SNM past president calls for more aggressive solutions to moly shortage

Some progress is being made to avert to the widespread molybdenum-99 (Mo-99) shortage in the U.S., but it’s not enough in the short term and especially not in the long term, according to Robert Atcher, PhD, MBA, immediate past president of SNM and University of New Mexico/LANL professor of pharmacy, bioscience division at Los Alamos National Laboratory, White Rock, N.M. Atcher spoke to members of the press Monday at the 57th annual meeting of SNM.

“One year ago, SNM held a news conference in Toronto and called on the world’s political, regulatory, industry and medical leaders to work aggressively to find a viable solution to the worldwide medical isotope shortage crisis. Time was critical,” Atcher said. “Sadly, things are not much better now than they were in June 2009. And there is plenty of blame to go around. We cannot remain silent anymore.”

Through calculated, direct and often harsh statements, he called for more long-term solutions in both utilizing the parent isotope of technetium-99m (Tc-99m)—the most widely utilized radioisotope in the world for molecular and nuclear diagnostic imaging studies—from new sources in Europe and generating supply someday in the U.S. Along the way, Atcher did acknowledge that some progress is underway.

“There is a ray of hope from Canada,” he said. According to the Atomic Energy of Canada, repairs to the NRU reactor at Chalk River are 97 percent complete. The reactor still must undergo a restart protocol and the repairs proven stable before production can resume.

Promising news is coming from Europe as well, Atcher noted. The Petten reactor’s repairs in the Netherlands are proceeding on schedule without any problems and are projected to be completed on time in August. The Maria reactor in Poland has generated material that has been approved for use in the U.S. Material from this reactor will be distributed in the U.S. by Covidien. A reactor in the Czech Republic has been identified as capable of providing Mo-99 and steps are being taken to qualify that material for the U.S. market, which is expected to take three months. Once available, the material will be distributed by Lantheus. In addition, reactors in Germany and Russia also have been identified as potential contributors to the Mo supply.

He noted that these new alternatives bring the disadvantage of distance, being farther from the U.S., more challenges for transportation and the vulnerability of problems such as the weather and volcanic eruptions experienced this spring.

But to Atcher, it’s too little, too late. “Several years ago, those of us in the nuclear medicine community in the United States were reassured by government and industrial parties in Canada that there was no need to develop a production capability for Mo-99 in the U.S. because Canada’s new Maple reactors would solve the problem. We took that promise at face value, stopped development in the U.S. and waited. Unfortunately, our friends to the north failed to deliver on their promise and canceled the project two years ago—which has put the whole molecular imaging community in the U.S. in a terrible bind. So, let’s call it like it is and say that Canada assured us that there would be a long term solution, and Canada needs to deliver on that assurance. That means that its political leaders must show the courage and resolve to make the ethical decisions and make good on their promise."

Canada announced several programs, according to Atcher, to alleviate the shortage by engaging in either research projects of questionable technical merit, responded to a report by an expert panel recommending that the NRU be replaced by a similar multi-purpose reactor by saying that their intent is to only provide medical isotopes for the Canadian market, and most recently announced funding for a project that will do nothing to supply material in the short term.

In the U.S., the Markey bill (HR 3276)—which identified funds for a U.S.-based production of Mo-99 and control of radioactive waste—has passed the House of Representatives and is awaiting passage in the U.S. Senate. It is being held up by one senator because of concerns about the commitment to a solid timetable for production of Mo-99. The bill proposes that isotopes can be made effectively with low-enriched uranium (LEU).  A final call for proposals is set for June 11, with 2013 as the deadline for substantial production.

“We call on Canada’s companies, lawmakers and regulators to get their respective act together. You made a commitment, now honor it,” Atcher said. “We call on the U.S. Senate to follow the House’s lead and authorize sufficient funds to build a new production system in the U.S. Delays won’t generate any benefit.

“We can’t wish away the shortage of medical isotopes,” he said. “The lack of decisive action by the stakeholders in Canada and the United States is a modern day equivalent of fiddling while Rome is burning. The clock is running out. Patients can’t afford inaction much longer. It’s time to end the medical isotope shortage.”