Dr. Nancy Lee: Background and charge to the IOM Committee

Diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome: Background and charge to the IOM Committee

 

umm can someone please tell me what the TWO ongoing HHS efforts concerning ME/CFS are which IOM will be coordinating with?

Why hasnt HHS not asked the committee to address this problem? Do they not want to end up hearing from the committee that that issue would be solved if all doctors were were trained in ME in medical school .

Im curious if after all this, if there will be still an attempt to hide this illness by not training doctors in it (its just another way of trying to make it go away).

 

I think what was of importance for me in the above, was learning that IOM was part of the process initiated by CFSAC and not - as we were led to believe - that CFSAC were in opposition to it. Though Holderman appeared to be of a different opinion in her own presentation later.

I did think that we could have done more about this in our own (and other) presentations:

Then, I never did really understand the bloody question that we were asked!

 

HHS has consistently stated that this rush contract for a study with IoM to re-define ME/CFS is a direct result of the 2012 CFSAC recommendation.

This has been contested by CFSAC members, experts, advocates and patients.

This is what Dr. Lee stated at the IoM meeting the recommendation was:

The actual wording of the recommendation reads:

‘that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes. (10/12)’

Facts she conveniently left out:

- a workshop of ME/CFS experts, patients and advocates
- in consultation of CFSAC members
- beginning with the 2003 Canadian Consensus Definition

When you strip all the crucial elements of a recommendation (or any task, statement of work) you are left with something totally divergent from the original intent. Yet, they feel they can not only get away with it but, boldly state that this study is in result of the recommendation.

 

I agree. Based on what was said by CFSAC there should have been more discussion beforehand and CFSAC should have been in agreement with any recommendation to involve IOM. We aired those views before the shadow-dance commenced.

I don't suppose HHS had to have a workshop, but they might have said why they weren't willing to go down that route, and explained the apparently sudden decision to spend the money and get IOM involved.

That decision does not appear to have been discussed with CFSAC if my memory serves me right, and if of course CFSAC have not held-back any of the details.

You don't think that HHS believe what occurred the other day with IOM was the intended 'public' involvement with stakeholders, do you? I mean that they feel now this was 'the next best thing'?

n.b. Nancy does quote the 3rd of your points.

 

@Firestormm, this has been discussed before. CFSAC most definitely did not ask for this. This is the HHS response to CFSAC, yes, but its not what CFSAC asked for. This may come out in March, as a CFSAC webinar will be specifically discussing two studies, I think the IOM and P2P, but I am not sure as we also have the CDC study.

 

I agree that the charge (by DHHS) to IOM does not comport with the CFSAC recommendation.

I think there may be (and ought to be) discussion about the IOM and P2P during the March webinar but the email from the CFSAC Listserv says that the main purpose of the webinar is to have discussion on "the potential recommendations coming from the two workgroups."

 

Hi Denise, I presumed the two workgroups were the IOM and P2P, are there CFSAC workgroups this relates to? I do not have more specific information.

 

Since none of these things are ever clear, I totally get why you (and anyone else) would think that the workgroups might be IOM and P2P.
The workgroups the CFSAC Listserv email refers to are the CSFAC working groups that have been established to develop recommendations to the Sec of HHS. Currently those workgroups are addressing education of medical professionals, and recruiting medical professionals to work on things related to ME. (My wording is way off but I think this is the gist of it.)
My understanding is that once the recommendations have been developed and addressed (voted on/modified/etc) by CFSAC, the recommendations are then sent to the Secretary and new topics are selected for CFSAC workgroups to address.
Hope that makes it a little bit clearer than mud.

 

Thank you @Denise for clarifying this for us. I really hope they can get somewhere with those workgroups. CFSAC has mostly been ignored, or like the current IOM situation, their recommendations have been distorted.

 

I am glad to help.

I too hope the recommendations developed by the CFSAC workgroups get us more traction within DHHS. I won't hold my breath on it, but I hope they do.

 

From the minutes of the May 2013 CFSAC meeting - http://www.hhs.gov/advcomcfs/meetings/minutes/cfsacmay23_final_508.pdf

 

Thanks Gabby

 

How do these two statements work together? Jennie Spotila commented in November:

But Dr. Lee closes here, “HHS has requested that the IOM committee coordinate with two ongoing HHS efforts concerning ME/CFS in order to minimize overlap and maximize synergy. You will be hearing more details from Drs. Unger and Maier today.”

 

This is a great question @Ember. It's a red flag for me. HHS and IoM has yet to clarify how this inconsistency is supposed to work.

At the one hand, at the first meeting of the IoM which was for the purpose of clarifying the task - statement of work; we have four government agency members speaking and two of them present their current work as a continuing joint endeavor.

Yet, this IoM study has to be free of government input?

The biggest farce was the long drawn out process explanation of the P2P, as played out by Mayer. This workshop has just started and has a long way to go until any results will be known. Why bother explaining this process to the IoM panel if it will have no common function???

 

I remain completely puzzled by this. I still fail to see what the relevance was to yesterday's meeting.

 

Can anyone make sense of these two statements?

The Statement of Work reads, “A widely accepted clinical definition and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic and translational research.”

Here Dr. Lee concludes, “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.”

 

This one takes the cake: “We are also pleased that your committee includes individuals with long-standing experience in ME/CFS, both professional and personal.”

 

I was surprised/pleased about how strong Dr. Clayton was in addressing this issue. FACA and IOM policy dictate that any substantive contact about the topic of the study and panel deliberations between IOM and the HHS must be public. MUST BE PUBLIC. So any material about the substantive work of the study coming from NIH or CDC or AHRQ or Nancy Lee, etc. must go into the Public Access File. If they break this rule, HHS cannot use the study report - by law.

The monthly meetings between IOM and NIH are administrative only. As in "we spent x hours gathering research, the panel meant once by phone for an hour, etc etc." This makes sense because the government certainly has an interest in making sure IOM is actually performing the work they were contracted to do. But those meetings CANNOT include any discussion of what the panel is discussing, what NIH thinks about definition, etc etc.

My takeaway from watching the discussions around this question was a) Lee/Unger/Maier have not actually thought through what coordinating for synergy means in light of these restrictions and b) Dr. Clayton is pretty focused on making sure IOM complies with the policies.

 

Jennie,

Can you explain then, the purpose of NIH's Susan Mayer's lengthy discourse of the entire process of the P2P to the IoM panel?