It is time to add a new phrase to the dictionary of disasters: Technetium-99 -- also known as Tech-99 or Tc99m. If you, or someone you know, suffers from heart disease, cancer or a score of other medical conditions, a shortage of Tc99m could be life-threatening.
Tc99m is the radioactive material used in four out of five of the 20 million nuclear medicine procedures performed in the United States every year, and it is now in critically short supply.
The 52-year-old nuclear reactor that produces close to half the world's supply of Tc99m has been shut down and may never reopen. Compounding the problem, Tc99m cannot be stockpiled because it has a short half-life. Doctors and hospitals that use this material must be re-supplied every 67 hours to have a continuous supply.
If Tim Russert, the late host of Meet the Press, had received a nuclear stress test instead of a less accurate echo stress test he might be alive today. If the 41st president, George H.W. Bush, had not been tested using Tc99m, his diagnosis of Graves Disease might have come later, after significant medical problems had progressed.
The Society of Nuclear Medicine will hold a press conference Monday at its annual meeting to discuss "the latest developments surrounding the international medical isotope crisis." Ironically, the Society announced yesterday that it would bestow its Nuclear Pioneering Award on the three men who innovated the heart test that uses Tc99m.
The award announcement read, "Millions of heart attack patients and other potential sufferers who have undergone a noninvasive nuclear imaging test with the isotope technetium-99 can thank [these] three innovators."
Worldwide, there are five old, high-energy Uranium 235 reactors that produce virtually all of the raw material from which Tc99m is made. They are in Canada, Belgium, South Africa, the Netherlands and France. These high-energy nuclear reactors run on Uranium 235, are 40 to 50 years old and have been closed down several times over the last few years.
Chalk River Problems Deal Huge Blow to Isotope Supply
The only reactor in North America that makes the raw material for Tc99m was closed in mid-May. It is located on the Chalk River, 115 miles northwest of Ottawa, Canada. There is no hard information about when or whether the Chalk River reactor will ever reopen. When it was closed, it was expected to be reopened in three months, then eight months -- and now some people -- including Jean-Luc Urbain, president of the Canadian Association of Nuclear Medicine -- question whether it will ever reopen.
The remaining reactors cannot make up for the shortage caused by the Chalk River shutdown, even while running at full capacity. To make matters worse, the South Africa reactor is now closed for scheduled maintenance, adding to the short supply of the isotope. And in July, when the South Africa reactor is scheduled to reopen, the Dutch reactor is scheduled to close for a few months.
The price of Tc99m has already increased significantly and it is sure to rise further in the coming months. Some Canadian news reports have claimed that hospitals could expect to pay $80,000 to $200,000 more per year for isotopes. More importantly, it may not be available when and where patients need it.
We must now take steps to preserve and increase the limited supply of this critical material. First, we must recognize there is a shortage of Tc99m that is likely to last for a long time. Second, we must acknowledge that the United States should control the availability of its supply of this product.
We need to get the most benefit from a limited supply by using it efficiently. Radioactivity continues around-the-clock. The mother isotope from which Tc99m is made does not sleep, and we must take advantage of this 24-hour-a-day characteristic by identifying hospitals where all patients within geographical regions can receive tests that are scheduled throughout the day and night.
We can maximize the benefit of a limited supply by standardizing dosages. Some tests that use TC99m in off-label applications have no standard dosage. We need to encourage the FDA to set standards for TC99m and accelerate approval of tests that use minimal dosages of this critical material as soon as possible.
Tech-99 Shortage Exposes Weaknesses in U.S. Medical System
We can create a U.S. supply of TC99m. The U.S. needs to allocate the funds necessary to convert an existing reactor or build a new reactor from which the source of Tc99m can be produced. This will free the U.S. from foreign sources and reduce delivery time of an isotope with a limited lifespan while eliminating international border inspections and delays.
The National Academy of Science and professional societies such as Society for Nuclear Medicine and the American College of Cardiology have called for building a U.S. reactor to produce this critical medical diagnostic for years. The best candidate for conversion of an existing reactor is the U.S. Department of Energy research reactor at the University of Missouri.
Finally, we must ask ourselves what other weak spots exist in the U.S. medical system. We take for granted the availability and affordability of most medical procedures and supplies in the U.S. Yet there is little public awareness of the vulnerabilities in our medical system. Over the past few years we have seen other surprise vulnerabilities -- to anthrax and influenza. It is unlikely that the shortage of Tc99m is the last problem we will encounter. Let's take the step of finding out where all the vulnerabilities are. Without such awareness, we become prey to a new, unexpected tragedy, as we were on 9/11 and the day Katrina hit New Orleans.
Steve Brozak is president of WBB Securities LLC, an independent broker-dealer and investment bank specializing in biotechnology, medical devices and pharmaceutical research. Larry Jindra, M.D., is director of research for WBB Securities LLC.