Race against clock to supply cancer-fighting radioisotope
Some 50,000 Americans each day depend on precarious supply chain easily disrupted by variety of menaces
In a cornfield here, past the shuttered General Motors plant and the Janesville Terrace trailer home park, a facility not seen in the United States in three decades could soon rise: a manufacturing plant that will make a vital radioactive isotope used to detect cancer and other potentially fatal maladies in millions of people every year.
Nuclear medicine imaging, a staple of U.S. health care since the 1970s, runs almost entirely on Molybdenum-99, a radioisotope produced by nuclear fission of enriched uranium that decays so rapidly it becomes worthless within days. But moly-99, as it’s called, is created in just six government-owned nuclear research reactors — none in North America — raising concerns about the reliability of the supply and even prompting U.S. scientists to warn of the possibility of severe shortages.
Some 50,000 Americans each day depend on a strange and precarious supply chain easily disrupted by a variety of menaces: shipments grounded by fog in Dubai, skittish commercial airline pilots who refuse to carry radioactive material and unplanned nuclear reactor shutdowns, including one in South Africa when a mischievous baboon sneaked into a reactor hall.
Delays that pose an inconvenience when they involve other commercial goods are existential threats in the daily global relay race of medical isotopes that disappear hour by hour. “It’s like running through the desert with an ice cream cone,” said Ira Goldman, senior director of global strategic supply at Lantheus Medical Imaging in North Billerica, Mass. But that race may soon be shortened. Propelled by persistent supply problems and fears that terrorists could seize U.S. uranium en route to foreign facilities, President Barack Obama signed legislation in 2013 prodding U.S. companies into the medical-isotope business.
The $100 million Janesville plant, in the hometown of Rep. Paul Ryan, the House speaker, is the first construction project to pass through the labyrinthine nuclear regulatory approval process since 1985. Shine Medical Technologies is building it with $25 million in federal funds.
Greg Piefer, the company’s founder and a nuclear engineer, has big plans for the cornfield: a plant that could manufacture as many as 50,000 doses of imaging agent a week.
The radioactive isotope injected into the veins of potential heart attack victims or bone cancer patients begins its journey in the heavily guarded U.S. nuclear stockpile.
The Department of Energy’s National Nuclear Security Administration ships Cold War-era uranium overseas, where the containers — sought by terrorists for dirty bombs — are secretively trucked to government-owned nuclear research reactors in the Netherlands, Belgium, the Czech Republic and Poland. (South Africa and Australia also use U.S. uranium to produce moly-99 in research reactors.)
Private companies rent time in the reactors to irradiate enriched uranium targets, producing an atomic alphabet soup. Nearby processing facilities fish out the moly-99, and the radioactive material is loaded onto commercial airline flights bound for the United States in protective containers.
Three companies dominate the U.S. market for moly-99 — Lantheus, Curium and GE Healthcare. They distribute the material to specialized pharmacies around the country where technicians process it into a diagnostic imaging agent called technetium-99. The companies work against a ticking clock: Because of its short half-life, just 66 hours for moly-99 and six hours for the imaging agent, the material must be quickly delivered to hospitals and administered to patients.
Countless things can go wrong, starting with the first step. The worldwide supply of moly-99 relies on a fleet of government-subsidized nuclear research reactors built mostly in the Khrushchev-Eisenhower era.
Even the Mayo Clinic in Rochester, Minn. can be left waiting for shipments of the so-called generators that contain the imaging agent. “We’ve had days when no generator comes in at all, or it’s been cut in half,” said Andrew Paulsen, supervisor of the clinic’s radiopharmaceutical lab.
U.S. patients consume nearly half of the world’s supply of moly-99. And despite plans to ramp up production in Australia, reactor construction is notoriously tricky.
If the United States is to grow a domestic moly-99 supply, it will probably rise from the corn and soybean fields in the United States’ Dairyland.
Rock County, Wis., has become the home to two of the three companies vying for control: North Star Medical Radioisotopes in Beloit, which has been awarded $50 million in federal grants, and Shine, or Subcritical Hybrid Intense Neutron Emitter, in Janesville.
Backed by $25 million in federal support, Piefer, Shine’s chief executive, has promised to build a nuclear accelerator and produce moly-99 by 2020.