THIS
IS THE RESPONSE (verbatim) FROM OUR MINISTER
OF HEALTH, ALLAN ROCK DATED Nov. 6, 2001
This is in response to your letter
concerning your difficulty in switching from
been/pork insulin to human insulin. The
office of Mr. Bryon Wilfert, M.P., A.M.C.T.
(A). has also been in contact with me
regarding your inquiry. I
regret that I was unable to reply earlier
Since the early 1980s, human
genetically engineered (recombinant or rDNA
derived) insulin has been used successfully
in the treatment of diabetes. These
recombinant insulins have essentially
replaced those of animal origin in the
majority of Canadian diabetics because of
their excellent safety and efficacy profile. These
human insulins represented a significant
breakthrough because they helped address
several problems including: supply
issues,
some safety concerns about animal
sourcing, and the immune responses induced
by the animal insulins which can result in
reduced efficacy for some patients.
Clinical trials, of which some were
conducted in Canada for Novolin-ge, were
performed. I wish to assure you that the human
recombinant insulins were only approved for
sale in Canada after the data were carefully
evaluated by the Canadian regulatory
authorities.
These clinical trials demonstrated
that human recombinant insulin was as safe
and effective as animal-sourced insulin. The
adverse events reported also concur with
animal-derived insulins.
Failure to recognize the symptoms of
hypoglycemia occurs with all types of
insulins, and most studies have not been
able to show a statistical difference in the
recognition of symptoms of hypoglycemia
between animal-sourced and human insulin. The
Product Monograph, which is available to
health care providers and patients, includes
a warning that a few patients have reported
that the early warning symptoms of
hypoglycemia were less pronounced than with
animal-sourced insulin.
It is recognized that there is an
adjustment period for some people who have
used animal insulin for a long time;
however, studies show that most people can
successfully change from animal to
rDNA-derived human insulin with carefully
controlled changeover procedures. This
approach is supported by the Canadian
Diabetes Association (CDA) which provides
information on this subject on their web
site at www.Diabetes.ca/about_diabetes/response.html. You
may also be interested in accessing the CDA
statement on the CBC Marketplace program.
The Canadian Adverse Drug Reaction
Monitoring Programme in
Health Canada monitors adverse events of
health products, and takes measures, as
appropriate, to ensure that such products
available to the people of Canada are safe,
effective and of high quality. I
can assure you that no concerning trend or
pattern of reactions with recombinant human
insulins has been identified and the
benefits continue to outweigh the risks.
I should clarify that federal
regulations cannot require a manufacturer to
market a product. However,
Eli Lilly Canada continues to market pork
insulin and has not indicated any intention
to withdraw this product. While
beef insulin is not marketed in Canada, it
can be accessed through the Department's
Special Access Programme (SAP). This
helps ensure a choice for Canadians in their
insulin products.
Physicians wishing to request a
product through the SAP can refer to
Appendix 5, page A7, of the 2001
Compendium of Pharmaceuticals and
Specialties (CPS) or our web site at:
http://www.hc-sc-gc.ca/hpb-dgps/therapeut/htmleng/edrp.html
for a full description of its mandate and
procedures for requesting an emergency drug. They
may also contact a SAP officer by telephone
at (613) 941-2108, or by facsimile at (613)
941-3194.
Once again, thank you for writing,
and best wishes.
Yours very truly,
Allan Rock
c.c.: Mr.
Stockwell Day, M.P.,
The Right Honourable Joe Clark, P.C.,
M.P.
Ms. Alexa McDonough, M.P.
Monsieur Gilles Duceppe
Mr. Bryon Wilfert, M.P., A.M.C.T. (A) |