Issue 9 / 14 March 2011

A RECENT article in the BMJ focused on how small changes in the molecular structure of insulin to produce “the insulin analogues” bring big profits to insulin manufacturers yet may not improve the metabolic control of diabetes.

Admittedly, the improvements might be marginal by biochemical parameters but there are potential lifestyle advantages that need to be brought into the equation, such as greater flexibility and convenience in administration of insulin and reduced episodes of hypoglycaemia.

Judging the benefits of these changes in insulins is a major debate which cannot be adequately addressed here, but I would like to take the “devil’s advocate” position.

There is clearly a profit motive for the pharmaceutical industry with a need for them to satisfy the pockets of their investors. On the other hand, the cost of a new pharmaceutical product from “go to whoa” is astronomical and they need to be innovative.

Some cynics accuse the industry  of having no interest in the welfare of people with type 1 diabetes, a position I do not hold to.

So the manufacturers are in a truly “catch 22” scenario.

I would like to meet just one diabetologist who can claim that our present management of type 1 diabetes (and indeed type 2 diabetes) is ideal. In type 1 diabetes, there is absolute insulin deficiency and multiple daily injections are needed — a basal dose of long-acting insulin, and an injection of short-acting insulin before each meal.

This regimen attempts to replicate the normal pancreas response of a continuous basal release of insulin with bursts at each meal in response to food. So the research at the level of the insulin manufacturers is to develop insulins that simulate this normal life pattern. The hope is that by doing this, the significant morbidity and mortality from diabetes complications will be lessened.

What is very important is that all new insulin analogues, and indeed any medications for either type 1 or 2 diabetes, must be assessed with well designed randomised clinical trials. Only then will we know whether they do have benefits over and above the currently available products.

But unless governments or individuals chip in “big bucks”, the cost of research is borne by the pharmaceutical companies alone.

This is not meant to be an apologia for industry. It is to point out that we need a balanced view of this situation.

It is a reality associated with the management of a lifelong chronic disorder for which, currently, there is no cure.

Professor Paul Zimmet is the director of international research at the Baker IDI Heart and Diabetes Institute in Melbourne and head of the WHO Collaborating Centre for the Epidemiology of Diabetes Mellitus.

The author has provided consultancy advice to insulin manufacturers sanofi-aventis, Novo Nordisk and Eli Lilly.


Posted 14 March 2011

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