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99MTechnetium-pyrophosphate (PYP) is a radionuclide isotope widely used for imaging and diagnostic purposes. It is the most common radioactive isotope tracer used for SPECT (single-photon emission computerized tomography) imaging of the brain, bones, lungs, kidneys, thyroid, heart, gall bladder, liver, spleen, bone marrow, salivary glands, lachrymal glands, and sentinel nodes.
Both major U.S. suppliers, Curium and Sun Radiopharma, have notified American and Canadian radiographers of a complete and total supply disruption. Here is Sun's notice:
Sun-Radiopharma-Supply-Update_12-01-2023.jpg
Sun Radiopharma seems to think that 99MTechnetium-pyrophosphate (PYP) will be available again early next year. This would be a much shorter duration than the two year shortage which developed back in 2009.
This shortage is not an FDA screw up, rather it is caused by the atomic energy authorities of several countries acting in concert. 99MTechnetium-pyrophosphate (PYP) is isolated from the decay of 99Molybdenum, which is in turn produced by exposing highly enriched 235Uranium (HEU) targets to the neutron flux in a nuclear reactor. After 9/11, atomic energy authorities decided to force new processes using low enriched 235Uranium (LEU) targets on the radionuclide producers to prevent nuclear proliferation.
The LEU based processes were forced on the industry before they were ready for prime time, and the HEU processes were ended prior to a reliable supply of LEU produced 99MTechnetium-pyrophosphate (PYP) was established. This created a severe supply disruption back in 2009, which was resolved by restoring the HEU process. It appears that the current shortage is due to a second effort to require LEU target production processes exclusively.
The U.S. Nuclear Regulatory Commission (NRC) is not getting any public notice for this fiasco, but they are indeed responsible for it.
So if I understand this right, healthcare once again pays the penalty for winner-take-all law enforcement policies.
This situation is an example of complete incompetence demonstrated by a government institution which focuses exclusively on public relations, to the detriment of end users. NRC is actually fairly competent within its sphere, but doesn't look beyond that sphere in its decisionmaking.
The 235Uranium (HEU) targets required for 99MTechnetium-pyrophosphate (PYP) production are easily managed by the extremely well armed DoE security apparatchiks. We are not talking a lot of 235Uranium here. Not enough to make even a small fission bomb even if terrorists captured every HEU target shipment in a year. But post 9/11, NRC wanted to show that it was at the forefront of antiterrorist efforts. So they demanded changes to a perfectly satisfactory process which resulted in a new process which simply did not reliably produce an acceptable product.
No one spoke for the medical community, much less the very sick patients who depend upon the radioimaging magic of 99MTechnetium-pyrophosphate before the NRC.
So patients get screwed. And NRC can hide behind "supply disruptions"
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