ATTACHMENT 7 UNITED STATES ATOMIC ENERGY COMMISSION WASHINGTON, D.C. 20545 707741 May 9, 1974 James L. Liverman, Director Division of Biomedical and Environmental Research PROGRAM REVIEW OF THE MEDICAL DIVISION OF OAK RIDGE ASSOCIATED UNIVERSITIES The following considerations have led to a proposal to change the structure of the program in the Medical Division of ORAU. 1. Oak Ridge does not have an appropriate demographic base with tertiary hospital facilities and a range of active programs in clinical investigation. The present clinical facilities of the Medical Division do not meet the standards necessary for accreditation. On the basis of program evaluation and institutional environment, it was recommended that clinical investigation should not be continued at ORAU Medical Division. 2. The nuclear medicine program and parts of the clinical oncology program could be incorporated into the East Tennessee Cancer Center at the University Memorial Hospital in Knoxville. This would strengthen the development of the Cancer Center and provide the necessary environment for Medical Division programs. 3. The immunology and biochemistry programs of the Division are geographically, operationally and intellectually isolated in the present ORAU structure. These programs would be more effective in association with the ORAU Biology Division. 1 4. The Medical Division of ORAU has been effective in conducting educational programs for physicians in management of radiation accidents and in assessment of radiation damage in man. These programs should be continued and perhaps associated with the capability to develop regional plans for the contingency of industrial exposure and accidental release of radioactivity. Exploration of the feasibility and implication of these propositions should be started in negotiations with representatives of the concerned institutions. Several issues should be addressed: 1. The cost of providing adequate space and facilities in the Cancer Center in Knoxville. 2. The attitudes of the staff at ORAU and Knoxville concerning the amalgamation. 3. The cost and extent of new facilities in the Oak Ridge Hospital that would serve as demonstration and instructional areas for radiation accident programs. 4. The impact of the proposed changes on other components of the ORAU program. 5. The need to satisfactorily relocate personnel in the ORAU Medical Division. 6. The ability of ORAU to mount a broad program in the sociology, epidemiology and contingency planning related to accidental exposure of human populations to radioactivity. Charles E. Carter, M.D. Manager, Biomedical Programs Division of Biomedical and Environmental Research ATOMIC ENERGY COMMISSION WASHINGTON, D.C. 20545 April 16, 1974 ORAU REVIEW For several years there has been growing concern over institutional and programmatic problems of the Medical Division of ORAU. The discussion of these problems which follows is based upon the comments of reviewers who visited the laboratory on March 4, 5 and 6, 1974. A. The Institutional Setting 1. The clinical facilities are substandard with respect to licensing and accreditation guidelines and replacement is sought by ORAU through new construction in a wing of the Oak Ridge Hospital. 2. The Medical Division conducts an investigative program in an area of relatively low population, in the absence of a tertiary hospital program adequate for the provision of specialized patient populations and services, and essentially isolated from the critical climate of academic clinical investigation. 3. The laboratories in the main building vary from adequate to marginal and are housed in a structure originally designed for other purposes and a short life time. The marmoset building contains good, permanent laboratories and the biochemistry building is considered to be sound and provides good laboratory facilities. The separation of these facilities makes effective interaction of professional personnel and the synergistic development of programs virtually impossible. 4. The animal facilities are separated in several buildings and except for the marmoset building all are considered to be strikingly inadequate with respect to construction, provision of animal care, quality control, separation of species, and sanitation. The animal care programs suffer from lack of professional supervision. 1 B. Programs The several programs in the Medical Division vary widely in quality. 1. Clinical Hematology. The reviewers gave this program an unfavorable rating. a. The METBI and LETBI programs were viewed as evolving without adequate planning, criticism or objectives, and have achieved less in substantial productivity than merits continued support. b. The marrow transplantation program came under severe criticism. In view or accepted therapeutic modalities, ethical questions were raised with respect to the protocols employed in these studies. The leadership of this program is not defined; the coordination with immunology is ineffective. The number of patients accessible to the study is small and argues against the continuation of transplant clinical investigation at ORAU. 2. Nuclear Medicine a. Radiopharmaceutical program. It was recognized that Dr. Hayes had demonstrated a high degree of capability and achievement. Questions were raised about the scope and directions of the 11C project, the absence of physical chemical data on Gallium complexes, and a discernible tendency for the program to drift without defined goals. The isotope production facility at ORNL is an asset to the program, but in order to be effective, a significant nuclear medicine clinical facility at a large teaching and research hospital is necessary. The program suffers by its present isolation. b. Clinical program. The number of nuclear medicine procedures performed is small and the interaction with Oak Ridge Hospital is minimal. The reviewers recognized Dr. Edwards' clinical competence and the dedication which he has brought to the program. There were questions about the design and evaluation of the Gallium cooperative study which limit the value of the collected data. The bone-scan investigation of Dr. Goswitz received unfavorable review comments. 3. Immunology. The reviewers gave this program top rating. Dr. Gengozian was recognized as a productive, innovative worker with well-defined research goals. It was recommended that increased support should be directed to this group. 2 4. Biochemistry. The projects under Dr. Snyder's direction were considered to be of high priority and productive of significant achievement. It was felt that he was intellectually, as well as geographically, isolated from the Medical Division. The reviewers raised the question of whether Dr. Snyder might not have more productive interactions in another laboratory setting. 5. Computer Services. This program is under the administrative control of Mr. Harmon, Dr. Andrews' administrative assistant, an arrangement which reviewers considered to be inappropriate for effective development of these facilities. In 1968 an IBM-1800 with peripherals was purchased. In 1972 a PDP-1L/20 was brought in, and since then there have been efforts to interface the computers. This system is not good computer science. An effort to use virtual memory concepts with the disc through the IBM-1800 and the change of the system from time sharing to multi-programming are laudable efforts, but not essential to any scientific program at ORAU. Interface attempts to the Ohio Nuclear Scanner and the gamma camera were questioned because the investigators lack sound notions as to what is to be done with the encoded data. Ideas of image enhancement and quantitation were not well thought through. Other critical comments of the reviewers related to the inappropriateness of a patient information data system for a small clinical service of eight patients per day, and to the random and unproductive interaction of the staff of the computer center with other investigators. It was observed that the use of computer service for the biostatistics associated with the Gallium study and other data analysis programs is appropriate, but could be implemented with or without the present computer hardware. 6. Experimental Pathology. Dr. Swartzendruber, an electron microscopist with considerable experience and achievement, received strong support from reviewers for his work on the biophysics and ultrastructural aspects of Gallium localization in tumors. There was less enthusiasm about his pursuing x-ray spectroscopy and transmission electron microscopy in anything other than collaborative efforts with available instruments at ORNL. 3 Dr. Nelson, a pathologist who does the routine work of the center, has recently received training in Germany. The reviewers were cautious in viewing his entry into a demanding and competitive program concerning the distribution and kinetics of labeled circulating stem cells. Although an enthusiastic and careful worker, it was felt that his lack of research experience, training, and scientific achievement might advise a collaborative effort or some opportunity for supervision. 7. Radiation Accidents: Human Radiation Exposure. The broad experience of Dr. Lushbaugh and his achievement in published assessment of human radiation exposure were considered by reviewers to have great value. Although a large part of his research effort is funded by NASA, it was considered to be effectively supportive of AEC missions and well done. It was reported by reviewers that the computer services have not provided adequate consultative treatment on statistical problems. Dr. Lushbaugh's new findings on colonic cancer in one strain of the marmoset were considered by reviewers to be a significant discovery worthy of substantial support. Drs. Andrews and Lushbaugh have been an effective team in dealing with problems of radiation accidents. 8. Microbiology. The comments of reviewers were generally unfavorable with respect to this program. The routine microbiology of the clinical services is handled by competent technicians and appeared to be of high quality. Dr. Tyndall was reported by reviewers to have little interest or background in clinical microbiology; as a result, some of the crucial studies of patients with total body irradiation have neither been followed up nor initiated. Dr. Tyndall's studies of Gallium were evaluated as being inadequately planned, isolated from consultation with immunologists and molecular biologists, and not coordinated with the principal responsibilities of the microbiology program. 9. Cytogenetics. Dr. Littlefield was appointed to work with Dr. Goh on a project supported by NIH dealing with cytogenetic effects of oral contraceptives in women. When Dr. Goh left ORAU, Dr. Littlefield became principal investigator and succeeded to responsibility in a study with many methodological problems. Dr. Littlefield was considered by the reviewers to be a technically competent cytogeneticist who had performed creditably, but who had not yet matured scientifically as an independent investigator. It was felt that the Medical Division had not developed a cytogenetics research program, and that much of Dr. Littlefield's effort was spent in unplanned and unused clinical supporting services. Dr. Littlefield has the potential to become a competent independent scientist. 4 10. Physics and Instrumentation. The work of Roger Cloutier and Evelyn Watson on problems of dosimetry was recognized as having outstanding merit. The cooperative work with Walter Snyder of ORNL suggested that a more suitable association for work on dosimetry might be at ORNL. The work by Gibbs on the whole-body counter is almost entirely in support of dosimetry studies. The work of Morris was viewed as instrumentation development proceeding independently of carefully assessed needs for problem solving. The projects were considered to be of low priority. C. Administration of the Medical Division In general, the reviewers were unanimous in their judgment that ORAU Medical Division was an institution with a creditable history, but one that is now faced with serious problems. While respectful of the administrative leadership of the division, it was recognized that the institution lacked the cohesion and scientific leadership to overcome the fragmentation of programs, variable scientific quality and inadequacy of clinical setting. These judgments, though strong in advocacy of change, were not made without recognition of the dedication and achievement of Dr. Andrews in a formidably difficult situation. Recommendations A. Clinical Research Programs The proposed construction of facilities in the Oak Ridge Hospital will not provide the clinical setting necessary for the development and sustenance of a clinical research program in nuclear medicine, radiotherapy and clinical oncology. There are several options to be considered. 1. Phase out programs in clinical research. 2. Disperse those clinical programs with good competitive standing to regional University Medical Centers for independent funding. 3. Transfer programs in nuclear medicine and oncology to the East Tennessee Cancer Center at the University of Tennessee Memorial Hospital in Knoxville. 4. Concentrate on a nuclear medicine program at Oak Ridge which places little emphasis on clinical research and heavy emphasis on basic mechanisms, isotope production and instrumentation development in association with Oak Ridge National Laboratory. 5 These options were proposed and discussed in some detail by our reviewers. The concensus supported the consolidation of clinical research and supporting programs, such as experimental pathology, with the University Hospital and Cancer Center in Knoxville. Such a development would considerably strengthen both institutions. At this time, all of the factors which will influence decisions in the several institutions involved are not known; and we view this recommendation as an opening move in a series of negotiations, many of which depend on the status of the Cancer Center program at Knoxville. B. Radiation Accidents and the Social Strategy for Dealing with Human Exposure to Environmental Radiation 1. The extensive experience of Drs. Lushbaugh and Andrews in problems of radiation accidents argues for supporting a facility in Oak Ridge which would consist of a demonstration unit in the Oak Ridge Hospital with laminar flow rooms and a decontamination area suitable for treatment of accident subjects. This facility would serve as a focus for a teaching program addressed toward physicians and public health officials who are charged with responsibility in environmental health planning. 2. The above program should be coordinated with a sociological research and assessment program at the ORAU campus which would address problems of preventive and response planning for environmental contamination resulting from accidents and nuclear fuel release. This program might develop with well-defined relationships to the "think tank" for energy options which ORAU has initiated. 3. It might also be appropriate at this time to think about centralizing the information processing and some components of the human epidemiology programs relating to occupational exposure and health assessment of workers at a facility such as that proposed for ORAU. The computer center now serving the Medical Division might then be transferred and restructured to serve this function. C. The Immunology Program and the Biochemistry Program should be brought into administrative association with ORNL and as soon as feasible into that laboratory. The strength of these programs and the adequacy of present facilities is recognized, and alternative options might be considered. 6 D. The Medical Physics and Instrumentation Program would be more appropriately developed in ORNL. The recognized merit of Dr. Cloutier's work in dosimetry would undoubtedly lead to the possibility of incorporating his program into a combined effort at the Cancer Center, University of Tennessee Hospital in Knoxville, should this proposition be developed. E. In recognizing the potential of Dr. Littlefield to develop as an independent investigator in cytogenetics, a transfer of her program to the cytogenetics group at ORNL is recommended. F. The Microbiology Program might be identified with several institutions; at this time no recommendation is made. In making these recommendations, there is recognition of the dislocation and discomfort they entail. There is a determination, however, to deal sensitively and considerately with the people involved. At the outset it should be realized that we are embarking on a series of meetings with several concerned parties; we propose several recommendations to orient the discussions. With considerable firmness we respond to the recommendation of our reviewers and our staff that the present configuration of the Medical Division of ORAU must change. As a consequence of these recommendations, certain actions with respect to construction of facilities are entailed. 1. ORAU and AEC should not enter into an agreement with Oak Ridge Hospital for the construction of a 26-30 bed clinical facility. 2. The possibility of a demonstration accident treatment facility with an attached decontamination unit as part of the new construction being planned at Oak Ridge Hospital should be explored. This facility might contain two laminar flow rooms, offices and a conference area. 3. There should be no new construction of animal facilities. The changes resulting from these recommendations should take place over a period of two to three years. 7