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IDDT Canada

Health Canada issues position statement about the safety of human insulin

Health Canada - The Safety of Human Insulin

Last Updated: 2002-05-09 Important Notices
Human insulins are used worldwide for controlling diabetes. However, recent media reports have claimed that human insulins are not safe. Demands have been made for a public inquiry into how they were approved and for animal insulins to be made more available.

Background
The first human genetically engineered insulin, called a recombinant or DNA-derived insulin, was manufactured by Eli Lilly and approved for sale in Canada in 1983. Another recombinant human insulin, made by Novo Nordisk, was approved in 1993. These human insulins have largely replaced animal insulins because they are more effective and have an excellent drug safety record, both in Canada and in other countries. They have proven so popular that Eli Lilly and Novo Nordisk have stopped selling beef-pork insulin world-wide. Health Canada has no authority to force manufacturers to continue marketing a product.

The Benefits of Human insulins
Prior to human insulins being approved and marketed in Canada, a thorough review of their effectiveness was done. The results of clinical trials, some conducted in Canada, were studied and post-marketing experiences from other countries were examined. The conclusion was that the benefit-risk balance of human insulins was appropriate.

The problem with introducing any foreign matter such as insulin into the body, is that the body recognizes it as foreign and begins manufacturing antibodies to fight it. These antibodies combat the insulin, meaning that more and more insulin must be taken to control the diabetes.

The major advantage of human insulins is that there are fewer anti-insulin antibodies formed than with animal insulins. This means a lower risk of adverse allergic reactions and a lower possibility the patient will need higher and higher doses of insulin.

More than 200,000 diabetics in Canada and millions worldwide use human insulins every day, proof of their effectiveness and safety. However, all insulins can result in hypoglycemia, (too low blood sugar) if the dose taken is more than your body needs at the time. Hypoglycemia can lead to sweating, disturbed behavior and even loss of consciousness or death. Hypoglycemia can happen whether you are using animal or human insulins.

How Health Canada Monitors insulins
Health Canada has monitored the adverse effects that have been reported with human insulins. There does not appear to be any unusual trend with human insulins. The number of adverse incidents is proportionally the same as with animal insulins. Regulators in other international jurisdictions have confirmed similar findings.

The Effects of Switching insulins
The harder it is for you to control your blood sugar, the more likely you are to suffer a variety of reactions, not only to your disease, but also to your insulin. That is why it is so important for you to understand the symptoms and signs of hypoglycemia, which can sometimes be very subtle and hard to recognize, regardless of the type of insulin you use.

Changing from one brand of insulin to another can cause difficulties in controlling your blood sugar level until the correct dose is found. The same is true when switching from animal to human insulins.

Although almost all diabetics use human insulins successfully, there are a few who have more difficulty making the change. It is critical when switching from animal to human insulins, that both you and your doctor take particular care to control your blood sugar.

Insulin Availability
The original human insulins approved for sale in Canada are made by Eli Lilly and Novo Nordisk. Newer versions are also now available. Fast acting insulins are sold by Eli Lilly and Novo Nordisk, and basal or long-acting insulin is sold by Aventis Pharma. These new versions may help provide better control of blood sugar.

· Animal insulins are also still available. Eli Lilly manufactures pork insulin.

· Beef insulin can be imported from a source in the UK via the Special Access Program of Health Canada by calling (613) 941-2114.

The best choice of insulin for you is a decision that should be made after a discussion between you and your doctor.

IDDT comments as follows:
IDDT acknowledges that the vast majority of people with diabetes are able to manage their diabetes satisfactorily using human insulin. Therefore IDDT does not question the safety of human insulin per se. However there is a significant minority of people that have adverse effects when using human insulin are better suited to animal insulin.

IDDT makes the following comments on Health Canada’s statement:

1. Health Canada refer to the major advantages of human insulin. This statement is not supported by scientific evidence. After 20 years in use research shows that there are no clinical advantages for patients from using human insulin as opposed to animal insulin.

2. There are no studies that show that there are advantages for patients from human insulin producing less antibodies than animal insulin. It could equally be argued that the increased numbers of antibodies produced by animal insulins slow down the action of the insulin giving it a smoother and less aggressive action that human insulin so enabling blood glucose levels to be more easily controlled.

3. Health Canada’s statement implies that the only adverse effects to human insulin are hypoglycaemic events. There is a failure to acknowledge the other adverse effects of extreme lethargy, mood changes, confusion and memory loss, weight gain and joint pains.

4. Health Canada’s statement implies that the adverse effects only occur in people that have previously used animal insulin and changed to human insulin. We know that this is not the case because there is evidence of the adverse effects occurring in patients who have never used animal insulin.

5. Health Canada state that regulators in other countries have found that the adverse incidents with human insulin are proportionately the same as with animal insulin, however the FDA statistics in 1995 showed that Humulin [human insulin by Lilly] was the eighth highest of all drugs for reported adverse events. This has never been shown to be the case with either beef or pork insulin.