Public Citizen Acts to Correct CFS Advisory Committee Violations of FACA By Jennifer Spotila, February 21, 2013 ME/CFS is on a short list of diseases (such as HIV/AIDS, breast cancer, and autism) that has a Federal advisory committee. The CFS Advisory Committee (CFSAC) is discretionary, formed at the request of the Secretary of the Department of Health and Human Services, as opposed to a committee mandated by Congressional legislation. The CFSAC was created to advise the Secretary on issues such as healthcare, the science and definition of CFS, and other public health, research and educational issues related to the disease. Over the last decade, CFSAC has made more than 70 recommendations to the Secretary on many issues, including research funding, Centers of Excellence, provider education, pediatric issues, case definition, name change, and more. But, in January 2012, the Committee acted in secret to create a separate list of high priority recommendations, and by doing so it violated its own Charter and the Federal Advisory Committee Act. The reasons for the secrecy are still unknown. Background At the November 8, 2011 CFSAC meeting, Dr. Gailen Marshall (now Chairman of the CFSAC) suggested that the Committee narrow down its recommendations to just a few high priority items. In his words, “The trees are getting lost because of the forest. So cut most of the forest down.” (CFSAC Minutes, November 8, 2011, p. 43) Over the next two months, the CFSAC subcommittees selected a few recommendations from the list and produced a document titled “High Priority Recommendations from CFSAC, January 2012.” Committee leadership discussed the list with Assistant Secretary for Health, Dr. Howard Koh, that same month. Despite the good intentions that motivated the effort, the way the document was created violated both the CFSAC Charter and FACA. The Charter requires that the subcommittees provide advice and/or make recommendations to the full Committee, and not to Federal officials. But this is precisely what they did here. The subcommittees did not report to the full Committee; their work went straight to Dr. Koh and was characterized to him as recommendations from CFSAC. Not only did this violate the Charter, it plainly violated the Federal Advisory Committee Act as well. One of the purposes of the FACA is to ensure that the public can observe and provide input into the work of Federal advisory committees. The CFSAC can only make recommendations at open public meetings. FACA 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 process was not followed in this case. These violations of the Charter and FACA are not mere technicalities. The process is designed to give the public – us – a chance to participate in and observe the formulation of recommendations by the Committee. It protects our right as stakeholders in the Committee’s work to have a voice in the process. Using the subcommittees to generate recommendations to Dr. Koh not only violated those safeguard requirements but also subverted our ability to identify what we think the highest priority recommendations should have been. The Recommendations The subcommittees reviewed the list of previous CFSAC recommendations, and chose seven high priority areas, summarized below. The document uses the wording of those original recommendations, except for one. Clarify the Department’s process for considering the CFSAC recommendations. Classify CFS in the ICD-10-CM in section G93.3 (“Postviral fatigue syndrome”) along with myalgic encephalomyelitis. (Currently CFS is excluded from this classification. ME is not.) The Interagency Working Group (an ongoing internal effort at HHS) should pool resources to create Centers of Excellence. Fund more research. (The wording on this priority was significantly changed. See below) Adopt the term “ME/CFS” across HHS programs. Create a task force to focus on coordinating support for children and young adults with CFS. Increase public education through an awareness campaign. Perhaps that list doesn’t look too bad to you, but there are some notable gaps. First, provider education is not included in the list despite the many recommendations from CFSAC on the topic. Why did the subcommittees think that bureaucratic expediency was more important than educating doctors and health care providers? We do not know, because the Committee never discussed it in public. Second, several important recommendations made after the High Priority list was created were not integrated into the priorities, including the removal of the CDC Toolkit and a meeting of ME/CFS experts to discuss the case definition. The CFSAC recommended the removal of the Toolkit because they believed it was inaccurate and harmful in promoting CBT/GET. One of the biggest problems being tackled right now is the revision of the case definition. (The CDC Fukuda case definition is almost universally considered inadequate.) Currently, the CDC and NIH and the CFSAC are all undertaking separate efforts. The CFSAC recommendation was to sponsor a meeting of ME/CFS experts to discuss the case definition, which is a necessity. Because the High Priority list was never discussed in public, we have no idea how – or if – these important 2012 recommendations fit into the “high priority.” Third, the recommendation to fund research was significantly altered from its original wording, which profoundly changed its meaning. The previous research recommendations included, among other things, identification of patient subsets, biomarker discovery, and disability assessment. However, the original recommendation passed by the CFSAC specified that research should receive funding commensurate with the magnitude of the problem. Given the fact that the prevalence of ME/CFS is somewhere between 1 and 4 million people, with an economic loss in the billions of dollars, the magnitude is enormous. The “high priority” version deleted this stipulation entirely, diluting the specificity and strength of the original recommendation. Public Citizen Steps In When I discovered that the CSFAC had violated its own Charter and FACA, I reached out to Public Citizen, a watchdog non-profit that has litigated cases under FACA in the past. They moved quickly to send a letter of protest on my behalf to the Acting General Counsel of HHS on February 14, 2013. The letter points out that the FACA violations deprived “Ms. Spotila and the public generally of important rights to observe and participate in the advisory committee process.” Public Citizen asked that the General Counsel “act to ensure that CFSAC complies with FACA and with its own charter going forward. We also ask that you return the January 2012 ‘High Priority Recommendations’ document to the full committee for review, so that whatever action CFSAC chooses to take regarding those recommendations or any other transmission to HHS be debated and approved by the full committee, in public, as required by FACA.” Public Citizen sent their letter on February 14th, and by February 18th the High Priority list was removed from the CFSAC website. To date, there has been no other response from HHS. It is my hope that the CFSAC will correct the process and mindset that led to this situation. Why does this matter? The CFSAC is the only venue where patients can offer our input into HHS policy about CFS. For example, patients are excluded from other CFS-related policy efforts like the HHS Ad Hoc Working Group. By acting in secret, the Committee not only violated its charter, it disenfranchised the very stakeholders it exists to serve: the patients. 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. More Information Letter to Department of Health and Human Services Regarding the Chronic Fatigue Syndrome Advisory Committee A Public Citizen Highest Priority, Part One Highest Priority, Part Two For updates, visit Occupy CFS, Jennifer Spotila's blog about the politics, research, medicine, and personal experience of life with ME/CFS. ________________________________________ Jennifer Spotila has been disabled by ME/CFS since 1994. She has been writing about ME/CFS and advocating for more research funding since the late 1990s. She served on the Board of Directors of The CFIDS Association of America from 2006 to 2011, has testified before the CFS Advisory Committee on multiple occasions, and given many media interviews about the illness.