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Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 11 - Evidence

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OTTAWA, Wednesday, May 9, 2001

The Standing Senate Committee on Social Affairs, Science and Technology met this day at 3:52 p.m. to examine the state of the health care system in Canada.

Senator Michael Kirby (Chairman) in the Chair.

[English]

The Chairman: Our witness from Canada's Research-Based Pharmaceutical Companies is Murray Elston, President. Mr. Elston is also the former Minister of Health, Province of Ontario. With us from the Coalition for Biomedical and Health Research are Barry McLennan, Chairman and Charles Pitts, Executive Director. Thank you for attending.

May I suggest that you begin with a relatively brief opening statement so that we will have time for questions.

Dr. Barry McLennan, Chairman, Coalition for Biomedical and Health Research: Thank you for the opportunity to appear before the Standing Senate Committee on Social Affairs, Science and Technology, as you look at phase two of your study on Canada's health care system.

Research knows no boundaries; it is a global activity. That is my first point. In fact, in Canada and in the world, we are experiencing a profound revolution in the field of health research This revolution may soon lead to our understanding of the molecular basis of human biology and disease. Eventually, our understanding of human genes will lead to health strategies to avoid and not just to fight disease.

Many countries have determined that innovation will be the major economic driver of this century. As the Honourable Gilbert Normand, Secretary of State for Science, Research and Development, said recently,

An economy based on the creativity and innovation of all of its participants, and consequently, its partners, will benefit all Canadians at the four corners of our great nation. In future, our main objective must be to establish a genuine "culture of innovation" in our everyday life, in our general conception and in the way we do business.

In our brief, we discuss the impact of several new initiatives on health research in Canada. These include the establishment of CIHR or the Canadian Institutes of Health Research. The institute directors are now in place and the institute's advisory board has been put together. Each of the 13 institutes is in the process of developing strategic initiatives to respond to significant health research concerns in Canada.

Expectations among health researchers have been dramatically increased with respect to the opportunity to conduct innovative, excellent research in Canada. The number of research proposals submitted to CIHR has increased dramatically. In a way CIHR has become a victim of its own success. This has presented a bit of a problem. This leads me to our first recommendation on page 3 of the brief.

The Coalition for Biomedical and Health Research urges the federal government to fulfil its commitment to invest 1 per cent of the health care budget in health research for the benefit of all Canadians, by the end of their current mandate.

CIHR has a cash flow problem. Because the demand is so high, the applications for good research are high and the current budget is presenting a bit of a difficulty. If you think of the 1 per cent target and the plan was to ramp up over 4 or 5 years to 1 per cent, there is a bit of a lag right now, in year three. I urge you to do anything you can to persuade the government to follow through with the game plan.

Genetics and genomics will play a central role in health care delivery. The ability to link individual genes to specific disease has tremendous implications with respect to the prevention, diagnosis and treatment of disease. I think you would all agree that prevention and, indeed, eradication of disease is a most desirable objective.

The economic burden of illness in Canada is significant and must be reduced. Biotechnology is an enabling technology defined as "the use of living organisms or their parts to produce products or services." Modern biotechnology is based on our understanding and newly acquired capacity to manipulate life at the level of genes and proteins, and hence the new words, "genomics" and "proteonics" et cetera.

As the Finance Minister, Paul Martin stated:

New technologies create new industries. New industries mean new markets - global markets - and global markets bring new rules, and rule number one is don't be second. To the first mover go the prime opportunities - to hit the ground running, to become the standard that future rivals will have to displace.

That should be an objective for Canada.

Canadians will also benefit through the creation of knowledge-based high-paying jobs. Highly educated expatriate Canadians will find it easier to connect with exciting new research opportunities in Canada. As one of the fastest growing industries, biotechnology will attract economic interest and investment. Above all, these investments in health research enhance the health of all Canadians.

CBHR recommends the implementation of a comprehensive, national policy for the development of a vigorous biotech industry in Canada. It does not doubt that Canada can lead the world in biotechnology, while addressing the ethical and social challenges that are inherent in this new frontier.

We recommend that the Government of Canada identify priorities, confront the issues and create specific action plans to support biotechnology, and do so without delay.

Most important, Mr. Chairman, we recommend that a public awareness campaign be undertaken to explain to Canadians the benefits of biotechnology and the promise that it offers.

R&D investment by most sectors of the private industry in Canada is unacceptably low. This constitutes a most pressing issue - particularly as it concerns Canada's emerging health biotech industry. There is a chronic lack of access to capital to support the lengthy R&D process that characterizes this sector. There are few financial vehicles to bridge the gap between discovery and the marketing of products.

The result is that discoveries are orphaned and start-up groups are subjected to very demanding angel financing. This is a structural problem that public sector intervention could help to correct.

There are a few issues that I will mention quickly. One is, creating a level playing field. Academic health centres are integral to education at the undergraduate and postgraduate levels in this country. Unfortunately, many are still seriously underfunded and unable to respond to challenges of contributing to Canada's success in developing globally competitive research.

Given the positive, well-trained and challenging clinical faculties in many specialities across this country, those provinces with healthy budgets are able to offer salaries and resources that attract away from these critical faculties from underfunded centres. This internal competition for talented people is counterproductive. It is an urgent matter that requires rapid attention at the federal level and the provincial level, before several of the faculties of medicine in this country become incapable of meeting the standards set nationally and, indeed, their own accreditation standards.

I have a comment on animal welfare. CBHR is in agreement with the major thrust of Bill C-15. However, we are concerned about the potential impediments that it may have on legitimate, responsible, ethical, sound research testing and teaching. Our recommendation, on page 9 of the brief, asks the federal government to endorse the Canadian Council on Animal Care, CCAC, standards for the care and use of animals in research, and to ensure those standards are the basis for any legislative measures aimed at protecting animal welfare.

CBHR supports the basic purpose of the Personal Information Protection of Electronic Documents Act, PIPEDA. However, as written, the act is of serious concern to the biomedical health research community. We believe its application could blot out the very measures the government has undertaken recently to encourage health research in this country.

Our recommendation is that a task force be established to examine the impact of PIPEDA on health research, and that health research activities be specifically exempted from the legislation, as they are at the moment. We recommend that the exemption continue until such time as the task force has completed their work, and any necessary remedial actions are undertaken to ensure that health research activities are not undermined by the legislation.

In conclusion, I would like to make three points.

CBHR urges the federal government to fulfil its commitment to invest 1 per cent of the health care budget in health research for the benefit of all Canadians.

CBHR recommends that a public awareness campaign be undertaken to explain the benefits of biotechnology to Canadians.

CBHR calls on the Government of Canada to identify the priorities, confront the issues and create specific action plans to support biotechnology and to do so without delay.

The climate for health research in Canada is improving. Much has been done through the establishment of CIHR, the CFI, Genome Canada and the Canada Research Chairs Program. Much more remains to be done so that Canada can take a world leadership role in health research. Thank you.

Mr. Murray Elston, President, Canada's Research-Based Pharmaceutical Companies: Thank you. I represent Canada's innovative pharmaceutical sector. The material that you have is divided basically into two parts. The first, looking at some of the issues in which we think genetic research will assist us to move forward. In the second, I have identified five different areas where we believe there are implications for public policy. I will highlight those, rather than read through them.

For those of us who were involved in health and public policy in health care in the mid-1980s, a wonderful transformation has occurred in terms of knowledge and the ability to deal with diseases. In the days when I was health minister in Ontario, we only dreamed that we could take some positive action towards solving some of those diseases.

Having said that, research has spun out in three segments. One is based on chemistry, the second is based on biology and the third is based on genetics. Dr. McLennan has identified some advantages of that.

Let me go over four items that I think are interesting from the genetic research area. One is that genetics give us an accurate understanding of the underlying causes of disease.

Second, genetics help us to find new targets for treating disease or, in fact, avoiding it - defeating it is probably the best way that I could put it.

Third, the benefit of genetics is that it helps us to develop new medicines more efficiently and effectively. That is a big thing for our industry. At the moment, it is a long process indeed from the point where we first discover a candidate molecule to the time when we ultimately are able to prove that it will have some effectiveness and safety in its administration to the general public. Out of every 10,000 molecules that are discovered, we are fortunate if we find one that ultimately proves successful in treatment of a disease category.

From an investment of about $700 million, it is through that type of process that we hope to be much more efficient and to have a much shorter time frame in discovering effective new medications.

The most resource-intensive time of this development phase, of course, is in the clinical trial area. We see thousands of people put on clinical trials to prove safety and efficacy. Perhaps now, instead of choosing a broad population band to act as participants in the clinical trials, the genetic research that we are undertaking will be able to target specific groups of people to test a much more specifically developed medication. That will make it much easier to identify the positive molecules than it now is.

Fourth, genetics will help us to identify the right drug for the right patient. Right now, as you probably know, the leading therapies for any medical condition work in 75 per cent to 80 per cent of the population. For between 5 per cent and 10 per cent there may be, and there often are, side effects, which cause some difficulty.

You can see that with the implementation of genetic research and the importance of this as an additional element in the research world, genetics will transform the way in which we deal with medical research. We will create new and powerful ways that will have great benefits for the public in Canada. Not to exclude the rest of the world, obviously, but it will also have profound implications for public policy. I have identified five different areas in which I think this will be of interest to you.

The first area is patient privacy, and Dr. McLennan identified the act that pertains to that. The example that I have chosen gained some international notoriety - Decode Genetics, a small biotech company started by Professor Kerry Stephenson, Harvard University, who originally hailed from Iceland. The issues around the identification of returns from the study of that discrete population are still waiting for some delineation and solution. Certainly, it is a controversy that is well known by the government of Iceland and internationally. It has not yet been decided.

Closer to home, we have several initiatives in U.S. legislatures, which, of course, are designed to protect people against the use of genetic information. I will leave it for you to contact me so that we can provide you with a recitation of those.

In our industry, we have established some general principles for genetic research. Ethics committees must approve all trials; patient participation is voluntary; only coded numbers are used to protect privacy; no results are returned to families, employers or insurers; and data is shared with the scientific community through journal publications, where anonymity is preserved.

In the area of public awareness, it is extremely important that the public policy discussions shed light on the issues surrounding genetic research, as opposed to the heat that has been generated mostly by a very top-over type presentation of the prospects of genetic research. Today concerns about genetic research in medicine, animal cloning, embryo research and genetically modified foods are mixed in the public consciousness. It is vital that the level of public understanding be increased so that the role of genetics in medical research is separated from the sensationalism that often follows newspaper headlines.

The second area deals with drug development and regulatory requirements. As everyone knows, the regulatory process currently is long and drawn out. It should be safe, and it should ensure that our products are very efficient and effective. However, at the end of the day, the Canadian standard of performance lags far behind our international competitors. With the genetics revolution, where there will be a speeding up of discoveries and a need to get these products quickly to patients, we will need the regulatory world in Canada to respond to the needs of the patients, as well as the demands of the new science that is being turned out.

Ultimately, our paper suggests that public officials need to appreciate that more resources are required to ensure that Health Canada can make the necessary changes to keep up with the changes in science and to make additions to a department that is already struggling because of previous funding constraints.

Next I turn to protection of intellectual property rights. This area is one that becomes more contentious in the Canadian context and could be discussed the remainder of today, tomorrow and perhaps the rest of the year.

From 1969, when there was an implementation of compulsory licensing, until 1987, with the introduction of Bill C-22 and then ultimately its follow-on legislation, C-91, Canada has approached a minimum standard of international patent protection. It is extremely critical not only for our industry, which is global, but for the new start-ups in research, and particularly genetic research, to be able to count on protection for the labour of the researchers in that field. This is critical if Canada is to take advantage of the markets that were identified by Dr. McLennan.

More than that, it is important for people to understand that our industry does not support the idea of patenting genes. What we are in favour of is not the ownership of individual genes but of the knowledge of how to deal with the genetic research and to implement the changes that will be positively received in treating people with diseases or in treating people to prevent the onset of disease.

Another issue of obvious importance, and I presume one of the reasons why the honourable senators have been gathered, is the impact on health care costs. I worked in the world of managing health care - but I ought to, as should most of us who are former health ministers, put "managing" in quotation marks. In the years when I was involved with then-treasurer Bob Nixon in Ontario, the Department of the Treasury was quite concerned about breaking through the double-digit expenditure on health care in Ontario - that is, into $10 billion. Now in Ontario we are at $22.2 billion. I suspect the issues are the ones that grab the headlines almost everywhere. I presume most health research initiatives sponsored publicly will be dealing specifically with the sustainability of our system.

Let me make one comment that is not in the paper - it is personal as opposed to corporate in nature. I struggle on occasion with the fact that some people have loaded up the criticisms of our current system to an extent that they feel it is in some ways broken in its current condition. In fact, the current health system, designed as it was many, many years ago, has actually performed much better than it was ever intended to. We are doing a huge amount of work that was never even speculated upon when the system was first put together in the 1960s. While we may be unable to see how our system can evolve to take on new responsibilities, provide new treatments and other things, it is a demonstrated fact that our system - as slow moving as it might be in some cases - has responded to what has been in the last 15 years a huge change in the way that health care has been delivered. This response applies to both the manner in which health care has been delivered and in the selection of the items that can be administered to health patients in this country.

In other words, the system is delivering far more than it was ever intended to, because we know more things to work on now than we did some 40 or 50 years ago.

I am not as pessimistic as some people. I am concerned that patients get the care they need. We must work cooperatively to ensure that outcomes is the focus of any kind of public-policy debate and not just a fiscal scrutiny that would gravitate toward what some would see as the cheapest version of health care. I leave that as a personal observation.

I go back to the genetic research and the interesting things it presents to us. As one becomes more sophisticated in the manner in which one takes on research, one will get into more sophisticated applications of technologies and more sophisticated identification of discrete populations that, at the end of the day, may result in smaller populations who will make use of the new medications that are discovered. If current circumstances carry through, the products themselves may be more expensive than ones we are seeing now.

If we have a regulatory system that extends the time under which we are languishing in trying to get permission to make these products available to the public, we will find that that in itself will result in higher costs in the field of health care.

Let me move quickly to the public funding of medical research. Our brief describes, generally, some of the elements of comparison between Canada, France and the United States. Let me say that Canada has taken the steps - and I agree with Dr. McLennan on this - that put us into the game of keeping pace with the medical research. I would like to say that medical research on its own and the funding of it from a public point of view is a situation where Canada finds itself in a catch-up mode. The right steps have been taken and the right pronouncements have been made. If I might say so, the last federal election was an interesting one for us to watch because there was support, at least among the major parties, for pushing Canada into the knowledge-based economy. There was an earnest desire to have us at the forefront of the knowledge-based economy. There was an acknowledgment that this is the new way for Canadians.

What has to be made clear is that Canada is entering into the global competition behind several other well-organized and very determined countries who have already decided that they will put in play the critical mass that makes research in various areas much more attractive for investors. Therefore, I urge not only that we continue the course but, as Canada shoots for number one status in this area, we must be prepared to make the tough public policy decisions that permit investments even at a higher level if we are to retain the people that we have.

I will end there, Mr. Chairman, and welcome your questions.

The Chairman: Thank you. Before turning to the Deputy Chairman, Senator LeBreton, to start the questioning, I would like some further information. If you do not have it now, you can send it to us.

Dr. McLennan, you recommended that a public awareness campaign be undertaken to explain to Canadians the benefits of biotechnology. I have been searching for, but have been completely unable to find, a layperson's understanding of what biotech and genomics are. I have a scientific background and have been able to read some things.

A public awareness campaign could not be undertaken unless there is material that, at least at the beginning, can be understood by the educated layperson. If that material is available in any form, can you send it to us? It would be very useful to the members of the committee.

Perhaps you want to comment on that. I have been looking for such material and have not found it. I keep asking people but they cannot seem to find it.

Dr. McLennan: I think you are right, Senator Kirby. There is not a nice, neat package. That is part of the problem. As Mr. Elston said, we as a community get beat up in the press with dramatic headlines that gloss over facts and individual statements, and the public becomes confused.

I would like to suggest that we contact the communications office in CIHR. I am not sure whether it has put this material together. If we have not done it, as a health research community we should do it.

The Chairman: By the way, you will not get a lot of sympathy from us for being beaten up by spectacular headlines. It is congenital to our occupation. I say welcome to the club.

Senator Morin: Several months ago there was a specific issue of Scientific American magazine on genomics that was very good.

The Chairman: Simply telling people it is glitzy and it is good is not even as effective as the Canadarm, which at least one can see.

Mr. Elston, I agree completely with your fourth point on the impact on the health care system of moving towards treating people individually rather than as part of a group.

What evidence have we got and what has been written on the impact of the developments of using genetic backgrounds to target treatment? You say it will have serious cost implications, which seems likely. Is anything available anywhere that - even in a ballpark sense - has expanded on your two paragraphs?

Mr. Elston: We have some information that is more exclusively identified with some new products that are occurring. For instance, some of the genetic research that is being done is being used now for diagnostics. Instead of taking several weeks to get diagnosis, you can shorten the time period. There are, in that sense, some savings.

I do not know that I would be able to identify a piece, but perhaps I can work on expanding those two paragraphs if you would permit me.

The Chairman: That would be helpful. A number of us are aware of examples where biotech drugs have recently been used. For example, where chemotherapy used to kill both the good and the bad cells, these new biotech drugs kill only the bad cells. There is no question as to the increased cost. In the one particular case with which I am personally familiar, because it was in my family, the cost of the drug was $3,500 a shot. That was once a week, for four to six weeks. That makes it easy for me to believe your increased cost line.

It would be useful for the committee's report, the more information we could get.

Senator LeBreton: My question was precisely on the point that Senator Kirby raised on Dr. McLennan's recommendation of a public awareness campaign. How would this be done? More importantly, if we embark on a public awareness campaign, will this not then prematurely create expectations in the public that the new technologies cannot meet, or worse, put pressure on researchers to rush that period between the time of discovery and marketing?

I was watching a piece on 60 Minutes on Sunday night in regard to clinical trials. If you educate the public about these new sciences and people are in desperate situations, you create an unwanted pressure on the whole clinical trial area.

When we talk about public awareness, is it perhaps something that could also work to the detriment of the science?

Dr. McLennan: Last weekend, the colleges of medicine in Canada, ACMC, had their annual meeting in Toronto. One of the presentations was on genomics. One of the presenters, spoke about what we must begin to do to educate medical students about the new genomics and genetics. Part of this public awareness campaign must start in our universities. We must do that right away, because these students must understand the jargon so that they can speak intelligently with their patients about it.

As a biochemist, I teach genetic engineering to my students. I know that in a class of 500 students, perhaps 10 per cent of them will become biochemists, but that is not the point. Every one, as Canadian citizens, should understand the fundamentals of genetic engineering, the potential benefits and so on. All of us, whether we like it or not, are walking around with mistakes in our genes. Most of it does not matter, because we have so much redundant DNA it will never show up. Ironically, the fact that we all have nicks in our DNA means that we are all unique. That is why DNA fingerprinting is such an excellent way to identify an individual.

Everyone should understand the science in lay terms and understand the potential. I do not think we should ever hesitate to tell people the truth about the potential of new research findings and treatments.

I share your concern in this sense, that if I go in to see my doctor and he says, "You have a set of genes that predisposes you to colon or prostate cancer," and I say, "Fine, what can you do for me?" He will say, "Well, nothing yet." That is probably a truthful statement. However, no one can predict how quickly the profession will be able to improve treatments, regimens and so on.

There is no hesitation in my mind to providing the information and getting it out in the public. People have a right to know. There is nothing to fear there.

What bother me are the sensational headlines that scare people. This returns to Senator Kirby's first question: how do we educate people? That is a challenge for all of us. Scientists and researchers are becoming much better at devoting more time to talking about the benefits of research and so we should. There is a long way to go yet.

Part of the problem is time and part is funding, but those are not acceptable excuses to me. Whether we start with the textbooks, or clips on the Discovery or Learning Channel, we must do it.

Senator LeBreton: The other part of that is the pressure it puts on the researchers because if the public is educated, there is an expectation that there will be a treatment soon to hit the market and they are waiting. I wonder what that does to the people who are charged with the responsibility of developing a particular drug.

Dr. McLennan: It is no different than the pressure on physicians today when someone comes in and they expect instant cures. Everyone expects to leave the office with some medication. The over-prescription of antibiotics comes to mind. Why does that happen? Part of it is pressure. The patient comes into the office and expects the doctor to do something for them. Sometimes there is nothing they can do and the best thing is to go home and have a drink of juice and get some sleep.

There is pressure, and one should not promise more than one is able to deliver, but this is a cumulative process.

Mr. Elston: I do see a positive element in that pressure; that type of pressure sustains the need for critically funding particularly our public sector universities at all levels. We have slipped in sustaining the level of activities in those areas. I am not a scientist, and that is both an unfortunate and perhaps positive event, because I do not have any personal benefit to get from this except as a member of the public.

We must be aware that the pressure to find new and better outcomes for patients, which is driving what is excellent research in Canada, must be now sustained by a public answer to permit these people to do work in a better and broader fashion.

While people are waiting for these discoveries to become publicly available, it will drive the public policy to say that we have a stake as a government - both as a funder of health care and also as managers of the well-being of society - to get involved in a much more direct and positively financial way.

Senator LeBreton: My next question relates to the rapidly changing world and new technologies. I asked this question of the radiologists when they were here.

People going through university today are able to receive up-to-date information on biotechnology and genetic research. What about medical practitioners in the field at present? How are they brought up to speed?

Mr. Elston: It is important that we renew our professional groups and participate in helping others to improve their access. I defer to the honourable senator who knows more about this than I do, but new graduates from medical schools are critically involved in electronic and information technology. Some existing practitioners are adopting IT in massive new ways. These are critical tools for making sure that people remain current.

May I make one observation? This raises the question: how do we keep our professionals involved in updating when this profession, over the last 35 or 40 years, has already seen tremendous changes? They have demonstrated an ability to keep pace, though not without difficulty. We have provided some useful tools to sustain them in the changes, but we entrust to certain people, like Dr. McLennan, the teaching of the next generations in the use of necessary tools.

Returning to my observation about the failings apparent in our health care system, the introduction of new technologies into the system has always caused concern and stress. Yet, we have taken on these new technologies, the new therapies, the new pharmaceuticals, the use of CT scanners and MRIs and other such things. While we should continue to discuss how best to introduce such new tools, I urge people not to run scared from new technology. New technologies have allowed us to make quantum leaps in providing good outcomes for patients in ways that our Canadian pioneers could never have foreseen, such that certain diseases now no longer kill people.

Do not be afraid of new technology. Do not fear the ability of the profession to keep pace, despite the struggle. We have demonstrated in recent years just how well we cope. We may move slowly at first and we may need support, but we are in very good condition, in my view.

Dr. McLennan: The concern about practitioners or professionals keeping up to date, regardless of profession, is not new. We have in the medical world, continuing medical education programs, seminars, conferences, refresher courses and programs for individual practitioners.

Clinical practice guidelines are developed from time to time. Accreditation programs ensure certain standards in the teaching of medical students and other professionals. However, professionals must take the initiative to keep themselves up to date when the information is presented. Most people are responsible enough to do that.

I agree with Mr. Elston that we should not fear change. History has shown that we do successfully adapt to new technologies and our health care system benefits from that. Despite all the complaints about health care in Canada, we have an excellent system. Yes, it needs some fine-tuning, but we can do that.

Mr. Elston: I have heard about an Internet experiment undertaken by a physician in Strathroy, Ontario, which is bringing together a group of rural physicians. As their time allows, they can consult each other on their different cases over the Internet and share their observations. That type of interaction was not possible even a few years ago. Now it is helping professionals to remain current and to be involved in the kind of peer educational activity that reduces concern for the practitioners because they can share their problems and find solutions together.

I find that to be an absolutely amazing development. It was not generated by any policy document saying "thou shalt" but it arose from a need, and now it is diminishing the isolation of some rural practitioners.

Senator Fairbairn: I want to add a dimension to the discussion on awareness and public understanding. I take your admonition that we not be afraid. We saw a vivid example of that fear at work in another Senate committee several years ago. We had moved into a few supposedly innocent hearings on bovine growth hormone. Suddenly we found ourselves overwhelmed. We faced a fear that was based on a sense of not understanding and also based on the vital connection of the subject to the daily lives of most Canadians. That subject was milk.

We saw a torrent of anxiety, fear and abuse all over because people did not understand the issue. Even in the end, I am not sure the understanding came but we as a country decided not to approve the use of the hormone.

I was left with a real anxiety about this rapidly growing area of science. It is so technical and so complex and so far from the ordinary scope of language and comprehension in our daily lives. For the health care system and the doctors in it, technology is one of the most potent challenges - even with all the good things it brings. I agree with you, Mr. Elston, that we do have a good system. Much of the anxiety in the debate arises from our lack of understanding and so the debate may seem at times to attack the system.

I want to raise an extra element, which affects my life greatly, and that is the large number of Canadians who have difficulty in reading, in writing, in understanding in a functional way, some of the most routine things we take for granted as part of our daily lives. Over 40 per cent of Canadians face varying degrees of difficulty in these routine activities.

When you discuss public awareness and public education in your professional groups, you must factor in the 8 million Canadians who cannot read and understand properly the messages sent out on television and, particularly in print, about most of our new discoveries and new patterns of activity. Many people in Canada do not understand what is happening. Nowhere is that lack of comprehension more frightening than in the field of medicine, from biotechnology to reading a prescription on a drug bottle.

It is not just your good old public awareness campaign that we have all been involved, in one way or another. Public education sounds great. You pump out the material and think, "Okay, we have done that. Get on to the next thing." You have to know before you go in that, with the regular routine way that we have communicated, you are not reaching them.

Mr. Elston: That is the challenge for us. Particularly for our industry, it is absolutely critical that there is a good explanation. We have actually developed some programs where we have provided material that forms the backdrop for presentations by physicians or pharmacists or others who visit groups of individuals - for example seniors or a group of employees in an office structure. The programs consist of a verbal presentation as well as some written material, and then there is an aide to help keep their medicines straight.

The interesting thing is the intervention of some programming, especially TV channels. I think the Discovery channel is a wonderful tool. I understand it will not reach everyone, but it does attempt to popularize the discussion of some interesting scientific areas. From time to time, I have gone through some of their presentations. The presentation that was done on the History channel about the discovery of insulin in Canada was an excellent profile. Those types of interventions, which are more in the tradition of a verbal explanation of what is going on, are aids to us. They are not solutions, but in our world we have to make sure we do not forget any of those vehicles.

Senator Morin: I congratulate you on the remarkable work you have been doing over the years.

You recommend investing 1 per cent of the total health care expenditure in Canada, which is about $86 billion, in health research. What would be the effect on the quality and cost of our health care system if we did that?

I would like to make a comment, Mr. Chair. Mr. Elston, as you know, is Chairman of the Canada's Research-Based Pharmaceutical Companies, which is really putting up a fight - which I think is very important at the present time - as defenders of intellectual property rights. There is a very close link - I know we are not talking about this today - between those rights and health research in this country. I hear there is a possibility of this being considered again in the fall. I would hope that this would come to this committee and not to a committee that is strictly interested in finances and banking, as it has in the past.

The Chairman: I do not disagree with you at all on that. I would be happy to raise that with Senate leadership.

Senator Morin: According to public ministerial statements, and Mr. Elston probably knows about this, there may be a review of the whole system.

Mr. Elston, I have two questions. It costs $750 million Canadian for a drug. How much of it is non-clinical, and how much of it is clinical, approximately? In the billion dollars that your organization spends in Canada, how much is basic? If you do not have the answer, you could send it to the committee. I think that is important. How much is basic, and how much is clinical?

You referred, and I think are you quite right, to the problems of the regulatory process in Health Canada. What are the effects on our health care system of these problems at the present time?

Dr. McLennan: On your question on the 1 per cent, if I may, Mr. Chairman, the notion of 1 per cent as a reasonable portion of investment in health research compared to our total health expenditures is not a new idea. Many jurisdictions around the world have pushed this notion. I might add that the Fyke commission, which reported recently in Saskatchewan on health care, recommends 1 per cent, and I was happy to see that.

Why 1 per cent? The first point is that investing in health research gives you an immediate win-win situation. First, most of the research money goes to pay salaries; that creates jobs and pays taxes. Second, you will immediately address the brain-drain issue in this country and keep our bright and best in Canada. However, the big win for all of us, as Canadians, is that that investment returns a benefit in providing better health care. In other words, the delivery of health care depends on having the best treatments and the best procedures in place and so on. That is research. We use the phrase "evidence-based medicine." What does that mean? That means that you practice medicine on the basis of evidence, which is the research. There is an immediate win-win there.

One per cent of the Canadian health care expenditures would be roughly $1 billion. Even with the increases made - and I compliment the Government of Canada for doing this - for CIHR funding, we are less than $500 million. We are a long way from 1 per cent, even now. The game plan, as I said in my comments, was to wrap up to 1 per cent. Many people say that by the time we get there, perhaps the number should be 2 per cent, but it does not really matter. The point is that you get a return on that investment right away, and that is why it makes such economic sense. It makes health sense to invest 1 per cent.

Mr. Elston: I will provide a breakdown at a later date on the clinical basic research and the numbers associated with that investment of $1 billion dollars. I can say in relation to the material that, prior to the introduction of Bill C-22, we were doing about $100 million worth of research, and now we are over $1 billion. We have grown. We have collaborations now. This is a bit of an advertisement for another group with which I am associated in a partnership in terms of representing Rx&D, and that is with the CIHR, which is the new iteration of the MRC. We have developed a collaboration that has been expanding the partnerships of the public and private sector to have a fund and peer-reviewed research.

Regulatory delays two effects on us. They prevent products coming to our patients here in Canada as quickly as they should. I think a good example is a product for the treatment of asthma, which was discovered in Montreal. It was applied for approval at the same time in Canada and the United States. The United States was number one in the approvals of that product for use, and Canada was number 29. The cost or the effect of a product that has helped a number of people had been the fact that they had been without it and were delayed in receiving it against other people who should have received it.

The other issue is a more interesting one for us. When people confront the Canadian regulatory scene they will look first particularly in the biocompanies, which are coming very close to launching products in that way. There are a number of success stories in Canada waiting to be identified. They are looking now to the United States to get their approvals done, because not only can they get a more efficient system in the FDA, but they also have a system that is effectively assisting them understand what the regulatory process is about. In Canada, there is an aloofness that prevents the type of assistance to these small companies that do not necessarily have all of the elements of understanding of the extremely difficult or complex regulatory system.

We have two costs. The first is delay. Second, we have a loss of perhaps the ability to keep those biocompanies here in Canada. It is a shame to lose the ingenuity that has come so close to successful launches by seeing another jurisdiction pick it up as a result of what are just some barriers that can be straightened away without a lot of effort.

The Chairman: I thank the witnesses for coming. Let me make one comment. I do not want to get into a debate. Dr. McLennan, on your recommendation on the Personal Information Protection and Electronic Documents Act, I do not think there is any chance that the federal government will agree to set up a task force. Let me be very clear on why I say that.

This committee went out on a limb 18 months ago and took considerable negative comment from the minister on down, because we amended the act to give a two-year grace period. Even for those of us who recognized the problems of applying the old Bill C-6, it is very hard to be sympathetic when, 15 months after we gave everybody 24 months, people said that we needed a task force.

The notion of an extension is probably not in the cards. Our intent, when we gave people the two years, was to keep their feet to the fire. If they did not respond, then so be it. We are sympathetic to your problem and that is why we gave the 24 months. The people in the research community had better move quickly and come up with a solution to the problem, otherwise you will be stuck with Bill C-6, which none of us wants. However, having given you 24 months, it is not unreasonable that we expected someone to come forward with a solution by now. I do not want to debate that, I just want to pass along some free political advice.

Dr. McLennan: Your comments are well taken. We do not have time to talk about the history of this and it does not matter. We have to deal with the issues on the table. We have had meetings with Industry Canada officials recently. The problem is this: What is defined as "commercial activity" is unclear; what is defined as "identifiable individual" is unclear; and the interpretations will be left up to the Privacy Commissioner and the courts. There is not a researcher in this country that would want to begin a research project with those uncertainties.

The Chairman: Various members of this committee have said that until the research committee comes to us with the definition that they want on those two questions, our hands are tied. If someone can come up with the legal drafting that will deal with those two issues, we will do it by regulation or, if need be, we could try to amend the act, although that is a pain. I believe it is doable by regulation. However, so far, everyone talks about it and they all wring their hands, but nobody puts pen to paper to state the legal way to deal with the problem. You cannot expect us to do that, since you are the ones who understand the problem. I leave that with you with a pleading that you come back before us with an answer that we can work with.

Our next witnesses are Dr. Pat Armstrong, National co-ordinating Group on Health Care Reform and Women, and Dr. Ronald Worton, Associate Director, Canadian Genetic Diseases Network. Dr. Worton is also the CEO and Scientific Director of the Ottawa Hospital Research Institute.

Dr. Pat Armstrong, National Co-ordinating Group on Health Care Reform and Women: Thank you. I feel that it is a bit of an odd marriage, the two groups represented here today. I hope we can make the leap.

I am here on behalf of the National Co-ordinating Group on Health Care Reform and Women, which is a collaborative group that brings together the five federally funded Centres of Excellence for Women's Health, the Canadian Women's Health Network and Health Canada's Women's Bureau.

We are here to talk about health research, not as it relates to treatments and drug therapies, but rather to the future of the health care system and the impact of changes on women, men and children in quite different physical, economic, social and cultural locations across the land.

Our mandate is to coordinate research, identify gaps and link research to policy as well as to fill those gaps.

We started with the assumption that health care is a women's issue. Women provide 80 per cent of the paid care and a similar proportion of personal unpaid care. They are the majority of health care recipients, especially if we talk about the elderly, but they are only a minority of the decision-makers at the highest policy level, in terms of health care. We are interested in the consequences of reforms for women as providers, as patients and as decision-makers, but we are also quite aware of the differential impact for women as relates to their physical, social, economic, cultural/racial locations, as well as their age and sexual orientation.

We wanted to know which women are affected in what ways, and by which reforms. When we started to look at these questions, we, like you, found a great deal of complexity and that we were talking in quite different languages. We set, as one of our tasks, a scan of what kinds of health care reforms were happening across the country, as well as what we know about their impact on women.

I would like to share quickly with you the major conclusions from those scans, and then, perhaps, we will have some time to discuss them.

The first conclusion is that the privatization of the health care system is a primary strategy in terms of health care reform. This has been happening for more than a decade. We defined privatization in ways that cover a range of activities that are not usually associated with the term. We talked about privatization of the cost of health care by shifting the burden of payment to individuals and private organizations. We talked about the privatization of delivery in terms of the shift to for-profit health service providers.

We also talked about the shifting of care from the public institutions to community-based organizations and private households. We talked about the privatization of care work, whereby the work would be removed from the public sector health care workers and added to the unpaid care providers. We also talked about the use of management strategies taken from the for-profit sector and applied to the public health care system.

We found that all those strategies were being used in various ways throughout the country.

Second, we found that while there were real similarities in strategies, there were also significant differences, including some reversals of the privatization process. For example, in Manitoba, an experiment with for-profit home care was reversed, and in Ontario, public services were extended to midwifery services.

Third, we found that reform is happening so quickly, and with so little public information on the changes, that it is difficult to draw a full picture of health care reform. We advocate more research on privatization. We also need to know more about its forms, as well as about its consequences for individuals, groups and the system as a whole.

Fourth, we found that outside of the research being done in the Centres of Excellence for Women's Health, there is little research that examines the impacts of reform on women. There is even less research that considers the differences among women, in terms of the impact of reform. The question of women is seldom asked and even more rarely answered.

Fifth, we found that the research that takes women into account suggests that many of the health care reforms are having a negative impact on women. Those performing paid health care work are facing increasing workloads and increasing stress. I would say that the largest occupational category relevant to the brain drain has been nurses. More women are being conscripted into unpaid health care work, as they told the National Forum on Health, and do so without training and with few supports.

Those who are sent home quicker and sicker are finding it more difficult to receive care. Important questions need to be asked about the quality of care they are receiving, not only at home, but also in institutions.

The kind of complex care that is being sent home is putting a great deal of strain on women, and there is a long quote in our formal presentation that gives you an idea of the kind of care that is being sent home.

The research on differences among women, although even harder to find, suggest that those who have been traditionally the most vulnerable are facing deteriorating conditions for care. Aboriginal women, for instance, who have been a particular concern in the Centres of Excellence, are facing a whole range of difficulties as a consequence of reforms. Rural women find it very difficult to provide care under existing conditions. User fees are particularly problematic for the many women who are poor and who make up the majority of the poor.

Sixth, these reports clearly demonstrate the need for research on the impact of health care reforms that is gender-sensitive and women-specific; research that begins with the recognition that women and men connect to the health care system in different ways and that there are also important differences among women. What counts as research also needs to be questioned. Taking women into account requires much more than calculating and analyzing data by gender.

Finally, the research demonstrates that there are real choices in how health care is reformed. Women need appropriate evidence and need to fully participate in making those choices. However, it is also clear that context matters in research, in policy, and in practice. The trade agreements we have been hearing so much about lately are critical in establishing the conditions for health care, as are many other international transactions. We should not be undertaking reforms without assessing how these reforms will be transformed into practice under existing international and national conditions, and without assessing the impact on women not only as providers and patients but also as decision-makers.

What do women want? They want services that respond to their needs; needs that vary depending on where they are located. They want quality of care that is defined in their terms. They want recognition of the impact on caregiving in their own daily lives. That means it is very important to think about the long-term costs in terms of costs to relationships and to values as well as to the economy.

We think our research should be a warning against further privatization of the health care system and the importance of recognizing the impact on women.

Thank you.

The Chairman: Thank you, Dr. Armstrong, for a not-unprovocative paper.

Dr. Ronald Worton, Associate Director, Canadian Genetic Diseases Network: Dr. Armstrong is right; this is an unusual grouping of two people. I certainly will change the topic a little bit here.

I was asked to come here on an invitation that was extended to the Canadian Genetic Diseases Network, of which I have been the Associate Director for many years. I accepted the invitation for that reason.

I have also recently become involved in a new network, Network of Centres of Excellence. On the handout I have given you, these two networks are listed on the front page. The first one, the Canadian Genetic Diseases Network, has been in existence since 1989. It was one of the original Networks of Centres of Excellence. It has successfully gone through two renewals, one of the few that has done that, and is still studying genes involved in disease.

It receives about $4.5 million annually in funding. It has created seven spinoff companies over the last several years. The four themes of research are related to gene discovery, the pathology of disease that results from abnormal genes, gene-based therapies and population genetics.

The other network I am representing here today is the stem cell network. Most of you may not have heard of this network because it is new. It was only announced in March of this year. I am the scientific director. It is the result of an application we put in last fall. The network recognizes that the future of research and the future of many treatments may well depend on the use of stem cells. It is a controversial topic, particularly with regard to embryonic stem cells, as you will appreciate. I will elaborate shortly.

That network has about 50 scientists across the country. We will be receiving about $5 million in funding when we get all of our agreements in place. We will be tackling four themes. The first of these themes is the social, ethical and legal issues regarding the use of stem cells in research and in health care. The other three relate to stem cell biology, and the bioengineering of stem cells to make them useful for therapeutic applications. The last topic is stem cell therapeutics.

I indicated on the front page the third institute I represent, which is my "day job" - my paying job - and that is as the Director of the Ottawa Health Research Institute. This also is a totally new institute. It came into existence on April 1 following the merger of two pre-existing institutes: the Loeb Research Institute, located at the civic campus of the Ottawa Hospital, and the Ottawa Hospital Research Institute, which I previously directed at the general campus. You can see the seven programs of research listed there. I will not go into those.

There is a short biographical sketch on the second page. You can read that yourselves.

There are two speaking points I wanted to make. On the third page they are numbered 1 and 3, which simply tells you I cannot count.

The first one was to tell you a little bit about the impact on health care of genetics and stem cells. I did not bring a long multi-page brief. I can provide that if you want. I have written many of those in my days. The Genetic Diseases Network can provide them in any of 20 different flavours. I will leave it for you to give me some guidance about what information you would like from us.

The only points I wanted to make is that genes are tremendously important in disease, far more than we appreciated 15 or 20 years ago. We used to think that genes were only involved in diseases that are inherited. We have known that for a long time - cystic fibrosis or sickle cell anemia are good examples.

However, over the last 15 to 20 years we have come to appreciate that genes are involved in virtually all diseases. Diabetes, for example, is not strictly inherited, but your susceptibility to diabetes depends on some dozen or so genes, and the alterations in those genes in the total spectrum determines, to a large extent, your susceptibility to diabetes. That may be coupled with other environmental factors, such as diet and other exposures, but nevertheless, genes do play a role.

It is the same with virtually every other disease you can think of. Heart disease, virtually all forms of cancer, lung disorders such as emphysema and asthma are all conditions that have strong genetic components.

The big difference between now and a decade ago is that we are beginning to understand what these genes are, what the function of the genes are in the cells, what proteins they make, and what the function of those proteins are. I have referred to these in the handout as the "genetic determinants of susceptibility."

Knowing these determinants, we begin to understand within ourselves what the determinants are that make us ill or susceptible to illnesses. We begin to understand how those determinants make us susceptible.

Knowing that goes a long way towards understanding the disease mechanisms. We already understand the mechanisms now for several hundred diseases, with several thousand more to go. That understanding is already leading to new diagnostic tests and, to a lesser extent, new therapies. Fifteen years from now, I predict, the diagnostic tests will be behind us and we will be looking at a very broad spectrum of new therapies based on those discoveries.

The other point I have listed there is the importance of stem cells in tissue regeneration and repair. In all of our tissues we have cells called "stem cells." If you tear some of your muscle by over-exercising - as I do periodically as I do not exercise regularly enough - your muscles become store and stiff. Some of your muscle fibres become torn and damaged. It is the stem cells in your muscle that move into place. Those cells fuse in with the existing muscle and they actually create new muscle.

Similarly, your blood is being renewed all of the time by stem cells in your bone marrow. They are constantly renewing themselves and undergoing a process called "differentiation," where they make red and white blood cells. Stem cells are terribly important in those tissues.

There is a more primitive cell, called an "embryonic stem cell," in the embryo, that is capable of making any kind of tissue. We know that because you can take a single stem cell from a black mouse, put it into a growing embryo of a white mouse, and out of that you can regenerate an entire black mouse from that one stem cell. We know that one stem cell is capable of regenerating an entire organism and doing it properly.

There is recent evidence, and this made me quite excited two years ago, that adult stem cells may be able to do the same thing. We do not know all the details yet. We do not know how it works. We do not know how uniformly applicable it will be, but in the mouse, people have taken stem cells from bone marrow, where they are supposed to make blood, put them into the muscle and they make muscle. Where they have taken them from the muscle and put them into the bone marrow, they make blood. In other words, they can exchange for one another. Bone marrow stem cells can also regenerate brain.

As you can appreciate, this has huge potential. If we can understand how the cells do this, if we can manipulate those processes and make them generate tissues at will, then we have a mechanism for repairing the damage that is done in degenerative diseases. Such diseases include Alzheimer's, Parkinson's, and neuromuscular diseases, muscular dystrophy, spinal cord injuries and all kinds of things. That is the hope and the basis on which we put in the proposal for this stem cell network that was recently funded.

The whole purpose of this is just to make you aware. These are two big areas. They will have a large impact not only on research, but also on health care. We are at your service to help you understand these issues as long as we know what you would like to have from us.

The level of funding for health research in Canada has undergone a dramatic improvement in the last five years. Senator Morin, with whom I have worked closely on the interim governing council that created the CIHR will know even better than I what I am talking about.

I will single out three federal government initiatives. The Canada Foundation for Innovation, CFI, contributes greatly to infrastructure. Every university and teaching hospital in this country has taken advantage of that funding and received several million dollars to build new space and create new infrastructure. Many of the provinces have provided matching funds to go with that. If CFI provides 40 per cent and if the province provides 40 per cent, I only need to go to the public for 20 per cent. That makes it much easier.

The Canadian Institutes for Health Research, CIHR, has made an enormous difference. First of all, it is a new paradigm. The MRC was a very reactive organization; it would wait for applications to come in and fund the best ones. CIHR is a proactive organization; it is determining a research agenda and what kind of research is best for this country and then enacting that research agenda. That is not to say it does not still fund research applications that come in that are unplanned, but the planning process is now part of CIHR. CIHR integrates the four pillars of research. The MRC used to be basic and clinical research. The new institutes are now basic, clinical, population health and health services research. Integrating those has led to some innovative proposals.

The funding for CIHR has almost doubled. By next year, it will be doubled to approximately $500 million. The Canada research chairs that started last year have made an enormous difference in people that we are able to recruit and retain in this country. The best people are seeking Canada research chairs and when they get them, they are not going anywhere; they will stay in Canada.

What is required? I have just put two or three bullet points at the bottom. I just wanted to emphasize CIHR. CIHR was a bold venture when it was conceived three years ago. Our objective in trying to build the CIHR was to raise the level of funding for medical research to $1 billion per year. That is what was asked for and sought in the original proposals. That was based on a comparison with other countries, a definition of the need and an evaluation of our capacity for research.

The federal government responded with a doubling of the budget to $500 million, which I think everyone accepted and it was a wonderful change from the previous decreases. However, I am still advocating that we need to reach $1 billion. That would be a level of funding that would make us very competitive with the United States, most of the major health research intensive countries in Europe, and so on.

We are somewhere in the neighbourhood of one-quarter of the spending on health research through agencies of this kind compared with the United States on a per capita basis. We still have a way to go.

I would urge that we continue the CFI and the Canadian research chairs. They are wonderful initiatives. They have helped enormously and we need to keep them going.

There is much more that could be said. I decided I would focus entirely on genetics and stem cells and the funding issue. I would be happy to answer questions.

Senator Pépin: Dr. Armstrong, I do not think that you have to convince many of us, because we are mostly women, and your presentation was very good. I wish that you would appear in front of an all-male committee, because I think the impact would be significant.

I am part of a group of parliamentarians who are seeking gender analysis of every piece of legislation. We want to see the impact on women. We know how important health care is.

Senator Cohen: Dr. Armstrong, in view of the fact that you say there must be more research that assesses the consequences of privatization on women, and because there is little research out there but for the research that is done by the five centres of excellence, and that your funding is almost coming to an end, and that Dr. Worton says the level of funding has undergone a dramatic improvement and he gave the statistics, what will happen to the five Centres of Excellence for Women? You have proven how vital they are for 50 per cent of the population.

Dr. Armstrong: We do not know what will happen to them. I certainly hope that they get further funding, because they have been very important in terms of creating a research capacity in this country, that we are only now starting to realize. We are just in the initial stages of creating teams of people who can produce the kinds of research we need, not just research that looks at women, but also recognizes the significant differences across the country and amongst women.

It is very important that we continue this funding. It is not adequate to rely on the CIHR for gender. The CIHR has a specific mandate to look at men and women. It is very important, and we have demonstrated that through the centres of excellence, that we do need a specific focus on women as well.

Senator Cordy: As Senators Pépin and Cohen have said, the women on this committee are delighted to read the documentation that you have provided to us, Dr. Armstrong.

I would like more information on the role of women as caregivers. We all know that the role of caregiving - whether to a parent, child or whatever - tends to fall on women. Your documentation says that women want recognition of the impact on caregiving and strategies to address their concerns.

Is there research being done relating to the effect that caregiving is having on women in terms of stress and those types of issues?

Are there good things happening in any part of Canada where communities are aware of the effect of caregiving on women and providing respite care?

Dr. Armstrong: There are a number of questions there. Certainly research is being done on women as caregivers through the Centres of Excellence in Women's Health. The maritime centre of excellence has just applied, successfully, for a grant to look at women's paid and unpaid caregiving work. I think we will learn a great deal from that project. I am actually part of that application as well. They are interested in looking at strategies to address these issues and not to just look at the problems.

We are getting a sufficient amount of research demonstrating that the impact is negative, and I think that it is very important now to think about what strategies could work. Much of the emphasis has been on providing support to keep women providing that caregiving work. They are much less concerned with creating this as a choice.

I just finished a survey of the literature on caregiving among adults. There is very little research, if any, on the impact on relationships of this transfer of care work into the household, and especially onto women. If we are really interested in supporting households and relationships, then I think it is very important to look at the consequences of caregiving on those relationships. I supervised a thesis not long ago on caregivers amongst adult schizophrenics. Almost all of them were women. In fact, all of them in this study were women. In every case, the marriage had broken up. It is important to look at these kinds of consequences over the long term. If we want to think about costs, this is an important long-term cost.

Research out of Quebec, connected to the centre of excellence there, demonstrates that women often have to give up their employment. What is the long-term consequence of that for those women, and what are the long-term costs for us as a society if those women have to withdraw from the labour force to provide that kind of care? What kind of strategies can we develop so that it is actually a choice? We know that caregiving can be a very rewarding experience; but we also know that it is most likely to be rewarding if you actively choose to do that and if you have the kind of support to do that.

It is important to remember that there is an enormous range in the kinds of caregiving that are required. Some unpaid caregiving is temporary; some of it is very long-term, but not very complex. Some of it is both long-term and complex. Different kinds of supports and different kinds of alternatives are required.

We also have to recognize, in the caregiving issue, that many people do not have good households. We have done this literature on abuse in households, for instance, and we have done very little connecting that to the question of sending care home.

There is an awful lot of work to be done. I do not think we have very many good models. We have some suggestions, but we really need further research. I hope that answers your question.

Senator Cordy: It reminds me there is a tremendous amount of work to be done in that area.

Senator Morin: The men on the committee are also supporters of the centres of excellence.

Dr. Armstrong: Some of my best friends are men.

Senator Morin: I could say the same thing.

I would like to address my question to Dr. Worton. Dr. Worton is very modest. He is a world-renowned researcher. One of his seminal discoveries is the gene for muscular dystrophy. Doctor, would you briefly describe the disease and your discovery, and where this could lead us in the future in diagnostics and treatment? I think that would help the committee.

The Chairman: I will tell you the question I was going to ask you. It is a natural consequence of that. Has any one done any rough numbers as to what the implications are for the cost of the health care system as these new techniques like the one that Senator Morin described come into effect? We have these wonderful new treatments, but they will blow the cost of the system entirely out of the water? I know there will not be a definitive number, but if you could finish up with the cost implications, that would be helpful.

Dr. Worton: I was going to say that if I had planted a question myself, I would have planted the one you have asked.

There is a whole range of neuromuscular disorders that go under the classification of muscular dystrophy. Fourteen of them specifically have the name muscular dystrophy. As little as 15 years ago, we did not know what caused any of them. We knew they were genetic in nature, and we knew that many of them were inherited and that the inheritance patterns were different in different diseases. That is all we knew. There had been decades of research looking at the muscle using pathological techniques and so on. We had all kinds of hints, but no one knew what caused any of these muscular dystrophies.

By and large, the most serious muscular dystrophies start early in childhood, usually around age three or four, when the children have difficulty walking, climbing stairs, riding a tricycle, keeping up with their peers on the street. By the age of six, they are usually unable to get up from a sitting position on the floor. They are usually into leg braces. By the age of nine, they are into a wheelchair. By the age of 15 or 16, they have difficulty breathing because the lung muscles are gone. By the age of 18, they usually go on a respirator. If they do not go on a respirator, they die by age 20. Those who do go on a respirator are living and existing in a wheelchair with a machine breathing for them and someone feeding them and lifting them in and out of the chair. I know several of them personally who are in their 20s, and they live like this.

There are milder forms that attack a little bit later in life and have a slower course and end up with people who do not go into a wheelchair until quite late in life.

We tackled the most severe of these forms, the one called Duchenne muscular dystrophy, because we had a unique patient that gave us a clue as to where the gene might be on the chromosomes. We, in effect, isolated that part of the chromosome. We searched around and found a gene that was there. It took us five years to do that; another two years to prove that it was actually the gene that was defective in muscular dystrophy. We then discovered the protein made by that gene and showed that it was missing in the kids who have muscular dystrophy. That was a big discovery.

One of the things I like to point out is that that changed research all around the world on that whole spectrum of disorders, because all the research that had been done was going up the wrong creek, or down the blind alley, if you like, stopped. Everyone said this is the path we have to follow. Whatever the research cost after that, it was far more effective because it was on the right path.

That led to a fair bit of research in both Japan and the United States, and the person in the United States who did this research was Kevin Campbell, who actually trained in Canada even though he is an American. Kevin showed that the protein that is defective in these kids is part of a protein complex that has seven different proteins in it. He isolated each one of the proteins, painstakingly one at a time, and identified which genes were responsible for making each protein. Then he made the logical leap to say that those proteins, because they are part of this complex, might be the ones that are missing in other forms of muscular dystrophy, because the complex is necessary.

He went into an international collaboration and showed that six different forms of muscular dystrophy are due to mutations in six different genes that make these six different proteins that form part of the complex. Now we know the cause of six different forms of muscular dystrophy out of 14. We are making rapid progress.

Gene therapy has been tried in some of these disorders, mostly in mouse models. All of these disorders now have animal models. It is easy; it only takes three months instead of three years to create a mouse that has a genetic defect exactly like the one in the human, and then you can use that as a test system to test out your therapies. Gene therapy has worked in mice with muscular dystrophies that are absolute genuine mimics of the human diseases.

Gene therapy has not yet been tried in humans. I do not think anybody is quite ready to try gene therapy in humans for these disorders because the animal experiments are promising but they are not total cures. We are a little afraid of some of the consequences. In animals, you do not have to worry about using cells from one person and putting them into another. You can use inbred strains of mice so they are all identical and there are no rejection problems. In humans, you would have to use cells from another person, from a father usually.

The other thing about muscular dystrophy is you may not be able to replace the genes per se because you would have to get so many into every part of every muscle, but you might be able to rebuild muscle with stem cells.

We tried a cell therapy experiment back in 1990. It was not really my work. It was George Karpati at the Montreal Neurological Institute. I provided some of the laboratory examinations of the tissues from the kids that received cells.

We put what we thought at the time were stem cells into six young boys, all about age 6 or 7. In every case, the cells came from their fathers but the tissue matches were not that great. It was a very small experiment. We did 100 injections into one bicep. The results were very disappointing. There was no increase in muscle strength, no reconstruction of the tissue, and the protein that was missing was still missing.

We think we know how to do it better now. I have a dream: we can start with a six-year-old child or a four-year-old child who has this disease. We cannot take stem cells from his own muscles because they are pretty well worn out from regenerating his muscle over the previous five years. We may be able to take stem cells from his bone marrow, which would not be worn out because there is nothing wrong with the bone marrow or the blood. So, we would take a biopsy of his bone marrow and grow those stem cells in culture. We would then treat them genetically to correct the defective dystrophin gene, and then treat them so that they would change from being bone marrow stem cells to being muscle stem cells. Finally, if we could do this and then put those stem cells into the muscle, we may have a cure because the cells would be from the child himself. There would be no rejection problem.

That is our goal. We have funding from CFI to build a centre for stem cell and gene therapy, $4.4 million. The province matched that amount and we received $2 million from the hospital. We will be building an $11-million facility. We heard, this winter, that we will receive a $21 million grant, with one-third coming from the provincial government, to hire ten scientists to work in that centre.

That, coupled with the stem cell network we have just created, suggests to me that in a few years, I can come back and tell you that Canada is a leader in stem cell therapy, not only in muscular dystrophy, but in a whole broad range of disorders.

Perhaps I have answered your question on cost?

The Chairman: Moving into something as grubby as money after that discussion is very difficult to do. If there is any documentation on cost implications down the road, that would be helpful.

Dr. Armstrong, I want to be absolutely sure I understand you and I raise this with some trepidation. In your list of privatizing consequences, you use the word "privatizing" to mean "transferring the cost from the public sector to the individual." Is that correct? That is what you mean by privatizing?

Dr. Armstrong: We mean a number of things by "privatizing." That is one form. We are saying that privatization takes a variety of forms. We are describing, in privatization, a transfer from the public to the private or the individual. It could be a transfer of cost or work, which is a different issue from cost.

The transfer of cost could mean buying your own drugs or paying for your own home care. A transfer of work means sending home, from a hospital or an institution, a patient who still needs care. It could also be a transfer from provision in a public institution to a for-profit institution.

The Chairman: Why do you care about that if it makes no difference to the individual?

Dr. Armstrong: Because it makes a big difference for the women who provide the work in those institutions.

The Chairman: Up until then, I understood. I understand, if there is more cost to the patient. When you move to the difference between a publicly owned institution and a privately owned one, my instinct is that we have moved to an area of political ideology. You can make that statement, but it does not fall in the same category as all your other statements.

Dr. Armstrong: I do not think it is a political ideology. We have research in long-term care showing the difference between non-profit and public.

The Chairman: It makes a difference to whom?

Dr. Armstrong: To the people who provide the care, 80 per cent of whom are women.

The Chairman: How does it make a difference?

Dr. Armstrong: The work is organized differently. It makes a difference in workloads, in injury rates, in how hard they must work, what kind of support is present in the workplace, and in the kind of wages they earn.

The Chairman: I would like to see that evidence for this reason. You use the word "privatization" to mean several different things. It is important for this committee to understand your usage. When we begin to discuss situations where the individual is held harmless - that is to say they face no higher cost - then we must understand the different relationship between the public sector and the private sector.

On the other side of the coin, the private sector may be substantially more efficient. I am thinking in terms of the cost of the system. One may conclude that improved productivity is not necessarily bad. The evidence you have on the difference between the actual deliverers, assuming no more cost to the patient, would be really helpful to us.

Senator Morin: When we talk about private organizations, do we mean for-profit or not-for-profit?

The Chairman: I took your comment to mean for-profit.

Senator Morin: That is completely different.

Dr. Armstrong: We are talking about privatization in a variety of different forms, one of which is the transfer to for-profit. One is the transfer to community-based not-for-profit, volunteer-run agencies, which could make a big difference to women in terms of the amount of work that is expected from volunteer care labour - most of which is also done by women.

Our point - and our research is starting to show this - is that there are consequences for women. We must recognize, more than four of every five paid caregivers are women. Almost all cost in long-term care is for labour. Is the "efficiency" that you are describing then based on getting people to work a lot harder, in ways that undermine their health? We know that health care has the highest injury rate of any industry. Those injury rates tend to be higher in for-profit than in not-for-profit organizations. That is a problem. At least it ought to be a question that is raised.

Senator Morin: So it is not private. It is for-profit. That is a big difference.

Dr. Armstrong: Of course, and we make that distinction.

We have nine reports. We have a scan from Newfoundland, one almost completed in the Maritimes, one from Quebec, one from Ontario, one from Manitoba and Saskatchewan, one from Alberta and one from B.C.

Each of those draws out the research done in those regions on the whole range of forms of privatization. They include not just the ones that you were saying are widely recognized as privatization, but they also look at the research that compares service in large public institutions and small community organizations. What do we know about those? This, at least, should be a question.

Senator Morin: Has that research been published? Are these results available?

Dr. Armstrong: We have copies of all but the maritime report that we can easily send to you.

The Chairman: That would be helpful, thank you very much. I suspect this debate will come back to us again.

Dr. Worton: One last point. There is an economic analysis of genetic testing by a researcher in Toronto. I can either get copies of the material from her and forward it to you, or if I phone her, she would be on a plane in an hour to come here.

The Chairman: Is the material highly technical, or is it understandable to lay people like us?

Dr. Worton: I think it is understandable.

The Chairman: Thank you for your presentation.

The committee adjourned.

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