August 20th, 2014 13 comments

renewalWill the CFS Advisory Committee be back this fall? Not many people seem to be paying attention to the fact that it could potentially disappear.

The CFSAC is a chartered federal advisory committee, and by law it must be renewed every two years. The current charter will expire on September 5, 2014. There has not been a single peep about whether renewal is pending.

In the past, renewal has sometimes been pro forma and sometimes has required a little push from advocates. Public input has been sought on revisions to the charter as well. In 2012, you may recall, the addition of the non-voting liaison members was proposed and the public was able to provide comment on that change to the charter. This year? Nothing.

That does not automatically mean that the charter will not be renewed. After all, four new members were just appointed this summer, along with the renewal of two current members. The formation of new working groups after the June 2014 meeting also suggests that a new charter is forthcoming.

Would it be a bad thing for CFSAC to disappear? Many advocates would say no. They believe that CFSAC is an exercise in futility that drains our focus and resources away from more productive advocacy efforts. I certainly understand and share this frustration, and I’ve been a vocal critic of some aspects of the committee’s operation and recommendations.

But I think it would be a great loss for CFSAC to be dissolved. Right now, the agency representatives must give reports and answer questions. Think of all the things we have learned about only because of those reports. For example, we learned that the second phase of CDC’s multisite study will not include two-day maximal exercise testing, and CDC is relying on the advice of some ME/CFS experts in doing so. We learned about the P2P meeting more than a year before the final approval was given and the meeting officially announced.

And don’t forget that information flows the other way, as well. Through our public comment, advocates have not only conveyed the seriousness of the disease and need for urgency in the federal response. We have managed to put many issues on the public record, including sharp criticism of the CDC multisite study, the P2P meeting, and more. Do not underestimate the importance of that public record. HHS may continue to ignore what we say, but they can’t say they didn’t know and we can use that public record in other political venues.

I’ve heard it said that HHS would love to have an excuse to make CFSAC go away. For that reason alone, I hope it is renewed. I do not see a down side to requiring the agencies to report on their actions (or lack thereof), information that it would be very very difficult for us to get any other way. So let’s hope the renewal is pro forma, and that I can update this post in two weeks with a new charter.

Update August 22, 2014: The Solve ME/CFS Initiative announced via their website yesterday that they had written to Secretary Burwell in support of CFSAC renewal on August 1st. To date, they have not received a response. Read the full letter here.

Update August 24, 2014: Billie Moore, non-voting liaison for the NJCFSA, says in the comments below that there will be a fall meeting of CFSAC, and it will be via webinar. This was confirmed to me by another source, as well.


Limited Capacity

August 13th, 2014 22 comments

Custom-Maximum-Capacity-Sign-S-3515Life with ME/CFS is all about limits. Physical. Mental. Emotional. It’s like living in a glass box that remains far too small, no matter how much you practice acceptance or positive thinking. And the torture of it is that since the walls are glass, you can see everything you used to be able to do/handle/tolerate.

Physical limits are the easiest to see and delineate. How many steps I can take, at once and in a day. How long I can stand. How long I can sit upright. How many times a week I can cook. How many times I can leave the house. How many doctor appointments I can handle. How much I can carry. How high my heart rate should go. How much sleep I need.

Mental limits are harder to see, but I can still describe the edges. How much noise I can tolerate. How many conversations I can follow. How long I can use the computer. How much I can read. How much I can write. How long I can think critically or strategically. How long I can listen to music or watch tv. How long I can talk on the phone. How often I can blog.

Then there are the intangible emotional limits. Like how much pain I can tolerate. How much Facebook advocacy drama I can tolerate. How much bad news I can take.

What is striking about these limits is that there is an overall fixed capacity. If I’m more physically active, I can’t read or write as much. If I’m under a lot of stress, my physical capacity disappears. And every. single. thing. adds up.

Take Twitter. I love Twitter for entertainment and news. I’ve met wonderful people through Twitter. Twitter is better than Facebook (at least for me). I’ve always been limited in the number of people I can follow, or how often I can check it in a day. But now I’m running up against a new Twitter limit: how much I can handle emotionally.

Every time I check Twitter, I am hit with bad news. Gaza. Michael Brown. Robin Williams. And then there is the fact that people seem meaner these days. Prejudice. Criticism. Waves of people Tweeting about racism or misogyny that they’ve experienced. I already don’t watch tv news because it made me mad. Even The Daily Show was upsetting me. If 9/11 happened now, I doubt I could handle the news coverage.

Maybe it’s because I’ve had so much personal bad news in the last two years. Or maybe it’s because my advocacy efforts (and accompanying stress and frustration) have increased. Whatever the reason, I’ve got almost no capacity left for emotional load. Most nights, I space out to a baseball game, awaiting my next scheduled pain med, and there is NOTHING left over – no capacity of any kind. And that’s not good. It means I’m less available to my friends and family. It means I’m out of balance.

I can tell when I’ve exceeded my emotional capacity. I lose my patience. Small frustrations make me very angry. My initial reaction to news, questions or problems tends to be knee-jerk anger or resentment. I curse more (and more creatively), to be honest.

But if I have learned anything during my years with ME/CFS, it is that the boundaries of my limits are out of my control. There is a maximum capacity, and if I exceed it then I pay the price in pain and even less capacity. The only thing I have some control over is what fits in the glass box. That box is only so big, and I can only cram so much in. It comes down to choices – what goes in, and what gets left behind.


You’ve probably already read this, but it’s worth repeating: The Spoon Theory by Christine Miserandino.

Update August 14, 2014: Tracey Tempel Smith wrote this beautiful piece after reading my blog post. She has graciously given me permission to reprint it here. I hope you find it as powerful as I did.

Glass Box: A Life Confined by M.E.

This is inspired by Jennifer Spotila’s post that describes trying to balance life/health while dealing with the restrictions/confinement caused by Myalgic Encephalomyelitis. She sees it as living in a glass box, a life limited. I agree, and this is what it feels to me right now:

I am having a chance to slowly stretch my box. It is like a process knowing if you put too much inside, cracks start to form. But if you are allowed to lessen the amount in hopes that tiny bits of excess energy builds over months; the warmth starts to soften the glass, to stretch a little. Like a glass blower.

When excess energy runs out, the heat dissipates, glass may cool too quickly, hardens, and cracks form. Then you have to stop, if not the PENE shatters your box and it reforms smaller… Never knowing how small that box will shrink. It is a very subtle process because we can’t always hear the beginning cracks forming, and stop in time before destruction happens.

Sometimes the cracks start slow; sometimes it’s a sudden explosion where you can loose pieces of glass forever. But the glass will always be there in varying degrees of thickness and size. And during this time, in this glass box, there are times where objects outside are thrown at it, and you can’t move the box out of the way. A sitting target, stuck in the shattered pieces, hoping that healing will happen.

To those outside, glass will seem invisible from some perspectives, but just change a viewpoint and the edges of the box appear. Get close and reach out, and touch it, then understand by imagining how it feels to the one surrounded by it.

Some remain so close, the glass is invisible but if they don’t attempt to reach out they won’t feel the glass. They remain in complete disbelief the glass even exists.


La La La, I Can’t Hear You

August 4th, 2014 19 comments

On May 28th, Mary Dimmock and I sent NIH Director Dr. Francis Collins a 38 page packet outlining our concerns that the P2P Workshop will not advance the ME/CFS research field, and may even set it back. We finally got a reply, but it is by no means a response to anything we said.

The reply came from Dr. James Anderson, Director of the Division of Program Coordination, Planning and Strategic Initiatives. The Office of Disease Prevention, which is running the P2P Workshop, is within that Division. Dr. Anderson acknowledges our letter to Dr. Collins:

First, let me applaud your commitment to advocating for patients and their families struggling with this condition. I recognize your depth of knowledge in this area, and I appreciate your outreach to NIH allowing us to provide our perspective on the ME/CFS research and the P2P.

Dr. Anderson then devotes the rest of the letter to an explanation of the P2P Workshop process and expected outcomes. Needless to say, this is information with which Mary and I are already quite familiar, as would be obvious to anyone who actually read our letter to Dr. Collins.

vintagelalalaThat’s it. A two page letter (which you can see here) explaining the P2P process to us, again. No comment on the fact that the review and the Workshop failed to ask if the ME/CFS definitions actually encompass a group of disparate conditions. No comment on their failure to meaningfully engage stakeholders. No comment on the failure to “synergize” with IOM. No comment on ANY of the issues we raised in our letter to Dr. Collins. None.

Is it because Mary and I are not affiliated with a non-profit? Is it because we don’t have PhD after our names? Is it because we didn’t create enough noise, despite the fact that more than 100 of you wrote to Dr. Collins yourselves? Is it because NIH, as an institution, is not interested in the concerns of patients when it comes to science and policy matters? Whatever the reason, Dr. Anderson’s letter is a wordy dismissal. Our concerns – calmly stated and supported by evidence – do not merit a mention, let alone a reply.

Dr. Anderson and NIH may want us to just go away, but we won’t. We’ve already written to the Working Group about the failure to adequately address the case definition issues in the agenda. Now we’re taking our concerns to the Hill.

We have written to our Congressional leadership, asking for their help in requesting that NIH respond to the concerns raised in our letter. NIH may not see itself as accountable to ME/CFS patients or researchers, but it is most certainly accountable to Congress. And Congress doesn’t like being ignored or brushed off any more than we do.

If you don’t like being ignored by NIH, if you think that NIH should address serious concerns in a forthright manner, then write to your own Congressional leadership. Model a letter from ours (below), or write your own. The bottom line is that if we stop, if we give up, then they win. This is what they are counting on: that we are too sick and too small to make much of a fuss.

We deserve better, and we’ll keep fighting until we get it.


We are writing to provide you an update on our letter to Dr. Francis Collins regarding the Office of Disease Prevention Workshop on ME/CFS (“P2P Workshop”).

You may recall that we wrote to Dr. Collins on May 28, 2014 to express our concern that the P2P Workshop will not produce scientifically sound recommendations to move the ME/CFS field forward. Our letter included extensive documentation in support of those concerns. We have now received a response from Dr. James Anderson, Director of the Division of Program Coordination, Planning and Strategic Initiatives (enclosed).

We regret to say that Dr. Anderson’s reply was completely unresponsive to our concerns.

He does not even acknowledge that we expressed concerns, let alone respond to any of the evidence included with the letter. Dr. Anderson simply reiterates the same information about the P2P Workshop that NIH has already communicated broadly.

Dr. Anderson’s reply is yet another example of NIH’s persistent refusal to meaningfully engage with ME/CFS advocates. The Solve ME/CFS Initiative, a national organization for this disease, wrote to NIH that “there are serious flaws with the sample search strategy” for the systematic evidence review, and that the search “will bias the evidence base to [psychological and exercise treatment] trials . . . and will fail to assess any of the important biomarker research.” More than 100 advocates have written to Dr. Collins to express their own concerns about the P2P Workshop. We are not aware of any substantive response from NIH to anyone who has raised objections to NIH’s approach.

This is not acceptable. It appears that NIH has no intention of reexamining the scientific framing of the P2P Workshop, no intention of meaningfully engaging stakeholders, and no intention of mitigating the significant risk that the P2P Workshop will impede the field of ME/CFS research.

We are committed to advocating for strong science and public policy in service to ME/CFS patients and their families. But for that to happen, we need your help. We would appreciate any assistance you could provide in requesting NIH respond to the specific concerns we raised in our May 28 letter to Dr. Collins. Please do not hesitate to let us know if you have any questions.


IV Saline: Magic Juice

July 28th, 2014 9 comments

magicjuiceBack in March, I started an experiment with IV saline. Four months in, I have learned a lot about how and when the treatment helps me.

IV saline has been used to treat orthostatic intolerance for many years*, and some ME/CFS patients have also found it helpful. ME/CFS patients may have low blood volume, and autonomic nervous system dysfunction is well documented. Those with joint hypermobility may also have more elasticity in their blood vessels. All this adds up to common symptoms in ME/CFS: dizziness, weakness, altered gait, cognitive difficulties, and fatigue.

Saline helped me get over the hump in recovering from my two day CPET, and so I thought it might be worth another try. My doctor and I agreed to try once weekly infusions of 2 liters of saline (1 liter per hour) for four weeks, take a two week break, then another four weeks of treatment. After the first infusion, my husband said I lost my pallor and seemed more energetic. I was able to tolerate the weekly trip out of the house to get the saline without crashing, which suggests that I was getting at least enough benefit to offset the trip.

After each infusion, I felt like I had an energy bump for a couple days. Sometimes, I could feel it during the infusion itself. I described it to someone as feeling like a film was being peeled off my brain, making it possible to think more clearly. But as the weeks went on, the benefit was less apparent to my husband. I seemed to be holding steady, rather than improving. I started to wonder if it was worth it.

Then I attended the Institute of Medicine meeting in May, and crashed afterwards. I struggled to get to my scheduled infusion two days later. But by the time I started the second liter, I started to feel better. The nurse commented to me that my gait was different, I had color in my face, and my voice was different. She actually couldn’t believe how different I looked leaving the center compared to how I had been coming in, and she made a note of it in my chart. And I felt dramatically better, too. Once again, saline seemed to get me over the hump of the crash.

After consultation with my doctor, we decided that I should reserve the saline for crashes or times when I thought I really needed it. He put standing orders in the system so I could simply schedule infusions when I needed them. He also provided me with a letter (as did my CFS specialist) so that I could get saline while traveling. This turned out to be key.

For the first two weeks of July, I was on vacation with my family. It required a long car ride to get to the quiet house where I spent the trip. After arriving, I was weak and crashed. We went to the local emergency room armed with those letters. It is incredible how easy the process was, especially compared to the horror stories I have heard from patients about their ER experiences. I reported that I felt weak and dizzy, and shared the letters. I was whisked back and set up with saline, without much of an examination or even putting on a hospital gown. And as before, the saline helped me get over the hump of the crash. I debated going back for another infusion, but treatment took so long that I didn’t want to lose another day. I decided to tough it out.

I scheduled an infusion for several days after I got home, but after a long ride in terrible summer traffic it was pretty clear I would not be able to wait. My husband took me to our local ER, and once again the letters eased the way. This time, though, the ER insisted on a gown, drew blood for routine labs, etc. On the upside, they were able to slam that saline in at twice the usual rate – a little over an hour for two liters. And once again, there was a noticeable improvement in my gait, speech, thinking, and energy. My doctor agreed that I could still get my scheduled infusion, so I ended up getting two infusions in one week.

It made a huge difference. Yes, I was crashed but it was nowhere near what I went through after the last family vacation. I’ve been pacing myself pretty strictly, but I haven’t been confined to bed. In dealing with crashes, saline is clearly a huge win for me.

So what does this mean long term? I can add saline to my arsenal for dealing with crashes. It’s not a cure, but it definitely reduces the severity of the crashes (at least, so far). I do not want a port and all the risks that come with that, and home infusion does not appear to be an option with my insurance. But to the extent I can predict my crashes after high activity, I can schedule the saline to help get me over the hump. And if I crash suddenly, there is always the ER with the way smoothed by those letters.

Should you try saline? If you have orthostatic intolerance, it might be worth discussing with your doctor. There is no protocol or standard of care with this. How much saline and when is very much trial and error. But if your doctor is willing to experiment a little bit, it might be worth a try. For me, every little bit helps and evening out the hump of a crash makes a big difference in my quality of life.

Saline won’t help me get back to work and it’s not a miracle cure. But it feels like a miracle to walk out of the infusion center feeling two or three times better than when I walked in. That’s why, when I post about an infusion online, I always say: SALINE!! *jazz hands*



Rosen, SG and Cryer, PE. Postural tachycardia syndrome: reversal of sympathetic hyperresponsiveness and clinical improvement during sodium loading. Am J Med. 1982; 72: 847–850

Burklow, TR, Moak, JP, et al., Neurally mediated syncope: autonomic modulation after normal saline infusion. J Amer Coll Cardiol 1999; 33: 2059-66.


P2P: The Question They Will Not Ask

July 21st, 2014 37 comments

by Mary Dimmock and Jennie Spotila

cornerstone-contentThe most important question about ME/CFS – the question that is the cornerstone for every aspect of ME/CFS science – is the question that the P2P Workshop will not ask:

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 the illness or do they encompass the entirety of the population?

Boiled down to its essence, this set of questions is asking whether all the “ME/CFS” definitions represent the same disease or set of related diseases. The failure to ask this question puts the entire effort at risk.

This fundamental question was posed in the 2012 application for the Office of Disease Prevention to hold the P2P meeting (which I obtained through FOIA). It was posed in the 2013 contract between AHRQ and the Oregon Health & Science University for the systematic evidence review (which I obtained through FOIA). It was posed to the P2P Working Group at its January 2014 meeting to refine the questions for the evidence review and Workshop (according to Dr. Susan Maier at the January 2014 Institute of Medicine meeting).

And then the question disappeared.

The systematic evidence review protocol does not include it. Dr. Beth Collins-Sharp said at the June 2014 CFSAC meeting that the Evidence Practice Center is not considering the question because there is “not enough evidence” in the literature to answer the question. However, she said that the P2P Workshop could still consider the question.

But the draft agenda for the Workshop does not include it. Furthermore, every aspect of the P2P Workshop treats “ME/CFS” as a single disease:

  • The P2P description of ME/CFS refers to it as a single disorder or illness throughout the meeting webpage.
  • The P2P website characterizes the names myalgic encephalomyelitis and chronic fatigue syndrome as synonymous.
  • Every section of the Workshop agenda lumps all the populations described by the multiple case definitions together, discussing prevalence, tools, subsets, outcomes, presentation, and diagnosis of this single entity.

A 20 minute presentation on “Case Definition Perspective” is the only lip service paid to this critical issue. This is completely inadequate, if for no other reason than because the presentation is isolated from discussions on the Workshop Key Questions and dependent topics like prevalence and natural history. As a result, it is unlikely to be thoroughly discussed unless one of the Panelists has a particular interest in it.

Why is this problematic? Because both the P2P Workshop and the evidence review are based on the assumption that the full set of “ME/CFS” case definitions describe the same disease. This assumption has been made without proof that it is correct and in the face of data that indicate otherwise, and therein lies the danger of failing to ask the question.

What if the case definitions do not actually describe a single disease? If there are disparate conditions like depression, deconditioning, non-specific chronic fatigue and a neuroimmune disease characterized by PEM encompassed by the full set of “ME/CFS” definitions, then lumping those together as one entity would be unscientific.

The most important part of designing scientific studies is to properly define the study subjects. One would not combine liver cancer and breast cancer patients into a single cohort to investigate cancer pathogenesis. The combination of those two groups would confound the results; such a study would be meaningful only if the two groups were separately defined and then compared to one another to identify similarities or differences. The same is true of the P2P evidence review of diagnostics and treatments: assuming that all “ME/CFS” definitions capture the same disease (or even a set of biologically related diseases) and attempting to compare studies on the combined patients will yield meaningless and confounded results if those definitions actually encompass disparate diseases.

There is a growing body of evidence that underscores the need to ask the fundamental question of whether “ME/CFS” definitions represent the same disease:

  • The P2P Workshop is focused on “extreme fatigue” as the defining characteristic of “ME/CFS,” but fatigue is a common but ill-defined symptom across many diseases. Further, not all “ME/CFS” definitions require fatigue or define it in the same way. For instance, Oxford requires subjective fatigue, and specifically excludes patients with a physiological explanation for their fatigue. But the ME-ICC does not require fatigue; instead it requires PENE, which is defined to have a physiological basis.
  • When FDA asked CFS and ME patients to describe their disease, we did not say “fatigue.” Patients told FDA that post-exertional malaise was the most significant symptom: “complete exhaustion, inability to get out of bed to eat, intense physical pain (including muscle soreness), incoherency, blacking out and memory loss, and flu-like symptoms.”
  • Multiple studies by Jason, Brenu, Johnston and others have demonstrated significant differences in disease severity, functional impairment, levels of immunological markers and patient-reported symptoms among the different case definitions.
  • Multiple studies have demonstrated that patients with PEM have impairment in energy metabolism and lowered anaerobic threshold, and have shown that patients with depression, deconditioning and a number of other chronic illnesses do not have this kind of impairment.
  • Multiple studies have demonstrated differences in exercise-induced gene expression between Fukuda/CCC patients and both healthy and disease control groups.
  • The wide variance in prevalence estimates shines a light on the case definition problem. Prevalence estimates for Oxford and Empirical populations are roughly six times higher than the most commonly accepted estimate for Fukuda. Even Fukuda prevalence estimates vary widely, from 0.07% to 2.6%, underscoring the non-specificity of the criteria. Nacul, et al., found that the prevalence using CCC was only 58% of the Fukuda prevalence. Vincent, et al., reported that 36% of Fukuda patients had PEM, representing a smaller population that would be eligible for diagnosis under CCC.
  • The work of Dr. Jason highlights the danger of definitions that include patients with primary psychiatric illnesses, especially because such patients may respond very differently to treatments like CBT and GET.

By contrast, there have not been any published studies that demonstrate that the set of “ME/CFS” definitions being examined in P2P encompass a single entity or biologically related set of entities. From Oxford to Fukuda to ME-ICC, there are significant differences in the inclusion and exclusion criteria, including differences in the exclusion of primary psychiatric illness. The magnitude of these differences makes the lack of such proof problematic.

Given that treating all “ME/CFS” definitions as a single entity is based on an unproven assumption of the clinical equivalence of these definitions, and given that there is ample proof that these definitions do not represent the same disease or patient population, it is essential that the P2P “ME/CFS” study start by asking this question:

Does the set of “ME/CFS” definitions encompass the same disease, a spectrum of diseases, or separate, discrete conditions and diseases?

The failure to tackle this cornerstone question up-front in both the agenda and the evidence review puts the scientific validity of the entire P2P Workshop at risk. If this question is not explicitly posed, then the non-ME/CFS expert P2P Panel will swallow the assumption of a single disorder without question, if for no other reason than that they do not know the literature well enough to recognize that it is an assumption and not established fact.


This post was translated into Dutch with my permission.


ME/CFS Mortality

July 7th, 2014 23 comments

Does ME/CFS kill? This critical question has received very little attention from researchers, but there is a way for you to help change that.

The first paper on causes of death in ME/CFS was published in 2006 by Dr. Leonard Jason, et. al. They looked at a registry from the National CFIDS Foundation, and compared the causes of death and ages of patients with general population data. They found that CFS patients who died of cancer, suicide and heart failure were significantly younger than people in the general population dying of the same causes. There are a number of limitations to the study, including selection bias of the cohort, but it was a very important signal that should have been investigated.

Despite calls from people like Dr. Lily Chu (read her CFSAC testimony on this subject from 2012), I’m not aware of any longitudinal or natural history studies collecting this sort of data. In 2012, Chang, et al. crunched numbers from the Medicare database and found an increased association with lymphoma, but again, there are serious limitations to that analysis.

Despite the dearth of good data, the IACFS/ME recently made the following statement in the 2014 revised Primer:

Even if patients get progressively worse, ME/CFS itself is not known to be fatal. (p. 26)

Dr. Chu offered a dissent at the recent IACFS/ME meeting, for a number of reasons. She said, in part:

We do not have evidence to say that ME is not fatal.  As far as I know, and please correct me if I am wrong, there are no longitudinal studies involving large ME/CFS populations that address this question. . . .

On the other hand, there have been cases, although rare, where death was attributed to ME. . .

The IACFS/ME is the only international scientific organization dedicated to ME/CFS. Anything we state should be evidence-based as much as possible. Statements surrounding mortality should be qualified to acknowledge the lack of and the need for more investigation.

So how do we resolve this? Two separate efforts are trying to determine just that.

At the recent IACFS/ME conference, Dr. Dana March presented data from the Chronic Fatigue Initiative’s epidemiology study. As reported on Phoenix Rising, of 960 survey respondents, 59 were determined to have died. The three highest causes of death were cancer (37.8%), heart disease (19%), and suicide (19%). That last number is pretty extraordinary, since in 2010 suicide deaths were 1.9% of deaths from all causes in the general population. Among cancer patients, suicide accounts for approximately twice that – 4% of all deaths. Granted, this is a very small sample size and the patients are drawn from ME/CFS specialty clinics. If the CFI data is confirmed in larger studies, suicide representing 19% of all deaths would be extraordinary.

One would think this would be a big enough signal to get the attention of CDC. We desperately need data on a large sample size to truly establish if people with ME/CFS have a higher risk of death from complications, from the disease process itself, or “secondary” causes like suicide (which is a primary cause to the person’s family and friends).

Natural history and longitudinal studies are expensive, in part because they need a lot of subjects and need to examine a long period of time. We will need CDC to do this work, or NIH to fund it, or NIH to fund the data platform recommended by CFSAC so that multiple researchers can do it. But we cannot and should not wait for government to get around to recognizing the need.

Enter Abby Brown (DePaul University) and Billie Moore (NJ CFS Association). Billie’s son committed suicide at age 46 after a 20 year battle with ME/CFS. Billie’s testimony on the subject is probably the most moving CFSAC public comment I’ve ever heard.

Now Billie and Abby have collaborated to create a comprehensive and detailed survey, with the goal of collecting more data in a more systematic way. The ME and CFS Mortality Study is IRB-approved and collecting responses now. If you know someone who passed away after having ME or CFS, then please consider participating in the study. The survey is very detailed, in order to collect complete details about the severity of illness and cause(s) of death. The estimated time required to complete the survey is one hour.

If you know someone who died after having ME or CFS, please participate. Feel free to share information about the study with other people you know, too. If you have any questions, you can contact Abby Brown at DePaulMECFSReseach AT Maybe this data will be enough to finally get the research we need.


Guest Post: Longtime Patient, New Advocate

June 30th, 2014 12 comments

I am very pleased to share this guest post from Darlene Prestwich in which she shares her experiences as a new(ish) advocate. I’ve been doing this so long, sometimes I forget what it was like to jump in the deep end of the advocacy pool. Darlene describes her own experiences with grace, and I am so grateful she is sharing them here today.


This week I’m home alone. My family is on an annual week-long camping trip to a neighboring state. Its incredibly painful sending them off to do things that I absolutely love to do year after year, but I don’t want ME/CFS to take those experiences away from them, too. So they stock the fridge before they leave and go adventuring without me. Last year I found it incredibly difficult to send them off. I was homebound and dealing with a particularly nasty and long-lived crash that looked as if it may be my new baseline. I had to spend much of the day in bed, being capable of self care but not much more. I was lonely, sad, and so very sick.

I could have reached out to friends, extended family, or supportive church groups, but I simply didn’t have enough energy for social interaction. That’s just one of the cruel tricks this disease plays. I decided to venture online and began to get a greater sense of the depth of the ME/CFS community there. Perhaps it was because I needed it so much right then (I’d dabbled around a bit before), but I was hooked. These people were speaking my language! Plus, I could rest mid-sentence if I needed to. Here were formerly active, capable, and successful people whose bodies and brains were so whacked out that simple physical or cognitive tasks could be overwhelming, and even lead to relapse. Many had been able to find a sense of acceptance despite the desolation of this disease and the toll it takes. Some were desperate and didn’t know if they could go on another day; they felt misunderstood, mistreated, and so very broken. It was both heartrending and encouraging and most of all, familiar.

At times going online was simply overwhelming. The combination of new terminology and technology I wasn’t very familiar with was daunting to say the least. It’s incredibly taxing to learn new things when your brain is a foggy mess. But the online advocacy community was so intriguing. Here was a group of people who were trying to rise up, be heard, and effect change. Most were doing it primarily from their beds. A few months into my forays online, HHS contracted with IOM to create a new case definition for ME/CFS. Suddenly I was signing petitions, writing letters, and urging family and friends to do the same. And all at once I went from being pleased that there was a group of people online who were speaking my language, to wondering just what language these people were speaking.

Things seemed to be in code. I’ve never been much for acronyms, and now I was swimming in them. Even Google was stumped at times. Adding to the confusion was how often simply rearranging the same letters meant something completely different: i.e. IOM,OMI, & IMO (or its perhaps more gracious variation, IMHO). Many a browsing session turned into an IAMGOTOBED experience. (Internet Acronym Mess Got Overwhelming, Tired Out Brain Ends Day)

Without advocates who were willing to educate me I would have been completely lost. There are many patient, inclusive, and kind people in this community. It takes work to bring someone up to speed, and it’s a steep learning curve for an absolute beginner. I am very appreciative of those who were—and continue to be—willing to use precious energy to answer my sometimes incredibly basic questions. The more I learn about the history of ME/CFS, the more my admiration grows for those who have been advocating tirelessly for years. (Well, maybe not tirelessly, but in spite of being profoundly tired.) There are also many who have worn themselves out trying to be heard.

These were people with strong opinions who felt passionate about their cause, but who didn’t always agree. The IOM contract was hugely divisive, and it was disconcerting to see how viciously some advocates attacked other advocates. It seemed so counterproductive, especially within a movement which faces the unique challenges this one does. It has been said that advocacy is a messy business and those who want to contribute should put on their “big girl pants” and grow a thicker skin. I’m sure that can be helpful advice, but it seems doubly challenging for people who are often so ill they rarely even put on pants. On the other hand, I’ve watched advocates who were sharply divided quickly leap to other’s defense when attacks came from without the community. I got the sense that this community feels sort of like a family.

I was enjoying this business of being an advocate. I was getting a better grasp of the technology, and with repeated use the terminology wasn’t so intimidating either. Then I ran across an opinion that gave me pause. Someone had posted that there were too many people claiming the title of advocate. They suggested that signing petitions and writing letters Does Not an Advocate Make. Well, I’m not a lobbyist or a lawyer, and I haven’t started a patient organization. I don’t run a support group or make films. I don’t even have a blog. So… maybe I’m just some sort of a wannabe advocate. I suppose the answer lies in how one defines ‘advocate’. I do know that I am advocating. And at times it comes at a substantial personal cost; it doesn’t take much to do that, unfortunately. But it feels good to be doing something; and for now I suppose that will have to be enough.

Through all this I’ve become more open about my illness with my friends and extended family. I’ve appealed to government representatives and become more willing to attempt to educate my various healthcare providers. After all, it takes courage simply to admit I have an illness as lame as Chronic Fatigue Syndrome sounds. And although Myalgic Encephalomyelitis now trips easily off my tongue, even my closest family has yet to master that mouthful consistently. I also feel a much greater responsibility to fight for others who are suffering, as well as those who will be stricken down by this devastating disease.

So this week will be quiet, and a bit lonely. But I’m pleased that I have new friends and acquaintances that I didn’t have last year. Many are, without a doubt, Completely Legitimate Advocates. I still have so much to learn, and not nearly enough capacity to do everything I would like. But I’ve come to believe that my voice is important. After all, imo we need every voice we can get.

Parsing CFSAC

June 24th, 2014 17 comments

tangledthreadsI feel like a broken record, saying that the June 16-17th CFS Advisory Committee meeting was frustrating. This meeting struck me as a tangle of threads that can only be understood by teasing them apart. There were signals buried in the discussion that should raise concern in the advocacy community. Rather than summarize the content of the entire meeting, I would like to parse some of the issues with you.

Toothless Recommendations

Watching group wordsmithing is always incredibly painful. I know many patients got frustrated during the Committee’s discussions of their recommendations. Despite the fact that Dr. Dane Cook’s group presented a comprehensive summary of the Researcher Recruitment Working Group rationale and well-drafted recommendations, the conversation still went off the rails a few times. Rather than recap the whole thing, I’ll just focus on the recommendations themselves.

The first recommendation was for NIH to fund and support a data platform for biobank and clinical data. The idea is based on the NDAR platform, and Dan Hall gave a great presentation on NDAR but not until after the CFSAC had already passed the recommendation. As a result of this backwards agenda, the CFSAC failed to discuss or include a very important element: funding.

Dan Hall estimated that cloning NDAR for ME/CFS would cost about $1 million, and then somewhat less to maintain annually thereafter. The CFSAC recommendation does not include the price tag for the data platform, and no one discussed the feasibility of requesting this kind of funding. Remember that $1 million is 20% of NIH’s annual spending on ME/CFS research. How likely is it that NIH will spend this kind of money on a data platform for us? I strongly support the recommendation, as a data platform like this is desperately needed and none of the non-profits have the resources to make it a reality. But even with the background support document drafted by Dr. Cook’s Working Group, it seems optimistic to believe that NIH will approve this in the short term.

The second recommendation for an RFA was very controversial, and discussed on both days. The original proposal was that the Trans-NIH ME/CFS Working Group, led by Dr. Mariela Shirley, would recommend the content of an RFA based on the P2P Workshop and the 2011 State of the Knowledge meeting. CFSAC member were appropriately concerned about voting for an RFA based on a document that won’t be written for many months. There was extensive argument, but a motion to remove the reference to P2P failed. Chris Williams (Solve ME/CFS Initiative) pointed out that the recommendation would be “toothless” without a dollar figure, but that was ignored.

There was also great controversy over whether to include a deadline for the RFA. A minority of the CFSAC members felt that including a date would kill the entire recommendation. One suggested deadline was December 31, 2015, but Dr. Alisa Koch (new CFSAC member) pointed out that this would mean grants would not even be reviewed until 2016, let alone funded. Eventually, the CFSAC amended the recommendation to state a deadline of “November 1, 2014, or as soon as feasible.” I agree wholeheartedly with the CFSAC members who pointed out that the “as soon as feasible” would be used by NIH to delay the RFA until whenever it sees fit.

Finally, the CFSAC voted to establish two new working groups. The first, suggested by Dr. Jose Montoya (new CFSAC member) will develop a case for Centers of Excellence. This is a long standing and much repeated recommendation of CFSAC, and developing the case for it will be fantastic.

The second working group, suggested by Dr. Gary Kaplan, will examine ways to interface with Patients Like Me and push that out to the community. I was really surprised by this. While the presentation by Patients Like Me was impressive, Ben Heywood admitted that PLM has not invested any effort in building out the ME/CFS community there. There are multiple problems with the way ME/CFS is defined and measured on PLM. And not a single person raised the issue that PLM is a for-profit company. They aggregate and sell their data. I don’t see how the federal government (directly or through CFSAC) can undertake a project that will specifically benefit a single for-profit company.

The worrying signal here is the Committee’s failure to make its recommendations based on a full assessment of all the facts and a view of the overall landscape. Dr. Cook’s Working Group presented the best prepared recommendations we’ve seen in quite some time, but the failure to include target numbers and meaningful deadlines continues to be a problem.

Compromising to Get Along

The most disturbing thing about the meeting was the conflicting approaches of the CFSAC members. This was most on display during discussion of P2P and the RFA recommendation.

Dr. Cook explained that the reason the RFA recommendation included a reference to P2P was because the group believed NIH would wait for the P2P regardless of what CFSAC said. Therefore, the recommendation should just accept P2P as a done deal in order to avoid antagonizing NIH. Dr. Cook and Dr. Casillas, backed up by Dr. Nancy Lee, said the recommendation would fail otherwise. NIH has apparently sent a letter to IACFS/ME responding to their RFA request, and Drs. Friedberg, Cook and Lee all said that the letter states NIH will wait for the P2P before issuing an RFA (I haven’t seen this letter).

This conciliatory view was expressed most frequently by Dr. Gary Kaplan and Dr. Fred Friedberg (IACFS/ME). I copied down multiple statements from both. Dr. Kaplan said that CFSAC should be “more aligned” with NIH, making a “polite suggestion.” He said CFSAC should “be collegial so they’ll want to work with us.” He also said we have “nothing to fear” from P2P.

Dr. Friedberg was more emphatic. He said that the recommendation should not exclude something just because we might not like it, and that he doesn’t like us vs. them thinking. He said that the recommendation should “eliminate implicit antagonism,” and, “I don’t like the demand quality.” Regarding the prospect that CFSAC (or advocates) may not like some or all of the IOM and/or P2P recommendations, he said we should “make lemonade” rather than engage in  “wholesale condemnation.”

The opposing view was expressed by Steve Krafchick, who said Dr. Kaplan’s collegial approach was “naive.” Dr. Mary Ann Fletcher specifically responded to Dr. Kaplan’s comment as well, saying that the CFSAC charter doesn’t say anything about getting along with NIH. She said that the Committee’s job was to advise the Secretary as experts in the field, and they they were not being fair to patients by putting things off to be collegial.

There was an inherent contradiction in the research recommendations, too. The recommendation on the data platform was passed with no discussion of cost or likelihood of success. There is a need for a data platform, so the Committee recommended it – and that is as it should be. But for the RFA, the majority felt that P2P should be accepted as part of the process simply because that is how NIH appears to be doing business, regardless of the fact that everyone agreed that RFA funding was needed now.

The worrying signal here was identified by Mary Dimmock (from the audience). She pointed out that it was a dangerous precedent to put forward recommendations that seemed likely to succeed, as opposed to the best recommendations that are most needed. I could not agree more. CFSAC’s job is to give the Secretary the best advice, not the advice that the Secretary or the agencies want to hear.

Moving forward . . . . together?

The last session of the meeting was facilitated by Deputy Assistant Secretary Anand Parekh. I was fascinated by the move to bring him in to lead this discussion. Was this a tacit recognition that Dr. Nancy Lee has had difficulty facilitating discussion about IOM, like the awkward session at the December 2013 CFSAC meeting? The other new development was an actual open forum. In the past, “open” discussion with the audience has been limited to the Chairman selecting questions that have been written on index cards. In this case, members of the audience were handed a microphone and they could address the Committee directly. I wish this had been more widely publicized (a simple email on the CFSAC listserv would have sufficed). I am probably not the only person who would have risked the health consequences to attend for that opportunity. Several prominent advocates had left the meeting by then, as well.

Margaret Jacobs from the American Epilepsy Association presented on the epilepsy community’s experiences with their own IOM report and subsequent cooperation with HHS. Because a number of epilepsy organizations helped fund that IOM study, they had input into the statement of work, received monthly status calls, and received the recommendations a week before public release so they could prepare their messaging. The cooperation before and during the IOM process laid a strong foundation for continued cooperation afterwards, with the epilepsy community and HHS working together.

The same is true for our situation: what happened before the IOM study is setting the stage for what will come after. HHS pursued the IOM study in secret without involving the stakeholders outside the federal government. The ME/CFS advocacy community found out about the contract by accident, and when we protested, HHS simply changed the contract mechanism to one that did not require public notice. There was no collaboration, no engagement, and communications were terrible.

Now HHS seems to think we can all come to the table and work together. I am deeply troubled by the fact that the government holds all the cards here. They will have about a week to prepare messaging on the IOM report, while we will have no opportunity to do so. The P2P report is issued pretty quickly after the meeting, but NIH will be in control of the press conference push behind the report. This simply isn’t creating a dynamic where the stakeholders can actually collaborate. I’m not sure if it will be possible, and the content of the IOM/P2P reports is only one factor in the way.

The worrying signal here is the open question of whether HHS actually wants to change the paradigm and is willing to do the work necessary. Dr. Lee said they “don’t want to do this without [community] involvement,” but if she means the kind of involvement we have had to date, then there is nothing to really talk about. It is going to take a great deal of work on both sides to change the trajectory here.

Dr. Parekh said twice that “there is a lot of angst among patient groups about IOM.” It’s not angst. We have legitimate scientific and policy concerns. Angst is easily dismissed as unreasonable anxiety. I do not know if HHS understands and appreciates the difference.


P2P: Taking Shape

June 20th, 2014 13 comments


The P2P ME/CFS Workshop has been approved and is scheduled for December 9-10th, 2014. The focus of this post is on analyzing four components of the information released by NIH yesterday:

  • P2P is describing our disease as fatigue, without post-exertional malaise
  • P2P is trying to clarify questions on the multiple case definitions, measurement tools, effective therapies and innovative research methods
  • The P2P agenda uses questions beyond the evidence review, but not the most important question of all
  • The P2P Working Group includes members with and without ME/CFS expertise


How Does P2P Describe ME/CFS?

Huge red flag, folks. Here is how the P2P website describes ME/CFS:

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a complex, multifaceted disorder characterized by extreme fatigue and a host of other symptoms that can worsen after physical or mental activity, but do not improve with rest. In addition to extreme fatigue, people with ME/CFS may also experience:

Widespread muscle and joint pain

Sore throat

Tender lymph nodes in the neck or armpit


Sleep problems

Difficulty with short-term memory or concentration

I added emphasis so you can’t miss the takeaway here. ME/CFS is characterized by extreme fatigue, and people with ME/CFS may also experience other symptoms. And what is missing from this list? POST-EXERTIONAL MALAISE. Even Fukuda lists post-exertional malaise as an optional symptom. But the way NIH has described the disease, it almost sounds like Oxford – extreme fatigue and maybe other symptoms.

The description also states, “sensitivity to environmental factors (e.g., noise, light, chemicals) may force many individuals with ME/CFS into seclusion or withdrawal from society.” These sensitivities can certainly be debilitating, but I think most (if not all) patients would agree that it is primarily PEM and all the other symptoms that keep us imprisoned in our homes or our beds.

Need more proof that NIH’s conception of ME/CFS does not question the assumption that they are the same fatiguing illness? They say the two names are for the same condition: “The name myalgic encephalomyelitis or ME is more commonly used in Europe and Canada, while the name chronic fatigue syndrome or CFS is used more often in the United States and Australia. Yet the acronym ME/CFS is increasingly being used worldwide.”

In all fairness, these descriptions do not automatically determine what the Panel’s report will say. But the paradigm of a single, fatiguing illness has been at the heart of my opposition to the way P2P was being put together, and this has not eased my concern.

What Will P2P Try To Do?

The P2P website describes four things that the Workshop will try to clarify, a weird sort of blend between the five questions presented by Dr. Susan Maier to IOM on January 27, 2014 (after the P2P Working Group planning meeting), and the Key Questions of the systematic evidence review protocol.

The first issue is how the research using multiple case definitions has contributed to the state of the current literature. It’s a good question, but the answer seems blindingly obvious. Perhaps there are more subtleties that outsiders would see that I do not. All I can see is the absolute muck of a contaminated evidence base that counts Oxford studies and CCC studies as one and the same, and has absolutely no consensus on how to diagnose or measure any of it. In my opinion, the use of multiple case definitions is responsible for the state of the current literature, which is why we are stuck in a hellish stalemate with no widely accepted criteria, biomarkers, or treatments.

The second issue is how measurements are able to distinguish among ME/CFS patients focused on subsets by duration, severity, onset, and “nature of the illness.” Two observations. First, what is “nature of the illness”? I do not understand whether this is referring to immunological vs. neurological, or something else. Second, this issue assumes that differences are automatically subsets! This is exactly what I’ve been harping on for months – that the failure to ask if ME and CFS are the same, different, or spectrum illnesses eliminates the most fundamental and foundational question of them all.

The third issue presents a big red flag. It asks how research on “therapies shown to be effective” will lead to an understanding the underlying pathology. What therapies have been shown to be effective? Are we talking CBT and GET? Rituximab? You will get two very different answers about underlying pathology if you consider CBT/GET to be effective instead of Rituximab (and vice versa). Just last week, the Solve ME/CFS Initiative told NIH that the search strategy will bias the evidence towards CBT and GET. If that prediction holds true, then asking what CBT and GET tell us about the underlying pathology is patently dangerous.

The fourth issue asks what “innovative research approaches” tell us about the pathophysiology of ME/CFS and how it can be used to develop treatments. What is an innovative research approach? Is this where Rituximab fits in? Or is this focused more on things like proteomics, microbiomics, or systems network analysis? Or something else? Without understanding the terms or context, it’s hard to tell.

Agenda Good or Agenda Bad?

You may recall that I got two draft agendas for the Workshop through FOIA. Circumstantial evidence suggested they were drafted at or soon after the January Working Group meeting. How do they stack up to the real thing posted on the P2P website? Answer: the draft agenda I got through FOIA is very very similar to the one posted yesterday.

A few overall observations: The time officially allocated to the “patient perspective” is 20 minutes. The Evidence Practice Center has a total of 1 hour, 20 minutes split between two days. Total time allocated for discussion: 2 hours, 40 minutes split between the two days. You may recall that Dr. Shirley said at CFSAC that there would be town hall-style discussion at the Workshop, and also said there would be “public testimony” but provided no details on that. With less than three hours for discussion, I expect tight facilitation as opposed to open mic. There is no indication of anything resembling “public testimony” as we know it from CFSAC or other federal meetings.

I must call out one change in particular. You probably recall that I have been decrying the framing of Dr. Maier’s overview of the topic, described as “Overwhelming fatigue and malaise as a public health problem.” On the agenda posted by NIH, Dr. Maier still has 20 minutes to present an overview, but that description of the overview is gone.

The five Workshop questions are identical to the draft agenda I obtained through FOIA. Here they are, with their sub-topics (each one gets 20 minutes), but I’ve left off EPC presentations and discussion time.

I.  What is the Incidence and Prevalence of ME/CFS, and Who Does It Affect?
a) Incidence and Prevalence Data (Population-Based Studies)
b) Social Determinants of Health
c) Disease Across the Lifespan

II.  What Tools, Measures, and Approaches Help Define Individuals with ME/CFS?
a) Overview of Existing Tools and Measures
b) Measures: Patient-Reported and Physiologic
c) Measures: Omics, Biomarkers and Imaging
d) Innovative Statistical Approaches

III.  How Are Tools and Measures Used to Distinguish Subsets of Patients with ME/CFS?
a) Identification of Subsets of Individuals
b) Triangulating Quantitative and Qualitative Data (Quality of Life/Function)
c) What Outcomes Represent Improvement, Recovery, Prevention, Benefits, or Harms

IV.  Given the Unique Challenges to ME/CFS, How Can We Foster Innovative Research to Enhance the Development of Treatments for Patients?
a) Incorporating Multiple Study Designs into ME/CFS Research
b) Maximizing Approaches and Results from the Study of Other Illnesses and Complex Chronic Conditions
c) Using Research on Comorbidities to Understand ME/CFS

V.  What Does the Research on ME/CFS Tell Us About the Presentation and Diagnosis of ME/CFS in the Clinic?
a) Lessons from Current Treatments and Clinical Trials
b) Comparative Effectiveness Research
c) Health Services Research and Health Policy Relevant Research

I’m going to wave a few big flags here (you knew I would). First, this agenda does not ask if CFS and ME are the same illness, different illnesses, or different aspects of a spectrum. Does. Not. Ask.

You cannot answer a question if you refuse to ask it in the first place. If we have a pile of apples and oranges and we insist on talking about the incidence and prevalence of a fruit called “appanges,” for example, or the tools that will help distinguish the subsets of “appanges,” are we ever going to question whether “appanges” are actually a pile of apples and oranges????? No, we are not. We will continue to call them “appanges,” and argue about whether the number or shape or color of the seeds distinguishes subsets. We will not see what is right in front of us, because we did not bother to consider that “appanges” might be a made-up category of fruit truthiness.

Second, we keep hearing mixed messages about what this Workshop is really trying to accomplish. Is it to identify the gaps in research, as many people insisted at CFSAC? Is it to identify methodological weaknesses in the research, as Dr. Cook said on Tuesday? Is it to determine what treatment or clinical approach works best? I see shades of all three, with an emphasis on what is known and not what is unknown.

I must correct something I have been insisting was true. I have been saying that the agenda would mirror the questions for the systematic evidence review. That was incorrect. But while the agenda and systematic review questions are not identical, you can draw a lot of lines back and forth to connect one to the other.

When Carol Head (Solve ME/CFS Initiative) expressed concern at CFSAC about the elimination of the question of how CFS and ME differ, Dr. Collins Sharp – answering with the caveat that she is not at all involved in the P2P planning – said that the review questions are a subset of the Workshop questions. She said that any question that did not have sufficient literature to be included in the evidence review could still be addressed at the Workshop. This appears to be the case, but that most important and fundamental question is nowhere to be seen.

The P2P Working Group

The P2P Working Group is the committee that helps NIH plan the meeting. The Group met in person at NIH January 6-7, 2014 (that meeting agenda has been posted). Before now, the P2P Working Group roster was only available through FOIA. Here’s the breakdown of the full list:

Federal Employees, familiar with ME/CFS (6): Dr. Susan Maier (NIH), Dr. M. Katherine Jung (NIH), Dr. Janet Maynard (FDA), Dr. Eun-Chung Park (NIH), Dr. Leorey Saligan (NIH), and Dr. Mariela Shirley (NIH). The NIH employees are all members of the Trans-NIH ME/CFS Working Group. Dr. Park is the staff member contact for the Lipkin samples. Dr. Saligan’s research focus is acute and chronic fatigue, and he has done sample analysis for Dr. Baraniuk and others. Dr. Maynard is the FDA ex officio to CFSAC, and works in the FDA review division that handles ME/CFS drug applications.

Federal Employees, not familiar with ME/CFS (6): Jody Engel, Deborah Langer, Elizabeth Neilson, Wilma Peterson Cross, Paris Watson, and Dr. Jessica Wu all work at NIH’s Office of Disease Prevention. They also all serve on the P2P Working Group for the upcoming meeting on opioid use.

Non-Federal Members, familiar with ME/CFS (6): Dr. Mady Hornig (Columbia University), Dr. Leonard Jason (DePaul University), Dr. Nancy Klimas (NOVA Southeastern University), Robert Miller (Patient and Advocate), Dr. Peter Rowe (Johns Hopkins University), and Dr. Suzanne Vernon (Solve ME/CFS Initiative) are all familiar to the ME/CFS community.

Non-Federal Members, not familiar with ME/CFS (1): Dr. Carmen Green (University of Michigan) is an anesthesiologist and member of the HHS Interagency Pain Research Coordinating Committee. She is the chair of the P2P Panel.

Several names listed on the January roster (obtained through FOIA) as attending the meeting do not appear on this final Working Group roster. Missing are Dr. Suchitra Iyer (AHRQ), Dr. Heidi Nelson and Dr. Beth Smith (both of the Oregon Health & Science University Evidence Practice Center). I do not know for certain why they are not listed on the final Working Group roster, but they may have attended the meeting to discuss the evidence review questions rather than the planning as a whole.

Another odd omission: at the CFSAC meeting, Dr. Nancy Lee said that Marty Bond had attended “several” of the meetings for P2P. Yet Ms. Bond’s name is not listed on any of the documents posted or obtained through FOIA. So we cannot automatically assume that the only people attending Working Group meetings are the members themselves.

According to the P2P website, the Working Group drafted the questions for the evidence review, finalized the agenda, nominated speakers and panelists, selected the workshop date, and continue to be engaged in ongoing workshop planning. I am hearing conflicting things about that continued engagement and how extensive it will be.


Based on the information released yesterday, is P2P a worst case scenario? I have a vivid imagination, so I can definitely imagine something worse than this. But is P2P looking good? Absolutely not. If Mary Dimmock and I were writing our letter to Dr. Collins today, I would tweak some sections but all of my objections are basically unchanged.


Guest Post: CFSAC Testimony of Andrew Bokelman

June 19th, 2014 5 comments

Andrew Bokelman was scheduled to deliver public comment to the CFS Advisory Committee on June 17th and was the first telephone commenter. His call was terminated by the operator prior to his 3 minutes being up. After protest on Andrew’s behalf from CFSAC members, Marty Bond apologized to Andrew and he was given an additional minute to speak (which he discovered only because he accidentally had not terminated the call). We also learned that written comments from the public were not provided to CFSAC members as per usual. Andrew gave me permission to publish his comments in full.

Hello. My name is Andrew Bokelman.

The HHS told us they welcome outside research about ME/CFS, but we should make sure it is evidence-based. This makes sense to me. And so now I call on the HHS to do the same. To make sure your information is evidence-based. I also ask that the HHS commit to being evidence-based, even if you have to retract something you said before, or remove it, or stop it.

And this brings me to the IOM contract. I looked at the IOM’s past work with CFS. It is not evidence-based, even when this is required. An example is the gulf War Syndrome treatment guide, which contains a section for treating Chronic Fatigue Syndrome. The section recommends exercise, and to support this they reference a journal article that doesn’t mention CFS. They reference an institutional web-based guide that cites no evidence. They reference the 1994 Case Definition, which says nothing about exercise. So at best, the IOM is speculating while looking at secondary resources. This is not evidence-based research.

I invite you to look at the hard copy of my testimony. I documented the few examples I gave. Spot check these to confirm what I said. Then contact me and I’ll demonstrate that the rest of the treatment section does not consist of sound evidence-based research.

Or maybe you think what I say cannot be true, so no need to check. After all, the IOM is a high-profile research center that uses hand-selected panels whose work is reviewed by a separate review board. But look more closely. The review board cannot compel the primary panel to correct their choices. It can only suggest they do. Nor can they review the final draft. I confirmed this with IOM staff. They defend their laissez-faire method of quality-control by saying it preserves the independence of the panel. But the proof is in the product. And their product is not evidence-based.

Now, you could just ignore what I say and hope this won’t be one more IOM disaster. But keep in mind, there is no way to undo this, once it is complete. So I call on the CFSAC and the HHS representatives here to do the right thing. Check my hard copy to see if what I said is true. And then follow up with me. Please don’t dismiss my involvement because I’m a member of the public. I worked as an analyst for 20 years, and I am the one person who can articulate my reasons for believing the rest is not sound evidence-based research. The IOM is really not qualified to handle this project, and government regulations provide a way to terminate the contract.

Thank you for letting me speak.


1. Gulf War and Health: Treatment for Chronic Multisymptom Illness By Board on the Health of Select Populations, Committee on Gulf War and Health: Treatment for Chronic Multisymptom Illness, Institute of Medicine.

You can obtain a free pdf version at this site: All you have to do is register, and then you will have access to the PDF version. The CFS treatment guide begins on page 99.

2. Harber, V. J., and J. R. Sutton. 1984. Endorphins and exercise. Sports Medicine 1(2):154-171. (accessed November 11, 2012).

This is the journal article that doesn’t mention CFS. It did not report research on CFS. At best, the IOM is speculating, not presenting evidence.

3. CDC. Undated. Chronic Fatigue Syndrome: A Tool Kit for Providers. (accessed November 13, 2012).

This is a web resource that contains no evidence. It is not a primary resource. And it is also the same Tool Kit that the CFSAC recommended be removed from the CDC website (see the recommendation here:

4. CDC (Centers for Disease Control and Prevention). 1994. Chronic Fatigue Syndrome: The 1994 Case Definition. (accessed November 13, 2012).

This the 1994 definition of Chronic Fatigue Syndrome. The 1994 criteria (and the web page they are on) says nothing about exercise, one way or the other.