the ICC because it emphasizes the presumed pathogenesis underlying the symptoms.

Surely the job of researchers is to test such presumptions. You write: “So it is perfectly reasonable to focus attention on people with PEM but I think calling it PENE is a bit imaginative since we do not know what neuroimmune exhaustion would be. And since we do not know what it is it is hard to be sure PEM is a reliable sign of it.”

Using the 2-day exercise test and the work of Drs. Light as tests, the ICC defines PENE as “a pathological inability to produce energy on demand with prominent symptoms primarily in the neuroimmune systems:”

The underlying pathophysiology of PENE involves a profound dysfunction of the regulatory control network within and between the nervous systems.36, 37 This interacts with the immune and endocrine systems affecting virtually all body systems, cellular metabolism and ion transport.38 The dysfunctional activity/rest control system and loss of homeostasis result in impaired aerobic energy production and an inability to produce sufficient energy on demand. A test-retest cardiopulmonary exercise study revealed a drop of 22% in peak VO2 and 27% in VO2 at AT on the second day evaluation.39 Both submaximal and self-paced exercise resulted in PENE. 40 These impairments and the loss of invigorating effects distinguish ME from depression.

Nobody would dispute your observation that more research is needed. But pathophysiology doesn't need to be fully understood before criteria are produced. You argue, “Precise definition of this or that disease is not always the way to define treatments. We often want to use broader categories.” Using broader categories, doctors have prescribed GET for us, and many of us have paid for their ignorance with our permanent disability.

 

[Jonathan Edwards]

Oh, relative to separating research protocol from clinical? Yep, I hear you. I am certain you know the dangers of that as well - where the ivory tower can't mesh with the efforts at ground level and the resulting discordant atmosphere can sometimes strangle the patient. That's probably more true in Lyme than ME, but still. Regardless, I see your point.

Sorry Duncan but you have missed that point completely. And probably the others, but no matter. It is all part of the debate I guess.

 

[duncan]

Silly me - I thought it was a discussion.

I'm sure you're right and I've missed all your points.

 

[Jonathan Edwards]

If ME were to always cause PEM, even if subtly, and if PEM was objectively measurable, then could it be validated as a criterion ME?

It would be validated as a criterion for ME if ME were to be defined as that which causes PEM. (This is where we have the circularity.) So really it would be like diabetes - a measurable clinical problem that did not need to have a cause-name to go with it. Everything would be simple - we would just be diagnosing PEM. I realise that sounds negative and I would love not to be but until we can find some reliable evidence of mechanism we are a bit stuck.

Though maybe it would be reasonable, as in fact it is now, to surmise that PEM has a cause that could be labelled myalgic, because that is a rough idea of the symptoms and could be called an encephalopathy at least, even if not an encephalomyelitis, so at a hypothetical level we may have an 'ME', or a few, to start doing science from. But I would worry seriously if that was used for an educational base for clinical practitioners and used to decide on treatment. That would be the 'ivory tower' applied to real people aspect.

All of this is trying to find some sort of compromise that allows people to say what they really mean. What we have seen from the psychiatric side is an attempt to say something quite different in therapy sessions from what is said at society meetings and dinners - and the cover has been blown. Even Sir Simon has admitted he was a bit tactless! I think we need a situation where there is no cover to blow. I can see quite a bit of cover in the P2P document and also in the ICC document still.

And what is interesting is that when I meet with the IiME people everyone is completely honest about what they mean and scientists and carers are on completely the same wavelength. Everyone knows where the cover is. And the result of everyone being honest is not painful because everyone is agreed that there is a real biological problem to solve - and that solving it is very hard and the best we can hope to do is to make fewer mistakes than before.

 

[Jonathan Edwards]

I wonder why you think that the authors of the ICC picked out their criteria in a muddled way. One of the lead authors has said that they decided to develop these new criteria based on the accumulation of clinical knowledge and research. She mentions specifically the work of Drs. Snell, Light, White, Van Oosterwijck, de Meirleir, Kerr, Broderick, Klimas, Myhill, etc. Dr. Peterson, one of the authors of the CCC, advises clinicians to read the ICC because it emphasizes the presumed pathogenesis underlying the symptoms.

That is the muddle. Accumulation of clinical knowledge needs to be backed up by statistical analysis of controlled studies on discriminating features - what for rheumatic disease was called the 'Delphi method'. Otherwise it is just doctors reminiscing coloured by their beliefs - we have a literature on all the pitfalls here. And basing criteria on presumed pathogenesis is a completely different idea - it is setting out a hypothesis. If you muddle hypothesis with data in science you are sunk. You cannot test a hypothesis with data that are gathered assuming your hypothesis.

Using the 2-day exercise test and the work of Drs. Light as tests, the ICC defines PENE as “a pathological inability to produce energy on demand with prominent symptoms primarily in the neuroimmune systems:”

But that is two effects, not a cause and an effect - inability to produce energy is a result and neural and immune symptoms are a result. The idea was that the neuroimmune bit is the cause. And there is/are no such thing/s as 'neuroimmune systems'. It isn't even good English. There is a nervous system and there is an immune system. Sorry but this is not a serious scientific analysis.

QUOTE="Ember, post: 537958, member: 1749"]Using broader categories, doctors have prescribed GET for us, and many of us have paid for their ignorance with our permanent disability.[/QUOTE]

But using broader categories we have established the value of methotrexate for inflammatory arthropathies and ibuprofen for pain. The weakness of the PACE trial has little to do with category width. It is that an unblinded trial with subjective outcome cannot provide reliable information. If the trial methodology was good then it would be perfectly acceptable as evidence for a broad group. Further study might show that only a proportion benefited but that would not invalidate the initial finding.

I can see that there are good reasons for using tighter criteria for recruiting to a trial of GET in particular. However, I am surprised about the enthusiasm for restricting the definition of ME in the practical clinical setting. Are people not worried that a large number of PWME are going to lose their disability benefits? A number of posters on PR seem to think PWME are going to be sold down the river with new tighter criteria on that score.

 

[duncan]

As we've established I can be a little slow at times, Dr. Edwards, maybe you can do a kindness and explain how PEM could have a cause that could be labeled myalgic (as opposed to a component)?

Also, I'm sure you are using circular reasoning correctly, but I would be delighted for you to explain how I have made another mistake. Circular reasoning does not necessarily invalidate the pragmatic effect of any given claim. I thought my comparison to using the EM to prove a Lyme diagnosis, when Lyme causes the EM was similar; it too employs circular reasoning, but it works...Same as a rash covering ones body might be useful in diagnosing chicken pox, even though the disease causes the rash. Isn't it the same as defining a bachelor as someone who isn't married, and then saying that by virtue of a man not being married he is single - isn't that also circular reasoning? Definitional or diagnostic logic does not necessarily fall into that logical fallacy known as circular reasoning where the claim is invalidated, i.e not all cases of circular reasoning lead to false assumptions.

Oh. Not for nothing, but as in Lyme, I'm pretty sure finding someone who doesn't have a cover to blow in the ME mess may prove to be a rare deed. Not counting patients of course, at least, not counting most patients.

 

[Large Donner]

Dr Edwards you responded to my post by saying you had previously answered my questions in other posts. I dont think this is the case. So I will post my questions again and ask some more.

your quote:

I am not at all suggesting using vague criteria for fatigue, except when it would be appropriate to do that.

Which is when exactly if you are not suggesting it at all?


your quote:

I think the P2P idea that variable criteria has wasted research is wrong.

Does £5 million on the PACE study justify this statement?

Yes or no.

your quote:

The waste comes from not thinking through the biological questions.

Yes but the whole point again is the assumption that most studies make any attempt to think through the biological questions and again the PACE study is a perfect example.

Do you think the the PACE study could have been spun the way it was if the patient selection was ICC ME and the cohort selection was independent of Peter White and co.

Yes or no.

I think you need MEs to be tackled as the six or twelve overlapping diseases they are. That is what the key researchers are all agreeing on now I think.

Im not sure what you mean by this when you take into account the experts letter to the NIH. Who are the "key researchers", by name, you refer to above that are not on the experts letter?

What evidence do you have of "six or twelve overlapping diseases they are."? Can you refer to me to any published literature?

Am I correct in saying that you are involved in the Rituximub IinME study.

Yes or no.

If that is the case do you know what criteria they are using?

What criteria would you like to be used for the study?


As I understand it, your point is that defining a disease via a criteria can end up in a circular process. One might say that is a reasonable perspective. However one might equally say back to you that if you don't have a single tight criteria you are yourself using circular logic by attempting to define a "set of 6-12 diseases" without tightly defining one single "syndrome".

Infact I would actually like to refer to this process as linear logic especially when we take into account your statement, "I think the P2P idea that variable criteria has wasted research is wrong".

We have faced decades of linear logic, maintaining the status quo that all and every criteria is equal and can be used.

The problem is who polices which defintion is used for each study that can be spun out in any way the PI likes. This is always the case in psych based studies. We simply cant go on with multiple defintions.

Taking into account that the IinME rituximub trial is being funded largely by patient donations I think its crucial we have a practical answer from you if you are involved that adds clarity to where you stand on the criteria debate.

The answer to your question, "what do i mean by a disease in terms of ME", I am talking about the disease defined using the ICC criteria and the one 50 plus experts signed off on in the letter to the NIH.

This is the main reason I would like you to answer to your statement........

...."I think you need MEs to be tackled as the six or twelve overlapping diseases they are. That is what the key researchers are all agreeing on now I think."

When you name the "key researchers" and point us to their published evidence then we can have a practical debate about such matters.