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| IDDT an Introduction |
IDDT is a UK organization set up in 1994 to help
and support people with diabetes who need natural
animal insulins. This sub-group of people with diabetes
cannot use synthetic so called ‘human’
insulin because of adverse effects on their health
and quality of life. The aims of the Trust are:
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To try to ensure that natural
animal insulins remain available for the people
that need them.
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To provide information about
the availability of animal insulins.
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To seek recognition of the difficulties
that a significant minority of people have when
they are treated with synthetic ‘human’ insulin.
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To represent and lobby on behalf
of this group of people to ensure that they have
the natural animal insulin they need to retain
good health and a good quality of life.
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| IDDT - India |
The recent withdrawals
of animal insulins by the major multi-national insulin
manufacturers has led to the formation of IDDT-India.
Co-chairman
of IDDT-International Dr. Matthew Kiln and Mrs. Jenny
Hirst say:
Our concerns are that natural animal insulins are being discontinued
by the multi-national insulin manufacturers in favour of
GM synthetic 'human' insulins without any evidence that these
are superior to natural bovine and pork insulins. Our experience
in the UK and other countries is that a significant number
of people have adverse reactions to synthetic 'human' insulin
and therefore need natural animal insulins. The most common
adverse effect is an increase in hypoglycaemia.
"IDDT relies
entirely on voluntary donations, so please help by
making a tax efficient donation through our secure
online service." |
| THE CONCERNS OF PEOPLE WITH DIABETES ARE JUSTIFIED |
While the evidence from patients of side effects when using ‘human' insulin may be dismissed, IDDT has gathered the following statements that support the concerns of patients: |
| British National Formulary [BNF] states: |
Preparations of human sequence of insulin should theoretically be less immunogenic, but in trials no real advantage has been shown ….Some patients have reported loss of warnings of hypoglycaemia after transfer to human insulin. Patients should be warned of this possibility and if they believe that human insulin is responsible for their loss of warnings it is reasonable to transfer them back to porcine insulins. When prescribing insulin great care should be taken to specify whether a human or an animal insulin is required. Indications for changing from animal to human preparations must be carefully considered in the light of these reported problems. |
| Drug and Therapeutics Bulletin, March 1989, |
This government sponsored safety bulletin, reported that ‘human' insulin is no better than conventional insulin treatment and may hold dangers for people with diabetes. The Bulletin also said that ‘human' insulin may cause loss of early warning symptoms of hypoglycaemia. (The Bulletin has continued to maintain this stance.) |
| Food and Drug Administration [FDA] Patient Information Leaflet |
The warning in these leaflets in bold type in the insulin packs says:
“A few patients who have transferred from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less pronounced or different.” |
| US Report of Post Market Adverse Drug Effects,1995, FDA |
The 1995 table for reported post-market adverse drug effects in the US shows the top 10 suspect drugs. Humulin, ‘human' insulin produced by Eli Lilly, is ranked number eight and is one of only three non-prescription drugs to be on this list. The Medicines Control Agency in the UK does not make public their reported adverse drug reactions. |
| Committee on Safety of Medicines (CSM), August 19 th 1998 |
“The CSM concluded that some patients did experience problems with human insulins, particularly when initially transferred from animal insulins and were better suited to continuing their treatment with animal insulins. However, the CSM no evidence of a safety problem specific to human insulin. Indeed most patients respond well on it…. To ensure that patients continue to have a choice of treatment both animal and human insulin will remain available.” |
| Recent Press Statements from insulin manufacturers: |
Sept 9 th 1999 , Novo Nordisk : “…..Historically improving glycaemic control with soluble human insulin has been associated with an increased risk of hypoglycaemia.”
April 24 th 2000 , Aventis Pharmaceuticals : “Human insulin therapy may be associated with hypoglycaemia, worsening of diabetic retinopathy, lipodystrophy, skin reactions (such as injection-site reaction, pruritus, and rash), allergic reactions, sodium retention and oedema.”
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