If You Want Our Support

A week ago, ME/CFS patients found out about HHS’s plan to sole source a contract to the Institute of Medicine to create a consensus case definition for our disease when the sole source notice was published. Today, the CFS Advisory Committee listserv finally got around to telling us about it. Here’s what they said:

This email is to inform you about HHS’ ongoing efforts to address the 2011 CFSAC recommendation “to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.”   In response, NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research, and that HHS was actively pursuing options for a separate effort that would result in a case definition useful for clinicians.  Because the use of and audience for case definitions for research and clinical care are very different, it is important to have separate processes to develop them.

HHS is actively pursuing a contract with the Institute of Medicine (IOM) to convene a consensus committee to develop recommendations for clinical diagnostic criteria for ME/CFS as recommended by CFSAC.  The IOM is unique in the prestige and authority it possesses among U.S. clinicians, researchers and the public. The reports and recommendations released by the IOM are widely accepted and get extensive coverage in both professional and mainstream media. The IOM has a singular reputation as the gold standard for providing biomedical recommendations on difficult, complex and controversial questions in clinical medicine. As the most respected source for medical consensus, the IOM is in a position to bring together experts, the ME/CFS community, and other stakeholders to develop diagnostic criteria for ME/CFS, so that more clinicians can help patients receive the medical care they need and deserve.

Thanks for your support.

Several things strike me as curious about this email, apart from the obvious point that it is a week too late. First, the email refers to the 2011 CFSAC recommendation and not the 2012 recommendation that said a workshop of ME/CFS experts should be convened to consider a definition, starting with the Canadian Consensus Criteria. It’s curious to me that they fail to mention it, particularly since it is one of the Committee’s High Priority Recommendations. Second, the email says the IOM will bring together experts, the community and other stakeholders. Curious, again, because several different sources have suggested to me that this plan to engage the IOM was intentionally concealed from the patient community.

If CFSAC – or more specifically, HHS – wants our support for an IOM process to create a clinical case definition, then they should be willing to address our concerns. I sent the following email to CFSAC with some specific requests:

If the CFSAC Support Team is serious about engaging the ME/CFS community as stakeholders in this process, then I suggest you do the following:

1. Delay the finalizing and signing of this sole source contract until AFTER the CFS Advisory Committee and the ME/CFS community have had a full and fair opportunity to review the Statement of Work and offer input.
2. Ensure through the Statement of Work that the IOM will select its consensus committee from ME/CFS researchers, clinicians and advocates, ensuring a full spectrum of opinions are represented.
3. Tell us when the CFSAC voting and ex officio members were informed of the plan to contract with the IOM, how they were informed, and in what context.
4. Tell us the cost of this contract, and where the funding is coming from.
5. Explain how this definition process fits with and is coordinated with the NIH and CDC efforts.

Finally, I note that you may have more success in getting support from the patient community if you inform us of significant developments in a timely fashion – not after we discover the information through other means and mount a response.

Sincerely,

Jennifer Spotila

I will report any response that I receive.