Guest Post: Wind Up Clock

Posted on February 24, 2014 by Jennie Spotila

The final post in this stretch of guest authors comes from Claudia Goodell. Claudia is among the most proactive ME/CFS patients I know, trying to make a new life for herself with this disease while also participating in advocacy.

wind-up-peopleI am one out of 1 million Americans waiting for decades in a medical “no man’s land” for solutions to a debilitating disease with no known cause, NO approved treatment and none in the pipeline. We have no designated specialists, and no cure in sight. We feel abandoned by our government who funds research on our disease at a rate less than that of male pattern baldness, we feel failed by the researchers and drug companies who can’t seem to make progress fast enough, and we feel ostracized by the medical profession who throws us around like hot potatoes hoping someone else will handle us. If we are fortunate we have a support system and receive disability, but many struggle alone with no finances and no one to help them, some of whom are completely bedbound. We are so determined to return to the healthy active lives we once knew that some of us will try whatever we can to get well.

When I was in graduate school my professor of Auditory Neuroscience and Psychoacoustics lectured us about sound pressure. In teaching us the mathematical equation for sound traveling through the acoustic system, he made sure we understood that if one looked at only the first part of the equation it would appear that an acoustic signal actually gained energy as it passed through the middle ear. However, this increase only compensates for the loss of energy that eventually occurs when the sound enters the fluid filled inner ear. The net amount is actually a slight loss in energy, and if you see the entire equation this is clear. In order to make this point he taught us, “There ain’t no such thing as a free lunch” (TANSTAAFL), meaning that even if something seems like it is free, there is always a cost, no matter how indirect or hidden.

While I didn’t retain much of my hearing science knowledge, I remembered TANSTAAFL, and ME/CFS reminds me of this every single day. It’s as though I am an old fashioned wind up clock ticking along and then running down. As I run out of energy my tick tock sound gets slower and slower.  I sit on the table for various intervals, until someone randomly walks by, sees me and decides to rewind my mechanism. I may be mid-way between fully wound and fully spent; sometimes they rewind me all the way, and other times just a few rotations. I never know how much energy I really have. I just keep tick-tock-ing at whatever level I am capable given the amount of energy at any one time.

I worry. I worry that if I stop ticking I’ll suffer a slow, progression of this awful disease that forces me to stop moving.  It’s not because I want to stop moving, or because I’d rather sit around than be active. Nothing could be farther from true. But every time I feel well enough to move, and I get out there and do the things I love, at a much reduced level than before the disease I am left feeling a relapse of symptoms for days, weeks or months. This is not motivational, but fortunately I was an athlete before becoming sick, and I am a determined person.

I do all the good things I can to stay in control of my symptoms as best I can. I avoid foods and drinks that my body doesn’t tolerate, and I take only the few medicines and supplements I really need. I insure ample good quality sleep, drink plenty of water, get regular massage, meditate, walk, do yoga, advocate, and I paint. Although this practice gets me close to maintaining some sort of balance between staying somewhat active and being too sick to move, unfortunately none of this is enough to create what could even loosely resemble a full life. I am unable to work, unable to travel without relapsing, unable to participate in sports at a level I would like, and socializing is minimized. So, to quote a famous movie, “I’m not dead yet”, but I’m not really living either. I’m occupying no man’s land with the rest of my fellow patients, and none of us wants to be here.

 

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Guest Post: Frustration

Posted on February 17, 2014 by Jennie Spotila

I continue to struggle with the crash from hell, but Denise Lopez-Majano has graciously provided a guest post. Her thoughts on ME-frustration are right on target for me this week! As a caregiver for her two adult sons, Denise is intimately acquainted with the frustration we feel.

Frustration-253x162Anything to do with this illness is fraught with frustration. A few examples:

Getting a diagnosis often takes years during which time patients and their caregivers are frustrated at every turn.

Getting to see a specialist is also a lengthy and frustrating process for most patients, often involving lots of travel and other expenses in addition to medical expenses.

Processing insurance (if one is lucky enough to have it) is frustrating, time consuming, and hugely cognitively taxing (even for healthy people).

Then there is the frustration of trying one treatment modality after another to try to regain some function.

The unpredictability of the illness is a constant frustration as one tries to learn what is a symptom of the illness and what needs to be addressed by another medical professional (if we can find one who believes in us).

Trying to avoid the exertion that brings on a crash is an exercise (pun intended) in frustration as crashes can be brought on by exertion beyond our limits, by additional illness (example, a cold on top of everything else), and sometimes for no apparent reason because we can be as diligent as possible about staying within the boundaries dictated by ME, and yet sometimes a crash comes on us nonetheless.

The frustration and desolation of losing connections/contact with others as our lives become more and more circumscribed by limitations imposed by illness.

There is frustration as we try to adjust to the decreases in activity levels ME imposes on us.

The frustrations of dealing with the daily stigma/disbelief we encounter from those who don’t understand –  whether it be implying we don’t try hard enough, or “I must have that, I’m tired also”, and on and on.

As limiting as baseline is for most of us, when patients are below baseline, the level of frustration increases with heaping doses of fear piled on top as well and it is a very unwelcome combination.

There is the (often unspoken) fear that this crashed level may become the new baseline and the fear of all the the ensuing adjustments that would need to be made and the fear of the additional losses, increased isolation, additional disbelief, etc…..

Additional frustration gets added to the mix because there is so little we can do to alleviate a crash. It makes us feel even more powerless in our dealings with this beastly illness. For me it is particularly frustrating not to be able to help loved ones/friends get back to baseline.

Frustration and feeling powerless often stops us in our tracks. How do we get going again? How do we deal with the frustration and powerlessness?

I have noticed that when I am feeling particularly frustrated/powerless I often listen to intense music. The music seems to encourage me to validate the pent-up feelings of loss, grief, frustration and powerlessness and I can then turn back to advocacy/caregiving with a bit more determination. While for many, listening to intense music – especially during a crash – would not work, it seems to help me.

What have you tried?

What has worked for you?

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Guest Post: Homeless

Posted on February 10, 2014 by Jennie Spotila
Credit: Jacquelyn Martin

Credit: Jacquelyn Martin

I continue to struggle with the crash from hell, but Joe Landson has graciously stepped up to provide a guest post. His chance encounter on the streets of Washington, DC gave him a powerful insight into our own advocacy situation.

One Sunday in early January, I mustered the energy to take my mother to the National Gallery of Art in Washington, DC, just a few blocks from the Capitol Dome. We walked past a steam grate with the usual collection of homeless men gathering warmth from it. However, one man was different, and stood out. First, he was white. Second, he was very young. Third and most oddly, he made direct eye contact with me, following my movement as I walked past holding an umbrella over my mother. The moment stuck with me, but what could I do? My first duty was to my mom.

The next morning I saw this article about him. For those of you who don’t have time to read the article, an Associated Press journalist photographed the very same man for a story about the cold snap here in the mid-Atlantic. While scanning the news, a friend of friend recognized the young man’s published photo, and alerted his parents. They in turn brought him home to upstate New York. He had disappeared from their house on New Year’s Day.

Yes, it is the same man as the one I saw. I recognized him instantly in the article photo, and the Federal Trade Commission building is directly across from the National Gallery of Art, where my mother and I went.

At first, I couldn’t help but wonder at how unlikely and lucky this rescue had been. Then I wondered if his rescue would ‘take’, if whatever compelled him to leave would be resolved, or if he would be back out on the street again in a month or three. And then after that, I wondered if he was us.

We with ME/CFS are homeless patients with an orphan illness. No medical specialty has claimed us. We have no medical authority to trust. To casual observers, we are obviously lazy whiners; to those paying attention, we are an unsolved mystery. In any case, we are waiting on a steam grate for some random investigator to publicize an image of us that will produce a shock of recognition for the awful disease we know we have.

We are waiting for our image to be recognized, because it’s hard to believe that anything we say makes any difference. I certainly get that feeling from the many meetings I have attended. Certainly nothing the homeless man said in a news interview could have mattered to the journalist, even if she wanted to help him. He was, quite literally, background for a story. But publishing his photograph possibly helped more than anything else she could have done.

It has been said before: 80 percent of success is showing up. So I’m beginning to wonder if all we can do is show up and wait – in other words, the two things we are least able to do. We desperately need help now if we are to recover anything resembling lives for ourselves. We only survive the endless waiting by NOT showing up – by skipping out on work, family duties and events, and virtually every aspect of public life.

It is very, very hard for most of us to show up and be seen: By doctors who don’t get it. By disability adjudicators who don’t believe us. By government officials with no sympathy. We meet cynical contempt everywhere, over and over again. Yet I’m becoming convinced that being seen, like formerly homeless Mr. Simmons was seen online, is the only hope for us, the only effective thing we can do. We can speak all we wish, to demand attention and more research, and we have at least partly succeeded here. However our words are powerless to influence the medical ‘facts’, as the licensed fact-makers see them. To the doctors and researchers, we can only mutely present ourselves for observation.

 

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The Finger

Posted on February 3, 2014 by Jennie Spotila

figur hat akku leerLast week, my body gave me the finger. I can’t even say I didn’t deserve it. After more than 19 years, I still don’t always listen to my body and this makes her very, very angry with me.

I’ve previously talked about how rotten 2013 was for me personal life-wise. And about how advocacy work around the IOM contract has been overwhelming. But I am a stubborn woman, especially when it comes to learning from my mistakes. Already depleted, I threw myself into the research and analysis of the IOM Panel in December. I spent the month of January preparing my presentation to the IOM (written and video available). And there was that little thing called “the holidays” smack dab in the middle of it.

I thought I had everything under control. I pared January down to the essentials – only what absolutely positively HAD to be done in order to prevent physical, financial or emotional harm to me and my family. And coming to the end of the month, I thought I nailed it. My presentation was ready and basically memorized. I submitted my written version with references on time. And the absolutely-positively-must-be-done-in-January list was mostly accomplished. I was determined to attend the meeting and give my presentation in person.

Then I got sick(er). Not just a crash. I mean SICK. There’s some difference of opinion in the house about whether it was a bad cold on top of a crash (husband’s theory) or influenza partially mitigated by my flu shot (my theory), but it doesn’t really matter. I was bedridden with a fever, etc etc for five days, and the IOM meeting was on day three.

So despite all my preparation and organization and determination, I could not give the presentation in person. My husband later said that he thought the trip to DC would have ended in an ambulance ride. He says I haven’t been this sick since my two day CPET in April 2012.

I gave my IOM presentation from bed, feverish and not really sure if I was saying it right. It seems like I got my point across. And I’ve certainly dealt with the disappointment of missing out on something I really wanted to do before. Endlessly. For more than 19 years. The reality of this disease kept many people from attending the meeting (or even watching it). The reality of this disease exacted a high price from the patients who were able to attend.

But this felt a bit different to me. I felt like I was being punished by my body. That she reached the breaking point with the I’ll-just-push-a-little-harder routine, the endless repetition of I’ll-just-keep-going-until-the-end-of-the-month /project/year/controversy/crisis. And of course, my body had reached the breaking point and I was the one responsible.

Every single patient-advocate I know does this. I started a list, and realized I couldn’t even name you all here because every one of us does this. Sometimes, a patient has to drop out of advocacy for awhile (or forever) to try and recover. Most of us keep going until we just can’t. As soon as we can get back up, we are at it again. ME/CFS voices must be heard, and that means that those who are able and willing must speak. And pay the price for as long as we can.

I know there’s a balance point, a magical formula for parsing out work and rest. It’s just that I don’t like where that balance point is. There is too much advocacy work to be done, and nowhere near enough of us to do it. So many of you are putting yourselves at risk to make things better for all ME/CFS patients. I have to help.

My body gave me the finger. I deserved it. It remains to be seen if I actually learn from it this time around.

 

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Accurate and Precise

Posted on January 27, 2014 by Jennie Spotila

This is the text version of my presentation to the Institute of Medicine Panel today. I delivered my comments remotely, because a fever has kept me bedridden for three days. I tried to speak as naturally and extemporaneously as possible, so there are some differences between the spoken and written versions. I also submitted a much longer version with more details and references to the Public Access Folder. Update January 31, 2014: Video of my talk has been posted.

My name is Jennifer Spotila and I have been disabled by ME/CFS for more than nineteen years. I’ve been involved in advocacy for most of that time, including past service on the CFIDS Association Board, and appointment to the FDA’s Patient Representative Program. I write about politics and other ME/CFS issues at occupycfs.com. My perspective on this IOM study is informed by all of that experience, and I believe the one thing you must keep in mind throughout this study is to be as accurate and precise as you can in order to create sensitive and specific diagnostic criteria.

The Challenge

You are facing an enormous challenge, the result of decades of inaccuracy and imprecision in the definition and diagnosis of our disease.

Multiple names and definitions have been used in the last 30 years, and you should go back as far as the 1950’s to examine the descriptions and definitions of ME. Each definition carries with it a rationale, an associated description of the disease, and a set of limitations. Prevalence rates vary because each definition draws a different circle around – or within – a patient population.

Another challenge is that there are no gold standard biomarkers for the heterogeneous Fukuda population. Despite that, we are very close to establishing one or more diagnostic marker, and a number of you have been responsible for that important research. But the breadth and weaknesses of the case definitions have been a huge obstacle to achieving this.

Finally, as you no doubt realize already, there are competing schools of thought on case definition. Does the mixed bag of definitions describe one disease or more than one disease? How do we identify a more homogenous cohort? What should we call it? Who is competent to diagnose it? We do not agree on the answers to those questions because there are no easy answers.

Potential Pitfalls

As in any controversial subject, there are potential pitfalls that could complicate your work.

First and foremost is the fatigue paradigm. Severe fatigue lasting longer than six months is an extremely common symptom experienced by 4-5% of the general population. One study of newly diagnosed MS patients found that nearly 30% had been diagnosed with severe fatigue or CFS in the three years prior to the MS diagnosis. Because it is based on fatigue, the Fukuda definition has been used as a wastebasket for people with unexplained fatigue, consigning them to medical purgatory when they may have more treatable conditions.

It might help to draw a comparison to chronic pain. While pain conditions are researched across diseases to identify common mechanisms and treatments, we do not define and diagnose them that way. We do not diagnose fibromyalgia, vulvodynia, and migraines as one disease that is subtyped based on where the pain is located in the body because chronic pain is simply too common a symptom. I believe the same is true for the fatigue paradigm. Severe fatigue is simply too common a problem to form the basis of an accurate and precise case definition, regardless of how you try to slice it into subtypes.

Second, as Charmian pointed out, it is imperative to recognize which definitions and exclusionary conditions were used in each research study. If you do not take this into account, you will not be able to sort through the evidence with any resulting clarity.

Third, I believe it would be a mistake to lose sight of the impacts your report will have in the real world. As Lori and Pat have said, you will have an impact on research and clinical trials. You will have an impact on policy. You will have an impact on clinical care. The stakes are very high, but there is a solution.

Accurate and Precise

I believe it is possible to create diagnostic criteria that is both sensitive and specific for ME/CFS. To do so, you will need to be as accurate and precise as possible.

Start by setting aside the fatigue umbrella, because severe chronic fatigue is common to many diseases, and should not be used as the foundation of a precise case definition. Instead, focus on the core symptoms of disease. Across multiple studies and surveys, post-exertional malaise – not fatigue – has emerged as the key and most disabling feature of this disease. PEM is an exacerbation of multiple symptoms after mental or physical activity, and can be measured through both self-report instruments and objective biological tests. It is also notable for its use in distinguishing between people with ME/CFS and those with major depressive disorder and other illnesses with a fatigue component. Another core symptom identified in the research is cognitive impairment, particularly memory and concentration problems. Unrefreshing sleep and autonomic symptoms also rise to the top. There are many other symptoms as well, but your diagnostic criteria will be more meaningful if you focus on the core features.

Another approach that will help you succeed is to use frequency and severity thresholds, in addition to a list of symptoms, to identify a more precisely defined patient population. In one study, 34% of healthy controls reported at least 4 out of 8 Fukuda secondary symptoms. When higher cutoff thresholds for frequency and severity measures were used, that number dropped to 5%. If you combine a core symptom set with thresholds for frequency and severity of those symptoms, I believe you will be able to establish accurate diagnostic criteria that have high sensitivity and specificity.

Precision is the most important tool at your disposal, and yet it will not remove all ambiguity and uncertainty because there is so much we do not know about this disease. Three hundred years ago, cancer could only be diagnosed when it advanced to externally palpable tumors. The definition of cancer has evolved from the most severe and easily detected form of the disease to the sophisticated detection and subtyping methods of today.

Your case definition is part of an iterative process, like all case definitions. Most criteria broaden over time, such as the 2011 revision of the diagnostic criteria for Alzheimer’s Disease.  But that only happens after diagnostic criteria have been tested and validated on the more severe forms of disease. Precision based on what we know, is the first step.

Conclusion

In summary, you face the enormous challenge of creating diagnostic criteria for a disease with conflicting case definitions, no gold standard biomarkers, and competing views about how to define the problem. You must avoid multiple pitfalls, including the high prevalence of the symptom of chronic fatigue in the general population and the effects of those competing case definitions on research results, and never lose sight of the very high stakes we face. But there is a way for you to overcome all of these challenges, and that is by being accurate and precise. If you set aside the fatigue umbrella and focus on the core symptoms of this disease, if you establish frequency and severity threshold requirements, and if you recognize that your diagnostic criteria will be part of an iterative process of refinement, then I believe you can create diagnostic criteria that will advance clinical care and research, instead of putting us further behind: a definition that is sensitive and specific for ME/CFS.

I have submitted more details in writing, including references, for your review. Many of my fellow advocates have done the same, and I hope you will review that material with the same attention you have given us this afternoon. If you have any questions about what I’ve presented or if I can assist you further, here is my email address: jspotila AT yahoo DOT com. Patients are an essential resource for your task, and I hope you will involve us to the fullest extent. Thank you for the opportunity to speak to you today.

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At the Microphone

Posted on January 20, 2014 by Jennie Spotila

Next Monday, the IOM Panel creating new diagnostic criteria for ME/CFS will hold a public meeting. This may or may not be the only public meeting for the study, and it will be webcast. As you can see, I am one of seven advocates on the agenda at the invitation of the IOM. Contrary to what some people may think, I believe it would have been wrong to decline the invitation.

Image credits: suzannegaudetbenefit

Image credits: suzannegaudetbenefit

I don’t know how the IOM selected the people and organizations to speak at the meeting. IOM staff would not release a list of the people invited, just the final list of seven who accepted. They may have invited others, although I haven’t heard anything about it through the grapevine.

There’s been some grumbling about it, including whether we were selected because of the positions we’ve taken on the IOM contract or because of what IOM thought we would say. Honestly, I have no idea. I received the invitation and immediately accepted. Some might think this makes me a sell-out, or that some or all of us should have declined.

In my personal opinion, that’s bogus.

I see this through the lens of my legal training. When the Supreme Court invites you to present oral argument, you don’t refuse to show up because you don’t like Justice So-and-So’s politics. Your role is to show up and present the best argument you can, whether or not you believe that you will win.

Like it or not, the IOM study is happening. None of us can predict the future: maybe the contract will be rescinded, or maybe not. But as of right now, the IOM is in the process of creating new diagnostic criteria for ME/CFS. Why on earth should I refuse an invitation to tell them what I think about that?

A fellow advocate commented to me last week that refusing this opportunity to provide input is a bit like refusing to vote and then complaining about the government. I don’t know if IOM will get it right; I can’t even assess the odds of that happening. But I do know that if we refuse to speak or if we withhold our input, then we place a very heavy burden on the ME/CFS experts on the panel to make all these arguments for us. If we refuse to speak out, then we make it easier for the panel to come up with the wrong answer. I have no delusions about whether anything we say will alter the entire course of the study. But I do know that if we say nothing at all, we are playing right into the hands of those who think we’re not “qualified” enough to be worth listening to.

I know there are people who would prefer not to deal with ME/CFS patients. There are people who think patients don’t know enough to speak on scientific or medical questions. I think it likely that there are people who would prefer for us not to show up at all. Fortunately, I have not encountered that attitude among the IOM staff members. Whether any of the panelists feel that way is anybody’s guess. But I’ve always been the kind of person who speaks her mind, even when some people wish I wouldn’t.

There are advocates missing from the list of speakers who I wish had received invitations. Fortunately, at least a few of them have three-minute slots in the last session of the day. The IOM panel needs to hear directly from these advocates, and I’m grateful that they are willing to speak – especially because of the physical and financial costs of attending the meeting in person. For me personally, I am putting my health at risk to attend in person, but I believe there is enough on the line to make it worth the sacrifice.

Anyone can submit written comments to the IOM panel, and I hope that many people will. Instructions are below. Before you dismiss this opportunity, consider this: do you believe anyone will speak for us if we refuse to speak for ourselves?

If you would like to submit written comments for the first meeting, please use the email (mecfsopensession@nas.edu). Please focus your comments on the following question: “What is the most important aspect or information that this committee should consider throughout the course of the study?” Written comments received by January 22, 2014 will be distributed to the committee before the meeting on January 27. After January 27, written comments should be sent to the project email address (mecfs@nas.edu). All comments will be considered by the committee, but they may be distributed after the meeting is adjourned.

 

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More on P2P

Posted on January 13, 2014 by Jennie Spotila

Robert Miller posted a statement on Facebook last night revealing that he was one of the members of the P2P Working Group that met at NIH last week. I’ve posted his full comment below, with his permission.

Bob is very positive about the meeting and P2P process. I’ve spoken with several people who attended this meeting, and I have heard mixed reactions. Some are positive, some quite negative. The members of the Working Group are all, as Bob says, some of our best experts. Bob says that NIH listened to their input, and that the Working Group “drove the agenda” for the P2P Workshop. Again, I have not heard the same optimistic assessment from everyone who attended the meeting.

As I said before, there are two fundamental problems with the P2P process:

  1. The P2P panel cannot – by design – include anyone who has ever published on ME/CFS or taken any position on it. The Workshop could be exactly as Bob and the other Working Group members designed, but non-experts will do the evidence review and non-experts will comprise the entire Panel. That Panel will write the final recommendations, not the Working Group or meeting presenters.
  2. There is no transparency. I am very glad Bob came forward to acknowledge his participation in the Working Group. But the questions they finalized at the meeting have not been made public. The roster of the Working Group has not been made public (although word is leaking out). My understanding from two people who attended the meeting was that the discussions at the meeting were confidential. While Bob and the Working Group nominated potential panelists, the actual selection process will be done in secrecy. We will have no input, and no idea who those panelists are until the meeting is about to happen.

This is not acceptable to me.

We are constantly admonished not to question the motives of the people involved in these efforts. I do not question anyone’s motives, nor have I seen evidence of a conspiracy. I agree with Bob’s view that we should engage in these issues in a positive and professional way. My advocacy “career” is based on those values.

But a P2P Panel that will not include any ME/CFS experts? A Panel that will be selected behind closed doors? An evidence review conducted by non-experts? And the outcome of the process is a series of recommendations on diagnosis, treatment and research? No, no, no, and no.

The ME/CFS advocacy community would never have accepted an IOM committee that had no ME/CFS experts on it. We already know that the P2P panel will involve no ME/CFS experts. I do not accept this, and neither should you.

People have asked me what we can do about it. I am actively pursuing several options, and I will keep you posted.

Here is Bob’s statement from Facebook last night:

A brief update for everyone: last week I was invited as a patient representative to the NIH Working Group meeting for the NIH Pathways to Prevention Workshop on #MECFS (happening in the future). This is what was described as an Evidence-based Methodology Workshop at last Spring’s CFSAC meeting. I was asked at the last minute because the original patient advocate could not attend. The Working Group was charged with preparing questions for a thorough evidence-based literature review to identify gaps in ME/CFS scientific research, and we recommended expert speakers and independent panel members for the workshop itself. You can find details of the P2P program below. It is an independent scientific review, and the same process has been used before with another illness.

I want everyone to know my perspective. The Working Group was composed of some of our best experts, and I developed real respect for the person who will Chair the independent panel. Our experts and I had real input into the agenda and questions. The Working Group drove the agenda, and we will participate in the Workshop. I believe the prep work for the Workshop is being done with strong representation from our illness, laying the foundation for a good outcome.

I have been pretty ill in recent months, so I have been stingy with my energy. It has been difficult to post a lot about what is happening in our illness. With this NIH Workshop in mind, and the other governmental initiatives occurring in ME/CFS, I want to encourage patients to engage positively in federal work on our illness. We have had 25 years of inaction by the federal health agencies, and that hasn’t been good for us. All of us have asked for a serious commitment to ME/CFS by the federal government. That is what President Obama promised my wife. These initiatives – the FDA Drug Development Workshop, NIH Pathways to Prevention Workshop, Institute of Medicine Diagnostic Criteria Panel, the CDC’s 5 year Clinical Assessment Study – are all steps toward a stronger federal response. All of these initiatives are not an accident – they are the result of years of work by many of our patients and advocates, to change the federal approach for the better. Patients educated the FDA last spring in a way that has never happened before, and we have the same opportunity at the IOM meeting coming up. The IOM has strong representation on the ME/CFS Committee because patients engaged in it. We need to mix our expert clinicians & scientists with new experts in relevant fields of biomedical research to change our health. I welcome all of these initiatives and know that we will have to do hard work on the details. We won’t agree with everything in these processes or outcomes, but we need government support and action to improve diagnosis, treatment and understanding of ME/CFS. I continue to believe we need to Unite to make the most of new government attention and that 2014 will be a turning point in so many ways. Happy New Year to every one who suffers from ME/CFS. I promise we will move forward together in 2014!

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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.

 

Posted in Advocacy, Research | Tagged , , , , , , , , , | 51 Comments

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.

 

Posted in Commentary, Occupying | Tagged , , , , , , , | 30 Comments

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.

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