Patients support safe and transparent nuclear medicine

Simon Davies: ©Patients for Safer Nuclear Medicine Coalition

On behalf of Patients for Safer Nuclear Medicine (PSNM), a coalition of 30 patient advocacy groups, we object to the content of Cathy Sue Cutler’s column dismissing efforts to improve nuclear medicine safety and transparency.

At issue is a 44 year-old loophole in the Nuclear Regulatory Commission (NRC) “medical event” reporting rules.Since 1980, NRC has required reporting of events in which patients are unintentionally irradiated above a certain threshold, because these events may potentially indicate improper handling of radiation.The loophole exempts extravasations, when radiopharmaceuticals are accidentally injected into patients’ tissue instead of their vein as intended—even if the radiation dose dramatically exceeds NRC’s threshold.This results in a ridiculous situation: small spills of radiation on the patient that exceed the threshold are reportable, but large spills into the patient’s tissue are exempted.

After reviewing evidence that the loophole was incorrect, NRC accepted a petition for rulemaking on the issue. NRC then proposed a rule that would require, for the first time, reporting some nuclear medicine extravasations – those that cause harm or have the potential to cause harm.But asking the physicians opposed to reporting to use a subjective reporting criterion, instead of NRC's objective dose-based standard used for every other radiation safety event, fails to protect patients.

That is why a bipartisan group of legislators introduced the Nuclear Medicine Clarification Act (H.R. 6815).This sensible bill would require NRC to use the same objective reporting criterion that is used in every other aspect of radiation safety and provides a 14-month reporting grace period.If a patient is unintentionally irradiated above NRC’s threshold, it should be reported regardless of how it happened.

On the extravasation issue the Society for Nuclear Medicine and Molecular Imaging (SNMMI) has resisted commonsense safety and transparency for patients.In many major ways, Dr. Cutler’s column provides false, incomplete, or misleading information about the issue and legislation.

First, Dr. Cutler claims HR 6815 alters the regulatory process and would “transfer regulatory responsibilities” for nuclear medicine from NRC to Congress.This is intentionally obtuse or willfully dishonest.Nothing about HR 6815 assigns Congress as a regulator; the bill would merely close the exemption loophole, subjecting radiopharmaceutical administrations to the exact same safety and transparency requirements used in every other aspect of nuclear medicine radiation safety.Claiming that a bipartisan desire for basic patient safety requirements somehow “politicizes” the issue is nonsensical.

Second, Dr. Cutler claims that radiation doses are carefully managed and minimized. But provides no evidence for these claims.Congress needs to ask Dr. Cutler for scientific evidence. Patients appreciate therapeutic advances, personalized care, and special imaging cameras that save our lives. And we know that most injections are done properly, but we also have evidence that far too many are extravasated and large doses of radiation are accidentally injected into our tissue.These extravasations alter the procedural risk-benefit ratio and patients have a right to know.What Dr. Cutler fails to mention is that the SNMMI made a public comment a year ago that patients “need not be concerned” if their radiation dose for their diagnostic image is extravasated.And when asked by NRC to comment on assessing the radiation dose left in patients’ tissue, SNMMI ignored diagnostic extravasations.These comments make sense since SNMMI represents the interests of clinicians. But patients do need to know, and radiation doses need to be assessed for both radiation protection and procedural effects.That’s why the co-inventor of the positron emission tomography (PET) and computed tomography (CT) hybrid scanner, Dr. David Townsend, and many other unconflicted global experts, strongly advised the NRC to make large extravasations reportable.

Thirdly, Dr. Cutler invokes NRC’s Advisory Committee on Medical Use of Isotopes (ACMUI) as a model for using “rigorous scientific standards” to monitor and adapt regulations and claims the sole focus of ACMUI members is patient safety and effective care.Dr. Cutler fails to mention that many members are leaders in SNMMI.She also forgot to disclose that NRC’s Office of the Inspector General (OIG), issued a damning report in March 2024 identifying conflicts of interest affecting ACMUI’s advice on this issue.The investigative report specifically called out SNMMI for carrying out a lobbying campaign opposing additional reporting standards at the same time they participated in ACMUI deliberations on the petition.And to be fair, the NRC has also not lived up to the standard of using the latest evidence.That is why our coalition has sent the OIG five new evidence-based allegations that NRC management has failed to appropriately address a patient safety matter and why we support H.R. 6815.

Finally, Dr. Cutler’s piece would not be complete without invoking tried-and-true scare tactics intended to quash debate and make patients feel powerless.Patients reject the bizarre suggestion that that protecting our safety and ensuring transparency if an error happens will restrict access to procedures, jeopardize outcomes, or hamper innovation.

It is regrettable that SNMMI has refused to meet with us about this issue.Patients who need nuclear medicine services believe strongly that a commonsense requirement to report large unintended radiation doses into our bodies is not too much to ask.

Simon Davies is the Executive Director, Teen Cancer America, Patients for Safer Nuclear Medicine Coalition Spokesperson. Since its inception in 2013, Simon has led Teen Cancer America, the only national charity working directly with hospitals to advise, support and fund them in the development of specialized programs and facilities for adolescents and young adults with cancer. The charity is built on the successful model of Teenage Cancer Trust, UK where Simon was CEO for 13 years before moving to the US.

His early career was in the management of substantial social and health care services in the fields of Learning Disability and Mental Health. Awarded an honorary Doctorate in Education by University of Coventry for the advancement of AYA professional education, Simon has developed an international reputation for success in bringing about change within traditionally structured health systems.