Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 26 - Evidence - November 21, 2012
OTTAWA, Wednesday, November 21, 2012
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:15 p.m. to study prescription pharmaceuticals in Canada. TOPIC: Post Approval Monitoring
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
My name is Kelvin Ogilvie. I am chair of the committee and a senator from Nova Scotia. I will ask my colleagues to introduce themselves, starting on my left.
Senator Eggleton: Art Eggleton. I am deputy chair of the committee and I am from Toronto.
Senator Cordy: Jane Cordy. I am from Nova Scotia.
Senator Enverga: Senator Tobias Enverga, from Ontario.
Senator Demers: I apologize. What am I supposed to do?
The Chair: Identify yourself, sir. You are so famous, everyone knows you anyway.
Senator Demers: Senator Jacques Demers, Quebec.
Senator Eaton: I am very unfamous. Nicky Eaton, from Ontario.
[Translation]
Senator Verner: Hello, I am Josée Verner, from Quebec.
[English]
Senator Seth: Asha Seth, from Toronto, Ontario.
Senator Martin: Yonah Martin, from British Columbia.
The Chair: Thank you, colleagues.
We continue our study of prescription pharmaceuticals in Canada. This phase of the study is dealing with post- approval monitoring. We have two witnesses with us today, and I will introduce them as I ask them to speak. I determined in advance that, since they were not here to arm wrestle, I will go with the order they appear on the agenda.
I am pleased to start with Dr. Bruce Carleton, Professor and Co-Chair of the Division of Translational Therapeutics in the Department of Pediatrics at the University of British Columbia. Professor Carleton, please.
Bruce Carleton, Professor and Co-Chair, Division of Translational Therapeutics, Department of Pediatrics, University of British Columbia, as an individual: Thank you, senators, for the invitation. I look forward to the next couple of hours with you. Please ask me all the questions that you can imagine.
I have been working in this particular area of post-market surveillance of pharmaceuticals, particularly on the safety, as well as understanding the effectiveness of drugs, for more than 20 years. I have three main concepts that I would like to present, and that would allow you to ask questions in those areas or others.
The first is that adverse drug reactions — or side effects, as they are often mislabelled in my view — are a major public health problem. In 1998, a study published by Jason Lazarou in the Journal of the American Medical Association suggested they were the fifth leading cause of death in the United States. There is no reason to suspect that our numbers, proportionally, would be any different in Canada.
Largely, drugs are unsafe because they are therapeutic products that are being used to treat significant health problems. Just like cars, they are a necessary item to be used in Canadian health care. Cars are also necessary but can be quite dangerous.
I do not suggest that the pharmaceuticals that are approved in Canada are any more unsafe because of our approval process, but I would say that our experience with pharmaceuticals, once they are approved and used, is very different from the use that occurs in the clinical trials that lead up to a licence being provided.
The best way to think about this is that in clinical trials we are looking at efficacy of drugs, not effectiveness. The difference is, of course, that efficacy is the biologic effect of the drug in a very defined population. You want to understand if the product has therapeutic value in a very defined population.
For example, if we are going to study a drug in the treatment of diabetes, we would choose a representative sample of diabetics. We would not choose very young patients and very old patients because they may be exquisitely sensitive to the product. We are just looking to understand its biologic effect.
We would also then follow patients to understand the safety outcomes that they have. It is well known in clinical trials that the safety is not particularly well characterized. Part of it is this homogenous population of patients that are defined very particularly to ensure that we understand efficacy.
In the real world of medicine, we treat patients that are a rainbow of ancestries, of experiences, of other co-morbid conditions beyond the one that the drug is being used for. All of these contribute to variability in drug response, and that variability can have serious consequences in patients and consequently why safety problems arise often well after a drug is approved for licensure.
The second point I want to make is that there are new science-based opportunities to improve the safety of drugs in individual patients through the use of what is being called personalized medicine. My colleagues in pediatrics and adult medicine who have been practising for decades would take some issue with that terminology and suggest that they have been practicing personalized medicine. After all, you go see an individual physician, not a group of physicians, to be treated, examined and a therapeutic plan established.
The nature of personalized medicine in the method I am talking about is to understand the genetics of drug response. Every step in a drug's biotransformation in the body is controlled by genes. If we understand the relative contribution of those genes towards an effect in an individual patient, we can then understand and predict what the response would be.
In 2006, my team of researchers published a study in The roman; Lancet, a journal in the United Kingdom, which showed a woman from Ontario who was taking a prescribed narcotic after childbirth for pain related to her delivery actually breastfed her child to death as a result of a duplication of a gene that converted the narcotic into a more active form. This type of information known in advance would help to improve the safety of the drug.
The third comment I want to make — taking the fact that we have adverse drug reactions as a major public health problem and we have science that can allow us to understand how to improve safety for individual patients — is to actually build a network across this country to understand these effects and how to deal with them at an individual patient level, and we have done that. Starting in 2005, with federal funding from Genome Canada and later with the Canadian Institutes of Health Research and the Canada Foundation for Innovation, all peer-reviewed federal funding sources, we created the Canadian Pharmacogenomic Network for Drug Safety. We linked all pediatric hospitals across the country. We have more than 50,000 child cases with adverse drug reactions and child cases who took the same medications without adverse effects, to understand the contribution of genetics to these problems. We are well on the road of more than just the codeine-related narcotic problem that I discussed earlier; we have several other discoveries.
I think this is an important method, where we are basically taking clinicians across the country and holding them accountable for the drugs they use on patients. We often talk about drugs as a source of harm. We talk about regulations that need to change the way we think about drugs. We talk about the manufacturers needing to accept responsibility that their products can be dangerous. I agree with all of those points, but I would say that the missing group in all of this is people like me who use the products on individual patients and monitor primarily for effect and expect patients to tell us if they have been harmed. That is the mistake. We actually have to go out and work with patients and understand both effect and harm so we can understand when this happens and what the reason is, and use this new science, pharmacogenomics, to personalize therapy in the future so these cases of unfortunate harm do not occur again.
The Chair: Thank you very much.
I will now turn to Robyn Tamblyn, who is Scientific Director in the Department of Medicine, Department of Epidemiology, Biostatistics and Occupational Health, at McGill University. Dr. Tamblyn, please.
Robyn Tamblyn, Scientific Director, Department of Medicine, Department of Epidemiology, Biostatistics and Occupational Health, McGill University, as an individual: Thank you very much for giving me the opportunity to present to you some ideas. First, I am very grateful that the Senate is preoccupying itself with this particular issue, because I think it is very important. I also think that Canada has an opportunity here to provide continued, if not more expanded, international leadership in this area.
I want to start with a few issues that I think we need to focus on when we look at what we need to do with respect to drugs once they exit from essentially the regulatory process, where they are approved or given a notice of compliance and actually enter the market and now are being used by Canadians and by people worldwide. I would have to say there are really four concerns that people have about them.
The first is what Dr. Carleton talked about, which is that in a limited series of trials you are not able to identify rare events and you are not able to identify things that might happen in populations in which those drugs were never tested. That is typically children. Particularly this network that Dr. Carleton has talked about would allow those kinds of problems to be identified in older people who have multiple problems and who, by definition, are often excluded from the trials in which the drugs are tested, even though they are often the people who are using the medications themselves.
There is this issue of adverse drug events that will occur that are rare. Sometimes they are very common, like what you see in the COX-2 inhibitors. They were cardiovascular events, where in fact you were at increased risk by using those COX-2s, which were wonderful in terms of pain, but they did have this increased risk, which you saw once you started comparing what people who were taking those drugs were experiencing relative to people who were not taking those drugs.
That is another thing: It is a common event, but it occurs commonly for other reasons as well. Those are the two things with respect to adverse drug events.
We do not really have globally — we are not just talking Canada — a rigorous approach to actually monitoring drugs once they are out in the marketplace. We have what we call voluntary adverse event reports that people have been doing. It is well recognized, just like reportable diseases, like smallpox, for example, that in fact these are not well adhered to by busy professionals. About 98 per cent of adverse events are not reported through these voluntary processes. Therefore, alternate methods are needed in order to address that particular issue.
The United Kingdom, for example, has looked at prescription event monitoring. They will pay general practitioners to prescribe these drugs. They want to monitor them in a rigorous and systemic way so they know the answer to that question. That is very burdensome for physicians, and so that has not caught on as a method of addressing this.
Canada has actually provided enormous leadership in this area through something I think the committee heard about earlier, Senator Ogilvie, which was the Drug Safety and Effectiveness Network, led by Dr. Bob Peterson. It is funded by Health Canada and involves every single province in a network to actually use the administrative data available in Canada to systematically look at what is happening in populations and being able to detect adverse events in a rigorous way.
Canadian researchers are among the world leaders in applying rigorous new approaches for unbiased assessment of adverse drug events once they are in practice. I would say that the Drug Safety and Effectiveness Network is a success story for Canada. That is the adverse event issue.
The second issue that happens when a drug comes to market is that it is approved and tested for specific problems; let us say depression. An antidepressant would then get out and be prescribed for anything. We do not actually know what they are prescribed for. That is part of the problem. There is not a systematic way of monitoring what drugs are prescribed for.
In terms of innovations that have occurred in Canada, prototypes have been built that capture at the point of care the reasons why the drug was prescribed in a systematic fashion. We have shared some of the early research that has come out of that. About 11 per cent of drugs are prescribed for indications for which they were never tested and for which there was no scientific evidence of their benefit.
Those drugs when prescribed off-label for indications in which they are never tested are more likely to lead to adverse events. It is being identified as a global problem that needs to be addressed, and there are some straightforward solutions we can adopt as a country tomorrow — or practically tomorrow — to address that particular issue. I just wanted to highlight that in relation to adverse events.
There are two other issues I will highlight and maybe I will stop at that point. The second has to do with really not the safety of drugs but the effectiveness. When a new drug comes to the market, a variety of other drugs often come in after that. They may say that these drugs have a better side effect profile or they target the so-called me-too medications. Provinces are asked essentially to make decisions about whether they will insure those drugs. They really do not have, unfortunately — not through the DSEN, the Drug Safety and Effectiveness Network — comparative information on how well they work. They need to make these decisions and they do not have a rigorous way of making those decisions. This is a tough call.
We have something called the Common Drug Review. We try to make decisions on this based on the trial information, but we do need a post-market approach that will allow us to rigorously monitor the use of those drugs, assess their effectiveness and provide that feedback to the provinces. They need to know that in order to run their health care systems in a sustainable way. Drugs are a huge chunk. It increases at about 15 per cent per year in terms of the price tag. There are various things provinces have tried to do to try to contain that. This is the kind of information they need to make wise decisions.
Even better yet, it could be that drugs are effective in some subgroups and not others. This is a whole thing about personalized medicine, so that we can actually target drugs that will work to people where they will benefit. For example, about half of antidepressants are stopped because of side effects. That is a bit of a waste. If we can target them a little better, so much the better.
The third area with a complete failure — and every country is a failure as well — is the area of getting the information back out to the providers, whether it is the consumers of health care, the patients themselves, or to the people prescribing and dispensing. There is a pathetic lack of ability to get information back out to the point of care to say this drug has a problem or here is the comparative effectiveness of that drug and here are the known risks. Therefore, we continue to see drugs prescribed when there are ``black box'' warnings on drugs to say they is unsafe, that they cause mortality in older people when prescribed this anti-psychotic, et cetera.
That is an issue we have the potential to think about solutions for in a creative way in the country. I think that is a marching order that we need to move forward. It is not by publishing more paper. It is at the point of care, where the drugs are being prescribed and dispensed. That is where the alert needs to happen; namely, at a point in time when people can reverse their decisions.
It needs to get out to consumers, as well. I think we need to look at the digital age and say we can do this better, smarter. It is starting to happen in other countries and we can do it here, too.
Thank you for listening to a bit of a rant; it was very therapeutic.
The Chair: I will open up the questions to colleagues. I want to remind colleagues that looking at the issue of off- label use will be a separate study. However, our witnesses can use examples there with regard to post-approval monitoring. We are focusing on the monitoring part today. In addition, we are looking at it from the monitoring point of view to determine how effective we are in picking up adverse reactions. Adverse reactions will be a full, separate study by this group.
The issue in asking these questions is to get these experts to comment on the business of the monitoring part, which of course leads to information with regard to these other issues. It is the monitoring we are trying to focus on here today.
Senator Eggleton: Thank you for sharing your knowledge and expertise about these issues. We are on the political end of things, and at the end of the day we will want to look at some of the concerns you have raised and determine what kinds of mechanisms would fix these problems. Please focus on that kind of answer.
Let me zero in on a couple of things. Regarding the ADRs, adverse reaction reports, we have heard some criticism in terms of how Health Canada gathers them or how Health Canada provides feedback or does not provide feedback on it. We have heard suggestions that we need to be more proactive in getting ADRs. I think the following was actually the chair's comparison: If you buy a car, they will send you an email in a few days and ask, ``How is it going? Is the service good?'' There was a suggestion that we could be doing that with respect to these prescription drugs.
Professor Tamblyn, you already mentioned the black box idea. That is an idea that comes from the United States, as I understand it. You also mentioned the Drug Safety and Effectiveness Network, DSEN, and how it is something we can be proud of; it is rather good that we have done this in this area. Some think it is not as open and transparent as it should be and that it does not have a regulatory authority. Perhaps already there are ways we can improve upon that.
Let me ask both the specific questions as relevant to ADR that I have posed, as well as DSEN, but also anything else you have said as to how those problems might translate into fixing this at a federal political level.
The Chair: Please examine this from the point of view of monitoring and getting the answers he is asking about.
Ms. Tamblyn: The situation in most countries is that if a person suspects there is an adverse drug event, they can fill in a form and send it to a regulatory agency to take note of that. As I mentioned, 98 per cent of all adverse events are not reported. We simply need a different mechanism to this kind of approach. The first volley over the court was to say, ``Let us make it mandatory.'' Leprosy is a mandatorily-reported disease and that does not help matters too much either, so I think that is not the route to take.
Looking at creative approaches, I mentioned the prescription event monitoring the U.K. has used, but it is fairly expensive and there is a fair bit of overhead attached to it. A more creative approach I had thought was published by Harvard Partners Group. They took their longitudinal medical record and when a drug was discontinued, they had to indicate why a drug was discontinued. Was it because it was ineffective? Was it due to an adverse drug reaction?
That was information collected at the point of care. It was microseconds to get the information. That information was then used to extract information from the electronic health record, packaged up in an email and sent to the FDA. That kind of systematic way of collecting data is happening at the point of care. A drug is being stopped because it is not working — that is fabulous information about its effectiveness — or because there is an adverse drug reaction.
That kind of approach is doable not just in our lifetime; I think it is doable within the next five years. We are slow in electronic health records in Canada, but I think there has been a pick-up in steam on that and now it is a matter of saying that, for a software product to be accredited, this has to be a requirement.
When a drug is discontinued, we must be able to capture why it is being discontinued. This is quite doable. This is a worldwide phenomenon that could be adopted. Canada could be the leader in this area and that is one simple approach that could be used to try to get at a more systematic collection of information without harming anybody here. It is not taking anybody any more time. I propose that as the lowest hanging fruit possible.
In order to do that, it means that some place like Infoway has to change its accreditation standards. That is pretty easy. It means that this information has to be within the current regulatory framework. I do not even think there needs to be changes in regulations to make this happen.
It means that Health Canada will need to figure out how to use this information to construct comparative risk evaluations. The know-how is definitely here in Canada.
The Chair: Before we go to Professor Carleton, I want to follow up on your answer to Senator Eggleton. Who is doing the discontinuing?
Ms. Tamblyn: That is an excellent question. There are three people doing discontinuations in this day and age. One is the patient. They are making a decision they are going to abandon therapy. Very cleverly there are some interesting follow-up programs that have been triggered, whether it is through a patient health care record, personal portal, or through what we have called the interactive voice recording follow-up systems that follow up with people as soon as they have a new prescription for a drug. They call them up on one of those annoying things that calls you on the phone, but it is from the prescriber's office to ask how the patient is doing and triages them to an expert if they are having a problem. That is another way of actually collecting prospectively in a way that does not have people going to some other place to use a computer to find it out.
The second one is the prescriber is actually discontinuing the drug on the basis of the person not responding or having side effects, which are the two most common reasons for people not adhering, or it costs too much.
The third is the pharmacist, and increasingly the pharmacists are making treatment decisions and they are being paid to make treatment decisions because they are more accessible in our country than are physicians, and they are making switches in therapy.
There are the three players, who I think would be more than delighted to provide that information.
Mr. Carleton: Like Dr. Tamblyn, I would say approximately 95 per cent of adverse drug reactions are never reported, and there actually is primary published literature in Canada to support that. There was a study published in a journal named Drug Safety in 2004 by Nicole Mittmann and Neil Shear, who is the head of the Department of Dermatology at the University of Toronto. This is an important study because one of the reasons for non-reporting of adverse events by physicians is that we do not know definitively that the reaction that we see is actually drug related or disease related or related to something else that is happening in the patient. He took a very serious skin reaction called toxic epidermal necrolysis, or TEN, and looked at these particular cases. This is a drug-induced reaction that is nearly always fatal, and these cases would be managed in Canadian burn centres. There was an easy way to go to Canadian burn centres to look at the number of cases of TEN that they had managed and compare those reports of the events submitted to Health Canada, and only 4 per cent of those cases were reported.
I agree with Dr. Tamblyn that the current method of voluntary surveillance, asking clinicians to report reactions when they see them, is inadequate.
The response of physicians to this would be they already know it was drug related so why report it? Again, this gets to the issue of what value people see in this process of reporting. I would also say that reporting is not simple. It takes time. I have three drug label changes as a result of our work through the United States Food and Drug Administration since we first began working with them in 2009 or 2010. I have one in Canada, which is interesting.
I am trying to show you that with a network like mine that is focused on pediatric drug safety, where 80 per cent or 85 per cent of licensed pharmaceuticals in Canada have no labelled indication for children, we are using these drugs off label each and every day. This is not a minor problem in pediatrics but a major problem. We really need this reporting.
However, I have a simpler approach from Dr. Tamblyn's. I believe she is right. We need electronic records and we need better surveillance systems, but for about $1 million a year I hired clinicians, nurses, pharmacists or physicians who were interested in this process in pediatric health centres across Canada. They are employees of the network. Because they are employees, they have responsibilities and a job description. If they fail to meet that by not reporting and not providing us enough detail, then there is a quality assurance process and a review of their performance and we hire and fire like any other business. I have done many of both in order to get these reports.
I want detailed reports, a fulsome set of data, in order to get to the point where I can actually come up with solutions to drug safety problems, not just to understand what drugs are causing the problems, the first part of which is getting a label change recognizing what puts certain patients at higher risk of these reactions so they can then make better risk benefit decisions with their physician at the time of prescribing, or with their pharmacist at the time of dispensing and monitoring their medication. You really need a lot of information, so this is not simple reporting.
It does not take 10 minutes to report a reaction. On average, I would say to report a single case takes between four hours and five days, full time. However, I have basically one surveillance person at most pediatric centres across Canada, and we have more than 50,000 cases and controls in this particular work for about $1 million a year. That is a small fraction of the post-market surveillance budget for Health Canada that I am using grant funds to do, and I feel this is very successful.
The concept of mandatory reporting, of making physicians or anybody involved report is fraught with problems in terms of how you are actually going to monitor and ensure that they actually do this. In Spain, it is a criminal misdemeanour not to report an adverse reaction if you are a physician. How many convictions have they had in Spain? The answer is zero.
Mandatory reporting is problematic in terms of how it is enforced. My approach was to take interested individuals at every institution and tell them this is their job. This is not on the side of their desk job. This is another responsibility. This is their only job and they report to us.
When the data come in, we are probably akin to that irritating web form that you fill out when you want to move on to the next page and it tells you cannot because you did not fill out some stupid box. If you are like me, you wonder why you have to put in your birth date. I do not want to put in my birth date, and I am trying to push the next button and it will not let me go on.
We have a quality assurance team that looks at the data when it comes in to ensure it is complete. With those complete reports, we actually showed that there is a genetic risk of about 12-fold higher if you get the most commonly used oncology drug used in the world — Cisplatin — for permanent and irreversible hearing loss. We did that with only 160 patients and our findings were published in arguably the fourth-leading medical journal in the world. It is a small number of patients, which is what we have in Canada compared to our neighbour to the south, but it is very possible to do work that is globally relevant if we do quality reporting.
This process of hiring people that are doing this is really called active surveillance. It is the process of getting clinicians who are prescribing the drug, using them and monitoring them, involved in the system of improving safety. We train in how to recognize adverse drug reactions and how to report them. We work together as a team. Each month there is a meeting with our surveillance people where we talk about these things, so we actually have quality data.
This is one thing that I would suggest regulators need to spend more time on, not just the numbers of reports of adverse events but the quality of the reports. How many reports show up in the regulator that are of sufficient quality that can be used collectively to come up with a drug safety solution? That is where these voluntary systems fail.
Senator Eaton: I am very interested in the patient rainbow testing. We heard a very interesting doctor from Dalhousie last week talking about non-drug testing on women specifically and the effects on nursing mothers. I guess that falls into a bit of your rant.
We have not discussed, and it is a shame that we dance around the whole subject, why pharmacists, who are eminently educated, I would imagine, and understand the pharmacological makeup of each drug, would not be your front-line people. They can look at a pregnant woman. They know what the prescribed medicine is made of. Why would they not be the person that we educate patients and people to go to? Why would they not be the ones to report adverse drug reactions back to you?
Mr. Carleton: In 1997 the Office of the Inspector General of the United States did a study on post-market surveillance of the most serious adverse drug reactions in the United States and at the numbers of reports generated, first by industry, which has a mandate to provide reports, but often without the patient-specific details that make them relevant to understand the solution strategy that lies ahead with the report. The manufacturers report more adverse drug reactions than any other health professional group, by far. Pharmacists actually report more than physicians report. In fact, in that 1997 report, which led to the development of the FDA's website that now has online reporting, pharmacists reported one adverse drug reaction every 26 practice years — I did the analysis — which is abysmally low. You definitely see more than one adverse drug reaction every 26 years of practice. The only group lower was physicians, who reported once every 300-plus practice years; and I do not know any 300-year-old physicians.
The point you raise about having pharmacists report is that they actually report probably more than physicians report. The challenge is the space of the practice that each group works in. Anybody who has stood in line for a prescription knows how much time you spend with a pharmacist and how much time I am talking about needing in order to get an accurate accounting of what is occurring. Most patients are not on a single medication, so it requires sorting out what the adverse effect is due to.
Senator Eaton: I go back to the same pharmacist just as most people do because it is in their neighbourhood. Would the pharmacist not have a list of drugs in a computer to know, for example, that Jane is taking OxyContin, Demerol, et cetera. Would they not know what the patient is taking? I am not talking about the patient who shops around and tries to be illegal about their drugs. I am talking about the average person who goes to the same drug store and the same pharmacist, who knows what the person is taking.
Mr. Carleton: Actually, the data in British Columbia would not suggest that people go to the same pharmacist. They would say the same pharmacy but pharmacies, for the most part, are corporate owned and there are different pharmacists on different shifts.
Senator Eaton: Would they not have the patient on their computer?
Mr. Carleton: Consider the index case that I mentioned about the breastfed infant that is poor feeding and dies six days after childbirth. Lots of children are poor feeding six days after childbirth, so how do you ascribe that to the —
Senator Eaton: Pediatrician.
Mr. Carleton: Part of the problem is that the family physician, through no fault of his own, was relying on published information saying that codeine was compatible with breastfeeding. It was not so in this particular woman. The chance of you or me, of Northern European extraction, having a duplication in the gene that converts codeine into morphine is about 1.5 per cent. With 340,000 live births in Canada, that is still about 2,000 babies a year that could be affected. If you are North African, you have a 40 per cent chance of that. This is new science that is coming out to help us understand that there are differential risks.
Senator Eaton: Really? That narcotics are compatible with breastfeeding? Beer is not compatible with breastfeeding, let alone codeine.
Mr. Carleton: The question is whether the drug is excreted in breast milk in sufficient quantities to cause harm.
Senator Eaton: You have never breastfed. I have.
The Chair: Let us go back to the monitoring part.
Ms. Tamblyn: The reality is that for serious things, they will turn up at the emergency department doorstep for an anaphylactic reaction or something like that. All players need to be involved. We need to have a mechanism of getting it from patients directly.
Senator Eaton: That is getting digital medical records.
Ms. Tamblyn: Empowering people to say that this is the thing to do and then making it possible for them to do it easily and efficiently. Some drugs are abandoned, and no one knows about it except for the person who made the decision that it made them feel terrible and so they were not going to take it. Community-based pharmacists have not been playing the role that they could play. Their business practices are changing as the whole corporate model is changing. It is a good time to engage them more than they have been. We have never really engaged people in providing us with feedback on how well the drug is working. That is also relevant.
You will have to get the most serious ones from places like hospitals, emergency departments and children's hospitals for these very serious ones. The community pharmacist will not know about them. There are multiple layers of people with the same common goal.
Senator Martin: I am intrigued by the work you are doing, Professor Carleton, the network that you describe and the system by which you collect the data. All of it sounds like an excellent tool. How far along are you in terms of this particular initiative? I understand that there is a long-term goal to make it more user-friendly. If so, who would have access to this information? Who has access to it now and how is it used?
Mr. Carleton: That is a good question about how we are taking the knowledge we are gaining from the network and using it to create solutions to drug safety problems.
Like any network, you start with a range of ideas; and we have decided to start in an area of low-hanging fruit — extremely toxic medications that are causing problems that are likely caused by differences between us genetically — and understand the role of genetics in that. We start with potent pharmacologic agents that are used at high dose to prolong life; and that is in cancer. That is where we have begun.
Besides the work on codeine, the other issue is drugs used in pediatric oncology where 3 per cent of children treated with the most common cancer type lymphoblastic leukemia actually end up in heart failure after or during treatment, which is very high; and 17 per cent end up with reduced heart function as a result of their cancer chemotherapy. This idea that these are side effects — unfortunate consequences — on the road to remission and cure of cancer is true, but there is no reason to suspect that we should not be able to separate out the harmful effects and understand that certain patients are higher risk than others. We just finished a large study and are continuing to work on this and expand this work into adults to look at profiling both the clinical risk factors for heart failure from these drugs. We know, for instance, that the higher the cumulative dose is of this drug that you get, the more likely you are to suffer heart failure. We know that younger babies are more likely to suffer heart failure if given these higher doses.
Some groups feel that young girls are more susceptible than young boys in terms of cardiac dysfunction. We add now the genetic information about these. We began finding in children that we profile with the genetics that had heart failure that they were missing genes that actually remove the drug from the cardiac cells. Those are called e-flux transporters. The drug goes in, but it cannot get out and the cell dies. That is likely the mechanism of the heart cell dying and causing the heart problems.
Therefore, we have created risk prediction models. In academic medicine, you do a trial, have it peer reviewed and published, and then you move forward. We have published this work. The next question is how to disseminate that information to clinicians and families. The next step is to develop clinical practice guidelines on how this genetic information should be used. We need to gain more information at the same time. We put an international panel of experts together to put these guidelines together. We have written them.
I went to spend some time at the Food and Drug Administration. I said, ``You give guidance documents to industry that are revered as well as reviled. I want my guidelines used, not just ending up in some academic journal that no one reads or uses. How do I create documents that are revered?'' I learned a lot about the way that needs to move forward.
One of the next questions is to take these very comprehensive documents and make them into smartphone and smart tablet applications that can be used at the bedside to help understand the individual risk. The great news about this particular study is that 46 per cent of the children we have studied have virtually no risk of cardiac toxicity from these particular agents. That is exciting because that means that children diagnosed with leukemia at a late stage might benefit from even higher doses without toxicity. That needs to be studied, but that is one of the benefits of the current work.
The next thing we found is that 17 per cent of children are at very high risk; 33 per cent of those patients actually have serious cardiac dysfunction in the first year of chemotherapy and 24 per cent of that group go into heart failure. This allows us to understand which group a child is in before we begin therapy. That is how we are working with this. The first question is disseminating the guidelines.
The other issue I have learned by working with the FDA is how important patients and families are at wanting to understand risk and benefit. We used to talk about risk-benefit ratios but that requires a denominator we do not have. Now we talk about risk-benefit profile. We know the benefits of these drugs. They have taken us in childhood cancer survival from 30 per cent in the 1960s to more than 80 per cent today. That is the great news. However, we still have the toxicity problem. Now we can profile the individual child's risk and provide that both to clinicians and to families.
This is actually being done in British Columbia. We have financial support from the provincial health services authority to actually roll this out in British Columbia. We are doing that this year by doing genetic testing on both children and adults to learn how this profiling can best be used in cancer care.
Senator Martin: You gave me a lot of information. Thank you. However, my question was going back to what Dr. Tamblyn was talking about. You have gathered valuable information that should be, as you say, clearly disseminated to the care providers and even to families to understand and to be informed in the choices they make. It is good to know that in B.C. this is being rolled out. There needs to be that middle piece. You are in a very specialized area, but that information needs to get to all of the people that will be impacted, as well as rolling out this very valuable information to better provide for patients and whatnot. It is always those sorts of missing pieces or the gaps.
I think what you are doing is very good. I hope that continues. Maybe it is a model that can be used for other specific areas, whether it is pregnant women and the lack of information we have on drugs for use on pregnant women. Congratulations on what you are doing.
Mr. Carleton: To follow up, I think it is important to understand that too quick a dissemination of information that is not wrong is also a concern. We are talking about tremendous survival advantages. It is about convincing the clinical community that there is a new way to prescribe these and think about these — that survival is not the only outcome to think about and that it is also the adverse effects. Is a big challenge and it requires a lot of supporting evidence to be able to do that.
I do not want to throw the baby out with the bathwater by getting people excited for something that turns out not to be relevant in certain populations. However, I agree with you.
Senator Martin: Thank you.
Senator Seth: Senator Martin asked the question I wanted to ask. You have answered most of it. Are you using the same method in pregnant women? Have you started finding out your genetic method to avoid adverse reactions in pregnant women?
Mr. Carleton: This links into DSEN because we are a funded team through DSEN to look at a variety of issues. One particular drug safety issue I am interested in is in women who are pregnant and have asthma and are using inhaled cortical steroids — the anti-inflammatories that are inhaled into the lungs to prevent exacerbations. The impact that has on fetal development is one particular question we are currently asking.
Are these drugs absorbed? They are taken into the lungs and they are thought to be locally distributed. Do they end up in the bloodstream? Do they affect fetal development? This is something we are actually working on. We will have other studies as time moves on.
The Chair: Dr. Tamblyn, do you have any observations on these last two questions? You are not required to add to them, but I wanted to ensure you were not being passed over.
Ms. Tamblyn: The one thing I think we should keep a perspective about is that about $40 billion per year in Canada is spent on prescription drugs. About a third of those drugs are either stopped because they are not effective or because they produce intolerable side effects. We need solutions for specialized populations where there are very expensive drugs — such as HIV, cancer and some of the biologics used for the immune diseases.
However, we need something that will allow us to look at it across the board in something like pregnant women where we actually have in Canada very rich longitudinal, integrative data sources, enriched day-to-day with clinical information that is digitized. We have the know-how of how to use that.
I want to ensure we do not design a system that is highly specialized where we need it in these specific areas with very potent medications. I do not want to lose sight of the fact that the biggest drug groups causing the most harm in terms of the population are the psychotropic drugs — the antidepressants, the antipsychotics and the antihypertensives. These are used every year by about 15 million Canadians. I just want to ensure we do not lose sight of that.
Senator Demers: I want to make a statement and ask a question. Chair, if I am out of line, I want you to stop me.
The Chair: I have the whistle ready.
Senator Demers: I wanted to say that your confidence today has brought me to a level where I can speak about that. You have been absolutely unbelievable. The only person I spoke to recently was Dr. Seth.
I suffer from a high level of anxiety. I was given different medication, such as Paxil, Prozac and Abilify. Some have led me to gain weight by the week or by the month. Some have mood swings. I am usually a person who when I get up in the morning I am happy.
I had to miss the Senate for three months last year towards the summer because I suffered from a major depression because they had given me a pill called Abilify. I stayed away from the Senate because when I am working here, I want to function well. I have a wonderful doctor now who has given me Zoloft. I feel very good and Dr. Seth said it is working very well.
From what I hear recently, doctors — not all — just give out any pill that has no follow-through and a lot of people commit suicide — not that I have ever thought about it, by the way. Why is it that doctors who are so highly qualified to give such medication just give them out and there is no follow-up? You did talk about follow-through. That is what I want to speak about.
The Chair: I will limit the witnesses to dealing with the issue of post-approval surveillance. This is not about the individual case or any of that. If there is any aspect of post-market surveillance that emerges from the statement that was made, please make an observation, but not beyond that.
Ms. Tamblyn: I hear you. This is exactly what the drug benefit managers want and it is exactly what the physicians want: They want to know how well these drugs are working when they actually try them out on the people for whom they were not tested, or not in sufficient numbers, to actually know whether that drug will work well for you.
Let us say the United States is putting a huge amount of money into doing comparative effectiveness research. Once a drug has been released into the market, that will allow for it to be compared to others not done in the pre-regulatory phase. It is not tested against other drugs for treatment indications, such as anxiety, for which that drug was probably never tested for. There is a desire to use drugs for other things. There is a bit of experimentation happening on the ground, and there is no rigorous way of following what we put in place in order to provide the additional knowledge we need to have to see how well the drug is working once it is in practice.
When you look at solutions with adverse drug reactions, you need to do a risk-benefit analysis. Are you willing to tolerate some side effects? The drug needs to work very well. The two of them have to be looked at together. We cannot isolate one and throw some drugs out that are beneficial because in a small subpopulation they produce horrible side effects. We need a systematic investigation of both parts of it — the effectiveness of a drug and its risk — in an ongoing way once a drug emerges and has been approved for marketing.
Mr. Carleton: The specific question is why prescribers provide these things and do not provide adequate monitoring. To get back to what Senator Eaton was saying about pharmacists providing monitoring services, in an ideal world you would have a prescriber who would also monitor and have a double-check system with a pharmacist that dispenses and monitors at the same time. I have tried to work on those systems. Frankly, I find my system is better, which is to get highly trained individuals who focus on these kinds of issues.
I agree that is what the system ultimately ought to do. Prescribers ought to be asking not just about how you are feeling in terms of effectiveness of a prescribed therapy, but also about harm. When they dispense, pharmacists should not just be asking ``How are you feeling?'' but ``Are you experiencing any of the following adverse events that have been associated with the use of these drugs?'' That information could be fed back to the prescriber about whether therapy should continue.
Senator Cordy: You have both made a difficult subject very clear to us for those of us that do not have medical backgrounds. Thank you for that.
You have spoken about your active surveillance and the clinicians you have hired. It sounds like you are getting good results. This is a model you are using in children's hospitals. Is it a model we could use in other hospitals or even just for people who are not hospitalized? How difficult would it be to use that model and vary it somewhat depending on the circumstances? With 98 per cent not disclosing adverse drug reactions, something must be working better than what we are doing. How easily transferable would this model be?
Mr. Carleton: The model is directly transferable. We have 10 adult hospitals in Canada that are now participating. We are involved in multiple countries such as Brazil, Mexico, the United States, New Zealand and Australia. There are sites all over the world that I am working with, including Germany, the Netherlands, Denmark and so forth. People are very interested in this.
In terms of the outpatient environment, I think it is important because we think of a hospital as in-patient. The reality is that the vast majority of patients I see in hospital are in the clinic attached to the hospital. The average Canadian is never hospitalized. Most patients are hospitalized, if they are, for about two and a half days. The rest of the 360-plus days they are being seen in clinic environments. We have these huge towers at our academic health centres where those patients are seen. Most of my reports come from the clinics, not from the in-patient wards. This is an ambulatory care model of a network and it functions in that way. It could easily be applicable.
To Senator Eaton's comments, I have tried to get pharmacists in community pharmacies. The problem is that 80 per cent are corporate owned and the pharmacists have a job to do for the corporation, which is to dispense medication and there are large volumes of those. If you are talking about asking extensive questions and follow-up, you are delaying the whole process that is going on. You have to fight that particular system.
The other point is that in British Columbia, the reimbursement for dispensing —even for professional services that pharmacists provide — is to the pharmacy, not to the pharmacist. Another barrier we have to overcome is that they, themselves, are not being compensated for that particular work. I think compensation is a way to hold people accountable to the work they do.
Ms. Tamblyn: If I could make a comment, I think a model such as proactive surveillance as Dr. Carleton outlines is good for the serious adverse events that lead people to be hospitalized. I think there is a mechanism there. Five per cent of people are hospitalized in any given year and 80 per cent of people get a prescription drug every year. You need to have a denominator. You need to know how many people got that drug to start with and then look at the numerator. How many people had an adverse event? If you only look at the numerator, you would say psychotropic drugs and antihypertensives cause most of the adverse events, but it is because those are the most common drugs prescribed. You need to have both.
I cannot agree with Dr. Carleton that this is a way to monitor the 20 million Canadians using drugs every year. I do not think it is sustainable in that way. For serious adverse events, this is the way to go. For adverse events that compromise the utility and effectiveness of those medications, I do not think it is the way to go. You must integrate it into the work processes, use information technologies to get it done and use all the mobile things. Everyone in Canada has a cellphone; we should be using that for goodness sake.
The Chair: We will not get into a debate if you have a specific point to make.
Mr. Carleton: The specific point is I am not suggesting this is the only system to use. I am suggesting it is one of many systems. Some systems are easier to implement than others and to get benefit from. I have a system that is designed to look specifically at adverse drug reactions that are causing permanent disability, death and serious outcomes. I agree with Dr. Tamblyn that multiple systems are needed. I am not suggesting that anything is wrong with the other systems. I am suggesting we need more.
Senator Cordy: To have variety and get more than 50 per cent of people for reporting.
Mr. Carleton: Yes.
Senator Cordy: Most Canadians who get prescriptions from a doctor — you said 80 per cent of people will get a prescription during the year — assume when they get it they will feel better. If they do not feel better right away, family and friends say just keep taking it; it takes three or four days before it is going to work and then you will feel better. If they are not feeling better, many people will stop taking it, throw the pills in the drawer and not even bother telling the doctor they have stopped.
I am not sure we do enough risk-benefit analysis with a patient before they get the prescription. When I get a prescription, I am not usually told that these are the adverse effects you will have. Are patients informed if they are given a drug that is being used off-label? We have heard from others that perhaps we should have an indicator on the label that this is a fairly new drug that has just finished clinical trials. Patients may put up the red flag and say, ``I should monitor this and if I have an adverse reaction, I should report it to my doctor and not just stop taking it.''
Are we doing enough risk-benefit discussion at the point of the patient either getting the prescription filled from the pharmacist or from the doctor prescribing the medication? Do patients have enough information?
Ms. Tamblyn: The answer is no. Increasingly, the provinces are funding pharmacists in community environments to increase the amount of clinical services that they are providing, including providing people with a better understanding of the drugs they are taking, doing medication reviews. Much more can be done in that respect. I think it is a target that we should be aiming for.
Mr. Carleton: I agree with Dr. Tamblyn that we are not giving enough information. I would also say that the prescriber and the dispenser should be doing a systematic head-to-toe assessment, not just asking patients if they are having any problems or about specific reactions but asking ``How do you feel?'' Let us start at the top and work down. I do a systems analysis: Are you having any particular problem with your skin; are you having any particular problem with your eyes, nose or mouth? We go through a variety of questions to understand the effects.
There is this obsequious bias in medicine, which is the desire to please patients. The prescriber has given you a therapy. For you to come back and say it is not helpful is difficult for many patients. This could be more of a generational issue for older Canadians to suggest that. Therefore I want to understand this. I want them to understand that the effects they are attributing to a flu-like illness might in fact be drug related. Those discussions take time and energy.
I agree with Dr. Tamblyn. Pharmacists can help with this as well as the ones who are providing the drugs.
The Chair: The reality is we live in a real world and there is a limited amount of time for everyone involved in the system. The two of you have given us a very good overview of what is possible, Dr. Carleton, in terms of taking a focused approach and being able to put resources in to go into considerable detail in looking at a focused area with regard to monitoring the behaviour of patients on given drugs. You have given excellent examples of what that can lead to in terms of overall conclusions.
Dr. Tamblyn has put it in the perspective, however, of the sum total drugs, over 4,000 or 5,000 available to Canadians on a regular basis, and some of those being used over very large percentages of the population on an ongoing basis for which that kind of detail is perhaps not immediately available. However, out of the kinds of situations you are describing perhaps there will be lessons that will allow us to formulate a broader approach.
I want to put before you an example we heard at this committee. It is a pilot study being carried out in the eastern U.S. I address this to Professor Tamblyn. It relates to the point that you were making with regard to when drugs are stopped by the individual, by the prescriber or by the pharmacist and immediate follow-up. However, in this particular case the pilot project is — and in the United States they are getting the consent of the patient who has been given a prescription — following up with those patients a month after the prescription is filled.
This comes back to what Senator Eggleton was alluding to. I was using the example that it seemed to me this is the kind of thing that we as consumers are increasingly used to. We take our car in for service and we get an email within a week from the manufacturer asking for our experience there. This particular situation is following up deliberately with patients who have agreed to be followed up on and they are being followed up in one month.
It seems to me that this has the elements of a technology-based follow-up that will not immediately give the detail that Professor Carleton is talking about in terms of the complexity. I want to come back to that thought. I do not want to interrupt my train here, but I want to come back to that complexity. This might be a reasonable way to get that first cut of information that would allow us to drill down further.
Professor Tamblyn, would you comment on that?
Ms. Tamblyn: I would love to. I can even guess what that particular pilot project would be and, in fact, some of the collaborators on that collaborated with our team. We organized a similar set-up in Montreal and Quebec City.
The way it worked was as follows: Physicians were prescribing electronically. Whenever there was a new drug being prescribed, they had information on all dispensed medications and a complete historical profile. They would have an alert saying that this is the drug follow-up program; do you want to enroll this person in the drug follow-up program? By enrolling them, they simply had to put in their phone number. Their phone number was sent to an automated telephone service, which is an interactive voice recording system. It actually called the person at home at periodic times saying that this is the doctor's office following up.
It is really interesting because it has been used in antihypertensive clinics and in anticoagulant clinics where it is very common that people have bleeds and side effects from their anticoagulants. In this case it was used in a primary care practice environment. That person was called up. We found that 50 per cent of people indicated they had some problem or wanted to speak to the pharmacist. The call-up was at 3 and 21 days. There were two call-ups. Of those 50 per cent of people, 25 per cent had some sort of adverse drug event. These were not the anaphylactic responses, but they were sufficient that they did not want to continue taking the medication. This is a huge issue when it comes to controlling hypertension, congestive heart failure, diabetes and so on, if people are actually having such intolerable side effects that they do not want to continue.
Once those people were identified, an email was sent to the pharmacist who then called up. The pharmacist happened to be in Germany for the entire summer. In fact, she did all the calls from Germany. She would open up that person's electronic health record, look at what they said on this call and then she would actually call them up and ask how things were going and what the problem was. The pharmacist would fill in a form that would be like your form, but not quite as detailed, about what the issues were and what her advice had been. It was oftentimes an issue of dose reduction because side effects are usually dose related. The dose of the medication would be reduced and an email would be sent back to the physician. It would go on the dashboard of the physician's electronic medical record that this person had had a problem, these are the actions that had been taken, and what they would recommend if they felt the drug should be switched to something else. They did not have the scope of practice to do that themselves.
These are all things that have been proven in Canada in various research environments. We can actually do this. In fact, it does not have to be this way, but there is the digital capacity to do this in a way that we could really make a lot of gains in Canada.
The Chair: It really seems to me that, as we have listened to the witnesses across this study, the first critical issue is finding a way to get that initial input on a much broader basis than we are succeeding to do now. I think what Professor Carleton has done for us today is helped elaborate the incredibly detailed analysis that must occur even before you can determine whether the effect the patient is suggesting they got is related to this particular drug or to whatever other myriad of issues the individual could have in drawing the final conclusion. However, you have to get information into the system that you can begin to drill down on.
Professor Carleton also went on to give an example of a highly specialized approach in the pediatric area with the resources put in to do that kind of thorough analysis, which is an absolutely excellent example. The two of you together have put this into context. We need to find a way to get that initial input that allows us to go further.
To take the pharmacist example, this committee did a study on Canada's response to the H1N1 pandemic. This is an example where pharmacists have an opportunity to provide information on a larger scale, as they themselves pointed out in testimony at this committee. Roughly two weeks before it became apparent in the general population that there was an emerging flu epidemic, they were aware, and that was because of the number of prescriptions of Tamiflu they were filling at a given time.
That is a simple thing. I will admit that it is not the same as an adverse reaction, but it showed the potential. If we can get the right questions into the system, they are a potential resource with regard to this issue of collecting that kind of data at the front line.
I did not specifically ask you, Dr. Carleton, but on the question that I put to Dr. Tamblyn, is there anything further you would like to suggest?
Mr. Carleton: No. This is a huge problem, as I said when I started my comments. The more people who want to work on solution strategies, the better.
Currently, we do not have an adequate system. I have no problems at all with involving pharmacists and physicians in these kinds of monitoring systems, but I must say that I am not just interested in finding out what adverse effects occur. I want to know what to do about those things. Predictive tests that can be used to define individual risk are a part of the goal of what we are working on.
The Chair: You gave an excellent example of something we tried to get at with some of our earlier witnesses regarding the use of this kind of surveillance to facilitate the personalized medicine approach. Indeed, that is exactly what you have described. You used those very words in terms of this approach, and it is a wonderful example in that area.
Senator Eggleton: This is completely different but gets back to the question of mechanics and how to fix the system we have. We have had some criticism of the industry and of Health Canada. Some of the criticisms are around openness and transparency, which have come up regularly. Some would suggest that one of the ways to fix this would be to create a drug regulatory agency that is independent of Health Canada. France has done this with a national agency of medicine and health products. It gets all of its money from public funds whereas Health Canada, particularly in the clinical trial stage, gets industry fees. It comes under the control of Parliament in France, so it is independent in that respect. Do you think that something like that would be beneficial here? Do you have other suggestions as to how we can fix the regulatory problem from our end?
The Chair: That would be as it relates to surveillance. I will restrict it to the surveillance of drugs. I understand the point, and we will get into the adverse reactions in detail and the off-label use where regulatory issues become much more direct, but perhaps you could interpret it in terms of the surveillance issue.
Mr. Carleton: The Office of Legislative and Regulatory Modernization at Health Canada has been engaged in looking at a new way of regulating prescription drugs and giving them time-limited licences on the market. For example, you might have a licence for five years to market a drug in Canada, at which time you would have to provide evidence of efficacy and safety in the Canadian population in order to be re-licensed.
Obviously, there are some concerns about such a significant change from the pharmaceutical industry, and probably from many sectors in Health Canada. This is a great idea, by the way, and I think that if done appropriately with clinicians and patients, not just industry, responsible for providing information about efficacy and safety, we could end up with much more information about how these drugs are working in their early post-market period and subsequent periods as the rainbow of patients that take these drugs becomes more diverse. This is an excellent opportunity for us to put this in. I am a little bit nervous about mandating the institutions to provide these data. Individual prescribers and dispensers should be the people that help to colour the system with information about drug experience.
Senator Eggleton: Professor Tamblyn?
Ms. Tamblyn: I am a little conscious that you want to pull apart surveillance from adverse events. Everybody really wants to know how well the drugs are working once they get into the market and used in different populations than those in which they are tested. The payers in particular need to know that information because they need to make decisions about whether they are going to pay for the drugs. I would hate to see a system that is set up only to look only at the risk or adverse events and not at the effectiveness because that would be counterproductive to the whole desire to get the bang for the buck.
This idea of having a five-year license which potentially would be tied to looking at real world effectiveness of drugs and real world risk would be a very good idea. The industry would be very interested in doing that if it provides them an earlier entry into market, which is something they will be talking about in respect to that when drugs look promising and they want to do head-on-head real world comparisons to the other drugs on the market. That could be a triple win situation for everybody involved. I do not know whether you need a separate agency for that, but you clearly need to partner with the provinces to make it happen.
The Chair: However, they could be mandated to look at both sides of that issue.
Ms. Tamblyn: Yes, they have to look at both sides.
The Chair: The EU does something along that lines of what you describe.
Ms. Tamblyn: Off-label use sometimes proves to be incredibly beneficial. With some of the drugs that were used off- label, they discovered new indications.
Mr. Carleton: The area of pediatrics is the perfect example.
Ms. Tamblyn: Yes, they are completely off-label.
Mr. Carleton: That is important. We should not treat children with cancer because we do not have the evidence, but we should collect the evidence in a systematic way so that it informs prescribing in the future.
The Chair: We will have a very interesting study when we come to those issues.
Senator Cordy: Chair, before you adjourn the meeting, I would like to raise a point of order.
The Chair: Okay.
With that, I will draw this section of the meeting to a conclusion and thank our witnesses for giving us such an interesting, detailed and professional summary of key aspects. I thank our committee for asking questions that elicited the kinds of responses we got.
The witnesses may depart, and I will ask committee members to stay in their seats.
Ms. Tamblyn: Thank you.
Mr. Carleton: Thank you.
Senator Munson: The only thing that Jacques Demers is depressed about is that the Habs have not won a Stanley Cup since 1993.
The Chair: Senator Cordy?
Senator Cordy: Thank you, chair. I thought I should speak before the gavel went down.
I just received a copy of our agenda for tomorrow, and I notice that the first part of the meeting is in camera. I assume that the decision to meet in camera was made at an in camera meeting of the steering committee.
The Chair: Yes.
Senator Cordy: I am not sure whether it was unanimous. On the same agenda for tomorrow is Bill S-204. Will Bill S- 204 be discussed at the in camera meeting?
The Chair: The procedures to be used in the meeting will be discussed in the in camera session.
Senator Cordy: Will it be discussed during the in camera meeting?
The Chair: There will be an in camera meeting at the beginning, and the issues will be discussed in camera.
Senator Cordy: The issues of Bill S-204.
The Chair: There will be an in camera session prior to the public meeting on Bill S-204, yes.
Senator Cordy: Right. Hundreds of MS patients have been following our meetings on the webcast, and they are waiting to hear the clause-by-clause consideration of Bill S-204 tomorrow. If they tune in tomorrow morning and discover that Bill S-204 has already been dealt with at an in camera meeting, it would be quite a surprise to them. It would be unfortunate if it were not open and transparent. I have no problem with discussing a draft agenda. We have in camera meetings for that all the time. However, if we are going to discuss the bill in camera, then for the MS patients who would be watching for the webcast, I would find it quite offensive.
The Chair: Senator Cordy, I can assure you that decisions of the committee in making recommendations to the Senate will be conducted in public.
Senator Cordy: I am sorry.
The Chair: I can assure you that with regard to a bill, such as Bill S-204, the final decisions of the committee will be taken in public. I assured Senator Eggleton of that when we discussed this at steering committee as well. The final decisions of the committee will be taken in public.
Senator Munson: Clause-by-clause consideration will be in public.
The Chair: That is on the agenda and will be an agenda item in public.
Senator Cordy: Thank you.
The Chair: The Rules of the Senate will apply with regard to how we handle that. It is on the agenda for an in public session. Does that answer your question?
Senator Cordy: As long as MS patients are able to watch the clause-by-clause consideration of the bill in public, then it is fine with me.
The Chair: The agenda item ``clause-by-clause consideration'' will be dealt with in public.
Senator Eggleton, I hope you can confirm that is the assurance I gave you.
Senator Eggleton: Yes, absolutely.
Senator Cordy: Thank you.
The Chair: The committee will determine all the rest. I can only tell you what the procedures will be.
Honourable senators, thank you so much.
(The committee adjourned.)