A Little Bit of History
GM Vs animal insulin
Choices – The Evidence
Evidence from people with diabetes
A little bit of history
Action and duration times of animal and GM ‘human’ insulins
Hypoglycaemia and loss of warnings
‘Dead in Bed Syndrome’
The concerns of patients are justified
Availability of animal insulins in the UK
Changing your insulin
What to do if your consultant refuses to change your insulin
Availability of animal insulin if admitted to hospital
Frequently asked questions
Allergic reactions to insulin
A little bit of history
- For nearly 80 years people with diabetes who required insulin treatment used animal insulin, originally beef insulin. In the 1970s highly purified pork insulin became available. All insulin is now highly purified whether beef, pork or GM ‘human’.
- In 1982 genetically modified insulin, so-called ‘human’ insulin, received marketing approval. Approval was given in five months, a remarkably short time when one realises that it was the first genetically produced drug to be licensed and used on people.
- It was claimed that GM ‘human’ insulin was better because it is an exact copy of the insulin molecule produced by the body and therefore it would produce less antibodies. It was also claimed that it would be cheaper, therefore more accessible to people in poor countries and that animal insulin supplies were likely to run out. None of these claims have proved to be the case.
- During the mid-1980s there were widely circulated but untrue rumours that animal insulins were being discontinued. This resulted in the over 80% of people in the UK being transferred from animal to GM ‘human’ insulin but in the majority of cases for no good clinical reasons.
- Within a year or so of the changeover people started reporting loss or reduced warning symptoms of hypoglycaemia, more severe hypos and generally, more problems in controlling their diabetes safely. As time progressed other symptoms were being reported, including extreme tiredness, weight increases, feeling unwell and behavioural changes.
- The majority of people who reported these problems to their doctors were either ignored or not believed and they were even refused their right to change to the beef or pork insulin that had previously suited them. Nearly 3,000 people wrote to the then British Diabetic Association (BDA, now Diabetes UK) but little or no action was taken.
- As a result of pressure from people with diabetes, in the early 1990s the British Diabetic Association (now Diabetes UK) commissioned Dr Natasha Posner to carry out a study of only 384 of the 3,000 letters it had received. However, the study was never published because the BDA claimed that it was ‘too alarmist’.
- In the early 1990s around 700 people attempted to take a class action against the manufacturers of ‘human’ insulin but failed for ‘lack of scientific evidence’. IDDT has since discovered that during this period insulin manufacturer, Novo Nordisk employed a PR company, Key Communications, to "defend the safety profile of human insulin". Key Communications described this as a crisis management programme and it included media training of UK medical spokespeople.
- The adverse effects experienced by some people have not disappeared over the years and more than 25 years after the introduction of ‘human’ insulin, people are still battling for recognition of these problems. It is now evident that some more recently diagnosed people who have never used animal insulin, also suffer the well-recognised adverse reactions to ‘human’ insulin. Once again these have been shown to regress with a change to natural animal insulin.
The evidence from patients and their carers was not, and is not, listened to even though it is clear that for some people a change to animal insulin makes their symptoms disappear.
Most of the medical profession, healthcare professionals, researchers, the insulin manufacturers and, indeed, the UK Department of Health maintain that there is no scientific evidence to demonstrate a difference between animal and GM ‘human’ insulin. It has to be noted that there is equally no scientific evidence to prove that ‘human’ insulin does not cause the adverse effects of which patients complain. No large scale, long-term studies were ever carried out to investigate the adverse effects and an absence of evidence, is not the same as absence of evidence. Indeed, some professionals go even further and declare that GM ‘human’ insulin is better than animal insulin although NO evidence is ever produced to justify this statement. The fact that there is no admittance of the adverse effects is surprising when both insulin manufacturers, Eli Lilly and Novo Nordisk, voluntarily included in Patient Information Leaflets the warning that:
"A change from animal insulins to human insulin may cause a loss of warnings."
The next phase in the development of insulin was the introduction of insulin analogues. The first rapid-acting insulin analogue was introduced in the late 1990s and later long-acting insulin analogues were introduced. Insulin analogues are also synthetic insulins made by genetically modifying, genetically modified ‘human’ insulin.
Some people have adverse reactions to insulin analogues and are better suited to either ‘human’ or animal insulins but the trend now is for everyone to be prescribed insulin analogues despite the fact that they are significantly more expensive and have not been shown to have benefits for the majority of people.