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Adverse reactions to 'human' insulin:
A survey carried out by IDDT during 1994/95 involving people with diabetes and their family carers about their experiences with synthetic, so-called 'human' insulin showed the following results:
- 41% - loss of warnings of hypos or 'I seem to function on automatic pilot'.
- 34% - extreme tiredness or lethargy
- 9% - sleeping all the time
- 32% - weight increase of 1.5 stones and above
- 28% - feeling unwell all the time
- 24% - memory loss or confusion
- 9% - blood glucose levels dipping and peaking erratically
- 8% - described by their families as 'not the same person'
- 5% - mood changes, described as difficult to live with
- 7% - pains, especially in the legs and joints
- 4% - irregular or late periods
24% of people who contacted IDDT said that their doctor was unwilling or reluctant to change their insulin to natural animal insulin.
Other common statements were:
- 'I didn't know that there was such a thing as animal insulin.'
- 'I was never told there were alternatives'.
- 'I didn't realise that'human' insulin was not derived from humans'.
Insulin analogues are artificial derivatives of the natural hormone insulin and are designed to have different absorption profiles compared to GM insulins and natural animal insulins. Their long-term safety is unknown and they have the potential for carcinogenic effects.
A report prepared by an international group of physicians and people with diabetes entitled "The need to enable people requiring insulin to have an informed choice of insulin treatment" and supported by the Rockefeller Foundation, New York, USA.
For the full report and scientific supporting information link to http://www.iddtinternational.org/reviewsandreports/index.htm#BELLAGIO_REPORT_1996.
Living with diabetes not only affects the life of the person with diabetes but also other family members because of lifestyle changes that are involved and emergency situations that may occur, such as hypoglycaemia [low blood sugars] where assistance is required. It can be a stressful situation for family carers especially as they are often not involved in the education and treatment visits to diabetes clinics. IDDT believes that there should be greater involvement of family carers in the treatment and care of people with diabetes as this would assist them. Family carers may also have a valuable input to consultation.
Further information about complications link to http://www.iddtinternational.org/parentsandcarers/carers.htm
Children and young people with diabetes
Living with diabetes is difficult for children and especially so for teenagers. It is worrying and stressful for parents who have to try to achieve a balance between trying to maintain good diabetic control with a good quality of life for their child/teenager but also looking to the future to try to prevent or delay the long term complications. This is not easy in children and especially teenagers. For more information link to http://www.iddtinternational.org/parentsandcarers/parents.htm
Cochrane Review of 'human' and animal insulin, July 2002
This 'gold standard' review has provided evidence that 'human' insulin is not superior to animal insulin but most importantly, has found that most of the studies that were carried out were of 'poor methodological quality'. Further more many patient related issues have never been investigated including patient satisfaction, health related quality of life or diabetes complications and mortality and only 40% of the studies provided any information about adverse reactions and then only those related to hypoglycaemia. The lack of research into these issues and the poor quality of the majority of the research that was carried out, is of great concern to people with diabetes because the synthetic insulin they are taking could be more causing more harm than previously used the natural animal insulins which have a proven record of safety and efficacy and a well documented history of any adverse reactions.
People with diabetes are at risk of developing complications. Research has shown that maintaining blood glucose levels with the normal range reduces the risks of complications but this also increases the risks of severe hypoglycaemia threefold.
Further information about complications link to http://www.iddtinternational.org/facts/index.htm
Crime and diabetes
People that have hypoglycaemia [low blood glucose levels] and do not have any warnings of this impending attack, can continue to function in an automaton state without being aware of what they are doing. Research has shown that this state has lead to crimes of all kinds being committed. For more information link to link to http://www.iddtinternational.org/healthissues/hypoglycaemia.htm
Dead in bed syndrome
Also called sudden unexplained deaths, these deaths are estimated to occur in 6% of all deaths in people with diabetes under the age of 40 and are more common in young people, especially those living alone. There are particular circumstances that surround the deaths - the person is found dead in an undisturbed bed and they appeared to be in good health before going to bed. The cause of death is thought to be hypoglycaemia and these deaths have been associated with the use of'human' insulin.
Diet and weight
The three cornerstones of the treatment of Type 1 diabetes are insulin, diet and exercise. The present dietary guidelines for people with diabetes are similar to the healthy eating recommendations for the general public. There are other views and experiences.
For further information link to http://www.iddtinternational.org/healthissues/weight.htm
Dream Trust is a clinic in Nagpur that cares for underpriviledged children with diabetes. IDDT supports the Dream Trust with regular supplies of unwanted insulin and other diabetes supplies.
Driving and diabetes
People with diabetes are entitled to a medically restricted driving licence for a maximum of 3 years. The main reasons for withdrawal of a driving licence is loss of warnings of hypoglycaemia and/or visual difficulties usually caused by retinopathy. People with diabetes are recommended to test their blood glucose levels before driving.
For further information link to http://www.iddtinternational.org/livingwithdiabetes/drivingwithdiabetes.htm
Exercise is an important part of maintaining diabetic control but in addition people with diabetes are at a significantly greater risk of heart disease and stroke than the general population.
Physical activity halves the risk of developing coronary heart disease. Physical activity reduces the risk of having a stroke, helps to lower blood pressure.
For further information link to http://www.iddtinternational.org/healthissues/exercise.htm
Eyes and diabetes
Diabetes is the single largest cause of blindness in the working population. It is mainly caused by diabetic retinopathy, leaking of the blood vessels at the back of the eye. Regular screening of the eyes can detect early signs of retinopathy and laser treatment can help to delay or prevent further damage. For further information link to http://www.iddtinternational.org/healthissues/eyes.htm
'The GM Injection', Daily Mail 20.8.02
This is the title of an article published in the Daily Mail. It is a well balanced article that describes the development of 'human' insulin by genetic modification from e-coli or yeast. It not only highlights the adverse reactions that people have experienced, the sad cases of 'dead in bed' syndrome but also provides information that raises serious questions about the way in which synthetic insulin was introduced and the involvement of some experts and diabetes organisations. It makes chilling reading. It resulted in several hundred telephone calls to IDDT from people suffering similar effects but who never thought that the insulin they are using could be responsible and who had never been given an informed choice of insulin treatment.
History of the development of genetically produced 'human' insulin
For a short account of the development of 'human' insulin link to http://www.iddtinternational.org/gmvsanimalinsulin/index.htm
In people without diabetes the level of glucose in the blood is controlled by insulin produced be the beta cells in the pancreas. This prevents the level of glucose in the blood from rising too high. In people with Type 1 diabetes, the body does not produce its own insulin and the blood glucose levels rise too high [called hyperglycaemia] and so injections of insulin are given to prevent this.
If the blood glucose levels drop below normal, then this is called hypoglycaemia.'Good' control of diabetes is avoidance of both high and low blood glucose levels. Hypoglycaemia is a complication of insulin treatment and is the complication that causes people the most concern on a daily basis.
Hypoglycaemic unawareness or loss of warnings is where the usual warnings signs/symptoms of the impending'hypo' are not present. The avoidance of hypoglycaemia is an acute daily problem for people with diabetes but when accompanied by loss or partial loss of warnings, it can have a dramatic effect on the lives of both the person with diabetes and their families. Loss of warnings of hypoglycaemia may result in the following:
- A feeling of insecurity and loss of independence.
- A fear of leaving the home.
- Being a danger to oneself and others.
- Aggressive or violent behaviour.
- Family conflict, breakdown of relationships.
- Loss of driving licence - it is illegal to drive with loss of warnings.
- Loss of job
- A deliberate raising of blood glucose levels to avoid such situations.
For further information link to http://www.iddtinternational.org/healthissues/hypoglycaemia.htm
People in countries around the world experience adverse reactions to'human' insulin and they have been brought together under the umbrella of IDDT- International to unite in their attempts to preserve the animal insulins they need. Health systems and availability of insulins vary from country to country and so we have websites for the countries in which the trust has branches - Australia, Canada, Finland, Germany, Switzerland and the USA.
For further information link to http://www.iddtinternational.org/
There is a choice of injection devices:
- disposable syringes used with vials of insulin
- injection pen devices used with cartridges of insulin
- disposable pre-filled injection pens
Syringes and most pen devices and insulin are available free on the NHS but the same insulin in cartridges for pens cost more per unit than in vials and costs even more in disposable pens.
In the Dept of Health consultation process about pre-filled disposable pen devices being available free on the NHS, IDDT expressed the view that this was an unnecessary expense to the NHS except for people with hand movements difficulties who could be prescribed it on a named patient basis. This view was not accepted.
Insulin pumps are small devices that pump a continuous flow of insulin into the body through a small tube inserted under the skin of the stomach. They are used by a small minority of people although interest is increasing. They are expensive to purchase and expensive to run and not generally available free on the NHS and this is dependent on the local health authority.
Insulin is a hormone produced by the pancreas and it's function is to help the body utilise glucose to provide the energy the body needs. Glucose mainly comes from the food we eat and after being digested it goes into the bloodstream. Insulin allows the glucose in the blood to pass into the body cells where it can be used for energy.
In Type 1 diabetes the pancreas produces little or no insulin and so insulin has to be injected regularly to prevent the levels of glucose in the blood rising. Insulin cannot be taken by mouth because it is a protein and broken down by the digestive system.
There are three sources of insulin - natural animal insulin, synthetic'human' insulin and synthetic analogue insulin. All insulins are highly purified and there is no evidence that the synthetic insulins have any clinical benefits for patients over natural animal insulins. The different types of insulin can react differently in different people and therefore the insulins used and the injection regime should be tailored to individual needs.
For practical information about insulin Link to http://www.iddtinternational.org/livingwithdiabetes/lookingafteryourinsulin.htm
IDDT's quarterly newsletters with up to date diabetes related issues
Synthetic human insulin:
Novo Nordisk Pharmaceuticals Ltd
Eli Lilly and Co Ltd
CP Pharmaceuticals Ltd
Novo Nordisk Pharmaceuticals Ltd
CP Pharmaceuticals Ltd
International Diabetes Federation [IDF]
This is an international organisation that represents the interests of people with diabetes throughout the world. IDDT put forward a submission to be considered by the IDF Executive Board, April 2002, to request their support to maintain animal insulins for people that require them on both health and economic grounds.
Summary of IDDT Recommendations to the IDF
The IDF should make recommendations to support the needs of patients and these should be put in the public domain and also sent to diabetes associations and organisations of the medical and nursing professions:
(i) condemning the dominant position of the major insulin producers whereby people with diabetes and are suffering and dying as a result of their commercial decisions.
(ii) expressing the view that patients' needs are paramount and patients' right to an informed choice of treatment is an essential and integral part of best practice.
(iii) that animal insulins should remain available throughout the world for the people that need them for whatever reason whether these be on the grounds of economics or clinical need.
Insulin Dependent Diabetes Trust-International
IDDT aims to help and support people with diabetes and so the research that we support favours that with potential benefits for the average every day diabetic patient (if there is such a thing!).
IDDT is not against any research that might question generally accepted principals in diabetes care, providing it is reasonable and does not potentially put patients' health or wellbeing at risk. The Trust would particularly support new ways of thinking and treating diabetes especially when consumer input and consumer experience is put as a key aspect of the research.
At this stage IDDT is prepared to consider applications for research in the area of primary care up to £10,000 for any one project but is happy to consider joint funding.
For further information contact:
Beverley Sharpe, Research Facilitator, IDDT, PO Box 294, Northampton NN1 4XS
Travelling with insulin and injection devices since September 11th
As a result of the increased security at airports and on flights following, there are to be no sharp objects in hand luggage. This clearly affects people requiring insulin because syringes, pen injection devices and blood testing lancets are all sharp objects and therefore fit into this category. Airports and airlines have recognised the need for people with diabetes to inject on flights and special regulations have been made to enable them to take the necessary equipment on board the aircraft.
For general advice on travel and holidays link to http://www.iddtinternational.org/livingwithdiabetes/holidayandtravel.htm
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