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.