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.
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.