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CFSAC Takeaways

June 18th, 2012

I won’t attempt a comprehensive writeup of the recent CFS Advisory Committee meeting. This meeting was one of the most thoroughly covered: on Twitter (#CFSAC), real-time reports from Phoenix Rising, and a writeup by Tina Tidmore. Instead, I offer comments on what I took away from the meeting, good and bad.

Positives

  • Video! The live videocast was restored for this meeting, although Dr. Nancy Lee said that it was not clear how long the committee would retain the budgetary resources to provide this level of access. She also did not provide any figures on the number of people logged in, which Dr. Wanda Jones did at past meetings, so we have no way to know if video access increased remote participation in the meeting.
  • CDC – I was pleasantly surprised that CDC had some progress to report. The website has been partially revised as of May 16, 2012, and work will continue (which is good since many objections remain), including the addition of a section on pediatric ME/CFS. CDC has begun enrolling patients in a seven site clinical study in which expert clinicians will identify ME/CFS patients and collect mass amounts of data that CDC will analyze to identify key features of the illness. I wish there had been more discussion of the study design, especially since CFSAC members seemed confused about it. CDC also posted a new CME course on Medscape and 4,600 doctors have completed the course in about three months. Two additional modules are in development.
  • FDA – The FDA ex officio reported that there are eight active Investigational New Drug Applications currently in review. She could say no more than that, and commented that it had been extraordinarily difficult to get permission to say even that much.
  • Engagement – The ex officio members were more engaged in the discussions than they were a few years. They tried to help the committee understand what is possible (or not) on issues like the IACFS/ME Primer, and also offered perspective on discussions like how to pursue revising the case definition. Engagement by and information from the ex officios is a good thing, and I hope the committee will rely on them as a resource.
  • Best Line of the Meeting – In my opinion, the best statement of the meeting was made by Matthew Lopez-Majano during the panel discussion with two adolescent patients and a parent. A CFSAC member asked the panel what they felt was most important for new doctors to know about the illness. Matthew responded, “Have an open mind. There is no diagnostic test for this. You only have our word.” Love that!

Disappointing

  • NIH – Dr. Susan Maier reported that FY2011 expenditures on ME/CFS at NIH totaled $6.3 million, although she did not provide a full list of those grants or even the general categories of the studies. She also reported that the Trans-NIH ME/CFS Working Group took the priorities identified in the State of the Knowledge Meeting and turned it into a list of actionable items. Why did it take 14 months just to develop a list of action items? It was disappointing that no member of the CFSAC asked that question on the record.
  • IACFS/ME Primer – There was a great deal of discussion about the new IACFS/ME Primer for Clinical Practioners, with Dr. Gailen Marshall and Steve Krafchick pushing for endorsement and distribution of the Primer by DHHS. But it was clear from the outset of the discussion that multiple members of the Committee had not read the Primer at all, even on the second day of the meeting. The discussion was circular, and frustrating to watch. Several ex officios tried to offer input on what DHHS could and could not do with the Primer. Overall, this was a disappointing discussion that would have been easily improved if members had been briefed in advance and if the IACFS/ME had been able to participate. A final recommendation was made, “That the Secretary should authorize the appropriate person within HHS to work with IACFS/ME to make the primer widely available, particularly to primary care providers.” I fear this may be so nonspecific as to be useless. It might have been better for Mr. Krafchick to withdraw his motion until IACFS/ME could participate in the discussion.
  • Case Definition – The case definitions of ME/CFS have long plagued researchers, clinicians, and patients. Dr. Lee attempted to facilitate a strategic planning discussion for the committee to come up with a plan of action to arrive at a new consensus definition. This is another topic that would have benefited greatly from advance preparation by the members. I’ve run strategic planning discussions and they are HARD, but if everyone at the table does not have the same grasp of even the most basic issues, the discussion is rarely productive. For example, one of the new members asked what were the problems with the current definition. I don’t fault her for asking, but this is a fundamental issue that was planned for the agenda! How could the committee staff failed to have brief members in advance? I applaud the committee for attempting it, but they flailed around for an hour and the only action item identified was for the conversation to continue and Dr. Lee may make assignments to subcommittees.  Another sign of the extremely poor preparation was that the committee already made a recommendation on this issue in October 2009 but not one person mentioned this during the discussion. Did anyone bother to look? Recommendation: Multiple case definitions currently are used for CFS. The CFSAC rejects the empirical case definition and the terminology of “chronic un-wellness”, both of which are endorsed by the CDC, and recommends that DHHS recognize a need for and commit to support a national effort to arrive at a consensus definition of CFS that is accurate, standardized, and reflective of the true disease. Response: Yes; The CDC uses the 1994 International Research Case definition. The term “chronic unwellness” is not a CFS case definition component and is not used as such by the CDC. I might also note that this is another example of the kind of non-responses I highlighted in my own testimony.
  • Recommendations – In addition to the recommendation on the Primer, the committee passed three other recommendations. Two of them related to links to be placed on the CFSAC website, and the discussion around those dragged on for at least 20 minutes while voting members were leaving and the quorum was dropping away. The last was a recommendation that HHS partner with CFSAC and the Dept of Education to educate educators and school nurses on ME/CFS affecting children and adolescents. This was the ONLY recommendation on pediatric issues, despite the fact that most of the first day’s session was spent on pediatric ME/CFS.

What the . . . ?

  • Preparation – As I mentioned above, there were several times in the meeting where it was clear that some members were inadequately prepared for the discussion. Mr. Krafchick and Marti Bond (Office on Women’s Health) had an exchange regarding the materials provided to committee members. Marti Bond said the agenda was emailed to members two weeks prior to the meeting, but that the materials binder was provided upon arrival. In the past, apparently, they have mailed the materials to members who then failed to bring the binders to the meeting. This required running additional copies of the materials. *sigh* Adequate advance preparation is essential if these meetings are to be productive. Why not email the key documents (like the Primer, a memo explaining case definition issues, and the Recommendations Progress Chart) to members in advance and provide the full hard copy binder upon their arrival?
  • Feedback – At the November 2011 meeting, the committee asked the Secretary to clarify the process of transmitting recommendations and receiving feedback. Dr. Lee stated that the ex officios had collaborated on a white paper describing the process and capturing feedback from the Secretary. She stated that the memo is in clearance and she hoped to provide it to the committee very soon. Unfortunately, she made this announcement at 4:50pm on the second day. It would have been really nice to know this information at the beginning of the meeting. I would have edited my own comments to incorporate that information.
  • Commitment – After the lunch break on the second day, Dr. Lee made remarks about the commitment of everyone at the table. Phoenix Rising captured the comments (not sure if this is verbatim quote): “I want everyone to know we are committed to this topic. Some people have worked for many years. We have several of our government members personally affected by ME. We are very committed to this, or we wouldn’t be here.” What precipitated these comments? Was it the public comment session that preceded the lunch break? My comments were critical of the committee and HHS, but I did not question anyone’s personal commitment. Matthew Fairman made a comment about public officials passing the buck and that there has been a violation of the public trust. But comments like these have been made before at other meetings. Dr. Lee’s comments sounded defensive, but I don’t know if she was speaking for herself or for other members who had concerns. The whole episode was quite puzzling to me.
  • Dr. Koh – Assistant Secretary Dr. Howard Koh attends a small portion (~30 minutes) of each CFSAC meeting (unlike his predecessors who usually did not attend at all). In introducing Dr. Koh, Dr. Gailen Marshall said, “There is no stronger advocate for people with this illness.” Uh, what?? Given the other people at the table, in the room, on the phone, Dr. Koh is the strongest advocate? Is that in some secret behind the scenes way that is completely invisible to the public? I know I would very much appreciate hearing what Dr. Koh is doing to advocate for me and all the other patients. But what killed me about Dr. Koh’s brief appearance at the meeting is that when he opened the floor to questions from the committee members, NO ONE SAID ANYTHING. Seriously? The Assistant Secretary just invited questions and YOU DON’T HAVE ONE? I can think of five questions just off the top of my head. 1) Dr. Koh, will you commit to changing the name to ME/CFS? 2) Dr. Koh, how many briefings on ME/CFS have you had with the Secretary, when and for how long? 3) Dr. Koh, may we have your personal assurance that you will respond to each of the committee’s 65 recommendations prior to our next meeting? 4) Dr. Koh, what have the Secretary and Dr. Francis Collins discussed regarding the level of NIH funding for ME/CFS research? 5) Dr. Koh, when will you meet with us in person to discuss each of our recommendations? I just could not believe that everyone let that opportunity slip right on by. Maybe members should keep an index card with a question on it in case they get another chance with Dr. Koh.

Overall, I think this meeting was no better and no worse than every other CFSAC meeting I have observed. The ME/CFS advocacy community must continue to build on the foundation we have, and do everything possible to secure accountability from both the committee and DHHS. I’ll be posting more articles about the CFSAC in the coming months, and I hope this will help the community coordinate its information and approach to the committee.

 

 

 

  1. June 18th, 2012 at 12:59 | #1

    Regarding a previous CFSAC recommendation you highlight:
    ——
    Recommendation: Multiple case definitions currently are used for CFS. The CFSAC rejects the empirical case definition and the terminology of “chronic un-wellness”, both of which are endorsed by the CDC, and recommends that DHHS recognize a need for and commit to support a national effort to arrive at a consensus definition of CFS that is accurate, standardized, and reflective of the true disease.
    Response: Yes; The CDC uses the 1994 International Research Case definition. The term “chronic unwellness” is not a CFS case definition component and is not used as such by the CDC.
    ——
    This is a very good example of a misleading point in the list of recommendations and whether they have been acted on.

    The recommendation hasn’t been dealt with in the way it says. The CFSAC recommended the CDC not use the empirical case definition. The CDC has continued to use it. The CDC has always said it uses the 1994 International Research Case definition (it has always said the empirical case definition was a way of doing it). So nothing changed and the response gives the impression the recommendation was misinformed. But it wasn’t: it was very specific. Such wording in a response shouldn’t be accepted by the CFSAC.

    • Jennie Spotila
      June 18th, 2012 at 13:17 | #2

      I COMPLETELY AGREE, TOM! The Recommendations Progress Chart is full of non-responsive responses, and the CFSAC has never challenged DHHS on this publicly. This is why I chose to focus on it for my testimony, and I want to do a more complete writeup on all the examples.

      I think the committee could do a better job of writing their recommendations to eliminate some of that wiggle room. But it is also clear that DHHS could be more responsive if they chose. At a minimum, the CFSAC has to publicly challenge these kinds of responses or we have to do it for them.

  2. June 18th, 2012 at 13:22 | #3

    Jennie,

    I just wanted to thank you for this informative article (as well as your previous post on your testimony). Thank you for keeping us informed and for the advocacy that you do. I’m so grateful to you.

    • Jennie Spotila
      June 18th, 2012 at 13:39 | #4

      Thank you, Toni! That means a lot to me!

  3. Anne Ö
    June 18th, 2012 at 13:34 | #5

    Thank you so much for this, Jennifer.

    I felt just like you regarding preparation: I nearly fainted when a committee member asked “so what is the problem with the current case definitions..?”

  4. Sasha
    June 18th, 2012 at 15:42 | #6

    Thanks for this summary of your thoughts, Jennie – it captures everything – the confusion, the weirdness, the positives. I’m glad you’re involved in keeping an eye on CFSAC.

    • Jennie Spotila
      June 19th, 2012 at 09:19 | #7

      Weirdness is a really good adjective for some of that meeting!

  5. Tina
    June 23rd, 2012 at 11:42 | #8

    Jennie, good to see your review. I agree with all of it. I particularly appreciate your noticing the vagueness of the recommendation on the primer. I thought the same thing. You’ll remember he tried to make it specific, but got reasons why it wouldn’t work. If an IACFS/ME member was there, some of those issues could have been resolved. While not specific, at least it gets the issue on the radar and maybe they will all be prepared in Nov. with clarification from IACFS/ME and they can do something more specific in Nov.

    The only thing I will add is that the discussion on how to create a new definition was a total waste because the CDC is already coming up with another one. Yes, it will take two years. But in ME/CFS history, two years is not that long. And they are working with the 7 experienced experts. If the CDC listens to them, then it will be good. And, they will want the support of the experts to stop all the complaints. So, why do we need a separate effort to do the same thing? While getting buy-in of professional orgs would help, the CDC carries enough credibility and influence that their new one will be accepted. Just look at how widely used the Fukuda is, even though it is a research definition and not a clinical definition. I would have preferred they make a recommendation that the CDC take their 7 expert effort to broaden into making two, one for research and one for clinical use.

    Jennie, if you haven’t seen my nightly summary, go to Marly’s blog at One Agent for Change.

  6. DC
    June 28th, 2012 at 17:21 | #9

    Jennie, Thanks for summarizing the meeting!

    I’m glad you are keeping track of what is has been promised/ recommended and what actions have been taken. It’s the best way to keep government accountable. It was disappointing to me too that some members were not familiar with the issues but my understanding is that the fault lies more with the government perhaps than individual official members. My feeling is gov’t staff like to give the impression that things are being done but just like the old saying, “Actions speak louder than words,” late distribution of materials, only informing people 2 weeks before the meeting when it is (and delaying it by a month this time, meeting usually in May), putting the agenda out later, giving the public a short time to submit testimony, and not allowing orgs to phone in all speaks to sabotaging the process rather than trying to really move things forward. Sure, all types of excuses are given and rules are invoked, but if they truly wanted to solve CFS, they could do better.

    I am by no means a basher of all government. My parents worked for the feds prior to retirement. In the state I live in, some state gov’t offices in fact are very efficient and surprisingly customer-oriented. But not the administration running CFSAC.

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