INSULIN DEPENDENT DIABETES TRUST

 

OCTOBER 2002 NEWSLETTER

 

 

AT LAST – THE HIGH QUALITY EVIDENCE!

Cochrane Review comparing ‘human’ and animal insulin – July 2002

 

On July 22, 2002 the Cochrane Collaboration published a systematic review of the research carried out to compare synthetic human insulin and natural animal insulins from 1966 to May 2002. It provides the following evidence:

·        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.

 

 

GENETICALLY PRODUCED DRUGS CAN CAUSE SEVERE SIDE EFFECTS – A SURPRISE FOR THE EXPERTS!

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.

 

DEPRESSION AND DIABETES

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.

Depression and HbA1cs

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.

How do you know if you are depressed?

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.

How does depression affect people with diabetes?

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!

 

 

FOR OUR AMERICAN MEMBERS

Medicare News

Cover for glaucoma testing

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.

Cover for nutritional therapy

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.

 

FOR OUR CANADIAN MEMBERS

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.

 

 

DRUG AND DEVICE WARNINGS!

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.

 

Zyban - New safety precautions from Committee on Safety of Medicines

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.

 

Device Alert - Medical Devices Agency [MDA], 10 June 2002

Lilly HumaPen Ergo insulin pens

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

 

FDA issue new warnings about Avandia and Actos

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.

New Warning from the US Food and Drug Administration [FDA] 26.4.02

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.

What is coeliac disease?

·        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.

What are the symptoms?

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.

Diabetes and coeliac disease

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.

What is the treatment?

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

 

PHARMACEUTICAL INDUSTRY NEWS

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.

 

 

A NOTE FROM THE EDITOR

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 whol