Natural Resources Committee on March 25th, 2010

[The Chair, Conservative, Leon Benoit]

Good morning, everyone.

We are here today for meeting 5 of our Standing Committee on Natural Resources to study the status of the NRU reactor and the supply of medical isotopes.

We have two panels today, one starting now and one at ten o'clock.

Our witnesses today from Lantheus Medical Imaging are Cyrille Villeneuve, vice-president and general manager, international; and William Jr. Dawes, vice-president, manufacturing and supply chain. Welcome.

We have by video conference from Sherbrooke, as an individual, Eric Turcotte, medical specialist in nuclear medicine, clinical head of the Molecular Imaging Centre of Sherbrooke.

We will go directly to the presentations in the order they are on the notice of the meeting. We'll start with Mr. Villeneuve.

Go ahead, please.

[Cyrille Villeneuve, Vice-President and General Manager, International, Lantheus Medical Imaging]

Thank you.

Good morning, honourable members. It is a pleasure to be here today. We are honoured to be invited to present to the committee on this important topic of nuclear medical isotope supply from an industry perspective.

My name is Cyrille Villeneuve, and I am vice-president and general manager for Lantheus. Bill Dawes is with me as the vice-president of manufacturing and supply chain.

In our time here today, I would like to give you a very brief overview of Lantheus Medical Imaging, our operations in Canada, and an update on our perspective on the nuclear medical isotope supply situation and its impact on our customers and the patients they serve. Both Mr. Dawes and I will be available to answer your questions afterwards.

Lantheus Medical Imaging is a global, privately held U.S. company, based in North Billerica, Massachusetts. We specialize in providing medical imaging diagnostic products for heart and vascular disease. The company has been a leader in the nuclear medicine industry for more than 50 years, most recently as a division of Bristol-Myers Squibb.

We brought to market pioneer medical isotope products such as thallium and Cardiolite, both of which are used in nuclear medicine to diagnose patients for cardiovascular disease. We believe they are the leading products serving the field today. Cardiolite is most widely used in cardiac imaging, and is the only technetium-labelled myocardial perfusion that has been used to image more than 40 million patients in the United States alone.

In addition to having ten products on the market, Lantheus has a rich pipeline of cardiovascular imaging agents in development for the detection of coronary artery disease and heart failure, and they are also based on medical isotopes.

Lantheus employs more than 600 employees worldwide. We are a fully integrated company with strong research and development capabilities, world-wide manufacturing facilities, a strong distribution network, and dedicated employees. As a global company, we have operations not only in the U.S. but also in Canada, Puerto Rico, and Australia.

In Canada, the head office of Lantheus Medical Imaging is in Montreal. Lantheus employs more than 80 Canadians, including sales and marketing staff, customer service representatives and radiopharmacy staff. Lantheus' international operations are managed from Canada, by Canadian staff.

In addition, Lantheus operates five radiopharmacies in Quebec City, Montreal, Mississauga, Hamilton and Vancouver. At those radiopharmacies, we prepare single doses, injection-ready doses, and we deliver them twice daily to nuclear medicine departments and clinics located near our facilities. We are also currently creating a network of radiopharmacy sites for positron emission tomography or PET, which will allow the distribution of PET products to Canadians.

As you may already know, Lantheus and other manufacturers need medical isotopes called molybdenum-99 in order to produce the daughter isotope called technetium-99m. Technetium-99m is the most used medical isotope in the world. On an annual basis, it makes up 82% of radiopharmaceutical injections used for diagnoses, which is over 18.5 million doses per year. Technetium is a critical component for many medical exams, including cardiac pool scans, brain scans, bone, kidney and various tumour scans.

At Lantheus Medical Imaging, we use technetium in our TechneLite generators. These generators are distributed to hospitals and radiopharmacies as sources of technetium for diagnostic imaging. Technetium is also used with Cardiolite in cardiac imaging, in order to assist in the diagnosis of coronary disease in those who might be suffering from it.

All this to say that a serious and extended shortage of medical isotopes can have serious repercussions on the health and well-being of a great many patients. The fact that the Chalk River NRU reactor has been closed for repair since May 2009 has had a significant impact on our operations and clients in North America.

Lantheus has had the privilege of having a very diversified supply chain, and we are doing everything possible to meet the needs of our clients and the medical community in Canada and the United States given the worldwide shortage of molybdenum-99.

The company has amended its production schedule in order to be ready, upon request, once the supply becomes available. We are working 7 days a week, 24 hours a day, and during holidays, in order to provide technetium generators to our clients. We also have the advantage of having cyclotrons, in the U.S., and we have greatly increased our thallium production so that doctors can have access to an alternative imaging product if they are unable to have access to technetium.

We are working in close cooperation with our clients in order to advise them of current and short-term supply, through direct communication and updates that we publish on our website. Furthermore, we are in almost constant contact with our customers and the medical community on the issue of logistics and distribution.

A number of nuclear medicine departments have amended their schedule, in order to maximize the quantity of technetium that is delivered to them. They are using alternative imaging products such as thallium. They are being forced to prioritize, sometimes postponing exams and sometimes even restricting the number of patients.

Since the beginning of the medical isotope supply shortage, Lantheus' Canadian operation has had one objective: to ensure that as many patients as possible receive their treatments or diagnostic tests. To achieve this goal, we have identified and implemented a number of actions.

We are working closely with Health Canada and the other companies that operate commercial radiopharmacies to ensure that technetium generators and unit doses are utilized equitably. We coordinate distribution of unit doses to all customers to make sure that all customers have some product for imaging.

We continue to collaborate with provincial health authorities to try to provide a similar level of available unit doses to health institutions that do not have radiopharmacy service.

To maximize unit dose availability, we have extended our radiopharmacy working hours to include evening and weekend production to maximize the quantity of technetium that is available.

We have substantially increased the availability of thallium, a product manufactured in a cyclotron, as an effective substitute to technetium-based cardiac agents such as Cardiolite. A vast majority of our customers have switched to thallium in periods of technetium shortage, assuring us that a baseline level of cardiac testing for patients has been maintained.

The significant efforts that Lantheus is making to develop a network of positron emitting radiopharmaceutical, or PER, manufacturing sites across Canada will not only have an important impact on the availability of existing Health Canada approved PET products for the Canadian health care community, but it will also prepare the market for the introduction of future innovative PER technologies and effective research PERs, such as sodium fluoride and other F18-based compounds that could be made available in a CTA environment.

The isotope supply crisis has also raised interest in other newer technologies and imaging modalities such as PET imaging. Lantheus already distributes GLUDEF, F18 fludeoxyglucose, a product used in the evaluation of patients with suspected cancers. We manufacture GLUDEF through a manufacturing partnership with the University of Sherbrooke. Lantheus is in the process of expanding the availability of GLUDEF to other parts of the country, and it is actively working on commissioning two other production sites, at the Montreal Neurological Institute and the Lantheus Mississauga radiopharmacy. Our strategy is to expand the PER pharmacy network to other parts of Canada to more broadly serve the needs of the Canadian medical community in the future.

Since our international operations are located in Montreal, Lantheus has a number of major clients in Canada. We are extremely determined to meet the needs of the Canadian market and we are doing everything possible to ensure that Canada receives the largest possible share of available technetium during this difficult time of reduced supply of medical isotopes. However, many of the solutions we have already discussed are short-term measures intended as stop gaps until isotope supply becomes accessible once again.

Having the NRU reactor come back online would greatly assist in reducing the impact of the world isotope shortage, particularly in North America. Since the HFR reactor in the Netherlands was closed at the same time as the NRU reactor, the medical isotope shortage is being felt all the more, which demonstrates the importance of having access to accessible and diversified sources of supply throughout the world as well as the importance of cooperation between industry, regulatory bodies and project promoters.

We believe that the short- and medium-term solution to ensuring stable medical isotope supply for Canadians is to repair the NRU reactor as quickly as possible and to provide financial support to efforts to ensure that the licence is renewed until 2016.

At Lantheus Medical Imaging, we are extremely determined to work with our clients and their patients, our suppliers and government agencies in order to ensure a more stable supply of medical isotopes in both the short and long term for the medical community and for patients, for whom we are all working.

Thank you for giving us the opportunity to speak with you today. We greatly appreciate this privilege and we would be pleased to answer any questions you may have.

[The Chair, Conservative, Leon Benoit]

Thank you very much, Monsieur Villeneuve, for your presentation.

You'll both be available for questions, I understand.

We'll go now to a video conference with Eric Turcotte, medical specialist in nuclear medicine and clinical head of the Molecular Imaging Centre of Sherbrooke. He's appearing as an individual.

Go ahead please, Mr. Turcotte.

[Dr. Eric Turcotte, Medical Specialist in Nuclear Medicine, Clinical Head of the Molecular Imaging Centre of Sherbrooke, As an Individual]

Thank you very much, Mr. Chair, for the invitation.

I come here wearing many hats: a doctor specializing in nuclear medicine, a professor teaching residents in training in nuclear medicine and radiology and producer of isotopes. I am also a doctor who takes care of patients. Thank you for the invitation. Can you hear me?

[The Chair, Conservative, Leon Benoit]

Go ahead, please. Everything is great.

[Dr. Eric Turcotte]

Good.

My presentation will be quite brief, so as to allow a lot of time for questions. I imagine that you have many.

For almost a year now, we have been dealing with the isotope shortage in Sherbrooke and throughout Quebec. Approximately 30% of the shortage is a result of the shutdown of the NRU reactor. There have been benefits for the health care system, but it has also caused problems.

With regard to the benefits, I am referring mainly to the optimum usage of medical isotopes. Isotopes were no longer wasted if a patient failed to show up, we called the next person on the waiting list. One dose could be cut in half, which allowed it to be used for two patients. Since this product has a short life and we had it evenings and even weekends, we were able during that same period to really maximize usage. That is the positive impact of the shortage.

However, the alternatives created in response to the shortage are problematic. We are talking a lot about thallium, which is used in myocardial perfusion. We are using it as a substitute for MIBI, but it is not the best substitute. In comparison to the radioactive tracer, this product generates a much higher dose of radiation in patients and it is not as effective in overweight individuals. For people who are very overweight, the images generated are of lower quality. Ultimately, this has consequences on the health care system.

Other technologies can also be used, such as magnetic resonance and CT scans. However, even if these technologies are available, they are relatively costly. The use of such technologies has already been maximized. If we transfer people needing nuclear medicine exams to magnetic resonance imaging, for example, we're only moving the problem around. The equipment cannot deal with the surplus.

On the other hand, many new alternatives have been tried. Today, there is a lot of interest in positron emission tomography. A number of specialists and I believe that it is really the technology of the future. The problem is that, approximately 31 of these devices are available in Canada and 15 of them are in Quebec. The geographic distribution of this technology is not sufficient. It can be very well used in Quebec. We use it a lot. I would say that, in Quebec, the crisis has likely hit us less, given the availability of these positron emission tomography machines. Thanks to them we can do bone scans, myocardial perfusion studies and many other examinations. In my opinion, it is really a technology we should look to and we must encourage its development.

Doctors believe that patients should never be deprived of an examination. The NRU alone is responsible for 30% of the shortage in global production, but no patient has really suffered from the shortage. Some exams have been postponed, but everyone has been able to have an exam and no one has really suffered.

However, the Dutch reactor is now being repaired and the isotope shortage has reached 60%. As a result, the shortage will be felt, and I truly fear that some patients will not be able to get an exam in time. We will rack our brains and try to find solutions, but I can tell you that, at present, there are few solutions. Furthermore, we don't really have the time to find new ones.

The floor is now yours.

[The Chair, Conservative, Leon Benoit]

Merci, monsieur Turcotte.

Now we go to questions, starting with the official opposition, for up to ten minutes.

Go ahead, please, Mr. Regan.

[Geoff Regan, Liberal, Halifax West, NS]

Thank you very much, Mr. Chair.

[The Chair, Conservative, Leon Benoit]

It's been a while since we've had questioning in this committee.

[Geoff Regan, Liberal, Halifax West, NS]

On behalf of my colleagues, I want to thank our witnesses.

[The Chair, Conservative, Leon Benoit]

Just before you start, Mr. Regan, I would like to thank both parties for their presentations. I think this information really is helpful for the study the committee is doing. With the questions, we'll get a lot of the answers we're looking for.

Go ahead, Mr. Regan.

[Geoff Regan, Liberal, Halifax West, NS]

My seven minutes starts now, right?

[The Chair, Conservative, Leon Benoit]

It starts now.

[Geoff Regan, Liberal, Halifax West, NS]

Thank you.

We're hearing reports this week, as we've heard reinforced this morning, of dramatically dwindling supplies of medical isotopes. We're also hearing numerous reports coming out of testing for cancer and treatment for heart disease being cancelled or postponed. We can imagine what a dramatic impact this must be having on patients and their families.

As recently as last Friday, when I asked the Conservative government in question period, they continued to deny that there's a growing crisis in relation to medical isotopes.

You may be aware that Dr. Jean-Luc Urbain, who is president of the Canadian Association of Nuclear Medicine, said the supply of isotopes will slip to about 25% on average, and of course the patients will feel the crunch. He's in fact talking about having to cut service. We've heard a bit of that this morning as well.

The Society of Nuclear Medicine in the United States is describing the shortage as “one of the most significant disruptions ever”, and supplies are expected to be scarce in Canada for about two weeks, according to nuclear medicine specialists. Perhaps we can hear more on that.

Hamilton Health Sciences experts say they expect to see the isotope supply drop to 15% by Friday.

The Ottawa Heart Institute has cancelled seven patients who were booked for appointments today: “Hospitals are being affected to varying degrees depending on their arrangements with isotope suppliers.”

So I guess I'd like to hear more from Mr. Turcotte.

First, I would like Dr. Turcotte to tell us about his personal experience, in his position, and the challenges that he and his colleagues face in managing this crisis.

[The Chair, Conservative, Leon Benoit]

Monsieur Turcotte.

[Dr. Eric Turcotte]

Thank you.

That is an excellent question. There are major challenges. At present, we are being asked to do the impossible with a bare minimum. Among the major challenges, there is the fact that the shortage varies from one day to the next. It is extremely difficult to schedule exams, even within a 24-hour window. Since I don't know how much radioactive products my department will receive the next day, it's difficult to tell a patient the night before to get ready for a given exam. It's really a logistics problem. Sometimes patients are asked to come to the hospital, but then there isn't any radioactive product to use for their exams. That is really the number one problem.

Second, there is the issue of priority. When you only have 15% or 20% of a component needed for exams, it's clear that the most urgent cases get priority. However, it is difficult to determine which cases are the most urgent. In some cases, it may be a matter of life or death. We have to rely on common sense. It is essential to always determine whether the patient's exam can be postponed a few days or whether it is really essential, for example if the patient is about to undergo surgery or chemotherapy in the next few hours. It's a logistics issue. In order to compensate for this, we need to be able to operate on evenings and weekends, to ensure that the department is open when the product is available.

Third it is a matter of looking at the choices that can be provided to patients. The myocardial perfusion can be done to check blood vessels. Coronary angiographies or angiograms allow us to see blood vessels. The main advantage of nuclear medicine is that these exams are not invasive. Injecting radioactive products is the most invasive part of our exams. However, the proposed alternatives are sometimes more invasive. It may be necessary to put a patient on a gurney and use special injection products. Ultimately, the alternative may carry a higher risk of mortality than the nuclear medicine exam. Furthermore, diagnostic sensitivity can be decreased when using alternatives.

We provide other choices while ensuring that they will enable good diagnostic results and that they will not be harmful, while trying to do the utmost for our nuclear medicine patients. This is a daily challenge.

[Geoff Regan, Liberal, Halifax West, NS]

How much longer do you think you can continue to operate in this way? What do you think of the fact that the AECL continues to announce new delays with regard to the NRU program in Chalk River? Today, for example, I saw the following occur for the first time: the AECL announced that it would announce progress achieved later in the day.

Why are they announcing that they're going to make an announcement? It makes me somewhat fearful that the news will be very bad.

[Dr. Eric Turcotte]

The question is also very relevant.

Since the situation began a year ago, hospitals have learned to live with the 30% shortage created by the shutdown of the NRU. Clearly, this has generated increased stress for staff and doctors, because operating hours vary widely. In the past year it was possible to practise very good medicine and to take good care of patients. The current problem relates to the Dutch reactor's breakdown, which has added an additional 30% shortage, which really hurts. The delicate balance that we had achieved at 70% of operating capacity has dropped to less than 30%. This is a major problem.

With regard to the NRU's repair, clearly, the fact that its repair is being done at the same time as that of the Petten reactor means that the situation remains problematic. At present, things are even worse, since maintenace work is being done on other nuclear reactors during the week. This has worsened the crisis for us. In reality, as long as there is a shortage at the two major reactors, the situation will remain extremely precarious with regard to our exams.

As for announcements about the progress in repairs to the NRU reactor, honestly, in medical circles, it has almost become a joke to get an AECL report talking about 30%, 35% or 40%. Medically speaking, this is irrelevant. We only want the reactor to become operational again. The repeated postponements that have been announced since January have meant that we no longer take AECL seriously.

We continue to hope that the reactor will resume operations by fall. It is likely more realistic to think that it will happen in the fall rather than in the spring.

[The Chair, Conservative, Leon Benoit]

Thank you, Mr. Regan.

Madam Brunelle, for up to seven minutes. Go ahead, please.

[Paule Brunelle, Bloc, Trois-Rivières, QC]

Thank you, Mr. Chair.

I want to thank our witnesses for coming.

You know, this situation is of great concern. Every week, we hear about the sick and people who are worried.

Dr. Turcotte, you said that examinations were continuing but that you could cite cases where some exams were postponed, mainly for seniors, in your region. It remains of grave concern no matter who it is.

Mr. Villeneuve, you said that the Chalk River reactor shutdown had a significant impact on you. You told us how you had managed to adjust to the situation. I would like to have more details on the consequences.

I would like to ask you another question. You said that your thallium production had increased. Dr. Jean-Luc Urbain, President of the Canadian Nuclear Medicine Association, told us that this was a 20^th century technology, meaning a technology that could be used for now but that was nonetheless out-of-date.

How do you see the future of thallium? Is it really simply an alternative or do you think that, in the long term, this will be a future solution, if the shortage continues and Chalk River remains closed for a long period of time?

[Cyrille Villeneuve]

From May until recent weeks, the impact has been approximately 50% of Canadian supply. Now, with the shutdown of the Dutch reactor, it is becoming increasingly difficult to predict exactly what the impact will be in coming weeks. So, the longer this shortage continues, the fewer alternatives we have. We do not have a plan B or a plan C. So we are at the mercy of various reactors.

I can tell you that we are looking everywhere to try to find everything available. To date, we have managed to find a significant share, between 40% and 50%. However, we are not producing molybdenum ourselves.

With regard to thallium, it's really a substitute product, recommended by Health Canada. So, at the request of doctors who want to use it, we reactivated our cyclotrons and we are meeting the demand... We feel that this is temporary, while we wait for technetium to become available once again.

I think that Dr. Turcotte gave a very good explanation of the advantages and disadvantages of thallium. I think that his medical expertise is far superior to mine. So, if you need other comments on this matter, I would prefer that he answer.

[Paule Brunelle, Bloc, Trois-Rivières, QC]

Good day, Dr. Turcotte. You said that thallium is not ideal because it is less effective. Some doctors have told us that some products cannot be given to children, for example, or may have certain effects, because too much energy is emitted or something like that. Is thallium one of those products?

[Dr. Eric Turcotte]

In my opinion, thallium is not an ideal isotope these days for nuclear medicine. It is however an acceptable alternative. It exposes patients to too much radiation. Exams done using that isotope emit more radiation than any other in nuclear medicine. To give you an example, a regular bone scan exam results in dosimetry of 8 millisieverts, meaning the dose absorbed by the patient. Eight millisieverts is acceptable. A cardiac exam using thallium will result in an approximately 30 millisieverts dosimetry, which is quite high.

Furthermore, that exam produces a lot of radiation and the image quality is not what we can expect from a nuclear medicine test today. The resolution is not as good and when patients are even slightly overweight, it becomes extremely difficult to see the heart. In such cases, diagnostic errors may occur, when we use thallium. That said, for patients who are thin and underweight, it remains an acceptable radioactive tracer that provides good results in those conditions. However, if a patient is even slightly overweight, I would rather use positron emission tomography, using myocardial perfusion agents. In such cases, these agents have half-lives of approximately 10 minutes. So this must be done locally, on site, for patients. This must be used on site. This makes the technology extremely inaccessible.

[Paule Brunelle, Bloc, Trois-Rivières, QC]

I would like you to tell me a bit more about positrons. You are telling us that this may be a good solution for Quebec because it has 15 of the 30 devices. What kind of technology is this? Where can we obtain a supply of positrons? Tell me more please.

[Dr. Eric Turcotte]

The beauty of positron technology is that, first of all, it does not depend on nuclear reactors whatsoever. To produce isotopes, we need a cyclotron. Hospitals and universities have one. There is one at the Molecular Imaging Centre in Sherbrooke, one at the Montreal Neurological Institute, one belonging to a private company called Pharmalogic in Montreal. There are also several in Ontario. This equipment uses electricity. So we establish a target, turn on the electricity to the cyclotron and isotopes are produced.

The disadvantage of isotopes produced using the cyclotron is that these isotopes have short half-lives, half lives of 10 minutes, 20 minutes, 110 minutes, 3 hours. This is far from technetium's 6 hours or even further from molybdenum's 66 hours. As a result, these isotopes need to be produced each day they are used.

What else do we need, in addition to cyclotrons, for positron imagery? We need special equipment. We cannot use the SPECT devices, the gamma-cameras that use technetium, in order to use the positron. This means that the some 600 SPECT devices available in Canada cannot be used with positrons. We are really limited to the 30 devices available. These are relatively costly devices. We are talking about technology worth approximately $2.2 million. SPECT technology, a 2010 technology, which uses technetium, costs $1.1 million. The PET device is only twice as expensive.

The results are far better in terms of diagnoses. Exams are much shorter. A bone scan exam using nuclear medicine may last four hours. The patient must then spend four hours at the hospital in order to undergo the exam. The same exam done using sodium fluoride positron technology will last 45 minutes. So there are a number of advantages, including better resolution, better diagnoses, much less time spent in the hospital, and many more patients can be diagnosed each day. That is why this technology, in 10 or 15 years, will become the preferred technology. However, we are not there yet. We do not have enough cyclotrons.

Furthermore, I would like to stress that these famous cyclotrons can produce isotopes using positrons. The cyclotrons are really helping us survive this shortage to some extent. They are producing thallium and gallium-67. The nuclear reactor is producing iodine-131 and technetium-99, by using molybdenum and nuclear medicine. The remaining isotopes are produced using cyclotrons. So it is a good hybrid technology that can produce old isotopes one day and new ones the next.