Dr. Christopher Snell and Dr. Wanda Jones

CFS Advisory Committee Meets with New Members, New Chair, Compressed Agenda

The federal CFS Advisory Committee met on May 10, 2010, for its 17th semi-annual meeting since being chartered in 2003. The meeting was videocast live and the recording has been archived for reference. For the past several years the committee has met for two days; however, this meeting was compressed to one day. The designated federal officer for the committee, Dr. Wanda Jones, explained this was necessary due to constraints of time and budget, to ensure that the practice of meeting every sixth months continued.

Dr. Howard Koh

All voting members of the committee were present, including five new members welcomed by the new committee chairman, Dr. Christopher Snell of University of Pacific. The new members had been appointed following a thorough process that involved reviewing nominations received from the public, screening for conflicts of interest and vetting through the Department of Health and Human Services (DHHS). The five new members were sworn in prior to the meeting by Assistant Secretary of Health Dr. Howard Koh, who attended the first segment of the meeting, offered opening comments and took questions from members of the committee.

A presentation by Elizabeth Unger, M.D., acting chief of the Centers for Disease Control and Prevention’s Chronic Viral Diseases Branch where the CFS research program is housed, was the only formal update provided by federal ex-officio members of the committee. This was the first meeting since the leadership transition of the CFS program following Dr. William Reeves’ reassignment on February 14, 2010. The committee greeted Dr. Unger warmly and relatively few questions were asked about the nature or direction of CDC efforts under her leadership. A rather obvious omission was from the report and Q&A was the CDC's studies of XMRV in CFS, being conducted by a group in the National Center for HIV/AIDS, Viral Hepatitis, STD and TB prevention.

Dr. Jerry Holmberg of the DHHS Office of Public Health and Science and senior advisor for blood safety, gave a much-anticipated update on blood safety issues. Dr. Holmberg had addressed the committee on October 30, 2009, to announce the Department’s efforts to understand the impact of the report of XMRV in CFS patients and healthy controls as it related to the nation’s blood supply. At the May 10 meeting, he described progress of laboratory efforts to standardize tests for XMRV that could be used for large-scale screening and of a second group looking at the blood donor education and communications that was convened by the AABB, but included several federal agency representatives. The second group’s activities were recently informed by three countries’ decisions to indefinitely defer individuals who volunteer information about present or past CFS diagnosis. Members of the CFSAC questioned Dr. Holmberg closely and continued discussion about these issues after his presentation ended.

CFSAC committee

Public testimony was limited to 30 minutes due to the compressed schedule; however, Dr. Snell requested that the committee extend its session until 4:15 p.m. to accommodate the addition of 15 more minutes of statements from the public. Dr. Jones explained the process that had been used (random selection of names from a hat) to choose the witnesses allotted time, since the meeting format dictated a shorter session and more requests were received than usual. Nine individuals were invited to address the committee for three minutes each and most of the testimony focused on the topic of the committee’s charter as had been requested. The nine individuals who spoke before the committee were: John Herd, Kim McCleary (president & CEO of the CFIDS Association of America), Robert Miller, Mary Schweitzer, PhD, Joan Grobstein, MD, Nancy McGrory, Annette Whittemore (founder and CEO of the Whittemore Peterson Institute); Fred Friedberg, PhD (president of the IACFS/ME) and Pat Sonnett. Seventy members of the public submitted written testimony of up to five pages each for the record. (Written testimony submitted by Kim McCleary on behalf of the CFIDS Association of America can be read here.)

Dr. Mike Houghton

The bulk of the committee’s time was spent discussing the committee’s charter, scheduled to expire on September 5, 2010. Dr. Jones and Dr. Koh both emphasized the Department’s unequivocal intention to renew the charter, so the committee’s dialogue was intended to recommend changes that would strengthen the committee itself and formalize certain practices (like videocasting and reserving time for public comment). Two subcommittees (research and education/quality of life) formed by members of the full committee and ex-officio representatives met over lunch and presented recommendations during the afternoon session.

As the committee concluded its work, it recognized the service of member Jason Newfield, Esq., whose term would be expiring before the fall meeting. His replacement, attorney Steve Krafchick, who had been appointed but not yet sworn in, was also in attendance to ease transition. Dr. Snell requested that all committee members review the past recommendations and prioritize them for further consideration at the next meeting. The meeting was adjourned at 4:10 p.m.

News Shared During the Meeting (name reflects source of announcement):

CFSAC meeting sign

• The committee’s charter will be renewed prior to its expiration on September 5, 2010. (Dr. Wanda Jones and Dr. Howard Koh)
• A draft of a new charter reflects the addition of a representative from the Agency for Healthcare Research and Quality (AHRQ) and Christine Williams, director for Strategic Partnership for AHRQ, was seated at the committee table in an advisory capacity. (Dr. Wanda Jones) (The draft charter was not made available to the public in attendance at the meeting. It is expected to be posted to the CFSAC website during the week of May 17.)
• The committee will adopt a less formal set of by-laws to document its practices with regard to subcommittee structure, meeting format, means of soliciting public testimony, etc. (Dr. Wanda Jones.)
• The National Institutes of Health (NIH) will co-sponsor the First International XMRV Workshop in September 2010 on the NIH campus. (Dr. Howard Koh, Dr. Wanda Jones, Dr. Eleanor Hanna and Dr. Jerry Holmberg)
• The NIH will sponsor a “State of the Knowledge” meeting on CFS in 2011. (Dr. Howard Koh, Dr. Wanda Jones and Dr. Eleanor Hanna)
• The Secretary and Assistant Secretary of Health are committed to improved communication with the CFSAC, particularly with regard to the status of and decisions about recommendations sent to the Secretary. (Dr. Howard Koh and Dr. Wanda Jones)
• Stopping the live webcast of CFSAC meetings is not an option to reduce the expense of convening the committee to stay within the annual budgeted amount of $130,000. (Dr. Wanda Jones)
• The CFSAC may hold its next meeting in conjunction with the XMRV Workshop in September 2010. (Dr. Wanda Jones)
• Plans are being made to avoid the loss of important institutional memory by staggering members’ terms. (Dr. Wanda Jones and Dr. Christopher Snell)
• Nominations to advisory committees take an average of 275 days to process, although the new CFSAC members were cleared within approximately 100 days. (Dr. Wanda Jones)
• The Agency for Healthcare Research and Quality (AHRQ) has two networks to integrate research and primary care. Studies can be funded by AHRQ through these networks that involve large health care delivery system partners like Kaiser and WellPoint, through task orders, contracts and grants, depending on the nature of the study. (Dr. Christine Williams)
• The Heath Resources and Services Administration (HRSA) has funding announcements to promote collaboratives quality improvement in health care delivery and comparative effectiveness research (CER.) These initiatives could be applied to CFS. (Dr. Deborah Willis-Fillinger)

Report by Dr. Elizabeth Unger, Centers for Disease Control & Prevention (CDC)

Dr. Beth Unger

• CDC will use the five-year plan for its CFS program as a guideline and “living document.”
• CDC’s three large field studies are concluding the data collection phase.
• CDC is committed to improved communication and more collaboration with the CFSAC.
• CDC intends to make its data available through a new center at CDC being created to manage datasets across the agency.
• The empiric definition is being examined by CDC, especially cut-off points for various instruments, and a conference may be convened to appropriately review it.
• The pilot registry for unexplained fatiguing illness, involving 828 health care providers in Bibb County, Georgia, is being reviewed for its cost-effectiveness as a means of identifying CFS patients and enrolling individuals for further study.
• A process is under way to fill the branch chief position occupied on an “acting” basis by Dr. Unger.
• CDC is interested in identifying biological measures that will help identify subgroups of CFS. Various challenges (exercise, stress) may help reveal these measures more readily than simply looking at CFS in a static state.
• Transition issues delayed planning for an international workshop at CDC. Data from the Georgia surveillance study will be available and convening a meeting about this data in FY2011 is part of the current planning process.

Report by Dr. Jerry Holmberg, Office of Public Health and Science

Dr. Jerry Holmberg

• Major activities of the Department-led efforts to ensure the safety of the blood supply with respect to XMRV:
  • Establish a reliable method of detecting XMRV;
  • Assess the risk to the blood supply; and
  • Manage any risk to the blood supply.
• Two committees have been meeting regularly since his October 2009 report to the CFSAC:
  • Blood XMRV Scientific Research Working Group
  • AABB Interorganizational Task Force on XMRV
• Six laboratories (CDC, two from FDA, NCI, Whittemore Peterson Institute and Blood Services Research Institute) are engaged in studying analytical panels of XMRV to standardize methods for detecting XMRV. Panels were sent to the labs in March. Problems with some IRBs have delayed results, but they are expected in June 2010. Two individuals will break the code to see if the results are accurate across all participating labs.
• A clinical panel of 25 XMRV-positive CFS patient samples, 250 samples from blood donors in Reno and 25 controls will be studied next.
• There has been discussion about an epidemiology study of transfusion-related transmission of XMRV, once detection methods are standardized. There is little data about the risk of prostate cancer or CFS following blood transfusion and these few studies (including one of Dr. David Bell’s Lyndonville CFS patients) provide scant evidence of either prostate cancer or CFS following blood transfusion.
• The AABB Task Force is evaluating the safeguards in place and questions about health that are asked of potential blood donors through the Unified Donor Questionnaire.
• The three countries that have recently changed their policies for donors with CFS rely on the volunteering of information about past/present CFS diagnosis; none have included questions or other screening processes to identify CFS donors who do not volunteer this information. The AABB Task Force is working proactively to recommend how to best address this issue in U.S. blood centers and will not wait for a definitive answer about XMRV in CFS. The blood supply is not federalized and the U.S. Public Health Service relies on collaboration with community blood centers and the Red Cross to institute new recommendations and policies.
• Research is being conducted to develop a “pathogen reduction agent” that could be added to blood in the future to mitigate risk of emerging agents like XMRV, but this is something that will take time. For now, “we know XMRV exists and that it is likely transmitted by blood, but we don’t yet know if it causes disease.”

Recommendations Forwarded to the Secretary and Assistant Secretary by the CFSAC*:

Dr. Leonard Jason

• Given concerns for patient health, that government and non-government organizations responsible for the US blood supply indefinitely defer individuals with a current or past history of CFS from donating blood;
• That the Secretary recognize the special challenges of ensuring CFS is part of any efforts to train and educate health care professionals under health care reform;
• That AHRQ, HRSA and the Centers for Medicare and Medicaid (CMS) be directed to develop private and/or public demonstration grants for health service paradigms that result in more effective, efficient care and better health outcomes for individuals with CFS;
• That any attempt to classify CFS as a psychiatric disorder in revisions of the International Classification of Diseases (ICD) be vehemently opposed; and,
• That the addition of third CFSAC meeting by webinar or webcast be fully explored for 2011.

The CFSAC also made the following recommendations about the charter and by-laws:

• Add ex-officio representatives from these operating divisions of the Department (in addition to the stated expansion to include AHRQ)—Centers for Medicare and Medicaid (CMS);
• Add liaison members from the following Departments of the Executive branch: Department of Defense, Department of Labor, Veterans Affairs;
• Require that webcasting and archived recordings of the meetings continue to be made available to the public;
• Reserve one hour per meeting day for testimony from the public with a minimum of 5 minutes per individual;
• Explore means of allowing members of the public to ask or submit questions to enhance dialogue with the public at the meeting;
• Add “etiology and biomarkers” and “improve the quality of life of persons with CFS” to the statement of the committee’s function in the charter;
• Require that the committee chair (and subcommittee chairs) have input into meeting agendas;
• Require that following each meeting, there be direct communication between the chairman and the Assistant Secretary of Health regarding the recommendations; and,
• Require that the Assistant Secretary of Health provide feedback about the recommendations to the committee in a timely manner.

* The wording of recommendations is compiled from notes taken during the meeting. The committee regularly works after the meeting to refine the language of the recommendations. The CFSAC website publishes a list of the final recommendations, although this generally takes several weeks to be posted.

In Attendance at the Meeting:

Voting Members of the Committee (Appointed by the Secretary of Health):
Christopher Snell, PhD
University of Pacific

Dane B. Cook, PhD
University of Wisconsin-Madison

Ronald Glaser, PhD
Ohio State University

Arthur J. Hartz, MD, PhD
University of Utah

Eileen Holderman
Galveston, TX

Michael Houghton, PhD
University of Alberta

Leonard Jason, PhD
DePaul University

Nancy Klimas, MD
University of Miami

Susan M. Levine, MD
New York, NY

Gailen Marshall Jr., MD, PhD
University of Mississippi

Jason Newfield, Esq.
Garden City, NJ

Steve Krafchick, Esq. (term begins July 2010)
Seattle, WA

Ex-Officio Members of the Committee:
Wanda K. Jones, DrPH, Office of Public Health and Science, DHHS (Designated Federal Officer)
Marc W. Cavaille-Coll, MD, PhD, Food and Drug Administration
Eleanor Z. Hanna, PhD, NIH
J. Michael Miller, PhD, CDC
Mike O’Connor of Social Security Administration
Kevin Parker, Social Security Administration (substitute for Cheryl Williams)
Christine Williams, AHRQ (advisory capacity)
Deborah Willis-Fillinger, MD, HRSA

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