Controversies continue to swirl around the Institute of Medicine’s study to create a clinical case definition for ME/CFS. I have new information to share, as well as important information about the process IOM uses for its studies. In preparing this article, I corresponded with Jennifer Walsh in the Office of News & Public Information at the Institute of Medicine, and spoke with a number of ME/CFS advocates. The IOM follows the same basic process for every study. This four stage process is described on the IOM website, and is well underway in the ME/CFS study.
First Stage, Complete
In stage 1 of the study, the IOM staff works with the study sponsors to define the formal “statement of task.” For the ME/CFS study, the sponsors are HHS and the Social Security Administration (an error on the IOM webpage originally identified the sponsor as NIH but that has been corrected). The statement of task “defines and bounds the scope of the study, and it serves as the basis for determining the expertise and the balance of perspectives needed on the committee.” This stage has been completed and the statement of task has been posted. This statement of task is distinct from the Statement of Work provided to me by HHS, but uses language pulled directly from that document. Jennifer Walsh told me that stage 1 is complete, and the staff has moved on to stage 2.
Second Stage, Underway
In stage 2 of the study, the committee is selected and approved. Obviously, the composition of the committee is one of the most significant influences on the final outcome, and so great care must be taken at this stage. Committee members are screened for conflicts of interest, defined as:
any financial or other interest which conflicts with the service of the individual because it could significantly impair the individual’s objectivity or could create an unfair competitive advantage for any person or organization. The term “conflict of interest” means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee.
It is critically important that we understand this. A point of view or bias is not always a conflict of interest. This is good and bad for us. It’s good because it means that the experts who signed the letter to HHS should not be automatically disqualified for having done so. Their publicly expressed point of view should not, by itself, prevent their appointment to the committee. But it’s bad for us because it means that those who believe ME/CFS is a psychological disorder will also not be automatically disqualified.
At the beginning of committee selection, the IOM solicits nominations from a wide range of sources. IOM sent requests to multiple ME/CFS organizations and individuals. I have confirmed that at least
five six organizations and multiple individuals (including myself) submitted nominations to the IOM. PANDORA and Rocky Mountain CFS/ME & FM Association are the only organizations that have released their nomination lists to the public. The CFIDS Association submitted nominations, but told me they would not be releasing their list. The other three organizations have been reticent to state even the fact that they submitted names, let alone release their lists. Given the roasting that PANDORA has experienced for participating in the process, this reluctance is not surprising. For the record, I nominated Dr. Leonard Jason, Dr. Lucinda Bateman, Dr. Peter Rowe, Dr. Chris Snell, and Dr. Lily Chu.
Once nominations are received, the IOM reviews and approves a provisional slate for the committee. That provisional slate is posted on the study website, and the public has 20 days to comment. Jennifer Walsh told me that they plan to post the slate by the end of November/beginning of December. The publication of the list will be announced via a listserv created for this project, and you can sign up for that listserv on the project page. Advocates, be ready. The slate will come out in close proximity to Thanksgiving and the CFSAC meeting on December 10th-11th. Our comments on the slate will need to be prepared and submitted quickly.
At the same time as the public comment period, the IOM will schedule the first committee meeting based on the members’ availability. At least part of that first meeting will be closed to the public, and will include a substantial discussion of potential conflicts of interest. Based on that discussion, background forms, and public comment, the committee slate is finalized and approved.
The third stage of the study process begins at the first meeting (with the provisional committee slate). During this stage, the committee gathers information, deliberates, and drafts their report. Information is gathered through public meetings, submissions from outside parties, reviews of scientific literature, and investigations by members and staff. Efforts are made to gather input from people who have special knowledge of the issue under consideration. The statement of task for this study specifically includes stakeholder input from patients and practicing clinicians.
Walsh told me that the committee and staff will decide how best to engage the public in this study. Public meetings are announced at least 10 days in advance, and webcasts have also been used in other studies. The specifics will be determined by the committee itself. However, Walsh also said that the public can submit outside materials at any time during the study by sending them to
firstname.lastname@example.org (Updated: IOM asks that we use email@example.com). These submissions are subsequently available to the public through the public access folder of the project.
I hope ME/CFS advocates will take advantage of this opportunity. We have produced a number of research papers in the past several years, and I would love to see organizations and individuals do so here as well. We have a lot to say about the case definition, and we should take the time to prepare well-written statements that reference the scientific literature as well as our experiences. I sincerely hope that we will invest the time and energy required to prepare such statements for the committee.
In the final stage of an IOM study, the committee’s draft report is reviewed by independent experts with a range of views. Their comments are provided anonymously to the committee, and the committee must address every single comment. The report is then finalized, and any committee member may write a dissenting opinion. The study sponsors (HHS and SSA) do not have an opportunity to suggest changes to the report, and do not see it at any drafting stage. The report is published, and at that time the names and affiliations of the outside reviewers are disclosed.
What We Need to Do
It is important to note that efforts to cancel this study continue. More experts signed on to the letter to HHS on October 26th, increasing the number of signatories to 50. On October 28th, more than 60 advocates sent a letter to HHS in support of those experts. Petitions and letter campaigns continue. In addition, PANDORA submitted a number of questions to Dr. Wanda Jones at HHS, and were told a response would be prepared. Controversy abounds within the advocacy community, and I’ll have more on that soon. But for those who want to follow the IOM study progress and contribute to the process, I suggest the following:
- Sign up for the study listserv
- Be ready for the provisional slate announcement at the end of November/beginning of December
- Submit comments on the provisional slate during the twenty day comment period
- Begin drafting written submissions to the committee