Minutes, Meeting of Subcommittee on Human Applications of Committee on Isotope Distribution Western Reserve University Medical School

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The meeting was called to order by i)r. Hymer L. Friedel l, chairman of Subcommittee on Human Applications a t 9:30 a.m., December 10, 1949, the faculty conference roo= of .testern Reserve University ,lsdical School, hthan 3. Woodruff, s8 Allan Lough. on account of illness. D r c liebersold made some general remarks by way of introduction, partioul a rly for the benefit of the new xriember, Dr. Copp. H e emphasized that there are several reasons why the Commission feels it necessary, a t least for the. present, t o continue t o control the distribution of radioisotopes. Among these reasons are : (1) Possible damage t o persons t o whom radioisotopes are administered; ( 2 ) Radiation hazard t o the users a d associates; (3) Radiation hazard to the gene rd public; (4) The insidious nature of the danger and the permanent character of the Dr. Fail la was not able to attend hen though certain hazards do exist when radioisotopes are utilized, the value of their present and potential usefulness makes it desirable t o promote their employment as vigorously as possi3le. helpful to establish criteria for allocation on a s objective a basis mrily on physical criteria,particularly on permissible dosages t o the recommendations which the four members ofthe Subcomxittee submit regarding individual applications for radioisotopes* It would be The question is whether these criteria should re& pri - If this were donel it would tend t o make more uniform cedure and general policies which @.refollowed by the Isotopes Si vision and the Subcozmittee with respect to applications for the use of radioIn the discussion which followed, Drc.F r i e d e l l pointed out that he had inquired of an m ber of people who serve on coxnittees coinparable t o .this Subcommittee on fIuman Applications (e.g., for allocation of scarce and valuable nex drugs) a6 t o whether these com?ittees operate under definite allocation criteria o la no case did he discover an instance in which definite criteria had been established to govern the work of such committees. Ijr. Friedel l expressed the belief, however, that WhenBWt possib.ble we should establish criteria which would tend to routinize the review of individual applications by the Subcommittee. Iie felt that the Subcommittee itself should b e governed by the phi h soph y which would -&gomote the use of radioisotopes for the benefit of society.

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He emphasized that even x-ray machines cannot be used by just any doctor of medicine without some control being exercised by his fellows. The conclusion t o be drawn from Dr. r ' rie dell ' s remsrks is that while the Suboommittee should relax control as muoh as possible, It appears that some oontinued supervision is desirable and that probably this situation will prevail for some time t o comeo Dr. Holland recornended that the proposed agenda, prepared by Lr. Lough, be aocepted as the agenda for this meetingo agreement with this recornendation. agenda Le adoptedo Dr. Copp moved that the proposed Uro Holland seoondsd this motion, which was carried b Due tothe linxited time available, not all items ofthe agenda were diecussed. The following items were considered inthe order listed : 11, Revisions and Extensions of Present Allocation Irocedure. 6.bo(2) Needles Containing Cobalt 60. 2, Allocation of Radioisotopes to Osteopathic X ospital s14 -4% the request of Dr. Aebersold, Dr. Lough reviewed briefly the general policies under which allocation of radioisotopes for use in human subjeots has been made in recent months. 2, Cowideration of the Harvard Policy Statement,I

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The question was raised as t o whether the Subco,mnittee should formulate and execute a set of' standards siailar t o those ?Ut forward by the Subcommittee on Human Applications ofthe Harvard l:edical School Dr. Holland raised the question as t o whether 0.1 r/day should be the perrnissible value for normal hun;an subjeots, in the organ of highest concentration, or in the nost sensitive tis6uec Dr. kuimby pointed out that such a limitation would prevent the development of diagnostic tests,forin such work tests on agoup of normal controls will always be required. Dr4 Holland rem rke d that he was not in favor of preparing a stateDr' Friedel l felt that to do s o might create too my rigid regulaDr4 fiebersold insisted that a set of standards would be highly desirable, even if not made public a t presento ti ve set of criteria oould be established for the Subconunittee's OWII internal coordinationb A t some indefinite tim in the future the criteria could be modified in the light of experience and published for the guidance of prospective users. A working or tenta - l)r. Friedel l suggested that if suoh standards were t o be formulated, they would require more time than the present meting affords; oonsequeatly, they should be prepared in a report, tothe Subcornittee on Humn Applications, by seleuted Subcornittee members or by a special s&cozx.nittee. 3 e suggested that Dr, Lebersold might appoint e. comit tee of qualified people t o prepare the criteria4 Dr. kebersold was notin favor of this step * He thcugkt that the Subcornittee on Human A;aplications isthe most highly qualified group and that they should prepare a statemant which might be nodified slightly after o on sul t ation with theN at i oral Comit tee on Radiation Pro tea t i on I)r. Quimby pointed out that the MCRP allowance of 0.3 rep/Prk isfor continuous radiation. For any particular investigation, it is necessary t o consider the permissible dose'on the merits of the Dr oF rie dell concurred essentially with 3r. Quinbyls point of view and remarked ';hat it comes down t o deciding whether a given problem is of sufficient importance t o allow a larger amount of radi a tic n

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The motion was mde and passed that Section 1, page 2, o f Supplement No. 1, September 1949, T o Catalogue and Price List 110. 3, July 1949, be modified t o read as f oilows I Administratian of radioisotopes t o humans should always be kept t o the minbum timount required t o aooomplish the objective of the workr Ap?licants who desire to use radioisotopes (beta and/or gamma emitters) i n norm1 P.dults should submit a statemant of the results of anha1 experiments, o r adequate referenoe to the liter at we, concerning the lretabolisni and distribution of the radiomaterials in the form adrcinisteredb In general, the dosage in critical tissues should b e such as t o aonfclrm to the limitations vihioh will be set by the Xational Committee on Radiation Protection. In the interim, however, the dosage tc the crit io al tissue(tissue of maxim un oonoentration) should not exoeed 0.3 rep/wk from single or repeated administration i n normal adults when no therapeutic or diagnostio benefit to the patient can be reasonably anticipated.In special cases, such a6 Iodine 131, however, t h e Subcormittee on Hmen Applications may approve the use of higher tissue dosages* Seotion I S e Norxal Children., Section IIIo Mormal Pregnancy., Seotian Specia!. Pathological Conditions., areto be retained as the expressed attitude of the Subcommitteeo The following motion mas made and passeds (To appesr in minutes only, not for publicaticn) at rao er dose i n normls ofnot more than 50 roicrocuries of Iodine 131 as h organ io iodine, but wii l apFr.vPe up t o 100 microcuries, The Sub cod tte e on Hmen hpplications recomends 11, Revisions and Extensions of t h e Present Allocation Bocedure. A motion was made and passed t o adopt the following policy regarding the allocation of Phosphorus 32. Phosphorus 32 f o r treatment of polycythemia vera and chronio myelogenous leukemia can be allocated to licensed physicians in good standing, under the follow in s plan: a. The applicant must obtain the approval of a university medical sohool, or university hospital, vrhich the Commission has authorized t o use Phosphorus 32 in the treatment o f these disease so The user must have a sui h ble survey instrument..b. C. The Phosphorus 32 must be calibrated by the medical school or university hospital, vjfiich approved the application, o r by a distributor, appruved by the Ssotopes Division of the Atomic Energy Commission.

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Inthe discussion of this a proved state mat of policy, it was pointed out that the university medical school, 3r University hospital, would acoept the responsibility for determining that an individual applicant was qualified to use Phosphorus 32 for the treatment of polycythemia vera or chronio myelogenous instances by making arrangexent for the applicant to visit the responsible institution to observe, or participate in, the use of Phosphorus 32 inthe treatment of these two diseases. Obviously, this muld not be neoessary in those Oases i n which the applicant i s known t o have experienoe as a result of work This responsibility might b e disoharged i n some The Subcornittee expressed the desire that the Isotopes Division obtain inforn;ation from the m ivers it y medioal sohools and ho8pital s on haw this new procedure mrks out in pr act ioe and report to the Sub co witte eat the next two meetingso 7. Str on tiu 900 In zeta-Ray Appficatcrsa The dubcormnittee decided t o consider beta-ray applicators of all kbdsc This would include not only tho ~ ec on tah ing Strontium 90, but a l s o RuthenLwi! 106 or other beta-emitting isotopes which might It was moved and passed to adopt the following plan: as All cca tim of beta-ray applicators will be to a limited number of accredited physicians in good standingo be The Isotopes Division must be satisfied <kat the devices do not leak activity and are generally satisfactory from a health C. The d0sai;e rate of the beta-ray applicators must b e determined and certified by a laboratory app ove d by the Isotopes Division* d. Mo monitoring instruments will b e required. e. 140 local cozrnittee endorsement of the use of the beta-ray applicator will be required* The user will not b e required tobe oonnected with a hospital or large cli nio O Dro iiebersold raised the question of rental versus sale of beta applicators D He pointed. out that the beta sources in thickness gages areat ?resent being distributed only 011 a rental basis. This was encouraged by the Isotopes 3iv5sicn a6 azom $ of controlling

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secondary distribution and waste disposal, but is not a strict requirement. This matter was left up tothe Isotopes Division governs secondary distribution The Conmission's agreement form, however, spec Sic ally 6 .b '(2) Beedles containing Cobalt 60. It was pointed out that Cobalt 60 needles areso cheap that users may tend t o ignore lost needles rather than t o search ror them carefully. In this respect, Cobalt 60 needles vary markedly from radiumneedles. The price of radium needles isso high than when one is lost a thorough search is always madeo It was emphasized, however, that even inthe case of radium needles, the search i o usually abandoned when the amount of moilay involved in the searoh equals o r exceeds the cost of replacement. that every effort should be .-de to in still in the users of Cobalt 60 needles the philosophy that lost needles should be found, in order t o minimize the radiation hazard t o the general publico The qcestion was raised as t o whether the allocation of Cobalt 60 needles should not be liberalized in much the same way a E was d me for beta-ray applicators. Dr. kebersold pointed out that at present there is no standard design for Cobalt 60 needles and that no standard radiation patterns have been published, as has been done for rnilliouriea of Cobalt 60 t o equivalent gama output from radium, the result cannot be expressed directly in milli curies of radiumo further,the shielding from the sheath is different (due t o use of different materials for oonstruction ofthe sheaths), especially at It was generally agreed Although one can oonvert, by calculation,from The Subcornittee en Hcmm jipplications recommends that the Isotopes Division encourage qualified radiology departments t o study adto publish the radiation patterns around Cobalt 60 needleso permit c ons i d er a51e 1i ber a1 izat ion in a1 locat ion h conclusion, it was stated that the bubcomittee recommends that n o change be made in the present policy of allocation of Cobalt 60 6.b.(1) Nul ti curie sources (Cobalt 60) In vim of the limited supply of multi c mie sources of Cobalt 60, the Subcornittee recommends that allocat$ion be lin it ed to recognized medical schools and LEC installations for ex2erimental work. There was s me discussion of the list of individuals and in st it u - t ions that are known t o be interested in using multi curie source6

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Tentatively, the Subcomxittee would b e inclined to look with favor upon applications for multi curie sources of Cobalt 60 from Lro Fail la, Ere Carl Braestrup, Columbia University; i;innesota Xospitals for cancer research r acceptable on further study of formal applications. Others may be The problem of allocation of Gold 198was disoussed briefly. Dr. Friedel l stated that he approves the intravenous use of Gold 198for irradiation of there ti cul o - endo the li al system, but not for local infiltration of tumorse He felt that when local infiltration was attempted with needle and syringe there was too great a hazard of spilling the colloidal material and that this procedure, therefore o was d age rou sO He expressed the belief that the dosage tothe tumor mass could be controlled much ? better with radon seedsn He pointed out that Gold 198 dl1 localize well in liver and spleen {reticulo-endothelial system) For such conditions as lymphomal th s re fore, he felt that Gold 198 could be used satisfactorily o Dra Holland suggested that the Isotopes Ciivision should prepare copies of t h e papers submitted by various userB of Gold 198 and send these to the Subconrnitteea Dr. Friedel l expressed the opinion that the use of Gold 198 i s still in the experinrentEd. stage and that it should be used only where there are enough cases t o be treated to supply interpret able 2. Allocation of 3adioisotopes t o Osteopathic Hospitals This subject was discussed briefly. that if the applying osteopath also has an U ; ~ Odegree and is in good standing in his local medical society, he will be eligible for allocation of radioisotopes t o be used in human subjects a deoision was reached regarding allocation to dootors of osteopathy mho are not also doctors of medioine, Tentatively, it was ooncludod The meetjag adjourned a t 5230 pomo