INSULIN DEPENDENT DIABETES TRUST

July 2006 NEWSLETTER

WHY ARE PEOPLE SO PASSIONATE ABOUT ANIMAL INSULIN?

The answer is simple - they are passionate about having a future. For people who have experienced the adverse effects of synthetic insulins, and for their relatives, this is not a dramatic, emotional response but one that is based on their experiences.

As the editor of this Newsletter, I freely admit to being passionate about animal insulin. At the age of only 18 my daughter was very ill and deteriorated to the stage that she could hardly walk but within days of changing to animal insulin, she improved beyond belief and has had 17 health and happy years using animal insulin. As a mother, I expected to worry about her future and the risks of long term complications but in a developed country with a health system, I did not expect to have to worry about the possibility of the insulin she needs not being available to her. We share these experiences with many other people and yes, we are entitled to be passionate about animal insulin, it holds the key to a healthy life for so many people. 

The looming discontinuation of pork insulin by Novo Nordisk has raised emotions amongst people - fear for their future and anger because their health is being put in jeopardy by 'rationalisation of a product range', or put more simply, by the desire of pharmaceutical companies for even greater profits.

We understand that the general public believes that insulin is insulin per se, but surely everyone involved with the treatment of diabetes knows that insulins are different, people are different and what suits one will not necessarily suit another, or do they? That the question in the title is being asked at all shows a lack of understanding of people with diabetes and indeed, of diabetes itself. 'Why are people so passionate about animal insulin?' The answer to this lies in a letter received a few weeks ago from an IDDT member:

'I have been diabetic since the age of six; I am now forty five years old. I was always healthy and fit until the early 90s when I began feeling lethargic and generally run-down. I now know this was due to a change of insulin - from pork to synthetic with no reason and without my knowledge or consent.

At first there seemed to be no difference, but over time, the side effects became increasingly worse and over a number of years built up to include the following symptoms:

Loss of hypo warnings                              Extreme tiredness

Unstable blood sugars                              Non-stop bad dreams

Fits with hypos                                          Paranoia

Extreme fatigue                                        Mood swings

Aching bones [similar to arthritis]              Muscle cramps

Panic attacks                                            Depression

Hair loss / poor hair condition                   Generally unwell

Extreme perspiration

In 2001, when at death's door, I insisted on being put back on pork insulin because everything the doctors and diabetes nurses had attempted to relieve the side effects had failed [apart from changing the one thing it had to be]. Within three days, every side effect had reduced to such a level that I felt like a new person. Within a three-month period, I was 100% improved, although I have never regained my hypo  warning signs, a condition that I attribute wholly to the long-term use of synthetic insulin.

I have received your Newsletters since 2001 and compliment you on your professional and accurate portrayal of information. I also think it is important that you are not funded in anyway by the very pharmaceutical company that is ceasing production of a valid and proven insulin that some of us need. So I thank you once again for a life-changing Newsletter.'

EVEN TIGHTER TARGETS FOR DIABETES CONTROL - CAN WE DO IT?

A report by the Joint British Societies, 'Guidelines on the Prevention of Cardiovascular disease in Clinical Practice' was published in December 2005 and sets even tighter targets for people with diabetes [and the general population].

The targets are as follows:

·         pre-prandial [before a meal] blood glucose levels of 4-6mmols/l

·         HbA1cs of 6.5% or below. [long-term test showing average blood sugars over lat 6-8 weeks]

·         blood pressure target - 130/80mmHG

·         total blood cholesterol target - less than 4.00mm/l or a 25% reduction; LDL cholesterol [the bad stuff] lower than 2.00mmol/l or a 30% reduction

Looking at these targets, one wonders how many patients were present when they were made and if those setting these targets look at any other aspects of living with diabetes, in other words 'real life'.

Raising the targets raises a whole load of questions and practical issues for people who actually have diabetes. Here's a few:

·         What extra help and support is going to be given to people to help them to try to achieve them? Are there going to be more frequent clinic visits? We have known since 1991 and the Diabetes Complications and Control Trial [DCCT] that tight control reduces the risk of complications, but the follow up study also showed that once the study had finished, people could not maintain the same level of tight control. So simply raising targets without the extra help needed to achieve them, may not be effective for many people.

·         What about the trebling of the increased risks of severe hypos that we know occurs with tight control if the targets are 4-6mmols/l and HbA1cs of 6.5%? [Again results from DCCT 1991] Tight control increases the risks of hypo risks per se, so what about the increased risks of loss of hypo warnings, a cause of which can be frequent hypos?

·         What about driving with a pre-meal blood glucose level of 4? With the known inaccuracies of meters, a level of 4 could actually be less than 3.9 which is hypoglycaemia and is known to impair judgements, could cause traffic accidents and ultimately loss of driving licence and loss of job.

Diabetes UK 'welcomes the challenging targets because more than 25,000 people with diabetes die from cardiovascular disease every year' and states that 'though not everyone will achieve the targets straight off, any progress towards them will help reduce the risks.' [Diabetes Update, Spring 2006] This is undoubtedly true and the medical thinking is understandable - to help people reduce the risk of long-term complications. However, people with diabetes may have a different perspective and a different set of priorities that are more to do with the quality of their everyday life and that of their families. It is all about choice, so set the standards but at the same time understand that people may have other priorities and should not be made to feel failures for not achieving the targets.

The avoidance of complications is vital and no one would dispute this but to people with diabetes, the quality of life is also important.

Frequent hypos and/or hypos that require the assistance of partners or parents, reduce the quality of life for everyone. It is well recognised that people avoid hypoglycaemia by keeping their blood sugars a bit higher than recommended, but this gives rise to conflicts - do I do what the doctor says and achieve the targets or do I run the risk of hypos at work etc. 

For some people constantly trying to achieve targets by increased blood glucose testing, increased injections and increased numbers of medications is seen as a reduction in their quality of life. All this and then perhaps failing to achieve the targets can give rise to a hold load of other emotions - feelings of failure, of low self-esteem, depression and wanting to give up altogether.

Setting higher targets places additional pressures upon both people with diabetes and their families.

An article by Marie Clark [Pract Diab Int, March 2006 Vol 23 No.2] says of more intensified treatment and increased self-management that the advances in medicine have increased the demands on the individual. How well those living with diabetes are able to self-manage diabetes depends on many factors and there is increasing evidence that emotional and psychological well-being play a major role in this. This is why the National Service Framework [NSF] for Diabetes includes a section 'Empowering People with Diabetes' which recommends that psychological support is part of the treatment for diabetes. Marie Clark's article says that 'psychological and emotional well-being is the foundation upon which all other aspects of the treatment regimen should rest.'

So if targets are to be tighter, greater help and support is needed for people to achieve them or to help people cope with not achieving them!

DISPELLING THE MYTHS

My diabetes nurse has told me that I can't use pork insulin because I am on such large doses of 'human' insulin, is this true? NO and in fact quite a lot of people find that they need less insulin when they change to pork insulin.

My diabetes specialist nurse has told me that pork insulin is not available in cartridges for use with a pen, is this true? NO, Wockhardt supplies pork insulins in both vials and cartridges.

My diabetes nurse has told me that I can't use pork insulin because I am not insulin dependent but have Type 2 diabetes so have to be treated with 'human' insulin, is this true? Insulin dependent diabetes was the commonly used name for what is now called Type 1 diabetes. However, whether or not you have Type 1 or Type 2 diabetes treated with insulin, you can still use pork or beef insulin.

NORTHWICK PARK - NEW RULES ON DRUG TRIALS

April 6^th 2006 - the interim report on the drug trials at Northwick Park hospital that resulted in 6 men being in intensive care, found no evidence of human error, contamination or failure to follow protocols but stricter rules are to be introduced for drug tests on people. The report suggested that the drug TGN1412 caused an unprecedented and unexpected reaction that did not occur in tests on animals. Medicines and Healthcare products Regulatory Agency (MHRA) chief executive, Kent Woods, said that future trial applications for biological agents would be subject to new levels of scrutiny:

·         such agents will now be seen by the Commission on Human Medicines as well as the MHRA, with further external experts brought in ad hoc should any doubts remain.

·         a working group is also being set up by the government to examine the transition from animal to human testing involving biological agents with novel actions.

Professor Woods said that the interim report raised questions about the potential risk involved in human trials, particularly the new class of drugs which work by stimulating action affecting cells in the immune system. He also said that this is a complex scientific issue which raises important scientific and medical questions about the potential risks associated with this type of drug and how to make the transition from pre-clinical testing to trials in humans.

Call for independent inquiry

There are calls for an independent inquiry, as it is being suggested that the Health Select Committee Report on the influence of the pharmaceutical industry [April 2005] casts doubt on the MHRA's suitability to carry out an investigation. The Committee's report said 'The organisation, process and techniques of the MHRA are focused on bringing drugs to the market fast. The organisation has been too close to industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We recommend that more research be undertaken into the adverse effects of drugs, both during drug development and medicines licensing.' So maybe in independent inquiry is the correct way forward.

The rush to licence drugs

One of the delays in bringing new drugs to the market is that many companies were already struggling to find people prepared to enter trials. A recent report published by market intelligence firm Cutting Edge Information showed that 30% of clinical trial time is spent finding and enrolling study participants - the cause of almost half of all trial delays. In many cases trials are being delayed by over six months costing drug companies over half a million dollars in lost sales for specialty products and more than $8m (?6.7m) for blockbuster brands.

Pressure on people to take part in trials

It is important that new drugs [and new insulins] are developed but this is almost bound to involve trials in people. The first trials take place in healthy men [men because they are not likely to be pregnant!] and then in people with the disease/condition for whom the drug is designed.

Taking part in trials is or should be entirely voluntary but some people feel obliged to take part especially if their doctor is running the trials - they want to please their doctor or they feel pressurised to do so. Other people want to take part in trials, especially if there is a 50/50 chance that the new treatment may be better and in the case of trials related to diabetes, the care received is usually significantly better than 'normal care'.

So before agreeing to participate in a trial here are a few things to think about:

·         It is important to know that the effects of older chemical drugs are likely to be more predictable than with the newer biotech drugs and so the risks with them are greater.

·         Do not feel you have to take part in trials because your doctor or clinic has asked you

·         Take the details of the trial home with you and read them carefully and see what is involved

·         Always ask questions about anything you don't understand

·         Ask if the trial is to be published as it is important that your effort in participating in the trial forms part of the evidence on which the drug/treatment can be judged

·         Ask if the trial is being sponsored by a pharmaceutical company or is an independent study as this may affect your decision

·         If you decide to enter the trial, you should be given a consent form, and again read carefully and if there is anything you don't understand, ask the questions

·         Do not be rushed into a decision, take your time.

Changes to improve improve the safety of drugs

March 28^th - the Dept of Trade and Industry [DTI] has set up an £8million fund to stimulate research into safety biomarkers. Biomarkers are an emerging science which will help assess and predict toxicology and adverse side effects of potential medicines in pre-clinical research. The use of these techniques will help drug companies identify compounds for elimination at an earlier stage which is expected to save costs on research, speed up medicine development and contribute to a reduction in animal research. In the long-tem it is also expected to contribute to patient safety.

May 22^nd - in the wake of Northwick Park, the World Health Organisation is calling for greater transparency in clinical trials by announcing new registration standards for all medical research involving humans.

JUST TO REMIND YOU??

·         Date for your diary - IDDT's Annual Conference entitled 'Make your Voice Count' is on October 14^th 2006 at the Paragon Hotel in Birmingham. Please do come and join us - the programme and further details are available by contacting Bev Freeman at IDDT on 01604 622837, e-mail enquiries@international.org or write to IDDT, PO Box 294, Northampton NN1 4XS

·         If you are a parent of a child or teenager with diabetes - in May 2006 IDDT published it's first Parents Bulletin, If you would to receive this and future copies, just get in touch with Bev as above.

IDDT GOES TO WESTMINSTER

Report from Jenny Hirst

Thanks to you - our members

I would like to thank all our members who have written to their MPs about the discontinuation of Novo Nordisk pork insulin and the supply problems there have been with Wockhardt's animal insulins. The key points that you have made are the vulnerability of people who need pork insulin when the UK is left with only one supplier and the misinformation that is being given by health professionals about future availability. Your letters have supported us when meeting MPs and asking them to table Parliamentary Questions and of course, they have resulted in the Minister of Health and the Dept of Health being made well aware of our concerns!

Working with our advisers, the following has been achieved:

·         The Earl Howe and John Baron MP had a meeting with the Minister, Jane Kennedy MP to put our concerns to her.

·         A meeting with the officials from the Dept of Health, Novo Nordisk [NN], Wockhardt, Diabetes UK and the JDRF to discuss the confusion amongst healthcare professionals and patients about the Novo Nordisk discontinuation of pork insulins, made worse by the misinformation about temporary shortages of Wockhardt insulins. It was agreed that all steps possible will be taken to ensure that everyone using NN pork insulin would be informed that they can continue to use pork insulin from Wockhardt including a warning seal on every NN pork insulin pack and letters to GPs. Wockhardt is building up their stocks to take into account the increased demand from the NN withdrawal and to have 3-6 months contingency stocks.

·         Over 30 Parliamentary Questions have been asked along with follow up Questions to the Minister's response, if appropriate.

The aim of the Parliamentary Questions is:

Secure supplies - to ensure that supplies of animal insulins are secure when there is only one supplier and to encourage the Dept of Health to have back up supplies in place.

NICE appraisal of all insulins - asking the Minister to refer all insulins to the National Institute of Clinical Excellence [NICE] for an appraisal of their clinical effectiveness and their cost effectiveness. As diabetes affects so many people and  is such a high cost to the NHS it seems only reasonable that NICE should do this, as it does for many other drugs but it is particularly important because [i] choice is being reduced by the Novo Nordisk discontinuation of pork insulins and some human insulins so we need an assessment of the all the alternatives [ii] there are concerns about the long-term safety of analogue insulins [iii] Canada has not approved Lantus for funding and Germany has not approved NovoRapid for funding for Type 2 diabetes, so surely NICE should carry out an appraisal of all insulins in the UK.

Adverse reaction reports - the information on these on the Yellow Card Reports available to the public has not been updated since it was first available in January 2004. With the increasingly widespread use of analogue insulins with only scant evidence of benefit for some people, it is important that patients have access to up-to-date information on suspected adverse effects to enable them to make informed treatment choices. As IDDT has received a lot of complaints about long-acting insulins and Lantus in particular, the Minister was asked how many adverse reaction reports there have been and how many deaths. The answer is: "A total of 373 reports of suspected ADRs have been received in association with insulin glargine [Lantus] since January 2002 and of these 15 had a fatal outcome. Where cause of death was reported there is no particular pattern."

NOTE WELL - The reporting of a suspected adverse reaction does not necessarily mean it was caused by the drug as it may relate to other factors such as underlying illness or other medicines taken concurrently. It is not valid to compare the number of reports of suspected adverse reactions between products as a number of different factors affect the level of reporting of adverse reactions including the level of usage of the product, how long the product has been on the market and any publicity surrounding the product.

Future actions - again I would like to thank all our members and their Members of Parliament for their support. I assure you all that we will continue to do all that we can to make sure that animal insulin users are not forgotten and that all insulins are demonstrated to be safe and effective.

PHARMACEUTICAL INDUSTRY NEWS

New Code of practice for industry - in January 2006 the Association of the British Pharmaceutical Industry [ABPI] introduced a tighter Code of Practice to govern relationships between the pharmaceutical industry, health professionals and patient/carer groups ie acceptance of gifts etc or in the case of charities, funds. A survey by the ABPI showed that only 52% of all doctors are aware of the ABPI Code of Practice with 65% of GPs being aware compared to only 40% of hospital doctors.

Damages awarded in the latest Vioxx lawsuit - law suits have followed the withdrawal of arthritis drug Vioxx by manufacturers Merck, on evidence that it increased heart problems. A recent case in the US awarded $13.5million of damages when the jurors concluded that Merck delayed notifying patients of the risks once they were aware of the drug's dangers. This case was the first to involve people who used the drug for more than 18months and is important because the study that resulted in the withdrawal of Vioxx found that its risk doubled after 18months' use. Merck faces 10,000 Vioxx related lawsuits in the US.

A new drug to treat neuropathic pain - Lyrica made by Pfizer. The doctor who ran pre-marketing trials has said that it provided rapid and sustained pain relief among the participants. However, the common adverse effects are dizziness, sleepiness, dry mouth, swelling of hands and feet, blurred vision, weight gain and trouble concentrating. Finally patients with a history of drug or alcohol abuse may have a higher chance of misuse or abuse of Lyrica. It is available on an NHS prescription.

SHOPPING AROUND FOR DOCTORS!

Thanks to the actions of the pharmaceutical industry, in most countries there are NO animal insulins but most countries do have a system for personal importation of drugs that are not licensed in their own country. This is the case in the US so in theory people who cannot tolerate human and analogues insulins, should be able to  import beef or pork insulin from the UK for their personal use. But this is proving difficult and in some cases, impossible. The reason? Doctors are refusing to write the necessary letter for importation which has to say [i] animal insulin is medically necessary and not available in the US and [ii] that he/she will report any adverse reactions.

Not too difficult one would think but many doctors are not prepared to prescribe animal insulins as they are classing them as 'unapproved drugs' when pork insulin was approved and available until just a few weeks ago! This is illogical nonsense that is harming people with diabetes and causing great distress:

Nonsense - before their discontinuation, both beef and pork insulins were available over-the-counter [no prescription needed at all], and this was classed as safe.

Nonsense - doctors won't prescribe animal insulins that have been used safely for many years and yet they are happy to prescribe new insulin analogues where the long-term safety is unknown!

Nonsense - the reason for the refusal to write the letter could be doctors' fear of litigation, perhaps understandable in the US, but don't they fear litigation if harm comes to their patient as a result of adverse effects from using synthetic insulins because they have refused to supply animal insulin?

What's the answer? IDDT receives desperate calls, letters and e-mails from people in the US who need animal insulin and the only answer we have is to advise them to shop around for a doctor who understands the needs and indeed, understands the first ethical principle of medicine - first do not harm.

CANADA - Wockhardt pork insulin is there, but??..

For our Canadian members, the good news is that following Lilly's discontinuation of Iletin ll [pork] insulins in April 2006, Wockhardt Hypurin porcine insulins are now available in vials. The details are:

·         Hypurin NPH Insulin, Pork [DIN 02275864] - short-acting

·         Hypurin Regular Insulin, Pork [DIN 02275872] - intermediate-acting

Your pharmacist can access this insulin by contacting:

Nucro-Technics, Tel: 416 438 6727 Fax: 416 438 3463 or info@nucro-technics.com

At the time of writing, Wockhardt is applying to the provinces to have this insulin included in their formularies which is required for patients' costs to be covered. 

However, the bad news is that the cost is just under $100 per vial [£50] which gives it the very dubious honour being about the most expensive in the world! One of the major concerns is that at this price, will the provinces fund it? Even if they do, under the Canadian health system the cost is not covered for everyone. So for people requiring 4 vials a month, the cost could be $400 dollars = £200 a month! No matter how much people need pork insulin, for some, it will simply be unaffordable.

It was actually slightly cheaper to import directly from the UK but this option is now no longer open because Wockhardt pork insulin now has a licence in Canada. Needless to say, people in Canada feel very let down - the promise that they would not be denied the pork insulin they need but when it arrives, it is at a price that is unaffordable for many people. IDDT-Canada and the Society for Diabetic Rights are working together to try to help this unfair situation.

WHAT'S NEW

·         Autopen Special and the Autopen Junior discontinued - from June 1^st only the Autopen Classic will be available from Owen Mumford. This is now the only pen available for users of pork and beef insulins. It is a pity that they have not kept the Autopen Junior because the colours of the markings, black on yellow, are easier to see for people who are visually impaired.

·         Updated version of the needle free injector, mhi-500 - called the SQ pen, still made by the Medical House and available on prescription. There has been a medical device alert issued to warn people using the mhi-500 devices made before June 2005 - it could break and become unsafe either when it is dismantled to add or remove the comfort rings or if it is fired without insulin in the nozzle. New instructions have been issued by the manufacturers and are also being given out with the purchase of mhi-500 consumables. The mhi-500 devices made after June 2005 have the comfort rings fitted by the manufacturers and therefore do not need to be dismantled. Further help can be obtained from the Medical House on 0800 917 7326.

·         New blood glucose meters - Glucomen Visio by Menarini Diagnostics which doesn't need calibrating and has an adjustable lancing device to reduce the pain. Then there is another new meter from Roche, Accu-Chek Compact plus, which is a combination device of meter, test strips on a drum and detachable finger pricker so theoretically tests could be done with one hand. More details are available from Roche's website www.accu-chek.co.uk

INHALED INSULIN - WE CAN'T AVOID TALKING ABOUT IT!

The interim recommendation from the National Institute for Clinical Excellence [NICE] that inhaled insulin, Exubera, is not funded by the NHS has caused quite a fuss, hitting headlines in the newspapers. It was even raised in Prime Minister's Question Time when the Chairman of the All Party Diabetes Group asked the Prime Minister to look again at the NICE decision and on this occasion, Tony Blair's answer seemed sensible. While agreeing to pass the remarks to NICE, he said: 'It is important to remember that that body ends up making clinical decisions. I am not qualified to do that and neither is he.'

The Times made political mischief on their front page by linking the NICE decision to shortages of funds within the NHS. Sadly in the Letters column the next day, an angry father wrote to ask members of NICE if they had tried chasing a 4year old around struggling to inject him. While sympathies are with the father, it is sad because he has been so misled by all the hype about inhaled insulin - no trials have taken place in children and Exubera was NOT licensed for use in children. For months newspapers have raised people's hopes for inhaled insulin, no doubt fuelled by press releases from manufacturers but the newspapers gave a very one-sided story in making their claims that inhaled insulin is the greatest breakthrough since insulin was discovered. But is it?

It could lead to better and more reliable alternatives to injections, so in this sense it is a great breakthrough but we should not lose sight of other great breakthroughs that have had a truly dramatic effect on the lives of people with diabetes. The development of long-acting insulins in the 1940s made a huge difference - can you imagine life without them? Home blood glucose monitoring was probably the greatest breakthrough since 1922 - it has resulted in better diabetes control and knowing what their blood sugars are at any given time provides people with a better quality of life. Can similar claims be made for inhaled insulin? Based on the evidence so far, the simple answer is, no.

Let us look at some facts:

1.    Inhaled insulin is licensed for use in adults only, not children. The trials have been carried out in adults with Type 1 and Type 2 diabetes but no benefits in diabetic control have been shown.

2.    Injections of long-acting insulin are still necessary so people who are needle phobic will still have to inject. Trials have only been carried out with 'human' insulin as the long-acting insulin and NOT with analogue insulins which are now widely prescribed, so again the safety is unknown if Lantus or Levemir are used. 

3.    The long-term safety is unknown with concerns about possible lung damage and the effects on the development of insulin antibodies. It is not suitable for people with underlying lung disease, those with asthma or smokers.

4.    The amount to be inhaled is in 3 units, so people who make small dose adjustments of 1 or 2units will not be able to do so with Exubera.

5.    The inhaler is not small like an asthma inhaler, but opens up to about 9 or 10inches, there are 5 steps to prime it. There is no way that it could be used discreetly in public, as is the case with injections! Women would need a fair sized handbag to carry it around and men could not fit it into a jacket pocket as they do with pens or syringes.

So what are the benefits?

The benefits appear to be patient preference and quality of life, but NICE considered the information on this was insufficient. Some of the evidence on quality of life was gathered from people with Type 2 diabetes who don't use insulin, so could they make a fair comparison between inhaling and injecting insulin?

It is argued that people with Type 2 diabetes are put off going on to insulin because they have to inject and if inhaled insulin was available to them, they would start insulin treatment sooner, so reducing the risk of complications. The logic of this argument does not stack up as they would still have to inject long-acting insulin. There is also evidence that one of the reasons people are put off going on to insulin treatment is that they think this means their diabetes has got worse - this would still apply if they used inhaled insulin. So the evidence suggests that the people who could benefit would be those with Type 2 diabetes who have yet to go on insulin.

Then there is the cost!

It will cost an extra £500 per patient per year. NICE made this interim decision by looking at inhaled insulin on its own merits. We should do this too but we can also look at it on a broader level - at a time when people are being refused essential blood glucose testing strips to save NHS money, should NHS money be spent on inhaled insulin when the evidence shows little benefit and unknown long-term safety?

Note: The NICE recommendation is only interim and the final decision will be made later this year. On May 15^th Pfizer told Pharma Technologist.com that they vow to fight the decision and are confident of having it overturned in light of �new evidence.� We shall see????

May 4^th 2006, Germany takes a similar stance - the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany has published a report showing that there is no additional therapeutic benefits to replacing insulin injections with inhaled insulin; no evidence that Exubera shows advantages over injected short-acting human or insulin analogues; no evidence that it would improve the quality of life or treatment satisfaction of diabetes patients in Germany. However, they state that there are indications of disadvantages of Exubera therapy eg an increase in severe hypoglycaemia rates. IQWiG recommends further evaluations and an adequately designed randomised study before Exubera is widely prescribed in Germany.

The significance of Exubera to the pharmaceutical industry - "The groundbreaking approval of Exubera signals that exciting times are ahead for the pulmonary route of drug delivery in many disease areas.' [In-PharmaTechnologist.com 21.4.06] In other words, Exubera approval opens the door for this method to be used for other drugs. So just as human insulin was the first GM drug to be approved and opened the market for all other GM drugs, inhaled insulin is set to do the same for inhaled drugs!

MORE NEWS ON DRIVING

Driving restrictions for people with Type 2 diabetes reassessed

As a result of new research, the Dept of Transport is to consider easing the driving restrictions on people with Type 2 diabetes taking insulin. At present they are banned from holding a Group 2 licence, which includes lorries and buses, because of the risk of hypoglycaemia which can cause blurry vision and delayed reactions.

New government research using self-reported hypoglycaemia and continuous glucose monitoring over 9-12months has shown:

·         people with Type 2 in the early stages of insulin treatment are at no greater risk of hypoglycaemia than people treated with sulphonylureas [tablet treatment that can cause hypos]

·         people with Type 2 in the early stages of insulin treatment may be prone to less severe or less frequent periods of hypoglycaemia compared to people with Type 1 diabetes.

·         once insulin injections are used over a longer period in people with Type 2 diabetes, the rate of hypoglycaemic events begins to increase and by 5 years the risk is similar to that in people with Type 1 diabetes. 

So it appears that some people with Type 2 may be less of a risk on the roads than previously thought. Road Safety Minister Stephen Ladyman has said the government will review the research to check the validity of the findings as there are potentially serious implications for driving licence entitlement. The research will be considered by Medical Advisory Panel on Diabetes and Driving to assess whether any changes to licence restrictions may be necessary. A European Commission medical expert group has been considering the minimum medical standards for diabetes and driving and is due to report shortly. The UK expert group is likely to wait for the results of this investigation before making any recommendation.

Campaign update - the DVLA, driving and visual fields

By Jackie Banks

I am pleased to report that after 7 years of campaigning on behalf of drivers with diabetic retinopathy, I was invited to attend the Dept of Transport Lay Interest Meeting on this subject [1.2.06]. The meeting was also attended by the At Work Partnership: Mr Peter Hamilton, retinopathy consultant: Mr Simon O'Neill, Diabetes UK: four lay members of the Secretary of State's Honorary Advisory Panel [DVLA]: Dr Liz McNeil Grist, independent medical writer and Dr Liliana Read, Dept of Transport.

The purpose of the meeting was to thrash out concerns and misunderstandings being experienced by drivers with retinopathy when they have lost their driving because they have failed to teach the current criteria for visual fields.

One of the concerns has been that testing is carried out on machines we find extremely difficult to use. The reason for this is that following retinal laser treatment you learn to adapt to any field loss by scanning with the eyes [which is required anyway in order to pass a basic driving test] whereas testing equipment requires central fixation of the eyes. The results are therefore known to be misrepresentative of what you actually see. In addition, the test machines have never been tested in controlled trials and were never intended to use for licensing purposes. However, results from them have been viewed by the DVLA as an accurate portrayal of what is seen.

Another concern has been an obvious lack of knowledge of retinopathy on the part of the visual disorders panel, leading to its insistence that retinopathy automatically leads to eventual blindness even after laser treatment, and therefore can never be stable.

These and many other related issues were discussed at length and all relevant points carried forward to the experts' workshop on retinopathy on March 2^nd 2006. Following these meetings, I am now confident that the DVLA is now in full possession of all the medical facts relating to retinopathy. The experts are to meet at 2 yearly intervals, which has to be encouraging.

At the lay meeting, it was recommended that:

·         a fairer approach to testing be adopted by the DVLA with on-road assessment being an option rather than licence removal in cases where field test results are borderline to requirements for as long as current test machines are still in use,

·         if no further laser treatment has been given since the previous renewal, that field testing is unnecessary at renewal once the required criteria are reached.

I am hopeful that all these recommendations will be implemented.

Note: A consensus report agreed by the experts will be published for the public in about 6 months.

DIETITIANS LACK TRAINING IN CARB COUNTING

A report published in Diabetes Update [March 2006] of a survey of dieticians shows that 50% of dieticians feel that they need more training in carbohydrate estimation. One third of dietitians did not consider themselves confident to teach people on insulin about the quantity of carbohydrate in food. Dieticians who have had additional training or are treating patients on insulin pump therapy are more likely to teach carbohydrate estimation to their patients.

Diabetes UK who carried out the survey says: 'There are huge gaps in patient care and dietician�s education and it is crucial that all people with diabetes have equal access to education. At the moment this is clearly not happening and people with diabetes may well be suffering as a result.'

Those of us that have lived with diabetes for many years must find the results of this survey amazing as we were automatically trained in carb counting as part of the standard education package - and by dietitians! Much as we may joke about 10grams of potato being the size of a hen's egg and having little scales to weigh food, it provided us with sound knowledge of carbohydrate values that have stayed with us throughout life. Clearly this has been lost over the years and dietitians have not received the necessary training to treat people with diabetes appropriately.

PLANNING TO LOSE WEIGHT?

By Katharine Morrison - a GP with a son who has Type 1 diabetes

Becoming and keeping slim is of even greater benefit to people who have diabetes than the general population. Abdominal obesity promotes insulin resistance and insulin resistance promotes abdominal obesity. Worsening of blood sugar control and the insidious death of overworked pancreatic beta cells results.

Most people know what to eat and what not to eat to stay thin. They just don�t follow their plan consistently enough says weight loss doctor Stephen Gullo. He asks his patients, �Do you really love this food so much that you want to wear it?�

He has many tips and strategies to help people succeed and these are published in his best selling book, �The Thin Commandments.�

Keeping a written record of all the food you consume is a good starting point. Instead of grazing throughout the day or alternatively delaying and missing meals he recommends planned eating about every four hours. The food of course cannot be any old thing that is around. You must plan ahead. A simple and obvious thing to do, isn�t it?

Yet, many things seem to get in the way of such a straightforward action plan. Emotional eating, food cravings, distractions, huge portions, just plain boredom. Every meal is a weight losing, gaining or maintaining opportunity. You have the choice.

It can be difficult to deal with carbohydrate and other cravings especially if you are sleep deprived or stressed. A high protein or high fibre breakfast can help. Protein shakes are portable and can blunt that sweet tooth. It is much easier not to buy food that you overeat rather than attempt to resist it once it is in your cupboard. High sugar or fructose plus fat seems to be the worst combinations for craving which stimulates fat storage. This combination is widely available in processed and fast foods.

Many people are quite frugal eaters till they get home at night. By then they are starving and then there is no holding back. An afternoon snack around 4 pm can help especially if it is of the filling high protein/high fibre type. Following this with an evening meal with high fibre vegetables, salad, and an adequate amount of protein will keep you going till morning without over doing the calories.

Hunger outside with meal times usually means you have underdone the protein or overdone the rapidly acting carbohydrate at the previous meal. Your daily protein requirement can be worked out by dividing your ideal weight in kilograms by six. If a woman weighs 60kg for instance she will need 10 oz of lean protein a day split between meals and snacks as a minimum. One egg is around one ounce of protein if this makes size estimation more meaningful.

When you shop for food go on a full stomach and don�t buy naughty things for �someone else�. Make a list and stick to it. For many people internet grocery shopping can help. What things do you find difficult to resist?

Apart from not actually buying and eating the stuff what else can you do to take your focus away from food? Social activiies, exercise, self soothing activities and house and garden work are all possibilities. �Why are they so unattractive compared to eating a tube of Pringles in front of the telly?� I can�t help but ask myself.

Dr Gullo insists that your lifelong success at weight control depends on how well you handle the foods that tempt you the most. For each food you have any sort of problem with you need to decide whether you can truly limit your consumption to special occasions or whether you need to eliminate that food entirely. This may seem rather harsh, but for virtually everyone a complete ban is actually easier than a plan to moderate consumption. It is an addiction after all.

Here are three tips to control cravings.

·         Is it hunger? Eat cold meat or a boiled egg.

·         Desperate for something sweet? Rinse your mouth out with dry wine, lemon juice or vinegar.

·         Desperate for something salty? Eat something sweet like a square of high cocoa chocolate or suck an artificial sweetener tablet.

If you do go ahead and guiltily get tucked into your personal equivalent of my Pringles problem, what do you do next? Many people will do the manana, manana thing. I�ve done it now, so I may as well have toasted cheese, the kids' smarties, the leftover quiche and start again tomorrow. No. No. No. Says Dr Gullo. You must get back on the wagon right away. You are not on death row. This is not your last meal. There are lifetime consequences on your health you know. You need to eat foods that you like and are nutritious and that fill you up. And you must do this consistently.

The best foods to fill you up are white meat, fish and seafood, high fibre low starch vegetables and eggs. High calcium dairy foods, grapefruit and cinnamon can also enhance weight loss. Removing unnecessary fat from you meals by attention to cooking methods. Removing dressings and sauces also helps. Be careful to avoid alternatives such as �lite� dressings that are bulked out with sugar. Just cut them down.

Drinking water, eating meals that contain a fixed amount of calories and exercise are all strategies that help weight loss.

As we know the first and last three minutes of our lives are the most dangerous. And it�s a bit like this when you go into a restaurant. In the first ten minutes you are choosing what to eat and drink and are possibly getting stuck into the bread and butter. In the last ten minutes you have the desserts and cheese and biscuits and the bill to contend with.

Once you are a weight you are happy with it can be just as hard to keep it off. To do this you need to keep to your good habits and not go back to your self defeating ways. Remember that it will be the same old stuff that is likely to trip you up. You may have lost a lot of weight but you will never lose your vulnerability to the old habits.

As a society we do tend to reward ourselves with food as we celebrate life events and relieve our misery over daily events. How can you reward yourself differently? How can you promote healthy eating habits to get the best out of your life?

TEST YOUR KNOWLEDGE

Ring your answers - the correct answers are at the end.

1. Who is responsible for your diabetes management?

A. You      B. The Consultant      C. The Diabetes Nurse      D. Your family

2. Which three of these parts of the body is affected by long term high blood sugars?

A. Heart     B. Eyes      C. Bones       D. Feet

3. Damage to nerves starts at blood sugars over which level?

A. 4          B. 8             C.12              D.16

4. For insulin users it is safe to go straight onto a low carbohydrate diet

as long as you have..

A. Thrown out all your crisps, cereals and biscuits.

B. Bought a good low carb book to help you.

C. Bought in plenty of meat, vegetables and olive oil.

D. Planned out a gradual reduction in carbohydrates and appropriate reduction in your insulin with a knowledgeable heath professional.

5. What foods cause a rapidly high blood sugar level?

A. Starch such as bread and potatoes.

B. Meat such as fish and burgers.

C. Vegetables such as cauliflower or broccoli.

D. Fat such as butter and cheese.

6. Your HbA1c test is?.

A. A test of whether you are anaemic or not.

B. A test of your blood sugar control over the last week.

C. A test of your blood sugar control over the last two months.

D. A test of your blood sugar over the last year.

7. Useful strategies to control your weight are to?.

A. Write down everything you eat.

B. Write down how miserable you feel about being fat.

C. Write your will.

D. Write to Santa Claus.

8. You should eat?.

A. Only when you are hungry.

B. Regularly every 4-6 hours throughout the day.

C. Everything that is on your plate.

D. Everything that is in your fridge.

 

9. A useful strategy to help you eat less includes?.

A. Miss out breakfast when you are not hungry anyway.

B. Divert yourself by reading or watching television to take your mind off the food.

C. Stop cravings by eating a little of the food so it has less power over you.

D. Measuring out your portions.

Answers

Question 1 - answer A Although many people with different areas of expertise can help you with your diabetes the eventual responsibility for the things you do and the decisions you take is YOU.

Question 2 - answer C. There is practically no tissue in the body that is not affected to some

extent by ongoing [chronically] high blood sugars but bones don't seem to be affected.

Question 3 - answer B. Chronic blood sugars over 7.8 (UK) or 140 (US) cause irreversible nerve damage.

Question 4 - answer D. It is essential that you plan the start of a low carb diet with care when

you take insulin and indeed any drugs that lower blood sugar to prevent hypoglycaemia.

Question 5 - answer A. Bread and potatoes can break down about as rapidly as sucrose.

Question 6 - answer C. The HbA1c corresponds to the amount of sugar in the blood over the last 2-3 months.

Question 7 - answer A. Keeping an accurate food diary helps.

Question 8 - answer B. Regular meals help prevent unnecessary snacking or loss of control due to hunger when you do eat.

Question 9 - answer D. Measuring out your portions helps. Satisfy your craving just a little bit? You have got to be kidding.

 

NHS NEWS

Investigations into the profits pharmaceutical companies make from the sale of drugs to the NHS - the Office of Fair Trading [OFT] is holding an inquiry to check whether safe and effective branded prescription medicines are being provided at reasonable prices to the NHS. The current Pharmaceutical Price Regulation Scheme [PPRS] is a voluntary agreement negotiated every 5 years between the Dept of Health and the Association of British Pharmaceutical Industry [ABPI] and the current agreement is due to run out in 2010. The PPRS sets a cap on the profits that each drug company can earn on its annual sales of branded medicines to the NHS. The inquiry is expected to take until the end of 2006. The results could be interesting?

NHS to merge local services

The government has announced that the number of primary care trusts [PCTs] are to be reduced from 303 to 152 and all the new organisations will be established by October 1 2006. The population covered by each PCT will rise from an average of about 165,000 to an average of just below 330,000. NHS ambulance trusts will also be merged from 29 into 12.

Out-of-ours service - the National Audit Office's [NAO] report on the handing over of out-of-hours health services [nights and weekends] from GPs to primary care trusts [5.5.06] showed the switch cost £70m, 22% more than the government allocated. Only 15% of PCTs met the requirement to provide emergency consultation at the healthcentre within an hour or urgent consultation within 2 hours. Only 2% managed to answer phone calls within a minute and only 8% began a clinical assessment of urgent calls within 20 minutes. The head of the NAO commented that PCTs are getting better but expressed disappointment that so few providers of the service are meeting their targets for the time it takes to respond to patients.

GPs to address obesity problems - Tony Blair and health minister Caroline Flint have announced that every GP will have to tell overweight patients that they should lose weight, with children and young people being particularly targeted. [4.5.06] GPs will have to treat obesity as if it is a medical condition and advise overweight people to slim and obese people, regardless of age, to eat less, improve their diets and take exercise. They are also expected to encourage people to join leisure centres and children to have 60minutes exercise a day. [Our sympathies probably have to go to GPs - as this can't work in isolation!]

Dignity nurses to protect elderly patients - are to be appointed in every hospital to tackle age discrimination and ensure the elderly are treated with respect after evidence has emerged of the mistreatment of elderly people in hospitals. [20.4.06] [Treating older people with respect and dignity used to be common courtesy!] It is expected that national hospital ratings by the Healthcare Commission will now cover dignity issues with guilty hospitals downgraded. However, it was admitted there is no new money to fund this proposal!

Scottish Parliament keeps prescription charges - MSPs voted to keep prescription charges following a debate in the Scottish Parliament in January. However ministers have promised to reform the system and introduce more exemptions for chronic conditions, students and those on low incomes

PRIVATE "TYPE=PICT;ALT="RESEARCH NEWS

Stress can delay healing

Researchers at Ohio State University team focused on 42 married couples and found wounds on hostile couples healed at 60% of the healing rate for non-hostile couples. Levels of interleukin-6 (IL-6), a key immune system chemical that controls wound healing, were found to be particularly raised in the hostile couples. Published in the Archives of General Psychiatry the findings showed that hospitals should try to minimise stress for patients ahead of surgery, as this could lead to shorter hospital stays and save money. Professor Steve Bloom, an expert in stress at Imperial College London, said "these findings are interesting, and illustrate yet again the control that the mind has over the body." As wound healing can be a problem for people with diabetes, this research may be of interest!

New developments in targeting kidney treatment

One of the long-term complications of diabetes can be kidney disease, called nephropathy. Initially the kidney becomes leaky so protein [albumin] appears in the urine and at later stages it may affect the functioning of the kidney. Researchers at Glasgow University have developed a new method for targeting treatment of kidney problems. They knew that the kidney was a difficult organ to treat because it is difficult to access with traditional drugs so they developed a new technology to allow drugs to target the kidney directly whilst still being administered through the rest of the body. They believe that this technology reduces the toxicity of the drug and increases its effectiveness. These are positive results and so a further grant from Kidney Research UK has been awarded to carry on with the research.

Dental care may help manage diabetes

Diabetes increases the risk of periodontal disease as a result of bacteria feeding on the excess glucose present in the saliva in people with diabetes. A study [April 2006 Journal of Periodontology] investigated whether common non-surgical gum treatment, scaling and root planing, would improve the blood glucose control of people with Type 2 diabetes and gum disease. They found that the treatment improved their HbA1cs [measure of average blood glucose levels over the last 6 to 8 weeks] from 7.2 to 5.7. The researchers made the point that reductions of this level could reduce the risks of diabetic complications and they recommended that further research is carried out involving more patients and comparing the effect of this treatment in people with diabetes and those without.

Diabetes and erectile dysfunction - erectile dysfunction is common in men with diabetes but a study carried out in Israel suggests that there are ways of cutting the risk. [Diabetes Care July 2005] The study of 1040 men with diabetes with an average age of 57 involved participants answering questionnaires about their lifestyle and their doctors then filled in another questionnaire about their diabetes, treatment, complications and general health. The information from both questionnaires was combined and the showed that only 13.5% had 'normal' erectile dysfunction and in the remaining 86.5% it was mild to severe.

The study showed several things that increased the risk of erectile dysfunction:

·         the older the man and the longer he has had diabetes

·         poor diabetes control

·         the presence of complications - heart disease, nerve, kidney and eye damage

·         water tablets to treat high blood pressure.

The risks can be cut by better diabetes control and switching to a different type of drug to treat high blood pressure. The research also showed that men who were physically active at work or leisure had a lower risk of erectile dysfunction and so did men who had one alcoholic drink a day.

Cocktail of drugs offers hope for reversing diabetes - doctors have developed a mixture of two drugs that could reverse Type 1 diabetes. The cocktail combines a monoclonal antibody which calms the immune system with a peptide that acts like a vaccine to protect the insulin-producing cells. The approach focuses on teaching the immune system to tolerate rather than attack the insulin-producing cells. The adverse effects of suppressing the immune system is that it makes it increases the risks of cancers and viral infections but by combining these two drugs this risk is reduced because a lower dose of the immuno-suppressant antibody is needed. Trials of the monoclonal antibody in humans have already shown it can reverse Type 1 diabetes but the diabetes returned after a year. The results suggest that when combined with the peptide, the two drugs act together to produce a greater effect than either one individually. The combination has only been tested in animals but each of them individually is already being tested in human clinical trials. The researchers hope to begin human trials later this year but is waiting approval from drug safety regulators.

THIS IS ONE TIME THAT YOU DON'T BELIEVE THE HEALTHCARE PROFESSIONALS!

We are receiving lots of calls from people who have been told by pharmacists, nurses and doctors that animal insulins are no longer available in the UK. It is often said with great authority but it is simply not true. Here is the truth:

Novo Nordisk are discontinuing all their pork insulins - Pork Actrapid, Pork Insulatard and Pork Mixtard but they expect stocks to last until the end of 2007.

Wockhardt [formerly CP Pharmaceuticals] are continuing to supply pork and beef insulins in both vials and cartridges for pens.

Unlike Novo Nordisk, Wockhardt supply the above pork insulins in 3ml cartridges are for use with a pen and this has to be the Autopen Classic made by Owen Mumford - dosages are 1-21units and 2-42 units, available on a GP prescription.

Wockhardt also supply a range of beef insulins:

·         Hypurin Bovine Neutral [short-acting] in vials and cartridges

·         Hypurin Bovine Isophane [intermediate acting] in vials and cartridges

·         Hypurin Lente [24hours] in vials only

·         Hypurin Bovine PZI [30hours] in vials only

FROM OUR OWN CORRESPONDENTS

Newly diagnosed

Dear Jenny

I received your information pack today. Excellent!!!!! The information is just what I am looking for it answers the questions we really have. Clearly you are dedicated to the cause so well done you must be very proud of your achievements. Have only read the January Newsletter so far and many of my questions have been topics of discussion so I'm off to bed to read the October one.

Thank you again!

Mrs J.S. by e-mail

I was diagnosed with Type diabetes in 1941

Dear Jenny,

As a newcomer to your mailing list, may I say how much I enjoy reading your Newsletters and all the information they contain.

I am 70 and became an insulin dependent diabetic in 1941, when I was 5years old. In 1987 the diabetic consultant decided that human insulin was for me, and over the following 5 years I went through hell. I asked him on numerous occasions to put me back on to pork insulin, but he refused. I had hypos three or 4 times a week at night and lost all the recognition signs of a hypo approaching. I also had neuropathy in my legs and even morphine could not suppress the pain.

My wife finally took me to our GP and thankfully he agreed to put me back on pork insulin and I started to feel better in 48 hours.

Mt present consultant tried me on Lantus which gave me excellent control for 3 years and then the hypos started again.

I now use Hypurin Porcine Neutral and Hypurin Porcine Isophane from Wockhardt which suits me very well.

Mr S.W.