For many years only doctors have been allowed to report suspected adverse reactions to drugs and there has been a gross under-reporting - the Medicine Control Agency estimates a 90% under-reporting and a recent National Audit Office report that less than a quarter of adverse reactions are reported. The reporting of suspected adverse reactions or side effects to drugs forms a major part of checking on the safety of the medicines we take. This gross under-reporting must mean that our system for monitoring the safety of drugs and the adverse effects that they may cause is, at best, less than satisfactory and at worst, failing to protect the very people for whom it was designed – us.

The National Audit Office report says that warnings about the side effects of medicines are failing to get through to doctors and the public. While pointing out that less than a quarter of adverse reactions are reported, it also reports that hospital doctors are particularly bad at reporting. They say that they don’t have the time, the system is not user friendly or they don’t think it is their job. Busy we can accept, perhaps we can also accept that the system is not user friendly but ‘not their job’ – is not acceptable! The system has relied entirely on doctors reporting suspected adverse reactions, so it most certainly is their job! This is particularly unacceptable in Type 1 diabetes where the hospital doctor is responsible for prescribing the type of insulin and yet may not see reporting adverse effects as his/her responsibility. Who do they think is responsible?

Before a drug receives a marketing licence it has been through clinical trials which in total, probably only include about 1500. These people may be highly selected and not typical of the wider population that will be prescribed the drug, so adverse reactions may well not show up at this stage, especially any unexpected ones. They mainly show up after a drug reaches the market when it is used on greater numbers of people over a longer period of time - sometimes it is not until a drug has been used for many years, making constant surveillance essential.

We looked at published figures from 1990 and even then, the US FDA Drug Review, Post-approval Risks 1976-1985 said: "Of the 198 drugs approved by the FDA between 1976 and 1985 for which data were available, 102 (or 51.5 percent) had serious post-approval risks, as evidenced by labeling changes or withdrawal from the market. The serious post-approval risks are adverse reactions that could lead to hospitalization, increases in the length of hospitalization, severe or permanent disability, or death." This clearly demonstrates the need for an effective system for reporting and collating adverse effects to drugs.

In the UK suspected adverse reaction reports are collected and monitored by the Medicines Control Agency [MCA] who have the powers to issue warnings about drugs and in the worst cases, to withdraw them from the market. IDDT has publicly questioned the independence of the MCA for two reasons. Firstly, because its expert advisers are often the very same experts who carry out drug company research or have some other connections – at the last count this applied to 72% of the MCA experts. Secondly, because it is funded by fees from the pharmaceutical industry and the National Audit Office report also highlighted its concerns that the role of the MCA in protecting public health could be compromised as it is wholly funded by pharmaceutical industry fees.

The key word in reporting adverse reactions is ‘suspected’

Over the years IDDT has written numerous letters to the MCA about the adverse effects of synthetic insulins and members have written to MPs to say nothing of informing their doctors and healthcare professionals but the overwhelming feeling is that none of us have been truly listened to. The only adverse reactions that are acknowledged at all have been related to hypoglycaemia but then this acknowledgement has not been acted upon otherwise we would see many more people being offered animal insulins when they report their loss or reduced warnings of hypos.

As many of us know, there is a whole list of other adverse effects commonly experienced with GM insulins that are ignored. Recently IDDT’s Co-Chairman, Dr Matthew Kiln wrote yet again to his MP to highlight ALL the adverse effects but the response from the Dept of Health was that they had no reports of them. So either our doctors have not listened to our reports, have not believed us or have simply not bothered to report them. Perhaps they simply cannot believe or understand that extreme lethargy, mental confusions, joint pains and headaches can be caused by synthetic ‘human’ insulin. But that is not the point – to report adverse reactions, they don’t have to prove that they are caused by the insulin, just that they SUSPECT that they may be.

The system has certainly failed us, the people that have suffered adverse reactions to synthetic insulins.

We don’t know why synthetic insulins affect some people adversely but they clearly do because the problems disappear with a change to animal insulins. It is not our job to know why – that responsibility rests with the MCA and the insulin manufacturers but they can only take action if they receive the reports of adverse reactions. This takes us back to square one, the failure of doctors to report our adverse reactions. But now this can be remedied because at last the government has decided that the people who actually experience the adverse reactions can also report them!

You should report suspected adverse reactions to NHS Direct who presumably pass them on to the MCA. It is important that all the people who have experienced side effects or adverse reactions to GM synthetic ‘human’ insulin do this to give a far more complete picture of ALL the adverse reactions than there has been over the last 15 years.

The Dept of Health has frequently informed IDDT that they continue to monitor the safety of insulins, so it doesn’t matter how long ago the adverse effects were experienced – report them now!

Your help is vital. It is essential that our adverse reactions are recorded if we are to continue to maintain supplies of animal insulins and prevent others suffering as many of us have done.

In March 2003 IDDT mailed over 35,000 GPs with a letter from Dr Matthew Kiln, not only IDDT’s Co-Chairman but a GP with diabetes who cannot tolerate GM synthetic insulins. We included an A4 poster explaining the adverse effects, the types of animal insulins that are available in the UK and advice on changing from synthetic to animal insulins. In doing this we are aiming to provide GPs with easy access to helpful information so that they can help and support people with diabetes and enable them to have an informed choice of insulin treatment. A copy of this poster is enclosed with this Newsletter to all our UK members and diabetes specialist nurses. You can help by taking copies to your GP or pharmacy. Just let us know how many posters you would like by contacting:

IDDT’s October Newsletter reported that drug regulatory bodies had again issued warnings about these two drugs. They are:

• Not to be used in people with heart failure, fluid retention or liver disease
• Not to be used with insulin.

Despite these warnings, IDDT continues to receive calls from people who have been prescribed Avandia or Actos in addition to their insulin. We can only repeat our previous advice that if you are taking insulin and have been prescribed Avandia or Actos, you should discuss this with your doctor straight away. On requesting a change to animal insulin, one lady was told by her diabetic clinic to ‘try Avandia with your present insulin. It’s not licensed for this use but we’re trying it’!!! Needless to say, the lady refused but still didn’t manage to persuade them to give her animal insulin!

Avandia next stage - the manufacturers of Avandia, GlaxoSmithKline, have just received the approval for Avandamet in the US and they say they are committed to making it available in the UK. This is a combination of Avandia and metformin. It is worth remembering that the Canadian Therapeutics Initiative states that "Long-term trials are required to know whether this class of drugs [Avandia and Actos] reduce morbidity and mortality." Yet before this is done, the manufacturers produce another similar drug and the US regulatory authority happily approves it a year sooner than even the drug company expected! Avandamet is expected to help sales of Avandia to reach £1.5billion by 2006!

Diabetes Update [Dec 2002], Diabetes UK’s magazine for doctors and nurses, informed them that the Cochrane Review [July 2002] comparing ‘human’ and animal insulins highlighted that the "past research carried out leaves many gaps". Update goes on to say: "the most serious of these omissions is that there was little quality research into patient focussed outcomes, such as health-related quality of life or diabetes complications and mortality prior to the launch of ‘human’ insulin in the 1980s"

Is this spin we are used to from politicians? The review actually said that the majority of the research was "methodologically poor" – rather different from Update saying "there was little quality research". Doesn’t this sound a lot better than ‘methodologically poor’!

But Update is also incorrect and misleading! The last few words ‘prior to the launch of ‘human’ insulin in the 1980s’ are wrong – the review looked at research from 1966 to May 2002 and not just the research before the launch of ‘human’ insulin in the 1980s. This is a very important difference because it means that vital good quality research was not done before or in the 20 years since the launch of ‘human’ insulin, despite all the adverse reaction reports during those years. Is this spin or does Update/Diabetes UK totally misunderstand the nature of a Cochrane review.

Not until the March/April 2003 edition of Balance was there any information about the Cochrane Review [July 2002]. Yet again there are omissions [or spin] when it says "The review pointed out that there had been minimum quality research into such issues as quality of life" so missing out that the research had not looked at comparing complications or mortality using the animal and ‘human’ insulin. These are very important issues to people who have to use insulin if they are to be able to make informed choices about their treatment.

At the time of writing, Diabetes UK has not informed members or professionals that Novo Nordisk have re-considered their strategy and are going to continue to supply their animal insulins. But nor have any of the leading diabetes journals, not even as a news item. Why not?

A mark of her generosity was that in the last few months of her life, Beatrice donated £1000 to help the children with diabetes at the Dream Trust in India.

Beatrice was one of the very few people, if not the only person, in Eire using animal insulin. She tried synthetic insulin when it first appeared but suffered many adverse effects so fought to return to animal insulin even though it was no longer licensed in Eire. In the last three years of her life she published her little book, ‘Diabetic Commonsense’ and gave it to IDDT to distribute freely. The book received huge praise because it rings bells for so many people with diabetes and shows that managing diabetes is just as its title – common sense.

She saw fashions in the treatment of diabetes come and go and she recognised the role of the pharmaceutical industry in this. She knew what suited her and her diabetes and she was assertive enough to maintain the treatment she wanted. She never forgot the early teachings of Dr Lawrence, most of which hold true today and they certainly worked for Beatrice. Diabetic common sense enabled Beatrice to live with her diabetes for over 70 years and her book is her legacy to all of us. She will be sadly missed.

We have argued long and hard that synthetic GM produced ‘human’ insulin should not be called ‘human’ at all. Some people have even debated whether or not it should be called insulin because it isn’t actually insulin, it is a synthetic copy of the insulin the human body should produce. Well, maybe the answer has been provided from an unlikely source. In a media release from NICE about pump therapy, Lantus, the new 24hour acting synthetic insulin analogue, is described as "an insulin like medication". Much better!

The response to the article about supplements was tremendous and we would like to thank everyone who took the time and trouble to write to us. We will be putting together a further article for the next Newsletter.

Also thanks to everyone who responded to the requests for your experiences with diagnosis and candida. The members concerned are grateful for all your help.

IDDT’S 2003 Annual Meeting will be held on Saturday and Sunday October 11^th and 12^th. We will supply further details nearer the time but please put these dates in your diary.

Lantus [glargine] made by Aventis is the new, much advertised 24hour insulin analogue that is said to have no peak of action. In our January 2003 Newsletter we gave a cautionary note that this a new insulin and like all new drugs we have to see what happens when used in much larger numbers of people and over a longer time. The first changes to its use were made in December 2002, when Lantus received European approval for use in children over the age of 6years and for flexible injection times. [Perhaps an attempt to avoid the early morning hypos?]

Lantus is being well received by the medical profession - many people are being changed to it even when they are having no problems with their existing insulin. Some people who ask for a change to animal insulin are being indirectly or directly refused but given Lantus instead. Unfortunately some are being given misinformation and told that Lantus is not synthetic or a GM insulin. Of course it is, it is made by a process that uses a transformed E.coli K12 host strain!

Lantus does sound like the answer to a prayer – one injection a day of long-acting with no peak of action and a reduction in night hypos, or so the blurb says. But we have received a lot of concerns from people using Lantus and you will read two in ‘From Our Own Correspondents’ - one person who thinks Lantus is the best thing since sliced bread and one just the opposite. In reporting this, we are very aware that people having problems are far more likely to put pen to paper than those who are happy with their new Lantus, but once again this demonstrates that people are different and what suits one person does not necessarily suit another.

It is important to note that the following reports came from ‘human’ insulin users and animal insulin users:

Some good ones - no peak of action is much better and one report where hypo warnings are present at 3.2 but were rarely present on ‘human’ insulin.

• Similar adverse effects on Lantus to those experienced with ‘human’ - headaches, extreme tiredness, mental confusion etc but on returning to animal insulin these have disappeared.

• a very noticeable problem reported by quite a few people is painful joints and swelling of joints and hands within a short time of starting Lantus. This disappears with a return to their normal insulin.

• Hypos in the early morning ie 6.00am as opposed to the middle of the night but the the Patient Information Leaflet warns of this. However, as one person said, if you are asleep, early morning hypos are not a lot different from night hypos and nor do they make you feel very good to begin a day’s work!
• Sudden hypos at strange times with few warnings.

IDDT found these reports not only of concern but disappointing because we also hoped that Lantus would be wonderful and hoped it would be the ‘synthetic’ answer for people who can’t use ‘human’ insulin. So we looked further, to the European approval papers and to the NICE Guidance for Lantus:

Lantus was recommended for marketing authorisation subject to chemical, pharmaceutical and biological, as well as clinical follow-up measures being undertaken by the company, Aventis. The document makes it clear that "major safety issues were identified" and so the licence was granted providing the company followed these up.

The document itself is scattered with expressions such as ‘it is likely that’, ‘it is assumed that’, ‘it is not expected that’ – assumptions rather than proof which sounds familiar!

It should be noted that in trials Lantus was only compared to ‘human’ long acting insulin [isophane or NPH] either injected once or twice daily. However the Agency concluded that:

Lantus is comparable to other long acting insulins in type 1 and Type 2 diabetes and HbA1cs were about the same. So as yet it has not been shown to be better than other insulins – just comparable.

• After injection Lantus is left under the skin [called the depot effect] for slow release. Studies in rats, mice and dogs showed that the period during which Lantus is released from the injection site increased with increasing dose. Our Question - so presumably the bigger the dose, the longer it lasts?

• Studies to look at the absorption of injected Lantus showed that after 24hours 50% of the insulin was still left at the injection site and after 48hours the amount of Lantus still left at the injection site was 20%. Some of the insulin may be metabolised at the injection site but no studies were performed to address the question of the possible accumulation of active insulin and its metabolism at the injection site and the document stated that this was a point of concern. The manufacturer agreed to carry out follow up studies to address this [once it is on the market.] Our Questions – So is Lantus a truly 24hour insulin or actually a 36hour insulin? Does the overlap of absorption from one day to the next account for the unexpected hypos?

• In rats and dogs there were changes at the injections sites including subcutaneous fibrosis, sclerosis and inflammation. Malignant Fibrous Histiocytomas were found in both rats and mice at the injection sites but this was not related to the dose but the low acidity of the Lantus solution. Apparently these tumours are commonly found in subcutaneous tissue when solutions that are not neutral are used. There was no evidence of local cancers in humans. Our Question – should this not have been investigated further BEFORE Lantus was given approval, especially as we know that one insulin analogue was scrapped before reaching the market because it caused tumours? Shouldn’t people using it be told of this risk, however small?

• In studies where hypoglycaemia was induced in healthy people and those with Type 1 diabetes, Lantus and ‘human’ insulin had similar neuroglycopenic [effects of hypoglycaemia in the brain] and counter-regulatory hormone responses. Our Question – so does this mean that people who have problems with hypos and loss of warnings with ‘human’ insulin will also have problems with Lantus?

• If people had previously used a regime of injecting their long-acting once a day, then there were less night hypos with Lantus. But if people had previously injected their long-acting insulin twice a day, morning and evening, then there was a greater increase in hypoglycaemia with Lantus even with a 20-25% reduction in dose of Lantus.
• After the initial phase, the frequency of hypos with warnings and the incidence of severe hypos were the same with Lantus and ‘human’ long-acting insulin. BUT there was a higher incidence of hypos without warnings in people using Lantus. The document says that Lantus is as safe as ‘human’ insulin. [wry smile!]

• More pain at the injection sites with Lantus.
• As there is still some insulin left at the injection site after 24hours, this prolonged exposure of relatively small areas of tissue may result in local toxicity. Careful post marketing surveillance is recommended to monitor the appearance of serious local reactions.
• Direct quote: "The occurrence of injection site Malignant Fibrous Histiocytomas in rats in pre-clinical studies raised concerns as to the carcinogenic potential of Lantus but following careful evaluation of the relevance of these findings, it was concluded that at present the carcinogenic potential is not a point for particular concern. However, in view of the lack of clinical experience following long-term exposure to Lantus careful post-marketing surveillance will be required in order to monitor the appearance of more serious local reactions."

This was not a major concern.

Two of the four studies investigating the incidence of retinopathy showed a significant increase in retinopathy in patients treated with Lantus although when the four studies were put together and analysed there was not a ‘meaningful difference’ between Lantus and ‘human’ isophane/NPH. This could be linked to better control with Lantus as initial improved control has been shown to increase retinopathy in previous studies. However, the document says that ‘during the clinical trials, the influence of Lantus on ocular safety is unclear’ and so the manufacturers provided experts who concluded that there is no reason to suspect that there is an increased incidence of adverse ocular reactions associated with Lantus treatment.

The NICE appraisal of Lantus, published in December 2002, looked only at blood glucose control, hypoglycaemia and cost effectiveness. It makes no references at all to the other ‘major safety issues’ of the European Medicines Evaluation Agency. Somewhat worrying!

But let us not pre-judge or be too negative! It is early days and we must wait for independent post-marketing research to give us the complete picture. No doubt Lantus will suit many people but the one thing we do know even at this stage, is that Lantus is not the answer for everyone and so there is still a need to maintain the full range of animal and synthetic insulins to suit all needs.

We also must not forget that the European document did not mention the adverse effect that has been reported to IDDT by several people – joint pains and swellings. Now that patients can reports adverse effects themselves to NHS Direct, it is especially important that they report these as Lantus is a NEW insulin and these same symptoms have never been addressed in relation to ‘human’ insulin even after all these years!

Remember! If you come under pressure to change to Lantus, you do not have to change. If you don’t like saying no to your doctor or DSN, you can use a non-aggressive approach by saying that as it is new insulin, you will wait for post-marketing research.

In the last Newsletter we expressed the feelings of many of our members and callers about being ‘blocked’ from seeing the consultant by their diabetes specialist nurse[DSN], especially from people who felt their request to change to animal insulin was being refused by the nurse rather than the doctor. We also had concerns about the misinformation people were being given about animal insulins eg ‘they’re dirty’ or ‘not available’. The Royal College of Nursing informed us that DSN’s are not allowed to prescribe and suggested that we should write to their Diabetes Forum. This we did and received a full and helpful response from their Chairman. Marilyn Gillichan as follows:

• Nurses are not allowed to prescribe but it is well known that they have great influence over prescribing decisions.
• Patients do not necessarily need to see a doctor for an insulin prescription to be arranged. The DSN may discuss treatment options with a patient and make a prescribing recommendation to the doctor.

• People who have a preference for one or the other should receive appropriate and informed advice and support from their healthcare professionals.
• We acknowledge that, because the huge majority of prescriptions are for ‘human’ preparations, some DSNs may be less well informed about the animal insulins that are available.
• This issue was covered at the Forum conference last year and will be covered in greater depth this year.

In addition to this, the Forum has submitted an article for publication in the Journal of Diabetes Nursing which they hope will raise awareness of our concerns and help to improve the experience of people with diabetes. We are grateful to the Diabetes Forum for their assistance.

It was right that IDDT’s January 2003 Newsletter was full of the good news that Novo Nordisk have revised their strategy and are going to continue to supply their pork insulins to the NHS in the UK. But while we were feeling relieved at the news, imagine how our members abroad felt when they read about it. While they are denied the animal insulins they need, without exception, they are pleased for people in the UK. But at the same time they feel angry, upset and unfairly treated as their needs are just as great as people in the UK who cannot use GM ‘human’ insulin.

AUSTRALIA

One lady typical of people that are denied access to pork insulin is importing it from CP Pharmaceuticals at a cost of $1400 a year as the cost is not covered by the Australian National Health Scheme as it would be for GM ‘human’ or natural beef insulins. She is not the only one – we had an influx of correspondence from people in Australia who feel angry, upset and discriminated against. Only beef and synthetic insulins are available in Australia and not pork which Novo Nordisk discontinued almost overnight in 1991.

So can people in Australia do anything? As pork insulin has already been removed from the market, the battle to get it back is an uphill struggle but in the UK, the US and Canada it is still available so we are fighting for it to be retained. But doing nothing, no longer seems an option for people in Australia! The Cochrane Review, showing no evidence that ‘human’ insulin is superior to animal and Novo Nordisk change of strategy to continue to supply animal insulin in the UK, has mobilised and incensed people in Australia. They are planning to lobby for the animal insulin they need to maintain good health and quality of life. So if you live in Australia and you want to help people who need pork insulin, watch this space!

• Larraine Ingram, PO Box 3041, North Rockhampton Shopping Fair, QLD 4701

Eli Lilly has announced that they intend to discontinue its range of animal insulins in India at the end of 2003 although 50% of people needing insulin use animal insulins. The Chairman of Lilly India is quoted as saying ‘Throughout the world animal insulin has already been phased out’. This is simply not true but sounds persuasive! Lilly still supply pork insulin in the US and Canada. However, at the same time they announced that they are cutting the price of their ‘human’ insulins by 33% to be the same price as their animal insulins. It was also announced that they are planning to conduct trials of inhaled insulin in India, although they need the government’s permission to be able to do this.

Novo Nordisk have announced the withdrawal of their pork lente insulin – a further reduction in choice for doctors and patients in Switzerland.

We would like to thank all the people who send us in-date unused insulin and especially all the diabetes specialist nurses who take the time and trouble to regularly send us supplies. A huge thanks also to goes to all the people who have joined our scheme to sponsor a child or young person at the Dream Trust. All our supplies now go to the Dream Trust in India, a diabetes clinic for children and young people with diabetes run by Dr Sharad Pendsey and his wife. Some of these children would die without your help but with your sponsorship and insulin supplies, greater numbers of children are now able to receive treatment and insulin. Special thanks go to the pupils of Repton School in Derbyshire who donated £500 from their annual fundraising event to sponsor a little girl. She is now one of the few children who tests her blood sugars instead of urine testing.

Then there is Nitesh who is one of the children being sponsored by IDDT members. He is 10 years old and is on two injections a day and occasionally tests his urine. His father died in 1995. He has an older brother and sister who are studying. His mother works as a labourer in the fields and earns around £12.00 a month. Nitesh’s insulin and treatment costs £17.00 a month.

The kingdom of Saudi Arabia is considered as one of the countries where the incidence of diabetes is rising considerably. Studies showed that 10% of the population has frank diabetes mellitus, while 10% are diagnosed as having glucose intolerance which means they are liable to become diabetic. There is no doubt that 20% of the Saudi population will get diabetes in the near future. The incidence of diabetes in Saudi Arabia does not differ very much those in different gulf countries with the highest incidence found in Qatar and the lowest in Yemen. Diabetes mellitus is one of the chronic diseases that accompanies the patient all through his/her life and it has acute and chronic complications.

1. Diabetic ketoacidosis: one study done in Riyadh city (the capital of KSA) showed that 55% of acute complications of diabetes are due to diabetes ketoacidosis and 15% of those patients presented by coma.
2. Tendency of coagulation is increased in diabetics due to increase in a substance that antagonize the action of antithrombotics (increase level of plasminogen activator inhibitor). It is a fatal complication, but no study has been done to detect the magnitude of problem. Roughly, 80% of patients who present with this complication die
3. Hypoglycemia: no studies have been done to determine how common this is. Although it is a common complication of diabetes, it is not common among Saudi diabetics because most people are not undergoing tight glucose control. The social habits, like eating dates with coffee at different times of the day, mean that the patients are in a state of hyperglycemia most of the day

These types of complications are responsible from most of the causes of morbidity and mortality among diabetics. Studies done in Saudi Arabia proved that the complications compete with the disease itself in consuming the health resources. We will go through some statistics to show the magnitude of the problem in Saudi Arabia.

1. Diabetic neuropathy: this is the most common complication with 15% of the newly diagnosed cases having some degree of neuropathy. This rate could reach 50% after 10 years from having diabetes. In 1993, a telephone survey carried out at all hospitals of Riyadh showed that in one day there were 36 amputations carried out due to diabetes and the hospital admission duration for those patients was 36 days.
2. Diabetic eye disease: diabetes is one of the important causes of cataract and glaucoma in diabetics. Studies have shown that in Saudi Arabia 62% of cataract cases were due to diabetes but there are no studies to show the rate of glaucoma among diabetics. Diabetic retinopathy is the first cause of blindness in Saudi Arabia. A study at the King Saud University at Riyadh with 2000 diabetic patients showed that 17% are affected by retinopathy, 12% of cases need photo-coagulation therapy. A study done in cooperation with King Khalid Eye Specialist Hospital in Rhydah has shown that 4000 people with diabetes are registered as legally blind annually [defined as visual disturbance to the level which do not allow the individual to drive a car].
3. Vascular complications:

• Coronary angiopathy: diabetes is the first cause of heart attack in Saudi Arabia and 50% of patients admitted to the coronary care units have diabetes. Mortality among those patients is 80%.

• Cerebral angiopathy: a study done in Riyadh showed that 73% of cerebro-vascular-stroke (CVS) happened in diabetics

• Peripheral angiopathy: there have been no studies to detect the incidence of this complication

• Obesity: there is a high incidence of obesity in the Saudi community. Epidemiological studies showed that 23% of men are suffering from morbid obesity [body mass index above 40] and 17% from obesity. There is a high incidence women, 32% have morbid obesity and 19% are obese.
• Hypertension: studies showed that 29% of diabetics suffer from hypertension which increases the risk factors for cardiac diseases.

• Dyslipideamia: a study done in Riyadh on over 1000 diabetic patients showed that 27% suffer from high cholesterol levels.

• Diabetes with gestation: the incidence rate of gestational diabetes is triple the international rate with 10% of pregnant ladies suffering from diabetes. There is recurrent pregnancy in Saudi women, obesity and prolonged fertility life (most of Saudi wives have more than 5 child) and most of them continue to produce children above 40 years old (social stigma).

According to the researchers, converting part of the liver to pancreas should not affect normal functioning of the liver. They also say that this is the first stage and there is a lot more work to be done but in the future it could mean a cure for Type 1 diabetes by a single injection.

I had started to have pains in my hands and feet early in 1999 and eventually got to see a rheumatologist who diagnosed chiro-arthropathy and yep, no one else has heard of it either! Basically the tendons had thickened and that’s what was causing the pain.

This terrible toothache like pain just got worse with painkillers doing nothing, anti-inflammatory tablets would at least relieve it for short periods. The pains went on into my hips with the rheumatologist telling me it was the same condition. I found this very scary and asked him how far he thought this would go? He made his hands into a claw and said "you will end up like this eventually."

Full-time work became impossible as I found that if I worked 4 days a week it would take me 4 days to recover. I was becoming completely debilitated and for a 30 year old I started to resent being unable to do as much as my mother did when she is twice my age!

My retinopathy took 8 major sessions of laser treatment to curb it and at least I hadn’t lost my eyesight yet. I feel very lucky because I find my ophthalmologist brilliant. He told me he could save my sight but that my driving licence would probably be taken off me in the next 3 years. I found this totally devastating, as I could not go very far without my car -walking a mere ½ a mile could stop me moving at all for 2 days.

I’m a tough cookie, as I constantly get told by my family, and don’t usually let things like this get to me but after 3 years I was very close to the end of my tether. My diabetes consultant started talking about the new insulin’s due to come out but whilst I waited he tried 4 other insulin’s to see if we could get a decent level of living. One of these, Insulatard had me hypo every night for 3 weeks and sleep is impossible when your comatose! The sugar levels where perfect on the HbA1c at 6.5 but the general day to day living with a blood sugar that does exactly what it wants to do rather than me having any control started, to take its toll.

So again the official classification came "you’re a brittle diabetic". I had never really understood the term until I had to live with it. My sugar levels could be anything from 0.9-17.6 and I was completely unaware of it. I had to test my sugar each time I wanted to drive and if it was below 6 then I wouldn’t drive until I had had something more to eat. Then I would only drive for a maximum of 20 minutes so day trips were out of the question.

The worse days were when I couldn’t get the sugar level off the floor. Typical of one of these days was when at breakfast time I had tested and my sugar was 2.4 so I had some extra breakfast. I drove the minute to my parent’s house to pick up my mother to go shopping. Whilst having a cuppa she said "Are you low? You’re slurring your words." So I had a chocolate biscuit and 2 more slices of toast and we drove to the supermarket, a whole half a mile away. In the second aisle I went hypo again and downed a bottle of Lucozade. We drove back to my house and I had an extra 40 grams of carbohydrate with my usual lunch and another bottle of Lucozade. My mother went home only to have to come back 2 hours later because I had gone comatose. Pretty difficult for most people after having loads of carbo’s, 2 bottles of Lucozade and not taking the usual dinnertime insulin dose. The kickback came that evening and eventually my sugar levels went back up to 17 this time!! So I now felt like a 30 year old living in a 90 year old body. As my youngest son once said "your body hates you, doesn’t it?"

My whole life changed because I read the Daily Mail article on ‘human’ insulin and the problems some people were having with it. Out of the list of side effects I had them all but the violent mood swings and mental confusion – hmmmm, not really sure about the last one!

Well, jumped through hoops with my GP and consultant to achieve the outcome I wanted…….being changed to animal insulin. Interestingly my consultant had been extremely upset by the Daily Mail article; he believes that the cases stated were untrue. He was also profusely apologetic to me that he had not suggested to me that my problems might be due to the synthetic insulin. – 4 times he apologised! So back in my good books we discussed the possibility that my ‘major’ problems may be caused by synthetic insulin. He agreed to prescribe animal insulin although he did state that other diabetic patients with these problems had not any major differences after changing back.

I have started my animal insulin and within 24hours I started to feel ‘different’, there’s no other way of putting it. Within 36hours the terrible fatigue had disappeared and I slept well for the first time in 4 years. I also realised that the general stiffness including all its pain had gone and I was actually starting to feel human again………WHOOOO HOO!

I just can’t get over how much difference has occurred since going on to animal insulin. When I changed, my readings did go up from an average of 3.3 to a maximum of 15.6 as I expect that the animal insulin took a bit longer to kick in. I have decided to stay on the same dose for a week and only then will I start adjusting upwards if necessary.

I’m just so happy to feel this good again and even though it’s not 100% yet, I’m just taking each day as it comes. Thanks a great deal to you and the Daily Mail article.

Just had to tell someone!! I’ve lost half a stone in a month. WOW!!

Been to my family planning clinic this evening where there is a doctor who works with the local diabetic consultant. Told her of the wonderful changes that have happened to me since changing to animal insulin and the only reaction was "I didn’t think they made beef insulin any more." My admiration for this lady took a complete nosedive.

After doing a miriad of tests I’ve come to realise that the short-acting pork insulin is not working very well in the mornings because I have had to double my dose although at teatime it seems to work properly. After two weeks of fairly even control things did a major downturn with 19 hypos in 22 nights. I have agreed to try the new Lantus insulin alongside pork Actrapid and was told that without trying this, I would not get on the islet transplant list.

Having tried Lantus for 3 days, I suffered terribly with swollen hands and I very quickly changed back to animal insulins. My consultant was very dischuffed but it’s going to take a humungous effort by any of the so-called experts to get me off animal insulin again. After changing 6 times in a year and being happiest with animal insulins, I’m very unwilling to change again.

I have just spent 3 days in hospital with a severe chest infection and being an inpatient for the first time in 12 years has made me vow never to go back in! Telling the nurses that I was hypo was the easy bit but telling four of them and still getting no help/food/Lucazade wasn’t and I promptly passed out in front of them. At 35 and after 30 years of diabetes, all I wanted was understanding not patronisation. The general nurse training needs to include that if a diabetic patient says they are hypo, then get them a sugary drink immediately.

At last I’ve cracked it! It has only taken me 5 years to realise that I suffer with a condition known as insulin dumping. It seems that my body stores it up somehow and then dumps it in the blood stream at 3.00am and 3.00pm. This only happens with the short-acting insulin and it doesn’t seem to make any difference which short-acting I use as the body does the same thing with each one. So now I don’t take any insulin after lunch and no more night hypos!!!!!!!!!

A final word:

To GPs, consultants and specialist nurses I would say that we don’t want to hear the pharmaceutical companies’ blurb word for word, we want straightforward information so we can decide what is best for us.

• By March 2006, all GP practices should have diabetes registers and everyone will have a systematic treatment regime based on an agreed care plan, regular reviews of care, education and a named personal contact within the healthcare team as part of working with specialist services. From 2006 every person with diabetes, or those at risk of it, will be offered regular appointments with medical staff to try to ensure that any complications are detected promptly.
• From 2007 all Primary Care Trusts [PCTs] will be required to provide eye screening for everyone with diabetes. Ministers say this will prevent at least 1000 people a year from blindness.
• During 2003 and 2004, PCTs are expected to set standards of care, measurable targets and build up staffing capacity to enable the NSF standrads to be carried out. Local people are expected to be part of planning of local services.
• The appointment of a National Clinical Director for Diabetes and that people with diabetes should play an active part in establishing local services and priorities.
• The deadline for the other targets is not until 2013 and PCTs are expected to set targets for these during the years prior to 2013 but are expected to make an immediate start on all standards that will result in ‘tangible service improvement from 2003/4’.

As the NSF strategy leaves it up to local PCTs to decide on the best way to deliver the standards one has to wonder if the aim of equality of care across the country is going to be achieved. But the major problem has to be that the government has failed to set aside money to provide the extra services and the necessary trained staff to deliver them.

Type 1 and Type 2 diabetes really are two quite different conditions and IDDT suggested initially that perhaps there should have been two separate NSFs. If this had been the case the NSF for Type 1 could have been produced sooner. As there is a strong link between obesity and Type 2 diabetes may be a strategy to tackle obesity should have been developed with an NSF for Type 2 diabetes.

Latest News: On February 26^th the government announced that it is setting up nine pilot sites to introduce blood glucose screening for people at risk of Type 2 diabetes. Two studies will take place in these areas, one will look at the benefits of screening groups at high risk of developing diabetes and the other at the practicalities of screening for diabetes and cardiovascular disease. Also announced was the appointment of Dr Sue Roberts as the new National Clinical Director for Diabetes.

Purchasing our new home proved quite demanding – selling our previous property, liaising with our Scottish solicitor at distance throughout the purchase procedure, sorting out many problems and delays during the completion etc. Then came the preparations to leave – packing and goodbyes. We travelled up overnight, a journey of some 12 hours, in order to collect the keys at 9am on the day our new "treasure" became ours. Needless to say, only half the central heating radiators worked, and up here when it is cold it is cold!

The general stress involved in moving home, the long journey, the lack of sleep and problems with the property all took their toll. In the early hours of the morning during our third night I had the hypo of all hypos! My wife who is very experienced in dealing with these situations could not revive me. Eventually however she got me round but let us not forget she had also been subjected to all the same strains and conditions and was now faced with a further night of virtually no sleep, worry about me and general intrusion to her well being. She was not, as the saying goes, a happy bunny.

This was a severe hypo by my standards. When I eventually started to regain some awareness I was ridden with sweat, I could not voluntarily move my legs, my fingers would not "co-ordinate", my speech was so slurred I could not be understood and I felt terrified.

Of course, all came back to full working order but I felt dreadful and disorientated for the whole of the next day and picked up very slowly. I realised that I had been very lucky. To add to the worry of the hypo I started to consider the problems in the future as my wife would have to return to England every third week for five days to ensure her business continued to run on track.

Then I found myself asking the question what if she had been away. Now this may not be an issue in normal circumstances but our new home, as pretty and charming as it is, is situated in the middle of nowhere. The nearest village is some half mile or so away. We are surrounded by beautiful views - but no nearby people or help available, just me and our four miniature dogs.

Immediately I started to consider the precautions I should take and came to the conclusion that during those times that I am alone I would try to run my blood a little higher overnight. We decided that my wife would telephone me first thing in the morning to ensure that I am up and about. Should she not be able to get a response from me she can then telephone our surgery for assistance. Having first spoken with them about this I found them very understanding and they offered every help.

This has led me on to consider my wife’s position and indeed that of any carer. I really don’t know that I would be able to do what she does. Let us consider an advert if we were to offer the position out hypothetically:

I really cannot imagine getting a reply. Yet this is the role placed, if not forced, upon the carer who unselfishly and generously fulfills these requirements. While I agree and have every sympathy with the many carers whose roles have been brought about by other medical conditions, some far more traumatic, it still does nothing to reduce the burden placed on the carer of the diabetic. I regret that I have not said thanks often enough. How grateful am I for my life? That is just how important their care, love and devotion is.

I feel better now that I have written this article and while preparing it I have come to the conclusion that in my own personal dictionary of life carer is not the correct word. Perhaps Hero is far more appropriate. Sadly for these Heroes there are no medals, certificates or rewards presented in honour and recognition of these kind people who so generously give up much of their own lives in order that we can enjoy more of our own.

NJF

It is not unusual for IDDT to receive reports from people using insulin that they are being advised by their GP practice to use less blood testing strips, surely false economy if it could mean one night in hospital!

Costs - a bottle of 50 strips is around £14.52. If someone tests 4 times everyday, the annual cost is £423.98. But someone with Type 2 diabetes is likely to test a couple of days a week or one day a week at different times and then the annual cost is only £100.

Member reports - his GP practice has decided to remove blood testing strips for ALL people with Type 2 diabetes NOT using insulin. Their leaflet says:

The doctors are correct about the research - it does show that home blood monitoring does not improve overall control and this applies to both Type 1 and Type 2 diabetes. A systematic review [ref 1] looking at the needs for blood glucose self-monitoring did conclude that it might not be essential for everyone with diabetes.

• Only 3 out of 18 studies looking at Type 2 diabetes showed any improvement in control by carrying out blood sugar tests as measured by the HbA1c test when compared to urine testing or no testing.
• In Type 1 diabetes, somewhat surprisingly, only one study out of 24 showed an improvement in HbA1cs.

Worth noting though, that in these studies people preferred blood testing to urine testing – obviously patient preferences do not come high on the agenda of this GP practice!

"Your HbA1c tests are crucial and should be done once a year" – so if blood sugars start to go high halfway through the year but the ‘patient’ doesn’t know it because they can’t test their blood, do they run high for the next 6 months? The National Service Framework for diabetes has just announced its main aim is to reduce complications, the actions in this practice hardly seem in line with this.

Some Type 2 medications can cause hypoglycaemia – have these GPs considered this when they are saying that ALL Type 2 people will have their blood testing strips removed? Do they realise that HBA1cs are not able to detect the number of hypos someone has? If they can’t measure their blood sugars, are people supposed to guess when they are hypo? It is just as dangerous for someone with Type 2 to drive in a hypo as it is for someone with Type 1, yet these people are being denied the means of checking.

"Day to day variations in your sugars have NO part to play in our decision making" This may well be so but they do influence peoples’ day to day lives. If they know their blood sugars are high, they can take exercise or eat less carbohydrate to bring them down. If they know they are low, they can eat extra.

Some people with both Type 1 and Type 2 diabetes take no action as a result of their blood tests, they just record them to show the doctor, so perhaps blood testing is a waste of resources. But the big question is why people take no action and all too often the answer all too often is that they haven’t been taught what action to take! This is not a reason to remove their test strips, but a reason to look at better or different education. But there are many people who do rely on their blood sugar tests and take action - denying them their strips denies them their ability to try to gain better day to day control and denies them the comfort and safety of knowing what is happening to their blood sugars.

• They are being given no choice and their wishes and preferences are being ignored. It assumes that everyone with Type 2 diabetes has the same needs.
• It ignores people that are taking medications that can cause hypos and it ignores those who do take remedial action as a result of high test results.

• It means that they are refusing to prescribe strips that are available on the NHS. Do they expect people who want to continue to test to pay for a product that is available free on the NHS? Or do they expect people who want to test to change to a GP practice that will prescribe test strips?

Ref 1 Health Technology Assessment 2000;4:No 12

Gastroparesis is a stomach condition that can occur in people with diabetes whereby the gastric emptying is abnormally slow and the food remains in the digestive system for a longer time than normal. Recent research using new techniques has established that gastric emptying is abnormally slow in 30-50% of people with longstanding Type 1 or Type 2 diabetes although this delay may be only modest in some people. It is thought to be caused by neuropathy affecting the nerves of the stomach so that the stomach muscles do not work properly and also by blood glucose control.

There is increasing interest in gastroparesis because it can affect blood glucose control as the food remains in the stomach for longer than it should and this can lead to erratic blood sugars.

There has not been very much research carried out in this area but it is now known that acute changes in blood glucose levels have a substantial and reversible effect on gut motility in both healthy people and those with diabetes.

• In healthy people and those with Type 1 diabetes marked hyperglycaemia [above 15mmols/l] affects motility in every part of the gastrointestinal tract and in acute hyperglycaemia [16-20mmols/l] gastric emptying is slower when compared to normal blood glucose levels.

• In healthy people and people with Type 1 diabetes without complications, gastric emptying is markedly faster during hypoglycaemia.

In the US a company, Medtronic, Inc, have developed an implantable device that has been shown to improve the symptoms of gastroparesis. The device delivers mild electrical pulses to the nerves in the stomach which stimulate digestion. A study involving 100 patients from various countries, showed that there was a variety of responses to the device but 93% of the participants vomited less than half as many times after using the device and most of them felt better after using the device.

This treatment is called Enterra therapy and has been available in the US since March 2000.

I have just gone through the IDDT Newsletter in enlarged print. For those of us with poor sight this edition makes interesting reading, in fact pleasurable reading. I can even read it in poor light, unlike before. Congratulations to you and your team for this good idea.

I have carefully preserved all the copies of this educative and informative magazine in my study and a lot of my friends avail themselves of the copies. How I wish that one day you will have the resources to bind these enlarged print copies into a magazine. Lastly I would like to express my deep appreciation to IDDT for your concern for people, especially those of us in the third world where medical facilities and information are grossly deficient. Let me assure you that your work is helping to save and lengthen the lives of those of us in remote parts of the world. Thank you for the work you are doing for us, even though many of us lack the ability to contribute financially.

D.K. Chigo

Adult Education Agency

Makurdie, Nigeria

Jenny’s comment: The Newsletter is also available on tape so just give IDDT a call on 01604 636471 if you would like either of these versions

Dear Jenny,

Information about DAFNE [Dose Adjustment for Normal Eating] from Diabetes UK has just landed on my doorstep and it is hailed as "a breakthrough in diabetes care" and "trials have shown dramatic effects on the lives of people taking part".

I have had diabetes for over 40 years and for several years I have been using my own DAFNE system of adjusting my animal insulins according to my needs. I use beef short acting insulin and beef PZI which is very long acting insulin [lasts like the new Lantus] and this has resulted in excellent blood sugars and HbA1cs over many years and I generally feel very well.

People who were diagnosed years ago had a book with carbohydrate values of most foods [Carbohydrate Countdown] and we were taught carbohydrate contents of foods and whether these were fast or slow acting. We also were taught how to adjust our insulin doses according to our food intake, exercise and blood sugar results. It seems to me that this all disappeared when the high carb/low fat diet became the recommended treatment for people with diabetes and they were told all they had to do was eat a healthy diet.

I am extremely worried about the future of diabetes care and treatment when lessons of the past are not learnt and then are pushed as ‘New’ and this demonstrates an even greater need for IDDT.

Mrs E.B.

Jenny’s comments: Mrs E.B. is not the only person expressing these sentiments about DAFNE and we do need to remember that DAFNE was first introduced in Germany 20 years ago. It is also worth noting that for example, in the US and Canada they have never stopped counting carbs and adjusting their insulin. The UK did it in response to guidelines established in 1986 and some of us never did understand how newly diagnosed people could learn how to adjust their insulin if they did not know what they were eating, as the cornerstone of diabetes management is insulin, diet and exercise.

Several of our members are attending DAFNE courses during the next few months and we will be reporting on their experiences in future Newsletters.

Dear Jenny,

I have been diabetic since August 1948 and during the last 54 years I have seen and experienced all of the problems you talk about in your Newsletter and I particularly like your droll sense of humour!

In 1984 I was transferred to human insulin to give me more flexibility in my eating habits. At the time my HbA1c’s were only just above the "non-diabetic" range but over the next 14 years they rose to over 10! I suffered all the effects other people have related but the worst for me the "night sweats"; I suffered these for around three years and eventually I was put back to beef insulin, my choice. Gradually my old self re-emerged and life was fun again.

After another three years things began to go wrong again; my HbA1cs were still high and we (my consultant and me) decided to try pork insulin. This was OK but the HbA1cs still did not come down - perhaps after so long on human insulin I was subconsciously afraid to have my blood sugars too low! On two occasions whilst playing golf I started to sweat profusely but "knew" it couldn't be low blood sugars. The second time I went to see my doctor and sure enough it wasn't low blood sugar so I was quickly admitted to hospital. Two days later I went to see my Diabetic Specialist Nurse and I have to say she's an angel. We discussed all the facts and she thought that after all the years of being on insulin the problems were arising from different absorption rates on different days possibly due to different physical activities. She suggested Lantus may be a solution, again we discussed it, I agreed and she sought approval from my GP.

Only 2 or 3 weeks later, I received your September Newsletter in which I think you said "lets wait and see". I thought "She's being sceptical again but perhaps she's right to be based on all that we've seen before". Now I have received your latest edition and I am disappointed that you have received no patient feedback on Lantus - disappointed because I feel strongly that I have to say something in Lantus' defence and I don't do things like this!

My DSN said that the Lantus dose would be right when the blood sugar level is the same in the morning as when I go to bed and have the injection. Spot on! If the level is low in the morning the dose is too high. Yes, its not always the same but there are usually very good reasons if you analyse the previous days pattern of carbohydrate intake (particularly late intake of long lasting sugars), and after 54 years I am an inveterate carbohydrate counter! In fact my dose is exactly as the manufacturers suggest (.3 units per kg of body weight). Of course one has to take Humalog as well which can be a problem but fortunately for me, it is a not a life-threatening problem and I can put aside my GM principles if it's in my best interest and in this instance after only three full months of Lantus we seem to have made the right decision for me at least. My blood sugar levels for the last month have averaged 8.9 which probably translates to HbA1c of around 7 which, for me, is excellent.

To address your other concerns with Lantus:

Compared to 35 units of Isophane I now have 23 units of Lantus - a clear reduction in cost to the NHS. Because my monthly requirement for Lantus is around 650 units, 10ml vials of injection are a waste and I use the 3ml vials and a syringe.

You can't confuse a syringe with a 3ml pen so it doesn't matter whether it’s clear or cloudy.

If one has an "early morning hypo" the Lantus dose is too high; it really does do as its said to do - deliver a constant background level of insulin. I'm sorry to sound like a pusher for Lantus but for me it really is as good as the introduction of sliced bread:

My carb intake is as free for me as for anyone who is not diabetic. With Humalog, as you know, you can adjust after eating so I can have a small injection before going out (one that I know will not make me hypo if I don't eat) and adjust later. I don't have to worry about the "delivery profile" of the long lasting insulin - its flat and if I don't eat it doesn't matter – the sky doesn't fall in!

And finally, on the subject of balance (sorry!), I have found that whilst one unit of insulin "neutralises" 10 grams of carbohydrate, an imbalance of 1mmol/l can send blood sugars up or down by 2mmols/l. Determining this (and I couldn't prove it before Lantus) helps me to target my next test with a high level of certainty.

I hope this "post marketing research" is of some use to you.

Mr T.D.

Worcs

PS Lantus is supposed to be injected in the buttock, have you tried this with a 3ml pen? Perhaps not, but that's why I use the syringe!

Dear Jenny,

After the first time I spoke to you, I was very grateful for the Information Pack you sent. You mentioned about animal insulin, so I went to my diabetic doctor and asked for animal insulin but like a lot of people he put me on the new insulin, Lantus.

I have been on Lantus now for 4 months and honestly do not like it at all. My blood sugars seem to be very high, I feel tired a lot and although it has stopped me from going unconscious at night, I am still not happy with it. I have also found that my moods are very bad and I seem to take a lot of things out on my kids for no reason at all.

So I have been reading your latest Newsletter and I have decided that I am going to demand that my doctor puts me on animal insulin as I have now done what he asked and tried Lantus.

I can’t thank you and your team enough, Jenny for all your information because I didn’t even know that ‘human’ insulin wasn’t from humans or that animal insulin is available and I had a choice.

S.P.

N Ireland

People with heart disease are often worried that having sex could be dangerous. A case control study [ref1] has been carried out in Sweden involving 699 people who had all had non-fatal heart attacks. Soon after recovering, they were interviewed about any symptoms and circumstances during the four days before their heart attack, including sexual activity and the frequency and timing of sex. Their physical fitness was also checked.

The aim of the study was to try to find out if sexual activity is a trigger of heart attack and to see whether physical fitness can reduce the chances of this. They found that the overall risk of heart attack was doubled during the first hour after sexual activity but in people with an inactive life, this was increased more than fourfold. However, the researchers concluded that although sexual activity can trigger a heart attack, the risk is very low and lowest in people that are physically fit. They did NOT advocate that doctors should encourage heart patients to abstain from sex!

Ref 1 Heart 2001;86:387-90

The prostate is a walnut-sized gland underneath the bladder in men that encircles the urethra [the tube that carries urine out of the body]. In adults the prostate often begins a new growth and if this is not cancerous it is called benign prostatic hyperplasia or BPH. The pressure of the enlarged prostate may partially close it causing various urinary problems, especially in older men.

A study published in the Journal of Urology, June 2000, shows that in men with diabetes the symptoms of BPH are worse than in men without diabetes. The research looked at the records of 1,290 men with diabetes and 8,566 men without diabetes all of whom were having drug treatment for BPH. They compared BPH symptoms before and after drug treatment and found that men with diabetes had more symptoms and slower urine flow rate that men without diabetes

If an enlargement of the prostate is found then tests have to be carried out to establish it is BPH or localised prostate cancer but to date no tests have been found to be entirely reliable.

• Prostate cancer is slow growing so most men will die of something else before the cancer becomes a problem.
• It seems to occur in almost all men as they get older but is not life threatening and remains localised in the prostate gland. Autopies have shown that 40% of men over the age of 50 have prostate cancer [and never knew] and the risk rises steadily with age so that by the age of 80, 70% of men have it.
• Surveys show that for the average 50year old man with a reasonable life expectancy of a further 25years, there is a 10% chance that he will develop clinically significant prostate cancer but only a 3% chance that he will die of it.

• A weak or interupted urine flow
• Frequent urination during the night
• Burning or painful urination
• Urgent need to urinate
• Urine leakage
• Feeling that the bladder is not empty even after urinating

• Limit the amount of fluids before bed.
• Drink less alcohol and caffeine
• Completely empty your bladder
• Check with your GP that any other medicines you are taking are not aggravating the problems

Consult your doctor - it may be that if the symptoms don’t cause any problems, then there may be no need for treatment other than regular check ups.

Drug treatment – there are two different kinds of tablets that can help, all with side effects. One type of drug relaxes the prostrate muscles and lets the urine flow more easily and the other shrinks the prostate over several months.

Radiotherapy – treatment is applied externally by X0rays or internally by using radioactive implants but a recent study has shown that it has limited efficacy [Int Joun of Radiat Oncol Bio Phys 2002, 53]. It also causes a range of unpleasant side effects.

Surgery – this is often recommended for men with serious BPH problems and prostate cancer. Surgery can have both severe and debilitating side effects that can include incontinence and impotence with a risk that both BPH and prostate cancer can return. A statement from the US National Cancer Institute in July 2001 says that the rate of recurrence rises to 40% 10 years after surgery and a Lancet review [Lancet 1997;349 906-10] says ‘the optimal treatment for localised prostate cancer is still not known.’

Doing nothing does not sound like a treatment option but it is and it may be the best option and one that certainly should be discussed with your doctor. If BPH or prostate cancer is not causing effects or symptoms that markedly affect quality of life, then doing nothing may be the right choice. All the above treatments cause side effects that may be worse than the symptoms. Research is far from conclusive and as recently as 2000 the US National Cancer Institute stated ‘It is not known if the benefits of prostate cancer screening outweigh the risks, if surgery is a better option than radiation or if treatment is better than no treatment’.

CP announced that from March 1^st 2003 3ml cartridges will be available for all their Hypurin Porcine and Hypurin Bovine insulin products that currently have a 1.5ml cartridge. The 1.5ml cartridge will be phased out by September 2004, giving 18months to allow people to change over the 3ml cartridge and pen. This will make a wider choice of pens available to users of animal insulin. The new 3ml cartridges are compatible with the Owen Mumford 3ml Autopen range, excluding Autopen 24.

Included are the longer acting beef insulins – Hypurin Bovine Lente and Hypurin Bovine PZI. As many people are prescribed Lantus, the new 24 hour synthetic GM insulin, it is important to know that 24 hour natural animal insulin is also available.

• Multiple dose insulin [MDI] therapy has failed, including the use of insulin glargine [Lantus].
• Those receiving the therapy are willing and able to use the therapy effectively.
• Insulin pump therapy should be provided by a trained specialist team [physician specialising in pump therapy, diabetes nurse and dietician].
• People beginning pump therapy should be provided with training in its use and ongoing support.
• These recommendations for Type 1 diabetes are also valid for children, adolescents, pregnant women and women who are intending to become pregnant. However, because of the risk to the fetus, pregnant women and those intending to become pregnant should only switch to insulin pump therapy under the care of a specialist team.
• Established users of pump therapy should have their insulin management reviewed as they may be suitable for a trial of insulin glargine [Lantus], a long-acting insulin like medication.
• Pump therapy is not recommended for people with Type 2 diabetes who require insulin.

NICE considers that insulin therapy has failed when someone has been carefully trying to manage their diabetes but has been unable to keep their blood glucose levels within recommended levels resulting in ‘disabling hypoglycaemia’, which make them anxious about the episodes reoccurring and significantly spoiling their quality of life. Disabling hypos are defined as repeated and unpredictable hypoglycaemic episodes that require help from other people.

The estimated cost of switching all potentially eligible people to insulin pump therapy is around £3.5million per year. This is based on 1-2% [2000 to 4000] of people with Type 1 diabetes moving to pump therapy.

NICE [National Institute of Clinical Excellence] is part of the NHS but is an independent organisation responsible for providing national guidance on treatment and care in the NHS in England and Wales for health professionals, patients and their carers. In January 2002 it became a statutory obligation for the NHS to provide funding for treatments and drugs recommended by NICE but only if considered appropriate by the doctor and the patient. So NHS organisations locally have to make resources available within 3 months to enable NICE recommendations to be implemented.

Once NICE guidance is published healthcare professionals are expected to take it fully into account when exercising their clinical judgement. But NICE guidance does not override the individual responsibility of health professionals to make decisions appropriate to the circumstances of the patient in consultation with them and/or their guardian or carer.

Late News – The NICE guidance on pump therapy has been accepted by Scotland.

• It is often thought of as an economy class syndrome – it isn’t as it has also occurred in first and business class passengers.

• DVT can be caused by travelling at 33,000 feet in the air, it can also be caused by sitting for long periods in cars, buses, lorries and trains.

• Certain forms of cardiac disease
• Abnormalities in blood clotting
• Pregnancy
• Recent major surgery or injury
• Recent immobilisation for a day or more.

In addition to these factors, recent research has shown that there may be additional risks from smoking, obesity and varicose veins.

• Drink adequate amounts of fluids, especially water
• Avoid drinks that contain alcohol and caffeine
• Avoid smoking
• Avoid sitting cross legged
• Walk around in the cabin whenever you can
• Stand up and stretch your arms and legs periodically
• Wear loose fitting clothes when travelling.

The main cause of jet lag is crossing time zones and a lot of research shows that it is worse going from west to east than from east to west but people vary and are affected differently.

• Try to keep calm before the journey as excitement, stress and nervousness can make it worse
• Have a good night’s sleep before the journey
• Try not to eat too much on the flight

• Avoid alcohol, tea and coffee
• Drink plenty of water because the body is susceptible to de-hydration on long flight

Thank you to all the people that responded to this column in the January 2003 edition of the Newsletter. It is an opportunity for people with specific questions to ask readers if they have similar experiences and if so, have they found any specific treatment or information that has helped. Here are some more:

• Several people have exercised their rights to look at their hospital and/or GP medical notes but found this experience made them upset and angry. Some found that their notes had been slimmed down and there were inaccuracies eg being classed as a ‘new diabetic’ when in fact the person was diagnosed over 30 years ago! They felt that the language was upsetting, describing it as patronising, almost hostile, legalistic. When they reported their problems they were noted as ‘He/she claims that…’ as if it wasn’t actually true! All these people had previously raised questions about their treatment options and insisted on using animal insulin. They wonder if this is why the notes are written in this way or is this just the way that all medical notes are written and would like to hear from anyone else who has seen their medical notes.

• A young lady of 19 that has had Type 1 diabetes for 8 years. Over the last 18months she has suffered from vomiting and stomach pains that have gradually worsened. She has tried changing her insulin types but this has had no effect. Her doctor are puzzled and are putting it down to an eating disorder. Have any readers had similar experiences and has anything helped.

In February 2003 Lilly introduced a new drug, Cialis, for the treatment of impotence. Its effects last for 24 hours and so the manufacturers say that it will allow men to choose when they want to have sex and will allow couples greater spontaneity. Like Viagra, it will only be available on the NHS to certain patients.

The publicity says that in clinical trials Cialis worked in up to four out of five men with erectile dysfunction.

• Americans spend more than £68billion on fast foods each year with almost one in four adults visiting a fast food restaurant on any given day.

• Last year a teenage boy with Type 2 diabetes in the US attempted to sue McDonalds for not providing the necessary information about the health risks associated with its food. But in January 2003, the judge dismissed the case because the plaintiffs failed to show that customers were unaware that eating too many McDonald’s could be unhealthy and the law does not protect people against their own indulgence. Worth noting that the boy ate McDonald’s 3 or 4 times a week! This decision came on the day McDonalds announced a deficit of £212million for the last 3 months of 2002.