• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

Patients to DHHS: Fix the Broken ME/CFS Case Definitions NOW!

View the Post on the Blog

change-request-form-hi-238x300.png


On May 12 - International Awareness Day for ME/CFS/FM/MCS/etc - Phoenix Rising joined with 8 other US ME/CFS patient organizations and 26 independent patient advocates to call on the Department of Health and Human Services (DHHS) to finally fix the problem of the many and diverse case definitions associated with our disease. In a letter to Secretary Sebelius, Dr Howard Koh, Dr Thomas Frieden and Dr Francis Collins, we explained our concerns about the current definition activities of the DHHS in relation to "Chronic Fatigue Syndrome", and listed the steps we believe must be taken to rectify the situation.

You can read our letter to the DHHS here.

The signatories on the letter are:

Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago, CFS/Fibromyalgia Organization of Georgia, Inc., MAME (Mothers Against Myalgic Encephalomyelitis), PANDORA (a.k.a. CFS Solutions of West Michigan), Phoenix Rising, The Fibromyalgia-ME/CFS Support Center, Inc., Rocky Mountain CFS/ME and FM Association, Speak Up About ME, Wisconsin ME/CFS Association, Inc., Bobbi Ausubel, Rich Carson, Lori Chapo-Kroger, R.N., Kati Debelic, R.N., Mary Dimmock, Pat Fero, MEPD, Joan Grobstein, M.D., Jean Harrison, Eileen Holderman, Suzan Jackson, Jill Justiss, Mindy Kitei, Michele Krisko, Denise Lopez-Majano, Mike Munoz, Matina Nicolson, Donna Pearson, Leela Play, Justin Reilly, J.D., Mary Schweitzer, Ph.D., Meghan Shannon MS MFT, Marly Silverman, Rivka Solomon, Tamara Staples, Charlotte von Salis, J.D., Michael Walzer.

For those of you who wish to sign this letter and become a part of this important initiative, we will provide a mechanism to do that within a few weeks and will send out additional information at that time.



Why have we written this letter?

Of all the issues that we face today, the one issue that has created the most problems is the diverse case definitions associated with our disease. This single issue has severely impacted research, drug development and clinical care and misled the medical community on the very nature of this devastating disease, causing many doctors to not believe that their patients are really sick. Until this issue is addressed, patients will continue to pay the price. This must stop now.

Today, the CDC states that there are at least 5 different definitions for “CFS”. Three of these definitions - the Canadian Consensus Criteria, the ME International Consensus Criteria and the Pediatric Criteria - require hallmark criteria like PEM/PENE and neurological, immunological and energy production impairments. Unfortunately, two of the most commonly used definitions, Fukuda and Oxford, do not require these hallmark criteria. In fact, Oxford only requires 6 months of disabling fatigue - no other symptom - and allows primary psychiatric disorder.

The result? Myalgic encephalomyelitis, the disease seen in outbreaks throughout the twentieth century and recognized by the World Health Organization in 1969, has disappeared, and in its place we are left with “CFS”, an amorphous umbrella of unrelated fatiguing conditions including, according to the literature, depression, deconditioning, medically unexplained chronic fatigue, and for some researchers and clinicians, fatigue due to “excessive rest” or “false illness beliefs”. In clinical practice, the diagnosis of CFS is given to a heterogeneous mix of patients – those with ME, those with the varied fatiguing conditions listed above, and those who were misdiagnosed or whose doctors use the diagnosis of CFS as a catch-all for unexplained fatigue. And in 2012, an American Family Physician article proclaimed that Oxford and Fukuda are the appropriate definitions for “CFS” and further stated: “[CFS] patients with poor social adjustment, a strong belief in an organic cause for fatigue, or some sort of sickness benefit (i.e., financial incentive) tend to have worse responses to [cognitive behavioral] therapy.”

Exactly what disease are we talking about here?

Patients have paid dearly for the proliferation of these overly broad and non-specific definitions – bedbound or homebound, unable to work or take care of their families, suffering for 10, 20, 30 or more years from the myriad symptoms that plague their bodies, unable to get adequate medical care and ultimately more likely to die prematurely from cancer, cardiovascular disease and suicide.

As Dr. Carruthers stated in the ME International Consensus Criteria, “Research on other fatiguing illnesses, such as cancer and multiple sclerosis, is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME.” We must have a disease appropriate definition for ME that is separate and distinct from all the other unrelated conditions encompassed by the overly broad, fatigue-focused “CFS” definitions.


What are we asking for?

Our letter to the DHHS asks them to:
  1. Adopt a disease-appropriate case definition for ME now, utilizing the Canadian Consensus Criteria as recommended by DHHS’ own advisory committee CFSAC, and train doctors with appropriate medical guidance.
  2. Stop using the terms “CFS” and “Chronic Fatigue Syndrome” along with the non-specific definitions like Fukuda and Oxford and the medical education material based on these definitions.
  3. Manage the adoption of the Canadian Consensus Criteria to ensure that insurance and disability do not lapse and that no patients fall through the cracks.
  4. Fully engage ME stakeholders in the planning and execution of the adoption of the Canadian Consensus Criteria.
Is this the right thing to do?
QuestionMark4.jpg


You may ask whether we really know enough about the disease or whether we need more study before we change definitions. Certainly, with more study, we can better operationalize the definition and validate biomarkers to make patient diagnostics easier. But in the meantime, we know that PEM/PENE is a hallmark symptom that reflects a distinctive biological pathology and we must utilize a disease definition that requires that symptom.

Some of you may prefer the ME International Consensus Criteria over the Canadian Consensus Criteria. The ME-ICC certainly has some excellent features. But practically, the Canadian Consensus Criteria has been used clinically and in research for a decade. Studies have been done with it. The U.S. government has posted the IACFS/ME Primer, based on the Canadian Consensus Criteria, on DHHS’ Guidelines.Gov. This is more likely to be acceptable to DHHS and is a reasonable first step, especially when considered against the alternative of continuing to use Fukuda while more study is done.

What about dropping the name “CFS”? You may be concerned that this means we will lose the literature base that has provided insights into the pathology of ME. Admittedly, some of the best articles used the term “CFS”. And so do some of the worst. The point is that the literature base is a mess because multiple diverse and unrelated definitions have inexplicably been allowed to use the very same name for years. We all should stop using the term “CFS” because it no longer has any real meaning.

Finally, what about the name ME? Does it really describe the disease? Is there a better name? That is a question that science will need to decide over time, something that has happened in many other diseases. But what is clear is that “chronic fatigue syndrome” will never be an appropriate name and should never have been established as the alternative or synonym for ME.

Patients have borne the brunt of the failure to address the definitional issues for the last thirty years. We cannot wait for more study to finally stop the harm being done to patients, especially given that more study with non-specific definitions will only perpetuate the problem. The time to address this problem is now.


Questions and Answers

We realize that patients, carers and advocates may have a number of questions about this initiative, and we hope that the following questions and answers will address any concerns you may have.


1. We can not abandon the patients that have been incorrectly given a “CFS” diagnosis.

This is very true. It is critical that implementation of this change is carefully managed so that these patients are re-evaluated and given a correct diagnosis. If unexplained conditions remain, it will be necessary to perform the studies needed to understand these conditions and establish more appropriate names and definitions.


2. We can not afford to have our disability or insurance impacted.

Yes, this is very important. It will be important to have a carefully thought out implementation plan that manages this to ensure that patients do not lose disability or insurance benefits.


3. The vast majority of the 6000 articles in the literature use the name “CFS”, not “ME. If we stop using the name “CFS”, we will lose all that literature.

Currently, when the search term myalgic encephalomyelitis is used, the CFS literature is returned. This will not change. But that literature base contains both articles relevant to ME and also a significant number of articles about “CFS” and child abuse, false illness beliefs, deconditioning, etc. This creates significant confusion for anyone trying to use that literature. For that reason, the non-specific term “CFS” should be abandoned by the U.S. and more specific terms like ME used going forward.


4. We have more important issues to deal with such as funding, and attracting new doctors and researchers.

It is critical that we have more funding but if we don’t fix the definition issue first, we will continue to study the wrong disease and have progress impeded by poor definitions. The resultant confusion will make it difficult to attract young researchers and doctors who will not see career opportunity in “CFS”.


5. Research centers have recently been established and if we stop using the name “CFS” we will confuse our donors.

It is true that a number of research institutes have recently been opened and some of them use the term “”CFS” or even “CF”. But the donors to these institutes today have a personal connection to the disease. They will continue to fund. Attracting additional funders, however, will be negatively impacted by the confusion around the disease. The sooner we can resolve this issue, the better in the long run.


6. CFS biobanks have been established using Fukuda and we don’t want to lose those samples.

The biobanks that have only been characterized by the Fukuda definition could contain a mix of patients with the hallmark criteria of ME and those who do not have these hallmark criteria. Using these mixed samples will continue to confound research. It is important that we have a well-characterized set of samples in the biobank and know which samples are from ME patients.


7. ME may not be the right name. Shouldn’t we wait for the science to figure out what the right name is?

It is possible that with further study, we will determine a better name than ME and it will naturally evolve. But ME, adopted by the World Health Organization in 1969, is the best placeholder until that time and avoids the serious issues caused by the use of the term “CFS”.


8. The best course is to tighten up the “CFS” definition, not get rid of it. Then we can keep the literature base, the biobanks, etc.

There are two problems with this approach. First is the long history of the term “CFS”, which is non-specific and now widely associated with diverse conditions, especially including psychiatric issues. This has severely tainted the term and made it clinically meaningless. Second, the term “CFS” is used for those studying patients that meet Oxford criteria (essentially chronic fatigue) and we have little control over that continued usage.


9. Lenny Jason recently published a paper that reports that the ME-ICC and the Canadian Consensus Criteria include more psychiatric co-morbidities than the Fukuda and recommends that more study be done. Does that mean we should wait to recommend any criteria until then?

  • Dr. Jason’s paper did find that the ME-ICC found more psychiatric co-morbidity than Fukuda. But Dr. Jason acknowledged the need for more study because this one used a questionnaire designed for Fukuda CFS, and that they were unable to assess one of the key ME-ICC criteria because data on this criteria was not available. Further, the study did not look at homebound or bedbound patients.
  • But what is also significant in Dr. Jason’s study is that ME-ICC identified a much tighter group of patients (39 compared to 113 for Fukuda) with more of the functional impairments and physical, mental and cognitive problems seen in ME-ICC patients than in those meeting the Fukuda criteria.
  • Clearly additional study is needed to operationalize the definition and to improve how it characterizes the disease, especially around subtypes. But continuing to use the 19-year-old consensus-driven Fukuda definition - which is also not operationalized and does not describe subtypes - in the meantime is not going to advance that knowledge and will only continue to hurt patients.
  • The Canadian Consensus Criteria has been used clinically and in research for over 10 years and better represents the disease. Using the CCC now will allow us to begin to make forward progress in research and identifying treatments, and begin to address the disbelief in the medical community.
10. Is this the same thing as the Name Change initiative?

No. This is first and foremost about the definition being used – adopting a definition that effectively describes the disease and stopping the use of the definition – and name – that have created so much confusion and so many problems.


11. Why CCC and not ME-ICC?

The CCC has been used clinically and in a number of studies, providing the experiential foundation for its use. It is expected that as additional data is obtained, this definition will evolve. This must be done in partnership with the experts who developed the ME-ICC and the CCC.



We hope and believe that this initiative will be welcomed by the majority of the patient community, and we hope that the questions above have addressed any concerns. Of course there is always room for debate over details, but very few if any of us are happy with the existing definitional mess, and this letter represents a consensus amongst 9 patient organizations and 26 independent advocates on the best path towards change. As such, we encourage the community to get behind this initiative and seize this opportunity to resolve the problem of the broken case definitions used for our disease.




Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

There are many ways you can help Phoenix Rising to continue its work. You can even donate significant sums, at no cost to yourself, as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.


View the Post on the Blog
 
My specific thought is that some of these letters seem to be made public on day that they are sent. (Unless I am wrong about that?)
So perhaps Phoenix Rising could put such documents to a vote for one day only, in a members-only subforum? (And perhaps send the details out via email to attract members' attention to the issue.)
They're made public after they've been sent and received. They have to be signed (or not) before that.
 
Does Phoenix Rising have any time travelling technology that it could use? :alien: :alien:

While you are at it, go forward a hundred years and pick up some good books (are ebooks obsolete by then?) on the cause and cure for ME. Oh, and stock market tips. Photos of the latest Hollywood leading lady would be nice too. Lottery results?
 
Hi medfeb, RE

We've all seen how long research into ME and "CFS" has been going on without much effect because the criteria were so poorly defined.

As none of the criteria being used for research including the CCC are ME criteria, no research is being done on ME.

The CFS criteria are not poorly defined. They say that CFS has a certain set of symptoms, which are not caused by the many other diseases that can cause these symptoms.

The CFS criteria define CFS as a disease of exclusion!! All other causes of CFS symptoms must be excluded!

The problem with the CFS criteria, the CCC, and information provided by the likes of the CDC CFS toolkits is that the tests that they recommend to be done, do not exclude a large number of diseases that cause CFS symptoms, leading to large scale misdiagnosis.

We do not have a problem of what to do with a large number of CFS patients who do not fit the ICC. Because the majority of these patients have not had the diseases that can cause CFS symptoms excluded. Therefore they do not qualify for a CFS diagnosis and should never have been given it in the first place!

The solution to this problem is obvious and I have made both you and usedtobeperkytina and board members of PR aware of it.

The testing recommended by the Criteria and the CDC toolkit must be increased so that it actually does exclude all the diseases that cause CFS symptoms.

If the US CFS advocacy groups contact Dr Shiwan A Mirza who has written several articles on what is wrong with the testing recommended by the CDC criteria, such as

The myth of Chronic Fatgue Syndrome http://www.bmj.com/rapid-response/2011/11/01/myth-chronic-fatgue-syndrome

Chronic Fatigue Syndrome: NICE and CDC miss the boat http://www.bmj.com/rapid-response/2011/11/01/chronic-fatigue-syndrome-nice-and-cdc-miss-boat

The dogma of CFS, http://www.amazon.com/review/R28ZY8OYSWP0R

You will have a very highly qualified Assistant Professor of Internal Medicine, who will very likely provide you with real medical information that can be taken to the US government to ask them to increase the testing that is done before anyone gets a CFS diagnosis. It can also be requested that no research is conducted without first making sure that all patients selected have been extensively tested to rule out other diseases.

Instead of doing this, the letter that the US CFS advocacy groups sent. States that



“As a result, the term “CFS” has become an amorphous umbrella associated with a diverse set of unrelated conditions that include depression, deconditioning (5) , medically unexplained chronic fatigue, school phobia, and for some researchers and clinicians, fatigue due to “excessive rest”(6) or “false illness beliefs”(7). In clinical practice, doctors give a CFS diagnosis to a heterogeneous mix of patients – those with ME, those with the varied conditions listed above, those who have been misdiagnosed or those whose doctors use CFS as a catchall diagnosis for fatigue. “



Reference were included for the above statement in the letter that can be viewed here in full http://forums.phoenixrising.me/index.php?threads/patients-to-dhhs-fix-the-broken-me-cfs-case-definitions-now.23217/

The references for the above statement from the letter are

(5) Standing up for exercise: should deconditioning be medicalized?

http://jp.physoc.org/content/590/15/3413.full

This article from The Journal of Psychology implies that POTS in CFS might!! be caused by deconditioning. And fails to mention the many medically recognized causes of POTs.

(6) I strongly recommend that you might like to actually read reference (6) as it states

“It is of importance whether myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a variant of sickness behavior.”

http://www.biomedcentral.com/content/pdf/1741-7015-11-64.pdf

This reference does not apply to “excessive rest”(6) it is about comparing variants of sickness behavior caused by other illnesses! To ME/ CFS. It is not about excessive rest! How do the US CFS advocacy groups expect to get any kind of respect from the US government when they can’t even get their facts right?

Reference (7) Is a Publication whose principle author is Peter White of the Wessely School.

That states that CBT and GET are effective treatments for CFS http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/abstract

So I’m left wondering if it is the opinion of the US CFS advocacy groups that

1. CFS patients are mentally ill?

2. That the POTs in CFS is the result of deconditioning?

3. And that the Wessely School is right and all CFS patients should be given GET and CBT? After all the US CFS advocacy groups are asking for

“the adoption and proactive dissemination of appropriate medical guidance like the International Association for CFS/ME Primer”

Which includes sections on GET and CBT.

I would also like to know if Dr. Andreas Kogelnik the Medical Advisor for PANDORA is one of the doctors consulted about this letter.

All the best
 
Hi Bob, the US CFS advocacy groups, could avoid infuriating the people that they claim to represent, by, instead of putting the names of the various advocacy groups on these letters which implies that the people these groups represent have been informed of these decisions and are in agreement to it.

They could simply tell the truth and say that these are not the views of the patient population, as they have not been consulted; they are the views of the leaders of these advocacy groups. This small group of people should sign their own names to the letters, because by putting the names of the advocacy groups on the letters it gives the false impression that the patient population has been informed of and agree to the letters.

All the best
 
Perhaps it is interesting to note the comments pertaining to terminology - not definition per se - that were contained in the CMO report 2002 and in the NICE Full Guidelines. Viz. it's all the 'fault' of the Americans ;) :D

The term “syndrome” is widely used in medicine to encompass a variable pattern of disease, whether or not the syndrome has one unique causal mechanism.

“Chronic” indicates long duration.

For some, the term “fatigue” is problematic and considered demeaning because it is common parlance for the physiological experience of tiredness, whereas patients’ experience in CFS/ME is profoundly different. Also fatigue, though invariably present, may not be the major symptom.

“Myalgic” is similarly inappropriate for those patients with little muscle pain.

“Encephalomyelitis”, meaning inflammation of the brain and spinal cord, is incorrect because the term implies a patho-physiological process for which no evidence exists.

“Encephalopathy” has been suggested because this term lacks the implication of inflammatory change, while suggesting a significant focus of disordered function in the central nervous system.

The term “immune dysfunction” is unsatisfactory, because the relevance of observed abnormalities and an immune cause for the disease are not established.’

The Working Group decided that the most important requirement concerning terminology is the need for patients and clinicians to agree a satisfactory term as a means of communication.

A consensus on definitions and terminology is urgently needed.

Although a resolution is beyond the scope of this report, discussions are underway in the USA with international input, which will, we hope, propose a long-term solution acceptable to all parties.

While awaiting such a solution, the Working Group suggests that the composite term CFS/ME is used as an umbrella term and considered as one condition or a spectrum of disease for the purposes of this report.

This approach is consistent with our original terms of reference and ensures as far as possible an inclusive approach to our review.' p. 20.


‘The CMO working group called for a consensus to be reached on terminology and definition, and while awaiting this, suggested that the composite term CFS/ME is used and that it is considered as one condition or a spectrum of disease for the purpose of the report. This is the approach also adopted in this guideline. As a result of the report, the Medical Research Council was commissioned to develop a research strategy, and has made research on CFS/ME a priority.’ p. 68.


Much input of course from a WHOLE host of representative patient organisations on both the CMO Report and the NICE Guideline. The former influenced the latter of course.

So what can we take away from the above? CFS/ME is being employed as an interim term for the purposes of communication. America - sort yourselves out and we might follow suit. Until then you're playing catch-up it would seem.

Of course you can still argue that the ICC brings more to the debate that didn't exist before - which is the crux I guess of your arguments; I don't personally think it does and I don't personally think encephalomyelitis is the suitable term either.

That's just me though. Role on Rituximab. Talk about another potential spanner in the works :)
 
Am reviewing the CMO Report for something else, but came across another part that links in with my post above nicely:

'The issue of subgroups or discrete entities within CFS/ME was the subject of much debate by the Working Group.We are conscious that some sectors strongly hold the view that the term ME defines a subgroup within CFS, or even a distinct condition.

The Working Group accepts that some patients’ presentation and symptoms align more closely to the original clinical description of ME1 than to the current definition of CFS by the US Centers for Disease Control and Prevention.2

However, there is currently no clear scientific evidence to allow formal differentiation of ME from CFS on the basis of pathophysiology or response to treatment. Therefore, for the purposes of this report, we regard CFS/ME as a single, albeit diverse, clinical entity.

We hold the view that every patient’s experience is unique and his or her illness must be treated flexibly in its own right, from a range of options that are generically applicable to the disorder but individually adapted. This approach is similar to that for many other conditions.' p. 25.

Report of the CFS/ME Working Group to Chief Medical Officer (CMO) 2002

These are the 'attitudes' or 'conclusions' that one surely has to overcome in order to effectively sub-group an unknown section of the CFS/ME 'pot' into component parts.

I do not believe that either the CCC, this letter, or the ICC, effectively and succinctly achieve this.

Until such time as evidence is forthcoming, presented and accepted, that denotes the clinical existence of a defined sub-group based upon e.g. a biomarker linked to symptom presentation; only then will that Group be in a position to receive a different (or related) diagnosis with a (more) appropriate label.

'Myalgic Encephalomyelitis' is I think very unlikely to be that label. The objections raised in the past must surely be overcome with science and not through further playing with (even) consensus criteria.

FWIW :)
 
CMO Report 2002 said:
Although a resolution is beyond the scope of this report, discussions are underway in the USA with international input, which will, we hope, propose a long-term solution acceptable to all parties.

I hope that discussion was not what became the dreaded "Reeves" criteria which was a step backwards and stagnated the field. Here we are 11 years later with a new generation of "discussions underway" and a CDC multi-site study.
 
Am reviewing the CMO Report...
The Working Group accepts that some patients’ presentation and symptoms align more closely to the original clinical description of ME1 than to the current definition of CFS by the US Centers for Disease Control and Prevention.2

However, there is currently no clear scientific evidence to allow formal differentiation of ME from CFS on the basis of pathophysiology or response to treatment.
"The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions."
 
"The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions."
The reason why the CCC improved greatly on past criteria is that it makes PEM a hallmark of the disease.

I don't have an issue with making PEM a necessary symptom for inclusion. What I think is that the authorities will still demand evidence that is not yet out there: evidence that can also be linked to a specific population and that isn't a symptom which 'fluctuates'. The PEM in 'ME' needs to also be differentiated from PEM that may be present in other conditions. As I have I think said on this forum before - PEM does not appear unique. It may not have to - in may be that it's inclusion as part of the cluster of symptoms is sufficient. We still need though the evidence to swing the argument. Am just not sure it is there yet although several people are funding research into this exact area. IF PEM can be proven beyond reasonable doubt then we might have a test as well. Of course there are other studies that could also result in biomarkers and tests - but again we ain't there yet imo.
 
[...] What I think is that the authorities will still demand evidence that is not yet out there: evidence that can also be linked to a specific population and that isn't a symptom which 'fluctuates'. The PEM in 'ME' needs to also be differentiated from PEM that may be present in other conditions. As I have I think said on this forum before - PEM does not appear unique. It may not have to - in may be that it's inclusion as part of the cluster of symptoms is sufficient. We still need though the evidence to swing the argument. Am just not sure it is there yet although several people are funding research into this exact area. IF PEM can be proven beyond reasonable doubt then we might have a test as well. Of course there are other studies that could also result in biomarkers and tests - but again we ain't there yet imo.

I don't agree with your assessment, Firestormm. There is an enormous amount of medical and scientific literature on CFS and ME. All that has been missing is motivation and willingness, by the authorities, to make things happen.
You do not need to have conclusive biomedical evidence to formulate a set of criteria for a syndrome (CFS), or for a more specifically defined set of symptoms that may be a discrete illness (ME). Simple, old fashioned, medical observation will suffice. Indeed, a vague process of 'medical observation' seems to be what the CDC is doing now, for its new criteria project, although their methodology seems to be lacking in sophistication, considering the technology available to them.

The PEM in 'ME' needs to also be differentiated from PEM that may be present in other conditions. As I have I think said on this forum before - PEM does not appear unique. It may not have to - in may be that it's inclusion as part of the cluster of symptoms is sufficient.

Again, there is enough literature out there to define an ME patient who experiences PEM. It might not be an entirely exact science yet, but it is perfectly possible to start from a position of current medical and scientific knowledge, and then to build on this. That's what they do with other diseases.
 
I don't agree with your assessment, Firestormm. There is an enormous amount of medical and scientific literature on CFS and ME. All that has been missing is motivation and willingness, by the authorities, to make things happen.
You do not need to have conclusive biomedical evidence to formulate a set of criteria for a syndrome (CFS), or for a more specifically defined set of symptoms that may be a discrete illness (ME). Simple, old fashioned, medical observation will suffice. Indeed, a vague process of 'medical observation' seems to be what the CDC is doing now, for its new criteria project, although their methodology seems to be lacking in sophistication, considering the technology available to them.



Again, there is enough literature out there to define an ME patient who experiences PEM. It might not be an entirely exact science yet, but it is perfectly possible to start from a position of current medical and scientific knowledge, and then to build on this. That's what they do with other diseases.

Fair do's. Have to agree to disagree. It is exciting times in which we dwell. No doubt about that. I'd just like to see some quality, large-scale studies. Get some big-data. Not small-fry 'interesting' stuff.

If all these clinicians and scientists can convince the CDC - then great. If the advocacy organisations can come together and agree on 'something' - then that's great too.

Wish them all the best. I just can't see there's anything at the moment that will shift the balance. Plenty of things that might - but nothing outstanding that will.

I also have to ask myself what any of the proposed criteria changes will actually do for patients, you know?

Will I receive better treatments? Will it change any of the approach to management? To my care?

And what will be the impact on existing patient populations? Will it really impact them? Are we talking diagnosis or research? And when might all this occur? Are we talking a change in recruitment for trials that is drip-fed over the next 20 years?

Will GP's simply now ask 'Do you feel more tired after doing an activity?' etc.
 
Fair do's. Have to agree to disagree. It is exciting times in which we dwell. No doubt about that. I'd just like to see some quality, large-scale studies. Get some big-data. Not small-fry 'interesting' stuff.

If all these clinicians and scientists can convince the CDC - then great. If the advocacy organisations can come together and agree on 'something' - then that's great too.

Wish them all the best. I just can't see there's anything at the moment that will shift the balance. Plenty of things that might - but nothing outstanding that will.

I also have to ask myself what any of the proposed criteria changes will actually do for patients, you know?

Will I receive better treatments? Will it change any of the approach to management? To my care?

And what will be the impact on existing patient populations? Will it really impact them? Are we talking diagnosis or research? And when might all this occur? Are we talking a change in recruitment for trials that is drip-fed over the next 20 years?

Will GP's simply now ask 'Do you feel more tired after doing an activity?' etc.


I think that the impact on the patient population is great. The criteria that is used in studies and research is key to finding the right biomarkers and hopefully, eventually a treatment. It will help as far as finding the cause too. We could be investing a ton of money in research but if we are "apples" and they are researching "oranges" how will that help us?
It is not something that a patient will see an immediate impact on their life but, it will have an impact in the long run.
 
The PEM in 'ME' needs to also be differentiated from PEM that may be present in other conditions.
This quotation from the ME Primer refers to the ICC: "The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions." It's taken from the action plan that I referred to in my earlier post. The ICC uses PENE.

Here is the test for PENE:

PENE:
A 2 consecutive day comprehensive 8-12 minute cardiopulmonary exercise stress test (measuring heart, lung, and metabolic function) - only ME patients have significantly worse scores the second day & abnormal recovery from exertion.* Exercise tolerance test with expired gas exchange - (2 consecutive days) – measure cardiovascular, pulmonary & metabolic responses at rest & during exercise: peak oxygen consumption VO2 or VO2 at anaerobic threshold (AT) - decline of 8% or greater on test 2 indicates metabolic dysfunction, post-exercise blood analysis - increase in sensory, adrenergic and immune genes - increase in metabolite receptors unique to ME

Here is the definition:
A. Postexertional neuroimmune exhaustion (PENE pen-e): Compulsory

This cardinal feature is a pathological inability to produce sufficient energy on demand with prominent symptoms primarily in the neuroimmune regions. Characteristics are as follows:

1. Marked, rapid physical and/or cognitive fatigability in response to exertion, which may be minimal such as activities of daily living or simple mental tasks, can be debilitating and cause a relapse.
2. Postexertional symptom exacerbation: e.g.acute flu-like symptoms, pain and worsening of other symptoms.
3. Postexertional exhaustion may occur immediately after activity or be delayed by hours or days.
4. Recovery period is prolonged, usually taking 24h or longer. A relapse can last days, weeks or longer.
5. Low threshold of physical and mental fatigability (lack of stamina) results in a substantial reduction in pre-illness activity level.
 
This is PEM taken from the CCC


2. Post-Exertional Malaise and/or Fatigue: There is an inappropriate
loss of physical and mental stamina, rapid muscular and cognitive
fatigability, post exertional malaise and/or fatigue and/or pain and
a tendency for other associated symptoms within the patient's clus-
ter of symptoms to worsen. There is apathologically slow recovery
period…usually 24 hours or longer.

I wonder what the difference is in the PENE from the ICC and the PEM from the CCC? To me they sound the same except that PENE goes more into detail.
 
This is PEM taken from the CCC
This is the exercise test taken from the CCC: ”Cardiopulmonary Exercise Testing: AMA Guide for Evaluation of Permanent Impairment. Lower cardiovascular and ventilatory values at peak exercise help determine functional capacity, and peak oxygen consumption levels determine disability categories.”