Memo to Advisory Board on Medicine and Biology, Subject: Medical Policy

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To: Advisory Board on Medicine and Biology. Subject: aD ICAL FQLICY. It is the desire of the hiedicdl w visor ' s Gffice of the Ca k Riage Directed,Cperations t o present certain matters of medical policy tothe Advisory fioard on Biology and Zeuicine for their consideration. the extremely import at rel sti on ship of health protection and the medical' program top rac tic zl lyall of the CoiMnission activities, and in a larger sense t o national welfare, it is iq erat ive to obtzin basic medical policy decisions as rapid, - as possible. In view of The degree of success which the.Commission's prograin ttahs may well aepend i n a large measure on t h e adequacy ana soundness of s medical, health-physics a d biological programs. Accordingly, thef o1lo;ving questicns ; n ~t ent at ive solutions are submitted f o r your review and expression of opinioc. Dr. xlbert H. Holl ad, Jr., Acting Ledical Advisor of the Gak Ridge Directed Cperations, will be available f o r subsequent meetings of your Board t o provide further information i f rou s o aesire. a. There are approximately twelve cooperating universities participating in the Cak Ridge Institute of Nuclear Stuaies, which is a group established under the laws of the State of Tennessee t o conduct fundamental research using the facilities available at i linton Xational Laboratories. facilities are necessary form ch of the tio io ii cd res ez ch work, a great decil of other work csn be jerformed at the in di - %any competent qualified scientists

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from these universities have applied through this office for funds t o conduct various problem6 i n biochsmical, medical and Slo logical research. Som of these suggested researches are extremelg' pertinent to the activities of the Conmission, as for example, Cr. Alfred Chanutin a t the University o f Virginia 3iochornical Lakoratory wishes to establish a progrsm for the elsctro?hoor.+ic sfud7,r of plasma proteins following irradiation,Ifin his studies he can sst a kli sha constant pattern chanse -.-hich car: 59 correlated with radiation sxposure, we will then 3osses -t ~lstwd i as no stic mt hod which car? rosi i ly he used inthe ? rot action 3f' our prs on nel throuzhout the research, since it i s inten2.d t o attempt t o provide us with a definite answer t o an oxtrenely pertinent problem. . Accordingly, the question arises as t o whether o r not a regional aed ical Advisor can initiate funciacental and/or "progrsmatic" research at facilities within 3is area or wit ! his regior. *-9r thc express purpose of conductin: both fuxia-

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b. A second problem arises when one considers what responsibilities t h e Atomic Energy COnmrission bears for the human administration and institutions outside the ProJect a d (2) when given by physician8 and researchers within t h e Pro&at. category includes contractors ~personnel employing Atdc Energy This question can be subdivided i n t o two phases: When the materials q e administered by private physicians Comrdrldon funds (indirectly) t o perform tracer reidarch, some of which is of no immediate the rap m tic value t o the patient. It therefore becomes desirable to establish acceptable medicolegal or it eri a for future human tracer research. Careful consideration of this problem seems t o indicate that once are c ip isnt ' has been deemed "qualified" by the Isotopes Branch and their advisory committees t o receive and use radioiratopes, the Cammission bears little if my responsibility for human administration. Past medic'o-legal experience provider numeroui instances of claims and suits againstmedl cal in st it u - tions for the use of experimental drugs. In practically every case the physician involved has taken t h e 8010 responsibility and therefore may o r may not be guilty of malpractice, but the institution is exonerated. Thir analogy might well apply t o our present problem. The secmd part of the question i s more difficult since ' much of our research i s motivated by human applloation and human which convened last June, i s accepted i n establishing criteria I f the expressed opinion of the Xedical Board of Review,

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f o r human administration, then obviously a great deal of OUT present human tracer studies must be discontfnaed. facts of t h e case, pro and. con, seem t o be theser (1) Tracer research i a findramental to toxicity studies. ( 2 ) The adequacy of t h e health protection which u e afford our present employees may in a large maiure depend upon in form - tion obtained using tracer techniques. (3) l a and improved medical applications can only be developed through careful experimsnta684 and clinical trial. (4) Tracer techniques are inherent in the ~ dio i ro top ed is tri but ion (1) Moral, ethical and medico-legal objeotionr t o the adndnistratim of radioactive materials without the patlent' s knowledge (2) There is perhaps a great sr rOsp0~16fbilftyif a federal agency condones human @rea pig experimentation. (3) Publication of such researches i n some instances will compromfse the best interests of the Atomic Enereg Colmnission. (4) Publication of experinent8 done by Atomio Energy Cammirslon . gation and be prejudl cia1 t o the proper functioning o f the Atomic Energy Cammission Insurance Branoh. C. The radioiaotope distribution program i s increasing in scope very rapidly. As a result certain questions arise for consideration to (1) What part the Atomic Energy Cods sion Medical Division rill

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day in the isotope po gran ? ;'kat responsibilities does the Atomic Energy Cotrcissicn 'bear for the safe handling by the reci2ient for the more haaarco.2s \ hat responsibilities does the Atonic Snergy Cod sion bear 'dhat part, if any, should the Atomic Energy Cods sion take vdth respect t o cyclotron produced isotoTes a t the various universities throughout the countrj? Answers t o the abcve qces5ions cannot immediately be s e t fortn. Emrever, t ke foil a ~ b gc ments appear in order: should probably Sear complede responsibility for all or' 51s rnecEca1 and h3alth-FhysiCS phases of the Comlr;sion's activities. medical snd health aspects of the isot7pe program therefore is a subject of sone concern t o the :kdica?' 3ikector. other related *fornation nay well. fall xi thin the sco?e cf the The establish er - t as for example, Str on tim 30, Calc im 43 and iarbon lb, =any factors -.rise which ilzcrease tire Uf i cult y of soLti on. These am listed (1) Under the Ator?.ic -&era Act does the Comissfon retain n oral How can the Atcnic ke rgy Com is s Lm ;ro?erly enforce sai'e( 2 )

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( 3 ) The U. S. Public aealkfi Service has no l e g a l authority within state boundaries and therefore can only act in M advisory number of qualified men to initiate such a Public Health sedce. State Public Health officers do have, i n moat instencos, suffl - cie at i ep1 authority t o snforoe 8afe haadling. Further, there does not appear t o be a sufficient men are qualified atthe present time to a88ume thio rsoponsi- (5) The Advisory Field Sen ice of the Isotopes Branch provider isntr hare availed themselves of this service. However, ruggoations or reconunendationr requiring the expenditure of money for laboratory design in the interest of safe practice are not always reoeired in a cordial manner. Radioisotopes with a short half - life, such as Phosphorus, P32 a d do not prerent a severe hazard in mort casea. H&erer, lamb 8Ub8tanCe8 may be of primary concern t o an entire community i f Some system of control is vital i f extensive Intimately associated with t h e above problem i s the question of radioactive waste disposal. As you no doubt are aware, many auggertions have been proposed by ~ ariou speople. Some of there ares (2) Dlsposal by burial. Storage i n vault8 until deoay has progreared to safe limits. A system of garbage can collections and subsequent burial I in federal burial grounds. aminated wastes in suitable

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d. Declassification of medical and biological documents has become a considerable task. All researchers are anxious t o have t h e i r work appear in the journals as soon as possible. men critical process steps or materials are involved the problem is greatly simplified, since all muad abide by secuviolate security, but do cause conrldersble concern tothe Atomlc Energy Cammission Insurance Branch and may w e l l camprdre the publie prestige and beat interests of the However, there a large number of papers which do not Papers referring to levels of soil and water contamination speculation on the future genetio effect8 of radiation and definitely prejudicial to the best intereata of the government. Every such release is reflected in an increase in insurance claims, increased difficulty in labor relations snd adverse public sentiment. Following consultation with the Atomic Energy Commiesion Insurance Branch, the fol lcd ng dec la sri fi cation criteria appears Commission and/or its contraotors are closely aasooiated with atatembnts and inforrmtion which would invite or temd t o encourage claims against the Atomic E!nergy Commission or i t s contractors, If specifio looationa or act i vlt i as of the Atomic Energy Such portions of articles to be published shauld be rsrrorded or deleted. The effective establishment of thi8 policy neo ers it at es revi8W by the Atomic Energy Conrmfssion Inkr-ce Branch, as well a8

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io log ad ladicine, that he have the ities vitlzin his region for the e::?ress

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@%rc-\il consldemtion o f this yroblem sews to indiccte that occe a reciyleiit !.AS See2 deened c pali fie d by t3e Iso tops 3rx:cii and their advisory cor - ~ tte st o receive m d use radioisoto?es, the comission June, is acceTted i n establishing then obvLously cz sreat deal o f our discoztIrzued. Zie rer%!.mnt facts of the case, ?ro a d con, seen t o

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tersomiel nag f'requently be the sonice o f litlga-lion and be ? re judicial tothe proner flulotioning o f the Atonic h rgy Com is si or. ss'zrx1ce

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play in the isotope program? i'lhat responsibilities does the Atanic Energy Comission bear for the safe handling by the recipient for the more hazardous (3) T h a t responsibilities does the Atomic Znergy Connnission bear (4) That part, if any, should the Atomic Energy Coomission take vith respect t o cyclotron produced isotopes a t the various universities throughout the country? Answers t o the above questions cannot inmediately be set fartho However, the follcrwing comments appear in order: It is felt that the Atdc Energy Cod sion Lkdical Division should probably bear complete responsibility for all of the mdical and health-physics phases of the Commission's activities. medical and health aspecls of the isotope program therefore is a subject of some concern t o the bd ical Director.' The establishment of broad general policies of personnel protection, codes, and other related information may well fall within the scope of the With respect t o safe handling of the more hazardous isotopes, as f o r example, Strontium 90, Calcium & and Carbon a,many factors * arise wNch increase the difficulty of solution. These are listed (1) Under the Atomic Energy Act does t h e Commission retain moral responsibility for the application of these substances? (2) Haw can t h e A t & Energg Conmission properly enforce safe

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Uzder the A to iii c5ner a Act does the Cods sion re kin rLor&l