Conflicts found on nuclear medicine safety panel
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Federal advisers on nuclear medicine safety had conflicts of interest when they evaluated whether accidental injections of radioactive drugs used in medical imaging should be reported to authorities, according to a watchdog report.
Why it matters: The special inquiry found the Nuclear Regulatory Commission doesn't have a policy requiring conflict-of-interest reviews and therefore lacks controls to ensure compliance with federal ethics guidelines.
Context: The inquiry by the NRC inspector general focused on diagnostic "extravasations," or instances where a radioactive solution used to peer into a specific part of the body leaks around the injection site into a patient's surrounding tissue.
- The NRC as far back as 1980 considered whether the incidents were reportable medical events, the report stated.
- But in September 2021, agency advisers evaluating a petition requesting changes to medical isotope guidelines voted unanimously against requiring the measurement of absorbed doses to determine whether an accident should be reported.
- The request —which came from Lucerno Dynamics, a North Carolina maker of devices measuring radioactive drug uptake in patients — would have required reporting if an accidental injection led to a high, localized dose of radiation exceeding 50 rems.
- The NRC currently doesn't classify the incidents as events that must be reported.
What they found: Two NRC advisers had undisclosed relationships with the Society of Nuclear Medicine and Molecular Imaging, which opposed the reporting requirement and ran an active campaign opposing the petition, the report found.
- The inspector general didn't find anything suggesting that the advisers would have financially benefited from the decision, but added that "a reasonable person could have questioned each member's impartiality" and faulted NRC for not considering whether its integrity could be undercut.
In December 2022, the NRC proposed making nuclear medicine injection extravasations be reportable, but only if they require medical attention for suspected radiation injury.
- Critics oppose the subjective patient injury threshold for extravasations before reporting.
- The IG report recommended revising the advisory panel's bylaws to address conflicts.
What we're watching: A final rule is expected in September 2026, the report said.
- In Congress, a bipartisan House bill would require the NRC to mandate reporting of unintended irradiation.
