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Insulin
Dependent
Diabetes
Trust
Synthetic GM ‘human’
insulin versus natural animal insulin
Animal derived insulins have
been used to treat people with diabetes since insulin was first
discovered and since the 1970s it has been highly purified. Genetically
produced so-called ‘human’ insulin was introduced in 1982 and now the
vast majority of people requiring insulin treatment are prescribed
synthetic GM ‘human’ insulin or their successors, insulin analogues.
However, after 20years there is still no evidence that synthetic GM
insulins have any clinical advantages for patients and they cost the NHS
significantly more than animal insulins.
A significant minority of people experience adverse reactions when
treated with synthetic insulin and these adverse reactions often
disappear with a change to natural animal insulin. The adverse reactions
affect the ability to satisfactorily control blood glucose levels, the
ability to recognise low blood glucose levels [hypoglycaemia] so
preventing remedial action being taken so increasing the risk of coma
and even death. The other reported adverse reactions include a clearly
defined of category of symptoms - large weight increase, extreme
tiredness, memory loss, behavioural changes, joint and muscle pains.
Many patients that have reported adverse reactions have not been
believed by their doctor and/or healthcare professionals.
People are rarely given a choice of insulin treatment with information
about risks and benefits and so are denied the informed choice of
treatment to which they are entitled. For no good clinical reason, some
patients are even denied their request to be transferred to animal
insulin while others are given misinformation about the claimed
superiority of ‘human’ insulin and the lack of availability of animal
insulin.
‘Human’ insulin was originally thought to have advantages over natural
animal insulin but research has since demonstrated that it has no
clinical advantages for patients over animal insulin and there is no
long-term safety data. The Patient Information Leaflets and the
Medicines Control Agency confirm that a small number of people are more
suited to treatment with animal insulin. Despite this the major insulin
producing companies are systematically discontinuing animal insulins
from countries in Europe and the rest of the world and it has been
confirmed that this is their intention in the UK. This will leave people
that need animal insulin without the treatment that they know from
experience suits them best and the treatment they need to maintain their
health and quality of life.
Discontinuation of animal insulin has already happened in most EU
countries - it is likely to happen in the UK unless we ACT NOW!
Campaign Aims:
-
full recognition of the adverse effects of ‘human’ insulin in some people
-
an indefinite availability of pork and beef insulins to suit the needs of ALL people requiring insulin therapy
-
that all people receiving insulin treatment are given an informed choice of treatment, including the risks and benefits of ALL types of insulin.
FACTS
-
Discontinuation of animal insulins is for commercial reasons and this means that insulin treatment choices are being dictated by pharmaceutical companies and NOT the medical profession or patient need.
-
Animal insulins have been used safely and effectively for over 70years. There is no evidence to show that synthetic GM 'human' insulins are better than animal insulins [Cochrane Review 2003]
-
Comparison of regular 'human' insulin and short-acting insulin analogues showed only minor benefit with analogues in some people [Cochrane Review, May 2004] but due to fears of potentially carcinogenic and proliferative effects, most studies to date have excluded patients with advanced diabetic complications.
-
Both Cochrane reviews showed that majority of this research to compare the above insulins was 'methodologically poor' and importantly for patients, there has been no research to compare patient-oriented outcomes such as mortality and complication rates and quality of life [Cochrane Reviews 2003 and 2004].
CAMPAIGN UPDATE
Thank you to everyone who has written and re-written to their MPs and
MEPs about Novo Nordisk's possible discontinuation of animal insulin.
Your help has been invaluable in the campaign and has given credibility
and support to the many Westminster meetings the Trustees have had with
MPs of all parties. IDDT is also very grateful to the many MPs and MEPs
for their understanding and support and for taking up the issues in the
House of Commons, directly with the Minister of Health and with the
insulin manufacturers.
Understandably many people have felt angry and frustrated at some of the
replies your MPs have received from Rosie Winterton, Minister of Health,
and Lord Warner, the Under Secretary of State for Health. But by
continuing to respond through your MP, you are putting our case more
strongly and sending the message that we are not going to be fobbed off
with half-truths and spin on the evidence.
The campaign achievements so far:
Parliamentary Questions
Over 30 Parliamentary Questions have been asked of the Minister of
Health, Rosie Winterton. One of the many supportive MPs, Tim Loughton,
has been very supportive and asked many PQs on our behalf and is to
pursue the following points:
(a) Government research into comparing animal and synthetic insulins
(b) Why doctors are not giving patients a fully informed choice of
insulins
(c) Why the NHS is paying more for synthetic insulins that are not
superior to animal insulins for the majority of patients
(d) That there must be a better education programme for people with
diabetes and this MUST include patients being given a fully informed
choice of ALL insulins.
Novo Nordisk agree some people can't tolerate GM insulin and delay
their decision
Novo Nordisk has agreed to delay their final decision about future
availability of animal insulin until summer 2005 so supplies should
continue until the end of 2006 or into 2007. In a statement from their
Chief Executive in the UK, Novo Nordisk have acknowledged that some
people can't tolerate synthetic insulin and the importance of this
statement must not be underestimated. "The company is aware that
there are people with diabetes who are only able to tolerate animal
insulins."
It has taken 20years and pressure from you and your MPs to achieve this
acknowledgement and the importance of this statement must not be
underestimated:
-
It directly supports our lobbying for the indefinite supply of animal insulin for the people "who are only able to tolerate animal insulin". With a statement like this, if the government doesn’t ensure continued supplies, they are knowingly condemning people to a treatment they can't tolerate and this is an unthinkable position.
-
It questions the safety and medical ethics of transferring patients "who are only able to tolerate animal insulin" to any synthetic GM insulin, including insulin analogues.
-
It leaves doctors who prescribe any of the synthetic insulins to patients "only able to tolerate animal insulin" in a very vulnerable and unenviable position, a similar position to prescribing penicillin for a patient known to be allergic to it.
Meeting
with Dept of Health civil servants, May 2004
IDDT expressed our concerns that CP Pharmaceuticals, the other animal
insulin manufacturer in the UK, may not be able to meet the increased
demand for pork insulin should Novo Nordisk decide to discontinue their
pork insulin. This was discussed at a meeting with the Dept of Health in
May and since then Lord Warner has stated:
"CP have given assurances that it currently has no plans to stop the
supply of animal insulin. CP have confirmed to the Dept officials that
they could meet any increased demand for animal insulin within a maximum
of three to four months."
Through their MPs IDDT members persisted in expressing their concerns
about only having one supplier and in August 2004 Lord Warner made the
following statement:
"Should one of the two companies supplying animal insulin in the UK
decide to withdraw their product, the Dept of Health will take whatever
steps are necessary to help ensure that patients continue to receive the
treatment they need."
This undoubtedly is progress. It answers goes some way to answer the key
question we asked the Dept of Health about who is responsible for
ensuring that UK citizens have the essential medicines they require.
Lord Warner certainly suggests that the Dept of Health is responsible
but what does he mean by 'treatment'? All insulins lower blood glucose
levels and simply lowering blood sugars could be classed as the
treatment so we need greater clarification as follows:
-
We need a categorical statement that this promised treatment will in fact be with animal insulin. We cannot risk that this decision will be in the hands of the doctors and nurses who have never believed that there are adverse reactions to synthetic GM insulin. We need to be categorically assured that we, as patients, will be actively involved in this decision and that this will not be a battleground where patients have to be assertive to continue to receive animal insulin.
-
We need to be assured that animal insulins remain available as a choice of treatment for everyone requiring insulin. The phrase "patients continue to receive the treatment they need" suggests that all the Department will do is ensure those already using animal insulin will continue to receive it. This is not good enough. IDDT continues to receive new reports of adverse reactions with 'human' insulin and with all the new analogues and if animal insulins are not freely available now and in the future, these people will be forced to remain on a type of insulin that adversely affects their health and lives.
-
Animal insulin must remain available now and in the future and for everyone, not just for those presently using it.
-
We need steps to be taken to ensure that everyone requiring insulin is made fully aware that animal insulin is available and that synthetic GM insulins do cause adverse reactions in some people. It is essential that this is done by hospital clinics and not by a charity.
Adjournment Debate, November 16th 2004
David Amess MP led an Adjournment Debate on Diabetes and requested
assurances about future supplies of animal insulin. Dr Stephen Ladyman,
Parliamentary Under-secretary of State for Health responded for the
Government with: "Were we to become aware of such plans [to
discontinue], we would, of course, express a view, and our clear view is
that which type of insulin a patient receives should be a clinical
decision. That decision certainly should not be controlled by commercial
considerations or issues of availability."
Meeting with the
Minister, December 7th 2004
David Hinchliffe MP, Chairman of the Health Select Committee requested a
meeting for IDDT with the Minister of Health, Rosie Winterton and she
agreed to meet with us. The Minister:
[i] supported the statement made by Dr Ladyman that choice of insulin
treatment should not be dictated by commercial considerations or
availability.
[ii] agreed to look into the ability of CP Pharmaceuticals to meet the
increased demand for animal insulin in the event that Novo Nordisk
decides to discontinue production, especially in the light of their
recent out-of-stock position.
[iii] agreed patients must have an informed choice of treatment and
steps would be taken, such to try to ensure that both patients and
healthcare professionals are made aware of the availability of animal
insulin eg information on the Dept of Health website. IDDT made the
point that this information should be full and complete and include the
fact that both 'human and analogue insulins have the potential for
carcinogenic effects with analogues having the greater potential, and
that animal insulins have no such effects.
We are making progress and it is encouraging that we now have
supportive MPs who clearly recognise that some people cannot tolerate
synthetic insulins. Like many of us, they see the unfairness and the
risks associated with denying people the insulin they need and they have
difficulty in finding an explanation, especially when a known 30,000
people is not an in significant number.
We ask everyone who cares about people with diabetes to join our
campaign to ensure that the choice of natural animal insulins remain
available for the people who need it and cannot tolerate the only
alternative -synthetic GM insulin. But our campaign has wider
implications as it clearly demonstrates that it is the very powerful
pharmaceutical industry that can dictate treatment choices irrespective
of doctors and patients' needs and wishes.
Discontinuation of animal insulin has
already happened in most EU countries - it is likely to happen in the UK
unless we ACT NOW!
PLEASE HELP!
If you would like
further information and a lobbying pack to help by contacting your
elected representative, contact Jenny Hirst,
e-mail
lobbying@iddtinternational.org.
Telephone 01604 622837 or write to: IDDT, PO Box 294, Northampton NN1
4XS