Restrictions on Use of Cancer Diagnostic Tools Expected as Worldwide Shortage of Isotope Tc-99m Worsens

As the worldwide community has been experiencing a shortage in the supply of isotope Technetium 99m (Tc-99m) since Canada's National Research Universal (NRU) reactor shut down in May 2009, a new reactor in the Netherlands is scheduled to start a six-month shutdown for scheduled repairs tomorrow. The Canadian and Netherlands' reactors together produced approximately 75% of the world's supply. The remaining operating reactors are the BR2 reactor in Belgium, the Osiris reactor in France, the Safari reactor in South Africa and the OPAL reactor in Australia, all in operation for 40 years, except the Australian plant which started to be operational three years ago.

The medical isotope Tc-99m is typically present in over 80% of radiopharmaceuticals, used by healthcare providers in nuclear medicine to image parts of the body and help diagnose disease. Radiopharmaceuticals are key to performing imaging studies of the heart, blood, brain, thyroid, lungs, liver, kidneys and skeleton and are used to diagnose heart-related diseases and cancer—such as bone and breast tumours. According to Nature, around 70,000 nuclear medicine tests are performed every day worldwide.

Restriction in Use of Cancer Diagnostic Tools

In the coming years, the use of cancer imaging tests is likely to be rationed, as is already the case in Canada. In a press release, the U.S. FDA recommended that healthcare providers try to maximise the use of Tc-99m by prioritising and supporting the most clinically important diagnostic tests and by using alternative diagnostic procedures when possible. At the end of January, Covidien predicted the medical isotope will be unavailable between 21 and 25 March 2010 worldwide following the shutdown of the Dutch reactor. On a more positive side, the long-term outlook might be improved by the recent agreement inked between Poland's Institute of Atomic Energy and Covidien—a major supplier of Tc-99m with Lantheus in the United States and Canada. The latest FDA press release on the subject is available here.

New Source of Isotopes in Poland

Covidien, the leading supplier of Molybdenum 99 (Mo 99), and the Polish Institute of Atomic Energy yesterday partnered to increase the supply of medical isotopes worldwide. The Maria Research Reactor located in Poland is likely to help Covidien supply more than 1 million additional patients in the first six months after the reactor starts producing Mo 99. Covidien expects to market the medical isotope Tc-99m, derived from Mo 99, in Europe within 30 days. However, the situation is not cleared so far in the United States and Canada where approval from the FDA and Health Canada are pending.

Outlook and Implications

The current shortage could be partly resolved if the 52-year-old Canadian reactor, which provides 50% of the U.S. supply, reopens as scheduled in the Spring. But this is rather uncertain knowing the ageing structure of the reactor and the many safety issues involved. In the meantime, the encouraging agreement signed in Poland will help Covidien partly meet an important demand for the isotope, mainly in Europe. It remains uncertain when Covidien will be able to commercialise the Polish production in Canada and the United States, where the FDA and Health Canada's authorisation are still pending. However, what is certain is the fact that the week of shortage expected in March will not be solved by this new deal as the production is scheduled to begin at the end of March or beginning of April.

The unprecedented crisis has forced the international community to seek long-term solutions in order to ensure a continuous provision of life-saving tests, especially in oncology. If the isotope crisis were to worsen, guidelines would have to be issued by healthcare authorities in order to prioritise the use of medical isotopes at a time when early diagnostics are becoming increasingly valued in the fight against cancer and heart-related diseases. A restriction in the use of diagnostic tools would prevent healthcare professionals from providing the best available care to patients. Cancer imaging tests not only enable medics to diagnose, but also to offer more personalised treatments to patients. The fact that healthcare providers will have to support the most clinically important diagnostic tests is the sign that a worldwide short- and long-term solution is needed to tackle this isotope crisis, caused by so few reactors being able to produce Technetium 99m.