Another CFSAC Done Gone

The CFS Advisory Committee held its second meeting of the year on October 3-4, 2012. Last time, I organized my summary around the good, the bad, and the WTF moments. This time, I am organizing around the discussion themes. Overall, I felt this meeting was more substantive than in the past. There were even hints of introspection and data driven discussion.

Agency Updates

Assistant Secretary Dr. Howard Koh attended the opening of the meeting, and provided an update on the Department’s efforts since the last meeting. I was watching the meeting via webcast, and my feed froze during Dr. Koh’s comments. However, the portion I did see contained nothing new. Dr. Koh did not provide any details on the Ad Hoc Working Group beyond what we already know. Unlike previous meetings, he did not take questions from the members. Although he said “the committee has gotten stronger,” he did not announce the appointment of a new member to replace Dr. Rose. The committee bylaws require vacancies to be filled within 90 days, so the failure to appoint a replacement is a violation of the bylaws.

Both the FDA and Social Security Administration gave substantive presentations to the Committee. In my opinion, this was the high point of the meeting. Both Dr. Sandra Kweder (FDA) and Arthur Spencer (SSA) provided detailed information about their agencies and CFS related data. Dr. Kweder reported on the status of nine investigative new drug applications for CFS. Mr. Spencer provided disability data that the committee has been requesting for years. The overall approval rate for Social Security disability among cases where CFS is the primary diagnosis is 21%, in contrast to a national overall rate of 30%. I’m looking forward to seeing the slides from both these presentations because there was a lot of good information in them.

NIH and CDC also gave detailed updates. Dr. Susan Maier (NIH) reported that several new members were added to the Trans-NIH ME/CFS Working Group, including Dr. Harvey Alter. It’s very good news that Dr. Alter is staying involved in CFS despite the end of XMRV. Dr. Maier also provided (for the first time) data on the acceptance rates for CFS-related grant applications. The overall success rate is 25%, and in FY2012 the success rate is 18%. These rates are higher than the overall rate across NIH. Most of CDC’s report was focused on various education initiatives including CMEs offered through Medscape and CDC, as well as video of patient vignettes for the MedEd Portal that will be finished next year.

That ToolKit

CDC announced that after extensive debate, they have decided not to remove the ToolKit from the CDC’s website. Dr. Beth Unger said that they believe it should be available until it can be updated to reflect the other website revisions. Surprisingly there was little fanfare or reaction to this announcement. At its June meeting, the CFSAC had recommended that the ToolKit be removed. Dozens of patients testified in June and at this meeting that the ToolKit is harmful misinformation, and a coalition of groups and individuals submitted a detailed position paper to CDC in support of that June recommendation. Despite all that, the CDC has decided to keep the ToolKit. There was no pressure or reaction on the record from CFSAC members. No one asked why this decision was made, and no one besides Mr. Steve Krafchick pointed out that CDC is ignoring the CFSAC recommendation. CDC got off very lightly on this score, and I still can’t believe that no one raised a stink about it.

Chicken, Meet Egg

As I said above, Dr. Maier presented data on the approval rates for CFS applications to NIH. In light of that data, Dr. Gailen Marshall asked the committee why they thought NIH funding was so low. The high approval rate suggests that the problem is not NIH’s willingness to spend money but that there are few applications coming in. Dr. Mary Ann Fletcher spoke frankly about the perception in the research community that it is extremely difficult to get funding. She cited an unnamed researcher who left the field because of it, and pointed out that Dr. Nancy Klimas is quite successful in her applications for HIV and Gulf War Illness funding but not CFS. Eileen Holderman pointed out that the illness name, and particularly CDC’s definition and use of the name, dilutes our disease into simple chronic fatigue. This discussion tied in nicely with public comment by Matthew Lazell-Fairman and others that the decades of neglect and active denigration of the disease by CDC and other federal policy makers has created the climate where researchers believe they will not get funding. This circular discussion recurs at every single CFSAC meeting, but this time it led to the recommendation of creating a CFS study section at NIH.


Biomarkers in CFS was a recurring theme on both days of the meeting. Dr. Jordan Dimitrikoff gave a presentation on the challenges faced by those studying Chronic Pelvic Pain Syndrome to identify biomarkers, not just for diagnosis but also to generate hypotheses about potential treatments. This is very similar to the approach of several CFIDS Association grants, in which a symptom or biomarker is queried to identify a possible drug to address that symptom or marker. Dr. Dimitrikoff acknowledged that the “true experts are the patients,” and he advocated setting aside cognitive bias to evaluate data and create learning networks. Dr. Fletcher then presented data from her research with Dr. Klimas and Dr. Gordon Broderick which identified different gene expression profile networks in CFS and Gulf War Illness patients, especially in immune pathways. This presentation complemented Dr. Dimitrikoff’s nicely, giving very specific examples of how biomarkers could lead to identifying potential drug treatments.

Discussion covered several very important points. First, that the case definitions are producing too much variability among patients. Without animal models, it is very difficult to study patients in a meaningful way without narrowing down the clinical presentation. Second, biomarkers must be distinctive in order to be useful. It is not enough to distinguish healthy controls from CFS patients. Biomarkers must distinguish between CFS and other chronic inflammatory conditions. In other words, if a biomarker cannot distinguish CFS from rheumatoid arthritis or lupus then it is of less utility than one that can. This has implications for both diagnosis and treatment trials.

Dr. Kweder’s presentation on the FDA and CFS treatment trials focused on the importance of outcome measures in order to quantify whether a treatment is having an effect. Outcome measures are not necessarily biomarkers; for example, there is no biomarker for migraines. But the more objective and quantifiable an outcome measure is, the more useful it is in clinical trials. Dr. Kweder pointed out that CFS has no single accepted case definition, no quantifiable way to measure symptoms and no biomarker for disease presence or activity. These are barriers to clinical trials, and partially to blame for the lack of trials in CFS. Dr. Kweder cited fibromyalgia, irritable bowel syndrome and depression as examples of conditions that received more clinical trials when those barriers were addressed. The FDA stakeholders’ meeting in spring 2013 will focus on identifying valid reliable outcome measures for CFS clinical trials.

There is a significant difference of opinion about whether we already have biomarkers and outcome measures for CFS. Dr. Fletcher and others cited a variety of measures already in use by researchers and clinicians. Dr. Fletcher was adamant that biomarkers did not need to be exclusive to CFS in order to be useful. Dr. Kweder said that a quantifiable biomarker or outcome measure must correlate to how the patient feels or fares. She also noted that heterogeneous conditions need larger clinical trials, so identifying subgroups can help target a treatment to those it is most like to help.

Case Definition

This is such a controversial topic, perhaps I should not expect a discussion of it to go smoothly, but the committee struggled once again to chart a way forward. Dr. Nancy Lee said that the case definition issue was discussed in at least one meeting with Secretary Sebelius, and that the Secretary was clear that the case definition must come from the medical community. Dr. Lee said that a recommendation from the committee that the Secretary endorse or adopt a specific definition will go nowhere. Dr. Marshall tried to focus discussion on designing a process that would produce a definition, but the committee quickly got snarled in the complexity of the problem.

One of the most contentious issues was whether the medical community has already endorsed a definition. Mr. Krafchick pointed out that the IACFS/ME used the 2003 Canadian Consensus Criteria in writing the Primer, and that it was the body of experts in this condition. Dr. Lee argued that the entirety of the medical community needed to endorse a definition, and Dr. Fletcher countered that this was not only unrealistic but was not a standard applied to any other illness. The root of this disagreement is the status of the IACFS/ME versus other medical societies. When the American College of Rheumatology endorsed a definition of fibromyalgia, the rest of the medical community accepted it because the ACR is a defined sub-specialty of medicine. Dr. Marshall drew a sharp distinction with the IACFS/ME, which is not a sub-specialty that offers board certification, and insisted that the American Colleges must have input into the definition in order for it to be widely accepted. This led to another vigorous argument over whether ME/CFS experts should address the definition or if non-experts should be invited to provide input and endorsement. The committee split over this, and in the end voted 5-4 (with one abstention) in favor of limiting input to the ME/CFS experts at this stage.

The other thorny question was whether to start with one of the existing definitions (Fukuda v. Canadian Consensus 2003 v. International Consensus 2011 – and different members referred to these papers by different names which made it even more confusing) or start from scratch. Dr. Dimitrikoff and Dr. Dane Cook recommended learning from definition processes in other illnesses such as lupus or IBS. Dr. Ermias Belay and Dr. Unger from CDC both advocated for a data driven process, relying on their multisite study that should be completed next year (although they did not promise a finished paper next year). This led to frustration among Dr. Fletcher, Mr. Krafchick and others about delay and the need for immediate action and leadership. After much wrangling, the committee settled on the 2003 Canadian Consensus Criteria as the starting point for a process to produce a clinical definition (see text of recommendation below).

One thing that got lost in this discussion was the role of patients. My impression from the preliminary discussion on October 3rd was that Dr. Marshall and others recognized patients as important stakeholders in this process. But the role of patients was not discussed on October 4th,  and the final text of the recommendation did not specifically include or exclude us. I don’t think it is an exaggeration to say that there will be hell to pay if patients are excluded from the process of creating a new case definition.

Committee Effectiveness

At the end of the first day, Dr. Marshall invited committee discussion on recommendations or other issues for the next day’s session. This led to a discussion of how effective the Committee is in its work. Dr. Lisa Corbin and Mr. Krafchick expressed concern about the committee’s recommendations not receiving feedback or action. Dr. Lee stated that a response to the June recommendations is still in preparation, to which Mr. Krafchick noted that 111 days had passed since that meeting. It was also clear, once again, that members are not receiving materials related to the meetings. Dr. Krafchick had not seen Assistant Secretary Koh’s letter in response to the November 2011 meeting, and was told that “it’s on the website.” Does this mean that such key documents are not sent to members, or that they are not even notified when such information is posted to the website? Members were asked to read several articles in preparation for the case definition discussion the next day (again suggesting that they were not sent in advance), but the existing CFS case definitions were not among them. To be frank, I think it is appalling that more preparation is not done for these meetings and it clearly hampers the effectiveness of discussion. I also wish that members would give more thought to the phrasing of their recommendations in advance. The editing-by-committee process at the end of each meeting is frustrating to watch, and a little more care in proposing motions might help with that.

Final Recommendations

These are the recommendations to the extent I was able to capture the language. The final version may vary slightly:

  1. CFSAC recommends that the Secretary promptly (before 12/31/12 or as soon thereafter as possible) and in consultation with CFSAC members convene at least one stakeholders (ME/CFS experts) meeting to examine the Canadian Consensus case definition (Carruthers, 2003) and its utility for diagnosis and treatment of ME/CFS.
  2. CFSAC recommends that there be a standing committee for review of ME/CFS proposals at NIH.
  3. CFSAC recommends that NIH issue an RFA of $7 to 10 million to establish outcome measures, including but not limited to biomarker discovery and validation, in ME/CFS patients. (Note: This replaced a recommendation limited to just biomarker discovery and validation passed by the committee during the same discussion.)
  4. CFSAC recommends to the Secretary that she endorse the Coalition 4 ME/CFS option 1 proposal for the ICD10-CM that was recommended at the 9/19/12 NCHS public meeting. (Note: The committee passed this recommendation despite advice from Dr. Nancy Lee (DFO) that the Secretary would not intervene in the ICD10-CM process.)
  5. CFSAC recommends that the Secretary allocate specific funds to study cluster outbreaks of ME/CFS.
  6. CFSAC recommends that the Secretary allocate funds to study the epidemiology of patients with severe ME/CFS.
  7. The members also voted unanimously to send a thank you letter to President Obama.
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16 Responses to Another CFSAC Done Gone

  1. Jean Harrison says:

    Thank you for the excellent summary of the meeting! Evidence based medicine is only as good as the evidence upon which it is based so can be oh so very far from the mark. Wonder if they would ask Dr Lipkin about his criteria.



  2. Kim McCleary says:

    Thank you, Jennie, for the clear summary. This was the first federal meeting on a CFS-related topic that I have missed since 1992 and I was able to catch only short segments by webcast due to meetings scheduled long before the CFSAC dates were announced. Your summary will tide me over until the recordings are made available!

  3. Wilhelmina Jenkins says:

    Thank you for such a thorough summary and analysis, Jennie. Since I was unable to watch, you provide the next best thing!

  4. Justin Reilly says:

    Great summary and commentary! Thanks. I agree with you entirely.

  5. Janelle says:

    thank you for the summary 🙂

    I think on the general field experts versus ME/CFS experts, our own experts should create our own board-certified specialty in Neuro-Immune diseases, which would include Gulf War Illness, Lyme disease, and other currently neglected and overlapping diseases that our specialists often know about anyway. This won’t be simple, but I can’t think of a good reason why it shouldn’t be attempted.

  6. Gina Bettor says:

    Thank you for your wonderful assesment. I love the way you ask questions so important and provide very accurate answers! Thanks again, Gina

  7. Jill McLAughlin says:

    It is getting worse.

    It is not an ME/CFS committee (whatever that is). There is no definition nor recognized name change. Which ME/CFS is not. The purpose of a name change has always been to get rid of the trivializing, dreaded CFS, which this does not do. We do not need 2 names.

    The CCC ME/CFS definition was published a decade ago, in a journal that no longer exists, is rarely used. And this was not even an international consensus panel, it was published by Health Canada, so it is highly unlikely.

    They voted to use the IACFS/ME primer when the majority admitted that they hadn’t even read it.

    The Coalition 4 ME/CFS proposal to code CFS to ME was rejected last year. Nothing has changed. And Nancy Lee told them that HHS would not interfere, but they continue to waste time. But begs the question: why can’t they ponder, redefine, recode, rename CFS (since this committee in particular does not have the authority to involve or incorporate ME)?

    CDC has not been able to confirm a cluster since CFS was “invented,” so will not happen.

  8. Susan says:

    Fantastic summary and commentary for an extended, complicated and sometimes contentious meeting. Seriously: bravo!

  9. Jim says:

    Thankyou for the summary and analysis. It must’ve been immensely frustrating to watch these people in ‘in-action’. It’s probably a good thing I am not able to see video over my internet connection – I would’ve gone ballistic and triggered a major crash!

    It’s obvious the next Ice Age will arrive before this committee does anything useful. These people are grownups, right? They understand the concept of having a well-defined agenda, pre-meeting preparation, etc.? Or do they need to repeat Jr High?? Grrr….

  10. Heidi says:

    Hi Jennifer,
    I am a patient, and I have been wondering if there is a way I could write a letter to one or some of the SSA representatives who are attending CFSAC meetings. I have no idea how I should go about getting their contact information. I would be happy to send it through someone else if they don’t want to give out their personal info. The reason is that I feel as if I have been discriminated against in the last 7 years of attempting to get SSDI benefits, and I would like to ask them to help assure I get a fair hearing next time around, with a judge who is knowledgeable about these issues. I mean, what good is having SSA reps at CFSAC if they are not passing on the current research? The last two judges I saw heavily relied on “but you don’t look sick” and exploited the credibility loophole, disregarding everything that was self reported as a lie, and fully ignoring physical signs like low grade fever, swollen lymph nodes, and EBV antibodies, that are not fakeable. The judge gave little or no weight to at least 17 people’s input, including the head doctor at University of Washington’s CFS clinic where Dedra Buchwald is department head. (Dedra is one of the people who has done research on CFS the longest. As much as I disagree with some of her views, she could be considered an “expert.”) The last judge said the association between my heart problems and ME/CFS is “hearsay” even though the cardiologist wrote in my record that they are probably related. Applicants are not allowed to submit any information, such as the IACFSME Primer or any other supporting research. We are just supposed to assume that the judge knows about these things and is not biased. It is a crock, imho. The judge accused me (without supporting evidence) of abusing pain meds, when ironically, I cannot afford any alternative pain therapies out of pocket, until I have a regular income from SSDI. She said my 8 years of claiming to be sick has been an elaborate plan to seek and find pain meds, that I gave up my entire life at 25 to pull a con on the system. I didn’t even start on the pain meds until after a neck injury a couple years ago, which could be corrected with chiropractor care, if I only had SSDI benefits to pay for it!
    I don’t know if it will help my case in any way, but I feel like I need to let those representatives know what is happening to patients like me. Everyone in my life, my doctors, counselor, lawyer, family, friends, are appalled and disgusted by what has happened to me, and appalled that their testimony has been disregarded.
    Please let me know if there is any way you can help, or anyone who reads this comment, please contact me at hystericalwoman AT gmail DOT com. Thanks.

  11. cfsboston says:

    There remains only two objective subsets of CFS:

    1) Gulf War Syndrome

    I do not include ME, because MEers do not have CFS.

    I did not speak at this meeting, because as Einstein was said: “insanity is doing the same thing over and over again, and expecting different results.”

    I spent my time writing to all the worldwide OCCUPY groups, GLBTQ Pride organizations, and the liberal progressive colleges.

    CFS & ME research will never make any real progress until we are marching/rolling in the streets (I.e., ACT-UP style).

    Thanks for the commentary. Great work, as always!

  12. Kelly Latta says:

    Thank you for this summary. I had meetings the second day and missed the discussion on case definitions.

    I do think that biomarkers can have levels of specificity. Even if a biomarker does not exclude other organic neuro-immune diseases if it excludes primary depression for example it may have utility. Eventually, one would hope, biomarkers will be found that delineate subsets within the existing definitions.

  13. Joe P. says:

    Thank you for the summary. It is much appreciated. I am a patient with CFS and have a question for you about the meeting. If you wouldn’t mind, could you e-mail me at Thanks–

    Joe P.

  14. Heidi says:

    @Jennie Spotila
    Thanks Jennie. I read your email. Anyone else who may know a way to contact those SSA representatives, please please help me get in touch at the email provided in my original comment. I take it very seriously that there is a lower approval rating for ME/CFS applicants than the average, so much that I am about to start gathering people for a class action lawsuit. I have met hundreds of others in my shoes along the way, and something has got to be done. I am housebound and often bedbound and the stress of having my SSDI claim hanging over my head for all these years has definitely made my health worse.

  15. Andrew says:

    I suppose the CDC considers ridiculous questionnaires and telephone surveys as data driven? Is it too much to hope this is not what they are producing?

    I agree that it was surprising that there was no debate over the CDC toolkit. I nearly fell out of my chair when no one remarked on this point when it was brought up.

    Thanks for your effort.

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