The P2P Draft report is out

[Bob]

..especially in light of the fact that the Public Comment period will end on 1/7/2015

Just making sure we're all agreed that the closing date for comments is 16th January?

 

[Bob]

Another weakness of the evidence base for the CBT/GET research is that it's non-blinded (i.e. "open label".) So it's not of the same high standard expected from the best pharmacological research. This is another reason to question their claims that CBT/GET have any actual therapeutic benefit, esp considering the weakness of their evidence base.

 

[Wally]

Just making sure we're all agreed that the closing date for comments is 16th January?

@Bob,
My mistake in referencing the 1/7/2015 date to the P2P Draft Report. The 1/7/2015 date is when a request to make a public comment at the 1/13/2015 CFSAC meeting must be submitted. I will edit my post in this thread to reference the correct date.

 

[Sasha]

Control freak questions:

Are we sure it's OK to submit a comment in the form of an attachment, such as a pdf file (as opposed to putting it all into the text of the e-mail)?

Dunno - I'd feel safer with body text but you could do both.

Are we sure they will consider comments from outside of the US?

Can't hurt to send it. We'll all be affected by what the US does.

 

[Sasha]

For anyone who wants it, this is Jennie Spotila's question from the floor about why PACE wasn't being ditched when Oxford was, and the response (I don't know who was responding).

I've done a global transform from caps to lower case, which is a bit easier to read - but as you can see, it's still a bit of a mess and the transcription isn't perfect.

>> my name is jennifer spitilla [Spotila] parent advocate and writer. i have a question for all the speakers. i want o go to dr. smith's suggestion that the oxford definition should be retired. the evidence rated the pace trial as good quality then we had dr. snell quoting the pace trial manual, about the assumptions behind these c b t and ged treatment.

so i was an attorney, before i got sick so i hope you will indulge me with the leading question which is if the oxford definition should be retired and it should, doesn't that lead to the obvious conclusion that oxford's studies should also be retired at least as they apply to the me/cfs population. [applause]

>> i kind of opened that can of worms. i'll start speaking. can you speak up a little bit too? >> yes. when with we rate the quality of the study, we are rating it based on specific methodological standards. and the methodology that that pace trial underwent was actually good.

it fulfilled those methods that we're looking at. i think thinking about its inclusion criteria as far as the oxford case definition, i think that's totally different question than was the pace trial well conducted. there's a lot of things that we can talk about that one trial, regarding other forms of bias and such. but i think the two are very different questions.

as far as retiring the oxford case definition and therefore retiring all studies that were associated with it, t i'm not sure that's the best way to move research forward. because sometimes as we spoke about this morning or earlier this afternoon on the map network sometimes it's important to spread -- to put a wider net to get some information before drawing to narrower -- to a narrower spectrum, i think some of the oxford studies may give us some clue as to where to go. with things.

but that said, when we think about where do we go from here, and what i spoke to today about diagnosis and methods of diagnoses, when you're using a case definition as a reference standard that maybe including other patients with other fatiguing illnesses and not just me/cfs patients but that's the reference standard that's being used, these new diagnostic methods may not be as good or specific and sensitive we want them to be.

when we look at those seven studies that compared different case definitions, to see the concordance or how they differ, none of those studies were comparing to the oxford case definition. so there's a fair bit of suggestion here that we may be including patients that have other fatiguing illnesses by continuing to use the oxford case definition as a reference standard. but i certainly want to make sure that we're still looking at the evidence that currently existses and seeing what we can gather from it.

>> that is an excellent question. definitions are based on consensus, not empirically derived. that said, consensus definitions are fine as a gad start off point to -- so you can standardize standardize how you screen people into studies. on one end you have oxford which is broad and includes diagnoses that shouldn't be there, on the other hand you have very narrow definitions requiring a lot of imtoms and that presents its own problems.

also you're going to fold in high symptom conditions other than cfs me. so my feeling about it is i don't think any case definition really we reached an end point with any of them and say we're going to do this and discard all of them. we need an empirical definition based on something as simple as symptom frequencies. what are actually the most frequent symptoms. that's what should be in there. the low frequency symptoms shouldn't be in there. have we reached that point? no we haven't. but that's what ultimately the best case definition is going to be.​

 

[Sasha]

It seems to me that there's simply no coherent argument there to address.

 

[Ember]

It seems like the intention is for all three efforts; the IOM, the CDC study and the P2P to work in "synergy".

In her charge to the IOM Committee, Dr. Lee anticipates synergistic outcomes too: “Another benefit is that widely accepted and widely disseminated clinical diagnostic criteria will facilitate the research efforts that are needed to understand and to treat ME/CFS.”

 

[Valentijn]

As far as I can tell, for CBT, the combined improvements would be slightly less impressive without the Oxford studies, but it wouldn't make a huge difference. Perhaps it would lower the weighted mean difference from approx 7.7 points to roughly 5.5 points on the SF-36 Physical Function scale. Perhaps that's enough to reduce the effect size from medium to small? But I'm not certain about this. It might still be a borderline medium effect size. I think a small effect size is usually considered not to be clinically useful, which might make a significant difference to the report, depending on how they decide to interpret it.

When one of the panelists gave a presentation on the review of the research, I'm pretty sure she said that 7 is used as the cut-off point for being clinically useful. Hence getting the points to anything under 7 for CBT or GET would be quite useful in showing how useless they are for ME/CFS patients (versus CF patients).

 

[Hope123]

As stated in my earlier postings (Reply #509 and #511 at http://forums.phoenixrising.me/inde...draft-report-is-out.34480/page-26#post-540060), I had asked the ODP if public comments to the P2P Draft Report would be available for review by the public. The response to this question from ODP via Paris Watson was that the "Public comments are forwarded to the panel and are not retained".

I had e-mailed and called the ODP last week to ask for clarification regarding Ms. Watson's statement that these comments would not be retained. I was able to reach the ODP through Ms. Watson this morning by phone. She said that she had been out of the office during part of last week and she had just returned to the office this morning (1/5/2015), but the ODP was already working on a response to my follow-up question. I asked when she thought this response would be complete and she said they did not know and she could only confirm that the ODP was currently working on a response.

I expressed the urgency felt by many in the patient community to have a response to this question as soon as possible, especially in light of the fact that the Public Comment period will end on 1/16/2015. I also asked if the response by the ODP to my question regarding retention of Public Comments to the P2P Draft Report could also address whether Public Comments received (either orally or in writing) as part of the P2P workshop would be retained by the P2P Panel and/or the ODP/NIH/HHS and if these comments would be available for review by the public. Additionally, if these comments would not be retained what is the reason for this decision.

As soon as a response to these follow-up questions is received, I will post the response in this thread and the other two threads ("Responses to Individual Points in the P2P Report" and "CFSAC Meeting Scheduled for January 13, 2015") where this topic has been raised.

I appreciate your efforts. If you have Ms. Watson's phone number, can you list it here or PM me? I may have an alternate way of getting at the answer.

I would still urge people to send in comments to CFSAC if possible as there is no telling what the answer from Ms. Watson will be or when it will be released. It's better to be safe -- CFSAC is obligated to post public comments by federal law (http://www.rcfp.org/federal-open-go...-meetings-laws/federal-advisory-committee-act) -- than sorry. Also, CFSAC's meeting on Jan 13 is especially for the purposes of responding to NIH P2P and our letters may give them ideas of how to respond.

 

[Wally]

@Hope123 - Here is the information for both Paris Watson and David Murray. I initially corresponded with David Murray and then he subsequently had Paris Watson reply to my questions.

Paris A. Watson
Senior Advisor
National Institutes of Health | Office of Disease Prevention
Phone 301.496.6615 | watsonpa@od.nih.gov | http://prevention.nih.gov/

David M. Murray, Ph.D.
Associate Director for Prevention
Director, Office of Disease Prevention
Office of the Director
National Institutes of Health
NIH/OD/DPCPSI/ODP
tel: (301) 496-1508
fax: (301) 480-7660 6100 Executive Boulevard, 2B03
david.murray2@nih.gov<mailto:david.murray2@nih.gov> Rockville, MD
20892

 

[Hope123]

@Hope123 - Here is the information for both Paris Watson and David Murray. I initially corresponded with David Murray and then he subsequently had Paris Watson reply to my questions.

Paris A. Watson
Senior Advisor
National Institutes of Health | Office of Disease Prevention
Phone 301.496.6615 | watsonpa@od.nih.gov | http://prevention.nih.gov/

David M. Murray, Ph.D.
Associate Director for Prevention
Director, Office of Disease Prevention
Office of the Director
National Institutes of Health
NIH/OD/DPCPSI/ODP
tel: (301) 496-1508
fax: (301) 480-7660 6100 Executive Boulevard, 2B03
david.murray2@nih.gov<mailto:david.murray2@nih.gov> Rockville, MD
20892

Thanks.

 

[Liz Willow]

Jerrold Spinhirne has written an excellent comment criticizing the P2P report. It's available as a Google document which makes it easy to share. Jerry has submitted this as a public comment to the January CFSAC meeting.

https://drive.google.com/file/d/0B4uD-VyWmIw2b1pXMzZOZWVUUE0/view?pli=1

 

[Marylib]

Thanks for that Liz Willow. It is an excellent article and I hope all will read it.

 

[Bob]

When one of the panelists gave a presentation on the review of the research, I'm pretty sure she said that 7 is used as the cut-off point for being clinically useful. Hence getting the points to anything under 7 for CBT or GET would be quite useful in showing how useless they are for ME/CFS patients (versus CF patients).

Thanks for that, Valentijn.

If that's the case, then to reiterate what this means: removing all the Oxford-based studies from their evidence, may mean that CBT fails to demonstrate a clinically useful benefit, for ME/CFS patients. Whereas their current evidence does demonstrate clinical usefulness if the Oxford (chronic fatigue) studies are included.

Edit: So perhaps we should ask them to remove all the Oxford studies and then to reassess the evidence re the clinical usefulness (or effectiveness) of CBT, when the evidence only includes ME/CFS patients; and to ask them to acknowledge the weakness of the evidence base of the single study that would be included in their evidence for GET.

 

[jspotila]

It seems to me that there's simply no coherent argument there to address.

Wow, @Sasha I almost sounded coherent!

 

[alex3619]

Another weakness of the evidence base for the CBT/GET research is that it's non-blinded (i.e. "open label".) So it's not of the same high standard expected from the best pharmacological research. This is another reason to question their claims that CBT/GET have any actual therapeutic benefit, esp considering the weakness of their evidence base.

Not even single blinded, primarily based upon subjective evidence, and not placebo controlled. Its NOT gold standard.

 

[A.B.]

Edit: So perhaps we should ask them to remove all the Oxford studies and then to reassess the evidence re the clinical usefulness (or effectiveness) of CBT, when the evidence only includes ME/CFS patients;

I think the apparent effectiveness of CBT is an artifact of poor research methods, much like the placebo effect. What we really need are some objective measures of improvement and long term follow ups.

 

[Sing]

What we really need is NIH financing to expand or replicate the promising studies already made by our experts, so that those can result in diagnostic markers, tests and treatments for the biological illness which we have, or variations of such which are present. We don't need them retracing their steps in fruitless directions as before, using too general and inaccurate criteria and pursuing psycho-social or alternative (snake oil) approaches. I want to see them build on the good biological research which has been started. I want them to fund our most expert researchers to expand their work and clinical care--to use and build upon the intelligent expertise already present instead of chasing off after the chimera of the past.

 

[Sasha]

Wow, @Sasha I almost sounded coherent!

I didn't mean you! I didn't mean you!

I meant the person who replied to you!

 

[jspotila]

I didn't mean you! I didn't mean you!

I meant the person who replied to you!

I was pretty sure you meant the other speaker! But here is my experience of public speaking:

First I'm like: and then I'm like: and then I'm all: and at the end I feel like:

So I'm always a little amazed when the transcript makes me sound anything better than