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37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Tuesday, April 29, 2003

0905

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Mr. Terry McCool (Vice-President, Corporate Affairs, Eli Lilly Canada Inc.)

Dr. Loren Grossman (Vice-President, Research and Development, Eli Lilly Canada Inc.)

0910

The Chair

Ms. Alexis Mantell (Senior Manager, Strategic Communications and Media Relations, Canadian Diabetes Association)

0915

0920

The Chair

Ms. Diane Allingham (Executive Assistant, Public Policy and Government Relations, Canadian Diabetes Association)

The Chair

Ms. Julia Hill (Acting Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health)

0925

The Chair

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

Dr. Loren Grossman

0930

Mr. Rob Merrifield

Dr. Loren Grossman

Mr. Rob Merrifield

Dr. Loren Grossman

Mr. Rob Merrifield

Dr. Loren Grossman

Mr. Rob Merrifield

Dr. Loren Grossman

Mr. Rob Merrifield

Dr. Loren Grossman

Mr. Rob Merrifield

Ms. Julia Hill

Mr. Rob Merrifield

0935

Ms. Julia Hill

Mr. Rob Merrifield

Ms. Julia Hill

Mr. Rob Merrifield

Dr. Loren Grossman

The Chair

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.)

Dr. Loren Grossman

0940

Mr. Jeannot Castonguay

Dr. Loren Grossman

Mr. Jeannot Castonguay

Dr. Loren Grossman

Mr. Jeannot Castonguay

Dr. Loren Grossman

0945

Mr. Jeannot Castonguay

Dr. Loren Grossman

Mr. Jeannot Castonguay

Dr. Loren Grossman

Mr. Jeannot Castonguay

The Chair

Mr. Larry Spencer (Regina—Lumsden—Lake Centre, Canadian Alliance)

Dr. Loren Grossman

Mr. Larry Spencer

0950

Dr. Loren Grossman

Mr. Larry Spencer

The Chair

Ms. Hélène Scherrer (Louis-Hébert, Lib.)

Dr. Loren Grossman

Ms. Hélène Scherrer

Dr. Loren Grossman

Ms. Hélène Scherrer

Dr. Loren Grossman

Ms. Hélène Scherrer

Dr. Loren Grossman

Ms. Hélène Scherrer

Dr. Loren Grossman

Ms. Hélène Scherrer

Dr. Loren Grossman

Ms. Hélène Scherrer

Dr. Loren Grossman

0955

Ms. Hélène Scherrer

Dr. Loren Grossman

The Chair

Mr. Svend Robinson (Burnaby—Douglas, NDP)

The Chair

Mr. Svend Robinson

The Chair

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance)

Dr. Loren Grossman

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

Dr. Loren Grossman

1000

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

Ms. Julia Hill

Dr. Supriya Sharma (Director, Marketed Biologicals and Biotechnology Products Division, Marketed Health Products Directorate, Health Products and Food Branch, Department of Health)

Mr. James Lunney

Dr. Supriya Sharma

Mr. James Lunney

Ms. Alexis Mantell

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

Dr. Loren Grossman

1005

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

The Chair

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Dr. Supriya Sharma

Mr. Svend Robinson

Dr. Supriya Sharma

Mr. Svend Robinson

Dr. Supriya Sharma

1010

Mr. Svend Robinson

Dr. Supriya Sharma

Mr. Svend Robinson

Dr. Supriya Sharma

Mr. Svend Robinson

Dr. Supriya Sharma

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Dr. Supriya Sharma

Mr. Svend Robinson

Dr. Supriya Sharma

Ms. Julia Hill

1015

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

The Chair

Dr. Loren Grossman

The Chair

Dr. Loren Grossman

1020

The Chair

Dr. Loren Grossman

The Chair

Dr. Loren Grossman

The Chair

Mr. Terry McCool

The Chair

Mr. Terry McCool

The Chair

1025

Dr. Supriya Sharma

The Chair

Dr. Supriya Sharma

The Chair

Dr. Supriya Sharma

The Chair

Dr. Supriya Sharma

The Chair

Dr. Supriya Sharma

The Chair

Dr. Supriya Sharma

The Chair

Mr. Rob Merrifield

Mr. Terry McCool

Mr. Rob Merrifield

Mr. Terry McCool

Mr. Rob Merrifield

Mr. Terry McCool

Mr. Rob Merrifield

Mr. Terry McCool

1030

Mr. Rob Merrifield

Mr. Terry McCool

Mr. Rob Merrifield

Mr. Terry McCool

Mr. Rob Merrifield

Mr. Terry McCool

Mr. Rob Merrifield

The Chair

Mr. James Lunney

Dr. Loren Grossman

Mr. James Lunney

The Chair

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

Dr. Loren Grossman

Mr. Svend Robinson

1035

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

1040

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

Ms. Julia Hill

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

1115

The Chair

1120

Mr. Rob Merrifield

The Chair

Mr. Svend Robinson

The Chair

Mr. Jeannot Castonguay

The Chair

Mr. James Lunney

The Chair

1125

Mr. James Lunney

The Chair

Ms. Raymonde Folco (Laval West, Lib.)

The Chair

Ms. Hedy Fry (Vancouver Centre, Lib.)

1130

The Chair

Ms. Hélène Scherrer

The Chair

Ms. Raymonde Folco

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

1135

The Chair

Mr. Svend Robinson

The Chair

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

1140

The Chair

Mr. Rob Merrifield

Ms. Carolyn Bennett

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

The Chair

Ms. Hedy Fry

Mr. Rob Merrifield

Ms. Hedy Fry

The Chair

Ms. Hedy Fry

1145

Mr. Rob Merrifield

Ms. Hedy Fry

The Chair

Mr. Svend Robinson

1150

Ms. Hedy Fry

Mr. Svend Robinson

Ms. Hedy Fry

Mr. Svend Robinson

Ms. Hedy Fry

Mr. Svend Robinson

Ms. Hedy Fry

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

Ms. Carolyn Bennett

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. James Lunney

1155

The Chair

Ms. Carolyn Bennett

Mr. Rob Merrifield

Ms. Carolyn Bennett

Mr. Rob Merrifield

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. Svend Robinson

The Chair

Mr. Rob Merrifield

The Chair

CANADA

Standing Committee on Health

NUMBER 031

2nd SESSION

37th PARLIAMENT

EVIDENCE

Tuesday, April 29, 2003

[Recorded by Electronic Apparatus]

¿ (0905)

[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Order, please.

Good morning, ladies and gentlemen. It's my pleasure to call to order this meeting of the Standing Committee on Health.

The Standing Committee on Health has been hearing witnesses on the issue of natural versus synthetic insulin and its impact on Canadian diabetics. We have heard from the Canadian Diabetes Association, Health Canada, and a number of individual diabetics who have been having problems with synthetic insulin.

To that end, we have invited representatives from Eli Lilly, the Canadian Diabetes Association, and Health Canada to be here today.

I would like to begin with the witnesses from Eli Lilly, please.

Mr. McCool.

Mr. Terry McCool (Vice-President, Corporate Affairs, Eli Lilly Canada Inc.): Thank you, Madam Chair. I'll make some opening comments.

We appreciate the opportunity to be able to appear before the standing committee today. My name is Terry McCool, and I'm vice-president of corporate affairs at Eli Lilly. With me is Dr. Loren Grossman, vice-president of research and development, and Dr. Carlo Di Fonzo, associate vice-president of regulatory affairs and quality compliance.

Lilly has had a long history in research and development of diabetes medications. We've been a leader in the treatment of diabetes for over 80 years, and that commitment will continue. We are proud that we were the first company to introduce animal insulin; that we were the first company to introduce human insulin; and that we were the first company to introduce rapid-acting analogs for the treatment of diabetes.

Lilly provides a portfolio of treatments for both type I and type II diabetes, and we are researching new investigative compounds for improved treatment of diabetes and also for related complications.

Today we'd like to talk about the availability of animal-sourced insulins.

I would like to turn it over to my colleague Dr. Grossman, who will discuss this in a little more detail.

Dr. Loren Grossman (Vice-President, Research and Development, Eli Lilly Canada Inc.): Thank you, Terry, ladies and gentlemen.

As Terry mentioned, I am Loren Grossman, vice-president of research and development for Eli Lilly Canada. I do have a few opening statements I'd like to make, and then I would be happy to answer any questions you may have.

Before I begin my statements, I thought it would be important to tell you a little bit about myself. I am a practising endocrinologist. I did my endocrinology training at the University of Toronto, and following that did two years of a post-graduate diabetes fellowship, at Toronto as well. After that, I spent ten years in clinical practice in a Toronto area hospital as an endocrinologist, where I was also the chief of internal medicine the last year there. I also maintained a position on faculty at the University of Toronto, teaching students and medical residents.

I left that practice in 1997 and joined Eli Lilly as their endocrinologist, and since then I have continued clinical practice and see patients with diabetes through the diabetes clinic at St. Michael's Hospital in Toronto.

As a physician and as a spokesperson for Eli Lilly, I understand that some people have difficulty when transferring from animal-source to human insulin, and who therefore need or prefer to stay on an animal-source insulin. However, there is no question regarding the safety and efficacy of human insulin. It has been proven safe and effective. It is, and has been for years, the insulin treatment of choice for patients starting on insulin, as recommended by both the Canadian Diabetes Association and the American Diabetes Association.

The biosynthetic human insulin molecule is an exact replacement of the insulin that people with diabetes are lacking. You mentioned at the beginning that this was perhaps a discussion regarding synthetic versus natural insulin; that's really not the case. Biosynthetic human insulin is exactly the same molecule as the insulin that patients with type I diabetes are lacking; it's simply made in the laboratory, as opposed to animal insulin, which comes from an animal source and is recognized by the body as a foreign protein.

Millions of people around the world are using human biosynthetic insulin, with most experiencing improved glucose control compared with that from animal-source insulin. The reported adverse events that we receive and that are also sent on to regulatory authorities around the world, including Health Canada here in Canada and the FDA in the United States, indicate that there is no difference in the reported adverse events with human biosynthetic insulin as was reported with animal-source insulin, except perhaps for immunogenic or allergic reactions, which are less with human biosynthetic insulin, because it is an exact duplicate of the human insulin versus the animal insulin, a foreign protein.

However, as I said before, I do understand that some people experience difficulty when they try to transfer from many years of using animal insulin to the human biosynthetic insulin, and therefore either prefer or need to stay on the animal-source insulin. If you would like me to do so, I can later on explain the medical reasons as to why we think this occurs.

That said, Eli Lilly and Co. remain committed to ensuring the availability of purified pork animal insulin in Canada for those patients with diabetes who need it.

We did announce on Friday that due to a markedly decreased demand, one of the three formulations of purified pork insulin, just the lente formulation, will be discontinued, since this formulation does have a time activity profile that is almost identical to one of the other formulations that will continue to be made available, the NPH.

So this announcement does not affect the availability of regular pork insulin or NPH pork insulin. We remain committed to ensuring the availability of these pork insulin products to patients with diabetes in Canada.

Those are the comments I wanted to make.

¿ (0910)

The Chair: So we have had the presentation from Eli Lilly, and I'd like to go now to the Canadian Diabetes Association and introduce to you Alexis Mantell, who is replacing the national director, Donna Lillie.

Ms. Mantell.

Ms. Alexis Mantell (Senior Manager, Strategic Communications and Media Relations, Canadian Diabetes Association): Thank you.

Donna Lillie,national director of research and professional education for the association, sends her regrets. She was unable to make it today. If you have any questions that I can't answer, I'd be happy to pass them on to Donna, and we can get back to you.

I'll take you through the Canadian Diabetes Association's position on the synthetic insulin issue. Synthetic insulins are the drug of choice for all new patients who've started on insulin therapy. Since the early 1990s, all people newly diagnosed with diabetes who require insulins are started on human insulins.

In 1998 the Canadian Diabetes Association published clinical practice guidelines for the management of diabetes in Canada. These are evidence-based guidelines that talk about the best available information regarding the prevention, diagnosis, treatment, and care of diabetes. The clinical practice guidelines state that human insulin is associated with less anti-insulin antibody formation than animal insulin, and should be used for people initiating insulin therapy.

Synthetic insulins are not harmful when used in appropriate doses. Any insulin--in fact, any drug--will be harmful if used inappropriately. Insulin needs to be used within the stated guidelines. Our guidelines note that all insulin regimens should be adapted to an individual's treatment goals, their lifestyle, their age, their general health, their motivation, and their ability to self-manage.

In addition, the association assists physicians with initiation of insulin therapy. We provide continuing education and practical diabetes management updates for physicians, for diabetes educators, and for pharmacists.

Regardless of the type of insulin used, hypoglycemia, or low blood sugar, is associated with the tighter control of blood glucose. This was documented in a diabetes control and complications trial. As you probably know, keeping one's glucose levels within a target range is very important if you're looking to prevent or delay the complications that can arise with diabetes, such as heart disease. For people with type I, it may mean multiple daily injections or the use of an insulin pump as part of an intensified diabetes management regimen.

While this trial was significant in outlining the importance of good glycemic control, it did come with the increased risk of hypoglycemia or incidents of low blood sugar. As a result, we now have a number of strategies to assist with the management of hypoglycemia and the management of hypoglycemia unawareness. Such programs include self-blood-glucose awareness training and special protocols regarding hypoglycemia unawareness.

Hypoglycemia unawareness is a phenomenon that occurs over time in people with type I diabetes, and there are many strategies to reduce the risk. Last year the association expanded our clinical practice guidelines with additional guidelines on the treatment of hypoglycemia for people with diabetes.

The guidelines lay out specific recommendations to deal with hypoglycemia unawareness. Recommendations 36(a), (b), (c), and (d) refer to the types of insulin and their relationship to hypoglycemia; look at how to identify the risk factors for severe hypoglycemia in people with type I; and list strategies for individuals who have hypoglycemia unawareness.

Synthetic human insulins do have an earlier and faster peak action than animal insulins, and management strategies should be implemented to manage such action. Insulins are available in a number of formulations that define their absorption rate, peak action, and duration. These insulin formulations are part of management treatment protocols that help to ensure all elements of diabetes management are coordinated wherever possible.

People with diabetes need to work with their physicians to understand how insulin works and how to balance their insulin injections with what they eat, their daily activities, their physical activities, and their general lifestyle.

That said, some people have difficulty using synthetic human insulin products, and should continue to have access to alternative treatments. It's always very important to recognize and give validity to individual experiences regarding insulin use. While a large majority of people do very well on human-based insulins, all practicing physicians understand there are always exceptions to a rule, and they will use their good clinical expertise to help patients solve such problems.

The Canadian Diabetes Association is concerned for the well-being of all people with diabetes, and we strongly believe there should continue to be access to alternative treatments, in this case animal insulins, as long as consumers require them.

¿ (0915)

If you're looking for some words from the association regarding this issue, we think steps should be implemented to address the withdrawal of proven therapeutics from the Canadian market. The association believes consumers should not be penalized for marketing decisions regarding therapeutics, and should not be required to take on additional financial burden to manage their conditions and receive appropriate drugs. For example, we remain concerned about the high cost of importing animal insulin products from abroad under the special access program. This cost should not be borne by individuals who require imported insulin.

In the case of animal insulins, the concept of grandfathering support for this product should be honoured until such time as consumers no longer require it.

The Canadian Diabetes Association has adopted a position on product availability and the discontinuation of diabetes medication and products. The position is this: Where a diabetes treatment option is being discontinued, people who are dependent on that option should continue to have access to that treatment or to an alternative, viable for them, without extraordinary measures, financial or otherwise, being borne by the person with diabetes; and where a pharmaceutical company declares its intent to discontinue a safe and effective diabetes product for which there is still demand, the pharmaceutical company and the federal government should work together to ensure appropriate solutions are readily available for those who find they are unable to make the transition.

Finally, I'd just like to touch on some of the actions taken to date by the Canadian Diabetes Association. As I mentioned earlier, we've reviewed the science and developed position statements regarding both insulins and hypoglycemia. We continue to offer assistance to health care professionals with any changeover protocols. We have volunteer diabetes experts and specialists who have established a network of experts, available to offer assistance to other physicians when they might have questions about their patients' use of animal or human insulins. We have communicated with industry regarding source options. We continue to communicate regularly with Eli Lilly Canada to advocate for the continued supply of pork insulin to the Canadian market. We've also communicated with consumers regarding options. We provide information about animal and human insulins on our website, diabetes.ca; through our consumer magazine, Diabetes Dialogue; and ongoing through our 1-800 diabetes information line, where people can phone with their questions. We continue to advocate to government regarding consumer access to products outside the country. We have continued to work with interested groups, such as the Society for Diabetic Rights, regarding access to animal insulin products in Canada. We continue to advocate for access to medically beneficial therapeutics, and advocate that diabetes should not be a financial burden for people with diabetes.

¿ (0920)

The Chair: Thank you, Ms. Mantell.

Ms. Allingham, did you want to add anything?

Ms. Diane Allingham (Executive Assistant, Public Policy and Government Relations, Canadian Diabetes Association): No, I have nothing more.

The Chair: Thank you.

And from the Government of Canada, Ms. Hill.

Ms. Julia Hill (Acting Director General, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Department of Health): Good morning. Thank you for the opportunity to meet with you again.

We did send a written response after the last meeting. I will not take the members' time by repeating what was in that written response, but I thought I would give you further information on steps that have been taken since then, and where we anticipate continuing with this, because this will be an ongoing relationship and discussion with both members of the diabetic community and the private sector.

I would repeat that Health Canada does believe very strongly in the importance of informed choice for consumers, and recognizes that this is indeed an issue of choice. We have met with Eli Lilly twice since our last standing committee hearing. One was directly with Eli Lilly, to have an immediate discussion with them with respect to product. That was covered in the written response that I sent to you.

We did meet again yesterday with Eli Lilly, as well as members of the Society for Diabetic Rights, Association Diabète Québec, and the Canadian Diabetes Association. There was a discussion at that point with respect to the announcement made by Lilly about withdrawal of one of the three pork products. We were also able to put on the table some of the issues and rumours that had been of concern, and I believe there was an important direct point of contact made between various individuals and, for example, Eli Lilly and Co., which had not occurred before.

We have had clarification of a variety of statements made at the June 25, 2001, meeting of the task force on insulin--that was the international federation--which underlined that there had been an announcement of a decision to withdraw one of three products, but not all three.

Eli Lilly, as they have done this morning, reconfirmed their commitment to supplying the North American market. We are satisfied for the time being that certainly all of the pieces are in place for the continued production of pork insulin. We did have a discussion about sourcing, because there was a plant or a component in Canada that had been demolished. But clearly there is a capacity to source those component parts from elsewhere in the world. We were comfortable with that information.

We have been in touch on several occasions now with CP Pharmaceuticals, the U.K. source for the beef insulin that individuals were bringing in through the special access program, to determine their interest in submitting a file to Canada for approval and marketing of beef insulin. The most recent contact was ten days ago, and to this date CP Pharmaceuticals has not informed us of a decision to seek any marketing authorization in Canada. We will continue to contact them on a periodic basis with the hope that there may be some interest for the beef insulin.

We have worked quite hard on the It's Your Health document, which was the subject of much discussion here. We took a different approach this time--namely, we developed a draft, which we sent out on March 14 to the Society for Diabetic Rights, Association Diabète Québec, and the Canadian Diabetes Association, as well as Eli Lilly, for comments. I think there is general satisfaction in the community, or certainly that's the feedback we have had, that this has come a long way from the last one. We will be reviewing this on a periodic basis.

It was our expectation that we would in fact have that published by about this week, but given the new announcement from Eli Lilly and Co. with respect to the withdrawal of product, we're just going to take another look to make sure there are no adjustments that need to be made in light of that information. But I believe It's Your Health should be out within the month, in both languages at this point.

We've also had discussions with the Canadian Medical Association, who have agreed to broaden the reference in their practice guidelines, which are currently under revision, to ensure that physicians are aware of the fact that there is animal insulin as well as synthetic insulin available as treatment options. The speed with which those guidelines are revised really lies with the Canadian Medical Association, but again, we will continue to interact with them on a regular basis on this subject.

There were a couple of questions that had been asked at the last standing committee that I didn't address in the letter. One in particular was with respect to conditions attached to Connaught, and financing for production of animal insulin. This does not fall within the purview of Health Canada but rather within Industry Canada. However, through discussions we have learned a few things.

¿ (0925)

First, we learned from Novo Nordisk, who had purchased rights from Connaught, that in 1990 the minister for Investment Canada accepted a decision by Novo Nordisk to stop supplying animal insulin when orders dropped below the threshold of 1 million vials in a 12-month period. So that was an Industry Canada decision that took place about 13 years ago. The drop of the sales occurred in 1994, and it's at that point that Novo Nordisk moved to discontinue.

I believe, Madam Chair and members, that was the one outstanding issue, but we are of course available for any further questions. I would hasten to assure not only committee members but also those who are sitting in the audience that once It's Your Health is completed, we don't consider that this is a done deal, that we're closing the book. This will be a continuing dialogue and discussion. We will remain available to members of CDA, the Society for Diabetic Rights, and any other Canadian citizen who may have concerns in this regard.

[Translation]

I would like to add that while I made my entire presentation in English, I would of course be pleased to answer your questions in French.

[English]

Thank you.

The Chair: Thank you, Ms. Hill.

Do Dr. Sharma or Mr. MacKay wish to add anything to that? All right.

Well, we called this meeting...and certainly our earlier meetings indicated that there were a lot of problems out there. From what we've heard this morning, one would think that all was well. I guess we're going to have to pursue some of these things through questioning.

We'll begin with our critic from the Canadian Alliance Party, Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): I want to thank you for coming in.

My question initially is for the Eli Lilly representatives who are here, regarding the announcement last week to eliminate the one type of insulin, I think from pork.

Is this based strictly on the fact that you have another product that will do the same job or is it based on the economics of it, of no demand? Or is it a combination?

Dr. Loren Grossman: There are a number of reasons behind that discontinuation, and I think you've alluded to most of them.

First, there's been a rapid and dramatic decline in the demand for that particular formulation. Two, there is, as you've alluded to, NPH, which has an almost identical time activity profile. In fact, irrespective of the issue of pork or human or species of insulin, endocrinologists in general have shifted away from lente toward NPH for a scientific reason. That is, as we try to optimize diabetes control over the years, we tend now to use more than one type of insulin. There are different time activity profiles--regular, as a short-acting, and more rapid-acting, to handle the immediate meal. Then people also need what's called a “basal” insulin for long-acting, throughout-the-day control.

When you mix regular insulin with NPH--which is now the trend, to mix insulins together to get more control throughout the 24-hour period--the way in which these are manufactured allows the individual components, when mixed together, to retain their individual activity profile. So when you mix regular and NPH together in the syringe and inject it, the patient will hopefully, and more likely, receive a peak activity of the regular, and then another peak of the NPH as it comes into play.

When one mixes regular with lente, because of the way they're made the peaks tend to meld together. So instead of maintaining the individuality of the combined insulins, they tend to sort of form one peak in between the two, and that's not as optimal control as we'd like. Regardless of the issue of species, endocrinologists have been shifting away from lente and into NPH, when mixing with regular insulin, to more aggressively get control of patients with diabetes.

So there are many reasons behind this decision.

¿ (0930)

Mr. Rob Merrifield: I was just trying to get to whether it was a health reason or whether it was a financial reason. The problem is, the people out there who are buying this, or the ones who have been in my office talking about it, are used to a certain type of pork insulin or beef insulin. They've been using it for a significant period of time and have had great success with it, and feel a great amount of fear in having to change to a different type of insulin.

Dr. Loren Grossman: Yes. This doesn't change species, and as I mentioned before, there are some people who have clearly had difficulties when switching from an animal insulin to a human insulin. This will not involve that. This is still pork insulin. When switching from lente insulin to NPH insulin, obviously patients who are taking insulin will have to do that with the guidance of their health care professionals, their physicians, diabetes nurses, educators, etc., because there may need to be some adjustments of the dose or the timing of the injection. There will be some potentially slight differences, although, as I said, the activity profile is almost identical.

So people should not be doing this on their own, but the switch can be made. I mean, in medicine you can never say never, and never say always, but the switch can be made quite well, almost always, with the guidance of a properly trained diabetes health care professional.

Mr. Rob Merrifield: I think probably...and I'm just reading into what I sense is the situation. If you're prepared to drop this insulin, would there in the foreseeable future be a situation that would arise that would allow you to drop, or make you consider dropping, all of the pork and beef insulins and the manufacturing of them? I understand you're the only company that is providing that right now.

Dr. Loren Grossman: We're not providing beef or mixed pork-beef insulin any longer. No one is in North America. But as I said before, we are committed to ensuring that pork insulin remains available in Canada. So there are no plans to discontinue the availability of the regular pork insulin or the NPH pork insulin.

Mr. Rob Merrifield: For the foreseeable future, but....

Dr. Loren Grossman: No plans at all.

Mr. Rob Merrifield: Okay.

Now, are you getting the same sorts of lobbies and concerns in the United States and in other countries on the availability of pork insulins?

Dr. Loren Grossman: No.

Mr. Rob Merrifield: It's available and they're aware of it?

Dr. Loren Grossman: It's the same situation. We're the only company that supplies animal insulin in North America.

Mr. Rob Merrifield: Then my next question is to Health Canada.

You say that you've talked to the Canadian Medical Association with regard to the availability of pork insulin. I guess my concern is that when you talk to diabetics, they say their doctors weren't even aware that it was available any more. So is just talking to the Medical Association really doing the job of informing the general practitioner on the availability and the potential assets of the product of pork insulin?

Ms. Julia Hill: I apologize, perhaps my remarks were not clear. The purpose of speaking to the Canadian Medical Association is that they are currently revising their practice guidelines with respect to diabetes treatment. The concern that had been raised, we had heard, as you had, was that physicians were perhaps no longer aware that there was such a thing as pork insulin as a treatment.

The discussion with the Canadian Medical Association, therefore, is that in their new treatment guidelines they will very clearly indicate the possibility of pork insulin as well as synthetic insulin for treatment, and we are anticipating that will help further educate physicians that these are in fact two things they could be considering for their patients.

We have also initiated some discussion with the Canadian Pharmacists Association, because we had heard as well that there was a lack of awareness there. But we haven't had much feedback there yet, so we'll continue working.

Our object in engaging in discussion with the professional associations is to raise awareness and to make sure that somehow that's anchored in documentation that they send out themselves.

Mr. Rob Merrifield: And I applaud you for doing that, although it may be a little late.

My fear is that just giving it to the association is not enough. They could take it and put in file 13, or they could take it and apply it and really try to inform their association. But when I talk to general practitioners about their relationship with the Canadian Medical Association, sometimes they feel very alienated from that association as well. So I'm not sure it's really going to do the job.

As well, a lot of the marketing happens from the pharmaceuticals directly to the practitioners. That's my concern.

¿ (0935)

Ms. Julia Hill: We can certainly continue to explore ways to pursue that. There are some practical limitations with respect to our mandate. For example, from a regulatory perspective, Health Canada is not involved in the training of physicians in academic institutions. That said, there are nonetheless ways in which we can seek to influence, and we'll continue to do that.

Mr. Rob Merrifield: That takes me to the other question. With regard to your It's Your Health pamphlet, which we saw last time, you said that you've switched it up, and changed it somehow. It would have been nice to see it. Can you tell us how you've changed it? Just highlight the changes.

Ms. Julia Hill: There was a perception that the first one appeared to be quite defensive with respect to the safety of human insulin, and the focus was very much on human insulin. Again, what we understood when we woke up and smelled the coffee was that there really wasn't enough clear and balanced messaging about the safety of both products and the importance of choice so that diabetic patients may choose either synthetic insulin or pork insulin.

So the new It's Your Health talks about diabetes generally, talks about the safety and availability of both types of products, and underlines some of the messaging with respect to consulting with physicians when there are problems with ensuring regular treatment. The main shift in focus is that it does include animal insulin as a potential treatment option.

Mr. Rob Merrifield: Okay.

The doctor had some response.

Dr. Loren Grossman: Just in follow-up to your question or comment about notifying physicians so that they are aware of this, we have a website that lists all available insulin products, including pork insulin products. The Canadian Diabetes Association publishes their physician newsletter, Diabetes Dialogue, and one issue every year lists all diabetes products available in Canada, which includes our pork insulin products.

Furthermore, with the announcement of the discontinuation of that one formulation of lente, on Friday we at Lilly Canada faxed out letters to all physicians, all diabetes nurse educators, and all pharmacists indicating the discontinuation of the lente formulation and indicating the continued availability of the other two pork products.

As well, we offered to the pharmacists a letter--as a company we can't have direct patient records, but they as pharmacists do have records of which of their customers are using pork insulin--that they could give to the patients who are using pork insulin, to notify them as well.

The Chair: Thank you, Mr. Merrifield.

Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair. I would like to thank our witnesses as well.

We were talking about education and the importance of ensuring that doctors are aware that animal insulin exist.

Are future doctors still being taught in medical school that animal insulin is a treatment option in some cases? I believe it is perhaps the starting point, after all. That is where we may have to ensure that medical students are getting the information, before they reach the labour market, rather than trying to inform them later.

If I understand correctly, you are involved in education. Could you tell us whether this information is being provided in medical schools?

Secondly, we often hear from people who wanted animal insulin, and they complain about the famous hypoglycemia unawareness. In your experience, in your practice, have you had any patients who had these problems?

Finally, did you have to switch to animal insulin for any of the new diabetics you had started to treat using synthetic insulin?

[English]

Dr. Loren Grossman: Three questions; I'll try to address them for you.

Unfortunately, I can't comment on the first question. I'm not aware of the current content of the faculties of medicine across the country at the various universities. Historically, it's interesting to discuss this information, and if I myself were giving lectures on diabetes management and insulins, I would certainly talk about it and say they're still available. I would talk about the historical importance of animal insulins.

But again, I can't comment on what is being taught at other faculties.

¿ (0940)

Mr. Jeannot Castonguay: But do you think it should be taught in the faculties?

Dr. Loren Grossman: I think it's important from an historical perspective, that there are some people, as I mentioned, who are having difficulty in switching. Again, in the interests of informing students about all of the possible options, it's important to mention it, absolutely.

I'm not sure I understood the second question regarding hypoglycemia with the insulins.

Mr. Jeannot Castonguay: Some patients complain that when they are on synthetic insulin, all of a sudden they have hypoglycemia, and they don't feel it coming. They say that when they were on animal insulin, they could feel the symptoms coming.

That's been a big complaint I've received from many of the constituents in my riding.

Dr. Loren Grossman: That's a big issue. Let me try to tackle that.

You're referring to the phenomenon of hypoglycemia unawareness. Most people, when they develop hypoglycemia or low sugar, can sense it. They feel shaky, sweaty, and trembly. There is a phenomenon of hypoglycemia unawareness where some people will not notice these symptoms, and they suddenly just go into the second stage, which is unconsciousness, or a fugue-like state, or decreased level of consciousness.

Back in the late 1980s, when human insulin first became available on the markets, there were some case reports of people experiencing hypoglycemia unawareness when they switched from animal insulin to human insulin. There was a concern then, from these case reports, that maybe human insulin somehow exacerbates or causes this problem.

As a result of these reports, a number of scientists around the world started to do properly controlled studies to look at this, to see whether this phenomenon really was a result of the species or some other factors. Case reports obviously have lots of biases; you're not controlling for other potential causes.

So they did carefully controlled studies to look at this, and all of the studies concluded that the source of the insulin is not a factor in hypoglycemia unawareness. Hypoglycemia unawareness has been reported, and was reported, well before the availability of human insulin on the market. It occurs with animal-source insulin. There are factors that are responsible for a person to be more likely to have hypoglycemia unawareness, and they include the duration of diabetes. So the longer a person has diabetes the more likely they will have this.

This is probably related to what is called an “autonomic neuropathy”. With long-standing diabetes one of the complications is nerve damage, and if the nerves involved are the so-called autonomic or automatic nerves, which can control these symptoms and the release of other hormones to counteract the hypoglycemia, that can be lost with long-standing diabetes, 15 years of it. So somebody with longer-standing diabetes with this autonomic neuropathy will lose those symptoms.

Another factor is the frequency with which they have had hypoglycemia in the past. Somebody who gets frequent hypoglycemia will eventually lose the symptoms and develop this hypoglycemia unawareness. A number of studies have shown that there are more and more people who are probably having overnight hypoglycemia--unaware of it because they were sleeping--and because of these repeated episodes of low blood sugar were then developing this hypoglycemia unawareness. When these people were controlled, and their overnight hypoglycemia reversed, their symptoms came back.

Subsequent to these early reports, then, it's been clearly shown that the species of insulin has nothing to do with this. It occurs with equal frequency with both animal and human insulin, and has to do with other factors related to diabetes.

Mr. Jeannot Castonguay: Am I to conclude that if you switch them back on animal insulin they will have the same problem of hypoglycemia unawareness?

Dr. Loren Grossman: That's a different phenomenon. As I said earlier, there are reasons why we think that people who are on animal insulin, when they switch to human insulin, have problems. The reason is that animal insulin is a foreign protein. And there are differences; insulins are proteins, they're made up of amino acids.

Beef insulin has three different amino acids from human insulin. Pork insulin has one different amino acid from human insulin. Because these are foreign proteins, they are recognized by the body as being foreign substances, and the body develops antibodies to them. These antibodies with animal insulin change the time activity profile in some people. They bind the insulin, release it more slowly from the subcutaneous injection site, and instead of seeing, for example, with regular insulin, a peak at three to four hours, it delays things.

As a consequence of that, people who have been on animal insulin for a long time adjust the dose and timing of their insulin regimen to account for this antibody response.

When human insulin became available and people started switching, the human insulin then was an exact replica, exact duplicate, of their own natural human insulin. The body didn't recognize it as a foreign substance, and the antibodies didn't have this reaction. Suddenly it started working much faster. People weren't prepared for this, and started dropping their sugars very quickly. So adjustments needed to be made in the timing of the dose and the amount of the insulin to account for this antibody difference. This is likely the reason why, when people switched from animal to human, there were increased reports early on of hypoglycemia.

As well, people who have switched from animal to human have told me that the feelings they get are different. They get a different feeling when they have hypoglycemia with human insulin compared with animal.

So a number of different factors are at play here.

¿ (0945)

Mr. Jeannot Castonguay: So are you telling me we should be able to adjust the synthetic human insulin with a different dosage, and the time of the injection? Surely we don't have that problem.

Dr. Loren Grossman: In many but not all cases, people who switched from animal insulin to human insulin, when they were under very careful supervision, were able to make that switch and make those adjustments. But as I said, there are some people, for reasons I can't explain, because I don't know individual cases, who have not been able to do so. Maybe there are differences in their antibody responses. Maybe there are unpredictable, different antibodies we don't know about.

Most people have been able to make the switch by adjusting the dosage. Some have not been able to.

Mr. Jeannot Castonguay: My last question is, do you have patients in your practice that you started on human synthetic insulin and then, because of problems, you had to put them on animal insulin and they did better?

Dr. Loren Grossman: No.

Mr. Jeannot Castonguay: Okay, fine.

Thank you.

The Chair: Mr. Spencer.

Mr. Larry Spencer (Regina—Lumsden—Lake Centre, Canadian Alliance): Thank you, Madam Chair.

That's basically the same area that I was going to go into. I've heard of a number of people who were on NPH for a period of time and who began to lose awareness of the hypoglycemic experience.

You mentioned the fact that if they have that experience frequently, it does damage to the mechanism that allows us to be aware of that. I have personal experience with that. I've been on this about ten years, and I could give you the numbers at which I used to notice those symptoms. I now can go below those.

Number one, how frequent a hypoglycemic experience are you talking about when you say that this can become damaging? As well, and I think maybe the last question over here was the same as this one, do people then switch back from humulin to the pork in order to have a better awareness?

Dr. Loren Grossman: I'm not sure I can answer your first question with specifics. I'd have to go back to the literature and see the frequency, the exact number of how frequent, but one of the factors that has been identified as a factor responsible for resulting in hypoglycemia unawareness is previous hypoglycemia. So the more hypoglycemic episodes someone has had previously, either experienced or unexperienced, if it was overnight, will lead somebody to lose those symptoms. As to the exact number, I'd have to check the literature.

On the other question, yes, there clearly are people who, as I mentioned, have had difficulty when switching from animal insulin to human insulin because of this phenomenon. They haven't been able to make the adjustments in the timing or the dosing, and continue to have problems. They have told us that when they switch back to the animal insulin, they feel better.

So clearly that does exist, but that's somebody who has been on animal, who tried to switch to human, and, for the various reasons that are probably not clear to us, were not able to do so. They switch back, and go back to their previous state, which was--

Mr. Larry Spencer: No, my thought and question was that for someone like me, who started on the humulin, and for whom the awareness factor decreased, do they then move to the pork insulin and have any better results?

¿ (0950)

Dr. Loren Grossman: I'm not sure if that specifically has been studied, but I know from the literature that when the factors that were identified, such as previous hypoglycemia, were reversed... One paper in particular showed that people were having hypoglycemia when they slept, and obviously weren't aware of it, as a cause or as a factor responsible for their hypoglycemia unawareness. When those factors were reversed, when that was prevented, their symptoms came back.

I'm not aware of literature where people who had never been on animal insulin and were having hypoglycemia unawareness were switched from human to animal to see if that reversed it. As I said, all of the studies have concluded that the species of insulin is not a factor in the development of hypoglycemia unawareness. I have a stack of papers on my desk that come to the same conclusions, from early 1990 reputable journals.

Mr. Larry Spencer: Thank you.

The Chair: Madame Scherrer.

[Translation]

Ms. Hélène Scherrer (Louis-Hébert, Lib.): Thank you, Madam Chair.

I would just like to be sure I understand the scope of the problem we're discussing today and see how many people are affected by this, and in what way. I have a few very brief questions for you.

You refer to a percentage of diabetes patients. How many such patients are there in total? And what type of health problems are we talking about? It seems that today we are discussing problems patients have adapting to a new treatment. Are we just talking about discomfort, or are we talking about problems that could be very serious and even produce a very poor quality of life? Are these patients going to die? I would just like to know more about the scope of the problem we are discussing here.

Third, we have been talking about patients who switch from one treatment to the other, who seem to change treatments. Since human insulin will no longer be available, as of now, will all patients be started off on a synthetic insulin?

[English]

Dr. Loren Grossman: I'm not clear on the first question you asked me. What percentage of patients are affected by what? I'm sorry.

Ms. Hélène Scherrer: Simply, what percentage of people cannot switch from one to the other? How many people is it, how many patients? What's the number?

Dr. Loren Grossman: That I don't know. Obviously, it's based on people who go to their physician and report that they can't do it. I don't know. It's a small number, but I don't know the exact number.

Ms. Hélène Scherrer: So we don't know how many people are affected by that decision, for example, or how many patients will suffer from the fact that you're not producing the....

Dr. Loren Grossman: Okay, that's different. We are still producing pork insulin. So the issues--

Ms. Hélène Scherrer: How many people are having problems switching from one to the other?

Dr. Loren Grossman: From pork insulin to human insulin?

Ms. Hélène Scherrer: Yes.

Dr. Loren Grossman: I don't know. It's a small number. I don't know that. But we are continuing to produce pork insulin. This announcement of discontinuing only one formulation does not prevent people from continuing on the animal insulin they need.

You asked about the kinds of problems. The people who have had difficulty in switching from animal insulin to human insulin have major problems. They have hypoglycemia unawareness. There are unpredictable drops in their blood glucose levels because of the loss of this antibody binding. These people do have serious problems. They can drop their sugars quickly, and that can result in a seizure or coma. So these are serious problems for these people who have not been able to make the switch.

And I'm not sure of the third question.

Ms. Hélène Scherrer: I'm going to go back to the first one anyway. We're talking about 400 Canadians who are affected; they still need animal insulin.

Dr. Loren Grossman: Yes, that's approximately--

Ms. Hélène Scherrer: Does that mean those 400 Canadian might die?

Dr. Loren Grossman: No. Let me explain.

Our estimates are that about 320,000 Canadians use insulin. Of that, about 0.1% are likely using animal insulin. Now, those figures are based on purchases from the pharmacy.

We also know that people buy animal insulin for their pets. Cats and dogs get diabetes and people buy animal insulin, particularly for the cats. So of those 0.1%, which is about 320 or so, we don't know how many are actually for the pets. It's less than 300.

Those people will still have pork insulin available. We are not discontinuing the pork insulin they need. It's just the one formulation, which can be transferred over from the lente to the NPH; they are almost identical.

So will they die? No.

¿ (0955)

[Translation]

Ms. Hélène Scherrer: Will people who really need the formulation you are discontinuing be able to get it somewhere else in the world?

[English]

Dr. Loren Grossman: The lente pork insulin is not available from anyone else, as far as I'm aware of, in North America. There are other manufacturers of animal insulin in Europe and Asia and other parts of the world.

The Chair: Thank you, Madame Scherrer.

Mr. Lunney.

Mr. Svend Robinson (Burnaby—Douglas, NDP): Sorry, Madam Chair, could I just get clarification on the order of questions? There have been three Canadian Alliance questioners. I'm not trying to be difficult here, but I understood there was an order that was agreed to.

The Chair: Well, we haven't passed that motion yet because we haven't had quorum, Mr. Robinson. We still don't today have quorum to pass the motion on the system that we agreed to at a meeting about two weeks ago.

Mr. Svend Robinson: Go ahead. It's just a rather bizarre alternate--

The Chair: Yes, I know you feel that a lot of things here are bizarre. Nonetheless, it is at the call of the chair, and Mr. Lunney will speak next.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Thank you very much, Madam Chair.

For the first question, I want to go back to the notice of discontinuation of the lente product, which just went out, I understand, in the last week. How many people are actually affected by having to switch their products? How many people are you selling this lente product to right now?

Dr. Loren Grossman: In North America it's estimated at about 500. This is in Canada and the U.S. Again, that's going to be including people who are buying this for their pets. So we have to make rough estimates based on populations, and we estimate around 40 to 50 purchases, again, in Canada. How many of those are for pets? We don't know.

Mr. James Lunney: Okay, that clarifies that aspect.

We've had some discussion about hypoglycemic unawareness. The people who came to us with very big concerns about this claimed...and I think this was covered a little bit here with Madame Scherrer's questions about the fast-acting nature of the humulin, and how many of these people are just dropping, as they were not used to doing with their animal-based insulin.

So you're certainly not denying that there have been some very severe problems, for a small segment of the population, with the humulin-type products.

Dr. Loren Grossman: I'm not denying that some people who tried to switch from animal insulin to human biosynthetic insulin had difficulty in doing so. Don't forget, prior to human biosynthetic insulin coming on the market, everyone who was on insulin was taking animal insulin. Nowadays, 99.9% of people who take insulin take human insulin, and many of those were switches. Most people were able to switch under careful and proper supervision, safely, to the benefit of their diabetes control. There is a small group that has been unable to do so.

So I'm not denying that there is a small group that has been unable to make that switch.

Mr. James Lunney: We understand that there have been some six to eight deaths related to the switch. Can you confirm that?

Dr. Loren Grossman: I can't confirm or comment. I don't have that specific information.

Mr. James Lunney: Okay.

We had parents here, who actually visited most of us, with pictures of their young ones, mostly teenagers, who had devastating results with the switch. In fact, there were at least six or eight recorded deaths.

Perhaps Health Canada can comment on that.

Dr. Loren Grossman: There's no question that diabetes is a devastating disease. I think the public has become a little bit complacent in thinking that we now have insulin, and therefore all people with diabetes have to do is take insulin, and they're all cured. That's unfortunately not the case. It's a terrible disease. It has terrible long-term complications. The medications are helping, and there have certainly been advancements in the medication, but we certainly are nowhere near a cure, or nowhere near getting people back to a situation where they don't have to worry about their disease.

Unfortunately, people with diabetes will succumb to their disease or to the way in which they manage their disease. It happened with animal insulin as well. There are people who unfortunately die because of hypoglycemia, and they did so when they were taking animal insulin as well.

It's important to realize the overall picture and put this in perspective.

Mr. James Lunney: With all respect, Doctor, we're not talking about chronic, degenerative diseases, or factors related to long-term diabetes. We're talking about very sudden and catastrophic death among young people.

Dr. Loren Grossman: Well, I would challenge that statement, because a lot of research has been done looking into these so-called sudden death syndromes. In many cases, the literature suggests that the people who had this condition had long-standing diabetes. They likely had some difficulties, perhaps with their heart. Because of the diabetes, they may have been more prone to dysrhythmias or other conditions...which the hypogylcemia, in an otherwise healthier person, wouldn't have had a problem with. Their underlying diabetes exacerbated the problem.

So I don't think we can make that claim.

À (1000)

Mr. James Lunney: So you're denying that there's any relation of young people in particular with the switch to synthetic insulin? It's young people who have died as opposed to old people, from complications--

Dr. Loren Grossman: I didn't say young or old. People can be young and still have had diabetes for many years and had complications.

Mr. James Lunney: Health Canada...?

Ms. Julia Hill: If I may, I'll ask Dr. Sharma to speak a little bit about the data we do have on adverse drug reactions.

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, in terms of what we do, there's a repository for adverse event information in Canada through the adverse drug reaction monitoring program. We collect adverse reactions that are submitted either by health care professionals or consumers, and those are put into the repository.

When you look at the two groups of insulin products, it's a little bit difficult to compare, because you have different patient populations who are using different numbers. But when you look at them and the overall pattern, there doesn't really seem to be an overall difference in pattern in terms of hypoglycemic events and seriousness of events.

Absolutely, there are people who, on different forms of insulin, have more severe reactions than others, but when you look at the two groups, they usually end up balancing out.

I think what people are concerned about is that there is a group of patients who do have difficulty sensing those symptoms of low blood sugars. With diabetes, as Dr. Grossman has pointed out, it's very difficult, because there are many different reasons for low blood sugars. But we do have reports of people who have maintained very steady insulin levels, have maintained their diet, have maintained their same level of exercise, and yet still have difficulty sensing that. They are a small group, but we want to make sure that those people are heard.

When you have an event that's rare, often you will use broad-brush strokes and say, okay, overall the insulins are absolutely identical, or they should be the same. Really, though, it comes down the practice of medicine, to the individual patient you have in your office, and deciding what medication best suits them.

So overall, we can say that there really isn't a difference in terms of the adverse event profiles, in terms of the numbers of hypoglycemic events that people have, and overall glucose control. Ultimately, you have to look at the patient in front of you and make that individual decision.

Mr. James Lunney: Are you aware of adverse effects leading to death with a switch to synthetic insulin?

Dr. Supriya Sharma: Not specifically. The event information we get has different levels of detail on it. We do have reports of people who have described a severe hypoglycemic event, and a hypoglycemic event seems to have led to death in patients who have switched. We do have that.

We also have cases where death has been reported as an adverse event outcome, but it's difficult to actually tease out, from the information we have, whether that's a direct relationship.

Mr. James Lunney: Thank you.

To the Canadian Diabetic Association, one last question. With regard to practice guidelines, you mentioned information on management, prevention, and so on, which is available in your position paper. Does the association have a position on the importance of dietary chromium, for chromium supplementation with regard to the glucose tolerance factor, or the importance of dietary chromium in managing blood sugar?

Ms. Alexis Mantell: .No, I don't think we do. I don't believe it's in our current guidelines. Those guidelines are under review, and we will have a revised set of guidelines this fall. I can check into your question in more detail, but I believe it's no.

Mr. James Lunney: We seemed to get a reaction from Dr. Grossman here.

It doesn't ring well with you?

Dr. Loren Grossman: I'm curious as to why you asked that question.

Mr. James Lunney: Oh, there's ample information, according to the information I've seen in the medical literature, that chromium is absolutely essential for the glucose tolerance factor. In a society that consumes a lot of sugar, it's therefore a very important consideration in the prevention.

Dr. Loren Grossman: Yes. This has been an allegation for many years. I think it's been well studied. There were some earlier reports that suggested that people with diabetes were deficient in chromium. As you mentioned, chromium in high amounts can interfere with insulin kinetics; however, there have been studies, looking at chromium supplementation and diabetes, showing no effect whatsoever.

I sat on the national nutrition committee of the Canadian Diabetes Association many years ago. We looked at this...and no scientific basis for recommending chromium supplementation, or not, for people with diabetes.

Mr. James Lunney: So you would deny that it is a subject of discussion? Certainly there is a lot of information available on the effect of chromium, and vanadium, for that matter--

Dr. Loren Grossman: No, I don't deny those at all. We discussed it today, and I said there's lots of literature on that, but there's no scientific evidence to suggest that chromium supplementation is of any benefit to people with diabetes.

À (1005)

Mr. James Lunney: We're talking about prevention now, early stages, and blood sugar metabolism.

Dr. Loren Grossman: I see. No, I'm not aware of any scientific literature suggesting that chromium supplementation will prevent diabetes.

Mr. James Lunney: Thank you.

If the Diabetic Association has an opinion on that, I'd appreciate it if you provided that for us.

The Chair: Mr. Robinson.

Mr. Svend Robinson: Thanks very much, Madam Chair.

I regret that I wasn't able to be here for the early evidence, but I did want to ask a number of questions that partly arise from the answers I've heard.

I have to say, I was deeply disturbed by the discussion around numbers. I mean, we're dealing with human beings here. And whether it's 0.1% or whether it's 1% or whether it's 40 or 50 people, we're dealing with human beings. It seems to me the critical issue here is that for those folks who do need animal insulin they have a secure and safe and ongoing supply.

Frankly, I was appalled that Eli Lilly decided to withdraw one of the forms of animal insulin. I'm sure there were corporate reasons for doing that, and we know that in this area, obviously it's corporate profit that drives your decisions.

I guess I look to Health Canada for leadership. I'm new as health critic. My predecessor, Judy Wasylycia-Leis, worked on this issue for many years. But the more I look into this, the more I have a sense of a complete failure of leadership by Health Canada on this issue. I want to put that very directly to the representative from Health Canada, if I may, in a couple of specific areas.

I understand that as long ago as 1995, the American Food and Drug Administration reported that humulin was the eighth-most-reported drug for adverse reactions in the United States. That's very serious.

I want to ask the Health Canada representatives here, did you receive that information? Were you aware of that information? And if so, what steps did you take to act on that, to ensure that Canadian diabetics and health care professionals were aware of it as well?

Ms. Julia Hill: Thank you for your question, Mr. Robinson.

I'm going to ask my colleague Dr. Sharma to speak specifically about the adverse drug reaction, but I'd just like to back up a little bit. Both synthetic insulin and animal insulin have been provided marketing authorization by Health Canada on the basis that in each instance the benefits of the products outweigh the risks. We are very careful to always put our product evaluation process within the context of risk benefit.

In most instances, certainly when we are talking about diabetes, we're talking about a very serious illness that has significant consequences. Regardless of the numbers of people, these are people's children, these are people's parents, and we're very aware of that.

The risk-benefit profile, therefore, of both products are such that the benefits outweigh the risks, but there are always risks. We do track that through our adverse drug reaction database. Dr. Sharma can speak a little bit more about the interchange of information not only with the USFDA but also with other sources of information internationally.

Part of the product evaluation process, however, also requires that the scientists go to a variety of databases and seek out information about the safety profile of these products. That information is taken into consideration.

Mr. Svend Robinson: With respect, I asked a specific question about the American advisory.

Dr. Supriya Sharma: Specifically to the advisory, when you look at those numbers, they're actually absolute numbers on overall numbers of reports that were sent in. You'd have to look at those reports and those numbers, and the products quoted, in the context of how many people were taking it, how many doses we're dealing with, and what the patient exposure is overall.

So an absolute number of adverse event reports does not necessarily mean that number seven has a more severe adverse event profile than number eight. You really have to take a look at it in the context of how many patients are taking it, what those adverse events were, what the severity was, and especially--

Mr. Svend Robinson: But given those 1995 numbers, didn't some warning bells go off?

Dr. Supriya Sharma: In terms of...?

Mr. Svend Robinson: In terms of the fact that it was the eighth-most-reported drug.

Dr. Supriya Sharma: In terms of the insulin issue, we've been looking into the insulin issue from the point of scientific medical literature, adverse event reports, and other scanning. We have regular communication with the FDA through videoconferences, in addition to other international groups. So our interest and our investigation of the issue of insulin predated that report.

À (1010)

Mr. Svend Robinson: But what I'm asking is, did you do anything to follow up on that specific report?

Dr. Supriya Sharma: When we looked at that report? Yes, actually, we have a scanning process that looks at not only those reports but if there's anything else, for instance, on insulin that comes out of the medical literature, or if there's any other regulatory authority that puts out other information. That is then assessed as part of whatever examination we're doing.

Mr. Svend Robinson: And what do you do with that assessment? Was there any communication with the medical community in Canada on that expressly?

Dr. Supriya Sharma: Specifically on that?

Mr. Svend Robinson: Exactly.

Dr. Supriya Sharma: When we looked at the numbers they were dealing with, and the information that was presented, it didn't change anything in terms of the safety profile, or it didn't change anything in terms of the recommendations we were putting out at the time.

Mr. Svend Robinson: Now, as I understand it, a recent Cochrane review came to some pretty disturbing conclusions. I understand that Health Canada officials have said that the Cochrane evaluation was a good evaluation. Here's part of what they found:

Though many studies were of a randomised, double-blind design, most studies were of poor methodological quality....Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human [insulin] might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety.

Now, given those conclusions of the Cochrane review, those are pretty serious condemnations of this whole process. I wonder what conclusions Health Canada would draw from this about the safety of biosynthetic insulin given the fact that it seems that the trials had some pretty serious flaws. And I'd ask Eli Lilly the same question.

Ms. Julia Hill: I will answer first, then. Again, the benefits of the product outweigh the risks. When we compare the adverse drug reactions and the concerns around synthetic insulin with those around animal insulin, on balance we have the same issues for both. The majority of diabetic Canadians manage quite well, from the information we have, on the synthetic insulin.

We are--

Mr. Svend Robinson: Do you accept the conclusions of the Cochrane review?

Ms. Julia Hill: We have accepted that the methodology is excellent--I think, Dr. Sharma, you looked into that a little bit more--but it did not change the outcome that synthetic insulin is a life-saving, life-maintaining product for many diabetics in Canada. So there was discussion earlier on about the safety profile, whether it should be withdrawn. This was looked at. Very clearly, that would create huge problems in the diabetic community in Canada.

Mr. Svend Robinson: Ms. Hill, the Cochrane review said that the studies were lousy studies, of poor methodological quality, with many key outcomes that weren't examined. If those studies weren't satisfactory, where's the leadership of Health Canada to make sure that proper studies in fact are conducted, since we're talking about the health of Canadians? Where's your leadership on this? These studies weren't good. What are you doing to make sure proper studies are done?

Ms. Julia Hill: Dr. Sharma, can you comment on the Cochrane study?

Dr. Supriya Sharma: Overall, just for the benefit of members, the Cochrane review is a methodology to look at different medical studies that are in the literature, and that tries to offer a way to compare them in some sort of way that makes sense, where you can put one beside another and be able to draw some conclusions. The focus of the Cochrane review was actually on hypoglycemic events. That's what they were looking at as their primary outcomes. So they were looking at hypoglycemic events, insulin dosage, level of fasting, and glucose levels, and their primary conclusion was that there was no difference between the two groups.

In their commentary, they also said that a variety of different parameters, when they looked at the literature, weren't done well. Classically, one of the things not necessarily focused on as much as we should do in medical literature involves qualitative outcomes, the patient quality of life issues. I think they have focused a bit on that.

You know, we're in agreement that the studies that have been done looking at those specifics may not have been to their standards. I mean, if you were doing a separate Cochrane review saying, “Let me look at all the insulins, and let me see what we can conclude about quality of life”, we'd probably look at them and say, “Well, it's really difficult.”

Mr. Svend Robinson: So what are you doing to make sure proper studies in fact are conducted?

Dr. Supriya Sharma: I will have to turn that back to the clinical trials group.

Ms. Julia Hill: Our responsibility and mandate is to assess the risks and benefits of products that come to us, using the scientific data that we have received. And that's not referring necessarily to the detailed level of quality of life, to which you referred, but the safety of the product, or the benefit against the risk to a person with diabetes. When we review the product, be it animal or synthetic or any other product, we come to a conclusion that either the risks are too great, and therefore the product is not given market authorization, or yes, there are risks but the benefits outweigh them. It therefore has to be addressed through labelling, perhaps, the product monograph, or a variety of other ways to signal that there are some risks associated with this product.

That is what we have done and what we continue to do. If we have a significant issue--adverse drug event reports, for example--that is looked at. There are decisions on occasion, not infrequently, to withdraw products if it really does represent such a risk to the public with new information.

That is not the case with any of the insulins. Our concern right now is to ensure that there is choice available to patients. There are those who very strongly prefer synthetic insulin. There are those who clearly require the animal insulin. So that is the focus of our efforts at the moment.

À (1015)

Mr. Svend Robinson: Does Eli Lilly want to respond on the Cochrane review?

Dr. Loren Grossman: I haven't read the full Cochrane review, so I can't make detailed comments, but you keep quoting this one statement about the studies being poorly done. I'd like to know, which studies are they referring to? Which studies are you referring to?

It's my understanding that the Cochrane group specifically looks at quality of life issues with respect to medications and health economics. We're talking here about safety and efficacy. So which studies are you referring to that were not done properly, the safety and efficacy studies or the quality of life studies? There's a big difference.

Mr. Svend Robinson: The Cochrane review didn't look at just qualify of life. Among other things, they looked at diabetes complications and mortality. It sounds pretty basic to me.

Dr. Loren Grossman: It depends on which studies they're referring to.

Mr. Svend Robinson: That's what they're referring to.

Dr. Loren Grossman: There are many different types of studies, and studies don't always tell the whole story, as well. As you know, after studies are done and marketed products are on the market, and adverse drug reports come in to the regulatory authorities around the world, with post-marketing surveillance...which is vast in numbers, and outweighs any of the numbers that occur in any study.

Again, looking at the safety of a medication, the post-marketing surveillance data, which is now decades old, on thousands and thousands of patients, is reviewed by regulatory authorities around the world. That would clearly indicate any potential trend, far above and beyond any smaller-scale studies, which have clearly shown no safety issue, as Ms. Hill has eloquently--

Mr. Svend Robinson: I'll come back to this on a second round, if I may, Madam Chair. I know my time is up.

The Chair: I'd like to get in on this now, if I may.

You've alluded to several studies, Dr. Grossman. You said “all the studies”, that you have “piles of studies”. I'd like to have a list of those studies to know where they were conducted and to know who paid for them.

Dr. Loren Grossman: Are you referring to the studies I mentioned regarding the factors responsible for hypoglycemia unawareness?

The Chair: It was to do with.... Essentially, you were claiming that these things happen with both animal and synthetic insulin. You said you had studies--and I think you put your hand about this high on your desk--that proved there was no difference. So my question is, who paid for those studies? What are those studies? Could you send us a list of them? I don't know whether you have time to find out, or if somebody could tell you, who paid for them. Because if they were paid for by the manufacturers of synthetic insulin, that raises questions in my mind. If they were done in university labs, out of, say, government research funds, that's a different story. So that's one question.

The second thing is that you said 99% of Canadians take synthetic insulin, and the implication is that they choose to. That could be a function of just the excellent marketing you have done among the physicians, or it could be the fact that when synthetic insulin was introduced it was much cheaper. So it could be the price factor at the day of introduction. It could be that some provinces pay for this and they've only listed it on their formulary as the synthetic insulin, as opposed to the other. There could be a variety of reasons.

I wouldn't want to leave it in the air that 99% of Canadians say, “Oh, which insulin will I take?”, and happen to pick synthetic.

Dr. Loren Grossman: None of the three examples you have provided us with gives the reason why most Canadians use human biosynthetic insulin.

Number one, I believe--and this is going back to the eighties--the price was probably higher when human insulin was introduced compared with animal. But I'd have to check on that.

Number two, I actually take exception to the fact that someone would suggest that a physician would be influenced by the marketing of various pharmaceuticals. I am a practicing physician. I am still a practicing physician. I have taken the Hippocratic oath, and my primary responsibility is the well-being of my patients. When I was in practice, I was not going to be influenced by marketing hype. I would choose the best treatment available for my patients based on my own information and my review of the science. I trust that my endocrine colleagues have been doing the same thing.

Furthermore, as you've heard from the Canadian Diabetes Association, they have an expert committee, a scientific section, that guides the recommendations of the Canadian Diabetes Association. It's not influenced by any industry. We have no say whatsoever, and they have recommended for many years that human biosynthetic insulin is the insulin of choice.

À (1020)

The Chair: I totally agree with what you said about doctors trying to pick the best treatment, but it's also true that doctors, if they think there's not much difference between two products, will pick the one that their patients can afford. We heard at an earlier meeting that the original price for the synthetic insulin was about $5 for an average dose, whereas for the other it was more like $25, or $20, which means it's $20 versus $5.

So we all assumed at that time, I think, that--

Dr. Loren Grossman: No, that's not correct. I can tell you the average price of the vials now, and in fact the animal insulin obviously costs more now than the human biosynthetic insulin because of simple economics: it's made in much smaller quantities, and there's less of a demand.

I'd have to go back and check, but my recollection, given the usual situation in the marketplace, is that when a new product that is an advancement over previous products is introduced, it goes at a higher price.

The Chair: I wonder if you could check that and send us a list of the studies, who did them, where they were done, and who paid for them.

Perhaps you could also send us a list of the price of an average dose of the synthetic human insulin from inception to today. We understood that the animal insulin was about $20, and when the synthetic insulin was introduced it was about $5, and it has continually gone up. It was supposed to be a big advance; being made in a lab, it was supposed to end up being cheaper. Now, though, apparently the price of an average dose approaches what the animal insulin used to sell for.

Dr. Loren Grossman: I can tell you that the number you've quoted for animal insulin per dose is not correct. I know it's not, because the cost of a vial, which is 1,000 units, is about $15. The average dose per day may be 40 or 50 units, so it's impossible that it could ever have been $20 a dose.

The Chair: I'm just giving you what we were told by somebody.

Mr. McCool, do you wish to comment? Do you remember what the price was?

Mr. Terry McCool: Is it because I have grey hair that I may remember?

Voices: Oh, oh!

The Chair: Somebody has to have the corporate memory. Nobody here could remember what the deal was between the Government of Canada and Connaught Labs, so I'm hoping--

Mr. Terry McCool: I probably remember some of that, too, but it's probably not appropriate for me to comment on that.

The prices were relatively similar. When you say that human insulin is much cheaper to make, that's probably not true. It's a very complex operation to make. Partly because insulin demand is increasing around the world we're continually being stretched to build new facilities just to supply insulin. So it is very complex and very expensive.

In Canada, as most of you may be aware, the prices of insulins have been frozen on most formularies in Canada since 1993. In effect, the price of insulin in Canada is very low relative to prices around the world. As I think Dr. Grossman said, animal insulin is priced a little higher right now than human insulin.

The Chair: I just have one more question for Dr. Sharma.

Dr. Sharma, you keep quoting these adverse drug reactions and the data, and we've also had allusions to post-marketing surveillance. It's my understanding, with adult diabetics who have a job they have to get themselves to every day, who have a mortgage, and who have the usual responsibilities of adults in our society, that they are less inclined to report all these adverse reactions, because one of the first things their family physician will do is lift their driver's licence, which will mean they can't get to work.

So how can we trust the adverse drug reactions data on this particular disease and these particular symptoms when people, I understand, are not reporting? They're very loath to until they have such a severe situation that they're actually scared they might die.

To my understanding, there are people who are having seizures in the night that scare their family members to death and who are still not reporting for fear of losing their ability to drive themselves to work and to keep the family income coming in to pay that mortgage. So it may be true that doctors are reporting the adverse drug reactions they know about, but if diabetics are not reporting them, the doctors don't know about them anyway.

À (1025)

Dr. Supriya Sharma: The adverse event information we get can come from any source. It doesn't necessarily have to come through the health care practitioner. For instance, if a patient who experiences an adverse event believes it may be associated with a product they're taking, they can actually report that directly. So if the consumer--

The Chair: But how many of them do that? I mean, that is a dream world you're talking about.

Dr. Supriya Sharma: We do have spontaneous reporting in Canada, so we do depend on people making that connection and reporting. Through expanding the post-market surveillance program in Health Canada, we're trying to encourage that. When you look at other programs in the world that have mandated reporting, the quality of the reports and the amount of information they're able to get out of it really isn't significantly increased from spontaneous reports. Our challenge is to then use the system we have to expand that. We're increasing our regional centres' budgets, for instance. Those are actually in the different provinces. So you have people who are actually going out and doing information exchanges, trying to increase people's information.

The way to increase reporting is to allow people to say, “If I report this, it's going to make a significant difference, make the difference between one person knowing that one adverse reaction has happened versus a number of people across Canada.”

A 1-800 number has been introduced, so there's a toll-free reporting system. There's an e-mail address people can report to. We've increased the communications we're putting out. There are increased numbers of advisories. There's an electronic list to which people can subscribe to actually get advisories. So a number of efforts are being made to try to move that along.

The other thing is that in terms of the reports that are actually sent in, there's no requirement for people to actually give their personal information, their names or any other information. There's an anonymity to reporting those events. If people are concerned that it will then come back to haunt them, for whatever different reasons, we can assure them that won't necessarily happen, and that information will be put into context with everything else.

The Chair: Dr. Sharma, could you do some kind of summary of the adverse drug reactions that have been reported on these different kinds of insulin and get it to us?

Dr. Supriya Sharma: What sort of details would you be interested in?

The Chair: The year and the number of adverse reactions. And hopefully it will tell us if they're on the animal insulin or the synthetic insulin.

Dr. Supriya Sharma: Yes, absolutely.

The Chair: Just do it in a little chart for us.

Dr. Supriya Sharma: Sure. Actually, that information is available to anyone, whether it's a health care practitioner or a consumer, through the program. At any point in time, through the program, they can make that request and actually get line listings of any product and the adverse events that have been reported in Canada as well. So that information is readily available.

The Chair: Yes. If you could do it for us in a chart form, in a summary form, we'd appreciate it.

Dr. Supriya Sharma: Sure.

The Chair: Thank you.

Mr. Merrifield.

Mr. Rob Merrifield: I have just one quick question for Mr. McCool, going back to the same line of questioning that Ms. Brown started with.

I have a business background as well. I could care less about the retail price of either the synthetic or the animal; I'm interested in the actual cost of production. Can you tell me the cost of production of the human insulin compared with the beef insulin, or the pork insulin?

Mr. Terry McCool: I can't tell you the cost of production. That's information we don't share for competitive reasons. I can tell you that the manufacturing--

Mr. Rob Merrifield: Can you give me a comparison between the two?

Mr. Terry McCool: No, I can't, because I don't have it.

Mr. Rob Merrifield: You don't have the comparison between the two?

Mr. Terry McCool: In terms of cost of manufacturing, I personally don't have that information.

Mr. Rob Merrifield: So you can't tell me that one is cheaper to produce than the other?

Mr. Terry McCool: I can't.

À (1030)

Mr. Rob Merrifield: Okay. Can you find that out and give us that information?

Mr. Terry McCool: What I'm saying is, I cannot share that manufacturing information for competitive reasons.

Mr. Rob Merrifield: Okay. So it's not that you can't, it's that you won't.

Mr. Terry McCool: Right.

Mr. Rob Merrifield: And it's not that you don't know, it's that you won't reveal it.

Mr. Terry McCool: It's both. I personally don't know, and if I did know, I couldn't share it.

Mr. Rob Merrifield: Okay.

The Chair: Mr. Lunney.

Mr. James Lunney: To Dr. Grossman, with regard to the chair's remark, I don't think anyone is attacking your personal integrity as a clinician regarding the Hippocratic oath and so on. However, the effect of advertising is certainly well known. The CPS has probably the slickest advertising in the universe and the smallest-print product monographs and so on.

In a recent survey, physicians were asked who they rely on for information in their choice of drug product--the salesman at the door with his plate of sandwiches every day in his office; the ads in the CPS; or the ads in the referee journals, among other things. It was quite interesting that physicians by and large overwhelmingly related to the ads in the referee journals.

I believe the reason for this is that referee journals of course are peer-reviewed, and therefore they tend to rely on the data as being more reliable. But the ads, of course, are not peer-reviewed. In fact, investigators looking at the ads found there were a lot of errors. This is not really the subject of discussion today, but we are not unaware on this committee of advertising's effect in the drug world on both physicians' prescribing habits and on consumers' demand for product. That's certainly a big concern for us on this committee, the direct-to-consumer advertising .

That's just for the record.

Dr. Loren Grossman: I haven't seen that particular survey, so I can't comment. I'm not surprised. That may be true. What I was referring to specifically in the previous comments was for those people who are at the point in their diabetes management where they are switched to insulin from previous therapy, or people with type I diabetes who are newly diagnosed and have to start insulin, most of them--not all, but a good majority--are managed by tertiary care specialists or secondary care specialists.

Having spoken to my colleagues who are also diabetes specialists in Canada, I would suggest that perhaps that phenomenon might be less likely with tertiary care specialists than with the general practitioning community in Canada.

That's what I meant.

Mr. James Lunney: Touché.

The Chair: Thank you.

Mr. Robinson.

Mr. Svend Robinson: Thanks very much.

I'd like to just follow up on a couple of issues with the representative from Eli Lilly. This is on the question that has been raised around hypoglycemia unawareness and studies that have been done on that.

As I understand it, during a 1988 meeting of the International Diabetes Federation in Sydney, Australia, representatives of your company reported on an analysis, a study that had been done, with respect to the issue of hypoglycemia unawareness. I'd like to ask you whether you're aware of those studies and whether you know if Eli Lilly informed Health Canada officials of this analysis.

Dr. Loren Grossman: I'm really not aware of what you're referring to. Was that 1988?

Mr. Svend Robinson: Yes, 1988.

Dr. Loren Grossman: I was certainly not part of the company at that point. I'm really not sure--

Mr. Svend Robinson: Okay, fair enough. If you could look into that for me, and if there is an analysis that's available, perhaps you could share that with the committee.

Dr. Loren Grossman: Again, what specifically are you referring to?

Mr. Svend Robinson: It was a 1988 meeting of the International Diabetes Federation in Sydney, Australia, at which the study was apparently presented.

Dr. Loren Grossman: I can tell you, just based on the date, that when I referred earlier to the whole story regarding hypoglycemia unawareness, the first cases that started to be reported in the literature, particularly coming out of England, suggesting that human insulin was responsible for this, were occurring in the late eighties, 1988-89, and even into 1990. It was only after that... The stack I'm referring to that's on my desk, and that I'll provide you a list of, from the early 1990s, 1991 to 1993, refuted that.

So I can look into it, but that's clearly old information. It's not relevant to today.

Mr. Svend Robinson: Well, it was a study that your representatives apparently shared at that meeting, so if you could look into it and share that with the committee, I'd be most grateful.

Dr. Loren Grossman: I'll try to find that for you.

Mr. Svend Robinson: To Health Canada, I guess for many of us the key issue here is with respect to the ongoing availability of animal-sourced insulin. I have a copy of the letter that was sent out, a very sort of cold, clinical, market-based letter, on April 25 from Eli Lilly saying they were cutting one form of animal insulin, so tough luck; you have until the end of the year and that's it.

Dr. Loren Grossman: I don't believe it says that.

Mr. Svend Robinson: It doesn't say that, but that's the effect of it.

What is to stop Eli Lilly from, on May 25 or June 25, sending out another letter, a cold, clinical letter saying, basically, we've made a marketing decision, and we'll give you until the end of the year, when we're not going to provide this any more.

Again, I guess this comes back to the issue of leadership. Health Canada acknowledged at the last hearing of this committee that some diabetics need animal-sourced insulin to maintain life. I think those were the words you used, “to maintain life”. Well, this is a company whose concern isn't maintaining life. It's a company whose concern is maximizing return on investment. That shouldn't be Health Canada's mandate.

So what are you in a position to do if Eli Lilly sends out another letter saying they're cutting off the supply of animal insulin, period?

À (1035)

Ms. Julia Hill: We did discuss at the last meeting what some of the strategies might be. None of them are perfect solutions. We have done some research to see who else is producing animal insulins around the world, who else might be willing to seek marketing authorization in Canada. I referred to our discussion with CP Pharmaceuticals around beef insulin precisely because nobody's marketing in Canada right now. We are trying to entice them to put in a proposal to Health Canada for marketing authorization. That will be their business decision, whether they want to market in Canada or not.

We have also had informal discussions, or certainly I have over the last six weeks, with our colleagues in Australia as well as in the U.S. and in England to see what their strategies may be and what the nature of the problem might be in their jurisdictions.

I guess the bottom line is that we encourage and support the notion of informed choice. That's why we've had meetings with Eli Lilly. That's why we've brought the stakeholders, the consumers, together with Eli Lilly and ourselves to see what we can come up with in strategies and reassurances.

Mr. Svend Robinson: But if I may, this is literally a life-and-death choice for some people.

Ms. Julia Hill: Absolutely. I agree.

Mr. Svend Robinson: And you understand that, I know that. But we're in a situation in which basically those whose life depends on this supply of animal insulin--and I read the transcript from the last meeting--are being told that they depend basically on the willingness of a company like Eli Lilly to keep providing it.

Is there no way, for example, Health Canada is in a position to do research and possibly come up with a source of animal insulin themselves, either pork insulin or beef insulin? Is it beyond the capability of Health Canada to do that?

With anthrax, for example, when there was a threatening situation, it was, my God, we'd better make Cipro available to save lives. And here we're talking about saving other lives, by Health Canada's own admission, and yet all I hear you saying is, geez, we're trying to figure out ways of making sure that companies continue to make this available.

Is it beyond the capability of Health Canada to ensure that if another letter goes out like this, Health Canada's in a position to say, okay, this company may have shut down the supply because they're not making enough money on it or whatever, but we will make sure it's available to those whose lives depend on it?

Ms. Julia Hill: If I can come back to your example of anthrax, part of the answer there depended upon there being a company willing to produce a product that could deal with anthrax. We've had similar situations with health crises related to meningococcal issues in B.C. and Manitoba and Quebec, where there was no vaccine for a particular strain that was of concern. We were able to identify a company that was willing to produce the vaccine.

That's exactly--

Mr. Svend Robinson: I appreciate, or I hope, that you're looking for a company aggressively now.

Ms. Julia Hill: Absolutely.

Mr. Svend Robinson: If there's no company available whose corporate decision is to produce this, what do we do? Do we just say to these people, tough luck; your lives may be on the line, but we don't have a corporation that's prepared to produce this?

Ms. Julia Hill: There really isn't a perfect answer. Health Canada does not make insulin or any other drug product. In the Canadian context, it's not seen as acceptable for government to become manufacturers. So that clearly is not something that we can provide.

Do we have--

Mr. Svend Robinson: Hold on now. Just on that, if the choice is between corporations not making this available and people losing their lives as a result--and I'm not sure where this consensus came from that the government shouldn't be involved in producing this if lives depend on it--is that really what you're saying, that in fact we're not even going to examine the possibility of the public making this available if no corporation will do so? Is that what you're saying?

Ms. Julia Hill: We will examine any possibility, but the first step is to assess what is already out there.

Step one, then, is the existing manufacturer who chose to stay on the market when all the others withdrew animal insulins. What is the likelihood at this stage of them withdrawing? We, too, are sceptics about the world in general--I'm not referring to industry--so we don't take anything as being 100% certainty. However, we have a certain level of comfort at the moment that Eli Lilly does indeed intend to continue producing this product. So that's one step.

Step two, who else is out there in the big wide world who produces animal insulins? Who might be interested in marketing in Canada? Who might be the backup plan should the Eli Lilly production come to an end?

Step three would be, at an extreme, what else is out there? We can do some real out-of-the-box thinking; that's certainly within our ability. It's just a question of when do we get pushed to that point?

At the moment we are comfortable that for now Eli Lilly will remain on the market. We believe there is a public pressure as well as a government pressure, and indeed a moral imperative, for any company to provide due notice if they are going to be withdrawing something as important as animal insulin from the marketplace. We do believe that is the case right now. We will continue monitoring and discussing with Eli Lilly--and not just depending on Eli Lilly. We have had discussions and will continue with the patients--

À (1040)

Mr. Svend Robinson: Is there any requirements that they do that?

Ms. Julia Hill: We do not have a regulatory authority that can either force us to make them maintain things on the market--

Mr. Svend Robinson: For a reasonable period of time.

Ms. Julia Hill: We do have moral suasion, however.

Mr. Svend Robinson: I'm not talking about moral suasion. Why don't you have the authority to say, look, you can't just cut off in a month a supply of this drug, you have to give a reasonable notice? Why don't you have that authority?

Ms. Julia Hill: The laws of the land at the moment, which are passed by Parliament, include the Food and Drugs Act, and that is what we respect. Within the Food and Drugs Act we do not have that authority. That is not to say that it could not be built in at some later date, if that were to be the wish of Parliament.

Mr. Svend Robinson: That could be one of our recommendations.

Ms. Julia Hill: That is certainly something we would look at and respect, but we must adhere to the laws of the land that govern us at the moment.

Mr. Svend Robinson: Thank you.

The Chair: Any further questions?

Seeing none, I'd like to thank the representatives from Health Canada, the Canadian Diabetes Association, and most especially Eli Lilly--they were hard to get here, but we finally did get a date--for coming and sharing their information with us. I would remind them that there are certain undertakings that various witnesses have agreed to provide to us as we continue our study of this topic.

As chair, I continue to get letters from individual Canadians telling me what in my view amount to horror stories about their experiences with this human insulin. I don't know whether some of them aren't reporting to their doctors, whether the doctors aren't reporting the adverse drug reactions, but certainly the impression we have from earlier witnesses and from the mail I'm receiving is that there is a problem here. And yet I'm not getting that feeling this morning from the witnesses. Obviously we have a puzzle, and we will continue to investigate this puzzle until we have some level of satisfaction.

We're appreciative of the scientific expertise of Dr. Grossman and Dr. Di Fonzo, but I still have questions in my head trying to synthesize the various sets of information we've been given by people of good will--including yourselves--who have come here to share their best knowledge with us.

With that in mind, I would say to the committee members that you'll recall that we have set a second session. I hope it won't be two hours. Seeing as some of our colleagues are at other committee meetings right now, I'm going to suggest that we take about a 15-minute break and reconvene at 11 o'clock to go over the recommendations for the HIV/AIDS study. I hope we can do that in 30 to 40 minutes.

Mr. Svend Robinson: Perhaps I can just ask as well that if there are some questions that arise from this morning's evidence we have an understanding that we can submit those, I guess through the clerk or through the chair, to the representatives of either Eli Lilly or Health Canada for follow-up.

The Chair: Yes, that's the usual modus operandi here.

We may come back to you with more specific questions as our discussions continue, if that's agreeable.

Thank you very much. This portion of today's meeting is adjourned.

[Editor's Note: Proceedings continue in camera]

[Editor's Note: Public proceedings resume]

Á (1115)

The Chair: Mr. Merrifield.

Á (1120)

Mr. Rob Merrifield: I fail to understand why the last dialogue could not be recorded as part of the meeting, but if it can't, I'll continue.

My motion is actually a very simple one. My motion would be for the standing committee to call the health minister and her department to this committee to be able to give us the updated information with regard to SARS and to be able to answer questions of the committee on the way in which she has handled this entire situation over the last month, or a little more than a month. I think it's our duty as members of this committee to be able to have her come and explain how she's handled it and why things have happened the way they have, and to give us the latest update as to what's going on.

I think one of the problems we had last night, although we had an emergency debate on it--and if it was valuable enough to have an emergency debate in the House of Commons, surely it's important enough for this committee to call her here to answer questions--was that we did not have an opportunity to ask the questions to the minister. We had an opportunity to give our dialogue to the debate and our concerns to the debate. We had five minutes, through the grace of the House, to be able to have a couple of quick questions to the minister, but that was very much insignificant in the sense of what we could do here.

We should be calling her at the earliest convenience. And “at the earliest convenience” is not a vague term; it means as soon as possible, hopefully tomorrow or later today.

The Chair: Thank you.

Mr. Robinson.

Mr. Svend Robinson: Madam Chair, I also had submitted a letter to the chair requesting urgently a meeting with the Minister of Health and her senior officials on the issue of SARS.

This is the Standing Committee on Health, and one of the most pressing and urgent health issues facing Canadians is SARS. It is literally incredible that it appears that at least some members on the government side, on the Liberal side, are not prepared to allow this committee to hear the minister and to question the minister with respect to the government's response to SARS. This is a fundamental issue of accountability.

We heard from Madam Folco who said, well, the minister spoke last night in the House, in the emergency debate, and she went through line by line what the government has done. That misses the point completely. The minister may have spoken last night and given her response to what happened, and there was a grand total of five minutes of questions and comments afterwards, but with all due respect to Ms. Folco, it totally misses the point. The point is, those of us who have questions about the government's response to SARS weren't able to ask those questions during the emergency debate. She may have been able to give her speech, and Ms. Fry may have been able to give her speech, and others could speak, but it's an issue of fundamental accountability. We're here presumably to speak on behalf of the Canadian people, to ask questions on behalf of the Canadian people. There are questions, and not medical questions, about how this government has responded. The buck stops on the desk of the Minister of Health. All we're saying is, let's get the minister before the Standing Committee on Health; it should be accountable for this.

As I say, members of the government can say, no, we're not going to allow this, we're going to vote against hearing from the Minister of Health on SARS. But I can tell you, there will be serious accountability for that decision. If you want to vote against hearing from the Minister of Health on SARS in the health committee, you can stand up and defend that in front of the Canadian people.

The Chair: Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay: First of all, Madam Chair, I must say that I will not be intimidated by this type of threat. My position is that we were informed last night about everything the department has been doing since the beginning. The minister described very well the way in which the situation developed, and I fail to see why we would simply hold meetings for the sake of holding meetings.

Once more information is available, I'm sure the minister will share it with us at that time. So I must tell you that at the moment, I see no point in having the minister appear before the committee in the next two or three days, given that last evening she did a very good job in setting out exactly what was happening with the SARS issue.

[English]

The Chair: Thank you.

Mr. Lunney.

Mr. James Lunney: Thank you, Madam Chair.

Well, to repeat, the SARS event is certainly the most significant health event in recent history in Canada, and indeed probably in the world. International travel being affected as greatly as it has, seeing travellers with masks on, hospital shutdowns, police at the gates of our hospitals--this is probably one of the most significant health events any of us have experienced in our lifetimes.

The Chair: You're very young, Mr. Lunney.

Some hon. members: Oh, oh!

Á (1125)

Mr. James Lunney: I won't comment on that.

With regard to the consequences of this epidemic, if we can call it that, it's a highly contagious disease. The consequences perhaps have been overplayed, certainly with a lot of help from the media, with very drastic consequences for the city of Toronto. Nevertheless, it is a very great concern to Canadians, and we have a responsibility in this committee to ask questions of the minister.

With all due respect to the emergency debate last night, it was Monday night, and a lot of members were still in travel. I was in travel. Many of us who would like to have participated and to have asked the minister questions were not able to do so.

I would like to put it on the record, though, that we did appreciate the briefing just before the break, about two weeks ago, when the minister and officials gave us an up-to-date briefing. It was very helpful for members going out into that break period over Easter. However, I feel that it certainly is time that we had an update from the minister and from health officials as to the consequences, and certainly the very serious consequences, of the World Health Organization travel advisory against people coming to the city of Toronto and to Canada. That has very serious implications for Canada, for our economy, and it needs to be addressed for the record.

The Chair: Madam Folco, then Madam Fry, then Madam Scherrer.

[Translation]

Ms. Raymonde Folco (Laval West, Lib.): Thank you, Madam Chair.

Many things have been said, and I too will repeat myself for the record.

I would like to make several points. First of all, last evening, as a number of people have said, I was at the emergency debate, and I would like to repeat to my colleague opposite that Monday is a working day for members of Parliament. It is a day on which Parliament sits, and yesterday evening there was an emergency debate. It was an emergency, so the debate was called at the last minute, but that does not excuse the fact that some individuals could not be present.

That said, the minister gave a detailed explanation of what the federal government, her department and she herself had done, with the dates, beginning on about March 4, if I remember correctly. In other words, from the very early days of March. She told us about the Canadian government's involvement in the epidemic in Toronto and elsewhere in Canada. She gave us a detailed explanation of what she had done and what she intended to do. That does not mean that she would not have anything to say, but I think that unless there are some new developments, which could happen, but to my knowledge there have been no such developments since yesterday evening, I do not see any merit in asking the minister to appear before us so quickly to repeat what she set out so well yesterday evening.

Second, and others have said this as well, I was not present at the briefing, but it was open not only to members of this committee, but to all parliamentarians. So everyone had access to this information. I think we can request another briefing; that would not be a bad idea.

Third—and this may be the most important point— it is my impression that the members of the committee have forgotten that in this case the prime responsibility lies not with the federal Department of Health, but rather with the various provincial and territorial departments of health. They are on the front lines and they are the ones that have to respond to the crisis initially. Our role is to provide assistance, to provide assistance with consultation, but the provincial health departments have the main responsibility for dealing with this disease. I think this point has been forgotten.

Consequently, if there were any new developments, I would very much like the minister to come and talk to us about them. However, I do not think that there have been any new developments since yesterday evening, when the debate was held.

I will be voting against this motion, Madam Chair.

[English]

The Chair: Thank you.

Ms. Fry.

Ms. Hedy Fry (Vancouver Centre, Lib.): Thank you very much, Madam Chair.

I think Ms. Folco said most of the things I wanted to say, but I will say them again anyway.

I would like to vote against this motion. I think the points Ms. Folco made are very important ones. This is a provincial issue for the Province of Ontario...and one for the Province of British Columbia. Contrary to what everyone is saying, this is not a national emergency. There are no cases in any other provinces other than suspected cases.

However, the federal government is and has been doing exactly what the people who understand the disease are deciding about the game plan, about the strategy for this, and these are the public health officials. They have been in touch with the minister every day, with the department on a daily basis, not only nationally but internationally, and with the Atlanta Centers for Disease Control.

So everyone is on top of what's happening. The federal government is doing what it should do, which is to coordinate, to facilitate, to give support in terms of a lot of personnel, money for masks, etc., and all of the things they were asked to do.

That's neither here nor there. What people are saying is that they want an update. There was one given two weeks ago, which Mr. Lunney referred to. I think it would be very appropriate to have a similar one, to let us know what has been going on, for everyone in that same manner.

Mr. Robinson said that on behalf of the public of Canada, we need to be able to ask the minister questions. There is a time every day, for three-quarters of an hour, and it's called question period. You can ask the minister questions there. I don't see everybody breaking the door down to ask the minister questions during question period. There were about three or four questions and that was it.

Secondly, there was a full debate in the House last night. The House was...well, I know one shouldn't refer to it, but the House was empty. Very few people were there. If they were so all-fired interested to come and listen to the debate, to ask questions, the minister took questions after her speech. They were not there to put on paper what they had to say. They were not there to come and discuss this in an open forum.

So, Madam Chair, I want to vote against this motion, very strongly.

Á (1130)

The Chair: Madam Scherrer hasn't had a turn yet.

[Translation]

Ms. Hélène Scherrer: Thank you, Madam Chair. I will probably be saying much the same thing, but with a slightly different focus this time.

I do think that SARS must not be treated in a cavalier fashion. What is happening at the moment is very important as well, and I was one of the people who asked for a committee meeting with the minister or with the officials as early as a few weeks ago. I did that because I thought we could not disregard what is going on at the moment and that we needed to take a very careful look at the situation.

I also tabled a motion, because I thought it was urgent that the Health Committee look at this matter. As you said, I spoke about it with some people from the department, and the very next morning, after they spoke with Ms. McLellan, she told me that she agreed. She thought that the matter was of interest and she agreed with my position. However, she thought that we should not restrict the presentation to the Health Committee, but that it should be open to everyone, because people from all parties and ridings are being affected by SARS. She said that we should look into the issue, bring together the officials and allow everyone to ask all the questions they might have on the problems that are cropping up.

This briefing was held and very few people turned up. I asked all of the questions I wanted to ask about all of my concerns, and the time was taken to answer all the questions that were asked. I think this type of briefing is probably the best response to the current situation. It goes beyond a meeting around this table, where we are limited in what we can do.

Even today, we see that we had trouble getting quorum. I think the debate should include all the parties and all parliamentarians. To my knowledge, yesterday we got a report on everything that has been done to date. I remain very open to the possibility of requesting another briefing, and I will probably be requesting that if it is necessary or if the situation evolves differently. However, I will ask that the briefing not be limited to members of the Health Committee, but rather that it be open to all members of Parliament from all parties, so that they may ask questions very openly. I hope that as a committee, we will be able to react very quickly, and if next week things take a turn for the worse, or if we really want to ask more questions about what will happen in the days ahead, I hope we will keep a very open attitude.

I fail to see why we would welcome only the minister, to ask her questions about what she did in the past. What I am much more interested in is what is being done to control the disease from week to week or day to day, so that we can answer the questions Canadians are asking. To my knowledge, this should not be restricted to the Health Committee. Rather, we should ensure there is another briefing open to everyone.

That is why I will be voting against this motion to hold a committee meeting. I'm much more in favour of having a briefing session where officials would come and answer questions asked by any member of Parliament.

[English]

The Chair: Mr. Robinson wants to respond.

[Translation]

Ms. Raymonde Folco: I call for the vote, Madam Chair.

[English]

Mr. Svend Robinson: Learn the rules. Please;

[Translation]

“I call for the vote!”

[English]

This is the health committee.

The Chair: Madam Folco, can I just inject one thought here?

We've now spent about half an hour on this. That's not to suggest that this is not important, but the report we're going to work on is a report that affects something like 3,000 deaths every day, HIV/AIDS, and this SARS thing is 21 deaths. Granted, they're Canadian deaths, but I want to make sure we have enough time to deal with the larger report.

Go ahead.

Mr. Svend Robinson: Madam Chair, look, this is the Standing Committee on Health. If the Standing Committee on Health can't agree on inviting the Minister of Health with her officials to come before this committee for the first time since--and I underline that--the outbreak of the SARS epidemic to brief the committee and to give this committee an opportunity to ask her questions, this committee is completely ludicrous. It's a farce if we can't do that. It really is. I say that with a sense of sadness, but also with a sense of anger.

What's the Standing Committee on Health supposed to be about? Madam Folco earlier said, well, you know, the minister spoke last night in the House, in the emergency debate, where she gave her position, and that should be good enough. But as elected representatives, we didn't have an opportunity to ask her questions. There was a total of five minutes of questions and comments, and the only reason that happened is that I asked for it. I got unanimous consent.

That's not accountability. The Canadian people expect that we're going to ask some questions.

Madam Fry is from British Columbia. She will know that 24 leading scientists, including Dr. Brunham from British Columbia, have asked the Minister of Health to fund, on an urgent basis, research for a vaccine. That's important; it's half a million dollars they're asking for. I want a chance to ask the Minister of Health--it's under her bailiwick--in the committee, not just in question period, not at the grace of the government during an emergency debate. I want to have a chance to ask her questions about what's happening around a vaccine. I want to have a chance to ask the Minister of the Health what's happening around public health strategies.

I mean, that's something the health committee should be concerned about. What's happening around public health strategies? What follow-up was there on the reports of the Auditor General from 1999, from 2000, from 2002? I want a chance to ask the minister those questions. I'm not asking for a chance to be able to go and listen to the minister in the House give a speech.

Mr. Castonguay said we don't need threats here and so on. I made the point before, that if members of the Liberal Party are going to vote against, in the Standing Committee on Health, asking the Minister of Health to appear for the first time, each and every one of you--and I mean it, because it's a recorded vote--who votes against this will be able to justify that to your constituents.

Ms. Fry in Vancouver Centre will explain why she said, no, I don't think the health committee should be holding any hearings with the Minister of Health about SARS. Ms. Bennett, Madam Folco, Mr. Castonguay, Madam Sherrer, and Madam Thibeault, if you can justify to your constituents saying, no, we don't think the Standing Committee on Health should hold any hearing with the Minister of Health on SARS, then I'm sorry, what does that say about this committee? Again, I'm a new member of the committee, but what does it say about this committee that this committee can't even hold a hearing with the Minister of Health? What it says is that there is an incredible degree of arrogance on the part of the Liberal members of this committee and of the government, and I sure as hell think...and I hope that members of this committee....

No, that's a fact. What you're saying is that you're not prepared to allow the committee to hear from the minister.

Á (1135)

The Chair: You're impugning motives.

Mr. Svend Robinson: You can call it what you want. I call it arrogance and indifference.

The Chair: Thank you, Mr. Robinson.

Ms. Bennett.

Ms. Carolyn Bennett (St. Paul's, Lib.): I think it's a very sad thing. One of the problems is that SARS is so important, it ought not to have been turned into a finger-pointing political football. It would have been, and I still think it should have been, possible to bring the minister here to have a frank discussion about the future, and about the emerging knowledge we're getting every day on this disease, and how we are disseminating it, and the good news story that it really has been about SARS. But I am so disappointed in the partisan stuff that's been going on...that the risk of turning this into some frigging circus that scares people even more....

I wonder whether we can do this without it becoming a circus. You know, I don't know what I'll do, but the behaviour of the opposition....

When you actually have Rick Anderson quoting Tony Clement commending Minister McLellan in the Sunday Star in the Toronto paper, and you have every single member of a government in this country, which is on the front lines with this disease, commending what's been going on in a collaborative fashion, and politicians, who have nothing to do with this disease, nothing to do with the management of it, are the ones being critical, it's really, really disturbing.

We have scared Canadians so that they can't even go into a frigging Chinese restaurant because they don't know the difference between a community acquired disease and a hospital acquired disease. They think people have been getting into this country with the disease. After the first case, that's not the case. They think that people, because they weren't properly checked out in this country, have been taking the disease to Australia, when indeed they haven't.

I am really fed up with the partisan stuff. I had always thought that parliamentary committees were the place where we could actually be non-partisan, and on this issue I am really concerned.

I would like to say that I do think a televised parliamentary committee session on SARS would be really important if we could actually cut to the chase and talk about how we do this collaboration, about what is the future of a public health infrastructure, about the dollars that are assigned, and about how we can find a consensus that would involve every level of government.

I've never been so disappointed in what I've seen politicians do than in the grandstanding stupidity that has taken place in the last three weeks. It's been a total disservice to Canadians, and I had thought better of people. I've never been a great fan of the Government of Ontario of the time, but when I see them behaving better than federal politicians, it is really disturbing.

I don't know what to do. I may just leave the room, because I don't even want to vote on this. I wish I could vote for this motion. I wish I could insist that it was televised. But I am really disturbed that it will turn into some stupid finger-pointing blame game. I have no confidence that this won't happen at that meeting.

I don't know what I will do, but I may just go to my next meeting. I am fed up with this nonsense.

Á (1140)

The Chair: Last word to the mover, quickly.

Mr. Rob Merrifield: Okay.

Interesting debate; nonetheless, I disagree 100%. We have a minister who ignored the recommendation of the WHO.

Ms. Carolyn Bennett: No.

An hon. member: No, that's untrue.

Mr. Rob Merrifield: Do I have the floor or don't I, Madam Chair?

The Chair: You have the floor, but I would ask you to be more judicious in what you say.

Mr. Rob Merrifield: No, no, those are the facts.

On March 27 the WHO recommended that the screening be appropriately done at the airports of Toronto and Vancouver; actually, “in Canada” is what they said. The recommendation said that there should be appropriate screening, which was not the decision that was made by this minister. The decision by this minister was to use a questionnaire pamphlet. It was a voluntary questionnaire. It was inappropriate at that time, and she needs to answer for that. She needs to learn from that so that when the next one that comes along....

SARS kills only 5% or so of those who contract it, but the next one might be much worse. We can't afford to make that mistake again, to allow that mistake again. We need to have the minister here to be able to answer those questions as to why the decision was made. If we're not prepared to do that, and if this committee is going to hide the minister from that kind of questioning, I think it's doing an injustice, and it is not doing the job it should be doing. If we vote this motion down, then you're just trying to protect the minister. The minister can answer those questions.

If I'm wrong, then let the minister stand here and defend herself. She doesn't need you to do it, she can do it herself. I would suggest that you should allow her that opportunity.

The Chair: I did say last word to the mover, and now I have two more hands.

Do you not think we could vote on this and get it over with?

Ms. Hedy Fry: Madam Chair, I would have wanted us to vote on this, but I think that enough things have been said around this table right now, that are on the table as part of a publicized debate, that they must be corrected.

Last night, Madam Speaker--

Mr. Rob Merrifield: Madam Chair, if I had the last word, then I had the last word.

Ms. Hedy Fry: No, she's discussing whether or not you should have the last word, and we're speaking to that.

The Chair: No, I suggested that after saying this, I saw hands, and I can't stop them.

Madam Fry has the floor, and then Mr. Robinson.

Ms. Hedy Fry: Madam Chair asked a question, and I am responding to that particular question.

There has been a huge amount of disinformation. I think Dr. Bennett said it, that what has happened right now with SARS is that everyone is terrified.

An hon. member: It's your fault.

Ms. Hedy Fry: Anxiety is feeding the fact that you see people walking down the streets in Toronto with masks on, that you see people running onto planes with masks on. None of this is warranted, but this kind of--

An hon. member: It's your fault.

Ms. Hedy Fry: Excuse me, please. Would you allow me to finish speaking without--

An hon. member: I thought she was talking.

Ms. Hedy Fry: Then you'd better listen, because the chair just said Ms. Fry, and that's my name. I haven't changed it recently.

I really think this is ridiculous. There is a childishness going on here that bothers me a great deal, this “you said, I said, no, I did not say”. The point is, the reason that many of us do not wish to see this....

As Dr. Bennett said, I would like to vote for this, but I can't, because exactly what is happening now will continue to happen. It will be a three-ring circus. It will be televised, and the people of Canada will be listening to this. They'll be running out of their homes, trying to find ways to protect themselves from the fact that everything is going to hell in a handbasket.

I think there is a process here right now, and I think it has been suggested that we do the briefings. There have been two briefings. Mr. Lunney said he thought the briefing was a good briefing. So let us have another updated briefing. We've had the chance to debate. If you want to ask questions of the Minister of Health, which are purely political questions that you wish to ask--

An hon. member: [Editor's Note: Inaudible.]

Ms. Hedy Fry: Allow me to finish speaking, please.

If you want to ask health questions, then you shouldn't be asking the Minister of Health, you should be asking the people who know the issues--the experts, the public health experts. The last time I looked, the Minister of Health was a lawyer. So if you're going to ask her questions about the details of the pathophysiology of this disease, about what is going on in research, about what the SARS virus is, which we know is changing....

We've heard, Madam Speaker, misinformation. Mr. Robinson basically said we should put money into vaccines. Well, the CIHR, as many of us have repeated, has already put out.... In fact, they have completely received all their RFPs for vaccine studies. This was done immediately, and this is happening as we speak. We have in Vancouver the genomics...and they have actually found the sequencing. We have the National Microbiology Laboratory in Winnipeg, which was the first out of the gate in coming up with....

I mean, people are already doing this. The money is there. The research is going on. The vaccines are being worked on. All of these things are happening, and Canadians need to know that, not the misinformation that Mr. Robinson gave, or that Mr. Merrifield gave, in talking about a whole lot of things that are completely untrue.

Á (1145)

Mr. Rob Merrifield: Those are the facts.

Ms. Hedy Fry: No, they're not Rob, they're not the facts. They're not. We don't know enough about the disease to make those the facts. If you want the facts, then call the public health people and ask them.

What you really want is to have a big political free-for-all, and I think it's irresponsible, because all you do is scare Canadians. You've scared them enough. Let us ensure that Canadians get the truth. Let us make sure that the people who are on the front lines...and that is one of the reasons why a lot of the politicians in Ontario and everywhere have allowed any information about this disease to be done through the mouths of public health officials. They talk about how they give support, how they put money into health on the economic side, and how they do the things that the officials are asking them to do.

This is a disease, a communicable disease. This is not a plane crash. This is not a flood. We need the need people with expertise, who understand that this is a changing thing and that we're moving quickly on it, to give us the real information so that Canadians can know the facts, and can know what they will do, and can feel that either things are under control from a public health perspective or we don't know what the heck we're doing from a public health perspective.

But this is not a political football. This is where you should bring us together as politicians and talk about what is best for Canadians. This is why most of us cannot vote for this, because this is a joke, this is a game you're playing. I think you shouldn't be playing these games around here. This is too serious an issue to play games with.

The Chair: Mr. Robinson.

I ask you, please cease and desist.

Mr. Svend Robinson: Well, Madam Chair, I've heard a lot of interesting statements in committees, but I want to quote from Hedy Fry: “If you want to ask health questions, then you shouldn't be asking the Minister of Health...[she's] a lawyer.”

That's what Ms. Fry said. What does that say about this committee? The record will show, quote unquote, that--

Á (1150)

Ms. Hedy Fry: You know what I meant.

Mr. Svend Robinson: Hold on; you had your say, and now I have mine.

Ms. Hedy Fry: I repeated later on what I meant.

Mr. Svend Robinson: You said, quote, unquote, “If you want to ask health questions, then you shouldn't be asking the Minister of Health...[she's] a lawyer.” That says it all, doesn't it.

Ms. Fry says that we want to make sure we don't distort the facts. She's absolutely right: This should be based on science. It should be based on an assessment of, (a), how we can prevent future problems, and (b), as part of that examination, what has been the chronology up until now. What were the steps taken? Were there steps that could have been taken that weren't taken? Were there steps that were taken that could have been taken earlier? These are all legitimate questions that we have a right to put to the Minister of Health.

Now, Ms. Fry says we have our facts wrong. I heard Ms. Fry stand up in the House last night and say, and I think she repeated it, that people infected with SARS are in only two provinces, in Ontario and British Columbia. Well, that's flatly wrong.

If you want to talk about getting your facts straight, Health Canada--check the Health Canada figures, and I'd be glad to share them with all members of the committee, including Ms. Fry--has pointed out that this is just completely false. It's smaller numbers, but in a number of provinces, including, by the way, in Quebec--

An hon. member: [Editor's Note: Inaudible.]

Mr. Svend Robinson: You think there are no infected people in Quebec?

Ms. Hedy Fry: Probable, Svend. There are suspected, probable, and active cases. You don't know the difference and you don't want to know the difference. That's troublemaking. It's mischief.

Mr. Svend Robinson: Probable cases.

Ms. Hedy Fry: That's what I said, that there are no cases of SARS. Listen.

This is the kind of nonsense that creates panic. I'm fed up with this, really fed up.

The Chair: Mr. Robinson has the floor. I will ask him to wind up, please.

Mr. Svend Robinson: Those are Health Canada figures in terms of probable cases. There are over 300 probable cases--in fact, 344 probable cases--

An hon. member: Probable means probable; that's what the word means.

Mr. Svend Robinson: Exactly.

An hon. member: It does not mean they have SARS.

Mr. Svend Robinson: Absolutely. Probable--

The Chair: Order, ladies.

Mr. Robinson, I will ask you to sum up very quickly. I would like to go to this vote.

You people have had too much vacation. You've come back ready for bear.

Mr. Svend Robinson: These are all questions that we should be putting to the minister, it seems to me, and I just give that as one illustration of the fact--

The Chair: Please, you'll just start them up again.

Mr. Svend Robinson: --that there are still some serious questions that have to be addressed.

“Probable cases” is the term used by Health Canada. I'm sorry, that's Health Canada's terminology. If you don't like it, tell the minister.

Ms. Carolyn Bennett: [Editor's Note: Inaudible]...the difference before you start talking about where there's SARS.

The Chair: Please, no cross-debate.

Finish up, Mr. Robinson. You're being argumentative instead of just making your point. You've made the same point three times.

Mr. Svend Robinson: Members of the committee have said that people are just trying to score political points. It is not just opposition members of Parliament who have raised serious questions about this issue. I believe yesterday, for example, one of the cabinet colleagues of the Minister of Health raised serious questions. Sheila Copps raised serious questions about the absence of leadership by the Minister of Health on this issue.

So it's not just--

The Chair: Speak to me, Mr. Robinson; don't look over there.

Mr. Svend Robinson: I can look anywhere I want. As long as I speak through the chair, I can look anywhere I want.

The Chair: I know, I know, but it would be better if you spoke to me, because you won't get the same reaction.

Mr. Svend Robinson: So it's not just opposition members who are raising these questions, it's cabinet colleagues of the minister herself who are raising these questions--or last time I looked she was a cabinet colleague.

It seems to me this committee has an opportunity to call the minister, to ask the minister questions about the handling of this crisis, about what we can do in terms of preventing future crises, and about what's happening around the public health strategy that was recommended a long time ago.

So I hope the members of the committee will support the motion, and I would ask for a recorded vote on the motion.

The Chair: We have one more speaker who insists on speaking.

Mr. Lunney.

Mr. James Lunney: Thank you, Madam Chair, for recognizing my right to speak as well, as a member of this committee.

I just want to say, also for the record, that I feel there's been a terrible degree of fear associated with the SARS event, and a lot of media hype that has not been helpful; in fact, it's been quite damaging.

I remember hearing Dr. Turgay, a psychiatrist who had just come out of quarantine himself for two weeks, saying that he is very concerned about the psycho-social implications of this disease. It has nothing to do with the morbidity of the disease itself but the response to the disease.

We are very interested on this committee, and I believe all members of Parliament are, in looking at the research going on. Dr. Fry mentioned the Vancouver initiative in terms of coming up with our response that way, whether it's a vaccine or what's going on in the Winnipeg lab in terms of the identification of the coronavirus, or whatever the pathogen turns out to be.

There are very serious consequences to this disease. They affected our freedom to travel and our freedom even to assemble. The psycho-social implications of this disease are a huge consequence. I think we do need to have a rational analysis and discussion about how we respond to these things, how we did respond, how we should respond, and how we're going to respond in the future. Those discussions by necessity should involve the minister.

As difficult as it is for some of us to worry about how we might do this debate, I think we should, as members of this committee, have a responsible discussion about all of these consequences. I think we can pull ourselves through to do that.

Thank you, Madam Chair.

Á (1155)

The Chair: Are you ready for the question?

Ms. Carolyn Bennett: Almost.

I'd just like to say that I'd like a discussion at some point on the responsibility of the opposition at times like this to actually be speaking from a page that decreases fear and increases the sense of security; on whether there was another way to do this other than partisan politics, using SARS as a case example of what can happen when the disease is in control and the politics are out of control.

Mr. Rob Merrifield: Listen, I have to comment on that.

An hon. member: Oh, come on.

Mr. Rob Merrifield: That's absolutely ridiculous. This disease got out of control, and the WHO gave a travel advisory to Toronto. The reason for that is something we need to examine, why that happened. It was being contained in Toronto. The health workers have done a terrific job, and everyone around this table knows that and applauds that. That's not the issue.

The issue is the lack of leadership by the federal government, and this committee is trying to hide us from being able to bring her here and question why things were done the way they were done. They were not done according to the recommendations of the WHO.

So it is absolutely ridiculous--

Ms. Carolyn Bennett: No, that's not true.

Mr. Rob Merrifield: --just to sit here and say that we are creating a phobia out there. The phobia was created by the lack of leadership by a government over there.

An hon. member: Madam Chair, I ask that you take control of this committee.

Mr. Rob Merrifield: Unless they recognize that, we have a problem.

The Chair: Order!

I am arbitrarily now ending this debate, because it's starting to get silly.

Mr. Svend Robinson: On a point of order, just to be very clear, I am certainly prepared to go to a vote--

The Chair: Thank you.

Mr. Svend Robinson: --but you can't arbitrarily end any debate in this committee, as I'm sure you understand.

The Chair: I know. I understand. I know those are the rules, and that's what I alluded to a few minutes ago.

Mr. Svend Robinson: Okay. Just to be clear.

The Chair: I don't want people coming up with a couple of more sentences, because then it just enrages the other side, and then it's a couple of more sentences, and a couple of more sentences....

Mr. Rob Merrifield: I think we're rather enraged right now.

The Chair: I think we now have had a fulsome debate, if nothing else.

I'll ask the clerk to call the names for the recorded vote.

(Motion negatived [See Minutes of Proceedings]: nays 5; yeas 4)

The Chair: The second motion is Ms. Bennett's, for a 30-day extension for the Hazardous Products Act, which of course is at the....

We've lost quorum. We can't do this now.

An hon. member: That is childish behaviour.

The Chair: Yes, of course; childish.

We've lost quorum, so we cannot do any more of the business of this committee today.

This meeting is adjourned.