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Volume 447: debated on Tuesday 13 June 2006

I am grateful for the opportunity to have an Adjournment debate on this topic. This debate is timely in a number of ways, given the decision by the National Institute for Health and Clinical Excellence that was announced a couple of weeks ago and the fact that this week is national carers week.

Many of those on the front line of dealing with dementia are not the individual sufferers, but those affected by the ripples that it sends out through the family and those who take on the role of informal carers, the consequences of which can be huge in terms of stress and its health consequences. I want to cover two or three issues in this short debate, not least the decisions by NICE, and try to tease out where the Government think we should go from here.

It is about 100 years since Alois Alzheimer first described the disease that today bears his name, at a medical conference in Germany. One hundred years on, there is still no cure and our understanding of the basic biological processes behind dementia remains limited. Dementia affects about one person in 20 over 65 and one person in five over 80. There are estimated to be about 750,000 people in the UK with dementia, and that figure is set to rise to more than 1.8 million people by 2050. There is debate to be had about the veracity of those figures, and there is perhaps more to be done to ensure that we are clear on what the epidemiological data tell us and what the trends really are. However, those figures are generally accepted and they demonstrate that there is a significant and growing financial burden as a result of dementia.

That burden is three times more than that of any other of the major diseases—cancer, stroke and heart disease—put together. That is why dementia is one of the greatest health and social care challenges of the 21st century. It is rated by the public as second only to cancer as the disease of which they are most afraid. There is a taboo about dementia and a fear about losing one’s independence and becoming debilitated, at the root of which is perhaps the fact that there is no cure. Recent events have done little to change that perception and have perhaps even fuelled that fear further.

NICE’s recent decision to restrict or even ban certain Alzheimer’s drugs has come as a blow to patients, carers and clinicians alike. Before exploring that decision, however, I should like to pose some questions about research. The basic science behind dementia is still in its infancy. Investment in essential research has not been made and many in the field of medical research believe that research on Alzheimer’s and dementia is about 20 years behind where it could have been if it had received adequate funding.

Research on treatment and cures for Alzheimer’s receives far less funding than such research for other diseases. As of 2001, research on Alzheimer’s received just £3.7 million of Government research funding, as compared with £33 million for cancer research, and the most recent figures suggest a widening of the gap in research spend. For every £11 spent per Alzheimer’s patient on UK research annually, £289 is spent per cancer patient. I want to make it clear, however, that I am not questioning the investment that has been made in cancer research; I merely point to the unevenness of the research effort.

The hon. Gentleman makes his point well. Does he agree that one of the effects of the relative underfunding of research into Alzheimer’s is that a burden that would otherwise fall on the taxpayer is placed on carers, often spouses, who are put under enormous pressure as a result?

The hon. Gentleman has taken a close interest in such issues for a considerable time and I share his analysis. Costs are shunted away from the formal care system in the health service—that might be accelerated as a consequence of NICE’s decisions—and on to individuals. The costs become hidden, but the consequences return to haunt us in the public domain, because they lead to increased health care costs for those who have taken on the caring burden. The saving is therefore illusory, not real. If a disease costs as much as dementia does, it is common sense to commit more research to find ways of preventing and curing it.

The establishment of the dementias and neurodegenerative disease research network has of course helped to provide much-needed infrastructure and follows the template that has been used for developing cancer research. However, there is a still a need for more fundamental research, because without a better understanding of the basic science behind dementia, the potential of the network is reduced. As one researcher put it to me recently:

“Funding the network is like funding the stage in a theatre, but for dementia we need many more players to put on the show to do the research.”

If Alzheimer’s is a Cinderella in the research world, non-Alzheimer’s dementias are like Cinderella’s poor relations. For example, the Medical Research Council is funding only one clinical trial in dementia and no trials investigating the treatment of non-Alzheimer’s dementias. Even basic treatment questions regarding the use of aspirin or anti-hypertensive treatments in people with vascular dementia, for instance, remain unanswered.

It is not just in research that the Cinderella status comes to the fore. The treatment of dementia was dealt a heavy blow two weeks ago, when NICE published its guidance on Alzheimer’s drugs. Not surprisingly, the decision has provoked a huge outcry from patients and carers groups, clinicians and hon. Members from all parts of the House. Placing strict conditions on when the dementia drugs can be used will have a hugely detrimental effect on patients, families, carers and health care professionals. Having issued positive guidance in 2001, NICE has changed its mind, leaving people with mild Alzheimer’s in limbo, condemned to deteriorate before there is any hope of receiving treatment.

The three anticholinesterase drugs—I will give their proprietary names—Aricept, Exelon and Reminyl, are to be made available only to those who attain a mini-mental state examination score of between 10 and 20 for cognitive ability. The test is a key part of NICE’s recommendations for future access to the drugs, but it is fundamentally flawed. It is based on language skills, but many seniors who begin to experience dementia are from ethnic minority populations and their first language is not English. They revert to their first language in dementia and cannot access the test or demonstrate where they are on the scoring system, so they are discriminated against. People are also discriminated against by the tests according to their level of education.

The test should not be the sole determinant of access to the drugs. There was sufficient recognition in the 2001 guidance of an area of judgment and doubt about such tests, which were regarded as a starting point for determining whether the drugs would be beneficial for those with that sort of dementia, not a finishing point. However, NICE appears to have said, “This is the narrow gateway through which you must pass.” In discussions with clinicians, however, the point has been made to me that the scale is too crude to capture the complexity of the disease accurately and to understand the fine lines to be drawn between mild and moderate dementia. As a consequence, we shall be consigning to ever-growing deterioration many who could benefit from the drugs and should be receiving them.

The hon. Gentleman is being extremely generous in giving way. Does he think that NICE has taken sufficient account of the needs of carers in making its evaluation? In other words, although a drug might have a relatively mild therapeutic impact in the early stages of dementia, its impact in giving respite to hard-pressed carers, who are often elderly themselves, is nevertheless considerable. Does he think that NICE has taken sufficient account of that?

No, I do not. However, the hon. Gentleman should not take just my word for that—numerous patient groups and clinician groups have made the same point. Indeed, I understand that the NICE dementia guidelines group and its chairman wrote to the appraisal committee, urging it to retain a wider, more generous set of appraisal guidelines for the use of those drugs. However, that seems to have been flatly ignored. The guidelines group, which is still charged with delivering guidelines for the treatment and management of dementia, includes in its membership social workers, patients, carers and health care professionals—in other words, the people who have hands-on, direct experience and can therefore bring a more rounded perspective to such decisions—yet the appraisal group seems to have set that completely to one side.

It seems to me to be another weakness in the process that although in NICE the voices of patients are now heard at the table, they are not at the right table and therefore cannot exercise the influence that they should. I hope that the Minister will say a little about that and tell us whether he will look again at whether NICE has adequate arrangements in place to ensure that the patient voice and experience and the carer’s view are adequately taken into account.

I want to ask the Minister about another of my concerns about the NICE appraisal. Why has NICE’s appraisal committee not properly considered, as the Department and the Welsh Assembly asked, the cost-effectiveness of the Memantine drug in treating behavioural symptoms of dementia?

One of my concerns about the series of changes that will flow from the decision if it is not overturned on appeal is that we will start moving back to old patterns of organising to deal with dementia. I remember that when I was first elected to the House in 1997 the level of diagnosis was relatively low. There was diagnostic denial. People were not diagnosed early enough: why diagnose when there is no treatment to be given?

Things have changed. We have seen a whole generation of memory clinics and other services develop to cater for the fact that the drugs exist, and in turn those clinics have led to the development of a host of other services and support arrangements, which are of huge benefit. The concern is that the whole infrastructure is at risk because of the decisions that NICE has made. That is why it is imperative that the Minister should be as clear as he can be today about what the next steps are to address the concerns that many of my constituents and others have about where we find ourselves as a result of NICE’s decision.

It is hard to understand how NICE came to the decision, because 30 clinical trials showed the drugs to be effective, offering patients improved memory, the ability to continue to do normal activities, such as washing and eating, and therefore greater independence. That is a key part of the Government’s agenda—a part that I fully support. The benefits extend to carers, who often report being less stressed and happier while their loved ones are being prescribed the drugs.

There are four other reasons why NICE’s decision is wrong, three of which relate to clinical practice. First, it contradicts the purpose of treatment, which is to prolong the early stages or to postpone the onset of the later stages of dementia—to lengthen normality, thus increasing the patient’s quality of life. Secondly, the decision directly conflicts with the Government’s policy to promote the independence of people of all ages. Undoubtedly, the restriction on the three drugs will curtail patients’ ability to think and act for themselves, thus reducing their quality of life and independence.

The point about quality of life is key. Even the chairman of NICE, Professor Rawlins, in an article in the British Medical Journal in 2004, acknowledged that QALY—the quality adjusted life year—should not be the only basis for making such decisions, yet it appears that that has been the case on this occasion. There is a dearth of quality-of-life data, which need to be taken into account when it comes to such assessments. Will the Minister look carefully at whether NICE has taken on board what its own chairman has said on the record?

The third reason why the decision is wrong is that withdrawing access to drugs in the early stages discourages early diagnosis, and the last and perhaps most damaging reason is the ethical conundrum in which it places doctors. Doctors will be forced to wait for their patients to deteriorate before being allowed to prescribe drugs that they know can help. In no other circumstance of which I am aware would doctors be placed in the position of knowing that something that is beneficial could be prescribed, but finding that their hands are tied and that they are told that they cannot prescribe it. One carer says:

“If people could continue to get drugs in the early stages of their disease, the early stages would simply be prolonged. This is better for everyone…mentally, emotionally and physically. Trust me.”

What of later-stage, more severe dementia, when a patient needs treatment most? Did NICE allow Ebixa, a drug that can help a patient when the behavioural symptoms are at their most distressing? No. The only option for doctors will be to fall back on anti-psychotic medication to manage challenging behaviour, in effect placing a chemical straitjacket on seriously ill people. The decision to prohibit Ebixa will not only adversely affect patients, but have huge repercussions for carers. Carers will be placed under increasing strain of the sort that I have described.

Will the Minister make clear what he and his Department intend to do next? Will they support the appeal that has now been lodged? At what point does the Minister have to satisfy himself that NICE is properly discharging its statutory duty and accounting to him and, indeed, to the House for the way in which it discharges that duty?

I accept that drug treatments are not the be-all and end-all of treatment for Alzheimer’s and dementia. However, drug treatments have been a catalyst for other treatments of the disease. As I said, the development of memory clinics has been accelerated by the availability of drug treatments, and a range of other support services have been provided as a consequence. I hope that the Minister will take this point on board. It might be argued that NICE is saving the NHS money through its decision and that cost-effectiveness is part of its remit. Of course cost-effectiveness is important, but it must be stressed that Alzheimer’s treatments are not expensive. On average, the cost is £2.50 per patient per day, or £800 per patient per year. How can NICE maintain clinical excellence if it is asking doctors to ignore a diagnosis until it is sufficiently bad before a drug can be prescribed?

The treatment of dementia has a large impact on the care of people with the disease. Care of people with dementia raises wider questions about care of the elderly in general and the value that we place on carers. I believe that carers have been overlooked by NICE in its decision and the impact on their lives was not really considered by the panel. Carers have the most contact with sufferers of the disease and experience first-hand the benefits of the drugs on their patients. Surely their input and well-being deserved to be given greater weight before the decision was made; it appears as if that was ignored.

If better care of dementia is to become a reality, better training is needed for staff, not only in the national health service but in the care sector. That would better serve the needs of sufferers not only of this disease, but of many others. By increasing the understanding of staff of the predicament that their patients are in and the potential problems facing them, perhaps we would address some of the concerns that I shall talk to the Minister about later today, which relate to malnourishment, dehydration and nutrition. Again, those are serious concerns. It is vital to ensure that people get the nutrition that they need. Often, older people find themselves in a vicious circle. Inadequately fed, they become confused. As they become confused, the dementia that they may already have is exacerbated, and because of that, their behaviour may be more challenging, which in turns leads to their being prescribed anti-psychotic drugs. Those anti-psychotics cause them to lose memory and behave more bizarrely as well—and it goes on and on. There is a downward slide to dependency and, ultimately, death.

A final point must be made about a potential cure for the disease. We appear to be far away from finding one. That relates to my first point: there simply is not enough funding for research into the disease. We must recognise the impact that dementia will have on our population as its prevalence continues to grow, and use that impact as the impetus to look seriously into curing the disease.

I started by referring to the person whose name is used to cover 55 per cent. of all dementias in this country, and to his work, which was very important. I hope that we can reach a point at which treatments are available and research is extended. I hope that the Minister can give us some sense of the direction now, because many people outside the House feel hopeless and powerless as a result of the decisions that NICE has made.

I congratulate the hon. Member for Sutton and Cheam (Mr. Burstow) on securing this Adjournment debate. I very much look forward to spending the afternoon with him when he comes to meet me in the Department about a separate issue immediately after the debate. He has a long track record of caring passionately about these issues, and I pay tribute to him. I also pay tribute to my hon. Friend the Member for North Swindon (Mr. Wills), who, appropriately in national carers week, is continuing his campaign to raise awareness of the needs of carers in relation to these challenging issues.

It is appropriate that we acknowledge that dementia is a heart-breaking condition. Of course it has a horrendous impact on the individual directly affected, but it also has an impact on the loved ones who see an older relative deteriorate, often quickly, in a way that is tremendously sad. Relatives do not have to deal only with the practical realities. It is a challenging condition in terms of its emotional impact on those who are closest to the people affected.

It is important to deal initially with the comments made by the hon. Member for Sutton and Cheam about the NICE process. First, the NICE recommendations are neither the final story nor the final guidance on drugs for Alzheimer’s disease. Stakeholders have until 15 June to lodge an appeal against the recommendations and at that point NICE will convene a committee to hear any appeals. It will publish a report of the appeal on its website.

It is also important to say that the process has been thorough—unprecedented almost.

I am writing to my hon. Friend the Minister about this, but I would be grateful if he did whatever he could to ensure that my constituent, Mr. Joe Culkin, is able to give evidence in that appeal.

It is not necessarily for me to determine who can give evidence, but we can certainly pass that information on to NICE and ensure that it is sensitive to my hon. Friend’s request.

As I was saying, the process has been thorough, with two public consultations on appraisal documents and a targeted call for further data from the drug manufacturers. Hon. Members would accept, I am sure, that the recommendations have changed significantly in the light of new evidence as the appraisal has progressed.

The hon. Member for Sutton and Cheam gave a slightly distorted picture. Many people profoundly disagree with NICE’s recommendations and we understand the disagreement and disappointment with the stage reached by NICE, but I am not entirely comfortable with second-guessing experts and specialists in the field who have a clear remit set by Parliament, and with implying that the hon. Gentleman is in a better position to make judgments than those experts and specialists.

The hon. Gentleman asked whether the Department of Health would support the appeal. As a Member of this House, he knows full well that it would be entirely inappropriate for the Department to join any appeal to NICE. It is entirely right that having set up NICE the Department should trust it to make reasonable and sound judgments on some of the most sensitive issues that face health policy in this country.

I understand that to a certain degree the Government have subcontracted out certain decisions about the cost-effectiveness and affordability of drugs. However, my point was that the Department submitted through the consultation a series of matters that it wanted the appraisal committee to consider. Is the Minister entirely satisfied that the appraisal committee gave due consideration to all the issues that the Department asked it to consider?

It is absolutely clear what stage we have reached in the process. It is appropriate that we let the process take its natural course and it is incredibly important that we do not undermine the integrity and credibility of NICE. The decisions and recommendations are not final and an appeal can still be lodged, as I have said. It is right that we allow that process to take effect, and the Department of Health’s role is not to second-guess in any way the process that has been conducted or NICE’s next decision-making stages.

I want to pick up on the point made by the hon. Member for Sutton and Cheam. I absolutely understand what the Minister is saying about the professionalism of NICE and the remit that it has been given. Is he satisfied that that remit adequately takes into account carers’ needs, which are important in the case of such dementias?

As far as I am concerned, NICE would say that, in reaching conclusions and any ultimate decision, it has a responsibility to take account of the impact on the carers of those with any health condition. That is a part of the process. My hon. Friend knows that NICE has to take into account many criteria and factors in reaching its conclusions. Of course, from an emotional point of view I, like other hon. Members, would like to say that, if it will make carers feel that the situation facing the people for whom they care will be greatly improved, let us give those carers what they seek from the process, but we all know that that is slightly disingenuous because we have a duty to take account of a range of other factors. NICE’s remit, the balancing act that it has to engage in and the different factors that have to be taken into account are laid down transparently and clearly.

We should never diminish the tremendous passion and emotion about the subject or say that they do not matter, but they are one of the reasons that NICE has conducted such an unprecedented process in public policy terms. The public anxiety, emotion and passion and the responsibility to respond sensitively to the needs of carers are the reason why NICE has gone through a process that has never happened in other circumstances and with other conditions. We should not attempt to devalue the genuine work that NICE has tried to do or to imply that NICE has not changed its position. Its position is not the same as in the past. There has been a genuine attempt to engage all stakeholders in reaching the recommendation.

Does the recommendation meet the views of all the experts, users and carers? Clearly it does not. I suspect that unless people are given what they want they will not welcome or accept recommendations or conclusions on the subject. We know how difficult it is for those who are directly affected. I do not say that in a patronising way, but NICE must consider the subject in terms of the criteria that Parliament has laid down for its duties and responsibilities. It is a difficult balancing act and the decisions have not been concluded. There is still the opportunity to appeal and to influence the process and I urge people to take advantage of that. NICE is obliged to take account of those representations.

Will the Minister confirm that he is satisfied that NICE has fully discharged its statutory duties and that the consultation advice given by the Department has been fully dealt with?

We have not reached the end of the process. There is still the opportunity for appeal, and I have repeatedly made that point. I expect that there will be an appeal and NICE will have to take account of that. I suspect that one of the arguments that will be advanced in the course of the appeal is that NICE has not taken account of all the factors that it should have. That was the central thrust of the hon. Gentleman’s argument. People who have participated in the project from NICE’s perspective will not necessarily accept that but that is one issue that NICE—not the Department of Health—will have to take into account.

It is important to make one point. The issue is not only prescription drugs and the way in which we treat and manage this dreadful disease, but the relationship between health and social care, the day-to-day practical and emotional support for carers and users, and the changes that we want to make to social care to achieve a more integrated approach. In the past, we had health on one side and social services on another, and we want to bring them together. If we get those issues right, it will significantly improve the quality of life for users and carers.

Question put and agreed to.

Adjourned accordingly at Two o’clock.