DOE seeks private partnerfor medical radioisotopes production

Los Alamos, Sandia funding remains uncertain

The U.S. Department of Energy clarified its plans for providing medical isotopes to the U.S. nuclear medicine community at June’s Society of Nuclear Medicine meeting in Los Angeles. At the meeting, the DOE emphasized its plans to seek privatization of the commercial production of medical isotopes, rather than attempting to distribute such isotopes as molybdenum to the U.S. market itself.

This plan is consistent with the DOE’s ongoing strategy, according to Owen Lowe, director of isotope production and distribution: The DOE has always stressed medical isotope research rather than commercial distribution, and has long sought to find private partners for isotope production, Lowe said. Yet industry watchers might disagree, since the DOE has been developing molybdenum production facilities for the commercial distribution of the isotope since the mid-1990s.

In 1996, the DOE announced that it had chosen two nuclear reactors in New Mexico for the production of molybdenum-99, the raw material for the commonly used radioisotope technetium-99m (SCAN 9/25/96). The Sandia National Laboratories and Los Alamos sites would provide an alternative to molybdenum produced by reactors at the Atomic Energy of Canada’s (AECL) Chalk River site, for many years the world’s major provider of the isotope. AECL and its private partner, MDS Nordion, have produced 80% of the world’s molybdenum, and have been subject to periodic labor disputes that jeopardize production.

A year after the DOE selected its reactor sites, the project was still mired in funding snafus, despite the latest in a series of AECL walkouts (SCAN 7/9/97). In 1998, the DOE seemed to rally when it announced that its Sandia reactor would be online by the end of the year. But at this year’s SNM show, the Department reported that although the installation of molybdenum production equipment could be complete at Sandia by the end of 1999, the project’s funding continues to remain uncertain. Even if the facility is completed, the equipment will not be commissioned, and moly samples would not be taken through the FDA approval process. Instead, the DOE intends to focus its efforts on finding a private company to take over the project and produce the isotope commercially.

The DOE maintains that it has always intended to be a backup supplier of medical radioisotopes, according to Lowe.

“Our plan at Sandia is to bring the project to a point where we might get some interest from a private company,” Lowe said. “(The DOE) got into molybdenum/technetium production because users were uncomfortable with the single source (MDS Nordion). But our philosophy has always been to be a backup supplier.”

But with the Sandia facility almost ready for moly production, the DOE finds itself in a catch-22 situation. Even if the Sandia facility’s moly preparations are completed this year, the site won’t be at a point where molybdenum production would be a viable project for a private firm, according to Lowe. Because of funding constraints, the DOE may be unable to invest further in the project to bring it to that point.

“In the last several months we’ve gone out with a notice asking for interest in taking over the (Sandia) project and bringing it to completion,” Lowe said. “But where we will be at the end of 1999 is not far enough along for a private company to be interested in finishing the project. Their investment would be too great. But depending on how the FY2000 budget goes, we may not be able to make further investment of taxpayer money.”

Production of molybdenum has become less centralized in the last year, Lowe said. MDS Nordion now supplies approximately 60% of the U.S. supply of the isotope, rather than 80%, as was the case in 1998. Ten percent of the world’s molybdenum is produced by reactors in Belgium and South Africa, and radiopharmaceutical firm Mallinckrodt of St. Louis produces about 30% of the U.S. demand at its reactor in Petten, the Netherlands, although it uses that moly to supply its own needs.

Still, although MDS Nordion’s hold on the market has decreased slightly, Lowe admits that if MDS Nordion’s supply was disrupted, it would be difficult to furnish U.S. physicians and researchers with the molybdenum they need, and the nuclear medicine community remains in the same tenuous place it has occupied for the past four years.

“If we lost the Nordion supply, we couldn’t meet demand in the U.S. for very long,” Lowe said.