Can we avoid another shut down of nuclear medicine?
June 19, 2012
By Wayne Webster
These days everything is spun into a crisis. It’s unfortunate in a time of 24-hour news cycles the best we can do is act like Chicken Little even when it comes to the shortage of diagnostic isotopes used in medical imaging. Maybe the sky is falling in nuclear medicine but a piece hasn’t hit me in the head just yet.
Resolving the shortage problem is reasonably straight forward. The science is well understood and due to the very nature of the production of isotopes we are limited in our choice of solutions. With the paths for resolution being few, it would appear we could move deliberately to an outcome that keeps an important diagnostic technology functioning without major interruptions for patients needing the service. What should we do?
They say in the newsroom that every good story starts with the facts. Here they are: each year in the United States 55,000 diagnostic imaging tests are done in nuclear medicine. Most of these use the isotope technetium-99m (Tc-99m). This radioisotope is produced from the decay of a parent isotope molybdenum- 99 (Moly-99). The parent isotope is produced by a nuclear reactor through a process called fission. The reactor producing the vast majority of the Moly-99 is in Canada, at Chalk River, over 50-years old and ready to be retired in 2016. Now you know the problem — sort of. Some say, the simple solution is to just find another reactor to produce the Moly-99 or build a new one. But in a world filled with conflict, politics and personal gain, the right solutions aren’t always the ones pursued.
As the largest user of Tc-99m labeled radiopharmaceuticals, the United States has been kicking the can down the road for decades when it comes to funding and developing its own supply of radioisotopes. As you can imagine, having your own supply means building a reactor or two and this isn’t looked on favorably by the demagogues in Washington — it’s not a topic that gets you votes in November.
In 2009 the Canadian reactor, commonly referred to as the National Research Universal (NRU) reactor, went offline for long overdue service. Suddenly, the world experienced a shortage of Moly-99. The Canadian government stepped in and forced the reactor back into service so as not to ruffle diplomatic feathers. The reactor ev entually went offline anyway to make necessary repairs and many wondered if it would return. During the shortage the demand for Moly-99 continued, and the marketplace learned to do with less and survive.
Nuclear cardiologists performing cardiac stress testing are the largest clinical group using Tc-99m labeled radiopharmaceuticals. In a normal, non-shortage situation, patients are scheduled for scans, the radiopharmaceutical is ordered from the local nuclear pharmacy and the tests are conducted as required. With the shortage of Moly-99, rationing was implemented. As the generators loaded with Moly-99 were parceled out from the available supply, diagnostic centers called in daily to determine if doses could be secured for the next day’s imaging. There’s no question patient scans were delayed a few days as supplies were metered out. It’s true the shortage caused inconvenience, but on the other hand, doctors learned how to scan with lower doses, thus spreading the available supply and lowering radiation exposure for patients and staff. They also became better at determining who was in critical need of a scan and who could wait.
As it became evident the NRU reactor at Chalk River in Canada was shutting down for good in 2016, plans were launched at various agencies in the supply chain to solve the problem. The companies that make the Tc-99m generators expanded their programs to develop other suppliers around the world and they looked for companies with technology that might help.
The Canadians were the first to offer grants to researchers investigating other ways to make Moly-99 without a reactor. In the U.S., the DOE and the National Nuclear Security Administration’s (NNSA) Global Threat Reduction Initiative (GTRI) announced that together they were providing about $25 million in grants to several companies. They did this in hopes the companies could find a way to make Moly-99 without a reactor, thereby eliminating the need for the highly enriched uranium (HEU) used in reactors. This could reduce the potential of HEU falling into terrorist hands for the production of a weapon of mass destruction.
The problem with HEU and the associated terrorist bomb threat was inserted into the Moly-99 production process and it is now driving the development and the grants but not the science. When you read the literature of companies like Shine Medical Technologies and Northstar Medical Isotopes, what they talk about is developing a new and safer way to produce Moly-99. That new, safer way is with the use of accelerators like a linac or cyclotron. No reactor, no terrorists lurking around trying to grab some HEU from the reactor pool.
The NNSA and its GTRI initiative are working with blinders. HEU is everywhere there are reactors. In August 2011, the Nuclear Threat Initiative reported there are approximately 70 tons of HEU being used in civilian power and research reactor programs in over 30 countries. So inserting the requirement to produce Moly-99 without a reactor is folly when it is the best way to produce it and finding an alternative to reactor production of Molly-99 won’t reduce the terror threat. How about we reduce the terror threat by reducing the number of terrorists instead? But this is another discussion. My key point is that, so far, scientific evidence doesn’t support the claim that one can produce enough of the right Moly-99 to satisfy the need for nuclear medical diagnostic imaging. But because due to dangling grant money, there’s interest in finding another way.
GE Hitachi Nuclear Energy entered the field with the most practical solution. They proposed and developed a plan for using a power-generating reactor in Illinois for the production of Moly-99. The reactor and the fuel rods are there and will be for a very long time. So, why not use them? There was just one hitch — the cost of the Moly-99 coming out of the NRU reactor at Chalk River is cheap when compared to starting another reactor program. This resulted in the project being shelved because the economics aren’t attractive. The officials at GE Hitachi hold the technology and will most likely re-enter the market when they have fewer competitors and can charge a higher price.
Meanwhile, Shine and Northstar, both start-ups, received grants for developing a non-reactor path. The $25 million in grants are great for them, but the question is not whether the accelerator method will produce some material (it will), but whether the Moly-99 produced is hot enough to produce usable doses of Tc-99m so good imaging can be done. The jury’s still out, but it appears there are some very real obstacles in the processes being proposed.
Concurrently with the development of its accelerator-based technique for the production of Moly-99, North Star Medical Isotopes announced its plan to use the reactor at the University of Missouri, too. But the method they propose to use will not produce the hotter isotope. Yet the Missouri reactor is capable of preparing sufficient quantities of Moly-99 of the right grade for Tc-99m generator production just like the Canadian reactor. So the question becomes, why don’t they just do it?
The rumor in the marketplace is that a processing plant costing about $30 million is required to handle the Moly-99 produced by the reactor. The University of Missouri is unwilling to make the investment because of potential competing technologies and the possibility that the government or some other entity would compete with them, causing an increase in the inventory of Moly-99 and driving down the return on investment.
The government, through DOE and NNSA, has granted $25 million for developing ways to produce Moly-99 without a reactor. Had we committed this money to the University of Missouri and its reactor program for the purpose of establishing a processing plant, we’d have a practical solution before the 2016 shutdown of the Chalk River reactor. In addition, we’d be producing Moly-99 in the U.S. for use here and for export to others. But as I said earlier, in a world of conflict, politics and personal gain, solutions aren’t always obvious. It appears for nuclear medicine, Chicken Little may have been right.
About the author:
Wayne Webster founded Proactics Consulting in 2003 to provide executive coaching, business planning, and technology assessment support for users and sellers of diagnostic imaging equipment.
These days everything is spun into a crisis. It’s unfortunate in a time of 24-hour news cycles the best we can do is act like Chicken Little even when it comes to the shortage of diagnostic isotopes used in medical imaging. Maybe the sky is falling in nuclear medicine but a piece hasn’t hit me in the head just yet.
Resolving the shortage problem is reasonably straight forward. The science is well understood and due to the very nature of the production of isotopes we are limited in our choice of solutions. With the paths for resolution being few, it would appear we could move deliberately to an outcome that keeps an important diagnostic technology functioning without major interruptions for patients needing the service. What should we do?
They say in the newsroom that every good story starts with the facts. Here they are: each year in the United States 55,000 diagnostic imaging tests are done in nuclear medicine. Most of these use the isotope technetium-99m (Tc-99m). This radioisotope is produced from the decay of a parent isotope molybdenum- 99 (Moly-99). The parent isotope is produced by a nuclear reactor through a process called fission. The reactor producing the vast majority of the Moly-99 is in Canada, at Chalk River, over 50-years old and ready to be retired in 2016. Now you know the problem — sort of. Some say, the simple solution is to just find another reactor to produce the Moly-99 or build a new one. But in a world filled with conflict, politics and personal gain, the right solutions aren’t always the ones pursued.
As the largest user of Tc-99m labeled radiopharmaceuticals, the United States has been kicking the can down the road for decades when it comes to funding and developing its own supply of radioisotopes. As you can imagine, having your own supply means building a reactor or two and this isn’t looked on favorably by the demagogues in Washington — it’s not a topic that gets you votes in November.
In 2009 the Canadian reactor, commonly referred to as the National Research Universal (NRU) reactor, went offline for long overdue service. Suddenly, the world experienced a shortage of Moly-99. The Canadian government stepped in and forced the reactor back into service so as not to ruffle diplomatic feathers. The reactor ev entually went offline anyway to make necessary repairs and many wondered if it would return. During the shortage the demand for Moly-99 continued, and the marketplace learned to do with less and survive.
Nuclear cardiologists performing cardiac stress testing are the largest clinical group using Tc-99m labeled radiopharmaceuticals. In a normal, non-shortage situation, patients are scheduled for scans, the radiopharmaceutical is ordered from the local nuclear pharmacy and the tests are conducted as required. With the shortage of Moly-99, rationing was implemented. As the generators loaded with Moly-99 were parceled out from the available supply, diagnostic centers called in daily to determine if doses could be secured for the next day’s imaging. There’s no question patient scans were delayed a few days as supplies were metered out. It’s true the shortage caused inconvenience, but on the other hand, doctors learned how to scan with lower doses, thus spreading the available supply and lowering radiation exposure for patients and staff. They also became better at determining who was in critical need of a scan and who could wait.
As it became evident the NRU reactor at Chalk River in Canada was shutting down for good in 2016, plans were launched at various agencies in the supply chain to solve the problem. The companies that make the Tc-99m generators expanded their programs to develop other suppliers around the world and they looked for companies with technology that might help.
The Canadians were the first to offer grants to researchers investigating other ways to make Moly-99 without a reactor. In the U.S., the DOE and the National Nuclear Security Administration’s (NNSA) Global Threat Reduction Initiative (GTRI) announced that together they were providing about $25 million in grants to several companies. They did this in hopes the companies could find a way to make Moly-99 without a reactor, thereby eliminating the need for the highly enriched uranium (HEU) used in reactors. This could reduce the potential of HEU falling into terrorist hands for the production of a weapon of mass destruction.
The problem with HEU and the associated terrorist bomb threat was inserted into the Moly-99 production process and it is now driving the development and the grants but not the science. When you read the literature of companies like Shine Medical Technologies and Northstar Medical Isotopes, what they talk about is developing a new and safer way to produce Moly-99. That new, safer way is with the use of accelerators like a linac or cyclotron. No reactor, no terrorists lurking around trying to grab some HEU from the reactor pool.
The NNSA and its GTRI initiative are working with blinders. HEU is everywhere there are reactors. In August 2011, the Nuclear Threat Initiative reported there are approximately 70 tons of HEU being used in civilian power and research reactor programs in over 30 countries. So inserting the requirement to produce Moly-99 without a reactor is folly when it is the best way to produce it and finding an alternative to reactor production of Molly-99 won’t reduce the terror threat. How about we reduce the terror threat by reducing the number of terrorists instead? But this is another discussion. My key point is that, so far, scientific evidence doesn’t support the claim that one can produce enough of the right Moly-99 to satisfy the need for nuclear medical diagnostic imaging. But because due to dangling grant money, there’s interest in finding another way.
GE Hitachi Nuclear Energy entered the field with the most practical solution. They proposed and developed a plan for using a power-generating reactor in Illinois for the production of Moly-99. The reactor and the fuel rods are there and will be for a very long time. So, why not use them? There was just one hitch — the cost of the Moly-99 coming out of the NRU reactor at Chalk River is cheap when compared to starting another reactor program. This resulted in the project being shelved because the economics aren’t attractive. The officials at GE Hitachi hold the technology and will most likely re-enter the market when they have fewer competitors and can charge a higher price.
Meanwhile, Shine and Northstar, both start-ups, received grants for developing a non-reactor path. The $25 million in grants are great for them, but the question is not whether the accelerator method will produce some material (it will), but whether the Moly-99 produced is hot enough to produce usable doses of Tc-99m so good imaging can be done. The jury’s still out, but it appears there are some very real obstacles in the processes being proposed.
Concurrently with the development of its accelerator-based technique for the production of Moly-99, North Star Medical Isotopes announced its plan to use the reactor at the University of Missouri, too. But the method they propose to use will not produce the hotter isotope. Yet the Missouri reactor is capable of preparing sufficient quantities of Moly-99 of the right grade for Tc-99m generator production just like the Canadian reactor. So the question becomes, why don’t they just do it?
The rumor in the marketplace is that a processing plant costing about $30 million is required to handle the Moly-99 produced by the reactor. The University of Missouri is unwilling to make the investment because of potential competing technologies and the possibility that the government or some other entity would compete with them, causing an increase in the inventory of Moly-99 and driving down the return on investment.
The government, through DOE and NNSA, has granted $25 million for developing ways to produce Moly-99 without a reactor. Had we committed this money to the University of Missouri and its reactor program for the purpose of establishing a processing plant, we’d have a practical solution before the 2016 shutdown of the Chalk River reactor. In addition, we’d be producing Moly-99 in the U.S. for use here and for export to others. But as I said earlier, in a world of conflict, politics and personal gain, solutions aren’t always obvious. It appears for nuclear medicine, Chicken Little may have been right.
About the author:
Wayne Webster founded Proactics Consulting in 2003 to provide executive coaching, business planning, and technology assessment support for users and sellers of diagnostic imaging equipment.