ADVERSE EFFECTS OF ‘HUMAN’ INSULIN

by Walter Last

This is part of a presentation given by Jenny Hirst, Co-Chair of the UK Insulin Dependent Diabetes Trust in October 1997 at the conference "A Voice for the Guinea Pig?" organised by Consumers for Ethics Research (CERES, P.O.Box 1365, London N16 0BW). It shows the downside of genetically engineered insulin.

MY INVOLVEMENT IN DIABETES is because my daughter, now 27, has had insulin dependent diabetes since she was five years old and had insulin injections for 22 years. People with diabetes do not produce insulin and so it has to be injected and because it is injected in boluses, it has to balance with food and exercise. Sometimes the blood sugar can go too high or too low. It is these low blood sugars, hypoglycaemia or" hypos", that are of constant concern to those living with diabetes, because if the lows remain untreated by an intake of sugary food, then there are physical changes, behavioural changes and eventual seizure or coma. Usually there are warning signs of hypos: pallor, hunger, sweating, trembling. Sometimes these symptoms are reduced or not present at all.

INTRODUCING 'HUMAN' INSULIN

From the discovery of insulin in the 1920s until the early 1980s. natural animal-derived insulins had been used, but in 1982, genetically produced so-called 'human’ insulin became available and by the late 1980s, 84 per cent of the diabetic community (in Britain) had been transferred to ‘human’ insulin and nearly all the newly diagnosed were put straight on it.

However, in 1985/96, patients started to complain of problems, mainly of low blood sugar without the necessary safeguard of warning signs. This meant they could not handle the hypos themselves, required outside assistance from family or friends, or went rapidly into seizure or coma. Additional complaints appeared from family carers -extreme lethargy, behavioural changes (aggression and violence), memory loss, confusion, depression, joint pains, weight increase and changes in the menstrual cycle.

All this happened to my daughter over a period of four of the ten years she was taking so-called ‘human’ insulin. She had tests for all sorts of possible causes, but was told by her doctor there was nothing wrong. By this time, her weight had increased from nine and a half stone (133 lbs/60 kg) to 13 stone (182 lbs/83 kg) in spite of eating very little; she spent all her time, when not at work, asleep and could hardly walk to the nearest bus stop. In sheer desperation she insisted on changing back to animal insulin and within three days showed an unbelievable improvement: her hypo warnings returned, she was no longer confused, the pains disappeared, and over a longer period her memory largely returned, she went back to nine stone and for the first time had regular periods.

One could say this is an isolated adverse reaction. But I was a trustee of the British Diabetic Association, and I knew that between 1986 and 1989 they received up to 3000 letters from people with diabetes or their carers. These were desperate letters, angry letters, but all describing similar problems to those of my daughter after changing to ‘human’ insulin.

But there is more - the changeover took place often without the patient knowing or without discussion, a letter in the post or the pharmacist just gave them different insulin with no warnings. Our doctors assumed that 'human’ insulin would be cheaper and better - assumptions with no evidence except drug company sales patter.

The anger that grew was because, when reporting problems to their consultants, patients were not believed, nor were they believed by the BDA (British Diabetic Association). People were sent to psychiatrists and psychologists, including my daughter and for some life was unbearable. People were told they could not change back to animal insulin.

I resigned from the BDA and a few months later formed the IDDT (Insulin Dependent Diabetes Trust) with Dr Matt Kiln, a GP with diabetes who had experienced very real problems himself.

We gathered information with which to do battle. We gathered information from people with diabetes and we looked at insulin manufacturers, the research and the systems, which are in place for our protection.

TALKING TO THE DRUG COMPANIES

We made contact with patients in Switzerland who already had formed an organisation for the preservation of natural animal insulins. The drug companies and BDA said the problems only existed in the UK and Switzerland, but our investigation showed that in many countries ‘human’ insulin was introduced gradually, unlike the UK and Switzerland where over a relatively short time huge numbers of people were transferred and hence the problems all started to appear at the same time. In the States, for instance, transfer was gradual and is still going on with 300,000 people still using animal insulins, but patients are now starting to complain. In other countries, such as Australia, animal insulins were simply withdrawn, leaving patients with no alternative but to use ‘human’ insulin.

So what did we discover about the insulin manufacturers? We wrote to them but always received the same reply - no scientific evidence of problems and guarantees of animal insulin supplies to the year 2000.

But let's look at the real situation, always bearing in mind that ‘human’ insulin is cheaper and easier to produce than animal but in the UK sells for 50 per cent more than animal. In real terms, the NHS (publicly-funded National Health Service) has been spending £19 million per year more on ‘human’ than if everyone had remained on pork insulin, which was causing no problems.

Basically, the world is supplied with insulin by two major companies, Lilly and Novo Nordisk. In the UK, ‘human’ insulin is supplied by Lilly and Novo, and pork insulin is supplied by one company only - Novo. We are at the whim of commercial decisions, so that insulin producers are able to dictate to consumers and prescribing doctors, which again makes us ask why the doctors have not supported patients on this issue.

But the reality is that the insulin manufacturers...

1. pay for research in diabetes
2. pay salaries of diabetes specialist nurses
3. pay for conferences and all that
4. donate to the British Diabetes Association

We looked at the research and what did we find? In 1980, the first study was published, carried out under Professor Harry Keen with 17 non-diabetic men. By 1982, ‘human’ insulin was licensed and on the market. Remarkably short time considering it was the first genetically produced drug ever to be used on mankind. Was two years really long enough to carry out studies in the whole spectrum of people with diabetes: the young, the old, the pregnant, those with complications? Were these trials carried out and within two years? Nor was there any formal post marketing surveillance.

No large-scale trials have ever been carried out and bearing in mind that there are 350,000 people with diabetes who are insulin dependent in the UK alone, problems are not going to be detected in small studies with 20, 30 or 50 participants. Very few studies of any size have been carried out looking at people in their normal living situation.

We know that there is scientific evidence to show differences between ‘human’ and animal insulins, but this evidence is ignored. There is no evidence to show that" human' insulin has any clinical advantages for patients. We also know that there is very little effective protection for us, the patients or consumers, and that our voices and experiences count for very little. We know that the pharmaceutical industry has power beyond most people's dreams and that the medical profession and researchers are being sucked into this power game. They have lost or are losing control and it is not in the consumers' interests that this should happen.

Vast sums of money are spent on research; only a fraction of which is published and certainly in diabetes, much of it is funded by industry, so we are receiving a biased picture.

I have a daughter, only 27, whose future health and life is no longer in the hands of the medical profession but in the hands of the powerful pharmaceutical industry. Government cannot force them to produce an insulin which they consider to be not commercially viable, but surely the consumers, the medical profession and government could, if they united, insist on obtaining the answer to one very simple question: where is the evidence to show that genetically produced ‘human’ insulin has any benefits for patients to justify the actions that have taken place and the use of ‘human’ insulin as first line treatment?


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The author cannot accept any legal responsibility for any problem arising from experimenting with these methods. For any serious disease,
or if you are unsure about a particular course of action, seek the help of a competent health professional.

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