Robert Atcher,
outgoing SNM president,
speaks to DOTmed News
about trends and challenges
outgoing SNM president,
speaks to DOTmed News
about trends and challenges
SNM Outgoing President Robert Atcher Discusses Isotope Supply and Molecular Imaging
June 13, 2009
by Kathy Mahdoubi, Senior Correspondent
As the Society of Nuclear Medicine meets in Toronto, DOTmed News spoke to President Robert Atcher, PhD, MBA about the radioisotope shortage and new molecular imaging research before he passes the torch to president-elect Dr. Michael Graham.
[DM: What is the mission of SNM's annual meeting?]
R.A.: The annual meeting has really one primary focus and that is to ensure that our membership has the most up-to-date information relative to maintaining their certification to practice. This is true for the physicians, physicists, technologists, and the pharmacists. They all qualify for continuing education credit at our annual meeting. We also have scientific sessions, for which they get credit, but it's also for scientists like myself to talk about the latest advances that we've made. It's an educational symposium as well as a scientific exchange. And then of course we have a fairly substantial exhibit hall. It has attracted people from around the world, because it has the most extensive list of vendors in the field.
[DM: What is on top of the agenda at this year's meeting?]
R.A. We are experiencing a crisis because the radioisotopes that we use to formulate radiopharmaceuticals are in short supply. Ironically, the [National Research Universal] reactor in Canada is offline right now and they provide about 50 percent of the material that we use in the United States. That is the molybdenum-99 issue.
[DM: What are the proposed solutions to the radioisotope shortage?]
R.A. There's a lot of activity, but I don't know if there is anything to date that would qualify as a substantial solution. Many of the things that we're dealing with in terms of potential solutions are more than a year away. The reactor in Canada is proposed to be offline a minimum of three months. The [Petten] reactor in the Netherlands, which is responsible for producing another 50 percent of the U.S. market is proposed to be offline for a month in July for preventive maintenance and also to be out an extended period next year. We're really scrambling to figure out a way to solve this problem in the short term...The Netherlands' reactor may reschedule the July outage based on the fact that we don't have the Canadian reactor operating.
[DM: What steps are being taken to produce these radioisotopes in the U.S.?]
R.A. We've already sent a letter to Chairman Markey [of the Select Committee on Energy Independence and Global Warming] to say that we are very much in favor of a domestic supply solution. The one that seems to be the closest to potentially coming online is to expand the activity at the research reactor at the University of Missouri in Columbia Missouri to also include molybdenum-99 production.
[DM: Does the reactor in Missouri have the capacity to meet U.S. demand for molybdenum-99?]
R.A. It has the capacity to produce about 50 percent of the U.S. market, which, when we're looking at both of our major sources being offline potentially next year, that's certainly better than nothing. The other thing happening is that the Australians built a new reactor with a major mission of isotope production and they aren't quite yet online, but I anticipate it being so in a matter of weeks. They will be able to supply a percentage of the U.S. market -- not a huge percentage, but I think somewhere between 10 and 20 percent. At this point, any additional capacity we can bring online will certainly help.
[DM: What other reactors are available for the medical supply of radioisotopes?]
RA: There are five major reactors [producing medical radioisotopes]. There's the one in Canada, one in the Netherlands, Belgium, France and South Africa. The Australian reactor is coming online as we talked about. It's a new reactor that was completed a year or so ago. There are smaller production capabilities in Southeast Asia, Morocco, and another in Argentina, but those are really only equipped to supply the local market and aren't in a position to have a major impact on worldwide demand. There's a collaboration between Covidien, which is a major supplier of molybdenum to the United States, and Babcock & Wilcox, the engineering firm, to use an old reactor design, but it is actually very well suited to use as a production vehicle for molybdenum-99. That is probably five to seven years away from fruition.
[DM: What new product or procedural trends are you seeing in the molecular imaging community?]
RA: The shift to using positron emission tomography (PET) technology. It's a different radioactive decay process and it enables us to do pretty precise quantitation. It gives us an opportunity to look at differences before and after therapeutic intervention. This is where the real excitement is in terms of molecular imaging in the field of nuclear medicine. We're able to put cancer patients, for example, who have non-Hodgkin's lymphoma on therapeutic protocol and tell within a week or so whether it's working or not. We can potentially avoid having those patients who aren't responding well from going through an entire course of therapy at an additional expense and potentially additional toxicity to the patient.
The sale of instruments is also down pretty dramatically. There's a lot of nervousness after the Deficit Reduction Act of 2005 [in effect since 2007]. They focused on reimbursement for imaging and actually proposed cuts in the reimbursement. People doing imaging for a living have been a little more gun-shy about going out and buying new equipment. And then there is the issue of where we're going to be in a year or two if health care reform goes through. Are we going to be able to adequately charge for the services we provide?
Congress has made some proposals in terms of instrument utilization. Right now our utilization rate for the instruments we use in imaging are factored at about 45 percent of the time. Obviously there are times when a patient is getting on and off the machine. The proposal has been that we increase that rate to 90 percent. Eventually the expectation is that every single minute that the clinic is open, somebody should be actively imaged on that machine. People are going to be reimbursed a little less for each imaging procedure because the presumption is that it's being used more efficiently. The perception is that 45 percent is too low and they're trying to bring it up to somewhere in between. The number I've heard in meetings with other radiology societies is that we expect to come out around 75 percent utilization rate. It's still pushing it, but it's better than 90 percent.
In parallel there has been some concern on the part of the companies that make the pharmaceuticals, in particular the positron emitting radiopharmaceuticals. The concern is that we haven't penetrated enough into the field. Probably the most exciting developments have been in the area of oncologic imaging. Some of the new radiopharmaceuticals that are proposed might have some exciting impact on our ability to be even more precise than with radioactive glucose in assessing what's going on with patients.
There are also some pretty exciting compounds that are being developed for imaging and being able to actually diagnose patients who have Alzheimer's or other forms of dementia.
[DM: What other challenges are facing the molecular imaging community?]
RA: Particularly with the PET agents -- we are injecting such a small amount of material that the likelihood of seeing any kind of a pharmacologic or toxic effect on the patient is almost nil, but in the current environment, with the problems that we've had with the MRI contrast agents and some of the ultrasound agents and toxicity associated with those, trying to get the FDA to relax their stand in terms of extremely rigorous toxicity studies for radiopharmaceuticals is almost impossible. That's been one of our challenges, because it's so expensive now to develop new radiopharmaceuticals that you almost have to have the imaging equivalent of a home run.
[DM: Are there any issues with funding for nuclear medicine research?]
RA: In 2006 the Office of Management and Budget (OMB) eliminated the nuclear medicine research funding in the Department of Energy budget. It was very unfortunate, because that funding was involved in supporting some of the very basic science that we do at the interface of the physical sciences and the biologic sciences. We've lost a lot of funding for basic radiochemistry activity and funding for improved instrumentation and improved software to do image analysis. We then started to try to work with Congress and we were finally successful in 2008 in getting that funding restored -- it was only about half of what we had in 2005, but nonetheless it got us going again. The challenge has been that the Department of Energy has been trying to move the focus of that funding toward other bioscience activities. Congress has been willing to work with us to put specific language in the appropriations bills that defines the mission of that funding to be for nuclear medicine research. That was true in 2008 and 2009. Since we're in the appropriations process for 2010, we'll continue to work with Congress to make sure that the funding continues to be defined for use in nuclear medicine research. That's been a constant struggle for us.
The competition for funding for nuclear medicine research at the advanced stage, when we would be approaching NIH to support that activity, has been challenging. Inflation adjusted, that funding has been going down fairly dramatically...probably about 25 percent. With the change in administration, they're talking about increasing support for research funded by NIH. We are hoping that will actually come to pass. It's certainly going to be evident when we see the appropriations for the fiscal year 2010.
--
Related news about the 56th SNM annual meeting, the radiopharmaceutical shortage, and nuclear medicine:
Industry Sector Report: Nuclear Medicine, DOTmed Business News, June 2009, now online
2009 SNM Annual Meeting Preview
https://www.dotmed.com/news/story/9118/
Medical Isotope Shortage Reaching Crisis Proportions
https://www.dotmed.com/news/story/9325/
Serious Concerns as Isotope Shortage Looms
https://www.dotmed.com/news/story/6859/
Canada Stops Medical Isotope Reactor Project
https://www.dotmed.com/news/story/6026/
[DM: What is the mission of SNM's annual meeting?]
R.A.: The annual meeting has really one primary focus and that is to ensure that our membership has the most up-to-date information relative to maintaining their certification to practice. This is true for the physicians, physicists, technologists, and the pharmacists. They all qualify for continuing education credit at our annual meeting. We also have scientific sessions, for which they get credit, but it's also for scientists like myself to talk about the latest advances that we've made. It's an educational symposium as well as a scientific exchange. And then of course we have a fairly substantial exhibit hall. It has attracted people from around the world, because it has the most extensive list of vendors in the field.
[DM: What is on top of the agenda at this year's meeting?]
R.A. We are experiencing a crisis because the radioisotopes that we use to formulate radiopharmaceuticals are in short supply. Ironically, the [National Research Universal] reactor in Canada is offline right now and they provide about 50 percent of the material that we use in the United States. That is the molybdenum-99 issue.
[DM: What are the proposed solutions to the radioisotope shortage?]
R.A. There's a lot of activity, but I don't know if there is anything to date that would qualify as a substantial solution. Many of the things that we're dealing with in terms of potential solutions are more than a year away. The reactor in Canada is proposed to be offline a minimum of three months. The [Petten] reactor in the Netherlands, which is responsible for producing another 50 percent of the U.S. market is proposed to be offline for a month in July for preventive maintenance and also to be out an extended period next year. We're really scrambling to figure out a way to solve this problem in the short term...The Netherlands' reactor may reschedule the July outage based on the fact that we don't have the Canadian reactor operating.
[DM: What steps are being taken to produce these radioisotopes in the U.S.?]
R.A. We've already sent a letter to Chairman Markey [of the Select Committee on Energy Independence and Global Warming] to say that we are very much in favor of a domestic supply solution. The one that seems to be the closest to potentially coming online is to expand the activity at the research reactor at the University of Missouri in Columbia Missouri to also include molybdenum-99 production.
[DM: Does the reactor in Missouri have the capacity to meet U.S. demand for molybdenum-99?]
R.A. It has the capacity to produce about 50 percent of the U.S. market, which, when we're looking at both of our major sources being offline potentially next year, that's certainly better than nothing. The other thing happening is that the Australians built a new reactor with a major mission of isotope production and they aren't quite yet online, but I anticipate it being so in a matter of weeks. They will be able to supply a percentage of the U.S. market -- not a huge percentage, but I think somewhere between 10 and 20 percent. At this point, any additional capacity we can bring online will certainly help.
[DM: What other reactors are available for the medical supply of radioisotopes?]
RA: There are five major reactors [producing medical radioisotopes]. There's the one in Canada, one in the Netherlands, Belgium, France and South Africa. The Australian reactor is coming online as we talked about. It's a new reactor that was completed a year or so ago. There are smaller production capabilities in Southeast Asia, Morocco, and another in Argentina, but those are really only equipped to supply the local market and aren't in a position to have a major impact on worldwide demand. There's a collaboration between Covidien, which is a major supplier of molybdenum to the United States, and Babcock & Wilcox, the engineering firm, to use an old reactor design, but it is actually very well suited to use as a production vehicle for molybdenum-99. That is probably five to seven years away from fruition.
[DM: What new product or procedural trends are you seeing in the molecular imaging community?]
RA: The shift to using positron emission tomography (PET) technology. It's a different radioactive decay process and it enables us to do pretty precise quantitation. It gives us an opportunity to look at differences before and after therapeutic intervention. This is where the real excitement is in terms of molecular imaging in the field of nuclear medicine. We're able to put cancer patients, for example, who have non-Hodgkin's lymphoma on therapeutic protocol and tell within a week or so whether it's working or not. We can potentially avoid having those patients who aren't responding well from going through an entire course of therapy at an additional expense and potentially additional toxicity to the patient.
The sale of instruments is also down pretty dramatically. There's a lot of nervousness after the Deficit Reduction Act of 2005 [in effect since 2007]. They focused on reimbursement for imaging and actually proposed cuts in the reimbursement. People doing imaging for a living have been a little more gun-shy about going out and buying new equipment. And then there is the issue of where we're going to be in a year or two if health care reform goes through. Are we going to be able to adequately charge for the services we provide?
Congress has made some proposals in terms of instrument utilization. Right now our utilization rate for the instruments we use in imaging are factored at about 45 percent of the time. Obviously there are times when a patient is getting on and off the machine. The proposal has been that we increase that rate to 90 percent. Eventually the expectation is that every single minute that the clinic is open, somebody should be actively imaged on that machine. People are going to be reimbursed a little less for each imaging procedure because the presumption is that it's being used more efficiently. The perception is that 45 percent is too low and they're trying to bring it up to somewhere in between. The number I've heard in meetings with other radiology societies is that we expect to come out around 75 percent utilization rate. It's still pushing it, but it's better than 90 percent.
In parallel there has been some concern on the part of the companies that make the pharmaceuticals, in particular the positron emitting radiopharmaceuticals. The concern is that we haven't penetrated enough into the field. Probably the most exciting developments have been in the area of oncologic imaging. Some of the new radiopharmaceuticals that are proposed might have some exciting impact on our ability to be even more precise than with radioactive glucose in assessing what's going on with patients.
There are also some pretty exciting compounds that are being developed for imaging and being able to actually diagnose patients who have Alzheimer's or other forms of dementia.
[DM: What other challenges are facing the molecular imaging community?]
RA: Particularly with the PET agents -- we are injecting such a small amount of material that the likelihood of seeing any kind of a pharmacologic or toxic effect on the patient is almost nil, but in the current environment, with the problems that we've had with the MRI contrast agents and some of the ultrasound agents and toxicity associated with those, trying to get the FDA to relax their stand in terms of extremely rigorous toxicity studies for radiopharmaceuticals is almost impossible. That's been one of our challenges, because it's so expensive now to develop new radiopharmaceuticals that you almost have to have the imaging equivalent of a home run.
[DM: Are there any issues with funding for nuclear medicine research?]
RA: In 2006 the Office of Management and Budget (OMB) eliminated the nuclear medicine research funding in the Department of Energy budget. It was very unfortunate, because that funding was involved in supporting some of the very basic science that we do at the interface of the physical sciences and the biologic sciences. We've lost a lot of funding for basic radiochemistry activity and funding for improved instrumentation and improved software to do image analysis. We then started to try to work with Congress and we were finally successful in 2008 in getting that funding restored -- it was only about half of what we had in 2005, but nonetheless it got us going again. The challenge has been that the Department of Energy has been trying to move the focus of that funding toward other bioscience activities. Congress has been willing to work with us to put specific language in the appropriations bills that defines the mission of that funding to be for nuclear medicine research. That was true in 2008 and 2009. Since we're in the appropriations process for 2010, we'll continue to work with Congress to make sure that the funding continues to be defined for use in nuclear medicine research. That's been a constant struggle for us.
The competition for funding for nuclear medicine research at the advanced stage, when we would be approaching NIH to support that activity, has been challenging. Inflation adjusted, that funding has been going down fairly dramatically...probably about 25 percent. With the change in administration, they're talking about increasing support for research funded by NIH. We are hoping that will actually come to pass. It's certainly going to be evident when we see the appropriations for the fiscal year 2010.
--
Related news about the 56th SNM annual meeting, the radiopharmaceutical shortage, and nuclear medicine:
Industry Sector Report: Nuclear Medicine, DOTmed Business News, June 2009, now online
2009 SNM Annual Meeting Preview
https://www.dotmed.com/news/story/9118/
Medical Isotope Shortage Reaching Crisis Proportions
https://www.dotmed.com/news/story/9325/
Serious Concerns as Isotope Shortage Looms
https://www.dotmed.com/news/story/6859/
Canada Stops Medical Isotope Reactor Project
https://www.dotmed.com/news/story/6026/