Welcome to Insulin Dependent Diabetes Trust

In September 2004, Novo Nordisk gave 18months notice that they were discontinuing several of their GM 'Human' insulins due to 'rationalisation of their portfolio'. But they have now brought this date forward to October 2005 as they state that stocks will be exhausted by this date as a result of 'continuing high demand for these products'.

Obvious question: if these insulins are in high demand, why are they being discontinued?

In addition, Novo Nordisk have now announced that GM 'Human' Actrapid Penfill [3ml cartridge] will no longer be available after the end of October 2005. This means that people who want to continue to use 'human' Actrapid will be 'forced' to use a 10ml vial and syringe. Of course, the Novo Nordisk recommended alternative is that people change to the short-acting insulin analogue, NovoRapid.

Obvious question: if your doctor thought that NovoRapid was the insulin most suitable for you, then surely he would have already suggested changing to it?

Under these circumstances, changing your insulin is not being done clinical reasons to benefit you but because Novo Nordisk have made yet another commercial decision. It is this commercial decision, not clinical need, which is dictating your treatment - something that must be deplored!

NOTE: there has been NO announcement about the discontinuation of pork insulin.

Overleaf is a chart produced by Novo Nordisk giving the discontinuation details and possible Novo Nordisk alternative insulins. If you do not want to change to GM insulin analogues or you have already tried them and had adverse effects, then there are other alternatives to consider and discuss with your 'suitably experienced healthcare professional':

· GM 'human' insulins made by Lilly - having said this, Lilly announced some time ago that preloaded pens, HumaJect S and HumaJect M3, will not be available after June 2006 but they will still be available in alternative delivery systems. More information from Customer Care Tel 01256 315999

· Animal insulin by Wockhardt/CP Pharmaceuticals - GM 'human' insulins replaced natural animal insulins and while animal insulins differ in their speed and duration of action, GM 'human' insulins are still more similar in action to pork insulin than to GM insulin analogues. Animal insulins are available for pen use.

Novo Nordisk state that 'any change of insulin therapy should be carried out by a suitably experienced healthcare professional' . This is particularly so when changing to insulin analogues because they have a different speed of onset, peak of action and different duration of action from both 'human' and animal insulins.

Obvious question: how is this going to take place before October 2005 when many people only go to the clinic once a year? Let us hope that we do not have a similar situation to the 1980s when pharmacies supplied people with GM 'human' insulin instead of their usual animal insulin without any information or professional advice. .

Again we see commercial decisions dictating treatment options, further reducing treatment choices for both patients and doctors, not to mention increasing NHS costs. We will be raising all these issues with Minister of Health, Lord Warner in July 2005.

November 14th 2003

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 and the latest research found that this only happened if the mice had been given a specific type of spleen cell. They can be distinguished from other spleen cells because they lack a particular molecule called CD45. It is the cells withut 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. They found that 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. In a further experiment, donor spleen cells were marked with fluorescent green protein and again these cells were found throughout the newly developed islets.

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

When IDDT first formed in 1994 an important task was to collect information from people with diabetes and their family carers about their experiences with synthetic, so-called 'human' insulin. We sent questionnaires to everyone who contacted us and analysed the first 100 we received, the questionnaires that were received subsequently were all very similar to the first 100. We received the following information from this group of people:

· 41% - loss of warnings of hypos or ‘I seem to function on automatic pilot’.

In addition to this 24% Of those contacting IDDT said that their doctor was unwilling or reluctant to change their insulin to natural animal insulin and 3% told us their doctor didn’t listen or said the problems were ‘all in the mind’.

· ‘I didn’t realise that ‘human’ insulin was not derived from humans’.

The National Institiute for Clinical Excellence [NICE] has advised that Tamiflu, an anti-flu pill, should be made available on the NHS to people 65 and over and younger people with serious health conditions, including diabetes. Tamiflu is the only treatment that can be taken orally in a capsule or syrup and is the first drug to be licensed to treat flu in children.

It is designed specifically to target the influenza virus by stopping the virus sticking on to the cells of the respiratory tract. Normally the virus then reproduces but Tamiflu also stops this happening. It works in the same way as Relenza but this has to be inhaled, making it hard for some elderly people to take.

The chief executive of NICE told the BBC that vaccination is still the most effective way to prevent flu-related illness but Tamiflu increases the options for at risk groups.

People with diabetes are an at risk group and therefore entitled to free flu vaccinations on the NHS.

The Novo Nordisk range of synthetic human insulins are to undergo a name change and there will also be packaging changes. The insulin products will remain the same and so there will be no need for a change of insulin type, dose or regime. These changes will take place over the next 6 months.

The name changes mean that the word 'Human' will be omitted so that for example, what is now 'Human Actrapid' will become simply 'Actrapid'.

The above insulins, as well as Novo Nordisk 3ml Penfill cartridges, will be subject to changes in the packaging and the patient information leaflets.

These changes have been approved by the EU Commission and will apply throughout Europe resulting in the same brand names being available in all European countries.

The names of Novo Nordisk pork insulins will NOT change but it is important to ALWAYS check that you have the correct insulin BEFORE leaving the pharmacy.

The names of Pork Actrapid and Pork Insulatard will NOT change. However, IDDT has concerns that there could be confusion when a prescription for Novo Nordisk pork insulin is dispensed. Not stating the word 'human', or some other alternative such as synthetic or GM, in the name or on the pack, could lead to GM Actrapid or GM Insulatard being dispensed by the pharmacist instead of Pork Actrapid or Pork Insulatard.

We are assured by Novo Nordisk that the new human insulin packs look very different from the pork insulin packs and that there will be a warning on the side of the packs for the first 6 months. This should help to avoid confusion but IDDT issues the following warning:

ALWAYS check that you have the correct insulin BEFORE leaving the pharmacy.

However, IDDT does have concerns that as a result of these changes it will no longer be possible to easily recognise that Novo Nordisk's range of human insulins are actually GM synthetic insulin. Again we are assured by Novo Nordisk that the Patient Information Leaflet for the 'human' insulin range clearly states in bold type in Section 1 that the insulin is human. Yet another reminder:

ALWAYS read the Patient Information Leaflet even if you have been using insulin for years, because this is where any changes will be reported.

We have discussed our concerns with Novo Nordisk and they are going to issue warnings to pharmacists through pharmacy journals and supply fridge magnets to pharmacies. It remains to be seen if this will totally prevent mistakes happening, not just for the next 6 month but indefinitely.

Glitazones are oral drugs for the treatment of Type 2 diabetes and that are insulin sensitisers to enable the body's insulin to work more effectively. The first glitazone, troglitazone [Rezulin], had to be withdrawn from the market when it was suspected of causing 400 deaths from liver failure, but after not until 2 years after the reports were first received after scandal and the threats of whistle-blowing.

Avandia and Actos, from the same family of drugs, were introduced about a year before troglitazone was withdrawn. It was claimed that these drugs did not cause the same problems, later proved not to be entirely correct when warnings of serious liver and cardiac complications appeared.

NICE, the National Institute for Clinical Excellence, first issued guidance on glitazones in March 2001. It recommended that glitazones were effective at reducing blood glucose when added to either metformin or a sulphonylurea but only in people whose blood glucose could not be adequately controlled by one of these drugs on their own [monotherapy]. Now NICE have updated reviewed and changed this guidance as a result of new research.

· The use of a glitazone [Avandia and Actos] added to either metformin or a sulphonylurea as an alternative to treatment with a combination of metformin and a sulphonylurea, is not recommended. The exceptions are for people who are unable to take these two drugs because of intolerance or a contraindication to one of them.

· If glitazone combination therapy is used, then its efffectiveness should be monitored against targets for glycaemic control and for other cardiovascular risk factors, including lipid profiles.

· The combination of metformin and a sulphonylurea should remain the first treatment choice where treatment with one of them on their own has failed to achieve adequate blood glucose control.

· A glitazone should be used in combination with metformin or a sulphonylurea ONLY in people with Type 2 diabetes for whom monotherapy hasn't worked to control blood glucose and cannot take the combination of metformin and a sulphonylurea because it is not suitable for them or they cannot tolerate its side effects.

· The licences for glitazones do not permit the use glitazones as triple therapy ie with the combination of metformin and a sulphonylurea or with insulin.

NICE recommends that if you or someone you care for has Type 2 diabetes, you should discuss this guidance with your doctor.

Further information can be obtained from the NICE website www.nice.org.uk and the full guidance can also be requested by telephoning 0870 1555 455

Avandia - the manufacturer, GlaxoSmithKline [GSK], is facing legal action in the US by 32 people, some of whom claim that they needed liver transplants within weeks of starting the drug. They claim that the company failed to adequately warn patients that Avandia could cause serious cardiac and liver complications and was slow in reacting appropriately with additional warnings once these reports were made known to them. GlaxoSmithKline deny these claims - to be expected when Avandia, used by 3 million people with sales rising last year by 19% to £809 million!

Legal actions continue with troglitazone - in April 2003, a New York jury ordered the manufacturer, Pfizer, to pay $2million damages compensation to a woman who was injured after taking troglitazone. Pfizer is appealing against similar verdicts in other States. Recently a federal appeals court reinstated a $1.4billion [£834million!!!] lawsuit against Pfizer brought by health insurers to recover the amounts they paid for drug and subsequent liver testing between Feb 1997 and April 2001.

In October 2002, we reported that trials of Novo Nordisk’s new insulin sensitiser drug were stopped because bladder tumours were found in mice and rats. In January 2003 Novartis, halted development of their new dual sensitiser drug for the same reason – tumours in mice and rats.

On July 8^th CP Pharmaceuticals announced that it had been acquired by Wockhardt Ltd, a leading Indian pharmaceutical company. This transaction makes CP a subsidiary of Wockhardt.

· With the acquisition of CP Pharmaceuticals, Wockhardt's annual sales in the UK alone touches 50million sterling pounds, making it one of the top 10 generic companies in the UK.

· Wockhardt is one of India's leading phramaceutical companies with sales of 105million sterling pounds. It has 11 manufacturing facilities, three of which are approved by the FDA in the US.

· Very soon it will become the world's fourth manufacturer of recombinant human insulin.

· CP has four key businesses consisting of hospital drugs, generics, contract manufacturing and exports.

· Some of CP products have significant market shares in the UK and these include Hypurin Bovine insulin [100%], Hypurin Porcine insulin [34%].

Naturally concerns have been expressed about the future of the range of Hypurin animal insulins and on July 14^th a press release was issued stating the following:

"CP and Wockhardt would like to confirm that the supply of Hypurin porcine and Hypurin bovine insulin continues unchanged.

CP has been dedicated to the production of natural porcine and bovine insulins for over 30 years and has further invested in the product range with the recent launch of hypurin 3ml cartridges. CP's investment has demonstrated a clear commitment to ensure continued supply of Hypurin insulin for the foreseeable future."

We have been aware for some time that an acquisition of CP was in the pipeline and we welcome the reassurances from Wockhardt and CP that supplies of natural pork and beef insulins will continue.

It is understandable that there are concerns about future availability. While IDDT has always maintained that this is a worry that people should not have to face on top of having to live with diabetes itself, these concerns are not knew to people who are reliant on natural animal insulin for our future health an wellbeing.

It is important to look on the positive side too, who knows it could be that Wockhardt look to expanding the animal insulin business so that more people are aware of the existence and advantages that animal insulins can have for some people.

As part of the acquisition Mr Charles savage will be stepping down as Chief Executive of CP, the good news is that he will remain in a consultancy capacity for two years.

IDDT would like to express our most sincere gratitude to Charles for CP's commitment to the ongoing supplies of natural insulins under his leadership. However, we would also like to thank him for his personal commitment to helping and understanding the people who need animal insulins. This commitment has often extended far beyond the call of duty and is appreciated by people in many different countries.

Wockhardt announced that they are launching a synthetic 'human' insulin in India derived from yeast and is called Wosulin. It is the first synthetic insulin to be manufactured in India as the large multi-national companies have only assembled and packaged in the country. Until now 90% of the Indian insulin market has been for pork and beef insulin prescribed for the Muslim and Hindu communities respectively.

" But medical experts believe that selling the new product to an existing patient will not be easy because switching over to the new insulin might lead to complications."

We must be thankful that the diabetic community in India is being warned by their diabetes experts that there may be complications with the changeover - something that the experts in developed countries failed to do. Perhaps the experts in India have gained from our experiences.

Wockhardt are pricing a 10ml vial of Wosulin at 129Rs [nearly $3] and will be the cheapest insulin on the market. They will also be marketing the insulin globally and this could have implications for people in developing countries who cannot afford the high costs of the insulins produced by Lilly, Novo Nordisk and Aventis.

On a slightly lighter note, the BBC News item headline describes the rDNA insulin as 'vegetarian' insulin. That's a new one!

NICE [National Institute of Clinical Excellence] has now issued guidance on the use of insulin pumps that hopefully will clarify the situation for people wanting to use pump therapy to control their diabetes. Until now there have been variations in whether or not the local NHS will pay part or all of the costs of the pump and the ongoing consumables.

Insulin pump therapy is recommended as an option for people with Type 1 diabetes provided that:

· Multiple dose insulin [MDI] therapy has failed, including the use of insulin glargine [Lantus].

· Those receiving the therapy are willing and able to use the therapy effectively.

· Insulin pump therapy should be provided by a trained specialist team [physician specialising in pump therapy, diabetes nurse and dietician].

· People beginning pump therapy should be provided with training in its use and ongoing support.

· These recommendations for Type 1 diabetes are also valid for children, adolescents, pregnant women and women who are intending to become pregnant. However, because of the risk to the fetus, pregnant women and those intending to become pregnant should only switch to insulin pump therapy under the care of a specialist team.

· Established users of pump therapy should have their insulin management reviewed as they may be suitable for a trial of insulin glargine [Lantus], along-acting insulin like medication.

· Pump therapy is not recommended for people with Type 2 diabetes who require insulin.

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

"This is people for whom it has been impossible to maintain HbA1c level no greater than 7.5% [or 6.5% in the presence of microalbinuria or adverse features of metabolic syndrome] without disabling hypoglycaemia occurring despite a high level of self-care of their diabetes."

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

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

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

NICE has issued guidance on other aspects of diabetes and these can be found by visiting www.nice.org.uk

Cialis - Lilly has introduced this new drug for the treatment of impotence. Its effects last for 24 hours and so the manufacturers say that it will allow men with erectile dysfunction to choose when they want to have sex and will allow couples greater spontaneity. The publicity material says that in clinical trials Cialis worked in four out of five men. Like Viagra it will only be available on the NHS to certain patients.

Vardenafil or Levitra - this is a new drug introduced by Bayer/GlaxoSmithKline for the treatment of impotence. Clinical trials have shown that Bayer/GlaxoSmithKline is effective and reliable in a wide range of men with erectile dysfunction. Among men with diabetes 73% taking 20mg vardenfil showed a significant improvement in erections. Most adverse events were mild to moderate and transient - headache, flushing, rhinitis dyspepsia, nausea and dizziness. Vardenafil is taken orally 25 to 60 minutes before sexual activity and is effective up to nearly 5 hours later.

Viagra was the first impotence drug to be introduced and all three are available on NHS prescription to men with diabetes but this is limited to four tables per month

Lantus is a CLEAR long acting insulin

Insulin glargine, called Lantus by Aventis, is a long acting basal insulin analogue. It is being proclaimed as the first truly long acting insulin. It does seem to have been forgotten that there used to be a truly long acting beef insulin before it was discontinued and this was widely used particularly in people with Type 2 diabetes.

Lantus has been available in the US for some time and in the UK came on the market in August 2002. Initially it received approval for single injection at bedtime but the first changes to its use were made in December 2002, when Lantus received European approval for use in children over the age of 6years and for flexible injection times. [Perhaps an attempt to avoid the early morning hypos?]

The introduction of Lantus is thought to be an important milestone in managing diabetes because it has a smoother action over 24 hours than previous long acting insulins. Much of the research seems to be in people with Type 2 diabetes and it has shown that there is a reduced risk of hypoglycaemia when using glargine [Lantus] as opposed to the usual ‘human’ long acting insulin [isophane/NPH].

At an Aventis sponsored symposium at the annual professional conference of Diabetes UK 2002:

Professor David Owens said that compared to existing long acting insulin [remember research has only compared it to ‘human’ and not animal]:

· it has greater molecular stability [research has only compared it to ‘human’] and this results in a flat action profile compared with an early peak in present longer acting insulin. Thus there is less risk of hypoglycaemia.

· It is well tolerated and at least as effective in as present longer acting insulin.

· It has not been shown to improve HbA1cs but is at least as effective at helping to maintain target HBa1c levels but with less risk of hypoglycaemia. [Does this mean that it has been proven that there are actually less hypos or just less of a risk in theory?]

Unlike all other long acting insulins Lantus is not milky but clear. Diabetes specialist nurse, Ms Jill Hill said at the symposium that this was an advantage because it would not have to be shaken before injections and that this was ‘just one less thing that patients will have to remember to do.’ But practical experience of using this new clear long acting insulin in daily life in the US, is a little different! A letter from physicians in Diabetes Care, Feb 2002, warns that two of their patients that they describe as having ‘excellent compliance’, injected their very rapid short acting Humalog instead of their Lantus [glargine] by mistake. This is an easy mistake to make, especially when tired before going to bed and fortunately both these people realised what they had done and remedial action was taken. Perhaps we would all rather shake the bottle than run this risk.

Aventis obviously were aware of the risk of confusion with the short acting insulins, because Lantus is marketed in a different shaped vial from all other insulin vials – it is longer and thinner and the label is in purple writing.

LANTUS – a mixed response from you!

In our January 2003 Newsletter we gave a cautionary note that this a new insulin and like all new drugs we have to see what happens when used in much larger numbers of people and over a longer time.

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

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

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

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

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

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

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

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

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

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

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

“Lantus is as effective as ‘human’ insulin with respect to glycaemic control but major safety issues were identified - hypoglycaemia, local reactions/toxicity, immunological reactions/antibody formation and ocular safety.”

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

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

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

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

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

The major safety concerns identified by the EMEA

· If people had previously used a regime of injecting their long-acting once a day, then there were less night hypos with Lantus. But if people had previously injected their long-acting insulin twice a day, morning and evening, then there was a greater increase in hypoglycaemia with Lantus even with a 20-25% reduction in dose of Lantus.

· After the initial phase, the frequency of hypos with warnings and the incidence of severe hypos were the same with Lantus and ‘human’ long-acting insulin. BUT there was a higher incidence of hypos without warnings in people using Lantus. The document says that Lantus is as safe as ‘human’ insulin. [wry smile!]

· As there is still some insulin left at the injection site after 24hours, this prolonged exposure of relatively small areas of tissue may result in local toxicity. Careful post marketing surveillance is recommended to monitor the appearance of serious local reactions.

· Direct quote: “The occurrence of injection site Malignant Fibrous Histiocytomas in rats in pre-clinical studies raised concerns as to the carcinogenic potential of Lantus but following careful evaluation of the relevance of these findings, it was concluded that at present the carcinogenic potential is not a point for particular concern. However, in view of the lack of clinical experience following long-term exposure to Lantus careful post-marketing surveillance will be required in order to monitor the appearance of more serious local reactions.”

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

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

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

We also must not forget that the European document did not mention the adverse effect that has been reported to IDDT by several people – joint pains and swellings.

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