ML19274D748

Transcript of 781214 Meeting of Advisory Committee on Medical Uses of Isotopes in Washington,Dc.Pp 1-163

ML19274D748
Person / Time
Issue date:	12/14/1978
From:	Collins V, Cunningham R, Griem M NRC - MEDICAL ADVISORY COMMITTEE
To:
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NACMUI, NUDOCS 7902230074
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{{#Wiki_filter:I 1 JR3:jrbl I CR1430 UNITED STATES CF AMERICA 29 NUCLEAR REGULATORY COMMISSION a i , + i THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISCTOPES 5 6' 7' Hearing Room Nilste Building 8 ', 7915 Eastern Avenue, N.W. Washington, D. C. 9-Thursday, December 14, 1978 10, 11 : The Advisory Committee on the Medical Uses of 12 ! Isotopes was convened, pursuant to notice, at 9:15 a.m. g PRESENT: 14, 3 ~, ' Mr. Richard Cunningham, Chairperson Dr. Vincent P. Collins, Member Dc. Frank H. DeLand,' Member 16 Dr. David E. Kuhl, Member

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James L. Quinn, Member l Dr. Henry N. Wagner, Member 18 Dr. Joseph B. Workman, Member Dr. Edward W. Webster, Member 39 Dr. Peter R. Almond,On idArti v i Captain William H. Briner,d M out ,, 0 4 21 l 22 ] 23 lI l +1 l 24 ll Aa-e.e.r n.oo,r.,. w., 25 [4 .t .!j d @9

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jrbl65 2 i Ii C 0 _N _T E_ _N T _S 2 AGENDA ITEM PAGE i ' Opening Comments, Procedures, Introductions 3 Statement, Dr. Chados, NY S tate Dept. Health 11 5 Cardiology Studies, Dr. Wade 14 6' Statement, Dr. Leonard Holman, ACOC 16 7 In-Vitro Diagnostic Studies 42 8 S ta tement, Dr. A. E. Herner, Clinical Radioassay Soc. 44 i Statement, Dr. A. Broughton, American Assoc. Clinical em stry 48 10 ij ! Use of Iodine-131 for Cardiac Dysfunction 72 Use of S tront.u.n-90 in Dermatological Conditions 78 g i Extension of Group I Authorizations 90 13 {l Rule Changes Under Consideration 99 14, Status of Proposed Rules (Mr. Podolak) 114 i ALARA 150 17 t 18 i 1 l i 20 1 21 ;I 22 1 23 ' 24 ' A=-=wsamorms. w., 25 ; f I

3 CR JRS:jrbl 4 1 ' _ _R O_ _C _E _E _D _I N G _S o 2f CHAIRPERSON CUNNINGHAM: It looks like we are pretty 3 well assembled, ladies and gentlemen. 4 My name is Richard Cunningham. I am a member of the 5 Nuclear Regulatory Ccmmission Staf f. 6' I would like to welcome each cf you to this Advisory 7 Committee Meeting on the Medical Uses of Radio Isotopes, an 8 advisory committee of the Nuclear Regulatory Commission. 9 The function of the committee is to provide advice 10, to the NRC Staff with respect to the development of standards and II criteria to assure public health and safety. The Committee i 12 ; provides expert guidance in formulating rules for the regulation 13 and use of radioisotopes in medical research, diagnosis Id - and therapy. 15 This meeting is open to the public in accordance with 16 ' Public Law 92-463. Advance notice of the meeting was published

i 17 in the Federal Reaister on November 1, 19 79.

I would like the 18 record to show that this meeting is being conducted as announced 19 on December 14, 1978, and that the time is 9 :15 a.m. 's 20 I will chair the meeting in accordance with the format

21. described in the Federal Recister notice.

The major purpose 22 lof this meeting is to cbtain advice of the Advisory Committee 1 23 i for the NRC Staff concerning policy matters and rule changes on I a 3 1 the use of radioisotopes in medical research, diagnosis and A*ewetal Reocrats, Inc. 25 ' the rapy. r

jrb2 4 i I I will note that time has been set aside for oral 2 f statements from members of the oublic. We did request a written ., l statement to be provided in acccrdance with the notice in the 4 Federal Register, and those providing written statements will be 5 given an opportunity to also make oral statements. 6' I do ask, however, that in making oral statements 7 that you summarize your statements, and take more than five 8 minutes in making such presentations. The reason for limiting 9 the time, of course, is that we have a rather full agenda; and 10 i time is rather short. \\ 11 ' I will also point out that the written statements, 12 ; the full transcript of the written statements, will be included i I3 in the record of this meeting. Id The meeting is being recorded, and a transcript will 15 be available in the Public Document Room, as well as a summary 16 of events of the meeting. I7 [ In addition to those who have notified us that they 18 wish to make statements for the committee, if there are any others i 19 ' who wish to make statements, we would be pleased to accept them 1 20 within the constraints of time available to us. 21 While the main purpose of the meeting is for the Staff 22 ' to seek advice from the Advisory Committee, and for that reason '3 ' we expect extensive participation by the committee members, we 24 would also invitc members of the oublic who are in the room here A.>,.cere n.co,mi. inc. 25 : to participate in these discussions.

4 jrb3 5 I> In doing so I will reserve tne privilege of the 2 chair to limit such discussions, again the purpose of limiting 3 such discussion is because of the time constraints we have. 4 i Also, we do want to direct the discussion to those 5 matters on the agenda, since the main purpose of the meeting is 6 ' to provide advice to the Staf f in how they proceed, how we 7 proceed, in development of our regulations and policies for 8 ! nuclear medicine. l 9! I would also note that if you make statements, we ask i 10 ;you to use the microphone and to give your name and affiliation; II this is for the reporter, so that we are sure we have a complete 12 ltranscript. The reporter has also notified me that at some point 13 it will be necessary for him to change tapes; so if you see a Id i frantic waving of hands, we will stop the meeting and allow the 15 (reporter to change tapes before proceeding. 'l I0 ' At this time I would like to introduce the members 17 of the Afvisory Committee. I have a list in front of me, and 18 l instead of going arcand the table, perhaps as I introduce the I9 ' l member, he could raise his hand. 20 ; First on my list is Dr. Vincent Collins, from the 21 Houston Institute for Cancer Research. Dr. Collins is a new 22 lmember of the committee, and we certainly appreciate his agreement Il d 23 to serve on the committee. 24 Dr. Melvin Griem, from the University of Chicago, is Ac....cere m.oo mri.inc. 25 !also a new member of the committee; again, we appreciate

jrb4 6 i I Dr. Griem's agreeing to participate on the committee. 2 The other members have served for some time. Dr. Frank DeLand of the VA Hospital, Lexington,

1. ' Kentucky.

5 Dr. James Quinn, Northwestern Memorial Hospital in 6! Chicago. 7 Dr. Henry Wagner, Johns Hopkins Medical Institutions. 8l Dr. Joseph Workman, Duke University Medical Center. 9l Dr. Edward Webster, Massachusetts General Hospital. 10 And two consultants we have at the table here, t 11 ! Dr. Peter Almond, from Ancerson Hospital in Houston, who is our 12 [consultant in medical physics, i I3 i And Captain William Briner, Duke University Id lHospital, who is our consultant on nuclear pharmacology. 15 ' I would also like to introduce members of the -- l 16 lI some members of the -- licensing staff, since many of you have 17! day to day contact with these people through exchanges of I 18 lletters and by telephone, it may be a good idea to associate the i f aces with the names. 20 ; Mr. Bernie Singer, who is Chief of Procedures and 21 ; Certification Branch. 22 Colonel Vandy Miller, who is going to join us -- I 23 hope next week; Vandy is retiring from the Army, where he was 24 Sin charge of radiation protection programs, and will become head Ac....e.rc am>rwri. inc. 25 ! of the Licensing Management Branch. I

jrb 5 7 i I I might point out that we have made some changes in l 2 i our organizational structure this past year to provide better service -- hopefully to provide better service to our licensees. 4 As you will note, when I introduce Mr. Singer, he is in charge 5, of Procedures and Certification Branch; that branch will deal 6: mainly in developing the licensing guides and the policies 7: associated with materials licensing, including nuclear medicine. 8 The Licensing Management Branch will be mostly 9 concerned with the licensing process itself. I would also 10 introduce John Cooper. Dr. Cooper -- oh, there you are, John -- i II ' sorry I missed you -- Dr. Cooper is head of our Regional 12 ! Licensing Program, which is a new program we instituted over the 13 past yea: It's an experimental program. Id He is located in the Chicago area, and the idea 15 beh.'.nd the regional licensing program is to see if we can't 16 provide better licensing service by putting seme of the licensing I7 activities out in the regions. If this proves to be a good move, 18 why, I think we will see expansion of it in the coming years, f I have on my left Mr. Donald Nussbaumer, Assistant i 20 l Director for Material Safety. 21 ! And on my right, Dr. Leo Wade, who is head of the 22 ]! Medical Licensing Section. 23 ] Other members of the licensing organization that you 24 ' deal with daily are Mrs. Pat Vacca; Sam Pettijohn, Nho works vaa.c.,e neoorters. inc. 25 '

with Dr. Cooper in the regional licensing; Dr. Bill Walker, who i

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jrb6 l 8 I who just joined us from the Air Force, where he was for a number 2 of years in nuclear medicine at Andrews Air Force Base; Mr. 2 )I Mike Lamastra; JceDelMedico. And most importantly of these people here, I think, is the secretary for the licensing management 4 3 brach, Marjorie Anderson, who is there to help you make i 6 arrangements if you have travel, arrangements to make reservations. 7! There I think Marjorie can help you a lot. 8; Oh, I'm sorry, I missed one going down my list: i 9 Francis St. Mary, who is also of the medical licensing group. 10 7.m sorry I missed you there in the background. I 'I We have others from our standards development program. 12 lEverybody's here; I think I saw Karl Goller here, who is I3 Director of the Division of Siting, Health and Safeguards. Id There will be some other members of the Standards i 15 ' Development Office who will be making presentations later on. i 16 Housekeeping arrangements: I think that most of you l I7 signed the register when you came in; and you were given badges 18 with I think a "G" or a "K" or something likethat. We ask that I' { you remain on the first floor here unless you are escorted 20 upstairs -- not that we have any secrets upstairs -- i 21 (Laughter.) 22 -- we have a security office that likes to keep 23 ; things ' ery orderly. 24 I might note one thing: we are rotating over the Aa+ecerat Raco,ttes. Inc. 25 next year, we will expect to rotate three additional members

jrb7 9 I I of f the advisory committee, those that served the longest. We 2,1[ have been somewhat derelict in our rotation; and we have imposed 2 on some members far too long. This is an imposition; their 4

time is very valuable, and we appreciate all they've done for us.

5 I think it is only fair to them that we proceed with these 6 ' rotations as scheduled better than we have in the past. 7 ! Therefore, at this time we are rotating three members, i 8l rather than the usual twe Vacancies that need to be filled i 9 j are two nuclear medicine specialists with backgrounds in 10 radiology, and one nuclear medicine specialist with a background I in internal medicine. 12 ! There will be a Federal Register notice published in I3 the near future asking for potential candidates to fill these Id { positions. If you are interested in recommending a candidate I 15 we would appreciate it, and they certainly will be considered. 16 We have, as I mentioned earlier, requested in the i! '7 ! notice of those who wish to make oral statements before the la committee -- we have, if I can find the proper paper -- eight ~*

persons have notified us that they wish to make statements.

20 i For the most part the subject that those wishing to t 21 [make statements cover are directly related to issues to be l 22 covered in the agenda. Therefore, I thought that in order for 23 the statement to make its most impact, what we would do would

1. be have the subject introduced, staff describe the issues as am e.cers neccems. sne.,

25 3 e see it; and then call for the statements by those wishing to 4 h 4

jrb8 0 10 I' i I make statements. 7 There are perhaps two who offered to make stacaments 3 that do not fit into the category of one or two specific 4 issues covered in the agenda. The first one is Dr. Chodos, 5, who is on the Advisory Committee of New York State. He covers 6 several areas. 7 And Dr. Lloyd Bates, who is the American Association 8 ! of Physicists in Medicine, who will cover several areas. I I 9 think that all of Dr. Bates' issues, though, are related to i 10 : issues in the -- that will be covered on the agenda. I might t 11 l ask, is Dr. Bates here? i 12 (Indications of assent.) I3 Dr. Bates, would you prefer to make a general "i statement now, or would you rather make a brief statement on 15

each of these issues you want to cover as they come up?

16 ;h DR. BATES: Yes, that would be fine. 1 II ! CHAIRPERSON CUNNINGHAM: Why not -- I think it would i 18 ' be better, to be more effective for your position, if we covered those issues as they come up. That way the committee could have 20 i a fresh look at your thoughts immediately before them, rather i 21 I than getting them now and we tend to forget exactly what was said. 23 So at this time, Dr. Chodos has some general state-24 ! 3,,,,,,,,,,,j ments covering a variety of subjects; so perhaps I can call on 25 -

Dr. Chodos to make his summary statement at this time.

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jrb9 11 i I All things being equal, we would like to have these 2 meetings in a way that we could all sit around one table and keep them very informal for discussions; but the size of the 4 i group just doesn't permit that sort of thing. I apologize for 5 the rather formal procedures here. 6 Dr. Chados? I STATEMENT OF DR. ROBERT B. CHADOS, M.D., OF THE Of MED7. CAL ADVISORY COMMITTEE OF THE BUREAU OF 9 RADIOLOGICAL HEALTH, NEW YORK STATE DEPARTMENT OF I HEALTH: 11 DR. CHADOS: Mr. Cunningham and members of the 12 i advisory committee for the NRC, I am Dr. Robert Chodos. I am 13 the past chairman of the Medical Advisory Committee to the 14 Bureau of Radiological Health of the State Department of Health, New York, 16 q As you S.now, New York State is one of the agreement 17 States, and we function in support and with the backing and 18 guidance of the Nuclear Regulatory Commission. l I appreciate very much the opportunity to present a I general statement to the -- for the Medical Advisory Committee i 21 l of the State of New York Department of Health at this time. 22 ' This statement has been made available for distribution to the 23; members of the ccmmittee; other appropriate copies are also 24 ' available for these attending. Ac.. m neco,,.i.inc., 25 ' At our recent Medical Advisory Committee meeting i f i

jrbl0 12 i l 1)inAlbanyinNovemberof1978, our agenda included discussions of <l 2 Ovarious proposed regulations, guides and the medi. policy 3 statement; and these documents have been listed in our wric. ten 4 ! statement. I 5' There are other regulations, guides and other state-6 l ments that are not identified in the written statement which we 7 have reviewed in the past, some of which we have made comment o t l 8 to the Nuclear Regulatory Commission in writing. 9' In our discussion there was initially relative to the i 10 ' documents cited in our written statement, a comment or a number II of comments about the proliferation of these regulations and 12 guides; and some concern was expressed at our meeting as to their i 13 lpotential impact on carrying out nuclear medicine programs Id l effectively. 15 i Our committee recommended that this concern be 16 lpresented to the NRC Advisory Committee, l and this has been so 17lindicated in our written statement. 18 ! On further discussion it became evident that our I I9 l committee was actually more concerned with a number of inadequacies' 20 j and inconsistencies that appeared in certain of the proposed 21 regulations and guides as published. And the committee indicated 22 the need in their judgment to carefuly review and revision 23 !c: some of these documents. 24 [ These viewpoints have been so expressed in previous Awescerse Reoorters. IM. 25 ! correspondence with the Nuclear Regulatory Ccemission, and are i l I

13 jrbil I, available on file. And this particular reference is again i 2 included in our written statement. 2 In addition to that, we have again identified in the 4 Statement that we presented to you, the particular items that 5 we feel need further review. 6 Our committee has not expressed an opinion in writing 7 concerning the medical policies statement that has been under 8 discussion for at least a year or more. The most current version 9l or presentation that was available to us was dated October 1977. 10 To my review of this particular document, and we i i II ! reviewed very recently, it incressed me as a r.ost reasonable i 12 land thoughtful presentation. We shall look forward to today's 13 discussions as to the present status of this most important 14 document which will serve as a guide, I think, for many of the 15 functions of the Nuclear Regulatory Commission's operation in i 16 ! the immediate future. Il 17 ! Again, I thank you for the opportunity to appear i 18 and to make a general statement. 19. (The full document follows:) 20 21 22 h l 23:l 24 Ace cocerel Reoo,rers. Inc., 2b I l

Ckades STATEMENT FOR "EDICAL ADVISORY COMfi"' TEE OF THE BUREAU OF RADIOLCCICAL HEALTH. NEW YORK STATE OEFART'4ENT OF HEALTH This statement to the Nuclear Regulatory Commission's (NRC) Advisory Committee on the Medical Uses of Isotopes is made on behalf of the Medical Advisory Committee (MAC) of the 3ureau of Radiological Health of the New York State Department of Health (see Attachment I for a list of members of the Medi:a1 Advisory Committee). During the past year, our Medical Advisory Committee has had the opportunity to review NRC's medical policy statement, as well as Regulatory Guide 8.18 and NUREC-0267, Ensuring That Occupational Radiation E::posures at Medical In-stitutiot.s will be As Low As Reasonably Achievable - ALARA. Our comments on the ALARA guide have been submitted to NRC and are on file. At the recent annual meeting of MAC there was discussion of 10 CFR 35.33,MisaJministration Reporting Requirements; of Regulatory Guide 8.20, Application of Bioassay for I-125 and I-131; of 10 CFR 20.407, Report of Annual Personnel Exposure, and of the NRC medical policy statement and the ALARA guide and NUREG. Our Medical Advisory Committec appreciates and supports the need for appro-priate policies and regulations. However, it was the Committee's opinion that certain of these proposed regulatione and guides are in need of further re-vision and clar.ification. The Medical Advisory Committee has indicated its general agreement with the October 4, 1978 statement submitted by the Society of Nuclear Medicine on 10 CFR 35.33, Mijadministrations and has supported the Society's opposition and that of New York State to this regulation, as published. The Committee noted that there are existing hospital policies for handling mi$administratiens in-ternally and these hospital incident reports are available for NRC/ State in-spectors. The Committee and the Bureau of Radiological Health will make every effort to decrease the incidence of misadministrations by encouraging the use of color coding systems. The Committee felt that the ALARA concept is dppreciated and utilized in the radiation safety programs of most institutions. Regulatory Guide 8.18 can cer-tainly be helpful to such programs in implementing Commission regulations. How-ever, the Committee indicated the guide might benefit from careful review and ed it ing. Some of the problems with this guide were identified in the letter of March 14, 1978 from the N.Y. State Bureau of Radiological Health to the 6ffice of State Programs, NRC. n The Committee also agreed with the concept in Regulatory Guide 8.20 on Bio-assay for I-125 and I-131, but found it confusing. This guide would require care ful revision and clarification if it is to be implemented successfully. In conclusion, there was concern expressed by members of the Medical Advisory Conmittee on the increasing number of regulations, some of which may not be ef fective on a cost / benefit basis. The need for careful review and revision of certain of these regulations and guides has been emphasized in-this state-ment. May I express our appreciation for the opportunity to attend and to contribute to the deliberations of your Ccmmittee. A D d h d en - Robert 3. Chodos, M.D. Past Chairman, MAC December 14, 1978

ATTACHFINT I MEDICAL ADVISORY COMMITTEE 1973 BUREAU OF RADIOLOGICAL HEALTH NEW YORK STATE DEPARTMENT OF HEALTH Leslie L. Alexander, M.D. Philip M. Johnson, M.D. Director of Radiology Prof. of Radiology Queens Hospital Center Director, Nuclear Medicine Division 32-68 164th Street Columbia University Jamaica, New York !!432 630 West 168th Street Appointment Expiration: September 1982 New York, New York 10032 Appointment Expiration: September 1982 Edward Graham Bell, M.D. Director, Nuclear Medicine Department Harald Rossi, Ph.D. Crouse-frving Memorial Hospital College of Physicians and Surgeons 736 Irving Avenue Columbia University Syracuse, New York 13210 630 West 168th Street Appointment Expiration: September 1982 New York, New York 10032 Appointment Expiration: September 1973 Monte Blau, Ph.D. Nuclear Medicine Department David A. Weber, Ph.D. Veterans Administration Hospital Division of Nuclear Medicine Building No. 5 Strong Memorial Hospital Buffalo, New York 14215 601 Elmwood Avenue, Box 620 Appointment Exp: ration: September 1931 Rochester, New York 14642 Appointment Expiration: September 1973 Robert B. Chodos, M.D. Committee Chairman Prof. of Medicine and Radiology Albany Medical Center Hospital New Scotland Avenue Albany, New York 12203 Appointment Expiration: September 1978 ee

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14 i 1j CHAIRPERSON CCIMINGHAM: Thank you very much, 2 Dr. Chados; your comments are well taken; and we look forward to 3 reviewing your written comments. 4, As I said, we have a new Procedures Branch and 5-one of the purposes of this branch is to look at man 7 of the 6 regulations and guides that are currently out. We acpreciate 7l your participation. Thank you. 8I Before beginning on some of the discussions of the 9l medical matters, I would suggest perhaps now it's 9:35, perhaps 10 we should break for lunch about 11:45 before the restaurants Il get really full, and reassemble here about 1 o' clock. 12 l We would hope to cover most of the clinical issues 13 in the morning, and I know that some will be leaving in the i i 14 l af ternoon; but we will continue the meeting and try to get throuch 15 i the whole agenda. I 16 ! Wi th that, I think we can proceed with the cortion of 1 1 17 lthe agenda on medical issues; and I would like Dr. Wade to i l 18 l i: troduce those issues. i 19 j The first issue is the radioisotope training and 20 lclinical experience requirements for cardiology studies. And I i 2I!see in my notes here that Dr. Holman and Dr. Johnson will also 22 an t to make statements on this issue. u 23 f DR. WACE: Okay. 24 i As often happens with these iters we seer -- it seems ac,.r.c n.comn, inc., 25 !that we don't hear anything about them for a while, and then we I

irbl3 15 l l i I ! get one inquiry and that's quickly followed by several others. i 2f We have been approached by a nunber of necole in the last several weeks and asked about our training criteria for -- 4 our training and experience criteria -- for cariologists who want 5 to do nuclear cardiology studies. 6 The issues to consider here are that, on the one hand, 7 i we have training a ni experien:e criteria outlined in our medical I 8! licensing guides; there is a statenent i' there that says l 9 that we will consider on a case by case basis those physicians 10 who want to do just one or two studies. And so we have to look 11 at these studies and see what is involved. 12 It is our understantling that nuclear cardiology 13 studies are becoming very popular, a lot.of people are becoming Id interested in doing them. They can involve any number of 15 ' radio-pharmaceuticals, including thallium-201, which we do not 16 lregulate; it's not byproduct material; but may involve I7 ! techne tium-99m, labeled human serum albumin, or labeled red cells l 18 lby use of stannous pyrochosphate: and in some cases perhaps l 19 - =e l using technetium-99m labeled albumin microspheres injected via 20 l cardiac catheter. i 21 ! It's also our understanding that these may involve i 22 the use of Group III kits and generators, and handlina essentially 23 ! of relatively large quantities of radioactive materials. 24 Aes.rocerat Reco,ters, Inc. ; I guess, that we Uhat we would -- the cuestions, 4 25 ' would like to have answered by the committee -- first of all,

jrbl4 16 1 is the type and quantities of materials handled and t.2 /HngFs 2 'I , procedures significantly less than general nuclear medicine studies to warrant reduction in the training requirements for 4 basic radioisotope handling techniques. 5 The second question we would like to have answered 6, is what type of clinical experience should be required? Any i 7! specifics on time, or the number of studies? 8 He have recently send a questionnaire to our 9 advisory committee, but they haven' t vet had tine to respond to 10 that in writing. 11 ' Okay, those are the questions we would like to 12 have answered, and now do we have some people to talk about it? 13 l CHAIRPERSON CUNNINGHAM: Yes. i Id i If I may ask Dr. Holman, who wants to make a statement 15 ' on this subject? 16 I STATEMENT OF B. LEONARD HOLMAN, M. D., ON BEHALF OF I7 ! THE AMERICAN COLLEGE OF CARDIOLOGY: 18 [ DR. HOLMAN: Members of the Advisory Committee on I 19 ; the Medical Uses of Isotopes, ny name is Dr. Leonard Holnan; ,o 20 ; I am Chief of Clinical Nuclear Medicine, Peter Bent Brigham i 2I ospital, Associate P.-ofessor of Radiolocy, Harvard Medical '2 hSchool; I represent The American College of Cardiology, which i N 23 'is a professional medical s,ecialty organization of more than 24 j'8,500 physicians and scientists who specialize in heart disease w.e mi n.oo: m s.inc., 25 ;and other closely related disorder.

Presentation of B. Leonard Holman on behalf of The American College of Cardiology Before the Advisory Committee on the Uses of Isotopes of the Nuclear Regulartory Co= mission w December 14, 1978

I Members of the Advisory Committee on the Medical Uses of Isotopes: My name is B. Leonard Holman, M.D. My credentials are the following:

1) Chief of Clinical Nuclear Medicine, Peter Bent Brigham Hospital, 2) Associate Profersor of Radiology, Harvard Medical School, 3) Established Investigator, American Heart Association, 4) Diplomate, A=crican Board of Nuclear Medicine, 5) Diplomate American Board of Radiology (Diagnostic Radiology), 6) Fellow, American College of Cardiology,

7) Member, American College of Nuclear Physicians and American College of Radiology, e x Mr.& e_

8) Research and clinical practice in cardi;;;;-alen nuclear medicine for the past nine years.

I represent the American College of Cardiology, which is a professionsl 4 medical specialty organization er more than 8,500 physicians and scientists who speciali:e in heart disease and other closely related disorders. On behalf of the College, I,would like to express my gratitude for the opportunity to present cur views /-1 CcM -d p sto this distinguished ce=mittee. I would like to address two issues & C.o / 6 5c< today. 1) I would like to present ses views regarding training requirements for 3 '

c. m & a c.-

physicians limiting their handling of byproduct material to erreim.ascmicr-applica-tions, and 2) I would like to urge that cardiac dysfunction not be deleted as an ir.dication for I therapy. The decision as to whether the Nuclear Regulatory Commission establish an abbreviated curriculum for the licensing of physicians who limit themselves to 2 -m~ eard**"'amil,r applications of radio-tracers is an important one. The sub-specialty . ca G a of cardiare:cular nuclear medicine has undergone remarkable growth in the past five =w years. The number of cardiovascular imaging studies at the Peter Bent Brigham Hospital has increased from less than 5% of all nuclear medicine imaging procedures five years ago to over 30% at the present time. Other major teaching hespitals have experienced similar growth in the field. It is my opinion that this growth rate will continue for the foreseeable future in both hospitals affiliated with teaching institutions and in cemmunity hospitals as well. Indeed it is in the latter group

II .o - ~.. u that we may expect to see the greatest growth in c'edi-"eccu?-e-nuclear medi:inc r- ,s a - s over the next several years. Cardiev;;:_12r nuclecr medicine is therefore a major component of nuclear medicine practice and might reasonably be expected to increase J in size and scope in the future.

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c; At the present time, the Nuclear Regulatory Commission requires the following - ;L; s physician training to justify licensing for the medical use of byproduct material: US' 'd 2,/} _ i [ a) Two hundred hours of training in basic radioisotopic handling techniques, b) ] Five hundred hours experience with the' types and quantity of byproduct material f L i%. e ~ ") for which the application is made, c) Five hundred hours. of clinical. training inc. 6 < ? ' j ) J u. eL% < ~ ~. < a supervised institutional nuclear medicine program.3 A decision to abbreviate these training requirements for physicians limiting their use of byproduct met-vial to

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diagnosis of cardiac disease (cardiv,ecc.icr nuclear medicine), must take into account two important but counterbalancing considerations. First of all, the types of procedures performed in cardir.c applications are, of course, smaller in number than the types of applications required for general training in the med_ical use a_,a ~ ~ of byproduct material. At the present time, a specialist in cardic'J:ccu12r nuclear medicine performs the following types of procedures:

1) equilibrium gated radio-nuclide ventriculography

(' *Te labeled albumin or red bicod cells), 2) first transit radionuclide angiocardiography ( "Tc pertechnerate), 3) acute infaret scintigraphy ( 'Tc pyrophosphate), and 4) =yocardial perfusion scintigraphy (thallium -201). (While thallium -201 is not a byproduct material and does not n specifically fall within the regulations ot' the NRC, I have included its medical aA~ use to more accurately define the domain of c2rlir"2 ular nuclear medicine and to more appropriately ccament on training requirements in that sub-specialty). A large number of procedures and radiopharmaceuticals would therefore not be included within the do=ain of this sub-specialty, suggesting that some form of abbreviated training would be appropriate.

III On the other hand, it must be noted that training in the basic handling and clinical application of radioactiva tracers requires an essential body of knowlege which is general in nature and which requires the same exposuti to didactic and clinical experience whether the potential licensee proposes to use two or twenty medical applications of byproduct materials. Furthermore, most of the applications cu .w. u. which fall within the domain of enrdic" e-"- nuclear medicine are technically complicated with regard to the sophistication of instrumentatica and equipment, with regard to data acquisition and processing, with regard to patient monitoring and imaging techniques, and with regard to the high doses required for the proper performance of these examinations. Indeed, these techniques are, in my opinion, the most technically difficult of all nuclear medicine procedures to perform properly and require the largest reservoir of knowledge with regard to anatomy and patho-physiology for proper application and interpretation. cm ey ~ I ould Gb to provide the cccmittee with my c; inion c6ncerning the minimum requirements necessary for training a physician in the use of byproduc ' material c_. u.m ~ e, for umidiv <aau Isr nuclear medicine applications. Thi cpinica iu L;;cd er 27 - experiene: e cr tb>,naa a4 k 3 t ye2r in training moide;,t3 auu ;ellv s zu mardio-vasculau uuclear =ed.c.ne um mL; Pcter 32nt 3 ri gham-lios pie:rlT-Bos t on,- Ma s s a chu s e t t s. 1-h. - fc;nd th2: dn individual with a background in car,diology, nuclear medi. cine, em L, a-y9 w n G a or radiology can be adequately trained i- ' tce ment r**g*, if the program is b intensive, including exposure to both lectures and clinical experience in radio- 'e isotope handling techniques and to the technical and interpretive aspects of the procedures the=selves. I aave fumudthst,'[obesuccessful,theprogrammustinclude approximately the sa=e curricul m in the basic radioisotope handling techniques as is required for the general training of physicians in nucle ar medicine. This is

c. x A c-e because the complexity of the cardic::::ular nuclear medicine subs;= _

'*y-is such that a thorough grounding in instrumentation, radiation protection, radiation biology, generator production and radiopharmaceutical preparation is necessary for the proper

IV (6.ik opplication of these techniques. 4 also require clinical experience, which must include the following categories: 1) gated equilibrium radionuclide ventriculography (using either "Tc albumin or red blood cells) in the evaluation of patients with coronary artery disease (prizary) and in patients with acute myocardial infarction, cardiomyopathy and valvular heart disease (secondary), 2) first-transit radionuclide angiocardiography (with Tc pertechnetate) for the evaluation of patients with coronary artery disease and in patients with left-to-right intercardiac shunts of the great vessels, 2)infaret avid scintigraphy (with b e pyrophosphate) in patients with acute myocardial infarction and 4) myocardial perfusion scintigraphy (thallium -201) in patients with coronary artery disease (primary) and acute myocardial infarction, congenital heart disease and right ventricular overload (secondary). It is important that the trainee have experience with myocardial perfusion sciatigraphy and/or radionuclide ventriculography and/or first-transit radionuclide angiocardiography performed during or immediately af ter exercise in Our program -4 e - 6 / 1 the evaluation of patients with suspected coronary artery disease. require [thattraineesbethoroughlygroundedincardiacanatomyandphysiology,and the trainees are expected to supervise the examination of patients prior to imaging to determine their suitability for a particular radionuclide test. The trainee also obtains clinical experience in determination of the adminictered cose, the calibration of the dose and the administration of the dose to the patient. The clinical training also includas supervised exoerience in the technical aspect of the ,e imaging procedure including the application of exercise testing w'.ere indicated, electrocardiographic gating where indicated, imaging techniques, ad computer techniques required for image acquisition and processing. Also included in the training program is the supervised interpretacion and reporting of the procedures h - ~=.~ V L u l Cwh - It is therefore & ) cki thegenvaltrainingguidelhnescanbe my opinionithat c_ wu.s e_. abbreviated for physicians limiting their nuclear medicine practice to cardi;- v:rsetrhr applications. Category A (training in basic radioisotope handling techniques) e-

a Y' L Hf AA) V should be adjusted only slightly since the information is general and necessary to the appropriate practice of cardiovascular nuclear medicine. Categories 3 and C (experience with the types and quantities of byproduct material for which the application is being made and supervised clinical training in an :astitutional nuclear medicine program) can, in my opinion, be abbreviate.d to be, included,in an m ..< w. l.g +" p ws.:. K -- ~ ~ m. _ = Y-L' eif e ~ k % nsive(training program of the type described above. The Nuclear Regulatory Co= mission is also concidering the possibility of deleting as one of the potential applications of I therapy its use in cardiac "1 dysfunction. T therapy for the treatment of patients with angina pectoris was introduced approximately thirty years ago by H.L. Blumgart and his colleagues at Harvard Medical School. Its use for this condition and for the treatment of arrhythmias has been largely replaced with the introduction of other pharmaceutical and surgical managements. At the present time, the pplication of I therapy in euthyroid patients for the treatment of intractable angina pectoris or for t e h treatment of arrhythmia is rare. I have consulted with several prominent clinical cardiologists at the Harvard Medical School who, nevertheless, find that there are euthyroid patients in their practice in whom I is the preferable therapy for intractable angina pectoris or for arrhythmia. While they are using this mode of therapy only rarely, these physicians would find alternative modes of therapy in these patients less attractive and would therefore consider the deletion of cardiac dyetunction as an it.dication for I therapy as having a detrimental effect on w their professional prerogatives in those rare patients in which such treatment is l preferred. On the basis of the experience of those physicians using I therapy c %. for cardiac dysfunction, allbeit rarely, 4-recoc=end that cardiac dysfunction not be 131 deleted as an indication for 7 g.nerapy.

VI I wish to thank the Committee again for an opportunity to present my views. Sincerely, w a. Om av B. Leonard Holman, M.D., FACC Associate Professor of Radiology,

arvard Medical School Chief of Clinical Nuclear Medicine Peter Bent Brigham Hospital, Boston, '.fa.

9

jrbl6 17 t I At the cresent time the Nuclear Regulatorv Commission 2 requires the folle"ina physician training to justify licensing for the medical use of byproduct material: 4 Two hundred hours of training in basic radioisotopic 3' handling: 500 hours experience with types and quantity of 6 by product material for which the application is made: 500 hours 7{ of clinical training in a supervised institutional nuclear 8 medicine prograr.-- and at the present tine such training can be 9, obtained emperically in a properly intecrated three months 10 l program. i 1 1 A decision to abbreviate these training requirements 12 lfor physicians limiting their use of byproduct natorial to the i I3 ! diagnosis of cardiac disease must take into account two important,- i 14 I ! but counterbalancing, considerations: i 15 First of all, the types of procedures performed in 16 1 1 cardiac applications are, of course, smaller in nunber than the 1 I7 types of applications required for general training in the "[ medical use of byproduct material. At the present time a specialist in cardiac 20 nuclear medicine performs essentially four tyres of procedures; 2I!ta large number of procedures of crocedures and radiopharmaceuticals

l 22 lwould therefore not be included within the domain of this 1

23 ] subspeciality, sugcestino that some forn of abbreviated training 24 would be accropriate. w.m.c neoo,mi. ine., 25 ' On the other hand, it must be noteJ that t::aininc in i 6

jrbl7 18 I the basic handling and clinical apolication of radioactive 1 2ftracersrequiresanessentialbodyofknowledgewhichisgeneral 2,in nature and which require = the same exposure to didactic d and clinical experience, whether the potential licensee precoses 5 to use two or 20 medical apnlications of hyproduct materials. 6 Furthermore, most of the applications which fall 7 i within the domain of cardiac nuclear medicine are technically 3l complicated with regard to the sophistication of instruments 9l and equipment, with regard to data acquisition and processino, 10 patient monitoring and imagine techniques; and with regard to the II higher doses required for the proper performance of these 12 le::aminations. i 13 ! I would like to provide the committee with our i i Id : opinion concerning the minimum requirements necessary for IS trainina a physician in the use of byproduct material for 16 cardiac applications. I7 I An individual witn a background in card.iolog", i 18 lnuclear medicine, or radiolocy can be adecuately training in i"! cardiac applications if the program is intensive, including 20 ; exposure to both lectures and clinical experience in radioisotope 21 handling techniques and to the technical and interpretive aspects 22 l:!of the procedures themselves. 23.ll To be successful, the program nust include acproxi-lIl aj matelv the same curriculum in the basic radioisotooe handling ac....e.,e seconm. inc. 25 i. techniques as is required frthe general training of chysicians

jrbl8 19

1.lin nuclear medicine.

This is because the comple::ity of cardiac 1 42 [ nuclear medicine is such that a thorough grounding in instrumentation, radiation protection, radiatien biology, 4 cenerator production and radiopharmaceutical preparation is 5 necessary for the proper application of these techniques. 6' It will also require clinical experience which 7 must include the following categories: i 8; Gated equilibrium radionuclide ventriculography; 9' first-transit radionuclide angiocardiography; infaret avid 10 scintigraphy; and myocardial perfusion scintieraphy. 11 It is also important the trainee have experience i 12 lwith inniging performed durine or immediately af ter exercise, i I3 The program should require that trainees be. thoroughly 14 i grounded in cardiac anatomy and physiology, and trainees are i 15 expected to supervise the examination of oatients prior to i 16 imaging to determine their suitability for a particular I radionuclide test. 18 The trainee must also obtain clinical experience

in determination of the administered dose, the calibration of 20 the dose, and the administration of the dose.

21 ' The clinical training should also include 2 supervising experience in the technical aspect of the imagine 1 23 -

procedure, including application of exercise testing, 24 electrocardiographic gating, imagine techniques, an2 computer AM PCFW Repormes, f x.

25 technicues. Also included in the training procran is the

jrbl9 20 l i i I' supervised interpretation and reporting of the procedures. 20 It is therefore the opinion of the Ametrican College of Cardiolocy that the general training guidelines can be 4 abbreviated somewhat for physicians limiting their nuclear nedi-5, cine practice to cardiac applications. 6' Category A - training in basic radioisotope handling 7 techniques, should be adjusted only sichtly cince the 8 information is general and necessary to the aopropriate practice 9l of cardiovascular nuclear medine. 10 l Catecories B and C - experience with the types and II ! quantities of byproduct material, for which the application is 12 lbeinc made, and supervised clinical training in an institutional, 13 nuclear medicine program, can, in my opinion, be abbreviated to i Id j be included in a properly integrated two-month traininc 15 program of the type described above. I 16 lIr. Cunningham, the College would also like to i d 131 17 comment on I therapy; would you like me to do that at a 18 i later time? I CHAIRPERSON CUNNINGHAM: Yes, I had that notation on 20 lmy agenda, Dr. Holman; you can comment on that later. 2I DR. HOU1AN: Then at this time I wish to thank the 22 committee again for an opportunity to speak. I 23 ll CHAIRPERSON CUNNINGHA'!: Thank you very nuch, 24 ' Dr. Holman. Your views are very helpful. ac.4.cer neoorters, inc., 'S I also have Dr. Philip Johnson, recrosentin' the i t

jrb20 21 1 Ame rican College of Nuclear Medicine, who wants to make a 2 statement on this subject. 2, STATEMENT OF DR. ?HILIP JOHNSON, ON BEHALF OF THE 4 A>'ERICAN COLLEGE OF NUCLEAR 2CDICINE: 5 DR. JOHNSON: Mr. Cunningham and Members cf the 6 Committee, Staf f, and members of the oublic which I represent, 7, the American College of Nuclear Medicine submitted a resolution 8[ the committee has before it because at its recent combined 9! meeting with the American College of Nuclear Physicians, cur 10, members, the cardiologists and their respective institutions, l lI ' had open discussions concerning the future location and control 12 i of the institution of nuclear cardiology activities. What I mean i i 13 by that is scanning, thalium, wall motion and injection oractices. I 14 The proposera suggested that these activities should i 15 ; be located within the cardiac catheterization laboratories to I 16 enable direct catheter injection of radiopharmaceuticals, and/or 17 nuclear cardiology should be located in the stress testino 18 ! laboratories. l 19 i In those locations nuclear cardiology could be 20 ! administered more efficiently by the cardiolocy section. In the i 21 ; opinio.1 of the cardiologists that their physical nresence is l I 22 needed during stress testing for patient safety, and that nuclear i 23 : medicine physicians are not training in cardiac monitoring i 24 or resuscitation techniques. Ace receeW Reoo,ters, Inc., g 25 ' The interested cardiologists could readily letin when

ib21 22 Ilto order and how to interpret the nuclear medicine procedures. i 2 3 He could rely on well trained registered nuclear redicine 3 technolocists to operate ecuipment and to administer and 4, orepare the radiocharmaceuticals. 5 His lack of knowledge concerning NRC rules and 6 ' radiation safety could be evercome by re ;1ar visits of the 7i radiation health physicists who overseee laboratory safety of i 8' nuclear medicine, radiology. I t 9! In a related develognent, we in the academic 10 institutions are becinnine to see an awakening Cesire by the i II ' neurologists to be gcuen. car scanning in their research 12 l laboratories. The arguments are the same as those of the I 13 cardiologists, except for the radionuclides proposed, and the i Idpanatomicalpart imaged. I 15 We have here a well meaning but somewhat niave i 16 ; attempt to fractionate nuclear medicine testing into multiple -\\ I 17 departments and laboratories. This inevitably will lead to i 18 lincreased costs, greater potential for accidents, and even delayed i 19 - nuclear medicine procedures as the residual activity from one 'e 20 ; group interferes with a second or third grouo. 21 : The practice of nuclear cardiolocy recuires large 22 ' poses of radiopharmaceuticals; for e:: ample, N edd li 23 fBtudies are routinely used for 20 millicurie injections before 24 nd after exercise, for a total of 40 millicuries per patient aa-ac.i neoomn. inc. k; 25 n one day. Kit preparation and use is common practice

jrb22 23 f I Since it is desirable to keep the radioactivity within the 3 2[; vascular space. Many heart patients are too sick to come to the ,1 laboratory; thus, the significant nercentage of studies are done 4 at the bedside, with the dose brought to the bedside, and the 5 injection an

1. nr-~'

i- =n itnrestricted area. 6 2M&:n , which uses 15 to 20 millicuries 7l per dose, may be needed on a daily basis during critical phases I 8 of a patient's disease, causing daily exposure to the patient 9l in the next bed and nursing personnel. 10 Equipment used is sophisticated, the most modern i 11 1 available. It is also versatile so that a cardiologist licensed 12 j to perform only nuclear cardiology will largely begin doing his 13 lnuclear medicine studies (unintellioible). 14 j We expect this to becoma a big business, with 15 manufacturers of imaging equipment jockeyinc fer sales. The 6 push to provide quickie courses for cardiologists untraininc 17 ! in nuclear medicine techniques and radiation safety will become i 18 l overwhelming. 1 This could only lead *o a monumental regulatory problem. 21 ' With the ohysicians responsible for the nuclear 22 h!! medicine testing which use the larcest doses, most frequent l 23 ! j testing per individual, and the most use in unrestricted areas, 24 having the least training in the field of radiation safety, 4..,,,, n,,,, %,, 25 '

instrumentation, radiocharmacy and nuclear medicine.

t

jrb23 24 I li Certainly there is a close sinilarity of function 2 l and need between radiology and nuclear medicine. There is some 3 justification then for having one individual with the combined 4 duties. 5 This sicilarity of training does not c::ist between i 6 cardiology and nuclear medicine, or neurology and nuclear medicine. 7 It is therefore a different type of problem and not aoplicable 8 to the restricted license or the restricted short-term traininc. 4 9l And therefore, the Cc11ege submitted the resolution 10 you have before you. II l CHAIRPERSON CUNNINGHAM: Thank you very much, Doctor. 12 ' (The full docunent follows:) 13 14 l l 15 l 16 I 17 I 18 l 19 l i 20 21 i 1 I 22 II I 23 'l 24 ' Ac..ew neoomes, inc. 25, l

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jrb25 25 Il Do you 'fant to complete the discussion here? I think 2 [ the first issue would be the training requirements for cardiologists. 4 DR UADE: Well, yuh. 5' The question we are askinc is, are the tyces and 6 quantities and procedures followed sufficient to warrant any 7 reduction in the basic radioisotope handling techniques a: basic training; and the second question is a more onen one: what 9l should be required in the way of clinical studies? 10 l DR. UORNWI: I dontt think the basic trainina should 11 l be any different than it is for the rest of the procedures that I2 the rest of the physicians are using materially; and as far as i I3 ' the breakdown as to training requirements, I think that which l I# Ted 17ebster outlined in his response is a good one. I CHAIRPERSON CUNNINGHAM: Ted? 6l DR. ZBSTER: Well, I an on record with the Commission '7 OMdp 3. there might be some reduction in the I0 t basic training requirenents with regard to handlin(T, and not i in connection with instrumentation, for example; not in connee 20, tion with radiation protection; but more in connection with 21 studies of radiopharmaceuticals, for examnle. 22 ;l I think the diversity of materials which the

l

'3' cardiologists will use will always be considerably less than ] 24 l that used bv the radiologists or the nuclear medicine specialists, Am4scerol Reporters, Inc., 2 ivith whatever specialty he has.

jrb26 26 i l Il t And therefore I would think that some reciu tion would i 2 be -- below 200 hours -- would be feasible and probably warranted. I think this has to be done very carefully, though; 5 because a reduction in the study of instrumentation and 6 crotection could lead to very poor quality of practice in an 7 institution. 8l And so I would go sort of carefully there. 9; With regard to the clinical trainina, I think 10 I -- what Dr. Workman referred to -- my feeling is that, again, 11 because of the narrow width of the specialty, some reduction i 12 l would be in order, beyond what is called for in the present I3 training requirements for the nuclear medicine speciality. Id l And my thought is that a cut by perhaps to close to 15 50 percent might be in order. ' i 16 ' DR. UAGNER: Without making any recommendation, I y i 17 : ! would lik~e to call attention to two points: First of all, it is my belief that the cardiological procedures are the nost comnlicated of all nuclear nedicine 20 i procedures. It is much more difficult to perforn a technically 21 ' adequate and properly interpreted cardiovascular study than it i '2 ' is to perform studies that are in other organ systems, such as 23 1 j the liver and brain. 24 ' It's an order of complexity equal to studies of 4..c n oomo. ine. I 25 the lung. That's the first point I think I would like to introduce i I

27 jrb27 i Il! for this part of the input into the discussion. 2[ The second point is that I think that the NRC should 3 do everything possible to increase the cooperation between 4 cardiologist and nuclear medicine physicians, and do everything i 5 possible to avoid anything t.t.at would result in overutilization 6 ' or separation of the cardiologists from the nuclear medicine 7! physicians. It was very interesting to me in a survey that we 8 9 carried out that I could briefly describe, althouch it will be 10 published in the March issue of the Journal of Nuclear Medicine, i i Il I we did a survey from Hopkins of all the cardiology training 12 t program directors in the United States, and all the nuclear t 13 lmedicine training program directors in the United States. And 1 l 14 ; asked them a variety of questions about nuclear cardiology. I 15 ' And the one point that I would like to interject 16 I that I think was the most interesting to me and to my colleagues, 4 i 17 ! was that 90 percent of the responses -- and there was about 36 18 percent or these 277 cardiology program directors responded, and 19 : a very high percentage of the nuclear medicine training program 20 ; directors responded -- over 90 percent of both groues said that i 21 l they believed the ideal situation for nerformance of cardio-22 ; vascular nuclear medicine procedures was as a combined effort i 23 of the cardiologists and nuclear medicine persons. 24 In my opinion, and in many -- and in the opinion of 4*ewww awomn. is ; 25 ).any of my colleagues, the technolocical components of i f

jrb28 ) I cardiovascular orocedures are best aonroached b" the nuclear 2Nmedicineperson, the person with full training in nuclear medicine, that is, I think, a minimum of a year of training. 4 Whereas the cardiolocical aspects of the program 5 are difficult to learn with the amount of training that we are 6 - accustomed to in the nuclear training programs; and I think 7 i with Dr. Holman, that we have to definitely increase the amount 8i of cardiological training in nuclear medicine programs. l 9 So with those two thoughts, that we should do every-10 lthing possible -- I think we.should recognize that cardiology I 11 and the cardiology procedures in one sense are a part of the 12 whole, but they are a part of the whole that recuires the most I3 technical and clinical e:<pertise. I# And I think that shoul ' be borne in mind. t 15 ' At least in the academic centers in the United States 16 i there is -- over 90 percent of the people think the studies 17 1 i should be combined studies. 18 ' In many institutions, such as ours, we have very ? close collaboration with cardiologists so we can draw on their 20 cardiological er:ertise, which is considerable, in proper 21 ! determination of the studies. 22 On the other hand, I don't think the cardiologists 23 ! can adequately, with their training, perform these studies 24 ' competently. Ace-recerol Hooortees, Iric. 25 - CHAIRPERSCN CU iNI:' GUAM: Dr. DeLand?

jrb29 29 i I DR. DE LA::D: I would like to reinforce what 21 Dr. Wagner said. 2 I would also like to e:gress an opinion on the 4 basic science theme. I think the basic science training when we 5 originally designed it, we felt was an absolute minimum. 6 I guess I speak for myself. However, I think what 7 we have to consider here as we look at the different portions of 8; the training, that will be the resources and the background 1 9 af the bulk of people who will be doing these procedures? 10 It will not be in a setting where we have l II l radiation health person who is well trained and so on and so forth. 12 Most of the time we'll have somebody who has i 13 ! taken the position regardless of the background that he does have t 14 i and who has to do it as a part-time job or as a volunteer in this i 15 ! particular hospital study. 16 ' Therefore, I feel that the training that we have il 17 stipulated is minimal for cardiology, future cardiology work. 18 I see your point that some of the pharnaceuticn?.s i 19 '. that will be used in cardiology and generally are in nuclear 20 : medicine; hcwever, we have to consider we do not know what 21 gadiopharmaceuticals will be forthecming in the near or distant 1 22 lfuture ; so I think it would be much cetter that the person have 23 p better grounding in general principles rather than in a narrew ,4 ;l i .ve n, just a few. um.,.i aeoormi. inc. 25 As for the physical portion of the tr.'.ining i 6

jrb30 30 I we can only speak from experience, havine trained cardiologists n a2 i who are out in private practice, to the extent that they are in i2iclinics, private offices, and practice nuclear cardiolocy in the 1 4 hespital. These we have trained for a Seriod of six nonths, S 15 hours a week, which comes to about 425 hours. 6' I think in the training course, it was not devoted 7 to nuclear cardiology, because we do about three to four procedures 3 a day. I think having a feel, say, for the lung scans is very 9 good for cardiology. 10 I asked both of these men that we did train, I asked II when they were done if they felt competent; and both of them were 12 : quite satisfied that their exposure had given then competence 13 ! to go out, t Id DR. COLLINS: Your fundamental problem here is the 15 explosion of information and technology which was written up 16 recently in an article in the Bulletin of the New York Acac'eny i I7 of Scientists under the title "The Ignorance Ennlosion", which 18 is, of course, the recriprocal. I9 ' And this is really what we're dealing with here. 20 ; I am deeply aware of the pr,blem in the development 21 of radiology over the past 20 or 25 years, and at an earlier a 1 22)P date I can recall the firstl d p under the control of l 23 h clinicians - unnamed - that had more radiation cherapy than i 24 ;my therapy machine did. Ace-Pecef ai R900fttf t, inC. 25 (Laughter.) t i i ll

jr b31 31 i !I; And we are not entirely past this, because within the f 2 past week a neurosurgeon had to be elbowed from the control switch during a myelogram. 4 It really takes the background of concern and 5 indoctrination to cope with our current problem. 6! With this, I will also remind us that during the 7l past there have been so many things that scened like a good idea 8 L at the time, and then we have had to back off. And today we 1 9i are again talking about high dose multiple patient use of 10 radioactive materials. i 11 i For this reason I think we should really return to 12 cooperation. This is no greatly different than operating the 13 lOR, the operating room, where the surgeon does not take over 5. the giving of the anesthesia. 15 Now, I am sure, if you could cross a surgeon with 16 an octopus, you micht like to do that -- 0 I7 l (Laughter.) 18 l! -- but we are limited in what can be undertaken. I And here, too, much in response to this has been the the 20 partial approaches to the solution: 21 One, that the cardiology lab should be a joint i 22 dventure with the nuclear medicine department or radiology 1 23 department, relying appropriately on a certified individual 24 or individuals who receive equionent, handling techneiues in Aa c.cer. neoomri. inc. 25 '.radiation safety. The cardiologists would select patients and

jrb32 32 I i I interpret the results. 2 The second would be that curriculum to achieve competency in utilization of the radionuclides could be developed i d b1 the approcriate body for Board certification in enrdiology, 5 and incorporated into residency or fellowship traininc programs. 6 This special competency would be recognized as a basis for 7 licensing just as is competency granted to the boards in nuclear a medicine or in diagnostic radiology for speciti competence. 9l And thirdly since we should not exclude earnest, 10 competent individuals in circumstances where the individual 11 cardiologists plan to use radionuclides in the oractice, uould be 12 familiar with the general requirements for skill and training, 1 I3 ; he could and should present documentation of personal preparation i Idispecifically as to use of radionuclides, on a case by case 15 review of his application for licensure. 16 ' This should still be a possibility. il 17 : i This however might well be remote from a medical 1 18 lcenter, and in the medical center it seems to me to develop an octopus. 20 CHAIRPERSON CUNNINGHAM: Thank you very much, 2I Dr. Collins. I think your summarization of the cotions is I '2 ! very helpful to us, i 23 6 l As I see this developino we have several choices : cardiolocists working in cooperation with somebody from the Ace-recerad Reportert i nc, 25 nuclear medicine laboratory; or the cardolocist on his cwn with i 1

jrb33 33 i i l i some specialized training; and simoly review on a case by case 2 I' basis -- a procedure basis I cuess would be better to say. 3 I wonder -- this has been discussed somewhat -- I 4, wonder if Dr. Holman would like to comment on the ccmments of 5 the advisory committee? 6' Dr. Griem? 7; DR. GRIEM: Recentiv the FDA has made certain t l 8: recommendations which have been announced in the Federal Register i 9 concerning the use of radioactive materials, and set forth certain 10 ; guidelines concerning dose let.els which may be administered, t II I The principal concern of the FDA is the radiation 12 exposure to the patient. Gne might put it in a cost-benefit 13 basis, as the cost of the radiation and the benefit of the 14 tprocedure in the diagnostic information derived. 1 15 l There are a number of techniques available for \\ 16 Amacing disease in the heart, these include anciogra9:.v, il 17 lisotopes, ultrasound, and CAT scanning. Now all of these involve l 18 ' radiation doses. 19 ' And I think that one needs to work with both these \\ 20 ;in order to minimize the radiation dose to the patient, particu-i 21 arly patients with a long life span; so that in nuclear 22 bardiology, the person should be licensed to do this who has p 23 l1 Adequate training in radiation safety instrumentation and 24 ' nuclear medicine imaging to ass'me that the eatient's radiation Ace coce,at Reocriers, Inc. 25 dose is kept to a minimum, and the necessarv information obtained l

34 jrb34 i I' from the diagnostic procedures; and the persons licensed by the I 2 ' NRC have adequate knowledge concernino the pharanacolecic f ascects of the drug administered, and the licensee have adecuate 4 knowledge concerning the instrumentation, so as to minimize the 5 patient's ex osure to snecific diagnostic procecures. 6: CHAIRPERSON CUMMINGHA'i: Thank you. I: Dr. Holman? 0 DR. HOLMAN: I think in my opinion the most important 91

i. 153ue raised bv the comnittee is that we said it is crucially 10 limportant that if possible cardiac nuclear nedicine be ll i administered as a collaborative venture beteeen the nuclear 12 !

i cardiologist and the nuclear medicine person. 13 I CHAIRPERSON CUNNINGHAM: Thank you very much. i I 14 ' I think that's very constructive. 15 l Do you want to summarize? l 16 DR. WADE: If I jotted down the notes I have here l 17 1 ! correctly, I guess that first of all most people seem to think la . it should be a cooperative venture. In those cases, however, I where a cardioloaist wants to be authorized to use it by 20l himself, with one exception -- that exception bei My Dr. Webster -- 21 11I think the general feeling is that the basic training recuire- '2 ' ments should be the same, with perhaps some reduction in the 23 I

clinical training.

There is not agreement there thouch. 24 ' CHAIRPERSON CUNNINGHAM: Dr. Quinn? Am emma Recrwn, lm. 25, DR. QUINN: I don't think it's inappropriate J

jrb35 35 I i l' to bring up a famous saying of H. L. '4encken, The Baltimore Sun, 2 "To every complex problen there is a simple solution, and it's always wrong." 4: (Laughter.) 5 So my sympathy is e:: pressed with that of Dr. Webster. 6 I think the basic training requirements should remain at the 7 i minimum, and that the clinical training cmabe modified as thought 8: appropriate. l 9 i DR. COLLIMS: In an attempt to reconcile these 10 two apparent differences of opinion, I have noted that the i 11 'loutline that we have before us is -- does not detail the contenti i 12 ; and without such a detailing there's no real basis for affirming ' i I3 l that round of numbers of hours is indeed appropriate. I# l It's quite possible the number of hours could be 15, reduced by sharpening the objectives and intensifying t'c.e i 16 ' instruction. It depends on who's teachine what. So it isn't I7 l actually the hours that we're disagreeing with; it is what is i 18 the content? In the overall, if the cardiologist may be safe 20 with half the training, then should we not vonder if the person 21 l training in nuclear medicine is getting twice as much as he '2 'd needs? a 1 23 ' Really, this is not an effective discussion unless 24 Lwe know the details of procram that we are fccusinc on, the Ac.-.o.,e 9.oc.nm. ine. : 25 '{ content, that is. f

jrb36 36 I! CHAIRPERSON CUNNINGHR".: Chat's a good coint. 2.* What I propose we do is review this record with sone i 3 of the suggestions that have gone round this room, and try to i 4 come up with some very specific recommendations. ?!aybe they could i 5 be recirculated for further ccmments. 6' DR. WAGNER: I think I emphasize that I think 7 ! Dr. Collins' three options for all could be available, not that 1 0 one was to be picked by the NRC -- if I understood correctly, 9: Dr. Collins recommended three possible pathways, any one of i 10 t which could be taken. i Il i DR. COLLINS: Absolutely. 12 ; j DR. NAGNER: I think the other point that, since the 13 field is in its adolescence at least, if not i:. its infancy, la I i I think that as nuch flexibility as possible should be kept in the regulations so that one can have special cases that would 16 ijjbebrought to the NRC where a person believes that he or she 1 17 ' i is qualified to do the studies and won't fit into one of these 13 three options, I think that waiver should be available. ~* I would not at this point free:e it into one option. l 20 ! I think it might be an oversimplification, foilowing what 1 21 ' Jim Quinn is saying, I singly say we don't need to change the 1 22 ] requirements at all. i '3 'i I think if the NRC cane out and said there 's no 24 difference, it's exactly the same; I think -- and them are no 4..,wn.i n wonni. e x. 25 !!qother options, I think that that might be the wrong thinc to do. a o !I

jrb37 37 I I: So I would try to build as much flexibilitr into the i 2 [ regulations as possible for the present time, although you might 3 have to consider a fairly large nunber of them initially on a 4 case by case basis. 5 But I think, again, to reemphasi:e, the studies -- 6 I think it would make a big difference where the person showed 7 efforts to collaborate, the cardiologist collaborating with the i 8j nuclear medicine physician,.and vice versa; there are many, many 9{ people now who are licensed to do nuclear medicine procedures 10 that are not qualified to do nuclear cardiology procedures. II l So that I think the committee -- it behooves the I2 {I conclitee to continually look at revisions of recuirenents for 13 the people that are already licensed under prior NRC I4 regulations, to make sure that they stay current, when there 15 ; is the great increase in the complexity and application of these i 16 studies. 1 I7 CHAIRPERSON CUNNINGHAft: Your comments are well taken. I 18 l We have two competing objectives in structuring our i i 39, regulatory framework; one that you mentioned, that we recognize 'o l i 20 !it is an evolving field, and there are a number of ways that the 21 l patients may be damaged with the procedures; and that a narrow -- 22 haking the options, or having a narrow range of ootions, micht 23 hot be good at this time. 24 4c....e m n uo,ms iac.. On the other hand, we have to balance that against 25 ihe -- just the administrative load placed on cardiologists and

jrb38 38 1 nuclear nodicine practitioners to just ecme in every tine they 2 0 want to do something. 3 So it's the objective of staff, of the advisory 4 committee to try to balance these two obiectives. 5 DR. WEBSTER: I assune you don't ware to be 6 ' categorized as a person who doesn't want nuclear cardiologists 7 to be trained at all? 8< (Laughter.) 9; I do know some like that. And sort of gradually 10 edged sidewise into the field of nuclear medicine with very 11 ! little training, and I am very distressed about that. 12 I feel that even if we insist on, say, 50 percent 13 ! as a bare minimum -- and I think it could go higher than that -- 14 but only 50 percent of what the requirement is for the nuclear 15 medicine specialist, this is going to be very difficult for the 16 cardiologist to meet without considerable restructuring of his k 17 i training program. 18 ' So this 50 nercent is oretty tough for them, and i 19 lI think on view of what they are really doing in nuclear medicine 20 ' it might end up somewhere around that level; maybe 60 percent. 21 But I don' t think it has to be 100 percent. 22 CHAIRPERSON CUMNINGHAM: Yes, sir? l 23 ;! DR. C'1ITH: I am Dr. Edward Smith. 24 I would like to nake a specific proposal on a training we.eer, n.conm. inc. 25 program, if this would be appropriate? I 1fi

jrb39 39 I This is for the group to consider, which apcroaches ,j ' " this general guideline : of a 90 hcur didactic concentrated program put on by qualifi2d individual in " clear medicine; plus a very well tailored and well scecified clinical encerience 5 procram, just for nuclear cardiology, and just for the :BA 6 approved procedures, as well as an ongoinc consulting program 7

to ensure that the cardiologists, who are not nuclear physicians, 8

have the necessary backup as far as radiation safety, quality 9, control and clinical technique. 10 And since I spon' wi th Mr. Wade through the appropriate i 11

channel to take to present this to the Commission --

I2 ; CHAIRPERSCN CUNNINGHAM: Well, I think, Dr. Smith, I3 if you would like you can just give it to our doctor there, and I# we will just enter it into the record. 15 DR. S:!ITH : Yes, and would it be appropriate to comment 16 : on this a little, if I may? The logic behind this? I I7 I spoke with many cardiologists, and one of the IO ;bigcest pecblems they have is they have the expertise from the ~* cardiolocy point of view, and are willing to learn what they 20 need to learn on the nuclear medicine side; but, unfortunately,

• 1 ! speaking with many nuclear physicians, also, thev are not 22 willing to put forth the same ef fort at cetting to know what

'3 they really need to know in the nuclear cardiology. '4 Am recerse Reoorters. Inc., have the desire to ao out and get the The" don't 'S ] fornal training to do the cardiologist's part; whereas the i

irb40 40 I converse is true: the cardiologist is willing to spend the time 2, tc get the training he needs. And it's a lot safer -- I personally would rather 4 have a cardiologist do a nuclear cardiolocist procedure if he 5 is willing to admit the nuclear experience; and I don't know if 6 ' I would have the same confidence for a nuclear physician just 7' doing nuclear cardiology. Because he can kill me. And I feel 3 a lot more comfortable with a guy who knows how to save me if he 9' gets me in that position. 10 I think it's very important that we give these oeople i II i the opportunity to get the formal training at this point, 12 ' and let it be approved, sponsored, by whatever groups wants to I3 lsponsor it; but as long as it's a rigorous training, where they Id know the fundamentals of nuclear physics and so on, ! think ue 15 will be a lot better off than letting this sort of thing sort of 16 drift into no where, and say, no, they cannot got the traininc. I7 CHAIRPERSOU CUNNINGHA1: Well, I don't think I3 anybody is saying no, they can' t get the tralaina, Dr. Smith; ~e 19',but we appreciate your comments, and we will count as part of the l 20 ! record your proposal. 21 DR. SMITH: Thank you. 22:l (The full document follows:) 1 23 P 24 Aco rederat Reportm, f x. 25 : 1 N

.[ )I,p - / EDWARD M. SMITH, Sc.D. NUCLEAR MEDICAL SCIENTIST A PROPOSliD TRAINING PROGRAM FOR CARDI 01.0 GIST TO B F. LICENSI0 TO l'ERIMRM NUCl.I' Ak C A RD ! O! AY STU D 11.S This is a proposal for providing the necessary didact ic experience, clinical experience and on-going consultation service in the areas of radiation safety, quality control, clinical technique and basic science to cardiologists who desire to be licensed to perform nuclear cardiol-ogy studies. This is a three part program consisting of:

1. A twelve day formal training program on the basic and applied sciences of nuclear medicine, and radiation safety and quality assurance as they relate to nucie'ar cardiology.

This program consists of 90 contact hours. The detailed lecture plan is given in Appendix 1.

2. Clinical experience in the operation of a nuclear med-icine labcratory and interpretation and reporting nu-clear carclology studies.

The details of the program are given in Appendix 2.

3. The retaining of a nuclear medical scientist as a con-sultant for a two year period to provide continuing education and insure that the laboratory is practicing good nuclear cardiology from a scientific and technical standpoint.

The details of this program are given in Appendix 3. It is proposed that af ter a cardiologist can show evidence of satis-factorily completing Parts One and Two above and has retained a nu-clear medical scientist for a two-year consulting program as out-lined in Part 3, the cardiologist be granted a limited radioactive materials license to be used in the practice of nuclear cardiology. The cardiologist would be licensed to use any FDA approved radionu-clide, radionuclide generator or " cold" kit for the preparation of radiopharmaceuticals which can be used for the evaluation of cardio-vascular circulation, myocardial perfusion, infarcts and hemodyna-mic function. 12~13/73 P o. eon 123,WaHand. Tn. 37686,615-364-539 o r 9 31 - 29 31

1 of 4 EDWARO M. SMITH. Sc.D. NUCLEAR MEDICAL SCIENTIST APPENDIX 1 - TWELVE DAY FORMAL TRAINING PROGRAM (90 CONTACT HOURS) A. INTRODUCTION (3 hours)

1. What is nuclear medicine and how does cardiology and nuclear medicine interrelate

2. Quality assurance program in nuclear medicine

3. Basic laboratory design B. PHYSICS OF NUCLEAR MEDICINE (24 hours)

1. Review of basic math

2. Structure of the atom

3. Structure of the nucleus

4. Origin and characteristics of radiation

5. Principles of radioactive decay

6. Mathematics of radioactive decay

7. Statistics of measuring radioactivity 8.

Interaction of charged particles with matter 9. Interaction of photons with matter and mathematics of shielding calculations

10. Review for Sections A and 3

11. Examination for Sections A and B C. RADIATION DETECTION INSTRUMENTATION (10 hours)

1. Physics of ionization chambers and G.M.

counters

2. Applications of gaseous detectors in radiation monitoring and calibration of radioactivity 3.

Interaction of photons in ai:, water, NaI(Tl) and lead 4 Basic instrumentation compc. Mats and their function in gamma-ray spectroscopy

5. Evaluation of counting conditions and the resulting gamma-ray spectra 12/13/73 P o. Box 1:S/ Walland, Tn. 37886,615-984 2599 or 984-2931

2 of 4 EDWARD M. SMITH. Sc.D. NUCLEAR MEDICAL SCIENTIST APPENDIX 1 (Continued) D. RADIATION PROTECTION AND RADIATION SAFETY REGULATIONS (6 hours)

1. Sources of radiation exposure in the nuclear medicine laboratory

2. Time, distance and shielding-the tools to minimize rad-iation exposure

3. Personnel exposure

4. Radiation monitoring

5. Radioactive waste disposal

6. Rules for working with radioactive materials

7. Area and personnel decontamination

8. Record keeping E. RADIATION BIOLOGY AND ABSORBED DOSE CONSIDERATIONS (6 hours)

1. Stages in the development of biological damage from ion-i ing radiation

2. Factors affecting biological damage

3. Acute effects of radiation 4.

Long-term effects of radiation

5. Effec *. of radiation on the fetus

6. The radiosensitivity of tissues

7. Methods of calculating radiation absorbed dose

8. Radiation dose resulting from nuclear cardiology studies

9. Review for Sections C, D and E

10. Examination for Sectiot.s C, D and E 12/13/78 P o. Boi 12Se Wadand. Tn. 37886,615 964 599 o r 9 8 4 - 29 31

3 of 4 EDWARD M. SMITH. Sc.D. NUCLEAR MEDICAL SCIENTIST F. IMAGING SYSTEMS INCLUDING COMPUTERS.\\ND THE NECESSARY QUALITY CONTROL (24 nours)

1. Principles of operation of the Anger camera

2. Principles of operation of the multicrystal camera

3. Collimation

4. Laboratory demonstration on the use of an imaging system

5. Specifications for imaging systems

6. Display devices and media

7. Quality control of imaging systems

8. Fundamentals of computer concepts and terminology

9. Computer applications in nuclear cardiology

10. Fundamentals and applications of longitudinal and transaxial tomography to nuclear cardiology

11. Review for Section F

12. Examination for Section F G. RADI0 PHARMACEUTICALS AND RELATED RADIATION SAFETY AND QUALITY CONTROL CONSIDERATIONS (12 hours)

1. Production of radionuclides and radionuclide generators

2. Pharmacology of the radiopharmaceuticals used in nuclear cardiology

a. Tc-99m as pertechnerate

b. Tc-99m labeled PYP

c. Tc-99m labeled DTPA

d. Tc-99m labeled in-vivo red blood cells

e. T1-201

f. Other potential radiopharmaceuticals 12/13/73 P. o. Bos 128.Waitand. Tn. 37886< 615-984-2599 o r 9 3 4 - 2 9 31

4 oL 4 EDWARD M. SMITH, Sc.D. NUCLEAR MEDICAL SCIENTIST 3. Proper ordering, receiving, disposal and inventory con-trol of radioactive material 4 Method of eluting radionuclide generator and preparation of kits

5. Radiation safety considerations in the radiopharmacy

6. Demonstration of the preparation of radiopharmaceutical kits

7. Assay, quality control and record keeping required for radiopharmaceuticals H. PRACTICAL CONSIDERATIONS IN PERFORMING NUCLEAR CARDIOLOGY STUDIES (5 hours)

1. Proper sequence and timing of imaging procedures including the selection of the right radiopharmaceutical

2. Patient positioning and injection techniques

3. Proper selection of collimators, total counts and imaging time

4. Other considerations

5. Review for Sections G and H

6. Examination for Sections G and H 12/13/73 P o. Sc= 128'Wadano. in. 37886,615-984-2599 o r 9 3 4 - 2 9 31

EDWARD M. SMITH. Sc.D. NUCLEAR MEDICAL SCIENTIST APPENDIX 2 - CLINICAL EXPERIENCE The cardiologist under the appropriate supervision would: A. For 5 nuclear cardiology studies prepare the radiopharmaceu-tical, perform the necessary assay and quality control pro-cedures and maintain the records, B. For 5 nuclear cardiology studies prepare the patient fo r imaging and perform the injection, C. For 5 nuclear cardiology studies perform the actual imaging, D. For 5 nuclear cardiology studies process the data on a data processing system, E. Interpret the results and prepare the reports for: 1. 10 cardiovascular circulation studies,

2. 25 T1-201 perfusion studies (stress and redistribution) i

3. 10 infarct imaging studies, and 4

50 hemodynamic function studies, F. Perform the quality control on the imaging system and record and interpret the quality control data, and G. Perform a radiation survey of the laboratory and record the data. 12/13/73 P o. Sca 1281Wadand. Tn. 37886,615 96 & 2599 or 984-2931

EDWARD M. SMITH, Sc.D. NUCLEAR MEDICAL SCIENTIST APPENDIX 3 - TWO-YEAR NUCLEAR Ml: DICAL SCIENCI! CONSUI. TING PROGRAM The inlividual providing the consultation shall be Boarded or Board-Eligible by the American Board o f Science in Nuclear Medicine. The consulting program would consist of: A. The consultant and the cardiologist would:

1. Design the laboratory area and specify the equipment,

2. Prepare the radioactive materials license,

3. Prepare the radiation safety manual,

4. Prepare the quality control manual, and

5. Prepare the procedures manual.

B. The consultant will provide 2 days of training on the operation of the laboratory and equipment after the imaging equipment is operational. C. The consultant will provide on-site visits at months 1,2,4,6,9, 12,15,18 and 21 after the initial 2 day visit. During these visits the consultant will review the operation of the labora-tory and make the necessary measurements with respect to rad-iation safety, quality ccatrol, procedural technique and pro-vide additional training as required. D. The consultant will be available for telephone consultation for the 2 year period. 12/13/78 P. o. Son O,waitand. in. 37866,615-9tu-2599 o r 9 8 4 - 2 9 31

jrb41 41 i l I' CHAIRPERSON CUNNINGHAM: I don't think we need further i 2 comments on this subject -- are there any? 3 (No response.) 4 Ne have a rather full agenda. 5-DR. COLLINS: There was some connent some place in 6 ' the papers that commercial companies will provide necessary 7 training. It was in someone's letter. O DR. MADE: In what was sent to you? 9 j DR. COLLINS: Yes. 10 DR. WADE: We have -- well, let me back up a monent. Il i The three alternatives, the three possible routes, 12 lwe have no intention of limiting any routes now. We are really 13 focusing on the one alternative where the cardiologist wants 14 to get the training. 15 And our question is: Basically, what tvpe of training 16 i i should that be? I 17 ' l Now, one of the things that precipitated this was 18 l i the indirect approaches by some of the companies who wanted -- 19 ! the commercial firms who wanted to establish training nrograms; 20 land we just deferred any answers. 61 1 DR. COLLINS: I thought it not inappropriate perhaps ,", i,!jto comment that as this is or might well be a supported activity, l 23 l that we should be cautious about extending the rather recent 24 land rather wide press comment en some commercial lay Am+eceval Aeoorters, Inc. 25 perscnnel who helped in the OR about cutting prothesis in a hic.

jrb42 42 I :l I think we should probably not turn to commercial conpanies 4, 0 for our training in clinical fields. d 1 CHAIRPERSON C WNINGHA't: Thank you very much, 4 I Dr. Collins. The word of caution is well taken. i 5 Are there any other comments on this subject? 6-(:k) response.) 7 If not, perhaps we can move on to the ne:ct one. 8' DR. WADE: The next subject has to do with performing I 9i

in-vitro diagnostic studies.

10 ' For those of you who aren' t f amiliar with how our 11 ' ! advisory committee uorks, we conduct a major portion of our 12 'j business by mail, because we have constant questions and we can't 13 i 1 get them all -- we can't hold neetings often enc'.ch to cover I i 14 ; eve ry thing. 15 ' One -- this one next question on the agenda was one 1 16 < that we asked the advice of the committee, and the" were not

I 17 : in acreement in the advice that they gave to us; and so we 18 decided to raise the issue here again where it could be discussed.

19 That has to do with whether or not the individual 20 listed as the authorized user on the license should be a 21 physician. '2 The question arosa not because we questioned the '3 'Icompetency of the individual that handled radioactive 7.aterial, 24 but the question was raised because of the fact that these 4c....o . neconert inc. 'S : studies are used in making -- the results of these tests are used

l l

irb43 43 l I [ in making diagnoses and in the in-vivo procedures one of the a 12 ij functions that's supcosed to be fulfilled by the physician 3 on the d' ruc as authorized user, is the interpretation of results; u 4 even though he himself may not and probably not knows too much 5 in handlin' of radioactive material. 6: On the other hand, we are aware that both the 7 - Social Security Administrati6n through the Medicare Program 8; and I guess the Center for Disease Control have regulations, i 9I guidelines governing clinical laboratories; and they specify that 10 t the laboratory directors need be qualified, but not necessarily I 11 l a physician. I guess this is part of the Clincial Laboratory I 12 Improvement Act. 13 We should in our policy statement -- that we published 14 ' for comment, and we'll hear more about that later -- we stated 15 ' that essentially we would stay out of those areas that are i 16 regulated by other agencies, where there is no threat to health 1 17 ! and safety. IO So those are the two sides of the issue. 19 i i Do we have comments? 20 CHAIRPERSON CUNNINGHAM: Yes. 2I My outline here indicates we have two ceople who wish l to comment on this subject, >T. Edward James, representing 23 b the Clinical Radioassay Society, and Dr. Alan Broughton, repre-24 senting the American Association for Clinical Chenistry. ac.-,.a n.co,ms inc. ; 25 I Is :tr. James here? t 'i

44 jrb44 i 1 STATEMENT OF DR. ALBERT E.

EERNER, Ph.D.,

Director, i

2 HERNER ANALYTICS, INC., ON 3EEALF Or TIII CLINICAL 2 RADICASSAY SOCIETY: 4 - DR. HERNER: I am Dr. Herner, and we are representinc 5 the Clinical Radioassay Society. 'I 6 I laaL with me a letter from the President of the Society, 7! Dr. John Langan. Nould you like me tc read this? Or shall I 8 submit this to the Committee? It's fairly short. 9 CHAIRPERSON CUNNINGHAM: Yes, please do read it; we 10 : would also like a copy of it: II i DR. HERNER: The Executive Board of the Clinical l 12 Radioassay Society has authori:ed me to write the following I3 statement and request that it be read into the record of the i I4 Medical Advisory Committee of the Nuclear Regulatory Commission. i i 15 i The Clinical Radioassay Society is a nationwide 16 {1 organization established to maintain and improve the i, 17l standards of performance of radicassay; to improve education, and i 18 to advance the practice of radioassay as applied to physiology l9 l and pathology in the diagnosis, treatment and prevention of 1 20 ldisease. 21 The individual members of the Board are all full-time 1 2' '; practitioners in the field of radioassay. They mostly 23 hold or have held university professorial level teaching 24 'l 4c....c.,e neoorms, ine. appointme nt s ; all teach within this and other professional and 'Sj;medicalsocieties, such as the Society of Nuclear Medicine, I

jrb45 45 lllThe American Association of Clinical Cherists, the American 2!!SocietyofClinicalPathologists, et cetera, in which organiza-tions they current hold or have in the cast held senior official 4: positions. 5 We, the Board of Directors of the Clinical Radioassay 6! Society, are strongly opposed to the recommendation"that the 7I use of byproduct material for diagnostic studies be performed i 8 by or under the supervision of a physician." 9 Very few physicians are trained in the procurement, 10 ! handlino and storage of isotopes. Very few physicians know the II I physical and chemical characteristics of these isotopes such i 12 ' that they could direct these crocedures. Very feu physicians 13 know how to treat a spillage or leakage of isotopes. Id These statements are supported by the many years we I IS ' have jointly spent teaching these procedures to student bodies, i 16 which included physicians. Rarely are physicians in the work I7 l area where radioimmunoassavs are performed. Thus rarely would i 18 l they be available to combat a hazardous situation. l 19 The supervision of isotopes used in in vitro testing 20 in a laboratory should be performed by scientific and technical 21 personnel who work full time in these areas, and who have been il 22 deducated, trained and are e::cerienced in the use of these F 23 ll isotooes. 24 The imolication that 4m-rece amonm. w. ; laboratorv level personnel are 25 recuired to interpret the results of in vitro tests is of d

jrb46 46 t i I dubious validity. Laboratory personnel submit the results i 2 l of their analyses to the physicians who have requested the analyses in the first place. i 4 These physicians are treating the patient and are in 5: a position to interpret the test results in relation to that 6: particular patient. The result of an analysis in which an isotope 7l is used would be interpreted in exactly the same way as a i I 8' result of an analysis for the same compound using a nonisotonic 9 technique. 10 An example would be folic acid determination I II l obtained by isotopic or by microbiologicaltechniques. 12 The patie m's hematologist is best equipped to I3 int erpret the results, not a pathologist, nuclear medicine Id physician or clinical chemist, who may have supervised the analysis, 15 ! but who is not treating the patient. 16 ! The days are over when the physician at the bedside ,l i I7 had to perform the blood tests he required. Laboratorv medicine 18 j is so extensive and the technology so sophisticated that i 19 I no one person could possibly perform all forms of laboratory i

• 0 i i testing and treat all types of patholocical conditions of the 21 hpatient, h

22 h The day of intense specialization has arrived. l 23 hBiomedical scientists devote their whole professional lives 24 ;to perfecting small areas of speciali:ed diagnostic crocedures. we.com a.oorteri. inc. 25 '(Radioimmunoassay is an immunochemical technique. It should be 'i i

jrb47 47 i i i Il supertised by snacialists, whether they be physicians or 2, s cientis ts, they should be highly ~ trained and dedicated to the analytical procedures of the clinical laboratory, and in 4 ;particular to inmunochemistry. 5 My statements on this matter are supported by and 6 even described by the existina Clinical Laboratory Imorovenent 7 Act CLIA. The requirements for laboratory directors a re very 8 clearly prescribed by CLIA and administered by the Center for 9 j Disease Control, Medicare and the Departments of Health of the 10 individual States of the Union. I Il i These regulations do not require that a laboratory 12 ldirector be a physician. Before the NRC ill-advisably denies i I3 l the current laboratory licensing regulations of other Federal 14 and State agencies, at the advice of its own small group of i IS seven physicians and a physicist, I suggest it consult these 16 other agencies. l I7 l The laws regulating laboratories have taken years to i 18 i develop. A revised Clinical Laboratorv Improvement Act has 19 been several years in preparation and has beelheatedly 20 > debated in Congress for the last two years. A precipitous 21 h decision by the NRC at this particular mcment 'tithout full and 22]l i onen investication and debate would seem ill-advised. 1 23 l And this is siened by John Langan, Ph.D., who is 24 President of the Clinical Radioassay Society. And I will submit Aer.e.r.i n.oormt inc. 25 lthis letter. i (The full document follous:)

MNchos Institute g,, re 7 HERNER ANALYTICS, INC. Albert E. Herner, Ph.D., Director December 12, 1978 accxvn fz. E E III E Y Y E uta m

Dear Dr. Wade:

The Executive Board of the Clinical Radioassay Society has authorized me to write the following statement and request that it be read into the record of the Medical Advisory Committee of the Nuclear Regulatory Comission. The Clinical Radioassay Society is a nationwide organization established to maintain and improve the standards of perfomance of radioassay; to improve education, and to advance the practice of radioassay as applied to physiology and pathology in the diagnosis, treatment and prevention of disease. The individual members of the Board are all full-time practitioners in the field of radioassay. They mostly hold, or have held, university pro-fessorial level teaching appointments; all teach within this and other professional and medical societies, such as The Society of Nuclear Medicine, The American Association of Clinical Chemists, The American Society of Clinical Pathologists, etc., in which organizations they currently hold, or have in the past, held senior cfficial positions. We, the Board of Directors of the Clinical Radioassay Society, are strongly opposed to the recommendation "that the use of byproduct material for diagnostic studies be perfomed by or under the supervision of a physician." Very few physicians are trained in the procurement, handling and storage of isotopes. Very few physicians know the physical and chemical characteristics of isotopes such that they could direct these procedures. Very few physicians know how to treat a spillage or leakage of isotopes. These statements are supported by the many years we have jointly spent teaching these procedures to student bodies which included physicians. Rarely are physicians in the work area where radioimuncassays are performed. Thus rarely would they be available to combat a hazardous situation. The supervision of isotopes used in in-vitro testing in a laboratory should be perfomed by scientific and technical personnel who work full-time in these areas, and who have been educated, trained and are experienced in the use of these isotopes. The implication that laboratory led personnel are required to interpret the results of in-vitro tests i; of dubious validity. Laboratory personnel submit the results of their analyses to the physicians who have requested the analyses. These physicians are treating the patient and are in a position to interpret the test results in relation to that particular patient. The result of an analysis in which an isotope is used would be interpreted in exactly the same way as a result of an analysis for the same comoound using a non-isotopic technique. An example would be a folic acid deteminaticn obtained P.O. Scx 624 Pnneeton, New Jersey 0854o Phene (201) 874-3300

""" Nichos Institute obreast by isotopic or by microbiological techniques. The patient's hematologist is best equipped to interpret the results, not a cathologist, nuclear medicine physician or clinical chemist, who may have supervised the analysis, but who is not treating the patient. The days are over when the physician at the bedside had to perform the blood tests he required. Laboratory medicine is so extensive and the technology so sophisticated that no one person could possibly perform all foms of laboratory testing and treat all tyces of pathological conditions of the patient. The day of intense specialization has arrived. Biomedical scientists devote their whole professional lives to perfecting small areas of specialized diagnostic procedures. Radio-immunoassay is an imunochemical technique. It should be supervised by specialists, whether they be physicians or scientists, they should be highly trained and dedicated to the analytical procedures of the clinical laboratory a d in particular to imunochemistry. My statements on this matter are supported by and even described by the existing Clinical Laboratory Improvement Act CLIA. The requirements for laboratory directors are very clearly prescribed by CLIA and administered by The Center for Disease Control, Medicare and the Departments of Health of individual States of the Union. These regulations do not require that a laboratory director be a physician. Before the NRC ill-advisably denies the current laboratory licensing regulations of other Federal and State agencies, at the advise of its own small grouo of seven physicians and a physicist I suggest it consult these other agencies. The laws regulating laboratories have taken years to develop. A revised Clinical Laboratory Improvement Act has been several years in preparation and has been heatedly debated in Congress for the last two years. A precipitous dec'sion by the NRC at this particular moment without full and open invesHpcion and debate would seem ill-advised. Sincergl,y ycurs, f .h m Jh Langan, Ph 9. President Clinical Radioassay Society

jrb48 48 I I CHAInPERSON CUNNINGHAM: Thank you very much, 2 Doctor. 3, We also have Cr. Broughton. t 4 STATEMENT OF ALAN BROUGHTON, ON BEHALF OF THE 5 AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY: 0 DR. BROUGHTON: My name is Alan Brouchton, I an a 7 board-certified pathologist and clinical professor of pathology i 8 for the University of Texas. I am also Chairman of the 9 Radioassay Subcommittee of the American Association for Clinical 10 ! l Chemistry, whom I represent today. 11 ' This association is a national professional 12 lorganization representing approximately 4,700 nenbers enoaged in I3 the delivery of clinical laboratory services. Many are well-I# established and recognized experts in the use of radioisotopes 15 in the clinical laboratory. 16 l Indeed one of our members was?. involved in the develop-l 17 ' I ment of radioimmunoassay in 1962 -- '59 to '62. 18 The Nuclear Regulatory Comnission has developed 19 i licensing procedures ehich recuire that in vitro diagnostic 20

procedures, involving the use of radioisotopes be performed under 21 the direction of a physician.

These procedures are not consistent '2 with well established practice. 1 23 i; These procedures, which serve as a condition for 24 ! issuance of a license to use these reacents, discriminate unfairiv A<:n receral Reporters, tric. ~ ~ 25 :lagainst competent scientists, who, were they performing exactly i

jrb49 49 1ithe same crocedures on protein-based material fron other sources, 2,. such an enzymes or bacteria, would not be subject to these 3 rules. 4, What, we ask, is so different with this chemical 5' methodology that it requires the direction of a physician -- 6 ' one who may well know absolutely nothing about the chemical 7l principles of quality control of the techniques involved. i 8! The requlations of medical laboratory practice, 1 9l including appropriate personnel standards, have been established i 10 ' for all clinical laboratory disciplines, including radiobicassay. 11 These are cortained in the CFR Title 20, Subpart M, and Title 42 l i 12 l Part 74. 13 Very specific standards for personnel have been developed 14 in these areas. These standards provide for the direction of a 15 ! clinical laboratory by appropriately qualified scientists, both l 16 physician and nonphysician, who must full rather extensive il!- 17 l requirements beyond their professional degree to qualify as a 18 llaboratory director. 19 ; Ne can see no advantage to the public, the patient, i i 20 ; the analyst, in this licensing procedure. Again, the only l 21 ! effect in many areas would be to raise the price of an in vitro 22 radioassay procedure to the patient because of the introduction 23 l! of another unnecessary layer of supervision, which nay well not i 24~ exist in fact. A=-r.e m n.oo,mi. ine. l 25 The American Association for Clinical Chenistry i t

jrb50 50 i I{ strongly protests this unfortunate procedure. We believe that 2 the Nuclear Regulatory Commission has been ill-advised. If this crocedure is to be followed, very competent scientists 4 who have for years denenstrated that conpetence in the use of 5 radioisotopes in bioassay would be denied a license to use 6 'I them, 7 We ask again, why do these procedures seccre so 8 ! different when performed for diagnostic purposes? I 9 Ne are forced to believe that the logic behind this i 10 advice has little to do with the health and welfare of the i II patient -- rather, it has to do with the protection of the 12 vested interests of a very special-interest grouo. 13 f Thank you. i I4 (The full document follows:) 15 16 i il i 17 ! 18 f i 19 l l 20 21, 22 23 '1 Am-eene nworms. ix. 25 : I

h h: u w h.,, / . ~%. lo%df1 AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY k,yf 1775 K Street, N.W. Washington. O C. 20006 e Phone 202/833-3590 202/8574 717 December 14, 1978 File: 1112 Mr. Cunningham c/o NUCLEAR REGULATORY COMMISSION Washington, DC 20555

SUBJECT:

REGULATORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES [FR Docket 78-308171

Dear Mr. Cunningham:

The American Association for Clinical Chemistry (AACC) is a national professional organi.tation repre-senting approximately 4,700 members engaged in the delivery of clinical laboratory services. Many are well-established and recognized experts in the us of - radioisotopes in the clinical laboratory. Tht Nuclaar Regulatory Commission has developed licensing procedures which require that in-vitro diagnostic procedures, involving the use of radioisotopes be performed under the direction of a physician. These procedures are not consistent with well-established practice. These procedures,t.hich serve as a condition for issuance of a license to use these reagents, discriminate unfairly against competent scientists, who, were they performing exactly the same procedures on protein-based material from other sources, would not be subject to these rules.

. What, we ask, is so different with this chemical methodology that it requires the direction of a physician -- one who may well know absolutely nothing about the chemical principles or quality control of the techniques involved. Regulations of medical laboratory practice,' including appropriate personnel standards, have been established for all clinical laboratory disciplines including radio-bioassay. These are contained in the CFR Title 20, Subpart M, and Title 42 Part 74. Very specific standards for personnel have been developad in these areas. These standards provide for the direction of a clinical laboratory by appropriately qualified scientists, both physician and non-physician, who must fulfill rather extensive require-ments beyond their professional degree to qualify as a laboratory director. We can see no advantage to the patient, the analyst, or the public in this licensing procedure. Again, the only effect in many areas would be to raise the price of an in-vitro radioassay procedure to the patient because of the introduction of another unnecessary layer of supervision, which may very well not exist in fact. The American Association for Clinical Chemistry strongly protests this. unfortunate procedure. We believe that the Nuclear Regulatory Commission has been egregiously ill-advised. If this procedure is to be followed, very competent scientists who have for years demonstrated that competence in the use of radioisotopes in bioassay would be denied a license to use them. We ask again, why do these procedures become so different when performed for diagnostic purposes? We are forced to believe that the logic behind this advice has little to do with the health and welfare of the patient -- rather it has to do with the protection of the vested interests of a very special-interest group. Respectfully submitted, William J. Campb 1, Ph.D. Executive Director AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY 1725 K Street, N.W. Washington, DC 20006 (202) 857-0717

jrb51 51 l I CHAIRPERSON CCNNINGHAM-Thank you ver;' nuch, 1 2 Doctor. 3 Now we can turn it over to Leo Wade, and the menbers 4! of the advisory committee. 5 DR. WEBSTER: The last two speakers were in ny case 6: -- brought ne to the converted. 7 (Laughter.) 8 When asked to think abcut this I immediately thought l 1 9 of Rosalyn Yallow -- I think everybcdy knows her -- but she 10 presumably might not be qualified to head a clinic t, do Il radioimmunoassay work, if the loeic of this situation is pursued I 124 to its final conclusion. 13 I really agree with the speakers that the person wha I4 knows the business of radioimmuncassay -- whether he has an 15 M.D. or a Ph.D, or w latever decree he has, should be entitled i 16 to hold the license. I don't see an alternative to that. 17 { CHAIRPERSON CUNMINGHAM: Dr. Wacner? i 18 I DR. WAGNER: I might have been convinced until I I9 l heard the argunents presented by the two speakers. 20 t First of all, the last speaker said. he really didn't i 21 l see any difference between the diagnostic chemical orocedure 22 l and an ordinary chenistry assay; and I think that if he really 23 ! doesn' t understand the dif ference between takinn the respcn-24 ; sibility for somebody's life when you give a number, compared to A ..e.,.i n.c ,t., . inc, ,$ - whether you have the richt amount of an ingredient in a lipstick, s i

jrb52 52 i l' it raises a cuestion. i There are in this country laws that have been devised 3 ,i primarily that have to do with licensina of practitioners in ~

1. . medicine, which make a physician liable to malpractice suits 5

in a large body of law that prevents him frem actino as if it's 6 ; a simple chenical procedure. 7l I would think that for a lot of illnesses I wouldn't 8 want my dear friend, Rosalyn Yallow to take care of me, despite 9 the f act that she invented radioimmuncassays. 10 i So I think that -- I am not saying I think a nhysician i 11 ' should be in charge of these laboratories -- but I think 12 ' l we should be absolutely sure that the same licensing procedures i 13 ' - apply. t, I# And I would like to ask the two c_ ecc. le that ac. ceared j 15 what is the degree of liability that a person assumes.then he 16 crovides a number to a referring nhysician? And I think your I7 medical procedure, when one provides certain information and that 18 ! information was obtained erroneously and leads to somethine i 19 hazardous happening to the patient, I think your medical chysician 20 is responsible under malpracti laws. 2I Is the same degree of liability cbtaining when somebcdy 22 ; says your T4 is abnormally elevat 2d, an? it turns out it is 23 lnotabnormally elevated, and the patient has his thyroid 24 l' function turned down on the basis of a laboratory error; is there Am r.o. c n.oo,+.,s. inc. 25 > a responsibility for the person that recorts it as beine abnormally I i I

jrb53 53 i 1l high? 2 l! In our decartment where we do in vitro crocedures i 3 we are continually consulting about the medical problems associated 4; with these procedures, despite the f act t hat we have an 5 excellent Ph.D. scientist who does the chemical assay. Ne 6 ; are continually arguing about naking certain that we have 7, adequate M.D. backup for this Ph.D. chemist who does the proce-8 dures. 9: So I think that on the one hand, if a person really 10 - does not fully realize the decree of responsibility that you have 1 I 11 lwhen you do one of these procedures, then I would be very worried 12 ; about it. And maybe the chemistry departments aren't teaching 13 !this adequately. I If they aren't, I would then insist that a physician 14 I 15 ' be involved in a result if health care is cart of the issue. 16 j It really worries me that the American Society for 1 17 ! Clinical Chemistry really doesn't see what a physician does. It lal sounds as if thei think that what physicians do is something i 19 ; solely for the financial gain of the physician. l 20 ; The otner point that was made -- and this advisory i 21 !committee is not made up solely of physicians; in fact it seems 22 to me it's probably made un of more nonphysicians than physicians. N 23/k) there's a point of fact that was incorrect, that this is a 24 pery biased group of M.D. 's that are solely interested in their 4..e.e.<m a.cormt inc. ] 25 ywn economic welfare. d li

jrb54 54 I l I I wonder if the representatives could make comments 2 l. about those cuestions? 3: CHAIRPERSON CUNNINGHAM: Yes, Doctor? i 4I DR. BROUGHTON: For Dr. Nacner's information, I, too,* i S: am a physician. i 6 The clinical -- the number that is produced by any i 7! chemical laboratory, the lab director is liable for that number. 8 There is no question as to whether he is a physician or not a l 9l physician. 10 The interpretation of the numbers, how the attending t 11 physician caring the patient -- that is his ultinate responsibility, 12 ' how he uses that number, if that number is indeed correct. 13 If the number is wrong, the laboratory is liable. 1 I# I think that you perhaps missed the point on what 15 i we mean by the " simple chemical procedure". I think the most i 16 j complicated part of producing an accurate number in a radio-I7 l immunoassay is not the use of the isotope. It's the immuno-18 chemical procedure and the techniques that go before it. I 19 You can get equally accurate results b'r using an 20 enzyme or a bacteria. I 21 l DR. WAGNER: Can I make one comment as an internist? 22 I think it is niave to think that an internist today 23fisgoingtobeadequatelycompetent in all these ancillary i 24 l orecedures, so to speak. 4c..s.o r e neoo,ters. anc., 25 [ It was possible when I went through my training, it

jrb55 55 I was possible as an internist to be able to properly put these A 2 data into their proper perspective. 3 In my judgment it is absolutely im7ossible today for the best internist to be able to know enough r#wo 4l 5 CATscanning, nuclear medicin. laboratory medicine, immunology, 6 that he can judge these numbers accurately. 7l Our laboratory is constantly being beseiged by I 8 telephone calls from the referring physicians who want informa-9l tion that is of a clinical nature. A-d that's why I would be 10 a little bit hesitant in saying that the M.D. really doesn't fit into the picture with respect to these nunerical data. 12 I think you've gone too far. I think to say that the ; 13 M.D. is really just adding to the cost, it really -- in our 11 hospital, for many procedures we find that having another M.D. 15 in the loop, such as in CAT scanning, for example, decreases 16 total cost. l The idea of just grinding out numbers and saying l 18 ll these are really not chemical problems, this might lead to many 19 lmany mere studies being performed than if you did have some 20 clinical monitoring of the values and uses to which these i 21 ' i numbers were being out. 22 CHAIRPERSCII C! :CI !GUIN : Dr. Pagner, I an getting a 23 i i little confused here. 24 ' Certainly it is a ohysician who requests the tests to Am m.i n. corm. inc. 25 ; be done in the first place; is that not ccrrect? t i . ~....

jrb56 56 l l l li DR. WAGNER: Because the physician recuests it be done 1 2 ' does not mean he automatically knows how to incorporate the 3 result into the total care of the patient. 4' Frequently, because of the comnle::ity today, that will 5 not be possible. They will act'be -- the referrine physician 6 ' knows that the patient may have a thyroid problem, for example, 7' and then orders a certain number of thyroid tests. The numbers i 8! can be very confusing to that physician. I l 9! Doctor, would you not comment on that? Have you t lo never had complications for referring physicians about i l 11 thyroid problems as a result of the comolexities of these, on 12 I the part of the person that ordered the studies? 13 DR. BROUGHTON: If I -- 14 CHAIRPERSON CUNNINGHAM: Just a moment, Dr. Wagner, i 15 Dr. Broughton. i 16 i It seemseto me that the issue you are raising is not i 17 one of a questien of whether or not it may not be a physician 18 lthat does the in vitro study, but who interprets the results of I 19 ' that study. 20 ' And if you talk about liability, it still seems to me i 21 ' that the referrine physician has some responsibility for 22 how he uses the data that is given to him; if he indeed needs 1 23 somebody to interpret that data for him, he has access to other 24 !ichysicians. Aa-esceval Reporters, Inc. 25 DR. WAGNER: There is no questien but that the eerson i

57 ira 57 i II who orders the study is responsible for the patient. There's 2 no question about tha t. The question is, is the person who ordered che study 4jcompetent to analyze the data in everv case? 5 I think in many, many cases he is not comcetent to 6 ' analyze the data. I think he would be the first one to adnit 7 it. He, cherefore, wants to call on the advice of the person 8 who is the expert in tha; field. 9 CHAI2PERSOJ CUICCFJD.'t: Okay. 10 Then the question is: is the laboratory that orovides 11 l the data,also t.he study, in any way also responsible for the i interpretation of that data? Or are the'r just providine numbers? IU And the physician who accepts those numbers, is he responsible I# to be sure he understands those? And can interpret and acply ? I 15 i and use it for the natient's benefit? Or can he consult with 16 I somebody else? I II DR. UAGUER: In our institution there is a physician 18 linvolved in these loops, and these doctors are on salary -- their l 19 : economic well beinc does not depend on these consultations. 20 fThey are consulted verj. very frequently on the basis of proper 'l l] interpretation of the studies. il 22 l I think, I believe it is with some hesitation that i 23 I wculd do things that I would encourage or call cracticing Am.s.o.m neoorwn. w. ; There are all

medicine without a license to cractice medicine.

'S : kinds of people that want to do that. The same arguments are d

irb53 58 I i I presented with respect to at what level is a pediatrist allowed 2 [ to amputate? The podiatrists keep creeping un the lec. 3 (Laughter.) 4 And most people that advocate nedical licensure 5 try and keep pushing him further dawn toward the toenail. 6' (Laughter.) 7! CHAIRPERSON CL3NINGHA11: Dr. DeLand? 8 DR. DE LAND: Let me compliment Dr. Uagner's state-t 9 ment. By complinent I'm talking about the angle. l 10 I think the point Dr. Uagner is tr'rino to make is i 11 I that in any complicated laboratory test the usual procedure, i 12 the usual relationship is between physician and whoever heads up l 13 l the laboratory and the results, 14 As I interpret what you said, that the referring 15 ! physician can go find a consultation sonewhere alonc the line. 16 But that is not, shall we say, in the real world how it works. 17 lThe physician always comes back to the laboratory. 18 l. The other thing is to -- in experience it is not l 19 l uncommon to have a physician contact a laboratory and present 20 the problem to him; and then ask: what diagnostic procedures 21 l should I use? 22 This is not at all uncommon. I am sure we will not I 23 l find it very frequently at Johns Hopkins or other university 24 ! centers; but it is not uncommon -- because once a nan has been ACS PederM ROOOrtert, IM. 2S i out, as Dr. Collins noted, there has been an explosion of I

jrb53 59 I technology, and at the same tine, shall ue sa';, a certain i 2 ljexplosion of nonunderstanding. Say a man in practice for ten 3 years, a lot has gone under 'te dan in ten years, a lot that he 4 has not had the opportunity to gain e::cerience in. 5, So you look askance when I say to you that it would 6i not be uncommon for a man to ask the laboratory director, you 7 know, basically what tests shall we use in order to solve these l 8! oroblems? l 9! So that interface is not a figment but is a very real thing. I 10 l II i CHAIRPERSON CUNNINGHA!!: Thank vou. l 12 We will pause for a few minutes now to let the reporter 13 chance his tapes. Id (Recess.) 15 : MR. NUSSBAUMER (Presiding) : We will resume the l i 16 i meeting, ladies and gentlemen. t I7 ! To continue our discussion of the in vitro studies, 18 lare there other members of the committee that would like to l II ' comment on this matter? 20 Captain Briner? 21 l CAPTAIN BRINER: I find myself in the rare position l 22 hof agreeing with what everybody said. 23 (Laughter.) 24 j zg.s particularly rare when I can agree with Dr. Ace +sceral Rooornes, Inc. 25 Wagner and Dr. DeLand in that they are poles apart in what they i I i I

jrb60 60 l I come out with. !I 2 I would agree with you, Henry, that certainly in our 3 own in vitro laboratory at Duke Medi..-21 Center, which is a rather 4 small, Southern, country school, wherc we do about 60,000 1 5 in vitro studies a year, there is frequent contact from the 6: physician who orders the test with our laboratory and our 7! laboratory personnel, regarding not only how is the test done, 8 how we get our results, but in helping the interpretation of that 9l test as well. i 10 I agree with you completely that in many busy medical I 11 centers this is certainly ~ the case. 12 l On the other hand, I think we're kind of missing the 13 l point here: the discussion, it really I think should not border i 14 ' on who interprets the test; but from the standpoint of the 15 Nuclear Regulatory Commission, whose name is on the license? 16 l I think that's the bottom line that they're trying li 17 { to get at. 18 l And who actually interprets the result of a radio-19 l bicassay, while very, very important, may not be the answer i 20 l they're looking for. They are looking for an answer to tell them 21 l who really can have the license, procure for this, and use for 22 in vitro purposes that byproduct material? 23 ! Am I correct, Mr. Chairman? l 24 ' MR. NUSSBAUMER: Yes, you are. Ace receras Rooorters, Inc. ' 2S i What we're interested in is whether or not i 1

61 jrb61 i 1: we should change the statement that we've been using which says 2 j that material shall be used by and under the supervision of 3 a physician. 4 DR. WADE: I want to make one comment on that, i 5 without speaking in either of those directions. 6' The reason the question arose at all is we realize 7; that the physician may not be at all involved in the handling of a the material itself. On the other hand, in in vivo studies I 9, we also realize the physician may not be much involved in the 10 actual handling of the material itself; but the one thing that il ! distinguishes it is the individual named on the license as the 12 ' authorized user, is supposed to be responsible for interpretation l 13 l of results. l 4 14 ' And that's the reason physicians are listed as 15 authorized users for all in vitro studies. It's not just the 16 handling of it; it's the interpretation of results that's a 0 17 ; critical part of it. 18 ! That's why the issue comes up at all. l 19 ' DR. WEBSTER: I wculd like to point up a second 20 ' difference: and that is in one case the activity is injected 21 ' into the patient; in the other case it's injected into a test 22 ! tube. 23! And I think that makes a let of difference as to 24 whether the physician's name ought to be there or not.

4. r.emi n.conm w.

25 i MR. NUSSBAUMER: A very good point. h

jrb62 62 1 DR. WAGNER: Mr. Chairman, I think there is much more 2 ' harm done in the erroneous interpretation of nuclear medicine 3 procedures than there would be possibly involved in whether the 4, dose is injected properly. 'The potential for harming somebody 5 with an injected dose from a radiopharmaceutical is exceedingly 6 ' small. The potential for hurting somebody from the misinterpre-7i tation of a diagrostic test is exceedingly high. 8: And, there fore, I would reject out of hand the idea 9l that thenna[n function of the physician in an in vivo study is 10, to make sure that the dose is properly injected. 11 For example, I also A pet to believe that blood 9 12 ', pressure machines, where a person can put in 50 cents and get l 13 l his or her blood pressure taken, is not in the best interests of I 14 the American public; because the data are not properly utilized. 15 And I think I also would reject the concept that 16 ; the name on the license is different from the facr that you il i 17 { assume responsibility for the quality, and, insofar as you can, 18 l the proper interpretation of results, many of which may be very, l 19 very complicated. 20 i In our hospital for a new procedure, including in 1 21 l vitro procedures, for that study to be introduced into the 22 ll hospital, for a long period of time before the study is widely 0 23 ! done, it's necessary to have a physician in the loop, even before 24 ' the study is ordered. Am e wus Amorwrs. im. 25 ! Now, after a while, as physicians beccme more 'i l l

jrb63 I 63 I! accustomed to the study and learn how to use it, they can order i 2 1 the study without having to be screened by a physician who is 3 an expert in the use of this particular diagnostic test. 4, But the thing that I'm concerned about is I am 5 concerned with somebody writing to the NRC.and getting a license 6 i to do radioimmunoar c and then opening a radioimmunoassay 7 laboratory, and advertising that this person will now do 8 , radioimmunoassays on request by physicians, many cf whom, in my I 9l judgment, are not -- and I am not criticizing them; it's just 10 that the world of diagnostic medicine today is so complicated, I II ] that a physician must have available to him or to her, 12 ; consultants that will help him when problems arise. I i 13 ; These problems are medical problems. They are health Id care types of problems of the type that it is important not only 15 to have the knowledge that one gets by being a physician, and 16 going through training as a physician, but also by the pattern fl 17 of responsibility that the physician assumes. 18 So I would be hesitant to do anything that would I9 ! approve setting up multiple radioimmunoassay laboratories 20 !around, providing a large amount of numbers to any physician 21 fwho wants to order them. I would be very concerned about that. i 22 ! I think the country would be better served by adding 23 !h highly-qualified physician, supervising the study, where we 24 ]have a combination of the clinical and the chemical -- if you we.cce n.comn. inc. '5l looked at it that way.

jrb64 64 l l l I I think it would be equally foolhardy for a physician 2 j to do all of these procedures without a qualified chemist 2 involved in the loop -- just as I would not want anybody to take 4 care of me that had somebody who only had medical training, 5 without the additional chemical training -- I don' t want the 6 ' chemist doing the medical part of the procedure. 7 And I don't think that the referring physician is 8: adequate in all cases -- in many cases -- in many cases he or she-i 9; will not be; and you've got to have some other kind of a super-10 . visory -- it doesn't have to be the boss of the laboratory; you 11 could have a lay person; a chemist might be the president of the ' 12 llaboratory. 13 And I think a physician should be in that loop. i l 14 i In those laboratories where a physician is a rubber 15 1 stamp, I would eliminate that. I would say I would not give i 16 !a license to that situation, either. 17 l If I thought that the M.D. was strictly a rubber stamp, 18 % would then take the license away from that laboratory, too. 19 DR. WEBSTER: Yes, I hate to get into an argument -- t 20 ' (Laugnter.) 21 ! -- I would say that if you would allcw, for example, 22 h commercial laboratory to make a hemoglebin, that there would 9 23 be very little difference from allowing him to do an RIA test. l 24 In both cases you get a number back, the referring physician does, w...ece n.oo,ms, ice. 25 which he interprets. 1 l

jrb65 65 i k 1 I don't see that there's any sound difference. 1 2" DR. WAGNER: It's my un chrstanding that the Clinical l 3 Laboratory Improvement Act didn' t pass the Congress -- if I 4 understand correctly; and I think the same thing applies to 5 hemoglobin. 6 I don' t think there's anything really dif ferent about 7: radioimmunoassay. I think that anybody involved intimately 8 in health care delivery, whether it be taking electrocardiograms, 1 9: or nurse practitioners, should be under the supervision of a 10 physician, as the person who has the most training in dealing I II l with sick patients. The physician should be very closely in that 12,

loop, I

13 DR. WEBSTER: And he should be close enough in that t 14 j loop that he has to have his name on the license rather than on 15 the fellow who is actually doing the test? 16 l DR. WAGNER: Well, it seems to me, the name on the

t 17 l license signifies that that is the person who will be responsible 18 l for the medical use of that particular thing for which the license i

39 has been given. It's a medical license as I see it, not a 20 l chemical license. 21 ) CAPTAIN BRINER: I have a question for, I guess, 22 l Dr. Wade: 1 23 And while doing it, I will take a sly shot at you, 24 Henry. Ace.ceceret Recorters, Inc. 25 But one of the things you are worring about

jrb66 66 l! has in fact happened; there is a plethora of ccmmercial 2' laboratory establishments in this country, where there is no 3 physician involved in the commercial laboratory. 4 My question to the Commission is: how are these 5 places currently licensed? Or do they operate under a license? 6 DR. WADE: I guess most of them operate under the 7l general license of which we don't have any knowledge, whether 8i there is a physician or not. 1 i 9 MR. NUSSBAUMER: Dr. Broughton? 10 DR. BROUGHTON: In fact, the Clinical Laboratory t i II ! Improvement Act passed in 1967; the one that went through 12 l Congress this time was a new version. 13 And the one in 1967 did lay down qualifications for I i 14 i laboratory directors. 15 In regards to the licensing of those commercial 16 {! laboratories, other than using radioactivity, they are licensed I7 l through CDC to perform interstate commerce. I 18 CAPTAIN BRINER: I was referring to the byproduct i I9 materials license, Dr. Broughton, and not the CDC license. 20, DR. BROUGHTON: I have no idea hcw the license for 21 ! that -- in most cases they'll have a general license, I would 22 !I think. Ii 1 23 l MR. NUSSBAUMER: Dr. Broughton, could I ask you a 2d question? sa ecue noorms. w. 25 i How would you handle the matter of interpretation of I i

jrb67 67 t I the data, where there was not a physician involved with the 2? laboratory? 3 DR. BROUGHTON: The attending physician, the physician 4 who ordered it, has the responsibility of interpreting the data. 5 If he has difficult / interpreting it, he can consult with 6: whatever medical colleague he likes, either a pathologist if l 7. there's one around, or a endocrinologist. 8! And in practice, this is what happens. i 9: DR. HERNER: Perhaps I can add to that: 10 ; I have a commercial laboratory; it's in Rockville. Il f We specialize in radioimmunoassays. 12 l As far as interpretation is concerned, I have an 13 endocrinologist whom I can call upon if needed. Moreover, I Id ! can address the physician to this endocrinologist directly. 15 And this is the way we work it. 16 And I have been doing this for six years now; and !I 17 ! quite successfully. 18 l I would like to sort of comment on this general i l9 I area: 20. I am a Ph.D. chemist. I've been doing radioimmuno-21 l>assays for the past ten years. I've been doing radio chemistry 22 ll for 15. 1 23 ! I do terrific radioimmunoassays. 24 ' (Laughte r. ) A m.r.c.< R core <s.inc., 25. Now, I suspect that you gentlemen could also achieve l

jrb68 68 I! this level. But you'd probably be a little older than I am ~ 2L when you start, because this essentially i' -- it's analytical chemistry. And some of us are damned good. 4l And, Dr. Wagner, you have one of the outstanding 5 clinical chemists in the country working in your laboratory. 6! And your numbers are damned good. 7{ Now, in hospital situations, of course, there are 8 physicians, pathologists, chairmen of departments of nuclear 9' medicine, who can assist in interpretation. In my laboratory, 10 ' I have outside physicians. 11 l Now, there are certain things that I can do that 12 j many hospital labs don' t do. i I3 l For instance, I can do estrogen receptor assays; I Id j and to do this we trained our people at NIH for about five or 15 : six months. And this is something you don' t fool around with. i 16 ' You know, either you do it properly, or you don' t. I7 I And all I am saying to you is that as far as we can I8 see the significant thing is the analytical chemical procedure. 19 ' And we are very well trained to do that. 20 Now, I have a staff of six B.S. chemists, and that's 21 our business. We do analytical chemistry. We do analytical a 22 ' chemistry as applied to medical practice. And we think that this 23 is a very important thing. We take it very seriously. '4 But it is good analytical chemistry. Aa-,=-c a momn. w. ac MR. NUSSBAUMER: Dr. Wagner?

jrb69 69 i, i I DR. WAGNER: How can we get all of the laboratories 2 to do what you are doing? And these things I am advocating is 3 daat part of the loop includes an endocrinologist -- that 4 part of the loop. 5 In other words, that part of the loop -- which you 6-do -- is optional; and it seems to me it's conceivahla 7 not conceivable -- I think it is possible that people would not 8l have that part of your loop that you have. 9 You stated that you do call on your endocrinologist 10 from time to time to help in the interpretation of the clinical i 11 aspects of these studies. It seems to me the regulation as it 12 exists right now, which means that a physician has got to sign 13 l the license; if you assume that the physician is not going to i 14 i sign the license unless that physiciar. assumes certain respon-l 15 ! sibilities; then under the present regulations which we have 16 people will operate the way you operate, and the way we operate I7 ! -- exactly that way. 1 I8 i But I think if you eliminate the requirement for the 19 ' physician to be in the loop, as indicated by signing the license, 20 ! they need not operate in the way you in fact are operating. 2I ! DR. HERNER: I don't have a physician on my license. 22 I mean, I am director and president, and -- l 23 1 CAPTAIN BRINER: Which kind of license are you talking 24. about? Ac. mere necorms, ine.. 25 ' DR. EERNER: I am licensed by CDC, by the State of

70 jrb70 i i 1: Maryland; and I guess Maryland is an agreement State, so the 1 20 license to handle radioactivity, Medicare, Medicaid -- a ery 3 impressive list on my brochure. 4 (Laughter.) 5 But this does not come out, really. We -- there are 6' rather stringent requirements of CDC which the other agencies 7 sort of follow. 8j Generally speaking, when a physician asks for a test, 9 and we give him an answer, he generally knows what he's asking 10 ! for. I 11 Certainly there are problems, and these we refer to i 12 l physicians; but I think it's generally true of clinical chemists. I 13 that we don't interpret results. We are not trained to do 14 ! tha t. And we know that. i 15 And as a result, we go elsewhere; we go to competent 16 l physicians. I don't think that my laboratory is an exception; i 17 l really, I think that this is the way we handle it. I I8 We know that our expertise is in doing the tests, i 19 ! and if there's a problem in interpretation, we get somebody who i 20 i can do that for us. Certainly I know better than to try to 21 snow our medical colleagues; if I don' t know the answer, I tell i 22 - them: I don't know the answer, but I'll find it. 23! And that 's what we do. And it works fine. I 2# ' MR. NUSSBAUMER: Thank you very much, Dr. Herner. Am-Foceral Recorters, Inc. 25 DR. COLLINS: May I express my perspective? I f'

jf5 71 71 i 1l It's a dark and stormy night. We are approaching 2l the airpcrt. The public address system is playing. We hear 3 a dispute between the pilot, the navigator and the radar 4 operator. Who's in charge? The passengers are asked to vote. i 5 (Laughter.) 6' (Applause.) 7i MR. NUSSBAUMER: Very good. l 8 I think with that, we will ask Dr. Wade to advise on 9i this one. 10 ; DR. WADE: I think he already did. II ! (Laughter.) 12 Well, I don't know what we accomplished by bringing 13 this before the committee other than to air it publicly. I Id don't know that we are any closer to a resolution, at least by 15 consensus. 16 f I think there's two sides of the ssue we are present- .i 17 I ing quite well. One one hand we have the a,cment that i 18 i clinical lab results are used in diagnosis, and if they are 19 sometimes called, let's say, to consult on those diagnoses, it i 20 l should be done by a physician. 21 On the other hand we have an argument that these 22 ll require areas of expertise that is limited to clinical chemistry; h 23 and they spend their time doing what they are best at. 24 : There's a third factor from the agency's standpoint Am.coceret Aeoo, ten, Inc. 2S i that we have to consider, and that is our policy statement i

jr b72 l 72 l I! as published in proposed formt and in which we indicated that 2 we will intrude minimally into those areas that are regulated 3 by other agencies, i 4 And we do have an area here that is obviously 5 regulated by other agencies. So those are the factors that we 6 have to take into consideration. 7 MR. NUSSBAUMER: We would like to take the next i 8i items somewhat out of order on the agenda. We would like to 9i move now to Item VII-B, Delete the use of iodine-131 for 10 treatment of cardiac dysfunction from GroupTV. Il l I believe Dr. Holman wanted to comment on that, as I 12 ! he has to leave soon. l 13 ! DR. HOLMAN: Yes. Thank you very much. I IJ DR. WADE: May I interrupt? 15. I would like for background information for the 16 ll people here to make some remarks. I 17 i For background information, in 1971 FDA classified 18 this treatment as possibly effective, and I guess asked for i I9 ! evidence of safety and effectiveness. None was forthcoming. 20 ! So in 1976 FDA reclassified this treatment as lacking 21 substantial evidence of effectiveness. 22 ; The Nuclear Regulatory Commission has made a 23 ! practice of not authorizing procedures that have not been 24 approved by FDA, once we stopped evaluating safety and effective-ACW-P9Ceral Repormes, Inc. 25 i ness and FDA started; our policy has been to approve only those l l

jrb73 73 1 i I ! procedures that have FDA approval. 2 j, Usually that works from the other direction, scmeone 3 wants to use a procedure that has not been approved; and we say, 4 you have to get FDA approval first. This is the first one we've i 5 had that we go the other direction, where something was 6; reclassified, and we have had to consider whether we want to 7l reclassify it. I 8l There are several options to us I can uhink of. One 9! is not to license it. The other is to make no changes in our 10, regulations at all. And the third would be to remove it from i 11 l Group IV where it now is authorized and license it.! the 12 physician had submitted an IND to FDA. 13 There are at least those three possibilities; there 14, are obviously others, but just for discussion point I throw those 15 f out, i 16 MR. NUSSBAUMER: Okay, now, Dr. Holman? 17 DR. HOLMAN: Again, I am representing the American 18 i College of Cardiology, and we would like to urge that cardiac i 131 19 dysfunction not be deleted as an se6'aths for I; that is, 20 1 no change be made. 21 l The Nuclear Regulatory Commission is, of course, 22 considering the possibility of deleting as one of the i, 131 23 d potential applications of I therapy its use in cardiac 131 24 dysfunction. I therapy for the treatment of patients with Ac....c.r

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