OCTOBER 2002 NEWSLETTER
On
·
The reviewers ‘could not identify substantial differences
in the safety and efficacy between ‘human’ and animal insulins [mainly pork]’.
·
‘Most studies were of poor methodological quality’.
·
Many patient-oriented outcomes like health-related quality
of life or diabetes complications and mortality were never investigated in high
quality randomised clinical trials.
·
No differences were found in metabolic control, with no
differences in HbA1cs between ‘human’ and animal insulins.
·
There was no
difference in the presence of insulin antibodies.
·
70% of the
trials were funded by insulin manufacturers.
·
Only 40% of
the trials provided at least some information on adverse effects. Apart from
hypoglycaemia, other adverse effects were hardly ever mentioned. The overall
picture does not show any substantial differences in hypoglycaemia events
between insulin species.
·
None of the
studies assessed costs or socio-economic effects.
·
‘Human insulin
was introduced into the market without scientific proof of advantage over
existing purified animal insulins, especially porcine insulin.’
This review means that although ‘human’ insulin has become the first
choice insulin for the majority of prescribing doctors, this prescribing habit
is not based on any evidence of benefit for the people they are treating. The
lack of evidence of any superiority of ‘human’ insulin over animal insulins,
and the fact that the research that was done has been shown to be
methodologically poor changes the whole perspective for patients, for doctors
and indeed for government health departments. The absence of investigations
into mortality, complications and quality of life is at best careless, at worst
negligent and certainly does not put patient welfare at the top of the agenda.
But this absence means that no one knows whether treatment with ‘human’ insulin
improves or more importantly, harms the lives of people with diabetes compared
to treatment with animal insulins with their proven safety records stretching
back over 70 years.
While IDDT and our members knew this already, this is not the time for
saying ‘I told you so’ but the time to recognise the importance of the
publication of this independent, ‘gold standard’ Cochrane Review. Doctors and
healthcare professionals can now provide their patients with insulin treatment
choices based on evidence, not assumption. Developing countries can now ensure
that affordable animal insulins remain available knowing that they are not providing ‘inferior’ insulins
for their citizens. Above all, this review empowers patients.
It provides us with information to make truly informed choices about
the species of insulin we wish to use. Our choices are simple - animal insulins
with a history of 70 years research and post marketing surveillance [being used
in real life for 70 years] or ‘human’ insulin with an absence of meaningful
research and an ongoing history of reported adverse reactions.
* For the
Consumer Summary of the Review, the abstract and the implications see page 8.
An outbreak of serious illnesses linked to the anaemia drug,
Eprex, shows that some patients do not react to genetically engineered proteins
as if they were natural.
This is a quote from an article in the New York Times, July 30, 2002, which also explains that human proteins like insulin and growth hormones are made through genetic engineering and given to people who do not make enough of their own. In the case of Eprex, a genetically produced anaemia drug from Johnson and Johnson, the patients react as if the protein was a foreign germ and the immune system tries to destroy it. The cause of the problems remains a mystery and the Johnson and Johnson factory in Puerto Rico is under criminal investigation.
The New York Times
says that although the Eprex case is the most serious, as some people become
dependent on blood transfusions to survive, virtually all genetically produced
drugs provoke immune responses in some patients, though usually small numbers.
But these reactions are becoming of greater concern as the numbers of
genetically produced drugs increase.
Dr Hubb Schellekens,
a professor at Utrecht University in the Netherlands, says of genetically
produced drugs, “Sometimes there are miracle drugs, but they can still have
severe side effects. That has come as a surprise to us, really.”
This is exactly what
was said about ‘human’ insulin when increased hypoglyceamia appeared in the
early trials – the problems were a surprise! If patients had been listened to
once ‘human’ insulin was on the market, the side effects from other genetically
produced drugs may not have come as a surprise 20 years later!
Experts now believe
that because genetically produced drugs are made by living cells, the outcome
is not as predictable as chemically made drugs and even slight changes can
affect the product, sometimes in unpredictable ways. So the tide may be turning
for these synthetic drugs and for genetically produced ‘human’ insulin. Let us
hope that this awareness filters through to experts involved in diabetes care.
The New York Times
quoted ‘human’ insulin made by genetic engineering as having a small percentage
of people that cannot tolerate the ‘human’ version and are trying to keep beef
and pork insulin available. What is a small percentage? If it is only 5% of
people using insulin, then in the UK alone 20,000 people suffer adverse effects
to genetically produced insulin – unnecessary effects because the natural
alternatives are available. Imagine what this figure is for people using
insulin throughout the world!
Are these large numbers the reason the experts, the health departments and the insulin manufacturers will not backtrack? Maybe they fear litigation, as has been threatened in other countries? If this is so, then they are failing to understand that the vast majority of people who need animal insulin simply want it to be available so that they have healthy and good quality lives. They want choice. If litigation was to succeed, financial compensation cannot bring back the years lost to ‘human’ insulin and financial compensation is valueless if life is plagued by adverse reactions.
Research has shown
that depression may occur in up to 14-18% of people with diabetes with some
research showing that people with chronic conditions, including diabetes, are
three times more likely to suffer depression than the general population.
A study by Brazilian
researchers, presented at the American Diabetes Association Conference 1998,
showed that among a group of people with diabetes with average HbA1c levels of
less than 9%, only 21% tested positive for depression using a standardised
test. By comparison of those with HbA1cs over 9%, 42% tested positive for
depression.
The researchers used cognitive therapy to reverse the depression. In
those people where depression improved, there was an average HbA1c of 8.3%
while those who showed little improvement had an average of 11.3%. While these
results show an association between high blood sugars and depression, it
remains unclear whether high blood sugars cause the depression or depression
causes high blood sugars.
The signs of
depression include the following:
·
No longer
enjoying or being interested in most activities.
·
Feeling tired
or lacking energy.
·
Being agitated
or lethargic.
·
Feeling sad or
low much of the time.
·
Weight gain or
weight loss.
·
Sleeping too
little or too much.
·
Difficulty
paying attention or making decisions.
·
Thinking about
death or suicide.
If you have some or all of these symptoms over two weeks or more, then you should see your doctor.
Research [Ref 1]
using questionnaires has shown that depression in people with both Type 1 and
Type 2 diabetes may have the following effects:
·
They are less
likely to eat the types and amounts of food recommended.
·
Less likely to
take all their medications.
·
Less likely to
function well, both physically and mentally.
·
Greater
absenteeism from work.
Ref
1 Archives of Internal Medicine, Nov 27, 2000
DAILY
MAIL, August 29, 2002
‘The
GM Injection’ by Jo-Ann Goodwin
Many of you will have
read this article but for those that haven’t we are enclosing a copy with this
Newsletter. It is a well-balanced article that emphasises that while the
majority of people appear to be fine using GM produced insulin, some people
have experienced very real adverse reactions that have had a tremendous effect
on their lives. IDDT has been inundated with phone calls and e-mails from
people with diabetes or their partners, none of whom have criticised the
article although there has been expressed anger at the misinformation or lack
of information they have been given.
Perhaps the overriding feelings are of relief:
·
Relief that
they are not alone with the adverse effects they are experiencing. Relief that
these are not ‘all in their mind’ as said by their diabetes team when they are
not believed. Relief that there are alternative insulins for them to try –
natural animal insulins. Relief that the Cochrane Review has shown that
synthetic insulins are not superior to animal insulin. Relief that now there is
no reason why they should not change to pork or beef insulin and there may be a
way out of the problems they are having. ‘Light at the end of the tunnel’.
·
Relief from
people that are already using animal insulins – they have discovered that IDDT
is actively campaigning to try to maintain availability of the insulins they
need to maintain their health and wellbeing.
A great deal of anger expressed!
·
Anger that
they were never told that the ‘human’ insulin they are taking is produced by GM
technology. Anger that the very name ‘human’ implies that it is derived from
human beings.
·
Anger that
they have never been given the choice, especially now they know that GM insulin
has no advantages over natural animal insulins. Anger that they or their loved
ones have suffered all the adverse effects in the article but no one has ever
suggested trying animal insulin to see if their adverse effects disappear.
·
Anger that so
little research has been carried out to compare GM and natural animal insulins,
especially when people have complained of adverse effects from the outset.
·
Anger at the
apparent lack of honesty and at the marketing techniques used when their health
and wellbeing is at stake.
The gratitude!
To Jo-Ann and the
Daily Mail for publication and for the in depth investigation. To IDDT for
being there and not giving up, despite all the odds and for providing
information and support – ‘just to talk to someone that believes me is
wonderful’. And many people want to turn this gratitude into action to ensure
that animal insulins continue to be available; that people with diabetes are no
longer mislead and that they receive the informed choice of insulin they
deserve. With this support, IDDT’s cause will go from strength to strength!
From January 1st 2002
the federal health insurance programme covers an annual glaucoma test for the
following groups of Medicare recipients:
·
People with
diabetes
·
People with a
family history of glaucoma
·
High risk
groups such as African Americans aged 50 and over because they are five times
more likely to develop glaucoma than Americans of European decent
Glaucoma affects 3
million Americans and early detection and treatment helps to prevent blindness.
Also from January 1st
2002 Medicare covers medical nutrition therapy for people with diabetes as well
as those with kidney disease. This decision was based on a study carried out by
the Institute of Medicine showing that nutritional therapy with a registered
dietitian was cost effective for the elderly and improved their quality of
life.
Approval for Hypurin Bovine Neutral cartridges
Health Canada, the
drug regulatory body in Canada, has approved Hypurin Bovine Neutral insulin
cartridges for importation from CP Pharmaceuticals in the UK with the
appropriate documentation. Other Hypurin Bovine insulins may also be imported
in vials only. The significance of Health Canada approving importation from the
UK is that this means that the costs may be covered by the insurance companies.
Carol Baker, IDDT-
Canada, has clarified the situation with Health Canada. Contrary to rumour,
Hypurin pork cartridges have not been approved by Health Canada for importation
and nor has beef insulin from Brazil. Anyone importing from Brazil risk having
their insulin confiscated at customs.
Since the July
edition of the IDDT Newsletter there seems to have been a cluster of official
warnings issued to doctors about drugs and medical devices that could affect
people with diabetes. In the US and Canada these notices are made public so
that ‘patients’ as well as doctors have the information but in the UK such
warnings about drugs are issued to a whole range of professionals but not to
the very people that use the drugs! These warnings are important so surely
everyone should be aware of them, whether patients or doctors, so that we as
patients, are not reliant on the information being received and read by
professionals and then transmitted to us.
30 May 2002
Zyban is a drug
licensed to help people to stop smoking. Since it was first on the market it is
estimated that 419,000 people have used Zyban. But the Committee on Safety of
Medicines [CSM] have received over 5,000 Yellow card reports of adverse
reactions. 126 of these reports were of people having seizures.
Therefore the CSM
have issued warnings to doctors:
·
changes in the
recommended dose
·
the use of
Zyban is contraindicated in people with certain conditions where there is
already a risk of seizures.
·
there are
certain conditions where Zyban must NOT be prescribed and these include people
treated with oral hypoglycaemic drugs and those treated with insulin. Clearly
this means that people with Type 1 and Type 2 diabetes should NOT be prescribed
Zyban. The exception to this is where there is compelling clinical
justification that the potential benefit of stopping smoking outweighs the
increased risk of seizure for prescribing Zyban.
The MDA and Eli Lilly
have received reports of the breakage of both engagement tabs on the blue
insulin cartridge holders for the HumaPen Ergo injection pen. Some of
these breakages have meant that people
have given themselves insufficient insulin resulting in loss of blood glucose
control. The breakage can usually be identified by the user when the pen is
primed prior to injection.
Lilly has made design changes to the cartridge holder as a result of these reports. The original blue cartridge holder has been replaced with a clear one since when there have been no reported breakages.
This Device Alert has been issued to remind healthcare professionals of the insulin cartridge holder replacement programme being run by Eli Lilly because there is still a significant number of users that have not yet had there cartridge holder replaced.
Action
· If the cartridge holder is clear, then no further action is needed. Pens with blue cartridge holders were not distributed after October 2000.
· If the cartridge holder is blue, it should be replaced and a new clear holder fitted.
· New clear cartridge holders can be obtained from Lilly on freephone 0800-085-3847 or from community pharmacists, diabetes clinics and dispensing GPs
Avandos
[rosiglitazone] and Actos [pioglitazone] are both drugs for the treatment of
Type 2 diabetes. In the UK they should only to be used in combination with one
of the other oral drugs for Type 2 diabetes, metformin or a sulphonylurea and only when adequate blood glucose control
cannot be achieved with these drugs although in the US Avandia and Actos can
used either on their own or in combination with the other two drugs. Neither
Actos nor Avandia are approved for use with insulin.
They belong to a
class of drugs known as the thiazolidinediones or glitazones and the first drug
of this type, troglitazone [Rezulin] was withdrawn from the market following at
least 92 known deaths in the US from liver failure and/or congestive heart
failure. Avandos and Actos are successors to troglitazone and from the outset
prescribing doctors have been advised that patients using either of these drugs
should have liver function tests before starting the drug and at regular
intervals thereafter. It has also been known that they may cause fluid
retention [oedema] that can lead to congestive heart failure, especially in
people with an existing heart condition.
On April 26th
2002 the FDA issued a new warning notice that thiazolidinediones or glitazones,
which include Avandia and Actos, may cause fluid retention that can progress to
heart failure. They should not be used in people who have or have had heart
failure, fluid retention or active liver disease.
Patients who develop oedema,
shortness of breath, weakness, fatigue or sudden weight gain should advise
their doctor immediately.
They also warn that it is important to note that people with Type 2 diabetes are at an increased risk of diabetes related complications such as heart failure whether they take any specific type of diabetes treatment or not. Following discussions with the FDA, the manufacturers of Avandia and Actos have issued letters to health professionals reminding them of these safety concerns.
As early as October
2000, Takeda Chemical Industries, Japan's largest drugmaker, warned doctors of
potential dangerous side-effects of Actos and in November 2001 Health Canada
issued warnings to Canadians of their safety concerns related to the use of
Avandia and Actos after 4 deaths were associated with Avandia. Health Canada
warned that these drugs are not to be used in patients with acute heart failure
or active liver disease and patients who develop oedema, shortness of breath,
weakness, fatigue or sudden weight gain should advise their doctor immediately.
Therapeutics Initiative in Canada [a body that functions rather like the UK’s
NICE] states “Long-term trials are required
to know whether this class of drugs reduces morbidity and mortality outcomes”.
Worth noting!
Special Note -
Avandia and Actos are NOT approved for use with insulin.
IDDT has received several calls from people that are using insulin and
have been prescribed Avandia or Actos. In view of the fact that neither of
these drugs is approved for use with insulin, we would recommend that you
discuss this with your doctor.
COELIAC DISEASE – A TICKING OFF!
In the Spring 2002
Newsletter I included a short article about coeliac disease and diabetes and I
got a nice but sharp rebuke from one of our members for not providing the
obvious information about coeliac disease and its symptoms. For this I
apologise! I thought of it as a follow up article to ones published previously
but I now realise that this was quite some time ago – time passes so quickly!
So here goes.
·
It is a
condition in which the lining of the small intestine is damaged by gluten.
Gluten is a protein found in rye, wheat, barley and possibly oats.
·
This damage
causes foods to not be absorbed properly by the small intestine and so before
diagnosis there is weight loss and possibly malnutrition.
·
Treatment is a
gluten free diet.
·
It is
relatively uncommon with an incidence of 1 in 1000 people in the UK and it may
occur at any age.
Coeliac disease can cause people to be acutely and severely ill with weight loss, vomiting and diarrhoea or there may be chronic symptoms, such as tiredness, lethargy and breathlessness but usually the symptoms are somewhere between the two. However, some people are diagnosed without having any symptoms.
Adults may have a
history of abdominal discomfort or they may develop coeliac disease at any
time. Anaemia, mouth ulcers and weight loss are common signs.
Babies are fit and well until the introduction of solid foods that contain gluten when the baby becomes pale, bulky, offensive-smelling stools and is lethargic and miserable.
All these symptoms
could apply to other conditions so it is important that you do not assume that
you have coeliac disease but seek medical help. It is nearly always diagnosed
by a gastroenterologist who carries out an intestinal biopsy.
Both diabetes and coeliac disease are autoimmune diseases and there are increasing amounts of research to show that there is a link between the two in adults, children and adolescents. Increasingly there are views that more attention should be given to this link and that tests for coeliac disease should be routinely carried out.
A strict gluten free diet is the only treatment that puts the intestine back to normal.
Diabetes requires a
well balanced diet with plenty of carbohydrate but once coeliac disease has
been diagnosed, providing carbohydrate becomes more difficult as many of the
carbohydrates we eat and enjoy, such as bread, pasta, cereal, pastry, crackers,
biscuits and cakes contain gluten which has to be avoided. This is particularly
difficult for children. These foods can be replaced with gluten-free products,
some of which are available on the NHS in the UK. But as there is no gluten in
the flour, the products do not have the same consistency and taste and are
often not so delicious.
Some products are available with a gluten-free symbol but there are some difficulties:
·
There is a
lack of choice.
·
Pre-prepared
foods are much more difficult to obtain because many of them contain gluten eg
the flour used to thicken sources contains gluten.
·
It takes time
to become familiar with the ‘hidden’ gluten eg wheat flour is often used as a
carrier for flavouring in such things as crisps.
·
Buying
gluten-free products is very expensive.
NOTE: IDDT has now produced a leaflet ‘Diabetes and Coeliac
Disease’. If you would like a copy contact IDDT, PO Box 294, Northampton NN1
4XS
Tel 01604 622837
e-mail bev@iddtinternational.org
The mhi-500 needle-free injection system – is an alternative to pens or syringes for injections. It works by forcing a fine stream of insulin at high speed through a precision engineered nozzle. It costs £120 and is not available on the NHS although the manufacturers, The Medical House, are seeking approval. For more information there is a freephone helpline: 0800 917 7328 or visit www.insulinjet.com
Insulin aspart [NovoRapid] -
the fast acting insulin analogue is now licensed for use in the insulin pump by
subcutaneous insulin infusion through the stomach wall. Absorption from this
site is faster than other injection sites.
Latest government figures for pharmaceutical company profits
- all pharmaceutical companies
operate to strict limits on their profits from NHS sales based on a maximum 21%
return on capital employed. The last government figures show an actual profit
of 17%.
CP praised
– After visiting CP Pharmaceuticals, Doug Touhig, from the Ministerial
Sub-Committee on Biotechnology praised the company for supplying animal insulin
to the Czech Republic. CP’s Chief Executive, Charles Savage, said the company
was able to respond at fairly short notice to a request from the Czech Republic
for animal insulins following Eli Lilly’s announcement that they was replacing
animal insulins with synthetic ‘human’ insulins. Mr Savage said that if the
demand for animal insulins grows, it is still possible for additional
manufacturing lines to be installed.
The Wall Street Journal, 19.6.02 - Medtronic Inc announced that early research in 5 people
in France suggests that a surgically implanted device like an ‘artificial
pancreas’ could be on the market in the next few years. The device would
monitor blood glucose and pump insulin into the bloodstream and would have the
advantage of preventing hypoglycaemia and long-term complications.
DRIVING ACCIDENT – THE VICTIM’S WIFE WRITES TO IDDT
In July 2002 many of the Newspapers reported that Jo
Taylor’s husband was killed in a motor accident by a driver with diabetes who
was hypo. Jo has written to IDDT and asked us to publish her letter.
My husband Phillip was killed by a diabetic driver last
July, aged 33 years, the father of my two year old daughter. At Reading Crown
Court on 3rd July 2002, Richard Turpin was found not guilty by a jury who
accepted his defence of automatism. How
does your organisation respond to the evidence of a man who got into his car
everyday without testing, taking food or injecting himself before commencing
his journey to/from work. He stated that
at the time that he was having problems recognising the signs of hypo's coming
on, and his doctor changed his medication.
He stated in Court that he took no extra precautions with his new
regime. A doctor gave evidence in his
defence, having last treated him as a patient 4 years previously, stating that
he had never told his insulin dependent patients to self-test prior to driving.
My reason for writing
is that I am trying to get some awareness through the diabetic community that
it is imperative that a diabetic self test prior to commencing his/her
journey. We are being made more aware by
the media that this isn’t a one off. I
would really like to see diabetics taking more responsibility for their
condition, and to try and avoid another tragedy like this.
We DO NOT want to tar
all diabetics with same brush, but if we can save someone else’s life through
getting this message over, it will all be worth it! I would welcome your views
on this matter.
I look forward to
hearing from you.
Mrs Jo Taylor
One can only imagine Jo’s feelings in this awful situation
and I found my reply difficult to write but here are the main points. Jo
replied with a very nice letter of thanks saying that she was unaware of all
these points.
Dear Jo,
Firstly on
behalf of our Trustees, and I am sure every member of our organisation, I would
like to express our condolences to you and your daughter for the very sad loss
of your husband, Phillip. We all agree with you that their needs to be greater
awareness of the dangers of hypoglycaemia and especially in relation to
driving.
We are
constantly raising this issue because we are very aware that the insulin
automatically prescribed nowadays, synthetic so-called 'human' insulin, in some
people is more likely to cause loss of warnings of hypoglycaemia compared to
the natural beef and pork insulins.
In addition,
doctors now recommend that blood sugars should be as near normal as possible
but the drawback of this 'tight' diabetic control is a threefold increased risk
of severe hypoglycaemia which in turn increases the risk of loss of warnings
from which a state of automatism can arise.
It is also
essential that people are given correct instructions about testing their blood
glucose levels before driving and this should be given on their regular clinic
visits. People are not allowed to drive if they have lost the warnings of
hypoglycaemia and the doctors signing the medical fitness to drive forms should
not sign them if patients have lost their warnings, assuming the doctor knows
this to be the case. The vast majority of people are very conscientious about
their diabetes and many people voluntarily surrender their licences.
Unfortunately
many people with diabetes are not given all this information, as demonstrated
by Mr Turpin’s doctor admitting that he did not advise people to test before
driving. We do our best to make this information public. Within the last 4
months I have written to every local paper in the UK describing the adverse
effects of 'human' insulin, the dangers of hypoglycaemia without warnings and
telling readers that animal insulin is available and many people that have
changed to it find that their warning symptoms return.
I hope from
this that you can see that we, as an organisation, have taken action to raise
this whole issue in every way we know how since we formed in 1994.
Could I
suggest that you also write to Alan Milburn as Secretary of State for Health,
it is the Dept of Health that need to be made very aware of the dangers of
hypoglycaemia and unawareness and the need for more resources for patient
education.
Sincerely
Jenny Hirst
INTERESTING
NOTE!
Doctors must inform
patients of side effects of drugs
In June 2002 the supreme court of Hawaii ruled that doctors that fail to inform their patients about possible side effects of the medicines they prescribe may be liable, in the event of an injury or damage linked to the drug. The decision came in the case of an 11 year old girl who was knocked down by a car when the driver fainted at the wheel. He had been prescribed a blood pressure pill called Prazosin whose known side effects include light-headedness and fainting.
OUT OF THE MOUTHS….
I remember many years
ago being a rather overbearing Mum and trying make sure that my daughter did a
blood test before bed. One day she shut me up by saying, “Yes I do a blood test
before bed but it only tells me what my blood glucose is at that moment and not
what really matters before bed – whether I am going up or coming down.”
A LOOK AT DIABETES CARE AROUND THE WORLD
As we know
diabetes occurs in countries around the world and treatment and care varies
according to availability of health services and staff. Dr Ahmed is a doctor at
the diabetic clinic at King Faisal Hospital in Saudi Arabia. He is responsible
for the care of 2,500 people mainly with Type 2 diabetes. Here is his
perspective of diabetes in Saudi Arabia and the effects on his patients.
The Black Zone in the life of diabetic patients
By Dr Almoutaz
Alkhier Ahmed
Diabetes is a
disease of figures, and each figure represents a meaning in the life of
diabetics. At the moment of the first diagnosis, usually doctors ask for some
investigations to confirm the diagnosis of diabetes. The blood glucose level
(which is a figure) is the corner stone in diagnosis.
What is more there are dates that are important milestone of
diabetes mellitus:
·
1920
is the date when Dr/Frederick Banting prepared pancreatic extract.
·
1922
the first time insulin was tested after efforts to purify it by teamwork
Banting and Best, J B Collip, Professor J J R
McLeod).
·
1979
is the date of the first scientific look to diabetes by the National Diabetes
Data Group (NDDG).
·
1980
the World Health Organization (WHO) Expert Committee on Diabetes and later the
WHO Study Group on Diabetes endorsed the substantive recommendation of the
NDDG.
·
1995
an international expert committee, working under the sponsorship of American
Diabetes Association [ADA] reviewed the scientific literature since 1979.
To the figures in the life of people with diabetes.
The WHO
criteria for diagnosis is venous fasting blood glucose level is above 140 mg/dl
[7.70mmols/l] and 2hour venous blood glucose above 200mg/dl [11mmols/l]. Then
the Expert Committee of the ADA published its recommendations, which include
new figures for diagnosis and a new category - venous fasting blood glucose
above 126mg / dl [7mmols/l] for diagnosis and the new category of Impaired
Fasting Glucose where the venous fasting blood glucose is between 110 mg/ dl
[6.1 mmols/l] and 126 mg/ dl [7mmols/l].
“ What is the optimum figure for the good control of
diabetes?”
This is a daily
question raised by the diabetics in our
clinics.
To answer this
question we should state something, that whatever we do, we cannot reach the
level of adjustment of the living normal human body, but our goal will be
reaching the near-normoglycaemiac level. From our experience a figure below
150mg/dl [8.3mmols/l] is accepted to avoid the hazards of chronic complications
such as large vessels diseases.
So what do we mean by “THE BLACK ZONE”.
This Zone
represents the figures where blood glucose levels are high but where patients
with Type 2 diabetes do not have symptoms although the process of complications
is going on.
Factors that allow patients to slip into the black zone:
1. Lack of
health services provided to the diabetics. In some areas there are no health
services or the ratio of health care providers to the population is inadequate.
2. Defects in
the health education program provided to people with diabetes.
3. Some
patients are swinging in the early phases of emotional reaction to the
diagnosis of diabetes (the denial, anger, depression and bargaining) and never
reach the phase of adaptation with diabetes. It is important that the doctor
guides his/her patient safely and smoothly through these phases up to the
adaptation. The phase of denial is sometimes very prominent especially if the
patient has a bad family history due to diabetes and in the phases of anger and
depression the patient could practice a self-damage behaviour such as alcohol
or drug intake which may aggravate the development of complications
How can the diabetics detect early complications?
Day by day
science added new techniques and investigations to the benefit of diabetics.
Among those are:
1. Early
detection of microalbuminuria to check for early stages of diabetic
nephropathy.
2. Checking
for early warnings of vascular changes.
3. Checking
for autonomic neuropathy in diabetics of more than 5 years duration of
diabetes.
4. Annual
checking of the eyes to detect early retinal changes
Are there any lights to avoid falling into this Zone?
It is a matter
of time for people with diabetes to reach adaptation to the diagnosis of
diabetes, but it is possible to avoid falling into this black zone by the early
detection of complications and by decreasing the risk factors for them and so
increasing the life span of people with diabetes.
I am very aware that
this Newsletter concentrates heavily on the issue of ‘human’ and animal
insulins so reducing space for the usual articles about other aspects of
diabetes. I make no apologies as this was the reason for IDDT formed. The
Cochrane Review provides very reliable information we have never had before -
the evidence that ‘human’ is not superior to animal insulin. So if people
choose to be treated with animal insulin, then there is no scientific evidence
on which this can or should be refused. The review means that animal insulins must not be
discontinued because the adverse reactions and long term treatment with ‘human’
and animal insulins have not been researched. This is no longer an issue that
matters to those people who know they cannot tolerate ‘human’ insulin but one
that the whole diabetes community needs to address, not to mention the
regulatory bodies and diabetes associations throughout the world.
Many thanks to all
the people that filled in our questionnaires, took the time and trouble to send
us their personal accounts of their experiences with ‘human’ insulin and have
offered to be involved in press coverage or in lobbying their MPs. We now have
a database of people prepared to take action and an up to date file of evidence
from ‘patients’. We are most grateful for your offers of help and will be in
touch with you in due course. We must act together and at what appears to be
the right time.
Jenny Hirst
‘Human’ insulin versus animal insulin in people with diabetes mellitus
by Richter B, Neises G
It was thought that
pig [porcine] insulin was more suited for use than cow [bovine] insulin, with
human insulin or synthetic products possibly better. However, the new insulins
were introduced before enough trials had been done to assess their effects.
There were concerns about the possible adverse effects of the new forms of
insulin.
A new Cochrane review
found 45 trials of insulin from different sources – mostly human and porcine
insulin. The reviewers found no proof of superiority of human over animal
insulin, in terms of diabetes control or adverse effects [including episodes of
hypoglycaemia].
The reviewers call
for utilisation studies of different insulin types especially in developing
countries, so that authorities can be in a better position to negotiate with
insulin manufacturers for their communities’ needs.
The abstract of the systematic review prepared and maintained
by the Cochrane Collaboration.
Background: Human insulin was introduced for the routine treatment of diabetes mellitus in the early 1980s without adequate comparison of efficacy to animal insulin preparations. First reports of altered hypoglycaemic awareness after transfer to human insulin made physicians and especially patients uncertain about potential adverse effects of human insulin.
Objectives:
To assess the effects of different insulin species by evaluating their efficacy
[in particular glycaemic control] and adverse effects [mainly hypoglycaemia].
Search
Strategy:
A highly sensitive search for randomised controlled trials combined with key
terms for identifying studies on human versus animal insulin was performed
using the Cochrane Library [Issue 2 2002], Medline [1966 to May 2002]. We also
searched reference lists and databases of ongoing trials. Date of last search:
May 2002
Selection
criteria:
We included randomised controlled trials with diabetic patients of all ages
that compared human to animal [for the most part purified pork] insulin. Trial
duration had to be at least one month in order to achieve reliable results on
the main outcome parameter glycated haemoglobin.
Data
collection and analysis: trial selection as well as evaluation of study quality was
performed by two independent reviewers. The quality of reporting of each trial
was assessed according to a modification of the quality criteria as specified
by Schulz and by Jadad.
Main results:
Altogether 2156 participants took part in 45 randomised controlled studies that
were discovered through extensive search efforts. Though many studies were of a
randomised, double-blind design, most studies were of poor methodological
quality. Purified porcine and semi-synthetic insulin were most often
investigated. No significant differences in metabolic control or hypoglycaemic
episodes between various insulin species could be elucidated. Insulin dose and
insulin antibodies did not show relevant dissimilarities.
Reviewers’ conclusions:
A comparison of the effects of human and animal insulin as well as of the
adverse reaction profile did not show clinically relevant differences. Many
patient-oriented outcomes like health-related quality of life or diabetes
complications and mortality were never investigated in high quality randomised
clinical trials. The story of the introduction of human insulin might be
repeated by contemporary launching campaigns to introduce pharmaceutical and
technological innovations that are not backed up by sufficient proof of their
advantages and safety.
Note: The importance of this review is such that it has been made ‘Feature Review’ on the Cochrane website and there is open access to the complete review by visiting:
http://www.update-software.com/cochrane/abstract.htm
What does the Cochrane review really mean to people with diabetes?
It means that there was not very much research carried out to
compare ‘human’ and animal insulins and
the research that was carried out, was mostly of poor quality. 70% of the
trials were funded by the insulin manufacturers, so for those of us that
already are just a little suspicious about industry funded research and the
risk of bias, we now see that most of this industry funded research was also of
poor quality! So with this in mind, we see that the review found no evidence of
differences in the adverse effects related to hypoglycaemia but only 40% of
trials mentioned them. The other reported adverse effects were not investigated
in any of the trials.
The review has dispelled many of the myths that are told to people with
diabetes.
·
It can no longer be said that ‘human’ insulin is better
than animal insulins, because there is no evidence for this.
·
It can no longer be said that ‘human’ insulin gives better
control and better HbA1cs, there is no evidence for this.
·
It can no longer be said that ‘human’ insulin produces less
antibodies, there is no evidence to support this.
·
The existence of other adverse effects, apart from
hypoglycaemia, was not even investigated, so their existence can no longer be
denied.
Important issues for people treated with insulin have never been
investigated
Perhaps the greatest importance of this review is that it highlights
the research that has NEVER been carried out. This absent research is essential
for us to know that we are being treated with the insulin that produces the
best effects on our health, our wellbeing and indeed our lives and even our
life expectancy. These are very basic requirements for any drug but perhaps
especially so for ‘human’ insulin - the first ever genetically produced drug to
be used on human beings. Twenty years after its arrival on the market with
indecent haste, ‘human’ insulin has never been subjected to essential, quality
post marketing research to answer the questions that must now be asked by
people who are prescribed it.
We need to
know:
Mortality – are the number of
deaths, the type of deaths and/or the age at which the deaths occur different
after treatment with ‘human’ or animal insulins?
Complications - do ‘human’ and
animal insulins affect the development of complications? Do they occur sooner
or more often with one type of insulin than another? Are different
complications affected differently? Does the rate of the progression of these
complications vary with the different insulin species?
Quality of
life –
is the quality of life better or worse with ‘human’ or animal insulins? Do
people feel better or worse according to which insulins are used? What
differences do people experience when using different insulins? Do they have
more or less mild hypos, more or less severe hypos, are the hypos or the
warnings different according to which insulin they use? Have they noticed any other
effects, such as weight gain, depression, aches and pains, inability to
concentrate etc?
If patients had been listened to, or better still, even involved in the
trial designs [wash my mouth out with soap and water!] then investigations into
all these questions and the reported adverse effects would have been included
in the trials.
What does the
Cochrane Review mean for doctors and healthcare professionals?
They now have the advantage of being able to provide information about
insulin treatment choices that is based on evidence, not the assumptions they
have had to use for the past 20 years. But they can no longer tell patients
that ‘human’ insulin is superior to animal insulin, that it results in better
diabetes control, that it is better because it produces less antibodies or any
of the many claims that have been made in favour of ‘human’ insulin.
The Review may well mean a total re-think on the part of many doctors
and diabetes specialist nurses. For some, this may be difficult to accept
because it goes against their beliefs from the information they have been
given. We can understand this and even sympathise with it but this Review now
gives them the chance to fully discuss insulin treatment with their patients on
the basis of evidence, something they, as well as we have been denied until
now.
Without doubt, doctors everywhere understand that their first and
foremost obligation is ‘first do no harm’. With no research to compare ‘human’
and animal insulin in relation to mortality, complications and quality of life
and with less than half of the trials investigating adverse effects,
unfortunately doctors prescribing ‘human’ insulin can no longer be certain that
they are ‘first doing no harm’ because they can’t know.
In the absence of research, doctors cannot be held legally negligent
for prescribing ‘human’ insulin, albeit with no superiority. But surely there
must be some moral responsibility on the part of medical experts and leaders in
the field of diabetes to ensure that appropriate comparative trials are carried
out to ensure that ‘human’ insulin does not cause more harm than its
predecessors. If this is not the case, and clearly it hasn’t been so with
‘human’ insulin, then how can be patients feel that their best interests are
being served? Surely patients can expect at least this level of assurance
before the majority of the diabetic population is changed to ‘human’ insulin
which can be for no other reason than the marketing wishes of the insulin
manufacturers?
After 15 to 20 years of prescribing ‘human’ insulin on the basis of its
believed superiority, doctors are now in an unenviable position. Their
prescribing of ‘human’ insulin and the changeover of people from animal to
‘human’ insulin is not and never has been, based on any evidence of benefit.
But perhaps worst of all, the complete omission of research into mortality,
complications and quality of life means that they no longer know that they have
followed their own code of ‘first do no harm’, especially when there is so much
evidence from patients to the contrary.
Global
implications
With the major insulin producers having already removed animal insulins
from the market in many developed countries, this Review may not halt or revoke
this process. Market forces and shareholder profits are clearly more important
to them than patients’ needs otherwise discontinuation of animal insulins would
not be taking place, especially not without the essential research being
carried out first. If doctors decide that they do not wish to prescribe ‘human’
insulin because of the lack of research to support them then market forces
could change the situation. If the medical profession give patients ALL the
information they need to make an informed choice of insulin species, then many
people may well choose tried and tested natural animal insulin in preference to
the under-researched and poorly researched ‘human’ insulin. But if doctors fail
to give a fully informed choice including risks and benefits, then they are
failing in their duties and carry the full responsibilities for this as pointed
out by the Medical Defence Union in Pulse, May 20, 2000.
Cost
Implications
The Review will enable a worldwide assessment of insulin species and
their availability. Its biggest benefit may well be for people in developing
countries who are dying as a result of the replacement of affordable animal
insulins with significantly more expensive ‘human’ insulin. Healthcare
decision-makers have now been provided with evidence to show that they can use
less expensive animal insulins and they have the power to negotiate prices more
effectively with insulin manufacturers.
But developing countries are not the only countries to be affected.
Developed countries where animal insulin is still cheaper than ‘human’ are
affected and the NHS is no exception – something IDDT raised several years ago
but no one was interested in pursuing the extra costs to the NHS that are
incurred by prescribing ‘human rather than pork insulin.
For example a 10ml vial of Novo Nordisk Human Actrapid costs about
£4.00 more than a 10ml vial of their Pork Actrapid. If the average person uses
3 vials per month then the extra cost to the NHS of using ‘human’ insulin, with
its lack of superiority, is £150.00 per year. This might not sound much but if
this is applied to only one quarter of people using insulin, assuming that as
many as three quarters not using vials but pens, then this extra and
unnecessary cost to the NHS is £15million per year! If half are using vials and
not pens, then the waste is £30million per year!
These millions would go a long way towards funding the rising costs of
diabetes care and the National Service Framework for Diabetes that we read so
much about. Raising NHS standards of care has to be paid for and cutting these
unnecessary expenses seems like a logical way of helping to do just that. But
in an NHS era when the cheapest drugs are supposed to be prescribed first, it
is hard to understand why insulin has been made the exception to this. Is it
the power and influence of the pharmaceutical industry, either directly or
indirectly, or is it simply mismanagement?
Our thanks
must go to the reviewers, Drs Richter and Neises, for their determined work in
carrying out this very valuable review. We must also thank Sir Iain Chalmers of
the UK Cochrane Centre for his unfailing support in trying to ensure that the
diabetic community has the best possible evidence to inform their healthcare
decisions.
It
is an international non-profit organisation that aims to help people make
informed decisions about health care by reviewing and promoting the best
available evidence from research on the effects of various treatments. The
Collaboration also aims to influence what the direction of future research by
identifying areas where more research is needed.
We
are all aware that some health care treatments make you better, some don’t and
sometimes the treatment can be even worse than the condition. Sometimes it
seems as though a drug/treatment worked, but really the benefit came from
something else or maybe you would have just got better anyway. So both patients
and doctors need good evidence from research to know the effects of a drug or
treatment in order to decide whether we should try it. This also applies to
decision-making bodies, such as the NHS.
However
good individual studies maybe, they are often carried out on specific groups of
people or on small numbers so the results cannot be extended to assume that the
effects of the treatment will be the same for everyone with a particular
condition. Publication bias also creeps in as a great deal of good research is
not published and so we are not receiving the complete picture.
Cochrane
groups carry out systematic searches for all the studies on a topic and then
sort out which are the good quality studies [randomised controlled trials or
RCTs]. Conclusions can then be drawn that give a much more complete picture of
whether or not a drug/treatment is effective. A review may show that there is
no evidence to support a particular drug/treatment or that little or no good
quality research has been carried out. This is equally important because it
means that the use or prescribing of that drug/treatment is not based on proven
benefit from research.
Insulin glargine,
called Lantus, made by Aventis was launched on to the UK market in September
and is a long acting basal insulin analogue,. Lantus is a synthetic insulin and
is being proclaimed as the first truly long acting insulin. It seems to have
been conveniently forgotten that long acting beef insulin has always been
available and still is!
Lantus is intended to
be injected as a single injection at bedtime and has a smoother action over 24
hours than previous synthetic long acting insulins. It is possible that this
may be tolerated better than ‘human’ intermediate acting insulins but only time
and research should tell us this. Much of the existing research has been in
people with Type 2 diabetes and it has shown that there is a reduced risk of
hypoglycaemia when using Lantus compared to the usual ‘human’
intermediate-acting insulin [isophane/NPH].
Lantus research so far…..
Research has only compared Lantus to ‘human’ insulin. At an Aventis sponsored symposium at the annual professional conference of Diabetes UK, Professor David Owens who carried out some of the research said that compared to existing long acting insulin [‘human’]]:
· Lantus has greater molecular stability than previous ‘human’ insulins resulting in a flat action profile compared with an early peak in present longer acting insulin. Thus there is less risk of hypoglycaemia.
· It is well tolerated and at least as effective as present longer acting ‘human’ insulin.
·
It has NOT
been shown to improve HbA1cs but is at least as effective at helping to
maintain target HbA1c levels but with less risk of hypoglycaemia. [It is not
clear from the report whether this reduced risk of hypos is theoretical or has
actually been proved in trials.]
·
No research
has been carried out into its use in pregnant women.
Forewarned is forearmed – it’s clear!
The UK can learn from
the US experience! Unlike all other long acting insulins Lantus is clear not
milky. At the Aventis symposium, diabetes specialist nurse, Jill Hill said this
was an advantage because it would not have to be shaken before injections and
that this was ‘just one less thing that
patients will have to remember to do.’ But practical experience of using
this new clear long acting insulin in daily life in the US, is a little
different!
A letter in Diabetes
Care, Feb 2002, warns that two patients described as having ‘excellent
compliance’, mistakenly injected their very rapid short acting Humalog instead
of their Lantus [glargine]. Both
injected their normal larger bedtime dose but of Humalog instead of Lantus. As
both insulins are clear, this is an easy mistake to make, especially when tired
before going to bed. Fortunately both these people realised what they had done
before going to bed took remedial action. However, the letter recommends that a
coloured dye is added to Lantus to prevent similar mistakes that could have
disastrous consequences as a result of a large dose of fast acting insulin
being injected before bed. We would all rather shake the bottle than run this
risk!
Aventis obviously were aware of the risk of confusion with clear short acting insulins, because Lantus is marketed in a different shaped vial from all other insulin vials – it is longer and thinner and the label is in purple writing. Responses from other physicians showed that these two cases were not isolated and as Lantus is only available in vials for injection with syringes, these physicians prescribed pens for the short acting insulin to avoid the risk of confusion. However, they expressed concern that if Lantus becomes available in cartridges for pens, then the risk of confusion would arise again.
Just £2.00 a month – can you help?
Thanks to you and to
the specialist nurses in diabetes clinics up and down the country, IDDT has
been able to send almost weekly supplies of insulin and other supplies to help
adults and children in developing countries. Over recent months our supplies
have been going directly to the Dream Trust in India.
Dream Trust is a
registered charity and non-government organisation [NGO] which helps towards
making the life of underprivileged children with diabetes, especially girls,
more bearable and more meaningful. Poor families find it difficult to commit a
quarter of their monthly income for the treatment of a diabetic child.
Dream Trust formed in
1995 after the shocking deaths of two little girls whose mothers had stopped
giving insulin because they simply could not afford it. The sponsored children
are given free insulin, syringes, monitoring strips and Dr Pendsey monitors
their healthcare.
But these are not the
only problems. Debilitating, social, cultural and economic factors in India
continue to discriminate against girls in appalling ways. In the Indian
context, marriage of girls with diabetes is a serious problem. Parents find it
difficult to arrange marriages of their daughters with diabetes and even hide
it, but these marriages invariably end in separation. The Trust helps to
arrange marriages and also focuses on vocational training to help the girls to
become financially self-reliant.
Can you help?
It costs as little as
£2.00 a month to sponsor a child and save lives at Dream Trust. Sponsoring
these children will help to ensure that they are cheerful, healthy and can be
looked at as important family members with a future.
We all live with
diabetes under very different circumstances and we get cross if things like
pre-filled pens aren’t available free on the NHS – the Rolls Royce way of
injecting for the majority of people by comparison to the children of Dream
Trust! In our world, it is impossible to imagine having to allow your child to
die for lack affordable insulin.
Just as little as
£2.00 a month from you will help to avoid these tragic deaths.
Just £2.00 a month from you will prevent these children from being small, sick and unhappy.
Please help us to
help the children at Dream Trust. It’s easy – just fill in the sponsorship form
to make a regular monthly donation from your bank. If you require further information,
contact: Bev Freeman, IDDT, PO Box 294,
Northampton NN1 4XS Tel 01604
622837 Fax 01604 622838
e-mail bev@iddtinternational.org
Dear Jenny,
I studied your website
for the first time and was impressed with the amount and clarity of your
information regarding Type 1 diabetes and all the adverse effects of human
insulin. I am a Certified Nurse Midwife in the US and used your site in an
assignment for homework in my MSN degree.
Thanks for the
opportunity to browse and learn from IDDT
Ms
JWC, United States
Dear Jenny,
Having read your
excellent article on the first three pages of the Summer 2002 Newsletter, I am
horrified at the thought of not being able to obtain animal insulins that I
need. I have been on these insulins for 52 years and have kept remarkably well
and active.
I refused to change
to synthetic insulin when it was ushered in as my consultant could not give me
a reason why the change would be advantageous. My only experience of it was
when I entered hospital about 8 years ago for a minor operation. They put me on
a drip of human insulin and dextrose because they said there were no drips
containing animal insulin. I later found out that they could have made one up
for me! When I came round from the anaesthetic I felt very ill and not at all
like a ‘normal’ hypo, but my blood sugar was 2mmols/l and dropping fast.
Your article mentioned that Biobras was the major supplier of animal insulin crystal. Does this mean that there are smaller ones?
The ‘Truth in
Medicine Campaign’ must go on. Thanks to you all at IDDT for your diligent and
excellent work.
Mrs
TP, SW
Jenny comment:
there are other suppliers of animal insulin crystals so we are not entirely
reliant on Biobras, now part of Novo Nordisk, for the supply. We also have to
remember that CP Pharmaceuticals make beef and pork insulins in vials and
cartridges for pens, so we are not entirely reliant on Novo Nordisk pork
insulin. However, for many people, this will mean changing brands and we know
that even different brands of the same type of insulin can affect diabetic
control so adjustments to dose and timing may be necessary as well as careful
monitoring when changing to CP’s Hypurin range of animal insulins.
Blood pressure pills and hypos
Dear Jenny,
I have been taking
Enalapril for high blood pressure and having reached the maximum dose my GP
thought he would try a different drug. I was put on Cardura [doxazosin] which
brought down my blood pressure really well but in doing so triggered completely
unpredictable and very aggressive hypos with blood glucose levels as low as 1.7
whilst I was still unconscious. After 3 months I was prescribed Hytrin
[terazosin hydrchloride] and again had very aggressive hypos. I started to run
my blood sugars higher in self defence but started to feel unwell and returned
to my GP who decided that the risks were unacceptable and I was returned to my
original drug.
Mr
S.B.
Derbys
Jenny’s comment – the message here is to be aware that all drugs can have adverse effects and these may affect blood glucose levels. Mr S.B. took the correct action and discussed alternatives with his GP.
The Dept of Health has reported on a pilot scheme in Essex where NHS Direct nurses refer callers to a community pharmacist for additional help when they would previously have been referred to a GP. The report showed that:
·
Over 90% of
people took less that ten minutes to get to their pharmacy and almost 70% went
to a pharmacy within 4 hours.
· 80% of callers thought that it was appropriate to be referred to a community pharmacy and were satisfied with the advice that was offered.
The Dept of Health will roll out the community pharmacy scheme nationally later throughout this year.
ePolitix and IDDT
For internet users
ePolitix is a website that provides information about what’s happening in
Parliament, the news and the media. It is widely used by politicians, civil
servants, political researchers and journalists to find information about a
whole variety of issues that are of concern to them or on which they may have
to make a statement. The Trustees decided that IDDT should have a ‘mini’
website on ePolitix website as it used by the very people that can influence
our cause, politicians, civil servants and journalists and this went live in
July. You can visit IDDT’s MicroSite at www.epolitix.com/forum/iddt or www.epolitix.com/forum/insulin-dependent-diabetes-trust
We are aware that many people do not have or even want access to the internet! But this is just one way that we can increase our presence and influence to get the issues that matter to us, to a wider audience.
IDDT and JustGiving
We are delighted to report that there is an increasing number of people joining IDDT through our website www.iddtinternational.org but we are very aware that there is understandable concern about making donations or payments of any kind over the internet. We have therefore become part of JustGiving which offers a secure way of making credit card donations via the website – you just CLICK on the JustGiving button on the Homepage of each country’s website.
Bruce Beale died on
July 26th this year, peacefully and pain-free. He will be sadly
missed by the many hundreds of people that have gained information, help and
support from him through his website. Many of our members have joined through
their contacts with Bruce and he has supported IDDT through thick and thin. On
a personal level, I shall miss him greatly as he has been of tremendous support
and encouragement. He was my sounding block when I was angry and my mentor when
I was in need.
Bruce had over 50
years experience of living with diabetes and was diagnosed as a child. He never
waivered from his belief in the rights of people to be involved in decisions
about their treatment and to have the treatment of their choice. He believed
that any insulin that increased the risk of hypoglycaemia and loss of warnings
was a risk not worth taking and that a carbohydrate restricted, and latterly
the low carbohydrate diet was the only sensible way to treat diabetes.
I cannot pay greater
tribute than to quote the words of Joan Hoover, who Bruce greatly admired for
her voluntary work in diabetes that made real improvements in the lives and
treatment of adults and children with diabetes.
“Bruce was a man of considerable spirit and intellect, and best of all, he was on the side of the angels, those who are trying to make things better.”
Our condolences go to
Bruce’s wife and family.
Jenny Hirst
As our readers know,
‘human’ insulin is not human insulin at all. It has always been amazing that
insulin manufacturers were ever allowed to call it ‘human’ because this has an
implication that it originates from the human body. Of course it doesn’t! But
it’s a fairly reasonable assumption by people that know little about diabetes
and perhaps even less about insulin, the newly diagnosed for instance, that
‘human’ insulin really is real insulin from human beings. When ‘human’ insulin
first appeared in 1982, people with longer standing diabetes could be excused
for assuming that it was in some way extracted from human beings. They were
used to using beef or pork insulin extracted from cattle and pigs, so it wasn’t
that unreasonable to assume that ‘human’ insulin was actually from human
beings. It was a wonderful marketing technique to encourage people to change
from the natural insulin that suited them to one with no proven benefits!
So where does ‘human insulin’ come from? Answer – different manufacturers make it from different
ingredients, from e-coli or yeast. Genetic modification turns into something
that is identical to the insulin molecule the body should produce. So it’s
certainly NOT real human insulin. A cheap PVC jacket may look like leather but
it isn’t and it cannot be sold as leather, indeed, the law doesn’t allow it.
But does this law apply to insulin? No, because believe it or not, drugs don’t come under the
same regulations! One of IDDT’s first actions was to make a formal complaint
that the name ‘human’ applied to insulin, was misleading to patients. The UK
Dept of Health denied this but said if we wanted to take the matter further we
would have to go to the World Health Organisation. This we did and the response
almost said that we were really rather silly and of course ‘human’ insulin was
not extracted from human beings and everyone knows that! Doctors and drug
regulators may know this, but patients don’t have their knowledge – a view that
IDDT passed to the World Health Organisation but to no avail.
So why discuss this now?
One of our new members raised this whole issue of the name ‘human insulin’
again. But she pointed out that by continuing to use the name ‘human’, even in
inverted commas as we always do, we are helping to perpetuate the myth that
‘human’ insulin’ is genuine insulin from the human body. Unintentionally, we have been helping to
mislead people with diabetes and equally unintentionally, we have helped the
drug companies to market their very cleverly named insulin. So as Editor of the
Newsletter, I have taken a unilateral decision! This is the last issue that
will use the name ‘human’ insulin. My
News Year’s resolution is already made and in the next issue due in January
2003 ‘human’ is out! Synthetic insulin, GM insulin, genetically produced insulin,
bacteriological insulin or any other names that spring to mind, are in!
NEWS FLASHES
The Welsh National Assembly is introducing national, free eye screening for everyone
with diabetes that is registered with a GP.
New government targets - new
performance targets have been published for health and social services. These
include a new maximum waiting times for hospital treatment of 3 months by 2008
and reduced waiting times in accident and emergency. New standards to help
elderly people live independently at home are also being introduced.
Merger of regulatory bodies - the Medicines Control Agency [MCA] that controls the licensing of
medicines and monitoring of adverse effects and the Medical Devices Agency
[MDA] that controls the use of medical devices eg insulin pens, are to merge
into one Agency in April 2003.
Herbal medicine safety - the
Medicines Control Agency has launched a new information service to provide up
to date safety information about herbal remedies. Herbal Safety News aims to
bring together information about past herbal remedies plus the latest news and
advice as it arises. Herbal Safety News is available at: www.mca.gov.uk/ourwork/licensingmeds/herbalsafety.htm
NSF for renal services - an
independent group of experts has been set up to advise the government on
standards for kidney services with a National Service Framework [NSF] for renal
services. It aims to raise standards, reduce variations in services and improve
health care of renal patients. The group
is expected to produce guidelines on prevention, dialysis and transplantation.
Since January 2000,
IDDT has used a press cuttings service to keep track of information in all
local and national newspapers about any matters relating to diabetes. In
particular we have tracked reports relating to hypoglycaemia. We have to be
aware that newspaper reports are entirely dependent on the editor’s decision to
publish, but the reports show there are reasons to be concerned about
hypoglycaemia and loss of warnings. Take a look:
|
Year |
Number of deaths |
Average age at death |
|
2000 |
4 |
35 years old |
|
2001 |
10 |
27 years old |
|
2002 to July only |
10 |
31 years old |
Notes:
1.
We removed all
deaths that were alcohol or drug related and deaths where coroner decided
suicide was the cause.
2.
The youngest
age at death was two and the oldest age was one person of 53.
3.
Two further
cases of sudden unexplained death were reported to IDDT during July – a 17 year
old girl and a 35 year old man.
4.
Unless a post
mortem is carried out within 4-6 hours of death, it is not possible to
ascertain whether the cause of death was hypoglycaemia. There were 17 additional reports where cause of
death was assumed to be hyperglycaemia but this could not be proven because
blood glucose levels rise sharply after death. All were found hours or days
after death and all reports have evidence that the deaths could have been due to
hypoglycaemia not hyperglycaemia.
|
Year |
Number rescued |
Average age |
|
|
2000 |
3 |
26 years old |
|
|
2001 |
9 |
34 years old |
|
|
2002 to July only |
11 |
30 years old |
|
|
Year |
Fatal accidents |
Average age |
|
2000 |
2 |
62 years old |
|
2001 |
5 |
45
years old |
|
2002 to July only |
6 |
31 years old |
Notes:
There was a total of
13 deaths. In all but 2 cases, the diabetic driver killed themselves, the other
2 deaths were victims of the accident.
Remembering that
these figures do not represent the whole picture by any means, there is
nevertheless, a pattern in both the people who died of dead in bed syndrome and
the people rescued from unconsciousness usually by relatives. Firstly, they
were all young people with Type 1 diabetes and so treated with insulin.
Secondly, the number of reports has increased from the year 2000 to 2002 and
the figure for 2002 could be expected to be even greater as we are only 7
months into 2002.
The first reports of
dead in bed syndrome appeared in the mid to late 1980s after the introduction
of tight control and ‘human’ insulin. Prior to this time doctors always
reassured their patients that ‘you can’t die in a hypo because your insulin
will run out and you will come round’. The cause of dead in bed syndrome is
still not known and there appears to be little or no research to investigate.
Hypoglycaemia is not caused by diabetes but by the treatment of it, so all these deaths were unnecessary deaths. The fact that they were also in young healthy people is even sadder and our sympathies must go to their families
NOVO NORDISK STOPS DRUG TRIALS
July 23rd 2002
Trials of Novo Nordisk’s new drug, NN622 also known as ragaglitazar, have been stopped after finding bladder tumours in one mouse and several rats treated with NN622. The trials in man were at an advanced stage, Phase III, with 1100 patients being treated with the drug in Europe, North and South America and Asia, only 42 of whom lived in Denmark. All the patients have now been taken off the drug!
Originally Novo Nordisk were developing this new drug with another company called Novartis but they pulled out last year without giving any reason.
This new drug is part of the glitazone family of drugs classed as sensitisers that enhance the absorption of insulin in Type 2 diabetes. [Troglitazone [Rezulin], Avandia and Actos are all the same family of drugs.] NN622 was expected to be another blockbuster drug to be on the market 2004 or 2005 with expected sales of over one billion dollars.
Novo Nordisk’s perspective
According to a
statement from Novo Nordisk on their website, the effects on rats were known
before the trials started in people but when a tumour appeared in another
species, the mouse, the trials were stopped. They also state that they informed
the participants of the tumours in rats and they all gave their consent. No
doubt true but one wonders just how informed was this consent, especially in
countries with differing understanding of ‘consent’? Was it a reassurance that
many drugs cause tumours in one species and it’s only when they occur in a
second species that it actually matters?
Most of us would
expect that the trials on rats AND mice would be completed BEFORE a new drug is
tested on people so that any possible development of tumours whether benign or
otherwise, would be discovered BEFORE there was any possible risk to the people
in the trials. But Novo Nordisk state that this is within international
research guidelines and that these guidelines do not demand that trials in rats
and mice are completed BEFORE Phase III trials in man take place. It is hard to
believe that international guidelines do not offer greater safeguards than this
but if they don’t, then participants in research, need to think very carefully
before taking part in any trials.
Consumer perspective
Remember this applies
to trials of all new pharmaceutical products. Your doctor may ask you to take
part in trials of a new insulin but insulin has to go through the same research
– rats, mice and then people. Some years ago one of Novo Nordisk’s first
attempts at producing an analogue insulin had to be stopped because it produced
tumours and this is why Lilly were first on the market with their analogue,
Humalog.
If pharmaceutical companies are to rely on us to be
participants in drug trials, then there has to be greater openness about
possible risks. For our part, we have to be sure that the consent is TRULY
INFORMED consent. This means not just relying on the information provided on
consent forms but asking questions, taking time to decide and not being afraid
to say NO, even if this is to our own doctor. In future, perhaps one of the
questions we should be asking is ‘Have
the trials on rats and mice be completed?’
IMPOTENCE TREATMENT – a perk for the Eurocrats!
Under the NHS people
that suffer from impotence and want treatment with Viagra are only allowed 4
Viagra pills a month. Regular readers will remember that when this regulation
was brought in, IDDT campaigned against it. We recognised that the theory
behind this was that impotence is more likely to occur in older men and
presumably the Dept of Health think that sex once a week is average for the
majority of older men! However, we pointed out to them that impotence can
affect fit, healthy young men with diabetes who do not want to have their
sexual activity restricted to once a week.
We were recently
contacted by just such a young man – 4 Viagra pills a week! His chemist has
quoted him £62.00 to purchase 8 more pills. Unfortunately this young man is
unemployed at the moment and his fortnightly income is £107.00 – can he afford
8 extra Viagra pills?
This situation is
grossly unfair and not made any more acceptable by a report in the Guardian
[9.8.02]. The EU institutions in-house medical insurer has now agreed to
reimburse MEPs 85% of the cost of 6 Viagra pills a month. So a UK MEP could get
4 on the NHS and 6 cut price ones through his EU insurance – 10 a month while a
young man with impotence caused by diabetes can only obtain four. Hardly fair!
SNIPPETS
A look to the future through the magic of science!
·
Scientists in
Nabraska have found a genetic mutation that causes high bone mass and healthy
strong bones. The mutation is caused by an amino acid within the gene and
researchers are now trying to develop a medication that duplicates the action
of the amino acid to treat or even prevent osteoporosis.
·
Some tooth
decay is caused by bacteria that live in the mouth and turn the sugar we eat
into lactic acid which causes the decay. A researcher in Florida has
genetically altered the bacteria so that it does not produce the lactic acid
that in turn, prevents tooth decay. He put the altered bacteria in a mouthwash
so that it crowded out the bacteria that cause decay.
·
Kidney
transplants have saved the lives of many people but there is always a shortage
of suitable donors. Plasmaphoresis is a new technique being developed which may
mean that mismatched kidneys can be transplanted by filtering out the harmful
antibodies that would otherwise cause the transplant to fail.
·
In the US,
videophones made by a Bristol Company, Motion Media, are to be supplied to
1,000 CareStations to help doctors and nurses treat patients with AIDS,
diabetes and TB. The CareStation sends and receives video images through
standard phone lines. An array of medical instruments, including stethoscopes
and blood pressure cuffs can be plugged into it. This means that doctors can
“visit” their patients by using videophones and, of course, save money and
time.
·
Dr Minor,
heads a department that has received £300,000 to replicate the controversial
Wakefield study linking MMR and autism. But at the same time Dr Minor is being
paid as an adviser to GlaxoSmithKline, one of the three MMR vaccine
manufacturers being sued by families who claim their children were damaged by
it. While we can all accept that his
advice may not be compromised by fees from the manufacturer, it does
little for public confidence in the system!
IDDT Christmas Cards
Our usual annual begging! Members have received a sample card, so please don’t forget to order your Christmas cards to help to support IDDT. If everyone just ordered one pack it would be great and even greater if you can help to sell some on our behalf! In case you have lost your order form, here’s another one!
Note: the cards can be viewed on our website www.iddtinternational.org/cards
|
Name
of Card |
No
of Packs |
Amount
payable |
Christmas Firs at
£2.75 for 10
|
|
|
Red Santa at £2.45 for 10
|
|
|
P&P at 50p per pack to a max of £3.00 |
xxxxxxxxxxxxxxx |
|
|
Total
amount to pay |
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