HC Deb 10 February 1997 vol 290 cc115-22

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

9.59 pm
Mr. Gordon Prentice (Pendle)

Thank you, Madam Speaker, for allowing me a second opportunity to raise an issue that is of great importance to all who are interested in the treatment of multiple sclerosis—those who suffer from it, and those who do not.

I want to highlight two main issues. First, there is great inequality throughout the United Kingdom in access to treatment; secondly, there is a lack of understanding of the special needs of those with the disease among some NHS purchasers and providers. Many of the surrounding questions were mentioned by my hon. Friend the Member for Stratford-on-Avon (Mr. Howarth) in his debate on neurological disorders on 29 January.

For too long, multiple sclerosis has been regarded as a Cinderella condition. The disease was first identified in the 1860s—

It being Ten o'clock, the motion for the Adjournment of the House lapsed, without Question put.

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

Mr. Prentice

I did not fully understand that procedure, Madam Speaker.

Madam Speaker

Let me inform the hon. Gentleman and the House that it was not quite 10 pm when the debate began, and the motion for the Adjournment therefore had to be moved again at 10 pm. The hon. Gentleman is perfectly in order.

Mr. Prentice

I know exactly where I left off, Madam Speaker.

The disease was first identified in the 1860s by a French doctor. Until recently, it was regarded as untreatable, and no thought was given to how those suffering from it could be helped, advised and supported as its course progressed. I say "progressed", for, although the disease is at present incurable, many people are affected only marginally, if at all.

A quarter of those diagnosed as having MS are affected only mildly 15 years after the onset of the disease—they may have pins and needles in their fingers or toes—while a further quarter, tragically, end up in wheelchairs. The remaining 50 per cent. have the varied symptoms that characterise MS, which can include impaired co-ordination, problems with vision, loss of sensation and fatigue. One recently diagnosed constituent of mine told me that her arm sometimes felt as if it were full of molten metal. One in 15 people with MS will eventually become severely disabled.

MS typically affects more women than men, in the ratio 3:2, and strikes the young. That is what interested me in the condition in the first place. It hits people in the prime of life, often between the ages of 20 and 40. They have everything to look forward to; then comes the diagnosis that can change everything.

MS is common—it affects roughly one in every 1,000 people—but what causes it is still a mystery. No one knows why there are MS "clusters" in certain parts of the country, or why it increases according to latitude. It affects 99 people in every 100,000 in the south of England, but 178 per 100,000 in north-east Scotland. It used to be thought of as a disease that affected only Caucasians—and, curiously, non-white people who have settled here do not increase their chance of getting it, but their children acquire the risk faced by the general population. Many aspects of the disease are observed, but not understood.

Nevertheless, all is not gloom and despair. Things changed dramatically recently with the advent of new drugs that, it was claimed, would alter the course of the disease for those with relapsing-remitting MS, in which a person is free of the symptoms for a while but they often return with a vengeance. Peter Cardy, chief executive of the Multiple Sclerosis Society, wrote only a few months ago, in an article published in The House Magazine: For those who suffer severe relapses, the experience is like being dragged repeatedly to the jaws of death; blind, in pain and paralysed. Therefore, it is not surprising that the prospect of a drug that would deal with those dreadful symptoms has excited such interest.

Beta interferon helps people with remitting and relapsing MS—about 45 per cent. of the total number. The drug was given a product licence in December 1995, allowing it to be used not just in the UK, but throughout the European Union. In November 1995, the Department of Health issued guidelines on how it should be prescribed. I have read those guidelines cover to cover, and they put the frighteners on purchasers and on the consultant neurologist to whom would fall the clinical decision of whether beta interferon should be prescribed. The result of all that has been an enormous difference throughout the UK in the drug's availability.

The NHS guidance did not state categorically that all patients judged likely to benefit from the drug must receive it; the advice was much more circumspect. Providers—hospitals and so on—were asked to think about the resource implications of using beta interferon. It is expensive—£10,000 per patient per year—but we must set that against the annual cost to the economy of MS, which is about £1.2 billion in terms of lost taxes, increased benefits and so on.

Hospitals were told to consider workload and manpower implications for hospital neurologists and out patient departments. The guidance asks providers to consider the impact of providing the drug on waiting times, on consultant availability, on magnetic resonance imaging scans, on nursing and other support and, finally, on the hospital drugs budget. Couched in such a stern way, that advice clearly had an effect. In some parts of the UK, there was no access at all to beta interferon. On 10 December, I asked the Minister about the availability of beta interferon, and was told that that information was not collected centrally.

A survey was conducted by the manufacturer of the drug, Schering Pharmaceutical. It has a clear and obvious interest, but the figures it has provided to me are not necessarily tainted for that reason. The data relate to the period up to and including October 1996, almost a year after the initial guidance was issued, and just about the time that the latest and more positive advice went out from Dr. Winyard, medical director at the NHS executive.

The figures show the number of remitting-relapsing MS patients in each region and the percentage of purchasers—the health authorities—funding beta interferon in each region. In my constituency in the north-west, all health authorities make provision for beta interferon, which is good. Of course, there is a second hurdle. The consultant neurologist has to decide whether to prescribe it, but the health authorities have made a decision whether to provide the money to purchase beta interferon, so someone in Manchester with relapsing or remitting MS would be all right, but someone in Edinburgh or in Dundee would not. In Scotland, only 35 per cent. of health authorities make provision; in Wales, only 5 per cent. do so; and in the English regions, only 5 per cent. do so in the northern and Yorkshire region.

Mr. William O'Brien (Normanton)

I am grateful for the opportunity to intervene. My hon. Friend refers to North Yorkshire, but may I refer him to West Yorkshire, where I have constituents who need beta interferon?

Wakefield health authority is in financial difficulties, so, although the drug is prescribed for patients, because resources are not there, my constituents cannot receive that treatment. That is diabolical. People are suffering because of the lack of resources. I therefore ask my hon. Friend to include West Yorkshire in his diagnosis of the lack of resources in various regions.

Mr. Prentice

The Minister heard those remarks and will reply in due course. If I run through the English regions, I can put it all in perspective.

Mr. Allan Rogers (Rhondda)

My hon. Friend said that the incidence of prescription among authorities in Wales was only 5 per cent. What does he mean by that?

Mr. Prentice

It is the percentage of health authorities that make a decision to allocate in their budgets for the purchase of beta interferon. Only 5 per cent. of the health authorities in Wales have done so.

The figures for England are: 5 per cent. in the Northern and Yorkshire region, with 14 health authorities; 10 per cent. in Trent; 50 per cent. in the South and West area; 56 per cent. in the Anglia and Oxford region; 80 per cent. in the North Thames area; and 92 per cent. in the South Thames region. Someone is okay if they live in Northern Ireland, because the figure there is 100 per cent., but those in the West Midlands area are in dire straits, because not a single health authority in that region has decided to purchase beta interferon.

A letter from the chief executive of the MS Society, dated 6 January, to my hon. Friend the Member for Warley, East (Mr. Faulds) says: A year after the licensing of the product (Beta Interferon 1 B) there are still very few MS patients who are receiving the drug in the West Midlands. There seems to be a gap between policy and practice here". There is indeed a yawning gap. As of the middle of last year, only 160 patients nationally were being prescribed beta interferon.

Mr. Cardy said in his article in The House Magazine: It is frankly scandalous that whether you are treated for MS depends on where you live. That must be true.

Clearly, we do not want to go through this performance each time a new drug for MS is licensed. Other drugs are coming along which are available elsewhere, but not here in the United Kingdom. The licensing procedure should guarantee the effectiveness and the efficacy of the drug in question. In the case of beta interferon, that seems to be beyond doubt. It stretches the time between relapses by up to one third, and that is what people with MS care about. It does not necessarily stop the progress of the disease towards disability, but it does influence relapses.

Dr. Winyard wrote in the letter that was circulated to health authorities in October that no date had been set for the national trial, and I would like the Minister to comment on that. Why has a national trial to assess the impact of the drug on disability been pigeonholed? That is not good enough.

There are one or two other issues that I want to highlight in the time available to me. For example, there are not enough neurologists in the country. In a debate a few weeks ago instigated by my hon. Friend the Member for Stratford-on-Avon, the Under-Secretary said that there are 260 consultant neurologists in England and Wales, and added that the number had increased by 4.3 per cent. over the past five years.

The Parliamentary Under-Secretary of State for Health (Mr. Simon Burns)

That is 4.3 per cent. in each year.

Mr. Prentice

That is magnificent news, but clearly it is not enough.

When I intervened in that debate, I referred the Minister to a study produced by the Preston NHS trust, which has a neurology unit. The document, which is hot off the press, states that, if one is unfortunate enough to live in Lancaster, it can take six months to get an appointment or a referral to a neurologist. That needs to be seriously addressed. Waiting lists at clinics are simply far too long, as the maximum time—the MS Society tells me—should be one month. I think that that is reasonable, and the Minister should comment on the fact that it has been overshot so massively.

The second key area concerns the interface between the NHS and social services and the other support systems. That issue was also covered in the debate in January on neurological conditions.

The Multiple Sclerosis Society has drawn up a draft standard of care for purchasers and providers treating people with MS. It recommends how the illness should be handled at each stage of development, from the initial diagnosis, through the moderate disability stage, to the severe disability stage, for cases that tragically progress that far. The society's suggestion is already followed for other conditions for which standards of care are prescriptive. There is a standard of care if a person is suffering from diabetes, asthma, haemophilia or eczema, but not for MS or other neurological conditions.

It is an absolute disgrace that the Government have been so reluctant to fund properly research into multiple sclerosis. The Multiple Sclerosis Society has spent £30 million since it was set up in the 1950s on research into the disease. It is currently spending £8 million to fund 50 research projects. What have the Government allocated? Last year, they spent £216,000, the year before £207,000, and in 1993–94 £154,000. Those are sizeable sums of money, but they pale into insignificance when one considers the money spent by the society—a charity. The society says that it faces demands on its resources, and that it cannot be expected to carry the burden alone. It is looking for the Government to take a larger share.

I mentioned that other drugs are in the pipeline, including co-polymer 1, which was trialled in United States in 1994. It has had encouraging results. Another is cannabis. Every time I mention cannabis, my local press go berserk, as if I am being soft on drugs. However, masses of anecdotal evidence from people who suffer from MS suggests that cannabis helps them.

It was, of course, legal for cannabis to be prescribed by medically qualified doctors before the Misuse of Drugs Act 1971, and it was prescribed in tincture form. Under section 7 of the Act, it is now unlawful for a doctor to prescribe cannabis, yet heroin can be prescribed and is used in hospitals all the time for the relief of pain. I have also found out from the Minister for Health that an active ingredient derived from cannabis—dronabinol—has recently been rescheduled and can now be used, because it has been discovered that it could treat nausea in patients undergoing chemotherapy treatment for cancer.

I welcome the initiative that the Government have taken. I know that the Minister for Health has met the Multiple Sclerosis Society and is sympathetic, but more needs to be done. It need not cost a fortune to make services for people with MS seamless across the NHS and into the community. Wherever people live in the United Kingdom, they should have equal access to the treatment they need when they need it. At present, we have a national lottery, with too many losers.

10.18 pm
The Parliamentary Under—Secretary of State for Health (Mr. Simon Burns)

I should like to thank the hon. Member for Pendle (Mr. Prentice) for raising this important topic. As he said, multiple sclerosis is a complex and distressing condition, which is estimated to affect more than 80,000 people in the UK, often starting in early adulthood. It places a major burden on health and social services, and, most significantly, on the individuals who suffer from it and their carers, who play such a vital role in looking after family members or friends who, sadly, are afflicted with this condition.

My ministerial colleagues and I are committed to doing all we can to help the health service alleviate the symptoms of people with multiple sclerosis, so that they can get on with their lives, because unfortunately there is as yet no cure. That is why the Government are funding—through the Medical Research Council and the Department of Health—research designed to investigate the causes of multiple sclerosis and the effectiveness of new treatments, as well as research in the two broader areas of auto-immune diseases and diseases of the central nervous system, which both underpin MS research.

With respect, the hon. Gentleman was a little churlish when he talked about the Government funding of research for MS and other related problems. In the past six years, Department of Health and Medical Research Council funding for MS has amounted to more than £2 million. As the hon. Gentleman may be aware, the Multiple Sclerosis Society has made an application for section 64 funding, which is being considered by the Department. I hope that it will be able to decide and make an announcement in the not too distant future. The MRC is also funding research into auto-immune diseases. We are committed to providing resources from central Government to help with that research

I applaud the work that is being done by the Multiple Sclerosis Society, both in providing information, support and advice to people with MS and their families, who need this assistance now, and in looking to the future by funding a major programme of research. Its "Manifesto for Multiple Sclerosis" highlights the critical importance of co-ordinated care and of planning services to enable funding to be used more effectively, and that is a message that I wholeheartedly support. It is relevant to all NHS services, not just to those for people with MS, and it is at the heart of the purpose of the NHS: To secure through the resources available the greatest possible improvement in the physical and mental health of the people of England. We are gradually witnessing the emergence of new therapies for multiple sclerosis. In the past year or so, there has been particular interest in the development of the group of drugs known as beta interferons, as the hon. Gentleman said.

So far, only one beta interferon drug—a beta interferon 1b drug known as Betaferon—has been licensed for prescription in the United Kingdom. This drug received a European marketing authorisation in December 1995 and is licensed for use by certain people who suffer from the relapsing-remitting form of multiple sclerosis.

The drug is not a cure. It is not suitable for all those with MS. So far, our experience of it has been limited. However, it has been described as a "promising newcomer", and, in line with the Government's commitment to ensuring that patients receive treatments that doctors judge to be clinically necessary, it has been available under the NHS since it was licensed.

Mr. William O'Brien


Mr. Burns

I am sorry, I do not have the time to give way.

In 1995, following requests by a number of bodies that information about beta interferon would be helpful, the NHS executive issued circular EL(95)97 and clinical advice from the Standing Medical Advisory Committee to help the NHS plan for and manage the introduction of this new treatment. The guidance—a central framework to help the NHS reach decisions at local level—was developed with a number of key bodies, including the Association of British Neurologists, general practitioner representative bodies and the Multiple Sclerosis Society.

Briefly, the guidance suggested that, because of clinical considerations—that is, because beta interferon 1b was a new treatment—to ensure that it was targeted at those people who were most likely to benefit from it and to help monitor and evaluate its effectiveness, the treatment should be prescribed only by hospital neurologists where it was judged to be clinically appropriate, and within local agreements between health authorities and hospitals.

Arrangements are in place for assessing patients and, where appropriate, prescribing treatment. More than 300 patients in England are receiving beta interferon 1b through hospitals. That includes approximately 30 patients in East Lancashire health authority, which covers the constituency of the hon. Member for Pendle.

I am not aware of any health authority which is refusing to purchase or prescribe beta interferon. However, as with any procedure—but particularly when the procedure is new and still relatively untested—there is no single view within the NHS about the precise circumstances in which the treatment should be available. Consequently, prescribing across the country will not necessarily follow a uniform pattern. That is consistent with the arrangements for setting priorities and reaching decisions within the NHS.

It has been suggested that the Government should spell out at a national level precisely what treatments the NHS should provide. We do not think that that would be right. No list of treatments could ever hope to accommodate the range and complexity of the different cases that individual clinicians face all the time. Such a course would be too inflexible to take account of the different needs of individual patients, and would prevent clinicians and managers from carrying out different alternative approaches that could be of benefit to patients.

The Government have, however, made it clear that health authorities should not, as a matter of principle, decide not to use any clinically effective treatment. Even when the effectiveness of a procedure is not in general judged to be high, it might be both effective and appropriate in certain circumstances for an individual patient. That message was repeated in our recent White Paper, "The National Health Service—a Service with Ambitions".

I shall deal briefly with the point about the therapeutic use of cannabis. I shall write to the hon. Member for Pendle in the next few days about the issues with which I am unable to deal because of the time. My ministerial colleagues and I are aware of, and concerned about, the distress experienced by people suffering from multiple sclerosis, and we have carefully considered the representations made to us that cannabis should be made available for medicinal use.

The therapeutic use of cannabis is a complex issue, and it may be helpful if I address some of the most important considerations. Under section 7 of the Misuse of Drugs Act 1971, cannabis and certain other drugs are controlled, because it is in the public interest for their production, supply and possession to be either wholly unlawful, or unlawful except for the purpose of research or other special purposes; or for it to be unlawful for doctors to supply them except under licence from the Home Office. The controls imposed by the Act conform with the international restrictions covering those drugs.

We are committed to ensuring that patients receive the drugs they need to treat their clinical conditions. Before a cannabis-based medicine could be prescribed, a company seeking a licence would have to present the supporting data—which would have to demonstrate the medicine's safety, efficacy and quality—to the Medicines Control Agency, in the normal way. The MCA would then evaluate it, and, if it were able to approve it, notify the Home Office.

We understand the desire of people with multiple sclerosis to explore every avenue to seek relief. It would, however, not benefit those people if we were to disregard the procedures that have been set up to ensure the safety, efficacy and quality of prescribed drugs. We have to take account of all the considerations, including the potential risks associated with short and long-term use of cannabis, and consider whether any benefits—which must have been proven scientifically—outweigh those risks. We already know that there are side effects from the use of cannabis.

We have received a wealth of anecdotal evidence of the efficacy of cannabis in treating some of the symptoms of multiple sclerosis. A matter as important as people's health, however, should not be taken lightly, and hard, scientific, research-based evidence is required. The conclusions of available research are not very convincing, due to the limited scope of the projects, the use of small cohort groups, or the lack of suitable scientific methodology.

I understand that the Multiple Sclerosis Society has taken positive steps to encourage trials, by offering support to researchers. The main agency through which the Government sponsor medical research is, of course, the Medical Research Council, which is always willing to consider scientifically sound proposals.

Current legislation does not prevent research into the medicinal use of cannabis, provided that a Home Office licence has been obtained for that purpose. For the purposes of a clinical trial, which involves sale or supply of medicinal products and various other specified activities, a clinical trial certificate or clinical trial certificate exemption would also have to be obtained from the Medicines Control Agency.

We are therefore not in a position to allow the therapeutic use of cannabis. It is up to researchers and companies wishing to market a cannabis-based product to supply the necessary scientific evidence of its therapeutic value, if any, in the first instance. They would also have to consider the form in which cannabis could be made available for use as a medicinal product in a controlled dose. As long as we have no evidence, on the grounds that I have just outlined, it is not possible to allow the therapeutic use of cannabis.

Once again, I thank the hon. Member for Pendle. I appreciate, as he will know, that I have not dealt with every issue because of the shortness of time.

Mr. William O'Brien

Hear, hear.

Mr. Burns

There is no point in the hon. Gentleman saying, "Hear, hear," because it is not his debate; I was concentrating on the speech of the hon. Member for Pendle, because I appreciate the sincerity of his concerns about those who suffer from MS. The Government are equally concerned, and we are all determined to do all we can to alleviate the suffering that they sadly have to go through.

Question put and agreed to.

Adjourned accordingly at half-past Ten o'clock.