The P2P Draft report is out

[usedtobeperkytina]

I was scared but optimistic. I know a government agency doesn't take a different path without a "committee" to study it and give recommendation. They have to back up what they do when asked. In such committees, though, you can tell the way it's likely going to go by who they invite to sit on the committee or to speak to the committee. Congressional committees are like that. So, after the workshop, my fear went down. I knew it would reflect advancement. I also noticed all they selected for the panel were women. I noticed one has history with lupus, a disease that is also invisible and hard to diagnose. They had a leader of a pain association, and we all know chronic pain is also dismissed with patients not believed. In fact, I wondered if any of them might know someone with ME/CFS. I notice the chair of the panel deals with public health to underserved people. So she would know about stigma.

I did not expect the AHRQ panel to advise discontinuing Oxford. To be honest, that surprised me in the workshop. But because of what was said during the workshop, I'm not surprised it's in this report. I'm surprised they addressed clinical care and educating physicians. Also mentioned bringing in more institutes, collaborating with medical professional organizations and finding a home for it. (I don't know if the last is referring to a home in NIH or specialty home for clinical care. Either way, it's good.) I'm surprised all these are mentioned because I don't think it's on point to research gaps, what they were charged to report on. These issues are more about clinical care.

But no one has mentioned the big surprise to me: The report says again and again that patient views and patient involvement should be included in all future research plans, by government agencies and individual researchers. This is not standard. Imagine if all ME/CFS researchers included three patients to advise and become coauthors on ME/CFS studies.

 

[usedtobeperkytina]

Just to be clear. After learning the process, I estimated that the report and it's results had a 50% chance of bringing beneficial change. But I also knew we had 0% chance of beneficial change at NIH if it was stopped. So while scared, I saw it as an opportunity, and the only one we had for a positive shift.

 

[Sean]

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.

Yes, yes, and yes (though more than a little I think).

 

[Sasha]

Here is one quote from line 235:
"Research is needed investigating the effect of the intestinal microbiome on ME/CFS using cutting - edge technologies such as high - throughput sequencing.

If only we had a world renowned expert who wanted to do such a study? Cant though can we, else it'd already be fully funded and progressing, right? Right?

Donate... donate... donate...

http://www.microbediscovery.org/

 

[RustyJ]

This is just fairy floss. A PR document. If they were intent on making change they would have acknowledged ICC. Anything less is just wasting time.

 

[RustyJ]

I was scared but optimistic. I know a government agency doesn't take a different path without a "committee" to study it and give recommendation. They have to back up what they do when asked. In such committees, though, you can tell the way it's likely going to go by who they invite to sit on the committee or to speak to the committee. Congressional committees are like that. So, after the workshop, my fear went down. I knew it would reflect advancement. I also noticed all they selected for the panel were women. I noticed one has history with lupus, a disease that is also invisible and hard to diagnose. They had a leader of a pain association, and we all know chronic pain is also dismissed with patients not believed. In fact, I wondered if any of them might know someone with ME/CFS. I notice the chair of the panel deals with public health to underserved people. So she would know about stigma.

I did not expect the AHRQ panel to advise discontinuing Oxford. To be honest, that surprised me in the workshop. But because of what was said during the workshop, I'm not surprised it's in this report. I'm surprised they addressed clinical care and educating physicians. Also mentioned bringing in more institutes, collaborating with medical professional organizations and finding a home for it. (I don't know if the last is referring to a home in NIH or specialty home for clinical care. Either way, it's good.) I'm surprised all these are mentioned because I don't think it's on point to research gaps, what they were charged to report on. These issues are more about clinical care.

But no one has mentioned the big surprise to me: The report says again and again that patient views and patient involvement should be included in all future research plans, by government agencies and individual researchers. This is not standard. Imagine if all ME/CFS researchers included three patients to advise and become coauthors on ME/CFS studies.

More involvement like the CFSAC? I know some patient orgs are hoping for a bigger slice of the funding pie. Another epidemiological study would be nice.

 

[biophile]

I skimmed it and it seems OK overall. It could have been worse but it could have been better. People on this thread have already mentioned some of the parts I am cautious over e.g. comorbidities and biopsychosocial research. I agree with alex3619's perspective on it and the sandwich analogy. I have doubts that the NIH are going to do much with the report.

While there has been some interesting research in the last 25 years, I have always felt that this NIH P2P effort is the sort of preliminary response that was supposed to happen 25 years ago already. And seeing how slow things have always been, I don't really have much faith it's going to change much anytime soon, not at the rate that we deserve for it to happen.

Something which stands out for me as problematic is this:

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

That figure is way too low (more like $10-25 billion??) and sends the wrong message for the impact of 1 million sick people.

Talk of agreeing on a new definition makes me feel a bit uneasy because of how bad it could go.

I don't think this part goes far enough:

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. Overall, agreeing on a case definition and clarifying comorbidities could launch bench-to-bedside science.

It was refreshing to see the usual CBT/GET hype toned down a bit, but a blanket application of CBT/GET (if that is what they support) has never really been justified by the evidence even as a component of multimodal therapy. The nature of the reported "measurable improvement" is still in question and has "not translated to" far more than just quality of life but a whole range of outcomes that patients find important while CBT/GET proponents claim aren't particularly important.

Which do you find more important, being able to work more and depend on welfare less and go on holidays and do the physical activities you enjoy, ... OR ... (after being lectured repeatedly about how your main problem is that you are misinterpreting your symptoms) scoring a measly 2 points better on a fatigue scale that has a range of 0-33?

If CBT is only useful for coping, then we need access to the coping type of CBT, not the rehabilitation type of CBT. GET has never shown much objective improvement to physical function, so it too is being delivered under misleading pretenses. Maybe GET is helping some patients because of the work put into baseline stabilization, rather than the increase in exercise.

 

[A.B.]

Better than I expected, but the influence of psychobabblers is still visible in the text, and they're still trying to portrait CBT and GET as useful treatment and ME/CFS as psychosocial problem. For whatever reason, they just can't seem to let go.

 

[RustyJ]

If there was a single ounce of credibility in this report they would not have mentioned CBT and GET. I'm sorry, even when you wrap dog doo in Christmas paper, it's still dog doo when you unwrap it. They came out with the same stuff about working with patients when the CFSAC was formed. Look how that has soaked up the years. It's just a way to manage the unruly mob.

These people aren't into fixing a disease, just managing one. I've had ME for 25 years. In that time I have not seen public perceptions, treatment outcomes, or diagnostics improve in the slightest. The only advance in 25 years was the CCC and then ICC. This whole charade is a shell and pea game about sidelining ICC with the suggestion, 'well we probably should look at a new definition'. Really?

BTW, only ICC associates fatigue with endocrine and immunological dysfunctions. CCC doesn't.

 

[alex3619]

That figure is way too low (more like $10-25 billion??) and sends the wrong message for the impact of 1 million sick people.

I have heard $40 billion, though at the P2P presentation they were told $20 billion if I recall correctly. Somehow 20 became 1.

 

[acer2000]

One notable topic that is missing from all of these discussions is the fact that ME/CFS occurs in cluster "outbreaks". This strongly argues for a cause that is either a communicable infectious disease or common exposure to an environmental factor.

 

[alex3619]

They came out with the same stuff about working with patients when the CFSAC was formed

Most of this is more or less old, and we have been promised and promised for decades. Its not the report though, its what the NIH does with this. I would like to see the NIH prove most of our advocates wrong, including me, by actually acting on the report with real funding, and real change.

I have more faith in the Easter bunny or Santa Claus. So prove me wrong, NIH!

 

[alex3619]

One notable topic that is missing from all of these discussions is the fact that ME/CFS occurs in cluster "outbreaks". This strongly argues for a cause that is either a communicable infectious disease or common exposure to an environmental factor.

Yes. One of the failures of EBM is that the evidence stratification can exclude analysis of the natural disease course. This was compounded by starting the literature review from 1988.

 

[alex3619]

Better than I expected, but the influence of psychobabblers is still visible in the text, and they're still trying to portrait CBT and GET as useful treatment and ME/CFS as psychosocial problem. For whatever reason, they just can't seem to let go.

It has the form of being evidence based without the substance. Since they adhere to EBM simplistically then they get caught up in the dogma.

For example, in EBM its usual to upgrade studies based on large effect sizes (e.g Lerner's antiviral findings) and downgrade studies based on small effect sizes, failure to double blind, or the major evidence being subjective, all of which apply to PACE.

 

[RustyJ]

It is unusual to go to this much trouble unless there is a specific outcome in mind. Usually, at least in bureaucratic ranks, you deliberately tailor proceedings to ensure the required outcome, much like a lot of scientific investigation into ME. So I have to ask what is being set up? And who are the beneficiaries? Patients will be a long way down the list of priorities.

Anyone thinking... Collaborative? Like the UK model, you know, with US version of fatigue orgs linking up with US version of White and co and bevy of fatigue researchers all holding hands and beaming good thoughts.

 

[Stuart]

Big problem with their own logic, if they agree Oxford brings in the wrong cohort to confound the findings, why cite the very findings that Oxford brings in?

It is these idiopathic 'cf' patients from the watered down original 'cfs' definition, which itself ignored the biological findings in the Incline Village Lake Tahoe Nevada + about 7 other communities outbreak. M.E. is a distinct disease, 'cfs' which has become 'cf' is a dumping bucket of meaninglessness.

They need to start with what IS well defined, M.E. in the ME-ICC definition.

 

[Bob]

I think I must have read a different document to some of the posters on this thread. Perhaps it's all about expectations. There was never going to be anything new in this document. Its purpose was to identify gaps in the research; something we're all too keenly aware of, but something the NIH needs bureaucratic guidance on if it is to invest heavily in the illness.

I think it does an excellent job of repeatedly stating that ME is a serious biomedical illness that needs to be taken seriously with the need for serious heavy-duty biomedical research to be invested in.

There were in total about three brief mentions of CBT, none of them particularly favourable, and it clearly states that CBT is not a primary treatment, that it does not improve quality of life, and that ME is not a psychiatric or psychological illness. Sure, we would have preferred that CBT was completely trashed in the report, but I think they've done the next best thing, especially with the trashing of the Oxford criteria (the importance of which can't be over-emphasised in my opinion.)

The bulk of the report is a million miles away from discussions about CBT; There is an emphasis on the biomedical underpinnings of the illness throughout the report, an emphasis on the need for serious biomedical research, and an emphasis on the need for proper patient care.

I should read it again, but I honestly think the report is ground-breaking in terms of it being an officially recognised and endorsed government document. Imagine anything like this being produced when Reeves was in charge of CFS; it wouldn't have happened. I think we've come a long way with this report, and that this is a good starting point for us in terms of government recognition. It's where we should have been 30 years ago, but it's massive progress, in my opinion, considering the context.

I think it's a very strong document with a few short sections that are weak and could be strengthened. For example, I thought the sections about treatment were fairly weak, but that's because there aren't any proven treatments. The section about brain scans, and other biological measurables, was a pleasant surprise to me, and I think it's potentially very helpful for us.

As an official quotable government document, I think this may prove to be an invaluable document for our community.

We now have a chance to tell them what we think are its strengths, and weaknesses, and to point out what they've got wrong about CBT, and what they've got right about the bulk of the document.

 

[Ecoclimber]

I am well aware of the fact that what government agencies say in public and what they do behind closed doors can be of two different agendas. However, I believe that some patients are reading this report with some strong built-in prejudices which they must guard against.

Lets dissect this to some degree:
There are some positive events that we have not seen from the NIH. The admission by the NIH on the dereliction of duty and treatment by the medical and research community over the last few decades by failing to assess and treat the disease and by allowing patients to be stigmatized is big! This is a huge admission by a governmental agency. It could create liability issues. They admit to stigmatizing patients. Take it to your doctor on your next appointment and show him how @#$k up the medical profession viewpoint is on this as compared to the NIH.

The Oxford criteria (published in the Journal of the Royal Society of Medicine in February 1991) are flawed and include people with other conditions, confounding the ability to interpret the science. Has any government or scientific entity in the UK admitted to this fact? I don't know. This huge.

Making declarative statement by the NIH such as these: ME/CFS, this is not a psychological disease in etiology. ( Meaning it is biological in nature not in the DSM-V manual) ME/CFS is a distinct disease ( note again not psychosomatic disorder or DSM-V disorder ) Futhermore, they repeat themselves later on: ME/CFS is not a psychiatric disease. Has the UK medical establishment or the UK goverment ever pronounce that ME is not a psychosomatic disorder, psychiatric disease or psychological disease?

In effect you have the NIH clearly stating the opposite for the first time of what most of the physicians in the medical profession clearly believe concerning ME/CFS. ME/CFS patients over the last 20 years have been trying to tell physicians that this disease is neither a psychatric disease, nor a psychological disease and that ME/CFS is a distinct disease. Now for the first time you have a paradigm switch on the part of the NIH backing the ME/CFS patient viewpoint which you can you take and show to your doctor. This is big!

Do you really believe that it would it be logical given the fact the NIH no longer believes that ME/CFS is a psychiatric or psychological illness, that the NIH will contnue to research for a cause in that field and develop treatment options?

I don't believe so especialy as they stated so strongly that patients are frequently treated with psychiatric and other inappropriate drugs that may cause harm. Do you believe they will continue treating patients with anti-depressants after admitting to the harmful effects of such treatment? Especially after stating there is biological evidence which is reproducible 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. These are powerful statements that cannot be ignored and they know it. This is why they dismissed etiology of ME/CFS as not having anything to do with psycho-somatic, psychological or psychiatric disorders!

Some patients feel that they didn't mention treatment by neurologists/endocrinologists/immunologists etc. but used the word physicians. In a document such as this, they use the word physicians collectively encompassing all of the fields. Good grief, they are not going to list each and every field of medicine.

As to CBT/GET they admitted that patients do not recover under these programs and only show a modest ancillary increase in managing the disease. There is nothing in the document that this modality will cause a recovery for ME/CFS. They state that thus, they are not a primary treatment strategy. Can you say that about current treatment viewpoints in the UK. Is not CBT/GET the primary treatment strategy along with antidepressants? They further stated that GET graded exercise therapy often causes additional suffering,

There is a lot of work that still needs to be accomplished but it is moving in the right direction. You have the NIH for the first time stating this is a biological disease cause by various biological system failures that require further research. It is very similar to the complexity of MS with various subsets of patients with varying symptoms that require different treament protocols. The etiology in MS is still unknown and patients have post depression, anxiety, etc as associated with any major disease and are offered CBT/GET but that doesn't turn MS into a psychiatric disease.

Don't turn this into more than what it is and this is not from the UK's point of view. Like I mentioned before, it something to build on and they are going in the right direction. But action speaks louder than words. I would like to delve into the action plans from the NIH on funding the research and to establish the systems in place as mentioned in this report.

There are significant gaps in research as mentioned with regards to race, male gender, juveniles etc. that have not been address in prior research.

I like what @Sean had to say. "Don't let the perfect be the enemy of the good"

It's late for me, so I hope this makes sense.

 

[A.B.]

@Bob I have to admit my previous post here was a bit too negative. The good parts of the report outweigh the bad ones.

And I think it does an excellent job of repeatedly stating that ME is a serious illness that needs to be taken seriously with the need for serious heavy-duty biomedical research to be invested in.

Yes, and this is the most important part.

 

[Bob]

After reflection, I frequently find that my opinions can be overly-optimistic, but at the moment I agree with @Ecoclimber's interpretation of the document. I think the document's strengths and potential for transformative change are broadly being overlooked in this thread.