Medical Device Daily Washington Editor

Repeated shut-downs of nuclear generators that produce radioisotopes for medical uses has grabbed Congress' attention as the American Medical Isotopes Production Act of 2009 (H.R. 3276) demonstrates (Medical Device Daily, July 30, 2009), but the bill needed until this past Wednesday to surface in committee. The bill is also the feel-good story of the day in that it enjoys bipartisan support, a rarity in the 111th Congress. The subcommittee had to cut the meeting relatively short for a vote on the floor, but the subcommittee's members seemed to feel that they'd heard everything they needed to hear from the witnesses.

Supplies of technetium-99 (Tc-99) for use in PET examinations have come under a substantial crunch due to the shutdowns, temporary or otherwise, of reactors outside the U.S. due to various problems with reactor vessel containment. Among these temporarily or permanently shuttered units is the high-flux reactor operated in Petten, the Netherlands, operated by the Nuclear Research Consultancy Group (also Petten) and the Chalk River reactor (MDD, May 27, 2009) operated by Atomic Energy of Canada (AEC; Mississauga, Canada).

One firm that supplies such isotopes to hospitals and other operators of PET imaging equipment, Lantheus Medical Imaging (Billerica, Massachusetts), recently signed an agreement with NTP Radioisotopes (Pretoria, South Africa) to obtain supplies of the Tc-99 precursor material, molybdenum-99 (MDD, May 22, 2009), but the supply crunch continues and many on Capitol Hill are apparently interested in ensuring that American providers have a reliable domestic source.

Rep. Edward Markey (D-Massachusetts), chairman of the subcommittee on energy and the environment in the House Energy and Commerce Committee, said to open the hearing, "the U.S. is facing a crisis in nuclear medicine" and noted that Tc-99 is "needed for nearly 50,000 medical procedures every day."

"Worst of all, currently the U.S. does not produce any of this isotope," relying on reactors in other nations, "some of which are literally falling apart," Markey said. He noted that Canada's Chalk River reactor might never come back on line and mentioned the temporary shutdown of the Petten reactor as well. He added that a recent survey indicated that 80% of practitioners had delayed procedures because of the shortfall and that almost half had cancelled procedures altogether. "It is absolutely vital that we act to bring a robust domestic supply," Markey asserted.

However, Markey indicated that Congress hopes to hit a two-for-one with H.R. 3276, which has provisions that will tamp down the use of high-enriched uranium (HEU) in favor of low-enriched uranium (LEU). The bill, he said, will help to slow down or even "end the export of high-enriched uranium."

Seconding Markey's views was the ranking GOP member of the subcommittee, Fred Upton (Michigan), who said, "we are really in a crisis. Sixteen million procedures a year depend on" the radioisotope. Upton added that the bill would help ensure "that a robust and reliable supply of the most critical medical isotopes are produced in the United States."

The first witness to speak was Parrish Staples, PhD, of the National Nuclear Security Administration at the Department of Energy, who noted the Department agrees with the objective of "eliminating the use of highly-enriched uranium in civilian nuclear applications.

Staples seconded a recent report by the National Academies, which is said to have taken the position that HEU "is no longer required" to produce molybdenum-99. He added, "we agree with the language in the proposed legislation to accelerate the conversion of HEU reactors worldwide to LEU."

Staples indicated, however, that DoE has not exactly been sitting on its hands in this respect. "We have converted 57 HEU reactors globally to LEU," he said, resulting in a reduction of 320 kilograms of HEU from reactor stockpiles. Regarding the bill's provision that would ban exports of molybdenum-99 derived from HEU sources in seven years, he said "we expect the seven-year time frame ... is more than adequate to ensure that a sufficient supply of non-HEU" molybdenum-99 will be available to supply U.S. needs.

Steve Larson, PhD, chief of nuclear medicine at the Memorial Sloan-Kettering Cancer Research Center (New York), told the committee that the clinic has seen a reduction of as much as 25% in the availability of Tc-99 in recent months and that suppliers "are warning about the possibility of even deeper reductions ... on the near horizon."

Larson said he sees the bill as "good public policy," adding, "I now believe that if medical isotope producers want to convert to LEU, they can do so without undue" cost, a claim buttressed by the report by the National Academies, which is said to have concluded that most reactors can make the switch without increasing the cost of the radioisotope by more than 10%.

Michael Duffy of Lantheus Medical Imaging (Billerica, Massachusetts), said the firm "strongly endorses" the bill and noted "approximately a third of the 'moly' made outside the U.S. decays before" reaching Lantheus, which some at the firm refer to as "buying ice on a warm day."

Duffy said that the Council on Radionuclides and Radiopharmaceuticals (CORAR; Moraga, California) backed the development of "alternative technologies" to ensure the supply of Moly-99 and Tc-99. When Markey asked about the viability of the seven-year deadline regarding the export ban, Duffy said CORAR is concerned that due to forces beyond its control, "seven years might not be sufficient" to bring LEU production online in sufficient quantities to comply with the ban. Larson said, "my feeling is that seven years is probably enough," in response to Markey's question, a view seconded by Staples.

Mark McCarty, 703-268-5690;