The prospect of the Institute of Medicine creating a consensus case definition for ME/CFS scares me. It’s not free-floating anxiety or IOM-hatred. We have a current example of what this IOM contract might mean for ME/CFS and it’s not pretty.
The IOM was recently contracted by the Veterans Administration to create a case definition for Gulf War Illness, which is now being called Chronic Multisystem Illness (about as nonspecific a name as you can get). That process is just getting underway, but it has already come under heavy criticism from GWI advocates.
The chairman of the case definition panel (and former president of the IOM) Dr. Kenneth Shine has said that he can’t recall the last time the IOM was charged with defining a disease. That’s because disease experts usually undertake such a task, not panels populated by non-experts.
In fact, the composition of the GWI panel has been strongly criticized by advocates. Of the sixteen panel members, only Dr. Suzanne Vernon is identified by GWI advocate Anthony Hardie as an expert in GWI research without a bias towards psychological explanations of the illness. The other panel members, including Dr. Fred Freidberg, either have no experience working with GWI or have previously expressed bias towards a psychological explanation. In addition, none appear to have expertise in developing case definitions for other conditions. Hardie writes:
The most striking characteristic of the group selected to be on this committee is how few qualify as experts in the disease. Case definitions are typically developed by committees of experts in the disease in question, using detailed data sources to ascertain objectively which elements best characterize the disease. . . . Assigning this vital task, which will influence all future Gulf War health research, to a committee largely without expertise in the illness, and directing them to carry out the task through a literature review, is without precedent.
If this is the kind of approach the IOM would take in ME/CFS – populating the panel with non-experts or those with a bias towards psychological explanations of the disease – it does not take much imagination to predict what sort of definition would emerge.
The scope of the IOM’s effort to define GWI also gives us some clues. The committee will define Complex Multisystem Illness “as it pertains to the 1990-91 Gulf War Veteran population.” The committee will review “the available scientific and medical literature regarding symptoms for CMI among the 1991 Gulf War Veterans.” They will also hold discussions with researchers and clinicians. You can see the full task list here, although I have been unable to find the actual Statement of Work for this contract. The work will include evaluating existing case definitions, identifying additional areas of research necessary to more adequately develop a case definition, and determining the appropriate terminology to apply to this patient population.
The panel has held two meetings (June and August). A half day public session was held in June, and comments were heard from five Gulf War veterans, four members of the Research Advisory Committee for GWI, and six doctors/researchers with GWI expertise. The remainder of both meetings were closed to the public, with brief summaries posted after the fact. The IOM effort to define GWI is scheduled to take a year, so we will not see the results of their work before May 2014.
In the meantime, HHS is rushing a sole source contract to IOM to create a consensus case definition for ME/CFS. What confidence can anyone have, based on the example of the GWI panel, that this IOM contract will produce a definition that matches the disease we described at the FDA public meeting on ME/CFS symptoms and treatments? If the IOM staffs the ME/CFS panel with non-experts and/or people who have a bias towards the psychological explanation for CFS, we’ll be in trouble. If the IOM does not spend significant time listening to the expert clinicians, researchers and the patients themselves, we’ll be in trouble. It’s hard to have confidence in this sort of process when we see regular jaw-dropping examples of ignorance from federal employees. For example, at the May CFSAC meeting, Dr. Beth Unger of CDC stated that she was not familiar with the work of Dr. Chris Snell on metabolic dysfunction in ME/CFS – despite the fact that they have attended the same meetings where Dr. Snell has presented his work. This is not a confidence builder for ME/CFS patients.
Nothing would make me happier than to be wrong about this. I would love to post a correction after an ME/CFS expert panel is appointed. But based on what the IOM is doing with Gulf War Illness, I am frightened about what a similar process would mean for us. An IOM case definition for ME/CFS will be with us for decades. If they get it wrong, we are in big trouble. I hope I am wrong and that the GWI example does not foreshadow how our disease will be defined. But I am scared, and I think you should be too.
What I don’t really understand is how this relates to other similar efforts underway. Didn’t the CDC also want to develop a new case definition? And somehow I remember that there was yet another US federal agency working on something similar, but maybe that was more of a literature review (NIH?, I’m not sure anymore).
Since the CDC are part of the HHS, if I understand the US government correctly, this is a bit confusing to me.
You are correct. There is a case definition process underway at NIH. See the section “A Rose By Any Other Name” for a recap. As far as I can tell, that effort is proceeding as is the CDC multisite study. How those two efforts will be integrated into the IOM contract is a mystery to me.
Jeez, I had no idea. Thanks for keeping on top of this Jennie. We definitely DON”T need non-experts trying to define THIS disorder…
Who did the DHHS confer on this contract? Should they be talking to and getting recommendations from their federal advisory committee? Isn’t that why CFSAC is there – to guide them in decisions like this?
In this case this really seems a bit mysterious. I don’t see how it could be useful in any way to have 3 “official” case definitions and it seems pretty certain that the government wouldn’t want this either. Where is the plan behind this, can it be that they haven’t talked about this between the different agencies and offices? That would seem rather unlikely.
I tried to sign up at the announcement site to follow this, and it told me I already had an account and would receive instructions at my email (regarding how to change my password or something like that). I never did.
How the CDC multisite study will be “integrated into the IOM contract”? I am sure that has never crossed the minds of anyone involved in the IOM project. In fact, one dept. might not be aware of the other’s effort. Hard to believe, but this is the government. I wrote today to Sec. Sebelius using the opposition template that has been sent around (Jennie, will you post that, please, if you haven’t already done so?) and added, “Secretary Sebelius, do you have any idea what your various departments are up to?” I am sure she does not. I am also sure she will never read the letters we are sending. I am also sure the NIH and CDC will continue to do whatever they feel like, regardless of the patient opposition. The Gulf War veterans’ health problems are a perfect example of this: hundreds of thousands of sufferers from all three Gulf wars, and they are treated with no respect and get very little health help. Can we expect better? Scary? It just keeps getting worse.
Billie
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This is very disturbing for any country. Why would the HHS farm this out when the 7 site study has told us they were collecting data for the “evidenced-based” definition because they didn’t want to use the CCC? Oh brother, does Wanda Jones know this? Surely there is some common sense amongst these people – or not? What has all the CFSAC effort been for?
What do the CFSAC board members like Steve (lawyer) have to say when they are begging to be heard at the meetings in this regard to get the evidence right through appropriate testing? It seems when you apply pressure, they simply go the other way – a new route noone ever dreamed of.
Beth Unger has some answering to do for sure. This is more than discouraging for any patient trying to influence things in a healthy way.
There will be powerful psychiatric influence behind the scenes. The attempt will be, by limiting the remit of a literature review to literature supporting the psychiatric position, to get the definition to fit with the DSM 5 category ‘Somatic Symptom Disorder’. There is a similar movement in Europe (see the case of Karina Hansen, Denmark’s Sophia Mirza). Denmark no longer respects the ICD categorisation of ME as a neurological disorder, and have handed the treatment of ME people over to an institute run by psychiatrists, according to the information provided concerning this case. I think that the purpose is clear, and the outcome already determined – this has happened in the UK, and it is very likely that UK psychiatrists will be found to be behind this. Only guessing, of course!!
What, if anything, can we do about this? Sounds like we need a plan.
Thanks again for highlighting Dr. Snell’s work. It actually frightens me that it isn’t getting more attention–especially from the CDC. The study designs are strong and the research is compelling. An objective test to diagnose CFS is exactly what is needed.