37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Monday, February 3, 2003

CANADA

 

Standing Committee on Health

EVIDENCE

Monday, February 3, 2003

[Recorded by Electronic Apparatus]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good afternoon, ladies and gentlemen.

    It is my pleasure to call to order what is really the first business meeting of the new year, and to welcome on your behalf representatives from the Society for Diabetic Rights, the University of Ottawa, and the Department of Health.

    This meeting was called in response to a series of communications we have received from the Society for Diabetic Rights, and from individuals across the country who are concerned about various things around synthetic versus natural insulin. We hope you will explain to us not just a series of symptoms, but rather what you think has gone wrong with the system for addressing your particular illness of diabetes.

    I call upon Colleen Fuller and then Brenda Johnson.

    Ms. Fuller.

    Ms. Colleen Fuller (President, Society for Diabetic Rights): Thank you.

    How much time do we have for our presentation?

    The Chair: Usually the society would have 10 minutes. How you divide that is up to you.

    Ms. Colleen Fuller: Okay. I will make the initial presentation, and I'm assuming there will be questions and answers during the next little while. Both of us will respond to the questions. Is this okay?

    The Chair: That's fine.

    I would suggest that you don't go on and on about your association. Some people tend to do that, indicating how many members they have, and all that. What we want to know is what you want from us.

    Thank you.

    Ms. Colleen Fuller: All right.

    My name is Colleen Fuller, and I am from Vancouver, B.C. I'm the president of the Society for Diabetic Rights. I know you are all aware of our organization.

    I want to thank the committee for taking the time and allowing us to make this presentation today.

    We have about 250 to 300 members across the country, and we have been working on this. We're not experts. We're all people with diabetes and families of children with diabetes, and so on.

    We're asking the standing committee to hold full public hearings on the question of the experiences Canadians have had with synthetic insulin. There are some specific questions. While I know you've all received the correspondence we sent to you, these are the specific questions we're hoping the committee will be able to address, and the kind of recommendations that it might be able to make to Health Canada about how to proceed on this.

    One question is that there is no real understanding either of what the experiences are, or how many Canadians are having experiences with synthetic insulin. There have been a growing number of adverse drug reactions reported to Health Canada, especially over the last year or two. There have been about 630 or 635 adverse drug reactions.

    We have obviously also received reports from across the country. There is consistency in the types of reports we are receiving. There is also consistency between Canada and other jurisdictions around the world in terms of the types of problems people are reporting. But in Canada, we don't really know what the situation is. We feel there's a weakness in post-market surveillance of adverse drug reactions in Canada. I know this is not just a problem with insulin, but a problem across the board; but we're addressing just insulin.

    The estimates of adverse drug reactions related to this insulin range from roughly 1% to 3%. A lot of Canadian doctors estimate 1% to 3% of Canadian diabetics have had adverse drug experiences with synthetic insulin. In the United Kingdom, Diabetes UK, which is the diabetes organization there, estimates that approximately 20% of diabetics have problems controlling their diabetes with synthetic insulin.

We just received correspondence between the Swiss government and the World Health Organization estimating that approximately 10% of diabetics have problems with synthetic insulin. The Swiss government has asked the World Health Organization to address the question of the availability of pork insulin, so there are also problems in that country.

    Some studies in Europe estimate the number of people having problems controlling their diabetes with this insulin is as high as 53%. In the United States, the Food and Drug Administration says that Humulin insulin, manufactured by Eli Lilly, is the eighth-most reported drug for adverse drug reactions.

    This suggests that not enough attention has been paid to what the problems are and the experiences Canadians have had. It's a very wide range; from roughly 3% to 53% is really what the situation is.

    We would like the standing committee to take a closer look at this, if it's appropriate in your view—and of course it is in our view—to recommend to Health Canada that they step up their program of post-market surveillance with synthetic insulin.

    We would also like to see the product monographs better scrutinized. We think there are some problems with the product monographs. We have not had access to all the product monographs, but have obtained some of them through the freedom of information avenue.

    One of the issues addressed by a Cochrane review, which I'm not sure I referred to in the correspondence with you, was the question of antibodies. I was interested in their view, which was that the claims of the manufacturers regarding antibodies formed in response to synthetic insulin were based more on the promotion of the product than sound evidence.

    I was interested; looking through our material, I found that in November 1987, when Novo Nordisk applied for approval of their insulin, the reviewer of the evidence submitted by Novo Nordisk said:

 

My concern that this approach

--of the company in the product monograph--

 

to making available the information/conclusion “that switching from Connaught/Novo beef/pork insulins to Novolin human insulins results in a significant decrease in insulin antibody levels after the transfer” could be considered as advertising....

    These concerns were also expressed by the people who were involved in this question way back then. They were concerned about whether the way the companies were addressing and giving information about antibodies was accurate, or whether it was promotional.

    We think there should be some reviews of the product monographs for that reason, and also for other related reasons, which I can address later.

    We would like to know what steps Health Canada has taken to increase public awareness and awareness in the medical community amongst diabetes educators, and amongst diabetics themselves, about the option of using pork insulin as a viable treatment option for those diabetics who are experiencing adverse reactions to synthetic insulin. I'm sure I don't need to go into any detail with the committee about the really high level of ignorance in Canada about the availability of pork insulin. This has caused a lot of harm to people who are not aware of the fact they would be able to simply switch insulin, rather than having to endure these terrible experiences they're having.

    We also have some concerns about the problems people have reported accessing insulin through the special access program. We think it's something that can be addressed, hopefully in a public hearing.

    The real thing we want in Canada right now is a national strategy to ensure that animal insulin is going to be available, not only now but also in the future. We mean beef and pork insulin, which is a type of insulin that a good number of people must have. It is not a question of a market choice. It isn't a question of choosing between one insulin and another insulin; it's a question of using an insulin that will support a good quality of life and that will not threaten your life, either by undermining your health or actually putting your life at risk.

    We thank the committee for enabling us to make this presentation. I do have a written presentation, but unfortunately, as we weren't able to submit it in time to get it translated, I have only English copies. I'm more than happy to make this available to the committee members. We're also available to answer questions.

    Thank you very much.

    The Chair: Thank you, Ms. Fuller.

    Unfortunately, we can't distribute English-only copies. However, the clerk will come and get them and he'll have them translated and then distributed.

    Ms. Johnson.

    Ms. Brenda Johnson (Vice-President, Society for Diabetic Rights): Actually, rather than do a particular formal presentation, my intention was just to answer any questions that people might have.

    The Chair: That's fine. Thank you.

    Next, from the University of Ottawa, Jan Braaten.

    Mr. Braaten, you have the floor.

    Dr. Jan T. Braaten (Endocrinologist and Associate Professor, Department of Medicine, University of Ottawa): Thank you.

    My role will be to discuss the different insulins over time and the new insulin analogues, or so-called synthetic insulins. I perhaps should use the word “analogues” here, since beef insulin and pork insulin are in that group of insulin analogues. Still, at this time they would be in the same group as the synthetic insulins.

    As everybody knows, insulin was discovered in 1921 by Banting and Best. Over the next 50 years we had only animal insulin, used in different combinations. We had protamine zinc, we had lente, and we had NPH later on--all long-acting insulins--but we have to realize that for the first 50 years we had only animal insulin, and for the first 30 or 40 years only the quick-acting insulin. The people who had insulin during these years are still alive, and many of them, even after 50-plus years, are still doing very well. So it's not that the animal insulin was bad insulin. The problem was that beef insulin, with three building blocks different from human insulin, had a tendency to create more antibodies. It therefore was more long-acting, but there were some problems from the creation of antibodies reacting against the insulin.

    Pork insulin has only one building block that is different from human insulin, and the action is almost identical. So switching from pork insulin to human insulin had small consequences, but shifting from beef insulin to human insulin had major consequences for some patients.

    I can give you a specific example. I had one patient who was on the beef-pork mixture. In North America it's mostly beef, because North America has more cattle than pigs, and in Europe there are more pigs, so they have more porcine insulin. But that's beside the point.

    Now, this patient--it's not a secret, it's been published in newspapers--came to hospital and was treated for ketoacidosis, and given human insulin. She had two cardiac arrests because of the rapid drop in glucose, and refused absolutely to go back to human insulin. She is the only one I know who is importing beef insulin from Britain at this time. She is quite happy using that beef insulin, and it is well controlled. She has some complications, but that is beside the point.

    In 1980 we got human insulin. The way it worked was that the gene for human insulin was discovered. It was implanted or transferred into bacteria first and then into yeast, and then the gene was inside either the bacteria or the yeast--more simply, it would cultivate this bacteria first, and then later on go into yeast--and each yeast could produce human insulin. So now insulin is produced in huge tanks, like beer yeast, and they have as much human insulin as they want from the human gene.

    This is not what they call synthetic insulin. This is basically human insulin. It is the same as we have in our body, exactly the same composition, with no difference, no antibody formation.

    We believed this insulin would be the ideal insulin. Unfortunately, it didn't work out like that. Some people didn't like the human insulin. It didn't inject well, and it had some complications. Some wanted the beef-pork insulin back again. However, both the Lilly Company lately, and Novo Nordisk before that, discontinued animal insulin because of low sales and the complication of getting all these animal pancreas, extracting insulin, and so on. It's much easier to just cultivate insulin in a big tank, obviously with yeast, and to get insulin that way.

    So that was the human insulin that took over, and which had almost the same effect as pork insulin. But a few people have noticed some differences between pork and human insulin. Of the people who were on beef insulin and were switched to human insulin, many got into trouble. What happened was that the human insulin reacted much faster, and there was no antibody development that could dampen down the effect. The result was that people who were previously very well controlled with one insulin injection a day, using beef-pork, or beef insulin—mostly because beef composes about 80% of the North American beef-pork insulin—got into trouble with irregular glucose control with low blood sugar. They needed to use two, three, or maybe four injections a day, and were still not being able to get the same control of their diabetes as before.

    I have seen this repeatedly. I have been here for so many years now, and have had a number of patients who have been through all of these developments. I've followed them consistently over time. There is no question that a lot people who were well controlled in the past, long-term diabetic individuals, got into some problems with regulation and had to switch to human insulin because of the rapid action and irregular control.

    This is not always appreciated by practitioners or doctors who see very few patients with diabetes. You have to see many people with these problems over many years before you actually really believe that it happens. I can tell you this is a real picture, no question about it.

    The next step that came into the picture, and I don't know exactly why it happened, was that we got the insulin analogues. In these synthetic insulins, they replace one of the building blocks in the human insulin molecule with another block, or amino acid. Insulin has 51 amino acids or building blocks. One of these amino acids is replaced with a different one, giving a different action. The molecule changes shape, changes adhesion to the receptors, and has a small different effect.

    The first one, unfortunately, created some tumours in rat livers. So it had to be discontinued. The two that are now on the market—one from the Eli Lilly company and one from Novo Nordisk—have not been shown to be of any danger as far as tumour development is concerned.

    A specific thing with these two synthetic analogues, called Lispro or Humalog, and Aspart or NovoRapid, is that they have a very short action. It's actually about five hours, when the normal or regular insulin is about eight to ten hours. But this is with the same number of molecules of insulin. So it means that someone taking ten units of the rapid insulin, acting in five hours, compared to someone taking normal insulin, acting over ten hours, is obviously getting much more intense action on their glucose level. This has led to the problem with the new insulins. People have been getting low blood sugar, or hypoglycemia, quickly.

    This problem is not as prominent in early diabetic cases, let's say in the first 10 years, and maybe up to 15 years, when you still have some regulatory mechanism in the body. But in long-term diabetes of 20, 30, or 40 years' duration, which I see quite often, these people have lost the regulatory mechanism to really fight hypoglycemia. Stress hormones that defend people against low blood sugar are minimized in action, and all kinds of normal regulatory mechanisms have been disrupted by long-term diabetes. The problem these people have is the rapid drop in blood glucose. This is not stressed very much because few doctors have a chance to see many of these people. People with long-term diabetes are not that frequent. The main problem with this new insulin has been the rapid drop in blood glucose.

    What is said about this new insulin is it is a meal-related insulin. Give the insulin before the meal and it acts for five hours; therefore, it takes care of the whole meal peak. That is obviously true, but if you use ordinary, regular insulin and you give it half an hour before, you get almost the same effect. So it's not an absolute requirement that you use this new insulin as a meal-related insulin. Then, you also have to use it three to four times a day. If you do that, you would expect to get perfect control. You can control the meal-related hypoglycemia, the elevated glucose level, and everything should be perfect when it comes to control.

    It has been shown that the overall glucose control with these new insulins has not necessarily been better than with the old insulins. The hemoglobin A₁C, which represents the overall control, has not changed. It doesn't mean it doesn't change in some studies, depending on how you do the study and what your objective is, but in the practical setting over several years they could not say these new insulins are better than the old insulins, because the control level was basically the same. The reason is, when you use this quick-acting insulin only, you get certain time intervals where you get a higher glucose level—there is no insulin available. But when you use the older insulins, or the “manual” insulin, you have better continuous coverage of the glucose level.

    So it is not as simple as just talking about meal-related insulin. It is ideal for meals, but it is a little bit more complicated than that, because 24-hour control is what we need, and there are many times when there is a long time between meals and you need some long-acting insulin.

    Now a new insulin analogue, or synthetic insulin, is coming on the market in Canada. It is used in the U.S. It is more or less stable for 24 hours or more. It is seemingly simply totally stable, something like the protamine zinc insulin in the past, which was an animal insulin. It's called “glargine”— that name is probably difficult to remember—and it again involves more changes in the human insulin molecule. This insulin is seemingly pretty good, but we don't have experience with it, so we cannot say. Then, there are a number of other experiments going on now with all kinds of changes in the insulin molecule, so you're going to get a whole series of insulins—and I don't think we need them, but that's a different matter; that's very subjective.

    Treating diabetes has to be individualized. We have people who need fewer than 20 units a day—even half a unit at a time—and other people who need 60, 70, 100 units a day and are quite stable. Individual variations between people are so enormous that we can not make any statement about any insulin that is absolutely universal. All have to be treated as individuals and looked at in terms of how they are built, because everyone has a different development of complications, a different reaction to insulin, a different diurnal rhythm, and they react differently to all the hormones other than insulin. There are so many differences that we can not make an actual statement that, “This is right and that is wrong.” We have problems with the old insulins and we have problems with the new insulins. Unfortunately, it is not that simple.

    I think I'd better be open for some questions, if there are any questions.

    The Chair: Thank you very much.

    We'll move now to the Department of Health and hear from Julia Hill, who perhaps can explain how Health Canada has been following this story and reacting to the—I forget whether it was 300 or 600—adverse reports you've received in the last year about patients who are having adverse reactions to the synthetic or human insulin.

    Ms. Julia Hill (Acting Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health): I'd be very pleased to address that. I'd also like to indicate to the committee that we have been very appreciative of the constructive approach the society has taken in their interactions with the department. It's been a very good experience for us in terms of sensitization as well.

    The bottom line—our first statement—is that there very clearly are Canadians who need animal-sourced insulins to manage their diabetes. We have no doubt about that at all.

    We acknowledge that it's a matter of concern. The current science knowledge does not really enable us to understand why the synthetic insulins or the human insulins do not work as well for some people as do the animal insulins, but clearly that is the case, and these are real people expressing real problems. So we do take that theory seriously.

    Both the human and the animal insulins meet the safety requirements. When both types underwent evaluation, they met the safety needs. And clearly there are a huge number of Canadians who use the synthetic or human insulin very safely, but we do have a concern for those who need the animal-sourced. The available data that we have for adverse drug reactions are actually comparable for both types. Remembering that there is a much higher number of people taking the human insulin, there is a much higher number of adverse drug reactions. But when we do a comparison, there is nothing to indicate to us that there are greater problems with one than the other.

    The bottom line is that diabetes is a very serious, life-threatening condition. This again underlines that each patient needs the choice of the product that responds to their individual needs.

    We understand the concern of the Society for Diabetic Rights about access to animal-sourced insulin. Clearly there were business decisions taken by companies, in the mid- to late nineties, that withdrew from the market beef insulin as well as beef-pork insulin. That was not a Health Canada withdrawal of a licence; that was a business decision of the company. We are left with one licensed company, Eli Lilly, which does still provide pork insulin in Canada. The ideal situation would be not to have a monopoly. The ideal situation would be to have another company that made that product available; that would be much more reassuring for everybody.

    This leads to questions with respect to the role of Health Canada. The law of the land is that government cannot oblige the private sector to market a product; that is the context within which we are working. It applies to pharmaceuticals. Health Canada is responsible for ensuring that products that are marketed meet safety standards.

    But those two comments are not very reassuring to people who need animal-sourced insulin. So recognizing that we can't force a company to market, and we can't impede a company that wishes to cease producing something, what can we do? Well, we have been working on that. We're getting part way, but certainly this discussion will be very helpful, and ideas from other parts of the community are very welcome. We don't see an easy fix to this. We have done a couple of things. We need to do more. We have issued a first “It's Your Health”, which addressed some of the initial concerns that were expressed to us about the safety of the human insulin. We are working on a new edition, because we need to provide more information about animal insulins and about the existing availability of animal insulins. That is something that's in the works right now.

    We're continuing to verify that the existing supplier of pork insulin intends to continue to supply that insulin. The latest communication we had from Eli Lilly was on January 29. It said, “At this time, Lilly has no plans to discontinue Iletin II purified pork insulin.” The words “at this time” do not provide any of us with as much assurance as we would wish. Again, strictly speaking there is not much Health Canada can do to force the company to say any more than that.

    We have researched other sources of animal-sourced insulin. We are aware of one in the U.K., which was referred to by our learned colleague earlier, and there is access through the special access program to that product. We're aware of another one in France and one in Asia. None of these companies has sought marketing authority in Canada. Consequently none of these products can be or has been assessed by Health Canada. We need to receive the information from the company and the request.

    Currently, access to beef-pork insulin and the beef insulin is possible through our special access program. It enables physicians and patients to access products that are not licensed for marketing in Canada. It's not an ideal situation, and we recognize that. There are issues. It's not an assessed product. We can't really talk about the safety and efficacy of the products that are released through the special access program; again, the company has not asked for...and has not submitted its information.

    The process represents an additional step for people who already have an added level of complexity in managing their lives. And we are aware of the cost issues, which we hope will be addressed through FPT discussions that are ongoing.

    However, given that the companies in question have not sought approval, the only way we can enable access for these patients is through our existing special access program. As recently as last fall, we had a discussion with the CP Pharmaceuticals Company in the U.K., which is the current provider of the majority of the pork and beef insulin coming into Canada. We talked to them about requirements for submission. We talked about ways in which we would facilitate—within the boundaries, of course, of our regulatory obligations. But what could we do to encourage them? They had spoken to us five years ago about coming forward with a submission. They had not. What could we do to encourage them to do so?

    I know through exchanges with Ms. Johnson from the society that there were also discussions there, and we have explained how the process works. Again, we are very willing to facilitate, but to date there has been no submission coming forward.

    So we remain very much committed to facilitating any kind of application, to talking to the companies, to making ourselves available. We very much want to work with both the society and any other parts of the health partnership in Canada to try to find a solution to this. We will update the “It's Your Health” and ensure that there is a broadcast that is quite wide. We will consult before we issue the final document to ensure that we can address as much as possible the concerns of the society and others, because there are others with whom we interact on these issues. We remain very open to questions.

    I have brought with me for your information three technical experts—I'm not a technical expert—Dr. Supriya Sharma, who is a physician involved in the post-market surveillance elements of the program; Dr. Harold Rode, who is a PhD scientist with tremendous knowledge of the subject; and Mr. Ian MacKay, who is the manager of our special access program. We would welcome questions and discussion.

    The Chair: Thank you very much, although I'm not sure if understanding the science any better is going to help us, when it sounds to me that it's more the market and economics.

    We'll begin the questioning with Mr. Merrifield.

    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): I want to thank you for coming in. It indeed is an important issue and an important discussion.

    I've had the diabetic association in my office discussing this issue a couple of times—at least once them, and others I've talked to on the phone—and I've had letters written to me. This issue did concern me over the last year as I became a little more aware of the plight of the diabetics who were on the animal insulin and were fearful of not being able to continue to obtain it.

    I have a number of questions. First of all, does it boil down to just economics by the pharmaceutical companies, or is there something else? Is the mark-up more on the human insulin? Is there more profit in providing that insulin compared with the animal insulin? Those questions certainly arise.

    Because I was quite aware of it, I sent a letter to the minister concerning her awareness. This letter came in actually last Friday, in response. Maybe somebody on the panel wrote the letter—I'm not sure—but she signed it, anyway.

    I think the issue is whether we have a problem with awareness on the physicians' side of it. Are physicians knowledgeable enough, or prescribing the appropriate insulin, and do they sense, or do they see the animal insulin as a sort of generation-old treatment? Is that part of the dilemma that you're sensing?

    I don't know who would want to tackle that question; I'm just trying to get a handle on the problem.

    Ms. Brenda Johnson: Well, on your first question about the economics involved, there's no doubt in our minds that synthetic insulin is definitely cheaper to produce. Pharmaceutical companies have always stated that it was a business decision as their reason for removing the animal insulins.

    It's also interesting to note that over the last few years especially, doctors, hospitals, nurses, practitioners, and pharmacists are not even aware that pork insulin still exists. As a matter of fact, it's been a very interesting process to go through to realize how many people are not even aware there is an alternative here. We have been told time and time again that synthetic insulin is better for you, that synthetic insulin is cheaper, that you'll never run out of the supply of it, etc. The availability of even the pork insulin has been such a well-guarded secret, it's absolutely incredible.

    So, yes, in answer to your question, it's obviously very business related.

    Mr. Rob Merrifield: If there was more demand for it, would that not drive the price down on it?

    Ms. Brenda Johnson: If you looked at the profits going up as the availability of various insulins went down, it was very simple to see what the end result was. They first took off the most widely used and popular insulin, being the beef-pork mix. That was the first to go and that was when Novo Nordisk took off their animal insulins in 1995, which left one pharmaceutical company making animal insulins and providing them in Canada. So they had the monopoly, obviously, on that too. As the other insulins were taken away and these synthetics were basically given to you, regardless of whether you wanted them or not, the profits rose--

    Ms. Colleen Fuller: And the price rose. When synthetic insulin was introduced in Canada, the cost of a bottle of insulin averaged, I think, around $6.50 or $7. I might be off by 25¢ or 50¢ or so, but roughly that's what it was. In 1995, when Novo withdrew all of its animal insulins, beef-pork insulin cost about $10 or $11 a bottle. Now insulin costs roughly between $23 and $30 a bottle. There's not really a cost difference between animal and synthetic insulin. Animal insulin costs about $21, $22, $23 a bottle.

    When synthetic insulin was introduced, both companies argued that they would be able to reduce or minimize the cost of insulin to diabetics because it was so much cheaper to produce. On a per-unit basis, the cost of production went down quite significantly. Instead, what's happened is that the cost of insulin has increased astronomically.

    When I was diagnosed as a diabetic in 1968, it was $1.19 a bottle and it stayed at that price for quite a number of years. Then it started eventually to go up. So from my perspective, the cost of synthetic insulin has not had a positive impact on insulin prices. It has, however, had a very positive impact on the profit levels of the companies.

    Mr. Rob Merrifield: The special access program allows it to come from Europe or Great Britain to here, I understand. Is that correct, Julia?

    Ms. Julia Hill: Correct.

    Mr. Rob Merrifield: Is there a cost to the product because of that access program?

    Ms. Brenda Johnson: Oh, yes. Speaking from experience, I import beef insulin from the U.K. and my first shipment was $930. That's not covered by any insurance company and that will last me, hopefully, if I can stretch it out, because I've been mixing beef and pork insulin for that reason, for six months.

    Mr. Rob Merrifield: Is that the product or is that the program?

    Ms. Brenda Johnson: Well, that's the product plus the shipping, the handling, the import fees, the customs brokerage fees. I worked it out on a per-bottle basis and it was exactly $56.11 per bottle for that drug.

    Ms. Julia Hill: If I might just add to that, typically provincial formularies do not cover products that are acquired through the special access program. Typically, formularies will cover only products that have been licensed for marketing in Canada. There are some exceptions to that, but this is generally the rule.

    Ms. Brenda Johnson: I was told that the reason it was not covered by my private insurance company was that it did not have a drug identification number.

    Mr. Rob Merrifield: So that may be part of the problem of the awareness and the whole marketing, because the provincial formularies don't carry it. Is that what you're suggesting?

    Ms. Julia Hill: I was really just responding to the cost question. But if I might, I can just add two things to what's been said.

    We are aware that in regard to many products that are beef-sourced, companies are thinking very carefully about whether or not they continue providing them, because of the concerns about TSE-BSE. So that may be one factor.

    The other thing I forgot to mention is with respect to sensitizing doctors. We will be offering to work with the Canadian Medical Association on their guidelines for diabetes so that there is more discussion about the choice of products available for patients.

    Mr. Rob Merrifield: I have one final question. This new product that we talked about, Mr. Braaten--

    Dr. Jan Braaten: That's going to come on the market?

    Mr. Rob Merrifield: Yes. Would that solve any of the problems we're looking at here? Would it act the same way as the animal insulin? You're saying it's going to stretch over a 24-hour period--or do we not know that yet?

    Dr. Jan Braaten: From the literature and the information we have from the U.S., it is long acting and will work something like the old animal insulin, the beef protamine zinc insulin, with stability over 24 hours. As to whether that is the real, practical situation, we don't know for sure yet.

    If we really need it, that is another question, but it may replace the beef insulin, possibly.

    Mr. Rob Merrifield: How far from the market is it, and what are the costs?

    Dr. Jan Braaten: It has been in the U.S. for at least for a year now, and I have patients going over the border to pick it up. But that is a different matter.

    Mr. Rob Merrifield: So it's not approved in Canada. Is that what you're saying?

    Dr. Jan Braaten: Not yet.

    Mr. Rob Merrifield: Oh, the patent applications.

    Ms. Julia Hill: I beg your pardon, but it has been approved in Canada; that was just confirmed. They just have not decided to market it yet.

    Mr. Rob Merrifield: Who hasn't decided?

    Ms. Julia Hill: The company.

    Mr. Rob Merrifield: Thank you.

    The Chair: Madame Thibeault.

[Translation]

    Ms. Yolande Thibeault (Saint-Lambert, Lib.): Thank you, Madam Chair.

    I need some clarification. I'm having trouble understanding the whole process involved in obtaining this drug abroad. There is the Special Access Program. Could you please explain to me how it works, step-by-step? I imagine that the first step is to see one's doctor, but what happens after that? Who is eligible for this program? How does one become eligible for it?

    Second, I would like to know whether individuals can decide to write to a company in England or France, for example, and ask for a certain amount of the drug, without going through the Special Access Program.

    Ms. Julia Hill: There are two questions here. I may perhaps refer your question to my colleague, Mr. MacKay, if I am mistaken.

    After discussing the matter with the patient, the doctor decides that this is the drug for this patient. The doctor then sends us a request and a form. We look at the request and we reply within 24 hours. As explained earlier, the product is not assessed by Health Canada; we do not have any details about it. However, if we know that there are particular problems with the product in question, we discuss them with the doctor. However, it is up to the doctor and the patient to make this decision. Even if there is some risk involved, it is their decision. In other words, this is a medical practice. At that point, we confirm that authorization for shipping the product is granted. The doctor contacts the company directly, and they work out the details at that point.

    As to whether any individual could do this, there is legislation about importing products for personal use. So not just anyone can import products for personal use in whatever way he or she chooses.

    Ms. Yolande Thibeault: So people have to go through the program?

    Ms. Julia Hill: Yes.

    Ms. Yolande Thibeault: Thank you, that is all for the time being.

[English]

    The Chair: Ms. Wasylycia-Leis.

    Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you, Madam Chair.

    First of all, I wanted to thank Colleen and Brenda for their persistence over the last year. I think it was a little more than a year ago that you were on the Hill with a group of family members, people who had been directly impacted by the reactions to synthetic insulin, and you had family members who had lost loved ones and family members who had experienced significant disability as a result of the reactions to synthetic insulin. That had a tremendous impact on all of us.

    And here we are a year later. At that time we asked questions in the House and the minister then said the issues around supply were looked after and the issues around the monograph were looked after, and in fact the possibilities of adverse reactions were duly noted, and not to worry. That is clearly not the case.

    You wrote, then, to the minister in July, so that's seven months ago, and you wrote to Chris Turner six months ago. Have you received any answer to those questions you posed then? I noticed as of January 9 you had not received any response so I'm wondering if you have since then.

    I know we have officials today accounting for some of what has happened and clearly there's been some movement. There is an indication on the part of the department of their intention to recognize the problem and to work together with you, but I don't sense that you have received answers to your questions and we're here today to hear the witnesses and make recommendations.

    So on the three critical issues.... First, in regard to a reporting system for adverse reactions, is there one, or is it up to the work you do?

    Second, has there been any move on the part of the department--and I'd like both the society and the department officials to answer--with respect to the monograph and the fact that you believe there's misleading information, and it's based on the company itself and the information they generate and the problems that arise? What's happened with respect to that?

    And third, with respect to supply, most depressing or shocking of all today is the thought that Health Canada, which is the body that is supposed to redress problems from the marketplace, is supposed to protect patients in the face of the vagaries of the marketplace, is saying, we can't do anything, basically.

    I just can't accept that, and I can't understand it, because in fact the duties of the Health Protection Branch are outlined. The act is clear in terms of the protection of Canadians.

    If that logic were to apply generally, where would it end? Does it mean that for my son, who needs liquid valproic acid to stop seizures on a daily basis, I wouldn't have an option, even though it was a life and death situation, if a company decided not to produce that? We're dealing with life and death.

    Surely the government has the ability to lever some power vis-à-vis these companies, who are reliant upon our health care system, who are making exorbitant profits, and we can't tell them to provide product.

    I want to raise these questions. If the officials are saying they can't from their point of view, then we have a political challenge and an issue to raise with the minister and with the cabinet, because this is not acceptable.

    Sorry, I've gone on too long, but I hope you can answer some of those questions.

    Ms. Colleen Fuller First of all, we did write to the minister in July, and we raised our concerns about a number of issues that you've just raised. We haven't had a response back or an acknowledgment of our correspondence with her.

    In August, after the Cochrane review issued its report, which was a very important review of the existing evidence, we wrote to Dr. Turner and asked actually for this bulletin to be withdrawn based on the contradictory information that was in the Cochrane review. We haven't had a response from Dr. Turner.

    In November I contacted the minister's office and asked when we might expect a response from the minister, and I was told that it was a political issue and it was being discussed--or something; I can't remember exactly what the young woman told me. She said, keep insisting on getting a response and you will get a response. So that's what we've been doing. We wrote again in January.

    We feel that there are some people in Health Canada who are interested in addressing this in a more complete way. That's just a feeling we get. We don't know exactly who they are or anything. It's just that you get signals from different people and we think there is some interest in working on this and addressing some of the issues we've raised.

    We believe the adverse drug reaction reporting in Canada generally is not very good. We know that the ADRs that are filed with Health Canada represent anywhere between 1% and 10%. That's pathetic. That's a problem generally. It's a problem that is affecting us.

    We have people contacting us. When people contact us, we encourage them to contact Health Canada. I know that's why the reports to Health Canada have increased, because when we get contacted, all of the people--not all of them, I shouldn't say that--but a number of the people who have reported to Health Canada first contacted us. We encourage them to report if they believe there is a link between the problems they're having and the insulin they're taking. We don't say, only if you're taking synthetic insulin, or anything like that. We say, if you are having a problem and you link it to this, report it.

    We believe Health Canada should be encouraging people to report--encouraging them. Otherwise, how is Health Canada ever going to know what's going on? That's on the ADR reporting system.

    On the product monographs, we haven't seen all the product monographs. This is a problem. I know that Health Canada is in discussions right now about developing a way to facilitate public access to those monographs. I support that. I think it's important. Right now the product monographs that are guiding practitioners are in my view inadequate.

    I'm going to give you one quick example. In Alberta, there's a woman who is a member of our organization who has had horrible problems. In a study that I referred to in one of my letters it's referred to as “arthritis arthralgia myalgia” syndrome. It was documented by a fellow by the name of Galloway, who worked for Eli Lilly; I don't know if he was working for Eli Lilly when he did the study. They identified this as a syndrome that specifically was linked to rDNA and pro-insulin, two types of biosynthetic insulin. For all of the people who had this problem, when they stopped using the insulin the problem disappeared or was alleviated.

    Now we have a woman in Alberta who's reported this condition, and actually quite a number of people. They are being put on different types of drugs to address this problem they're having because there is no information about this syndrome in the product monograph or anywhere else. She is being told by physicians in Alberta that there is no immune response to synthetic insulin. This is just not the case.

    So instead of doctors or pharmacists being able to get the information on the monograph, they're not getting it. Why isn't the information there? That's why we have questions about the product monograph. We know that some of the problems are being reported and we've seen studies outlining the problem, but the doctors and the pharmacists don't know anything about it. So somewhere there's a missing link there.

    Regarding this supply issue, I don't accept either that the Department of Health can't do anything. And, by the way, there is so much wrong information in here, and I hope that people will refer to the letter that we wrote to Anne McLellan about this. We received information from the International Diabetes Federation that Eli Lilly has already disclosed internationally that they're no longer producing pork insulin.

    Eli Lilly informs us. They inform our members who contact them. They inform the doctors who inquire and they inform the Department of Health that they have no plans at this time to withdraw pork insulin from the market. There's something that is not being told to people in Canada. We have confirmation from the IDF that this was the information that was disclosed to them by the Eli Lilly representative in June 2001. So here we are, a year and a half later, and they still have not given us the same information that they're disclosing to their international...to whomever they are in the IDF.

    It is a political problem? Because what do we do?

    Connaught Laboratories produced animal insulin. It was a condition of their operation in Canada that they would do this. Novo provided this insulin through Connaught to the Canadian market and they had to meet certain conditions in order to do that, and so on.

    If the Department of Health can't compel a company to produce the insulin and we can't get the insulin that we need, then our lives are going to be threatened. A lot of us will die if we can't get pork insulin.

    If the Department of Health can't intervene in the market, they have a responsibility to produce the insulin themselves. That's my feeling about it.

    The Chair: Thank you, Ms. Wasylycia-Leis.

    Dr. Bennett, you have the floor.

    Ms. Carolyn Bennett (St. Paul's, Lib.): Thank you.

    I guess I'm having trouble in terms of efficacy. The Cochrane Collaboration study said it did not detect a significant difference in antibody formation between the human and porcine insulin. It said there was no substantial difference in hypoglycemic events and that market forces had dictated a change in policy.

    So I would glean from this that it was cheaper, it was just as good, so they kept going with it.

    I guess I need to know in terms of whether it's an arthralgic condition or one of those kinds of things that obviously you would like in the product monograph. At the same time, what was happening to people's hemoglobin A₁C, what was happening in terms of their hypoglycemic events, how do we know they may have to put up with a little joint trouble in order to get much better control, less retinopathy, less kidney problem?

    So if I were making my mind up, I'd rather have less retinopathy and less kidney problem and put up with a little joint problem. There's no question that the joint problem should, if there's a significant amount, show up in a product monograph so that people don't think it's something else.

    I'm still wondering, what actually is your solution if it's a market problem? What's the Canadian Diabetes Association's view of it? Could they go into business importing the stuff?

    When I was on the board of the Royal Lifesaving Society, there were life jackets we thought were better, so we started to import them and had a little revenue stream on the side.

    As a government, how can we make a company do something that is not a good business plan?And if it's so great, why doesn't the Canadian Diabetes Association do it? What actually is the solution that you're putting down on the table?

    Ms. Colleen Fuller First of all, I want to address some of your comments about the Cochrane review of the evidence. Almost all of the studies looked at the experiences that people had for a period of under six months when they transferred from animal insulin to synthetic insulin.

    There were no long-term randomized clinical trials looking at the impact of the insulin on diabetes complications, so we actually don't know if there's an improvement in diabetic retinopathy, kidney failure, cardiovascular problems, and so on. We simply do not know that. There's not enough evidence addressing those issues. In fact, there were no randomized clinical trials looking at that.

    There were no randomized clinical trials looking at the impact of the insulin on quality of life and there were no randomized clinical trials looking at mortality rates.

    So these are areas where we simply don't know what's going on. What we do know is that for the first six months of patients transferring from animal to synthetic insulin the experience with hypoglycemia was that there were no big differences between the two insulins. And that actually corresponds, as well, to a lot of the reports we have received. Some patients, myself being one of them, immediately reacted to the insulin. Within 24 hours I was in a coma, and a lot of people have experienced that. That was my experience. Most people began having the experiences that they reported after, I would say, between eight and sixteen months. That's probably a fair indication.

    Ms. Carolyn Bennett: So the study was just six months, but your experience is that it's people on it eight to twelve months?

    Ms. Colleen Fuller: The average length of time that a study was conducted on the transfer from one species of insulin to the human insulin was 5.8 months, according to Cochrane. So there's a lack of evidence, in my view, that gives us the kind of information we need. So that's that.

    The Canadian Diabetes Association believes animal insulin should be available on the market. In 1995, Novo withdrew all animal insulin from the market and at that time there were 45,000 people using animal insulin in Canada. Most of the people who were involved in this issue at that time--actually from 1983 on--advised really strongly against transferring people en masse, but that is exactly the experience in Canada.

    Canadian patients, 45,000 at a minimum, were transferred en masse to animal insulin, which is why you would see an increase in the number of problems that were being reported probably after that time.

    So the Canadian Diabetes Association was pushed by its members to address this crisis that was occurring. There were a number of people obviously who were having problems and reporting them to the CDA and there was a movement actually, located in Alberta, of people who began really hard campaigning to keep animal insulin on the market.

    The CDA's position is that animal insulin must continue to be available to Canadians. They recognize that there is a significant minority of people who continue to have problems with synthetic insulin, and that it is not only people who had transferred from animal to synthetic. We're also talking about children, pregnant women, and newly diagnosed diabetics, basically.

    Dr. Jan Braaten: I would just mention that definitely the transfer from animal insulin to human insulin created a lot of hypoglycemic episodes in patients who never had them before, but this was mainly, in my practice, the long-term diabetic patient, the one who had instability from before, and had diabetes for 20, 30, 40 years; they were really in big trouble. There's no question about it. I don't have any big statistics, but I've seen enough patients to know this, and this is also from other doctors who have been in practice for a long time and had the same experience. There is no question that we get more hypoglycemic episodes because of the reactive action and the dampening effect of antibodies and the animal insulin.

    Maybe some of the new insulins coming out are solving some of the problems. We cannot totally dissect that thought yet, but there is no question that we have a lot more hypoglycemic episodes with people who could be more controlled.

    Ms. Carolyn Bennett: As a clinician, why did you change people's use to human insulin?

    Dr. Jan Braaten: Because animal insulin went out of the market. It wasn't available any more.

    Ms. Carolyn Bennett: Do you believe most clinicians in this country began the switchover because of the availability problem?

    Dr. Jan Braaten: We simply couldn't get it. First the Canadian product went out and then Lilly stopped it because they tore down the factory. It was an old factory and they couldn't produce more. That was the argument.

    And that is not only a personal experience, but it is mostly in the long-term, difficult, diabetic situations where they had....

    Ms. Carolyn Bennett: But were there some patients who were better on the human insulin than on the previous animal insulins?

    Dr. Jan Braaten: I don't necessarily think so. But of course, some would prefer it in the specific early phase of diabetes. On the other hand, they might not have had the chance to see the difference. And then we have had the tremendous commercial pressure. This is a different matter.

    Ms. Julia Hill: Dr. Bennett, I wonder if I might ask Dr. Sharma to say a few words on the Cochrane report, and from a clinical perspective.

    Ms. Carolyn Bennett: Yes.

    Dr. Supriya Sharma (Director, Marketed Biologicals and Biotechnology Products Division, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health): First of all, I just wanted to say thank you to the Society for Diabetic Rights for reporting the review to us.

    I know the correspondence had initially gone to Dr. Robert Peterson of the Therapeutic Products Directorate. An e-mail response acknowledging receipt of it did go out. Another letter also went out last week under Dr. Chris Turner's signature. It was faxed, so it should be dated sometime from mid last week. That letter detailed the fact that we did take the study very seriously.

    One of the things we did is to contract an independent, non-profit, academic group that specializes in systematic reviews, and actually has expertise in the biologics area, to take a look at the Cochrane review.

    Just to answer the question in terms of outcome parameters, one of the conclusions of the Cochrane review, and the review of the review, was that not only were there not significant differences in terms of detection of hypoglycemic adverse events overall, but there also really wasn't a significant difference in some of the outcome parameters that Dr. Bennett referred to, which are the glycated hemoglobin levels. Some of these secondary outcomes they looked at were fasting glucose levels and insulin dose. So if you see an escalation in dose, it may be an indication that it might not be functioning in some patients as compared to others.

    So overall, in terms of the review, the two groups are really comparable. Again, this is within the limits of looking at randomized control trials and at broad-based studies. But when we bring these populations together, the two groups are quite comparable.

    As a result, with this new information, we will be looking at the insulin. We will be amending “It's Your Health” to make sure we accurately reflect what we've seen in that review.

    But overall, the two groups seem to be comparable in terms of hypoglycemic events, which seems to be the one that came up the most, and in terms of outcomes.

    The Chair: Thank you, Dr. Bennett.

    Welcome, Mr. Thompson.

    Mr. Greg Thompson (New Brunswick Southwest, PC): Thank you, Madam Chair.

    The Chair: We should roll our white stone out on the road; you're here.

    Mr. Greg Thompson: Thank you, thank you very much. Now that I know that you're chair of the committee, I'll be here on a regular basis.

    Some hon. members: Oh, oh!

    Mr. Greg Thompson: Madam Chair, I'm sure you're going to be generous in terms of time.

    But from our witnesses, Mrs. Johnson or Mrs. Fuller, I'd just like a quick answer to this one, so I can get on with the point I'm attempting to make.

    How many people in Canada have diabetes? How many sufferers do we have?

    Ms. Brenda Johnson: In total, type 1 and type 2?

    Mr. Greg Thompson: Yes, in total.

    Ms. Brenda Johnson: There are about 3 million.

    Mr. Greg Thompson: Okay, about 3 million. So we have 3 million sufferers, and I'm led to believe we have more people dying from diabetes, or the effects of diabetes, than AIDS for example. Is this correct?

    Ms. Brenda Johnson: I have no idea.

    Mr. Greg Thompson: Actually, this was in the bulletin that we've all discounted as not being entirely accurate. But I'm taking this from Health Canada—if we can believe what Health Canada puts out. I guess that we can from time to time, although we take exception to some of the points they put out today.

    At the tail end of this particular bulletin, which I think is dated July 2000, it says, “Diabetes and its Complications Kill More People Each Year than AIDS...Get Serious About Diabetes”. This is a pretty strong message.

    I guess the point I'm attempting to make is that in your letter to the Minister of Health—which I am glad you included in the notes before us today—and in your letter to the standing committee, you point out there have been over 550 reports of adverse drug reactions to human or synthetic insulin. Out of these, at least eight people have died. Is this correct? Are these numbers correct?

    Ms. Brenda Johnson The latest numbers are 633 adverse reactions and nine deaths.

    Mr. Greg Thompson: Nine deaths; that's a pretty powerful message, I think.

    What I guess upsets me in this...and it's so typical of government. I'm not pointing fingers at today's government. I think all governments, regardless of political stripe, could be accused of this. But I do know that you met with officials from Health Canada, and one of the things you wanted was a public inquiry. Is this as close as you've come to a public inquiry with Health Canada?

    Ms. Brenda Johnson: Yes, sir.

    Mr. Greg Thompson: Okay. You're being very polite in allowing me to continue.

    What upsets me is that they wrote the minister seven months ago. It's hard to believe that the Minister of Health hasn't responded, because it's a political problem. Every problem is a political problem in a sense, but that shouldn't prevent the Minister of Health from addressing a real concern and a serious concern. To add to that frustration, it has been pointed out by Julia Hill from the Department of Health here today that they look at it as a marketing problem.

    Then our witnesses from the diabetes society say, reading from their letter dated July 22, 2002, that:

We have been told on numerous occasions by Health Canada officials that the government has no authority to tell pharmaceutical manufacturers what products they must market.

They were told to contact the Competition Bureau, which would be another department. The Competition Bureau said they were concerned about this, but they were told it was a health issue so they couldn't do anything. So we're back to square one again.

    The question I have for the representative of the Department of Health, Julia Hill, is what did your department do upon learning about this? Did you sort of gather in a room, talk about it, and then conclude there was nothing you could do? Taking notes from your statement--and I think this is accurate--you recognized the difficulties; you recognized the marketing difficulties; you recognized the difficulty of bringing them to the table and forcing them to do something, but how did you arrive at that conclusion?

    Did you meet with your legal department? Do you have notes of those meetings that you could actually present to the committee so we could analyze and scrutinize those discussions internally within the department to determine how to grapple with this from a legal point of view?

    Has there been any discussion at those higher-level meetings within the department--as I think my friend from the NDP has mentioned--on using some moral authority, in terms of the responsibility of drug companies to say, “It is a marketing problem, but on the other hand, we're producing a synthetic drug here that is obviously costing us less money than the animal version, and there is possibly an obligation on our part to ensure we do the best as a company to assist those citizens we've assisted over the years”?

    Have you done that? Have you called some of those company officials into your department to discuss that? And when those discussions were held, were legal representatives from your department and the Department of Justice there to hear some of what they had to say?

    Ms. Julia Hill: This is not the only time we have been faced with this issue of an inability to require a company to either market a product or not withdraw a product. It is a frustration within the department. We have had legal consultations many times. We have had many legal opinions on our authority to oblige a company to market a product. The response has been quite consistent that we do not have that authority.

    On moral suasion, we do have discussions with companies. We talk to them about how we might facilitate their application process and what we can do to make it easier for them. Moral suasion sometimes works, but when it's balanced against a company's bottom line, we tend to have less power.

    Mr. Greg Thompson: Madam Chair, do I have another minute or two?

    The Chair: Yes. I'm just so excited that you're present. You're going to be spoiled for our first few meetings, then I'll just crack the whip.

    Mr. Greg Thompson: Thank you very much.

    When those meetings take place and those legal recommendations are rendered, are they recorded and documented in such a way that they can be referenced for future discussions? We often hear around this place that government is more reluctant to say “yes” than “no”, because “no” is an easier answer. “Yes” might require a little more work and a little more ingenuity, and it's often a tougher challenge.

    So is it possible that you could provide us with some of the legal analysis and some of those discussions that took place within the department? Or are those all covered by the Privacy Act?

    Ms. Julia Hill: I would have to return to the department to see. Some of these are legal opinions to the Minister of Health, but I believe there must be some way in which we can provide members of the committee with information that would help. I would certainly commit to doing that on my return.

    Mr. Greg Thompson: It would be helpful, Madam Chair, if that could be provided to us. I think we'd have a starting point. We want to see the problem corrected; that's what we're here for today.

    Ms. Julia Hill: I might just add, Mr. Thompson, that it is in fact not easier to say “no” than “yes”. When we are dealing with real people who call us up and tell us about the issues they are dealing with on a daily basis, or when diabetic members of our own staff may be dealing with these issues as well, it isn't easier to say no.

    Mr. Greg Thompson: Madam Chair, I have just one short supplementary.

    We do know that in the native community the diabetes problem is a much bigger problem, and we do know that the reporting mechanisms probably aren't as good as they should be. Have you made any special effort to identify those problems that have been expressed here today? You have a stronger--that is the word I'm using--responsibility for our native people from a health point of view, and you have a direct responsibility to them in providing health care. Would you have a set of statistics that might not be in line with the general statistics in greater society, if you will, or that would reflect this problem in the native community?

    Ms. Julia Hill: I must apologize, but it had been our understanding that somebody from the First Nations and Inuit Health Branch would be here. They do the direct service delivery.

    The Chair: Oh, she is here.

    I'd ask you to come to the table, please, and introduce yourself.

    Ms. Maureen Thompson (Manager, Diabetes Program, First Nations and Inuit Health Branch, Department of Health): Ms. Maureen Thompson (Manager, Diabetes Program, First Nations and Inuit Health Branch, Department of Health)Certainly. I'm Maureen Thompson, and I'm program manager for the aboriginal diabetes initiative.

    I was sitting in the audience and not at the table because our program doesn't deal with access to drugs or adverse drug reporting; our program deals with prevention and awareness and starting to build capacity of first nations and Inuit people to manage their own diabetes programs. That's what we're doing with the first phase of the Canadian diabetes strategy. It's now under way.

    In terms of adverse drug reporting, I'm not aware that this is done for first nations specifically. There's a lot of difficulty involved in identifying first nations people separate from the general population, unless they choose to self-identify.

    I hope that answers your question.

    The Chair: Don't you have a non-insured health benefits program that's part of...? Probably someone you work with would have been able to answer this question.

    Ms. Maureen Thompson: There is a non-insured health benefits program, and I believe there is a representative here, Georges Nadon.

    The Chair: Oh, surprise, surprise.

    Come forward, please.

    People are so shy, and yet we're so nice.

    Mr. Georges Nadon (Pharmaceutical Consultant, Non-Isured Health Benefits Program, Firsts Nations and Inuit Health Branch, Department of Health): I'm Georges Nadon, one of the pharmacists with non-insured health benefits.

    To pick up on what Maureen was saying, first nations are served by the same health care providers--doctors, pharmacists, and so on--as the general population, so the mechanism they would use to report any side effects would be the same as for the overall population.They have to fill out those forms to be sent to Health Canada to report on side effects. They access drugs the same way as any other Canadian, through pharmacies and doctors' prescriptions. They are responsible for reporting these side effects if they are made aware of them.

    Mr. Greg Thompson: Is there a disproportionate number of deaths from diabetes in the native community compared to the greater society? In other words, can you actually make the link between the number of deaths that might have occurred in the native community versus the general population, based on the use of animal insulin versus human insulin?

    Mr. Georges Nadon: I can't make that link.

    The Chair: Can Dr. Sharma answer that question? Does Dr. Sharma work with Dr. Turner?

    Dr. Supriya Sharma: We do work together.

    The Canadian adverse drug reaction monitoring program collects data on adverse reactions in Canada. There is no specific designation for ethnicity on the form. Should that information be volunteered as part of the adverse reaction report, it can be reported and documented.

    On the number of deaths we suspect may have been linked to insulin products, none had ethnicity specified, so we can't tell if those patients were aboriginal or non-aboriginal.

    There isn't a specific outreach to that population in terms of soliciting increased reports. However, there are regional adverse drug reaction centres, and the funding to those groups has just been doubled to try to increase outreach and increase the receipt of adverse reaction reports. It's not just a matter of the number of reports, it's the quality of those reports, the amount of information, and the ability to follow up on those reports and glean some sort of useful information from what has been submitted.

    The Chair: Thank you, Mr. Thompson.

    We'll move to Mrs. Chamberlain, at whose request this meeting is actually happening. Because of her we are beginning to get some of these interesting facts.

    Mrs. Chamberlain, the floor is yours.

    Mrs. Brenda Chamberlain (Guelph—Wellington, Lib.): Thank you.

    In fairness, I want to give the chairman due credit. After I talked to Brenda Johnson, I immediately phoned the chairman and she agreed to at least bring this forth, to determine whether the committee would consider it. It's been a joint effort and I thank you, Madam Chairman. This is very important.

    I want to see if I understand this correctly. Eli Lilly is producing animal insulin. Is that correct?

    Ms. Brenda Johnson: They produce it in the States. We import it.

    Mrs. Brenda Chamberlain: So you can get that now.

    Ms. Brenda Johnson: Yes, as of today.

    Mrs. Brenda Chamberlain: So why did you go somewhere else? Did you not say you went overseas somewhere?

    Ms. Brenda Johnson: Yes, CP Pharmaceuticals; I import beef insulin from them. After my horrible, horrific experiences on synthetic insulin, I switched to pork. By the way, immediately upon switching to pork I got my symptoms back, which was the best gift ever, I can tell you, after suffering seizures, blackouts, a coma, and so on from the synthetic insulin.

    Still, I found that the pork was a little too fast-acting for me. For me, it was a little too strong, so I made the decision that I owed it to myself to try the beef, and I'm doing wonderfully on it.

    Mrs. Brenda Chamberlain: It seems to me that Health Canada has honestly tried to go and see what they could do, and I think you really have a good understanding of this. But if this is in jeopardy, and people can't get the insulin they need--which they were able to get at one point--this just doesn't seem right to me, in Canada. Does it to you?

    Ms. Brenda Johnson: It is a tragedy beyond belief for many reasons. One of the reasons is just strictly from the standpoint that Canada is responsible for the discovery of insulin in the first place, and went on to save millions of lives around the world. Now we don't even make a single drop. That is so tragic to me.

    The fact is, we have to sit here and beg someone, anyone—whether it's Health Canada, the politicians, the chair of this committee, or whoever it is—and say, “We need this drug to survive; we cannot safely use synthetic insulin.” And if it is true—and we believe we have the proof—that Eli Lilly has plans to discontinue it, and in fact has already ceased production, the existing supplies in our little group will only last until 2004, or maybe until early 2005. This doesn't give us an awful lot of time to do what we are here today to ask you for help with: either find another supplier; or subsidize CP Pharmaceuticals, Novo Nordisk, or some other manufacturer, to bring their insulins into Canada. Let's subsidize the licensing fees, or reduce them. Somebody has to take the bull by the horns and say, “Look, we have a problem here. Very soon, by the year 2004 or 2005, these people aren't going to have a supply, period.”

    When I was talking about my previous imports from CP Pharmaceuticals, to pay $930 for a six-month supply is a horrendous amount of money. It is very unfair to me or to anybody. We have many people in our group who are on fixed incomes or on disability, especially because of the problems they've had over the years. They have lost their jobs, their licences, and whatever, because of the effects of synthetic insulin. How can these people afford $930 every six months? It's just impossible. It's a horrible situation.

    Mrs. Brenda Chamberlain: Mrs. Hill, do you agree that Eli Lilly is going to discontinue this? Do you know this?

    Ms. Julia Hill: No, we don't.

    As I mentioned in my remarks, when we have asked them, we have received an affirmation from them that for the time being they are continuing to produce. Certainly that doesn't give us the comfort level we would like.

    Just to add to Ms. Johnson's comments, we are aware in the health field that diabetes is one of the greatest and growing concerns for Canadian health. We're talking about a number of people at the moment, whom we are aware of, who need animal-source insulin. We have no idea how these numbers may grow in the future.

    This is a very important, productive part of our society. Somehow we need to find a solution. We're ready to be there, but we don't have a magic wand.

    Mrs. Brenda Chamberlain: To the chair and the committee, I think we have to put a motion on the floor asking Health Canada to come back with some solutions to this. Because if this information from Health Canada is true—the group says it's not—that it's 200,000 people, that's a lot of people.

    Ms. Brenda Johnson: They are not all insulin-dependent diabetics.

    Ms. Colleen Fuller: We're not saying that all of the information in the safety bulletin is wrong. We're saying the way it addressed some of the issues around human insulin is wrong. It is not helpful in properly informing the medical community about synthetic and animal insulins. That's what we're saying.

    Mrs. Brenda Chamberlain: But I think the crux of it is that Health Canada is not disputing there's a need for this; we don't know if we have only one source, and if there is any truth to this. I don't know if there's an ability to find out, through the department or whatever, if this is going to be discontinued. Because if it were to discontinue, it would be a terrible thing.

    Ms. Julia Hill: If we knew ahead of time that they were intending to discontinue, it would put us in a better position as well with anyone else who might wish to come in with a submission.

    Mrs. Brenda Chamberlain: Exactly.

    Ms. Julia Hill: But we have asked those questions. Eli Lilly is quite...and frankly, we would have no reason to not take them at face value, either. They have repeated on every occasion that it is their intention to ensure availability of this product to Canadians.

    That said, I must confess that when we see “at this time”, and those necessary riders, it gives us cause for concern as well.

    Ms. Brenda Johnson Our group received confirmation from the International Diabetes Federation. It is a huge organization that encompasses the American Diabetes Association, the Canadian and British, and is worldwide. They had an insulin task force set up many years ago to address the global withdrawal of animal insulins. We received confirmation from this task force, saying that, yes, it is true, Eli Lilly has discontinued already.

    Naturally, then, you can understand our urgency in this matter, and why we again put together this trip back to Ottawa to address the problem. We are simply running out of time.

    The Chair: It's somewhat understandable, Mrs. Chamberlain, that Eli Lilly does not want to say that they're going to stop supplying, because if they have tanks and tanks of this or whatever, or the capability of doing it, they are going to want to have the monopoly they enjoy until their supply is gone.

    Mrs. Brenda Chamberlain: Exactly.

    The Chair: They're not going to announce it to the world in order to get another competitor in right away, which we might be able to get if the competitor abroad knew that Eli Lilly was stepping back from the market.

    Mrs. Brenda Chamberlain: This is a question, Madam Chair, for you to give some thought to. Do we need a small in camera session at some point, with the committee and perhaps Health Canada, to come up with some recommendations?

    The Chair: I think so, but not everyone has had a question.

    Mrs. Brenda Chamberlain: No, I agree.

    The Chair: Could we go on?

    Mrs. Brenda Chamberlain: Absolutely. It wouldn't even have to be today if you don't want to. I think, to me, it would be perhaps a reasonable next step. Then the minister has to be brought into the picture.

    The Chair: Okay, thank you for that.

    Dr. Bennett.

    Ms. Carolyn Bennett: Have we invited Eli Lilly to come?

    The Chair: No. We may want to meet as a group to discuss what we can do next.

    Ms. Julia Hill: Madam Chair, sorry, I have one other comment. It's not in defence of Eli Lilly, but I would like to point out that they did remain on the market when others made choices to withdraw. As a question of fairness, I think that needs to be noted.

    Thank you.

    The Chair: Yes.

    Ms. Skelton.

    Mrs. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance): Ms. Johnson, you said you import your insulin. Do you have to go through this special access program of Health Canada? How many hoops do you have to jump through to get the insulin? Is it a difficult task?

    Ms. Brenda Johnson: It took me six weeks to get my order. Since that time, I have been working with Ian MacKay. We are trying to come up with some solutions on how to restructure the actual instructions for doctors and patients to get this more quickly. I think we've come up with some good solutions, but the bottom line is that the paperwork and the cost are horrendous.

    Interestingly enough, because it is not considered to be a legal drug in Canada, when the insulin is delivered it has to go either to your doctor's office or to your local hospital pharmacy. If it goes to the doctor's office, nine times out of ten they're not open over the weekend, and their hours are erratic. It's not at your convenience that the insulin comes to you.

    Another very important point about the special access program is that when you order your beef insulin from CP Pharmaceuticals, you have to pay cash up front through MasterCard or whatever. They do not accept any responsibility for the delivery of the insulin. Therefore, there are situations like we saw after 9/11, where we heard, not necessarily for Canadians, that some of our American friends had shipments held up.

    It also compromises the integrity of the insulin itself if it's left sitting on a hot pier in New York City. Unfortunately, the person who has bought the insulin and perhaps spent $930 has no recourse.

    Mrs. Carol Skelton: You said it's $930. How much do you pay Health Canada? Do you have to pay Health Canada for allowing it in?

    Ms. Brenda Johnson: Oh, no.

    Mrs. Carol Skelton: I just wondered.

    Ms. Brenda Johnson The costs involved are the actual costs of the insulin itself. There is a shipping charge from CP Pharmaceuticals, which depending on the exchange rate of the day is in the neighbourhood of $100. Then you pay customs and brokerage fees. So the grand total of all of that is $930. When you break it down by vial it is $56.11 per bottle.

    Mrs. Carol Skelton: When you're diagnosed as a diabetic and put on synthetic insulin, do you know how many reactions there are immediately?

    Ms. Brenda Johnson: Do you mean insulin shock?

    Mrs. Carol Skelton: Yes. How many reactions are there?

    Ms. Brenda Johnson: It varies from person to person. But there is one thing I want to point out to the committee. I can remember sitting back many times thinking, how am I going to explain to people what the difference is between a reaction on animal insulin and one on synthetic insulin? If you've never experienced it, how can you possibly understand?

    I hate to keep using myself as an example, because there are so many thousands of us with the same problem, but the differences between a reaction on animal insulin and a reaction on synthetic insulin are very real and terrifying. That's the best way I can put it.

    Synthetic insulin has a much quicker, unexpected, unexplained reaction profile, so it leaves you incapacitated. I have tried so many times to explain to people that not only are insulin reactions on synthetic insulin more profound, they're more prolonged. They're debilitating.

    On pork or beef insulin, especially since I switched back, if I'm having a reaction I get the usual shakes or tremors or the odd feelings you get. I can go to my fridge, get some juice and a cookie, or whatever, and five minutes later I'm fine. On the synthetic insulin, the reaction would be drawn out for an hour. I would lose time. I would lose--

    Ms. Colleen Fuller: Consciousness.

    Ms. Brenda Johnson: Yes, consciousness.

    I could be sitting there talking to you like I am right now and seem quite fine, and then go into what I called a brown-out, which is unconsciousness but your eyes are still open and you can't communicate. You're convulsing, and so on. This simply never happens on animal insulin.

    My resumé is long. I've been a diabetic for 33 years. I've been on every type of insulin and every gadget and gizmo that comes with it--the insulin pump, the insulin pen, synthetic insulin, beef insulin, pork insulin, beef and pork insulin--and believe me, the differences are terrifying.

    Dr. Jan Braaten: I've heard this story many times, and what told you was very well said. It is exactly what other patients say. On animal insulin they can feel it coming and control it, but when they get new insulin, they go into reaction and can't control it. I've heard it over and over again.

    So that was a very nice description of how people feel. It's genuine. It's real.

    Ms. Colleen Fuller: Perhaps I can add one thing.

    You were asking about newly diagnosed patients who have not been on animal insulin. In our organization we have people who range in age from 6 years old to about 73 years old. Of course, the younger the person is the less likely they will have been on animal insulin.

    The experiences that younger people have is a special area that needs a lot more work and study. Those of us who are on animal insulin know what an insulin reaction is supposed to feel like. We know that insulin is supposed to stabilize your blood sugar levels, and so forth. Younger people haven't had the experience that those of us who are on animal insulin have, and are unable to make the distinction.

    But we have heard way too many stories about newly diagnosed diabetics who, after three or four months, are losing their ability to tell when their blood sugars are dropping, and have no ability to control their blood sugar levels. I have no idea what the percentage is.

    A member of our organization represents a family support group in Ontario, with about 143 families. He estimates that about 20% or 25% of the children in those families have a typical profile--that is, they cannot tell when their blood sugar is low; they experience not the normal insulin reaction, but severe hypoglycemia; they experience memory loss; they have no ability to focus or concentrate; they have diarrhea and vomiting, and so forth and so on.

    I don't know how many people, newly diagnosed diabetics, have these problems, but I think we need to find out.

    The Chair: Thank you, Ms. Skelton.

    I have a few questions, if the committee can stand a few more minutes.

    Ms. Carolyn Bennett: And I have a tiny one.

    The Chair: Okay.

    My understanding from my researchers is that this Cochrane review, in most cases, is considered the gold standard in analysis of such things as drug products and reactions.

    I'm wondering why Health Canada is doing another study, Dr. Sharma, when they already have one, particularly when it didn't seem that you were aware of the Cochrane review, and the diabetes association had to supply you with it.

    Dr. Supriya Sharma: We're actually not doing a separate study. Basically, what we've contracted....

    The Cochrane review, in terms of methodology, is thought to be very good in a lot of different ways in terms of studying overall themes in numbers of studies. So it gives you a way, instead of looking at 80 patients here, 800 patients here, and 1,000 patients here, to try to make generalizations of the data. Undoubtedly it's one of the ways of systematic analysis.

    The Cochrane review is a methodology, and you can apply that review in a lot of different ways. It is standardized to a certain extent, but there are, for lack of a better word, “different-quality” Cochrane reviews.

    There's a group that specializes in the epidemiology and actually doing these studies, so what we've done is to take a look at it and say, as far as Cochrane reviews and those analyses go, how does this stack up? What kind of quality review is this? There have been other Cochrane reviews that, when you look at it from an epidemiologic basis, don't look so great, and some of the conclusions that have been drawn from them don't necessarily stand up to rigorous scientific or statistical analysis.

    That is not the case with this Cochrane review. It seems to be a well-thought-out study. The assumptions that are made, or the other changes or analyses that were made in this study, seem to be valid, and the conclusions they've drawn seem to be valid, but we wanted to make sure we had experts in that form of analysis take a look at it and tell us, yes, it's a good study; yes, it's well done; yes, the conclusions that they've drawn are valid.

    So it's not a separate study; it's a review of the review.

    The Chair: Okay.

    Now, at the end, if in fact it is concluded that this is a very good study, one of the conclusions is that large-scale drug utilization studies should evaluate the situation of worldwide insulin species use, focusing on the developing world. So it seems to me that if we're going to do more studies, we should follow the suggestions that follow the conclusions of the Cochrane report.

    One of their conclusions was that:

 

“human” insulin was introduced without proof of being superior to animal insulin; that studies have not assessed patient-centred outcomes like satisfaction, health-related quality of life and diabetes-related morbidity.

Furthermore, it did not report on qualitative assessments of patients' own experiences when using different insulin species.

    I, for one, found Ms. Johnson's explanation of the difference in her reaction to animal and human insulin to be very enlightening. I thought it was very well described, so the thought you put into it ahead of time....

    I mean, I got the message, that one hits you like a ton of bricks, and you can't take the ameliorating methods you used to, when you hurried to the refrigerator to get orange juice. That's pretty clear. And it doesn't seem that anybody has really collected those kinds of descriptions from the people themselves. However, you've explained about the study.

    Ms. Hill, you talked about, and I really appreciated your sensitivity here, the patients who are experiencing all this. That's wonderful, but then you talked about this pamphlet, called “It's Your Health”, which, in the background part, says these human insulins “are more effective and have an excellent drug safety record”. That may be true for the majority of patients, but you don't say that.

And you don't mention the fact that some people are having trouble with them. Then you even give an ad for Eli Lilly and the other drug company. You say that the other products are “so popular”, the drug companies have stopped selling beef-pork. So you give a reason for the withdrawal of the other products from the market.

    I don't think this has anything to do with being so popular. I think it has to do with being able to be produced so cheaply. Then once you withdraw the beef and pork, you bump up the price of the one that used to be $7, and which is now $22. So all of a sudden your profit margins triple.

    Now, I don't see any indication of this. This looks like an ad to support the status quo that has evolved over the last few years, instead of a tough, questioning thing that doctors could get, and which could maybe really help these people stir up some trouble—because that's what it is.

    A voice: I don't know how much help they need.

    Voices: Oh, oh!

    The Chair: I want to know who wrote this. In a written reply from you, I want to know who wrote this and who approved it, because I think it's a disgrace.

    Ms. Julia Hill: And it so needs to be rewritten.

    The Chair: Well, no, it was never true in the first place. It's an ad.

    Ms. Julia Hill: If I may, it was written in response to issues we were dealing with at the time. There had been a fair amount of communication suggesting that human insulin should be completely withdrawn from the market. There was a concern about the panic this was creating in certain quarters.

    The Chair: I see. And when was this written?

    Ms. Julia Hill: It came out last May.

    Mr. Greg Thompson: So it was at the same time, Madam Chair, that we were talking about genetically altered foods.

    The Chair: Last May? So it's not that old.

    Ms. Julia Hill: Well, in terms of our evolution and our awareness—

    Mr. Greg Thompson: It says July 2000 on it, doesn't it?

    The Chair: I want to ask another question. I liked Mr. Thompson's question about the legal recourses that governments have. I have two questions based on this.

    I understand and I learned a long time ago, to my dismay, that we can't control drug companies and what they put on the market. It's very sad. But the cases I deal with in my constituency office are often from the only patient in my constituency, or maybe in the whole greater Toronto area, who has some really, really weird disease for which there is a medication available in Europe, but it's obvious to me that the company doesn't want to invest in the whole process of getting its drug approved here, if we only have 10 known patients in the country. And I understand that.

    Is there any other situation where people are going to have to go through your program, Mr. MacKay, where the potential numbers of patients are as high as those with diabetes? Or is it more what I have experienced—very small numbers and rare diseases?

    Mr. Ian MacKay (Unit Head, Special Access Unit, Clinical Trials and Special Access Programme, Senior Medical Advisor Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health): The special access program was originally designed to address the needs of small numbers of patients, as you've described. The situation we've seen with the withdrawal of the animal insulins, and the need to access the product from the United Kingdom, has still only involved relatively small numbers. I think we're dealing with about 21 patients, in addition to those who are currently on the approved pork insulin.

    With respect to other products, we have seen a number of products withdrawn from the market over the last number of years, in the same way some insulins have been withdrawn. This has led to a run on these products, if you will, and pressures to bring in large quantities of drugs to address these needs. So while the core work of the SAP deals with small numbers of patients, we've been seeing growth in the number of products withdrawn from the Canadian market for corporate reasons, and which out of necessity have had to be made available through the special access program.

    The Chair: All right. Thank you.

    But are any of them producing, or do they have the potential to produce, the numbers required to address the problem created by human insulin?

    Mr. Ian MacKay: Certainly, there are some drugs in the program now that have been withdrawn from the Canadian market and that would equal or exceed the numbers of patients currently confronted with the insulin problem.

    The Chair: You were suggesting that there could be large groups of patients, and drug companies are withdrawing the most commonly used drug, so these people may have to come to you for the special access program. How may would there be--four, five, six, or more?

    Mr. Ian MacKay: Unfortunately, there are many more than that.

    The Chair: How many are there? Just give me a ballpark figure.

    Mr. Ian MacKay: In the last number of years we've probably dealt with somewhere in the order of 30 to 40 products that have been withdrawn from the market, which have--

    The Chair: Did that involve a large number of consumers?

    Mr. Ian MacKay: Large numbers, no; would be about half that. The rest of them would be smaller numbers. Maybe in the order of about 15 drugs that would represent...that have been withdrawn where there would be large numbers of patients--i.e., more than the number of diabetics we've encountered.

    The Chair: Maybe you make a chart for us showing the name of the drug, what it addresses, when it was withdrawn, and how many people seem to have been affected by that withdrawal. It doesn't have to be absolutely precise, like a scientific chart, just your best guess based upon your experience.

    Mr. Ian MacKay: We have accurate numbers on that, not just ballpark figures. So that's something we can commit to providing.

    The Chair: Great.

    Ms. Julia Hill: Perhaps that could be done with the researchers of the standing committee. I would just be concerned about taking too much time from the actual management of the special access program for research--

    The Chair: He said he already has the numbers, so why would it take any time? Doesn't he just punch it out of the computer?

    Ms. Julia Hill: I'm just thinking, Madam Chair, that in terms of doing charts and determining exactly what your requirements would be, we could collaborate.

    The Chair: They would help you, for sure.

    Ms. Julia Hill: Thank you.

    The Chair: I have one more question. The time is really up, and I'm testing the patience of my colleagues.

    We're trying to think of what power we have, and there are two ideas here. First, the government helped to start up Connaught, and I believe there was an agreement that they would be responsible for insulin. Connaught was bought by Aventis Pasteur. When they bought Connaught, did they get out from under its obligations? What do you know about that? Is that something the legal staff, the justice people, could help you with, Ms. Hill?

    Ms. Julia Hill: Actually, Ms. Fuller was just saying that she thinks she knows the answer to that.

    The Chair: Ms. Fuller.

    Ms. Colleen Fuller: You probably remember that there was a big stink about the sale of Connaught.

    The Chair: Yes, but I didn't know why.

    Ms. Colleen Fuller: I don't know all of the ins and outs as to how the insulin question was settled. Connaught was in a partnership with Novo Nordisk, and by the time it was sold to Aventis, they were no longer producing their own insulin. There was a distribution agreement with Novo Nordisk, and they were distributing Novo insulins in Canada. However, a lawsuit was launched by the University of Toronto, which I think was against Connaught, actually, because of the violation of the insulin agreement. I don't know the ins and outs of it. That's as much as I do know. I don't know how it was settled. The lawsuit was withdrawn.

    The Chair: Is there somebody here from Health Canada who could find out? I'm sure the Government of Canada was at least observing that whole lawsuit, seeing that it was our contract with Connaught in the first place.

    Ms. Hill.

    Ms. Julia Hill: We can certainly ask the question and see what we're able to provide you with.

    The Chair: Thank you very much.

    I have one other question. In your attempts to get your oar in the water in order to have some clout in this area, have you ever launched an inquiry or a protest or something to the PMPRB, the Patented Medicine Prices Review Board, considering the tremendous jump in the price of human insulin after the withdrawal of animal insulin?

    Ms. Julia Hill: Health Canada has a very narrow, specific mandate within which we are required to operate. We assess the safety and efficacy of products. Under the current system in Canada we have no connection with the way in which prices are set. That's to ensure that--

    The Chair: Does the PMPRB come under Industry Canada, then?

    Ms. Julia Hill: It's an arm's length--

    The Chair: But that particular body reports to the Minister of Health.

    Ms. Julia Hill: But it's quite separate from the regulatory arm, and there are walls there intentionally.

    The Chair: Okay.

    We'll have a short question each from Dr. Bennett and Ms. Wasylycia-Leis.

    Go ahead, Dr. Bennett.

    Ms. Carolyn Bennett: I don't think anybody would think that patients, and their clinicians, don't know best what works and doesn't work for them in terms of optimal therapeutic choices. In an optimal health care system, we should be able to provide that buffet of choices for people to have what they know they need.

    As well, I guess I still need to hear from Brenda and Colleen, who are I think pretty impressive, on whether they think the actual therapeutic treatment of diabetics in Canada has been skewed in a way that may not be the best for kids in that everybody needs to have the full buffet tried after diagnosis, and a number of people are immediately being put on human when maybe the buffet would have been better for them.

    What I'm hearing from you is that you think, with this lack of choice, some people may be receiving suboptimal treatment. Is that your opinion?

    And what are your suggestions as to who else we should speak to about this? I don't get why the generics haven't picked it up. Should we hear from the generics? Who else would you like us to hear from in terms of why there's this market vacuum on something that you and the people you talk to feel you really need?

    Ms. Colleen Fuller: There were 45,000 people on animal insulin in 1995, and that market was very intentionally destroyed by the two companies that make it, Novo Nordisk and Eli Lilly. And I do mean they destroyed the market. It wasn't that people woke up on Monday and said, “Let's try human insulin”; it was literally destroyed. So for another company to come in and try to recreate the market is a challenge, I think, and I don't know how companies will deal with that.

    From my perspective, until animal insulin became very difficult to obtain, the position of the Canadian Diabetes Association was that the first line of treatment should be animal insulin, and there was no reason to put anybody on human insulin unless they were having problems with animal insulin. Roughly 1% of people had problems with animal insulin at that time.

    Those are the challenges now. More people are starting to use pork insulin because of the work we've done to let people know that pork insulin is available. People are now contacting us, of course, because they're worried it's going to be pulled. But it's a huge amount of work to get the information out there and to look at, and possibly revise, the treatment guidelines.

    So I don't know the answer to your question, but this is what I do know. By the most conservative estimates, if the amount of people in Canada having problems is 1%, we're looking at 2,000 people who have a problem. If we go with the Swiss estimate of roughly 10%, we're looking at 20,000 people. Those numbers would include those both currently diagnosed and those yet to be diagnosed.

    We need a strategy to deal with this. That's what I think.

    The Chair: Thank you.

    A quick one from Mrs. Wasylycia-Leis.

    Ms. Judy Wasylycia-Leis: Madam Chair, thank you.

    I think if there ever was a reason for proving, or trying to make the case, that access to health care shouldn't be market driven, we've heard it today, and I think that's the issue we need to grapple with as a committee.

    Madam Chair, we've heard that the department has felt immobilized to act in this regard, and yet we know of other examples where the government has acted. Look at the issues around waging war, or responding to anti-terrorism. The former Minister of Health was going to actually bypass patent law in order to make the anthrax vaccine available. And if Canada, God forbid, joins with the U.S. in terms of a war on Iraq, and there's a shortage of anthrax vaccine, we know somebody will find a way to make it available.

    I think we need to look at the broad issue of the role of government and the role of the Health Protection Branch. And not to dump on the officials here, we need to get the minister or the top officials before a committee, to be held accountable for this. Because this is not just about moral authority, it's also about legal authority. We have an act that requires access to necessary drugs as part of our legal framework.

    So I think we need to find out how to apply the existing law and the regulatory framework in terms of safety and efficacy issues around such basic things as notice and information that goes out to patients, and we need to look at how we can guarantee a supply and take the necessary steps.

    I don't agree with Carolyn that the onus should be on any of you, as the diabetes association, to go and start a business. I think we are talking about universal health care with an onus on the government to make sure that the--

    The Chair: Judy, I don't hear a question, I hear a really big speech.

    Ms. Judy Wasylycia-Leis: My question is, since this is our last chance before we pursue this issue further, what final recommendations would you make in terms of our report to Parliament in terms of an action plan on this issue?

    Ms. Colleen Fuller: I would like the committee to recommend to the Department of Health that they develop a strategy to ensure that Canadian diabetics who require or who want animal insulin are able to go to the local pharmacy and get it--both beef and pork insulin. I think there does need to be a strategy to reach that objective.

    That's what I would like.

    The Chair: Perhaps 25 years ago it would have been an easier job for Health Canada to do, but I think the establishment of the Patent Act in 1988 and the establishment of the PMPRB put the walls between Health Canada and the drug companies. This whole prices review mechanism was to make sure it was fair to the drug companies, so it seems to me that Health Canada and various others were sort of shut out.

    That's the problem with these arm's-length bodies; they're a good idea at the time, but then they get in your way later.

    I think also that we can't expect Ms. Johnson and Ms. Fuller...because this is a whole power thing. This is about who has the power to do whatever they want or not, and we're supposed to figure that out. So I'm grateful for the work they've done to keep it alive and to keep it moving, but my conclusion is that the ball's in our court. This needs political clout, and the officials at Health Canada also need our help.

    Ms. Carolyn Bennett: But a partnership may be possible between the government and the voluntary sector when the private sector bows out.

    The Chair: I couldn't agree more. I'm not trying to say it's one way or the other. I'm just trying to say that how to do it is really ours to solve.

    Mrs. Brenda Chamberlain: I don't think we should broaden this. I think we should try to fix this problem right here.

    The Chair: Oh, I agree.

    I was hoping the answer I was going to get out of Mr. MacKay was that there was no other drug pull that affected quite so many people, but I didn't get that answer, which is why I was going to say to focus on this one.

    Thank you very much, ladies and gentlemen.

    I may have to cancel Wednesday's meeting. We were supposed to do Bill C-260, but I'm sure you want to be in the House when Bill C-13 is there because they're voting on it. And if they're voting without us, who knows what they might do with it. The clerk will keep monitoring it to see if our bill is in the House.

    This meeting is adjourned.