“The NRC has abdicated its role as a protection agency for patients. Its policy in the past and current rulemaking considerations have been overreaching the commission’s purview and defeat the very purpose of its existence, which is protecting public health and safety!”
So stated a recent editorial by Dr. Aria Razmaria and Dr. Jeremie Calais of the Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at UCLA, and Journal of Nuclear Medicine editor-in-chief Dr. Johannes Czernin. The opinion piece was presented as the views of the authors alone and not of any organizations they work with.
At issue is the push by the NRC to ease training requirements for authorized users, which would increase the number of people allowed to provide radionuclide therapy.
Why would the Nuclear Regulatory Commission (NRC) consider easing requirements? According to the authors it is due to “a presumed future shortage of authorized users,” stemming from the present alternate pathway requirements of 700 hours of training and experience – about 4 months of training.
The NRC has now asked for comments on the issue, with an ending deadline of January 29, 2019.
The authors asked, “who has an interest in further diluting requirements for practicing therapeutic nuclear medicine and theranostics? Here is a simple suggestion: follow the money.”
Pointing a finger at the radiopharmaceutical industry, they argued that the emerging potential of targeted radionuclide therapies will generate large revenue streams, and that more authorized users would likely mean more therapy and more money. “This is how markets work. This is not a bad thing as long as it does not compromise quality of care and patient safety," they wrote.
The money trail, argued the authors, leads to the NRC as well, which supports itself with user fees. “As a consequence,” they stated, “there is a direct incentive for the NRC to issue as many authorized user licenses as possible – this is, in our view, a perfect example of a conflict of interest that cannot be managed.”
The premise that there is a bottleneck created by present training requirements is, itself, not supported by data, they advised.
“Based on annually published American Board of Nuclear Medicine data and by conservative estimates, the current nuclear medicine workforce consists of approximately 1,200 board-certified nuclear medicine physicians across the United States. Based on projections of future needs in radionuclide therapies, approximately 150 new theranostic centers across the United States would be needed to deliver approximately 150,000–200,000 treatment cycles per year (assuming 4 cycles, per patient for up to 50,000 patients per year). Each of these sites would treat 1,000–1,250 patients per year or 5–7 patients per day. The current ABNM-certified workforce in the United States and the expected addition of new ABNM-certified physicians in the upcoming years of approximately 50–60 ABNM diplomates per year will easily meet this demand.”
The presumed shortage has also been disputed by the Advisory Committee on the Medical Uses of Isotopes July 5, 2018, report, noted the authors.
“It is absurd and grotesque to assume that this expertise can be acquired in 80 (2 weeks) or even 700 hours (4 months),” they argued. “This expert-level competency requires years of solid training. Would anyone send a family member to any treatment delivered by someone who had 2 weeks of training? Limited AU licenses would be akin to providing privileges to non-oncologists to administer cytotoxic chemotherapies or immunotherapies after a 2-week course or to a non-surgeon to perform complex laparoscopic surgery after 4 months of surgery training.”
The editorial does not represent the official position of the SNMMI.
In its July, 2018, comments on training, it stated, “The Society of Nuclear Medicine and Molecular Imaging (SNMMI), together with representatives from the American College of Nuclear Medicine (ACNM) and American Society of Radiation Oncology (ASTRO), formed an ad hoc committee to offer their collective recommendations for potential updates to the Nuclear Regulatory Commission’s requirements for those who wish to be authorized users of unsealed byproduct material.
“The group identified the basic and clinical knowledge and skills needed by individuals seeking authorized user status through the “alternate pathway” (those not board-certified in nuclear medicine radiation oncology and related fields). As previously reported, the Nuclear Regulatory Commission is evaluating the current training and experience requirements because some stakeholders claim the current requirement of 700 hours of training and experience is excessive.”