While the CDA started out helpful, Lilly, Novo, Health Canada and their pals in the US have really done us major damage in Canada. Health Canada shows its ignorance below:


          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)