The P2P Draft report is out

Bob

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I wrote a really long dissection of the report but it's on the other thread. How can I move it here?

http://forums.phoenixrising.me/inde...es-the-p2p-report-come-out.34217/#post-536444
Click on 'edit' at the bottom of that post; select all your text (so it's all highlighted); then 'copy' it (right-click on any highlighted text, then click on 'copy'), then 'paste' it into this thread (right-click in the text field that you use for writing a new post, then click on 'paste'.) Good luck!
 

Bob

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There are signs that they have listened to input from patients up to this point, so it probably wont be a wasted effort.
Yes, it seems to me that all the hard work that everyone has done with respect to this process has paid off! I think i recognised sections of the text that clearly came from the patient community. Congrats and many thanks to everyone who worked on it. I think you should give yourselves a huge pat on the back, as this report is surprisingly helpful for us, in my opinion.
 

snowathlete

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And so will patients who are prescribed this as "treatment"
Yes, Well put!
The report says something somewhere about patients thinking GET is harmful, but said as if it isn't? That's one bit I will be providing feedback on. I had GET before I knew anything about potential harms and I found out the hard way. If only i had known! it did harm me. Very much. I think if there is any support given for it being used as a treatment on any level, that patients must be warned of the severity and liklihood of negative outcomes.
 

Bob

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I think we should all be sending in our thoughts, in our own words, even if it's a very brief comment. And it's probably a good idea to say "thanks" for the good parts, while objecting to the bad parts :D
Very good points, Val. It's easy to forget to praise things that we approve of, but we need to praise the good sections, in case others (people who are not friends of our community) are desperately attempting to get them removed or watered-down or modified.
 

jimells

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32 ME/CFS exists.
Well Halleluiah!

52 ...and a research focus on men
This is strange, because later on the report complains that studies are mostly female patients:
88 Clinical studies have focused on predominantly Caucasian, middle-aged women.

92 Although psychological repercussions (e.g., depression) often follow ME/CFS, this is not a psychological disease in etiology.
Note the careful use of the word "etiology". This fits in with Sir Weasel's theory of a biological etiology that is continued by the insistence of the patient to think the wrong thoughts. This is left unspoken in the above quote.


99 Future studies should distinguish between ME/CFS alone, ME/CFS with comorbidities, and other 100 diseases
What about distinguishing between ME and CFS! So far, this document completely ignores this issue and the entire history of the naming debacle. We don't know if the authors think "ME/CFS" is one illness with a funny compound name, two illnesses somehow jammed together, or something else. Really, we have no idea what exact illness this report is even talking about!


105 A clear case definition with validated diagnostic tools is required before studies can be conducted.
Is this a statement of the obvious or an excuse not to fund any more research?


113 Existing treatment studies (cognitive behavioral therapy [CBT] and graded exercise therapy [GET]) demonstrate measurable improvement, but this has not translated to improvements in quality of life (QOL). Thus, they are not a primary treatment strategy and should be used as a component of multimodal therapy.
Looks like they're trying to thread the needle here. They didn't study the PACE garbage very close, or have chosen to ignore its obvious flaws. It's hard to understand how any sincere person could think that the claimed study improvements should trump actual real-world experiences that contradict study results, especially after admitting that contradiction.


135 In many cases, lack of instructions or guidance for including graded exercise therapy often causes additional suffering, creating fear of harm from a comprehensive self-management program that may include some physical activity
So GET creates a "fear of harm" but no actual harm? This is really, really bad. It implies that GET would work if only it were properly implemented.


159 Patient- centered tools that use simple statements need to be developed to ensure that the patients understand the questions.
I fail to see how better subjective questionnaires will move the science forward, although maybe they can sort-of help clinicians make a diagnosis? But if a clinician needs to use a questionnaire to make a diagnosis, are they really qualified to diagnosis this illness?


191 The dissemination of diagnostic and therapeutic recommendations should focus on primary care providers.
Nope. Nada. NO. GPs have no business managing this illness on their own. No one would expect a GP to manage any other severe, complicated multi-systemic disease. Patients will never receive proper diagnosis and treatment until there are competent specialists accessible to everyone with this illness.


198 Findings in the literature are inconsistent, and there are many gaps (e.g., Is ME/CFS one disease?).
Well, how did this little tidbit get slipped in past the psychobabblers? But still, how about, "Is ME CFS?"


At Line 200 the report moves into recommendations. They are so obvious, I hope they didn't have to strain to hard to come up with them.

213 Create new knowledge. Investing in bench-to-bedside to policy research for ME/CFS is recommended
Huh. "Create new knowledge" and do some research. Why didn't I think of that. Looks like whoever paid for their fancy degrees got their money's worth.


244 Researchers should be encouraged to develop a repository for qualitative and quantitative work. Similar to cancer registries, there is much to learn by developing a registry/repository of all patients with ME/CFS
This has already been rejected by HHS. The report writers probably don't know that.


282 Studies addressing biopsychosocial parameters (including the mind-body connection), function, and QOL should be encouraged.
A grab-bag of recommendations naturally has to include something for everyone, especially the psychobabblers.


313 We believe ME/CFS is a distinct disease that requires a multidisciplinary care team (e.g., physicians, nurses, case managers, social workers, psychologists) to optimize care.
But no neurologists/endocrinologists/immunologists to treat patients with a neuro/endo/immuno illness? REALLY?


362 The modest benefit from CBT should be studied as adjunct to other modalities of treatment such as self-management..
Never miss a chance to promote psychobabble!


365 We recommend that the NIH and the FDA convene a meeting on the state of ME/CFS treatment.
Yup. Let's have a meeting to discuss if we should have more meetings


379 Thus, for needed progress to occur we recommend (1) that the Oxford definition be retired, (2) that the ME/CFS community agree on a single case definition (even if it is not perfect), and (3) that patients, clinicians, and researchers agree on a definition for meaningful recovery..
Finally, something specific, helpful, and doable. Thank you. The "community" (excepting psycobabblers, of course) already seems to agree on the CCC. Too bad the report doesn't mention that and recommend the CCC for adoption. But I don't imagine that would be allowed.


384 We believe there is a specific role for multimodal therapy.
Anybody know what this is? Smells like CBT and GET to me.


Well that's it. No footnotes. No references. No data. The Evidence Review was not included by reference. I guess that's what makes it "Executive" material!

p.s., the line numbers are part of the original document.
 

Bob

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Note the careful use of the word "etiology". This fits in with Sir Weasel's theory of a biological etiology that is continued by the insistence of the patient to think the wrong thoughts. This is left unspoken in the above quote.
But they also explicitly say this:
"296 ...ME/CFS is not a psychiatric disease..."

What about distinguishing between ME and CFS! So far, this document completely ignores this issue and the entire history of the naming debacle. We don't know if the authors think "ME/CFS" is one illness with a funny compound name, two illnesses somehow jammed together, or something else. Really, we have no idea what exact illness this report is even talking about!
I think they have ever-so-slightly touched on this issue, by specifying that Oxford (chronic fatigue) does not define ME or CFS.
And I think they've gone some way towards indicating that any new criteria should properly define an illness that we would recognise as 'ME':
"We noted a consistent constellation of symptoms: fatigue, post-exertional malaise, neurocognitive deficit, and pain."

Yes, they haven't explicitly defined ME, ME/CFS or CFS, but they have suggested that there should be a separate (consensual) process to define the illness/es.
 

Sean

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Just finished reading through it, and I really don't think there is much comfort to be had from it for the Wesselys, Whites, and Chalders of the world, whereas there is a lot of comfort and hope in it for patients (and their supporters in the clinical, research, and general communities).

I was very apprehensive about what this report would say, an awful lot of our future lay in its hands, but I have no serious problems with it. Quite the contrary, I feel quite relieved and pleased at the real possibilities it offers. It firmly nails to the door a lot of the problems we have been trying to raise for decades, and opens a few serious doors.

Is it perfect? No. But it doesn't have to be, indeed it couldn't possibly be. Don't let the perfect be the enemy of the good. Patients must be prepared to change with the circumstances, and they just improved for us a whole lot with this report.

Certainly point out any real and significant problems or deficiencies with it. And just how much it all translates into real value on the ground remains to be seen. But at this point I don't think we could have reasonably expected much better, and we should work with it, not against it.
 

catly

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Let's not forget that the IOM report to "re-define" the illness will be out in the next few months. I'm not sure we will have the ability to comment on that- so perhaps it would be helpful to make that point in commenting on the P2P report, especially given their emphasis on involving patients.
 

jimells

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Overall, I see a carefully-crafted political document that can, to a large extent, be interpreted to mean whatever the reader hopes to see. I'm sure the psychobabblers will be able to twist this report to suit their purposes. Of course, they could do that with pretty much any document about this illness.

At first blush I thought that this report is not good for the insurance industry that wants to deny all testing and treatment other than CBT/GET, what with all the biochemical anomalies they mention. But the insurance industry can simply point to all the uncertainty to justify their position.
 

Esther12

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Maybe my hopes were raised by positive comments here, and I've not finished reading through yet, but so far I'm tending to agree with @jimells assessment most.

This isn't the purely terrible report we feared, but a lot of it is vague and could be interpreted in worrying ways, and a lot of the things people are happy about being acknowledged (myself included) don't really lead on to much. It does seem like they've not just dismissed all patient's concerns, but there are quite a few things to still be concerned about, and I don't think we should get distracted by the change in tone, welcome as it may be.

Just finished reading through it, and I really don't think there is much comfort to be had from it for the Wesselys, Whites, and Chalders of the world, whereas there is a lot of comfort and hope in it for patients (and their supporters in the clinical, research, and general communities).
I don't think there much (anything other than dumping Oxford criteria?) in there that the Wesselys, Whites and Chalders wouldn't be able to agree with - even if they might had to twist some language a bit (and we know they're happy to do that).

Overall, I see a carefully-crafted political document that can, to a large extent, be interpreted to mean whatever the reader hopes to see.
I'm not sure how cynical that was though - it could be that they left much vague because there's so little good evidence to guide them. It took me more than a couple of years arguing things out with people to really get my head around my own views on ME/CFS... and that was after I'd been ill for nearly a decade. The people who wrote this had a week.
 

Large Donner

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I like loads of it, but these are some items that particularly stuck out...

this is not a
93 psychological disease in etiology.

38 The Oxford criteria (published in the Journal of the Royal
39 Society of Medicine in February 1991) are flawed and include people with other conditions,
40 confounding the ability to interpret the science.

378 Specifically, continuing to use the Oxford definition may impair progress and cause
379 harm. Thus, for needed progress to occur we recommend (1) that the Oxford definition be
380 retired,

Now we know what the Simon Wessely pre-emptive strike in the Independent was all about. Finally after years of claiming to retire from ME and making countless comebacks, a whole medical panel has recommended Wessely retires once and for all. Somebody needs to tweet that to Wessely and the Journalist and see if how they spin that in "patient Lobby attacking".

(2) that the ME/CFS community agree on a single case definition (even if it is not
381 perfect), and (3) that patients, clinicians, and researchers agree on a definition for meaningful
382 recovery.
Retract the PACE trial as it used Oxford criteria. In Peter Whites own words it wasn't a study on "CFS/ME" but on "the operational definition of fatigue". This is clearly aimed at the pace trial defintion of recovery. Another kick in the balls to Wessley and White the two main leads in the PACE trial although many don't realise Wessely had a formal overseeing position in it.​

82 There is reproducible evidence of neurocognitive dysfunction with abnormalities in functional
83 magnetic resonance imaging (fMRI) and positron emission tomography (PET) studies. Strong
84 evidence indicates immunologic and inflammatory pathologies, neurotransmitter signaling
85 disruption, microbiome perturbation, and metabolic or mitochondrial abnormalities in ME/CFS,
86 potentially important for defining and treating ME/CFS.
Me thinks its time for more comments on the Independent article which I will now be referring to as "the P2P calling for Wesselys final retirement section".

How about a mass tweeting of "Wessely = Oxford defintion"
 
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Sean

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Overall, I see a carefully-crafted political document
It certainly has a political side to it, which is both unavoidable at that level, and not necessarily a bad thing.

These kind of reports are also typically as much about managing the politics of serious change, as making the change it self. That is just an unpleasant necessity of power games.

that can, to a large extent, be interpreted to mean whatever the reader hopes to see.

[And taking into account what Esther said about the very limited time the report authors had to wrap their heads around all this stuff.]
I struggle to see how you can come to that conclusion.

Just retiring the Oxford criteria is a big step forward on its own, not just for future studies, but it clearly implies that any existing studies using it are suspect. Take Oxford based studies out of the picture (e.g PACE), and it is a very different picture. This a big public slap in the face of the promoters and users of the Oxford criteria.

But maybe I am just so desperate after 30 years of waiting that I will cling onto anything. We shall see.

I certainly have no doubt that the Wesselys, Whites, and Chalders of the world will try to spin it all in their favour, including some shameless historical revisionism.
 

Sing

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While positive and sympathetic, this draft document reads as if it were indeed written hastily by a committee. It has "everything but the kitchen sink" in it (old American expression). It is up to us to contribute our knowledge to help them edit and shape this up into clearer, more specific recommendations.

I wish that since they do see that this is not a psychiatric illness, they wouldn't keep refering to it. Repeating that it has overlapping features with Depression and Fibromyalgia, and also that drugs used to treat Fibromyalgia ought to be tested on us, are examples of ideas which take us back into the past to go over ground which has already been covered. Similarly, to recomend that alternative treatments ought to be tested has no evidence to support it at all, including their review of complementary and alternative modalities. What would be deadly for us in terms of more wasted money and years is if the research coming out of these recommendations just continues to circle around the old unproven and unhelpful medications and treatments.

We can help sharpen the focus towards more cutting-edge research. I am too tired to be more specific right now but I am going to go back over this document, after reading everyone's comments here in the next few days, and write to them.

One major omission from this document, by the way, is any reference to autonomic dysfuntions, which are rife in me as well as many others with ME.
 

Kati

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Well Halleluiah!



This is strange, because later on the report complains that studies are mostly female patients:





Note the careful use of the word "etiology". This fits in with Sir Weasel's theory of a biological etiology that is continued by the insistence of the patient to think the wrong thoughts. This is left unspoken in the above quote.




What about distinguishing between ME and CFS! So far, this document completely ignores this issue and the entire history of the naming debacle. We don't know if the authors think "ME/CFS" is one illness with a funny compound name, two illnesses somehow jammed together, or something else. Really, we have no idea what exact illness this report is even talking about!




Is this a statement of the obvious or an excuse not to fund any more research?




Looks like they're trying to thread the needle here. They didn't study the PACE garbage very close, or have chosen to ignore its obvious flaws. It's hard to understand how any sincere person could think that the claimed study improvements should trump actual real-world experiences that contradict study results, especially after admitting that contradiction.




So GET creates a "fear of harm" but no actual harm? This is really, really bad. It implies that GET would work if only it were properly implemented.




I fail to see how better subjective questionnaires will move the science forward, although maybe they can sort-of help clinicians make a diagnosis? But if a clinician needs to use a questionnaire to make a diagnosis, are they really qualified to diagnosis this illness?




Nope. Nada. NO. GPs have no business managing this illness on their own. No one would expect a GP to manage any other severe, complicated multi-systemic disease. Patients will never receive proper diagnosis and treatment until there are competent specialists accessible to everyone with this illness.




Well, how did this little tidbit get slipped in past the psychobabblers? But still, how about, "Is ME CFS?"


At Line 200 the report moves into recommendations. They are so obvious, I hope they didn't have to strain to hard to come up with them.



Huh. "Create new knowledge" and do some research. Why didn't I think of that. Looks like whoever paid for their fancy degrees got their money's worth.




This has already been rejected by HHS. The report writers probably don't know that.




A grab-bag of recommendations naturally has to include something for everyone, especially the psychobabblers.




But no neurologists/endocrinologists/immunologists to treat patients with a neuro/endo/immuno illness? REALLY?




Never miss a chance to promote psychobabble!




Yup. Let's have a meeting to discuss if we should have more meetings




Finally, something specific, helpful, and doable. Thank you. The "community" (excepting psycobabblers, of course) already seems to agree on the CCC. Too bad the report doesn't mention that and recommend the CCC for adoption. But I don't imagine that would be allowed.




Anybody know what this is? Smells like CBT and GET to me.


Well that's it. No footnotes. No references. No data. The Evidence Review was not included by reference. I guess that's what makes it "Executive" material!

p.s., the line numbers are part of the original document.

I very much agree with @jimells here. while there may be good parts of this report, the conclusions are vague, and there are wording issues which could lead to different kinds of interpretations. We all know too well about twisting things around.

Moreover, this report makes no recommendation for new money to be allocated to the disease. We all know that what this illness needs is serious funding for serious disease. There seems to be a discrepency about the cost to society, they said 1 billion, when we have heard 8 billions- that is a difference of 7 billions. How is that for downplaying?

The report failed to acknowledge the FDA report which could have helped greatly.

The allusion that patients need education- they still have the false belief that we may still have
  1. 87 Overall, limited patient and professional education has impaired progress in managing ME/CFS
For all we know they could decide to approve Fukuda not CCC "even if it's not perfect".

They mention complimentary medicine and how NIH could help us this way- remember Gary Caplan on the CFSAC??? While many over here see complimentary medicine as the only way to go, my opinion is that this disease needs serious medicine and serious research, coming from infectious disease, genomics, neurology and all of the traditional medicine and rigorous science has to offer. We need real drugs, drug deveopment, not diet management or supplement management. (placebo effect anyone? patients are still sick and none of us are cured by adding one more supplement from iherb)

There are no promises of anything in this report and in fact I would advance that what may come out of it is one puny meeting and nothing more- just burrying some more.

These are just a few of my remarks.

I do not see this report as a victory. It has a lot of opportunities to fail us all over again. Please read and re-read the report and comment accordingly.
 

Kati

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While positive and sympathetic, this draft document reads as if it were indeed written hastily by a committee. It has "everything but the kitchen sink" in it (old American expression). It is up to us to contribute our knowledge to help them edit and shape this up into clearer, more specific recommendations.

I wish that since they do see that this is not a psychiatric illness, they wouldn't keep refering to it. Repeating that it has overlapping features with Depression and Fibromyalgia, and also that drugs used to treat Fibromyalgia ought to be tested on us, are examples of ideas which take us back into the past to go over ground which has already been covered. Similarly, to recomend that alternative treatments ought to be tested has no evidence to support it at all, including their review of complementary and alternative modalities. What would be deadly for us in terms of more wasted money and years is if the research coming out of these recommendations just continues to circle around the old unproven and unhelpful medications and treatments.

We can help sharpen the focus towards more cutting-edge research. I am too tired to be more specific right now but I am going to go back over this document, after reading everyone's comments here in the next few days, and write to them.

One major omission from this document, by the way, is any reference to autonomic dysfuntions, which are rife in me as well as many others with ME.
I agree @Sing with all you said. The allusions to co-morbidities are unhelpful and perhaps also harmful since fibromyalgia and other co-morbidities are also stigmatized, poorly accepted and poorly funded.
 

alex3619

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First impressions, posted by me on Facebook:

We need a proper meal, they offered us a stale cheese sandwich, but after some consideration we can have a pickle with that.

I just skimmed the report. Its rehashing, for the most part, what various advocates have been saying for years. The main exception is that its still too influenced by CBT/GET which has no clear clinical value.

If they had got a team of advocates together, over a nice meal, and had a long chat about long standing issues, we would have heard nearly all of it, and more. Total cost, maybe $500. Of course they would not have then been able to write an official sounding document.

I have blogged in one form or another about most of the scientific needs. The only good thing to come of this, which is definitely not new to advocacy, is that the Oxford definition should not be used and may be harmful.

One thing we should consider though, while still arguing the P2P process is flawed, is to push the notion that large coordinated and funded research collaboratives are needed, to the NIH. Its interesting that one of the studies they recommended was on the microbiome, for which Lipkin has already received a funding rejection.

To summarize:

1. Stating the obvious.
2. Advocates have been arguing these same points for years.
3. It is however an official document that may net us a little extra leverage to get better research funding.