Attachment 2 THE RADIOISOTOPE PROGRAM DEPARTMENT OF MEDICINE AND SURGERY U. S. VETERANS ADMINISTRATION 15 SEPTEMBER 1947 --- 15 SEPTEMBER 1948 CENTRAL ADVISORY COMMITTEE ON RADIOISOTOPES SUMMARY AND SPECIFIC RECOMMENDATIONS The Central Advisory Committee on Radioisotopes desires to present to the Chief Medical Director and to Director of the Research and Education Service certain viewpoints which may have a bearing on policy determination and to make certain specific recommendations in relation thereto. A detailed discussion of the problems involved is included in the minutes of the meeting of the committee which was held on September 15, 1948, in Washington, D.C. It is the unanimous opinion of the committee that an exceptionally good job has been done during the first year in getting the Radioisotope Program of the Veterans Administration underway and that the progress in organizing, outfitting and staffing the various radioisotope teams has been truly remarkable. This could not have been done without the cooperation of the Deans Committee and the active support of the medical staffs of the associated medical schools. 1 15 September 1948 1. The hospital of the future which intends to provide first rate medical care will make provision for the use of radioisotopes in both diagnostic and therapeutic applications. To do this properly a specialized activity within the hospital will be required together with suitable professional staff and laboratory facilities. It appears quite likely that such activities will be organized along lines somewhat similar to those currently employed in the establishment and operation of the Radioisotope Units of the Veterans Administration. It further appears (a) that the activities of such a unit will provide a specialized professional service which will in general follow somewhat the traditional pattern of the radiological service of a hospital and (b) that it will parallel rather than supplement such a radiological service. It is recommended therefore (a) that, in matters of policy, these considerations be recognized and (b) that in planning for construction of new hospitals of the Veterans Administration that approximately 2000 square feet be allocated as space for a laboratory for this purpose. It is further recommended (a) that the floor plans which have been prepared for Central Office Construction Service by the Radioisotope Section be employed as a general guide in planning for such facilities, and (b) that such space be placed in as close proximity to the General Medical Research Laboratory as may be practicable. - 2 - 2. During the first year of operation of the radioisotope program of the Veterans Administration, remarkable progress has been made. The outlook for even more successful accomplishment during the second year seems assured. It is recommended, therefore, that the program be developed in such a manner during the second year as to carry on the work initiated during the first year and that this be extended in the development of the new units at Fort Howard and San Francisco and if possible at Denver. 3. The problems of administration within the hospital, which have a bearing on the radioisotope program within that hospital, require coordination between the Chiefs of various services. It is recommended, therefore, (a) that at each hospital where there is a Radioisotope Unit there be set up by the manager a committee to be known as the Hospital Radioisotope Committee and (b) that it be responsible for effecting within the hospital the coordination required between the representatives of the Radioisotope Unit and the staff of the hospital in such matters of a professional service or administrative nature as may be required. It is recommended that the Hospital Radioisotope Committee parallel the Radioisotope Committee representing the Deans Committee, and that from time to time it meet the latter - 3 - committee in order to effect such coordination as may be required in the effective conduct of the radioisotope program within the hospital. It is recommended that the Hospital Radioisotope Committee be composed of the Clinical Director, who will serve as Chairman, the Chief of Medical Service, the Chief of Surgical Service, the Chief of Radiology and the Chief of Clinical Laboratory and Pathology and that the Director of the Radioisotope Unit serve as Secretary. 4. There are many reasons why the Director of a Radioisotope Unit should be a physician on a full time basis. It is recommended (a) that as soon as practicable all Directors of Radioisotope Units be physicians on a full time basis and (b) that physicians serving in this capacity on a part time basis and individuals other than physicians serving in this capacity be designated as Acting Directors of Radioisotope Units. 5. No hospitals within the Veterans Administration should be officially designated as special radioisotope treatment centers. There is as yet no sufficient evidence to indicate the superiority of radioisotope therapy over other forms of treatment. The Committee feels on the other hand, however, that in individual cases it may be desirable to have a particular patient transferred to a hospital where there is a Radioisotope Unit for this purpose. For such patients it is a problem to be worked out at the local level through the managers concerned and the Branch Medical Director and requires - 4 - no Central Office policy. It is not deemed wise to issue blanket statements to the effect that within certain geographic areas where there are units that all cases of leukemia should be sent to that hospital whether for research or therapeutic purposes. This statement is not intended to restrict the transfer of such patients as may be deemed desirable at the local level whether for research, diagnostic or therapeutic purposes. It is recommended that no Veterans Administration hospitals be officially designated as Radioisotope Treatment Center at this time. 6. There are many reasons why patients requiring special metabolic studies or radioisotope studies may need to be segregated. The greatest justification arises from the need for particular care in making certain clinical observations and the need for care in the collection of specimens. Segregation is not needed for reasons of safety to personnel as far as radioactivity is concerned. Nurses and attendants so employed must be trained in their particular duties. Conservation of the services of trained personnel may be better effected when such studies can be carried out in a ward specially set up for this purpose. Concentration of patients in this manner also facilities utilization of specialist medical personnel and special purpose equipment. Such a ward should serve a dual function (a) for metabolic studies and (b) for radioisotope studies. Such a ward - 5 - should be a "Metabolism Ward" and not a "Radioisotope Ward", or a "Research Ward". The beds and personnel for such a ward should be considered a part of the normal activities of the hospital set up to provide a professional service within the hospital. Funds and personnel ceiling should come from normal hospital allowance and not from research funds. It is recommended, therefore, that within those hospitals where there are Radioisotope Units, and where special need for the provision of segregated beds for radioisotope tracer studies can be shown shown to exist (a) that there be set aside beds and staff for this purpose; (b) that they be provided from normal hospital facilities or professional staff rather than from "research", (c) that such wards be designated as "Metabolism Wards" for the purpose of metabolic and/or radioisotope tracer studies; and (d) that all Branch Medical Directors and Hospital Managers as are involved be advised by Central Office that this is the policy to be followed in the administrative and fiscal aspects of this matter. 7. Cobalt 60 may be considered as a potential competitor of radium in its therapeutic application (external irradiation in the conventional sense). The exact position of Cobalt 60 as a substitute therapeutic agent is not established. Its most applicable form will probably be as needles, placques or discs, et cetera. - 7 - Work is now under way in the Atomic Energy Commission projects in this respect. Although it is a radioisotope it does not come within the family of radioisotope suited to the needs of either tracer methodology, diagnostic use or internal therapeutic application (intravenous or parenteral). There is not strong justification for its use in Veterans Administration hospitals at this time. It must be used with caution and only by fully qualified radiologists. It is recommended, therefore, (a) that Cobalt 60 be excluded from the activities of Radioisotope Units of the Veterans Administration, and (b) that such use of Cobalt 60 as may be made within the Veterans Administration hospitals be under the cognizance of the Chief, Radiological Service, Central Office and in accordance with such directions as he may provide. 8. The relationship of the radioisotope program to the General Medical Research program should be as close as possible although actual occupation of the same laboratory space and frequently the common use of certain laboratory supplies, may be inadvisable. It is recommended that the interests and activities of such Radioisotope Unit be associated with those of the General Medical Research Laboratory as closely as possible, consistent with the objectives of the two programs. 9. The Committee recognizes the difficulties with respect to the employment of scientists and technicians who are qualified in radioisotope work and who are not physicians. - 7 - It is recommended (a) that the Office of Chief Medical Director support in every manner possible the solution of this problem and (b) that some consideration be given to the possibility of proposing legislation which would permit the employment, by the Veterans Administration, of scientific and technical personnel as "Medical Allied Scientists" in a manner similar to the employment of physicians in the Department of Medicine and Surgery personnel under Public Law 293. 10. Publicity with relation to the Veterans Administration radioisotope program presents many problems for consideration, not the least important of which is informing personnel within the Veterans Administration. This should precede a general program of information to the public, and should be initiated as soon as practicable by such media as are available within the Veterans Administration. It is recommended (a) that the personnel of the Veterans Administration be informed of the radioisotope program of the Veterans Administration as soon as practicable, and (b) that such information should highlight the likelihood of new and improved diagnostic techniques and the benefits to be derived from research rather than highlight the value of its therapeutic use. 11. The study of the biologic effects of external radiation does not come within the scope of the radioisotope program of the Veterans - 8 - Administration. It is undesirable to include such studies because of the need for qualified staff, specialized facilities and a great number of experimental animals. It is recommended that Radioisotope Units of the Veterans Administration do not engage in studies of the biological effects of external body radiation. 12. In the near future guidelines as to "maximal permissible dosages" for the various radioisotope which may be employed in Veterans Administration hospitals should be tentatively established and promulgated to the various units. This will require the assistance of the medical radiologists on the committee and also that of appropriate representatives of the Division of Medicine and Biology of the Atomic Energy Commission. The need for this is recognized. It is recommended (a) that as soon as possible there be assembled serviceable guidelines as to "maximal permissible dosages" of the radioisotopes which may be employed in tracer studies and (b) that they be sent to the Directors of the various Radioisotope Units for their guidance. It is further recommended that these be prepared, and similarly promulgated, guidelines (a) as to diagnostic dosages which are permissible in the normal and in hopelessly afflicted individuals and (b) as to therapeutic dosages deemed suitable and the conditions in which they apply. - 9 - MINUTES OF THE MEETING CENTRAL ADVISORY COMMITTEE ON RADIOISOTOPES U. S. VETERANS ADMINISTRATION September 15, 948 Washington, D. C. 10:00 A. M. I. INTRODUCTION Dr. Freer expressed regret that Dr. Magnuson who is keenly interested in the Radioisotope Program could not be present. On his return he will be brought up to date on the deliberations of the meeting of the Central Advisory Committee on Radioisotopes. II. REPORTS OF PROGRESS Dr. Lyon reviewed briefly the progress of the program during its first year and presented highlights of summaries included in prepared statements (Enclosure A, B). He then discussed in general terms some of the problems of construction and alteration and the difficulties of employing scientific and technical personnel required under Civil Service. Dr. Lyon stated that approximately 100 doctors of the Veterans Administration had attended various courses of conference on the use of radioisotopes or related subjects given at a variety of different laboratories or centers. The Administrator has been active in supporting attendance of VA personnel at such courses or conferences. Approximately 20 VA doctors attended the recent three weeks course in tracer methodology at the University of California, Los Angeles. Dr. Lyon then reviewed the highlights of the progress summaries submitted b the individual units for the year ending September 15, 1948 (Enclosure C). - 2 - The Regional Consultants reported briefly on the units in their respective areas. Dr. Shields Warren: The situation at Framingham is quite good. Dr. Ross has had long experience in this field. Due to the interest of Dr. Ross and the Radioisotope Committee, through the cooperation of the hospital manager and his staff, good progress has been made. There is great interest in this field in the universities within the Boston area. This unit can be counted on as being one of the best of the units. Dr. Ross has succeeded in interesting the neurosurgeons in the use of radioisotopes. The safety program has been very satisfactorily worked out. The radioactive material is being properly handled. The staffs of the three medical schools have shown great interest in the unit and have supported it. The medical staff of the hospital is showing keen interest in the program. Dr. Shields Warren: The Bronx Unit is fortunate in having the assistance of Doctors Failla and Quimby. The individual who is actually responsible for the handling of the radioisotopes is a student trained by them and thoroughly competent. The Bronx Unit at present is emphasizing diagnosis and therapy rather than research. It might be well to pay a bit more attention to research. Because of the proximity to Brookhaven National Laboratory, the Bronx Unit could to advantage consider the use in research in connection with short "half-life" radioisotopes from that course. It is hoped that this can be worked out. - 3 - Dr. Shields Warren: The planning for the new unit at Fort Howard is going ahead satisfactorily under the direction of Dr. John Bowers. Dr. Perrin Long: The manager at Fort Howard is always very cooperative with the Deans Committee. Dr. John Bowers will head up the unit. Dr. Bronk is very anxious to have him retain his connection with the Atomic Energy Commission. Beginning this next month Dr. Bowers will get the planning of the staff and facilities underway. He will also have an appointment in the Department of Preventive Medicine, John Hopkins Medical School. Dr. (Illegible) is building a very sensitive mass spectrometer at the University. Dr. Hymer Friedell: There have been serious administrative delays at Cleveland. This difficulty has not been limited to the radioisotope program. It has been much more inclusive. Within the past month the problems of construction and alteration for the Radioisotope Unit appear to have been corrected and the situation should clear up in the near future. Much of this has been due to lack of personal contacts. Because of delay in the construction of the laboratory it has been difficult to maintain interest of personnel associated with the unit. Meanwhile, some of those actively engaged in the program of the unit have been able to work in the laboratories of the University. Progress has been made in orientating personnel and in developing technique through the use of the university laboratories. We have been studying the normal distribution of I-131. Formerly we - 4 - were confining the therapeutic use of I-131 to individuals over 40 years of age. Younger individuals are now being treated as well, since our experience and that of people all over the country indicates that radioactive iodine is an extremely satisfactory method of treating uncomplicated hyperthyroidism. The results are promising in hyperthyroidism. P-32 has given good results in leukemia. Dr. Holden has become quite interested in the use of radioisotopes in the peripheral vascular diseases, and in working on this problem in the university. A physicist and assistant physicist have been employed for this unit. A physicist from the university serves as consultant. Dr. Harden Wood, one of the consultants has worked with C-14. We will not use this radioisotope until the laboratory facilities are adequate for such work. Iodine is useful in tagging proteins before they break down. Iodine protein combinations have been used in blood volume studies. The amount of I-131 used is 20 microcuries. A greater personal contact with every one involved is needed and an attempt to correct this will be made. Dr. Hymer Friedell: At Hines the progress is very satisfactory. Dr. Tweedy formerly of Loyola Medical School has been added to the staff of the Radioisotope Unit at Hines, on a full time basis. Dr. Shields Warren: Northwestern University will have an intergraduate medical school in which will be set up with the aid of Atomic Energy Commission funds, a central radioisotope handling and preparation facility. This should be most helpful to our unit at Hines. -5- Dr. Hymer Friedell: With regard to Minneapolis we are very fortunate in having Dr. Armstrong so actively interested in the Radioisotope Unit. There is very close liaison between the university and the hospital including the unit. The project for the alterations of the unit were submitted to Central Office last May. It has within the past two weeks been signed by the Administrator. This delay imposed a very serious handicap on the unit. It should move ahead nicely now. Dr. Hymer Friedell: With regard to the unit at Dallas, it is desirable to recognize geographic distribution insofar as possible. There are, however, some local problems which Dr. Lyon should look into personally as soon as he can. Dr. Lyon: If these difficulties can not be righted it may be necessary to recommend the removal of the unit to another hospital. The difficulties center around two facts (a) The absence of an active radioisotope program of sufficient scope in either of the local medical schools and (b) the geographic isolation with respect to other centers where such work is being done. In attempts to employ personnel for the unit both of these have had an important bearing on the reluctance of individuals to accept. Dr. Shields Warren: The Atomic Energy Commission has established a training institution in connection with the medical schools in Houston, Texas; Durham, North Carolina; Denver, Colorado and Portland, Oregon. Dr. Furth, the Pathologist at Branch Clinical Laboratory, -6- Dallas, says that the Radioisotope Unit group there is not letting anyone who is not actively engaged in the work of the unit in on any of their work, and that they even keep the doors to the unit locked when they are not there. The fact that they are so secretive about the unit is detrimental to the welfare of the overall radioisotope program there. It should not be so compartmented. The possibility of a unit in connection with Rice or Baylor may be considered if not practicable at Dallas. Dr. Lyon: The program at Van Nuys, California has progressed beyond that in any other hospital. here Dr. Morton and the Doctors Fink are doing exceptionally fine work. The latter are employed in the General Medical Research program but they "team up" in a most desirable manner with Dr. Morton. The cooperation of the manager, hospital staff and university representatives has been outstanding. Dr. Lyon: The problems at Los Angeles are now being ironed out. They have been almost entirely administrative. Dr. Libby who has "tagged" and studied bacteria and viruses has been employed as a consultant. He is the Chief planner now. He is spending a great deal of time in getting the unit set up and under way. He and Dr. Roger Egeberg are working together on this. They will have a fine tie in with General Medical Research under Dr. Basett. Dr. Lyon: With regard to the new unit at San Francisco, the outlook is first rate. The interest of the Deans Committee is keen. Dr. Newell, Chief of Radiology at Leland Stanford was appointed -7- Chairman of the Radioisotope Committee in late August. he began to work on this matter at once. At the same time he is setting up a similar laboratory of his own at Stanford. Doctor Robert Stone and his staff are actively interested. This will be a fine unit. Both Branch Medical Director and Manager are keenly interested and most cooperative. Dr. Lyon: The assistance and cooperation of the following Branch Medical Directors has been most commendable. Dr. Carroll, Branch No. 1 Dr. Butler, Branch No. 2 Dr. Goode, Branch No. 7 Dr. Anderson, Branch No. 8 Dr. Cady, Branch No. 10 Dr. Bell, Branch No. 12 The assistance and cooperation of Dr. Volpe, Branch Medical Director in Branch No. 6, was equally commendable when appropriate contact between the station and Branch Office was affected. The difficulty here appears to have been at the station level. The assistance and cooperation of Dr. McCallum of Branch No. 4, is assured by the personal interest he has already shown. He is delighted that Fort Howard has been selected as a hospital to have a Radioisotope Unit. 8 Dr. Lyon: The active support of all managers in hospitals where unit have been established has been most commendable. There have been unfortunate delays at Cleveland and Los Angeles. Now that the situation has been clarified in both instances, suitable cooperation in the future can be expected. It is only fair to state that much of the difficulty which has been encountered arose (a) from awkwardness on the part of the Chief, Radioisotope Section and (b) because during most of the year there was not sufficient personnel within the Section to properly contact the individuals concerned at all levels. Recess for lunch - 9 - 2:00 P. M. III. PRESS CONFERENCE A press conference was held at 2:00 p.m. with all members of the Central Advisory Committee on Radioisotope, Dr. Freer, and members of the Radioisotope Section present. Subject "VA Radioisotope Program". The Committee members made complimentary statements to the press with respect to the accomplishments of the VA Radioisotope Program in the post-war era, and its importance in American medicine. Members of the Committee discussed various applications of radioisotopes in medical research, diagnosis and therapy. This conference formed the basis of a "pubinfo" release of a general nature (Enclosure A) and for some radio broadcasts which were carried on national networks, (Enclosure F). There were many complimentary remarks regarding the excellent presentations of the committee members to the press at this time. 2:45 P. M. IV. DISCUSSION OF CLINICAL APPLICATIONS P-32 There was a general discussion of the use of P-32 in polycythemia rubra vera. Dr Shields Warren was quite optimistic over the results. He felt this form of treatment was better than venesection and the use of chemicals to depress erythropoesis. Dr. Morgan felt that venesection was quite satisfactory and had the advantage of being simple. - 10 - There was a general discussion of the use of P-32 in thronic leukemia. Dr Friedell stated that P-32 had given very good results. Dr. Shields Warren agreed and stated that it was an additional form of therapy of value, and that by employing a variety of different forms of treatment that it was possible to prolong considerably the period of useful activity and comfort of the patient with chronic leukemia. He cautioned that the problem of toxicity of P-32 was still one to give concern. Dr. Friedell suggested that P-32 in colloidal from in leukemia may be more satisfactory than the equaous solution now employed. Dr. Shields Warren stated that P-32 was to be employed in tagging red blood cells for blood volume studies at Framingham. Dr. Stafford Warren cautioned against too much enthusiasm in the use of P-32 locally in the treatment of basal cell carcinoma and benign skin lesions. He said it should be approached as an experimental procedure and Low-Beer has reported such a method of treatment. With the safeguards which he uses he has had good results. Great caution must be used in the use of P-32 topical applications near the eyes. Should probably not be done for fear of injury to the cornea and lens. Dr Friedell said that the real objection to the use of P-32 as a topical application is that it needs frequent preparation and calibration. For the use of beta rays a more suitable applicator could be chosen - for example, strontium 90 (Sr-90). - 11 - Dr. Shields Warren stated that Dr. Silverthorn was using P- 32 to locate certain types of brain tumors at Massachusetts General Hospital. Dr. Low-Beer has used the same principle in certain tumors of the breast. It is not certain just how one can differentiate between such conditions and that of increased vascularity with increased P-32 uptake seen in inflammations and certain localized infections. I-131 Dr. Friedell said they were using I-131 (a) to differentiate certain disorders of thyroid function, (b) in locating certain metastatic carcinomata of the thyroid, and (c) in treating patients with hyperthyroidism. The use of I-131 in all of these applications has been most promising. There is a problem in dosage and in estimating probably I-131 uptake. He also said they were studying the normal distribution of iodine by the use of I-131. Dr. Stafford Warren said they were doing the same at Van Nuys, and that results were also quite promising. Dr. Freidell said they were using iodionated proteins to study blood volume. The dosage used is 20 microcuries of I-131. Dr. Friedell stated that I-131 can be used to advantage to tag proteins before they break down, thus permitting certain metabolis studies to be made. - 12 - Dr. Friedell said they were using iodionated proteins to study blood volume quite satisfactorily. Dr. Stafford Warren stated that Dr. Morton at Van Nuys was using I-131 to study both inorganic and organic iodine metabolism in the thyroid. Dr. Stafford Warren stated that Doctors Fink had employed C- 14 and I-131 in filter paper chromatographic studies. The object of this work has been to devise a method for the quick detection and identification of certain "large organic molecules". They have completed their technique for identifying the amino acids and many organic acids by the filter paper chromatographic. They are continuing to study the sequence of simple iodide to thyrozin by I-131 and this method. Fe-59 Limited use has as yet been made of radioiron in any of the Veterans Administration Units. Dr Ross has used it quite successfully in his own laboratory to study the preservation of red blood cells for transfusion purposes. Na-24 May be used in study of peripheral vascular studies. Dr. Roswit at the Bronx has used cyclotron Na-24 to treat a limited number of patients with chronic leukemia. Results seem to have been somewhat comparable to P-32. Pile Na-24 should probably not be used in this manner. - 13 - C-14 Dr. Wood and Dr. Lavik have worked with C-14 at Western Reserve University. Dr. Friedell says it will not be used at Crile until the laboratory facilities are adequate for this purpose. Dr. Lyon stated that Dr. Armstrong's group at Minneapolis were to use C-14 in certain animal studies but not on human beings. V. SPECIFIC PROBLEMS DISCUSSED 1. SHOULD THE DIRECTOR OF THE RADIOISOTOPE UNIT BE A CLINICIAN? Dr. Lyon discussed the problem as it had been encountered during the past year. It was the consensus of the Committee that he should be a clinician, preferably an Internist. 2. SHALL RADIOISOTOPE UNITS ENGAGE IN STUDIES ON BIOLOGICAL EFFECTS OF IRRADIATION? Dr. Lyon requested a statement as to the advisability of a Radioisotope Unit engaging in studies of the biological effects of ionizing radiation, i.e. radiation sickness, radiation injury. Dr. Shields Warren indicated his belief that this should not be done because (1) it belongs to another type of activity than a radioisotope program, (2) requires a different physical set up and staff and (3) requires many animals in an expensive program. He further stated that if they did their radioisotope work properly they would be pretty well tied up with it. - 14 - Dr. Lyon stated it would be difficult, if not impossible, to provide suitable staff for studies of this nature and have them at the same time properly serve the radioisotope program. It was the consensus of the Committee that the Radioisotope Program should not engage in such work and that it should adhere to its primary mission. 3. COBALT 60 Dr. Lyon stated his belief that this was a matter for the Radiology Service rather than the Radioisotope Units since Cobalt 60 may be considered as a competitor with radium for external irradiation purposes. Wherever a Radioisotope Unit exists it could assist in making such radiation measurements as may be required. The Committee concurred in this position. Dr. Shields Warren said that the investigative work was not yet complete and that several more months would be required before the physical characteristics of Cobalt 60 could be realized for purposes of general consumption. It has been used in treating cervical carcinoma. Data is being compiled by Atomic Energy Commission. Work is being done at Ohio State University, University of Michigan and University of Illinois. - 15 - 4. STANDARDS OF DOSAGE, PERMISSIBLE AND OTHERWISE Dr. Lyon pointed out the need for some guide lines. These would be sought from Atomic Energy Commission and other interested agencies, and then forwarded to the various Radioisotope Units. The Advisory Committee may well consider what is appropriate in this line. Example: When is one justified in using 15 millicuries of P-32 in attempts to localize brain tumors? 5. DESIGNATED TREATMENT CENTERS Dr. Stafford Warren: Should there be a consentration of patients in individual hospitals for study or treatment purposes? Dr. Friedell: At the present time we do not have strong enough reasons for advocating the treatment of patients with radioisotopes in preference to other methods of treatment such as x-ray, et cetera. Dr. Morgan: It would be ill advised to officially establish a treatment center for radioisotopes at this time. It was the concensus that no such special treatment centers be officially designated but that Branch Medical Director and Managers could arrange for, or accept, individual patients for research, diagnostic or treatment purposes. 6. RELATION OF RADIOISOTOPE UNIT TO GENERAL MEDICAL RESEARCH It was the consensus (a) that the physical plant of the Radioisotope Unit should be in close proximity to the General Medical Research Laboratory and (b) the activities of the two programs should be closely related insofar as possible. - 16 - 7. RADIOISOTOPE LABORATORY UNIT PLANS FOR NEW CONSTRUCTION Dr. Herbert Allen presented three sets of plans which ave been developed within the Radioisotope Section and are proposed by VA Construction. Central Office as a guide in planning new hospital construction. At the request of Central Office Construction these plans (Enclosure I) where prepared. They have been developed in accordance with the suggestions of a large number of individuals and consultants who have been actively engaged in radioisotope work. The differences in the plans relate to the amount of space,provisionally allocated, i.e. 1935 sq. ft., 1575 sq. ft. and 1210 sq. ft. The purpose of preparing the plans was to provide Central Office Construction with a typical layout for future planning. Such plans do not prevent the local planning group from making changes they believe desirable. It was deemed undesirable to include provisions for "high level" or "hot"laboratory space within VA hospitals. It was the consensus that these plans were acceptable for the purpose intended and Dr. Allen was complimented in his work in connection therewith. 8. DISCUSSION ON CONSTRUCTION PLANS Dr. Long: Would it be advisable to have the radioisotope laboratory proximal to the Metabolism Ward, particularly in planning for a new hospital? - 17 - Dr.Friedell: Satisfactory any place if it is away from the x-ray or radium department. A radioisotope laboratory should be rum safely enough to be run anywhere. Such laboratories can be put in the hospital proximal to the wards and other research laboratories. Make these facilities as close to the other activities with which they are concerned as you possible can. Dr. Allen: There are no windows in some of the counter rooms that I have seen planned. Dr. Friedell: These is no point in having a solid wall and air conditioned rooms without windows. Rely upon proper shielding of sample. Dr. Allen: It is desirable to have two counter rooms? Dr. Stafford Warren: Yes, where possible. Especially where training is underway. One for qualified staff and one for interns and students. Dr. Allen: Discussed construction of hoods and flues. Dr. Stafford Warren: Transite sheets held together by copper joints make good hoods and are not very expansive. They are easily replaced if necessary and simple to construct to individual needs. Metal hoods are much more expensive and not necessarily more satisfactory. Dr. Lawton: With respect to the use of Quonset Huts, it will not be possible within the VA to plan for the installation of laboratories in such temporary structures. There is a firm ruling on this by the Administrator. Alterations and construction will be approved only in permanent structures. - 18 - Dr. Lyon: There seems to be a general feeling that such laboratories should have not less than 25 - 30% of the available wall space (linear measurement minus openings) for hoods. Some place it as high as 50%. Dr. Stafford Warren: A safe is needed in each unit for keeping radioactive standards and radioisotope materials. Such provision should not be overlooked. 9. SPACE REQUIREMENTS - RADIOISOTOPE UNIT Dr. Lyon stated that after discussing the matter with the various consultants it appeared that 2000 sq. ft. the amount proposed by Dr. Shields Warren was the amount of space which should be considered as desirable for a Radioisotope Unit. This desideratum applies to new hospital construction as well. This position was concurred in by the Committee. 10. CONTROL OF CONTAMINATION IN HOODS In a general discussion of this subject, Dr. Friedell pointed out that recently they have been building and using individual wooden "boxes" for this purpose. They are so constructed that if they become unduly contaminated they can be destroyed or stored to await radioactive decay. When used in the fume hoods they prevent undue contamination of the hoods. They are enclosed and have a separate exhause which extends throughout the flue or is connected with an aspirator with an aspirator in which the fumes are trapped (dissolved) in water. - 19 - 11. DISPOSAL OF RADIOACTIVE WASTES Dr. Friedell described a method of disposal which they were using and which consisted in the addition of inert material to the radioactive elements in such a manner that the resultant mixture is relatively harmless. An example:The mixing of non- radioactive strontium with radioactive strontium. Another method of disposing of long-lived radioactive isotopes is to enclose such radioactive wastes in cement blocks. These cement blocks can then be buried or dropped in the ocean or lake and a record kept as to the location of the site. If at some later date it is decided that such a method of disposal was undesirable, the cement blocks could be recovered and the potential hazard removed. This is suitable for Carbon 14. 12. STRIPPABLE PAINT Strippable paint of the type used at USN Radiation Laboratory Hunters Point, California was demonstrated and discussed. Its application on table tops, bench tops and inside hoods as a "removable surface" in decontamination was discussed. There was great interest in this inexpensive device and the rewards concerning its applicability were most favorable. It is planned to send information regarding it to all units. 13. RADIOISOTOPE COMMITTEE WITHIN HOSPITAL It was the opinion of all members of the Advisory Committee - 20 - that there be established within the hospital a Hospital Radioisotope Committee to deal with administrative and professional service matters involving the radioisotope program. The Committee should consist of Clinical Director, Chairman, Chief or Medicine, Chief of Surgery, Chief of Radiology and Chief of Laboratory Service. The Director of the Radioisotope Unit should serve as secretary. Such a committee could serve within the hospital, and be advisory to the Manager and as such they would be parallel to and not take the place of, the Radioisotope Committee representing the Deans Committee. It is desirable that they meet jointly from time to time and coordinate their activities. It is not practical or the Radioisotope Committee representing the Deans Committee to become in matters within the hospital of an administrative nature and for which the Manager is responsible. Coordination between the two committee must be effected. The Hospital Radioisotope Committee may be very helpful in carrying out actions proposed or recommended by the other radioisotope committee. - 21 - Policy and Technical Supervision Administration and (Advisory) Professional Service Within Hospital Deans Committee Hospital Manager Radioisotope Committee Hospital Radioisotope Committee Radioisotope Unit Clinical Director, Chairman Chief of Medicine Chief of Surgery Chief of Radiology Chief of Pathology Director Director of Unit (Secretary) Staff (Dr. Stafford Warren - After the unit is solidly established, this organizational chart should obtain. The dotted lines indicate advisory functions from outside the specific administrative set-up of the hospital. The Hospital Radioisotope Committee does advise the Manager, to whom the Director of the Radioisotope Unit is responsible. If the Manager desires this may be through the Clinical Director or whomsoever the Manager may designate for this responsibility). - 22 - 14. RADIOISOTOPE WARD Dr. Lyon stated that there were many problems arising in connection with the establishment of a ward for this purpose and that a policy with respect thereto was needed. He pointed out that it might be advantageous to combine the activities of a Metabolism Ward and a Radioisotope Unit as far as tracer methodology studies and certain radioisotope therapy activities were concerned. There are certain psychologic and administrative difficulties associated with the establishment of a Radioisotope Ward. It would seem practicable to train nurses and attendants in the dual capacities required in a ward where metabolic studies are to be conducted and where radioisotopes are to be employed in tracer or therapeutic procedures. Aspects of such an activity which require consideration are (a) policy from VA standpoint, (b) nature of the work to be done in such a ward if established (c) source form which funds would come for staffing and implementing such an activity (b) suitable name for the ward, (e) conditions which may be presented as justification for establishing such a ward. Considerations as to item (e) should include such matters as safety of personnel in contrast to the need for avoidance of contamination which while insignificant as far as safety or personnel is concerned may distort background and jeopardize delicate tracer measurements. There is real need for careful collection of samples of urine, and a real need for making suitable care observations of a clinical or laboratory -23- nature. Dr. Lyon pointed out that it was well recognized that accidental contamination in an open mild not be injurious at all to personnel but might be very disturbing in tracer instrumentation whether in diagnosis or research. The collection of urine and excreta is just as important as in other forms of metabolic study. It seems likely that it might be desirable to establish a Metabolism Ward as a part of the Medical Service for the purpose of conducting specialized metabolic studies required in medical research, diagnosis or care. It could also serve as a place for the conduct of such tracer studies as may be required whether for diagnosis or research and as a place were radioisotope therapy could be conducted if special attention be required. As to policy it was the consensus that while it would be undesirable to establish a Radioisotope Ward as such that it would, nevertheless, be desirable to have a facility wherein patients requiring such, could be given specialized attention for metabolic studies, research, diagnostic tracer methodology and in certain instances therapy with radioisotopes. It was the consensus that such a ward should not be called a Research Ward or a Radioisotope Ward or a Radioisotope Ward, but that it could to advantage be called a Metabolism Ward. Dr. Long: Stated that unless such a ward were established it was entirely possible that some difficulty would be encountered in getting the cooperation of some of the professional services. - 24 - Dr. Morgan stated (a) that such a ward should be provided from professional service funds, and not research funds, (b) that the expenses should be distributed throughout the hospital program,and (c) responsible authority should recognize, and favorably accept, the fact that the cost per patient in a VA hospital that maintains such a "Metabolism Ward should be higher than in a hospital that does not to so. He felt that in the end such a ward would actually tend to save money in that it would lead to earlier and more accurate diagnosis, thereby shortening the length of stay of the patient within the hospital. This would tend to lower the cost per patient. Dr. Friedell stated that he did not like to see a Radioisotope Ward set up as an entirely separate unit in a hospital. Precautions should, and need be taken, however, they are not that stringent or that important. From the standpoint of safety such segregation is not essential. Metabolic studies involving tracer amounts of radioisotopes would certainly require so segregation, but in some cases of carcinoma of the thyroid with very heavy doses of iodine segregation might be desirable, but this would not be a problem for the metabolic ward. Dr. Long: If you are doing careful metabolic studies that can not be done on open wards, a special ward is necessary. We are planning to set aside five beds and some special nurses so that three or four nurses will be trained in metabolic work. This - 25 - ward should be under the direction of the Director of the Radioisotope Unit if he is a clinical man. Dr. Morgan: Such a ward should be called a Metabolism Ward. Dr. Long: It is not necessary to have a directive from Central Office. See the manager personally and tell him what you want. Dr. Morgan: Where there is such a ward the cost for patient care is more and the care is more complete. In those hospitals where this is done it costs more for the patients but they are getting better care. A hospital with a Metabolism Ward and a Radioisotope Unit is even better. If this matter were taken to the Bureau of the Budget they would be the first people to realize this. Where there is research there is better and more efficient medical care. Central Office should clarify this with Branch Medical Directors and with Hospital Managers were such wards or units are established. Dr. Stafford Warren stated and the other members concurred in the belief that a Hospital Radioisotope Committee, one within the institution, was required to provide administrative support in professional service matters, in the selection and assignment of patients as well as in the application and evaluation of methods of study and treatment. - 26 - 15. SHOULD INDIVIDUALS RECEIVING RADIOISOTOPES SIGN "RELEASE SLIPS" SUCH AS THEY DO SOME PLACES FOR SURGICAL OPERATIONS OR FOR X-RAY AND RADIUM THERAPY? Dr. Shields Warren felt that they should not because (1) an individual can not sign away his constitutional rights in the eyes of the law and (2) such practices draw and unwholesome attention to the use of radioisotopes. The proper use of radioisotopes in medical practice is encompassed in the normal responsibilities of the individual and of the institution or hospital. Dr. Lyon pointed out that as yet insurance companies do not require an increased rate for coverage for the medical use of radioisotopes as they do for use of x-ray or radium in therapy. He then asked what, if any, bearing the finding of P-32 in the testicles of patients dying with leukemia and who had previously been treated with P-32 ought to have on the need for such a slip. Such a finding was reported from St. Louis. 16. PUBLICITY WITH RESPECT TO ACTIVITIES OF THE RADIOISOTOPE UNITS AND THE RADIOISOTOPE PROGRAM. Dr. Lyon: There is need for some guidance as to publicity. We have felt that until the present time we could do no more than speak in general terms because we have been in such a formative stage, and because the progress within the various units has shown such wide variations. I am anxious for suggestions - 27 - as to policy. Dr. Morgan: The personnel of the VA should be informed before there is any general "public information" activity. They should know first what is going on within their own organization. Then inform the public. The Committee concurred in this position of policy. Dr. Lyon: During the next two or three months it will be possible to disseminate to the VA stations information as to what has been accomplished during the first year and something of the things planned for the coming year. This can be done through (a) VA Newsletters and (b) Technical Bulletins, the letter taking much longer time to carry out. The "public information" program could then be based upon this information and then be released subsequent to its dissemination within the VA. 17. CIVIL SERVICE EMPLOYMENT Dr. Lyon outlined the very formidable position in which we find ourselves. VA has been authorized by the Civil Service Commission to establish a Radioisotope Scientist Series. We do not yet have the technical information required to implement such a program of employment. We are endeavoring to assemble this information as time and effort permit and it is hoped that sometime soon we will have it in the required form. This is not the fault of the Civil Service Commission. It is due to the - 28 - newness of the radioisotopes in applied science and to the difficulties encountered in formulating a clear cut picture of what is desired from the technical standpoint and what standards should be applied. That is why no one else has yet solved it. VA will coordinate with the United States Public Health Service and Atomic Energy Commission in this matter. At the present time, lack of a satisfactory mechanism for appropriate employment of qualified scientificpersonnel under Civil Service presents the most difficult problem with which the entire radioisotope program is faced. 18. ATOMIC ENERGY COMMISSION FELLOWSHIP PROGRAM Dr. Shields Warren gave a brief summary of the three million dollar AEC Fellowship program. Basically $3,000 is allowed for salary, $500 for a wife and $250 for each child. The contracts are for two years and non-renewable. The National Research Council operates the program. Dr. Homer Smith is Chairman for NRC. Dr. Warren stated that four training centers are being set up. One at Denver, one at Portland, one at Rice and one one at Duke. If there is anyone in the VA serving a residency r assistant residency, who wanted to get his special training add work at a special center, and if the program was sound in the eyes of the Advisory Committee, the NRC would be happy if something of that sort could be worked out. Travel expenses are paid to and from the special training centers. Tuition is paid for them insofar as it enables them to gain knowledge from necessary courses. - 29 - It will not be paid for matriculation fees to get a Ph.D. No reason for a man with one doctors degree to go after another. If he is already on a VA payroll no reason to put him on a fellowship program. Question: Is there any financial support the AEC can give the Radioisotope Units? Dr. Shields Warren stated that he thought not other than providing free isotopes. 19. ATOMIC ENERGY COMMISSION HOSPITAL PROGRAM Dr. Warren stated that they were used primarily for cancer work. They have 16 to 18 beds at Oak Ridge. These beds were unused that existed in the Oak Ridge Hospital. 40 beds exist at the Argonne Laboratory. This is actually an annex to the Gold Blatt Cancer Hospital. There are 25 to 30 beds existing at Brookhaven, and like Oak Ridge, these beds were simply unused beds that exited in the hospitals at these stations. The purpose of this small hospital program is for the clinical investigation of selected patients in order that the facilities which exist at the local station can be utilized. There is no conflict of mission between these hospitals and the VA radioisotope program. Both are essential and different in purpose.