Nielk
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Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.
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.Additionally, the Statement of Work specifies that the IOM panel will coordinate with NIH’s Evidence-based Methodology Workshop to “assure that relevant information is shared and key messages are coordinated.” This will give HHS the mechanism to strongly influence what literature is considered as evidence for this broad set of conditions
Contractor shall meet with the NIH Task Leader and HHS personnel within 30 days of the effective
date of the order as a kick-off meeting. The Contractor shall communicate with the NIH Task Leader and
HHS personnel on a monthly basis to discuss the status of the study.
(my bold)Federal agencies are the primary financial sponsors of the Academies' work. Additional studies are funded by state agencies, foundations, other private sponsors, and the National Academies endowment. The Academies provide independent advice; external sponsors have no control over the conduct of a study once the statement of task and budget are finalized. Study committees gather information from many sources in public meetings but they carry out their deliberations in private in order to avoid political, special interest, and sponsor influence.
I noticed that apparent conflict with the SOW too, Nielk. Jennie comments, “If HHS manages or controls the committee, HHS cannot use the definition. If the report is not the committee’s independent judgment, HHS cannot use the definition:”The Institute of Medicine claims that once they start the study, there is no further input from the sponsors of the study, yet by the nature of the Statement of Work, we see how that is not true.
I think it’s worth remembering that the Federal Advisory Committee Act restricts the degree to which HHS can interfere in this IOM panel. The Act states that a government agency cannot use recommendations from an IOM committee created at the request of the government unless a) the committee was not subject to any management or control by an agency or officer of the government, b) no individual on the committee had a conflict of interest, c) the committee was fairly balanced for its task, and d) the final report is the committee’s independent judgment. You can see the full law here.
I noticed that apparent conflict with the SOW too, Nielk. Jennie comments, “If HHS manages or controls the committee, HHS cannot use the definition. If the report is not the committee’s independent judgment, HHS cannot use the definition:”
They've been directed to review too the unpublished data from the ongoing CDC Multi-site Clinical Study of CFS. Dr. Unger has been trying to create a definition using PROMIS questionnaires. Here's Dr. Jason's assessment of these:How will they reconcile the fact that the Statement of Work charges them to "coordinate with NIH’s Evidence-based Methodology Workshop to “assure that relevant information is shared and key messages are coordinated"?
Of course, repeat exercise testing is verbotten.Many have looked to the Patient Reported Outcomes Measurement Information System (PROMIS), as one possible solution as it is a free database of standardized measures that assess patient reported health status. The PROMIS currently includes self-report questions related to the impact of fatigue on functioning, physical feelings of fatigue and limitations. However, the PROMIS does not investigate triggers/causes of fatigue or duration of fatigue. Also, the PROMIS lacks questions assessing fatigue that results from physical or mental exertion; thus lacking questions that tap into post-exertional malaise. Here are several PROMIS questions: In the past 7 days what was the level of your fatigue on most days? In the past 7 days how much mental energy did you have on average? In the past 7 days how often did you run out of energy? In the past 7 days how often did you experience extreme exhaustion?
The SOW mandates coordination, but it smacks of orchestration. By contrast, Health Canada did not interfere with the experts' work during the development of the CCC:This is a very important point. How can they simultaneously work in tandem with them yet, stay out of the process? Impossible!
No strings were attached.Health Canada established the “Terms of Reference”. One stipulation was that at least one member of the panel must be nominated by each of the five stakeholder groups of government, universities, clinicians, industry, and advocacy. There had to be at least ten members on the panel, four of whom could come from outside of Canada. Panel members had to be practicing MDs actively treating and/or diagnosing ME/CFS, or MDs or Ph Ds involved in clinical research of the illness. Their mandate was to develop a clinical definition that addressed a broader spectrum of the pathogenesis of the illness, as well as to provide diagnostic and treatment protocols for medical practitioners. The members of the panel would have autonomy over their consensus document.
(my bold)Health Canada established the “Terms of Reference”. One stipulation was that at least one member of the panel must be nominated by each of the five stakeholder groups of government, universities, clinicians, industry, and advocacy. There had to be at least ten members on the panel, four of whom could come from outside of Canada. Panel members had to be practicing MDs actively treating and/or diagnosing ME/CFS, or MDs or Ph Ds involved in clinical research of the illness. Their mandate was to develop a clinical definition that addressed a broader spectrum of the pathogenesis of the illness, as well as to provide diagnostic and treatment protocols for medical practitioners. The members of the panel would have autonomy over their consensus document.
The IOM aims perversely to balance expertise with ignorance. As Kate Beck explains, “Ultimately, the diagnostic criteria recommended by the committee will be used by physicians/clinicians with and without experience in ME/CFS, so the participation of committee members from both perspectives is very important.”Isn't that accepted practice for establishing diagnostic criteria for diseases? - that all panel members have experience with the disease?
They've been directed to review too the unpublished data from the ongoing CDC Multi-site Clinical Study of CFS.