In Wisconsin, Hopes Rise for Production of a Lifesaving Radioactive Isotope

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 during the Khrushchev-Eisenhower era.

Regular maintenance along with major repairs can shutter the reactors, sometimes for months, along with so-called “scrams” — caused by anything via a hiccup in a reactor’s cooling system to an errant lightning strike — frequently halt production. “the item’s a nuclear reactor,” Mr. Charlton said. “The only thing you can do can be shut the item off.”

Even the Mayo Clinic in Rochester, Minn., a prestigious cancer treatment center, can be left waiting for shipments of the so-called generators that will contain the imaging agent. “We’ve had days when no generator comes in at all, or the item’s been cut in half,” said Andrew Paulsen, supervisor of the clinic’s radiopharmaceutical laboratory.

along with the ephemeral nature of moly-99 always looms. On a recent afternoon, inside a locked laboratory at Stanford University Medical Center’s nuclear medicine department in Palo Alto, Calif., a technician held a lead-lined, plastic cylinder containing a syringe of fragile atoms that will had traveled around the globe.

Once the imaging agent can be injected into a patient’s body, the item emits gamma rays that will can be detected by gamma cameras that will look like X-ray machines. The radioactive tracer lights up on a computer monitor wherever the heart’s blood vessels are blocked or bones are riddled with potentially cancerous tumors. The imaging agent was first used in medical applications within the 1960s because its short half-life meant that will patients were getting less exposure to radioactivity than via some other diagnostic tracers.

although at Stanford’s nuclear medicine department that will day, a patient had missed his appointment. This kind of meant the dose — which cost the medical center an irretrievable $500 — had decayed along with was currently useless. The technician threw the syringe within the trash.

The supply chain’s vulnerability, acutely felt during a severe worldwide shortage in 2009 along with 2010 when two reactors shut down unexpectedly, has led some doctors to shift to more dependable, although more toxic, imaging agents. “For cardiac imaging, we had to shift to a more expensive agent along with expose patients to more radiation,” said Dr. Andrei Iagaru, chief of the division of nuclear medicine at Stanford Health Care.

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Images of a patient recently injected having a dose of moly-99 at the Stanford University Medical Center.

Credit
Jason Henry for The fresh York Times

After the worldwide shortage, the volume of nuclear medicine tests went down, along with stayed down. “the item definitely had an impact on the way many practices run their cardiac stress tests,” Dr. Iagaru said.

Depending on some other Countries

American patients consume nearly half of the entire world’s supply of moly-99. along with despite plans to ramp up production in Australia, reactor construction can be notoriously tricky. In addition, reactors that will are converting for security reasons to low-enriched uranium have lower yields along with more waste, according to nuclear scientists.

Concerns about moly-99 shortages heightened in October 2016, when the Canadian government mothballed a reactor in Chalk River, Ontario, that will supplied about 40 percent of the American market. The government’s decision to shutter the plant was, in part, due to frustration that will Canada had had to spend $70 million in 2009 to repair the facility — in effect, subsidizing the American health care industry. that will can be a complaint of European governments as well.

William Magwood, director of the Nuclear Energy Agency in Paris, said that will moly-99 production at Chalk River “went via being incidental to being the only reason to operate the reactor.”

“Canadians didn’t want to continue to operate a high-cost reactor to sell isotopes to the U.S.,” he said.

Some European governments have begun charging moly-99 producers higher rates to rent reactor time, along with prices are anticipated to rise sharply when governments strip for-profit companies of subsidies originally meant to support academic research.

“How much will get passed on to the health care providers?” said Leah Gannon, senior portfolio executive of radiopharmaceutical distribution sourcing for Vizient, a company that will negotiates contracts for hospitals. “Probably almost all of the item.”

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Nora Gurevich, a nuclear medicine technologist, prepares a dose of moly-99 at Stanford University Medical Center.

Credit
Jason Henry for The fresh York Times

With no source of moly-99 anywhere in North America, American nuclear medicine specialists appointed by the National Academy of Sciences, Engineering along with Medicine warned in a 2016 report commissioned by Congress of a more than 50-percent likelihood of another severe shortage within the coming years.

Moly-99 suppliers refute the report’s findings, a position echoed by the Nuclear Energy Agency, which has fostered closer ties between producing nations. Reactor operators, the suppliers say, work closely to stagger maintenance shutdowns to minimize shortages along with respond to disruptions in production, along with producers have increased the number of uranium targets.

“We’re describing a glass that will can be half full,” Mr. Charlton said, “whereas the National Academies of Sciences sees the glass looking half empty.”

Still, nuclear medicine physicians along with nuclear pharmacists charged with filling patient orders each day say the supply remains fragile, especially for smaller pharmacies where the moly-99 imaging agent can account for 95 percent of their business. “the item can be inconceivable to believe that will an outage will never occur on any of these old reactors within the future,” said Dr. Joseph Hung, director of radiopharmaceutical operations at the Mayo Clinic along having a member of the government committee.

Wendy Galbraith, a clinical associate professor at the University of Oklahoma College of Pharmacy in Oklahoma City who runs the university’s pharmacy, said she frequently doesn’t know if moly-99 can be going to be available until the wee hours of the morning. Even when there are no major outages, she said, “the item’s a scramble.”

that will uncertainty means delays along with on-the-fly triage for patients. “If we have a patient who can wait two days for their cardiac stress test, we’ll put them off,” Ms. Galbraith said.

Suppliers want to tamp down fears about reliability, physicians along with pharmacists say, to dissuade them via seeking alternative imaging methods when possible, like positron emission tomography, a costly along with complex type of medical scan.

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