During the development of the proposed DHHS/IOM project, it seems that DHHS did not involve CFSAC members or let them know what was going on. We do not know if ex-officios were involved at all – because the project was progressed without the knowledge of, or input from the ME community. When advocates contacted some of our clinical and research experts it turns out that they had no idea about the proposed project until the advocates brought it to their attention.
For some time now, DHHS has wanted to use non-experts in the definition process – CFSAC DFO (designated federal officer) Nancy Lee has pushed really hard on that on a number of occasions. Non-experts? – to define a disease that many non-experts know little if anything about and that many don’t believe is real? Somehow that does not inspire warm and fuzzy feelings of comfort and confidence.
In May 2013, at the CFSAC meeting, Beth Unger of the CDC indicated that she is not certain post-exertional exacerbation (PEM) should be a required symptom of ME. At least one other person on the CFSAC has indicated that they think PEM is optional and should not be a required in a definition of ME. Yet, ME experts agree that PEM is a cornerstone, a hallmark of this illness. Is a definition that does not include illness hallmarks one that can accurately describe the illness?
DHHS appears to have changed its position on consensus definitions and who they believe to be the most appropriate groups for developing them. The minutes from the CFSAC Oct 2012 meeting indicate that Secretary Sebelius believed that definitions need to come from the medical community:
“In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community. . .
I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.”
Yet now, DHHS wants to develop a consensus clinical diagnostic criteria for ME. (“The Committee will consider the various existing definitions for chronic fatigue syndrome and develop consensus clinical diagnostic criteria for this disorder.” https://www.fbo.gov/index?s=opportunity&mode=form&tab=core&id=7fafc35816ee932dc44d6c319937b366&_cview=1)
We already have the CCC (http://www.cfids-cab.org/cfs-inform/CFS.case.def/carruthers.etal03.pdf) . We already have the ME-ICC (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3427890/) . Creation of another consensus criteria would take significant time. Implementation of the criteria would add time on top of that. Dissemination of educational material would add even more time. And if the creation of another consensus criteria is done by a group that includes lots (or any) non-experts, we will likely be at least five years further on the road to nowhere or backwards.
Why is HHS pursuing any “other mechanisms to accomplish this work” (“HHS will continue to explore mechanisms to accomplish this work.” https://www.fbo.gov/indexs=opportunity&mode=form&tab=core&id=dfb4054e6f31df6d3969feea989825b8&_cview=0 ) instead of using the work of ME experts?
All of this seems a long way off from the CFSAC recommendation of Oct 2012:
“CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Definition for discussion purposes.” http://www.hhs.gov/advcomcfs/recommendations/10032012.html
DHHS still has not given a response about the allegations made at the May meeting.
And with this secretive DHHS/IOM proposal, DHHS has shattered the little remaining trust many people had in them.
The draft strategic plan for DHHS F2014-2018 was released earlier this week and one sentence in it reads:
“Every operating and staff division within the Department is committed to ensuring the efficiency, transparency, accountability, and effectiveness of HHS programs.” http://www.hhs.gov/open/recordsandreports/strategic-plan/goal-4.html
Have we seen evidence of this transparency?
Has DHHS ensured the effectiveness of the CFSAC program by implementing CFSAC recommendations?
Has DHHS demonstrated its accountability to the CFSAC and the ME community by their actions?
Do DHHS actions demonstrate that they care about what we have to say, that they respect and value our input and that of ME experts?
After all, according to the CFSAC charter, the CFSAC is supposed to be made up of experts in ME – experts selected by and appointed by DHHS. (“Of the eleven members, seven shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to CFS; four shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with CFS.” http://www.hhs.gov/advcomcfs/charter/index.html ) —
To what extent does DHHS engage with the CFSAC and demonstrate that they respect and value the input provided by the CFSAC?
Can we continue to believe that their intentions for us are honorable and truly in our interest?
Or does it seem that nothing that has been said about ME, to DHHS for the past decades has yielded significant positive results for us?
Lots of questions…..