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

Ember

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Diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome: Background and charge to the IOM Committee
Thanks so much for the opportunity to speak to you today. This first meeting of the committee is the culmination of a year-long effort at the Department of Health and Human Services (HHS) to support development of clinical diagnostic criteria for myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS).

In 2012, the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommended to the Secretary of HHS that she convene a workshop to reach a consensus for research and clinical case definitions for ME/CFS. Because of the considerable need for faster and more accurate diagnosis for patients, HHS asked the IOM to use its well-established and well-regarded consensus process to provide guidance to the broader medical community on how to identify and diagnose ME/CFS in the clinical setting.

HHS envisions that the recommendations from this study will reach health care providers likely to see patients who may have ME/CFS but haven’t yet been diagnosed. This would include primary care providers, as well as some specialty groups.

HHS has asked that four specific tasks be addressed, which I will walk you through now. For the purposes of this study, HHS uses ME/CFS to refer to conditions that include: Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Chronic Fatigue and Immune Dysfunction Syndrome, Neuroendocrine Immune Disorder, as well as other terminologies. These may be distinct disease entities, part of a spectrum, or a similar phenotypic response to a variety of external or internal assaults on the individual.

Task 1 - Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients.

The first task focuses on reviewing available scientific literature regarding signs, symptoms and diagnosis of ME/CFS. This review would include:

• Published peer-reviewed research on ME/CFS, including proven and potential biomarkers; the pathophysiology, natural history, and epidemiology of ME/CFS; and neurologic, immunologic, infectious, cardiovascular, and endocrine aspects of the disease.

• The review would also include literature describing the symptomatology of ME/CFS. We ask that you consider the variety and range of symptoms, including disease severity.

• It is also important to consider the distinction between generalized chronic fatigue with known etiology, unexplained chronic fatigue without associated multisystem illness, and the more specific syndrome of myalgic encephalomyelitis.

As the committee reviews the literature, we ask that you consider the existing definitions and criteria for ME/CFS, and build upon them as appropriate. As you probably know, there has been support from a number of advocates and experts in the field for the 2003 ME/CFS Canadian Consensus Definition. Some of the members of this committee have gone on the record as supporting these clinical criteria.

The CFSAC recommendation made in 2012 that I mentioned at the beginning of my presentation asked that the reexamination of the ME/CFS case definition process “begin with the 2003 Canadian Consensus Definition.” Perhaps some of the stakeholders speaking later today will discuss why this definition is preferred over the 2010 Revised Canadian version.

HHS believes that it is of prime importance to get stakeholder input into the evidence collection process. We are pleased that representatives from the advocate and patient community are on today’s agenda. We are also pleased that your committee includes individuals with long-standing experience in ME/CFS, both professional and personal.

Task 2 - Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology.

HHS asks that as you develop your recommendations, you:

• Evaluate clinical diagnostic criteria to determine: 1) whether existing criteria are adequate for medical practitioners to diagnose the individual patient with ME/CFS; 2) whether criteria need to be revised; or 3) whether new criteria are needed.

• The criteria should account for the various and distinct subpopulations of individuals with ME/CFS. One subpopulation to consider is children.

• The committee may well decide that different criteria are needed for different disease entities that fall under the broad umbrella of ME/CFS. This could help health care providers distinguish between these different conditions.

• Notably, there is debate whether ME and CFS are distinct entities or different names for the same or similar syndrome.

• As you develop your recommendations, please consider the specificity, sensitivity and reliability of the clinical criteria.

• HHS would also like to have recommendations on a process for revising and updating the criteria in the future as needed.

Task 3 - Recommend whether new terminology for ME/CFS should be adopted.

For the third Task, we ask that you:

• Review the various terminologies that refer to ME/CFS, identify the clinical distinctions among them, if any, and make recommendations for clinical diagnostic criteria for the distinct entities. These terminologies include, but are not limited to neuroendocrine immune disorder; myalgic encephalomyelitis; chronic fatigue syndrome; and chronic fatigue immune deficiency syndrome.

• If the committee decides new terminology is needed for the condition(s), provide recommendations for the new terminology(ies). Different names may be warranted.

Please know that there are many people - scientists, clinicians, advocates – who believe that the name chronic fatigue syndrome does harm to patients. I agree.

Task 4 - Develop an outreach strategy to disseminate the definition nationwide to health professionals.

Lastly, HHS asks that you

• Recommend strategies to disseminate these criteria nationwide to enhance awareness and responsiveness to ME/CFS patients.

• If the committee recommends name changes, incorporate that recommendation in the dissemination plan.

• We ask that you recommend strategies to increase the number of primary and specialty health care professionals who recognize and diagnose ME/CFS, and can distinguish between other conditions causing neuroendocrine immune dysfunction, generalized chronic fatigue and ME/CFS.

We recognize that making a diagnosis is just a first step, and that many of the health care providers who make the diagnosis will not have sufficient knowledge and experience to manage their patient’s complex condition. We also recognize that there are too few providers in the US with expertise in managing ME/CFS. HHS has not asked the committee to address this problem, however.

Pushing out the criteria to a wide audience of health professionals is a critical need. As you know, the 2003 Canadian Consensus criteria are widely embraced by many ME/CFS experts and patient advocates. But they are not well-known beyond these groups. Whatever the committee develops needs to get into textbooks and widely-read journals and be at the top of a Google search. For example, the lead article in the November 6, 2013 issue of JAMA was a summary of a new IOM report on improving quality of cancer care in the elderly. Perhaps, an article about ME/CFS diagnostic criteria will be the lead in JAMA in a couple of years!

To close, 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.

HHS is most grateful for your willingness to take on this challenging task. I have been working with CFSAC for 2½ years. From that position I understand how important it is that all ME/CFS patients have health care providers that know about this serious condition, can make, or at least suspect the diagnosis, and if appropriate, refer to providers experienced in managing their disease. This is a desperate situation for so many, and my hope is that this study will be a major step in improving the clinical care and lives of these patients.

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.

We recognize that coming up with diagnostic criteria may not be easy. We can only hope ongoing and future research efforts will soon make diagnosis much easier. But patients and providers need help and guidance now. We need to go forward with what we know.

Thanks again for what you are doing for the patients with ME/CFS, and their families and friends.

I am happy to answer any questions you may have.
 
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taniaaust1

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

We also recognize that there are too few providers in the US with expertise in managing ME/CFS. HHS has not asked the committee to address this problem, however.
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).
 

Firestormm

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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.

Dr Nancy Lee:

"This first meeting of the committee is the culmination of a year-long effort at the Department of Health and Human Services (HHS) to support development of clinical diagnostic criteria for myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS).

In 2012, the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommended to the Secretary of HHS that she convene a workshop to reach a consensus for research and clinical case definitions for ME/CFS. Because of the considerable need for faster and more accurate diagnosis for patients, HHS asked the IOM to use its well-established and well-regarded consensus process to provide guidance to the broader medical community on how to identify and diagnose ME/CFS in the clinical setting..."
I did think that we could have done more about this in our own (and other) presentations:

The CFSAC recommendation made in 2012 that I mentioned at the beginning of my presentation asked that the reexamination of the ME/CFS case definition process “begin with the 2003 Canadian Consensus Definition.” Perhaps some of the stakeholders speaking later today will discuss why this definition is preferred over the 2010 Revised Canadian version.
Then, I never did really understand the bloody question that we were asked!
 

Nielk

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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.
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:

In 2012, the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommended to the Secretary of HHS that she convene a workshop to reach a consensus for research and clinical case definitions for ME/CFS.
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.
 

Firestormm

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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.
 

alex3619

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@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.
 

Denise

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@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."
 

Denise

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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.
 

Denise

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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.
 

Nielk

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

Working Group 1

To investigate strategies to increase the number of capable investigators that are successfully funded for ME/CFS research.

It’s purposefully broad. It’s designed for those researchers who want to do specific ME/CFS research.
We will leave the details of how that will be determined to the working group. I’ve asked Jordan
Dimitrakoff and Dane Cook to co-chair this working group and they’ve agreed to do so. If there are
others who are interested in serving on the group, you can let me know now or you can let us know
later. The goal will be to get these working groups up and moving in the next couple of weeks.

Working Group 2

To develop recommendations for increasing the number of interested and capable healthcare
providers to give the highest caliber of expert clinical care for ME/CFS patients.


That may include things like recommendations for how to develop this specialty of ME/CFS medicine. It
may involve, in the context of what Sue and Lisa were talking about earlier today, a workshop. I’m not
in any way suggesting that is what we should do. I’m giving a possible hypothetical example: a
workshop that the Secretary would fund to bring together the American College of Physicians, the
American Academy of Pediatrics, the American Academy
 

Ember

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How do these two statements work together? Jennie Spotila commented in November:
I think it’s worth remembering that the Federal Advisory Committee Act restricts the degree to which HHS can interfere in this IOM panel. The Act states that a government agency cannot use recommendations from an IOM committee created at the request of the government unless a) the committee was not subject to any management or control by an agency or officer of the government....
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.”
 

Nielk

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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???
 

leela

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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.
 

Ember

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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.”
 
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jspotila

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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.”
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.
 

Nielk

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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?