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DHHS - soliciting for study on diagnostic criteria for ME/CFS

Ember

Ember

Senior Member
Messages
2,115
No way to guess how this will turn out…..
Published August 29, 2013
Many view the GWI report as heavy on inadequate and inappropriate treatment approaches (for GWI and ME(cfs) among other things) with emphasis on psychological rather than biological processes....

(By the way, it is estimated than an IOM initiative typically costs one million US dollars.)
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Apparently, the report entitled Gulf War and Health: Treatment for Chronic Multisymptom Illness includes CFS, but not ME, as a comorbid condition.
 
Ember

Ember

Senior Member
Messages
2,115
Guido den Broeder said:
With a starting point of 'ME/CFS', instead of ME, I can see only trouble ahead.
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No commitment has been made for this consensus committee to review either “criteria for the diagnosis of” or “existing definitions for” ME. Neither has any intent been stated to “develop consensus clinical diagnostic criteria for this disorder.” Following ICC recommendations, the committee should treat ME as separate and distinct from CFS and ME/CFS:
Patients diagnosed using broader or other criteria for CFS (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification....

Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric.
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According to the ICC process, “only those criteria that were agreed upon by all authors were included in the final manuscript.” How could this consensus committee, comprised presumably of clinicians, include members of the International Consensus Panel but ignore that panel's work?
 
Nielk

Nielk

Senior Member
Messages
6,970
If you share your concern about this proposed process, take action and send out the letter below.(see here)

Instructions for Emailing HHS:
  1. If you are using the sample email provided below, copy the sample email into the body of an email message.
  2. Add your name to the end of the letter.
  3. Add the Subject Line “Stop the IOM Contract on “ME/CFS” Clinical Criteria”
  4. Copy the following addresses into the ‘TO” and “CC” boxes
TO: Kathleen.Sebelius@hhs.gov
CC: howard.koh@hhs.gov; txf2@cdc.gov; Tomfrieden@cdc.gov; Marilyn.Tavenner@cms.hhs.gov;margaret.hamburg@fda.hhs.gov; Mary.Wakefield@hrsa.hhs.gov; collinsf@mail.nih.gov; richard.kronick@hhs.gov;MEACTNOW@yahoo.com


The CC includes the following individuals:
HHS Assistant Secretary Howard Koh
AHRQ Director Richard Kronick
CDC Director Thomas Frieden
CMS Administrator Marilyn Tavenner
FDA Director Margaret Hamburg
HRSA Director Mary K. Wakefield
NIH Director Francis Collins

The Social Security administration is not included because the agency head’s email is not available yet. The email addressMEACTNOW@yahoo.com is used to track the numbers of messages sent.


Sample Email - To be copied into the body of an email message.

Dear Secretary Sebelius,
I am writing to voice my strong opposition to the HHS proposal to contract with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” I am a member of the ME community and have witnessed firsthand the devastation of this disease. I am extremely concerned that this planned IOM initiative will gravely harm ME patients. Note that I am purposely using the term “ME” to distinguish the disease that has affected me from the overly broad “CFS”.
I oppose this proposal for the following reasons:
  • Two peer-reviewed consensus case definitions, developed by experts in this disease, already exist – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. The CCC has been used both clinically and in research. Both are accompanied by clinical guidelines for medical practitioners, and are well regarded by patients, ME doctors, and ME researchers. Given that expertly defined and accepted consensus clinical criteria already exist, the proposed IOM contract wastes scarce taxpayer dollars and is unnecessary.

  • HHS has inexplicably refused to accept the CCC or the ME-ICC and even questions the hallmark symptoms of ME. Instead, it has promoted an overly broad view of the disease called “CFS”, which does not require the hallmark symptoms. This has confounded ME with depression, deconditioning and non-specific chronic fatigue, has severely impeded research, and is the direct cause of the medical skepticism and inappropriate or harmful treatment recommendations to which patients are subjected.

  • IOM has only been involved in one other study to define a disease, the current effort for Gulf War Illness (GWI). Advocates and the Research Advisory Committee for GWI (RAC) have criticized the IOM report that redefined GWI as the overly broad chronic multisymptom illness (CMI). They further criticized the misguided focus on psychiatric issues and the failure to staff the IOM panel with GWI experts. Given this and IOM’s inaccurate characterization of CFS in the January 2013 IOM report on treatments for Gulf War Illness patients, we have no confidence that IOM is capable of producing a clinical consensus criteria that defines ME as described by CCC, ME-ICC and most importantly, the patients themselves.

  • Ironically, the claimed intent of the HHS-IOM initiative is to develop a consensus definition but this effort has been progressed in secret, apparently for many months and without consultation with key ME stakeholders. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.

  • This IOM initiative does not reflect the October 2012 CFSAC recommendation on the development of a case definition for this disease and in fact is in direct contradiction to that recommendation. CFSAC recommended that a clinical and research case definition be developed in unison, that the effort begin with the Canadian Consensus Criteria and, most importantly, that it be developed by disease experts only.

I strongly urge HHS to abandon its plan for this ill-advised, wasteful, and unscientific initiative.

Sincerely,
<Name>
 
M

medfeb

Senior Member
Messages
491
Thank you for posting this action, Neilk. Its very important that we let HHS know that we oppose this contract especially because of the GWI experience with IOM, the fact that this has been progressed in secrecy and the fact that we already have two consensus criteria, which HHS is rejecting
 
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Email received today from the CFSAC email list:

This email is to inform you about HHS’ ongoing efforts to address the 2011 CFSAC recommendation “to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” In response, NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research, and that HHS was actively pursuing options for a separate effort that would result in a case definition useful for clinicians. Because the use of and audience for case definitions for research and clinical care are very different, it is important to have separate processes to develop them.

HHS is actively pursuing a contract with the Institute of Medicine (IOM) to convene a consensus committee to develop recommendations for clinical diagnostic criteria for ME/CFS as recommended by CFSAC. The IOM is unique in the prestige and authority it possesses among U.S. clinicians, researchers and the public. The reports and recommendations released by the IOM are widely accepted and get extensive coverage in both professional and mainstream media. The IOM has a singular reputation as the gold standard for providing biomedical recommendations on difficult, complex and controversial questions in clinical medicine. As the most respected source for medical consensus, the IOM is in a position to bring together experts, the ME/CFS community, and other stakeholders to develop diagnostic criteria for ME/CFS, so that more clinicians can help patients receive the medical care they need and deserve.

Thanks for your support.
 
Ember

Ember

Senior Member
Messages
2,115
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Nielk

Nielk

Senior Member
Messages
6,970
Bob said:
Email received today from the CFSAC email list:

This email is to inform you about HHS’ ongoing efforts to address the 2011 CFSAC recommendation “to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” In response, NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research, and that HHS was actively pursuing options for a separate effort that would result in a case definition useful for clinicians. Because the use of and audience for case definitions for research and clinical care are very different, it is important to have separate processes to develop them.

HHS is actively pursuing a contract with the Institute of Medicine (IOM) to convene a consensus committee to develop recommendations for clinical diagnostic criteria for ME/CFS as recommended by CFSAC. The IOM is unique in the prestige and authority it possesses among U.S. clinicians, researchers and the public. The reports and recommendations released by the IOM are widely accepted and get extensive coverage in both professional and mainstream media. The IOM has a singular reputation as the gold standard for providing biomedical recommendations on difficult, complex and controversial questions in clinical medicine. As the most respected source for medical consensus, the IOM is in a position to bring together experts, the ME/CFS community, and other stakeholders to develop diagnostic criteria for ME/CFS, so that more clinicians can help patients receive the medical care they need and deserve.

Thanks for your support.
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The recommendation from CFSAC was talking about one workshop for both research and diagnostic criteria - in consultation with CFSAC by experts, patients and advocates.

•
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)
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Why is HHS twisting the recommendation information in order to fill their need?
The IOM might be prestigious but have no experience coming up with diagnostic criteria for diseases.
Why not discuss their intent at the CFSAC meeting?
Why leave everyone in the dark about this - including CFSAC members?

The least that HHS should do at this point is postpone this action until after the next CFSAC meeting where this can be discussed with CFSAC members and ME/CFS stakeholders. If they are not willing to do that then I know where their intentions truly are.
 
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Nielk said:
Why is HHS twisting the recommendation information in order to fill their need?
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A rhetorical question, Nielk?

I think you've answered your own question...

They've done it to fulfil their own needs! It ticks boxes.

They can predict it will have a 'safe' outcome (safe and easy for them), and they think it will keep patients, the department secretary, and CFSAC off their back because they can say that they are doing something.

I haven't become a bit cynical, have I?
 
I

Iquitos

Senior Member
Messages
513
Location
Colorado
It's not cynism -- it's realism. The unseen hand that guides the US government's efforts to disappear this illness and the patients who have it has simply acknowledged that it needs to appear to be doing something, so that is what it's doing. This is for appearances only, at best. At worst, it's an another attempt to define us and our illness out of the biomedical arena.

The fact that there already exist perfectly good diagnostic criteria, without doing a $1million study that wastes more time and money, is our best clue that this is a stalling technique, useful only to provide the excuse that they are "doing something" about it, while jogging in place.
 
Ember

Ember

Senior Member
Messages
2,115
Iquitos said:
The fact that there already exist perfectly good diagnostic criteria, without doing a $1million study that wastes more time and money, is our best clue that this is a stalling technique, useful only to provide the excuse that they are "doing something" about it, while jogging in place.
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Jennie's comments notwithstanding, I can't imagine Dr. Unger's response in May to be about nothing more than ignorance:
It’s hard to have confidence in this sort of process when we see regular jaw-dropping examples of ignorance from federal employees. For example, at the May CFSAC meeting, Dr. Beth Unger of CDC stated that she was not familiar with the work of Dr. Chris Snell on metabolic dysfunction in ME/CFS – despite the fact that they have attended the same meetings where Dr. Snell has presented his work.
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In September 2011, asked about the decision to develop the ICC and PENE, Marj van de Sande responded:
It was the accumulation of research and clinical knowledge that influenced the decision to develop new criteria, however, a few studies come to mind….The 2005 Snell et al study, the first test-retest exercise study, reported that some patients had a dramatic drop in their ability to produce energy following the second test. More exciting post- exertional studies followed – the Pacific Fatigue Lab, Drs. Light, White, Van Oosterwijck, de Meirleir, etc. The test-retest studies not only confirmed that ME patients had pathological responses to exertion, but the abnormalities were greater than expected in many cases. Genetic, neurological, immune, mitochondria and ion transport studies brought greater clarity. (Kerr, Broderick, Klimas, Myhill, etc.)
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Cort describes the Stevens Protocol as “the only test that actually documents post-exertional fatigue, and documents it so well that failing the test is virtually a slam-dunk for a disability evaluation.” He reacted to the sudden and unceremonious closure of the Pacific Fatigue Lab program writing, “Unfortunately the University of Pacific just didn’t get it (anymore) and they abruptly shut down the program recently. Maybe being the leader in a controversial field just got to be too much for them.”

Maybe the CFSAC members who spoke out about being threatened with expulsion for expressing their views are feeling the heat of this controversy too.
 
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
Some thoughts...

I do think this is a good time to tell them that we want ME investigated separately to: chronic fatigue; unexplained chronic fatigue; idiopathic chronic fatigue; and CFS, etc.

I've just been thinking that the idea of ME being a discrete disease might scare them intensely, so perhaps the use of wording might be important to consider carefully.

For example, it might be easier for them to warm to the idea of ME being a distinct 'subset', with distinct symptoms.
The word 'subset' might be more palatable for them. (Not necessarily a subset of CFS, but just a 'subset'.)

But I don't know... That might be too ambiguous and give them too much wriggle room.

In any case, this seems like a good time to present them with evidence that ME has very distinct symptoms and is not some vague fatiguing illness, and that fatigue is not even the most problematic symptom for many ME patients. And to discuss the significance of PEM and PENE.

And also inform them that Fukuda is the result of a compromise that tried to incorporate unexplained chronic fatigue symptoms with ME symptoms in a single set of criteria, leading to a meaningless fudge. That's where diagnostic criteria by committee gets you. (Nowhere.)

They need to either investigate unknown fatiguing illnesses on their own, or ME on it's own, or both separately.
And not mix them all up in a heterogeneous broth.

At the very least, ME has very distinct symptoms that should be investigated as such. And this is what the patient community want, and it's what the expert clinicians want.
 
alex3619

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
jspotila said:
The contracts page was updated this morning:



I have no idea what this means. I've got calls in to several federal offices looking for clarification. Details here as I get them: http://www.occupycfs.com/2013/09/04/dont-stop/
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We can hope so. Thank you for keeping us updated. :thumbsup:

My understanding is that Fukuda criteria were always intended as a broad definition but Fukuda himself wanted it broken down further into more distinct defintions over time, which never happened.
 
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I've sent a letter, asking for ME to be investigated as a distinct entity, or a distinct set of symptoms, and I set out some of the differences between CF, CFS and ME.
I explained why using external consultants new to the field would not result in an adequate process to get to grips with such a complex subject, where there are such subtle differences between different cohorts, explaining that most of the existing research literature is based on the muddled, inadequate and heterogeneous Fukuda definition, and will not enlighten a newcomer.
I also asked that expert clinicians who understand the subtle and complex differences between CF, CFS and ME, lead the project.
I also asked for patients to have a leading role in the project, pointing towards the FDA's stakeholders' meeting as a way to engage the community.
And I discussed some other related stuff, hopefully more articulately than this post! :cool:
 
B

Bob

Senior Member
Messages
16,455
Location
England (south coast)
I forgot to say... Thanks to everyone for taking such impressive action on this issue so quickly... Everybody's fast efforts seem to have made a difference already! (let's hope so anyway) The quality of the work posted on this forum, on Jennie's blog and on Cort's blog is really impressive, and I'm really grateful for it. All the contact details etc made sending in an email very easy. I don't usually get heavily involved in US advocacy, but this seems like an essential time to get stuck in!!!
 
Kati

Kati

Patient in training
Messages
5,497
I think HHS, CDC and NIH and possibly IOM needs to be forward thinking and include a patient representative (voted by the patient population) on EVERY committee they are forming regarding our health, disease definition and else.

"Nothing about me without me!"
 
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