Fast Facts on the Worldwide Medical Isotope Crisis

[darrels joy]

This is why I'm still angry about the destruction of the Fast Flux Test Facility located at the Hanford Nuclear Reservation!

Fast Facts on the Worldwide Medical Isotope Crisis

What is a medical isotope?
A medical isotope (or radioisotope or radionuclide) is a very small quantity of a radioactive substance that is injected into millions of patients each year to detect, diagnose, treat or evaluate serious illnesses such as cancer, heart or brain diseases. Approximately 70 percent to 80 percent of all nuclear medicine procedures use Technetium-99m (Tc-99m) derived from Molybdenum-99 (Moly-99 or Mo-99), which is produced in nuclear reactors.

What is Moly-99 and Tc-99m?
Molybdenum-99 (Moly-99 or Mo-99) is a medical isotope (also called a radioisotope) created in a nuclear fission reaction when a neutron is added to the stable isotope Moly-98. Approximately every two-and-a-half days, half of the Moly-99 created decays into Technetium-99m (Tc-99m). The Moly-99 and Tc-99m combination is delivered to hospitals and other nuclear medicine facilities in small lead generators. A radiopharmacist then formulates the agents for a variety of medical tests. The United States uses over one-half of the world's Moly-99, roughly 40,000 doses of Tc-99m a day during a five-day week.

How does it work?
Tc99m is labeled to a variety of compounds that target specific organ systems such as the heart, or go to specific disease sites in the body after injection, and can be imaged with specialized equipment, such as a positron emission tomography (PET) or single photon emission computed tomography (SPECT) scan. These imaging devices not only pinpoint the exact location of the disease, but also track its biologic activity. Physicians use the results of these tests to diagnose disease, identify the best treatment and also measure and monitor response to treatment. Within six hours after injection, the Tc-99m disintegrates into a harmless, relatively non-radioactive state of Tc-99.

Where is Moly-99 made?
Ten years ago, 90 percent of medical isotopes used in the U.S. were produced domestically. Today, less than 10 percent are made domestically. The vast majority of Moly-99 is made in five countries:

COUNTRY	CITY/PROVINCE	FACILITY NAME	REACTOR AGE	% WORLD SUPPLY	MEGAWATTS
Canada	Rolphton, Ontario	NRU Chalk River	52 years old	31%	135
The Netherlands	Zijpe	HFR-Petten	47 years old	33%	45
Belgium	Mol	BR2	47 years old	10%	100
France	Saclay	OSIRIS	42 years old	8%	70
South Africa	Pelindaba	SAFARI	43 years old	3%	20
Australia	Sydney	OPAL	2 years old	NA	20

What happened at Chalk River?
The NRU (National Research Universal) reactor in Ontario, Canada, was shut down on May 14, 2009, after a power outage. During inspections the next day, a heavy-water leak was discovered (the third in two years).

Sources expect the facility to remain offline for at least three months. The Chalk River facility had to be shut down for a month once before in late 2007 after officials discovered emergency backup power wasn't connected to two pumps that prevent a meltdown. Roughly 30 percent to 40 percent of the world's Mo-99 comes from Chalk River, and there are eight million procedures performed each year in the U.S. using Chalk River Mo-99.

Further complicating the situation are plans to shut down the Petten reactor in The Netherlands for a month this summer. Together, the Chalk River and Petten plants supply 64% of the world's Moly-99.

What is the impact on patient health?
Each year more than 20 million people in the US, 2 million in Canada, 10 million in Europe, and 14 million in the rest of the world benefit from nuclear medicine tests involving medical isotopes. Our greatest concern is that patients around the world will not receive the vital testing they need to detect and treat life-threatening diseases at the earliest possible stage. Just as early detection increases the likelihood of better outcome or survival, delayed testing and treatment puts the patient at unnecessary risk, and often increases the complexity, risk and cost of treatment when it is eventually started.

Are there alternative agents that can be used for tests whenever Moly-99 is unavailable?
Yes. For example, bone scan images can be performed with a lower dose (15 or 20 mCi instead of 25 mCi) of F-18 Fluoride, provided that insurance companies and Medicare approve payment as a stopgap measure during the temporary shortage. For heart (myocardial perfusion) scans, doctors can use Tl-201 for the rest study (up to 75% reduction) and schedule follow-up rest and stress studies with up to 50 percent less Tc-99m.

Nonetheless, interruptions in the Moly-99 supply lead to the use of secondary medical diagnostic tests that are not as good as Moly-99 and Tc-99m. These alternatives are more expensive, more invasive, less accurate and can sometimes inadvertently result in larger radiation doses to patients.

What are the security risks of shipping radioactive materials across international borders?
Currently, the majority of Moly-99 is made using highly-enriched uranium-235 (U-235). Some politicians and activist groups have expressed concerns that if these materials fall into the wrong hands, they could be used for potentially destructive purposes. However, these radioactive materials are extremely well-guarded. Once Moly-99 and Tc-99m arrives at a hospital or radiopharmacy, a very limited number of people have access to these materials, which are locked in secure locations. While it is possible to produce Moly-99 with low-enriched uranium (LEU), there is no large-scale, commercial operation that has developed and demonstrated the ability to create medical isotopes with LEU on a scale sufficient to meet patient demand. That is why policymakers must provide sufficient funding and allow adequate time to facilitate the transition from HEU to LEU with minimal disruptions to patient care.

What are the environmental risks surrounding the aging reactors?
Officials at Chalk River and other facilities have assured policymakers and the public that there are no significant public health risks associated with the recent leaks and shut downs. However, since the average age of the top five Moly-99 reactors is 45 years old, prudence dictates the serious exploration of building newer, safer and more efficient reactors to preempt any tragic environmental incident.

Is there an economic impact caused by the isotope shortage?
Approximately 90 percent of Technetium-based radiopharmaceuticals like Tc-99m are distributed by commercial radiopharmacies or nuclear pharmacies. There are about 500 commercial nuclear pharmacies operating in the U.S. to prepare and distribute 40,000 doses of patient-ready radiopharmaceuticals per day to hospitals and clinics throughout the country. A billion dollar industry, these 500 pharmacies employ over 1,500 pharmacists and 10,000 support staff from their communities. Without a stable and secure supply of 99Mo, these pharmacies and the communities in which their employees reside face great economic hardship. The entire nuclear medicine and nuclear pharmacy industry is in jeopardy.

What is SNM doing about the Moly-99 crisis?
[IMG]file:///C:/DOCUME~1/Darrel/LOCALS~1/Temp/061509map.jpg[/IMG] SNM's leadership has engaged in high-level discussions with nuclear medicine experts from around the world. SNM created a task force in 2008 to explore alternatives to the world's aging isotope production facilities. The task force has identified two alternatives as being the most viable to provide a domestic supply of medical isotopes: the University of Missouri Research Reactor Center (MURR) in Columbia, Missouri, and in the longer-term, the Babcock & Wilcox (B&W)-Covidien collaboration. MURR could meet approximately 50 percent of the current market need for Mo-99 with little change to the current reactor. SNM also recommends that the Department of Energy's (DOE) National Nuclear Security Administration (NNSA) fund the construction and development of the processing capability, especially since the major thrust of the NNSA is to demonstrate a high-level production path using low enriched uranium (LEU). Success at MURR and by Babcock & Wilcox would immediately reduce the amount of highly enriched uranium (HEU) that is now exported by the U.S. for Mo-99 production by 50 percent.


http://interactive.snm.org/index.cfm?PageID=8803&RPID=7739