As many of you will, unfortunately, know, Alzheimer's is a dreadful disease, which robs sufferers of their memory and eventually strips them of their dignity.
Today I have a small interview in the Daily Mail. It is with a wonderful woman called Mary Stevenson whose husband, John, was diagnosed with Alzheimer's when he was only 53. Mary is a strong, intelligent woman whose life has been changed irrevocably by the disease John is suffering from. Obviously John's life has been changed too. As Mary says, he is no longer the intelligent, witty businessman that he once was.
Please read my piece in the Mail, although you'll have to be quick because it doesn't appear to be online!
However, if you are interested in some of the other current issues around Alzheimer's, take a look at my very long article below. It tells you more about Mary and John, but is written mainly because of the recent decision by the National Institute of Clinical Excellence to restrict the drugs that help Alzheimer's sufferers.
Mary Stevenson is angry. She cannot believe a drug that has helped her beloved husband John so much will now be denied to people just like him, who suffer from Alzheimer's.
“I hate to think what life would have been like if he hadn’t been on Aricept,” says Mary. “I don’t think I could have coped. To withdraw these drugs is absolutely stupid and awful, and I’m sure it’s only because it’s the older generation who get the disease. The drugs only cost £2.50 a day. Aren’t people like John worth that?”
Aricept is one of three medications known as acetylcholinesterase inhibitors that are used to treat the symptoms of Alzheimer’s disease – a physical disease that affects the brain. It is progressive, and has no cure – cells die off over time, and the brain becomes increasingly damaged. No one is quite sure why it happens, but the greatest risk factor is age (one in five 80-year-olds will be affected by the disease). Around 400,000 people in the UK are currently affected, but this is set to increase rapidly in the future as the population ages.
The illness begins gradually. Sufferers may notice problems with their short-term memory, for example, and then as the disease progresses, usually over a period of years, become prey to more marked changes. They may forget names and faces and need help to eat, dress and wash. In the final stages, sufferers need to be looked after 24 hours a day, often away from the loved ones they can no longer remember - and in hospital or care homes. Alzheimer’s starts by stripping people of their memory, but goes onto strip them of their dignity.
John was prescribed the drug seven years ago, around nine months after being diagnosed. The diagnosis came as a dreadful shock. “Nobody knows what they're going to have to face in life, but it was devastating to be told this when John was only 53,” says Mary, 63. “What we could cling to, however, was the fact that there was something that could help him and stop him deteriorating so quickly. Everybody knows there isn’t a cure for Alzheimer’s, but you can still have a quality of life. Aricept has given us so much more time together.
“Over the past seven years, John has given away three of his daughters at their weddings, and made speeches at them too. Before he took the drug, he was so confused that he couldn’t remember his figures, and had no idea about the difference between a 10p piece and a £10 note. He was still working as a chartered surveyor, but unpaid bills were mounting up. He would look at cheque books and not know what to do with them, or put a CD rom in the wrong place on the computer. He'd forget names, or say the wrong thing in meetings. His mind couldn't explain what he wanted to say; he was losing it. He'd think Tuesday was Thursday, or Wednesday was Friday, repeat what you said, and get his facts confused.
"We didn't tell the children what was wrong until we had the diagnosis, but they told me afterwards that they thought he had a brain tumour because he was acting so strangely.
"Aricept enabled things to return almost to normal for a while, although he still wasn't brilliant with figures, so I took over the bills. He was able to keep working for another 18 months and, since then he's seen our youngest daughter, Rebecca, through sixth form and university, and gained so much pleasure from our three young grandchildren. I honestly don't think we'd have had that much time together without the drug.
“When we were first told that John might have Alzheimer's, I found out more about it and couldn’t believe it. The more I looked into it, the worse it seemed. It's the kind of thing you just can't imagine happening to you, and John and I discussed it - we could talk about things then. I remember, he said 'I promise you, I won't let it get that bad,' and I said 'but you don't have control over it.'
“Without Aricept, I think John would have slowed down so quickly, although nobody can say for certain how bad he would have been without the drug. It made an immediate difference when he started taking it, and I am convinced it has held off the disease more recently. I think it has meant he has deteriorated more slowly.
“John was a clever, witty, intelligent business man, but last week we were told that he is now in the moderate to severe moderate stages of the disease, and getting worse. Being told that was very emotional, and I admit that I have cried a lot. Life is very stressful, and without the tremendous support from our family, I would have gone under ages ago. But the children live all over the country, and I've got no back-up here, where we live, in a small village in the Lake District.
"John can no longer write now – his brain can’t tell his hand what to do – and he’s finding it hard to read too. He can’t make himself a cup of tea, and on a bad day he can be very uncooperative - for example, he will let me put shampoo in his hair to wash it, but he won't then let me wash it out again. He also fidgets a lot, folds things up, or cuts bits out of the newspaper, so that when I go in the room, there are pieces of paper all over the floor.
“Still, we’re trying to make the most of the time we’ve got. I still love John, no matter what, but it’s different - he’s not the same person. He was always so dynamic, but now it's like role reversal. I have to make all the decisions, from what to we do each day to what we eat. He was so go-ahead, and now he's closing down. But sometimes, his wit comes back, and he makes a great, dry comment.
“I do get very weepy, although I don't think you can wallow in self-pity. But I do wonder what the future holds for me, and think that it's not a lot. When we met we already both had children, and then had Rebecca together, so we never really had time for just the two of us. The children are wonderful, so we don't regret that at all, but because of the Alzheimer's we now don't have time together when we thought we would - once the children left home. Still, we try to keep busy. If I couldn't get out and do things, life would be unbearable. We have lots of friends in the village, belong to the Rotary Club, and I belong to the WI as well. But it's still lonely. My best friend is gone, and he's not coming back. Yet I’m sure he would have reached this stage far sooner without Aricept.”
John is one of the lucky ones. Last November, it was announced that people like him will now no longer be prescribed drugs like Aricept – and so gain valuable time with their loved ones - when they are first diagnosed. The National Institute for Health and Clinical Excellence (NICE), which was set up to advise the NHS on how to best spend its money on drugs, ruled that treatment with the three acetylcholinesterase inhibitors, donepezil (Aricept), galantamine (Reminyl) and rivastigmine (Exelon) should be restricted to people in the 'moderate' stages (as opposed to the earlier, 'mild' stages or the later 'severe' stages) of the disease, and stopped when patients enter the later phase. In addition, it ruled that memantine (Ebixa), which is the only drug treatment licensed to deal with behavioural symptoms in the severe stage of the disease, could no longer be prescribed at all – unless it was for a clinical trial. This has also been greeted with dismay, as Ebixa can reduce symptoms such as aggression and agitation in Alzheimer's sufferers. The only alternative way to treat these symptoms is with antipsychotic sedatives called neuroleptics which are not recommended for people with dementia.
Now the Alzheimer’s Society has said that it is going to go to the High Court to force NICE to explain how the decision to restrict the Alzheimer's drugs was reached – and to make them reverse it. It’s the first time that NICE has been challenged in this way.
The companies that make the Alzheimer’s drugs are also involved. But Neil Hunt, chief executive of the Alzheimer’s Society, says their challenge has a different motive.
“It makes sense for us to be part of the same judicial review, but we are completely on our own,” he says. “We’re not interested in who's making money, we’re interested in whether these drugs are available or not. We think they should be.”
The NICE ruling – which allows those already on the drugs to keep getting them - did not surprise many experts, as it upheld an earlier decision announced in March 2005. The drugs appear to be relatively cheap, but the Alzheimer’s Society and others are convinced that the decision was taken on cost grounds alone as NICE did conclude that the drugs were clinically effective. NICE rejected appeals from patient, carer and professional
groups, as well as the drug manufacturers, and says that for many patients there is "no benefit" from taking the drugs, and that it doesn't want to give them or their carers "false hope."
"We have a responsibility to help the NHS spend its money wisely," said a spokeswoman. "It is far better to treat patients for whom the drugs have the greatest benefit, and evidence has shown that these are patients with moderate Alzheimer's disease."
Roy Jones, director of the Research Institute for the Care of the Elderly in Bath, and a professor of gerontology, the study of ageing, was one of those who gave evidence to the appeals committee. He can’t understand how it upheld the earlier verdict.
“We are now being told to diagnose people with mild Alzheimer’s but then tell them that we can’t give them drugs - so they should come back when they’ve deteriorated, then we can try to improve their symptoms again.
“This is a very unusual concept. No one says to someone with mild diabetes,
we’ll treat you when you’re worse. It puts doctors into difficulties to have
to say this to patients. It’s a real ethical dilemma.”
Professor Jones is curious about the model that NICE used to determine the cost effectiveness of the drug in the different stages of the disease (this will also be one of the drug manufacturers’ main bones of contention in the judicial review). The decision was dependent on a complicated model that uses a measurement called a “quality adjusted life year”, but Alzheimer's experts say that it isn't clear exactly how this has all been worked out.
Professor Jones is particularly concerned that the calculations don’t fully take account of how the drugs may enable patients to be looked after at home, rather than in expensive care, for much longer. Nor does he think the organisation properly considered the positive effects the drugs have on carers. “Carers who are stressed use their own doctors more for problems such as anxiety and depression caused by dealing with the day to say difficulties of looking after someone with the disease," he says. “That’s part of the overall cost of Alzheimer’s to society.
"The evidence that these drugs work in mild Alzheimer’s is undoubted and NICE accepts that, but they used a particular model to work out cost-efficiency, and our advice was ignored. It looks as if we are going back to the situation we used to have – when getting the drugs you need depends on whether you can afford it.”
According to the Alzheimer's Society, the benefits of the drug treatments for people with Alzheimer's disease in both the mild and moderate stages are evident from the results of more than 30 placebo controlled trials which were evaluated as part of the Cochrane Collaboration, the leading body for undertaking systematic reviews of treatments. The research also suggested that people who began drug treatment at a later stage never caught up with those who began earlier. This implies that earlier treatment leads to an improved long-term prognosis.
Dr David Wilkinson, a psychiatrist and founder of the Memory Assessment and Research Centre, at Moorgreen Hospital in Southampton, agrees.
“Everybody involved in the use of these drugs knows they work,” he says. “I gave evidence to the committee on this, but they didn’t want to hear it. Yet the data from analyses of clinical trials shows that the key to getting the most benefits from these drugs is to start patients off on them early, and for them to be used continuously.”
“I’ve been working in this field for 25 years,” says Dr Wilkinson, who describes the NICE decision as a “betrayal” of patients and their families, and considers it “ageist”. “Treatments have got so much better – we simply don’t see the decline we used to, as the drugs change the course of the disease, slowing its progression down. But what we’re doing now is turning the clock back. The decision on Memantine means doctors can only
give people tranquilisers to calm them down in the later stages, when they get agitated, while the ruling on the other drugs suggests that if we diagnose patients early, we then do nothing to help. That’s wrong. We’ve got an ageing population, and it’s absolutely crucial that we make sure people remain independent for longer.”
Dr Wilkinson says that one of the main problems with the decision is its rigidity about determining who is or isn’t eligible for the drugs. The NICE ruling relies heavily on a patient's mini mental state examination (MMSE) score. This examination - a series of questions and tests covering topics such as memory, language, writing and orientation – was originally designed as a screening tool for dementia. It does not enable doctors to diagnose or rule out the disease, but to enables them to decide whom they should further investigate. However, NICE uses it to measure how severe the disease is, stating that only people with a score of between 10 and 20 (out of 30) will have access to the main three drugs. However, patients with a MMSE of 20 may already be having major difficulties with memory and managing everyday activities.
There is no common sense here, and it is not good medicine to take decisions which aren't on an individual basis,” says Dr Wilkinson. “We know that these drugs work in ways that this test can’t measure - on behaviour, mood and sleep - and we have data that was not available in the early trials, but has been clearly seen in more recent studies, which shows that these important aspects of the disease treatment were ignored."
Experts also argue that there are other problems with using the MMSE test so strictly. Scores can differ from day to day. For example, those with a high level of education may score highly, even if they are in the moderate rather than mild stage of the disease.
“For years, people have tried to practise for these tests to achieve the best score they can and reassure themselves that they are not deteriorating,” says Hunt. “In the future, perhaps they will deliberately try to forget things, so that they can get the drugs.”
There is ongoing research into the field of drug treatments, vaccines and blood tests to diagnose Alzheimer’s disease. However, at present, the four drugs subject to the NICE ruling are the only treatments available – around 60,000 people are currently taking them.
Research has shown that there is not enough of a chemical called acetylcholine – used for memory and communication - being produced in the brains of people with Alzheimer's disease. Acetylcholine is broken down by an enzyme called acetylcholinesterase, and this damages communication between cells. Three of the drugs, the acetylcholinesterase inhibitors Aricept, Reminyl and Exelon, work in similar ways to prevent this enzyme from breaking down the acetylcholine in the brain, while Ebixa works by blocking a messenger chemical that damages brain cells, known as a neurotransmitter glutamate.
“The drugs are very effective,” says Dr Wilkinson. “I would probably resign first before telling a patient that they had Alzheimer’s but couldn’t have these drugs.”
The guidelines issued by NICE are not mandatory, but if local primary care trusts - which take control of local health care - do follow them, no budget will be provided for doctors to prescribe these drugs as they wish. “We’re told that clinical judgment is up to the doctor, but if we decide to prescribe them, then we’ll be overspending and something else will be taken away from our budgets,” says Dr Wilkinson.
Back in 2001 NICE recommended that the three drugs (Ebixa wasn’t then licensed) for treating Alzheimer’s disease should be made available on the NHS. The Health Minister at the time, John Hutton, said the announcement represented “a step forward in the treatment of Alzheimer’s disease” and that it would make a “real difference to the lives of tens of thousands of people". With the more recent costing appraisal that, of course, has
changed. NICE has also since claimed that the drugs are not effective for everyone.
“It’s true that not everybody benefits from the drugs, but that’s not an acceptable reason for denying them to people for whom they do make a big difference,” says Mr Hunt. “Our research, which NICE accepts, suggests that around 50 per cent of people benefit, while those who don’t simply stop taking them.
“The question is how to make sure people are not unnecessarily prescribed them, rather than to prevent everybody in the mild or severe stages of the disease from getting them.”
Andrew Dillon, NICE's chief executive, has said that he is “disappointed” to hear of the judicial review proceedings, and that any court action would “divert energy and funding” from NICE’s work.
“Health service funding is limited, and it is our job to assess the clinical and cost-effectiveness of both drug and non-drug interventions to ensure the money spent by the NHS is well spent.
“Our consultation, decision-making and appeals processes are transparent and fair. We share our methodology and enable our stakeholders to see the basis on which our experts arrive at their decisions. We invite patients, medical professionals and anyone who has an interest to express their views and comment on our proposals.”
“I’d be interested to know what someone on the committee would do if a member of their family got mild Alzheimer’s,' says Prof Jones. If it was someone in my family, I wouldn’t want to wait until they got worse before they received the drugs.”
Mary says she’s sure that without Aricept, John’s care would be costing a lot more, while the couple’s quality of life would be far poorer.
“Although John is now worse than he was, and deteriorating all the time, I still believe the drugs are holding the disease back,” she says. “If he hadn’t taken them, he’d have deteriorated so quickly and he might be in a care home now.
”I was 33 when my first husband, David Legge, died of cancer, leaving me with two young daughters. That was in 1977, but back then, David, who was also 33, was given
every drug he needed. Now we’re in 2007, and if John was to be diagnosed now, instead of seven years ago, he wouldn’t be able to get the drugs he needs. That’s age discrimination, and also discrimination against Alzheimer's as a disease, because drugs are available for other illnesses. I can’t believe it’s happening today.”
Meanwhile, John says that people must have access to the drugs. “I’m a person who never wants to give up and I do want to keep going,” he says, “It’s the Aricept that has allowed me to do that. If I didn’t have it, I’d be lost.”
To donate to the Alzheimer's Society appeal, log onto: www.alzheimers.org.uk/emergencyappeal or ring the donation hotline on 0845
John and Mary Stevenson's daughter, Rebecca, is running the NY Marathon in aid of the Alzheimer's Society. Please sponsor her at http://www.justgiving.com/rstevenson .