August 2010 Open door by MS Trust

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MS factsheets Regularly updated, we now have more than 20 titles available Bladder problems Cladribine Fingolimod Natalizumab (Tysabri) Sativex Spasticity and spasms Stem cells Vitamin D

We deal with a wide range of enquiries about MS from anyone affected by the condition. You could be someone recently diagnosed, someone with questions on specific symptoms or treatments or looking for news of research that has been in the press. We will gather reliable, independent information to help answer your questions, help you decide how to approach issues that concern you and have informed discussions with your health professionals. Our focus is on health information, but you can ask us anything about MS. If we are unable to find an answer ourselves we will try to direct you to other people better able to help.

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August 2010

Inside this issue...

Welcome to the summer edition of Open Door

School project

Making treatment choices

The phrase below 'bizarre and seemingly unconnected events' directed at Mike Laver's experience of being diagnosed with MS, could equally be applied to the contents of this edition of Open Door. Although it’s August, we have articles on skiing, schools, Sativex and Christmas cards. It is that time of the year when we offer free post and packing on our Christmas cards and like all our fundraising activities, they enable us to provide our information services free of charge to anyone affected by MS. It has taken nine years for Sativex to get a licence and it has been proven to help people living with severe forms of spasticity. However, already we are hearing of people refused it on the grounds of cost. Short-term gains can easily lead to long-term costs as people become less able, but short-term savings could become a common theme in this economic climate. We have outlined health priorities for people with MS on page 2 and we may all need to campaign hard to keep the services we have, let alone gain new treatments. The next generation of disease modifying drugs show positive results, but it is the fact they come as pills which has hit the headlines. Ultimately people will have to assess what they value most. The fact they are pills is possibly of least importance to people with MS when ranked against effectiveness and risk. Neurologist David Footit and a person with MS give their views on page 8.

Sativex

A wider choice of drugs and treatments is very positive, but having the information to make personal choices is going to be even more important and that’s where our information team come in - call us or email, we’re here to help. Very best wishes and thank you for supporting our work.

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Also inside:

Pam Macfarlane Chief Executive

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Health care priorities

News

“Bizarre and seemingly unconnected events”

Research news

Ex RAF helicopter pilot, Mike Laver, has worked with the MS Trust over the last three years helping to set up our successful Monster Ski fundraising events. On page 12 he writes about how his diagnosis with MS has changed his appreciation of what is important in life. More about next year's Monster Ski on page 15.

Voyage of discovery 12

A copy of the MS Trust’s data protection policy is available on request Return to: MS Trust, Spirella Building, Letchworth Garden City, Herts, SG6 4ET

Multiple Sclerosis Trust Spirella Building, Bridge Road, Letchworth Garden City, Hertfordshire SG6 4ET T 01462 476700 F 01462 476710 E info@mstrust.org.uk www.mstrust.org.uk Registered charity no. 1088353

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Health care priorities for the next decade

Following the general election, the new team at the Department of Health will face a range of challenges. The new Health Secretary is Andrew Lansley, and as he has held the shadow portfolio for many years he is possibly the best prepared Health Secretary for some time. He is joined by Paul Burstow from the Liberal Democrats, someone the MS Trust worked with back in 2001, and who has an interest in MS and long-term conditions. The budget for health has been protected in actual terms but we know that with the population dynamics of the country there will be an increase in demand which will ensure that money will be tight. The MS Trust hopes that the DH will share some of our priorities for the next decade, and we will be working hard to campaign to this effect.

Quality services for people with multiple sclerosis

The benefits of the Department of Health Risk-sharing Scheme must be maintained The Department of Health Risk-sharing Scheme is the legal framework for the prescription of the original disease modifying drugs. Some people with MS have done really well on drug therapy and all people with MS have benefitted considerably from the Scheme through the development of MS services. Early termination must not be considered without ensuring that access to MS treatments and services are legally preserved.

Growth in the number of therapists specialising in MS The Therapists in MS group, now an active force in MS management, must be encouraged to continue to develop new ideas of benefit to people with MS and the NHS.

Managers and commissioners have no real understanding of what it is like to have multiple sclerosis - they need input from clinicians and people with MS who do understand. We are currently preparing to repeat More money must be allocated our audit with the Royal College of Physicians to provide to MS services evidence of good and bad service provision. Neurology in total, and MS specifically, remain Cinderella services in comparison with other Growth in the number of hospital serious conditions such as cancer. Research by the MS specialist centres Kings Fund in 2006, showed only 3% of funds was allocated to neurology in England despite 8 million There are currently about 90 hospital specialist people having a neurological condition. Only 3% centres, but the number needs to grow to allow of the budget for 14.3% of the population - is this people with MS access to services closer to their home. See the MS Trust map for specialist centres at fair? Why should people with MS have a second class service in the UK compared to all other www.mstrust.org.uk/map developed countries?

Growth in the number of MS specialist nurses MS specialist nurses have the ability to make a major difference for people with MS and the MS Trust will continue to lead the campaign we started in 1997 for more specialist nurses across the UK. There are currently about 230 MS nurses - we need at least 100 more.

Health professionals and managers must involve people with MS in the development of services

New drugs to be assessed quickly and effectively by NICE

We know MS is a complex condition and a challenge for the NHS. However, just because it is challenging doesn’t mean the NHS can ignore it. The MS Trust has developed an MS pathway for commissioners that charts the needs of people with MS throughout the disease course and we hope this will provide a framework for future planning.

The new drugs on the horizon, if they are granted a marketing licence, need to be assessed by the National Institute for Health and Clinical Excellence (NICE), and then introduced effectively into the NHS.

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News

Sativex licensed In June 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) licensed Sativex for use as an add-on treatment for MS related spasticity when people have shown inadequate response to other symptomatic treatments or found their side effects intolerable. For more on Sativex, see page 10

Tysabri labelling information updated The labelling of natalizumab (Tysabri) has been amended to reflect the increased risk of a potentially fatal infection after two years of treatment. Tysabri is licensed for people who are experiencing severe relapsing remitting MS with several relapses a year. Although very effective at reducing relapse rates, it is associated with a rare but potentially fatal brain infection called PML. The risk of PML appears to increase with duration of treatment, particularly after two years. The patient information leaflet has now been revised to include information about the signs of PML, which are similar to some MS symptoms. The new information stresses the importance of contacting health professionals if people experience new symptoms.

Male continence problems guidelines published NICE has issued new guidelines on the treatment of bladder related symptoms in men. Around a quarter of men over 40 have continence problems - and amongst men with MS the proportion is much higher. The guidelines cover assessment and treatment along with recognition of the need to provide appropriate information and emotional support for symptoms that can have a profound impact on an individual’s independence and self esteem. National Institute for Health and Clinical Excellence. Lower urinary tract symptoms: The management of lower urinary tract symptoms in men. CG97 London; NICE: 2010.

Risk-sharing Scheme criticism ignores benefits to people with MS Articles in the BMJ in June branded the MS Risk-sharing Scheme “a costly failure” and called for it to be discontinued and the money spent elsewhere in the NHS. The Scheme was set up by the Department of Health in 2002 following the decision by NICE that the disease modifying drugs - beta interferon and glatiramer acetate - were not cost effective for use by the NHS. The Scheme involves a ten year study of the drugs, with the price being adjusted if they prove less effective than expected. In an accompanying editorial, Professor Neil Scolding acknowledged flaws but pointed out that the Scheme has spawned an extremely successful infrastructure of specialist MS care in the UK and that the drugs prescribed will have prevented thousands of relapses. Professor Richard Lilford, the chair of the Scheme’s Scientific Advisory Group, strongly rejected the suggestion that any advice given was based on anything other than scientific rigour. He also challenged the claims that decisions should be based on data after only two years. This is an important point as some press reports incorrectly took criticism of the Scheme to mean there are doubts about the clinical efficacy of the drugs. Prior to the Scheme, access was beset with problems of postcode prescribing and without it many people with MS would be denied treatment. Since its introduction, more than 14,000 people have been prescribed the drugs. Additionally, support for the Scheme has seen the development of multidisciplinary MS centres and a doubling in the number of MS specialist nurses improvements that have benefits for all people with MS. McCabe C, et al. Continuing the multiple sclerosis risk sharing scheme is unjustified. BMJ 2010;340:c1786. Raftery J. Multiple sclerosis risk sharing scheme: a costly failure. BMJ 2010;340:c1672. Scolding N. The multiple sclerosis risk sharing scheme. BMJ 2010 340: c2882. Lilford RJ. Risk Sharing Scheme could not yield valid data after only two years follow up.BMJ [rapid response on website]. 4 June 2010. Available from http://www.bmj.com/cgi/eletters/340/jun03_1/c1672

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picture: Nicholas Flook

Health care priorities for the next decade

Quality services for people with multiple sclerosis

Health professionals and managers must involve people with MS in the development of services

New drugs to be assessed quickly and effectively by NICE

www.mstrust.org.uk

News

Call: 01462 476 700

New treatments, new combinations tested

Research news

Results of a number of small studies investigating different treatments have recently been published. Here’s a round-up.

Combination studies:

Understanding what causes MS Identical twins study Identical twins are of interest to researchers studying the contributions of genetics and environment to disease. This study focused on three pairs of identical twins, in which one twin had MS and the other did not. Using the latest techniques to carry out a very detailed search, the researchers could find no genetic source for differences which could explain why one twin had developed MS while the other had not. Baranzini SE, et al. Genome, epigenome and RNA sequences of monozygotic twins discordant for multiple sclerosis. Nature 2010;464:1351-1356.

Vitamin D for MS prevention? An editorial in Lancet Neurology discusses the potential for vitamin D supplements to reduce the risk of developing multiple sclerosis. The article concludes that trials are needed to address the many uncertainties that remain. Because any benefits for MS could take decades to emerge, a long-term outlook is needed from policy makers. An extensive review of the evidence for a role of vitamin D in preventing and for treating MS is also published in this issue. Vitamin D: hope on the horizon for MS prevention? Lancet Neurology 2010;9(6):555. Ascherio A, et al. Vitamin D and multiple sclerosis. Lancet Neurology 2010;9(6):599-612.

Sunlight and MS In an Australian study, data gathered from 1,524 people with MS revealed an increased risk of developing MS for babies born in the summer, which the researchers linked to low sunlight exposure during the first three months of pregnancy. Low sunlight exposure may lead to low levels of maternal vitamin D at important stages of foetal development. Staples J, et al. Low maternal exposure to ultraviolet radiation in pregnancy, month of birth, and risk of multiple sclerosis in offspring: longitudinal analysis. BMJ 2010;340:c1640.

Using an animal model of MS, researchers have found that ultraviolet radiation dramatically suppressed the signs of MS. Only low, short-term changes in vitamin D levels were found which were considered insufficient to account for the effects of UV radiation. The authors conclude that UV radiation may have a direct effect in reducing MS-like symptoms, independent of vitamin D production, in this animal model. Becklund BR, et al. UV radiation suppresses experimental autoimmune encephalomyelitis independent of vitamin D production. Proceedings of the National Academy of Science 2010;107(14):6418-6423.

A separate study has reviewed recent research and proposed alternative mechanisms for the effect of sunlight on MS with particular focus on how sunlight modifies the antigens that trigger the autoimmune response in MS and how it may influence levels of other hormones. Mehta BK. New hypotheses on sunlight and the geographic variability of multiple sclerosis prevalence. Journal of the Neurological Sciences 2010; 292(1-2):5-10.

Do relapses lead to permanent disability? An understandable concern for people with relapsing remitting MS is that a severe relapse will leave them with permanent disability. This study investigated how often people experienced relapses that left them with significant disability, defined as an EDSS score of 6 and above (a standard measure of disability, level 6 indicates a walking aid is required) for a period of six months or longer. Records of 1,078 people with relapsing remitting MS held by a US-based MS centre uncovered 2,587 relapses. Only seven people had a relapse that resulted in sudden onset of severe disability from which they did not recover. Two of these severe attacks occurred in people who were taking disease modifying drugs, three in people who were not and two occurred at onset of MS. The researchers conclude that fear of severe relapses should not influence decisions to delay starting treatment or to stop treatment as such attacks are very rare and can occur whether or not people are being treated with beta interferon. Bejaoui K, et al. What is the risk of permanent disability from a multiple sclerosis relapse? Neurology 2010;74(11):900-902.

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■ Daclizumab is licensed for treating kidney transplant rejection and interacts with a number of cells in the immune system. The combination of daclizumab and beta interferon was significantly more effective than beta interferon alone.1 ■ Rituximab is licensed to treat leukaemia and nonHodgkins lymphoma. It is known to reduce the number of B-cells in the immune system and is being studied as a treatment for MS. Rituximab was added to standard disease modifying treatments in people whose MS was not adequately controlled. Based on MRI results, rituximab add-on therapy was effective.2 ■ Methylprednisolone is a steroid typically given either as tablets or infusion to speed up recovery from a relapse. Monthly pulses of methylprednisolone added to interferon beta-1a do not appear to affect disability progression any more than interferon treatment alone.3 In a review of combination therapies for MS, the authors note that although small preliminary studies suggested that combination treatment was safe, effective and with minimal side effects, subsequent larger studies have failed to support these initial findings. They conclude that although combination therapy remains an attractive option, its use has not yet been convincingly proven in MS, and there are several key unanswered questions.4

Neuroprotection in progressive MS ■ Animal studies have indicated that lamotrigine, an anticonvulsant drug that acts by blocking sodium channels, might have a neuroprotective effect. Brain volume measures of participants with secondary progressive MS treated with lamotrigine did not differ from those treated with placebo over the 24 month study. The participants had been diagnosed with MS for 18 years or more; an accompanying editorial suggests that neuroprotective treatments should be tested earlier in the course of MS.5 ■ Methotrexate is an immunosuppressant drug used in the treatment of cancer, arthritis and psoriasis. Intrathecal (an injection into the spinal canal) methotrexate, given to people with secondary or primary progressive MS, resulted in stable or improved EDSS scores measured one year after last treatment.6 1 Wynn D, et al. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurology 2010;9(4):381-390. 2 Naismith RT, et al. Rituximab add-on therapy for breakthrough relapsing multiple sclerosis: A 52-week phase II trial. Neurology 2010;74(23)1860-1867. 3 Ravnborg M, et al. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial. Lancet Neurology 2010;9(7):672-680. 4 Conway D, et al. Combination therapy in multiple sclerosis. Lancet Neurology 2010;9(3):299-308. 5 Kapoor R, et al. Lamotrigine for neuroprotection in secondary progressive multiple sclerosis: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Neurology 2010;9(7):681-688. 6 Sadiq SA, et al. Intrathecal methotrexate treatment in multiple sclerosis. Journal of Neurology 2010 June 10 [Epub ahead of print].

UK phase I stem cell study results published Researchers in Bristol have assessed the safety and feasibility of treating six people with stem cells derived from their own bone marrow. In contrast to previous studies, stem cells were not pre-treated to increase certain subsets of cells and participants did not receive treatments to suppress their immune system before their bone marrow stem cells were infused. Participants were followed up for a year and no serious adverse effects were found. Clinical measures indicated that their MS was stable. The Bristol team were encouraged by the results which now need to be investigated further in a phase II/III clinical trial with a longer follow up period. Rice CM, et al. Safety and feasibility of autologous bone marrow cellular therapy in relapsing-progressive multiple sclerosis. Clinical Pharmacology and Therapeutics 2010;87(6):679–685.

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New treatments, new combinations tested

Research news

Results of a number of small studies investigating different treatments have recently been published. Here’s a round-up.

Combination studies:

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Call: 01462 476 700

grant from the Wellcome Trust which will allow us to run for another year from September 2010.

Inspiring the researchers of tomorrow Sixth form scientists tackle MS research project

Wellcome Library, London

The Wellcome Trust award scheme centres on public engagement and we have endeavoured to spread the word about the project. We were invited to contribute a stand at the Royal Society Summer Exhibition last year. We had a fantastic time and were able to prove to a wide range of people that you are “Never too young to be a research scientist”. We have created and delivered four MBP2 DNA workshops for sixth form students from neighbouring schools to give them a greater appreciation of the techniques involved.

The project focuses on myelin basic protein (MBP), a major constituent of the myelin sheath. Myelin wraps round nerve axons in thin sheets and MBP helps to hold layers of the sheath together, acting as a kind of molecular Velcro. However, its structure can easily fall apart - for the technically minded this happens when phosphate groups get added to MBP (phosphorylation). This is bad news because when the fragile structure is distorted it plays a part in triggering the autoimmune response, ultimately causing the myelin sheath to come So there it is, MBP2 - the Myelin Basic Protein apart and preventing nerve impulses being transmitted Project. There are many aspects of this project that have exceeded my expectations. Particularly the through nerves. number of students who want to be involved and the enthusiasm and commitment shown by the Biology staff who have all worked tremendously hard to make this project happen. We want to find out what causes the phosphorylation events which affect the structure of MBP. MBP2 has proved that it is possible to provide students with an authentic research experience in How are we doing this? Well, basically we’re taking the school environment, carrying out practical work the human gene for MBP and genetically engineering they normally only hear about in lessons. This leads it into the yeast Saccharomyces cerevisiae, normal to a much better understanding of the science and brewer’s and baker’s yeast. Yeast cells have almost a much clearer idea of the careers open to them as the same biochemical pathways as humans - so we they move on to further education. expect the human MBP to be treated in exactly the same way as it would be in a human cell. This will give us a model for investigating what affects the structure of MBP.

So what are we doing?

picture: Terry Connolly

An ambitious collaboration between scientists and sixth form pupils is now in its third year at Simon Langton Grammar School for Boys in Canterbury. With help from their teachers and scientists at the University of Kent, A level science students are learning the necessary skills to run a genuine research project in the school labs. Dr David Colthurst explains the background. Three years ago, I knew almost nothing about multiple sclerosis; now I consider myself something of an expert on its symptoms, treatments, support and the research into new therapies. So what brought about this transformation? I’m not very good about remembering dates, but the one I do remember is 31 October 2007 - this was the day my wife received her diagnosis of MS. News like that takes a while to adjust to and it changes your perspective quite drastically. It also gives you the incentive to find out as much as possible about the condition. We talked with various health professionals including a specialist MS nurse and we visited the Kent MS Therapy Centre. This gave us answers to most of our questions about what we could expect of the next few months and years - but also made

us realise how unpredictable MS can be, that each person’s MS is their own unique variant.

Getting students involved Before I became a teacher I was a research biochemist and so I started to look at some of the root causes of MS. Reading the latest research, I came across a protein called myelin basic protein (MBP) that appears to have a role in maintaining the integrity of the myelin sheath. Myelin basic protein became my personal therapeutic target and I started to wonder if I could attract funding for a research project which I could get my sixth form students involved in. After a number of fruitless calls, it quickly became very evident that no school had ever tried to set up a project like this before. The only serious possibility was the Wellcome Trust - the largest nongovernment source of funding for biomedical research in the UK. They have a number of programmes to encourage public engagement in biosciences. With the help of colleagues at the school and support from researchers at the University of Kent I made a successful application for a People Award in July 2008. We recently heard that we have been successful in getting a second

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This is technically very challenging and it is only because of the close collaboration with the Biosciences Department at University of Kent that we have been able to shape our initial ideas into a workable project. Researchers from the labs have given up their time to help train students in techniques more commonly taught in the first or second year of an undergraduate degree. Students have taken days out of their normal timetable learning experimental protocols, how to use the apparatus and beginning to understand the theory behind the experiments. Co-ordinating the students has proved to be a considerable challenge in itself. In the first year, we had 60 students taking part, now we are in our second year there are 90. All Biology A level students, they have been divided into seven teams, each led by a student team leader and a member of the Biology staff and assigned a research mentor from the bioscience department at the University of Kent. Each team focuses on a specific aspect of the project and my task is to direct their efforts and assemble ‘the big picture’.

And what does my wife make of all this hard work?

She writes; “MBP2 became my torch in the darkness of disease - a positive focus and essentially a lifeline from the debilitating challenges of MS. Having witnessed and marvelled at a unique collaboration, pioneered by my inspired husband and embraced by the staff and pupils, I couldn’t help but view my disease more positively. “From my personal experience and understanding of MS, I have concluded that knowledge is power. MBP2 has proved a hub for empowering knowledge, sharing practice and enthusiasm for science with other schools and predominantly in the fight against disease, their knowledge is power. “Thank you MBP2 and thank you Dave.” If you want to follow our progress, you can keep up to date through the school newsletter on our website www.thelangton.org.uk or our own MBP2 website www.mbp-squared.org. Wellcome Library, London

Outside the school In addition to the project, we have been able to build strong links with the Kent MS Therapy Centre which is adjacent to our school. Many of our students volunteer their support to the centre and last year raised £2,680 through various fundraising activities.

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grant from the Wellcome Trust which will allow us to run for another year from September 2010.

Inspiring the researchers of tomorrow Sixth form scientists tackle MS research project

Wellcome Library, London

So what are we doing?

picture: Terry Connolly

us realise how unpredictable MS can be, that each person’s MS is their own unique variant.

www.mstrust.org.uk

And what does my wife make of all this hard work?

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Making treatment choices

picture: Horia Varlan

David Footit, Consultant Neurologist, Preston

New tablet gives fresh hope to MS patients... I can just see the headlines in the press as one of the ‘orals’ comes to market. The question is should all my patients simply form an orderly queue for their prescription of a wonder cure, or is there more to it than that? I guess most of you know the answer to this, but here’s how I’ll be approaching it with patients.

You don’t get ‘owt for nowt’, so there are downsides. As with anything interfering with the immune system there are concerns about infection, blood test abnormalities and malignancy, mainly of the skin. In the trials, fingolimod was occasionally associated with a slowing of the heart rate or macular oedema (an eye condition threatening vision); both these will require monitoring. Cladribine was associated with an excess of shingles infection.

What’s on offer? Well nothing yet, but two drugs are coming, perhaps within the year, and more are in the pipeline. Both work by suppressing the body’s immune response and have been tested in patients with relapsing MS. Sadly patients with progressive forms of MS will not benefit from them. There is some tantalising experimental evidence that some of the agents in development may promote remyelination, but as most people around MS have found out, what works for mice may not for men. Cladribine is already used as therapy for some forms of leukaemia. It works by interfering with DNA synthesis, damaging subtypes of lymphocytes thought to be important in producing MS relapses. The result of the CLARITY trial was that treatment with cladribine in short courses over two years reduced the average number of relapses per year from 0.33 to 0.15, compared to placebo. Fingolimod is a new drug which prevents lymphocytes from leaving the lymph nodes; as with cladribine, if the number of lymphocytes in the blood is reduced, brain inflammation will be less. The result of the FREEDOMS study showed that daily treatment with low or higher dose fingolimod reduced annual relapse rate from 0.40 to 0.17. The TRANSFORMS trial showed that both doses were superior to intramuscular interferon 1a - reducing average relapse rate from 0.33 to 0.18. For both cladribine and fingolimod there were also effects upon disability, but patients were only followed for two years, soXhyraGraf this has to be treated picture: with caution.

remember the suspension of natalizumab (Tysabri) just as it was about to launch in the UK. Even after a drug is licensed there may be delays - NICE will have to determine whether the treatment is cost-effective, and this may take time and the outcome is uncertain. I expect many people will still choose an injectable, and then consider at a later date whether to switch. The big question for those with an intermediate prognosis is whether the orals will mimic Nick Clegg and become a ‘game-changer’. The evidence for fingolimod being more effective than one of the injectables is quite compelling; cladribine has not been compared to another active drug. We cannot be sure about long term safety and effectiveness for either oral. For all the arguments about how effective they are, the injectables are certainly safe and generally well tolerated. For that reason alone many patients, and indeed neurologists may prefer to wait for others to test the water with the orals. The final group of patients to consider are those with aggressive disease, many of whom currently choose therapy with natalizumab. Clearly oral therapy will be more convenient, but will it be as effective? In the trials, the relapse rate on orals and natalizumab is comparable, however the relapse rate in the placebo patients was much lower in the trials of orals than in the natalizumab trials. This suggests that in the oral trials the patients had less aggressive disease. Until a trial is done comparing one with another we cannot say which treatment is more powerful, but I suspect the orals will prove to be intermediate between injectables and natalizumab.

Choice and information picture: Tony Camaiani

So what choices do I face with patients? The starting point, whether the patient is freshly diagnosed or on an established drug, is to attempt to predict what is likely to happen if we change nothing. As now, if my very best crystal ball suggests a reasonably good prognosis, ‘watchful waiting’ is probably the choice most patients will follow. Basically ‘if it ain’t broke don’t try to fix it’. Patients who have an intermediate prognosis and who meet criteria for ‘injectables’ have more of a dilemma - whether to hang on for the convenience of an oral or go with what they can have right away. Lots of factors come into play, but over the years experience has shown the vast majority can come to terms with needles, given adequate support. I will be reminding patients that drugs don’t always come as swiftly to the market as predicted and problems can arise even at the last minute - many will

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Choice was the buzzword in the noughties, offered by politicians as the means to improve services from education to the NHS. The trouble is that choice without clear information can become bewildering - anyone who has bought a mobile phone recently will know what I mean. The new options for MS treatment are of course welcome, but as a doctor I still can’t give a clear answer to the question every patient wants - which drug will best reduce my chances of disability. When I left the shop with my shiny new phone I had a sneaking feeling there was something better in there for me, but I had missed it. Now more than ever it will be vital that patients get sufficient time with their neurologist and specialist nurse to come to the decision that suits them best.

Treatment choices the point of view of a person with MS I currently take one of the injectable disease modifying drugs. Although initially not keen on the idea of regularly injecting myself, I have come to terms with needles, am able to manage the side effects and have been relapse free for over three years. The idea of an oral treatment is a very attractive proposal. However, the lack of long-term safety data and the growing list of side effects that are being talked about make me very cautious of even bringing up the possibility of an oral treatment with my neurologist at the present time. I don't think I want to be faced with making that choice just yet. I can't guarantee I will feel the same if my disease progresses more quickly. If I started to have more frequent relapses, I might be inclined to take a more 'risky' approach and push for one of the new treatments. At the moment I'm not sure if that would be Tysabri or one of the orals. My gut feeling is for Tysabri. Despite the risk of serious side effects, at least more is known about this drug and procedures are in place to spot problems early. When I was choosing which of the injectable drugs to take, my neurologist told me they were all pretty much the same and left the decision up to me. The risks and benefits of the new drugs are very different from what is already available. It's not just a case of preferring a pill to an injection but understanding what the drug will do to me and what will be the implications for future treatment if I chose one drug and not another. I would want a lot more input from my neurologist when making this decision. picture: Marcel Germain

The MS Trust has books and factsheets on current and anticipated disease modifying drugs. These can be ordered from the back page.

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Making treatment choices

picture: Horia Varlan

David Footit, Consultant Neurologist, Preston

Choice and information picture: Tony Camaiani

www.mstrust.org.uk

The MS Trust has books and factsheets on current and anticipated disease modifying drugs. These can be ordered from the back page.

Call: 01462 476 700

The future of cannabis medicine?

Sativex

However, the best might yet be still to come. It was noted during the CAMS study that those who were taking active cannabis, as opposed to the dummy placebo, seemed to be experiencing a slowing of progression in their MS disease course. For this reason, since 2006 the MS Trust has contributed £150,000 to the subsequent CUPID trial in which almost 500 people with progressive MS are taking part. Maybe cannabis can do more than alleviate pain and spasticity?

With the recent granting of a licence to Sativex as a treatment for MS related spasticity, Chris Jones, MS Trust trustee and former chief executive, reflects on the long process to get cannabis based medicine accepted.

At last, a licensed, legal cannabis based medicine... Queen Victoria’s personal physician, Sir Russell Reynolds, prescribed cannabis for menstrual cramps. In The Lancet in 1890, he claimed that cannabis, “When pure and administered carefully, is one of the most valuable medicines we possess.”1

If it was good enough for Queen Victoria... The fact that Queen Victoria found cannabis beneficial must be the only argument that the MS Trust has NOT used during the long struggle to allow people with multiple sclerosis legal access to a cannabis based medicine. Back in 2001, when a body as august as the Science and Technology Select Committee of the House of Lords recommended legalisation of cannabis for medicinal purposes2, we thought it might not be too far away. The committee had accused the Medicines Control Agency (MCA), which licenses medicines, of dragging its feet and said that their stance could delay the introduction of cannabis based medicines by up to three years. They just might have had a point; it’s taken nine.

Whose MS is it anyway? For me, the argument has always been simple. Decisions by the MCA are often based on a ‘one size fits all’ model. As we know, one size NEVER fits all with MS - it is a hugely variable condition with variable responses to treatments. People with MS should have had - long since - the right to decide for themselves whether they benefitted from cannabis medicine. The fact that there was so much anecdotal evidence - and not an insignificant amount of scientific evidence too - should have counted. Instead of which, time and again, appeal after appeal, we were confronted with clinical measures so blunt as to be virtually useless, and yet more demands for more evidence. At the appeal to the MCA in July 2007, as a person with MS trying to present a case, I went quickly from nervousness to anger. Two things caused the anger. Firstly, the fact that the appeal panel seemed to have little knowledge of MS, and certainly no understanding of what it means to live with MS. Secondly, the fact that credence was given to the test administered by doctors to assess improvement in spasticity, whereas the socalled PROM (patient reported outcome measure) used in the trial was judged unreliable. The doctors’ spasticity assessment was the Ashworth Scale - a measure generally discredited by medics and physios alike as being insensitive because it has only five points on its scale (where no spasticity is 0 and complete inability to move a limb is 4). How many people with MS only experience severe spasticity when they go to bed? I am of course delighted that at last common sense has prevailed. But I am still angry at the amount of time and resource that has been expended to get to the position we should have been in nine years ago.

Research funded by the MS Trust

picture:Mohammad Reza

Over the past 10 years, the MS Trust has contributed significantly to the body of knowledge on cannabis. The majority of research trials have focused on relieving symptoms of MS and we have funded work on cannabis use in advanced bladder dysfunction3 and also, as part of the CAMS trial on MS spasticity, looking at any unwanted psychological side effects of cannabis medicine.4 No significant psychological side effects were found.

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1. Russell Reynolds J. On the therapeutical uses and toxic effects of cannabis indica. Lancet 1890;135 (3473):637-638. 2. House of Lords - Science and Technology Committee. Therapeutic uses of cannabis: Science and Technology - Second Report. HL 50. London: March 2001. 3. Brady CM, et al. An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis. Multiple Sclerosis 2004;10(4):425-433. 4. Zajicek JP, et al. Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up. Journal of Neurology Neurosurgery and Psychiatry 2005;76(12):1664-1669.

What is Sativex? In June 2010 the UK Medicines and Healthcare products Regulatory Agency (MHRA) licensed Sativex for use as an add-on treatment for MS related spasticity, making it the first cannabis based medicine to be licensed in the UK Sativex is a mouth (oromucosal) spray containing chemical extracts derived from the cannabis plant: delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Cannabis plants are thought to contain more than 60 such chemical extracts (cannabinoids) - but these two have been studied for their effects in MS.

Who can be prescribed Sativex? The existing oral medications that are used for the treatment of MS spasticity - including oral baclofen and gabapentin - continue to be used as first line treatments for MS spasticity. It is only where these treatments offer inadequate relief or have unbearable side effects that Sativex may be considered. Sativex is licensed as an add-on therapy - meaning that it will be prescribed in combination with other anti-spasticity medications. Sativex must be started and supervised by a specialist with experience of treating people with MS spasticity, such as a neurologist, rehabilitation consultant or pain specialist. GPs should only prescribe Sativex when instructed to do so by the specialist.

How effective is Sativex? How does Sativex work? The way cannabinoids work is not fully understood as yet but discovery of the endocannabinoid system has provided some insight. This is the system of receptors found in the human body through which cannabinoids are able to exert their effects. It is thought to work in a similar way to the opioid system - the system that controls pain.

How is Sativex taken? Sativex is taken as a mouth spray. The severity of spasticity symptoms varies from one person to another so the number and timing of sprays will also vary. At the start of treatment the prescribing doctor will advise on frequency and timing of sprays and may suggest a gradual increase until the most effective dose is found

As with many medicines used in MS, Sativex does not work for everyone. In clinical trials, around half of people taking Sativex showed improvements in their symptoms within four-weeks of taking the medicine. Those people who did not show improvements were deemed non-responders and stopped treatment. A phase III trial found that about three quarters of those responding to Sativex reported an improvement of greater than 30% in their spasticity score at least once during the first four weeks of treatment. Collin C, et al. A double-blind randomized placebo-controlled parallel-group study of Sativex in subjects with symptoms of spasticity due to multiple sclerosis. Neurology Research 2010; 32 (5): 451-459.

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The future of cannabis medicine?

Sativex

Research funded by the MS Trust

picture:Mohammad Reza

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Call: 01462 476 700

Order the MS Trust’s Sativex factsheet from the back page

Voyage of discovery

In adjusting to life with MS I have made some discoveries. I feel that MS is not what defines me, but is only part of who I am. I don’t think dwelling on MS helps me, so I don’t. It lingers, but it doesn’t dominate.

Mike Laver After a few bizarre and seemingly unconnected events over the years, I think I had my first real inkling that there was something wrong with me when I made a simple fuel miscalculation when I was flying in Iraq for the RAF in 2004. While it was on the safe side of an embarrassing disaster (I calculated we didn’t have enough fuel to reach the next refuel location when we had just sufficient) it kept on nagging away at me as to why I had made that mistake. As a pilot flying a helicopter with limited range, you dwell on how much fuel you have, constantly. Despite debriefing myself over the next few days I never could reach a satisfactory conclusion as to why I had made the simple cognitive mistake; I had just got the sums wrong. Eventually, I put it down to simple tiredness. At the same time I had lost all feeling in one of my toes not a big enough event to alarm me but one that again came under the column marked ‘bizarre and seemingly unconnected events’. By then, there was quite a list.

Diagnosis I thought nothing of these events until I was lying in the hospital bed in October 2005 having lost all (and I mean all) feeling in my legs. The houseman in A&E had prodded me with needles, and tested me with heat and cold but I had no sensation of anything he was doing to me. After a week or so of tests and an MRI scan, I was told, somewhat in passing, that no, it wasn’t a tumour on my spine; I wasn’t even aware that that was what they were looking for.

on his light board and all I could see were a number of white ‘blobs’. Familiar? After a lengthy explanation, of which I listened to and can remember very little, he told me I had multiple sclerosis. In fairness, what I do remember him saying was, ‘of all the neurological conditions I would want to tell you you had, it would be multiple sclerosis’. Personally, although my wife may take issue, I’d settle for a mild dose of Tourettes. It was, however, sage advice and some I would pass on to others to help keep things in perspective. Professionally this was the end of my world. While I suspected that the RAF would stop me flying, I was still a little surprised when they did as it was obvious to the neurologist that I had been suffering from (and flying with) MS for over 10 years. But, with the emphasis on overseas operations, my military medical category also prevented me from undertaking any further operations. I would become what is known in the military as ‘self-loading baggage’. With my mind made up to accept the inevitable, I was discharged from the RAF in June 2008. The decision for me was made easier when I was gently nudged by one of the drug company DVDs you’re sent when choosing your interferon/glatiramer acetate; in it, one chap with MS basically said, ‘change jobs, get a life and enjoy yourself’. More sage advice.

Monster Ski By then I had created my own coping strategy, resolving to stick my finger in the eye of MS. This involved flailing myself to raise funds for MS, as this is what the condition needs more than virtually anything else. My brother and I came up with the idea of ‘Monster Ski’. In concept, this was a mammoth skiing challenge to ski over 150,000 vertical feet in six days. I thought that if I, as someone with MS, could achieve the challenge, then anybody else could do so too (although knowing how to ski would certainly help!). After proving the concept, and raising over £27,000, in 2007 we approached the MS Trust to suggest that they take it on as one of their annual fundraisers. They recently completed their third challenge in Whistler in Canada, with 16 people taking part. Monster Ski has raised over £250,000 for the Trust since we started.

The best advice I ever gave to anyone was ‘everyone deserves a second chance’. That person is now the Master of the Household for The Prince of Wales and The Duchess of Cornwall. He deserved his second chance and you deserve yours. It is still a beautiful world. Be cheerful. Strive to be happy.

Life with MS In adjusting to life with MS I have made some discoveries. I feel that MS is not what defines me, but is only part of who I am. I don’t think dwelling on MS helps me, so I don’t. It lingers, but it doesn’t dominate. I have found that my cognition is now not very good and I prefer simple take it or leave it decisions rather than having to make up my mind from a selection. I know this makes me come across as somewhat analogue but...

Six weeks later, after an MRI scan of my brain and nerve impulse tests, I saw the same neurologist in his consulting room. The brain scan slides were up

I’ve also found that dinner party conversations have a particularly random nature for me. While I see the connections between what has just been talked

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Since diagnosis, I have changed my appreciation of what is important and what is inconsequential - and there is a lot of that. Part of this has been through the voyage of discovery that MS has provided me with. I have learnt as much about myself as I have about the condition and I have been surprised by what I’ve discovered. What I consider now as having value and worth has changed fundamentally. It has been a refreshing journey and, while having MS is not exactly the best thing that has ever happened to me, it is not a counsel of despair either. While some doors have closed, MS has opened new doors to me and the new experiences I have been able to have, have been life-enhancing. These include deepening friendships, starting new ones and finding that I had and still have more of a contribution to make to other people’s lives than I ever realised.

For me Monster Ski is as much about raising the profile of MS as it is about raising funds. If there are any ‘take aways’ from Monster Ski it is that: MS need not hamper your ambition; you need not use MS as an excuse as to ‘why not’ but can use it as to ‘why’; and, that a good way of re-calibrating yourself is to do something for others rather than just focusing on yourself and your condition.

My next visitor was the neurologist, who asked me simple stuff like ‘have you ever experienced such and such...’. After answering ‘Yes’ to about 17 of his 20 questions, he told me he knew what ‘it’ was but that I would need a couple more tests to make absolutely sure and he gave me a temporary diagnosis of post-viral myelitis. I was then infused with steroids over the next three days and, with some feeling returning to my legs, sent home.

about and the stunningly interesting, esoteric and informative point I make, the other guests don’t and the conversation doesn’t even skip a beat until it’s back with their theme. I’ve learned to accept their sideways glances and hope they’re thinking more savant than idiot. Oh yes, I have a few more other symptoms too.

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Voyage of discovery

Six weeks later, after an MRI scan of my brain and nerve impulse tests, I saw the same neurologist in his consulting room. The brain scan slides were up

I’ve also found that dinner party conversations have a particularly random nature for me. While I see the connections between what has just been talked

www.mstrust.org.uk

Call: 01462 476 700

Supporting the MS Trust

Free p&p on our Christmas cards during August Avoid the Christmas rush and save yourself some money by ordering from our fantastic selection today! 100% of the profit goes towards the work of the MS Trust and with each card you send you are raising vital awareness of multiple sclerosis. This year we are also offering MS Trust diaries; stocks are limited so don’t miss out!

Did you know... for just £5, we can provide a family with information to help everyone understand MS? Our guides for teenagers, young children and parents can help parents and kids talk about how MS could affect their family.

Oundle School goes the extra mile Pupils at Oundle School have taken part in a 24 hour non-stop run to help the MS Trust support people with MS. This is the second year the event has taken place and the pupils involved have now raised over £6,900 to fund our work. The run was organised by sixth formers Zoe Kier and Stephanie Smith and involved 17 girls running in pairs for three hours each, over a 24 hour period.

“My daughter now knows that we are going through the same as many other families, and she is not alone. Thank you.”

After the run, the girls told us, “Everyone ran over 20 miles, with the furthest distance run by Emily Kier at 26.5 miles (over the marathon marker)! Everyone really felt the effects today though, having not got much sleep and running their hardest all throughout the night.”

Could you volunteer for the MS Trust in your local area? Without the help of our supporters, the MS Trust could not carry out its vital work in providing information and support for people affected by MS. We are looking for volunteers across the UK to represent us in their local communities and raise much needed funds for our work. Here are some ways in which you could help us in your area:

As well as this endurance running challenge, the school has been fundraising in other ways. Over £200 was raised through an auction at a dinner arranged by Noah Wood and the boys of Fisher House. “We are extremely grateful to everyone at Oundle who has been involved in fundraising for the MS Trust. The money raised at the school will help us provide information and support for families affected by MS, whenever they need it.” Pam Macfarlane, Chief Executive

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The MS Trust has joined forces with over 140 charities in a campaign to raise awareness of how vital legacies are to the future of good causes in this country. At present 67% of the UK population support charities, but only 4.3% include a charity in their will. During Remember a Charity Week, charities will be pooling their resources and working together to show what a difference even a small gift can make. “If the MS Trust has helped you, why not help them to help others after you’ve gone? By leaving a legacy I hope to help them continue all their good work.” Jo Addyman

Skiers take on a Monster challenge Following on from Mike Laver’s article on page 12, we would like to say a huge thank you to Mike and the 15 other skiers (pictured) who took to the slopes of Whistler back in April for our third Monster Ski challenge. Our team raised over £30,000 to fund the MS Trust’s work and collectively skied the height of Mount Everest more than 80 times over! Read more at www.mstrust.org.uk/monsterskiblog “I’ve just about recovered from the Monster Ski challenge! What a fantastic week... fantastic place, fantastic friends, fantastic charity.” Keith Miles, Monster Ski 2010

Monster Ski, Tignes: 3 -7 February 2011 Experience the exhilaration of Monster Ski for yourself! Our fourth ski & snowboarding challenge will take place in the French resort of Tignes. If you're confident on a red run, join us for this unique 3-day endurance challenge and help support people living with MS today.

■ Being a charity spokesperson

Registration fee: £150 Minimum sponsorship: £1,700

■ Representing the MS Trust at local cheque presentations

www.mstrust.org.uk/monsterski picture:Jérémie Pontin

■ Organising your own charity events

Remember a Charity Week: 13-19 September 2010

If you would like more information on how you can include the MS Trust in your will, please get in touch or visit www.mstrust.org.uk/wills

Pedal for MS Cycle India: 3-12 November 2011 We are pleased to announce our latest overseas event - an exhilarating cycle ride through rural Rajasthan, with a visit to the Taj Mahal! The ride will take you through the Aravali mountain range, dotted with tribal villages and temples, and through the Ranthambore National Park where you should see some fascinating wildlife - and possibly even tigers! It promises to be the trip of a lifetime, but will also be a real challenge with rides of up to 85km per day. Contact us now for more information. Registration fee: £299

■ Setting up a fundraising group

Minimum sponsorship: £2,800

■ Collecting for the MS Trust in your local area

www.mstrust.org.uk/india

■ Distributing posters and leaflets If you would like to become a valued member of our team, we would like to hear from you. Please email volunteer@mstrust.org.uk or call us on 01462 476707

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To find out more about supporting the MS Trust, please call 01462 476707, email fundraising@mstrust.org.uk or visit www.mstrust.org.uk/fundraising.

Call: 01462 476 700

Supporting the MS Trust

“My daughter now knows that we are going through the same as many other families, and she is not alone. Thank you.”

Order before 31 August for free postage & packaging www.mstrust.org.uk/christmas

■ Being a charity spokesperson

Registration fee: £150 Minimum sponsorship: £1,700

■ Representing the MS Trust at local cheque presentations

www.mstrust.org.uk/monsterski picture:Jérémie Pontin

■ Organising your own charity events

Remember a Charity Week: 13-19 September 2010

If you would like more information on how you can include the MS Trust in your will, please get in touch or visit www.mstrust.org.uk/wills

■ Setting up a fundraising group

Minimum sponsorship: £2,800

■ Collecting for the MS Trust in your local area

www.mstrust.org.uk/india

■ Distributing posters and leaflets If you would like to become a valued member of our team, we would like to hear from you. Please email volunteer@mstrust.org.uk or call us on 01462 476707

www.mstrust.org.uk

To find out more about supporting the MS Trust, please call 01462 476707, email fundraising@mstrust.org.uk or visit www.mstrust.org.uk/fundraising.

Call: 01462 476 700

MS Trust Information Services

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The core of what we do is the personal information service. We believe that people with MS should have the opportunity to be actively involved in the management of their condition.

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August 2010

Inside this issue...

Welcome to the summer edition of Open Door

School project

Making treatment choices

Sativex

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Also inside:

Pam Macfarlane Chief Executive

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Health care priorities

News

“Bizarre and seemingly unconnected events”

Research news

Voyage of discovery 12

A copy of the MS Trust’s data protection policy is available on request Return to: MS Trust, Spirella Building, Letchworth Garden City, Herts, SG6 4ET

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