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

[Ember]

The monthly meetings between IOM and NIH are administrative only.

Progress reports don't need to be delivered in person.

 

[Bob]

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.

Does anyone know if there is an accessible Public Access File on their website yet?

Edit: Perhaps its necessary to request the contents of the Public Access File, as per this webpage:
"Contact the Public Access Records Office to make an inquiry, request a list of the public access file materials, or obtain a copy of the materials found in the file."
http://www8.nationalacademies.org/cp/projectview.aspx?key=IOM-BSP-13-05

 

[Bob]

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.

Thanks for that info, Jennie.

I was surprised/pleased about how strong Dr. Clayton was in addressing this issue.
...
Dr. Clayton is pretty focused on making sure IOM complies with the policies.

Yes, Dr Clayton was very firm and absolute in her statements about contact between the IoM committee and the government. She is chairing the project, so I assume that it's her job to make sure that the committee stays within the law.

 

[Nielk]

Progress reports don't need to be delivered in person.

There is also the issue that some IoM panel members also serve on the P2P workshop panel. In waht way does this make sense?

 

[Denise]

Progress reports don't need to be delivered in person.

Is there a stipulation that these reports will be delivered in person? (There may well be and I missed it --.)

 

[Denise]

There is also the issue that some IoM panel members also serve on the P2P workshop panel. In waht way does this make sense?

One possibility is that there are so few experts for this illness (and even fewer who can take the time from their practices to participate in these projects) that they couldn't help but have some overlap....

 

[Bob]

There is also the issue that some IoM panel members also serve on the P2P workshop panel. In waht way does this make sense?

Do you mean that you see a conflict of interest there, Nielk?

 

[Nielk]

One possibility is that there are so few experts for this illness (and even fewer who can take the time from their practices to participate in these projects) that they couldn't help but have some overlap....

You are kidding...right?

 

[Ember]

Is there a stipulation that these reports will be delivered in person? (There may well be and I missed it --.)

Apparently, the reports require monthly meetings:

meeting
noun
: a gathering of people for a particular purpose (such as to talk about business)
: a gathering of people for religious worship
: a situation or occasion when two people see and talk to each other

re·port
noun
: a story in a newspaper or on radio or television that is about something that happened or that gives information about something
: a written or spoken description of a situation, event, etc.
: an official document that gives information about a particular subject

 

[Nielk]

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.

 

[Denise]

You are kidding...right?

I do not know if it is the reason....
I am offering it as a possibility.
We know that some experts are on the P2P project (until the non-experts take over).
We have had concerns about there not being enough experts on the IOM panel.
Perhaps if those on the P2P weren't allowed to be on the IOM, we would have even fewer experts on the IOM panel.

Again - I am offering this as a possibility.

 

[Denise]

Apparently, the reports require monthly meetings:

meeting
noun
: a gathering of people for a particular purpose (such as to talk about business)
: a gathering of people for religious worship
: a situation or occasion when two people see and talk to each other

re·port
noun
: a story in a newspaper or on radio or television that is about something that happened or that gives information about something
: a written or spoken description of a situation, event, etc.
: an official document that gives information about a particular subject

The term meeting is also used for teleconferences. Perhaps that is what they mean.

 

[Ember]

The term meeting is also used for teleconferences. Perhaps that is what they mean.

Progress reports don't require meetings or teleconferences to be delivered.

 

[Ember]

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....

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.

syn·er·gy
noun
: the increased effectiveness that results when two or more people or businesses work together

 

[WillowJ]

I thought it was good that Nancy Lee moved away from an insistence that it had to be PCPs who would be the point docs to diagnose and care for us

 

[jspotila]

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?

How could I possibly do that? That's a question better directed to IOM or Dr. Maier. One possibility that leaps to mind, though, is "we want to make sure it looks like we're doing lots of stuff and we know what we're doing." Or from IOM's perspective, "the Statement of Task requires us to coordinate and that can only happen publicly so here ya go." Speculation on my part, though.

 

[jspotila]

There is also the issue that some IoM panel members also serve on the P2P workshop panel. In waht way does this make sense?

Are you saying you object to Klimas's involvement on one or both committees? I think a better question is whether the overlapping members have received clear instructions about how to manage these two separate workstreams appropriately without compromising either one. From Klimas's comments on Monday, as of then she had not received clear instructions.

 

[Nielk]

How could I possibly do that? That's a question better directed to IOM or Dr. Maier. One possibility that leaps to mind, though, is "we want to make sure it looks like we're doing lots of stuff and we know what we're doing." Or from IOM's perspective, "the Statement of Task requires us to coordinate and that can only happen publicly so here ya go." Speculation on my part, though.

.

Are you saying you object to Klimas's involvement on one or both committees? I think a better question is whether the overlapping members have received clear instructions about how to manage these two separate workstreams appropriately without compromising either one. From Klimas's comments on Monday, as of then she had not received clear instructions.

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?

 

[Ember]

There is also the issue that some IoM panel members also serve on the P2P workshop panel. In waht way does this make sense?

That makes sense as part of the HHS effort "to minimize overlap and maximize synergy...[assuring] that relevant information is shared and that key messages are coordinated." Although Dr. Maier redirected Dr. Klimas' request for permission to share a P2P Working Group document with the IOM Committee, Dr. Klimas cannot fail to share information with herself. Two members serving on the IOM consensus committee find themselves in that position.

 

[Nielk]

The task for the IoM study:

to review evidence of all case definitions in use

The task of the P2P workshop:

to review evidence of all case definitions in use

Nancy Klimas stated on Jan. 27th IoM meeting that since they are both doing the same review there is a need to share information but, because the IoM will not come out with their study untilit is ready for revelation at the end of the 18 month period, this 'sharing' of information will only be 'one way sharing'. In other words, P2P will share their work and conclusions with the IoM.

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?