The fight to 'save' my life - GM insulin (1/9/2004)

The first article below, while excellent in other ways, does not make clear that the problematic ('human') insulin is genetically engineered.

The second article mostly repeats what's in the first but is of interest for its reference to a hidden "agenda" in the disappearance of animal insulin. No one says what it is, but could it be the fostering of the miserably unsuccessful medical GE industry?

More info on the often severe problems arising from GE insulin:
Bellagio report on human insulin commissioned by Rockefeller Foundation
Also see

The fight to 'save' my life
Exeter Express & Echo
10:23 - 27 August 2004

A city diabetic fears her quality of life will be devastated because the insulin she uses may not be available for much longer.

Shelley Cox thought she was going to die when she had an adverse reaction to a human form of the medication. In less than a year of taking the drug she went from an active, outgoing woman to a virtual bedridden recluse.

She could not tolerate bright lights, struggled with her concentration and memory, and had no energy. Mrs Cox, from Alphington, felt so ill she was convinced she would never feel well again. But then she saw an advert in the Echo promoting animal insulin and realised there was a choice of medication.

Feeling she had nothing to lose she asked to be switched to it - and within 12 hours of taking her first injection she felt she had got her life back. But now she fears the life-changing animal insulin will soon not be available.

One of the two companies which supplies the drug to the UK market has recently sent a letter saying it is in the process of deciding whether to withdraw it.

Danish-based Novo Nordisk sent the letter to a diabetic in Sussex, after he wrote asking about their future plans. The company, which currently supplies about 15,000 of the 30,000 diabetics on animal insulin, said the final decision would not be made until next summer, and if the decision is to withdraw, it will not take place until 2007. The company has already stopped production for America, Canada and some parts of Europe.

Although the other company, CP Pharmaceuticals, which supplies the remaining UK diabetics, said it had no plans to discontinue its supply - it cannot produce enough for all the Novo Nordisk users.

Mrs Cox and her husband, Peter, the Conservative parliamentary candidate for Exeter, are calling on the Government to help safeguard the supply of animal insulin. And they are backed by the shadow health minister, Tim Loughton.

Mrs Cox, who was diagnosed with type one diabetes in January 2003, said she could not face going back on the crippling human insulin, or having to try out one of the new breeds of analogue insulin, produced by genetic engineering.

"Even if going back on human insulin keeps me alive, given the quality of life for me, I would rather not be alive," she said.

The effect was also traumatic for her husband. Mr Cox said: "I was terrified. I thought she was dying.

"I was watching my wife and my world slowly disintegrate and there was nothing I could do about it, except be there for Shelley and put on a brave face. Total despair is the only way to describe it. Anyone who has lived through the illness of a loved one will understand what I mean. The feeling of helplessness was the worst part. Nobody seemed able to shed any light on what was wrong, that is until I saw the advert for the animal insulin and my despair turned to intense relief, then anger."

He added: "Having gone from the pits of despair to relief, to being on top of the world, we are now finding out that the animal insulin might not be available. It's almost worse than it was before."

The couple's nightmare began in September last year, when, just nine months after being diagnosed, Mrs Cox began to feel constantly tired and lethargic.

Over the next six months her condition steadily worsened. She developed a strong dislike of bright lights, and had to wear sun glasses or keep the curtains shut at home.

She gave up driving because of her poor concentration - which was so bad she would forget what she was saying mid sentence.

She was too ill to work and underwent tests for everything from rheumatoid arthritis, to ME. Eventually she was virtually bedridden.

Getting out of bed and getting dressed left her feeling as though she had just run a half-marathon, she said.

"I just fell so ill all the time," she said. "I had never felt so ill. I couldn't think, everything was cloudy. I genuinely thought I had cancer or a tumour. It was the worst nightmare I have ever been through. And not knowing what was causing it just made it worse."

She said she was so relieved when she found out it was her reaction to the insulin which caused her all the problems.

"I thought 'Thank God I am not going mad.'" she said.

Mrs Cox was put on animal insulin in April and, within 12 hours felt more energetic than she had for months. Mr Cox said: "Her first injection was in the evening, and the very next morning we went to the garden centre - something we had not done for months. The day after that we took the dogs to the beach and on the third day we rode our horses together.

"The change was remarkable and almost immediate."
Mrs Cox added: "I felt so much better. I felt as if I had got my life back."

The couple have since reported their experiences to the diabetic clinic at the RD &E, and asked staff to log her reaction.

Jenny Hirst, from the Insulin Dependent Diabetes Trust, which actively promotes animal insulin as an alternative to the human form, said: "It's bad enough having diabetes, but to live in fear that you may not have the medicine to keep you feeling alright, I think is beyond reason."

Like many new diabetics, Mrs Cox was not told about the animal insulin and put straight on the human form. However, she had no problem accessing it at the diabetic clinic when she asked to try it.

Only three out of about 800 people treated at the clinic are on animal insulin, and Mrs Cox's reaction is regarded as highly unusual.

But she would like all new diabetics to be told there is a choice of insulin to take - and to have that, a continued supply of the animal insulin needs to be guaranteed.

The medical director at Novo Nordisk, Dr Alan McDougall, told the Echo that they hadn't yet taken any decision on supplies that would affect the UK. But he added: "We can never given any guarantee. We are aware that there are many people in the UK that use Novo Nordisk animal products."

He said when the company makes a decision it will make sure that everyone has at least 18 months' notice. He added: "We will make sure there is a solution for everybody. It may be the new analogue insulin."

Mr McDougall refused to comment on how much it cost his company to manufacture animal insulin as compared with human insulin, saying that was 'commercially sensitive.'

He did say, however, that in the UK, it works out cheaper to supply animal insulin than human insulin.
A spokeswoman for the Department of Health said they were not aware of any problems with the supply of animal insulin.

"There are two companies supplying it in the United Kingdom," she said.

"We are in regular contact with these companies and both have confirmed that they will continue to supply animal insulin for the foreseeable future."

She pointed to the Government's committee on safety of medicines (CMS), which has concluded that although some patients experienced problems on transferring to human insulin and were better suited to animal-derived insulin, there was no evidence of a safety concern specific to human insulin.

And she said they had no powers to force a company to continue to market a product if, for any reason, it is unable to do so.

Exeter Express and Echo
12:00 - 28 August 2004

A leading politician is taking up the case of a Devon diabetic who fears her life is as good as over if the type of insulin she needs is withdrawn.

As the Echo reported yesterday, Shelley Cox thought she was going to die when she had an severe adverse reaction to a human form of the medication.

Within a year of first taking the drug she went from an active, outgoing woman to a virtually bedridden recluse. But within 12 hours of switching to animal insulin she was back to her old self again.

But now she is concerned that the life-changing insulin will soon be unavailable after hearing one of the companies which supplies it, is considering stopping.

Mrs Cox, whose husband Peter is the Tory parliamentary candidate for Exeter, is calling on the Government to help safeguard future supplies of the insulin for the 30,000 diabetics across the UK.

And she is being backed by shadow health minister Tim Loughton, who has promised to take up her case with health minister Rosie Winterton.

When Mrs Cox's health deteriorated she had no idea it was because of a severe reaction to the human insulin she was using.

She had been diagnosed as diabetic in January 2003 and at that time was not aware there were different types of insulin.

It was only after seeing an advert in the Echo by the Insulin Dependent Diabetes Trust (IDDT) that she found out about the animal insulin.

The charity works to promote animal insulin and also lobbies to safeguard its future.

Mrs Cox was able to change over to this insulin easily at Exeter's diabetic clinic, which is based at the Royal Devon & Exeter Hospital - and the improvement in her health was immediate.

But now she has discovered that the Danish company Novo Nordisk, one of two drug companies which supplies animal insulin in the UK, has said it may stop producing it. It has already stopped production in the US, Canada and parts of Europe.

The final decision is due to be made next year, and production could stop in 2007. If it does, it could leave around 15,000 people across the UK without their preferred medication. Although the other company, CP Pharmaceuticals, said it had no plans to discontinue production it cannot produce enough for all the Novo Nordisk users.

Mr and Mrs Cox, along with the chairman of the IDDT, Jenny Hirst, met with Mr Loughton in London to discuss their fears. He had already been contacted by the charity and other diabetics, and, on their behalf, had contacted the Department of Health.

He was told then that they were not aware of a problem with the supply of animal insulin. Officers were in regular contact with the two companies that supply the insulin to the UK and both had confirmed they would be supplying it 'for the foreseeable future'.

But after hearing the full details of what happened to Mrs Cox, and just how crippling an adverse reaction to the human insulin can be, Mr Loughton is set to take her case to the health minister.

He has letters from her husband highlighting just how bad her condition got. Mr Cox told him how she was so tired and in so much pain that she could not get out of bed.

"I was terrified - I thought she was dying," he said. "I was watching my wife and my world slowly disintegrate and there was nothing I could do about it. Total despair is the only way to describe it."

And Mrs Cox said she had felt so bad on the human insulin, that she could not contemplate going back on it.

"Even if going back on human insulin keeps me alive, given the quality of life for me on human insulin, I would rather not be alive," she added.

Mr Loughton will present Mrs Cox's case and ask the health minister for details of the safeguards the Government has put in place to ensure animal insulin continues to be made available to everyone who demands it.

He has also backed Mrs Cox's call for better education for diabetics so they can choose from the full range of insulin products.

This is especially important as the numbers of people expected to be diagnosed with the disease across the world over the next three years is set to increase from two to three million.

Mr Loughton said the Government could not tell a company what drugs it should produce. However, there were things it could do to ensure the production of animal insulin.

He pointed to the Government's decision in 2002 to buy an American blood plasma supply company for about GBP50m, to prevent the threat of variant Creutzfeldt-Jakob Disease (vCJD), a brain-wasting disease, being spread through blood products. Mr Loughton is also trying to find out why Novo Nordisk is now considering stopping its supply.

The company's medical director, Dr Alan McDougall, has already said that in the UK, it works out cheaper to supply animal insulin than human insulin.

"If it was a cost factor that animal insulin cost five times more than human insulin, we could see why they might want to do it," said Mr Loughton.

"But there's no reason why. It's bizarre. There's some other agenda there which I don't fully understand," he added.

The national charity Diabetes UK has its own opinion as to why the company is currently reconsidering its supply.

A spokeswoman said: "A decline in usage is likely to be the reason Novo Nordisk will be looking at the possibility of withdrawing its animal insulin range."

The human insulin has only been introduced in the last few decades and it is the one most new diabetics are prescribed.

Diabetes UK believes more could be done to make doctors and patients aware of the other insulin available.

"If people with diabetes are struggling to control their condition with one particular insulin they should be aware of the range of options available to them, including animal insulin," said the spokesman.

"We'd much rather Novo Nordisk continued to produce animal insulin and this is the position we continue to put to them. The more choice for people with diabetes the better."

But Mr Cox believes the company is taking advantage of the fact many patients do not know about the choice of animal insulin. He said: "The time will come when demand for animal insulin has gone down and the company can say that it's not commercially viable."

This is a view shared by the IDDT, which is also concerned that the vast majority of diabetics are only offered human insulin and are not told about the animal variety. By not offering an alternative, fewer patients will request animal insulin, the demand for it will fall, and the company can then justify its withdrawal, it says.

Dr Mark Daly, a leading expert in the condition, based at Exeter's diabetic clinic, said there was no particular advantage to animal insulin.

"But there are patients who report that they feel better on animal insulin and if they feel they would like to try animal insulin, I feel they should have that choice," he said. A number of former animal insulin users had successfully switched to human insulin, he added.

Patients, he confirmed, were not given the choice of going on animal insulin, when first diagnosed. However, they were given animal insulin if they subsequently asked for it.

Dr Daly added: "It's a worry and distressing for people to change insulin. If they trust and have faith in an insulin and have to change it, it can be very distressing."

He said only three out of 800 people at the clinic are on animal insulin and that a reaction as bad as Mrs Cox's to human insulin is highly unusual. The choice of insulin can also be governed by which type of injection pen the patient prefers as some versions of the drug are only compatible with a certain type of pen.

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