By Jennifer M. Spotila, J.D.
The Chronic Fatigue Syndrome Advisory Committee (CFSAC) held its second 2011 meeting on November 8 and 9 in Washington, D.C. The CFSAC provides advice and recommendations to the Secretary of Health and Human Services via the Assistant Secretary for Health on issues related to chronic fatigue syndrome (CFS). CFIDS Association President & CEO Kim McCleary and Scientific Director Dr. Suzanne Vernon attended the meeting.
Controversy surrounded this meeting from the day it was announced, as the new Designated Federal Officer, Dr. Nancy Lee, made a number of logistical changes to the meeting. Unlike previous meetings, there was no live videocast and audio-only was available through a call-in number. The location of the meeting was changed from the HHS Humphrey Building to a large room at a Holiday Inn. According to a statement released prior to the meeting, this location change was intended to provide more seating capacity, greater comfort for patients and reduced security requirements. Live videocast was described as too expensive, and patient advocates were left to wonder why money was available for the hotel meeting space but not the live videocast.
Another sign of controversy was a protest organized by advocate Robert Miller and held at the Holiday Inn on the first day of the meeting. Mr. Miller and others wore prison uniforms to symbolize the decades of suffering endured by patients while the federal government has failed to invest adequate resources in CFS research. The advocates handed out information cards about CFS to passersby, and also reached out to journalists such as Llewellyn King of the PBS program White House Chronicle.
Assistant Secretary of Health Dr. Howard Koh briefly attended the meeting and offered comments, as he has at several previous CFSAC meetings. Dr. Koh announced that a new working group on the department’s CFS strategy would be coordinated through his office. He also announced that Chris Williams, formerly of the Agency for Healthcare Research and Quality (AHRQ), had been hired as a special advisor to the department. Dr. Koh described CFS as a critical area and said that this renewed focus was just the beginning. Dr. Lee later stated that this represents a new effort to examine the department’s CFS strategy. A memo to all the agency heads will ask for representatives with decision-making authority to serve on this working group.
Presentations to the CFSAC
The very first presentation at the meeting addressed the contentious topic of how CFS should be classified in the International Classification of Diseases (ICD9-CM and ICD10-CM) used by insurers and other institutions. Donna Pickett, RHIA, MPH, of the National Center for Health Statistics (NCHS), summarized two options currently under consideration. The first option was proposed by the Coalition 4 ME/CFS and would delete CFS from Section R53.8: “Other malaise and fatigue,” and move it to the “Diseases of the Nervous System” chapter under the G93.3 subcode. Myalgic encephalomyelitis (ME) and post-viral fatigue syndrome (PVFS) are already coded under G93.3. The second option, proposed by the NCHS, would create a new subcode under G93.3 to separate ME/PVFS at G93.31from CFS at G93.32. By creating a separate code for CFS, the NHCS is attempting to distinguish between those with viral triggers and those without, as well as retain the data collected under the old code.
Rosaly Correa-de-Araujo, M.D, M.Sc., Ph.D., of the DHHS Office on Disability, gave a detailed presentation on the International Classification of Functioning, Disability and Health (ICF). ICF is the World Health Organization’s framework for measuring health and disability in populations and individuals. The ICF is not used in the United States but the Social Security Administration and Department of Defense are examining its possible applications. No studies of CFS have been done in the ICF context.
CFSAC member Eileen Holderman reported on the review of the CDC’s CFS website by members of the CFSAC and advocate Dr. Lily Chiu. Ms. Holderman described their detailed review of the website, which was then discussed with CDC representatives Dr. Elizabeth Unger and Dr. Ermias Belay. While the information on the website is accurate, CFSAC members felt the tone was disrespectful and the spectrum of information presented was highly selective. They reported that CDC appeared receptive to their concerns, particularly the misuse of information from the website by insurance companies. Drs. Unger and Belay described the process for considering input and making revisions to the website.
CFSAC member Gailen Marshall, M.D., Ph.D., presented on the need for an interdisciplinary approach to CFS research in order to understand overlapping conditions, cofactors and modifiers. While there are biomarkers available in research settings, these same biomarkers cannot be applied in a clinical setting, e.g., natural killer cell function. He advocated for a reverse translational approach wherein clinical observations would inform research, such as in the Rituximab study. In addition, Dr. Marshall recommended that experts convene to detail the clinical presentations of CFS and arrive at evidence-based criteria.
CFSAC member Leonard Jason, Ph.D., presented a summary of work on identifying minimal requirements for research papers. The working group has recommended essential and additional requirements, and a manuscript is in preparation. Consensus around these requirements will greatly improve comparison of results among studies.
Agency Updates from Ex-officio Members
Beth Collins Sharp, Ph.D., R.N., from AHRQ, described a pilot effort called Project Echo examining delivery of care in rural New Mexico to patients infected with Hepatitis C. She also provided information about the National Guidelines Clearinghouse and Innovations Exchange.
Alaine Perry, M.P.H., from the Center for Medicare and Medicaid Services, shared preliminary data on Medicare Parts A and B spending on patients with a primary or secondary diagnosis of CFS. Approximately 300,000 patients were treated in 2010 at a cost of $100 million.
Dr. Teresa Michele from the Food and Drug Administration updated the committee on the reassignment of all CFS drug applications to the Division of Pulmonary, Allergy, and Rheumatology Products in order to conduct a more coordinated and consistent review process. A separate effort to develop clinical end points and acceptable outcome measures should also facilitate the conduct and review of clinical trials.
Dr. Belay provided an update on CDC activities since the May 2011 CFSAC meeting, including attendance at conferences, research publications and meetings with advocacy groups. Dr. Belay indicated that the Wichita data set is now available and that data is being collected to inform the revision of the case definition.
Dr. Deborah Willis-Fillinger provided an update from the Health Resources and Services Administration focused on health access and learning community grants.
Michele Schaefer from the Social Security Administration provided data on 2008 applications for Social Security benefits related to CFS.
Dr. Janine Austin Clayton, acting director of the Office of Research on Women’s Health at NIH, provided an update on leadership transition. She has been appointed to replace the recently retired Dr. Vivian Pinn while a national search is conducted, and Dr. Charles Wells is replacing Dr. Dennis Mangan as chair of the Trans-NIH ME/CFS Research Working Group. Dr. Wells summarized recent activity at NIH and stated that the program announcement for research funding would be reissued in early 2012, although this does not include any funding set aside for CFS research. Dr. Cheryl Kitt reported that very few CFS research applications are submitted to the CFS Special Emphasis Panel, approximately six to 18 applications per study section. CFSAC members urged NIH to examine possible barriers to submission and stated that the lack of funding likely contributes to the low application rate.
CFSAC members discussed and voted upon recommendations, with wording to be finalized after the meeting. All recommendations passed unanimously:
- CFSAC believes Option 1 [i.e., the proposal from the Coalition 4 ME/CFS] is the best option for ICD-10 and rejects option 2. CFS should be moved to G93.3 and stay within the ME classification.
- CFSAC encourages the new HHS interagency working group to focus on the mission of physical/virtual Centers of Excellence and pulling together resources across the agencies to create programs to deliver better care to patients.
- CFSAC recommends that NIH issue a Request for Applications focused on clinical trials.
- CFSAC recommends clarification of the process and pathway of its own recommendations to the Secretary and back, and that the process be articulated for transparency.
Three members of the CFSAC have terms that expire in April 2012. Dr. Chris Snell, Dr. Nancy Klimas and Dr. Leonard Jason made brief farewell comments, and CFSAC and audience members thanked all three for their service.
During three hours of public testimony, comments were provided by Chris Williams, Mary Dimmock, Anonymous, Andrew Volkelman, Mary Schweitzer, Pat Fero, Toby Vokal (read over the phone by Tina Tidmore), Nancy Richardson, Beth Skipper (read by Lori Kroger), Kim McCleary, Joan Lilletto, Janice Smith, Ken Friedman, Gabby Klein, Robert Miller, Jennifer Spotila, Denise Lopez-Majano on behalf of her son, Melanie Pruitt, Barbara Catone, Denise Lopez-Majano, Charlotte von Salis, Joseph Lanson, Mike Munoz (read by Marly Silverman), Marly Silverman and Betina Nickelson.
Jennifer M. Spotila, J.D., is a previous member of the Solve ME/CFS Initiative ’s Board of Directors. Ms. Spotila participated in the CFSAC meeting via the live audiocast.May 9, 2013