PARLIAMENT, 2nd SESSION
Committee on Health
February 3, 2003
Committee on Health
February 3, 2003
by Electronic Apparatus]
Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good
afternoon, ladies and gentlemen.
is my pleasure to call to order what is really
the first business meeting of the new year, and
to welcome on your behalf representatives from
the Society for Diabetic Rights, the University
of Ottawa, and the Department of Health.
meeting was called in response to a series of
communications we have received from the Society
for Diabetic Rights, and from individuals across
the country who are concerned about various
things around synthetic versus natural insulin.
We hope you will explain to us not just a series
of symptoms, but rather what you think has gone
wrong with the system for addressing your
particular illness of diabetes.
call upon Colleen Fuller and then Brenda
Colleen Fuller (President, Society for Diabetic
Rights): Thank you.
much time do we have for our presentation?
Chair: Usually the society would have 10
minutes. How you divide that is up to you.
Colleen Fuller: Okay. I will make the
initial presentation, and I'm assuming there
will be questions and answers during the next
little while. Both of us will respond to the
questions. Is this okay?
Chair: That's fine.
would suggest that you don't go on and on about
your association. Some people tend to do that,
indicating how many members they have, and all
that. What we want to know is what you want from
Colleen Fuller: All right.
name is Colleen Fuller, and I am from Vancouver,
B.C. I'm the president of the Society for
Diabetic Rights. I know you are all aware of our
want to thank the committee for taking the time
and allowing us to make this presentation today.
have about 250 to 300 members across the
country, and we have been working on this. We're
not experts. We're all people with diabetes and
families of children with diabetes, and so on.
asking the standing committee to hold full
public hearings on the question of the
experiences Canadians have had with synthetic
insulin. There are some specific questions.
While I know you've all received the
correspondence we sent to you, these are the
specific questions we're hoping the committee
will be able to address, and the kind of
recommendations that it might be able to make to
Health Canada about how to proceed on this.
question is that there is no real understanding
either of what the experiences are, or how many
Canadians are having experiences with synthetic
insulin. There have been a growing number of
adverse drug reactions reported to Health
Canada, especially over the last year or two.
There have been about 630 or 635 adverse drug
have obviously also received reports from across
the country. There is consistency in the types
of reports we are receiving. There is also
consistency between Canada and other
jurisdictions around the world in terms of the
types of problems people are reporting. But in
Canada, we don't really know what the situation
is. We feel there's a weakness in post-market
surveillance of adverse drug reactions in
Canada. I know this is not just a problem with
insulin, but a problem across the board; but
we're addressing just insulin.
estimates of adverse drug reactions related to
this insulin range from roughly 1% to 3%. A lot
of Canadian doctors estimate 1% to 3% of
Canadian diabetics have had adverse drug
experiences with synthetic insulin. In the
United Kingdom, Diabetes UK, which is the
diabetes organization there, estimates that
approximately 20% of diabetics have problems
controlling their diabetes with synthetic
We just received
correspondence between the Swiss government and
the World Health Organization estimating that
approximately 10% of diabetics have problems
with synthetic insulin. The Swiss government has
asked the World Health Organization to address
the question of the availability of pork
insulin, so there are also problems in that
studies in Europe estimate the number of people
having problems controlling their diabetes with
this insulin is as high as 53%. In the United
States, the Food and Drug Administration says
that Humulin insulin, manufactured by Eli Lilly,
is the eighth-most reported drug for adverse
suggests that not enough attention has been paid
to what the problems are and the experiences
Canadians have had. It's a very wide range; from
roughly 3% to 53% is really what the situation
would like the standing committee to take a
closer look at this, if it's appropriate in your
view—and of course it is in our view—to
recommend to Health Canada that they step up
their program of post-market surveillance with
would also like to see the product monographs
better scrutinized. We think there are some
problems with the product monographs. We have
not had access to all the product monographs,
but have obtained some of them through the
freedom of information avenue.
of the issues addressed by a Cochrane review,
which I'm not sure I referred to in the
correspondence with you, was the question of
antibodies. I was interested in their view,
which was that the claims of the manufacturers
regarding antibodies formed in response to
synthetic insulin were based more on the
promotion of the product than sound evidence.
was interested; looking through our material, I
found that in November 1987, when Novo Nordisk
applied for approval of their insulin, the
reviewer of the evidence submitted by Novo
--of the company in the
concern that this approach
making available the
switching from Connaught/Novo
beef/pork insulins to Novolin
human insulins results in a
significant decrease in insulin
antibody levels after the
transfer” could be considered
concerns were also expressed by the people who
were involved in this question way back then.
They were concerned about whether the way the
companies were addressing and giving information
about antibodies was accurate, or whether it was
think there should be some reviews of the
product monographs for that reason, and also for
other related reasons, which I can address
would like to know what steps Health Canada has
taken to increase public awareness and awareness
in the medical community amongst diabetes
educators, and amongst diabetics themselves,
about the option of using pork insulin as a
viable treatment option for those diabetics who
are experiencing adverse reactions to synthetic
insulin. I'm sure I don't need to go into any
detail with the committee about the really high
level of ignorance in Canada about the
availability of pork insulin. This has caused a
lot of harm to people who are not aware of the
fact they would be able to simply switch
insulin, rather than having to endure these
terrible experiences they're having.
also have some concerns about the problems
people have reported accessing insulin through
the special access program. We think it's
something that can be addressed, hopefully in a
real thing we want in Canada right now is a
national strategy to ensure that animal insulin
is going to be available, not only now but also
in the future. We mean beef and pork insulin,
which is a type of insulin that a good number of
people must have. It is not a question of a
market choice. It isn't a question of choosing
between one insulin and another insulin; it's a
question of using an insulin that will support a
good quality of life and that will not threaten
your life, either by undermining your health or
actually putting your life at risk.
thank the committee for enabling us to make this
presentation. I do have a written presentation,
but unfortunately, as we weren't able to submit
it in time to get it translated, I have only
English copies. I'm more than happy to make this
available to the committee members. We're also
available to answer questions.
you very much.
Chair: Thank you, Ms. Fuller.
we can't distribute English-only copies.
However, the clerk will come and get them and
he'll have them translated and then distributed.
Brenda Johnson (Vice-President, Society for
Diabetic Rights): Actually, rather than do a
particular formal presentation, my intention was
just to answer any questions that people might
Chair: That's fine. Thank you.
from the University of Ottawa, Jan Braaten.
Braaten, you have the floor.
Jan T. Braaten (Endocrinologist and Associate
Professor, Department of Medicine, University of
Ottawa): Thank you.
role will be to discuss the different insulins
over time and the new insulin analogues, or
so-called synthetic insulins. I perhaps should
use the word “analogues” here, since beef
insulin and pork insulin are in that group of
insulin analogues. Still, at this time they
would be in the same group as the synthetic
everybody knows, insulin was discovered in 1921
by Banting and Best. Over the next 50 years we
had only animal insulin, used in different
combinations. We had protamine zinc, we had
lente, and we had NPH later on--all long-acting
insulins--but we have to realize that for the
first 50 years we had only animal insulin, and
for the first 30 or 40 years only the
quick-acting insulin. The people who had insulin
during these years are still alive, and many of
them, even after 50-plus years, are still doing
very well. So it's not that the animal insulin
was bad insulin. The problem was that beef
insulin, with three building blocks different
from human insulin, had a tendency to create
more antibodies. It therefore was more
long-acting, but there were some problems from
the creation of antibodies reacting against the
insulin has only one building block that is
different from human insulin, and the action is
almost identical. So switching from pork insulin
to human insulin had small consequences, but
shifting from beef insulin to human insulin had
major consequences for some patients.
can give you a specific example. I had one
patient who was on the beef-pork mixture. In
North America it's mostly beef, because North
America has more cattle than pigs, and in Europe
there are more pigs, so they have more porcine
insulin. But that's beside the point.
this patient--it's not a secret, it's been
published in newspapers--came to hospital and
was treated for ketoacidosis, and given human
insulin. She had two cardiac arrests because of
the rapid drop in glucose, and refused
absolutely to go back to human insulin. She is
the only one I know who is importing beef
insulin from Britain at this time. She is quite
happy using that beef insulin, and it is well
controlled. She has some complications, but that
is beside the point.
1980 we got human insulin. The way it worked was
that the gene for human insulin was discovered.
It was implanted or transferred into bacteria
first and then into yeast, and then the gene was
inside either the bacteria or the yeast--more
simply, it would cultivate this bacteria first,
and then later on go into yeast--and each yeast
could produce human insulin. So now insulin is
produced in huge tanks, like beer yeast, and
they have as much human insulin as they want
from the human gene.
is not what they call synthetic insulin. This is
basically human insulin. It is the same as we
have in our body, exactly the same composition,
with no difference, no antibody formation.
believed this insulin would be the ideal
insulin. Unfortunately, it didn't work out like
that. Some people didn't like the human insulin.
It didn't inject well, and it had some
complications. Some wanted the beef-pork insulin
back again. However, both the Lilly Company
lately, and Novo Nordisk before that,
discontinued animal insulin because of low sales
and the complication of getting all these animal
pancreas, extracting insulin, and so on. It's
much easier to just cultivate insulin in a big
tank, obviously with yeast, and to get insulin
that was the human insulin that took over, and
which had almost the same effect as pork
insulin. But a few people have noticed some
differences between pork and human insulin. Of
the people who were on beef insulin and were
switched to human insulin, many got into
trouble. What happened was that the human
insulin reacted much faster, and there was no
antibody development that could dampen down the
effect. The result was that people who were
previously very well controlled with one insulin
injection a day, using beef-pork, or beef
insulin—mostly because beef composes about 80%
of the North American beef-pork insulin—got
into trouble with irregular glucose control with
low blood sugar. They needed to use two, three,
or maybe four injections a day, and were still
not being able to get the same control of their
diabetes as before.
have seen this repeatedly. I have been here for
so many years now, and have had a number of
patients who have been through all of these
developments. I've followed them consistently
over time. There is no question that a lot
people who were well controlled in the past,
long-term diabetic individuals, got into some
problems with regulation and had to switch to
human insulin because of the rapid action and
is not always appreciated by practitioners or
doctors who see very few patients with diabetes.
You have to see many people with these problems
over many years before you actually really
believe that it happens. I can tell you this is
a real picture, no question about it.
next step that came into the picture, and I
don't know exactly why it happened, was that we
got the insulin analogues. In these synthetic
insulins, they replace one of the building
blocks in the human insulin molecule with
another block, or amino acid. Insulin has 51
amino acids or building blocks. One of these
amino acids is replaced with a different one,
giving a different action. The molecule changes
shape, changes adhesion to the receptors, and
has a small different effect.
first one, unfortunately, created some tumours
in rat livers. So it had to be discontinued. The
two that are now on the market—one from the
Eli Lilly company and one from Novo Nordisk—have
not been shown to be of any danger as far as
tumour development is concerned.
specific thing with these two synthetic
analogues, called Lispro or Humalog, and Aspart
or NovoRapid, is that they have a very short
action. It's actually about five hours, when the
normal or regular insulin is about eight to ten
hours. But this is with the same number of
molecules of insulin. So it means that someone
taking ten units of the rapid insulin, acting in
five hours, compared to someone taking normal
insulin, acting over ten hours, is obviously
getting much more intense action on their
glucose level. This has led to the problem with
the new insulins. People have been getting low
blood sugar, or hypoglycemia, quickly.
problem is not as prominent in early diabetic
cases, let's say in the first 10 years, and
maybe up to 15 years, when you still have some
regulatory mechanism in the body. But in
long-term diabetes of 20, 30, or 40 years'
duration, which I see quite often, these people
have lost the regulatory mechanism to really
fight hypoglycemia. Stress hormones that defend
people against low blood sugar are minimized in
action, and all kinds of normal regulatory
mechanisms have been disrupted by long-term
diabetes. The problem these people have is the
rapid drop in blood glucose. This is not
stressed very much because few doctors have a
chance to see many of these people. People with
long-term diabetes are not that frequent. The
main problem with this new insulin has been the
rapid drop in blood glucose.
is said about this new insulin is it is a
meal-related insulin. Give the insulin before
the meal and it acts for five hours; therefore,
it takes care of the whole meal peak. That is
obviously true, but if you use ordinary, regular
insulin and you give it half an hour before, you
get almost the same effect. So it's not an
absolute requirement that you use this new
insulin as a meal-related insulin. Then, you
also have to use it three to four times a day.
If you do that, you would expect to get perfect
control. You can control the meal-related
hypoglycemia, the elevated glucose level, and
everything should be perfect when it comes to
has been shown that the overall glucose control
with these new insulins has not necessarily been
better than with the old insulins. The
hemoglobin A1C, which represents the
overall control, has not changed. It doesn't
mean it doesn't change in some studies,
depending on how you do the study and what your
objective is, but in the practical setting over
several years they could not say these new
insulins are better than the old insulins,
because the control level was basically the
same. The reason is, when you use this
quick-acting insulin only, you get certain time
intervals where you get a higher glucose level—there
is no insulin available. But when you use the
older insulins, or the “manual” insulin, you
have better continuous coverage of the glucose
it is not as simple as just talking about
meal-related insulin. It is ideal for meals, but
it is a little bit more complicated than that,
because 24-hour control is what we need, and
there are many times when there is a long time
between meals and you need some long-acting
a new insulin analogue, or synthetic insulin, is
coming on the market in Canada. It is used in
the U.S. It is more or less stable for 24 hours
or more. It is seemingly simply totally stable,
something like the protamine zinc insulin in the
past, which was an animal insulin. It's called
“glargine”— that name is probably
difficult to remember—and it again involves
more changes in the human insulin molecule. This
insulin is seemingly pretty good, but we don't
have experience with it, so we cannot say. Then,
there are a number of other experiments going on
now with all kinds of changes in the insulin
molecule, so you're going to get a whole series
of insulins—and I don't think we need them,
but that's a different matter; that's very
diabetes has to be individualized. We have
people who need fewer than 20 units a day—even
half a unit at a time—and other people who
need 60, 70, 100 units a day and are quite
stable. Individual variations between people are
so enormous that we can not make any statement
about any insulin that is absolutely universal.
All have to be treated as individuals and looked
at in terms of how they are built, because
everyone has a different development of
complications, a different reaction to insulin,
a different diurnal rhythm, and they react
differently to all the hormones other than
insulin. There are so many differences that we
can not make an actual statement that, “This
is right and that is wrong.” We have problems
with the old insulins and we have problems with
the new insulins. Unfortunately, it is not that
think I'd better be open for some questions, if
there are any questions.
Chair: Thank you very much.
move now to the Department of Health and hear
from Julia Hill, who perhaps can explain how
Health Canada has been following this story and
reacting to the—I forget whether it was 300 or
600—adverse reports you've received in the
last year about patients who are having adverse
reactions to the synthetic or human insulin.
Julia Hill (Acting Director General, Biologics
and Genetic Therapies Directorate, Health
Products and Food Branch, Department of Health):
I'd be very pleased to address that. I'd
also like to indicate to the committee that we
have been very appreciative of the constructive
approach the society has taken in their
interactions with the department. It's been a
very good experience for us in terms of
sensitization as well.
bottom line—our first statement—is that
there very clearly are Canadians who need
animal-sourced insulins to manage their
diabetes. We have no doubt about that at all.
acknowledge that it's a matter of concern. The
current science knowledge does not really enable
us to understand why the synthetic insulins or
the human insulins do not work as well for some
people as do the animal insulins, but clearly
that is the case, and these are real people
expressing real problems. So we do take that
the human and the animal insulins meet the
safety requirements. When both types underwent
evaluation, they met the safety needs. And
clearly there are a huge number of Canadians who
use the synthetic or human insulin very safely,
but we do have a concern for those who need the
animal-sourced. The available data that we have
for adverse drug reactions are actually
comparable for both types. Remembering that
there is a much higher number of people taking
the human insulin, there is a much higher number
of adverse drug reactions. But when we do a
comparison, there is nothing to indicate to us
that there are greater problems with one than
bottom line is that diabetes is a very serious,
life-threatening condition. This again
underlines that each patient needs the choice of
the product that responds to their individual
understand the concern of the Society for
Diabetic Rights about access to animal-sourced
insulin. Clearly there were business decisions
taken by companies, in the mid- to late
nineties, that withdrew from the market beef
insulin as well as beef-pork insulin. That was
not a Health Canada withdrawal of a licence;
that was a business decision of the company. We
are left with one licensed company, Eli Lilly,
which does still provide pork insulin in Canada.
The ideal situation would be not to have a
monopoly. The ideal situation would be to have
another company that made that product
available; that would be much more reassuring
leads to questions with respect to the role of
Health Canada. The law of the land is that
government cannot oblige the private sector to
market a product; that is the context within
which we are working. It applies to
pharmaceuticals. Health Canada is responsible
for ensuring that products that are marketed
meet safety standards.
those two comments are not very reassuring to
people who need animal-sourced insulin. So
recognizing that we can't force a company to
market, and we can't impede a company that
wishes to cease producing something, what can we
do? Well, we have been working on that. We're
getting part way, but certainly this discussion
will be very helpful, and ideas from other parts
of the community are very welcome. We don't see
an easy fix to this. We have done a couple of
things. We need to do more. We have issued a
first “It's Your Health”, which addressed
some of the initial concerns that were expressed
to us about the safety of the human insulin. We
are working on a new edition, because we need to
provide more information about animal insulins
and about the existing availability of animal
insulins. That is something that's in the works
continuing to verify that the existing supplier
of pork insulin intends to continue to supply
that insulin. The latest communication we had
from Eli Lilly was on January 29. It said, “At
this time, Lilly has no plans to discontinue
Iletin II purified pork insulin.” The words
“at this time” do not provide any of us with
as much assurance as we would wish. Again,
strictly speaking there is not much Health
Canada can do to force the company to say any
more than that.
have researched other sources of animal-sourced
insulin. We are aware of one in the U.K., which
was referred to by our learned colleague
earlier, and there is access through the special
access program to that product. We're aware of
another one in France and one in Asia. None of
these companies has sought marketing authority
in Canada. Consequently none of these products
can be or has been assessed by Health Canada. We
need to receive the information from the company
and the request.
access to beef-pork insulin and the beef insulin
is possible through our special access program.
It enables physicians and patients to access
products that are not licensed for marketing in
Canada. It's not an ideal situation, and we
recognize that. There are issues. It's not an
assessed product. We can't really talk about the
safety and efficacy of the products that are
released through the special access program;
again, the company has not asked for...and has
not submitted its information.
process represents an additional step for people
who already have an added level of complexity in
managing their lives. And we are aware of the
cost issues, which we hope will be addressed
through FPT discussions that are ongoing.
given that the companies in question have not
sought approval, the only way we can enable
access for these patients is through our
existing special access program. As recently as
last fall, we had a discussion with the CP
Pharmaceuticals Company in the U.K., which is
the current provider of the majority of the pork
and beef insulin coming into Canada. We talked
to them about requirements for submission. We
talked about ways in which we would facilitate—within
the boundaries, of course, of our regulatory
obligations. But what could we do to encourage
them? They had spoken to us five years ago about
coming forward with a submission. They had not.
What could we do to encourage them to do so?
know through exchanges with Ms. Johnson from the
society that there were also discussions there,
and we have explained how the process works.
Again, we are very willing to facilitate, but to
date there has been no submission coming
we remain very much committed to facilitating
any kind of application, to talking to the
companies, to making ourselves available. We
very much want to work with both the society and
any other parts of the health partnership in
Canada to try to find a solution to this. We
will update the “It's Your Health” and
ensure that there is a broadcast that is quite
wide. We will consult before we issue the final
document to ensure that we can address as much
as possible the concerns of the society and
others, because there are others with whom we
interact on these issues. We remain very open to
have brought with me for your information three
technical experts—I'm not a technical expert—Dr.
Supriya Sharma, who is a physician involved in
the post-market surveillance elements of the
program; Dr. Harold Rode, who is a PhD scientist
with tremendous knowledge of the subject; and
Mr. Ian MacKay, who is the manager of our
special access program. We would welcome
questions and discussion.
Chair: Thank you very much, although I'm not
sure if understanding the science any better is
going to help us, when it sounds to me that it's
more the market and economics.
begin the questioning with Mr. Merrifield.
Rob Merrifield (Yellowhead, Canadian Alliance): I
want to thank you for coming in. It indeed is an
important issue and an important discussion.
had the diabetic association in my office
discussing this issue a couple of times—at
least once them, and others I've talked to on
the phone—and I've had letters written to me.
This issue did concern me over the last year as
I became a little more aware of the plight of
the diabetics who were on the animal insulin and
were fearful of not being able to continue to
have a number of questions. First of all, does
it boil down to just economics by the
pharmaceutical companies, or is there something
else? Is the mark-up more on the human insulin?
Is there more profit in providing that insulin
compared with the animal insulin? Those
questions certainly arise.
I was quite aware of it, I sent a letter to the
minister concerning her awareness. This letter
came in actually last Friday, in response. Maybe
somebody on the panel wrote the letter—I'm not
sure—but she signed it, anyway.
think the issue is whether we have a problem
with awareness on the physicians' side of it.
Are physicians knowledgeable enough, or
prescribing the appropriate insulin, and do they
sense, or do they see the animal insulin as a
sort of generation-old treatment? Is that part
of the dilemma that you're sensing?
don't know who would want to tackle that
question; I'm just trying to get a handle on the
Brenda Johnson: Well, on your first question
about the economics involved, there's no doubt
in our minds that synthetic insulin is
definitely cheaper to produce. Pharmaceutical
companies have always stated that it was a
business decision as their reason for removing
the animal insulins.
also interesting to note that over the last few
years especially, doctors, hospitals, nurses,
practitioners, and pharmacists are not even
aware that pork insulin still exists. As a
matter of fact, it's been a very interesting
process to go through to realize how many people
are not even aware there is an alternative here.
We have been told time and time again that
synthetic insulin is better for you, that
synthetic insulin is cheaper, that you'll never
run out of the supply of it, etc. The
availability of even the pork insulin has been
such a well-guarded secret, it's absolutely
yes, in answer to your question, it's obviously
very business related.
Rob Merrifield: If there was more demand for
it, would that not drive the price down on it?
Brenda Johnson: If you looked at the profits
going up as the availability of various insulins
went down, it was very simple to see what the
end result was. They first took off the most
widely used and popular insulin, being the
beef-pork mix. That was the first to go and that
was when Novo Nordisk took off their animal
insulins in 1995, which left one pharmaceutical
company making animal insulins and providing
them in Canada. So they had the monopoly,
obviously, on that too. As the other insulins
were taken away and these synthetics were
basically given to you, regardless of whether
you wanted them or not, the profits rose--
Colleen Fuller: And the price rose. When
synthetic insulin was introduced in Canada, the
cost of a bottle of insulin averaged, I think,
around $6.50 or $7. I might be off by 25¢ or
50¢ or so, but roughly that's what it was. In
1995, when Novo withdrew all of its animal
insulins, beef-pork insulin cost about $10 or
$11 a bottle. Now insulin costs roughly between
$23 and $30 a bottle. There's not really a cost
difference between animal and synthetic insulin.
Animal insulin costs about $21, $22, $23 a
synthetic insulin was introduced, both companies
argued that they would be able to reduce or
minimize the cost of insulin to diabetics
because it was so much cheaper to produce. On a
per-unit basis, the cost of production went down
quite significantly. Instead, what's happened is
that the cost of insulin has increased
I was diagnosed as a diabetic in 1968, it was
$1.19 a bottle and it stayed at that price for
quite a number of years. Then it started
eventually to go up. So from my perspective, the
cost of synthetic insulin has not had a positive
impact on insulin prices. It has, however, had a
very positive impact on the profit levels of the
Rob Merrifield: The special access program
allows it to come from Europe or Great Britain
to here, I understand. Is that correct, Julia?
Julia Hill: Correct.
Rob Merrifield: Is there a cost to the
product because of that access program?
Brenda Johnson: Oh, yes. Speaking from
experience, I import beef insulin from the U.K.
and my first shipment was $930. That's not
covered by any insurance company and that will
last me, hopefully, if I can stretch it out,
because I've been mixing beef and pork insulin
for that reason, for six months.
Rob Merrifield: Is that the product or is
that the program?
Brenda Johnson: Well, that's the product
plus the shipping, the handling, the import
fees, the customs brokerage fees. I worked it
out on a per-bottle basis and it was exactly
$56.11 per bottle for that drug.
Julia Hill: If I might just add to that,
typically provincial formularies do not cover
products that are acquired through the special
access program. Typically, formularies will
cover only products that have been licensed for
marketing in Canada. There are some exceptions
to that, but this is generally the rule.
Brenda Johnson: I was told that the reason
it was not covered by my private insurance
company was that it did not have a drug
Rob Merrifield: So that may be part of the
problem of the awareness and the whole
marketing, because the provincial formularies
don't carry it. Is that what you're suggesting?
Julia Hill: I was really just responding to
the cost question. But if I might, I can just
add two things to what's been said.
are aware that in regard to many products that
are beef-sourced, companies are thinking very
carefully about whether or not they continue
providing them, because of the concerns about
TSE-BSE. So that may be one factor.
other thing I forgot to mention is with respect
to sensitizing doctors. We will be offering to
work with the Canadian Medical Association on
their guidelines for diabetes so that there is
more discussion about the choice of products
available for patients.
Rob Merrifield: I have one final question.
This new product that we talked about, Mr.
Jan Braaten: That's going to come on the
Rob Merrifield: Yes. Would that solve any of
the problems we're looking at here? Would it act
the same way as the animal insulin? You're
saying it's going to stretch over a 24-hour
period--or do we not know that yet?
Jan Braaten: From the literature and the
information we have from the U.S., it is long
acting and will work something like the old
animal insulin, the beef protamine zinc insulin,
with stability over 24 hours. As to whether that
is the real, practical situation, we don't know
for sure yet.
we really need it, that is another question, but
it may replace the beef insulin, possibly.
Rob Merrifield: How far from the market is
it, and what are the costs?
Jan Braaten: It has been in the U.S. for at
least for a year now, and I have patients going
over the border to pick it up. But that is a
Rob Merrifield: So it's not approved in
Canada. Is that what you're saying?
Jan Braaten: Not yet.
Rob Merrifield: Oh, the patent applications.
Julia Hill: I beg your pardon, but it has
been approved in Canada; that was just
confirmed. They just have not decided to market
Rob Merrifield: Who hasn't decided?
Julia Hill: The company.
Rob Merrifield: Thank you.
Chair: Madame Thibeault.
Yolande Thibeault (Saint-Lambert, Lib.): Thank
you, Madam Chair.
need some clarification. I'm having trouble
understanding the whole process involved in
obtaining this drug abroad. There is the Special
Access Program. Could you please explain to me
how it works, step-by-step? I imagine that the
first step is to see one's doctor, but what
happens after that? Who is eligible for this
program? How does one become eligible for it?
I would like to know whether individuals can
decide to write to a company in England or
France, for example, and ask for a certain
amount of the drug, without going through the
Special Access Program.
Julia Hill: There are two questions here. I
may perhaps refer your question to my colleague,
Mr. MacKay, if I am mistaken.
discussing the matter with the patient, the
doctor decides that this is the drug for this
patient. The doctor then sends us a request and
a form. We look at the request and we reply
within 24 hours. As explained earlier, the
product is not assessed by Health Canada; we do
not have any details about it. However, if we
know that there are particular problems with the
product in question, we discuss them with the
doctor. However, it is up to the doctor and the
patient to make this decision. Even if there is
some risk involved, it is their decision. In
other words, this is a medical practice. At that
point, we confirm that authorization for
shipping the product is granted. The doctor
contacts the company directly, and they work out
the details at that point.
to whether any individual could do this, there
is legislation about importing products for
personal use. So not just anyone can import
products for personal use in whatever way he or
Yolande Thibeault: So people have to go
through the program?
Julia Hill: Yes.
Yolande Thibeault: Thank you, that is all
for the time being.
Chair: Ms. Wasylycia-Leis.
Judy Wasylycia-Leis (Winnipeg North Centre, NDP):
Thank you, Madam Chair.
of all, I wanted to thank Colleen and Brenda for
their persistence over the last year. I think it
was a little more than a year ago that you were
on the Hill with a group of family members,
people who had been directly impacted by the
reactions to synthetic insulin, and you had
family members who had lost loved ones and
family members who had experienced significant
disability as a result of the reactions to
synthetic insulin. That had a tremendous impact
on all of us.
here we are a year later. At that time we asked
questions in the House and the minister then
said the issues around supply were looked after
and the issues around the monograph were looked
after, and in fact the possibilities of adverse
reactions were duly noted, and not to worry.
That is clearly not the case.
wrote, then, to the minister in July, so that's
seven months ago, and you wrote to Chris Turner
six months ago. Have you received any answer to
those questions you posed then? I noticed as of
January 9 you had not received any response so
I'm wondering if you have since then.
know we have officials today accounting for some
of what has happened and clearly there's been
some movement. There is an indication on the
part of the department of their intention to
recognize the problem and to work together with
you, but I don't sense that you have received
answers to your questions and we're here today
to hear the witnesses and make recommendations.
on the three critical issues.... First, in
regard to a reporting system for adverse
reactions, is there one, or is it up to the work
has there been any move on the part of the
department--and I'd like both the society and
the department officials to answer--with respect
to the monograph and the fact that you believe
there's misleading information, and it's based
on the company itself and the information they
generate and the problems that arise? What's
happened with respect to that?
third, with respect to supply, most depressing
or shocking of all today is the thought that
Health Canada, which is the body that is
supposed to redress problems from the
marketplace, is supposed to protect patients in
the face of the vagaries of the marketplace, is
saying, we can't do anything, basically.
just can't accept that, and I can't understand
it, because in fact the duties of the Health
Protection Branch are outlined. The act is clear
in terms of the protection of Canadians.
that logic were to apply generally, where would
it end? Does it mean that for my son, who needs
liquid valproic acid to stop seizures on a daily
basis, I wouldn't have an option, even though it
was a life and death situation, if a company
decided not to produce that? We're dealing with
life and death.
the government has the ability to lever some
power vis-à-vis these companies, who are
reliant upon our health care system, who are
making exorbitant profits, and we can't tell
them to provide product.
want to raise these questions. If the officials
are saying they can't from their point of view,
then we have a political challenge and an issue
to raise with the minister and with the cabinet,
because this is not acceptable.
I've gone on too long, but I hope you can answer
some of those questions.
Colleen Fuller First of all, we did write to
the minister in July, and we raised our concerns
about a number of issues that you've just
raised. We haven't had a response back or an
acknowledgment of our correspondence with her.
August, after the Cochrane review issued its
report, which was a very important review of the
existing evidence, we wrote to Dr. Turner and
asked actually for this bulletin to be withdrawn
based on the contradictory information that was
in the Cochrane review. We haven't had a
response from Dr. Turner.
November I contacted the minister's office and
asked when we might expect a response from the
minister, and I was told that it was a political
issue and it was being discussed--or something;
I can't remember exactly what the young woman
told me. She said, keep insisting on getting a
response and you will get a response. So that's
what we've been doing. We wrote again in
feel that there are some people in Health Canada
who are interested in addressing this in a more
complete way. That's just a feeling we get. We
don't know exactly who they are or anything.
It's just that you get signals from different
people and we think there is some interest in
working on this and addressing some of the
issues we've raised.
believe the adverse drug reaction reporting in
Canada generally is not very good. We know that
the ADRs that are filed with Health Canada
represent anywhere between 1% and 10%. That's
pathetic. That's a problem generally. It's a
problem that is affecting us.
have people contacting us. When people contact
us, we encourage them to contact Health Canada.
I know that's why the reports to Health Canada
have increased, because when we get contacted,
all of the people--not all of them, I shouldn't
say that--but a number of the people who have
reported to Health Canada first contacted us. We
encourage them to report if they believe there
is a link between the problems they're having
and the insulin they're taking. We don't say,
only if you're taking synthetic insulin, or
anything like that. We say, if you are having a
problem and you link it to this, report it.
believe Health Canada should be encouraging
people to report--encouraging them. Otherwise,
how is Health Canada ever going to know what's
going on? That's on the ADR reporting system.
the product monographs, we haven't seen all the
product monographs. This is a problem. I know
that Health Canada is in discussions right now
about developing a way to facilitate public
access to those monographs. I support that. I
think it's important. Right now the product
monographs that are guiding practitioners are in
my view inadequate.
going to give you one quick example. In Alberta,
there's a woman who is a member of our
organization who has had horrible problems. In a
study that I referred to in one of my letters
it's referred to as “arthritis arthralgia
myalgia” syndrome. It was documented by a
fellow by the name of Galloway, who worked for
Eli Lilly; I don't know if he was working for
Eli Lilly when he did the study. They identified
this as a syndrome that specifically was linked
to rDNA and pro-insulin, two types of
biosynthetic insulin. For all of the people who
had this problem, when they stopped using the
insulin the problem disappeared or was
we have a woman in Alberta who's reported this
condition, and actually quite a number of
people. They are being put on different types of
drugs to address this problem they're having
because there is no information about this
syndrome in the product monograph or anywhere
else. She is being told by physicians in Alberta
that there is no immune response to synthetic
insulin. This is just not the case.
instead of doctors or pharmacists being able to
get the information on the monograph, they're
not getting it. Why isn't the information there?
That's why we have questions about the product
monograph. We know that some of the problems are
being reported and we've seen studies outlining
the problem, but the doctors and the pharmacists
don't know anything about it. So somewhere
there's a missing link there.
this supply issue, I don't accept either that
the Department of Health can't do anything. And,
by the way, there is so much wrong information
in here, and I hope that people will refer to
the letter that we wrote to Anne McLellan about
this. We received information from the
International Diabetes Federation that Eli Lilly
has already disclosed internationally that
they're no longer producing pork insulin.
Lilly informs us. They inform our members who
contact them. They inform the doctors who
inquire and they inform the Department of Health
that they have no plans at this time to withdraw
pork insulin from the market. There's something
that is not being told to people in Canada. We
have confirmation from the IDF that this was the
information that was disclosed to them by the
Eli Lilly representative in June 2001. So here
we are, a year and a half later, and they still
have not given us the same information that
they're disclosing to their international...to
whomever they are in the IDF.
is a political problem? Because what do we do?
Laboratories produced animal insulin. It was a
condition of their operation in Canada that they
would do this. Novo provided this insulin
through Connaught to the Canadian market and
they had to meet certain conditions in order to
do that, and so on.
the Department of Health can't compel a company
to produce the insulin and we can't get the
insulin that we need, then our lives are going
to be threatened. A lot of us will die if we
can't get pork insulin.
the Department of Health can't intervene in the
market, they have a responsibility to produce
the insulin themselves. That's my feeling about
Chair: Thank you, Ms. Wasylycia-Leis.
Bennett, you have the floor.
Carolyn Bennett (St. Paul's, Lib.): Thank
guess I'm having trouble in terms of efficacy.
The Cochrane Collaboration study said it did not
detect a significant difference in antibody
formation between the human and porcine insulin.
It said there was no substantial difference in
hypoglycemic events and that market forces had
dictated a change in policy.
I would glean from this that it was cheaper, it
was just as good, so they kept going with it.
guess I need to know in terms of whether it's an
arthralgic condition or one of those kinds of
things that obviously you would like in the
product monograph. At the same time, what was
happening to people's hemoglobin A1C,
what was happening in terms of their
hypoglycemic events, how do we know they may
have to put up with a little joint trouble in
order to get much better control, less
retinopathy, less kidney problem?
if I were making my mind up, I'd rather have
less retinopathy and less kidney problem and put
up with a little joint problem. There's no
question that the joint problem should, if
there's a significant amount, show up in a
product monograph so that people don't think
it's something else.
still wondering, what actually is your solution
if it's a market problem? What's the Canadian
Diabetes Association's view of it? Could they go
into business importing the stuff?
I was on the board of the Royal Lifesaving
Society, there were life jackets we thought were
better, so we started to import them and had a
little revenue stream on the side.
a government, how can we make a company do
something that is not a good business plan?And
if it's so great, why doesn't the Canadian
Diabetes Association do it? What actually is the
solution that you're putting down on the table?
Colleen Fuller First of all, I want to
address some of your comments about the Cochrane
review of the evidence. Almost all of the
studies looked at the experiences that people
had for a period of under six months when they
transferred from animal insulin to synthetic
were no long-term randomized clinical trials
looking at the impact of the insulin on diabetes
complications, so we actually don't know if
there's an improvement in diabetic retinopathy,
kidney failure, cardiovascular problems, and so
on. We simply do not know that. There's not
enough evidence addressing those issues. In
fact, there were no randomized clinical trials
looking at that.
were no randomized clinical trials looking at
the impact of the insulin on quality of life and
there were no randomized clinical trials looking
at mortality rates.
these are areas where we simply don't know
what's going on. What we do know is that for the
first six months of patients transferring from
animal to synthetic insulin the experience with
hypoglycemia was that there were no big
differences between the two insulins. And that
actually corresponds, as well, to a lot of the
reports we have received. Some patients, myself
being one of them, immediately reacted to the
insulin. Within 24 hours I was in a coma, and a
lot of people have experienced that. That was my
experience. Most people began having the
experiences that they reported after, I would
say, between eight and sixteen months. That's
probably a fair indication.
Carolyn Bennett: So the study was just six
months, but your experience is that it's people
on it eight to twelve months?
Colleen Fuller: The average length of time
that a study was conducted on the transfer from
one species of insulin to the human insulin was
5.8 months, according to Cochrane. So there's a
lack of evidence, in my view, that gives us the
kind of information we need. So that's that.
Canadian Diabetes Association believes animal
insulin should be available on the market. In
1995, Novo withdrew all animal insulin from the
market and at that time there were 45,000 people
using animal insulin in Canada. Most of the
people who were involved in this issue at that
time--actually from 1983 on--advised really
strongly against transferring people en masse,
but that is exactly the experience in Canada.
patients, 45,000 at a minimum, were transferred
en masse to animal insulin, which is why you
would see an increase in the number of problems
that were being reported probably after that
the Canadian Diabetes Association was pushed by
its members to address this crisis that was
occurring. There were a number of people
obviously who were having problems and reporting
them to the CDA and there was a movement
actually, located in Alberta, of people who
began really hard campaigning to keep animal
insulin on the market.
CDA's position is that animal insulin must
continue to be available to Canadians. They
recognize that there is a significant minority
of people who continue to have problems with
synthetic insulin, and that it is not only
people who had transferred from animal to
synthetic. We're also talking about children,
pregnant women, and newly diagnosed diabetics,
Jan Braaten: I would just mention that
definitely the transfer from animal insulin to
human insulin created a lot of hypoglycemic
episodes in patients who never had them before,
but this was mainly, in my practice, the
long-term diabetic patient, the one who had
instability from before, and had diabetes for
20, 30, 40 years; they were really in big
trouble. There's no question about it. I don't
have any big statistics, but I've seen enough
patients to know this, and this is also from
other doctors who have been in practice for a
long time and had the same experience. There is
no question that we get more hypoglycemic
episodes because of the reactive action and the
dampening effect of antibodies and the animal
some of the new insulins coming out are solving
some of the problems. We cannot totally dissect
that thought yet, but there is no question that
we have a lot more hypoglycemic episodes with
people who could be more controlled.
Carolyn Bennett: As a clinician, why did you
change people's use to human insulin?
Jan Braaten: Because animal insulin went out
of the market. It wasn't available any more.
Carolyn Bennett: Do you believe most
clinicians in this country began the switchover
because of the availability problem?
Jan Braaten: We simply couldn't get it.
First the Canadian product went out and then
Lilly stopped it because they tore down the
factory. It was an old factory and they couldn't
produce more. That was the argument.
that is not only a personal experience, but it
is mostly in the long-term, difficult, diabetic
situations where they had....
Carolyn Bennett: But were there some
patients who were better on the human insulin
than on the previous animal insulins?
Jan Braaten: I don't necessarily think so.
But of course, some would prefer it in the
specific early phase of diabetes. On the other
hand, they might not have had the chance to see
the difference. And then we have had the
tremendous commercial pressure. This is a
Julia Hill: Dr. Bennett, I wonder if I might
ask Dr. Sharma to say a few words on the
Cochrane report, and from a clinical
Carolyn Bennett: Yes.
Supriya Sharma (Director, Marketed Biologicals
and Biotechnology Products Division, Marketed
Health Products Directorate, Health Products and
Food Branch, Department of Health): First of
all, I just wanted to say thank you to the
Society for Diabetic Rights for reporting the
review to us.
know the correspondence had initially gone to
Dr. Robert Peterson of the Therapeutic Products
Directorate. An e-mail response acknowledging
receipt of it did go out. Another letter also
went out last week under Dr. Chris Turner's
signature. It was faxed, so it should be dated
sometime from mid last week. That letter
detailed the fact that we did take the study
of the things we did is to contract an
independent, non-profit, academic group that
specializes in systematic reviews, and actually
has expertise in the biologics area, to take a
look at the Cochrane review.
to answer the question in terms of outcome
parameters, one of the conclusions of the
Cochrane review, and the review of the review,
was that not only were there not significant
differences in terms of detection of
hypoglycemic adverse events overall, but there
also really wasn't a significant difference in
some of the outcome parameters that Dr. Bennett
referred to, which are the glycated hemoglobin
levels. Some of these secondary outcomes they
looked at were fasting glucose levels and
insulin dose. So if you see an escalation in
dose, it may be an indication that it might not
be functioning in some patients as compared to
overall, in terms of the review, the two groups
are really comparable. Again, this is within the
limits of looking at randomized control trials
and at broad-based studies. But when we bring
these populations together, the two groups are
a result, with this new information, we will be
looking at the insulin. We will be amending “It's
Your Health” to make sure we accurately
reflect what we've seen in that review.
overall, the two groups seem to be comparable in
terms of hypoglycemic events, which seems to be
the one that came up the most, and in terms of
Chair: Thank you, Dr. Bennett.
Greg Thompson (New Brunswick Southwest, PC): Thank
you, Madam Chair.
Chair: We should roll our white stone out on
the road; you're here.
Greg Thompson: Thank you, thank you very
much. Now that I know that you're chair of the
committee, I'll be here on a regular basis.
hon. members: Oh, oh!
Greg Thompson: Madam Chair, I'm sure you're
going to be generous in terms of time.
from our witnesses, Mrs. Johnson or Mrs. Fuller,
I'd just like a quick answer to this one, so I
can get on with the point I'm attempting to
many people in Canada have diabetes? How many
sufferers do we have?
Brenda Johnson: In total, type 1 and type 2?
Greg Thompson: Yes, in total.
Brenda Johnson: There are about 3 million.
Greg Thompson: Okay, about 3 million. So we
have 3 million sufferers, and I'm led to believe
we have more people dying from diabetes, or the
effects of diabetes, than AIDS for example. Is
Brenda Johnson: I have no idea.
Greg Thompson: Actually, this was in the
bulletin that we've all discounted as not being
entirely accurate. But I'm taking this from
Health Canada—if we can believe what Health
Canada puts out. I guess that we can from time
to time, although we take exception to some of
the points they put out today.
the tail end of this particular bulletin, which
I think is dated July 2000, it says, “Diabetes
and its Complications Kill More People Each Year
than AIDS...Get Serious About Diabetes”. This
is a pretty strong message.
guess the point I'm attempting to make is that
in your letter to the Minister of Health—which
I am glad you included in the notes before us
today—and in your letter to the standing
committee, you point out there have been over
550 reports of adverse drug reactions to human
or synthetic insulin. Out of these, at least
eight people have died. Is this correct? Are
these numbers correct?
Brenda Johnson The latest numbers are 633
adverse reactions and nine deaths.
Greg Thompson: Nine deaths; that's a pretty
powerful message, I think.
I guess upsets me in this...and it's so typical
of government. I'm not pointing fingers at
today's government. I think all governments,
regardless of political stripe, could be accused
of this. But I do know that you met with
officials from Health Canada, and one of the
things you wanted was a public inquiry. Is this
as close as you've come to a public inquiry with
Brenda Johnson: Yes, sir.
Greg Thompson: Okay. You're being very
polite in allowing me to continue.
upsets me is that they wrote the minister seven
months ago. It's hard to believe that the
Minister of Health hasn't responded, because
it's a political problem. Every problem is a
political problem in a sense, but that shouldn't
prevent the Minister of Health from addressing a
real concern and a serious concern. To add to
that frustration, it has been pointed out by
Julia Hill from the Department of Health here
today that they look at it as a marketing
our witnesses from the diabetes society say,
reading from their letter dated July 22, 2002,
We have been told
on numerous occasions by Health
Canada officials that the
government has no authority to
manufacturers what products they
told to contact the Competition Bureau, which
would be another department. The Competition
Bureau said they were concerned about this, but
they were told it was a health issue so they
couldn't do anything. So we're back to square
question I have for the representative of the
Department of Health, Julia Hill, is what did
your department do upon learning about this? Did
you sort of gather in a room, talk about it, and
then conclude there was nothing you could do?
Taking notes from your statement--and I think
this is accurate--you recognized the
difficulties; you recognized the marketing
difficulties; you recognized the difficulty of
bringing them to the table and forcing them to
do something, but how did you arrive at that
you meet with your legal department? Do you have
notes of those meetings that you could actually
present to the committee so we could analyze and
scrutinize those discussions internally within
the department to determine how to grapple with
this from a legal point of view?
there been any discussion at those higher-level
meetings within the department--as I think my
friend from the NDP has mentioned--on using some
moral authority, in terms of the responsibility
of drug companies to say, “It is a marketing
problem, but on the other hand, we're producing
a synthetic drug here that is obviously costing
us less money than the animal version, and there
is possibly an obligation on our part to ensure
we do the best as a company to assist those
citizens we've assisted over the years”?
you done that? Have you called some of those
company officials into your department to
discuss that? And when those discussions were
held, were legal representatives from your
department and the Department of Justice there
to hear some of what they had to say?
Julia Hill: This is not the only time we
have been faced with this issue of an inability
to require a company to either market a product
or not withdraw a product. It is a frustration
within the department. We have had legal
consultations many times. We have had many legal
opinions on our authority to oblige a company to
market a product. The response has been quite
consistent that we do not have that authority.
moral suasion, we do have discussions with
companies. We talk to them about how we might
facilitate their application process and what we
can do to make it easier for them. Moral suasion
sometimes works, but when it's balanced against
a company's bottom line, we tend to have less
Greg Thompson: Madam Chair, do I have
another minute or two?
Chair: Yes. I'm just so excited that you're
present. You're going to be spoiled for our
first few meetings, then I'll just crack the
Greg Thompson: Thank you very much.
those meetings take place and those legal
recommendations are rendered, are they recorded
and documented in such a way that they can be
referenced for future discussions? We often hear
around this place that government is more
reluctant to say “yes” than “no”,
because “no” is an easier answer. “Yes”
might require a little more work and a little
more ingenuity, and it's often a tougher
is it possible that you could provide us with
some of the legal analysis and some of those
discussions that took place within the
department? Or are those all covered by the
Julia Hill: I would have to return to the
department to see. Some of these are legal
opinions to the Minister of Health, but I
believe there must be some way in which we can
provide members of the committee with
information that would help. I would certainly
commit to doing that on my return.
Greg Thompson: It would be helpful, Madam
Chair, if that could be provided to us. I think
we'd have a starting point. We want to see the
problem corrected; that's what we're here for
Julia Hill: I might just add, Mr. Thompson,
that it is in fact not easier to say “no”
than “yes”. When we are dealing with real
people who call us up and tell us about the
issues they are dealing with on a daily basis,
or when diabetic members of our own staff may be
dealing with these issues as well, it isn't
easier to say no.
Greg Thompson: Madam Chair, I have just one
do know that in the native community the
diabetes problem is a much bigger problem, and
we do know that the reporting mechanisms
probably aren't as good as they should be. Have
you made any special effort to identify those
problems that have been expressed here today?
You have a stronger--that is the word I'm
using--responsibility for our native people from
a health point of view, and you have a direct
responsibility to them in providing health care.
Would you have a set of statistics that might
not be in line with the general statistics in
greater society, if you will, or that would
reflect this problem in the native community?
Julia Hill: I must apologize, but it had
been our understanding that somebody from the
First Nations and Inuit Health Branch would be
here. They do the direct service delivery.
Chair: Oh, she is here.
ask you to come to the table, please, and
Maureen Thompson (Manager, Diabetes Program,
First Nations and Inuit Health Branch,
Department of Health): Ms. Maureen Thompson
(Manager, Diabetes Program, First Nations and
Inuit Health Branch, Department of
Health)Certainly. I'm Maureen Thompson, and I'm
program manager for the aboriginal diabetes
was sitting in the audience and not at the table
because our program doesn't deal with access to
drugs or adverse drug reporting; our program
deals with prevention and awareness and starting
to build capacity of first nations and Inuit
people to manage their own diabetes programs.
That's what we're doing with the first phase of
the Canadian diabetes strategy. It's now under
terms of adverse drug reporting, I'm not aware
that this is done for first nations
specifically. There's a lot of difficulty
involved in identifying first nations people
separate from the general population, unless
they choose to self-identify.
hope that answers your question.
Chair: Don't you have a non-insured health
benefits program that's part of...? Probably
someone you work with would have been able to
answer this question.
Maureen Thompson: There is a non-insured
health benefits program, and I believe there is
a representative here, Georges Nadon.
Chair: Oh, surprise, surprise.
are so shy, and yet we're so nice.
Georges Nadon (Pharmaceutical Consultant, Non-Isured
Health Benefits Program, Firsts Nations and
Inuit Health Branch, Department of Health): I'm
Georges Nadon, one of the pharmacists with
non-insured health benefits.
pick up on what Maureen was saying, first
nations are served by the same health care
providers--doctors, pharmacists, and so on--as
the general population, so the mechanism they
would use to report any side effects would be
the same as for the overall population.They have
to fill out those forms to be sent to Health
Canada to report on side effects. They access
drugs the same way as any other Canadian,
through pharmacies and doctors' prescriptions.
They are responsible for reporting these side
effects if they are made aware of them.
Greg Thompson: Is there a disproportionate
number of deaths from diabetes in the native
community compared to the greater society? In
other words, can you actually make the link
between the number of deaths that might have
occurred in the native community versus the
general population, based on the use of animal
insulin versus human insulin?
Georges Nadon: I can't make that link.
Chair: Can Dr. Sharma answer that question?
Does Dr. Sharma work with Dr. Turner?
Supriya Sharma: We do work together.
Canadian adverse drug reaction monitoring
program collects data on adverse reactions in
Canada. There is no specific designation for
ethnicity on the form. Should that information
be volunteered as part of the adverse reaction
report, it can be reported and documented.
the number of deaths we suspect may have been
linked to insulin products, none had ethnicity
specified, so we can't tell if those patients
were aboriginal or non-aboriginal.
isn't a specific outreach to that population in
terms of soliciting increased reports. However,
there are regional adverse drug reaction centres,
and the funding to those groups has just been
doubled to try to increase outreach and increase
the receipt of adverse reaction reports. It's
not just a matter of the number of reports, it's
the quality of those reports, the amount of
information, and the ability to follow up on
those reports and glean some sort of useful
information from what has been submitted.
Chair: Thank you, Mr. Thompson.
move to Mrs. Chamberlain, at whose request this
meeting is actually happening. Because of her we
are beginning to get some of these interesting
Chamberlain, the floor is yours.
Brenda Chamberlain (Guelph—Wellington, Lib.): Thank
fairness, I want to give the chairman due
credit. After I talked to Brenda Johnson, I
immediately phoned the chairman and she agreed
to at least bring this forth, to determine
whether the committee would consider it. It's
been a joint effort and I thank you, Madam
Chairman. This is very important.
want to see if I understand this correctly. Eli
Lilly is producing animal insulin. Is that
Brenda Johnson: They produce it in the
States. We import it.
Brenda Chamberlain: So you can get that now.
Brenda Johnson: Yes, as of today.
Brenda Chamberlain: So why did you go
somewhere else? Did you not say you went
Brenda Johnson: Yes, CP Pharmaceuticals; I
import beef insulin from them. After my
horrible, horrific experiences on synthetic
insulin, I switched to pork. By the way,
immediately upon switching to pork I got my
symptoms back, which was the best gift ever, I
can tell you, after suffering seizures,
blackouts, a coma, and so on from the synthetic
I found that the pork was a little too
fast-acting for me. For me, it was a little too
strong, so I made the decision that I owed it to
myself to try the beef, and I'm doing
wonderfully on it.
Brenda Chamberlain: It seems to me that
Health Canada has honestly tried to go and see
what they could do, and I think you really have
a good understanding of this. But if this is in
jeopardy, and people can't get the insulin they
need--which they were able to get at one
point--this just doesn't seem right to me, in
Canada. Does it to you?
Brenda Johnson: It is a tragedy beyond
belief for many reasons. One of the reasons is
just strictly from the standpoint that Canada is
responsible for the discovery of insulin in the
first place, and went on to save millions of
lives around the world. Now we don't even make a
single drop. That is so tragic to me.
fact is, we have to sit here and beg someone,
anyone—whether it's Health Canada, the
politicians, the chair of this committee, or
whoever it is—and say, “We need this drug to
survive; we cannot safely use synthetic insulin.”
And if it is true—and we believe we have the
proof—that Eli Lilly has plans to discontinue
it, and in fact has already ceased production,
the existing supplies in our little group will
only last until 2004, or maybe until early 2005.
This doesn't give us an awful lot of time to do
what we are here today to ask you for help with:
either find another supplier; or subsidize CP
Pharmaceuticals, Novo Nordisk, or some other
manufacturer, to bring their insulins into
Canada. Let's subsidize the licensing fees, or
reduce them. Somebody has to take the bull by
the horns and say, “Look, we have a problem
here. Very soon, by the year 2004 or 2005, these
people aren't going to have a supply, period.”
I was talking about my previous imports from CP
Pharmaceuticals, to pay $930 for a six-month
supply is a horrendous amount of money. It is
very unfair to me or to anybody. We have many
people in our group who are on fixed incomes or
on disability, especially because of the
problems they've had over the years. They have
lost their jobs, their licences, and whatever,
because of the effects of synthetic insulin. How
can these people afford $930 every six months?
It's just impossible. It's a horrible situation.
Brenda Chamberlain: Mrs. Hill, do you agree
that Eli Lilly is going to discontinue this? Do
you know this?
Julia Hill: No, we don't.
I mentioned in my remarks, when we have asked
them, we have received an affirmation from them
that for the time being they are continuing to
produce. Certainly that doesn't give us the
comfort level we would like.
to add to Ms. Johnson's comments, we are aware
in the health field that diabetes is one of the
greatest and growing concerns for Canadian
health. We're talking about a number of people
at the moment, whom we are aware of, who need
animal-source insulin. We have no idea how these
numbers may grow in the future.
is a very important, productive part of our
society. Somehow we need to find a solution.
We're ready to be there, but we don't have a
Brenda Chamberlain: To the chair and the
committee, I think we have to put a motion on
the floor asking Health Canada to come back with
some solutions to this. Because if this
information from Health Canada is true—the
group says it's not—that it's 200,000 people,
that's a lot of people.
Brenda Johnson: They are not all
Colleen Fuller: We're not saying that all of
the information in the safety bulletin is wrong.
We're saying the way it addressed some of the
issues around human insulin is wrong. It is not
helpful in properly informing the medical
community about synthetic and animal insulins.
That's what we're saying.
Brenda Chamberlain: But I think the crux of
it is that Health Canada is not disputing
there's a need for this; we don't know if we
have only one source, and if there is any truth
to this. I don't know if there's an ability to
find out, through the department or whatever, if
this is going to be discontinued. Because if it
were to discontinue, it would be a terrible
Julia Hill: If we knew ahead of time that
they were intending to discontinue, it would put
us in a better position as well with anyone else
who might wish to come in with a submission.
Brenda Chamberlain: Exactly.
Julia Hill: But we have asked those
questions. Eli Lilly is quite...and frankly, we
would have no reason to not take them at face
value, either. They have repeated on every
occasion that it is their intention to ensure
availability of this product to Canadians.
said, I must confess that when we see “at this
time”, and those necessary riders, it gives us
cause for concern as well.
Brenda Johnson Our group received
confirmation from the International Diabetes
Federation. It is a huge organization that
encompasses the American Diabetes Association,
the Canadian and British, and is worldwide. They
had an insulin task force set up many years ago
to address the global withdrawal of animal
insulins. We received confirmation from this
task force, saying that, yes, it is true, Eli
Lilly has discontinued already.
then, you can understand our urgency in this
matter, and why we again put together this trip
back to Ottawa to address the problem. We are
simply running out of time.
Chair: It's somewhat understandable, Mrs.
Chamberlain, that Eli Lilly does not want to say
that they're going to stop supplying, because if
they have tanks and tanks of this or whatever,
or the capability of doing it, they are going to
want to have the monopoly they enjoy until their
supply is gone.
Brenda Chamberlain: Exactly.
Chair: They're not going to announce it to
the world in order to get another competitor in
right away, which we might be able to get if the
competitor abroad knew that Eli Lilly was
stepping back from the market.
Brenda Chamberlain: This is a question,
Madam Chair, for you to give some thought to. Do
we need a small in camera session at some point,
with the committee and perhaps Health Canada, to
come up with some recommendations?
Chair: I think so, but not everyone has had
Brenda Chamberlain: No, I agree.
Chair: Could we go on?
Brenda Chamberlain: Absolutely. It wouldn't
even have to be today if you don't want to. I
think, to me, it would be perhaps a reasonable
next step. Then the minister has to be brought
into the picture.
Chair: Okay, thank you for that.
Carolyn Bennett: Have we invited Eli Lilly
Chair: No. We may want to meet as a group to
discuss what we can do next.
Julia Hill: Madam Chair, sorry, I have one
other comment. It's not in defence of Eli Lilly,
but I would like to point out that they did
remain on the market when others made choices to
withdraw. As a question of fairness, I think
that needs to be noted.
Carol Skelton (Saskatoon—Rosetown—Biggar,
Canadian Alliance): Ms. Johnson, you said
you import your insulin. Do you have to go
through this special access program of Health
Canada? How many hoops do you have to jump
through to get the insulin? Is it a difficult
Brenda Johnson: It took me six weeks to get
my order. Since that time, I have been working
with Ian MacKay. We are trying to come up with
some solutions on how to restructure the actual
instructions for doctors and patients to get
this more quickly. I think we've come up with
some good solutions, but the bottom line is that
the paperwork and the cost are horrendous.
enough, because it is not considered to be a
legal drug in Canada, when the insulin is
delivered it has to go either to your doctor's
office or to your local hospital pharmacy. If it
goes to the doctor's office, nine times out of
ten they're not open over the weekend, and their
hours are erratic. It's not at your convenience
that the insulin comes to you.
very important point about the special access
program is that when you order your beef insulin
from CP Pharmaceuticals, you have to pay cash up
front through MasterCard or whatever. They do
not accept any responsibility for the delivery
of the insulin. Therefore, there are situations
like we saw after 9/11, where we heard, not
necessarily for Canadians, that some of our
American friends had shipments held up.
also compromises the integrity of the insulin
itself if it's left sitting on a hot pier in New
York City. Unfortunately, the person who has
bought the insulin and perhaps spent $930 has no
Carol Skelton: You said it's $930. How much
do you pay Health Canada? Do you have to pay
Health Canada for allowing it in?
Brenda Johnson: Oh, no.
Carol Skelton: I just wondered.
Brenda Johnson The costs involved are the
actual costs of the insulin itself. There is a
shipping charge from CP Pharmaceuticals, which
depending on the exchange rate of the day is in
the neighbourhood of $100. Then you pay customs
and brokerage fees. So the grand total of all of
that is $930. When you break it down by vial it
is $56.11 per bottle.
Carol Skelton: When you're diagnosed as a
diabetic and put on synthetic insulin, do you
know how many reactions there are immediately?
Brenda Johnson: Do you mean insulin shock?
Carol Skelton: Yes. How many reactions are
Brenda Johnson: It varies from person to
person. But there is one thing I want to point
out to the committee. I can remember sitting
back many times thinking, how am I going to
explain to people what the difference is between
a reaction on animal insulin and one on
synthetic insulin? If you've never experienced
it, how can you possibly understand?
hate to keep using myself as an example, because
there are so many thousands of us with the same
problem, but the differences between a reaction
on animal insulin and a reaction on synthetic
insulin are very real and terrifying. That's the
best way I can put it.
insulin has a much quicker, unexpected,
unexplained reaction profile, so it leaves you
incapacitated. I have tried so many times to
explain to people that not only are insulin
reactions on synthetic insulin more profound,
they're more prolonged. They're debilitating.
pork or beef insulin, especially since I
switched back, if I'm having a reaction I get
the usual shakes or tremors or the odd feelings
you get. I can go to my fridge, get some juice
and a cookie, or whatever, and five minutes
later I'm fine. On the synthetic insulin, the
reaction would be drawn out for an hour. I would
lose time. I would lose--
Colleen Fuller: Consciousness.
Brenda Johnson: Yes, consciousness.
could be sitting there talking to you like I am
right now and seem quite fine, and then go into
what I called a brown-out, which is
unconsciousness but your eyes are still open and
you can't communicate. You're convulsing, and so
on. This simply never happens on animal insulin.
resumé is long. I've been a diabetic for 33
years. I've been on every type of insulin and
every gadget and gizmo that comes with it--the
insulin pump, the insulin pen, synthetic
insulin, beef insulin, pork insulin, beef and
pork insulin--and believe me, the differences
Jan Braaten: I've heard this story many
times, and what told you was very well said. It
is exactly what other patients say. On animal
insulin they can feel it coming and control it,
but when they get new insulin, they go into
reaction and can't control it. I've heard it
over and over again.
that was a very nice description of how people
feel. It's genuine. It's real.
Colleen Fuller: Perhaps I can add one thing.
were asking about newly diagnosed patients who
have not been on animal insulin. In our
organization we have people who range in age
from 6 years old to about 73 years old. Of
course, the younger the person is the less
likely they will have been on animal insulin.
experiences that younger people have is a
special area that needs a lot more work and
study. Those of us who are on animal insulin
know what an insulin reaction is supposed to
feel like. We know that insulin is supposed to
stabilize your blood sugar levels, and so forth.
Younger people haven't had the experience that
those of us who are on animal insulin have, and
are unable to make the distinction.
we have heard way too many stories about newly
diagnosed diabetics who, after three or four
months, are losing their ability to tell when
their blood sugars are dropping, and have no
ability to control their blood sugar levels. I
have no idea what the percentage is.
member of our organization represents a family
support group in Ontario, with about 143
families. He estimates that about 20% or 25% of
the children in those families have a typical
profile--that is, they cannot tell when their
blood sugar is low; they experience not the
normal insulin reaction, but severe
hypoglycemia; they experience memory loss; they
have no ability to focus or concentrate; they
have diarrhea and vomiting, and so forth and so
don't know how many people, newly diagnosed
diabetics, have these problems, but I think we
need to find out.
Chair: Thank you, Ms. Skelton.
have a few questions, if the committee can stand
a few more minutes.
Carolyn Bennett: And I have a tiny one.
understanding from my researchers is that this
Cochrane review, in most cases, is considered
the gold standard in analysis of such things as
drug products and reactions.
wondering why Health Canada is doing another
study, Dr. Sharma, when they already have one,
particularly when it didn't seem that you were
aware of the Cochrane review, and the diabetes
association had to supply you with it.
Supriya Sharma: We're actually not doing a
separate study. Basically, what we've
Cochrane review, in terms of methodology, is
thought to be very good in a lot of different
ways in terms of studying overall themes in
numbers of studies. So it gives you a way,
instead of looking at 80 patients here, 800
patients here, and 1,000 patients here, to try
to make generalizations of the data. Undoubtedly
it's one of the ways of systematic analysis.
Cochrane review is a methodology, and you can
apply that review in a lot of different ways. It
is standardized to a certain extent, but there
are, for lack of a better word, “different-quality”
a group that specializes in the epidemiology and
actually doing these studies, so what we've done
is to take a look at it and say, as far as
Cochrane reviews and those analyses go, how does
this stack up? What kind of quality review is
this? There have been other Cochrane reviews
that, when you look at it from an epidemiologic
basis, don't look so great, and some of the
conclusions that have been drawn from them don't
necessarily stand up to rigorous scientific or
is not the case with this Cochrane review. It
seems to be a well-thought-out study. The
assumptions that are made, or the other changes
or analyses that were made in this study, seem
to be valid, and the conclusions they've drawn
seem to be valid, but we wanted to make sure we
had experts in that form of analysis take a look
at it and tell us, yes, it's a good study; yes,
it's well done; yes, the conclusions that
they've drawn are valid.
it's not a separate study; it's a review of the
at the end, if in fact it is concluded that this
is a very good study, one of the conclusions is
that large-scale drug utilization studies should
evaluate the situation of worldwide insulin
species use, focusing on the developing world.
So it seems to me that if we're going to do more
studies, we should follow the suggestions that
follow the conclusions of the Cochrane report.
of their conclusions was that:
was introduced without proof of
being superior to animal
insulin; that studies have not
outcomes like satisfaction,
health-related quality of life
and diabetes-related morbidity.
it did not report on qualitative assessments of
patients' own experiences when using different
for one, found Ms. Johnson's explanation of the
difference in her reaction to animal and human
insulin to be very enlightening. I thought it
was very well described, so the thought you put
into it ahead of time....
mean, I got the message, that one hits you like
a ton of bricks, and you can't take the
ameliorating methods you used to, when you
hurried to the refrigerator to get orange juice.
That's pretty clear. And it doesn't seem that
anybody has really collected those kinds of
descriptions from the people themselves.
However, you've explained about the study.
Hill, you talked about, and I really appreciated
your sensitivity here, the patients who are
experiencing all this. That's wonderful, but
then you talked about this pamphlet, called “It's
Your Health”, which, in the background part,
says these human insulins “are more effective
and have an excellent drug safety record”.
That may be true for the majority of patients,
but you don't say that.
don't mention the fact that some people are
having trouble with them. Then you even give an
ad for Eli Lilly and the other drug company. You
say that the other products are “so popular”,
the drug companies have stopped selling
beef-pork. So you give a reason for the
withdrawal of the other products from the
don't think this has anything to do with being
so popular. I think it has to do with being able
to be produced so cheaply. Then once you
withdraw the beef and pork, you bump up the
price of the one that used to be $7, and which
is now $22. So all of a sudden your profit
I don't see any indication of this. This looks
like an ad to support the status quo that has
evolved over the last few years, instead of a
tough, questioning thing that doctors could get,
and which could maybe really help these people
stir up some trouble—because that's what it
voice: I don't know how much help they need.
Chair: I want to know who wrote this. In a
written reply from you, I want to know who wrote
this and who approved it, because I think it's a
Julia Hill: And it so needs to be rewritten.
Chair: Well, no, it was never true in the
first place. It's an ad.
Julia Hill: If I may, it was written in
response to issues we were dealing with at the
time. There had been a fair amount of
communication suggesting that human insulin
should be completely withdrawn from the market.
There was a concern about the panic this was
creating in certain quarters.
Chair: I see. And when was this written?
Julia Hill: It came out last May.
Greg Thompson: So it was at the same time,
Madam Chair, that we were talking about
genetically altered foods.
Chair: Last May? So it's not that old.
Julia Hill: Well, in terms of our evolution
and our awareness—
Greg Thompson: It says July 2000 on it,
Chair: I want to ask another question. I
liked Mr. Thompson's question about the legal
recourses that governments have. I have two
questions based on this.
understand and I learned a long time ago, to my
dismay, that we can't control drug companies and
what they put on the market. It's very sad. But
the cases I deal with in my constituency office
are often from the only patient in my
constituency, or maybe in the whole greater
Toronto area, who has some really, really weird
disease for which there is a medication
available in Europe, but it's obvious to me that
the company doesn't want to invest in the whole
process of getting its drug approved here, if we
only have 10 known patients in the country. And
I understand that.
there any other situation where people are going
to have to go through your program, Mr. MacKay,
where the potential numbers of patients are as
high as those with diabetes? Or is it more what
I have experienced—very small numbers and rare
Ian MacKay (Unit Head, Special Access Unit,
Clinical Trials and Special Access Programme,
Senior Medical Advisor Bureau, Therapeutic
Products Directorate, Health Products and Food
Branch, Department of Health): The special
access program was originally designed to
address the needs of small numbers of patients,
as you've described. The situation we've seen
with the withdrawal of the animal insulins, and
the need to access the product from the United
Kingdom, has still only involved relatively
small numbers. I think we're dealing with about
21 patients, in addition to those who are
currently on the approved pork insulin.
respect to other products, we have seen a number
of products withdrawn from the market over the
last number of years, in the same way some
insulins have been withdrawn. This has led to a
run on these products, if you will, and
pressures to bring in large quantities of drugs
to address these needs. So while the core work
of the SAP deals with small numbers of patients,
we've been seeing growth in the number of
products withdrawn from the Canadian market for
corporate reasons, and which out of necessity
have had to be made available through the
special access program.
Chair: All right. Thank you.
are any of them producing, or do they have the
potential to produce, the numbers required to
address the problem created by human insulin?
Ian MacKay: Certainly, there are some drugs
in the program now that have been withdrawn from
the Canadian market and that would equal or
exceed the numbers of patients currently
confronted with the insulin problem.
Chair: You were suggesting that there could
be large groups of patients, and drug companies
are withdrawing the most commonly used drug, so
these people may have to come to you for the
special access program. How may would there
be--four, five, six, or more?
Ian MacKay: Unfortunately, there are many
more than that.
Chair: How many are there? Just give me a
Ian MacKay: In the last number of years
we've probably dealt with somewhere in the order
of 30 to 40 products that have been withdrawn
from the market, which have--
Chair: Did that involve a large number of
Ian MacKay: Large numbers, no; would be
about half that. The rest of them would be
smaller numbers. Maybe in the order of about 15
drugs that would represent...that have been
withdrawn where there would be large numbers of
patients--i.e., more than the number of
diabetics we've encountered.
Chair: Maybe you make a chart for us showing
the name of the drug, what it addresses, when it
was withdrawn, and how many people seem to have
been affected by that withdrawal. It doesn't
have to be absolutely precise, like a scientific
chart, just your best guess based upon your
Ian MacKay: We have accurate numbers on
that, not just ballpark figures. So that's
something we can commit to providing.
Julia Hill: Perhaps that could be done with
the researchers of the standing committee. I
would just be concerned about taking too much
time from the actual management of the special
access program for research--
Chair: He said he already has the numbers,
so why would it take any time? Doesn't he just
punch it out of the computer?
Julia Hill: I'm just thinking, Madam Chair,
that in terms of doing charts and determining
exactly what your requirements would be, we
Chair: They would help you, for sure.
Julia Hill: Thank you.
Chair: I have one more question. The time is
really up, and I'm testing the patience of my
trying to think of what power we have, and there
are two ideas here. First, the government helped
to start up Connaught, and I believe there was
an agreement that they would be responsible for
insulin. Connaught was bought by Aventis
Pasteur. When they bought Connaught, did they
get out from under its obligations? What do you
know about that? Is that something the legal
staff, the justice people, could help you with,
Julia Hill: Actually, Ms. Fuller was just
saying that she thinks she knows the answer to
Chair: Ms. Fuller.
Colleen Fuller: You probably remember that
there was a big stink about the sale of
Chair: Yes, but I didn't know why.
Colleen Fuller: I don't know all of the ins
and outs as to how the insulin question was
settled. Connaught was in a partnership with
Novo Nordisk, and by the time it was sold to
Aventis, they were no longer producing their own
insulin. There was a distribution agreement with
Novo Nordisk, and they were distributing Novo
insulins in Canada. However, a lawsuit was
launched by the University of Toronto, which I
think was against Connaught, actually, because
of the violation of the insulin agreement. I
don't know the ins and outs of it. That's as
much as I do know. I don't know how it was
settled. The lawsuit was withdrawn.
Chair: Is there somebody here from Health
Canada who could find out? I'm sure the
Government of Canada was at least observing that
whole lawsuit, seeing that it was our contract
with Connaught in the first place.
Julia Hill: We can certainly ask the
question and see what we're able to provide you
Chair: Thank you very much.
have one other question. In your attempts to get
your oar in the water in order to have some
clout in this area, have you ever launched an
inquiry or a protest or something to the PMPRB,
the Patented Medicine Prices Review Board,
considering the tremendous jump in the price of
human insulin after the withdrawal of animal
Julia Hill: Health Canada has a very narrow,
specific mandate within which we are required to
operate. We assess the safety and efficacy of
products. Under the current system in Canada we
have no connection with the way in which prices
are set. That's to ensure that--
Chair: Does the PMPRB come under Industry
Julia Hill: It's an arm's length--
Chair: But that particular body reports to
the Minister of Health.
Julia Hill: But it's quite separate from the
regulatory arm, and there are walls there
have a short question each from Dr. Bennett and
ahead, Dr. Bennett.
Carolyn Bennett: I don't think anybody would
think that patients, and their clinicians, don't
know best what works and doesn't work for them
in terms of optimal therapeutic choices. In an
optimal health care system, we should be able to
provide that buffet of choices for people to
have what they know they need.
well, I guess I still need to hear from Brenda
and Colleen, who are I think pretty impressive,
on whether they think the actual therapeutic
treatment of diabetics in Canada has been skewed
in a way that may not be the best for kids in
that everybody needs to have the full buffet
tried after diagnosis, and a number of people
are immediately being put on human when maybe
the buffet would have been better for them.
I'm hearing from you is that you think, with
this lack of choice, some people may be
receiving suboptimal treatment. Is that your
what are your suggestions as to who else we
should speak to about this? I don't get why the
generics haven't picked it up. Should we hear
from the generics? Who else would you like us to
hear from in terms of why there's this market
vacuum on something that you and the people you
talk to feel you really need?
Colleen Fuller: There were 45,000 people on
animal insulin in 1995, and that market was very
intentionally destroyed by the two companies
that make it, Novo Nordisk and Eli Lilly. And I
do mean they destroyed the market. It wasn't
that people woke up on Monday and said, “Let's
try human insulin”; it was literally
destroyed. So for another company to come in and
try to recreate the market is a challenge, I
think, and I don't know how companies will deal
my perspective, until animal insulin became very
difficult to obtain, the position of the
Canadian Diabetes Association was that the first
line of treatment should be animal insulin, and
there was no reason to put anybody on human
insulin unless they were having problems with
animal insulin. Roughly 1% of people had
problems with animal insulin at that time.
are the challenges now. More people are starting
to use pork insulin because of the work we've
done to let people know that pork insulin is
available. People are now contacting us, of
course, because they're worried it's going to be
pulled. But it's a huge amount of work to get
the information out there and to look at, and
possibly revise, the treatment guidelines.
I don't know the answer to your question, but
this is what I do know. By the most conservative
estimates, if the amount of people in Canada
having problems is 1%, we're looking at 2,000
people who have a problem. If we go with the
Swiss estimate of roughly 10%, we're looking at
20,000 people. Those numbers would include those
both currently diagnosed and those yet to be
need a strategy to deal with this. That's what I
Chair: Thank you.
quick one from Mrs. Wasylycia-Leis.
Judy Wasylycia-Leis: Madam Chair, thank you.
think if there ever was a reason for proving, or
trying to make the case, that access to health
care shouldn't be market driven, we've heard it
today, and I think that's the issue we need to
grapple with as a committee.
Chair, we've heard that the department has felt
immobilized to act in this regard, and yet we
know of other examples where the government has
acted. Look at the issues around waging war, or
responding to anti-terrorism. The former
Minister of Health was going to actually bypass
patent law in order to make the anthrax vaccine
available. And if Canada, God forbid, joins with
the U.S. in terms of a war on Iraq, and there's
a shortage of anthrax vaccine, we know somebody
will find a way to make it available.
think we need to look at the broad issue of the
role of government and the role of the Health
Protection Branch. And not to dump on the
officials here, we need to get the minister or
the top officials before a committee, to be held
accountable for this. Because this is not just
about moral authority, it's also about legal
authority. We have an act that requires access
to necessary drugs as part of our legal
I think we need to find out how to apply the
existing law and the regulatory framework in
terms of safety and efficacy issues around such
basic things as notice and information that goes
out to patients, and we need to look at how we
can guarantee a supply and take the necessary
don't agree with Carolyn that the onus should be
on any of you, as the diabetes association, to
go and start a business. I think we are talking
about universal health care with an onus on the
government to make sure that the--
Chair: Judy, I don't hear a question, I hear
a really big speech.
Judy Wasylycia-Leis: My question is, since
this is our last chance before we pursue this
issue further, what final recommendations would
you make in terms of our report to Parliament in
terms of an action plan on this issue?
Colleen Fuller: I would like the committee
to recommend to the Department of Health that
they develop a strategy to ensure that Canadian
diabetics who require or who want animal insulin
are able to go to the local pharmacy and get
it--both beef and pork insulin. I think there
does need to be a strategy to reach that
what I would like.
Chair: Perhaps 25 years ago it would have
been an easier job for Health Canada to do, but
I think the establishment of the Patent Act in
1988 and the establishment of the PMPRB put the
walls between Health Canada and the drug
companies. This whole prices review mechanism
was to make sure it was fair to the drug
companies, so it seems to me that Health Canada
and various others were sort of shut out.
the problem with these arm's-length bodies;
they're a good idea at the time, but then they
get in your way later.
think also that we can't expect Ms. Johnson and
Ms. Fuller...because this is a whole power
thing. This is about who has the power to do
whatever they want or not, and we're supposed to
figure that out. So I'm grateful for the work
they've done to keep it alive and to keep it
moving, but my conclusion is that the ball's in
our court. This needs political clout, and the
officials at Health Canada also need our help.
Carolyn Bennett: But a partnership may be
possible between the government and the
voluntary sector when the private sector bows
Chair: I couldn't agree more. I'm not trying
to say it's one way or the other. I'm just
trying to say that how to do it is really ours
Brenda Chamberlain: I don't think we should
broaden this. I think we should try to fix this
problem right here.
Chair: Oh, I agree.
was hoping the answer I was going to get out of
Mr. MacKay was that there was no other drug pull
that affected quite so many people, but I didn't
get that answer, which is why I was going to say
to focus on this one.
you very much, ladies and gentlemen.
may have to cancel Wednesday's meeting. We were
supposed to do Bill C-260, but I'm sure you want
to be in the House when Bill C-13 is there
because they're voting on it. And if they're
voting without us, who knows what they might do
with it. The clerk will keep monitoring it to
see if our bill is in the House.
meeting is adjourned.