Jill McLaughlin 4. maj 2004 The third meeting of the CFS Advisory Committee was held on Monday, March 22, 2004 in Washington. D.C. Name Change Dr. Bell brought up the name change as the first order of business. He acknowledged that the committee was harshly criticized for what many considered a perfunctory handling of an issue of such intense importance to the patient community. He maintained that this was not the case and that the committee gave it adequate consideration and defended the committees actions and position as based on "best advice." They remained unconvinced that a name change would diminish problems without creating new ones. No member of the committee voiced support for re-opening the issue at this time, although there was agreement that the topic would continue to be evaluated at each meeting and would be reconsidered if additional evidence would warrant it. Overview of the Scientific Review Process The highlight of the meeting was a presentation by Dr. Terry Hoffeld, the Scientific Review Administrator (SRA) of the National Institutes of Health (NIH) Center for Scientific Review (CSR). The SRA is the designated federal officer with overall responsibility for the review process. Dr. Hoffeld is the SRA of the special emphasis panel which oversees the review of grant applications for CFS research submitted to NIH. He assembles the review panels and he described the grant application process and gave a detailed overview of the scientific review process. Grants are awarded by a dual review process. The first level of review is the Scientific Review Group and the second level is through the National Advisory Council. The CSR is the central point of receipt of applications and conducts the initial scientific merit review and then assigns applications to review groups/study sections. They are sent to Standing Study Sections (which is composed of permanent members) when the subject matter of the application matches the referral guidelines for the study section or to Special Emphasis Panels (which is composed of ad hoc members) when the subject matter doesn't fit into any established study section. The review group then scores the application, giving it a scientific merit rating based on a priority score and then a percentile rating (based on the priority score and calculated as the rank of the application relative to others over 3 review cycles). Awards are made based on scientific merit, program considerations, and availability of funds. NIH grants funded for FY 2004 totals 27 billion dollars and a breakdown was given by mechanism, the majority being awarded extramurally. Over 60,000 grant applications are submitted to the NIH per year and approximately 25-30% are funded. When asked specifically about CFS grants, he estimated it was around 25 percent funded. When asked about the specific problems that researchers have reported on getting funding for CFS studies, Dr. Hoffeld said that CFS grants often are not funded due to a lack of innovation or a sub-standard presentation of study aims and protocols. [Many have questioned this as a valid reason. Many researchers who have had no problems getting grants in other areas have reported that they cannot get funded for CFS. He was asked about the 25% funding rate, and it appears that was for several years ago based on the GAO report. When asked about the more recent levels he said he did not know.] It appears that there has been little "programmatic interest" - that is, there is no one at NIH who is actively involved in research on CFS. Basically projects on "chronic fatigue" would be "extramural" - outside the institution. "Chronic Fatigue" is the name he continually used for the illness. CFS grants, along with fibromyalgia, are reviewed by a SEP, which falls in the division of MOSS - Mulscular, Oral, Skeletal, and Skin diseases. Dr. Bell opened up a discussion about "Where did this go wrong with regard to CFS," noting that the method currently set up has not been very successful. [I think the answer is obvious from the paragraph above. It seems clear that viewing the illness as "chronic fatigue" and studying it as such is a dead end and has generated little interest within any discipline. Which is not surprising. Pat Fero expressed deep dismay that physicians in Wisconsin were not interested in the illness. Think this is why. Then she discussed recommendations for setting up fatigue consultation clinics in Wisconsin.] NIH Following Dr. Hoffield's presentation, Dr. Eleanor Hanna then addressed specific questions about CFS projects being funded by NIH. Dr. Hanna heads the CFS research efforts at NIH within the Office of Research on Women's Health. She reported that she had requested a list of grant titles and investigators from the NIH and would share this with the committee when it became available. She reported that there was some intramural research underway but there is no specific lab at NIH devoted strictly to CFS research. At NIH, CFS is being addressed as an interdisciplinary issue that crosses multiple institutes. It is not "in" any one area. The trans-NIH group is attempting to co-fund projects. For example, Dr. Goldstein, a neurocardiologist, is now focusing on Chronic Fatigue Syndrome. The "science of integrated medicine" group will be organized to include CFS and other cross-disciplinary illnesses. She announced that there was strong interest from NIH scientists and was forming a new group with a steering committee for intramural researchers to to work on multi-symptom illnesses using an integrative approach, which was expecting to start meeting in April. The CFSAC considered several possibilities for increasing NIH supported research, including recommendations to establish a CFS intramural program, create a post for a CFS research coordinator or call for CFS centers of excellence or clinical trials. Dr. Bell suggested the committee explore these possibilities further and set recommendations at the next meeting. A research subcommittee was established to conduct additional inquiries. The CFSAC considered ways of increasing NIH research, such as appointing a CFS research coordinator at NIH, establishing a CFS intramural program, or recommending CFS centers of excellence or clinical trials. Dr. Bell suggested the committee explore these possibilities further and set recommendations at the next meeting. A research subcommittee was established to explore other possibilities. Centers for Disease Control (CDC) Dr. William Reeves of the CDC reported that his CFS research group is continuing its molecular epidemiology studies. Work is still underway on the Wichita studies. CDC is awaiting approval for a population study in three distinct regions of Georgia and is working with academic researchers, including a group at Emory University. He was asked questions about staffing levels, responding that he was still short three additional scientists. The committee proposed a recommendation to the Secretary that three full-time equivalent (FTE) positions be filled at the CDC's CFS research group. Social Security Administration (SSA) Social Security Administration (SSA) representative Bill Anderson announced that SSA would conduct an interactive video training on CFS for disability evaluators on April 1. He said that in 2000, 255 people were approved for disability out of 2000 case filings; last year 833 people were approved out of 4326 filings. Prior to the 2000 it was difficult to tell how may people with CFS applied for or received disability. SSA is also tracking approvals and denials for CFS-related disability cases to identify disparities. At the last meeting, committee member Lyle Lieberman, a disability attorney, was asked by Dr. Bell to look into the ways to assist those who struggle at the initial and reconsideration level to deal with the most difficult part of adjudication. He spoke to present and past physicians, adjudicators, and colleagues to get an idea as to how they were doing representing clients at the initial and adjudication level. Those with whom he consulted gave widely varying perspectives. The adjudicators did agree that they all needed more training. Physicians looking for markers where there are none have the most difficulty. Many problem occur at the state level levels. When social security rulings came out and there was nationwide training, it was hoped that things would fall into place. Increasingly there are people who have never had any training, or realize that rulings that stated that a CFS approval does not require hard evidence from testing. He noted that because symptoms such as pain suggested a greater degree of disability than can be shown objectively alone, the decision cannot be made solely on objective evidence =AD evidence that a person cannot work cannot be disregarded simply because there is no way to prove they have a disease. He emphasized the need for continuous training due to the high rate of turnover rate of those who handle disability applications at the first and second level of review. A subcommittee was formed to examine disability issues and Mr. Lieberman was appointed as Chair. FDA Dr. Cavaille-Coll said that FDA had no report. When asked if there was any more information about blood transmissability, he did not have a response and deferred the question to CDC, but neither did Dr. Reeves. HRSA Dr. Robinson said that HRSA had no report for now but he would continue to encourage specificity in terms of recommendations from the educion subcommittee. He said that what has happened in the past in terms of general comments nothing specific that HRSA can use. Dr. Bell emphasized the need to recognize the the educational needs of children. Dr. Robinson responded that perhaps there could be cooperation between the education department and HRSA's public health initiatives that concern school-age children. Dr. Bell said that CFS is extremely difficult to diagnose in young children. After the onset of puberty the symptoms become full-blown, and sometimes can then recognize the roots in childhood. He said that the issue of diagnosis in young childhood depends on a diagnosis of secondary gain and did not know how to approach this. Dr. Lapp said that they look at the level of fatigue and cognitive difficulties, which is difficult to determine other than in relation to their peers. Education Dr. Roberto Patarca was unable to attend in person due to travel complications, so the segment on education was cut short when the conference call proved too difficult to follow. He managed to address various issues that the education subcommittee will take up before the June meeting. In addition to the provider education, Patarca stated that they would look at allied health professionals and problems children with CFS experience with schools. Dr. Bell considered these topics as high priority and reinforced the need to formulate recommendations to discuss at the June meeting. The next part was supposed to be a report by Dr. Roberto Patarca on education, but he was forced to have to try to do this by way of a conference call because he was stuck in an airport in Miami. He began to give his report, but the voice presentation proved very difficult for even the healthies on the committee to follow. Dr. Bell, noting the time, interceded and suggested that education should be made a formal subcommittee. The committee voted yes, and Dr. Patarca was volunteered for the job. Consequently his report was postponed until the next meeting, when the subcommittee could give a more thorough report. Subcommittees formed Three subcommittees were formed and a preliminary recommendation to the Secretary was proposed. Subcommittees will be used between meetings to gather information, lead inquiries and draft recommendations for consideration by the full committee. Dr. Patarca will head an education subcommittee; Attorney Lyle Lieberman will head a disability subcommittee and a chair will be selected for the subcommittee on research. Other Presentations Three patient organization representatives addressed the committee and eight other advocates spoke during the public comment period. Pat Fero, president of the Wisconsin CFS Association, spoke about NIH-funded research, information about a house their organization is building in Sun Prairie, Wisc., and the group's hosting of American Association for Chronic Fatigue Syndrome (AACFS) conference on Oct. 8-10 in Madison. She gave an overview of the organizations work and their attempt to work with the University of Wisconsin to put together a program for CFS. They brought a petition with 2000 signatures to the University requesting a meeting to set up the program in 1994. They sent a representative to the AACFS conference, who came back with ideas for diagnosis, treatment, and care. Since then, there has been no progress and at a final meeting with the University they were told that told at a final meeting of Wisconsin that "no one is interested here (in CFS)." They then began the PANDA project (Patient Alliance for Neurological Disorders) to create, implement, and support a clinic for patients with like disorders. The group has found themselves calling it more of a "fatigue" consultation clinic - not because they believe in CFS as a name, but because they don't want labels and names to be looked at. They looked at a whole host of other illnesses - chronic Lyme, post-polio, transverse myelitis - a lot of similar illnesses where patients are dissatisfied with the knowledge. Kim (Kenney) McCleary, President and CEO of the CFIDS Association of America (CAA), spoke of their efforts on education, public policy and research and plans for a new interactive web site feature. She highlighted provider education initiatives and responded to questions raised at the last CFSAC meeting about the CAA's contract with CDC for education, which was an an attempt to shift the funding burden for education to the government. She noted that the name is a problem and said it is time we addressed it, but it is important that a new name does not acquire the stigma that the old one has. She said they were also attempting to understand the factors that underlie the doubts and suspicions because of the name. They are using social science research such as focus groups and public polling to clarify the issues that lead to the stigma. They are finding that the stigma results from a complex interaction of societal values, personal experience, and people's lack of understanding of the illness. She said, "We are trying to teach people to care." She noted that when Laura Hillenbrand (a CFS patient) released her book "Seabiscuit," a lot of people 'got it' and wondered how that happened and what Laura said that worked? Referring to a statement made by Dr. Bell at the Dec. 8 meeting, "...the disrespect patients experience is not just caused by the name," she noted the Association's commitment to continue with credibility-enhancing efforts until consensus for a name change can be broadened beyond the patient community. Eight members of the public presented very thoughtful, moving and informative testimony. They conveyed the difficulties they faced getting diagnosed and living with the illness or caring for someone with it. Members of the committee and HHS support staff have been respectful and willing to make allowances for patients needs at the meeting. Jon Sterling was allowed to read testimony for a friend of Laura Hillenbrand who was unable to attend and I was allowed to help a patient needed some assistance with her testimony. Public testimony was given by: Dr. Beverly Bugos, Virginia Carey Czarniawski,New Jersey Eileen Holderman, New York Chris Kraus, Wisconsin Marly McKibben, Florida Carol Rowland, Washington, D.C. Peter White, Virginia Sharyn Williams, New Jersey (mother of Carey Czarniawski) Mary Schweitzer was not scheduled but Dr. Fields opened up discussion at the end to allow the public further opportunity to comment and she did a very good ad lib end of the day presentation. She spoke of the needed sense of urgency and referred to deaths and suicide, and gave a reminder to consider the 80-90% who are not even able to get a diagnosis. She spoke of the need for a name change and to recognize the NCW's work and noted that Parliment was going to adopt the name CFS/ME for now. She referred to the UK campaign to ask for 1% of what the disease cost in terms of lost productivity. And since the CDC just came up with a loss of 9 billion, thus suggested asking Congress for the same percentage (i.e., 90 million) for research. The committee expressed intent on taking public concerns into consideration in formulating recommendations to the Secretary and plans to make a slate of recommendations covering a range of topics at next meeting. Dr. Bell then adjourned the meeting and said the next meeting was planned for mid-June. Jill McLaughlin Executive Director National CFIDS Foundation