Behind Closed Doors

Posted on January 6, 2014 by Jennie Spotila

SecretsThere’s an important meeting happening at NIH today and tomorrow, but you probably know nothing about it. The secrecy of this meeting is intentional, and the implications of decisions made at the meeting are as far-reaching as the Institute of Medicine study. In fact, what I’ve learned about the meeting may strike you as worse than the IOM study process.

TL;DR Version

  • The P2P Working Group roster has not been made public.
  • The P2P Working Group will finalize the study questions for the evidence review and workshop.
  • I can exclusively reveal who was contracted to conduct that evidence review.
  • I can exclusively reveal the draft study questions.
  • The P2P panel, which will conduct the Workshop and write its report, will be 100% non-ME/CFS experts.

What Meeting Is This?

 
January 6-7th is the first meeting of the Working Group for the Pathways to Prevention Workshop on ME/CFS. You may be more familiar with the old name for the meeting, the NIH Evidence-based Methodology Workshop. At the May 2013 CFS Advisory Committee meeting, Dr. Susan Maier clarified the purpose of the Workshop “is to identify methodological and scientific weaknesses in a scientific area and move the field forward through the unbiased and evidence-based assessment of a very complex clinical issue.” The Workshop itself will not create a research definition for ME/CFS, but Dr. Nancy Lee said that the output of the workshop could be used to inform such a definition. (CFSAC Minutes, May 23, 2013, pp. 6, 48-49)

The Pathways to Prevention Program (P2P) is operated through NIH’s Office of Disease Prevention. Each workshop process takes about a year from start to finish, and its foundation is a technical brief providing “an objective description of the state of the science, a summary of ongoing research, and information on research needs.” This brief is prepared by one of the Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers (EPC).

At today’s meeting, the Working Group will finalize the study questions that frame the entire workshop process. Obviously, the questions are of critical importance since they form the basis for the evidence review and technical brief, as well as the public workshop itself. But before we get to the questions, don’t you want to know who is on the Working Group?

Who Is On This Working Group?

 
Guess what? We don’t know. At the May 2013 CFSAC meeting, Dr. Maier reported that 35-40 potential names were forwarded to the Office of Disease Prevention for possible service on the Working Group. She said that the list included ME/CFS experts, advocates and patients, including some CFSAC members. Despite vigorous objections expressed by Dr. Mary Ann Fletcher, Dr. Maier did not share the list, did not allow CFSAC to provide input, nor did she indicate a timeline for the release of that roster. (CFSAC Minutes, May 23, 2013, pp. 8, 49)

Unfortunately, Dr. Maier also did not provide the roster at the December 2013 CFSAC meeting and, to my dismay, no one on CFSAC asked her about it. Dr. Maier has also refused an individual request for the roster prior to the meeting, citing “standard procedure,” and there is no indication whether or when that information will be made public.

Why is this a big deal? Because the Working Group helps shape the entire workshop process. According to the P2P site, “the Working Group is involved from the beginning to the end of the workshop planning process; it finalizes the questions that frame the workshop, nominates panelists and speakers, and selects the date of the workshop.” Interestingly, the Working Group is made up of “content area experts from the federal government, academia, and clinical practice.” Dr. Maier said the nomination list included advocates and patients, but we have no way of knowing if any were actually appointed to the Working Group.

The Study Questions

 
Dr. Beth Collins Sharp described the evidence review process in detail at the May 2013 CFSAC meeting. One of the AHRQ EPCs is contracted to conduct a comprehensive evidence review based on study questions. Those study questions were drafted by unknown federal employees, and are finalized with the input of the Working Group, the EPC and federal participants. This is happening today and tomorrow.

As Dr. Collins-Sharp said in May, “You can’t get the right answer if you don’t ask the right questions.” (CFSAC Minutes, May 23, 2013, p. 12) However, Drs. Maier and Collins-Sharp have refused an individual request for the study questions being presented to the Working Group today, and have said only that the final questions will be posted by AHRQ and ODP but provided no timeline for this. Incidentally, they have also refused to disclose which EPC was contracted to perform this review.

However, I can answer both those questions today because I obtained a copy of the EPC task order through FOIA. The “Small Systematic Review for Diagnosis and Treatment of Myalgic Encephalophyelitis/Chronic Fatigue Syndrome (ME/CFS)” will be conducted by the Oregon Health & Science University for $358,211. I will discuss this contract in more detail in a future post. For now, I draw your attention to the draft questions as stated in the Task Order, and presumably being presented to the Working Group today:

I. How do ME and CFS differ? Do these illnesses lie along the same continuum of severity or are they entirely separate with common symptoms? What makes them different, what makes them the same? What is lacking in each case definition – do the non-overlapping elements of each case definition identify a subset of illnesses or do they encompass the entirety of the population?

II. What tools and measurements will help define the subsets of individuals in the entire spectrum on ME/CFS? Are some of these tools already available and can they reliably detect a subset of illnesses? Is it possible to identify which subset of individuals is not defined by the current tools and measurements? What is unique about the illness quality in those individuals not captured by the tools available?

III. What are the characteristics of the individuals who respond to specific treatments in terms of the spectrum of the disorder? Why do some individuals not respond? What aspect of the disorder is most relieved by specific treatments? For treatments that have been shown to be effective, what are (is) the underlying mechanism(s) of action of that intervention?

IV. What does clinical research on ME/CFS tell us about clinical diagnosis of ME/CFS? Are there hints in the current literature for a consistent defining characteristic? In the clinical realm, what differentiates borderline “cases” into confirmed versus probable? Do co-morbidities help define subsets of the clinical cases?

V. Have previous research findings shaped current clinical practice or are research and clinical practice completely separate with respect to the illness? How much influence does biomedical research help shape [sic] the future of ME/CFS research?

There are so many issues with this list. For starters:

  • Asking whether ME and CFS differ is critical (I), but this question fails to ask whether the mixed bag of “CFS” is even a valid clinical entity to begin with. It’s also important to note that the remainder of the questions (II-V) revert to lumping ME and CFS back together as one illness.
  • Question II asks what tools/measurements can be used to identify subsets along the whole spectrum, i.e. NOT whether such a “subset” actually represents a separate illness. It also asks if there is a subset not defined by current tools and measurements. Huh? How could a subset be identified if there are no tools/measurements to identify them?
  • Question III, the characteristics of patients who do or do not respond to treatment, rests in part on case definition. Will a systematic review dig into the raw data on studies such as the PACE trial or Ampligen trials to identify characteristics of responders and non-responders? Can applicable case definitions in those study cohorts even be assessed retrospectively (e.g. to examine a Fukuda cohort to see how many met the Canadian criteria)? Will the systematic review treat studies with different case definitions as equivalent (e.g. Oxford studies are as valid and relevant as Fukuda studies)?
  • Question IV strikes me as the question actually being posed in the IOM study. The IOM will be identifying the evidence for various diagnostic criteria, and then develop evidence-based clinical diagnostic criteria.  Including the same type of question here seems needlessly duplicative. And what if the two evidence reviews come up with different answers?
  • Finally, I can answer Question V myself: it’s both. There are a number of key clinician-researchers who maintain a clinical ME/CFS practice and conduct research. For those individuals, their research influences their clinical care and vice versa. But for the rest of the world, we know that clinical care is completely divorced from ME/CFS research. Based on the horror stories we hear from patients, based on the dramatic under-diagnosis of the disease and simultaneous use of CFS as a wastebasket diagnosis, I think it is abundantly clear that research and clinical practice is separated by a great wall for most patients.

The Working Group’s planning appears to be closed to the public, and we have no input onto the final questions. We wouldn’t even have this draft list if I had not managed to file a successful FOIA request. The anonymous Working Group will finalize the questions, and these will be posted publicly – although we have no timeline for that.

Non-Experts By Design

 
Supposedly, the Working Group is made up of ME/CFS experts. That’s the impression Dr. Maier gave at the May 2013 meeting, and by the P2P website. But the P2P Panel is a completely different story.

The P2P Panelists perform several functions: review the evidence report produced by the AHRQ review; attend a pre-Workshop webinar to discuss the evidence report and additional materials; attend the Workshop and ask questions of the presenters; prepare a draft panel report; and review and incorporate public comments to finalize the report.

Panelists can be nominated by members of the Working Group BUT there are significant restrictions on their expertise. Specifically, the panelists:

  • May be knowledgeable about the general topic under consideration, but must not have published on or have a publicly-stated opinion on the topic.
  • Must not have intellectual conflicts, such as participation in statements by professional societies or participation in advocacy groups on the topic.
  • Must not hold financial or career (research) interests in the workshop topic.

keep-calm-and-bang-your-head-against-the-wallLet’s be very clear about what this means. If someone has ever published on or made a public statement about the diagnosis and treatment of ME/CFS, he/she is disqualified. If someone has participated in statements from professional societies or participated in advocacy groups, he/she is disqualified. If someone has a financial or research interest in the diagnosis and treatment of ME/CFS, he/she is disqualified. Furthermore, there is no public comment period on the panel roster like there was for the IOM panel. In fact, it’s not even clear to me how far in advance we will know who has been appointed to the panel.

If the IOM process makes you mad, then this process should make you furious. There will be no ME/CFS experts on the panel that writes the Workshop report identifying methodological and scientific weakness in ME/CFS, suggesting research needs, and providing “an unbiased, evidence-based assessment of a complex public health issue.” The only involvement of experts will be through the Working Group and through the presentations made at the Workshop. I only see one upside to this arrangement: anyone who has been associated with the psychogenic model of ME/CFS will also be excluded.

This process may work very well for the “generally noncontroversial topics” that P2P is designed to address. For example, I can easily imagine the benefit of non-experts examining the state of research for a rare genetic disease. Only one other disease has been examined through P2P: polycystic ovary syndrome. The P2P workshop examined the current diagnostic criteria, causes and risk factors, and prevention and treatment strategies. There were only four panel members: an obstetrician-gynecologist, a cardiologist, the executive director of the American College of Nurse-Midwives, and the Executive Dean for Research at the Mayo Clinic. No patients or advocates spoke at this Workshop. It is not clear to me how well received the panel’s recommendations were in the PCOS patient community.

There are obvious problems with trying to apply this process in ME/CFS. First, there is no single body system to focus upon. While the PCOS Workshop could draw on endocrinologists, gynecologists and women’s health experts, what is the specialty pool for ME/CFS? Second, it is well known, and I believe generally accepted, that doctors and researchers without ME/CFS expertise will still have preconceptions about the disease. We need look no further than FDA for an example. It wasn’t until after the four-hour active listening session in April 2013 that FDA representatives, by their own admission, began to understand the seriousness of the disease, and this was a group of people who were familiar with ME/CFS to some extent. If the P2P panel is comprised of people with little ME/CFS knowledge and possibly negative preconceptions, and the Workshop does not include significant participation from ME/CFS patients and advocates, it seems unlikely that the best results will be achieved. Based on our decades of experience with misinformed scientists, clinicians, and policy makers, it is very hard to trust in such a process.

Bottom Line

 
Almost the entire process of this Workshop is being conducted behind closed doors. The Working Group roster has not been released. The Working Group meeting is not open to the public. The draft questions were obtained only through a FOIA. There is no information about when the final questions will be posted. We have no idea who will be on the Panel, or even who will make that decision. And the only way ME/CFS experts are likely to participate is through the Working Group (IF there are any on the Working Group) and through presentations at the meeting. The extent to which members of the public will be able to participate is completely unclear.

So if you are worried about the lack of ME/CFS experts on the IOM panel, or if you think that the public will not have a sufficient opportunity to participate in the IOM process, pay attention! The NIH P2P process looks even worse. We cannot lose sight of the forest for the trees, and IOM is not the only moving piece on this chessboard.

What can we do? I believe that advocates must demand more information about the P2P Workshop, and must demand meaningful opportunities to participate. The planning and execution of the Workshop should be transparent if it is to have any legitimacy in the advocacy community. I urge you to participate in both the IOM and P2P processes at every opportunity – ask questions, provide input, and present a united front based on the truths we know about ME/CFS. We cannot wait until the end of the P2P process to make our voices heard, especially since this process will provide input into the IOM study.

 

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There Is No Spoon

Posted on January 2, 2014 by Jennie Spotila

After I read How To Wake Up last summer, Toni Bernhard was kind enough to answer some of my questions about the book and the Buddhist practices she suggests. You can read the full text of our conversation here. This post has been in the works for many months, and I have felt very guilty about the delay. But as it happens, the beginning of a new year is the perfect time for me to reflect and refocus. I’m happy to share Toni’s wisdom with you today.

buddha-with-flowersMost of the plans I had for my life were wiped away like marks on a dry erase board when I got sick in 1994. Career? Children? Even grocery shopping? Gone, all gone. But I don’t want to be a person who always complains about what I can’t do or how sick I feel. One of my greatest struggles is to find a way to be content, even in the face of this suffering. I have only succeeded in doing so because of my spiritual journey.

One of the things I love (and sometimes hate) about spirituality and personal growth is that there is always more to learn. I am a Baha’i, but I draw inspiration and strength from many religions and spiritual traditions. Toni Bernhard’s books, How to Be Sick and How to Wake Up, have taught me about a Buddhist perspective on coping with suffering. I consider Toni to be one of my Teachers, and her lessons on detachment and impermanence have really helped me.

Many days, I long for escape from my body, this illness, my disability, my confinement in my home, my isolation. In the early years of being sick, I watched a lot of television – A LOT. I was too sick to read or write much. It was all I could do to pay the bills once a week and cook a little bit. Ignorant about ME/CFS and post-exertional malaise (it was the mid to late 1990’s), I was in a permanent push-crash cycle. All I wanted was out. Even now, when my cognitive function is somewhat improved and aggressive pacing/activity management has evened out my functionality, I still want out.

Toni’s second book begins with the necessity of waking up, of engaging life fully as it is. But why would I want to do that? I asked Toni if it was easier to not wake up to the pain in life. Some days, I think ignorance is bliss and distraction is divine. But Toni told me, “It depends on what you mean by ‘not being awake.’ To me, not being awake is a source of pain in my life in the form of mental suffering. By that I mean that one aspect of waking up is waking up to the realities of the human condition, so that we’re not deluded about what to expect in life.”

This, I understand. When I pretend my illness isn’t happening, either by pushing through my symptoms or by distracting myself, it actually doesn’t reduce my suffering. I might feel better in the moment of denial, but it’s impossible to maintain indefinitely. Sooner or later, the truth smacks everyone upside the head. I can’t pretend that I’m not disabled. Toni is right: when reality pushes through the flimsy wall of denial, it hurts more. Not only because my denial has probably led to a crash or other negative consequence, but because I’ve been fooling myself. That causes more pain.

But facing life as it really is in the moment, whether it’s good or bad, is not enough. We not only have to be present with whatever is happening, we need to recognize that we can’t have everything we want. Being dissatisfied with the way things are only creates more suffering. And even if we get what we want, it will be impermanent and change will come again. I could regain my health tomorrow, but I would still face illness and death again in the future.

One of the things I’ve learned from Toni is “weather practice.” In her first book, Toni describes seeing pain (physical, emotional, spiritual) as impermanent like the weather. No matter what I am feeling, it will pass. It will change. Knowing that pain and suffering will give way to beauty and joy makes it easier to bear the pain. And knowing that joy will give way to pain helps me stay detached from the high, so that my heart doesn’t break when it ends. There is a quote from the Baha’i Writings that I love:

Grieve thou not over the troubles and hardships of this nether world, nor be thou glad in times of ease and comfort, for both shall pass away. This present life is even as a swelling wave, or a mirage, or drifting shadows. – Abdu’l-Baha

lotus flower buddhaOne aspect of understanding impermanence and detachment has really troubled me. If everything is impermanent, and if wishing things were different causes pain, should we even try to make positive change? Certainly ME/CFS advocates want something different, as in all social justice movements. Many types of change or advancement in our personal lives comes from a desire for something more, something better. Does detachment mean giving up on achieving change? But Toni explained it to me this way:

Good things do come out of wholesome desires, such as the desire to be a civil rights or health advocate. The type of desire that the Buddha was cautioning us against is tanha. It’s an intense self-focused desire that’s experienced as a need. It leads us to think that if only we could get what we want (or get rid of what we don’t want), we’ll find lasting happiness. But the universal law of impermanence dictates that nothing lasts forever  . . .

Second, the wholesome desires I mentioned—those based on good intentions, such as care and compassion for others—can also become a source of dissatisfaction and suffering if we become attached to the results of our actions. This mean, do your advocacy work—with all your heart—but know that you may or may not succeed in your efforts. That wholesome desire can turn into the painful desire of tanha when you begin to feel that you need to get the results you want.

I have experienced the difference between wholesome desire for positive change and the painful desire of tanha in the last few months. I am passionate about doing whatever I can to contribute to a positive outcome in the IOM case definition study. I want such an outcome for all ME/CFS patients, not just myself. But I have sometimes fallen into the trap of believing that I will never be happy if the IOM process fails us. I think about what a bad result would do to us, and it feels like an abyss that I cannot see past. These thoughts cause me deep despair, and then the advocacy work becomes a source of true suffering. I have to act with all my heart, as Toni says, but also be personally prepared for (and a bit detached from) failure. That is the only way I have found to prevent this controversy from completely crushing me.

But I don’t control my mind all that well. My thoughts run all over the place, and it is far from orderly or sedate. There is a fantastic quote in How To Wake Up that captures this brilliantly. Toni quotes Bhante Gunaratana as saying, “Somewhere in this process, you will come face to face with the sudden and shocking realization that you are completely crazy. Your mind is a shrieking, gibbering madhouse on wheels barreling pell-mell down the hill, utterly out of control and hopeless. No problem.”

I laughed out loud when I read this the first time, because this is EXACTLY what my brain feels like. And as Toni explains, there is tremendous peace and relief in that realization:

He’s pointing to the fact that we can’t control what thoughts and emotions pop into our minds. Knowing this is tremendously helpful to me because it means that the key to peace and well-being is not controlling what thoughts and emotions arise, but learning to respond skillfully to them. . . .

The last step in that process is to “let it be” which, for me, is the best way to handle this crazy mind. We let it be by acknowledging whatever we’re feeling, without judgment or aversion. Then we patiently wait for the stressful thoughts and emotions to yield to the universal law of impermanence and pass out of our minds, while evoking compassion for ourselves over any suffering they’re giving rise to.

let goToni has helped me realize “we control a lot less than we think we do in life. When we can see this and accept it, then we’re better able to ride life’s ups and downs without being tossed around so much.” That sense of calm, peace and well-being is what I yearn for. Toni, in her kind and gentle way, has taught me that this is a possibility in each moment, and then the next, and the next.

I cannot force my life to conform to what I want. In reality, I have never been able to do that. All those plans I had that were wiped away by ME/CFS? There is no certainty that I would have ever achieved them anyway. In fact, the nature of existence is that at least some of them would not have come to pass. What I never grasped before reading Toni’s books is that, to quote the movies, there is no spoon. I cannot bend life to my whims, therefore it is I who must bend. Bend, and never break. Toni says:

Understanding that my dissatisfaction with my life can be traced to not getting what I want has helped me tremendously. I realized that I’m left with a choice—spend my days in frustration and dissatisfaction (dukkha) because I can’t get what I want (my health restored) or accept that I’m sick and that, although I’m doing my best to recover, I might not. In fact, I may be sick the rest of my life. I feel much better mentally when I’m able to give up the constant desire to get well. One reason that I feel much better is that it frees me to look around and see what life has to offer to me, even with this illness.

2013 was a brutal year for me. Our family dealt with multiple illnesses and surgeries, and my closest friends faced a number of difficulties. We joked that no one should want to be near us because we seemed to carry such a cloud of bad luck. But instead of seeing the year as the worst of my life, I’ve tried to reframe it as a year of miracles. We had many close calls, but my family is intact and on the mend. I have so much to be grateful for, even today when I am confined to bed for the third straight day this week.

Toni has taught me to accept the reality of whatever is happening, to detach from unhealthy desire, and to recognize that even the worst year of my life was not permanent. Being able to separate myself from my burning wants and do-not-wants, even for a moment, brings relief. It helps me be compassionate towards my body, working so hard to keep me going. It buffers the pain of disappointment and fear, and reminds me to focus on what matters most. And like every spiritual practice, it takes practice. I must detach, then detach again, then remind myself to detach again. Trying to govern my completely crazy mind is frustrating, but also an opportunity for hope. If I cannot detach in this moment, I can try again in the next.

 

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My Feedback to the Institute of Medicine

Posted on December 19, 2013 by Jennie Spotila

Today, I submitted the following letter to the Institute of Medicine with my feedback on the panel for the Diagnostic Criteria for ME/CFS. Seven other advocates signed the letter: Chris Heppner, Claudia Goodell, Joe Landson, Denise Lopez-Majano, Matina Nicholson, Darlene Prestwich, and Tamara Staples.

Thank you for this opportunity to provide feedback on the Institute of Medicine’s provisional committee appointments for the Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. In order to understand the significance of my concerns, I believe you must first understand the damaging legacy of the psychogenic view of ME/CFS. Then I will share my specific feedback about the panel’s composition.

Legacy of Psychogenic Explanations for ME/CFS

For more than thirty years, the psychogenic model dominated the medical mainstream view of ME/CFS. Patients were labeled malingerers with “yuppie flu.” Allegedly, they could not cope with stress, indulged their psychosomatic symptoms, received secondary gain from disability, and simply needed to get therapy and more exercise. I have never met an ME/CFS patient who did not receive this message from at least one doctor.

Through the 1990’s, science seemed to confirm this model. Every investigation for a causative infectious agent failed. Contradictory results prevented the validation of diagnostic biomarkers. And psychologists published data showing that cognitive behavioral therapy and graded exercise therapy produced positive outcomes.

But ME/CFS patients, expert clinicians, and some researchers knew that the data were flawed. Mixed patient cohorts likely contributed to many of the contradictory results. Many of us followed the advice of well-meaning healthcare providers and tried to exercise ourselves out of disease. This therapy was not a treatment, and adverse side effects included relapse, exacerbation of the disease, and increased disability.

Science soon emerged to confirm what we knew empirically. Studies showed that ME/CFS patients have different physiological responses to activity as compared to multiple control groups.(1) Many body systems are implicated in the causation and perpetuation of ME/CFS. Field-testing of multiple case definitions measured what we already knew to be true: that some case definitions incorporated people with primary psychological conditions like depression, along with missed cases of multiple sclerosis, lupus, thyroid disease and primary sleep disorders. (2) Given the ample data showing physiological differences between ME/CFS patients and patients with depression and other illnesses, the inclusion of subjects with primary depression in CBT and GET trials is a fatal flaw in study design.

The psychogenic model of ME/CFS should have faded into obscurity by now. But it persists in open supporters of the hypothesis, and in less overtly expressed attitudes among scientists, doctors, and policy makers. Our long experience with the destructive effects of psychogenic pronouncements has taught us to be wary of these unseen and unvoiced assumptions.

Insufficient Representation of Subject Matter Experts

I acknowledge the selection of seven well-known and well-regarded ME/CFS experts to the panel. I am confident in their individual and collective abilities to examine the data and share their experience with the full group. However, given the nature of the panel’s task, I believe that more ME/CFS experts should be added to the panel.

In creating “evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians,” the panel needs both fresh examination of the data by outsiders and consideration of the collective experiential knowledge of those who know this disease. Research and clinical care in ME/CFS has typically been small-scale and distributed widely among the people doing this work. Only when a critical mass of experts combines their knowledge, such as at the NIH ME/CFS State of the Knowledge Workshop in 2011, do the disparate themes come together in a cohesive picture.

My concern is not a numbers game with the goal of reaching a certain percentage of representation. The panel is missing key expertise:

  • First, the absence of a cardiologist is notable. While Drs. Keller, Lerner and Rowe have relevant experience, dysautonomia is too prevalent in ME/CFS for it to be only marginally addressed. Adding a panelist with expertise in postural orthostatic tachycardia syndrome, vasovagal syncope, and/or neurally mediated hypotension is appropriate. I suggest Julian M. Stewart, M.D., Ph.D. or Marvin S. Medow, Ph.D., both at the Center for Hypotension, New York Medical College.
  • Second, there is only one infectious disease specialist on the panel. This is a significant gap in expertise, given the unsuccessful hunt for a causal pathogen in a disease that has all the hallmarks of an infectious trigger. Dr. Martin Lerner is capable, but I suggest adding at least one more infectious disease specialist. Ian Lipkin, M.D., is Director of the Center for Infection and Immunity at Columbia University. An epidemiologist by training, Dr. Lipkin is known for detection of new pathogens and the role of infection in neurologic diseases. He also has experience in ME/CFS-related research. Another candidate to consider is Jose G. Montoya, M.D., Director of the Stanford ME/CFS Initiative and Professor of Medicine in Infectious Disease at Stanford University Medical Center. Dr. Montoya is a clinician-researcher in ME/CFS and also studies the role of infection in chronic disease.
  • Third, as the FDA recognized in their Voice of the Patient report, cognitive problems are a prominent part of ME/CFS. Gudrun Lange, Ph.D. of Beth Israel Medical Center is an expert in cognitive dysfunction in ME/CFS, and would be a strong addition to the panel.

Finally, the absence of psychologist Leonard Jason, Ph.D. from the panel is very troubling. As I am certain you are aware, Dr. Jason has done more work on field-testing ME/CFS case definitions than any other individual. His publications have demonstrated the inadequacies of the Fukuda and Oxford definitions, the correlation between more symptoms and psychopathology in the ME-ICC definition, and have shown that measuring frequency and severity of symptoms distinguishes patients with ME/CFS from those with fatigue alone. (3)

I recognize that one or more of the individuals I am recommending may be unwilling or unable to serve on the IOM panel. I urge you to harness their expertise in other ways. This is particularly true for Dr. Jason. If he cannot serve on the panel, I believe it is essential that he be invited to present to the committee and that his work be a significant part of the panel’s deliberations.

Investigating Bias in Three Panel Members

I believe that three members of the provisional panel may have bias that would preclude their service on the committee. I understand that the IOM’s Conflict of Interest policy bars individuals with bias from panels only when “unwilling, or reasonably perceived to be unwilling, to consider other perspectives or relevant evidence to the contrary.” (IOM Conflict of Interest Policy, p. 4). I also acknowledge the difficulty of assessing bias at a distance. Therefore, I request that IOM discuss and thoroughly consider the potential biases of these three panelists.

First, Dr. Margarita Alegria co-authored a paper on the prevalence and comorbidity of neurasthenia.(4) While this paper did not directly examine the potential overlap between ME/CFS and neurasthenia, I am troubled by the statements on page 1742 that CFS is “a controversial illness which has been argued to be a variant of neurasthenia,” and that individuals “may present with symptoms of neurasthenia, but may otherwise be misdiagnosed as having depression, anxiety, or CFS.” If Dr. Alegria believes that ME/CFS is actually a psychological condition such as neurasthenia, then her presence on the panel is unacceptable. I urge IOM to establish whether Dr. Alegria has such a bias, and remove her from the panel if she does.

Second, Dr. Theodore Ganiats has close ties to the American Academy of Family Practitioners. The AAFP has published inaccurate and incomplete material about ME/CFS as recently as 2012. (5) In fact, the AAFP’s material on CFS illustrates the outdated and incorrect view of ME/CFS that I discussed above, including the claim that childhood trauma raises the risk of the disease and that CBT and GET are effective treatments. (6) Furthermore, one of Dr. Ganiats’s close colleagues, Dr. William Sieber, has given presentations in which he has stated that CFS is caused by psychological problems. (7) IOM should establish whether Dr. Ganiats shares this psychogenic bias and whether he can truly consider the evidence to the contrary.

Third, Dr. Cynthia Mulrow led the last systematic evidence review on chronic fatigue syndrome conducted by the Agency for Healthcare Research and Quality in 2001. Her report stated, “The validity of any definition is difficult to establish because there are no clear biologic markers for CFS, and no effective treatments specific only to CFS have been identified.” (8) If Dr. Mulrow still believes that this is the test for establishing the validity of a definition, then she is not appropriate for this panel. The lack of “clear” biomarkers and specific effective treatment is due to the paucity of research funding. Many promising biomarkers and treatments need only sufficient investment to establish their validity. Furthermore, Dr. Mulrow’s 2001 article on the treatments for CFS states that there was no significant association between case definition used and treatment study outcome. (9) We now know that some case definitions select patients with psychological problems at a higher rate than others, and this must be accounted for in the panel’s analysis. Absence of evidence is not evidence of absence, and everyone on the panel must realize this. Given Dr. Mulrow’s 2001 publications in support of CBT and GET, and the risk of her inability to fairly consider all the evidence, IOM should establish whether she has an entrenched bias.

Conclusion

I acknowledge that I was among the ME/CFS advocates who vigorously opposed the contract with IOM when it became public in September 2013. I remain skeptical of whether the committee’s report will lead to better diagnosis and treatment for all the people suffering from this debilitating disease.

I urge IOM to add more ME/CFS experts to the panel, such as Dr. Stewart, Dr. Medow, Dr. Lipkin, Dr. Montoya, Dr. Lange, and Dr. Jason. All of these scientists will contribute knowledge that is essential to the panel’s task. I further urge IOM to thoroughly investigate and establish whether Dr. Alegria, Dr. Ganiats, and Dr. Mulrow have biases that should disqualify them from service.

Sincerely, and on behalf of the undersigned,

Jennifer M. Spotila, J.D.
Writer, occupycfs.com

Chris Heppner, Ph.D.
Vice President ME Victoria, BC

Claudia Goodell, MS
Patient Advocate- Race to Solve CFS

Joseph D. Landson
ME/CFS Patient and U.S. Navy veteran

Denise Lopez-Majano
Speak Up About ME
Parent, caregiver, advocate

Matina Nicholson
Patient Advocate

Darlene Prestwich
Patient Advocate

Tamara C. Staples
Patient, 15 Years
Patient Advocate, 5 Years

References:

(1) Light, AR, Bateman L, Jo D, Hughen RW, VanHaitsma TA, White AT, & Light KC. Gene expression alterations at baseline and following moderate exercise in patients with Chronic Fatigue Syndrome and Fibromyalgia Syndrome. Journal of Internal Medicine, (2011) 271(1), 64–81.

(2) Jason LA, Najar N, Porter N, & Reh C. Evaluating the Centers for Disease Control’s Empirical Chronic Fatigue Syndrome Case Definition. Journal of Disability Policy Studies, (2009) 20(2), 93–100.

(3) Jason LA, Sunnquist M, Brown A, Evans M, Vernon S, Furst J, Simonis V. Examining case definition criteria for chronic fatigue syndrome and myalgic encephalomyelitis. Fatigue: Biomedicine, Health & Behavior, Epub ahead of print, accessed Dec 11, 2013: http://www.tandfonline.com/doi/abs/10.1080/21641846.2013.862993?journalCode=rftg20&#.UrEQ0Y06Kw8

(4) Molina K, Chen C, Alegria M, Li H. Prevalence of neurasthenia, comorbidity, and association with impairment among a nationally representative sample of US adults. Soc Psychiatry Psychiatr Epidemiol (2012) 47:1733-1744.

(5) Yancey J & Thomas S. Chronic Fatigue Syndrome: Diagnosis and Treatment. Am Fam Physician. 2012 Oct 15: 86(8): 741-746.

(6) http://www.aafp.org/afp/2012/1015/p741-s1.html accessed December 16, 2013.

(7) Sieber, William. Calming the Anxious Brain, accessed December 16, 2013. http://www.innersolutionsforsuccess.com/PPT/CalmingAnxiousBrain_Oct_2013.pdf.

(8) Mulrow CD, Ramirez G, Cornell JE, et al. Defining and Managing Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No. 42). AHRQ Publication No. 02-E001. Rockville (MD): Agency for Healthcare Research and Quality; October 2001.

(9) Whiting P, Bagnall AM, Sowden AJ, Cornell JE, Mulrow CD, Ramirez G. Interventions for the treatment and management of chronic fatigue syndrome: a systematic review. JAMA. 2001 Sep 19;286(11):1360-8.

 

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IOM Panelists: TL; DR

Posted on December 18, 2013 by Jennie Spotila

I realize that the past two weeks have been a veritable blog-alanche here at Occupy CFS. There’s been more research and writing here on the IOM ME/CFS panel than any other place online of which I am aware. I know that it’s very hard to get through so much material, and several people have requested the Too Long, Didn’t Read version of all the posts in a single list. I’m happy to oblige!

  • The IOM panel was announced on December 3, 2013. (see official roster)

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  • I worked with nine other advocates to research each panelist. (see our methods)

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  • We all had different views of how/whether to participate in the IOM process, but we set our differences aside to collaborate on this project.

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  • We found no conflicts of interest, as strictly defined in the IOM’s policies.

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  • We had a difference of opinion on whether things like NIH funding or other interests constituted a conflict of interest. (see our summary on COI and overall balance)

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  • We agreed that there are not enough ME/CFS experts on the panel.

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  • We do not categorically reject the presence of any psychologist/psychiatrist on the panel. After all, we all want Dr. Leonard Jason on the panel and he is a psychologist.

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  • Dr. Ellen Wright Clayton, chair of the panel, has a JD/MD and specializes in ethics of genetic screening and research. (see our writeup of the “unknown” panelists)

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  • Dr. Margarita Alegria is a psychologist specializing in mental health research in multicultural populations. We have serious concerns that she may believe ME/CFS is a psychological condition. (see our writeup on her bias)

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  • Dr. Lucinda Bateman is an ME/CFS expert clinician-researcher, with a large ME/CFS clinic. (see our writeup on the “known” panelists)

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  • Dr. Lily Chu is a clinician-researcher whose career has been hijacked by ME/CFS.

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  • Dr. Charles Cleeland is a psychologist specializing in cancer pain and qualitative measures.

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  • Dr. Ronald Davis is a renowned geneticist, and has a close family member with ME/CFS.

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  • Dr. Betty Diamond is a rheumatologist specializing in lupus.

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  • Dr. Theodore Ganiats has expertise in family medicine and healthcare outcomes. We have serious concerns about his close ties to the AAFP and a colleague who has said that ME/CFS is a psychological condition. (see our writeup on his bias)

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  • Dr. Betsy Keller is an exercise physiologist studying ME/CFS.

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  • Dr. Nancy Klimas is an ME/CFS expert clinician-researcher, with expertise in immunology and a large clinical practice.

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  • Dr. Martin Lerner is an ME/CFS expert clinician-researcher, specializing in infectious disease. He is also a recovered ME/CFS patient.

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  • Dr. Cynthia Mulrow is an expert on systematic reviews. We have serious concerns about her bias based on two CFS publications in 2001. (see our writeup of her bias)

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  • Dr. Benjamin Natelson is an ME/CFS expert clinician-researcher and neurologist.

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  • Dr. Peter Rowe is an ME/CFS expert clinician-research, with one of the largest pediatric ME/CFS practices in the country.

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  • Dr. Michael Shelanski is a cell biologist specializing in Alzheimer’s disease. We are puzzled about his presence on the panel.

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  • You have until December 23rd to submit feedback to IOM about the panel. (see how to do that here)

 

Once again, I have to acknowledge the group effort that made this series of blog posts possible: Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous. My sincere thanks to them all.

 

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IOM Panelists: Submitting Feedback

Posted on December 18, 2013 by Jennie Spotila

Feedback to the Institute of Medicine on the provisional committee appointments for the ME/CFS clinical definition study is due December 23rd.

Not everyone in the advocacy community believes submitting feedback is appropriate. But if you wish to provide any input on the panelists, or on people you think should be added to the panel, there are two ways to do so.

  1. Submit feedback through the form on the IOM Committee page. Scroll down to the “Feedback” button at the bottom of the page. The study director, Dr. Carmen Mundaca, told me via email that there is no character limit to the size of your submission.
  2. If you prefer to submit your feedback as an attachment, you can do so by emailing it to mecfs@nas.edu.

I asked Dr. Mundaca if feedback is viewable by the public. She said that some feedback related to the overall balance of the panel might be placed into the “Public Access File,” a collection of documents viewable by the public. But not all feedback submitted will go into that File, so this is not like the public docket system many people used for the FDA April meeting.

Remember, all comments are due December 23rd!

 

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IOM Panelists: Balance = Experts + Information – Bias

Posted on December 16, 2013 by Jennie Spotila

The issue on everyone’s mind is whether the Institute of Medicine panel is the right group to come up with a new ME/CFS clinical case definition. Our team has been debating this for nearly two weeks now, and we have not reached a unanimous conclusion. But our research and discussions illuminate some key issues, particularly on the inclusion of psychologists and the possibility of bias in three panelists.
 

Enough Experts?

 
The overall panel balance is 53% known and 47% unknown to the ME/CFS community. None of us think this is sufficient, but we do not agree on what the right split would be. Some of us think the panel should be 100% ME/CFS experts; others think the addition of at least one or two more experts would be appropriate.

Mary Dimmock has raised a very important point: in order to judge whether this panel is adequate, we have to think about the task. If this panel is going to create a case definition for the broader set of conditions that meet the various CFS criteria, then some might make the argument that this panel is appropriate. But if the panel is focused on the disease we described to the FDA in April, then Mary concludes that the panel needs more, and a broader cross-section, of ME/CFS experts and fewer psychologists. As Mary has reported, HHS and IOM have been vague in detailing which disease group is the focus of the panel.

We’re faced with a chicken-egg dilemma: identifying the disease focus should happen prior to the panel selection, but instead we have a panel with a seemingly vague task focus. This panel composition seems to hold a middle ground: there are not an overwhelming number of ME/CFS experts, but neither are there an overwhelming number of experts in unexplained chronic fatigue, psychogenic models, or “other multi-symptom, complex disorders” as described in the Statement of Work. To our team, the key issue is bias.
 

Psyched Out

 
There are two psychologists on the panel: Dr. Margarita Alegria and Dr. Charles Cleeland. None of us are particularly troubled by Dr. Cleeland, as the focus of his career has been chronic pain (a significant problem for many ME/CFS patients) and outcomes measures. Dr. Alegria is another story, as discussed in the next section.

In a comment on an earlier blog post, AJ asked if panels on other diseases have included psychologists or psychiatrists. We did some research into the question, and found mixed results:

  • Psychologists/psychiatrists were included in panels on treatment for Gulf War Illness (5 of 15), epilepsy (3 of 17), living with chronic illness (3 of 17), chronic pain (5 of 19), and breast cancer and the environment (1 of 15).
  • No psychologists/psychiatrists were included in panels on Gulf War and infectious disease, veterans and Agent Orange, cardiovascular and chronic lung disease, hypertension, hepatitis and liver cancer, and ALS in veterans.
  • The only other IOM panel creating a case definition, the case definition for chronic multisymptom illness (aka GWI), includes 3 psychologists/psychiatrists out of 16 total members.

The ME/CFS panel includes 2 psychologists out of 15 total members.  Creating a case definition for ME/CFS will involve confronting the psychosocial literature and assessing its validity. For this reason, we do not categorically reject the presence of psychologists on the panel. However, we have serious concerns about psychologists who are ignorant of the methodological flaws in much of that literature. We are also concerned about the bias Dr. Alegria may bring to the task, and explore that in more detail below.
 

Bad Bias vs. Good Bias

 
The IOM Conflict of Interest Policy does not bar individuals from serving just because they have adopted positions on the issues facing the panel. In fact, the policy admits that members with potential biases might be necessary to ensure a competent and balanced panel. Bias will preclude committee service when “one is totally committed to a particular point of view and unwilling, or reasonably perceived to be unwilling, to consider other perspectives or relevant evidence to the contrary.” (p. 4)

There are multiple panelists with potential bias. For example, Drs. Bateman, Chu, Keller, Klimas, Lerner and Natelson have all taken public positions on ME/CFS case definitions. At least one team member personally knows each of these individuals, so we believe we can say that none of them are unwilling to consider other perspectives or relevant evidence.

Of greater concern to our team are three unknown panelists who may have biases that could be very harmful to the interests of the ME/CFS community. It can be challenging to assess bias at a distance based on publications, but we have legitimate concerns about three panelists: Dr. Alegria, Dr. Theodore Ganiats, and Dr. Cynthia Mulrow.

Dr. Alegria

As we mentioned in our profile of Dr. Alegria, she has co-authored three publications potentially relevant to her views on ME/CFS. The first two (here and here) address the relationship between somatic symptoms and psychiatric disorders like depression. Only 14 symptoms were assessed in these papers, and fatigue was not one of them. The papers found that having 3 or more of the 14 symptoms was associated with depression/anxiety and mental health service use. However, one of the papers correctly noted that the data are ill suited to infer causality between the physical symptoms and mental health issues.

After examining the third paper in its entirety, we came to mixed conclusions about whether it represents unreasonable bias on Dr. Alegria’s part. The paper builds on previous research showing that neurasthenia has the highest rate of comorbidity among ICD-10 disorders, and examines whether prevalence and comorbidity rates hold up across racial/ethnic groups. Comorbidity was examined only in depressive, anxiety and substance abuse disorders. Space does not permit a full parsing of the data here, including significant methodological limitations. Although the paper itself does not directly examine the relationship between neurasthenia and CFS, statements about CFS included in the paper have caused serious concerns among advocates. We carefully considered the statements and whether these are indications of unreasonable bias.

Likewise, as Lee [51] argued, the ‘‘disappearance’’ of culture-bound syndromes is related to changing sociocultural conditions, including economic and political factors and changes in managed care and pharmaceutical forces, to name a few. Indeed, chronic fatigue syndrome (CFS), also a controversial illness which has been argued to be a variant of neurasthenia [4, 21] has become increasingly diagnosed in the US [52, 53], whereas neurasthenia is virtually no longer diagnosed in the US context [51].

Many advocates are correctly concerned about the statement above that CFS is “a controversial illness which has been argued to be a variant of neurasthenia.” The first reference is to a thoroughly offensive article from 1991 that argued that CFS is a culturally sanctioned form of illness behavior.  The second reference is from 2007, but examined the concordance of CFS and three neurasthenia criteria in four medical practices in Pune, India. Neither reference can legitimately be used to support the statement that CFS should be seen as a variant of neurasthenia today.

After noting again that neurasthenia has almost disappeared from US clinical practice, the paper states:

This has implications for diagnosis and treatment of individuals who may present with symptoms of neurasthenia, but may otherwise be misdiagnosed as having depression, anxiety, or CFS.

This sentence can be read two ways. In one interpretation, neurasthenia patients are misdiagnosed with depression, anxiety or CFS because “neurasthenia” is not used in the US, and this does not imply that CFS as an entity is actually neurasthenia. In the second interpretation, people are diagnosed with CFS incorrectly because CFS is actually neurasthenia. Depending on which interpretation you choose, Dr. Alegria’s presence on the panel can be quite alarming, as she may have a simplistic, outdated view of ME/CFS or worse. But other team members see these few sentences in the paper within the context of Dr. Alegria’s research focus, which does not appear to reflect a tendency to classify patients with diagnosable physical conditions as having mental disorders.

Regardless of our personal interpretations of the meaning of these three papers, we all share a strong concern about her presence on the panel. She seems to have little experience relevant to an ME/CFS case definition at best, and potentially disastrous views if she does in fact believe that the physical symptoms of ME/CFS are equivalent to neurasthenia. Given the damaging legacy of psychogenic approaches to ME/CFS, we believe that her potential bias must be thoroughly investigated before the panel is finalized.

Dr. Ganiats

In our profile of Dr. Ganiats, we noted that Dr. Ganiats himself has not published anything directly indicating a bias on ME/CFS. However, he has been very closely associated with the American Academy of Family Practitioners. The AAFP has published problematic material about ME/CFS as recently as 2012. The AAFP’s consumer health information site presents a simplistic view of CFS, including the statement that “Most symptoms improve with time,” which is patently untrue, as many of us can personally attest.

We also noted Dr. Ganiats’ close association with colleague Dr. William Sieber. Dr. Sieber is a psychologist who has given presentations claiming that CFS symptoms are due to psychological problems. Dr. Ganiats has also published a number of papers on “quality of well-being” with Dr. Robert Kaplan, the Director of NIH’s Office of Behavioral and Social Sciences Research. We are wary of assuming bias by association, but Dr. Ganiats’s connections raise the possibility that he may have an outdated view of ME/CFS as merely fatigue of potentially psychogenic origin.

One team member suggested that Dr. Ganiats adds little to the panel as a general practitioner, especially since Dr. Bateman was a general practitioner for many years prior to opening her Fatigue Consultation Clinic. On the other hand, Dr. Ganiats brings his close relationship with AAFP and his experience in doctor-patient decision making to the table. But if Dr. Ganiats shares the views of AAFP or Dr. Sieber on ME/CFS, then he may have a strong bias towards the psychogenic view, or may at least be predisposed to broader views of the illness. This bias is unacceptable, and should be thoroughly considered by IOM before the panel is finalized.

Dr. Mulrow

Some readers took issue with our statement that Dr. Mulrow’s experience on IOM and in systematic reviews made her “very qualified to tackle the massive systematic evidence review that will be part of the IOM ME/CFS study.” And if her experience with IOM and reviews were the only question, that statement would be accurate on its own. However, as noted in our original profile, she has publications on ME/CFS that give us great pause.

Specifically, Dr. Mulrow led an evidence review on CFS in 2001 that concluded, in part, “The superiority of one case definition over another is not well established. The validity of any definition is difficult to establish because there are no clear biologic markers for CFS, and no effective treatments specific only to CFS have been identified.” It’s arguable whether this was true in 2001, but we certainly hope her view is different now.

Dr. Mulrow also co-authored a paper on treatment interventions in CFS in 2001 and based in part on that AHRQ review. Based on 2001 evidence, CBT and GET were considered promising treatments, despite some high drop out rates and lack of concrete outcome measures.

While the paper does say that effectiveness must be considered in light of those methodological issues, the analysis of these studies seems rather forgiving. The presence of multiple methodological problems did not preclude the studies being treated as highly valid. This points to potential risks in evidence-based medicine and meta-analysis approaches. The protocol for the review is established in advance, but if it is overly simplistic or has low inclusion criteria, the results of the review will reflect that lack of rigor.

Several team members feel very strongly that Dr. Mulrow is a potential problem on the panel precisely because of her systematic review expertise. They are willing to accept that she may bring an open perspective to ME/CFS itself, but fear that her process approach is ill-suited for an area that has been consistently underfunded for decades leading to an overemphasis on cheap (possibly less rigorous) science. Other team members feel that systematic review experience is necessary to help un-bias the view of the literature by setting evaluation criteria in advance. But again, if she is unwilling to approach the field as it is today then this is a problem.
 

Hiding in Plain Sight

 
There is one panelist who continues to stump us: Dr. Michael Shelanski. As we described in the original profile, he is a a pathologist focused on cell biology and animal models in Alzheimer’s disease. We don’t doubt his credentials in that field, but we fail to see how relevant that experience will be to creating a case definition for ME/CFS

Several big names in ME/CFS are missing from the IOM panel. The biggest head scratcher is Dr. Leonard Jason, who received at least seven nominations from the ME/CFS community. Dr. Jason is the authority on ME/CFS definition assessment and comparison. If he cannot serve on the panel for any reason, then his expertise must be harnessed by the panel another way.

The absence of infectious disease experts besides Dr. Lerner is another disappointment. Dr. Ian Lipkin and Dr. Jose Montoya each received at least five nominations. Dr. Lipkin is currently researching evidence for pathogens in ME/CFS, while Dr. Montoya is a clinician-scientist at Stanford University who spoke on a panel at the April FDA meeting. Either would be a strong addition to the panel to build on Dr. Lerner’s experience.

Dr. Christopher Snell received at least seven nominations, and is the leading expert on exercising testing in ME/CFS. But Dr. Keller is an adequate replacement, given her familiarity with Dr. Snell’s techniques and her own growing expertise in working with ME/CFS patients.

The IOM did not appoint a cardiologist or endocrinologist to the panel, and this is a disappointment. Cardiac and endocrine abnormalities have been part of the ME/CFS picture for decades, and both were listed in the Statement of Work (although not as requirements). While Dr. Natelson is a neurologist, inclusion of a researcher specializing in cognitive impairments in ME/CFS would also be advisable.
 

A Final Step

 
Feedback on the provisional panel is due December 23rd. Our next post will include the feedback we intend to submit, and we hope that other advocates will also participate in whatever way they believe is appropriate.

 

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.

 

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IOM Panelists: Balancing Act

Posted on December 13, 2013 by Jennie Spotila

753625-seesaw_square_largeThere is a good deal more to discuss about the Institute of Medicine ME/CFS case definition panelists beyond their individual backgrounds (see the known and unknown panelists’ profiles). Our team has been grappling with those issues, not always achieving consensus. We hold a spectrum of opinions, and it forms an important context for providing feedback to IOM on the panel.

The Moral Question

The reasons for the ME/CFS community’s opposition to the IOM study have been extensively explored over the last three months. Part of the struggle has been over what to do about it. Some advocates believe we should contribute to the process in a constructive way by providing feedback on the panelists and input on the substantive issues. Others believe that participation in the process is not only pointless, but will actually legitimize an illegitimate process. They advocate unconditional and complete resistance to the IOM study, and state that no advocate should provide feedback on the panel. There are other views as well, and everyone is entitled to act on their views as they see fit.

Our team has mixed views on this question of involvement in the process. Several members lead organizations that have publicly stated their support for participation. Others struggled with whether to be involved in our research project, let alone in providing feedback to IOM. Obviously, given the intense investment of time and energy we have made, the ten of us believe there is value in examining the panel. Information is powerful, and one must first have that information in order to make effective use of it.

Conflicts of Interest

As I explored in a previous blog post, the IOM takes issues of conflict of interest (COI) and bias very seriously. In fact, a large portion of the panel’s first meeting will be spent discussing potential conflicts. Our team struggled with how to define COI and apply that definition to this panel.

The IOM defines a COI as “any financial or other interest . . . [that] (1) could significantly impair the individual’s objectivity or (2) could create an unfair competitive advantage for any person or organization.” In researching the panelists’ background, we looked for clear financial interests that could affect a person’s judgment on the ME/CFS case definition. For example, if a panelist had received payments from a disability insurance company, we believed that would be a clear conflict. We didn’t find anything like that.

Our team also discussed other financial interests and the potential effect on panelists. For example, many panelists receive government funding (chiefly NIH and Department of Defense), and we also found that some have received significant research or consulting fees from pharmaceutical companies. Does this funding represent a conflict of interest? Some team members believe that it does, in that a panelist would be more likely to do what the government wants because he/she feared losing future funding. The IOM policy specifically limits COI to current – not future – financial interests, but that did not reassure these team members.

The counter-argument is that if receiving NIH funding is a conflict of interest then almost all of the panelists – including the ME/CFS experts – would be disqualified. Dr. Klimas and Dr. Natelson receive significant NIH and/or DoD funding for their work. One team member felt that in their cases, the interests of their patients would outweigh the government’s potential influence through funding, but others were concerned about creating these sorts of exemptions.

How far does this go? If having an ME/CFS clinical practice is such a strong influence, what of panelists like Dr. Bateman or Dr. Lerner? They do not receive NIH funding as principal investigators (although they may be co-investigators), but do they have a conflict of interest because they earn a living from ME/CFS patients? And what about the influence of CDC? Dr. Bateman, Dr. Klimas and Dr. Natelson are all participating in the CDC’s multisite study. Dr. Bateman, Dr. Natelson and Dr. Rowe have recently appeared in the CDC’s physician education programs. Furthermore, there are two panelists who will be personally and directly affected by the panel’s recommendations. Dr. Chu is a patient herself and Dr. Davis’s son is very ill. Any new case definition will have a direct impact on their lives. Does that mean they have a conflict of interest?

The challenge in assessing conflict of interest is to apply the definition evenly in all cases. If NIH funding is a COI, then everyone with such funding is out. If treating ME/CFS patients is a powerful influence on a panelist, then all those doctors are out. After much discussion, the majority of the team believed that things like NIH funding and clinical practice were not conflicts of interest. In addition, the IOM policy specifically allows panelists with COI to serve if they have unique and necessary qualifications. We believe that the points of view of patients are critical to this panel’s work, and therefore patient or family status should not be a bar to service.

Committee Balance

Selecting the IOM panel is not just a matter of individual expertise, but also the overall balance of viewpoints. Do the panelists’ views balance each other out, with no particular view dominating? Will they collectively be able to discuss and consider the full spectrum of issues?

The IOM Statement of Work listed the desired committee expertise. How well does this panel address that?

  • pathophysiology, spectrum of disease, and clinical care of ME/CFS (Bateman, Chu, Keller, Klimas, Lerner, Natelson, Rowe)
  • neurology (Natelson, and potentially Shelanski)
  • immunology (Diamond, Klimas, Natelson)
  • pain (Cleeland)
  • rheumatology (Diamond)
  • infectious disease (Lerner)
  • cardiology (no cardiologists, although Keller, Lerner, and Rowe have relevant experience)
  • endocrinology (none)
  • primary care, nursing, and other healthcare fields (Ganiats, Bateman, Alegria)
  • health education (Bateman, Ganiats, Klimas, Rowe)
  • and the patient/family perspective (Bateman, Chu, Davis, Lerner)

One member has experience in systematic reviews (Mulrow), and another has extensive experience in outcomes measures (Cleeland). Two or three may potentially take a behavioral view of ME/CFS (Alegria, Ganiats and Mulrow), but at least six can speak directly to pathophysiology (Bateman, Chu, Klimas, Lerner, Natelson and Rowe). Six panelists have co-authored previous ME/CFS definitions and/or adopted a public position in support of CCC (Bateman, Chu, Keller, Klimas, Lerner, and Natelson), and five currently treat ME/CFS patients (Bateman, Klimas, Lerner, Natelson and Rowe). At least two panelists appear to have no prior knowledge of ME/CFS (Clayton and Shelanski).

Some team members do not want any psychologists on the panel regardless of their backgrounds, and a few felt that the panel should be made up completely of ME/CFS experts. Others felt that bringing in non-ME/CFS experts has advantages. All of us are concerned about the views of Alegria, Ganiats, and Mulrow. The absence of a cardiologist and endocrinologist are unfortunate, but hopefully at least part of that angle can be covered by the ME/CFS experts.

Overall, the committee membership seems fairly balanced. There is diversity of professional experience and of ME/CFS specific experience. While all of us would have liked to have seen more ME/CFS specialists, it is important to note that we have confidence that the specialists on the panel are fully capable of conveying their points of view. We don’t expect that Drs. Bateman, Chu, Keller, Klimas, Lerner, Natelson or Rowe are likely to be bullied; indeed, many of us have personally witnessed their willingness to speak their minds.

Next Steps

The IOM is accepting feedback on the provisional panel until December 23rd. Many, if not all ten of us, hope to provide such feedback. We are looking more carefully into several of the panelists, and will share our assessment in a future post.

 

Acknowledgements: This post was a group effort, and would not have been possible without the assistance and participation of Lori Chapo-Kroger, Claudia Goodell, Chris Heppner, Denise Lopez-Majano, Mike Munoz, Darlene Prestwich, Tamara Staples, WillowJ, and one advocate who wished to remain anonymous.

 

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(Lack of) Progress Report

Posted on December 12, 2013 by Jennie Spotila

thumbs-downThe December 2013 CFS Advisory Committee meeting was controversial before it began, and honestly things only went downhill from there. I don’t think I have it in me to list everything that was wrong with the meeting, and I’m pretty sure you don’t want to read that whole list either. Let’s just focus on the lowlights: the tech, the wreck, and the waste.

The Tech

Let’s just set aside the challenges of webinar format. Let’s set aside Dr. Marshall’s valiant effort to make this meeting productive. Let’s even assume that the tech folks knew what they were doing. There is more than enough left to criticize.

There was no audio via the computer. You could see the slides, but that’s it. To hear the meeting, you had to call in. Of course, that was not clear in the meeting instructions, and so the public spent 15-20 minutes just trying to figure out what we needed to do to hear anything. There is no excuse for this. I’ve attended at least a dozen meetings using Adobe Connect. I can always get audio through my computer. I’m not aware of any technology limitation that prevented them from providing audio through the computer yesterday. Many patients rely on their cell phones and did not have five hours of minutes to burn to listen to the meeting. Others are not capable of holding a phone for more than a few minutes. And some are limited to dial-up, which means they can use the internet or the phone – not both. This webinar was inaccessible for too many people.

Next slide, please. Jeannette Burmeister said on Facebook:  Someone on Facebook (not sure if she wants her name associated with this publicly) “The words of the day: Can I have the next slide, please? Next slide? Next slide? Hello? Can anybody hear me? Can I have the next slide?” During the research working group presentation, there were several minutes lost to a back and forth about advancing the slides during which Dr. Lee pointed out that she could advance the slides but that no one else was seeing it. The episode culminated in something along the lines of “Take your hands off your mouse and let Paul advance the slides.” Yes, there are always technical glitches and problems with slides – all the time. And if this was the only glitch in the meeting, we would not even be commenting on it. But here’s my question: Why did they not rehearse who would control the slides (and how) in advance!!!???!!!!!!

So much dead air. The high-fluster episode of the day was public comment. Dr. Lee was not able to conference telephone commenters in. This resulted in 3 to 5 minutes of dead air prior to every comment. Dr Marshall tried to manage this – asking for patience, promising to get everyone in despite the loss of time, calling the break early to give them a chance to fix it. When my turn came, I was interrupted twice because my comments were not being broadcast, told to hang up twice so they could attempt to reconnect me, etc etc etc. Again, and I’m sorry for shouting, BUT WHY WAS THIS NOT REHEARSED IN ADVANCE?

Check Yourself, Before You Wreck Yourself

Thanks to Angel Mac and Lisa Petrison, we have a partial transcript of Dr. Lee’s comments at the end of the discussion on the Institute of Medicine study:

I’ve seen so much vitriol and personal attacks in email and blogs around the IOM study. I don’t see how this will be constructive going forward, given the opportunity before the ME patients and families.

Everyone I know working to make the clinical diagnostic criteria a reality has good intentions and wants to make things better for ME/CFS patients. Implying that IOM staff or committee members don’t have good intentions will not be helpful, and it could backfire.I had patient advocates apologize to me in private – when this happens in a public meeting or blog or email – (lost audio)

From my own notes, I can add that Dr. Lee went on to say that when we see people making these sorts of comments, we should call them out on it. Update to add: Claudia Goodell captured the quote as “Don’t make vitriolic statements that assume IOM panelists have bad intentions in a public forum. Those who do will be called out.”

Do you realize what happened here? A federal employee, acting in her official capacity as Designated Federal Officer of an advisory committee, just told members of the public how to exercise (or not) their First Amendment rights on a subject she personally works on in her official capacity. I was shocked. Perhaps I shouldn’t be, anymore, because every time I think we’ve seen rock bottom we sink further down.

Here’s the thing: ME/CFS advocates are like a family. The only thing we have in common is the disease that binds us together. We don’t always get along. Sometimes we have to fight things out, or tell each other how we’re falling short. And we will never agree on anything. But we can get away with it because of that family tie. We can say things to each other that no one else can say to us.

Dr. Lee, despite her official role with CFSAC, is an outsider to this community, regardless of what you believe about her motives, her capabilities, her decisions, or her personality. As far as I know, Dr. Lee is not one of us. That’s not a criticism; it’s a fact. Dr. Lee is not an ME/CFS patient, has not treated ME/CFS patients, and is not a caregiver for an ME/CFS patient – as far as I know.

It is not Dr. Lee’s place to tell me how to advocate, who to criticize or how to do it. I happen to agree that personally attacking people is counterproductive, but that’s my choice. It was completely inappropriate for Dr. Lee to publicly criticize the advocacy community. She’s free to do that in private all she wants. But her attempt to admonish us in public had the precise opposite effect to the one she intended: now we’re all criticizing her for these inappropriate remarks. Dr. Lee, please, just stop.

Wasted Opportunity, Wasted Time, Wasted Money

I have a very very long list of questions that were not answered yesterday. There were multiple questions that could have been asked during the discussion period, but no one did. For example, don’t we want to know who is serving on the steering committee for the Evidence-based Methodology Workshop? But Dr. Maier didn’t mention it during her NIH report and no one asked her. It was driving me bonkers.

The two workgroups provided interesting presentations, especially the Researcher and Clinician-Scientist Recruitment Workgroup. But because all discussion on NIH, CDC, and the two workgroups was shunted to the end of the day, most of the issues were not explored. That final discussion period was a chaotic mishmash of back and forth between the two workgroup presentations, other tangential issues, at least one minute spent figuring out how to get recommendation text posted (again, rehearsal? anyone?), and a maddening discussion about Wikipedia. The quickly drafted recommendations were not even actual recommendations and, as the group ultimately decided, needed a good deal more development.

Do you know what this meeting actually was? It was a status update. Neither workgroup has finished their charge (which in itself is fine!), although it’s not clear if the education workgroup realized that they needed to be developing some kind of output. The two agency reports were heard but not questioned. The only votes were 1) to allow time at the end for departing member comments and 2) to ask the education workgroup to develop more background for their recommendations. This meeting was a five-hour, taxpayer-funded status report.

Denise Lopez-Majano asked the question of the day in her public comment: if the Office of Women’s Health recognizes the need for an additional 1-2 day webinar meeting in February 2014, why was this meeting held at all? This is why so many of us asked that the meeting be canceled and rescheduled in full. Every aspect of this advisory committee meeting was given short shrift because of the decimation of the allotted time. It was disrespectful to people affected by ME/CFS and to the substantive work of the Committee. I don’t know how much it cost to hold this meeting, and I don’t know how much a cancellation might have cost. But I don’t see how anyone can claim it was worth it. The other investment that has been squandered is the time and effort of so many advocates who have attempted to assist the CFSAC leadership in improving the effectiveness of the Committee.

This meeting accomplished two things: the public airing of the lack of progress across multiple domains and an exponential increase in frustration in the advocacy community. As many people pointed out yesterday, there is a serious disconnect in communications between HHS and the advocacy community. The decision to go ahead with this meeting was a terrible capstone to the precipitous decline in the HHS-advocacy relationship. Unless, as I said in my written comments, “HHS intends to send the message to the ME/CFS community and to you, CFSAC members, that it does not care what we think, it does not want our input, and it does not intend to do anything beyond or better than what it is already doing.”

If that’s the case, mission accomplished.

 

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Ess, CFSAC Testimony, December 2013

Posted on December 12, 2013 by Jennie Spotila

Ess submitted anonymous written comments for the public record. I’m happy to publish her comments in their entirety, using her screen name with her permission.

Introduction

Thank you very much for this most important opportunity to add written comments to the CFSAC webinar for December 10 – 11   , 2013.  In keeping with the guidelines, I state my wish that my comments herein remain ‘anonymous’.  Thank you for that respect.

About Me Personally

Disease – Medical Fixes / Cures

For information purposes, some years prior to being stricken with ME/CFS I have had other serious diseases—an intestinal parasite and Primary Hyperparathyroid disease.  Point being, in both cases of disease there was a medical fix—I was so grateful to get my ‘life back’ – returning to being fully active, healthy and busy in my life both personally and professionally; working full time—and being an active productive member of society.

This experience with serious illness has enabled me to know full well when there is a serious medical problem attacking my body—and my wonderful doctors are there to help me.

There is a stark contrast between a return to good health and, hence, the ability to actively live life fully-functionally in all aspects – and then there is substantial DISability in all aspects of life with ME/CFS—and THAT is what I am talkin’ about.

Healthy and FULL OF LIFE  .    .   .  And Then Along Came ME/CFS

There I was–an active, energetic, athletic person—worked full time—managed the domestic household chores on a day-to-day regular basis—busy active social life with family and friends—free to choose to and able to go on vacation—free to choose to and able to dash out of the house on a whim, at a moment’s notice—on any given day/every day—for ‘anything and everything,’ be it for physical exercise/activity, errands, grocery shopping, socializing, appointments, etc.—then boom—ME/CFS hit—and ALL of the above was taken away—erased—stolen away by the serious illness of ME/CFS.

Good health and an active busy professional, personal, domestic, family and  social life as I knew and ‘lived’—that life is NO more.   The collective we can tend to take our robust healthy active fully-functional lives for granted—as that is our ‘norm’ /’the norm’—we expect to live our lives that way!

I am more than grateful to my good and caring doctors—both family doctor and specialists, and to the dedicated scientists and researchers at home and world-wide striving hard to get to the answers at the core of ME/CFS; using current up-to-date science getting to the roots of ME/CFS as a biological profoundly debilitating disease.

CFIDS On-Line Survey

As you know, CFIDS has put out several on-line surveys to the ME/CFS community.   Some months back I was answering the survey questions—when one particular question, with pre-stated answers that we check in boxes, really got me questioning the survey itself.

Specifically that question was—What keeps you in this disease (i.e. from getting well)?

  • My forthright answer—in the comment section was/is—The FACT that there has been NO scientific medical fix!  

Time Passes Stealing Precious Life Times and Moments Away

Seven years have now passed with being ‘held hostage’ with this debilitating disease of ME/CFS; it is now towards the end of 2013—and that description of a completely altered ‘life with ME/CFS’ remains the same; there is NO improvement.

For the most part I am housebound—seven years now—pushing to get out of the house once a week on an outing—most often an appointment; some weeks getting out of the house does not happen – and then the after-math crash from pushing to use/exert all the energy required for an outing.

I love life; I love the world!

Along with everyday life activities are the fun celebrations in life like weddings and, also, the very tragic life events as in the death of a dear parent.

Unfortunately, because of the ‘chains of ME/CFS’ limiting my activity—I was UNable to take a one hour flight to see my dear beloved father before he died; leaving this life forever.  I call this a TRAGEDY and DEVASTATION—and I want you to know that!

Weddings—what more delight is there!!  There begs a question, however—How will I ever be able to travel/fly across the country to our adult child’s wedding??  Answer—I  WON’T; not possible—won’t happen !

We all know of young couples who have lost the chance and life-privilege of giving birth and raising a family—because of the debilitation of ME/CFS.

And, life continues to go on all around us .   .   . as WE—pw ME/CFS continue to live our daily lives in chronic illness AND in isolation—and as time passes, that time leads to  years and decades of UNlife like this.

Participant in a Research Study on Complex Chronic Diseases re ME/CFS

I am pleased to say that I am a participant in a research study on Complex Chronic Diseases re ME/CFS headed by a large team of Experts/Researchers.  My testing for this phase has been completed, as the study is ongoing.  At a subsequent appointment with my Neurologist, my doctor shared with me that a problem with my mitochondria was identified in this study on Complex Chronic Diseases.  A dictionary definition of mitochondria follows.

  • Mitochondria are the cell’s power producers. They convert energy into forms that are usable by the cell
  • ·      Small spherical or rod like bodies, bounded by a double membrane, in the cytoplasm of most cells:  contains enzymes responsible for energy

A problem with MY mitochondria has been scientifically identified—interesting; very interesting—a basic definition of mitochondria references ‘energy’—and the research testing has found a biological problem with energy—AND I have been (previously) diagnosed with ME/CFS wherein ‘energy’ is a significant biological problem—accounting for substantial diminished level of activity function in  all aspects of daily life.

Recent science shows that there is profound immunological, neurological and metabolic dysfunction in pw ME/CFS.

All through the years, rolling into decades, as well as currently in this labyrinth of getting to the scientific roots and answers to crack the code of ME/CFS—there have been and ARE many dedicated doctors, scientists and researchers working tirelessly to find the answers to this horrid biological disease of ME/CFS; and we cannot applaud them or thank them enough for their never-ending dedication.

Outdated MISinformation

With documented history, over the years and decades, as well as currently there have been and are trivializations, diminishment and DISmissals as to the seriousness of this biological disease called ME/CFS.

The question MUST be asked—Why all the DISrespect, DISregard and MISinformation surrounding ME/CFS?

Recommended default treatments like GET (Graded Exercise Therapy) and CBT (Cognitive Behaviour Therapy) are being thrown at this disease of ME/CFS—which ultimately cause more harm than good.

ME/CFS is NOT a psychiatric disease/disorder; proven to be a known fact.

DENIAL of the critical second day of the stress/activity test that proves exercise intolerance in ME/CFS; see Professor Dr. Kenny de Meirleir—Exercise intolerance occurs primarily after physical exertion.  Two peak exercise capacity tests separated by 24 hours show exercise capacity is reduced after 24 hours in pw ME/CFS—begs the question of WHY—what is the agenda here in denial of the critical second day?  Day 1 ‘only’ will prove .  .  .  nothing!

Let us, together, move forward in the common goal with state-of-art science to get the timely answers to cure people with ME/CFS of this debilitating BIOLOGICAL illness.

A Little More

Importantly to note:  ME/CFS, as debilitating as it is—IS spreading globally; tragically, this disease has been let to spread globally—attacking men, women, young children, teens, adults of all ages.

Being familiar, as we all are here, with the devastation in health and a ‘stolen life’ that comes with ME/CFS, certainly begs the question—How can anyone wish this debilitating chronic disease on anyone, especially on younger people—children and teens—young adults—to live like this in never-ending debilitating ILLness; ME/CFS stealing our/their lives away?? 

By standing by or standing in the way to stop and prevent timely progress by experts and researches from cracking the code to ME/CFS, spread of ME/CFS is exactly what IS happening.  This is a devastation and growing health crisis of global proportions—affecting millions of us world-wide, including young people AND children—stripping their lives and life experiences away from them without ever having lived life and the many wondrous experiences.

It is unconscionable that such a disease has been left to run rampant and trivialized—an atrocity against humankind.  How could this happen?  How could this be allowed to happen ??

I cannot imagine, can you, that anyone would sincerely want such a devastating outcome? 

WHO will be targeted with ME/CFS next—will it be you ? – a near and dear family member – a child—your child—your teen, your spouse ? –  a grandchild; your grandchild ?? The person next to you or someone in their family ?? There are NO boundaries for this serious disease of ME/CFS—there is NOwhere to run from/to with this disease of ME/CFS and it IS spreading; that is a fact.

For those who think that ME/CFS is a female-only disease—look again—and at the same time recognize that—gender is of no consequence—we are all first and foremost people / humans.  MANY males are stricken by ME/CFS and are speaking up and giving visible faces / voices to ME/CFS on behalf of all of us—ME/CFS is not gender specific.

What Are We Asking For ?    WHAT Are the Needs ??

We need money—LOTS of money—to enable the research for a cure to this complex disease called ME/CFS—in the relatively recent past, millions of dollars designated to ME/CFS were ‘quietly shuffled elsewhere’.    Isn’t this a fraudulent act??    It IS INjustice!

We want timely scientific answers to this horrid debilitating biological disease called ME/CFS; and we are calling for cancellation of the IOM Contract and for immediate adoption of the CCC—in support the 50 global ME/CFS Experts and Researchers in their open letter dated October 25, 2013 to the Honorable Kathleen Sebelius, U.S. Secretary of Health and Human Services, as well as the open letter dated November 9, 2013     from the 171 ME/CFS Advocates world-wide.

A change in attitude and outdated mindset is called for to reflect the current scientific biological knowledge of ME/CFS.  It is time for the current significant research progress to be celebrated; along with much appreciation given to the doctors, experts and researchers giving us hope, dedicated to finding the biological scientific answers to ME/CFS—dedicated to caring for the health of their patients—millions of us worldwide!

Let us get serious about cracking the code and solving this mystery of the debilitating complex chronic disease named ME/CFS in a timely manner.  Time is running short for some of us with ME/CFS—who will it strike next?  Will it be you or your family ??

In Conclusion

With all sincerity and a personal and collective thank you to the CFSAC and all attendees at the CFSAC December 2013 meetings for your most important consideration in listening to our voices as we speak up on behalf of pw ME/CFS – the people, the patients, the community—including the young and the very young—we are the voices for them AND the coming generations.

Please listen. Please support us. Please help us.  Let’s STOP ME/CFS with a cure! Thank you!

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Jennifer Spotila, CFSAC Telephone Comment, December 2013

Posted on December 11, 2013 by Jennie Spotila

This is what I told CFSAC via telephone today. It took three phone calls for them to connect me to the meeting.

My name is Jennifer Spotila. I submitted written comments for the record, and I’ve posted those to occupycfs.com.

Unfortunately, I have to say that the management and execution of this meeting has been dismal from start to finish. Your decision to hold this meeting today, everything that preceded that decision, and the technical difficulties we’ve experienced today have all undermined the public trust and the fundamental ability of this Committee to function. You have demonstrated a lack of respect for ME/CFS patients and for the importance of the Committee’s substantive work. This is a serious failure to serve the public interest.

Many advocates, including myself, have dedicated hours to working to improve CFSAC, to supporting CFSAC, and trying to improve the impact of its work on patients. This is personally disappointing to us. I gladly cede the remainder of my time to my fellow advocates.

 

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