The P2P Draft report is out

[Sean]

So it is perfectly reasonable to focus attention on people with PEM but I think calling it PENE is a bit imaginative since we do not know what neuroimmune exhaustion would be.

I have never been comfortable with the PENE label/concept. It might be right but I think it is getting a bit ahead of the evidence at this point, and we are in danger of getting lost in the politico-linguistic forest.

Which doesn't mean there are not important neurological and immune features. Just that I don't think we are at the point where we can make definite statements about the nature of PEM, particularly about the causal relationships involved. Though I think we can certainly say it exists, and that understanding it is critical to understanding the whole disease.

From the International Consensus Primer:

The underlying pathophysiology of PENE involves a profound dysfunction of the regulatory control network
within and between the nervous systems

We don't know if this 'dysfunction' starts within those systems/processes, or if it is just the body's attempt to compensate for something else going wrong further back up the causal chain (e.g. via infection, etc). That is, we don't know enough to be sure about PEM's place in the causal chain.

Trying to treat immune parameters directly, for example, might be a dead end if that is not the cause of immune 'dysfunction' and the immune system is actually okay but is just having to deal with something that is pushing it outside its normal operating parameters.

PEM might be just the body's response to adverse circumstances, in the same kind of way that the sick feeling from the flu is from our otherwise healthy body's reaction to the flu virus, not from the virus itself.

 

[duncan]

If you can measure some of PEMs manifestations, patients and their advocates may be able to use that data to help on several different levels. The Light studies only explored one aspect.

But, eh, time and resources would have to be marshaled to create such metrics.

 

[Esther12]

I can see that there are good reasons for using tighter criteria for recruiting to a trial of GET in particular. However, I am surprised about the enthusiasm for restricting the definition of ME in the practical clinical setting. Are people not worried that a large number of PWME are going to lose their disability benefits? A number of posters on PR seem to think PWME are going to be sold down the river with new tighter criteria on that score.

I started trying to answer that, and it got very complicated. I think it has something to do with i) the history of the Oxford criteria, and also the CDC's loosening of criteria, ii) the way poorly done research (eg some personality stuff) has been used to promote attitudes towards patients which would not be permited for (for eg) gays - if a diagnosis will be used like this then people naturally want to be associated with as few others as possible, and hoefully those with more similar problems, iii) I think that some people can have an exagerated view of how far research has progressed in allowing us to identify a subset of patients who do share the same cause of their health problems.

I think that there's more to it than that, and also all of those points have a lot going on within them.

 

[alex3619]

I get two different reactions - one which I seems to be OI related the other immune (I'm guessing, obviously)

I get several types of reaction, which I consider PEM subsets, depending on what triggers I am exposed to in addition to activity. We need solid biomarker/s to really define PEM.

 

[Valentijn]

Yes, but presumably the Lights studies are not demonstrating an association with all PEMs, just one or some of them.

There's only one typical PEM (and maybe a separate cognitive one). The other, resulting from orthostatic intolerance, is a more typical exercise intolerance. It sounds like most or all people with OI get that one, though sometimes people think it's the same as PEM. But OI exercise intolerance doesn't come with a big delay, doesn't last days or longer, is avoided by exercising while sitting or lying down, and doesn't feel particularly like the flu. However aches, pains, and brain fog do occur with OI exercise intolerance, which seems to be the basis for the confusion.

Psychobabblers also like to pretend that PEM and Delayed-Onset Muscle Soreness (DOMS) are the same thing. DOMS is the soreness and stiffness felt in muscles after pushing their limits a bit. The timing can be the same, but the PEM pain is body-wide, not merely affecting the muscles used, and DOMS doesn't involve painful lymph nodes, extended brain-fog, etc. DOMS also feels quite good somehow, compared to PEM, in my experience.

 

[Sing]

All this discussion is a great work out for the brain. Mine is sprouting new neurons just trying to follow it. But really I am not up to this level of analysis. I agree it is necessary to be as clear as possible about the meaning of words, not to block inquiry and understanding by making unwarranted judgments and coming to premature conclusions, and not to be vague, etc. However,

What I particularly need to read are examples from all of you of responses to the P2P draft summary. I can try to do it myself, but expect that more intelligent, comprehensive comments on various lines or sections could be put together by this group. Suggestions would be most welcome! Of course, they could happen later in this thread after some of the questions above feel better answered.

 

[Scarecrow]

There's only one typical PEM (and maybe a separate cognitive one). The other, resulting from orthostatic intolerance, is a more typical exercise intolerance. It sounds like most or all people with OI get that one, though sometimes people think it's the same as PEM. But OI exercise intolerance doesn't come with a big delay, doesn't last days or longer, is avoided by exercising while sitting or lying down, and doesn't feel particularly like the flu. However aches, pains, and brain fog do occur with OI exercise intolerance, which seems to be the basis for the confusion.

Actually, I agree but it wasn't until about a year ago that I began to understand the difference. That's after 25 years of PEM (and 30 years of ME - i.e. you can have ME without PEM). But even you, as am I, are conflicted about whether the cognitive PEM is different to the 'classic' delayed PEM after exercise. In my experience the cognitive PEM is not delayed. And what about the other reactions that other people get after activity? They deserve answers too.

I feel that up to a point we've lost what ME is thanks to the confusion caused by CFS and continually coming up with different criteria isn't necessarily going to help us. Re CCC v. ICC - are you in or are you out?

As far as I can see, we're all in the same boat now even if what got us here is different. And we do need to be teased apart again but I'm no longer convinced that exclusion or inclusion by criteria is the answer. It has to be research based.

 

[Sasha]

What I particularly need to read are examples from all of you of responses to the P2P draft summary. I can try to do it myself, but expect that more intelligent, comprehensive comments on various lines or sections could be put together by this group. Suggestions would be most welcome! Of course, they could happen later in this thread after some of the questions above feel better answered.

I agree - the discussion on disease criteria is very interesting but it seems to have gone a bit wide (and somewhat beyond my capacity to fathom it in this discussion format) and I'm confused at this point about what the take-home message should be in terms of coming up with a response to the P2P. In particular, this report calls for a committee to tackle the definition question and the IOM is underway and doing something like that (correct me, someone!). Nancy Klimas has said (I think) that IOM is happening two years too soon and that if they'd have waited we'd have a research-based definition (maybe thinking along the same lines as @Jonathan Edwards).

As well as reading the report, I started to go through this thread to make a list of topics I wanted to cover in my P2P letter but only got two pages into this thread. I'll try to do more later if I can but maybe the first topics to come up were the most important ones.

They were:

1. The cost to the US economy isn't $1bn, it's around 20 times that (we have references).

2. There needs to be a call for funds commensurate with that economic burden that is on the same scale as funding for a disease of comparable severity (MS) (we have figures).

3. It's great that the Oxford criteria should be retired.

4. CBT and GET: there isn't evidence of modest benefit, and PACE should be rejected - it's based on the Oxford criteria and heavily flawed.

5. GET is harmful - references to 'fear of harm' should be removed.

6. Further BPS research is positively not wanted by patients, including more research on CBT.

7. We need treatment specialists, not random 'physicians'.

8. We positively don't want research on bizarre and useless complementary therapies such as homoeopathy, mind-body medicine and 'multimodal' ('spiritual') therapies.

There was more stuff to praise than I've listed, which I want to add in

I'll work on my responses and post. I hope others will too.

 

[Sasha]

Here's the link again to Sean's post with his very helpful plain-text file of the report:

http://forums.phoenixrising.me/inde...draft-report-is-out.34480/page-16#post-537739

 

[Bob]

I've just started working on my submission as well. I might post some of my work here but it will be a few days before I do so.

That's a great list Sasha.

I don't know why they have to time this for the Xmas holiday period: it feels like being given school homework for the Xmas holidays.

 

[lansbergen]

I don't know why they have to time this for the Xmas holiday period: it feels like being given school homework for the Xmas holidays.

Normal gorvernment policy.

 

[Sasha]

As well as reading the report, I started to go through this thread to make a list of topics I wanted to cover in my P2P letter but only got two pages into this thread. I'll try to do more later if I can but maybe the first topics to come up were the most important ones.

They were:

1. The cost to the US economy isn't $1bn, it's around 20 times that (we have references).

2. There needs to be a call for funds commensurate with that economic burden that is on the same scale as funding for a disease of comparable severity (MS) (we have figures).

3. It's great that the Oxford criteria should be retired.

4. CBT and GET: there isn't evidence of modest benefit, and PACE should be rejected - it's based on the Oxford criteria and heavily flawed.

5. GET is harmful - references to 'fear of harm' should be removed.

6. Further BPS research is positively not wanted by patients, including more research on CBT.

7. We need treatment specialists, not random 'physicians'.

8. We positively don't want research on bizarre and useless complementary therapies such as homoeopathy, mind-body medicine and 'multimodal' ('spiritual') therapies.

There was more stuff to praise than I've listed, which I want to add in.

Actually, this is quite a big list for me to work on just on my own! Shall we share the work?

I think that what we need for each point is:

(a) the line numbers where the key text occurs, with it quoted;

(b) a simple statement of opinion (e.g. 'I agree that the Oxford criteria should be retired');

(c) any relevant facts and citations (e.g. figures and references on costs of ME/CFS to the US economy) and/or key arguments.

And then, when we write our own letters, we'll have everything we need to put the flesh on the opinion in our own words.

I volunteer to tackle 1, 2, 3, and 8.

Anybody for the others?

What major points did I miss?

 

[Sasha]

Someone mentioned that someone (at the P2P workshop?) mentioned this figure of the cost of ME/CFS to the US economy being $1bn. I've been trying to find that in the caption transcripts but can't. I'd also like to know if Lenny Jason said it at the workshop.

Day 1 captions: http://videocast.nih.gov/vodCaptions/mecfs120914.txt

Day 2 captions (thanks, Bob): http://videocast.nih.gov/vodCaptions/mecfs121014.txt

Here are the links to the video recordings for anyone who wants them:

Day 1: http://videocast.nih.gov/summary.asp?live=14723&bhcp=1

Day 2 (thanks again, Bob): http://videocast.nih.gov/Summary.asp?File=18775&bhcp=1

Edit: I've found the statement on the $1bn, by Dr Green in the captions.

Can anyone remember if Lenny Jason corrected her, and if so, when? I can't find it in the captions using search terms.

 

[Bob]

I volunteer to tackle 1, 2, 3, and 8.

I think I'm focusing most of my efforts of 4, 5 and 6, presenting arguments against the use of CBT/GET.

At the moment, I'm a bit torn, because I want to use the PACE trial outcomes (i.e. a failure to improve physical disability, employment, private insurance claims, and welfare claims) as part of my evidence against CBT/GET, but at the same time, it's based on the 'flawed' Oxford criteria, and I want to point out that much of the CBT/GET research is based on Oxford, so I'm being inconsistent if I'm using PACE as my own evidence. Anyone have any thoughts on this conundrum?

 

[Bob]

I've only been able to locate the captions for Day 1:

http://videocast.nih.gov/vodCaptions/mecfs120914.txt

but not Day 2.

These are the captions for day 2:
http://videocast.nih.gov/vodCaptions/mecfs121014.txt

But i see you've found what you were looking for.

Here are the links to the video recordings for anyone who wants them:

Day 1: http://videocast.nih.gov/summary.asp?live=14723&bhcp=1

Day 2: http://videocast.nih.gov/summary.asp?Live=7674&bhcp=1

Sasha, you've posted the wrong link for day 2. That's the CFSAC meeting. (Which is probably why you couldn't find the captions!)

This is day 2:
http://videocast.nih.gov/Summary.asp?File=18775&bhcp=1

 

[Sasha]

I think I'm focusing most of my efforts of 4, 5 and 6, presenting arguments against the use of CBT/GET.

At the moment, I'm a bit torn, because I want to use the PACE trial outcomes (i.e. a failure to improve physical disability, employment, private insurance claims, and welfare claims) as part of my evidence against CBT/GET, but at the same time, it's based on the 'flawed' Oxford criteria, and I want to point out that much of the CBT/GET research is based on Oxford, so I'm being inconsistent if I'm using PACE as my own evidence. Anyone have any thoughts on this conundrum?

I think you can get them both coming and going Bob. Both barrels!

I think that you can say that PACE should be excluded on Oxford-criteria grounds and that, even for Oxford patients, it demonstrates failure to improve.

 

[Sasha]

These are the captions for day 2:
http://videocast.nih.gov/vodCaptions/mecfs121014.txt [...]

Sasha, you've posted the wrong link for day 2. That's the CFSAC meeting. (Which is probably why you couldn't find the captions!)

This is day 2:
http://videocast.nih.gov/Summary.asp?File=18775&bhcp=1

Oops! I seem to have had an attack of the muppets. Thanks, Bob!

 

[Sasha]

OK, just to give an idea of what I'm talking about, I've tackled (1). Someone mentioned a CDC study but it's based on a ridiculously high (CDC) prevalence estimate of 4 million PWCFS in the US so I'm ignoring it.

These are the facts on which anyone might base this point: anyone can rewrite this how they like and use it.

1. The report’s estimate of the annual economic burden of ME/CFS in the US of approx. $1 billion should be corrected to its true figure of well over $19 billion.

The report states:

Lines 6-7: ME/CFS is an unmet public health need with an economic burden estimated to be greater than $1 billion.

This appears to be based on an incorrect and unsubstantiated statement made by the workshop facilitator, Dr Carmen Green, during her introductory statement at the P2P workshop on 9 December (“As you have heard, ME/CFS is a major health issue for over one million adults, has an economic burden associated with $1 billion”).

In fact, the latest research on economic burden is a 2008 paper by Jason et al. (The economic impact of ME/CFS: individual and societal costs. Jason LA, Benton MC, Valentine L, Johnson A, Torres-Harding S. Dynamic Medicine 2008, 7:6, available at http://www.dynamic-med.com/content/7/1/6).

Using a community-based sample of patients, he estimated economic burden at $18.7 billion; using a tertiary sample, the estimate was $24.0 billion.

Adjusted for 2015, the sums would of course be even higher.​

 

[Jonathan Edwards]

Whose idea was it that “the neuroimmune bit is the cause?” Wasn't that your interpretation of PENE?

It seems from the quote Nielk has given us that it was the intention of the people who defined PENE - exhaustion with a neurological and immune underlying pathophysiology. I think it has to mean that given the wording, otherwise it would be exhaustion plus neuroimmune sympoms. Neuroimmune exhaustion implies that there is something neuroimmune about the exhaustion and the only thing that would make sense is what the definition says - that it the underlying mechanism or cause that is neuroimmune.

 

[Sasha]

Does anyone know of research that compares the disability profile of ME to MS? E.g., % bedbound/housebound?

I'm looking at reasons to argue for funding parity.