The underlying tone of the introductory statements was defensive, no doubt due to input from ME/CFS advocates and experts who believe the IOM process to be a waste of time and money, if not outright harmful. There were several references made to the "rigor" of the process, which, in Dr. Clayton's words, made "everything else pale in comparison," and an emphasis on procedure.
There was, however, no mention of specifics. While it was made clear to those listening that many steps would be followed, that these steps would be reviewed and overseen, and that the final product would be examined and re-examined, one crucial question remains unanswered:
If the IOM review is supposed to provide the basis for a new case definition, exactly who determines which material will be read by the committee? Do they plan on reading everything that has ever been published on ME/CFS? If not, how do they intend to cull their material? Dr. Erdtmann mentioned that all "outside" material would be available to the public. Is there "inside" material? If so, what is it?
Unfortunately, we will never know the answer to these questions. This is a "confidential" process, in which members of the public will not have access to the materials, the interim reports, or anything else of substance.
While the non-expert members of the committee demonstrated their professionalism by asking appropriate questions, it is clear that they are in over their heads. Given the limitations imposed on most of the committee members by sheer lack of knowledge, it is hard to imagine how they will be able to sort through the vast, contradictory corpus of literature on ME/CFS. They have neither the perspective that long association with patients brings, nor the critical capacity that a thorough understanding of our political history provides.
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By Erica Verrillo
On January 27, 2014, the Institute of Medicine held a public meeting concerning the IOM’s review of diagnostic criteria for ME/CFS.
The first half of the meeting consisted of presentations by government and IOM representatives. The second half included presentations from patients and patient advocates, as well as public comments.
This article covers the initial presentations, in which the IOM process was described.
- Rick Erdtmann outlined the four steps of the IOM study.
- Ellen Wright Clayton, Committee Chair, welcomed the participants and established the limits of the public session.
- Dr. Nancy C. Lee, representing the sponsor of the study, HHS, talked about some of the background that led up to the IOM review.
You can watch the presentations HERE.
You can read information about the committee members HERE.
It is not too late to submit comments to the IOM Committee. Send your comments to: mecfs@nas.edu
Rick Erdtmann – The IOM Process (7:24) (Video)
Dr. Erdtmann is the Director of the Board on the Health of Select Populations, which is in charge of the committee. He outlined the four stages of the IOM study.
- Define the problem. When this is accomplished, the committee prepares a Contract of Work.
- Select experts to author the report. The selection of a provisional committee is accomplished through an “extensive search.” The provisional committee is then reviewed to ensure that there is no conflict of interest, and that there is a “proper balance of views.”
- Gather information based on presentations and research by the committee and staff. Any information from outside sources is listed in files available to the public, but the actual deliberations of the committee are not revealed. A confidential report is then drafted.
- Peer review process. Volunteer reviewers who roughly match the expertise of the panel are nominated to review the draft. That slate is subject to internal academy review “above and beyond” the purview of the study committee. The reviewers are asked to make critical comments, to clarify errors and offer new insights and suggestions. Reviewer comments are submitted anonymously, and the committee then addresses each comment and modifies the draft. The Report Committee oversees the review process, and ensures that the comments are addressed. Then the report is released to the sponsor and to the public.
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Dr. Clayton welcomed the committee and expressed her enthusiasm for the project. She then stated the committee’s task, which is “to evaluate comprehensively the current criteria for the diagnosis for ME/CFS.” Dr. Clayton stressed that the public session was for information gathering only, and that any views expressed by committee members were not to be taken as indicators of the committee’s position. While questions were not allowed from the floor, Dr. Clayton pointed out that “probing questions” would be posed by committee members. After repeating several times that the process of review would be rigorous, Dr. Clayton then introduced the sponsor’s representative. [HHS is the sponsor of the IOM study.]_________________________
Nancy Lee - Background and Charge to the Committee (15:51) (Video)
Dr. Nancy C. Lee is the Designated Federal Officer for the Chronic Fatigue Syndrome Advisory Committee (CFSAC). Dr. Lee reported that in 2012 CFSAC recommended that HHS convene a workshop to reach a consensus on clinical and research case definitions for ME/CFS. The Secretary of HHS asked IOM to use its consensus process to provide guidance to the broader medical community on how to identify and diagnose ME/CFS in the clinical setting. This includes primary care providers as well as some specialty groups. HHS asked that four specific tasks be addressed. The charge of the IOM committee is to address four specific tasks:
- Conduct a study to identify the evidence for various diagnostic clinical criteria for ME/CFS using a process with stakeholder input, including practicing physicians and patients.
- Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology.
- Recommend whether new terminology should be adopted.
- Develop an outreach strategy to disseminate the definition nationwide to health professionals.
"As you probably know there has been support from advocates, as well as some of the members of this committee, for the Canadian Consensus Criteria of 2003.
Criteria should account for different sub-populations, such as children," she said. “The committee may well decide that different criteria are needed for the different entities that fall under the broad umbrella of CFS.”The third task is to evaluate the terminologies for ME/CFS. These terminologies include but are not limited to: neuro-endocrine immune disorder, myalgic encephalomyelitis, chronic fatigue syndrome, and chronic fatigue immune deficiency syndrome. Different names may be warranted.
“Please know that there are many people – scientists, clinicians, advocates - who believe the name ‘chronic fatigue syndrome’ does harm to patients. I agree.”Dr. Lee asked that the committee recommend strategies to disseminate these criteria nationwide to patients, and health care professionals. “Pushing out the criteria to a wide audience of health professionals is such a critical need. Whatever the committee develops needs to get into textbooks, widely read journals, and be at the top of a google search.”
Dr. Lee asked the committee to coordinate their efforts with two ongoing efforts: The CDC multi-site study and the NIH Pathways to Prevention (P2P) Program for ME/CFS.
Dr. Lee closed her presentation with the statement that “Patients and providers need help now.”
Dr. Lee Q&A (7:08) (Video)
Question - Dr. Clayton: There are two other efforts that we will hear more about. But I would like to hear from you how these efforts are going to interweave to create a coherent whole.
Answer: A better answer to your question is going to come from my two colleagues. For the CDC, that was designed to gather data to address the issue of what are their symptoms, what are their lab values. So, they are gathering data. The hope is that that information will provide a large body of information.
The other part of the recommendation that we received from CFSAC in 2012 asked for research definitions to be developed. So, the NIH has sort of taken that, and thought about it in different ways. So they are going to develop a research [definition?] going forward, and they are going to provide a thorough review of existing case definitions. So there is going to be some overlap.
Question – Dr. Lily Chu: Patients have had some questions about what type of patients this case definition will apply to. So, I am thinking about a patient coming in to see a typical, average doctor; how do they go about diagnosing CFS? That is my framework. So, I want to make sure that that is the same framework HHS is thinking about.
My second question concerns the different case definitions that are listed - that’s a starting point. But if we have points that we want to add to that case definition to make a new case definition that the panel believes to better represent patients, then that’s what we should be aiming for, not just the existing definitions. Is that right?
Answer: It’s whatever you decide. It could be the existing one, it could be the 2003 [CCC] if you all decide that’s a very good definition. If you decide you like the 2003, or something else but you want to tweak it a little or come up with whole new measures, because the 2003 is eleven years old. So, we defer to the expertise that is assembled around the table; we defer to you.
But, again, to go back to the first point, I am hoping that this will be something that can be taught to many, many providers, so that when they come in they can put it on their differential diagnosis, so they can say this is what people have to they can get on the phone and ask an expert about it. It’s what you do when you don’t see something commonly, but you know you have to make a good diagnosis.
Question – Nancy Klimas: I’m trying to be clear because I actually serve on two panels, the NIH working group and this one as well. This group is looking for a clinical definition – as in the practice of medicine.
Answer: This could be for researchers, but this is also for the doctor or the nurse practitioner or the PA, or other health care providers that somebody walks in and it’s for them to help this person who has this diagnosis that they are not quite sure what it is. Research may come out of this. But this is really for helping patients get the kind of care they need.
Question – Nancy Klimas: In a clinical sense sub-grouping would also be addressed.
Answer: Sub-grouping is good.
Question – Betsy Keller: I have a question about the charge of ultimately creating the set of criteria that will help with the diagnosis. That’s part of the statement of task that you just described to us. Can you explain why HHS stopped there, when you have just acknowledged that it’s very difficult for patients to find providers for the illness? Are there any plans for HHS to provide a website so patients can find qualified providers to treat the disease?Answer: I think that the government does not endorse specific providers. When we have the report we will hopefully work with the big organizations, but we don’t have the product that we can push out right now. CFSAC has a committee that is looking at educating primary care providers. A lot of that is outside the government.
Question – Betsy Keller: I am concerned about getting this information in some form that is accessible to the patients, because we’re way behind the eight ball.
Answer: Right, and so that’s task four – for you all to help us. We have the advisory committee [CFSAC] that can help us with that as well.
Question – Nancy Klimas: Task three is to address the name. There has been a tremendous amount of public discussion on this that the CFSAC minutes
would reflect. In your mind’s eye is there a role for additional public input?Answer: Absolutely.
Question – Nancy Klimas: In my mind I split it into two things. We’ll hear again and again about the name being harmful. What we need from the committee is constructive advice on how to go forward. Not to spend many hours discussing what is out there, but where do we go from here? And as a committee member, I would welcome public input.
Answer: I think that we really look to the stakeholder advocacy community for suggestions on that task.
Question – Nancy Klimas: I don’t understand the mechanism of how that would happen. Today we have this public testimony, and I am sure it will be very useful. Is there some way to have to input of the public as the process goes on about various elements?
Answer – Carmen Mundaca: We have established an email, and we have delivered comments to you. This email will be open throughout the process, and there is no deadline for submitting. We will have that as a regular means of communication with the public. The email is: mecfs@nas.edu
Answer – Lily Chu: We are going to talk further about how public input will be gathered and put into the final documents.
Dr. Clayton: I confess that if we get through federal presentations sooner than anticipated that gives us time for public input and I’m not too sad about that.
