By Malika Siker, MD, Ross Zeitlin, MD, and Danielle Bitterman, MD
In June 2017, the ASTRO Board of Directors named diversity and inclusion a core value in its Strategic Plan. As diversity, equity and inclusion advocates, we are thrilled to see reaffirmation of these values and eager to participate in expanded initiatives. To highlight ASTRO work in this area, ASTRONews featured stories on diversity and inclusion in its 2018 issues. Margaret Barnes, MD, penned a thoughtful Letter to the Editor that expressed disappointment in the lack of inclusion of the lesbian, gay, bisexual, transgender and queer or questioning (LGBTQ+) community in these efforts and discussed a need for ASTRO to be intentional about considering LGBTQ+ voices as we advocate for diversity and inclusion. To Dr. Barnes and anyone else who has felt excluded by this omission, we emphatically agree with this suggestion and believe that addressing this issue will strengthen our field.
In 2017, the American Society of Clinical Oncology (ASCO) issued recommendations for reducing cancer disparities among sexual and gender minority (SGM) populations. This article defined known SGM cancer disparities and suggested ways to address these challenges. In addition to focusing on our SGM patients, we see a need to ensure that our SGM colleagues feel safe and included in our field. ASTRO’s Committee for Health Equity, Diversity and Inclusion (CHEDI) has been working behind the scenes on initiatives to advocate for SGM health equity from both a patient and provider perspective.
The 2019 ASTRO Annual Meeting showcased the results of collaborative efforts focused on elevating SGM equity in the field of radiation oncology during three educational sessions. All of these sessions were held on Tuesday, September 17, and were well attended with engaged audiences eager to learn more.
- The NCI/ASTRO Diversity Breakfast, held from 6:45 a.m. to 8:00 a.m., highlighted a panel on recruitment and retention of women and minorities in the radiation oncology workforce. Dr. Raymond Mailhot of the University of Florida was featured on this panel and discussed the additional obstacles he faced as a gay Latino man navigating medical education, the residency application trail and beyond. His story illustrated the courage and resiliency our SGM colleagues need to develop as they navigate their careers in an environment that has traditionally not been inclusive of SGM population issues. Our field and the care we provide to patients will be enriched by addressing barriers faced by LGBTQ+ individuals throughout their career to ensure they are supported in achieving their personal and professional aims.
- CHEDI sponsored a panel on the treatment of vulnerable communities in radiation oncology from 2:45 p.m. to 4:00 p.m. Dr. Ross Zeitlin of the Medical College of Wisconsin was included on this panel and examined cancer disparities in the SGM community with a specific focus on the impact these have in radiation oncology. His presentation included an evidence-based review of the current data, clinical challenges and future directions. Raising awareness and educating health care providers about SGM community cancer disparities is essential so we can improve health equity in this vulnerable community.
- From 4:45 p.m. to 6:00 p.m., a multi-institutional and multidisciplinary panel entitled “Is there a Standard of Practice in Oncologic Care for Transgender Patients?” featured Dr. Daphne Haas-Kogan, Dr. Anthony Zietman, Dr. Stephanie Terezakis, Paula Neira, MSN, RN, JD, Dr. Danielle Bitterman and Dr. Zackory Burns. During this session, they discussed fundamentals of transgender care, the need for workforce education, cultural sensitivity and legal issues in an engaging format. As radiation oncologists, we need to understand the best practices in caring for transgender patients to ensure we are meeting the needs of this population.
As a reminder, these sessions are available on the ASTRO Annual Meeting Virtual Meeting platform. If you attended the Annual Meeting, you have access to the Virtual Meeting; if not, the Virtual Meeting is available for purchase through the catalogue.
We are pleased to see that ASTRO and its members are interested in advocating for SGM health equity and inclusion through the events featured at the 2019 Annual Meeting and see a need to continue to build on these efforts. Recently, a new initiative for radiation oncology residents identifying as or allied with LGBTQ+ individuals was announced within the ARRO network. This initiative is in the building stages, and we are eager to extend an invitation to the radiation oncology community at large as we build this idea from the ground up. For further details, please email Dr. Ross Zeitlin.
With diversity and inclusion listed as a core value in ASTRO’s Strategic Plan, we know that these values remain part of the DNA of our organization, even starting with the first interaction one may have with ASTRO: the membership application. ASTRO recently updated the gender options on the membership application form to now include non-binary.
We must remain vigilant, transparent and responsive to the needs of our diverse members to ensure that all our colleagues feel included. Through CHEDI, ARRO and other collaborating groups, we must continue to work together to make sure we embody these values as an organization. Having a diverse and inclusive workforce ready to care for our diverse society will translate to improved health equity. We value our SGM patients and colleagues and will continue to advocate to ensure all voices are heard.
Malika Siker, MD, is an associate professor of radiation oncology and associate dean for Student Inclusion and Diversity at Medical College of Wisconsin in Milwaukee, Wisconsin. Her professional areas of interest include health equity, diversity and inclusion as well as hematologic and CNS malignancies.
Ross Zeitlin, MD, is a radiation oncology resident at the Medical College of Wisconsin. His academic interests include gynecologic malignancies and oncologic health disparities in the sexual and gender minorities.
Danielle Bitterman, MD, is a PGY-4 resident at the Harvard Radiation Oncology Program.
By Theodore DeWeese, MD, FASTRO, ASTRO Board Chair
On Wednesday, November 20, I met with Nuclear Regulatory Commission (NRC) Chairman Kristine Svinicki and commissioners Jeff Baran and Annie Caputo, as well as with NRC staff, to preserve strong training and experience (T&E) requirements for radiopharmaceuticals.
Over the past several years, in response to external pressure, the NRC staff has been reviewing the current requirements found in 10 CFR § 35.300 and 10 CFR § 35.390 to determine whether changes should be made. Part of this review has included outreach to stakeholders, including ASTRO, for their opinion and analysis of possible changes. As ASTRO chair, one of my priorities is to ensure that radiation oncologists play a leading role in the administration of radiopharmaceuticals. Fending off potential ill-advised changes to training and experience requirements will help achieve that goal.
Current regulations require that an authorized user (AU) be either board certified or complete 700 hours of training. The relevant sections of the regulations can be found here: Training for the use of unsealed byproduct material for which a written directive is required and Training for the parenteral administration of unsealed byproduct material requiring a written directive.
On the surface, reviewing current requirements to ensure their relevance is important and necessary. However, we are concerned that this review could initiate rulemaking to loosen the current 700-hour requirement – something that ASTRO, and partner organizations, oppose because the current requirements are appropriate, protect the safety of patients, the public, and practitioners, and should not be changed.
The NRC staff has concluded its review and is preparing a report to the commissioners. This report will outline policy options, as well as a recommendation for commission action. A version of the report was made public in October, so we were able to see the options the staff laid out; however, it did not include the staff’s final recommendation.
In the draft paper, the staff outlines two different approaches, each with several options, as follows:
Approach 1: Revise the T&E regulatory framework to remove prescriptive requirements, and the NRC and Agreement States would no longer review and approve T&E for AUs.
- Option 1a: Specialty Board Credentialing– Physicians must be certified by any medical specialty board.
- Option 1b: Licensee Credentialing– Licensees develop their own policies and procedures for credentialing their physicians.
- Option 1c: NRC-recognized Specialty Board Credentialing – Physicians must be certified by a medical specialty board that has been recognized by the NRC as meeting high-level board certification criteria.
Approach 2: Maintain or enhance the existing T&E regulatory framework.
- Option 2a: Status Quo– No changes.
- Option 2b: Tailored Requirements– T&E would be tailored and reduced for use of individual or categories of radiopharmaceuticals.
- Option 2c: Emerging Radiopharmaceuticals– Individual reviews of each emerging radiopharmaceutical to determine drug specific T&E and other requirements.
- Option 2d: Team-based Requirements– T&E would be reduced based on pairing AUs with other individuals with radiation safety training.
The staff paper also states: “The NRC regulates medical uses of byproduct material to ensure the safety of workers and the general public, and while patient access concerns were considered by the staff, the NRC cannot regulate T&E with a primary goal of increasing patient access to radiopharmaceuticals or improving geographic distribution of AUs.”
In response, the NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI), made the following ASTRO-supported recommendations:
- The Subcommittee recommends maintaining the status quo under 10 CFR § 35.390. While strongly affirming the structural superiority of the status quo over the other options proposed in the draft paper, we acknowledge there is room for a comprehensive review of the specific requirements in § 35.390 such as the seemingly arbitrary requirement of 700 hours. The Subcommittee (and likely, ACMUI) would welcome the opportunity to critically assess these details.
- If the NRC proceeds to grant AU status by NRC-recognized specialty boards, the T&E should be equivalent to § 35.390.
- The Subcommittee recognizes the value of an alternate pathway and is willing to review and evaluate the requisite knowledge, preceptor-reviewed experience and competency assessments.
ASTRO and I believe maintaining the status quo (Option 2a) for training and experience for radiopharmaceuticals is appropriate, protects the safety of patients, the public, and practitioners, and should not be changed. The NRC’s focus on patient safety and the safety of the general public as it develops training and experience requirements is appropriate. The classroom and clinical experiences encompassed by radiation oncology and nuclear medicine training programs provide appropriate levels of knowledge and skill for any current and future radioactive agents.
Reporting data also supports maintaining the status quo. While non-expert AUs would introduce significant radiation risks, radiopharmaceuticals — when administered under the supervision of comprehensively trained and experienced AUs — have an exemplary safety record, and the current regulations ensure that safety. In both 2017 and 2018, there was one event reported to the NRC using Ra-223. Between January 2014 and May 2019, only 16 out of 9,848 total events entered into RO-ILS: Radiation Oncology Incident Learning System® were related to radiopharmaceuticals. As indicated in the self-reported data, none of these events have been reported to either the NRC or an Agreement State.
Weakening AU T&E requirements would not create an influx of new licensed health care facilities providing these therapies in remote geographical areas. Rather, there are other considerations guiding facilities’ decisions, such as:
- availability/preference for alternative therapies,
- the high cost of these drugs,
- complexity of the patient cases, and
- financial and staff resources required (radiation safety officer services, technologists/therapists with appropriate licensure, license fees, etc.).
I was very pleased with the meetings, and I came away hopeful that ultimately the NRC will keep the status quo and will not initiate new rulemaking to lessen the current T&E requirements. ASTRO will keep up the pressure and continue reporting on developments.
ASTRO is interested in receiving your feedback regarding the T&E requirements for radiopharmaceuticals. Use the comments below to share your thoughts.