Made in America?

By Chris Gaerig

Robert Atcher, PhD, MBA

You would hardly think that snowstorms, the recent volcanic eruptions that halted air traffic to and from Europe, and even 9/11 would have a significant impact on medical imaging, but due to a lack of domestic production of the medical isotope molybdenum-99, all of these events have caused difficulties for the imaging community. Because of this limitation, legislation has been introduced in the House of Representatives and Senate, which would approve the creation of US-based facilities to produce the nuclear isotope used in medical imaging.

Senator Ed Markey (D-Mass) is responsible for the origin of the American Medical Isotopes Production Act of 2011, currently numbered Senate Bill 99 (S 99). His primary concern was with the proliferation of high-enriched uranium for the production of molybdenum-99, a nuclear isotope used to create technetium-99m, which is utilized in about 80% of the imaging in nuclear medicine. After discussions with the Society of Nuclear Medicine (SNM), the bill was expanded to include the development of domestic alternative production of molybdenum-99, as well as the creation of a path for the disposal of nuclear waste created through the production of the isotope.

“Those are the three major issues,” said Robert Atcher, PhD, MBA, chairman of SNM’s Commission on Government Affairs, chair of the medical isotopes task force, and past president of SNM. “One is the proliferation issue, which will put a deadline in the legislation for the shift from high-enriched uranium to low-enriched uranium; to identify funding to support research on alternative technologies; and then to identify a disposal path for the materials produced when there is domestic production of that medical isotope.”

The US medical imaging community has been relying on a number of foreign isotope production facilities—including old facilities in Canada and the Netherlands, which account for 65% to 70% of the molybdenum production worldwide—that, for various reasons, are becoming less viable sources. As such, the industry will need a reliable, domestic source of molybdenum-99. In recent years, the National Nuclear Security Administration (NNSA) has been funding four US-based projects that are developing alternative processes for the creation of the isotope, which will hopefully gain government support and begin producing the isotope on a domestic level.

“We trusted the Canadians to provide for the US market through the mechanisms that were already in place,” said Atcher. “When those all seemed to go awry, we were caught flat-footed. The projects that NNSA is funding have the requirement that they can demonstrate the production of a substantial percentage of the US market by 2013.”

When the bill was first introduced to the last Congress, it passed through the House of Representatives with a resounding majority, but was held up in the Senate by a single Senator who has since retired. Minor changes were made to S 99, which has been reintroduced in the hope that it will pass through both the House and Senate before making its way to the White House for the President’s signature.

This does not come without its share of complications. With the House moving from a Democratic to Republican majority, the SNM is concerned that the bill will meet opposition because of the cost. But after an analysis by the Congressional Budget Office, the legislation was found to be revenue-neutral, which supporters hope will offset any opposition.

It’s now a waiting game for supporters of the bill, but Atcher seems confident that the bill will pass. “We didn’t get any strong indications on when the Senate was going to act on the bill,” said Atcher. “Everything seems to be in flux right now, and there’s always the crisis of the moment. From my standpoint, the good news was that we had gotten it through all of the legislative processes except for the fact that one Senator was able to hold up the legislation.”