Multiple Sclerosis

– in the House of Commons at 9:45 pm on 13th March 2000.

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Motion made, and Question proposed, That this House do now adjourn.—[Mr. Pope.]

Photo of Paul Burstow Paul Burstow Shadow Spokesperson (Health) 10:48 pm, 13th March 2000

It is a little over a year since I last secured an Adjournment debate on the subject of multiple sclerosis. The Minister of State who is responding this evening responded to that debate as well.

At the outset of this short debate, I must declare an interest. I now have the privilege of serving as the honorary president of the Sutton branch of the Multiple Sclerosis Society.

What has happened in the past year? In my Adjournment debate last year, we learned that the Government were minded to refer beta interferon to the National Institute for Clinical Excellence, and that referral has taken place. The result is that those with the secondary progressive form of MS are left in limbo, waiting to see whether the drug will clear the affordability hurdle. Those with relapsing-remitting MS are waiting to see whether the goalposts will be moved for them too.

In the meantime, postcode prescribing continues. Where people live still matters more than the criteria used to assess whether they are eligible for beta interferon treatment. Just two in every 100 of the United Kingdom multiple sclerosis population receive beta interferon. The European average, by contrast, is 12 in 100. Even given the criteria published by the previous Government in executive letter 95/97, which set out eligibility for access to beta interferon for those with relapsing-remitting MS, people who qualify do not receive the drug.

I want to draw attention not only to the drug, but to the services surrounding MS. A survey undertaken last year found that six out of 10 health authorities could not estimate or had not estimated how many people might benefit from beta interferon. Those that had made an estimate found that fewer than half of those who could benefit were being prescribed beta interferon. It is nothing short of a scandal that prescribing is so low, and left so much to chance.

Beta interferon is not the only matter on which MS sufferers face a postcode lottery. Support services that help them to manage their symptoms are similarly affected. In November 1998, a group of senior neurologists signed a statement that made clear their concern about the availability of MS health services. The signatories included leading specialists in MS who work in neurology centres across the country. They declared: We believe that the National Health Service has failed to respond adequately to the needs of people with MS and that services for them, with some shining exceptions, are seriously deficient in most parts of the country. A year later, Ministers announced that they would introduce national guidelines on the management of MS in England and Wales. Last Wednesday, the Multiple Sclerosis Society organised a mass lobby of Parliament to press for action on services and for an end to postcode prescribing. More than 1,000 people made the trip to Westminster to lobby their Members of Parliament. I am sure that the lobby will have done much to raise awareness among Members, but I hope that Ministers have taken note of it too. Those people said—certainly those from my constituency to whom I spoke said—that the issue will not go away.

The catalyst for my debate last year was a constituency case. In February 1999, Josephine Timms wrote to me, saying: I am 39 years old. I have a husband and two sons, one aged 12, and the other 9. At the end of July 1998 I was diagnosed as having Multiple Sclerosis. The initial expectation was that I would have an attack, and then it might be several years until I suffered a further one. This was regrettably not the case. I had two further very bad "episodes" which have left me disabled. I became quite involved in the case, and it took many letters over a long time, from Josephine and from me, before the local health authority finally realised even that she was resident in the area and therefore its responsibility. At that point, she was finally referred for assessment by neurologists.

I am delighted to tell the House that Josephine started a course of beta interferon on 24 February. However, in a recent letter, she summed up matters as follows: All I need is a little bit of time to see my two young sons grow into men when they don't need their mummy quite so much. Hopefully this treatment will buy me that time. Buying time is what beta interferon can do. It is not a cure, but for Mrs. Timms and thousands like her it is the light at the end of a very long tunnel.

Josephine's case highlighted not just the availability of the drug, but the lack of planning and support services for people with MS. MS leads to a range of complex symptoms that usually worsen over time. Symptoms include problems with mobility, spesech impairment, memory loss, incontinence, pain, spasticity and extreme fatigue. As a result, a variety of health care services are necessary for effective management of MS, including occupational therapy, speech therapy and continence care. Because of the illness's progressive nature, there is a need for patients to be properly monitored so that they can receive appropriate medical and social care for their needs at a given time.

A significant number of patients do not receive specialist advice after they have been diagnosed. After diagnosis, many types of information are relevant to people with MS, such as information about disability discrimination rights, social security entitlement and symptom management. However, for many people with MS, that information is not signposted. A survey of 16,000 people with MS throughout the UK, conducted in 1999, found that more than eight out of 10 respondents were not given written information about MS to take away and read when they were diagnosed.

General practitioners will encounter few MS patients during their professional careers, and they cannot therefore reasonably be expected to gain a high level of understanding of managing MS. The lack of specialist MS care can result in some people with MS developing unnecessary complications.

One form of specialist care is the development of MS nursing. At the Manchester royal infirmary, patients can take advantage of such specialist nursing services. People with MS and their carers are able to receive information and counselling from the time of diagnosis onwards. That nursing service also monitors the condition of vulnerable patients in the community and can intervene to prevent patients from developing serious complications, such as urinary tract infections.

An evaluation of the impact of MS nursing in Manchester showed that in-patient admissions for some patients fell because of the service. However, Multiple Sclerosis Society research showed that eight out of 10 MS patients do not have access to such specialist nursing.

Closer to home, I have been told by the chief executive of the Merton, Sutton and Wandsworth health authority that there are no specific budget or policies for the care of people with MS. There is no disease register for people diagnosed with MS in my health authority district. How can sensible planning be undertaken when we have no idea of the prevalence of a disease? However, to be fair, many members of the Sutton branch of the Multiple Sclerosis Society have been enthusiastic in their praise of Atkinson Morley's hospital and its assessment clinics and staff.

Looking beyond my patch, evidence from local health decision makers reinforces my concern about the quality of MS services. In last year's debate, I referred to the 1998 survey carried out by the Association of Quality in Healthcare; its findings were disturbing. In 1999, the survey was repeated. It found major gaps in MS provision across the country.

The total population in the areas of authorities responding to the survey was 27 million. Six out of 10 of the health authorities that responded had no separate contract for MS services. Only two authorities in 100 had issued a consultation document on MS services. A third had held no consultations before setting out its MS policy. That is despite the fact that health authorities have a duty to consult their local population before commissioning services. Only 23 per cent. of authorities specified the range of services that must be provided by clinicians.

In March last year, I asked the Government for their response to the AQH survey. Finally, in October, the Minister of State, Department of Health, the hon. Member for Southampton, Itchen (Mr. Denham) wrote to me. The letter stated: Turning to the Association for Quality in Healthcare (AQH)'s report on Health Authorities' approaches to MS, the Department has not followed this up specifically. Why not? Lack of planning and lack of consultation leave health authorities ill equipped to commission services for MS sufferers.

In 1997, the Multiple Sclerosis Society conducted a major symptom management survey of people with MS. The sample of 223 people with MS included people of different ages and degrees of disability. It also looked at people who had suffered from the illness for different periods of time. In particular, the survey found that only 8 per cent. of people were seeing rehabilitation specialists.

A more recent survey of 150 MS patients conducted by the National hospital for neurology and neurosurgery found that only one third of people with severe disabilities were seeing a physiotherapist. When will the new guidelines, promised last November, be published? What status will they have? What resources will they command?

Beta interferon has been shown to reduce the number of MS relapses by an average of one third in a year. Fewer relapses mean fewer hospital admissions and a better quality of life. The drug can reduce not only the number of relapses, but their severity.

I have several points to make. First, services that treat symptoms are no substitute for drug therapy that treats the disease. Nursing cannot slow the progression of the disease—beta interferon can do so.

Secondly, Ministers have said that the National Institute for Clinical Excellence will need to assess whether the drug can be better targeted. Can the Minister assure the House that targeting will not lead to a catch-22 situation? The current guidance on beta interferon already targets the drug. Only MS sufferers who have had two relapses during the past two years are considered. The search for better ways to target the drug should not be used as a way of denying it completely.

Thirdly, NICE has the option of recommending a clinical trial to address outstanding research questions, such as effective targeting and the results of combining the drug with other therapies. Clinical trials can make a valuable contribution to our understanding of MS and how best to treat it. However, does the Minister agree that it would be ethically unacceptable for MS patients to have access to beta interferon only by joining a clinical trial?

The rules governing clinical trials usually insist that patients have a real choice to enter a trial. That is particularly the case where the treatment is experimental and could damage the patient's health. However, in the case of beta interferon the drug is licensed for both forms of MS. Many neurologists wish to use the drug because, in their clinical judgment, it will benefit their patients. However, if the only way for someone like my constituent Josephine to get the drug is through a clinical trial, she really has Hobson's choice. For her, the drug buys time for herself and for her young family.

Although I am delighted for Josephine that she is now receiving the drug, many thousands of other people just like Josephine are waiting for the drug; and this Hobson's choice gives just a 50:50 chance of obtaining the drug, because such trials, obviously, are placebo controlled.

Many neurologists regard the recruiting of people for such a trial as unethical. The MS research group of the Association of British Neurologists found that the majority of neurologists would not recruit patients with relapsing-remitting MS on to a one-to-one placebo trial. A United Kingdom trial would be ethical only if the drug was available to be prescribed outside the trial.

I should like to know what the Government's position is. In August 1999, 54 neurologists wrote to the then Secretary of State for Health, the right hon. Member for Holborn and St. Pancras (Mr. Dobson), to protest about the rationing of beta interferon. In his reply on 15 October 1999, the Minister of State, the hon. Member for lichen said: appraisal by NICE may in turn help to identify some of the issues which could subsequently form the basis for ethically valid research. Can the Minister confirm that the reference to ethics in that letter means that the Government accept that a placebo-controlled trial of beta interferon in the UK would be unethical?

In conclusion, MS patients are dealt with in a very disorganised and unsystematic way. In many cases, follow-up of diagnosed patients is poor. As a result, many patients with relapsing-remitting MS are left to deal with their attacks in the absence of medical help, with only an untrained and hard-pushed relative as a carer.

There is an astonishing lack of understanding about MS, its various forms and the implications for patients of having the disease, at all levels in the NHS and beyond it, in social care. What is needed is a well-planned and properly delivered service for MS patients. It is in that context that the best returns are likely to be achieved from beta interferon.

I should like the Minister to answer two questions tonight. First, when will the new guidelines be ready? Secondly, do the Government accept that a placebo-controlled trial of beta interferon in the UK would be unethical?

I want to finish with a further quote from my constituent Josephine Timms. I appreciate that Beta interferon is not a cure but I see it as the light at the end of a very long tunnel, which has taken up so much of my time and valuable energy. What happens to the people like Josephine who do not have the energy and persistence to chase and cajole both their MP and their health authority to get the drug and other support? It is those people who do not have that energy who need some answers from the Government.

Photo of John Hutton John Hutton Minister of State, Department of Health, Minister of State (Department of Health) (Health) 11:03 pm, 13th March 2000

I start by once again—we have been here before—congratulating the hon. Member for Sutton and Cheam (Mr. Burstow) on bringing forward this subject for our debate tonight. The hon. Gentleman has shown on many occasions that he takes a close interest in these issues, as many hon. Members do, and his knowledge and understanding of some of these issues clearly showed in his comments.

The hon. Gentleman was right to say that multiple sclerosis is one of the most common diseases of the central nervous system. It is estimated to affect between 80,000 and 90,000 people in the United Kingdom. Multiple sclerosis can be very difficult to diagnose and treat, and at present there is no conclusive diagnostic test. The symptoms experienced by patients can be symptomatic of many other conditions.

Multiple sclerosis often strikes people when they are young adults—the peak age of onset is between 20 and 40—and is thought to arise from damage to the myelin sheath around nerve fibres that help conduct nerve impulses efficiently through the central nervous system. When such damage happens, disabilities can vary from impairment to speech, vision and movement to incontinence, as the hon. Gentleman said, or even severe paralysis.

The disease course in multiple sclerosis is unpredictable. People most often present initially with relapsing-remitting MS, in which relapses or acute attacks of neurological disability are followed by periods of remission. Later, as chronic problems accumulate, the disease may become more progressive, with more acute relapses. Management of MS therefore involves treatment of relapses caused by increased disease activity, and a care programme to minimise and control specific problems such as spasticity, bowel and bladder problems.

The different phases of the disease mean that people with MS have a wide range of health and other needs and that these needs, particularly for health care, will not remain static but will nearly always change over time. Patients with long-term conditions such as MS therefore require different levels of support and health care at different times. Most health authorities now have procedures in place to ensure that people with MS receive the treatment and care that they need.

Everybody, wherever they live, expects fair access to the most effective treatments, and the Government are taking steps to improve consistency. The new policies are designed to improve the quality of care and treatment that the NHS offers its users, to improve access and equality, and to ensure that service users have a greater say in what services are provided and how they are delivered.

There are now real opportunities to develop innovative care approaches for people with long-term care needs. We have introduced long-term service agreements built on pathways of care. The agreements will link primary care, secondary care and social care where appropriate. We expect that to be a better approach for people with long-term conditions such as MS. Discussions about care pathways will involve users and carers as well as health service professionals. Care pathways are expected to include an appropriate range of preventive, diagnostic, palliative, rehabilitative and supporting care components that are intended to produce an integrated programme of care for the individual service user. The care pathway approach will be particularly helpful for long-term medical conditions where, following accurate and timely diagnosis, a patient's care will generally be managed outside an acute setting. That is likely to be the case for many neurological conditions, including MS.

The development of such pathways reinforces the need for seamless working between health, social services and other agencies such as those involved in housing. People with illnesses such as MS know only too well how failures to deliver the right package of care can produce frustration and unnecessary difficulties in the daily activities of living. The hon. Gentleman referred to the problems that his constituent has experienced, and we take those issues very seriously.

Solving such long-standing problems means that care agencies must work more closely together to ensure that treatment and support systems operate in ways that help people to lead active lives. That includes making sure that they are able to work as long as possible—retaining people with health problems in their jobs is another priority for the Government. Health and social services are expected to play their part in helping people to stay at work as part of our welfare to work programme. The flexibilities created by the Health Act 1999 will enable health and social services partners to provide more joined-up care to MS sufferers and other groups of patients. I very much hope that health and local authorities, including those in the hon. Gentleman's constituency, take advantage of the new opportunities.

I know that some NHS services in the recent past have been the cause of concern to voluntary organisations dealing with neurological disease. Indeed, last year, the Multiple Sclerosis Society published "A Survey of Multiple Sclerosis Provision in England 1998–99". The survey was designed to establish how commissioners approach provision of MS services and to build a picture of service provision in England. It is true to say, as the hon. Gentleman did, that a somewhat mixed picture of MS service provision emerged.

The Multiple Sclerosis Society organised a very successful lobby of Parliament last Wednesday where it highlighted some of the results of a forthcoming survey on community provision, which is expected in the summer. I understand that the survey shows that as many as one in four people with MS do not receive any community care services at all and that a majority did not receive either written information or specialist support at the time of diagnosis. That is clearly unacceptable, and I hope that that is not the case with people who have been diagnosed recently. The society has, together with people with MS and the National hospital, also developed comprehensive guidance on standards for the provision of health care for people with MS.

Other changes, such as the introduction of a small number of regionally commissioned specialist services and the move towards primary care group commissioning, have raised further anxieties among neurological voluntary organisations that neurological services will not receive proper attention during the new commissioning process and that the services might be commissioned by people with insufficient knowledge of neurology to ensure that services meet neurological patients' needs.

To address those anxieties, a compendium of good practice on the commissioning of neurological services is being developed. The compendium is pulling together all the good practice that has been produced by many of the voluntary organisations in the neurological field and will act as a single, succinct source of information for health care commissioners.

Photo of Paul Burstow Paul Burstow Shadow Spokesperson (Health)

On this issue, as with all the developments that the Minister has outlined so far, groups outside the House will most want to hear about time scales. When will the compendium be ready?

Photo of John Hutton John Hutton Minister of State, Department of Health, Minister of State (Department of Health) (Health)

I am afraid that I cannot be specific about when the compendium will be available. Obviously, I hope that it will be ready as soon as possible. I hope that the hon. Gentleman understands that a lot of work has to go into that, and obviously the only point in drawing up a compendium is to get it out to the health service as soon as possible. We do not initiate such projects simply to amuse ourselves; we do it for a purpose, which is to improve the commissioning of health services. We have actively engaged neurological voluntary organisations such as the MS Society in that work and they have made a substantial contribution to its development.

As I have already said, the commissioning compendium has direct patient involvement in its development. Such involvement has always reflected best practice, and now the Government are seeking to make it standard practice, not just in the development of national policy but in the commissioning of local services. I am pleased that the MS Society is working with the NHS to develop specialist MS nursing schemes. The hon. Gentleman did not refer to research—I perfectly understand why—which is important in supporting the policy developments for which he and others are calling. He will be aware that the Medical Research Council spent approximately £640,000 on multiple sclerosis in 1998–99. The MRC also gives considerable additional amounts to fund basic underpinning research on issues such as nerve function and damage, which are not included in the figure of £640,000.

Another area of considerable interest to many people with MS is the therapeutic use of cannabis. The Department of Health supports the evaluation of the therapeutic use of cannabis by clinical trial, and is working closely with the Royal Pharmaceutical Society to put research on to a better scientific footing. In the short term, that has led to an MRC grant of almost £1 million being awarded to the neurology department of Plymouth hospital NHS trust to undertake a multiple randomised controlled trial of cannabinoids on spasticity in multiple sclerosis. The trial will recruit 660 patients with MS from throughout the country who have significant spasticity in some of their leg muscles. The hon. Gentleman might be interested to know that it will be the largest single study of symptom treatment in MS ever undertaken in this country.

I am sure that the hon. Gentleman will be interested to hear also that we are supporting a particularly important study being undertaken by Dr. Jeremy Hobart of the Institute of Neurology. Its aim is to develop a patient-based measure of outcome in patients with MS for use in clinical trials and clinical audit. To guarantee that the measure is appropriate and clinically useful, MS patients are central to the development process. The project is costing some £160,000. It started on 1 November 1997 and is due to end this April. The overall aim of the health technology assessment programme is to ensure that high-quality research information, cost-effectiveness and the broader impact of health technologies are properly assessed.

Photo of Paul Burstow Paul Burstow Shadow Spokesperson (Health)

The Minister is further illuminating the subject, and I am grateful for that. Would the Government regard it as unethical to have a clinical trial that effectively ring-fenced the prescribing of beta interferon so that it was not available outside the trial?

Photo of John Hutton John Hutton Minister of State, Department of Health, Minister of State (Department of Health) (Health)

If the hon. Gentleman will be patient, I will come on to what NICE is doing about that. If I do not get to that point by the end of play, I will certainly write to the hon. Gentleman and give him the details that he seeks.

In the light of the progressively expanding evidence base, the health technology assessment programme has gone on to commission secondary research in the broader field of MS treatment. In consultation with clinical neurologists and representatives of the Multile Sclerosis Society, reviews are being commissioned on the five topic areas identified as being of greatest clinical, patient and policy concern.

There are other funding streams that we make available to support work in that general area, including funding that we make available directly to the Multiple Sclerosis Society, under the section 64 scheme. We are funding several projects, one of which involves developing and maintaining databases on MS treatment and trials so that clear and authoritative information can be given to people with MS.

The hon. Gentleman spent most of his time talking about problems surrounding the availability of beta interferon. I want to address the concerns that he and many other hon. Members have expressed in recent debates in the House.

The Government have a substantial agenda of work in place that is designed to improve the quality of treatment offered by the NHS. As the hon. Gentleman will be aware, that includes setting up NICE, the introduction of clinical governance and improving the way in which the NHS commissions and uses research. However, we of course recognise that the licensing and prescribing of beta interferon is an issue of concern.

I understand that evidence is that beta interferon drugs reduce the rate of relapses in relapsing-remitting MS by some 30 per cent.—the hon. Gentleman referred to that—on average in a range from 14 to 44 per cent. Betaferon was licensed for treating secondary progressive MS on the basis of evidence that, if used for three years, it might delay disease progression by up to one year.

Clinicians treating patients and those advising health authorities on their overall policy need to take account of both the clinical effectiveness and cost-effectiveness of beta interferon. It appears that there is evidence that some patients with relapsing-remitting and secondary progressive forms of multiple sclerosis can benefit from the use of beta interferon, but that, sadly, those short-term improvements are temporary. The cost of beta interferon treatment is estimated at approximately £10,000 a year per patient.

Let me make it clear that the Government are committed to improving standards of health care and to ensuring that, when newer treatments, including new medicines such as beta interferon, represent a genuine therapeutic advance and are cost-effective, they are introduced into the national health service as fast as possible. In fact, beta interferon has taken on an even higher profile since its licence was extended to the treatment of secondary progressive MS at the beginning of last year.

Not surprisingly, the licensing of beta interferon has for the first time given people with MS some hope that there might be a pharmaceutical remedy for their condition. However, it is terribly important that no one raises any false expectations about the ability of beta interferon or any other drug to combat MS. To be fair to the hon. Gentleman, he made that point clearly, too. Beta interferon is not a cure for multiple sclerosis; there is no cure for MS.

Evidence from trials on the clinical effectiveness and cost-effectiveness of beta interferon appears to many commentators to be far from clearcut. That is why different health authorities and their clinicians are arriving at different conclusions, which can result in differences in the pattern of provision of beta interferon. That is exactly why we have asked NICE to carry out an authoritative appraisal of the evidence. The work of NICE is the common-sense way in which to end the variations that the Conservatives' internal market did so much to create.

The great advantage of NICE is that it brings together the expertise not just of clinicians, but of managers and of patient groups, in order to make an authoritative assessment of evidence emerging from trials. NICE guidance will support front-line clinicians and help to reduce the confusion, which I am perfectly prepared to accept currently exists. I obviously cannot pre-empt what NICE will conclude, but I think that it is undisputed that the NHS should seek to use its resources to achieve the greatest possible health gain for patients. With this in mind—

The motion having been made after Ten o'clock, and the debate having continued for half an hour, MR. DEPUTY SPEAKER adjourned the House without Question put, pursuant to the Standing Order.

Adjourned at eighteen minutes past Eleven o'clock.