Comments to the DHHS CFS Adivsory Committe
Public Testimony: May 11, 2011
I’m happy to speak with you today and to see so many of you again after the recent State of the Knowledge Workshop. At the risk of being part of a broken record….I came away from that workshop so encouraged. And so demanding of your leadership!
In this fiscal environment, OMB more than ever is scrutinizing common functions across agencies and departments and questioning their respective roles and contributions. This Committee could coordinate CFS research in a way that’s not been done before and in a way that could Solve CFS relatively economically—and help the participating agencies justify their relevant programs and funding.
The State of the Knowledge workshop demonstrated that there are remarkable researchers, from across the critical disciplines, who are dedicated to solving CFS. There’s a strong foundation of research already built over the last 20 or so years. The key is building on it—filling the gaps.
So how do we align the resources and provide the common foundation necessary to do it? Interdepartmental and intradepartmental cooperation and alignment are vital to positioning the range of inter-disciplinary studies needed to get to the biomarkers, diagnostics, treatments, and cures necessary to solve CFS.
Dr. Monroe of CDC, in his remarks at the SOK, showed insights into what needs to be done, efforts in which CDC could play a critical role if it chose to position its program and its resources to lead with vision and purpose. Dr. Monroe spoke of, among other things:
- the need for “reverse translational” research—going from the bedside to the bench instead of the other way around
- the complexity of the infectious disease element—is it one or multiple hits; is it a hit-and-run or a persistent attack
- systems biology and the need to use new laboratory and analytic tools to understand how the multiple systems can be so disregulated, how that disregulation varies by patient, and how to intervene
- progress towards biomarkers and the need to knit the potential individual biomarkers (exercise, cytokine, genomics, etc.) together to determine what makes sense for diagnostics and interventions for different patients;
In her summary of the SOK, Dr. Vernon summarized the current gaps in knowledge and research studies, including:
- The issues of terminology and varied case definitions, which blur the lines between research and clinical medicine and create problems in comparing study results (about which Dr. Jason spoke so compellingly at the SOK).
- The lack of standard operating procedures for studies, the lack of common data elements, and the lack of coordination and collaboration.
- The need for study design to account for subtypes, demographics, disease and healthy controls, biomarkers, time course data, clinical trials, early detection, pediatric v. adult presentations, and outcome measures.
- The varied types of studies needed, including longitudinal, natural history, early detection, pediatric v. adult CFS, genetics and clinical trials.
- The need for reproducible, replicated, validated biomarkers.
- Finally, the need for more research money.
That last may be out of reach. Dr. Mangan himself has said that there will be no new set-aside $ from NIH. So given that, what do we do? Dr. Cook yesterday asked the exact right question: how do we sustain the momentum coming out of the SOK? And I don’t think he—or we, for that matter—got a good answer from HHS to that question.
I think it boils down to using the current resources, and the respective agencies’ and researchers’ many talents, as effectively as possible. And it probably means making the most of the existing grant-making processes, as problematic as they are for this illness. So it seems to me that this Committee, if properly staffed and supported by HHS, could accomplish a lot within these constraints if it focused on nudging and cajoling things in the right direction and working to align researchers and resources within this environment.
And here’s one obvious thing to do that this Committee is perhaps uniquely positioned to accomplish: lay the infrastructure. This Committee could resolve the questions of SOPs and standard data elements, let alone some of the other issues raised at the SOK that continue to plague our being able to compare and truly understand research findings. This Committee, again, if properly staffed, could lay a foundation that would radically enhance the value of all subsequent research, because if new studies continue to be done using the different case definitions, the different SOPs, the different data elements, etc., we’ll have bought ourselves more study results, sure, but we’ll have even more of the same kinds of persistent questions about what they mean… And what we really need are answers, not more questions.
Amy Squires is a member of the Board of Directors of the Solve ME/CFS Initiative .
(Amy’s testimony begins :40 into the recording.)May 11, 2011