ADVERSE EFFECTS OF ‘HUMAN’ INSULIN

[Guest guest]

ADVERSE EFFECTS OF ‘HUMAN’ INSULIN

_http://www.health-science-spirit.com/insulin.html_

(http://www.health-science-spirit.com/insulin.html)

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?