When I posted the other day about the CFS Advisory Committee’s list of High Priority Recommendations (pdf link), I said that I had done some digging and that what I found wasn’t pretty. To be blunt, what I found is that the secret process used to create this priority list violated established Federal procedure, including the CFSAC’s own Charter and Bylaws. By acting in this manner, the CFSAC has disenfranchised the very stakeholders they exist to serve: the patients. And if the CFSAC continues to act this way, then CFS patients will be deprived of the one venue we have to observe and shape HHS policy on our disease.
Two sources close to the process have confirmed that the subcommittees generated the priorities for this document. Selecting from the Committee’s recommendations over the years, the Education/Patient Care/Quality of Life Subcommittee and the Research Subcommittee generated a short list of recommendations that they felt were highest priority. I have not been able to get copies of those subcommittee lists, so I don’t know whether their lists were combined into the final document without further editing.
But there’s a problem. At some stage in the process, either in subcommittee or upon final compilation of the document, recommendations were altered. The fourth recommendation in the document covers the issue of research funding, and here is how it appears in the High Priority document:
ME/CFS is an illness with enormous economic and human costs. The April 2011 NIH State of Knowledge Workshop identified a number of gaps in what is known about the illness. To address these gaps warrants an interagency effort comprising, but not limited to, NIH, CDC, and AHRQ. Further, the focus should be on interdisciplinary discovery and translational research involving interacting networks of clinical and basic science researchers. Areas to be examined would include the following: identification of patient subsets for detailed phenotyping and targeted therapeutic interventions, biomarker discovery, systems biology approaches and disability assessment. To accomplish this, specific issues would include:
a. Fund specific research for identification of biomarkers and etiology of CFS
b. NIH or other appropriate agency should issue a Request for Applications (RFA) for specific clinical trials research on chronic fatigue syndrome/myalgic encephalomyelitis. (5/11)
So it looks like this recommendation with two sub-parts was made in May 2011, right? Nope. This is an amalgam of three separate recommendations made at three separate meetings, and a sentence was deleted from one of them. Sub-part (a) has actually never been passed by the Committee with those precise words, but seems to be an edited version of a recommendation passed in October 2009. Sub-part (b) was passed by the Committee in November 2011. But the main part of this recommendation differs significantly from the version actually passed by the Committee in May 2011. The original recommendation ends with this sentence:
To facilitate the above goal, CFSAC recommends that ME/CFS research receive funding commensurate with the magnitude of the problem and that the NIH (and/or other appropriate agencies) issue an RFA specifically for ME/CFS.
That deleted sentence is critically important to the whole recommendation. It’s a statement by CFSAC that research funding must match the magnitude of the disease burden and that NIH should issue an RFA. The altered version that appears in the High Priority document says nothing about commensurate funding. It is a new recommendation created by smashing three recommendations from three different meetings together, deleting a critical sentence, and dating it all as coming from May 2011. I don’t know who did this. Was it done by one of the subcommittees? Was it done by Dr. Nancy Lee or other HHS personnel? There is no way to know, because this all happened in secrecy.
Behind Closed Doors
As a Federal advisory committee, the CFSAC can only make recommendations at open public meetings (barring a few exceptions not relevant here). The law requires that advisory committees discuss their recommendations in public, that they hear public comment on the issues, and then vote on recommendations in public. That is the whole point of the Federal Advisory Committee Act. But the CFSAC did not follow that procedure in creating the High Priority document.
Selecting the highest priority recommendations to forward to the Secretary is an issue that should have been discussed in public. The public should have had an opportunity to provide input on which recommendations we think are highest priority. We should have been able to listen to the committee deliberate and discuss why one recommendation should be selected over another. And there is no doubt in my mind that the entire committee should have voted on this High Priority list in public. This is especially true since the recommendation I examined above was materially altered and then combined with two other recommendations.
In fact, the process used to create the High Priority document violated both the Bylaws and Charter of the CFSAC. The CFSAC Bylaws state:
The advice of a subcommittee shall be reported to the full committee. The full committee shall review reports and any recommendations made by the subcommittees. Findings will be discussed at a public meeting of the full committee, at which time the full committee will determine appropriate action.
But we know that this did not happen. The advice of the subcommittees, in the form of the recommendations they designated as high priority, was simply compiled into the final document. And what happened next violated the CFSAC Charter:
The established subcommittees shall provide advice and/or make recommendations to the parent Committee. The subcommittees may not report its findings directly to any Federal official unless there is specific statutory authority for such reporting. (emphasis added)
But this is precisely what happened. The subcommittees selected their recommendations, the document was compiled, and then it was shared with Assistant Secretary Dr. Koh. Recall that Dr. Nancy Lee told me in her email of January 24, 2013, “CFSAC leadership discussed this priority list with Dr. Koh last year; he was very supportive.”
Here is the problem: no one told us. The subcommittees made lists in secret. The lists were combined in secret. The final document was discussed with Dr. Koh in secret. This document was not discussed in public by Dr. Lee or CFSAC members, and it was not released to the public until this month – an entire year after it was created. In my opinion, this violates the Federal Advisory Committee Act, as well as the CFSAC charter and bylaws.
Why does this matter? Because the CFSAC is being held out as the main place we can offer input into HHS policy about CFS. In his letter to advocates on September 11, 2012, Dr. Koh said, “CFSAC provides a mechanism to ensure stakeholders are engaged and have opportunities to offer input.” Patients are not being included in other CFS-related policy efforts like the HHS Ad Hoc Working Group. We are constantly being told that CFSAC is the venue where we can offer our input.
But shenanigans like these – where the committee works behind closed doors and communicates recommendations to the Assistant Secretary without public discussion, public input or public vote – deprive us of our ability to participate in or observe the formulation of recommendations to the Secretary. If this trend continues, if CFSAC continues to do substantive work without bringing it back to the full committee in public, then we are effectively disenfranchised. We cannot allow that to happen without a fight.