BULLETIN: The Department of Energy’s National Nuclear Security Administration has applied to the Nuclear Regulatory Commission for an amended export license to send apparently unanticipated additional shipments of high-enriched uranium to Europe to boost Molybdenum-99 production.
When we think of national and global security, we tend to think of terrorism, war, dirty bombs, airborne toxins and chemical attacks. But health care? Your cardiac stress test? A cancer scan?
To be sure, health care is a security issue in a broader sense, with implications for workforce integrity, skyrocketing medical costs and the consequences of untreated mental disorders. But it’s also directly related to the scarier things we worry about, like nuclear bombs. Here’s why.
One-quarter of hospital admissions in the United States receive nuclear medicine treatments, for example stress tests and cancer diagnostics. Globally, some 28 million of these procedures are performed a year, in 10,000 hospitals around the world. One of the most widely used nuclear medicines, Technetium-99m, is the agent of choice in stress tests and other procedures. Technetium-99m results from the radioactive decay of another isotope, Molybdenum-99, which is produced in nuclear reactors often called “research reactors.” Until recently, the reactors producing these isotopes use weapons-grade, 90% high-enriched uranium (HEU) as their fuel.
The international community has widely recognized the use of weapons-grade HEU to produce medical isotopes as a serious global security nonproliferation risk. Many non-nuclear weapons nations, such as (but not only) Iran, wish to have their own domestic capability to manufacture nuclear medicine. The US Government has responded through both congressional and executive branch action. Since 1992, there has been a legislative mandate in the US to reduce HEU use in isotope production. In 2004, the NNSA launched the Global Threat Reduction Program (GTRI). GTRI has made major strides toward securing and reducing the footprint of HEU worldwide.
A significant part of the effort to reduce the HEU proliferation risk in radiopharmaceuticals has been work to downgrade the nuclear fuel used in these reactors to low-enriched uranium (LEU), which is roughly 20% enriched. However, there are two major problems related to LEU. Most significantly, from a global security standpoint, LEU can be enriched relatively quickly to HEU given the right equipment. The second problem with LEU-produced isotopes is that their production appears to be less efficient and more costly than the HEU process.
An additional serious issue with the reactor-manufactured radiopharmaceuticals, whether they use HEU or LEU, is that the supply chain for Molybdenum-99 and its nuclear daughter, Technetium-99m, is very fragile. This is because the reactors making Molybdenum-99 are aging, in some cases leaking, and in need of costly and time-consuming repair. In fact, the US has not produced Molybdenum-99 since 1989, when the only domestic reactor making it was shut down because of radiation leaks. A handful of reactors in Canada, Belgium, the Netherlands, South Africa, and Ireland now make about 95% of the world’s supply of Molybdenum-99. When any one of them goes down for maintenance or repair, as has happened a few times in recent decades, world prices for nuclear medicine soar. Last month, a leak in South Africa’s research reactor caused it to be shut down, resulting immediately in a global radioisotope shortfall. Also in November, Canada’s Chalk River reactor – which makes about a third of the world’s supply of Molybdenum-99 – had to shut down temporarily. And last week, an article in Britain’s Nature magazine predicted more closures to come.
Thus, perhaps the goal of NNSA’s new shipment of HEU to Europe mentioned at the top of this essay is to prevent a looming crisis of supply and demand of Molybdenum-99, which would have serious impacts on medical care globally. Not only would this lead to higher medical costs across the board; it would also result in lengthy delays in diagnosis and treatment for patients with serious conditions. While such HEU shipments take place under contract, subject to strict licensing and under the most careful supervision and exhaustive security procedures, they do involve in effect an expansion of the proliferation of weapons-grade nuclear material. Such an action, despite an obvious immediate need, would seem to fly the face of national and international policy declarations to stem this important proliferation threat.
There is good news on the horizon, though, courtesy of basic scientific research. There is growing confidence that it is possible to produce effective radioisotopes – in some cases even more effective than those currently in use – without the use of nuclear reactors at all. We might call these, for lack of a better term, “NEU [no enriched uranium] isotopes.”
For many common medical procedures, including the extremely widespread cardiac stress test, it appears that NEU isotopes (for example, Rubidium-82) might be more effective and entail fewer diagnostic errors than with the popular Technetium-99m. In 2013, the US Congress authorized the NNSA to conduct research on the feasibility of other methods, primarily those involving nuclear accelerators that bombard targets with high-speed protons or electrons instead of nuclear reactors using enriched uranium. DOE’s Brookhaven and Los Alamos national laboratories are investigating these methods and the Canadian government is encouraging research in this area. This basic research is proceeding slowly but it appears encouraging.
However, the economics of bringing this new generation of NEU isotopes into use are daunting. A key problem, especially in the US, is regulatory. Very costly, cumbersome, and time-consuming Food and Drug Administration (FDA) rules stymie the innovative, for-profit companies (mostly small businesses) that would develop and market the products. Regulations, though, can also be agents of change. For example, in 2012, the Centers for Medicare and Medicaid Services (CMS) issued a rule imposing a $10 surcharge on nuclear medicine treatments with HEU-produced isotopes. While seemingly modest, given the number of procedures this measure creates a significant disincentive to the private sector to make or use these substances. Such regulatory action, motivated by clear national security concerns, is an interesting precedent that could accelerate the development of new, effective nuclear medicines in the NEU sector.
Another obstacle to switching to NEU radioisotopes may be reluctance on the part of the American medical community to move away from Technetium-99m, which has for decades been the workhorse in millions of procedures. Yet it is estimated that in terms of medical costs alone, there could be enormous savings by switching away from Technetium-99m, which has long been known to result in a significant proportion of erroneous diagnoses leading to costly, unnecessary and often dangerous medical interventions. Thus, NEU radioisotopes may be preferable in terms of the cost and quality of health care as well as of global security.
None of this will be inevitable or easy. Change in the US will require high-level pressure from the security community, perhaps starting with the National Security Council. A high-priority interagency task force can set out to tweak FDA and CMS regulations, among others, to streamline and reduce the cost of the obstacles confronting the private companies that see major market potential in putting NEU isotopes on the market. And Congress and the NNSA can take steps to increase funding to accelerate the basic research to validate the science underlying this key issue. Getting there will take time and resolve. It is time to start.
The author gratefully acknowledges the generous contributions and counsel of Dr. Stanley Satz.
__________________________________________________
Van Noorden, Richard. “The Medical Testing Crisis.” Nature 504 (12 December 2013): 202-204.
Photo credit: brykmantra via flickr
Why Your Stress Test Is a National Security Issue
By Gerson Sher
In Human Security & Governance
BULLETIN: The Department of Energy’s National Nuclear Security Administration has applied to the Nuclear Regulatory Commission for an amended export license to send apparently unanticipated additional shipments of high-enriched uranium to Europe to boost Molybdenum-99 production.
When we think of national and global security, we tend to think of terrorism, war, dirty bombs, airborne toxins and chemical attacks. But health care? Your cardiac stress test? A cancer scan?
To be sure, health care is a security issue in a broader sense, with implications for workforce integrity, skyrocketing medical costs and the consequences of untreated mental disorders. But it’s also directly related to the scarier things we worry about, like nuclear bombs. Here’s why.
One-quarter of hospital admissions in the United States receive nuclear medicine treatments, for example stress tests and cancer diagnostics. Globally, some 28 million of these procedures are performed a year, in 10,000 hospitals around the world. One of the most widely used nuclear medicines, Technetium-99m, is the agent of choice in stress tests and other procedures. Technetium-99m results from the radioactive decay of another isotope, Molybdenum-99, which is produced in nuclear reactors often called “research reactors.” Until recently, the reactors producing these isotopes use weapons-grade, 90% high-enriched uranium (HEU) as their fuel.
The international community has widely recognized the use of weapons-grade HEU to produce medical isotopes as a serious global security nonproliferation risk. Many non-nuclear weapons nations, such as (but not only) Iran, wish to have their own domestic capability to manufacture nuclear medicine. The US Government has responded through both congressional and executive branch action. Since 1992, there has been a legislative mandate in the US to reduce HEU use in isotope production. In 2004, the NNSA launched the Global Threat Reduction Program (GTRI). GTRI has made major strides toward securing and reducing the footprint of HEU worldwide.
A significant part of the effort to reduce the HEU proliferation risk in radiopharmaceuticals has been work to downgrade the nuclear fuel used in these reactors to low-enriched uranium (LEU), which is roughly 20% enriched. However, there are two major problems related to LEU. Most significantly, from a global security standpoint, LEU can be enriched relatively quickly to HEU given the right equipment. The second problem with LEU-produced isotopes is that their production appears to be less efficient and more costly than the HEU process.
An additional serious issue with the reactor-manufactured radiopharmaceuticals, whether they use HEU or LEU, is that the supply chain for Molybdenum-99 and its nuclear daughter, Technetium-99m, is very fragile. This is because the reactors making Molybdenum-99 are aging, in some cases leaking, and in need of costly and time-consuming repair. In fact, the US has not produced Molybdenum-99 since 1989, when the only domestic reactor making it was shut down because of radiation leaks. A handful of reactors in Canada, Belgium, the Netherlands, South Africa, and Ireland now make about 95% of the world’s supply of Molybdenum-99. When any one of them goes down for maintenance or repair, as has happened a few times in recent decades, world prices for nuclear medicine soar. Last month, a leak in South Africa’s research reactor caused it to be shut down, resulting immediately in a global radioisotope shortfall. Also in November, Canada’s Chalk River reactor – which makes about a third of the world’s supply of Molybdenum-99 – had to shut down temporarily. And last week, an article in Britain’s Nature magazine predicted more closures to come.
Thus, perhaps the goal of NNSA’s new shipment of HEU to Europe mentioned at the top of this essay is to prevent a looming crisis of supply and demand of Molybdenum-99, which would have serious impacts on medical care globally. Not only would this lead to higher medical costs across the board; it would also result in lengthy delays in diagnosis and treatment for patients with serious conditions. While such HEU shipments take place under contract, subject to strict licensing and under the most careful supervision and exhaustive security procedures, they do involve in effect an expansion of the proliferation of weapons-grade nuclear material. Such an action, despite an obvious immediate need, would seem to fly the face of national and international policy declarations to stem this important proliferation threat.
There is good news on the horizon, though, courtesy of basic scientific research. There is growing confidence that it is possible to produce effective radioisotopes – in some cases even more effective than those currently in use – without the use of nuclear reactors at all. We might call these, for lack of a better term, “NEU [no enriched uranium] isotopes.”
For many common medical procedures, including the extremely widespread cardiac stress test, it appears that NEU isotopes (for example, Rubidium-82) might be more effective and entail fewer diagnostic errors than with the popular Technetium-99m. In 2013, the US Congress authorized the NNSA to conduct research on the feasibility of other methods, primarily those involving nuclear accelerators that bombard targets with high-speed protons or electrons instead of nuclear reactors using enriched uranium. DOE’s Brookhaven and Los Alamos national laboratories are investigating these methods and the Canadian government is encouraging research in this area. This basic research is proceeding slowly but it appears encouraging.
However, the economics of bringing this new generation of NEU isotopes into use are daunting. A key problem, especially in the US, is regulatory. Very costly, cumbersome, and time-consuming Food and Drug Administration (FDA) rules stymie the innovative, for-profit companies (mostly small businesses) that would develop and market the products. Regulations, though, can also be agents of change. For example, in 2012, the Centers for Medicare and Medicaid Services (CMS) issued a rule imposing a $10 surcharge on nuclear medicine treatments with HEU-produced isotopes. While seemingly modest, given the number of procedures this measure creates a significant disincentive to the private sector to make or use these substances. Such regulatory action, motivated by clear national security concerns, is an interesting precedent that could accelerate the development of new, effective nuclear medicines in the NEU sector.
Another obstacle to switching to NEU radioisotopes may be reluctance on the part of the American medical community to move away from Technetium-99m, which has for decades been the workhorse in millions of procedures. Yet it is estimated that in terms of medical costs alone, there could be enormous savings by switching away from Technetium-99m, which has long been known to result in a significant proportion of erroneous diagnoses leading to costly, unnecessary and often dangerous medical interventions. Thus, NEU radioisotopes may be preferable in terms of the cost and quality of health care as well as of global security.
None of this will be inevitable or easy. Change in the US will require high-level pressure from the security community, perhaps starting with the National Security Council. A high-priority interagency task force can set out to tweak FDA and CMS regulations, among others, to streamline and reduce the cost of the obstacles confronting the private companies that see major market potential in putting NEU isotopes on the market. And Congress and the NNSA can take steps to increase funding to accelerate the basic research to validate the science underlying this key issue. Getting there will take time and resolve. It is time to start.
The author gratefully acknowledges the generous contributions and counsel of Dr. Stanley Satz.
__________________________________________________
Van Noorden, Richard. “The Medical Testing Crisis.” Nature 504 (12 December 2013): 202-204.
Photo credit: brykmantra via flickr