The P2P Draft report is out

[Esther12]

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.

 

[worldbackwards]

I think this may the beginning of a slow ushering out of CBT/GET. I don't buy the idea that anyone's about to turn round and say they were wrong about this at any point - it would be embarrassing and damaging to them. Far more likely that it will be allowed to dwindle into the background as further research makes it obsolete. Given that, I really don't think that we could have expected anything better, and I think everyone expected it to be a lot worse. If this document had come out of the UK, we'd be jumping for joy over here.

 

[Bob]

293 Use of already well-validated measures developed by the NIH such as the
294 Patient-Reported Outcomes Measurement Information System (PROMIS) and
295 the Center for Epidemiological Studies Depression scale (CESD) should be
296 encouraged. Although ME/CFS is not a psychiatric disease, exploring
297 psychiatric comorbidities such as depression, anxiety, and fear is critical to
298 improve quality of life.

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.)

 

[Nielk]

In my opinion, the statement that this is an illness characterized by "fatigue' as opposed to PEM/PENE, is perpetuating the old myth of this disease. This will guarantee that in 25 years from now, we will be in the same hole.

There will be no advancement in the science until an official adoption of this cardinal symptom is accepted. Otherwise, it is stuck as an umbrella "fatiguing" illness, perpetually.

In addition, why was there no mention of the biomarker of low NK cell function?

 

[Roy S]

I have to confess to some initial overly optimistic thoughts from the triumph of low expectations for this whole process. (and with my background there is no excuse for that)

However, there is a big problem simply recommending CBT, at least in the United States. In the real world patients run a risk of getting something else as described in this article:

http://well.blogs.nytimes.com/2013/03/25/looking-for-evidence-that-therapy-works/?_r=1

There is also a very real possibility for psychological harm that may be serious and permanent which is discussed in this previous thread:

http://forums.phoenixrising.me/index.php?threads/psychological-treatments-that-cause-harm.25417/
　
It doesn't appear that any of the NIH ME CFS P2P panel members have knowledge of real world clinical psychology.
　
Kathleen M. O’Neil, Penney Cowan, Carmen R. Green, Ronit Elk, Angela L. Rasmussen

https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/me-cfs/panel-members
　
　
　
　

 

[jimells]

Did we really have to spend close to a million dollars to have an official written report about this.

Wow. I had no idea. A million bucks for 20 pages. That money could've been used for, I dunno, research?

I agree with Nielk that this is a good document for the purpose of co-opting opponents. The document does not stand on its own. It is only one part of a murky process from an agency with very well documented hostility towards the patients.

 

[beaker]

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.)

A long time ago a dr in charlotte took out the questions of a standard psych screen ( I forget which one ) that would have ME/CFS symptoms be labeled as depression. ( e.g. I feel tired all the time ). Used it on cheney's amp patients. I don't think it was ever published though. shame.

 

[RustyJ]

I think this may the beginning of a slow ushering out of CBT/GET. I don't buy the idea that anyone's about to turn round and say they were wrong about this at any point - it would be embarrassing and damaging to them. Far more likely that it will be allowed to dwindle into the background as further research makes it obsolete. Given that, I really don't think that we could have expected anything better, and I think everyone expected it to be a lot worse. If this document had come out of the UK, we'd be jumping for joy over here.

In addition, why was there no mention of the biomarker of low NK cell function?

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.

They have washed 30 years of biomedical research into this illness down the drain in this report. This is a fundamental issue. Was it worth letting all that go?

 

[Wildcat]

.
@worldbackwards wrote: "... If this document had come out of the UK, we'd be jumping for joy over here."
.
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.
.

 

[RustyJ]

Wow. I had no idea. A million bucks for 20 pages. That money could've been used for, I dunno, research?

Good point.

 

[Bob]

Not a suitable reason for not adopting at least one of them. I can guarantee both are considerably better than Fukuda. And if the debate is about a comparison between the three, and the focus on fatigue is the issue, then Fukuda comes a long way last. It is not a big leap from CCC to ICC, but years from Fukuda to CCC. There is no way they are going to shift on this for decades. So ideopathic fatigue will continue to confuse any research for decades.

The document doesn't recommend Fukuda. As @Wildcat says, they side-step the issue of diagnostic criteria. (It was not in its remit to make decisions about diagnostic criteria.) Instead, it recommends that the community create a single, widely-accepted consensus criteria. (You could say this is redundant because we already have the CCC and ICC, but it leaves the door open for a new consensus criteria that would be accepted by the NIH.) In terms of ideopathic fatigue, it moves away from that by dismissing Oxford, for the right reasons, and by emphasising post-exertional malaise as a consistent feature of the illness.

I think it moves the government in the right direction.

The argument that these big scale studies are going to be the be all and end all is fraught also. PACE was such a study, and look at the manipulations and deceptions involved in that one. There is a mind set that the bigger the study, the more it is to be believed.

Sure, just because a study is done on a large-scale, doesn't mean that it is useful. But in terms of biomedical research, large-scale studies is exactly what is needed to try to define the biological differences. e.g. large-scale studies of proteomics, metabolomics, auto-immunity, anti-bodies, cytokines, etc. And that's what the document recommends, explicitly, repeatedly and prominently.

 

[RustyJ]

.
@worldbackwards wrote: "... If this document had come out of the UK, we'd be jumping for joy over here."
.
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.
.

This model of crowd management has been and is being used in the UK. I think the CMRC is the latest iteration. Before that it was the Research Advisory Group for ME/CFS. Everyone holding hands for a better future. Big promises, with little to show. Same people still behind the scenes pulling the strings. That's why I wondered if something along similar lines to the CMRC is being planned here.

 

[Bob]

why was there no mention of the biomarker of low NK cell function?

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."

BTW, I haven't read up on the research in great detail, but as far as my understanding goes, they are accurate to say "NK cell dysfunction" rather than "low NK cell function."

 

[jimells]

Multimodal therapy (MMT) encompasses CBT, along with a whole load of other stuff that we don’t want either….
Funding for MMT research, anyone?

Thank you for this. I had no idea what "multimodal therapy" meant, but I knew it didn't sound good...

the clinician may ask: "What is this individual doing that is getting in the way of his or her happiness or personal fulfillment

"Happiness" and "personal fulfillment" are irrelevant. I'm too exhausted from trying to obtain the necessities of life, like food, shelter, and competent medical treatment.

The whole MMT thing sounds like something for people with money burning a hole in their pocket and therapists collecting the money that falls out.

 

[Bob]

In my opinion, the statement that this is an illness characterized by "fatigue' as opposed to PEM/PENE, is perpetuating the old myth of this disease.

Valid point, but they do recommend research in the area of immune exhaustion:
"These also should be longitudinal studies to explore the possibility of a progressive immune exhaustion or dysfunction in ME/CFS."

 

[Nielk]

As a reminder, this is from the letter of October 2013 to the Secretary oh DHHS signed by 50 experts in ME/CFS.

Dear Secretary Sebelius,

We are writing as biomedical researchers and clinicians with expertise in the disease of Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to inform you that we have reached a
consensus on adopting the 2003 Canadian Consensus Criteria (CCC) as the case definition for
this disease.

The 1994 International Case Definition (Fukuda et al, 1994), commonly known as the Fukuda
definition, was the primary case definition for ME/CFS for almost two decades. However, in
recent years expert researchers and clinicians have increasingly used the CCC, as they have
recognized that the CCC is a more scientifically accurate description of the disease.

The CCC was developed by an international group of researchers and clinicians with significant
expertise in ME research and treatment, and was published in a peer-reviewed journal in 2003
(Carruthers et al, Journal of Chronic Fatigue Syndrome, 2003). Unlike the Fukuda definition, the
more up-to-date CCC incorporates the extensive scientific knowledge gained from decades of
research. For example, the CCC requires the symptom of post-exertional malaise (PEM), which
researchers, clinicians, and patients consider a hallmark of the disease, and which is not a
mandatory symptom under the Fukuda definition. The CCC was endorsed in the Primer for
Clinical Practitioners published by the International Association of Chronic Fatigue Syndrome/
Myalgic Encephalomyelitis (IACFSME). This organization is the major international professional
organization concerned with research and patient care in ME/CFS.

The expert biomedical community will continue to refine and update the case definition as
scientific knowledge advances; for example, this may include consideration of the 2011 ME
International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011). As
leading researchers and clinicians in the field, however, we are in agreement that there is
sufficient evidence and experience to adopt the CCC now for research and clinical purposes,
and that failure to do so will significantly impede research and harm patient care. This step will
facilitate our efforts to define the biomarkers, which will be used to further refine the case
definition in the future.

We strongly urge the Department of Health and Human Services (HHS) to follow our lead by
using the CCC as the sole case definition for ME/CFS in all of the Department’s activities
related to this disease.

In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute
of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for
ME/CFS. Since the expert ME/CFS scientific and medical community has developed and
adopted a case definition for research and clinical purposes, this effort is unnecessary and
would waste scarce taxpayer funds that would be much better directed toward funding research
on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging
non-experts in the development of a case definition for a complex disease about which they are
not knowledgeable.

 

[Denise]

Food for thought on the draft report from Jennie at OccupyCFS:
http://www.occupycfs.com/2014/12/19/p2p-report-first-read/#comment-105412

 

[A.B.]

The recommendation for multimodal therapy seems to be an attempt to continue inflicting stigmatizing useless therapies on patients.

This draft seems is obviously written by different people with different view points. I think we have the psychologist on the panel to thank for this.

 

[Sasha]

Lines 6/7: "...economic burden estimated to be greater than $1 billion."

$17 billion, surely? Just in the US?

Edit: Yes - here's the study:

http://www.dynamic-med.com/content/7/1/6

 

[Sasha]

The recommendation for multimodal therapy seems to be an attempt to continue inflicting stigmatizing useless therapies on patients.

This draft seems is obviously written by different people with different view points. I think we have the psychologist on the panel to thank for this.

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.