Frequently Asked Questions About the CFIDS Association of America
RESEARCH
ADVOCACY
EDUCATION AND COMMUNICATION
STRUCTURE AND FUNDING
RESEARCH
What are the Association’s priorities for its research program and research funding?
In November 2007, the Association announced a major expansion of its internal research capacity when systems biologist Dr. Suzanne Vernon joined our staff as scientific director. Our board of directors evaluated our strategic direction and established a new focus for our research program: to build, support and link a critical mass of innovative and credible researchers focused on early detection, objective diagnosis and effective treatment and to create, identify and leverage new private and federal funding sources and opportunities for CFS investigators.
In March 2008, we issued a request for applications and reviewed 24 responses from research groups around the world for scientific and strategic merit. We announced funding for six innovative studies in November 2008 and in January 2009 we initiated the first formal CFS research network. The network established a stronger foundation with the Banbury meeting held in partnership with the National Institutes of Health (NIH) in September 2009. We’re now working with the Biomedical Informatics Research Network an NIH-sponsored initiative, to develop the infrastructure to support the participation of multiple sites and investigators in pooling data and developing best practices and standard operating procedures to bring greater cohesion to the field of CFS research. We have also joined the Genetic Alliance, a coalition of more than 600 disease advocacy organizations. We now have access to its resources that enable advocacy organizations to be more effective research-support organizations.
To expand the pool of funds available to support CFS research, in 2009 we responded to federal funding opportunities made available under the American Recovery and Reinvestment Act (ARRA). Competition for these funds is fierce, with some announcements drawing up to 10 times as many applicants as awards. We haven’t been successful yet, but we have additional proposals under development and will resubmit some of the earlier applications with enhancements suggested by the reviewers.
On March 29, 2010, we announced the launch of a unique research resource, the SolveCFS BioBank. Our first collaborations are beginning and General Enrollment Criteria enable the broad participation by patients diagnosed with CFS by a physician, while ensuring that the population can be narrowed according to criteria for individual studies approved by our Medical Research Advisory Committee. Consistent collection of detailed clinical data and health history will be a tremendous resource for the field, in addition to the tissue repository. See our BioBank FAQ for additional info about current studies.
With these activities under way and the promising XMRV discovery, there has never been greater potential for accelerated progress in CFS research. In the spring of 2011, we will be issuing a new Request for Applications, a Scientific Advisory Board and expansion of the Solve CFS BioBank.
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Does the Association support use of the Canadian Clinical Definition for ME/CFS (CCD) published in 2003 by Carruthers, et al.?
The short answer is yes. We believe the issue of the case definition is extremely important and that it must be revisted for research and clinical applications.
It should be noted that the CCD was published in the Journal of Chronic Fatigue Syndrome (JCFS), which was never linked to medical indexes like PubMed or MedLine. JCFS is no longer in print. Therefore, this article did not become part of the mainstream medical literature and has received scant attention outside the relatively small field of CFS experts. There has been some discussion among its authors to seek publication in a journal with wider circulation; however, its length, 30+ pages, makes this proposition challenging.
On April 14, 2010, the Association invited Dr. Leonard Jason of DePaul University to deliver a webinar program on the various CFS definitions and their impact on research and care. During that program, he stated that there is an important need to standardize the Canadian criteria and to validate those criteria. He provided an example of how many different ways the cardinal symptom of “post-exertion relapse/fatigue/malaise” might be queried about and documented by different clinicians/researchers. It is also important to note that many of the lab measures that might be used to operationalize categories of symptoms like “immune” are not clinically available, such as tests of NK cell cytotoxicity, which can only be reliably obtained from selected university research labs. Similarly, imaging tests, sleep studies, tilt tests, etc., are conducted at centers worldwide using different equipment and different protocols. Comparing results of those tests is not as straightforward as it might seem on the surface. Making specific results from such tests mandatory for diagnosis or inclusion in a study presents important challenges and raises costs in a field that is grossly underfunded. And for individuals seeking diagnosis, access to and cost of extensive testing measures are important considerations. Dr. Jason's group published a paper proposing revised Canadian criteria in July 2010 in the American Journal of Biochemistry and Biotechnology.
The current general enrollment criteria for the SolveCFS BioBank enables patients diagnosed by a physician using either the CCD or the 1994 Fukuda definition to participate, although all patients must have post-exertion malaise even though it is not required under the Fukuda definition. The Association also recommended that the American Psychiatric Association take note of the CCD in its written comments submitted on April 1, 2010 in response to feedback on the DSM-5 proposal.
The CFIDS Association consulted with Dr. Jason to ensure that the clinical questionnaires used for the SolveCFS BioBank will collect meaningful data that can be used to help overcome some of the definition issues that are huge challenges to the field. Having an established research network (as the Association does) and this biobank of blood/tissue samples AND extensive patient clinical information will be an enormous tool for the field and we hope the patient and scientific communities will support it.
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Did the CFIDS Association deny research funding to the Whittemore Peterson Institute for XMRV research?
Like most grantmaking organizations, our research policies preclude us from disclosing details about studies that were not approved for funding. This preserves the applicant’s ability to submit the study to another institution or to revise and resubmit on another round. It is possible to state that at the time of the Association’s March 2008 Request for Applications there were no applications on the topic of XMRV and CFS.
In the spring 2011, a new funding opportunity will be announced and applications from WPI and other institutions studying XMRV will be welcome, subject to the same eligibility criteria for all applications.
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What is the Association doing to foster research on XMRV?
Since Oct. 8, 2009 when the first report linking XMRV and CFS was published in Science, the Association offered its sincere congratulations to the Whittemore Peterson Institute, referring to the discovery as “landmark” and “game-changing.” Our scientific director, Dr. Suzanne Vernon, began immediately fielding inquiries from researchers interested in pursuing this promising research, linking laboratory researchers with qualified CFS-expert clinicians. We emphasized the need for true replication studies to repeat both the laboratory methods and the patient selection used in the Science study, although this information is still not readily available to other groups based on the publication, its supplement and information on the WPI website. Early on, the Association was criticized for placing emphasis on the characteristics of the CFS patients and healthy controls included in the WPI cohort. The absolute importance of the selection criteria has since been reinforced in presentations made by experts including retrovirus experts Dr. John Coffin and Dr. Joseph DiRisi study author and pioneering clinician Dr. Daniel Peterson, and clinical researchers Drs. Nancy Klimas and Lucinda Bateman. Now, with recent reports from U.K., Dutch and CDC researchers who failed to find evidence of XMRV in their patient cohorts, the various methods of selecting CFS patients has come into sharp focus.
Suzanne has been appointed to the Department of Health and Human Services Blood XMRV Scientific Research Working Group and CEO Kim McCleary serves an expert on the AABB (formerly the American Association of Blood Banking) Interorganizational Task Force on XMRV. We have worked with these committees to issue and distribute regular and timely updates, including hosting a Dec. 17, 2010 webinar about the Phase 1 and 2 outcomes of the Blood Safety study. The Association is also collaborating with several groups studying XMRV and conducting replication studies. These collaborations have taken various forms, from providing consultation on CFS (since many of the researchers engaged in these studies are new to CFS research), to linking bench researchers with sources of clinical samples.
The Association has catalogued evolving news about XMRV, regularly providing analysis to explain the significance of new developments. In an environment marked by multiple competing interests and ample rumor and speculation, the Association has tried to steer a steady course to provide the patient community with solid information. We sought immediate guidance from the National Cancer Institute, a collaborator on the Science study, about precautions CFS patients should take, and we assembled recommendations from experts on the delicate issue of commercial testing for XMRV.
We issued a press release following the June 2010 AABB recommendation about blood donation by CFS patients. We regularly update our XMRV resources page and send out “breaking news” through various traditional and social media communications channels. As new information becomes available, we will assess each new development on its own merits and present an informed viewpoint. Some of the developments may be disappointing, but only rigorous science will advance true understanding of the cause of and treatments and cure for CFS. Presently the United States is the only country that asks blood donors about a current or past history of CFS as a means to defer them from donating. Other countries that have implemented "bans" on CFS patients donating blood do not screen for the diagnosis.
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What is scientific director Suzanne Vernon’s position on the 2005 empiric case definition?
"While I was at CDC, I helped organize a series of meetings over a period of three years that included many of the world’s leading CFS research and clinical investigators. The purpose was to clarify and optimize the 1994 case definition criteria. At each meeting, after a series of presentations we would break into groups and tackle various aspects of the case definition: for example, generating a comprehensive list of medical and psychiatric exclusionary conditions and selecting validated instruments to measure the severity, duration and occurrence of fatigue, pain, etc. These meetings resulted in the open access publication titled, Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution. This publication and the list of authors who participated in these case definition meetings is posted at: http://www.ncbi.nlm.nih.gov/pubmed/14702202.
"In 2005, the CDC CFS group used a set of standardized instruments (recommended by the international group above) to measure the severity of three major domains described by the 1994 CFS case definition, namely physical function and disability (measured with the SF36), physical and mental fatigue (measured with the Multidimensional Fatigue Inventory) and symptoms (measured with a 19-item scale called the CDC symptom inventory). These three standardized instruments were applied to the Wichita Clinical dataset. The resulting paper is posted at: http://www.ncbi.nlm.nih.gov/pubmed/16356178. The major finding was that patients diagnosed with CFS using the 1994 criteria in the four previous years of being studied did not necessarily meet the 1994 criteria for the clinical study when evaluated with these three instruments. This study demonstrated the waxing and waning nature of CFS symptom severity and illustrated how severely ill patients could be identified in a standardized way using these instruments.
"For this study, the subscales and the cutoffs were determined empirically using mathematical (Monte Carlo methodology) and statistical (chi square and cluster) approaches applied to the entire Wichita Clinical dataset. In retrospect, other approaches should have been tested including incorporation of additional subscales into the algorithm and adjusting cutoffs.
"I support systematic application of standardized instruments to assess severity of CFS symptom domains and this is the approach we (the CFIDS Association) are using with our funded investigators and the SolveCFS Biobank. Symptom domain severity (e.g., sleep disturbance, pain, cognition) can be used to subgroup patients and identify biomarkers. Because CFS defined in the general population is known to be different than CFS diagnosed by physicians, I do not believe the empiric criteria as described in the 2005 paper should be used in research. Any empiric algorithm must be optimized and then validated by other independent investigators, just as any other biomarker or classification would have to be in order to be accepted. Finally, the major CFS funding organizations, including the NIH and the CFIDS Association, accept research applications that use the 1994 CFS case definition criteria and the Canadian consensus criteria, and in all cases, require that the means of patient (and control) selection be appropriately described." – Suzanne D. Vernon, PhD, scientific director of the CFIDS Association of America.
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ADVOCACY
What is the Association doing to combat the changes to the DSM-5 manual that affect CFS?
The proposed DSM changes (www.dsm5.org) were posted on Feb. 9, 2010 and the public was invited to comment through April 20, 2010. Rather than act hastily, we worked to understand all the factors involved with these proposals and how to most effectively influence the final decisions. We have a tradition of being deliberate and thorough in our actions that we will uphold. We consulted with professionals who have expertise in the processes employed by the American Psychiatric Association and World Health Organization to institute changes that affect ICD coding and clinical care. On April 1, 2010 we submitted a detailed set of comments and an urgent recommendation to abandon the proposal to create a new category of mental disorders called Complex Somatic Symptoms Disorder (CSSD). The latest proposed revisions will be published Aug. - Sept. 2011..
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What is the Association’s position on the CFS research program at CDC? Do you support the CDC’s empirical definition of CFS?
The Association has been very public in its criticism of the CFS Research Program at CDC. You can read a summary of our recent efforts. The Association does not support use of the CDC’s empirical definition of CFS in federally funded research and has repeatedly urged that CDC discontinue selecting CFS cases for its studies using these guidelines. The Association has never funded any research based on the empiric definition, nor has any education supported by the Association been based on the empiric definition. Review the Association’s applicant research guidelines for defining cases and its current eligibility criteria for the BioBank.
The Dec. 17, 2010 announcement by CDC that the CFS Research Program will be led by Elizabeth Unger, MD, creates the possibility for expanded opportunities for collaboration and progress toward shared goals. However, we will continue to insist upon rigorously conducted CFS research regardless of who manages the program at CDC.
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Why doesn’t the Association have a seat on the federal CFS Advisory Committee?
Appointments to the CFSAC are made by Secretary for Health or his/her designee. The most recent call for nominations was issued Aug. 3, 2010 by the Department of Health and Human Services to replace five of the 11 members whose terms expire on Apr. 1, 2011. The Association nominated seven highly qualified individuals. View our nomination letter. In addition, Kim McCleary has attended every CFSAC meeting and every meeting of earlier configurations of this advisory body since it was formed in 1993, usually presenting testimony or making invited presentations (when she was not serving as a member of the committee). We have worked to make the meetings more accessible to the patient community and in May 2009, for the first time the full proceedings were webcast and archived for viewing later. We also strive to provide useful and timely summaries about the meeting.
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Why doesn’t the Association help individuals in their legal actions arising from misunderstanding about CFS?
The Association has long maintained a policy of not becoming involved in individual CFS patients’ medical care or legal proceedings, even when requested to do so. In some cases this policy is very difficult to uphold due to the urgent nature of the hardship being suffered. However, the Association lacks the medical and/or legal expertise to ascertain, review and evaluate the circumstances and records that would be required to make sound judgments about which situations merit investment of scarce resources. Proceeding without appropriate medical or legal guidance would create a precedent for action that could threaten the Association’s ability to serve the community as a whole through the research and federal policy programs that are consistent with its mission. The Board most recently affirmed this policy in the spring of 2009.
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Did the Association stop Congress from voting “yes” on a name change for CFS?
The short and the long answers are both “no.” Short answer: Congress doesn’t name diseases and it has never proposed or taken a vote on the name for chronic fatigue syndrome. Names for diseases, conditions, illnesses, bacteria, viruses, etc. generally arise from the process of scientific discovery and scientific/medical consensus.
Because of the importance of this issue to the CFS community, since 1998 the Board of Directors has maintained authority for setting and communicating Association policy on the name change. The Board has supported a name change since the term "chronic fatigue syndrome" was first introduced in 1988. Our position remains that “CFS” is misleading, and that it does not adequately describe the serious and complex nature of the illness. The Board is energized by the high visibility dialogue about the issue and the prospect for progressive action by government agencies. We are actively discussing the latest research and policy developments and their impact on the definition and nomenclature. The Association and its Board are committed to a new name that will facilitate expanded research, improved access to care and benefits, and greater social support for patients and their families. You can learn more about the Association’s involvement in various name change efforts over the years at http://www.cfids.org/advocacy/name-change.asp.
At the Oct. 2010 meeting of the federal CFS Advisory Committee, the committee made a formal recommendation to the Secretary to, "Adopt the term 'ME/CFS' across HHS programs." The CFIDS Association's Board eagerly anticipates the department's response to this recommendation.
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EDUCATION AND COMMUNICATION
Does the Association work with other CFS/ME organizations?
Over the years we have collaborated with dozens of ME/CFS organizations from being a founding member of CACTUS and IFMEA in the early years; to working closely with ProHealth to expand research and education; to organizing the CFIDS Support Network of hundreds of local, regional and state support groups, the Youth Campaign for CFIDS and CFIDS Youth Alliance; to providing financial support for conferences and other educational activities conducted by AACFS (now IACFS/ME), several state organizations, OFFER, PANDORA, HHV-6 Foundation; to advocating for the formation and chartering of the federal CFS Advisory Committee; to sponsoring 14 Capitol Hill lobby days for hundreds of advocates from across the country; to supporting and sustaining researchers in academic institutions studying CFS, and more. If you’d like to receive a complimentary copy of our 20-year history publication (2007) titled, “Defining Moments,” please send your request and mailing address to cfids@cfids.org.
More recently our efforts have been directed to establishing partnerships with organizations that will help to expand attention paid to CFS, like those with Research!America, Genetic Alliance, Chronic Pain Research Alliance, Alliance for Taxpayer Access, Cold Spring Harbor Laboratories, the Biomedical Information Research Network and industry including biotech and pharma. In the spring of 2011, we will announce the formation of a Scientific Advisory Board of Scientists, physicians and professionals engaged in the research enterprise from top intitutions across North America.
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I haven’t received an issue of the CFIDS Chronicle since January 2009? What happened to it?
As announced in the winter 2009 issue of the Chronicle, the last edition published, the magazine format of the Chronicle had become too expensive to produce, print and mail and many readers had indicated a preference for electronic news that came more frequently. We have published two issues of a new newsletter style print publication, SolveCFS: The Chronicle of the CFIDS Association of America, and the mailing list for our monthly e-newsletter, Research1st News (formerly known as CFIDSLink,) continues growing. We update our Facebook page daily (and sometimes multiple times a day) and in 2010 we hosted a series of webinars on high-interest topics to serve the information needs of our supporters and the CFS community. The recordings are available on our YouTube site. We will co and 2011 ntinue to assess and improve the ways we serve the diverse interest of people who care about CFS and the work of this organization.
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STRUCTURE AND FUNDING
How much are members of the board of directors paid, and how many directors are there?
Members of the Association’s board of directors are (and have always been) unpaid volunteers. The size of the board varies slightly from year to year (15 in 2010; 13 in 2011). Four of the current directors have CFS, ranging in severity from complete disability to being fairly high functioning. The other directors are deeply connected to CFS through family members, close friends and professional endeavors. Kim McCleary, our chief executive officer, has a seat on the board, a common practice among nonprofit and corporate boards. With 20 years of service to the organization and two family members with CFS, she provides important institutional memory and continuity. Meet the current board members.
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How many staff do you have? Are they paid more than other people working in nonprofits?
The Association’s staff is just five full-time people, working from very modest office space in Charlotte. Two of our staff members, CEO Kim McCleary and chief financial officer Kris Hopkins, have been with the Association for 20 years and two others have 10 years of service or more. This is unusual for the nonprofit sector, where turnover can be high. This longevity is one of the Association’s assets and it provides our staff with a deep understanding of the history and the challenges of CFS and the movement.
Each year, a committee of the Board evaluates the performance and compensation of the chief executive officer. Our annual audit by an outside firm includes a compensation review according to market and sector norms compiled by sources such as Guidestar, Abbott/Langer, the National Compensation Survey, Charlotte Chamber of Commerce, Department of Labor, Chronicle of Philanthropy, North Carolina Center for Nonprofits and American Research Company. The compensation levels paid to our staff members are below regional and sector norms. Outside observers frequently comment on how "lean" and efficient the staff is compared to other organizations and companies. Meet our current staff members.
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Do staff members contribute financially to the Association?
Our staff has a strong record of financial support for the organization with the President & CEO ranking among the top donors to the Association.
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Why did the Association accept funding from CDC to do physician education and public awareness?
There are numerous models for nonprofit organizations to raise the funds necessary to pursue their missions, and seeking federal contracts is a very common source of nonprofit funding. In 2001, after the CDC agreed to restore the $12.9 million in CFS funds that had been diverted to other programs between 1995 and 1998, the Association’s Board of Directors made the decision to compete for contracts that CDC was issuing to expand provider education, and later, public awareness. We believed that our direct participation in these efforts would contribute to more patient-centered messages and vehicles than CDC would have crafted without such a partnership. When the contracts were awarded, they were cost-reimbursement contracts and required that CDC approve all of the deliverables.
With regard to the provider education contract, by 2007 there were too many philosophical differences in our approaches and we declined the opportunity to obtain a “sole source” continuation.
The public awareness contract was funded by the National Center for Health Marketing and final requirements were met on June 30, 2010, ending the contract and the campaign. The National Center for Health Marketing was dissolved in CDC’s recent reorganization. We have no intention to seek new contracts from CDC, although we have applied for research funding from the NIH and Department of Defense and will evaluate other federal funding opportunities that are fully consistent with our mission and strategy.
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How often does the Board meet?
The Board of Directors meets at least monthly. Most of those meetings take place by telephone conference call. Two to three times a year, the Board meets in person for an intensive session of review, planning and discussion. New Board members are provided an in-depth orientation session at the beginning of their terms, and directors may also meet in smaller groups at other events like conferences, meetings with lawmakers and special events. Committees of the Board meet with varying frequency, depending on their charges and the needs of the organization.
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Is the Association’s membership declining?
In 2009 the Association announced a decision made by the Board of Directors to consolidate its support structure and eliminate a rather confusing distinction between members of and donors to the organization. This change reflected a broader trend in the nonprofit sector in which membership-based charitable organizations were giving way to donations-based organizations. Membership structures are now almost exclusively utilized by professional societies or educational institutions, like bar associations and alumni groups. The North Carolina Secretary of State approved amended Articles of Incorporation formally revising the Association’s structure on April 28, 2009.
Beginning June 1, 2009, anyone who made or makes an annual gift of $35 or more receives our print publication, SolveCFS, three times a year. Our monthly e-newsletter, Research1st News (formerly known as CFIDSLink,) is free to all. An advantage to the change to our structure is that donations are fully tax-deductible, whereas membership dues were not (according to current IRS code).
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How does the Association "rate" with charity watchdog services?
For each year of its 23 years of operation, the Association has maintained low overhead, fundraising and management expenses. The Association has always exceeded the federal IRS requirements for disclosure, reporting and transparency, including new reporting requirements that went into effect for 2009. Our 990 and an annual report for 2010 are available on our website. The 2011 external audit has been recently completed and the 990 will be posted on the website later this year, consistent with IRS requirements.
In 2007 and 2008 the Association earned rare 4-star consecutive year ratings from Charity Navigator. Due to the combined impact of the slowed economy, the decision to withdraw from CDC contract, and the completion of the first phase of our restricted research campaign, the reduction in our revenue between 2009 and 2008 affected the capacity score with Charity Navigator and the Association was rated with two stars.
As of April 16, 2010 the Association meets all of the Better Business Bureau’s 20 standards for charity accountability, making it the only CFS-related organization to be accredited under the Wise Giving program.
The nonprofit sector is not generally well understood and issues pertaining to overhead, staff salaries and infrastructure don’t paint a complete picture of any nonprofit organization. Nonprofits are expected to do more with less and to generate enormous “returns” on donors' investments by taking on huge missions such as curing diseases, ending homelessness and eliminating poverty. For an in-depth look at some of the differences between for-profit and nonprofit organizations, see the article “What Business Executives Don’t Know – But Should – About Nonprofits” from the summer 2006 issue of the Stanford Social Innovation Review. SSIR also published an article titled, "The Nonprofit Starvation Cycle," in its fall 2009 issue that is valuable reading for those interested in how low overheads can distort and undermine the nonprofit sector.
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What is the Association’s mission?
The Association’s board and staff engaged in a lengthy and intense strategic planning process in 2008 and 2009. As announced in April 2009, the Board adopted new statements of our mission, strategies and core values.
Our Mission:
For CFS to be widely understood, diagnosable, curable and preventable.
Our Strategy:
To stimulate research aimed at the early detection, objective diagnosis and effective treatment of CFS through expanded public, private and commercial investment.
Our Core Values:
To lead with integrity, innovation and purpose.
All our work is guided by these statements, and we have drawn on this new focus in a variety of ways. We revamped our publications, initiated additional online communications strategies, engaged new government relations counsel and expanded our research efforts. These changes have also impacted how funds are directed and resources, including staff time, are invested. Those changes will continue to be implemented as we undertake new initiatives. Individually and collectively, we strive to do our very best to make meaningful progress in the battle against CFS. We never give up and we never let up.
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Updated last on March 10, 2011
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