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The P2P Draft report is out

PennyIA

Senior Member
Messages
728
Location
Iowa
Now I am thinking, why haven't they ever asked us about anger? We could show them some anger. Also, disappointment? How about disgust and outrage?

I know I've done my debate rounds with my doctor. And one of the net things that I repeat often is
I cannot imagine a single person who spends more than a year ill without a valid, treatable diagnosis, without a single, helpful treatment - let alone a treatment plan or tests that might reveal one... not getting sad. Yes, I have periods of sadness. I have periods where I wonder how I'll ever get better.

But really? How insane would you have to be to be facing that kind of a future and never be sad? Seriously? Those are the people you should be worrying about.

And having periods of being sad because I'm ill and not getting treated and with no hope for future treatment? That is not automatically depression. Sad is an emotion, depression is another illness. And sadness when you have a reason for it? Is healthy.

Sadly, this only works until the next time he sees me. I figure if I keep repeating it often enough it might make a dent in his assumption that anyone with chronic pain and fatigue MUST be depressed.
 

Nielk

Senior Member
Messages
6,970
I am glad they did not endorse CCC. CCC, while a good starting point, still does not reflect what we know now and what is needed:
Doesn't have a severity scale with how to measure levels of severity (needed for disability claims and research subgrouping)
Doesn't subgroup for treatments (infections, OI, etc. Also needed for more effective research)
Keeps "CFS"
50 experts in the disease seem to disagree with you. HERE. Yes, it is not perfect, but it is certainly better than the Fukuda. There is always room for improvement and refinement, but the experts have spoken and have chosen to adopt the CCC now. By refusing to accept this, HHS has snubbed every single expert who signed the letter as well as all the experts who have worked and penned the CCC. We all agree that the CCC could be improved upon and that is what the CFSAC recommendation suggested - to work on criteria, starting with the CCC.

To ignore this, is to ignore our experts.
 

Ecoclimber

Senior Member
Messages
1,011
Yes. Thank you, Bob.
I have no science background so, I am at a disadvantage at analyzing such things. I do not understand though why these findings (i.e. nk cell function, cytokine profiles, viral loads, neurological deficits) are not assessed as possible biomarkers for the disease. The draft starts out in stating that there are no biomarkers, yet there possibly are. We just need larger scale studies to prove it. The same goes for treatments. Rituximab and Ampligen might be treatments, we just need larger scale studies to prove it.


That's what this report is critically stating. The research is not there:

Do patients just skim over and pull out what they want or do they actually read the entire document. There is no mention of Fuduka in this document. They mention CBT/GET, depression as ancillary to ME/CFS. Every major disease has depression, anxiety etc. Is MS, Cancer a psychosomatic disorder because they include CBT/GET, and other alternative modalities to deal with pain? Will MS, Cancer become a psychiatric disease becasue they use some psychological and alternative tools to manage coping with these diseases? No

They ruled this is not a psychiatric, psychological, psycho-somatic disease...period. How many times does this have to be copy and pasted over and over again before everyone realizes they cannot then treat patients with these modalities as a primary treatment protocol when they have identified it as a biological disease? They stated as such in this report.

They are stating that the methodology of the research model is lacking. Why do some patients respond to Valcyte and others do not? Does anyone know? Why do some get better on Famvir and others do not? Why do some patients get better on antiviral medication and others do not? Why do some patients improve on Immune Modulators and others do not? Why do some respond to Rituximab and others do not? Why do some relapse and other do not? Why do some improve on antibiotics and other do not? What about enteroviruses or the Stanford fMRI find on reduced brain matter?

They want to know the answer to these questions.

To date, clinical research and trials the lack of inclusion of the homebound, rural residents, and a research focus on men. Minorities also are rarely represented in studies, so there are no data to confirm whether minorities have a higher or lower risk and treatments. Is this not correct?

Someone mention no PEM

Fatigue has been the defining focus of recent research, but many other symptoms need to explored, primarily neurocognitive deficit (“brain fog”), post-exertion malaise, and pain. Most ME/CFS studies focus on adults, excluding children with similar symptoms.

We noted unproven. Clinical studies have focused on predominantly Caucasian, middle-aged women. Is this not true? Representative, ethnically diverse samples across the lifespan are lacking. Investigations of natural history and familial linkages may identify genetic predispositions and lead to early identification and primary prevention. Some on the forum have mentioned how their children developed ME/CFS. Is their a genetic component or predisposition in a subset?

Carefully designed and adequately powered studies defining the spectrum of ME/CFS in urban and rural communities are lacking, limiting their applicability to an increasingly diverse society. Specifically, it is critical to include patients with limited access to clinical services (e.g., non-ambulatory patients).
Is this not true? Did not members of the patient community complain that researchers need to include patients who are bed ridden and housebound patients, the sickest of the sick, because they could not particpate in trials.


The symptoms patients consider clinically meaningful are not in the scientific literature; this discordance must be rectified. Is this not true? We know the psych model is included in scientific literature. Are we not upset that as a patient community PEM, is not included?

Some mention the lack of natural killer cell dysfunction is not mentioned. Read below.
An integrated, systems-level approach should be followed to understand how immunologic, neurologic, and metagenomic factors may contribute to ME/CFS. Immunologic mechanisms of ME/CFS and pathways associated with disease progression must be defined and characterized (e.g., defining cytokine profiles involved in pathogenesis; studying inflammation; and comprehending the basis for natural killer cell dysfunction observed in many patients with ME/CFS). These also should be longitudinal studies to explore the possibility of a progressive immune exhaustion or dysfunction in ME/CFS.

There are tremendous opportunities on which we have not yet capitalized to learn across disciplines and from other diseases such as Gulf War Syndrome, Lyme disease, fibromyalgia, multiple sclerosis, and Parkinson’s disease, to determine commonalities and differences.

What they are saying is that the research model is lacking in many areas to determine the size, scope and severity of this disease across the entire population involving all of the above metrics including the ones not mentioned in this post but were included in the report. The research that has been completed to date has not been robust enough, too small in number, too exclusionary for the sickest and is limited as to gender, ethnic and age specificity...Good Grief!
 
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Nielk

Senior Member
Messages
6,970
10 Unfortunately, ME/CFS is an area where the research and medical community has frustrated its
11 constituents, by failing to assess and treat the disease and by allowing patients to be stigmatized.

It is not the research and medical community that has frustrated its constituents, it is HHS! It is NIH that has denied funding into serious research. It is the CDC who refused to remove CBT/GET from the toolkit on their website. It is HHS who has refused to move on from their Fukuda Criteria. It is HHS who refuses to acknowledge PEM/PENE as the cardinal symptom of the disease. It is CDC who refuses to do 2 day testing...etc.
 

snowathlete

Senior Member
Messages
5,374
Location
UK
Line 281: "Studies investigating homeopathy [...] are needed."

What the...

I'd like to think that they are looking at this from the angle that these alternative treatments need to be put to the test in order to show that they fail - but that's not really how it reads is it. I'm still bemused by homeopathy in general, my wife's GP offered her it the other day. o_O
 

Nielk

Senior Member
Messages
6,970
Do patients just skim over and pull out what they want or do they actually read the entire document. There is no mention of Fuduka in this document.

I don't appreciated your condescending tone here. some of us might be more cognitively challenged than others. That is no reason to talk down to us. (me!)

Fukuda is not mentioned you say. I never said that it is but, by singling out Oxford for exclusion, it is understood that Fukuda is meant to stay in.
Someone mention no PEM

Fatigue has been the defining focus of recent research, but many other symptoms need to explored, primarily neurocognitive deficit (“brain fog”), post-exertion malaise, and pain. Most ME/CFS studies focus on adults, excluding children with similar symptoms.

I mentioned PEM/PENE - not as one of many symptoms but as the cardinal/mandatory symptom.for diagnosis.
Some mention the lack of natural killer cell dysfunction is not mentioned. Read below.
An integrated, systems-level approach should be followed to understand how immunologic, neurologic, and metagenomic factors may contribute to ME/CFS. Immunologic mechanisms of ME/CFS and pathways associated with disease progression must be defined and characterized (e.g., defining cytokine profiles involved in pathogenesis; studying inflammation; and comprehending the basis for natural killer cell dysfunction observed in many patients with ME/CFS). These also should be longitudinal studies to explore the possibility of a progressive immune exhaustion or dysfunction in ME/CFS.

I am talking about NK cell function levels as a possible biomarker not just a finding.

What they are saying is that the research model is lacking in many areas to determine the size, scope and severity of this disease across the entire population involving all of the above metrics including the ones not mentioned in this post but were included in the report...Good Grief!

And I state that I am angry that HHS has spent my tax money to be spent on a process that results in a report that states what has been obvious to all stakeholders. This has been mentioned at the past 20+ CFSAC meetings. That's the real "Good Grief".
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
I'd like to think that they are looking at this from the angle that these alternative treatments need to be put to the test in order to show that they fail - but that's not really how it reads is it. I'm still bemused by homeopathy in general, my wife's GP offered her it the other day. o_O

Coming from a body of scientists, it should really make no sense to test homoeopathy on every disease under the sun to see if it works.

This really does look like a committee document, with no-one having the authority to say, 'no, we're just not putting that bit in.'
 

Bob

Senior Member
Messages
16,455
Location
England (south coast)
The ME Experts letter states what is needed as a foundation for diagnosis and research now, not in 30 years time.
This document seems to have achieved, a good 'foundation', in my opinion. It explicitly states that ME/CFS is not a psychiatric illness, but it is a biomedical illness for which a huge investment in biomedical research is needed. It states what sort of biomedical research is needed. It emphasises post-exertional malaise and cognitive deficits as being consistent features. It de-emphasises 'fatigue' as a feature of the illness. It states that a new single set of consensus criteria are needed to define the illness. It highlights "reproducible" biological measurables, such as "neurocognitive dysfunction" and abnormalities in brain scans. It indicates that CBT does not treat the illness or lead to recovery. And it states that there is strong evidence for an immunological pathology, along with metabolic or mitochondrial abnormalities, that are "potentially important for defining and treating ME/CFS". It seems like a good foundation to me.

e.g. "There is reproducible evidence of neurocognitive dysfunction with abnormalities in functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) studies. Strong evidence indicates immunologic and inflammatory pathologies, neurotransmitter signaling disruption, microbiome perturbation, and metabolic or mitochondrial abnormalities in ME/CFS, potentially important for defining and treating ME/CFS."
 
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Bob

Senior Member
Messages
16,455
Location
England (south coast)
50 experts in the disease seem to disagree with you. HERE. Yes, it is not perfect, but it is certainly better than the Fukuda. There is always room for improvement and refinement, but the experts have spoken and have chosen to adopt the CCC now.
...
To ignore this, is to ignore our experts.
With all due respect, Nielk, this is simply an appeal to authority. Experts are fine, as long as they agree with you. When they don't agree with you, then they're not fine.
 

Ecoclimber

Senior Member
Messages
1,011
I don't appreciated your condescending tone here. some of us might be more cognitively challenged than others. .

@Neilk, you misinterpreted what I meant. I was agreeing with you on the fact of what you said this is why I quoted you as you mentioned something important that others were not picking up! I should have reworded it better
We just need larger scale studies to prove it. The same goes for treatments. Rituximab and Ampligen might be treatments, we just need larger scale studies to prove it.

This is what this report is stating as well and I was highlighting that information. The breath and depth of past clinical research trials failed to take into consideration the points enumerated in this report.

Everyone has their preconceive bias and prejudices, myself included. We all look through rose color tinted glasses only seeing what we want to see. As I mentioned before in my previous postings, NIH actions will need to speak louder than their words. I wanted the NIH to accept the recommendations in the letter of by our ME/CFS researcher but they didn't so we have to deal with the cards that have been dealt to us.

I am skeptical that the NIH will carry out the mandate to the satisfaction of the ME/CFS patient community but let us communicate the areas that we affirm in this document and the areas that we disagree.

Let's not make the mistake and go all negative against the NIH. Thank them for listening and affirming on how we have been treated, removing the stigma of a psychiatric disease and accepting possible biomarkers investigation in their report. The door has been open, let's help them walk through it.
 
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Bob

Senior Member
Messages
16,455
Location
England (south coast)
...singling out Oxford for exclusion, it is understood that Fukuda is meant to stay in.
I don't agree with that. They say nothing about Fukuda specifically, but they say that the current situation (re diagnostic criteria) is unacceptable, as per the following quotes. They specifically state that the current case definitions (i.e. Fukuda and others) are not universally accepted. And they strongly recommend that the current definitions (including Fukuda) need to be replaced with a new consensus criteria. So they do not support Fukuda, but advocate for it to be replaced via a consensual process involving patients and other stakeholders:

"The lack of a universally accepted case definition for ME/CFS has led to difficulty in determining its prevalence and incidence, and has contributed to variability in the estimates reported."

"The lack of a consistent, specific, sensitive diagnostic test and set of criteria has hampered all downstream research on pathogenesis and treatment, causing harm and preventing ME/CFS from being considered as a distinct pathologic entity."

"A clear case definition with validated diagnostic tools is required before studies can be conducted. We noted a consistent constellation of symptoms: fatigue, post-exertional malaise, neurocognitive deficit, and pain."

"The subjective nature of ME/CFS, associated stigma, and the lack of a standard case definition has stifled progress."

"To accelerate the progress of ME/CFS treatment, we recommend the following overarching research strategies: 1. Define disease parameters. Assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach consensus on the definition and parameters of ME/CFS. A national and international research network should be 204 developed to clarify the case definition and to advance the field."
 
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Messages
44
Location
USA
Mary Dimmock has left a comment on Jennie Spotila's blog post that expresses some of the issues that I'm concerned with in a much more eloquent manner than my fog-addled brain can manage. Mary says,

"Thank you for this, Jennie.

I agree with you. You could drive a truck through the loopholes in this report.

My most fundamental concern is the continued lack of clarity on the disease to which this report applies. The report does not state that hallmark criteria like PEM must be mandatory, only that PEM should be studied further. The report recommends against Oxford but says nothing of Fukuda’s failure to require hallmark criteria or its lack of specificity as Nacul and Jason discussed in their presentations.

So what disease does this report refer to? The disease described by the CCC and the ME-ICC? Or the 163 possible different combinations of Fukuda symptoms that Dr. Nacul spoke to – of which only a small portion required PEM.

As written, this report could be read to apply to ME. Or it could be read to apply to the broader scope of disparate conditions encompassed by Fukuda. That lack of clarity on the scope of this disease is the root cause of the lack of progress and needs to be addressed. Implementing this report without doing so is wasteful and worse, is bad science.

The other big issue is the failure to explicitly call for NIH to increase the level of funding to be commensurate with the burden of disease. The report’s funding recommendations were process oriented and/or focused on encouraging public-private collaborations or getting industry involved. But those mechanisms are not enough to overcome NIH’s failure to provide an adequate level of direct funding for basic research, funding that is the engine of both public-private collaborations and industry investment. And those recommendations are not enough to overcome the unique issues ME faces because none of the NIH institutes have stepped up to declare a strategic interest in this disease."

NOTE: If copying and pasting a quote from someone else in this manner without their permission is not allowed, please let me know and I'll remove it.
 

Nielk

Senior Member
Messages
6,970
"To accelerate the progress of ME/CFS treatment, we recommend the following overarching research strategies: 1. Define disease parameters. Assemble a team of stakeholders (e.g., patients, clinicians, researchers, federal agencies) to reach consensus on the definition and parameters of ME/CFS. A national and international research network should be 204 developed to clarify the case definition and to advance the field."
CFSAC recomendation of October 2012 stated:

CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.

We could have saved a million dollars.
 

user9876

Senior Member
Messages
4,556
I think this is an important section to challenge, because we know that depression scales often inappropriately conflate ME symptoms with depressive symptoms, and therefore the depression scales can massively misrepresent the illness.

@Valentijn, do you know anything about this depression scale? And do you know if there any evidence that demonstrates that depression scales are inappropriate for ME patients? (I can't remember.)
There was a spanish research group that looked at HADS for fibromyalga and found it inappropriate.
 

snowathlete

Senior Member
Messages
5,374
Location
UK
It would not necesarily be a good thing if they said Fukuda should be dropped along with Oxford. Perhaps people haven't thought it through. If they had done that it would reduce the signficant impact of the statement that they do make in singling out Oxford as being so bad that it needs to be retired; it does not even meet the new minimum standard of Fukuda (though they suggest all current criteria are inadequate). That alone is absolutely critically massive. If they said Fukuda too, then not only would it reduce the impact of the statment but it might jeopordise Oxford actually being retired as some could make the arguement that Fukuda should be saved...and if Fukuda, then why not Oxford too?
Whoever wrote this is very clear headed and understands the strategy of such things. Hopefully Fukuda will be retired by default when a new definition comes out which included more than fatigue, as this report clearly reccomends, but it shoudn't be listed along with Oxford for retirement at this stage, it's not the pragmatic move.

I feel some people are so hurt by the abuse they have suffered that they just want blood, and nothing else will do. But what purpose does this ultimately serve - does it get us where we need to be?

The report plainly states that PEM occurs consistently, along with other symptoms neuroognotive dysfunction and pain (paraphrased from memory) which are elements included in the ICC. If the NIH accepts this (big question mark) then this would go even further than some are calling for; not just CCC but ICC potentially (or something in the middle) - wouldn't this be a MASSIVE step forward?

I share the concern that many have that NIH will ignore this document or pay lip service to it, or pick and choose bits from it. But the document isn't bad; it's really not crumbs as someone suggested earlier in the thread, it's at least half a baguette.
 
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