Here is the statement presented to the IOM committee on “ME/CFS” on January 27, 2014, by advocate Anne Keith. Many thanks to Anne for making the effort to travel to the meeting and to present this talk there.
[Anne placed four containers of water, a fifth empty container, and three different food coloring dyes on table. A small vase with flowers was left in the back of the room since she couldn’t carry it all up front.]
I’m an ex-school teacher so I brought some visual aids.
The basis of medicine is “primum non nocere”: “First, do no harm.” It is the underlying principle of all medicine. It is drilled into medical students for a very good reason. Medicine, beyond any other field, has the greatest potential to do good and harm.
Harm is not necessarily determined by intent, effort, or education. “Primum non nocere” is a reminder that it is important to evaluate and mitigate both potential obvious and hidden harms. It takes insight and courage to speak up and say that something is should be done differently or not done at all.
This simple demonstration will show you why HHS’s request to consider using multiple definitions to come up with a new definition puts you in the position of needing to have that insight and courage.
A perfect definition is like water. It’s clear and it’s unadulterated by anything.
[Anne held up a container of pure water.]
No definition of ME, CFS, or ME/CFS is perfect but there is a distinct progression of clarity.
CFSAC requested the refined definition be based on CCC for a very good reason. You have been asked, in your statement of work, to “consider the various existing definitions,” which is to say to combine these definitions, and the results of research based on them, to create a superior definition.
While that sounds laudable and even-handed, it is actually a political answer to a scientific question. No matter how great your skill and motivation is, it is simply impossible to merge divergent definitions, each with their own issues, into one superior one.
A definition may be clouded by many things. It is difficult to describe a disease that as complex as ME/CFS and so even the CCC has its faults.
Fukuda has the same faults and so does Oxford or other definitions you use.
[Anne added dye to third and fourth containers.]
Fukuda (I just looked at the main definitions) is general in its description of the symptoms. They are vague. It describes PEM but it does not make it a mandatory item.
[Anne added a few drops of a different dye to container 3.]
Oxford really describes a depressive situation, as much as anything. Yes, it applies to CFS but it is also describing depression. It does not describe the distinct patterns that are often found by our researchers in this disease and it does not even mention PEM.
[Anne added a lot of the second dye to container 4.]
It is the definition that might as well just have everything in it.
[Anne added a lot of third dye to container 4.]
What HHS has asked you to do is to combine these definitions to come up with a different one. There’s no way that you can take this definition [Anne poured some of the now dark water of the “Fukuda” container into empty container] and this definition [Anne poured some of the now black water of the “Oxford” container to same new container] and come up with pure water [Anne held container of original container of clear water next to “mixed” container].
You can’t do it. You need to look at what is the actual disease.
The imperfections in these definitions cloud all the research that comes out of it. This morning I put some daisies into this dye [Anne indicated “Fukuda” and “Oxford” containers] and you can see that my white daisies [Anne pointed to the flowers] have turned green and orange in a matter of an hour or two.
It is the same way with research. These imperfections absolutely permeate the research that their based on.
So if you have research based on the Oxford definition, it is going to have those flaws inherent in it. They may be corrected for but you need, as a committee, to recognize that what you are reading, though it may sound reasonable, has flaws that you need to understand are there.
Combining these will not get a better definition, it will not clarify research. Research will only improve by starting with the best definition, using just the best research, and filtering the problems out. It is clear that the CCC is superior to other definitions and that it should be the basis of further refinement.
By serving on this committee, you have tacitly agreed to live by “do no harm.” A muddled definition will harm millions of patients for decades.
I ask you to choose to “do no harm” by refusing HHS’s long-standing patter of imprecise definitions. I ask you to report back to the HHS that they should immediately adopt CCC until such time as an expert-only committee can properly update it.