The good news, I guess, is that we survived another CFS Advisory Committee meeting. The bad news is that much of what happened made no sense to me. Some excellent summaries of the meeting are available, including this very detailed recap from Phoenix Rising. I would like to tackle a few of the topics that had me shaking my head, or asking myself if my experience of reality is so at odds with the Committee’s. This post is long, and I apologize for that. Here’s my report card on these head-scratcher issues:

Meeting Mechanics

I know how difficult it is to prepare for and moderate two full days of contentious meetings, and I imagine it is more difficult to do so when the meeting will be held in public. However, I was struck by how poorly some of the administrative aspects of this meeting were conducted. For example, the procedure for meeting and comment registration is unnecessarily complicated for a patient population that struggles with multiple forms of cognitive dysfunction. I hope this can be simplified.

On the first day of the meeting, Dr. Gailen Marshall said that members would be limited to three minutes for comments during discussion. He did not enforce this limit evenly, including on himself. More than one observer noted how long his own comments were, and how he sometimes monopolized discussion. I happen to think that a Chairman needs leeway to cover certain topics, but sometimes this seemed excessive. Participation by other Committee members is very uneven: Eileen Holderman, Dr. Mary Ann Fletcher and Steve Krafchick speak most frequently; Dr. Jordan Dimitrikoff and Dr. Susan Levine fall somewhere in the middle; Dr. Adrian Casillas, Dr. Lisa Corbin, Dr. Dane Cook, and Rebecca Collier rarely if ever spoke. It did seem like the non-voting liaisons were integrated into the discussion, and had opportunities to ask questions and offer feedback.

I was very frustrated by the evident lack of preparation for even simple agenda items. For example, when approving the list of ME/CFS organizations for linking on the Office of Women’s Health website, the Committee did not have a list in front of them and they approved the criteria on Day 2, after approving the list on Day 1. One of the criteria was that organizations would consent to being linked, but on Day 1 Dr. Lee said that was not checked, so the criteria list on Day 2 had to be amended. It was a mess, and hard to follow. A similar lack of preparation was evident in the discussion of the High Priority List, as we’ll see. There is simply no good reason for the lack of preparation. Why didn’t a staff member type up the list of criteria and list of organizations, provide it to the Committee and post as a slide, so everyone knew what they were voting on? The disorganization and confusion wastes time, at the expense of other issues.

One mechanic that worked fairly well, in my opinion, was the audience Question & Answer. The audience questions led to some very significant discussion, especially regarding CDC. Some people feel that Dr. Marshall should not curate these questions, and I thought that the “answer” discussion tended towards domination by the Committee instead of actual answers to the questions. However, I think the value of this kind of interaction was very clear and I hope this will continue.

High Priority Recommendations

From a procedural perspective, we scored a small victory here. Dr. Marshall acknowledged that the list was not handled correctly last year. I pressed the Committee to devote an appropriate amount of time to discussion of the list, and I was shocked when they agreed. I don’t know what happened at lunch, or who said what, but apparently there was enough concern expressed that Dr. Marshall said they would move the discussion to Day 2. They discussed the list and how to use it going forward, and voted on it in public as required by FACA. Procedurally, they handled the issue correctly.

But the substance of their decision is perplexing, at best. No list was posted, and it did not seem like the committee members had a single piece of paper in front of them with the full list. Items were added – but without reading some of the additions into the record – and a process for removing items was discussed but not used. Dr. Marshall downplayed the fact that several recommendations had been altered from the original form, saying that “the spirit is there.” Dr. Lee said that the old recommendations chart would now be a historical document, and the High Priority list would be the working list. Dr. Marshall said that of the eight recommendations the Committee made last year, three were complete and the other five would be added to the list. But he did not specify which recommendations he considered complete, and no one asked him to be specific. I can make a pretty good guess, but we won’t know for certain until the final list is posted.

And amid all this back and forth, Dr. Marshall said that the list was never intended to prioritize one recommendation over another within the list. Everything on the list is of equal importance. No one questioned or objected to this. This may not seem like a big deal, but it is. By acquiescing to this equal priority description, the Committee created a situation where holding a disability workshop is of the same priority and importance as holding a case definition workshop. I don’t think most members would agree with that statement, but now they’re stuck with it.

So what did they select as the high priority recommendations? The Committee combined the original seven recommendations on the January 2012 list, five of the eight recommendations made in 2012, and two recommendations added by Eileen Holderman. These items are listed in chronological order. New recommendations will be added to the list automatically, and the Committee will have to vote to remove an item once they are satisfied with the response from the Assistant Secretary. I’ve drafted my best guess at the specific recommendations they approved (given the lack of precision on the 2012 recommendations), and I’ll post the official version when it becomes available. Is this list ever going to matter? Technically, I think it matters a great deal but I’m not sure the Committee shares that view.

Invisible Information

One of the things I said we should watch for at the meeting was any mention of the Ad Hoc Workgroup. Guess what? They never mentioned it once. This is one of the things that has me questioning if my reality is different from the Committee’s. Dr. Lee made such a point of talking about the Workgroup in 2012, and their report was published in March. But at this meeting? Total silence. It’s as if the Workgroup doesn’t exist. And not a single Committee member brought it up or asked a question. Why? What is the status of this group? What did the Committee think about the report? Did they even READ the report? Am I the only person who thinks this is strange?

The other thing that received almost no attention is the response from the Assistant Secretary to the Committee’s October 2012 recommendations. This was posted to the CSFAC website shortly before the meeting (pdf link). Again, I don’t understand why the Committee doesn’t simply review these at the outset. Instead, the only discussion was when Steve Krafchick objected that the response to the recommendation to hold a case definition workshop was not actually responsive (see the discussion on case definition below for more details).

The risk of ignoring or glossing over the official responses to CFSAC recommendations is that we miss opportunities to understand the basis for those responses. For example, buried on page 3 of the response is this statement: “To date, CDC has not been able to confirm the occurrence of outbreaks of CFS.” This leaves me wondering how in the world CDC characterizes the outbreaks at Incline Village and Lyndonville. But because the Committee does not discuss the responses, these questions don’t get raised. If I write to CDC or submit a question for the next PCOCA call, I will probably be ignored. But a CFSAC member could ask these questions and get answers on the record. Instead, this information – and the opportunity to learn even more – is effectively invisible, and it has no apparent effect on Committee members and discussion.

Oh CDC, You So Crazy

The CDC’s report of activities was ho-hum, dry, and devoid of much of interest. It was not until the Q&A sessions that we actually learned anything important.

The very first question was whether CDC would use the two-day cardiopulmonary exercise testing in phase 2 of its multisite study. Dr. Unger said that the clinicians in the multi-site study felt a two-day exercise test was “not advisable.” She elaborated that patients travel some distance to get to the physicians involved in the study and that a two-day test was not feasible. It was not clear to me whether the concern was the time required or the physical impact on the patients. I was very surprised that the clinicians (Natelson, Klimas, Peterson, Kogelnik, Bateman, Lapp, Podell) were the ones who advised against using the test because most (if not all of them) have used two day testing for some of their patients. Steve Krafchick pressed Dr. Unger, stating the importance of two day protocols for exercise and neuropsych testing in order to objectively capture the effects of post-exertional malaise. Dr. Unger said they would rely on questionnaires for functional outcomes and the clinicians’ observations of clinical course. Krafchick said it was a mistake to eliminate the testing, and asked if Dr. Unger had talked to Dr. Chris Snell. Dr. Unger said, “No.” My jaw hit the floor. How could it be that Unger has never talked to Snell about CPET? They’ve been at meetings together, including the recent FDA meeting where Snell gave a presentation on two-day CPET. I still can’t wrap my brain around this. Two day CPET provides objective evidence of metabolic dysfunction, post-exertional malaise and estimate of disability. CDC, how could you refuse to use this test?!

Another great question for CDC was whether the website would include a highlighted warning that exercise can be dangerous for ME/CFS patients. Dr. Belay answered that the website states exercise can exacerbate the illness, and Dr. Marshall asked about the equivalent of a black box warning. Dr. Belay said they could consider it. Dr. Fletcher followed up with a reminder that the Toolkit recommends exercise as a therapy, and Dr. Belay said CDC has revised the Toolkit and it is going through clearance. My jaw hit the floor again. Why didn’t Dr. Belay think to mention that in his routine report? It’s obviously of interest to the Committee since they recommended last year that the Toolkit be removed from the website. I guess Belay was planning to wait until the revision was complete, because when Steve Krafchick asked if Committee members could see it for review or comments Dr. Belay responded, “Why?” and “we don’t do that.” Seriously? Dr. Marshall pointed out comments could be useful, and Dr. Lee said they could send informational copies to interested members for feedback.

The Committee discussed a review of the CDC website, including the photos which portray people yawning at work, going for slow walks, etc. Several committee members (and many patients) feel the photos are misleading because they do not portray the seriousness of the illness. Dr. Unger responded that they want to portray a “positive” side. Seriously? To be frank, it is conversations like this one that make patients wonder what planet CDC lives on that they think there is a positive or lighthearted side to ME/CFS. The discussion moved into case definition because the CDC website and medical education material lists multiple criteria, including the maligned Oxford definition, even though CDC says it endorses and uses Fukuda. There was more discussion of the 2-day CPET, whether the Canadian Consensus Criteria is difficult to use, and whether there was enough information to endorse the Canadian Criteria immediately as many advocates insist. Unfortunately, and typically, there was no resolution on any of these issues and case definition raised its ugly head again and again.

A Rose By Any Other Name . . . .

So we come to case definition. In October 2012, the CFSAC recommended that the Secretary:

promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.

And the Assistant Secretary responded in writing on May 1, 2013:

The National Institutes of Health (NIH) is convening an Evidence-based Methodology Workshop process  . . . to address the issue of case definitions appropriate for ME/CFS research. However, it will not cover in detail a clinical case definition. The Office of the Assistant Secretary for Health, Department of Health and Human Services, is actively pursuing options for a separate effort that would work in coordination with the NIH process, but result in a case definition useful for clinicians who see patients with symptoms that may be ME/CFS. . . . .

The EbMW consists of a thorough, unbiased evidence review of the literature related to clinical research outcomes compared across case definitions and culminating in a workshop composed of experts and patients. The workshop participants and panel members will use the evidence review to evaluate the strength of evidence for case definitions with the goal of identifying the most consistent outcomes. . . . The first organizational meeting for the EbMW on ME/CFS was held on February 19,2013. A timeline for the process is being developed.

The wording of the response is very important: the EbMW will address the issue of case definitions appropriate for ME/CFS research. That does not say they will identify the correct or new research definition – just that the issue of appropriate research definitions will be addressed.

These two paragraphs from Assistant Secretary Koh’s response translate as follows: 1) No, we will not have a stakeholders’ workshop as you recommended in October 2012. 2) We will have an EbMW to address definition issues related to research. 3) We are “actively pursuing options for a separate effort” on a clinical case definition.

Understandably, several CFSAC members were upset that the answer was No-but-we’ll-do-something-else. This is what led to the fireworks at the end of Day 2. Several members reacted strongly to Dr. Susan Maier’s report that the unidentified people who attended the meeting on February 9th submitted a list of 35 to 40 potential candidates for the EbMW’s organizational committee to the Office of Disease Prevention for vetting and selection. Dr. Maier could not identify that list of candidates, although she did say that there were CFSAC members and advocates on the list. We have no timeline for publication of this list, either. Dr. Fletcher was particularly vocal about the secrecy and long timeline

I have to say that I am not surprised that the answer was “no, but . . . ” and I’m not knocking the EbMW. Dr. Beth Collins-Sharp from the Agency for Healthcare Research and Quality gave a detailed explanation of the methodology used for evidence reviews, and it is quite robust (and includes a patient viewpoint). I suspect that this is the same kind of evidence review that was requested by the CFSAC years ago in order to have a State of the Science Workshop, and which was never completed. The State of the Knowledge meeting in April 2011 was basically a State of the Science-Light kind of meeting. AHRQ’s last review on CFS was completed in 2002, so it is certainly time for an update.

The problem here is that we don’t have enough information to judge the EbMW process, since we don’t know who is on the organizing committee. We can’t judge the case definition process, since we have absolutely NO information about it whatsoever. And this leads to the real problem: THIS IS TOO SLOW.

As Dr. Wanda Jones reminded us in her welcoming remarks on Day 1, government moves slowly. It does indeed, and this creates extraordinary frustration for every patient and advocate involved. It seems unlikely (at this point, anyway) that the Canadian Consensus Criteria will be adopted as an interim measure, and none of the other case definition processes will bear fruit within the next six months. The government apparently expects us to wait patiently and calmly as this process unfolds at a bureaucratic pace. We don’t have a choice about the waiting part, but I don’t think the expectation that we will be patient and calm is realistic at all. This issue is too huge, too important, too divisive, and too slow. People are angry and will continue to be so, unless the government can demonstrate urgency.

If anyone from HHS is reading this post, may I suggest that you improve the way you communicate around this issue as a first step? The FDA communicated openly with us, and also produced a great meeting. Look to FDA for ways to productively and positively engage the patient advocate community. If you don’t, we are likely to see fireworks of one kind or another at every CFSAC meeting going forward.


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24 Responses to Perplexed

  1. Kati D says:

    Thank you Jennie for this piece. i am also perplexe from the events that occured in the last half hour of Day 2 when Eileen said she was scared and that she was being coerced buy HHS and that she was under oath ( basically saying she was being forced to lie). CFSAC has been silent on this and this is highly disturbing, perhaps showing us a bit of what is happening behind the scenes.

    • Jennie Spotila says:

      Thanks Kati. I wrote about that point where Eileen talked about being intimidated:

      I think it’s important to point out that she did not say she was being forced to lie. She said she took a pledge to serve on the Committee, and that she has always fulfilled that pledge. I agree that it is disturbing that we have heard no official word about this after the meeting. I sincerely hope there will be some kind of investigation.

  2. Thank you so much Jennie for this excellent summary. I’m so grateful for the work you do for all of us, especially those who cannot travel more than an hour from home (and some who can’t even do that). Do you know a site that gathers all the current definitions of ME/CFS in one place so that we could compare them? I’d love to be able to see that. It may be something I could write about…and I’d also like to talk to my doctor about it as a way to educate him about the confusion.

    Warmest wishes,

    • Jennie Spotila says:

      Thanks Toni! I am not aware of a single, easy to understand reference comparing the definitions. I’ve thought about writing it myself, but I’ve always felt a little intimidated. Can I interest you in collaborating on a project? I’m plotting out the next few months of posts, so I will see if there is space (meaning space in my brain) to work on that.

  3. Hi Jennie,

    It would be nice to collaborate on this at some point but I can’t undertake it right now because my new book is due out September 1st and so the “promo” (such as it will be) is going to heat up in the next few months. The publisher wants me to try and line up radio interviews and blogs that will host a question and answer with me…and the like. A big overwhelming for me.

    But perhaps some time down the road.

    @Jennie Spotila

    • Jennie Spotila says:

      No problem, Toni. I would love to host a blog interview on the new book, if you’re interested!

  4. I’d love to do that Jennie! If you have my private email address (I think you do—let me know if you don’t) we can chat about it. I’d enjoy it a lot.
    @Jennie Spotila

  5. When an advocate, doctor or patient is threatened because he or she has voiced an opinion we all are threatened, no matter what was the opinion.
    I was shocked when Eileen Holderman told the committee that she was intimidated because of her viewpoint. It was confirmed that two other members of the committee had been also threatened. Perhaps even more shocking was the fact that the committee merely raised an eyebrow, or perhaps this was too much of physical expression. The committee did not even discuss or debate this matter.
    When Dr. Wessley was threatened in Britain the police were called in. Any intimidation is not acceptable, the committee action must address this problem promptly.

  6. Amy S says:

    Excellent summary, Jennie. Thank you for your service to the community–I know it comes at a heavy price.

  7. Jill says:

    ME/CFS is not a diagnosis. All ME/CFS groups and proponents constantly mix and misuse terms and meanings. CDC is researching CFS. Again, CDC research uses Fukuda, which is a CFS definition. It is not for ME or ME/CFS. This is patients false illness beliefs. ME patents are stakeholders as well and do not want to be mixed in with or as CFS. Scientifically ME/CFS is gibberish. We do not know what anyone is talking about. This is the real issue with this committee. This is a CFS committee. Nothing gives them the right to hijack ME or make up ME/CFS. This was never discussed or even mentioned publicly. It was just done. This is what FACA should be concerned about. Or lawyers.

  8. Mary Dimmock says:

    Jennie and Toni,

    This article by Christley has a simple table and descriptions for key “CFS” definitions that is useful –

  9. Mary Dimmock says:

    This is a very good summary and does a great job of highlighting some of the key issues we are facing. Thank you for doing this

  10. floydguy says:


    I agree. We should not allow this to be pushed under the rug. In addition, there was so much wasted time and effort over the 2 days and when this other and issues of substance came up they were ignored or moved along due to “time considerations”.

  11. Janelle Wiley says:

    Thanks for this info, Jennie. I totally agree about the TOO SLOW problem. I think the root of it is Not Invented Here syndrome. We should object to this. We do not have time for them to re-invent the wheel just so they can be the primary author. There is nothing wrong with refining case definitions with the most current knowledge, but for goodness’ sake use something decent and specific and EXTANT now please! They have some options. It should take no more than 1 week to pick one, 1 week for *rush status* preliminary website edits on all HHS sites. Maybe more to continue revising websites, but 2 weeks to first rollout. Let’s do this. #MEdefNOW #by21June2013

  12. Jill says:

    There were serious allegations about this committee that were made publicly. The CFIDS Association has ignored it and all that these so called patient groups do about it is send thank you notes. It is no wonder. Want an ME def? Go to HHS, not a CFS committee.

  13. Deborah Waroff says:

    I would suggest that the two day tests have been ruled out because they would be really, really, informative.
    Government did not move nearly this slow when it came time to wage war.

  14. Michelle says:

    There was so much I’ve read about this CFSAC meeting that was concerning that it’s hard to know where to start. But I want to pick up on an issue in this post about the 2-day CPET — or lack thereof — in the current CDC multi-center study. As I’ve actually been rather optimistic about it, hearing that this very crucial test will not be included is very disappointing and merits, I think, greater discussion in ME/CFS community. While I’m not totally surprised to hear that Dr Klimas said it was “inadvisable” given that it appears she and Sol use a one day (5 minute?) submaximal test rather than the Stevens Protocol, and I certainly do appreciate the enormous burden it would place on these heroic patients who are already submitting to a battery of tests. However, I’m left to wonder what sort of “stressing” of the patients are they doing? Are they doing even the Sol submaximal test? What is so very clear every since Snell et. al. came out with their initial finding a decade ago is that you must stress the patient to find abnormalities. Moreover, we need very clear, hard data for this potential definition-to-end-all-definitions — especially with regard to exercise.

    I know from you’re last post that you’ve got a lot on the tiny plate this Damn Disease gives us, so I understand if you can’t respond to to my comment. Your reporting of this — and all the other many other very important issues — has been a tremendous contribution. Thanks for letting us know what’s up!

    • Jennie Spotila says:

      I agree 100%, Michelle! I am bewildered by this. But many advocates share our view and are trying to figure out what to do about it.

  15. Pingback: “Intimidated, Frightened, Threatened with Eviction” – CFSAC Spring 2013, Day Two

  16. Michelle says:

    After this discussion with Simon over at Cort’s blog with regard to two-day CPET, I’m a little more agnostic about it. Granted, I haven’t slogged through Christopher Snell’s presentation at the FDA meeting (yet, that is), so I’m taking Simon’s word for the larger, more conflicting results. As nothing has been published yet and what is published is so small, it’s hard to know what to think about two-day CPET.

    • Jennie Spotila says:

      Michele, the hyperlinked text does not have a URL. Can you post the link again so I can find the discussion you’re talking about?

  17. Michelle says:

    So sorry about that. My issues with sequential tasking showing. Hopefully thisworks. My reply to Simon’s comment directly follows.

  18. Mark Peterson says:

    Hi Jennie,

    Thanks for the effort and hard work that went into this report! Hope all of this is not a negative for your health. Many things about this are concerning. The three members who were threatened is a bright red flag to me. Is this common? Will we learn more about this as time goes on? What person or agency was doing the threatening ? Thanks again and keep up the great work!

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