SNM officials have issued a call for action to address the increasingly frequent shortages of essential medical isotopes while describing the damage done since the May 14 forced shutdown of the National Research Universal reactor at Chalk River, ON, Canada.
Speaking at the 2009 SNM meeting in Toronto, president Robert Atcher, Ph.D., announced a communiqué issued June 15 defining a six-point plan to eliminate disruptions in the supply of molybdenum-99. Mo-99 is a parent isotope for technetium-99m, an isotope consumed during more that 60% of nuclear imaging procedures.
The communique includes the following provisions:
• A call to U.S., Canadian, European, and other governments to build new isotope production facilities and update their old ones
• Support for the conversion from highly enriched uranium as the targets for Mo-99 manufacturing to less security-adverse low-enriched uranium
• An appeal to energy, healthcare, medical device, and pharmaceutical regulators to establish new reactors
• A request for more investment from isotope processors and distributors for programs that would stabilize isotope supply
Atcher characterized the NRU reactor shutdown as "one of the greatest threats" facing healthcare consumers.
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"(This is caused by) the lack of access to a reliable, consistent supply of the most important isotopes used in the effective detection and evaluation of patients with cancer, heart, and brain diseases as well as other disorders," he said.
During a press conference in Toronto, incoming SNM president Dr. Michael Graham said that he was unaware of any deaths from the current shortage, but he noted that diagnostic tests and therapeutic procedures have been delayed, and referring physicians have become increasingly frustrated.
"We are going to be seeing much more invasive tests, including exploratory surgeries, substituted for nuclear medicine," he said.
The SNM has learned from a survey of more than 1000 members that the NRU shortage has affected the ability of about nine of 10 nuclear imaging providers to practice nuclear medicine, he said.
According to Atcher, 16 million procedures are performed with Tc-99m annually in the U.S. Half of the isotopes originate from Chalk River.
The 45-MW research reactor was shut down in mid-May after a heavy water leak was detected. Atomic Energy Canada Ltd,, the semipublic corporation that owns and operates the reactor, announced the reactor and Mo-99 production will be suspended for at least three months.
This incident comes three months after the High Flex Reactor at Petten, the Netherlands, returned to action after a five-month safety-related shutdown. In combination, the Chalk River and Petten facilities are responsible for 70% of the global Mo-99 supply, Atcher said.
He is concerned about the possibility of an even more severe crisis because only five countries produce Mo-99 and the reactors that produce it are old. The typical useful life of a reactor is about 40 years, and average age of the reactors that manufacture Mo-99 is 47 years.
"It is clear that too many demands are being placed on too few facilities that are simply too old," he said. "We are very nervous."
The community could experience some relief from the planned start up of Mo-99 production at the Australian Nuclear Science and Technology Organization (ANSTO)'s Opal reactor. Deemed operational after uranium refueling in 2008, it would become the first reactor to use low-enriched uranium as a power source and as a target for Mo-99 production.
Lantheus Medical Imaging, a Tc-99 generator provider, announced an Mo-99 supply arrangement June 13 with ANSTO. Lantheus also recently announced a supply arrangement with a South African reactor company to diversify its Mo-99 sources.
Referring to the NRU reactor incident, Graham praised Canadian government officials for promptly disclosing news about the shutdown. He called on technetium suppliers Lantheus, GE Healthcare, and Covidien to publish weekly supply forecasts to help providers plan for anticipated shortages.
A month-long shutdown at the NRU reactor in 2007 led to contingency planning that has been implemented in Canada to address the current emergency, said N. Abrams, Ph.D., director of the Edmonton Radiopharmaceutical Centre.
Canadian providers have been encouraged to shift to F-18 FDG-PET when possible. Some facilities have shifted to radioactive fluoride for bone imaging and to thallium-201 for myocardial perfusion imaging. Cancer patients have been referred for MR and CT when appropriate.
HealthCanada, the coordinating agency for the country's provincial health plans, has adopted a fast review protocol to confirm the safety and efficacy of alternative radiopharmaceuticals. Discussions are under way between nuclear physicians and the Canadian Radiation Regulatory Society to liberalize licensing requirements for alternative isotopes. The Canadian Minister of Health has appointed former SNM president Dr. Alexander M. McEwan as a special advisor.
Discussions are under way about gearing up a research reactor at McMaster University in Hamilton, ON, to produce Mo-99. It would have the capacity to address about 10% of the world demand, according to Atcher, though at 10 times the cost per unit as isotopes produced at Chalk River.
In the U.S., the SNM has supported modifications to the University of Missouri Research Reactor (MURR). If fully funded, MURR could begin producing Mo-99 by the end of 2011, according to Atcher. A separate proposal by a collaboration between Covidien and Babcock & Wilcox, a nuclear reactor contractor, is five to seven years away from production.
