Sen. Christopher "Kit" Bond, R-Mo., co-chair of the Senate National Guard Caucus. Image source: National Guard

SNM, the American Society of Nuclear Cardiology, the American College of Cardiology and a coalition of medical and national security organizations have urged Sen. Christopher S. "Kit" Bond, R-Mo., to lift a “hold” on the American Medical Isotope Production Act (H.R. 3276), and permit a vote by the U.S. Senate, which passed the U.S. House of Representatives by a vote of 400-17. Several radiologists and nuclear medicine specialists spoke to their concerns if the U.S. continues to rely on foreign sources for medical isotopes.

The bill will allow the production of molybdenum-99 (Mo-99) in the U.S., and to condition and phase out the export of highly enriched uranium for the production of medical isotopes. The nuclear medicine community worries that unless Sen. Bond lifts his "hold," the measure will die when Congress recesses later this year.

Domestic Mo-99 production
The legislation in two ways would foster domestic production of Mo-99 for medical isotopes without highly enriched uranium. First, it would subsidize construction of production facilities by authorizing government cost-sharing. Second, it would facilitate operation of new facilities by authorizing the government “to retain responsibility for the final disposition of radioactive waste” under uranium-lease agreements – without which operators would have nowhere to dispose of this waste.

“It would be wise for U.S. to have a domestic supply of technetium-99m considering that we use as much of it as the rest of the countries of the world combined,” Andrew J. Einstein, MD, PhD, director of cardiac CT research, and assistant professor of clinical medicine, Columbia University Medical Center in New York City, said in an interview.

There is a global shortage of this agent which has been exaggerated by problems with production in Canada and to a lesser degree in the Netherlands. There are no major or minor suppliers currently within U.S. "As a result, we are dependent upon the fluctuations of the worldwide supply chain of which we have no control. For example, this week in our laboratory, it’s been more challenging to get doses of technetium-99m due to this shortage. This is a problem that is affecting hospitals, physician practices and patients throughout the U.S. on a regular basis,” Einstein added.

The bill offers the potential in several years establishing not just one but multiple sources for medical technetium in the U.S. “It would enable us to stop exporting the weapons grade uranium to other countries for the production of technetium and it would move an industry that is outside the U.S. to inside the U.S., thereby creating jobs here. There are various reasons why it would be beneficial to people in the U.S. to have domestic production of technetium,” he noted.

In an email response, a member of Bond's staff claimed that the bill could interrupt foreign production of isotopes prior to creating adequate domestic supplies. But experts from the U.S. Department of Energy (DoE), National Academy of Sciences, and private industry testified repeatedly that the bill would enable sufficient domestic production within about five years, while not cutting off exports until seven years with an addition of six years (13 years) after the date of enactment of the isotope act.

Another concern, according to Bond's staffer, is that “no facilities that could make cancer medicine under the bill’s ban yet exist.”

However, the University of Missouri’s research reactor provides the best opportunity because it is an operating reactor which is in good shape and within the borders, 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., said in an interview.

Now the problem with the Missouri research reactor is that the requirements for getting the funding from the DoE requires a 50-50 cost match and for a state-based university in the current economic environment to try to come up with such an amount of money without having a private partner is just too much, said Atcher. There are eight other ongoing projects identified which may further boost domestic production capacity under the legislation in addition to the University of Missouri research reactor.

There are other concerns when the U.S. depends on the global supply of Mo-99. “When the volcano erupted, we suddenly couldn't get any materials from Europe because the planes were not flying. In addition, there are homeland securities issues. If we were to have a a homeland security incident, we will close the borders and all movement of radioactivity would stop, which include medical isotopes. Security originally stopped the movement of medical isotopes after 9/11 and the people in the field had to get dispensation to allow the material to move across the border,” said Atcher.

Serious consequences
There are serious consequences if this legislation is not passed, Alan J. Kuperman, PhD, associate professor and coordinator, Nuclear Proliferation Prevention Program, LBJ School of Public Affairs, University of Texas at Austin, said in an interview. “By blocking this legislation, it is going to make it harder for these projects to receive matching federal fund. That means there will be less production of medical isotopes, a continuous shortage causing patients to potentially receive suboptimal imaging by resorting to inferior technology, or patients will have to undergo invasive procedures or they just would not get the diagnostic tests for cancer or heart disease. That is the real-world consequence to Bond’s opposition,” he said.

Worst case scenario, according to Atcher, is that when the new Congress comes in January, Bond would have retired, meaning the bill has to be reintroduced and it would have to go through the House again. But Atcher is concerned that if they wait that long, there will be other issues associated with the budget or other factors that might slow down the process.

“It is not controversial legislation. It is supported by doctors, radiologists, producers of isotopes, the nuclear nonproliferation community, DoE, National Academy of Sciences and every single interest group. There is no interest group that is opposing this and only Bond is opposing this and he is going to increase the risk of shortage of medical isotopes,” said Kuperman. He urged Americans to write a letter to Bond to support this legislation and ask him to allow the Senate to vote on this.

“Physicians practicing in Missouri should reach out to their senator and express their concern for these actions which is really deleterious for the health of the people in Missouri,” added Einstein.