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:

• The HHS officially announced that the Institute of Medicine (IOM) would immediately begin a study on developing Diagnostic Criteria for ME/CFS, in response to a 2012 CFSAC (CFS Advisory Committee) recommendation and that the process will include stakeholder input, including patients and practicing clinicians. You can read the rest of the details about the process at the link above.
• A group of 35 of the top U.S. clinicians and researchers in ME/CFS sent a letter to HHS Secretary Sebelius, asking her to stop the IOM process and announcing that they had come to agreement on a single clinical case definition that's already been developed, the Canadian Consensus Criteria (CCC). This is huge and unprecedented! The 35 signatories include many of our most respected ME/CFS experts - names that you have probably heard over and over again through the years, including Dr. David Bell, Dr. Leonard Jason, Dr. Daniel Peterson, Dr. Nancy Klimas, and many more. Patients gave a collective cheer! For this group of highly regarded experts to come together and announce their solidarity behind a single case definition is a huge step forward. You can read their letter here and further discussion and explanation here.

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!