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Insulin
Dependent
Diabetes
Trust
.
News Releases
PRESS RELEASE
30 years of synthetic insulin – are patients getting a good deal?
LAUNCH CONFERENCE REPORT
At their annual conference today, The Insulin Dependent Diabetes Trust (IDDT)
launched their report “30 years of synthetic insulin – are people with
diabetes getting the best deal?” The Report researches the 30-year
history of synthetic insulins and highlights their increasing cost to
the heath service today. It also highlights patients’ concerns over the
lack of choice, information and support from their clinicians and
questions the safety of modern day insulins.
Jenny Hirst, Chair of IDDT commented, “2007 is the 30th Anniversary of
synthetic insulins but we see no reason to celebrate. The NHS is paying
increasingly extortionate amounts for these insulins and yet there is no
evidence to suggest that these modern day insulins are any more
effective than human or animal insulins. In fact, in some cases there is
research that shows that they may even have carcinogenic properties.”
IDDT, which was set up in 1994 to champion the interests of patients
with insulin dependent diabetes, has been studying the research on the
effect of these synthetic insulins and is concerned that over 30,000
people are experiencing serious adverse effects when using then.
The IDDT Helpline is inundated with worried patients and family carers
who just want answers to why their symptoms are so serious, and why they
are unable to manage their diabetes effectively.
A recent report¹ by Professor Edwin Gale et al, also questions whether
people with diabetes are getting the best deal. “When the choice is
between treating 150-200 patients with long-acting analogues instead of
‘human’ insulin or employing a full-time nurse specialist educator at
the same cost – which would be best for patient care?” The IDDT
knows that children with diabetes are receiving suboptimal care, and
primary care trusts (PCTs) are unable to fund educational programmes,
enough diabetes specialist nurses, or provide essential self testing
strips for diabetic patients, so it is shocking that PCT budgets are
being consumed by ever-increasing insulin costs that provide little
benefit to patents.
Iain Chalmers, (Co-ordinator, James Lind Initiative) added, “no
substantial advantages of human over animal insulin have ever been
shown, or of analogue insulin over human insulin. So why has the NHS
acquiesced in paying insulin manufacturers millions of pounds more than
they need to, to buy the newer insulins? As someone who believes that
evidence should inform practice (and as a taxpayer), it seems to me that
NICE should show these wasted NHS resources can be used to help people
with diabetes more effectively.”
A recent Early Day Motion on the issue² gathered over 100 signatories of
cross-party support and many more MPs offered their support by writing
to Ministers.
Finally, Jenny Hirst commented, “we would like to see a complete
overhaul of the insulin market and we are calling for the NICE to review
all the insulins in the marketplace today in order to research their
clinical and cost
effectiveness.
¹ Nice Insulins, pity about the
evidence. Diabetologiia (2007) 50;1783-1790. Holleman F, Gale Eem.
² Early Day Motion
THREAT TO SUPPLY OF ANIMAL INSULIN
That this House congratulates Wockhardt Pharmaceuticals on the expansion
of production facilities for animal insulins to cope with increased
demand as a result of Novo Nordisk Pharmaceutical's discontinuation of
their pork insulin and thanks the Minister of State, the Honourable
Member for Leigh, for his Department's role in ensuring that animal
insulins continue to be available for those people who need them, but
regrets that Novo Nordisk
Pharmaceutical has begun a systematic discontinuation of their synthetic
'human' insulin products in favour of insulin analogues further reducing
patient and physician choice; expresses grave reservations that many
patients are being transferred to insulin analogues before their
long-term safety has been established and before studies
recommended by the European Agency for the Evaluation of Medical
Products have been carried out to investigate the potential for
carcinogenic effects of insulin analogues; and therefore requests that
the Secretary of State for Health asks NICE to assess the safety,
clinical and cost effectiveness of all insulins to provide patients and
clinicians with the necessary information to make informed treatment
choices.
IDDT TRIUMPHS IN AUSTRALIA
The Insulin Dependent Diabetes Trust (IDDT) - after many years of lobbying - has at last succeeded in facilitating supplies of pork insulin into Australia. Previously, people with diabetes in Australia who wished to use porcine animal insulin were forced to import it via the UK, but with the intervention of IDDT, pork insulin is now available from Aspen Pharmacare Australia.
IDDT Chair, Jenny Hirst commented, ‘We are so pleased that at last people in Australia have choice. This has taken years of lobbying and although in the past it was possible for Australians to import some animal insulins from the UK, this proved to be extremely problematic. This was largely because insulin doesn’t travel well in high temperatures and is adversely affected, and the cost of importation was extremely high.
Although the pork insulin (Hypurin Porcine) is not a registered product it is available through a government Special Access Scheme (SAS) on a case-by-case basis. It is a Category B product and applications for its supply can be made by registered medical practitioners.
In order to make the supply as simple and fast as possible for both patients and healthcare professionals, Aspen Pharmacare have prepared very clear instructions on how to order Hypurin Porcine Insulin with prices and SAS forms, all of which are available by telephone, fax or on their website (details below).
Notes to Editors
For further information
on the supply of pork insulin in Australia, please contact:
Aspen Pharmacare:
Telephone: 02 8436 8300
Fax: 02 9901 3540
www.aspenpharma.com.au
or Ian Kershaw, IDDT Australia:
Telephone 03
6334 7552 or
iddta@aapt.net.au
Press Contact:
Veronica Wray (London,
UK)
0011 44 20 8568 8546 or 0011 44 7710 624454
veronicawray@aol.com
In sickness
and in health: diabetic treatments need an injection of common sense
Sunday Telegraph, 31.10.04
By James Le Fanu
Animal insulins can suit diabetic patients far better than human
insulin, says Dr James Le Fanu
Medicine is, for the most part, a sane and scientific enterprise but it
can be surprisingly intolerant of even the most well-intentioned
criticism.
Thus, some of those with diabetes find that modern regimes of treatment
can cause, perhaps paradoxically, severe problems - but their
difficulties have fallen on deaf ears, with serious implications.
Since the discovery of the life-saving potential of insulin in 1921,
diabetics have successfully controlled the level of sugar in their blood
by regularly injecting themselves with the hormone, derived from pigs
and cows. This is cheap, plentiful and highly effective.
Then, in the early 1980s, scientists managed to produce human insulin by
the revolutionary process of genetic engineering. They inserted the
relevant gene into a bacterium that reproduced billions of times,
producing the hormone in prodigious quantities.
In practical terms, the chemistry of human insulin is virtually
identical to the animal varieties, but it seemed obvious that the human
form must be "better" and doctors accordingly advised their patients
that they should switch.
Some found, quite unexpectedly, that their previously well-controlled
diabetes suddenly went haywire, as the levels of sugar in the blood
oscillated wildly. Matthew Kiln, a family doctor, found that he could no
longer anticipate the potentially serious state when his blood sugar
fell too low - known as a "hypo" - which must be promptly corrected
before coma supervenes. His personality changed, too, and he became
uncharacteristically more irritable and argumentative, with unfortunate
consequences for his personal and professional life.
Surveys revealed that about one in four diabetics were experiencing
similar difficulties. No one could come up with a satisfactory
explanation but most were able, albeit with some difficulty, to persuade
their doctors to do the sensible thing and switch them back to the
animal-based insulins.
Dr Kiln and his contemporaries had realised that there was something
wrong because they knew, from personal experience, how the control of
their diabetes had deteriorated. This opportunity is, however, denied to
those who have come after them, and who are routinely started on the
genetically engineered human form.
No doubt, this works for many but certainly not for all, as revealed by
the experience of another doctor-cum-diabetic, Ann Robinson, a
46-year-old psychiatrist.
Dr Robinson discovered that she had diabetes a couple of years ago, but
expected to be back at work in no time. Her human insulin injections, as
intended, kept the levels of sugar in her blood within the normal range,
but she felt terrible. "I did not feel like me with an illness. I felt
like someone else," she says. "I became a zombie. I could not
concentrate for more than a few minutes and, whenever I took the least
exercise such as going for a walk, my blood sugar went right through the
floor."
The months went by and her perplexed consultant changed Dr Robinson's
regime of injections no less than five times, but to no avail. She
realised eventually that there was no alternative but to take early
retirement on medical grounds.
Then, one evening in July, while idly flipping through a medical
journal, she chanced upon an article by Dr Kiln that rang a peal of
bells with her. She rushed round to her family doctor, brandishing Dr
Kiln's article, and persuaded him to switch her from human to pig
insulin. Within a couple of days, her life changed.
"I woke feeling hungry for the first time in two years," she says, as
if, once again, her body's metabolism was working as it should. Her
intellect emerged from the twilight as she found she could concentrate
once more, her joints loosened up and her personality returned. "I was
me again," she says.
Dr Robinson wonders how many others there are like her: children, for
example, whose behavioural and learning problems are blamed on their
reaction to being diagnosed as having diabetes, but who will become
their sunny selves again simply by switching to pig insulin. But how are
they (or their parents) to know?
And there's the rub. Ten years ago, Dr Kiln helped set up the Insulin
Dependent Diabetes Trust to promote research and publicise this
important issue - but, astonishingly, no one really seems to want to
know. It is scarcely revolutionary to propose that some of those with
diabetes might do better with animal-based insulins - but, for many and
complex reasons, neither the diabetes specialists nor the drug companies
are prepared to give them a sympathetic hearing.
Indeed, it remains an uphill struggle to ensure that the animal insulins
are even available. This is perhaps not unrelated to the fact that they
are far less profitable to the drug companies than the much more
expensive human forms. Enough said.
The IDDT can be contacted at PO Box 294, Northampton, NN1 4XF; 01604
622837; For more information on IDDT
please click here.
Lilly withdraw 4 'human' insulins in
the UK - with very little notice
Issued by The Insulin Dependent Diabetes Trust - International
MARCH, 2004
Eli Lilly have announced that they are to discontinue supplying the following insulins:
-
Humulin M2 cartridges by the end of April 2004
-
Humulin M% vials by the end of July 2004
-
Humulin Zn vials by the end of July 2004
-
Humulin lente vials by the end of July 2004
Lilly is informing pharmacists, diabetes centres, GPs and healthcare professionals throughout the UK of these discontinuations and the alternatives that are available.
If you are using any of these insulins that are being discontinued, then IDDT recommends that you make an immediate appointment with your diabetes clinic to discuss the alternative insulins available to you. Remember with any change of insulin, it is important to monitor blood glucose levels more frequently.
World Diabetes Day – a call for insulin
research
Issued by The Insulin Dependent Diabetes Trust - International
NOVEMBER 11, 2002
FOR people with diabetes using insulin treatment, loss of warnings of low blood sugars (hypoglycaemia) has a damaging effect on their lives.
It can lead to coma and even death. This loss of warnings can be one of the adverse reactions that many people experience when using genetically modified [GM] insulin. They may find that these difficulties regress if they switch to traditional natural animal insulin derived from pancreases of pigs or cattle.
Other adverse reactions are extreme tiredness, sleeping all the time, large weight increase, memory loss or confusion, erratic blood glucose levels, joint pains or behavioural changes ('not the same person').
According to the Insulin Dependent Diabetes Trust-International (IDDT), these adverse reaction reports are growing all the time and people with diabetes have reported a dramatic improvement in their health once their insulin was changed to natural animal sourced products.
And, to mark World Diabetes Day (November 14, 2002), IDDT-International is calling for follow-up of high quality randomised clinical trials of different insulin types to take into account patient-oriented outcomes such as health-related quality of life, diabetes complications and mortality.
These issues were never investigated in earlier randomised clinical trials comparing animal with 'human' insulin, produced from genetically modified e-coli or yeast, first introduced in 1982. (see the Cochrane Review July 2002 http://www.update-software.com)
Jenny Hirst, co-chairperson of IDDT said: "It is essential that people with diabetes and health authorities throughout the world can make informed choices about insulin treatment, taking into account both health and economic issues.
"This is especially important in developing countries to enable health authorities to be in an informed position to negotiate with insulin producers for the needs of their diabetic communities, especially in view of the higher cost of GM 'human' insulin."
Contact details:
Jenny Hirst
Insulin Dependent Diabetes Trust
PO Box 294
Northampton
NN1 4XS
Tel 01604 622837 Fax 01604 622838 e-mail enquiries@iddtinternational.org
website www.iddtinternational.org
Background Information
About insulin: in the past, everyone requiring insulin treatment used highly purified natural animal insulin derived from the pancreases of pigs and cattle. Once genetically modified insulin appeared on the market in 1982, it came into general use on the assumption that it was better than animal insulin, although there never was any scientific evidence to demonstrate this.
In the late 1980s, a significant number of patients began reporting adverse reactions to the GM products, which largely disappeared with a change to animal insulin. In 1995, 'human insulin' was eighth on the list of adverse events compiled by the FDA, the United States regulatory organisation.
About Diabetes
Diabetes is a chronic disease and there are two forms.
Type 1 is diagnosed as an acute condition, and is caused by the body's immune system attacking insulin-producing cells in the pancreas. As a result, the body no longer produces insulin, glucose levels rise, and treatment with insulin injections is always required for survival.
Type 2 In this type of diabetes, the pancreas still produces some insulin but this is not utilised properly by he body. Treatment can be diet and exercise alone or oral blood glucose lowering drugs but insulin is required if blood glucose levels are not sufficiently reduced.
About IDDT
The Trust originally was a United Kingdom-based charity set up in 1994
to help and support people who react adversely to so-called (GM
produced) 'human' insulin; it seeks to ensure that natural animal
supplies remain available indefinitely and that people with diabetes
receive information and choice of available insulin treatments.
The Trust also collects unopened 'in date' insulin and sends this to help people in need in developing countries.
(It is funded entirely by voluntary donations, is independent, and free of influences from any quarter.)
IDDT’s Position Statement on DTCA
Issued April 2002
Provision of information to consumers by pharmaceutical companies
The Insulin Dependent Diabetes Trust [IDDT] is an international patient organisation for people that live with diabetes. In order to function in the best interests of this consumer group without any conflicts of interest, we have a stated policy that we will not accept any funding from the pharmaceutical industry, unlike many other diabetes organisations.
We are totally opposed to the proposal that the pharmaceutical industry should be allowed to supply disease-related information directly to consumers and to any movement towards DTCA. While we accept that there may be a need for consumers to have more information about prescription drugs in language they can understand, we strongly believe that both this and information about the condition being treated should be as unbiased as possible. Therefore it is inappropriate that it should be provided by the pharmaceutical industry whose understandable aim, is profit.
The ability for consumers to obtain independent information is already threatened by:
-
Industry funded research and conflicts of interest and prestigious research institutions receiving industry funding, so blurring the relationship between research and commercial gain.
-
Preparation of clinical guidelines, an article in JAMA, February 2002, finding that 90% of the authors received funding from or acted as consultants to drug companies
-
‘Fast track’ approval of drugs coupled with ADR reporting systems being grossly underused. In diabetes, troglitazone highlighted this situation when at least 92 people died and many others were damaged because the drug was heavily marketed with a lack of independent evidence-based information.
-
The many ways in which physicians or their departments and staff are sponsored by industry.
People with diabetes have already witnessed the power of drug company advertising to the medical profession. In the 1980s the majority of people requiring insulin were transferred to genetically produced ‘human’ insulin even though there was, and still is, no evidence that ‘human’ insulin has any clinical advantages for patients over the natural animal insulin. Despite a catalogue of adverse reactions to ‘human’ insulin, it is now first line treatment for insulin requiring diabetes. People are not given the choice of insulin species and if information is requested, many people are told by their physician, diabetes nurse specialist and/or their pharmacy that animal insulins are no longer available. As Novo Nordisk only advertise their more profitable synthetic ‘human’ insulins to professionals, this misinformation may be understandable. However, it has affected prescribing habits resulting in a diminution of the sales of animal insulins so enabling the manufacturers to try to justify discontinuation of animal insulins in many EU countries.
In addition, global insulin production is in the hands of three multi-national companies providing them with a dominant market position. If they are allowed to provide information direct to consumers, the few remaining small insulin manufacturers will be unable to compete, resulting in ‘blockbuster human’ insulins that are not tolerated by a significant minority of people with diabetes.
NEWS RELEASE
Deaths associated with ‘human’ insulin omitted from review
Issued by
Insulin Dependent Diabetes Trust
JULY 22, 2000
Is it further suppression by the British Diabetic Association of information about ‘human’ insulin?
Two years after completion, a British Diabetic Association funded review of genetically engineered ‘human’ insulin and natural animal insulin has been published on their web site, but the original review has been changed to omit a section about deaths associated with ‘human’ insulin.
The review comparing ‘human’ and animal insulin was carried out and completed in July 1998 by the Cochrane Diabetes Group under Professor Rhys Williams, Nuffield Institute for Health, Leeds. It was presented in its entirety to the BDA Medical Conference in May 1999 including the section about deaths associated with ‘human’ insulin. This is now excluded from the review preventing this information being available to people with diabetes.
The following section from the original review has been omitted:
"The following observations can be made from this body of evidence:
1. Increased frequency of hypoglycaemia and reduced awareness of impending hypoglycaemia do occur when people are transferred from animal to "human" insulin.
2. In some cases (probably a small number) these phenomena may lead to death.
3. It is not possible to determine, from the evidence available, how commonly these phenomena occur.
4. From mortality data it is likely that any association with sudden death is uncommon.
It is not possible to say whether these phenomena are specific to "human" insulin or an effect resulting from tighter glycaemic control perhaps compounded, in some cases, by neurological complications in long standing-diabetes."
Page 5 of ‘Human and animal insulin compared’, 29 July 1998
Alteration of the original review raises serious ethical questions and omission of the information about deaths associated with ‘human’ insulin, continues to leave people with diabetes in the position of not being able to make a truly informed decision about their insulin treatment.
1. Why has the review been changed and who instigated the change?
2. Has the review been changed at the instigation of the BDA who funded it? If not what evidence has changed since the review was completed and put in the public domain in May 1999?
3. Why has it taken two years to publish the review and why now? During this two years animal insulins have been systematically withdrawn from many countries and Novo Nordisk have announced global withdrawal during this decade. Even though this review may be too narrow, earlier publication would have provided at least some evidence to assist patients in their attempts to obtain and maintain supplies.
The consumer based Insulin Dependent Diabetes Trust [IDDT], the only consumer group represented on the Cochrane Diabetes Group, believed that the review should be independently funded because of the controversy surrounding this issue for over 15 years. There was an unusual refusal to change the protocol, despite criticisms from those invited to comment on it, that the protocol was too narrow and did not include all the adverse reactions.
The BDA had already suppressed a report by Dr Natasha Posner carried out in the early 1990s showing that the adverse reactions were real and fell into a clearly defined group of symptoms. IDDT became suspicious and withdrew from all involvement with the review.
Statement from Jenny Hirst, Co Chairman of IDDT
" We welcome the more positive stance from the BDA that animal insulin must remain available, but we fear that this view may well be too late to influence the three major insulin manufacturers.
It seems our initial suspicions about the Review were not unfounded, and the removal of the section about deaths is very worrying. My faith and trust in all those involved in this whole ’human’/animal insulin debate has sunk to unbelievable depths. We know that the data sheets have issued warnings about hypoglycaemia and lack of awareness since the early 1990s. Patients also know that hypoglycaemia can cause death.
As both Aventis and Novo Nordisk [ref1] have publicly admitted the serious adverse effects to ‘human’ insulin, it seems that the reluctance to be honest about the problems with ‘human’ insulin may no longer rest with them. This is not a happy thought for people with diabetes.
As people in the US are now being faced with denial of the insulin they need, they are taking legal action. IDDT has always hoped that this would be avoided. We had hoped that there would be enough respect for patients’ experiences, a desire to establish the real extent of the problems with ‘human’ insulin and a desire to treat people with diabetes on the basis of evidence rather than mere unproven assumptions. But perhaps we were wrong. It is sad that it may be up to lawyers to enable people requiring insulin treatment to have full information on which to base their treatment options."
Co-incidentally on May 5th 2000, IDDT wrote to the Health Ministers, the Medicines Control Agency and the Committee on Safety of Medicines asking for guidance and information for doctors and patients as a result of new statements from insulin manufacturers, Aventis and Novo Nordisk. These referred to the adverse effects of ‘human’ insulin therapy, for the first time including worsening of retinopathy [ref 1]. No response other than acknowledgements from Lord Hunt and the Chairman of the CSM, has been received and therefore IDDT carried out its stated intention and widely circulated this information to doctors and healthcare professionals before informing people with diabetes through their Newsletter and web site on July 1st 2000.
Ref 1
April 24th 2000, Aventis:
"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."
September 1999, Novo Nordisk:
"Historically, improving glycaemic control with soluble human insulin
has been associated with an increased risk of hypoglycaemia."
For further information contact:
Jenny Hirst
IDDT PO Box 294
Northampton
NN1 4XS
Tel 01604
622837 e-mail
jenny@iddtinternational.org