CFSCC Index
Public Testimony at the April 1998 Meetings
List of Members of the CFSCC 1997-99
CFS Home Page at the Centers for Disease Control (CDC) website
Department of Health and Human Services
Public Health Service
Centers for Disease Control and Prevention
Meeting of the
Chronic Fatigue Syndrome Coordinating Committee
(CFSCC)
April 29, 1998 Note: These are the official minutes sent by the CDC to meeting participants in September 1998. Except for the addition of hyperlinks and the two pictures in Sara Bass's testimony that were shown as slides during the meeting, the document is unaltered. Since the meeting was open to the public, this document is in the public domain, and has been posted here by Mary Schweitzer, webmaster for The CFIDS/M.E. Information Page.
The third meeting of the Chronic Fatigue Syndrome Coordinating Committee (CFSCC) was convened by the Department of Health and Human Services (DHHS), Public Health Service (PHS) on April 29, 1998, at the Hubert H. Humphrey Building in Washington, D.C. Dr. Brian Mahy, Committee Co-Chair, called the meeting to order at 9:40 A.M.
Table of Contents
- Members in Attendance
- Others in Attendance
- Agenda Items
Introduction/opening comments
Review of the Minutes
Discussion of CFSCC Priorities - Agency Updates
- Comparison of Gulf War Syndrome and CFS
Presentation of DVA-Funded Gulf War Syndrome Research
Discussion
Presentation of CDC Research on Gulf War Syndrome
Discussion - CFS Information and Education
Physical Education
Discussion of the AACFS Conference
Analysis of Distance Learning Teleconference - Review of an Approach to the Current Disease Name
Statement by Roger Burns
Discussion - Presentation of the Scientific Session on CFS in Adolescents
Discussion - Public Testimony
Ms. Emilie Sutterlin
Mr. Albert Donnay
Ms. Sara Bass
Ms. Jill McLaughlin
Ms. Vicki Walker
Dr. Mary Schweitzer
Mr. Tom Hennessey
Ms. Pat Blankenship
Ms. Gail Dahlen - Closing Comments
- Gerald Ross Crum
- CFS Advocate
- Aba Heiman
- Attorney at Law
- K. Kimberly Kenney
- Executive Director
The CFIDS Association of America - Nancy G. Klimas, M.D.
- Professor of Medicine
University of Miami School of Medicine - Anthony L. Komaroff, M.D.
- Professor of Medicine
Harvard Medical School - Kristin E. Thorson
- Founder and President
The American Fibromyalgia Syndrome Association, Inc. - Brian W.J. Mahy, Sc.D., Ph.D
- (Committee Co-Chair)
Centers for Disease Control and Prevention (CDC) - Marc Cavaille-Coll, M.D., Ph.D
- Food and Drug Administration (FDA)
- Carol S. Gleich, Ph.D.
- Health Resources and Services Administration (HRSA)
- George T. Curlin, M.D.
- National Institutes of Health (NIH)
- Carolyn Kiefer
- for Karen Ezrine, M.D.
Social Security Administration (SSA) - Patients in both samples had intake questionnaire data consistent with having "severe" CFS
- The veteran population was comprised of significantly fewer women (32% vs. 81%) and Caucasians (71% vs. 96%), due to the demographics of those who served in the Gulf.
- Significantly less MCS and FMS were seen in Gulf War veterans with CFS than in non- veterans.
- The rate of Axis I diagnosis developing in those who had not been so diagnosed previously is not different between veterans and civilians.
- However, the mode of illness onset (sudden versus gradual) was very different: 8% of sudden onset in veterans indicates a less infectious onset, versus 79% in non-veterans. Sudden onset was defined as illness occurring within 36 hours.
- Significantly fewer veterans than civilians still fulfilled the definition for severe CFS.
- The veterans also were less severely affected on illness impact, reporting cutting back their activities for 7 days versus the non-veterans' 15 days, and fewer veterans had to leave the workplace.
- So when both groups were assessed, using the same intake criteria, the CFS in Gulf War veterans appears to be less of a problem than that in non-veterans. There are fewer cases of severe CFS after evaluation, less comorbidity with MCS and/or FMS, and their illness produces less disability. These data suggest that Gulf War veterans have a better prognosis and, inferring that the illness is milder than in civilians, will have a better response to treatment. DVA has announced a cooperative Centers therapeutic trial for Gulf War Illness, which will focus on Gulf War veterans with FMS and CFS.
- an unusual illness affected the 193rd Air National Guard;
- if Air Force Gulf War veterans were more likely to be ill than non-deployed troops, and
- to craft a case definition.
- medical school. Curricula development is guided at 2-3 meetings a year, at which time important areas can be incorporated if promoted;
- staff level education occurs at grand rounds and other symposia, and training in the former venue is more accepted from an external visiting professor. The AACFS tried to facilitate this with their Speakers Bureau. A visiting professor program should be developed to deliver more house staff and faculty training;
- continuing medical education is demanded at the state level, but for the rest, CME credits must be developed to justify the physician's time investment.
- What can be done to ensure that the stigma of the illness plays a paramount role in determining when a name-change can occur?
- What can be done to promote an appropriate name-change as soon as possible?
- Is a parallel eponym a viable option (to minimize the confusion of an abrupt name change)?
- Could an eponym be government policy only? (A governmental eponym would avoid the need to reconvene the 1994 committee and avoid the perception that the government is trying to dictate to the scientific community.)
- Could "myalgic encephalopathy" be adopted? ("Myalgic encephalbmyelitis" was discussed at the last meeting.)
- How can we show that there is a body of work which indicates that CFS is much more serious and legitimate than we knew it to be 10 years ago?
- Can such legitimacy justify some name change now?
- What should the new name be?
- What can be done to strongly and actively promote a name-change process?
- How should the Surgeon-General present a dramatic announcement that legitimizes CFS (and which hopefully announces a name change)?
- What can be done to garner support for a CFS legitimization program from medical officials outside of the CFS community?
- the CFSCC make specific recommendations to the DHHS Secretary through a survey of the workshop participants' research priorities. The CFSCC could summarize and distribute those recommendations before its October meeting, at which it could craft a recommendation to the Secretary.
- NIH issue a cross-institute multidisciplinary program announcement for the individual agencies with funding commitments focused on children and adolescents with CFIDS.
- CDC should work with adolescent medical specialists to develop collaborative studies to accurately measure the prevalence and impact of CFS on children.
- HRSA should include information about adolescents with CFS in all health care provider educational activities, particularly targeting pediatricians. The previous day had been the first time she heard near-consensus that making the diagnosis of CFS in children is the first step of ensuring treatment. Pediatricians must be aware of this.
- Finally, she recommended a follow-up conference to determine that outcomes ensue from the workshop. She left a booklet for the committee by the Alliance which contained summaries of 36 young people with CFIDS, and she urged the committee to take seriously its charge, especially for young people with CFIDS.
Centers for Disease Control and Prevention (CDC)
Discussion
National Institutes of Health (NIH)
Discussion
Social Security Administration (SSA)
Discussion
Food and Drug Administration (FDA)
Discussion
Health Resources and Services Administration (HRSA)
Members in Attendance
Note: A full list of CFSCC members, affiliations, addresses, and terms of office, can be found at http://www.cfids-me.org/cfscc/members.htmlPublic Members in Attendance
Ex-Officio Members in Attendance
Others in Attendance
Lillian Abbey, Mitch Abraham, M. Tauhid Au, Sara Bass, Pat Blankenship, Richard Bruno, Roger Burns, Bryan D. Carter, Lyvon Covington, Gail Dahlen, Albert Donnay, S. Geroux, David Greenwood, Doralee Halperin, Tom Hennessey, Joann House, Karen Jordan, Jill McLaughlin, Paul Levine, Gary S. Marshall, Michael Melneck, James W. Moore, Rebecca Moore, Benjamin H. Natelson, Nannette Pepper, Lisa Putman, William C. Reeves, Richard Riseberg, Leigh Sawyer, Mary McKinney Schweitzer, Tom Sheridan, Betty Spencer, Jonathan Sterling, Julian Stewart, Emilie Sutterlin, Vicki Walker
AGENDA ITEMS
Introduction/Opening Comments
Dr. Mahy welcomed the attendees to the official meeting of the CFSCC, which followed a day- long CDC/NIH State of the Science Workshop on Chronic Fatigue Syndrome in adolescents. He announced that the new CFSCC Chair is David Satcher, M.D., Ph.D., who is also the new Assistant Secretary of Health and Surgeon General. (Dr. David Satcher attended the meeting in the afternoon to hear the public testimony.)
Review of the Minutes
Dr. Mahy reviewed the minutes of the last meeting, Chaired by Dr. Jarrett Clinton. Discussion was held on CFSCC goals; whether the committee could influence budgeting to address CFS; discussion of how to relate the committee's concerns to the DHHS Secretary; discussion on the committee's budget (channeled through CDC}, and discussion of the CFSCC's accessibility to the community when meetings are held in Washington, D.C. The latter included the difficulty of including videotaped testimony in the agenda, but it was noted that such perspectives can be channeled into the committee's record through the CFSCC members representing various aspects of the communities affected by CFS.The action items pending from the last meeting included a request for a delineation of the agencies' funding of CFS research. Since NIH had not closed its books as of the last meeting, it was unable to provide its final figures. The National Institute of Allergy and Infectious Diseases (NIAID) is the lead Institute at NIH for CFS research, and Dr. Curlin chairs the NIH CFS Coordinating Committee responsible for coordinating NIH CFS research. Two packets were provided which delineated NIH's support of CFS research. In fiscal year 1997 (FY97), total funding was $7.23 million; $7.513 million is estimated for FY98. A line listing was provided of all the extramural and intramural NIH CFS projects, including figures on NIH support for fibromyalgia research. Also provided was information on the computerized CRISP system, which solicits grant proposals and summarized the grants available. Dr. Curlin suggested that all these documents be officially appended to the minutes (see Appendices A and B).
Ms. Thorson asked why taxpayer dollars were being used to save health maintenance organizations (HMO) $1200/year in patient costs, as delineated by Dr. Teresa Cronin's (San Diego) abstract of NIH research. Ms. Thorson particularly objected to such federal support of the use of behavioral methods to screen patients and educate them on when it is appropriate to see a doctor. She also questioned allocations of $400,000 per year on sleep and rest behaviors in the mouse, research which seemed inapplicable to humans, but is labeled as sleep studies on fibromyalgia syndrome (FMS). She was a little more impressed with the research on CFS, although she saw a few problems in some of the psychosocial components.
She asked Dr. Curlin to look into these objections, but he respectfully declined to do so. He explained that the NIH's annual grants system defers to the reviewing peer experts to review, score, and select individual research applications for awards. Although unanticipated results can arise, the system works well for basic research. It attracts work proposals for which at times the outcome may be unclear, but the approach is of sufficiently high quality to merit the award. Dr. Cronin's, for example, was one such. Ms. Thorson asked if these applications were reviewed by a Special Emphasis Panel (SEP), and Dr. Curlin agreed to check on that.
Ms. Kenney reviewed a distributed table which outlined the history of NIH applications, and asked if the grants to the National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS) would cross over to FMS or CFS. Dr. Curlin thought they might apply to CFS since some of the fundamental physiology might be applicable, but also noted that these grants were in response to specific Requests for Applications (RFA). Ms. Kenney noted with interest that historically, the funding has followed the development of research. For example, CFS research began in NIAID with work on Epstein-Barr virus (EBV). As more was learned about CFS, NIH invited other fields of science to participate by means of RFAs and Program Announcements (PAs) and hence the research focus was broadened. This was successful in expanding the research to include the National Heart, Lung, and Blood Institute (NHLBI) as well as others. Dr Curlin in reviewing the Table which showed the history of grant applications to recent CFS PAs noted that the grant review scores reflect both excellent applications and others that would not be funded. While NIH can fund marginal applications in an attempt to be inclusive, they will not fund flawed applications. He thought the current Program Announcement (CFS Pathophysiology) with Dr. Leigh Sawyer's help had been successful in attracting good research. The "payline" at NIAID is at 24%, but he was unsure about other Institutes.
In other areas of the minutes, Dr. Gleich corrected the spelling of Marilyn Gaston's name on page 12. Dr. Mahy reported that Dr. Suhadolnik had been invited to this meeting and the workshop, but was unable to attend. He may come to a future meeting. With no further corrections, the minutes were unanimously approved.
Discussion of CFSCC Priorities
Ms. Kimberly Kenney read a statement which recognized the benefit of the CFSCC's regular assembly to discuss issues pertinent to CFS and to make recommendations to DHHS and SSA. However, the need for members to work independently of each other most of the year, and a lack of direction and focus, undercuts the CFSCC's ability to meet its very diverse responsibilities. The CFSCC could address any of multiple issues. But since its charge is to ensure communication and coordination, and to advise DHHS and SSA, it must work within those agencies' scope of activities. While limited, the existing body of knowledge about CFS/CFIDS supports the seriousness of this disease and its dramatic effect on its patients. Patients have vigorously asked that CFS be better legitimized. The CFSCC must be clear that CFIDS is real, serious, and complex.Ms. Kenney had polled as many CFSCC members as she could reach about the committee's priorities. Among these were 1) to expand research on CFS (this was addressed at the previous day's workshop); 2) to augment health care provider education activities (a possible activity by all the agencies represented on the CFSCC except perhaps FDA); 3) to improve access to SSA's disability benefits (by taking advantage of the agency's presence on the CFSCC); and 4) to execute the CFSCC's charter to provide coordination and ensure accountability of the federal agencies' CFS programs (facilitate communication, recommend research and budget priorities, ensure regular reporting of agency activities). Ms. Kenney found general agreement that her four topic areas were a focus for the CFSCC. Ms. Thorson added her wish that the committee members stay better in touch between the meetings.
Mr. Heiman focused on a physician's comment at the workshop that research must be coordinated to avoid duplication of effort. Dr. Curlin agreed, but also distinguished between duplication of work and the advantage of having more than one group addressing a problem from different perspectives or even different nuances. While the NIH CFS Cooperative Research Centers currently coordinate well, there was also discussion at the workshop of creating another Center to foster the participation of non-NIH researchers and to encourage interdisciplinary approaches.
Mr. Heiman asked if a way existed to coordinate research centrally other than that done by NIH, since the CFSCC's charge is to advise the Secretary on complementary research in order to minimize overlap. Dr. Komaroff stated that NIH's annual meetings on CFS is one way to accomplish this, as well as the international conferences such as those held on CFS every two years by the American Association for Chronic Fatigue Syndrome (AACFS). Mr. Heiman suggested that someone from the board of the AACFS present at the next CFSCC meeting on the research desired and on the insights gleaned from their planned October meeting. This could expand the perspective of the NIH peer reviewers who review NIH. He suggested that the CFSCC meet after the AACFS meeting in October to hear their recommendations.
Mr. Crum added his own appreciation of the previous day's exciting workshop, which he thought a benchmark process that could be fine-tuned. For example, he wanted the scientists' recommendations on research, and he wanted to track the outcomes of any of their recommendations or those made by the CFSCC.
Dr. Klimas stated that the research agenda is driven by NIH's calls for proposals. She summarized that the CFSCC would like to give better direction to the focus of the research, such as by pointing out the weakness in the knowledge about pediatric CFS. The excellent NIH and CDC workshops in last 7-8 years already have pushed the research agenda, leading to the RFA on the shared list. CFSCC now has the privilege to further advance the agenda, observe the process, and point out any weaknesses perceived by advocates or other investigators. She applauded the workshop as very productive, creating a momentum on which the CFSCC can build.
Dr. Mahy agreed with the appropriateness of the coordination and communication roles raised by Ms. Kenney. He noted that the CFSCC's very existence indicates the legitimacy of this disease as a problem. And, while representation by other associations and organizations can be arranged with member turnover, the committee must also remain open to other groups' viewpoints over time.
Mr. Crum reported his Internet review of [The National Cancer Institute] NCI's 1999 budget proposals, which included coverage of NCI's recent re-evaluation process. The executive summary stated that the NCI's ultimate goal is to prevent or cure cancer, using a three-pronged approach: to sustain the proven research program, to seize extraordinary opportunities to further the progress made possible by previous discoveries, and to create/sustain mechanisms allowing rapid translation of findings from the laboratory into practical applications that benefit everyone. As a patient, he focused particularly on the last statement. Everything done on this committee should be measured for its effectiveness. He agreed emphatically with NCI's process of canvassing scientists, advocates, communicators, and community leaders to see where a group fails and what it must do to succeed. NCI found that their most serious failing was not pursuing promising leads.
Mr. Heiman suggested that thought be given to how the CFSCC would present its recommendations to the Secretary, whether through the formal meeting minutes or through a paper or summary, and in what steps and time frame this might occur. Mr. Richard Riseberg of the PHS Office of General Counsel stated that the committee has great discretion about its forms of communication aside from the Minutes. Dr. Komaroff appreciated the idea of a CFSCC-developed report on the progress of CFS research, perhaps tracking a few simple measures of the field's progress over time. This could be an agenda item for discussion at the next meeting.
AGENCY UPDATES
Centers for Disease Control and Prevention (CDC)
Dr. William Reeves reported progress in CDC's development of a CFS patient brochure and on its research program.Patient brochure. CDC has been revising its information brochure on CFS, of which almost 250,000 copies have been distributed. The comments solicited in November 1997 from the CFSCC, leaders of the three major CFS patient support organizations, and CDC's CFS Physician Review Committee were incorporated into the draft revision. This in turn was shared in February 1998 with the attendees at a CDC meeting of consultants on pediatric/adolescent CFS, revised again, and then reviewed internally. The last draft was provided to the CFSCC at this meeting. The revision includes a format change, information updates, and new sections on the hypothalamic-pituitary-ad renal axis, neurally-mediated hypotension, nutritional deficiency, recommendations on how to select a patient support group, and additional information on CFS. The new brochure will be printed and ready for distribution by June 1998. Ms. Thorson thought the brochure to be an important education tool which should have more patient input. She suggested that this be a separate agenda item from inclusion in the agency update.
Wichita Surveillance Study. Dr. Reeves reviewed this study's goals. to 1) determine the prevalence of various fatiguing illnesses in Wichita, 2) compare these results with data from physician-based surveillance in Wichita; 3) estimate the incidence of various fatiguing illnesses over a two-year period; 4) compare the prevalence of fatigue, symptom occurrence, and a variety of other characteristics across demographic groups; and 5) identify subjects for follow- up studies of persons with CFS and other fatiguing illnesses.
Phase I (random digit dial survey and clinical evaluation of fatigued respondents) has been completed, and Phase II is underway. Of the over 90,000 persons contacted, 4000 reported fatigue of at least one month, narrowed to 500 fatigued for at least three months who met CDC's CFS symptom criteria. Ensuing clinical evaluations of those persons and a random sample of 60 non-fatigued individuals were reviewed by CDC's Physician Review Committee, which classified the patients as to a medically defined illness, unexplained prolonged fatigue, chronic fatigue, and CFS. When the database is complete, preliminary analyses will begin on baseline prevalence of fatiguing illness, comparison done to the physician based surveillance done 1989-1994, and then statistical analyses to explore alternative case definitions.
Phase II will follow individuals as they transition through various phases of fatiguing illness to estimate the incidence (new cases) of chronically fatiguing illness, and to describe the disease's course. All 8000 original participants will be interviewed through a questionnaire by telephone, clinical exams will be done for those with fatigue [lasting over] 3 months, and reevaluations will be done for all those clinically examined in Phase I. A new clinical component to screen for sleep disorders has been added.
Patient Follow-up and Clinical Course Physician Surveillance System. Clinical data are being collected to better deterrnine the nature of CFS and refine the case definition; provide data for agencies' use in evaluation, insurance and disability issues; evaluate treatment efficacy; and provide information for physician and patients. The follow-up has been completely revised to follow the 160 CFS patients from the 1989-1994 physician surveillance, who are interviewed on their health status every six months. Data analysis now shows a 31 % probability of recovery in patients up to the fifth year of illness, and 47% up to the tenth year of illness. Sudden onset cases (1-2 day onset) had a higher recovery probability than gradual onset. The onset symptoms reported were listed; those over the course of the illness are now being analyzed.
Adolescent CFS. Aside from yesterday's outstanding meeting, a well-balanced related conference was held at CDC in February 1998. The attending consultants represented pediatricians from private practice and academia, including several pediatric subspecialties; a patient advocate; and a CFSCC member. The meeting's conclusion was that the first priority is to determine the prevalence of CFS in adolescents, perhaps by transferring the Wichita protocol to another city. This is being explored with Dr. James F. Jones in Denver. A follow-up consultant meeting will occur this fall to discuss more long-range studies.
Molecular Epidemiology Program. Dr. Reeves updated the committee on CDC's program to use molecular assays to investigate the pathogenesis of CFS and other unexplained fatiguing illnesses. CDC is using molecular genetic profiling technologies to find alterations in gene expression or novel infectious agents. These studies are sufficiently open-ended to allow for unexpected findings. Since there is no known diseased tissue related to CFS, samples of peripheral blood cells and plasma representing a person's systemic state are being used. CDC hypothesizes that gene expression might differ between CFS patients and controls, indicate the pathogenetics of CFS, and perhaps indicate diagnostic markers and new therapy approaches.
Dr. Reeves outlined the technology now available to measure gene expression in epidemiologic studies. Great attention has been given to the analytical methods to be used, particularly in light of the probably limited amount of messenger RNA (mRNA) retrievable from the patients' samples. The mRNA may be significant to CFS pathogenesis, and the isolation procedures must be reproducible. CDC is developing a new method pf chemiluminescent detection to amplify and label the mRNA nonradioactively, a safer method which also allows multiple assays on each sample. Finally, after controlling for the multiple other variables in each experiment, the validity of mRNA expression detected will be validated by models. Then, material from CFS patients and controls can be examined, beginning with pooled lymphocyte samples of Gulf War study patients and controls. Any differences found will be verified in population-based samples.
Discussion of CDC Report
Dr. Komaroff asked CDC's sense of the stability of reported CFS recovery, or how many patients might subsequently have relapsed. Dr. Reeves noted how complicated this is, since life table actuarial techniques usually allow for only one death or recovery. Other methods were found to allow consideration of multiple recoveries.
Dr. Klimas asked if there are sufficient data to distinguish CFS from, for example, chronic active viral infection, but Dr. Reeves said CDC could only hope so. It may be necessary to move from pooled data, assembled to increase sample size, to individual analyses, and to expand the arrays to include other infectious agents.
Mr. Crum asked how CDC identified CFS within the physician-based surveillance. Dr. Reeves clarified that the study subjects are already so diagnosed, and are then classified as to sudden or slow onset, illness duration, and even symptoms. All testing is done in blinded fashion, but any sub-stratification can be done after the initial classifying, and can be done unblinded for follow-up. This all should help in the work to develop case definitions.
Ms. Kenney informed the committee of the CFIDS Association's pursuit of a more detailed accounting of CDC's expenditures. The CFIDS Association felt that information provided by CDC Financial Management Office (FMO) Director William H. Gimson left many important unanswered questions which had been shared with members of the House and Senate. For example, the report cited 1996 supplies and equipment expenditures of $1.2 million at the Branch level and $74,000 at the Division level. Ms. Kenney stated that she participated in a 1996 CDC peer review and there were no laboratory studies reported for that year. Ms. Kenney requested that Dr. Mahy tell the committee what the $1.2 million for laboratory supplies and equipment was spent on that year. Dr. Mahy responded that certainly there were laboratory studies in 1996 and requested that Dr. Reeves confirm that. Dr. Reeves responded that his branch was not doing laboratory studies in 1996 that he was aware of. He stated that the molecular program was begun in 1997 and the Branch was primarily analyzing results that were obtained in 1994. Ms. Kenney also cited a delineation of 100% committee management staff time devoted to the CFSCC. In her opinion this was not needed for a committee only meeting twice a year. Dr. Mahy responded that setting up the committee involved training an employee in committee management. In addition, this employee would be working with the committee for the next two meetings in order to supervise their continuity. The cost of setting up and running the committee are accounted for and costs will presumably be transferred to NIH after the next CFSCC meeting. Ms. Kenney further stated that she had a list of many other questions and just wanted to make the committee informed that the line of inquiry she would be pursuing through the CFIDS Association through the HHS office and with members of Congress.
National Institutes of Health (NIH)
Dr. George Curlin provided funding information for FY97 and abstracts for new FY98 projects. In 1997, NIH supported 15 research projects on CFS and 13 on FMS. Among the 15 CFS projects are two CFS Cooperative Research Centers, which have multiple projects. The two newly-funded grants include Dr. Jones' Denver project, entitled "A Model for Induction of CFS," funded by NIAID and the National Heart, Lung, and Blood Institute (NH LBI) support of Dr. Roy Freeman in Boston to examine the role of orthostatic intolerance in CFS. The NHLBI has recently approved another application, and NIAID is reviewing yet another which looks promising.The annual meeting of CFS Cooperative Research Centers was held earlier in the week, with promising work reported by Dr. Dedra Buchwald's Seattle Center working with monozygotic twins and Dr. Ben Natelson, the Newark Center Director, working primarily in the areas of exercise tolerance and rehabilitation. Copies were provided of a RFA which was released to recompete the CFS Cooperative Research Centers which emphasize a multidisciplinary approach to CFS. For the first time, foreign centers are eligible to compete for independent or collaborative work with domestic Centers.
Dr. Curlin noted that pediatrics had been woven into all of NIH's research, due to a law requiring each research application submitted to the NIH to include consideration of children in their proposals. This has boosted research in pediatric CFS. Copies also were available of the NIAMS' RFA encouraging clinical research on fibromyalgia.
Dr. Curlin provided a chart demonstrating the dynamic growth of CFS research. He commented that the CFSCC can influence NIH research through recommendations, which he and Dr. Sawyer can channel to the most appropriate NIH Center for inclusion in their RFAs. NIH attends to all such committee recommendations. Finally, he noted that the small amount of intramural research done at NIH is done at Dr. Stephen Straus' laboratory. The resources are small, and the program much less ambitious than CDC's. Most of the NIH funding supports academic research.
Discussion of NIH Report
Mr. Heiman asked about Dr. Straus' multidisciplinary studies of CFS budgeted at over $1 million. Dr. Curlin responded that these are ongoing studies begun in NIAID at the time of the suspected EBV link. Dr. Straus also works with many collaborators -- including those doing tilt table research; work develops with new knowledge of the field. Mr. Heiman commented that the research title seemed to invite combined multidisciplinary studies through the NIH. He also asked about the extramural $2.3 million to a "Research Center on the Psychobiology of Ethnicity." Dr. Curlin drew the members' attention to the project summaries provided for such details. He also noted again that although the study's funding amount and title may attract attention, the research is peer-reviewed and accepted. Some research is more expensive than others; e.g., population-based research is expensive and requires a lot of staff because it deals with masses of people. But the merit of the investment must be judged by the final product.
Dr. Komaroff asked [about] NIH's ratio of intramural versus extramural support for illnesses other than CFS, and about the review process for intramural research. Dr. Curlin compared NIH's intramural program to university-based research. What the principal investigators select to study is up to them, although all programs try to respond to national priorities. For example, NIH's history includes both its response to multiple-drug resistant TB as well as the earliest work to identify rotavirus. The extramural research, Dr. Curlin's area, receives 80% of NIH funding. CFS is part of that 80%; if not for Dr. Stephen Straus' interest, much less work might have been conducted to date. Dr. Sawyer added that a Board of Scientific Counselors peer- reviews and advises on the content of the intramural research program.
Social Security Administration (SSA)
Ms. Carolyn Kiefer reviewed three of the Social Security Administration's initiatives. SSA has had written policy guidelines since 1988. These address both specific policy questions and general guidance for the agency adjudicators who determine disability claims due to inability to work. Early this year, the agency began a Social Security Ruling on CFS which will be binding on all adjudicators and Administrative Law Judges (AU). SSA is working with The CFIDS Association of America to ensure that all points of policy are addressed and up to date. This will be released to all AUs and adjudicators of agreement on the final text. The ruling will ensure that the policy is uniform for all adjudicators from the initial claim onward and is hoped to reduce the current number of appeals.The CFIDS Association and Dr. Paul Levine also helped SSA to identify physicians to facilitate independent medical evaluations (IME). These physicians can advise SSA about other physicians cross-country who are knowledgeable and willing to work with the agency, and perhaps to do individual claimant exams. A list of these physicians is being compiled and will be distributed to all state agencies for use when more information is needed on medical claimants. Finally, Ms. Kiefer reported the third initiative, which involves a CFIDS Association- proposed hour-long training video. The proposal appears to have merit for AU use, and a funding mechanism is now being pursued.
Discussion of SSA Report
Dr. Schweitzer asked if the SSA list of diseases not requiring a burden of proof now includes CFS. Ms. Kiefer answered no, as yet, because the manifestations of CFS are so variable and involve overlapping disorders. This may be possible later when research can better characterize the disease. Dr. Schweitzer suggested at least listing the narrow CDC definition as sufficient proof. She also urged that the preliminary investigators' level of information be matched to that of the AUs. Ms. Kiefer acknowledged that an SSA review found a number of cases in the appellate levels which should have been allowed by the preliminary investigators. SSA hopes that the planned policy directives and training will help to correct this. However, regarding the disease listing, she expected that SSA's traditional method of operating would prefer to wait before announcing a listing until all a disease's aspects are sufficiently addressed by the general medical community.
Dr. Komaroff noted that CFS patients are challenged to sustain mental or physical activity over the course of a day. He asked if the SSA techniques are adequate to measure that, or if research is underway to do so. Ms. Kiefer reported an SSA drive to ensure that their adjudicators understand that fact, and thought that preliminary steps were underway for further research regarding CFS patients' functional restrictions. Dr. Natelson may propose research on that; however, mechanical and institutional steps are necessary before that can be finalized.
Food and Drug Administration (FDA)
Dr. Marc Cavaille-Coll described FDA's mission of evaluating new therapeutic agents for safety and efficiency. Since the time was short for their report in this meeting, he provided a written description of the drug review process and FDA's action plans for FY98. The FDA drug review teams which review investigational new drugs (IND) are multidisciplinary and diverse in scientific and regulatory areas. FDA works closely with sponsors of therapeutic drug agents in the review process.Specific to CFS, Dr. Cavaille-Coll reported no new IND applications for CFS in FY97 or FY98, but they are working with existing INDs. In May 1997, FDA allowed an open label study of Ampligen for use by those with seriously debilitating CFS. More such patients will enroll in FY98. The manufacturers of Ampligen announced clinical trials to support approval for its drug development cost recovery application. In addition, FDA maintains its involvement with the CFSCC, and actively educates about its function in drug development. It ensures optimal communication between its intemal organizations addressing CFS from various perspectives, and provides ongoing outreach communication through such venues as their home page at www.fda.gov.
Discussion of FDA Report
Dr. Klimas noted that her active IND in biologics was not included in the FDA report, but Dr. Cavaille-Coll noted that the report covered only his Division. He also noted that FDA does not initiate research, it only allows research to proceed. Some research, however, does not even require exemptions, such as the research of lawfully developed drug products for uses not requiring changes in their advertising or indications. So, for example, drugs such as Florinef do not require an IND. Dr. Klimas thought that all Stage I research should be included in the FDA report to the CFSCC. But Dr. Cavaille-Coll responded that FDA intended to report on the number of new applications, and also that INDs are not coded by the specific diseases addressed. If an IND is not designated for CFS, it may not appear in his report, although all FDA Divisions are expected to cross-consult on work that is also germane to other Divisions.
Mr. Crum asked if there are mechanisms to reassure that a drug approved by FDA will be safe for children. Dr. Cavaille-Coll reported FDA's encouragement that drug safety in pediatric settings be investigated as soon as possible, and that children be included in clinical studies. Mr. Crum asked FDA's relationship with researchers when it sponsors a clinical trial. Dr. Cavaille-Cdll said that FDA does not do research, although there are some NlH-funded clinical trials with which FDA Divisions work (e.g. NIAID's AIDS Clinical Trials Group, or with NCI's oncology research). For example, the FDA Center on Biologics has a significant number of staff working on the NIH campus.
Mr. Crum then asked which agency a small underfunded pharmaceutical company with a promising product should approach to conduct the Phase III trials and produce the data needed for FDA approval. Dr. Curlin said that this would be an NIH function, but also noted that the clinical trial is only the end of a long sequence of events built on animal models, etc. But there are other options for smaller companies to develop vaccines. NIH has such a program; or, they could license the product to a larger firm for clinical trials and release, or pursue other opportunities such as foundation funding if the science base is good and the product gains consensus that the medical aspects, safety/efficacy of the intervention support clinical studies. The latter is crucial in either case, because a big company is unlikely to invest in less-than certain products.
Dr. Schweitzer described an Ampligen trial with 20 person enrolled, whose expansion to 80 more subjects had been delayed. She lamented a situation in which a product, of apparent benefit to some and without evidence of harm to anyone, is controlled by the patent holder, who can withdraw it from trials due to underfunding, even if the patients needing the product are willing to pay for it. Dr. Cavaille-Coll responded that unfortunately, without a drug sponsor's permission, FDA cannot discuss any specifics about clinical studies. However, since it had been publicly announced, he could confirm that FDA had approved the enrollment of additional subjects. While he could not say more, he agreed to the importance that controlled studies be done as quickly as possible, to demonstrate whether or not the beneficial changes seen to date are attributable to the drug or to a placebo effect. Uncontrolled studies done over time may allow too many people to try an investigational drug without knowing if it will help them or harm them, a problem that was recognized with AIDS which FDA is now trying to avoid. However, who the company chooses to enroll in its controlled study is their own decision.
Health Resources and Services Administration (HRSA)
Dr. Carol S. Gleich briefly updated the committee on the Health Resources and Services Administration's (HRSA) activities. She first recognized Commander Nanette Pepper, HRSA's CFS Coordinating Officer, for efforts which resulted in a meeting between The CFIDS Association (Ms. Kenney) and HRSA's Bureau of Primary Health Care (BPHC). As a result, it was proposed that a letter from HRSA's Bureau of Primary Health Care (BPHC) Director, Dr. Marilyn Gaston, be sent to the Community and Migrant Health Centers nationwide, including information from The CFIDS Association of America. She also arranged for staff of HRSA's Maternal and Child Health Bureau to attend the previous day's workshop.The CFSCC meeting book contained a description of the last six months' work on the demonstration project of the CDC Public Health Training Network national teleconference sponsored by The CFIDS Association and HRSA's Area Health Education Centers (AHEC). The conference was outstandingly led by the Illinois AHEC. The AHEC-CFIDS Association collaboration with CDC's Public Health Training Network (PHTN) established a community- based model for all communities.
The now-improved links between the AHEC network centers and communities facilitated increased awareness and knowledge of CFIDS, and provided better opportunities for education of health professionals, students, etc. The conference included 108 downlinked AHEC sites in 25 states, and over 1,800 attendees. Half of the latter were physicians, the others health professionals, students, and 300 CFIDS patients or other interested parties. The videotaped conference was rebroadcast later in several areas, and is available from AHEC libraries. This demonstration project cost was estimated at [less than] $25/participant. Most AHECs indicated that more marketing lead time (at least a year) would have greatly increased participation. Local CFIDS support groups now accept the AHECs as a new community resource, and interaction has increased.
Feedback on the conference included praise for its technical quality but criticism for the content as insufficient for diagnostic purposes. Some thought it overly lengthy, offered at a bad hour for primary health care providers (the AHEC's main constituency), and insufficiently addressing diagnosis and management of CFS. This also may indicate that primary care providers receive little information on CFS in their training programs.
The AHECs are reportedly eager to participate in such future conferences serving national health care priorities. Since continuing education credit was offered only to physicians and nurses, measurement of outcomes is difficult. However, most AHEC centers felt this to be only one manner of outreach, and it was the first experience with satellite technology for several. The CFIDS Association mobilized with local AHECs to market the conference. The AHEC respondents were very positive about the patient interviews used in the conference, and thought they should be the opening and closing spots.
In future work, HRSA will look into the status of the BPHC mailing on CFS; and the National AHEC Program Office will confer with the CFIDS Association about the next step in CFIDS education. This could launch self-administered education modules in CFS for primary health care providers.
Comparison of Gulf War Syndrome and CFS
Presentation of Department of Veterans Affairs (DVA)-Funded Gulf War Syndrome Research
Dr. Benjamin Natelson commented that media reports of Gulf War Illness (GWI)/Gulf War Syndrome (GWS) and its similarity to CFS precipitated their application for a research grant. The grant was awarded to them as one of three Environmental Hazards Centers focusing on GWI. They address the research question of whether Gulf War veterans with complaints of severe and long-lived fatigue and of chemical sensitivity fulfill the case definitions for CFS and/or Multiple Chemical Sensitivity (MCS).The Center sent detailed health questionnaires to 1945 randomly selected veterans on the Department of Veterans Affairs' (DVA) Gulf War Registry of veterans from ten eastern states. The preliminary results indicated that 34% of the evaluable respondents reported symptoms consistent with CFS, of which 16% had no attributable medical illness to explain their CFS-like fatigue. Of the 1945 veterans, 13% reported sensitivity to certain chemicals and resulting lifestyle changes; 33 of the 1945 self-reported both CFS and MCS. If the early 1988 CFS prevalence numbers are projected to 1994, the apparent incidence of CFS in civilians seeking health care is 0.5% to 1%. The higher nature of this study's findings supported a study to see if the Gulf War veterans fit the case definition, and if so, if something in the Gulf precipitated cases of CFS.
To determine actual diagnoses, the study used the DVA registry to target Gulf War veterans living near the Center, as well as to identify those with major symptoms of fatigue and/or chemical sensitivity, and a comparison group reporting good health. They mailed 4898 deliverable screening questionnaires to the targeted Gulf War veterans; 2044 were returned, and 1312 of these were excluded for medical or psychological diagnoses, head trauma, etc. Also excluded were those aged over 57 years because they may have covert medical illness, those with insufficient criteria, or those disinterested in participating. Three hundred twelve (15.3%) were healthy. The study contacted the 420 who were found to be sick. Of those, 240 came to the VA for an exam, 48 canceled or were no shows. and 8 are still scheduled.
Dr. Natelson noted that 2850 veterans who signed up on the DVA Registry with major complaints did not return the screening form, and [over] 50% of the 480 vets who did return it, and who apparently had CFS and or MCS, did not want further evaluation. These numbers are similar to those encountered by Dr. Buchwald's study. He asked the meeting attendees, if they knew any veterans who might wish to participate in the study, to simply call 800-248-8005 to enroll.
MCS does not have a case definition, but they found it to be not as severe in the veterans as in non-veterans reporting this problem. Therefore, the study is using a more liberal definition, in which new onset of chemical sensitivity produces symptoms in more than one organ system, and produces avoidant behavior in more than one sphere (originally they wanted three avoidant behaviors).
The physician evaluations to date found 59 veterans with CFS (17 of whom had concurrent MCS), 11 veterans with idiopathic chronic fatigue (ICF), and five with MCS, totaling 75 veterans with fatiguing illness. Sixty-four study participants were healthy. They excluded 51 who failed to meet some parts of CDC's criteria. They concluded that Gulf War veterans fulfilled the case definitions of CFS, and that CFS can be comorbid with MCS, but cases of MCS alone are rare.
The research tactic was to use the same intake criteria (i.e. "severe CFS") to define groups of Gulf War veterans and civilians, and then to compare them after evaluation. "Severe" CFS was defined as a case that is physician determined, and fulfills the 1988 case definition with some modifications. Only seven symptoms were required, and the severity of at least 7 symptoms, rated from 0-5 on a Likert scale, must be reported as substantial (severity of [3 or higher]).
The same intake procedure (questionnaire) and medical evaluation was done for both civilians and Gulf War veterans. The physician would discuss with the veteran their activity prior to the current illness, and develop a number which the physician agreed would represent a decrease in activity. The physician then collected data on symptom severity to allow an independent study diagnosis of "severe" CFS.
Dr. Natelson summarized the comparative data between the Gulf veterans and civilians.
Regarding outcomes after the physician evaluation:
Discussion of Gulf War Study
Dr. Klimas asked the number in the two groups and Dr. Natelson summarized 62 Gulf War veterans and a varying number of civilians (from 29 in the study focusing on severity to 95 focusing on gender and days of work missed). Dr. Klimas asked how a 46% disability rate could have only 15 days lost from work per year. Dr. Natelson was unsure if this was confined to individuals working; this is a question on the Functional Surveillance Questionnaire. And, although these were all veterans and not active duty personnel, Ms. Thorson noted that it is more common for the military to go to work than not.
Mr. Hennessey stated that he had suggested the GWS/CFS link for seven years, and had proposed the use of the antiviral Ampligen for the soldiers. Had this work been done among the soldiers, it may have promoted acceptance of therapies, improved the insurance industry's coverage of CFS treatment, and saved lives over the years. He saw this as one case in which the agencies could have benefited from listening to the public. Dr. Schweitzer commented on the unknown nature of CFS prevalence. She also suggested that a potential similarity between rates of "severe CFS" and recovery rates might be attributable to the identification of those who are ill, with civilians are not being identified.
Presentation of CDC Research on Gulf War Syndrome
Dr. Reeves noted similar conclusions between CDC's epidemiologic examination of the two conditions and Dr. Natelson's study, achieved through completely different strategies. He described the similarities between CFS and the illness, or group of poorly defined illnesses, affecting many Gulf War veterans.Dr. Reeves summarized the CFS case definition as an illness characterized by profound fatigue of [6 months or longer], differing from that following exercise and unrelieved by rest. It also includes neurocognitive symptoms, musculoskeletal pain and flu-like symptoms. It substantially reduces patients' ability to work, interact socially, or engage in recreational activities.
Almost 700,000 U.S. troops were deployed to the Persian Gulf between August 1990 and June 1991. Dr. Reeves charted the various deployment periods, which are pivotal to the associations with disease, and which involve different seasonal and military exposures. Depending on their branch of service and duties, the 83% of active duty personnel and 17% of Reserves/Guards all risked different exposures.
The most common symptoms reported by the 10,391 Gulf War Veterans in the DVA Gulf War Veterans Registry participants are fatigue (29%), headache (22%), joint pain (20%), muscle pain (16%), difficulty remembering (15%), and sleep disturbance (10%). The Gulf also presented some unique health problems such as viscerotropic leishmaniasis, but no single illness or pattern of diagnosis has been identified to affect the large number of sick veterans.
Where Dr. Natelson explored for CFS and CFS-like symptoms, CDC looked only for a cluster of illness. Dr. Reeves described the study's strategy of surveying the 193rd Air National Guard Special Operations Group and three other Air Force units in Pennsylvania and Florida. The study sought to determine if
Dr. Reeves noted the impossibility of studying a collection of 35 symptoms which virtually everyone experiences. The survey's goal was to create a case definition, which must separate those symptoms which define an illness from those which simply accompany it. CDC developed two case definitions, one from a common sense approach, and one statistical. The two were compared to select a final definition.
The common sense approach assumed that if Gulf War Illness (GWI) existed in 1995, it must be chronic, so symptoms had to be present [at least] 6 months. If participation in the war was an important risk factor, at least 25% of veterans should report the core symptoms, and defining symptoms should be at least three times more common among veterans than the non- deployed.
Factor analysis, often used to identify core symptoms, was used in the statistical approach to identify case-defining symptoms. This is a purely mathematical method, independent of clinical reasoning and avoiding the assumptions of the common sense approach. It used data from both Gulf War veterans and the non-deployed.
Dr. Reeves noted the virtually identical results of the two approaches. Common sense defined an illness that included fatigue, a variety of mood and cognition related symptoms, and musculoskeletal related symptoms. Factor analysis showed the same things, but provided more symptoms with which to define all three.
The analyses enabled a CDC definition of Gulf War Illness. It includes at least one chronic symptom (present for 6 months or longer) for two or more of the following categories: 1) fatigue; 2) mood and cognition related symptoms; and 3) musculoskeletal symptoms. That definition is very similar to that of CFS, except that fatigue need not be present for GWI, which also excluded severity criteria (inability to work, socialize, etc.). GWI also includes significantly more neurocognitive symptoms, and GWI did not include the flu-like symptoms inherent to the CFS case definition. Another difference between the two is that the CFS case definition was developed by a consensus of experts based on clinical experience; the GWI definition was empirically derived by statistical analysis of population-based data.
Dr. Reeves then addressed the risk factors for GWI. Again, the epidemiologic associations of GWI may relate to those of CFS. Overall, 45% of Gulf War veterans met the case definition, but interestingly, 15% of the non-deployed also fit it, a high degree of correlation. Gulf War veterans were sixteen times more likely to develop severe as opposed to mild or moderate GWI. This was also three times more likely among females and two times more likely in smokers than nonsmokers. CDC found that specific placement, duties, branch of service, etc. was not pertinent; the basic problem was simply being present in the Gulf during the war.
The data were then compared to that from the June-December 1994 random digit dial survey on fatiguing illness conducted in San Francisco. The respondents were categorized as to CFS- like illness and GWI. Interestingly, the 12% of San Francisco population which met the CFS case definition paralleled the initial analysis' 15% match among the non-deployed veteran population. The rates of CFS-like illness also were virtually identical in non-deployed military and civilian populations.
CDC also conducted a clinical evaluation component in May 1995 among 158 members of the 193rd Air National Guard. All the studies were blinded for clinical classification, but a later analysis found 13 with severe illness, 86 mild/moderate, and 59 healthy. All the subjects completed a functional disability questionnaire, and had a clinical evaluation which included a standardized physical examination; blood, urine, and stool laboratory analysis; and were screened by the DIS and for Post-Traumatic Stress Disorder (PTSD). The study found no abnormalities in the physical exams or laboratory results, nor any association with an infectious agent, but it did find significant decreases in functioning and well-being. However, the clinical evaluation again highlighted the similarities between GWI and CFS. Eight of the 158 volunteers were diagnosed as having CFS, most of whom were among the severe cases of GWI.
Dr. Reeves summarized that substantial numbers of Gulf War veterans suffer from an illness characterized by muscle fatigue, neurocognitive disorders, musculoskeletal pain, etc., but they do not have physical signs or laboratory markers. The CDC study of Air Force Gulf War deployed and non-deployed veterans defined an illness similar to CFS, differing with respect to severity of fatigue and the absence of some symptoms. Though present in both veterans and non-deployed, the illness was 4- to 16-times more common among veterans. The rates of illness were also similar in the non-deployed Air Force and the civilian population of San Francisco, demonstrating that the illness is not unique to the Gulf region. Finally, there were no assQciated physical signs, laboratory markers, or associations with an infectious agent, but significant decreases in functioning and well-being were found. More than half the severe Gulf War illness veterans evaluated met the criteria for CFS.
Discussion of CDC Study of GWS and CFS
Dr. Komaroff complimented CDC on its case definition. He asked if, like the lab tests, the psychiatric assessments did not correlate with GWS cases. Dr. Reeves confirmed that, although there was some overlap with PTSD, CDC also found, as did Dr. Natelson's study, a low frequency of sudden onset cases. Almost all were slow. Dr. Klimas asked what lab markers were used. Dr. Reeves reported that immune function tests were not done, but those for CFS were (stool samples, SMAK 20, urinalysis, etc.), after which more detailed tests for antibodies were done. Detailed genetic studies will be done.
Ms. Kenney noted that the similarity between CFS and GWI had been removed from the current CDC information booklet on CFS. Dr. Mahy said that this was done because no peer- reviewed publication currently supports it. But Dr. Klimas noted that the VA included it in their material, since their position is that GWI is chronic fatigue. Dr. Reeves also confirmed for Ms. Kenney that CDC hopes to have a related research paper published in the Journal of the Amencan Medical Association (JAMA) after one more revision.
Noting the high percentage with musculoskeletal problems, Ms. Thorson asked if the Gulf War cohort was examined for FMS. Dr. Reeves responded that the questionnaire explored specific symptoms (e.g. muscle pain), not specific tender points. Ms. Thorson asked further if CDC thought presence in the Gulf to be a triggering risk factor. Dr. Reeves noted the presence of the illness in non-deployed Air Force veterans as well, but at a greatly reduced incidence.
Ms. Kenney asked if there were any data on the large numbers of civilians present in the Gulf from the media, health care personnel, etc. Dr. Reeves answered that CDC's primary focus was on the military, which would include most of the health care workers. However, the disease was not greatly reported in the coalition forces, except that now the British are looking into it.
CFS Information and Education
Physician Education
Ms. Kenney stated the high priority assigned to physician education by The CFIDS Association due to its immediate impact on patients' lives. To broaden these educational opportunities, the Association suggested four priorities for the CFSCC: improving the illness' detection, diagnosis, and management, and changing provider attitudes about the illness. She asked for broader discussion of potential recommendations to the Secretary on further activities which could build on the start made by the satellite conference.Dr. Mahy commented that the least expensive outreach would be through a brochure, and asked what NIH had for physicians. Dr. Curlin reported that their brochure for physicians is on the NIH Web page. But while brochures are inexpensive and valuable, it remains a challenge to get people interested enough to find such materials. The NIH brochure's popularity is due to its promotion by patient groups. He suggested that experts on mass media be involved to advise how to excite attention, because that will not automatically happen.
Dr. Klimas summarized three levels of physician training:
Since both rural and urban physicians access CDC's Web page, Dr. Klimas thought that a CME course offered through the Internet would be attractive. Mr. Heiman reported that the AMA homepage allows physicians to register, which would be helpful tracking information.
Ms. Kenney wondered how the Increasing interest of physicians evident at meetings could be translated to better care in small home towns of patients. Dr. Klimas thought part of the answer to be a presence at small meetings attended by such small-town physicians, and to arrange CMEs in ways not requiring travel (e.g., CD ROM, videos, etc.). The information given should be simple and to the point, and reward the physician for his/her attention (e.g., the DVA magazine allows CMEs for the completion of a short quiz on each issue's content).
A member of the audience commented that rural doctors are not Web users for applications other than billing and insurance filing. But another urged sponsor support of Web courses (i.e., "CME-lite") which are only 1-2 hours. Mr. Crum also raised the patients' motivation, many of whom are Web savvy, and who can educate their physicians. He thought the CFS education process would most likely include all the avenues mentioned.
Dr. Reeves stated that CDC's booklet and all its current literature for physicians will be on the Web. Ms. Thorson suggested issuing a one-page pamphlet summarizing the NIH booklet's information. Dr. Schweitzer also raised the disinformation that physicians receive from the media. The need to unlearn such information is not usually taken into account by education programs.
Ms. Sarah Bass, President of the Connecticut CFIDS Association, noted that many symptoms associated with CFS are not listed in the CDC brochure; only fatigue and four others. The NIH brochure is more helpful because it lists the current CDC definition as well as other symptoms which vary between patients (e.g., visual disturbances, night sweats, balance problems, irregular heart beat, etc.) This has been very helpful to physicians and patients in Connecticut and helps to counter such disinformation as that published in a syndicated medical column that eye problems are not attributable to CFS.
Discussion of the AACFS Conference
Dr. Komaroff announced the Fourth International Conference on CFS to be held October 10-12, 1998. The first day's agenda is for research presentations, dialogue, and evening meetings of scientists in particular fields to discuss methodologies. Day 2 is for practicing physicians to address the real issues of patient care; and Day 3 will describe the outcomes of days one and two and address CFS patient issues such as disability, medical care, etc. It will be held in Cambridge, MA, at the Hyatt Hotel. Information is on the Internet at the MCFS website.Dr. Klimas suggested having the next CFSCC meeting after that conference. Dr. Curlin appreciated the opportunity for the CFSCC to learn about AACFS, and to have the benefit of the scientific meeting. But he was unsure what constituency groups and agencies (aside from NIH) would attend. However, other members expected that most of the constituency groups, at the least, would be in attendance; scientists from NIH; and CDC planned on being there. The discussion was carried on outside of the formal proceedings, and the final decision deferred to the end of the meeting.
Analysis of Distance Learning Teleconference
Dr. Paul Levine summarized the experience and outcomes of the CFS Distance Learning Conference. Aside from reaching the attendees, CDC tried to make the proceedings as available as possible to all the disciplines (e.g, publications in Clinical Infectious Disease, Journal of Psychiatric Research). The American Journal of Medicine will publish an extensive description of the conference, which will also be on the Internet; and the American Journal of Rheumatology is also interested. Dr. Levine expected that many health care providers, regardless of their specialty, will be interested in CFS. Dr. Gleich agreed, recalling that the greatest number of participants at the Parklawn downlink were nurses.
Review of an Approach to the Current Disease Name
Dr. Mahy summarized the clear unhappiness among CFS patients with the disease name. However, the difficulty of changing it includes the absence of new information or a commonly accepted eponym, potential confusion in the literature, and the fact that diseases are not generally named by committee. However, the continued interest in discussing this prompted its inclusion of the meeting agenda.
Statement by Roger Burns
Mr. Roger Burns, the publisher of the CFS-NEWS Electronic Newsletter, stated his support both of science's principles on name-change issues, and of a name change to end the stigma associated with CFS. He had testified to Congress and conferred with the Surgeon General on these issues.Since the CFSCC's determination that a physiological basis for a name change was premature, the use of an eponym is more likely, and he surveyed CFS patients in this regard. Almost 92% supported a name change from CFS, 72% would support an eponym, and 15% would wait for the scientific name. A little more than 80% identified stigma as the main reason to change. Half the respondents felt the stigma of the disease to be the same or less, 14% thought it had increased, and 22% did not know. A strong educational campaign to accompany the announcement of a name change was supported by 88%, and 87% supported formation of a joint panel of scientists and advocates to select the name. Specific eponyms on which the respondents voted (drawn from suggestions on previous surveys) were Melvin Ramsey, Alexander Gilliam, William Osler, Daniel Peterson, David Bell, Paul Cheney, or Florence Nightingale.
Mr. Burns stated further that he was impelled to demand a name change by his personal communications with CFS patients. He read a sampling of the comments sent to him. Paula [Freghetti] of Arizona thought that waiting to change the name was unethical, showing neither understanding of nor compassion for the situation. Michelle Bevin of Florida cited all her losses (family, friends, career) and her extreme frustration at having the illness perceived as something she caused herself rather than one of physiological origin. She stated that the name, trivializing CFS patients' predicament, is the root of an ongoing battle which defeats even the chance of the contributions that CFS patients still could make to society, even while ill. Kathleen [Barto] of California had been sick since 1984, before the name was chosen. She felt that changing the name might enable some CFS patients to regain some self-sufficiency. Some contemplate death as a release. Mr. Burns' final related statement was excerpted from an Internet message from Joan Irvine, reacting to the assisted suicide of Judith [Currin] and resulting media reports characterizing CFS as trivial. Ms. Irvine discussed her own agony of living with CFS, and shortly thereafter took her own life. Dr. Schweitzer added that changing the disease name was critical [in Ms. Irvine's suicide note].
Mr. Burns called for much more communication between all those interested in CFS. Patients feel that the CFSCC could change the name, and in fact, DHHS staff had told him that as well. Scientists also need to write about and communicate to the patients the difficulty of the ignorance they face in this critical work.
Mr. Burns urged everyone involved in the name change debate to adopt the broad view that the real issue is the stigma, not the name itself. The patients feel that simply announcing the name change would be a major step in legitimizing the disease. At the least, they have requested that the CFSCC involve the Surgeon General in making a major announcement about the legitimacy of the disease. The incremental progress made on CFS is important in legitimizing it to those paying attention, but not to the average physician and public. A dramatic announcement could help, backed up with educational materials for physicians wanting more background. He suggested that an ongoing committee be formed to address this with the Surgeon General, giving it more attention than is possible through a twice-yearly CFSCC meeting.
Finally, Mr. Burns read a list of questions which should be discussed about changing the disease name:
Mr. Burns concluded that this general process will at minimum help to reduce stigma and pave the way for a name change. He stressed the importance that this committee's rationale about the disease name be very clear and speak to the patients' needs.
Discussion of Changing the Name
Dr. Mahy commented on the issues raised. First, he felt that the disease under its present name is legitimized by the existence of the CFSCC, which is chaired by the Surgeon General, who would be made aware of this problem. Second, he noted that the disease is not national but rather international in scope, and that diseases are usually named by the global scientific community as whole. Third, he thought it would be a mistake to make any move that could jeopardize the current support and funding for CFS research by focusing on variations (e.g., a suggestion was voiced on the previous day to drop the sometimes-used "immune dysfunction" terminology), and an eponym unrelated to the disease could actually do harm. Next, he focused on Mr. Burns' main point of the need to make a major impact, which in many ways he thought was almost accomplished. He did not expect difficulty in obtaining needed support, such as was obtained from Dr. Lee in setting up this committee. Finally, he noted that on March 24, the CFIDS Association had issued a statement that all aspects of the name change should be considered. Ms. Kenney provided copies of their Board of Directors' statement. She agreed that there are no easy answers to this question, even though all agree the name should be changed; the question is, to what?
Mr. Crum said that like it or not, people do make assumptions based on names. While he appreciated Dr. Mahy's points, the same may be true in five years as now. The workshop made apparent, and the upcoming AACFS points to, a good deal of information and a very positive momentum. He suggested this issue be re-addressed at the AACFS meeting, and then again in the next CFSCC meeting. He has struggled himself with the associated priorities, made the more poignant by personally knowing someone without access to the best care who is getting sicker. He was beginning to think that the time might be right this year to build upon the current momentum.
Dr. Klimas saw no conflict in continuing the discussion of a name change and concurrently issuing a public statement. The latter could be done in conjunction with the earlier suggestion of a report card on the field's progress, perhaps in a press conference at the next meeting. This would raise the importance of the name change controversy. Dr. Mahy thought that appropriate, couched in the context of the AACFS conference.
Dr. Reeves suggested that the committee consider revision of the case definition, of which the name change would be a component, and perhaps the crafting of a clinical definition. This discussion would also be a good topic for the international conference, as a more substantive discussion which could further research and put the name change in a proper perspective. CDC is exploring reconvening the case definition meeting, so perhaps a beginning could occur at the AACFS conference. A case definition review is of interest in the scientific field, and with the entry of Gulf War-type illness crosses out of DHHS areas of focus to include to DVA, DOD, and other agencies.
Mr. Albert Donnay, Executive Director of MCS Referral and Resources, reported a related consensus and research planning conference at CDC scheduled one month before the AACFS meeting. It will address multiple chemical exposures, MCS, and "related disorders" among Gulf War veterans. The proposed meeting agenda was in the CFSCC meeting packet, along with a report from Assistant Secretary Eisenberg which clearly supported placing CFS on that agenda as well. If this process began at the CDC meeting, it could continue in Boston.
Ms. Vicki Walker, of The CFIDS Association, reported a greater media response to their announcement about the previous day's workshop than anything released previously. She felt that there is enormous support among the media as well as the medical field, and she strongly supported the idea of a CFSCC press conference. Mr. John Sterling, President of the New Jersey CFIDS Association, also suggested that the CFSCC could appropriately recommend the development of a PSA on CFS to the Surgeon General, as was done for such other conditions as Lyme Disease, AIDS, and lung cancer.
Mr. Burns appreciated the idea of a CFSCC press announcement to legitimize CFS as a serious illness. But he also thought that the public would assume that the CFSCC is constituted of government employees whose livelihood is based on promoting CFS, rather like the dairy industry saying that milk is good for you. He thought that this statement would be more effective from the Surgeon General.
Dr. Curlin pointed out that although the downside of the name is clear, it also could be an advantage in that it is memorable. He added that in reality, disease names get changed through usage; when a name is used in publication, it is used in discussion. Therefore, it is incumbent on the field to start creating the language.
Dr. Curlin also stated his opinion that wedding GWS to CFS is a very serious issue bearing discussion. Although he appreciated the information provided about GWS and its symptomology, he was not at all ready to link the two conditions. This research is at a very exploratory stage, and he urged the CFSCC members not to promote merging those issues. As a DVA physician, Dr. Klimas endorsed that, particularly in the absence of data. She added that the data presented on this day about acute versus insidious onset had unnerved her even more about merging the two without a better understanding of both. On the other hand, she acknowledged that there are political advantages in linking the two, such as the sympathy for Gulf War veterans not usually afforded to CFS patients.
Presentation of the Scientific Session on CFS in Adolescents
Dr. Komaroff reported on the scientific session held on the previous day. He noted several underlying themes broader than the focus on CFS which emerged from that session. One was the difficulty of understanding any illness in children as opposed to that in adults. The point was repeatedly made that children are not simply little adults; they have different and less experience, and living in a different social context. In particular, their family context can dictate how they understand and deal with illness. It was also noted that pre-pubertal children are not just little adolescents. Children of different ages differ in how they suffer and express that.The scientists voiced no doubt that CFS is real in children. Although it is rare in those under age 10, it is not rare in adolescents. Studies by both CDC and Dr. Jason's group at DePaul University indicate a prevalence of one in 1000 in adults and 1 in 2000 in teenagers.
Another point raised in the scientific session was that, as is true in adults, the degree of debility among children is very variable. Some children are ill, but can lead reasonably normal lives. But there is also clearly a subset of children (e.g., in Dr. Smith's study) in which those most severely affected miss an average of 10 days of school per month. In two other study populations, 20% of children with CFS required home schooling over several years, or could not even be home-schooled.
Some differences of opinion were voiced at to whether CFS symptoms present differently in adolescents than in adults. There was no consensus reached in this matter. Most of the scientists seemed to feel that there is no dramatic difference in symptomology. One clearly definable opportunity for measuring adolescents' degree of debility, as suggested by Dr. Marshall, was through school absence.
Dr. Bell presented a 15-year longitudinal study of a group of pediatric CFS patients whom he first identified in the mid-1980s. Nearly 40% reported recovery to completely normal health, on average in about four years. Another 40% were basically but not completely well, still experiencing symptoms but functional. So the good news was that 80% of these patients were in nearly normal health after 15 years. The bad news was that 20% were still ill. Dr. Feder also reported on a follow-up study conducted with similar results.
One research problem shared was the challenge in collecting information on functionality from patients. For example, one former pediatric patient who is now a young adult described himself as completely recovered, but also described his daily existence as bedridden.
Laboratory studies were also presented. Dr. Rowe and Dr. Stewart discussed their studies of autonomic nerve system function tilt table testing. Among a highly selective group of children, about 80-90% of the children showed abnormal results. However, in Dr. Rowe's larger study on Florinef, the frequency of abnormalities diminished to about 60%. Other researchers reported finding no such abnormalities, but this may be due to different techniques for testing.
One anomaly was reported by Dr. Rowe, who found a surprisingly high frequency of a rare congenital disease, the Ehlers-Danlos syndrome, in children with CFS. About ten of 200 children with CFS fit that disease definition, and another group had a mild form. The physical abnormality in soft tissue in Ehiers-Danlos syndrome allows blood pooling and therefore hypotension.
Dr. Jones noted the inconsistency of the literature on immunologic abnormalities in CFS, and reported three abnormalities which he found in children: an elevated tumor necrosis factor, a depressed interleukin 10 level, and an increased ratio of memory to naive T cells. Dr. Demitrack and others discussed hypothalamic pituitary axis hormone studies, although these have not been conducted among children.
The conferees discussed several areas of possible research in children with CFS: whether the adult case definition requires revision; and if so, whether that process for adults should be paralleled by one to examine a case definition for children. Another area of potential research is the effect of the family dynamic on sick children, both of the parents' and siblings' effects on the child, and of the illness itself on the family.
Clinical trials of various treatments were also discussed, with several suggested, but no specifics were provided on what trials should be done or who should fund them. Regarding laboratory studies, there was some discussion of which areas which have informed adult CFS should be more aggressively studied for children: tests of the immune system (selected humoral or cellular immune tests), neuroendocrine tests, or neuroimaging tests with a variety of techniques to examine the function of the brain and peripheral nervous system.
Discussion of Program on CFS in Adolescents
Ms. Thorson appreciated Dr. Komaroff's opening statement that CFS in children is a very real problem, and appreciated his advocacy for CFS patients. She felt that while a preponderance of the scientists agreed that pediatric CFS is a real problem, she was disturbed at the degree of statements attributing it to psychological and psychosocial causes. She was particularly disturbed by a reference to CFS as a "learned illness." She said that Dr. Carter included the caveat that not all is known and an open mind is warranted, other presenters seemed to think otherwise. She was concerned that comments about psychological aspects risked reinforcing persisting misperceptions that the disease is imagined, and was shocked to hear it referred to as a "learned illness."
But Dr. Klimas disagreed, citing the presentations of studies finding fully half of CFS-like illness is not explainable in any other way than the syndrome. Dr. Komaroff commented that the two papers by Drs. Bruno and Carter agreed that the conventional psychiatric illnesses do not explain CFS in children. However, some scientists do have a tendency to dismiss viewpoints if they include contradictory data. In his opinion, there are sufficient objective markers to indicate the biology of CFS.
Dr. KImas raised the importance of the meeting's discussion about whether the pediatric CFS case definition should be addressed, and on the psychometric scientists' concern that accurate symptom measurement consider the child's age and situation. While controversial things were said, she thought them to have been well countered by most of the others on the panel.
Dr. Gary Marshall said it is accepted that CFS is real in children. What needs to be emphasized now is the impact of CFS disability in children versus adults. He suggested that a month of missed school, socialization, etc., has more impact in adolescent development than an adult's month of part-time or missed work. The conference emphasized that the life of an adolescent is dynamic in the lineal ascent from child to adult, and this greatly impacts the passage of time.
Another perspective represented at the workshop was that of the spectrum between a simple medical or a simple psychological model. It is clear that the two cannot be separated, but the interplay between the two is also difficult to define. While it cannot be denied that studies show prevalent psychological and physical co-morbidity, this remains a chicken-and-egg relationship that must be defined.
Dr. Marshall was unsure that the case definition needs to be changed, but it certainly should acknowledge the occurrence of the syndrome in children and adolescents. No official documents on CFS address that fact. Considering cases with symptoms maintained for six months will allow a greater specificity of prevalence in adolescence, as that length of time leads to the most severe cases. Adding school attendance as a measure also will increase specificity, although it may be at the cost of some sensitivity.
Another issue raised was of the natural history of mononucleosis in CFS histories noted by the clinicians treating these patients. The natural history presented by Dr. Buchwald related how those who had EBV with related mononucleosis did not recover for a long time. This requires further research.
In relation to the name change controversy, Dr. Marshall cited the example of AIDS, perhaps the most stigmatized disease in modern times. Its name defines it scientifically as an acquired immune deficiency syndrome, even though it encompasses other problems such as neurological complications and wasting. Dr. Marshall felt that simply changing the name of the syndrome will not affect its stigma; only solid research data and education will do so.
Finally, for his summary of the workshop for publication, Dr. Marshall described his initial plan of writing a comprehensive review incorporating the conference's new data presentations and discussion. He would target for publication the Journal of Pediatrics, the most highly respected academic pediatric journal, although he was unsure how many general practitioners read it. The need for this article is certain. Dr. Marshall noted that the last related one published in Pediatrics, which tends to be read more by generalists, opposed diagnosing CFS in adolescents. Dr. Julian Stewart, of New York Medical College, added that article was extraordinary, in part because it offered almost no data.
Public Testimony
Written testimony by the public is available online at the Index of Public Testimony at the April 1998 CFSCC MeetingsMs. Emilie Sutterlin, a 15-year old CFS patient and freshman in high school, rhetorically asked how a family physician could advise her on what exercise she can do in the context of a high school physical education. The contradictory advice to CFS patients must be resolved. Some books advise them to do more than they think they should, only that much, or less. A British report supported graded exercise, but was criticized by some as being incomplete and biased. Ms. Sutterlin stated that she already has low blood pressure (73/50) and a resting pulse of over 100. There are no data on why exercise exacerbates her condition; her exercise tolerance level has varied greatly. She advocated expanded federal support for research on the patterns of effects of exercise on CFS patients, including the effects on the degrees of disability. Many children cannot engage in exercise without directly contradicting their physicians; she quoted supportive evidence from several students her age on their experience. Her physician suggested that CFS youth be considered as indicators of the threat of CFS to society at large.
Ms. Sutterlin's written testimony from the previous CFSCC, October 1997, can be found online at: http://www.geocities.com/HotSprings/5330/hth.htm.
Mr. Albert Donnay, Executive Director of MCS Referral and Resources and the research coordinator of a multi-center study of MCS immunology at Johns Hopkins University, discussed multiple chemical sensitivity (MCS). He had submitted written testimony to the May 1997 meeting about the overlap between and need for screening of MCS, FMS, and CFS. Without such screening, one can never know if the study findings are due to the specific disease being studied or to overlap. For example, Dr. Buchwald's study had found that two-thirds of her CFS cohort had MCS, and he cited others as well. However, data comparison for overlap is frustrated due to differing study methodologies. On the positive side, associations have funded further study.
Mr. Donnay regretted that the CFSCC had not yet suggested that all RFAs include all three conditions, and lamented that NIH wastes over $20 million a year on separate research funding for each. None of these results could be reliably attributed to disorders, because all failed to screen for all three. In his review of the NIH FY97-funded abstracts, he noted that only three discuss screening for FMS; only one FMS study screens for CFS; and none screen for MCS. This is important because in their research among 100 newly-evaluated MCS patients over the last two years, 88% met the criteria for CFS (slightly more men than women, perhaps for the first time), and 49% had FMS (more women than men). But of the 88% with CFS, only half had FMS. He was encouraged that screening for all three is beginning, and asked that the CFSCC consider his recommendation in time for the CDC conference in September. Both cases and controls should be screened as a normal protocol; if that were done in the last year, the research funding for all three would have risen.
Finally, Mr. Donnay provided their study's questionnaire, citing a sensitivity and specificity of 97% and 98% for the MCS questions. He clarified that he did not believe that CFS and MCS were the same as GWI (elements in Gulf War Illness do not fit MCS), but since they could be concurrent in large numbers, the veterans should be so screened.
Ms. Sara Bass is President of the Connecticut CFIDS Association and mother of a 19-year old with CFS. Her daughter was diagnosed at age 14 following mononucleosis, and was bed bound for her last three years of high school. She charged that the DHHS had done next to nothing in the last two years to study or conquer CFIDS, educate the educators, or even acknowledge that CFS exists. This meeting and the satellite conference were a good start. But like a tree falling in the forest, no one heard it; very few in Connecticut attended the conference due to little promotion. A major press conference is needed, held by someone at a very high level, and perhaps assisted by an advertising agency to maximize its effectiveness.
She stated that most physicians in Connecticut, including most pediatricians, are still ignorant of the presentation, diagnosis, and treatment of CFIDS from gradual or sudden onset. Many do not believe it exists, or that it is seriously disabling. She told the story of Steven Paganetti, Jr., who prior to 1986 was a brilliant student on a full scholarship to a private school. He developed an extensive rash (common, but like many other CFS symptoms, unlisted in either the NIH or CDC handbook) and other symptoms. Changing diagnoses and treatments did not help; an infectious disease specialist in a major medical center thought it psychological and told him to "get [his] ass back to school; there is nothing wrong with [him]." A gastrointestinal specialist thought it might be CFS, but that was "out of his area." He was told repeatedly that his illness was psychological in origin even though he passed multiple psychological tests.
He returned to school in September 1996 with a nose tube, and was treated for NMH by January 1997. He collapsed in February, went into shock, and was hospitalized. He has been totally bedridden since in a motorized bed, now with a stomach rather than nose tube, and in constant pain that methadone cannot relieve. The family physician does house calls and coordinates with Dr. Steven Bell, who presented Steven's case to an international conference. The family is emotionally and financially drained. They were just approved for SSA, but that is inadequate. She urged the CFSCC to remember Steven, who would not be so disabled were he appropriately treated early, and to prevent such occurrences in others.
Ms. Bass' full testimony can be read online at: http://www.cfids-me.org/cfscc/bass0498.html
Ms. Jill McLaughlin of the National CFIDS Foundation has a 15-year old daughter named Amy who has been sick since age 8-9. Specialists in Boston could make no diagnosis for a year, and by the end of fifth grade, she had missed 45 days of school. The school principal was the first to mention CFS, knowing of another case, but Ms. McLaughlin remembered commenting that Amy was "not tired, only sick." By sixth grade, Amy was out of school, and even tutoring was hard. Amazingly, the school called the Department of Social Services and threatened to file for child abuse/neglect. The family hired a lawyer and agreed to take a full battery of psychological tests which showed no depression or family dysfunction. Ms. McLaughlin since has learned that this is not an abnormal story. She said that she and her husband were fortunate to be educated and politically connected; she shuddered to think what would happen to those less fortunate. She found it ironic that she is lauded for taking care of her 85 year-old aunt with early Alzheimer's, who is still functional, but people still think she is just defending her crazy child, who is not.
Ms. McLaughlin has investigated CFS treatments of all kinds, and was particularly interested in a patented CFS treatment called Peptide T. It was alleged to produce both functional and symptomatic improvement without changing the underlying viral infection. Dr. Klimas clarified that this patent was intended for HIV, but didn't work in that disease, so a second patent was sought to extend it to a different disease. Ms. McLaughlin stated that it is unconscionable that sick patients must search for information and find their own solutions, as well as educate many of those whose job it is to protect them. She stated that people are still suffering due to a lack of basic services and social support. They are ill, or are committing suicide, not from fatigue or deconditioning or depression or stress, but from negligence and apathy. She charged that their blood is on the government's hands.
Ms. McLaughlin's written testimony may be read online at: http://www.cfids-me.org/cfscc/mclaughlin0498.html
Ms. Vicki Walker, of the CFIDS Youth Alliance, thanked the committee and Dr. Satcher for their attention to CFS and CFIDS. She particularly appreciated the previous day's workshop, the first collection of diverse scientists to address the issues of children and adolescents with CFS. She lauded the significant advances made in that meeting, only one being that no one questioned the problem of children with CFIDS. Her goal is to ensure that the progress doesn't end; that meaningful actions ensue.
Therefore, she recommended that
Dr. Mary McKinney Schweitzer brought a list of comments from her organization, WECAN, Inc. [Ed. Note: Dr. Schweitzer resigned from WECAN in June 1998.] She reported the members' expressed rage when the name change was dismissed last Fall. The fact that the name remains in spite of being insulting is representative of their feeling of helplessness and voicelessness. The definition needs to be amended to ensure that companies cannot avoid disability payments. She urged the field to stop trying to identify CFS as a psychological disorder; the point of diminishing returns has been reached, and she bet that the really good research is not on psychosocial causation. She urged the brilliant researchers at this meeting to cite the good science, such as that done on brain scans, and to fault researchers who don't cite such good work. Standards are needed in this field. She asked that CDC begin to track CFS according to their own definition.
Dr. Schweitzer wished that any publicly-funded work, treatment or research, be required to screen for CFS and to track those patients. This would at least get people diagnosed. She asked that Medigap coverage be extended to the disabled and not just the elderly. She called for clinical diagnostic criteria for slow onset, and for types of illness: relapse/remission, recovery to 50% and stall, and permanent collapse and deterioration. She distributed a list on which 140 symptoms of CFS were listed, of which she has 91. All of these should be in the CDC and NIH brochures and physicians' bulletins. She cited consensus among CFIDS physicians around the country that noting the clusters of symptoms is the first step in diagnosing the illness.
She recalled Dr. Reeves' statement last October that at least 400,000 American adults have CFIDS. She pointed out that the CDC physician-diagnosed study cohort is 90% white female, but demographic studies indicate that CFS is an equal opportunity illness. Calculating backwards, that infers that over a quarter-million adult Americans (not even counting the children) have CFS and don't know what it is, because the government is waiting to tell the public about this disease until it has a definition. She stressed that enough is known to tell the public, and that a government agency is duty-bound to reveal its knowledge. She stated that whatever rationale is stopping this education is nothing compared to what it is like to have this disease. It is long past time for U.S. Government to do the right thing, she said; tell the American public what is known about this disease.
Dr. Schweitzer's written testimony may be read online at: http://www.cfids-me.org/marys/cfsccs98.html
Mr. Tom Hennessey of RESCIND (Repeal Existing Stereotypes about Chronic Immunological and Neurological Diseases) thanked Dr. Satcher for attending, and the CFSCC members. He applauded that, after seven years of his stating the similarity of GWS and CFS, the January JAMA had four 4 peer review articles on exactly that. The coincidence of CFS in macho military personnel should serve to support the reports of white middle class women often perceived as whiny. RESCIND is interested in MIE/CFS; MCS; FMS; and GWS. He stated that a high-level Pentagon representative should be present at the CFSCC meetings. Hillary Rodham Clinton pushed for discovery of what GWI was; Secretary Brown termed it as serious as a gunshot wound to the head. However, commensurately, he cited several articles dismissive of CFS.
At the first meeting about CFS in April 1989, Mr. Hennessey asked that the name be changed, as it demeans those suffering, does not differentiate this disease from any other, and makes no mention of the utterly disabling aspects. He quoted Pasteur: "The antigen is nothing, the terrain is everything." In his opinion, there is no one specific virus causing CFS; any virus or bacteria can trigger it in a genetically or psychologically predisposed individual. He noted recent data on infectious cardiomyopathy had not been mentioned at this meeting. He described himself as a Type A workaholic until he collapsed after eating raw oysters, and in the last six months, FDA cited a bacteria in Gulf of Mexico shellfish which can lead to symptoms similar to CFS. He disputed that the government is "getting the word out," quoting from the U.S. Office of Personnel Management that "... CFS is not generally considered to be disabling... progressive... or life threatening [but] self-limiting, and of a periodic or episodic nature. Symptoms are generally amenable to appropriate therapy... The diagnosis is one of exclusion because it can be caused by many other illness; [the condition] seems to be mostly an annoyance."
Ms. Pat Blankenship, from Georgia, has CFS. She read from a [1998] Readers' Digest article, "A Good Law Gone Bad," which lumped CFS with morning sickness, myopia, body odor, and infertility. Sadly, she said, that article will get more play than this meeting or anything else. The CFSCC needs to reply that this is not true. She also cited a 1995 Washington Post article saying that chronic fatigue is rare, according to an HMO study which cited CDC demographics. The Post's news is picked up by the wire services. Ms. Judith [Curren]'s suicide was assisted by Dr. Kevorkian, who also generates publicity. An AMA official was indirectly quoted as saying that since CFS normally doesn't affect the immune system, perhaps Ms. [Curren] was influenced by depression. Ms. Blankenship stated that if Ms. [Curren] wasn't influenced by depression, she was crazy. The August 1997 annual meeting of the American Psychological Association treated CFIDS as an affective disorder; one discussant was quoted as saying that "The burden of proof rests with those who think CFS is organic; there is nothing in the literature." Also in August 1997, the NY Times and the Wall Street Journal were dismissive of CFS's inclusion under the Americans With Disabilities Act. But the LA Times at least stated that CFS is not a benign debate; how it is viewed affects treatment. Ms. Blankenship stressed that a reaction team to such reports is needed, and suggested the CFSCC as the vehicle. There is a precedent to this in Dr. Philip Lee's response to negative press. The CFIDS Association has a public relations team, but a government response would carry more weight than a private organization. She suggested a canned press release into which the details could be inserted.
Ms. Blankenship's written testimony may be read online at: http://www.mindspring.com/~patpm/cfscc.html
Ms. Gail Dahlen, President of Medical Professionals/Persons with CFIDS (MPWC), reporting having communicated with over 1000 medical professionals. She cited eponyms chosen in the past, such as Mongolian Idiot Syndrome, now Down Syndrome; and Hysterical Paralysis Syndrome, now Multiple Sclerosis. All required a name change before society's acceptance, respect, and provision of research funding. She cringes at the name CFS, which requires explanation of more serious symptoms than the name implies. The name fosters shocking and vast discrimination. She stated that a specific cause is not needed to properly name it; everyone will be dead before the very thorough scientists find a specific cause. Multiple abnormal and multiple organ and systems data suggest testing for CFS patients, and numerous tests can show abnormalities in CFS patients. Nevertheless, the name persists, hampering funding to research. An Internet site today has over 1200 studies listed in bibliographic references. The AACFS site has over 2100 recent as well as historic references. She stated that the scientists' focus on psychological aspects of CFS have branded the patients.
Ms. Dahlen decried the fact that other countries' researchers are not included in American journals, and specifically lamented the abandoned transmission study of Dr. Thomas Glass due to lack of funding. She said that his reports were banned by research journals even though they praised the quality of his scientific methods. She also cited other CFS researchers who continue to try to help CFS patients even without federal support. She stated that the disease's name also affects moneys to clinics, citing a San Francisco clinic closed due to lack of funds.
Ms. Dahlen stated that all a name change requires is repeated use and education to the public and medical community. She urged that at least an eponym be added, such as was done with Lou Gehrig's disease. For example, advocates have supported the eponym of "Gilliam-Ramsay Disease" for years. She urged the government agencies and the CFSCC to end the misunderstanding of this terrible disease, and to remember the Hippocratic Oath, as this name harms all PWCs and their caretakers.
CLOSING COMMENTS
At this point, Dr. Mahy observed that the time was up for the meeting. Mr. Hennessy objected that people who had prepared extensively to give testimony were precluded by the adjournment hour. He suggested that at the next meeting the public testimony be scheduled earlier in the day.With the committee's agreement to meet again on October 13th in Boston, to take advantage of the MCFS national conference, the meeting adjourned at 5:09 P.M. with Dr. Mahy's thanks.
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