The P2P Draft report is out

[Sasha]

BTW, I think there are some great things in this report but also some big omissions, as well as this stuff that's frankly weird.

I think our job now is to praise what we like but push for what changes we want.

 

[A.B.]

I think the homeopathy, mind-body, multimodal stuff looks like special pleading from someone. I'm just amazed that that stuff is in the same report that has metabolomics in it. It's as if a court jester from the Middle Ages walked into a genetics lab.

"Everybody has won and all must have prizes."

 

[RustyJ]

There is one mention of it, Nielk:

"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."

The problem here is that they didn't reference any studies already undertaken to follow up on. Or not many. What is the basis for their statement? Previous work? If they think the work is merited why didn't they pay it some cognizance.

Is this Klimas' area. Well it doesn't surprised me. I've no doubt that this report will pave the way for more work for those who have been good to the government. I just get the impression Klimas' work is never ending, a bit like work on the Lipkin biome. They appear to be looking for the theory of everything, and not being specific enough. In comparison, IIMEs biome project is very specific, and well underway.

We are so far from understanding the complexities of these areas that it could take 50 years or more to make the smallest progress. They are not focussed enough. Didn't godforbid Mikovits come up with a good tie in with a clear subset of ME and cytokine dysfunction which appears to have been ignored? Why not pick up from where she left off?

 

[Nielk]

There is one mention of it, Nielk:

"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."

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.

 

[beaker]

Occupy CFS : Jennie Spotila speaks about report on her blog

I am in the “bah, humbug” minority, though. While there are strong recommendations in the report, many things that I considered essential for success are missing.

ETA @Denise beat me too it and already posted the link. But I will leave this up for the quote.

 

[Wildcat]

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@Sasha wrote:
"I think the homeopathy, mind-body, multimodal stuff looks like special pleading from someone. I'm just amazed that that stuff is in the same report that has metabolomics in it...."


If that stays in the Report it willl provide an excuse for funding for homeopathy and multimodal 'therapy for CFS'. Mindbody researchers and therapy businesses will seize on it to justify more mindbody research. There never seems to be a lack of funding for 'CBT and CFS' studies. We dont want multimodal therapy competing for research funds too.

.
We will never see the end of it.
.

 

[RustyJ]

re critieria: I agree with Bob that some advocates get too caught up with pushing for the ICC.

I don't think that any of the available criteria are great, and that much depends upon how they are used.

The use of a really wide criteria like Oxford is sensible so long as it is only used for research focussed on looking for sub-groups and different useful criteria within that larger group. It is the way Oxford has been used over the last two decades that has been so harmful and misguided, and I think that this has led to some patients thinking that something like ICC must be a great improvement, when really there's a danger to jumping to a criteria like that and assuming that this is identifying patients who all suffer from the same problem.

There is merit in this argument, however I think the years of abuse has forced patients into this position. I agree that ICC will leave out some patients. But what is worse, having all patient cohorts maligned for 30 years or having at least one large cohort clearly defined. Surely it would be relatively easy to work back from that position once the initial cohort has been classified.

Obviously, the better classified the cohort, the better chance of finding a cause. We can then look for that agent in those the missed out on the classification.

Secondly, from a public response point of view, a clear classification of even a subset would boost support financially and emotionally to most patients.

 

[jimells]

The good stuff they left out is as long as my two arms together. For this reason alone this report should be condemned. If they had paid the slightest cognizance to any of the brain studies, even going back to the Kolnick (sp) stuff, the Light work, even some of the cytokine studies which replicated each other, then there might have been some redemption for this report. But they found way to dismiss it all, yet not dismiss PACE.

The entire process of hiring one group to assemble evidence that an entirely separate group is then required to use to make recommendations is a process only a bureaucracy could invent.

The report writers can always claim, "Well we were only allowed to use the evidence they gave us" to rationalize all the research they ignored. But this rationale doesn't hold water, since they were also allowed to develop and use evidence presented at the workshop, which theoretically could have (and did?) include the research excluded previously. If they are allowed to include workshop evidence, then of course they are also allowed to exclude workshop evidence, since obviously they couldn't include every word spoken at the workshop. So if they are allowed to exclude evidence, isn't it logical that they could also exclude research evidence, such as the obviously flawed PACE trial?

(whew. Don't know if any of that makes sense.)

 

[RustyJ]

The entire process of hiring one group to assemble evidence that an entirely separate group is then required to use to make recommendations is a process only a bureaucracy could invent.

The report writers can always claim, "Well we were only allowed to use the evidence they gave us" to rationalize all the research they ignored. But this rationale doesn't hold water, since they were also allowed to develop and use evidence presented at the workshop, which theoretically could have (and did?) include the research excluded previously. If they are allowed to include workshop evidence, then of course they are also allowed to exclude workshop evidence, since obviously they couldn't include every word spoken at the workshop. So if they are allowed to exclude evidence, isn't it logical that they could also exclude research evidence, such as the obviously flawed PACE trial?

(whew. Don't know if any of that makes sense.)

It makes sense alright. Its called plausible deniability. Another bureaucracy 101 tactic. No oversight on the selection of studies either. Accusation that the cut offs were manipulated to rule out studies. Probably missed a few other tricks they would have used.

 

[Nielk]

re critieria: I agree with Bob that some advocates get too caught up with pushing for the ICC.

I don't think that any of the available criteria are great, and that much depends upon how they are used.

The use of a really wide criteria like Oxford is sensible so long as it is only used for research focussed on looking for sub-groups and different useful criteria within that larger group. It is the way Oxford has been used over the last two decades that has been so harmful and misguided, and I think that this has led to some patients thinking that something like ICC must be a great improvement, when really there's a danger to jumping to a criteria like that and assuming that this is identifying patients who all suffer from the same problem.

I don't think that any disease gets defined by patients or advocates. It is the experts in the field who designate criteria for diseases. The following experts in ME/CFS have signed a letter stating that they are adopting the CCC now.

https://snt148.mail.live.com/ol/#

United States Signatories

Dharam V. Ablashi, DVN, MS, Dip Bact.
David S. Bell, MD, FAAP
Gordon Broderick, PhD
Paul R. Cheney, MD, PhD
John K.S. Chia, MD
Lily Chu, MD, MSHS
Todd E. Davenport, PT, DPT, OCS
Kenny L. De Meirleir, MD, PhD
Derek Enlander, MD, MRCS, LRCP
Mary Ann Fletcher, PhD
Kenneth J. Friedman, PhD
Ronald Glaser, PhD, FABMR
Maureen Hanson, PhD
Leonard A. Jason, PhD
Betsy Keller, PhD, FACSM
Nancy Klimas, MD
Konstance Knox, PhD
Gudrun Lange, PhD
A. Martin Lerner, MD, MACP
Susan Levine, MD
Alan R. Light, PhD
Kathleen C. Light, PhD
Peter G. Medveczky, MD
Judy A. Mikovits, PhD
Jose G. Montoya, MD, FACP, FIDSA
James M. Oleske, MD, MPH
James M. Oleske, MD, MPH
Martin L. Pall, PhD
Daniel Peterson, MD
Richard Podell, MD, MPH
Irma Rey, MD
Malcolm S. Schwartz, DO, FAOCP
Christopher R. Snell, PhD
Connie Sol, MS, PhDc
Staci Stevens, MA
Julian M. Stewart, MD, PhD
Rosemary A. Underhill, MB BS, MRCOG, FRCSE
J. Mark VanNess, PhD
Marshall V. Williams, PhD

International Signatories

Alison C. Bested, MD, FRCPC
Nicoletta Carlo-Stella, MD, PhD
Birgitta Evengard, MD, PhD
Øystein Fluge, MD, PhD
Malcolm Hooper, PhD, BPharm, MRIC, CChem
Sonya Marshall-Gradisnik, PhD
Olav Mella, MD, PhD (Added 10/25/2013)
Kunihisa Miwa, MD, PhD (Added 10/25/2013)
Charles Shepherd, MB BS
Nigel Speight, MA, MB, BChir, FRCP, FRCPCH, DCH
Eleanor Stein, MD, FRCP(C)
Rosamund Vallings, MNZM, MB BS

 

[jimells]

The problem here is that they didn't reference any studies already undertaken to follow up on. Or not many. What is the basis for their statement?

To me this is a serious flaw throughout the report. Not a single reference or footnote. Aren't these folks supposed to be scientists? What evidence did they find persuasive? What evidence supports their conclusions? If this were an abstract to a research study, we'd all be screaming, "WHERE'S THE DATA??"

 

[RustyJ]

It makes sense alright. Its called plausible deniability. Another bureaucracy 101 tactic. No oversight on the selection of studies either. Accusation that the cut offs were manipulated to rule out studies. Probably missed a few other tricks they would have used.

The irony is that someone or someones had to have a very good knowledge of the field to even begin to put together studies for review. In all liklihood these people came out of the current crop of researchers and advocates. They are probably held in high esteem by a lot of patients. I wouldn't be too happy about it if I found out the people I had been putting my hopes in for the last 20 years had manipulated data either for their own agenda or for a government agenda.

One of the possible outcomes of this work is that new research contracts will be awarded. Some of the patient organizations who have been most supportive of P2P will be the beneficiaries here, because they have researchers and projects in their stable. So you can see that conflicts of interest can arise.

 

[jimells]

They appear to be looking for the theory of everything

Well they can stop looking. We already know that the answer to everything is "42", as revealed by "A Hitchhiker's Guide to the Galaxy".

 

[Sing]

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@Sasha wrote:
"I think the homeopathy, mind-body, multimodal stuff looks like special pleading from someone. I'm just amazed that that stuff is in the same report that has metabolomics in it...."


If that stays in the Report it willl provide an excuse for funding for homeopathy and multimodal 'therapy for CFS'. Mindbody researchers and therapy businesses will seize on it to justify more mindbody research. There never seems to be a lack of funding for 'CBT and CFS' studies. We dont want multimodal therapy competing for research funds too.

.
We will never see the end of it.
.

On Day 2, Dr. Nelson reviewed the evidence from complementary and alternative research and came up with zero so far, so what basis do even they have for suggesting that such studies should be competing for research money?

On Day 1, Dr. Lenny Jason was the one, if I recall accurately, who spoke of the estimated national cost of ME/CFS, so listening to his segment again ought to bring up the most expert cost estimate.

If we can refer to the statements of their own presenters at the P2P workshop, it seems to me that our suggestions for improving the report will have more influence.

 

[usedtobeperkytina]

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"

And there are others. And some of these failings are in ICC also. I have thought there should "types" of our disease, like there is in hepatitis, MS and diabetes.

While this report does not say what criteria should be used, it does emphasize, almost come out and say, that any good criteria would require neurocognitive problems and pain along with fatigue. This is likely why they didn't endorse Fukuda.

One reason they cannot endorse CCC and ICC is because they are consensus and not validated. As the AHRQ report said, none of these have been tested on a mixed patient population to see if it can distinguish folks with our disease from those with other diseases. The latest revision of ACR fibromyalgia criteria was tested in a study on patients to see if it is specific and sensitive enough to be effective.

What we think is good and makes sense does not mean it has been proven scientifically. They must give opinions here, but they must not go so far in conclusions that it's dismissed as not credible.

I see some evidence in this report of knowledge of the disease beyond what was presented in AHRQ report and what was said in workshop. I suspect they did some of their own research or know someone or came across it in clinical practice.

And I'm sorry if this offends, but I think the fact they are all women brought a different perspective. Women tend to be more collaborative. Women have at some point had a man in authority dismiss their voice because it is higher pitched. I think the emphasis on including patients in planning research comes from that experience and perspective.

 

[worldbackwards]

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@worldbackwards wrote: "... If this document had come out of the UK, we'd be jumping for joy over here."
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Speak for yourself, worldbackwards. I don't personally know anyone in the UK who is joyous about this P2P document. We have accurately read between the lines of so many official Inquiries and Reports over the years/decades.
.

Would you prefer the open contempt of this document, perhaps? It does seem to me that people seem to expect perfection straight away, rather than what is more likely to happen, which is a lengthy eroding of influence. Was CMRC up to much? It remains to be seen. But this seems far more unequivocal, not perfectly so, but more than enough to have the psychiatrists spitting here. I doubt I'll ever live to see something like

Although psychological repercussions (e.g., depression) often follow ME/CFS, this is not a psychological disease in etiology.

or see research like this

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.

given any sort of credence over here whatsoever.

Overturning a scientific consensus is always a slow process, however ridiculous it is and however long you have waited to get your foot in the door. I genuinely think that we really do have our foot in the door. I can't say I ever thought we'd even get that far.

 

[Valentijn]

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.)

It does look like one intended for physically healthy patients. Full text of the questionnaire is at http://cesd-r.com/ or in nicer format at www.valueoptions.com/providers/Education_Center/Provider_Tools/Depression_Screening.pdf

There are 20 questions. Some are pretty direct in asking about people's mental state, but there's also a lot of crap that is purely physical and cognitive:

I was bothered by things that usually don't bother me.
My appetite was poor.
I had trouble keeping my mind on what I was doing.
I felt that everything I did was an effort.
My sleep was restless.
I talked less than usual.
I could not get going.

There's also several questions I don't much like in the context of a debilitating, stigmatized, and incurable chronic illness:

I felt hopeful about the future.
I felt fearful.
I felt lonely.
People were unfriendly.

I think there's some general research about inappropriate questionnaires being used in physically ill populations. I don't recall if any were specifically about ME/CFS.

 

[Wildcat]

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@worldbackwards wrote: "It does seem to me that people seem to expect perfection straight away, rather than what is more likely to happen, which is a lengthy eroding of influence."

~~~~~~~~~~~~~


Sure is lengthy. Its nearly 60 years since the Royal Free Disease outbreak, 1955. Nearly 30 years since Incline Village and the subsequent 'CFS' definitions that disappeared ME and engendered research on vague fatigue constructs that do not define anything in particular.

We are not impatient children. We deserve much better than the P2P Report at this stage.

The ME Experts letter states what is needed as a foundation for diagnosis and research now, not in 30 years time, by which time some of us will be dead. Can't say that I look forward to "a lengthy eroding of influence". I want to see ME researched and treated as the serious biomedical disease it is within my lifetime. Too many lives wasting away, young and old, too many years/decades of rubbish policies.
.

.

 

[Sing]

Regarding questionnaires and inquiries about depression--or anxiety, fear and the other "bad" feelings--I personally have always avoided these as moves in the attempt or direction of delegitimization of a physical illness which needs to be diagnosed and treated as such first, and believe it is essential for us collectively to do so.

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?

Anyway, we are still alive and will take the opportunity we have to communicate to those with the means to select and fund research projects. I also want to highlight the need for greater funding for specialized centers for research and clinical care devoted to our particular illness.

 

[Jonathan Edwards]

Line 281: "Studies investigating homeopathy [...] are needed."

What the...

I have been slow off the mark, not realising the political significance of 'P2P'. This is clearly important for me to understand but I am still on a steep curve... I am hoping that I can read posts faster than they come in. But in order to gather some thoughts before I lose them I will take Sasha's post as a convenient return to earth.

The main reason why us doctors don't get it and don't solve the problem is not personal political agendas (with a few notable exceptions - I will come back to that) it is that like the rest of the human race we are a bit dumb at times. As I have said before, solving this illness is a bit like Bobby Fisher playing Deep Blue, except in this case Bobby Fisher is indisposed so the high school chess champion will have to do for now. I think Ecoclimber made a lot of good points. Cock up is more common than conspiracy and there is actually some indication, at least to my antennae, that this report (which I have not seen yet) has had some input from people who can do better than that. OK, Alex is right about the cheese sandwich, and it has some tomato in it that has gone a bit soggy, but there are other venues for addressing that. A committee camel is a committee camel. I think Bob is right that this is as good a camel as you can expect. And I think there are some signs of sense here. (Along with, as Sasha indicates, maybe some signs of something else.)

You thought that was a sell out to the establishment? But let's play the other game. What do egos do? They neutralise other egos. So, as those who have studied the history of the Holy Roman Empire and the final emergence of German and Italian States or 'I, Claudius', or 'Richard III' or some political footwork in the Near East more uncomfortably close to our time (i.e. 2014), the big mistake in politics is to think you know who is on your side - and maybe more so to think you know who is not on your side. Do I perceive a little trans-Atlantic feeling marginalised here? The financial interests work differently across the pond. Are some cracks appearing? The green eyed God is never far away. I had better read the report.