Because Diabusiness keeps deleting and or renaming the files which show our case, I have copied this Cochrane Abstract here.

They agree with what we've been saying for 15 years!

No relevant differences in efficacy and adverse effects between human and purified animal (mainly porcine) insulin

Date: 2003, 22 Apr

Human insulin has become the insulin of choice for newly diagnosed patients with diabetes mellitus. Insulin companies are eventually not going to maintain different species formulations for a declining proportion of the population with diabetes using animal insulin. Concerns exist about increased hypoglycaemia following transfer to human insulin and availability of animal insulin especially in developing countries. In this systematic review we could not identify substantial differences in the safety and efficacy between insulin species. Many important patient-oriented outcomes like health-related quality of life and effects on diabetic complications as well as mortality were never investigated. Human insulin was introduced into the market without scientific proof of advantage over existing purified animal insulins, especially porcine insulin.

SPOTLIGHT FROM JULY 2002 DIGEST:

Insulin for people with diabetes was only derived from animal sources (pigs or cows) until the 1980s. Biologically synthesised human insulin was then introduced. These human or semi-human products were much more expensive, and heavily marketed.

It was thought that pig (porcine) insulin was more suited for human use than cow (bovine) insulin, with human or synthetic products possibly better. However, the new insulins were introduced before enough trials had been done to assess their effects. There were concerns about possible adverse effects of the new forms of insulin.

A new Cochrane review found 45 trials of insulin from different sources - mostly of human and porcine insulin. The reviewers found no proof of superiority of human over animal insulin, in terms of either diabetes control or adverse effects (including episodes of hypoglycaemia).

The reviewers call for utilisation studies of different insulin types especially in developing countries, so that authorities can be in a better position to negotiate with insulin manufacturers for their communities' needs.

"'Human' insulin versus animal insulin in people with diabetes mellitus"
by Richter B, Neises G

A substantive amendment to this systematic review was last made on 27 May 2002. Cochrane reviews are regularly checked and updated if necessary.

Background: Human insulin was introduced for the routine treatment of diabetes mellitus in the early 1980s without adequate comparison of efficacy to animal insulin preparations. First reports of altered hypoglycaemia awareness after transfer to human insulin made physicians and especially patients uncertain about potential adverse effects of human insulin.

Objectives: To assess the effects of different insulin species by evaluating their efficacy (in particular glycaemic control) and adverse effects profile (mainly hypoglycaemia).

Search strategy: A highly sensitive search for randomised controlled trials combined with key terms for identifying studies on human versus animal insulin was performed using the Cochrane Library (issue 2, 2002), Medline (1966 to May, 2002) and Embase (1974 to February, 2002). We also searched reference lists and databases of ongoing trials. Date of latest search: May 2002.

Selection criteria: We included randomised controlled clinical trials with diabetic patients of all ages that compared human to animal (for the most part purified porcine) insulin. Trial duration had to be at least one month in order to achieve reliable results on the main outcome paramater glycated haemoglobin.

Data collection and analysis: Trial selection as well as evaluation of study quality was performed by two independent reviewers. The quality of reporting of each trial was assessed according to a modification of the quality criteria as specified by Schulz and by Jadad.

Main results: Altogether 2156 participants took part in the 45 randomised controlled studies that were discovered through extensive search efforts. Though many studies were of a randomised, double-blind design, most studies were of poor methodological quality. Purified porcine and semi-synthetic insulin were most often investigated. No significant differences in metabolic control or hypoglycaemic episodes between various insulin species could be elucidated. Insulin dose and insulin antibodies did not show relevant dissimilarities.

Reviewers' conclusions: A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety.

Citation: Richter B, Neises G. 'Human' insulin versus animal insulin in people with diabetes mellitus (Cochrane Review). In: The Cochrane Library, Issue 3 2002. Oxford: Update Software.

This is an abstract of a regularly updated, systematic review prepared and maintained by the Cochrane Collaboration. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).

File Reference: AB003816