Published as a Think Tank contribution in the Winnipeg Free Press July 17, 2024
Medical isotopes produced by cyclotrons are injected into patients for positron emission tomography, or PET imaging. PET images are used to diagnose cancer, demonstrate how far the cancer has spread (which stage it is), assess how well patients respond to therapy, and to reveal if their cancer has come back later.
The medical cyclotron program at Winnipeg’s Health Sciences Centre recently failed two consecutive Health Canada inspections. Despite that, the CBC has reported that a Shared Health spokesperson maintains “there is no risk to Manitobans.”
I disagree.
Health Canada is responsible for ensuring that drugs, including cyclotron-produced medical isotopes, are safe for patients. The cyclotron program has failed five out of nine Health Canada inspections since 2013, most recently last year and again this year. This track record should not be taken lightly! For comparison, medical cyclotrons in Saskatoon’s Sylvia Fedoruk Canadian Centre for Nuclear Innovation and the Thunder Bay Regional Health Sciences Centre have passed all of their Health Canada inspections. They have no failures on record.
In Health Canada’s most recent inspection, in April, four areas of concern remained, down from nine from the 2023 inspection. Health Canada’s April report did not mince words to express its lack of confidence in the HSC cyclotron programs: “The validation of aseptic (free from disease-causing micro-organisms) processing was inadequate… The environmental standards were inadequate in order to minimize particular or microbial contamination of aseptic or clean areas… The operators’ aseptic practices were inadequate to maintain sterility.”
My definition of “the product is safe to inject into patients” includes Health Canada’s reassurance and confidence that the HSC’s medical isotope program has robust quality control measures to prevent product contamination. On the contrary, Health Canada has communicated its lack of confidence. To avoid being labelled an alarmist, let me say that if I had cancer and needed a PET scan, I would get it at HSC, as the benefits of the scan probably outweigh the risks related to Health Canada’s findings.
Still, the risks are real and should be kept as low as possible. HSC routinely gets cyclotron-produced medical isotopes from Saskatoon. As a stopgap (until the HSC problems are fixed) it could tap into this supply until Health Canada is satisfied with a followup inspection. This would reduce the number of PET scans but would be a reasonable option in the short term. With an alternative supply available, and given Health Canada’s concerns, I am surprised the HSC cyclotron program has not been suspended until it can pass Health Canada inspections.
Cancer patients, especially those undergoing treatment, may have compromised immune systems, which makes it harder for them to fight infections, especially blood infections or sepsis, a serious and potentially life-threatening condition.
It is somewhat reassuring that Shared Health has reported that no known cases of sepsis have been linked to HSC’s cyclotron medical isotope program, which suggests a low probability of product contamination.
However, Health Canada does not feel that the probability of contamination is low enough. It is also worth noting that Shared Health just released a memo to staff outlining all the work that is being done to address remaining deficiencies arising from the 2024 Health Canada inspection. After reading this memo, I am somewhat reassured that serious issues, such as aseptic procedures, are being taken seriously.
How did HSC get to this sorry state?
The HSC medical cyclotron program failed its first inspection in 2013. This could be attributed to the steep learning curve of becoming a regulated drug manufacturer (cyclotron-produced medical isotopes) and meeting good manufacturing practice standards. HSC then passed all of its inspections until 2017. A few years later, in 2019, the medical cyclotron program lost its dedicated PET radiochemist, who was responsible for quality assurance and good manufacturing practice protocols.
A string of failed inspections ensued thereafter starting in 2020. In the usual health bureaucratic fashion, replacing the cyclotron medical radiochemist was delayed as external consultants were hired to review the cyclotron program and other aspects of the department. It took approximately five years, and failing three Health Canada inspections, to hire a dedicated PET radiochemist with good manufacturing practice experience.
Shared Health leaders should not be surprised by this sad state of affairs. They delayed adequately resourcing and hiring key personnel for five years and have jeopardized the medical cyclotron program, their reputation and, most importantly, patient access to PET scans.
Comments