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

[Ember]

Why do we have these parallel works going on at the same time? Is this P2P wprk in order to ensure that HHS has input the IoM study?

The P2P process is expected to be “an excellent adjunct to the discussions around the clinical definition,” according to the CFSAC minutes:

Dr. Lee: Let me also say that the department took the recommendation which asked for research and clinical definitions and let that be advice from the committee. The original recommendation said something about working on both clinical and research definitions. What we decided to do with that amidst a good bit of controversy among the subcommittee calls—which I don’t think we have the time to revisit—we discussed that NIH had the wonderful and already funded process to think about the research case definition. It may not be the goal of the workshop to come out with a research case definition, but there will be so much good evidence that that can be the next step. We are now actively pursuing methods to address the clinical research definition part. I think we should not discuss this anymore because I don’t want to take up the rest of the day. [To Dr. Fletcher] You’re interrupting me. You’re interrupting me. Remember, we’re not supposed to do that.

Dr. Fletcher: This doesn’t respond to our recommendation at all. Dr. Maier said that her workshop is not to create a case definition. That’s not its purpose.

Dr. Lee: Let me finish, please. What I said, and what Dr. Maier has said to me, is that this will give us a very good next way to go to look at the research case definition, because we’re now going to have the evidence. It’s going to be the evidence review. The process for the workshop will be an excellent adjunct to the discussions around the clinical definition, and we are actively pursuing options for that.

 

[Bob]

Lili Chu asked a question of Susan Maier regarding the two works of the IoM and P2P committees.

This was her answer:

There is a link with what IoM & P2P committee is doing. We hope to be working together with the IoM committee...no doubt there is a need to share that synergy.

I think that she was pretty clear as to the intentions here and I did not hear any red flag protests from anyone present there, including the chair.

If Jennie's information is correct, then they can legally share documents as long as they are placed in the public domain.

If Jennie's information is correct, then the IOM committee can receive any documents from the P2P process, as long as the documents are placed in the public domain

The term "working together" could be interpreted to mean an inappropriate methodology, but it depends on what exactly it means. If it simply means sharing information, transparently, then that seems to be permissible.

I guess my questions are due to my great confusion as to the true 'independence' of this IoM study. The IoM states that once the study is started, the sponsors may not have any input into the ongoing study.

HHS states that the reason they contracted with the IoM because the government is not in the business of criteria producing. Diagnostic criteria for diseases should come from doctors and clinicians.

Yet, it seems that this P2P work which parallels the IoM panel's works, will have 'sharing' capabilities.

In addition, I very much respect Dr. Klimas but, I am not comfortable and I in the sake of transparency, it does not make sense that the same person serves on both committees. These are supposed to be separate entities. One is a government one and the other an 'independent' private one.

Am I the only one who sees an issue with this?

I think I see what you mean: Information is supposed to be shared with the IOM committee formally and transparently, but Klimas will be able to share information from one committee to another, informally, thus undermining the issue of transparency.

But in practical terms, I can't anticipate much of a problem, myself.
Nancy Klimas knows here stuff, and I can't imagine that her opinions will be influenced massively by her attendance at either committee.
And the other IOM committee members shouldn't be influenced by any new information that Klimas is in possession of unless she shares it formally.

But I'm pretty ignorant about the process of both committees, so these are just my casual thoughts/observations.

 

[jspotila]

Why do we have these parallel works going on at the same time? Is this P2P wprk in order to ensure that HHS has input the IoM study?

THAT is the $64,000 questions, isn't it? Especially since the IOM process was the last to be initiated of the three overlapping efforts.

In terms of the appropriateness of two individuals serving on the P2P Working Group and the IOM committee, given that the Working Group was supposed to have met in October 2013, it seems likely to me that the Working Group was selected and these two agreed to serve. The invitation to serve on IOM came later. The Working Group serves the function of planning the P2P meeting, rather than reviewing the evidence itself. So perhaps that is why IOM did not perceive this as a conflict. But clear instructions should be given about the sharing of information and the legal restrictions on that. We have to rely on IOM and the people involved to self-police since the IOM meetings are not public.

 

[jspotila]

If Jennie's information is correct, then they can legally share documents as long as they are placed in the public domain.

Just to be crystal clear, documents and information from HHS on the substance of the IOM study can only be shared with the IOM committee if it is done publicly. No documents or other information from the IOM committee can be shared with HHS at all. Period.

 

[Ember]

But clear instructions should be given about the sharing of information and the legal restrictions on that. We have to rely on IOM and the people involved to self-police since the IOM meetings are not public.

How can there be clear instructions and legal restrictions on sharing information with oneself?

 

[jspotila]

How can there be clear instructions and legal restrictions on sharing information with oneself?

There are legal restrictions on the sharing of information to parties outside the IOM process, specifically to HHS and its agencies. Dr. Klimas is not violating those restrictions if she keeps the information to herself. But if she discloses anything about the committee's deliberations to anybody outside the IOM process, she will be in violation of IOM policy and presumably vulnerable to removal. If she shares information from HHS with the IOM panel in a nonpublic way, she and IOM will be in violation of FACA.

If you think that it is inappropriate for Dr. Klimas to be on both committees, that she cannot be trusted to manage these parallel information streams, you are certainly free to write to IOM and ask that she be removed from the committee because of her disclosure that she is also serving on the P2P Working Group. Personally, I do not share that view.

 

[leela]

I believe Klimas to be of the highest integrity, and am kind of glad she's on both commitees.
Even though I still don't understand the real purpose of either stupid commitee!

 

[Ember]

If she shares information from HHS with the IOM panel in a nonpublic way, she and IOM will be in violation of FACA.

Dr. Klimas and the other member serving on both groups can't help but share information from HHS with the IOM panel. They comprise 13% of the panel. Why is it acceptable for HHS to share information with 13% of the panel?

Is it an FACA violation if the committee is subject to any management or control by an agency or officer of the government but that management or control takes place in public?

 

[Denise]

There are legal restrictions on the sharing of information to parties outside the IOM process, specifically to HHS and its agencies. Dr. Klimas is not violating those restrictions if she keeps the information to herself. But if she discloses anything about the committee's deliberations to anybody outside the IOM process, she will be in violation of IOM policy and presumably vulnerable to removal. If she shares information from HHS with the IOM panel in a nonpublic way, she and IOM will be in violation of FACA.

If you think that it is inappropriate for Dr. Klimas to be on both committees, that she cannot be trusted to manage these parallel information streams, you are certainly free to write to IOM and ask that she be removed from the committee because of her disclosure that she is also serving on the P2P Working Group. Personally, I do not share that view.

This is the email address to use to send material, questions, concerns to IOM (NOTE -- it likely will all go into the Public Access File)
mecfs@nas.edu

 

[Bob]

How can there be clear instructions and legal restrictions on sharing information with oneself?

I think you make a good point that being on both committees makes a mockery of the rules regarding the sharing of information.
However, as it's Nancy Klimas it doesn't both me personally.
I'm not certain why it does bother anyone, in pragmatic terms, as I can't really see Nancy Klimas being corrupted, and suddenly turning 'rogue' on us, just because she's on two committees.

 

[Ember]

However, as it's Nancy Klimas it doesn't both me personally.

My concern isn't about Dr. Klimas' integrity but about the integrity of the process. (Nobody seems to know who the other member serving on both groups might be.) HHS has clearly requested that the IOM committee coordinate with two ongoing HHS efforts concerning ME/CFS in order to minimize overlap and maximize synergy. How will the fact that some members might have privileged information in this regard affect the dynamics of the consensus process?

 

[Bob]

How will the fact that some members might have privileged information in this regard affect the dynamics of the consensus process?

You've got valid questions, but I guess we won't know the answers unless we ask them directly for clarifications.

Also, keep in mind what Jennie said about Klimas serving only on the planning part of the P2P process.
If she isn't serving on the P2P panel that reviews the evidence, and that makes conclusions, perhaps it isn't such a conflict?
(I don't yet understand the P2P process - I need to read up on it - So I'm just offering thoughts and observations here - Ignore me if I'm being unhelpful.)

 

[jspotila]

You've got valid questions, but I guess we won't know the answers unless we ask them directly for clarifications.

Also, keep in mind what Jennie said about Klimas serving only on the planning part of the P2P process.
If she isn't serving on the P2P panel that reviews the evidence, and then makes conclusions, perhaps it isn't such a conflict?
(I don't yet understand the P2P process - I need to read up on it - So I'm just offering thoughts and observations here - Ignore me if I'm being unhelpful.)

The key thing to remember is that the P2P Panel that makes the final recommendations will have NO experts - zero ME/CFS experts - on it. Here's my writeup of the process: http://www.occupycfs.com/2014/01/06/behind-closed-doors/

 

[leela]

What I don't understand is, according to Susan MyOhMyWe'reHavingSuchFun HereToday, they've been working on the P2P thing for a year and a half. Am I the only one that had never heard of it, doesn't know what its purpose is, and cannot fathom why there is yet *another* committee reviewing an unknown quantum/selection of ME/CFS data that has no experts? Considering our collective response the IoM contract and its panel, I'm guessing this is the first time the community as a whole has heard of P2P and its expertless panel of mysterious data reviewers.

Can someone explain then why, if this group has been underway for some time, the IoM contract was engaged?
I am utterly confused at this point; and this may all come down to the usual chaotic disorganization of various government agencies having crap communication skills and weird budgetary regulations dictating redundant and/or useless activity.

The big question is this: if P2P and IoM come to different conclusions, never mind that neither entity ought to be creating a disease definition--when the hell has that ever happened--what then? Is this just going to further perpetuate the myth that there is inconclusive or contradictory data to support that this is an organic physiological disease?

 

[leela]

Okay, Just read @jspotila 's excellent post about this.
My first reaction is that those questions (thank you jennie!) are the questions that ought to be investigated by medical researchers in the field.
How is it possible that a secretly chosen group of random individuals is given this secretly chosen task, the task that his been effectively denied to most research scientists via an almost complete lack of governmental funding in the first place?

This has moved into theatre of the absurd.

 

[jspotila]

What I don't understand is, according to Susan MyOhMyWe'reHavingSuchFun HereToday, they've been working on the P2P thing for a year and a half. Am I the only one that had never heard of it, doesn't know what its purpose is, and cannot fathom why there is yet *another* committee reviewing an unknown quantum/selection of ME/CFS data that has no experts? Considering our collective response the IoM contract and its panel, I'm guessing this is the first time the community as a whole has heard of P2P and its expertless panel of mysterious data reviewers.

The first public mention to this workshop was in a February 2013 letter from Assistant Secretary Koh to the CFIDS Association, and it was discussed by Dr. Maier at the May 2013 CFSAC meeting. At the time, the program was called an "Evidence-based Methology Workshop." The Office of Disease Prevention went through "rebranding" in 2013, so now the meeting is part of P2P.

Can someone explain then why, if this group has been underway for some time, the IoM contract was engaged?
I am utterly confused at this point; and this may all come down to the usual chaotic disorganization of various government agencies having crap communication skills and weird budgetary regulations dictating redundant and/or useless activity.

I cannot explain this at all. But it's also important to note that HHS started working on the concept of the IOM study in January or February 2013.

The big question is this: if P2P and IoM come to different conclusions, never mind that neither entity ought to be creating a disease definition--when the hell has that ever happened--what then? Is this just going to further perpetuate the myth that there is inconclusive or contradictory data to support that this is an organic physiological disease?

This is the most important question. By pursuing these efforts on a concurrent rather than consecutive timeline, this is a risk. Again, important to point out that P2P is not going to be coming up with a new definition, though. Still, it is very possible that the evidence review part of the P2P process could end up different from IOM's own evidence assessment.

 

[Ember]

Still, it is very possible that the evidence review part of the P2P process could end up different from IOM's own evidence assessment.

To guard against such an outcome on the part of the IOM Committee, HSS has issued these directives:

Statement of Work:

Also the committee should communicate and coordinate with the Office of Disease Prevention at NIH regarding their ongoing Evidence-based Methodology Workshop for ME/CFS in an effort to minimize overlap and maximize synergy. The coordination with NIH should assure that relevant information is shared and that key messages are coordinated.

Background and charge to the IOM Committee:

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.

Do these HHS directives amount to "any management and control by an agency or officer of the government?"

 

[leela]

what a mess this all is.

 

[justinreilly]

Someone asked if HHS managed or controlled the IoM process publicly would that violate FACA?
Yes it would.

Jennie, do I have this right that there are two statutory provisions-
One is that things submitted by HHS and others (on the substantive subject-matter?) to IoM have to be put in the public file and
Two is the FACA provision that HHS cannot 'manage or control' the IoM process.

If so, then there are two potential violations of provision two that HHS can't manage or control IoM:
one is the "coordination" to create "synergy", whatever that is (presumably to include HHS sending documents from the P2P process to the panel, potentially a violation whether or not they are placed in the public file) and
two, the existence of Klimas and the other member on both committees.

I am a bit concerned about Klimas. Mostly she is good, but there is a reason she has always been funded by NIH and always included on HHS committees on ME. Three (of the reasons) are she recommends CBT and GET and calls the disease 'chronic fatigue.' There maybe more.

More concerned, of course, about the unknown member.

She and the other member are most probably being told what HHS wants from definitions and hoping they will convey this in some way, overt, covertly, consciously or subconsciously to the IoM panel.

 

[justinreilly]

It was a little weird how Clayton jumped all over Eileen about the committee will not provide info to HHS, but didn't say anything to Maier or Lee about it.