INSULIN DEPENDENT DIABETES TRUST

 

January 2004 NEWSLETTER

 

 

2004 IDDT'S 10^TH ANNIVERSARY!

A time for celebration or for sadness?

 

 

This is a quote from one of our new members, someone treated from diagnosis with synthetic GM insulin and someone who had never been given the choice of using animal or synthetic insulins - until that is, he found IDDT. Only people with diabetes and their carers can truly realise the full impact that loss of hypo warnings has on their lives but even those of us that can only imagine what it must be like, can appreciate the huge improvement that regaining hypo warnings must make. For this one man, IDDT made a real difference but he is one of many and we should celebrate our 10th Anniversary!

 

IDDT was formed in 1994 with very specific and clear aims - firstly to achieve recognition that some people cannot tolerate synthetic GM insulin, then very misleadingly called 'human' insulin. Secondly we wanted the choice of natural animal insulins to remain available not only for this group of people but for people in the future who may the experience problems with synthetic GM insulins.

In 1994 five angry people joined together to form IDDT. We had just two things in common, our need for animal insulin and our experiences of not being listened to or believed by our doctors or by Diabetes UK, then the British Diabetic Association, when describing the adverse effects of 'human' insulin. We all experienced being dismissed as neurotic or extremist with some sort of axe to grind. We all had voluntary roles within Diabetes UK and so knew for certain that nearly 3000 other people had complained to them of similar experiences, so if we were neurotic extremists, so were 3,000 other people! Of course, we also knew that the way 'human' insulin was introduced left a great deal to be desired. It was foisted on the UK market with indecent haste with no large-scale long-term trials comparing animal and synthetic GM 'human' insulin and with no evidence of benefit to people with diabetes. 84% of the diabetic population were changed to synthetic insulin on the assumption that it was better, not on the evidence that it was better. Is there any wonder that we were angry?

 

But with our anger was also disappointment and disbelief.

Synthetic 'human' insulin was a new drug and the first drug ever to be produced by genetic modification so we naturally had expectations of our doctors and healthcare professionals and especially the 'experts' in diabetes. We expected them to be aware that there may be adverse reactions to a new insulin and to believe their patients when they complained of problems that had occurred after changing to the new GM insulin. We expected them to simply change people back to the animal insulin that had suited them well in the past. Indeed, we expected them to report the adverse reactions to the Committee on Safety of Medicines and to the insulin manufacturers. We also expected them to be very cautious in the use of 'human' insulin until more research had been done to provide the evidence that they and their patients needed. Rarely did we see this happen.

We were angry and disappointed that Diabetes UK chose not to publish the research that they had carried out into the reports of adverse effects that 'human' insulin caused. We were angry that they did not use their considerable influence to widely publicise the difficulties that were occurring with synthetic GM insulins or to ensure that good quality research was carried out to investigate these difficulties. They did send a petition to the insulin manufacturers but it is difficult to believe that they really thought that this was likely to influence the strategies of multi-national drug companies!

We weren't disappointed with the drug companies as we were aware that their job was, and is, to make profit for their shareholders but we were angry and shocked at the tactics they used to make sure that 'human' insulin became first line treatment. Perhaps it was the first time that we realised that it is the might and power of multi-national pharmaceutical companies that actually dictates our treatment, until then we had naively believed that our doctors did this!

 

So should we greet IDDT's 10^th Anniversary with celebrations or sadness?

Perhaps the answer is both. Yes we are sad:

·         10 years later we are still fighting for continued availability of animal insulins so that choice is available but the sadness is greater because we are doing this alone, without the support of the majority of medical and nursing professionals or national and international diabetes associations.

·         It is sad that there is a lack of respect for people with diabetes and their carers, shown by their experiences not being considered as valid evidence - a polite way of saying they are ignored or not believed. This is a group of people who are able to manage their own diabetes for the 365 days a year with a couple of 30 minute clinic visits a year, yet their experiences fall on deaf ears. The reality is that many people who want to change animal insulin still have to go into battle with their diabetes teams to do so.

·         We are sad that people with diabetes are not being given the informed choice of insulin treatment to which they are entitled and diabetes teams are prepared to risk breaching this very basic right of patients.

·         Perhaps the greatest sadness is that 10 years on, insulin treatment is not based on evidence of benefit for patients - there is none! But perhaps even more disappointingly, the leaders in the diabetes community do not seem concerned by this!

 

But on the 10^th Anniversary of the formation of IDDT we can celebrate:

10 years later IDDT has grown from 5 angry people to an international organisation with members in countries throughout the world. Had the accusations that those 5 angry people were neurotic extremists been true, then IDDT would never have become the independent international patient/carer organisation that it is today. If our case that synthetic GM insulins are not suitable for everyone is not justified, then our opponents would have wiped the floor with our case long ago. If our experiences did not reflect those of many other people, then IDDT would not be in existence now - we would have collapsed for lack of support and lack of funds.

 

So 2004 is a year to celebrate!

·         We still do have animal insulins in the UK and there are still over 30,000 people using them.

·         We do have an acknowledgement from the Dept of Health that some people are better suited to animal insulins.

·         We have gathered information from large numbers people in various countries who have experienced difficulties with GM insulin.

·         The Cochrane Review has demonstrated that our concerns are justified. It confirms that synthetic GM insulins are not superior to animal insulins, that the majority of the research that has been done is 'methodologically poor' and that the vital research into complications, mortality and quality of life has never been done. 

We should celebrate that we are perhaps the only international patient/carer organisation that is entirely independent, unfettered and uninfluenced by pharmaceutical industry or their funding and we should celebrate the freedom that this provides. We are free to question, to criticise and to praise and we only have one responsibility, our duty to people with diabetes.

10 years on, we should celebrate the formation of IDDT. Every letter, e-mail or phone call that starts with 'You have changed my life….' confirms this!

 

 

THE BLACK TRIANGLE

"Report any adverse reactions to CSM"

MIMS is an independently written monthly publication designed as a prescribing guide for GPs and it is sent to all medical practitioners free of charge. Various symbols are used to help readers. A black triangle is used to show that ALL suspected adverse or unexpected reactions, however minor, should be reported to the Committee on Safety of Medicines [CSM] using the Yellow cards scheme, even though it is flawed it is the only system we have. The black triangle is usually used for new drugs but this classification seems to go on for some time.

We know that there seems to be an unwillingness to report adverse reactions to the CSM so it may be useful for readers to know which insulins have a black triangle.

 

Quote from MIMS "Report any adverse reactions to CSM" for the following:

Novo Nordisk	Aventis
NovoRapid [aspart, short-acting analogue]	Lantus [glargine, long-acting analogue]
NovoMix 30 [pre-mix aspart and protamine insulin aspart]	Insuman Rapid  [short-acting analogue]
	Insuman basal [intermediate-acting human]
	Insuman Comb [pre-mix human neutral and isophane]

 

Remember to ask your doctor to report any suspected adverse reactions because it helps to build up a picture of the drug/insulin and this will help to ensure its safety, inform prescribers and provide a more informed choice for patients in the long run.

 

 

FIRST CELEBRATION OF 2004

Welcome to IDDT- India

We are delighted to welcome India into the IDDT-International fold and we say a warm welcome to people in India. It is great that we are widening our presence. The site is very informative and provides information pertinent to both medical and healthcare professionals as well as to people with diabetes.

Because of the situation in India, IDDT-India is set up differently from IDDT in other countries in that the Trustees in India are all leading medical experts in diabetes and we are very grateful for their time and commitment. However, in other respects IDDT-India functions in the same way - people can become members and any donations will be sent to IDDT in the UK.

The formation of IDDT- India is unrelated to the support IDDT and many of you offer to the children and young people with diabetes at Dream Trust but our involvement has helped us to realise the enormous problem that faces people with diabetes in India.

As you know in India many people cannot afford the insulin they need and when they can, their choice is often governed by cost. It is essential that it is known that animal insulins are available in India, that they are not inferior to synthetic GM insulins that are now being marketed to them and that they are cheaper. We are grateful to all the people who have helped in the formation of IDDT-India and to the Board of Trustees.

If you have internet access, do visit the website there's interesting information for everyone! You will find it at www.iddtindia.org

 

 

 

 

GOOD NEWS!  AUSTRALIAN GOVERNMENT CLASS BEEF INSULIN AS AN 'ESSENTIAL MEDICINE'

The fiasco in Australia when imports of beef insulin were suddenly stopped because of one 'Mad Cow' in Canada, showed just how easily supplies can be halted. Ian Kershaw who runs the website for IDDT-Australia contacted his MP to try to ensure that the beef insulin he and many others need, will continue to be available. His MP asked a Parliamentary Question and the Australian Minister response was that beef insulin is classed as an essential medicine for people who cannot tolerate synthetic 'human' insulin. It is a major step forward because:

·         the Australian government is publicly acknowledging that some people cannot tolerate synthetic insulin

·         classification of beef insulin as an essential medicine must mean that the government has a duty to ensure continued access to beef insulin for people who need it.

This is recorded in the Australian Hansard for all to see. It will help people in Australia and is a major breakthrough for people in other countries too. It is the first government statement that animal insulin is an essential medicine and as such must remain available. It remains to be seen just how this would be put into operation, should manufacturers decide to discontinue production………Nevertheless, we congratulate the Australian government for listening to people with diabetes and truly acknowledging their needs. Let us hope that other countries follow their lead.

 

 

WORLD DIABETES DAY ANNOUNCEMENT

November 14^th 2003

·         US Research Breakthrough for Type 1 Diabetes

US researchers at Massachusetts General Hospital have been able to halt, and even reverse, Type 1 diabetes in mice. The researchers had already shown that injecting diabetic mice with spleen cells from healthy mice re-educated their immune systems so that they could accept an islet cell transplant. However, the mice unexpectedly began to produce islet cells that could secrete insulin themselves. This latest research found that this only happened if the mice had been given a specific type of spleen cell that can be distinguished from other spleen cells by their lack a particular molecule called CD45. It is the cells without CD45 that are the precursors for pancreatic islets and they have a distinct function that has not previously been identified for the spleen.

To double check their findings, researchers carried out the same treatment giving female diabetic mice spleen cells from healthy male cells. In the diabetic mice that achieved long-term normal glucose metabolism, all the new functioning islets had significant numbers of cells with Y chromosomes which means that they must have come from the male donors.

Dr David Nathan, director of the hospital's Diabetic Centre, says: "These exciting findings in the mouse model Type 1 diabetes suggest that patients who are developing this disease could be rescued from further destruction of their insulin-producing cells. In addition, patients with fully established diabetes possibly could have their diabetes reversed."

Clearly there is still along way to go, but things are looking more promising!

 

 

IDDT - THE VOICE FOR CHOICE

 

In his first speech as Health Secretary, John Reid said that the NHS will become a more personal service, focused on the needs of patients not providers and that capacity will be increased alongside an extension of personal choice for patients. It remains to be seen what Mr Reid means by 'personal choice for patients' but we would hope that he remembers it means a great deal more than just offering a choice of the NHS services we use. For people with long-term conditions such as diabetes, personal choice is more than simply choosing where or when we have our treatment. It is about sharing knowledge and information and about patients being partners in decisions about their healthcare.

As readers are aware, IDDT has long held this view and it is good to see it being expressed by the Long-term Medical Alliance [LMCA] in its response to the government's consultation, "Fair for all personal to you: Choice responsiveness and equity in the NHS and social care."

So Mr Reid has a big job on his hands! To achieve these vital changes there has to be a shift in the relationship between the NHS, the doctors and healthcare professionals within it, and patients. There has to be:

·         a commitment by health professionals to share knowledge and information with patients about all treatment options and this information must be based on unbiased evidence, not drug company sales literature.

·         a commitment that the views of patients will carry equal weight in decision making.

At the same time, many patients will need to develop the courage and confidence to be equal partners in this process.

Every day we manage and take responsibility for our own diabetes, sometimes better than others and some people better than others, but we all do it. Therefore, it is almost unbelievable that knowledge and information is not shared with us and that we are not equal partners in decisions-making about our health. While this concept may be new to the NHS, it has been discussed in diabetes for many years.

We believe that informed choice involves sharing information about the many aspects of diabetes and its management - different insulin regimes, diet, exercise, and the many other drugs that are often prescribed for us. We firmly believe that everyone requiring insulin treatment should be given an informed choice of synthetic GM or natural animal insulin. They should know that there are different types of insulin in case they have problems that can't be resolved and they should not have to enter a battle zone in order to try animal insulin.

 

Do people with diabetes really have an informed choice?

In the UK diabetes specialist nurses [DSNs] play a large role in the treatment of people with diabetes and often a major role in the decision making process. It is clear from the many reports IDDT receives, that DSNs play a huge role in deciding what insulin someone should use and they even persuade people not change insulins. There are legal issues here because DSNs are not allowed to prescribe and refusing to allow people to change insulin is still a prescribing decision. But the legal position bears little resemblance to the reality in diabetes care. So if we are to achieve an informed choice, and the sharing of all information and knowledge then it is vital that DSNs in particular appreciate that their role has to change.

 

Choice of insulins, pen devices and blood glucose meters: Factors influencing decision making by DSNs in the UK

This is the title of a recent study [ref 1] and in the light of the present recommendations for patient choice, it is amazing! Even the language contradicts the meaning of the words 'patient choice' - in the first paragraph is the sentence "The primary aim of this study was to identify which factors influence the thought processes of the DSNs when they are deciding which insulin type, pen device and blood glucose meter is suitable for their patient."

Who is deciding what insulin type is the most suitable for their patient? Apart from their own involvement in this decision, patients still like to think that those qualified to prescribe ie doctors, will be involved in this decision! This sentence alone, shows that there is a very long way to go before patients are equal part of the decision making process. Anyway, the study was carried out by questionnaire involving 227 DSNs who were asked to respond to statements with strongly agreed, agreed, disagreed, strongly disagreed.

 

Results!

·         DSNs felt that they predominantly chose the insulin type and only nine, 4%, did not autonomously initiate insulin treatment. They thought that patients more often chose the pen device and both had equal choice over meters.

 

·         Most DSNs felt that clinic time was adequate to provide a choice of insulin. Well it would be as 96% of DSNs chose the insulin type anyway! They said that patients were often too shocked to make such decisions - obviously not thought of the possibility of dealing with the immediate situation, then later discussing choice issues! They were less content about the time allocated to pen and meter choice.

 

·         Most DSNs agreed that their personal experience of a given insulin type would affect future choice and this was the top influencing factor on their choice.  This was followed by literature and pharmaceutical production of a particular insulin type. Patient literature explaining insulin types were stocked within most centres [88%]. Lilly and Novo Nordisk insulin and pen devices were stocked in most diabetes centres but availability of CP Pharmaceuticals insulins and Aventis were meagre. [The study was carried out before the introduction of Lantus.]  DSNs were ambivalent about whether they would alter their insulin choice if it were immediately available from stock but they would change their choice of pen or meter if they were not stocked.

 

·         Costs of insulin and equipment were least likely to influence choice but the majority of diabetes centres and patients do not pay for their insulin or consumables [strips etc]. Local policies determining exclusive use of an insulin brand may reduce overall costs and be influential. [In our language this means that by using insulin from a particular company, there is a discount.] Sounds like management choice rather than DSN or patient choice!

 

·         Local prescribing policies and pharmaceutical representative support were shown to have a modest influence over choice. 

 

Key conclusions of the authors

The authors concluded that DSNs are not giving newly diagnosed people with Type 1 diabetes choice, despite this group being in the younger age group. To 'empower' patients, suggests a shift in emphasis from the traditional model of 'doctor knows best' [in this case 'DSN knows best'!] to a more patient centred approach. As choice is so important they question whether prescriptive protocols and pharmaceutical contracts are appropriate.

 

So how is informed choice ever to be achieved?

The study describes the DSN role as 'pivotal and often autonomous' in starting insulin treatment but shows that the greatest factor in influencing their choice of insulin is their own experience. As most of them trained after the introduction of GM insulin they have little or no personal experience of pork and beef insulins, so will we ever get to a position of patients being given a fully informed choice of insulin?

Clearly the other important factor that this study highlights is local pharmaceutical contracts ie discounts for sole use of a brand of insulin. It is obvious that this happens because certain areas are obviously Novo Nordisk and others are Lilly! But for patients to have an informed choice of insulin and for Mr Reid's wishes to come true, these local deals have to stop.

While pharmaceutical representative support was shown to have only a modest influence over choice, it shouldn't have any at all!  This is biased and not evidenced based.

Perhaps of greater concern is that at no point did the study raise the issue of the decisions of DSNs being based on evidence from research. If DSNs have this 'pivotal and often autonomous role' in starting insulin treatment despite the questionable legality of this, then surely patients should expect that these decisions are based on evidence from independent research.

 

IDDT's actions for our Anniversary year, 2004

The delegates at the Annual Meeting 2003 came to a clear conclusion - people requiring insulin treatment are not given an informed choice of treatment, especially in relation to insulin types. If professionals are not doing it we must and this is the main objective for 2004 - reaching people with diabetes and sharing knowledge and information with them. IDDT has to become the 'Voice for Choice'!

Ref 1 Pract Diab Int Sept 2003 Vol 20 No7

 

 

ASPARTAME

In our last newsletter we told you about John who by totally cutting out aspartame [also known as Nutrasweet] from his diet found that the increasing joint/muscle pains and fatigue that he had been experiencing were greatly reduced. We asked you to tell us about your experiences with aspartame and we are grateful to all those who responded.

 

But first, just for the record, what is aspartame?

It was first intended as an ulcer drug and the scientist developing it happened to taste it and found that it was sweet. It is composed of 3 chemicals 50% phenylalanine, 40% aspartic acid and 10% methanol. Ingesting high amounts of phenylalanine results in a build up of it in the brain and this potentially decreases the amount of seratonin in the brain. This in turn can result in depression and mood disorders. Once ingested aspartame converts to formaldehyde and formic acid. [For those who did biology at school formaldehyde is the embalming fluid used to keep animals for dissection and is a Class A carcinogen!]

The FDA in the US refused to approve asapartame for more than eight years because of seizures and brain tumours it produced in animal studies. In 1981 it was finally approved for use in dry goods and since then it has been approved for use in every type of food product. In 1994 The US Dept of Health and Human Resources reported more than 90 symptoms of aspartame poisoning including headaches, weight gain, muscle spasms, heart palpitations, nausea, fatigue, anxiety attacks, fibromyalgia and so the list goes on!

 

So what did you tell us?

·         Quite a few people have found that aspartame has caused them very real problems but all of them had to find this out for themselves, usually via the internet and not from their doctor or health professional. They found that cutting out all food and drinks containing aspartame reduced or removed their symptoms.

 

·         One of our members said that aspartame caused her to have fibromyalgia symptoms. Fibromyalgia is a collection of symptoms rather than a specific disease and characterised by widespread pain for more than 3 months and one of the other symptoms is sleep deprivation. Interestingly recent studies into causes of these sleep problems have identified a deficiency in seratonin [remember above!] in the central nervous system and the result is Disordered Sensory Processing where the brain registers pain when others might experience a slight ache or stiffness.

 

·         One lady told us she had suffered with interstitial cystitis [chronic inflammation of the bladder] for over 10 years. Her doctor prescribed antibiotics each time and she was referred to a urologist for tests and surgery with no success. She then found the website of the Interstitial Cystitis Support Group where one of the suggestions was to exclude certain foods from her diet for two weeks and then bring them back in one by one to find out if any of them produced symptoms of cystitis. She did this and found that an hour after drinking a low sugar drink containing aspartame, she had cystitis symptoms and even the tiny bit of aspartame in reduced sugar Tomato Sauce caused a reaction. She has cut out aspartame from her diet and has been free from interstitial cystitis for 6 months.

Clearly many people are unaffected by aspartame but it certainly has adverse effects on some people and as the article in the last Newsletter said, as a group, people with diabetes probably consume more aspartame than any other group of people.

 

Note: If you want information about fibromyalgia, contact the Fibromyalgia Association UK on 0870 2201232 or an interesting website www.fibromyalgiasupport.com

 

 

ACTION!

IDDT GOES TO WESTMINSTER

In the UK we have watched the discontinuation of pork and beef insulin in countries around the world. We have done all we can to help people but the discontinuations have progressed. People have been denied the insulin they need, the insulin that suits them best and for no other reason than the commercial decisions of the pharmaceutical companies, in other words, profit.

Can we let this happen in the UK? The answer to this is simple - not without a fight.

 

Can we actually stop it happening in the UK? We don’t know but we have to do all we can to try to stop it. We are also realistic in that we know that the power, the money and the influence of the insulin manufacturers cannot be underestimated. We also know that most of our doctors and healthcare professionals do not seem willing to use their power and influence to support people who need animal insulins or even to support choice.

 

Why are we asking these questions now? There are individual people in some EU countries who are still managing to obtain Novo Nordisk animal insulin by one means or another, but they have been told that manufacture will cease in 2005. So we have to wonder how likely it is that Novo Nordisk will continue to produce their pork insulin just for the UK market?

 

The UK situation is different, let's take a look:

It has always been different because we have two suppliers of animal insulins - the  multi-national company, Novo Nordisk and also by British-based CP Pharmaceuticals who make pork and beef insulins and do not make synthetic insulin. So we have always had choice, even if we haven't been given that choice.

In other countries, two multi-nationals Novo Nordisk and Eli Lilly have been the main suppliers. While they are business competitors for insulin sales, strangely [or not so strangely!] their commercial decisions to discontinue animal insulins have been the same, right down to the timing and the order in which the insulins have been discontinued. This has left people with no choice but to use synthetic GM insulins, something that both companies wanted to achieve if for no other reason than it is much cheaper to only have to produce one type of insulin.

 

Don't panic!

IDDT has to consider the possibility that 2005 could be the year in which Novo Nordisk decide to discontinue pork insulin in the UK. IDDT would be failing in our duty if we did not take this possibility seriously. At the same time, we emphasise that we have NOT formally been told this, but in October 2002 when Novo Nordisk agreed to continue the supply of pork insulin in the UK, they did say that this strategy would be reconsidered from time to time. So please don't panic! To Novo Nordisk pork insulin users, remember that CP Pharmaceuticals produce a range of pork and beef insulins in vials and cartridges for pens.

 

Having said don't panic, we cannot sit back and let this possibility become a reality.

We have again contacted the International Diabetes Federation and they happened to be meeting Novo Nordisk a week later and promised to let IDDT know the position, but they did not. This lack of response is open to interpretation but they do not appear to want to support patients in the developed world who need animal insulin.

Over the years we have had dialogue with the Dept of Health and achieved a statement from them in 1998 acknowledging that some people are better suited to animal insulin and should continue with treatment with animal insulin. But the Medicines Control Agency [now MHRA] also part of the Dept of Health, has continually stated that the insulin manufacturers have said that they will continue to supply for the foreseeable future and more importantly for us, that they cannot interfere with the commercial decisions of companies.

The 'foreseeable future' is a meaningless statement and offers no reassurance. But having admitted that some people need animal insulin, for the Dept of Health to then state that they 'cannot interfere with commercial decisions' means that they are not, or cannot, offer protection to this group of people. What exactly does the Dept of Health expect to happen to them? The logical conclusion from there two statements is that the Dept of Health is prepared to let this group of people suffer severe adverse reactions affecting their health, their life and that of their families. This is totally unacceptable and has left us with no other course of action than to enlist the help of our politicians.

 

Westminster visits

With the help of a political adviser, we have already visited the Houses of Parliament to meet MPs, an MEPs and a member of the House of Lords all of whom have a special interest in health. We received sympathetic, supportive and very helpful responses from all of them and they all agreed to follow this up, including asking Parliamentary Questions, writing letters to the insulin manufacturers and other relevant people and organisations. Several Parliamentary Questions [PQs] have been asked, answered by the Minister of Health responsible for diabetes, Rosie Winterton, and are being followed by pursuant Questions as her answers have not given the reassurances that we need. PQs not only raise the issue in the House but they and the Minister's responses are recorded in Hansard for all to see and forever. So no one, including government, can later say that they were unaware of the problem.

It may be that we will ask you help by contacting your MP and MEP but in the meantime we are following the parliamentary process and we will keep you informed of our progress. We would like to express our gratitude to all the politicians who have given up their time to meet with us and to follow up our very real concerns.

 

But you can help now!

In 2004, IDDT will be taking steps to try to reach the 30,000 people who are using animal insulin to ask then to support our battle to maintain supplies. But this is no longer a battle just to be fought by people who need animal insulin, it is a battle in which we need all the support we can get. IDDT needs the support of the public, of your friends and your relatives. We are not asking for their money, but yes we're asking them to join us to fight the battle for the insulin we need. We're also asking them to fight an even bigger issue which could affect everyone in some way or another. We are asking them to support us to stem the tide of global multi-national pharmaceutical companies being able to dictate and control our health, our lives and our futures.

 

We're not asking for a lot:

Diabetes may be complicated but our message to your friends and family is not.

We aren't asking for an expensive medication to be put on the market, we are asking for a medication to stay on the market, one that will certainly not cost the NHS more and in many cases cost less than the newer insulins.

Ask your friends to use their imagination!

Imagine you or your child having a lifelong condition that can only be successfully treated with one type of medication. Imagine a situation where that medication is denied to you or your child simply for money. What would you do? You'd fight tooth and nail for that medication, so please help us. 

In terms of decency and morality, the discontinuation of a perfectly safe medication that is essential to a significant number of people, simply does not stand up to scrutiny.

 

Ask your friends and relatives to support you and IDDT by joining our supporters' list. Just send their names and addresses to Bev, Supporters, IDDT, PO Box 294, Northampton NN! 4XS or e-mail supporters@iddtinternational.org

 

 

RECENT COCHRANE REVIEWS

These regularly updated reviews look at randomised controlled studies on particular topics, assess their quality and draw conclusions from them to provide high quality evidence on which treatment choices can be made by both physicians and patients.

 

Surgical versus non-surgical treatment for carpel tunnel syndrome

July 2003

Carpel tunnel syndrome is caused by the median nerve being trapped in the wrist [see IDDT Newsletter July 2003] and causes tingling, numbness and pain in the hand. Surgical treatment is widely preferred to non-surgical treatment for people who have significant symptoms but mild cases are usually not treated.

This review compared the effectiveness of surgical and non-surgical treatment with splints or corticosteroid injections. Only two small randomised controlled trials were found and the reviewer concluded that surgical treatment of carpel tunnel syndrome relieves symptoms significantly better than splinting but further research is necessary to discover whether this applies to people with mild symptoms.

 

Inhaled insulin instead of injected short-acting insulin appears no more effective for glycaemic control but may be preferred by people with diabetes July 2003

Six trials have been done giving inhaled short-acting insulin before meals in conjunction with an injected basal insulin but much of the evidence from these trials has not yet been published in full. The results show that glycaemic control with  inhaled insulin is comparable to that of people taking multiple daily injections and overall rates of hypoglycaemia appear to be similar. But the key benefits appear to be patient satisfaction, although again this information has not yet been published in full.

The reviewers say that it is too soon to know what the long-term effects on people's lungs are and that while inhaled insulin appears to be safe on the lungs, it will be 10 years before they can be confident about the long-term safety of inhaled insulin. Higher doses of inhaled insulin are required and this may make it less cost-effective than injected insulin.

About the Cochrane Collaboration:

To subscribe to the Cochrane Library visit www.update-software.com or contact Update Software info@update.co.uk  There is also a Cochrane Consumer Network that provides information and updates for consumers in easily understood, visit www.cochraneconsumer.com

 

 

 

 

 

STATINS - the anti-cholesterol drugs

Statins are the group of drugs used to lower cholesterol. They are presently the most expensive item on the NHS drugs bill despite their recommended use being limited only to people who have a 30% chance of having a heart attack in the next 10 years. One million prescriptions are issued every month at a yearly cost of £440milllion. There is some evidence that increasing the use of statins could save more lives if they were more widely available. People with diabetes are at greater risk of heart disease and so are quite likely to be prescribed statins. Studies have shown that statin treatment cuts the risk of heart attack and stroke and the evidence from a review in Bandolier [117, Nov 2003] suggests that they work as well in older people, over 65, as younger people under 65.

 

Statins may become over-the-counter drugs in 2004

The patent is due to run out in 2004 and for some time it has been widely reported that Ministers will not block the application by drug companies to make statins more widely available ie over-the-counter [OTC] without prescription. In November, Health Secretary, John Reid, announced plans for a 9 week consultation period on the move towards OTC sales of statins. The proposal is that pharmacists should be able to supply the drug, Zocor Heart Pro, after simple on the spot health checks and the government wants a low-dosage to go on sale for about £5.00 a week. It would be available to people at both high and moderate risk of heart attack.

This is a significant step because up to now the only drugs available OTC have been for symptom control and not prevention or treatment. It could also affect a larger population as the intention is to make statins available to lower risk categories of people even though there is little evidence that statins are beneficial to people at low risk of cardiovascular disease.

Apart from the safety issues involved, this move also raises both political and practical issues:

·         It shifts the health costs from society via the NHS to individuals, so would this mean that people who could not afford £5.00 a week be denied the preventative treatment? For a husband and wife the cost would be £10.00 a week.

·         Surely pharmacists would need access to medical records in order to judge whether statins are necessary and advisable? How are they going to gain this access?

·         What system would be in place for the the person's GP to be informed that the pharmacist has prescribed a statin?

 

But is making statin treatment available without prescription the best option for patients? Does it mean that people will pop a pill as the easy option in preference to trying diet and exercise with their many health benefits and without risking the adverse reactions associated with all drugs? Let's take a look……….

 

Measurement of cholesterol levels

A total serum cholesterol test measures the level of cholesterol in the blood to assess fat metabolism and the risk of heart disease. The cholesterol in the blood is made up of:

·         LDL [bad] cholesterol ie low density lipoproteins

·         HDL [good] cholesterol ie high density lipoproteins which have a protective effect on the heart

·         Triglycerides which are the white fat that is eaten with meat and are also made in the body from other energy sources such as carbohydrates. Any calories consumed that are excess to requirements are converted to triglycerides and stored in fat cells. High levels of triglycerides in the blood may be a sign of poorly controlled diabetes.

Cholesterol levels are usually measured either as total cholesterol when the aim is that people achieve less than 5 mmols/l or are measured as levels of LDL when the aim is that this is less than 3 mmols/l.

Note: diet is responsible for only 25% of the total cholesterol levels, the body produces the rest.

 

Diet and exercise

We are all aware that diet and exercise can reduce cholesterol levels, so diet and exercise is the first treatment and if this fails, then the use of statins may be recommended. Recent research in Canada [ Am J clin Nutr Sept 2003] comparing the effectiveness of lovastatin and a diet containing no animal products, no meat or dairy products, showed that this diet can reduce cholesterol levels as effectively as some of the latest and most expensive cholesterol-lowering drugs. The range of foods eaten in the study included high fibre cereals such as oats and barley, soya products, fresh fruit and vegetables and almonds. This research demonstrates that people can improve their cholesterol levels without medication. It is worth noting that The Lancet [Vol 352: Oct 25 2003] says that the safety of statins cannot be assured, citing the withdrawal of Bayer's statin after unexpected deaths from rhabdomyolysis as the reason.

 

Like any other drug statins can cause adverse reactions

Most of the statins on the market list similar adverse reactions - headaches, dizziness, gastro-intestinal upsets, myalgia and weakness. But only a couple of years ago, Bayer had to withdraw their statin from the market because of serious adverse effects. There are warnings [MIMS October 2003] that all statins may carry these same risks - muscle ache, reduced liver function and in extreme cases rhabdomyolysis [muscle wasting] and even total renal failure and these may occur particularly in people with renal impairment and hypothyroidism [under-active thyroid].

 

Statins are contra-indicated during pregnancy and breastfeeding

This warning is associated with all statins and most of them including Zocor state: "Pregnancy: women must be protected by non-hormonal contraceptive methods".

Examination of the FDA surveillance records has identified clusters of congenital abnormalities in infants exposed to statins in utero. [Lancet. Vol 362, Nov 25 2003]

 

Claims of other benefits

Laboratory studies have suggested that statins may have a favourable effect on bones and reduce osteoporosis but to date trials have had mixed results. A recent study [ref1] involving 93,000 postmenopausal women concluded that the use of a statin did not improve fracture risk or bone density and so the evidence does not warrant the use of statins to prevent osteoporois.

There have been claims that statins protect against Alzheimer's but the evidence is weak.

 

Can changing statins be harmful?

It appears that the recommendation is that only one brand of statin is to be available OTC but if more become available, people may well change from one brand to another without knowing whether this is good or bad for them. Research in New Zealand [ref 2] has shown that changing statins can make matters worse. An audit was carried out of 126 patients who had changed their statin. Hospital records were examined for fasting lipids and hospital admissions for unstable angina, heart attacks, thrombotic stroke and peripheral artery occlusion for 6 months befpre and 6 months after the change from simvastatin to fluvastatin. The average dose of 22mg of simvastatin was changed to 37mg of fluvastatin. The change resulted in a significant rise in total cholesterol of 18%, LDL [bad] cholesterol by 34% and tryglyceride by 13%. These significant increases occurred in 94% of people. There was also a threefold increase in total vascular events from 9 in the last 6 months on simvastatin to 27 in the first 6months on fluvastatin.

 

Can stopping statins be harmful?

Millions of people are taking statins but according to Bandolier [July 2003] even though they are prescribed by their doctors most people stop taking their statins after some time. If they become available OTC, it is not unreasonable to think that this is even more likely to happen.

A study [ref 3] of 3232 people who had chest pains, looked at the effects of stopping statins. 1151 patients had no statins at any time, 369 had statin treatment before their chest pain and continued with it afterwards and 86 people had statin treatment before the chest pain but this was discontinued at or after hospital admission with chest pain. The people on statin treatment had higher cholesterol levels after stopping it but the levels were still 10% lower than those who did not take a statin. However, the main difference was in the death rates and heart attacks in the 30 days after the onset of chest pain - these were lower in people who took a statin before and after the onset of chest pain. Those who had statins treatment withdrawn had higher rates and not just higher than those continuing on statins but higher than those who were never treated with a statin, though not significantly so.

 

So can we draw any conclusions?

John Reid says: "People have the choice to give up smoking and to improve their diet, we want them to be able to choose a medicine that will reduce the risk of coronary heart disease."

Public health must not be put at risk by making statins an over-the-counter drug. We would remind Mr Reid that choice is no choice at all, unless it is an informed choice and this informed choice must be include advice about diet and exercise.  So it would seem that pharmacists will have to function as dietitian and doctor and be very vigilant in warning people about the proper use of statins, the possible adverse effects and the contra-indications.

 

Ref 1 Annals of Int Med;2003;139:97-104

Ref 2 Increased thrombotic vascular events after a change of statin. Lancet 1998 352:1830-1831 M Thomas, J Mann

Ref 3 Withdrwal of statins increases event rates in patients with acute coronary syndromes. Circulation 2002 105:1446-1452 C Heeschen et al

 

 

RAE PRICE'S DIARY