ML18082A687
| ML18082A687 | |
| Person / Time | |
|---|---|
| Issue date: | 03/01/2018 |
| From: | Advisory Committee on Reactor Safeguards |
| To: | |
| Holiday, Sophie | |
| References | |
| NRC-3560 | |
| Download: ML18082A687 (91) | |
Text
Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION
Title:
Meeting of the Advisory Committee on the Medical Uses of Isotopes Docket Number: (n/a)
Location: teleconference Date: Thursday, March 1, 2018 Work Order No.: NRC-3560 Pages 1-91 NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.
Washington, D.C. 20005 (202) 234-4433
2 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION
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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
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TELECONFERENCE
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THURSDAY, MARCH 1, 2018
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The meeting was convened via teleconference at 2:00 p.m., Philip O. Alderson, M.D., ACMUI Chairman, presiding.
MEMBERS PRESENT:
PHILIP O. ALDERSON, M.D., Chairman VASKEN DILSIZIAN, M.D., Nuclear Cardiologist DARLENE F. METTER, M.D., Diagnostic Radiologist MICHAEL OHARA, Ph.D., FDA Representative CHRISTOPHER J. PALESTRO, M.D., Nuclear Medicine Physician MICHAEL A. SHEETZ, Radiation Safety Officer JOHN J. SUH, M.D., Radiation Oncologist LAURA M. WEIL, Patients Rights Advocate PAT B. ZANZONICO, Ph.D., Vice Chairman NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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3 NON-VOTING MEMBERS PRESENT:
RICHARD GREEN MEGAN SHOBER ZOUBIR OUHIB NRC STAFF PRESENT:
CHRISTIAN EINBERG, Acting Deputy Director, NMSS/MSST DOUGLAS BOLLOCK, ACMUI Designated Federal Officer SOPHIE HOLIDAY, ACMUI Alternate Designated Official and ACMUI Coordinator MARYANN AYOADE, NMSS/MSST/MSEB JENNIFER BISHOP, R-III/DNMS SAID DAIBES, Ph.D., NMSS/MSST/MSEB ROBIN ELLIOTT, R-I/DNMS SARA FORSTER, R-III/DNMS LATISCHA HANSON, R-IV/DNMS VINCENT HOLAHAN, Ph.D., NMSS/MSST ESTHER HOUSEMAN, OGC/GCLR/RMR DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB JAN NGUYEN, RI/DNMS PATTY PELKE, R-III/DNMS GRETCHEN RIVERA-CAPELLA, NMSS/MSST/MSEB RAEANN SHANE, NMSS NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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4 NRC STAFF PRESENT (cont.):
ZAHID SULAIMAN, R-III/DNMS KATHERINE TAPP, Ph.D., NMSS/MSTR/MSEB LESTER TRIPP, R-I/DNMS TARA WEIDNER, R-I/DNMS JENNY WEIL, OCA IRENE WU, NMSS/MSST/MSEB MEMBERS OF THE PUBLIC:
BETTE BLANKENSHIP, American Association of Physicists in Medicine (AAPM)
MARY BURKHART, Illinois Emergency Management Agency (IEMA)
DAVID BURPEE, Bayer Health Care WHITNEY COX, IEMA ROBERT DANSEREAU, New York State Department of Health BRIAN ERASMUS, British Technology Group (BTG)
SHERRIE FLAHERTY, Minnesota Radioactive Materials Unit KAREN FLANIGAN, New Jersey Radioactive Materials Program SANDRA GABRIEL, unaffiliated MUNIR GHESANI, NYU Langone Health BENNETT GREENSPAN, Society of Nuclear Medicine and Molecular Imaging (SNMMI)
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5 MICHAEL GUASTELLA, Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR)
CAITLIN KUBLER, SNMMI RALPH LIETO, St. Joseph Mercy Health System CAROL MARCUS, University of California at Los Angeles (UCLA)
RICHARD MARTIN, American Association of Physicists in Medicine (AAPM)
MICHAEL PETERS, American College of Radiology (ACR)
JOSEPHINE PICCONE, unaffiliated WAYNE POWELL, SNMMI A. ROBERT SCHLEIPMAN, Partners Healthcare EUGENIO SILVERSTRINI, Northwell Health BOBBY SMITH, Mississippi State Department of Health GLENN SULLIVAN, Cardinal Health CINDY TOMLINSON, American Society of Radiation Oncology (ASTRO)
TONY WANG, New York Presbyterian/Columbia University Medical Center JAMES YU, Yale School of Medicine NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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6 C-O-N-T-E-N-T-S Call to Order and Welcome..........................7 Opening Remarks....................................7 Report of the Subcommittee........................14 Comments and Questions............................19 Opportunity for Public Comment....................30 Closing Comments..................................77 Public Comments Submitted.........................85 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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7 1 P R O C E E D I N G S 2 2:06 p.m.
3 CHAIRMAN ALDERSON: (presiding) Good 4 afternoon, and welcome to today's ACMUI public 5 teleconference.
6 I'm Phil Alderson. I'm the current Chair 7 of the ACMUI.
8 Today we'll be discussing the topic of 9 the Interim Report on Training and Experience 10 Requirements.
11 I'll now turn this meeting to Mr. Bollock 12 from the NRC for opening remarks.
13 MR. BOLLOCK: Thank you, Dr. Alderson.
14 As the Designated Federal Officer for 15 this meeting, I'm pleased to welcome you to this 16 public meeting of the Advisory Committee on the 17 Medical Use of Isotopes.
18 My name is Doug Bollock. I am the Branch 19 Chief of the Medical Safety and Events Assessment 20 Branch, and I've been designated as the Federal 21 Officer for the Advisory Committee, in accordance 22 with 10 CFR Part 7.11.
23 Present today as the Alternate Designated 24 Federal Officer is Sophie Holiday, our ACMUI 25 Coordinator.
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8 1 This is an announced meeting of the 2 Committee. It is being held in accordance with the 3 rules and regulations of the Federal Advisory 4 Committee Act and the Nuclear Regulatory Commission.
5 This meeting is being transcribed by the 6 NRC, and it may also be transcribed and recorded by 7 others.
8 The meeting was announced in the January 9 23rd, 2018 Federal Register, Volume 83, page 3191.
10 The function of the Committee is to 11 advise the staff on issues and questions that arise 12 on the medical use of byproduct materials. The 13 Committee provides counsel to the staff, but does not 14 determine or direct the actual decisions of the staff 15 or the Commission. The NRC solicits the views of the 16 Committee and values their opinions.
17 I request that, whenever possible, we try 18 to reach a consensus on the various issues that we 19 will discuss today, but I also recognize there may be 20 minority or dissenting opinions. If you have such 21 opinions, please allow them to be read into the 22 record.
23 At this point, I would like to perform 24 roll call of the ACMUI membership participating 25 today.
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9 1 Dr. Phil Alderson?
2 CHAIRMAN ALDERSON: Here.
3 MR. BOLLOCK: Dr. Pat Zanzonico?
4 (No response.)
5 Okay. Dr. Vasken Dilsizian?
6 MEMBER DILSIZIAN: Here.
7 MR. BOLLOCK: Dr. Ronald Ennis?
8 (No response.)
9 Okay. Moving on, Dr. Darlene Metter?
10 MEMBER METTER: Here.
11 MR. BOLLOCK: Thank you.
12 Dr. Michael O'Hara?
13 MEMBER O'HARA: Here.
14 MR. BOLLOCK: Thank you.
15 Dr. Christopher Palestro?
16 MEMBER PALESTRO: Here.
17 MR. BOLLOCK: Thank you.
18 Mr. Michael Sheetz?
19 MEMBER SHEETZ: Here.
20 MR. BOLLOCK: Thank you.
21 Dr. John Suh?
22 MEMBER SUH: Here.
23 MR. BOLLOCK: Thank you.
24 And Ms. Laura Weil?
25 MEMBER WEIL: Here.
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10 1 MR. BOLLOCK: Thank you.
2 Dr. Zanzonico, did you join us on the 3 conference line?
4 MS. HOLIDAY: I think he might have 5 dialed in with a different passcode.
6 MR. BOLLOCK: Okay. So, we'll try to 7 get Dr. Zanzonico in, but we believe he is able to 8 listen to us at least at this point.
9 OPERATOR: Excuse me. This is the 10 operator. If he is on the line, he can press *0 and 11 I can open his line for him.
12 MS. HOLIDAY: Thank you.
13 MR. BOLLOCK: Okay. Also on the phone, 14 do we have Mr. Zoubir Ouhib?
15 MR. OUHIB: Here.
16 MR. BOLLOCK: Thank you.
17 Mr. Richard Green?
18 MR. GREEN: Here.
19 MR. BOLLOCK: And Ms. Megan Shober?
20 MS. SHOBER: Here.
21 MR. BOLLOCK: Thank you.
22 Mr. Zoubir Ouhib has been selected as the 23 ACMUI Therapy Medical Physicist. Mr. Richard Green 24 has been selected as the ACMUI Nuclear Pharmacist, 25 and Ms. Megan Shober has been selected as the ACMUI NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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11 1 Agreement State Representative. Messrs. Ouhib and 2 Green and Ms. Shober are pending security clearance, 3 but may participate in the meeting. However, they 4 do not have voting rights at this time.
5 I now ask NRC staff members who are 6 present to identify themselves. I'll start with the 7 individuals in the room here.
8 DR. HOLAHAN: Vincent Holahan.
9 MS. WU: Irene Wu.
10 DR. DAIBES: Said Daibes.
11 MS. HOLIDAY: Sophie Holiday.
12 MS. HOUSEMAN: Esther Houseman.
13 DR. HOWE: Donna-Beth Howe.
14 MR. EINBERG: Chris Einberg.
15 MS. HOLIDAY: Dr. Katie Tapp is also on 16 the phone.
17 MR. BOLLOCK: All right. Okay. Now 18 I'll go to the NRC Headquarters employees on the 19 phone. Are there any other employees on the phone?
20 MS. HOLIDAY: Maryann Ayoade is also on 21 the phone.
22 MR. BOLLOCK: Okay. Thank you.
23 Members of the public who notified Ms.
24 Holiday that they would be participating in our phone 25 conference will be captured in the transcript. Those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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12 1 of you who did not provide prior notification, please 2 contact Ms. Holiday at sophie.holiday@nrc.gov.
3 That's S-O-P-H-I-E dot H-O-L-I-D-A-Y @nrc.gov. Or 4 her telephone number is 301-415-7865.
5 We have a bridgeline available, and that 6 phone number is 888-790-6447. The passcode to access 7 the bridgeline is 2790867 followed by the pound key.
8 It is also using the GoToWebinar 9 application to view the presentation handouts real 10 time. You can access this by going to 11 www.gotowebinar.com and searching for the meeting ID 12 506-651-115.
13 The purpose of this meeting is to discuss 14 the Draft Report for the standing ACMUI Training 15 Experience Subcommittee. Individuals who would like 16 to ask a question or make a comment regarding a 17 specific issue the Committee has discussed should 18 request permission to be recognized by the ACMUI 19 Chairperson, Dr. Philip Alderson. Dr. Alderson, at 20 his option, may entertain comments or questions from 21 members of the public who are participating with us 22 today.
23 Comments and questions are usually 24 addressed by the Committee near the end of the 25 presentation after the Committee has fully discussed NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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13 1 the topic. We ask that one person speak at a time, 2 as this meeting is also closed captioned.
3 I would also like to add that the 4 handouts and agenda for this meeting are available at 5 the NRC's public website.
6 At this time, I ask that everyone on the 7 call who is not speaking to place their phones on 8 mute. If you do not have the capability to mute your 9 phone, please press *6 to utilize the conference line 10 mute and unmute functions. I would ask everyone to 11 exercise extreme care to ensure that the background 12 noise is kept at a minimum, as any stray background 13 sounds can be very disruptive on a conference call 14 this large.
15 At this point, I would like to turn the 16 meeting back over to Dr. Alderson.
17 VICE CHAIRMAN ZANZONICO: Doug, this is 18 Pat Zanzonico. Can you confirm that you can now hear 19 me?
20 MR. BOLLOCK: Hi, Dr. Zanzonico. Yes, 21 we can hear you. Thank you.
22 VICE CHAIRMAN ZANZONICO: Thank you.
23 CHAIRMAN ALDERSON: Thank you. Good to 24 have you with us, Dr. Zanzonico.
25 This is Dr. Alderson. And as was said NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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14 1 before, we are discussing today the Interim Report of 2 the Committee's Subcommittee on Training and 3 Experience Requirements. The members of that 4 Subcommittee are Dr. Darlene Metter, Dr. John Suh, 5 Ms. Laura Weil, and Dr. Christopher Palestro, who is 6 the Chair of the Subcommittee.
7 I will now turn the meeting over to Dr.
8 Palestro.
9 MEMBER PALESTRO: Thank you, Dr.
10 Alderson.
11 And as Dr. Alderson indicated, this is 12 our Subcommittee's Draft Interim Report. I would 13 like to extend my thanks to Drs. Darlene Metter and 14 John Suh and to Ms. Laura Weil for their invaluable 15 contributions and efforts to put this report 16 together.
17 I begin with the charge of this 18 Committee. And the specific charge of this 19 Subcommittee is to periodically review the training 20 and experience requirements that are currently in 21 effect for all modalities, which includes both 22 unsealed byproduct materials, 10 CFR 35.100, 200, 23 300, and 1000, as well sealed byproduct materials, 24 35.400, 500, 600, and 1000, and to make 25 recommendations for changes as needed.
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15 1 The guiding principle of our Subcommittee 2 is that we recognize that any recommendations for or 3 against changes in training and experience should 4 ensure that the requirements and provisions in Part 5 35 which, quote, "provide for the radiation safety of 6 workers, the general public, patients, and human 7 research subjects," closed quotes, are satisfied, 8 while simultaneously ensuring that patient access to 9 these procedures is not unnecessarily compromised.
10 And I think it would behoove us to review 11 some of the background, as it gets a bit complicated.
12 In June 2015, as a result of concerns expressed by 13 various stakeholders, a Subcommittee was formed to 14 determine if the 700-hour training requirement placed 15 a hardship on patient access to alpha- and beta-16 emitting therapeutic radiopharmaceuticals and, if 17 necessary, to make recommendations for potential 18 changes and establish recommendations for the total 19 number of hours of training and experience for use of 20 unsealed byproduct material for which a written 21 directive is required. 10 CFR 35.390.
22 Based on its investigation, the 23 Subcommittee concluded that the current requirement 24 of 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> for Authorized Users does not adversely 25 affect patient access to these radiopharmaceuticals NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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16 1 and that no change in the training and experience 2 requirements was warranted.
3 The Subcommittee did note, however, that 4 nearly 15 years had passed since the requirements had 5 been updated and recommended that the ACMUI form a 6 subcommittee to periodically review the training and 7 experience requirements for all modalities currently 8 in effect, and to make recommendations for changes as 9 needed. The ACMUI accepted this recommendation, and 10 the Subcommittee on Training and Experience 11 Requirements for All Modalities was formed.
12 The Subcommittee developed a procedure 13 for review of the training and experience 14 requirements, and in order to optimize the review 15 process, planned to begin with 10 CFR 35.100, 16 followed by 35.200, 35.300, et cetera. Due to 17 ongoing concerns about patient access, however, the 18 Subcommittee was directed to prioritize the review of 19 the training and experience requirements for use of 20 unsealed byproduct material for which a written 21 directive is required.
22 Current status. There have been two 23 developments since the ACMUI recommended against 24 changing training and experience requirements under 25 10 CFR 35.390. On January 26th, 2018, the United NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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17 1 States Food and Drug Administrative approved 2 lutetium-177 dotatate for treatment of certain 3 neuroendocrine tumors, given the encouraging results 4 that had been obtained with this agent in clinical 5 trials.
6 In contrast to other therapeutic 7 radiopharmaceuticals which have been approved for 8 very specific situations or indications, such as when 9 other treatments have failed, the indications for 10 lutetium-177 dotatate are much broader and include 11 treatments of somatostatin receptor-positive 12 gastroenteropancreatic neuroendocrine tumor, or 13 GEP-NETs, N-E-T-S, including foregut, midgut, and 14 hindgut neuroendocrine tumors in adults. And that 15 is from the NDA 208700 approval letter from the FDA.
16 Given the excellent results obtained with 17 lutetium-177 dotatate in clinical trials, the broad 18 indications for its use, and the fact that 19 neuroendocrine tumors are now the second most common 20 gastrointestinal tumor, it is likely that there will 21 be considerable demand for this agent.
22 In another interim development, the 23 Subcommittee notes with some concern a precipitous 24 decrease in the number of first-time candidates 25 sitting for the certification examination of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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18 1 American Board of Nuclear Medicine. In 2016, fewer 2 than 50 individuals sat for this examination, in 3 contrast to 80 to 100 individuals in the past.
4 Furthermore, a review of 5 the Accreditation Council for Graduate Medical 6 Education database shows a steady decline over the 7 past decade in both the number of nuclear medicine 8 residency programs and the number of residents 9 enrolled in those programs from 57 programs with 161 10 residents in academic year 2007-2008 to 41 programs 11 with 75 residents in academic year 2017-2018. While 12 it is difficult to judge the impact of this decline 13 on patient access, the numerous letters that have 14 been written and the discussions and presentations 15 on this topic that have taken place over the past few 16 years have focused on whether or not there is a 17 sufficient number of Authorized Users. No data had 18 been offered to suggest there is a surplus, nor have 19 future needs been addressed. Thus, the Subcommittee 20 views the decrease in the number of nuclear medicine 21 physicians as a potentially serious problem, perhaps 22 not immediately, but certainly in the future.
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19 1 in the number of Authorized Users, the Subcommittee 2 believes that it is time to reconsider the creation 3 of an alternative pathway for Authorized Users for 4 10 CFR 35.390, training for use of unsealed byproduct 5 material for which a written directive is required.
6 While the requirements of an alternative 7 pathway are beyond the scope of this Interim Report, 8 the Subcommittee offers the following items for 9 consideration:
10 The length and scope of the training; 11 The minimum number of administrations 12 that an individual must perform, and whether a total 13 number is sufficient or a specific number per class, 14 alpha and beta; 15 Written certification versus formal 16 examination, and maintenance of competence.
17 The Subcommittee welcomes comments and 18 suggestions.
19 And that concludes the report.
20 MS. HOLIDAY: So, at this time, are there 21 any comments from members on this Subcommittee?
22 MEMBER SUH: This is John Suh.
23 I agree with what has been said in the 24 report.
25 MEMBER METTER: This is Darlene Metter.
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20 1 I agree, too. And I would also like to 2 also mention that in Dr. Palestro's final sentence or 3 near the end, the length and scope of training I think 4 is going to be very important, too, as far as a 5 curriculum development. And, again, assessment of 6 competencies is going to be highly important.
7 MR. GREEN: This is Richard Green.
8 I'm very appreciative of the thorough 9 report and the time taken by the Subcommittee.
10 It's interesting to note that, as stated, 11 nearly 15 years have passed since this was last 12 updated. And being a fan of history, it would be 13 interesting to determine how these values were 14 established. The world certainly has changed. The 15 numbers of radiopharmaceuticals and prices and 16 classes have changed. I think it's certainly time 17 to reevaluate what these values were and what they 18 might be going forward.
19 MEMBER PALESTRO: This is Dr. Palestro.
20 If I can respond to Mr. Green's comment?
21 The answer is we have spent a good deal 22 of time, and NRC staff has put in a lot of time, 23 trying to ascertain how particularly the number of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> were established. And the answer is it just 25 simply isn't clear from the historical data that are NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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21 1 available. I mean, I think we all agree that the 2 numbers were established with the concept of ensuring 3 the highest quality and safety of care, but why those 4 numbers, in particular, were chosen simply is just 5 not obvious.
6 VICE CHAIRMAN ZANZONICO: This is Pat 7 Zanzonico.
8 I would like to ask a question. If I 9 understood correctly, Dr. Palestro, the Subcommittee 10 concluded that, at least at the moment, there was no 11 shortage of Authorized Users that was currently 12 restricting patient access to these procedures. And 13 that's, obviously, an important criterion, among 14 others, in evaluating whether training requirements, 15 training and experience requirements need to be 16 adjusted.
17 The specific question I have is, as long 18 as the judgment is that there is no shortage of 19 Authorized Users and no restriction in terms of 20 patient access, is there any compelling reason, did 21 the Subcommittee think there would be any compelling 22 reason to offer the training and experience 23 requirements? For example, assuming there is 24 adequate access, patient access, would you still 25 consider either decreasing or increasing the number NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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22 1 of hours and other training and experience 2 requirements? Or is it necessarily tied to the issue 3 of patient access?
4 MEMBER PALESTRO: Yes, this is Dr.
5 Palestro.
6 In response to your question, the 7 Subcommittee was formed with the express intention of 8 going through each of the various 35 hundred parts to 9 try to sort that out and determine what, if any, 10 adjustments needed to be made. However, as I 11 indicated in the report, we've been directed to focus 12 specifically on 35.390 because, even though the 13 previous Subcommittee had found no evidence of 14 limiting patient access, these concerns were still 15 expressed by various stakeholders. And now, it is 16 complicated potentially by the fact that we have this 17 new lutetium-177 dotatate coupled with a decrease in 18 the number of nuclear physicians.
19 So, the answer to is there a shortage at 20 the present time, based on what the Subcommittee 21 presented and reviewed, and the ACMUI endorsed two, 22 or maybe it's coming up on three years ago, not at 23 the present time. But we are looking towards the 24 future. I think there is, and I hope I conveyed it 25 in the report, that the potential exists for a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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23 1 shortage in the future. And I personally feel -- and 2 I think the Subcommittee would agree with me -- that 3 it would be better to be proactive rather than 4 reactive, as these things take time to develop.
5 VICE CHAIRMAN ZANZONICO: Understood.
6 Thank you.
7 MEMBER WEIL: If I may add -- this is 8 Laura Weil -- while the Subcommittee's research found 9 no evidence of shortage of Authorized Users, I think 10 it would be a mistake to state that we found that 11 there was demonstrable adequate numbers of Authorized 12 Users in all healthcare settings and in all areas of 13 the United States. We saw no evidence that there is 14 shortage, but we can't say affirmatively that there 15 are enough Authorized Users in all places.
16 MEMBER SHEETZ: This is Mike Sheetz.
17 I'd like to thank the Subcommittee for 18 their work on this topic, and I understand it's a 19 controversial issue.
20 However, I would be cautious in creating 21 an alternative pathway for a use covered under 10 CFR 22 35.390. In my experience, this category includes a 23 multitude of radiopharmaceutical therapies which 24 requires a strong background and understanding in 25 radioprotection, radionuclide handling, and clinical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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24 1 patient care.
2 While some of these therapies may be 3 relatively straightforward with minimal radiation 4 safety issues, others such as the new lutetium-177 5 therapy involves a complex administration procedure, 6 you know, with medical health physics and radiation 7 safety concerns. So, again, therefore, we need to 8 be cautious in reducing the training and experience 9 requirements for this category of radiopharmaceutical 10 therapy.
11 The current training requirements for 12 35.390 require an AU to be Board-certified in nuclear 13 medicine or radiation oncology or, essentially, have 14 completed the equivalent residency program training.
15 I think it's essential for physicians to have this 16 broad background and training provided by these 17 medical specialties to be approved as an AU for 35.390 18 uses. So, I would look to these medical specialty 19 boards to establish what the appropriate training and 20 experience is to practice radiopharmaceutical therapy 21 covered under 35.390.
22 And with respect to the potential patient 23 access issue, I would also look to these medical 24 specialty boards for them to address and make the 25 determination for any changes in current regulatory NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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25 1 requirements.
2 Thank you.
3 MEMBER PALESTRO: This is Dr. Palestro.
4 Thank you for the comment. In response, 5 I guess because there's been so much discussion about 6 decreasing requirements and shortening the, 7 quote/unquote, "number of hours," nowhere in the 8 report, nor is it in the Subcommittee's concept, that 9 the thoroughness of training be limited or that an 10 insufficient amount of training and experience and 11 education result. Whatever 12 suggestions/recommendations made going forward would 13 be made with the concept that any individuals going 14 through the alternative or alternative pathway would 15 have sufficient education, training, and experience.
16 MR. OUHIB: This is Zoubir Ouhib.
17 I will have to echo what was just said, 18 and I think the idea that perhaps, while not proven, 19 that there might be a shortage of Authorized Users, 20 I think lowered the standards will be a huge mistake, 21 in my opinion, which would potentially lead to some 22 outcome that would not be desirable. So, I think the 23 Committee has put a very solid document here to 24 follow.
25 Thank you.
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26 1 MEMBER DILSIZIAN: Vasken Dilsizian 2 here.
3 I guess I just want to bring in the 4 perspective of a cardiologist and non-nuclear 5 medicine radiologist who happened to go beyond the 6 cardio training to adequate training to be able to 7 interpret nuclear medicine studies along with nuclear 8 cardiology.
9 So, what I'm saying is that, if there are 10 oncologists, cardiologists, endocrinologists, 11 neurologists who are interested in contributing to 12 the field of science, advancing medical care, 13 providing patient care, after having fulfilled 14 appropriate training as defined by the Committee or 15 by these societies, then this alternative pathway 16 should be available to those physicians. There's no 17 reason why we should not have others who are 18 interested in expanding the field like cardiologists 19 have done. Nuclear cardiology has blossomed since 20 nuclear cardiologists have had access to the imaging, 21 has had a multitude of prognostic outcome data. The 22 field has grown; patients have benefitted. I don't 23 think that we should have a blind approach to not 24 including other medicine subspecialties besides 25 imaging.
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27 1 So, I support the concept of defining 2 what it would take to be a competent physician to 3 administer the therapy dose and, then, allow any of 4 the physicians or subspecialties to determine whether 5 they're willing to go through that pathway.
6 MEMBER METTER: This is Darlene Metter.
7 What Vasken just said pretty much is what 8 I believe, in my view, what an alternate pathway is.
9 An alternate pathway is another pathway to achieve 10 the same result. And so, these individuals should 11 have the equal competence as someone who has been 12 certified as a Diplomate of the ABR/ABNM or Radiation 13 Oncology Board certification.
14 I think the problem that we were dealing 15 with was, how do you assess competency in the sense 16 of hours? You have to have a good curriculum for 17 sure, but how do you assess competency? Is it going 18 to be a formal exam or is it going to be just through 19 Board certification? Or what are the pathways do we 20 look at to assess an individual's competency for the 21 radiopharmaceuticals that they'll be administering?
22 MR. GREEN: This is Richard Green.
23 I'd like to echo some of Dr. Palestro's 24 comments. And just evaluation of the T&E 25 requirements never has been equated with reducing; NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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28 1 it's evaluating. But we never had alpha emitters in 2 commercial use, in commercial availability, as we do 3 today. Fifteen years ago when these T&E requirements 4 were evaluated, we never had a mixed beta-gamma 5 emitter like lutetium administered in three courses 6 of therapy at 200 millicuries each.
7 So, we need to evaluate whether what we 8 have today is appropriate and, as Dr. Metter and Dr.
9 Dilsizian have said, make sure that physicians who 10 are supervising these therapies and treating these 11 patients have the right training and experience that 12 is now equated with a decrease. You have to evaluate 13 the adequacy of training and what is really needed to 14 treat patients and meet patients' needs, and they 15 will go wherever that happens to go.
16 CHAIRMAN ALDERSON: This is Dr.
17 Alderson.
18 Are there further comments from the 19 Committee?
20 MEMBER PALESTRO: Yes, Dr. Alderson, 21 it's Dr. Palestro.
22 I just want to reiterate -- and again, to 23 eliminate any potential confusion -- that the 24 Subcommittee, or that the alternative pathway is not 25 necessarily equated with reducing the number of hours NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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29 1 or a shortcut to qualifying for being able to 2 administer these various agents. It's simply just 3 that an alternative pathway could turn out qualified, 4 equally qualified, equally competent individuals.
5 CHAIRMAN ALDERSON: All right. Yes, 6 good. Well said. Well said.
7 Are there further comments from members 8 of the Committee before this goes to the open 9 conference call, to the public?
10 MEMBER SHEETZ: This is Mike Sheetz.
11 I just have one thing to point out. In 12 the current 35.390 requirements, there is an 13 alternative pathway to Board certification, and it 14 includes 700 hours, 200 of which have to be in 15 didactic classroom radiation physics, protection, 16 radiochemistry, radiobiology. So, there exists an 17 alternative pathway to Board certification, but it 18 requires 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. So, I think the issue is, do we 19 come up with a different set of alternatives or 20 criteria than the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />?
21 CHAIRMAN ALDERSON: Are there other 22 comments from the ACMUI?
23 (No response.)
24 Hearing none, I think it's time, then, to 25 go to the operator and see if we have people on the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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30 1 phone who would like to make a comment.
2 OPERATOR: If you would like to ask a 3 question, please press *1 from your phone, unmute 4 your line, and speak your name clearly when prompted.
5 If you would like to withdraw your question, please 6 press *2.
7 One moment while we wait for the first 8 question.
9 (Pause.)
10 Our first question comes from Cindy 11 Tomlinson, ASTRO.
12 Your line is open.
13 MS. TOMLINSON: Thank you.
14 Chairman Alderson, this is Cindy 15 Tomlinson with ASTRO. Can you hear me okay?
16 CHAIRMAN ALDERSON: Yes, fine.
17 MS. TOMLINSON: Okay. Great.
18 So, I just wanted to thank you for 19 allowing to provide this statement on behalf of ASTRO 20 in response to the Subcommittee's report discussed 21 today. I did submit a written statement. So, I'm 22 just going to summarize what we've stated there.
23 As we stated in October of 2016 to the 24 ACMUI, ASTRO strongly opposes any reduction in the 25 training and experience requirements found in 10 CFR NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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31 1 35.390. We believe that these requirements are 2 appropriate, protect the safety of patients, the 3 public, and practitioners, and should not be changed.
4 Radiopharmaceuticals are highly 5 effective in treating cancer, but also potentially 6 hazardous drugs with probable harmful effects to both 7 the patient and the public if not used correctly and 8 under the supervision of a highly trained physician.
9 The rigorous T&E requirements contribute 10 to the excellent safety record of 11 radiopharmaceuticals. We believe that it is 12 important that the person administering the 13 radiopharmaceuticals is appropriately trained in the 14 safe handling, exposure risks, and the management of 15 side effects of radiation.
16 In its report, the Subcommittee expressed 17 its concerns with the decline in the number of nuclear 18 medicine physicians sitting for the certification 19 examination of the American Board of Nuclear 20 Medicine. However, the Subcommittee does not 21 discuss other AUs, including radiation oncologists.
22 The American Board of Radiology estimates 23 that, between 2007 and 20017, approximately 1,650 24 radiation oncologists have been certified by the ABR 25 with an Authorized User eligibility definition and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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32 1 may become Authorized Users. In addition, ASTRO 2 estimates that there are approximately at least 2200 3 radiation oncology facilities in the U.S., which 4 means that, aside from nuclear-medicine-trained AUs 5 nationwide, there are likely enough AUs just among 6 the radiation oncologists.
7 We are not aware of a perceived shortage 8 of radiation oncologists anywhere in the country.
9 However, without being able to identify which AUs are 10 licensed under 35.390 and 35.300, it is not possible 11 to confirm whether there is an actual AU shortage or 12 just a perceived one. Additionally, ASTRO has not 13 heard what would be an ideal number of AUs. Our 14 members are ready to care for patients needing any 15 radiopharmaceutical.
16 In conclusion, for those reasons, we 17 oppose reduction in the T&E requirements for 18 10 CFR 35.390, and we look forward to providing input 19 to the Subcommittee as it continues its 20 deliberations.
21 Thank you.
22 CHAIRMAN ALDERSON: Yes. Thank you for 23 that statement.
24 Would anyone on the ACMUI like to 25 comment?
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33 1 MEMBER PALESTRO: Yes, Dr. Alderson, 2 it's Dr. Palestro. I have a couple of questions, 3 actually.
4 CHAIRMAN ALDERSON: Please.
5 MS. TOMLINSON: Okay.
6 MEMBER PALESTRO: Okay. Question No. 1, 7 according to your letter, about 1,650 radiation 8 oncologists have been certified with Authorized User 9 eligibility over the past decade, which translates 10 into 165 per year. And I'm just using an average.
11 If we look at nuclear medicine AUs during that same 12 time, based on Board certification, it's roughly 13 about 80 per year. So, all together, over the past 14 10 years, we've been -- or I should say there are 15 about 245 AUs being authorized between these two 16 groups. And I'm not including diagnostic radiology 17 because I really don't know those numbers.
18 However, if, in fact, the trend in 19 nuclear medicine holds, where we've decreased from 20 about 80 down to 40 or 45, that's a 16-percent 21 decrease in incoming or newly authorized AUs, if you 22 will, per year. I don't know how to judge that, but 23 that, to me, is a substantial decrease. If we were 24 to take a very critical view or a very severe view, 25 if all nuclear medicine AUs disappear, and we're NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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34 1 talking 85 for those per year or 80 per year, that's 2 a decrease of 35 percent in the total of new AUs, new 3 individuals becoming AUs each year. So, again, 4 those, to my way of thinking, really are numbers to 5 be concerned about.
6 And then, the next question is, you said 7 likely enough AUs just among the radiation 8 oncologists. I would like to know, because this is 9 something that we grappled with a couple of years ago 10 and everyone continues to grapple with, on what basis 11 can you conclude, or do you conclude, that there are, 12 in fact, likely to be enough AUs just based on 13 radiation oncologists alone?
14 MS. TOMLINSON: Right. So, when this 15 issue came up a couple of years ago, we asked the NRC 16 to see if we could get numbers for how many AUs are 17 licensed under 35.390 and under 35.300. And the NRC 18 is unable to do that with any certainty because of 19 the way that they track Authorized Users and with the 20 Agreement States. So, it's really hard for us to -- I 21 mean, I think we're both in agreement that we just 22 don't know, right?
23 MEMBER PALESTRO: Yes. Okay. Yes.
24 MS. TOMLINSON: Yes, we don't know. We 25 don't know what an ideal number is, either.
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35 1 MEMBER PALESTRO: That's correct.
2 MS. TOMLINSON: So, without knowing 3 that, it's hard to say if a decline is okay or not 4 okay.
5 MEMBER PALESTRO: Okay.
6 MS. TOMLINSON: So, I think it would be 7 helpful if there were some way for the NRC to -- and 8 I don't know, again, if this is something that they 9 can -- I mean, I'm assuming it would take some time, 10 but to figure out exactly who's licensed under which 11 provision in the regs, because without that 12 information, we're just not going to -- I don't know 13 how you necessarily move forward.
14 MEMBER PALESTRO: The answer is I agree 15 with you; it's really a complicated issue. I mean, 16 if I'm going to misspeak, then, certainly, staff can 17 correct me, but, as I recall, it's almost impossible 18 to determine the number of AUs because, for example, 19 we have a broad license and the AUs are really in-20 house. The state doesn't have numbers for each 21 individual AU. So, it becomes very complicated. I 22 agree with you there.
23 Would you agree with me that there's 24 probably not a surplus they use for these procedures?
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36 1 agree or disagree with you on that.
2 MEMBER PALESTRO: Okay. And then, 3 again, I'm just going to reiterate -- and I will 4 continue to reiterate -- that the alternative pathway 5 does not imply, at least not to me, not to my 6 Subcommittee, or to the ACMUI, that less-well-7 trained, less-well-educated, less-well-experienced 8 individuals will become AUs.
9 MS. TOMLINSON: I don't disagree with 10 that. I think our concern is that, if you relax 11 those requirements and there's not equal competency, 12 as was mentioned earlier, then that would be 13 concerning.
14 MEMBER PALESTRO: Yes, we agree with you.
15 I think the hang-up or the issue that we get into is 16 trying to equate hours with competency.
17 MS. TOMLINSON: Right.
18 MEMBER PALESTRO: And so, I think, 19 potentially, the way around that is to decide what 20 constitutes the knowledge base, if you will, that 21 these individuals should have in order to be granted 22 AU status, and devise a way to determine whether or 23 not they possess that knowledge, whether or not they 24 possess the competency. And I'm not convinced, and 25 I think the educational paradigm of the 21st century NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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37 1 is not convinced, that necessarily hours are the way 2 to do, that there are better ways to do it, 3 examinations, and so forth.
4 MS. TOMLINSON: Right.
5 CHAIRMAN ALDERSON: Excellent comments.
6 Further comments from the ACMUI?
7 MR. OUHIB: This is Zoubir.
8 I just have a question regarding the 9 competency. Now, when you move forward and you have 10 additional users or a larger number of users, and you 11 have an Authorized User that's doing a procedure a 12 year -- I'm going to exaggerate here for a 13 second -- how do you define whether that individual 14 is competent by performing one or two procedures a 15 year, year after year?
16 CHAIRMAN ALDERSON: That's your 17 question?
18 MR. OUHIB: Yes, that is my question.
19 CHAIRMAN ALDERSON: I'll try to step in 20 on that one for a moment. We have to understand, and 21 as part of this call, the scope of the ACMUI's 22 position here. I think, ultimately, we, after much 23 further study and input from the public, might advise 24 the NRC in a particular way, but we would never be 25 the organization responsible for establishing and NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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38 1 policing all of these kinds of documentation. As 2 someone earlier said, I mean, it's probably going to 3 roll back to the certifying boards or some other 4 organizations that might be chosen to recommend or to 5 employ such approaches. So, we're a long way from 6 there.
7 And in the same way, since I'm on metrics 8 for a minute, I do understand the discussion 9 revolving around the number of AUs. Out of respect 10 to some of our public input on this issue over the 11 last couple of years, the input has been not simply 12 the metric, but the distribution of the AUs and the 13 concern that in certain areas of the country there 14 was a significant dearth of AUs. So, that particular 15 geographic issue can't be exactly related to the 16 average number of AUs.
17 Would anyone like to comment on Zoubir's 18 proposition?
19 (No response.)
20 Hearing none, then, I think we're ready 21 for the next call.
22 MR. GREEN: Dr. Alderson, this is 23 Richard. May I make a comment quickly?
24 CHAIRMAN ALDERSON: Certainly.
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39 1 made by the individual from ASTRO, representing 2 ASTRO, and I apologize for forgetting her name. But 3 I have to take a moment to -- there was a statement 4 made that radiopharmaceuticals are highly effective 5 in treating cancer, but are potentially hazardous 6 drugs with possible harmful effects to both the 7 patient and the public if not used correctly.
8 I agree with the statement with the 9 exception of the term "hazardous drugs," which has a 10 definition defined by the -- hazardous drugs is 11 defined by the National Institute of Occupational 12 Safety and Health, or NIOSH, of the Centers for 13 Disease Control and Prevention, the CDC. They 14 publish a NIOSH list of antineoplastic and other 15 hazardous drugs in the healthcare setting that is 16 updated annually. This is now, the standards for 17 handling hazardous drugs is defined by USP Chapter 18 800, which was made official last year. And the 19 definition, according to the Draft Hazardous Drugs 20 Policy and Procedures, NIOSH defines a hazardous drug 21 as "a drug that is approved for human use by the FDA 22 and not otherwise regulated by the U.S. Nuclear 23 Regulatory Commission". So, by definition, 24 radiopharmaceuticals are not hazardous drugs. I 25 acknowledge that they need to be understood, used NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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40 1 appropriately by trained individuals, but I just want 2 to point out that, by definition, they are not 3 hazardous drugs.
4 Thank you.
5 CHAIRMAN ALDERSON: Thank you for that 6 comment, Mr. Green.
7 Further comments?
8 (No response.)
9 So, I think we'll thank ASTRO for its 10 written statement and for its testimony.
11 And we'll go back to the operator and ask 12 if there are further comments that would like to be 13 made by the public.
14 OPERATOR: Dr. Carol Marcus, your line 15 is now open.
16 DR. MARCUS: Thank you very much, and we 17 would like to thank ACMUI for all its diligence in 18 this area.
19 I want to make two points, one of which 20 is the reason for the decreasing number of nuclear 21 medicine residents, and the other point is going to 22 be that I don't believe that the NRC is appropriately 23 enforcing this 700-hour requirement.
24 As to the reason for the decreasing 25 nuclear medicine residents, it's pretty obvious. NRC NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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41 1 is chopping up nuclear medicine into bits and pieces 2 and letting other people do it. Hospital 3 administrators, charged with saving money any way 4 they can in today's reimbursement myth, simply tell 5 those physicians who can be Authorized Users to do so 6 and use that as an excuse to get rid of the well-7 qualified nuclear medicine physicians.
8 So, the reason for nuclear medicine 9 physicians decreasing is simply that they can't get 10 jobs. Obviously, a smart, young physician is not 11 going to go into a field where he can't get a job, 12 because it's being chopped up and given away to 13 everybody else.
14 My second point has to do with the 700 15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />. I'm not going to argue whether 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> is 16 the ideal number. I think it's probably a good 17 number. But, having taught for close to 40 years 18 residents in nuclear medicine, in diagnostic 19 radiology, and in radiation oncology, I would like to 20 certainly challenge whether the diagnostic 21 radiologists are getting 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. And nobody ever 22 checks.
23 The four months' residency that they do 24 during their -- four months' rotation in nuclear 25 medicine that they do during their radiology NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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42 1 residency is exactly 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, assuming a 40-hour 2 week. And almost all of that is diagnostic nuclear 3 medicine and not therapy. I would probably doubt 4 that more than 10 or 20 percent of it would be devoted 5 to therapy.
6 And on top of that, they don't really do 7 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> total over the four months. When you 8 deduct vacation time and time left the next day after 9 doing general radiology night call, the time going to 10 radiology lectures and time covering for other 11 radiology residents who are sick or on maternity 12 leave, one is down to, say, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> in nuclear 13 medicine total. And so, the amount of time spent in 14 therapy is probably 1/10th of the required 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.
15 And there have been many complaints about 16 the quality of nuclear medicine therapy done by 17 diagnostic radiologists by patients, to the point 18 where an organization has been formed of thyroid 19 cancer survivors complaining to the NRC about the 20 quality of therapy that they're getting.
21 And I really think that that 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 22 should be checked, should be inspected, and made sure 23 that the residency programs have 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. Because 24 it doesn't make any sense to argue for hours and hours 25 about how many hours you need if the regulator isn't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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43 1 going to check to make sure that those hours of 2 training are being met.
3 Thank you.
4 CHAIRMAN ALDERSON: Would the ACMUI like 5 to comment on that issue? Any comments from the 6 ACMUI?
7 MEMBER METTER: This is Darlene Metter.
8 CHAIRMAN ALDERSON: Dr. Metter, please.
9 MEMBER METTER: So, I've been in academic 10 medicine for over 20 years and been a supervising 11 physician for nuclear medicine Fellows residents and 12 radiology residents. And I understand Dr. Marcus' 13 concern, but the ABR has an exam to assess the 14 competency, if they've learned the information. Now 15 everybody learns in a different way. Someone can 16 learn something in one hour and it takes someone else 17 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />. So, I think the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> is an appropriate 18 number, as you said, but I think what I see is that 19 you have certification boards that assess your 20 competency and the assessment of your knowledge and 21 experience and ability to translate that into, 22 quote/unquote, "scenarios in care".
23 CHAIRMAN ALDERSON: Other comments, 24 please, from anyone?
25 (No response.)
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44 1 Hearing none, thank you, Dr. Marcus.
2 I think that we're ready for any other 3 members of the public who would like to comment.
4 OPERATOR: We have Jeffry Siegel, and 5 your line is now open.
6 DR. SIEGEL: Hi, Dr. Alderson, members 7 of the ACMUI and NRC. Thank you for the opportunity.
8 All I want to do is make a couple of 9 comments. I don't want to make any recommendations.
10 I want to remind everybody, since you're 11 calling out 35.390 specifically and nothing else 12 right now, that it was predated by -- and you can't 13 be dyslexic for this -- 35.930, where all that was 14 needed was 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. So, during the revision of Part 15 35 in 2004, 390 came into being. And I don't want 16 to argue whether the 700 is correct or not, but if 17 you're not a Board-certified physician and decide to 18 go the alternate pathway, which you're allowed to do, 19 then this is for all four categories. Because if you 20 only want one category, namely, the oral sodium 21 iodide, you could go to 394, which was a carve out 22 for endocrinologists, who only need 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. So, 23 one would, then, have to decide, is there really a 24 difference in safety and protection between somebody 25 administering 200 hours of sodium iodide versus NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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45 1 somebody who's administering 100 microcuries of an 2 alpha emitter, as an example? So, there could be, 3 instead of arguing over the alternate pathway in 390, 4 additional carve outs for physicians who specifically 5 want to limit their practice, just like an 6 endocrinologist does, to a specific category of 7 therapy.
8 And I thank you for allowing me to bring 9 this up.
10 CHAIRMAN ALDERSON: Thank you. Thank 11 you, Dr. Siegel. That is a good point. I'm glad 12 that you made that point. It's not the first time 13 it's been made. In fact, some of the previous input 14 received by the ACMUI from specialty groups has been 15 specifically to that point, that they would like 16 another exception made regarding just the drug that 17 they are interested in.
18 And there has been concern about getting 19 into a situation where, for example, the ACMUI would 20 recommend -- recall that all the ACMUI does is advise 21 and recommend -- that we begin having these carveouts 22 for a whole group of individual drugs one after the 23 other. There's been some concern about that as an 24 approach. But that idea does exist because of the 25 I-131 carveout.
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46 1 Would anyone else like to comment on 2 this?
3 (No response.)
4 Anyone on the ACMUI who would like to 5 comment on this issue?
6 (No response.)
7 Well, thank you for the comment, Dr.
8 Siegel.
9 And we'll now go back to the operator and 10 see if there are other members of the public who would 11 like to comment.
12 OPERATOR: I have a Dr. Greenspan.
13 Your line is open.
14 DR. GREENSPAN: Thank you. This is Ben 15 Greenspan. I am the current President of the Society 16 of Nuclear Medicine and Molecular Imaging.
17 We submitted some comments, also, to the 18 ACMUI, and they're fairly similar to those of ASTRO.
19 We do think there should be a decrease in the number 20 of hours.
21 Now I will say that that number, again, 22 is somewhat nebulous. I know it requires 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> 23 of didactic work and 500 hours of clinical 24 experience. But I'm not sure that we can really tell 25 competency by number of hours. I think what we need NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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47 1 to do is make sure people really know what they're 2 doing, that they really are competent. And the best 3 way to do that is provide excellent training and 4 experience.
5 And to be honest, I don't think a 6 certification board is sufficient. In diagnostic 7 radiology, a lot of the residents watch from the back 8 of the room and watch three therapies, and they figure 9 they can go out and treat patients. And I don't 10 think that's sufficient. I think we need to have 11 better oversight of the training, and we need to have 12 an exam to confirm that these people really are 13 competent and know the basics of what they're doing, 14 especially the basic science of radiation biology, 15 radiation safety, and so on.
16 And I am planning to develop a task force 17 to look at the amount of the training and the 18 curriculum that should be required for all sorts of 19 therapies with various radionuclides. I think 20 there's going to be an explosion of these in the 21 future with all sorts of radiopharmaceuticals, with 22 lutetium-177, and a number of other isotopes, maybe 23 actinium-225, and who knows what else?
24 And I think we need to be prepared for 25 that. And so, like I said, I'm going to be starting NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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48 1 a task force to look at the curriculum that should be 2 required for all nuclear medicine physicians, and 3 potentially others, if they meet the appropriate 4 training and qualifications, to handle these kinds of 5 therapies in the future, because I think there's 6 going to be an explosion of these.
7 Thank you very much.
8 CHAIRMAN ALDERSON: Thank you, Dr.
9 Greenspan.
10 Comments from the ACMUI about Dr.
11 Greenspan's position?
12 VICE CHAIRMAN ZANZONICO: This is Pat 13 Zanzonico.
14 I'd like to agree. I think, as has been 15 pointed out a number of times, the current training 16 and experience requirements were drafted over a 17 decade ago, and we all recognize and appreciate that 18 there's been major changes in the clinical use of 19 radionuclides with increasing targeted radionuclide 20 therapies and now the use of, and likely increasing 21 use of, alpha emitters. So, while training may or 22 may not have been adequate when originally drafted, 23 it certainly needs to be revisited and critically 24 reevaluated in light of these ongoing advances and 25 refinements in the field.
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49 1 CHAIRMAN ALDERSON: Thank you, Dr.
2 Zanzonico.
3 Would others like to comment?
4 MEMBER PALESTRO: Yes. This is Dr.
5 Palestro again.
6 I certainly agree with Dr. Greenspan's 7 comments about an examination, and so forth. And 8 again, I'm just going to continue to reemphasize 9 that, as we move forward, the Subcommittee and the 10 ACMUI, and even the NRC, really need to focus on the 11 educational components necessary to turn out 12 qualified individuals, and then, eventually, if 13 necessary, come up with hours. But you can't come 14 up with hours -- it's putting the cart before the 15 horse. We really need to define what is necessary 16 to turn out or to develop competent individuals, and 17 then, if necessary, sort of back the hours into it.
18 CHAIRMAN ALDERSON: Well, whether or not 19 it's hours, I mean, all of us, any of us who have 20 been involved with any of the ABMS boards know that 21 the current thing for the last 15 years has been the 22 development of maintenance of competence and how that 23 is assessed. So, it's probably going to be something 24 more complex even than hours, although hours may be 25 a component of it. So, I think this is a very complex NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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50 1 issue and it's not getting any clearer as we move 2 forward. I compliment the NRC and ACMUI on being 3 engaged in this issue at this particular time, but I 4 think we're far from being finished with our 5 deliberations.
6 Are there other comments? Comments from 7 the public or -- I'm sorry -- I should say, first, 8 are there further comments on this particular 9 statement by Dr. Greenspan?
10 MR. OUHIB: This is Zoubir.
11 CHAIRMAN ALDERSON: Yes?
12 MR. OUHIB: Just a quick question. It's 13 regarding the examination component that you had 14 stated. Can you elaborate on that a little bit more?
15 DR. GREENSPAN: Not a lot. First, we 16 intend to develop the educational components 17 necessary, all the basic sciences and clinical 18 requirements, and so on. And then, from that, an 19 exam can be made up that would test the basic 20 requirements.
21 We are willing to draw up an exam. It's 22 not clear who is actually going to be administering 23 an exam like this, but the Society is willing to 24 consider that. But the first step is to develop a 25 curriculum that would handle all these therapies in NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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51 1 the future, and particularly, there may be 2 combinations of alpha and beta emitters being given 3 either simultaneously or consecutively for patients 4 that may benefit them. And so, clinicians need to 5 understand all this.
6 So, I'm sorry I can't give you more of an 7 answer on the examination at this point. We'll have 8 to wait and see how things develop.
9 CHAIRMAN ALDERSON: All right. Thank 10 you. Thank you, Dr. Greenspan.
11 Other comments or questions for Dr.
12 Greenspan?
13 (No response.)
14 Hearing none, to the operator, do we have 15 other public comments?
16 OPERATOR: Next we have Michael Peters.
17 Michael Peters, your line is open.
18 MR. PETERS: Hi. This is Mike Peters 19 with the American College of Radiology.
20 Just a quick comment. So, the latest 21 Subcommittee recommendations pertaining to 390 raise 22 some interesting concepts for contemplation. I might 23 suggest soliciting written comments from the public 24 by publishing a formal Request for Information. You 25 could even include targeted questions for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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52 1 stakeholders developed by this Subcommittee together 2 with staff. Just some food for thought.
3 CHAIRMAN ALDERSON: Thank you, Mr.
4 Peters.
5 Comments or questions for Mr. Peters?
6 (No response.)
7 Thank you.
8 Hearing none, Operator, further 9 comments?
10 OPERATOR: We have Michael Guastella.
11 Your line is open.
12 MR. GUASTELLA: Thank you. Good 13 afternoon. This is Michael Guastella from the 14 Council on Radionuclides and Radiopharmaceuticals.
15 And I'd like to take the opportunity this 16 afternoon to reiterate --
17 CHAIRMAN ALDERSON: You'll have to stay 18 closer to your phone, please. Volume up.
19 MR. GUASTELLA: Is that better?
20 CHAIRMAN ALDERSON: Much better.
21 MR. GUASTELLA: Fantastic. Thank you.
22 I just wanted to reiterate some comments 23 that CORAR has offered the ACMUI on this topic in the 24 past. CORAR does support an alternative pathway and 25 an alternative to the current 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. We have NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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53 1 recommended a specific scope of training requirements 2 for radioisotope handling and radiation safety for 3 physicians that are wishing to administer intravenous 4 therapeutic radiopharmaceuticals containing alpha-5 and beta-emitting radioisotopes, which -- and this is 6 important -- which have been prepared by a licensed 7 nuclear pharmacist in a state-licensed radiopharmacy 8 and dispensed to physicians as patient-ready doses.
9 In determining the appropriate amount of 10 time and scope of content for radioisotope handling 11 and radiation safety training the physicians must 12 have, and physicians such as medical oncologists and 13 hematologists -- we haven't heard too much about 14 these specialties today in the call -- they should 15 receive the amount of training that will enable them 16 to safely administer these types of therapeutic 17 drugs.
18 And we've offered some of the following 19 factors to the ACMUI to consider, such as: the 20 limited role in handling these radiolabeled 21 therapeutic drugs, which, again, would be dispensed 22 and delivered to them in patient-ready doses from a 23 licensed radiopharmacy; the radiological safety 24 profiles of radiopharmaceuticals containing alpha-25 and beta-emitting isotopes, and, finally, physicians NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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54 1 experienced and trained handling toxic non-2 radioactive chemical therapies, such as cytotoxic 3 chemotherapy agents.
4 Thank you.
5 CHAIRMAN ALDERSON: You're welcome.
6 Comments? Any comments regarding what 7 was just said?
8 MR. GREEN: Dr. Alderson, this is Richard 9 Green.
10 CHAIRMAN ALDERSON: Yes, Richard, 11 please.
12 MR. GREEN: Mr. Guastella was bringing 13 up concepts that I know that some of the NRC 14 Commissioners have asked the NRC to evaluate, NRC 15 staff to evaluate. Does the concept of mode of 16 receipt have a role to play in the training and 17 experience requirements? These beta-, gamma-, and 18 alpha-emitting therapeutics -- and I agree with Dr.
19 Greenspan, I think that's where the growth in the 20 industry is going to be in these therapeutics -- do 21 not require formulation, a kit, compounding, do not 22 require imaging with a gamma camera or quality 23 control of a gamma camera.
24 So, I think it's important that we 25 evaluate not just the compounds and the 35.390, but NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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55 1 what is the manner of receipt? Because I think that 2 may also play into the T&E requirements.
3 Thank you.
4 CHAIRMAN ALDERSON: Thank you. Yes.
5 that is exactly what he was driving at.
6 Further comments on that issue?
7 (No response.)
8 Thank you.
9 Operator, are there further public 10 comments?
11 OPERATOR: Dr. Carol Marcus, your line 12 is open.
13 DR. MARCUS: Thank you very much.
14 I just wanted to make a comment about 15 some of the other outside commenters.
16 CHAIRMAN ALDERSON: Please.
17 DR. MARCUS: I was on the ACMUI from 1990 18 to 1994. And near the end of my term, when NRC was 19 contemplating redoing all the medical regulations, 20 which it did in 1997, the ACMUI made two unanimous 21 recommendations. One was to get rid of that two-week 22 80-hour endocrinology course for using I-131, which 23 is a throwback to the old days of the AEC right after 24 the Second World War. Because they did not feel that 25 two weeks of training was enough to learn the basic NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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56 1 radiation and nuclear sciences that you really needed 2 to know to handle I-131.
3 And the other recommendation that they 4 made unanimously was to have an exam in basic nuclear 5 and radiation sciences for anybody who wanted to 6 practice any kind of nuclear medicine. And this 7 requirement was actually in the first draft of the 8 regulations, but at the very end this appeared. NRC 9 reasoned that it would be too difficult to make a 10 different basic radiation and nuclear science exam 11 for each group of licensees. That was their excuse, 12 but we had in mind only one exam for any licensee.
13 And what we basically thought was that the NRC was 14 afraid that the people it was selling licenses to 15 wouldn't be able to pass the exam and they would lose 16 a lot of user fee money, and they need that user fee 17 money to support their staff.
18 This is always something that should be 19 kept in mind that NRC has to raise user fees to 20 support its regulatory program. And anything that 21 decreases the number of users is a threat to its 22 staff.
23 But the idea of the exam that Dr.
24 Greenspan talked about was a unanimous recommendation 25 of the ACMUI around 1994.
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57 1 Thank you.
2 CHAIRMAN ALDERSON: Thank you, Dr.
3 Marcus.
4 Would anyone like to comment on this 5 comment by Dr. Marcus?
6 (No response.)
7 Well, I think the fact that these issues 8 existed 20 years ago, and they still exist in 9 different context today, speaks to their complexity.
10 Would anyone like to make a comment?
11 VICE CHAIRMAN ZANZONICO: This is Pat 12 Zanzonico.
13 The notion that Dr. Marcus just raised of 14 a single competency exam or competency metric, even 15 if it weren't an exam, for all users I think is a 16 compelling one because the implication would be, if 17 prospective AUs did not take the same exam, what is 18 it that they did not need to know that was covered in 19 the exam, the compartmentalized exam they did take 20 versus another subspecialist may take? I think 21 that's a challenging question to answer. I mean, I 22 think there is a knowledge base and a competency base 23 that all physicians who work with radioactive 24 materials, regardless of the specific application 25 they are involved in, need to know. And if one starts NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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58 1 parsing the metrics of competency, whether by 2 different exams, and so forth, it does beg the 3 question, what is it that one physician who uses 4 radioactive material does not need to know to use 5 those materials safely and effectively?
6 CHAIRMAN ALDERSON: Thank you, Dr.
7 Zanzonico.
8 Would others like to comment?
9 MR. OUHIB: Yes. This is Zoubir.
10 I'm not really sure whether my statement 11 will be fair. But, if you have an individual, an 12 Authorized User, who specializes in one particular 13 element, wouldn't that provide less choices to 14 patient care in comparison to somebody who is 15 qualified and competent in providing all the others, 16 for that matter? It is just a thought.
17 CHAIRMAN ALDERSON: Right. It's a 18 difficult part of the problem.
19 Other comments?
20 VICE CHAIRMAN ZANZONICO: Well, just a 21 follow-up to that last comment. This is Pat 22 Zanzonico again.
23 CHAIRMAN ALDERSON: Yes, sure, Pat.
24 VICE CHAIRMAN ZANZONICO: Certainly I 25 agree there may be differences in details of what NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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59 1 particular physicians specializing in certain 2 applications may need to know, and that's an arguable 3 point certainly. But my initial feeling is that 4 there's much more in common that clinical users of 5 radioactive materials need to know, regardless of 6 their specific application, than there is different 7 among those applications. But, again, I concede it's 8 an arguable point, or at least that's my initial 9 feeling.
10 CHAIRMAN ALDERSON: Thank you.
11 Further comments?
12 (No response.)
13 Hearing none, back to the operator for 14 the next public comment.
15 OPERATOR: We have Jeffry Siegel.
16 Your line is open.
17 DR. SIEGEL: Hi. Sorry. I'm sure 18 you're all aware of this, but I want to make sure you 19 are, so we're not at 390 again five years from now.
20 You all know that the categories of use are only two 21 oral and two parenteral. So, my question is, since 22 so many new agents are coming down the pike, what 23 happens if this new agent is not oral or parentally 24 administered?
25 Thanks very much.
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60 1 CHAIRMAN ALDERSON: Oh, excellent 2 question. Would someone on the ACMUI or the NRC like 3 or the FDA like to answer that question?
4 MEMBER PALESTRO: Dr. Alderson, it's not 5 Dr. Palestro.
6 CHAIRMAN ALDERSON: Yes?
7 MEMBER PALESTRO: The Subcommittee that 8 is charged with reviewing the training and experience 9 requirements was established specifically to conduct 10 ongoing reviews in order to minimize the likelihood 11 of falling out of step with the times. So that, as 12 new agents become available, the Subcommittee would 13 review them, or potentially available, if we know 14 they're in the pipeline, review them and develop 15 recommendations about what, if any, additional 16 training would be required or perhaps a modification 17 in the current rules.
18 DR. SIEGEL: Right. Is my line still 19 open?
20 CHAIRMAN ALDERSON: Is this Dr. Siegel?
21 DR. SIEGEL: Yes.
22 CHAIRMAN ALDERSON: Yes, we can still 23 hear you.
24 DR. SIEGEL: Oh, okay, great. Yes.
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61 1 there's no carve out or there's no way in 390 that 2 one could even consider a different route of 3 administration. You have to go through 1,000 and 4 argue again what training and experience was 5 necessary for this new form of administration. So, 6 all I'm saying is maybe you want to not categorize 7 these four categories the way you have. And this is 8 an NRC question, I suspect.
9 MS. HOLIDAY: Dr. Alderson, this is 10 Sophie, if I may?
11 CHAIRMAN ALDERSON: Please.
12 MS. HOLIDAY: So, Dr. Siegel is asking 13 what happens if a radiopharmaceutical is neither oral 14 or parenteral, but, in actuality, parenteral 15 administration simply means that it's anything other 16 than oral administration.
17 CHAIRMAN ALDERSON: That's the way that 18 the NRC has defined that?
19 MS. HOLIDAY: Correct.
20 CHAIRMAN ALDERSON: Okay.
21 MS. HOLIDAY: And I actually looked up 22 the definition, and the definition for "parenteral" 23 is "administered or occurring elsewhere in the body, 24 then the mouth and alimentary canal".
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62 1 representative from the FDA with us. Is that 2 consistent with what the FDA thinks?
3 MEMBER O'HARA: Yes, it is. I also can't 4 say anything about any new form of delivery that may 5 be being looked at by the FDA. It would be classified 6 as something that is being reviewed by the FDA right 7 now. So, I can't say anything, if there is something 8 like that coming down the pike.
9 CHAIRMAN ALDERSON: So, given what Ms.
10 Holiday has just said, and the agreement, or at least 11 general agreement, from the FDA, I'll just make an 12 example here to try to increase my own clarity on the 13 issue. So, we all understand the oral part. It's 14 the parenteral -- and that's how, generally, I was 15 taught to say that word, "parenteral -- so, 16 parenteral could be some sort of an intramuscular 17 injection. What about inhalation? Would 18 inhalation, if there was a drug that could be inhaled 19 and would go in through the lungs, would that be 20 considered parenteral?
21 MR. GREEN: Dr. Alderson?
22 CHAIRMAN ALDERSON: Yes?
23 MR. GREEN: As a pharmacist, I would have 24 to defer to, you know, that's a different route. And 25 I would also say that transdermal would be a different NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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63 1 route. It's not through the oral, you know, 2 alimentary canal down the mouth.
3 CHAIRMAN ALDERSON: Correct.
4 MR. GREEN: And it's not injected through 5 a layer of skin. But I would say that inhalation or 6 transdermal are other routes that are not encompassed 7 in today's regulatory status.
8 CHAIRMAN ALDERSON: So, you would not 9 believe, Mr. Green, that those would be considered 10 parenteral?
11 MR. GREEN: I would not classify them 12 that way.
13 CHAIRMAN ALDERSON: Oh. So, we aren't 14 going to resolve this discussion, but it just seems 15 that we have, between the regulators and people who 16 are really looking at these issues from other points 17 of view, that even this definition would come under 18 scrutiny. So, another example of the complexity of 19 the issue.
20 And so, Dr. Siegel, thank you for 21 bringing that issue up to us.
22 Further comments on this route-of-23 administration issue?
24 MEMBER PALESTRO: Dr. Alderson, it's Dr.
25 Palestro.
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64 1 CHAIRMAN ALDERSON: Yes?
2 MEMBER PALESTRO: Given the questions 3 that have arisen, as the Subcommittee and the ACMUI 4 and the NRC continue to move forward on the issues, 5 I think it would be extremely important for us to 6 receive clarification of any specific definition of 7 what "parenteral" means to the regulators, not 8 necessarily what is stated in Webster's dictionary, 9 but the definition according to the regulators.
10 CHAIRMAN ALDERSON: Yes, very good.
11 Very good. I think that's quite correct, and 12 hopefully, some of our people from the NRC and the 13 FDA can work with their groups on that particular 14 issue and let us know how they -- well, I think we 15 know how Sophie and the NRC feels. So, I guess we 16 have to know of the FDA. We thought it seemed to 17 agree, but Mr. Green said some other groups would 18 not. So, we have to find out what's really out there 19 and include that in future discussions.
20 MEMBER O'HARA: Dr. Alderson, I'll talk 21 to the people on the drug side for the actual 22 definition.
23 CHAIRMAN ALDERSON: Okay. That's good.
24 That's good, too. And we'll try to see if we can get 25 everyone to agree.
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65 1 All right. Thank you.
2 Any further comments on this route-of-3 administration issue?
4 (No response.)
5 Hearing none, is there another comment 6 from the public?
7 OPERATOR: There is no one else on the 8 phone queue.
9 CHAIRMAN ALDERSON: All right.
10 Operator, why don't you please ask for further 11 comments from the public? And we'll give people a 12 chance who haven't thus far gotten online.
13 OPERATOR: Again, if you would like to 14 ask a question, please press *1 from your phone, 15 unmute your line, and speak your name clearly when 16 prompted. If you would like to withdraw your 17 question, you can press *2.
18 One moment while we wait for any further 19 questions.
20 (Pause.)
21 One moment. I do have someone that 22 queued in. Just one moment, please.
23 (Pause.)
24 We have a question from David.
25 Your line is now open.
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66 1 MR. BURPEE: Thank you.
2 David Burpee with Bayer Pharmaceuticals.
3 I work for licensing customers to ultimately be able 4 to legally ship product to them.
5 So, I want to thank the Committee and 6 everyone involved. This is very, very important work 7 because on the street level that I work with for 8 finding Authorized Users and helping them to 9 appropriately be a part of it, there's many 10 difficulties. And several have been touched on in 11 your discussion.
12 There is a geographic distribution 13 problem. So, yes, there's plenty of Authorized Users 14 that can work with this, with these products in 15 Chicago, but in the Upper Peninsula of Michigan I 16 have several accounts that have been struggling to 17 have an Authorized User for over a year. And so, 18 that means these patients have to travel many hours 19 managing a great deal of pain. And so, this is a big 20 problem. And so, thank you again for this work.
21 It's vital.
22 The complexity that I'm hearing is what 23 I see every day, too, and the differences in what is 24 required to be an Authorized User. Jeff Siegel 25 brought up the 394. There's also 396, which is NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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67 1 specifically for brachytherapy and eBr2 REDOX 2 requiring 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, including 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />. And so, 3 it's a question about why the discrepancy of that 4 versus the 200 and the 390. But I do believe it 5 relates to the complexities of these isotopes that 6 are coming down the road.
7 So, a suggestion may be, for 8 determination perhaps of each isotope as to its 9 safety and how complex it is for handling and working 10 with, that there maybe be a baseline, like 396, and 11 then, as the complexity goes up -- so, for example, 12 comparing alpha at 100 microcuries of a typical dose 13 to the lutetium products around 200 millicuries, that 14 there would be different standards perhaps, maybe 15 under 1,000, that would work for the right training 16 and the competency. I like the comment one person 17 had about how do we determine competency for each of 18 these isotopes.
19 So, I hope those thoughts help, and 20 again, thank you for your important work.
21 CHAIRMAN ALDERSON: Thank you.
22 Comments from the ACMUI on this last 23 phone call?
24 MEMBER WEIL: This is Laura Weil. I 25 would like to comment.
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68 1 CHAIRMAN ALDERSON: Yes, Laura.
2 MEMBER WEIL: To the comment regarding 3 the raw number of Authorized Users, it does not 4 necessarily ensure patient access. The geographic 5 distribution of those Authorized Users has to be 6 taken into account.
7 Thank you.
8 CHAIRMAN ALDERSON: Yes. Good. Thank 9 you, Laura.
10 Further comments from the ACMUI?
11 MEMBER PALESTRO: Yes, Dr. Alderson, 12 this is Dr. Palestro.
13 Laura makes a very valid point. The 14 problem is you can't legislate geographic 15 distribution. And I don't know how that's overcome.
16 I think that's a completely separate issue.
17 CHAIRMAN ALDERSON: Thank you, Dr.
18 Palestro.
19 Further comments?
20 VICE CHAIRMAN ZANZONICO: This is Pat 21 Zanzonico.
22 I think we all certainly understand and 23 empathize with patients who really are put out to 24 undergo a specific procedure, a specific procedure of 25 any kind. And there are all kinds of medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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69 1 procedures from open heart surgery to whatever that 2 are only done in specialized centers, likewise, some 3 forms of cancer chemotherapy. And as unfair and as 4 onerous as it may be, those procedures are performed 5 only at centers where the practitioners are competent 6 to perform them.
7 And while accessibility should be a 8 consideration in using radiopharmaceuticals 9 clinically, certainly in therapy, in particular, it 10 just strikes me it can't be a decisive consideration, 11 just as it can't be a decisive consideration in who 12 can perform all sorts of very complex medical 13 procedures that often are available only at tertiary 14 care academic medical centers.
15 CHAIRMAN ALDERSON: Thank you, Dr.
16 Zanzonico, for reminding us of that reality.
17 Further comments?
18 MEMBER WEIL: This is Laura Weil again.
19 Just one further clarification.
20 I'm not suggesting that accessibility is 21 in any way a substitute for competence. But I think 22 when we try to make the argument that there's no need 23 to look for an alternate pathway because there are 24 plenty of Authorized Users already available, we have 25 to be careful how we use the word "available" because, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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70 1 then, it's a fallacy to say that every patient in the 2 United States has access to an Authorized User, where 3 there might be another way, if there's an alternate 4 pathway, there might be a way to have people in the 5 community who are perfectly competent and well-6 trained and able to offer those services to people in 7 different geographic locations.
8 CHAIRMAN ALDERSON: Thank you, Ms. Weil.
9 Further ACMUI comments?
10 (No response.)
11 Hearing none, we'll go back to the 12 operator and see if there are any more public 13 comments.
14 OPERATOR: I have Munir Ghesani.
15 Your line is open.
16 DR. GHESANI: Thank you. Thank you to 17 the Committee for giving the opportunity to speak.
18 And thank you, ACMUI Committee, for putting this 19 extensive work and coming up with the recommendations 20 and report.
21 For disclosure, I'm the Human Relations 22 Chair for SNMMI and I'm also a member of the American 23 Board of Nuclear Medicine. But these opinions -- and 24 we have formal comments submitted by SNMMI, and Ben 25 Greenspan already mentioned earlier. But I would NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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71 1 like to add a few more, actually, two big comments.
2 One of them is about the discussion that 3 we had about the geographic distribution and 4 availability of Authorized Users based on geographic 5 location. While that may be true in certain parts 6 of the country, you have to also, as was mentioned by 7 Pat Zanzonico, that he is going to look into the fact 8 that that's the nature of the healthcare setup. And 9 for the patients who are actually coming for this 10 kind of treatment, they may also need a more extensive 11 consult in post-treatment follow-up as well as 12 handling of any complications.
13 So, in many ways, it is given, when 14 you're looking at a very tertiary mode of treatment, 15 that the patients are actually expected, and often 16 willing, to look for the nearest alternative, which 17 may not be next door in many instances. And 18 practicing in New York, I see that many patients that 19 we see in our daily practice do actually come from 20 surrounding areas and travel quite extensively to 21 come to a major tertiary center for their care. So, 22 I think we should be careful in not looking at the 23 geographic availability of the Authorized Users in 24 isolation.
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72 1 that, based on the earlier discussions, I saw that 2 there's quite a bit of uncertainty about the extent 3 of Authorized Users and perceived shortage in the 4 future. And I think we have plenty on it. Now 5 anytime we think about preemptive, it's always a good 6 idea because that avoids any catastrophe or crisis 7 that may come up in the future. But, on the other 8 hand, acting preemptively on data that's not 9 sufficient, I don't see that could be justified, 10 especially since there were comments made from the 11 radiation oncology community about their availability 12 of Authorized Users that has not decreased in number.
13 As far as the ABNM is concerned, in fact, 14 I highly recommend that you look at the most recent 15 data where not only the drop that occurred has now 16 plateaued out, but, in fact, there's actually a 17 slight, but certain, trend towards increased number 18 of diplomates. Now it's not dramatic increase to the 19 point that it meets the level that was seen in early 20 2000, but, nonetheless, it is an encouraging sign, 21 not to mention that there is actually a second pool 22 of residents who many of them -- as you know, the 23 American Board of Radiology has created this 24 alternate pathway, which ABNM has also supported, and 25 that's available. So that there is an increasing NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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73 1 number of residents actually looking at that path.
2 In fact, I was one of the first ones in the country 3 who started this pathway, and within my very first 4 year of offering it for residents, has stepped up.
5 And so, just to be careful about the 6 number of Authorized Users, about perceived shortage.
7 We do have another pool of residents from radiology 8 who are training for 12 months of their 16. You 9 know, they're training 16 months out of their four 10 years of radiology residency, and many of them are 11 offered an additional fellowship in nuclear FCT that 12 allows them to become more competent in delivering 13 these kinds of treatments.
14 And when you are talking about these 15 treatments, they are not given in isolation.
16 Oftentimes, there's a close correlation of imaging 17 study that needs to be done. And you have to be 18 very, very careful when you carve out a small section 19 that only those trained properly administer these 20 treatment. But the treatment is not given in 21 isolation. There's a good part of training, whether 22 it's in the nuclear medicine or in radiology that 23 actually involves not just the radiation safety, but 24 overall concepts of radiopharmacy physics as well as 25 overall concepts of imaging, and combining the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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74 1 imaging correlation with the treatment.
2 So, needless to say that it's very, very 3 premature, and I think it's not advisable, to look at 4 this treatment as something that happens in isolation 5 in the care of the patient. It has to be taken into 6 account a full spectrum of what goes on before you 7 decide to give a treatment, and many of those who are 8 in the audience right now know who are treating these 9 patients that imaging plays a crucial role before you 10 even think about administering the treatment, not to 11 mention that after administering that treatment, you 12 have to continuously follow these patients to make 13 sure in which direction your treatment is going.
14 So, I highly advise that this whole 15 concept of creating a new channel for treatment alone 16 is not a good and advisable concept.
17 CHAIRMAN ALDERSON: Thank you. Thank 18 you, Dr. Ghesani.
19 Comments on that?
20 MEMBER PALESTRO: Yes. This is Dr.
21 Palestro. I have a couple of comments.
22 No. 1, getting back to the geographic 23 distribution, the role of the Subcommittee and the 24 ACMUI is to ensure that the rules and regulations and 25 training and experience are sufficient that the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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75 1 individuals who will be using these various 2 radiopharmaceuticals are competent. We can't 3 control which ones they choose to use, nor is it 4 within our purview to do that. Similarly, it's not 5 within our purview to control shortages that may be 6 related to geographic distribution. We're simply 7 there to ensure competence in these individuals and 8 to ensure that our rules and regulations are not 9 limiting access or keeping the numbers of individuals 10 trained artificially down.
11 In terms of the numbers for nuclear 12 medicine, you know what? I was on the American Board 13 of Nuclear Medicine for seven years. I was Chair.
14 I was on the ACGME Residency Review Committee for 15 seven years. I was Chair. And there have been 16 numerous various attempts at slowing the decreasing 17 trend or the trend in decreasing numbers of residents 18 and taking the board, and so forth, over that time.
19 And the long and the short of it is, they have not 20 met with very much success.
21 The new concept may or may not turn 22 things around. I don't know. But I think, rather 23 than sitting back and waiting to see what happens or 24 anticipating that things are going to get better, 25 when we've got 10 years of history that say they NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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76 1 haven't gotten better, is a mistake. And I think 2 that we do need to be proactive and begin evaluating 3 the future and see where we stand, to avoid any 4 potential calamities.
5 And as far as having an adequate number 6 of AUs at the present time, again, there's no basis 7 in fact for any of that. It's a hypothesis. It may 8 be an educated guess. But none of us can sit down 9 and say that, yes, there are sufficient number of AUs 10 with any degree of certainty.
11 And what, in fact, the Subcommittee said 12 a couple of years ago was that there was nothing to 13 suggest that the explanation for the decreasing use 14 of one particular agent was related to a shortage or 15 a lack of AUs. So, it's a little bit different.
16 DR. GHESANI: Is my line still open?
17 CHAIRMAN ALDERSON: Whoever you are -- we 18 don't know who you are, but your line is open. We 19 can hear you.
20 DR. GHESANI: Yes, this is Munir Ghesani.
21 Thank you, Dr. Palestro, for the detailed 22 explanation, and I fully respect your judgment and 23 your observation about the ABNM noticing the drop.
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77 1 of the Board. And we have acknowledged that the drop 2 has been there, but the most recent data is suggesting 3 that it has plateaued out. And as I indicated, the 4 most recent one for this year has been a slight 5 internal increase in the number of applicants.
6 And the other noticeable change that we 7 have observed, and it is very much out in the public, 8 is that amongst the increase, as well as overall, 9 there are an increasing number of candidates who are 10 dual-certified. So, the offer of the 16-month 11 pathway occurred in 2010. Of course, when you offer 12 a new track in a long residency program, it takes 13 four or five years to notice the difference. And so, 14 this would be the first few years that are showing a 15 little bit of change. And I think that if the trend 16 continues and if the dual pathway is offered at the 17 same rate and, hopefully, at the increasing 18 institutions, then you will clearly have the benefit 19 of having more potential Authorized Users going into 20 practice in the future.
21 With regards to your observation about 22 the insufficient number of Authorized Users, you 23 mentioned that the ACMUI -- in fact, I was on that 24 call, and it was very clear that at that time it was 25 noticed by the ACMUI Subcommittee that there was no NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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78 1 such issue with regards to geographic availability 2 and overall shortage of the Authorized Users.
3 So, if that's the case, and if we don't 4 have a handle on the total number of Authorized Users 5 now or going into the future, I still maintain my 6 position that it is a little bit premature to be 7 preemptive without having a complete knowledge of 8 data for analytics. In the business world, people 9 would always rely on the data before making any future 10 decisions. And I think the practice of medicine 11 should be no different in that regard.
12 CHAIRMAN ALDERSON: Thank you, Dr.
13 Ghesani.
14 Further comments?
15 MEMBER PALESTRO: Yes. This is Dr.
16 Palestro. I would just like to respond briefly to 17 Dr. Ghesani.
18 No. 1, in terms of preemptive, I don't 19 think it's preemptive. I think it's more being 20 proactive. It's not something that's going to occur 21 overnight. As Dr. Alderson indicated, this is a slow 22 process that takes a lot of work.
23 Getting back to your comment on business, 24 they won't act until they have the data, again, I 25 have 10 years of data for the ABNM that shows a NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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79 1 decreasing trend. And if I'm going to follow your 2 suggestion on the way business would act, I would be 3 acting on those 10 years of data before I would be 4 sitting back and waiting for something hopefully to 5 happen.
6 That's not to suggest that it's not going 7 to happen. I hope it does. My whole career is built 8 on nuclear medicine. There's nothing enjoyable about 9 watching the number of individuals training in 10 nuclear medicine decrease. But I do have 10 years 11 of data that suggests that the numbers -- in fact, it 12 doesn't suggest -- it confirms the numbers have 13 continually decreased. And those are the data that 14 I have in front of me. And I don't think -- I 15 personally don't want to wait four or five years to 16 see whether or not the trend has actually changed.
17 CHAIRMAN ALDERSON: Thank you, Mr.
18 Palestro.
19 DR. GHESANI: Yes, Dr. Palestro, your 20 point is very well-taken, and no doubt that this is 21 an observation. But, while we are making a decision, 22 it would be prudent to also see the most recent trends 23 that have occurred.
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80 1 more advisable to look at the most recent data and 2 revisit the idea about where the trend is going.
3 Because there's no question that the last 10 years 4 have shown the trend to be in that direction, but, 5 you know, the last couple of years have been somewhat 6 different. And that should be strongly taken into 7 account before putting it all together.
8 CHAIRMAN ALDERSON: Thank you. So, yes, 9 the number of diplomates in one particular board are 10 a component of the AU availability issue, but I would 11 hope that we can stay off the details of the work of 12 one particular board at this particular time. I 13 think we've heard good comments on that, and thanks 14 to all of you.
15 Are there other people online at this 16 time who would like to make a new comment?
17 OPERATOR: We have no one else in the 18 queue.
19 CHAIRMAN ALDERSON: No one is in the 20 queue.
21 Are there other comments from members of 22 the ACMUI?
23 MR. OUHIB: This is Zoubir.
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81 1 one, as the healthcare business is looking into 2 Centers of Excellence. And I really believe that 3 these procedures are not just a matter of injecting 4 a dose, or whatever. There's a comprehensive care 5 that actually takes place, and I think that we need 6 to keep that in mind. I fully understand that is not 7 the scope of this Committee. However, that needs to 8 be kept in mind.
9 CHAIRMAN ALDERSON: Thank you.
10 Further comments from the ACMUI?
11 (No response.)
12 Hearing none, and hearing that there are 13 no people online, I believe that we can turn this 14 back to Mr. Bollock and the NRC.
15 MR. BOLLOCK: Thank you, Dr. Alderson.
16 And I appreciate the time, and I 17 appreciate all the comments and the Subcommittee's 18 report, the discussion, and the public comments on 19 all these. It is a very complex topic, a lot of 20 different considerations in this area.
21 I just want to remind the Committee that 22 the staff has been tasked by the Commission to 23 evaluate whether it makes sense to establish tailored 24 training/experience requirements for different 25 categories of radiopharmaceuticals; how those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.
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82 1 categories should be determined, such as by risks 2 posed by groups of radionuclides or by delivery 3 method; what the appropriate senior requirements 4 would be for each category, and whether those 5 requirements should be based on hours of 6 training/experience or focused more on competency.
7 So, we owe that to the Commission at the end of the 8 summer.
9 We will be providing our Draft Evaluation 10 to the ACMUI probably in about two months, give or 11 take, when we've drafted it.
12 Again, this is the staff's, this is just 13 the staff evaluation. It is not the Commission's.
14 It's a draft. And we listened to all the comments 15 we've heard. I think there was a comment that 16 touched on almost every one of these categories I 17 just said. So, we do appreciate all of that and the 18 insights we've received, both by the ACMUI and the 19 public.
20 CHAIRMAN ALDERSON: Excellent. Thank 21 you.
22 Are there any other further issues to be 23 brought before the group today?
24 (No response.)
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83 1 to approve. I think this has been a broad-ranging 2 discussion, and there are, as Mr. Bollock indicated 3 just now, lots of open ends that need to be 4 assimilated and summarized, which will be the work of 5 the next several months.
6 Are there any other further comments 7 before we adjourn?
8 MS. HOLIDAY: Dr. Alderson, this is 9 Sophie again.
10 Just as I did during the last 11 teleconference call, I would like to thank the 12 Committee for their time on reviewing this topic and 13 discussing it, including members of the public who 14 also participated.
15 I'd also like to remind everybody that 16 the ACMUI will be holding its spring meeting here at 17 NRC Headquarters next Wednesday and Thursday. We 18 look forward to having all of you here at Headquarters 19 and participation via webinar.
20 Thank you.
21 CHAIRMAN ALDERSON: Okay. Thank you 22 very much.
23 I think, hearing no other comments, 24 unless there are any, I think we will stand adjourned.
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84 1 was adjourned.)
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Statement of The American Society for Radiation Oncology (ASTRO)
Before the Nuclear Regulatory Commissions Advisory Committee on the Medical Use of Isotopes March 1, 2018 Chairman Alderson, members of the ACMUI and NRC staff, thank you for allowing me to provide this statement on behalf of the American Society for Radiation Oncology (ASTRO) in response to the Subcommittee on Training and Experience for all Modalities report discussed today.
ASTRO is the largest radiation oncology society in the world, with more than 10,000 members who specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, biology and physics, the Society is dedicated to improving patient care through education, clinical practice, advancement of science and advocacy. ASTROs highest priority has always been ensuring patients receive the safest, most effective treatments.
As we stated in our October 7, 2016 statement to the ACMUI, we strongly oppose any reduction in the training and experience (T&E) requirements found in 10 CFR 35.390, Training for use of unsealed byproduct material for which a written directive is required. Under this section, the NRC requires an authorized user (AU) to be certified by a medical specialty board recognized by either the NRC or an agreement state, or has completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of T&E in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. ASTRO believes that these requirements are appropriate, protect the safety of patients, the public, and practitioners, and should not be changed. Radiopharmaceuticals are highly effective in treating cancer, but also potentially hazardous drugs with possible harmful effects to both the patient and the public if not used correctly and under the supervision of a highly trained physician.
The rigorous T&E requirements contribute to the excellent safety record of radiopharmaceuticals. We believe that it is important that the person administering the radiopharmaceutical is appropriately trained in the safe handling, exposure risks, and the management of side effects of radiation.
In its report, the Subcommittee expresses concerns with the decline in the number of nuclear medicine physicians sitting for the Certification Examination of the American Board of Nuclear Medicine. However, the Subcommittee does not discuss other AUs, including radiation oncologists. The American Board of Radiology (ABR) estimates that between 2007 and 2017, approximately 1,650 radiation oncologists have been certified by the ABR with an Authorized User Eligibility designation and may become Authorized Users. In addition, ASTRO estimates that there are approximately 2,200 radiation oncology facilities in the United States, which means aside from the nuclear medicine trained AUs nationwide, there are likely enough AUs just among the radiation oncologists. Indeed, ASTRO is not aware of a perceived shortage of radiation oncologists anywhere in the country. However, without being able to identify which AUs are licensed under 35.390 and 35.300, it is not possible to confirm whether there is an actual AU shortage, or just a perceived one. Additionally, ASTRO has not heard what would be an ideal number of AUs. ASTRO members are ready to care for patients needing any radiopharmaceutical.
In conclusion, for the reasons stated above, ASTRO opposes a reduction in the T&E requirements for 10 CFR 35.390 and looks forward to providing input to the Subcommittee as it continues its deliberations.
February 28, 2018 U.S. Nuclear Regulatory Commission (NRC) 11555 Rockville Pike Rockville, MD 20852 Washington, DC 20555-0001 Re: Training and Experience Requirements
Dear members of the ACMUI:
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) appreciates the opportunity to provide comments on the Subcommittees Draft Interim Report. SNMMIs more than 17,000 members set the standard for molecular imaging and nuclear medicine practice through the creation of clinical guidelines, sharing evidence-based medicine through journals and meetings, and leading advocacy on key issues that affect molecular imaging and therapy research and practice. SNMMI is pleased to offer comments on specific topics detailed below.
The Society of Nuclear Medicine and Molecular Imaging continues to believe that reducing the number of hours of training requirements to any less than 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> will significantly compromise the level of care for the patients receiving these treatments. We understand however that the ACMUI would appreciate a more detailed description of the training and experience that authorized users need. We will develop more detailed recommendations and expect to submit them to you in late June. We hope this will provide the subcommittee with enough time to consider our recommendations before the ACMUIs next meeting in the Fall.
As you are aware, clinical nuclear medicine practice requires not only deep fundamental knowledge of radiation biology and radiation safety but also of indications, contraindications and safety precautions of these treatments. In addition, the administering physician needs to be fully prepared to handle any minor or major radiation spills that may have patient and health personnel safety implications as well as major regulatory implications at the local, state and federal levels.
SNMMI appreciates the opportunity to comment on this report and looks forward to working with you as this process moves forward. As always, SNMMI is ready to discuss any of its comments or meet with NRC on the above issues. In this regard, please contact Caitlin Kubler, Senior Manager, Regulatory Affairs, by email at ckubler@snmmi.org or by phone at 703-326-1190.
Sincerely, Bennett S. Greenspan, MD, FACNM, FACR President, SNMMI
Carol S. Marcus, Ph.D., M.D.
1877 Comstock Avenue Los Angeles, CA 90025-5014
<csmarcus@ucla.edu>
Feb. 21, 2018 Advisory Committee on Medical Uses of Isotopes (ACMUI)
U.S. Nuclear regulatory Commission 11555 Rockville Pike Rockville, MD 20852 c/o Ms. Sophie Holiday, Sophie.Holiday@nrc.gov
Dear Ms. Holiday and Members of the ACMUI:
Thank you for the opportunity to comment on the subject of training and experience (T&E) requirements for physicians to practice nuclear medicine therapy. I shared some of my thoughts with Dr. Metter on March 30, 2017, and will repeat some of my points here for the record.
Let me begin with a theoretical story to make the point that licensing physicians to do bits and pieces of nuclear medicine is a huge mistake.
Let us imagine that Dr. Brown takes a two week course in how to perform appendectomies and then goes to his hospital administrator wanting practice privileges to perform appendectomies.
The hospital administrator agrees. Dr. White takes a two month course in how to perform hernia repairs, and asks the same hospital administrator for practice privileges to perform hernia repairs.
The hospital administrator agrees. Dr. Black takes a one month course in how to perform cholecystectomies, and asks the same hospital administrator for practice privileges to perform cholecystectomies. The hospital administrator agrees. Dr. Green takes a four month course in how to perform lumpectomies and mastectomies, and asks the same hospital administrator for practice privileges to perform lumpectomies and mastectomies. The hospital administrator agrees. Drs. Brown, White, Black, and Green are family practice physicians, and when any of their patients come in with need of any of these procedures, they recommend themselves or each other to perform them. There was a board certified general surgeon on staff, but as his bread and butter business began melting away, he left and went elsewhere to practice. One night there is a 1
terrible auto accident, and severely injured victims are brought to the hospital. There is no general surgeon available to help these patients, and they die. This is theoretical of course, because physicians are not given practice privileges to practice bits and pieces of general surgery. Generally speaking a physician must be board certified in general surgery to get practice privileges in general surgery. He/she may opt to specialize in breast surgery, or endocrine surgery, etc., but must be educated, trained, and experienced in all of general surgery. He/she may then opt to generally restrict his/her practice any way he/she wishes to do so.
This is generally the case with all medical specialties. One cannot become a cardiologist, endocrinologist, pulmonologist, infectious disease expert, nephrologist, etc. without first becoming a general internist. Medical education, training, and experience start out broadly, and then become subspecialized. This is true of all medical specialties except nuclear medicine, and to my knowledge, only in the United States. What happened in the United States to cause a balkanization of nuclear medicine?
Part of the story is historical, part is political, and part is economic. Nuclear medicine began in the United States in 1936 with the use of P-32 sodium phosphate to treat polycythemia rubra vera. Before WWII, radionuclides were accelerator produced and their medical use was not regulated by anyone except generally by State Boards of Medicine. After WWII ended, I-131 sodium iodide was produced in the Oak Ridge reactor and became available for treating hyperthyroidism and differentiated thyroid cancer. Due to the fact that there was no specialty called nuclear medicine, the fledgling Atomic Energy Commission ran a two week course in how to use I-131 sodium iodide to treat hyperthyroidism and differentiated thyroid cancer, and established an Advisory Committee on Medical Uses of Isotopes (ACMUI) to determine what radiopharmaceuticals could be used by physicians to diagnose and treat which conditions. At that time the FDA did not regulate radiopharmaceuticals (they didnt until 1975). When the Atomic Energy Commission was divided up into what became the Department of Energy (DOE) and the Nuclear Regulatory Commission (NRC), the ACMUI was retained by the NRC. When nuclear medicine finally became established as a board certifiable specialty, the NRC asked the ACMUI if NRC should restrict nuclear medicine licensure to physicians board certified in nuclear medicine. Due to the fact that there were many physicians practicing nuclear medicine who didnt take the early boards, the ACMUI decided against recommending a requirement for board certification in nuclear medicine in order to be licensed to practice it. As time went on, more and more board certified nuclear medicine physicians took positions in hospitals and in private practice.
The downturn in the building of nuclear power plants took place after the Three Mile Island accident in 1979, and the NRC looked to medicine to increase its regulatory activities. Then Congress put a User Fee provision into a law and the NRC had to raise its whole operating budget with User Fees, except for International Programs, which at the time was about 10% of its budget. The User Fee requirement stated that each class of NRC licensees had to take care of its own regulatory program. NRC could not use User Fees from the nuclear power side to fund its Medical Program, for example. NRC had hired many employees for its Medical Program, and its medical User Fees were high. The next year NRC tried to raise the fees even higher, and the 2
nuclear medicine community went to Congress and complained bitterly. The House Oversight Committee told NRC it could not raise its Medical User Fees.
The NRC was faced with two choices: lay off extraneous staff to keep the User Fees low, or sell more radioactive materials licenses in the medical sector to support its bureaucracy. It doesnt take a rocket scientist to figure out what happened. NRC started chopping up nuclear medicine into bits and pieces and selling more licenses. But the perfect storm occurred when Congress started putting the squeeze on hospital reimbursement. Hospital administrators were forced to cut costs wherever possible. So as cardiologists could be licensed to do nuclear cardiology, and diagnostic radiologists could be licensed to do diagnostic imaging and nuclear medicine therapy, and radiation oncologists could be licensed to do nuclear medicine therapy, the hospital administrators insisted that they do so and then laid off their board certified nuclear medicine physicians, or did not replace them when they left or retired. Today there are very few positions for board certified nuclear medicine physicians in the United States except for academic medicine. Most community hospitals will not take on a nuclear medicine physician unless he/she is also board certified in diagnostic radiology. Fewer medical school graduates choose nuclear medicine as a specialty, and nuclear medicine residency programs began decreasing.
While the field is in good shape, the specialty is dying. At present we are down to 42 residency programs in the United States, with a total of 69 residents, 72.5% of whom are foreign medical graduates (1). And because of all this, the quality of nuclear medicine is often poor. Many radiologists and cardiologists expect their technologists to practice nuclear medicine, even to the point of reading out the scans, and no technologist is capable of practicing nuclear medicine.
Many nuclear cardiologists contract out the reading of their scans to board certified nuclear medicine physicians, because the cardiologists are not competent to do so. The NRC, which purportedly increased its regulation of nuclear medicine to keep America safe, has been the driving force in decreasing the safety of American patients by imposing poor quality nuclear medicine practice on them. The patients are not endangered by the radiation in nuclear medicine. They are endangered because the studies are not optimally varied for individual patients with differing diagnostic questions, because the nuclear medicine physician does not even see the study until the end of the day when the tech has decided on the procedure and the patient is gone. The creativity in devising diagnostic nuclear medicine studies to get at difficult problems is gone. Many diagnostic procedures are misread or incompletely read. Most research and development in the United States is gone---just look at the Journal of Nuclear Medicine and see how most of the papers are coming in from other countries. Nuclear medicine technologist training programs run by nuclear medicine departments in hospitals are closing---the diagnostic radiologists have no interest or expertise to keep them going.
The situation with nuclear medicine therapy is even more problematic. Other than the use of Na I-131 to treat hyperthyroidism, all therapies at present are for cancer patients. Nuclear medicine therapies have side effects, sometimes moderate or severe, and many of the cancer patients are very ill, in pain, and have had prior treatments with chemotherapy, surgery, and/or radiation therapy. The patients and the patients families have many questions, and physicians with minimal education, training, and experience often cannot answer their questions. Many of these physicians dont even want to talk to their patients and tell their technologists to take care of it.
Technologists are unqualified to do so. A thyroid cancer survivor group apparently started by Peter Crane, a retired NRC lawyer, has complained to NRC about poor quality nuclear medicine 3
therapy care, expecting the NRC to fix the problem by regulation. Efforts by the NRC, with no medical competence whatsoever, to tell physicians how they must practice nuclear medicine are terrible. The problem is that these poorly competent physicians should not be practicing nuclear medicine therapy in the first place. My experience is that the worst group here is the diagnostic radiologists with no special training other than the supposed four month requirement for nuclear medicine during their diagnostic radiology residency. The radiation oncologists are generally somewhat better, but they usually have little training and experience as well. While theoretically each group receives 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, as promised by memos of understanding between their boards and the NRC, I think that it is highly unlikely that many of the residency programs for these groups actually offer such training, and that residents often do not attend many of the lectures and practice opportunities that are offered. To my knowledge, NRC has never inspected any of these programs to check whether residents actually receive 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training, and it might be a good idea for them to do so, and to check whether the residents actually come to the training offered. In January of 2018 Lu-177 Lutathera was approved by FDA for neuroendocrine tumors, and clinical trials are ongoing for Lu-177 prostate specific membrane antigen (for prostate cancer). These therapies can have significant side effects, and competent physicians must be present to take care of the patients. The problem of quality of the nuclear medicine therapy procedures may well worsen.
When I was on the ACMUI we unanimously voted to end the 80 hour9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> T&E program for endocrinologists to use any quantity of I-131 NaI for hyperthyroid and thyroid cancer therapy.
However, when NRC redid the medical regulations in 1997 it chose to ignore the ACMUI. In addition, the ACMUI unanimously voted to require a comprehensive examination in basic nuclear and radiation sciences for physicians who supposedly met the T&E requirements, to make certain that they actually internalized the needed information. The first draft of the 1997 regulations contained that requirement, but mysteriously disappeared in the final regulations with the lame excuse that making up a different examination for each group of nuclear medicine physicians was too difficult. The ACMUI never suggested a different examination for each group of physicians; only one examination was envisioned. However, it appears that the NRC realized that many of its authorized user physicians could not pass such an examination, and it would then lose the User Fees from these physicians, and that would mean laying off staff in the Medical Program.
It appears that some physicians in medical specialties that do not now have T&E programs for nuclear medical therapy are looking at profits from performing these therapies and want a limited T&E program like the endocrinologists have. Their excuse is patient access. I am absolutely opposed to this. It would only make the problem worse. There is no limit to how low medical quality can sink, and we do not need a regulatory agency that purports to improve safety to continue to lower medical quality.
So, what do we do to fix this T&E mess? The NRC needs to end the chopping up of nuclear medicine into multiple pieces and end the licensing of non-board certified nuclear medicine physicians for any of those pieces. This would restore a critical mass of procedures to a board-certified nuclear medicine physician, justifying a full-time person performing these procedures.
After all, in radiation oncology the NRC requires board-certification in radiation oncology to perform any procedures using byproduct material (brachytherapy and some large sources in 4
Gamma Knife type procedures and I suppose a few Co-60 machines, although these are mainly defunct now). Why require board certification in radiation oncology but not nuclear medicine?
Politics and money! The radiation oncology groups fought like cats when NRC was thinking about removing the requirement for board certification. Unfortunately, nuclear medicine has not yet mounted such a fight. That is not a reason to destroy the specialty of nuclear medicine.
The use of unsealed radioactive material for nuclear medicine therapy is likely more dangerous than the use of sealed byproduct sources in radiation oncology.
A change such as this will take some time, so that more residents enter nuclear medicine and are available to be hired, replacing the part-time practitioners taking bits and pieces of nuclear medicine today. This could probably be accomplished over a 5-10 year period. In every first world country, and even a third world country like India, all nuclear medicine is practiced by board-certified nuclear medicine physicians. The United States is an outlier. We really do not need the NRCs Medical Program. In 1995, when the National Academy of Sciences Institute of Medicine (NAS-IOM) studied NRCs Medical Program under contract with the NRC, the NAS-IOM determined that NRCs Medical Program (including radiation oncology as well as nuclear medicine) was so dysfunctional, and such a danger to patients, that it recommended that Congress remove NRCs statutory authority in all of medicine and medical research. The standard of medical practice is determined by the specialties of nuclear medicine and radiation oncology, not the NRC. We do not need the NRC Medical Program at all. A requirement that any or all of nuclear medicine be practiced by board-certified nuclear medicine physicians and a continuation of the requirement that any or all of radiation oncology be practiced by board-certified radiation oncologists would replace all of Part 35, including all the NRCs Medical Program staff. This needs to be accomplished by the NRC Commissioners, and perhaps the Congress. But, for the benefit of patients, it is high time that it was accomplished.
Thank you for your attention and consideration.
Sincerely, Carol S. Marcus, Ph.D., M.D.
Prof. of Molecular and Medical Pharmacology (Nuclear Medicine), of Radiation Oncology, and of Radiological Sciences (ret.), David Geffen School of Medicine at UCLA
References:
(1) Barzansky B and Etzel S: Medical schools in the United States. JAMA 318(23):2370, 2017.