DISSENTING OPINION

Standing Committee on Health
Report on Animal-Sourced Insulins: Availability for Diabetics

Svend J. Robinson, MP

 The New Democratic Party dissents from this report.  While we support some of the recommendations of this report, we feel that the report does not deal sufficiently with the issue of the safety of biosynthetic insulin.

 My New Democrat colleagues and I acknowledge and value the dedication and hard work of my fellow Committee members in holding hearings with a variety of important witnesses on the subject of animal and biosynthetic insulins.  Like my colleagues, I want to thank all of the witnesses who appeared before us.  Their evidence was of great value for its depth and insight.  Unfortunately, the committee neglected to invite several national and international experts who were recommended by the Society for Diabetic Rights, and who could have contributed critical evidence, which would have addressed concerns with the safety of biosynthetic insulin.

 In its report, the Committee has taken some important steps towards ensuring that Canadians have continued access to animal-sourced insulins; however, it does not go far enough.  The following are the key areas in which we believe that the report must be strengthened: 

1. The report suggests that biosynthetic or recombinant human insulin is a safe alternative to animal-sourced insulins, without acknowledging the very serious health concerns of a significant minority of patients who use these products.  While the report refers to the fact that some people who have been on animal-sourced insulins have been unable to make the transition to biosynthetic insulins, it is silent on the issue of diabetic patients who have similar problems but had never used animal-sourced insulins prior to being placed on biosynthetic insulins.  The government must ensure that Health Canada conducts comprehensive post market surveillance of biosynthetic insulin.  In addition, product monographs should accurately reflect independent scientific evidence.  With regard to the product monographs for Eli Lilly’s biosynthetic human insulin products, there are concerns that the company has neglected to include information that shows there may be a link between arthritis-type symptoms and biosynthetic insulin, even though this link was established in one of their own sponsored studies.  The government must also ensure that Health Canada informs physicians that natural insulin, either beef or pork, is available to patients who present these painful and debilitating symptoms.

2. Furthermore, the government should direct Health Canada to conduct research studies into incidents of hypoglycemia unawareness resulting from biosynthetic insulin.  This condition may be the result of a highly dangerous adverse reaction, but data on its prevalence have not been adequately accumulated or considered.  A recent article published in Diabetes Care reported on the results of a trial (continuous glucose monitoring) which found, unexpectedly, that 62.5% of Type 1 diabetics and 46.6% of Type 2 diabetics are unaware of hypoglycemia when it occurs.  Of these, nearly 74% of hypoglycemic events occur during the night.  It is highly unlikely that the subjects in this study were using pork insulin, and even less likely they were using beef insulin.  A simple follow-up study could determine if there is any difference if patients are placed on Eli Lilly’s NPH pork insulin (which has been shown to be among the least stable of the animal insulins), Semilente pork insulin (available in Europe from Novo Nordisk) or on Ultralente beef insulin (available in England).

3. The government must direct Health Canada to develop, with the guidance of the Committee, an improved system to assist physicians, pharmacists, other health professionals and patients in reporting adverse drug reaction cases related to biosynthetic insulin to the Canadian ADR Monitoring Programme.  Such guidance is required because it appears that those involved in diabetes care are unaware that persistent, inexplicable and severe hypoglycemia is an unacceptable and adverse effect, and very different than the more typical and symptomatic experience with low blood sugar of which most patients who use insulin are familiar.

4. Unfounded assertions were made during the Committee’s hearings that no efforts were being made in other countries to maintain the availability of animal-sourced insulins.  This is fallacious, as there are European nations which have assured the availability of as many as seven different types of pork insulin for diabetic patients.  The government should therefore direct Health Canada to ensure that physicians and patients are aware of the availability of animal-based insulins, both in Canada and internationally, through a concerted campaign to raise awareness.  An “It’s Your Health” bulletin is inadequate.  Furthermore, the government should direct Health Canada not to work only with one pharmaceutical company to ensure that Canadians have on-going access to affordable animal-sourced insulins, both beef and pork, but rather to facilitate access to these products from other producers, either nationally or internationally.

5. The government should amend the Food and Drugs Act so that drugs are approved based on medical need.  The drugs which are approved must represent better value and be shown that they do not compromise safety.  The Act should give Health Canada the necessary authority to require companies to maintain the safest and most effective versions of important pharmaceutical drugs on the market in the event that cheaper or lower-quality substitutes are developed.  The health of Canadians must not be jeopardized by pharmaceutical companies seeking to derive greater profits by substituting inferior products for ones proven safe and effective.  In this regard, the government should adopt higher standards of evidence for approval of new drugs, including a requirement that studies relating to quality of life, mortality, and morbidity be conducted prior to granting approvals.

These are the key areas in which we believe the report should be strengthened.