Advocacy Alert: 5/07/2009
May 2009 CFIDSLink: CDC Solicits Input and Gets Plenty
From the May 2009 Edition of CFIDSLink
Web version available at http://www.cfids.org/cfidslink/2009/050607.asp
CDC Solicits Input and Gets Plenty
The CFS research program at the U.S. Centers for Disease Control & Prevention (CDC) is almost 25 years old. Its home in the Coordinating Centers for Infectious Diseases, under a unit called the Chronic Viral Diseases Branch (CVDB) suggests that CDC defines CFS as a condition resulting from a chronic viral infection and that its research program is designed to understand it as such. Yet the most recent studies from CDC investigators link CFS to traumatic events in early life and repeat others' findings of poor sleep in CFS. A quarter of a decade after the first investigation of CFS by CDC in Incline Village, Nevada, the CVDB's lack of understanding of "true" CFS could not be more obvious. Here is a meeting report, as well as some information you won't find elsewhere - how the Association has been pushing this point for nearly two years.
A public meeting held at CDC on Monday, April 27, 2009 invited "stakeholder" input on a five-year strategic research plan being developed to guide the CFS program. The heightened alert caused by rising numbers of swine flu (H1N1 virus) in the U.S. put CDC on the front lines of that outbreak and its Global Communications Center was swamped by reporters, video crews and photographers at noon on April 27. A press briefing being held in auditorium B-1 garnered most of the traffic, but a few of us walked farther down the hall to B-2 where the CFS meeting was held. There were about 30 people in the room, nearly half of whom were CDC employees. The advocates were mostly local patients, with just a few of us having traveled from out of state to attend the half-day meeting. CFS patient Alyson Butcher and her husband Kenny flew in from Houston that morning and Dr. Nancy Klimas was there from Miami. I had driven from Charlotte the night before.
Acting CDC director Dr. Richard Besser had planned to make opening comments, but on arrival we were told that he, of course, had to change his schedule to accommodate media interviews about the swine flu outbreak. Dr. Lonnie King filled in, recounting worn CDC messages and offering the story of "one of their own" agency employees who came forward as a CFS patient after the November 3, 2006 press conference led by then-CDC director Dr. Julie Gerberding. Dr. Steve Monroe provided an overview of the planning process and gave an update on the agency's full-force efforts to respond to the "public health emergency" caused by swine flu, of which there were then 20 U.S. cases. Dr. William Reeves, chief of CVDB and CDC's lead CFS researcher, gave a short and overly general synopsis of current activities. The moderator then provided ground rules to the public for making comments, both in person and by telephone, which those of us in the auditorium could hear broadcast over the P.A. system.
The lack of detail about CDC's research plan before the April 27 session left many to use their time to plead broadly for help with better diagnostics and treatment, or access to physicians who would recognize the severity of their symptoms and offer some relief. Others expressed strong emotions about the lack of progress over 25 years and deep concern about CDC's propagation of a broader "empiric" classification method for identifying CFS patients enrolled in its studies. Tempers often flared about the lack of respect shown by Dr. Reeves and others for patients' concerns and the lack of productivity and direction that defined CDC's CFS research in recent years. Several people demanded new program leadership and others stated outright that Reeves should be replaced.
By 5:00, about 35 people had offered their input and three of the four CDC leadership representatives (Sarah Wiley, Dr. Monroe and Dr. Michael Miller) were still attentive, making notations in their green lab notebooks and ignoring their Blackberries and cell phones, in spite of swine flu updates likely being issued to CDC staff. But Reeves, seated on the first row with his head bowed, glasses off and eyes closed, remained still through the lengthy comment period. Was he even listening? He vanished as soon as closing remarks were delivered by Dr. Monroe.
Three Association representatives delivered comments during the testimony period: board chairman Jennie Spotila, board member Dr. Katrina Berne and me. We had written our comments independently but they all echoed messages the Association had been delivering for the past 20 months to CDC leadership. The program was broken, or as I chose to say from the podium that afternoon, it had "lost its mojo."
Our most recent concerns were first directly expressed in 2007 through the decision not to pursue a sole source contract offered by CDC to continue the provider education project. While the need for provider education is urgent, CDC's methods were inefficient and the contract terms were unfavorable. In a letter sent to contract officer Jeff Miller on August 16, 2007, I stated, "the many potential risks and vulnerabilities in the terms of this contract, as well as growing concerns about the direction of the CFS program and the manner in which the contracting process has been handled, have led to the decision not to continue the proposal process."
Conversations with coordinating center leadership went nowhere and a Blue Ribbon Panel's set of recommendations didn't go much farther in changing current practices. So, we asked for a Congressional inquiry into program direction and funding accountability through a letter sent to Senate Majority Leader Harry Reid and other influential members of Senate and House in March 2008:
"Senator Reid, we deeply appreciate your tireless advocacy in support of the CFS patient community and we know that you are committed to assisting us in fulfilling the promise of better diagnostics and therapeutic approaches to reduce the significant burden of illness posed by CFS. Your immediate assistance in helping us determine the state of the CFS program at CDC and restore its promise would be incredibly important and hopefully will lead to improved transparency, accountability and performance."
Senator Reid forwarded our letter to then-CDC director Dr. Julie Gerberding and she responded with a promise to look into the matter. A meeting held in Senator Reid's office on June 7, 2008 with Miller, Monroe, Wiley and two DC-based CDC staffers gave us the opportunity to directly state our concerns and to ask some of the questions the Association had submitted in response to a written update circulated by CDC at the May 2008 CFS Advisory Committee meeting. They promised regular updates and a complete accounting of the CDC's expenditures between 2005-2008."
A series of conference calls over the 2008 summer and into early fall continued the dialogue and provided additional opportunities to continuously reinforce our message about the need for reforming the program. We closely examined the expenditures CDC reported and were given descriptions of the activities supported, although CDC staff didn't seem concerned by the lack of outcomes for the millions that had been spent and obligated to the program. At the October 2008 CFS Advisory Committee meeting, I went "public" with these concerns and advisory committee members recorded theirs as well.
As scheduled, two weeks later CDC convened a long-overdue external peer review of its program. The participants were selected from lists of candidates submitted by the Association, the CFSAC and others earlier that spring; however, only five reviewers were chosen and one was unable to attend. Based solely on the report issued after the review, material presented to them must have focused on past work over a 10-year period since the prior peer review in 1999, rather than more recent past or planned studies. This surprisingly positive endorsement of CDC's program was used by CDC to inoculate other criticism, and at that point, the focus shifted to developing a five-year plan, as the reviewers recommended.
The November 2008 election brought opportunities to engage new leaders in the dialogue, but delays in confirming a new Secretary of Health that meant a new CDC director might not be appointed for months after the election. Early in the new administration, the Association sent a letter to Monroe on February 10 citing President Obama's directive to enhance data sharing and transparency:
"The data amassed by the CDC CFS Research program is a valuable resource that must be released and shared in accordance with the CDC/ATSDR Policy on Releasing and Sharing Data and the President's memorandum dated January 21, 2009 that directs all executive agencies to 'take appropriate action, consistent with law and policy, to disclose information rapidly in forms that the public can readily find and use.' By releasing the data in accordance with these policies, you are ensuring it will be used to its full potential, that work is not duplicated, and that funds are not spent unnecessarily"
While waiting for the dust to settle after Senator Daschle withdrew from consideration as Secretary of Health, on March 11, 2009 the Association sent a heavily footnoted seven-page memo to acting CDC director Dr. Besser, describing the history of CDC's engagement in CFS research and our recommendations for corrective measures.
"...progress toward understanding CFS as a chronic condition with multiple triggering and perpetuating factors has stalled and the lack of program staff's experience in dealing with chronic conditions, particularly in establishing and maintaining the type and variety of partnerships and collaborations recognized as being critical to the study of chronic conditions, is undoubtedly one of the essential elements currently missing from the agency's approach to CFS."
We also provided this information to Congressional appropriators and shared concerns that CDC was developing its five-year plan without including a process for obtaining stakeholder input. (Dr. Besser responded on April 22, conveying his assurances that CDC is "committed to supporting a rigorous research program on CFS and to address the requests and concerns of your organization and others.")
A month after receiving our memo to Dr. Besser, the April 27 meeting was announced. The lack of a planning document to examine and respond to left us feeling that the meeting was likely to erupt into a full-blown "gripe" session, especially with the immediate frustration expressed by advocates for the late notice of the date, lack of accessibility, and absence of an agenda and a report draft. We asked CDC leaders to broaden access and helped circulate notices to encourage participation, hoping that CDC would hear from a broad segment of its constituency. The meeting date was also the deadline for one of the NIH mechanisms to apply for funds available under the Recovery Act, so we knew this would limit participation from the scientific community, but hoped they might respond if the deadline was extended. CDC accepted input until May 1, 2009.
All our predictions about the public meeting turned out to be accurate, as others' published accounts of the meeting document. In my 18 years with the Association, I can't recall another occasion on which the patient community was so consistent in its call for change. I'm sure many observers assume it was the result of a tightly controlled campaign of message reinforcement. I suppose that is preferable to believing that all these people reached the same conclusion independently, which is what really happened on that day.
CDC has agreed to release its draft plan on May 27 at the CFS Advisory Committee meeting and on its web site. It will accept public comment on the draft plan through June 30. We continue to encourage all persons interested in the future of CDC's research on CFS to express their views and offer input into the plan. As taxpayers and advocates, it is our responsibility to see that these funds are put to the best possible use to discover ways of objectively diagnosing and effectively treating CFS.
President & CEO
The CFIDS Association of America
May 5, 2009
Links to other reports on the April 27, 2009 meeting:
Cort Johnson's About ME/CFS blog:
Hillary Johnson's Osler's Web blog:
Craig Maupin's CFS Report blog: