Talking with CFSAC – Views from the other side of the table

August 19, 2013

Gabby (Nielk) looks at the background to The Chronic Fatigue Syndrome Advisory Committee (CFSAC) and interviews 5 members including the Chairman…

cfsac_members - August 2013

 “Any committee is only as good as the most knowledgeable, determined and vigorous person on it. There must be somebody who provides the flame.” Lady Bird Johnson

The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services.

We are fortunate that The Chronic Fatigue Syndrome Advisory Committee (CFSAC) is one of ten advisory committees assigned by HHS. The Committee provides us with a great opportunity to bring awareness to the government and to the public of the reality, scope and severity of this illness. In turn, the Committee is charged to bring advice and recommendations to the Secretary of Health on issues pertaining to ME/CFS.

As a patient community we have been giving the meetings, proceedings and accomplishments our full attention, and the successful function of the Committee is vital to our future. Some of us have personally attended the meetings, others have submitted written and/or oral testimonies. We have given our opinions, but what about the opinions of the members?  The members who serve on CFSAC have taken time out of their busy schedules and careers in order to be of service by using their expertise to advise the government on how best to improve the plight of ME/CFS patients.  This is a great responsibility. What is it like for them, sitting at the other side of the table?  What brought them there and what are their personal thoughts?

Background information

CFSAC – formerly known as the Chronic Fatigue Syndrome Coordinating Committee – was established by the Secretary of Health and Human Services on September 5, 2002. Its purpose includes advising and providing recommendations to the Secretary of Health and Human Services, through the Office of the Assistant Secretary for Health (ASH), on issues related to research, access and care for individuals with ME/CFS.

The committee membership is comprised in part by eleven voting members, including the Chair. Seven of these appointees are biomedical researchers with demonstrated expertise in biomedical research applicable to CFS and four are disability or clinical care experts and/or patient advocates 

Each public appointee to the Committee serves for a limited term of up to four years. The eleven members of the public are appointed by the Secretary for Health according to the Federal Advisory Committee Act (FACA). All members are classified as Special Government Employees (SGE). 

The Committee also includes seven non-voting ex officio members. They include representatives of the following government agencies: Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention (CDC); Center for Medicare and Medicaid Services (CMS); Food and Drug Administration (FDA); Health Resources and Services Administration (HRSA); National Institutes of Health (NIH); Social Security Administration (SSA).

ME/CFS community representation

In 2013 committee membership was extended to include three non-voting liaison organizations from the ME/CFS community. They will each serve a term of two years. The organizations and their respective representatives at present are:

CFIDS Association of America – Leigh Reynolds

International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME) – Dr. Fred Friedberg

New Jersey Chronic Fatigue Syndrome Association, Inc. (NJCFSA) – Dr. Kenneth Friedman

In its ten year history, thirty-four voting members have served on CFSAC.  The committee has introduced a total of seventy-seven recommendations, attending twenty-four public meetings (yes, I like math!). The list of voting members have included some well known names in the ME/CFS community such as: Dr. Lucinda Bateman, Dr. David Bell, Dr. Leonard Jason, Dr. Nancy Klimas, Dr. Anthony Komaroff, Dr. Charles Lapp and Dr. Christopher Snell. 

Interviewing the Committee members

Dr. Gailen Marshall

Committee Chair: term –  5/10/10 to 5/10/14                                

What personal connections and/or experiences with ME/CFS led you to serve on CFSAC?

As a young Immunology faculty member in Texas in the early 1990s, I was approached by a colleague who asked me to do an immune workup on a patient whose chief complaint was the sudden onset of debilitating fatigue with cognitive dysfunction and Post-Exertional Malaise. She was subsequently diagnosed with Chronic Fatigue and Immune Dysfunction Syndrome.

This began my almost 20 year interest in seeing patients with this illness and participating in research projects with Dr. Ron Glaser and others looking for evidence of latent virus reaction in CFIDS patients. When I was approached by Dr Glaser in 2010 to consider being nominated to serve on CFSAC, I had not seen patients with this illness in almost 10 years since moving to Mississippi from Texas.

After considering the purpose of CFSAC, I could not say no – many of my patients from the early days of my career had stuck in my mind – and the frustration of not being able to provide definitive care had continued to bother me. I reasoned that by serving on CFSAC I might be able to somehow contribute to finding the causes and helping to better understand the scientific basis for more effective treatments.

Implementing a name change and establishing appropriate diagnostic criteria were the issues discussed at the inaugural meeting in 2003.  These are the same issues that are on the table today, 10 years later. In your opinion, what actions need to be taken to finally achieve these changes?

I empathize with those who passionately believe the name of this illness needs to be changed. I still vividly remember some of my colleagues in Texas “rolling their eyes” when they found out I was caring for patients with CFIDS (the name at the time). Even in those early days (for me), I noticed the spectrum of symptoms and responses (or lack thereof) to treatment which made it difficult to put all the patients neatly into a single diagnostic category.

As medicine has progressed over the past 30 years, the heterogeneity of many diseases has become increasingly apparent due to better understanding by clinicians and researchers alike. This addresses the concern I have about a name change for CFS at this particular point in time. There are several names which have been suggested as replacements  – the most vocalized one I have heard and read about is myalgic encephalomyelitis (ME). While this name may well describe many patients with the illness heretofore called CFS, it by no means describes everyone.

Is this because some patients may have an overlap with other neuro-endocrine-immune disorders? Is it because we do not yet know how to discern whether the differences in clinical presentations are because of individual differences in such things as pain tolerance levels, functionality etc.? Or whether they may represent different subtypes, or even different illnesses, under the current rubric of CFS? That is why I am in favor of moving carefully on a name change once we better understand the commonalities and heterogeneity in clinical characteristics and pathophysiology of this illness.    

In general, are you satisfied with the responses to CFSAC’s recommendations from the Secretary of Health and Human Services?

I can only speak for the time I have served in the CFSAC (since June 2010). I have found the Secretary’s Office, beginning with Dr Howard Koh and the DFOs, first Dr Wanda Jones followed by Dr Nancy Lee, and their staff to be dedicated to helping us in getting our recommendations to the Secretary for her consideration.

Recently, Drs Koh and Lee are providing extremely valuable advice to  us about reformatting how CFSAC does its recommendations to come more in line with other DHHS advisory committees, so that our recommendations have more evidence provided to the Secretary to support them. Further Drs Koh and Lee are proving more specific direction to us for what sort of information is necessary to effectively support our recommendation. This has resulted in the formation of working groups within the Committee tasked with answering specific questions and gathering evidence to support the crafting of specific recommendations to present to the Secretary for her consideration.

I believe this will increase the effectiveness of our task – advising the Secretary on how to use her office’s influence and/or resources to improve the lives of patients with ME/CFS through more effective education, research and patient care.

What have been your greatest challenges and/or frustrations from serving on this Committee?

I suppose I would have to say that the greatest challenge and resulting frustration is that there is not enough time to hear every single person who has something to say about this illness, whether it be the patients themselves, their families, advocates, scientists or clinicians who want to help. The lack of any definitive therapy for this illness is equally frustrating since we as a committee can only provide advice and recommendations: we cannot implement anything on our own.

In what way can ME/CFS patients be useful in assisting the Committee in order to achieve its most important functions?

As we transition to the new approach to gathering information and making recommendations that we hope result in more rapid action by the Secretary’s office, patients can help us by remembering that, to a person, the members of CFSAC do what we do to try and help you, the patients. There are no hidden agendas for any of us. Help us understand your perspective, share with us your thoughts on what we are doing but (and I understand the difficulty in this statement) be patient with us.

The progress we have made over the last 18 months is extremely encouraging yet it has not yet produced a new effective therapy or a new social policy to assist patients and their families or even a firm educational venue to increase the number of interested providers with expertise to care for ME/CFS patients more effectively. But I truly and passionately believe that these are coming. We ask for your support and your prayers: just as you have ours.

Levinev2 - August 2013

Dr. Susan Levine

Voting member - Term 05/10/10 to 05/10/04

What personal connections and/or experiences with ME/CFS led you to serve on CFSAC?

CFS/ME has been my field of concentration for more than 2 decades now. I’ve always felt since I saw my first patient in an Infectious Disease Clinic while doing my Fellowship at Memorial Sloan Kettering in NYC; that the illness was ‘real’ and that it took a heavy toll on people’s lives even though back then there was even less information and very few biomarkers available.  

I guess over the years I’ve been struck by the substantial lack of support in the medical community and in some cases, hostility in my immediate medical community, towards acknowledging its existence; although that has changed a little. I found that my NY colleagues are willing to identify their patients who suffer from CFS/ME or at least make a tentative diagnosis but then don’t want to deal with it from there.

Documentation of disability on their part is practically nonexistent so that has been a challenge for my many patients requiring significant documentation for their illness. In any case one of my major missions over the years has been to try to reach out to those medical colleagues who don’t know anything about CFS/ME.  

It is the case that at a lot of these conferences about CFS/ME, the same interested parties and familiar faces return, but I truly want to ‘hook’ the doctors who are on the periphery, and engage them in learning more about this condition and to take an interest in helping their patients; even if it is only in guiding them to the appropriate specialist.

I guess I had hoped that in serving on CFSAC I could help to get the word out there some more and I’m trying to do that in my ‘Education Working Group’.

Implementing a name change and establishing appropriate diagnostic criteria were the issues discussed at the inaugural meeting in 2003. These are the same issues that are on the table today, 10 years later. In your opinion, what actions need to be taken to finally achieve these changes?

I do believe a name change is very important and don’t know how we can decide on what name is appropriate. Obviously ‘CFS’ doesn’t embody all the significant symptoms – neurological, musculoskeletal, viral and autonomic – that the condition causes. CFS/ME is a small step up but we need to do better!

I think CFSAC needs to decide to convene a workshop where we, as committee members and experts in this illness, can recommend to the Secretary and have her adopt the latest Canadian Clinical Criteria from the new manual; as the most accurate diagnostic paradigm for this condition that we have so far.  

It needs to be reworked as new scientific discoveries involving this condition are made. I suspect that there will be different definitions that researchers will adopt versus clinicians but we should discard the old Oxford criteria since it isn’t helpful. 

In general, are you satisfied with the responses to CFSAC’s recommendations from the Secretary of Health and Human Services?

We have not had any ‘responses’ per se from the Secretary. It would be nice to get some feedback.  

What have been your greatest challenges and/or frustrations from serving on this Committee?

The greatest challenge for me has been feeling like we spend enough time on these major policy issues, only meeting twice a year. I wish we could hold more frequent – even phone – meetings, and I wish that we could engage more of the national and international medical community and obtain their feedback.

In what way can ME/CFS patients be useful in assisting the Committee in order to achieve its most important functions?

I think the advocates are already doing a great job and giving tirelessly of their time, limited energy and financial resources. I’m absolutely moved to tears with everyone’s testimony and wish that we were closer to finding relief for everyone!

Dr. Kenneth Friedman

Non-voting member representing New Jersey Chronic Fatigue Syndrome Association, Inc. (NJCFSA) 

(Dr Friedman previously served from 2003 to 2007)

What personal connections and/or experiences with ME/CFS led you to serve on CFSAC?

As most members of the ME/CFS Community know, my daughter became ill with ME/CFS due to the inability of a college health service to properly diagnose and treat her mononucleosis. 

As a medical school professor, I felt that I was in a unique position to rectify her problem. Sadly, I was to learn, that my intuition and abilities fell far short of the mark. In an effort to help her, and to help those similarly afflicted, I started a one-man campaign to research and resolve ME/CFS, as well as to overcome the profound ignorance of, and prejudice against, ME/CFS disturbingly present amongst my medical school colleagues. 

I saw the opportunity to serve on the CFSAC as an opportunity to bring my unique experiences as the father of an ME/CFS patient, and as a medical school professor, researcher, author, and educator to the national seat of power; whereat these experiences could be channeled into national policy that would benefit a segment of the U.S. population so besieged by illness that they could not advocate successfully on their own. 

Implementing a name change and establishing appropriate diagnostic criteria were the issues discussed at the inaugural meeting in 2003. These are the same issues that are on the table today, 10 years later. In your opinion, what actions need to be taken to finally achieve these changes? 

I have always maintained that the name of this illness should be changed but that the name needs to be reflective of the pathophysiology of the illness. The condition bears many similarities to HIV-AIDS but to call the illness non-HIV AIDS, probably creates as many problems as it potentially solves. 

Many years ago, we characterized CFS as a neuro-endocrine-immune disorder because these are the organ systems usually affected. At the current time Neuro Endocrine Immune Dysfunction would be my personal choice of new names for ME/CFS.

While some may argue, I would say that the Stevens’ Protocol, which uses two-day CPET (CardioPulmonary Exercise Testing), is an effective way to diagnose ME/CFS. I view the Stevens’ Protocol as the first scientifically and physiologically valid method of diagnosing ME/CFS.

Both a more precise name for the illness, and physiologically valid biomarkers of the illness will come with a better understanding of the pathophysiology of this illness.

In general, are you satisfied with the responses to CFSAC’s recommendations from the Secretary of Health and Human Services?   

I do not consider the verbiage put forward by the DHHS, provoked by the CFSAC recommendations, ‘responses’.  Recommendations are either accepted or not. It is that simple.

What have been your greatest challenges and/or frustrations from serving on this Committee?

The CFSAC should be permitted to do its work. The CFSAC should set its own agenda and be permitted to follow it. The role of the Designated Federal Officer is to assist the Committee in performing its work. It is not the role of the DFO to set the agenda or interfere with the Committee’s work and/or attempt to alter it.

In what way can ME/CFS patients be useful in assisting the committee in order to achieve its most important functions?

It would be useful if ME/CFS patients could support the Committee and its members. From my viewpoint, the Committee was most effective when large numbers of patients were in the audience at the CFSAC meetings and exhibited some signs of militancy. It was clear that the DHHS did not want patient demonstrations and seemed more willing to negotiate agenda items when failing to acquiesce to CFSAC recommendations might possibly result in patients demonstrating their disapproval.

Leigh Reynolds

Non-voting member representing CFIDS Association of America (replacing Kim McLeary)

What personal connections and/or experiences with ME/CFS led you to serve on CFSAC?

I do not have a personal history with ME/CFS – in fact, I was a little embarrassed to learn how little I knew when I began with the CFIDS Association this past January.

I do, however, have 20 years of experience in non-profit communications, patient involvement, marketing, management and fundraising. This career path is what led me to the CFIDS Association and ultimately the CFSAC.

I am honored and humbled to represent such a dedicated, passionate and engaged patient community. Though the CFIDS Association has been invited to serve as a non-voting member, I am hopeful that my past experience with MS, Polycystic Kidney Disease, Myasthenia Gravis, pediatric cancer and others can benefit the committee. I’d like to see us all work together to mobilize a focused, strong and powerful voice for change in ME/CFS.

Implementing a name change and establishing appropriate diagnostic criteria were the issues discussed at the inaugural meeting in 2003.  These are the same issues that are on the table today, 10 years later. In your opinion, what actions need to be taken to finally achieve these changes?

Because I am new to the cause and the ME/CFS community, I can’t speak effectively to what has or has not been done over the past decade, I can only speak through the lens of my limited experience having attended one CFSAC meeting, colored by my experience in the field with other conditions…

I believe that the ME/CFS patient community needs to come together and learn to speak clearly, concisely and professionally with one voice. We must work together to establish clear priorities rooted in solid science and policy, then effectively coach, train and mobilize all ME/CFS patients to effectively advocate for the agreed upon change.

Through tools and technology available today, that were not available 10 years ago (Facebook, YouTube, blogging, etc.), we have a greater opportunity to rally the ME/CFS community at large. If we can learn to speak as one, advocate together, involving a far greater number of those affected by this condition – those with ME/CFS and the people that love them – then we become a force to be reckoned with.

What have been your greatest challenges and/or frustrations from serving on this committee?

I am new to the Committee, attending in the public gallery at the last session. The next meeting in October will be my first to serve in any official capacity, so I can’t speak to challenges or frustrations serving, but I will offer this… Regardless of the challenges that I have heard about, I have never seen nor heard of a federal committee such as this. Despite hurdles involved, it is a tremendous opportunity.

Those  charged with staffing the Committee wear many hats, and the machinery in which they work is far too cumbersome, but they are a voice for so many – too many – who are too ill to speak for themselves and their service is a privilege. They would do well to remember that. 

It is beholden upon the patient advocacy groups and patients at large to do all they can to fully understand the complexity under which this Committee functions. We must recognize the situation the committee members work within and assume their positive intent; then work together to maximize progress within the current system. Where we see a need for change, we must professionally and effectively advocate for change.

In what way can ME/CFS patients be useful in assisting the Committee in order to achieve its most important functions?

Patients are our greatest asset in the fight for change. The more that patients stay engaged, educated and involved, the better. Critical to this effort are clear priorities, a cleanly defined path to progress, and speaking in one voice as much as possible. Imagine if in October, at the next CFSAC meeting, instead of putting forth several pages of recommendations, hearing public testimony on all varieties of issue and opinions, covering a multitude of topics; we came forward as one united patient community, articulating two key priorities… Not 4, or 12, or 17. Just two.

Each person speaking could add their own personality, flavor, experience and voice, but the core message would be spoken loudly and clearly. “We are here as ONE patient community, speaking to these TWO top priorities. We bring focus, commitment and passion; we are speaking intelligently, articulately and resolutely. We have put any and all differences aside because we know that we are too few to be divided. We know we are stronger when we act as one.”

In order to do this, we – the patient advocacy, action and research groups – must first do our work to come to the table, roll up our sleeves and do the hard work of finding consensus. Then we must educate and empower ME/CFS patients and their loved-ones to be able to join us and raise their voices for change.

Dr Fred Friedberg

Dr. Fred Friedberg

Non-voting member representing International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (IACFS/ME)

What personal connections and/or experiences with ME/CFS led you to serve on CFSAC?

I represent the IACFS/ME on the CFSAC. I believe that such organizational representation is important to have a full airing of views relevant to the agenda of these meetings.

Implementing a name change and establishing appropriate diagnostic criteria were the issues discussed at the inaugural meeting in 2003.  These are the same issues that are on the table today, 10 years later. In your opinion, what actions need to be taken to finally achieve these changes?

Well-designed studies that compare and contrast CFS/ME case definitions. This will potentially lead to a validated case definition that is more likely to identify biomedical factors. Without these studies, the science will be hindered.

In what way can ME/CFS patients be useful in assisting the Committee in order to achieve its most important functions?

Broad support for (1) advancing the science and (2) new dedicated funding initiatives from NIH (e.g. Request For Applications).

“I appreciate and am grateful to the members who have taken time from their busy schedules in order to take part in this interview, and I would like to commend them for their great work serving on CFSAC.”Gabby (Nielk)

Support Phoenix Rising

Phoenix Rising is a registered 501 c.(3) non profit.  We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we’d love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

And don’t forget: you can always support our efforts at no cost to yourself as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.

donate

68 comments

{ 68 comments… read them below or add one }

Sasha August 19, 2013 at 2:27 pm

Excellent interview, Gabby – really well-chosen questions.

I particularly liked this from Leigh Reynolds (because I have suggested something similar in the past!):

Patients are our greatest asset in the fight for change. The more that patients stay engaged, educated and involved, the better. Critical to this effort are clear priorities, a cleanly defined path to progress, and speaking in one voice as much as possible. Imagine if in October, at the next CFSAC meeting, instead of putting forth several pages of recommendations, hearing public testimony on all varieties of issue and opinions, covering a multitude of topics; we came forward as one united patient community, articulating two key priorities… Not 4, or 12, or 17. Just two.

Each person speaking could add their own personality, flavor, experience and voice, but the core message would be spoken loudly and clearly. “We are here as ONE patient community, speaking to these TWO top priorities. We bring focus, commitment and passion; we are speaking intelligently, articulately and resolutely. We have put any and all differences aside because we know that we are too few to be divided. We know we are stronger when we act as one.”

I have very mixed feelings about having patient testimony that is about the effects of being ill with ME. I feel that at this point, it should be a given that committee members understand how appalling it is. If they don't, I wonder whether there's a way of informing them that doesn't require patients to phone up/sit there and tell them and yet still gets the message across powerfully, such as a video presentation – perhaps a screening of Voices from the Shadows, or something. It seems to me that that meeting shouldn't need testimony to give committee members an understanding of the illness. If that committee were about MS or cancer, would people with those diseases be expected to call in to explain how horrible the diseases were? I doubt it. I have the greatest respect and admiration for those patients who've given this kind of testimony in the past – I don't think I'd have the emotional strength – but I think that the committee should be well past the point of needing that now. I think we need to move on from that stage and into focused advocacy.

I'd like to see patient after patient after patient slamming home the same agreed two or three points in testimony after testimony – ramming those points home. Doing the prioritisation for the committee, not leaving it up to them.

The difficulty I see is in finding and contacting those patients who have testimony slots – or perhaps forming the agenda and then seeking volunteers to take those slots and push that agenda. But I think it's very, very well worth doing.

Sasha August 19, 2013 at 3:22 pm

Actually, I'd add to my point above about the testimony that if anyone on that committee doesn't realise that ME is a serious disease then I don't know what they're doing there in the first place.

I think we've all seen various committees where committee members have been in tears following some moving testimony about patients' experience of the illness, only to see the committee then proceed to be utterly ineffectual in focusing on priorities and moving things forward. I think it would be more valuable to skip that kind of testimony, take it as read that the committee understand that they have a job to do, and help them do that job.

Sasha August 19, 2013 at 4:56 pm

I thought Dr Friedman's suggestion about a name change was interesting:

At the current time Neuro Endocrine Immune Dysfunction would be my personal choice of new names for ME/CFS.

I've not seen that suggestion before. It seems a good one because it describes the systems affected (and the ones that I think you have to have under the CCC to get a diagnosis) rather than mechanism and it's certainly light-years ahead of 'chronic fatigue syndrome'.

I don't know if there are other NEI disorders that it would need distinguishing from but it seems at least a good basis for a name. It would be good to leave all the ME vs CFS controversy behind, which has been so divisive, and start out with a new name. And then as subgroups are split off they can each be given their own name, according to their own characteristics.

Otis August 19, 2013 at 5:19 pm

Looks like we mostly disagree Sasha.

Dr. Marshall gave a politician's set of answers that are typical for the chair of this committee. I like the man but he isn't a leader or an organizer. I think the biggest required change is that the committee needs to lead and show some nerve to call out the Dr. Kohs of the world for not supporting the committee and the patients. What are they going to do? Fire you? Cut off the non-existent funding? It seems that to serve on the committee one must drink the "we can only do so much" koolaid and sign in blood to not rock the boat. BS, if you're there for the patients show some passion instead of behaving like you are just glad to be there and that your hands are tied. If you want a show of patient solidarity, breath a little fire.

Drs. Friedman and Levine told it like it is. Same as it ever was.Thank you.

Leigh Reynolds has no right to get preachy with the patients. Until we're not fighting with agencies like the CDC against a dilution of the very definition of the illness and that the kids and the most severely ill are basically ignored, all patients have the right to tell their stories. The CAA had a horrible track record with the CDC and representing the sickest of patients and does have not right to tell us what to say our how to say it. Learn your history Ms. Reynolds. You organization stopped 'advocacy' to do research. Thank goodness. Go read Osler's Web and observe your own organization's unwillingness to even acknowledge criticism in social media.

I agree the trail of tears doesn't necessarily move us ahead but in the short term it's vitally important to keep us from moving backward.

I also believe that the patient orgs and advocates are coming together more than ever but that doesn't mean every patient has to read a script. We have too many issues to be addressed and that need to be kept in front of the committee.

Ember August 19, 2013 at 5:50 pm
Sasha

I thought Dr Friedman's suggestion about a name change was interesting…. It seems a good one because it describes the systems affected (and the ones that I think you have to have under the CCC to get a diagnosis)….

The CCC does require neurological/cognitive manifestations. But neither neuroendocrine nor immune manifestations are required for an ME/CFS diagnosis. An ME/CFS patient need have only one of the two of these: “A patient with ME/CFS will meet the criteria for fatigue, post-exertional malaise and/or fatigue, sleep dysfunction, and pain; have two or more neurological/cognitive manifestations and one or more symptoms from two of the categories of autonomic, neuroendocrine, and immune manifestations; and adhere to item 7.”

Erik Johnson August 19, 2013 at 11:58 pm

It was so much simpler back in 1987.
On top of the abnormalities in CEBV Syndrome, elevated RNase L in the 2'5a synthetase pathway, Cheney and Peterson found a new virus, B cell dysfunction. Low NK cell cytotoxicity and UBO's on MRI scans.

The CDC coined a new syndrome and was going to find out what they meant.

Nowadays I am told that these are only things "found in CFS", as if they are totally optional.

That's weird. The CDC had no intention of changing CEBV Syndrome until they saw this evidence.
We thought they "were" CFS, as they were the reasons why the syndrome was created.

Sasha August 20, 2013 at 2:29 am
Ember

The CCC does require neurological/cognitive manifestations. But neither neuroendocrine nor immune manifestations are required for an ME/CFS diagnosis. An ME/CFS patient need have only one of the two of these: “A patient with ME/CFS will meet the criteria for fatigue, post-exertional malaise and/or fatigue, sleep dysfunction, and pain; have two or more neurological/cognitive manifestations and one or more symptoms from two of the categories of autonomic, neuroendocrine, and immune manifestations; and adhere to item 7.”

Thanks – it's a while since I looked at the CCC but even though each category may not be necessary in an individual patient, the presence of those categories in the diagnosis make the name reasonable, I think. Not perfect, but a big step up from CFS.

Sasha August 20, 2013 at 2:38 am
Otis

I agree the trail of tears doesn't necessarily move us ahead but in the short term it's vitally important to keep us from moving backward.

I also believe that the patient orgs and advocates are coming together more than ever but that doesn't mean every patient has to read a script. We have too many issues to be addressed and that need to be kept in front of the committee.

I completely agree that patients have the right to give whatever testimony they want but I think that many patients, if they were aware of an option for a joint advocacy action like this, might choose, in part of their testimony, to call for the same two or three priority actions. That only takes twenty seconds of a five-minute testimony.

I don't think that that committee can go backward. There's no further backwards for it to go. And I do think that part of the problem in moving forward has been the sheer multiplication of issues, which I would agree has been due to a failure of those further up the chain to implement the committee's recommendations in the past. If the patients and the committee keep doing the same thing over and over – same kind of testimony, too many issues – they'll get the same results. Something has to change, and the thing under patients' own control is their testimony. I think that's an opportunity to be grabbed with both hands.

heapsreal August 20, 2013 at 3:18 am

if nk function isnt being used for an ME diagnosis then they arent taking it seriously. Its not the be all in a diagnosis but will go along way and like already mentioned, its been known about for years, theres also other immune tests that could also be used in combination with other tests like L rnase as well as certain cytokine profiles. Alot of these type of tests can help weed out non ME patients that get caught in the net of cfs diagnosis which would help alot more in furthering research. This could also help further research in the non ME illnesses as well instead of having a mixed bag of lollies.

Also whats wrong with the international consesus criteria, maybe tweaked abit but its basically agreed upon by most of the cfs/me gurus that are persuing this illness the most aggressively. I havent read the above fully, im mostly a skim reader, but are they trying to reinvent what the internation consensus criteria have brought out??

Nielk August 20, 2013 at 5:35 am
Sasha

Excellent interview, Gabby – really well-chosen questions.

Thank you Sasha – It is really the participation and the replies from the committee members that made the article interesting.:)

Sasha

I completely agree that patients have the right to give whatever testimony they want but I think that many patients, if they were aware of an option for a joint advocacy action like this, might choose, in part of their testimony, to call for the same two or three priority actions. That only takes twenty seconds of a five-minute testimony.

I think that it is a great idea to include a joint advocacy action to concentrate on one or two key issues. It is important for us to pool our resources together and make it work for us the best possible and most effective way.

Sasha August 20, 2013 at 5:44 am
Nielk

most defective way.

Effective! Effective! :aghhh:

Nielk August 20, 2013 at 5:49 am
Otis

Looks like we mostly disagree Sasha.

Dr. Marshall gave a politician's set of answers that are typical for the chair of this committee. I like the man but he isn't a leader or an organizer. I think the biggest required change is that the committee needs to lead and show some nerve to call out the Dr. Kohs of the world for not supporting the committee and the patients. What are they going to do? Fire you? Cut off the non-existent funding? It seems that to serve on the committee one must drink the "we can only do so much" koolaid and sign in blood to not rock the boat. BS, if you're there for the patients show some passion instead of behaving like you are just glad to be there and that your hands are tied. If you want a show of patient solidarity, breath a little fire.

I and I'm sure all ME/CFS stakeholders share your frustrations with the ineffectual way that CFSAC has moved in it's history. I don't believe though that one can put blame on Dr. Marshall. His task is not so much to lead than to direct and chair the meeting. He is not the one who sets the agenda nor is he the one who has the power to fulfill recommendations. My frustrations/anger would be more directed towards the NIH and CDC representatives.

Drs. Friedman and Levine told it like it is. Same as it ever was.Thank you.

Leigh Reynolds has no right to get preachy with the patients. Until we're not fighting with agencies like the CDC against a dilution of the very definition of the illness and that the kids and the most severely ill are basically ignored, all patients have the right to tell their stories. The CAA had a horrible track record with the CDC and representing the sickest of patients and does have not right to tell us what to say our how to say it. Learn your history Ms. Reynolds. You organization stopped 'advocacy' to do research. Thank goodness. Go read Osler's Web and observe your own organization's unwillingness to even acknowledge criticism in social media.

I don't read it as Leigh being preachy to us. She graciously replied to my question as to how patients can best proceed. I feel that she gave an excellent answer and has a unique perspective having worked with different patient groups. It is obvious to me that what we have done so far is not working too well for us and we can use some fresh perspective and advice.

Nielk August 20, 2013 at 5:50 am
Sasha

Effective! Effective! :aghhh:

Thanks Sasha. I edited it. Now, how can I make a mistake like that?:mad:

Nielk August 20, 2013 at 6:03 am

Dr. Marshall said:

I empathize with those who passionately believe the name of this illness needs to be changed. I still vividly remember some of my colleagues in Texas “rolling their eyes” when they found out I was caring for patients with CFIDS (the name at the time). Even in those early days (for me), I noticed the spectrum of symptoms and responses (or lack thereof) to treatment which made it difficult to put all the patients neatly into a single diagnostic category.

Dr. Levine said:

I guess over the years I've been struck by the substantial lack of support in the medical community and in some cases, hostility in my immediate medical community, towards acknowledging its existence; although that has changed a little. I found that my NY colleagues are willing to identify their patients who suffer from CFS/ME or at least make a tentative diagnosis but then don't want to deal with it from there.

It was interesting to hear from doctors' perspectives how they too encounter frustrations with the condescending way this disease is looked at by the medical community at large. This drives home the fact that education of doctors is so important if we are to take care of ME/CFS patients properly.

Nielk August 20, 2013 at 6:08 am

Dr. Friedman said:

It would be useful if ME/CFS patients could support the Committee and its members. From my viewpoint, the Committee was most effective when large numbers of patients were in the audience at the CFSAC meetings and exhibited some signs of militancy. It was clear that the DHHS did not want patient demonstrations and seemed more willing to negotiate agenda items when failing to acquiesce to CFSAC recommendations might possibly result in patients demonstrating their disapproval.

Dr. Friedman has a lot of experience serving on CFSAC. It is an important perspective that he brings to us. I hope that patients and/or family members could make more of an effort to attend the meetings. It does drive a point if one sees a roomful of people there.

Roy S August 20, 2013 at 6:27 am

Ken Friedman:
"From my viewpoint, the Committee was most effective when large numbers of patients were in the audience at the CFSAC meetings and exhibited some signs of militancy."

I think Ken Friedman has done some great things, but from my viewpoint, unless and until we get large numbers of non-patients* involved we are not really going to get anywhere.

***non-patients ***– as in family and friends, etc.

For example, Alzheimer's research gets hundreds of millions of dollars a year. It wasn't Alzheimer's patients that did the advocacy. It was mostly family members — as it is with other illnesses. I heard that from people in key positions on Capitol Hill over 20 years ago.

Edited to add that I was going to write about this yesterday but was too sick and now Neilk posted about it while I was writing the above.

Nielk August 20, 2013 at 6:52 am
Roy S

Ken Friedman:
"From my viewpoint, the Committee was most effective when large numbers of patients were in the audience at the CFSAC meetings and exhibited some signs of militancy."

I think Ken Friedman has done some great things, but from my viewpoint, unless and until we get large numbers of non-patients* involved we are not really going to get anywhere.

***non-patients ***– as in family and friends, etc.

For example, Alzheimer's research gets hundreds of millions of dollars a year. It wasn't Alzheimer's patients that did the advocacy. It was mostly family members — as it is with other illnesses. I heard that from people in key positions on Capitol Hill over 20 years ago.

Edited to add that I was going to write about this yesterday but was too sick and now Neilk posted about it while I was writing the above.

@Roy – You make a very good point. How can we inspire family and/or friends to get involved and why is it not happening like in other illnesses?

Nielk August 20, 2013 at 7:04 am
Ember

The CCC does require neurological/cognitive manifestations. But neither neuroendocrine nor immune manifestations are required for an ME/CFS diagnosis. An ME/CFS patient need have only one of the two of these: “A patient with ME/CFS will meet the criteria for fatigue, post-exertional malaise and/or fatigue, sleep dysfunction, and pain; have two or more neurological/cognitive manifestations and one or more symptoms from two of the categories of autonomic, neuroendocrine, and immune manifestations; and adhere to item 7.”

The CCC requires besides PEM, neurological/cognitive symptoms and at least one autonomic or immune manifestation. When I think of ME/CFS, I think of the CCC definition since that is the language that they use.

Erik Johnson August 20, 2013 at 7:08 am

By 1986 it was plain CDC had no intention of altering CEBV Syndrome, of studying it, funding it, or even according it a decent amount of credibility that would have generated more research.

Tens of thousands of people called the CDC for help. None was received.
Numbers of desperate pleas clearly does not inspire any response from the CDC/NIH.

The only thing that made them sit up and take notice was the threat of being exposed for failing to respond to new evidence found by Cheney and Peterson.
Creating a new "research tool" of CFS was the token gesture of deference that this evidence was found.

The moment they maneuvered that evidence into the "inconclusive" category was the exact moment they sat right back down again… and went back to Business-As-Usual.

Nothing less than the discovery of some new illness process which threatens to expose them for malfeasance,
if they were to completely ignore it….. has been known to get their attention.

Roy S August 20, 2013 at 7:57 am
Nielk

@Roy – You make a very good point. How can we inspire family and/or friends to get involved and why is it not happening like in other illnesses?

Well, I wrote about it a little the year before last here:
 
http://forums.phoenixrising.me/inde…ion-breakdowns-with-family.11736/#post-201915
 
What would be really funny is if I was extra tired and brain fogged right now because of pursuing the same thing.

If I had been doing that.

Nielk August 20, 2013 at 9:18 am
Roy S

Well, I wrote about it a little the year before last here:
 
http://forums.phoenixrising.me/inde…ion-breakdowns-with-family.11736/#post-201915
 
What would be really funny is if I was extra tired and brain fogged right now because of pursuing the same thing.

If I had been doing that.

Thank you Roy for this link and the link to "your story". It is very informative. I recognize myself in so much that you said. Your hard work on our behalf is much appreciated. I hope that it didn't take too much of a toll on you.

In much of the advocacy history that you describe, many ME/CFS patients who want to be involved get easily burned out. It is hard to run a real efficient advocacy work/lobby with only patients. I think that we are starting to see more family members getting involved but, definitely not enough.

Otis August 20, 2013 at 10:01 am

I just lost a huge post and my arm pain is over the top today so a short summary will have to do.

Heaps – I agree. This is validated and should be used, just maybe not exclusively. I agree that an exercise challenge is useful but isn't feasible for the sickest of the sick. I'm almost bed bound. My CFS doc, who uses these tests, along with my GO agree this will most likely make me permanently worse. The medical community needs to be looking at this as a complex illness and treat it as such. MS is quite similar. Diagnosis isn't a blood test, it's a work-up and ME should be looked at the same way. But our own medical advocates need to preach that it isn't so damn hard to Dx. Use the ICC or at least the CCC. Think just a little docs. The era of overly simplified, flow chart, medicine is a joke. It's no wonder the US isn't close to the top of the world in medical/mortality outcomes, our diet not withstanding.

The committee makes it's own limitation, most importantly the chair. This was the biggest part of my lost post. They control the charter and bylaws – meaning they can change them – but don't even know them, let alone understand them. They also need to learn to be more forceful. E.g. "As the DHHS appointed authority we asked you, CDC, to take down the toolkit. For the record, tell the Secretary are you going to do that or not? And we can lose ground. The CDC wants to keep studying idiopathic chronic fatigue and calling it CFS. The advocates have taken this on and I expect there will be lots of testimony on the subject come October, without the divine hand of the CAA guiding it. But if the committee doesn't take a forceful stand with the CDC – it will take us backward – AGAIN!

I stand by my statements about the CAA. Justin, can you help me man?

Roy and Erik. Glad you came out to play on this topic! We need your perspective.

Otis August 20, 2013 at 10:04 am

Hmm. Despite the system telling me I had been logged out apparently it, albeit belatedly, made my original post. I did check and it wasn't there when I started over.

So sorry for the mostly redundancy of the last post.

Sparrowhawk August 20, 2013 at 2:54 pm

I, too, thought this piece was interesting: "Many years ago, we characterized CFS as a neuro-endocrine-immune disorder because these are the organ systems usually affected. At the current time Neuro Endocrine Immune Dysfunction would be my personal choice of new names for ME/CFS." I had just been wondering about this yesterday but missed the important endocrine piece of the designation.

Vitally important from a downstream effects standpoint is how a name change can influence everything from the immediate (diagnosable, respect, public – work – family perception, likelihood to get further research $$ and interest/participation) but also things like disability claims. If I get a formal diagnosis of Neuro Endocrine Immune Dysfunction and put it on my disability claim, would they still put a two year max limitation on it like they do for CFS (which is one of only FOUR exceptions to lifetime coverage, and is the same as for alcohol and drug addiction recovery — lovely company to keep)? One would hope that a diagnosable condition that has clear biomarkers, and a specific prognosis would help. Things like MS, stroke, and Parkinsons can get lifetime disability, CFS not so much.

On the family members and advocacy piece I hazard that most immediate family who could do something along those lines are busy picking up the slack and caregiving. Not sure if a concerted study of previous successful movements (as per the comment about Alzheimer's advocacy above) might be helpful, as benchmarking? Ye gods, would be great to have the equivalent of coworkers all out doing marathons to raise funds the way they do the Leukemia and Lymphoma Society.

It is a bloody shame that as per other comments above we should be feeling we have to blackmail our topic committee and CDC into doing anything useful

Ember August 20, 2013 at 3:01 pm
Nielk

The CCC requires besides PEM, neurological/cognitive symptoms and at least one autonomic or immune manifestation. When I think of ME/CFS, I think of the CCC definition since that is the language that they use.

So do I, Nielk, and I was quoting the CCC. In addition to neurological/cognitive manifestations, the CCC requires that an ME/CFS patient “have one or more symptoms from two of the categories of autonomic, neuroendocrine, and immune manifestations.“ It's interesting that an ME/CFS patient with an autonomic symtom need not have both a neuroendocrine and an immune symptom, interesting especially given the fact that 5 of 15 CFS patients in phase II clinical trials of rituximab were unresponsive to treatment. Were the unresponsive five patients missing one of these two manifestations?

Dr. Friedman's “Neuro Endocrine Immune Dysfunction” label might better fit an ME patient, the ICC being more selective and coherent:

Myalgic encephalomyelitis is an acquired neurological disease with complex global dysfunctions. Pathological dysregulation of the nervous, immune and endocrine systems, with impaired cellular energy metabolism and ion transport are prominent features. Although signs and symptoms are dynamically interactive and causally connected, the criteria are grouped by regions of pathophysiology to provide general focus.

The ICC suggests prominent-cluster subgroups: neurological, immune, metabolism/cardiorespiratory or eclectic (balanced), and PENE is itself defined as “a pathological inability to produce sufficient energy on demand with prominent symptoms primarily in the neuroimmune regions.”

Kati August 20, 2013 at 3:26 pm

No one mentioned it yet but here is, in my opinion, the most important quote of the article

Dr Freedman: "While some may argue, I would say that the Stevens’ Protocol, which uses two-day CPET (CardioPulmonary Exercise Testing), is an effective way to diagnose ME/CFS. I view the Stevens’ Protocol as the first scientifically and physiologically valid method of diagnosing ME/CFS."

Sparrowhawk August 20, 2013 at 3:46 pm
Kati

No one mentioned it yet but here is, in my opinion, the most important quote of the article

Dr Freedman: "While some may argue, I would say that the Stevens’ Protocol, which uses two-day CPET (CardioPulmonary Exercise Testing), is an effective way to diagnose ME/CFS. I view the Stevens’ Protocol as the first scientifically and physiologically valid method of diagnosing ME/CFS."

OK. But as someone who is still recovering from a simple glucose tolerance test, I get that this will be a tough hurdle for the really sick. And even for those doing relatively well such an ordeal could still knock us back for weeks or months. I wouldn't do it unless the outcome would lead to clearly significant later support, like disability qualification.

Kati August 20, 2013 at 3:54 pm

For someone who is newly sick with all of these vague symptoms, wouldn it be nice to have a test that could confirm or eliminate a ME dignosis?

Of course, the severely ill is excluded, however by now,yearsafter onset, they already know what they got, because they went through the diagnosis by exclusion.

It is not a perfect dignositc tool. But then, what else have we got? NK cell function is not as specific/sensitive but then what do I know. (My NK cell function was still normal 18 months afteronset but dropped below normal at 24 months.

Sparrowhawk August 20, 2013 at 4:03 pm

Yes, agreed. Good points. And then establishing related norms, variances and curves for metabolic indicators/responses in the newly sick when they step up to the two day challenge becomes another helpful data set with its own diagnostic promise. In other words if they find X or Y is a common biomarker for all the folks who get provable PEM from the challenge test, eventually those may be accepted as proxies for the test.

Not to get to far ahead of things!

Kati August 20, 2013 at 4:07 pm

In my opinion, the sooner we have biomarkers, may them be blood, spinal fluid, or exercise test, the better.

Who decide anyways what's a biomarker and what isn't? CDC has not volunteered any in the past 30 years. dr Freedman is doing us a favor by saying what he said. It's a good thing.

heapsreal August 20, 2013 at 4:50 pm
Kati

In my opinion, the sooner we have biomarkers, may them be blood, spinal fluid, or exercise test, the better.

Who decide anyways what's a biomarker and what isn't? CDC has not volunteered any in the past 30 years. dr Freedman is doing us a favor by saying what he said. It's a good thing.

There are biomarkers out there and maybe we have to have several for a 'full' diagnosis, nk function seems to be the stand out, rnase is another, cytokine patterns which i read last night that il5 is a stand out. I think klimas stated il5 with nkfunction would be almost fool proof?? And then those that can manage the 2 day exercise tests. There was acouple more that i saw on a talk by dr peterson. If they fit the CCC criteria and then most of the biomarkers then they get a diagnosis of ME, if they only get the CCC but not the biomarkers then maybe class them as neuro-immune but should be followed closely for when/if biomarkers occur.

Its not rocket science but us dum arses with brain fog can work it out, why cant these intellects do it. Makes us realise how political it all is and patient care is a distant second or third on the list behind politics.

Sparrowhawk August 20, 2013 at 4:59 pm
heapsreal

Its not rocket science but us dum arses with brain fog can work it out, why cant these intellects do it.

Bloody right. I was just wondering if any of them even read this forum, so much anecdotal data and real life experience reported on various therapies here that could be informing their work…

heapsreal August 20, 2013 at 5:03 pm
Sparrowhawk

Bloody right. I was just wondering if any of them even read this forum, so much anecdotal data and real life experience reported on various therapies here that could be informing their work…

They probably wouldnt lower themselves to listen to us, they know better????

Ember August 20, 2013 at 5:31 pm
heapsreal

I think klimas stated il5 with nkfunction would be almost fool proof??

Is this something new? The ME Primer provides these immune system profiles:

Immune system profiles: *NK cell function & cytotoxicity; B & T-cell function: IgG,IgG subclasses 1-4;
IgA, IgM (shift from T1 to T2), cytokine/chemokine profile panel (94% accuracy): IL-8, IL-13, MIP-1β, MCP-1, IL4,
flow cytometry for lymphocyte activity, □ ↑37 kDa 2-5A RNase L immunoassay – defect/ratio & bioactivity,
food sensitivity panel, chemical sensitivities, stool for WCB – D-lactic acid bacteria balance, ova & parasites,
autoimmune profile, Intestinal dysbiosis:IgA & IgM for intestinal aerobic bacteria in serum, □ ↑ leukocyte elastase activity in PBMCs, IgG food intolerance test,toxoplasmosis

Dr. Klimas is, of course, one of its authors.

heapsreal August 20, 2013 at 5:47 pm
Ember

Is this something new? The ME Primer provides these immune system profiles: Dr. Klimas is, of course, one of its authors.

I didnt see it in the primer but heard it in a utube talk?

WillowJ August 20, 2013 at 7:21 pm
Sasha

I'd like to see patient after patient after patient slamming home the same agreed two or three points in testimony after testimony – ramming those points home. Doing the prioritisation for the committee, not leaving it up to them.

The difficulty I see is in finding and contacting those patients who have testimony slots – or perhaps forming the agenda and then seeking volunteers to take those slots and push that agenda. But I think it's very, very well worth doing.

fwiw, we have been doing this for 2-3 years. I think it started with Marly? There information is out there.

I am not sure who decides on the agenda (and there is probably room for more community involvement here) but it's always included some things I thought I could support. The message is usually, "whatever else you say, try to include 1-2 of these 5 points" or something like that.

I think it's been successful. At the committee meetings, we hear testimony after testimony agreeing on the same items. And I think it's working. Both CDC and NIH are indeed changing definitions. Now they still need to be told that:

1) we need an immideate temporary change even if we change it shortly. there are several existing options which, while not perfect, would be improvements

2) they (especially NIH who seems to be working in secret) need to take input from us

I am not sure what CDC is doing. They are working partly with our clinicians on one project which is an amazing step for them, and then they do stupid stuff like create registries with random inexperienced clinicians recruited by a marketing company, where the patients can't have any lab tests come back different from healthies.

In Fukuda they wrote that they wanted to figure this out, and then they lost track of what they were doing. Somewhere in there they forgot that the objective was to actually FIND abnormalities and figure this out.

As far as local cohorts go, be it Incline Village or Royal Free, in science we have something called "generalizability". Something interesting is found, and then studied on a broader scale to see what part is due to local (or other specific) factors and what part is the broader thing itself.

So far we know reduced NK cell function is generalizable. We can use this as a marker in the same way that ANA is used as a marker: it does not designate any specific disease, but it indicates a disease process and it contributes to diagnosis (in the case of ANA, for several diseases). Depending on the disease, they also use other markers and signs and symptoms.

There are few diseases which are diagnosed with just one marker.

I have always thought, and continue to think, that what we have collected as ME/CFS (not counting the non-neuro-immune misdiagnoses) could be more than one disease, and it's encouraging to see Stephen Holgate say the same.

Of course it's not the patients' problem that many of us are collected together. Neither is this unusual for diseases in general: rheumatoid arthritis, for example, is thought to be several different diseases with different causes and different treatments.

WillowJ August 20, 2013 at 7:29 pm
Nielk

@Roy – You make a very good point. How can we inspire family and/or friends to get involved and why is it not happening like in other illnesses?

It does happen some. In cases where it doesn't, I think it's because

1) their time and energy is full from taking care of us (in some other diseases with similar disease burden to severe and very severe levels, patients would often have assistive devices and even 24-hour nursing care) or

2) they are disengaged because of the stigma or

3) they are just not that kind of a person anyway/ don't have the skills (and wouldn't engage even if it were a different disease) or

4) there is a lack of response from government, etc., which is discouraging. However, this is beginning to change. So it's a good time to try (or try again).

Questus August 20, 2013 at 8:24 pm

Am so very pleased to see Mary Ann Fletcher, Ph.D. on this board. She has so much to offer. Hope PR will highlight her unique and significant viewpoint!

Thank you for your service Mary Ann Fletcher Ph.D.

Best,
Questus

Sasha August 21, 2013 at 12:01 am
WillowJ

fwiw, we have been doing this for 2-3 years. I think it started with Marly? There are informal overlapping networks, utilizing email lists, Twitter, Facebook, and blogs.

I am not sure who decides on the agenda (and there is probably room for more community involvement here) but it's always included some things I thought I could support. The message is usually, "whatever else you say, try to include 1-2 of these 5 points" or something like that.

I think it's been successful. At the committee meetings, we hear testimony after testimony agreeing on the same items. And I think it's working. Both CDC and NIH are indeed changing definitions. Now they still need to be told that:
1) we need an interim change
2) they (especially NIH who seems to be working in secret) need input from us

Thanks, Willow, I didn't know that, and I'm surprised to hear about it. I've never noticed anything like that on PR. I'd like to see more community involvement – we could easily do a poll on PR. I think a message is stronger if it can be demonstrated it's got community backing (as could be demonstrated with a poll). I think there's much greater potential for a 'wall of patients' at CFSAC – there's a lot of testimony that doesn't request any specific action at all.

Nielk August 21, 2013 at 8:28 am
WillowJ

It does happen some. In cases where it doesn't, I think it's because

1) their time and energy is full from taking care of us (in some other diseases with similar disease burden to severe and very severe levels, patients would often have assistive devices and even 24-hour nursing care) or

2) they are disengaged because of the stigma or

3) they are just not that kind of a person anyway/ don't have the skills (and wouldn't engage even if it were a different disease) or

4) there is a lack of response from government, etc., which is discouraging. However, this is beginning to change. So it's a good time to try (or try again).

(my bold)

The "stigma" of ME/CFS seems to be all encompassing. It touches everyone; starting with patients, their families, doctors, clinicians, researchers..etc. I have been thinking about this a lot lately and wondering how we can come out from this hole. I would imagine that if a accepted biomarkers is found that points to a real biological disease, this would fade away. I thought that we had that with the repeat exercise tests.I am really surprised that Dr. Unger/CDC does not take this seriously. If this has been found to be true in some studies, why is there no desire to replicate it?

Nielk August 21, 2013 at 8:44 am
Kati

No one mentioned it yet but here is, in my opinion, the most important quote of the article

Dr Freedman: "While some may argue, I would say that the Stevens’ Protocol, which uses two-day CPET (CardioPulmonary Exercise Testing), is an effective way to diagnose ME/CFS. I view the Stevens’ Protocol as the first scientifically and physiologically valid method of diagnosing ME/CFS."

Exactly!
This is why patient groups and patient advocates have written a letter to CFSAC – see Mark's article.

Nielk August 21, 2013 at 8:51 am
Ember

Is this something new? The ME Primer provides these immune system profiles: Dr. Klimas is, of course, one of its authors.

This is from Cort's article at Simmaron:

Pathogens were discussed briefly. All three physicians were testing for them (eg; EBV, HHV6, CMV, Parvovirus, Coxsackie and bacteria) but there were some differences. Dr Enlander did not see a relationship between viral load and disease severity, something that Dr. Peterson, as we’ll see later has found, at least with one group of patients. Dr. Klimas has not found HHV6 to be a good marker either as patients don’t test positive consistently; in fact, she called ME/CFS a ‘good day, bad day viral disease’ as patients may test negative on a good day and positive on a bad one. That’s helpful for her as a physician but is not good enough for the FDA to test treatments against. The FDA needs a test that’s consistently positive.

What does Dr. Klimas find that tracks with severity? Natural killer cell functioning and IL-5 levels might be two markers the FDA could use to assess treatment effectiveness.
We don’t hear alot about IL-5 cells but they boost two immune factors of interest in ME/CFS; mast cells and B-cells. Overactive B-cells cause autoimmune disorders and, of course, also harbor EBV as well.

Nielk August 21, 2013 at 9:02 am
Otis

I just lost a huge post and my arm pain is over the top today so a short summary will have to do.

Heaps – I agree. This is validated and should be used, just maybe not exclusively. I agree that an exercise challenge is useful but isn't feasible for the sickest of the sick. I'm almost bed bound. My CFS doc, who uses these tests, along with my GO agree this will most likely make me permanently worse. The medical community needs to be looking at this as a complex illness and treat it as such. MS is quite similar. Diagnosis isn't a blood test, it's a work-up and ME should be looked at the same way. But our own medical advocates need to preach that it isn't so damn hard to Dx. Use the ICC or at least the CCC. Think just a little docs. The era of overly simplified, flow chart, medicine is a joke. It's no wonder the US isn't close to the top of the world in medical/mortality outcomes, our diet not withstanding.

The committee makes it's own limitation, most importantly the chair. This was the biggest part of my lost post. They control the charter and bylaws – meaning they can change them – but don't even know them, let alone understand them. They also need to learn to be more forceful. E.g. "As the DHHS appointed authority we asked you, CDC, to take down the toolkit. For the record, tell the Secretary are you going to do that or not? And we can lose ground. The CDC wants to keep studying idiopathic chronic fatigue and calling it CFS. The advocates have taken this on and I expect there will be lots of testimony on the subject come October, without the divine hand of the CAA guiding it. But if the committee doesn't take a forceful stand with the CDC – it will take us backward – AGAIN!

I stand by my statements about the CAA. Justin, can you help me man?

Roy and Erik. Glad you came out to play on this topic! We need your perspective.

Otis,

It is the DFO who manages the meetings. See below from CFSAC's charter.

The DFO will schedule and approve all meetings of the Committee and any respective subcommittees that are to be held. The DFO will prepare and approve all meeting agendas; development of the meeting agenda can be done in collaboration with the Committee Chair and, when it is deemed to be appropriate, chairs of the ad hoc subcommittees. The DFO or designee will attend all meetings of the Committee and any respective subcommittees. The DFO also has authority to adjourn meetings, when it is determined to be in the public interest, and can be directed by the Secretary or designee to chair meetings of the Committee.

Mesurfer August 22, 2013 at 2:40 am

In my opinion the most imortant qoute in this entire article is by Dr Kenneth Friedman and is the reason why other illnesses gut funded and ours doesn't.

"From my viewpoint, the Committee was most effective when large numbers of patients were in the audience at the CFSAC meetings and exhibited some signs of militancy. It was clear that the DHHS did not want patient demonstrations and seemed more willing to negotiate agenda items when failing to acquiesce to CFSAC recommendations might possibly result in patients demonstrating their disapproval."

The CDC will continue to ignore us if no pressure is applied.

Thanks for the great article.

Nielk August 22, 2013 at 10:01 am
Mesurfer

In my opinion the most imortant qoute in this entire article is by Dr Kenneth Friedman and is the reason why other illnesses gut funded and ours doesn't.

"From my viewpoint, the Committee was most effective when large numbers of patients were in the audience at the CFSAC meetings and exhibited some signs of militancy. It was clear that the DHHS did not want patient demonstrations and seemed more willing to negotiate agenda items when failing to acquiesce to CFSAC recommendations might possibly result in patients demonstrating their disapproval."

The CDC will continue to ignore us if no pressure is applied.

Thanks for the great article.

We need to start applying a lot more pressure if we want to see any results. It seems that all the letter writing and/or testimonies are being ignored. It is clearly not working. We need another avenue of action. Maybe protests are what is needed.

WillowJ August 22, 2013 at 10:33 pm

isn't keep up the pressure what Dr. Lipkin said?

WillowJ August 22, 2013 at 10:35 pm
Nielk

(my bold)

The "stigma" of ME/CFS seems to be all encompassing. It touches everyone; starting with patients, their families, doctors, clinicians, researchers..etc. I have been thinking about this a lot lately and wondering how we can come out from this hole. I would imagine that if a accepted biomarkers is found that points to a real biological disease, this would fade away. I thought that we had that with the repeat exercise tests.I am really surprised that Dr. Unger/CDC does not take this seriously. If this has been found to be true in some studies, why is there no desire to replicate it?

I wonder this, too. I worry about the repeat exercise test because only the better patients can do that, but it should e replicated with whomever is well enough.

But it's not like we lack other biomarker candidates – which have also not been followed up on.

Bob August 23, 2013 at 3:03 pm

Nielk, I've just got around to reading the article. Thanks very much for taking the time and effort to do this. :)

It's interesting to hear the personal perspectives of the committee members.

I agree with Dr Friedman that "Neuro Endocrine Immune Dysfunction" (NEID) would be a good name.

Bob August 23, 2013 at 3:13 pm
WillowJ

I am not sure what CDC is doing. [...] they do stupid stuff like create registries with random inexperienced clinicians recruited by a marketing company, where the patients can't have any lab tests come back different from healthies.

Hi Willow, are you able to elaborate on what you mean by this? i.e. what registries are you referring to?

Bob August 23, 2013 at 3:15 pm
Kati

No one mentioned it yet but here is, in my opinion, the most important quote of the article

Dr Freedman: "While some may argue, I would say that the Stevens’ Protocol, which uses two-day CPET (CardioPulmonary Exercise Testing), is an effective way to diagnose ME/CFS. I view the Stevens’ Protocol as the first scientifically and physiologically valid method of diagnosing ME/CFS."

Is anyone able to point me towards information on the Steven's Protocol please?
I'm not sure if I've come across it before.

Firestormm August 23, 2013 at 10:48 pm
Bob

Is anyone able to point me towards information on the Steven's Protocol please?
I'm not sure if I've come across it before.

Same as the Snell one, Bob. Indeed they appear to have developed it together :)

WillowJ August 24, 2013 at 12:52 am
Bob

Hi Willow, are you able to elaborate on what you mean by this? i.e. what registries are you referring to?

sorry about confusing you with the plural. just one registry. The Georgia one you posted up here.

WillowJ August 24, 2013 at 12:53 am

yes, thanks very much for the article. I enjoyed reading it :)

Bob August 24, 2013 at 4:44 am
jimells August 24, 2013 at 11:26 am
Nielk

Otis,

It is the DFO who manages the meetings. See below from CFSAC's charter.

This is really important. It demonstrates the purpose of the committee: lots of sound and fury signifying nothing. Obviously there are committee members who are truly trying to help us, but they are participating in an institution designed to be ineffective. Until the committee becomes independent, which the rules apparently do not allow, we are beating our heads against the wall.

share with us your thoughts on what we are doing but (and I understand the difficulty in this statement) be patient with us

When I read this, I nearly exploded. This is exactly what the civil rights leaders of the 1960s were told. Fifty years later, the "Whites Only" signs are gone, while millions of young black men are in prisons, jails, probation, parole, unable to find work, and abused by police on a daily basis.

Being patient is the last thing we should do. Any CFSAC chair who seriously suggests that we should simply wait another 30 years deserves to be tarred and feathered. After all, they are clearly too chicken to take the bureaucracy.

Ember August 24, 2013 at 11:57 am
Nielk

It is the DFO who manages the meetings.

Once the meeting is called to order, doesn't approval of the agenda fall to the Committee?

Ember August 24, 2013 at 12:27 pm

Under Robert's Rules of Order, a majority vote is required to adopt the agenda. After it's adopted, only a two-thirds vote or general consent may change the agenda. (Sorry, I should have asked about adopting rather than approving the agenda in my post above; the edit function isn't working for me.)

Nielk August 24, 2013 at 6:43 pm
Ember

Once the meeting is called to order, doesn't approval of the agenda fall to the Committee?

Dr. Kenneth Friedman said:

The CFSAC should be permitted to do its work. The CFSAC should set its own agenda and be permitted to follow it. The role of the Designated Federal Officer is to assist the Committee in performing its work. It is not the role of the DFO to set the agenda or interfere with the Committee's work and/or attempt to alter it.

It sounds to me that the DFO is setting the agenda and this causes frustrations to the committee members. How can they do their work effectively when they can't even set their own agenda???

Ember August 24, 2013 at 7:20 pm
Nielk

It sounds to me that the DFO is setting the agenda and this causes frustrations to the committee members. How can they do their work effectively when they can't even set their own agenda???

Couldn't a voting member seek adoption of the agenda (moving a motion if necessary) at the beginning of a meeting? Committee members would then be able to suggest or move amendments before any vote. In that way, the Committee could be setting its own agenda.

(Any insights, by the way, into the failure of the edit command?)

Mark August 24, 2013 at 7:29 pm
Ember

(Any insights, by the way, into the failure of the edit command?)

Probably this issue?
http://forums.phoenixrising.me/index.php?threads/edit-posts-not-working.24840/

Mary Schweitzer August 28, 2013 at 7:33 pm

Those were interesting interviews. Thank you for providing them, in this forum.

But nothing that has been suggested for patient advocates hasn't already been tried. CFSAC was not the first committee. That was the CFS-ICC (CFS Interagency Coordinating Committee), created sometime around 1990. My own experiences start with the CFSCC, or CFS Coordinating Committee, which began life in (I think) 1996. With both these committees, there was a microphone in the middle of the aisle, and public attendees were permitted to ask questions – specifically, to ask questions of the government representatives after they gave their presentations. It has been very frustrating to have had that shut down in CFSAC – why bother to go when you're gagged, forbidden to correct an error or ask a question, having to listen to the same public reps say the same things over and over? [They did allow questions at the last meeting, though you had to submit it in writing and could not ask directly.]

We used to get ten minutes – now it's five. They'll waste 20 minutes just talking among themselves about whether to go on break or not, when there's a really sick patient waiting to testify and about to pass out, and when the patient does testify, apparently no understanding that a slow, halting delivery is part of the disease – so timing it exactly to five minutes is kind of cruel.

Right now almost all of the speakers DO have a common agenda. First of all, we need much more funding by NIH. MUCH more funding by NIH. But NIH has a ready answer to that, which hasn't changed since 1996 (my first meeting): Oh, "NIH has plenty of money for CFS research, but we don't get enough good applications. We'll be holding a seminar for how to write an application next month." [Never mind that seasoned researchers like Robert Suhadolnik of Temple had no trouble getting funding for OTHER projects.]. It's really an insult, but they say it every meeting.

Everyone also agrees that the CDC website HAS to change. Or be deleted – it's that bad. It recommends CBT and GET (cognitive behavior therapy and graded exercise) as the only accepted treatments for CFS (!). When asked to get that off the website – particularly the exercise part, particularly given the results of VO2 MAX exercise testing by Chris Snell who was chair of the committee for a while, Dr. Unger of CDC flatly refused, even got angry (unusual for her) – "There's lots of research behind CBT/GET" she insisted. Okay, if you want to keep it, how about including the OTHER research that would suggest it's dangerous? "We direct people to Medscape – we can't put everything that was ever written on the website."

And it's a MYSTERIOUS condition. We really can't do anything without a biomarker. No, NK cells, cytokines, the Rnase-L defect, EBV, HHV-6, exercise testing – no, none of them are proven to diagnose CFS. We only wish it were true.

What a crock.

The chair does set the tone – the best chairs we have had were Donna Dean at the end of the 1990s, and in the 20-00's, Dr. Oleske, Dr. Bell, Chris Snell, Wanda Jones. Great recommendations. Never read. No response, except once every government agency had to say in what way they were adhering to the recommendations – boy was THAT a boring meeting. So much double-talk. And we had to listen in silence, unable to challenge a single statement or ask a single question.

I live 90 minutes north of Washington, by train, so I try to go to every meeting. I testify at every one of them, except when I got way too sick off Ampligen – that is, bedridden. I've been there in a wheelchair, lying on the floor for most of the meeting, putting everything I had into my five minutes, and collapsing after speaking. I think it's good for them to see really sick patients. Most of the government reps (and apparently our new CAA rep) know next to nothing about this disease – because you don't if you haven't lived it, either as patient or caregiver. Maybe you can learn, but you'd better be a very good listener.

The suggestion that they all watch the documentary "Voices" is excellent. I once gave them copies of the book that preceded the documentary. I wonder how many read it.

So we all agree that (1) we need more research funding from NIH – 100 times what we are getting, and I say that in all seriousness; (2) we need CDC to either put up a professional website that represents the depth and breadth of research on this disease, and the experience of long-time clinicians (which is how the Canadian Consensus Criteria were written) – or get rid if the website entirely. Better no information than information that will make patients sicker.

And (3) we need a sense of urgency. Above all else, URGENCY. CDC itself admits that of one million patients, 850,000 have no diagnosis. Six out of seven have no diagnosis. That's pretty pathetic after 25 years. As for the 150,000 who do have a diagnosis, with only a handful of specialists (as Dr. Levine aptly noted), well, it's at best 15,000 patients to one specialist, pretty bad odds.

Most of all, we need URGENCY before another generation is lost to this condition. There are patients who got sick at 18 and are still sick in their 40s. HOW CAN WE LET THIS HAPPEN AGAIN? At the least, it should be a reported diagnosis. At the least, with what we already know, we have to keep close tabs on young people who come down with EBV – this isn't "chronic EBV," but there is a connection, at least in a very large subset.

The late Bill Reeves once told me that CDC couldn't go public with the severity of this disease until they could tell people how to keep from getting it (!). It would cause panic. Really? How do you keep from getting MS or cystic fibrosis?

With everything patients and caregivers have been through, no one should be telling them how to testify. Listen to us instead.

Purple August 28, 2013 at 7:52 pm
Mary Schweitzer

The suggestion that they all watch the documentary "Voices" is excellent. I once gave them copies of the book that preceded the documentary. I wonder how many read it.

The film is 63 minutes long – the length of 13 patient testimonies.

Sasha August 29, 2013 at 12:44 am
Mary Schweitzer

So we all agree that (1) we need more research funding from NIH – 100 times what we are getting, and I say that in all seriousness; (2) we need CDC to either put up a professional website that represents the depth and breadth of research on this disease, and the experience of long-time clinicians (which is how the Canadian Consensus Criteria were written) – or get rid if the website entirely. Better no information than information that will make patients sicker.

And (3) we need a sense of urgency.

Welcome to the forums, Mary. Great post! What do you think is the best way to achieve this? What should patients be doing for the next meeting? Trying to push for those first two points (the specific, actionable ones)? Boycotting the meeting? Writing to committee members before the meeting? Writing to the people further up the chain who have failed to implement actions?

If there was a clear target for advocacy there, I think there's the potential for a mass action campaign by patients.

Sparrowhawk August 29, 2013 at 7:26 am
Mary Schweitzer

Those were interesting interviews. Thank you for providing them, in this forum.
[snip]

With everything patients and caregivers have been through, no one should be telling them how to testify. Listen to us instead.

This was all very well put and good to understand more of the history, thanks.

I was wondering if we could contact this author — who has done a lot in the last few months with this article to mainstream what has been considered a very marginalized disease of Lyme. Perhaps a follow up article interviewing some of our major CFS/ME practitioners and their theories (like enteroviruses). Thoughts? Is there a patient advocacy group that woudl take on contacting the author?

http://www.newyorker.com/reporting/2013/07/01/130701fa_fact_specter

Thanks.

Erik Johnson August 29, 2013 at 8:53 am

For so long as CFS advocates make the case that "CFS" was based on nothing and is just a generic term based on nothing, the CDC has them beaten.
No matter what is every found, all this does is place any new finding in jeopardy of having the patient removed from the CFS category, should it prove to be "real".

The only possible way to overcome the CDC's perpetual "We always win-You lose" stalemate is to point out that the syndrome was brought into existence due to original evidence compelling enough to create a syndrome, but apparently not good enough to keep researching until they found out what it meant.

Erik Johnson September 1, 2013 at 5:13 am

It is disgusting and contemptible to see "CFS" continually represented as "Having no abnormalities"
In 1987 after years of fighting to say "tests are inconclusive", the CDC caved in when they saw this.
They changed their tune and announced the creation of a new syndrome to study this…. and the other evidence described in Osler's Web.

It takes real gall for them to misrepresent the situation such that their definition is the real "CFS" but the illness it was based on is NOT.

——————————————————————–

North Lake Tahoe Bonanza

Nov 16 1987

"Incline Victims Show Cell Abnormalities"

Tests Reveal New Clue in Fatiguing Illness

by Chris Fotheringham
NLTB Managing Editor

Laboratory results published this week in a prestigious medical journal confirm that over 50% of Incline Village chronic fatigue patients tested have suffered "dramatic" abnormalities in their immune systems.

Calling it the "most significant finding yet" in efforts to unravel the mystery of the widespread fatigue illness, Harvard researcher Dr. Anthony Komaroff said Monday the report published Sunday in the Journal of Immunology is the first scientific study that confirms "something is wrong with these people."

"it is really dramatic." said Komaroff, who is chief of general medicine at a Harvard teaching hospital in Boston.

The article, which underwent nearly 11 months of peer review before being published, was authored by Komaroff, Incline Village internist Dr.Daniel Peterson, and former Incline internist Dr Paul Cheney.
Dr Michael Caligiuri, an immunologist with the Dana-Farber Cancer institute of the Harvard Medical Center, was the lead author for the article which was originally submitted for review in January.

Komaroff says test results reveal an attack on the immune system's "natural killer cell" which is the body's primary means of killing virus-infected cells or cells that become cancerous.
Komaroff said "There is a substantial reduction in the number of natural killer cells in patients tested." He said the study has determined that this "major defense against virus infection and cancer" is damaged in over half of the test cases involving Incline Village patients.

Komaroff first broght his team of researchers to Incline Village in February of 1986 after Incline doctors Cheney and Peterson had documented an outbreak of approximately 200 cases of mononucleosis-type illnesses in the North Tahoe and Truckee area beginning in the fall of 1985.
While the Incline Village cluster of fatigue cases has drawn primary attention in the national media, researchers have found widespread occurrence of the illness throughout the country.

See TESTS on page 9.

http://www.ncbi.nlm.nih.gov/pubmed/2824604

jimells September 2, 2013 at 12:02 pm
Erik Johnson

Komaroff says test results reveal an attack on the immune system's "natural killer cell" which is the body's primary means of killing virus-infected cells or cells that become cancerous.

And yet twenty-five years later it is still impossible for most patients to even get this test, simply because doctors refuse to order it.

Erik Johnson September 2, 2013 at 12:31 pm

Precisely. By rushing to base the 1988 Holmes CFS definition on the work Gary Holmes had done UP TO THIS POINT, this abnormality could be omitted, since it had not yet passed peer review.

In this way, the syndrome could be "officially" lacking in abnormalities, even though this evidence was among the very reasons the CDC abandoned CEBV Syndrome and created CFS.

By a simple switch in the "playing field" which makes people conceive of CFS as a definition in search of abnormalities, instead of a research tool to study them.

This was switched to "speculative".

The finding of which actually threatens to "Remove someone from the CFS category", if it should prove to be important.

Previous post:

Next post: