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