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CFIDS Association asking expert signatories about their current position on endorsing the CCC

Nielk

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We do not have to go too far to "imagine" how IOM will select their panel. Just look into what they very recently did with GWI. If you want to make an informed opinion with how you want to stand on this, do some research on IOM. The only time they were tasked to define an illness is recently with GWI. They have decimated them. There was only one panel member with real experience with GWI whereas they had a few in a the "Behavior sciences".

In my opinion, after looking into this heavily, it would be suicide for us if this goes through. This is not a dress rehearsal. This is very serious. We can't just sit back and say "okay, let's just see what they will do. I am hoping for the best". Once it's done, it's done. It will be too late to change it.

Are we willing to take a chance that IOM will re-name ME/CFS with chronic malaise? Do we want them to give an official stamp to GET?CBT?

If like I, you are not willing to see that, then I would plead with you to contact your congressional representatives.
See instructions: http://forums.phoenixrising.me/inde...opt-the-ccc-cancel-the-iom.25473/#post-390297
 

WillowJ

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I asked Jennie Spotila if she had seen this and she responded on her blog:

http://www.occupycfs.com/2013/09/26/trust/#comment-39827

I have seen the actual letter Jeannette is talking about. It does not ask the signatories to change their position. It asks IF they have changed their minds after the IOM announcement. I do not know what the Association’s position is at this point.​
That said, the letter could have been more neutrally worded than it is. And it’s not surprising that one or more of the 35 signatories would share the letter with others given how volatile the situation is right now.​

jspotila - hope it's OK to repost that.

I think it's an important distinction and I think it's important to keep things accurate.

justinreilly, Kina - I think the title of this thread should be changed to 'CFIDS Association asking expert signatories about their position now on endorsing the CCC'.
If that's what the letter says, it could be asking whether they have changed their minds about asking for IOM to be removed from the equation entirely (since there is a process for adding actual experts, and since they will consider, among other things, CCC and ICC). There's no reason to assume it was about CCC. That letter covered a lot of ground.
 

Otis

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On to the topic at hand, I don't necessarily believe that the IOM is going to do a bad job. What worries me is not the IOM contract, but the lack of transparency in the decision making.
The HHS don't seem to want to empower the community (which involves being completely transparent, uniting and guiding the community to state their needs and recommendations and then taking action based on these recommendations). I don't want the HHS to 'withdraw' the contract, I just want them to start taking the community seriously. That includes consulting the community in depth when it comes to their final recommendations on case definitions.
I've got to disagree with this point of view. If the process that led up to the IOM contract lacked integrity then I have no confidence that the contract itself it will proceed with integrity. But you're the kind of optimist with whom I like to play poker. ;)

This has been discussed at length at the thread about the IOM contract itself.
 

Esther12

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The more I read about this, the more ominous the feeling I get.

I tend to avoid discussions about criteria, and tend to think it's more important that we try to focus all research on identifying meaningful sub-types, rather than spend lots of time researching the best criteria for lumping loads of patients together under a CFS-like label, but the way that they gone about things so far, and their Gulf War stuff, and what seems to be their plan for CFS all make me think that this is going to be bad for patients.

If this has been going on for some time, why haven't patients been kept fully informed on all deliberations?:

as the committee reviews the literature, efforts that have already been completed on this topic area will be considered, including the 2003 ME/CFS Canadian Consensus Definition, the 2007 NICE Clinical Guidelines for CFS/ME, the 2010 Revised Canadian ME/CFS definition, the 2011 ME International Consensus Criteria, and data from the ongoing CDC multi-site clinical study of CFS. In an effort to minimize overlap and maximize synergy, the committee will seek input from the NIH Evidence-based Methodology Workshop for ME/CFS.
http://www.research1st.com/2013/09/23/confirmation-iom/

lol at this:

HHS is proud to be making this investment in ME/CFS. We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email.
Trust that many have been addressed by this email? Really?
 

Firestormm

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4) IOM will likely employed an "evidence-based" process to come up with definitions/ treatment recommendations. The problem is in ME/CFS, we don't have enough evidence of the right types yet (e.g. a really good trial on pacing) to come to the right conclusions. With the "evidence" out there already, we will end up getting recommended GET/ CBT. This is what happened with the NICE Guidelines in the UK, which, unfortunately, our friends across the pond have had to deal with.
I do not wish to take away anything from what you say above, Justin, not in the least; and I know this is peoples overriding perception of NICE - though activity management does form a key part of the advice for patients as well as the whole 'personalisation' approach; AND let's not forget that these are guidelines. Yeah I know, the way things are going over here doctors seem more keen to be seen to follow religiously these things to the letter almost, when their first duty is to the best interests of the patient sat in front of them as an individual. I am hoping that you guys will be able to improve upon NICE. But it is a thorough document - and while I don't agree with all of it by any means - I think when compared to what else is out there: it will form a key part of the IOM review.

I don't know what form the review will take. I don't know if, for example, you and your representative organisations have the time to try and compile the equivalent to the CFS/ME Working Group Report to the Chief Medical Officer that occurred here in the UK in 2002 and formed a key part/key influence to the NICE Guideline. Indeed if you read the Guideline you will see it quotes from the Report verbatim. You guys need - I would suggest - to try and do something similar to that Report - if you are able to in the timeframe.

Incidentally, and I keep mentioning it but will do again, if you read Section 5 Diagnosis, from the Full Nice Guideline, from page 124 I think (download it online and then the index is interactive), you can see the criteria that were reviewed by the Guideline Development Group, as well as the testing before diagnosis, and their reasons for rejection, acceptance of them either in part or in whole. Just remember this was pre-2007. I guess the question really is - has anything changed to e.g. CCC since then which might increase it's appeal to IOM?

I am wondering, as I don't know what role really the IOM has in the US, if they weren't also called in to represent 'independence' given that one perception is that within the community of CFS/ME, there is little concord or agreement. Just a thought. Not that it means of course 'our worries are over' far from it. Time to gear up for action and I think put all the negativity behind - because whatever is decided it is better to try and be in the room and at least hope to be influential than to be left outside.
 

Firestormm

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We do not have to go too far to "imagine" how IOM will select their panel. Just look into what they very recently did with GWI. If you want to make an informed opinion with how you want to stand on this, do some research on IOM. The only time they were tasked to define an illness is recently with GWI. They have decimated them. There was only one panel member with real experience with GWI whereas they had a few in a the "Behavior sciences".

In my opinion, after looking into this heavily, it would be suicide for us if this goes through. This is not a dress rehearsal. This is very serious. We can't just sit back and say "okay, let's just see what they will do. I am hoping for the best". Once it's done, it's done. It will be too late to change it.

Are we willing to take a chance that IOM will re-name ME/CFS with chronic malaise? Do we want them to give an official stamp to GET?CBT?

If like I, you are not willing to see that, then I would plead with you to contact your congressional representatives.
See instructions: http://forums.phoenixrising.me/index.php?threads/tell-congress-to-listen-to-our-experts-adopt-the-ccc-cancel-the-iom.25473/#post-390297
Has anyone read the IOM report in question? Just wondering if it's worth me taking the time out to do so?

 

dannybex

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The primary point is this contract isn't needed and is a waste of money for doing something that isn't needed. $1 million to come up with a standard that is already in existance and has been used successfully. All HHS needs to do is direct CDC to stop using all those old, never-adequate definitions and adopt the CCC.
...
IF IOM is not as dishonest as HHS, it will immediately employ the 35 signers to do this job, let them finish it in 2-3 months and submit the results immediately and NOT WAIT for 18 months of our lives to be wasted on this diversion.
Well said. This isn't needed, period, and just seems like a transparent attempt to win some contract or grant, make some $$ during the process, while diverting monies that could be used to proceed with pertinent research and/or studies.

Shame on Vernon and Co...
 

WillowJ

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It looks to me like ME/CFS experts and patients will be treated as outsiders who will be allowed to make suggestions, but will not be involved in the actual process of working through the evidence and arriving at a conclusion.
I'm concerned about that, too. I'm also concerned that our experts and patients have not already been given a central and public role in all this.
 

Denise

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Firestormm, I have read the full report.
You might search for chronic fatigue syndrome within the text as well as the chapter on chronic fatigue syndrome.
Also read
The section on REVIEW OF TREATMENTS FOR COMORBID AND RELATED CONDITIONS
TABLE 5-3 Summary of Treatments Recommended in Guidelines or Found to be Effective in Systematic Reviews for Conditions Comorbid with and Related to Chronic Multisymptom Illness
Appendix B
I would say "enjoy" but it's not conducive to that.
 

Valentijn

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TABLE 5-3 Summary of Treatments Recommended in Guidelines or Found to be Effective in Systematic Reviews for Conditions Comorbid with and Related to Chronic Multisymptom Illness
Appendix B
I would say "enjoy" but it's not conducive to that.
The table is on page 120-122. Basically we can have NSAIDs, melatonin, and anti-depressants. CBT and GET are recommended, as well as life-style changes, CPAP, and yoga/tai chi/massage/acupuncture.

It's fascinating really. There are 13 co-morbid conditions listed, and CBT is the treatment for everything except functional dyspepsia ("functional" usually = "psychosomatic"). Oh wait. In the actual Functional Dyspepsia section they do recommend anti-depressants and CBT. :rolleyes:

These people are one huge quackfest. I don't think it's even a question of "how do we know what approach they'll take?" They will take the psychosomatic/deconditioning/blame the patient/boom and bust/CBT/GET approach. And that's exactly what HHS wants from them.
 

Sasha

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Received from Mary Dimmock via Co-Cure:

Below is an excellent letter sent by Dr. Lily Chu to Secretary Sebelius in support of the letter from 35 leading researchers and clinicians calling for the adoption of the Canadian Consensus Criteria and urging HHS to abandon the IOM contract. Dr. Chu is a physician and an ME patient. Dr. Chu has given permission for this letter to be shared publicly. It can be found online here - http://bit.ly/1bhJznQ

Dear Secretary Sebelius, Dr. Koh, Dr. Maier, Dr. Unger, Dr. Lee, Dr. Fineberg, and Dr. Behney,

As a physician, health services researcher, and person affected by myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS), I am writing to you today to request that you consider strongly the letter expert ME/CFS scientists and physicians sent September 23, 2013 and cancel the Department of Health and Human Services’ contract with the Institute of Medicine (IOM) to construct a clinical case definition for ME/CFS. While I am appreciative of DHHS’ continued interest in ME/CFS and recognize the important and influential role the IOM plays in the health of the nation, I believe that the money and resources spent on such a contract might not only be duplicative and better spent on other areas of ME/CFS research but may end up being harmful to patients in the short-term, by subjecting them to inappropriate treatments, and in the long-term, by obstructing and obscuring research progress. Patients, patient advocates, clinicians, and researchers
understand these issues and thus, rather than greeting the contract with joy and enthusiasm expected, are instead contacting you with their concerns.

Duplicative efforts will waste time, resources, and money

1) Over the decades, a number of different clinical case definitions from different countries have been proposed for ME/CFS. Expert clinicians and researchers have reviewed all of them, found many to be unsatisfactory in describing patients, and, thus, came up with two different consensus-based definitions in the last decade, the Canadian Consensus Criteria (CCC, 2003) and the Myalgic Encephalomyelitis - International Consensus Criteria (ME-ICC, 2011). The experts recognize that both the CCC and ME-ICC need further validation and refinement but agree that these definitions are adequate enough to be used NOW both for clinical and research purposes. Indeed, use of the CCC has already yielded a possible treatment, rituximab, for some patients via a successful small trial in Norway.

2) DHHS’ own CFS Advisory Committee (CFSAC), recommended in October 2012 that “at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) experts, patients, advocates) workshop in consultation with CFSAC members [be convened] 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.” CFSAC did not ask for separate meetings to construct separate clinical and research definitions but for meetings to construct a case definition useful for multiple purposes.

3) Several studies, including the Centers for Disease Control and Prevention’s Multi-Site Clinical Assessment Study, and a meeting, an Evidence-based Methodology Workshop, are already being planned by the National Institutes of Health to address the issue of case definitions. It is unclear how IOM involvement would add value to the processes already underway. Instead too many cooks may spoil the broth.

4) Whenever patients, clinicians, researchers, advocates, or CFSAC have asked for increased funds for ME/CFS research and care, like for a Request for Applications (RFA) or for a Center of Excellence, they are told that there is no money. Yet, DHHS has money now to spend on a meeting rather than these repeated worthwhile requests?

Separate research/ clinical case definitions are harmful to patients, obstructive/ destructive to research efforts

The last 3 decades have demonstrated that the separation of clinical care and research has resulted in suboptimal, even harmful care, of patients and little progress in our understanding of the cause(s) of and treatment for ME/CFS.

As shown recently by the US Food and Drug Administration’s excellent final report from their ME/CFS Drug Development Workshop (The Voice of the Patient), post-exertional malaise (PEM), exacerbation of all ME/CFS symptoms (including pain, exhaustion, sore throat, insomnia, cognitive problems, etc.) with mild physical/ cognitive activity, is a key feature and disabling symptom of ME/CFS. PEM, not chronic fatigue, is why patients are bedridden, homebound, unemployed, and unable to walk a block. Clinicians from around the globe who see and take care of thousands of ME/CFS patients regularly are well aware of this symptom and thus chose it as a required symptom when constructing both the CCC and ME-ICC. The management of PEM is also different from chronic fatigue; rather than push patients to ignore PEM and to continue to engage in mental or physical activity, which could result in not only temporary but prolonged disability, experienced clinicians tell
patients to balance their activity with rest to decrease the onset or severity of PEM.

In contrast, the emphasis on fatigue by the 1994 Fukuda and other case definitions promote the image of ME/CFS as a benign illness that can be overcome merely by a positive attitude, increased exercise, healthy diet, and enough sleep. This is reinforced by European-based clinical trials of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) that claim to substantially improve the health of or even cure ME/CFS patients. These are double-blind randomized placebo-controlled clinical trials so they must be the best and last word in care, right? This treatment information is distributed widely in usually trusted resources such as the online medical database UpToDate. Yet a careful reading of those trials shows that frequently, subjects were selected primarily because of chronic fatigue and that a common primary outcome measure was fatigue reduction. PEM was neither required for subject selection nor measured as an outcome. (Aside from the
fact that none of the trials report objective increases in activity, for example, via actigraphy.)

Consequently, when the results of those trials are applied in practice to patients with symptoms beyond only chronic fatigue, over 50% of thousands of patients surveyed over the last decade have stated that those treatments made them worse, not better. Patients who follow their physicians’ directions faithfully have ended up bedridden, some for days, others for years. The most recent IOM contract announcement mentions the 2007 NICE Guidelines for CFS/ME from the United Kingdom, where CBT and GET are mainstays of treatment. The NICE guidelines were not deemed to be “nice” but rather “unfit for purpose” by the ME Association and UK patients, who asked for a judicial review of that document. When the majority of people receiving a treatment are not getting better or even getting worse, we should ask WHY, not cling to the results of trials and doubt the words and experiences of patients.

Because most physicians are not educated about PEM and the limits of GET/ CBT trials, patients who do not improve substantially with or defer CBT or GET are either blamed for non-compliance or viewed as depressed, malingerers, or hypochondriacs. In 2011, the Centers for Disease Control and Prevention reported that 85% of clinicians still viewed ME/CFS as a wholly (14%) or partially psychiatric disorder (71%). A quarter of clinicians recommended referral to a psychologist as an initial treatment. This perception, coupled with lack of knowledge, is why hundreds of thousands of patients all over the United States cannot find a single knowledgeable and sympathetic physician to take care of them. It doesn’t matter if the patient visits Dr. “Average” at a rural private practice clinic or Dr. “Expert” at a metropolitan internationally respected university medical center. The attitude displayed and advice given is rarely different; when choosing
“experts”, even those selected for their methodological/ analytic rather than clinical/ basic science skills, will DHHS or IOM consider screening for knowledge about or attitudes towards ME/CFS? Will those who view it as a primarily psychological or psychiatric illness be screened out? I understand that the current IOM Gulf War Illness panel is currently facing criticism from Gulf War veterans and even from the chairman of the GWI advisory committee, Jim Binns, that the panel includes members who don't think GWI is a physical illness. Will any ME/CFS IOM committee have the same problem?

This history is largely why I and other patients, now joined by expert clinicians and researchers, experience a collective shudder of fear and horror when they hear DHHS plans to a) construct a clinical case definition employing professionals unfamiliar with ME/CFS, b) separate from a research case definition, c) at several separate meetings no less. ME/CFS’s past is filled with examples of ineffective and harmful ideas and treatments visited upon patients without listening to their stories nor to those of the clinicians taking care of them. Confusion and harm has already been incurred by applying research based on one definition (e.g. Oxford-based PACE trials) to patients diagnosed with another definition (Fukuda) and by employing a research case definition (Fukuda), without a solid clinical grounding, that focuses on the wrong symptom. Why make that same mistake again?

We now have two case definitions, CCC and ME-ICC, vetted by experienced clinicians that are already being used in both practice and research. I see no need to waste further time, money, or energy on another consensus-based meeting when those resources could be better used to validate/ refine these definitions or find biomarkers, diagnostic tests, or treatments. Patients’ lives are passing by each minute, never to be regained; don’t make us to wait another 3 decades!

Thank you for your attention,
Lily Chu, MD, MSHS,
Burlingame, CA
 

Tom Kindlon

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Received from Mary Dimmock via Co-Cure:

Below is an excellent letter sent by Dr. Lily Chu to Secretary Sebelius in support of the letter from 35 leading researchers and clinicians calling for the adoption of the Canadian Consensus Criteria and urging HHS to abandon the IOM contract. Dr. Chu is a physician and an ME patient. Dr. Chu has given permission for this letter to be shared publicly. It can be found online here - http://bit.ly/1bhJznQ

<snip>

In contrast, the emphasis on fatigue by the 1994 Fukuda and other case definitions promote the image of ME/CFS as a benign illness that can be overcome merely by a positive attitude, increased exercise, healthy diet, and enough sleep. This is reinforced by European-based clinical trials of cognitive behavioral therapy (CBT) and graded exercise therapy (GET) that claim to substantially improve the health of or even cure ME/CFS patients. These are double-blind randomized placebo-controlled clinical trials so they must be the best and last word in care, right? This treatment information is distributed widely in usually trusted resources such as the online medical database UpToDate. Yet a careful reading of those trials shows that frequently, subjects were selected primarily because of chronic fatigue and that a common primary outcome measure was fatigue reduction. PEM was neither required for subject selection nor measured as an outcome. (Aside from the
fact that none of the trials report objective increases in activity, for example, via actigraphy.)

Consequently, when the results of those trials are applied in practice to patients with symptoms beyond only chronic fatigue, over 50% of thousands of patients surveyed over the last decade have stated that those treatments made them worse, not better. Patients who follow their physicians’ directions faithfully have ended up bedridden, some for days, others for years. The most recent IOM contract announcement mentions the 2007 NICE Guidelines for CFS/ME from the United Kingdom, where CBT and GET are mainstays of treatment. The NICE guidelines were not deemed to be “nice” but rather “unfit for purpose” by the ME Association and UK patients, who asked for a judicial review of that document. When the majority of people receiving a treatment are not getting better or even getting worse, we should ask WHY, not cling to the results of trials and doubt the words and experiences of patients.

Because most physicians are not educated about PEM and the limits of GET/ CBT trials, patients who do not improve substantially with or defer CBT or GET are either blamed for non-compliance or viewed as depressed, malingerers, or hypochondriacs. In 2011, the Centers for Disease Control and Prevention reported that 85% of clinicians still viewed ME/CFS as a wholly (14%) or partially psychiatric disorder (71%). A quarter of clinicians recommended referral to a psychologist as an initial treatment. This perception, coupled with lack of knowledge, is why hundreds of thousands of patients all over the United States cannot find a single knowledgeable and sympathetic physician to take care of them. It doesn’t matter if the patient visits Dr. “Average” at a rural private practice clinic or Dr. “Expert” at a metropolitan internationally respected university medical center. The attitude displayed and advice given is rarely different; when choosing
“experts”, even those selected for their methodological/ analytic rather than clinical/ basic science skills, will DHHS or IOM consider screening for knowledge about or attitudes towards ME/CFS? Will those who view it as a primarily psychological or psychiatric illness be screened out? I understand that the current IOM Gulf War Illness panel is currently facing criticism from Gulf War veterans and even from the chairman of the GWI advisory committee, Jim Binns, that the panel includes members who don't think GWI is a physical illness. Will any ME/CFS IOM committee have the same problem?

This history is largely why I and other patients, now joined by expert clinicians and researchers, experience a collective shudder of fear and horror when they hear DHHS plans to a) construct a clinical case definition employing professionals unfamiliar with ME/CFS, b) separate from a research case definition, c) at several separate meetings no less. ME/CFS’s past is filled with examples of ineffective and harmful ideas and treatments visited upon patients without listening to their stories nor to those of the clinicians taking care of them. Confusion and harm has already been incurred by applying research based on one definition (e.g. Oxford-based PACE trials) to patients diagnosed with another definition (Fukuda) and by employing a research case definition (Fukuda), without a solid clinical grounding, that focuses on the wrong symptom. Why make that same mistake again?

We now have two case definitions, CCC and ME-ICC, vetted by experienced clinicians that are already being used in both practice and research. I see no need to waste further time, money, or energy on another consensus-based meeting when those resources could be better used to validate/ refine these definitions or find biomarkers, diagnostic tests, or treatments. Patients’ lives are passing by each minute, never to be regained; don’t make us to wait another 3 decades!

Thank you for your attention,
Lily Chu, MD, MSHS,
Burlingame, CA
In case people haven't come across Lily's name before, among other things she gave the most help to me with the paper:

Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Bulletin of the IACFS/ME. 2011;19(2):59-111
http://iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/tabid/501/Default.aspx
as I acknowledged:

Acknowledgements:

I would like to thank Lily Chu, MD, MSHS for her invaluable assistance. I would also like to thank the reviewers and the many people who gave comments on earlier drafts of the paper. This paper is dedicated to the memory of Amberlin Wu, who helped proofread the first draft.
The paper can be used to reference this point she makes:
Consequently, when the results of those trials are applied in practice to patients with symptoms beyond only chronic fatigue, over 50% of thousands of patients surveyed over the last decade have stated that those treatments made them worse, not better.
I have been very impressed with my dealings with her. As well as everything else, she is very bright and educated and I think is a valuable asset to the ME/CFS community.
 

Andrew

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Among other things, Dr. Chu did an excellent job of explaining how/why the UK and similar research misses the point.

And now that I'm pondering this more, I realize how very easy it is for researchers to confuse post-exertion malaise/post-exertion symptom exacerbation (PEM/PESA) with fatigue. In fact, this is my personal experience with doctors. I can explain to them exactly how I experience PEM/PESA and in their minds they substitute the concept of "fatigue." Probably because that's what they experience after activity.