Health Committee on Nov. 23rd, 2009

[The Chair, Conservative, Joy Smith]

Good afternoon, ladies and gentlemen. I want to welcome you to the health committee. I am Joy Smith, the chair of the committee. We're very pleased to have you here today.

Pursuant to Standing Order 108(2), this is a briefing on the health implications of the supply of radioisotopes.

Today we're going to ask each organization, in turn, to make a presentation. Each person will have a five-minute presentation.

We have before us today Dr. Jean-Luc Urbain, president of the Canadian Association of Nuclear Medicine. Welcome, Dr. Urbain.

We have Dr. Anne Doig, president of the Canadian Medical Association. Thank you, Dr. Doig .

We have, from the Ontario Association of Nuclear Medicine, Dr. Christopher O'Brien. Welcome, Dr. O'Brien.

From the New Brunswick Cancer Network, we have Dr. Eshwar Kumar. Welcome to you. I welcomed you a little earlier, but I'll welcome you again, Doctor.

And from the European Association of Nuclear Medicine, we have Patrick Bourguet, who is president-elect of the European Association of Nuclear Medicine.

We also have Dr. Alexander McEwan, who has joined us. I looked up and there you were, Dr. McEwan. Thank you for being here. Dr. McEwan is a special adviser on medical isotopes to the Minister of Health.

We welcome you here. As I said, you'll each have a chance. We're going to start with Dr. Anne Doig from the Canadian Medical Association, who will have a five-minute presentation. Following all of your presentations, we'll then go into questions and answers.

Dr. Doig, welcome.

[Dr. Anne Doig, President, Canadian Medical Association]

Thank you, and good afternoon, Madam Chair. It is my pleasure to address the committee as part of its monitoring of the situation related to the supply of medical isotopes.

As a family physician, I am not an expert in nuclear medicine, but I do refer patients for diagnostic and treatment services that require the use of medical isotopes.

First and foremost, I want to note that the CMA is proud of the efforts and dedication of health care providers from across the country who have stepped up to meet patients' needs during this ongoing stressful and demanding time. Through their concerted efforts and those of the industry and governments, the system appears to be coping. Patients are receiving needed diagnostic and treatment services, either through radiopharmaceutical models or their alternatives. However, there are reports of sporadic adverse events, as has been the case since the beginning of this situation. These include delays of 48 to 72 hours and suboptimal imaging due to the extensive use of thallium-201 rather than technetium-99m, which is in short supply.

The CMA and representatives from the nuclear medicine community continue to work with Health Canada to mitigate the impact of the shortage of medical isotopes. Scheduling appropriate care commensurate with the expected supply of isotopes has been aided by the efforts of Lantheus and Covidien, suppliers of generators and radiopharmaceuticals who regularly share vital production information with the nuclear medicine community. This has improved communications and allowed for the better predictability of supply than had been the case last May and June.

Lest you interpret my comments to mean all is well, let me be clear. Much is being done, but the current situation is neither optimal nor sustainable, and there appears to be no long-term plan. Canada's physicians are concerned about the toll the current shortage of isotopes is taking on the health care system as a whole. In particular, the resulting increased demand on resources, both human and financial--and especially now in the midst of a pandemic--is not sustainable. Therefore, we have called upon governments to invest in a five-year action plan that includes an emergency fund to increase the use of positron emission technology and the production of associated radiopharmaceuticals across Canada.

At our annual meeting this August, Canada's physicians expressed their concern by passing a series of motions calling for government action. This action included demands that the federal government retain Canada's leadership and ability to produce and export medical isotopes and reconsider its decision to withdraw from their production. The motions also called for the appointment of an international independent expert panel to thoroughly assess the decision to abandon the MAPLE 1 and MAPLE 2 nuclear reactors at Chalk River and promptly release the conclusions and recommendations of the panel to the public.

Our delegates also demanded that the federal government conduct open, meaningful, and ongoing consultations with nuclear medicine physicians and their respective national associations on any and all federal decisions directly affecting the supply of medical isotopes. Concern was expressed that decisions have been and will continue to be made for political and financial expediency without taking into account the medical ramifications of those decisions.

We appreciated having the opportunity to participate in discussions with the Expert Review Panel on Medical Isotope Production appointed by the Minister of Natural Resources. While it is anticipated the panel will report to the minister by the end of this month, we do not know when that report will be made public and how long it will take to move recommendations to action.

Canadian physicians also urge the federal government to immediately invest in research in basic and clinical science to find viable alternative solutions to the production and use of technetium-99m. The announcement of $6 million for research into alternatives to medical isotopes through a partnership between the Canadian Institutes of Health Research and the Natural Sciences and Engineering Research Council of Canada is a good start. We must emphasize that bench-to-bedside research is critical. There must be a clinical translation of new technology to the provision of care.

To conclude, the CMA remains concerned about health care providers and the health care system's ability to sustain the current shortage, Canada's ability to ensure a long-term stable and predictable supply of medically necessary isotopes, and our lack of contingency planning for the next shortage. The CMA will continue to work with all involved to ensure Canadians have access to the best possible care and treatment.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Doig.

We'll now go to Dr. Jean-Luc Urbain.

Please make your presentation.

[Dr. Jean-Luc Urbain, President, Canadian Association of Nuclear Medicine]

Thank you very much, Madam Chair.

Madam Chair, honourable members of the committee, on behalf of the Canadian Association of Nuclear Medicine or CANM, I would like to thank all of you for giving our organization the opportunity to appear in front of the Standing Committee on Health and to report back to the committee on the effects of the isotopes shortage on Canadians. As you know, the CANM is the national voice of the nuclear medicine physicians across Canada and the 2 million patients that they serve every year.

Since the first shutdown of the NRU reactor in December 2007, the Canadian Association of Nuclear Medicine has worked relentlessly with all stakeholder organizations involved in the field of nuclear medicine.

The NRU reactor has now been out of service for seven months. The impact on Canadians and the Canadian nuclear medicine community has been very significant. It will also have a lasting effect on patients' health, the practice of medicine in Canada and across the world, the Canadian and international nuclear medicine community and the Canadian nuclear technology.

Over the past seven months, the weekly supply of technetium across Canada has varied between zero and 100%, with an average of 50% to 70% depending on the geographic location and the suppliers. Nuclear medicine professional technologists, physicists, radiopharmacists, support personnel, and physicians across Canada have worked tirelessly to accommodate the needs of their patients. By working double shifts, reorganizing the examination around the timing of the delivery of the spare technetium available by using different protocols and isotopes, and by spending an enormous amount of time over the phone contacting patients and referring physicians to reschedule studies, and also by not providing on-call services, our committee was able to minimize the effect of the shortage of isotopes on the Canadian patients.

Through that very delicate balancing act and at the expense of a significant increase in operational costs, the cancellation of patients' tests has been limited. This extraordinary and unsustainable effort of our community, the unreliability of technetium supply and the uncertainty of medical isotopes production in Canada have already generated serious and damaging consequences. The enrolment of students, mainly technologists and physicians, in nuclear medicine sciences is down, layoffs of technologists have been witnessed and nuclear scientists are contemplating or are moving south of the border.

By its unique ability to investigate the function of cells, tissues, and organs, the isotopes enable the detection and treatment of disease at the molecular level before it becomes evident anatomically and before patients become symptomatic. You have available the schematic that we have drawn to your attention. The earlier the diagnosis of the disease is made, the better the chance of a cure for the disease. I would hope you were given reference one and two related to the early diagnosis of cancer and cardiovascular disease. The CNM is extremely concerned by the significant decrease--from 10% to 25% depending on the region--of patient referral for nuclear cardiac and oncological tests. Without early detection, assessment, and treatment, cardiac disease and cancer progress to a point where patient well-being is severely compromised and morbidity is higher regardless of management, not to mention the financial burden on the health care system in society, which is becoming enormous.

Many of us attended the annual meeting of the European Association of Nuclear Medicine that was held in September in Barcelona. The annual EANM meeting is one of the largest annual gatherings of nuclear medicine professionals in the world. This year, more than 5,000 people attended the conference.

It is not an understatement to note that the credibility of Canada and its ability to build up nuclear reactors and produce medical isotopes has been totally shattered. Also, our colleagues from Europe simply do not understand why Canadians across Canada do not have equal access to technetium and the newer isotope and technology like FDG and positron emission tomography. Health care professionals and patients alike are now really questioning the relevancy of the Canada Health Act, and particularly its provision of portability and its criterion of comprehensiveness. It is difficult and shameful to have to admit to our international colleagues that in 2009 Canada is now delivering health care services with 20th century tools.

As you probably know, many western European countries have decided to continue to rely on their nuclear reactors technology for another 25 years. France, for instance, as Dr. Patrick Bourguet may mention, is currently building a reactor to produce medical isotopes in the south of the country and the European countries have reached an agreement to build up a replacement to the Petten reactor in Holland.

By refusing to investigate a situation of the MAPLE reactor by allocating $22 million to a 50-year-old reactor in Hamilton and by giving away $6 million or maybe $12 million to fund projects like the production of technetium with cyclotrons in order to mitigate, five to ten years down the road, the crisis, the current shortage of technetium, we have really become the mockery of the international medical and scientific community.

The CANM can only encourage members of this committee to consult the reports...

[The Chair, Conservative, Joy Smith]

Dr. Urbain, I'm sorry to interrupt you, but you're way over your time. We want lots of time for questions.

[Dr. Jean-Luc Urbain]

I'm sorry. I thought it was 10 minutes, as in the past.

I just want to reiterate our offer to collaborate with all stakeholders to make sure Canadians get what they deserve in terms of their health care system.

[The Chair, Conservative, Joy Smith]

Thank you so very much.

Now we'll go to Dr. Christopher O'Brien.

[Dr. Christopher O'Brien, President, Ontario Association of Nuclear Medicine]

Thank you, and good afternoon.

Nuclear medicine offers unique insights into disease that are not achievable with either CT or MRI alone. It is through a combination of functional imaging, which nuclear medicine excels at, and it is in conjunction with anatomic imaging such as CT and MRI that patients obtain the most benefit. Nuclear medicine also plays a vital role in the detection and treatment of various diseases such as cancer, heart disease, thyroid disorders, and blood clots in the lung, just to name a few.

Even though most of our conversation has been about cancer and heart disease, our patients range from newborns to people over 100 years old. So the impact of the medical isotope shortage is profound, affecting every Canadian who needs a nuclear medicine procedure. In order to accomplish this role, a steady supply of reasonably priced medical isotopes is essential. If medical isotopes become too expensive without the appropriate operational funds being transferred to the various hospitals and clinics, the effect would be the same as--

[The Chair, Conservative, Joy Smith]

Doctor, could I ask you to slow down just a little bit because the interpreters can't keep up to you.

[Dr. Christopher O'Brien]

Oh, I'm very sorry.

[The Chair, Conservative, Joy Smith]

That's okay. It's very interesting.

[Dr. Christopher O'Brien]

So the effect would be the same as not having any medical isotopes at all. We're beginning to see rationed access and staff lay-offs, and departmental closures would be a potential if the costs become incremental. The effect of this will not be in the urban centres; the effect will be in the smaller community hospitals across Canada that rely on nuclear medicine services, and it will have a patchwork but definite impact. If this were to occur, the negative impact on patient care would be profound, as we've heard before.

Not only are we looking at the present, but we have to look at what nuclear medicine will offer in the future in the role of personalized medicine. This looks at the ability to tailor treatment and diagnosis based on the characteristics of the disease process. In order for this to occur and in order for Canadian patients to access this, we will need a very strong nuclear medicine capacity in Canada that will be supported by research into the development of medical isotopes as well as pharmacological agents to allow us to position patients in a way that they can garner good access to medical care in a timely fashion.

There has been discussion in the past about the need for medical isotopes. This has been a discussion we've heard both in the lay press and through various committee meetings. In North America there has been a valuation for nuclear cardiology that between 2008 and 2012 we anticipate about a 46% increase in demand for nuclear services just to assess the heart. With general nuclear medicine and positron emission tomography, we're looking at an approximate 11% increase in demand over that same time period. This is just in North America.

If one takes into account the potential increases we will see in the Middle East, Africa, China, India, and South America, there will be a worldwide increase in demand for medical isotopes. If the Canadian infrastructure is not in place to ensure that Canada still plays a role in development, we will be competing with larger markets to ensure our Canadian population has access to nuclear medicine services. This is vital. This is not just looking at how we will compete in Canada but how we will compete in the world. If we're not positioned, then we may not do well.

What is the reason for this increase? Nuclear medicine is a procedure that is exceedingly cost-effective. It is one of the cheaper diagnostic procedures when compared with CT and MRI interventional procedures. The unique diagnostic capability and the impact on patient care is almost as if it's a beautiful thing coming together. We have a good technology that has impact and that is cost-effective.

Canada has traditionally been a leader in medical isotope production and distribution. In light of world trends, I think we have to continue this. Canada must be positioning itself to take the leadership role in this growth industry. Unfortunately, the message Canada has been sending over the last six months is that it may not be actively involved in this. The cancellation of the MAPLE reactors had an impact that caught us completely off guard. Statements from the Prime Minister's Office stating that by 2016 Canada will no longer be in the medical isotope business are sending the message nationally, provincially, locally, and internationally that Canada is well on its way to becoming a bit player on the world stage rather than being the leaders we have been for the last 50 years. This is a sad reflection.

What is our current status? Right now we are entirely dependent on foreign sources of medical isotopes. As mentioned, the various companies have done a good job.

[The Chair, Conservative, Joy Smith]

You are over time your now, Dr. O'Brien, so if you don't mind, would you please wrap up?

[Dr. Christopher O'Brien]

Yes. I think one of the important things we have to look at with the cost increase is that we need a one-time cost transfer to hospitals and clinics to address the surcharges we're facing. We need a nuclear medical equipment fund to allow modernization of our platforms to use less medical isotopes and to reduce the exposure of our patients to procedures. We need a PET scanning program and we need to re-evaluate the abandonment of the MAPLE projects.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. O'Brien.

We'll now go to Dr. Eshwar Kumar, from the New Brunswick Cancer Network.

[Dr. Eshwar Kumar, Co-Chief Executive Officer, Department of Health New Brunswick, New Brunswick Cancer Network]

Good afternoon. Thank you for inviting me to appear before your committee.

I am the co-CEO of the New Brunswick Cancer Network, which is a division of the Department of Health in the Government of New Brunswick. I was also the head of the cancer centre in Saint John, New Brunswick, where I am still an active clinical radiation oncologist. Wearing both hats, as a civil servant overseeing the cancer system in New Brunswick, and as a practising clinical oncologist, I have a fairly unique perspective on the impact the radioactive isotope shortage has had.

My patients and their families are understandably very anxious when I first meet them. The cancer journey from diagnosis through investigations to treatment is not an easy one. It carries a huge emotional and physical burden. As their oncologist, my task is to help them through their journey and ease their burden as best I can.

The news of a shortage of radioactive isotopes causing possible delays in completing staging investigations, formulating treatment plans, and commencing treatment has undoubtedly added to this anxiety and emotional stress. However, at least in the New Brunswick situation, thanks to the dedication and efforts of the staff in nuclear medicine departments who have worked many long hours and weekends, the impact on patients has been kept to a minimum.

While there has been inconvenience to patients at times, the staff have done well to manage the shortage and avoid any significant delays in commencing treatment. I know that the uncertainty regarding the supply from week to week adds to the stress in the workplace, but others more involved in managing nuclear medicine departments would be better placed to comment on that.

As a clinician, however, I am pleased that my patients have been able to have their investigations and treatments within a reasonably acceptable timeframe. However, a situation such as this makes one review one's own clinical practice and forces one to become more selective in requesting these investigations, while at the same time ensuring that treatment is not compromised in any way. So while the situation is not ideal, we have coped so far.

From a provincial perspective, the tremendous cooperation and collaboration between the health zones and authorities in the province have been very satisfying. Resources and information have been shared to ensure that patient needs have been met. Again, the dedication of the nuclear medicine staff cannot be overemphasized.

As the New Brunswick representative on the FPT working group on isotopes, I would like to acknowledge the tremendous support we have received from Health Canada. The convening of weekly teleconferences, the regular updates in the supply situation, and their efforts to ensure that suppliers give us forecasts for the immediate future have helped us with planning at the local level. I would also like to acknowledge my colleagues from the other provinces in this group for so freely sharing information on supply and methods to help cope with and manage the shortage. It has been extremely helpful.

In summary, I'm pleased to say that up to now we have coped with the situation well, but I remain anxious about how we are going to face the future as the uncertainty about the supply continues. This perpetual state of crisis is not healthy.

Thank you.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Kumar.

Now we'll go to Dr. Bourguet via video conference. Dr. Bourguet will be making a five-minute presentation. Following that, we'll go to questions and answers.

Dr. Bourguet, please begin now.

[Dr. Patrick Bourguet, President Elect, Professor of Nuclear Medicine, European Association of Nuclear Medicine]

Good afternoon and thank you very much for having invited me to appear before the Standing Committee on Health.

I would like to begin by saying that as I am European, I do not want to comment on Canadian domestic policy but speak to you rather about the European situation through testimony or any questions you may wish to ask me.

First, the current technetium crisis is not a problem that is unique to Canada nor is it unique to Europe. This is a global problem but it is especially affects Canada, Holland, Belgium and France, if one excludes South Africa because of its low molybdenum production. It is mainly these four first countries I mentioned that are directly affected because they are the ones up until now who have been producing most of the molybdenum that is used in the manufacture of technetium generators.

The first point I would like to raise, and that has already been raised by colleagues, is the interest in technetium. There has been some debate on the importance of technetium exams as part of a medical strategy. I think that debate is no longer taking place. For reference purposes, I would like to suggest an excellent report that was published by the European community on June 30, 2009. This report provides an update on the importance and relevance of these types of exams.

There is also an audit that was produced by the Dutch government that is now available on the European Association website and that looks into the forecasted increase in the European zone of technetium exams. Of course it does not take into account the situation in emerging countries, as our colleague Professor Urbain said earlier. Today there is very clearly a problem of supply in technetium 99 M and this is truly a public health problem.

What is the current situation in Europe? It is the same as yours, because we depend on the Canadian reactor, and for the most part, on the Dutch reactor. The latter is still operating but it will have to stop operating in order to allow for significant maintenance work next spring. Therefore, there will truly be a supply crisis because both the Canadian reactor and the Dutch reactor will have been shut down.

It is estimated that approximately only 30 per cent of global needs will be met during a three- to four- week period. That is truly a problem. On the European side we are trying to find an industrial solution, but this is an European industrial solution whose purpose, contrary to the initial Canadian MAPLE project, is not to meet global needs—I think it is very important to make this clear. It is important to find transatlantic solutions that will secure technetium 99 M supply on both sides of the ocean.

In Europe you currently have a moderate crisis. It was more severe last year when there were periods during which the supply varied from 20 to 80 per cent depending on the country. Some members of the European community were able to use Russian supply or former Soviet countries' supplies, because at the time there was generator production. However, that is not currently authorized on the European market.

Very clearly, our situation is somewhat different from that of Canada because we have a greater number of suppliers for generators. Furthermore, one of our current advantages is that our industrial stakeholders are members of an association, the AIPS, that is a credible and active player in the crisis management, a player that can sit down with public authorities, representatives from reactors, and think-tanks like our own and attempt to find a plan.

That is what Professor Urbain was saying earlier, that there is a solution...

[The Chair, Conservative, Joy Smith]

May I interrupt you for just a moment, Dr. Bourguet? Your presentation time is up, so if you wouldn't mind concluding, we'll go to questions and answers.

[Dr. Patrick Bourguet]

No problem. I can answer questions now because I think I have covered the most important points.

[The Chair, Conservative, Joy Smith]

Now we'll go to Dr. Alexander McEwan .

[Dr. Alexander McEwan, Special Advisor on Medical Isotopes to the Minister of Health, As an Individual]

Madam Chair and honourable members, thank you for the opportunity of appearing before the committee again. I am grateful for this chance to give you an update of where I perceive we stand in dealing with this issue. I will remind you that I also appeared before the Standing Committee on Natural Resources on October 19. I will repeat the statement that I made there, that the system is coping. That coping is fragile, and the term that I used was “stressed stability”, which I think provides a fairly good summary of how we are managing.

If I can have your indulgence, Madam Chair, I would like to give a brief overview of where we've come from and then look a little bit to the future.

I think we need to recognize in particular two groups of people who we really have impacted by this and who have responded well. The first is our patients. We have been able to offer tests to all those people who need them, but patients have been asked to attend at odd times. They've been asked to change appointments, and I think we need to recognize the stresses we have placed upon them.

Second and most importantly, I think this crisis has been managed through the very hard work and flexibility of the community, in particular of our technologist colleagues. They have changed shifts, they have changed working practices, and they have changed the hours at which they come in, and I think we owe the Canadian Association of Medical Radiation Technologists a vote of thanks for all they have done.

I think we also need to recognize that the generator manufacturers have really gone above and beyond the call of duty in sharing, in accessing alternative sources of molybdenum and of ensuring that there is some cohesion around the way in which generators are supplied.

We also need to recognize the efforts of Health Canada. They have facilitated regulatory approvals. I think of the Australian OPAL reactor molybdenum approval. The guidance document, upon which we have met and discussed on many occasions, has proved very helpful in enabling institutions and departments to change practice in a way that has really helped deal with the crisis. And most importantly, it has been sharing the supply forecasts and sharing the supply actualities with provincial and territorial colleagues and with individual institutions.

I also think we have been fortunate. The supply of molybdenum has been a little better than we had predicted right at the beginning of the shutdown. Lantheus is the Canadian producer. I will remind you that they supply many sites, particularly in Ontario. They have been at about 50% throughout this crisis. Covidien, the other supplier that relies on non-NRU sources of molybdenum, has obviously been able to supply close to 100% of their customers and has been able to share with Lantheus.

I've provided you with some charts on supply. I'll not go into these in detail, but I would be happy to answer questions. This chart provides an overview of national supply from the beginning of the crisis. This is a composite of Lantheus and Covidien supply. Because Lantheus is the primary Canadian supplier, this reflects the real status across the country, although, for example, if we look at the last week on this chart, we have something between 50% and 60% supply. These figures are very dependent upon the sharing arrangements the companies have had.

The second charts that I have provided to you are from Ontario individual institution supplies. They provide the calibration dates. The bold column provides the original generator activity that they got before the NRU shutdown, the amount ordered, the amount delivered, and then the percentage pre-NRU shutdown, and the amount that was delivered as a percentage of that was requested.

I think these data are important. It's a snapshot of one week of supply to individual institutions, and behind that is the second week.

I will reiterate. I think the situation we currently have is one of stressed stability.

There are a number of concerns. The first is reduction in the number of referrals. Last week I made cross-country phone calls to a number of centres looking at their experience in referrals. The message I got is that there has been no year-on-year change in most of the centres. I think the issues in the small urban centres in Ontario, as Dr. O'Brien has mentioned, are a real concern.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. McEwan. I'm sorry, your time is just over right now. We've gone a little over, but this does give us time for questions and answers.

[Carolyn Bennett, Liberal, St. Paul's, ON]

As he's the adviser to the government, I think you would find consensus to let him finish.

[The Chair, Conservative, Joy Smith]

Would everyone agree?