Data obtained from the Surveillance Networking study suggests that the program should be expanded to include children in the age group 8 to 18. Presently, only patients over 18 years of age are studied. Researchers feel it is difficult to use depression as a symptom and as an evaluating factor when dealing with children; additional data and information are needed to evaluate children. Funds should be made available for addition of this youth study for the remainder of the program. Outbreaks of CFS continue to develop across the nation. The CDC indicates that there may be two types: endogensis CFS and epidemic CFS. The CDC should expand its Surveillance Program to be able to react quickly to such outbreaks with a team ready to get to the sites promptly. Some CFS research is being undertaken on retro-viruses. The CDC should have additional FTEs for research in the retro-virus area. This lab work is very labor intensive and should be undertaken by full time workers. Funds should be allocated for state-of-the-art equipment to speed up laboratory studies. Some of the Surveillance Networking data leads the CDC to believe that there may be new directions in determining points of common exposure which lead to CFS. Researchers are looking for an agent which causes the disease and they may find it through a common exposure. The CDC should do an Exposure History on patients who have the disease. This work can be accomplished by a contractor working under the direction of CDC. Added funding for case control studies relating to data which is being developed in the Surveillance Networking should be made available. Surveillance experiences, data and techniques could be used to determine national prevalence of CFS by combining with a national digit dialing telephone survey. The CDC is doing an ever improving job of informing the public. There is an increasing demand for information from physicians and patients. To relieve the CFS researchers who are now handling many of these inquiries by phone and patient visits, it would be more productive to use a contractor working under the direction of the CDC to send out information and talk to those who call or visit. Such support by an outside contractor would free the CDC staff to concentrate on research. Funds should be allocated for public and physician information. We are pleased to see that taped information about CFS has been made available to touch tone telephone users by the CDC. The CDC is finding that there are many health professionals with CFS and should be encouraged to study the degree to which health professionals are affected. This work could be done by a contractor who could determine the impact of this disease. Studies should be undertaken to learn more about the function of hormones in CFS remission. Researchers indicate that up to 75% of CFS cases they are studying are females. One researcher has found that there is some remission of CFS related to pregnancy and post delivery. Hormone studies could give direction for research which may provide important answers to the CFS problem. SOCIAL SECURITY ADMINISTRATION From information we have received from patients and physicians around the country, the Social Security Administration appears not to have followed the directions of this Committee in Report 101-516 which stated: "...The Social Security Administration is directed to: (1) update its guidelines on CFS by including a wide range of current medical information on this illness such as the research definition developed by the Centers for Disease Control, (2) increase awareness of this illness by all staff involved in disability claims processing. The primary symptom of CFS is à debilitating fatigue which does not lend itself to objective measurements. Consequently, the severity of CFS should be determined by the symptoms and functional limitations. Many Social Security judges do not believe in the existence of CFS because they have not been educated about this illness, nor have they been properly informed by the SSA. An attorney who handles SSA cases for many CFS patients advised that before a patient gets to the judge level, the vast majority are denied benefits. These patients are forced to go to an appeal and then appear before a SSA judge -- procedures which are made even more difficult because of the debilitating fatigue suffered by those with Chronic Fatigue Syndrome. Proper action by SSA in recognition of CFS will stimulate similar clarifications on the part of third party insurers and ease the current confusion regarding insurance coverage for CFS patients. This Committee should direct the Social Security Administration to develop a consistent national policy regarding CFS and publish a mandatory ruling which will: a) Recognize the legitimacy of Chronic Fatigue Syndrome by name. b) Recognize the legitimacy of CFS as a physical illness. PUBLIC INFORMATION Because it affects so many people, CFS continues to be the subject of stories and reviews in many popular publications. A two page story appeared recently in People Magazine. In November 1990 there was a lengthy cover story about this illness in Newsweek. New books are being published; there are many articles appearing in newspapers; there are mentions on radio and on TV news broadcasts; and there are segments or full radio and TV programs devoted to coverage of CFS. CFS has obtained a key word listing in the NIH Key Word Thesaurus. The 1991 Edition of the NIH Information Index includes "Chronic Fatigue Syndrome" as an indexed topic. The NIH and CDC have issued information bulletins on CFS. COORDINATE RESEARCH The constraints of the Budget make if difficult to achieve all of the objectives of those who are studying CFS. The NIH and CDC can take the initiative and leadership to consolidate and coordinate CFS research activity and: 1) Recommend standardized instruments for collection of clinical data. 2) Systemize the evaluation of functional health status according to standardized 3) Advise regarding the establishment of a standardized protocol for laboratory tests. 4) Provide for storage of both sera and leucocytes for future testing. This may be one of the functions of a Center. On the environmental side, some research study should be conducted regarding toxic exposure and how it might relate to CFS. It is not the purpose of my testimony to this Committee to recommend any one research direction. It is apparent from the many communications that we receive from patients and researchers, from reports about CFS in medical journals and in support group newsletters, that more research is needed. During the next fiscal year, this Committee should hold hearings to study how the allocated funds to the NIH and the CDC are actually being used for research and support of Chronic Fatigue Syndrome studies. The Commissioner of the Social Security Administration (SSA) should again be directed to provide a Report to the committee during the first quarter of the fiscal year on SSA activities related to CFS. WE URGE THIS COMMITTEE TO DIRECT OR RECOMMEND: The National Institute of Allergy & Infectious Diseases (NIAID): 1) Expand internal research studies on Chronic Fatigue Syndrome (CFS). 2) Increase funding for extra-mural research on CFS. Issue more RFAs in etiology, pathophysiology, medical treatment, and interplay with allergy and neurological involvement. 3) Establish more Multi-Centers for study and care of CFS patients. Provide for the storage of sera and leucocytes for future testing. 4) Make funds available for Small Grants on CFS research. ($500,000) 5) Continue the program of workshops and meetings for dissemination of information about CFS to health professionals and to the patient community. 6) Study the advisability of conducting research or data accumulation of continued immune dysfunction on CFS patients who are presumed to be in remission. 7) Start a CFS patient registry. Study establishment of a Central Clearinghouse for CFS data 8) Expand NIAID cooperation in basic CFS research with: National Cancer Institute, National Institute of Mental Health The Centers for Disease Control: 1) Expand CFS Surveillance Network Program (added sites) and epidemiology activities. Additional funding of $750,000 should be provided to: a) conduct case control studies in surveillance areas b) include children aged 8 to 18 in Surveillance Program c) provide for a prompt reaction to CFS outbreaks with a team ready to get to sites d) conduct Exposure History on patients who have CFS. 2 Expand immunologic studies, virologic studies, toxic studies and conduct long term 3) Add FTEs in the retro-virus study area. Full time workers should staff this critical 4) Continue CFS public and health professional information, and education. Relieve 5 Study the degree to which health professionals are affected by CFS. ($250,000) 6) Study the function of hormones in CFS remission. 7) Determine the national prevalence of CFS using data from the Surveillance Networking; and a national random digit dialing phone survey. Social Security Administration: 1) Publish a mandatory rule recognizing the legitimacy of Chronic Fatigue Syndrome by 2) Issue directions or regulations regarding treatment of the claims of CFS patients. On behalf of the dedicated CFS researchers, patients and their supporting families, we thank this Committee for its attention to this continuing national health problem. We ask that the Committee continue its efforts in support of CFS studies so that research will lead to answers about this debilitating syndrome which affects the lives of so many. STATEMENT OF DR. RONALD D. HUNT, DIRECTOR, NEW Mr. Chairman and Members of the Committee: I am Dr. Ronald D. Hunt, Professor of Comparative Pathology at the Harvard Medical School and Director of the New England Regional Primate Research Center. The seven Regional Primate Research Centers were established by Congress in the early 1960's. Each is hosted by a major university, and recieves base support (core support) from the Comparative Medicine Program of the National Centers for Research Resources, National Institutes of Health. The Regional Primate Centers Program is unique and irreplaceable. They serve as (1) research resources (2) centers of primatology and animal models development and (3) biomedical research centers. (1) As resources the Centers serve our Nation's biomedical research program at large allowing affiliated scientists from other institutions to conduct important biomedical research which otherwise could not be pursued. There has been a growing reliance upon the Primate Research Centers for the conduct of research dependent upon nonhuman primates. Between 1986 and 1989 there was a 45% increase in utilization with over 797 scientists utilizing Center resources last year to conduct their research, the vast majority of which was funded by the N.I.H. The research of these investigators from Universities and laboratories across the country is addressing such diseases as diabetes, blindness, multiple sclerosis, cancer, hypertension, and many others. The importance of the Centers as resources will continue to increase as the guidelines and standards necessary for maintaining nonhuman primates become more stringent and as nonhuman primates become unavailable from their native countries. Last year only 2,300 primates were imported into the United States. In the 1980's the annual figure ran around 20,000 and when primates were required for the development of the polio vaccine, the number of imported primates exceeded 100,000 per year. (2) As Centers of Primatology and Animal Models Development the Primate Centers are truly a unique biomedical resource. Through research to better understand nonhuman primates their availability for future research can be ensured. Research designed to clarify their nutritional requirements, reproductive biology, behavioral needs and diseases is absolutely necessary for successful breeding programs, the production of healthy animals and their most efficient utilization in research. This is a charge of the National Center for Research Resources and the Primate Centers Program. It cannot be funded through other mechanisms. There is another benefit from this research effort in primatology. That is the identification of important animal models for human disease. The Primate Centers have uncovered and developed important models for many human illnesses, such as ulcerative colitis and cancer of the colon, leprosy, herpesvirus infections, Parkinson's disease, and most importantly we have developed an animal model for AIDS. Through the careful study of naturally occurring diseases of monkeys the Primate Centers identified a virus now called SIV which is very similar to HIV the cause of AIDS in human beings. SIV causes an AIDS-like disease in monkeys which has been recognized as the most important animal model for the human disease. This is the most important model developed in the last decade; if the Primate Centers had not done anything else, this contribution would more than justify their existence. I think most everyone would agree that the discovery of this model would not have happened if the Primate Research Centers Program had not existed. (3) As research centers the Primate Center's Faculties or core staff are making major contributions of national and international importance. Research on AIDS utilizing the SIV model system, which they developed, dominates the current research effort. Major progress has been made in understanding the pathogenesis of AIDS, how the virus causes its devastating effects on the immune system, new therapies and the development of strategies for effective vaccination. AIDS is however not the only disease of importance being studied by Primate Research Center investigators. Important programs in cardiovascular disease (our Nation's number one killer), drug addiction (a National emergency), cancer, malaria, leprosy, organ transplantation, Parkinson's disease, in vitro fertilization, fetal development, environmental induced respiratory disease, hemorrhagic shock, cataracts and many others. Basic biomedical research at the centers is predominantly supported by individual grants to the core staff or affiliated scientists using the Centers as resources. The NCRR support to the Centers is however absolutely necessary to provide the appropriate infrastructure for this research to proceed. Research in primatology, models of human disease development, primate breeding colonies and the appropriate support for a scientific staff are entirely dependent upon NCRR funding. Support for the Primate Research Centers Program has declined in absolute dollars for the past several years. The budget for the Regional Primate Research Centers Program as declined in absolute dollars for the past four years. When you take into account inflation and in particular the extraordinarily high rising costs of biomedical research, the budget for the seven Centers has seriously declined. Since 1980, the real purchasing power of the Centers' Base Grant has decreased by about 44%. This has led to erosion of the Primate Centers ability to adequately pursue their mission. Those individuals so essential to providing veterinary care and the study of the basic biology of primates and thus in a position to develop important new models have either been eliminated or shifted to independently funded biomedical research programs, effectively eliminating them from the Center staff. Thus those individuals and programs that led to such major contributions as the discovery of SIV as the best model for AIDS have been eroded. The opportunity to uncover yet additional important models will not be developed without adequate support, a most somber thought for health research. Based upon the peer review system, the Regional Primate Centers have an approved N.I.H. budget of $39,374,681 almost $14,000,000 more than they are awarded. I urge Congress to carefully examine the inadequacy of their present budget and to make every effort to increase the appropriation by 10 million dollars to a total level of $35,000,000. This move will compensate for the erosion that has taken place for the past decade. |