A keystone of successful efforts to combat complex diseases like CFS has been lacking for thirty years: strategic coordination. Other illnesses, including autism and Alzheimer’s, are now benefiting from coordinated federal strategic plans. In the last year, the Department of Health and Human Services has taken steps in that direction for CFS, but at present this initiative is in a black box and completely inaccessible to those of us who will be most affected by the outcomes of the effort.
In April of 2011, the NIH hosted the long anticipated State of the Knowledge Workshop. Secretary Sebelius sent a letter to the meeting, saying in part, “I want to assure you that several agencies within the Department of Health and Human Services (HHS) are working together with the Chronic Fatigue Syndrome Advisory Committee and advocacy groups to develop interdisciplinary initiatives that will address important aspects of this illness, including improved diagnosis and treatments.” (Letter from Secretary Sebelius, April 7, 2011.)
No details were provided at the Workshop, but a little more information came out at the May 11, 2011 CFSAC meeting. Assistant Secretary Dr. Howard Koh said that there was a “high-level leadership meeting with the Secretary on ME/CFS” in March 2011, and that “they reviewed the status of research, clinical care, education.” According to Dr. Koh, CFSAC ex officio members were at the meeting and that “agency heads of the departments” had met several more times since. (CFSAC Meeting Minutes, May 22, 2011 p. 4)
I saw this as a sign of progress. Advocates, including myself, had repeatedly asked that the Secretary to be personally briefed on CFS and the recommendations of the CFSAC. In my public comment at the May 28, 2009 meeting I said, “Until Secretary Sibelius recognizes CFS as the crisis that you already know that it is – until word comes from the top down that CFS is a fire – I fear nothing will change.” Was this March 2011 high level meaning a sign that things might be changing?
At the November 8, 2011 CFSAC meeting, Dr. Koh announced a new working group formed by the Secretary in an effort to coordinate work on CFS across the Department. “The group will report back to the Secretary an inventory of efforts in the field of CFS going on throughout the department. The group will do its best to coordinate strategies across the department in a more coherent fashion. The group will make its work available on the CFSAC website.” (CFSAC Meeting Minutes, November 8, 2011, p. 17) Dr. Nancy Lee said that the Secretary was asking each agency to send a representative to the working group who has decision making authority, and that she was chairing the working group. (p. 43) The next day, Dr. Lee said:
This is still a work in progress. The process was begun out of the Office of the Secretary. We found out about it after it had been going on for several months and we have been involved in it ever since. There has been a preliminary and currently incomplete inventory of things that various agencies are doing in CFS. There is a table that shows this. There are draft steps to be taken. There will not be a published document. The end result is going to be some strategy steps and some action steps. There is a draft memo that is currently planned to come from one of the Secretary’s four counselors. The memo will be sent to the heads of the DHHS agencies outlining the working group process and asking them to appoint an individual to participate in the group who is sufficiently high level to make decisions on behalf of the agency. If any CFSAC ex officios are chosen as participants, they will have to be high‐level enough to make decisions. This is a process that is anticipated to include just three to five monthly meetings. There then may action steps to continue. Dr. Lee will chair the group. The action steps will be posted on the CFSAC website. (CFSAC Meeting Minutes, November 9, 2011, p. 49)
This announcement was very promising, although there was one thing missing: stakeholder input. As described, this working group was made up of high level agency representatives who would review current efforts and identify strategy steps, but there was no indication that anyone outside the Department would be consulted or involved.
Seven months passed, and we heard an update on the working group at the June 13, 2012 CFSAC meeting. Dr. Koh said that the ad hoc work group has met twice, chaired by Dr. Lee. The participating agencies are NIH National Institutes of Health (NIH), Centers for Disease Control (CDC), Agency for Healthcare Research and Quality (AHRQ), Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Administration for Children and Families (ACF). At the two meetings, the agencies “put forward accomplishments and opportunities for the future that would begin new efforts and conversations, identify new activities, and try to do the best we can in a very difficult funding environment.” Two preliminary ideas proposed were to have a national webinar on CFS and establish a patient registry, but the conversations are ongoing. Dr. Koh provided no timeline or additional specifics, although he noted, “Getting all these leaders in the department to come to the same table and establish a common agenda is never easy but these two meetings have been productive and we’re going to have more until we have more deliverables to present to you.”
It sounds promising, and is certainly more high level attention on CFS than we’ve had before. But the slow pace and lack of specifics is a bit troubling. In a joint letter to Secretary Sebelius signed by advocacy groups and individuals, advocates requested a meeting with key Department personnel to discuss the community’s concerns and begin to address key priorities, including stakeholder participation in formulation of a cross-department strategy. In the Department’s response, Dr. Lee said that “HHS has convened an Ad Hoc Workgroup on CFS to develop a Department-wide strategy to address CFS and allow active collaboration among agencies. . . . . The next meeting will be held later this summer and include the opportunity to discuss these issues.”
Given the high interest in the activity of this group, and the stated desire by Drs. Koh and Lee to improve communication with the advocacy community, I believe we are entitled to more specifics about this process. On June 25, I requested additional information from Dr. Nancy Lee about the Working Group, including a list of the individuals serving on the Group and minutes of all the Group’s meetings. On July 17, I received the following reply:
We do not plan to release detailed information on the Ad Hoc HHS CFS Workgroup as it is an internal HHS workgroup. The group has been tasked to identify past agency accomplishments and efforts regarding CFS and identify new opportunities for collaboration and coordination in CFS activities. We have no formal minutes of the past meetings. An outcome of the workgroup will be a report that will be posted on the CFSAC website. Because the workgroup is not yet complete in its fact-finding efforts, and because the final report will need to be reviewed by all participating agencies, it will probably not be posted until 2013. (emphasis added)
This is disappointing, to say the least. It is true that documents containing staff advice, opinion and recommendations can be withheld from the public under FOIA. But Drs. Koh and Lee have repeatedly emphasized the need for greater transparency in the work of the Department. Furthermore, in November 2011 Dr. Lee said that the process would involve three to five monthly meetings. Seven months later, we learn that the group has only met twice and the third meeting is planned for later this summer. The impression given at the November 2011 and June 2012 CFSAC meetings was that this group is moving efficiently, if not swiftly, and that the final product of action items would be posted on the CFSAC website. No one established any timeline publicly, nor promised any deadline. Now we know the truth. No details will be released about the work of this group. There will be no stakeholder participation. The final report will not be posted until some time next year.
This Working Group is being presented to us as evidence that HHS agencies are working together to coordinate efforts in a coherent fashion. Much has been made of the requirement for the agency participants to have decision-making authority. But no one should mistake this effort for a strategic plan such as that produced forAlzheimer’s Disease. That plan, which was mandated by Congress, was drafted with input from thousands of stakeholders, including doctors, policy makers, researchers, and patient advocates.
The HHS Working Group will not produce this sort of plan for us, not even close. What we’ve been promised is a report in 2013 that inventories what is currently being done across HHS, and which will hopefully include new initiatives (possibly the national webinar and patient registry). Dr. Koh’s caution about the budgetary climate is, in my opinion, code for “don’t expect anything new that will cost a lot of money.”
It is a sign of small, incremental progress that the Secretary formed this group and that agency representatives will make some sort of coordinated report. Perhaps we’ll finally see a Surgeon General letter like the CFSAC recommended in May 2007 and October 2009. But it is nonsense for the Department to tell advocates that a meeting to discuss a strategic, coordinated and fully-funded plan is not needed because the Department has already undertaken such an effort. This Working Group will not be producing a strategic plan and is unlikely to bring new funding to the table. I don’t appreciate the “don’t call us, we’ll call you” tone adopted by the Department, either.
It’s a bit like addressing America’s hunger problem by giving out Thanksgiving dinners. The effort is needed, but Thanksgiving is just one meal. No one would turn down a free turkey, but no policy maker or anti-hunger activist would claim that the free turkeys solve hunger in America. At least, they wouldn’t make that claim with a straight face.
In our case, this Working Group’s effort is needed but it won’t solve the problem. This disease causes suffering on an epic scale, and there are a multitude of policy, scientific and medical issues that need to be addressed. Patients and their families have developed significant expertise in many of these issues out of necessity. This expertise should be leveraged to the fullest extent possible in order to produce a coordinated, strategic, and fully-funded plan to address all these issues.
I won’t turn down a free turkey, but I see it for what it is: a gesture that is more symbolism than substance.