Westminster Hall
Tuesday 31 March 2009
[Mr. Eric Illsley in the Chair]
Motor Neurone Disease
Motion made, and Question proposed, that the sitting be now adjourned.—(Chris Mole.)
9.30 am
Mr. Eric Illsley (in the Chair): The temperature in the Chamber was quite high when we came in, so I will relax the Speaker’s ruling on jackets, and hon. Members may remove them if they so wish during this debate.
Mr. Mark Todd (South Derbyshire) (Lab): I had wondered about the temperature and whether it was due to my heavy cold, which has made my already deep voice even deeper.
I am grateful to the Motor Neurone Disease Association, which suggested the topic for the debate. It is the only national organisation that tries to support people who suffer from this terrible disease. One of its focuses is, of course, to find a cure, and another important one is to support people through the process of the disease until their death.
Not many people know a huge amount about motor neurone disease, which is quite rare. About 5,000 people in the UK suffer from it and partly because of its late diagnosis the typical period between diagnosis and death—it is incurable—is about 14 months. I shall return to why that is material. The disease affects the motor neurones—the nerve cells in the brain and spinal cord that control muscles. All muscles are affected, including the respiratory muscles, which control regular breathing—critically when asleep—and keep people alive. Ventilatory impairment is one of the most frequent causes of eventual death in people who suffer from motor neurone disease. The respiratory muscles fail to work and the sufferer is unable to breathe. The process is very distressing, and causes the sufferer and their carers tremendous anxiety. I shall speak about some of the issues that arise for carers of people with MND.
Not only is ventilatory failure a main cause of death; it is a main cause of poor health in the later stages of the illness because poor sleep leads to dramatic loss of quality of life, including headaches, cognitive failure and, in extreme cases, hallucinations when awake. It can also lead to lethargy, requiring additional care simply to maintain the normal course of life. Ventilatory problems are a critical part of the path of motor neurone disease in the typical survival period after diagnosis. The disease dominates family life, and sleep impairment is a critical part of the impact on carers. If a sufferer is not sleeping properly and is perhaps in danger of dying in their sleep, a carer becomes anxious and spends a lot of time supporting the sufferer and trying to help them through the episodes. That leads to poor health among carers, so the difficulty has a multiple effect.
Non-invasive ventilation, which is the subject of this debate, is a relatively simple technology involving a pump, an air filter and a means of delivering air, usually
a mask, into the sufferer’s lungs, essentially to keep air flowing into the body to keep the sufferer alive when the ventilatory muscles are not functioning properly. The full kit is not particularly expensive, and costs about £6,000. The face mask and so on are obviously personal to the individual, but the key piece of technology supporting the ventilatory muscles—the pump—is reusable and can be passed to another patient when necessary. Unlike a drug, it is an efficient means of helping people with a terrible illness.
Non-invasive ventilation relieves sleep disturbance because it provides the passage of air into the body at regular intervals without the use of the muscles, so the sufferer can sleep normally. It can also be used for longer periods; in the later stages of the disease the problem occurs during the day, as well as at night. Clinical research published in 2006 showed that non-invasive ventilation typically increased the median survival period for people with motor neurone disease by seven months. As I said, the typical survival period is 14 months, so seven months would be a material change in someone’s survival, and a major change in their quality of life and that of their carers.
I have met people who have had the technology available to them, and it has revolutionised their own feelings and transformed the life of the family caring for them, who can be more relaxed about the sufferer going off to sleep and can lead a more normal life when at home looking after the sufferer. It has a holistic impact on the family unit affected by motor neurone disease. Studies to date have shown that it is a profoundly beneficial technology.
One might think that suggests that a simple decision could be made about the availability of the technology to MND sufferers. It is relatively cheap, is largely reusable, substantially lengthens life, and improves life quality for sufferers and their carers. The judgment seems to be relatively simple, so it is difficult to explain why the only study that has been done on availability showed that only about 3 per cent. of those suffering from motor neurone disease have the technology made available to them. It may not be appropriate for some sufferers of MND, either because the disease has not yet affected the respiratory muscles, or for other clinical reasons, but it is hard to understand how only 3 per cent. of sufferers might benefit from the technology.
The evidence also shows that use of the technology is very unevenly distributed among neurological consultants who choose to prescribe it. Some neurological consultants regularly prescribe the technology for those suffering from motor neurone disease; others scarcely prescribe it at all. Prima facie, one would expect in that circumstance that the National Institute for Health and Clinical Excellence would be the first port of call, because it is a classic case of the postcode lottery and uneven distribution of care that NICE was set up to address. It is not surprising, therefore, that shortly after the clinical study showed the benefits of the technology, NICE was approached to suggest that a study be done. That was in 2006—more than three years ago.
I say straight away that I am an enthusiastic defender of the NICE process. There has been a profound improvement in the way in which we allocate resources in the NHS and there is a much better framework for establishing best practice in both technologies and medicines
for NHS patients. Of course there is controversy attached to the treatments; that is inevitable. I am not speaking as a regular critic of the institution—far from it. I am a regular defender of it, sometimes to my constituents, who are not as willing to listen to that side of the argument as I am.
However, it is surprising that there was such a lengthy delay. It is also surprising—I hope that my right hon. Friend the Minister provides some useful information on this—that following contact with the Department to suggest that NICE engage in the study, there was an interval of nearly three years before a referral was made to NICE at the end of last year to consider the technology. That is harder still to understand when NICE’s own studies, through its consideration panel, showed that the technology had a score of four and a half out of five. Clearly, as I have said, the technology met many of the criteria that NICE is interested in when considering a particular treatment and technology. We require explanations of what happened and why there has been such a delay.
We are now at the point we are at. NICE has had the referral and is considering how quickly to proceed. Regrettably, what it has said so far is that it will proceed with a study starting at the end of this year and finishing in 2011. Let me put that in a time frame relevant to those who suffer from the disease. Assuming that clinical practice does not alter voluntarily—sadly, it often does not—it will mean that in the next two and a half years, before NICE pronounces, some thousands of people suffering from the disease will not receive that treatment.
The case is solid for rapid consideration of the technology and for a judgment to start that consideration as soon as possible. I hope that the Minister gives us some reassurance that that is the message she will be giving to her Department and those who liaise with NICE on its work programme, and perhaps to NICE itself. I recognise that it is an independent agency—it should be independent. Nevertheless, it should listen hard to its stakeholders and those who are critically interested in the care of people who suffer from terrible diseases such as motor neurone disease.
9.44 am
Dr. Julian Lewis (New Forest, East) (Con): I pay tribute to the hon. Member for South Derbyshire (Mr. Todd). He is the chairman of the all-party group on motor neurone disease, and only on 11 March I attended a meeting of the group for the first time. At that meeting, the question of NIV treatment having been discussed, it was decided that a good way forward was to apply for a debate in Westminster Hall. I was amazed that the hon. Gentleman managed to secure the debate at the first attempt. If ever I decide to become a betting man, I will regard him as at the top of my tipsters list.
Dr. Lewis: I understand that people already consult the hon. Gentleman.
Dr. Lewis: Well, I shall join the throng in future.
I must explain that although I am operating somewhat out of my comfort zone, I was so impressed by the case that was made for the need to get the equipment into the possession of people suffering from this dreadful wasting disease that I decided to take a chance and venture into areas on which I am wholly dependent on advice and briefing from the Motor Neurone Disease Association. I shall unashamedly be relying on the material it has given me.
I often say to constituents who come to see me with dreadful problems that MPs have influence but no power. We cannot overrule bodies that are empowered by law to take responsibility for policy implementation. However, we can sometimes speed up a process whereby those bodies would probably get round in the end to doing what needs to be done, because it is in line with policy as laid down by Parliament and Government, but they have been dragging their feet.
Like the hon. Gentleman, I do not intend to cast any aspersions on the work of NICE. I do not know enough about its queuing system for dealing with one task after another. I fear that it may operate on a first come, first served principle, which may mean that a relatively simple decision about a relatively inexpensive measure that needs to be taken has to wait a disproportionate time before it is considered, purely because it is in a queue behind a much more complicated decision that has to be taken about much more expensive equipment or treatment for a much more challenging dilemma and disease.
Therefore, I hope that what we say today in this Chamber will not overrule any procedures that NICE must follow, but will give it a bit of a prod, especially when we bear in mind everything that the hon. Gentleman said about the life expectancy that someone diagnosed with motor neurone disease can have. Let us not forget that one vicious aspect of the disease is that the person’s mind remains totally unaffected right up to the end. They know exactly what is happening; they are well aware of the fact that their whole system is gradually closing down. It is of great concern if, knowing that they are under a death sentence of 14 months—that is the average time from diagnosis to death—we are not doing everything we can to make that time as bearable for those people as possible.
I am told by the Motor Neurone Disease Association that one reason why I may not have heard too much about problems relating to NIV treatment in my constituency of New Forest, East is that we are very fortunate in my part of the world. When someone is diagnosed with motor neurone disease, the first step is for their neurologist to refer them to the respiratory services department. That department is usually found in a general hospital, and there is certainly one in Southampton general hospital, which serves my constituents.
The disease can lead to rapid degeneration, including in the gaps between appointments with the neurologist, so if the neurologist does not refer a motor neurone disease sufferer to respiratory services after their first appointment, that person’s situation and quality of life may deteriorate substantially before it is possible to see the neurologist again and get a referral on a second or subsequent appointment. Making neurologists aware of
the need to anticipate what may happen and to make a referral as soon as possible is therefore one aspect of this question.
A top neurologist specialising in this terrible disease serves my constituency and the people of the Southampton area. Respiratory services at Southampton general hospital also have a fabulous person working for them, who is in a good position to supply the NIV kit as soon as she gets the referrals. The kit consists of a box, pump and tubes to allow air to be supplied to the patient overnight and, in the later stages, possibly in the days as well. I understand that Hampshire primary care trust, which serves my constituency, also supplies these kits. I am therefore speaking from a very fortunate minority position and I congratulate the general hospital, the neurological department, the respiratory services department and the PCT on what they are doing for MND sufferers in my part of the world.
NICE apparently rates the priority with which it wishes to deal with the question of supplying pumps at four and a half out of five on its priority scale—very highly, in other words.
On the question of expense, we have heard that the whole equipment package costs £6,000 per person, but all that money is not lost. After the initial period of use is, sadly, over, the pumps are entirely reusable, and a large part of the cost is recycled for the benefit of future sufferers.
NIV is believed to increase the lifespan of MND sufferers by up to 11 months. Compared with other forms of treatment, which are much more expensive and are believed to increase lifespan by up to three months at most, NIV is obviously incredibly good value for money. However, we should look at the issue not just in monetary terms, but in terms of humanitarian assistance. As has been said, when one knows that one is going to die in little more than a year, what is more valuable than being able to make those few remaining months tolerable and worthy of living, rather than constantly wishing that the agony was over? As the MND Association says,
“The human cost in terms of life extension and quality of life of denying access to this vital treatment for so many people with MND is enormous.”
Ventilatory failure arising from respiratory muscle weakness, which gradually progresses as the disease takes hold, is the most common cause of death in MND and is frequently preceded by sleep-disordered breathing. That, in turn, is associated with considerable morbidity, which causes disturbed sleep, severe daytime sleepiness and headaches, reduced appetite and cognitive impairment. Some people with MND have such disturbed sleep that they report having hallucinations during the day. Anybody who has ever suffered from severe sleep deprivation for any reason—mental breakdown, physical illness, abuse by captors in a conflict situation—will know the devastating effect of being systematically deprived of sleep. It is the worst form of torture that one can inflict on a human being, and that is what this disease does to sufferers during much of the 14 months that they have left once the diagnosis is confirmed.
Clinical trials have shown that NIV significantly improves quality of life for people with MND by increasing blood oxygen levels, which leads to significantly higher-quality sleep, fewer terrible daytime headaches and increased appetite. It is what the military would call a force multiplier. If people’s brains can receive more
oxygen, every one of their remaining bodily and mental functions will be improved for as long as they live, their quality of life will be better and the period left with their families and friends will be extended.
The MND Association gives an example of the personal experiences of someone who has had NIV:
“Mr S said that prior to using NIV he was waking very frequently at night—up to 39 times per hour according to his consultant. This meant he felt very unwell during the day, describing how he felt as having a very bad hangover. He was also hallucinating during the day. Since using NIV however he sleeps well at night, feels much better during the day and has stopped having hallucinations. He said that NIV has completely changed his life. His wife...said that NIV was a lifeline for them.”
Research carried out in 2001 and funded by the MND Association showed that only 5.5 per cent. of people with MND who were under review were receiving NIV. There was a marked variation in clinical practice, with just three neurologists responsible for 30 per cent. of all referrals in the whole United Kingdom. I have no idea how many neurologists in the UK have MND sufferers on their books, but the fact that only three, who are clearly enthusiasts for the treatment, account for almost a third of referrals nationally indicates that there is a huge ocean of unnecessary suffering out there.
As soon as research was published showing that NIV was effective in treating MND, although not widely available, the MND Association suggested NIV to NICE so that guidance could be produced for the NHS. As we have heard, that was in January 2006. Nearly three years later—at the end of 2008—the Department of Health finally referred NIV to NICE. There must be all sorts of sensible reasons for that delay, but I do not think they would have cut much ice with the thousands of people who were suffering from MND over that long period.
Throughout those three years, the MND Association repeatedly asked for progress on NIV and was told that it was, as I have said, considered a high priority, scoring four and a half out of five in NICE’s consideration panel for topic selection. All I can say is that it makes me wonder about those rated with lower priorities. Given all the billions that have been spent on health, if NICE is indeed doing a good job its capacity is clearly under-resourced. It needs to do a good job—if that is what it is doing—more quickly.
When NIV was finally referred to NICE, the MND Association expected work on the guidance to start straight away, but NICE said it could not start work until late 2009, as we have heard; the guidance was due to be published early in 2011. The MND Association says—who can disagree?—that it is unacceptable that it could take five years to produce guidance for a vital treatment for that fatal disease. More than 8,000 people will have died from MND during the time in question, many of whom will have been denied access to the life-extending and life-enhancing treatment offered by NIV.
NICE has said it will produce a short clinical guideline on NIV and that it can work on only a small number of projects at any one time to produce such guidelines. The MND Association has identified several such projects that will be completed this spring, and it therefore believes that work on NIV can start then. My appeal to the Minister is that she use what influence she feels she properly can to get the simple and relatively inexpensive
process in question into that available slot in the NICE agenda, if statute and the proprieties that govern her role allow her to exert such influence. The questions I have been asked to raise are: why it took nearly three years for NIV to be referred to NICE, when it was considered a high priority; whether the Minister thinks it acceptable for it to have taken that long, and for 8,000 people with MND to die waiting; and why NIV work cannot begin when other short clinical guidelines are completed in April. It would be interesting to receive an insight into how NICE prioritises treatments that are referred to it in that way.
I said earlier that I am operating out of my comfort zone, which is usually mainly military and security matters. However, there was a strange convergence of my interests, because when I was preparing for the debate my mind went back to one of the most inspiring interviews I ever read. It inspired me so much that I had special copies printed and framed, and was able to present one of them to the widow of the person who gave the interview. He was the late Lord Cheshire, better known as Leonard Cheshire, VC, DSO, DFC, and countless bars to those awards. He was famous twice over, but he deserves to be famous three times over. He was famous for being one of the most courageous and certainly the most highly decorated bomber pilot of world war two. He was famous also for his piety and his amazing achievement in founding the Cheshire Homes for the terminally ill.
I feel that he should be famous as well for the interview that he gave. The article, by Anne de Courcy, was published in the Evening Standard a few days after Lord Cheshire died in 1992, and explains:
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