Thursday, October 03, 2013

ME/CFS Case Definition - News and Views

There have been some startling and ground-breaking developments in the ME/CFS world in the past few weeks. I have postponed writing about them because I wanted to have the mental energy to consider all sides of the issues and to think it through myself. Things have been hectic here at my house, and I've had two rough weeks CFS-wise (probably because of my son's cold and sinus infection). I didn't want to delay getting this news out to you any longer.

So, here is a brief recap of the events of the past week or two. I have tried to keep things simple here, but you can click any of the links for more detailed information:

1. At the end of August, the US Department of Health & Human Services (HHS) announced that they planned to start a process to develop a clinical case definition of ME/CFS (i.e. a definition of the illness that doctors can use to diagnose patients). Now, this is clearly something that is desperately needed for ME/CFS patients; however, the proposal also named a single contractor, Institute of Medicine (IOM), to develop the criteria. This rang some alarm bells in the ME/CFS patient community because IOM has been working on a similar definition for Gulf War Illness (a chronic illness that has a lot in common with ME/CFS). There have been some concerns raised about this IOM process with Gulf War Illness, as described in the article linked to above.

2. That HHS announcement set off a complex chain reaction with the community of ME/CFS patients, doctors, and experts. Many people, fearing that IOM would approach this project without involvement from bona fide ME/CFS experts and patient input, participated in a letter-writing campaign to HHS to stop the IOM initiative. Apparently, all of the letters had some effect because two major things happened on the same day in late September:
3. As you can imagine, both of those announcements caused a lot of uproar, and individuals and organizations alike scrambled to consider all of the facts and decide what their position would be. Stand behind the 35 experts and the CCC? Support the HHS and the IOM process and trust that they will do what they say and include real experts and patients? Somewhere in between? Some of the 35 experts who signed the letter stand by it 100% and don't want the IOM process to move forward. Others feel cautiously optimistic that the IOM will conduct the process as stated, with stakeholder input, and that it might be beneficial, especially if the CCC is used as a starting point.

4. Through the Freedom of Information Act (and thanks to Jennie of the Occupy CFS blog), details of the IOM's statement of work (SOW) have been published and disseminated. You can read the details in this blog post that Jennie wrote. It does appear that IOM is saying all the right things with respect to stakeholder involvement and a solid process that uses existing data, criteria, and information.

5. Meanwhile, in social media and through e-mail, comments, opinions, and a fair amount of vitriol have been flying back and forth among patients. Most don't trust the government (with good reason based on past problems), many are applauding the 35 experts, some are attacking experts whose names didn't appear on the list. Unfortunately, emotions are running high and not all of the discourse is respectful and constructive; many people are being reminded of the rifts that occurred in our patient community during and after the XMRV research a few years ago.

6. After carefully considering all the facts and input from patients and their own Board, the CFIDS Association of America just announced its position on the HHS/IOM contract to develop diagnostic criteria for ME/CFS. Their statement provides a nice, concise summary of the facts, so it is helpful to read from that perspective. They are basically saying that they want to support this process as it moves forward, using their expertise and resources in the best way possible. They say that the CCC is a great starting point, that the IOM process could have value if it is done as laid out now, and that the IOM needs to be held to its commitments, with swift action taken if they fall short of their promises (to include patient input, to include ME/CFS experts, to use existing criteria, studies, and research as a starting point, etc.).

As for me, I am mostly in agreement with the CAA's statement. Some in the patient community no longer trust CAA because they feel that by working directly and closely with the government (CDC, NIH, HHS) the Association has turned its back on patients. I have a different view. I think that realistically, nothing major is going to happen for our illness unless the government agencies who control all aspects of health management (research, treatments, doctors, etc.) are on board. I feel that the best way to move forward into a better future - one that includes clear diagnostic criteria and effective treatments - is to work together with these agencies, in a cooperative and respectful way.

From a more personal perspective, I try to stay away from all of the anger, bitterness, and vitriol that crop up during controversies like this. Those kinds of negative emotions just make me sicker - often far sicker than even physical exertion - and I simply can't afford that. Of course, I am angry over past mistakes the government has made and its past ignorance of ME/CFS and lack of support. But I can't let that anger get the best of me and make me even sicker. That's in the past. More recently, there have been positive signs: CFSAC meetings incorporating more patient interaction and input, FDA workshops held to gather patient input, and even this very initiative. I honestly believe that most people involved with these processes - on all sides - believe they are doing the right thing. Though we have seen single cases in the past where an individual was doing something wrong and knew it (for instance, the infamous misappropriations of funds by the CDC), those are the exceptions. I firmly believe that taking sides and turning this into an emotional battle will not benefit anyone.

Look at all of this from the positive side - the HHS finally wants to develop a real clinical case definition for ME/CFS (and they are even calling it ME/CFS!). Wow. That is something we have desperately needed for decades. Indulge for a moment in a dream of how things could change over the next few years: there could be a single, agreed-upon definition - developed by patients and experts - that all medical personnel have access to and are educated about. Wow!

Yes, there are lots of potential problems along the way, plenty of challenges to face, and a lot of hard work to do, but let's take a moment to celebrate this momentous occasion and get ready to move forward!


  1. Sue, you have such a talent for collecting, collating and disseminating complex information in a clear and objective way. Thank you for all the hard work this post must have taken. Great work x

    1. Thank you, dear Cusp, for your kind words and especially for acknowledging the effort/energy required. Having a tough week and very much appreciated to be appreciated :)

  2. Thanks for writing this succinct overview. I will say that reading IOM's Statement of Work they haven't said the Canadian criteria would be the starting point ( which would be great) but that they will look at various criteria, including my country's seriously flawed NICE guidelines.

    They have said they will include practising clinicians, I am just fearful who and how many, a token one or two?

    I do think IOM's awful work on Gulf War disease is a great cause for concern. I am worried

    1. Prue -

      I share your fears, as do most patients. We have certainly been mistreated in the past. But there is no doubt that progress has been made in recent years, and I am hopeful that it will continue. With those 35 signatories of the letter - all top experts in ME/CFS - the IOM can't possibly ignore or marginalize the real experts...I hope!

      As for the SOW including CCC as a starting point, remember that the letter signed by the 35 experts came out on the same day as the announcement to appoint IOM so there wasn't a chance for them to consider the letter yet - hopefully, it will be considered as they move forward.

      I share your concerns but also remain hopeful!


    2. Thanks for your reply. I only saw it today. I really hope I am wrong on this issue but I think we could be being played and we could end up with a worse case definition than Fukuda. All the very best. Sorry to hear you are in crash this week :-( Hope you improve soon


  3. Further to yesterday's comment regarding IOM statement of work saying they will include practising clinicians someone today wisely pointed out that the group that came up with the Fukuda cfs included some excellent me/cfs clinicians but their input was outmanoeuvred by the psychs on board and the CDC. I remain concerned...

    1. Jill McLaughlin6:54 AM

      ME/CFS is a scam no matter who promotes it. There is no disease ME/CFS, it is just made up. This is just to make up an illness called ME/CFS. ME does not require CFS. All of these people/groups work against ME patients.

    2. Jill -
      I think all patients would agree that the name CFS is misleading and should be removed completely. I don't think anyone wants ME/CFS as a permanent name - we would all be quite happy to drop the CFS part all together. Unfortunately, the CDC doesn't see it that way - yet. It is a big achievement just to see them add ME to the name - for now. The goal is to do away with the CFS moniker completely. Unfortunately, though ME is a common term in the UK, it is almost completely unknown here in the US so far.

      Also note that the 35 experts and the Statement of Work both mention sub-categories of the illness - surely, one of those would be for the most severely disabled who clearly have classic ME.


    3. Thanks, Sue, for keeping me up to date. I am a member of the CAA but I wasn't aware of this progress. Must be lost in my emails somewhere. I agree with your assessment with their role with the government.

  4. Jill McLaughlin5:50 PM

    Sue, It is not just names. They are different diagnoses and identify different patients. Actually CDC does see it differently and does not use ME/CFS.

    Adding/combining ME with CFS is NOT an achievement (well except for the CFSers, who are mainly PR/politicians and love hijacking ME for the catchy slogans). ME will never be known if we continue to label or combine it as CFS or ME/CFS.

    The subgroup thing has been another red herring and distraction. They have bloviated for years about subgroups but never do anything to specify or require identification or recognition. Another scam to keep broadening and mixing, then it's oh we need subgroups.

    Severely disabled classic ME patients have remained in this CFS cesspool for far too long, that is the exact point, and will never get out of this ME/CFS quagmire, other than pronounce and educate that ME is NOT CFS. We cannot be a subgroup
    of a contrived misdiagnosis and expect anything to change.

  5. Thank you so much Sue because as a Naturopathic Doctor I don't even have the mental / emotional energy to deal with the politics and traditional medical community regarding CFS/ME after years of being dismissed, mismanaged, misdiagnosed and blatantly disregarded and I know I am not alone in this feeling so I also applaud you for doing this difficult work - that I right now have no energy for and am thankful for your efforts. Heather