Discussion in 'General ME/CFS Discussion' started by Aerose91, Nov 12, 2013.
We ordered, I think it was, 500 from Invest in ME. That's the way they were doing them.
the online version is a PDF. Would there be an issue with having it printed at a local printer? I was under the impression the ICC primer was free to use (though the CCC primer wanted a small donation to IACFS/ME).
Of course I'm sure if anyone has money to donate, there must have been some costs involved in putting it together, but I forgot or wasn't sure who had done this.
The other difference between us and cancer is that, for many people, cancer is something that has an end, one way or the other. Most healthies have no idea what to do with people who are sick and stay sick, and that includes "legitimate" diseases like Lupus, RA, MS, diabetes, etc.
The issue would be in the cost. I was given my copy (bound and in colour), so I don't know what a local printer would charge.
I was just thinking that even discussing the validity of "this disease" in the thread title is the wrong question. There is no disease validity without an accepted biomarker. What we do have is very valid pathophysiology, some of which is undeniably disabling. That is a whole different question, and it has answers. We also have many distinct cluster outbreaks which fit an environmental model (that includes pathogens) more than the alternatives.
Pathophysiology is defined as “the disordered physiological processes associated with disease or injury.”
Pathophysiology presumes a disease state. It does not by itself define what that disease state is, its just a description of processes that cause symptoms and unperceivable problems (like slightly elevated blood sugar - its a problem but you wont perceive it).
We can show things are wrong, and are badly wrong. Yet the science is not evolved enough to give us a complete or near complete causal mechanism, and the loose definitions we have (with Oxford the worst) come with no guarantee they are right. Even the ICC, the best we have, may define several diseases, we just don't know. The only pure patient samples come from each and every cluster outbreak. There is no guarantee that, for example, the Royal Free Hospital outbreak patients have the same disease as Incline Village. They could be the same, or just similar.
How are you defining "disease state?" I find this definition of disease: "A disorder of structure or function in a human, animal, or plant, especially one that produces specific symptoms or that affects a specific location and is not simply a direct result of physical injury."
There is actually no agreed definition of disease or disorder, just common ones.
Pathophysiology is abnormal physiology causing harm, and often symptoms.
Try this definition:
The point is too many can argue about disease definition or validity. Hard objective abnormalities including physiological problems cannot be so disputed. So doctors might dispute the existence of ME, but they cannot dispute findings without looking like quacks.
But isn't a disease defined and validated by such abnormalities, including physiological problems? Is any complete causal mechanism known for the disease that we call MS or for cancer?
Diseases can indeed be defined by pathophysiology, but only if its either unique, or unique in combination with other factors.
Aside from the abnormalities present in the 2 day CPET and low bright cells I think every single one of our abnormalities is shared with other diseases. Both the 2 day CPET and bright cell deficiency are still under intensive research. I strongly suspect that either one or both these tests in combination might define ME for us, and do it so strongly that with some advocacy and time it will be fully accepted.
Type 2 diabetes is considered a disease. However I think it a syndrome - a collection of similar and overlapping diseases with similar physiology. In many respects the problems present in type 2 diabetes are really overlapping symptom sets shared in many diseases. Sometimes this is refered to as comorbities, but sometimes that just confuses the issues.
Cancer used to be one disease. Then we had this cancer, and that cancer. Now we have many different and overlapping types of cancer, each linked to specific problems such as genes or viruses.
ME may be the same. If it were fully accepted as a disease I think it possible it would later fracture into at least two types. This is even worse for CFS - aside from rampant misdiagnosis I think most CFS patients who do not have ME will wind up having one of dozens of different diseases. Fatigue and pain are the two most common of all symptoms, and we have both. For this reason CFS is probably a hodgepodge of different but not understood, or misdiagnosed, diseases. Many as yet undiscovered genetic disorders might be included in it.
All this is without mentioning EDS, or different types of EDS. How many diseases will that break down to?
My point is still that while many may disagree with ME, or ME/CFS or CFS as diagnoses, the objective physiological findings are very hard to dispute without the doctor sounding dodgy. That gives us validity as sick people, as disabled people, with a right to proper medical care.
In the meantime we need CCC (and preferably ICC) as research criteria so we can advance the science.
But the problem with the diagnoses has been the so-called lack of objective physiological findings. So once the pathophysiology is established, the disease is validated. A 2-day CPET can validate a diagnosis. The Workwell Institute is proving that every day.
The Workwell Institute is validating our lack of physical capacity, and hence disability. Its consistent with various CFS, ME/CFS and ME diagnoses. I think it might well be diagnostically definitive, but I don't think the right kind of study is done yet.
I suspect that if you put the 2 day CPET to most groups of experts and asked if its definitive of ME, think they would say its useful, suggestive, or possibly definitive, but not quite sufficiently validated yet to be fully definitive. In particular this research needs to be replicated on a large scale by researchers other than those at Workwell.
The low bright cell finding is also very strong, but a lot of that has yet to be published. It also needs independent replication.
These two tests together may well become what we need to fully validate ME. Its strong science. Its just not what many doctors and researchers might currently consider to be sufficiently strong for full validation.
The other thing that might happen, politically, is that if we can get doctors to do this kind of testing in their practice, then the consistent findings of abnormalities and disability might change their views on ME and convince them to take another look at ME. That would be a political win. That is what happened with MS. Widespread testing made doctors realize that something was seriously amiss and MS had to be considered a valid disease.
I am hoping other consistent markers will be found, and am very interested in the cytokine patterns Lipkin found in spinal fluid. I don't think that has been published yet, I am hoping we get it soon.
The point of this thread though is how do we get accepted validity. Disease validity is still controversial. We can easily get validity through the right kinds of tests though.
As I think @biophile pointed out earlier, our increased risk of lymphoma and the fact we respond very well to a lymphoma targeting chemotherapy (Rituximab) may also convince medical people and the general public. The next stage in that fight is due soon when the Phase 2 Rituximab findings are published. I am expecting good news there.
This thread poses the question, “Is there any literature to prove the validity of this disease?” The ICC presents the 2-day CPET as a test for PENE, the cardinal feature of ME, and that test is being used now to validate a diagnosis.
What groups of experts should decide whether PENE is definitive of ME? According to the ICC, PENE is criterial, and other symptom groups involved in a diagnosis (neurological impairments, immune impairments and energy production/transport impairments) are exacerbated with PENE.
PENE will only be fully validated when there are objective techniques to measure it, and its able to be demonstrated to be a key feature of a large cohort, or distinctive subgroup within that cohort.
This comes down to what is meant by validation. If this were validated in the eyes of the medical community then the vast majority of doctors would already be using it. The very question of this thread would not even arise.
A consensus criteria like the ICC or CCC do not validate the content. The content would, ideally, if we had funding, be validated on large controlled cohorts. That hasn't happened as yet. Its been a major stumbling block for us. Things are not replicated, studies are not done to properly validate claims .... there are no resources available to do these things. Similarly any new IOM definition would not be validated. The closest we have to this are various papers by Jason.
ME is still controversial. The ICC is still controversial. Being controversial does not make something wrong, it means there is substantive disagreement.
The tests we can do, especially the 2 day CPET, leave very little room for controversy. Its a slam dunk win one way or another. Either someone believes there is a problem, or they are revealed as being contrary to the hard facts.
I can imagine the kinds of questions many doctors might have about PENE, and here we are talking about the defining characteristic of ME, either in its current incarnation or as post exertional malaise in older definitions. Please remember that most of these people have never experienced it. You or I have personal experience, they do not, and they quite rightly want evidence for complete validation. Please also consider that generations of patients have been convinced that their PENE is just chronic fatigue, and most doctors were too.
Can you measure it? In what units? How do we distinguish it from fatigue? In what units on what lab test? What scan? If you are willing to accept subjective questionnaires, then how were those questionnaires validated? How do we know the results of the questionnaire are not an artifact?
The 2 day CPET is part of this, and so is research by people like the Lights. CPET measures work capacity i.e. physical functional capacity. The 2 day CPET measures a crash in work capacity following exercise. The biochemical shifts post exercise measured by the Lights (and others) give further information. On a case by case basis every patient who has these can and should demand recognition and their rights, regardless of whether or not their ME or CFS or ME/CFS diagnoses are recognized. I think a similar argument can be made for other abnormalities, including severe NK cell dysfunction.
I do think the IOM is going to claim their view is validated. I make the distinction between a claim of validation and substantive validation.
It doesn't help that medicine does not have double standards - it has so many contradictory standards that I am almost surprised some doctors don't have their heads implode. I do not want to start arguing about psychobabble and evidence based medicine here however.
In the end validation comes down to sound justification. There are now strong ideas in the medical community about what that means. None of our diagnostic criteria meet those requirements. They probably could if we had more funding and resources, but we don't. They might if the CDC does its research properly for their new research criteria, but they refuse to use the most important test, the 2 day CPET. Even the CDC study though may require further validation if the results are not highly definitive. Worse we might find ourselves, yet again, in a fight to discredit another botched government study.
In the absence of large-cohort validation studies, patients taking the 2-day CPET test are having their diagnoses validated now. You write as if this weren't already happening.
Please cite the sources for this, and please don't use the ICC as it doesn't do this. What we have validated is functional capacity, and hence we often meet the requirements for disability. That is not the same as validating ME. That is my point.
What these tests can do however is in-validate bogus diagnoses like somatization etc.
As you must know, the ICC Primer specifies the use of the 2-day CPET as a test for PENE, and the Workwell Foundation confirms that this test is being used to validate diagnosis:
Before the publication of the ICC, Staci Stevens described the early use of her protocol:
Dr. Snell comments on using a 2-day CPET diagnostically, with specific reference to ME:
Dr. Snell explains too that 2-day CPET results are used regularly in reports to confirm diagnosis:
Can you cite any evidence to show that the 2-day CPET isn't being used to validate ME?
Actually I can use the same quotes as you do. First, they confirm/validate energy deficiencies in individuals. That validates disability. That does not validate ME.
The claim that "Results are used to confirm diagnosis" may simply reflect that the energy deficits are consistent with a diagnosis of ME. That is not validation of an entire diagnostic category. This level of validation would be completely dismissed by most medical authorities when it comes to disease validation. Which is what we see.
Using this kind of thing to claim validity of ME would be classed as very low grade evidence. Most doctors practicing evidence based medicine, and those bureaucrats, HMO workers etc. who do this kind of thing will dismiss such a claim. What they cannot dismiss is the evidence for individual patients, which again reaffirms my point.
I am not arguing that I think the use of evidence in an EBM approached used this way is valid, I am arguing that is what we are facing.
Nor am I arguing that the 2 day CPET will not eventually be used to validate ME. I am arguing we are not there yet.
So we need to focus on individual results, not appeal to a diagnosis, in order to get validity in the eyes of medical practitioners, HMOs, insurance companies, bureaucrats etc.
CPET was first developed around 1963, or at least that was the year of the first paper cited on PubMed. Prior to that the acronym CPET was in use but referred to a specific infectious pathogen. This is old and well understood technology, so in individual cases it provides solid evidence of disability or impairment. While CPET is Gold Standard technology now, it can be argued that a 2 day CPET is not Gold Standard. I think we should be demonstrating that it is Gold Standard for ME, but that requires more study, more funding, more resources.
To solidly claim that CPET is either diagnostic of or defines ME will require larger controlled cohort studies with randomization and double blinding. We need to know both its specificity and sensitivity. We need to know that other disorders don't show the same results as a 2 day CPET ... though anecdotally we do have grounds for this as even MS patients do not show our problems according to (iirc) Snell.
The above arguments are based upon both an evidence-based view, and a scientific one.
From a political view there is another way to win. We get doctors to accept using the test, we let them see in large numbers what is wrong, and then the consensus opinion will shift. In the eyes of doctors ME will be validated, patient disability will be measured not guessed, and psychobabble for ME will be discredited.
We will get there. We are not there yet.
You asked for evidence to support the claim that patients taking the 2-day CPET test are having their diagnoses validated now. The Workwell Foundation and Dr. Snell in particular do claim to be confirming diagnoses for patients regularly using the 2-day CPET. Yet you argue that they are validating only disability. You seem to be disagreeing with experts now rather than with me.
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